FrancophonIA/ELRC3.0 huggingface dataset:
English: Compartment syndrome, myalgia
Slovenian: utesnitveni sindrom, mialgija
English: If there is any risk of serious side effects, your doctor will immediately transfer you to an intensive care unit to closely monitor you and start adequate treatment.
Slovenian: Če obstaja tveganje za resne neželene učinke, vam bo zdravnik takoj preusmeril na oddelek za intenzivno nego, da pozorno spremlja in uvede ustrezno zdravljenje.
English: After lower limb perfusion, 3 to 6 litres should be used, and after upper limb perfusion, 1 to 2 litres.
Slovenian: Po perfuziji spodnje okončine moramo uporabiti 3 do 6 litrov, po perfuziji zgornje okončine pa 1 do 2 litra.
English: It is important to maintain a constant level of anaesthesia in order to prevent large fluctuations in systemic blood pressure, which can affect leakage between systemic circulation and perfusion circuit.
Slovenian: Pomembno je vzdrževati enakomerno globino anestezije, da bi preprečili velika nihanja sistemskega krvnega tlaka, zaradi katerih lahko pride do puščanja med sistemskim obtokom in perfuzijskim krogotokom.
English: The synthesis capacity of the liver was lowered as indicated by increased liver enzymes.
Slovenian: Zmanjšala se je zmogljivost sinteze v jetrih, kar je pokazalo povečanje jetrnih encimov.
English: If there is significant systemic leakage of Beromun
Slovenian: Če pride do večjega sistemskega uhajanja zdravila Beromun
English: What you need to know before you use Beromun Do not use Beromun
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Beromun Ne uporabljajte zdravila Beromun
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja po rekonstrukciji zdravila glejte poglavje 6.3.
English: Beromun is contraindicated in pregnancy (see section 4.3).
Slovenian: Zdravilo Beromun je kontraindicirano med nosečnostjo (glejte poglavje 4.3).
English: Measures should be taken to ensure that the periods of interrupted oxygen supply to the limb are as brief as possible (20 minutes maximum).
Slovenian: Z ustreznimi ukrepi moramo zagotoviti, da bo oskrba okončine s kisikom prekinjena čim krajši čas (največ
English: It belongs to a class of medicines known as immunostimulants, which help your body's immune system fight cancer cells.
Slovenian: Sodi v skupino zdravil, ki jih imenujemo imunostimulansi, in pomaga imunskemu sistemu v boju proti rakastim celicam.
English: What Beromun is and what it is used for What you need to know before you use Beromun How to use Beromun
Slovenian: Kaj je zdravilo Beromun in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Beromun Kako uporabljati zdravilo Beromun
English: Each vial contains 1 mg tasonermin.
Slovenian: Ena viala vsebuje 1 mg tasonermina.
English: Pharmacotherapeutic group: Other immunostimulants, ATC code: L03AX11
Slovenian: Farmakoterapevtska skupina: drugi imunostimulansi, oznaka ATC: LO3A X11 Mehanizem delovanja
English: Renal and hepatic function should be closely monitored.
Slovenian: Natančno je treba spremljati ledvično in jetrno funkcijo.
English: This will occur whilst you are unconscious, under the influence of a general anaesthetic.
Slovenian: Prejeli ju boste, ko boste med splošno anestezijo brez zavesti.
English: The perfusion circuit (roller pump, oxygenator with integrated reservoir, heat exchanger, connecting tubing) should be prepared prior to surgery and primed with 700 to 800 ml of perfusate, with haematocrit of 0.25 to 0.30.
Slovenian: Perfuzijski sistem (valjčna črpalka, oksigenator z vgrajenim rezervoarjem, toplotni izmenjevalec, povezovalne cevke) je treba pripraviti pred kirurškim posegom in ga napolniti s 700 do 800 ml perfuzijske raztopine, s hematokritom 0,25 do 0,30.
English: For the prophylaxis of shock, patients should always be maximally hydrated prior to, during and after the perfusion procedure.
Slovenian: Da bi preprečili šok, morajo biti bolniki optimalno hidrirani pred in med perfuzijo ter po njej.
English: If Beromun dry powder or reconstituted solution should come into contact with the skin or mucous membranes, they should be washed thoroughly with water.
Slovenian: Če prašek zdravila Beromun ali pripravljena raztopina prideta v stik s kožo ali sluznico, jih je treba temeljito umiti z vodo.
English: Abdominal pain upper, gastritis erosive
Slovenian: bolečina v zgornjem abdomnu, erozivni gastritis
English: This is to ensure optimal haemodynamic conditions and ensure a high urinary output, especially after the perfusion, to allow for rapid clearance of any residual tasonermin.
Slovenian: S tem zagotovimo optimalne hemodinamične razmere in povečamo izločanje seča, zlasti po perfuziji, da bi se preostanek tasonermina hitro izločil.
English: In approximately 2% of cases, Beromun may cause tissue damage in your affected arm or leg which is severe enough to require amputation.
Slovenian: Pri približno 2 % primerov lahko povzroči zdravilo Beromun poškodbe tkiva v prizadeti roki ali nogi, ki so tako hude, da je potrebna amputacija.
English: Washout should be continued until the colour of the perfusate is clear pink, transparent (see section 4.4).
Slovenian: Izpirati je treba, dokler ne postane perfuzijska raztopina čista, rožnata in prozorna; glejte poglavje 4.4).
English: From a microbiological point of view, the reconstituted product should be used immediately.
Slovenian: Iz mikrobioloških razlogov je treba pripravljeno zdravilo takoj uporabiti.
English: Several lines of evidence suggest that these immunomodulatory activities are of relevance for the antitumour effects; e.g. the antitumour activities of tasonermin are much less pronounced in immunodeficient animals.
Slovenian: Precej podatkov kaže, da so našteti imunomodulacijski učinki pomembni za protitumorsko delovanje; protitumorsko delovanje tasonermina je na primer veliko manj izrazito pri imunodeficitnih živalih.
English: It is not known whether tasonermin is excreted in human milk.
Slovenian: Dojenje Ni znano, ali se tasonermin izloča v materino mleko.
English: These include standard anaesthetic agents, analgesics, antipyretics, intravenous fluids, anticoagulants and vasopressor agents.
Slovenian: To so standardne učinkovine za anestezijo, analgetiki, antipiretiki, intravenske tekočine, antikoagulansi in vazopresorne učinkovine.
English: The reason for the differential sensitivity of the tumour vasculature (high) versus normal vasculature (low) are currently unknown.
Slovenian: Vzrok za različno občutljivost žilja v tumorju (ki je velika) in normalnega žilja (ki je majhna) še ni znan.
English: - 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 certain infections which do not respond to antibiotics - if you have severe swelling of the affected arm or leg due to local fluid build-up, or severe fluid build-up in the abdomen - if you are pregnant or planning to become pregnant.
Slovenian: - če imate hujše srčne težave, - če imate hudo pljučno bolezen, - če imate ali ste pred kratkim imeli želodčno razjedo, - če je pri vas število krvnih celic premajhno ali imate težave s krvavitvami, - če imate zmerno hudo do hudo jetrno ali ledvično bolezen, - če ne smete prejeti vazopresornih zdravil (s katerimi povečamo nizek krvni tlak), antikoagulansov (s katerimi preprečujemo nastajanje krvnih strdkov) ali radioaktivnih sledil; - če se sočasno zdravite z zdravili, ki lahko toksično delujejo na srce; - če imate povečano raven kalcija v krvi, - če imate določene okužbe, ki se ne odzivajo na antibiotike; - če je vaša prizadeta roka ali noga močno otečena zaradi nabiranja tekočine v prizadetem predelu ali se nabira veliko tekočine v trebušni votlini, - če ste noseči ali nosečnost načrtujete,
English: In order to minimise the risk of leakage of the perfusate into the systemic circulation, the perfusion flow rate should not exceed 40 ml/litre limb volume/minute.
Slovenian: Da bi nevarnost uhajanja perfuzijske raztopine v sistemski obtok, kolikor je možno zmanjšali, hitrost pretoka perfuzijske tekočine ne sme prekoračiti 40 ml/l volumna okončine/minuto.
English: Upon reconstitution the product should be used immediately.
Slovenian: Po pripravi je treba zdravilo uporabiti takoj.
English: Perfusion level should be chosen to adequately encompass affected tissue (external iliac, common femoral, femoro-popliteal, popliteal, axillary and brachial being accepted routes) and catheters introduced.
Slovenian: Določiti je treba tolikšno raven perfuzije, da bo ustrezno zajela prizadeto tkivo (sprejete poti so zunanja iliakalna, skupna femoralna, femoro-poplitealna, poplitealna, aksilarna in brahialna), in vstaviti katetre.
English: The reconstituted medicinal product contains up to 151.27 mg (6.58 mmol) sodium per recommended dose.
Slovenian: Priporočeni odmerek rekonstituiranega zdravila vsebuje do 151,27 mg (6,58 mmol) natrija.
English: Potential leakage should be measured by radioactively labelled albumin or erythrocytes injected into the perfusion circuit, with appropriate measures for continuous monitoring of radioactivity leakage into the systemic circulation.
Slovenian: Morebitno uhajanje moramo nadzorovati z radioaktivno označenim albuminom ali eritrociti, ki jih vbrizgamo v perfuzijski krogotok, ob ustreznem neprekinjenem spremljanju uhajanja radioaktivnosti v sistemski obtok.
English: How to use Beromun
Slovenian: Kako uporabljati zdravilo Beromun
English: Each vial contains 1 mg tasonermin, corresponding to 3.0-6.0 x 107 IU.
Slovenian: Ena viala vsebuje 1 mg tasonermina, kar ustreza 3,0-6,0 x 107 i.e.
English: The solution has a clear to light yellow colour.
Slovenian: Raztopina je brezbarvna do svetlo rumena.
English: Altered renal function comprised increased water and sodium excretion as well as increased urea and creatinine.
Slovenian: Spremembe ledvične funkcije so se pokazale kot povečano izločanje vode in natrija ter porast uree in kreatinina.
English: In the Rhesus monkey, whole body radiography following administration of radiolabelled tasonermin indicated no specific distribution pattern.
Slovenian: Rhesus radiografija vsega telesa po dajanju radioaktivno označenega tasonermina ni pokazala specifičnega vzorca porazdelitve.
English: Further, adherence and extravasation of leukocytes is increased, leading to infiltration of the tumour by lymphocytes, monocytes, and granulocytes.
Slovenian: Poleg tega se povečata adherenca in ekstravazacija levkocitov, kar privede do infiltracije tumorja z limfociti, monociti in granulociti.
English: Each vial contains 1 mg tasonermin*, corresponding to 3.0-6.0 x 107 IU (International Units).
Slovenian: Ena viala vsebuje 1 mg tasonermina*, kar ustreza 3,0-6,0 x 107 i.e. (mednarodnih enot).
English: Proliferation of activated B- and T-lymphocytes, development of cytotoxic T-cells and immunoglobulin-secreting cells is enhanced, monocytes/macrophages are activated for killing of tumour cells, granulocytes are activated to display enhanced phagocytic activity, respiratory burst and degranulation, and adherence to endothelium.
Slovenian: Proliferacija aktiviranih limfocitov B in T, razvoj citotoksičnih celic T in celic, ki izločajo imunoglobulin, se poveča; monociti/makrofagi se aktivirajo za uničevanje tumorskih celic; granulociti se aktivirajo, tako da se poveča njihova fagocitna aktivnost, respiratorni izbruh in degranulacija ter sprijemanje na endotelij.
English: In the Rhesus monkey, pharmacokinetic studies following intravenous injection of tasonermin indicated a non-specific, non-saturable excretion via glomerular filtration in the kidney.
Slovenian: Pri opici Rhesus so farmakokinetične raziskave po intravenski injekciji tasonermina pokazale nespecifično, nesaturabilno izločanje z glomerulno filtracijo v ledvicah.
English: The systemic pharmacokinetic information on tasonermin is sparse.
Slovenian: Sistemska farmakokinetika Podatkov o sistemski farmakokinetiki tasonermina je malo.
English: A dose-dependency has been observed as indicated by a decrease in clearance and an increase in half-life at increasing doses.
Slovenian: Zasledili so odvisnost od velikosti odmerka, na kar sta pokazala zmanjšanje očistka in povečanje razpolovne dobe med povečevanjem odmerka.
English: Each vial contains 20.12 mg (0.87 mmol) sodium.
Slovenian: Ena viala vsebuje 20,12 mg (0,87 mmol) natrija.
English: In the event of severe shock before the end of the ILP, the limb perfusion should be discontinued and appropriate therapy administered.
Slovenian: Če pride pred koncem postopka do hudega šoka, moramo izolirano perfuzijo okončine prekiniti in uvesti ustrezno zdravljenje.
English: The addition of interferon-gamma to the tasonermin perfusate seems not to be associated with significant increases in endogenous production of tasonermin or other inflammatory cytokines as shown in patients with severe trauma.
Slovenian: Kaže, da dodatek interferona gama v perfuzijski raztopini tasonermina pomembneje ne poveča endogenega nastajanja tasonermina ali drugih vnetnih citokinov, kar se je pokazalo pri bolnikih s hudo travmo.
English: The haematological changes included anaemia, increased haematocrit and increased or decreased leukocytes and platelets depending upon species and treatment duration.
Slovenian: Hematološke spremembe so bile anemija, povečan hematokrit in porast ali zmanjšanje števila levkocitov in trombocitov glede na živalsko vrsto in trajanje dajanja.
English: Finally, your limb will be washed out to remove the rest of Beromun and melphalan.
Slovenian: Ob koncu postopka z izpiranjem iz okončine odstranijo preostalo količino zdravila Beromun in melfalana.
English: - The active substance is tasonermin.
Slovenian: - Zdravilna učinkovina je tasonermin.
English: After 30 minutes perfusion of Beromun alone, melphalan should be added as a bolus into the reservoir of the circuit, or slowly into the arterial line of the circuit.
Slovenian: Po 30 minutah perfuzije s samim zdravilom Beromun je treba dodati melfalan v obliki bolusa v rezervoar krogotoka ali počasi v arterijski vod obtoka.
English: Significant cardiovascular disease, e.g. congestive heart failure (New York Heart Association Class II, III or IV), severe angina pectoris, cardiac arrhythmias, myocardial infarction within a 3 months period prior to treatment, venous thrombosis, occlusive peripheral arterial disease, recent pulmonary embolism.
Slovenian: Hujša srčnožilna bolezen, npr. zastojno srčno popuščanje (II., III. ali IV. razred po klasifikaciji New York Heart Association), huda angina pektoris, srčne aritmije, miokardni infarkt v obdobju 3 mesecev pred posegom, venska tromboza, okluzivna periferna arterijska bolezen, nedavna pljučna embolija Hude motnje pljučne funkcije
English: Under conditions of greater than 2 % systemic leakage (observed in 13 of 51 patients) maximum systemic concentrations of tasonermin were still at least ten times lower than in the perfusion circuit.
Slovenian: Če je bilo uhajanje v sistemski obtok večje od 2 % (pri 13 od 51 bolnikov), je bila največja sistemska koncentracija tasonermina še vedno najmanj 10-krat manjša kot v perfuzijskem krogotoku.
English: Tasonermin did not cross the placenta or pass into necrotic tumour.
Slovenian: Tasonermin ni prehajal skozi posteljico niti v nekrotični tumor.
English: Venous thrombosis, arterial thrombosis, shock, hypotension
Slovenian: venska tromboza, arterijska tromboza, šok, hipotenzija občasni:
English: Perfusate samples of several ILPs showed plateau levels of tasonermin (as measured by ELISA) up to 100 minutes after start of perfusion, with no decay attributable to degradation.
Slovenian: Vzorci perfuzijske raztopine, zbrani pri različnih izoliranih perfuzijah okončin, so vsebovali platojsko raven tasonermina (izmerjeno s preizkusom ELISA) do 100 minut po začetku perfuzije, ne da bi prišlo do kvarjenja, ki bi ga lahko pripisali razgradnji.
English: Significant hepatic dysfunction, e.g. > 2 x upper limits of normal levels of aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase; or bilirubin levels > 1.25 x upper limits of normal.
Slovenian: Hujše motnje jetrnega delovanja, npr. > 2-kratna zgornja meja normalnih ravni aspartat-aminotransferaze, alanin-aminotransferaze ali alkalne fosfataze; ali raven bilirubina > 1,25-kratna zgornja meja normalne ravni
English: Colloids and hydroxyethyl starch fluids are preferred, as they are less likely to leak out of the vascular system.
Slovenian: Priporočamo uporabo koloidov in hidroksietil škroba, ker je pri njiju možnost uhajanja iz žilnega sistema manjša.
English: Direct effects on tumour vasculature: Tasonermin affects the morphology and reduces proliferation of endothelial cells and modifies expression of specific cell surface and secretory proteins (including adhesion molecules and proteins modulating coagulation, interleukins and haematopoietic growth factors).
Slovenian: Neposredni učinki na tumorjevo žilje: tasonermin deluje na celično morfologijo in zmanjša proliferacijo endotelijskih celic ter spremeni izražanje specifičnih beljakovin na površini celic in sekrecijskih beljakovin (vključno z adhezijskimi molekulami in beljakovinami, ki modulirajo strjevanje, interlevkini in hematopoetičnimi rastnimi faktorji).
English: Beromun contains the active substance tasonermin (tumor necrosis factor alfa-1a), produced by recombinant DNA technology.
Slovenian: Zdravilo Beromun vsebuje zdravilno učinkovino tasonermin (tumorski nekrotični faktor alfa-1a), izdelan s tehnologijo rekombinantne DNK.
English: No late detrimental effects of tasonermin were seen.
Slovenian: Tasonermin ni imel poznih škodljivih učinkov.
English: Doses of up to 6 mg of other TNFα preparations have been administered via ILP, but this dose was found to be unacceptable in terms of loco-regional toxicity.
Slovenian: Za izolirano perfuzijo okončine so že uporabili do 6-miligramske odmerke drugih pripravkov TNFα, vendar se je pokazalo, da so tako veliki odmerki zaradi lokalnoregionalne toksičnosti nesprejemljivi.
English: The most frequent adverse reactions reported in clinical trials were fever, nausea, vomiting, fatigue, arrhythmia, chills, pain, wound infection and skin reaction.
Slovenian: Najpogostejši neželeni učinki, o katerih so poročali v kliničnih preskušanjih, so bili povišana telesna temperatura, slabost, bruhanje, utrujenost, aritmija, mrzlica, bolečina, okužba rane in kožna reakcija.
English: For ILP, you will also receive other medicines to control pain, fever, blood pressure and blood clotting, as well as general anaesthesia.
Slovenian: Za izolirano perfuzijo okončine boste prejeli tudi druga zdravila, in sicer proti bolečinam in vročini ter za uravnavo krvnega tlaka in splošno anestezijo.
English: Hand and foot, if not affected, should be protected by Esmarch (expulsion) bandages.
Slovenian: Če roke in stopala niso prizadete, jih zaščitimo z Esmarchovimi prevezami.
English: Therefore, whenever there is significant systemic leakage of tasonermin, serious undesirable effects are to be expected.
Slovenian: Zato lahko večje uhajanje tasonermina v sistemski obtok povzroči resne neželene učinke.
English: Combinations with cardiotoxic substances (e.g. anthracyclines) should be avoided because it is possible that tasonermin could enhance cardiotoxicity, as has been observed in preclinical 13-week toxicological investigations.
Slovenian: Kombiniranemu dajanju s kardiotoksičnimi učinkovinami (npr. antraciklini) se je treba izogibati, ker lahko tasonermin poveča kardiotoksično delovanje, kar so ugotovili v predkliničnih 13-tedenskih toksikoloških raziskavah.
English: Hypersensitivity reaction
Slovenian: preobčutljivostna reakcija
English: Combinations with cardiotoxic substances (e.g. anthracyclines) should be avoided because it is possible that tasonermin could enhance cardiotoxicity, as has been observed in preclinical 13-week toxicological investigations (see section 4.4).
Slovenian: Hkratnemu dajanju s kardiotoksičnimi učinkovinami (npr. antraciklini) se je treba ogibati, ker lahko tasonermin poveča kardiotoksično delovanje, kar so ugotovili v predkliničnih 13-tedenskih toksikoloških raziskavah (glejte poglavje 4.4).
English: - if you are breast-feeding, you must stop for at least seven days after receiving Beromun
Slovenian: - če dojite, morate dojenje prekiniti najmanj sedem dni po zdravljenju z zdravilom Beromun.
English: Contraindications to Beromun ILP, subdivided by components of the procedure, are: Contraindications to Beromun:
Slovenian: Kontraindikacije za izolirano perfuzijo okončine z zdravilom Beromun, navedene po posameznih delih postopka, so: Kontraindikacije za zdravilo Beromun:
English: After connection of the limb to the isolated circuit, flow rate should be adjusted to 35 to 40 ml/litre limb volume/minute and leakage from limb to systemic circulation checked using a radioactive tracer technique (see section 4.4).
Slovenian: Ko priključimo okončino na izolirani krogotok, moramo hitrost pretoka naravnati na 35 do 40 ml/l volumna okončine/minuto in preveriti morebitno uhajanje zdravilne učinkovine iz okončine v sistemski obtok z radioaktivnim sledilcem (glejte poglavje 4.4).
English: The content of one vial of Beromun powder should be reconstituted with 5.3 ml sterile 0.9% sodium chloride solution for injection.
Slovenian: Vsebino ene viale zdravila Beromun prašek je treba rekonstituirati s 5,3 ml sterilne 0,9-odstotne raztopine natrijevega klorida za injiciranje.
English: After that, melphalan will be added and the ILP continued for another 60 minutes.
Slovenian: Nato dodajo melfalan in postopek izolirane perfuzije okončine nadaljujejo še 60 minut.
English: At the end of the perfusion, the perfusate should be collected into the reservoir while washout fluid is added simultaneously to the circuit and circulated at the same flow rate of 35 to 40 ml/litre limb volume/minute.
Slovenian: Ob koncu perfuzije zberemo perfuzijsko raztopino v rezervoar in hkrati dodamo v krogotok tekočino za izpiranje, ki naj kroži z enako hitrostjo, 35 do 40 ml/l volumna okončine/minuto.
English: Popliteal and brachial perfusions may not need more than 1 litre.
Slovenian: Za poplitealne in brahialne perfuzije navadno zadošča 1 liter.
English: Adverse reactions are either local, affecting the limb treated with ILP, or systemic.
Slovenian: Neželeni učinki so bodisi lokalni, ki vplivajo na okončino zdravljeno s postopkom izolirane perfuzije, ali sistemski.
English: A matched-pair survival analysis of patients treated by Beromun and melphalan ILP as compared to a historical control failed to demonstrate any survival difference (p=0.5).
Slovenian: Analiza usklajenih parov o preživetju bolnikov, ki so se zdravili z izolirano perfuzijo okončine z zdravilom Beromun in melfalanom, v primerjavi s kontrolno skupino iz preteklosti ni pokazala razlike pri preživetju (p = 0,5).
English: There is no specific antidote for tasonermin currently available.
Slovenian: Za tasonermin ni specifičnega protistrupa.
English: Pregnancy and lactation.
Slovenian: Nosečnost in dojenje
English: 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.
Slovenian: Z zmanjšanjem tumorja olajšamo njegovo kirurško odstranitev, preprečimo hude poškodbe okolnega zdravega tkiva ter odložimo amputacijo roke ali noge ali jo preprečimo.
English: Additional resuscitation fluids (crystalloid and colloid solutions) should be available for volume expansion in case of a significant fall in blood pressure.
Slovenian: Pripravljene moramo imeti tekočine za povečanje volumna (kristaloidne in koloidne raztopine), če pride do večjega znižanja krvnega tlaka.
English: Haematological disorders, in particular leukopaenia, thrombocytopaenia and clotting dysfunction, might be expected.
Slovenian: Možne so hematološke motnje, zlasti levkopenija, trombocitopenija in motnje strjevanja.