OCTREOTIDE FOR INJECTABLE SUSPENSION POWDER FOR SUSPENSION, SUSTAINED-RELEASE

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

OCTREOTIDE (OCTREOTIDE ACETATE)

Prieinama:

TEVA CANADA LIMITED

ATC kodas:

H01CB02

INN (Tarptautinis Pavadinimas):

OCTREOTIDE

Dozė:

20MG

Vaisto forma:

POWDER FOR SUSPENSION, SUSTAINED-RELEASE

Sudėtis:

OCTREOTIDE (OCTREOTIDE ACETATE) 20MG

Vartojimo būdas:

INTRAMUSCULAR

Vienetai pakuotėje:

15G/50G

Recepto tipas:

Prescription

Gydymo sritis:

MISCELLANEOUS THERAPEUTIC AGENTS

Produkto santrauka:

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

Autorizacija statusas:

APPROVED

Leidimo data:

2020-08-19

Prekės savybės

_OCTREOTIDE for INJECTABLE SUSPENSION _
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_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.................................