SANDOSTATIN SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

OCTREOTIDE (OCTREOTIDE ACETATE)

Dostupné s:

NOVARTIS PHARMACEUTICALS CANADA INC

ATC kód:

H01CB02

INN (Mezinárodní Name):

OCTREOTIDE

Dávkování:

500MCG

Léková forma:

SOLUTION

Složení:

OCTREOTIDE (OCTREOTIDE ACETATE) 500MCG

Podání:

INTRAVENOUS

Jednotky v balení:

1ML

Druh předpisu:

Prescription

Terapeutické oblasti:

MISCELLANEOUS THERAPEUTIC AGENTS

Přehled produktů:

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

Stav Autorizace:

CANCELLED POST MARKET

Datum autorizace:

2018-07-30

Charakteristika produktu

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_Page 1 of 61_
PRODUCT MONOGRAPH
PR
SANDOSTATIN
®
(Octreotide acetate Injection)
50 µg/ mL, 100 µg/ mL, 200 µg/ mL, 500 µg/ mL
PR
SANDOSTATIN
® LAR
®
Octreotide (as acetate) for Injectable Suspension
10, 20 or 30 mg octreotide (as acetate) per vial
SYNTHETIC OCTAPEPTIDE ANALOGUE OF SOMATOSTATIN
Novartis Pharmaceuticals Canada Inc.
Dorval, Quebec
H9S 1A9
Date of Preparation:
June 6, 1989
Date of Revision:
January 31, 2018
Submission Control No: 210953
SANDOSTATIN and LAR are registered trademarks
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_Page 2 of 61_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................5
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE REACTIONS
..................................................................................................10
DRUG INTERACTIONS
..................................................................................................20
DOSAGE AND ADMINISTRATION
..............................................................................21
OVERDOSAGE
................................................................................................................31
ACTION AND CLINICAL PHARMACOLOGY
............................................................31
STORAGE AND STABILITY
..........................................................................................33
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................34
PART II: SCIENTIFIC INFORMATION
...............................................................................36
PHARMACEUTICAL INFORMATION
..........................................