Transcription of DEPO-TESTOSTERONE - Pfizer Canada
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DEPO-TESTOSTERONE - Pfizer Canada
DEPO-TESTOSTERONE Product Monograph Page 1 of 20 PRODUCT MONOGRAPH DEPO-TESTOSTERONE testosterone cypionate injection 100 mg/mL sterile solution USP Androgens Pfizer Canada Inc. 17, 300 Trans- Canada Highway Kirkland, Quebec H9J 2M5 Date of Revision: 12 July 2018 Submission Control No: 217239 Pfizer Canada Inc., 2018 DEPO-TESTOSTERONE Product Monograph 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.
DEPO-TESTOSTERONE contains benzyl alcohol. The preservative benzyl alcohol has been associated with serious adverse events, including the “gasping syndrome”, and death in pediatric patients. Premature and low-birth weight infants may be more likely to develop toxicity.
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