COVAN SYRUP
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
04-11-2019
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Active ingredient:
TRIPROLIDINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE; CODEINE PHOSPHATE
Available from:
PHARMASCIENCE INC
ATC code:
R05DA20
INN (International Name):
COMBINATIONS
Dosage:
2MG; 30MG; 10MG
Pharmaceutical form:
SYRUP
Composition:
TRIPROLIDINE HYDROCHLORIDE 2MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30MG; CODEINE PHOSPHATE 10MG
Administration route:
ORAL
Units in package:
500 ML
Prescription type:
Narcotic (CDSA I)
Therapeutic area:
ANTITUSSIVES
Product summary:
Active ingredient group (AIG) number: 0304415002; AHFS:
Authorization status:
MARKETED
Authorization date:
2000-12-11
Summary of Product characteristics
_Prescribing Information- COVAN _
_Page 1 of 34 _
PRESCRIBING INFORMATION
N
COVAN
SYRUP
(Triprolidine HCl – Pseudoephedrine HCl – Codeine phosphate)
ANTIHISTAMINE – ANTITUSSIVE DECONGESTANT
Pharmascience Inc.
611 Royalmount Ave., Suite #100
Montréal, Quebec
H4P 2T4
www.pharmascience.com
Date of Revision: November 4, 2019
Submission Control # 226627
_Prescribing Information- COVAN _
_Page 2 of 34 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................. 3
SUMMARY PRODUCT INFORMATION
................................................................ 3
INDICATIONS AND CLINICAL USE
......................................................................
3
CONTRAINDICATIONS
...........................................................................................
3
WARNINGS AND
PRECAUTIONS..........................................................................
5
ADVERSE REACTIONS
.........................................................................................
13
DRUG INTERACTIONS
..........................................................................................
14
OVERDOSAGE
........................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
.................................................... 21
STORAGE AND
STABILITY..................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................... 24
PART II: SCIENTIFIC INFORMATION
................................................................... 25
TOXICOLOGY
.........................................................................................................
25
PATIENT MEDICATION INFORMATION
.............................................................. 26
_Prescribing Information- COVAN _
_Page 3 of 34 _
PRESCRIBING INFORMATION
N
COVAN
SYRUP
(Triprolidine HCl – Pseudoephedrine HCl – Codeine Phosphate)
PART I: HEALTH PROFESSIONAL INFO
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