OCTREOTIDE ACETATE INJECTION - 100MCG/ML SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

OCTREOTIDE (OCTREOTIDE ACETATE)

Disponible depuis:

SANDOZ CANADA INCORPORATED

Code ATC:

H01CB02

DCI (Dénomination commune internationale):

OCTREOTIDE

Dosage:

100MCG

forme pharmaceutique:

SOLUTION

Composition:

OCTREOTIDE (OCTREOTIDE ACETATE) 100MCG

Mode d'administration:

INTRAVENOUS

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

MISCELLANEOUS THERAPEUTIC AGENTS

Descriptif du produit:

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

Statut de autorisation:

CANCELLED PRE MARKET

Date de l'autorisation:

2019-08-01

Résumé des caractéristiques du produit

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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
........