Influenza A
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Uses
Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for immunization of persons 4 years of age and older against influenza disease caused by pandemic (H1N1) 2009 virus.
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Other Information
Influenza A (H1N1) 2009 Monovalent Vaccine is a sub-unit (purified surface antigen) influenza virus vaccine prepared from virus propagated in the allantoic cavity of embryonated hens’ eggs inoculated with a specific type of influenza virus suspension containing neomycin and polymyxin. The influenza virus strain is harvested and clarified by centrifugation and filtration prior to inactivation with betapropiolactone. The inactivated virus is concentrated and purified by zonal centrifugation. The surface antigens, hemagglutinin and neuraminidase, are obtained from the influenza virus particle by further centrifugation in the presence of nonylphenol ethoxylate, a process which removes most of the internal proteins. The nonylphenol ethoxylate is removed from the surface antigen preparation.
Influenza A (H1N1) 2009 Monovalent Vaccine is a homogenized, sterile, slightly opalescent suspension in a phosphate buffered saline. Influenza A (H1N1) 2009 Monovalent Vaccine is formulated to contain 15 mcg hemagglutinin (HA) per 0.5-mL dose of the following virus strain: A/California/7/2009 (H1N1)v-like virus.
The 0.5-mL prefilled syringe presentation is formulated without preservative. Thimerosal, a mercury derivative used during manufacturing, is removed by subsequent purification steps to a trace amount (≤ 1 mcg mercury per 0.5-mL dose).
The 5-mL multidose vial formulation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5-mL dose from the multidose vial contains 25 mcg mercury.
Each dose from the multidose vial or from the prefilled syringe may also contain residual amounts of egg proteins (≤ 1 mcg ovalbumin), polymyxin (≤ 3.75 mcg), neomycin (≤ 2.5 mcg), betapropiolactone (not more than 0.5 mcg) and nonylphenol ethoxylate (not more than 0.015% w/v).
The multidose vial stopper and the syringe stopper/plunger do not contain latex.
Sources
Influenza A Manufacturers
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Novartis Vaccines And Diagnostics Ltd
![Influenza A (H1n1) 2009 Monovalent Vaccine Injection, Suspension [Novartis Vaccines And Diagnostics Ltd]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Influenza A | Novartis Vaccines And Diagnostics Ltd
2.1 Preparation for AdministrationInspect 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 ScheduleClinical 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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