Country: অস্ট্রেলিয়া
ভাষা: ইংরেজি
সূত্র: Department of Health (Therapeutic Goods Administration)
itraconazole, Quantity: 10 mg/mL
Janssen-Cilag Pty Ltd
Oral Liquid, solution
Excipient Ingredients: propylene glycol; hydroxypropylbetadex; saccharin sodium; purified water; caramel; sorbitol solution (70 per cent) (non-crystallising); sodium hydroxide; hydrochloric acid; Flavour
Oral
150mL
(S4) Prescription Only Medicine
Sporanox oral solution is indicated for: * the treatment of oral and/or oesophageal candidiasis in HIV-positive or other immunocompromised patients. * prophylaxis of fungal infections in neutropenic patients.
Visual Identification: Clear, slightly amber to yellow solution, with a cherry odour.; Container Type: Bottle; Container Material: Glass Type I Coloured; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
1998-02-06
SPORANOX® ORAL SOLUTION (220211)CMI 1 SPORANOX ® ORAL SOLUTION _Itraconazole _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about SPORANOX Oral Solution. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking SPORANOX Oral Solution against the benefits this medicine is expected to have for you. If you have any concerns about taking SPORANOX Oral Solution, ask your doctor or pharmacist. Keep this leaflet with your medicine. You may need to read it again. WHAT SPORANOX ORAL SOLUTION IS USED FOR SPORANOX Oral Solution is a medicine used for: • the treatment of candida (yeast) infections of the mouth, throat and/or gullet in patients who have a lowered resistance to disease. • the prevention of fungal infections in certain patients who may have a lowered resistance. SPORANOX works by killing or stopping the growth of the fungus that causes the infection. 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. BEFORE YOU TAKE SPORANOX ORAL SOLUTION _WHEN YOU MUST NOT TAKE IT _ Do not take SPORANOX Oral Solution if: • you are pregnant or may become pregnant; • 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 at night. • you have an allergy to SPORANOX Oral Solution or any of the ingredients. See Product Description at the end of this leaflet. SPORANOX ORAL SOLUTION MUST NOT BE TAKEN WITH CERTAIN MEDICINES. PLEASE REFER TO THE SECTION 'BEFORE YOU START TO TAKE IT, TAKING OTHER MEDICINES.' FOR সম্পূর্ণ নথি পড়ুন
15.220321 Page 1 of 28 SPORANOXoralsoln(220617)API AUSTRALIAN PRODUCT INFORMATION SPORANOX (ITRACONAZOLE) ORAL SOLUTION 1. NAME OF THE MEDICINE Itraconazole 2. QUALITATIVE AND QUANTITATIVE COMPOSITION SPORANOX oral solution contains itraconazole 10 mg/mL. Excipients with known effect: saccharin; sorbitol (7.92 g in 40 mL of solution). Products containing sorbitol may have a laxative effect or cause diarrhoea. For a full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM Oral liquid, solution. SPORANOX oral solution is clear, slightly amber to yellow solution, with a cherry odour. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SPORANOX oral solution is indicated for: • the treatment of oral and/or oesophageal candidiasis in HIV-positive or other immunocompromised patients. • prophylaxis of fungal infections in neutropenic patients. 4.2 DOSE AND METHOD OF ADMINISTRATION SPORANOX oral solution should be taken on an empty stomach at least 1 hour before food. TREATMENT OF ORAL CANDIDIASIS: 200 mg (2 measuring cups or 20 mL) once a day or 100 mg (1 measuring cup or 10 mL) twice a day for 1 week. If there is no response after 1 week, treatment should be continued for another week. TREATMENT OF OESOPHAGEAL CANDIDIASIS 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 OESOPHAGEAL CANDIDIASIS: 200 mg (2 measuring cups, 20 mL) daily in one or two intakes for 2 weeks. If there is no response after 2 weeks the dose should be increased to 400 mg/day for a further 2 weeks. 15.220321 Page 2 of 28 SPORANOXoralsoln(220617)API PROPHYLAXIS OF FUNGAL INFECTIONS: 5 mg/kg per day administered as a twice daily dose until recovery of neutrophils for up to 8 weeks (see section 5.1 – PHARMACODYNAMICS – CLINICAL TRIALS – ANTIFUNGA সম্পূর্ণ নথি পড়ুন