OCTREOTIDE ACETATE INJECTION - 200MCG/ML SOLUTION

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

OCTREOTIDE (OCTREOTIDE ACETATE)

متاح من:

SANDOZ CANADA INCORPORATED

ATC رمز:

H01CB02

INN (الاسم الدولي):

OCTREOTIDE

جرعة:

200MCG

الشكل الصيدلاني:

SOLUTION

تركيب:

OCTREOTIDE (OCTREOTIDE ACETATE) 200MCG

طريقة التعاطي:

INTRAVENOUS

الوحدات في الحزمة:

100

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

MISCELLANEOUS THERAPEUTIC AGENTS

ملخص المنتج:

Active ingredient group (AIG) number: 0121548003; AHFS:

الوضع إذن:

CANCELLED PRE MARKET

تاريخ الترخيص:

2019-08-01

خصائص المنتج

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_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
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_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
........