OCTREOTIDE ACETATE INJECTION - 100MCG/ML SOLUTION

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

OCTREOTIDE (OCTREOTIDE ACETATE)

Tillgänglig från:

SANDOZ CANADA INCORPORATED

ATC-kod:

H01CB02

INN (International namn):

OCTREOTIDE

Dos:

100MCG

Läkemedelsform:

SOLUTION

Sammansättning:

OCTREOTIDE (OCTREOTIDE ACETATE) 100MCG

Administreringssätt:

INTRAVENOUS

Enheter i paketet:

100

Receptbelagda typ:

Prescription

Terapiområde:

MISCELLANEOUS THERAPEUTIC AGENTS

Produktsammanfattning:

Active ingredient group (AIG) number: 0121548001; AHFS:

Bemyndigande status:

CANCELLED PRE MARKET

Tillstånd datum:

2019-08-01

Produktens egenskaper

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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
........