Permethrin cream

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

permethrin

Available from:

Arpimed LLC

ATC code:

P03AC04

INN (International Name):

permethrin

Dosage:

50mg/g

Pharmaceutical form:

cream

Units in package:

aluminum tube 50g

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2019-12-17

Summary of Product characteristics

SUMMARY PRODUCT CHARACTERISTIC (SPC)
PERMETHRIN
5 % CREAM
1.1 BRAND NAME – PERMETHRIN
1.2 INTERNATIONAL NON-PROPERTY NAME - PERMETHRIN
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
_active ingredient:_ permethrin – 50 mg;
_For a full list of excipients, see section 6.1 _
3. PHARMACEUTICAL FORM
White homogenous odorless cream.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Permethrin cream is indicated for the treatment of scabies in adults
and children >2 months of age,
and crab lice in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
TREATMENT OF SCABIES
Adults and adolescents over 12 years of age:
Apply up to 30 g of cream (corresponding to 60% tube of 50 g).
Paediatric population
_Children aged from 6 - 12 years:_
Apply up to 15 g of cream (corresponding to 30% tube of 50 g).
_Children aged from 2 months - 5 years:_
Up to 7.5 g of cream (corresponding to 15% tube of 50 g)..
The safety and efficacy of Permethrin cream in children under 2 months
of age have not been
established. No data are available.
TREATMENT OF CRAB LICE
Adults over 18 years of age:
Apply up to 30 g of cream (corresponding to 60% tube of 50 g).
METHOD OF ADMINISTRATION
For cutaneous use only. The medicinal product must not be swallowed.
Carefully apply a thin layer of cream to the skin (cutaneous use).
_For treatment of scabies:_
Adults should apply the cream uniformly to the whole body including
the neck, palms of the hands
and soles of the feet. The head and face can be spared unless scabies
efflorescences are present in
this region.
On application, the areas between the fingers and toes (also under the
finger- and toe-nails), the
wrists, elbows, armpits, external genitalia and the buttocks should be
especially carefully treated.
Paediatric population
Children should apply the cream uniformly to the whole body, including
the palms of the hands,
soles of the feet, neck, face, ears, and scalp. Parts of the skin
around the mouth (because the cream
could be licked off) and the eyes should be spared. Children should b