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Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine
Class: Vaccine, viral
- Injection at least 720 EL.U. inactivated hepatitis A, 20 mcg recombinant HBsAg protein/mL
Provides active immunization.
Indications and Usage
Active immunization of patients 18 yr of age or older against disease caused by hepatitis A and infection by all known subtypes of hepatitis B virus.
Hypersensitivity to yeast or any other component of the vaccine or hypersensitivity after previous administration of this product or monovalent hepatitis A or hepatitis B vaccines.
Dosage and AdministrationAdults
IM 3 doses given on a 0-, 1-, and 6-mo schedule.
- For IM injection only. Not for IV or ID administration.
- Shake vial or syringe well before use to maintain suspension of the vaccine.
- Examine vial or syringe after shaking. Suspension should be homogeneous and white. Discard if it appears otherwise.
- Use vaccine as supplied; no dilution or reconstitution is necessary.
Store vials and syringes in refrigerator (36° to 46°F). Do not freeze. Discard if vaccine has been frozen because freezing destroys potency.
Because bleeding may occur following IM administration, use with caution.Immunosuppressants
May result in inadequate response to immunization.
Diarrhea; nausea; vomiting.
Upper respiratory tract infections.
Local soreness, redness, induration, and swelling; fever.
Category C .
Safety and efficacy not established in patients younger than 18 yr of age.
There have been rare reports of anaphylaxis and anaphylactoid reactions.
- Advise patient that vaccine does not provide protection from other causes of food and waterborne diseases other than hepatitis A and to continue to take all necessary precautions to avoid contact with, or ingestion of, contaminated food and water.
- Review immunization schedule and advise patient that for vaccine to be effective, the complete series of 3 injections must be completed.
- Provide patient with immunization history record.
- Advise patient to use OTC analgesics (eg, acetaminophen, ibuprofen) for fever or pain or discomfort at injection site.
- Advise patient to notify health care provider if bothersome side effects last more than 24 h.
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