BACLOFEN TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Osta se nyt

Valmisteyhteenveto Valmisteyhteenveto (SPC)
20-08-2014

Aktiivinen ainesosa:

BACLOFEN

Saatavilla:

APOTEX INC

ATC-koodi:

M03BX01

INN (Kansainvälinen yleisnimi):

BACLOFEN

Annos:

20MG

Lääkemuoto:

TABLET

Koostumus:

BACLOFEN 20MG

Antoreitti:

ORAL

Kpl paketissa:

100/250/500/1000

Prescription tyyppi:

Prescription

Terapeuttinen alue:

GABA-DERIVATIVE SKELETAL MUSCLE RELAXANTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0113246002; AHFS:

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2014-08-23

Valmisteyhteenveto

                                Page 1 of 27
PRODUCT MONOGRAPH
BACLOFEN
BACLOFEN TABLETS USP
10 MG AND 20 MG
ANTISPASTIC AGENT
APOTEX INC. DATE OF PREPARATION:
150 SIGNET DRIVE August 18, 2014
TORONTO, ONTARIO
M9L 1T9
Control Number: 176430
Page 2 of 27
TABLE OF CONTENT
THERAPEUTIC CLASSIFICATION
...............................................................................................
3
CLINICAL PHARMACOLOGY
......................................................................................................
3
INDICATIONS
..................................................................................................................................
5
CONTRAINDICATIONS
.................................................................................................................
5
WARNINGS
......................................................................................................................................
5
PRECAUTIONS
................................................................................................................................
7
ADVERSE REACTIONS
................................................................................................................
10
SYMPTOMS AND TREATMENT OF OVERDOSAGE
.............................................................. 13
DOSAGE AND ADMINISTRATION
............................................................................................
14
AVAILABILITY
.............................................................................................................................
15
CHEMISTRY AND PHARMACOLOGY
......................................................................................
17
TOXICOLOGY
...............................................................................................................................
18
TERATOLOGY AND REPRODUCTION STUDIES
....................................................................
20
SELECTED BIBLIOGRAPHY
...................................................................................................
                                
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