WARNINGS
There have been rare reports of anaphylaxis/anaphylactoid reactions following commercial use of the vaccine.
The vial stopper is latex-free. The tip cap and the rubber plunger of the needleless prefilled syringes contain dry natural latex rubber that may cause allergic reactions in latex sensitive individuals.
Hepatitis A has a relatively long incubation period (15 to 50 days). Hepatitis A vaccine may not prevent hepatitis A infection in individuals who have an unrecognized hepatitis A infection at the time of vaccination. Additionally, it may not prevent infection in individuals who do not achieve protective antibody titers (although the lowest titer needed to confer protection has not been determined).
PRECAUTIONS
General: As with any parenteral vaccine, epinephrine should be available for use in case of anaphylaxis or anaphylactoid reaction.
As with any vaccine, administration of HAVRIX should be delayed, if possible, in people with any febrile illness, except when, in the opinion of the physician, withholding vaccine entails the greater risk.
HAVRIX should be administered with caution to people with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.
As with any vaccine, if administered to immunosuppressed persons or persons receiving immunosuppressive therapy, the expected immune response may not be obtained. 20
Care is to be taken by the healthcare provider for the safe and effective use of HAVRIX.
Prior to an injection of any vaccine, all known precautions should be taken to prevent adverse reactions. This includes a review of the patient's history with respect to possible hypersensitivity to the vaccine or similar vaccines.
A separate sterile syringe and needle (for single-dose vial) or a sterile disposable unit (prefilled syringe) must be used for each patient to prevent the transmission of infectious agents from person to person. Needles should not be recapped and should be properly disposed.
Special care should be taken to ensure that HAVRIX is not injected into a blood vessel.
Information for Patients: Patients, parents, or guardians should be fully informed of the benefits and risks of immunization with HAVRIX.
HAVRIX is indicated in a variety of situations (see INDICATIONS AND USAGE). For persons traveling to endemic or epidemic areas, current CDC advisories should be consulted with regard to specific locales.
Travelers should take all necessary precautions to avoid contact with or ingestion of contaminated food or water.
The duration of immunity following a complete schedule of immunization with HAVRIX has not been established. Drug Interactions: Preliminary results suggest that the concomitant administration of a wide variety of other vaccines is unlikely to interfere with the immune response to HAVRIX.
As with other intramuscular injections, HAVRIX should be given with caution to individuals on anticoagulant therapy.
When concomitant administration of other vaccines or IG is required, they should be given with different syringes and at different injection sites. Carcinogenesis, Mutagenesis, Impairment of Fertility: HAVRIX has not been evaluated for its carcinogenic potential, mutagenic potential, or potential for impairment of fertility.
Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with HAVRIX. It is also not known whether HAVRIX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. HAVRIX should be given to a pregnant woman only if clearly needed. Nursing Mothers: It is not known whether HAVRIX is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when HAVRIX is administered to a nursing woman. Pediatric Use: HAVRIX is well tolerated and highly immunogenic and effective in children >/=2 years of age. (See CLINICAL PHARMACOLOGY for immunogenicity and efficacy data. See DOSAGE AND ADMINISTRATION for recommended dosage.)
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