KERATOSPOR

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

BIFONAZOLE; UREA

Dostupné z:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

ATC kód:

D01AC10

Forma lieku:

OINTMENT

Zloženie:

UREA 40 %; BIFONAZOLE 1 %

Spôsob podávania:

NAIL

Typ predpisu:

Required

Výrobca:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

Terapeutické skupiny:

BIFONAZOLE

Terapeutické oblasti:

BIFONAZOLE

Terapeutické indikácie:

For nail stripping and antifungal treatment of fungal infections of the finger nails and toe nails.

Dátum Autorizácia:

2022-05-31

Príbalový leták

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only.
AGISPOR ONYCHO-SET/KERATOSPOR
OINTMENT
EACH TUBE CONTAINS:
BIFONAZOLE 1%
UREA 40%
Inactive ingredients and allergens 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.
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 THIS MEDICINE INTENDED FOR?
Antifungal preparation for the treatment of fungal infections of the
fingernails and toenails and for nail stripping.
THERAPEUTIC GROUP
Bifonazole - imidazole antifungal.
Urea – an organic compound for treatment of dry skin.
2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE:
if you are sensitive (allergic) to the active ingredients or to any of
the other ingredients in the medicine.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE BEFORE TREATMENT WITH AGISPOR ONYCHO-SET/KERATOSPOR, INFORM
THE DOCTOR IF
• you have a known sensitivity to antifungals from the imidazole
group such as: econazole, clotrimazole, miconazole.
• you are sensitive to any food or medicine. IF YOU ARE TAKING, OR HAVE RECENTLY TAKEN, OTHER MEDICINES,
INCLUDING NON-PRESCRIPTION MEDICINES AND NUTRITIONAL SUPPLEMENTS,
INFORM THE DOCTOR OR PHARMACIST. It is particularly important to
inform
the doctor or pharmacist if you are taking warfarin. PREGNANCY AND BREASTFEEDING
If you are pregnant, consult a doctor. Use of this preparation is not
recommended in the first trimester of pregnancy.
Do not use if you are breastfeeding. USE IN CHILDREN AND INFANTS
Use in children and toddlers must be done under medical
supervision. IMPORTANT INFORMATION REGARDING SOME OF THE INGREDIENTS OF THE
MEDICINE
The medicine contains wool wax (=wool fat).
Avoid contact

Súhrn charakteristických

PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
AGISPOR
Cream, solution, gel, shampoo
AGISPOR ONYCHOSET
Nail ointment
KERATOSPOR
Nail ointment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1.
PREPARATIONS
QUALITATIVE COMPOSITION IN TERMS OF THE ACTIVE INGREDIENT(S) (INN):
Cream, cutaneous solution, gel, shampoo: Bifonazole
Ointment: Bifonazole in combination with urea
QUANTITATIVE COMPOSITION IN TERMS OF THE ACTIVE INGREDIENT(S) PER
DOSAGE FORM
_ _
_ _
1g cream contains 10 mg bifonazole
1 ml cutaneous solution contains 10 mg bifonazole
1 g gel contains 10 mg bifonazole
1 g shampoo contains 10 mg bifonazole
1 g nail ointment contains 10 mg bifonazole and 400 mg urea
_ _
3. PHARMACEUTICAL FORM
3.1.
PREPARATIONS
Pharmaceutical formulation in accordance with standardized
terminology:
Cream
Cutaneous solution
Gel
Shampoo
Ointment
4. CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
AGISPOR CREAM, SOLUTION AND GEL:
Broad spectrum antimycotic agent.
AGISPOR SHAMPOO:
Pityriorisis versicolor and sebarrrhoeic dermatitis of the scalp
caused by pityrosporum.
AGISPOR ONYCHOSET AND KERATOSPOR NAIL OINTMENT:
For nail stripping and antifungal treatment of fungal infections of
the finger nails and toe
nails.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
AGISPOR CREAM, SOLUTION AND GEL:
Posology:
To achieve a lasting cure, treatment with AGISPOR cream, solution and
gel must be
carried out reliably and over an adequate period. The usual periods of
treatment are
summarized in the table below:
INDICATION
DURATION OF TREATMENT
Foot mycoses (Tinea pedis, tinea pedum
interdigitalis)
3 weeks
Mycoses of the trunk, hands and skin
folds (Tinea corporis, tinea manuum,
tinea inguinalis)
2-3 weeks
Pityriasis versicolor
2 weeks
Erythrasma
2 weeks
Superficial candidiasis of the skin
2-4 weeks
Method of administration:
Cream, solution or gel is used once a day, preferably in the evening,
before retiring. It
should be applied thinly to the affected skin area and rubbed in.
Cream: A small amount of cream is generally sufficient to treat an
ar