APO-MONTELUKAST TABLET (CHEWABLE)
Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Charakteristika produktu
(SPC)
02-11-2021
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Aktivní složka:
MONTELUKAST (MONTELUKAST SODIUM)
Dostupné s:
APOTEX INC
ATC kód:
R03DC03
INN (Mezinárodní Name):
MONTELUKAST
Dávkování:
5MG
Léková forma:
TABLET (CHEWABLE)
Složení:
MONTELUKAST (MONTELUKAST SODIUM) 5MG
Podání:
ORAL
Jednotky v balení:
15G/50G
Druh předpisu:
Prescription
Terapeutické oblasti:
LEUKOTRIENE MODIFIERS
Přehled produktů:
Active ingredient group (AIG) number: 0133823001; AHFS:
Stav Autorizace:
APPROVED
Datum autorizace:
2019-04-26
Charakteristika produktu
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
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