FrancophonIA/ELRC3.0 huggingface dataset:
English: This compared with a reduction of 0.45 with linagliptin alone, 0.64 with 500 mg metformin alone, 1.07 with 1,000 mg metformin alone, and 0.13 with placebo.
Croatian: Za usporedbu, sniženje od 0,45 ostvareno je uz primjenu monoterapije linagliptinom, 0,64 pri monoterapiji u dozi od 500 mg metformina, 1,07 pri monoterapiji u dozi od 1 000 mg metformina i 0,13 s placebom.
English: The study with the combination of linagliptin and metformin showed that it was more effective than linagliptin or metformin alone, as well as placebo, at reducing HbA1c levels.
Croatian: Ispitivanje provedeno s kombiniranom terapijom linagliptina i metformina dokazalo je da je ova terapija djelotvornija od monoterapija linagliptinom ili metforminom, kao i placebom, u snižavanju razina hemoglobina HbA1c.
English: What is Jentadueto used for?
Croatian: Za što se Jentadueto koristi?
English: Another study carried out in 1040 patients with type 2 diabetes compared patients taking 5 mg linagliptin and insulin given with metformin, with patients taking placebo given with insulin and metformin.
Croatian: Drugo ispitivanje provedeno je na 1 040 bolesnika oboljelih od dijabetesa tipa 2, a usporedilo je bolesnike koji su uzimali linagliptin u dozi od 5 mg i inzulin s metforminom s bolesnicima koji su uzimali placebo zajedno s inzulinom i metforminom.
English: Another study was carried out involving 791 patients with type 2 diabetes, where the combination of linagliptin plus metformin given twice per day was compared with giving metformin alone, linagliptin alone or placebo.
Croatian: Drugo provedeno ispitivanje uključivalo je 791 bolesnika s dijabetesom tipa 2, a usporedilo je kombinaciju linagliptina i metformina koja se davala dvaput dnevno i monoterapiju metforminom, monoterapiju linagliptinom ili placebo.
English: • in patients who are not satisfactorily controlled on metformin (a diabetes medicine) used on its own;
Croatian: • u bolesnika kod kojih nije postignuta zadovoljavajuća kontrola stanja monoterapijom metforminom
English: How is Jentadueto used?
Croatian: Kako se Jentadueto koristi?
English: How has Jentadueto been studied?
Croatian: Kako je Jentadueto ispitivan?
English: How does Jentadueto work?
Croatian: Kako djeluje Jentadueto?
English: 9 September 2014 EMA/554928/2014
Croatian: 9. rujna 2014. EMA/554928/2014
English: Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/02/news_detail_001446.jsp&mid =WC0b01ac058004d5c1
Croatian: Dostupno na stranici: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/02/news_detail_001446.jsp&mid=WC 0b01ac058004d5c1
English: A review of these data was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Croatian: Pregled ovih podataka prvo je proveo Odbor za ocjenu rizika na području farmakovigilancije (PRAC).
English: The review of RAS-acting agents was initiated at the request of the Italian Medicines Agency (AIFA), under Article 31 of Directive 2001/83/EC.
Croatian: Pregled lijekova koji djeluju na RAS započet je na zahtjev Talijanske agencije za lijekove (AIFA), sukladno članku 31. Direktive 2001/83/EZ.
English: • In a small number of patients (mostly with heart failure) there may still be a medical need to combine two classes of these medicines.
Croatian: • U slučaju manjeg broja bolesnika (u većini slučajeva uslijed zatajenja srca), može još uvijek postojati medicinska potreba za kombiniranjem dvije klase ovih lijekova.
English: • Patients currently taking a combination of these medicines, or who have any concerns or questions, should discuss their medication with their doctor at their next regular appointment.
Croatian: • Bolesnici koji trenutno uzimaju kombinaciju ovih lijekova ili koji imaju bilo kakvih razloga za zabrinutost ili pitanja, trebaju sa svojim liječnikom razgovarati o svojoj terapiji pri sljedećoj redovitoj kontroli.
English: These recommendations are based on a detailed review of the available data, including clinical trials, meta-analyses and publications, as well as advice from a group of experts on cardiovascular medicine.
Croatian: Ove se preporuke temelje na detaljnom pregledu dostupnih podataka, uključujući klinička ispitivanja, meta analize i publikacije, ako i savjetu grupe stručnjaka za kardiovaskularnu medicine.
English: RAS-acting agents have been authorised in the European Union (EU) through central and national approval procedures and are widely available in the EU under a variety of trade names.
Croatian: Lijekovi koji djeluju na RAS odobreni su u Europskoj uniji (EU) putem središnjih i nacionalnih postupaka odobrenja i dostupni su širom EU-a pod različitim trgovačkim nazivima.
English: 1 European Medicines Agency recommends new contraindications and warnings for aliskiren-containing medicines.
Croatian: Europska agencija za lijekove preporučila je nove kontraindikacije i upozorenja za lijekove koji sadrže aliskiren.
English: They are used to treat conditions like high blood pressure or heart failure (when the heart cannot pump blood around the body as well as it should).
Croatian: Koriste se za liječenje stanja poput visokog krvnog tlaka ili srčanog zatajenja (u slučaju kada srce ne može kolati krv kroz tijelo u mjeri u kojoj je to potrebno).
English: As some RAS-acting agents have been centrally authorised, the PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's final opinion.
Croatian: Budući da su pojedini lijekovi koji djeluju na RAS središnje odobreni, preporuke PRAC-a dostavljene su Odboru za lijekove za humanu uporabu (CHMP), odgovornom za pitanja lijekova za primjenu kod ljudi, koje je usvojilo konačno mišljenje Agencije.
English: • Available efficacy data indicate that such dual blockade does not provide significant benefit in the general patient population, although some selected patient sub-populations may possibly benefit.
Croatian: • Dostupni podaci o djelotvornosti ukazuju da ovakvi dualni inhibitori ne pružaju značajnu korist općoj populaciji bolesnika, iako bi određene podpopulacije bolesnika mogle imati koristi.
English: In patients with heart failure there is some evidence that the addition of a second RAS-acting agent may reduce hospital admissions.
Croatian: U bolesnika sa zatajenjem srca, postoje određeni dokazi da dodatak drugog lijeka koji djeluje na RAS može smanjiti broj hospitalizacija.
English: This is of particular concern, as these patients and patients with renal impairment are already prone to developing hyperkalaemia.
Croatian: Ovo je poseban razlog za zabrinutost budući da su ovi bolesnici i bolesnici s oštećenjem bubrega već skloni razvoju hiperkalemije.
English: The CHMP opinion was then forwarded to the European Commission, which confirmed it and issued final decisions, valid throughout the EU, on 4 and 9 September 2014.
Croatian: Mišljenje CHMP-a zatim je prosljeđeno Europskoj komisiji, koja ga je potvrdila i usvojila kao svoju konačnu odluku valjanu na razini EU-a dana 4. i 9. rujna 2014.
English: This broad review of evidence relating to all RAS-acting agents supported the conclusions of a previous EMA review relating specifically to medicines containing aliskiren.1
Croatian: Ovaj širok pregled dokaza povezanih sa svim lijekovima koji djeluju na RAS govori u prilog zaključcima prethodnog pregleda provedenog od strane EMA-e vezanog izričito uz lijekove koji sadrže aliskiren.1
English: • Combining RAS-acting agents is therefore no longer recommended.
Croatian: • Kombiniranje lijekova koji djeluju na RAS se stoga više ne preporučuje.
English: • RAS-acting agents are medicines acting on a hormone system that helps to control blood pressure and the amount of fluid in the body.
Croatian: • Lijekovi koji djeluju na RAS su lijekovi koji djeluju na hormonski sustav koji pomaže u kontroliranju krvnoga tlaka i količine tekućine u tijelu.
English: The CHMP opinion confirmed recommendations made by the Agency's Pharmacovigilance Risk Assessment Committee (PRAC) in April 2014, following assessment of evidence from several large studies in patients with various pre-existing heart and circulatory disorders, or with type 2 diabetes.
Croatian: Mišljenje CHMP-a potvrđeno je preporukama koje je iznio Odbor za ocjenu rizika na području farmakovigilancije (PRAC) pri Agenciji u travnju 2014. po provedenom pregledu dokaza dostupnih iz nekoliko velikih ispitivanja provedenih u bolesnika s različitim postojećim poremećajima srca i cirkulacije ili s dijabetesom tipa
English: On 23 May 2014 the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) endorsed restrictions on combining different classes of medicines that act on the reninangiotensin system (RAS), a hormone system that controls blood pressure and the volume of fluids in the body.
Croatian: Dana 23. svibnja 2014., Odbor za lijekove za humanu uporabu (CHMP) pri Europskoj agenciji za lijekove potvrdilo je ograničenja vezana uz kombiniranje različitih kategorija lijekova koji djelujuju na renin-angiotenski sustav (RAS), hormonski sustav koji regulira omjer krvnog tlaka i tekućine u tijelu.
English: Furthermore, no significant benefits from dual blockade were seen in patients without heart failure and benefits were thought to outweigh risk only in a selected group of patients with heart failure in whom other treatments were unsuitable.
Croatian: Nadalje, druge značajne koristi primjene dualne inhibicije nisu uočene u bolesnika bez srčanog zastoja te je smatrano da koristi nadmašuju rizik samo u odabranoj grupi bolesnika s zatajenjem srca u kojih druge vrste terapija nisu smatrane primjerenima.
English: Blocking the action of this hormone allows blood vessels to widen and helps to reduce the amount of water reabsorbed by the kidneys, thereby reducing blood pressure in the body.
Croatian: Inhibirajući djelovanje ovog hormona omogućuje se širenje krvnim žilama i pomaže se pri smanjivanju količine vode koju bubrezi ponovno apsorbiraju, te se stoga smanjuje krvni tlak u tijelu.
English: However, a review of the latest evidence has suggested that in most patients such combination does not increase the benefits, and may increase the risks of low blood pressure, increased potassium in the blood and possible damage to the kidney.
Croatian: No, na temelju pregleda posljednjeg dokaza donijet je zaključak da u slučaju većine bolesnika takva kombinacija ne povećava koristi, te da može povećati rizik od krvnog tlaka, povisiti razinu natrija u krvi i uzrokovati moguće oštećenje bubrega.
English: However, in patients with chronic heart failure, dual blockade should be limited to those intolerant to mineralocorticoid antagonists and with persistent symptoms despite other optimal therapy.
Croatian: No, u bolesnika s kroničnim zatajenjem srca, dvostruke blokade treba ograničiti na mineralokortikoidne antagoniste te u slučaju simptoma koji se ne mogu ukloniti usprkos optimalnoj terapiji.
English: The CHMP opinion was forwarded to the European Commission, which issued final decisions valid throughout the EU in September 2014.
Croatian: Mišljenje CHMP-a prosljeđeno je Europskoj komisiji, koja je usvojila zaključnu odluku primjenjivu na razini EU-a u rujnu 2014.
English: Restriction of combined use of medicines affecting the renin-angiotensin system (RAS)
Croatian: Ograničenje u kombiniranoj primjeni lijekova koji utječu na renin-angiotenski sustav (RAS)
English: RAS-acting agents work by blocking different stages of the renin-angiotensin system (RAS).
Croatian: Lijekovi koji djeluju na RAS blokiraju različite faze renin-angiotenskog sustava (RAS).
English: • RAS-acting agents from two different classes have sometimes been combined for an increased effect.
Croatian: • U pojedinim slučajevima kombinirani su lijekovi koji djeluju na RAS iz dvije različite kategorije sa ciljem povećavanja učinka.
English: ACE-inhibitors (benazepril, captopril, cilazapril, delapril, enalapril, fosinopril, imidapril, lisinopril, moexipril, perindopril, quinapril, ramipril, spirapril, trandolapril or zofenopril) and the direct renin inhibitor aliskiren block the actions of specific enzymes involved in the production of angiotensin II in the body (ACE-inhibitors block angiotensin-converting enzyme, while renin inhibitors block an enzyme called renin).
Croatian: Inhibitori ACE-a (benazepril, captopril, cilazapril, delapril, enalapril, fosinopril, imidapril, lisinopril, moexipril, perindopril, quinapril, ramipril, spirapril, trandolapril ili zofenopril) i izravan inhibitor renina aliskiren inhibiraju djelovanje specifičnih enzima uključenih u stvaranje angiotenzina II u tijelu (inhibitori ACE-a inhibiraju enzim koji konventira angiotenzin, dok inhibitori renina inhibiraju enzim naziva renin).
English: ARBs (containing the active substances azilsartan, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan or valsartan) block receptors for a hormone called angiotensin II.
Croatian: ARB-ovi (koji sadrže djelatne tvari poput azilsartana, kandesartana, eprosartana, irbesartana, losartana, olmesartana, telmisartana ili valsartana) inhibiraju receptore za hormone naziva angiotensin II.
English: The product information for all RAS-acting agents has been amended accordingly.
Croatian: Informacije o proizvodu za sve lijekove koji sadrže RAS su primjereno dopunjene.
English: These medicines (called RAS-acting agents) belong to three main classes: angiotensin-receptor blockers (ARBs, sometimes known as sartans), angiotensin-converting enzyme inhibitors (ACEinhibitors) and direct renin inhibitors such as aliskiren.
Croatian: Ovi lijekovi (naziva lijekovi koji djeluju na RAS) ubrajaju se u tri različite klase: blokatori receptora angiotenzina (ARB-ovi, koji se ponekad nazivaju sartani), inhibitore enzima, koji konvertiraju angiotenzin (inhibitore ACE-a) i izravni inhibitori renina, poput aliskirena.
English: doi: 10.1136/bmj.f360.
Croatian: BMJ. 2013; 346: f360. doi: 10.1136/bmj.f360.
English: This would include the licensed use of the ARBs candesartan or valsartan as addon therapy to ACE-inhibitors in patients with heart failure who require such a combination.
Croatian: Ovo bi uključivalo odobrenu primjenu ARB-ova kandesartana ili valsartana kao dodatne terapije uz inhibitore ACE-a u bolesnika sa zatajenjem srca, a u kojih je potrebna takva kombinacija.
English: These medicines can be of three different classes known as ARBs, ACE inhibitors and direct renin inhibitors (the last represented by the medicine aliskiren).
Croatian: Ovi lijekovi mogu dolaziti iz tri različite klase poznate pod nazivima ARB-ovi, inhibitori ACE-a i izravni inhibitori renina (pri čemu potonje najbolje predstavlja lijek aliskiren).
English: The combination of aliskiren with an ARB or ACE-inhibitor is strictly contraindicated in those with kidney impairment or diabetes.
Croatian: Kombinacija aliskirena s ARB-om ili inhibitorom ACE-a najstrože je kontraindicirana u bolesnika s oštećenjem bubrega ili dijabetesom.
English: • In individual cases where combined use of an ARB and ACE inhibitor is considered absolutely essential, it must be carried out under specialist supervision with close monitoring of renal function, electrolytes and blood pressure.
Croatian: • U pojedinim slučajevima kada se kombinirana primjena ARB-a i inhibitora ACE-a smatra apsolutno neophodnom, ista se mora provesti pod nadzorom specijaliste uz strogo praćenje funkcije bubrega, elektrolita i krvnoga tlaka.
English: These studies found that combination of an ARB with an ACE-inhibitor was associated with an increased risk of hyperkalaemia (increased potassium in the blood), kidney damage or low blood pressure compared with using either medicine alone.
Croatian: Ovim je ispitivanjima utvrđeno da je kombinacija ARB-a s inhibitorom ACE-a povezana s povišenim rizikom od hiperkalemije (povećana količina natrija u krvi), oštećenjem bubrega ili niskim krvnim tlakom u usporedbi s monoterapijom bilo kojim drugim lijekom.
English: • Such supervised use would include the licensed use of candesartan or valsartan as add-on therapy to ACE inhibitors in patients with heart failure.
Croatian: • Takva kontrolirana primjena uključivala bi odobrenu primjenu kandesartana ili valsartana kao dodatne terapije uz inhibitore ACE-a u bolesnika sa zatajenjem srca.
English: • On the basis of current evidence, dual RAS blockade therapy through the combined use of ACEinhibitors, ARBs or aliskiren is not recommended in any patient.
Croatian: • Na temelju trenutno dostupnih dokaza, ne preporuča se terapija dualnom inhibicijom RAS-a koja se provodi kombiniranom primjenom inhibitora ACE-a, ARB-ova ili aliskirena u slučaju bilo kojih bolesnika.
English: In particular, ACE-inhibitors and ARBs should not be used concomitantly in patients with diabetic nephropathy, and existing contraindications on the use of aliskiren with either an ARB or an ACE inhibitor in patients with diabetes mellitus or moderate to severe renal impairment (GFR < 60 ml/min/1.73 m2) are confirmed.
Croatian: Inhibitori ACE-a i ARB-ovi ne smiju se, posebice, istovremeno koristiti u bolesnika s dijabetičkom nefropatijom, te su potvrđene postojeće kontraindikacije za promjenu aliskirena bilo s ARB-om ili inhibitorom ACE-a u bolesnika s dijabetesom melitusom ili umjerenim do ozbiljnim oštećenjem bubrega (GFR < 60 ml/min/1.73 m2).
English: When this is considered absolutely necessary, it will be carried out under specialist supervision with close monitoring of kidney function, fluid and salt balance and blood pressure.
Croatian: Ukoliko se ovo smatra u potpunosti neophodnim, isto će se provesti uz nadzor specijaliste uz strogo praćenje funkcije bubrega, omjera tekućine i soli te krvnoga tlaka.
English: • There is considerable evidence from large clinical trials such as ONTARGET1, ALTITUDE2 and VA NEPHRON-D3 and from meta-analyses such as that of Makani4 (involving over 68,000 patients) demonstrating that dual RAS blockade through the combined use of ACE-inhibitors, ARBs or aliskiren is associated with an increased risk of adverse events, including hypotension, hyperkalaemia and renal failure compared with monotherapy, in particular in patients with diabetic nephropathy.
Croatian: NEPHRON-D3 te iz meta analiza poput Makani4 (obuhvaćajući 68.000 bolesnika) koji dokazuje da je dualna terapija blokade RAS-a putem kombinirane primjene inhibitora ACE-a, inhibitora ARB-ova ili aliskirena povezana s povećanim rizikom od nuspojava, uključujući hipotenziju, hiperkalemiju i zatajenje bubrega u usporedbi s monoterapijom, posebice u bolesnika s dijabetičkom nefropatijom.
English: Combination of medicines from any two of these classes is not recommended and, in particular, patients with diabetes-related kidney problems (diabetic nephropathy) should not be given an ARB with an ACE-inhibitor.
Croatian: Ne preporuča se kombiniranje lijekova iz bilo koje dvije prethodno navedene klase, a posebice, se ARB u kombinaciji s inhibitorom ACE-a ne smije primjenjivati u bolesnika s oštećenjem bubrega povezanim s dijabetesom (s dijabetičkom nefropatijom).
English: Makani H, Bangalore S, Desouza KA, et al. Efficacy and safety of dual blockade of the reninangiotensin system: meta-analysis of randomised trials.
Croatian: Efficacy and safety of dual blockade of the reninangiotensin system: meta-analysis of randomised trials.
English: In particular, patients who have kidney problems related to diabetes should not be given an ARB with an ACE inhibitor (use of either of these types of medicine with aliskiren is already prohibited in patients with diabetes or kidney problems).
Croatian: ARB s inhibitorom ACE-a se posebice ne smije primjenjivati u bolesnika s oštećenjem bubrega povezanim s dijabetesom (primjena bilo kojeg tipa ovih lijekova s aliskirenom već je zabranjena u bolesnika s dijabetesom ili oštećenjem bubrega).
English: Where combination of these medicines (dual blockade) is considered absolutely necessary, it must be carried out under specialist supervision with close monitoring of kidney function, fluid and salt balance and blood pressure.
Croatian: U slučaju kada se kombinacija ovih lijekova (dvostruka inhibicija) smatra potpuno neophodnom, ista mora nastupiti samo pod specijalističkim nadzorom i predmetom je učestalog praćenja funkcije bubrega, omjera tekućine i soli te krvnoga tlaka.
English: • The existing contraindication on the concomitant use of ACE-inhibitors or ARBs with aliskirencontaining products in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2), which is based on the ALTITUDE study data, was confirmed in the light of the additional data reviewed.
Croatian: • Na temelju pregledanih dodatnih podataka potvrđena je postojeća kontraindikacija za istovremenu primjenu inhibitora ACE-a ili ARB-ova s lijekovima koji sadrže aliskiren u bolesnika s dijabetesom melitusom ili oštećenjem bubrega (GFR < 60 ml/min/1.73 m2), koja se temeljila na podacima ispitivanja ALTITUDE.
English: References.
Croatian: Literatura:
English: BMJ.
Croatian: N Engl J Med.
English: Do not use in horses less than 6 weeks of age.
Croatian: Ne koristite u konja koji su mlađi od 6 tjedana.
English: Maximal plasma concentrations are obtained after approximately 2-3 hours.
Croatian: Maksimalne koncentracije u plazmi su dobivene nakon 2-3 sata.
English: Elimination Meloxicam is eliminated with a terminal half-life of 7.7 hours.
Croatian: Eliminacija Meloksikam se eliminira s konačnim poluživotom od 7,7 sati.
English: Shake vigorously at least 20 times before use.
Croatian: Žustro protresite najmanje 20 puta prije primjene.
English: Water, purified
Croatian: Voda, pročišćena
English: Symptoms were reversible.
Croatian: Simptomi su reverzibilni.
English: The volume of distribution is 0.12 l/kg.
Croatian: Volumen distribucije iznosi 0,12 l/kg.
English: Pregnancy and lactation: See section “Contraindications”.
Croatian: Graviditet i laktacija:Vidi dio "Kontraindikacije",
English: When the product is used according to the recommended dosage regime the oral bioavailability is approximately 98 %.
Croatian: Ako se proizvod koristi u skladu s preporučenim režimom doziranja, bioraspoloživost iznosi otprilike 98%.
English: Meat and offal: 3 days.
Croatian: Meso i iznutrice 3 dana.
English: These measures should help to protect the environment.
Croatian: Ove će mjere pomoći u očuvanju okoliša.
English: The metabolism is qualitatively similar in rats, mini-pigs, humans, cattle and pigs although quantitatively there are differences.
Croatian: Metabolizam je kvalitativno sličan u štakora, mini svinja, ljudi, goveda i svinja, iako kvantitativno postoje razlike.
English: The active substance in Novaquin is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Croatian: Djelatna tvar Novaquina je dozvoljena tvar kako je opisano u tablici 1 Dodatka Uredbe Komisije (EU) br. 37/2010:
English: Therefore the use in this species is not recommended during pregnancy and lactation.
Croatian: Stoga se ne preporuča primjena u ove vrste tijekom graviditeta i laktacije.
English: Slovenská republika Sevaron ltd
Croatian: Česká republika Sevaron ltd
English: Avoid introduction of contamination during use.
Croatian: Izbjegavajte uvođenje kontaminacije tijekom primjene.
English: EXP (month/year) Once broached, use by ……….
Croatian: EXP {mjesec/godina} Jednom otvorenu, upotrijebiti do...
English: After administration of the veterinary medicinal product, close the bottle by replacing the cap, wash the measuring syringe with warm water and let it dry.
Croatian: Nakon primjene veterinarsko-medicinskog proizvoda zatvorite bočicu tako što ćete zamijeniti čep, operite mjernu štrcaljku toplom vodom i ostavite je da se osuši.
English: The syringe fits onto the bottle and has a kg-body weight scale.
Croatian: Štrcaljka odgovara bočici i ima mjerilo u kg-tjelesne težine.