COLD AND SINUS PLUS TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

Διαθέσιμο από:

MARCAN PHARMACEUTICALS INC

Φαρμακολογική κατηγορία (ATC):

M01AE51

INN (Διεθνής Όνομα):

IBUPROFEN, COMBINATIONS

Δοσολογία:

2MG; 200MG; 30MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

CHLORPHENIRAMINE MALEATE 2MG; IBUPROFEN 200MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

10/20/24/40/72/100

Τρόπος διάθεσης:

OTC

Θεραπευτική περιοχή:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0349765001; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2016-09-27

Αρχείο Π.Χ.Π.

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
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3
INDICATIONS AND CLINICAL USE
........................................................................................................
3
CONTRAINDICATIONS
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3
WARNINGS AND PRECAUTIONS
...........................................................................................................
5
ADVERSE REACTIONS
...........................................................................................................................
11
DRUG INTERACTIONS
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20
DOSAGE AND ADMINISTRATION
........................................................................................................
24
OVERDOSAGE
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24
ACTION AND CLINICAL PHARMACOLOGY
......................................................................................
27
STORAGE AND STABILITY
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33
SPECIAL HANDLING INSTRUCTIONS
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33
DOSAGE FORMS, COMPOSITIO