GABAPENTIN CAPSULES

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

GABAPENTIN

Διαθέσιμο από:

RANBAXY PHARMACEUTICALS CANADA INC.

Φαρμακολογική κατηγορία (ATC):

N02BF01

INN (Διεθνής Όνομα):

GABAPENTIN

Δοσολογία:

300MG

Φαρμακοτεχνική μορφή:

CAPSULE

Σύνθεση:

GABAPENTIN 300MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

30/100/500

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

MISCELLANEOUS ANTICONVULSANTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0125929003; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED PRE MARKET

Ημερομηνία της άδειας:

2023-07-24

Αρχείο Π.Χ.Π.

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_Page 1 of 28_
PRODUCT MONOGRAPH
PR
GABAPENTIN CAPSULES
Gabapentin Capsules USP
100 mg, 300 mg, and 400 mg
Antiepileptic Agent
Ranbaxy Pharmaceuticals Canada Inc., Date of Preparation: August 20,
2009.
2680 Matheson Blvd. E., Suite 200
Mississauga, Ontario
L4W 0A5
Submission Control No: 132106
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_Page 2 of 28_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION..............................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
CONTRAINDICATIONS
....…...........................................................................................3
WARNINGS AND
PRECAUTIONS..................................................................................3
ADVERSE
REACTIONS....................................................................................................5
DRUG INTERACTIONS
..................................................................................................11
DOSAGE AND
ADMINISTRATION..............................................................................13
OVERDOSAGE
................................................................................................................15
ACTION AND CLINICAL PHARMACOLOGY
............................................................15
STORAGE AND
STABILITY..........................................................................................18
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................18
PART II: SCIENTIFIC INFORMATION
....................................................................20
PHARMACEUTICAL
INFORMATION..........................................................................20
CLINICAL
TRIALS..........................................................................................................21
DETAILED
PHARMACOLOGY..............................................................