VORISPORE 200MG IV

Pack Size

10ml

Dosage

How to use VORISPORE VORISPORE should only be used under the supervision of a doctor. You will not be expected to give yourself VORISPORE. It will be given to you by a person who is qualified to do so. Your doctor will decide what dose (depending on your weight) you should receive for your condition and also for how long you need to receive it. The dose and duration of treatment will depend on how your body and the infection reacts on the treatment. Usually you will be given 6 mg VORISPORE per kg body mass, every 12 hours for the first 24 hours and thereafter 4 mg/kg every 12 hours as maintenance dose. If you use efavirenz (for HIV) or phenytoin (anti-seizure medicine), your doctor may adapt your dosage. See “Other medicines and VORISPORE”. Your doctor or other healthcare provider will give you VORISPORE through a slow infusion (a drip for 1 to 2 hours) into one of your large veins. Before it is used, VORISPORE powder for solution for infusion will be reconstituted and diluted to the correct concentration by your hospital pharmacist or nurse. You may be switched from the intravenous infusion to tablets once your condition improves. If you have the impression that the effect of VORISPORE is too strong or too weak, tell your doctor or pharmacist.

Warnings and Contraindications

Women of childbearing potential If you are a woman of childbearing potential you must always use effective contraception during treatment. See “Pregnancy and breastfeeding”. Tell your doctor or healthcare professional before being given VORISPORE, if you: · are allergic to other azole type medicines (for example, fluconazole or ketoconazole which are antifungal medicines. Ask your doctor or pharmacist if you are unsure); · if there is a possibility that you can get pregnant (if you are of childbearing age). VORISPORE cannot be used to treat patients who are pregnant or breastfeeding. Your doctor will advise you on effective contraception; · are suffering from liver disease or have ever suffered from it. If you have liver disease, your doctor may prescribe a lower dose of VORISPORE. Your doctor should also monitor your liver function while you are being treated with VORISPORE by doing blood tests; · you are known to have cardiomyopathy (diseased heart muscle), irregular heartbeat, slow heart rate or an abnormality of electrocardiogram (ECG) called ‘long QTc syndrome’; · have a metabolic disorder such as low potassium, calcium or magnesium; · have a kidney disease. Depending on the degree of kidney disease the doctor may decide to rather give you voriconazole tablets. Your doctor should monitor your renal function while you are being treated with VORISPORE by doing blood tests.

Composition

· The active substance is voriconazole. Each vial contains 200 mg voriconazole, equivalent to a 10 mg/ml solution when reconstituted by your hospital pharmacist or nurse. · The other ingredients are hydroxypropyl-beta-cyclodextrin (HP-beta-CD), sodium chloride and hydrochloric acid (for pH adjustment). VORISPORE contains sodium Each vial of VORISPORE contains 225,6 mg sodium chloride, which provides 88,74 mg sodium (main component of cooking/table salt). Talk to your doctor or pharmacist if you need 6 or more vials daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.

PI / PIL