Land: Israel
Sprog: engelsk
Kilde: Ministry of Health
CLOTRIMAZOLE
PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL
D01AC
PASTE
CLOTRIMAZOLE 1 %
DERMAL
Not required
PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL
IMIDAZOLE AND TRIAZOLE DERIVATIVES
For treatment of fungal nappy rash in children, that lasts over 72 hours.
2022-02-28
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 Læs hele dokumentet
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 Læs hele dokumentet