DIMETANE EXPECTORANT DC SYRUP
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
28-01-2021
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Werkstoffen:
PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE; GUAIFENESIN; HYDROCODONE BITARTRATE
Beschikbaar vanaf:
FOUNDATION CONSUMER BRANDS, LLC
ATC-code:
R05FA02
INN (Algemene Internationale Benaming):
OPIUM DERIVATIVES AND EXPECTORANTS
Dosering:
5MG; 2MG; 100MG; 1.8MG
farmaceutische vorm:
SYRUP
Samenstelling:
PHENYLEPHRINE HYDROCHLORIDE 5MG; BROMPHENIRAMINE MALEATE 2MG; GUAIFENESIN 100MG; HYDROCODONE BITARTRATE 1.8MG
Toedieningsweg:
ORAL
Eenheden in pakket:
100
Prescription-type:
Narcotic (CDSA I)
Therapeutisch gebied:
ANTITUSSIVES
Product samenvatting:
Active ingredient group (AIG) number: 0444285001; AHFS:
Autorisatie-status:
CANCELLED POST MARKET
Autorisatie datum:
2021-12-31
Productkenmerken
Page 1 of 28
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
DIMETANE
®
EXPECTORANT DC
Brompheniramine Maleate, Phenylephrine Hydrochloride, Guaifenesin and
Hydrocodone
Bitartrate Syrup
2 mg/ 5 mg/ 100 mg/1.8 mg: per 5 mL of syrup
Antihistamine/ Decongestant/ Expectorant/ Antitussive
Foundation Consumer Brands LLC.
106 Isabella Street, Suite 602
Pittsburgh, PA
15212, USA
Date of Revision:
January 28, 2021
Distributed by:
Accuristix
100 Vaughan Valley Blvd.,
Vaughan, Ontario, Canada
L4H 3C5,
Submission Control No:
247426
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
..................................................................................................11
DRUG INTERACTIONS
..................................................................................................11
DRUG INTERACTIONS
..................................................................................................11
DOSAGE AND ADMINISTRATION
...........................................................................12
OVERDOSAGE
...............................................................................................................13
ACTION AND CLINICAL PHARMACOLOGY
............................................................14
STORAGE AND
STABILITY........................................................................................14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................15
PART II: SCIENTIFIC INFORMATION
............................
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