OCTREOTIDE INJECTION SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

OCTREOTIDE (OCTREOTIDE ACETATE)

Διαθέσιμο από:

MONT-PHARMA INC

Φαρμακολογική κατηγορία (ATC):

H01CB02

INN (Διεθνής Όνομα):

OCTREOTIDE

Δοσολογία:

200MCG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

OCTREOTIDE (OCTREOTIDE ACETATE) 200MCG

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Prescription

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2023-03-07

Αρχείο Π.Χ.Π.

1
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION
INFORMATIO N
PR 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
Mont-Pharma Inc
2379 Rue Guenette
Montreal, Quebec
H4R 2E9
SUBMISSION CONTROL NUMBER: 271522
DATE OF
INITIAL AUTHORIZATION:
MAR 2, 2023
2
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.2 RECOMMENDED DOSE AND DOSAGE
ADJUSTMENT, CARCINOID TUMORS
03/2023
4 DOSAGE AND ADMINISTRATION, 4.3 RECOMMENDED DOSE AND DOSAGE
ADJUSTMENT, RECONSTITUTION, PARENTERAL PRODUCTS
03/2023
7 WARNING AND PRECAUTIONS, HEPATIC/ BILIARY / PANCREATIC
03/2023
7 WARNING AND PRECAUTIONS, MONITORING AND LABORATORY TESTS
03/2023
7 WARNING AND PRECAUTIONS, FERTILITY
03/2023
7 WARNING AND PRECAUTIONS, TERATOGENIC RISK
03/2023
7 WARNING AND PRECAUTIONS, 7.1.4 GERIATRICS
03/2023
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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................. 4
1.
INDICATIONS
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4
1.1
Pediatrics
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5
1.2
Geriatrics
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5
2.
CONTRAINDICATIONS
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5
4.
DOSAGE AND ADMINISTRATION
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