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Your admission request will be pending for approval when you first register and create a member profile. After the verification of your qualifying score, you will be invited to complete your profile in order to become a member of NOUS High IQ Society. Applications without proof of qualifying score will not be accepted and the temporary profiles will be deleted. Potential members of NOUS High IQ Society are advised to send proof of their qualifying IQ scores on any of the accepted IQ tests (especially for the supervised tests the proof should be accompanied by the contact information of the psychologist who administered the test) to the following e-mail address: admission@nousiqsociety.org.
Member profile feature is not available at the moment due to long-term system upgrade.
All test information is strictly confidential. Only 1st and 2nd attempts are accepted. Online tests which allow multiple submissions are not accepted. The admission will be based on the official norms of the submitted IQ tests, therefore preliminary norms are not accepted.
The final acceptance of an IQ score or a potential member lies in the judgement of the administrator. IQ scores which are proven cases of cheating or cooperation will not be accepted.
All online unsupervised tests will not be accepted. Please refrain from sending scores on online tests of any kind. Unreal scores on psychologist tests will not be accepted. High range test scores will be evaluated before acceptance.
Our security policy requires verification of your identity. Therefore, we will require from all potential members a scanned image or a photo of their ID card/passport/driving license/student ID. All information is strictly confidential. For security reasons unverified members will not be accepted.
Society is supported by donations. Lifetime membership is provided after you donate 20€ using the PayPal button. Each membership status upgrade will require a donation of 20€. Your membership certificate will be determined from your membership status.
All accepted membership requests will be processed within 10 days. You will be notified to complete your profile.
Please read carefully the admission instructions before sending your requests for joining NOUS High IQ Society. Rejected and incomplete requests will not be processed or answered.
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Taylor Swift as Rapunzel Is a Disney Dream: See the Annie Leibovitz Photo!
If there was ever any doubt that Taylor Swift led a fairy tale life (with maybe a few more Prince Charmings than we remember), well, the proof is in the picture.
The single once more singer is the latest star to get into character for Disney Parks, starring in a dreamy new print campaign shot by Annie Leibovitz.
And for someone whose hair gets almost as much press as her personal life, it's only fitting as to which character from the Disney archives she was tapped to portray.
Taylor's back in London—find out if a Haylor reunion is in the works!
In the photo, commissioned by Disney and taken on June 20, 2012, in Culver City, the lusciously locked singer is seen hanging out (literally) of a castle's mossy tower, daydreaming, no doubt, of her knight in shining armor prince, while hanging out (not so literally) with every princess's BFF: some birds.


As many as 978 million people in 20 countries lost money to cybercrime last year, according to a new report by security firm Norton.
The individual impact: Norton says that victims lost an average of $142 to hackers in 2017, and that each victim spent almost 24 hours dealing with the fallout.
How the US was hit: The report claims that 143 million Americans were affected by cybercrime in 2017, losing a total of $19.4 billion.
The big threats: The leading technique used to extort money from consumers was malware—including things like ransomware and cryptojacking. But fraud and password loss were also big hitters.
Why it matters: Norton says that people are overconfident about their own cybersecurity chops. It’s a reminder that we should all be more vigilant online.


The loss of a key employee, a backlog of old AR, practice growth, expanding or opening a new office locations, current physician billing service problems or a desire to increase cash flow can all lead to a practice needing some extra hands when it comes to their medical billing.
In these types of situations it is critical that the practice is willing to seek help. Trying to get out of these circumstances on your own can be overwhelming. The strongest office managers know there is no shame in asking for a “helping hand” during crunch times.
· The help can be given quickly, from a company that can not only handle the volume of your business, but can do so in a timely manner.
· The “extra hands” cause minimal interruption or risk to your current cash flow and processes.
· The help provides vital value beyond the pressing crisis, and gives you the most value for your dollar. True medical billing experts bring a fresh eye and state-of-the-art knowledge about the billing industry.
The best way to achieve these objectives is to find an outside company who will start by working on the AR that is over 60 days old, in addition to the current dates of services. By working the old AR, this will show the source of lost cash flow and give relief to a great point of aggravation.
Knowing when to seek help, and understanding the type of help you need can turn a potential disaster into a conquest that will please physicians, provide immediate relief for the practice, and set you up for on-going medical billing and collections success.
Applied Medical Systems has been caring for the health of practices for more than 30 years by providing billing, coding and physician practice management services solutions to various healthcare specialties across the U.S.; including hospitals, private practices and emergency department physician groups.


Have you seen all of the fabulous repurposed crib projects out there? I am amazed by how creative people are. My two-year old has outgrown his crib and he has an amazing triple bed my husband made waiting for him. You can see pictures of the fabulous triple bed and their nautical room here.
I have been dreaming of all the wonderful project that I could make with his old crib. I love repurposed projects! They make me feel so green and we save money. We made two projects with our crib: my husband made something really cool (stay tune for that project) and I made this Photo Wall Display. We bought the crib used and it served it’s purpose for two years and I love that we can still get some use from it.
What you need to do first is take the crib apart. Ours was really easy to take apart with screws on each corner. Then take the crib railing and hang on the wall. I wanted to paint it but my husband knows I like to change the house around so he suggested that we leave it as close to its natural color so that when we are done with it we can put it back together and sell it. He’s knows me well.
We used to hooks that were the perfect size to keep the crib railing up on the wall.
Once you have it on the wall you can start adding your frames. I just used the picture stand attached on the back of the frame to hold the picture up in each slot. No need for nails.
I especially love my DIY $1 frames make over. You will never guess what I used to for the design cover on the frames. Stay tune for the details.


When I firstÂ saw a picture of this undeniably creative hot dog cake, my first reaction was that it would be great to take to a barbecue or other cookout where real hot dogs are already on the menu. The cake is made by sculpting a pound cake into a hamburger bun shape and laying a generously frosted cake hot dog in the middle of it, to be topped with yellow icing “mustard” and gumdrop “onions” and “relish.” It looks oh-so-festive, doesn’t it?
My second reaction to this cake was one of mild disgust because the “hot dog” is made of Twinkies. Twinkies might be tasty (albeit unhealthy) snack cakes on their own, but the idea of a cream-filled hot dog – even one that is just made up to look like a hot dog – is just not appetizing.
Still, I’d definitely attempt this creation with homemade counterparts for a bbq. I’d start with a basic pound cake, carve out the bun, then shape the carved out portion into my “hot dog,” rather than adding Twinkies into the mix.


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The free tips list at bettingexpert is the place to visit for both the best and broadest tips in online betting. You ll not only find betting tips with detailed analyses for the most popular sports, leagues and tournaments from across the globe but equally as insightful and profitable tips for more obscure leagues and tournaments.
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Italy is facing a crisis in the health sector, as around 53,000 nurses are needed across the country. The alert is provided by the Nurses Order, according to which the active nurses are obliged to attend up to 11 patients simultaneously, even in some areas a nurse is responsible for up to 17 patients.
According to the Nursing Order, in the analyzes of all regions of Italy, the most positive results are presented only in some northern provinces where a nurse is registered for three patients. The situation is also worrying in Lombardia, where there are the best hospitals in the national level, but there are about 4800 nurses in these hospitals.
According to the authorities, these figures have serious consequences, as risks increase for the sick but also for the nurses themselves. The fact that about 40 percent of Italian nurses are forced to spend extra hours to cover the needs of patients, explains a lot.
The Order of Nurses requires the issue to be resolved and called an urgent meeting to review this situation with Health Minister Giulia Grillo, and representatives of all Italian provinces. Of course one of the alternatives to solving the crisis is the recruitment of nurses in neighboring countries, such as Albania.


Of the five phones that Nokia introduced on Sunday here at Mobile World Congress 2018, the Nokia 1 doesn’t stand at the front of the feature queue. Instead, it’s built for anyone who wants an affordable easy-to-use phone, primarily for (gasp) making calls, but still wants to be able to be able to go online, take a photo and listen to tunes.
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Analysing networks in Australian Federal Parliament Hansard.
Using medical images to seed eye tests.
Teaching robots to do card tricks, and other tricky things.
Middle-ware to control NAO robots from Android phones.
And if you are a bean counter: my Google Scholar Profile.
I am a member of the Clinical Psychophysics Unit run by Dr Allison McKendrick.
A book coauthoured by me.
Here is my minimum-redundancy (Huffman) coder.
How do people use snippets in Web search result lists?
What does it mean to judge a document relevant to a query?
Australian Document Computing Symposium 2007. Australian Document Computing Symposium 2008. ADCS2008. ADCS2010. Australian Document Computing Symposium 2010 SPIRE 2008 20th International Visual Field and Imaging Symposium, 2012. IPS 2012. IPS Melbourne 2012.
Last modified Tue 13 Nov 2018 17:03:44 AEDT .


Suppose you apply for a big job. A very important job. .
You get your resume together. You make yourself sound indispensable to the new employer. You file an application and several days later the company HR director calls you in for a talk. You are not surprised to learn you’re not the only applicant. The competition is going to be pretty stiff. But you go in and meet the HR person who thinks you’re worth a talk with one of the office managers of this big company. The HR person warns you this person is kind of tough so you ask some friends to speak up on your behalf. They and you are persuasive enough that the office manager sets up a meeting with the Division Director. But the office manager tells you to lose the sport coat, get a suit and a new tie, and shine your shoes. The competition gets tougher the higher you go and you want to make sure you stand out enough to be memorable to the Division Director.
The Division Director takes a good look at you, listens to you state your case, and confers with assistants who have watched the interview. The group likes you but suggests a few tweaks you can make in your presentation and your personal appearance. Maybe they suggest a few additional details would help your resume in your next step.
By now the company’s date for filling this job is getting closer and you are one of a few surviving candidates. The Vice-President of the company is going to meet with all of the finalists and will recommend one to the company President and CEO. To increase the pressure on the finalists, each of them is interviewed as the others watch. The VP has to catch a plane so every extra minute the other candidates take making themselves more impressive means you have less time before the VP leaves to catch the plane. Five minutes before she has to grab her briefcase and bolt out the door, she turns to you. You have only five minutes to sum up everything that justifies your application and your abilities. Five minutes to prove you deserve to be the one who walks into the office of the President and stands at his desk as the newest important employee of the company.
Today is that five minutes for the Missouri legislature.
Today is the last chance for hundreds of bills to make a good enough impression to be sent to the the Governor’s desk, potentially as the newest important laws for Missouri. It’s the last five minutes of the long process and all of the company VPs go out the door at 6 p.m.
. . . . and the applicant’s name is . . wait for it . . . “Bill”.


Amateur astronomers never know what signals they might pick up.
A satellite lost 13 years ago was just, briefly, found. Now a group of optimistic technicians may have a chance to bring it back into the fold. In January, amateur astronomer Scott Tilley of British Columbia sat in his home, scanning radio frequencies for the U.S. Air Force satellite lost after a January 7 SpaceX launch. Tilley indeed found a lost satellite, but not the one he intended. Using a satellite catalog, he looked up its transmitter frequency and spin rate, and realized he had to alert NASA.
Back in 2005, the space agency suddenly lost contact with IMAGE, the Imager for Magnetopause-to-Aurora Global Exploration, a solar wind observer. Launched in 2000, the mission was already three years past its expected duration. Still, the team decided to try contacting it again two years later, when a 2007 eclipse cutting off the satellite’s solar-powered systems would force a reboot. But IMAGE stayed silent, and NASA declared the spacecraft lost.
Richard Burley, former IMAGE mission director, isn’t sure how the spacecraft came online, but suspects a flaw in the power system, which the team encountered in 2004, could have been triggered again, restarting the computer and putting it into a 72-hour reboot cycle. “We cannot tell exactly how long it has been in this mode,” says Burley, but amateur astronomers have looked back at their data and found IMAGE’s signal as far back as October 2016.
Then on February 25, IMAGE went worryingly quiet again—but not in the same manner it did in 2005, says Burley. He suspects there’s an issue with IMAGE’s spin axis in relation to its medium-gain antenna placement. If NASA can regain control of the spacecraft, it will decide if it can fund a mission restart.
The quixotic tale of a wayward satellite could have a happy ending yet.


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In Truckee California 96160, all Medicare supplement standardized plans are offered to qualified individuals under the age of 65 and/or to Medicare-qualified individuals due to disability or end-stage renal disease. In some states, a limited selection of Medicare supplement standardized plans is available to such individuals.
Medicare.gov provides tools that will allow you to compare plans in Truckee CA 96160 Nevada county, but the decision is complicated. Insurance agent Graves recommends that you “work with a licensed insurance agent who can show you both Medicare Supplement Plans and Advantage Plans from multiple companies. Each type has its positives.” The questions to cover, he says: “You need to understand the costs, doctor networks, coverage levels and maximum out-of-pocket for each. Enroll in what suits your situation best.” Organizations such as Consumer Reports and the Medicare Rights Center can also help you research your decision.


This cat mom decal has kitty paw prints with claws. The size is 8" by 8".
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by Tom Cox MRPharmS, Lead Prison Pharmacist.
It’s long been recognised within prison populations that there’s a high prevalence of substance use disorder in connection with prescription medicines. This is often found alongside problematic polypharmacy situations.[i] My main objective as a Lead Prison Pharmacist is to optimise medicines and resolve problematic polypharmacy, to try and rehabilitate people held in custody.
Medicines optimisation within a prison takes many forms, just as it does in other areas of health care. It starts with comprehensive medicines reconciliation when people arrive at the prison. Compared with the general population, people in custody have often lived chaotic lifestyles, either on the outside of prison, or perhaps in other prisons, so the first step is to understand what they have been taking, and how they have or have not been managing their medicines.
A particular problem we encounter during medicines reconciliation is that when a person arrives in prison, they often have other people’s prescription medicines in their possession, as well as their own. This forms important evidence for any resulting medicines optimisation.
Being a prison pharmacist has its own set of challenges but challenges tend to reap their own rewards. Most of the time I feel like I’m making a positive difference to the lives of some of the most vulnerable in society.
I work in a Category B prison holding 445 adult male prisoners with the majority being Welsh.


Annita Ray was born in Hudson Falls, New York, possibly in the mid-to-late 1930's. Her first public presence was seen and heard via the movie Shake, Rattle and Rock, filmed during the latter part of 1956. Soon following the movie's release in April 1957 came the release of her first single. After at least 3 more releases on just as many labels, in 1960 Annita hooked up with Ray Anthony and his Bookend Revue, along with Diane Hall. Before year's end 1961, Annita and Diane left the Revue and continued performing as a duo.
After a couple of years, the two women began touring on their own, performing throughout the United States and in many parts of the world, even spending two months in Vietnam in 1967. In the meantime, Annita continued recording on her own with two more singles and an album between the two. Eventually Annita and Diane began recording together for Wand Records as Diane And Annita.
The singer retired in 1970 and later went "full-bore" into commercial real estate. But her voice – the voice that once entertained thousands – started to quiver.
"I would be in high-powered meetings, and people thought I was nervous. But I knew what I was talking about and was completely confident," said Hirsch, who married attorney Ephraim Hirsch in 1976. In August 1984 she began a second career as a licensed Real Estate Broker.


Patrolling the treacherous waters of Lake Michigan, the dedicated U.S. Coast Guard personnel of Sector Lake Michigan perform their duties with renowned excellence and skill. This precision-struck coin captures the symbols and salutes the dedication of those “Brew-City Maritime Guardians” in a unique and enduring way.
The “Brew-City Maritime Guardians” are headquartered in Milwaukee, WI, or “Brew City,” so named for its renowned brewing industry. Sector Lake Michigan is the largest of all the Coast Guard Sectors in terms of units and the fourth largest in terms of personnel. The sector’s vital mission includes search and rescue, law enforcement, marine safety, aids to navigation and homeland security for all of Lake Michigan and its surrounding waterways.
The obverse features a rendering of the Sector Lake Michigan emblem. The reverse bears the official seal of the U.S. Coast Guard. Struck in a brass alloy, this coin is imbued with enamel on both sides.


Cosmetic dentistry uses Cosmetic dental bonding to improve smile in Chicago.
Chicago patient had spacing and very round shaped teeth that she felt made her look like a little kid. Dr. Jeffrey Weller placed 4 anterior front teeth cosmetic bonding restorations to improve this patient's smile and confidence. Tooth colored bonding that enhances the full facial aspect of the tooth made a huge difference closing spaces, and improving tooth shape.


5959 Staples, Suite 211, Corpus Christi, TX 78413.
Call the office for issues regarding HOA code compliance or health and welfare issues (not responsible for 911 emergency response calls).
Kings Crossing Security Officers: Paul Janko, Braden Tackett, Michael Munoz. Send security or safety concerns to these officers via our HOA Security Committee by filling out the Security/Safety Report Form on our Website. If you have a security issue that is not an emergency, please contact the CCPD non-emergency number listed below. If you have an actual security emergency, you should dial 911.
City of Corpus Christi Problem Reporting: use the phone number below to report issues regarding street problems/repair, safety concerns, utilities, animal care, code enforcement, solid waste or graffiti.
Click here for the City of Corpus Christi Website.
Click here to submit a service request to the City.


Patrick Gordon rose to prominence on the strength of his large, deeply saturated, somewhat eccentric still life and portraiture paintings, gaining a reputation as an important painter of the “New American Realism” school. Coinciding with a move to New York City in 2003, Patrick began working almost exclusively in oil-on-canvas, an early love, and a shift that represented and embodied a creative infusion of urban life and new beginnings. The artist now lives and works in Tulsa, OK.


My brow game is strong in 2016 and Lust Minerals has a fantastic product to help you create dramatic eyes. I love a mineral makeup brand too as it is fantastic for your skin and I cant wait to share it with one of you.
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Congratulations Hannah. Please email pr@mrstinkblog.com to claim your prize.


There are 1,307 movable 20ft container house suppliers, mainly located in Asia. The top supplying countries are China (Mainland), South Africa, and Saudi Arabia, which supply 99%, 1%, and 1% of movable 20ft container house respectively. Movable 20ft container house products are most popular in Domestic Market, South America, and Africa.
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Medically reviewed by Drugs.com. Last updated on Oct 1, 2018.
Dalvance® (dalbavancin) for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI), caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus) and Enterococcus faecalis (vancomycin susceptible strains).
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Dalvance and other antibacterial agents, Dalvance should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
The recommended dosage regimen of Dalvance in patients with normal renal function is 1500 mg, administered either as a single dose, or 1000 mg followed one week later by 500 mg. Dalvance should be administered over 30 minutes by intravenous infusion [see Dosage and Administration (2.3)].
In patients with renal impairment whose known creatinine clearance is less than 30 mL/min and who are not receiving regularly scheduled hemodialysis, the recommended regimen of Dalvance is 1125 mg, administered as a single dose, or 750 mg followed one week later by 375 mg (see Table 1). No dosage adjustment is recommended for patients receiving regularly scheduled hemodialysis, and Dalvance can be administered without regard to the timing of hemodialysis [see Use in Specific Populations (8.5), Clinical Pharmacology (12.3)].
Dalvance (dalbavancin) for injection must be reconstituted with either Sterile Water for Injection, USP, or 5% Dextrose Injection, USP, and subsequently diluted only with 5% Dextrose Injection, USP, to a final concentration of 1 mg/mL to 5 mg/mL.
Reconstitution: Dalvance must be reconstituted under aseptic conditions, using 25 mL of either Sterile Water for Injection, USP, or 5% Dextrose Injection, USP, for each 500 mg vial. To avoid foaming, alternate between gentle swirling and inversion of the vial until its contents are completely dissolved. Do not shake. The reconstituted vial contains 20 mg/mL dalbavancin as a clear, colorless to yellow solution.
Reconstituted vials may be stored either refrigerated at 2 to 8 °C (36 to 46 °F), or at controlled room temperature 20 to 25 °C (68 to 77 °F). Do not freeze.
Dilution: Aseptically transfer the required dose of reconstituted dalbavancin solution from the vial(s) to an intravenous bag or bottle containing 5% Dextrose Injection, USP. The diluted solution must have a final dalbavancin concentration of 1 mg/mL to 5 mg/mL. Discard any unused portion of the reconstituted solution.
Once diluted into an intravenous bag or bottle as described above, Dalvance may be stored either refrigerated at 2 to 8 °C (36 to 46 °F) or at a controlled room temperature of 20 to 25 °C (68 to 77 °F). Do not freeze.
The total time from reconstitution to dilution to administration should not exceed 48 hours.
Like all parenteral drug products, diluted Dalvance should be inspected visually for particulate matter prior to infusion. If particulate matter is identified, do not use.
Administration: After reconstitution and dilution, Dalvance is to be administered via intravenous infusion, using a total infusion time of 30 minutes.
Do not co-infuse Dalvance with other medications or electrolytes. Saline-based infusion solutions may cause precipitation and should not be used. The compatibility of reconstituted Dalvance with intravenous medications, additives, or substances other than 5% Dextrose Injection, USP has not been established.
If a common intravenous line is being used to administer other drugs in addition to Dalvance, the line should be flushed before and after each Dalvance infusion with 5% Dextrose Injection, USP.
Dalvance is supplied in clear glass vials containing sterile powder (white/off-white to pale yellow) equivalent to 500 mg of dalbavancin.
Dalvance is contraindicated in patients with known hypersensitivity to dalbavancin. No data are available on cross-reactivity between dalbavancin and other glycopeptides, including vancomycin.
Serious hypersensitivity (anaphylactic) and skin reactions have been reported in patients treated with Dalvance. If an allergic reaction occurs, treatment with Dalvance should be discontinued. Before using Dalvance, inquire carefully about previous hypersensitivity reactions to glycopeptides, and due to the possibility of cross-sensitivity, exercise caution in patients with a history of glycopeptide allergy [see Patient Counseling Information (17)].
Dalvance is administered via intravenous infusion, using a total infusion time of 30 minutes to minimize the risk of infusion-related reactions. Rapid intravenous infusions of Dalvance can cause reactions that resemble “Red-Man Syndrome,” including flushing of the upper body, urticaria, pruritus, rash, and/or back pain. Stopping or slowing the infusion may result in cessation of these reactions.
In Phase 2 and 3 clinical trials, more Dalvance than comparator-treated subjects with normal baseline transaminase levels had post-baseline alanine aminotransferase (ALT) elevation greater than 3 times the upper limit of normal (ULN). Overall, abnormalities in liver tests (ALT, AST, bilirubin) were reported with similar frequency in the Dalvance and comparator arms [see Adverse Reactions (6.1)].
Clostridium difficile-associated diarrhea (CDAD) has been reported in users of nearly all systemic antibacterial drugs, including Dalvance, with severity ranging from mild diarrhea to fatal colitis. Treatment with antibacterial agents can alter the normal flora of the colon, and may permit overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antibacterial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile should be discontinued, if possible. Appropriate measures such as fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Prescribing Dalvance in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of Dalvance cannot be directly compared to rates in the clinical trials of another drug and may not reflect rates observed in practice.
Adverse reactions were evaluated for 2473 patients treated with Dalvance: 1778 patients were treated with Dalvance in seven Phase 2/3 trials comparing Dalvance to comparator antibacterial drugs and 695 patients were treated with Dalvance in one Phase 3 trial comparing Dalvance single and two-dose regimens. A causal relationship between study drug and adverse reactions was not always established. The median age of patients treated with Dalvance was 48 years, ranging between 16 and 93 years. Patients treated with Dalvance were predominantly male (59.5%) and White (81.2%).
Serious adverse reactions occurred in 121/2473 (4.9%) of patients treated with any regimen of Dalvance. In the Phase 2/3 trials comparing Dalvance to comparator, serious adverse reactions occurred in 109/1778 (6.1%) of patients in the Dalvance group and 80/1224 (6.5%) of patients in the comparator group. In a Phase 3 trial comparing Dalvance single and two-dose regimens, serious adverse reactions occurred in 7/349 (2.0%) of patients in the Dalvance single dose group and 5/346 (1.4%) of patients in the Dalvance two-dose group. Dalvance was discontinued due to an adverse reaction in 64/2473 (2.6%) patients treated with any regimen of Dalvance. In the Phase 2/3 trials comparing Dalvance to comparator, Dalvance was discontinued due to an adverse reaction in 53/1778 (3.0%) of patients in the Dalvance group and 35/1224 (2.9%) of patients in the comparator group. In a Phase 3 trial comparing Dalvance single and two-dose regimens, Dalvance was discontinued due to an adverse reaction in 6/349 (1.7%) of patients in the Dalvance single dose group and 5/346 (1.4%) of patients in the Dalvance two-dose group.
The most common adverse reactions in patients treated with Dalvance were nausea (4.7%), headache (3.8%), and diarrhea (3.4%). The median duration of adverse reactions was 3.0 days in patients treated with Dalvance. In the Phase 2/3 trials comparing Dalvance to comparator, the median duration of adverse reactions was 3.0 days for patients in the Dalvance group and 4.0 days in patients in the comparator group. In a Phase 3 trial comparing Dalvance single and two-dose regimens, the median duration of adverse reactions was 3.0 days for patients in the Dalvance single and two-dose group.
Table 2 lists selected adverse reactions occurring in 2% or more of patients treated with Dalvance in Phase 2/3 clinical trials.
* Comparators included linezolid, cefazolin, cephalexin, and vancomycin.
In the Phase 3 trial comparing the single and two-dose regimen of Dalvance, the adverse reaction that occurred in 2% or more of patients treated with Dalvance was nausea (3.4% in the Dalvance single dose group and 2% in the Dalvance two-dose group).
Among patients with normal baseline ALT levels treated with Dalvance 17 (0.8%) had post-baseline ALT elevations greater than 3 times the upper limit of normal (ULN) including five subjects with post-baseline ALT values greater than 10 times ULN. Among patients with normal baseline ALT levels treated with non-Dalvance comparators 2 (0.2%) had post-baseline ALT elevations greater than 3 times the upper limit of normal. Fifteen of the 17 patients treated with Dalvance and one comparator patient had underlying conditions which could affect liver enzymes, including chronic viral hepatitis, history of alcohol abuse and metabolic syndrome. In addition, one Dalvance-treated subject in a Phase 1 trial had post-baseline ALT elevations greater than 20 times ULN. ALT elevations were reversible in all subjects with follow-up assessments. No comparator-treated subject with normal baseline transaminases had post-baseline ALT elevation greater than 10 times ULN.
The following adverse reaction has been identified during post-approval use of dalbavancin. Because the reaction is reported voluntarily from a population of uncertain size, it is not possible to reliably estimate the frequency or establish a causal relationship to drug exposure.
General disorders and administration site conditions: Back pain as an infusion-related reaction [See Warnings and Precautions (5.2)].
Drug-laboratory test interactions have not been reported. Dalvance at therapeutic concentrations does not artificially prolong prothrombin time (PT) or activated partial thromboplastin time (aPTT).
No clinical drug-drug interaction studies have been conducted with Dalvance. There is minimal potential for drug-drug interactions between Dalvance and cytochrome P450 (CYP450) substrates, inhibitors, or inducers [see Clinical Pharmacology (12.3)].
There have been no adequate and well-controlled studies with Dalvance in pregnant women. Dalvance should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
No treatment-related malformations or embryo-fetal toxicity were observed in pregnant rats or rabbits at clinically relevant exposures of dalbavancin. Treatment of pregnant rats with dalbavancin at 3.5 times the human dose on an exposure basis during early embryonic development and from implantation to the end of lactation resulted in delayed fetal maturation and increased fetal loss, respectively [see Data].
The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies.
No evidence of embryo or fetal toxicity was found in the rat or rabbit at a dose of 15 mg/kg/day (1.2 and 0.7 times the human dose on an exposure basis, respectively). Delayed fetal maturation was observed in the rat at a dose of 45 mg/kg/day (3.5 times the human dose on an exposure basis).
In a rat prenatal and postnatal development study, increased embryo lethality and increased offspring deaths during the first week post-partum were observed at a dose of 45 mg/kg/day (3.5 times the human dose on an exposure basis).
It is not known whether dalbavancin or its metabolite is excreted in human milk; therefore, caution should be exercised when Dalvance is administered to a nursing woman.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Dalvance and any potential adverse effects on the breastfed child from Dalvance or from the underlying maternal condition.
Dalbavancin is excreted in the milk of lactating rats.
Safety and efficacy in pediatric patients have not been established.
Of the 2473 patients treated with Dalvance in Phase 2 and 3 clinical trials, 403 patients (16.3%) were 65 years of age or older. The efficacy and tolerability of Dalvance were similar to comparator regardless of age. The pharmacokinetics of Dalvance was not significantly altered with age; therefore, no dosage adjustment is necessary based on age alone.
Dalvance is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in this age group.
In patients with renal impairment whose known creatinine clearance is less than 30 mL/min and who are not receiving regularly scheduled hemodialysis, the recommended regimen for Dalvance is 1125 mg, administered as a single dose, or 750 mg followed one week later by 375 mg. No dosage adjustment is recommended for patients receiving regularly scheduled hemodialysis, and Dalvance can be administered without regard to the timing of hemodialysis [see Dosage and Administration (2.2), Clinical Pharmacology (12.3)].
No dosage adjustment of Dalvance is recommended for patients with mild hepatic impairment (Child-Pugh Class A). Caution should be exercised when prescribing Dalvance to patients with moderate or severe hepatic impairment (Child-Pugh Class B or C) as no data are available to determine the appropriate dosing in these patients [see Clinical Pharmacology (12.3)].
Specific information is not available on the treatment of overdose with Dalvance, as dose-limiting toxicity has not been observed in clinical studies. In Phase 1 studies, healthy volunteers have been administered cumulative doses of up to 4500 mg over a period of up to 8 weeks, with no signs of toxicity or laboratory results of clinical concern.
Treatment of overdose with Dalvance should consist of observation and general supportive measures. Although no information is available specifically regarding the use of hemodialysis to treat overdose, in a Phase 1 study in patients with renal impairment less than 6% of the recommended dalbavancin dose was removed [see Clinical Pharmacology (12.3)].
Dalvance (dalbavancin) for injection is a lipoglycopeptide synthesized from a fermentation product of Nonomuraea species.
Dalbavancin is a mixture of five closely related active homologs (A0, A1, B0, B1, and B2); the component B0 is the major component of dalbavancin. The homologs share the same core structure and differ in the fatty acid side chain of the N-acylaminoglucuronic acid moiety (R1) structure and/or the presence of an additional methyl group (R2) on the terminal amino group (shown in the Figure 1 and Table 3 below).
The B0 INN chemical name is: 5,31-dichloro-38-de(methoxycarbonyl)-7-demethyl-19-deoxy-56-O-[2-deoxy-2-[(10-methylundecanoyl)amino]-β-D-glucopyranuronosyl]-38-[[3-(dimethylamino)propyl] carbamoyl]-42-O-α-D-mannopyranosyl-15-N-methyl(ristomycin A aglycone) hydrochloride.
Dalvance is supplied in clear glass vials as a sterile, lyophilized, preservative-free, white to off-white to pale yellow solid. Each vial contains dalbavancin HCl equivalent to 500 mg of dalbavancin as the free base, plus lactose monohydrate (129 mg) and mannitol (129 mg) as excipients. Sodium hydroxide or hydrochloric acid may be added to adjust the pH at the time of manufacture. The powder is to be reconstituted and further diluted for IV infusion [see Dosage and Administration (2.3), How Supplied/Storage and Handling (16)].
Dalbavancin is an antibacterial drug [see Microbiology (12.4)].
The antibacterial activity of dalbavancin appears to best correlate with the ratio of area under the concentration-time curve to minimal inhibitory concentration (AUC/MIC) for Staphylococcus aureus based on animal models of infection. An exposure-response analysis of a single study in patients with complicated skin and skin structure infections supports the two-dose regimen [see Dosage and Administration (2.1), Clinical Pharmacology (12.3)].
Cardiac Electrophysiology: In a randomized, positive- and placebo-controlled, thorough QT/QTc study, 200 healthy subjects received dalbavancin 1000 mg IV, dalbavancin 1500 mg IV, oral moxifloxacin 400 mg, or placebo. Neither dalbavancin 1000 mg nor dalbavancin 1500 mg had any clinically relevant adverse effect on cardiac repolarization.
Dalbavancin pharmacokinetic parameters have been characterized in healthy subjects, patients, and specific populations. Pharmacokinetic parameters following administration of single intravenous 1000 mg and 1500 mg doses were as shown in Table 4. The pharmacokinetics of dalbavancin can be described using a three-compartment model.
1 Data from 50 healthy subjects.
2 Data from 12 healthy subjects.
3 Based upon population pharmacokinetic analyses of data from patients, the effective half-life is approximately 8.5 days (204 hours).
4 Data from 49 healthy subjects.
In healthy subjects, dalbavancin AUC0-24h and Cmax both increased proportionally to dose following single IV dalbavancin doses ranging from 140 mg to 1500 mg, indicating linear pharmacokinetics.
The mean plasma concentration-time profile for dalbavancin following the recommended two-dose regimen of 1000 mg followed one week later by 500 mg is shown in Figure 2.
Figure 2. Mean (± standard deviation) dalbavancin plasma concentrations versus time in healthy subjects (n=10) following IV administration over 30 minutes of 1000 mg dalbavancin (Day 1) and 500 mg dalbavancin (Day 8).
No apparent accumulation of dalbavancin was observed following multiple IV infusions administered once weekly for up to eight weeks, with 1000 mg on Day 1 followed by up to seven weekly 500 mg doses, in healthy adults with normal renal function.
Distribution: Dalbavancin is reversibly bound to human plasma proteins, primarily to albumin. The plasma protein binding of dalbavancin is approximately 93% and is not altered as a function of drug concentration, renal impairment, or hepatic impairment. The mean concentrations of dalbavancin achieved in skin blister fluid remain above 30 mg/L up to 7 days (approximately 146 hours) post dose, following 1000 mg IV dalbavancin. The mean ratio of the AUC0-144 hrs in skin blister fluid/AUC0-144 hrs in plasma is 0.60 (range 0.44 to 0.64).
Metabolism: In vitro studies using human microsomal enzymes and hepatocytes indicate that dalbavancin is not a substrate, inhibitor, or inducer of CYP450 isoenzymes. A minor metabolite of dalbavancin (hydroxy-dalbavancin) has been observed in the urine of healthy subjects. Quantifiable concentrations of the hydroxy-dalbavancin metabolite have not been observed in human plasma (lower limit of quantitation = 0.4 µg/mL) [see Drug Interactions (7.2)].
Excretion: Following administration of a single 1000 mg dose in healthy subjects, 20% of the dose was excreted in feces through 70 days post dose. An average of 33% of the administered dalbavancin dose was excreted in urine as unchanged dalbavancin and approximately 12% of the administered dose was excreted in urine as the metabolite hydroxy-dalbavancin through 42 days post dose.
Renal Impairment: The pharmacokinetics of dalbavancin were evaluated in 28 subjects with varying degrees of renal impairment and in 15 matched control subjects with normal renal function.
Following a single dose of 500 mg or 1000 mg dalbavancin, the mean plasma clearance (CLT) was reduced 11%, 35%, and 47% in subjects with mild (CLCR 50 to 79 mL/min), moderate (CLCR 30 to 49 mL/min), and severe (CLCR less than 30 mL/min), renal impairment, respectively, compared to subjects with normal renal function. The clinical significance of the decrease in mean plasma CLT, and the associated increase in AUC0-∞ noted in these pharmacokinetic studies of dalbavancin in subjects with severe renal impairment has not been established [see Dosage and Administration (2.2), Use in Specific Populations (8.6)].
No dosage adjustment is necessary for patients with CLCR greater than 30 mL/min or patients receiving hemodialysis. The recommended regimen for dalbavancin in patients with severe renal impairment who are not receiving regularly scheduled hemodialysis is 1125 mg, administered as a single dose, or 750 mg followed one week later by 375 mg.
Dalbavancin pharmacokinetic parameters in subjects with end-stage renal disease receiving regularly scheduled hemodialysis (three times/week) are similar to those observed in subjects with mild to moderate renal impairment, and less than 6% of an administered dose is removed after three hours of hemodialysis.
Therefore, no dosage adjustment is recommended for patients receiving regularly scheduled hemodialysis, and dalbavancin may be administered without regard to the timing of hemodialysis in such patients [see Dosage and Administration (2.1), Overdosage (10)].
Hepatic Impairment: The pharmacokinetics of dalbavancin were evaluated in 17 subjects with mild, moderate, or severe hepatic impairment (Child-Pugh class A, B or C) and compared to those in nine matched healthy subjects with normal hepatic function. The mean AUC0-336 hrs was unchanged in subjects with mild hepatic impairment compared to subjects with normal hepatic function; however, the mean AUC0-336 hrs decreased 28% and 31% in subjects with moderate and severe hepatic impairment respectively, compared to subjects with normal hepatic function. The clinical significance of the decreased AUC0-336 hrs in subjects with moderate and severe hepatic function is unknown.
No dosage adjustment is recommended for patients with mild hepatic impairment. Caution should be exercised when prescribing dalbavancin to patients with moderate or severe hepatic impairment as no data are available to determine the appropriate dosing.
Gender: Clinically significant gender-related differences in dalbavancin pharmacokinetics have not been observed either in healthy subjects or in patients with infections. No dosage adjustment is recommended based on gender.
Geriatric Patients: Clinically significant age-related differences in dalbavancin pharmacokinetics have not been observed in patients with infections. No dosage adjustment is recommended based solely on age.
Pediatric Patients: The pharmacokinetics of dalbavancin in pediatric populations <12 years of age have not been established.
Nonclinical studies demonstrated that dalbavancin is not a substrate, inhibitor, or inducer of CYP450 isoenzymes. In a population pharmacokinetic analysis, dalbavancin pharmacokinetics were not affected by co-administration with known CYP450 substrates, inducers or inhibitors, nor by individual medications including acetaminophen, aztreonam, fentanyl, metronidazole, furosemide, proton pump inhibitors (omeprazole, esomeprazole, pantoprazole, lansoprazole), midazolam, and simvastatin.
Dalbavancin, a semisynthetic lipoglycopeptide, interferes with cell wall synthesis by binding to the D-alanyl-D-alanine terminus of the stem pentapeptide in nascent cell wall peptidoglycan, thus preventing cross-linking. Dalbavancin is bactericidal in vitro against Staphylococcus aureus and Streptococcus pyogenes at concentrations similar to those sustained throughout treatment in humans treated according to the recommended dosage regimen.
The development of bacterial isolates resistant to dalbavancin has not been observed, either in vitro, in studies using serial passage, or in animal infection experiments.
When tested in vitro, dalbavancin demonstrated synergistic interactions with oxacillin and did not demonstrate antagonistic or synergistic interactions with any of the following antibacterial agents of various classes: gentamicin, vancomycin, levofloxacin, clindamycin, quinupristin/dalfopristin, linezolid, aztreonam, rifampin or daptomycin. The clinical significance of these in vitro findings is unknown.
Dalbavancin has been shown to be active against the following microorganisms, both in vitro and in clinical infections [see Indications and Usage (1)].
The following in vitro data are available, but their clinical significance is unknown. In addition, at least 90% of organisms in the following bacteria exhibit an in vitro minimum inhibitory concentration (MIC) less than or equal to the dalbavancin susceptible breakpoint of 0.25 mcg/mL. However, the safety and efficacy of dalbavancin in treating clinical infections due to these bacteria have not been established in adequate well-controlled clinical trials.
Long-term studies in animals to determine the carcinogenic potential of dalbavancin have not been conducted.
Dalbavancin was not genotoxic in a bacterial reverse mutation (Ames) assay, a mammalian HGPRT gene mutation assay, an in vitro chromosome aberration assay in Chinese Hamster Ovary cells, or an in vivo mouse micronucleus assay.
Impaired fertility in the rat was not observed at a dose of 15 mg/kg/day (1.2 times the human dose on an exposure basis). Reductions in male and female fertility and increased embryo resorptions occurred at a dose of 45 mg/kg/day (3.5 times the human dose on an exposure basis), at which signs of parental toxicity were also observed.
Increases in serum levels of liver enzymes (ALT, AST), associated with microscopic findings in the liver were noted in toxicology studies in rats and dogs where dalbavancin was administered daily for 28 to 90 days. Hepatocellular necrosis was observed in dogs dosed at ≥10 mg/kg/day for longer than 2 months, i.e., at approximately 5 to 7 times the expected human dose on an exposure basis. Histiocytic vacuolation and hepatocyte necrosis were observed in rats dosed daily at 40 and 80 mg/kg/day, respectively, for 4 weeks, (approximately 3 and 6 times the expected human dose on an exposure basis, respectively). In addition, renal toxicity characterized by increases in serum BUN and creatinine and microscopic kidney findings was observed in rats and dogs at doses 5 to 7 times the expected human dose on an exposure basis. The relationship between these findings in the animal toxicology studies after 28 and 90 consecutive days of dosing to the indicated clinical dosing of 2 doses 7 days apart are unclear.
Adult patients with ABSSSI were enrolled in two Phase 3, randomized, double-blind, double-dummy clinical trials of similar design (Trial 1 and Trial 2). The Intent-to-Treat (ITT) population included 1,312 randomized patients. Patients were treated for two weeks with either a two-dose regimen of intravenous Dalvance (1000 mg followed one week later by 500 mg) or intravenous vancomycin (1000 mg or 15 mg/kg every 12 hours, with the option to switch to oral linezolid after 3 days). Dalvance-treated patients with creatinine clearance of less than 30 mL/min received 750 mg followed one week later by 375 mg. Approximately 5% of patients also received a protocol-specified empiric course of treatment with intravenous aztreonam for coverage of Gram-negative pathogens.
The specific infections in these trials included cellulitis (approximately 50% of patients across treatment groups), major abscess (approximately 30%), and wound infection (approximately 20%). The median lesion area at baseline was 341 cm2. In addition to local signs and symptoms of infection, patients were also required to have at least one systemic sign of disease at baseline, defined as temperature 38°C or higher (approximately 85% of patients), white blood cell count greater than 12,000 cells/mm3 (approximately 40%), or 10% or more band forms on white blood cell differential (approximately 23%). Across both trials, 59% of patients were from Eastern Europe and 36% of patients were from North America. Approximately 89% of patients were Caucasian and 58% were males. The mean age was 50 years and the mean body mass index was 29.1 kg/m2.
The primary endpoint of these two ABSSSI trials was the clinical response rate where responders were defined as patients who had no increase from baseline in lesion area 48 to 72 hours after initiation of therapy, and had a temperature consistently at or below 37.6° C upon repeated measurement. Table 5 summarizes overall clinical response rates in these two ABSSSI trials using the pre-specified primary efficacy endpoint in the ITT population.
1 There were 7 patients who did not receive treatment and were counted as non-responders: 6 Dalvance patients (3 in each trial) and one vancomycin/linezolid patient in Trial 2.
2 Patients who died or used non-study antibacterial therapy or had missing measurements were classified as non-responders.
3 The 95% Confidence Interval (CI) is computed using the Miettinen and Nurminen approach, stratified by baseline fever status.
A key secondary endpoint in these two ABSSSI trials evaluated the percentage of ITT patients achieving a 20% or greater reduction in lesion area from baseline at 48-72 hours after initiation of therapy. Table 6 summarizes the findings for this endpoint in these two ABSSSI trials.
1 There were 7 patients (as described in Table 5) who did not receive treatment and were counted as non-responders.
3 The 95% CI is computed using the Miettinen and Nurminen approach, stratified by baseline fever status.
Another secondary endpoint in these two ABSSSI trials was the clinical success rate assessed at a follow-up visit occurring between Days 26 to 30. Clinical Success at this visit was defined as having a decrease in lesion size (both length and width measurements), a temperature of 37.6° C or lower, and meeting pre-specified criteria for local signs: purulent discharge and drainage absent or mild and improved from baseline, heat/warmth & fluctuance absent, swelling/induration & tenderness to palpation absent or mild.
Table 7 summarizes clinical success rates at a follow-up visit for the ITT and clinically evaluable population in these two ABSSSI trials. Note that there are insufficient historical data to establish the magnitude of drug effect for antibacterial drugs compared with placebo at the follow-up visits. Therefore, comparisons of Dalvance to vancomycin/linezolid based on clinical success rates at these visits cannot be utilized to establish non-inferiority.
1 There were 7 patients (as described in Table 5) who did not receive treatment and were counted as failures in the analysis.
2 Patients who died, used non-study antibacterial therapy, or had an unplanned surgical intervention 72 hours after the start of therapy were classified as Clinical Failures.
Table 8 shows outcomes in patients with an identified baseline pathogen, using pooled data from Trials 1 and 2 in the microbiological ITT (microITT) population. The outcomes shown in the table are clinical response rates at 48 to 72 hours and clinical success rates at follow-up (Day 26 to 30), as defined above.
All Dalvance dosing regimens in Trials 1 and 2 consisted of two doses.
1 There were 2 patients in the Dalvance arm with methicillin-susceptible S. aureus at baseline who did not receive treatment and were counted as non-responders/failures.
2 Early Responders are patients who had no increase from baseline in lesion area 48 to 72 hours after initiation of therapy, and had a temperature consistently at or below 37.6° C upon repeated measurement.
Adult patients with ABSSSI were enrolled in a Phase 3, double-blind, clinical trial. The ITT population included 698 patients who were randomized to Dalvance treatment with either a single 1500 mg dose or a two-dose regimen of 1000 mg followed one week later by 500 mg (Trial 3). Patients with creatinine clearance less than 30 mL/min had their dose adjusted (Section 2.2). Approximately 5% of patients also received a protocol-specified empiric course of treatment with intravenous aztreonam for coverage of Gram-negative pathogens. The specific infections and other patient characteristics in this trial were similar to those described above for previous ABSSSI trials.
The primary endpoint in this ABSSSI trial was the clinical response rate where responders were defined as patients who had at least a 20% decrease from baseline in lesion area 48 to 72 hours after randomization without receiving any rescue antibacterial therapy. The secondary endpoint was the clinical success rate at a follow-up visit occurring between Days 26 and 30, with clinical success defined as having at least a 90% decrease from baseline in lesion size, a temperature of 37.6° C or lower, and meeting pre-specified criteria for local signs: purulent discharge and drainage absent or mild and improved from baseline (for patients with wound infections), heat/warmth and fluctuance absent, swelling/induration and tenderness to palpation absent or mild. Table 9 summarizes results for these two endpoints in the ITT population. Note that there are insufficient historical data to establish the magnitude of drug effect for antibacterial drugs compared with placebo at the follow-up visit. Therefore, comparisons between treatment groups based on clinical success rates at this visitcannot be utilized to establish non-inferiority.
1 There were 3 patients in the two-dose group who did not receive treatment and were counted as non-responders.
3 The 95% Confidence Interval (CI) is computed using the Miettinen and Nurminen approach.
Table 10 shows outcomes in patients with an identified baseline pathogen from Trial 3 in the microbiological ITT (microITT) population. The outcomes shown in the table are clinical response rates at 48 to 72 hours and clinical success rates at follow-up (Day 26 to 30), as defined above.
In Trials 1, 2, and 3, all patients had blood cultures obtained at baseline. A total of 40 ABSSSI patients who received Dalvance had bacteremia at baseline caused by one or more of the following bacteria: 26 S. aureus (21 MSSA and 5 MRSA), 6 S. agalactiae, 7 S. pyogenes, 2 S. anginosus group, and 1 E. faecalis. In patients who received Dalvance, a total of 34/40 (85%) were clinical responders at 48-72 hours and 32/40 (80%) were clinical successes at Day 26 to 30.
Unreconstituted Dalvance (dalbavancin) for injection should be stored at 25ºC (77ºF); excursions permitted to 15 to 30ºC (59 to 86ºF) [see USP Controlled Room Temperature].
Patients should be advised that allergic reactions, including serious allergic reactions, could occur, and that serious allergic reactions require immediate treatment. Patients should inform their healthcare provider about any previous hypersensitivity reactions to Dalvance, or other glycopeptides.
Patients should be counseled that antibacterial drugs including Dalvance should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Dalvance is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Dalvance and other antibacterial drugs in the future.
Patients should be advised that diarrhea is a common problem caused by antibacterial drugs and usually resolves when the drug is discontinued. Sometimes, frequent watery or bloody diarrhea may occur and may be a sign of a more serious intestinal infection. If severe watery or bloody diarrhea develops, patients should contact their healthcare provider.
Dalvance® is a registered trademark of Durata Therapeutics Holding C.V., an Allergan affiliate.
© 2018 Allergan. All rights reserved.


We just finished our second eight-week session of ballet at the local community center.
...and their baby brother too.
Someone sure does love his new big boy bed.
His sisters think it's pretty cool too.
Lots of growin' up going on around here.
Lots of mixed emotions too.
What's not to love about chocolate chip pancakes?
And what not to love about that face?


Will the No No Hair Removal System Work for you?
When people see a new hair removal system that they have not tried, one of the first things they usually wonder is if the system will work for them. The No No Hair Removal system is one of these systems, as so many people use it and say it works for them.
Will the No No Hair Removal system work for you, or will you be one of the few people that does not see results?
What color is your hair? -- If you have darker hair that is coarse or thick, you will notice the No No Hair Removal system will work quickly for you. If you have lighter hair, it will take a little more time to work and, if you have blonde hair, it will not work at all. Be sure the type of hair you have is the hair that the manufacturer says the NoNo Hair Removal system works on before you buy it.
Can you commit to daily use? -- Another reason for the No No Hair Removal system working or not working is the amount of commitment you are able to give to using the product.
This means it will generally work for you, just like it works for almost everyone else, if you are willing to commit to using it. That means, while you only have to use it for five to 10 minutes every day, you do have to use it every day for at least the first few weeks.
Long-term use -- The people who say the No No Hair Removal system does not work are usually the ones that do not commit to using it. This is because you will need to use the No No Hair Removal system for several months if you want to get the results promised by the manufacturer.


There are all sorts of things I learn that don’t have a category. This is where I stuff them. Hopefully they start to form groups over time… but hey, maybe not.


Most people are familiar with the sudden pain of a muscle cramp. The rapid, uncontrolled contraction, or spasm, happens unexpectedly, with either no stimulation or some trivially small one.
The muscle contraction and pain lasts for several minutes, and then slowly eases. Cramps may affect any muscle, but are most common in the calves, feet, and hands. While painful, they are harmless, and in most cases, not related to any underlying disorder. Nonetheless, cramps and spasms can be manifestations of many neurological or muscular diseases.
The terms cramp and spasm can be somewhat vague, and they are sometimes used to include types of abnormal muscle activity other than sudden painful contraction. These include stiffness at rest, slow muscle relaxation, and spontaneous contractions of a muscle at rest (fasciculation). Fasciculation is a type of painless muscle spasm, marked by rapid, uncoordinated contraction of many small muscle fibers. A critical part of diagnosis is to distinguish these different meanings and to allow the patient to describe the problem as precisely as possible.
Normal voluntary muscle contraction begins when electrical signals are sent from the brain through the spinal cord along nerve cells called motor neurons (Nerve cells within the central nervous system that carry nerve impulses controlling muscle movement). These include both the upper motor neurons within the brain and the lower motor neurons (nerve cells within the central nervous system that carry nerve impulses controlling muscle movement) within the spinal cord and leading out to the muscle. At the muscle, chemicals released by the motor neuron stimulate the internal release of calcium ions from stores within the muscle cell. These calcium ions then interact with muscle proteins within the cell, causing the proteins (actin and myosin) to slide past one another. This motion pulls their fixed ends closer, thereby shortening the cell and, ultimately, the muscle itself. Recapture of calcium and unlinking of actin and myosin allows the muscle fiber to relax.
Abnormal contraction may be caused by abnormal activity at any stage in this process. Certain mechanisms within the brain and the rest of the central nervous system help regulate contraction. Interruption of these mechanisms can cause spasm. Motor neurons that are overly sensitive may fire below their normal thresholds. The muscle membrane itself may be over sensitive, causing contraction without stimulation. Calcium ions may not be recaptured quickly enough, causing prolonged contraction.
Interuption of brain mechanisms and overly sensitive motor neurons may result from damage to the nerve pathways. Possible causes include stroke, multiple sclerosis, cerebral palsy, neurodegenerative diseases, trauma, spinal cord injury, and nervous system poisons such as strychnine, tetanus, and certain insecticides. Nerve damage may lead to a prolonged or permanent muscle shortening called contracture.
Prolonged exercise: Curiously, relaxation of a muscle actually requires energy to be expended. The energy is used to recapture calcium and to unlink actin and myosin. Normally, sensations of pain and fatigue signal that it is time to rest. Ignoring or overriding those warning signals can lead to such severe energy depletion that the muscle cannot be relaxed, causing a cramp. The familiar advice about not swimming after a heavy meal, when blood flow is directed away from the muscles, is intended to avoid this type of cramp. Rigor mortis, the stiffness of a corpse within the first 24 hours after death, is also due to this phenomenon.
Dehydration and Salt Depletion: This may be brought on by protracted vomiting or diarrhea, or by copious sweating during prolonged exercise, especially in high temperatures. Loss of fluids and salts--especially sodium, potassium, magnesium, and calcium--can disrupt ion balances in both muscle and nerves. This can prevent them from responding and recovering normally, and can lead to cramp.
Metabolic disorders that affect the energy supply in muscle. These are inherited diseases in which particular muscle enzymes are deficient. They include deficiencies of myophosphorylase (McArdle's disease), phosphorylase b kinase, phosphofructokinase, phosphoglycerate kinase, and lactate dehydrogenase.
Myotonia: This causes stiffness due to delayed relaxation of the muscle, but does not cause the spontaneous contraction usually associated with cramps. However, many patients with myotonia do experience cramping from exercise. Symptoms of myotonia are often worse in the cold. Myotonias include myotonic dystrophy, myotonia congenita, paramyotonia congenita, and neuromyotonia.
The pain of a muscle cramp is intense, localized, and often debilitating Coming on quickly, it may last for minutes and fade gradually. Contractures develop more slowly, over days or weeks, and may be permanent if untreated. Fasciculations may occur at rest or after muscle contraction, and may last several minutes.
Most cases of simple cramps require no treatment other than patience and stretching. Gently and gradually stretching and massaging the affected muscle may ease the pain and hasten recovery.
More prolonged or regular cramps may be treated with drugs such as carbamazepine, phenytoin, or quinine. Fluid and salt replacement, either orally or intravenously, is used to treat dehydration. Treatment of underlying metabolic or neurologic disease, where possible, may help relieve symptoms.
Cramps may be treated or prevented with Gingko (Ginkgo biloba) or Japanese quince (Chaenomeles speciosa). Supplements of vitamin E, niacin, calcium, and magnesium may also help. Taken at bedtime, they may help to reduce the likelihood of night cramps.
The likelihood of developing cramps may be reduced by eating a healthy diet with appropriate levels of minerals, and getting regular exercise to build up energy reserves in muscle. Avoiding exercising in extreme heat helps prevent heat cramps. Heat cramps can also be avoided by taking salt tablets and water before prolonged exercise in extreme heat. Taking a warm bath before bedtime may increase circulation to the legs and reduce the incidence of night-time leg cramps.