SANDOSTATIN SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

OCTREOTIDE (OCTREOTIDE ACETATE)

Dostopno od:

NOVARTIS PHARMACEUTICALS CANADA INC

Koda artikla:

H01CB02

INN (mednarodno ime):

OCTREOTIDE

Odmerek:

500MCG

Farmacevtska oblika:

SOLUTION

Sestava:

OCTREOTIDE (OCTREOTIDE ACETATE) 500MCG

Pot uporabe:

INTRAVENOUS

Enote v paketu:

1ML

Tip zastaranja:

Prescription

Terapevtsko območje:

MISCELLANEOUS THERAPEUTIC AGENTS

Povzetek izdelek:

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

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2018-07-30

Lastnosti izdelka

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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
..........................................