ACC 200 200mg powder for oral solution

Valsts: Armēnija

Valoda: angļu

Klimata pārmaiņas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktīvā sastāvdaļa:

acetylcysteine

Pieejams no:

Salutas Pharma GmbH

ATĶ kods:

R05CB01

SNN (starptautisko nepatentēto nosaukumu):

acetylcysteine

Deva:

200mg

Zāļu forma:

powder for oral solution

Vienības iepakojumā:

(20) sachets 3g

Receptes veids:

OTC

Autorizācija statuss:

Registered

Autorizācija datums:

2015-04-14

Produkta apraksts

ACC POS 100 & 200 KNGL: 721-7765, 721-5932
June, 2014
CDS acetylcysteine_oral_v03_05_2014
p. 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS/SPC
1. NAME OF THE MEDICINAL PRODUCT
ACC
®
granules for oral solution, 100 mg and 200 mg
Active substance: acetylcysteine
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet with granules contains 100 mg or 200 mg acetylcysteine.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Granules for oral solution
Appearance: white homogeneous granules without agglomerated particles,
with orange aroma.
4. CLINICAL PARTICULARS
_4.1 Therapeutic Indications_
Secretolytic therapy in case of acute and chronic bronchopulmonary
diseases accompanied by
impaired formation and transport of secretion such as acute and
chronic bronchitis,
obstructive bronchitis, laryngotracheitis, pneumonia, bronchiectasia,
bronchial asthma,
bronchiolitis, mucoviscidosis. Acute and chronic sinusitis, otitis
media.
_4.2 Posology and Method of Administration_
If not otherwise prescribed, the following daily dosages are
recommended:
-
_Adults and adolescents over the age of 14_:
_2 sachets of ACC 100 mg or 1 sachet of ACC 200 mg twice or three
times daily (_400-
600 mg of acetylcysteine per day_)_
-
_Children from 6 to 14 years of age_:
ACC 100 mg: 1 sachet three times daily or 2 sachets two times daily or
ACC 200 mg: ½ sachet three times daily or 1 sachet two times daily
(equivalent to 300-400 mg of acetylcysteine per day)
-
_Children from 2 to 6 years of age_:
1 sachet of ACC 100 mg or ½ sachet of ACC 200 mg two or three times
daily
(equivalent to 200-300 mg of acetylcysteine per day_)._
_Mucoviscidos_is
-
_Children over the age of 6 years_: 2 sachets of ACC 100 mg or 1
sachet of ACC 200 mg
3 times daily (equivalent to 600 mg of acetylcysteine per day_)_
_Children from 2 to 6 years of age_: 1 sachet of ACC 100 mg or ½
sachet of ACC 200
mg 4 times daily (equivalent to 400 mg of acetylcysteine per day_)_
ACC POS 100 & 200 KNGL: 721-7765, 721-5932
June, 2014
CDS acetylcysteine_oral_v03_05_2014