Posts Tagged ‘flu’

Peramivir Emergency Use Authorized by FDA

The U.S. Food and Drug Administration has announced recently that in response to a request from the U.S. Centers for Disease Control (CDC) and Prevention, it has issued an emergency use authorization or EUA for the investigational antiviral drug peramivir intravenous (IV) in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital. The CDC has developed an electronic request system that lets healthcare providers request peramivir for patients who have been admitted to their hospitals due to 2009 H1N1 influenza.

More explicitly, IV peramivir is authorized only for hospitalized adult and pediatric patients for whom therapy with an IV drug is clinically suitable, based on one or more of the following reasons.  The first is if the patient is not responding to either oral or inhaled antiviral therapy, or when drug delivery by a route other than an intravenous route like enteral which is absorbed by the intestines or inhaled is not expected to be dependable or feasible.  The other is for adults only, when the health care professional deems IV therapy is appropriate due to other circumstances and t he FDA has reviewed the available scientific data and has concluded that the criteria for authorizing the emergency use of IV peramivir have been met.

There are no FDA-approved intravenously administered antivirals for the treatment of influenza. Peramivir is the only intravenously administered influenza treatment currently authorized for use under EUA for 2009 H1N1 infections. The EUA authority allows the FDA, based on the evaluation of available data, to authorize the use of unapproved or un-cleared medical products or unapproved or un-cleared uses of approved or cleared medical products following a determination and declaration of emergency, provided certain criteria are met. The authorization will end when the declaration of emergency is terminated or the authorization is revoked by the agency.

It has been reported that by the end of July, up to 5.7 million Americans which is 140 times the reported number had H1N1 swine flu.  As many as 21,000 flu sufferers were hospitalized by July 23, according to CDC estimates. This suggests that the current number of H1N1 swine flu-related hospitalizations is a vast underestimate. The number is just under 22,000 from the end of August to the middle of October.

When reporting numbers of hospitalizations and deaths, CDC officials have always noted that the data is just a guide to the severity of the pandemic and not a precise tally.  We still don’t really know exactly how many millions of Americans have come down with H1N1 swine flu.  That question is still unanswered, but there’s been more than a fivefold increase in increasing flu-related hospitalizations and deaths since Aug. 30.

Swine Flu Prevention Slideshow

Swine Flu Prevention Powerpoint Slide Show

Produced by www.puracleenrx.com . The Swine Flu Pandemic is becoming a major problem all over the world. The CDC (Centers for Disease Control) is already showing 77 countries affected with the influenza A (H1N1) virus as of November 5, 2009. Some good and bad information has been published about the H1N1 influenza virus including tips on prevention and controlling H1N1 outbreaks once they occur. We have decided to do some research on these facts and myths about the H1N1 Swine Flu Virus. We want to provide you with the best and most factual information available to keep you and your family as safe and healthy as possible.

Swine Flu Facts-V2

Swine Flu and Seasonal Flu

Flu activity in the U.S. is reported to now be widespread in 41 states. Across the nation visits to doctors for influenza-like-illness continued to be on the rise and are now about equal to or higher than what is seen at the height of most normal flu seasons. Flu-related hospitalizations and deaths are also continuing to mount and are above expectations for this time of year.

The CDC continues to remind health providers and the public of the need to continue hand and cough hygiene measures for the period of any influenza symptoms, even while taking antiviral medications in order to combat the spread of antiviral resistant virus strains. The influenza activity reported by both state and territorial epidemiologists shows geographic spread of both seasonal influenza and 2009 influenza A (H1N1) viruses.

Each week CDC evaluates information collected about influenza disease activity in the United States and issues findings of key flu indicators in a report called FluView. A review of the key indictors found that during the week of October 4-10, 2009 influenza activity continued to increase in the United States from the previous week. Below is a summary of the latest significant indicators:

· Visits to doctors for influenza-like illness (ILI) continued to increase in the United States, and overall, are higher than what is expected for this time of the year. ILI activity now is equal to or higher than what is seen at the peak of many regular flu seasons.

· Total influenza hospitalization rates for laboratory-confirmed flu are climbing and are higher than expected for this time of year.

· The proportion of deaths attributed to pneumonia and influenza (P&I) based on the 122 Cities Report has increased and exceeds what is normally expected at this time of year. In addition, 11 flu-related pediatric deaths were reported this week; 10 of these deaths were confirmed 2009 H1N1, and one was influenza A virus, but unsubtyped. Since April 2009, there have been 86 confirmed pediatric 2009 H1N1 deaths; 39 of these have been reported to CDC since August 30, 2009.

· Forty-one states are reporting widespread influenza activity at this time. They are: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Texas, Tennessee, Utah, Virginia, Washington, West Virginia, Wisconsin, and Wyoming. This many reports of widespread activity are unprecedented during seasonal flu.

· Almost all of the influenza viruses identified so far is 2009 H1N1 influenza A viruses. These viruses remain similar to the virus chosen for the 2009 H1N1 vaccine, and remain susceptible to the antiviral drugs oseltamivir and zanamivir with rare exception.

CDC New Conference Video

Swine Flu on the Rise

Normally found in pigs, swine flu is a highly contagious acute respiratory disease.  It spreads through tiny particles in the air or by direct contact.  According to the World Health Organization (WHO) it has a tendency to infect large numbers of the pig population.   Not every animal infected displays symptoms but the flu kills between 1 and 4 percent of those affected.  Humans usually become infected through contact with pigs; though in some cases human-to-human transmission has been reported.

The recent swine flu outbreak appears to have caused fatalities in humans in Mexico as well as nonfatal cases in the United States. WHO has urged countries around the world to be alert for dubious cases of influenza.  Comparisons with the 1918 epidemic are premature, but WHO Chief Margaret Chan says the global body is taking the outbreak very seriously. Serious study and monitoring is needed and preventing the spread of swine flu is key to stopping it from becoming an pandemic.

Since the swine flu outbreaks in Mexico and U.S. were first noted, the risk of a pandemic has grown.  Health officials worry the swine flu might progress into a variety more easily spread among humans.  Experts worry that it is more likely a pandemic strain will emerge the more the virus circulates.  Though there is no way to accurately predict when and if that will happen.

Swine flu is considered widespread in the United States even though in North America pigs are routinely vaccinated for swine flu.  There is no vaccine for humans at this time.  The flu virus evolves quickly, making vaccines obsolete as almost as soon as developed.  There is no implication that the vaccine prepared for seasonal flu will defend against swine flu according to health officials.

Good hygiene is necessary in terms of prevention. Regular hand-washing and staying a safe distance from those infected are advised.  Q-Based Healthcare offers a variety of products to help with disinfecting needs.   PuraCleenRx READY-TO-USE Disinfectant Spray is designed specifically as a general non-acid cleaner and disinfectant for use in homes, hospitals, nursing homes, patient rooms, operating rooms, ICU areas, schools, transportation terminals, office buildings, manufacturing facilities, lodging establishments, retail businesses, veterinary clinics, pet shops, animal life science laboratories and athlete/recreational facilities where housekeeping is of prime importance in controlling the hazard of cross contamination.

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