FrancophonIA/ELRC3.0 huggingface dataset:
English: However, should this occur, your doctor will immediately wash out your affected limb to remove Beromun, and the ILP will be stopped.
Slovenian: Če do njega pride, bo zdravnik zdravilo Beromun takoj z izpiranjem odstranil iz okončine, postopek izolirane perfuzije pa končal.
English: Patients with contraindications to the use of vasopressor agents.
Slovenian: Bolniki, pri katerih je kontraindicirana uporaba vazopresornih učinkovin
English: 3 years
Slovenian: 60 minut.
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.
Slovenian: Raziskav o vplivu na razmnoževanje ali o kancerogenosti niso izvajali, ker je testiranje neustrezno glede na to, da je zdravilo
English: Severe pulmonary dysfunction.
Slovenian: trombocitopenijo in motnje strjevanja.
English: For administration by ILP Intraarterial use
Slovenian: Za uporabo v postopku izolirane perfuzije okončin intraarterijska uporaba
English: A homogeneous solution will be obtained by shaking gently.
Slovenian: Homogeno raztopino pripravimo tako, da jo narahlo stresamo.
English: Beromun 1 mg powder for infusion Tasonermin
Slovenian: Beromun 1 mg prašek za raztopino za infundiranje tasonermin
English: Sodium dihydrogen phosphate dihydrate Disodium phosphate dodecahydrate Human serum albumin.
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev dihidrogenfosfat dihidrat natrijev hidrogenfosfat dodekahidrat humani serumski albumin
English: The duration of the perfusion including melphalan should be 60 minutes.
Slovenian: Perfuzija, med katero dodamo melfalan, naj traja
English: The Summary of Product Characteristics for melphalan should be consulted for information on the interactions of melphalan.
Slovenian: Podatke o medsebojnem delovanju melfalana z drugimi zdravili je treba pregledati v povzetku glavnih značilnosti melfalana.
English: The recommended dose of Beromun depends on the affected limb, usually 3 mg for the arm and 4 mg for the leg. Beromun powder has to be dissolved before use.
Slovenian: 3 mg, če je prizadeta roka, in 4 mg, če je prizadeta noga.
English: The perfusion should be terminated if the cumulative leakage into the systemic circulation is > 10%.
Slovenian: Če je skupno uhajanje > 10 %, moramo perfuzijo prekiniti.
English: Adult respiratory distress syndrome
Slovenian: sindrom dihalne stiske pri odraslem občasni:
English: Extremity necrosis, severe enough to warrant amputation
Slovenian: huda nekroza okončine pri kateri je potrebna amputacija
English: Patients with contraindications to radioactive tracer monitoring.
Slovenian: Bolniki, pri katerih je kontraindicirana uporaba antikoagulansov Bolniki, pri katerih je kontraindicirano spremljanje z radioaktivnim sledilom Bolniki, pri katerih je kontraindicirana hipertermija okončine
English: Pharmacokinetics in ILP
Slovenian: Farmakokinetika pri izolirani perfuziji okončine
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.
Slovenian: perfuzijske raztopine med 7,2 in 7,35, vbrizgamo zdravilo Beromun v obliki bolusa v arterijski vod obtoka.
English: Please refer to the Summary of Product Characteristics for melphalan.
Slovenian: Podatki so navedeni v Povzetku glavnih značilnosti melfalana.
English: Renal failure acute General disorders and administration site conditions Very common:
Slovenian: Splošne težave in spremembe na mestu aplikacije zelo pogosti:
English: Beromun and then melphalan are injected into this circuit, over a total of 90 minutes the affected limb will be exposed to Beromun.
Slovenian: Zdravilo Beromun in nato melfalan vbrizgajo v ta krogotok.
English: Cardiac failure
Slovenian: akutna ledvična okvara
English: Surgical resection of the tumour remnant should be undertaken whenever possible.
Slovenian: Če je le možno, preostanek tumorja kirurško odstranimo.
English: Arrhythmia
Slovenian: Odmerjanje
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.
Slovenian: Pri posameznih bolnikih, ki so prejeli zdravilo Beromun, so poročali o utesnitvenem sindromu (kompartment sindromu), za katerega so bili značilni bolečina, oteklina in nevrološki simptomi ter poškodba mišic perfundirane okončine.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER (S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: Batch
Slovenian: sepsa
English: As Beromun is always administered by experienced and qualified hospital doctors, accidental overdose is extremely unlikely.
Slovenian: Če ste uporabili večji odmerek zdravila Beromun, kot bi smeli Ker uporabljajo zdravilo Beromun le izkušeni zdravniki, usposobljeni za njegovo uporabo, je nenameren vnos prevelikega odmerka zelo malo verjeten.
English: Please refer to the Summary of Product Characteristics for melphalan for information on overdose of melphalan.
Slovenian: Podatke o prevelikem odmerjanju melfalana preberite v povzetku glavnih značilnosti melfalana.
English: You will usually not receive a second ILP with Beromun.
Slovenian: Postopka izolirane perfuzije z zdravilom Beromun vam najbrž ne bodo ponovili.
English: The solution of the reconstituted product should be inspected visually for particulate matter prior to administration.
Slovenian: Pripravljeno raztopino je treba pred uporabo pregledati, da bi odkrili, ali ne vsebuje delcev.
English: Beromun 1 mg powder for solution for infusion
Slovenian: Beromun 1 mg prašek za raztopino za infundiranje
English: Adverse reactions have been ranked under headings of frequency using the following convention:
Slovenian: Tabelarični seznam neželenih učinkov Neželeni učinki so po pogostnosti razvrščeni v naslednje skupine:
English: During the IPL and the seven to ten day period afterwards you will need to stay in hospital, your doctor will carefully monitor your blood pressure, circulation and any side effects.
Slovenian: Med postopkom izolirane perfuzije in še sedem do deset dni zatem boste morali ostati v bolnišnici.
English: Hepatobiliary disorders Very common:
Slovenian: Infekcijske in parazitske bolezni pogosti:
English: Pregnancy and lactation (see section 4.6).
Slovenian: Sočasno zdravljenje s kardiotoksičnimi učikovinami (npr. antraciklini) Nosečnost in dojenje (glejte poglavje 4.6)
English: A number of therapeutic measures are routinely used during the ILP and in the immediate post-operative period.
Slovenian: Med izolirano perfuzijo okončine in neposredno po operaciji bolniku rutinsko dajemo več zdravil.
English: Please refer to the Summary of Product Characteristics for melphalan for details regarding incompatabilities with melphalan.
Slovenian: Podrobne podatke o inkompatibilnosti melfalana vsebuje Povzetek glavnih značilnosti melfalana.
English: No significant interactions have so far been noted, but caution should be exercised (see section 4.5).
Slovenian: je potrebna previdnost (glejte poglavje 4.5).
English: You may have to stay in an intensive care unit (ICU) directly after the ILP for a short time.
Slovenian: Takoj po postopku izolirane perfuzije boste lahko krajši čas na oddelku za intenzivno nego.
English: A recent history of, or active peptic ulcer.
Slovenian: Obstoječa aktivna peptična razjeda ali takšna razjeda v novejši anamnezi
English: Powder for solution for infusion (powder for infusion).
Slovenian: prašek za raztopino za infundiranje (prašek za infuzijo) Prašek je bel do sivo-bel.
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.
Slovenian: Najpomembnejši neželeni učinki po ponovljenem dajanju tasonermina so bile hematološke spremembe in spremembe krvnega obtoka, poslabšano počutje in povečanje telesne mase ter spremembe jetrne in ledvične funkcije.
English: Please refer to the Summary of Product Characteristics of melphalan prior to commencing an ILP procedure.
Slovenian: Preden boste začeli postopek izolirane perfuzije okončine, preberite Povzetek glavnih značilnosti melfalana.
English: No significant interactions have so far been noted, but caution should be exercised (see section 4.4).
Slovenian: je potrebna previdnost (glejte poglavje 4.4).
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
Slovenian: - nastanek krvnega strdka v arteriji ali veni prizadete roke ali noge (tromboza); - nizek krvni tlak, šok; - hude težave z dihanjem; - zaprtje, driska; - kožne nekroze (odmiranje kožnih celic) v prizadeti roki ali nogi;
English: Uncommon:
Slovenian: aritmija pogosti:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL FOR BEROMUN
Slovenian: OVOJNINAH NALEPKA NA VIALI ZA BEROMUN
English: Vascular disorders Common:
Slovenian: Žilne bolezni pogosti:
English: How to store Beromun
Slovenian: Shranjevanje zdravila Beromun
English: Package size
Slovenian: Velikost pakiranja infundiranje
English: These measures will help protect environment.
Slovenian: Taki ukrepi pomagajo varovati okolje.
English: 9 to < 16 16 to 23 > 23 to 34
Slovenian: 9 do 16 16 do 23 23 do 34
English: In new-born infants, children and adolescents (0 to 17 years):
Slovenian: Pri novorojenčkih, otrocih in mladostnikih (od 0 do 17 let):
English: Therefore careful monitoring will be performed.
Slovenian: Zaradi tega boste pod skrbnim nadzorom.
English: At the recommended dose, this is the desired effect.
Slovenian: Ob priporočenih odmerkih je to želeni učinek.
English: Contact your doctor immediately if you get any of the following symptoms.
Slovenian: Takoj povejte zdravniku, če se vam pojavi kateri od naslednjih simptomov.
English: Incomplete development of teeth
Slovenian: Nepopoln razvoj zobovja.
English: Vials 2 years.
Slovenian: 2 leti
English: Each infusion will last 2 hours
Slovenian: - Vsaka infuzija bo trajala 2 uri.
English: Infections.
Slovenian: Infekcije.
English: Not known (frequency cannot be estimated from the available data) Sex glands dysfunction
Slovenian: Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti) Disfunkcija spolnih žlez.
English: No dose adjustment was deemed necessary.
Slovenian: Prilagoditev odmerka ni bila potrebna.
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).
Slovenian: Pogostnost pojavljanja je opredeljena kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100) ali neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Patients should receive adequate anticonvulsant prophylaxis.
Slovenian: Bolnikom je potrebno zagotoviti primerno antikonvulzivno profilakso.
English: The administration of FB regimen has not been specifically investigated in elderly patients.
Slovenian: Uporaba sheme FB ni posebej raziskana pri starejših bolnikih.
English: Paediatric population (0 to 17 years) The safety and efficacy of FB in pediatric population has not been established.
Slovenian: Pediatrična populacija (0-17 let) Varnost in učinkovitost sheme FB pri pediatrični populaciji nista ugotovljeni.
English: However, caution is recommended (see sections 4.8 and 5.2).
Slovenian: Vseeno je potrebna previdnost (glejte poglavji 4.8 in 5.2).
English: The following information is intended for healthcare professionals only PREPARATION GUIDE
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju:
English: *veno occlusive liver disease is more frequent in paediatric population.
Slovenian: * veno-okluzivna jetrna bolezen je pogostejša pri pediatrični populaciji
English: Hypogonadism**
Slovenian: Hipogonadizem**
English: Patients older than 50 years of age (n=23) have been successfully treated with busulfan without dose-adjustment.
Slovenian: Bolniki, starejši od 50 let (n = 23), so bili uspešno zdravljeni z busulfanom brez prilagoditve odmerka.
English: 39% of patients (40/103) experienced one or more episodes of infection, of which 83% (33/40) were rated as mild or moderate.
Slovenian: 39 % bolnikov (40/103) je izkusilo eno ali več epizod infekcij, od katerih jih je bilo 83 % (33/40) ocenjenih za blago ali zmerno.
English: If you are concerned about having children, you should discuss this with your doctor before treatment.
Slovenian: Če vas skrbi, da ne boste mogli imeti otrok, se pred začetkom zdravljenja o tem posvetujte z zdravnikom.
English: 60 mg per vial
Slovenian: 60 mg v vsaki viali
English: Each vial contains 10 ml of concentrate.
Slovenian: Vsaka viala vsebuje 10 ml koncentrata.
English: Do not use this medicine after the expiry date which is stated on the vial label and the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki na viali in na škatli poleg oznake EXP.
English: Chronic GVHD was reported only if it is the cause of death: one patient died 13 months post-transplant.
Slovenian: O kronični GVHD so poročali le, če je bila vzrok smrti: 1 bolnik je umrl 13 mesecev po transplantaciji.
English: Grade 3 elevated transaminases were reported in 24% of patients.
Slovenian: O povišani ravni transaminaz 3 stopnje so poročali pri 24 % bolnikov.
English: Reversible binding to plasma proteins was around 7% while irreversible binding, primarily to albumin, was about 32%.
Slovenian: Reverzibilna vezava na plazemske beljakovine je bila približno 7 %, medtem ko je bila ireverzibilna vezava, predvsem na albumin, približno 32 %.
English: HPCT is contraindicated in pregnant women; therefore, busulfan is contraindicated during pregnancy.
Slovenian: HPCT je kontraindicirana pri nosečnicah, zato je busulfan kontraindiciran med nosečnostjo.
English: Approximately 30% of the administered dose is excreted into the urine over 48 hours with 1% as unchanged busulfan.
Slovenian: Približno 30 % uporabljenega odmerka se v 48 urah izloči z urinom, od tega 1 % v obliki nespremenjenega busulfana.
English: The terminal half-life ranged from 2.8 to 3.9 hours.
Slovenian: Končni razpolovni čas je bil med 2,8 in 3,9 ure.
English: Total dose of busulfan per patient was between 6.4 mg/kg and 9.6 mg/kg.
Slovenian: Celotni odmerek busulfana na bolnika je bil med 6,4 mg/kg in 9,6 mg/kg.
English: Each vial is sleeved with shrinkable plastic film.
Slovenian: Vsaka vijala je ovita s skrčljivim plastičnim filmom.
English: Actual body weight (kg)
Slovenian: Dejanska telesna masa (kg)
English: Ask your pharmacist how to throw away medicine you no longer use.
Slovenian: O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.
English: A majority of publications reported a complete donor chimerism at day+30 for 90-100% of patients.
Slovenian: Večina objav je poročala o popolnem donorskem himerizmu na dan + 30 pri od 90 do 100 % bolnikov.
English: From a microbiological point of view, the product should be used immediately after dilution.
Slovenian: Z mikrobiološkega stališča je potrebno zdravilo uporabiti takoj po redčenju.
English: 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 September 2014
Slovenian: Datum prve odobritve: 22.07.2014 Datum zadnjega podaljšanja:
English: Busulfan concentrations in the cerebrospinal fluid are comparable to those in plasma although these concentrations are probably insufficient for anti-neoplastic activity.
Slovenian: Koncentracije busulfana v cerebrospinalni tekočini lahko primerjamo s tistimi v plazmi, čeprav te koncentracije verjetno niso zadostne za antineoplastični učinek.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor before you receive treatment with Busulfan Fresenius Kabi.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom, preden prejmete zdravilo Busulfan Fresenius Kabi.
English: Patients who have received prior radiation therapy, greater than or equal to three cycles of chemotherapy, or prior progenitor cell transplant may be at an increased risk (see section 4.8).
Slovenian: Bolniki, ki so bili podvrženi predhodni radiacijski terapiji, večji ali enaki trem ciklom kemoterapije, ali predhodni transplantaciji progenitorskih celic, so izpostavljeni večjemu tveganju (glejte poglavje 4.8).
English: Detailed information on this medicinal product is available on the website of European Medicinal Agency http://www.ema/europa.eu
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Slovenian: V vsaki skupini pogostnosti so neželeni učinki razvrščeni po padajoči resnosti.
English: It was considered as deaths that could be attributable to secondary side effects after HPCT and not related to the relapse/progression of the underlying haematological malignancies.
Slovenian: Obravnavali so jo kot smrt, ki bi jo bilo mogoče pripisati sekundarnim neželenim učinkom po HPCT in nepovezano z recidivom/napredovanjem osnovne maligne hematološke bolezni.
English: Late haemorrhagic cystitis occurring 2 weeks post-transplant are likely related to viral infection / reactivation.
Slovenian: Pozni hemoragični cistitis, ki se pojavi 2 tedna po transplantaciji, je verjetno povezan z virusno okužbo/reaktivacijo virusa.
English: Paediatric population (0 to 17 years) The recommended dose of busulfan is as follows:
Slovenian: Pediatrična populacija (0-17 let) Priporočeni odmerki busulfana so:
English: In human the principal toxic effects were hepatotoxicity and central nervous system (CNS) effects.
Slovenian: Glavni toksični učinki pri človeku so hepatotoksičnost in učinki na centralni živčni sistem (CŽS).
English: Haemorrhagic cystitis including haemorrhagic cystitis induced by viral infection was reported in a range between 16% and 18.1%.
Slovenian: O hemoragičnem cistitisu, vključno s hemoragičnim cistitisom povzročenim z virusno okužbo, so poročali pri 16 do 18,1 %.
English: The occurrence of infectious episodes or reactivation of opportunistic infectious agents mainly reflects the immune status of the patient receiving a conditioning regimen.
Slovenian: Pojav okužb ali reaktivacije oportunističnih okužb je v glavnem odsev imunskega stanja bolnikov, ki prejemajo pripravljalno shemo.
English: RECOMMENDATION FOR SAFE HANDLING Procedures for proper handling and disposal of anticancer medicinal products should be considered.
Slovenian: Upoštevati morate ustrezne postopke za ravnanje in odstranjevanje zdravil proti raku.
English: The primary efficacy parameters in these studies were myeloablation, engraftment, relapse, and survival.
Slovenian: Primarni parametri učinkovitosti v teh raziskavah so bili mieloablacija, prijetje presadka, ponovljivost in preživetje.
English: As a result, the control of intravenous busulfan AUC within the therapeutic windows is not modified and a similar targeting performance between the two schedules was illustrated.
Slovenian: Zato se nadzor AUC intravenskega busulfana znotraj terapevtskega okna ni spremenil, prikazana pa je bila podobna ciljna zmogljivost obeh razporedov.
English: In both studies, all patients received a 16/16 dose regimen of busulfan.
Slovenian: Pri obeh raziskavah so vsi bolniki prejeli terapevtski odmerek 16/16 busulfana.
English: In adults
Slovenian: Odrasli
English: DMA decreases fertility in male and female rodents (see sections 4.6 and 5.3).
Slovenian: DMA zmanjšuje plodnost pri samcih in samicah glodavcev (glejte poglavji 4.6 in 5.3).
English: - If the concentrate or diluted busulfan solution contacts the skin or mucosa, wash them thoroughly with water immediately.
Slovenian: - Če koncentrat ali razredčena raztopina busulfana pride v stik s kožo ali sluznico, ju je takoj potrebno temeljito sprati z vodo.
English: Nevertheless the risk of liver toxicity may be increased in this population.
Slovenian: Vendar pa pri tej skupini bolnikov obstaja povečano tveganje toksičnosti za jetra.
English: Investigations: elevated liver enzymes and weight increased.
Slovenian: Preiskave: povišane vrednosti jetrnih encimov in povečanje telesne teže.
English: However, for the safe use of busulfan in patients older than 60 years only limited information is available.
Slovenian: Vendar so za varno uporabo busulfana pri bolnikih, starejših od 60 let, na voljo le omejeni podatki.
English: The review of the literature allows a comparison of PK series performed either within the same study or between studies and demonstrated unchanged dose-independent PK parameters regardless the dosage or the schedule of administration.
Slovenian: Pregled literature omogoča primerjavo farmakokinetičnih zaporedij, opravljenih bodisi znotraj ene študije, bodisi med študijami, in je pokazal nespremenjene, od odmerka neodvisne, farmakokinetične parametre, ne glede na odmerjanje ali razpored uporabe.
English: Busulfan is for single use only.
Slovenian: Busulfan je samo za enkratno uporabo.
English: It is possible that use of Busulfan Fresenius Kabi may increase the risk of suffering another malignancy in the future.
Slovenian: Obstaja možnost, da bo uporaba zdravila Busulfan Fresenius Kabi povečala tveganje za nastanek drugega malignega obolenja v prihodnosti.
English: CNS changes precede any of the more severe side effects.
Slovenian: Spremembe v CŽS nastopijo pred katerim koli hudim neželenim učinkom.
English: A population pharmacokinetic analysis has been performed in a cohort of 205 children adequately distributed with respect to bodyweight (3.5 to 62.5 kg), biological and diseases (malignant and non-malignant) characteristics, thus representative of the high heterogeneity of children undergoing HPCT.
Slovenian: Populacijska farmakokinetična analiza je bila izvedena pri skupini 205 otrok , z ustrezno zastopanostjo glede na telesno maso (3,6-62,5 kg) ter glede na biološke in bolezenske značilnosti (maligne in benigne bolezni) in je zato reprezentativna za visoko heterogenost otrok, podvrženih HPTC.
English: For obese patients, dosing based on adjusted ideal body weight (AIBW) should be considered.
Slovenian: Pri debelih bolnikih je treba razmisliti o odmerku, ki temelji na prilagojeni idealni telesni masi (AIBWAdjusted Ideal Body Weight).
English: Using a non polycarbonate syringe fitted with a needle:
Slovenian: - Z ne-polikarbonatno brizgo, na kateri je nameščena igla:
English: Other medicines and Busulfan Fresenius Kabi Tell your doctor if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.
Slovenian: Druga zdravila in zdravilo Busulfan Fresenius Kabi Obvestite svojega zdravnika, če jemljete,ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta.