OCTREOTIDE ACETATE OMEGA SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

OCTREOTIDE (OCTREOTIDE ACETATE)

Pieejams no:

OMEGA LABORATORIES LIMITED

ATĶ kods:

H01CB02

SNN (starptautisko nepatentēto nosaukumu):

OCTREOTIDE

Deva:

500MCG

Zāļu forma:

SOLUTION

Kompozīcija:

OCTREOTIDE (OCTREOTIDE ACETATE) 500MCG

Ievadīšanas:

INTRAVENOUS

Vienības iepakojumā:

1ML

Receptes veids:

Prescription

Ārstniecības joma:

MISCELLANEOUS THERAPEUTIC AGENTS

Produktu pārskats:

Active ingredient group (AIG) number: 0121548002; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2004-01-05

Produkta apraksts

1
PRODUCT MONOGRAPH
INCLUDING PATIENT
MEDICATION
INFORMATIO N
Pr
O
CTREOTIDE
A
CETATE
O
MEGA
Octreotide Injection
50 MCG / ML, 100 MCG / ML, 200 MCG / ML, 500 MCG / ML OCTREOTIDE (AS
ACETATE)
Solution
for Subcutaneous injection or intravenous infusion
Synthetic Octapeptide Analogue of Somatostatin
Omega Laboratories Limited
DATE OF INITIAL AUTHORIZATION
11,177 Hamon
February 26, 2004
Montreal, Quebec
DATE OF REVISION:
H3M 3E4
January 25, 2022
SUBMISSION CONTROL NUMBER: 252366
2
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.2 RECOMMENDED DOSE AND DOSAGE
ADJUSTMENT, CARCINOID TUMORS
01/2022
4 DOSAGE AND ADMINISTRATION, 4.3 RECOMMENDED DOSE AND DOSAGE
ADJUSTMENT, RECONSTITUTION, PARENTERAL PRODUCTS
01/2022
7 WARNING AND PRECAUTIONS, HEPATIC/ BILIARY / PANCREATIC
01/2022
7 WARNING AND PRECAUTIONS, MONITORING AND LABORATORY TESTS
01/2022
7 WARNING AND PRECAUTIONS, FERTILITY
01/2022
7 WARNING AND PRECAUTIONS, TERATOGENIC RISK
01/2022
7 WARNING AND PRECAUTIONS, 7.1.4 GERIATRICS
01/2022
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
.........................................................4
1.
INDICATIONS.............................................................................................................4
1.1
Pediatrics...................................................................................................................5
1.2
Geriatrics...................................................................................................................5
2.
CONTRAINDICATIONS..............................................................................................5
4.
DOSAGE AND ADMINISTRATION
....................................................................