DAKTACORT CREAM

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

HYDROCORTISONE; MICONAZOLE NITRATE

متاح من:

J-C HEALTH CARE LTD

ATC رمز:

D07CA01

الشكل الصيدلاني:

CREAM

تركيب:

HYDROCORTISONE 10 MG/G; MICONAZOLE NITRATE 20 MG/G

طريقة التعاطي:

TOPICAL

نوع الوصفة الطبية :

Required

المصنعة من قبل:

JANSSEN PHARMACEUTICA N.V.,BELGIUM

المجموعة العلاجية:

HYDROCORTISONE AND ANTIBIOTICS

المجال العلاجي:

HYDROCORTISONE AND ANTIBIOTICS

الخصائص العلاجية:

Infections of the skin caused by dermatophytes or candida species in which inflammatory symptoms are prominent.

تاريخ الترخيص:

2020-01-31

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
)PREPARATIONS( – 1986
The medicine is dispensed with
a doctor’s prescription only
NAME OF THE MEDICINE, ITS FORM AND STRENGTH
DAKTACORT
® CREAM
ACTIVE INGREDIENTS AND CONCENTRATIONS
Miconazole nitrate 20 mg/g (2% w/w);
hydrocortisone 10 mg/g (1% w/w)
Inactive and allergenic ingredients in the preparation –
see in section 2 “Important information about some of
the ingredients of the medicine” and section 6 “Further
Information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING
THE MEDICINE. This leaflet contains concise information
about the medicine. If you have further questions, refer
to the doctor or pharmacist.
This medicine has been prescribed to treat you. Do not
pass it on to others. It may harm them, even if it seems
to you that their medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Daktacort Cream is a cream for the treatment of skin
infections caused by fungi, including yeasts. Daktacort
Cream is particularly intended for the treatment of
infections accompanied by pronounced redness and
itching.
THERAPEUTIC GROUP:
Miconazole nitrate – an antifungal from the imidazole
group, which works by destroying both the fungi that
cause infection and some of the associated bacteria.
Hydrocortisone – a low-potency anti-inflammatory
steroid for external use, which reduces inflammation,
swelling, redness and itching of the skin.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
• you are sensitive )allergic( to the active ingredients
or any of the additional ingredients contained in the
medicine, or to other similar antifungal medicines.
For a list of the additional ingredients, see section 6
“Further Information”.
• you have other skin problems, such as cold sores,
herpes, chickenpox or shingles. Use this preparation
only for the skin problem you have shown to the
doctor.
Do not use this preparation if any of these conditions
apply to you. If you are uncertain, talk to the doctor or
ph

خصائص المنتج

1
Daktacort cream_SPC_03_2021_sub
1. NAME OF THE MEDICINAL PRODUCT
DAKTACORT CREAM
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Miconazole nitrate 2% w/w and hydrocortisone 1% w/w.
Excipients with known effect
Daktacort ceam contains 2 mg/g benzoic acid (E210)
15 g: This medicine contains 30 mg benzoic acid in each tube of 15 g
cream which
is equivalent to 2 mg/g cream.
Daktacort ceam contains 0.052 mg/g butylated hydroxyanisole (E320).
For full list of
excipients, see section 6.1.
3. PHARMACEUTICAL FORM
White, homogeneous cream.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Infections
of
the
skin
caused
by
dermatophytes
or
candida
species
in
which
inflammatory symptoms are prominent.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For topical administration.
The properties of Daktacort ceam indicate it particularly for the
initial stages of
treatment
.
Because
of
its
corticosteroid
content
avoid
long-term
treatment
with
Daktacort ceam.
Daktacort ceam
should be applied topically to the lesion once to twice daily. It
should
be rubbed in gently until it has been completely penetrated into the
skin. The
treatment with Daktacort ceam
(or subsequently with miconazole nitrate 20 mg/g
topical
cream)
should
be
continued
without
interruption
until
the
lesion
has
completely disappeared (usually after 2 to 5 weeks).
Elderly
Natural thinning of the skin occurs in the elderly, hence
corticosteroids should be
used sparingly and for short periods of time.
Paediatrics
In infants and children, caution is advised when Daktacort ceam is
applied to
extensive surface areas or under occlusive dressings including baby
napkins (diapers).
2
Daktacort cream_SPC_03_2021_sub
In infants, long term continuous topical corticosteroid therapy should
be avoided (see
_Section 4.4_
).
4.3 CONTRAINDICATIONS
True hypersensitivity to miconazole/miconazole nitrate, other
imidazole derivatives,
hydrocortisone or to any of the excipients listed in section 6.1.
Tubercular or viral
infections of the skin or those caused by Gram-negative bacteria.
4.4
SPECIA