AGISPOR SOLUTION

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

BIFONAZOLE

Verfügbar ab:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

ATC-Code:

D01AC10

Darreichungsform:

SOLUTION

Zusammensetzung:

BIFONAZOLE 1 %W/V / 100 ML

Verabreichungsweg:

DERMAL

Verschreibungstyp:

Not required

Hergestellt von:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

Therapiegruppe:

BIFONAZOLE

Therapiebereich:

BIFONAZOLE

Anwendungsgebiete:

Broad spectrum antimycotic agent.

Berechtigungsdatum:

2023-10-31

Gebrauchsinformation

PATIENT PACKAGE INSERT
IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed without
a doctor’s prescription
AGISPOR
CREAM, GEL,
SOLUTION
EACH AGISPOR TUBE OF CREAM OR GEL OR
BOTTLE OF SOLUTION CONTAINS:
BIFONAZOLE 1%
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.
Refer to the doctor if the symptoms
worsen or if they do not improve within
7 days.
1. WHAT IS THE MEDICINE INTENDED
FOR?
Broad spectrum antifungal medicine.
THERAPEUTIC
GROUP:
Imidazole
antifungal.
2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE:
• if you are sensitive )allergic( to the
active ingredient or to any of the
other ingredients in the medicine.
• for treatment of diaper rash. If your
baby has a diaper rash, refer to a
doctor for appropriate treatment.
• for treatment of inflammation of the
nails and scalp.
• f o r
t re a t m e n t
o f
v a g i n a l
inflammations.
SPECIAL WARNINGS REGARDING USE OF THE
MEDICINE BEFORE TREATMENT WITH AGISPOR, INFORM
THE DOCTOR IF
• you have previously had an allergic
reaction to any kind of antifungal
agent.
• AGISPOR
SOLUTION:
WARNING!
FLAMMABLE, KEEP AWAY FROM FIRE. DO
NOT LIGHT A CIGARETTE OR BE EXPOSED TO
AN OPEN FLAME UNTIL THE PRODUCT HAS
COMPLETELY DRIED. 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
Do not use the medicine if you are
pregnant or breastfeeding, except with
the doctor’s recommendation. USE IN CHILDREN AND INFANTS
Use in infants and toddlers must be done
under medical supervision. IMPORTANT INFORMATION REGARDING SOME
OF THE INGREDIENTS OF THE MEDICINE
The medicine contains cetyl

Fachinformation

PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
AGISPOR SOLUTION
AGISPOR GEL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
1 ml solution contains 10 mg bifonazole
1 g gel contains 10 mg bifonazole
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Solution
Gel
4. CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Broad spectrum antimycotic agent.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
AGISPOR SOLUTION AND GEL:
Posology:
To achieve a lasting cure, treatment with AGISPOR 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:
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.
Solution: A few drops (about 3 drops) is generally sufficient to treat
an area of about the size
of the palm of the hand.
Gel: A strip of gel (1/2 cm long) is generally sufficient to treat an
area of about the size of
the palm of the hand.
USE IN CHILDREN
No in-depth studies have been performed in children. From a survey of
the clinical data
reported there is no indication that harmful effects should be
anticipated in children.
However, in infants and toddlers, Agispor should only be used under
medical supervision.
4.3.
CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the
excipients listed in section 6.1
Agispor solution is not suitable for use in the ear canal.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients with a history of hypersensitivity reactions to other
imidazole antifungal agents (e.g.
econazole, clotrimazole, miconazole) should use bifonazole containing
products with cautio