Denk-Air Junior 4mg tablets chewable

Negara: Armenia

Bahasa: Inggris

Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Bahan aktif:

montelukast (montelukast sodium)

Tersedia dari:

Denk Pharma GmbH & Co. KG

Kode ATC:

R03DC03

INN (Nama Internasional):

montelukast (montelukast sodium)

Dosis:

4mg

Bentuk farmasi:

tablets chewable

Unit dalam paket:

(28/2x14/) in blister

Jenis Resep:

Prescription

Status otorisasi:

Registered

Tanggal Otorisasi:

2022-11-03

Selebaran informasi

_Denk-Air Junior 4 mg_
For children 2 to 5 years of age
Chewable tablet – oral use
Leukotriene receptor antagonist
Active substance: montelukast
Package leaflet: Information for the patient
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD STARTS
TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT IN-
FORMATION FOR YOU.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor
or pharmacist.
– This medicine has been prescribed for your child
only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as your
child´s.
– If your child gets any side effects, talk to your doctor
or pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet
1.
WHAT DENK-AIR JUNIOR 4 MG IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOUR
CHILD TAKES DENK-AIR
JUNIOR 4 MG
3.
HOW TO TAKE DENK-AIR JUNIOR 4 MG
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE DENK-AIR JUNIOR 4 MG
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
What Denk-Air Junior 4 mg is and what it
is used for
What Denk-Air Junior 4 mg is
Denk-Air Junior 4 mg is a medicine that blocks the binding
of certain inflammatory mediators (leukotrienes).
How Denk-Air Junior 4 mg works
Leukotrienes cause narrowing and swelling of the airways in
the lungs. By blocking the leukotrienes, Denk-Air Junior 4 mg
alleviates the symptoms of asthma, and helps to control
asthma.
When Denk-Air
Junior 4 mg should be used
The doctor has prescribed Denk-Air Junior 4 mg for your
child so as to prevent symptoms of asthma occurring during
the day and night.
•
Denk-Air
Junior 4 mg is used in children 2 to 5 years of
age whose asthma symptoms could not be adequately
controlled by previous medication and who require an
additional medical treatment.
•
Denk-Air Junior 4 mg can also be used in children 2 to 5
years of age instead of inhalations containing cortisone
(inhaled corticosteroids), under the following circum-
stances:
–
if there ha

Karakteristik produk

*ALL STATEMENTS MADE UNDER "DENK-AIR" APPLY - WHERE NOT OTHERWISE
APPARENT FROM THE CONTEXT -
TO DENK-AIR 10 MG, DENK-AIR JUNIOR 4 MG AND DENK-AIR JUNIOR 5 MG.
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCTS
Denk-Air Junior 4 mg
Denk-Air Junior 5 mg
Denk-Air 10 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: montelukast
_Denk-Air Junior 4 mg: _
Each chewable tablet contains 4 mg of montelukast (as montelukast
sodium).
Excipients with known effect: aspartame and sodium.
_Denk-Air Junior 5 mg: _
Each chewable tablet contains 5 mg of montelukast (as montelukast
sodium).
Excipients with known effect: aspartame and sodium.
_Denk-Air 10 mg: _
Each film-coated tablet contains 10 mg of montelukast (as montelukast
sodium).
Excipients with known effect: aspartame, sodium and sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
_Denk-Air Junior 4 mg: _
Chewable tablet.
Pink, flat, round, chewable tablets with beveled edges, with embossing
“4” on one side and plain on
the other.
_Denk-Air Junior 5 mg: _
Chewable tablet.
Pink, flat, round, chewable tablets with beveled edges.
_Denk-Air 10 mg: _
Film-coated tablet.
Beige, round, biconvex film-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DENK-AIR*
is indicated in the treatment of asthma as add-on therapy in patients
2 years of age and
over with mild to moderate persistent asthma who are inadequately
controlled on inhaled
corticosteroids and in whom “as-needed” short acting
β-symphatomimetics provide inadequate
clinical control of asthma.
2
Denk-Air may also be an alternative treatment option to low-dose
inhaled corticosteroids for 2 to 14
year old patients with mild persistent asthma who do not have a recent
history of serious asthma
attacks that required oral corticosteroid use, and who have
demonstrated that they are not capable of
using inhaled corticosteroids (see section 4.2).
In patients 15 years of age and over for whom Denk-Air° is indicated
in asthma, Denk-Air 10 mg fi