FrancophonIA/ELRC3.0 huggingface dataset:
English: The bacteria in Raligize have had a gene inserted in their DNA so they can produce a new substance containing one of the HPV proteins, E7, linked to part of another protein, listeriolysin O. The linked protein is able to stimulate the immune system against E7.
Croatian: U DNK bakterija u lijeku Raligize unesen je gen kako bi proizvodile novu tvar koja sadržava jedan od proteina HPV-a, E7, koji je povezan s dijelom drugog proteina, listeriolizina O.
English: * Tissue culture infectious dose 50%
Croatian: ∗ 50 % infektivne doze kulture tkiva
English: --1 Lyophilisate (live attenuated) Canine distemper virus, strain Bio CDV 11/A
Croatian: --1 Liofilizat (živi, atenuirani) Virus štenećaka, soj CDV Bio 11/
English: Canine parvovirus Type 2b, strain CPV-2b Bio 12/B
Croatian: Pseći parvovirus tip 2b, soj CPV-2b-Bio 12/B 104.3 -106.6 TCID50* Pseći parainfluenca virus tip 2, soj CpiV-Bio 15 103.1 -105.1 TCID50*
English: Lyophlilisate: 1 dose + solvent: 1 ml
Croatian: Liofilizat: staklena bočica Otapalo: staklena bočica
English: moroctocog alfa
Croatian: moroktokog alfa
English: The full EPAR for ReFacto AF can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek ReFacto AF nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: In February 2009, a number of changes to the way ReFacto is made were introduced.
Croatian: U veljači 2009. uvedene su brojne promjene u postupak proizvodnje lijeka ReFacto.
English: The European Commission granted a marketing authorisation valid throughout the European Union for ReFacto AF on 13 April 1999.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek ReFacto AF na snazi u Europskoj uniji od 13. travnja 1999.
English: What measures are being taken to ensure the safe and effective use of ReFacto AF?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka ReFacto AF?
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for ReFacto AF.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i svoje preporuke za uporabu lijeka ReFacto AF.
English: Uncommonly, patients may also develop allergic reactions.
Croatian: Bolesnici rijetko doživljavaju alergijske reakcije.
English: Following these changes, the company carried out a study to show that ReFacto and ReFacto AF were treated by the body in the same way.
Croatian: Nakon tih promjena tvrtka je provela ispitivanje kako bi pokazala da tijelo reagira na lijekove ReFacto i ReFacto AF na isti način.
English: Patients may also develop antibodies against factor VIII medicines such as Refacto AF.
Croatian: Bolesnici također mogu razviti protutijela protiv lijekova za faktor VIII kao što je ReFacto AF.
English: ReFacto AF can be used in patients of all ages, including newborns.
Croatian: Lijek ReFacto AF može se primjenjivati u bolesnika svih dobi, uključujući novorođenčad.
English: These are known as inhibitors as they can prevent the medicine from working effectively, which may result in a loss of bleeding control.
Croatian: Ta su protutijela poznata kao inhibitori koji mogu spriječiti djelovanje lijeka što može dovesti do gubitka kontrole nad krvarenjem.
English: This is a summary of the European public assessment report (EPAR) for ReFacto AF.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek ReFacto AF.
English: These included removal of the use of a protein called albumin, which is produced from human blood, from the manufacturing process.
Croatian: Te su promjene obuhvaćale uklanjanje uporabe bjelančevine albumin, koja se dobiva iz ljudske krvi, iz postupka proizvodnje.
English: Patients with haemophilia A lack factor VIII, a protein needed for normal clotting of the blood, and as a result, they bleed readily and may have problems, such as bleeding in the joints, muscles and internal organs.
Croatian: Bolesnici s hemofilijom A nemaju dostatne razine faktora VIII, proteina potrebnog za normalno zgrušavanje krvi, pa stoga lako krvare i mogu imati probleme poput krvarenja u zglobovima, mišićima i unutarnjim organima.
English: The active substance in ReFacto AF, moroctocog alfa, works in the body in the same way as human factor VIII.
Croatian: Djelatna tvar u lijeku ReFacto AF, moroktokog alfa, djeluje u tijelu na isti način kao ljudski faktor VIII.
English: Other information about ReFacto AF
Croatian: Ostale informacije o lijeku ReFacto AF
English: ReFacto AF is given by injection into a vein over several minutes.
Croatian: Lijek ReFacto AF daje se injekcijom u venu u trajanju od nekoliko minuta.
English: For more information about treatment with ReFacto AF, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom ReFacto AF pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: The CHMP noted that ReFacto AF was comparable to ReFacto, the original form of the medicine.
Croatian: CHMP je ocijenio da je lijek ReFacto AF usporediv s lijekom ReFacto, izvornim oblikom lijeka.
English: Full details on how to calculate the dose are included in the summary of product characteristics (also part of the EPAR).
Croatian: Potpune informacije o načinu izračunavanja doza sadržane su u sažetku opisa svojstava lijeka (također dio EPAR-a).
English: The dose and the frequency of treatment depend on whether ReFacto AF is used to treat or prevent bleeding, the seriousness of the condition, the extent and location of the bleeding or the type of surgery, and the patient's bodyweight.
Croatian: Doza i učestalost terapije ovise o tome koristi li se lijek ReFacto AF za liječenje ili sprečavanje krvarenja, ozbiljnosti stanja, snazi i mjestu krvarenja ili vrsti operacije te bolesnikovoj tjelesnoj težini.
English: The name of the medicine was also changed from ReFacto to ReFacto AF.
Croatian: Naziv lijeka promijenjen je iz ReFacto u ReFacto AF.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Refacto AF 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 ReFacto AF nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Patients or their carers can give injections of ReFacto AF, provided that they have been trained appropriately.
Croatian: Bolesnici ili njihovi njegovatelji mogu davati injekcije lijeka ReFacto AF ako su odgovarajuće osposobljeni za to.
English: ReFacto AF contains the active substance moroctocog alfa.
Croatian: ReFacto AF sadrži djelatnu tvar moroktokog alfa.
English: The most common side effects with ReFacto AF (seen in more than 1 patient in 10) are headache, cough, pain in the joints and fever.
Croatian: Najčešće su nuspojave lijeka ReFacto AF (koje se mogu javiti u više od 1 na 10 bolesnika) glavobolja, kašalj, bol u zglobovima i vrućica.
English: ReFacto AF must not be used in people who are hypersensitive (allergic) to human coagulation factor VIII, to any of the other ingredients or to hamster proteins.
Croatian: Lijek ReFacto AF ne smije se koristiti u osoba koje su preosjetljive (alergične) na rekombinantni koagulacijski faktor VIII, na bilo koji drugi sastojak ovog lijeka ili na proteine hrčka.
English: ReFacto AF was first authorised as ReFacto in April 1999, for use in previously treated and untreated patients with haemophilia A, based on the results of three main studies.
Croatian: Lijek ReFacto AF odobren je u travnju 1999. pod nazivom ReFacto za primjenu u prethodno liječenih i neliječenih bolesnika s hemofilijom A na temelju rezultata triju glavnih ispitivanja.
English: ReFacto AF should be started under the supervision of a doctor who has experience in the treatment of haemophilia A.
Croatian: Liječenje lijekom ReFacto AF treba započeti pod nadzorom liječnika s iskustvom u liječenju hemofilije A.
English: It is available as vials or pre-filled syringes.
Croatian: Dostupan je u bočicama ili napunjenim štrcaljkama.
English: The studies showed that ReFacto AF was as safe and effective as ReFacto in preventing and treating bleeding episodes in patients with haemophilia A.
Croatian: Ispitivanja su pokazala da je lijek ReFacto AF jednako neškodljiv i djelotvoran kao i lijek ReFacto za sprječavanje i liječenje epizoda krvarenja u bolesnika s hemofilijom A.
English: It also carried out two main studies looking at the effectiveness of ReFacto AF: the first looked at the prevention and treatment of bleeding episodes in 94 previously treated patients and the second looked at the prevention of bleeding in 22 patients having surgery.
Croatian: Prvo se ispitivanje odnosilo na sprečavanje i liječenje epizoda krvarenja u 94 prethodno neliječenih bolesnika, dok se drugo odnosilo na sprečavanje krvarenja u 22 kirurška pacijenta.
English: ReFacto AF is used for the treatment and prevention of bleeding in patients with haemophilia A (an inherited bleeding disorder).
Croatian: Lijek ReFacto AF koristi se za liječenje i prevenciju krvarenja bolesnika s hemofilijom A (nasljednim poremećajem krvarenja).
English: What is the risk associated with ReFacto AF?
Croatian: Koji su rizici povezani s lijekom ReFacto AF?
English: Why has ReFacto AF been approved?
Croatian: Zašto je lijek ReFacto AF odobren?
English: The human coagulation factor VIII in ReFacto AF is not extracted from human blood but is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce human coagulation factor VIII.
Croatian: Ljudski koagulacijski faktor VIII u lijeku ReFacto AF ne ekstrahira se iz ljudske krvi nego se proizvodi metodom poznatom kao „tehnologija rekombinantne DNK”.
English: Therefore, the Committee decided that the benefits of ReFacto AF are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka ReFacto AF nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: ReFacto AF is a powder and solvent used to make up a solution for injection.
Croatian: Lijek ReFacto AF dostupan je u obliku praška i otapala koji se zajedno miješaju kako bi se dobila otopina za injekciju.
English: How is ReFacto AF used?
Croatian: Kako se ReFacto AF koristi?
English: What is ReFacto AF used for?
Croatian: Za što se ReFacto AF koristi?
English: What benefit has ReFacto AF shown during the studies?
Croatian: Koje su koristi lijeka ReFacto AF utvrđene u ispitivanjima?
English: What is ReFacto AF?
Croatian: Što je ReFacto AF?
English: For the full list of all side effects reported with ReFacto AF, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka ReFacto AF potražite u uputi o lijeku.
English: How does ReFacto AF work?
Croatian: Kako je ReFacto AF ispitivan?
English: (Invented) name Strength Pharmaceutical Form
Croatian: Broj (EU) odobrenja (Zaštićeno) ime Doza Farmaceutski oblik
English: Route of Administration
Croatian: Način uzimanja Unutarnje pakiranje
English: Each study lasted three to four months.
Croatian: Svako je ispitivanje trajalo od tri do četiri mjeseca.
English: This overview was last updated in 11-2018.
Croatian: Pregled informacija posljednji je put ažuriran u 11. 2018.
English: This authorisation was based on the authorisation granted to Procoralan in 2005 (‘informed consent').
Croatian: Odobrenje se temeljilo na odobrenju izdanom za lijek Procoralan 2005. godine („informirani pristanak”).
English: In stable angina, these symptoms appear during physical effort.
Croatian: Pri stabilnoj angini ti se simptomi javljaju za vrijeme fizičkog napora.
English: The main measure of effectiveness was a reduction in the risk of death due to heart problems and non-fatal heart attack.
Croatian: Glavna mjera djelotvornosti bilo je smanjenje rizika od smrti uslijed srčanih problema i nesmrtonosnog srčanog udara.
English: However it should be noted that patients in this study were given doses higher than the recommended dose (up to 10 mg twice a day).
Croatian: Međutim, valja napomenuti kako su bolesnici u ovom ispitivanju primali doze više od preporučene doze (do 10 mg dva puta dnevno).
English: Results showed that the medicine was more effective than placebo in one of the studies in 360 patients.
Croatian: Rezultati su pokazali da je lijek bio djelotvorniji od placeba u jednom od ispitivanja u 360 bolesnika.
English: Further information on Ivabradine Anpharm can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Ivabradine-Anpharm.
Croatian: Više informacija o lijeku Ivabradine Anpharm nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/Ivabradine-Anpharm.
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.
Croatian: Glavna mjera djelotvornosti bilo je vrijeme u kojem su bolesnici mogli vježbati na biciklu ili traci za trčanje, mjereno na početku i kraju svakog ispitivanja.
English: Bradycardia (slow heart rate) is common (it may affect up to 1 in 10 people).
Croatian: Bradikardija (usporena srčana frekvencija) je česta (može se pojaviti u do 1 na 10 osoba).
English: It must not be used in women who are pregnant, breastfeeding or by women who could become pregnant and who are not using appropriate contraceptives.
Croatian: Ne smije se upotrebljavati u trudnica, dojilja ili žena koje mogu zatrudnjeti i koje ne primjenjuju prikladnu metodu kontrole začeća.
English: In patients over 75 years old, a lower starting dose of 2.5 mg twice a day can be used.
Croatian: U bolesnika starijih od 75 godina može se primijeniti manja početna doza od 2,5 mg dva puta dnevno.
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.
Croatian: Preporučena početna doza iznosi 5 mg dnevno uz jelo, koju liječnik može povećati na 7,5 mg dva puta dnevno ili smanjiti na 2,5 mg (pola tablete od 5 mg) dva puta dnevno ovisno o bolesnikovoj srčanoj frekvenciji i simptomima.
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: Kada su te struje blokirane, srčana se frekvencija smanjuje tako da srce mora manje raditi te treba manje oksigenirane krvi.
English: However, a fifth study in 728 patients showed that adding Ivabradine Anpharm to amlodipine did not provide an additional benefit.
Croatian: Međutim, peto je ispitivanje u 728 bolesnika pokazalo da dodavanje lijeka Ivabradine Anpharm amlodipinu nije imalo dodatne koristi.
English: When used for angina, treatment should be stopped if symptoms do not improve after 3 months.
Croatian: Pri liječenju angine liječenje treba prekinuti ako se simptomi ne ublaže nakon tri mjeseca.
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 bi trebao razmotriti prekid liječenja ako lijek samo ograničeno djeluje na ublažavanje simptoma angine ili smanjenje srčane frekvencije u roku od tri mjeseca.
English: In a fourth study in 889 patients, Ivabradine Anpharm was more effective than placebo when both were added to atenolol.
Croatian: U četvrtom ispitivanju na 889 bolesnika, lijek Ivabradine Anpharm bio je djelotvorniji od placeba kad su oba dodana atenololu.
English: Ivabradine Anpharm therefore reduces or prevents the symptoms of angina.
Croatian: Stoga Ivabradine Anpharm smanjuje ili sprječava simptome angine.
English: Ivabradine Anpharm is available as tablets (5 and 7.5 mg) and can only be obtained with a prescription.
Croatian: Ivabradine Anpharm dostupan je u obliku tableta (5 i 7,5 mg) te se izdaje samo na liječnički recept.
English: Results showed that it 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 Ivabradine Anpharm 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 bio djelotvorniji od placeba prilikom sprječavanja smrti zbog bolesti srca ili krvnih žila, odnosno hospitalizacije zbog pogoršanog zatajenja srca: 24,5 % (793 od 3241) bolesnika liječenih lijekom Ivabradine Anpharm preminulo ili je hospitalizirano zbog pogoršanja zatajenja srca u usporedbi s 28,7 % (937 od 3264) bolesnika liječenih placebom.
English: Ivabradine Anpharm must not be taken with a number of other medicines.
Croatian: Ivabradine Anpharm se ne smije uzimati s nizom drugih lijekova.
English: Ivabradine Anpharm received a marketing authorisation valid throughout the EU on 8 September 2015.
Croatian: Lijek Ivabradine Anpharm dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 8. rujna 2015.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ivabradine Anpharm 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 Ivabradine Anpharm nalaze se u sažetku opisa svojstava i u uputi o lijeku.
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 djelotvoran kao atenolol (beta-blokator) u ispitivanju 939 bolesnika i kao amlodipin (drugi lijek za liječenje angine) u ispitivanju 1195 bolesnika.
English: Ivabradine Anpharm (ivabradine)
Croatian: Ivabradine Anpharm (ivabradin)
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 Ivabradine Anpharm compared with placebo (3.4% vs 2.9% yearly incidence rates).
Croatian: U tom je ispitivanju specifična podskupina bolesnika sa simptomatskom anginom imala maleno, no značajno, povećanje kombiniranog rizika od kardiovaskularne smrtnosti ili nesmrtonosnog srčanog udara s lijekom Ivabradine Anpharm u usporedbi s placebom (godišnje stope incidencije 3,4 % u usporedbi s 2,9 %).
English: Ivabradine Anpharm 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: Ivabradine Anpharm se ne smije upotrebljavati u bolesnika u kojih je srčana frekvencija u mirovanju manja od 70 otkucaja u minuti, koji imaju vrlo nizak krvni tlak, razne vrste srčanih poremećaja (uključujući kardiogeni šok, poremećaje ritma, srčani udar, nestabilno ili akutno (iznenadno) zatajenje srca i nestabilnu anginu) ili ozbiljne probleme s jetrom.
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 treba prekinuti ako je srčana frekvencija kontinuirano niža od 50 otkucaja u minuti ili ako se nastave simptomi bradikardije (spore srčane frekvencije).
English: It also concluded that Ivabradine Anpharm was effective in long-term heart failure with an acceptable safety profile.
Croatian: Agencija je također zaključila da je lijek Ivabradine Anpharm bio djelotvoran u dugoročnom zatajenju srca s prihvatljivim sigurnosnim profilom.
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 upotrebljava u bolesnika s normalnim srčanim ritmom i srčanom frekvencijom od najmanje 70 otkucaja u minuti.
English: What measures are being taken to ensure the safe and effective use of Ivabradine Anpharm?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ivabradine Anpharm?
English: The most common side effect with Ivabradine Anpharm (which may affect more than 1 in 10 people) is luminous phenomena or ‘phosphenes' (a temporary brightness in the field of vision).
Croatian: Najčešća nuspojava lijeka Ivabradine Anpharm (može se pojaviti u 1 na 10 ljudi) je vidni poremećaj u obliku „fosfena” (privremena sljepoća u vidnom polju).
English: It is used in combination with standard therapy including beta blockers, or in patients who cannot be treated with beta blockers.
Croatian: Upotrebljava se u kombinaciji sa standardnom terapijom koja uključuje beta-blokatore ili u bolesnika koje se ne može liječiti beta-blokatorima.
English: By lowering the heart rate, Ivabradine Anpharm reduces the stress on the heart, thereby slowing the progression of heart failure and improving symptoms.
Croatian: Snižavanjem srčane frekvencije, Ivabradine Anpharm ublažava napor za srce te tako usporava progresiju zatajenja srca i ublažava simptome.
English: Ivabradine Anpharm 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 Ivabradine Anpharm uspoređen je s placebom (prividnim liječenjem) i drugim terapijama u pet glavnim ispitivanja koja su uključivala više od 4000 odraslih s dugoročnom stabilnom anginom.
English: A sixth study compared Ivabradine Anpharm with placebo in 19,102 patients with coronary artery disease and without clinical heart failure.
Croatian: U šestom je ispitivanju lijek Ivabradine Anpharm uspoređen s placebom u 19 102 bolesnika s bolešću koronarnih arterija i bez kliničkog zatajenja srca.
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: Upotrebljava se u bolesnika koji se ne mogu liječiti beta-blokatorima (drugom vrstom lijeka za liječenje angine) ili u kombinaciji s betablokatorima u bolesnika čiju se bolest ne može kontrolirati samo beta-blokatorima.
English: As for all medicines, data on the use of Ivabradine Anpharm are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Ivabradine Anpharm kontinuirano se prate.
English: Ivabradine Anpharm 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: Ivabradine Anpharm se također upotrebljava u bolesnika s dugoročnim zatajenjem srca (kada srce ne opskrbljuje tijelo dovoljnom količinom krvi) i normalnim srčanim ritmom te srčanom frekvencijom od najmanje 75 otkucaja u minuti.
English: An overview of Ivabradine Anpharm and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Ivabradine Anpharm i zašto je odobren u EU-u EU-u
English: For more information about using Ivabradine Anpharm, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Ivabradine Anpharm pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.