দেশ: কানাডা
ভাষা: ইংরেজি
সূত্র: Health Canada
HEPATITIS A VIRUS, INACTIVATED
GLAXOSMITHKLINE INC
J07BC02
HEPATITIS A, INACTIVATED, WHOLE VIRUS
720UNIT
SUSPENSION
HEPATITIS A VIRUS, INACTIVATED 720UNIT
INTRAMUSCULAR
15G/50G
Schedule D
VACCINES
Active ingredient group (AIG) number: 0165325001; AHFS:
APPROVED
2001-06-12
_HAVRIX (hepatitis A vaccine, inactivated) _ _Page 1 of 20_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION HAVRIX Hepatitis A vaccine, inactivated 720 ELISA units per 0.5 mL of formaldehyde-inactivated hepatitis A virus (HM175 hepatitis A virus strain) or 1440 ELISA units per 1 mL of formaldehyde-inactivated hepatitis A virus (HM175 hepatitis A virus strain) Suspension for injection, Intramuscular Active immunizing agent against infection by hepatitis A virus ATC Code: J07BC02 GlaxoSmithKline Inc. 100 Milverton Drive, Suite 800 Mississauga, Ontario L5R 4H1 Date of Initial Authorization: December 31, 1996 Date of Revision: November 9, 2023 Submission Control Number: 276326 _©_ _2023 GSK group of companies or its licensor _ _Trademarks are owned by or licensed to the GSK group of companies _ _HAVRIX (hepatitis A vaccine, inactivated) _ _Page 2 of 20_ RECENT MAJOR LABEL CHANGES SECTION DATE 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment APR 2023 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED . RECENT MAJOR LABEL CHANGES ............................................................................................ 2 TABLE OF CONTENTS .............................................................................................................. 2 1 INDICATIONS ............................................................................................................... 4 1.1 Pediatrics ................................................................................................................ 4 1.2 Geriatrics ................................................................................................................ 4 2 CONTRAINDICATIONS ................................................................................................. 4 4 DOSAGE AND ADMINISTRATION ................................................................................. 4 4.2 Recommended Dose and Dosage Adjustment ......................... সম্পূর্ণ নথি পড়ুন