OCTREOTIDE INJECTION SOLUTION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

OCTREOTIDE (OCTREOTIDE ACETATE)

から入手可能:

MONT-PHARMA INC

ATCコード:

H01CB02

INN（国際名）:

OCTREOTIDE

投薬量:

50MCG

医薬品形態:

SOLUTION

構図:

OCTREOTIDE (OCTREOTIDE ACETATE) 50MCG

投与経路:

INTRAVENOUS

パッケージ内のユニット:

100

処方タイプ:

Prescription

製品概要:

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

認証ステータス:

APPROVED

承認日:

2023-03-07

製品の特徴

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