OCTREOTIDE ACETATE INJECTION SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

OCTREOTIDE (OCTREOTIDE ACETATE)

Disponible depuis:

GENERIC MEDICAL PARTNERS INC

Code ATC:

H01CB02

DCI (Dénomination commune internationale):

OCTREOTIDE

Dosage:

50MCG

forme pharmaceutique:

SOLUTION

Composition:

OCTREOTIDE (OCTREOTIDE ACETATE) 50MCG

Mode d'administration:

INTRAVENOUS

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

MISCELLANEOUS THERAPEUTIC AGENTS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2020-12-17

Résumé des caractéristiques du produit

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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
_Pr_
_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
...........................................................