AURO-MONTELUKAST CHEWABLE TABLET TABLET (CHEWABLE)
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
10-11-2020
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Aktiva substanser:
MONTELUKAST (MONTELUKAST SODIUM)
Tillgänglig från:
AURO PHARMA INC
ATC-kod:
R03DC03
INN (International namn):
MONTELUKAST
Dos:
4MG
Läkemedelsform:
TABLET (CHEWABLE)
Sammansättning:
MONTELUKAST (MONTELUKAST SODIUM) 4MG
Administreringssätt:
ORAL
Enheter i paketet:
10/30
Receptbelagda typ:
Prescription
Terapiområde:
LEUKOTRIENE MODIFIERS
Produktsammanfattning:
Active ingredient group (AIG) number: 0133823003; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2014-03-25
Produktens egenskaper
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PRODUCT MONOGRAPH
PR
AURO-MONTELUKAST CHEWABLE TABLET
montelukast (as montelukast sodium)
4 mg and 5 mg chewable tablets
Leukotriene Receptor Antagonist
AURO PHARMA INC. Date of Revision:
3700 Steeles Avenue West, Suite # 402 November 10, 2020
Woodbridge, Ontario, L4L 8K8
CANADA
SUBMISSION CONTROL NO.: 244280
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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
...................................................................................................
7
DRUG INTERACTIONS
.................................................................................................
10
DOSAGE AND
ADMINISTRATION.............................................................................
11
OVERDOSAGE................................................................................................................
13
ACTION AND CLINICAL
PHARMACOLOGY............................................................
13
STORAGE AND
STABILITY.........................................................................................
17
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................. 17
PART II: SCIENTIFIC
INFORMATION..........................................................................
18
PHARMACEUTICAL INFORMATION
.........................................................................
18
CLINICAL TRIALS
.........................................................................................................
18
TOXICOLOGY.....................
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