GABAPENTIN CAPSULES
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
21-08-2009
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
GABAPENTIN
Fáanlegur frá:
RANBAXY PHARMACEUTICALS CANADA INC.
ATC númer:
N02BF01
INN (Alþjóðlegt nafn):
GABAPENTIN
Skammtar:
300MG
Lyfjaform:
CAPSULE
Samsetning:
GABAPENTIN 300MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
30/100/500
Gerð lyfseðils:
Prescription
Lækningarsvæði:
MISCELLANEOUS ANTICONVULSANTS
Vörulýsing:
Active ingredient group (AIG) number: 0125929003; AHFS:
Leyfisstaða:
CANCELLED PRE MARKET
Leyfisdagur:
2023-07-24
Vara einkenni
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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..............................................................
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