Singulair tablets chewable

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

montelukast (montelukast sodium)

Доступна с:

Merck Sharp & Dohme B.V.

код АТС:

R03DC03 օրիգինալ դեղի հաջորդ դեղաչափ

ИНН (Международная Имя):

montelukast (montelukast sodium)

дозировка:

5mg (14/1x14/) in blister

Фармацевтическая форма:

tablets chewable

Штук в упаковке:

5mg (14/1x14/) in blister

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2021-03-10

Характеристики продукта

11
1.
NAME OF THE MEDICINAL PRODUCT
Singulair 5 mg chewable tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One chewable tablet contains montelukast sodium, which is equivalent
to 5 mg montelukast.
Excipients with known effect: This medicine contains 1.5 mg aspartame
(E 951) per tablet.
This medicine contains less than 1mmol (23mg) sodium per tablet, that
is to say essentially ‘sodium-
free’.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablet.
Pink, round, biconvex, diameter 9.5 mm with SINGULAIR engraved on one
side and MSD 275 on the
other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Singulair is indicated in the treatment of asthma as add-on therapy in
those patients with mild to
moderate persistent asthma who are inadequately controlled on inhaled
corticosteroids and in whom
“as-needed” short acting
β
-agonists provide inadequate clinical control of asthma.
Singulair may also be an alternative treatment option to low-dose
inhaled corticosteroids for 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).
Singulair is also indicated in the prophylaxis of asthma in which the
predominant component is
exercise-induced bronchoconstriction.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose for paediatric patients 6-14 years of age is one
5 mg chewable tablet daily to
be taken in the evening. If taken in connection with food, Singulair
should be taken 1 hour before or 2
hours after food. No dosage adjustment within this age group is
necessary.
General recommendations
The therapeutic effect of Singulair on parameters of asthma control
occurs within one day. Patients
should be advised to continue taking Singulair even if their asthma is
under control, as well as during
periods of worsening asthma.
No dosage adjustment is necessary for patients with renal
insu