OCTREOTIDE ACETATE INJECTION SOLUTION

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

OCTREOTIDE (OCTREOTIDE ACETATE)

Prieinama:

GENERIC MEDICAL PARTNERS INC

ATC kodas:

H01CB02

INN (Tarptautinis Pavadinimas):

OCTREOTIDE

Dozė:

50MCG

Vaisto forma:

SOLUTION

Sudėtis:

OCTREOTIDE (OCTREOTIDE ACETATE) 50MCG

Vartojimo būdas:

INTRAVENOUS

Vienetai pakuotėje:

100

Recepto tipas:

Prescription

Gydymo sritis:

MISCELLANEOUS THERAPEUTIC AGENTS

Produkto santrauka:

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

Autorizacija statusas:

APPROVED

Leidimo data:

2020-12-17

Prekės savybės

_Pr_
_Octreotide Acetate Injection _
_ _
_ _
_ _
_ _
_ _
_ _
_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
...........................................................