Šalis: Naujoji Zelandija
kalba: anglų
Šaltinis: Medsafe (Medicines Safety Authority)
Hepatitis B vaccine, rDNA 10 µg/mL
Merck Sharp & Dohme (New Zealand) Limited
Hepatitis B vaccine, rDNA 10 µg/mL
10 mcg/dose
Suspension for injection
Active: Hepatitis B vaccine, rDNA 10 µg/mL Excipient: Aluminium as amorphous aluminum hydroxyphosphate sulphate Borax Formaldehyde Potassium thiocyanate Sodium chloride Water for injection
Prescription
Merck Sharp & Dohme Corp
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.
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)
2017-07-27
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 Perskaitykite visą dokumentą