RANITIDINE TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

RANITIDINE (RANITIDINE HYDROCHLORIDE)

Διαθέσιμο από:

PRO DOC LIMITEE

Φαρμακολογική κατηγορία (ATC):

A02BA02

INN (Διεθνής Όνομα):

RANITIDINE

Δοσολογία:

300MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

RANITIDINE (RANITIDINE HYDROCHLORIDE) 300MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100/30

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

HISTAMINE H2-ANTAGONISTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0115150001; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2023-07-10

Αρχείο Π.Χ.Π.

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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_ _
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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
................