দেশ: ইস্রায়েল
ভাষা: ইংরেজি
সূত্র: Ministry of Health
HEPATITIS B VACCINES
SCIVAC LTD, ISRAEL
J07BC01
SUSPENSION FOR INJECTION
HEPATITIS B VACCINES 2.5 MCG / 0.5 ML
I.M
Required
SCIVAC LTD, ISRAEL
HEPATITIS B, PURIFIED ANTIGEN
HEPATITIS B, PURIFIED ANTIGEN
For active immunization against Hepatitis B virus. In high dose: it is indicated for immunization of neonates & children in highly endemic areas.
2015-01-31
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 সম্পূর্ণ নথি পড়ুন