PREGABALIN CAPSULE

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

PREGABALIN

Διαθέσιμο από:

RANBAXY PHARMACEUTICALS CANADA INC.

Φαρμακολογική κατηγορία (ATC):

N02BF02

INN (Διεθνής Όνομα):

PREGABALIN

Δοσολογία:

50MG

Φαρμακοτεχνική μορφή:

CAPSULE

Σύνθεση:

PREGABALIN 50MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

MISCELLANEOUS ANTICONVULSANTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0151121002; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2013-11-07

Αρχείο Π.Χ.Π.

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_RAN_
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_-PREGABALIN (Pregabalin Capsules) Product Monograph_
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_Page 1 of 61_
PRODUCT MONOGRAPH
Pr
RAN
™
-PREGABALIN
Pregabalin Capsules
25 mg, 50 mg, 75 mg, 150 mg, 225 mg, 300 mg
ANALGESIC AGENT
Ranbaxy Pharmaceuticals Canada Inc.,
126 East Drive
Brampton, ON
L6T 1C1
Date of Revision:
March 24, 2020
Submission Control No: 237057
RAN trademark owned by Sun Pharmaceutical Industries Ltd.
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_RAN_
_™_
_-PREGABALIN (Pregabalin Capsules) Product Monograph_
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_Page 2 of 61_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
.....................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
.................................................................................................4
ADVERSE REACTIONS
..................................................................................................15
DRUG INTERACTIONS
................................................................................................33
DOSAGE AND ADMINISTRATION
...........................................................................35
OVERDOSAGE
...............................................................................................................37
ACTION AND CLINICAL PHARMACOLOGY
............................................................38
STORAGE AND
STABILITY........................................................................................41
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................41
PART II: SCIENTIFIC INFORMATION
...............................................................................43
PHARMACEUTICAL INFORMATION
..........................................................................43
CLINICAL TRIALS
........................................................................................................44
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