natgillin/translations-raw huggingface dataset:
ILP allows that tumour cells in your limb can be exposed to a very high dose of Beromun and melphalan, enhancing their anti-tumour effect, but without reaching the rest of the body, where they could cause serious side effects.
Med postopkom izolirane perfuzije okončine so tomorske celice v okončini izpostavljene zelo velikima odmerkoma zdravila Beromun in melfalana, kar poveča njun protitumorski učinek, ne da bi zdravili prehajali v druge telesne dele, kjer bi lahko imeli resne neželene učinke.
Undesirable effects may be related to Beromun, to melphalan, or to the ILP procedure and associated measures, or to a combination of these factors.
Neželene učinke lahko imajo zdravilo Beromun, melfalan, postopek izolirane perfuzije ali kombinacija teh dejavnikov.
At ILP, no incompatibilities with other constituents of the perfusate, with hyperthermia or with the membrane oxygenator and the silicone tubing are known.
Pri izolirani perfuziji okončine niso znane inkompatibilnosti z drugimi sestavinami perfuzijske raztopine, s hipertermijo ali z membranskim oksigenatorjem ali silikonskimi cevkami.
Peripheral arterial occlusive disease Respiratory, thoracic and mediastinal disorders Common:
periferna arterijska okluzivna bolezen Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti:
Direct inhibition of tumour cell proliferation: Tasonermin is cytotoxic or cytostatic in vitro for a variety of tumour cell lines of different histogenesis.
Neposredno zaviranje proliferacije tumorskih celic: tasonermin deluje in vitro citotoksično ali citostatično na različne tumorske celične linije različne histogeneze.
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.
Vročino, mrzlico in druge gripozne simptome, ki so povezani z dajanjem zdravila Beromun, lahko preprečimo s paracetamolom (peroralno ali v obliki svečk) ali drugim analgetikom oz. antipiretikom pred posegom.
You must not breast-feed for at least seven days after treatment with Beromun.
Po zdravljenju z zdravilom Beromun najmanj sedem dni ne smete dojiti.
Hepatotoxicity
hepatotoksičnost
A Swan-Ganz catheter may be considered for monitoring pulmonary artery pressure and wedge pressure during the ILP and in the post-operative period.
Presoditi je treba o uporabi Swan-Ganzovega katetra za spremljanje tlaka pljučne arterije in zagozditvenega tlaka med izolirano perfuzijo okončine in v pooperativnem obdobju.
The blood flow to and from your affected limb will be stopped using a tourniquet.
Pretok krvi v prizadeto okončino in iz nje bodo zaustavili z zažemko.
External heat loss from the limb should be prevented by application of thermal blankets and limb temperature continuously monitored by thermistor probes inserted into subcutaneous tissue and muscle.
Izgubo toplote na površini okončine preprečimo z ogrevalnimi odejami in neprekinjenim spremljanjem njene temperature s termistorskimi sondami, vstavljenimi v podkožno tkivo in mišice.
No evidence has been found of any mutagenic effect, neither in vivo nor in vitro.
Niti in vivo niti in vitro raziskave niso pokazale nikakršnih mutagenih učinkov.
Skin necrosis, oedema peripheral
kožne nekroze, periferni edem občasni:
The maximum tolerated dose (MTD) of tasonermin for ILP is 4 mg, which is 10 times the systemic MTD.
Največji odmerek tasonermina za izolirano perfuzijo okončine, ki ga bolniki še prenašajo, je 4 mg, kar je 10 -krat več kot največji, še prenosljivi sistemski odmerek.
Because of the unknown risk to the infant, breast-feeding is contraindicated within 7 days of ILP (see section 4.3).
Ker ne poznamo tveganosti uporabe zdravila za dojenčke, je dojenje 7 dni po izolirani perfuziji okončine kontraindicirano (glejte poglavje 4.3).
Each pack contains 4 vials of powder.
V enem pakiranju so 4 viale praška.
Onychomadesis (loss of nails) Musculoskeletal and connective tissue disorders Common:
onihomadeza (izguba nohtov) Bolezni mišično-skeletnega sistema in vezivnega tkiva pogosti:
The loco-regional application of Beromun, along with melphalan, has been shown to be highly effective for local control of irresectable soft tissue sarcomas of the limbs.
Lokalnoregionalna uporaba zdravila Beromun ob hkratni uporabi melfalana je pri lokalnem nadzoru neoperabilnih sarkomov mehkega tkiva okončin pokazala visoko učinkovitost.
A condition called “compartment syndrome” may develop within the first three days after Beromun administration.
Prve tri dni po dajanju zdravila Beromun se lahko razvije stanje, ki ga imenujemo “utesnitveni sindrom”.
Wash-out should continue until a clear (pink, transparent) venous outflow is obtained.
Izpiramo, dokler ne priteče čisti (rožnati, prozorni) venozni izliv.
You must not use Beromun if you are pregnant.
Če ste noseči, zdravila Beromun ne smete uporabiti.
Patients with contraindications to the use of anticoagulants.
Bolniki, pri katerih je kontraindicirana uporaba antikoagulansov
Skin and subcutaneous tissue disorders Very common:
Bolezni kože in podkožja zelo pogosti:
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.
Če se pojavijo sistemski toksični znaki, na primer vročina, srčne aritmije, šok oz. hipotenzija ali sindrom dihalne stiske, je treba uvesti podporne ukrepe in bolnika takoj premestiti na oddelek za intenzivno zdravljenje na opazovanje.
Sepsis Blood and lymphatic system disorders Common:
Bolezni krvi in limfatičnega sistema pogosti:
Infection, wound infection
okužba, okužba rane občasni:
In addition, as the clinical situation dictates, a vasopressor agent, e.g. dopamine, can be considered for administration during the ILP procedure, as well as in the post-operative period.
Poleg tega lahko glede na klinično stanje presodimo tudi o uporabi vazopresornih učinkovin, npr. dopamina, ki ga dajemo med izolirano perfuzijo okončine ter v pooperativnem obdobju.
Late onset of peripheral arterial occlusive disease (PAOD) of the lower limbs has been reported in patients several years after ILP, predominantly in patients presenting with established cardiovascular risk factors, or who had undergone additional irradiation therapy of the concerned limb.
Več let po izolirani perfuziji okončine so poročali o poznem pojavu periferne arterijske okluzivne bolezni spodnjih okončin, pretežno pri bolnikih z znanimi dejavniki tveganja za bolezni srca in ožilja ali bolnikih, pri katerih so isto okončino dodatno zdravili z obsevanjem.
The container contains latex rubber
Vsebnik vsebuje naravno gumo (lateks)
Contents of the pack and other information
Shranjevanje zdravila Beromun Vsebina pakiranja in dodatne informacije
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.
Poleg tega je prvih 24 do 48 ur po izolirani perfuziji okončine ali dlje, kadar je indicirano, treba rutinsko nadzirati krvni tlak, izločanje seča in bolnika elektrokardiografsko spremljati.
What Beromun looks like and contents of the pack
Izgled zdravila Beromun in vsebina pakiranja
Blood creatinine increased Surgical and medical procedures Common:
zvišanje kreatinina v krvi Kirurški in drugi medicinski posegi pogosti:
Tasonermin does not cross the intact blood-brain barrier to a significant extent in mice.
Tasonermin pri miših pomembneje ne prehaja skozi nepoškodovano krvno-možgansko pregrado.
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.
Hud ascites Hujše hematološke motnje, npr. levkociti < 2,5 x 109/l, hemoglobin < 9 g/dl, trombociti < 60 x 109/l,
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).
Zdravilo Beromun je indicirano pri odraslih kot pomožni ukrep, ob poznejši kirurški odstranitvi tumorja, s katerim preprečimo ali odložimo amputacijo, ali pri paliativnem zdravljenju neoperabilnih sarkomov v mehkem tkivu okončin, v kombinaciji z melfalanom, z blago hipertermično izolirano perfuzijo okončine.
Beromun will be administered by a doctor who is experienced and skilled in isolated limb perfusion (ILP).
Zdravilo Beromun vam bo dajal izkušen zdravnik, ki je izurjen v uporabi tehnike izolirane perfuzije okončine.
Following the ILP, a standard wash-out procedure should always be employed, using dextran 70 intravenous infusion or similar fluid.
Po izolirani perfuziji okončine moramo vedno izvesti standardni postopek izpiranja z dekstranom 70 za intravensko infundiranje ali s podobno tekočino.
Upper limb: 3 mg total dose by ILP Lower limb: 4 mg total dose by ILP
Zgornja okončina: skupni odmerek po 3 mg z izolirano perfuzijo okončine Spodnja okončina: skupni odmerek po 4 mg z izolirano perfuzijo okončine
Powder for solution for infusion 4 vials of powder for solution for infusion
prašek za raztopino za infundiranje 4 viale praška za raztopino za infundiranje
If a second ILP is indicated, physicians should take into account the leakage rate of the previous ILP.
Če je indicirana ponovitev izolirane perfuzije okončine, mora zdravnik upoštevati stopnjo uhajanja zdravila v sistemski obtok med prvim postopkom.
Significant renal dysfunction, e.g. nephrotic syndrome, serum creatinine > 150 µmol/l, or creatinine clearance of < 50 ml/min.
hemoragična diateza ali aktivna krvavitev Hujše motnje ledvičnega delovanja, npr. nefrotični sindrom, serumski kreatinin > 150 µmol/l ali kreatininski očistek < 50 ml/min
Extremity necrosis and compartment syndrome might be severe enough to warrant amputation.
Nekroza okončine in utesnitveni sindrom, ki sta lahko tako huda, da je zaradi njiju potrebna amputacija.
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.
24 ur in 2 do 8 ºC, razen kadar raztopino pripravite v nadzorovanih in validiranih aseptičnih razmerah.
Beromun has been co-administered with interferon-gamma in the ILP setting but no added value has been demonstrated.
Zdravilo Beromun so v sklopu izolirane perfuzije okončine že dajali sočasno z interferonom gama, toda pokazalo se je, da ne prinaša dodatne koristi.
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.
Učinkovit odmerek, potreben glede na izsledke predkliničnih raziskav, je znatno večji kot največji odmerek, ki ga človek še prenese.
The resulting solution will be administered into an artery in your affected arm or leg by ILP for an initial period of 30 minutes.
Raztopino vnesejo v arterijo prizadete roke ali noge s postopkom izolirane perfuzije okončine za 30 minut.
Artificial respiratory support may be required if ARDS develops.
Če se razvije sindrom dihalne stiske, lahko bolnik potrebuje umetno predihavanje.
Fever, chills, pain, fatigue
vročina, mrzlica, bolečina, utrujenost pogosti:
If you get any side effects , talk to your doctor.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom.
Pulmonary oedema
pljučni edem
Contraindications to the ILP procedure:
Kontraindikacije za postopek izolirane perfuzije okončine:
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.
Zdravilo Beromun je bel do skoraj bel prašek za raztopino za infundiranje (prašek za infuzijo), pakiran v stekleno vialo z gumijastim zamaškom in tesnilno aluminijasto zaporko.
Concurrent administration of agents likely to cause significant hypotension is not recommended (see section 4.5).
Sočasnega dajanja zdravil, ki lahko povzročijo večjo hipotenzijo, ne priporočamo (glejte poglavje 4.5).
Melphalan dose should be calculated according to the litre-volume method of Wieberdink (Wieberdink J, Benckhuysen C, Braat RP, van Slooten EA, Olthius GAA.
Odmerek melfalana je treba izračunati po Wieberdinkovi litrsko-volumski metodi (Wieberdink J,
Clinical data however indicate that the overall incidence of adverse events is increased if patients are simultaneously exposed to tasonermin and interferon-gamma.
Vendar klinični podatki kažejo, da se pri bolnikih, ki hkrati prejemajo tasonermin in interferon gama, poveča pogostnost neželenih učinkov.
When necessary a second ILP can be considered 6-8 weeks after the first ILP.
Če je potrebno, presodimo o ponovni izolirani perfuziji okončine, ki jo lahko izvedemo 6 do 8 tednov po prvi.
Beromun contains sodium
Zdravilo Beromun vsebuje natrij
Concurrent administration of agents likely to cause significant hypotension is not recommended (see section 4.4).
Sočasnega dajanja zdravil, ki lahko povzročijo večjo hipotenzijo, ne priporočamo (glejte poglavje 4.4).
Cardiac disorders Very common:
Srčne bolezni zelo pogosti:
Powder vial Type I glass vial with chlorobutyl rubber stopper and sealed with aluminium flip-off cap.
Viala s praškom Viala iz stekla tipa I z gumijastim zamaškom iz klorobutila in tesnilno aluminijasto zaporko.
Severe ascites.
Hud ascites
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.
Zdravljenje lahko izvajajo le specializirani centri s kirurškimi ekipami, ki imajo izkušnje z zdravljenjem sarkomov okončin in s postopkom izolirane perfuzije okončin, in ki ima jo oddelek za intenzivno nego in opremo za neprekinjeno spremljanje uhajanja zdravila v sistemski obtok.
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.
Standardne histološke preiskave kože, mišic, kosti, živcev in žil razen blagega povečanja ishemije po večjih odmerkih niso pokazale razlik med izvidi pri živalih, ki so prejele tasonermin, in izvidi pri kontrolnih živalih.
Beromun will be administered by isolated limb perfusion (ILP), together with the anti-tumour agent melphalan.
Zdravilo Beromun boste prejeli s tehniko izolirane perfuzije okončine, hkrati s protitumorskih zdravilom melfalanom.
However, should this occur, your doctor will immediately wash out your affected limb to remove Beromun, and the ILP will be stopped.
Če do njega pride, bo zdravnik zdravilo Beromun takoj z izpiranjem odstranil iz okončine, postopek izolirane perfuzije pa končal.
Patients with contraindications to the use of vasopressor agents.
Bolniki, pri katerih je kontraindicirana uporaba vazopresornih učinkovin
3 years
60 minut.
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.
Raziskav o vplivu na razmnoževanje ali o kancerogenosti niso izvajali, ker je testiranje neustrezno glede na to, da je zdravilo
Severe pulmonary dysfunction.
trombocitopenijo in motnje strjevanja.
For administration by ILP Intraarterial use
Za uporabo v postopku izolirane perfuzije okončin intraarterijska uporaba
A homogeneous solution will be obtained by shaking gently.
Homogeno raztopino pripravimo tako, da jo narahlo stresamo.
Beromun 1 mg powder for infusion Tasonermin
Beromun 1 mg prašek za raztopino za infundiranje tasonermin
Sodium dihydrogen phosphate dihydrate Disodium phosphate dodecahydrate Human serum albumin.
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev dihidrogenfosfat dihidrat natrijev hidrogenfosfat dodekahidrat humani serumski albumin
The duration of the perfusion including melphalan should be 60 minutes.
Perfuzija, med katero dodamo melfalan, naj traja
The Summary of Product Characteristics for melphalan should be consulted for information on the interactions of melphalan.
Podatke o medsebojnem delovanju melfalana z drugimi zdravili je treba pregledati v povzetku glavnih značilnosti melfalana.
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.
3 mg, če je prizadeta roka, in 4 mg, če je prizadeta noga.
The perfusion should be terminated if the cumulative leakage into the systemic circulation is > 10%.
Če je skupno uhajanje > 10 %, moramo perfuzijo prekiniti.
Adult respiratory distress syndrome
sindrom dihalne stiske pri odraslem občasni:
Extremity necrosis, severe enough to warrant amputation
huda nekroza okončine pri kateri je potrebna amputacija
Patients with contraindications to radioactive tracer monitoring.
Bolniki, pri katerih je kontraindicirana uporaba antikoagulansov Bolniki, pri katerih je kontraindicirano spremljanje z radioaktivnim sledilom Bolniki, pri katerih je kontraindicirana hipertermija okončine
Pharmacokinetics in ILP
Farmakokinetika pri izolirani perfuziji okončine
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.
perfuzijske raztopine med 7,2 in 7,35, vbrizgamo zdravilo Beromun v obliki bolusa v arterijski vod obtoka.
Please refer to the Summary of Product Characteristics for melphalan.
Podatki so navedeni v Povzetku glavnih značilnosti melfalana.
Renal failure acute General disorders and administration site conditions Very common:
Splošne težave in spremembe na mestu aplikacije zelo pogosti:
Beromun and then melphalan are injected into this circuit, over a total of 90 minutes the affected limb will be exposed to Beromun.
Zdravilo Beromun in nato melfalan vbrizgajo v ta krogotok.
Cardiac failure
akutna ledvična okvara
Surgical resection of the tumour remnant should be undertaken whenever possible.
Če je le možno, preostanek tumorja kirurško odstranimo.
Arrhythmia
Odmerjanje
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.
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.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER (S) RESPONSIBLE FOR BATCH RELEASE
(IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
Batch
sepsa
As Beromun is always administered by experienced and qualified hospital doctors, accidental overdose is extremely unlikely.
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.
Please refer to the Summary of Product Characteristics for melphalan for information on overdose of melphalan.
Podatke o prevelikem odmerjanju melfalana preberite v povzetku glavnih značilnosti melfalana.
You will usually not receive a second ILP with Beromun.
Postopka izolirane perfuzije z zdravilom Beromun vam najbrž ne bodo ponovili.
The solution of the reconstituted product should be inspected visually for particulate matter prior to administration.
Pripravljeno raztopino je treba pred uporabo pregledati, da bi odkrili, ali ne vsebuje delcev.
Beromun 1 mg powder for solution for infusion
Beromun 1 mg prašek za raztopino za infundiranje
Adverse reactions have been ranked under headings of frequency using the following convention:
Tabelarični seznam neželenih učinkov Neželeni učinki so po pogostnosti razvrščeni v naslednje skupine:
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.
Med postopkom izolirane perfuzije in še sedem do deset dni zatem boste morali ostati v bolnišnici.
Hepatobiliary disorders Very common:
Infekcijske in parazitske bolezni pogosti:
Pregnancy and lactation (see section 4.6).
Sočasno zdravljenje s kardiotoksičnimi učikovinami (npr. antraciklini) Nosečnost in dojenje (glejte poglavje 4.6)
A number of therapeutic measures are routinely used during the ILP and in the immediate post-operative period.
Med izolirano perfuzijo okončine in neposredno po operaciji bolniku rutinsko dajemo več zdravil.
Please refer to the Summary of Product Characteristics for melphalan for details regarding incompatabilities with melphalan.
Podrobne podatke o inkompatibilnosti melfalana vsebuje Povzetek glavnih značilnosti melfalana.
No significant interactions have so far been noted, but caution should be exercised (see section 4.5).
je potrebna previdnost (glejte poglavje 4.5).
You may have to stay in an intensive care unit (ICU) directly after the ILP for a short time.
Takoj po postopku izolirane perfuzije boste lahko krajši čas na oddelku za intenzivno nego.
A recent history of, or active peptic ulcer.
Obstoječa aktivna peptična razjeda ali takšna razjeda v novejši anamnezi
Powder for solution for infusion (powder for infusion).
prašek za raztopino za infundiranje (prašek za infuzijo) Prašek je bel do sivo-bel.
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.
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.
Please refer to the Summary of Product Characteristics of melphalan prior to commencing an ILP procedure.
Preden boste začeli postopek izolirane perfuzije okončine, preberite Povzetek glavnih značilnosti melfalana.
No significant interactions have so far been noted, but caution should be exercised (see section 4.4).
je potrebna previdnost (glejte poglavje 4.4).
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
- 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;
Uncommon:
aritmija pogosti:
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL FOR BEROMUN
OVOJNINAH NALEPKA NA VIALI ZA BEROMUN
Vascular disorders Common:
Žilne bolezni pogosti:
How to store Beromun
Shranjevanje zdravila Beromun
Package size
Velikost pakiranja infundiranje
These measures will help protect environment.
Taki ukrepi pomagajo varovati okolje.
9 to < 16 16 to 23 > 23 to 34
9 do 16 16 do 23 23 do 34