国家: 加拿大
语言: 英文
来源: Health Canada
PRIMAQUINE PHOSPHATE
SANOFI-AVENTIS CANADA INC
P01BA03
PRIMAQUINE
26.3MG
TABLET
PRIMAQUINE PHOSPHATE 26.3MG
ORAL
100
Prescription
ANTIMALARIALS
Active ingredient group (AIG) number: 0152571001; AHFS:
APPROVED
2001-04-02
_Product Monograph – PRIMAQUINE _ _ _ _Page 1 of 24_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr PRIMAQUINE ® Primaquine phosphate tablets, USP 26.3 mg primaquine phosphate (equivalent to 15 mg primaquine base) Antimalarial sanofi-aventis Canada Inc. 2905, Place Louis-R.-Renaud Laval, Quebec H7V 0A3 Date of Revision: May 27, 2020 Submission Control No: 226711 _Product Monograph – PRIMAQUINE _ _ _ _Page 2 of 24_ RECENT MAJOR LABEL CHANGES Indications (1) 05/2020 Contraindications (2) 05/2020 Dosage and Administration, Recommended Dose and Dosage Adjustment (3.2) 05/2020 Dosage and Administration, Missed Dose (3.4) 05/2020 Warnings and Precautions (6) 05/2020 Warnings and Precautions, Special Populations (6.1) 05/2020 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ......................................................................................2 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 .............................................................................5 3.1 Dosing Considerations ...............................................................................................5 3.2 Recommended Dose and Dosage Adjustment ...........................................................5 3.3 Administration .................................................................... 阅读完整的文件