FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Corlentor nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Side effects reported with Corlentor are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Corlentor pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
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.
Croatian: U slučaju kada su ovi kanali blokirani, srčana se frekvencija smanjuje, tako da srce mora manje raditi i potrebno mu je manje oksigenirane krvi.
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).
Croatian: Najčešća su nuspojava lijeka Corlentor (koja se može javiti u više od 1 na 10 osoba) svjetlosni fenomeni ili „fosfeni” (privremena svjetlost u vidnom polju).
English: When used for angina, treatment should be stopped if symptoms do not improve after 3 months.
Croatian: Pri liječenju angine terapiju treba prekinuti ako se simptomi ne ublaže nakon tri mjeseca.
English: Corlentor is available as tablets (5 and 7.5 mg) and it can only be obtained with a prescription.
Croatian: Lijek Corlentor dostupan je u obliku tableta (od 5 i 7,5 mg) i izdaje se samo na liječnički recept.
English: As for all medicines, data on the use of Corlentor are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Corlentor kontinuirano se prate.
English: An overview of Corlentor and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Corlentor i zašto je odobren u EU-u
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.
Croatian: Rezultati su pokazali da je Corlentor djelotvorniji od placeba u sprječavanju smrti zbog bolesti srca ili krvnih žila ili hospitalizacije zbog pogoršanog zatajenja srca: od bolesnika liječenih lijekom Corlentor, 24,5 % (793 od 3241) umrlo je ili je bilo hospitalizirano zbog pogoršanja zatajenja srca, u usporedbi s 28,7 % (937 od 3264) bolesnika koji su primali placebo.
English: Corlentor contains the active substance ivabradine.
Croatian: Corlentor sadrži djelatnu tvar ivabradin.
English: The symptoms of angina are caused by the heart not receiving enough oxygenated blood.
Croatian: Simptome angine uzrokuje stanje pri kojem srce ne prima dovoljno oksigenirane krvi.
English: Why is Corlentor authorised in the EU?
Croatian: Zašto je lijek Corlentor odobren u EU-u?
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.
Croatian: Bio je jednako djelotvoran kao atenolol (beta blokator) u ispitivanju na 939 bolesnika, te jednako djelotvoran kao amlodipin (drugi lijek za liječenje angine) u ispitivanju na 1195 bolesnika.
English: What are the risks associated with Corlentor?
Croatian: Koji su rizici povezani s lijekom Corlentor?
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.
Croatian: Corlentor se ne smije primjenjivati u bolesnika koji imaju srčanu frekvenciju u mirovanju manju od 70 otkucaja u minuti, vrlo nizak krvni tlak, različite tipove srčanog poremećaja (uključujući kardiogeni šok, poremećaj ritma, infarkt miokarda, nestabilno ili akutno (iznenadno) zatajenje srca i nestabilnu anginu) ili ozbiljne probleme s jetrom.
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).
Croatian: U tom je ispitivanju posebna podskupina bolesnika sa simptomatskom anginom imala malo, ali značajno povećanje kombiniranog rizika od kardiovaskularne smrti ili nesmrtonosnog srčanog udara pri primjeni lijeka Corlentor u usporedbi s placebom (godišnje stope incidencije od 3,4 % odnosno 2,9 %).
English: By lowering the heart rate, Corlentor reduces the stress on the heart, thereby slowing the progression of heart failure and improving symptoms.
Croatian: Snižavanjem srčane frekvencije Corlentor ublažava napor za srce te stoga usporava napredak zatajenja srca i poboljšava simptome.
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.
Croatian: Europska agencija za lijekove zaključila je da je dokazano kako je lijek Corlentor djelotvoran u liječenju kronične angine, uz prihvatljiv sigurnosni profil, kako bi osigurao alternativno liječenje za bolesnike koji ne mogu uzimati beta blokatore ili čija se bolest njima ne može kontrolirati.
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.
Croatian: Liječenje se mora prekinuti ako je srčana frekvencija kontinuirano niža od 50 otkucaja u minuti ili ako se unatoč smanjenju doze nastave simptomi bradikardije (niska srčana frekvencija).
English: A sixth study compared Corlentor with placebo in 19,102 patients with coronary artery disease and without clinical heart failure.
Croatian: U šestom ispitivanju lijek Corlentor uspoređen je s placebom u 19 102 bolesnika s koronarnom arterijskom bolesti i bez kliničkog zatajenja srca.
English: It also concluded that Corlentor was effective in long-term heart failure with an acceptable safety profile.
Croatian: Također je zaključila da je Corlentor djelotvoran u liječenju kroničnog zatajenja srca, uz prihvatljiv sigurnosni profil.
English: For the treatment of angina, Corlentor was originally authorised for patients whose heart rate is at least 60 beats per minute.
Croatian: Za liječenje angine Corlentor je izvorno odobren za bolesnike čija je srčana frekvencija barem 60 otkucaja u minuti.
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).
Croatian: Corlentor je lijek za srce koji se primjenjuje za simptomatsko liječenje kronične stabilne angine (bolovi u prsima, čeljusti i leđima uzrokovani fizičkim naporom) u odraslih osoba s koronarnom arterijskom bolesti (bolest srca uzrokovana opstrukcijom krvnih žila koje opskrbljuju srčani mišić krvlju).
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.
Croatian: Lijek Corlentor uspoređen je s placebom (prividno liječenje) i drugim terapijama u pet glavnih ispitivanja koja su obuhvatila više od 4000 odraslih osoba s kroničnom stabilnom anginom.
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.
Croatian: Corlentor se također primjenjuje u bolesnika s kroničnim zatajenjem srca (kada srce ne može opskrbljivati ostatak tijela s dovoljno krvi) koji imaju normalni srčani ritam i čija je srčana frekvencija najmanje 75 otkucaja u minuti.
English: The Agency decided that Corlentor's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Agencija je zaključila da koristi lijeka Corlentor nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
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.
Croatian: Primjenjuje se u bolesnika koji se ne mogu liječiti beta blokatorima (druga vrsta lijeka za liječenje angine) ili u kombinaciji s beta blokatorima u bolesnika čiju se bolest ne može kontrolirati samo beta blokatorima.
English: How does Corlentor work?
Croatian: Kako djeluje Corlentor?
English: It is used in combination with standard therapy including beta blockers, or in patients who cannot be treated with beta blockers.
Croatian: Primjenjuje se u kombinaciji sa standardnom terapijom koja uključuje beta blokatore ili u bolesnika koji se ne mogu liječiti beta blokatorima.
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.
Croatian: Nadalje, liječnik treba razmotriti prekid terapije ako lijek nakon tri mjeseca primjene samo ograničeno djeluje na ublažavanje simptoma angine ili smanjenje srčane frekvencije.
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.
Croatian: Djelatna tvar u lijeku Corlentor, ivabradin, djeluje inhibirajući „If kanale” u sinusnom čvoru, „elektrostimulatoru” srca koji kontrolira kontrakcije srca i regulira srčanu frekvenciju.
English: What benefits of Corlentor have been shown in studies?
Croatian: Koje su koristi lijeka Corlentor dokazane u ispitivanjima?
English: How is Corlentor used?
Croatian: Kako se Corlentor koristi?
English: In a fourth study in 889 patients, Corlentor was more effective than placebo, when both were added to atenolol.
Croatian: U četvrtom ispitivanju na 889 bolesnika kombinacija lijeka Corlentor i atenolola bila je djelotvornija od kombinacije placeba i atenolola.
English: Corlentor was compared with placebo in one main study involving over 6,500 patients with long-term moderate to severe heart failure.
Croatian: Lijek Corlentor uspoređen je s placebom u jednom glavnom ispitivanju koje je uključivalo više od 6500 bolesnika s kroničnim umjerenim do ozbiljnim zatajenjem srca.
English: However, the use was later restricted to patients whose heart rate is at least 70 beats per minute.1
Croatian: Međutim, to je naknadno ograničeno na bolesnike čija je srčana frekvencija barem 70 otkucaja u minuti.1
English: The medicine is used in patients who have a normal heart rhythm, and whose heart rate is at least 70 beats per minute.
Croatian: Lijek se primjenjuje u bolesnika s normalnim srčanim ritmom i sa srčanom frekvencijom od najmanje 70 otkucaja u minuti.
English: The symptoms of heart failure are caused by the heart not pumping enough blood around the body.
Croatian: Do simptoma zatajenja srca dolazi kada srce ne opskrbljuje tijelo dovoljnom količinom krvi.
English: For the full list of all side effects reported with Corlentor, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Corlentor potražite u uputi o lijeku.
English: Bradycardia (slow heart rate) is common (it may affect up to 1 in 10 people).
Croatian: 1 na 10 osoba) jest bradikardija (niska srčana frekvencija).
English: For the full list of restrictions with Corlentor, see the package leaflet.
Croatian: Potpuni popis ograničenja pri primjeni lijeka Corlentor potražite u uputi o lijeku.
English: Results showed that the medicine was more effective than placebo in one of the studies in 360 patients.
Croatian: Rezultati jednog ispitivanja na 360 bolesnika pokazali su da je Corlentor djelotvorniji od placeba.
English: EU (MA) Number
Croatian: Broj (EU) odobrenja (Zaštićeno) ime
English: Immediate packaging
Croatian: Put primjene Unutarnje pakiranje Veličina pakiranja
English: What is tylosin?
Croatian: Što je tilozin?
English: 10 July 2017
Croatian: 10. srpnja 2017.
English: The European Commission issued a decision on 10 July 2017.
Croatian: Europska komisija donijela je odluku 10. srpnja 2017.
English: Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/121)
Croatian: Ishod arbitražnog postupka u skladu s člankom 35. Direktive 2001/82/EZ (EMEA/V/A/121)
English: On 22 June 2016, Finland initiated a referral procedure under Article 35 of Directive 2001/82/EC for the aforementioned veterinary medicinal products.
Croatian: Finska je 22. lipnja 2016. pokrenula arbitražni postupak u skladu s člankom 35. Direktive 2001/82/EZ za navedene veterinarsko-medicinske proizvode.
English: Tylosin is a macrolide antibiotic and is active mostly against Gram-positive bacteria and mycoplasmas.
Croatian: Tilozin je makrolidni antibiotik i djelotvoran je uglavnom protiv gram-pozitivnih bakterija i mikoplazmi.
English: Tylosin and its phosphate and tartrate salts are used in veterinary medicines for treatment of conditions caused by sensitive organisms.
Croatian: Tilozin i njegovi fosfati te tartaratne soli koriste se u veterinarskim lijekovima za liječenje stanja prouzročenih osjetljivim organizmima.
English: Finland considered that ineffective treatment of mycoplasma mastitis with tylosin presents a serious concern to animal and public health as it delays the correct diagnosis, enables spread of the pathogen to other cows, impedes efficient/prudent control measures and increases risk for the development of antimicrobial resistance due to unnecessary use of antimicrobials.
Croatian: Finska je smatrala da neučinkovito liječenje mikoplazmatskog mastitisa tilozinom predstavlja razlog za ozbiljnu zabrinutost s obzirom na zdravlje životinja i javno zdravlje jer odgađa točnu dijagnozu, omogućava širenje patogena na druge krave, ometa djelotvorne/razborite mjere kontrole i povećava rizik za razvoj antimikrobne rezistencije zbog nepotrebne primjene antimikrobnih lijekova.
English: In the absence of submitted proprietary pre-clinical or clinical data for the products in the scope of this referral in support of the respective indication, the CVMP considered scientific references on efficacy.
Croatian: U nedostatku dostavljenih nekliničkih ili kliničkih vlasničkih podataka za proizvode obuhvaćene ovim arbitražnim postupkom kojima bi se poduprla predmetna indikacija, CVMP je razmotrio znanstvene reference o djelotvornosti.
English: Why were veterinary medicinal products containing tylosin that are administered parenterally and intended for the treatment of bovine mastitis caused by Mycoplasma spp.
Croatian: Pitanja i odgovori o veterinarsko-medicinskim proizvodima koji sadrže tilozin, primjenjuju se parenteralno i namijenjeni su za liječenje mastitisa goveda prouzročenog bakterijom Mycoplasma spp.
English: Based on the evaluation of the currently-available data, the CVMP concluded that, in the absence of specific pre-clinical or clinical data, and in light of the current scientific knowledge, the indication for treatment of bovine mastitis caused by Mycoplasma spp.
Croatian: Na temelju evaluacije trenutačno dostupnih podataka i u nedostatku nekliničkih ili kliničkih podataka te u svjetlu postojećih znanstvenih saznanja, CVMP je zaključio da nije dokazana indikacija za liječenje mastitisa goveda prouzročenog bakterijom Mycoplasma spp. veterinarsko-medicinskim proizvodima koji sadrže tilozin i koji se primjenjuju parenteralno.
English: On 16 March 2017, the European Medicines Agency (the Agency) completed a review of the effectiveness of veterinary medicinal products containing tylosin that are administered parenterally and intended for the treatment of bovine mastitis caused by Mycoplasma spp.
Croatian: Europska agencija za lijekove (Agencija) dovršila je 16. ožujka 2017. ocjenjivanje učinkovitosti veterinarsko-medicinskih proizvoda koji sadrže tilozin, primjenjuju se parenteralno i namijenjeni su za liječenje mastitisa goveda prouzročenog bakterijom Mycoplasma spp. U nedostatku nekliničkih ili kliničkih podataka, Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji zaključio je da liječenje mastitisa goveda prouzročenog bakterijom Mycoplasma spp. navedenim veterinarskomedicinskim proizvodima nije učinkovito.
English: The Committee recommended variations to the terms of the marketing authorisations for the aforementioned veterinary medicinal products in order to remove the indications ‘bovine mastitis caused by Mycoplasma spp.'
Croatian: Odbor je preporučio izmjene uvjeta odobrenja za stavljanje u promet za navedene veterinarsko-medicinske proizvode kako bi se iz informacija o veterinarsko-medicinskom proizvodu uklonile indikacije „mastitis goveda prouzročen bakterijom Mycoplasma spp.” ili „mastitis goveda prouzročen bakterijom Mycoplasma bovis”.
English: with veterinary medicinal products containing tylosin which are administered parenterally is not supported.
Croatian: Zašto su ocjenjivani veterinarsko-medicinski proizvodi koji sadrže tilozin,
English: The CVMP recommended deletion of the indications related to ‘bovine mastitis caused by Mycoplasma spp.'
Croatian: CVMP je preporučio da se iz informacija o veterinarskomedicinskom proizvodu za predmetne proizvode izbrišu indikacije koje se odnose na „mastitis goveda prouzročen bakterijom Mycoplasma spp.” ili „mastitis goveda prouzročen bakterijom Mycoplasma bovis”.
English: The CVMP was requested to review all available data and to provide its opinion on whether the indication related to 'bovine mastitis caused by Mycoplasma spp.'
Croatian: podatke i dostavi svoje mišljenje o tome je li indikacija koja se odnosi na „mastitis goveda prouzročen bakterijom Mycoplasma spp.” opravdana.
English: o uncontrolled hypertension,
Croatian: o nekontroliranom hipertenzijom,
English: A study is also needed to assess the effectiveness of the risk minimisation measures adopted during this review.
Croatian: Također je potrebno provesti ispitivanje kako bi se ocijenila učinkovitost mjera minimizacije rizika usvojenih tijekom ovog pregleda.
English: However, in individual cases autoimmune conditions may occur or be diagnosed later so healthcare professionals should be aware of this possibility.
Croatian: Međutim, u pojedinačnim slučajevima autoimune bolesti mogu se pojaviti ili dijagnosticirati kasnije, tako da zdravstveni radnici moraju biti svjesni te mogućnosti.
English: Having reviewed the PRAC recommendation, the CHMP agrees with the PRAC overall conclusions and grounds for recommendation.
Croatian: Nakon što je pregledao preporuku PRAC-a, CHMP je suglasan s općim zaključcima i razlozima za preporuku PRAC-a.
English: Furthermore, when selecting the most appropriate and effective treatment for the patient, the safety profile and the possibility to manage risks effectively should also be taken into consideration.
Croatian: Nadalje, pri odabiru najprikladnijeg i najučinkovitijeg liječenja za bolesnika također treba uzeti u obzir sigurnosni profil i mogućnost učinkovitog upravljanja rizicima.
English: o severe active infections until complete resolution,
Croatian: o teškim aktivnim infekcijama do postizanja potpunog oporavka,
English: Thus, due to the long term effect of alemtuzumab, treatment discontinuation has limited value from a risk management perspective.
Croatian: Stoga, zbog dugotrajnog učinka alemtuzumaba, prekid liječenja ima ograničenu vrijednost iz perspektive upravljanja rizikom.
English: In such circumstances it is necessary to restrict use of the alemtuzumab to patients who can benefit the most from treatment and who may be ready to accept the serious risks associated with treatment.
Croatian: U takvim okolnostima potrebno je ograničiti primjenu alemtuzumaba na bolesnike koji od liječenja mogu imati najviše koristi i koji su možda spremni prihvatiti ozbiljne rizike povezane s liječenjem.
English: PRAC also considered the views expressed by the neurology scientific advisory group.
Croatian: PRAC je također razmotrio stajališta znanstvene savjetodavne skupine za neurologiju.
English: PRAC noted that these risks, which are serious and which can in some cases have a fatal outcome, are largely unpredictable.
Croatian: PRAC je napomenuo da su ti rizici, koji su ozbiljni te u nekim slučajevima mogu imati smrtni ishod, uglavnom nepredvidivi.
English: Currently, safety follow-up of patients is recommended from initiation of the first treatment course and until 48 months after the last treatment course.
Croatian: Trenutačno se preporučuje sigurnosno praćenje bolesnika od započinjanja prvog ciklusa liječenja do 48 mjeseci nakon posljednjeg ciklusa liječenja.
English: During the assessment of the periodic safety update report (PSUSA) for Lemtrada (EMEA/H/C/PSUSA/00010055/201809), the following new emerging and serious safety concerns were highlighted in addition to the known safety profile of alemtuzumab, which raised major concerns to the Pharmacovigilance Risk Assessment Committee (PRAC):
Croatian: Tijekom procjene periodičkog izvješća o neškodljivosti (PSUSA) lijeka Lemtrada (EMEA/H/C/PSUSA/00010055/201809), pored poznatog sigurnosnog profila alemtuzumaba istaknuta su sljedeća nova i ozbiljna sigurnosna pitanja za koja Odbor za ocjenu rizika na području farmakovigilancije (PRAC) smatra da su vrlo zabrinjavajuća:
English: Provisional measures were introduced at the start of procedure to protect patients while the detailed evaluation was ongoing.
Croatian: Na početku postupka uvedene su privremene mjere kako bi se zaštitili bolesnici za vrijeme trajanja detaljne procjene.
English: Considering the serious and unpredictable nature of the newly-identified adverse reactions, it is important to understand whether the newly implemented measures are adhered to in clinical practice.
Croatian: S obzirom na ozbiljnu i nepredvidivu prirodu novootkrivenih nuspojava, važno je utvrditi slijede li se novoprovedene mjere u kliničkoj praksi.
English: This level of efficacy is present across a wide range of patient populations, as evidenced by the consistency of findings across various subgroups of participants in alemtuzumab clinical studies.
Croatian: Ta razina djelotvornosti prisutna je u širokom rasponu populacija bolesnika, što je dokazano dosljednošću nalaza u različitim podskupinama sudionika kliničkih ispitivanja alemtuzumaba.
English: - Fatal cases: Several fatal cases were identified during the PSUSA procedure, which indicate that the current recommendations for monitoring may be insufficient.
Croatian: - smrtni slučajevi: tijekom postupka PSUSA utvrđeno je nekoliko smrtnih slučajeva koji ukazuju na to da bi postojeće preporuke za praćenje mogle biti nedostatne.
English: The current evidence is insufficient to conclude on a causal relationship with Lemtrada.
Croatian: Postojeći dokazi nisu dostatni za donošenje zaključka o uzročnoj vezi s lijekom Lemtrada.
English: The PRAC considered a recommendation for a longer follow-up period in hospital (for up to 5 days after the last infusion) to allow for prompt identification and management of serious adverse reactions that may occur.
Croatian: PRAC je razmotrio preporuku za dulje razdoblje praćenja u bolnici (do pet dana nakon posljednje infuzije) kako bi se omogućilo brzo utvrđivanje i liječenje ozbiljnih nuspojava koje mogu nastupiti.
English: Therefore many of the newly-identified risks associated to Lemtrada are unpredictable and largely unavoidable.
Croatian: Zbog toga su mnogi novootkriveni rizici povezani s primjenom lijeka Lemtrada nepredvidivi i uglavnom neizbježni.