DIMETANE EXPECTORANT C SYRUP
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
28-01-2021
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Aktiv ingrediens:
PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE; CODEINE PHOSPHATE; GUAIFENESIN
Tilgjengelig fra:
FOUNDATION CONSUMER BRANDS, LLC
ATC-kode:
R05FA02
INN (International Name):
OPIUM DERIVATIVES AND EXPECTORANTS
Dosering :
1MG; 0.4MG; 2MG; 20MG
Legemiddelform:
SYRUP
Sammensetning:
PHENYLEPHRINE HYDROCHLORIDE 1MG; BROMPHENIRAMINE MALEATE 0.4MG; CODEINE PHOSPHATE 2MG; GUAIFENESIN 20MG
Administreringsrute:
ORAL
Enheter i pakken:
100ML/1000ML
Resept typen:
Narcotic (CDSA I)
Terapeutisk område:
ANTITUSSIVES
Produkt oppsummering:
Active ingredient group (AIG) number: 0444284001; AHFS:
Autorisasjon status:
CANCELLED POST MARKET
Autorisasjon dato:
2021-12-31
Preparatomtale
Page 1 of 29
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
DIMETANE
®
EXPECTORANT C
Brompheniramine Maleate, Phenylephrine Hydrochloride, Guaifenesin and
Codeine Phosphate
Syrup
0.4 mg / 1 mg / 20 mg / 2 mg: per mL of syrup
Antihistamine/Decongestant/Expectorant/Antitussive
Foundation Consumer Brands LLC
Pittsburgh, PA 15212, USA
Date of Revision:
January 28, 2021
Distributed by: Accuristix., Vaughan, ON L4H 3C5.
Submission Control No:
247367
Page 2 of 29
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
..................................................................................................11
DRUG INTERACTIONS
..................................................................................................11
DOSAGE AND ADMINISTRATION
...........................................................................13
OVERDOSAGE
...............................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
............................................................15
STORAGE AND
STABILITY........................................................................................15
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................15
PART II: SCIENTIFIC INFORMATION
...............................................................................17
PHARMACEUTICAL INFORMATION
..........................................................................17
PART III: CONSUMER MEDICATION INFORMATIO
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