Ambroton syrup

Țară: Armenia

Limbă: engleză

Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredient activ:

ambroxol (ambroxol hydrochloride)

Disponibil de la:

Arpimed LLC

Codul ATC:

R05CB06

INN (nume internaţional):

ambroxol (ambroxol hydrochloride)

Dozare:

15mg/5ml

Forma farmaceutică:

syrup

Unități în pachet:

100ml glass bottle and measuring spoon

Tip de prescriptie medicala:

OTC

Statutul autorizaţiei:

Registered

Data de autorizare:

2016-06-08

Caracteristicilor produsului

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AMBROTON
SYRUP 15MG/5ML
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ambroton
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of syrup contains 3 mg ambroxol hydrochloride.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Syrup
Ambroton syrup is a clear or almost clear, colourless or almost
colourless, slightly viscous syrup.
4. CLINICAL PARTICULARS
_4.1 THERAPEUTIC INDICATION _
Acute and chronic respiratory diseases with the release of viscous
mucus: acute and chronic bronchitis,
pneumonia,
chronic
obstructive
pulmonary
disease,
bronchial
asthma
with
obstruction
of
sputum
discharge, multiple bronchiectasis.
_4.2 POSOLOGY AND METHOD OF ADMINISTRATION _
For oral use, regardless of the meals.
Children 6-12 years: 5ml (15mg ambroxol) 2-3 times/day. The maximum
dose - 45mg/day. After 2-3 days,
if the child is getting better, the drug can be taken 2 times/day.
Children 2-5 years: 2.5ml (7.5mg ambroxol) 3 times/day; the maximum
dose - 22.5mg/day. After 2-3 days,
if the child is getting better, the drug can be taken 2 times/day.
Children under 2 years of age: the drug is contraindicated in children
under 2 years of age.
_Patients with impaired renal and hepatic function:_ Patients with
impaired renal function or severe liver
dysfunction should take the medication only as directed by a
physician. Meanwhile the dose should be
either reduced or the time between doses should be increased.
_Missed dose:_ If the patient has forgotten to take medication or took
an insufficient dose, he/she needs to
continue taking the drug according to the dose regimen. If symptoms do
not improve or worsen after 5 days
of treatment, consult your doctor.
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_4.3 CONTRAINDICATION _
Hypersensitivity to ambroxol or other components of the drug.
First trimester of pregnancy.
A rare hereditary intolerance to any component of Ambroton (see
"Special precautions").
Children under 2 years of age.
_Use with caution _in_ _II and III trimester of pregnancy, lactation,
renal and/or hepatic insufficiency