DALMACOL SYRUP
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
12-06-2020
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Aktiva substanser:
HYDROCODONE BITARTRATE; ETAFEDRIN HYDROCHLORIDE; SODIUM CITRATE; ALCOHOL ANHYDROUS; DOXYLAMINE SUCCINATE
Tillgänglig från:
LABORATOIRE ATLAS INC
ATC-kod:
R05DA20
INN (International namn):
COMBINATIONS
Dos:
1.65MG; 16.65MG; 200MG; 0.25ML; 6MG
Läkemedelsform:
SYRUP
Sammansättning:
HYDROCODONE BITARTRATE 1.65MG; ETAFEDRIN HYDROCHLORIDE 16.65MG; SODIUM CITRATE 200MG; ALCOHOL ANHYDROUS 0.25ML; DOXYLAMINE SUCCINATE 6MG
Administreringssätt:
ORAL
Enheter i paketet:
500ML/2L
Receptbelagda typ:
Narcotic (CDSA I)
Terapiområde:
ANTITUSSIVES
Produktsammanfattning:
Active ingredient group (AIG) number: 0514272001; AHFS:
Bemyndigande status:
MARKETED
Tillstånd datum:
1983-12-31
Produktens egenskaper
DALMACOL
Page 1 of 25
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
DALMACOL
Hydrocodone Bitartrate, Etafedrine Hydrochloride, Doxylamine
Succinate,
Sodium Citrate and Alcohol Syrup
Hydrocodone bitartrate hemipentahydrate 0.33 mg/mL,
etafedrine hydrochloride 3.33 mg/mL,
doxylamine succinate 1.2 mg/mL,
sodium citrate dihydrate 40 mg/mL
and alcohol anhydrous 0.05 mL/mL
ANTITUSSIVE / ANTIHISTAMINIC / DECONGESTANT
LABORATOIRE ATLAS INC.
9600 Boul. Des Sciences
Montreal, Québec
Canada H1J 3B6
Date of Preparation:
June 12, 2020
Submission Control No: 239361
DALMACOL
Page 2 of 25
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
..............................................................................12
OVERDOSAGE
................................................................................................................13
STORAGE AND STABILITY
..........................................................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................13
PART II: SCIENTIFIC INFORMATION
...............................................................................15
PHARMACEUTICAL INFORMATION
..........................................................................15
PART
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