FrancophonIA/ELRC3.0 huggingface dataset:
English: Premixes containing tiamulin are marketed across the European Union under a variety of invented names and the authorised premix formulations are based on tiamulin hydrogen fumarate in a variety of concentrations: 0.8%, 2%, 10% and 80%.
Slovenian: Predmešanice s tiamulinom se po vsej Evropski uniji tržijo pod različnimi izmišljenimi imeni, odobrene formulacije predmešanice pa temeljijo na tiamulinijevem hidrogenfumaratu v različnih koncentracijah: 0,8 %, 2 %, 10 % in 80 %.
English: Due to differences among the nationally authorised summaries of product characteristics for Tiamutin premix and associated names across the European Union, especially as regards indications for use, amount to be administered and administration route and withdrawal periods, on 18 September 2008 Ireland and Belgium referred the matter to the European Medicines Agency under Article 34 of Directive 2001/82/EC.
Slovenian: Zaradi razlik med nacionalno odobrenimi glavnimi povzetki značilnosti za zdravilo Tiamutin premix in z njim povezana imena v Evropski uniji, še zlasti glede navodila za uporabo, odmerjene količine in poti uporabe ter karence, sta Irska in Belgija dne 18. septembra 2008 v skladu s členom 34 Direktive 2001/82/ES zadevo napotila na Evropsko agencijo za zdravila.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended summary of product characteristics and labelling in Annex III.
Slovenian: Seznam zadevnih imen zdravil je naveden v Dodatku I. Znanstveni zaključki so podani v Dodatku II, skupaj s spremenjenim povzetkom glavnih značilnosti zdravila in označevanjem v Dodatku III.
English: Tiamulin is used for the treatment and prevention of gastrointestinal and respiratory infections caused by different bacterial pathogens in pigs, poultry and rabbits.
Slovenian: Uporablja se za zdravljenje in preprečevanje gastrointestinalnih okužb in okužb dihal, ki jih pri prašičih, perutnini in zajcih povzročajo različni bakterijski povzročitelji.
English: Based on the rapporteurs' assessment of the currently available data, the CVMP adopted, on 10 March 2010, an opinion recommending the amendment of the marketing authorisations in terms of the summary of the product characteristics and labelling in order to harmonise the indications for use, amount to be administered and administration route and withdrawal periods.
Slovenian: Na podlagi poročevalčeve ocene trenutno razpoložljivih podatkov je CVMP dne 10. marca 2010 sprejel mnenje, v katerem priporoča spremembo dovoljenj za promet z zdravilom glede povzetka glavnih značilnost zdravila in označevanja, da bi se uskladili indikacije za uporabo, odmerjene količine, pot uporabe in karence.
English: This overview was last updated in 12-2018.
Slovenian: Pregled je bil nazadnje posodobljen 12-2018.
English: Further information on Yervoy can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Yervoy.
Slovenian: Nadaljnje informacije za zdravilo Yervoy so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Yervoy.
English: What measures are being taken to ensure the safe and effective use of Yervoy?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Yervoy?
English: The effects of Yervoy in adolescents are expected to be similar to those in adults.
Slovenian: Pričakovati je, da bodo učinki zdravila Yervoy pri mladostnikih podobni kot pri odraslih.
English: Patients will also receive from their doctor an alert card summarising key safety information on the medicine.
Slovenian: Bolniki bodo od zdravnika prejeli tudi opozorilno kartico, na kateri so povzete ključne varnostne informacije o zdravilu.
English: Yervoy received a marketing authorisation valid throughout the EU on 13 July 2011.
Slovenian: Za zdravilo Yervoy je bilo 13. julija 2011 izdano dovoljenje za promet, veljavno po vsej EU.
English: The Agency decided that Yervoy's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Agencija je zaključila, da so koristi zdravila Yervoy večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Advanced melanoma
Slovenian: Napredovali melanom
English: What benefits of Yervoy have been shown in studies?
Slovenian: Kakšne koristi zdravila Yervoy so se pokazale v študijah?
English: Other information about Yervoy
Slovenian: Druge informacije o zdravilu Yervoy
English: Why is Yervoy authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Yervoy odobreno v EU?
English: Therefore, all adolescents treated with Yervoy will be monitored closely.
Slovenian: Zato bodo vsi mladostniki, zdravljeni z zdravilom Yervoy, skrbno nadzorovani.
English: An overview of Yervoy and why it is authorised in the EU
Slovenian: Pregled zdravila Yervoy in zakaj je odobreno v EU
English: As for all medicines, data on the use of Yervoy are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Yervoy stalno spremljajo.
English: What are the risks associated with Yervoy?
Slovenian: Kakšna tveganja so povezana z zdravilom Yervoy?
English: Advanced renal cell carcinoma
Slovenian: Napredovali karcinom ledvičnih celic
English: In addition, 41.6% of patients (177 out of 423) responded to the treatment with the combination compared with 26.5% (112 out of 416) of those receiving sunitinib.
Slovenian: Poleg tega se je na zdravljenje s kombinacijo omenjenih zdravil odzvalo 41,6 % (177 od 423) bolnikov v primerjavi s 26,5 % (112 od 416) bolnikov, ki so prejemali sunitinib.
English: What is Yervoy and what is it used for?
Slovenian: Kaj je zdravilo Yervoy in za kaj se uporablja?
English: Several studies have shown that Yervoy is effective in prolonging the lives of patients with advanced melanoma.
Slovenian: Več študij je pokazalo, da je zdravilo Yervoy učinkovito pri podaljševanju življenja bolnikov z napredovalim melanomom.
English: Side effects reported with Yervoy are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Yervoy, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: For more information about using Yervoy, see the package leaflet or contact a doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Yervoy glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: As it is not clear how much Yervoy contributes to the benefits when given in combination with nivolumab in patients with advanced renal cell carcinoma, the company must conduct a study to determine the precise contribution of Yervoy and if the risks associated with Yervoy can be further minimised.
Slovenian: Ker ni jasno, v kolikšni meri zdravilo Yervoy doprinese h koristim zdravljenja, kadar se uporablja v kombinaciji z nivolumabom pri bolnikih z napredovalim karcinomom ledvičnih celic, mora podjetje izvesti študijo za določitev natančnega doprinosa zdravila Yervoy in raziskati, ali je mogoče z njim povezana tveganja še dodatno zmanjšati.
English: In the treatment of melanoma, despite longer survival with a dose of 10 mg per kg, the Agency recommended using Yervoy at a dose of 3 mg per kg because the higher dose caused more side effects and worsened patients' quality of life after the start of treatment.
Slovenian: Pri zdravljenju melanoma je agencija kljub daljšemu preživetju pri odmerku 10 mg na kg telesne mase priporočila, naj se zdravilo Yervoy uporablja v odmerku 3 mg na kg telesne mase, saj je večji odmerek povzročil več neželenih učinkov in poslabšal kakovost življenja bolnikov po začetku zdravljenja.
English: Ipilimumab increases the number and the activity of a type of white blood cells called T cells which form part of the immune system and which can kill cancer cells.
Slovenian: Ipilimumab povečuje število in aktivnost vrste belih krvnih celic, imenovanih celice T, ki so del imunskega sistema in imajo sposobnost uničevanja rakavih celic.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Yervoy have also 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 Yervoy upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Because studies with Yervoy have included very few adolescents, the company has committed to collecting information on side effects, including any effects on growth and sexual maturation.
Slovenian: Ker so študije z zdravilom Yervoy vključevale zelo malo mladostnikov, se je podjetje zavezalo, da bo zbiralo informacije o neželenih učinkih, vključno z morebitnimi učinki na rast in spolno dozorevanje.
English: Because the medicine has been studied in very few adolescents, there is uncertainty about the medicine's side effects.
Slovenian: Ker so zdravilo proučevali pri zelo majhnem številu mladostnikov, obstaja negotovost glede njegovih neželenih učinkov.
English: Most will improve with appropriate treatment or on stopping Yervoy.
Slovenian: Večina učinkov izzveni z ustreznim zdravljenjem ali prekinitvijo uporabe zdravila Yervoy.
English: The company that markets Yervoy must ensure that all healthcare professionals expected to prescribe the medicine as well as patients are given a brochure with safety information on the medicine including the side effects resulting from excessive activity of the immune system.
Slovenian: Podjetje, ki trži zdravilo Yervoy, mora zagotoviti, da bodo vsi zdravstveni delavci, ki bodo predpisovali zdravilo, in vsi bolniki prejeli brošuro z informacijami o varnosti zdravila ter njegovih neželenih učinkih zaradi čezmernega delovanja imunskega sistema.
English: Yervoy is given by infusion (drip) into a vein over 90 minutes and the dose depends on the patient's body weight.
Slovenian: Zdravilo Yervoy se daje z 90-minutnim infundiranjem (kapalno infuzijo) v veno, pri čemer je odmerek odvisen od bolnikove telesne mase.
English: The most common side effects (which may affect more than 1 in 10 people) are diarrhoea, rash, itching, tiredness, nausea (feeling sick), vomiting, decreased appetite and abdominal pain (belly ache).
Slovenian: Najpogostejši neželeni učinki (ki se lahko pojavijo pri več kot 1 bolniku od 10) so driska, izpuščaj, srbenje, utrujenost, navzeja (siljenje na bruhanje), bruhanje, zmanjšan tek in abdominalne bolečine (bolečine v trebuhu).
English: However, patients treated with the higher dose had more side effects and were less likely to complete treatment as a result.
Slovenian: Vendar so imeli bolniki, ki so prejemali večji odmerek, več neželenih učinkov, zato je bilo pri njih verjetneje, da ne bodo mogli zaključiti zdravljenja.
English: The doctor may delay doses if certain side effects occur, and stop treatment altogether if side effects are severe.
Slovenian: Zdravnik bo morda odložil nadaljnje odmerke, če se pojavijo nekateri neželeni učinki, ali popolnoma prekinil zdravljenje, če so neželeni učinki resni.
English: For renal cell carcinoma, Yervoy is given to patients who have not been treated before and are at moderate or high risk of their cancer getting worse.
Slovenian: Pri zdravljenju karcinoma ledvičnih celic se zdravilo Yervoy daje bolnikom, ki predhodno še niso bili zdravljeni in so izpostavljeni zmernemu ali visokemu tveganju za poslabšanje rakavega obolenja.
English: However, about one-third of the patients could not complete Yervoy treatment due to side effects.
Slovenian: Približno tretjina bolnikov, ki so prejemali zdravilo Yervoy, pa zaradi neželenih učinkov ni mogla zaključiti zdravljenja.
English: The European Medicines Agency noted that Yervoy improves survival in melanoma, a condition where overall survival rates are low.
Slovenian: Evropska agencija za zdravila je menila, da zdravilo Yervoy izboljšuje preživetje pri bolnikih z melanomom, tj. boleznijo, za katero je značilna nizka celokupna stopnja preživetja.
English: The results showed that in patients at moderate or high risk of their cancer getting worse, patients given the combination lived overall longer than those given sunitinib.
Slovenian: Rezultati so pokazali, da so v skupini bolnikov z zmernim ali visokim tveganjem za poslabšanje rakavega obolenja, na splošno dlje časa živeli tisti, ki so prejemali omenjeno kombinacijo zdravil, kot tisti, ki so prejemali sunitinib.
English: Yervoy can only be obtained with a prescription and treatment should be started and supervised by a specialist doctor experienced in treating cancer.
Slovenian: Predpisovanje in izdaja zdravila Yervoy je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik specialist, ki ima izkušnje z zdravljenjem raka.
English: The active substance in Yervoy, ipilimumab, is a monoclonal antibody.
Slovenian: Učinkovina v zdravilu Yervoy, ipilimumab, je monoklonsko protitelo.
English: Yervoy is usually used in combination with another medicine, nivolumab, but can also be used on its own for melanoma.
Slovenian: Običajno se uporablja v kombinaciji z drugim zdravilom, nivolumabom, vendar se lahko pri zdravljenju melanoma uporablja tudi kot samostojno zdravilo.
English: The most frequent side effects of the medicine are mild to moderate in severity.
Slovenian: Večina pogostih neželenih učinkov zdravila je blagih do zmernih.
English: Yervoy is a cancer medicine used in adults and adolescents from 12 years of age with advanced melanoma (a type of skin cancer) and in adults with advanced renal cell carcinoma (a kidney cancer).
Slovenian: Yervoy je zdravilo za zdravljenje raka, ki se uporablja pri odraslih in mladostnikih, starejših od 12 let, z napredovalim melanomom (vrsto kožnega raka) in pri odraslih z napredovalim karcinomom ledvičnih celic (rakom ledvic).
English: Finally, two studies found the combination of Yervoy and nivolumab effective for treating advanced melanoma in adults who had not been treated previously, and whose cancer produced a protein called PD-L1.
Slovenian: V dveh študijah so ugotovili, da je kombinacija zdravila Yervoy in nivolumaba učinkovita pri zdravljenju napredovalega melanoma pri odraslih, ki se predhodno niso zdravili in pri katerih rak tvori beljakovino, imenovano PD-L1.
English: For the full list of side effects and restrictions with Yervoy, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Yervoy glejte navodilo za uporabo.
English: It acts on T cells by attaching to and blocking the activity of CTLA-4, a protein that controls the activity of T cells.
Slovenian: Na celice T vpliva tako, da se veže na beljakovino CTLA-4, ki nadzira delovanje teh celic, in zavira njeno delovanje.
English: In the treatment of advanced renal cell carcinoma, Yervoy in combination with nivolumab also increases patients' survival, and side effects are considered acceptable.
Slovenian: Pri zdravljenju napredovalega karcinoma ledvičnih celic je kombinacija zdravila Yervoy in nivolumaba podaljšala tudi obdobje preživetja bolnikov, neželeni učinki pa veljajo za sprejemljive.
English: After 24 months, 66.5% of patients given the combination were alive compared with 52.9% in the sunitinib group.
Slovenian: Po 24 mesecih je bilo živih 66,5 % bolnikov, ki so prejemali kombinacijo zdravil, v primerjavi z 52,9 % bolnikov v skupini, ki je prejemala sunitinib.
English: Yervoy is commonly associated with side effects resulting from excessive activity of the immune system, including severe reactions and inflammation.
Slovenian: Pri uporabi zdravila Yervoy se pogosto pojavljajo neželeni učinki, ki so posledica čezmernega delovanja imunskega sistema, vključno s hudimi reakcijami in vnetjem.
English: In two small studies involving a total of 30 adolescents aged 12 to 18 years with advanced melanoma, treatment with Yervoy produced similar levels of medicine in blood as in adults.
Slovenian: V dveh manjših študijah, ki sta skupaj vključevali 30 mladostnikov z napredovalim melanomom, starih od 12 do 18 let, je zdravilo Yervoy ustvarilo podobne ravni učinkovine v krvi kot pri odraslih.
English: In the second study involving 142 adults, the disease was controlled in 56% of patients receiving Yervoy and nivolumab compared with 9% of patients receiving Yervoy alone.
Slovenian: V drugi študiji, v kateri je sodelovalo 142 odraslih bolnikov, je bila bolezen obvladana pri 56 % bolnikov, ki so prejemali kombinacijo zdravila Yervoy in nivolumaba, in pri 9 % bolnikov, ki so prejemali samo zdravilo Yervoy.
English: When used with nivolumab, the patient receives a dose of Yervoy and of nivolumab every 3 weeks for 4 doses followed by treatment with nivolumab alone.
Slovenian: Pri uporabi v kombinaciji z nivolumabom bolnik prejme odmerek zdravila Yervoy in nivolumaba vsake tri tedne, in sicer skupno štiri odmerke, temu pa sledi zdravljenje samo z nivolumabom.
English: When Yervoy is used alone, the patient receives a dose every 3 weeks for a total of 4 doses.
Slovenian: Če se zdravilo Yervoy uporablja kot samostojno zdravilo, bolnik prejme odmerek vsake tri tedne, in sicer skupno štiri odmerke.
English: A monoclonal antibody is a type of protein that has been designed to recognise and attach to a specific target in the body.
Slovenian: To je vrsta beljakovine, ki je bila zasnovana tako, da v telesu prepozna določeno prijemališče in se veže nanj.
English: Several other studies involving previously untreated adults found that patients treated with Yervoy at 3 mg per kg lived for 13.5 months on average.
Slovenian: V več drugih študijah, v katere so bili vključeni predhodno nezdravljeni odrasli bolniki, so ugotovili, da so bolniki, zdravljeni z zdravilom Yervoy v odmerku 3 mg na kg telesne mase, v povprečju živeli 13,5 meseca.
English: In the first of these studies involving 945 adults, patients treated with Yervoy and nivolumab lived for 11.7 months on average without their disease getting worse compared with 6.9 months for those treated with nivolumab alone and 2.9 months for those treated with Yervoy alone.
Slovenian: V prvi od teh dveh študij, v kateri je sodelovalo 945 odraslih bolnikov, so bolniki, zdravljeni z zdravilom Yervoy in nivolumabom, živeli brez poslabšanja bolezni v povprečju 11,7 meseca, medtem ko je bilo to obdobje pri bolnikih, zdravljenih samo z nivolumabom, 6,9 meseca, pri bolnikih, zdravljenih samo z zdravilom Yervoy, pa 2,9 meseca.
English: Additional common side effects when Yervoy is used with nivolumab include fever, reduced or increased levels of thyroid hormones, colitis (inflammation of the lower gut), joint pain, headache and breathing difficulty.
Slovenian: Drugi pogosti neželeni učinki uporabe zdravila Yervoy v kombinaciji z nivolumabom so zvišana telesna temperatura, znižane ali zvišane ravni ščitničnih hormonov, kolitis (vnetje spodnjih prebavil), bolečine v sklepih, glavobol in oteženo dihanje.
English: In a study involving 676 adults in whom previous treatment for advanced melanoma had not worked or had stopped working, overall survival with Yervoy combined with an experimental medicine called ‘gp100' was 10 months, compared with 6 months in patients receiving gp100 alone.
Slovenian: V študiji, v katero je bilo vključenih 676 odraslih bolnikov, pri katerih predhodno zdravljenje napredovalega melanoma ni bilo učinkovito ali je prenehalo učinkovati, je bilo celokupno preživetje pri uporabi zdravila Yervoy v kombinaciji s poskusnim zdravilom, imenovanim „gp100“, deset mesecev v primerjavi s šestimi meseci pri bolnikih, ki so prejemali samo gp100.
English: One main study involving 1,096 adults with previously untreated advanced renal cell carcinoma compared treatment with Yervoy and nivolumab versus treatment with another cancer medicine for renal cell carcinoma, sunitinib.
Slovenian: V glavni študiji, v katero je bilo vključenih 1 096 odraslih bolnikov s predhodno nezdravljenim napredovalim karcinomom ledvičnih celic, so zdravljenje s kombinacijo zdravila Yervoy in nivolumaba primerjali z drugim zdravilom za zdravljenje karcinoma ledvičnih celic, sunitinibom.
English: How does Yervoy work?
Slovenian: Kako zdravilo Yervoy deluje?
English: How is Yervoy used?
Slovenian: Kako se zdravilo Yervoy uporablja?
English: In a study involving 727 adults with advanced melanoma, patients treated with Yervoy 3 mg per kg lived for around 12 months on average compared with 16 months for those treated with 10 mg per kg.
Slovenian: V študiji, v katero je bilo vključenih 727 odraslih bolnikov z napredovalim melanomom, so bolniki, zdravljeni z zdravilom Yervoy v odmerku 3 mg na kg telesne mase, v povprečju živeli približno 12 mesecev, medtem ko so bolniki, ki so prejemali odmerek 10 mg na kg telesne mase, živeli približno 16 mesecev.
English: In a study involving 502 adults whose advanced melanoma had not been treated previously, patients treated with high-dose Yervoy and dacarbazine lived for 11 months on average, compared with 9 months for those given placebo (a dummy treatment) plus dacarbazine.
Slovenian: V študiji, v katero sta bila vključena 502 odrasla bolnika z napredovalim melanomom, ki predhodno nista bila zdravljena, so bolniki, ki so prejemali visok odmerek zdravila Yervoy in dakarbazina, povprečno živeli 11 mesecev v primerjavi z devetimi meseci pri bolnikih, ki so prejemali kombinacijo placeba (zdravila brez učinkovine) in dakarbazina.
English: The time patients lived before their disease got worse was 11.6 months with the combination compared with 8.4 with sunitinib.
Slovenian: Čas do poslabšanja bolezni je bil 11,6 meseca v skupini, ki je prejemala kombinacijo zdravil, v skupini bolnikov, ki so prejemali sunitinib, pa 8,4 meseca.
English: Yervoy contains the active substance ipilimumab.
Slovenian: Zdravilo Yervoy vsebuje učinkovino ipilimumab.
English: The effectiveness of the vaccine was first studied in a number of laboratory studies in pigs.
Slovenian: Učinkovitost cepiva so najprej proučevali v več laboratorijskih študijah na prašičih.
English: Affected pigs often have a cough and fail to thrive.
Slovenian: Oboleli prašiči pogosto kašljajo in se ne razvijajo.
English: Protection starts three weeks after vaccination and lasts for 23 weeks after vaccination.
Slovenian: Zaščita se začne tri tedne po cepljenju in traja 23 tednov po cepljenju.
English: What are the precautions for the person who gives the medicine or comes into contact with the animal?
Slovenian: Kakšne previdnostne ukrepe mora upoštevati oseba, ki daje zdravilo ali pride v stik z čivaljo?
English: In the future, if the animals are exposed to the virus or the bacteria the immune system will be able to respond more quickly.
Slovenian: Ob ponovni izpostavitvi čivali virusu ali bakteriji v prihodnosti se bo imunski sistem tako hitreje odzval.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Suvaxyn Circo+MH RTU's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Suvaxyn Circo+MH RTU večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: The full EPAR for Suvaxyn Circo+MH RTU can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila Suvaxyn Circo+MH RTU je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Swelling, less than 2 cm in diameter, heat, redness at the injection site and pain to the touch which may last up to 2 days were also seen.
Slovenian: Opačeni so bili tudi otekanje, v premeru manj kot 2 cm, vroč ina in rdečina na mestu injiciranja ter bolečina na dotik, ki lahko traja do dva dni.
English: What is the withdrawal period in food-producing animals?
Slovenian: Kako dolgo traja karenca pri čivalih, namenjenih za proizvodnjo hrane?