البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
HEPATITIS A VIRUS ANTIGEN, INACTIVATED
MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL
J07BC02
SUSPENSION FOR INJECTION
HEPATITIS A VIRUS ANTIGEN, INACTIVATED 50 U/ML
I.M
Required
MERCK SHARP & DOHME B.V, HOLLAND
HEPATITIS A, INACTIVATED, WHOLE VIRUS
HEPATITIS A, INACTIVATED, WHOLE VIRUS
Vaqta is indicated for active pre-exposure prophylaxis against disease caused by hepatitis A virus in persons 2 years of age and older.
2021-05-31
1 VAQTA ® 25 U / 0.5 ML VAQTA ® 50 U / ML HEPATITIS A VIRUS ANTIGEN, INACTIVATED SUSPENSION FOR INTRAMUSCULAR INJECTION ONLY 1 THERAPEUTIC INDICATIONS 1.1 INDICATIONS AND USE VAQTA 1 [Hepatitis A Vaccine, Inactivated] is indicated for the prevention of disease caused by hepatitis A virus (HAV) in persons 12 months of age and older. The primary dose should be given at least 2 weeks prior to expected exposure to HAV. VAQTA may be administered along with immune globulin (IG) at a separate site with a separate syringe for post-exposure prophylaxis_ [see Clinical Studies (14.5)]_. 1.2 LIMITATIONS OF USE VAQTA will not prevent hepatitis caused by infectious agents other than hepatitis A virus. Because of the long incubation period (approximately 20 to 50 days) for hepatitis A, it is possible for unrecognized hepatitis A infection to be present at the time the vaccine is given. The vaccine may not prevent hepatitis A in such individuals. Vaccination with VAQTA may not result in a protective response in all susceptible vaccinees. 2 DOSAGE AND ADMINISTRATION 2.1 DOSAGE AND SCHEDULE _Children/Adolescents (12 months through 18 years of age): _Vaccination consists of a primary 0.5-mL dose administered intramuscularly, and a 0.5-mL booster dose administered intramuscularly 6 to 18 months later. _ _ _Adults_ (≥_19 years of age_): Vaccination consists of a primary 1.0-mL dose administered intramuscularly, and a 1.0-mL booster dose administered intramuscularly_ _6 to 18 months later. _Interchangeability of the Booster Dose_: A booster dose of VAQTA may be given at 6 to 12 months following the primary dose of another inactivated hepatitis_ _A vaccine_ _(_i.e_._, _HAVRIX 2 )_ [see Clinical Studies (14.6)]._ 2.2 METHOD OF ADMINISTRATION For intramuscular use only. • Shake well to obtain a slightly opaque, white suspension before withdrawal and use. • Thoroughly agitate to maintain suspension of the vaccine. • Discard if the suspension does not appear homogenous or if extraneous particulate matter remains or discoloration اقرأ الوثيقة كاملة