FrancophonIA/ELRC3.0 huggingface dataset:
English: How does Luminity work?
Slovenian: Kako zdravilo Luminity deluje?
English: 2 carton pack.
Slovenian: Pakiranje z dvema škatlama.
English: Content (concentration)
Slovenian: Pot uporabe Ovojnina Vsebina (koncentraci ja)
English: 40 mg/0.8 ml
Slovenian: Velikost pakiranja mg/0,8 ml raztopina za injiciranje viala (steklo) 0,8 ml (40 mg / 0,8 ml)
English: Route of Administration
Slovenian: Številka EU
English: 2 pre-filled syringes + 2
Slovenian: 2 napolnjeni injekcijski brizgi s ščitnikom za iglo + 2 alkoholna zloženca
English: 1 alcohol pad
Slovenian: 1 viala +
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Slovenian: Jakost Farmacevtska oblika
English: Each carton contains: 1 vial + 1 syringe + 1 needle + 1 sterile adapter + 2 alcohol pads
Slovenian: 6 napolnjenih injekcijskih brizg s ščitnikom za iglo + 6 alkoholnih zložencev
English: Pack size
Slovenian: Izmišljeno ime
English: This summary was last updated in 04-2011.
Slovenian: Povzetek je bil nazadnje posodobljen 04-2011.
English: As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 04 July 2008.
Slovenian: Ker je družba predložila zahtevane dodatne informacije, so „izjemne okoliščine“ prenehale veljati 4. julija 2008.
English: The main measure of effectiveness was the overall response to treatment.
Slovenian: Glavno merilo učinkovitosti je bil splošen odziv na zdravljenje.
English: This is called ‘dose escalation'.
Slovenian: Ta postopek se imenuje „stopnjevanje odmerka“.
English: After this, the recommended dose is 30 mg three times a week (every other day) for a maximum of 12 weeks.
Slovenian: Po tem obdobju je priporočeni odmerek 30 mg trikrat tedensko (vsak drugi dan), ki se jemlje največ 12 tednov.
English: MabCampath was originally authorised under ‘exceptional circumstances', because, for scientific reasons, it had not been possible to obtain complete information on the medicine.
Slovenian: Zdravilo MabCampath je bilo prvotno odobreno „v izjemnih okoliščinah“, saj zaradi znanstvenih razlogov ni bilo mogoče pridobiti vseh informacij o zdravilu.
English: The full EPAR for MabCampath can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo MabCampath je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The marketing authorisation holder is Genzyme Europa BV.
Slovenian: Imetnik dovoljenja za promet je družba Genzyme Europe BV.
English: The European Commission granted a marketing authorisation valid throughout the European Union for MabCampath on 6 July 2001.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom MabCampath, veljavno po vsej Evropski uniji, odobrila dne 6. julija 2001.
English: This is a summary of the European public assessment report (EPAR) for MabCampath.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo MabCampath.
English: • who have an active infection that has spread throughout the body; • with HIV infection;
Slovenian: • bolnikih z aktivno okužbo, ki se je razširila po vsem telesu;
English: MabCampath is given as an infusion lasting about two hours.
Slovenian: Zdravilo MabCampath se daje kot infuzija, ki traja približno 2 uri.
English: The main measure of effectiveness was how long it took until the disease got worse or the patient died.
Slovenian: Glavno merilo učinkovitosti je bil čas, v katerem se je bolniku bolezensko stanje poslabšalo, oziroma čas do smrti bolnika.
English: In the patients receiving MabCampath, it took an average of 14.6 months for the disease to get worse or for the patient to die, compared with 11.7 months in those taking chlorambucil.
Slovenian: Pri bolnikih, ki so prejemali zdravilo MabCampath, je v povprečju trajalo 14,6 meseca, da se je bolezensko stanje poslabšalo ali da je bolnik umrl, pri tistih, ki so jemali klorambucil, pa je to obdobje trajalo 11,7 meseca.
English: During the first week of treatment, MabCampath should be given in increasing doses: 3 mg on day 1, 10 mg on day 2 and 30 mg on day 3, as long as each dose is well tolerated.
Slovenian: Med prvim tednom zdravljenja je treba odmerek zdravila MabCampath povečevati: prvi dan 3 mg, drugi dan 10 mg in tretji dan 30 mg, vse dokler bolnik dani odmerek še dobro prenaša.
English: In the study of patients who had been treated with fludarabine before, 33% responded partially or completely to treatment with MabCampath.
Slovenian: V študiji bolnikov, ki so predhodno že bili zdravljeni s fludarabinom, se je na zdravljenje z zdravilom MabCampath delno ali popolnoma odzvalo 33 % bolnikov.
English: The most frequent serious adverse reactions are low counts of blood cells, infusion reactions, and infections or immunosuppression (reduced activity of the immune system).
Slovenian: Najpogostejše neželene resne reakcije so nizko število krvnih celic, reakcije na infundiranje in okužbe ali imunosupresija (oslabljeno delovanje imunskega sistema).
English: In these studies, MabCampath was not compared with any other treatment.
Slovenian: V teh študijah zdravila MabCampath niso primerjali z nobenim drugim zdravilom.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo MabCampath, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The most frequent side effects with MabCampath are: infusion reactions (fever, chills, low blood pressure, itching, feeling sick, hives, increased heart rate, breathlessness), low counts of blood cells (white blood cells, platelets and red blood cells), infections (signs of cytomegalovirus in the blood, cytomegalovirus infection or other infections), gastrointestinal symptoms (feeling sick, vomiting, abdominal pain) and neurological symptoms (insomnia, anxiety).
Slovenian: Najpogostejši neželeni učinki zdravila MabCampath so: reakcije na infundiranje (povišana telesna temperatura, mrzlica, nizek krvni tlak, srbečica, slabost, srbeči izpuščaji, povišan srčni utrip, oteženo dihanje), nizko število krvnih telesc (belih krvničk, krvnih ploščic in rdečih krvničk), okužbe (znaki prisotnosti citomegalovirusa v krvi, okužbe s citomegalovirusom ali druge okužbe), gastrointestinalni simptomi (slabost, bruhanje, bolečine v trebuhu) in nevrološki simptomi (nespečnost, anksioznost).
English: Patients should be monitored during treatment to see how they respond, but also to check their blood levels of platelets (components that help the blood to clot) and neutrophils (a type of white blood cell that fights infection): if these are too low the treatment should be interrupted or stopped.
Slovenian: Bolnike je treba med zdravljenjem spremljati, da bi videli kako se odzivajo, pa tudi da bi preverili njihove krvne ravni trombocitov (krvnih ploščic, ki pomagajo pri strjevanju krvi) in nevtrofilcev (belih krvnih telesc, ki se borijo proti okužbam): če so te prenizke, je treba zdravljenje začasno ali trajno prekiniti.
English: One study included 297 patients who had not received treatment before.
Slovenian: Ena študija je vključevala 297 bolnikov, ki predhodno še niso bili zdravljeni.
English: The company that makes MabCampath will provide a brochure containing information on the medicine's safety to all doctors in all Member States who prescribe the medicine.
Slovenian: Družba, ki izdeluje zdravilo MabCampath, bo zdravnikom v vseh državah članicah, ki predpisujejo zdravilo, zagotovila brošuro z informacijami o varnosti zdravila.
English: What measures are being taken to ensure the safe use of MabCampath?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila MabCampath?
English: The other three studies looked at a total of 149 patients who had already received other treatments.
Slovenian: Druge tri študije so vključevale skupno 149 bolnikov, ki so že prejeli druge vrste zdravljenja.
English: For more information about treatment with MabCampath, read the package leaflet (also part of the EPAR) or contact your doctor or
Slovenian: Za več informacij o zdravljenju z zdravilom MabCampath preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: MabCampath treatment should be supervised by a doctor experienced in the use of cancer treatments.
Slovenian: Zdravljenje z zdravilom MabCampath mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem raka.
English: In patients who had not received treatment before, MabCampath was more effective than chlorambucil.
Slovenian: Pri bolnikih, ki predhodno še niso bili zdravljeni, je bilo zdravilo MabCampath učinkovitejše od klorambucila.
English: Alemtuzumab has been designed to attach to a glycoprotein (a protein that is coated with sugar molecules) called CD52 that is found on the surface of lymphocytes.
Slovenian: Alemtuzumab je bil zasnovan tako, da se veže na glikoprotein (beljakovino, ki je obdana z molekulami sladkorja), imenovan CD52, ki ga najdemo na površini limfocitov.
English: What benefit has MabCampath shown during the studies?
Slovenian: Kakšne koristi je zdravilo MabCampath izkazalo med študijami?
English: One of these studies included 93 patients in whom previous treatment with fludarabine had stopped working.
Slovenian: Ena od teh študij je vključevala 93 bolnikov, pri katerih predhodno zdravljenje s fludarabinom ni bilo več učinkovito.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in certain cells in the body.
Slovenian: To protitelo (vrsta beljakovine) je zasnovano tako, da prepozna posebno strukturo (imenovano antigen), ki se nahaja v določenih celicah v telesu, in se veže nanjo.
English: MabCampath has been looked at in four main studies involving a total of 446 patients with CLL.
Slovenian: Zdravilo MabCampath je bilo raziskano v štirih glavnih študijah, v katerih je sodelovalo 446 bolnikov s kronično limfocitno levkemijo.
English: It contains the active substance alemtuzumab (10 mg/ml or 30 mg/ml).
Slovenian: Vsebuje 10 mg/ml ali 30 mg/ml zdravilne učinkovine alemtuzumab.
English: MabCampath should not be used in people who may be hypersensitive (allergic) to alemtuzumab, mouse proteins, or any of the other ingredients.
Slovenian: Zdravila MabCampath ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) alemtuzumab, mišje beljakovine ali katerokoli drugo sestavino zdravila.
English: See the summary of product characteristics (also part of the EPAR) for full details.
Slovenian: Za podrobnosti glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
English: MabCampath must not be used in patients:
Slovenian: Zdravilo MabCampath se ne sme uporabljati pri:
English: They should also receive antibiotics and antiviral medicines during and after
Slovenian: Med zdravljenjem in po njem mora bolnik prejemati tudi antibiotike in protivirusna zdravila.
English: MabCampath is used to treat patients with B-cell chronic lymphocytic leukaemia (B-CLL), a cancer of a type of white blood cell called B lymphocytes.
Slovenian: Zdravilo MabCampath se uporablja za zdravljenje bolnikov z B-celično kronično limfocitno levkemijo (B-CLL), vrsto raka belih krvnih telesc, imenovanih B-limfociti.
English: The active substance in MabCampath, alemtuzumab, is a monoclonal antibody.
Slovenian: Zdravilna učinkovina v zdravilu MabCampath, alemtuzumab, je monoklonsko protitelo.
English: The CHMP noted that the effectiveness of MabCampath had been demonstrated, but that there is no information from studies directly comparing MabCampath with treatment combinations including fludarabine, which are widely used to treat patients with CLL.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je ugotovil, da je bila učinkovitost zdravila MabCampath dokazana, vendar pa ni informacij iz študij, v katerih so zdravilo MabCampath neposredno primerjali s kombiniranimi zdravljenji, ki vključujejo fludarabin, ki se pogosto uporabljajo za zdravljenje bolnikov s kronično limfocitno levkemijo.
English: MabCampath is used in patients for whom treatment combinations including fludarabine (another medicine used in leukaemia) are not appropriate.
Slovenian: Zdravilo MabCampath se uporablja pri bolnikih, pri katerih druge vrste zdravljenja, vključno s fludarabinom (drugim zdravilom za zdravljenje levkemije), niso primerna.
English: Patients should be given steroids, an antihistamine and a painkiller before the first dose and before any increase in dose.
Slovenian: Pred prvim odmerkom in pred kakršnim koli povečanjem odmerka je treba bolniku dati steroide, antihistamin in sredstvo proti bolečinam.
English: • who have an active, second cancer; • who are pregnant.
Slovenian: • bolnikih z aktivnim drugim rakavim obolenjem;
English: What is the risk associated with MabCampath?
Slovenian: Kakšna tveganja so povezana z zdravilom MabCampath?
English: The Committee recommended that MabCampath be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo MabCampath odobri dovoljenje za promet.
English: It compared a 12-week course of MabCampath with a year-long course of chlorambucil (another anticancer medicine).
Slovenian: V tej študiji so učinkovitost 12-tedenskega zdravljenja z zdravilom MabCampath primerjali z enoletnim zdravljenjem s klorambucilom (drugo vrsto zdravila proti raku).
English: In CLL, too many lymphocytes are produced.
Slovenian: Pri kronični limfocitni levkemiji nastaja preveliko število limfocitov.
English: Why has MabCampath been approved?
Slovenian: Zakaj je bilo zdravilo MabCampath odobreno?
English: As a result, the lymphocytes die, and this helps to control the CLL.
Slovenian: Posledica te vezave je, da limfociti odmrejo, kar pomaga nadzirati kronično limfocitno levkemijo.
English: MabCampath is a concentrate that is made up into a solution for infusion (drip into a vein).
Slovenian: Zdravilo MabCampath je koncentrat za pripravo raztopine za infundiranje (kapalne infuzije v veno).
English: Therefore, the Committee concluded that MabCampath's benefits are greater than its risks for the treatment of patients with B-CLL for whom fludarabine combination chemotherapy is not appropriate.
Slovenian: Odbor je zaključil, da so koristi zdravila MabCampath pri zdravljenju bolnikov z B-celično kronično limfocitno levkemijo, pri katerih s fludarabinom kombinirana kemoterapija ni bila primerna, večje od z njim povezanih tveganj.
English: How does MabCampath work?
Slovenian: Kako zdravilo MabCampath deluje?
English: For the full list of all side effects reported with MabCampath,
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila MabCampath, glejte navodilo za uporabo.
English: Similar results were seen in the other two studies of
Slovenian: Podobni rezultati so bili doseženi tudi v drugih dveh študijah, v katerih so sodelovali bolniki, ki so se predhodno že zdravili.
English: 90 (3 x 30) capsules
Slovenian: 90 (3 x 30) kapsul
English: Further information on Imfinzi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije o zdravilu Imfinzi so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Treatment should continue for as long as the patient benefits from it or for up to 1 year.
Slovenian: Zdravljenje je treba nadaljevati, dokler je za bolnika koristno, oziroma največ eno leto.
English: What measures are being taken to ensure the safe and effective use of Imfinzi?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Imfinzi?
English: The European Medicines Agency therefore decided that Imfinzi's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Imfinzi večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: The dose is calculated based on the patient's body weight.
Slovenian: Odmerek je odvisen od bolnikove telesne mase.
English: As for all medicines, data on the use of Imfinzi are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Imfinzi stalno spremljajo.
English: What benefits of Imfinzi have been shown in studies?
Slovenian: Kakšne koristi zdravila Imfinzi so se pokazale v študijah?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Imfinzi have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Imfinzi upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Other information about Imfinzi
Slovenian: Druge informacije o zdravilu Imfinzi
English: What is Imfinzi and what is it used for?
Slovenian: Kaj je zdravilo Imfinzi in za kaj se uporablja?
English: The most common serious side effect (which may affect up to 1 in 10 people) is pneumonia (infection of the lungs).
Slovenian: Najpogostejši resen neželeni učinek (ki se lahko pojavi pri več kot 1 bolniku od 10) je pljučnica (okužba pljuč).
English: Side effects with Imfinzi were considered manageable, and its safety profile acceptable and in line with that of similar medicines.
Slovenian: Neželeni učinki zdravila Imfinzi veljajo za obvladljive, varnostni profil pa je sprejemljiv in v skladu s profili podobnih zdravil.
English: The use of Imfinzi is restricted to patients whose tumours produce PD-L1, since a clear benefit was only shown in this group of patients.
Slovenian: Uporaba zdravila Imfinzi je omejena na bolnike s tumorji, ki proizvajajo beljakovino PD-L1, saj se je očitna korist pokazala le pri tej skupini bolnikov.
English: Side effects reported with Imfinzi are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Imfinzi, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: The most common side effects with Imfinzi (which may affect more than 1 in 5 people) are cough, nose and throat infections, and rash.
Slovenian: Najpogostejši neželeni učinki zdravila Imfinzi (ki se lahko pojavijo pri več kot 1 bolniku od 5) so kašelj, okužbe nosu in grla ter izpuščaj.
English: An overview of Imfinzi and why it is authorised in the EU
Slovenian: Pregled zdravila Imfinzi in zakaj je odobreno v EU
English: Why is Imfinzi authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Imfinzi odobreno v EU?
English: For more information about using Imfinzi, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Imfinzi glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Preliminary results also indicated that patients given Imfinzi lived longer overall, compared with patients on placebo, though longer monitoring would be needed to confirm the extent of the benefit.
Slovenian: Iz predhodnih rezultatov je razvidno tudi, da so bolniki, ki so jemali zdravilo Imfinzi, na splošno živeli dlje v primerjavi z bolniki, ki so jemali placebo, čeprav bi za natančnejši obseg teh koristi bilo potrebno daljše opazovanje.
English: In one main study of 713 patients, patients given Imfinzi lived on average for around 17 months without their disease getting worse, compared with 6 months for those given placebo.
Slovenian: V eni glavni študiji, v katero je bilo vključenih 713 bolnikov, so bolniki, ki so jemali zdravilo Imfinzi, brez poslabšanja bolezni povprečno preživeli 17 mesecev, bolniki, ki so jemali placebo, pa le šest mesecev.
English: What are the risks associated with Imfinzi?
Slovenian: Kakšna tveganja so povezana z zdravilom Imfinzi?
English: The active substance in Imfinzi, durvalumab, is a monoclonal antibody, a type of protein designed to recognise and attach to a protein called ‘programmed death-ligand 1' (PD-L1), which is present on the surface of many cancer cells.
Slovenian: Učinkovina v zdravilu Imfinzi, durvalumab, je monoklonsko protitelo, tj. vrsta beljakovine, ki je bila zasnovana tako, da prepozna beljakovino, imenovano ligand za programirano celično smrt 1 (PD-L1), ki je prisotna na površini številnih rakavih celic, in se veže nanjo.
English: Imfinzi can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in treating cancer.
Slovenian: Predpisovanje in izdaja zdravila Imfinzi je le na recept, zdravljenje pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem raka.
English: Imfinzi is used in adult patients with advanced cancer that cannot be removed by surgery but is not getting worse after treatment with radiation and platinum-based chemotherapy (medicines to treat cancer).
Slovenian: Zdravilo Imfinzi se uporablja pri odraslih bolnikih z napredovalim rakom, ki ga ni mogoče odstraniti s kirurškim posegom, a po zdravljenju z obsevanjem in kemoterapijo na osnovi platine (zdravila za zdravljenje raka) ne napreduje.
English: By attaching to PDL1 and blocking its effects, Imfinzi increases the ability of the immune system to attack the cancer cells and thereby slow down the progression of the disease.
Slovenian: Zdravilo Imfinzi z vezavo na beljakovino PD-L1 in zaviranjem njenega učinka poveča zmožnost imunskega sistema, da napade rakave celice in tako upočasni napredovanje bolezni.
English: PD-L1 acts to switch off immune cells that would otherwise attack the cancer cells.
Slovenian: PD-L1 izključi imunske celice, ki bi sicer napadle rakave celice.
English: For the full list of side effects and restrictions of Imfinzi, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Imfinzi glejte navodilo za uporabo.
English: Imfinzi is given as an infusion (drip) into a vein every 2 weeks.
Slovenian: Zdravilo Imfinzi se daje vsaka dva tedna z infundiranjem (kapalno infuzijo) v veno.
English: Imfinzi is a medicine used to treat a type of lung cancer called non-small cell lung cancer (NSCLC).
Slovenian: Zdravilo Imfinzi se uporablja za zdravljenje vrste pljučnega raka, ki se imenuje nedrobnocelični rak pljuč.
English: Imfinzi has been shown to be more effective than placebo (a dummy treatment) at prolonging the time patients with advanced non-small cell lung cancer lived without their disease getting worse.
Slovenian: Dokazano je bilo, da je zdravilo Imfinzi učinkoviteje od placeba (zdravila brez učinkovine) pri podaljševanju časa, ki ga bolniki z napredovalim nedrobnoceličnim rakom preživijo brez poslabšanja bolezni.
English: Imfinzi was shown to improve the length of time patients with advanced NSCLC lived without their disease getting worse, and this was considered important for these patients, who have few treatment options.
Slovenian: Dokazano je bilo, da zdravilo Imfinzi podaljšuje čas, ki ga bolniki z napredovalim nedrobnoceličnim rakom pljuč preživijo, ne da bi se jim bolezen poslabšala, kar se za te bolnike, ki nimajo veliko možnosti za zdravljenje, šteje kot pomembno.
English: Imfinzi is used specifically when the tumour produces a protein known as PD-L1.
Slovenian: Uporablja se takrat, kadar tumor proizvaja beljakovino PD-L1.
English: How does Imfinzi work?
Slovenian: Kako zdravilo Imfinzi deluje?
English: Imfinzi contains the active substance durvalumab.
Slovenian: Zdravilo Imfinzi vsebuje učinkovino durvalumab.
English: How is Imfinzi used?
Slovenian: Kako se zdravilo Imfinzi uporablja?