Posts Tagged ‘treatment’

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.

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 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.

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 Outbreak

Swine Flu has been the topic of conversation today on everyone’s lips. Swine flu is a respiratory disease in pigs which is caused by type A influenza viruses. Before 2009 there has rarely been a case reported in humans. Swine flu is known to be contagious and spread by person to person contact. Some symptoms may include fever, couching, sore throat, headaches, chills, diarrhea, fatigue and vomiting. There have been some reported deaths from swine flu in Mexico.

The CDC (Center for Disease Control) reported 8 Swine Flu cases in the United States on 4/25/09. Since then the toll has reached a total count of 40 cases in the US alone. These cases have been reported in California, Kansas, New York, Ohio and Texas. This outbreak seems to have started and spread to other countries including Spain, Mexico and Canada. This is a report from the CDC on recent devolpments in the swine flu epidemic.

The World Health Organization has declared this outbreak at a level four on a six-point scale for the pandemic alert level. It has been reported as many as 149 deaths in Mexico due to this outbreak of swine flu. Currently no deaths have been reported in the United States. The Obama Administration has been reported as saying they are responding aggressively towards the outbreak in case it spreads into a full pandemic. Also travel warnings have been issued for trips to and from areas affected by the outbreak.

People have been asking what can be done for the prevention of swine flu. One important tip suggested is to wash your hands regularly with an antimicrobial soap, such as All Stop Medicated Body Wash. It is also important to cover your nose and mouth when coughing or sneezing. Try to avoid touching your eyes, ears and nose because these places on the body spread germs quickly. Hand cleansers have also been suggested for use to stop the germs from spreading with person to person contact. All Stop Healing Gel can be used on the hands to prevent viruses from spreading from contact with infected individuals. Cleaning your environment is also a useful tip to prevent swine flu. Germs from viruses can live off of the body on inanimate objects such as doorknobs, desks, subway railings or tabletops for two hours or even longer if not properly disinfected. PuraCleenRx Disinfectant Spray and Xtreme Cleen are both safe an nontoxic anti-bacterial and anti-viral disinfectants that can be used on any surfaces. If you do come in contact with the swine influenza please act immediately for your safety and that of others. For more information on the swine flu outbreak feel free to visit www.prevent-swine-flu.com.

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