BACLOFEN-10 TABLET
Negara: Kanada
Bahasa: Inggris
Sumber: Health Canada
Karakteristik produk
(SPC)
10-03-2021
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Bahan aktif:
BACLOFEN
Tersedia dari:
PRO DOC LIMITEE
Kode ATC:
M03BX01
INN (Nama Internasional):
BACLOFEN
Dosis:
10MG
Bentuk farmasi:
TABLET
Komposisi:
BACLOFEN 10MG
Rute administrasi :
ORAL
Unit dalam paket:
100/500
Jenis Resep:
Prescription
Area terapi:
GABA-DERIVATIVE SKELETAL MUSCLE RELAXANTS
Ringkasan produk:
Active ingredient group (AIG) number: 0113246001; AHFS:
Status otorisasi:
APPROVED
Tanggal Otorisasi:
2019-01-15
Karakteristik produk
Page 1 of 27
PRODUCT MONOGRAPH
PR
BACLOFEN – 10
PR
BACLOFEN – 20
BACLOFEN TABLETS USP
10 MG AND 20 MG
ANTISPASTIC AGENT
PRO DOC LTÉE
DATE OF REVISION:
2925, boul. Industriel
March 10, 2021
Laval, Quebec
H7L 3W9
Control Number: 248887
Page 2 of 27
TABLE OF CONTENT
THERAPEUTIC CLASSIFICATION
...........................................................................................................................
3
CLINICAL PHARMACOLOGY
....................................................................................................................................
3
INDICATIONS
...............................................................................................................................................................
5
CONTRAINDICATIONS
...............................................................................................................................................
5
WARNINGS
...................................................................................................................................................................
5
PRECAUTIONS
............................................................................................................................................................
9
ADVERSE REACTIONS
.............................................................................................................................................12
SYMPTOMS AND TREATMENT OF OVERDOSAGE
..........................................................................................14
DOSAGE AND ADMINISTRATION
..........................................................................................................................15
AVAILABILITY
..............................................................................................................................................................17
CHEMISTRY AND PHARMACOLOGY
....................................................................................................................18
PHARMACOLOGY
.........
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