Recombivax Hb Pediatric/adolescent

— THERAPEUTIC DISORDERS TREATED —
  • Vaccines

Recombivax Hb Pediatric/adolescent Generic Name & Formulations

General Description

Hepatitis B surface antigen vaccine (recombinant) 5mcg/0.5mL; susp for IM inj; aluminum hydroxide adsorbed; preservative-free.

Pharmacological Class

HB.

How Supplied

Single-dose vials: Ped/Adolescent 5mcg/0.5mL (yellow cap)—1, 10; Adult 10mcg/1mL (green cap)—1, 10; Dialysis 40mcg/1mL (blue cap)—1

Manufacturer

Recombivax Hb Pediatric/adolescent Indications

Indications

Hepatitis B immunization.

Recombivax Hb Pediatric/adolescent Dosage and Administration

Adults and Children

Use correct formulation; see literature. Give IM into anterolateral thigh for children; deltoid for adults. May give SC if risk of hemorrhage. Patients 0–19yrs of age (three-dose regimen): give 1st dose of 5mcg at elected date and repeat after 1 month (2nd dose) and 6 months after first dose (3rd dose). Or, for patients 11–15yrs of age, may use alternate two-dose regimen: give 1st dose of 10mcg at elected date and repeat after 4–6 months (2nd dose). Patients ≥20yrs of age: give 1st dose of 10mcg at elected date and repeat after 1 month (2nd dose) and 6 months after first dose (3rd dose). Dialysis and pre-dialysis patients: give 1st dose of 40mcg at elected date and repeat after 1 month (2nd dose) and 6 months after first dose (3rd dose); consider booster dose if antibody levels fall to <10mIU/mL. High-risk infants (mother is HBsAg positive or unknown) or if exposed to HBsAg: give hepatitis B immune globulin also (see literature).

Recombivax Hb Pediatric/adolescent Contraindications

Contraindications

Yeast hypersensitivity.

Recombivax Hb Pediatric/adolescent Boxed Warnings

Not Applicable

Recombivax Hb Pediatric/adolescent Warnings/Precautions

Warnings/Precautions

Have epinephrine inj (1:1000) available. Serious active infection. Severely compromised cardiopulmonary status. Pregnancy (Cat.C). Nursing mothers.

Recombivax Hb Pediatric/adolescent Pharmacokinetics

See Literature

Recombivax Hb Pediatric/adolescent Interactions

Recombivax Hb Pediatric/adolescent Adverse Reactions

Adverse Reactions

Local reactions, irritability, fatigue, headache, fever, malaise, nausea, diarrhea, anorexia, pharyngitis, upper respiratory infection, anaphylaxis.

Recombivax Hb Pediatric/adolescent Clinical Trials

See Literature

Recombivax Hb Pediatric/adolescent Note

Not Applicable

Recombivax Hb Pediatric/adolescent Patient Counseling

See Literature