Χώρα: Καναδάς
Γλώσσα: Αγγλικά
Πηγή: Health Canada
SOMATROPIN; SODIUM CHLORIDE
EMD SERONO, A DIVISION OF EMD INC., CANADA
H01AC01
SOMATROPIN
3.3MG; 5ML
POWDER FOR SOLUTION
SOMATROPIN 3.3MG; SODIUM CHLORIDE 5ML
INTRAMUSCULAR
5ML
Prescription
PITUITARY
Active ingredient group (AIG) number: 0228536004; AHFS:
APPROVED
1998-05-05
_ _ _Saizen_ _®_ _ Product Monograph _ _Page 1 of 94_ PRODUCT MONOGRAPH PR SAIZEN ® Somatropin for Injection Lyophilized Powder for reconstitution 3.33 mg/vial, 5 mg/vial PR SAIZEN ® CLICK.EASY Somatropin for Injection Lyophilized Powder for reconstitution 8.8 mg (5.83 mg/mL) PR SAIZEN ® Somatropin Solution for Injection in a Cartridge 6 mg (5.83 mg/mL) 12 mg (8 mg/mL) 20 mg (8 mg/mL) Pharmaceutical Standard: Professed Therapeutic Classification: Human Growth Hormone EMD Serono, a Division of EMD Inc., Canada 2695 North Sheridan Way, Suite 200 Mississauga, Ontario, Canada L5K 2N6 www.emdserono.ca EMD Serono is a business of Merck KGaA, Darmstadt, Germany Submission Control No.: 220772 Date of Authorization: December 21, 2018 ® Registered trademark of Merck KGaA, Darmstadt, Germany _ _ _Saizen_ _®_ _ Product Monograph _ _Page 2 of 94_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ........................................................ 3 SUMMARY PRODUCT INFORMATION ............................................................................ 3 DESCRIPTION ......................................................................................................................... 3 INDICATIONS AND CLINICAL USE ................................................................................... 4 CONTRAINDICATIONS ........................................................................................................ 5 WARNINGS AND PRECAUTIONS ....................................................................................... 6 ADVERSE REACTIONS ....................................................................................................... 13 DRUG INTERACTIONS ....................................................................................................... 37 DOSAGE AND ADMINISTRATION ................................................................................... 38 OVERDOSAGE ........................................................................................................... Διαβάστε το πλήρες έγγραφο