Quốc gia: Canada
Ngôn ngữ: Tiếng Anh
Nguồn: Health Canada
SUMATRIPTAN (SUMATRIPTAN SUCCINATE)
DR REDDY'S LABORATORIES LTD
N02CC01
SUMATRIPTAN
6MG
SOLUTION
SUMATRIPTAN (SUMATRIPTAN SUCCINATE) 6MG
SUBCUTANEOUS
100
Prescription
Active ingredient group (AIG) number: 0123238006; AHFS:
APPROVED
2022-10-28
Page 1 of 37 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR SUMATRIPTAN INJECTION, USP 6 mg / 0.5 mL (as sumatriptan succinate) Subcutaneous Injection and Autoinjector 5-HT 1 Receptor Agonist Migraine Therapy Manufactured by : Dr. Reddy’s Laboratories Ltd., Bachupally -500 090 India Imported and Distributed by : Dr. Reddy’s Laboratories Canada Inc., Mississauga, ON, L4W 4Y1 Canada Date of Preparation: October 26, 2022 Submission Control Number: 249687 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED . Table of Contents 1 INDICATIONS .................................................................................................................................... 4 1.1 Pediatrics .................................................................................................................................... 4 1.2 Geriatrics .................................................................................................................................... 4 2 CONTRAINDICATIONS ..................................................................................................................... 4 4 DOSAGE AND ADMINISTRATION .................................................................................................... 5 4.1 Dosing Considerations ................................................................................................................ 5 4.2 Recommended Dose and Dosage Adjustment ............................................................................. 5 4.4 Administration ........................................................................................................................... 6 5 OVERDOSAGE ................................................................................................................................. 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .............................................. 6 7 WARNINGS AND PRECAUTIONS ........................................ Đọc toàn bộ tài liệu