ABLAVAR SOLUTION

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

GADOFOSVESET TRISODIUM

Saadav alates:

LANTHEUS MI CANADA INC

ATC kood:

V08CA11

INN (Rahvusvaheline Nimetus):

GADOFOSVESET

Annus:

244MG

Ravimvorm:

SOLUTION

Koostis:

GADOFOSVESET TRISODIUM 244MG

Manustamisviis:

INTRAVENOUS

Ühikuid pakis:

100

Retsepti tüüp:

Ethical

Terapeutiline ala:

OTHER DIAGNOSTIC AGENTS

Toote kokkuvõte:

Active ingredient group (AIG) number: 0151671001; AHFS:

Volitamisolek:

CANCELLED POST MARKET

Loa andmise kuupäev:

2016-03-07

Toote omadused

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PRODUCT MONOGRAPH
ABLAVAR
TM
(gadofosveset trisodium injection)
244 mg/mL (0.25mmol/mL)
INTRAVENOUS CONTRAST ENHANCEMENT AGENT FOR MAGNETIC RESONANCE IMAGING
(MRI)
FOR INTRAVENOUS USE
Lantheus MI Canada, Inc.
1111 Dr. Frederik-Philips Boulevard
Montreal, QC Canada
Control No.: 176017
Date of Revision:
October 1, 2014
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Page 2 of 46
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................9
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................18
OVERDOSAGE
................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND STABILITY
..........................................................................................22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................22
PART II: SCIENTIFIC INFORMATION
................................................................................24
PHARMACEUTICAL INFORMATION
..........................................................................24
CLINICAL TRIALS
..........................................................................................................25
DETAILED PHARMA