Ülke: Malezya
Dil: İngilizce
Kaynak: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MICONAZOLE NITRATE
JNTL (MALAYSIA) SDN. BHD.
MICONAZOLE NITRATE
15gm mcg/mL; 30 gm mcg/mL
JANSSEN PHARMACEUTICA N.V.
DAKTARIN ® ORAL GEL _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ Miconazole Nitrate (20mg) WHAT IS IN THIS LEAFLET 1. What DAKTARIN ® Oral Gel is used for 2. How DAKTARIN ® Oral Gel works 3. Before you use DAKTARIN ® Oral Gel 4. How to use DAKTARIN ® Oral Gel 5. While you are using it 6. Side effects 7. Storage and Disposal of DAKTARIN ® Oral Gel 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT DAKTARIN ® ORAL GEL IS USED FOR DAKTARIN ® Oral Gel is used to treat fungal infections of the mouth, throat, stomach or intestines in adults and children 4 months and older. For a child between 4 and 6 months of age, be sure they do not have any swallowing problems before treating them with the oral gel. HOW DAKTARIN ® ORAL GEL WORKS Miconazole nitrate - an antifungal which works by destroying both the fungus that causes the infection and some of the associated bacteria which may also be present. BEFORE YOU USE DAKTARIN ® ORAL GEL - _When you must not use it _ • Infants less than 4 months of age or infants less than 5-6 months of age if the infant is pre-term or has problems swallowing due to risk of choking; • If you have any kind of liver disease; • If you are allergic to miconazole or to any of the other ingredients it contains; • If you are taking certain medicine(s) such as: o Allergy, namely terfenadine, astemizole and mizolastine; o Cisapride, a medicine used for certain digestive problems; o Certain medicines that lower your cholesterol, for example simvastatin and lovastatin; o Midazolam (by mouth) and triazolam, medicines that are taken for anxiety or to help you sleep (tranquilizers); o Pimozide and sertindole, medicines for certain psychiatric disorders; o Halofantrine, an antimalaria medicine; o Certain medicines used in the treatment of migraine, such as ergot alkaloids (Cafergot ® ); o Certain medicines used to treat irregular heartbeat, namely bepridil, quinidine, and dofetilide. Do not use DAKTARIN ® Oral Gel if you are on warfarin t Belgenin tamamını okuyun
PRODUCT NAME DAKTARIN ® ORAL GEL DOSAGE FORM AND STRE NGTHS W hite, homogeneous gel for oral use. Each gram contains 20 mg of miconazole. For excipients, see List of Excipients. CLINICAL INFORMATION Indications Treatment of candidosis of the oropharynge al cavity and the gastrointestinal tract in adults and pediatric patients 6 months and older (see Contraindications and Warnings and Precautions ). Dosage and Administration Oropharyngeal candidosis Infants: 6 -24 months: 1.25 mL (1/4 teaspoon ) of gel, appl ied four times a day after meals . Each dose is to be divided into smaller portions and the gel applied to the affected area(s) with a clean finger . The gel is not to 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 teaspoon ) of gel, applied four times a day after meals . The gel is not to be swallowed immediately, but kept in the mouth as long as possible. Continue t he treatment for at least a week after the symptoms have disappe ared. For oral candidosis, dental prostheses are to 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 difficulty swallowing tablets. The dosa ge is 20 mg per kg body weight per day, administered in 4 divided doses. The daily dose should not exceed 250 mg (10 mL Oral Gel) four times a day. Continue t he treatment for at least a week after the symptoms have disappeared. Contraindications DAKTARIN ® Oral Gel is contraindicated in the following situations: • In patients with hypersensitivity to miconazole , another ingredient of the formulation, or other imidazole derivatives. • In infants less than 6 months of age or in those whose swallowing reflex is not yet sufficiently developed . • In patients with liver dysfunction . • Use in combination with the following drugs that are subject to metabolism by CYP3A4: (See Interactions ) o Substrates known to prolong the QT -interval for exam Belgenin tamamını okuyun