FrancophonIA/ELRC3.0 huggingface dataset:
English: It works by blocking an enzyme called cyclooxygenase 2 (COX-2).
Croatian: Djeluje inhibirajuće na enzim naziva ciklooksigenaza 2 (COX-2).
English: If the tablets are accidentally swallowed by a person, in particular by small children, or self-injection occurs with the solution for injection, the advice of a doctor should be sought immediately.
Croatian: Ako osoba, a osobito mala djeca, slučajno proguta tabletu ili u slučaju samoinjektiranja otopinom za injekciju, potrebno je odmah potražiti savjet liječnika.
English: Hands should be washed after giving the medicine to a dog or cat.
Croatian: Potrebno je oprati ruke nakon davanja VMP-a mački ili psu.
English: The European Medicines Agency decided that Onsior's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od VMP-a Onsior nadmašuju s njim povezane rizike te da se može izdati odobrenje za njegovu primjenu u EU-u.
English: After the end of the operation, sufficient pain control was seen up to 24 hours in dogs and up to 52 hours (2 days) in cats.
Croatian: Nakon kirurškog zahvata zabilježena je zadovoljavajuća kontrola boli do 24 sata u pasa i do 52 sata (dva dana) u mačaka.
English: Why is Onsior authorised in the EU?
Croatian: Zašto je Onsior odobren u EU-u?
English: Onsior is available as tablets in five different strengths (6 mg for cats and 5 mg, 10 mg, 20 mg, and 40 mg for dogs) and as a solution for injection (20 mg/ml for dogs and cats).
Croatian: VMP Onsior dostupan je u obliku tableta u pet različitih jačina (6 mg za mačke i 5 mg, 10 mg, 20 mg, i 40 mg za pse) te u obliku otopine za injekciju (20 mg/ml za pse i mačke).
English: What are the risks associated with Onsior?
Croatian: Koji su rizici povezani s VMP-om Onsior?
English: What is Onsior and what is it used for?
Croatian: Što je Onsior i za što se koristi?
English: Pain was assessed by the veterinarian based on the animal's behaviour and responses to touching the inflamed area or moving the affected joint.
Croatian: Bol je ocjenjivao veterinar na temelju ponašanja životinje i reakcija na dodir upaljenog područja ili na pokretanje zahvaćenog zgloba.
English: The solution for injection is given as an injection under the skin to cats or dogs around 30 minutes before the start of the operation at a dose of 2 mg/kg bodyweight.
Croatian: Otopina za injekciju primjenjuje se injekcijom pod kožu u mačaka ili pasa otprilike 30 minuta prije početka kirurškog zahvata u dozi od 2 mg/kg tjelesne težine.
English: An overview of Onsior and why it is authorised in the EU
Croatian: Pregled informacija o VMP-u Onsior i zašto je odobren u EU-u
English: After surgery in cats, once daily treatment may be continued at the same dosage and at the same time every day for up to 2 days.
Croatian: Nakon kirurškog zahvata, u mačaka se liječenje jednom dnevno može nastaviti pri istoj dozi i u isto vrijeme svaki dan još najviše dva dana.
English: The solution for injection caused a gradual decrease in pain scores in cats and dogs after surgery.
Croatian: Otopina za injekciju uzrokovala je postupno smanjenje procijenjene boli u mačaka i pasa nakon kirurškog zahvata.
English: Care should be taken when treating cats or dogs with known heart or kidney problems, animals that are dehydrated and cats with liver problems.
Croatian: Potrebno je pripaziti ako se liječe mačke ili psi za koje je poznato da imaju problema sa srcem ili bubrezima, životinje koje su dehidrirale i mačke s jetrenim problemima.
English: Other information about Onsior:
Croatian: Ostale informacije o VMP-u Onsior
English: Onsior tablets given once a day reduced pain and improved mobility in both cats and dogs.
Croatian: Primjena VMP-a Onsior u tabletama jedanput na dan smanjila je bol i poboljšala pokretljivost u mačaka i pasa.
English: After surgery in cats, a daily dose may be given for up to two further days.
Croatian: Nakon kirurškog zahvata mačkama se može davati dnevna doza još najviše dva dana.
English: Onsior must not be used with other NSAIDs or with glucocorticosteroids.
Croatian: Onsior se ne smije primjenjivati s drugim nesteroidnim protuupalnim lijekovima ili glukokortikosteroidima.
English: The active substance in Onsior, robenacoxib, belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Croatian: Djelatna tvar VMP-a Onsior, robenakoksib, pripada skupini lijekova naziva nesteroidni protuupalni lijekovi (NSPUL).
English: Onsior contains the active substance robenacoxib.
Croatian: Onsior sadrži djelatnu tvar robenakoksib.
English: Treatment in cats is limited to six days for acute musculoskeletal disorders and longer term for chronic musculoskeletal disorders, with monitoring by the veterinarian.
Croatian: U mačaka je liječenje ograničeno na šest dana u slučaju akutnih mišićno-koštanih poremećaja, a dulje u slučaju kroničnih mišićno-koštanih poremećaja, uz nadzor veterinara.
English: Onsior was as effective as the comparator NSAIDs and more effective than placebo.
Croatian: VMP Onsior bio je jednako učinkovit kao i usporedni nesteroidni protuupalni lijekovi i učinkovitiji od placeba.
English: The side effects of Onsior are similar to those seen with other NSAIDs.
Croatian: Nuspojave VMP-a Onsior slične su onima zabilježenima kod drugih NSPUL-ova.
English: This enzyme is involved in producing substances called prostaglandins, which are involved in pain and inflammation.
Croatian: Taj je enzim uključen u stvaranje tvari naziva prostaglandini, koje sudjeluju u nastanku boli i upale.
English: In dogs, an increase in liver enzymes after long-term treatment with the tablets is common (which may affect up to 1 in 10 animals).
Croatian: Nakon dugotrajnog liječenja tabletama u pasa često dolazi do povišene razine jetrenih enzima (može se javiti u manje od 1 na 10 životinja).
English: Onsior is an anti-inflammatory veterinary medicine for use in cats and dogs to treat pain and inflammation.
Croatian: Onsior je protuupalni veterinarsko-medicinski proizvod (VMP) koji se primjenjuje u mačaka i pasa za liječenje boli i upale.
English: How is Onsior used?
Croatian: Kako se Onsior koristi?
English: For more information about using Onsior, see the package leaflet or contact your veterinarian or pharmacist.
Croatian: Za dodatne informacije o primjeni VMP-a Onsior pogledajte uputu o VMP-u, odnosno obratite se veterinaru ili ljekarniku.
English: In a clinical study, Onsior tablets increased the activity in 10 of 35 cats with chronic musculoskeletal disorders (as measured by activity monitors on a neck collar) and scores of behaviour, quality of life, temperament and apparent happiness of cats compared to placebo (a dummy treatment).
Croatian: Primjena VMP-a Onsior u tabletama u okviru kliničkog ispitivanja dovela je do povećane aktivnosti u 10 od 35 mačaka s kroničnim mišićno-koštanim poremećajima (izmjereno monitorom aktivnosti na ovratniku) te boljih rezultata u pogledu ponašanja, kvalitete života, naravi i vidljivog zadovoljstva mačaka, u usporedbi s placebom (prividno liječenje).
English: By blocking the production of prostaglandins, robenacoxib reduces the pain and inflammation caused by musculoskeletal disorders, surgery or osteoarthritis.
Croatian: Inhibicijom stvaranja prostaglandina robenakoksib smanjuje bol i upalu uzrokovanu mišićno-koštanim poremećajima, kirurškim zahvatom ili osteoartritisom.
English: What benefits of Onsior have been shown in studies?
Croatian: Koje su koristi VMP-a Onsior utvrđene u ispitivanjima?
English: Onsior tablets must not be used in dogs or cats with existing problems affecting the stomach and gut, such as stomach ulcers or bleeding, or in dogs with liver problems.
Croatian: Onsior u tabletama ne smije se primjenjivati u pasa ili mačaka s postojećim problemima sa želucem i crijevima kao što su čir na želucu ili gastrointestinalno krvarenje ni u pasa s jetrenim problemima.
English: In cats, the 6-mg tablet and the solution for injection can be used interchangeably when used to reduce pain and inflammation associated with orthopaedic surgery.
Croatian: U mačaka se tableta od 6 mg i otopina za injekciju mogu primjenjivati naizmjence ako se primjenjuju za smanjenje boli i upale povezane s ortopedskim kirurškim zahvatima.
English: In cats, Onsior tablets reduced moderate pain and inflammation associated with orthopaedic surgery for up to 2 days post operation when compared to animals that received placebo.
Croatian: VMP Onsior u obliku tableta smanjio je umjerenu bol i upale povezane s ortopedskim kirurškim zahvatima u mačaka do dva dana nakon kirurškog zahvata, u usporedbi sa životinjama koje su primale placebo.
English: For pregnant women, particularly those in the later stages of pregnancy, accidental ingestion or selfinjection of Onsior might be dangerous for the unborn child.
Croatian: Slučajno gutanje ili samoinjektiranje VMP-a Onsior u trudnica može biti opasno za nerođeno dijete, osobito u kasnijim stadijima trudnoće.
English: The most common side effects of the tablets and solution for injection are mild and transient effects on the stomach and gut, seen as vomiting, soft faeces and diarrhoea.
Croatian: Najčešće nuspojave tableta i otopine za injekciju su blagi i prolazni učinci na želudac i crijeva u obliku povraćanja, mekane stolice i proljeva.
English: In cats, Onsior tablets are used to treat pain and inflammation associated with acute (short term) and chronic (long term) musculoskeletal disorders (problems with the muscles and bones) and to reduce moderate pain and inflammation associated with orthopaedic (bone) surgery.
Croatian: VMP Onsior u tabletama u mačaka se primjenjuje za liječenje boli i upale povezane s akutnim (kratkotrajnim) i kroničnim (dugotrajnim) mišićno-koštanim poremećajima i za smanjenje umjerene boli i upale povezane s ortopedskim kirurškim zahvatima (kirurškim zahvatima na kostima).
English: It must not be used in animals that are pregnant, nursing puppies or kittens or being used for breeding, or that are hypersensitive (allergic) to robenacoxib or any of the other ingredients.
Croatian: Ne smije se primjenjivati u gravidnih kuja ili mačaka, onih koje doje kao ni u životinja koje su namijenjene uzgoju te koje su preosjetljive (alergične) na robenakoksib ili bilo koji drugi sastojak.
English: How does Onsior work?
Croatian: Kako djeluje Onsior?
English: Onsior was as effective as the comparator NSAIDs.
Croatian: VMP Onsior bio je jednako učinkovit kao i usporedni nesteroidni protuupalni lijekovi.
English: In dogs, Onsior tablets are used to treat pain and inflammation associated with chronic osteoarthritis (a long-term disease causing pain and inflammation in the joints).
Croatian: VMP Onsior u tabletama u pasa se primjenjuje za liječenje boli i upale povezane s kroničnim osteoartritisom (dugotrajna bolest koja uzrokuje bol i upalu zglobova).
English: The solution for injection is used to treat pain and inflammation associated with orthopaedic or soft tissue surgery.
Croatian: Otopina za injekciju primjenjuje se za liječenje boli i upale povezane s ortopedskim kirurškim zahvatima ili onima na mekom tkivu.
English: Cats should be given a single dose by mouth prior to orthopaedic surgery.
Croatian: Prije ortopedskog kirurškog zahvata mačke trebaju dobiti jednokratnu dozu kroz usta.
English: The solution for injection is used to treat pain and inflammation associated with orthopaedic or soft tissue surgery, such as neutering.
Croatian: Otopina za injekciju primjenjuje se za liječenje boli i upale povezane s ortopedskim kirurškim zahvatima ili onima na mekom tkivu, kao što je sterilizacija.
English: For a full list of side effects of Onsior, see the package leaflet.
Croatian: Potpuni popis nuspojava VMP-a Onsior potražite u uputi o VMP-u.
English: 16 December 2016
Croatian: 16. prosinca 2016.
English: The withdrawal letter is available here.
Croatian: Pismo o povlačenju dostupno je ovdje.
English: The full European Public Assessment Report for Arzerra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Arzerra nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Arzerra has been authorised since April 2010.
Croatian: Lijek Arzerra odobren je u travnju 2010.
English: What is Arzerra?
Croatian: Što je Arzerra?
English: The main measure of effectiveness was based on the number of patients who showed a partial or complete response to treatment.
Croatian: Glavna mjera djelotvornosti temeljila se na broju bolesnika koji su u cijelosti ili djelomično reagirali na liječenje.
English: On 10 November 2016, the CHMP adopted a positive opinion recommending an extension to this indication: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001131/smops/Positive/human_smop_ 001049.jsp&mid=WC0b01ac058001d127
Croatian: 1 CHMP je 10. studenoga 2016. usvojio pozitivno mišljenje kojim se preporučuje proširenje ove indikacije: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001131/smops/Positive/human_smop_ 001049.jsp&mid=WC0b01ac058001d127
English: Additionally, although some patients (39 out of 53) responded to the combination Arzerra plus bendamustine, only a few patients (6 out of 53) had a complete response, and these data were not supported by further study results.
Croatian: Osim toga, iako su neki bolesnici (39 od 53) reagirali na kombinaciju lijeka Arzerra i bendamustina, samo je nekoliko bolesnika (6 od 53) imalo potpunu reakciju, no te podatke nisu potvrdila daljnja ispitivanja.
English: What is happening with Arzerra for the treatment of other diseases?
Croatian: Koji je status lijeka Arzerra za liječenje drugih bolesti?
English: There are no consequences on the use of Arzerra in its authorised indications.
Croatian: Nema posljedica na primjenu lijeka Arzerra za odobrene indikacije.
English: By attaching to CD20, ofatumumab stimulates the body's immune system to attack the cancerous cells, helping to control the disease.
Croatian: Vezivanjem na CD20, ofatumumab stimulira imunosni sustav tijela da napada stanice raka i tako pomaže u kontroli bolesti.
English: After the CHMP had assessed the company's responses to the questions, there were still some unresolved issues.
Croatian: Nakon što je CHMP procijenio odgovore tvrtke na pitanja, još su uvijek nisu bila razjašnjena sva pitanja.
English: The company presented the results from a study involving 53 patients with relapsed CLL.
Croatian: Tvrtka je predstavila rezultate ispitivanja koje je obuhvatilo 53 bolesnika s relapsom KLL-a.
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated a list of questions.
Croatian: Zahtjev je povučen nakon što je CHMP procijenio inicijalnu dokumentaciju koju je tvrtka dostavila i sastavio popis pitanja.
English: On 8 November 2016, Novartis Europharm Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for Arzerra to be used in a new combination with bendamustine for the treatment of relapsed chronic lymphocytic leukaemia (CLL).
Croatian: Ltd 8. studenoga 2016. službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoj zahtjev za primjenu lijeka Arzerra u novoj kombinaciji s bendamustinom za liječenje relapsa kronične limfocitne leukemije (KLL).
English: Arzerra was also expected to be used in combination with bendamustine to treat adults with relapsed CLL (CLL that came back after previous treatment).
Croatian: Lijek Arzerra trebao se primjenjivati i u kombinaciji s bendamustinom za liječenje odraslih osoba s relapsom KLL-a (KLL koji se ponovno pojavio nakon prethodnog liječenja).
English: The company informed the CHMP that there are no consequences for patients currently included in or who may be joining clinical trials using Arzerra.
Croatian: Tvrtka je obavijestila CHMP da nema posljedica za bolesnike koji su u ovom trenutku uključeni u klinička ispitivanja u kojima se primjenjuje lijek Arzerra.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that its decision was based on the objections raised by the CHMP with regard to the design of the study and its patient population.
Croatian: U svojem pismu kojim obavještava Agenciju o povlačenju zahtjeva, tvrtka je navela da se njezina odluka temelji na prigovorima koje je naveo CHMP, koji su se odnosili na provedbu ispitivanja i uključene bolesnike.
English: The CHMP was concerned that the study did not compare Arzerra with any other medicine and only included 53 patients with relapsed CLL.
Croatian: CHMP je izrazio zabrinutost što se u ispitivanju lijek Arzerra nije uspoređivan s nekim drugim lijekom te što je ispitivanje obuhvatila samo 53 bolesnika s relapsom KLL-a.
English: Arzerra is a cancer medicine used to treat adults with chronic lymphocytic leukaemia (CLL), a cancer of a type of white blood cells called lymphocytes.
Croatian: Arzerra je lijek za liječenje raka koji se primjenjuje u liječenju kronične limfocitne leukemije (KLL) u odraslih, raka vrste bijelih krvnih stanica koje se nazivaju limfociti.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the results of the study were not considered to be robust and the CHMP concluded that the medicine could not have been approved based on the data presented by the company.
Croatian: U skladu s time, CHMP je u vrijeme povlačenja smatrao kako se rezultati ispitivanja ne mogu smatrati pouzdanima te je zaključio kako lijek nije moguće odobriti na temelju podataka koje je tvrtka dostavila.
English: It contains the active substance ofatumumab and is available as a concentrate that is made up into a solution for infusion (drip) into a vein.
Croatian: Sadrži djelatnu tvar ofatumumab te je dostupan kao prašak od kojeg se priprema otopina za infuziju (drip) u venu.
English: It is used together with the cancer medicines chlorambucil or bendamustine in previously untreated patients who cannot be given treatment based on another medicine, fludarabine.
Croatian: Primjenjuje se zajedno s klorambucilom ili bendamustinom (drugim lijekovima za liječenje raka) u bolesnika koji prethodno nisu liječeni, a koje se ne može liječiti terapijom na bazi fludarabina, drugog lijeka za liječenje raka.
English: What was Arzerra expected to be used for?
Croatian: Za što se lijek Arzerra trebao koristiti?
English: Based on the review of the data, at the time of the withdrawal the CHMP had some concerns and was of the provisional opinion that Arzerra could not have been approved for the treatment of relapsed CLL in combination with bendamustine.
Croatian: Na temelju pregleda podataka u trenutku povlačenja, CHMP je smatrao da postoje razlozi za zabrinutost te je njegovo privremeno mišljenje bilo da nije moguće dati odobrenje za lijek Arzerra u kombinaciji s bendamustinom za liječenje relapsa KLL-a.
English: It can also be used in patients whose disease has not responded to previous treatment with fludarabine and a medicine called alemtuzumab1.
Croatian: Također se može primjenjivati u bolesnika koji nisu reagirali na prethodno liječenje fludarabinom i alemtuzumabom.1
English: All patients received Arzerra plus bendamustine; Arzerra was not compared with any other treatment in this study.
Croatian: Svi su bolesnici uzimali lijek Arzerra i bendamustin; u tom ispitivanju liječenje lijekom Arzerra nije uspoređivano s drugim liječenjima.
English: Arzerra was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 7 November 2008 for CLL.
Croatian: Lijek Arzerra označen je 7. studenoga 2008. kao lijek za rijetke bolesti, koji se primjenjuje u liječenju KLL-a.
English: The active substance in Arzerra, ofatumumab, is a monoclonal antibody, a protein that has been designed to recognise and attach to another protein called CD20 on the surface of lymphocytes, including the cancerous lymphocytes seen in CLL.
Croatian: Djelatna tvar u lijeku Arzerra, ofatumumab, je monoklonsko protutijelo, bjelančevina koja je stvorena za prepoznavanje druge bjelančevine naziva CD20 na površini limfocita na koju se veže, uključujući limfocite zaražene rakom u KLL-u.
English: Further information on the orphan designation can be found here.
Croatian: Ovdjemožete pronaći dodatne informacije o lijekovima za rijetke bolesti.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Croatian: Tvrtka Novartis Europharm
English: • have cancer.
Croatian: • imate rak.
English: Your doctor will discuss this with you.
Croatian: Vaš liječnik će razgovarati o tome s Vama.
English: Specific radiographic findings characterise these events.
Croatian: Specifični nalazi radioloških pretraga opisuju te događaje.
English: It must be used within this 30 days period.
Croatian: Prolia se mora iskoristiti u roku od tih 30 dana.
English: Date of latest renewal: 15 January 2015
Croatian: Datum posljednje obnove odobrenja: 15. siječnja 2015.
English: • are a smoker (as this may increase the risk of dental problems).
Croatian: • ste pušač (jer to može povećati rizik od problema sa zubima).
English: Always wash your hands before every injection.
Croatian: Uvijek perite ruke prije svake injekcije.
English: Thereafter, injections should be scheduled every 6 months from the date of the last injection.
Croatian: Nakon toga, injekcije treba planirati svakih šest mjeseci od datuma zadnje injekcije.
English: It is important to try to prevent ONJ developing as it may be a painful condition that can be difficult to treat.
Croatian: Važno je pokušati spriječiti razvoj ONČ jer to može biti bolno stanje koje je teško liječiti.
English: This can eventually lead to a condition called osteoporosis.
Croatian: Ovo može na kraju voditi do stanja zvanog osteoporoza.
English: This could damage the device.
Croatian: To može oštetiti napravu.
English: Oestrogen helps keep bones healthy.
Croatian: Estrogen pomaže da kosti ostanu zdrave.
English: This will make the injection more comfortable.
Croatian: To će učiniti injekciju ugodnijom.
English: Prolia is not recommended for children and adolescents under 18 years of age.
Croatian: Prolia se ne preporuča za djecu i adolescente mlađe od 18 godina.
English: Where should you give the injection?
Croatian: Gdje trebate davati injekciju?
English: Although this imbalance was identified via a pooled analysis, it was not identified via a stratified analysis.
Croatian: Iako je ova neuravnoteženost uočena kroz združenu analizu, nije se identificirala u stratificiranoj analizi.
English: The instructions for use, handling and disposal are given in section 6.6.
Croatian: Upute za uporabu, rukovanje i zbrinjavanje dane su u dijelu 6.6.
English: DO NOT warm it in any other way, for example, in a microwave or in hot water.
Croatian: NEMOJTE je grijati na bilo koji drugi način, na primjer, u mikrovalnoj pećnici ili u vrućoj vodi.
English: Amgen Singapore Manufacturing 1 Tuas View Drive Singapore 637026
Croatian: Amgen Singapore Manufacturing 1 Tuas View Drive Singapur 637026
English: For safety reasons: Do not grasp the plunger.
Croatian: Zbog sigurnosti: Ne hvatajte klip.
English: These cases were predominantly cellulitis.
Croatian: U tim slučajevima pretežno se radilo o celulitisu.
English: In order to reduce the risk of developing ONJ, there are some precautions you should take.
Croatian: Kako bi se smanjio rizik od razvoja ONČ, trebate poduzeti neke mjere opreza.
English: Prolia is used to treat:
Croatian: Prolia se koristi u liječenju:
English: B PUSH the plunger with slow and constant pressure until you feel or hear a “snap”.
Croatian: B POGURNITE klip polaganim i postojanim pritiskom dok ne osjetite ili ne čujete “škljoc“.
English: Find a comfortable, well-lit, clean surface and put all the equipment within reach.
Croatian: Nađite udobnu, dobro osvijetljenu, čistu površinu i stavite svu opremu na dohvat ruke.
English: If you wear dentures you should make sure these fit properly.
Croatian: Ako nosite zubnu protezu trebate biti sigurni da pravilno prianja.