natgillin/translations-raw huggingface dataset:
BEROMUN is supplied as a powder and solvent for solution for infusion, in cartons of four glass vials, each containing 1 mg (3.0-6.0 x 107 IU) of the active substance tasonermin, together with four glass ampoules containing sterile sodium chloride solution (physiological saline) for dissolving the contents of the glass vials.
BEROMUN je kot prašek in vehikel za raztopino in infundiranje na voljo v ovojnini s štirimi steklenimi vialami po 1 mg (3, 0 do 6, 0 x 107 i. e.) zdravilne učinkovine tasonermina; priložene pa so štiri steklene ampule s sterilno raztopino natrijevega klorida (fiziološko solno raztopino) za raztapljanje vsebine steklenih vial.
Beromun is for single use only.
Beromun je samo za enkratno uporabo.
BEROMUN has been prescribed and will be administered by your doctor, together with the anti- tumour agent melphalan, for the treatment of soft tissue sarcoma of the arms and legs.
BEROMUN vam je predpisal zdravnik, ki vam bo zdravilo tudi dajal, hkrati s protitumorsko učinkovino melfalan, za zdravljenje sarkoma v mehkem tkivu roke ali noge.
Treatment with BEROMUN and melphalan is intended to reduce the size of your tumour, which has been considered by your doctor to be either inoperable or only operable with the result of severe disability.
Namen zdravljenja z BEROMUNOM in melfalanom je zmanjšati tumor, ki ga po zdravnikovi presoji ni možno kirurško odstraniti ali pa bi njegova odstranitev imela za posledico hudo invalidnost.
Reducing the size of the tumour will allow for an easier surgical removal of the tumour, preventing severe damage to the surrounding healthy tissue, nerves and blood vessels, and will delay or possibly prevent the need for arm or leg amputation.
Z zmanjšanjem tumorja olajšamo njegovo kirurško odstranitev, preprečimo hude poškodbe okolnega zdravega tkiva, živcev in krvnih žil ter odložimo amputacijo roke ali noge ali jo preprečimo.
INFORMATION BEFORE USE
KAJ MORATE VEDETI, PREDEN BOSTE PREJELI BEROMUN
When should BEROMUN not be used?
BEROMUNA ne boste prejemali:
BEROMUN will not be prescribed and given by your doctor:
Zdravnik vam BEROMUNA ne bo predpisal niti dajal:
- if you are hypersensitive (allergic) to tasonermin, or any of the other ingredients of BEROMUN
- če ste preobčutljivi za (alergični na) tasonermin ali katerokoli sestavino BEROMUNA;
- if you suffer from heart failure, severe angina, heart beat disturbances or have suffered a heart
- če imate srčno popuščanje, hudo angino pektoris, motnje srčnega utripa ali ste imeli srčni napad v
If you have other circulatory diseases, your doctor might also not prescribe BEROMUN
obdobju treh mesecev pred zdravljenjem z BEROMUNOM; zdravnik vam ga verjetno ne bo predpisal, če imate druge bolezni obtočil;
- if you suffer from severe lung disorder
- če imate hudo pljučno bolezen;
- if you have, or have recently had, a stomach ulcer
- če imate ali ste pred kratkim imeli želodčno razjedo;
- if your amounts of various types of blood cells and blood components are too low
- če je pri vas količina različnih vrst krvnih celic in krvnih sestavin premajhna;
- if you suffer from severe liver or kidney disease
- če imate hudo jetrno ali ledvično bolezen;
- if you are unable to take vasopressors (medicines which are used to increase low blood
- če ne smete prejeti vazopresornih zdravil (s katerimi povečamo nizek krvni tlak);
- if you are unable to take anticoagulants (medicines which are used to prevent blood clotting)
- če ne smete prejeti antikoagulansov (zdravil, s katerimi preprečujemo nastanek krvnih strdkov);
- if you are unable to take radioactive tracers (radioactively labelled medicines which are used to
- če ne smete prejeti radioaktivnih sledil (radioaktivno označenih zdravil za nadzor uhajanja zdravila iz
analyse leakage; see Important information about BEROMUN, below)
izoliranega predela; glejte Pomembne informacije o BEROMUNU);
- if you are simultaneously being treated with medicines which are toxic to the heart (eg
- če se sočasno zdravite z zdravili, ki lahko toksično delujejo na srce (npr. antraciklini);
- if you have raised levels of calcium in your blood
- če imate povečano raven kalcija v krvi;
- if you are suffering from certain infections which do not respond to antibiotics
- če imate določene okužbe, ki se ne odzivajo na antibiotike;
- if you are suffering from severe swelling of the affected arm or leg due to local fluid build-up,
- če je vaša prizadeta roka ali noga močno otečena zaradi nabiranja tekočine v prizadetem predelu ali se
or severe fluid build-up in the abdomen
nabira veliko tekočine v trebušni votlini;
- if you are suffering from widespread or severe wounds, ulcers or sores on your affected arm or
- če imate rane na veliki površini ali hude rane, razjede ali vnetje na prizadeti roki ali nogi;
You must not breast feed for at least seven
- če ste noseči ali nosečnost načrtujete; po zdravljenju z BEROMUNOM najmanj sedem dni ne smete
days after receiving BEROMUN
dojiti.
Important information about BEROMUN:
Pomembne informacije o BEROMUNU:
BEROMUN will be administered to you by the technique of isolated limb perfusion (ILP) which ensures that BEROMUN is kept within the affected arm or leg and does not reach the main part of your body.
BEROMUN boste prejeli s tehniko izolirane perfuzije okončine, ki zagotavlja, da ostane zdravilo v prizadeti roki ali nogi in se ne razširi po telesu.
If BEROMUN does reach the main part of your body this is known as systemic leakage.
Če se BEROMUN razširi v telo, pravimo, da je prišlo do sistemskega uhajanja.
It is important to realise that systemic leakage can be dangerous because BEROMUN can have undesirable side-effects on the main organs of the body.
Pomembno je vedeti, da je lahko sistemsko uhajanje nevarno, ker lahko ima BEROMUN neželene učinke na glavne telesne organe.
BEROMUN will therefore be administered to you by a doctor who is experienced and skilled in the technique of ILP.
BEROMUN vam bo dajal izkušen zdravnik, ki je izurjen v uporabi tehnike izolirane perfuzije okončine.
He or she will have the correct facilities and equipment available to ensure that the administered BEROMUN stays in your affected arm or leg and does not reach the main part of your body.
Uporabil bo ustrezno opremo in instrumente, s katerimi bo zagotovil, da BEROMUN ne bo uhajal iz prizadete roke ali noge v druge telesne dele.
He or she will also have the correct facilities and equipment available to treat you if BEROMUN does unintentionally reach the main part of your body.
Na voljo bo imel tudi ustrezno opremo in instrumente za potrebno zdravljenje, če bi BEROMUN nenamerno ušel v telo.
Careful monitoring of your blood pressure and circulation will be performed during the ILP and for a short time afterwards.
Med izolirano perfuzijo okončine in krajši čas po njej bodo skrbno spremljali vaš krvni tlak in krvni obtok.
As administration of BEROMUN requires a surgical procedure (ILP) taking place under general anaesthetic, and is associated with side-effects (see below; Possible side effects), you may require a short period of stay in an intensive care unit (ICU) directly after the ILP.
Ker je za dajanje BEROMUNA potreben kirurški poseg v splošni anesteziji in lahko ima neželene učinke (glejte Možne neželene učinke), boste takoj po posegu morda morali krajši čas ostati na oddelku za intenzivno zdravljenje.
In addition, due to the nature of the ILP technique, you will anyway be required to stay in hospital for about seven to ten days after BEROMUN administration, during which time you will be closely monitored for any undesirable side-effects of BEROMUN.
V tem času vas bodo skrbno nadzorovali, da bi odkrili morebitne neželene učinke BEROMUNA.
Particular consideration will be given to the onset of muscle damage including pain, swelling, as well as neurological symptoms at the perfused limb, also known as “ compartment syndrome”.
Posebno pozorni bodo na poškodbe mišic, bolečino in otekanje, ter nevrološke simptome v zdravljeni okončini, t. i. utesnitveni sindrom.
This condition, which has been observed in isolated cases after Beromun administration, may develop within the first three days after ILP.
Ta sindrom, ki so ga zasledili pri posameznih bolnikih po dajanju BEROMUNA, se lahko razvije prve tri dni po izolirani perfuziji okončine.
In case a compartment syndrome has been diagnosed, your physician will provide you the adequate treatment.
Če se razvije, vam bo zdravnik predpisal ustrezno zdravljenje.
22 Pregnancy If you are pregnant you should inform your doctor who will then not prescribe BEROMUN for you.
Nosečnost Če ste noseči, morate o tem obvestiti zdravnika, ki vam v tem primeru ne bo predpisal BEROMUNA.
Breast-feeding If you are breast-feeding you must not breast-feed your child for at least seven days after receiving treatment with BEROMUN.
Dojenje Če dojite, otroka ne smete dojiti najmanj sedem dni po zdravljenju z BEROMUNOM.
Important information about some of the ingredients of BEROMUN:
22 Pomembne informacije o nekaterih sestavinah BEROMUNA:
If you have ever had an allergic reaction to human serum albumin you should inform your doctor who will then not prescribe BEROMUN for you.
Če ste v preteklosti že imeli preobčutljivostno reakcijo na humani serumski albumin, morata obvestiti zdravnika, ki vam v tem primeru ne bo predpisal BEROMUNA.
Please inform your doctor if you are taking or have recently taken any other medicines, even those not prescribed.
Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
BEROMUN will be administered to you by the technique of isolated limb perfusion (ILP) which requires that you are also given several other medicines by your doctor.
BEROMUN boste prejeli s tehniko izolirane perfuzije okončine, ob kateri vam bo zdravnik predpisal tudi več drugih zdravil.
These include the anti-tumour agent melphalan, medicines to render you unconscious during ILP, pain killers, fever-reducing medicines, medicines to control your blood pressure and circulation, and medicines such as blood anticoagulants to allow the ILP technique to function correctly.
To so protitumorsko zdravilo melfalan, zdravila, zaradi katerih se posega ne boste zavedali, zdravila proti bolečinam, proti vročini, za uravnavanje krvnega tlaka in krvnega obtoka ter proti strjevanju krvi, ki so potrebna za pravilno izvajanje izolirane perfuzije okončine.
Your doctor is aware of these required medicines and will be directly responsible for their administration.
Zdravnik, ki vas bo zdravil, ve, da so dodatna zdravila potrebna in bo neposredno odgovoren za njihovo dajanje.
HOW IS BEROMUN ADMINISTERED?
KAKO UPORABLJATI BEROMUN
Prior to use your doctor will dissolve BEROMUN in the supplied solution of sodium chloride (saline) and the resulting solution will be administered into an artery in your affected arm or leg by the technique of isolated limb perfusion (ILP), together with the anti-tumour agent melphalan.
Zdravnik bo pred uporabo BEROMUN raztopil v priloženi raztopini natrijevega klorida (solni raztopini) in vam pripravljeno raztopino vbrizgal v arterijo prizadete roke ali noge s tehniko izolirane perfuzije okončine, hkrati s protitumorskim zdravilom melfalanom.
This will occur whilst you are unconscious, under the influence of a general anaesthetic.
To bo storil, ko boste nezavestni, pod vplivom splošnega anestetika.
BEROMUN will be administered by your doctor by the technique of isolated limb perfusion (ILP).
BEROMUN bo zdravnik vnesel s tehniko izolirane perfuzije okončine.
A dose of either 3 mg (if the affected limb is your arm) or 4 mg (if the affected limb is your leg) of BEROMUN will be administered by ILP for an initial period of 30 minutes.
Prvih 30 minut vam bo vnesel odmerek BEROMUNA po 3 mg (če je prizadeta roka) ali 4 mg (če je prizadeta noga).
Then a dose of not more than 150 mg of melphalan will be added to the ILP circuit and the ILP continued for a further 60 minutes.
Nato bo v krogotok dodal odmerek melfalana po največ 150 mg in postopek izolirane perfuzije nadaljeval še 60 minut.
In this way your affected limb will be exposed to BEROMUN for a total of 90 minutes.
Na ta način bo prizadeta okončina skupno izpostavljena učinku BEROMUNA 90 minut.
BEROMUN, together with melphalan, is given in your affected limb via a catheter in the main artery while the blood is drained via another catheter in the main vein.
BEEROMUN in melfalan bo zdravnik vbrizgal v prizadeto okončino skozi kateter v glavni arteriji, kri pa izpuščal po drugem katetru v glavni veni.
The blood is supplied with oxygen by a heart and lung machine and then pumped back into the artery in your affected limb.
Kri v aparatu srce- pljuča sprejme kisik, nato jo črpalka ponovno črpa v arterijo prizadete okončine.
In this way, all the tumour cells in your limb can be exposed to a very high dose of the medicines for one and a half hours, providing the best possible anti-tumour effect.
Tako so vse tumorske celice v prizadeti okončini izpostavljene zelo velikemu odmerku zdravil eno uro in pol in protitumorski učinek je takrat največji.
To stop the blood containing a high dose of BEROMUN and melphalan from flowing into the rest of your body, the blood flow to and from your affected limb will be stopped using a tourniquet during the operation.
Da bi preprečili odtekanje krvi, ki vsebuje velik odmerek BEROMUNA in melfalana v druge dele telesa, med postopkom ustavijo z zažemko dotok krvi v prizadeto okončino in iz nje.
At the end of the ILP your limb will be washed out with a suitable fluid to remove all the BEROMUN and melphalan from your limb.
Ob koncu izolirane perfuzije bodo zdravljeno okončino izprali z ustrezno tekočino, da bi iz nje odstranili ves BEROMUN in melfalan.
This will further ensure that very little, if any, goes into your bodily circulation.
Ta postopek zagotovi, da v telesni obtok prehaja zelo malo ali pa sploh nič zdravila.
You will usually not receive a second ILP with BEROMUN, and if you do this will not be until at least six weeks after your first ILP.
Če ga bodo, to ne bo prej kot najmanj šest tednov po prvi perfuziji.
What will happen if you receive an overdose or suffer systemic leakage?
Kaj se lahko zgodi ob prejetju prevelikega odmerka BEROMUNA ali ob njegovem sistemskem uhajanju?
As BEROMUN is always administered by experienced and qualified hospital doctors, accidental overdose is extremely unlikely.
Ker uporabljajo BEROMUN le izkušeni zdravniki, usposobljeni za njegovo uporabo, je nenameren vnos prevelikega odmerka malo verjeten.
However, should this occur, your doctor will immediately wash out your affected limb to remove the BEROMUN, using an appropriate solution, and the ILP will be stopped.
Za izpiranje bo uporabil ustrezno raztopino in postopek perfuzije končal.
23 During the ILP your doctor will closely watch and control the amount of BEROMUN which reaches the main part of your body.
Med izolirano perfuzijo okončine bo zdravnik natančno nadzoroval količino BEROMUNA, ki uhaja v druge telesne dele.
If more than 10% of the BEROMUN reaches the main part of your body (this is known as systemic leakage) similar measures as described for dealing with overdose will be carried out by your doctor.
Če bo vanje ušlo več kot 10% BEROMUNA (temu pravimo sistemsko uhajanje), bo izvedel podobne ukrepe kot pri vnosu prevelikega odmerka.
In the unlikely event that your doctor believes you have suffered, or might suffer, dangerous side- effects due either to overdose or systemic leakage, you will be immediately transferred to an intensive care unit (ICU) within the hospital, where your doctor can more closely monitor you and prescribe suitable treatment to deal with any dangerous side-effects which have developed.
Če bo zdravnik menil, da so se ali bi se lahko pojavili nevarni neželeni učinki zaradi prevelikega odmerka ali sistemskega uhajanja, kar je redko, vas bo nemudoma premestil na oddelek za intenzivno zdravljenje v bolnišnici, kjer lahko vaše stanje natančneje spremlja, in vam predpisal ustrezno zdravljenje, potrebno zaradi nevarnih neželenih učinkov.
You must be aware that the administration of BEROMUN together with melphalan by isolated limb perfusion (ILP) will cause side-effects.
23 Vedeti morate, da se neželeni učinki pojavljajo pri dajanju BEROMUNA hkrati z melfalanom pri izolirani perfuziji okončine.
Some of these side-effects will be caused by BEROMUN, some by melphalan and some by the ILP technique.
Nekateri od njih so povezani z BEROMUNOM, nekateri z melfalanom, nekateri pa s samo tehniko izolirane perfuzije okončine.
Some of the side-effects may be caused by a combination of these three things.
Neželeni učinki so lahko tudi skupna posledica kombinacije vseh treh.
In rare cases some of these side-effects could be serious, particularly if BEROMUN reaches the main part of your body (systemic leakage; see below).
Redko so neželeni učinki lahko tudi resni, zlasti če BEROMUN prehaja v druge dele telesa (sistemsko uhajanje; glejte nadaljnje besedilo).
Your doctor will discuss all these possibilities with you and explain the risks and benefits of BEROMUN treatment.
Zdravnik se bo o tem z vami pogovoril in vam pojasnil nevarnost in koristi zdravljenja z BEROMUNOM.
Side effects independent of seriousness have been listed under groups of frequency.
Neželeni učinki so neodvisno od resnosti razvršeni v skupine po pogostnosti.
The following classification is being used:
Uporabljena je naslednja klasifikacija:
- very common(ly) 10%+, (more than 1 per 10);
- zelo pogosti 10% +, (več kot 1 na 10);
- common(ly) > 1% and < 10%, (less than 1 per 10 but more than 1 per 100);
- pogosti > 1% in < 10%, (manj kot 1 na 10, ampak več kot 1 na 100);
- uncommon(ly) 0.1% to 1%, (less than 1 per 100 but more than 1 per 1000).
- občasni 0, 1% do 1%, (manj kot 1 na 100, ampak več kot 1 na 1000).
Immediately after the administration of BEROMUN and melphalan, after you have regained consciousness from the isolated limb perfusion (ILP), you may experience in your affected arm or leg the following effects:
Takoj po dajanju BEROMUNA in melfalana, ko boste po izolirani perfuziji okončine spet pri zavesti, se lahko v vaši prizadeti roki ali nogi pojavijo naslednji učinki:
The following side effects have been very commonly reported:
O naslednjih neželenih učinkih so poročali zelo pogosto:
- pain and swelling, or infections, in the affected arm or leg
- bolečina in oteklina, ali okužba v prizadeti roki ali nogi,
- damage to nerves of the affected arm or leg
- poškodba živcev v prizadeti roki ali nogi,
- blistering of the skin, sometimes resulting in local wound infections
- mehurji na koži, včasih kot posledica lokalnih okužb rane,
- fluid build-up in the affected arm or leg
- nabiranje tekočine v prizadeti roki ali nogi.
The following side effects have been observed commonly:
Naslednje neželene učinke so zasledili pogosto:
- blood clot formation in the artery or vein of the affected arm or leg
- nastanek krvnega strdka v arteriji ali veni prizadete roke ali noge,
- temporary loss of finger or toe nails of the affected arm or leg
- začasna izguba nohtov na prizadeti roki ali nogi,
- compartment syndrome*, characterised by pain, swelling and neurological symptoms, as well as
- utesnitveni sindrom *, za katerega so značilni bolečina, oteklina in nevrološki simptomi ter poškodba
muscle damage in the affected arm or leg
mišice v prizadeti roki ali nogi,
- hypersensitivity reaction*
- preobčutljivostna reakcija *.
In approximately 2% of cases, BEROMUN may cause tissue damage in your affected arm or leg which is severe enough to require amputation.
V približno 2% primerov lahko BEROMUN tako močno poškoduje tkivo prizadete roke ali noge, da je potrebna amputacija.
Immediately after the administration of BEROMUN, after you have regained consciousness from the isolated limb perfusion (ILP), you may experience the following general effects which will have been caused by a small scale leakage of BEROMUN into the main part of your body (systemic leakage):
Takoj po dajanju BEROMUNA, ko se po izolirani perfuziji okončine zbudite, so lahko prisotni naslednji splošni učinki, ki so posledica manjšega uhajanja BEROMUNA v druge telesne dele (sistemskega uhajanja):
- fever
- vročina,
- disturbances in your heart beat
- motnje srčnega ritma,
- nausea, loss of appetite, and possibly vomiting
- slabost, izguba teka in možnost bruhanja,
- chills
- mrzlica,
- fatigue
oslabelost,
- liver toxicity resulting in temporary functional changes
- toksičen učinek na jetra, zaradi katerega je začasno spremenjeno njihovo delovanje,
- increased likelihood of bacterial infections
- večja verjetnost bakterijskih okužb.
The following side effects have been observed commonly:
Naslednje neželene učinke so zasledili pogosto: motnje delovanja srca in nizek krvni tlak (šok),
- disturbances in your heart function and low blood pressure (shock)
- glavoboli in drugi gripozni simptomi (npr. mišična bolečina, nočno znojenje),
- protein in your urine
- beljakovine v seču,
- blood poisoning*
- zastrupitev krvi *,
- breathing problems
- težave z dihanjem,
- constipation, or possibly diarrhoea
- zaprtje ali možnost driske,
- reductions in levels of certain blood components
- zmanjšanje ravni določenih krvnih sestavin,
- nerve damage
- poškodbe živcev,
The following side effect has been observed uncommonly:
24 Naslednji neželeni učinek so zasledili občasno:
- kidney toxicity resulting in temporary functional changes
- toksični učinek na ledvice, zaradi katerega je začasno spremenjeno njihovo delovanje.
*Due to the low patient number having used BEROMUN it is difficult for these side effects to calculate the frequency.
* Zaradi majhnega števila bolnikov, ki so prejeli BEROMUN, je pogostnost teh neželenih učinkov težko izračunati.
However, they are assumed to occur commonly.
Vendar se le ti predvidoma pojavljajo pogosto.
In addition, it is important to realise that BEROMUN and melphalan treatment can result in the above general side-effects becoming more severe and serious.
Poleg tega je pomembno, da veste, da se lahko zgoraj našteti splošni neželeni učinki zdravljenja z BEROMUNOM in melfalanom pojavijo tudi v hujši in resnejši obliki.
This is more likely to occur when there is a higher level (greater than 10% of the administered dose) of BEROMUN and melphalan systemic leakage.
Možnost, da se bodo pojavili hujši neželeni učinki, je večja pri večjem uhajanju BEROMUNA in melfalana (več kot 10% vnesenega odmerka).
If your doctor notices that you are suffering from, or are likely to suffer from, any of these severe side- effects described above, you will be immediately transferred to an intensive care unit (ICU) within the hospital, where your doctor can more closely monitor you and prescribe suitable treatment to deal with any dangerous side-effects which have developed.
Če zdravnik opazi, da imate hudo obliko katerega od naštetih neželeni učinkov, ali je možno, da se bo razvil, vas bo nemudoma premestil na oddelek za intenzivno zdravljenje v bolnišnici, kjer bo lahko vaše stanje natančneje spremljal in vam predpisal ustrezno zdravljenje, potrebno zaradi resnih neželenih učinkov.
If you feel any of the above side-effects are severe, but have not been noticed by your doctor, please inform him or her immediately.
Če menite, da je kateri od opisanih neželenih učinkov hud in ga zdravnik ni opazil, ga nemudoma obvestite.
STORING BEROMUN
SHRANJEVANJE BEROMUNA
BEROMUN should be stored unopened and undissolved in a refrigerator (2°C - 8°C).
BEROMUN je treba shranjevati v zaprti ovojnini in neraztopljenega v hladilniku (2 °C– 8 °C).
Your doctor has been recommended to use BEROMUN as soon as possible after reconstitution in the supplied solution of sodium chloride (saline).
Vaš zdravnik je prejel priporočilo, naj uporabi BEROMUN čimprej po pripravi s priloženo raztopino natrijevega klorida (solne raztopine).
Your doctor will note the expiry date on the pack.
Zdravnik bo upošteval datum izteka roka uporabnosti, ki je naveden na zunanji ovojnini.
BEROMUN will not be used after this date.
BEROMUNA po izteku navedenega roka uporabnosti ne bo uporabil.
BEROMUN is for single use only and any unused solution will be carefully disposed of by your doctor.
Zdravnik bo neporabljeno raztopino pazljivo zavrgel.
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