Pays: Nouvelle-Zélande
Langue: anglais
Source: Medsafe (Medicines Safety Authority)
Miconazole 20 mg/g;
JNTL Consumer Health (New Zealand) Limited
Miconazole 20 mg/g
2% w/w
Oral gel
Active: Miconazole 20 mg/g Excipient: Ethanol Cocoa Glycerol Orange flavour Polysorbate 20 Potato starch Purified water Saccharin sodium
Tube, aluminium, 15g, 15 g
Restricted
Restricted
Janssen Pharmaceutical Sciences Unlimited Company (JPSUC)
DAKTARIN oral gel is indicated for the treatment of clinically significant oral and gastrointestinal candidiasis.
Package - Contents - Shelf Life: Tube, aluminium, - 15 g - 36 months from date of manufacture stored at or below 30°C - Tube, aluminium, - 30 g - 36 months from date of manufacture stored at or below 30°C - Tube, aluminium, - 40 g - 36 months from date of manufacture stored at or below 30°C
1980-11-27
CONSUMER MEDICINE INFORMATION DAKTARIN ® MICONAZOLE 20 mg/g Oral Gel WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about DAKTARIN Oral Gel. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. If you have any concerns about using DAKTARIN Oral Gel, ask your doctor or pharmacist. Your doctor and pharmacist have more information. Keep this leaflet with your DAKTARIN Oral Gel. You may need to read it again. WHAT DAKTARIN ORAL GEL IS USED FOR DAKTARIN Oral Gel is used to treat infections of the mouth and throat (e.g. thrush). DAKTARIN Oral Gel is an antifungal. These medicines work by treating infections caused by fungi, including yeast. Your doctor may have prescribed DAKTARIN Oral Gel for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you. BEFORE YOU USE DAKTARIN ORAL GEL _WHEN YOU MUST NOT USE IT _ Do not use DAKTARIN Oral Gel if you know you are allergic to any of the ingredients. (See the last section of this leaflet for a list of ingredients). Signs of allergy include a skin rash, itching, shortness of breath and/or a swollen face, lips, tongue or other parts of the body. Do not use DAKTARIN Oral Gel if you have liver disease. DAKTARIN Oral Gel could make the symptoms of your liver disease worse. Do not give DAKTARIN Oral Gel to an infant below the age of 6 months. The safety of this medicine in infants under 6 months of age has not been established. Do not use DAKTARIN Oral Gel if the packaging is torn or shows signs of tampering. Do not use DAKTARIN Oral Gel beyond the expiry date (month and year) printed on the pack. Do not use DAKTARIN Oral Gel if you are taking any of the following medicines because it may affect the way these medicines work: • cisapride (used for digestive problems) • simvastatin or lovastatin (used to low Lire le document complet
DATA SHEET 1. PRODUCT NAME DAKTARIN® Oral Gel 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram contains 20 mg of miconazole. The other ingredients are glycerol, purified water, pregelatinised potato starch, ethanol, polysorbate 20, sodium saccharin, orange flavour, and cocoa flavour. For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM A white, homogenous, orange-flavoured oral gel. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DAKTARIN® oral gel is indicated for the treatment of clinically significant oral and gastrointestinal candidiasis. 4.2 DOSE AND METHOD OF ADMINISTRATION Dose: Infants: For infants 6-24 months, one quarter ( 1 / 4 ) of a measuring spoon* of gel four times daily, or 20 mg/kg/day is recommended. Children (2 years of age and older) and Adults: Half ( 1 / 2 ) a measuring spoon* of gel four times daily. * A measuring spoon (5 mL) is provided with the gel. One spoonful contains approximately 124 mg of miconazole. All spoonful dose volumes should be administered with this spoon. Method of administration: DAKTARIN® oral gel should be placed on the tongue and kept in mouth for as long as possible before swallowing. When treating infants and younger children it is recommended that the measured dose of gel be given in several portions in the front of the mouth. Avoid dosing to the back of the throat to prevent obstruction. With oral thrush in elderly patients where a contributing cause is the dental prosthesis it is recommended that DAKTARIN® oral gel be applied directly to the dentures in the evening and left on overnight. The treatment should be continued for at least one week after the symptoms have disappeared and generally until all clinical and mycological laboratory tests no longer indicate that active fungal infection is present. 4.3 CONTRAINDICATIONS DAKTARIN® Oral Gel is contraindicated in the following situations: • In patients with a known hypersensitivity to miconazole or to any of the other ingredients of the gel or other imidazole derivatives. • In in Lire le document complet