BACLOFEN TABLET
Negara: Kanada
Bahasa: Inggris
Sumber: Health Canada
Karakteristik produk
(SPC)
20-08-2014
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Bahan aktif:
BACLOFEN
Tersedia dari:
APOTEX INC
Kode ATC:
M03BX01
INN (Nama Internasional):
BACLOFEN
Dosis:
10MG
Bentuk farmasi:
TABLET
Komposisi:
BACLOFEN 10MG
Rute administrasi :
ORAL
Unit dalam paket:
100/250/500/1000
Jenis Resep:
Prescription
Area terapi:
GABA-DERIVATIVE SKELETAL MUSCLE RELAXANTS
Ringkasan produk:
Active ingredient group (AIG) number: 0113246001; AHFS:
Status otorisasi:
CANCELLED POST MARKET
Tanggal Otorisasi:
2014-08-23
Karakteristik produk
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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