FrancophonIA/ELRC3.0 huggingface dataset:
English: Iclusig is used in patients who cannot tolerate or do not respond to dasatinib (patients with CML or ALL) or nilotinib (patients with CML), which are other cancer medicines of the same class, and for whom subsequent treatment with imatinib (a third such medicine) is not considered appropriate.
Croatian: Iclusig se koristi u bolesnika koji ne podnose ili ne reagiraju na liječenje dasatinibom (za bolesnike s KML-om ili ALL-om) ili nilotinibom, koji su drugi lijekovi istog razreda protiv raka i kod kojih se naknadno liječenje imatinibom (trećim takvim lijekom) ne smatra odgovarajućim.
English: The active substance in Iclusig, ponatinib, belongs to a group of medicines called ‘tyrosine kinase inhibitors'.
Croatian: Djelatna tvar u lijeku Iclusig, ponatinib, pripada skupini lijekova zvanih „inhibitori tirozin kinaze”.
English: Iclusig is a cancer medicine that contains the active substance ponatinib.
Croatian: Iclusig je lijek protiv karcinoma koji sadrži djelatnu tvar ponatinib.
English: How does Iclusig work?
Croatian: Kako djeluje Iclusig?
English: Iclusig was shown to be an effective treatment for those patients with CML or Ph+ ALL who have limited treatment options.
Croatian: Pokazalo se da Iclusig predstavlja djelotvorno liječenje za one bolesnike s KML-om ili ALL-om Ph+ kojima su mogućnosti liječenja ograničene.
English: These compounds act by blocking enzymes known as tyrosine kinases.
Croatian: Te tvari djeluju blokirajući enzime zvane tirozin kinaze.
English: What benefits of Iclusig have been shown in studies?
Croatian: Koje su koristi od lijeka Iclusig utvrđene u ispitivanjima?
English: Iclusig has been investigated in one main study involving 449 patients with CML or Ph+ ALL and who were intolerant or resistant to treatment with dasatinib or nilotinib, or had the T315I mutation.
Croatian: Iclusig je ispitivan u jednom glavnom ispitivanju koje je uključivalo 449 bolesnika s KML-om ili ALL-om Ph+ koji nisu podnosili liječenje ili nisu reagirali na liječenje dasatinibom, odnosno nilotinibom ili su imali mutaciju T315I.
English: Serious venous occlusive adverse events (clots or blockages in the veins) occurred in 5% of patients.
Croatian: Ozbiljni venski okluzivni štetni događaj (ugrušci ili začepljenja u venama) pojavili su se u 5 % bolesnika.
English: Iclusig can lead to clots or blockages in arteries and veins and patients should have the condition of their heart and circulation considered before starting and during treatment, and be treated appropriately for any problems.
Croatian: Iclusig može uzrokovati ugruške ili začepljenja u arterijama i venama te je prije početka i tijekom liječenja potrebno provjeriti status srca i krvotoka bolesnika te ga liječiti na odgovarajući način ako je potrebno.
English: • among the patients with Ph+ ALL, around 41% (13 out of 32) had a major haematological response.
Croatian: • među bolesnicima s ALL-om Ph+ otprilike 41 % (13 od 32 bolesnika) imalo je značajan hematološki odgovor.
English: • among the patients with CML in the chronic phase, around 54% (144 out of 267) had a major cytogenetic response;
Croatian: • među bolesnicima s KML-om u kroničnoj fazi otprilike 54 % (144 od 267 bolesnika) imalo je značajan citogenetski odgovor;
English: • among the patients with CML in the accelerated phase, around 58% (48 out of 83) had a major haematological response;
Croatian: • među bolesnicima s KML-om u ubrzanoj fazi otprilike 58 % (48 od 83 bolesnika) imalo je značajan hematološki odgovor;
English: • among the patients with CML in the blast phase, around 31% (19 out of 62) had a major haematological response;
Croatian: • među bolesnicima s KML-om u blastičnoj fazi otprilike 31 % (19 od 62 bolesnika) imalo je značajan hematološki odgovor;
English: For the full list of side effects and restrictions with Iclusig, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Iclusig potražite u uputi o lijeku.
English: The usual dose is one infusion of 4 mg over at least 15 minutes.
Croatian: Uobičajena doza lijeka je jedna infuzija od 4 mg tijekom najmanje 15 minuta.
English: This reduces bone loss.
Croatian: Time se smanjuje gubitak kosti.
English: Further information on Zoledronic Acid Accord can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/zoledronic-acid-accord.
Croatian: Više informacija o lijeku Zoledronatna kiselina Accord možete naći na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/zoledronic-acid-accord.
English: Patients with tumours can have high levels of calcium in their blood, released from the bones.
Croatian: Bolesnici s tumorima mogu imati visoku razinu kalcija u krvi koja se otpušta iz kostiju.
English: This means that Zoledronic Acid Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Zometa.
Croatian: To znači da Zoledronatna kiselina Accord sadrži istu djelatnu tvar i djeluje na jednak način kao i „referentni lijek” koji je već odobren u Europskoj uniji (EU) pod nazivom Zometa.
English: This includes fractures (breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders needing radiotherapy (treatment with radiation) or surgery, and hypercalcaemia (high levels of calcium in the blood).
Croatian: To uključuje prijelome (lomove u kostima), kompresiju kralježaka (kada kost pritišće kralježničnu moždinu), koštane poremećaje koji zahtijevaju radioterapiju (liječenje zračenjem) ili kirurški zahvat, te hiperkalcemiju (visoku razinu kalcija u krvi).
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Zometa, and do not need to be repeated for Zoledronic Acid Accord.
Croatian: Ispitivanja koristi i rizika od djelatne tvari u odobrenim primjenama već su provedena s referentnim lijekom Zometa i stoga ih nije potrebno ponavljati za lijek Zoledronatna kiselina Accord.
English: Because Zoledronic Acid Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicines'.
Croatian: Budući da je Zoledronatna kiselina Accord generički lijek, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue.
Croatian: Ona zaustavlja djelovanje osteoklasta, stanica u tijelu koje su uključene u razgradnju koštanog tkiva.
English: There was no need for ‘bioequivalence' studies to investigate whether Zoledronic Acid Accord is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Croatian: Nisu bila potrebna ispitivanja „bioekvivalencije” kako bi se istražilo apsorbira li se lijek Zoledronatna kiselina Accord na sličan način kao referentni lijek radi proizvodnje jednake razine djelatne tvari u krvi.
English: It is not recommended for patients with severely reduced kidney function.
Croatian: Primjena lijeka ne preporučuje se u bolesnika s iznimno smanjenom funkcijom bubrega.
English: By preventing the breakdown of bones, Zoledronic Acid Accord also helps to reduce the amount of calcium released into the blood.
Croatian: Sprečavanjem razgradnje kostiju lijek Zoledronatna kiselina Accord pridonosi i smanjenju količine kalcija koja se otpušta u krv.
English: Osteonecrosis of the jaw is a condition affecting the bones of the jaw, which could lead to pain, sores in the mouth or loose teeth.
Croatian: Osteonekroza čeljusti bolest je koja zahvaća kosti čeljusti, što može dovesti do boli, rana u ustima i gubitka zuba.
English: Side effects reported with Zoledronic Acid Accord are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Zoledronatna kiselina Accord pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zoledronic Acid Accord have also 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 Zoledronatna kiselina Accord nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Therefore, the Agency's view was that, as for Zometa, the benefit outweighs the identified risk and it can be authorised for use in the EU.
Croatian: Stoga je stav Agencije da korist od lijeka, kao i kod lijeka Zometa, nadmašuje identificirani rizik te da lijek može biti odobren za primjenu u EU-u.
English: The medicine is given as an infusion (drip) into a vein.
Croatian: Lijek se daje intravenskom infuzijom (ukapavanje).
English: The company that markets Zoledronic Acid Accord will provide a card to inform patients receiving Zoledronic Acid Accord about the risk of osteonecrosis of the jaw and to instruct them to contact their doctor if they get symptoms.
Croatian: Tvrtka koja stavlja lijek Zoledronatna kiselina Accord u promet bolesnicima će osigurati informativnu karticu o riziku od osteonekroze čeljusti te ih uputiti da se obrate liječniku ako osjete navedene simptome.
English: Zoledronic Acid Accord can also be used to treat hypercalcaemia caused by tumours.
Croatian: Zoledronatna kiselina Accord može se primjenjivati i za liječenje hiperkalcemije uzrokovane tumorima.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Zoledronic Acid Accord has been shown to have comparable quality and to be comparable to Zometa.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, utvrđeno je da lijek Zoledronatna kiselina Accord posjeduje usporedivu kakvoću te da je bioekvivalentan s lijekom Zometa.
English: Zoledronic Acid Accord can only be obtained with a prescription and must only be prescribed and given by a healthcare professional who has experience in the use of this type of medicine given into a vein.
Croatian: Zoledronatna kiselina Accord izdaje se samo na liječnički recept i mora ga propisivati i davati zdravstveni radnik s iskustvom u intravenskoj primjeni ove vrste lijeka.
English: Zoledronic Acid Accord received a marketing authorisation valid throughout the EU on 16 January
Croatian: Lijek Zoledronatna kiselina Accord dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 16. siječnja 2014.
English: What measures are being taken to ensure the safe and effective use of Zoledronic Acid Accord?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Zoledronatna kiselina Accord?
English: An overview of Zoledronic Acid Accord and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Zoledronatna kiselina Accord i zašto je odobren u EU-u
English: The reduction of bone loss helps to make bones less likely to break, which is useful in preventing fractures in cancer patients with bone metastases.
Croatian: Smanjenje gubitka kosti pridonosi smanjenju lomljivosti kostiju, što pomaže u sprečavanju prijeloma u bolesnika oboljelih od raka i s metastazama kostiju.
English: For more information about using Zoledronic Acid Accord, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Zoledronatna kiselina Accord pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Zoledronic Acid Accord is a medicine used to prevent bone complications in adults with advanced cancer that is affecting the bone.
Croatian: Zoledronatna kiselina Accord lijek je za sprječavanje koštanih komplikacija u odraslih osoba s uznapredovalim rakom koji zahvaća kost.
English: Zoledronic Acid Accord (zoledronic acid)
Croatian: Zoledronatna kiselina Accord (zoledronatna kiselina)
English: As for every medicine, the company provided studies on the quality of Zoledronic Acid Accord.
Croatian: Kao i za svaki lijek, tvrtka je dostavila podatke o ispitivanju kakvoće lijeka Zoledronatna kiselina Accord.
English: This is because Zoledronic Acid Accord is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Croatian: Razlog tome je činjenica da se Zoledronatna kiselina Accord daje intravenskom infuzijom i stoga djelatna tvar odmah ulazi u krvotok.
English: Zoledronic Acid Accord contains the active substance zoledronic acid and is a ‘generic medicine'.
Croatian: Lijek Zoledronatna kiselina Accord sadrži djelatnu tvar zoledronatnu kiselinu te je „generički lijek”.
English: Other information about Zoledronic Acid Accord
Croatian: Ostale informacije o lijeku Zoledronatna kiselina Accord
English: What are the benefits and risks of Zoledronic Acid Accord?
Croatian: Koje su koristi i rizici od lijeka Zoledronatna kiselina Accord?
English: As for all medicines, data on the use of Zoledronic Acid Accord are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Zoledronatna kiselina Accord kontinuirano se prate.
English: What is Zoledronic Acid Accord and what is it used for?
Croatian: Što je Zoledronatna kiselina Accord i za što se primjenjuje?
English: The active substance in Zoledronic Acid Accord, zoledronic acid, is a bisphosphonate.
Croatian: Djelatna tvar u lijeku Zoledronatna kiselina Accord, zoledronatna kiselina, ubraja se u bisfosfonate.
English: Why is Zoledronic Acid Accord authorised in the EU?
Croatian: Zašto je lijek Zoledronatna kiselina Accord odobren u EU-u?
English: When used to prevent bone complications, the infusion can be repeated every three to four weeks, and patients should also take supplements of calcium and vitamin D. A lower dose is recommended for patients with bone metastases (when cancer has spread to the bone) if they have mild to moderately reduced kidney function.
Croatian: Kada se primjenjuje za sprečavanje koštanih komplikacija, infuzija se može ponavljati svakih tri do četiri tjedna i bolesnici trebaju uzimati dodatke kalcija i vitamina D.
English: How does Zoledronic Acid Accord work?
Croatian: Kako djeluje Zoledronatna kiselina Accord?
English: How is Zoledronic Acid Accord used?
Croatian: Kako se Zoledronatna kiselina Accord primjenjuje?
English: How has Zoledronic Acid Accord been studied?
Croatian: Kako je Zoledronatna kiselina Accord ispitivan?
English: This will help protect against the disease.
Croatian: To pomaže u zaštiti od bolesti.
English: This summary was last updated in June 2017.
Croatian: Sažetak je posljednji put ažuriran u lipnju 2017.
English: Protection starts 21 days after vaccination and lasts for 112 days.
Croatian: Zaštita započinje 21 dan nakon cijepljenja i traje 112 dana.
English: What is Vepured and what is it used for?
Croatian: Što je Vepured i za što se koristi?
English: The full EPAR for Vepured can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za VMP Vepured nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Other information about Vepured:
Croatian: Ostale informacije o VMP-u Vepured:
English: Oedema disease is found worldwide and usually occurs in the first few weeks of life of the piglets.
Croatian: Edemska bolest ustanovljena je diljem svijeta, a obično nastaje u prvih nekoliko tjedana života prasadi.
English: Why is Vepured approved?
Croatian: Zašto je Vepured odobren?
English: Vepured also reduced the weight loss of pigs in herds affected with the disease.
Croatian: Vepured je također smanjio gubitak težine u prasadi u uzgoju koji je zahvatila bolest.
English: It is not intended to provide practical advice on how to use Vepured.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju VMP-a Vepured.
English: In the future, if the animals are exposed to the bacteria producing the unmodified toxin, their immune system will be able to make antibodies against the toxin more quickly.
Croatian: Ubuduće, ako su životinje izložene bakteriji koja proizvodi nemodificirani toksin, njihov će imunosni sustav brže moći proizvesti protutijela protiv toga toksina.
English: The withdrawal period for meat from pigs treated with Vepured is ‘zero' days, which means there is no mandatory waiting time.
Croatian: Razdoblje karencije za meso svinja liječenih VMP-om Vepured iznosi „nula dana”, drugim riječima, nema obveznog perioda čekanja.
English: The European Commission granted a marketing authorisation valid throughout the EU for Vepured on 17 August 2017.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za VMP Vepured na snazi u Europskoj uniji od 17/08/2017.
English: It results in damage to blood vessels, causing fluid build up in the tissues of the stomach and bowel and affecting the blood supply of the brain, and can lead to death within 24 to 48 hours.
Croatian: Bolest ima za posljedicu oštećenje krvnih žila što uzrokuje nakupljanje tekućine u tkivima želuca i crijeva te utječe na dotok krvi u mozak i može dovesti do smrti unutar 24 do 48 sati.
English: Vepured contains verotoxin 2e that has been modified and inactivated so it can no longer cause disease.
Croatian: Vepured sadrži verotoksin 2e koji je modificiran i inaktiviran tako da više ne može prouzročiti bolest.
English: What are the risks associated with Vepured?
Croatian: Koji su rizici povezani s VMP-om Vepured?
English: This is a summary of the European public assessment report (EPAR) for Vepured.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) za veterinarsko-medicinski proizvod Vepured.
English: Vepured is given to piglets from 2 days of age as a single injection into the muscle in the neck.
Croatian: Vepured se daje dvodnevnoj prasadi kao jedna injekcija u područje vratnih mišića.
English: The most common side effects with Vepured (which may affect more than 1 in 10 animals) are mild inflammation at the injection site that resolves within 3 days of vaccination without treatment, mild depression on the day of vaccination and an increase in body temperature of maximum 1.1 °C which returns to normal within 1 day.
Croatian: Najčešće nuspojave VMP-a Vepured (mogu se javiti u više od 1 na 10 životinja) jesu blaga upala na mjestu primjene injekcije koja nestane bez liječenja u roku od 3 dana nakon cijepljenja, blaga depresija na dan cijepljenja i povećanje tjelesne temperature za najviše 1,1 °C što se vrati na normalnu vrijednost unutar 1 dana.
English: Vepured is a vaccine containing modified, inactivated verotoxin 2e.
Croatian: Vepured je cjepivo koje sadrži modificirani, inaktivirani verotoksin 2e.
English: A field study involving 2- to 3-day-old piglets, 1,173 of which were vaccinated with Vepured and 1,048 piglets given a dummy injection, showed that Vepured prevented death of virtually all the piglets from oedema disease over a 115 day period and there was a significant reduction in signs of the disease which included difficulty breathing, oedema (fluid retention) and signs related to the nervous system.
Croatian: Ispitivanje na terenu koje je uključivalo prasad staru 2 do 3 dana, od kojih je 1173 bilo cijepljeno VMP-om Vepured a 1048 prasadi primilo je lažnu injekciju, pokazalo je da je VMP Vepured spriječio uginuće gotovo sve prasadi od edemske bolesti tijekom razdoblja od 115 dana, a opaženo je i značajno smanjenje znakova bolesti kao što su otežano disanje, edem (nakupljanje tekućine) te znakovi povezani sa živčanim sustavom.
English: Oedema disease is caused by a bacterial toxin (poison) known as verotoxin 2e that is produced by certain strains of Escherichia coli.
Croatian: Edemsku bolest uzrokuje bakterijski toksin (otrov) poznat pod nazivom verotoksin 2e koji proizvode određeni sojevi bakterije Escherichia coli.
English: Vepured is available as a suspension for injection and can only be obtained with a prescription.
Croatian: Vepured je dostupan kao suspenzija za injekciju i izdaje se samo na veterinarski recept.
English: When Vepured is given to pigs, the animal's immune system recognises the toxin contained in the vaccine as ‘foreign' and makes antibodies against it.
Croatian: Kad se Vepured primijeni na svinje, imunosni sustav životinja prepozna toksin koji sadrži cjepivo kao strano tijelo i protiv njega proizvodi protutijela.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Vepured's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji odlučio je da koristi od VMP-a Vepured nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: E. coli verotoxoid vaccine (inactivated recombinant)
Croatian: Cjepivo protiv verotoksina iz E. coli (inaktivirano rekombinantno)
English: Vepured is a veterinary vaccine used to protect piglets against oedema disease (caused by verotoxin 2e produced by E. coli) and to reduce the loss of daily weight gain until slaughter.
Croatian: Vepured je veterinarsko cjepivo koje služi za zaštitu prasadi od edemske bolesti (prouzročene verotoksinom 2e iz bakterije E. coli ) te za smanjenje gubitka dnevnog prirasta težine do klanja.
English: How is Vepured used?
Croatian: Kako se Vepured koristi?
English: What benefits of Vepured have been shown in studies?
Croatian: Koje su koristi VMP-a Vepured utvrđene u ispitivanjima?
English: For practical information about using Vepured, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Praktične informacije o primjeni VMP-a Vepured vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: For more information about treatment with Vepured, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Dodatne informacije o terapiji VMP-om Vepured vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: How does Vepured work?
Croatian: Kako djeluje Vepured?
English: Vepured contains adjuvants (aluminium hydroxide and DEAE-dextran) to enhance the immune response.
Croatian: Kako bi se pojačao imunosni odgovor, Vepured sadrži pomoćne tvari (aluminijev hidroksid i DEAE-dekstran).
English: 196 (2 x 98) capsules (multipack)
Croatian: 196(2 x 98) kapsula (višestruko pakiranje)
English: Immediate Packaging
Croatian: Put primjene Unutarnje pakiranje Veličina pakiranja
English: ANNEX IV
Croatian: DODATAK IV
English: Conclusions presented by the European Medicines Agency on:
Croatian: Zaključci Europske agencije za lijekove o sljedećem:
English: The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the marketing authorisation under exceptional circumstances as further explained in the European Public Assessment Report.
Croatian: Nakon razmatranja zahtjeva, mišljenje je CHMP (Povjerenstvo za humane lijekove) da je omjer rizika i koristi povoljan te se može preporučiti izdavanje odobrenja za stavljanje gotovog lijeka u promet u iznimnim okolnostima, a što je dodatno objašnjeno u Europskom javnom izvješću o ocjeni lijeka.
English: • Marketing authorisation under exceptional circumstances
Croatian: • Odobrenje za stavljanje gotovog lijeka u promet u iznimnim okolnostima
English: CONCLUSIONS ON THE GRANTING OF THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES AND PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Croatian: ZAKLJUČCI EUROPSKE AGENCIJE ZA LIJEKOVE O IZDAVANJU ODOBRENJA
English: Number of continent days per week
Croatian: Broj kontinentnih dana tjedno
English: Adults (including elderly)
Croatian: Odrasli (uključujući starije bolesnike)
English: Treatment should be symptomatic and supportive.
Croatian: Liječenje treba biti simptomatsko i potporno.
English: A total of 33% of patients were ≥65 years of age and 11% were ≥75 years of age.
Croatian: Ukupno je 33% bolesnika bilo u dobi od ≥ 65 godina, a 11% u dobi od ≥ 75 godina.