FrancophonIA/ELRC3.0 huggingface dataset:
English: Ilaris contains the active substance canakinumab.
Croatian: Ilaris sadrži djelatnu tvar canakinumab.
English: What are the risks associated with Ilaris?
Croatian: Koji su rizici povezani s lijekom Ilaris?
English: Three studies involving 220 adults and children 2 years and older showed that Illaris was effective at reducing relapses of CAPS symptoms after a 24-week treatment period.
Croatian: Tri ispitivanja, kojima je bilo obuhvaćeno 220 odraslih osoba i djece u dobi od dvije godine i starije, pokazala su da lijek Ilaris učinkovito smanjuje ponovnu pojavu simptoma CAPS-a nakon 24 tjedna primjene.
English: − tumour necrosis factor receptor associated periodic syndrome (TRAPS);
Croatian: − periodičnog sindroma povezanog s receptorom za faktor tumorske nekroze (TRAPS)
English: The response rates with Ilaris and placebo were 46% and 8%, respectively in patients with TRAPS, 35% and 6% in patients with HIDS/MKD, and 61% and 6% in patients with FMF.
Croatian: U bolesnika s TRAPS-om stopa odgovora uz primjenu lijeka Ilaris iznosila je 46 %, u usporedbi s 8 % uz primjenu placeba, dok su u bolesnika sa sindromom HIDS/MKD te stope iznosile 35 % odnosno 6 %, a u bolesnika s FMF-om 61 % i 6 %.
English: For more information about treatment with Ilaris, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Ilaris pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: For information on doses and dose adjustments, see the summary of product characteristics (also part of the EPAR).
Croatian: Informacije o doziranju lijeka i prilagodbama doza pročitajte u sažetku opisa svojstava lijeka (također dio EPAR-a).
English: A study in 84 patients with childhood Still's disease (also known as systemic juvenile idiopathic arthritis, SJIA) found that Ilaris was more effective than placebo at reducing symptoms of arthritis: around 84% of patients who received Ilaris achieved the required reduction in symptoms, compared with about 10% of patients who received placebo.
Croatian: Ispitivanje kojim su bila obuhvaćena 84 bolesnika sa Stillovom bolešću dječje dobi (koja je poznata i kao sistemski juvenilni idiopatski artritis ili SJIA) pokazalo je da je lijek Ilaris učinkovitiji od placeba u ublažavanju simptoma artritisa: u otprilike 84 % bolesnika koji su primali lijek Ilaris ostvareno je potrebno smanjenje simptoma, u usporedbi s oko 10 % bolesnika koji su primali placebo.
English: In the two other CAPS studies, which did not compare Ilaris with any other treatment, 85% of patients on Ilaris had no relapses at all.
Croatian: U dva preostala ispitivanja CAPS-a, u kojima lijek Ilaris nije uspoređen ni s jednom drugom terapijom, u 85 % bolesnika koji su primali lijek Ilaris uopće nije zabilježena ponovna pojava bolesti.
English: In a second study in childhood Still's disease (177 patients), the risk of experiencing a disease flare was reduced by 64% with Ilaris, compared with placebo.
Croatian: U drugom ispitivanju provedenom među oboljelima od Stillove bolesti dječje dobi (177 bolesnika), rizik od rasplamsavanja bolesti smanjen je za 64 % s lijekom Ilaris u usporedbi s placebom.
English: A fourth study in 181 patients with other periodic fever syndromes found that Ilaris was more effective than placebo in achieving a response (symptoms resolved with no new flare ups).
Croatian: Četvrto ispitivanje, kojim je bio obuhvaćen 181 bolesnik s drugim sindromima periodične vrućice, pokazalo je da je lijek Ilaris učinkovitiji od placeba u postizanju odgovora (simptomi suzbijeni bez novih razbuktavanja).
English: What benefits of Ilaris have been shown in studies?
Croatian: Koje su koristi lijeka Ilaris dokazane u ispitivanjima?
English: This messenger is involved in causing inflammation and is found in high levels in patients with periodic fever syndromes, Still's disease and gouty arthritis.
Croatian: Ta glasnička molekula sudjeluje u nastanku upale, a nalazi se u visokim koncentracijama u bolesnika koji imaju sindrome periodične vrućice, Stillovu bolest ili urični artritis.
English: Studies have shown that Ilaris is effective at reducing symptoms or relapses in patients with periodic fever syndromes, Still's disease and gouty arthritis.
Croatian: Ispitivanja su pokazala da lijek Ilaris učinkovito ublažava simptome i smanjuje rizik povratka bolesti u bolesnika sa sindromima periodične vrućice, Stillovom bolešću i uričnim artritisom.
English: • Still's disease, a rare disease causing inflammation of joints as well as rash and fever (in adults and children aged 2 and above);
Croatian: • Stillove bolesti, rijetke bolesti koja uzrokuje upalu zglobova, osip i vrućicu (u odraslih i djece u dobi od dvije godine i starije);
English: How does Ilaris work?
Croatian: Kako Ilaris djeluje?
English: How is Ilaris used?
Croatian: Kako se Ilaris koristi?
English: Two studies involving 454 patients with gouty arthritis showed that Ilaris was more effective than another anti-inflammatory medicine triamcinolone acetonide at reducing pain.
Croatian: Dva ispitivanja kojima su bila obuhvaćena 454 bolesnika s uričnim artritisom pokazala su da lijek Ilaris učinkovitije smanjuje bol nego drugi protuupalni lijek naziva triamcinolon acetonid.
English: Still's disease
Croatian: Stillova bolest
English: For practical information about using Ilaris, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Ilaris bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
English: In one of the studies, none of the patients with CAPS who received Ilaris during the 24-week treatment period had a relapse, compared with 81% of patients who received placebo (a dummy treatment).
Croatian: U jednom od ispitivanja ni kod jedne od osoba oboljelih od CAPS-a koje su primale Ilaris tijekom razdoblja liječenja od 24 tjedna nije došlo do ponovne pojave bolesti, međutim to se dogodilo u 81 % bolesnika koji su primali placebo (prividno liječenje).
English: Serious infections have been observed in patients taking Ilaris.
Croatian: U bolesnika koji su uzimali lijek Ilaris uočene su ozbiljne infekcije.
English: For the full list of all side effects reported with Ilaris, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Ilaris potražite u uputi o lijeku.
English: It is used to treat the following groups:
Croatian: Koristi se za liječenje sljedećih grupa:
English: Doctors and patients must be aware of this possibility.
Croatian: Liječnici i bolesnice moraju biti svjesni ove mogućnosti.
English: The main measure of effectiveness was the number of eggs collected.
Croatian: Glavna mjera djelotvornosti bio je broj prikupljenih jajašca.
English: Previously, the FSH used in medicines was extracted from urine.
Croatian: Prethodno, FSH korišten u lijekovima ekstrahiran je iz urina.
English: What is Bemfola and what is it used for?
Croatian: Što je Bemfola i za što se koristi?
English: Bemfola follitropin alfa
Croatian: Bemfola folitropin alfa
English: The European Commission granted a marketing authorisation valid throughout the European Union for Bemfola on 27 March 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Bemfola vrijedi na prostoru Europske unije od 27. ožujka 2014.
English: The most common side effects with Bemfola (which may affect more than 1 in 10 people) are reactions at the injection site (pain, redness, bruising, swelling or irritation).
Croatian: Najčešće nuspojave lijeka Bemfola (koje se mogu javiti u više od 1 na 10 osoba) su reakcije na mjestu injekcije (bol, crvenilo, otečenost ili iritacija).
English: The full EPAR and risk management plan summary for Bemfola can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Bemfola može se naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This means that Bemfola is similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Croatian: Drugim riječima, Bemfola je sličan biološkom lijeku (poznatom kao „referentni lijek”) koji je već odobren u Europskoj uniji (EU).
English: After the first injection, the patient or their partner may give the injections themselves, if they are well motivated, have been trained and have access to expert advice.
Croatian: Nakon prve injekcije, bolesnik si može sam davati injekciju ili mu je njezin partner/njegova partnerica može davati ako su dovoljno motivirani, obučeni i imaju pristup stručnom savjetu.
English: What measures are being taken to ensure the safe and effective use of Bemfola?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Bemfola?
English: This is called ‘ovarian hyperstimulation syndrome'.
Croatian: To se naziva „sindromom hiperstimulacije jajnika”.
English: • women who are undergoing assisted reproductive techniques (fertility treatment) such as in vitro fertilisation.
Croatian: • žena koje se podvrgavaju potpomognutim reproduktivnim tehnikama (liječenju neplodnosti) poput in vitro oplodnje.
English: • men who have hypogonadotrophic hypogonadism (a rare hormone deficiency disease).
Croatian: • muškaraca koji boluju od hipogonadotropnim hipogonadizma (rijetke bolesti hormonalne deficijencije).
English: It is not intended to provide practical advice on how to use Bemfola.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Bemfola.
English: Bemfola was compared with GONAL-f in one main study involving 372 women who were undergoing assisted reproductive techniques.
Croatian: Bemfola je uspoređen s lijekom GONAL-f u jednom glavnom ispitivanju koje je obuhvatilo 372 žena koje su bile podvrgnute tehnikama potpomognute oplodnje.
English: The medicine can only be obtained with a prescription and treatment should be started under the supervision of a doctor who has experience in the treatment of fertility problems
Croatian: Ovaj se lijek izdaje samo na liječnički recept, a liječenje se treba započeti pod nadzorom liječnika s iskustvom u liječenju poremećaja plodnosti.
English: In the body, FSH controls reproductive function: in women, it stimulates the production of eggs in the ovaries; in men, it stimulates the production of sperm in the testicles.
Croatian: FSH kontrolira reproduktivnu funkciju u tijelu: u žena potiče stvaranje jajašca u jajnicima, a u muškaraca potiče stvaranje spermija u testisima.
English: Why is Bemfola approved?
Croatian: Zašto je lijek Bemfola odobren?
English: • women who do not produce eggs and who do not respond to treatment with clomiphene citrate (another medicine that stimulates the ovaries to produce eggs);
Croatian: • žena koje ne stvaraju jajašca i koje ne odgovaraju na terapiju klomifencitratom (drugim lijekom za stimuliranje jajnika na stvaranje jajašca);
English: The follitropin alfa in Bemfola, as well as in the reference product GONAL-f, is produced by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced, which makes them able to produce human FSH.
Croatian: Folitropin alfa u lijeku Bemfola, kao i u referentnom lijeku GONAL-f, proizvodi se metodom poznatom pod nazivom „tehnologijom rekombinantne DNK”: proizvodi se od stanica u koje je umetnut gen (DNK), zbog čega stanice mogu proizvoditi ljudski FSH.
English: A risk management plan has been developed to ensure that Bemfola is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Bemfola.
English: Other information about Bemfola
Croatian: Ostale informacije o lijeku Bemfola
English: In women, ovarian cysts (sacs of fluid within the ovaries) and headache are also seen in more than 1 patient in 10.
Croatian: U žena su ciste jajnika (vrećice tekućine unutar jajnika) i glavobolja uočene u više od 1 na 10 bolesnica.
English: Bemfola is a ‘biosimilar medicine'.
Croatian: Bemfola je „biosličan lijek”.
English: In women, Bemfola must not be used when there is enlargement of an ovary or a cyst that is caused by something other than polycystic ovarian disease, or when there is unexplained bleeding from the vagina.
Croatian: U žena se Bemfola ne smije koristiti ako postoji povećanje ili je cista jajnika uzrokovana nečim drugim, a ne policističnom bolešću jajnika ili ako postoji neobjašnjeno krvarenje iz vagine.
English: The study showed that Bemfola was as effective as GONAL-f at stimulating the ovaries during assisted reproductive techniques, as an average of 11 eggs were retrieved with both medicines.
Croatian: Ispitivanjem je dokazano da je lijek Bemfola bio podjednako djelotvoran u stimulaciji jajnika tijekom tehnika potpomognute oplodnje kao GONAL-f, s obzirom da je prosječno prikupljeno 11 jajašca s oba lijeka.
English: Bemfola is given by injection under the skin once a day.
Croatian: Bemfola se primjenjuje potkožnom injekcijom jednom dnevno.
English: What are the risks associated with Bemfola?
Croatian: Koji su rizici povezani s lijekom Bemfola?
English: This is a summary of the European public assessment report (EPAR) for Bemfola.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Bemfola.
English: • women with severe deficiency (very low levels) of luteinising hormone (LH) and follicle stimulating hormone (FSH).
Croatian: • žena s ozbiljnom deficijencijom (vrlo niskim razinama) luteinizirajućeg hormona (LH) i hormona koji stimulira folikule (FSH).
English: Bemfola is given to stimulate the ovaries to produce more than one egg at a time;
Croatian: Bemfola se primjenjuje za stimulaciju jajnika na proizvodnju više od jednog jajašca;
English: Bemfola must not be used in people who are hypersensitive (allergic) to follitropin alfa, FSH, or any of the other ingredients.
Croatian: Bemfola se ne smije davati osobama koje su preosjetljive (alergične) na folitropin alfa, FSH, ili na bilo koju pomoćnu tvar.
English: Bemfola is used together with human chorionic gonadotrophin (hCG) therapy to stimulate sperm production.
Croatian: Bemfola se koristi uz istovremenu terapiju humanim korionskim gonadotropinom (hCG) za stimulaciju proizvodnje sperme.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Bemfola, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku, za lijek Bemfola uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju primjenjivati.
English: The active substance in Bemfola, follitropin alfa, is a copy of the natural hormone FSH.
Croatian: Djelatna tvar u lijeku Bemfola, folitropin alfa, kopija je prirodnog hormona FSH.
English: What benefits of Bemfola have been shown in studies?
Croatian: Koje su koristi lijeka Bemfola dokazane u ispitivanjima?
English: For more information about treatment with Bemfola, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Bemfola pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Bemfola is given together with a medicine containing LH to stimulate the eggs to mature in the ovaries;
Croatian: Bemfola se primjenjuje zajedno s lijekom koji sadrži LH za stimulaciju sazrijevanja jajašca u jajnicima;
English: Bemfola is available as a solution for injection in a prefilled pen.
Croatian: Lijek Bemfola dostupan je kao otopina za injekciju u napunjenoj brizgalici.
English: The dose of Bemfola and how often it is given depend on why it is being used and on the patient's response to treatment.
Croatian: Doza lijeka Bemfola i učestalost primjene ovise o razlogu korištenja i odgovoru bolesnika na liječenje.
English: Bemfola has been shown to be comparable to the reference medicine, GONAL-f.
Croatian: Dokazano je da je lijek Bemfola usporediv s referentnim lijekom, GONAL-f.
English: Bemfola is a medicine that contains the active substance follitropin alfa.
Croatian: Bemfola je lijek koji sadrži djelatnu tvar folitropin alfa.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Bemfola has been shown to have a comparable quality, safety and effectiveness to GONAL-f.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji zaključilo je da je Bemfola dokazao kvalitetu, sigurnost i djelotvornost profila sličnog lijeku GONAL-f u skladu sa zahtjevima EU-a za bioslične lijekove.
English: How is Bemfola used?
Croatian: Kako se Bemfola koristi?
English: For practical information about using Bemfola, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Bemfola pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: For the full list of all side effects reported with Bemfola, see the package leaflet.
Croatian: Potpuni popis nuspojava koje su zabilježene s lijekom Bemfola potražite u uputi o lijeku.
English: How does Bemfola work?
Croatian: Kako djeluje Bemfola?
English: Therefore, the CHMP's view was that, as for GONAL-f, the benefits of Bemfola outweigh the identified risks.
Croatian: Stoga je CHMP mišljenja da, kao i u slučaju lijeka GONAL-f, koristi lijeka Bemfola nadmašuju s njim povezane rizike i preporučilo je njegovo odobrenje za korištenje u Europskoj uniji.
English: The reference medicine for Bemfola is GONAL-f. For more information on biosimilar medicines, see the question-and-answer document here.
Croatian: Više informacija o biosličnim lijekovima potražite u dokumentu s pitanjima i odgovorima ovdje.
English: Velmetia should not be used during pregnancy.
Croatian: Velmetia se ne smije uzimati tijekom trudnoće.
English: The safety and efficacy of Velmetia in children and adolescents from birth to < 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost lijeka Velmetia u djece i adolescenata od rođenja do < 18 godina nisu ustanovljene.
English: Velmetia with alcohol
Croatian: Velmetia s alkoholom
English: What Velmetia is and what it is used for
Croatian: Što je Velmetia i za što se koristi
English: If you stop taking Velmetia, your blood sugar may rise again.
Croatian: Ako prestanete uzimati lijek Velmetia, razina šećera u krvi može ponovno porasti.
English: Other medicines and Velmetia
Croatian: Drugi lijekovi i Velmetia
English: During treatment with Velmetia, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function.
Croatian: Tijekom liječenja lijekom Velmetia, liječnik će Vam provjeravati funkciju bubrega najmanje jedanput godišnje ili češće ako ste starija osoba i/ili ako Vam se funkcija bubrega pogoršava.
English: What Velmetia looks like and contents of the pack
Croatian: Kako Velmetia izgleda i sadržaj pakiranja
English: The following statements reflect the pharmacokinetic properties of the individual active substances of Velmetia.
Croatian: Sljedeće izjave odražavaju farmakokinetička svojstva pojedinačnih djelatnih tvari lijeka Velmetia.
English: What Velmetia contains
Croatian: Što Velmetia sadrži
English: Velmetia contains two different medicines called sitagliptin and metformin.
Croatian: Velmetia sadrži dva različita lijeka koji se zovu sitagliptin i metformin.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove
English: Date of first authorisation: 16 July 2008 Date of latest renewal: 13 March 2013
Croatian: Datum zadnje obnove: 13. ožujak 2013.
English: Your doctor will decide when you must stop and when to restart your treatment with Velmetia.
Croatian: Liječnik će odlučiti kada morate prekinuti i kada ćete nastaviti s liječenjem lijekom Velmetia.
English: If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example, in the context of an X-ray or scan, you must stop taking Velmetia before or at the time of the injection.
Croatian: Ako trebate dobiti injekciju kontrastnog sredstva koje sadrži jod u krvnu žilu, na primjer, u sklopu rendgenskog snimanja ili skeniranja, morate prestati uzimati lijek Velmetia prije ili u vrijeme injekcije.
English: Velmetia must be discontinued at the time of surgery under general, spinal or epidural anaesthesia.
Croatian: Primjena lijeka Velmetia mora se prekinuti u vrijeme kirurškog zahvata pod općom, spinalnom ili epiduralnom anestezijom.
English: Velmetia is contraindicated in patients with:
Croatian: Lijek Velmetia je kontraindiciran u bolesnika:
English: Your doctor may ask you to stop Velmetia.
Croatian: Vaš liječnik može zatražiti da prestanete s uzimanjem lijeka Velmetia.
English: If you need to have major surgery you must stop taking Velmetia during and for some time after the procedure.
Croatian: Ako se morate podvrgnuti velikom kirurškom zahvatu, morate prestati uzimati lijek Velmetia tijekom i još neko vrijeme nakon zahvata.
English: If no adequate strength of Velmetia is available, individual monocomponents should be used instead of the fixed-dose combination.
Croatian: Ako nije dostupna odgovarajuća jačina lijeka Velmetia, potrebno je primijeniti pojedinačne komponente zasebno umjesto fiksne kombinacije.
English: The level of digoxin in your blood may need to be checked if taking with Velmetia.
Croatian: Možda će biti potrebno provjeravati razinu digoksina u Vašoj krvi ukoliko se uzima s lijekom Velmetia.
English: Velmetia should be given twice daily with meals to reduce the gastrointestinal adverse reactions associated with metformin.
Croatian: Velmetia se mora uzimati dvaput na dan s hranom kako bi se smanjile gastrointestinalne nuspojave povezane s metforminom.
English: STOP taking Velmetia and contact a doctor immediately if you notice any of the following serious side effects:
Croatian: PRESTANITE uzimati lijek Velmetia i odmah se javite liječniku ako primijetite bilo koju od sljedećih ozbiljnih nuspojava:
English: If you are not sure, talk to your doctor, pharmacist or nurse before taking Velmetia.
Croatian: Ako niste sigurni, obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete lijek Velmetia.
English: Velmetia may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly.
Croatian: Velmetia može uzrokovati vrlo rijetku, ali vrlo ozbiljnu nuspojavu koja se naziva laktacidoza, osobito ako Vam bubrezi ne rade ispravno.
English: Do not take Velmetia if any of the above apply to you and talk with your doctor about other ways of managing your diabetes.
Croatian: Nemojte uzimati lijek Velmetia ako se nešto od gore navedenog odnosi na Vas i razgovarajte sa svojim liječnikom o drugim načinima na koje možete kontrolirati svoju šećernu bolest.
English: Avoid excessive alcohol intake while taking Velmetia since this may increase the risk of lactic acidosis (see section “Warnings and precautions”).
Croatian: Izbjegavajte prekomjerni unos alkohola dok uzimate lijek Velmetia jer to može povećati rizik od laktacidoze (vidjeti dio “Upozorenja i mjere opreza”).