Country: Canada
Language: English
Source: Health Canada
BUSERELIN (BUSERELIN ACETATE)
CHEPLAPHARM ARZNEIMITTEL GMBH
L02AE01
BUSERELIN
1MG
SOLUTION
BUSERELIN (BUSERELIN ACETATE) 1MG
SUBCUTANEOUS
15G/50G
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0117891001; AHFS:
APPROVED
2020-06-04
_ _ _ _ _Page 1 of 57_ PRODUCT MONOGRAPH Pr SUPREFACT ® Buserelin Acetate Injection 1 mg/mL Nasal Solution 1 mg/mL _ _ Luteinizing Hormone-Releasing Hormone (LHRH) Analogue _ _ CHEPLAPHARM Arzneimittel GmbH Ziegelhof 24 17489 Greifswald Germany Distributed by Xediton Pharmaceuticals Inc. 2000 Argentia Rd, Mississauga Ontario L5N 1W1 Tel: 1-888-XEDITON Date of Revision: June 2, 2020 Submission Control No.: 237854 _ _ _ _ _Page 2 of 57_ TABLE OF CONTENTS I: HEALTH PROFESSIONAL INFORMATION ....................................................................... 3 SUMMARY PRODUCT INFORMATION ......................................................................... 3 INDICATIONS AND CLINICAL USE ............................................................................... 3 CONTRAINDICATIONS .................................................................................................... 4 WARNINGS AND PRECAUTIONS ................................................................................... 5 ADVERSE REACTIONS ................................................................................................... 10 DRUG INTERACTIONS ................................................................................................... 17 DOSAGE AND ADMINISTRATION ............................................................................... 18 OVERDOSAGE ................................................................................................................. 20 ACTION AND CLINICAL PHARMACOLOGY ............................................................. 20 STORAGE AND STABILITY ........................................................................................... 22 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................. 22 PART II: SCIENTIFIC INFORMATION ................................................................................. 24 PHARMACEUTICAL INFORMATION ........................................................................... 24 CLINICAL TRIALS ........... Read the complete document