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 vs Seasonal Flu
Like seasonal flu, 2009 H1N1 flu in humans can fluctuate in seriousness from mild to severe. Formerly known as swine flu, the 2009 H1N1 flu virus infection can cause a wide range of symptoms, including fever, cough, sore throat, runny or stuffy nose, body aches, headache, chills and fatigue. Some people with the flu may also experience symptoms of vomiting and diarrhea. It has been noted that certain groups might be more likely to develop a severe illness from 2009 H1N1 flu infection, such as pregnant women and persons with chronic medical conditions.
Influenza viruses are thought to spread from person to person by respiratory droplets coming from coughs and sneezes of an infected person. This can happen when droplets from a cough or sneeze of an infected person are spread through the air and settles on the mouth or nose of someone close by. Influenza viruses may also be spread when a person touches respiratory droplets that may be on another person or an object and then touches their own mouth or nose before washing their hands.
The preferred course of action, of course, would be to avoid close contact with persons infected with the flu as much as humanly possible. Close contact would be considered less than about 6 feet away from the infected person. If you must come into contact with a sick person spend the least amount of time possible near them and try to wear a facemask or surgical mask or N95 disposable respirator if at all possible. An N95 respirator that fits snugly on your face can filter out small particles that can be inhaled around the edges of a facemask. It may harder to breathe through an N95 mask for long periods of time compared to a facemask. Facemasks and respirators can be found for purchase at a pharmacy, building supply or hardware store.
Some helpful hints to keep in mind if you find yourself in need of wearing a facemask or N95 respirator are the following:
- Wear an N95 respirator if you help a sick person with respiratory treatments using a nebulizer or inhaler, as directed by their doctor. Respiratory treatments should be performed in a separate room away from common areas of the house when at all possible.
- Used facemasks and N95 respirators should be taken off and placed immediately in the regular trash so they don’t touch anything else.
- Avoid re-using disposable facemasks and N95 respirators, if possible. If a reusable fabric facemask is used, it should be laundered with normal laundry detergent and tumble-dried in a hot dryer.
- After you take off a facemask or N95 respirator, clean your hands with soap and water or an alcohol-based hand sanitizer.
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.
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 Check List
Things to look for – protect yourself from H1N1
How do you Prevent Flu?
Experts are recommending that if you are showing signs of flu-like symptoms this flu season, staying home and avoiding contact with other people except to get medical care is the best option. The thought is to keep the spread of flu-like symptoms to a minimum. Most people who have come down with the 2009 H1N1 have had mild illness and have not needed medical care or antiviral drugs. This is also true of seasonal flu.
In the event that you are one of the people who are more likely to get flu complications then you should talk to a health care provider about whether you need to be examined if you get flu symptoms this season. People who fall into a higher risk category are children younger than 5, but especially children younger than 2 years old, people 65 and older and pregnant women. Others at risk are people who have the following:
o Cancer
o Blood disorders (including sickle cell disease)
o Chronic lung disease [including asthma or chronic obstructive pulmonary disease (COPD)]
o Diabetes
o Heart disease
o Kidney disorders
o Liver disorders
o Neurological disorders (including nervous system, brain or spinal cord)
o Neuromuscular disorders (including muscular dystrophy and multiple sclerosis)
o Weakened immune systems (including people with AIDS)
There are drugs your doctor may prescribe for treating both seasonal and 2009 H1N1 called antiviral drugs. These drugs can make you better faster and may also prevent serious complications. This flu season, antiviral drugs are being used mainly to treat people who are very sick, such as people who need to be hospitalized, and to treat sick people who are more likely to get serious flu complications like those mentioned above. Your health care provider will decide whether antiviral drugs are needed to treat your illness. If you get sick with flu symptoms and are at high risk of flu complications or you are concerned about your illness, talk to your doctor. It is not advised to go to the emergency room because if you do not have the flu, you may catch it from sick people who are there.
Symptoms of the flu could be one or a combination of fever, cough, sore throat, runny or stuffy nose, body aches, headache, chills, fatigue and sometimes diarrhea and vomiting. An important side note to keep in mind is that not everyone suffering from the flu will show signs of a fever. Remember, most people with 2009 H1N1 have had mild illness and have not needed medical care or antiviral drugs and the same is true of seasonal flu. Also, it’s possible for healthy people to develop severe illness from the flu so anyone concerned about their illness should consult a health care provider.
H1N1 Swine Flu in Teens and Young Adults
H1N1 Vaccine – Jury is still out
Teens and young adults continue to account for the majority of cases of H1N1 around the world, with numbers of hospitalized cases highest in very young children. One% to ten% of patients with clinical illnesses will require hospitalization. Of those hospitalized patients anywhere from 10% to 25% will need to be admitted to an intensive care unit. Of those cases, 2% to 9% end up being fatal. This information is according to the Strategic Advisory Group of Experts (SAGE) on Immunization, which advises the World Health Organization (WHO) on policies and strategies for vaccines and immunization.
A recent session of the SAGE October 27th – 29th meeting was dedicated to the discussion of pandemic influenza vaccines. The experts at SAGE reviewed the current epidemiological situation of the pandemic worldwide and considered issues and options from a public health perspective. Overall, from 7% to 10% of all hospitalized patients are pregnant women in their second or third trimester of pregnancy. Pregnant women are ten times more likely to need care in an intensive care unit when compared with the general population. Based on data and the substantially elevated risk for a severe outcome in pregnant women infected with the pandemic virus, The Strategic Advisory Group of Experts on Immunization (SAGE) recommended that any licensed vaccine can be used in pregnant women, provided no specific opposition has been identified by the regulatory authority.
The SAGE experts also advised WHO on the number of doses of vaccine needed to provide protection across all different age groups, the joint dispensing of seasonal and pandemic vaccines, and vaccines for use in pregnant women. Recommendations on the formulation of seasonal influenza vaccines for the southern hemisphere in 2010 were also provided. Other agenda items discussed included the status of vaccine availability, results from clinical trials on vaccine immunogenicity, and early results from safety monitoring in countries where dispensation of the H1N1 pandemic vaccine is currently under way.
Early results of the monitoring of people who have received pandemic vaccines were reviewed by the experts from SAGE and there were no indications of unusual adverse reactions found. Some adverse events following vaccination have been noticed, but these are well within the range of those seen with seasonal vaccines. All of which are believed to have an excellent safety profile. Although early results are encouraging, they suggested monitoring for adverse events should be continued. The group also suggested that data on immunogenicity in children older than 6 months and younger than 10 years are limited and more studies are needed. National authorities have made children a priority for early vaccination. The SAGE recommendation is that precedence be given to the allocation of one dose of vaccine to as many children as possible.
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.
Healthcare Products to Prevent Swine Flu Part 1
Recent government information is focused on informing the consumer that the most effective method to prevent the spread of H1N1 Influenza (known by most as swine flu) is through the use of their hurried rushed to market vaccine.
While this may be true in the grand scheme of things it does very little to reassure the millions of people who have a hard time trusting vaccinations — and for some an even harder time trusting their government. Beyond the deep concerns we decided to examine the language of the recent news and guidance from the CDC and other authority sources on swine flu.
We found the usage of the phrase ‘most effective method to prevent the spread of H1N1 Influenza’ to be a bit concerning because this seems to suggest the governments primary concern is the prevention of the spread of swine flu. You can read that to mean their main intent it is calm the population and stem fears of a wider spread of this pandemic.
So what about the rest of us? What do we use as a yardstick to determine how effective a solution is — beyond just getting vaccinated? You still have to protect yourself, wash your hands frequently and clean your environment. Right?
Well with the recent news of a registered nurse dying of flu like symptoms we now begin to wonder if the message is also focused on reducng the level of alarm in the healthcare professional community. That begs the question:
What do healthcare workers do to prevent swine flu, or rather, What do healthcare workers do to prevent H1N1?
Considering their fate rest daily in their methods of staying clean and virus free we decided to try and locate the products they use to stay safe on the job and to make sure they do not take deadly illnesses home with them.
Fact #1: Clean Your Environment
Depending on how cold it is (ambient room temperature) a virus deposited on a hard surface by a sneeze or contact transmission can remain alive and viable from 2 hours to up to 48 hours. This can make the healthcare environment a hazardous place to sped your day. So what do healthcare environmental services use to clean hard surfaces? And can the average consumer get their hands on this product?
The answer is yes.
Although not under the same tradename as the formula sold to hospitals, there is a highly concentrated virucide – bacteriacide – and fungicide that is available to consumers. We tracked down one of these products and are advertising it through our website. We choose not to mention it directly in this article because we do not wish to unfairly favor one product over another. Also there may be other products that are proven effective against h1n1 virus on hard surfaces, but we have independantly confirmed this product is safe, affordable and proven effective against h1n1 swine flu on hard surfaces.Also note that 1 gallon of this concentrate make 64 gallons of virucide – more than enough to clean the average home though the winter season.
Visit our website at http://prevent-swine-flu.com for more information and to learn about healthcare products to prevent swine flu.
Prevent Swine Flu Tip 1
The CDC says that a good way to prevent any flu disease is to avoid exposure to the virus. This is done by frequent hand washing, not touching your hands to your face. Be especially careful to avoid the nose and mouth and avoiding any close proximity to or touching any person who may have flu symptoms. Since the virus can remain live and infectious for about 48 hours on many surfaces it is essential to practice good hygiene like cleaning with soap and water or alcohol-based hand disinfectants. Some physicians say face masks may help prevent getting airborne flu viruses from a cough or sneeze but others think it would be better for the people who actually have symptoms and sneeze or cough to wear the masks.
The use of Tamiflu or Relenza may help prevent the flu if taken before symptoms develop or reduce symptoms if taken within about 48 hours after symptoms develop. The vaccine recommendations as of October 2009 from the CDC say the following groups should get the vaccine as soon as it is available:
* people who live with or provide care for children younger than 6 months of age,
* pregnant women,
* health-care and emergency medical services personnel,
* people between 6 months and 24 years of age, and
* people from the ages of 25 through 64 who are at higher risk because of chronic health disorders such as asthma, diabetes, or a weakened immune system.
Generally speaking, about 90%-95% of people who get the disease feel dreadful but eventually bounce back with no problems. This has been seen in patients in both Mexico and the U.S. Caution is still crucial as the swine flu (H1N1) is still spreading and has become a pandemic. So far, young adults been hit hardest, and in Mexico, this group currently has the highest mortality rate. This data however is constantly changing.
At this time the CDC is stating that people ages 10 and above are likely to need only one vaccine shot to provide protection against novel H1N1 swine flu and further suggest that these shots will be effective in about 76% of people who obtain the vaccine. One type of vaccine (currently named Influenza A [H1N1] 2009 Monovalent Vaccine Live, Intranasal) has been made available during the first week in October 2009. It is a live attenuated novel H1N1 flu vaccine that contains no thimerosal. This vaccine is produced by MedImmune, LLC, and is administered by spraying it into the nostrils. This vaccine is only for healthy people 2-49 years of age. Children 2-9 years of age should receive two doses (0.1 ml in each nostril; total equals 0.2 ml per dose) and the second dose should be given the same way about one month after the first dose. Children, adolescents and adults, 10-49 years of age should receive one dose (0.1 ml in each nostril; total equals 0.2 ml per dose).
Swine Flu Death Tracking System
Pneumonia and Influenza Hospitalization and Death Tracking system was implemented on August 30, 2009, and replaces the weekly report of laboratory confirmed 2009 H1N1-related hospitalizations and deaths that began in April 2009. Jurisdictions can now report to CDC either laboratory confirmed or pneumonia and influenza based counts of hospitalizations and deaths resulting from all types or subtypes of influenza, not just those from 2009 H1N1 influenza virus. To allow jurisdictions to implement the new case definition, counts were reset to zero on August 30, 2009. From August 30 – October 10, 2009, 4,958 laboratory-confirmed influenza associated hospitalizations, 292 laboratory-confirmed influenza associated deaths, 15,696 pneumonia and influenza syndrome-based hospitalizations, and 2,029 pneumonia and influenza syndrome-based deaths, were reported to CDC. CDC will continue to use its traditional surveillance systems to track the progress of the 2009-10 influenza season.
A flu pandemic occurs when a new influenza A virus emerges for which there is little or no immunity in the human
population. As we have seen the virus causes serious illness and spreads easily from person-to-person worldwide. On June 11, 2009, the World Health Organization (WHO) declared that a global pandemic of H1N1 flu is in progress. Nearly 5,000 people have died from swine flu infections since the A(H1N1) virus made its debut in April, the World Health Organization said on Friday. The death toll marked an increase of about 265 over the 4,735 deaths reported to the WHO a week ago. The majority of the fatal cases which number 3,539 have been recorded in North and South America, the UN health agency said in its latest update on the escalating flu pandemic.
Overseas countries like Iceland, Sudan, and Trinidad and Tobago reported their first fatal cases over the past week. Mongolia, Rwanda, and Sao Tome and Principe also recorded pandemic influenza cases for the first time, as the virus continued to spread. Perhaps some good news is the A(H1N1) influenza was declining in tropical areas of the world. That is with the exception of Cuba and Colombia. There was also no significant pandemic related activity over the past week in warmer areas of the southern hemisphere, the WHO said. At this time respiratory disease activity persists in spreading and growing in intensity in the northern hemisphere, predominately in North America. Extensive efforts are ongoing to track and monitor the spread of all flu viruses. In the U.S., epidemiologists at the Centers for Disease Control (CDC) are working diligently with the states affected to collect, compile and analyze reports of flu outbreaks. As of September 2009, the current calculations are that about 90,000 deaths will take place in the U.S. from novel H1N1 swine flu. This is the estimate set out by the president’s advisory committee. There has been no revision of these numbers by the advisory committee or the CDC as of October 2009.

