Country: United States
Language: English
Source: NLM (National Library of Medicine)
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN (UNII: XL4HLC6JH6) (HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN - UNII:XL4HLC6JH6)
A-S Medication Solutions
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN 10 ug in 1 mL
INTRAMUSCULAR
RECOMBIVAX HB® [Hepatitis B Vaccine, Recombinant] is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. RECOMBIVAX HB is approved for use in individuals of all ages. RECOMBIVAX HB Dialysis Formulation is approved for use in adult predialysis and dialysis patients 18 years of age and older. Do not administer RECOMBIVAX HB to individuals with a history of severe allergic or hypersensitivity reactions (e.g. , anaphylaxis) after a previous dose of any hepatitis B-containing vaccine or to any component of RECOMBIVAX HB, including yeast [see Description (11)] . Risk Summary All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4%, and 15% to 20%, respectively. There are no adequate and well-controlled studies designed to evaluate RECOMBIVAX HB in pregnant women. Available post-approval data do not suggest an in
Product: 50090-1849
Biologic Licensing Application
RECOMBIVAX HB- HEPATITIS B VACCINE (RECOMBINANT) INJECTION, SUSPENSION A-S MEDICATION SOLUTIONS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE RECOMBIVAX HB SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RECOMBIVAX HB. RECOMBIVAX HB® HEPATITIS B VACCINE (RECOMBINANT) SUSPENSION FOR INTRAMUSCULAR INJECTION INITIAL U.S. APPROVAL: 1986 INDICATIONS AND USAGE RECOMBIVAX HB is a vaccine indicated for prevention of infection caused by all known subtypes of hepatitis B virus. RECOMBIVAX HB is approved for use in individuals of all ages. RECOMBIVAX HB Dialysis Formulation is approved for use in predialysis and dialysis patients 18 years of age and older. (1) DOSAGE AND ADMINISTRATION RECOMBIVAX HB Persons from birth through 19 years of age: A series of 3 doses (0.5 mL each) given on a 0-, 1-, and 6- month schedule. (2.1) Adolescents 11 through 15 years of age: A series of either 3 doses (0.5 mL each) given on a 0-, 1-, and 6-month schedule or a series of 2 doses (1.0 mL) on a 0- and 4- to 6-month schedule). (2.1) Persons 20 years of age and older: A series of 3 doses (1.0 mL each) given on a 0-, 1-, and 6-month schedule. (2.1) RECOMBIVAX HB Dialysis Formulation Adults on predialysis or dialysis: A series of 3 doses (1.0 mL each) given on a 0-, 1-, and 6-month schedule. (2.1) DOSAGE FORMS AND STRENGTHS RECOMBIVAX HB is a sterile suspension available in the following presentations: 0.5 mL (5 mcg) Pediatric/Adolescent Formulation single-dose vials and prefilled syringes (3, 11, 16.1) 1 mL (10 mcg) Adult Formulation single-dose vials and prefilled syringes (3, 11, 16.1) RECOMBIVAX HB Dialysis Formulation is a sterile suspension available in the following presentation: 1 mL (40 mcg) single-dose vials (3, 11, 16.1) CONTRAINDICATIONS Severe allergic or hypersensitivity reactions (e.g., anaphylaxis) after a previous dose of any hepatitis B- containing vaccine, or to any component of RECOMBIVAX HB, including yeast. (4, 11) WARNINGS AND PRECAUTIONS T Read the complete document