OCTREOTIDE ACETATE INJECTION - 50MCG/ML SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

OCTREOTIDE (OCTREOTIDE ACETATE)

Disponibil de la:

SANDOZ CANADA INCORPORATED

Codul ATC:

H01CB02

INN (nume internaţional):

OCTREOTIDE

Dozare:

50MCG

Forma farmaceutică:

SOLUTION

Compoziție:

OCTREOTIDE (OCTREOTIDE ACETATE) 50MCG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

MISCELLANEOUS THERAPEUTIC AGENTS

Rezumat produs:

Active ingredient group (AIG) number: 0121548004; AHFS:

Statutul autorizaţiei:

CANCELLED PRE MARKET

Data de autorizare:

2019-08-01

Caracteristicilor produsului

_ _
_ _
_Page 1 of 41_
PRODUCT MONOGRAPH
PR
OCTREOTIDE ACETATE INJECTION
(Octreotide acetate Injection)
50 µg/ mL, 100 µg/ mL, 200 µg/ mL, 500 µg/ mL
SYNTHETIC OCTAPEPTIDE ANALOGUE OF SOMATOSTATIN
Sandoz Canada Inc.
145 Jules-Léger
Boucherville, QC
J4B 7K8
Date of Revision:
April 20, 2018
Submission Control No: 214800
_ _
_ _
_Page 2 of 41_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
....................................................................................................9
DRUG INTERACTIONS
..................................................................................................16
DOSAGE AND ADMINISTRATION
..............................................................................17
OVERDOSAGE
................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND STABILITY
..........................................................................................20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................21
PART II: SCIENTIFIC INFORMATION
...............................................................................22
PHARMACEUTICAL INFORMATION
..........................................................................22
CLINICAL TRIALS
..........................................................................................................23
DETAILED PHARMACOLOGY
........