OCTREOTIDE INJECTION SOLUTION

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

OCTREOTIDE (OCTREOTIDE ACETATE)

Fáanlegur frá:

MONT-PHARMA INC

ATC númer:

H01CB02

INN (Alþjóðlegt nafn):

OCTREOTIDE

Skammtar:

200MCG

Lyfjaform:

SOLUTION

Samsetning:

OCTREOTIDE (OCTREOTIDE ACETATE) 200MCG

Stjórnsýsluleið:

INTRAVENOUS

Einingar í pakka:

100

Gerð lyfseðils:

Prescription

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2023-03-07

Vara einkenni

1
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION
INFORMATIO N
PR 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
Mont-Pharma Inc
2379 Rue Guenette
Montreal, Quebec
H4R 2E9
SUBMISSION CONTROL NUMBER: 271522
DATE OF
INITIAL AUTHORIZATION:
MAR 2, 2023
2
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.2 RECOMMENDED DOSE AND DOSAGE
ADJUSTMENT, CARCINOID TUMORS
03/2023
4 DOSAGE AND ADMINISTRATION, 4.3 RECOMMENDED DOSE AND DOSAGE
ADJUSTMENT, RECONSTITUTION, PARENTERAL PRODUCTS
03/2023
7 WARNING AND PRECAUTIONS, HEPATIC/ BILIARY / PANCREATIC
03/2023
7 WARNING AND PRECAUTIONS, MONITORING AND LABORATORY TESTS
03/2023
7 WARNING AND PRECAUTIONS, FERTILITY
03/2023
7 WARNING AND PRECAUTIONS, TERATOGENIC RISK
03/2023
7 WARNING AND PRECAUTIONS, 7.1.4 GERIATRICS
03/2023
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
...............................