OCTREOTIDE ACETATE INJECTION SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

OCTREOTIDE (OCTREOTIDE ACETATE)

Disponibil de la:

GENERIC MEDICAL PARTNERS INC

Codul ATC:

H01CB02

INN (nume internaţional):

OCTREOTIDE

Dozare:

50MCG

Forma farmaceutică:

SOLUTION

Compoziție:

OCTREOTIDE (OCTREOTIDE ACETATE) 50MCG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

MISCELLANEOUS THERAPEUTIC AGENTS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2020-12-17

Caracteristicilor produsului

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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
...........................................................