País: Canadá
Idioma: inglés
Fuente: Health Canada
RABIES IMMUNOGLOBULIN (HUMAN)
GRIFOLS THERAPEUTICS LLC
J06BB05
RABIES IMMUNOGLOBULIN
300UNIT
SOLUTION
RABIES IMMUNOGLOBULIN (HUMAN) 300UNIT
INTRAMUSCULAR
15G/50G
Schedule D
SERUMS
Active ingredient group (AIG) number: 0110666003; AHFS:
APPROVED
2019-03-13
_ _ _ _ _HYPERRAB® (Rabies Immunoglobulin [Human]) _ _Page 1 of 17_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION HYPERRAB® Rabies Immunoglobulin [Human] Injectable Solution, 300 IU per mL For infiltration and intramuscular injection Manufacturer’s Standard Passive Immunizing Agent ATC: J06BB05 Manufactured by: Grifols Therapeutics LLC 8368 U.S. 70 Bus. Hwy West Clayton, North Carolina 27520 U.S.A. Imported and Distributed by: Grifols Canada Ltd. 5060 Spectrum Way, Suite 405 Mississauga, Ontario L4W 5N5 Date of Initial Authorization: July 3, 1975 Date of Revision: [TBD] Submission Control Number: 247808 Date of Approval: March 19, 2021 _ _ _ _ _ _ _HYPERRAB® (Rabies Immunoglobulin [Human]) _ _Page 2 of 17_ TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. TABLE OF CONTENTS ................................................................................................................2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................4 1 INDICATIONS ................................................................................................................4 1.1 Pediatrics ............................................................................................................4 1.2 Geriatrics.............................................................................................................4 2 CONTRAINDICATIONS ...................................................................................................4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ..............................................................4 4 DOSAGE AND ADMINISTRATION...................................................................................5 4.2 Recommended Dose and Dosage Adjustment.......................................................5 4.4 Administration.....................................................................................................5 5 OVERDOSAGE ........... Leer el documento completo