FrancophonIA/ELRC3.0 huggingface dataset:
English: The main measure of effectiveness was how long patients could exercise on a bicycle or a treadmill, which was measured at the start and the end of each study.
Slovenian: Glavno merilo učinkovitosti je bilo, koliko časa so bolniki zdržali pri vadbi na sobnem kolesu ali tekaški stezi, merjeno na začetku in ob koncu vsake študije.
English: The main measure of effectiveness was a reduction in the risk of death due to heart problems and non-fatal heart attack.
Slovenian: Glavno merilo učinkovitosti je bilo zmanjšanje tveganja smrtnega izida zaradi težav s srcem in srčnih napadov brez smrtnega izida.
English: Other information about Corlentor
Slovenian: Druge informacije o zdravilu Corlentor
English: In stable angina, these symptoms appear during physical effort.
Slovenian: Pri stabilni angini pektoris se ti simptomi pojavijo med telesnim naporom.
English: The Agency decided that Corlentor's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Zato je zaključila, da so koristi zdravila Corlentor večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Corlentor 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 Corlentor upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: However, a fifth study in 728 patients showed that adding Corlentor to amlodipine did not provide an additional benefit.
Slovenian: V peti študiji s 728 bolniki pa so dokazali, da dodajanje zdravila Corlentor amlodipinu ne prinaša dodatnih koristi.
English: As for all medicines, data on the use of Corlentor are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Corlentor stalno spremljajo.
English: An overview of Corlentor and why it is authorised in the EU
Slovenian: Pregled zdravila Corlentor in zakaj je odobreno v EU
English: Side effects reported with Corlentor are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Corlentor, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: What benefits of Corlentor have been shown in studies?
Slovenian: Kakšne koristi zdravila Corlentor so se pokazale v študijah?
English: Corlentor therefore reduces or prevents the symptoms of angina.
Slovenian: Zdravilo Corlentor tako zmanjša ali prepreči simptome angine pektoris.
English: Why is Corlentor authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Corlentor odobreno v EU?
English: The recommended starting dose is 5 mg twice a day with meals, which the doctor may increase to 7.5 mg twice a day or decrease to 2.5 mg (half a 5-mg tablet) twice a day depending on the patient's heart rate and symptoms.
Slovenian: Priporočeni začetni odmerek je 5 mg dvakrat na dan med obroki, ki ga lahko zdravnik poveča na 7,5 mg dvakrat na dan ali zmanjša na 2,5 mg (pol 5-miligramske tablete) dvakrat na dan, odvisno od bolnikovega srčnega utripa in simptomov.
English: Corlentor is available as tablets (5 and 7.5 mg) and it can only be obtained with a prescription.
Slovenian: Zdravilo Corlentor je na voljo v obliki tablet (5 in 7,5 mg), njegovo predpisovanje in izdaja pa je le na recept.
English: For more information about using Corlentor, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Corlentor glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Angina
Slovenian: Angina pektoris
English: In a fourth study in 889 patients, Corlentor was more effective than placebo, when both were added to atenolol.
Slovenian: V četrti študiji z 889 bolniki je bilo zdravilo Corlentor učinkovitejše od placeba, pri čemer so oba dodajali atenololu.
English: Results showed that Corlentor was more effective than placebo at preventing death due to disease of the heart or blood vessels or hospitalisation due to worsening heart failure: 24.5% (793 out of 3,241) of patients treated with Corlentor died or were hospitalised due to worsening heart failure, compared with 28.7% (937 out of 3,264) of patients receiving placebo.
Slovenian: Rezultati so pokazali, da je zdravilo Corlentor učinkovitejše od placeba pri preprečevanju smrti zaradi bolezni srca ali ožilja oziroma hospitalizacije zaradi poslabšanja srčnega popuščanja: 24,5 % (793 od 3 241) bolnikov, ki so bili zdravljeni z zdravilom Corlentor, je umrlo ali je bilo hospitaliziranih zaradi poslabšanja srčnega popuščanja v primerjavi z 28,7 % (937 od 3 264) bolnikov, ki so bili zdravljeni s placebom.
English: When used for angina, treatment should be stopped if symptoms do not improve after 3 months.
Slovenian: Pri angini pektoris je treba zdravljenje prekiniti, če po treh mesecih ne pride do izboljšanja simptomov.
English: When these currents are blocked, the heart rate is lowered, so that the heart has less work to do and needs less oxygenated blood.
Slovenian: Z zaviranjem teh tokov upočasni srčni utrip, tako da ima srce manj dela in potrebuje manj krvi s kisikom.
English: Bradycardia (slow heart rate) is common (it may affect up to 1 in 10 people).
Slovenian: Bradikardija (upočasnjen srčni utrip) je pogosta (pojavi se lahko pri največ 1 bolniku od 10).
English: What are the risks associated with Corlentor?
Slovenian: Kakšna tveganja so povezana z zdravilom Corlentor?
English: The most common side effect with Corlentor ( which may affect more than 1 in 10 people) is luminous phenomena or ‘phosphenes' (a temporary brightness in the field of vision).
Slovenian: Najpogostejši neželeni učinek zdravila Corlentor (ki se lahko pojavi pri več kot 1 bolniku od 10 ) so pojavi svetlikanja ali „fosfeni“ (prehodno povečanje svetlosti v vidnem polju).
English: Also, the doctor should consider stopping treatment if the medicine has only a limited effect on reducing angina symptoms or reducing the heart rate within 3 months.
Slovenian: Zdravnik mora prav tako razmisliti o prekinitvi zdravljenja, če ima zdravilo v treh mesecih le omejen učinek na zmanjšanje simptomov angine pektoris ali zniževanje srčnega utripa.
English: What is Corlentor and what is it used for?
Slovenian: Kaj je zdravilo Corlentor in za kaj se uporablja?
English: Corlentor must not be used in patients who have a resting heart rate below 70 beats per minute, very low blood pressure, various types of heart disorder (including cardiogenic shock, rhythm disorders, heart attack, unstable or acute (sudden) heart failure and unstable angina) or severe liver problems.
Slovenian: Zdravila Corlentor ne smejo jemati bolniki, ki imajo srčni utrip med mirovanjem nižji od 70 utripov na minuto, zelo nizek krvni tlak, razne vrste obolenj srca (npr. kardiogeni šok, motnje ritma, srčni napad, nestabilno ali akutno (nenadno) srčno popuščanje in nestabilno angino pektoris) ali hude težave z jetri.
English: The European Medicines Agency concluded that Corlentor was shown to be effective in long-term angina with an acceptable safety profile for it to provide an alternative treatment for patients who cannot take beta blockers or whose disease is not controlled with them.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo za zdravilo Corlentor dokazano, da je učinkovito pri zdravljenju kronične angine pektoris in ima sprejemljiv varnostni profil za nadomestno zdravljenje bolnikov, ki ne morejo jemati zaviralcev receptorjev beta oziroma katerih bolezen ni urejena z njimi.
English: In this study, a specific subgroup of patients who had symptomatic angina had a small but significant increase in the combined risk of cardiovascular death or non-fatal heart attack with Corlentor compared with placebo (3.4% vs 2.9% yearly incidence rates).
Slovenian: V tej študiji je pri posebni podskupini bolnikov s simptomatsko angino pektoris, zdravljenih z zdravilom Corlentor, prišlo do majhnega, vendar pomembnega zmanjšanja združenega tveganja smrti zaradi srčno-žilne bolezni ali srčnega napada brez smrtnega izida v primerjavi s placebom (letni delež pogostnosti 3,4 % v primerjavi z 2,9 %).
English: A sixth study compared Corlentor with placebo in 19,102 patients with coronary artery disease and without clinical heart failure.
Slovenian: V šesti študiji so zdravilo Corlentor primerjali s placebom pri 19 102 bolnikih z boleznijo koronarnih arterij brez kliničnega srčnega popuščanja.
English: Corlentor contains the active substance ivabradine.
Slovenian: Zdravilo Corlentor vsebuje zdravilno učinkovino ivabradin.
English: Corlentor is a heart medicine used to treat the symptoms of long-term stable angina (pains to the chest, jaw and back, brought on by physical effort) in adults with coronary artery disease (disease of the heart caused by the obstruction of the blood vessels that supply blood to the heart muscle).
Slovenian: Corlentor je zdravilo za srce, ki se uporablja za zdravljenje simptomov kronične stabilne angine pektoris (bolečin v prsih, čeljusti in hrbtu zaradi telesnega napora) pri odraslih z boleznijo koronarnih arterij (boleznijo srca, ki jo povzroča zapora v krvnih žilah, ki oskrbujejo srčno mišico).
English: Further information on Corlentor can be found on the Agency's website: https://www.ema.europa.eu/en/medicines/human/EPAR/corlentor
Slovenian: Več informacij o zdravilu Corlentor je na voljo na spletni strani agencije: https://www.ema.europa.eu/en/medicines/human/EPAR/corlentor Pregled je bil nazadnje posodobljen 11-2018.
English: It was as effective as atenolol (a beta blocker) in a study of 939 patients and as effective as amlodipine (another medicine used to treat angina) in a study of 1,195 patients.
Slovenian: V študiji z 939 bolniki je bilo enako učinkovito kot atenolol (zaviralec receptorjev beta), v študiji s 1 195 bolniki pa enako učinkovito kot amlodipin (drugo zdravilo za zdravljenje angine pektoris).
English: Corlentor was compared with placebo (a dummy treatment) and other treatments in five main studies involving over 4,000 adults with long-term stable angina.
Slovenian: Zdravilo Corlentor so primerjali s placebom (zdravilom brez zdravilne učinkovine) in drugimi zdravili v petih glavnih študijah, v katere je bilo vključenih več kot 4 000 odraslih s kronično stabilno angino pektoris.
English: It also concluded that Corlentor was effective in long-term heart failure with an acceptable safety profile.
Slovenian: Prav tako je zaključila, da je zdravilo Corlentor učinkovito pri zdravljenju kroničnega srčnega popuščanja in ima sprejemljiv varnostni profil.
English: Corlentor is also used in patients with long-term heart failure (when the heart cannot pump enough blood to the rest of the body) who have a normal heart rhythm and whose heart rate is at least 75 beats per minute.
Slovenian: Zdravilo Corlentor se uporablja tudi pri bolnikih s kroničnim srčnim popuščanjem (kadar srce ne more načrpati dovolj krvi po telesu), ki imajo sicer normalen srčni ritem, a je njihov srčni utrip najmanj 75 utripov na minuto.
English: The medicine is used in patients who have a normal heart rhythm, and whose heart rate is at least 70 beats per minute.
Slovenian: Zdravilo se uporablja pri bolnikih z normalnim srčnim ritmom, katerih srčni utrip je vsaj 70 utripov na minuto.
English: It is used in combination with standard therapy including beta blockers, or in patients who cannot be treated with beta blockers.
Slovenian: Uporablja se v kombinaciji s standardnim zdravljenjem, ki vključuje zaviralce receptorjev beta, ali pri bolnikih, ki teh zaviralcev ne smejo jemati.
English: Corlentor was compared with placebo in one main study involving over 6,500 patients with long-term moderate to severe heart failure.
Slovenian: Zdravilo Corlentor so primerjali s placebom v eni glavni študiji, v katero je bilo vključenih več kot 6 500 bolnikov s kroničnim zmernim do hudim srčnim popuščanjem.
English: The symptoms of heart failure are caused by the heart not pumping enough blood around the body.
Slovenian: Do simptomov srčnega popuščanja pride takrat, ko srce ne more črpati dovolj krvi po telesu.
English: How does Corlentor work?
Slovenian: Kako zdravilo Corlentor deluje?
English: By lowering the heart rate, Corlentor reduces the stress on the heart, thereby slowing the progression of heart failure and improving symptoms.
Slovenian: Zdravilo Corlentor z zniževanjem srčnega utripa zmanjša obremenitev srca ter upočasni napredovanje srčnega popuščanja in ublaži simptome.
English: The active substance in Corlentor, ivabradine, works by blocking the ‘If currents' in the sinus node, the ‘pacemaker' for the heart that controls the heart's contractions and regulates the heart rate.
Slovenian: Zdravilna učinkovina v zdravilu Corlentor, ivabradin, deluje tako, da zavira „tokove If“ v sinusnem vozlu, tj. spodbujevalniku srca, ki nadzoruje krčenje srca in uravnava srčni utrip.
English: It is used in those who cannot be treated with beta blockers (another type of medicine to treat angina) or in combination with a beta blocker in patients whose disease is not controlled by beta blockers alone.
Slovenian: Uporablja se pri bolnikih, ki ne morejo jemati zaviralcev receptorjev beta (druge vrste zdravila za zdravljenje angine pektoris), oziroma v kombinaciji z zaviralci receptorjev beta pri bolnikih, pri katerih bolezen samo z jemanjem zaviralcev receptorjev beta ni urejena.
English: How is Corlentor used?
Slovenian: Kako se zdravilo Corlentor uporablja?
English: Results showed that the medicine was more effective than placebo in one of the studies in 360 patients.
Slovenian: Rezultati ene študije s 360 bolniki so pokazali, da je zdravilo učinkovitejše od placeba.
English: For the full list of all side effects reported with Corlentor, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Corlentor, glejte navodilo za uporabo.
English: The symptoms of angina are caused by the heart not receiving enough oxygenated blood.
Slovenian: Simptome angine pektoris povzroča premajhen dotok krvi s kisikom v srce.
English: For the full list of restrictions with Corlentor, see the package leaflet.
Slovenian: Za celoten seznam omejitev pri uporabi zdravila Corlentor glejte navodilo za uporabo.
English: For the treatment of angina, Corlentor was originally authorised for patients whose heart rate is at least 60 beats per minute.
Slovenian: Zdravilo Corlentor je bilo za zdravljenje angine pektoris prvotno odobreno za uporabo pri bolnikih s srčnim utripom vsaj 60 utripov na minuto, vendar je bila pozneje njegova uporaba omejena zgolj na bolnike s srčnim utripom vsaj 70 utripov na minuto.1
English: Treatment must be stopped if the heart rate is persistently below 50 beats per minute or if symptoms of bradycardia (slow heart rate) continue despite dose reduction.
Slovenian: Pri bolnikih, starejših od 75 let, se lahko uporabi manjši začetni odmerek 2,5 mg dvakrat na dan. Zdravljenje je treba prekiniti, če srčni utrip stalno pada pod 50 utripov na minuto ali če se nadaljujejo simptomi bradikardije (počasnega srčnega utripa).
English: 25 May 2012
Slovenian: 25. maj 2012
English: International non-proprietary name (inn): doramectin
Slovenian: Mednarodno nelastniško ime (INN): doramektin
English: Written explanations were provided by the applicant on 13 September 2011 and 11 January 2012.
Slovenian: Predlagatelj je pisna pojasnila predložil 13. septembra 2011 in 11 januarja 2012.
English: The final opinion was converted into a Decision by the European Commission on 25 May 2012.
Slovenian: Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 25. maja 2012.
English: The Committee appointed Dr Michael Holzhauser-Alberti as rapporteur and Dr David Murphy as co-rapporteur.
Slovenian: Odbor je za poročevalca imenoval dr. Michaela Holzhauser-Albertija, za soporočevalca pa dr. Davida Murphyja.
English: The decentralised procedure started on 26 February 2010.
Slovenian: Decentralizirani postopek se je začel 26. februarja 2010.
English: Both compounds share a wide spectrum of antiparasitic activity and produce a similar paralysis in nematodes and parasitic arthropods.
Slovenian: Obe spojini imata širok spekter protiparazitskega delovanja in povzročata podobno paralizo pri nematodih in parazitskih artropodih.
English: Article 33(4) of Directive 2001/82/EC, as amended
Slovenian: Člen 33(4) Direktive 2001/82/ES, kakor je bila spremenjena.
English: The referral procedure started on 5 May 2011.
Slovenian: Napotitveni postopek se je začel 5. maja 2011.
English: Doramectin is a macrocyclic lactone and is closely related to ivermectin.
Slovenian: Doramektin je makrociklični lakton in je zelo podoben ivermektinu.
English: Veterinary Medicines and Product Data Management
Slovenian: Zdravila za uporabo v veterinarski medicini in upravljanje podatkov o zdravilu
English: Potential serious risks were identified during the decentralised procedure by two concerned Member States regarding the environmental risk assessment (the Netherlands and France) and regarding the proposed withdrawal period for cattle (the Netherlands).
Slovenian: V okviru decentraliziranega postopka sta dve zadevni državi članici opredelili morebitna resna tveganja glede ocene tveganja za okolje (Nizozemska in Francija) in predlaganega obdobja karence za govedo (Nizozemska).
English: The application was submitted to Ireland as reference Member State and Austria, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Greece, Spain, Finland, France, Hungary, Latvia, Lithuania, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia and Sweden as concerned Member States, as well as Iceland and Norway.
Slovenian: Predlagatelj, družba Pfizer Limited, je predložil vlogo za začetek decentraliziranega postopka za zgoraj omenjeno zdravilo za uporabo v veterinarski medicini v okviru člena 32 Direktive 2001/82/ES, kakor je bila spremenjena Vloga je bila predložena Irski kot referenčni državi članici, Avstriji, Bolgariji, Cipru, Češki republiki, Danski, Estoniji, Grčiji, Španiji, Finski, Franciji, Madžarski, Latviji, Litvi, Malti, Nizozemski, Poljski, Portugalski, Romuniji, Slovaški, Sloveniji in Švedski kot zadevnim državam članicam ter Islandiji in Norveški.
English: On 26 April 2011 the reference Member State, Ireland, referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC.
Slovenian: Irska je kot referenčna država članica 26. aprila 2011 v skladu s členom 33(4) Direktive 2001/82/ES zadevo napotila na odbor CVMP.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amendments to the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State in the Annex III.
Slovenian: Seznam zadevnih imen zdravil je naveden v Dodatku I. Znanstveni zaključki so podani v Dodatku II, dopolnjen povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo v referenčni državi članici pa v Dodatku III.
English: Based on evaluation of the currently available data, the CVMP considered that the benefit-risk profile of Prontax 10 mg/ml solution for injection for cattle, sheep and pigs and associated names is deemed to be positive provided that the recommended risk mitigation measures are added to the product information regarding risk to aquatic organisms and dung fauna and the withdrawal period for meat and offal in cattle is set at 70 days.
Slovenian: Na podlagi ocene trenutno razpoložljivih podatkov je odbor CVMP presodil, da razmerje med koristmi in tveganji za zdravilo Prontax 10 mg/ml, raztopina za injiciranje za govedo, ovce in prašiče, in povezana imena, velja za pozitivno, če so informacijam o zdravilu dodani priporočeni ukrepi za zmanjšanje tveganja v zvezi s tveganjem za vodne organizme in organizme, prisotne v gnoju, ter če je obdobje karence za goveje meso in drobovino 70 dni.
English: Therefore, CVMP adopted a positive opinion on 8 February 2012 recommending the granting of a Marketing Authorisation for Prontax 10 mg/ml solution for injection for cattle, sheep and pigs and associated names.
Slovenian: Odbor CVMP je zato 8. februarja 2012 sprejel pozitivno mnenje, v katerem priporoča odobritev dovoljenja za promet z zdravilom Prontax 10 mg/ml, raztopina za injiciranje za govedo, ovce in prašiče, in povezana imena.
English: Prontax 10 mg/ml solution for injection for cattle, sheep and pigs (and associated names) contains doramectin.
Slovenian: Zdravilo Prontax 10 mg/ml, raztopina za injiciranje za govedo, ovce in prašiče (in povezana imena) vsebuje doramektin.
English: Opinion following an Article 33(4)F F referral for Prontax 10 mg/ml solution for injection for cattle, sheep and pigs and associated names EMA/281970/2012
Slovenian: Mnenje v zvezi z napotitvijo v skladu s členom 33(4)F F za zdravilo Prontax 10 mg/ml, raztopina za injiciranje za govedo, ovce in prašiče, in povezana imena EMA/421497/2012
English: referral for Prontax 10 mg/ml solution for injection for cattle, sheep and pigs and associated names
Slovenian: za zdravilo Prontax 10 mg/ml, raztopina za injiciranje za govedo, ovce in prašiče, in povezana imena
English: Cerezyme imiglucerase
Slovenian: Cerezyme imigluceraza
English: This is an acceptable number because the disease is rare.
Slovenian: To število bolnikov je sprejemljivo, saj gre za zelo redko bolezen.
English: After training, the patient or carer can give the infusion at home, if their doctor believes it is appropriate.
Slovenian: Po usposabljanju lahko bolnik ali negovalec zdravilo infundira doma, če zdravnik meni, da je to ustrezno.
English: The patients must have symptoms that are not affecting the nervous system, including one or more of the following conditions:
Slovenian: Bolniki morajo imeti simptome, ki ne vplivajo na živčni sistem, vključno z enim ali več naslednjih stanj:
English: Cerezyme is usually given by infusion every two weeks.
Slovenian: Zdravilo Cerezyme se običajno daje z infuzijo vsaka dva tedna.
English: • an enlarged liver or spleen.
Slovenian: • povečanimi jetri ali vranico.
English: Other information about Cerezyme:
Slovenian: Druge informacije o zdravilu Cerezyme:
English: The first few infusions should be given slowly, but after these, the speed of infusion can be increased under the supervision of a doctor or nurse.
Slovenian: Prvih nekaj infuzij je treba dati počasi, hitrost dajanja vseh nadaljnjih infuzij pa se lahko nato poveča pod nadzorom zdravnika ali medicinske sestre.
English: For more information about treatment with Cerezyme, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Cerezyme preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: This document is a summary of the European public assessment report (EPAR) for Cerezyme.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Cerezyme.
English: The dose and how often the infusions are given need to be adjusted according to each individual patient's symptoms and response to treatment.
Slovenian: Odmerek in pogostost dajanja infuzij je treba prilagoditi glede na posameznikove simptome in odziv na zdravljenje.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cerezyme to Genzyme Europe B.V. on 17 November 1997.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Cerezyme, veljavno po vsej Evropski uniji, odobrila družbi Genzyme Europe B.V.
English: The Committee decided that Cerezyme's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor je zaključil, da so koristi zdravila Cerezyme večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.