AGISTEN BABY

Země: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktivní složka:

CLOTRIMAZOLE

Dostupné s:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

ATC kód:

D01AC

Léková forma:

PASTE

Složení:

CLOTRIMAZOLE 1 %

Podání:

DERMAL

Druh předpisu:

Not required

Výrobce:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

Terapeutické skupiny:

IMIDAZOLE AND TRIAZOLE DERIVATIVES

Terapeutické indikace:

For treatment of fungal nappy rash in children, that lasts over 72 hours.

Datum autorizace:

2022-02-28

Informace pro uživatele

PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed without
a doctor’s prescription
AGISTEN BABY
PASTE
CLOTRIMAZOLE 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.
Use the 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 7 days.
1. WHAT IS THE MEDICINE INTENDED FOR?
For the treatment of fungal diaper rash in children,
that lasts for more than 72 hours.
THERAPEUTIC GROUP: An antifungal preparation from
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 or any of the additional
ingredients contained in the medicine.
∙ for treatment of infections of the scalp or nails.
SPECIAL WARNINGS REGARDING USE OF THIS MEDICINE
Before first use of this preparation, it is advisable
to consult a doctor in order to avoid unnecessary
use. This preparation should only be used in cases of
irritation that have not passed after 72 hours.
Do not use this medicine frequently or for a prolonged
period without consulting a doctor.
Do not use on open wounds.
Avoid contact between the preparation and 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 BABY, TELL THE DOCTOR
IF:
∙ You are not sure if the patient suffers from a fungal
infection.
∙ The patient is sensitive to any food or medicine.
IF YOU OR YOUR CHILD ARE TAKING, OR HAVE RECENTLY
TAKEN, OTHER MEDICINES, INCLUDING NON-PRESCRIPTION
MEDICINES AND NUTRITIONA

Charakteristika produktu

PRESCRIBING INFORMATION
1
NAME OF THE MEDICINAL PRODUCT
Agisten Baby
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clotrimazole 1.0% w/w.
Excipients with known effect: Wool fat.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
A white to cream colored paste for topical use.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For treatment of fungal nappy rash in children, that lasts over 72
hours.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
A thin layer should be applied to the affected sites and gently rubbed
in 2 times daily.
A strip of paste 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.
Do not use to treat nail or scalp infections.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Avoid contact with the eyes.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Laboratory tests have suggested that, when Clotrimazole paste 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 reproductive toxicity at
high oral
doses (see section 5.3). At the low systemic exposures of clotrimazole
following
topical treatment, harmful effects with respect to reproductive
toxicity are not
predicted.Clotrimazole can be used during pregnancy, but only under
the supervision
of a physician.
Lactation:
Available pharmacodynamic/toxicological data in animals have shown
excretion of
clotrimazole/metabolites in milk after intravenous administ