RATIO-VALPROIC CAPSULE (ENTERIC-COATED)
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:
TEVA CANADA LIMITED
ATC númer:
N03AG01
INN (Alþjóðlegt nafn):
VALPROIC ACID
Skammtar:
500MG
Lyfjaform:
CAPSULE (ENTERIC-COATED)
Samsetning:
VALPROIC ACID 500MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
100/500
Gerð lyfseðils:
Prescription
Lækningarsvæði:
MISCELLANEOUS ANTICONVULSANTS
Vörulýsing:
Active ingredient group (AIG) number: 0112996003; AHFS:
Leyfisstaða:
MARKETED
Leyfisdagur:
2007-07-13
Vara einkenni
PRODUCT MONOGRAPH
PR
RATIO-VALPROIC
(VALPROIC ACID)
Capsules
Capsules (250 mg and 500 mg)
USP
Antiepileptic
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Date of Preparation :
July 24, 2013
Submission Control No: 166248
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
.................................................................................................................
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