Pilfud spray cutaneous, solution

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

minoxidil

Available from:

Bosnalijek d.d.

ATC code:

D11AX01

INN (International Name):

minoxidil

Dosage:

20mg/ml

Pharmaceutical form:

spray cutaneous, solution

Units in package:

60ml plastic vial

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2018-06-27

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
PILFUD
®
2%
cutaneous spray, solution
minoxidil
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of the solution contains 20,00 mg of minoxidil.
For excipients see_ section_ 6.1.
3.
PHARMACEUTICAL FORM
Cutaneous spray, solution.
Clear colourless to slightly yellow or slightly orange solution.
4.
CLINICAL PARTICULARS
4.1.THERAPEUTIC INDICATIONS
Pilfud is indicated for the treatment of androgenic alopecia in men
and women aged between 18 and 65.
The onset and degree of hair growth may vary among users. Although in
general younger patients, those
who have been balding for a shorter period of time, or who have a
smaller area of baldness on the head
surface better respond to the therapy with Pilfud, individual
responses cannot be predicted.
4.2.POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY (MEN AND WOMEN AGED 18-65)
Hair and scalp must be thoroughly dry prior to application of Pilfud.
A dose of 1 ml of Pilfud should be applied twice daily on the affected
area of the scalp.
The total daily dosage should not exceed 2 ml. If fingertips are used
to facilitate drug application, hands
should be washed afterwards.
In order to achieve the expected therapeutic effect, the solution
should be applied twice daily for at least
four months. Once a clinical improvement is achieved, one should
continue to apply Pilfud as usual, in
1.3.1 Summary of Product Characteristics
SmPCD002924/1
PILFUD 2 % cutaneous spray, solution
Page: 1 / 13
Page: 71 / 147
MODULE 1
order
to
maintain
the
hair
growth
process.
There
are
reports
indicating
that
3-4
months
after
discontinuation of Pilfud the balding process continues.
The treatment should be discontinued if there is no improvement after
one year.
SPECIAL POPULATIONS
There are no specific recommendations for use in patients with renal
or hepatic impairment.
PAEDIATRIC AND ELDERLY POPULATIONS
Not recommended. The safety and effectiveness of Pilfud in children
and adolescents below the age of 18
years or adults over the age of