FrancophonIA/ELRC3.0 huggingface dataset:
English: Beromun must not be administered systemically.
Slovenian: Zdravilo Beromun ne smemo dajati sistemsko.
English: Volume expanders and vasopressors are recommended.
Slovenian: Priporočamo dajanje eskpanderjev volumna in vazopresorjev.
English: Blood, supplied with oxygen by a heart and lung machine, is pumped into your affected limb via a catheter in the main artery, while it is drained (pumped out) from the main vein.
Slovenian: Kri, ki v aparatu srce-pljuča sprejme kisik, črpalka črpa v prizadeto okončino skozi kateter v glavni arteriji, izteka pa (jo aparat izčrpa) skozi kateter v glavni veni.
English: Tasonermin has been shown to be active in the classic assay for tumour necrosis factor, producing haemorrhagic necrosis of tumour nodules in murine syngeneic and human xenogeneic tumour systems after local or systemic injection.
Slovenian: Pokazalo se je, da je tasonermin aktiven v klasičnem preizkusu tumorje nekrotizirajočega faktorja, pri katerem je po lokalnem ali sistemskem vbrizganju povzročil hemoragično nekrozo tumorskih vozličev v singenskih tumorskih sistemih glodalcev in humanih ksenogenskih tumorskih sistemih.
English: Further, in addition to its direct effects, tasonermin modulates immune responses by inducing production of cytokines as well as low molecular weight mediators (prostaglandins, platelet activating factor).
Slovenian: Tasonermin poleg neposrednih učinkov tudi modulira imunsko odzivanje, z indukcijo nastanka citokinov in nizkomolekularnih mediatorjev (prostaglandinov, trombocite aktivirajočega faktorja).
English: To cover the intended clinical use of Beromun, ILP experiments were performed in hind legs of healthy rats using different doses in the same tasonermin concentration as in the clinical situation in the human.
Slovenian: Da bi izvedli ustrezne raziskave glede na klinično uporabo zdravila Beromun, so izolirano perfuzijo okončin izvedli na zadnjih nogah pri zdravih podganah, za kar so uporabili različne odmerke z enako koncentracijo tasonermina, kot je predvidena v kliničnih razmerah za človeka.
English: Under conditions of less than 2% systemic leakage (observed in 38 of 51 patients), maximum systemic circulation concentrations of tasonermin were reached 5 min after the start of ILP and are approximately 200 times less than in the perfusion circuit.
Slovenian: Če je bilo sistemsko uhajanje manjše od 2 % (pri 38 od 51 bolnikov), so največjo koncentracijo tasonermina v sistemskem obtoku izmerili 5 minut po začetku izolirane perfuzije okončine, bila pa je približno 200-krat manjša kot v perfuzijskem krogotoku.
English: Description of selected adverse reactions
Slovenian: Opis izbranih neželinih učinkov
English: Therefore patients should be monitored during the first three days after the ILP.
Slovenian: Zato moramo prve tri dni po izolirani perfuziji okončine bolnikovo stanje spremljati.
English: Some of the side effects can be serious, particularly if Beromun reaches other parts of your body (systemic leakage).
Slovenian: Nekateri neželeni učinki so lahko resni, zlasti če zdravilo Beromun prehaja v druge telesne dele
English: Beromun is used, together with melphalan containing medicine, for the treatment of soft tissue sarcoma of the arms and legs.
Slovenian: Zdravilo Beromun uporabljamo, skupaj z zdravilom, ki vsebuje melfalan, za zdravljenje sarkoma mehkih tkiv rok in nog.
English: Data obtained from 51 ILP patients demonstrated maximum concentrations of tasonermin in the perfusion circuit are reached 30 min after the onset of ILP and range between 3000 and 4000 ng/ml.
Slovenian: Podatki, o katerih poročajo pri 51 bolnikih, pri katerih so izvedli izolirano perfuzijo okončine, kažejo, da je koncentracija tasonermina v perfuzijskem krogotoku največja 30 minut po začetku postopka, in da se giblje v območju od 3.000 do 4.000 ng/ml.
English: Symptoms of muscle damage at the perfused limb include pain, swelling, as well as neurological symptoms (e. g. paraesthesia, paralysis), all of which should be reported immediately to the attending doctor.
Slovenian: Simptomi poškodbe mišice v perfundirani okončini so bolečina, oteklina in nevrološki simptomi (npr. parestezija, paraliza) in je o njih treba takoj obvestiti lečečega zdravnika.
English: The terminal half-life at the maximum tolerated intravenous dose (150 µg/m2) was 15-30 min.
Slovenian: Končna razpolovna doba je bila 15 do 30 minut pri največjem intravenskem odmerku, ki so ga bolniki še lahko prenesli (150 μg/m2).
English: When necessary a second ILP can be considered 6-8 weeks after the first ILP (see section 4.4).
Slovenian: Če je potrebno, presodimo o ponovni izolirani perfuziji okončine, ki jo lahko izvedemo 6 do 8 tednov po prvi (glejte poglavje 4.4).
English: In such cases, a standard wash-out procedure should follow, using at least 2 litres of dextran 70 intravenous infusion or similar fluid.
Slovenian: V tem primeru moramo izvesti standardni postopek izpiranja, za katerega uporabimo najmanj 2 litra dekstrana 70 za intravensko infundiranje ali podobno tekočino.
English: In case the clinical diagnosis of compartment syndrome is made the following treatment should be considered: Fasciotomy of all muscle compartments of the limb affected, Forced diuresis and alkalinisation of the urine, if a muscle damage occurs with increased myoglobin levels in plasma and urine.
Slovenian: Pri klinični diagnozi utesnitvenega sindroma je treba presoditi o naslednjih terapevtskih ukrepih: - fasciotomiji (prerezanju mišičnih ovojnic) vseh mišičnih kompartmentov v prizadeti okončini; - forsirana diureza in alkalizacija seča, če so poškodovane mišice in povečane ravni mioglobina v plazmi in seču.
English: Adjustment of flow rate and tourniquet may be required to ensure leakage is stable (systemic level of radioactivity has reached a plateau) and does not exceed 10%.
Slovenian: Včasih moramo prilagajati hitrost pretoka in zažemko, da bi bilo uhajanje stabilno (da sistemska raven radioaktivnosti doseže plato) in ne bi prekoračilo 10 %.
English: Patients in whom the blood supply to the extremity distal to the tumour is suspected to be highly dependent on tumour associated blood vessels.
Slovenian: Bolniki, pri katerih obstaja sum, da je dotok krvi v okončino, distalno od tumorja, zelo odvisen od krvnih žil,
English: ), to a maximum dose of 150 mg. 13 mg/l perfused upper limb volume
Slovenian: ), do največjega odmerka, ki je 150 mg. 13 mg/l volumna perfundirane zgornje okončine 10 mg/l volumna perfundirane spodnje okončine
English: ILP allows the administration of high and fairly stable concentrations of tasonermin to the limb.
Slovenian: Izolirana perfuzija okončine omogoča uporabo velikih in precej stabilnih koncentracij tasonermina v okončini.
English: Should accidental overdose occur, ILP should be terminated immediately and the limb washed out using at least 2 litres of dextran 70 intravenous infusion or similar fluid (see also section 4.4).
Slovenian: Pri nenamernem vnosu prevelikega odmerka je treba izolirano perfuzijo takoj prekiniti in okončino izprati z najmanj 2 litroma dekstrana 70 za intravensko infundiranje ali s podobno tekočino (glejte tudi poglavje 4.4).
English: During the ILP, central venous pressure and arterial pressure monitoring is strongly recommended.
Slovenian: Med izolirano perfuzijo okončine je zelo priporočljivo spremljati centralni venski in arterijski tlak.
English: Adjustment of flow rate and tourniquet may be required to ensure leakage from perfusion circuit to systemic circulation is stable (systemic level of radioactivity has reached a plateau) and does not exceed 10 %.
Slovenian: Včasih je treba prilagoditi hitrost pretoka in zažemko, tako da je uhajanje iz perfuzijskega v sistemski obtok stabilno (da sistemska raven radioaktivnosti doseže plato) in ne prekorači 10 %.
English: ILP allows that tumour cells in your limb can be exposed to a very high dose of Beromun and melphalan, enhancing their anti-tumour effect, but without reaching the rest of the body, where they could cause serious side effects.
Slovenian: Med postopkom izolirane perfuzije okončine so tomorske celice v okončini izpostavljene zelo velikima odmerkoma zdravila Beromun in melfalana, kar poveča njun protitumorski učinek, ne da bi zdravili prehajali v druge telesne dele, kjer bi lahko imeli resne neželene učinke.
English: Undesirable effects may be related to Beromun, to melphalan, or to the ILP procedure and associated measures, or to a combination of these factors.
Slovenian: Neželene učinke lahko imajo zdravilo Beromun, melfalan, postopek izolirane perfuzije ali kombinacija teh dejavnikov.
English: At ILP, no incompatibilities with other constituents of the perfusate, with hyperthermia or with the membrane oxygenator and the silicone tubing are known.
Slovenian: Pri izolirani perfuziji okončine niso znane inkompatibilnosti z drugimi sestavinami perfuzijske raztopine, s hipertermijo ali z membranskim oksigenatorjem ali silikonskimi cevkami.
English: Peripheral arterial occlusive disease Respiratory, thoracic and mediastinal disorders Common:
Slovenian: periferna arterijska okluzivna bolezen Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti:
English: Direct inhibition of tumour cell proliferation: Tasonermin is cytotoxic or cytostatic in vitro for a variety of tumour cell lines of different histogenesis.
Slovenian: Neposredno zaviranje proliferacije tumorskih celic: tasonermin deluje in vitro citotoksično ali citostatično na različne tumorske celične linije različne histogeneze.
English: Prophylaxis and treatment of fever, chills and other influenza-like symptoms associated with Beromun administration can be achieved by pre-ILP administration of paracetamol (oral or by suppository) or an alternative analgesic/antipyretic.
Slovenian: Vročino, mrzlico in druge gripozne simptome, ki so povezani z dajanjem zdravila Beromun, lahko preprečimo s paracetamolom (peroralno ali v obliki svečk) ali drugim analgetikom oz. antipiretikom pred posegom.
English: You must not breast-feed for at least seven days after treatment with Beromun.
Slovenian: Po zdravljenju z zdravilom Beromun najmanj sedem dni ne smete dojiti.
English: Hepatotoxicity
Slovenian: hepatotoksičnost
English: A Swan-Ganz catheter may be considered for monitoring pulmonary artery pressure and wedge pressure during the ILP and in the post-operative period.
Slovenian: Presoditi je treba o uporabi Swan-Ganzovega katetra za spremljanje tlaka pljučne arterije in zagozditvenega tlaka med izolirano perfuzijo okončine in v pooperativnem obdobju.
English: Sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, human serum albumin
Slovenian: Natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat dodekahidrat, humani serumski albumin
English: The blood flow to and from your affected limb will be stopped using a tourniquet.
Slovenian: Pretok krvi v prizadeto okončino in iz nje bodo zaustavili z zažemko.
English: External heat loss from the limb should be prevented by application of thermal blankets and limb temperature continuously monitored by thermistor probes inserted into subcutaneous tissue and muscle.
Slovenian: Izgubo toplote na površini okončine preprečimo z ogrevalnimi odejami in neprekinjenim spremljanjem njene temperature s termistorskimi sondami, vstavljenimi v podkožno tkivo in mišice.
English: No evidence has been found of any mutagenic effect, neither in vivo nor in vitro.
Slovenian: Niti in vivo niti in vitro raziskave niso pokazale nikakršnih mutagenih učinkov.
English: Skin necrosis, oedema peripheral
Slovenian: kožne nekroze, periferni edem občasni:
English: The maximum tolerated dose (MTD) of tasonermin for ILP is 4 mg, which is 10 times the systemic MTD.
Slovenian: Največji odmerek tasonermina za izolirano perfuzijo okončine, ki ga bolniki še prenašajo, je 4 mg, kar je 10 -krat več kot največji, še prenosljivi sistemski odmerek.
English: Because of the unknown risk to the infant, breast-feeding is contraindicated within 7 days of ILP (see section 4.3).
Slovenian: Ker ne poznamo tveganosti uporabe zdravila za dojenčke, je dojenje 7 dni po izolirani perfuziji okončine kontraindicirano (glejte poglavje 4.3).
English: Each pack contains 4 vials of powder.
Slovenian: V enem pakiranju so 4 viale praška.
English: Onychomadesis (loss of nails) Musculoskeletal and connective tissue disorders Common:
Slovenian: onihomadeza (izguba nohtov) Bolezni mišično-skeletnega sistema in vezivnega tkiva pogosti:
English: The loco-regional application of Beromun, along with melphalan, has been shown to be highly effective for local control of irresectable soft tissue sarcomas of the limbs.
Slovenian: Lokalnoregionalna uporaba zdravila Beromun ob hkratni uporabi melfalana je pri lokalnem nadzoru neoperabilnih sarkomov mehkega tkiva okončin pokazala visoko učinkovitost.
English: A condition called “compartment syndrome” may develop within the first three days after Beromun administration.
Slovenian: Prve tri dni po dajanju zdravila Beromun se lahko razvije stanje, ki ga imenujemo “utesnitveni sindrom”.
English: Wash-out should continue until a clear (pink, transparent) venous outflow is obtained.
Slovenian: Izpiramo, dokler ne priteče čisti (rožnati, prozorni) venozni izliv.
English: You must not use Beromun if you are pregnant.
Slovenian: Če ste noseči, zdravila Beromun ne smete uporabiti.
English: Patients with contraindications to the use of anticoagulants.
Slovenian: Bolniki, pri katerih je kontraindicirana uporaba antikoagulansov
English: Skin and subcutaneous tissue disorders Very common:
Slovenian: Bolezni kože in podkožja zelo pogosti:
English: If signs of systemic toxicity appear, for example fever, cardiac arrhythmias, shock/hypotension, adult respiratory distress syndrome (ARDS), general supportive measures should be employed and the patient immediately transferred to an Intensive Care Unit for monitoring.
Slovenian: Če se pojavijo sistemski toksični znaki, na primer vročina, srčne aritmije, šok oz. hipotenzija ali sindrom dihalne stiske, je treba uvesti podporne ukrepe in bolnika takoj premestiti na oddelek za intenzivno zdravljenje na opazovanje.
English: Sepsis Blood and lymphatic system disorders Common:
Slovenian: Bolezni krvi in limfatičnega sistema pogosti:
English: Infection, wound infection
Slovenian: okužba, okužba rane občasni:
English: In addition, as the clinical situation dictates, a vasopressor agent, e.g. dopamine, can be considered for administration during the ILP procedure, as well as in the post-operative period.
Slovenian: Poleg tega lahko glede na klinično stanje presodimo tudi o uporabi vazopresornih učinkovin, npr. dopamina, ki ga dajemo med izolirano perfuzijo okončine ter v pooperativnem obdobju.
English: Late onset of peripheral arterial occlusive disease (PAOD) of the lower limbs has been reported in patients several years after ILP, predominantly in patients presenting with established cardiovascular risk factors, or who had undergone additional irradiation therapy of the concerned limb.
Slovenian: Več let po izolirani perfuziji okončine so poročali o poznem pojavu periferne arterijske okluzivne bolezni spodnjih okončin, pretežno pri bolnikih z znanimi dejavniki tveganja za bolezni srca in ožilja ali bolnikih, pri katerih so isto okončino dodatno zdravili z obsevanjem.
English: The container contains latex rubber
Slovenian: Vsebnik vsebuje naravno gumo (lateks)
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Beromun Vsebina pakiranja in dodatne informacije
English: Furthermore, blood pressure, urine output and electrocardiographic monitoring should be routinely undertaken in the first 24 to 48 hours post-ILP, or longer if indicated.
Slovenian: Poleg tega je prvih 24 do 48 ur po izolirani perfuziji okončine ali dlje, kadar je indicirano, treba rutinsko nadzirati krvni tlak, izločanje seča in bolnika elektrokardiografsko spremljati.
English: What Beromun looks like and contents of the pack
Slovenian: Izgled zdravila Beromun in vsebina pakiranja
English: Blood creatinine increased Surgical and medical procedures Common:
Slovenian: zvišanje kreatinina v krvi Kirurški in drugi medicinski posegi pogosti:
English: Tasonermin does not cross the intact blood-brain barrier to a significant extent in mice.
Slovenian: Tasonermin pri miših pomembneje ne prehaja skozi nepoškodovano krvno-možgansko pregrado.
English: Significant haematological dysfunction, e.g. leucocytes < 2.5 x 109/l, haemoglobin < 9 g/dl, platelets < 60 x 109/l, haemorrhagic diathesis or active bleeding disorder.
Slovenian: Hud ascites Hujše hematološke motnje, npr. levkociti < 2,5 x 109/l, hemoglobin < 9 g/dl, trombociti < 60 x 109/l,
English: 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).
Slovenian: Zdravilo Beromun je indicirano pri odraslih kot pomožni ukrep, ob poznejši kirurški odstranitvi tumorja, s katerim preprečimo ali odložimo amputacijo, ali pri paliativnem zdravljenju neoperabilnih sarkomov v mehkem tkivu okončin, v kombinaciji z melfalanom, z blago hipertermično izolirano perfuzijo okončine.
English: Beromun will be administered by a doctor who is experienced and skilled in isolated limb perfusion (ILP).
Slovenian: Zdravilo Beromun vam bo dajal izkušen zdravnik, ki je izurjen v uporabi tehnike izolirane perfuzije okončine.
English: Following the ILP, a standard wash-out procedure should always be employed, using dextran 70 intravenous infusion or similar fluid.
Slovenian: Po izolirani perfuziji okončine moramo vedno izvesti standardni postopek izpiranja z dekstranom 70 za intravensko infundiranje ali s podobno tekočino.
English: Upper limb: 3 mg total dose by ILP Lower limb: 4 mg total dose by ILP
Slovenian: Zgornja okončina: skupni odmerek po 3 mg z izolirano perfuzijo okončine Spodnja okončina: skupni odmerek po 4 mg z izolirano perfuzijo okončine
English: Powder for solution for infusion 4 vials of powder for solution for infusion
Slovenian: prašek za raztopino za infundiranje 4 viale praška za raztopino za infundiranje
English: If a second ILP is indicated, physicians should take into account the leakage rate of the previous ILP.
Slovenian: Če je indicirana ponovitev izolirane perfuzije okončine, mora zdravnik upoštevati stopnjo uhajanja zdravila v sistemski obtok med prvim postopkom.
English: Significant renal dysfunction, e.g. nephrotic syndrome, serum creatinine > 150 µmol/l, or creatinine clearance of < 50 ml/min.
Slovenian: hemoragična diateza ali aktivna krvavitev Hujše motnje ledvičnega delovanja, npr. nefrotični sindrom, serumski kreatinin > 150 µmol/l ali kreatininski očistek < 50 ml/min
English: Extremity necrosis and compartment syndrome might be severe enough to warrant amputation.
Slovenian: Nekroza okončine in utesnitveni sindrom, ki sta lahko tako huda, da je zaradi njiju potrebna amputacija.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Slovenian: 24 ur in 2 do 8 ºC, razen kadar raztopino pripravite v nadzorovanih in validiranih aseptičnih razmerah.
English: Beromun has been co-administered with interferon-gamma in the ILP setting but no added value has been demonstrated.
Slovenian: Zdravilo Beromun so v sklopu izolirane perfuzije okončine že dajali sočasno z interferonom gama, toda pokazalo se je, da ne prinaša dodatne koristi.
English: The systemic application of tasonermin is limited by its toxic effects, the effective dose predicted from preclinical studies being substantially higher than the observed human maximum tolerated dose.
Slovenian: Učinkovit odmerek, potreben glede na izsledke predkliničnih raziskav, je znatno večji kot največji odmerek, ki ga človek še prenese.
English: The resulting solution will be administered into an artery in your affected arm or leg by ILP for an initial period of 30 minutes.
Slovenian: Raztopino vnesejo v arterijo prizadete roke ali noge s postopkom izolirane perfuzije okončine za 30 minut.
English: Artificial respiratory support may be required if ARDS develops.
Slovenian: Če se razvije sindrom dihalne stiske, lahko bolnik potrebuje umetno predihavanje.
English: Fever, chills, pain, fatigue
Slovenian: vročina, mrzlica, bolečina, utrujenost pogosti:
English: If you get any side effects , talk to your doctor.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom.
English: Pulmonary oedema
Slovenian: pljučni edem
English: Contraindications to the ILP procedure:
Slovenian: Kontraindikacije za postopek izolirane perfuzije okončine:
English: Beromun is a white to off-white powder for solution for infusion (powder for infusion) supplied in a glass vial with rubber stopper and sealed with aluminium flip-off cap.
Slovenian: Zdravilo Beromun je bel do skoraj bel prašek za raztopino za infundiranje (prašek za infuzijo), pakiran v stekleno vialo z gumijastim zamaškom in tesnilno aluminijasto zaporko.
English: Concurrent administration of agents likely to cause significant hypotension is not recommended (see section 4.5).
Slovenian: Sočasnega dajanja zdravil, ki lahko povzročijo večjo hipotenzijo, ne priporočamo (glejte poglavje 4.5).
English: Melphalan dose should be calculated according to the litre-volume method of Wieberdink (Wieberdink J, Benckhuysen C, Braat RP, van Slooten EA, Olthius GAA.
Slovenian: Odmerek melfalana je treba izračunati po Wieberdinkovi litrsko-volumski metodi (Wieberdink J,
English: Clinical data however indicate that the overall incidence of adverse events is increased if patients are simultaneously exposed to tasonermin and interferon-gamma.
Slovenian: Vendar klinični podatki kažejo, da se pri bolnikih, ki hkrati prejemajo tasonermin in interferon gama, poveča pogostnost neželenih učinkov.
English: When necessary a second ILP can be considered 6-8 weeks after the first ILP.
Slovenian: Če je potrebno, presodimo o ponovni izolirani perfuziji okončine, ki jo lahko izvedemo 6 do 8 tednov po prvi.
English: Beromun contains sodium
Slovenian: Zdravilo Beromun vsebuje natrij
English: Concurrent administration of agents likely to cause significant hypotension is not recommended (see section 4.4).
Slovenian: Sočasnega dajanja zdravil, ki lahko povzročijo večjo hipotenzijo, ne priporočamo (glejte poglavje 4.4).
English: Cardiac disorders Very common:
Slovenian: Srčne bolezni zelo pogosti:
English: Powder vial Type I glass vial with chlorobutyl rubber stopper and sealed with aluminium flip-off cap.
Slovenian: Viala s praškom Viala iz stekla tipa I z gumijastim zamaškom iz klorobutila in tesnilno aluminijasto zaporko.
English: Severe ascites.
Slovenian: Hud ascites
English: 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.
Slovenian: Zdravljenje lahko izvajajo le specializirani centri s kirurškimi ekipami, ki imajo izkušnje z zdravljenjem sarkomov okončin in s postopkom izolirane perfuzije okončin, in ki ima jo oddelek za intenzivno nego in opremo za neprekinjeno spremljanje uhajanja zdravila v sistemski obtok.
English: Except for slight aggravation of ischaemic effects in higher doses, standard histological examinations of the skin, muscle, bone, nerves and vessels revealed no difference in findings between tasonermin-treated and control animals.
Slovenian: Standardne histološke preiskave kože, mišic, kosti, živcev in žil razen blagega povečanja ishemije po večjih odmerkih niso pokazale razlik med izvidi pri živalih, ki so prejele tasonermin, in izvidi pri kontrolnih živalih.
English: Beromun will be administered by isolated limb perfusion (ILP), together with the anti-tumour agent melphalan.
Slovenian: Zdravilo Beromun boste prejeli s tehniko izolirane perfuzije okončine, hkrati s protitumorskih zdravilom melfalanom.