SANDOSTATIN SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

OCTREOTIDE (OCTREOTIDE ACETATE)

Sẵn có từ:

NOVARTIS PHARMACEUTICALS CANADA INC

Mã ATC:

H01CB02

INN (Tên quốc tế):

OCTREOTIDE

Liều dùng:

500MCG

Dạng dược phẩm:

SOLUTION

Thành phần:

OCTREOTIDE (OCTREOTIDE ACETATE) 500MCG

Tuyến hành chính:

INTRAVENOUS

Các đơn vị trong gói:

1ML

Loại thuốc theo toa:

Prescription

Khu trị liệu:

MISCELLANEOUS THERAPEUTIC AGENTS

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

CANCELLED POST MARKET

Ngày ủy quyền:

2018-07-30

Đặc tính sản phẩm

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