Posts Tagged ‘swine 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 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.

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.

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.

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.

Critical H1N1 Swine Flu Facts

The CDC is recommending all healthcare providers receive both the seasonal influenza vaccine every year and the 2009 H1N1 vaccine. Healthy persons including healthcare providers, who are infected with influenza virus, can transmit the virus to persons at higher risk for complications from influenza, like patients with inflammatory rheumatic disease.

Early treatment with oseltamivir or zanamivir should be contemplated for persons with flu-like symptoms, suspected or confirmed, who have an elevated risk for complications including patients with inflammatory rheumatic disease. Patients with inflammatory rheumatic disease within any of the following prioritized groups are recommended to receive the 2009 H1N1 vaccine:

  • Pregnant women
  • People who live with or care for children younger than 6 months of age
  • Healthcare and emergency medical services personnel
  • Persons between the ages of 6 months and 24 years old
  • Persons between the ages of 25 and 64 years old who are at higher risk for 2009 H1N1 because of chronic health disorders or compromised immune systems (including with inflammatory rheumatic disease)

Persons age 65 or older are not included in these specific groups because recent research indicates that the chance of infection among persons age 65 or older is less than the chance for younger age groups. While not expecting a shortage of 2009 H1N1 vaccine, the CDC states that availability and demand can be unpredictable. Once the need for the vaccine among the younger groups has been taken care of, the vaccine should be offered to people age 65 or older, including people with inflammatory arthritis.  Persons with inflammatory rheumatic disease who develop flu-like symptoms need to know the following:

  • If you develop flu-like symptoms contact your healthcare provider.
  • Avoid contact with others. Seek medical care early. You should stay home and avoid travel, including not going to work or school, until at least 24 hours after your fever is gone except to get medical care or necessities. Your fever should be gone without using fever-reducing medications.
  • If you leave the house to seek medical care, wear a facemask, if available and tolerable, and cover your coughs and sneezes with a tissue.
  • Do not stop taking any medicine you take for your arthritis unless told to do so by your physician.
  • Seek medical attention early. Treatment is available for persons with severe disease and those at high risk for complications. Persons with inflammatory rheumatic disease are considered high risk for complications from the flu; therefore, your health care provider may choose to prescribe antiviral medications for you if you get the flu.
  • If you are exposed to someone who has flu, consult your health care provider.  They may prescribe medication to help prevent you from getting the flu or watch you closely to see if you develop flu symptoms.

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.

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