Oflomil Nail Lacquer 5% wv

Country: মাল্যাশিয়া

ভাষা: ইংরেজি

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

সক্রিয় উপাদান:

Amorolfine Hydrochloride

থেকে পাওয়া:

Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.

INN (International Name):

Amorolfine Hydrochloride

প্যাকেজ ইউনিট:

2.5 ml

Manufactured by:

GLENMARK PHARMACEUTICALS LTD

তথ্য লিফলেট

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
1
OFLOMIL NAIL LACQUER 5% W/V
AMOROLFINE HYDROCHLORIDE 5% W/V
WHAT IS IN THIS LEAFLET
1.
What
_Oflomil_
is used for
2.
How
_Oflomil_
works
3.
Before you use
_Oflomil_
4.
How to use
_Oflomil_
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
_Oflomil_
8.
Product Description
9.
Manufacturer
10.
Product Registration
Holder
11.
Date of Revision
12.
Serial Number
WHAT _OFLOMIL_ IS USED FOR
_Oflomil_
is used to treat fungal infections of
the nails.
HOW _OFLOMIL_ WORKS
_Oflomil _
is a topical antimycotic, containing
active ingredient amorolfine (as amorolfine
hydrochloride). It belongs to a new chemical
class, and its fungicidal action is based on an
alteration
of
the
fungal
cell
membrane
targeted primarily on sterol biosynthesis.
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.
Microbiology
Amorolfine is a broad spectrum antimycotic.
It is highly active (MIC < 2mcg/ml)
_in vitro_
against

_yeasts: Candida, Cryptococcus, _
_Malassezia _

_dermatophytes: Trichophyton, _
_Microsporum, Epidermophyton _

_moulds: Hendersonula, Alternaria, _
_Scopulariopsis _

_dematiacea: Cladosporium, Fonsecaea, _
_Wangiella _

_dimorphic _
_fungi: _
_Coccidioides, _
_Histoplasma, Sporothrix _
_ _
With the exception of
_Actinomyces_
, bacteria
are
not
sensitive
to
amorolfine.
_Propionibacterium _
_acnes_
is
only
slightly
sensitive.
BEFORE YOU USE _OFLOMIL_
-
_When you must not use it _
_ _
DO NOT USE _OFLOMIL_ IF YOU ARE:

Allergic (hypersensitive) to amorolfine or
any of the other ingredients of
_Oflomil. _
Please
check
list
of
ingredients
_ _
stated
under
_ _PRODUCT DESCRIPTION
section. If you
answer yes, you must inform your doctor
before
starting
treatment.
Please
seek
immediate
medical
attention
if
you
experience
symptoms
of
an
allergic
reaction. Signs or sympto

পণ্য বৈশিষ্ট্য

SAME SIZE ARTWORK
LEAFLET SIZE : 176 mm x 186 mm
22 mm
24 mm
Manufactured by:
B/2, Mahalaxmi Chambers,
22, Bhulabhai Desai Road,
Mumbai - 400 026, (India).
At: Plot No. E-37, 39, D-Road,
MIDC, Satpur, Nashik - 422 007,
Maharashtra State, India
® Registered Trade Mark
PE00000 MY
PANTONE
BLACK PROCESS C
SUPERSEDES
ARTWORK CODE
PANTONE SHADE
ICONGRAPHICS CODE:
PHARMACODE:
SPACE FOR
PHARMACODE
SPACE FOR
PHARMACODE
SPACE FOR
PHARMACODE
SPACE FOR
PHARMACODE
PRODUCT REGISTRATION HOLDER
Glenmark Pharmaceuticals (Malaysia)
Sdn Bhd (660397-W) D-31-02,
Menara Suezcap 1,No. 2,
Jalan Kerinchi, 59200 Kuala Lumpur,
Malaysia.
COMPOSITION
Amorolfine Hydrochloride Ph.Eur
equivalent to Amorolfine
5% w/v
Absolute Alcohol
63.5% v/v
Base
q.s..
PHARMACEUTICAL FORM
Nail Lacquer
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Onychomycoses caused by dermatophytes, yeasts and moulds
POSOLOGY AND METHOD OF ADMINISTRATION
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 first application of Amorolfine 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 a
cleaning pad (as supplied). Cosmetic nail lacquer may be applied at
least 10 min after amorolfine 5% nail lacquer application.
Before repeat application of Amorolfine Nail Lacquer, any remaining
nail lacquer, and cosmetic nail lacquer if any, should be removed
carefully, then the affected nails should be filed down again as
required, and at any rate be cleansed with an alcohol soaked swab 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 nails and allow it to dry. After
use,
c