FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Armisarte has been shown to be comparable to Alimta.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da je u skladu sa zahtjevima EU-a dokazano da je lijek Armisarte usporediv s lijekom Alimta.
English: Armisarte is available as a concentrate for solution for infusion into a vein.
Croatian: Armisarte dostupan je kao koncentrat za otopinu za infuziju u venu.
English: In the body, pemetrexed is converted into an active form that blocks the activity of the enzymes that are involved in producing ‘nucleotides' (the building blocks of DNA and RNA, the genetic material of cells).
Croatian: U tijelu se pemetreksed konvertira u djelatni oblik koji blokira djelovanje enzima koji su uključeni u proizvodnju „nukleotida” (stanica koje grade DNK i RNK, genetski materijal stanica).
English: The conversion of pemetrexed into its active form occurs more readily in cancer cells than in normal cells, leading to higher levels of the active form of the medicine and a longer duration of action in cancer cells.
Croatian: Konverzija pemetrekseda u njegov djelatni oblik nastupa prije u stanicama raka nego u normalnim stanicama, što rezultira većim razinama djelatnog oblika lijeka i duljim djelovanjem u stanicama raka.
English: Because Armisarte is a hybrid medicine that is given by infusion and contains the same active substance as the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Armisarte hibridni lijek koji se daje infuzijom i sadrži istu djelatnu tvar kao i referentni lijek, njegove koristi i rizici isti su kao i oni kod referentnog lijeka.
English: The Committee recommended that Armisarte be approved for use in the EU.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Armisarte u EU-u.
English: As a result, the active form of pemetrexed slows down the formation of DNA and RNA and prevents the cells from dividing and multiplying.
Croatian: Kao rezultat toga djelatni oblik pemetrekseda usporava formiranje DNK-a i RNK-a te sprječava dijeljenje i umnožavanje stanica.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Armisarte, 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 o lijeku za lijek Armisarte nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: This results in the division of cancer cells being reduced, while normal cells are only slightly affected.
Croatian: Kao rezultat toga dolazi do manje podjele stanica raka, pri čemu je utjecaj na normalne stanice tek neznatan.
English: For more information about treatment with Armisarte, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Armisarte pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: • malignant pleural mesothelioma (a cancer of the lining of the lungs that is usually caused by exposure to asbestos), where it is used together with cisplatin in patients who have not received chemotherapy before and whose cancer cannot be removed by surgery;
Croatian: • malignog pleuralnog mezotelioma (rak ovojnice pluća koji je obično uzrokovan izlaganjem azbestu), pri čemu se koristi u kombinaciji s cisplatinom u bolesnika s neoperabilnim rakom koji prethodno nisu primali kemoterapiju;
English: • advanced non-small-cell lung cancer of the kind known as ‘non-squamous', where it is used either in combination with cisplatin in previously untreated patients or on its own in patients who have previously received cancer treatment.
Croatian: • uznapredovalog raka pluća nemalih stanica vrste poznate pod nazivom „neskvamozne stanice”, kada se koristi u kombinaciji s cisplatinom u prethodno neliječenih bolesnika ili kao monoterapija u bolesnika koji su prethodno primili terapiju protiv raka.
English: No additional studies were needed as Armisarte is a hybrid medicine that is given by infusion and contains the same active substance as the reference medicine, Alimta.
Croatian: Nisu bila potrebna dodatna ispitivanja jer je Armisarte hibridni lijek koji se daje infuzijom i sadrži istu djelatnu tvar kao i referentni lijek Alimta.
English: When Armisarte is given with cisplatin, an ‘anti-emetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Croatian: Ako se Armisarte primjenjuje s cisplatinom, prije ili nakon doze cisplatina bolesniku također treba dati „antiemetik” (za sprječavanje povraćanja) i tekućinu (za sprječavanje dehidracije).
English: Therefore, the CHMP's view was that, as for Alimta, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da, kao i kod lijeka Alimta, koristi nadmašuju utvrđene rizike.
English: To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Armisarte.
Croatian: Kako bi se ublažile nuspojave lijeka, bolesnici tijekom terapije lijekom Armisarte trebaju uzimati kortikosteroid (tip lijeka koji smanjuje upalu) i folnu kiselinu (tip vitamina) te primati injekcije vitamina B12.
English: While Alimta is available as a powder to be made up into a solution for infusion (drip) into a vein, Armisarte is available as a concentrated liquid to be made up into a solution for infusion.
Croatian: Lijek Alimta dostupan je u obliku praška od kojeg se radi otopina za infuziju (drip) u venu, a Armisarte dostupan je u obliku koncentrirane tekućine od koje se radi otopina za infuziju.
English: How does Armisarte work?
Croatian: Kako djeluje Armisarte?
English: How is Armisarte used?
Croatian: Kako se Armisarte koristi?
English: The active substance in Armisarte, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites'.
Croatian: Djelatna tvar lijeka Armisarte, pemetreksed, citotoksičan je lijek (lijek koji uzrokuje smrt stanica koje se dijele, kao što su stanice karcinoma), a ubraja se u grupu „antimetabolita”.
English: Treatment should be delayed or stopped, or the dose reduced, in patients whose blood counts are abnormal or who have certain other side effects.
Croatian: U bolesnika čiji broj krvnih tjelešca nije normalan ili koji imaju određene druge nuspojave terapiju treba odgoditi ili prekinuti, odnosno dozu treba smanjiti.
English: For practical information about using Armisarte, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Armisarte pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: For more information, see the summary of product characteristics (also part of the EPAR).
Croatian: Dodatne informacije možete pronaći u sažetku opisa svojstava lijeka (također dio EPAR-a).
English: How has Armisarte been studied?
Croatian: Kako je Armisarte ispitivan?
English: Armisarte contains the active substance pemetrexed.
Croatian: Armisarte sadrži djelatnu tvar pemetreksed.
English: This summary was last updated in 08-2013.
Croatian: Sažetak je posljednji put obnovljen 08.2013.
English: A risk management plan has been developed to ensure that Vipidia is used as safely as possible.
Croatian: Razvijen je plan upravljanja rizikom kako bi se osiguralo da se Vipidia koristi što je sigurnije moguće.
English: Other information about Vipidia
Croatian: Druge informacije o lijeku Vipidia
English: The full EPAR for Vipidia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Vipidia može se naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vipidia on 19 September 2013.
Croatian: Europska komisija izdaje odobrenje za stavljanje u promet koje za lijek Vipidia vrijedi na prostoru Europske unije od na 19. rujna 2013.
English: Vipidia is available as tablets (6.25, 12.5 and 25 mg) and can only be obtained with a prescription.
Croatian: Lijek Vipidia dostupan je u tabletama (6,25; 12,5 i 25 mg) i izdaje se samo na liječnički recept.
English: It is not intended to provide practical advice on how to use Vipidia.
Croatian: Svrha sažetka nije davati praktične savjete o načinu korištenja lijeka Vipidia.
English: What measures are being taken to ensure the safe and effective use of Vipidia?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Vipidia?
English: What is Vipidia and what is it used for?
Croatian: Što je Vipidia i za što se koristi?
English: It works by blocking the breakdown of ‘incretin' hormones in the body.
Croatian: Djeluje inhibirajući razgradnju „inkretinskih“ hormona u tijelu.
English: The most common side effect with Vipidia (which may affect up to 1 in 10 people) is pruritus (itching).
Croatian: Najčešća nuspojava s lijekom Vipidia (koja se može javiti u više od 1 na 10 osoba) jest pruritus (svrbež).
English: Why is Vipidia approved?
Croatian: Zašto je Vipidia odobren?
English: Vipidia has been studied in seven main studies involving 5,675 adults with type 2 diabetes.
Croatian: Lijek Vipidia ispitan je u sedam glavnih ispitivanja koja su obuhvatile 5.675 odraslih osoba sa šećernom bolešću tipa
English: In patients with reduced kidney function, the daily dose of Vipidia should be reduced.
Croatian: U bolesnika sa smanjenom funkcijom bubrega treba smanjiti dnevnu dozu lijeka Vipidia.
English: The recommended dose is 25 mg taken by mouth once daily, in combination with other diabetes medicines as prescribed by a doctor.
Croatian: Preporučena doza je 25 mg i uzima se oralno jedanput na dan, u kombinaciji s drugim antidijabeticima kako propiše liječnik.
English: Vipidia must not be used in patients who are hypersensitive (allergic) to the active substances or any of the ingredients or who have had serious allergic reactions to any DPP 4 inhibitor.
Croatian: Lijek Vipidia ne smije se koristiti u bolesnika koji su preosjetljivi (alergični) na djelatne tvari odnosno bilo koji drugi sastojak ili koji su imali ozbiljnu alergijske reakcije na bilo koji inhibitor DPP 4.
English: What are the risks associated with Vipidia?
Croatian: Koji su rizici povezani s lijekom Vipidia?
English: The active substance in Vipidia, alogliptin, is a dipeptidyl-peptidase-4 (DPP 4) inhibitor.
Croatian: Djelatna tvar u lijeku Vipidia, alogliptin, je inhibitor dipeptidil-peptidaze-4 (DPP 4).
English: These hormones are released after a meal and stimulate the pancreas to produce insulin.
Croatian: Ovi se hormoni otpuštaju nakon obroka i stimuliraju gušteraču na proizvodnju inzulina.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Vipidia's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji odlučilo je da koristi lijeka Vipidia nadmašuju s njim povezane rizike te je preporučilo njegovo odobrenje za korištenje u Europskoj uniji.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vipidia, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku za Vipidia uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: When Vipidia is added to a sulphonylurea (a type of diabetes medicine) or insulin, the doctor may need to lower the dose of these medicines to reduce the risk of hypoglycaemia (low blood sugar level).
Croatian: Nakon što se Vipidia doda u sulfonilureju (tip antidijabetika) ili inzulin, liječnik će možda morati sniziti dozu ovih lijekova kako bi se smanjio rizik od hipoglikemije (niske razine šećera u krvi).
English: Alogliptin does not work when the blood glucose is low.
Croatian: Alogliptin ne djeluje ako su razine glukoze u krvi niske.
English: This is a summary of the European public assessment report (EPAR) for Vipidia.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Vipidia.
English: HbA1c levels give an indication of how well the blood glucose is controlled.
Croatian: Razine HbA1c ukazuju koliko se dobro kontrolira glukoza u krvi.
English: Alogliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Croatian: Alogliptin također snižava količinu glukoze koju proizvodi jetra tako što povećava razine inzulina i snižava razine hormonskog glukagona.
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Croatian: Šećerna bolest tipa 2 jest bolest koja nastupa kada gušterača ne proizvodi dovoljno inzulina za kontrolu razine glukoze u krvi ili kada tijelo ne može učinkovito koristiti inzulin.
English: Regarding its safety, Vipidia's safety profile was consistent with that seen with other DPP-4 inhibitors.
Croatian: Vezano uz sigurnost, sigurnosni profil lijeka Vipidia bio je konzistentan s profilom viđenim u drugih inhibitora DPP-4.
English: Together, these processes reduce blood glucose levels and help to control type-2 diabetes.
Croatian: Ovi procesi zajedno snižavaju razine glukoze u krvi i pomažu pri kontroli šećerne bolesti tipa 2.
English: When used alone or in combination with other anti-diabetes medicines, Vipidia reduced HbA1c levels by 0.48-0.61% more than placebo.
Croatian: Ako se koristi kao monoterapija ili u kombinaciji s drugim antidijabeticima, lijek Vipidia smanjuje razine HbA1c za 0,48 - 0,61% više od placeba.
English: What benefits of Vipidia have been shown in studies?
Croatian: Koje koristi lijeka Vipidia su dokazane u ispitivanjima?
English: It is used, together with diet and exercise, as an addition to other diabetes medicines in adults with type 2 diabetes, to control their blood glucose (sugar) level.
Croatian: Koristi se zajedno s dijetom i tjelovježbom kao dodatak drugim antidijabeticima u odraslih osoba sa šećernom bolešću tipa 2 za kontrolu njihove razine glukoze (šećera) u krvi.
English: By blocking the breakdown of incretin hormones in the blood, alogliptin prolongs their action in stimulating the pancreas to produce more insulin when blood glucose levels are high.
Croatian: Inhibiranjem razgradnje inkretinskih hormona u krvi, alogliptin produžuje njihovo djelovanje pri stimulaciji gušterače kako bi gušterača proizvela više inzulina kada su razine glukoze u krvi visoke.
English: For practical information about using Vipidia, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Vipidia bolesnici trebaju pročitati u uputi o lijeku ili se obratiti svom liječniku ili ljekarniku.
English: For more information about treatment with Vipidia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Vipidia pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: In all of the studies, the main measure of effectiveness was the change in the level of glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood that has glucose attached.
Croatian: U svim je ispitivanjima glavna mjera djelotvornosti bila promjena u razini glikoziliranog hemoglobina (HbA1c), odnosno postotka hemoglobina u krvi na koji je vezana glukoza.
English: HbA1c levels were measured after 26 weeks when Vipidia was used alone or added to other diabetes medicines, and after 52 weeks when Vipidia was compared with glipizide or pioglitazone.
Croatian: Razine HbA1c izmjerene su nakon 26 tjedana u slučajevima kada se lijek Vipidia koristio kao monoterapija ili zajedno s drugim antidijabeticima, i nakon 52 tjedna u slučajevima kada se lijek Vipidia usporedio s glizidom ili pioglitazonom.
English: How does Vipidia work?
Croatian: Kako Vipidia djeluje?
English: For further information, see the package leaflet.
Croatian: Za dodatne informacije vidjeti uputu o lijeku.
English: Five of the studies compared Vipidia with placebo (a dummy treatment), when used alone or added to other diabetes medicines, in patients in whom previous treatment had failed.
Croatian: Pet ispitivanja usporedilo je lijek Vipidia s placebom (lažnim liječenjem), u slučaju kada se koristi kao monoterapija ili se dodaje drugim antidijabeticima, u bolesnika u kojih prethodno liječenje nije bilo uspješno.
English: In two other studies, Vipidia was compared with the diabetes medicines glipizide and pioglitazone in patients who were already taking metformin.
Croatian: U druga dva ispitivanja lijek Vipidia uspoređen je s antidijabeticima glipizidom i pioglitazonom u bolesnika koji su već uzimali metformin.
English: Vipidia was as least as affective as pioglitazone in lowering HbA1c when added to metformin, but the study comparing Vipidia with glipizide was not conclusive.
Croatian: Lijek Vipidia bio je barem podjednako učinkovit kao pioglitazon u smanjivanju razine HbA1c kad je bio dodan metforminu, no ispitivanje koje je uspoređivalo lijek Vipidia s glipizidom nije dao jasne rezultate.
English: Vipidia is a diabetes medicine that contains the active substance alogliptin.
Croatian: Vipidia jest antidijabetik koji sadrži djelatnu tvar alogliptin.
English: The CHMP considered that the effects of Vipidia on HbA1c levels were similar to those of other DPP-4 inhibitors and were modest but clinically relevant.
Croatian: CHMP smatra da je djelovanje lijeka Vipidia na razine HbA1c slično djelovanju drugih inhibitora DPP-4, te da je to djelovanje bilo neznatno, ali klinički relevantno.
English: How is Vipidia used?
Croatian: Kako se Vipidia koristi?
English: In all studies Vipidia led to a decrease in HbA1c indicating that blood glucose levels had been reduced.
Croatian: U svim ispitivanjima, lijek Vipidia uzrokovao je snižavanje razine HbA1c, što ukazuje da su razine glukoze snižene.
English: For the full list of all side effects reported with Vipidia, see the package leaflet.
Croatian: Potpuni popis nuspojava koje su zabilježene s lijekom Vipidia, potražite u uputi o lijeku.
English: The full EPAR for Thymanax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Thymanax nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Symptoms often include deep sadness, feelings of worthlessness, loss of interest in favourite activities, sleep disturbances, a feeling of being slowed down, feelings of anxiety and changes in weight.
Croatian: Simptomi često uključuju duboku tugu, osjećaje bezvrijednosti, gubitak zanimanja za omiljene aktivnosti, poremećaje spavanja, osjećaj usporenosti, anksioznost i promjene težine.
English: The recommended dose is one tablet once a day, taken at bedtime.
Croatian: Preporučena doza je jedna tableta jednom na dan, koja se uzima neposredno prije spavanja.
English: The main measure of effectiveness was the number of patients whose symptoms returned during 24 to 26 weeks of treatment.
Croatian: Glavna mjera djelotvornosti bio je broj bolesnika čiji su se simptomi vratili tijekom 24 do 26 tjedana liječenja.
English: If there is no improvement in symptoms after two weeks, the doctor may increase the dose to two tablets taken together at bedtime.
Croatian: Ako nakon dva tjedna nema poboljšanja simptoma, liječnik može povećati dozu na dvije tablete koje se uzimaju zajedno neposredno prije spavanja.
English: ‘Neurotransmitters' are chemicals that allow nerve cells to communicate with each other.
Croatian: „Neuroprijenosnici” su kemijske tvari koje omogućuju međusobnu komunikaciju živčanih stanica.
English: Thymanax can only be obtained with a prescription and is available as tablets (25 mg).
Croatian: Thymanax se izdaje samo na recept i dostupan je u obliku tableta (25 mg).
English: The patient's liver function should be checked with blood tests before starting treatment and when the dose is increased, followed by further tests around 3, 6, 12 and 24 weeks later.
Croatian: Krvnim pretragama treba provjeriti funkciju jetre bolesnika prije početka terapije te prilikom povećanja doze, a nakon toga dodatne pretrage treba obaviti nakon otprilike 3, 6, 12 i 24 tjedna.
English: It works in two ways, by stimulating the MT1 and MT2 receptors and by blocking the 5-HT2C receptors in the brain.
Croatian: Djeluje na dva načina, i to stimulirajući receptore MT1 i MT2 te inhibirajući receptore tipa 5-HT2C u mozgu.
English: Major depression is a condition in which patients have mood disturbances that interfere with their everyday life.
Croatian: Teška depresija je stanje u kojem bolesnici imaju poremećaje raspoloženja koji ih ometaju u svakodnevnom životu.
English: Thymanax might also help to normalise the patient's sleep patterns.
Croatian: Thymanax može također pomoći pri normalizaciji režima spavanja bolesnika.
English: Since dopamine and noradrenaline are involved in the control of mood, their increase between nerve cells in the brain is believed to help relieve the symptoms of depression.
Croatian: Budući da dopamin i noradrenalin sudjeluju u kontroli raspoloženja, vjeruje se da njihovo povećanje među živčanim stanicama u mozgu pomaže pri ublažavanju simptoma depresije.
English: Patients with depression should be treated for at least six months to make sure that they are free of symptoms.
Croatian: Osobe koje boluju od depresije trebaju se liječiti barem šest mjeseci kako bi se zajamčilo da više nemaju simptome.
English: This is thought to lead to increases in the levels of the neurotransmitters dopamine and noradrenaline.
Croatian: Smatra se da to uzrokuje povećanje razina neuroprijenosnika dopamina i noradrenalina.
English: Thymanax agomelatine
Croatian: Thymanax agomelatin
English: Most side effects were mild or moderate in intensity, happened within the first two weeks of treatment and were temporary.
Croatian: Većina nuspojava bila je blagog ili umjerenog intenziteta, nastupila je tijekom prva dva tjedna liječenja i bila je prolazna.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Thymanax on 19 February 2009.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Thymanax na snazi u Europskoj uniji od 19. veljače 2009.
English: Thymanax is a medicine used to treat major depression in adults.
Croatian: Thymanax je lijek koji se koristi za liječenje teške depresije u odraslih osoba.
English: Treatment should be discontinued immediately if the patient develops symptoms or signs of potential liver injury.
Croatian: Terapija se mora odmah prekinuti ako se kod bolesnika pojave simptomi ili znakovi mogućeg oštećenja jetre.
English: The main measure of effectiveness in these five studies was the change in symptoms after six weeks, as measured on a standard scale for depression called the Hamilton Depression Rating Scale (HAM D).
Croatian: Glavna mjera djelotvornosti u tih pet ispitivanja bila je promjena simptoma nakon šest tjedana, izmjerenih standardnom ocjenskom ljestvicom za depresiju naziva Hamiltonova ocjenska ljestvica za depresiju (Depression Rating ScaleHAM D).