MYLAN-VALPROIC CAPSULE

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

VALPROIC ACID

Dostopno od:

MYLAN PHARMACEUTICALS ULC

Koda artikla:

N03AG01

INN (mednarodno ime):

VALPROIC ACID

Odmerek:

250MG

Farmacevtska oblika:

CAPSULE

Sestava:

VALPROIC ACID 250MG

Pot uporabe:

ORAL

Enote v paketu:

100/500

Tip zastaranja:

Prescription

Terapevtsko območje:

MISCELLANEOUS ANTICONVULSANTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0112996001; AHFS:

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2016-06-28

Lastnosti izdelka

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PRODUCT MONOGRAPH
PR
MYLAN-VALPROIC
Valproic Acid Capsules, USP
250 mg
Antiepileptic
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke Ontario
M8Z 2S6
Date of Revision: May 7, 2015
Submission Control No.: 184065
2
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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
...........................................................................................................
20
DRUG INTERACTIONS
...........................................................................................................
24
DOSAGE AND ADMINISTRATION
......................................................................................
34
OVERDOSAGE
..........................................................................................................................
37
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
37
STORAGE AND STABILITY
...................................................................................................
40
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 40
PART II: SCIENTIFIC INFORMATION ...................................................................................
41
PHARMACEUTICAL INFORMATION
..................................................................................
41
CLINICAL TRIALS
.....................................................................................................................
42
DETAILED P