OCTREOTIDE FOR INJECTABLE SUSPENSION POWDER FOR SUSPENSION, SUSTAINED-RELEASE

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

OCTREOTIDE (OCTREOTIDE ACETATE)

Inapatikana kutoka:

TEVA CANADA LIMITED

ATC kanuni:

H01CB02

INN (Jina la Kimataifa):

OCTREOTIDE

Kipimo:

20MG

Dawa fomu:

POWDER FOR SUSPENSION, SUSTAINED-RELEASE

Tungo:

OCTREOTIDE (OCTREOTIDE ACETATE) 20MG

Njia ya uendeshaji:

INTRAMUSCULAR

Vitengo katika mfuko:

15G/50G

Dawa ya aina:

Prescription

Eneo la matibabu:

MISCELLANEOUS THERAPEUTIC AGENTS

Bidhaa muhtasari:

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

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2020-08-19

Tabia za bidhaa

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