Ülke: Kanada
Dil: İngilizce
Kaynak: Health Canada
TRIPTORELIN (TRIPTORELIN PAMOATE)
KNIGHT THERAPEUTICS INC.
L02AE04
TRIPTORELIN
3.75MG
POWDER FOR SUSPENSION, SUSTAINED-RELEASE
TRIPTORELIN (TRIPTORELIN PAMOATE) 3.75MG
INTRAMUSCULAR
15G/50G
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0137103001; AHFS:
APPROVED
2020-04-02
_Product Monograph Master Template _ _Template Date: September 2020 _ _TRELSTAR_ _®_ _ (triptorelin for injectable suspension) _ _Page 1 of 55_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR TRELSTAR ® Triptorelin for injectable suspension Powder for injectable suspension, 3.75 mg triptorelin (as pamoate) per vial (1 month sustained-release formulation), 11.25 mg triptorelin (as pamoate) per vial (3 month sustained-release formulation), 22.5 mg triptorelin (as pamoate) per vial (6 month sustained-release formulation), intramuscular injection Luteinizing Hormone-Releasing Hormone (LHRH) Analog Knight Therapeutics Inc. 3400 De Maisonneuve W., Suite 1055 Montreal, QC Canada H3Z 3B8 Date of Initial Authorization: MAY 06, 1999 Date of Revision: MAR 27, 2024 Submission Control Number: 280867 _ _ _Product Monograph Master Template _ _Template Date: September 2020 _ _TRELSTAR_ _®_ _ (triptorelin for injectable suspension) _ _Page 2 of 55_ RECENT MAJOR LABEL CHANGES 3 SERIOUS WARNINGS AND PRECAUTIONS BOX [09/2022] 4 DOSAGE AND ADMINISTRATION, 4.3 Reconstitution [01/2024] 7 WARNINGS AND PRECAUTIONS, All Indications, Neurologic [11/2023] 7 WARNINGS AND PRECAUTIONS, Endometriosis, Musculoskeletal [09/2022] 7 WARNINGS AND PRECAUTIONS, Endometriosis, Endocrine and Metabolism [01/2024] 7 WARNINGS AND PRECAUTIONS, Prostate Cancer, Endocrine and Metabolism [01/2024] 7 WARNING AND PRECAUTIONS, 7.1.3 Pediatrics [01/2024] 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 ...................................................................... 5 1 INDICATIONS ............................................................................................................... Belgenin tamamını okuyun