APO-MONTELUKAST TABLET (CHEWABLE)

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

MONTELUKAST (MONTELUKAST SODIUM)

Dostupno od:

APOTEX INC

ATC koda:

R03DC03

INN (International ime):

MONTELUKAST

Doziranje:

5MG

Farmaceutski oblik:

TABLET (CHEWABLE)

Sastav:

MONTELUKAST (MONTELUKAST SODIUM) 5MG

Administracija rute:

ORAL

Jedinice u paketu:

15G/50G

Tip recepta:

Prescription

Područje terapije:

LEUKOTRIENE MODIFIERS

Proizvod sažetak:

Active ingredient group (AIG) number: 0133823001; AHFS:

Status autorizacije:

APPROVED

Datum autorizacije:

2019-04-26

Svojstava lijeka

Page 1 of 31
PRODUCT MONOGRAPH
PR
APO-MONTELUKAST
montelukast (as montelukast sodium)
4 mg and 5 mg chewable tablets
Leukotriene Receptor Antagonist
APOTEX INC.
DATE OF REVISION:
150 Signet Drive
November 2, 2021
Toronto, Ontario
M9L 1T9
SUBMISSION CONTROL NO.: 256160
Page 2 of 31
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......................................................................................12
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..............................................................................................................19
TOX