Страна: Малайзия
Език: английски
Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ITRACONAZOLE
JOHNSON & JOHNSON SDN BHD
ITRACONAZOLE
150ml mL
JANSSEN PHARMACEUTICA N.V.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ SPORANOX ® ORAL SOLUTION Itraconazole 10mg/mL WHAT IS IN THIS LEAFLET 1. What SPORANOX ® is used for 2. How SPORANOX ® works 3. Before you use SPORANOX ® 4. How to use SPORANOX ® 5. While you are using it 6. Side effects 7. Storage and Disposal of SPORANOX ® 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT SPORANOX ® IS USED FOR SPORANOX oral solution is a medicine used: • to treat yeast infections of the mouth, throat and foodpipe (esophagus) in people with a lowered resistance; • to prevent certain fungal infections in people who may have a lowered resistance due to a major blood disorder or bone marrow transplantation. Your doctor may have prescribed SPORANOX Oral Solution for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you. HOW SPORANOX ® WORKS SPORANOX works by killing or stopping the growth of the fungus that causes the infection. BEFORE YOU USE SPORANOX ® - _When you must not use it _ Do not take SPORANOX oral solution: • if you know you are hypersensitive (allergic) to it; • if you are pregnant (unless your doctor knows you are pregnant and decides you need SPORANOX); • if you are of child bearing age and could become pregnant, you should take adequate contraceptive precautions to make sure that you do not become pregnant while you are taking your medicine. As SPORANOX remains in the body for some time after you stop taking it, you should continue to use contraception until your next period after your treatment with SPORANOX oral solution is finished. • if you have a condition called heart failure (also called congestive heart failure or CHF), SPORANOX could make it worse. If your doctor decides that you need to take SPORANOX even if you have this condition, be sure to get immediate medical help if you have shortness of breath, unexpected weight gain, swelling of the legs, unusual fatigue, or begin to wake up Прочетете целия документ
1 PRODUCT NAME SPORANOX ® Oral Solution SPORANOX Oral Solution contains the bactericidal and fungicidal broad-spectrum antifungal agent. It is a yellow to slightly amber, clear solution with cherry flavor. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 mL SPORANOX Oral Solution contains 10 mg itraconazole. For excipients, see _List of Excipients_ . PHARMACEUTICAL FORM Oral solution. SPORANOX Oral Solution is clear. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS SPORANOX Oral Solution is indicated: • For the treatment of oral and/or esophageal candidosis in HIV-positive or other immunocompromised patients. • As prophylaxis of deep fungal infections when standard therapy is considered in appropriate in patients with hematological malignancy or undergoing bone marrow transplant, and who are expected to become neutropenic (i.e., < 500 cells/µL). At present there are insufficient data on clinical efficacy in the prevention of aspergillosis. DOSAGE AND ADMINISTRATION For optimal absorption, SPORANOX Oral Solution should be taken without food (patients are advised to refrain from eating for at least 1 hour after intake). For the treatment of oral and/or esophageal candidosis, _ _ the oral solution should be swished around the oral cavity (approx. 20 seconds) and swallowed. There should be no rinsing after swallowing. TREATMENT OF ORAL CANDIDOSIS 200 mg (2 measuring cups, i.e. 20 mL) per day in two intakes, or alternatively in one intake, for 1 week. If there is no response after 1 week, treatment should be continued for another week. TREATMENT OF ESOPHAGEAL CANDIDOSIS 100 mg (1 measuring cup, i.e. 10 mL) daily for a minimum treatment of three weeks. Treatment should continue for 2 weeks following resolution of symptoms. Doses up to 200 mg (2 measuring cups, i.e. 20 mL) per day may be used based on the clinical response of the patient. TREATMENT OF FLUCONAZOLE RESISTANT ORAL AND/OR ESOPHAGEAL CANDIDOSIS 2 100 to 200 mg (1 - 2 measuring cups) twice daily for 2 weeks. If there is no response after 2 weeks, treatment should Прочетете целия документ