Country: Canada
Language: English
Source: Health Canada
SOMATROPIN
PFIZER CANADA ULC
H01AC01
SOMATROPIN
2MG
POWDER FOR SOLUTION
SOMATROPIN 2MG
SUBCUTANEOUS
7
Prescription
PITUITARY
Active ingredient group (AIG) number: 0131827022; AHFS:
APPROVED
2013-02-07
PRODUCT MONOGRAPH PR GENOTROPIN ® GOQUICK TM SOMATROPIN [RDNA ORIGIN] FOR INJECTION Lyophilized Powder for reconstitution 5 mg, 5.3 mg, 12 mg pre-filled pen, GoQuick and PR GENOTROPIN ® MINIQUICK TM SOMATROPIN [RDNA ORIGIN] FOR INJECTION Lyophilized Powder for reconstitution 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1.0 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, and 2.0 mg prefilled syringe, MiniQuick Human Growth Hormone Pfizer Canada ULC 17 300 Trans-Canada Highway Kirkland, Quebec H9J 2M5 Date of Initial Approval: January 19, 1998 Date of Revision: June 22, 2020 Submission Control No: 229726 ®Pfizer Health AB Pfizer Canada ULC, Licensee © Pfizer Canada Inc 2020 _ _ _GENOTROPIN* (SOMATROPIN FOR INJECTION) Product Monograph _ _Page 2 of 92_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION......................................................... 3 SUMMARY PRODUCT INFORMATION ........................................................................ 3 DESCRIPTION ................................................................................................................... 3 INDICATIONS AND CLINICAL USE .............................................................................. 3 CONTRAINDICATIONS ................................................................................................... 5 WARNINGS AND PRECAUTIONS.................................................................................. 6 ADVERSE REACTIONS ................................................................................................. 14 DRUG INTERACTIONS .................................................................................................. 36 DOSAGE AND ADMINISTRATION .............................................................................. 37 OVERDOSAGE ................................................................................................................ 39 ACTION AND CLINICAL PHARMACOLOGY ............................................................ 39 STORAGE AND STABILITY............................ Read the complete document