AURO-MONTELUKAST CHEWABLE TABLET TABLET (CHEWABLE)

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

MONTELUKAST (MONTELUKAST SODIUM)

Διαθέσιμο από:

AURO PHARMA INC

Φαρμακολογική κατηγορία (ATC):

R03DC03

INN (Διεθνής Όνομα):

MONTELUKAST

Δοσολογία:

4MG

Φαρμακοτεχνική μορφή:

TABLET (CHEWABLE)

Σύνθεση:

MONTELUKAST (MONTELUKAST SODIUM) 4MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

10/30

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

LEUKOTRIENE MODIFIERS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0133823003; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2014-03-25

Αρχείο Π.Χ.Π.

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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.....................