Land: Kanada
Sprache: Englisch
Quelle: Health Canada
CARBETOCIN
FERRING INC
H01BB03
CARBETOCIN
100MCG
SOLUTION
CARBETOCIN 100MCG
INTRAVENOUS
5X100MCG
Prescription
OXYTOCICS
Active ingredient group (AIG) number: 0132909001; AHFS:
CANCELLED POST MARKET
2021-05-18
DURATOCIN (carbetocin injection) Page 1 of 28 PRODUCT MONOGRAPH Pr DURATOCIN ® (Carbetocin Injection) 1 mL ampoule – 100 mcg/mL Injection For Intravenous Use Only Uterotonic Agent Ferring Inc. 200 Yorkland Boulevard Suite 500 North York, ON M2J 5C1 Date of Revision: April 28, 2020 Submission Control No: 236432 DURATOCIN (carbetocin injection) Page 2 of 28 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS ..................................................................................4 ADVERSE REACTIONS ....................................................................................................6 DRUG INTERACTIONS ....................................................................................................8 DOSAGE AND ADMINISTRATION ................................................................................9 OVERDOSAGE ..................................................................................................................9 ACTION AND CLINICAL PHARMACOLOGY ............................................................10 STORAGE AND STABILITY ..........................................................................................14 SPECIAL HANDLING INSTRUCTIONS .......................................................................14 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................14 PART II: SCIENTIFIC INFORMATION ...............................................................................15 PHARMACEUTICAL INFORMATION ..........................................................................15 CLINICAL TRIALS ..........................................................................................................16 TOXICOLOGY ........ Lesen Sie das vollständige Dokument