RANITIDINE TABLET
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
18-09-2019
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:
RANITIDINE (RANITIDINE HYDROCHLORIDE)
Fáanlegur frá:
PRO DOC LIMITEE
ATC númer:
A02BA02
INN (Alþjóðlegt nafn):
RANITIDINE
Skammtar:
300MG
Lyfjaform:
TABLET
Samsetning:
RANITIDINE (RANITIDINE HYDROCHLORIDE) 300MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
100/30
Gerð lyfseðils:
Prescription
Lækningarsvæði:
HISTAMINE H2-ANTAGONISTS
Vörulýsing:
Active ingredient group (AIG) number: 0115150001; AHFS:
Leyfisstaða:
CANCELLED POST MARKET
Leyfisdagur:
2023-07-10
Vara einkenni
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RANITIDINE_ _
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PRODUCT MONOGRAPH
PR RANITIDINE
Ranitidine Tablets, USP
150 mg & 300 mg ranitidine (as ranitidine hydrochloride)
Histamine H
2
-receptor antagonist
PRO DOC LTÉE
2925, boul. Industriel
Laval, Quebec
H7L 3W9
Date of Revision:
September 18, 2019
Submission Control No: 229390
RANITIDINE_ _
_Page 2 of 28_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
....................................................................................................7
DOSAGE AND ADMINISTRATION
................................................................................8
OVERDOSAGE
................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................10
STORAGE AND STABILITY
..........................................................................................12
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................12
PART II: SCIENTIFIC INFORMATION
................................................................................13
PHARMACEUTICAL INFORMATION
..........................................................................13
CLINICAL TRIALS
..........................................................................................................14
DETAILED PHARMACOLOGY
................
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