FrancophonIA/ELRC3.0 huggingface dataset:
English: What measures are being taken to ensure the safe and effective use of Trulicity?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Trulicity?
English: Patients inject the medicine themselves (after suitable training) under the skin in the abdomen or thigh.
Croatian: Bolesnici sami ubrizgavaju lijek (nakon primjerene obuke) potkožno u abdomen ili bedro.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Trulicity's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Trulicity nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: The benefits of Trulicity have been studied in 5 main studies involving over 4,500 patients with type 2 diabetes.
Croatian: Koristi lijeka Trulicity ispitane su u 5 glavnih ispitivanja koja su obuhvatila više od 4 500 bolesnika s dijabetesom tipa 2.
English: The most common side effects with Trulicity (which may affect more than 1 in 10 people) are nausea (feeling sick), vomiting and diarrhoea.
Croatian: Najčešće nuspojave lijeka Trulicity (mogu se javiti u više od 1 na 10 osoba) su mučnina (osjećaj slabosti), povraćanje i proljev.
English: A risk management plan has been developed to ensure that Trulicity is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Trulicity.
English: The Committee noted that the medicine produces a significant and clinically relevant effect in controlling blood glucose when used with other medicines.
Croatian: Odbor je zaključio da lijek ima značajan i klinički relevantan utjecaj na kontroliranje razina glukoze u krvi ako se koristi s drugim lijekovima.
English: This was considered to be clinically meaningful and there was evidence that the benefits were maintained during long-term treatment.
Croatian: Zaključeno je da je ovo klinički značajno smanjenje, te da postoji dokaz da su koristi održane tijekom dugotrajnog liječenja.
English: What is Trulicity and what is it used for?
Croatian: Što je Trulicity i za što se koristi?
English: The patients' average HbA1c at baseline ranged from 7.6 to 8.5% and patients were treated for at least 52 weeks.
Croatian: Prosječna razina HbA1c u bolesnika na početku liječenja bila je u rasponu od 7,6 do 8,5 %, a bolesnici su liječeni najmanje 52 tjedna.
English: The active substance in Trulicity, dulaglutide, is a ‘GLP-1 receptor agonist'.
Croatian: Djelatna tvar lijeka Trulicity, dulaglutid, je „agonist GLP-1 receptora”.
English: HbA1c gives an indication of how well the blood glucose is controlled.
Croatian: HbA1c ukazuje na to koliko se dobro kontrolira razina glukoze u krvi.
English: 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: Glavno mjerilo djelotvornosti bila je promjena u razini glikoziliranog hemoglobina (HbA1c), što predstavlja postotak hemoglobina u krvi na koji se vezuje glukoza.
English: What are the risks associated with Trulicity?
Croatian: Koji su rizici povezani s lijekom Trulicity?
English: When Trulicity is injected, dulaglutide reaches the receptors in the pancreas and activates them.
Croatian: Prilikom ubrizgavanja lijeka Trulicity, dulaglutid dolazi do receptora u gušterači i aktivira ih.
English: It works by attaching to receptors for a substance called glucagon-like peptide 1 (GLP-1), which are found on the surface of the cells in the pancreas and stimulate them to release insulin.
Croatian: Djeluje vezujući se na receptore za djelatnu tvar peptid-1 nalik glukagonu (GLP-1), koji se nalaze na površini stanica u gušterači i stimuliraju ih za otpuštanje hormona.
English: Trulicity is available as prefilled pens (0.75 mg and 1.5 mg) containing a solution to be injected under the skin.
Croatian: Trulicity je dostupan u napunjenim brizgalicama (0,75 mg i 1,5 mg) koje sadrže otopinu za potkožno ubrizgavanje.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Trulicity, 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 Trulicity nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: However, when used alone in patients who cannot take metformin, or when used in very elderly patients (aged over 75), the ratio of benefit to risk was greatest at the lower dose.
Croatian: No, ako se koristio kao monoterapija u bolesnika koji ne mogu uzimati metformin, ili ako se koristio u vrlo starih bolesnika (starijih od 75 godina), omjer koristi i rizika bio je najveći u manjoj dozi.
English: After 26 weeks of treatment, Trulicity reduced HbA1c by between 0.71 and 1.59 percentage points at the lower dose, and by between 0.78 and 1.64 percentage points at the higher dose.
Croatian: Nakon 26 tjedana liječenja, lijek Trulicity smanjio je vrijednosti HbA1c za između 0,71 i 1,59 postotnih bodova u manjoj dozi, te između 0,78 i 1,64 postotnih bodova u većoj dozi.
English: About 51% of those given the lower dose and 60% of patients given the higher dose of Trulicity achieved a target HbA1c below 7.0% and this was generally more than the proportion achieving this target with alternative treatments.
Croatian: Otprilike 51 % bolesnika koji su primili manju dozu i 60 % bolesnika koji su primili veću dozu lijeka Trulicity postiglo je ciljanu vrijednost HbA1c manju od 7,0 %, a to je bilo načelno više u odnosu na udio koji je postigao ovu ciljanu vrijednost s alternativnim terapijama.
English: Trulicity was more effective than metformin at reducing HbA1c levels when used alone, and was more effective than the diabetes medicines exenatide (given twice daily) or sitagliptin, and at least as good as insulin glargine, when used as add-on to other treatments.
Croatian: Trulicity je bio djelotvorniji od metformina u snižavanju razina HbA1c u slučajevima kada se koristio kao monoterapija, te je bio djelotvorniji od lijeka dijabetesa eksenatida (koji se primjenjivao dva puta dnevno) ili sitagliptina, te je bio barem podjednako dobar kao inzulin glargin kada se koristio kao dodatak drugim terapijama.
English: Trulicity contains the active substance dulaglutide.
Croatian: Trulicity sadrži djelatnu tvar dulaglutid.
English: The medicine was more effective at weekly doses of 1.5 mg than 0.75 mg.
Croatian: Lijek je bio djelotvorniji u tjednim dozama od 1,5 mg nego od
English: It can also be used as an ‘add-on' to other diabetes medicines, including insulin, when these medicines together with exercise and diet are not providing adequate control of blood glucose.
Croatian: Može se također koristiti kao dodatak drugim lijekovima protiv dijabetesa, uključujući i inzulin, kada ti lijekovi zajedno s tjelovježbom i odgovarajućom prehranom ne pružaju primjerenu kontrolu razina glukoze u krvi.
English: The recommended dose is 0.75 mg injected once a week when used on its own, and 1.5 mg once a week in combination with other diabetes medicines (although doctors may begin with the lower dose in patients at potentially greater risk such as those aged over 75).
Croatian: Preporučena doza je 0,75 mg ubrizgana jednom tjedno ako se lijek koristi kao monoterapija, te 1,5 mg jednom tjedno u kombinaciji s drugim lijekovima protiv dijabetesa (iako liječnici mogu početi s manjom dozom
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: Dijabetes tipa 2 je bolest kod koje gušterača ne luči dovoljno inzulina za potrebe kontrole razine u krvi ili kada tijelo ne može učinkovito iskoristiti inzulin.
English: In these studies Trulicity was compared with placebo (a dummy treatment) or with other diabetes medicines when used alone or as an add-on to various combination treatments.
Croatian: U tim ispitivanjima lijek Trulicity uspoređen je s placebom (prividnim liječenjem) ili s drugim lijekovima protiv dijabetesa ako se koristi kao monoterapija ili kao dodatak raznim kombiniranim liječenjima.
English: Trulicity is a diabetes medicine used in adults with type 2 diabetes to control their blood glucose (sugar) level.
Croatian: Trulicity je lijek protiv šećerne bolesti koji se koristi za liječenje odraslih osoba s dijabetesom tipa 2 za kontroliranje razina glukoze (šećera) u krvi.
English: This causes the release of insulin and helps to reduce blood glucose levels and control type 2 diabetes.
Croatian: To uzrokuje otpuštanje inzulina i pomaže u snižavanju razina glukoze u krvi te kontroli dijabetesa tipa 2.
English: For more information about treatment with Trulicity, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Trulicity pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: How does Trulicity work?
Croatian: Kako djeluje Trulicity?
English: Trulicity can be used on its own in patients whose blood glucose levels are not satisfactorily controlled on diet and exercise alone and who cannot take metformin (another diabetes medicine).
Croatian: Trulicity se može koristiti kao monoterapija u bolesnika čije se razine glukoze ne mogu zadovoljavajuće kontrolirati prehranom i tjelovježbom te koji ne mogu uzimati metformin (drugi lijek protiv dijabetesa).
English: What benefits of Trulicity have been shown in studies?
Croatian: Koje su koristi lijeka Trulicity utvrđene u ispitivanjima?
English: For the full list of all side effects and restrictions with Trulicity, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Trulicity potražite u uputi o lijeku.
English: For practical information about using Trulicity, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Trulicity pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: How is Trulicity used?
Croatian: Kako se Trulicity koristi?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom with a type of diabetes medicine called a sulphonylurea or with insulin, the dose of the sulphonylurea or insulin may need to be lowered to avoid hypoglycaemia (low blood sugar levels).
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom u bolesnika koji su potencijalno izloženi većem riziku poput primjerice onih starijih od 75 godina).
English: 340 ml (0.5 mg/ml) 1 bottle + 2 syringes + 1 bottle adapter
Croatian: 1 boca + 2 štrcaljke + 1 nastavak za bočicu
English: Oral suspension Oral use bottle (PET)
Croatian: Oralna suspenzija
English: Outcome of re-examination of procedure under Article 29(4) of Directive 2001/83/EC
Croatian: Ishod postupka preispitivanja u skladu s člankom 29. stavkom 4. Direktive 2001/83/EZ
English: Risk minimisation measures were proposed for the known risks.
Croatian: Mjere za smanjenje rizika predložene su za poznate rizike.
English: The company requested a re-examination of the initial opinion.
Croatian: Tvrtka je zatražila preispitivanje prvotnog mišljenja.
English: Alcover syrup is available in Austria and Italy.
Croatian: Sirup Alcover dostupan je u Austriji i Italiji.
English: (the ‘concerned Member States', in this instance Denmark, Finland, France, Ireland, the Netherlands, Poland, Portugal, Spain, Sweden and the United Kingdom).
Croatian: državama članicama („predmetne države članice”, u ovom slučaju Danska, Finska, Francuska, Irska, Nizozemska, Poljska, Portugal, Španjolska, Švedska i Ujedinjena Kraljevina).
English: What are Alcover granules?
Croatian: Što su granule Alcover?
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Austria) assesses a medicine with a view to granting a marketing authorisation that will be valid nationally as well as in other Member States
Croatian: To je postupak u kojem jedna država članica („referentna država članica”, u ovom slučaju Austrija) ocjenjuje lijek radi izdavanja odobrenja za njegovo stavljanje u promet koje će biti valjano u toj državi i u drugim
English: Why were Alcover granules reviewed?
Croatian: Zašto su granule Alcover ponovno ocjenjivane?
English: Debrégeas & Associés Pharma submitted a marketing authorisation application for Alcover granules to the Austrian medicines regulatory agency for a decentralised procedure.
Croatian: Tvrtka Debrégeas & Associés Pharma podnijela je zahtjev za odobrenje za stavljanje u promet za granule Alcover regulatornoj agenciji za lijekove Austrije za decentralizirani postupak.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Alcover granules did not outweigh their risks, and the marketing authorisation could not be granted in Austria or in the following Member States of the EU: Denmark, Finland, France, Ireland, the Netherlands, Poland, Portugal, Spain, Sweden and the United Kingdom.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je da koristi od granula Alcover ne nadmašuju s njima povezane rizike te da se ne može izdati odobrenje za stavljanje lijeka u promet u Austriji ili u sljedećim državama članicama EU-a: Danskoj, Finskoj, Francuskoj, Irskoj, Nizozemskoj, Poljskoj, Portugalu, Španjolskoj, Švedskoj i Ujedinjenoj Kraljevini.
English: However, the Member States were not able to reach an agreement and the Austrian medicines regulatory agency referred the matter to the CHMP for arbitration on 22 December 2016.
Croatian: Međutim, države članice nisu mogle postići dogovor pa je regulatorna agencija za lijekove Austrije uputila predmet CHMP-u na arbitražni postupak 22. prosinca 2016.
English: On 22 June 2017, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of Alcover granules.
Croatian: Europska agencija za lijekove završila je 22. lipnja 2017. arbitražni postupak koji je pokrenut zbog neslaganja među državama članicama Europske unije (EU) u vezi s odobrenjem za granule Alcover.
English: Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg)
Croatian: Pitanja i odgovori o granulama Alcover (natrijev oksibat 750, 1250 i 1750 mg)
English: The active substance in Alcover granules, sodium oxybate, attaches to receptors (targets) on nerve cells of the brain and spinal cord for a substance called gammaaminobutyric acid (GABA), leading to a calming of the activity of these cells.
Croatian: Djelatna tvar u granulama Alcover natrijev oksibat veže se za receptore (mete) na živčanim stanicama mozga i leđnoj moždini, odnosno za tvar koja se naziva gama-aminobutirična kiselina (GABA), što dovodi do smirivanja aktivnosti tih stanica.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the data submitted in support of the marketing authorisation application for Alcover granules were insufficient and of inadequate quality to demonstrate that the medicine would be effective in the proposed uses.
Croatian: Na temelju procjene trenutačno dostupnih podataka i znanstvene rasprave u Odboru, CHMP je zaključio da podatci koji su podneseni uz zahtjev za odobrenje za stavljanje u promet granula Alcover nisu dovoljni i da nisu odgovarajuće kvalitete za utvrđivanje djelotvornosti lijeka za predložene uporabe.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 18/12/2017.
Croatian: Mišljenje CHMP-a proslijeđeno je Europskoj komisiji koja je 18/12/2017. donijela konačnu, pravno obvezujuću odluku koja se primjenjuje u svim državama članicama EU-a.
English: Since it targets these receptors in the same way as alcohol, Alcover granules were to be used to treat the effects of stopping alcohol use in alcohol-dependent patients, including agitation, tremor (shaking) and problems sleeping, and to support continued abstinence.
Croatian: Budući da ciljaju te receptore na isti način kao i alkohol, granule Alcover trebale su se koristiti za liječenje učinaka prestanka uzimanja alkohola u bolesnika koji su ovisni o alkoholu, odnosno uznemirenosti, tremora (drhtavica) i problema sa spavanjem, kao i za održavanje stalne apstinencije.
English: Alcover granules are a medicine that was expected to be used to treat acute alcohol withdrawal syndrome and to support medium to long-term abstinence in alcohol-dependent adults with a very high level of alcohol consumption.
Croatian: Granule Alcover su lijek koji se trebao upotrebljavati za liječenje sindroma akutnog odvikavanja od alkohola i za podupiranje srednjoročne do dugoročne apstinencije u odraslih osoba ovisnih o alkoholu koje konzumiraju alkohol u iznimno velikim količinama.
English: Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) EMA/833763/2017
Croatian: Pitanja i odgovori o granulama Alcover (natrijev oksibat 750, 1250 i 1750 mg) EMA/816779/2017
English: The grounds for the referral were concerns raised by several Member States that the benefits of Alcover granules were not clearly demonstrated and there were various risks including the risk of dependence, misuse and side effects.
Croatian: Razloge za arbitražni postupak prijavilo je nekoliko država članica jer koristi granula Alcover nisu jasno utvrđene i povezane su s različitim rizicima, uključujući rizik od ovisnosti, zloupotrebe i nuspojava.
English: After reviewing the grounds for this request, the CHMP re-examined the opinion and confirmed on 12 October 2017 that the marketing authorisation could not be granted.
Croatian: Nakon razmatranja razloga za ovaj zahtjev CHMP je preispitao prvotno mišljenje i potvrdio odbijanje izdavanja odobrenja za stavljanje lijeka u promet dana 12. listopada 2017.
English: After re-examination, the CHMP confirmed its initial opinion that the marketing authorisation could not be granted.
Croatian: Nakon preispitivanja, CHMP je potvrdio svoje prvotno mišljenje o odbijanju izdavanja odobrenja za stavljanje lijeka u promet.
English: However, the CHMP concluded that, since the benefits of Alcover granules were not clearly demonstrated, the marketing authorisation could not be granted in the reference and concerned Member States.
Croatian: Međutim, budući da koristi granula Alcover nisu jasno utvrđene, CHMP je zaključio da se ne može izdati odobrenje za stavljanje lijeka u promet za referentnu državu članicu i predmetne države članice.
English: This decision only concerns the marketing authorisation application for Alcover granules and does not affect Alcover syrup.
Croatian: Ta se odluka odnosi samo na zahtjev za odobrenje za stavljanje u promet granula Alcover.
English: Both are anti-hypertensive medicines that have been available separately in the European Union (EU) since the mid-1990s.
Croatian: Obje tvari su antihipertenzivi koji su zasebno dostupni u Europskoj uniji (EU) od sredine 1990.-ih.
English: The full EPAR for Imprida can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Imprida nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Imprida is taken by mouth as one tablet once a day with some water.
Croatian: Imprida se uzima peroralno kao jedna tableta jednom na dan s malo vode.
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 Imprida.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje za izdavanje odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima za primjenu lijeka Imprida.
English: The European Commission granted a marketing authorisation valid throughout the EU for Imprida on 17 January 2007.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Imprida na snazi u Europskoj uniji od 16. siječnja 2007.
English: Valsartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Croatian: Valsartan je „antagonista angiotenzin II receptora”, što znači da blokira djelovanje hormona u tijelu naziva angiotenzin II.
English: In all studies, the main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).
Croatian: Glavna mjera djelotvornosti u svim ispitivanjima bilo je snižavanje dijastoličkog krvnog tlaka (krvnog tlaka izmjerenog između dva otkucaja srca).
English: This is a summary of the European public assessment report (EPAR) for Imprida.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Imprida.
English: Other information about Imprida
Croatian: Ostale informacije o lijeku Imprida
English: For more information about treatment with Imprida, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Imprida pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: The fifth, smaller study compared the combination with lisinopril and hydrochlorothiazide (another combination used to treat hypertension) in 130 patients with severe hypertension.
Croatian: Peto, manje ispitivanje usporedilo je te kombinacije s lizinoprilom i hidroklorotiazidom (drugom kombinacijom koja se koristi za liječenje hipertenzije) u 130 bolesnika s ozbiljnom hipertenzijom.
English: By lowering the blood pressure, the risks associated with by high blood pressure, such as having a stroke, are reduced.
Croatian: Snižavanjem krvnog tlaka, smanjuju se i rizici povezani s visokim krvnim tlakom, poput primjerice moždanog udara.
English: What is the risk associated with Imprida?
Croatian: Koji su rizici povezani s lijekom Imprida?
English: The most common side effects with Imprida (seen in between 1 and 10 patients in 100) are headache, nasopharyngitis (inflammation of the nose and throat), influenza (flu), hypokalaemia (low blood potassium levels), various types of oedema (swelling), fatigue (tiredness), flushing (reddening), asthenia (weakness) and hot flushes.
Croatian: Najčešće nuspojave lijeka Imprida (koje se mogu javiti u 1 do 10 osoba na 100 osoba) su glavobolja, nazofaringitis (upala nosa i grla), influenca (gripa), hipokalemija (mala koncentracija kalija u krvi), različiti tipovi edema (oticanje), iscrpljenost (umor), rumenilo (crvenilo), astenija (slabost) i napadaji vrućine.
English: The company also presented evidence that the levels of amlodipine and valsartan in the blood were the same in people taking Imprida and people taking the separate medicines.
Croatian: Farmaceutska je tvrtka također dostavila dokaz da su koncentracije amlodipina i valsartana u krvi bile jednake u osoba koje su uzimale lijek Imprida i osoba koje su uzimale druge lijekove.
English: The CHMP decided that Imprida's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Imprida nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za stavljanje u promet.