SANDOSTATIN SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

OCTREOTIDE (OCTREOTIDE ACETATE)

זמין מ:

NOVARTIS PHARMACEUTICALS CANADA INC

קוד ATC:

H01CB02

INN (שם בינלאומי):

OCTREOTIDE

כמות:

500MCG

טופס פרצבטיות:

SOLUTION

הרכב:

OCTREOTIDE (OCTREOTIDE ACETATE) 500MCG

מסלול נתינה (של תרופות):

INTRAVENOUS

יחידות באריזה:

1ML

סוג מרשם:

Prescription

איזור תרפויטי:

MISCELLANEOUS THERAPEUTIC AGENTS

leaflet_short:

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

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2018-07-30

מאפייני מוצר

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