DYNAMIZOLE CREAM 2% WW

Kraj: Malezja

Język: angielski

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

Składnik aktywny:

MICONAZOLE NITRATE

Dostępny od:

DYNAPHARM (M) SDN BHD

INN (International Nazwa):

MICONAZOLE NITRATE

Sztuk w opakowaniu:

15 gm

Wyprodukowano przez:

DYNAPHARM (M) SDN BHD

Ulotka dla pacjenta

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
DYNAMIZOLE CREAM 2% W/W
Miconazole Nitrate 20mg/g
1
WHAT IS IN THIS LEAFLET
1.
What Dynamizole Cream 2% w/w is
used for
2.
How Dynamizole Cream 2% w/w
works
3.
Before you use Dynamizole Cream 2%
w/w
4.
How to use Dynamizole Cream 2% w/w
5.
While you are using Dynamizole Cream
2% w/w
6.
Side effects
7.
Storage and Disposable of Dynamizole
Cream 2% w/w
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of revision
11.
Serial Number
WHAT DYNAMIZOLE CREAM 2% W/W IS USED
FOR
Dynamizole Cream 2% w/w is used for
treating
infection
of
the
skiin
by
fungi
including yeast .
Dynamizole Cream 2% w/w is used for:

Infection on scalp, the beard, the trunk,
the feet and hand in the groin;

Diapers rash in babies.
HOW DYNAMIZOLE CREAM 2% W/W WORKS
Miconazole Nitrate - an antifungal which
works by destroying both the fungus that
causes
the
infection
and
some
of
the
associated
bacteria
which
may
also
be
present.
BEFORE YOU USE DYNAMIZOLE CREAM 2%
W/W
_-When you must not use it _
Do not use Dynamizole Cream 2% w/w if
you know you are hypersensitive to it or to
other of it excipients.
_Pregnancy and lactation _
_Pregnancy _
Dynamizole Cream 2% w/w is minimally
absorbed into the skin/nail. If you pregnant
or planning to become pregnant, ask your
doctor if you should use Dynamizole Cream
2% w/w.
_Lactation _
It is not known whether the active ingredient
is excreted in human breast milk. If you are
nursing, ask your doctor if you should use
Dynamizole Cream 2% w/w.
_-Before you start to use it _
Oral
anticoagulants
(blood
thinning
medications):
Ask
your
doctor
or
pharmacist before use if you are taking an
oral
blood
thinning
medication,
such
as
warfarin.
_-Taking other medicines _
Other
medications: The effects and side
effects
of
some
other
prescription
medications, when taken with Miconazole,
can
be
increased.
Ask
your
doctor
or
pharmacist before use if you are taking any
other medications.
HOW TO USE DYNAMIZOLE CREAM 2% W/W
For successful treatment,

Charakterystyka produktu

DYNAMIZOLE CREAM 2% W/W
MAL
DESCRIPTION:
CREAM
Color
:
White
Fragrance
:
Natural
CONTENT:
Miconazole Nitrate ............................... 2% w/w
Preservative: Chlorocresol ................. 0.1% w/w
PHARMACODYNAMICS:
Miconazole Nitrate is an imidazole antifungal agent and may act by
interfering with the permeability of the fungal
cell membrane. It possesses a wide antifungal spectrum and has some
antibacterial activity.
PHARMACOKINETICS:
Absorption: There is little absorption through skin or mucous
membranes when Miconazole Nitrate is applied
topically.
Distribution: Absorbed Miconazole is bound to plasma proteins (88.2%)
and red blood cells (10.6%).
Metabolism and Excretion: The small amount of Miconazole that is
absorbed is eliminated predominantly in faeces
as both unchanged drug and metabolites.
INDICATIONS:
Skin infections due to dermatophytes or yeasts, and other fungi such
as: _Tinea capitis, corporis, manuum, barbae, _
_cruris, pedis _(athlete's foot).
Since Dynamizole Cream 2% w/w has an antibacterial effect on
gram-positive bacteria, it may be used in mycoses
secondarily infected with such bacteria (e.g. in napkin dermatitis).
ROUTE OF ADMINISTRATION
Topical
RECOMMENDED DOSE:
Dosage and Administration
Apply some cream to the lesions twice daily. The duration of therapy
varies from 2 to 6 weeks depending on the
localization and the severity of the lesion. Treatment should be
continued at least one week after disappearance of
all signs and symptoms.
Administration
For topical use. Rub the cream into the skin with your finger until it
fully penetrated the skin
CONTRAINDICATIONS:
Dynamizole Cream 2% w/w is contraindicated in individuals with a known
hypersensitivity to Miconazole /
Miconazole Nitrate, other imidazole derivatives or to any of the
excipients.
WARNING AND PRECAUTIONS:
Severe hypersensitivity reactions, including anaphylaxis and
angioedema, have been reported during treatment
with Dynamizole Cream 2% w/w and with other Miconazole topical
formulations. If a reaction suggesting
hypersensitivit