Land: Canada
Sprog: engelsk
Kilde: Health Canada
OCTREOTIDE (OCTREOTIDE ACETATE)
TEVA CANADA LIMITED
H01CB02
OCTREOTIDE
50MCG
SOLUTION
OCTREOTIDE (OCTREOTIDE ACETATE) 50MCG
INTRAVENOUS
1ML
Prescription
MISCELLANEOUS THERAPEUTIC AGENTS
Active ingredient group (AIG) number: 0121548008; AHFS:
CANCELLED POST MARKET
2018-06-19
PRODUCT MONOGRAPH PR OCTREOTIDE INJECTION (Octreotide as acetate) Single Dose Vials (1 mL) 50 µg/mL, 100 µg/mL, 500 µg/mL Multidose Vials (5 mL) 200 µg/mL STERILE SYNTHETIC OCTAPEPTIDE ANALOGUE OF SOMATOSTATIN Teva Canada Limited Date of Preparation: 30 Novopharm Court March 28, 2014 Toronto, Ontario Canada M1B 2K9 www.tevacanada.com Submission Control No.: 172353 2 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ......................................................... 3 SUMMARY PRODUCT INFORMATION ............................................................................... 3 INDICATIONS AND CLINICAL USE ..................................................................................... 3 CONTRAINDICATIONS .......................................................................................................... 5 WARNINGS AND PRECAUTIONS ......................................................................................... 5 ADVERSE REACTIONS ........................................................................................................... 9 DRUG INTERACTIONS ......................................................................................................... 14 DOSAGE AND ADMINISTRATION ..................................................................................... 15 OVERDOSAGE ....................................................................................................................... 17 ACTION AND CLINICAL PHARMACOLOGY ................................................................... 18 STORAGE AND STABILITY ................................................................................................. 19 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................... 19 PART II: SCIENTIFIC INFORMATION ............................................................................... 21 PHARMACEUTICAL INFORMATION ................................................................................. 21 DETAILED PHARMACOLOGY .......... Læs hele dokumentet