FrancophonIA/ELRC3.0 huggingface dataset:
English: There were significant and unresolved concerns about the risk and type of serious infections seen with tofacitinib, which are related to the immunosuppressant action of the medicine.
Croatian: Bilo je važnih i neriješenih problema s rizikom i vrstom teških infekcija primijećenih tijekom primjene tofacitiniba, koje su povezane s imunosupresivnim djelovanjem lijeka.
English: The CHMP had major concerns about the overall safety profile of Xeljanz.
Croatian: CHMP je imao ozbiljne prigovore na ukupan sigurnosni profil Xeljanza.
English: In April 2013, the Committee considered that, taken together, the data from the five main studies showed that treatment with Xeljanz resulted in an improvement in the signs and symptoms of rheumatoid arthritis and the physical function of patients.
Croatian: U travnju 2013. godine, Povjerenstvo je uzelo u obzir da su, sveukupno gledajući, podaci dobiveni iz pet glavnih ispitivanja pokazali da liječenje Xeljanzom dovodi do poboljšanja znakova i simptoma reumatoidnog artritisa kao i do poboljšanja tjelesnih funkcija bolesnika.
English: It was to be used in patients in whom treatment with at least one other medicine known as a biological disease-modifying antirheumatic drug (biological DMARD1), had been unsuccessful either because patients were unable to tolerate treatment due to side effects, or because they did not respond adequately.
Croatian: Trebali su ga koristiti bolesnici u kojih je liječenje najmanje jednim drugim lijekom poznatim kao biološki antireumatski lijek koji mijenja tijek bolesti (biološki DMARD1) bilo neuspješno, bilo zato što nisu mogli podnijeti lijek zbog nuspojava, ili zato što je liječenje bilo neučinkovito.
English: What were the CHMP's main concerns that led to the refusal?
Croatian: Koji su glavni razlozi CHMP-ova odbijanja zahtjeva?
English: What was Xeljanz expected to be used for?
Croatian: Za što se Xeljanz trebao koristiti?
English: However, the studies were not sufficient to show a consistent reduction in disease activity and structural damage to joints, particularly at the lower 5-mg dose of Xeljanz and in the target population of patients in whom treatment with at least two other DMARDs has been unsuccessful.
Croatian: Međutim, ispitivanja nisu uspjela dokazati konzistentno smanjenje aktivnosti bolesti i strukturnog oštećenja zglobova, posebice pri nižoj dozi (5 mg) Xeljanza i u ciljnoj populaciji pacijenata koji su neuspješno liječeni primjenom najmanje dva druga DMARD-a.
English: What did the company present to support its application?
Croatian: Čime je tvrtka potkrijepila zahtjev za odobrenje lijeka?
English: The company initially presented the results of five main studies of safety and effectiveness involving over 3,300 patients with rheumatoid arthritis.
Croatian: U prvom zahtjevu tvrtka je iznijela rezultate pet glavnih ispitivanja sigurnosti i djelotvornosti provedenih na 3 300 bolesnika oboljelih od reumatoidnog artritisa.
English: These studies compared Xeljanz (in a dose of 5 or 10 mg twice daily) with placebo (a dummy treatment), either alone or as an addition to other background medicines (DMARDs).
Croatian: U tim ispitivanjima uspoređivalo se djelovanje Xeljanza (u dozama od 5 ili 10 mg koje su uzimane dva puta na dan) u odnosu na placebo (slijepa proba), samostalno ili kao dodatno liječenje uz neki drugi DMARD lijek.
English: Refusal of the marketing authorisation for Xeljanz (tofacitinib)
Croatian: Uskrata odobrenja za stavljanje u promet lijeka Xeljanz (tofacitinib)
English: These safety concerns also included a risk of other severe side effects including certain cancers, gastro-intestinal perforations (holes in the wall of the gut), liver damage and problems with increased lipid (fat) levels in the blood.
Croatian: Ti su se prigovori odnosili i na rizik od drugih teških nuspojava, uključujući neke vrste karcinoma, gastrointestinalne perforacije (probušenja u stijenci tankog crijeva), oštećenje jetara te probleme s povećanom koncentracijom lipida (masti) u krvi.
English: How is Xeljanz expected to work?
Croatian: Kako bi Xeljanz trebao djelovati?
English: Xeljanz was expected to be used in the treatment of moderate to severe active rheumatoid arthritis (an immune system disease causing damage and inflammation in the joints).
Croatian: Predviđena uporaba Xeljanza bila je liječenje umjerenog do teškog aktivnog reumatskog artritisa (bolesti imunološkog sustava koja uzrokuje oštećenje i upalu zglobova).
English: The active substance in Xeljanz, tofacitinib, is an immunosuppressant (a medicine that reduces the activity of the immune system) that works by blocking the action of enzymes known as Janus kinases.
Croatian: Djelatna tvar Xeljanza - tofacitinib je imunosupresiv (lijek koji smanjuje aktivnost imunološkog sustava) koji inhibira djelovanje enzima tzv. Janus kinaza.
English: On 25 April 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Xeljanz, intended for the treatment of rheumatoid arthritis.
Croatian: Povjerenstvo za humane lijekove Europske agencije za lijekove (CHMP) usvojilo je negativno mišljenje, te preporučilo da se uskrati odobrenje za stavljanje u promet lijeka Xeljanz, namijenjenog liječenju reumatoidnog artritisa.
English: Therefore, in April 2013 the CHMP was of the opinion that the benefits of Xeljanz did not outweigh its risks and recommended that it be refused marketing authorisation.
Croatian: Stoga je u travnju 2013. godine mišljenje CHMP-a bilo da odnos koristi i rizika Xeljanza nije pozitivan, pa su preporučili uskratu odobrenja za stavljanje u promet.
English: The effects of Xeljanz were first tested in experimental models before being studied in humans.
Croatian: Prije provođenja ispitivanja na ljudima, učinci Xeljanza ispitani su na eksperimentalnim modelima.
English: By blocking the enzymes, tofacitinib is expected to reduce the inflammation and other symptoms of the disease.
Croatian: Tofacitinib bi inhibicijom ovih enzima trebao ublažiti upalu i druge simptome bolesti.
English: The main measures of effectiveness were changes in patient scores for signs and symptoms of disease, physical function of the patient, structural damage to joints and disease activity; these were measured after 3 or 6 months, depending on the study.
Croatian: Glavne mjere učinkovitosti bile su promjene u ocjenama kojima su bolesnici ocjenjivali znakove i simptome bolesti, u tjelesnim funkcijama pacijenata, strukturnom oštećenju zglobova te u aktivnosti bolesti.
English: Xeljanz is a medicine that contains the active substance tofacitinib.
Croatian: Xeljanz je lijek čija je djelatna tvar tofacitinib.
English: These enzymes play an important role in the process of inflammation and damage of the joints that occurs in rheumatoid arthritis.
Croatian: Ti su enzimi važni za upalu i oštećenja
English: 30 months.
Croatian: 30 mjeseci.
English: The potential risk for humans is unknown.
Croatian: Potencijalni rizik za ljude nije poznat.
English: You may need medical treatment.
Croatian: Možda ćete trebati medicinski tretman.
English: Then follow the instructions below:
Croatian: Potom slijedite niže navedene upute:
English: This usually goes away over time.
Croatian: Obično prolazi s vremenom.
English: • At the request of the European Medicines Agency;
Croatian: • na zahtjev Europske agencije za lijekove
English: All patients recovered without complications.
Croatian: Svi bolesnici oporavili su se bez komplikacija.
English: After first use: 1 month.
Croatian: Nakon prve primjene: 1 mjesec.
English: Before opening:
Croatian: Prije otvaranja:
English: These reactions have usually been mild.
Croatian: Ove reakcije su obično bile blage.
English: Then take your next dose as usual the following day.
Croatian: Potom primijenite sljedeću dozu kako je uobičajeno sljedeći dan.
English: This is normal and does not affect your dose.
Croatian: To je normalno i nema učinka na Vašu dozu.
English: You can give yourself the injection at any time of the day, regardless of meals.
Croatian: Injekciju si možete dati u bilo koje doba dana, bez obzira na obroke.
English: During use:
Croatian: Tijekom uporabe:
English: The CHMP agrees with the scientific conclusions made by the PRAC.
Croatian: CHMP je suglasan sa znanstvenim zaključcima koje je donio PRAC.
English: This reduction was observed within the first two weeks of treatment.
Croatian: Ovo sniženje zabilježeno je unutar prva dva tjedna liječenja.
English: Please see section 4 for the warning signs of low blood sugar.
Croatian: Pogledajte dio 4. za znakove upozorenja na nizak šećer u krvi.
English: Time from randomisation (months)
Croatian: Vrijeme od randomizacije (mjeseci)
English: This indicates the pen is defective and you must use a new one.
Croatian: To ukazuje da je brizgalica neispravna pa morate upotrijebiti novu.
English: • if you have or have had a disease of the pancreas.
Croatian: • ako imate ili ste imali bolest gušterače.
English: It also slows food passage through your stomach and can help prevent heart disease.
Croatian: Ona također usporava prolazak hrane kroz želudac i može pomoći spriječiti bolest srca.
English: The duration of observation was a minimum of 3.5 years and up to a maximum of 5 years.
Croatian: Praćenje je trajalo najmanje 3,5 godina, a najviše 5 godina.
English: What Victoza is and what it is used for
Croatian: Što je Victoza i za što se koristi
English: Always use a new needle for each injection.
Croatian: Uvijek upotrijebite novu iglu za svaku injekciju.
English: Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs.
Croatian: Liječnik će Vam reći kako liječiti nizak šećer u krvi i što učiniti primijetite li te znakove upozorenja.
English: These reactions usually diminish within a few days or weeks on continued treatment.
Croatian: Ove reakcije se obično smanjuju unutar nekoliko dana ili tjedana neprekidnog liječenja.
English: It is important to avoid dehydration by drinking plenty of fluids.
Croatian: Važno je izbjeći dehidraciju tako što ćete piti puno tekućine.
English: Do not inject it into a vein or muscle.
Croatian: Nemojte je injicirati u venu ili mišić.
English: Important information
Croatian: Važne informacije
English: The relevance for humans is likely to be low but cannot be completely excluded.
Croatian: Važnost tih nalaza za ljude je vjerojatno mala, ali se ne može u potpunosti isključiti.
English: Contact your doctor if you have any questions or concerns.
Croatian: Kontaktirajte svog liječnika ako imate bilo kakvih pitanja ili nedoumica.
English: Use a calculator to plan the doses.
Croatian: Koristite kalkulator za planiranje doza.
English: Hazard Ratio (95% CI)
Croatian: Omjer hazarda (95% CI)
English: These tumours were not seen in monkeys treated for 20 months.
Croatian: Ovi tumori nisu zabilježeni u majmuna liječenih tijekom 20 mjeseci.
English: It also ensures that the dosing is accurate.
Croatian: Time se također osigurava točno doziranje.
English: Patients at risk
Croatian: Bolesnici s rizikom
English: Novo Nordisk A/S Hallas Allé DK-4400 Kalundborg Denmark
Croatian: Novo Nordisk A/S Hallas Allé DK-4400 Kalundborg
English: • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
Croatian: • kao monoterapija kada se metformin ne smatra prikladnim zbog nepodnošljivosti ili kontraindikacija
English: Do not change your dose unless your doctor has told you to.
Croatian: Nemojte mijenjati dozu lijeka ako Vam liječnik to nije rekao.
English: Patients with an event (%)
Croatian: Bolesnici s događajem (%)
English: Novo Nordisk A/S
Croatian: DRUGO Novo Nordisk A/S
English: • The starting dose is 0.6 mg once a day, for at least one week.
Croatian: • Početna doza je 0,6 mg jedanput na dan, kroz najmanje jedan tjedan.
English: Pancreatitis can be a serious, potentially life-threatening medical condition.
Croatian: Pankreatitis može biti ozbiljno medicinsko stanje, potencijalno opasno po život.
English: However, it is preferable that Victoza is injected around the same time of the day, when the most convenient time of the day has been chosen.
Croatian: Međutim, bolje je lijek Victoza injicirati otprilike u isto doba dana, kad se odabere najprimjerenije doba dana.
English: Victoza should not be used if it has been frozen.
Croatian: Victoza se ne smije koristiti ako je bila zamrznuta.
English: Patients should be informed of the characteristic symptoms of acute pancreatitis.
Croatian: Bolesnike treba obavijestiti o karakterističnim simptomima akutnog pankreatitisa.
English: If you split the dose wrong, you may inject too much or too little liraglutide.
Croatian: Ako pogrešno razdijelite dozu, mogli biste injicirati previše ili premalo liraglutida.
English: • Keep your pen out of the reach of others, especially children.
Croatian: • Držite brizgalicu izvan dohvata drugih osoba, osobito djece.
English: Please consult your doctor for further information on this topic.
Croatian: Posavjetujte se s liječnikom kako biste dobili dodatne podatke o ovoj temi.
English: Needles are not included.
Croatian: Igle nisu priložene.
English: Split your dose into two injections:
Croatian: Razdijelite Vašu dozu u dvije injekcije:
English: The mean duration of diabetes was 12.8 years.
Croatian: Srednja vrijednost trajanja šećerne bolesti iznosila je 12,8 godina.
English: Your doctor may reduce your dose of these medicines before you start using Victoza.
Croatian: Liječnik Vam može smanjiti dozu ovih lijekova prije nego započnete s primjenom lijeka Victoza.
English: This is to make sure that you get your full dose.
Croatian: Tako ćete biti sigurni da ste primili cijelu dozu.
English: p<0.001 for non-inferiority p=0.005 for superiority
Croatian: p<0,001 za neinferiornost p=0,005 za superiornost
English: No data are available in children below 10 years of age.
Croatian: Nema dostupnih podataka u djece mlađe od 10 godina.
English: No other treatment-related tumours have been found.
Croatian: Nisu nađeni nikakvi drugi tumori povezani s liječenjem.
English: Weight loss was sustained.
Croatian: Gubitak tjelesne težine se održao.
English: Do not take an extra dose or increase the dose on the following day to make up for the missed dose.
Croatian: Nemojte uzeti dodatnu dozu niti povećati dozu sljedeći dan kako biste nadoknadili propuštenu dozu.
English: Interaction studies have only been performed in adults.
Croatian: Ispitivanja interakcija provedena su samo u odraslih osoba.
English: Do not stop using Victoza without talking to your doctor.
Croatian: Nemojte prestati primjenjivati lijek Victoza bez razgovora s liječnikom.
English: If you stop using it, your blood sugar levels may increase.
Croatian: Ako ga prestanete primjenjivati, razina šećera u krvi može Vam se povisiti.
English: Very rare
Croatian: Vrlo rijetko
English: However, if it is more than 12 hours since you should have used Victoza, skip the missed dose.
Croatian: Međutim, ako je prošlo više od 12 sati od vremena kad ste trebali primijeniti lijek Victoza, preskočite propuštenu dozu.
English: Pancreatitis (including necrotising pancreatitis)
Croatian: Pankreatitis (uključujući nekrotizirajući pankreatitis)
English: • in addition to other medicinal products for the treatment of diabetes.
Croatian: • kao dodatak drugim lijekovima za liječenje šećerne bolesti
English: No data are available for children below 10 years of age (see sections 5.1 and 5.2).
Croatian: Nema dostupnih podataka u djece mlađe od 10 godina (vidjeti dijelove 5.1 i 5.2).
English: • Risk Management Plan
Croatian: • Plan upravljanja rizikom (RMP)
English: The injection site and timing can be changed without dose adjustment.
Croatian: Mjesto i vrijeme injiciranja mogu se mijenjati bez prilagođavanja doze.
English: Do not use the cartridge scale to measure how much liraglutide to inject - it is not accurate enough.
Croatian: Nemojte koristiti skalu na ulošku za mjerenje količine liraglutida koju ćete injicirati - to nije dovoljno točno.
English: Before you use the pen for the first time, your doctor or nurse will show you how to use it.
Croatian: Prije prve uporabe brizgalice liječnik ili medicinska sestra pokazat će Vam kako je upotrebljavati.
English: Be careful not to bend or damage the needle.
Croatian: Pazite da ne savijete ili oštetite iglu.
English: • Do not try to wash, soak or lubricate it - this can harm the pen.
Croatian: • Nemojte je pokušavati prati, namakati ili podmazivati - to može oštetiti brizgalicu.
English: Using the wrong medicine could cause severe harm.
Croatian: Primjena krivog lijeka može uzrokovati teške posljedice.
English: Please tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Date of first authorisation: 30 June 2009 Date of last renewal: 11 April 2014
Croatian: Datum posljednje obnove odobrenja: 11. travnja 2014.
English: For further instructions on administration, see section 6.6.
Croatian: Za daljnje upute za primjenu, vidjeti dio 6.6.
English: Liraglutide is extensively bound to plasma proteins (>98%).
Croatian: Liraglutid se u velikoj mjeri veže za proteine plazme (>98%).
English: Warfarin and other coumarin derivatives
Croatian: Varfarin i drugi kumarinski derivati
English: If you experience these symptoms you should seek immediate medical help and inform your doctor as soon as possible.
Croatian: Ako osjetite ove simptome, morate odmah zatražiti medicinsku pomoć i što prije obavijestiti svog liječnika.
English: No adjustment
Croatian: Nema prilagodbe
English: Increased lipase*
Croatian: Povišena lipaza*
English: Low blood sugar (hypoglycaemia) may reduce your ability to concentrate.
Croatian: Niska razina šećera u krvi (hipoglikemija) može umanjiti Vašu sposobnost koncentracije.
English: Avoid driving or using machines if you experience signs of hypoglycaemia.
Croatian: Izbjegavajte upravljanje vozilima ili strojevima ako osjetite znakove hipoglikemije.
English: If a patient wishes to become pregnant, or pregnancy occurs, treatment with Victoza should be discontinued.
Croatian: Ako bolesnica planira trudnoću ili zatrudni, liječenje lijekom Victoza treba prekinuti.
English: • Dehydration, sometimes with a decrease in kidney function
Croatian: • Dehidracija, ponekad sa smanjenjem bubrežne funkcije
English: After at least one week, the dose should be increased to 1.2 mg.
Croatian: Poslije najmanje jednog tjedna dozu treba povisiti na 1,2 mg.
English: Frequencies for all events have been calculated based on their incidence in phase 3a clinical trials.
Croatian: Učestalosti svih događaja izračunate su na osnovu njihove incidencije u kliničkim ispitivanjima faze 3a.
English: No interaction study has been performed.
Croatian: Nije provedeno ispitivanje interakcije.
English: • Hypoglycaemia (low blood sugar).
Croatian: • Hipoglikemija (niska razina šećera u krvi).
English: Frequencies are defined as: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Croatian: Učestalost je definirana kao: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Then prepare a new pen for injection and inject the remaining number of mg to complete your dose.
Croatian: Potom pripremite novu brizgalicu za injiciranje i injicirajte preostali broj mg kako biste dopunili svoju dozu.
English: If no drop appears, repeat steps E to G up to four times.
Croatian: Ako se kapljica ne pojavi, ponavljajte korake E do G do četiri puta.
English: Infections and infestations
Croatian: Infekcije i infestacije
English: Headache and nasopharyngitis were also common.
Croatian: Glavobolja i nazofaringitis bili su također česti.
English: Victoza should not be used during pregnancy because it is not known if it may harm your unborn child.
Croatian: Victoza se ne smije primjenjivati tijekom trudnoće jer nije poznato može li naštetiti Vašem nerođenom djetetu.
English: Other clinical data
Croatian: Drugi klinički podaci
English: 2 IU a According to the individualised recommendation by the investigator at the previous visit, for example depending on whether the patient has experienced hypoglycaemia.
Croatian: Prema individualiziranoj preporuci ispitivača kod posljednjeg posjeta, primjerice, ovisno o tome je li bolesnik imao hipoglikemiju.
English: It is not an insulin and should therefore not be used as a substitute for insulin.
Croatian: To nije inzulin i stoga se ne smije koristiti kao zamjena za inzulin.
English: If your pen is already in use, go to ‘Select your dose', step H.
Croatian: Ako je brizgalica već u upotrebi, prijeđite na dio ‘Odabir doze', korak H.
English: • Do not try to repair your pen or pull it apart.
Croatian: • Nemojte pokušavati popraviti brizgalicu ili je rastavljati.
English: In the event of overdose, appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms.
Croatian: U slučaju predoziranja treba započeti odgovarajuće potporno liječenje prema bolesnikovim kliničkim znakovima i simptomima.
English: • Do not share your pen or needles with anyone else.
Croatian: • Nemojte dijeliti svoju brizgalicu i igle s drugim osobama.
English: Non-clinical data reveal no special hazards for humans based on conventional studies of safety pharmacology, repeat-dose toxicity or genotoxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza ili genotoksičnosti.
English: Clear and colourless or almost colourless, isotonic solution; pH=8.15.
Croatian: Bistra i bezbojna ili gotovo bezbojna, izotonična otopina; pH=8,15.
English: ATC code: A10BJ02
Croatian: ATK oznaka: A10BJ02.
English: Two minor plasma metabolites were detected (≤9% and ≤5% of total plasma radioactivity exposure).
Croatian: Otkrivena su dva manja metabolita u plazmi (≤9% i ≤5% ukupne izloženosti plazme radioaktivnosti).
English: Stop taking Victoza and contact a doctor immediately if you notice any of the following serious side effects:
Croatian: Prestanite primjenjivati lijek Victoza i odmah se obratite liječniku ako primijetite bilo koju od navedenih ozbiljnih nuspojava:
English: It helps your body reduce your blood sugar level only when blood sugar is too high.
Croatian: Ona pomaže Vašem organizmu da snizi razinu šećera u krvi samo onda kad je šećer u krvi previsok.
English: If you forget a dose, use Victoza as soon as you remember.
Croatian: Ako ste zaboravili primijeniti jednu dozu, primijenite lijek Victoza čim se sjetite.
English: If you have dropped your pen against a hard surface or suspect that something is wrong with it, always put on a new disposable needle and check the flow before you inject.
Croatian: Ako Vam je brizgalica ispala na tvrdu površinu ili sumnjate da s njom nešto nije u redu, uvijek stavite novu jednokratnu iglu i provjerite protok prije injiciranja.
English: Liraglutide is metabolised in a similar manner to large proteins without a specific organ having been identified as major route of elimination.
Croatian: Liraglutid se metabolizira na sličan način kao i veliki proteini, te nije utvrđen nijedan specifični organ kao glavni put eliminacije.
English: Screw the needle straight and tightly onto your pen.
Croatian: Navijte iglu ravno i čvrsto na brizgalicu.
English: Both treatments resulted in mean body weight loss of approximately 3 kg.
Croatian: Oba liječenja rezultirala su srednjom vrijednošću gubitka tjelesne težine za otprilike 3 kg.
English: Apart from a slight decrease in the number of live implants, animal studies did not indicate harmful effects with respect to fertility.
Croatian: Osim neznatnog sniženja broja živih implantata, ispitivanja na životinjama nisu ukazala na štetne učinke na plodnost.
English: Do not use the pen if a drop of liraglutide still does not appear.
Croatian: Nemojte koristiti brizgalicu ako se kapljica liraglutida i dalje ne pojavljuje.