البلد: كندا
اللغة: الإنجليزية
المصدر: Health Canada
TESTOSTERONE CYPIONATE
TARO PHARMACEUTICALS INC
G03BA03
TESTOSTERONE
100MG
SOLUTION
TESTOSTERONE CYPIONATE 100MG
INTRAMUSCULAR
15G/50G
Schedule G (CDSA IV)
ANDROGENS
Active ingredient group (AIG) number: 0106401001; AHFS:
APPROVED
2020-01-29
PRODUCT MONOGRAPH TARO-TESTOSTERONE CYPIONATE INJECTION Testosterone Cypionate Injection 100 mg / mL sterile solution Taro Standard Androgens Taro Pharmaceutical Inc. 130 East Drive Brampton, ON L6T 1C1 Canada Date of Revision: May 26, 2022 Submission Control No: 263625 _Page 1 of 20_ _Page 2 of 20_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ..................................................... 3 SUMMARY PRODUCT INFORMATION ....................................................................3 INDICATIONS AND CLINICAL USE..........................................................................3 CONTRAINDICATIONS..............................................................................................4 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................4 WARNINGS AND PRECAUTIONS .............................................................................4 ADVERSE REACTIONS ..............................................................................................8 DRUG INTERACTIONS ..............................................................................................9 DOSAGE AND ADMINISTRATION ......................................................................... 10 OVERDOSAGE ......................................................................................................... 11 ACTION AND CLINICAL PHARMACOLOGY ........................................................ 12 STORAGE AND STABILITY .................................................................................... 13 SPECIAL HANDLING INSTRUCTIONS ................................................................... 14 DOSAGE FORMS, COMPOSITION AND PACKAGING .......................................... 14 PART II: SCIENTIFIC INFORMATION ......................................................................... 15 PHARMACEUTICAL INFORMATION ..................................................................... 15 CLINICAL TRIALS ............................................................. اقرأ الوثيقة كاملة