SANDOSTATIN SOLUTION

Երկիր: Կանադա

Լեզու: անգլերեն

Աղբյուրը: Health Canada

Ակտիվ բաղադրիչ:

OCTREOTIDE (OCTREOTIDE ACETATE)

Հասանելի է:

NOVARTIS PHARMACEUTICALS CANADA INC

ATC կոդը:

H01CB02

INN (Միջազգային անվանումը):

OCTREOTIDE

Դոզան:

500MCG

Դեղագործական ձեւ:

SOLUTION

Կազմը:

OCTREOTIDE (OCTREOTIDE ACETATE) 500MCG

Կառավարման երթուղին:

INTRAVENOUS

Միավորները փաթեթում:

1ML

Ռեկվիզորի տեսակը:

Prescription

Թերապեւտիկ տարածք:

MISCELLANEOUS THERAPEUTIC AGENTS

Ապրանքի ամփոփագիր:

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

Լիազորման կարգավիճակը:

CANCELLED POST MARKET

Հաստատման ամսաթիվը:

2018-07-30

Ապրանքի հատկությունները

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