FrancophonIA/ELRC3.0 huggingface dataset:
English: It is particularly important to tell your doctor if you are using the following medicines: - other medicines for rheumatoid arthritis or psoriasis, such as leflunomide, azathioprine (also used to prevent rejection after an organ transplant), sulfasalazine (also used for ulcerative colitis) - ciclosporin (for supressing the immune system) - non-steroidal anti-inflammatory drugs or salicylates (medicines against pain and/or inflammation such as acetylsalicylic acid, diclofenac and ibuprofen or pyrazole) - live vaccines
Croatian: − nesteroidne protuupalne lijekove ili salicilate (lijekove protiv bolova i/ili upale kao što su acetilsalicilatna kiselina, diklofenak i ibuprofen ili pirazol)
English: Oral use
Croatian: PRIMJENU
English: Hepatic impairment
Croatian: − živa cjepiva
English: If methotrexate comes into contact with skin or mucosa, it should be washed immediately and thoroughly with soap and water.
Croatian: treba ga odmah temeljito oprati sapunom i vodom.
English: This summary was last updated in 11-2016.
Croatian: Sažetak je posljednji put ažuriran: 11. 2016.
English: The medicine is available as tablets (15, 30 and 45 mg) and the recommended starting dose is 15 or 30 mg once a day.
Croatian: Lijek je dostupan u obliku tableta (15, 30 i 45 mg), a preporučena početna doza je 15 ili 30 mg jedanput dnevno.
English: This means that Pioglitazone Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
Croatian: To znači da je Pioglitazone Accord sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Actos.
English: The full EPAR for Pioglitazone Accord 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 Pioglitazone Accord nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Pioglitazone Accord pioglitazone
Croatian: Pioglitazone Accord pioglitazon
English: As a consequence, the blood glucose levels are reduced and this helps to control type 2 diabetes.
Croatian: Posljedica toga je smanjenje razine glukoze u krvi, što pomaže pri kontroli dijabetesa tipa 2.
English: Pioglitazone Accord is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight.
Croatian: Lijek Pioglitazone Accord primjenjuje se za liječenje dijabetesa tipa 2 u odraslih osoba (u dobi od 18 godina i starijih), osobito u onih prekomjerne tjelesne težine.
English: The active substance in Pioglitazone Accord, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Croatian: Djelatna tvar u lijeku Pioglitazone Accord, pioglitazon, čini stanice (masti, mišića i jetre) osjetljivijima na inzulin, što znači da tijelo bolje iskorištava inzulin koji proizvodi.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pioglitazone Accord on 21 March 2012.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Pioglitazone Accord u promet koje vrijedi na prostoru Europske unije od 21. ožujka 2012.
English: The company that markets Pioglitazone Accord will produce educational material for doctors prescribing the medicine, which will cover the possible risk of heart failure and bladder cancer with treatments that contain pioglitazone, the criteria for selecting patients and the need to review treatment regularly and stop treatment if patients are no longer benefiting.
Croatian: Tvrtka koja stavlja na tržište lijek Pioglitazone Accord osigurat će edukativni materijal za liječnike koji propisuju taj lijek koji će obuhvaćati informacije o mogućem riziku od srčanog zastoja i raka mjehura u liječenjima u kojima se primjenjuje pioglitazon, o kriterijima za odabir bolesnika te potrebi za redovitim procjenjivanjem učinaka terapije i prekidom liječenja ako bolesnici više nemaju koristi od njega.
English: Pioglitazone Accord is a ‘generic medicine'.
Croatian: Pioglitazone Accord je „generički lijek”.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pioglitazone Accord has been shown to have comparable quality and to be bioequivalent to Actos.
Croatian: Odbor za lijekove za humanu uporabu(CHMP) pri Agenciji zaključio je kako je, u skladu sa zahtjevima EU-a, lijek Pioglitazone Accord dokazao usporedivu kakvoću te da je bioekvivalentan lijeku Actos.
English: What measures are being taken to ensure the safe and effective use of Pioglitazone Accord?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Pioglitazone Accord?
English: Therefore, the CHMP's view was that, as for Actos, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da korist nadmašuje identificirani rizik, kao i za Actos.
English: What is Pioglitazone Accord and what is it used for?
Croatian: Što je Pioglitazone Accord i za što se koristi?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pioglitazone Accord have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Pioglitazone Accord nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: It is not intended to provide practical advice on how to use Pioglitazone Accord.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Pioglitazone Accord.
English: This is a summary of the European public assessment report (EPAR) for Pioglitazone Accord.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Pioglitazone Accord.
English: Treatment with Pioglitazone Accord should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit.
Croatian: Nakon tri do šest mjeseci liječenja lijekom Pioglitazone Accord potrebno je procijeniti učinke liječenja i prekinuti ga u bolesnika u kojih nisu vidljive dostatne koristi.
English: Because Pioglitazone Accord 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 lijek Pioglitazone Accord generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i kod referentnog lijeka.
English: Other information about Pioglitazone Accord
Croatian: Ostale informacije o lijeku Pioglitazone Accord
English: What are the benefits and risks of Pioglitazone Accord?
Croatian: Koje su koristi i rizici lijeka Pioglitazone Accord?
English: For more information about treatment with Pioglitazone Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Pioglitazone Accord pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: The Committee recommended that Pioglitazone Accord be approved for use in the EU.
Croatian: Odbor je preporučio davanje odobrenja za stavljanje lijeka Pioglitazone Accord u promet u EU-u.
English: Pioglitazone Accord can only be obtained with a prescription.
Croatian: Lijek Pioglitazone Accord izdaje se samo na recept.
English: • in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of diabetes medicine) when metformin is not suitable in patients who are not satisfactorily controlled on a sulphonylurea alone;
Croatian: • u kombinaciji s metforminom u bolesnika u kojih se ne može postići zadovoljavajuća kontrola samo metforminom, ili sulfonilurejom (drugom vrstom lijeka za liječenje dijabetesa) ako metformin nije prikladan u bolesnika koji se ne mogu zadovoljavajuće kontrolirati samo sulfonilurejom;
English: • on its own in patients for whom metformin (another diabetes medicine) is not suitable.
Croatian: • kao monoterapija u bolesnika kojima metformin (drugi lijek za liječenje dijabetesa) nije prikladan;
English: Pioglitazone Accord contains the active substance pioglitazone.
Croatian: Pioglitazone Accord sadrži djelatnu tvar pioglitazon.
English: Because Pioglitazone Accord is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Croatian: Budući da je lijek Pioglitazone Accord generički lijek, ispitivanja na ljudima bila su ograničena na utvrđivanje činjenice je li lijek bioekvivalentan referentnom lijeku Actos.
English: For practical information about using Pioglitazone Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Pioglitazone Accord bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: Why is Pioglitazone Accord approved?
Croatian: Zašto je lijek Pioglitazone Accord odobren?
English: How does Pioglitazone Accord work?
Croatian: Kako djeluje Pioglitazone Accord?
English: How has Pioglitazone Accord been studied?
Croatian: Kako je Pioglitazone Accord ispitivan?
English: How is Pioglitazone Accord used?
Croatian: Kako se Pioglitazone Accord koristi?
English: What is Opsumit and what is it used for?
Croatian: Što je Opsumit i za što se koristi?
English: This overview was last updated in 07-2018.
Croatian: Ovaj pregled informacija posljednji je put ažuriran u 07. 2018.
English: Women should also not become pregnant for one month after stopping treatment.
Croatian: Žene ne smiju zatrudnjeti mjesec dana nakon prekida liječenja.
English: What measures are being taken to ensure the safe and effective use of Opsumit?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Opsumit?
English: The medicine is available as 10 mg tablets and taken at a dose of one tablet every day.
Croatian: Lijek je dostupan u obliku tableta od 10 mg, a primjenjuje se u dozi od jedne tablete jedanput dnevno.
English: In animal studies, Opsumit was shown to have an adverse effect on the development of embryos.
Croatian: U ispitivanjima na životinjama dokazano je da Opsumit ima štetan učinak na razvoj embrija.
English: These are part of a natural mechanism in the body that can cause arteries to narrow.
Croatian: To su dijelovi prirodnog mehanizma u tijelu koji mogu uzrokovati suženje arterija.
English: The most common side effects with Opsumit (which may affect more than 1 in 10 people) include nasopharyngitis (inflammation of the nose and throat), anaemia (low red blood cell counts) and headache.
Croatian: Najčešće nuspojave lijeka Opsumit (koje se mogu javiti u više od 1 na 10 osoba) jesu nazofaringitis (upala nosa i grla), anemija (nizak broj crvenih krvnih stanica) i glavobolja.
English: Further information on Opsumit can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Opsumit možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In a main study involving 742 patients, Opsumit has been shown to reduce the risk of PAH-related illness, particularly the worsening of PAH symptoms.
Croatian: U glavnom ispitivanju u kojem su sudjelovala 742 bolesnika dokazano je da Opsumit smanjuje rizik od bolesti povezanih s PAH-om, posebno od pogoršavanja simptoma PAH-a.
English: Other information about Opsumit
Croatian: Ostale informacije o lijeku Opsumit
English: Around 37% of patients taking placebo had a worsening of their PAH symptoms compared with 24% of those who took Opsumit 10 mg.
Croatian: Približno 37 % bolesnika koji su uzimali placebo doživjeli su pogoršanje simptoma PAH-a u odnosu na 24 % bolesnika koji su uzimali Opsumit od 10 mg.
English: Side effects reported with Opsumit are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Opsumit pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Opsumit is a medicine used for the long-term treatment of pulmonary arterial hypertension (PAH).
Croatian: Opsumit je lijek koji se koristi za dugoročno liječenje plućne arterijske hipertenzije (PAH).
English: What are the risks associated with Opsumit?
Croatian: Koji su rizici povezani s lijekom Opsumit?
English: Why is Opsumit authorised in the EU?
Croatian: Zašto je lijek Opsumit odobren u EU-u?
English: The European Medicines Agency decided that Opsumit'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 Opsumit nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: It must also not be used in patients with severe reduction in liver function or high levels of liver enzymes in the blood.
Croatian: Ne smije se primjenjivati u bolesnika s ozbiljnim oštećenjem funkcije jetre ili visokim razinama jetrenih enzima u krvi.
English: As for all medicines, data on the use of Opsumit are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Opsumit kontinuirano se prate.
English: An overview of Opsumit and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Opsumit i zašto je odobren u EU-u
English: Further information on the orphan designation can be found on the European Medicines Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Više informacija lijekovima za rijetke bolesti nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Because more pressure is needed to force blood through the narrowed artery, this leads to high blood pressure in the lungs.
Croatian: Budući da je potreban veći tlak za pumpanje krvi kroz suženu arteriju, dolazi do visokog krvnog tlaka u plućima.
English: The class reflects the seriousness of the disease: patients with class II PAH have slight limitation of physical activity and those with class III disease have marked limitation of physical activity.
Croatian: Razred odražava ozbiljnost bolesti: bolesnici s PAH-om razvrstanim u razred II. imaju neznatno ograničenje fizičke aktivnosti, dok oni čija je bolest razvrstana u razred III. imaju značajno ograničenje fizičke aktivnosti.
English: Opsumit received a marketing authorisation valid throughout the EU on 20 December 2013.
Croatian: Lijek Opsumit dobio je odobrenje za stavljanje lijeka u promet koje je na snazi u Europskoj uniji od 20. prosinca 2013.
English: Opsumit can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in treating PAH.
Croatian: Opsumit se izdaje samo na liječnički recept, a liječenje mora započeti i nadzirati liječnik specijalist s iskustvom u liječenju PAH-a.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Opsumit have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Opsumit također se nalaze u sažetku opisa svojstava i u uputi o lijeku.
English: Opsumit contains the active substance macitentan.
Croatian: Opsumit sadržava djelatnu tvar macitentan.
English: PAH is a condition in which there is abnormally high blood pressure in the arteries of the lungs, causing symptoms such as breathlessness and fatigue.
Croatian: PAH je stanje s abnormalno visokim krvnim tlakom u plućnim arterijama koje uzrokuje simptome kao što su nedostatak daha i umor.
English: Opsumit can be used alone or in combination with other PAH medicines; for further information, see the package leaflet.
Croatian: Opsumit se može koristiti samostalno ili u kombinaciji s drugim lijekovima protiv PAH-a; dodatne informacije potražite u uputi o lijeku.
English: The company that markets Opsumit will send educational material to patients and healthcare professionals with information on the precautions to be taken when using Opsumit.
Croatian: Tvrtka koja na tržište stavlja lijek Opsumit bolesnicima i zdravstvenim radnicima poslat će edukativni materijal s informacijama o mjerama opreza potrebnim pri primjeni lijeka Opsumit.
English: Opsumit must therefore not be used in pregnant or breastfeeding women or in women who could become pregnant and who are not using reliable contraception.
Croatian: Opsumit se stoga ne smije upotrebljavati u trudnica, dojilja ili žena koje mogu zatrudnjeti i koje ne primjenjuju pouzdanu kontracepciju.
English: However, as animal studies showed an adverse effect on the development of embryos, Opsumit must never be used in pregnant women or women who could become pregnant and are not using reliable contraception.
Croatian: No, budući da je u ispitivanjima na životinjama otkriven štetan učinak na razvoj embrija, Opsumit se nikada ne smije primjenjivati u trudnica ili žena koje bi mogle zatrudnjeti i ne koriste pouzdanu kontracepciju.
English: Patients' reminder cards will include a warning that the medicine must never be used in pregnant women and that women who could become pregnant must be using reliable contraception and should undergo monthly pregnancy tests.
Croatian: Kartice s podsjetnikom za bolesnike sadržavat će upozorenje da se lijek nikada ne smije primjenjivati u trudnica te da žene koje bi mogle zatrudnjeti moraju koristiti pouzdanu metodu kontracepcije i raditi testove na trudnoću svakog mjeseca.
English: Opsumit is used for adults whose PAH is classified as WHO functional class II to class III.
Croatian: Opsumit se koristi u odraslih bolesnika čiji je PAH označen kao bolest funkcionalnog razreda II. do III. prema klasifikaciji Svjetske zdravstvene organizacije.
English: For more information about using Opsumit, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Opsumit pročitajte u uputi o lijeku, odnosno obratite se svojem liječniku ili ljekarniku.
English: Opsumit has been shown to be effective in reducing illness or deaths due to PAH and the side effects reported are similar to those reported with other medicines of its class and are considered to be manageable.
Croatian: Pokazalo se da je Opsumit djelotvoran u smanjenju bolesti ili smrtnih slučajeva povezanih s PAH-om, a zabilježene nuspojave slične su nuspojavama drugih lijekova iz njegova razreda te se smatraju prihvatljivima.
English: The active substance in Opsumit, macitentan, works by blocking endothelin receptors.
Croatian: Djelatna tvar u lijeku Opsumit, macitentan, djeluje inhibirajući endotelinske receptore.
English: Patients in the study received either Opsumit or placebo (a dummy treatment) in addition to other PAH treatments for an average of 2 years.
Croatian: Bolesnici koji su sudjelovali u ispitivanju primali su Opsumit ili placebo (prividni lijek) uz druge lijekove protiv PAH-a u prosjeku 2 godine.
English: In patients with PAH, this mechanism is overactive and, by blocking these receptors, macitentan helps widen the arteries in the lungs and thereby bring down the blood pressure.
Croatian: U bolesnika s plućnom arterijskom hipertenzijom taj je mehanizam prekomjerno aktivan, a inhibirajući navedene receptore Macitentan pomaže u proširenju plućnih arterija te snižava krvni tlak.
English: In PAH there is severe narrowing of the arteries of the lungs.
Croatian: PAH uzrokuje ozbiljno suženje plućnih arterija.
English: PAH is ‘rare', and Opsumit was designated an ‘orphan medicine' (a medicine used in rare diseases) for PAH on 27 September 2011.
Croatian: Plućna arterijska hipertenzija (PAH) rijetka je bolest, a Opsumit je dobio status lijeka za rijetku bolest PAH 27. rujna 2011.
English: Most side effects are mild to moderate in severity.
Croatian: Većina nuspojava blaga je do umjerena.
English: What benefits of Opsumit have been shown in studies?
Croatian: Koje su koristi lijeka Opsumit utvrđene u ispitivanjima?
English: How does Opsumit work?
Croatian: Kako djeluje Opsumit?
English: How is Opsumit used?
Croatian: Kako se Opsumit primjenjuje?
English: For the full list of side effects reported with Opsumit, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Opsumit potražite u uputi o lijeku.
English: When exposed to any of these viruses later in life, the cat will either not become infected or have a much less serious infection.
Croatian: Kada postane izložena tim virusima kasnije u životu, mačka ili neće postati zaražena ili će imati mnogo manje ozbiljnu infekciju.
English: In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to the viruses or bacteria.
Croatian: Ubuduće će imunosni sustav moći brže proizvoditi protutijela ako je izloženo stvarnim virusima ili bakterijama.
English: When a cat is given the vaccine, the immune system recognises the weakened or killed viruses and the weakened bacteria as ‘foreign' and makes antibodies against them.
Croatian: Kad mačka primi cjepivo, imunosni sustav prepoznaje oslabljene ili ubijene viruse kao „strano tijelo” i proizvodi protutijela na njih.
English: It was not possible to detect a rise in antibodies against C. felis because of high levels of antibodies in the cats at the beginning of the study.
Croatian: Nije bilo moguće detektirati porast protutijela protivC. felis zbog visokih razina protutijela u mačaka na početku ispitivanja.
English: The main measure of effectiveness was the level of antibodies in the blood against the viruses and bacteria in the vaccine.
Croatian: Glavna mjera učinkovitosti bila je koncentracija protutijela u krvi naspram virusa i bakterija u cjepivu.
English: If self-injection does occur in these people, tell the doctor that self-injection with a living chlamydial vaccine has occurred.
Croatian: Ako se samoinjektiranje dogodi kod tih osoba, recite liječniku da se dogodilo samoinjektiranje živim klamidijalnim cjepivom.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax RCPCh exceed the risks for the approved indications and recommended that Purevax RCPCh be given a marketing authorisation.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) zaključio je da koristi cjepiva Purevax RCPCh premašuju rizike za odobrene indikacije i preporučio je izdavanje odobrenja za stavljanje u promet cjepiva Purevax RCPCh.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RCPCh on 23 February 2005.
Croatian: Europska komisija izdala je odobrenje za stavljanje VMP-a Purevax RCPCh u promet koje je na snazi u Europskoj uniji od 23. veljače 2005.
English: Purevax RCPCh should not be used in pregnant cats.
Croatian: Purevax RCPCh ne smije se primjenjivati u gravidnih mačaka.
English: The cat should be revaccinated for all components one year after the first vaccination course, then every year for chlamydiosis, and every three years for rhinotracheitis, calicivirosis and panleucopenia.
Croatian: Mačku treba ponovno cijepiti za sve bolesti godinu dana nakon prvog cijepljenja, a potom svake godine za klamidiozu te svake tri godine za rinotraheitis, kalicivirozu i panleukopeniju.
English: Purevax RCPCh is used to vaccinate cats from the age of 8 weeks against the following diseases:
Croatian: Purevax RCPCh se koristi za cijepljenje mačaka u dobi od 8 tjedana nadalje protiv sljedećih bolesti:
English: • inactivated (killed) calicivirosis antigens (FCV 431 and G1 strains),
Croatian: • inaktivirane (mrtve) antigene kaliciviroze (sojeve FCV 431 i G1).
English: The antibodies will help to protect against the diseases caused by these viruses or bacteria.
Croatian: To pomaže u zaštiti od bolesti koje uzrokuju virusi ili bakterije.