FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be examined regularly for the presence of: peripheral oedema, leg discolouration, digital clubbing, weak/irregular pulse(s), tachycardia, cardiac murmur, vascular bruits, raised jugular vein pressure, lung basal crepitations, pleural/pericardial friction rubs, abdominal/flank masses/tenderness.
Croatian: Bolesnike treba redovito pregledavati za prisutnost znakova: perifernog edema, promjene boje nogu, batićaste prste, slab/nepravilan puls(eve), tahikardiju, šum na srcu, vaskularne šumove, povišen tlak u jugularnoj veni, bazalne krepitacije u plućima, zvuk pleuralnog/perikardijalnog trenja, mase/osjetljivost u području abdomena/slabina.
English: Cardiac and vascular disorders
Croatian: Srčani i krvožilni poremećaji
English: A treatment-free interval of at least 4 weeks must be allowed between courses.
Croatian: Između terapija mora postojati razmak od najmanje 4 tjedna bez uzimanja lijeka.
English: Pleuro-pulmonary fibrosis presents as precordial pains, dyspnoea, pleural frictional noise, lung basal crepitations or pleural effusion, digital clubbing, dry cough, anorexia and weight loss.
Croatian: Pleuro-pulmonalna fibroza se manifestira kao prekordijalne boli, dispneja, šum pleuralnog trenja, bazalne krepitacije u plućima ili pleuralni izljev, batićasti prsti, suhi kašalj, anoreksija i gubitak težine.
English: During clinical assessment of the patient, particular attention should be paid to complaints of: abdominal, loin or chest pain, palpitations, dyspnoea, dry cough, nausea, malaise, fatigue, anorexia/weight loss, urinary symptoms, pain/coldness/numbness in limbs.
Croatian: Tijekom kliničke procjene bolesnika osobitu pažnju treba posvetiti ukoliko se tuži na: bol u abdomenu, slabinama ili prsnom košu, palpitacije, dispneju, suhi kašalj, mučninu, malaksalost, umor, anoreksiju/gubitak težine, urinarne simptome, bol/hladnoću/utrnulost udova.
English: Take special care with [Invented name]
Croatian: [Zaštićeno ime]
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.> <Or> <[Invented name] contains lactose and sucrose.
Croatian: Bolesnici s rijetkim nasljednim poremećajima nepodnošenja galaktoze, deficijencijom laktaze ili malapsorpcijom glukoze-galaktoze ne smiju uzimati ovaj lijek.> <Ili> <[Zaštićeno ime] sadrži laktozu i saharozu.
English: However, it should only be used after other standard treatments have failed, those treatments should have been tried for at least 4 months at the maximum dose without success before [Invented name] is started.
Croatian: Ta su se liječenja morala koristiti tijekom najmanje 4 mjeseca u najvećoj dozi bez uspjeha prije nego se počne uzimati [Zaštićeno ime].
English: Fibrosis of the retroperitoneum can cause symtpoms such general discomfort, back pain, waist- or rib pain, pain during urination, reduced urine production, loss of appetite and skin discolouration in the legs.
Croatian: Fibroza retroperitoneuma može uzrokovati simptome kao što su opća nelagoda, bol u leđima, struku ili rebrima, bol tijekom mokrenja, smanjeno stvaranje mokraće, gubitak apetita i promjene boje kože na nogama.
English: Pleuro-pulmonary fibrosis (see General disorders), difficulty of breath, pleura inflammation, presence of fluid in the pleura.
Croatian: Pleuropulmonalna fibroza (pogledajte pod Opći poremećaji), teškoće disanja, upala pleure (poplućnice), tekućina između dva sloja pleure.
English: Retroperitoneal Fibrosis may occur.
Croatian: Može se javiti retroperitonealna fibroza.
English: Patients with rare hereditary problems of galactose or fructose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption or sucraseisomaltase insufficiency should not take this medicine.>
Croatian: Bolesnici s rijetkim nasljednim poremećajima nepodnošenja galaktoze ili fruktoze, deficijencijom laktaze ili malapsorpcijom glukoze-galaktoze ili nedostatkom saharaze-izomaltaze ne smiju uzimati ovaj lijek.>
English: The duration of continuous administration must not exceed six months.
Croatian: Trajanje neprekidnog uzimanja ne smije prelaziti šest mjeseci.
English: (see section 4.4 regarding the need for specialist monitoring requirements)
Croatian: Dio 4.4 Posebna upozorenja i mjere opreza pri uporabi
English: Section 4.1 Therapeutic indications [The wording of this section should be read as below]
Croatian: Dio 4.1 Terapijske indikacije
English: <Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take [Invented name].>
Croatian: <Bolesnici s rijetkim nasljednim poremećajima nepodnošenja galaktoze, nedostatkom laktaze ili malapsorpcijom glukoze-galaktoze ne smiju uzimati [Zaštićeno ime].>
English: <Patients with rare hereditary problems of galactose or fructose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take [Invented name].>
Croatian: <Bolesnici s rijetkim nasljednim poremećajima nepodnošenja galaktoze ili fruktoze, nedostatkom laktaze ili malapsorpcijom glukoze-galaktoze ili nedostatkom saharaze-izomaltaze ne smiju uzimati [Zaštićeno ime].>
English: Section 4.2 Posology and method of administration [This section should be amended to reflect the following wording]
Croatian: Dio 4.2 Doziranje i način primjene
English: 6 August 2014
Croatian: 06. kolovoza 2014.
English: The European Commission issued a decision on 6 August 2014.
Croatian: Europska komisija usvojila je odluku dana 6. kolovoza 2014.
English: • treatment of schizophrenia;
Croatian: • liječenje shizofrenije;
English: Consequently, newborns should be monitored carefully.
Croatian: Slijedom navedenog, novorođenčad treba pažljivo pratiti.
English: 4.6 Fertility, pregnancy and lactation
Croatian: 4.6 Plodnost, trudnoća i laktacija
English: Therefore, quetiapine should only be used during pregnancy if the benefits justify the potential risks.
Croatian: Stoga, kvetiapin se treba koristiti samo tijekom trudnoće, ako koristi opravdavaju potencijalne rizike.
English: Seroquel is available as tablets (25, 100, 150, 200 and 300 mg) while Seroquel XR is available as prolonged-release tablets (50, 150, 200, 300 and 400 mg).
Croatian: Seroquel je dostupan kao tablete (25, 100, 150, 200 i 300 mg) dok je Seroquel XR dostupan kao tablete s produljenim otpuštanjem (50, 150, 200, 300 i 400 mg).
English: The CHMP also harmonised other sections of the SmPC including sections 4.4 (special warnings and precautions for use) and 4.8 (undesirable effects).
Croatian: CHMP je također uskladio i druga poglavlja SPC-a uključujući poglavlje 4.4 (posebna upozorenja i mjere opreza) i 4.8 (neželjene nuspojave).
English: The CHMP also harmonised the dosing recommendations, particularly how to increase the dose and the recommended daily dose.
Croatian: CHMP je također uskladio preporuke za doziranje, posebice način na koji se povećava doza i preporučena dnevna doza.
English: EMA/301727/2014 Rev. 1 EMEA/H/A-30/1362
Croatian: 1 EMEA/H/A-30/1362
English: Prolonged-release means that the active substance is released slowly from the tablet over a few hours.
Croatian: Produljeno otpuštanje znači da se djelatna tvar otpušta polako iz tablete tijekom nekoliko sati.
English: The exact mechanism of action of quetiapine is unknown, but it attaches to several receptors on the surface of nerve cells in the brain, including the receptors for the neurotransmitters dopamine and serotonin.
Croatian: Točan mehanizam djelovanja kvetiapin nije poznat, no vezuje se na nekoliko receptora na površini živčanih stanica u mozgu, uključujući receptore za neurotransmitere dopamina i serotonina.
English: As neurotransmitters are chemicals that allow nerve cells to communicate with each other, this affects signals transmitted between brain cells.
Croatian: Budući da su neurotransmiteri kemikalije koje omogućuju živčanim stanicama međusobnu komunikaciju, ovo djeluje na signale koji se odašilju između moždanih stanica.
English: Since these neurotransmitters are involved in schizophrenia, bipolar disorder and major depression, quetiapine helps to normalise the activity of the brain, reducing the symptoms of these diseases.
Croatian: Budući da su ovi neurotransmiteri uključeni u shizofreniju, bipolaran poremećaj i veliku depresiju, kvetiapin pomaže pri normalizaciji aktivnosti mozga, smanjujući simptome ovih bolesti.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for these medicines in the European Union (EU).
Croatian: Odbor za lijekove za rijetke bolesti za lijek (CHMP) pri Agenciji zaključio je da postoji potreba za usklađivanjem informacija za propisivanje ovih lijekova unutar Europske unije (EU).
English: Having reviewed the data available on the use of quetiapine during pregnancy, the CHMP concluded that no definite conclusion can be drawn on the risk of malformations in the unborn child when the medicine is used during early pregnancy (first trimester).
Croatian: Nakon pregleda dostupnih podataka o primjeni kvetiapina tijekom trudnoće, CHMP je zaključio da se ne može donijeti konačan zaključak o riziku od malformacija u nerođene djece ako se lijek koristi tijekom rane trudnoće (prvo tromjesečje).
English: They are used in patients with schizophrenia, a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Croatian: Koriste se u bolesnika oboljelih od shizofrenije, mentalne bolesti s nizom simptoma, uključujući neorganizirano razmišljanje i govor, halucinacije (bolesnici čuju ili vide nešto čega nema), sumnje i iluzije (pogrešna vjerovanja).
English: After reviewing the available data supporting the use of the medicines, the CHMP agreed that Seroquel and Seroquel XR can continue to be used for the treatment of schizophrenia and treatment and prevention of bipolar disorder, but recommended harmonised wordings for these indications as follows:
Croatian: Nakon pregleda dostupnih podataka koji podržavaju primjenu lijekova, CHMP je bio suglasan da se Seroquel i Seroquel XR mogu nastaviti koristiti za liječenje shizofrenije te liječenje i prevenciju bipolarnog poremećaja, no preporučio je usklađivanje ovih indikacija kako slijedi:
English: Additionally, the data available show that newborns who were exposed to antipsychotics (including quetiapine) during late pregnancy (third trimester) are at risk of side effects including agitation, somnolence, breathing and feeding problems.
Croatian: Nadalje, dostupni podaci pokazuju da je novorođenčad koja je izložena antipsihoticima (uključujući kvetiapin) tijekom kasne trudnoće (treće tromjesečje) izložena riziku od nuspojava uključujući razdražljivost, somnolenciju, disanje i probleme sa hranjenjem.
English: This has led to divergences across Member States in the way the medicines can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicines are marketed.
Croatian: Ovo je rezultiralo razlikama u primjeni lijekova diljem država članica, što se očituje u razlikama u sažetcima opisa svojstava lijeka (SmPCs), etiketi i uputama za primjenu lijeka u državama u kojima je lijek u prometu.
English: Seroquel XR can also be used as add-on treatment in major depression.
Croatian: Seroquel XR se može također koristiti kao dodatno liječenje u slučaju velike depresije.
English: Seroquel XR can also continue to be used as add-on to ongoing treatment for major depressive episodes in patients with major depressive disorder who have had sub-optimal response to treatment with other antidepressants.
Croatian: Seroquel XR se može nastaviti koristiti kao dodatak aktualnom liječenju za većinu depresivnih epizoda u bolesnika s većim depresivnim poremećajem koji su imali suboptimalan odgovor na liječenje drugim antidepresivima.
English: They are also used for the prevention and treatment of bipolar disorder, a mental illness in which patients have manic episodes (periods of abnormally high mood), alternating with periods of normal mood, as well as episodes of depression.
Croatian: Koriste se i za prevenciju te liječenje bipolarnog poremećaja, mentalna bolest u slučaju koje bolesnici imaju manične epizode (razdoblja abnormalno dobrog raspoloženja), koja se izmjenjuju s razdobljima normalnog raspoloženja kao i epizodama depresije.
English: Questions and answers on Seroquel, Seroquel XR and associated names (quetiapine)
Croatian: Pitanja i odgovori o lijekovima Seroquel, Seroquel XR i povezanim nazivima (kvetiapin)
English: • treatment of moderate to severe manic episodes in bipolar disorder and major depressive episodes in bipolar disorder;
Croatian: • liječenje umjerenih do ozbiljnih maničnih epizoda u slučaju bipolarnog poremećaja i većih depresivnih epizoda u slučaju bipolarnog poremećaja;
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Croatian: Na temelju dostavljenih podataka i znanstvene rasprave unutar Odbora, mišljenje je CHMP-a da se SPC-ovi, etikete i upute o lijeku trebaju uskladiti diljem EU-a.
English: On 22 May 2014, the European Medicines Agency completed a review of Seroquel and Seroquel XR.
Croatian: Dana 22. svibnja 2014., Europska agencija za lijekove završila je pregled lijeka Seroquel i Seroquel XR.
English: Seroquel and Seroquel XR are authorised in the EU via national procedures.
Croatian: Seroquel i Seroquel XR su odobreni u EU putem nacionalnih postupaka.
English: On 12 June 2013, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Seroquel and Seroquel XR in the EU.
Croatian: Dana 12. lipnja 2013., Europska komisija uputila je predmet CHMP-u kako bi se uskladila odobrenja za stavljanje lijekova u promet za Seroquel i Seroquel XR na području EU.
English: • prevention of recurrence of manic or depressed episodes in patients with bipolar disorder who previously responded to quetiapine treatment.
Croatian: • prevencija nastupanja maničnih ili depresivnih epizoda u bolesnika s bipolarnim poremećajem koji su već odgovorili na terapiju kvetiapinom.
English: What are Seroquel and Seroquel XR?
Croatian: Što su Seroquel i Seroquel XR?
English: The company that markets these medicines is Astra Zeneca.
Croatian: Astra Zeneca je tvrtka koja stavlja ove lijekove u promet.
English: Why were Seroquel and Seroquel XR reviewed?
Croatian: Zašto su Seroquel i Seroquel XR pregledani?
English: Seroquel and Seroquel XR are antipsychotic medicines that contain the active substance quetiapine.
Croatian: Seroquel i Seroquel XR su antipsihotici koji sadrže djelatnu tvar kvetiapin.
English: Seroquel and Seroquel XR are also marketed under other trade names.
Croatian: Seroquel i Seroquel XR stavljaju se u promet i pod drugim trgovačkim nazivima.
English: Seroquel and Seroquel XR were identified by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) as needing harmonisation.
Croatian: Koordinacijska grupa za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove utvrdila je potrebu za usklađivanjem u slučaju lijekova Seroquel i Seroquel XR.
English: EMA/206629/2016 EMEA/H/C/000609
Croatian: EU/1/05/314/001
English: The medicine can only be obtained with a prescription.
Croatian: Lijek se izdaje na recept.
English: The use of Kepivance should be supervised by a doctor who has experience in anticancer therapy.
Croatian: Liječenje Kepivanceom treba nadzirati liječnik s iskustvom u primjeni onkološkog liječenja.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Kepivance on 25 October 2005.
Croatian: Datum prvog odobrenja: 25. listopada 2005.
English: Three doses are given on three consecutive days before myeloablative therapy, finishing 24 to 48 hours before the therapy.
Croatian: Prve 3 doze treba primijeniti prije mijeloablativnog liječenja, tako da se 3. doza primijeni 24 do 48 sati prije mijeloablativne radiokemoterapije.
English: How does Kepivance work?
Croatian: Kako primjenjivati Kepivance
English: Other information about Kepivance:
Croatian: Nemojte primjenjivati Kepivance:
English: Patients receiving Kepivance also reported less mouth and throat soreness with improved swallowing, drinking, eating and talking.
Croatian: U ovom kliničkom ispitivanju faze 3 bolesnici liječeni paliferminom prijavili su značajno poboljšanje po pitanju nadraženosti usne šupljine i grla i njenog utjecaja na gutanje, pijenje, jedenje i pričanje.
English: It is given as an injection into a vein for a total of six doses.
Croatian: ukupno 6 doza.
English: Kepivance stimulates the growth of the epithelial cells, helping to reduce the incidence, severity and duration of oral mucositis in cancer patients undergoing intensive therapy.
Croatian: Kepivance se koristi za smanjenje učestalosti, trajanja i težine simptoma oralnog mukozitisa.
English: It contains the active substance
Croatian: OTPADNIH MATERIJALA KOJI POTJEČU
English: Kepivance is a powder that is made up into a solution for injection.
Croatian: Kepivance je bijeli prašak koji se isporučuje u bočicama.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Croatian: 5550 Airport Boulevard Boulder, Colorado 80301
English: Palifermin is very similar to a natural growth factor found in the body called keratinocyte growth factor (KGF).
Croatian: Palifermin je humani čimbenik rasta keratinocita (od engl.
English: This summary was last updated in 03-2016.
Croatian: Datum posljednje obnove odobrenja: 23. rujna 2010.
English: Kepivance should not be used in people who may be hypersensitive (allergic) to palifermin, proteins produced by Escherichia coli (a bacterium) or any of the other ingredients.
Croatian: - ako ste alergični na palifermin, proteine dobivene iz Escherichie coli ili druge sastojke ovog lijeka (navedene u dijelu 6).
English: In the main study, the patients receiving chemotherapy and radiotherapy had severe oral mucositis for a shorter time if they received Kepivance (3.7 days, on average) than if they received placebo (10.4 days, on average).
Croatian: Osim toga, incidencija infekcija bila je veća u bolesnika koji su palifermin primili prije i poslije kemoterapije (49,5%) u usporedbi s bolesnicima koji su primali placebo (24,6%).
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
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Kepivance is used in adults who are likely to develop severe mucositis because they have blood cancer, and are being treated with myeloablative chemotherapy (medicines to destroy the bone marrow) in combination with radiotherapy (treatment with radiation) and an autologous haematopoietic stem-cell transplant (a transplant of their own blood-producing cells).
Croatian: Kepivance je indiciran za smanjenje incidencije, trajanja i težine oralnog mukozitisa u odraslih bolesnika s hematološkim malignim bolestima koji primaju mijeloablativnu radiokemoterapiju povezanu s visokom stopom incidencije teškog mukozitisa i kojima je potrebna terapija autolognim krvotvornim matičnim stanicama.
English: For more information about treatment with Kepivance, read the package leaflet (also part of the EPAR).
Croatian: Za informacije o pripremi i primjeni Kepivancea pročitajte informacije za zdravstvene djelatnike na kraju ove upute.
English: However, in the study of patients receiving chemotherapy without radiation, there was no difference in the severity of mucositis between the patients receiving placebo and those receiving either schedule of Kepivance.
Croatian: Hematopoetski oporavak nakon infuzije progenitornih stanica iz periferne krvi bio je sličan u bolesnika koji su primili Kepivance i onih koji su primili placebo te nisu ustanovljene razlike u napredovanju bolesti ili preživljenju.
English: At the request of the CHMP, the company carried out a further study comparing two schedules of Kepivance with placebo.
Croatian: U niti jednom od dva protokola doziranja nisu utvrđeni statistički značajni rezultati u usporedbi s placebom.
English: What is the risk associated with Kepivance?
Croatian: Moguće nuspojave Kako čuvati Kepivance
English: Palifermin is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce palifermin.
Croatian: Kepivance sadrži djelatnu tvar palifermin, protein proizveden biotehnologijom u bakteriji
English: For the full list of all side effects reported with Kepivance, see the package leaflet.
Croatian: Za cjeloviti popis pomoćnih tvari, vidjeti dio 6.1.
English: The study involved 281 adults who were receiving chemotherapy to treat multiple myeloma (a type of blood cancer), but without any radiotherapy.
Croatian: U sklopu ispitivanja (n = 281) bolesnici s multiplim mijelomom kondicionirani su melfalanom
English: The replacement palifermin acts in the same way as naturally produced KGF.
Croatian: Palifermin djeluje na isti način kao i čimbenik rasta keratinocita koji Vaše tijelo prirodno stvara u malim količinama.
English: Epithelial cells in the mouth are normally replaced by the body every few days.
Croatian: Uobičajena doza Kepivancea je 60 mikrograma po kilogramu tjelesne težine dnevno.
English: The most common side effects with Kepivance (seen in more than 1 patient in 10) are dysgeusia (taste disturbances), increased levels of lipase and amylase (enzymes used in digestion), hypertrophy (increase in the number or size of cells) or discoloration of the mouth and tongue, rash, pruritus (itching), erythema (redness), arthralgia (joint pain), oedema (swelling), pain and pyrexia (fever).
Croatian: U ispitivanjima toksičnosti za razvoj embrija/fetusa provedenim na štakorima i kunićima pri dozama od 500 mikrograma/kg/dan za štakore i 150 mikrograma/kg/dan za kuniće liječenje paliferminom bilo je povezano s razvojnom toksičnošću (povećani postimplantacijski mortalitet, smanjena veličina legla i/ili smanjena težina fetusa).
English: The active substance in Kepivance, palifermin, is a growth factor that stimulates the ‘epithelial' cells that line the mouth and gastrointestinal tract to grow and develop.
Croatian: Palifermin potiče rast posebnih stanica koje se nazivaju epitelne stanice, a oblikuju tkivo kojim su obložena Vaša usta i probavna cijev, kao i druga tkiva poput kože.
English: The remaining three doses are given on three consecutive days after myeloablative therapy, with the first dose given on the day of the stem-cell transplant.
Croatian: Palifermin je primijenjen u obliku dnevne intravenske injekcije od 60 mikrograma/kg kroz 3 uzastopna dana prije početka citotoksične terapije i kroz 3 uzastopna dana nakon infuzije progenitornih stanica iz periferne krvi s devet dana razmaka između posljednje doze prije i prve doze nakon terapije.
English: The main measure of effectiveness was the number of days during which patients experienced severe oral
Croatian: Primarni ishod ispitivanja bio je broj dana tijekom kojih su bolesnici imali težak oblik oralnog mukozitisa (stupnja 3/4 prema ljestvici Svjetske zdravstvene organizacije (SZO)).
English: Kepivance has been compared with placebo (a dummy treatment) in one main study in 212 adults receiving chemotherapy and radiotherapy for a blood cancer (mostly non-Hodgkin's lymphoma).
Croatian: visoke doze etopozida (60 mg/kg; dan -4) i visoke doze ciklofosfamida (100 mg/kg; dan -2), nakon čega je primijenjena infuzija progenitornih stanica iz periferne krvi za liječenje hematoloških malignih bolesti (ne-Hodgkinovog limfoma (NHL), Hodgkinove bolesti, akutne mijeloične leukemije