natgillin/translations-raw huggingface dataset:
- Wash your hands with soap and water immediately after applying the gel, and also in between administrations if prescribed two different strengths for two different areas. 
- Po nanosu gela in med lokalnimi nanosi, če je treba na dveh različnih mestih uporabiti različne jakosti gela, si nemudoma umijte roke z milom in vodo.
If more than half of the treatment area is located in the upper part of the neck: - Use Picato 150 mcg/g gel (face and scalp) If more than half of the treatment area is located in the lower part of the neck: - Use Picato 500 mcg/g gel (trunk and extremities) 
Če je več kot polovica zdravljenega mesta na spodnjem delu vratu, je treba uporabiti gel Picato 500 μg/g v odmerku za trup in okončine.
Actinic keratosis on the trunk and extremities in adults One tube of Picato 500 mcg/g gel (containing 235 mcg ingenol mebutate) should be applied once daily to the affected area for 2 consecutive days. 
Eno tubo zdravila Picato 500 µg/g gel (ki vsebuje 235 µg ingenolmebutata) je treba enkrat dnevno nanesti na prizadeti predel in postopek ponavljati 2 zaporedna dneva.
No systemic absorption was detected at or above the lower limit of detection (0.1 ng/mL) when Picato 500 mcg/g from 4 tubes was applied to an area of 100 cm2 on the dorsal forearm in actinic keratosis patients once daily for 2 consecutive days. 
100 cm2 na hrbtni strani podlahti pri bolnikih z aktinično keratozo niso opazili sistemske absorpcije na meji zaznavnosti ali nad njo (0,1 ng/ml).
OTHER 
Zaužitje
Each gram of gel contains 150 mcg of ingenol mebutate. 
En gram gela vsebuje 150 µg ingenolmebutata (ingenoli mebutas).
Chest 
Lasišče
OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 
POGOJEV DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
Application site infection 
Ponovitev na zdravljenem predelud
29 August 2014 
29. avgusta 2014
Within 3 months after EC decision 
V roku 3 mesecev po odločbi ES
Outline of the education materials within 3 months after EC decision 
Povzetek izobraževalnega gradiva v roku 3 mesecev od odločbe ES
Conditions to the marketing authorisations 
Pogoji dovoljenj za promet z zdravili
National competent authorities of Member State(s) or reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s): 
Pristojne nacionalne agencije ene ali več držav članic ali referenčnih držav članic bodo zagotovile, kjer je to ustrezno, da imetnik(i) dovoljenja za promet z zdravilom izpolnjuje(jo) naslednje pogoje:
This will be included in the risk management plan, highlighting the risks and warnings of thromboembolism (by e.g. a checklist, to be implemented at national level). 
Gradivo bo vključeno v načrt za obvladovanje tveganja in bo opozarjalo na tveganja in simptome, povezane s trombembolijo (npr. kontrolni seznam, ki se bo uporabljal na nacionalni ravni).
The MAH(s) should provide within the risk management plan submission, a protocol for the drug utilisation study to characterise prescribing practices for the medicinal products during typical clinical use in representative groups of prescribers and to assess main reasons for prescription. 
Imetnik(i) dovoljenja za promet mora(jo) v okviru RMP predložiti protokol za študijo uporabe zdravila, namenjeno razjasnitvi prakse pri predpisovanju zdravil med običajno klinično uporabo pri reprezentativni skupini zdravstvenih delavcev, ki predpisujejo zdravila, in opredelitvi glavnih razlogov za predpisovanje.
The MAH(s) should submit the next PSUR by: 
Imetnik(i) dovoljenja za promet mora(jo) naslednji PSUR predložiti do:
The MAH(s) should submit the core elements (including outline of DUS, PASS and educational materials) of a risk management plan in EU format. 
Imetnik(i) dovoljenja za promet mora(jo) predložiti ključne dele (vključno s študijo uporabe zdravila, študijo PASS in izobraževalnim gradivom) načrta za obvladovanje tveganja v formatu EU.
The MAH(s) should provide a protocol of a PASS within the risk management plan submission, to evaluate the effectiveness of the risk minimisation activities. 
Imetnik(i) dovoljenja za promet mora(jo) v okviru načrta za obvladovanje tveganja predložiti protokol študije PASS, namenjene oceni učinkovitosti dejavnosti za zmanjšanje tveganja.
The MAH(s) should provide within the risk management plan Educational material for prescribers and patients. 
Imetnik(i) dovoljenja za promet mora(jo) v okviru načrta za obvladovanje tveganja predložiti izobraževalno gradivo za zdravstvene delavce, ki bodo predpisovali zdravilo, in bolnice.
This summary was last updated on 12-2017. 
Povzetek je bil nazadnje posodobljen 12-2017.
In addition, the company will report on the 5-year survival rates of patients who took part in studies. 
Poleg tega bo poročala o petletnih stopnjah preživetja bolnikov, ki so bili udeleženi v študijah.
However, more data are needed to fully understand the medicine's effectiveness. 
Vendar je za celovitejše razumevanje učinkovitosti zdravila potrebnih več podatkov.
Each course of treatment with the medicine is given for 5 or 10 days every 35 days. 
Vsak cikel zdravljenja z zdravilom poteka od 5 do 10 dni in se ponovi vsakih 35 dni.
It must be given in hospital by a doctor or nurse who can manage severe allergic reactions and who has full resuscitation services immediately available if needed. 
Dajati ga je treba v bolnišnici, in sicer ga mora dajati zdravnik ali medicinska sestra, ki lahko obvlada hude alergijske reakcije in ima po potrebi takoj na voljo opremo za oživljanje.
The company will also perform tests to obtain more information on how the medicine is processed by the body and how the immune system responds to the medicine. 
Prav tako bo izvajala preiskave, s katerimi bo pridobila več informacij o tem, kako se zdravilo presnavlja v telesu in kako se imunski sistem odziva nanj.
Treatment must be supervised by a doctor experienced in the treatment of cancer. 
Zdravljenje z zdravilom Qarziba mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem raka.
It is used in 2 groups of patients who have high-risk neuroblastoma (which has a high chance of coming back): 
Uporablja se pri dveh skupinah bolnikov, ki imajo nevroblastom z visokim tveganjem (z veliko verjetnostjo za ponovitev):
Every year, the European Medicines Agency will review any new information that becomes available and this summary will be updated as necessary. 
Evropska agencija za zdravila bo vsako leto ponovno pregledala vse nove podatke, ki bodo na voljo, in posodobila povzetek glavnih značilnosti zdravila, če bo potrebno.
At the start of treatment some of these patients had no sign of neuroblastoma and some still had some sign of the disease. 
Na začetku zdravljenja nekateri od teh bolnikov niso imeli znakov nevroblastoma, drugi pa so še vedno imeli znake bolezni.
Qarziba has been authorised under ‘exceptional circumstances'. 
Zdravilo Qarziba je pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
• patients who have had some improvement with previous treatments, which included blood stem cell transplantation (a transplant of blood-producing cells); 
• pri bolnikih, pri katerih je s predhodnimi načini zdravljenja, vključno s presaditvijo krvnih matičnih celic (presaditvijo krvotvornih celic), prišlo do delnega izboljšanja;
The Agency's Committee for Medicinal Products for Human Use (CHMP) noted the lack of treatment options to prevent high-risk neuroblastoma from coming back. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je ugotovil, da obstaja pomanjkanje možnosti zdravljenja za preprečevanje ponovitve nevroblastoma z visokim tveganjem.
The summary of the opinion of the Committee for Orphan Medicinal Products for Qarziba can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation. 
Povzetek mnenja Odbora za zdravila sirote o zdravilu Qarziba je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The doctor may need to reduce or delay doses if certain side effects occur, or stop treatment altogether if side effects are severe. 
Zdravnik bo morda moral odmerek zmanjšati ali počakati z naslednjimi odmerki, če se pojavijo nekateri neželeni učinki, ali popolnoma prekiniti zdravljenje, če so neželeni učinki hudi.
This is a summary of the European public assessment report (EPAR) for Qarziba. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Qarziba.
Qarziba must not be used in patients with severe or widespread graft-versus-host disease (when transplanted cells attack the body). 
Zdravilo Qarziba se ne sme uporabljati pri bolnikih s hudo ali razširjeno boleznijo presadka proti gostitelju (stanjem, pri katerem presajene celice napadejo telo).
This is because it has not been possible to obtain complete information about Qarziba for ethical reasons. 
Do tega je prišlo zato, ker iz etičnih razlogov ni bilo mogoče pridobiti vseh informacij o njem.
Therefore the CHMP decided that Qarziba's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Odbor je zato zaključil, da so koristi zdravila Dinutuksimab beta EUSA večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
As dinutuximab is a recommended treatment for high-risk neuroblastoma, it would not be ethical to carry out a trial in which some patients were given placebo (a dummy treatment). 
Ker je dinutuksimab priporočeno zdravilo za nevroblastom z visokim tveganjem, ne bi bilo etično izvesti preskušanja, pri katerem bi nekateri bolniki prejemali le placebo (zdravilo brez zdravilne učinkovine).
Other information about Qarziba 
Druge informacije o zdravilu Qarziba
Although treatment with Qarziba can cause serious side effects, the safety of the medicine is considered acceptable. 
Čeprav zdravljenje z zdravilom Qarziba lahko povzroči resne neželene učinke, varnost zdravila velja za sprejemljivo.
What is Qarziba and what is it used for? 
Kaj je zdravilo Qarziba in za kaj se uporablja?
The European Commission granted a marketing authorisation valid throughout the European Union for Dinutuximab beta Apeiron on 8 May 2017. 
Evropska komisija je dovoljenje za promet z zdravilom Dinutuksimab beta Apeiron, veljavno po vsej Evropski uniji, izdala 8. maja 2017.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Qarziba have been included in the summary of product characteristics and the package leaflet. 
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Qarziba upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
The name of the product was changed to Dinutuximab beta EUSA on 4 August 2017 and to Qarziba on 27 November 2017. 
Ime zdravila je bilo 4. avgusta 2017 spremenjeno v Dinutuksimab beta EUSA in 27. novembra 2017 v Qarziba.
If the neuroblastoma has come back after previous treatment, it should be stabilised (stopped from getting worse) before treatment with Qarziba is started. 
Če se je nevroblastom po predhodnem zdravljenju ponovil, ga je treba pred začetkom zdravljenja z zdravilom Qarziba stabilizirati (zaustaviti slabšanje stanja).
Previously known as Dinutuximab beta Apeiron and Dinutuximab beta EUSA. 
Prej znano kot Dinutuksimab beta Apeiron in Dinutuksimab beta EUSA.
Qarziba is a cancer medicine used to treat neuroblastoma, a cancer of nerve cells, in patients over 1 year of age. 
Zdravilo Qarziba je zdravilo proti raku, ki se uporablja za zdravljenje nevroblastoma, tj. raka živčnih celic, pri bolnikih, starejših od enega leta.
The full EPAR for Qarziba can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Qarziba je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Because the number of patients with neuroblastoma is low, the disease is considered ‘rare', and Qarziba was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 November 2012. 
Ker je bolnikov z nevroblastomom malo, velja ta bolezen za redko, zato je bilo zdravilo Qarziba 8. novembra 2012 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
Studies have shown that Qarziba is effective at increasing survival in patients with neuroblastoma. 
Študije so pokazale, da je zdravilo Qarziba učinkovito pri podaljševanju preživetja bolnikov z nevroblastomom.
Qarziba is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a structure called GD2 that is present in high amounts on the surface of neuroblastoma cells, but not normal cells. 
Zdravilo Qarziba je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da prepozna strukturo, imenovano GD2, ki je v večjih količinah prisotna na površini nevroblastomskih celic, in se veže nanjo.
Why is Qarziba approved? 
Zakaj je bilo zdravilo Qarziba odobreno?
When Qarziba attaches to the neuroblastoma cells, it makes them a target for the body's immune system (the body's natural defences), which then kills the cancer cells. 
Ko se zdravilo Qarziba pritrdi na nevroblastomske celice, te postanejo tarča za telesni imunski sistem (naravni obrambni mehanizem telesa), ki nato uniči rakave celice.
Treatment with Qarziba should not be started unless the patient has satisfactory results in certain blood tests of liver, lung, kidney and bone marrow function. 
Zdravljenje z zdravilom Qarziba se sme uvesti samo, če ima bolnik zadovoljive rezultate določenih krvnih preiskav delovanja jeter, pljuč, ledvic in kostnega mozga.
The most common side effects with Qarziba (which may affect more than 7 in 10 people) are pyrexia (fever) and pain. 
Najpogostejša neželena učinka zdravila Qarziba (ki se lahko pojavita pri več kot 7 bolnikih od 10) sta pireksija (povišana telesna temperatura) in bolečina.
Since Qarziba has been approved under exceptional circumstances, the company that markets Qarziba will monitor the safety of the medicine using a patient registry and provide yearly updates. 
Ker je zdravilo Qarziba pridobilo dovoljenje za promet v izjemnih okoliščinah, bo družba, ki ga trži, s pomočjo registra bolnikov spremljala njegovo varnost ter vsakoletno posodobila podatke.
It is not intended to provide practical advice on how to use Qarziba. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Taken together, data on outcomes with Qarziba show that the medicine is effective. 
Skupni podatki o izidih zdravljenja z zdravilom Qarziba kažejo, da je zdravilo učinkovito.
What information is still awaited for Qarziba? 
Katere informacije o zdravilu Qarziba še pričakujemo?
For more information about treatment with Qarziba, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Qarziba preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
In these studies, 70% and 78% of the patients whose neuroblastoma had not improved with other treatments were still alive 2 years after treatment. 
V teh študijah je bilo 70 % oziroma 78 % bolnikov, pri katerih se nevroblastom z drugimi načini zdravljenja ni izboljšal, dve leti po zdravljenju še živih.
Two studies analysed data from 88 children and adults with neuroblastoma that had not improved with other cancer treatments or had come back. 
V dveh študijah so analizirali podatke 88 otrok in odraslih z nevroblastomom, ki se po zdravljenju z drugimi zdravili proti raku ni izboljšal ali se je ponovil.
• patients whose neuroblastoma has not improved with other cancer treatments or has come back. 
• pri bolnikih, pri katerih se nevroblastom po zdravljenju z drugimi načini zdravljenja raka ni izboljšal ali se je ponovil.
For practical information about using Qarziba, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Qarziba naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
(allergy), vomiting, diarrhoea, capillary leak syndrome (leakage of fluid from blood vessels that can cause swelling and a drop in blood pressure) and hypotension (low blood pressure). 
Drugi neželeni učinki (ki se lahko pojavijo pri več kot 3 bolnikih od 10) so preobčutljivost (alergija), bruhanje, driska, sindrom kapilarne prepustnosti (uhajanje tekočine iz žil, ki lahko povzroči otekanje in padec krvnega tlaka) in hipotenzija (nizek krvni tlak).
What measures are being taken to ensure the safe and effective use of Qarziba? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila
In a third study, 370 children with high-risk neuroblastoma that had improved after other treatments were given Qarziba and isotretinoin with or without interleukin-2. 
V tretji študiji je 370 otrok z nevroblastomom z visokim tveganjem, ki se je z drugimi načini zdravljenja izboljšal, prejemalo zdravilo Qarziba in izotretinoin v kombinaciji z interlevkinom-2 ali brez njega.
Patients were treated with Qarziba plus interleukin-2 and another medicine called isotretinoin. 
Bolnike so zdravili z zdravilom Qarziba in interlevkinom-2 ter drugim zdravilom, imenovanim izotretinoin.
Of the patients who had no sign of neuroblastoma, 71% were still alive 3 years after treatment and the results were similar whether the treatment included interleukin-2 or not. 
Med bolniki, ki niso imeli znakov nevroblastoma, jih je bilo 71 % tri leta po zdravljenju še živih, rezultati pa so bili podobni ne glede na to, ali je bil interlevkin-2 vključen v zdravljenje ali ne.
Results of a study looking at the effect of giving Qarziba together with interleukin-2 will be provided by the company. 
Predložila bo rezultate študije, s katero bodo proučili učinek dajanja zdravila Qarziba skupaj z interlevkinom-2.
Of the patients who had some sign of neuroblastoma, 63% of those given interleukin-2 were still alive 3 years after treatment compared with 54% of patients who did not receive interleukin-2. 
Med bolniki, ki so še imeli določene znake nevroblastoma, je bilo tri leta po zdravljenju živih še 63 % bolnikov, ki so prejemali interlevkin-2, v primerjavi s 54 % bolnikov, ki interlevkina-2 niso prejemali.
What are the risks associated with Qarziba? 
Kakšna tveganja so povezana z zdravilom Qarziba?
For the full list of all side effects and restrictions with Qarziba, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Qarziba glejte navodilo za uporabo.
The recommended dose depends on the patient's weight and height. 
Skupno število ciklov je pet. Priporočeni odmerek je odvisen od bolnikove telesne mase in višine.
The medicine contains the active substance dinutuximab beta. 
Zdravilo vsebuje zdravilno učinkovino dinutuksimab beta.
How is Qarziba used? 
Kako se zdravilo Qarziba uporablja?
Qarziba is given as an infusion (drip) into a vein. 
Zdravilo Qarziba se daje z infundiranjem (kapalno infuzijo) v veno.
Of the patients with neuroblastoma that had come back, 42% and 69% were still alive 2 years after treatment. 
Med bolniki, pri katerih se je nevroblastom ponovil, jih je bilo dve leti po zdravljenju živih še 42 % oziroma 69 %.
In these studies, outcomes with Qarziba compared favourably with those previously seen in patients treated for neuroblastoma without Qarziba. 
V teh študijah so bili izidi zdravljenja z zdravilom Qarziba boljši od prej opaženih izidov zdravljenja pri bolnikih, pri katerih nevroblastoma niso zdravili s tem zdravilom.
What benefits of Qarziba have been shown in studies? 
Kakšne koristi je zdravilo Dinutuksimab beta EUSA izkazalo v študijah?
How does Qarziba work? 
Kako zdravilo Qarziba deluje?
EPAR summary for the public 
Povzetek EPAR za javnost dinutuksimab beta
Qarziba is used together with another medicine called interleukin-2 (aldesleukin) in some cases where previous treatments have not worked well enough. 
V nekaterih primerih, in sicer kadar predhodni načini zdravljenja niso bili dovolj učinkoviti, se zdravilo uporablja skupaj z drugim zdravilom, imenovanim interlevkin-2 (aldeslevkin).
Conditions to be implemented by the Member States: 
Pogoji, ki jih morajo izpolniti države članice:
Annex III Conditions of the marketing authorisations 
Priloga III Pogoji dovoljenj za promet z zdravilom
The plan shall detail all changes to processes, frequencies or limits resulting from the monitoring. 
Načrt navaja vse spremembe postopkov, pogostnosti ali omejitev, ki so posledica spremljanja.
A pharmacovigilance inspection shall be carried out by the competent authority by end of September 2012. 
Do konca septembra 2012 pristojni organ izvede farmakovigilančni pregled.
Within 90 days of the finalisation of said monitoring period, a change management plan shall be submitted to the national competent authorities. 
V 90 dneh po zaključku navedenega obdobja spremljanja je treba nacionalnim pristojnim organom predložiti načrt upravljanja sprememb.
Care should be taken to ensure consistency with the inspections of the Castlebar site. 
Posebno pozornost je treba nameniti zagotavljanju doslednosti z inšpekcijskimi pregledi obrata v Castlebaru.
The outcome of the global CAPA shall be provided to the national competent authorities and any changes considered necessary shall be addressed through the appropriate change management protocols and regulatory procedures at a national level, as applicable. 
Izid globalnih korektivnih in preventivnih ukrepov predloži pristojnim nacionalnim organom, morebitne potrebne spremembe pa ustrezno uveljavi z ustreznimi protokoli za upravljanje sprememb in regulativnimi postopki na nacionalni ravni.
The MAH shall update the marketing authorisations of the affected dialysis solutions with the improved microbiological analytical methodologies and inclusion of new sites for increasing the diversity of supply in accordance with the change management plan and its timelines. 
Imetnik dovoljenja za promet z zdravilom posodobi dovoljenja za promet z zadevnimi dializnimi raztopinami z izboljšanimi mikrobiološkimi analitičnimi metodologijami in z vključitvijo novih obratov za povečanje raznovrstnosti oskrbe v skladu z načrtom upravljanja sprememb in njegovim časovnim okvirom.
The outcome of the inspection shall be provided to national competent authorities. 
Rezultat inšpekcijskega pregleda se predloži pristojnim nacionalnim organom.
The inspection of the Castlebar site by the supervisory authority (IMB) shall be performed by end of December 2011 before the solutions can be re-launched. 
Nadzorni organ (IMB) do konca decembra 2011 izvede inšpekcijski pregled obrata v Castlebaru, šele nato se lahko raztopine ponovno sprostitvijo.
Variations should be submitted for assessment by the national competent authorities. 
Različice je treba predložiti v oceno nacionalnim pristojnim organom.
The MAH shall submit to the national competent authorities, at the time of the next Periodic Safety Update Report (PSUR), a risk management plan (RMP) for all affected products using the agreed consolidated RMP, version 2.0 of 21 September 2011, which describes the products' safety concerns (cloudy effluent/aseptic peritonitis with peritoneal dialysis solutions and endotoxin induced systemic inflammatory response with haemodialysis solutions) and their risk minimisation which includes a direct healthcare professional communication and quality activities. 
Imetnik dovoljenja za promet z zdravilom predloži pristojnim nacionalnim organom skupaj s predložitvijo naslednjega z zadnjimi podatki dopolnjenega rednega poročila o varnosti zdravila (PSUR) tudi načrt za obvladovanje tveganja za vsa oporečna zdravila v skladu z dogovorjenim celovitim načrtom za obvladovanje tveganja, različica 2.0 z dne 21. septembra 2011, v katerem so opisani zadržki glede varnosti (moten iztok/aseptični peritonitis pri raztopinah za peritonealno dializo in sistemski vnetni odziv na raztopine za hemodializo zaradi endotoksina) in ukrepi za zmanjševanje tveganja, ki vključujejo neposredna obvestila zdravstvenim delavcem in ukrepe na področju kakovosti.