FrancophonIA/ELRC3.0 huggingface dataset:
English: Contact the doctor if your child experiences tiredness, shortness of breath or swelling of ankles or legs - Inflammation of the pancreas (pancreatitis).
Croatian: Javite se liječniku ako Vaše dijete osjeća umor, nedostatak zraka ili mu otiču gležnjevi ili noge.
English: Hyperplasia in the gall bladder, hepatic biliary ducts, and pancreatic ducts were observed in subchronic and chronic toxicology studies.
Croatian: U ispitivanjima subkronične i kronične toksičnosti uočena je hiperplazija žučnog mjehura, jetrenih žučnih vodova i gušteračnih vodova.
English: After reconstitution, each vial contains 5 mg of teduglutide in 0.5 ml of solution, corresponding to a concentration of 10 mg/ml.
Croatian: Nakon pripreme otopine, svaka bočica sadrži 5 mg teduglutida u 0,5 ml otopine, što odgovara koncentraciji od 10 mg/ml.
English: Hepatic impairment
Croatian: Bolesti gušterače
English: - Do not inject Revestive into a vein (intravenously) or muscle (intramuscularly).
Croatian: - Ne primjenjujte Revestive u venu (intravenski) niti u mišić (intramuskularno).
English: For reconstitution
Croatian: Za potkožnu primjenu
English: Discontinuation of treatment
Croatian: NAČIN PRIMJENE LIJEKA
English: At Week 12, there was a -35.11% (±53.04) mean change from baseline in parenteral nutrition calorie consumption in the ITT population based on physician-prescribed data.
Croatian: Smanjenje unosa kalorija parenteralnom prehranom U 12. tjednu u populaciji predviđenoj za liječenje srednja vrijednost promjene u unosu kalorija parenteralnom prehranom u odnosu na početak iznosila je, na temelju podataka o parenteralnoj prehrani koju su propisali liječnici, -35,11% (±53,04).
English: Discard the vial and reconstitution needle together into the sharps disposal container.
Croatian: Bacite bočicu i iglu za pripremu zajedno u spremnik za oštre predmete.
English: Contact your doctor if you experience tiredness, shortness of breath or swelling of ankles or legs - Inflammation of the pancreas (pancreatitis).
Croatian: Javite se liječniku ako osjećate umor, nedostatak zraka ili Vam otiču gležnjevi ili noge.
English: Intravenous use vial (glass)
Croatian: Intravenska primjena Bočica (staklo)
English: Intravenous use
Croatian: Interavenska primjena
English: Subcutaneous use vial (glass)
Croatian: Bočica (staklo)
English: The full EPAR for Zoledronic acid medac can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Zoledronatna kiselina medac nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is available as a 4mg/100ml solution for infusion (drip into a vein) and as a 4mg/5ml concentrate for solution for infusion.
Croatian: Dostupan je kao otopina od 4mg/100ml za infuziju (drip u venu) i kao koncentrat od 4mg/5ml za otopinu za infuziju.
English: This means that Zoledronic acid medac is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zometa.
Croatian: To znači da je lijek Zoledronatna kiselina medac sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Zometa.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zoledronic acid medac.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i svoje preporuke za uporabu lijeka Zoledronatna kiselina medac.
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: Ovo uključuje frakture (lomove kosti), spinalnu kompresiju (u slučaju kada kost pritišće kralježničnu moždinu), poremećaji kosti koji zahtjevaju radioterapiju (terapiju zračenjem) ili kirurškim zahvatom, te hiperkalemija (visoke koncentracije kalcija u krvi).
English: The usual dose of Zoledronic acid medac is one infusion of 4 mg over at least 15 minutes.
Croatian: Uobičajena doza lijeka Zoledronatna kiselina medac je jedna infuzija od 4 mg tijekom najmanje 15 minuta.
English: Therefore, the CHMP's view was that, as for Zometa, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da kao i u pogledu lijeka Zometa koristi nadmašuju utvrđene rizike.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic acid medac on 03 August 2012.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Zoledronatna kiselina medac na snazi u Europskoj uniji od 3. kolovoza 2012.
English: For more information about treatment with Zoledronic acid medac, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Zoledronatna kiselina medac pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: In addition, the company that markets Zoledronic acid medac will provide a card to inform patients about the risk of osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth) and to instruct them to contact their doctor if they experience symptoms.
Croatian: Nadalje, proizvođač lijeka Zoledronatna kiselina medac bolesnicima će dostaviti karticu s informacijama o riziku osteonekroze čeljusti (oštećenje kosti čeljusti, koje može rezultirati s boli, bolnim ustima ili gubljenjem zubi) i uputama da se obrate svom liječniku ako iskuse takve simptome
English: Because Zoledronic acid medac is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Zoledronatna kiselina medac generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: This is a summary of the European public assessment report (EPAR) for Zoledronic acid medac.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Zoledronatna kiselina medac.
English: No additional studies were needed as Zoledronic acid medac is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Zometa.
Croatian: Nisu bila potrebna dodatna ispitivanja jer je Zoledronatna kiselina medac generički lijek koji se daje infuzijom ili intravenoznom injekcijom te sadrži istu djelatnu tvar kao i referentni lijek Zometa.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zoledronic acid medac, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi za lijek Zoledronatna kiselina medac nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Zoledronic acid medac must only be used by a doctor who has experience in the use of this type of medicine given into a vein.
Croatian: Zoledronatnu kiselinu medac smije primjenjivati samo liječnik koji ima iskustva u primjeni ovog tipa lijeka koji se primjenjuje u venu
English: Zoledronic acid medac can also be used to treat the hypercalcaemia caused by tumours.
Croatian: Zoledronatna kiselina medac se može također koristiti za liječenje hiperkalemije koju uzrokuju tumori.
English: What measures are being taken to ensure the safe and effective use of Zoledronic acid medac?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Zoledronatna kiselina medac?
English: The company provided data from the published literature on zoledronic acid.
Croatian: Tvrtka je dostavila podatke o zoledronatnoj kiselini iz objavljenje literature.
English: The CHMP concluded that, in accordance with EU requirements, Zoledronic acid medac has been shown to have comparable quality and to be bioequivalent to Zometa.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je da je u skladu sa zahtjevima EU-a potvrđeno kako lijek Zoledronatna kiselina medac posjeduje usporedivu kvalitetu te je bioekvivalentan s lijekom Zometa.
English: A risk management plan has been developed to ensure that Zoledronic acid medac is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Zoledronatna kiselina medac.
English: Zoledronic acid medac is a ‘generic medicine'.
Croatian: Zoledronatna kiselina medac je „generički lijek”.
English: Zoledronic acid medac zoledronic acid
Croatian: Zoledronatna kiselina medac zoledronatna kiselina
English: Zoledronic acid medac can be used to prevent bone complications in adults with advanced cancer that is affecting the bone.
Croatian: Zoledronatna kiselina medac koristiti za sprječavanje koštanih komplikacija u odraslih osoba s uznapredovalim rakom kostiju koji zahvaća kost.
English: The Committee recommended that Zoledronic acid medac be given marketing authorisation.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Zoledronatna kiselina medac.
English: What are the benefits and risks of Zoledronic acid medac?
Croatian: Koje su koristi i rizici od lijeka Zoledronatna kiselina medac?
English: The active substance in Zoledronic acid medac, zoledronic acid, is a bisphosphonate.
Croatian: Djelatna tvar u lijeku Zoledronatna kiselina medac, zoledronatna kiselina, je bisfosfonat.
English: Other information about Zoledronic acid medac
Croatian: Ostale informacije o lijeku Zoledronatna kiselina medac
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 moderate problems with their kidneys.
Croatian: Ako se koristi za sprječavanje komplikacija kosti, infuzija se može ponoviti svaka tri do četiri tjedna, a bolesnik treba također uzimati dodatke kalcija i vitamina D.
English: Zoledronic acid medac is a medicine that contains the active substance zoledronic acid.
Croatian: Zoledronatna kiselina medac je lijek koji sadrži zoledronatnu kiselinu kao djelatnu tvar.
English: Why has Zoledronic acid medac been approved?
Croatian: Zašto je lijek Zoledronatna kiselina medac odobren?
English: By preventing the breakdown of bones, Zoledronic acid medac also helps to reduce the amount of calcium released into the blood.
Croatian: Zoledronatna kiselina medac također doprinosi snižavanju količine kalcija koja se oslobađa u krv time što sprječava razgradnju kostiju.
English: What is Zoledronic acid medac?
Croatian: Što je Zoledronatna kiselina medac?
English: What is Zoledronic acid medac used for?
Croatian: Za što se Zoledronatna kiselina medac koristi?
English: How does Zoledronic acid medac work?
Croatian: Kako djeluje Zoledronatna kiselina medac?
English: How is Zoledronic acid medac used?
Croatian: Kako se koristi Zoledronatna kiselina medac?
English: How has Zoledronic acid medac been studied?
Croatian: Kako je lijek Zoledronatna kiselina medac ispitivan?
English: It is taken once a day, consistently either in the morning or in the evening.
Croatian: Uzima se jednom dnevno, dosljedno ili ujutro ili uvečer.
English: Further information on Sprycel can be found on the Agency's website ema.europa.eu/medicines/human/EPAR/Sprycel.
Croatian: Više informacija o lijeku Sprycel nalazi se na internetskim stranicama Agencije ema.europa.eu/medicines/human/EPAR/Sprycel.
English: The dose is then gradually increased until the disease is controlled well enough.
Croatian: Doza se zatim postupno povećava sve dok bolest ne bude pod dostatnom kontrolom.
English: Sprycel is also used in children to treat:
Croatian: Sprycel se također primjenjuje za liječenje djece:
English: Such events were: any sign of the disease in bone marrow, return of the disease anywhere in the body, a second cancer or death.
Croatian: Ti su događaji sljedeći: bilo kakav znak bolesti koštane srži, povratak bolesti bilo gdje u tijelu, drugi rak ili smrt.
English: What measures are being taken to ensure the safe and effective use of Sprycel?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Sprycel?
English: The doses for Sprycel tablets and suspension are not the same.
Croatian: Doze za tablete Sprycel i za suspenziju nisu jednake.
English: The main measure of effectiveness was the proportion of patients who did not have an unwanted event within 3 years of treatment.
Croatian: Glavna mjera učinkovitosti bio je udio bolesnika kod kojih se nije pojavio neželjen događaj u roku od 3 godine nakon liječenja.
English: The starting dose depends on the condition being treated and, for children, their body weight.
Croatian: Početna doza ovisi o stanju koje se liječi, a kod djece o njihovoj tjelesnoj težini.
English: Sprycel is available as tablets (20, 50, 70, 80, 100 and 140 mg) and a powder to make up a suspension (10 mg/ml) to be taken by mouth.
Croatian: Sprycel je dostupan u obliku tableta (20, 50, 70, 80, 100 i 140 mg) i kao prašak za suspenziju (10 mg/ml) koja se uzima na usta.
English: Other information about Sprycel
Croatian: Ostale informacije o lijeku Sprycel
English: Among patients treated with Sprycel and chemotherapy, 66% did not have an unwanted event.
Croatian: Među bolesnicima koji su primali lijek Sprycel i kemoterapiju, 66 % njih nije imalo neželjen događaj.
English: What are the risks associated with Sprycel?
Croatian: Koji su rizici povezani s lijekom Sprycel?
English: The most common side effects with Sprycel (seen in more than 1 patient in 10) are infection, suppression of the bone marrow (decreasing numbers of blood cells), headache, haemorrhage (bleeding), pleural effusion (fluid around the lungs), dyspnoea (difficulty breathing), diarrhoea, vomiting, nausea (feeling sick), abdominal pain (belly ache), skin rash, musculoskeletal pain, tiredness, swelling in the legs and arms and in the face, fever.
Croatian: Najčešće nuspojave lijeka Sprycel (zabilježene u više od 1 na 10 osoba) jesu infekcija, supresija koštane srži (smanjenje broja krvnih stanica), glavobolja, hemoragija (krvarenje), pleuralni izljev (tekućina oko pluća), dispneja (poteškoće s disanjem), proljev, povraćanje, mučnina, bol u abdomenu (trbuhu), kožni osip, mišićno-koštani bol, umor, oticanje udova i lica, vrućica.
English: Side effects reported with Sprycel are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Sprycel pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: What is Sprycel and what is it used for?
Croatian: Što je Sprycel i za što se primjenjuje?
English: By blocking Bcr-Abl kinase, as well as other kinases, Sprycel helps to reduce the number of leukaemia cells.
Croatian: Blokiranjem Bcr-Abl kinaze, kao i drugih kinaza, Sprycel pomaže u smanjenju broja leukemijskih stanica.
English: This enzyme is produced by leukaemia cells, and causes them to multiply uncontrollably.
Croatian: Taj enzim proizvode leukemijske stanice te on uzrokuje njihovo nekontrolirano množenje.
English: In addition, the number of white blood cells containing the Philadelphia chromosome was reduced in around 33 to 66% of treated patients in the five main studies.
Croatian: Nadalje, broj leukocita koji su sadržavali Philadelphia kromosom smanjio se za od oko 33 do 66 % liječenih bolesnika u pet glavnih ispitivanja.
English: • CML in ‘chronic', ‘accelerated' and ‘blast' phases.
Croatian: • KML-om u „kroničnoj”, „ubrzanoj” i „blastičnoj” fazi.
English: Sprycel received a marketing authorisation valid throughout the European Union on 20 November
Croatian: Lijek Sprycel dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 20. studenoga
English: The European Medicines Agency decided that Sprycel'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 lijeka Sprycel nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sprycel have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Sprycel nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Treatment is stopped if the medicine no longer controls the condition or if the patient cannot take the medicine because of side effects.
Croatian: Liječenje se trajno prekida ako se lijekom više ne može kontrolirati stanje ili ako bolesnik ne može uzimati lijek zbog nuspojava.
English: Sprycel was more effective than imatinib: within one year, 77% of patients receiving Sprycel no longer had the Philadelphia chromosome in their blood cells, compared with 66% of patients receiving imatinib.
Croatian: Lijek Sprycel bio je učinkovitiji od imatiniba: u roku od jedne godine 77 % bolesnika koji su primali lijek Sprycel nisu više imali Philadelphia kromosom u krvnim stanicama u usporedbi sa 66 % bolesnika koji su primali imatinib.
English: None of these studies compared Sprycel with another medicine.
Croatian: Ni u jednom od tih ispitivanja lijek Sprycel nije se usporedio s nekim drugim lijekom.
English: Sprycel can only be obtained with a prescription and treatment should be started by a doctor who has experience in the diagnosis and treatment of leukaemia.
Croatian: Sprycel se izdaje samo na liječnički recept, a liječenje mora započeti liječnik s iskustvom u dijagnosticiranju i liječenju leukemije.
English: Why is Sprycel authorised in the EU?
Croatian: Zašto je lijek Sprycel odobren u EU-u?
English: The doctor may reduce the dose or interrupt treatment if blood cell counts are too low or certain side effects occur.
Croatian: Liječnik može smanjiti dozu ili privremeno prekinuti liječenje ako je broj krvnih stanica prenizak ili ako se pojave određene nuspojave.
English: In children with ALL who are also receiving other cancer medicines, a fixed dose of Sprycel is used throughout their treatment.
Croatian: U djece s ALL-om koja primaju i druge lijekove protiv raka primjenjuje se fiksna doza lijeka Sprycel tijekom cijelog vremena njihova liječenja.
English: Dasatinib acts mainly by blocking the Bcr-Abl protein kinase.
Croatian: Dasatinib većinom djeluje tako da blokira Bcr-Abl protein-kinaze.
English: An overview of Sprycel and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Sprycel i zašto je odobren u EU-u
English: Once- and twice-daily Sprycel had similar effectiveness, but the once-daily dose caused fewer side effects.
Croatian: Sprycel primijenjen jednom ili dvaput dnevno imao je sličnu učinkovitost, no doza primijenjena jednom dnevno uzrokovala je manje nuspojava.
English: • chronic myeloid leukaemia (CML) in the ‘chronic' phase in newly diagnosed patients who are ‘Philadelphia chromosome positive' (Ph+).
Croatian: • kroničnom mijeloičnom leukemijom (KML) u „kroničnoj” fazi u bolesnika s novodijagnosticiranom bolesti koji su „pozitivni na Philadelphia kromosom” (Ph+).
English: • newly diagnosed Ph+ ALL in combination with chemotherapy (cancer medicines).
Croatian: • s novodijagnosticiranim Ph+ ALL-om u kombinaciji s kemoterapijom (lijekovi protiv raka).
English: Ph+ means that some of the patient's genes have rearranged themselves to form a special chromosome called the Philadelphia chromosome which produces an enzyme, Bcr-Abl kinase that leads to the development of leukaemia.
Croatian: Ph+ znači da su se neki od bolesnikovih gena prerasporedili i stvorili poseban kromosom zvan Philadelphia kromosom koji proizvodi enzim, BcrAbl kinazu, koji uzrokuje razvoj leukemije;
English: Most of these studies assessed how well the leukaemia responded to treatment by measuring the levels of white cells and platelets in the blood, to see if they were returning to within normal levels, and by measuring the number of white blood cells that contained the Philadelphia chromosome, to see if it was decreasing.
Croatian: U većini tih ispitivanja procjenjivalo se koliko je dobro leukemija odgovorila na liječenje tako što se mjerila razina leukocita i trombocita u krvi kako bi se vidjelo vraćaju li se na normalne vrijednosti te broj leukocita koji su sadržavali Philadelphia kromosom kako bi se vidjelo smanjuje li se.
English: As for all medicines, data on the use of Sprycel are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Sprycel kontinuirano se prate.
English: In patients with CML in other phases (accelerated, myeloid blast and lymphoid blast) and in ALL, around 25 to 33% of the patients had complete response.
Croatian: U bolesnika s KML-om u drugim fazama (ubrzana, mijeloblastična i limfoblastična) te u bolesnika s ALL-om, za od oko 25 do 33 % njih odgovor je bio potpun.
English: The active substance in Sprycel, dasatinib, belongs to a group of medicines that block enzymes known as protein kinases.
Croatian: Djelatna tvar u lijeku Sprycel, dasatinib, pripada skupini lijekova koji inhibiraju enzime pod nazivom protein-kinaze.
English: In comparison, using results of previous studies, the figure was 49% in patients who had received chemotherapy alone and 59% in patients who had received imatinib and chemotherapy.
Croatian: Za usporedbu, rezultati prethodnih ispitivanja upućuju na to da je ta brojka iznosila 49 % u bolesnika koji su primali samo kemoterapiju te 59 % u bolesnika koji su primali imatinib i kemoterapiju.
English: In a study involving 106 children and adolescents with newly diagnosed Ph+ ALL, patients were treated with Sprycel and chemotherapy.
Croatian: U ispitivanju kojim je bilo obuhvaćeno 106 djece i adolescenata s novodijagnosticiranim Ph+ ALL-om, bolesnici su liječeni lijekom Sprycel i kemoterapijom.
English: For more information about using Sprycel, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Sprycel pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Sprycel is used when other treatments including imatinib (another cancer medicine) do not work or cause troublesome side effects;
Croatian: Sprycel se primjenjuje kada druga liječenja, uključujući imatinibom (drugim lijekom protiv raka), ne djeluju ili uzrokuju ozbiljne nuspojave;
English: The five main studies of Sprycel in adults involved 515 patients, all of whom had received treatment with imatinib, which had not worked or had stopped working.
Croatian: U pet glavnih ispitivanja lijeka Sprycel u odraslih osoba bilo je uključeno 515 bolesnika koji su svi prethodno primali liječenje imatinibom koje nije djelovalo ili je prestalo djelovati.
English: • Ph+ acute lymphoblastic leukaemia (ALL), where lymphocytes (another type of white blood cell) multiply too quickly, or in ‘lymphoid blast' CML.
Croatian: • Ph+ akutnom limfoblastičnom leukemijom (ALL) u kojoj se limfociti (druga vrsta bijelih krvnih stanica) prebrzo množe ili limfoblastičnim KML-om.
English: In CML, granulocytes (a type of white blood cell) start growing out of control.
Croatian: U oboljelih od KML-a granulociti (vrsta bijelih krvnih stanica) počinju nekontrolirano rasti.
English: Sprycel is a cancer medicine.
Croatian: Sprycel je lijek protiv raka.