OCTREOTIDE ACETATE INJECTION - 100MCG/ML SOLUTION

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

OCTREOTIDE (OCTREOTIDE ACETATE)

Disponible desde:

SANDOZ CANADA INCORPORATED

Código ATC:

H01CB02

Designación común internacional (DCI):

OCTREOTIDE

Dosis:

100MCG

formulario farmacéutico:

SOLUTION

Composición:

OCTREOTIDE (OCTREOTIDE ACETATE) 100MCG

Vía de administración:

INTRAVENOUS

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

MISCELLANEOUS THERAPEUTIC AGENTS

Resumen del producto:

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

Estado de Autorización:

CANCELLED PRE MARKET

Fecha de autorización:

2019-08-01

Ficha técnica

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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
........