RAN-MONTELUKAST TABLET (CHEWABLE)

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
21-03-2016

Viambatanisho vya kazi:

MONTELUKAST (MONTELUKAST SODIUM)

Inapatikana kutoka:

RANBAXY PHARMACEUTICALS CANADA INC.

ATC kanuni:

R03DC03

INN (Jina la Kimataifa):

MONTELUKAST

Kipimo:

5MG

Dawa fomu:

TABLET (CHEWABLE)

Tungo:

MONTELUKAST (MONTELUKAST SODIUM) 5MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

30

Dawa ya aina:

Prescription

Eneo la matibabu:

LEUKOTRIENE MODIFIERS

Bidhaa muhtasari:

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

Idhini hali ya:

CANCELLED POST MARKET

Idhini ya tarehe:

2022-07-28

Tabia za bidhaa

                                1
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PRODUCT MONOGRAPH
PR
RAN™-MONTELUKAST
Montelukast Chewable Tablets
montelukast (as montelukast sodium)
4mg and 5mg
Leukotriene Receptor Antagonist
Ranbaxy Pharmaceuticals Canada Inc.
DATE OF REVISION:
126 East Drive
March 21, 2016
Brampton, ON
L6T 1C1
Control #: 192448
RAN Trademark owned by Sun Pharmaceutical Industries Ltd.
2
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
............................................................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................................... 17
PART II: SCIENTIFIC INFORMATION
...........................................................................................
18
CLINICAL TRIALS
....................
                                
                                Soma hati kamili
                                
                            

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