natgillin/translations-raw huggingface dataset:
- 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.
- 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,
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.
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.
Upon reconstitution the product should be used immediately.
Po pripravi je treba zdravilo uporabiti takoj.
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.
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.
The reconstituted medicinal product contains up to 151.27 mg (6.58 mmol) sodium per recommended dose.
Priporočeni odmerek rekonstituiranega zdravila vsebuje do 151,27 mg (6,58 mmol) natrija.
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.
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.
How to use Beromun
Kako uporabljati zdravilo Beromun
Each vial contains 1 mg tasonermin, corresponding to 3.0-6.0 x 107 IU.
Ena viala vsebuje 1 mg tasonermina, kar ustreza 3,0-6,0 x 107 i.e.
The solution has a clear to light yellow colour.
Raztopina je brezbarvna do svetlo rumena.
Altered renal function comprised increased water and sodium excretion as well as increased urea and creatinine.
Spremembe ledvične funkcije so se pokazale kot povečano izločanje vode in natrija ter porast uree in kreatinina.
In the Rhesus monkey, whole body radiography following administration of radiolabelled tasonermin indicated no specific distribution pattern.
Rhesus radiografija vsega telesa po dajanju radioaktivno označenega tasonermina ni pokazala specifičnega vzorca porazdelitve.
Further, adherence and extravasation of leukocytes is increased, leading to infiltration of the tumour by lymphocytes, monocytes, and granulocytes.
Poleg tega se povečata adherenca in ekstravazacija levkocitov, kar privede do infiltracije tumorja z limfociti, monociti in granulociti.
Each vial contains 1 mg tasonermin*, corresponding to 3.0-6.0 x 107 IU (International Units).
Ena viala vsebuje 1 mg tasonermina*, kar ustreza 3,0-6,0 x 107 i.e. (mednarodnih enot).
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.
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.
In the Rhesus monkey, pharmacokinetic studies following intravenous injection of tasonermin indicated a non-specific, non-saturable excretion via glomerular filtration in the kidney.
Pri opici Rhesus so farmakokinetične raziskave po intravenski injekciji tasonermina pokazale nespecifično, nesaturabilno izločanje z glomerulno filtracijo v ledvicah.
The systemic pharmacokinetic information on tasonermin is sparse.
Sistemska farmakokinetika Podatkov o sistemski farmakokinetiki tasonermina je malo.
A dose-dependency has been observed as indicated by a decrease in clearance and an increase in half-life at increasing doses.
Zasledili so odvisnost od velikosti odmerka, na kar sta pokazala zmanjšanje očistka in povečanje razpolovne dobe med povečevanjem odmerka.
Each vial contains 20.12 mg (0.87 mmol) sodium.
Ena viala vsebuje 20,12 mg (0,87 mmol) natrija.
In the event of severe shock before the end of the ILP, the limb perfusion should be discontinued and appropriate therapy administered.
Če pride pred koncem postopka do hudega šoka, moramo izolirano perfuzijo okončine prekiniti in uvesti ustrezno zdravljenje.
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.
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.
The haematological changes included anaemia, increased haematocrit and increased or decreased leukocytes and platelets depending upon species and treatment duration.
Hematološke spremembe so bile anemija, povečan hematokrit in porast ali zmanjšanje števila levkocitov in trombocitov glede na živalsko vrsto in trajanje dajanja.
Finally, your limb will be washed out to remove the rest of Beromun and melphalan.
Ob koncu postopka z izpiranjem iz okončine odstranijo preostalo količino zdravila Beromun in melfalana.
- The active substance is tasonermin.
- Zdravilna učinkovina je tasonermin.
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.
Po 30 minutah perfuzije s samim zdravilom Beromun je treba dodati melfalan v obliki bolusa v rezervoar krogotoka ali počasi v arterijski vod obtoka.
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.
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
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.
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.
Tasonermin did not cross the placenta or pass into necrotic tumour.
Tasonermin ni prehajal skozi posteljico niti v nekrotični tumor.
Venous thrombosis, arterial thrombosis, shock, hypotension
venska tromboza, arterijska tromboza, šok, hipotenzija občasni:
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.
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.
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.
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
Colloids and hydroxyethyl starch fluids are preferred, as they are less likely to leak out of the vascular system.
Priporočamo uporabo koloidov in hidroksietil škroba, ker je pri njiju možnost uhajanja iz žilnega sistema manjša.
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).
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).
Beromun contains the active substance tasonermin (tumor necrosis factor alfa-1a), produced by recombinant DNA technology.
Zdravilo Beromun vsebuje zdravilno učinkovino tasonermin (tumorski nekrotični faktor alfa-1a), izdelan s tehnologijo rekombinantne DNK.
No late detrimental effects of tasonermin were seen.
Tasonermin ni imel poznih škodljivih učinkov.
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.
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.
The most frequent adverse reactions reported in clinical trials were fever, nausea, vomiting, fatigue, arrhythmia, chills, pain, wound infection and skin reaction.
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.
For ILP, you will also receive other medicines to control pain, fever, blood pressure and blood clotting, as well as general anaesthesia.
Za izolirano perfuzijo okončine boste prejeli tudi druga zdravila, in sicer proti bolečinam in vročini ter za uravnavo krvnega tlaka in splošno anestezijo.
Hand and foot, if not affected, should be protected by Esmarch (expulsion) bandages.
Če roke in stopala niso prizadete, jih zaščitimo z Esmarchovimi prevezami.
Therefore, whenever there is significant systemic leakage of tasonermin, serious undesirable effects are to be expected.
Zato lahko večje uhajanje tasonermina v sistemski obtok povzroči resne neželene učinke.
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.
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.
Hypersensitivity reaction
preobčutljivostna reakcija
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).
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).
- if you are breast-feeding, you must stop for at least seven days after receiving Beromun
- če dojite, morate dojenje prekiniti najmanj sedem dni po zdravljenju z zdravilom Beromun.
Contraindications to Beromun ILP, subdivided by components of the procedure, are: Contraindications to Beromun:
Kontraindikacije za izolirano perfuzijo okončine z zdravilom Beromun, navedene po posameznih delih postopka, so: Kontraindikacije za zdravilo Beromun:
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).
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).
The content of one vial of Beromun powder should be reconstituted with 5.3 ml sterile 0.9% sodium chloride solution for injection.
Vsebino ene viale zdravila Beromun prašek je treba rekonstituirati s 5,3 ml sterilne 0,9-odstotne raztopine natrijevega klorida za injiciranje.
After that, melphalan will be added and the ILP continued for another 60 minutes.
Nato dodajo melfalan in postopek izolirane perfuzije okončine nadaljujejo še 60 minut.
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.
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.
Popliteal and brachial perfusions may not need more than 1 litre.
Za poplitealne in brahialne perfuzije navadno zadošča 1 liter.
Adverse reactions are either local, affecting the limb treated with ILP, or systemic.
Neželeni učinki so bodisi lokalni, ki vplivajo na okončino zdravljeno s postopkom izolirane perfuzije, ali sistemski.
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).
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).
There is no specific antidote for tasonermin currently available.
Za tasonermin ni specifičnega protistrupa.
Pregnancy and lactation.
Nosečnost in dojenje
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.
Z zmanjšanjem tumorja olajšamo njegovo kirurško odstranitev, preprečimo hude poškodbe okolnega zdravega tkiva ter odložimo amputacijo roke ali noge ali jo preprečimo.
Additional resuscitation fluids (crystalloid and colloid solutions) should be available for volume expansion in case of a significant fall in blood pressure.
Pripravljene moramo imeti tekočine za povečanje volumna (kristaloidne in koloidne raztopine), če pride do večjega znižanja krvnega tlaka.
Haematological disorders, in particular leukopaenia, thrombocytopaenia and clotting dysfunction, might be expected.
Možne so hematološke motnje, zlasti levkopenija, trombocitopenija in motnje strjevanja.
Beromun must not be administered systemically.
Zdravilo Beromun ne smemo dajati sistemsko.
Volume expanders and vasopressors are recommended.
Priporočamo dajanje eskpanderjev volumna in vazopresorjev.
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.
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.
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.
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.
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).
Tasonermin poleg neposrednih učinkov tudi modulira imunsko odzivanje, z indukcijo nastanka citokinov in nizkomolekularnih mediatorjev (prostaglandinov, trombocite aktivirajočega faktorja).
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.
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.
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.
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.
Description of selected adverse reactions
Opis izbranih neželinih učinkov
Therefore patients should be monitored during the first three days after the ILP.
Zato moramo prve tri dni po izolirani perfuziji okončine bolnikovo stanje spremljati.
Some of the side effects can be serious, particularly if Beromun reaches other parts of your body (systemic leakage).
Nekateri neželeni učinki so lahko resni, zlasti če zdravilo Beromun prehaja v druge telesne dele
Beromun is used, together with melphalan containing medicine, for the treatment of soft tissue sarcoma of the arms and legs.
Zdravilo Beromun uporabljamo, skupaj z zdravilom, ki vsebuje melfalan, za zdravljenje sarkoma mehkih tkiv rok in nog.
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.
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.
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.
Simptomi poškodbe mišice v perfundirani okončini so bolečina, oteklina in nevrološki simptomi (npr. parestezija, paraliza) in je o njih treba takoj obvestiti lečečega zdravnika.
The terminal half-life at the maximum tolerated intravenous dose (150 µg/m2) was 15-30 min.
Končna razpolovna doba je bila 15 do 30 minut pri največjem intravenskem odmerku, ki so ga bolniki še lahko prenesli (150 μg/m2).
When necessary a second ILP can be considered 6-8 weeks after the first ILP (see section 4.4).
Če je potrebno, presodimo o ponovni izolirani perfuziji okončine, ki jo lahko izvedemo 6 do 8 tednov po prvi (glejte poglavje 4.4).
In such cases, a standard wash-out procedure should follow, using at least 2 litres of dextran 70 intravenous infusion or similar fluid.
V tem primeru moramo izvesti standardni postopek izpiranja, za katerega uporabimo najmanj 2 litra dekstrana 70 za intravensko infundiranje ali podobno tekočino.
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.
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.
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%.
Včasih moramo prilagajati hitrost pretoka in zažemko, da bi bilo uhajanje stabilno (da sistemska raven radioaktivnosti doseže plato) in ne bi prekoračilo 10 %.
Patients in whom the blood supply to the extremity distal to the tumour is suspected to be highly dependent on tumour associated blood vessels.
Bolniki, pri katerih obstaja sum, da je dotok krvi v okončino, distalno od tumorja, zelo odvisen od krvnih žil,
), to a maximum dose of 150 mg. 13 mg/l perfused upper limb volume
), do največjega odmerka, ki je 150 mg. 13 mg/l volumna perfundirane zgornje okončine 10 mg/l volumna perfundirane spodnje okončine
ILP allows the administration of high and fairly stable concentrations of tasonermin to the limb.
Izolirana perfuzija okončine omogoča uporabo velikih in precej stabilnih koncentracij tasonermina v okončini.
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).
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).
During the ILP, central venous pressure and arterial pressure monitoring is strongly recommended.
Med izolirano perfuzijo okončine je zelo priporočljivo spremljati centralni venski in arterijski tlak.
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 %.
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 %.