OCTREOTIDE FOR INJECTABLE SUSPENSION POWDER FOR SUSPENSION, SUSTAINED-RELEASE

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:

TEVA CANADA LIMITED

ATCコード:

H01CB02

INN（国際名）:

OCTREOTIDE

投薬量:

20MG

医薬品形態:

POWDER FOR SUSPENSION, SUSTAINED-RELEASE

構図:

OCTREOTIDE (OCTREOTIDE ACETATE) 20MG

投与経路:

INTRAMUSCULAR

パッケージ内のユニット:

15G/50G

処方タイプ:

Prescription

治療領域:

MISCELLANEOUS THERAPEUTIC AGENTS

製品概要:

Active ingredient group (AIG) number: 0121548006; AHFS:

認証ステータス:

APPROVED

承認日:

2020-08-19

製品の特徴

_OCTREOTIDE for INJECTABLE SUSPENSION _
_ _
_Page 1 of 47 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
OCTREOTIDE FOR INJECTABLE SUSPENSION
Octreotide for Injectable Suspension
Powder 10 mg, 20 mg, 30 mg octreotide (as acetate) per vial
Intramuscular injection
Synthetic octapeptide analogue of somatostatin (H01CB02)
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Date of Initial Authorization:
AUG 17, 2020
Date of Revision:
AUG 30, 2021
Submission Control No: 251358
_OCTREOTIDE for INJECTABLE SUSPENSION _
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_Page 2 of 47 _
RECENT MAJOR LABEL CHANGES
7 WARNING AND PRECAUTIONS, Hepatic/Biliary/Pancreatic
08/2021
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....................................................................................................................
4
1.2
Geriatrics
....................................................................................................................
4
2
CONTRAINDICATIONS
......................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.......................................................................................
5
4.1
Dosing Considerations
..................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.................................................................. 5
4.4
Administration.................................