Vorispore 200 mg Solution

VORISPORE is an antifungal medicine. It works by killing or stopping the growth of the fungi that cause infections. VORISPORE is used for the treatment of a wide variety of fungal infections in patients (adults and children over the age of 2). VORISPORE may also be used for the prevention of fungal infections in high risk bone marrow transplant recipients.

VORISPORE should not be administered to you:

• if you are hypersensitive (allergic) to voriconazole or any ingredient in VORISPORE (listed in section 6);
• if you have prolonged QT-syndrome (a heart rhythm disorder);
• if your liver function is severely affected;
• if you are pregnant or breastfeeding;

A list of the medicines that may affect VORISPORE is shown in the section “Other medicines and VORISPORE”. However, the medicines in the following list must not be taken during your course of VORISPORE treatment:

• Astemizole (used for allergy)
• Cisapride (used for stomach problems)
• Pimozide (used for treating mental illness)
• Quinidine (used for irregular heartbeat)
• Ergot alkaloids (e.g. ergotamine, dihydroergotamine; used for migraine)
• Rifampicin, rifabutin (used for treating tuberculosis)
• Efavirenz (used for treating HIV) in doses of 400 mg and above once daily
• Carbamazepine (used to treat seizures)
• Phenobarbital (phenobarbitone) (used for severe insomnia and seizures)
• Ritonavir (used for treating HIV) in doses of 400 mg and more twice daily
• Sirolimus (used in transplant patients)
• St. John’s Wort (herbal supplement used for depression).

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.

VORISPORE can have side effects. Not all side effects reported for VORISPORE are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving VORISPORE, please consult your healthcare provider for advice. If any of the following happens, stop using VORISPORE and tell your doctor immediately:

• Serious allergic reactions, including a shock reaction. You may have swelling of the tongue and/or throat, difficulty in swallowing, difficulties in breathing, facial swelling, severe dizziness with very fast heartbeat and heavy sweating.
• Allergic skin reactions (sometimes severe), including rapid swelling (oedema) of the dermis, subcutaneous tissue, mucosa and submucosal tissues, itchy or sore patches of thick, red skin with silvery scales of skin, irritation of the skin and mucous membranes, life threatening skin condition that causes large portions of the epidermis, the skin's outermost layer, to detach from the layers of skin below. These are all very serious side effects. If you have them, you may have had a serious reaction to VORISPORE. You may need urgent medical attention or further hospitalisation.
• Tell your doctor immediately if you notice any of the following:
• Jaundice (yellowing of the eyes or skin, dark urine, upper stomach pain), liver failure, gallbladder disease, gallstones.
• Deterioration of brain function that is a serious complication of liver disease.
• Inflammation of the pancreas (abdominal pain, fever, rapid pulse, nausea, shivering).
• Severe diarrhoea and nausea with fever and weakness. This is a serious condition for which you may need urgent treatment.
• Heart rhythm disturbances, including very fast heartbeat, very slow heartbeat, conduction problems (sometimes life threatening), fainting.
• Double vision, serious conditions of the eye including pain and inflammation of the eyes and eyelids, abnormal eye movement, damage to the optic nerve resulting in vision impairment, optic disc swelling.
• Disorder of blood clotting system (clotting in the blood vessels). Some signs of a blood clot in your arm or leg may be swelling, pain, a warm sensation, reddish discoloration. Some signs of a blood clot in your lungs may be sudden shortness of breath, chest pain, heart pain and coughing. Some signs of a blood clot in your brain may be sudden numbness or weakness in the face, arm or leg, confusion, trouble speaking.
• Guillain-Barré syndrome (the body’s immune system attacks part of the peripheral nervous system, with resulting muscle weakness, beginning in the feet and hands).
• Liver injury, inflammation of the liver. Some signs may be yellowing of the skin and eyes, nausea and fever.
• Kidney failure, inflammation in the kidney, blood in the urine, problems urinating, changes in kidney function tests, protein in the urine. These are all very serious side effects. If you have them, you may have had a serious reaction to VORISPORE. You may need urgent medical attention or hospitalisation.

Store all medicines out of reach of children. Store in the original carton at or below 25 °C. Reconstituted solutions: Once reconstituted, VORISPORE should be used immediately, but if necessary, may be stored for up to 72 hours at 2-8 °C or at room temperature (at or below 25 °C). Reconstituted VORISPORE needs to be diluted with a compatible infusion solution first before it is infused. Your healthcare professional will prepare and store the solution according to the directions on the professional information.