OCTREOTIDE ACETATE OMEGA SOLUTION

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

OCTREOTIDE (OCTREOTIDE ACETATE)

متاح من:

OMEGA LABORATORIES LIMITED

ATC رمز:

H01CB02

INN (الاسم الدولي):

OCTREOTIDE

جرعة:

50MCG

الشكل الصيدلاني:

SOLUTION

تركيب:

OCTREOTIDE (OCTREOTIDE ACETATE) 50MCG

طريقة التعاطي:

INTRAVENOUS

الوحدات في الحزمة:

1ML

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

MISCELLANEOUS THERAPEUTIC AGENTS

ملخص المنتج:

Active ingredient group (AIG) number: 0121548004; AHFS:

الوضع إذن:

APPROVED

تاريخ الترخيص:

2004-01-05

خصائص المنتج

1
PRODUCT MONOGRAPH
INCLUDING PATIENT
MEDICATION
INFORMATIO N
Pr
O
CTREOTIDE
A
CETATE
O
MEGA
Octreotide Injection
50 MCG / ML, 100 MCG / ML, 200 MCG / ML, 500 MCG / ML OCTREOTIDE (AS
ACETATE)
Solution
for Subcutaneous injection or intravenous infusion
Synthetic Octapeptide Analogue of Somatostatin
Omega Laboratories Limited
DATE OF INITIAL AUTHORIZATION
11,177 Hamon
February 26, 2004
Montreal, Quebec
DATE OF REVISION:
H3M 3E4
January 25, 2022
SUBMISSION CONTROL NUMBER: 252366
2
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.2 RECOMMENDED DOSE AND DOSAGE
ADJUSTMENT, CARCINOID TUMORS
01/2022
4 DOSAGE AND ADMINISTRATION, 4.3 RECOMMENDED DOSE AND DOSAGE
ADJUSTMENT, RECONSTITUTION, PARENTERAL PRODUCTS
01/2022
7 WARNING AND PRECAUTIONS, HEPATIC/ BILIARY / PANCREATIC
01/2022
7 WARNING AND PRECAUTIONS, MONITORING AND LABORATORY TESTS
01/2022
7 WARNING AND PRECAUTIONS, FERTILITY
01/2022
7 WARNING AND PRECAUTIONS, TERATOGENIC RISK
01/2022
7 WARNING AND PRECAUTIONS, 7.1.4 GERIATRICS
01/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
.................................................................................2
TABLE OF CONTENTS
......................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................4
1.
INDICATIONS.............................................................................................................4
1.1
Pediatrics...................................................................................................................5
1.2
Geriatrics...................................................................................................................5
2.
CONTRAINDICATIONS..............................................................................................5
4.
DOSAGE AND ADMINISTRATION
....................................................................