TWINRIX JUNIOR (combined hepatitis A & hepatitis B vaccine) 0.5 mL injection vial thiomersal & preservative free

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

Hepatitis B surface antigen recombinant, Quantity: 20 microgram/mL; Hepatitis a virus antigen, Quantity: 720 ELISA unit/mL

Disponible depuis:

GlaxoSmithKline Australia Pty Ltd

DCI (Dénomination commune internationale):

Hepatitis a virus antigen,Hepatitis B surface antigen recombinant

forme pharmaceutique:

Injection, suspension

Composition:

Excipient Ingredients: dibasic sodium phosphate heptahydrate; neomycin sulfate; aluminium hydroxide hydrate; formaldehyde solution; trometamol; aluminium phosphate; water for injections; polysorbate 20; monobasic sodium phosphate; sodium chloride; acetic acid; leucine; phenylalanine; methionine; lysine hydrochloride; isoleucine; valine; histidine; threonine; tryptophan; alanine; arginine; proline; tyrosine; serine; sodium acetate; dibasic potassium phosphate; magnesium chloride hexahydrate; glycine

Mode d'administration:

Intramuscular

Unités en paquet:

1 x 0.5mL

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

Twinrix (720/20) is indicated for active immunisation against hepatitis A and hepatitis B virus infection in adults and children from 1 year of age. Twinrix Junior (360/10) is indicated for use in children aged 1 to 15 years.

Descriptif du produit:

Visual Identification: fine white deposit with a clear colourless supernatant. The precipitate is easily resuspended when shaken. Once shaken the vaccine is slightly opaque.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Statut de autorisation:

Registered

Résumé des caractéristiques du produit

1
AUSTRALIAN PRODUCT INFORMATION
TWINRIX (720/20) AND TWINRIX JUNIOR (360/10) (COMBINED
HEPATITIS A AND HEPATITIS B VACCINE) SUSPENSION FOR INJECTION
1
NAME OF THE MEDICINE
Combined hepatitis A and hepatitis B vaccine_ _
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
TWINRIX is a non-infectious combination vaccine containing hepatitis A
virus antigen and
hepatitis B surface antigen (rys).
Each 1 mL dose of TWINRIX contains 720 ELISA units of hepatitis A
virus antigen and 20
micrograms of hepatitis B surface antigen (rys). The viral antigens
are adsorbed on 0.45 mg
aluminium in the form of aluminium phosphate and aluminium hydroxide
hydrate and
suspended in a solution containing 9 mg of sodium chloride.
Each 0.5 mL dose of TWINRIX Junior contains 360 ELISA units of
hepatitis A virus antigen
and 10 micrograms of hepatitis B surface antigen (rys). The viral
antigens are adsorbed on
0.225 mg aluminium in the form of aluminium phosphate and aluminium
hydroxide hydrate
and suspended in a solution containing 4.5 mg of sodium chloride.
TWINRIX is formulated using the HM 175 strain of hepatitis A grown in
human cell culture
(MRC5), and inactivated with formaldehyde. The hepatitis B surface
antigen (rys)
component is produced by culturing genetically-engineered
_Saccharomyces cerevisiae_ yeast
cells (Baker’s yeast), which carry the relevant gene of an adw
subtype, of the surface
antigen of the hepatitis B virus. Both the hepatitis A virus antigen
and hepatitis B surface
antigen (rys) are purified by several physico-chemical steps, and
formulated as separate
antigen suspensions adsorbed onto aluminium salts. TWINRIX is produced
by pooling bulk
preparations of the purified antigens. The bulk hepatitis A virus
antigen and hepatitis B
surface antigen (rys) preparations are identical to those used in the
manufacture of the
currently licensed monovalent hepatitis A (Havrix) and hepatitis B
(Engerix-B) vaccines.
Standardised fermentation and purification procedures ensure batch to
batch consistency.
The vaccines are free of associa