OCTREOTIDE ACETATE INJECTION SOLUTION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

OCTREOTIDE (OCTREOTIDE ACETATE)

Disponível em:

GENERIC MEDICAL PARTNERS INC

Código ATC:

H01CB02

DCI (Denominação Comum Internacional):

OCTREOTIDE

Dosagem:

50MCG

Forma farmacêutica:

SOLUTION

Composição:

OCTREOTIDE (OCTREOTIDE ACETATE) 50MCG

Via de administração:

INTRAVENOUS

Unidades em pacote:

100

Tipo de prescrição:

Prescription

Área terapêutica:

MISCELLANEOUS THERAPEUTIC AGENTS

Resumo do produto:

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

Status de autorização:

APPROVED

Data de autorização:

2020-12-17

Características técnicas

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_Octreotide Acetate Injection _
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_Page 1 of 38 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
OCTREOTIDE ACETATE INJECTION
Octreotide acetate injection
50 mcg/mL, 100 mcg/mL, 500 mcg/mL Solution for Subcutaneous injection
or Intravenous
infusion
Synthetic octapeptide analogue of somatostatin (H01CB02)
Generic Medical Partners Inc.
1500 Don Mills Road, Suite 406,
Toronto, Ontario
M3B 3K4
Date of Initial Authorization:
December 16, 2020
Date of Revision:
November 15, 2021
Submission Control Number: 253796
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_Octreotide Acetate Injection _
_Page 2 of 38 _
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment, Carcinoid Tumours
11/2021
7 WARNINGS AND PRECAUTIONS, Fertility
11/2021
7 WARNINGS AND PRECAUTIONS,
Teratogenic Risk
11/2021
7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics
11/2021
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
............................................................... 3
1
INDICATIONS
...............................................................................................................
3
1.1
Pediatrics
................................................................................................................
4
1.2
Geriatrics
.................................................................................................................
4
2
CONTRAINDICATIONS
................................................................................................
4
4
DOSAGE AND
ADMINISTRATION...............................................................................
4
4.1
Dosing Considerations
...........................................................