natgillin/translations-raw huggingface dataset:
Do not use after the expiry date stated on the outer box and vial label.
Zdravila BeneFIX ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji škatli in oznaki viale.
Do not use BeneFIX if the solution is not clear or colourless.
149 Ne uporabljajte zdravila BeneFIX, če raztopina ni bistra in brezbarvna.
Do not store above 25ºC.
Ne shranjujte zdravila pri temperaturi nad 25 ºC.
BeneFIX must be stored continuously in a refrigerator at a temperature of 2°C to 8°C and must be used by the expiry date on the label.
Zdravilo BeneFIX mora stalno hraniti v hladilniku pri temperaturi med 2 °C in 8 °C) in ga morate porabiti do datuma izteka roka uporabnosti, ki je naveden na oznaki.
For the purpose of ambulatory use the product may be removed from such storage for one single period of maximum 1 month at room temperature (up to 25°C).
Za ambulantno uporabo smete vzeti zdravilo iz hladilnika za eno samo obdobje, ki ne sme biti daljše od 1 meseca, pri sobni temperaturi (do 25 ºC).
Use the reconstituted solution immediately or within 3 hours.
Uporabite rekonstituirano raztopino takoj, najpozneje pa v 3 urah.
contains nominally 250, 500, 1000 or 2000 IU of nonacog alfa.
Ena viala zdravila BeneFIX vsebuje nominalno 250, 500, 1. 000 ali 2. 000 i. e. nonakoga alfa. − Pomožne snovi so saharoza, glicin, L- histidin, polisorbat 80.
- After reconstitution with the supplied solvent (0.234% sodium chloride solution), each vial contains
Priložen je tudi vehikel (0, 234 - odstotna raztopina natrijevega klorida) za rekonstitucijo. − Po rekonstituciji s priloženim vehiklom (0, 234- odstotna raztopina natrijevega klorida) ena viala vsebuje 50, 100, 200 ali 400 i. e. / ml (glejte preglednico 1).
250 IU 500 IU 1000 IU 2000 IU
1. 000 i. e.
50 IU 100 IU 200 IU 400 IU
200 i. e.
• one vial of BeneFIX 250, 500 1000 or 2000 IU powder • one pre-filled syringe of solvent, 5 ml sterile 0.234% sodium chloride solution for injection for reconstitution, with one plunger rod • one sterile vial adapter reconstitution device • one sterile infusion set • two alcohol swabs • one plaster • one gauze pad
• eno vialo BeneFIX 250, 500, 1. 000 ali 2. 000 i. e. praška, • eno napolnjeno injekcijsko brizgo vehikla, 5 ml sterilne 0, 234- odstotne raztopine natrijevega klorida za injekcije za rekonstitucijo, z enim batom,
161 Manufacturer
Izdelovalec
België/ Belgique/ Belgien Luxembourg/ Luxemburg Wyeth Pharmaceuticals S. A. / N. V.
151 België/ Belgique/ Belgien Luxembourg/ Luxemburg Wyeth Pharmaceuticals S. A. / N. V.
Sverige Wyeth AB Tel: +46 8 470 3200 Fax: +46 8 730 0666
152 Sverige Wyeth AB Tel: +46 8 470 3200 Fax: +46 8 730 0666
The European Medicines Agency (EMEA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
Evropska agencija za zdravila (EMEA) bo vsako leto ponovno pregledala vse nove podatke, ki bodo na voljo in posodobila povzetek glavnih značilnosti zdravila, če bo potrebno.
163
153
Beromun is used in patients with soft tissue sarcoma (a type of cancer) of the limb (arm or leg), together with melphalan (an anticancer medicine), using a technique called ‘ isolated limb perfusion’ (ILP): both medicines are injected into the limb while the blood circulation in the limb is kept isolated (cut off) from the rest of the body.
Zdravilo Beromun se uporablja pri bolnikih s sarkomom mehkega tkiva (vrsto raka) okončin (roke ali noge) v kombinaciji z melfalanom (zdravilom proti raku), pri čemer se uporablja tehnika, imenovana „ izolirana perfuzija okončine “: obe zdravili se injicirata v okončino, pri čemer je krvni obtok v tej okončini izoliran (ločen) od preostalega telesa.
The blood circulation in the limb is then replaced by the ‘ perfusion ’ of a special liquid and the limb is warmed to a temperature of between 38 and 39°C.
Krvni obtok v okončini nato nadomesti „ perfuzija “ (pretok) posebne tekočine, pri čemer okončino ogrevamo na temperaturo med 38 in 39 °C.
The dose of melphalan depends on the size of the arm or leg.
Odmerek melfalana je odvisen od velikosti roke ali noge.
At the end of the 90-minute procedure, the medicines are flushed out of the limb using a suitable fluid.
Ob koncu tega 90- minutnega postopka se zdravili s primerno tekočino izpereta iz okončine.
The active substance in Beromun, tasonermin, is a copy of the human protein tumour necrosis factor alfa-1a (TNF α).
Zdravilna učinkovina zdravila Beromun, tasonermin, je kopija človeške beljakovine tumorje - nekrotizirajočega faktorja alfa- 1a (TNFα).
The exact way that TNF α works against certain types of cancer is not fully understood, but it is thought that it can kill tumour cells directly, as well as destroy the blood vessels supplying tumours and stimulate the immune system to attack them.
Natančen način delovanja TNFα proti določenim vrstam raka ni v celoti znan, vendar se domneva, da lahko neposredno ubija tumorske celice, uničuje krvne žile, ki dovajajo snovi v tumorje, ter spodbudi imunski sistem, da jih napade.
The active substance in Beromun, tasonermin, is produced by a method known as ‘ recombinant DNA technology’: it is made by bacteria that have received a gene (DNA), which makes them able to produce TNFα.
Zdravilno učinkovino v zdravilu Beromun, tasonermin, proizvajajo z metodo, znano kot „ tehnologija rekombinantne DNK “, pri kateri celica prejme gen (DNK), s katerim lahko tvori TNFα.
The independent reviewers agreed that 62% of the patients receiving Beromun and melphalan (90 out of 145) had a better outcome than predicted, since their limb was saved without surgery to remove the tumour or their tumour was removed without causing significant loss of function.
Neodvisni pregledovalci so se strinjali, da je imelo 62% bolnikov, ki so prejeli zdravilo Beromun in melfalan (90 bolnikov od 145), boljši izid od pričakovanega, saj je bila njihova okončina ohranjena, ne da bi bila izvedena operativna odstranitev tumorja, oziroma je bil tumor odstranjen, ne da bi to povzročilo bistveno zmanjšanje funkcionalnosti.
There were too few patients also receiving interferon-gamma to determine whether this improved the patients ’ outcome further.
Bolnikov, ki so prejemali tudi interferon gama, je bilo premalo, da bi lahko potrdili, ali je to pri bolnikih dodatno izboljšalo izid.
The Committee for Medicinal Products for Human Use (CHMP) decided that Beromun’ s benefits are greater than its risks 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 ILP.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Beromun 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 večje od z njim povezanih tveganj.
2/ 3 This summary was last updated in 04-2009.
2/ 3 Celotno javno poročilo o oceni zdravila (EPAR) za zdravilo Beromun je na voljo tukaj.
Invented name Strength
Zaščiteno ime
Powder and solvent for solution for infusion
Prašek in vehikel za raztopino za infundiranje
Powder: vial (glass) Solvent: ampoule (glass)
Prašek: viala (steklenica) Vehikel: ampula (steklenica)
1 mg Solvent:
1 mg Vehikel:
Beromun 1 mg/ 5 ml powder and solvent for solution for infusion
Beromun 1 mg/ 5 ml prašek in vehikel za raztopino za infundiranje
One vial contains 1 mg tasonermin (Tumor Necrosis Factor alfa-1a; TNFα -1a) exhibiting an activity of 3.0-6.0 x 107 IU.
Ena viala vsebuje 1 mg tasonermina (tumorje- nekrotizirajoči faktor alfa- 1a; TNFα- 1a) z aktivnostjo 3, 0 – 6, 0 x 107 i. e..
One ampoule solvent contains 5 ml 0.9% sodium chloride solution.
Ena ampula vehikla vsebuje 5 ml 0, 9% raztopine natrijevega klorida.
After reconstitution the strength is 0.2 mg/ ml.
Jakost pripravljene raztopine je 0, 2 mg/ ml.
Tasonermin is produced by recombinant DNA technology in E. coli.
Tasonermin je pridobljen s pomočjo tehnologije rekombinantne DNA iz E. coli.
Powder and solvent for solution for infusion (for isolated limb perfusion; ILP).
Prašek in vehikel za raztopino za infundiranje (za izolirano perfuzijo okončine).
The powder is white to off-white.
Prašek je bel do sivo- bel.
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).
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.
4 mg total dose by isolated limb perfusion
Zgornja okončina: skupni odmerek po 3 mg z izolirano perfuzijo okončine Spodnja okončina: skupni odmerek po 4 mg z izolirano perfuzijo okončine
Melphalan dosage 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, Benckhuysen C, Braat RP, van Slooten EA, Olthius GAA.
905-910.), to a maximum dose of 150 mg.
905- 910.), do največjega odmerka, ki je 150 mg.
13 mg/ litre perfused upper limb volume 10 mg/ litre perfused lower limb volume
13 mg/ l volumna perfundirane zgornje okončine 10 mg/ l volumna perfundirane spodnje okončine
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 smejo izvajati samo kirurške ekipe, ki imajo izkušnje z zdravljenjem sarkoma na okončinah in s postopkom izolirane perfuzije okončin, in sicer v specializiranih centrih z oddelkom za intenzivno zdravljenje in opremo za neprekinjeno spremljanje uhajanja zdravila v sistemski obtok.
Beromun should be administered by mild hyperthermic isolated limb perfusion.
Za dajanje Beromuna moramo uporabiti blago hipertermični postopek za izolirano perfuzijo okončine.
The perfusion circuit (roller pump, oxygenator with integrated reservoir, heat exchanger, connecting tubing) should be prepared prior to surgery and primed with 700 to 800 ml of perfusate, with haematocrit of 0.25 to 0.30.
Perfuzijski sistem (valjčna črpalka, oksigenator z vgrajenim rezervoarjem, toplotni izmenjevalec, povezovalne cevke) je treba pripraviti pred kirurškim posegom in ga napolniti s 700 do 800 ml perfuzijske raztopine, s hematokritom 0, 25 do 0, 30.
2 Perfusion level should be chosen to adequately encompass affected tissue (external iliac, common femoral, femoro-popliteal, popliteal, axillary and brachial being accepted routes) and catheters introduced.
2 Določiti je treba tolikšno raven perfuzije, da bo ustrezno zajela prizadeto tkivo (sprejete poti so zunanja iliakalna, skupna femoralna, femoro- poplitealna, poplitealna, aksilarna in brahialna), in vstaviti katetre.
After connection of the limb to the isolated circuit, flow rate should be adjusted to 35 to 40 ml/ litre limb volume/ minute and leakage from limb to systemic circulation checked using a radioactive tracer technique (see section 4.4).
Ko priključimo okončino na izolirani krogotok, moramo hitrost pretoka naravnati na 35 do 40 ml/ l volumna okončine/ minuto in preveriti morebitno uhajanje zdravilne učinkovine iz okončine v sistemski obtok z radioaktivnim sledilcem (glejte poglavje 4. 4).
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%.
Včasih je treba prilagoditi hitrost pretoka in zažemko, tako da je uhajanje iz perfuzijskega v sistemski obtok stabilno (da sistemska raven radioaktivnosti doseže plato) in ne prekorači 10%.
Beromun should only be administered if leakage is less than 10%.
Beromun smemo dajati samo, če je uhajanje manjše od 10%.
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.
Ko je temperatura v distalnem podkožnem tkivu okončine nad 38 °C (toda ne višja od 39 °C) in pH perfuzijske raztopine med 7, 2 in 7, 35, vbrizgamo Beromun v obliki bolusa v arterijski vod obtoka.
After 30 minutes perfusion of Beromun alone, melphalan should be added as a bolus into the reservoir of the circuit, or slowly into the arterial line of the circuit.
Po 30 minutah perfuzije s samim Beromunom je treba dodati melfalan v obliki bolusa v rezervoar krogotoka ali počasi v arterijski vod obtoka.
The temperature should then be increased to > 39°C (but not exceeding 40°C) in two different sites of measurement in the tumour area.
Nato temperaturo povečamo do > 39 °C (toda ne na več kot 40 °C) na dveh različnih merilnih mestih v predelu tumorja.
The duration of the perfusion including melphalan should be 60 minutes.
Perfuzija, med katero dodamo melfalan, naj traja 60 minut.
At the end of the perfusion, the perfusate should be collected into the reservoir while washout fluid is added simultaneously to the circuit and circulated at the same flow rate of 35 to 40 ml/ litre limb volume/ minute.
Ob koncu perfuzije zberemo perfuzijsko raztopino v rezervoar in hkrati dodamo v krogotok tekočino za izpiranje, ki naj kroži z enako hitrostjo, 35 do 40 ml/ l volumna okončine/ minuto.
Washout should be continued until the colour of the perfusate is clear (pink, transparent; see section 4.4).
Izpirati je treba, dokler ne postane perfuzijska raztopina čista (rožnata, prozorna; glejte poglavje 4. 4).
Safety and efficacy in children under the age of 16 has not been established.
Varnost in učinkovitost nista raziskani pri otrocih, mlajših od 16 let.
Contraindications to Beromun isolated limb perfusion (ILP), subdivided by components of the procedure, are:
Kontraindikacije za izolirano perfuzijo okončine z Beromunom, navedene po posameznih delih postopka, so:
Contraindications to Beromun:
Kontraindikacije za Beromun:
Hypersensitivity to the active substance or to any of the excipients.
Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov
Significant cardiovascular disease, e. g. congestive heart failure (New York Heart Association Class II, III or IV), severe angina pectoris, cardiac arrhythmias, myocardial infarction within a 3 month period prior to treatment, venous thrombosis, occlusive peripheral arterial disease, recent pulmonary embolism.
Hujša srčnožilna bolezen, npr. zastojno srčno popuščanje (II., III. ali IV. razred po klasifikaciji New York Heart Association), huda angina pektoris, srčne aritmije, miokardni infarkt v obdobju 3 mesecev pred posegom, venska tromboza, okluzivna periferna arterijska bolezen, nedavna pljučna embolija
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.
Hujše hematološke motnje, npr. levkociti < 2, 5 x 109/ l, hemoglobin < 9 g/ dl, trombociti < 60 x 109/ l, hemoragična diateza ali aktivna krvavitev
Significant renal dysfunction, e. g. nephrotic syndrome, serum creatinine > 150 µmol/ l, or creatinine clearance of < 50 ml/ minute.
Hujše motnje ledvičnega delovanja, npr. nefrotični sindrom, serumski kreatinin > 150 µmol/ l ali kreatininski očistek < 50 ml/ min
3 Significant hepatic dysfunction, e. g. > 2 x upper limits of normal levels of aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase; or bilirubin levels > 1.25 x upper limits of normal.
Hujše motnje jetrnega delovanja, npr. > 2- kratna zgornja meja normalnih ravni aspartat- aminotransferaze, alanin- aminotransferaze ali alkalne fosfataze; ali raven bilirubina > 1, 25- kratna zgornja meja normalne ravni
Hypercalcaemia > 12 mg/ dl (2.99 mmol/ l).
Hiperkalcemija > 12 mg/ dl (2, 99 mmol/ l)
Patients with contraindications to the use of vasopressor substances.
3 Bolniki, pri katerih je kontraindicirana uporaba vazopresornih učinkovin
Simultaneous treatment with cardiotoxic substances (eg anthracyclines).
Sočasno zdravljenje s kardiotoksičnimi učikovinami (npr. antraciklini)
Use in pregnancy and lactation (see section 4.6).
Nosečnost in dojenje (glejte poglavje 4. 6)
Please refer to SPC for melphalan.
Podatki so navedeni v Povzetku glavnih značilnosti melfalana.
Patients with contra-indications to the use of vasopressor agents.
Bolniki, pri katerih je kontraindicirana uporaba vazopresornih učinkovin
Patients with contraindications to radioactive tracer monitoring.
Bolniki, pri katerih je kontraindicirano spremljanje z radioaktivnim sledilom
Patients with contraindications to limb hyperthermia.
Bolniki, pri katerih je kontraindicirana hipertermija okončine
Use in pregnancy and lactation.
Nosečnost in dojenje
Isolated limb perfusion 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 smejo izvajati samo kirurške ekipe, ki imajo izkušnje z zdravljenjem sarkoma na okončinah in s postopkom izolirane perfuzije okončin, in sicer v specializiranih centrih z oddelkom za takojšnje intenzivno zdravljenje in opremo za neprekinjeno spremljanje uhajanja zdravila v sistemski obtok.
Beromun must not be administered systemically.
Beromuna ne smemo dajati sistemsko.
Please refer to the SPC of melphalan prior to commencing an ILP procedure.
Preden boste začeli postopek izolirane perfuzije okončine, preberite Povzetek glavnih značilnosti melfalana.
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.
4 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 Beromuna, lahko preprečimo s paracetamolom (peroralno ali v obliki svečk) ali drugim analgetikom oz. antipiretikom pred posegom.
This is to ensure optimal haemodynamic conditions and ensure a high urinary output, especially after the perfusion, to allow for rapid clearance of any residual Beromun.
S tem zagotovimo optimalne hemodinamične razmere in povečamo izločanje seča, zlasti po perfuziji, da bi se preostanek Beromuna hitro izločil.
Additional resuscitation fluids (crystalloid and colloid solutions) should be available for volume expansion in case of a significant fall in blood pressure.
Pripravljene moramo imeti tekočine za povečanje volumna (kristaloidne in
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.
In order to minimise the risk of leakage of the perfusate into the systemic circulation, the perfusion flow rate should not exceed 40 ml/ litre limb volume/ minute.
Da bi nevarnost uhajanja perfuzijske raztopine v sistemski obtok, kolikor je možno zmanjšali, hitrost pretoka perfuzijske tekočine ne sme prekoračiti 40 ml/ l volumna okončine/ minuto.
Potential leakage should be measured by radioactively labelled albumin or erythrocytes injected into the perfusion circuit, with appropriate measures for continuous monitoring of radioactivity leakage into the systemic circulation (Hoekstra HJ, Naujocks T, Schraffordt Koops H, Beekhuis H, van Groningen a Stuling R, ter Veen H, et. al..
Morebitno uhajanje moramo nadzorovati z radioaktivno označenim albuminom ali eritrociti, ki jih vbrizgamo v perfuzijski krogotok, ob ustreznem neprekinjenem spremljanju uhajanja radioaktivnosti v sistemski obtok (Hoekstra HJ, Naujocks T, Schraffordt Koops H, Beekhuis H, van Groningen a Stuling R, ter Veen H, et. al..
Adjustment of flow rate and tourniquet may be required to ensure leakage is stable (systemic level of radioactivity has reached a plateau) and does not exceed 10%.
Včasih moramo prilagajati hitrost pretoka in zažemko, da bi bilo uhajanje stabilno (da sistemska raven radioaktivnosti doseže plato) in ne bi prekoračilo 10%.
The perfusion should be terminated if the cumulative leakage into the systemic circulation is > 10%.
Če je skupno uhajanje > 10%, moramo perfuzijo prekiniti.
The maximum tolerated dose (MTD) of Beromun for ILP is 4 mg, which is 10 times the systemic MTD.
Največji odmerek Beromuna za izolirano perfuzijo okončine, ki ga bolniki še prenašajo, je 4 mg, kar je 10- krat več kot največji, še prenosljivi sistemski odmerek.
Therefore, whenever there is significant systemic leakage of Beromun, serious undesirable effects are to be expected.
Zato lahko večje uhajanje Beromuna v sistemski obtok povzroči resne neželene učinke.
Doses of up to 6 mg of other TNFα preparations have been administered via ILP, but this dose was found to be unacceptable in terms of loco-regional toxicity.
Za izolirano perfuzijo okončine so že uporabili do 6- miligramske odmerke drugih pripravkov TNFα, vendar se je pokazalo, da so tako veliki odmerki zaradi lokalnoregionalne toksičnosti nesprejemljivi.
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 znaki sistemske toksičnosti, npr. vročina, srčne aritmije, šok ali hipotenzija ali sindrom dihalne stiske, moramo uvesti splošne podporne ukrepe in bolnika takoj premestiti na oddelek za intenzivno zdravljenje.
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 Beromun, so poročali o utesnitvenem sindromu (kompartment sindromu), za katerega so bili značilni bolečina, oteklina in nevrološki simptomi ter poškodba mišic perfundirane okončine.
1.
Pri klinični diagnozi utesnitvenega sindroma je treba presoditi o naslednjih terapevtskih ukrepih:
Forced diuresis and alkalinisation of the urine, if a muscle damage occurs with increased myoglobin levels in plasma and urine.
1. fasciotomiji (prerezanju mišičnih ovojnic) vseh mišičnih kompartmentov v prizadeti okončini; 2. forsirana diureza in alkalizacija seča, če so poškodovane mišice in povečane ravni mioglobina v plazmi in seču.
No formal interaction studies have been performed with Beromun.
Formalnih raziskav o interakcijah z Beromunom niso izvajali.
Co-administration, other than in the standard regimen with melphalan, is not recommended.
Sočasne uporabe z drugimi zdravili, razen standardnega režima zdravljenja z melfalanom, ne priporočamo.
Beromun has been co-administered with interferon-gamma in the ILP setting but no added value has been demonstrated.
5 Beromun so v sklopu izolirane perfuzije okončine že dajali sočasno z interferonom gama, toda pokazalo se je, da ne prinaša dodatne koristi.