Recombivax Hb Dialysis Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Mechanism of Action
Recombivax Hb Dialysis Indications
Indications
Recombivax Hb Dialysis Dosage and Administration
Adults and Children
Administration
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Shake the single-dose vial or single-dose prefilled syringe well to obtain a slightly opaque, white suspension before withdrawal and use.
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Discard if the suspension does not appear homogeneous or if extraneous particulate matter remains or if discoloration is observed.
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For single-dose vials, withdraw and administer the entire dose of Recombivax HB intramuscularly using a sterile needle and syringe. Discard vial after use.
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For single-dose prefilled syringes, securely attach a needle by twisting in a clockwise direction and administer dose of Recombivax HB intramuscularly. Discard syringe after use.
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The deltoid muscle is the preferred site for intramuscular injection for adults, adolescents and children 1 year of age and older whose deltoid is large enough for intramuscular injection.
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The anterolateral aspect of the thigh is the preferred site for intramuscular injection for infants younger than 1 year of age. Recombivax HB should not be administered in the gluteal region, as injections given in the buttocks have resulted in lower seroconversion rates than expected.
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Recombivax HB may be administered subcutaneously to persons at risk for hemorrhage following intramuscular injections (e.g., hemophiliacs). However, hepatitis B vaccines are known to result in lower antibody response when administered subcutaneously. Consider subcutaneous administration only in persons who are at risk of hemorrhage following intramuscular injections.
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Do not administer intravenously or intradermally.
Recombivax Hb Dialysis Contraindications
Contraindications
Recombivax Hb Dialysis Boxed Warnings
Not Applicable
Recombivax Hb Dialysis Warnings/Precautions
Warnings/Precautions
Recombivax Hb Dialysis Pharmacokinetics
See Literature
Recombivax Hb Dialysis Interactions
Interactions
Concomitant Administration with Other Vaccines
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Do not mix Recombivax HB with any other vaccine in the same syringe or vial. Use separate injection sites and syringes for each vaccine.
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In a clinical trial, the safety and immunogenicity of Recombivax HB was similar for separate administration compared with concomitant administration of 1 or more of the following US licensed vaccines: Diphtheria, Tetanus and whole cell Pertussis; oral Poliomyelitis vaccine; Measles, Mumps, and Rubella Virus Vaccine, Live; Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) or a booster dose of Diphtheria, Tetanus, acellular Pertussis.
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In another clinical trial, there were no serious vaccine-related adverse events reported and no impairment of immune responses when a related HBsAg-containing product, Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) combination product (no longer licensed), was given concomitantly with eIPV (enhanced inactivated Poliovirus vaccine) or Varivax® [Varicella Virus Vaccine Live (Oka/Merck)].
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The Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) combination product (no longer licensed) has also been administered concomitantly with the primary series of DTaP to a limited number of infants. No serious vaccine-related adverse events were reported.
Concomitant Administration with Immune Globulin
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Recombivax HB may be administered concomitantly with HBIG. The first dose of Recombivax HB may be given at the same time as HBIG, but the injections should be administered at different sites.
Interference with Laboratory Tests
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Hepatitis B surface antigen (HBsAg) derived from hepatitis B vaccines has been transiently detected in blood samples following vaccination. Serum HBsAg detection may not have diagnostic value within 28 days after receipt of a hepatitis B vaccine, including Recombivax HB.
Recombivax Hb Dialysis Adverse Reactions
Adverse Reactions
Recombivax Hb Dialysis Clinical Trials
Recombivax Hb Dialysis Note
Not Applicable