MYL-DIVALPROEX TABLET (DELAYED-RELEASE)

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

VALPROIC ACID (DIVALPROEX SODIUM)

Dostupné z:

MYLAN PHARMACEUTICALS ULC

ATC kód:

N03AG01

INN (Medzinárodný Name):

VALPROIC ACID

Dávkovanie:

125MG

Forma lieku:

TABLET (DELAYED-RELEASE)

Zloženie:

VALPROIC ACID (DIVALPROEX SODIUM) 125MG

Spôsob podávania:

ORAL

Počet v balení:

100

Typ predpisu:

Prescription

Terapeutické oblasti:

MISCELLANEOUS ANTICONVULSANTS

Prehľad produktov:

Active ingredient group (AIG) number: 0112996004; AHFS:

Stav Autorizácia:

CANCELLED POST MARKET

Dátum Autorizácia:

2017-01-11

Súhrn charakteristických

PRODUCT MONOGRAPH
PR
MYL-DIVALPROEX
Divalproex Sodium Delayed-Release Tablets, USP
125 mg, 250 mg, 500 mg valproic acid (as divalproex sodium)
Anticonvulsant
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Control Number: 197330
Date of Revision:
September 08, 2016
_Page 2 of 47_
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
.........................................................................................................
21
DRUG
INTERACTIONS
.........................................................................................................
29
DOSAGE
AND
ADMINISTRATION
.....................................................................................
37
OVERDOSAGE
.......................................................................................................................
40
ACTION
AND
CLINICAL
PHARMACOLOGY
....................................................................
40
STORAGE
AND
STABILITY
.................................................................................................
43
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ..................................................... 44
PART II: SCIENTIFIC INFORMATION
...............................................................................
45
PHARMACEUTICAL
INFORMATION
.................................................................................
45
CLINICAL
TRIALS
.....................................................................................