Rx Item-Engerix-B 20 Mcg/Ml Vial 10X1Ml By Glaxosmithkline Vaccines

Clinical Information
Gen. Code and Des.
62668 hepatitis B virus vaccine/PF INTRAMUSC VIAL 20 MCG/ML
GCN and Des.
98442 hepatitis B virus vaccine/PF INTRAMUSC VIAL 20 MCG/ML
Strength
20MCG/ML
Dose Form
VIAL (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
80120000 VACCINES
Active Ingredients
8320 hepatitis B virus vaccine, recombinant
9870 preservative free
Inactive Ingredients

RECOMBIVAX HB- hepatitis b virus subtype adw hbsag surface protein antigen injection, suspension
Merck Sharp & Dohme Corp.

1 INDICATIONS AND USAGE

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.

2 DOSAGE AND ADMINISTRATION



For intramuscular administration. See Section 2.2 for subcutaneous administration in persons with hemophilia.

2.1 Dosage and Schedule
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.

Adolescents 11 through 15 years of age: A series of 3 doses (0.5 mL each) given on a 0-, 1-, and 6-month schedule or a series of 2 doses (1.0 mL each) on a 0- and 4- to 6-month schedule.

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.

RECOMBIVAX HB Dialysis Formulation:

Adults on predialysis and dialysis: A series of 3 doses (1.0 mL each) given on a 0-, 1-, and 6-month schedule.

Engerix-B 20 Mcg/Ml Vial 10X1M
item No.:RX608531 608531 NDC No.58160082111 58160-821-11 5816082111 UPC No.:358160821111 NDC No. 58160-0821-11 UPC/GTIN No. 3-58160-82111-1 358160821111 358160-821111 MPN 82111 Only Lic.-Physician,Pha

Engerix-B 20 Mcg/Ml Vial 10X1M
item No.:RX608531 608531 NDC No.58160082111 58160-821-11 5816082111 UPC No.:358160821111 NDC No. 58160-0821-11 UPC/GTIN No. 3-58160-82111-1 358160821111 358160-821111 MPN 82111 Only Lic.-Physician,Pha

HEPATITIS B VIRUS VACCINE
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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58160-0821-11
ENGERIX-B 20 MCG/ML VL 10X1 ML item No.:RX608531 608531 NDC No.58160082111 58160-821-11 5816082111 UPC No.:358160821111 NDC No. 58160-0821-11 UPC/GTIN No. 3-58160-82111-1 358160821111 358160-821111 MP

58160-0821-11
ENGERIX-B 20 MCG/ML VL 10X1 ML item No.:RX608531 608531 NDC No.58160082111 58160-821-11 5816082111 UPC No.:358160821111 NDC No. 58160-0821-11 UPC/GTIN No. 3-58160-82111-1 358160821111 358160-821111 MP

Engerix-B 20 Mcg/Ml Vial 10X1Ml By Glaxo
BRAND: ENGERIX-B NDC: 58160-0821-11,58160082111 UPC: 3-58160-82111-1,358160821111 Glaxosmithkline/Vaccines item No.:RX608531 608531 NDC No.58160082111 58160-821-11 5816082111 UPC No.:358160821111 NDC