Recombivax HB

Krajina: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktívna zložka:

Hepatitis B vaccine, rDNA 10 µg/mL

Dostupné z:

Merck Sharp & Dohme (New Zealand) Limited

INN (Medzinárodný Name):

Hepatitis B vaccine, rDNA 10 µg/mL

Dávkovanie:

10 mcg/dose

Forma lieku:

Suspension for injection

Zloženie:

Active: Hepatitis B vaccine, rDNA 10 µg/mL Excipient: Aluminium as amorphous aluminum hydroxyphosphate sulphate Borax Formaldehyde Potassium thiocyanate Sodium chloride Water for injection

Typ predpisu:

Prescription

Výrobca:

Merck Sharp & Dohme Corp

Terapeutické indikácie:

Indicated for immunisation against infection caused by all known subtypes of hepatitis B virus. Should also prevent hepatitis D (caused by delta virus) since hepatitis D does not occur in the absence of hepatitis B infection.

Prehľad produktov:

Package - Contents - Shelf Life: Syringe, glass, Glass syringe with chlorobutyl rubber stopper and tip cap - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Dátum Autorizácia:

2017-07-27

Súhrn charakteristických

NEW ZEALAND DATA SHEET
IPC-HB2-I-122011
1
NAME OF MEDICINE
RECOMBIVAX HB
®
_hepatitis B vaccine (recombinant) injections _
*5 mcg hepatitis B surface antigen per 0.5 mL (without preservative)
10 mcg hepatitis B surface antigen per 1.0 mL (without preservative)
*40 mcg hepatitis B surface antigen per 1.0 mL (This formulation is
intended for
predialysis/dialysis patients only (without preservative))
*5 mcg/0.5 mL hepatitis B surface antigen and 40 mcg/1.0 mL hepatitis
B surface
antigen vial are currently not supplied in New Zealand.
PRESENTATION
A slightly opaque white sterile suspension (when thoroughly agitated).
The vaccine is available in 1mL prefilled syringes containing 10
mcg/mL of hepatitis
B surface antigen.
THERAPEUTIC CLASS
Recombivax HB is a vaccine produced in yeast cells by a recombinant
DNA
technique which has been shown to produce antibodies to hepatitis B
virus.
INDICATIONS
All formulations of Recombivax HB are indicated for immunisation
against infection
caused by all known subtypes of hepatitis B virus.
Recombivax HB should also prevent hepatitis D (caused by the delta
virus) since
hepatitis D does not occur in the absence of hepatitis B infection.
DOSAGE AND ADMINISTRATION
Do not inject intravenously or intradermally.
Recombivax HB (hepatitis B

recombinant

, MSD) (40 mcg/1.0 mL) (without
preservative) is intended only for adult predialysis/dialysis
patients.
Recombivax HB (hepatitis B

recombinant

, MSD) (5 mcg/0.5 mL [without
preservative] or 10 mcg/1.0 mL [without preservative]) is not intended
for use in
dialysis/predialysis patients.
Recombivax HB (hepatitis B vaccine [recombinant], MSD), (10 mcg/1.0 mL
and 5
mcg/0.5 mL [without preservative]) is available for use in individuals
for whom a
thimerosal-free vaccine may be desired.
Recombivax HB is for intramuscular injection. The deltoid muscle is
the preferred site
for intramuscular injection in adults. The anterolateral thigh is the
recommended site
for intramuscular injection in infants and young children. Data
suggest that