Aetos Minoxidil Topical Solution 5%wv

Nchi: Malesia

Lugha: Kiingereza

Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Nunua Sasa

Shusha Taarifa za kipeperushi (PIL)
05-09-2023
Shusha Tabia za bidhaa (SPC)
05-09-2023

Viambatanisho vya kazi:

MINOXIDIL

Inapatikana kutoka:

AETOS PHARMA SDN BHD

INN (Jina la Kimataifa):

MINOXIDIL

Vitengo katika mfuko:

100 ml

Viwandani na:

Farmalabor - Produtos Farmaceuticos, S.A.

Taarifa za kipeperushi

                                _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
AETOS MINOXIDIL TOPICAL SOLUTION 5%W/V
Minoxidil (5%w/v)
WHAT IS IN THIS LEAFLET
1.
What
Aetos
Minoxidil
Topical
Solution 5%w/v is used for
2.
How
Aetos
Minoxidil
Topical
Solution 5%w/v works
3.
Before
you
use
Aetos
Minoxidil
Topical Solution 5%w/v
4.
How to use Aetos Minoxidil Topical
Solution 5%w/v
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Aetos
Minoxidil Topical Solution 5%w/v
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT
AETOS
MINOXIDIL
TOPICAL
SOLUTION 5%W/V IS USED FOR
Aetos Minoxidil Topical Solution 5%w/v
contains a medicine called Minoxidil.
Aetos Minoxidil is used to stimulate hair
growth and is used in the treatment of
hair loss (alopecia androgenetica)
HOW AETOS MINOXIDIL TOPICAL SOLUTION
5%W/V WORKS
The
mechanism
by
which
minoxidil
stimulates
hair
growth
is
not
fully
understood, but minoxidil can reverse the
hair
loss
process
of
androgenetic
alopecia by increasing the diameter of
the hair shaft, stimulating anagen growth,
prolonging
the
anagen
phase
and
stimulating
anagen
recovery
from
the
telegon phase.
As
a
peripheral
vasodilator,
minoxidil
enhances
microcirculation
to
hair
follicles.
The
Vascular
Endothelial
Growth Factor (VEGF) is stimulated by
minoxidil
and
VEGF
is
presumably
responsible
for
the
increased
capillary
fenestration,
indicative
of
a
high
metabolic activity that observed during
the anagen phase.
BEFORE
YOU
USE
AETOS
MINOXIDIL
TOPICAL SOLUTION 5%W/V
-
_When you must not use it _
_ _
Do not take this medicinal product if you
have the following conditions:

Do not use Aetos Minoxidil if you
are
known
hypersensitivity
to
any
ingredients in this medicine.

Do
not
apply
Aetos
Minoxidil
to
inflamed scalp skin or areas affected
by
psoriasis,
severe
sunburn,
or
severe excoriations, because of the
risk of increased absorption

Do not use this product if you are
under the age of 18 or over the age
of 65.

Do not use this product if you have
ever had a bad r
                                
                                Soma hati kamili
                                
                            

Tabia za bidhaa

                                TO BE SUPPLIED ONLY ON THE PRESCRIPTION OF A REGISTERED MEDICAL
PRACTITIONER
COMPOSITION
Each ml contains 50mg of minoxidil (5%w/v) Contains ethanol (51%w/v)
PRODUCT DESCRIPTION
Aetos Minoxidil Topical Solution 5%w/v is a cutaneous solution
available as a
clear, colourless to yellowish
homogeneous
solution, free from particles in
suspension.
PHARMACODYNAMICS
The mechanism by which cutaneous minoxidil and/or its metabolite
stimulates hair
growth is not yet clear. However, it is believed that minoxidil acts
at a hair follicle
level, by increasing the blood flow in the scalp due to local
vasodilation, stimulat-
ing
anagen
growth,
prolonging
the
anagen
phase
and
stimulating
anagen
recovery from telegon phase. As a peripheral vasodilator, minoxidil
enhances
microcirculation to hair follicles. The Vascular Endothelial Growth
Factor (VEGF)
is stimulated by minoxidil and VEGF is responsible for the increased
capillary
fenestration, which indicating of high metabolic activity during the
anagen phase.
PHARMACOKINETICS
Minoxidil percutaneous absorption is approximately 0.3% to 4.5% of the
total dose
applied, after cutaneous application of hydroalcoholic solutions at 2%
containing
propylene glycol. Minoxidil is not bound to plasma protein. It is
distributed into
breast milk. Minoxidil is extensively metabolised by the liver. It
requires sulfation to
become active, but the major metabolites is a glucuronide conjugate.
Minoxidil is
excreted predominantly in the urine mainly in the form of metabolites.
Minoxidil
and its metabolites are dialysable although the pharmacological effect
is not
reversed.
INDICATION
Aetos Minoxidil Topical Solution 5%w/v is exclusively indicated for
the treatment of
alopecia androgenetica in males and females.
Aetos Minoxidil Topical Solution 5%w/v stimulates hair growth and
stabilizes hair
loss in patients with alopecia androgenetic.
DOSAGE AND ADMINISTRATION
Use Aetos Minoxidil Topical Solution 5%w/v only as directed. Do not
apply Aetos
Minoxidil Topical Solution 5%w/v to any other area of the body.
                                
                                Soma hati kamili
                                
                            

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