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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.

Prevent Swine Flu Tips 2

If you find yourself in the position of having to take care of a family or household member who is sick with the flu there are steps to take to protect yourself and others who are not sick.  This first step is you should keep the sick person away from other people as much as possible especially others who are at high risk for complications from influenza like illnesses.  This includes making people who are sick with any influenza like illness stay home and keep away from others as much as possible. They should avoid traveling for at least 24 hours after fever has abated.

Remind the flu sufferer to cover their coughs, and clean their hands with soap and water often.  If soap and water are not available, they should use an alcohol-based hand sanitizer, especially after coughing and/or sneezing.  You should have everyone in the household clean their hands often, using soap and water or hand sanitizer. Children may need repeated reminders or even help keeping their hands clean.

It is a good idea to ask your health care provider if household contacts of the sick person, should take antiviral medications such as oseltamivir (Tamiflu®) or zanamivir (Relenza®) to prevent getting the flu themselves. This is especially important for those who may be pregnant or have chronic health conditions Persons with the flu should use a separate bathroom. This bathroom should be cleaned on a daily basis with a disinfectant of somekind.

Anyone who falls into a high risk group for complications from influenza should attempt to avoid close contact with household members who are sick with influenza. If close contact with a sick individual cannot be avoided consider wearing a facemask.  Infants should never be cared for by family members or persons with the flu.

Keep in mind that the sick person should not have visitors other than the person caring for them. A phone call is much better than a visit.  If possible, have only one adult in the home take care of the sick person. It is not people at increased risk of severe illness from flu should not be the designated caretaker. Having pregnant women care for the sick person should be avoided because pregnant women are at increased risk of influenza-related complications and immunity can be suppressed during pregnancy.

All persons in the household should clean their hands with soap and water often.  This includes after every contact with the sick person or the person’s room or bathroom where you may pick up germs. Use paper towels for drying hands after hand washing.  Another option is to set aside cloth towels to each person in the household. Using different colored towels for each person makes this easier to keep track of.

H1N1 Facts and Information

Swine flu or swine influenza or influenza A h1n1 is defined as a respiratory disease caused by influenza viruses that infect the respiratory tract of pigs and result in nasal secretions, a barking-like cough, decreased appetite, and listless behavior. Swine flu produces most of the same symptoms in pigs as human flu produces in people. Swine flu can last about one to two weeks in pigs that survive. Swine influenza virus was first isolated from pigs in 1930 in the U.S. and has been recognized by pork producers and veterinarians to cause infections in pigs worldwide.

In a number of instances, people have developed the swine flu infection when they are closely associated with pigs and likewise, pig populations have occasionally been infected with the human flu infection. Farmers and pork processors are at the highest risk. In most instances, the cross-species infections (swine virus to man; human flu virus to pigs) have remained in local areas and have not caused national or worldwide infections in either pigs or humans.

Regrettably, this cross-species infection with influenza viruses has had the capability to transform. Researchers think the 2009 swine flu strain, first seen in Mexico, should be called novel H1N1 flu since it is predominately found infecting people and exhibits two main surface antigens, H1 (hemagglutinin type 1) and N1 (neuraminidase type1). Current research shows the eight RNA strands from novel H1N1 flu have one strand derived from human flu strains, two from avian (bird) strains, and five from swine strains.

In areas with confirmed human cases of swine influenza A (H1N1) virus infection, the possibility of infection can be lessened through a combination of actions. No single action will provide complete protection, but an approach combining the following steps can help decrease the likelihood of transmission. These steps include frequent washing hands frequently, covering coughs, and having ill persons remain at home, except to seek medical care, and minimize contact with others in the household. Additional measures that can limit transmission of a new influenza strain include voluntary home quarantine of members of households with confirmed or probable swine influenza cases, reduction of unnecessary social contacts, and avoidance whenever possible of crowded settings.

A confirmed case of swine influenza A (H1N1) virus infection is defined as a person with an acute respiratory illness with laboratory confirmed swine influenza A (H1N1) virus infection at CDC by either a real-time RT-PCR or viral culture test.

For antiviral treatment of a confirmed case of swine influenza A (H1N1) virus infection, either oseltamivir or zanamivir may be administered. The recommended length of treatment is five days. These same antivirals should be considered for treatment of cases that test positive for influenza A but test negative for seasonal influenza viruses H3 and H1.

What You Can Do to Stay Healthy

Hot List: What You Can Do to Stay Healthy

According to the latest information the government recommendations to
avoid contracting swine flu include these simple steps. Of course this
is not an all inclusive list and some items on the list are impossible
to do — like getting a vaccination right now but here is the best
list we have:

Get vaccinated. Vaccination is the best protection we have against
flu. Seasonal flu vaccine is available now and initial doses of 2009
H1N1 flu vaccine also are available, with additional doses available
later this year.
Influenza is thought to spread mainly person-to-person through
coughing or sneezing of infected people.
Take everyday actions to stay healthy.

Cover your nose and mouth with a tissue when you cough or sneeze.
Throw the tissue in the trash after you use it.
Wash your hands often with soap and water. If soap and water are not
available, use an alcohol-based hand rub.
Avoid touching your eyes, nose and mouth. Germs spread that way.
Stay home if you get sick. CDC recommends that you stay home from work
or school and limit contact with others to keep from infecting them.

Follow public health advice regarding school closures, avoiding crowds
and other social distancing measures.
Find healthy ways to deal with stress and anxiety.
Stay informed. This website will be updated regularly as information
becomes available.
Call 1-800-CDC-INFO for more information.

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

Latest CDC Advisory

The ongoing outbreak of novel influenza A (H1N1) continues to expand in the United States and internationally. CDC expects that more cases, more hospitalizations and more deaths from this outbreak will occur over the coming days and weeks.

CDC continues to take aggressive action to respond to an expanding outbreak caused by novel H1N1 flu.

CDC’s response goals are to:

  1. Reduce transmission and illness severity, and
  2. Provide information to help health care providers, public health officials and the public address the challenges posed by this emergency.

CDC is issuing updated interim guidance daily in response to the rapidly evolving situation. This includes updated interim guidance for clinicians on how to identify and care for people who are sick with novel H1N1 flu now that more widespread illness has been detected in the United States. CDC recommends that testing and antiviral treatment be prioritized for those with severe respiratory illness and those at highest risk of complications from seasonal influenza. This includes children younger than 5 years old, pregnant women, people with chronic medical conditions and weakened immune systems, and people 65 years and older. In addition, CDC has provided information for the public on what to do if they develop flu-like symptoms.

CDC has completed deployment of 25 percent of the supplies in the Strategic National Stockpile (SNS) to all states in the continental United States. These supplies and medicines will help states and U.S. territories respond to the outbreak. In addition, the Federal Government and manufacturers have begun the process of developing a vaccine against the novel H1N1 flu virus.

Response actions are aggressive, but they may vary across states and communities depending on local circumstances. Communities, businesses, places of worship, schools and individuals can all take action to slow the spread of this outbreak. People who are sick are urged to stay home from work or school and to avoid contact with others, except to seek medical care. This action can avoid spreading illness further.

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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