OCTREOTIDE ACETATE INJECTION - 500MCG/ML SOLUTION

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

OCTREOTIDE (OCTREOTIDE ACETATE)

Beschikbaar vanaf:

SANDOZ CANADA INCORPORATED

ATC-code:

H01CB02

INN (Algemene Internationale Benaming):

OCTREOTIDE

Dosering:

500MCG

farmaceutische vorm:

SOLUTION

Samenstelling:

OCTREOTIDE (OCTREOTIDE ACETATE) 500MCG

Toedieningsweg:

INTRAVENOUS

Eenheden in pakket:

100

Prescription-type:

Prescription

Therapeutisch gebied:

MISCELLANEOUS THERAPEUTIC AGENTS

Product samenvatting:

Active ingredient group (AIG) number: 0121548002; AHFS:

Autorisatie-status:

CANCELLED PRE MARKET

Autorisatie datum:

2019-08-01

Productkenmerken

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_Page 1 of 41_
PRODUCT MONOGRAPH
PR
OCTREOTIDE ACETATE INJECTION
(Octreotide acetate Injection)
50 µg/ mL, 100 µg/ mL, 200 µg/ mL, 500 µg/ mL
SYNTHETIC OCTAPEPTIDE ANALOGUE OF SOMATOSTATIN
Sandoz Canada Inc.
145 Jules-Léger
Boucherville, QC
J4B 7K8
Date of Revision:
April 20, 2018
Submission Control No: 214800
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_Page 2 of 41_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
....................................................................................................9
DRUG INTERACTIONS
..................................................................................................16
DOSAGE AND ADMINISTRATION
..............................................................................17
OVERDOSAGE
................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND STABILITY
..........................................................................................20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................21
PART II: SCIENTIFIC INFORMATION
...............................................................................22
PHARMACEUTICAL INFORMATION
..........................................................................22
CLINICAL TRIALS
..........................................................................................................23
DETAILED PHARMACOLOGY
........