DOM-VALPROIC ACID SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

VALPROIC ACID (SODIUM VALPROATE)

Διαθέσιμο από:

DOMINION PHARMACAL

Φαρμακολογική κατηγορία (ATC):

N03AG01

INN (Διεθνής Όνομα):

VALPROIC ACID

Δοσολογία:

250MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

VALPROIC ACID (SODIUM VALPROATE) 250MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

450ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

MISCELLANEOUS ANTICONVULSANTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0112996002; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

1998-10-06

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
PR
DOM-VALPROIC ACID
Valproic Acid Capsules, USP
250 mg
PR
DOM-VALPROIC ACID E.C.
Valproic Acid Enteric Coated Capsules
500 mg
PR
DOM-VALPROIC ACID
Valproic Acid Oral Solution, USP
250 mg /5 mL
ANTIEPILEPTIC
DOMINION PHARMACAL DATE OF REVISION:
6111 Royalmount Avenue, suite 100 May 12, 2017
Montréal, Quebec
H4P 2T4
SUBMISSION CONTROL NO.: 204664
_ _
_Monographie de produit Dom-VALPROIC ACID & Dom-VALPROIC ACID E.C. _
_Page 2 de 61 _
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
.................................................................................................
26
DOSAGE AND ADMINISTRATION
.............................................................................
34
OVERDOSAGE
................................................................................................................
36
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 37
STORAGE AND STABILITY
.........................................................................................
39
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 40
PART II: SCIENTIFIC INFORMATION
.............................................................................
41
PHARMACEUTICAL INFORMATION
.........................................................................
41
CLINICAL TRIALS
............................