Eludril PRO solution for mouthwash

Ülke: Ermenistan

Dil: İngilizce

Kaynak: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktif bileşen:

chlorhexidine (chlorhexidine digluconate), chlorobutanol (chlorobutanol hemihydrate)

Mevcut itibaren:

Pierre Fabre Medicament Production

ATC kodu:

A01AB03

INN (International Adı):

chlorhexidine (chlorhexidine digluconate), chlorobutanol (chlorobutanol hemihydrate)

Doz:

1mg/ml+ 5mg/ml

Farmasötik formu:

solution for mouthwash

Paketteki üniteler:

plastic bottle 90ml and measuring cup

Reçete türü:

OTC

Yetkilendirme durumu:

Registered

Yetkilendirme tarihi:

2016-07-20

Ürün özellikleri

1
APPENDIX I
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
ELUDRILPRO, SOLUTION FOR MOUTHWASH
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine digluconate solution
................................................................
0.5 ml
Chlorobutanol hemihydrate
...........................................................................
0.5 g
For 100 ml of mouthwash solution
Alcohol content: 42.8% (V/V)
For excipients, see 6.1.
3. PHARMACEUTICAL FORM
Solution for mouthwash
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Local adjuvant treatment for infections of the mouth and
post-operative care in dentistry and
stomatology
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
FOR ADULTS AND CHILDREN OVER 6 YEARS OF AGE ONLY.
Mouthwash for topical use.
Do not swallow.
USUAL DOSE: 10 to 15 ml of solution twice daily (to be diluted in the
measuring cup by filling with
warm water up to the top line): use the mouthwash until all of the
contents of the measuring cup
have been used up.
If necessary, the dose may be increased to 3 times daily, bearing in
mind that the maximum dose
is 20 ml (to be diluted), 3 times daily.
Teeth must be brushed before each use and mouth must be rinsed
carefully with water before
using ELUDRILPRO, solution for mouthwash.
For the single-dose bottle, dilute the contents of the bottle in half
a glass of water and use the
mouth wash.
Treatment may last 2 weeks for gingival inflammation and
periodontitis. The treatment duration
may only be extended beyond 2 weeks on medical advice.
2
4.3 CONTRAINDICATIONS
This medicinal product MUST NEVER BE USED in the event of
hypersensitivity to chlorhexidine,
chlorobutanol or other ingredients in the solution.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Do not let the product come into contact with the eyes and nose. Do
not insert the product into the
ear canal.
If symptoms persist for more than 5 days and/or in the event of
concomitant fever, management
must be re-assessed.
Long-term use can lead to a risk of staining of the