COLD AND SINUS PLUS TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
06-10-2016
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Aktiv bestanddel:
CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Tilgængelig fra:
MARCAN PHARMACEUTICALS INC
ATC-kode:
M01AE51
INN (International Name):
IBUPROFEN, COMBINATIONS
Dosering:
2MG; 200MG; 30MG
Lægemiddelform:
TABLET
Sammensætning:
CHLORPHENIRAMINE MALEATE 2MG; IBUPROFEN 200MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30MG
Indgivelsesvej:
ORAL
Enheder i pakken:
10/20/24/40/72/100
Recept type:
OTC
Terapeutisk område:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Produkt oversigt:
Active ingredient group (AIG) number: 0349765001; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2016-09-27
Produktets egenskaber
1 | P a g e
PRODUCT MONOGRAPH
COLD AND SINUS PLUS
Ibuprofen 200 mg, Pseudoephedrine Hydrochloride 30 mg and
Chlorpheniramine
Maleate 2 mg
Tablets
Analgesic/Antipyretic/Nasal Decongestant/Antihistamine
Date of Preparation:
September 27, 2016
Marcan Pharmaceuticals Inc.
77 Auriga Drive, Unit # 4
Ottawa, Ontario
K2E 7Z7
Submission Control No.: 197591
2 | P a g e
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
...........................................................................................................................
11
DRUG INTERACTIONS
............................................................................................................................
20
DOSAGE AND ADMINISTRATION
........................................................................................................
24
OVERDOSAGE
..........................................................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
......................................................................................
27
STORAGE AND STABILITY
....................................................................................................................
33
SPECIAL HANDLING INSTRUCTIONS
.................................................................................................
33
DOSAGE FORMS, COMPOSITIO
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