Mycofine 5% wv Nail Lacquer

Ülke: Malezya

Dil: İngilizce

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

Aktif bileşen:

Amorolfine Hydrochloride

Mevcut itibaren:

PAHANG PHARMACY SDN. BHD.

INN (International Adı):

Amorolfine Hydrochloride

Paketteki üniteler:

2.5ml ml

Tarafından üretildi:

Chanelle Medical Unlimited Company

Bilgilendirme broşürü

CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)
MYCOFINE 5% W/V NAIL LACQUER
AMOROLFINE HYDROCHLORIDE 5% W/V NAIL LACQUER
WHAT IS IN THIS LEAFLET
1.
What
_Mycofine _
is used for
2.
How
_Mycofine _
works
_3._
_ _
Before you use
_Mycofine _
_4._
_ _
How to use
_Mycofine _
5.
While you are using it
6.
Side effects
_7._
_ _
Storage and Disposal of
_Mycofine _
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT _MYCOFINE _IS USED FOR
_Mycofine _
is
used
to
treat
fungal
infections of the nails.
_Mycofine _
contains
active
ingredient
amorolfine (as the hydrochloride) which
belongs to a group of medicines known
as antifungals. It kills a wide variety of
fungi that can cause nail infections.
HOW _MYCOFINE _WORKS
Amorolfine from nail lacquer penetrates
into and diffuses through the nail plate
and
is
thus
able
to
eradicate
poorly
accessible fungi in the nail bed. Systemic
absorption of the active ingredient is very
low with this type of application.
BEFORE YOU USE _MYCOFINE _
_ - When you must not use it _
Do not use
_Mycofine _
if you are:
•
Allergic (hypersensitive) to amorolfine
or
any
of
the
other
ingredients
of
_Mycofine_
.
Please
check
by
reading
the
list
of
ingredients in section 8. If you an- swer
yes, you must inform your doctor before
starting
treatment.
Please
seek
immediate
medical
attention
if
you
experience
symptoms
of
an
allergic
reaction. Signs or symptoms of a severe
allergic reaction may include a rash, with
or without itching, swelling of the face,
eyelids or lips and difficulty in breathing.
•
Pregnant,
planning
to
become
pregnant, or are breast-feeding.
•
Do not use in children under 12 years
of age. The safety and effectiveness of
amorolfine in children have not been
established.
Pregnancy and breast-feeding:
You should not use
_Mycofine _
and tell
your doctor if you are pregnant, planning
to
become
pregnant
or
are
breast-
feeding. Your doctor will then decide
whether you should use
_Mycofine_
.
Ask your doctor or pharmacist for advic

Ürün özellikleri

Chanelle
KPW Print Management
Ballinasloe, Co. Galway, Ireland
139587
Mycofine 5%w/v Nail Lacquer Leaflet
200 x 686 mm
4 April 2023 2:16 pm
LB11043
1
Customer
Colour
Fonts
Helvetica Neuen Lt Std: Minimum font size used 9.2pt
_Please proof read this PDF carefully as responsibility for ANY
errors/omissions will lie with yourselves upon sign off._
Description
Pharmacode
Size
Date
Item Code
Version No.
KPW Job No.
Black
Keyline
Mycofine 5% w/v Nail Lacquer
Amorolfine hydrochloride 5% w/v Nail Lacquer
1.
Name of the Medicinal Product
Mycofine 5% w/v Nail Lacquer
2.
Qualitative and Quantitative Composition
1 ml contains 55.74 mg amorolfine hydrochloride (equivalent to 50 mg
amorolfine).
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Medicated Nail Lacquer.
Clear, colourless to pale yellow solution
4. Clinical Particulars
4.1
Therapeutic Indications
Indicated in onychomycosis caused by dermatophytes, yeasts and moulds.
4.2
Posology and Method of Administration
Posology
The nail lacquer should be applied to the affected finger or toe nails
once weekly.
Twice weekly application may prove beneficial in some cases.
The patient should apply the nail lacquer as follows:
1.
Before the application of Mycofine 5% w/v Nail Lacquer, it is
essential that the affected areas of nail (particularly the nail
surfaces) should
be filed down as thoroughly as possible using the nail file supplied.
The surface of the nail should then be cleansed and degreased using an
alcohol cleaning pad. Before repeat application of Mycofine 5% w/v
Nail Lacquer the affected nails should be filed down again as
required,
following cleansing with a cleaning pad to remove any remaining
lacquer.
_Caution:_ Nail files used for affected nails must not be used for
healthy nails.
2.
With one of the reusable applicators supplied, apply the nail lacquer
to the entire surface of the affected nail. Allow the nail lacquer to
dry
for 3-5 minutes. After use, clean the applicator with the same
cleaning pad used before for nail cleaning. Keep the bot