5 ml vial contains 250 microgram palonosetrone (Each of ml solution contains 50 microgram palonosetrone).
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1 PATIENT INFORMATION LEAFLET VOTRON 250 µg/5 ml vial For IV injection of solution For intravenous usage. Active ingredient: Palonosetrone (as hydrochloride). 5 ml vial contains 250 microgram palonosetrone (Each of ml solution contains 50 microgram palonosetrone). Excipients: Mannitole, trisodium citrate, citric acide monohydrate, water for injections, solution of sodium hydroxide and solution of hydrochloric acide. Before using this medicine, please read carefully this patient information leaflet, because it contains important information for you. *Save this patient information leaflet. You need read again later. *If you have additional questions, please consult to your doctor or pharmaciest. *This medicine is prescribed for you indivudually, do not give to other people. *During usage of this medicine and when you g oto the doctor or hospital, please tell to doctor to be used this medicine. *Please follow this patient information leaflet exactly. Except recommended dosage for you, do not use high or low doses. In this patient information leaflet: 1. What is VOTRON and what is used for? 2. Precautions before using of VOTRON, 3. How is VOTRON using? 4. What is possible side effects? 5. Storage of VOTRON Heads are availible. 1.What is VOTRON and what is used for? * VOTRON is colorless solution administered by intravenously and it is included in medicine group known seratonin antagonists (5 HT 3 ). *VOTRON is packaged in 5 ml vial containing 5 ml solution. Each vial contains one dosage. *VOTRON is used for prevention nausea and vomiting related to treatment of cancer with medicines (chemotherapy).
2 2. Precautions before usage of VOTRON Do not use VOTRON for following situations: If you have hypersensitive to palonosetrone or other constituents of VOTRON (alergic) (refer to list of excipients). Use VOTRON carefully for following situations: If; You have acute obstruction of large intestine or repeated constipation history, use carefully. You have taken VOTRON with other medicines whic causes abnormal cardiac ritms, use carefully. If this precautions are valid also in the past, please consult to your doctor. Using VOTRON with food and drinks: With regard to application route, there is no interaction with food and drinks. Pregnancy Before using this medicine, consult to your doctor or pharmaciest. There is no enough data related to usage of VOTRON in pregnant women. Othervise necessity not described by doctor, VOTRON must not use during pregnancy. If you have noticed that you are pregnant during treatment, immediately consult to your doctor. Lactation Before using of this medicine, please consult to your doctor. It is not known whether VOTRON excreted to mother milk or not. If usage of medicine is not absolute, lactation is stopped during treatment. Driving and machinery usage There is no any study in related to its effects on capability of driving and machinary usage. Since palonosetrone causes dizziness, insomnia and weakness, please be careful when driving and using machinery. Important information about excipients which are availible in VOTRON: If you have not hyper sensivity to constituents in VOTRON, negative effects are not expected related to these substances. Usage of other medicines: There is no limittation for using of VOTRON with other medicines.
3 If you are using prescribed or non prescribed medicines, please inform to your doctor about these medicines. 3.How is using VOTRON? Instructions for suitable usage and dosage/administration frequency: VOTRON is administered by intravenously by your doctor or nurse before approximately 30 minutes from starting of chemotherapy. Administration method and route: Use by intravenous injection. Your doctor or nurse will inject VOTRON approximately before 30 minutes from starting of chemotherapy. 250 microgram VOTRON is given by rapid injection and by intravenously. Remaining parts fron opened vial must discarded. Different age groups: Usage in children: It is not recommended usage of VOTRON for children below 18 years of age. Usage in geriatric patients: Dosage arrangement does not necessary for geriatrics and use at recommended dosage by your doctor. Special usage conditions: Renal/liver insufficiencies: In patients with renal function insufficiency, special dose arrangement does not necessary except for recommended dosage of your doctor. For hemodialysed patients and patients with advanced stage of renal disease, there is no any data, so, please consult to your doctor. Patients with liver insufficiency, dose arrangement is not necessary except for recommended dosage by your doctor. Othervise not described by your doctor, follow this instructions. Take tour medicine on time. Your doctor inform you about timelines of treatment with VOTRON. Do not stop treatment early, because you do not receive expected results. If you have been noticed that effects of VOTRON is too strong or too weak, please speak with your doctor or pharmaciest.
4 If you have been used more than required dosage of VOTRON: If you have been used VOTRON too much from recommended dosage, speak to your doctor or pharmaciest. If you have been forgot to take VOTRON: Your doctor will decide time of next dose. To follow instructions of your doctor about new administration time of next dose is important. Possible effects occured after finishing treatment with VOTRON: There was no effects. 4. What is possible side effects? Like all other medicines, side effects can seen person who sensitive to constituents of VOTRON. If you have been noticed followings, please stop usage of VOTRON and IMMEDIATELY inform to your doctor or go to hospital of emergency service: Rash on skins, Redness, All of them are very serious side effects. If you any of them is availible for you, you are alergic to VOTRON. Emergency medical treatment or hospital care can require. All of these serious side effects are seen very rarely. If you have been noticed followings, immediately inform to your doctor or go to hospital of emergency division: Changes of cardiac ritms, if you notice more or less cardiac ritms, Mobility of hypertension; if it is too high or too low, High temperature, Oligouria, Changing of vascular color. All of these are serious side effects. Immediate medical care can require. Serious side effects are seen very rarely. If you have been noticed followings, please tell to your doctor: Nausea when driving, Tinnitus, Visual disturbances, Diarree, Abdominal pain, Dryness in mounth,
5 Hiccups, Dispepsia, Weakness, Tiredness, Loss of apetite, Headache, Change of sleeping time; example insomnia or somnia, Flu, Nervousness, Pain at joins, Oedema. These are light side effects of VOTRON. If you have been noticed other side effects which are not described in this patient information leaflet, inform to your doctor or pharmaciest. 5.Storage of VOTRON: Store VOTRON at places where children can not see or reach. Store VOTRON below 25 0 C at room temperature protecting from light and humudity. Do not freze VOTRON. If medicine is freezed, do not dissolve and use. For single usage only. Remaining solution from vial must discarded. Use suitable with its expiry date. Do not use VOTRON after expiry date written on the packaging. If you have any deteriotation on the product or packaging, do not use VOTRON. Registration holder: Biem Medical Device and Pharmaceuticals Co.Ltd. Anıttepe Mah., Turgut Reis Cad. No: Tandoğan ANKARA/TURKEY Phone: (0312) Fax: (0312) This patient information leaflet is approved on 25/11/2013.
SUMMARY OF PRODUCT CHARACTERISTICS. Each of Votron 5 ml vial contains 250 microgram palonosetrone (as hydrochloride).
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