Land: Israël
Taal: Engels
Bron: Ministry of Health
MICONAZOLE
J-C HEALTH CARE LTD
A01AB09
GEL
MICONAZOLE 20 MG/G
LOCAL ORAL
Not required
JANSSEN PHARMACEUTICA N.V.,BELGIUM
MICONAZOLE
MICONAZOLE
Oral mycosis (thrush) and fungal infections of the upper gastrointestinal tract. Daktarin oral gel can be used for the prevention of oral thrush in patient receiving long-term treatment with antibiotics, steroids, cytotoxic and radiation therapy.
2017-06-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed without a doctor’s prescription PRODUCT NAME AND ITS FORM DAKTARIN® ORAL GEL Active ingredient and its concentration: Miconazole 20 mg/g Inactive ingredients and allergens in the product - see 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. The medicine is not intended for infants below the age of 6 months or for infants whose swallowing reflex is not sufficiently developed, due to the risk of choking. Use it properly. Consult a pharmacist if you need further information. Refer to the doctor if the signs of the disease (symptoms) worsen or do not improve. 1. WHAT IS THIS MEDICINE INTENDED FOR? For the treatment and prevention of oral mycosis and fungal infections of the upper gastrointestinal tract (throat, esophagus, stomach, intestines). THERAPEUTIC GROUP: Antifungal, of the imidazole derivatives. 2. BEFORE USING THE MEDICINE DO NOT USE THIS MEDICINE IF: - you are sensitive (allergic) to miconazole, to similar antifungals or to any of the additional ingredients contained in the medicine. For the list of additional ingredients, see section 6 “Further Information”. - you are suffering from any liver disease. - in infants below the age of 6 months or in infants whose swallowing reflex is not sufficiently developed, due to the risk of choking. - you are taking any of the following medicines: - terfenadine, astemizole and mizolastine (medicines for hay fever or allergy). - cisapride (a medicine used to treat certain digestive problems). - cholesterol-lowering medicines, such as simvastatin and lovastatin. - midazolam (taken by mouth) and triazolam (medicines used to treat anxiety and sleep disorders). - pimozide and sertindole (medicines used to treat psychotic disorders). - quinidine and dofetilide (medic Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT DAKTARIN ORAL GEL 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of Daktarin Oral Gel contains 20 mg of miconazole. Excipients with known effect: Alcohol 7.85 mg per g, orange flavour (containing: citral, citronellol, d-limonene, geraniol, linalool) and cocoa flavour (containing: 0.00000000138 mg benzyl benzoate and 0.0000000023 mg of benzyl alcohol in each gram). For full list of excipients, see 6.1. 3 PHARMACEUTICAL FORM Oral gel. White gel with orange taste. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral mycosis (thrush) and fungal infections of the upper gastrointestinal tract. Daktarin Oral Gel can be used for the prevention of oral thrush in patients receiving long-term treatment with antibiotics, steroids, cytotoxic and radiation therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. 1 measuring spoon (provided) is equivalent to 124 mg miconazole per 5 mL gel. _Oropharyngeal candidosis _ Infants: 6-24 months: 1.25 mL (1/4 measuring spoon) of gel, applied four times a day after meals. Each dose should be divided into smaller portions and the gel should be applied to the affected area(s) with a clean finger. The gel should NOT be applied to the back of the throat due to possible choking. The gel should not be swallowed immediately, but kept in the mouth as long as possible. Adults and children 2 years of age and older: 2.5 mL (1/2 measuring spoon) of gel, applied four times a day after meals. The gel should not be swallowed immediately, but kept in the mouth as long as possible. The treatment should be continued for at least a week after the symptoms have disappeared. For oral candidosis, dental prostheses should be removed at night and brushed with the gel. _Gastrointestinal tract candidosis _ The gel may be used for infants (≥ 6 months of age), children, and adults who have difficult y swallowing tablets. The dosage is 20 mg per kg body weight per day, administered in 4 divided doses. The daily dose sho Lees het volledige document