OCTREOTIDE ACETATE INJECTION - 100MCG/ML SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

OCTREOTIDE (OCTREOTIDE ACETATE)

Tilgjengelig fra:

SANDOZ CANADA INCORPORATED

ATC-kode:

H01CB02

INN (International Name):

OCTREOTIDE

Dosering :

100MCG

Legemiddelform:

SOLUTION

Sammensetning:

OCTREOTIDE (OCTREOTIDE ACETATE) 100MCG

Administreringsrute:

INTRAVENOUS

Enheter i pakken:

100

Resept typen:

Prescription

Terapeutisk område:

MISCELLANEOUS THERAPEUTIC AGENTS

Produkt oppsummering:

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

Autorisasjon status:

CANCELLED PRE MARKET

Autorisasjon dato:

2019-08-01

Preparatomtale

_ _
_ _
_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
_ _
_ _
_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
........