PEPCID AC TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

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Last ned Preparatomtale (SPC)
24-05-2019

Aktiv ingrediens:

FAMOTIDINE

Tilgjengelig fra:

MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC

ATC-kode:

A02BA03

INN (International Name):

FAMOTIDINE

Dosering :

10MG

Legemiddelform:

TABLET

Sammensetning:

FAMOTIDINE 10MG

Administreringsrute:

ORAL

Enheter i pakken:

18/30/60

Resept typen:

OTC

Terapeutisk område:

HISTAMINE H2-ANTAGONISTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0118722003; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2011-12-02

Preparatomtale

                                _PEPCID AC_
_®_
_Page 1 of 18_
PRODUCT MONOGRAPH
PEPCID AC
®
famotidine tablets
FILM COATED TABLETS 10 MG
Mfr.
Std.
HISTAMINE H
2
RECEPTOR ANTAGONIST
McNeil Consumer Healthcare,
division of Johnson & Johnson Inc.
88 McNabb Street
Markham, Ontario
L3R 5L2
Date of Preparation:
February 14, 1996
Date of Revision:
May 24, 2019
Submission Control No: 225990
_PEPCID AC_
_®_
_Page 2 of 18_
_PEPCID AC_
_®_
_Page 3 of 18_
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
....................................................................................................4
DRUG INTERACTIONS
....................................................................................................5
DOSAGE AND ADMINISTRATION
................................................................................5
OVERDOSAGE
...................................................................................................................6
ACTION AND CLINICAL PHARMACOLOGY
...............................................................6
STORAGE AND STABILITY
............................................................................................8
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................8
PART II: SCIENTIFIC
INFORMATION................................................................................12
PHARMACEUTICAL INFORMATION
..........................................................................12
CLINICAL TRIALS
.......................................................
                                
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