RECOMBIVAX HB (hepatitis b vaccine- recombinant injection, suspension

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN (UNII: XL4HLC6JH6) (HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN - UNII:XL4HLC6JH6)

זמין מ:

Merck Sharp & Dohme LLC

INN (שם בינלאומי):

HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN

הרכב:

HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN 5 ug in 0.5 mL

מסלול נתינה (של תרופות):

INTRAMUSCULAR

סממני תרפויטית:

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

leaflet_short:

RECOMBIVAX HB (pediatric and adult) FORMULATION is available in single-dose vials and prefilled Luer-Lok® syringes. RECOMBIVAX HB DIALYSIS FORMULATION is available in single-dose vials. Pediatric/Adolescent Formulation (PRESERVATIVE FREE) 0.5 mL (5 mcg) in single-dose vials and prefilled Luer-Lok® syringes NDC 0006-4981-00 – box of ten 0.5-mL single-dose vials Color coded with a yellow cap and stripe on the vial labels and cartons and an orange banner on the vial labels and cartons NDC 0006-4093-02 – carton of 10 prefilled single-dose Luer-Lok® syringes with tip caps Color coded with a yellow plunger rod Adult Formulation (PRESERVATIVE FREE) 1 mL (10mcg) in single-dose vials and prefilled Luer-Lok® syringes NDC 0006-4995-00 – 1-mL single dose vial Color coded with a green cap and stripe NDC 0006-4995-41 – box of ten 1-mL single-dose vials Color coded with a green cap and stripe NDC 0006-4094-02 – carton of 10 pre-filled single-dose syringes with tip caps Color coded with a green plunger rod RECOMBIVAX HB DIALYSIS FORMULATION 1 mL (40mcg) in single-dose vials NDC 0006-4992-00 – 1-mL single-dose vial Color coded with a blue cap and stripe

מצב אישור:

Biologic Licensing Application

מאפייני מוצר

RECOMBIVAX HB- HEPATITIS B VACCINE (RECOMBINANT) INJECTION, SUSPENSION
MERCK SHARP & DOHME LLC
----------
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
Th