OCTREOTIDE INJECTION SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

OCTREOTIDE (OCTREOTIDE ACETATE)

Διαθέσιμο από:

TEVA CANADA 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: 0121548010; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2018-06-21

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
PR
OCTREOTIDE INJECTION
(Octreotide as acetate)
Single Dose Vials (1 mL)
50 µg/mL, 100 µg/mL, 500 µg/mL
Multidose Vials (5 mL)
200 µg/mL
STERILE
SYNTHETIC OCTAPEPTIDE ANALOGUE OF SOMATOSTATIN
Teva Canada Limited
Date of Preparation:
30 Novopharm Court
March 28, 2014
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Submission Control No.: 172353
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
5
WARNINGS AND PRECAUTIONS
.........................................................................................
5
ADVERSE REACTIONS
...........................................................................................................
9
DRUG INTERACTIONS
.........................................................................................................
14
DOSAGE AND ADMINISTRATION
.....................................................................................
15
OVERDOSAGE
.......................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 18
STORAGE AND STABILITY
.................................................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 19
PART II: SCIENTIFIC INFORMATION
...............................................................................
21
PHARMACEUTICAL INFORMATION
.................................................................................
21
DETAILED PHARMACOLOGY
..........