Valsts: Eiropas Savienība
Valoda: angļu
Klimata pārmaiņas: EMA (European Medicines Agency)
tasonermin
Belpharma s.a.
L03AX11
tasonermin
Immunostimulants,
Sarcoma
Beromun is indicated in adults as an adjunct to surgery for subsequent removal of the tumour so as to prevent or delay amputation, or in the palliative situation, for irresectable soft-tissue sarcoma of the limbs, used in combination with melphalan via mild hyperthermic isolated-limb perfusion (ILP).
Revision: 15
Authorised
1999-04-12
20 B. PACKAGE LEAFLET 21 PACKAGE LEAFLET: INFORMATION FOR THE USER BEROMUN 1 MG POWDER FOR SOLUTION FOR INFUSION Tasonermin 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. - If you get any side effects , talk to your doctor. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. What Beromun is and what it is used for 2. What you need to know before you use Beromun 3. How to use Beromun 4. Possible side effects 5. How to store Beromun 6. Contents of the pack and other information 1. WHAT BEROMUN IS AND WHAT IT IS USED FOR Beromun contains the active substance tasonermin (tumor necrosis factor alfa-1a), produced by recombinant DNA technology. It belongs to a class of medicines known as immunostimulants, which help your body’s immune system fight cancer cells. Beromun is used, together with melphalan containing medicine, for the treatment of soft tissue sarcoma of the arms and legs. By reducing the size of the tumour, the treatment is intended to facilitate the removal of the tumor by surgery or to prevent severe damage to the surrounding healthy tissue and thus to delay or prevent the need for arm or leg amputation. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BEROMUN DO NOT USE BEROMUN - if you are allergic to tasonermin or any of the other ingredients of this medicine (listed in section 6). - if you have significant heart problems - if you have severe lung disease - if you have or have recently had a stomach ulcer - if you have too low numbers of blood cells or bleeding problems - if you have moderate to severe liver or kidney disease - if you cannot use vasopressors (used to increase low blood pressure), anticoagulants (used to prevent blood clotting) or radioactive tracers - if you are also using medicines with heart toxicity - if you have raised levels of calcium in your blood - if you have cer Izlasiet visu dokumentu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Beromun 1 mg powder for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 1 mg tasonermin*, corresponding to 3.0-6.0 x 10 7 IU (International Units). *tumor necrosis factor alfa-1a (TNFα-1a) produced by recombinant DNA technology in _E. coli_ . Excipient(s) with known effect: _ _ Each vial contains 20.12 mg (0.87 mmol) sodium. After reconstitution in 0.9 % physiological sodium chloride solution the amount is 37.82 mg (1.64 mmol) sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for infusion (powder for infusion). The powder is white to off-white. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Beromun is indicated in adults. as an adjunct to surgery for subsequent removal of the tumour so as to prevent or delay amputation, or in the palliative situation, for irresectable soft tissue sarcoma of the limbs, used in combination with melphalan via mild hyperthermic isolated limb perfusion (ILP). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION This treatment should be undertaken in specialised centres by surgical teams experienced in the management of limb sarcomas and ILP procedure, with an intensive care unit readily available and with the facilities for continuous monitoring for medicinal product leakage into the systemic circulation. Posology _Beromun: _ Upper limb: 3 mg total dose by ILP Lower limb: 4 mg total dose by ILP _Melphalan: _ Melphalan dose should be calculated according to the litre-volume method of Wieberdink (Wieberdink J, Benckhuysen C, Braat RP, van Slooten EA, Olthius GAA. Dosimetry in isolation perfusion of the limbs by assessments of perfused tissue volume and grading of toxic tissue reactions. _Eur J Cancer Clin Oncol_ 1982; 18: 905-910.), to a maximum dose of 150 mg. 13 mg/l perfused upper limb volume 10 mg/l perfused lower limb volume _Paediatric population_ The safety and efficacy of Beromun in children under 18 years have not bee Izlasiet visu dokumentu