Interim Guidance for Clinicians & Public Health Professionals
Clinicians
Clinicians should consider the possibility of swine influenza virus infections in patients presenting with febrile respiratory illness.
If swine flu is suspected, clinicians should obtain a respiratory swab for swine influenza testing and place it in a refrigerator (not a freezer). Once collected, the clinician should contact their state or local health department to facilitate transport and timely diagnosis at a state public health laboratory.
State Public Health Laboratories
Laboratories should send all unsubtypable influenza A specimens as soon as possible to the Viral Surveillance and Diagnostic Branch of the CDC’s Influenza Division for further diagnostic testing.
Public Health and Animal Health Officials
Officials should conduct thorough case and contact investigations to determine the source of the swine influenza virus, extent of community illness and the need for timely control measures.
Interim Guidance for Screening for Swine-Origin Influenza A (H1N1) by State and Local Health Departments, Hospitals, and Clinicians in Regions with Few or no Reported Cases of Swine Influenza A (H1N1)
April 29, 2009 12:30 PM ET
This document provides interim guidance for state and local health departments, hospitals, and clinicians in regions with few or no reported cases of swine-origin influenza A (H1N1) (S-OIV) regarding which patients to evaluate for possible infection with swine influenza A (H1N1). As of April 29 1:00 PM, there were 91 laboratory confirmed cases of S-OIV infection identified in 14 states in the United States. Human cases of S-OIV infection also have been identified internationally. Based on the rapid spread of the S-OIV thus far, public health officials believe that more cases will be identified over the next several weeks, including in regions that currently have few or no reported cases.
CDC recommends that state and local health departments, hospitals, and clinicians in regions with few or no reported cases of S-OIV consider the following recommendations for testing of the following persons for S-OIV infection with a nasopharyngeal swab by PCR:
1. Patients presenting to providers participating in the US Outpatient Influenza-like Illness Surveillance Network (ILINet) who meet the case definition of influenza-like illness (ILI), or
2. Patients with an ILI who have traveled within 7 days to a community either within the United States or internationally where there are one or more confirmed swine influenza A (H1N1) cases, or
3. Patients admitted to the hospital with an ILI.
ILI is defined as fever (temperature of 100°F [37.8°C] or greater) and a cough and/or a sore throat in the absence of a KNOWN cause other than influenza.
Specimen Collection and Testing
If swine flu is suspected, clinicians should obtain a respiratory swab for S-OIV testing and place it in a refrigerator (not a freezer). Once collected, the clinician should contact their state or local health department to facilitate transport and timely diagnosis at a state public health laboratory. State public health laboratories should perform subtype testing on all influenza A positive samples identified. State public health laboratories should submit all specimens that cannot be subtyped as human influenza A (H1N1) or (H3N2) to CDC for identification. Please notify CDC of all pending shipments by email at eocsciresource@cdc.gov or if email is not available, by phone at 404-553-7724. Please include shipment tracking information.
Investigation of Cases
Officials should conduct thorough case and contact investigations to determine the source of the swine influenza virus, extent of community illness and the need for timely control measures.
Interim Guidance
• Interim Guidance is available, including:
• Case definitions to be used for swine influenza A (H1N1) cases
• Antiviral recommendations for patients with confirmed or suspected S-OIV infection and close contacts
• Infection control for care of persons with confirmed or suspected S-OIV infection in a healthcare setting
• S-OIV biosafety guidelines for laboratory workers.
Interim Guidance on Specimen Collection, Processing, and Testing for Patients with Suspected Swine-Origin Influenza A (H1N1) Virus Infection
April 29, 2009 2:00 AM EDT
Objective: To provide interim guidance on appropriate specimen collection, storage, processing, and testing for patients with suspected swine-origin influenza A (H1N1) virus infection.
Case Definitions
A confirmed case of S-OIV infection is defined as a person with an acute febrile respiratory illness with laboratory confirmed S-OIV infection at CDC by one or more of the following tests:
1. real-time RT-PCR
2. viral culture
Case definitions for probable and suspected cases can be found at: http://www.cdc.gov/swineflu/casedef_swineflu.htm
Duration of viral shedding
The duration of shedding with swine-origin influenza A (H1N1) virus is unknown. Therefore, until data are available, the estimated duration of viral shedding is based upon seasonal influenza virus infection. Infected persons are assumed to be shedding virus and potentially infectious from the day prior to illness onset until resolution of fever. Infected persons should be assumed to be contagious up to 7 days days from illness onset. Some persons who are infected might potentially shed virus and be contagious for longer periods (e.g. young infants, immunosuppressed, and immunocompromised persons).
Testing for swine-origin influenza A (H1N1) virus
Clinicians should consider testing suspected cases of swine-origin influenza A (H1N1), especially those with severe illness, by obtaining an upper respiratory specimen to test for swine-origin influenza A (H1N1) virus.
Preferred respiratory specimens: The following should be collected as soon as possible after illness onset: nasopharyngeal swab/aspirate or nasal wash/aspirate. If these specimens cannot be collected, a combined nasal swab with an oropharyngeal swab is acceptable. For patients who are intubated, an endotracheal aspirate should also be collected. Specimens should be placed into sterile viral transport media (VTM) and immediately placed on ice or cold packs or at 4°C (refrigerator) for transport to the laboratory. Recommended infection control guidance is available for persons collecting clinical specimens: http://www.cdc.gov/swineflu/guidelin...on_control.htm and for laboratory personnel: http://www.cdc.gov/swineflu/guidelines_labworkers.htm
Swabs
Ideally, swab specimens should be collected using swabs with a synthetic tip (e.g. polyester or Dacron®) and an aluminum or plastic shaft. Swabs with cotton tips and wooden shafts are not recommended. Specimens collected with swabs made of calcium alginate are not acceptable. The swab specimen collection vials should contain 1-3ml of viral transport medium (e.g. containing, protein stabilizer, antibiotics to discourage bacterial and fungal growth, and buffer solution), such M4RT or the BD Universal Viral Transport System (BD - Diagnostic Systems: Universal Viral Transport Polyester Swabs )
Storing Clinical Specimens: All respiratory specimens should be kept at 4°C until they can be placed at -70°C. If a -70°C freezer is not available, specimens should be kept at 4°C, preferably no longer than 1 week.
Shipping clinical specimens: Clinical specimens should be shipped on dry ice in appropriate packaging.
All specimens should be labeled clearly and include information requested by your state public health laboratory. Suspected case specimens shipped from the state public health laboratory to CDC should include all information required for seasonal influenza surveillance isolate or specimen submission.
Recommended Tests
Real-time RT-PCR for influenza A, B, H1, H3 at a State Health Department Laboratory is recommended. Currently, swine-origin influenza A (H1N1) virus will test positive for influenza A and negative for H1 and H3 by real-time RT-PCR. If reactivity of real-time RT-PCR for influenza A is strong (e.g. Ct <30) it is more suggestive of a novel influenza A virus. Confirmation as swine-origin influenza A (H1N1) virus is performed at CDC currently, but may be available in state public health laboratories soon.
Other influenza tests
Rapid influenza antigen test: Also, these tests have unknown sensitivity and specificity to detect human infection with swine-origin influenza A (H1N1) virus in clinical specimens, and have suboptimal sensitivity to detect seasonal influenza viruses. Therefore, a negative rapid test could be a false negative and should not be assumed a final diagnostic test for swine-origin influenza infection.
Immunofluorescence (DFA or IFA): These tests can distinguish between influenza A and B viruses. A patient with a positive for influenza A by immunofluorescence may meet criteria for a suspected case. However, it is not possible to differentiate from seasonal influenza A viruses. Immunofluorescence depends upon the quality of a clinical specimen, operator skills, and has unknown sensitivity and specificity to detect human infection with swine-origin influenza A (H1N1) virus in clinical specimens. Therefore, a negative immunofluorescence could be a false negative and should not be assumed a final diagnostic test for swine-origin influenza infection.
Viral culture: Isolation of swine-origin influenza A (H1N1) virus is diagnostic of infection, but may not yield timely results for clinical management. A negative viral culture does not exclude infection with swine-origin influenza A (H1N1) virus.

Swine Flu: Emergency Use Authorization (EUA) of Medical Products and Devices
April 29, 2009, 1:45 AM ET
What is EUA?
Interim Questions and Answers About Emergency Use Authorization
April 29, 2009, 1:45 AM ET
See also the FDA’s Emergency Use Authorization of Medical Products Guidance.
1. What is an emergency use authorization?
An Emergency Use Authorization (EUA) may be issued by the Food and Drug Administration (FDA) to allow either the use of an unapproved medical product or an unapproved use of an approved medical product during certain types of emergencies with specified agents.
Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act), amended by the Project BioShield Act of 2004, permits authorization of such products for use in diagnosing, treating, or preventing serious or life-threatening diseases or conditions caused by biological, chemical, radiological, or nuclear agents, if certain statutory criteria are met.
2. What is required before the FDA may issue an EUA?
The Act requires that, before an emergency use may be authorized, the Secretary of the Department of Health and Human Services (HHS) must declare an emergency justifying the emergency use, based on one of the following grounds:
(1) The Secretary of the Department of Homeland Security determines that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agents; or
(2) The Secretary of the Department of Defense determines that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces of attack with a specified biological, chemical, radiological, or nuclear agent or agents; or
(3) The HHS Secretary determines that there is a public health emergency under the Public Health Service Act (PHS Act) that affects, or has a significant potential to affect, national security, and involves a specified biological, chemical, radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such agent or agents.
3. On what basis may the FDA issue an EUA?
Once the HHS Secretary has declared an emergency justifying the emergency use, the FDA Commissioner may authorize an emergency use only if, after consultation with the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) (to the extent feasible and appropriate given the circumstances of the emergency), he determines that certain statutory criteria have been met. Specifically, the Commissioner must conclude, as follows:
1. That the agent specified in the declaration of emergency can cause a serious or life-threatening disease or condition;
2. That, based on the totality of scientific evidence available, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that the product may be effective in diagnosing, treating, or preventing—

(a) The serious or life threatening disease or condition, or

(b) A serious or life-threatening disease or condition caused by a product authorized under section 564, or approved, cleared, or licensed under the Act or PHS Act, for diagnosing, treating, or preventing the disease or condition referred to in paragraph (1) and caused by the agent specified in the declaration of emergency;
3. That the known and potential benefits of the product outweigh the known and potential risks of the product when used to diagnose, prevent, or treat the serious or life threatening disease or condition that is the subject of the declaration; and
4. That there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such serious or life threatening disease or condition.
An EUA may remain in effect for the duration (one year) of the declaration justifying the emergency use unless revoked. Both the declaration of an emergency and EUAs issued under that declaration may be renewed if justified after a year. The law requires the FDA to publish notice of each EUA in the Federal Register, each termination or revocation of an authorization, and an explanation of the reasons for the action.
4. Are there any limits on the use of an EUA product?
For unapproved products, the law requires the FDA Commissioner (to the extent practicable given the circumstances of the emergency) to establish certain conditions on an EUA that the Commissioner finds necessary or appropriate to protect the public health, and permits the Commissioner to establish other conditions that he finds necessary or appropriate to protect the public health. Such conditions may include a requirement to disseminate information to health care providers or authorized dispensers and prospective patients and other consumers regarding the EUA, the product’s significant known and potential benefits and risks and the extent to which such benefits and risks are unknown; available alternatives and their benefits and risks; and, for prospective patients and consumers, the option to accept or refuse the product and any consequences of refusal. Other conditions may include adverse event reporting and monitoring, data collection and analysis, and recordkeeping and records access.
For unapproved uses of approved products, certain of these conditions and other conditions may be required in an EUA.
Use of a product under an authorization must be consistent with any conditions imposed on the EUA.
The PREP Act and EUAs
5. What is the PREP Act?
The PREP Act authorizes the Secretary of the Department of Health and Human Services (“Secretary”) to issue a declaration (“PREP Act declaration”) that provides immunity from tort liability (except for willful misconduct) for claims of loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats and conditions determined by the Secretary to constitute a present, or credible risk of a future public health emergency to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures. A PREP Act declaration is specifically for the purpose of providing immunity from tort liability, and is different from, and not dependent on, other emergency declarations. The PREP Act also authorizes an emergency fund in the United States Treasury to provide compensation for injuries directly caused by administration or use of a countermeasure covered by the Secretary’s declaration. While no funds have been appropriated for this purpose, if funds are appropriated, compensation may then be availalble for medical benefits, lost wages and death benefits to individuals for specified injuries.
For more information on the PREP Act visit HHS: Public Readiness and Emergency Preparedness Act Questions and Answers .
6. What happens if the unapproved drugs or approved drugs for unapproved uses are distributed outside the scope of, or inconsistent with, the conditions of the EUA once it has been issued?

If the FDA issues an EUA to allow for the lawful distribution or dispensing of products for emergency use under certain circumstances and states do not distribute or dispense the countermeasures in accordance with the scope and conditions of the EUA, liability protections afforded by the PREP Act may be affected.
Swine Influenza Countermeasures
7. Are there EUAs currently in effect?
Yes. The FDA made available to public health and medical personnel important diagnostic and therapeutic tools to identify and respond to the swine flu virus under certain circumstances.
On April 27, 2009, the FDA issued EUAs for the use of certain antiviral products (Relenza, Tamiflu), N95 respirators, and for the rRT-PCR Swine Flu Panel diagnostic test.
Additional information on these EUAs can also be found on U S Food and Drug Administration Home Page.
8. Why are EUAs needed to distribute swine influenza countermeasures?
While Tamiflu and Relenza have been previously approved by the FDA, certain aspects of the distribution and use of these products are not covered by their approved applications. An EUA allows these drugs to be legally distributed for the unapproved uses for which they are being authorized.
FDA has authorized emergency use of disposable N95 respirators by the general public during this declared emergency. These respirators may help to keep out germs that may be present in the air you breathe.
The rRT-PCR Swine Flu Panel diagnostic test has not been approved or cleared by the FDA. An EUA allows this unapproved diagnostic kit to be legally distributed and used for the authorized purposes.
9. Will the EUAs cover swine influenza countermeasures not supplied by the Strategic National Stockpile?
In addition to the countermeasures supplied by the Strategic National Stockpile, Tamiflu and Relenza that are supplied via state and local governments are also covered by the EUAs, if the terms and conditions of the EUAs are met.
Fact Sheets
10. Will the recipient and health care provider fact sheets be available in multiple language translations?
Currently, the EUAs do not include translated versions of fact sheets.
11. Will states be distributing their own state-developed fact sheets for swine influenza countermeasures deployed from the Strategic National Stockpile for use under an EUA?
For the use of a countermeasure to be under an EUA, fact sheets as specifically authorized by the EUA will be distributed.
Labels
12. Will Project Areas need to plan to include information required under section 503(b)(2) of the Act on the label of the dispensed Tamiflu and Relenza?
No. The EUAs will permit that not all of the information required under section 503(b)(2) of the Act would appear on the label of the distributed Tamiflu and Relenza.
Reporting Adverse Events
13. How do I report adverse events from using Tamiflu, Relenza and N95 respirators?
Health care professionals and consumers may report serious adverse events (side effects) with the use of these products or product quality problems to the FDA's MedWatch Adverse Event Reporting program:
• Online: FDA's MedWatch Adverse Event Reporting program
• Regular Mail: use postage-paid FDA form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: (800) FDA-0178
• Phone: (800) FDA-1088
Apr 28, 2009
FDA-Issued EUA Letters
What are the products currently under EUA?
Tamiflu (oseltamivir) Emergency Use Authorization of Tamiflu (oseltamivir)
April 29, 2009, 1:45 AM ETTamiflu® EUA, Fact Sheet for Health Care Providers
Authorized by FDA on April 27, 2009
TAMIFLU® FACT SHEET FOR HEALTH CARE PROVIDERS1
You have been asked as a health care provider to give TAMIFLU® to people
who have been exposed to swine influenza.
TAMIFLU® (oseltamivir phosphate) is FDA-approved to treat and prevent
influenza. Certain aspects of this emergency use are not part of the approved
drug applications. For more information refer to www.cdc.gov/swineflu.
The Strategic National Stockpile (SNS) supplies TAMIFLU® 75 mg oral use
capsules in a Unit of Use (UoU) bottle containing 10 capsules and
TAMIFLU® powder for oral suspension (12 mg/mL).
Recommended Treatment Dosage
Adults and Adolescents 13 years and older
75 mg twice daily for 5 days. Treatment should begin within 2 days of
symptom onset.
Pediatric Patients _1 year old
Dosage is shown in the following table. For pediatric patients who cannot
swallow capsules, TAMIFLU® Oral Suspension is the preferred formulation.
If the oral suspension product is not available, TAMIFLU® capsules may be
opened and mixed with sweetened liquids such as regular or sugar-free
chocolate syrup.
Body
Weight
(kg)
Body
Weight
(lbs)
Dose by
Age
(years)
Dose for 5
Days
# Bottles of Oral
Suspension
Needed for the 5
Day Regimen
# of Capsules
Needed
for the
5 Day
Regimen
_15 _33 1-2 30 mg twice
daily
1 10 capsules
(30 mg)
>15-23 >33-51 3-5 45 mg twice
daily
2 10 capsules
(45 mg)
>23-40 >51-88 6-9 60 mg twice
daily
2 20 capsules
(30 mg)
>40 >88 > 10 75 mg twice
daily
3 10 capsules
(75 mg)
1 In the event of an emergency, it is possible that public health officials or other volunteers might
distribute TAMIFLU® products to recipients as authorized. In this fact sheet, the term "health care
provider(s)" includes these individuals and is used for brevity here.
An oral dosing dispenser with 30 mg, 45 mg, and 60 mg graduations is
provided with the oral suspension; the 75 mg dose can be measured using a
combination of 30 mg and 45 mg. It is recommended that patients use this
dispenser. In the event that the dispenser provided is lost or damaged,
another dosing syringe or other device may be used to deliver the following
volumes: 2.5 mL (1/2 tsp) for children _15 kg, 3.8 mL (3/4 tsp) for >15 kg to
23 kg, 5.0 mL (1 tsp) for >23 kg to 40 kg, and 6.2 mL (1 ¼ tsp) for >40 kg.
Pediatric Patients less than 1 year old
Body Weight (kg) Dose by Age Recommended
Treatment Dose for 5
Days
6-11 months 25 mg twice daily
3-5 months 20 mg twice daily
Dosing for infants
younger than 1
year not based on
weight < 3 months 12 mg twice daily
For infants less than 1 year old, a different measuring device (such as a 5-mL
oral syringe) must be used that will dispense 2 mL (about 25 mg), 1.6 mL
(about 20 mg) or 1 mL (12 mg).
Recommended Prophylaxis Dosage
Adults and Adolescents
75 mg once daily for at least 10 days following close contact with an infected
person. Therapy should begin within 2 days of exposure. The recommended
dose for prophylaxis during a community outbreak of influenza is 75 mg
once daily. Safety and efficacy have been demonstrated for up to 6 weeks.
The duration of protection lasts for as long as dosing is continued.
Pediatric Patients _1 year old
Dosage following close contact with an infected individual is shown in the
following table. TAMIFLU® for Oral Suspension may also be used by
patients who cannot swallow a capsule. For pediatric patients who cannot
swallow capsules, TAMIFLU® Oral Suspension is the preferred formulation.
If the oral suspension product is not available, TAMIFLU® capsules may be
opened and mixed with sweetened liquids such as regular or sugar-free
chocolate syrup. Body
Weight
(kg)
Body
Weight
(lbs)
Dose
by Age
(years)
Dose for
10 Days
# Bottles of Oral
Suspension
Needed for the
10 Day Regimen
Number of
Capsules
Needed for the
10 Day
Regimen
_15 _33 1-2 30 mg once
daily
1 10 capsules (30
mg)
>15-23 >33-51 3-5 45 mg once
daily
2 10 capsules (45
mg)
>23-40 >51-88 6-9 60 mg once
daily
2 20 capsules (30
mg)
>40 >88 > 10 75 mg once
daily
3 10 capsules (75
mg)
An oral dosing dispenser with 30 mg, 45 mg, and 60 mg graduations is
provided with the oral suspension; the 75 mg dose can be measured using a
combination of 30 mg and 45 mg. It is recommended that patients use this
dispenser. In the event that the dispenser provided is lost or damaged,
another dosing syringe or other device may be used to deliver the following
volumes: 2.5 mL (1/2 tsp) for children _15 kg, 3.8 mL (3/4 tsp) for >15 kg to
23 kg, 5.0 mL (1 tsp) for >23 kg to 40 kg, and 6.2 mL (1 ¼ tsp) for >40 kg.
Prophylaxis in pediatric patients following close contact with an infected
individual is recommended for 10 days. Prophylaxis in patients 1 to 12 years
of age has not been evaluated for longer than 10 days duration. Therapy
should begin within 2 days of exposure.
Pediatric Patients less than 1 year old
Body Weight (kg) Dose by Age Recommended
Prophylaxis Dose for
10 Days
6-11 months 25 mg once daily
3-5 months 20 mg once daily
Dosing for infants
younger than 1
year not based on
weight < 3 months Not recommended
unless situation judged
critical
For infants less than 1 year old, a different measuring device (such as a 5-mL
oral syringe) must be used that will dispense 2 mL (about 25 mg), 1.6 mL
(about 20 mg) or 1 mL (12 mg, if prophylaxis is judged to be critical).
Special Dosage Instructions
No dose adjustment is recommended for patients with mild or moderate
hepatic impairment (Child-Pugh score _9). No dose adjustment is required
for geriatric patients.
Renal Impairment, Recommended Treatment Dosage Dose adjustment is
recommended for patients with creatinine clearance between 10 and 30
mL/min. Treatment dose should be reduced to 75 mg once daily for 5 days.
No recommended dosing regimens are available for patients undergoing
routine hemodialysis and continuous peritoneal dialysis treatment with endstage
renal disease.
Renal Impairment, Recommended Prophylaxis Dosage
For the prophylaxis of influenza, dose adjustment is recommended for
patients with creatinine clearance between 10 and 30 mL/min receiving
TAMIFLU®. In these patients it is recommended that the dose be reduced to
75 mg of TAMIFLU® every other day or 30 mg TAMIFLU® every day. No
recommended dosing regimens are available for patients undergoing routine
hemodialysis and continuous peritoneal dialysis treatment with end-stage
renal disease.
Preparation of TAMIFLU® for Oral Suspension
TAMIFLU® for Oral Suspension may be constituted by a pharmacist or
health care provider.
1. Tap the closed bottle several times to loosen the powder.
2. Measure 23 mL of water in a graduated cylinder.
3. Add the total amount of water for constitution to the bottle and shake
the closed bottle well for 15 seconds.
4. Remove the child-resistant cap and push bottle adapter into the neck
of the bottle.
5. Close bottle with child-resistant cap tightly. This will assure the
proper seating of the bottle adapter in the bottle and child-resistant
status of the cap.
NOTE: SHAKE THE TAMIFLU® FOR ORAL S

Store constituted suspension under refrigeration at 2-8°C (36-46°F). Do not
freeze. The constituted TAMIFLU® for Oral Suspension (12 mg/mL) should
be used within 10 days of preparation; the pharmacist, health care official,
patient, or patient’s parent or guardian should write the date of expiration of
the constituted suspension on the label. The Fact Sheet for Patients and
Parents and oral dispenser should be dispensed to the patient.
What are the Possible Side Effects?
The side effects reported most often in those people who took this drug were
gastrointestinal (i.e., nausea and vomiting). Nausea and vomiting may be less
severe if TAMIFLU® is taken with food.
Rare cases of anaphylaxis and serious skin reactions including toxic
epidermal necrolysis, Stevens-Johnson Syndrome, and erythema multiforme
have been reported in post marketing experience with TAMIFLU®.
TAMIFLU® should be stopped and appropriate treatment instituted if an
allergic-like reaction occurs or is suspected.
There have been postmarketing reports of delirium and abnormal behavior
leading to injury, and in some cases resulting in fatal outcomes, in patients
with influenza who were receiving TAMIFLU®. These events may occur in
the setting of encephalitis or encephalopathy but can occur without obvious
severe disease. Because these events were reported voluntarily during
clinical practice, estimates of frequency cannot be made but they appear to be
uncommon based on TAMIFLU® usage data. These events were reported
primarily among pediatric patients and often had an abrupt onset and rapid
resolution. The contribution of TAMIFLU® to these events has not been
established. Patients with influenza should be closely monitored for signs of
abnormal behavior.
Refer to the Package Insert for more safety information.
Make available to recipients the information in the Fact Sheet for
Relenza (zanamivir) Emergency Use Authorization of Relenza (zanamivir)
April 29, 2009, 1:45 AM ET

ZANAMIVIR FACT SHEET FOR HEALTH CARE PROVIDERS
As you may already be aware, a public health emergency has been declared in the U.S. due to a current outbreak of swine
influenza virus. You have been asked to give Relenza® (zanamivir), as appropriate, to people who may have been exposed
to swine influenza A (H1N1). Zanamivir is approved by the U.S. Food and Drug Administration (FDA) for treatment of
influenza in patients 7 years of age and older who have been symptomatic for no more than 2 days, and for prophylaxis of
influenza in patients 5 years of age and older.* The FDA-approved package insert on zanamivir can be found via
Drugs@FDA on U.S. FDA CDER Home Page.
Who should not take Zanamivir?
Patients with a history of severe allergic reaction to zanamivir or lactose, or have an underlying airway disease should not
take zanamivir. Zanamivir should only be used for treatment of persons aged 7 years and older and for prevention in
persons aged 5 years and older. It should not be used for prevention of flu in nursing home patients.
What is the dose of Zanamivir?
For Treatment: 10 mg (2 inhalations) twice daily for 5 days
For Prevention: Household Setting: 10 mg (2 inhalations) once daily for 10 days
Community Outbreaks: 10 mg (2 inhalations) once daily for 28 days
The dose should be given at approximately the same time each day.
Zanamivir will be supplied in the manufacturer’s packaging. Zanamivir is packaged in a medicine disk called a Rotadisk®
and is inhaled by mouth using a delivery device called a Diskhaler®. Each Rotadisk® contains 4 blisters. Each blister
contains 5 mg of active drug and 20 mg of lactose powder (which contains milk proteins). Each packaged box of
zanamivir contains 5 Rotadisks® (total of 10 doses) and a Diskhaler® inhalation device.
Zanamivir should be given to children only under adult supervision and instruction, and the supervising adult should first
be instructed by a healthcare professional. Instructions should include a demonstration whenever possible.
What are the possible serious side effects of Zanamivir?
Some patients have had bronchospasm or serious breathing problems when they used zanamivir. Zanamivir is not
recommended for people with chronic respiratory disease such as asthma or chronic obstructive pulmonary disease.
Patients with lung disease should have a fast-acting inhaled bronchodilator available while being treated with
zanamivir. Bronchodilators should be used prior to administration of zanamivir.
People with the flu, particularly children and adolescents, may be at an increased risk of seizures, confusion, or
abnormal behavior early in their illness. These events may occur after beginning zanamivir or may occur when flu is
not treated. These events are uncommon but may result in accidental injury to the patient. Therefore, patients should
be observed for signs of unusual behavior.
Zanamivir was not effective in reducing the chance of getting the flu in 2 studies in nursing home patients.
Patients should be instructed to stop taking zanamivir if they experience signs or symptoms of an allergic reaction.
Refer to the Package Insert for more safety information.
Make available to recipients the information in the "Zanamivir Summary Fact Sheet for Patients and Parents."
Reporting And Monitoring Adverse Events
Health care providers and recipients that experience adverse events or medication errors are encouraged to report to
MedWatch at MedWatch Home Page, by submitting a MedWatch Form 3500 (available at
http://www.fda.gov/medwatch/safety/F...0_fillable.pdf) or by calling 1-800-FDA-1088.
*Certain aspects of this emergency use are not part of the approved drug applications. However, the FDA Commissioner has
authorized the emergency use of zanamivir. Additional information can be found on
Swine Flu Test Kit
Emergency Use Authorization of Swine Flu Test Kit
FACT SHEET FOR HEALTHCARE PROVIDERS: INTERPRETING SWINE INFLUENZA RT-PCR
DETECTION PANEL TEST RESULTS
April 26, 2009
A public health emergency has been declared by the Secretary of Health and Human Services because of the 2009 outbreak of
swine influenza A (H1N1), or “swine flu.” The Food and Drug Administration (FDA) has authorized the emergency use of the
Swine Influenza RT-PCR Detection Panel (rRT-PCR Swine Flu Panel) to test for the presumptive presence of swine influenza
virus in clinical specimens under an Emergency Use Authorization (EUA). This authorization will terminate on April 26, 2010
or when the emergency has ceased to exist, whichever is earlier. The information in this Fact Sheet is the minimum necessary to
inform you of the significant known and potential risks and benefits of the emergency use of the rRT-PCR Swine Flu Panel.
At this time, no FDA-approved/cleared tests that identify existence of swine influenza virus in clinical specimens are
available in the United States. Therefore, the Centers for Disease Control and Prevention (CDC) has developed this test to
detect swine influenza virus infections. Current information on swine influenza, including case definitions and infection control
guidelines, is available at http://www.cdc.gov/swineflu/. All information and guidelines, including those on swine influenza
virus laboratory testing, may change as we continue to learn more about this disease. Please check CDC’s swine influenza virus
website regularly for the most current information.
The rRT-PCR Swine Flu Panel test should be ordered to presumptively diagnose swine influenza A (H1N1) virus infection only.
Nasopharyngeal or nasal swabs may be collected in the usual fashion and sent to a qualified laboratory for analysis. Specimen
collection should be conducted per the clinical protocol and according to the manufacturer’s instructions for the specimen
collection device.
What does it mean if the specimen tests positive for swine influenza virus?
A positive test result from the rRT-PCR Swine Flu Panel indicates that the patient is presumptively infected with swine
influenza virus. The test does not indicate the stage of infection. Laboratory test results should always be considered in the
context of clinical observations and epidemiologic data in making a final diagnosis. For guidelines on managing patients please
refer to “Interim Guidance for Infection Control for Care of Patients with Confirmed or Suspected Swine Influenza A (H1N1)
Virus Infection in a Healthcare Setting” and “Interim Guidance on Antiviral Recommendations for Patients with Confirmed or
Suspected Swine Influenza A (H1N1) Virus Infection and Close Contacts” at http://www.cdc.gov/swineflu/investigation.htm.
The test has been designed to minimize the likelihood of false positive test results. However, should false positive results occur,
risks to patients could include a recommendation for quarantine of household or other close contacts, a recommendation for
patient isolation that might limit contact with family or friends, the ability to work, or the ability to receive certain medical care,
prescription of an antiviral drug or other therapy, or other unintended adverse effects.
What does it mean if the specimen tests negative for swine influenza virus?
Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient
management decisions. The clinical features of the illness and the type and risk of exposure are the keys to making patient
management and isolation decisions. A negative RT-PCR test should not be interpreted as demonstrating that the patient does
not have swine influenza virus infection, if other aspects of the patient’s clinical presentation or recent epidemiologic exposures
indicate swine influenza virus infection is likely, and diagnostic tests for other causes of acute respiratory illness are negative.
Contact Information for the Manufacturer:
CDC Influenza Division
1600 Clifton Road, MS-G03
Atlanta GA 30333
Contact phone 404-6390954
*Any significant new findings observed during the course of the emergency use of Swine Influenza RT-PCR assay will be made
available at http://www.cdc.gov/swineflu
FACT SHEET FOR PATIENTS: UNDERSTANDING SWINE INFLUENZA KIT TEST RESULTS
April 26, 2009
An emergency has been declared by the Secretary of Health and Human Services because of the 2009 outbreak of swine
influenza (swine flu). The Food and Drug Administration (FDA) has authorized the emergency use of Swine Influenza Test Kit
to test for the presence of swine flu virus. This authorization will terminate on April 26, 2010 or when the emergency has ceased
to exist, whichever is earlier. The information in this Fact Sheet is the minimum necessary to inform you of the significant
known and potential risks and benefits of the emergency use of Swine Influenza RT-PCR assay.
Why was my sample tested using the Swine Influenza Test Kit?
There are no FDA cleared or approved tests that can identify swine flu virus. Therefore, your sample was tested using the Swine
Influenza Test Kit because you may have been exposed to the swine flu virus. This test could help to determine whether you are
infected with the swine flu virus, so that public health officials could quickly identify a case and limit its spread. The results of
this test, along with other information, may also help your doctor take better care of you.
What is swine flu?
Swine flu is a respiratory disease of pigs caused by type A influenza virus that regularly causes outbreaks of influenza in pigs.
Human cases of swine flu virus infection have been identified in the United States and internationally. CDC has determined that
this virus is contagious and is spreading from human to human. Like seasonal flu, swine flu in humans can vary in severity from
mild to severe.
What is the Swine Influenza Test Kit?
The Swine Influenza Test Kit is a sensitive test to detect the swine flu virus. The FDA has not cleared or approved this test. The
FDA has agreed that we can use this test under an Emergency Use Authorization. We don’t know for sure if this test can
identify all people who may get sick with swine flu.
What are the known risks and benefits of Swine Influenza Test Kit?
The results of this test from nasopharyngeal or nasal swab, along with other information, can help your doctor take better care of
you. Knowing your test results may help you to prevent the spread of the virus to your family or others. There may be no other
benefits to you from this test.
If this test is positive, does that mean that I have swine flu?
Yes, though there is a very small chance that this test can give a result that is wrong (false positive), it is not likely. If your result
from this test is positive, your doctor may decide how to care for you based on the test results along with other factors.
If this test is negative, does that mean that I do not have swine flu?
If this test is negative, you may not be sick, or you may be sick with something that is not swine flu. There is a small chance that
this can give a result that is wrong (false negative). A false negative result should not affect your care. No changes in your
medical care or how you interact with other people should be solely based on a negative result.
*Any significant new findings observed during the course of the emergency use of Swine Influenza Test Kit will be made
available at http://www.cdc.gov/swineflu/.
Swine Flu Test Kit: EUA Conditions for State and/or Local Public Health Authority(ies)
April 29, 2009, 1:45 AM ET
As described in the Food and Drug Administration (FDA) final guidance entitled “Emergency Use Authorization of Medical Products” (dated July 2007), Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act, or “the Act”) requires the FDA Commissioner (to the extent practicable given the circumstances of the emergency) to establish certain conditions on an EUA authorization that the Commissioner finds necessary or appropriate to protect the public health, and permits the Commissioner to establish other conditions that he finds necessary or appropriate to protect the public health.
Pursuant to section 564 of the Act, the following conditions1 impacting public health and other qualified laboratories, and state and/or local public health authority(ies), as applicable, have been established on the EUA authorization issued for the following product:
Swine Influenza Virus Real-time RT-PCR Detection Panel (rRT-PCR Swine Flu Panel)
Public Health and Other Qualified Laboratories will:
• Include with reports of the results of the rRT-PCR Swine Flu Panel, the authorized fact sheets for health care providers and the authorized fact sheet for patients.
• Qualified laboratories will perform the assay on an Applied Biosystems 7500 Fast Dx Real-time PCR instrument or the RUO marketed Applied Biosystems 7500 Real-time PCR instrument that is validated by Applied Biosystems with regard to the updated software but only partially qualified regarding its laboratory performance (proficiency testing with the CDC sample panel not performed).
• Qualified laboratories will have a process in place for reporting test results to health care providers and federal, state and/or local public health authorities, as appropriate.

State and/or Local Public Health Authority(ies) will:
• Make available additional information relating to the emergency use of the authorized rRT-PCR Swine Flu Panel that is consistent with, and does not exceed, the terms of this letter of authorization2.
• Ensure that any records associated with this EUA are maintained until notified by FDA. Such records will be made available to FDA for inspection upon request.

For laboratory questions, please contact flusupport@cdc.gov.
1 For questions regarding EUA conditions, please contact: EUA.OCET@fda.hhs.gov.
2 For a copy of the official FDA EUA Authorization letter, please refer to the FDA Swine Influenza site .
• Links to non-federal organizations are provided solely as a service to our users. These links do not constitu


FDA Related Information
EUA Guidance DocumentGUIDANCE1
Emergency Use Authorization of Medical Products

This guidance document represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You may use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, please contact the appropriate FDA staff.
I. INTRODUCTION
This guidance explains FDA's policies for authorizing the emergency use of medical products under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-3), which was amended by the Project BioShield Act of 2004 (Public Law 108-276).2 Section 564 permits the FDA Commissioner to authorize the use of an unapproved medical product or an unapproved use of an approved medical product during a declared emergency involving a heightened risk of attack on the public or U.S. military forces, or a significant potential to affect national security.
The Emergency Use Authorization (EUA) authority recently granted by Congress allows the FDA Commissioner to strengthen the public health protections against biological, chemical, radiological, and nuclear agents that may be used to attack the American people or the U.S. armed forces. Under section 564, the FDA Commissioner may allow medical countermeasures to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by such agents, when there are no adequate, approved, and available alternatives.
The document is intended to inform industry, government agencies, and FDA staff of the Agency's general recommendations and procedures for issuance of EUAs.3 FDA expects that requests for consideration for an EUA would be submitted by government agencies (e.g., the Department of Health and Human Services or the Department of Defense (DoD)) or private entities. FDA may seek additional data and information on a case-by-case basis to ensure that the statutory criteria for issuance of an EUA are met.
Additionally, the Secretary of Health and Human Services (the Secretary) will establish a permanent Emergency Use Authorization Working Group (EUA WG), headed by the Assistant Secretary for Preparedness and Response (ASPR), with representatives from FDA, the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Department of Defense (DoD), the Department of Homeland Security (DHS), the Department of Veterans Affairs and, as appropriate, participants from other Federal agencies, to identify and provide expert consultation on potential EUA candidates prior to and during declared emergencies.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
II. DECLARATION OF EMERGENCY
Section 564(b)(1) of the FD&C Act provides that, before an EUA may be issued, the Secretary must declare an emergency based on one of the following grounds:
1. a determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agents;
2. a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces of attack with a specified biological, chemical, radiological, or nuclear agent or agents; or
3. a determination by the Secretary of a public health emergency under section 319 of the Public Health Service Act (PHS Act) that affects, or has the significant potential to affect, national security, and that involves a specified biological, chemical, radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such agent or agents.
Once the Secretary has declared an emergency justifying an authorization under section 564 to use an unapproved medical product or an approved product for an unapproved use, the ASPR may convene the EUA Working Group to provide expert consultation to the FDA.4 Based on his review of the information and data submitted to the Agency and input from the EUA WG (if convened) and after consulting with the Director of NIH and the Director of CDC (to the extent feasible and appropriate given the circumstances of the emergency), the FDA Commissioner may authorize the emergency use of a particular product, assuming other statutory criteria and conditions are met.5
Section 564(b)(2) states that a declaration of emergency will terminate one year after issuance or earlier if the Secretary determines, in consultation (as appropriate) with the Secretary of Homeland Security or the Secretary of Defense, that the circumstances that precipitated the declaration have ceased. Before a declaration terminates, the Secretary must provide, under section 564(b)(3), advance notice that is sufficient to allow for disposition of unapproved product or any labeling or other information provided related to an unapproved use of an approved product. Section 564(b)(2)(B) also authorizes the Secretary to renew a declaration.
Publication: The Secretary will promptly publish in the Federal Register notice of each determination of actual or potential emergency, the Secretary's declaration of emergency, advance notice of termination, and renewal of a declaration issued under section 564(b).6 The FDA Commissioner will promptly publish in the Federal Register a notice of each authorization, including an explanation of the reasons for issuance, a description of the intended use of the EUA product, and its indications and contraindications. The FDA Commissioner also will promptly publish in the Federal Register each termination or revocation of an authorization and an explanation of the reasons for the decision.7 In addition, FDA plans to provide notice of an emergency use authorization on the Agency's website, at U S Food and Drug Administration Home Page, and through announcements disseminated to the media.8

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