FrancophonIA/ELRC3.0 huggingface dataset:
English: Contents of the pack and other information
Croatian: Kako čuvati Beromun Sadržaj pakiranja i druge informacije
English: Sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, human serum albumin
Croatian: Natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat dodekahidrat, humani serumski albumin
English: EXP For single use only.
Croatian: Rok valjanosti Samo za jednokratnu primjenu.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL FOR BEROMUN
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI ZA BEROMUN
English: Powder vial Type I glass vial with chlorobutyl rubber stopper and sealed with aluminium flip-off cap.
Croatian: Bočica od stakla tipa I, s klorobutilnim gumenim čepom, zatvorena aluminijskim “flip-off“
English: Patients with contraindications to radioactive tracer monitoring.
Croatian: Bolesnici s kontraindikacijama za praćenje radioaktivnim izotopom.
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.
Croatian: Klasičnim testom za čimbenik nekroze tumora utvrđena je aktivnost tasonermina koja se sastoji od hemoragijske nekroze tumorskih nodula u mišjim singeničnim i ljudskim ksenogeničnim tumorskim sustavima nakon lokalne ili sistemske injekcije.
English: No reproduction toxicity or carcinogenicity studies were performed due to testing being inappropriate as the intended clinical use of Beromun is in ILP for soft tissue sarcoma treatment.
Croatian: Nisu provedena ispitivanja reproduktivne toksičnosti ili kancerogenosti budući da je Beromun namijenjen za kliničku primjenu u izoliranoj perfuziji uda za liječenje sarkoma mekog tkiva.
English: Severe lymphoedema of the limb.
Croatian: Teški limfedem uda.
English: During the ILP, central venous pressure and arterial pressure monitoring is strongly recommended.
Croatian: Tijekom izolirane perfuzije uda preporučuje se mjerenje centralnog venskog tlaka i arterijskog tlaka.
English: When necessary a second ILP can be considered 6-8 weeks after the first ILP.
Croatian: Prema potrebi, može se razmotriti ponavljanje izolirane perfuzije uda 6-8 tjedana nakon prve izolirane perfuzije uda.
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.
Croatian: Ako se pojave znakovi sistemske toksičnosti, na primjer vrućica, srčane aritmije, šok/hipotenzija, respiratorni distres sindrom odraslih osoba, potrebno je poduzeti opće potporno liječenje, a bolesnika odmah premjestiti u jedinicu intenzivnog liječenja radi nadzora.
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.
Croatian: Beromun je bijeli do bjelkasti prašak za otopinu za infuziju (prašak za infuziju) u staklenoj bočici s gumenim čepom, zatvorenoj aluminijskim “flip-off“ zatvaračem.
English: Common (may affect up to 1 in 10 people) - infections local wound infections reductions in numbers of certain white blood cells and platelets hypersensitivity (allergic) reactions nerve damage decreased consciouness headache heart problems which can cause shortness of breath or ankle swelling blood clot formation in the artery or vein of the affected arm or leg (thrombosis) - low blood pressure, shock - severe breathing problems - constipation, diarrhoea skin necrosis (death of skin cells) in the affected arm or leg swelling of the ankles, feet or fingers caused by fluid build up in the affected arm or leg “compartment syndrome”, a medical condition characterised by pain, swelling and neurological symptoms, as well as muscle damage in the affected arm or leg muscle pain - protein in urine night sweats tissue necrosis (death of tissue cells) in the affected arm or leg, which is severe enough to require amputation
Croatian: (alergijske) reakcije preosjetljivosti oštećenje živca smanjena svjesnost glavobolja problemi sa srcem koji mogu izavati nedostatak zraka i oticanje gležnjeva stvaranje krvnih ugrušaka u arteriji ili veni bolesne ruke ili noge (tromboza) - niski krvni tlak, šok - teški problemi s disanjem - zatvor, proljev nekroza kože (odumiranje stanica kože) na bolesnoj ruci ili nozi otečenost zglobova, stopala ili prstiju izazvana nakupljanjem tekućine u bolesnoj ruci ili nozi “kompartment sindrom”, medicinsko stanje karakterizirano bolovima, otečenošću i neurološkim simptomima, kao i oštećenjem mišića u bolesnoj ruci ili nozi bolovi u mišićima
English: The most frequent adverse reactions reported in clinical trials were fever, nausea, vomiting, fatigue, arrhythmia, chills, pain, wound infection and skin reaction.
Croatian: Najčešće nuspojave prijavljene u kliničkim ispitivanjima bile su vrućica, mučnina, povraćanje, umor,
English: A homogeneous solution will be obtained by shaking gently.
Croatian: Homogena otopina nastaje nježnom trešnjom.
English: If a second ILP is indicated, physicians should take into account the leakage rate of the previous ILP.
Croatian: Ako je indicirano ponavljanje izolirane perfuzije uda, liječnici moraju uzeti u obzir stopu propuštanja u prethodnom postupku izolirane perfuzije uda.
English: Cases of compartment syndrome characterised by pain, swelling and neurological symptoms, as well as muscle damage affecting the perfused limb have been observed in isolated patients treated with Beromun.
Croatian: Primjećeni su slučajevi kompartment sindroma karakteriziranog bolovima, otečenošću i neurološkim simptomima, kao i mišićno oštećenje perfundiranog uda u nekih bolesnika liječenih Beromunom.
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.
Croatian: Ako se pojave znakovi sistemske toksičnosti, na primjer vrućica, srčane aritmije, šok/hipotenzija, akutni respiratorni distres sindrom odraslih osoba, potrebno je primijeniti opće potporno liječenje, a bolesnika odmah premjestiti u jedinicu intenzivnog liječenja radi nadzora.
English: A condition called “compartment syndrome” may develop within the first three days after Beromun administration.
Croatian: Unutar tri dana nakon primjene Beromuna može se razviti stanje koje se naziva „kompartment sindrom“.
English: After that, melphalan will be added and the ILP continued for another 60 minutes.
Croatian: Nakon toga, dodaje se melfalan, a izolirani protok krvi uda se nastavlja sljedećih 60 minuta.
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.
Croatian: Značajna hematološka disfunkcija, npr. leukociti < 2,5 x 109/l, hemoglobin < 9 g/dl, trombociti
English: Adult respiratory distress syndrome
Croatian: Sindrom repiratornog distresa odraslih
English: Volume expanders and vasopressors are recommended.
Croatian: Preporučuje se nadoknada volumena i primjena vazopresornih lijekova.
English: Following the ILP, a standard wash-out procedure should always be employed, using dextran 70 intravenous infusion or similar fluid.
Croatian: Nakon izolirane perfuzije uda uvijek je potrebno provesti standardni postupak ispiranja uporabom intravenske infuzije dekstrana 70 ili slične tekućine.
English: Beromun contains sodium
Croatian: Beromun sadrži natrij
English: You will usually not receive a second ILP with Beromun.
Croatian: Obično nećete ponovno biti liječeni izoliranom perfuzijom uda i Beromunom.
English: Patients with contraindications to the use of anticoagulants.
Croatian: Bolesnici s kontraindikacijama za primjenu antikoagulansa.
English: The solution has a clear to light yellow colour.
Croatian: Otopina je prozirna do svijetložuta.
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.
Croatian: Nuspojave mogu biti povezane s Beromunom, melfalanom, ili postupkom izolirane perfuzije uda i povezanim terapijskim mjerama, ili s kombinacijom ovih čimbenika.
English: Sodium dihydrogen phosphate dihydrate Disodium phosphate dodecahydrate Human serum albumin.
Croatian: 6.1 Popis pomoćnih tvari natrijev dihidrogenfosfat dihidrat natrijev hidrogenfosfat dodekahidrat humani serumski albumin.
English: The powder is white to off-white.
Croatian: Bijeli do bjelkasti prašak.
English: When necessary a second ILP can be considered 6-8 weeks after the first ILP (see section 4.4).
Croatian: Prema potrebi, može se razmotriti druga izolirana perfuzija uda 6-8 tjedana nakon prve izolirane perfuzije uda (vidjeti dio
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 %.
Croatian: Brzinu protoka i zategnutost hemostatskog poveza može biti potrebno prilagođavati kako bi se ograničilo propuštanje iz perfuzijskog kruga u sistemsku cirkulaciju (postignut maksimum sistemske razine radioaktivnosti) da ne prelazi 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.
Croatian: Bolesnici kod kojih postoji sumnja na ovisnost krvne opskrbe dijela uda distalno od tumora o krvnim žilama tumora, što se može dokazati arteriogramom.
English: Beromun will be administered by a doctor who is experienced and skilled in isolated limb perfusion (ILP).
Croatian: Beromun će primjenjivati liječnik s iskustvom i dobrim poznavanjem postupka izolirane perfuzije uda.
English: Fever, chills, pain, fatigue
Croatian: Vrućica, zimica, bolovi, umor
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.
Croatian: Ovo liječenje trebaju provoditi kirurški timovi s iskustvom u liječenju sarkoma udova i provođenju postupka izolirane perfuzije uda u specijaliziranim ustanovama, s pripravnom jedinicom intenzivnog liječenja i opremom za kontinuirani nadzor zbog mogućeg propuštanja lijeka u sistemsku cirkulaciju.
English: Beromun 1 mg powder for infusion Tasonermin
Croatian: Beromun 1 mg prašak za infuziju tasonermin
English: Patients with contraindications to limb hyperthermia.
Croatian: Bolesnici s kontraindikacijama za hipertermiju uda.
English: Adverse reactions are either local, affecting the limb treated with ILP, or systemic.
Croatian: Nuspojave su ili lokalne, koje pogađaju ud liječen izoliranom perfuzijom uda ili sistemske.
English: Side effects may be caused by Beromun, melphalan, the ILP technique or a combination of these factors.
Croatian: Nuspojave mogu biti izazvane Beromunom, melfalanom, postupkom izoliranog protoka krvi uda ili kombinacijom ovih čimbenika.
English: The Summary of Product Characteristics for melphalan should be consulted for information on the interactions of melphalan.
Croatian: Potrebno je pogledati Sažetak opisa svojstava lijeka za melfalan radi informacija o interakcijama melfalana.
English: Beromun should be administered by mild hyperthermic ILP.
Croatian: Beromun se primjenjuje putem blage hipertermičke izolirane perfuzije uda.
English: Cardiac disorders Very common:
Croatian: Srčani poremećaji Vrlo često:
English: Please refer to the Summary of Product Characteristics of melphalan prior to commencing an ILP procedure.
Croatian: Molimo, pogledajte Sažetak opisa svojstava lijeka za melfalan prije započinjanja postupka izolirane perfuzije uda.
English: Please refer to the Summary of Product Characteristics for melphalan for details regarding incompatabilities with melphalan.
Croatian: Molimo, pogledajte Sažetak opisa svojstava lijeka za melfalan radi detalja koji se tiču inkompatabilnosti s melfalanom.
English: ILP 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.
Croatian: Izoliranu perfuziju uda moraju provoditi kirurški timovi s iskustvom u liječenju sarkoma udova i provođenju postupka izolirane perfuzije uda u specijaliziranim ustanovama, s pripravnom jedinicom intenzivnog liječenja i s opremom za kontinuirani nadzor zbog mogućnosti prelaska lijeka u sistemsku cirkulaciju.
English: Package leaflet: Information for the user Beromun 1 mg powder for solution for infusion
Croatian: Uputa o lijeku: Informacije za korisnika Beromun 1 mg prašak za otopinu za infuziju tasonermin
English: ILP allows the administration of high and fairly stable concentrations of tasonermin to the limb.
Croatian: Farmakokinetika u postupku izolirane perfuzije uda Izolirana perfuzija uda omogućuje primjenu visokih i prilično stabilnih koncentracija tasonermina u ud.
English: Uncommon (may affect up to 1 in 100 people) - blood poisoning (sepsis) - fluid in the lungs - stomach ache - inflammation of the gastric mucosa (gastritis) - temporary loss of finger or toe nails of the affected arm or leg - kidney failure - blood tests showing changes in the way the kidneys are working - narrowing or closing of limb vessels carrying blood from the heart
Croatian: - tupi bolovi u želucu - upala sluznice želuca (gastritis) - privremeni gubitak noktiju na prstima ruku ili nogu bolesne ruke ili noge - zatajenje bubrega - testovi krvi koji pokazuju promjene u radu bubrega - suženje ili zatvaranje žila nogu koje prenose krv iz srca
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.
Croatian: - ako imate ili ste nedavno imali čir na želucu - ako imate pretjerano nizak broj krvnih stanica ili poremećaje zgrušavanja krvi - ako imate umjerenu do tešku bolest jetre ili bubrega - ako ne možete uzimati vazopresorne lijekove (primjenjuju se za povišenje niskog krvnog tlaka),
English: The blood flow to and from your affected limb will be stopped using a tourniquet.
Croatian: Protok krvi u i iz bolesnog uda zaustavlja se pomoću hemostatskog poveza.
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.
Croatian: - forsirana diureza i alkalinizacija urina ako se pojavi oštećenje mišića s povišenim vrijednostima mioglobina u plazmi i urinu.
English: Artificial respiratory support may be required if ARDS develops.
Croatian: U slučaju razvoja respiratornog distres sindroma odraslih osoba, može biti potrebna primjena respiratora.
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.
Croatian: Beromuna mogu se postići primjenom paracetamola prije izolirane perfuzije uda (peroralno ili čepićem) ili drugog analgetika/antipiretika.
English: Peripheral arterial occlusive disease Respiratory, thoracic and mediastinal disorders Common:
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Često:
English: No NOTEL (No Observed Toxic Effect Level) could be established in the preclinical studies with the exception of a 7-day administration of 0.1 µg/kg in monkeys.
Croatian: Level; razina bez utvrđenih toksičnih učinaka) nije utvrđen u pretkliničkim ispitivanjima, s iznimkom
English: Contraindications to the ILP procedure:
Croatian: Kontraindikacije za Beromun:
English: Very common (may affect more than 1 in 10 people) - disturbances in your heart beat (arrhythmia) - feeling sick, vomiting - liver damage blistering of the skin fever (usually mild to moderate), chills pain in the affected arm or leg tiredness (fatigue)
Croatian: - osjećaj mučnine, povraćanje - oštećenje jetre stvaranje mjehurića na koži vrućica (obično blaga do umjerena), zimica bolovi u bolesnoj ruci ili nozi umor (iscrpljenost)
English: Contraindications to Beromun ILP, subdivided by components of the procedure, are: Contraindications to Beromun:
Croatian: Kontraindikacije za izoliranu perfuziju uda Beromunom, s obzirom na pojedinačne korake u postupku su:
English: Please refer to the Summary of Product Characteristics for melphalan for information on overdose of melphalan.
Croatian: Molimo, pogledajte Sažetak opisa svojstava lijeka za melfalan radi informacija o predoziranju melfalanom.
English: Patients with contraindications to the use of vasopressor substances.
Croatian: Bolesnici s kontraindikacijama za primjenu vazopresornih tvari.
English: Adverse reactions have been ranked under headings of frequency using the following convention:
Croatian: Opći poremećaji i reakcije na mjestu primjene Vrlo često:
English: Diarrhoea, constipation
Croatian: Proljev, konstipacija
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).
Croatian: Beromun je indiciran u odraslih osoba kao dodatno liječenje prije kirurškog uklanjanja tumora, a u svrhu sprječavanja ili odgode amputacije, ili kao palijativna terapija, kod neresektabilnog sarkoma mekog tkiva udova.
English: Please refer to the Summary of Product Characteristics for melphalan.
Croatian: Molimo, proučiti Sažetak opisa svojstava lijeka za melfalan.
English: Arrhythmia
Croatian: Aritmije
English: Skin and subcutaneous tissue disorders Very common:
Croatian: Poremećaji kože i potkožnog tkiva
English: If you get any side effects , talk to your doctor.
Croatian: Ako primjetite bilo koju nuspojavu, potrebno je obavijestiti liječnika.
English: Onychomadesis (loss of nails) Musculoskeletal and connective tissue disorders Common:
Croatian: Onihomadeza (gubitak noktiju) Poremećaji mišićno-koštanog sustava i vezivnog tkiva
English: Powder for solution for infusion 4 vials of powder for solution for infusion
Croatian: 4 bočice praška za otopinu za infuziju
English: Beromun 1 mg powder for solution for infusion
Croatian: Beromun 1 mg prašak za otopinu za infuziju
English: Name and address of the manufacturer of the biological active substance
Croatian: PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I
English: Batch
Croatian: Sepsa
English: Beromun will be administered by isolated limb perfusion (ILP), together with the anti-tumour agent melphalan.
Croatian: Beromun se primjenjuje putem izolirane perfuzije uda zajedno s antitumorskim lijekom melfalanom, što se provodi dok ste u besvjesnom stanju, pod općom anestezijom.
English: The solution of the reconstituted product should be inspected visually for particulate matter prior to administration.
Croatian: Prije primjene potrebno je pregledati sadrži li otopina rekonstituiranog lijeka čestice.
English: (ILP)
Croatian: NOTEL (engl.
English: Intraarterial use
Croatian: U arteriju
English: 9 to < 16 16 to 23 > 23 to 34
Croatian: 16 do 23 > 23 do 34
English: The following information is intended for healthcare professionals only PREPARATION GUIDE
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim djelatnicima UPUTE ZA PRIPREMU
English: Vials 2 years.
Croatian: 2 godine
English: Contact your doctor immediately if you get any of the following symptoms.
Croatian: Odmah obavijestite liječnika ukoliko primijetite bilo koji od navedenih simptoma.
English: There is no primary nor secondary graft rejection.
Croatian: Nije bilo primarnog niti sekundarnog odbacivanja presatka.
English: Paediatric population (0 to 17 years) The safety and efficacy of FB in pediatric population has not been established.
Croatian: Pedijatrijska populacija (0 do 17 godina) Sigurnost i djelotvornost FB-a u pedijatrijskoj populaciji nisu ustanovljene.
English: Incomplete development of teeth
Croatian: Nepotpun razvoj zubi.
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100) or not known (cannot be estimated from the available data).
Croatian: Učestalosti su definirane na sljedeći način: vrlo često (≥ 1/10), često (≥ 1/100, <1/10), manje često (≥1/1000,<1/100) ili nepoznato (ne mogu se procijeniti iz dostupnih podataka).
English: Y: body weight of the patient in kg
Croatian: Y: tjelesna težina bolesnika u kg
English: Not known (frequency cannot be estimated from the available data) Sex glands dysfunction
Croatian: Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka) Smetnje funkcije spolnih žlijezda.
English: See section 4.
Croatian: Pogledajte dio 4.4
English: 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 September 2014
Croatian: Datum prvog odobrenja: 22. rujna 2014.
English: Therefore busulfan should be used with caution in this type of patients.
Croatian: Stoga busulfan treba upotrebljavati s oprezom kod ovih bolesnika.
English: Busulfan is for single use only.
Croatian: Busulfan je samo za jednokratnu upotrebu.
English: Patients older than 50 years of age (n=23) have been successfully treated with busulfan without dose-adjustment.
Croatian: Bolesnici stariji od 50 godina (n=23) uspješno su liječeni busulfanom bez prilagođavanja doze.
English: CNS changes precede any of the more severe side effects.
Croatian: Promjene CNS-a prethode svakoj od težih nuspojava.
English: - The other ingredients are dimethylacetamide and macrogol 400.
Croatian: - Drugi sastojci su dimetilacetamid i makrogol 400.
English: Each vial contains 10 ml of concentrate.
Croatian: Svaka bočica sadrži 10 ml koncentrata.
English: Actual body weight (kg)
Croatian: Stvarna tjelesna težina (kg)
English: 60 mg per vial
Croatian: 60 mg po bočici
English: However, for the safe use of busulfan in patients older than 60 years only limited information is available.
Croatian: No, o sigurnoj primjeni busulfana u bolesnika starijih od 60 godina dostupni su samo ograničeni podaci.
English: Particular caution should be taken if you use itraconazol and metronidazole (used for certain types of infections) or ketobemidone (used to treat pain), because this may increase the side-effects.
Croatian: Osobito je potreban oprez ako upotrebljavate itrakonazol i metronidazol (upotrebljava se za određene tipove infekcija) ili ketobemidon (upotrebljava se za liječenje boli) jer to može povećati nuspojave.
English: HPCT is contraindicated in pregnant women; therefore, busulfan is contraindicated during pregnancy.
Croatian: HPCT je kontraindiciran u trudnica, stoga je busulfan kontraindiciran tijekom trudnoće.
English: The medicinal product is not recommended in obese children and adolescents with body mass index Weight (kg)/ (m2) > 30 kg/m² until further data become available.
Croatian: Primjena ovog lijeka ne preporučuje se u pretile djece i adolescenata s indeksom tjelesne mase težina (kg)/ (m2) > 30 kg/m² sve dok ne budu dostupni dodatni podaci.