Reparil-gel N gel for external use

Nchi: Armenia

Lugha: Kiingereza

Chanzo: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Shusha Tabia za bidhaa (SPC)
30-12-2020

Viambatanisho vya kazi:

escin, diethylamine salicylate

Inapatikana kutoka:

Madaus GmbH

ATC kanuni:

առկա չէ (M02AC)

INN (Jina la Kimataifa):

escin, diethylamine salicylate

Kipimo:

0.01g/g+ 0.05g/g

Dawa fomu:

gel for external use

Vitengo katika mfuko:

40g aluminium tube

Dawa ya aina:

OTC

Idhini hali ya:

Registered

Idhini ya tarehe:

2020-12-30

Tabia za bidhaa

                                I:\RUZ\ALLOPA
TH\Reparii
Akut\OOSS IER\TEI L-1
B\Texte Verlanqerunq
2008\spc-en-aea-november -2008-14te-novelle.
rtf
Seite 1 von 5
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
REPARIL® - GEL N
Active substances: Escin 1 % and 2-Hydroxybenzoic acid, diethylazan
salt (Diethylamine
salicylate) 5 %
2.
QUALITATIVE
AND QUANTITATIVE COMPOSITION
100 g gel contains:
Active substances:
Escin
1 g
2-Hydroxybenzoic acid, diethylazan (Diethylamine salicylate)
5g
Other ingredients:
For the complete listing of other ingredients see section 6.1.
3.
PHARMACEUTICAL
FORM
Gel
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For topical, supportive symptomatic treatment of minor complaints
following acute
blunt injuries (e.g., contusions, sprains)
If complaints persist for more than 2 days or deteriorate, a doctor
should be consulted.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Apply Reparil®-gel N 3 times daily. Depending on the size of the
painful area to be
treated, an amount of the size of a cherry or walnut, equivalent to
2.5 g to 6.0 g of gel
(0.13 mg to 0.3 mg diethylamine salicylate) is required. The maximum
total daily dose is
20 g of gel, equivalent to 1 g of diethylamine salicylate.
METHOD OF ADMINISTRATION
For topical use only! Do not ingest!
Spread a thin layer of Reparil®-gel N onto the affected areas of the
skin and rub the
medicine in gently.
Before applying a dressing Reparil®-gel N should dry for several
minutes on the skin.
The use of an occlusive bandage is not recommended.
1:\RUZ\ALLOPATH\ReparilAkut\DOSSIER\TEIL-1 8\Texte Verlangerung
2008\spc-en-aea-november-2008-14te-novelle.rtf
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DURATION OF USE:
The treating doctor will determine the length of treatment. As a rule,
treatment over 1-2
days is sufficient. There is no evidence for the therapeutic benefit
of treatment with
Reparil®-gel N beyond this period.
SPECIFIC PATIENT
GROUPS:
ELDERLY PATIENTS:
No special dose adjustment is required. Because of the potential side
effect profile, elderly
patients should be mon
                                
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