Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
palifermin
Swedish Orphan Biovitrum AB (publ)
V03AF08
palifermin
All other therapeutic products
Mucositis
Kepivance is indicated to decrease the incidence, duration and severity of oral mucositis in adult patients with haematological malignancies receiving myeloablative radiochemotherapy associated with a high incidence of severe mucositis and requiring autologous-haematopoietic-stem-cell support.
Revision: 19
Withdrawn
2005-10-25
19 B. PACKAGE LEAFLET Medicinal product no longer authorised 20 PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ KEPIVANCE 6.25 MG POWDER FOR SOLUTION FOR INJECTION palifermin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 or pharmacist. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Kepivance is and what it is used for 2. What you need to know before you use Kepivance 3. How to use Kepivance 4. Possible side effects 5. How to store Kepivance 6. Contents of the pack and other information 1. WHAT KEPIVANCE IS AND WHAT IT IS USED FOR Kepivance contains the active substance palifermin which is a protein produced by biotechnology in a bacteria called _Escherichia coli_ . Palifermin stimulates the growth of specific cells called epithelial cells that form the tissue lining of your mouth and digestive tract, as well as other tissues such as skin. Palifermin works in the same way as keratinocyte growth factor (KGF) which is made naturally by your body in small amounts. Kepivance is used to treat oral mucositis (soreness, dryness and inflammation of the mouth) which has occurred as a side effect of treatments for your blood cancer. To treat your blood cancer you may be receiving chemotherapy, radiotherapy and autologous hematopoietic stem cell transplantation (cells from your own body that produce blood cells). One of the side effects of these treatments is oral mucositis. Kepivance is used to reduce the frequency, duration and severity of oral mucositis symptoms. Kepivance should only be used in adults over the age of 18 years. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE KEPIVANCE _ _ DO NOT USE KEPIVANCE: - if you are allergic to palifermin, _Escherichia coli_ derived proteins or any other ingredients of this medic Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS_ _ Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Kepivance 6.25 mg powder for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 6.25 mg of palifermin. Palifermin is a human keratinocyte growth factor (KGF), produced by recombinant DNA technology in _Escherichia coli_ . Once reconstituted, Kepivance contains 5 mg/ml of palifermin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection (powder for injection). White lyophilised powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Kepivance is indicated to decrease the incidence, duration and severity of oral mucositis in adult patients with haematological malignancies receiving myeloablative radiochemotherapy associated with a high incidence of severe mucositis and requiring autologous haematopoietic stem cell support. _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Kepivance treatment should be supervised by a physician experienced in the use of anti-cancer therapy. Posology _Adults _ The recommended dosage of Kepivance is 60 micrograms/kg/day, administered as an intravenous bolus injection for three consecutive days before and three consecutive days after myeloablative radiochemotherapy for a total of six doses. The duration between last dose of Kepivance before myeloablative radiochemotherapy and the first dose of Kepivance after myeloablative radiochemotherapy should be at least seven days. _Pre-_ _myeloablative radiochemotherapy:_ The first three doses should be administered prior to myeloablative _ _ therapy, with the third dose 24 to 48 hours before myeloablative _ _ radiochemotherapy. _Post-_ _myeloablative radiochemotherapy: _ The last three doses should be administered post myeloablative _ _ radiochemotherapy; the first of these doses should be administered after, but on the same day of haematopoietic stem cell infusion and at least seven days after the most recent Kepivance administration (se Lesen Sie das vollständige Dokument