OCTREOTIDE INJECTION SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

OCTREOTIDE (OCTREOTIDE ACETATE)

Saatavilla:

TEVA CANADA LIMITED

ATC-koodi:

H01CB02

INN (Kansainvälinen yleisnimi):

OCTREOTIDE

Annos:

50MCG

Lääkemuoto:

SOLUTION

Koostumus:

OCTREOTIDE (OCTREOTIDE ACETATE) 50MCG

Antoreitti:

INTRAVENOUS

Kpl paketissa:

1ML

Prescription tyyppi:

Prescription

Terapeuttinen alue:

MISCELLANEOUS THERAPEUTIC AGENTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0121548008; AHFS:

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2018-06-19

Valmisteyhteenveto

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
..........