RATIO-VALPROIC-CAP 250MG CAPSULE
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
12-10-2016
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
VALPROIC ACID
Fáanlegur frá:
RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED
ATC númer:
N03AG01
INN (Alþjóðlegt nafn):
VALPROIC ACID
Skammtar:
250MG
Lyfjaform:
CAPSULE
Samsetning:
VALPROIC ACID 250MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
100/500
Gerð lyfseðils:
Prescription
Lækningarsvæði:
MISCELLANEOUS ANTICONVULSANTS
Vörulýsing:
Active ingredient group (AIG) number: 0112996001; AHFS:
Leyfisstaða:
CANCELLED POST MARKET
Leyfisdagur:
2014-09-19
Vara einkenni
PRODUCT MONOGRAPH
PR
RATIO-VALPROIC
(VALPROIC ACID)
Capsules
Capsules (250 mg and 500 mg)
USP
Antiepileptic
Ratiopharm Inc.
Date of Revision:
17 800 Lapointe
March 8, 2012
Mirabel, Quebec
Canada J7J 1P3
Control No.: 152387
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.............................................................. 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL
USE.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND
PRECAUTIONS.........................................................................................
5
ADVERSE
REACTIONS.........................................................................................................
16
DRUG INTERACTIONS
.........................................................................................................
19
DOSAGE AND
ADMINISTRATION.....................................................................................
26
OVERDOSAGE
.......................................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 29
STORAGE AND
STABILITY.................................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 32
PART II: SCIENTIFIC
INFORMATION....................................................................................
33
PHARMACEUTICAL
INFORMATION.................................................................................
33
CLINICAL
TRIALS.................................................................................................................
34
DETAILED
PHARMACOLOGY.........................
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