OCTREOTIDE ACETATE INJECTION SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

OCTREOTIDE (OCTREOTIDE ACETATE)

Dostupné s:

GENERIC MEDICAL PARTNERS INC

ATC kód:

H01CB02

INN (Mezinárodní Name):

OCTREOTIDE

Dávkování:

50MCG

Léková forma:

SOLUTION

Složení:

OCTREOTIDE (OCTREOTIDE ACETATE) 50MCG

Podání:

INTRAVENOUS

Jednotky v balení:

100

Druh předpisu:

Prescription

Terapeutické oblasti:

MISCELLANEOUS THERAPEUTIC AGENTS

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2020-12-17

Charakteristika produktu

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