OCTREOTIDE FOR INJECTABLE SUSPENSION POWDER FOR SUSPENSION, SUSTAINED-RELEASE

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

OCTREOTIDE (OCTREOTIDE ACETATE)

Tillgänglig från:

TEVA CANADA LIMITED

ATC-kod:

H01CB02

INN (International namn):

OCTREOTIDE

Dos:

20MG

Läkemedelsform:

POWDER FOR SUSPENSION, SUSTAINED-RELEASE

Sammansättning:

OCTREOTIDE (OCTREOTIDE ACETATE) 20MG

Administreringssätt:

INTRAMUSCULAR

Enheter i paketet:

15G/50G

Receptbelagda typ:

Prescription

Terapiområde:

MISCELLANEOUS THERAPEUTIC AGENTS

Produktsammanfattning:

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

Bemyndigande status:

APPROVED

Tillstånd datum:

2020-08-19

Produktens egenskaper

_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 _
_ _
_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.................................