ENGERIX

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

Hepatitis B surface antigen recombinant, Quantity: 10 microgram

Disponible depuis:

GlaxoSmithKline Australia Pty Ltd

DCI (Dénomination commune internationale):

Hepatitis B surface antigen recombinant

forme pharmaceutique:

Injection, suspension

Composition:

Excipient Ingredients: water for injections; aluminium hydroxide hydrate; dibasic sodium phosphate dihydrate; sodium chloride; monobasic sodium phosphate

Mode d'administration:

Subcutaneous, Intramuscular

Unités en paquet:

25 x 0.5mL, 1 x 0.5mL, 10 x 0.5mL

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

ENGERIX-B is indicated for active immunisation against hepatitis B virus infection. The NH&MRC* recommend all infants, young children and unvaccinated adolescents receive a primary course of immunisation against hepatitis B. The NH&MRC also recommends immunisation for persons who are at substantial risk and have been demonstrated or judged to be susceptible to the hepatitis B virus. Groups identified at increased risk of acquiring HBV infection include: Infants born to carrier (HBsAg-positive) mothers; Individuals for whom post-exposure prophylaxis for hepatitis B is indicated; Household contacts (other than sexual partners) of acute and chronic hepatitis B cases and carriers; susceptible sexual contacts. Risk occurs in susceptible (anti-HBs negative) partners of HBV carriers and patients with acute hepatitis B; Susceptible clients of STD (sexually transmitted disease) clinics, and sexually active men who have sex with men are also at increased risk of infection; Injecting drug users; Haemodialysis patients,

Descriptif du produit:

Visual Identification: Turbid liquid with a slow settling white deposit and a colourless supernatant. The precipitate is easily resuspended when shaken.; 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
ENGERIX-B (HEPATITIS B SURFACE ANTIGEN RECOMBINANT (YEAST))
VACCINE, SUSPENSION FOR INJECTION
1
NAME OF THE MEDICINE
Hepatitis B surface antigen recombinant (yeast)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ENGERIX-B PAEDIATRIC DOSE: 10 µg dose vaccine
1 dose (0.5 mL) contains:
Hepatitis B surface antigen
1, 2
10 micrograms
1
Adsorbed on aluminium hydroxide hydrate
Total: 0.25 milligrams Al
3+
2
Produced in yeast cells (_Saccharomyces cerevisiae_) by recombinant
DNA technology
ENGERIX-B: 20 µg dose vaccine
1 dose (1 mL) contains:
Hepatitis B surface antigen
1, 2
20 micrograms
1
Adsorbed on aluminium hydroxide hydrate
Total: 0.50 milligrams Al
3+
2
Produced in yeast cells (_Saccharomyces cerevisiae_) by recombinant
DNA technology
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
The manufacture of this product includes exposure to bovine derived
materials. No evidence
exists that any case of vCJD (considered to be the human form of
bovine spongiform
encephalopathy) has resulted from the administration of any vaccine
product.
ENGERIX-B is highly purified, and meets the WHO requirements for
recombinant hepatitis B
vaccines. No substances of human origin are used in its manufacture.
3
PHARMACEUTICAL FORM
Suspension for injection.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ENGERIX-B is indicated for active immunisation against hepatitis B
virus infection. The use of
the vaccine should be in accordance with official recommendations.
2
As hepatitis D (caused by the delta agent) does not occur in the
absence of hepatitis B
infection, it can be expected that hepatitis D will also be prevented
by vaccination with
ENGERIX-B. The vaccine will not protect against infection caused by
hepatitis A, hepatitis C
and hepatitis E viruses, and other pathogens known to infect the
liver._ _
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
The vaccine can be administered at any age from birth onwards.
Vaccination of individuals
who have antibodies against hepatitis B virus from