natgillin/translations-raw huggingface dataset:
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.
The MAH shall draw up global corrective and preventive actions (CAPA) and use them to prevent endotoxin contamination at other sites producing dialysis solutions.
Imetnik dovoljenja za promet z zdravilom pripravi celovite korektivne in preventivne ukrepe ter jih izvaja za preprečevanje kontaminacije z endotoksini tudi v drugih proizvodnih obratih, kjer proizvaja dializne raztopine.
This RMP shall follow the EU RMP template (as referenced in Volume 9a of The Rules Governing Medicinal Products in the European Union) and shall include the measures to assess the effectiveness of the risk minimisation in the agreed consolidated RMP.
Ta načrt za obvladovanje tveganja bo oblikovan v skladu s predlogo načrta EU za obvladovanje tveganja (kot navaja zvezek 9a Pravil, ki urejajo zdravila v Evropski uniji) in bo vključeval ukrepe za ocenjevanje učinkovitosti zmanjševanja tveganja v dogovorjenem celovitem načrtu za obvladovanje tveganja.
During inspections of the local sites located under their territories, member states shall ensure that the MAH has appropriately transposed the experience acquired in Castlebar, in accordance with the global CAPA.
Države članice zagotovijo, da je med inšpekcijskimi pregledi obratov na njihovem ozemlju imetnik dovoljenja za promet z zdravilom ustrezno prenesel izkušnje, pridobljene v Castlebaru, v skladu s celovitimi in korektivnimi ukrepi.
The MAH shall perform a 12 month monitoring after site qualification by the supervisory authority (IMB) in Castlebar.
Imetnik dovoljenja za promet z zdravilom po kvalifikaciji obrata s strani nadzornega organa (IMB) v Castlebaru izvede 12-mesečno spremljanje.
The MAH shall perform epidemiological studies consisting of a clinical audit that will collect data on the number of peritonitis events in the EU in 2010 and 2011 and an observational study to assess the nature of peritonitis and non-peritonitis cases (including fatal outcomes) and their outcome, in accordance with the milestones for evaluation and reporting described in the consolidated RMP.
Imetnik dovoljenja za promet z zdravilom izvede v skladu z mejniki za ocenjevanje in poročanje, opisanimi v celovitem načrtu za obvladovanje tveganja, epidemiološke študije, sestavljene iz klinične presoje, v kateri bodo zbrani podatki o številu dogodkov peritonitisa v EU v letih 2010 in 2011, ter opazovalne študije, v kateri se bo ocenila oblika peritonitisa in primerov brez peritonitisa (vključno s primeri s smrtnim izidom).
Conditions to be fulfilled by the MAH:
Imetnik dovoljenja za promet z zdravilom mora izpolniti naslednje pogoje:
Further information on Ubac can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Nadaljnje informacije o zdravilu UBAC so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
If pain persists for more than 12 hours after medical examination, the doctor should be contacted again.
Če bolečina ne izgine po več kot 12 urah po zdravniškem pregledu, se je treba znova posvetovati z zdravnikom.
The European Medicines Agency decided that Ubac's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je odločila, da so koristi zdravila UBAC večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
This will help protect the cattle against the infection and reduce the risk of mastitis.
S tem govedo zaščitimo pred okužbo in zmanjšamo tveganje za mastitis.
The full course should be repeated with each pregnancy.
Celoten postopek je treba ponoviti ob vsaki brejosti.
The vaccine also contains ‘adjuvants' (Montanide ISA and MPLA) to stimulate a better reaction by the immune system.
Cepivo vsebuje tudi „adjuvansa“ (montanid ISA in MPLA), ki spodbudita boljši odziv imunskega sistema.
Protection starts about 36 days after the second injection and lasts for the first 5 months of lactation (milk production).
Zaščita začne učinkovati približno 36 dni po drugi injekciji in traja prvih pet mesecev laktacije (proizvodnje mleka).
Ubac (Streptococcus uberis vaccine, inactivated) EMA/296128/2018
UBAC (cepivo proti Streptococcus uberis, inaktivirano) EMA/296128/2018
What benefits of Ubac have been shown in studies?
Kakšne koristi zdravila UBAC so se pokazale v študijah?
During a 21 week observation period the incidence of new cases of S. uberis clinical mastitis was 50% lower in the group of 277 cattle vaccinated with Ubac compared to the group of 303 cattle given placebo (dummy treatment) (6.1% versus 12.2%).
Med 21-tedenskim opazovalnim obdobjem je bila pojavnost novih primerov kliničnega mastitisa zaradi bakterije S. uberis za 50 % manjša v skupini 277 goved, cepljenih z zdravilom UBAC, v primerjavi s skupino 303 goved, ki so prejela placebo (zdravilo brez učinkovine) (6,1 % v primerjavi z 12,2 %).
Why is Ubac authorised in the EU?
Zakaj je bilo zdravilo UBAC odobreno v EU?
Ubac (Streptococcus uberis vaccine, inactivated)
UBAC (cepivo proti Streptococcus uberis, inaktivirano)
What is Ubac and what is it used for?
Kaj je zdravilo UBAC in za kaj se uporablja?
An overview of Ubac and why it is authorised in the EU
Pregled zdravila UBAC in zakaj je odobreno v EU
Accidental injection may cause severe pain and swelling, particularly if injected into a joint or fingerthis could result in the loss of the finger if prompt medical attention is not given.
Nenamerno injiciranje lahko povzroči hude bolečine in otekline, zlasti ob injiciranju v sklep ali prst na roki - brez takojšnje zdravniške oskrbe lahko pride do izgube prsta.
Other information about Ubac
Druge informacije o zdravilu UBAC
The third injection is given about 15 days after calving.
Tretja injekcija se da približno 15 dni po telitvi.
The whole herd should be vaccinated.
Treba je cepiti celotno čredo.
What are the risks associated with Ubac?
Kakšna tveganja so povezana z zdravilom UBAC?
Ubac received a marketing authorisation valid throughout the EU on 26 July 2018.
Zdravilo UBAC je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 26/07/2018.
The withdrawal period for meat and milk from cattle treated with Ubac is ‘zero' days, which means that there is no mandatory waiting time.
Karenca za meso in mleko goveda, zdravljenega z zdravilom UBAC, je „nič“ dni, kar pomeni, da ni obvezne čakalne dobe.
The first injection is given at about 60 days before the expected calving date followed by a second injection given at least 3 weeks before the expected calving date.
Prva injekcija se da približno 60 dni pred predvidenim datumom telitve, druga injekcija pa najmanj tri tedne pred pričakovanim datumom telitve.
The package leaflet should be shown to the doctor.
Zdravniku je treba pokazati navodilo za uporabo.
For more information about using Ubac, see the package leaflet or contact your veterinarian or pharmacist.
Za več informacij glede uporabe zdravila UBAC glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
In the future, if the animals are exposed to disease-causing S. uberis bacteria, the immune system will be able to respond more quickly.
Če so živali pozneje izpostavljene bakterijam S. uberis, ki povzročajo bolezen, se lahko imunski sistem nanje hitreje odzove.
Ubac is a vaccine used in cows and heifers (female cattle that have not yet calved) to reduce clinical mastitis (udder infections with visible signs in milk or the udder) caused by bacteria called Streptococcus uberis, which can reduce milk production.
Zdravilo UBAC je cepivo, ki se uporablja pri kravah in telicah (govedu ženskega spola, ki še ni telilo), da se zmanjša klinični mastitis (vnetja vimena z vidnimi znaki v mleku ali vimenu), ki ga povzroča bakterija Streptococcus uberis in ki lahko zmanjša proizvodnjo mleka.
Ubac is given as a course of 3 injections into the neck muscles, alternating sides of the neck.
Zdravilo se daje v sklopu treh injiciranj v vratno mišičevje, izmenoma na obeh straneh vratu.
The active substance in Ubac is obtained from the sticky substances that the S. uberis bacteria produce to protect themselves and attach to surfaces (known as biofilm adhesion components).
Učinkovina v zdravilu UBAC je pridobljena iz lepljivih snovi, ki jih proizvaja bakterija S. uberis, da se zaščiti in se z njimi pritrdi na površine (poznanih kot komponente lepljivega biofilma).