Land: Kanada
Sprache: Englisch
Quelle: Health Canada
RABIES IMMUNOGLOBULIN (HUMAN)
KAMADA LTD
J06BB05
RABIES IMMUNOGLOBULIN
150UNIT
SOLUTION
RABIES IMMUNOGLOBULIN (HUMAN) 150UNIT
INTRAMUSCULAR
10 ML
Schedule D
SERUMS
Active ingredient group (AIG) number: 0110666002; AHFS:
APPROVED
2018-11-07
_KamRAB™ - Product Monograph _ _Page 1 of 23_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION KAMRAB TM RABIES IMMUNOGLOBULIN (HUMAN) Solution for intramuscular injection (150 IU/mL) 2.0 mL vials and 10.0 mL vials Passive, Transient Post-Exposure Agent For Prophylaxis Of Rabies Manufactured by: Kamada Ltd. 2 Holzman St, Science Park, P.O. Box 4081, Rehovot 7670402, Israel Imported by: Imported by/Importé par: Quality & Compliance Services Inc., Mississauga, ON L5N 5R1 for/pour Valneva Canada Inc., Kirkland, QC H9H 5B9 Submission Control No: 211541 Date of Initial Approval: November 7, 2018 _ _ _KamRAB™ - Product Monograph _ _Page 2 of 23_ TABLE OF CONTENTS 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. DOSAGE AND ADMINISTRATION ................................................................ 4 3.1. Dosing Considerations ................................................................................... 4 3.2. Recommended Dose and Dosage Adjustment .............................................. 5 3.3. Administration ................................................................................................ 5 3.4. Reconstitution ................................................................................................ 6 3.5. Missed Dose .................................................................................................. 6 4. OVERDOSAGE ................ Lesen Sie das vollständige Dokument