Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
HEPATITIS B SURFACE ANTIGEN (RECOMBINANT)
MERCK CANADA INC
J07BC01
HEPATITIS B, PURIFIED ANTIGEN
10MCG
SUSPENSION
HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) 10MCG
INTRAMUSCULAR
0.5ML/1ML/10X1.0ML
Schedule D
VACCINES
Active ingredient group (AIG) number: 0119570001; AHFS:
APPROVED
2005-09-14
RECOMBIVAX HB ® (hepatitis B vaccine [recombinant]) _Page 1 of 26_ PRODUCT MONOGRAPH RECOMBIVAX HB ® (hepatitis B vaccine [recombinant]) Suspension for Injection Vaccine for immunization against infection caused by hepatitis B virus including all known subtypes MERCK CANADA INC. 16750 route Transcanadienne Kirkland, Quebec H9H 4M7 Date of Revision: May 15, 2012 GLOBAL TRADE IDENTIFICATION NO.: Pediatric: 0 67055 04523 3 (1 x 0.5 mL) Adult: 0 67055 04569 1 (1 x 1 mL); 0 67055 04633 9 (10 x 1 mL) Adult Dialysis: 0 67055 04560 8 (1 x 1 mL) SUBMISSION CONTROL NO: 155287 DATE OF APPROVAL: MAY 22, 2012 _ _ RECOMBIVAX HB ® (hepatitis B vaccine [recombinant]) _Page 2 of 26_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION.........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 DESCRIPTION....................................................................................................................3 INDICATIONS AND CLINICAL USE..............................................................................3 CONTRAINDICATIONS ...................................................................................................5 WARNINGS AND PRECAUTIONS..................................................................................5 ADVERSE REACTIONS....................................................................................................6 DRUG INTERACTIONS ....................................................................................................9 DOSAGE AND ADMINISTRATION..............................................................................10 OVERDOSAGE ................................................................................................................13 ACTION AND CLINICAL PHARMACOLOGY ............................................................14 STORAGE AND STABILITY..........................................................................................15 DOSAGE Přečtěte si celý dokument