FrancophonIA/ELRC3.0 huggingface dataset:
English: • poor bone marrow function or low blood cell counts (red cells, white cells or platelets) caused by conditions other than rheumatoid or psoriatic arthritis;
Croatian: • slabom funkcijom koštane srži ili niskim brojem krvnih stanica (crvenih ili bijelih ili krvnih pločica)
English: How does Leflunomide Zentiva work?
Croatian: Kako djeluje Leflunomide Zentiva?
English: What benefits of Leflunomide Zentiva have been shown in the studies?
Croatian: Koje su koristi od lijeka Leflunomide Zentiva utvrđene u ispitivanjima?
English: For the full list of side effects with Leflunomide Zentiva, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Leflunomide Zentiva potražite u uputi o lijeku.
English: The doctor should carry out blood tests to check the patient's liver, white blood cell counts and platelet counts before prescribing Leflunomide Zentiva, and regularly during treatment.
Croatian: Prije nego što liječnik propiše lijek Leflunomide Zentiva, kao i redovito tijekom terapije, treba obavljati pretrage krvne slike bolesnika kako bi se provjerilo stanje jetre te razine bijelih krvnih stanica i trombocita.
English: It is available as tablets (0.5 and 1 mg).
Croatian: Dostupan je kao tablete (0.5 i 1 mg).
English: The tablets are swallowed whole with water.
Croatian: Tablete treba progutati cijele s vodom.
English: This summary was last updated in 03-2014.
Croatian: Sažetak je posljednji put ažuriran 03. 2014.
English: Champix varenicline
Croatian: Champix vareniklin
English: The percentage in the patients who had taken bupropion was 16%.
Croatian: Postotak bolesnika koji su uzimali bupropion iznosio je 16%.
English: The full EPAR for Champix 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 Champix nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Treatment with Champix lasts for 12 weeks.
Croatian: Terapija lijekom Champix traje 12 tjedana.
English: For the remaining 11 weeks of treatment, the patient takes one 1 mg tablet twice a day.
Croatian: Tijekom preostalih 11 tjedana liječenja, bolesnik uzima jednu tabletu jačine 1 mg dvaput dnevno.
English: The main measure of effectiveness was the number of patients who had completely stopped smoking for four weeks (between week 9 and week 12 of the study), confirmed by laboratory testing of the patients' breath for signs of smoking.
Croatian: Glavna mjera djelotvornosti bio je broj bolesnika koji su u potpunosti prekinuli pušenje tijekom razdoblja od četiri tjedna (između 9. i 12. tjedna ispitivanja), što je potvrđeno laboratorijskim testiranjem daha bolesnika kako bi se uočili znakovi pušenja.
English: Reduced doses may be used in patients who do not tolerate the medicine or who have kidney problems.
Croatian: Slabije doze mogu se primjenjivati u bolesnika koji ne podnose lijek ili koji imaju problema s bubrezima.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Champix on 26 September 2006.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Champix vrijedi na prostoru Europske unije od 26. rujna 2006.
English: In the first week the patient takes one 0.5 mg tablet once a day for three days, followed by one 0.5 mg tablet twice a day for four days.
Croatian: Tijekom prvog tjedna bolesnik uzima jednu tabletu jačine 0,5 mg jednom na dan tijekom tri uzastopna dana, nakon čega slijedi jedna tableta jačine 0,5 mg dvaput dnevno tijekom četiri dana.
English: People who smoke become addicted to nicotine, a chemical in tobacco.
Croatian: Osobe koje puše postanu ovisne o nikotinu, kemikaliji u duhanu.
English: In both studies, Champix was more effective than bupropion or placebo in helping patients to stop smoking.
Croatian: U oba ispitivanja, Champix je bio djelotvorniji od bupropiona ili placeba u pomaganju bolesnicima da prestanu pušiti.
English: Champix is a medicine that contains the active substance varenicline.
Croatian: Champix je lijek koji sadrži djelatnu tvar vareniklin.
English: The most common side-effects with Champix (seen in more than 1 patient in 10) are nausea (feeling sick), insomnia (difficulty sleeping), abnormal dreams, headache and nasopharyngitis (inflammation of the nose and throat).
Croatian: Najčešće nuspojave lijeka Champix (kod više od 1 na 10 bolesnika) su mučnina (osjećaj slabosti), nesanica (problem sa spavanjem), abnormalni snovi, glavobolja i nazofaringitis (upala nosa i grla).
English: What measures are being taken to ensure the safe and effective use of Champix?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Champix?
English: This is a summary of the European public assessment report (EPAR) for Champix.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za Champix.
English: Other information about Champix
Croatian: Ostale informacije o lijeku Champix
English: In two main studies 2,052 smokers received 12-week treatment with Champix, bupropion (another non-nicotine medicine) or placebo (a dummy treatment).
Croatian: U dva glavna ispitivanja 2.052 pušača primilo je 12-tjedno liječenje lijekom Champix, bupropionom (drugim lijekom koji ne sadrži nikotin) ili placebom (lažnim liječenjem).
English: Treatment with Champix is more likely to succeed in smokers who are motivated to stop smoking and who are also receiving additional advice and support.
Croatian: Veća je vjerojatnost da će terapija lijekom Champix biti uspješna u bolesnika koji su motivirani za prestanak pušenja, te kojima su pruženi dodatni savjeti i potpora.
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 Champix.
Croatian: Objašnjava kako je Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) ocijenilo lijek da bi donijelo svoje mišljenje u korist davanja odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima za primjenu lijeka Champix.
English: The patients' target date for quitting was set at one week after starting treatment and the patients were followed up for a further 40 weeks after their treatment to see if they started smoking again.
Croatian: Datum prestanka pušenja za bolesnike određen je tjedan dana nakon početka liječenja, a bolesnici su praćeni do 40 tjedana nakon njihovog liječenja kako bi se vidjelo jesu li ponovno počeli pušiti.
English: Nicotine acts in the nervous system, where it binds to receptors and triggers the release of a chemical messenger, dopamine, which plays a part in the pleasure derived from smoking.
Croatian: Nikotin djeluje na živčani sustav, gdje se veže na receptore i aktivira otpuštanje kemijskog glasnika, dopamina, koji sudjeluje u osjećaju ugode izazvanom pušenjem.
English: The percentage of patients who had not smoked at all during weeks 9-12 was 44% with Champix, 30% with bupropion, and 18% with placebo.
Croatian: Postotak bolesnika koji nisu pušili tijekom razdoblja od 9. do 12. tjedna iznosio je 44% s lijekom Champix, 30% s bupropion i 18% s placebom.
English: Champix is used in adults to help them stop smoking.
Croatian: Champix se koristi u odraslih osoba kao pomoć pri odvikavanju od pušenja.
English: Another study compared Champix with placebo in patients who were allowed to choose their own target dates for quitting, which could be between one week and five weeks of starting treatment.
Croatian: Drugo je ispitivanje usporedilo Champix s placebom u bolesnika kojima je bilo dozvoljeno da odaberu svoje željene datume za prestanak pušenja, koji su mogli biti između tjedan dana i pet tjedana od početka liječenja.
English: A risk management plan has been developed to ensure that Champix is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Champix.
English: Patients who are unwilling or unable to set a target date within one to two weeks could be offered the treatment first and then later choose their target date to fall within five weeks of starting treatment.
Croatian: Bolesnicima, koji nisu voljni ili ne mogu odrediti datum u roku od jednog do dva tjedna, može se prvo ponuditi liječenje, a zatim se može odabrati datum prestanka pušenja koji se nalazi unutar pet tjedana od početka liječenja.
English: More patients remained non-smokers after treatment with Champix than after placebo: 40 weeks after the end of the treatment period, the percentage of patients who were still non-smokers was 23% among those who had taken Champix, and 9% among those who had taken a placebo.
Croatian: Više je bolesnika ostalo nepušačima nakon liječenja lijekom Champix nego nakon liječenja placebom: 40 tjedan po završetku liječenja, postotak bolesnika osoba koje su još uvijek bile nepušači iznosio je 23% u grupi koja je uzimala Champix, i 9% u grupi koja je uzimala placebo.
English: For patients who have successfully stopped smoking after 12 weeks of treatment, doctors may choose to carry on treatment for another 12 weeks.
Croatian: U slučaju bolesnika koji su se uspješno odviknuli od pušenja nakon 12 tjedana liječenja, liječnici mogu nastaviti s liječenjem tijekom narednih 12 tjedana.
English: For more information about treatment with Champix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Champix pročitajte u uputama o lijeku (također dio EPAR-a) odnosno obratite se svom liječniku ili ljekarniku.
English: When binding to these receptors, varenicline acts in two ways: it acts like nicotine (partial agonist) and this helps to relieve craving symptoms, but it also acts against nicotine (antagonist), by taking its place, and this helps to reduce the pleasurable effects of smoking.
Croatian: Prilikom vezanja na ove receptore, vareniklin djeluje na dva načina: djeluje kao nikotin (djelomičan agonist) te ovo pomaže pri ublažavanju simptoma žudnje, no djeluje i protiv nikotina (antagonist), uzimajući njegovo mjesto.
English: The CHMP concluded that the benefits of Champix outweigh its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je zaključio da koristi lijeka Champix nadmašuju s njim povezane rizike i preporučio je izdavanje odobrenja za stavljanje lijeka u promet.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Champix, 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 lijek Champix uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju primjenjivati.
English: The active substance in Champix, varenicline, can bind to some of these receptors, the α4β2 nicotinic acetylcholine receptors.
Croatian: Djelatna tvar lijeka Champix, vareniklin, može se vezati na pojedine receptore, receptore α4β2 nikotinskog acetilkolina.
English: In the study where patients were allowed to set their own target dates, Champix was also shown to be effective in helping patients to quit.
Croatian: U ispitivanju u kojem je bolesnicima bilo dozvoljeno da samo odrede datum prestanka pušenja, Champix se također pokazao djelotvornijim u pomaganju bolesnicima da prestanu pušiti.
English: What is the risk associated with Champix?
Croatian: Koji su rizici povezani s lijekom Champix?
English: Why has Champix been approved?
Croatian: Zašto je Champix odobren?
English: What is Champix?
Croatian: Što je Champix?
English: What benefit has Champix shown during the studies?
Croatian: Koje su koristi lijeka Champix dokazane u ispitivanjima?
English: How does Champix work?
Croatian: Kako djeluje Champix work?
English: Patients set themselves a target date for quitting and will usually start taking Champix one to two weeks before this date.
Croatian: S uzimanjem lijeka CHAMPIX obično treba započeti 1-2 tjedna prije toga datuma.
English: What is Champix used for?
Croatian: Za što se Champix koristi?
English: How is Champix used?
Croatian: Kako se Champix koristi?
English: For the full list of all side effects and restrictions with Champix, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Champix, potražite u uputi o lijeku.
English: How has Champix been studied?
Croatian: Kako se Champix ispitivao?
English: This summary was last updated in 11-2015.
Croatian: Sažetak je posljednji put ažuriran: 11.2015.
English: Patients who cannot swallow tablets may crush the tablets and add them to a small amount of food or drink immediately before swallowing it.
Croatian: Bolesnici koji ne mogu progutati tablete, mogu ih zdrobiti i dodati maloj količini hrane ili pića neposredno prije gutanja.
English: They both work in similar ways by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses.
Croatian: Obje djeluju na sličan način blokirajući djelovanje reverzne transkriptaze, enzima koji HIV proizvodi, a koji mu omogućuje da zarazi stanice i proizvodi više virusa.
English: The tablets should ideally be swallowed without crushing.
Croatian: Tablete bi se trebale progutati bez drobljenja.
English: Both active substances have been available in the EU for a number of years: lamivudine has been authorised as Epivir since 1996 and zidovudine has been available in the EU since the mid-1980s.
Croatian: Obje djelatne tvari godinama su dostupne na području EU-a: lamivudin je od 1996. odobren kao lijek Epivir, a zidovudin je dostupan na području EU-a od sredine 1980-ih.
English: The full EPAR for Lamivudine/Zidovudine Teva can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Lamivudin/Zidovudin Teva nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: In children (below 12 years of age) weighing between 14 and 30 kg, the number of tablets and half tablets to take depends on their weight.
Croatian: U djece (mlađe od 12 godina) s tjelesnom težinom između 14 i 30 kg broj tableta i polovica tableta koje je potrebno uzimati ovisi o njihovoj težini.
English: This means that Lamivudine/Zidovudine Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Combivir.
Croatian: To znači da je lijek Lamivudin/Zidovudin Teva sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Combivir.
English: If patients need to stop taking lamivudine or zidovudine, or need to take different doses because of problems with their kidneys, liver or blood, they will need to take medicines containing lamivudine or zidovudine separately.
Croatian: Ako bolesnici moraju prekinuti liječenje lamivudinom ili zidovudinom ili trebaju uzimati drugačije doze zbog problema s bubrezima, jetrom ili krvlju, trebaju odvojeno uzimati lijekove koji sadrže lamivudin ili zidovudin.
English: Lamivudine/Zidovudine Teva is a medicine that contains two active substances, lamivudine (150 mg) and zidovudine (300 mg).
Croatian: Lamivudin/Zidovudin Teva lijek je koji sadrži dvije djelatne tvari, lamivudin (150 mg) i zidovudin (300 mg).
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 Lamivudine/Zidovudine Teva.
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 te preporuke o uvjetima za primjenu lijeka Lamivudin/Zidovudin Teva.
English: Lamivudine/Zidovudine Teva does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Croatian: Lamivudin/Zidovudin Teva ne liječi ni infekciju HIV-om ni AIDS, no može odgoditi oštećenje imunosnog sustava te razvoj infekcija i bolesti povezanih s AIDS-om.
English: For more information about treatment with Lamivudine/Zidovudine Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Lamivudin/Zidovudin Teva pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Children weighing less than 14 kg will need to use separate oral solutions containing lamivudine and zidovudine.
Croatian: Djeca s tjelesnom težinom manjom od 14 kg trebaju uzimati zasebne oralne otopine koje sadrže lamivudin i zidovudin.
English: The recommended dose of Lamivudine/Zidovudine Teva for patients over 12 years of age who weigh at least 30 kg is one tablet taken twice a day.
Croatian: Preporučena doza lijeka Lamivudin/Zidovudin Teva za bolesnike starije od 12 godina i tjelesne težine najmanje 30 kg jedna je tableta dva puta na dan.
English: Lamivudine/Zidovudine Teva is a ‘generic medicine'.
Croatian: Lamivudin/Zidovudin Teva je „generički lijek”.
English: The CHMP concluded that, in accordance with EU requirements, Lamivudine/Zidovudine Teva has been shown to have comparable quality and to be bioequivalent to Combivir.
Croatian: CHMP je zaključio kako je, u skladu sa zahtjevima EU-a, potvrđeno kako Lamivudin/Zidovudin Teva posjeduje usporedivu kvalitetu te je bioekvivalentan s lijekom Combivir.
English: Because Lamivudine/Zidovudine Teva is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Lamivudin/Zidovudin Teva generički lijek, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Lamivudine/Zidovudine Teva on 28 February 2011.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Lamivudin/Zidovudin Teva na snazi u Europskoj uniji od 28. veljače 2011.
English: Both active substances in Lamivudine/Zidovudine Teva, lamivudine and zidovudine, are nucleoside reverse transcriptase inhibitors (NRTIs).
Croatian: Obje djelatne tvari lijeka Lamivudin/Zidovudin Teva, lamivudin i zidovudin, nukleozidni su inhibitori reverzne transkriptaze (NRTI).
English: Lamivudine/Zidovudine Teva is used in combination with at least one other HIV medicine to treat patients infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).
Croatian: Lamivudin/Zidovudin Teva koristi se u kombinaciji s najmanje jednim drugim lijekom za liječenje infekcije virusom humane imunodeficijencije (HIV) u bolesnika zaraženih HIV-om, virusom koji uzrokuje sindrom stečene imunodeficijencije (AIDS).
English: Treatment with Lamivudine/Zidovudine Teva should be started by a doctor who has experience in the management of HIV infection.
Croatian: Liječenje lijekom Lamivudin/Zidovudin Teva mora započeti liječnik s iskustvom u liječenju infekcija HIV-om.
English: This is a summary of the European public assessment report (EPAR) for Lamivudine/Zidovudine Teva.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Lamivudin/Zidovudin Teva.
English: What are the benefits and risks of Lamivudine/Zidovudine Teva?
Croatian: Koje su koristi i rizici lijeka Lamivudin/Zidovudin Teva?
English: Because Lamivudine/Zidovudine Teva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Combivir.
Croatian: Budući da je Lamivudin/Zidovudin Teva generički lijek, ispitivanja na bolesnicima bila su ograničena na utvrđivanje činjenice je li riječ o bioekvivalentu referentnom lijeku Combivir.
English: Lamivudine/Zidovudine Teva lamivudine/zidovudine
Croatian: Lamivudin/Zidovudin Teva lamivudin/zidovudin
English: Other information about Lamivudine/Zidovudine Teva
Croatian: Ostale informacije o lijeku Lamivudin/Zidovudin Teva
English: Children taking Lamivudine/Zidovudine Teva should be closely monitored for side effects.
Croatian: Potrebno je pomno pratiti djecu koja uzimaju Lamivudin/Zidovudin Teva zbog mogućnosti nuspojava.
English: Therefore, the CHMP's view was that, as for Combivir, the benefit outweighs the identified risk.
Croatian: Stoga je stav Odbora kako koristi nadmašuju utvrđene rizike, kao i kod lijeka Combivir.
English: Lamivudine/Zidovudine Teva, taken in combination with at least one other HIV medicine, reduces the amount of HIV in the blood and keeps it at a low level.
Croatian: Kad se uzima u kombinaciji s najmanje još jednim drugim lijekom za liječenje infekcije HIV-om, Lamivudin/Zidovudin Teva smanjuje koncentraciju HIV-a u krvi i održava je niskom.
English: What is Lamivudine/Zidovudine Teva?
Croatian: Što je Lamivudin/Zidovudin Teva?
English: Why has Lamivudine/Zidovudine Teva been approved?
Croatian: Zašto je lijek Lamivudin/Zidovudin Teva odobren?
English: The Committee recommended that Lamivudine/Zidovudine Teva be given marketing authorisation.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Lamivudin/Zidovudin Teva u EU-u.
English: What is Lamivudine/Zidovudine Teva used for?
Croatian: Za što se Lamivudin/Zidovudin Teva koristi?
English: How does Lamivudine/Zidovudine Teva work?
Croatian: Kako djeluje Lamivudin/Zidovudin Teva?
English: How has Lamivudine Zidovudine Teva been studied?
Croatian: Kako je lijek Lamivudin/Zidovudin Teva ispitivan?
English: How is Lamivudine/Zidovudine Teva used?
Croatian: Kako se Lamivudin/Zidovudin Teva koristi?
English: ATCvet code: QP54AA05.
Croatian: ATCvet kod: QP54AA05.
English: Do not smoke, eat or drink while handling the product.
Croatian: Nemojte pušiti, jesti i piti dok rukujete proizvodom.
English: Animals older than six weeks of age:
Croatian: Životinje starije od šest tjedana:
English: Do not administer orally or parenterally.
Croatian: Ne primjenjivati oralno ili parenteralno.
English: Avoid contact between the product and your fingers.
Croatian: Izbjegavajte kontakt proizvoda i prstiju.
English: This product is not effective against adult D. immitis.
Croatian: Ovaj proizvod nije učinkovit protiv odrasle D. immitis.
English: Date of first authorisation: 17/04/2019
Croatian: Datum prvog odobrenja: 17/04/2019
English: Remove the product pipette from its protective package.
Croatian: Izvadite pipetu proizvoda iz zaštitnog pakiranja.
English: On the day of treatment, children must not handle treated animals and the animals should not be permitted to sleep with their owners, especially children.
Croatian: Na dan liječenja, djeca ne bi smjela rukovati tretiranim životinjama, a životinjama ne bi smjelo biti dozvoljeno spavati kraj svojih vlasnika, posebice djece.
English: None known.
Croatian: Nisu poznati.
English: Interactions with other medicinal products and other forms of interaction: None known.
Croatian: Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija: Nisu poznati.
English: Images for optional inclusion should space allow
Croatian: Slike za neobavezno uključivanje trebaju dopustiti prostor
English: Used applicators should be disposed of immediately and not left within the sight or reach of children.
Croatian: Iskorištene aplikatore treba odmah odložiti i ne bi se smjelo ostavljati unutar pogleda i dosega djece.
English: Medicines should not be disposed of via wastewater.
Croatian: Lijekovi se ne bi smjeli bacati u otpadne vode.
English: The product is a skin and eye irritant.
Croatian: Proizvod je iritantan za kožu i oči.
English: Do not use in animals under 6 weeks of age.
Croatian: Ne primjenjivati na životinjama mlađima od 6 tjedana.
English: Each single-dose (pipette) delivers:
Croatian: Svaka pojedinačna doza (pipeta) sadrži: