Quốc gia: Canada
Ngôn ngữ: Tiếng Anh
Nguồn: Health Canada
OCTREOTIDE (OCTREOTIDE ACETATE)
MONT-PHARMA INC
H01CB02
OCTREOTIDE
100MCG
SOLUTION
OCTREOTIDE (OCTREOTIDE ACETATE) 100MCG
INTRAVENOUS
100
Prescription
Active ingredient group (AIG) number: 0121548001; AHFS:
APPROVED
2023-03-07
1 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATIO N PR OCTREOTIDE INJECTION 50 MCG / ML, 100 MCG / ML, 200 MCG / ML, 500 MCG / ML OCTREOTIDE (AS ACETATE) Solution for Subcutaneous injection or intravenous infusion Synthetic Octapeptide Analogue of Somatostatin Mont-Pharma Inc 2379 Rue Guenette Montreal, Quebec H4R 2E9 SUBMISSION CONTROL NUMBER: 271522 DATE OF INITIAL AUTHORIZATION: MAR 2, 2023 2 RECENT MAJOR LABEL CHANGES 4 DOSAGE AND ADMINISTRATION, 4.2 RECOMMENDED DOSE AND DOSAGE ADJUSTMENT, CARCINOID TUMORS 03/2023 4 DOSAGE AND ADMINISTRATION, 4.3 RECOMMENDED DOSE AND DOSAGE ADJUSTMENT, RECONSTITUTION, PARENTERAL PRODUCTS 03/2023 7 WARNING AND PRECAUTIONS, HEPATIC/ BILIARY / PANCREATIC 03/2023 7 WARNING AND PRECAUTIONS, MONITORING AND LABORATORY TESTS 03/2023 7 WARNING AND PRECAUTIONS, FERTILITY 03/2023 7 WARNING AND PRECAUTIONS, TERATOGENIC RISK 03/2023 7 WARNING AND PRECAUTIONS, 7.1.4 GERIATRICS 03/2023 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 PART I: HEALTH PROFESSIONAL INFORMATION ................................................................. 4 1. INDICATIONS ............................................................................................................................. 4 1.1 Pediatrics .................................................................................................................................... 5 1.2 Geriatrics .................................................................................................................................... 5 2. CONTRAINDICATIONS ............................................................................................................ 5 4. DOSAGE AND ADMINISTRATION ............................... Đọc toàn bộ tài liệu