国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Itraconazole
Athlone Pharmaceuticals Limited
J02AC; J02AC02
Itraconazole
Oral solution
Triazole derivatives; itraconazole
Marketed
2013-05-10
PACKAGE LEAFLET: INFORMATION FOR THE USER ITRACONAZOLE 10MG/ML ORAL SOLUTION 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 signs of illness 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. See section 4. WHAT IS IN THIS LEAFLET: 1. What Itraconazole Oral Solution is and what it is used for 2. What you need to know before you take Itraconazole Oral Solution 3. How to take Itraconazole Oral Solution 4. Possible side effects 5. How to store Itraconazole Oral Solution 6. Contents of the pack and other information 1. W HAT I TRACONAZOLE ORAL SOLUTION IS AND WHAT IT IS USED FOR Itraconazole 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 this medicine: • To treat yeast infections of the mouth, throat or food pipe (oesophagus) if you have a poor immune system • To stop you from getting certain fungal infections if you have blood cancer or have had a bone marrow transplant and have a poor immune system. 2. W HAT YOU NEED TO KNOW BEFORE YOU TAKE I TRACONAZOLE ORAL SOLUTION DO NOT USE ITRACONAZOLE ORAL SOLUTION IF YOU: • ARE ALLERGIC (hypersensitive) to itraconazole or any of the other ingredients (listed in section 6 Contents of the pack and other information) • have, or have a history of, congestive heart failure, unless you have a very serious fungal infection • ARE PREGNANT, think you might be pregnant or could become pregnant (see the section on Pregnancy) Do not use this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pha 完全なドキュメントを読む
Health Products Regulatory Authority 17 November 2023 CRN00DXZV Page 1 of 23 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Itraconazole 10mg/ml oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml Itraconazole oral solution contains 10mg itraconazole. Excipients with known effect: Each ml of Itraconazole oral solution contains 247mg of sorbitol E420, 400 mg hydroxypropyl-β (cyclodextrin), 103.6mg of propylene glycol (E 1520). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution. Itraconazole oral solution is a clear, yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Itraconazole oral solution is indicated: For the treatment of oral and/or oesophageal candidosis in HIV-positive or other immunocompromised patients. As prophylaxis of deep fungal infections anticipated to be susceptible to itraconazole, when standard therapy is considered inappropriate, in patients with haematological malignancy or undergoing bone marrow transplant, and who are expected to become neutropenic (i.e. < 500 cells/microlitre). At present there are insufficient clinical efficacy data in the prevention of aspergillosis. Itraconazole oral solution is indicated for use in adults. Consideration should be given to national and/or local guidance regarding the appropriate use of antifungal agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For optimal absorption, Itraconazole oral solution should be taken without food (patients are advised to refrain from eating for at least 1 hour after intake). A graduated measuring cup is provided to measure out the correct dose. For the treatment of oral and/or oesophageal candidosis, the liquid should be swished around the oral cavity (approx. 20 seconds) and swallowed. There should be no rinsing after swallowing. Treatment of oral and/or oesophageal candidosis: 200 mg (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 完全なドキュメントを読む