FrancophonIA/ELRC3.0 huggingface dataset:
English: Mechanism of action In vivo antitumour activity is probably based on direct and indirect effects:
Croatian: Mehanizam djelovanja In vivo antitumorska aktivnost se vjerojatno temelji na direktnim i indirektnim učincima:
English: The temperature should then be increased to >39°C (but not exceeding 40°C) in two different sites of measurement in the tumour area.
Croatian: Temperatura se zatim povećava na >39°C (ali ne preko 40°C) na dva različita mjesta mjerenja u području tumora.
English: Animal studies are insufficient with respect to effects on pregnancy, embryonal development and postnatal development (see section 5.3).
Croatian: Ispitivanja na životinjama su nedostatna s obzirom na učinke na trudnoću, embrionalni razvoj i postnatalni razvoj (vidjeti dio 5.3).
English: Popliteal and brachial perfusions may not need more than 1 litre.
Croatian: Za poplitealne i brahijalne perfuzije nije potrebno više od 1 litre.
English: In particular, you should tell your doctor if you are using medicines to lower blood pressure (to treat hypertension).
Croatian: Osobito je važno obavijestiti liječnika ako uzimate lijekove za snižavanje krvnog tlaka (za liječenje hipertenzije).
English: For any information about this medicine, please contact the Marketing Authorisation Holder:
Croatian: Za bilo kakve informacije u svezi s ovim lijekom, kontaktirajte Nositelja odobrenja za stavljanje lijeka u promet:
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.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja prije primjene su odgovornost korisnika te obično ne smiju biti dulji od 24 sata na 2 do 8°C, osim ako je rekonstitucija provedena u kontroliranim i validiranim aseptičkim uvjetima.
English: Beromun must not be administered systemically.
Croatian: Beromun se ne smije primjenjivati sistemski.
English: However, the treatment is specifically a loco-regional treatment and is not expected to influence survival.
Croatian: Međutim, liječenje je specifično lokoregionalno te se ne očekuje njegov utjecaj na preživljenje.
English: No evidence has been found of any mutagenic effect, neither in vivo nor in vitro.
Croatian: Nisu pronađeni dokazi mutagenih učinaka in vivo ni in vitro.
English: Systemic adverse reactions include mild constitutional reactions and toxic effects on different organ systems.
Croatian: Sistemske nuspojave uključuju blage konstitucijske reakcije i toksične učinke na različite organske sustave.
English: It is important that it does not reach other parts of your body, because this so-called systemic leakage could cause serious side effects on the main organs of the body.
Croatian: Važno je da ne dođe u druge dijelove tijela, jer takozvano sistemsko propuštanje može izazvati ozbiljne nuspojave na glavnim organima u tijelu.
English: Date of first authorisation: 13 April 1999 Date of latest renewal: 25 March 2009
Croatian: Datum posljednje obnove odobrenja: 25. ožujka 2009.
English: Pharmacotherapeutic group: Other immunostimulants, ATC code: L03AX11
Croatian: Farmakoterapijska skupina: drugi imunostimulansi, ATK oznaka: L03AX11
English: 2, Rue Albert 1er L-1117 Luxembourg Grand Duchy of Luxembourg Tel : +352 27403070
Croatian: 2, Rue Albert 1er L-1117 Luksemburg Veliko vojvodstvo Luksemburg Tel : +352 27403070
English: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000
Croatian: (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000).
English: If there is significant systemic leakage of Beromun
Croatian: U slučaju značajnog sistemskog propuštanja Beromuna
English: Nerve injury, peripheral neurotoxicity, altered state of consciouness, headache
Croatian: Ozljeda živca, periferna neurotoksičnost, promijenjeno stanje svijesti, glavobolja
English: Reconstituted solution Chemical and physical in-use stability has been demonstrated for up to 48 hours at 25°C.
Croatian: Rekonstituirana otopina Dokazana je kemijska i fizikalna stabilnost tijekom primjene do 48 sati na 25°C.
English: Hypercalcaemia > 12 mg/dl (2.99 mmol/l).
Croatian: Hiperkalcemija > 12 mg/dl (2,99 mmol/l).
English: The terminal half-life at the maximum tolerated intravenous dose (150 µg/m2) was 15-30 min.
Croatian: Poluvijek pri maksimalnoj intravenskoj podnošljivoj dozi (150 µg/m2) bio je 15-30 min.
English: If more than 10% of your Beromun dose reaches the main part of your body, your doctor will take similar measures as in the case of overdose.
Croatian: Ako više od 10 % doze Beromuna dođe do nekog od glavnih organa u tijelu, liječnik će poduzeti mjere slične onima kod predoziranja.
English: For instructions on administration, see section 4.2.
Croatian: Za upute o primjeni, vidjeti dio 4.2.
English: Severe pulmonary dysfunction.
Croatian: Teška plućna disfunkcija.
English: For the prophylaxis of shock, patients should always be maximally hydrated prior to, during and after the perfusion procedure.
Croatian: U svrhu sprječavanja šoka bolesnici moraju biti maksimalno hidrirani prije, tijekom i nakon postupka perfuzije.
English: Induction of general anaesthesia and subsequent mechanical ventilation should be applied according to standard methods.
Croatian: Indukcija opće anestezije i daljnja mehanička ventilacija se primjenjuju prema standardnim metodama.
English: It belongs to a class of medicines known as immunostimulants, which help your body's immune system fight cancer cells.
Croatian: Pripada skupini lijekova poznatih kao imunostimulansi koji pomažu Vašem imunološkom sustavu u borbi protiv stanica raka.
English: - The active substance is tasonermin.
Croatian: - Djelatna tvar je tasonermin.
English: The perfusion should be terminated if the cumulative leakage into the systemic circulation is > 10%.
Croatian: Perfuzija se prekida ako je kumulativno propuštanje u sistemsku cirkulaciju > 10 %.
English: 2, Rue Albert 1er L-1117 Luxembourg Grand Duchy of Luxembourg
Croatian: 2, Rue Albert 1er L-1117 Luksemburg Veliko vojvodstvo Luksemburg
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.
Croatian: Važno je održavati stalnu razinu anestezije u cilju sprječavanja velikih fluktuacija u sistemskom krvnom tlaku koje bi mogle utjecati na propuštanje između sistemske cirkulacije i perfuzijskog kruga.
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.
Croatian: Dozu melfalana potrebno je izračunati prema Wieberdinkovoj metodi litra-volumen (Wieberdink J, Benckhuysen C, Braat RP, van Slooten EA, Olthius GAA.
English: Simultaneous treatment with cardiotoxic substances (e.g. anthracyclines).
Croatian: Istovremeno liječenje kardiotoksičnim tvarima (npr. antraciklini).
English: Fertility No data on the possible effect of this medicinal product on male and female fertility are available.
Croatian: Nisu dostupni podaci o mogućem učinku ovog lijeka na mušku i žensku plodnost.
English: The circulatory changes included decreased blood pressure and, in some studies, increased heart rate and decreased contractility.
Croatian: Cirkulacijske promjene uključivale su sniženi krvni tlak i, u nekim ispitivanjima, povećanu srčanu frekvenciju i smanjenu kontraktilnost.
English: Further, animals that reject experimental tumours following tasonermin treatment may develop specific immunity for this tumour cell type.
Croatian: Nadalje, životinje kod kojih se eksperimentalni tumori ne prihvate nakon liječenja tasonerminom mogu razviti specifični imunitet za tu vrstu tumorskih stanica.
English: You must not breast-feed for at least seven days after treatment with Beromun.
Croatian: Ne smijete dojiti najmanje sedam dana nakon liječenja Beromunom.
English: From a microbiological point of view, the reconstituted product should be used immediately.
Croatian: S mikrobiološkog stajališta, rekonstituirani lijek se mora odmah primijeniti.
English: Therefore, whenever there is significant systemic leakage of tasonermin, serious undesirable effects are to be expected.
Croatian: Stoga, kada god postoji značajno sistemsko propuštanje tasonermina, očekuju se ozbiljne nuspojave.
English: Some of the side effects can be serious, particularly if Beromun reaches other parts of your body (systemic leakage).
Croatian: Neke od nuspojava mogu biti teške, osobito ako Beromun dosegne druge dijelove tijela (sistemsko propuštanje).
English: Contents of the pack and other information What Beromun contains
Croatian: Sadržaj pakiranja i druge informacije Što Beromun sadrži
English: Melphalan:
Croatian: Melfalan:
English: Clinical data however indicate that the overall incidence of adverse events is increased if patients are simultaneously exposed to tasonermin and interferon-gamma.
Croatian: Međutim, klinički podaci pokazuju da je ukupna incidencija štetnih događaja povećana ako se bolesnici istovremeno izlažu tasonerminu i interferonu gama.
English: Once opened, the content of a vial should normally be used immediately (see section 6.3).
Croatian: Nakon otvaranja, sadržaj bočice se mora odmah primijeniti (vidjeti dio 6.3).
English: Other medicines and Beromun
Croatian: Drugi lijekovi i Beromun
English: *tumor necrosis factor alfa-1a (TNFα-1a) produced by recombinant DNA technology in E. coli.
Croatian: *Čimbenik nekroze tumora alfa-1a (TNFα-1a) koji se proizvodi tehnologijom rekombinantne DNA u E. coli.
English: Beromun should only be administered if leakage is less than 10 %.
Croatian: Beromun se treba primjenjivati samo ako je propuštanje lijeka manje od 10 %.
English: Finally, your limb will be washed out to remove the rest of Beromun and melphalan.
Croatian: Konačno, ud se ispire radi uklanjanja ostataka Beromuna i melfalana.
English: As Beromun is always administered by experienced and qualified hospital doctors, accidental overdose is extremely unlikely.
Croatian: S obzirom da Beromun uvijek primjenjuju iskusni i kvalificirani bolnički liječnici, slučajno predoziranje je vrlo malo vjerojatno.
English: Venous thrombosis, arterial thrombosis, shock, hypotension
Croatian: Venska tromboza, arterijska tromboza, šok, hipotenzija
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.
Croatian: Ako postoji rizik od ozbiljnih nuspojava, liječnik će Vas odmah premjestiti u jedinicu intenzivnog liječenja radi pomnog praćenja i početka odgovarajućeg liječenja.
English: The reason for the differential sensitivity of the tumour vasculature (high) versus normal vasculature (low) are currently unknown.
Croatian: Razlog za različitu osjetljivost krvnih žila tumora (visoka) u odnosu na normalne krvne žile (niska) nije trenutno poznat.
English: A recent history of, or active peptic ulcer.
Croatian: Nedavno liječen ili aktivni peptički ulkus.
English: Indirect and direct immunomodulation: Tasonermin has profound effects on cellular components of the immune system.
Croatian: Indirektna i direktna imunomodulacija: Tasonermin ima dubinske učinke na stanične komponente imunološkog sustava.
English: Thus, the duration of the total perfusion should be 90 minutes.
Croatian: Odnosno, ukupna perfuzija treba trajati 90 minuta.
English: There are no adequate data from the use of tasonermin in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni tasonermina u trudnica.
English: After reconstitution in 0.9 % physiological sodium chloride solution the amount is 37.82 mg (1.64 mmol) sodium.
Croatian: Nakon rekonstitucije u 0,9%-tnoj fiziološkoj otopini natrijevog klorida, količina natrija je 37,82 mg (1,64 mmol).
English: The container of this medicinal product contains latex rubber.
Croatian: Spremnik ovog lijeka sadrži lateks.
English: Severe ascites.
Croatian: Obilni ascites.
English: This technique ensures that Beromun is kept within the affected arm or leg.
Croatian: Ova tehnika osigurava zadržavanje Beromuna unutar bolesne ruke ili noge.
English: The formulation does not contain a preservative and is for single use only.
Croatian: Pripravak ne sadrži konzervans te je namijenjen isključivo za jednokratnu primjenu.
English: No late detrimental effects of tasonermin were seen.
Croatian: Nisu primijećeni kasni štetni učinci tasonermina.
English: The reconstituted medicinal product contains up to 151.27 mg (6.58 mmol) sodium per recommended dose.
Croatian: Ovaj rekonstituirani lijek sadrži do 151,27 mg (6,58 mmol) natrija po preporučenoj dozi.
English: The toxicological profile of tasonermin has been investigated in preclinical studies using mice, rats, rabbits, dogs and monkeys.
Croatian: Toksikološki profil tasonermina je ispitivan u pretkliničkim ispitivanjima na miševima, štakorima, kunićima, psima i majmunima.
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.
Croatian: U cilju minimaliziranja rizika od propuštanja perfuzata u sistemsku cirkulaciju, brzina protoka perfuzije ne smije prelaziti 40 ml/litri volumena uda/minuti.
English: These changes in turn lead to a procoagulant state, resulting in microvascular thrombosis.
Croatian: Ove promjene vode do prokoagulantnog stanja rezultirajući mikrovaskularnom trombozom.
English: Additional resuscitation fluids (crystalloid and colloid solutions) should be available for volume expansion in case of a significant fall in blood pressure.
Croatian: (kristaloidne i koloidne otopine) moraju biti dostupne za ekspanziju volumena u slučaju značajnog pada krvnog tlaka.
English: Once the temperature in the distal subcutaneous tissue of the limb has reached >38°C, (but not exceeding 39°C), and pH of the perfusate is between 7.2 and 7.35, Beromun should be injected as a bolus into the arterial line of the circuit.
Croatian: Kada temperatura u distalnom potkožnom tkivu uda dosegne >38°C (ali ne preko 39°C), a pH perfuzata je između 7,2 i 7,35, Beromun se injicira u obliku bolusa u arterijski dio kruga.
English: What Beromun looks like and contents of the pack
Croatian: Kako Beromun izgleda i sadržaj pakiranja
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.
Croatian: Uzorci perfuzata nekoliko izoliranih perfuzija ekstremiteta pokazali su plato vrijednosti tasonermina (mjereno ELISAom) do 100 minuta nakon početka perfuzije, bez propadanja koje se pripisuje razgradnji.
English: Beromun is contraindicated in pregnancy (see section 4.3).
Croatian: Beromun je kontraindiciran u trudnoći (vidjeti dio 4.3).
English: Skin necrosis, oedema peripheral
Croatian: Nekroza kože, periferni edem
English: The following side effects were observed during treatment with this medicine (grouped by how likely they are to happen).
Croatian: Tijekom liječenja ovim lijekom bile su opažene sljedeće nuspojave (svrstane u skupine prema vjerojatnosti njihova nastanka).
English: Compartment syndrome, myalgia
Croatian: Kompartment sindrom, mialgija
English: - if you are allergic to tasonermin or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na tasonermin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) - ako imate značajne probleme sa srcem
English: Systemic pharmacokinetics
Croatian: Sistemska farmakokinetika
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.
Croatian: Osim laganog pogoršanja ishemijskih učinaka pri višim dozama, standardne histološke analize kože, mišića, kosti, živaca i žila nisu pokazale razliku u nalazima između životinja liječenih tasonerminom i kontrolnih životinja.
English: A second specific and saturable elimination mechanism involving tasonermin receptors seems likely.
Croatian: No, smatra se da vjerojatno postoji i drugi specifični, saturabilni mehanizam eliminacije koji uključuje tasonerminske receptore.
English: There is no specific antidote for tasonermin currently available.
Croatian: Ne postoji specifičan, trenutno dostupan, antidot za tasonermin.
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.
Croatian: Nekoliko razina dokaza pokazuje utjecaj ovih imunomodulatornih aktivnosti na antitumorske učinke, npr. antitumorski učinci tasonermina su mnogo manje izraženi u imunodeficijentnih životinja.
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).
Croatian: Potrebno je osigurati minimalno trajanje razdoblja prekinute opskrbe uda kisikom (najviše 20 minuta).
English: Therefore patients should be monitored during the first three days after the ILP.
Croatian: Stoga je potrebno pratiti bolesnike tijekom prva tri dana nakon izolirane perfuzije uda.
English: After lower limb perfusion, 3 to 6 litres should be used, and after upper limb perfusion, 1 to 2 litres.
Croatian: Nakon perfuzije donjeg uda za ispiranje je potrebno primijeniti 3 do 6 litara, a nakon perfuzije gornjeg uda 1 do 2 litre.
English: These include standard anaesthetic agents, analgesics, antipyretics, intravenous fluids, anticoagulants and vasopressor agents.
Croatian: One uključuju standardne anestetike, analgetike, antipiretike, intravenske tekućine, antikoagulanse i vazopresorne lijekove.
English: Colloids and hydroxyethyl starch fluids are preferred, as they are less likely to leak out of the vascular system.
Croatian: Preferiraju se koloidi i hidroksietilne škrobne tekućine jer je manja vjerojatnost njihovog istjecanja iz krvožilnog sustava.
English: Precautions to be taken before handling or administering the medicinal product When preparing and handling Beromun solutions, the use of gloves is recommended.
Croatian: Mjere opreza koje je potrebno poduzeti prije rukovanja ili primjene lijeka Pri pripremi i primjeni otopina Beromuna, preporučuje se uporaba rukavica.
English: The systemic pharmacokinetic information on tasonermin is sparse.
Croatian: Informacije o sistemskoj farmakokinetici za tasonermin su oskudne.
English: In approximately 2% of cases, Beromun may cause tissue damage in your affected arm or leg which is severe enough to require amputation.
Croatian: U oko 2 % slučajeva, Beromun može izazvati oštećenje tkiva u bolesnoj ruci ili nozi, dovoljno teško da opravdava amputaciju.
English: Infection, wound infection
Croatian: Infekcija, infekcija rane
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.
Croatian: Doze do 6 mg drugih TNFα pripravaka primjenjivane su u izoliranoj perfuziji uda, ali je utvrđeno da je ta doza neprihvatljiva u smislu regionalne toksičnosti.
English: What Beromun is and what it is used for What you need to know before you use Beromun How to use Beromun
Croatian: Što je Beromun i za što se koristi Što morate znati prije nego počnete primjenjivati Beromun Kako primjenjivati Beromun
English: Tasonermin did not cross the placenta or pass into necrotic tumour.
Croatian: Tasonermin nije prošao kroz posteljicu niti ušao u nekrotični tumor.
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.
Croatian: Perfuzijski krug (rotirajuća pumpa, oksigenator s integriranim spremnikom, izmjenjivač topline, povezne cjevčice) se mora pripremiti prije kirurškog zahvata te pripremiti s 700 do 800 ml perfuzata, s hematokritom od 0,25 do
English: Skin reaction
Croatian: Reakcije na koži
English: Contraindications to melphalan:
Croatian: Kontraindikacije za melfalan:
English: Further, adherence and extravasation of leukocytes is increased, leading to infiltration of the tumour by lymphocytes, monocytes, and granulocytes.
Croatian: Nadalje, pojačavaju se adhezija i ekstravazacija leukocita dovodeći tako do infiltracije tumora limfocitima, monocitima, i granulocitima.
English: Washout should be continued until the colour of the perfusate is clear pink, transparent (see section 4.4).
Croatian: Ispiranje se nastavlja dok perfuzat ne postane bistro ružičast, proziran (vidjeti dio 4.4).
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.
Croatian: Sistemska primjena tasonermina je ograničena svojim toksičnim učincima, a učinkovita doza predviđena u pretkliničkim ispitivanjima je značajno viša od maksimalne podnošljive doze u ljudi.
English: Altered renal function comprised increased water and sodium excretion as well as increased urea and creatinine.
Croatian: Promijenjena bubrežna funkcija uključivala je povećano izlučivanje vode i natrija, kao i povećane vrijednosti ureje i kreatinina.
English: Because of the unknown risk to the infant, breast-feeding is contraindicated within 7 days of ILP (see section 4.3).
Croatian: Zbog nepoznatog rizika za dojenče, dojenje je kontraindicirano tijekom 7 dana nakon izolirane perfuzije uda (vidjeti dio 4.3).
English: Extremity necrosis and compartment syndrome might be severe enough to warrant amputation.
Croatian: Nekroza ekstremiteta i kompartment sindrom mogu biti dovoljno teški da opravdavaju amputaciju.
English: Abdominal pain upper, gastritis erosive
Croatian: Bolovi u gornjem abdomenu, erozivni gastritis
English: Each vial contains 1 mg tasonermin.
Croatian: Svaka bočica sadrži 1 mg tasonermina.
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.
Croatian: Nadalje, potrebno je pratiti krvni tlak, diurezu i elektrokardiogram u prvih 24 do 48 sati nakon izolirane perfuzije uda, čak i kasnije, ako je indicirano.
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.
Croatian: Značajna kardiovaskularna bolest, npr. kongestivno zatajenje srca (stupanj II, III ili IV prema klasifikaciji Njujorškog kardiološkog društva), teška angina pektoris, srčane aritmije, infarkt miokarda unutar 3 mjeseca prije početka liječenja, venska tromboza, okluzivna periferna arterijska bolest, nedavna plućna embolija.
English: Haematological and circulatory changes, decreased well-being and weight gain as well as alterations in the function of liver and kidneys were the main adverse effects observed on repeated tasonermin administration.
Croatian: Hematološke i cirkulacijske promjene, lošije opće stanje i porast težine kao i promjene u funkciji jetre i bubrega bile su glavne nuspojave primijećene pri ponovljenoj primjeni tasonermina.
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).
Croatian: Direktni učinci na krvne žile tumora: Tasonermin utječe na morfologiju i smanjuje proliferaciju endotelnih stanica te modificira ekspresiju specifičnih proteina stanične površine i sekretornih proteina (uključujući adhezijske molekule i proteine koji moduliraju koagulaciju, interleukine i hematopoetske čimbenike rasta).