Pilfud spray cutaneous,solution

Država: Armenija

Jezik: angleščina

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivna sestavina:

minoxidil

Dostopno od:

Bosnalijek d.d.

Koda artikla:

D11AX01

INN (mednarodno ime):

minoxidil

Odmerek:

50mg/ml

Farmacevtska oblika:

spray cutaneous,solution

Enote v paketu:

60ml plastic vial

Tip zastaranja:

OTC

Status dovoljenje:

Registered

Datum dovoljenje:

2018-06-27

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
PILFUD
®
5%
cutaneous spray, solution
minoxidil
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of the solution contains 50,00 mg of minoxidil.
For excipients see_ section_ 6.1.
3.
PHARMACEUTICAL FORM
Cutaneous spray, solution.
Clear, pale yellow to orange coloured solution.
4.
CLINICAL PARTICULARS
4.1.THERAPEUTIC INDICATIONS
Pilfud is indicated for the treatment of androgenic alopecia in men
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 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
two months. Once a clinical improvement is achieved, one should
continue to apply Pilfud as usual, in
1.3.1 Summary of Product Characteristics
SmPCD002925/1
PILFUD 5% _ cutaneous spray, solution
Page: 1 / 12
Page: 71 / 146
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 65 years has not been established.
ME