ACC 200mg Hot Drink 200mg powder for oral solution

国家: 亚美尼亚

语言: 英文

来源: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

有效成分:

acetylcysteine

可用日期:

Salutas Pharma GmbH

ATC代码:

R05CB01

INN（国际名称）:

acetylcysteine

剂量:

200mg

药物剂型:

powder for oral solution

每包单位数:

(20) sachets 3g

处方类型:

OTC

授权状态:

Registered

授权日期:

2018-06-21

产品特点

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