Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Itraconazole
Focus Pharmaceuticals Ltd
J02AC; J02AC02
Itraconazole
10 milligram(s)/millilitre
Oral solution
Product subject to prescription which may be renewed (B)
Triazole derivatives; itraconazole
Not marketed
2013-10-18
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 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, pharmacist or nurse. • 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, pharmacist or nurse. 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. WHAT ITRACONAZOLE ORAL SOLUTION IS AND WHAT IT IS USED FOR Itraconazole 10mg/ml Oral Solution (called Itraconazole Oral Solution throughout the rest of this leaflet) belongs to a group of antifungal medicines called triazole derivatives. Your medicine works by stopping growth of the fungus. This medicine is used: • to treat fungal infections which may occur in your mouth, throat or gullet, in patients who have HIV or a poorly functioning immune system. • to stop you from getting fungal infections, if your immune system is not working properly due to a reduced level of white blood cells (neutropenia), as a result of a blood disorder or a bone marrow transplant. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ITRACONAZOLE ORAL SOLUTION DO NOT TAKE ITRACONAZOLE ORAL SOLUTION • If you are allergic to itraconazole, or any of the other ingredients of this medicine (listed in section 6). • If you are pregnant, thinking of becoming pregnant or breastfeeding. • If you are taking any of the following medicines: ASTEMIZOLE, MIZOLASTINE or TERFENADINE (antihistamines for al Przeczytaj cały dokument
Health Products Regulatory Authority 19 October 2018 CRN008L3J Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ranitidine 50mg/2ml Solution for Injection and Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each one ml of solution contains 25mg ranitidine as ranitidine hydrochloride. Each 2ml ampoule contains 50mg ranitidine. Excipient(s) with known effect: Each ampoule contains 0.55mg (0.014mmol) of Potassium and 2.23mg (0.097mmol) of Sodium. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for Injection and Infusion Clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults Ranitidine Solution for Injection is indicated for the treatment of duodenal ulcer, benign gastric ulcer, post - operative ulcer, and of Zollinger - Ellison Syndrome. In the management of conditions where reduction of gastric secretion and acid output is desirable, such as reflux oesphagitis. As prophylaxis against: gastrointestinal haemorrhage from stress ulceration in seriously ill patients recurrent haemorrhage in patients with bleeding peptic ulcers acid aspiration (Mendelson's Syndrome) before anaesthesia in patients at risk, particularly obstetric patients during labour. Children (6 months to 18 years) short term treatment of peptic ulcer Health Products Regulatory Authority 19 October 2018 CRN008L3J Page 2 of 10 treatment of gastro-oesophageal reflux, including reflux oesophagitis and symptomatic relief of gastro-oesophageal reflux disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION See section 5.2 Pharmacokinetic Properties – Special Patient Populations Posology Adults (including elderly) and adolescents (12 years and older) Ranitidine Solution for Injection may be given as: a slow intravenous injection (over two minutes) up to a maximum of 50 mg, after dilution to a volume of 20 ml per 50 mg dose. This dose may be repeated every 6 to 8 hours or as an intermittent intravenous infusion at a rate of 25 mg per hour fo Przeczytaj cały dokument