)בטיחות )מידע בטיחות החמרה (( מידע על החמרה הודעה על הודעה _22.12.10____ תאריך _________Tysabri_______שם תכשיר באנגלית _________136453150500 _______מספר רישום Medison Pharma Ltd___שם בעל הרישום השינויים בעלון מסומנים על רקע צהוב לרופא בעלון לרופא בעלון ים/ים המבוקש/פרטים על השינוי טקסט חדש טקסט נוכחי TYSABRI therapy is to be initiated and continuously supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions, in centres with timely access to MRI. TYSABRI therapy is to be initiated and continuously supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions, in centres with timely access to MRI. Patients treated with TYSABRI must be given the patient alert card and be informed about the risks of Tysabri (see also patient information leaflet). After 2 years of treatment, patients should be re-informed about the risks of Tysabri, especially the increased risk of PML, and should be instructed together with their caregivers on early signs and symptoms of PML. Patients treated with TYSABRI must be given the patient alert card and be informed about the risks of Tysabri (see also patient information leaflet). After 2 years of treatment, patients should be re-informed about the risks of Tysabri, especially the increased risk of PML, and should be instructed together with their caregivers on early signs and symptoms of PML. Resources for the management of hypersensitivity reactions and access to MRI should be available. Resources for the management of hypersensitivity reactions and access to MRI should be available. Patients can switch directly After dilution (see section 6.6), from beta interferon or the infusion is to be glatiramer acetate to administered over natalizumab providing there are approximately 1 hour and no signs of relevant patients are to be observed treatment-related abnormalities during the infusion and for e.g. neutropenia. If there are 1 hour after the completion of signs of treatment-related the infusion for signs and abnormalities these must return symptoms of hypersensitivity to normal before treatment with reactions. natalizumab is started. TYSABRI must not be פרק בעלון Posology and method of administration Some patients may have been exposed to immunosuppressive medications (e.g. mitoxantrone, cyclophosphamide, azathioprine). These drugs have the potential to cause prolonged immunosuppression, even after dosing is discontinued. Therefore the physician must confirm that such patients are not immunocompromised before starting treatment with TYSABRI (see also section 4.4). Posology Adults TYSABRI 300 mg is administered by intravenous infusion once every 4 weeks. administered as a bolus injection Patients can switch directly from beta interferon or glatiramer acetate to natalizumab providing there are no signs of relevant treatment-related abnormalities e.g. neutropenia. If there are signs of treatment-related abnormalities these must return to normal before treatment with natalizumab is started. Some patients may have been exposed to immunosuppressive medications (e.g. mitoxantrone, cyclophosphamide, azathioprine). These drugs have the potential to cause prolonged immunosuppression, even after dosing is discontinued. Therefore the physician must confirm that such patients are not immunocompromised before starting treatment with TYSABRI. Elderly TYSABRI is not recommended for use in patients aged over 65 due to a lack of data in this population. Children and adolescents Paediatric Population TYSABRI is contraindicated in children below the age of 18 years (see section 4.3). Method of Administration For instructions on dilution of the medicinal product before administration, see section 6.6. Adults TYSABRI 300 mg is administered by intravenous infusion once every 4 weeks. After dilution (see section 6.6), the infusion is to be administered over approximately 1 hour and patients are to be observed during the infusion and for 1 hour after the completion of the infusion for signs and symptoms of hypersensitivity reactions. TYSABRI must not be administered as a bolus injection. Children below the age of 18 years. Elderly TYSABRI is not recommended for use in patients aged over 65 due to a lack of data in this population. Children and adolescents TYSABRI is contraindicated in children and adolescents (see section 4.3). Contraindications Children and adolescents. Use of TYSABRI has been associated with an increased risk of PML which may be fatal or result in severe disability. The risk of PML increases with treatment duration, especially beyond 2 years. There is limited experience in patients who received more than 3 years of Tysabri treatment therefore the risk of PML in these patients cannot currently be estimated. The risk of PML is also increased in patients who have been treated with an immunosuppressant prior to receiving TYSABRI. This increased risk appears to be independent of TYSABRI treatment duration. Patients with a treatment history of immunosuppressant medications are at increased risk for PML. Fertility, pregnancy and lactation Women of childbearing potential There are no adequate data from the use of natalizumab in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Natalizumab should not be used during pregnancy unless clearly necessary. Use of TYSABRI has been associated with an increased risk of PML which may be fatal or result in severe disability. The risk of PML appears to increase with treatment duration, especially beyond 2 years. There is limited experience in patients who received more than 3 years of Tysabri treatment therefore the risk of PML in these patients cannot currently be estimated. Patients with a treatment history of immunosuppressant medications including cyclophosphamide and mitoxantrone, may experience prolonged immunosuppression and therefore may be are at increased risk for PML. There are no adequate data from the use of natalizumab in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Natalizumab should not be used during pregnancy unless clearly necessary. Special warnings and precautions for use Concurrent or prior treatment with immuno suppressants Pregnancy and lactation If a woman becomes pregnant while taking TYSABRI, discontinuation of TYSABRI should be considered. If a woman becomes pregnant while taking TYSABRI, discontinuation of TYSABRI should be considered. Pregnancy There are no adequate data from the use of natalizumab in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Natalizumab should not be used during pregnancy unless the clinical condition of the women requires treatment with TYSABRI. Breastfeeding It is not known whether TYSABRI is excreted in human milk, but it has been observed in animal studies (see section 5.3). Patients receiving TYSABRI should not breastfeed their infants. Fertility Reductions in female guinea pig fertility were observed in one study at doses in excess of the human dose; natalizumab did not affect male fertility. It is considered unlikely that natalizumab will affect fertility performance in humans following the maximum recommended dose. No studies on the effects on the ability to drive and use machines have been performed Based on the pharmacological mechanism of action of natalizumab, the use of TYSABRI has no or negligible influence on the is not expected to affect patient's It is not known whether TYSABRI is excreted in human milk, but it has been observed in animal studies (see section 5.3). Patients receiving TYSABRI should not breastfeed their infants. . Based on the pharmacological mechanism of action of natalizumab, the use of TYSABRI is not expected to affect patient's ability to drive and use machines. Effects on ability to drive and use machines ability to drive and use machines.