Quest for the right Drug
סיי-בי-ואק 10 מק"ג/מ"ל SCI-B-VAC 10 MCG/ML (HEPATITIS B VACCINES)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
תוך-שרירי : I.M
צורת מינון:
תרחיף להזרקה : SUSPENSION FOR INJECTION
עלון לרופא
מינוניםPosology התוויות
Indications תופעות לוואי
Adverse reactions התוויות נגד
Contraindications אינטראקציות
Interactions מינון יתר
Overdose הריון/הנקה
Pregnancy & Lactation אוכלוסיות מיוחדות
Special populations תכונות פרמקולוגיות
Pharmacological properties מידע רוקחי
Pharmaceutical particulars אזהרת שימוש
Special Warning עלון לרופא
Physicians Leaflet
Indications : התוויות
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 increased risk of the disease due to their sexual practices • Travelers to areas with high endemicity of HBV • Persons originating from areas of high endemicity • Users of illicit injectable drugs • Military personnel, police personnel and anybody who through their work or personal lifestyle may be exposed to HBV • Family members and others in intimate contact with persistent HBsAg-positive individuals. Persons who develop anti-HBs antibodies following active infection with the hepatitis B vaccine are protected against the disease if they are re-exposed to the virus. Clinical trials have shown that Sci-B-Vac induced protective levels of antibody in up to 100% of healthy adults who received the recommended three-dose regimen of 10 μg/dose. Sci-B-Vac is highly immunogenic in children. The specific antibody titers tend to be an order of magnitude higher in children than in adults when the recommended doses are administered. Children tend to achieve seroprotection more frequently than adults.
שימוש לפי פנקס קופ''ח כללית 1994
Prevention of hepatitis b infection in those who are at increased risk such as health care personnel, patients in hemodialysis units, infants born to HBsAg positive mothers, sexual and household contacts of HBsAg positive persons
תאריך הכללה מקורי בסל
01/01/1995
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