देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
Itraconazole
Janssen Sciences Ireland UC
J02AC; J02AC02
Itraconazole
10 milligram(s)/millilitre
Oral solution
Triazole derivatives; itraconazole
Marketed
1997-09-05
Page 1 PACKAGE LEAFLET: INFORMATION FOR THE USER SPORANOX 10 MG/ML ORAL SOLUTION (itraconazole) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them even if their symptoms are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET 1. WHAT SPORANOX ORAL SOLUTION IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SPORANOX ORAL SOLUTION 3. HOW TO USE SPORANOX ORAL SOLUTION 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE SPORANOX ORAL SOLUTION 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT SPORANOX ORAL SOLUTION IS AND WHAT IT IS USED FOR SPORANOX is one of a group of medicines called “antifungals”. These medicines are used to treat and stop you from getting infections caused by fungi including yeasts. You may be given SPORANOX to : • treat yeast infections of the mouth, throat or gullet if you have a poor immune system • stop you from getting certain fungal infections if you have a poor immune system due to a major blood disorder or bone marrow transplantation. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SPORANOX ORAL SOLUTION DO NOT USE SPORANOX ORAL SOLUTION: • If you are allergic (hypersensitive) to any of the ingredients in SPORANOX oral solution (listed in Section 6) • If you are pregnant, think you might be pregnant or could become pregnant (see the section on Pregnancy) Tell your doctor if you are taking any medicines, before you use SPORANOX oral solution. • DO NOT USE SPORANOX ORAL SOLUTION IF you are taking certain medicines, or within 2 weeks of stopping SPORANOX oral solution. The following list contains examples of medicines you must not take with SPORANOX oral solutio पूरा दस्तावेज़ पढ़ें
HealthProductsRegulatoryAuthority 19October2023 CRN00DFD9 Page1of20 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sporanox10mg/mLoralsolution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1mLSPORANOXOralSolutioncontains10mgitraconazole. Excipients with known effect EachmLofSPORANOXOralSolutioncontains: 400 mghydroxypropyl-β(cyclodextrin); 198 mgsorbitol; 104 mgpropyleneglycol; 0.005 mgethanol. Forthefulllistofexcipients,seesection6.1. 3 PHARMACEUTICAL FORM Oralsolution. Sporanoxoralsolutionisclear,yellowtoslightlyambersolutionwithanodourofcherry. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SPORANOXOralSolutionisindicated: forthetreatmentoforaland/oroesophagealcandidosisinHIV-positiveorotherimmunocompromisedpatients.as prophylaxisofdeepfungalinfectionsanticipatedtobesusceptibletoitraconazole,whenstandardtherapyis consideredinappropriate,inpatientswithhaematologicalmalignancyorundergoingbonemarrowtransplant,and whoareexpectedtobecomeneutropenic(i.e.<500cells/µL).Atpresent,thereareinsufficientclinicalefficacydata inthepreventionofaspergillosis. Considerationshouldbegiventonationaland/orlocalguidanceregardingtheappropriateuseofantifungalagents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Foroptimalabsorption,SPORANOXOralSolutionshouldbetakenwithoutfood(patientsareadvisedtorefrainfromeatingfor atleast1hourafterintake). Forthetreatmentoforaland/oroesophagealcandidosis,theliquidshouldbeswishedaroundtheoralcavity(approx.20 seconds)andswallowed.Thereshoul पूरा दस्तावेज़ पढ़ें