OCPHYL SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

OCTREOTIDE (OCTREOTIDE ACETATE)

זמין מ:

PENDOPHARM DIVISION OF PHARMASCIENCE INC

קוד ATC:

H01CB02

INN (שם בינלאומי):

OCTREOTIDE

כמות:

500MCG

טופס פרצבטיות:

SOLUTION

הרכב:

OCTREOTIDE (OCTREOTIDE ACETATE) 500MCG

מסלול נתינה (של תרופות):

INTRAVENOUS

יחידות באריזה:

5

סוג מרשם:

Prescription

איזור תרפויטי:

MISCELLANEOUS THERAPEUTIC AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0121548011; AHFS:

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2018-06-14

מאפייני מוצר

PRODUCT MONOGRAPH
PR
OCPHYL
TM
(Octreotide Injection)
50
g/mL, 100
g/mL and 500
g/mL
octreotide (as octreotide acetate) per 1 mL pre-filled syringe
STERILE
SYNTHETIC OCTAPEPTIDE ANALOGUE OF SOMATOSTATIN
PENDOPHARM, DIVISION OF PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montreal, QC, Canada
H4P 2T4
Date of Preparation:
May 22, 2014
Control No: 173385
_ _
_OCPHYL - Product Monograph _
_Page 2 of 39 _
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
.................................................................................................
16
DOSAGE AND ADMINISTRATION
.............................................................................
18
OVERDOSAGE
................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 20
STORAGE AND STABILITY
.........................................................................................
21
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................. 21
PART II: SCIENTIFIC INFORMATION
..............................................................................
22
PHARMACEUTICAL INFORMATION
.........................................................................
22
DETAILED PHARMACOLOGY
....................................................................