ACC 200mg Hot Drink 200mg powder for oral solution

Pays: Arménie

Langue: anglais

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingrédients actifs:

acetylcysteine

Disponible depuis:

Salutas Pharma GmbH

Code ATC:

R05CB01

DCI (Dénomination commune internationale):

acetylcysteine

Dosage:

200mg

forme pharmaceutique:

powder for oral solution

Unités en paquet:

(20) sachets 3g

Type d'ordonnance:

OTC

Statut de autorisation:

Registered

Date de l'autorisation:

2018-06-21

Résumé des caractéristiques du produit

a Novartis Company
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
ACC® 200 mg Hot drink
POWDER FOR ORAL SOLUTION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: acetylcysteine
1 sachet (3 g of powder) contains 200 mg acetylcysteine.
For a full list of excipients, see section 6.1 List of excipients
3.
PHARMACEUTICAL FORM
Powder for oral solution.
_Description: _White, homogenous powder with lemon and honey aroma._ _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Secretolytic therapy in case all bronchopulmonary diseases accompanied
by impaired
formation and transport of secretion such as acute and chronic
bronchitis, obstructive
bronchitis, bronchiolitis, bronchiectasia, pneumonia, laryngitis,
tracheitis, bronchial asthma,
mucoviscidosis, sinusitises, otitis media.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
If not otherwise prescribed, the following dosage is recommended for
ACC 200 mg:
_ _
-
Adults and adolescents over the age of 14:
1 sachet twice or three times daily (400-600 mg of acetylcysteine per
day)
-
Children from 6 to 14 years of age:
1 sachet two times daily (400 mg of acetylcysteine per day)
-
Children from 2 to 6 years of age:
½ sachet two or three times daily (200-300 mg of acetylcysteine per
day).
Mucoviscidosis
-
Children over the age of 6 years: 1 sachet 3 times daily (600 mg of
acetylcysteine per
day)
Children from 2 to 6 years of age: ½ sachet 4 times daily (400 mg of
acetylcysteine per
day)
Method of administration
2
KNGL: 721-7769
To be taken orally as a hot drink.
Contents of a sachet are dissolved in a glass of hot water while
stirring. Drink as hot as
possible after meals.
The mucolytic effect of ACC is supported by fluid supply.
The duration of treatment
The duration of treatment depends on the type and severity of the
disease.
In case of acute short-term cold-related diseases the therapy lasts
5-7 days.
In case of chronic bronchitis and mucoviscidosis, longer-term
treatment should be performed.
Maximum duration of treatment is 3-6 months.
4.3
CON