JAMP-TERBINAFINE TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

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Download Ciri produk (SPC)
23-09-2010

Bahan aktif:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE)

Boleh didapati daripada:

JAMP PHARMA CORPORATION

Kod ATC:

D01BA02

INN (Nama Antarabangsa):

TERBINAFINE

Dos:

250MG

Borang farmaseutikal:

TABLET

Komposisi:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 250MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

30/100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

ALLYLAMINES

Ringkasan produk:

Active ingredient group (AIG) number: 0132855002; AHFS:

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2022-09-07

Ciri produk

                                Page 1 of 33
PRODUCT MONOGRAPH
PR
JAMP-TERBINAFINE
Terbinafine Tablets
(250 mg Terbinafine as Terbinafine Hydrochloride)
ANTIFUNGAL AGENT
JAMP PHARMA CORPORATION
DATE OF PREPARATION:
1380 – 203 Newton Street
September 16, 2010
Boucherville, Quebec
J4B 5H2
Control#: 141429
Page 2 of 33
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
SUMMARY PRODUCT INFORMATION
...............................................................................3
INDICATIONS AND CLINICAL
USE.....................................................................................3
CONTRAINDICATIONS
..........................................................................................................4
WARNINGS AND
PRECAUTIONS.........................................................................................4
ADVERSE
REACTIONS...........................................................................................................6
DRUG INTERACTIONS
...........................................................................................................8
DOSAGE AND
ADMINISTRATION.......................................................................................9
OVERDOSAGE
.......................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
...................................................................10
STORAGE AND
STABILITY.................................................................................................12
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................12
PART II: SCIENTIFIC INFORMATION
...............................................................................13
PHARMACEUTICAL
INFORMATION.................................................................................13
CLINICAL
TRIALS.................................................................................................................14
DETAI
                                
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