AGISTEN ALOEVERA CREAM

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

CLOTRIMAZOLE

متاح من:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

ATC رمز:

D01AC01

الشكل الصيدلاني:

CREAM

تركيب:

CLOTRIMAZOLE 1 %W/W

طريقة التعاطي:

DERMAL

نوع الوصفة الطبية :

Not required

المصنعة من قبل:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

المجموعة العلاجية:

CLOTRIMAZOLE

المجال العلاجي:

CLOTRIMAZOLE

الخصائص العلاجية:

For the treatment of fungal infections of the skin and mucosa caused by dermatophytes, yeasts, molds and other fungi such as Malassezia furfur, as well as skin infections caused by Corynebacterium minutissimum.Indicated also for Candida Vulvitis and Candida balanitis.

تاريخ الترخيص:

2014-05-31

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed without a doctor’s prescription
AGISTEN ALOEVERA
CREAM
CLOTRIMAZOLE 1%
Inactive and allergenic ingredients in the preparation – see
section 6.
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.
Use this medicine in the correct manner.
Consult the pharmacist if you need further information. Refer
to the doctor if symptoms of the illness worsen or if they do
not improve after 4 weeks.
1. WHAT IS THE MEDICINE INTENDED FOR?
For the treatment of skin infections caused by dermatophytes
or
Candida
strains.
Agisten Aloevera Cream is intended for the treatment of skin
fungi and jock itch. The preparation treats a variety of fungal
strains, which may appear in different parts of the body;
the feet and toes, armpits, groin, skin folds and other areas
of the skin.
THERAPEUTIC GROUP: An antifungal preparation of the imidazole
group.
2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE:
∙ if you or your child are sensitive )allergic( to the active
ingredient, cetostearyl alcohol or any of the additional
ingredients contained in the medicine.
∙ for treatment of infections of the scalp or nails.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
As with other creams, Agisten Aloevera Cream may lower the
effectiveness of contraceptives made of rubber, such as a
condom or diaphragm. Therefore, if the medicine is intended
for use on the genitals, use an alternative contraceptive for
at least five days after using this medicine.
Do not use this medicine often or for a prolonged period
without consulting a doctor.
Avoid contact of the preparation with the eyes and mouth.
In case of contact with the eyes or mouth, wash thoroughly
with water and refer to a doctor. BEFORE TREATMENT WITH AGISTEN ALOEVERA CREAM, TELL THE
DOCTOR IF:
∙ You are not sure if you )or your ba

خصائص المنتج

PRESCRIBING INFORMATION
1
NAME OF THE MEDICINAL PRODUCT
Agisten Aloevera Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clotrimazole 1.0% w/w.
Excipient with known effect: cetostearyl alcohol
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
A white cream for topical use.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Skin infections caused by dermatophytes or candida species.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
To ensure complete healing, treatment should be continued for about 2
weeks after the
disappearance of the subjective symptoms. The following are the usual
periods of treatment:
Dermatomycoses
3-4 weeks
Erythrasma
2-4 weeks
Pityriasis versicolor
1-3 weeks
Candida vulvitis and balanitis
1-2 weeks
A thin layer should be applied to the affected sites and gently rubbed
in 2 times daily. A
strip of cream ½ cm long is sufficient to treat an area about the
size of a hand.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1, including cetostearyl alcohol.
Do not use the cream to treat nail or scalp infections.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Agisten Aloevera cream contains cetostearyl alcohol, which may cause
local skin reactions (e.g. contact dermatitis). Avoid contact with the
eyes.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Laboratory tests have suggested that, when Clotrimazole cream is used
together, this
product may cause damage to latex contraceptives. Consequently the
effectiveness
of such contraceptives may be reduced. Patients should be advised to
use alternative
precautions for at least five days after using this product.
4.6
PREGNANCY AND LACTATION
Fertility:
No human studies of the effects of clotrimazole on fertility have been
performed; however,
animal studies have not demonstrated any effects of the drug on
fertility.
Pregnancy:
There is a limited amount of data from the use of clotrimazole in
pregnant women. Animal
studies with clotrimazole have shown repr