Benzyl benzoate emulsion topical

Nazione: Armenia

Lingua: inglese

Fonte: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Principio attivo:

benzyl benzoate

Commercializzato da:

Arpimed LLC

Codice ATC:

P03AX01

INN (Nome Internazionale):

benzyl benzoate

Dosaggio:

250mg/ml

Forma farmaceutica:

emulsion topical

Confezione:

120ml glass bottle

Tipo di ricetta:

OTC

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2018-09-24

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
BENZYL BENZOATE
25% EMULSION FOR TOPICAL USE
1.1 NAME OF THE MEDICAL PRODUCT – BENZYL BENZOATE
1.2 INTERNATIONAL NON-PROPERTY NAME – BENZYL BENZOATE
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of the emulsion contains benzyl benzoate 250 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Emulsion for topical use.
A white emulsion with specific odor.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This emulsion is used for the treatment of scabies and pediculosis (ie
hair or body lice).
SCABIES is a persistent itchy skin eruption caused by cutaneous
infestation with mites. The itch is
worse after bathing and at night. Scabies affects all races and social
classes world wide.
PEDICULOSIS is a relatively common problem in school children in
various parts of the world.
Females of all ages are more frequently infected than males. There
does not appear to be any direct
correlation between hair length and infestation rates.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
SCABIES: After total bathing Benzyl benzoate emulsion should be
applied to the whole body
except the head and face. A second application may be repeated within
5 days or alternatively it
may be applied on three occasions at 12 hourly intervals. Thorough
bathing with a complete
change of clothing and bedding should follow. All contacting clothes
and bedding should be
washed and/or cleaned. Repeat the following day and if necessary
within 5 days.
PEDICULOSIS: The affected region should be coated with Benzyl benzoate
emulsion followed by a
wash 24 hours later. Thorough bathing with a complete change of
clothing and bedding should
follow. All contacting clothes and bedding should be washed and/or
cleaned. This may be
repeated two or three times in severe cases.
For use in children the emulsion should be diluted with an equal
volume of water. For infants the
proportion of emulsion to water should be 1:3.
• In case of missing dose, it should apply as soon as patient
remembers it.
4.3 OVERDOSE