Novartis Vaccines And Diagnostics Ltd
Manufacturer Details
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Novartis Vaccines And Diagnostics Ltd Drugs
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![Fluvirin (Influenza Virus Vaccine) Injection, Suspension [Novartis Vaccines And Diagnostics Ltd]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=954d90d2-d618-4b30-bc60-c9a42cb4dc88&name=fluvirin-figure-1.jpg)
Fluvirin
2.1 Preparation for Administration
Inspect FLUVIRIN® syringes and multidose vials visually for particulate matter and/or discoloration prior to administration. If either of these conditions exists, the vaccine should not be administered.
Shake the syringe vigorously before administering the vaccine and shake the multidose vial preparation each time before withdrawing a dose of vaccine.
Between uses, return the multidose vial to the recommended storage conditions between 2º and 8ºC (36º and 46ºF). Do not freeze. Discard if the vaccine has been frozen.
A separate syringe and needle or a sterile disposable unit should be used for each injection to prevent transmission of infectious agents from one person to another. Needles should be disposed of properly and not recapped.
It is recommended that small syringes (0.5-mL or 1-mL) should be used to minimize any product loss.
2.2 Recommended Dose and Schedule
Children (4 to 17 years of age):
Children aged 4 to 8 years should receive 2 doses of vaccine if they have not been vaccinated previously at any time with any influenza virus vaccine. Children aged 4 to 8 years who received only 1 dose in their first year of vaccination in the previous season should receive 2 doses. FLUVIRIN® should be given as a 0.5-mL intramuscular injection on day 1 followed by another 0.5-mL intramuscular injection at least 4 weeks later. 2 doses are required for protection in these children. (15.3)
Children aged 4 to 8 years who have been vaccinated with two doses of any influenza virus vaccine in the previous season, or with one dose in the year prior to the previous season, should receive only one dose. (15.3)
Children aged 9 years and older should receive a single 0.5-mL intramuscular injection.
The needle size may range from 7/8 to 1¼ inches, depending on the size of the child's deltoid muscle, and should be of sufficient length to penetrate the muscle tissue. The anterolateral thigh can be used, but the needle should be longer, usually 1 inch.
Adults (18 years and older):
FLUVIRIN® should be administered as a single 0.5-mL intramuscular injection preferably in the region of the deltoid muscle of the upper arm.
The vaccine should not be injected in the gluteal region or areas where there may be a major nerve trunk. A needle of ≥1 inch is preferred because needles <1 inch might be of insufficient length to penetrate muscle tissue in certain adults.
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![Influenza A (H1n1) 2009 Monovalent Vaccine Injection, Suspension [Novartis Vaccines And Diagnostics Ltd]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=fc5cfd1c-1ff5-4cfa-b544-db8d7f26d46f&name=h1n1-figure-1.jpg)
Influenza A
2.1 Preparation for Administration
Inspect Influenza A (H1N1) 2009 Monovalent Vaccine syringes and multidose vials visually for particulate matter and/or discoloration prior to administration. If either of these conditions exists, the vaccine should not be administered.
Shake the syringe vigorously before administering the vaccine and shake the multidose vial preparation each time before withdrawing a dose of vaccine.
Between uses, return the multidose vial to the recommended storage conditions between 2º and 8ºC (36º and 46ºF). Do not freeze. Discard if the vaccine has been frozen.
A separate syringe and needle or a sterile disposable unit should be used for each injection to prevent transmission of infectious agents from one person to another. Needles should be disposed of properly and not recapped.
It is recommended that small syringes (0.5-mL or 1-mL) should be used to minimize any product loss.
2.2 Recommended Dose and Schedule
Clinical studies are ongoing with Influenza A (H1N1) 2009 Monovalent Vaccine to determine the optimal dosage, number of doses and schedule.
Available data show that children 9 years of age and younger are largely serologically naïve to the pandemic (H1N1) 2009 virus (15.1). Based upon these data Influenza A (H1N1) 2009 Monovalent Vaccine should be administered as follows:
Children (4 to 17 years of age):
Children 4 through 9 years of age should receive two 0.5mL doses by intramuscular injection approximately 1 month apart.
Children 10 through 17 years of age should receive a single 0.5-mL intramuscular injection.
The needle size may range from 7/8 to 1¼ inches, depending on the size of the child’s deltoid muscle, and should be of sufficient length to penetrate the muscle tissue. The anterolateral thigh can be used, but the needle should be longer, usually 1 inch.
The vaccine should not be injected in the gluteal region or areas where there may be a major nerve trunk.
Adults (18 years of age and older):
Influenza A (H1N1) 2009 Monovalent Vaccine should be administered as a single 0.5-mL intramuscular injection preferably in the region of the deltoid muscle of the upper arm.
A needle of ≥1 inch is preferred because needles <1 inch might be of insufficient length to penetrate muscle tissue in certain adults.
The vaccine should not be injected in the gluteal region or areas where there may be a major nerve trunk.
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