SCI-B-VAC 2.5 MCG0.5 ML

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

HEPATITIS B VACCINES

Verfügbar ab:

SCIVAC LTD, ISRAEL

ATC-Code:

J07BC01

Darreichungsform:

SUSPENSION FOR INJECTION

Zusammensetzung:

HEPATITIS B VACCINES 2.5 MCG / 0.5 ML

Verabreichungsweg:

I.M

Verschreibungstyp:

Required

Hergestellt von:

SCIVAC LTD, ISRAEL

Therapiegruppe:

HEPATITIS B, PURIFIED ANTIGEN

Therapiebereich:

HEPATITIS B, PURIFIED ANTIGEN

Anwendungsgebiete:

For active immunization against Hepatitis B virus. In high dose: it is indicated for immunization of neonates & children in highly endemic areas.

Berechtigungsdatum:

2015-01-31

Fachinformation

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sci-B-Vac 2.5 µg /0.5 ml
Sci-B-Vac 5µg/0.5 ml
Sci-B-Vac 10µg/1 ml
Hepatitis B vaccine (recombinant, adsorbed)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient:
Sci-B-Vac 2.5µg/0.5ml contains hepatitis B surface antigen 2.5
µg/0.5ml
1,2, 3
Sci-B-Vac 5µg/0.5ml contains hepatitis B surface antigen 5 µg/0.5ml
1,2, 3
Sci-B-Vac 10µg/ml contains hepatitis B surface antigen 10 µg/ml
1,2, 3
1
Hepatitis B surface antigen (S [83%], pre-S2 [11%] and pre-S1 [6%])
2
Adsorbed on 500 micrograms of Al
3+
as aluminium hydroxide, hydrated per ml of vaccine
3
Produced in Chinese Hamster Ovary cells by recombinant DNA technology
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection (injection)
Clear, colourless with a fine white deposit.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Sci-B-Vac is indicated for active immunization against hepatitis B
virus (HBV) infection.
Immunization against hepatitis B is expected, in the long term, to
reduce not only the incidence of the
disease, but also its chronic complications such as massive hepatic
necrosis, cirrhosis of the liver and
hepatocellular carcinoma.
Vaccination with Sci-B-Vac is recommended for all ages in those
subjects who are or will be at
increased risk of infection with HBV. In areas of high prevalence of
infection, the majority of the
population is at high risk, especially neonates and children. In high
risk areas, infection occurs
primarily through mother to child and horizontal transmission.
Therefore, vaccination should be
targeted to prevent such transmission. In areas of intermediate and
low prevalence, vaccination is
recommended for neonates, infants and adolescents, as well as subjects
who are or will be at increased
risk of infection, such as:
•
Health care personnel
•
Frequent recipients of blood products
•
Infants born to HBsAg-positive mothers
•
Personnel and residents of public health institutions
•
Persons at incr