FrancophonIA/ELRC3.0 huggingface dataset:
English: Contact our press officer Monika Benstetter
Croatian: Kontaktirajte našeg djelatnika za medije Monika Benstetter
English: 15 January 2015 EMA/35715/2015
Croatian: 15. siječnja 2015. EMA/35715/2015
English: Healthcare professionals should follow these recommendations:
Croatian: Zdravstveni djelatnici trebaju se pridržavati sljedećih preporuka:
English: The EMA considered that the higher dose used in the study did not fully explain the findings.
Croatian: EMA je zaključila da veća doza korištena u ispitivanju ne objašnjava u potpunosti rezultate.
English: • If you have any questions or concerns, you should consult your doctor or another healthcare professional.
Croatian: • Ako imate bilo kakvih pitanja ili razloga za zabrinutost, savjetujte se s liječnikom ili drugim zdravstvenim djelatnikom.
English: Tel. +44 (0)20 3660 8427 E-mail: press@ema.europa.eu
Croatian: +44 (0)20 3660 8427 E-pošta: press@ema.europa.eu
English: Your doctor will regularly measure your heart rate particularly before starting treatment and when adjusting the dose.
Croatian: Vaš će liječnik redovito mjeriti Vašu frekvenciju srca posebice prije početka terapije te prilikom prilagođavanja doze.
English: Regular monitoring for the occurrence of atrial fibrillation is recommended.
Croatian: Preporučuje se redovito praćenje pojavljivanja atrijske fibrilacije.
English: The review was carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Croatian: Pregled je proveo Odbor za ocjenu rizika na području farmakovigilancije (PRAC), odbor odgovoran za evaluaciju sigurnosnih pitanja za humane lijekove, koje je izdalo niz preporuka.
English: In addition, discontinuation should be considered if the improvement is only limited and if there is no clinically relevant reduction in resting heart rate within 3 months.
Croatian: Nadalje, prekid terapije treba razmotriti ako je poboljšanje ograničeno, te ako ne postoji klinički značajno smanjenje u frekvenciji srca u mirovanju u roku od 3 mjeseca.
English: Its use is only beneficial for symptomatic treatment in patients with chronic stable angina pectoris who cannot be treated with beta-blockers, or in combination with beta-blockers in case their disease is not controlled with them alone.
Croatian: Njihova primjena korisna je samo u slučaju simptomatične terapije u bolesnika s kroničnom stabilnom anginom pektoris koji se ne mogu liječiti beta blokatorima, ili u kombinaciji s beta blokatorima u slučaju da se bolest ne može kontrolirati monoterapijom beta blokatorima.
English: It works by lowering the heart rate thereby reducing the stress on the heart and slowing the progression of heart failure and reducing or preventing the symptoms of angina.
Croatian: Lijek djeluje snižavajući frekvenciju srca, te tako smanjujući stres na srce i usporavajući progresiju zatajenja srca i smanjujući ili sprječavajući simptome angine.
English: The review of Procoralan/Corlentor was initiated on 8 May 2014 at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Croatian: Pregled lijekova Procoralan/Corlentor pokrenut je dana 8. svibnja 2014. na zahtjev Europske komisije sukladno članku 20.
English: Corlentor/Procoralan is available as tablets.
Croatian: Corlentor/Procoralan dostupni su kao tablete.
English: The PRAC recommendations were then sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's final opinion.
Croatian: Preporuke PRAC-a dostavljene su Odboru za lijekove za humanu uporabu (CHMP), odgovornom za pitanja u vezi s lijekovima za humanu uporabu, koji je usvojio konačno mišljenje Agencije.
English: • Healthcare professionals have been informed in writing of these new recommendations, and the product information for Corlentor/Procoralan has been updated accordingly.
Croatian: • Zdravstveni djelatnici informirani su pisanim putem o ovim novim preporukama, a informacije o proizvodu za lijekove Corlentor/Procoralan su primjereno ažurirane.
English: Corlentor and Procoralan are identical medicines that contain the active substance ivabradine.
Croatian: Corlentor i Procoralan su identični lijekovi koji sadrže djelatnu tvar ivabradin.
English: Doctors should consider stopping treatment if there is no improvement in angina symptoms after 3 months, or if the improvement is only limited.
Croatian: Liječnici trebaju razmisliti o prekidu terapije ako nema poboljšanja u simptomima angine nakon 3 mjeseca, ili ako je poboljšanje samo ograničeno.
English: If, despite dose reduction, the heart rate remains below 50 bpm or symptoms of bradycardia persist, treatment must be discontinued.
Croatian: Ako, usprkos smanjenju doze, frekvencija srca ostane manja od 50 bpm ili se simptomi bradikardije nastave, terapija se mora prekinuti.
English: Corlentor/Procoralan received an EU-wide marketing authorisation on 25 October 2005.
Croatian: Za lijekove Corlentor/Procoralan izdano je odobrenje za stavljanje lijeka u promet na razini EU dana 25. listopada 2005.
English: • If during treatment the heart rate decreases below 50 bpm at rest or the patient experiences symptoms related to bradycardia, the dose must be decreased (the lowest dose is 2.5 mg twice daily).
Croatian: • Ako se tijekom terapije frekvencija srca smanji na manje od 50 bpm u mirovanju ili bolesnik osjeti simptome povezane s bradikardijom, doza se mora smanjiti (najniža doza iznosi 2,5 mg dva puta na dan).
English: On 20 November 2014, the European Medicines Agency (EMA) completed a review of Corlentor/Procoralan (ivabradine) and made recommendations aimed at reducing the risk of heart problems, including heart attack and bradycardia (excessively low heart rate), in patients taking the medicine for angina.
Croatian: Dana 20. studenog 2014., Europska agencija za lijekove (EMA) završila je pregled lijekova Corlentor/Procoralan (ivabradin) te je iznijela preporuke usmjerene na smanjivanje rizika od srčanih problema, uključujući infarkt miokarda i bradikardiju (prekomjerno nisku frekvenciju srca), u bolesnika koji uzimaju lijek protiv angine.
English: However, the Agency reiterated that the starting dose for angina should not exceed 5 mg twice a day and that the maximum dose should not exceed 7.5 mg twice a day.
Croatian: No, Agencija je ponovila da početna doza za anginu ne smije premašivati 5 mg dva puta na dan te da maksimalna doza ne smije premašivati 7,5 mg dva puta na dan.
English: • Prior to starting treatment or when considering titration, serial heart rate measurements, ECG, or ambulatory 24-hour monitoring should be considered when determining the heart rate.
Croatian: • Prije početka liječenja ili prilikom razmatranja titracije, a pri utvrđivanju frekvencije srca potrebno je razmotriti niz mjerenja frekvencije srca, EKG ili ambulatorno 24-satno praćenje.
English: The CHMP opinion was sent to the European Commission, which issued an EU-wide legally binding decision on 15 January 2015.
Croatian: Mišljenje CHMP-a dostavljeno je Europskoj komisiji, koja je izdala pravno obvezujuću odluku na razini 15. siječnja 2015.
English: • Corlentor/Procoralan should be discontinued if the symptoms of angina do not improve within 3 months.
Croatian: • Terapiju lijekom Corlentor/Procoralan treba prekinuti ako se simptomi angine ne poboljšaju u roku od 3 mjeseca.
English: The CHMP opinion was sent to the European Commission, which issued a legally binding decision valid throughout the EU on 15 January 2015.
Croatian: Mišljenje CHMP-a dostavljeno je Europskoj komisiji, koja je izdala pravno obvezujuću odluku valjanu na razini EU dana 15. siječnja 2015. godine.
English: The PRAC recommendations have been endorsed by the Agency's Committee for Medicinal Products for Human Use (CHMP).
Croatian: Preporuke PRAC-a potvrđene su od strane Odbora za lijekove za humanu uporabu (CHMP) pri Agenciji.
English: These recommendations are based on the EMA's review of the final data from the SIGNIFY study1, which showed that in a subgroup of patients who had symptomatic angina there was a small but significant increase in the combined risk of cardiovascular death or non-fatal heart attack with Corlentor/Procoralan compared with placebo (3.4% vs 2.9% yearly incidence rates).
Croatian: Ove se preporuke temelje na pregledu EMA-e za konačne podatke za ispitivanje SIGNIFY 1, kojim je potvrđeno da je u podgrupi bolesnika koji imaju simptomatičnu anginu bilo prisutno malo, no značajno povećanje u kombiniranom riziku od kardiovaskularne smrti ili nesmrtonosnog infarkta miokarda s lijekovima Corlentor/Procoralan u usporedbi s placebom (3,4% u odnosu na 2,9% godišnjih stopa incidencije).
English: Other recommendations are that doctors must not prescribe Corlentor/Procoralan together with the medicines verapamil or diltiazem that reduce the heart rate, and that they should monitor their patients for atrial fibrillation (irregular rapid contractions of the upper chambers of the heart).
Croatian: Druge preporuke su da liječnici ne smiju propisivati Corlentor/Procoralan zajedno s lijekovima verapamil ili diltiazem koji smanjuju frekvenciju srca, te da trebaju nadzirati bolesnike kako bi uočili fibrilaciju atrija (nepravilne brze kontrakcije gornjih srčanih komora).
English: • The risk of developing atrial fibrillation is increased in patients treated with Corlentor/Procoralan.
Croatian: • Rizik od razvoja atrijske fibrilacije povećava se u bolesnika liječenih lijekovima Corlentor/Procoralan.
English: In its evaluation the EMA also assessed additional data on the safety and effectiveness of Corlentor/Procoralan which showed that the risk of atrial fibrillation is increased in patients treated with Corlentor/Procoralan compared with controls (4.9% vs 4.1%).
Croatian: U svojoj ocijeni EMA je također ocijenila dodatne podatke o sigurnosti i djelotvornosti lijekova Corlentor/Procoralan koji potvrđuju kako je rizik od atrijske fibrilacije povišen u bolesnika liječenih lijekom Corlentor/Procoralan u usporedbi s kontrolama (4,9% u odnosu na 4,1%).
English: Because of a small but significant increase of the combined risk of cardiovascular death, myocardial infarction and heart failure seen in patients with symptomatic angina in the SIGNIFY study, recommendations have been issued to reduce this risk.
Croatian: Uslijed malog, no značajnog povećanja u kombiniranom riziku od kardiovaskularne smrti, infarkta miokarda i zatajenja srca uočenih u bolesnika sa simptomatičnom anginom u ispitivanju SIGNIFY , izdane su preporuke sa ciljem snižavanja ovog rizika.
English: Patients in the SIGNIFY study were started on a higher than recommended dose of Corlentor/Procoralan and received up to 10 mg twice a day, which is higher than the currently authorised maximum daily dose (7.5 mg twice a day).
Croatian: Bolesnici obuhvaćeni ispitivanjem SIGNIFY počeli su uzimati dozu veću od preporučene lijeka Corlentor/Procoralan i primili su do 10 mg dva puta na dan, što je više od trenutno odobrene maksimalne dnevne doze (7,5 mg dva puta na dan).
English: • Corlentor/Procoralan must not be used together with the medicines verapamil or diltiazem which reduce the heart rate.
Croatian: • Corlentor/Procoralan ne smiju se koristiti zajedno s lijekovima verapamilom ili diltiazemom, koji smanjuju frekvenciju srca.
English: The data also indicated a higher risk of bradycardia with Corlentor/Procoralan compared with placebo (17.9% vs.
Croatian: Podaci također ukazuju na povišen rizik od bradikardije s lijekovima Corlentor/Procoralan u usporedbi s placebom (17,9% u odnosu na 2,1%).
English: • The benefit-risk balance of Corlentor/Procoralan remains positive for its authorised indications.
Croatian: • Omjer koristi i rizika za lijekove Corlentor/Procoralan ostaje pozitivan za odobrene indikacije.
English: • The concomitant use of Corlentor/Procoralan with verapamil or diltiazem is now contraindicated.
Croatian: • Istovremena primjena lijeka Corlentor/Procoralan s verapamilom ili diltiazemom sada je kontraindicirana.
English: Corlentor/Procoralan is also used in patients with long-term heart failure (when the heart cannot pump enough blood to the rest of the body).
Croatian: Lijek Corlentor/Procoralan također se koristi u bolesnika s dugoročnim zatajenjem srca (u slučaju kada srce ne može pumpa dovoljno krvi u ostatak tijela).
English: Because patients treated with Corlentor/Procoralan for angina symptoms may be at increased risk of heart problems such as heart attack, recommendations have been issued to reduce this risk and ensure that the benefits continue to outweigh the risks.
Croatian: Budući da bolesnici liječeni lijekovima Corlentor/Procoralan za simptome angine mogu biti izloženi povećanom riziku od srčanih problema poput infarkta miokarda, izdane su preporuke za smanjivanje ovog rizika te kako bi se osiguralo da koristi i dalje nadmašuju rizike.
English: • Your doctor will stop treatment with Corlentor/Procoralan if your symptoms of angina (such as shortness of breath) do not improve within 3 months or if the improvement is only limited.
Croatian: • Vaš će liječnik prekinuti terapiju lijekovima Corlentor/Procoralan ako se Vaši simptomi angine (poput zadihanosti) ne poboljšaju unutar 3 mjeseca ili ako je poboljšanje samo ograničeno.
English: • The data from SIGNIFY did not demonstrate a beneficial effect for Corlentor/Procoralan on cardiovascular outcomes in coronary artery patients without clinical heart failure.
Croatian: • Podaci prikupljeni ispitivanjem SIGNIFY nisu potvrdili korisno djelovanje lijekova Corlentor/Procoralan na kardiovaskularne ishode u koronarnim arterijama bolesnika bez kliničkog zatajenja srca.
English: • The starting dose of Corlentor/Procoralan should not exceed 5 mg twice daily and the maintenance dose of Corlentor/Procoralan should not exceed 7.5 mg twice daily.
Croatian: • Početna doza lijeka Corlentor/Procoralan ne smije premašivati 5 mg dva puta dnevno, a doza održavanja lijeka Corlentor/Procoralan ne smije premašivati 7,5 mg dva puta dnevno.
English: Because Corlentor/Procoralan has not been shown to provide benefits such as reducing the risk of heart attack or cardiovascular death (death due to heart problems), the medicine should only be used to alleviate symptoms of angina.
Croatian: Budući da za lijek Corlentor/Procoralan nije utvrđeno da pruža koristi poput smanjivanja rizika od infarkta miokarda ili kardiovaskularne smrti (smrti uslijed problema sa srcem), lijek treba koristiti samo za uklanjanje simptoma angine.
English: If atrial fibrillation develops during treatment, the balance of benefits and risks of continued Corlentor/Procoralan treatment should be carefully reconsidered.
Croatian: Ako se atrijska fibrilacija razvije tijekom terapije, treba pažljivo razmotriti omjer koristi i rizika nastavka terapije lijekovima Corlentor/Procoralan.
English: • Your doctor will start treatment with Corlentor/Procoralan at a dose of up to 5 mg twice daily and increase it if necessary to a maximum of 7.5 mg twice daily.
Croatian: • Vaš će liječnik započeti terapiju lijekovima Corlentor/Procoralan u dozi do 5 mg dva puta dnevno te povećati je prema potrebi na maksimalno 7,5 mg dva puta dnevno.
English: • In the symptomatic treatment of patients with chronic stable angina, Corlentor/Procoralan should only be started if the patient's resting heart rate is above or equal to 70 beats per minute (bpm).
Croatian: • U simptomatičnom liječenju bolesnika s kronično stabilnom anginom, terapiju lijekom Corlentor/Procoralan treba započeti samo ako je frekvencija srca bolesnika u mirovanju veća ili jednaka 70 otkucaja po minuti (bpm).
English: Corlentor/Procoralan is used to treat symptoms of long-term stable angina (chest pain due to problems with the blood flow to the heart) in adults with coronary heart disease (disease of the heart caused by the obstruction of the blood vessels that supply blood to the heart muscle) who have a normal heart rhythm.
Croatian: Corlentor/Procoralan koriste se za liječenje simptoma dugotrajne stabilne angine (boli u prema s dotokom krvi u srce) u odraslih osoba s koronornom srčanom bolesti (bolesti srca uzrokovanom destrukcijom krvnih žila koje isporučuju krv u srčani mišić) koji imaju normalni srčani ritam.
English: When used for angina, Corlentor/Procoralan should only be started if the patient's resting heart rate is at least 70 beats per minute (bpm).
Croatian: Ako se koristi za anginu, terapiju lijekovima Corlentor/Procoralan treba započeti samo ako frekvencija srca bolesnika u mirovanju iznosi najmanje 70 otkucaja po minuti (bpm).
English: The review of Corlentor/Procoralan was first carried out by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC).
Croatian: Odbor za ocjenu rizika na području farmakovidgilancije (PRAC) pri EMA-i prvo je izvršilo pregled lijekova Corlentor/Procoralan.
English: 1 Fox K. Ford I, Steg PG, et al. Ivabradine in stable coronary artery disease without clinical heart failure.
Croatian: Ivabradine in stable coronary artery disease without clinical heart failure.
English: • Corlentor/Procoralan is a medicine used to treat symptoms of angina (chest pain due to problems with the blood flow to the heart) and to treat heart failure.
Croatian: • Corlentor/Procoralan je lijek koji se koristi za liječenje simptoma angine (boli u prsima uslijed problema s dotokom krvi u srce) i za liječenje zatajenja srca.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom was observed in 5.3% of patients taking Corlentor/Procoralan compared with 3.8% in the placebo group.
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: • Your doctor will only start Corlentor/Procoralan if your resting heart rate is at least 70 beats per minute (bpm).
Croatian: • Vaš liječnik može započeti terapiju lijekom Corlentor/Procoralan ako frekvencija srca u mirovanju iznosi najmanje 70 otkucaja po minuti (bpm).
English: Corlentor/Procoralan is used to treat symptoms of angina (chest pain due to problems with the blood flow to the heart) and to treat heart failure.
Croatian: Corlentor/Procoralan koristi se za liječenje simptoma angine (boli u prsima uslijed problema s dotokom krvi u srce) i za liječenje zatajenja srca.
English: • As Corlentor/Procoralan could cause irregular rapid contractions of the upper chambers of the heart (a condition known as atrial fibrillation) your doctor will monitor your heart function regularly and will reconsider treatment if atrial fibrillation develops.
Croatian: • Budući da lijekovi Corlentor/Procoralan mogu uzrokovati brze kontrakcije gornjih komora srca (stanje poznato pod nazivom atrijska fibrilacija)
English: This is normal.)
Croatian: To je normalno.)
English: Do not be concerned, as you will remove the air in a later step.
Croatian: Ne brinite, jer ćete istisnuti taj zrak u sljedećem koraku.
English: Some of these patients have been under 50 years of age.
Croatian: Neki od ovih bolesnika bili su mlađi od 50 godina.
English: The absolute bioavailability is 76%.
Croatian: Apsolutna bioraspoloživost iznosi 76%.
English: This is due to air pressure and should not be of concern.
Croatian: To je zbog tlaka zraka i ne treba se oko toga zabrinjavati.
English: Wash your hands with soap and warm water.
Croatian: Operite ruke sapunom i toplom vodom.
English: • Wash your hands thoroughly.
Croatian: • Temeljito operite ruke.
English: The half-life is long, approximately 70 hours.
Croatian: Poluvijek je dug, približno 70 sati.
English: Serious allergic reactions are rare.
Croatian: Ozbiljne alergijske reakcije su rijetke.
English: LIFMIOR can be taken with or without food or drink.
Croatian: LIFMIOR se može primjenjivati sa ili bez hrane ili pića.
English: Key results of studies 2, 3 and 4 are shown below.
Croatian: Ključni rezultati ispitivanja 2, 3 i 4 prikazani su dolje.
English: The 2 year data did not reveal any new safety findings.
Croatian: Dvogodišnji podaci nisu otkrili nove sigurnosne nalaze.
English: Do not warm LIFMIOR in any other way (for example, do not warm it in a microwave or in hot water).
Croatian: Nemojte zagrijavati LIFMIOR ni na koji drugi način (na primjer, nemojte ga zagrijavati u mikrovalnoj pećnici ili toploj vodi).
English: Please read the instructions carefully and follow them step by step.
Croatian: Molimo da upute pažljivo pročitate te da ih slijedite korak po korak.
English: Follow the directions given by the doctor.
Croatian: Slijedite upute koje je dao liječnik.
English: CORRECT INCORRECT
Croatian: ISPRAVNO NEISPRAVNO
English: • The risk of opportunistic infections and tuberculosis (TB)
Croatian: • rizik od oportunističkih infekcija i tuberkuloze (TBC)
English: SE = standard error.
Croatian: 12. mjesec SE = standardna pogreška.
English: Wait until all the powder dissolves (usually less than 10 minutes).
Croatian: Pričekajte da se prašak otopi (obično manje od 10 minuta).
English: Read all (both sides) of this leaflet carefully before you start using this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu (obje strane) prije nego počnete primjenjivati ovaj lijek jer sadrži Vama važne podatke.
English: (It may be helpful to keep notes on the location of the previous injections.)
Croatian: (Vođenje zabilješki o mjestima davanja prethodnih injekcija može biti korisno).
English: Always have the outer carton of the medicine with you, even if it is empty.
Croatian: Uvijek sa sobom ponesite kutiju lijeka, čak i ako je prazna.
English: With continued therapy, responses were maintained up to 48 weeks.
Croatian: Uz nastavak terapije odgovori su bili održani do 48 tjedana.
English: This appearance is normal for LIFMIOR.
Croatian: Ovakav izgled je normalan za LIFMIOR.
English: (Note: After you have completed these steps, a small amount of liquid may remain in the vial.
Croatian: (Napomena: Nakon što se završili s ovim koracima, u bočici može preostati mala količina otopine.
English: Uveitis, scleritis
Croatian: Uveitis, skleritis
English: The healthcare professional's educational material should contain the following key elements:
Croatian: Edukacijski materijal za zdravstvene radnike treba sadržavati sljedeće ključne elemente:
English: If you use more LIFMIOR than you should
Croatian: Ako primijenite više LIFMIORa nego što ste trebali
English: Green activation button
Croatian: Zeleni gumb za aktivaciju
English: Mean duration was approximately 3 to 5 days.
Croatian: Srednja vrijednost trajanja bila je od 3 do 5 dana.
English: Double-Blind Clinical Responses at Week 12
Croatian: Dvostruko slijepi klinički odgovori u 12. tjednu
English: Frequency Not Known (Cannot be Estimated from Available Data)
Croatian: Nepoznata učestalost (ne može se procijeniti iz dostupnih podataka)
English: This Fc component contains the hinge, CH2 and CH3 regions, but not the CH1 region of IgG1.
Croatian: Ta Fc komponenta sadrži spojno mjesto, regije CH2 i CH3, ali ne i regiju CH1 IgG1.
English: Always use this medicine exactly as the doctor has told you.
Croatian: Uvijek primijenite ovaj lijek točno onako kako Vam je rekao liječnik.
English: Use only the items listed.
Croatian: Upotrebljavajte samo one predmete koji su nabrojani.
English: Long-term studies to assess the safety of the combination are ongoing.
Croatian: Dugoročna ispitivanja za procjenu sigurnosti primjene ove kombinacije su u tijeku.
English: D-88397 Biberach an der Riss
Croatian: D-88397 Biberach an der Riss Njemačka
English: Consequently, the choice of intermittent or continuous therapy should be based upon physician judgment and individual patient needs.
Croatian: Stoga, izbor intermitentnog ili kontinuiranog liječenja treba biti temeljen na procjeni liječnika i pojedinačnih potreba bolesnika.
English: • The pen should be used once only - it should never be re-used.
Croatian: • Brizgalica se smije uporabiti samo jednom - nikad se ne smije ponovno uporabiti.
English: These are rare or uncommon side effects, but are serious conditions (some of which may rarely be fatal).
Croatian: Ovo su rijetke ili manje česte nuspojave, ali su ozbiljna stanja (neka od njih ponekad mogu biti smrtonosna).
English: Dosing for adult patients (aged 18 years or over)
Croatian: Primjena u odraslih bolesnika (u dobi od 18 ili više godina)