natgillin/translations-raw huggingface dataset:
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.
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.
Package leaflet: Information for the user Beromun 1 mg powder for solution for infusion
Uputa o lijeku: Informacije za korisnika Beromun 1 mg prašak za otopinu za infuziju tasonermin
ILP allows the administration of high and fairly stable concentrations of tasonermin to the limb.
Farmakokinetika u postupku izolirane perfuzije uda Izolirana perfuzija uda omogućuje primjenu visokih i prilično stabilnih koncentracija tasonermina u ud.
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
- 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
- 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.
- 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),
The blood flow to and from your affected limb will be stopped using a tourniquet.
Protok krvi u i iz bolesnog uda zaustavlja se pomoću hemostatskog poveza.
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.
- forsirana diureza i alkalinizacija urina ako se pojavi oštećenje mišića s povišenim vrijednostima mioglobina u plazmi i urinu.
Artificial respiratory support may be required if ARDS develops.
U slučaju razvoja respiratornog distres sindroma odraslih osoba, može biti potrebna primjena respiratora.
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.
Beromuna mogu se postići primjenom paracetamola prije izolirane perfuzije uda (peroralno ili čepićem) ili drugog analgetika/antipiretika.
Peripheral arterial occlusive disease Respiratory, thoracic and mediastinal disorders Common:
Poremećaji dišnog sustava, prsišta i sredoprsja Često:
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.
Level; razina bez utvrđenih toksičnih učinaka) nije utvrđen u pretkliničkim ispitivanjima, s iznimkom
Contraindications to the ILP procedure:
Kontraindikacije za Beromun:
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)
- osjećaj mučnine, povraćanje - oštećenje jetre stvaranje mjehurića na koži vrućica (obično blaga do umjerena), zimica bolovi u bolesnoj ruci ili nozi umor (iscrpljenost)
Contraindications to Beromun ILP, subdivided by components of the procedure, are: Contraindications to Beromun:
Kontraindikacije za izoliranu perfuziju uda Beromunom, s obzirom na pojedinačne korake u postupku su:
Please refer to the Summary of Product Characteristics for melphalan for information on overdose of melphalan.
Molimo, pogledajte Sažetak opisa svojstava lijeka za melfalan radi informacija o predoziranju melfalanom.
Patients with contraindications to the use of vasopressor substances.
Bolesnici s kontraindikacijama za primjenu vazopresornih tvari.
Adverse reactions have been ranked under headings of frequency using the following convention:
Opći poremećaji i reakcije na mjestu primjene Vrlo često:
Diarrhoea, constipation
Proljev, konstipacija
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).
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.
Please refer to the Summary of Product Characteristics for melphalan.
Molimo, proučiti Sažetak opisa svojstava lijeka za melfalan.
Arrhythmia
Aritmije
Skin and subcutaneous tissue disorders Very common:
Poremećaji kože i potkožnog tkiva
If you get any side effects , talk to your doctor.
Ako primjetite bilo koju nuspojavu, potrebno je obavijestiti liječnika.
Onychomadesis (loss of nails) Musculoskeletal and connective tissue disorders Common:
Onihomadeza (gubitak noktiju) Poremećaji mišićno-koštanog sustava i vezivnog tkiva
Powder for solution for infusion 4 vials of powder for solution for infusion
4 bočice praška za otopinu za infuziju
Beromun 1 mg powder for solution for infusion
Beromun 1 mg prašak za otopinu za infuziju
Name and address of the manufacturer of the biological active substance
PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I
Batch
Sepsa
Beromun will be administered by isolated limb perfusion (ILP), together with the anti-tumour agent melphalan.
Beromun se primjenjuje putem izolirane perfuzije uda zajedno s antitumorskim lijekom melfalanom, što se provodi dok ste u besvjesnom stanju, pod općom anestezijom.
The solution of the reconstituted product should be inspected visually for particulate matter prior to administration.
Prije primjene potrebno je pregledati sadrži li otopina rekonstituiranog lijeka čestice.
(ILP)
NOTEL (engl.
Intraarterial use
U arteriju
9 to < 16 16 to 23 > 23 to 34
16 do 23 > 23 do 34
The following information is intended for healthcare professionals only PREPARATION GUIDE
Sljedeće informacije namijenjene su samo zdravstvenim djelatnicima UPUTE ZA PRIPREMU
Vials 2 years.
2 godine
Contact your doctor immediately if you get any of the following symptoms.
Odmah obavijestite liječnika ukoliko primijetite bilo koji od navedenih simptoma.
There is no primary nor secondary graft rejection.
Nije bilo primarnog niti sekundarnog odbacivanja presatka.
Paediatric population (0 to 17 years) The safety and efficacy of FB in pediatric population has not been established.
Pedijatrijska populacija (0 do 17 godina) Sigurnost i djelotvornost FB-a u pedijatrijskoj populaciji nisu ustanovljene.
Incomplete development of teeth
Nepotpun razvoj zubi.
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).
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).
Y: body weight of the patient in kg
Y: tjelesna težina bolesnika u kg
Not known (frequency cannot be estimated from the available data) Sex glands dysfunction
Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka) Smetnje funkcije spolnih žlijezda.
See section 4.
Pogledajte dio 4.4
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 September 2014
Datum prvog odobrenja: 22. rujna 2014.
Therefore busulfan should be used with caution in this type of patients.
Stoga busulfan treba upotrebljavati s oprezom kod ovih bolesnika.
Busulfan is for single use only.
Busulfan je samo za jednokratnu upotrebu.
Patients older than 50 years of age (n=23) have been successfully treated with busulfan without dose-adjustment.
Bolesnici stariji od 50 godina (n=23) uspješno su liječeni busulfanom bez prilagođavanja doze.
CNS changes precede any of the more severe side effects.
Promjene CNS-a prethode svakoj od težih nuspojava.
- The other ingredients are dimethylacetamide and macrogol 400.
- Drugi sastojci su dimetilacetamid i makrogol 400.
Each vial contains 10 ml of concentrate.
Svaka bočica sadrži 10 ml koncentrata.
Actual body weight (kg)
Stvarna tjelesna težina (kg)
60 mg per vial
60 mg po bočici
However, for the safe use of busulfan in patients older than 60 years only limited information is available.
No, o sigurnoj primjeni busulfana u bolesnika starijih od 60 godina dostupni su samo ograničeni podaci.
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.
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.
HPCT is contraindicated in pregnant women; therefore, busulfan is contraindicated during pregnancy.
HPCT je kontraindiciran u trudnica, stoga je busulfan kontraindiciran tijekom trudnoće.
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.
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.
It must be considered that overdose of busulfan will also increase exposure to DMA.
Potrebno je uzeti u obzir da će predoziranje busulfanom ujedno povećati izloženost DMA.
You should tell your doctor: - if you have a liver, kidney, heart or lung problem, - if you have a history of seizures, - if you are currently taking other medicines.
Obavijestite liječnika: - ako imate jetrene, bubrežne, srčane ili plućne tegobe, - ako ste u prošlosti doživjeli napadaje, - ako trenutno uzimate druge lijekove.
In both studies, all patients received a 16/16 dose regimen of busulfan.
U oba su ispitivanja svi bolesnici primili protokol sa 16/16 doza busulfana.
The treatment-related mortality/non-relapse mortality (TRM/NRM) reported until day+100 posttransplant has also been examined through a review of published data from clinical trials.
Smrtnost povezana s liječenjem/smrtnost (TRM/NRM) koja nije povezana s relapsom prijavljena do dana + 100 nakon presađivanja također je ispitana putem pregleda objavljenih podataka iz kliničkih ispitivanja.
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.
Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego primite terapiju lijekom Busulfan Fresenius Kabi.
In human the principal toxic effects were hepatotoxicity and central nervous system (CNS) effects.
Glavni toksični učinci kod ljudi bili su hepatotoksičnost i učinci na središnji živčani sustav (CNS).
This medicine contains the active substance busulfan, which belongs to a group of medicines called alkylating agents.
Ovaj lijek sadrži djelatnu tvar busulfan koja pripada skupini lijekova nazvanih alkilirajuće tvari.
Dose and administration The dose of busulfan will be calculated according to your body weight.
Doziranje i primjena: Doza lijeka Busulfan izračunat će se u skladu s Vašom tjelesnom težinom.
Antiemetics should be administered prior to the first dose of busulfan and continued on a fixed schedule according to local practice through its administration.
Antiemetike treba primijeniti prije prve doze busulfana i nastaviti s njihovom primjenom prema dogovorenom rasporedu u skladu s lokalnom praksom.
Pharmacotherapeutic group: Antineoplastic agents, alkylating agents, alkyl sulfonates, ATC code: L01AB01.
Farmakoterapijska skupina: antineoplastici, alkilirajući pripravci, alkilsulfonati ATK oznaka: L01AB01.
Polycarbonate syringes must not be used with busulfan.
Polikarbonatne štrcaljke ne smiju biti korištene s busulfanom.
However, more than 500 patients aged ≥ 55 years were reported in publications with FB conditioning regimens, yielding efficacy outcomes similar to younger patients.
Međutim, u publikacijama je zabilježeno da je više od 500 bolesnika u dobi od ≥ 55 godina s protokolima kondicioniranja FB-om imalo ishod djelotvornosti sličan mlađim bolesnicima.
Busulfan Fresenius Kabi can also produce symptoms of menopause and in pre-adolescent girls it can prevent the onset of puberty.
Busulfan Fresenius Kabi može također uzrokovati simptome menopauze i u preadolescentnih djevojaka može spriječiti početak puberteta.
Busulfan should not be given by rapid intravenous, bolus or peripheral injection.
Busulfan se ne smije primjenjivati brzom intravenskom, bolusnom ili perifernom injekcijom.
The information presented on biotransformation and elimination is based on oral busulfan.
Informacije o biotranformaciji i eliminaciji temelje se na peroralnom busulfanu.
Studies in animals have shown reproductive toxicity (embryo-foetal lethality and malformations) (see section 5.3)
Ispitivanja na životinjama pokazala su reproduktivnu toksičnost (embriofetalnu smrtnost i malformacije) (vidjeti dio 5.3).
Detailed information on this medicinal product is available on the website of European Medicinal Agency http://www.ema/europa.eu
Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove http://www.ema/europa.eu
Veno occlusive disease (VOD) was reported in 15% (4/27) and 7% (2/28) of the autologous and allogenic transplant respectively.
Vensko-okluzivna bolest (VOD) prijavljena je u 15% (4/27) autolognih i 7% (2/28) alogenih presađivanja.
Caution should be exercised when using paracetamol prior to (less than 72 hours) or concurrently with busulfan due to a possible decrease in the metabolism of busulfan (See section 4.5).
Potreban je oprez pri primjeni paracetamola prije (manje od 72 sata) ili istodobno s busulfanom zbog mogućeg skraćenja metabolizma busulfana (vidjeti dio 4.5).
A total of 11 patients (18%) experienced a-GVHD.
Ukupno je 11 bolesnika (18%) doživjelo a-GVHD.
Hepato-biliary disorders VOD was reported with a range between 3.9% and 15.4%.
Poremećaji jetre i žuči VOD je prijavljen u rasponu između 3,9% i 15,4%.
*veno occlusive liver disease is more frequent in paediatric population.
* vensko-okluzivna bolest jetre češća je u pedijatrijskoj populaciji.
The use of paracetamol during the 72 hours prior to or with Busulfan Fresenius Kabi administration should be used with caution.
Upotreba paracetamola tijekom 72 sata prije ili zajedno s primjenom lijeka Busulfan Fresenius Kabi mora se primijeniti s oprezom.
As documented in clinical studies, no treated patients experienced cardiac tamponade or other specific cardiac toxicities related to busulfan.
Kao što je dokumentirano u kliničkim ispitivanjima, nije bilo liječenih bolesnika koji su doživjeli kardijalnu tamponadu ili ostale specifične kardijalne toksičnosti povezane s busulfanom.
Overall mortality and non-relapse mortality at more than 100 days post-transplant was (8/61) 13% and (6/61) 10% in allotransplanted patients, respectively.
Ukupna smrtnost i smrtnost bez relapsa na više od 100 dana nakon presađivanja bila je (8/61) 13%, odnosno (6/61) 10% u alotransplantiranih bolesnika.
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.
U skupini od 205 djece provedena je populacijska farmakokinetička analiza koja je bila raspoređena na odgovarajući način u skladu s tjelesnom težinom (3,5 do 62,5 kg), biološkim svojstvima i svojstvima oboljenja (maligna i nemaligna) te prema tome reprezentativna za visoku heterogenost djece koja su podvrgnuta HPCT-u.
For the 40% of children < 9 kg outside the target, the AUC was evenly distributed either below or above the targeted limits; i.e. 20% each < 900 and > 1500 µmol/L.min following 1 mg/kg.
Za 40% djece s težinom < 9 kg izvan cilja, AUC se ravnomjerno rasporedio ili ispod ili iznad ciljnih ograničenja; tj. po 20% < 900 i > 1500 μmol/l.min nakon 1 mg/kg.
Investigations: elevated liver enzymes and weight increased.
Pretrage: povišeni jetreni enzimi, povećanje težine.
The most frequent infectious adverse reactions were Cytomegalovirus (CMV) reactivation [range: 30.7% - 80.0%], Epstein-Barr Virus (EBV) reactivation [range: 2.3% - 61%], bacterial infections [range: 32.0% - 38.9%] and viral infections [range: 1.3% - 17.2%].
Najčešće infekcijske nuspojave bile su reaktivacija citomegalovirusa (CMV) [raspon: 30,7% - 80,0%], reaktivacija Epstein-Barrovog virusa (EBV) [raspon: 2,3% - 61%], bakterijske infekcije [raspon: 32,0%38,9%] i virusne infekcije [raspon: 1,3% - 17,2%].
Busulfan should be administered by intravenous infusion via central venous catheter.
Busulfan treba primijeniti intravenskom infuzijom putem centralnog venskog katetera.
RECOMMENDATION FOR SAFE HANDLING Procedures for proper handling and disposal of anticancer medicinal products should be considered.
Treba razmotriti postupke za pravilno rukovanje i zbrinjavanje lijekova protiv raka.
It is recommended to administer anticonvulsants 12 h prior to busulfan to 24 h after the last dose of busulfan.
Preporučuje se primjena antikonvulzivnih lijekova 12 sati prije davanja busulfana do 24 sata nakon zadnje doze busulfana.
It is recommended when treating these patients that serum transaminase, alkaline phosphatase, and bilirubin should be monitored regularly 28 days following transplant for early detection of hepatotoxicity.
Preporučuje se da se prilikom liječenja tih bolesnika redovito prate serumske transaminaze, alkalna fosfataza i bilirubin, 28 dana nakon presađivanja kako bi se rano otkrila hepatotoksičnost.
Women must not be pregnant during treatment with Busulfan Fresenius Kabi and up to 6 months after treatment.
Žene ne smiju ostati trudne tijekom liječenja lijekom Busulfan Fresenius Kabi i do 6 mjeseci nakon liječenja.
Each vial is sleeved with shrinkable plastic film.
Svaka bočica je omotana toploskupljajućom plastičnom folijom.
- If the concentrate or diluted busulfan solution contacts the skin or mucosa, wash them thoroughly with water immediately.
- Ako koncentrat ili razrijeđeni busulfan dođe u doticaj s kožom ili sluznicom, odmah ih temeljito operite vodom.
No specific clinical trial was carried out to assess drug-drug interaction between intravenous busulfan and itraconazole or metronidazole.
Nisu provedena specifična klinička ispitivanja za procjenu lijek-lijek interakcije između intravenskog busulfana i itrakonazola ili metronidazola.
Published studies in adults described that ketobemidone (analgesic) might be associated with high levels of plasma busulfan.
U objavljenim ispitivanjima na odraslima opisano je da ketobemidon (analgetik) može biti povezan s visokim razinama busulfana u plazmi.
Like all medicines, Busulfan Fresenius Kabi can cause side effects, although not everybody gets them.
Kao i svi lijekovi, Busulfan Fresenius Kabi može uzrokovati nuspojave iako se neće javiti kod svakoga.
Adverse reactions information is derived from two clinical trials (n=103) of busulfan.
Informacije o nuspojavama dobivene su iz dva klinička ispitivanja (n=103) busulfana.
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 the above-mentioned conditions when dilution has taken place in controlled and validated aseptic conditions.
Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja prije primjene su odgovornost korisnika i ne bi trebali biti dulji od gore navedenih uvjeta, kada je razrjeđivanje provedeno u kontroliranim i validiranim aseptičkim uvjetima.
In new-born infants, children and adolescents, this medicine is used in combination with cyclophosphamide or melphalan.
Kod novorođenčadi, djece i adolescenata ovaj lijek se primjenjuje u kombinaciji s ciklofosfamidom ili melfalanom.
Gastrointestinal disorders The highest frequency of nausea and vomiting was 59.1% and the highest frequency of stomatitis was
Poremećaji probavnog sustava Najveća učestalost mučnine i povraćanja iznosila je 59,1%, a najveća učestalost stomatitisa iznosila je
Since busulfan is mainly metabolized through the liver, caution should be observed when busulfan is used in patients with pre-existing impairment of liver function, especially in those with severe hepatic impairment.
Budući da se busulfan većinom metabolizira putem jetre, potreban je oprez kada se busulfan primjenjuje u bolesnika koji već imaju oštećenje funkcije jetre, naročito u onih s teškim oštećenjem funkcije jetre.
The consequence of treatment with busulfan at the recommended dose and schedule is profound myelosuppression, occurring in all patients.
Posljedica liječenja busulfanom u preporučenoj dozi i rasporedu je teška mijelosupresija koja se javlja u svih bolesnika.
Busulfan is metabolised mainly through conjugation with glutathione (spontaneous and glutathione-S-transferase mediated).
Busulfan se većinom metabolizira konjugacijom s glutationom (spontano i sudjelovanjem glutation-S-transferaze).
Before receiving Busulfan Fresenius Kabi, you will be medicated with - anticonvulsive medicines to prevent seizures (phenytoin or benzodiazepines) and - antiemetic medicines to prevent vomiting.
Prije primanja lijeka Busulfan Fresenius Kabi, dobit ćete lijekove - antikonvulzivne lijekove za sprječavanje napadaja (fenitoin ili benzodiazepine) i - antiemetike za sprječavanje povraćanja.
Adequate contraceptive precautions should be used when either partner is receiving Busulfan Fresenius Kabi.
Moraju se primijeniti odgovarajuće mjere kontracepcije kada bilo koji od partnera prima Busulfan Fresenius Kabi.
It is possible that use of Busulfan Fresenius Kabi may increase the risk of suffering another malignancy in the future.
Moguće je da upotreba lijeka Busulfan Fresenius Kabi može povećati opasnost od obolijevanja od druge maligne bolesti u budućnosti.
However cardiac function should be monitored regularly in patients receiving busulfan (see section 4.8).
No kardijalna se funkcija mora redovito nadzirati u bolesnika koji primaju busulfan (vidjeti dio 4.8).
Busulfan dose (mg/kg)
Doza busulfana (mg /kg)
From a microbiological point of view, the product should be used immediately after dilution.
S mikrobiološkog stajališta, lijek treba primijeniti odmah nakon razrijeđivanja.
- the contents of the syringe must be dispensed into an intravenous bag (or syringe) which already contains the calculated amount of the selected diluent.
- sadržaj štrcaljke mora se ubrizgati u intravensku vrećicu (ili štrcaljku) koja već sadrži izračunatu količinu odabranog otapala.