OCTREOTIDE ACETATE OMEGA SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

OCTREOTIDE (OCTREOTIDE ACETATE)

Saatavilla:

OMEGA LABORATORIES LIMITED

ATC-koodi:

H01CB02

INN (Kansainvälinen yleisnimi):

OCTREOTIDE

Annos:

200MCG

Lääkemuoto:

SOLUTION

Koostumus:

OCTREOTIDE (OCTREOTIDE ACETATE) 200MCG

Antoreitti:

INTRAVENOUS

Kpl paketissa:

5ML

Prescription tyyppi:

Prescription

Terapeuttinen alue:

MISCELLANEOUS THERAPEUTIC AGENTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0121548003; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2004-01-05

Valmisteyhteenveto

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