OCTREOTIDE ACETATE OMEGA SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

OCTREOTIDE (OCTREOTIDE ACETATE)

Διαθέσιμο από:

OMEGA LABORATORIES LIMITED

Φαρμακολογική κατηγορία (ATC):

H01CB02

INN (Διεθνής Όνομα):

OCTREOTIDE

Δοσολογία:

200MCG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

OCTREOTIDE (OCTREOTIDE ACETATE) 200MCG

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

5ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

MISCELLANEOUS THERAPEUTIC AGENTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2004-01-05

Αρχείο Π.Χ.Π.

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