FrancophonIA/ELRC3.0 huggingface dataset:
English: In this population, including some children above 12 years, Repatha showed a consistent reduction in LDLcholesterol levels beyond what can be achieved with existing fat-lowering medicines.
Croatian: U toj populaciji, koja je obuhvaćala i nekoliko djece starije od 12 godina, lijek Repatha pokazao je konzistentno smanjenje koncentracija LDL kolesterola, veće od onoga koje se može postići postojećim lijekovima za snižavanje koncentracija masnoća.
English: A second study showed that long-term use of Repatha achieved a sustained reduction of fat levels in the blood in these patients during 28 weeks of treatment.
Croatian: Drugim se ispitivanjem potvrdilo da se dugotrajnom primjenom lijeka Repatha postiže značajno smanjenje koncentracija masnoća u krvi u tih bolesnika tijekom 28 tjedana terapije.
English: Some of the studies looked at Repatha taken on its own, while others studied Repatha in combination with other fat-lowering medicines, including patients on the maximum recommended doses of statins.
Croatian: U nekim ispitivanjima istraženo je djelovanje lijeka Repatha koji se uzimao kao monoterapija, dok je u drugima istraženo djelovanje lijeka Repatha u kombinaciji s drugim lijekovima za snižavanje masnoća, uključujući bolesnike koji su primali maksimalne preporučene doze statina.
English: Repatha can also be used without a statin in patients who cannot take statins.
Croatian: U bolesnika koji ne podnose statine Repatha se može primjenjivati i bez statina.
English: Some studies compared Repatha with placebo (a dummy treatment) and others to another medicine (ezetimibe).
Croatian: U pojedinim ispitivanjima uspoređivan je lijek Repatha s placebom (prividno liječenje), dok su druga ispitivanja usporedila ovaj lijek s drugim lijekom (ezetimib).
English: How is Repatha used?
Croatian: Kako se Repatha koristi?
English: What benefits of Repatha have been shown in studies?
Croatian: Koje su koristi lijeka Repatha utvrđene u ispitivanjima?
English: In patients with atherosclerotic heart disease, Repatha reduced the number of cardiovascular events, in particular heart attacks and strokes.
Croatian: Liječenje lijekom Repatha smanjilo je broj kardiovaskularnih problema u bolesnika s aterosklerotskom bolešću srca, posebice srčanih i moždanih udara.
English: Repatha is used in combination with a statin or a statin and other fat-lowering medicines.
Croatian: Lijek Repatha primjenjuje se u kombinaciji sa statinom ili statinom i drugim lijekovima za snižavanje masnoća u krvi.
English: Some patients are required to be on a low fat diet.
Croatian: Prehrana s niskim udjelom masnoća nužna je u nekih bolesnika.
English: They received either Repatha or placebo, both with an optimal fat-lowering therapy, for over 2 years on average.
Croatian: Bolesnici su u prosjeku tijekom više od dvije godine primali lijek Repatha ili placebo u kombinaciji s optimalnom terapijom za snižavanje koncentracije masnoća u krvi.
English: For the full list of side effects and restrictions with Repatha, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Repatha potražite u uputi o lijeku.
English: Some specific preparations may be used in children between 4 and 12 years of age.
Croatian: Neki se posebni pripravci smiju koristiti u djece u dobi od 4 do 12 godina.
English: Primula root EMA/424238/2016
Croatian: EMA/424238/2016
English: Primula veris L. and/or Primula elatior (L.) Hill, radix
Croatian: Primula veris L. i/ili Primula elatior (L.) Hill, radix
English: Most primula root preparations should only be used in adults and adolescents over the age of 12 years.
Croatian: Većina pripravaka jaglačevog korijena smije se primjenjivati samo u odraslih osoba i adolescenata starijih od 12 godina.
English: What is primula root?
Croatian: Što je jaglačev korijen?
English: The solvent is then either fully or partially evaporated to obtain a dry or soft extract.
Croatian: Otapalo se zatim u potpunosti ili djelomično uparava kako bi se dobio suhi ili gusti ekstrakt.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 September 2016 EMA/424238/2016
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● Ujedinjena Kraljevina
English: longer than one week or worsen during the use of the medicine, a doctor or a qualified healthcare practitioner should be consulted.
Croatian: simptomi traju dulje od jednog tjedna ili se pogoršaju tijekom primjene lijeka, potrebno je obratiti se liječniku ili kvalificiranom zdravstvenom radniku.
English: There are no clinical studies with preparations containing primula root only.
Croatian: Nisu provedena klinička ispitivanja s pripravcima koji sadrže samo jaglačev korijen.
English: The HMPC conclusions only cover primula root preparations which are obtained by drying and comminuting (reducing into tiny pieces) the underground parts or using a technique to extract compounds by putting the plant material in a solvent (such as ethanol or methanol) to dissolve compounds and form a liquid extract.
Croatian: Zaključcima HMPC-a obuhvaćeni su samo pripravci jaglačevog korijena koji su dobiveni sušenjem i usitnjavanjem (smanjivanjem na manje komadiće) podzemnih dijelova ili primjenom tehnike za ekstrakciju spojeva stavljanjem biljnog materijala u otapalo (npr. etanol ili metanol) radi otapanja spojeva i dobivanja tekućeg ekstrakta.
English: Primula root is the common name for the underground parts of the plant Primula veris L. and/or Primula elatior (L.) Hill.
Croatian: Jaglačev korijen je uobičajeni naziv za podzemne dijelove biljke Primula veris L. i/ili Primula elatior (L.) Hill.
English: Further information on the HMPC assessment of primula root medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Croatian: Daljnje informacije o HMPC-ovoj ocjeni lijekova koji sadrže jaglačev korijen, uključujući pojedinosti zaključaka Povjerenstva, mogu se pronaći pod karticom „All documents” na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Any applications for the licensing of medicines containing primula root have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Croatian: Svi zahtjevi za odobrenje lijekova koji sadrže jaglačev korijen moraju se podnijeti nacionalnim tijelima nadležnima za lijekove, koja ocjenjuju zahtjev za biljni lijek i uzimaju u obzir znanstvene zaključke HMPC-a.
English: Primula root preparations may also be found in combination with other herbal substances in some herbal medicines.
Croatian: Pripravci jaglačevog korijena mogu postojati također i u kombinaciji s drugim biljnim tvarima u nekim biljnim lijekovima.
English: This summary is not intended to provide practical advice on how to use medicines containing primula root.
Croatian: Svrha ovog sažetka nije davati praktične savjete o načinu primjene lijekova koji sadrže jaglačev korijen.
English: Further information on the risks associated with these primula root medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Croatian: Više o rizicima povezanima s ovim lijekovima koji sadrže jaglačev korijen, uključujući odgovarajuće mjere opreza za njihovu sigurnu primjenu, možete pronaći u monografiji pod karticom „All documents” na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC conclusions on the use of these primula root medicines for coughs are based on their ‘traditional use'.
Croatian: Zaključci HMPC-a o primjeni lijekova koji sadrže jaglačev korijen za kašalj temelje se na njihovoj „tradicionalnoj primjeni”.
English: Herbal medicines containing these primula root preparations are usually available as herbal tea to be drunk and in liquid or solid forms to be taken by mouth.
Croatian: Biljni lijekovi koji sadrže te pripravke jaglačevog korijena najčešće su dostupni kao biljni čajevi koji se piju te u tekućem ili krutom obliku za uzimanje kroz usta.
English: Information on the use and licensing of primula root medicines in EU Member States should be obtained from the relevant national authorities.
Croatian: Informacije o primjeni i davanju odobrenja za lijekove koji sadrže jaglačev korijen u državama članicama EU-a mogu se dobiti od nadležnih nacionalnih tijela.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of primula root.
Croatian: Ovaj dokument predstavlja sažetak znanstvenih zaključaka Povjerenstva za biljne lijekove (HMPC) u pogledu medicinske primjene jaglačevog korijena.
English: Detailed instructions on how to take primula root medicines and who can use them can be found in the package leaflet that comes with the medicine.
Croatian: Detaljne upute o načinu uzimanja lijekova koji sadrže jaglačev korijen i o tome tko ih smije uzimati navedene su u uputi o lijeku koja je priložena uz lijek.
English: In its assessment, the HMPC considered laboratory studies which showed primula root increased production of airway secretions, making phlegm less thick and easier to expel.
Croatian: Prilikom svoje ocjene HMPC je razmotrio ispitivanja provedena u laboratoriju koja su pokazala da je jaglačev korijen povećao stvaranje sekreta u dišnim putovima, čime je smanjio gustoću sluzi i olakšao iskašljavanje.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing primula root.
Croatian: Države članice EU-a uzimaju u obzir zaključke HMPC-a prilikom ocjene zahtjeva za davanje odobrenja za biljne lijekove koji sadrže jaglačev korijen.
English: Other information about primula root medicines
Croatian: Ostale informacije o lijekovima koji sadrže jaglačev korijen
English: The HMPC concluded that, on the basis of its long-standing use, these primula root preparations can be used as an expectorant (a medicine that helps bring up phlegm) for coughs associated with colds.
Croatian: Na temelju dugotrajne primjene, HMPC je zaključio da se ovi pripravci jaglačevog korijena mogu koristiti kao ekspektorans (lijek za olakšavanje iskašljavanja sluzi) za kašalj uslijed prehlade.
English: What are the risks associated with primula root medicines?
Croatian: Koji su rizici povezani s lijekovima koji sadrže jaglačev korijen ?
English: For more information about treatment with primula root medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Croatian: Za više informacija o liječenju lijekovima koji sadrže jaglačev korijen pročitajte uputu o lijeku priloženu uz lijek, odnosno obratite se svom liječniku ili ljekarniku.
English: For practical information about using primula root medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Croatian: Za praktične informacije o primjeni lijekova koji sadrže jaglačev korijen bolesnici trebaju pročitati uputu o lijeku priloženu uz lijek, odnosno obratiti se svom liječniku ili ljekarniku.
English: How are primula root medicines approved in the EU?
Croatian: Kako se u EU-u odobravaju lijekovi koji sadrže jaglačev korijen?
English: What evidence supports the use of primula root medicines?
Croatian: Kojim se dokazima potkrjepljuje primjena lijekova koji sadrže jaglačev korijen?
English: If symptoms last
Croatian: Ako
English: See also information under the heading “Do not take Exforge”.
Croatian: Vidjeti također informacije pod naslovom „Nemojte uzimati Exforge“.
English: Exforge with food and drink
Croatian: Exforge s hranom i pićem
English: Exforge is not recommended in early pregnancy (first 3 months), and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Croatian: Exforge se ne preporučuje u ranoj trudnoći (prva 3 mjeseca) te se ne smije uzimati kada ste trudni više od 3 mjeseca, jer može ozbiljno naštetiti Vašem djetetu ako se uzima nakon trećeg mjeseca trudnoće.
English: If you take more Exforge than you should
Croatian: Ako uzmete više Exforgea nego što ste trebali
English: It is recommended to take Exforge with some water.
Croatian: Preporučuje se uzeti Exforge s nešto vode.
English: Exforge and older people (age 65 years or over) Your doctor should exercise caution when increasing your dose.
Croatian: Exforge i starije osobe (starosti od 65 ili više godina) Vaš liječnik treba oprezno postupati kod povećavanja doze.
English: What Exforge is and what it is used for
Croatian: Što je Exforge i za što se koristi
English: Date of first authorisation: 17 January 2007 Date of latest renewal: 22 November 2011
Croatian: Datum posljednje obnove odobrenja: 22. studeni 2011.
English: If you have taken too many tablets of Exforge, or if someone else has taken your tablets, consult a doctor immediately.
Croatian: Ako ste uzeli previše tableta Exforgea, ili ako je netko drugi uzeo Vaše tablete, odmah se posavjetujte s liječnikom.
English: After the transitional period of 2 years, a limit for NDMA of maximum 0.03 ppm should be implemented.
Croatian: Nakon prijelaznog razdoblja od dvije godine potrebno je primijeniti graničnu vrijednost za tvari NDMA od najviše 0,03 ppm.
English: Talk to your doctor before taking Exforge: if you have been sick (vomiting or diarrhoea).
Croatian: Obratite se svom liječniku prije nego uzmete Exforge: ako ste bili bolesni (povraćanje ili proljev).
English: Do not take Exforge if you are allergic to amlodipine or to any other calcium channel blockers.
Croatian: Nemojte uzimati Exforge ako ste alergični na amlodipin ili na bilo koji drugi blokator kalcijevih kanala.
English: Over 1,400 hypertensive patients received Exforge once daily in two placebo-controlled trials.
Croatian: Više od 1400 hipertenzivnih bolesnika primalo je Exforge jednom dnevno u dva placebo kontrolirana klinička ispitivanja.
English: Your doctor will normally advise you to stop taking Exforge before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Exforge.
Croatian: Liječnik će Vas u pravilu savjetovati da prekinete uzimati Exforge prije trudnoće ili čim saznate da ste trudni te će Vas savjetovati da uzmete drugi lijek umjesto Exforgea.
English: Correction of this condition prior to administration of Exforge or close medical supervision at the start of treatment is recommended.
Croatian: Preporučuje se korigiranje ovog stanja prije primjene Exforgea ili pažljiv liječnički nadzor na početku liječenja.
English: What Exforge contains
Croatian: Što Exforge sadrži
English: Other medicines and Exforge
Croatian: Drugi lijekovi i Exforge
English: In two long-term follow-up studies the effect of Exforge was maintained for over one year.
Croatian: U dva dugotrajna ispitivanja praćenja, učinak Exforgea bio je održan tijekom više od jedne godine.
English: Age, gender, race or body mass index (≥30 kg/m 2, <30 kg/m 2) did not influence the response to
Croatian: Dob, spol, rasa ili indeks tjelesne mase (≥30 kg/m2, <30 kg/m2) nisu utjecali na odgovor na Exforge.
English: What you need to know before you take Exforge
Croatian: Što morate znati prije nego počnete uzimati Exforge
English: To date there is no experience of the safe use of Exforge in patients who have had a recent kidney transplantation.
Croatian: Do danas ne postoji iskustvo o sigurnoj primjeni Exforgea u bolesnika kojima je nedavno transplantiran bubreg.
English: The safety and efficacy of Exforge in children aged below 18 years have not been established.
Croatian: Sigurnost i djelotvornost Exforgea u djece u dobi ispod 18 godina nisu ustanovljene.
English: Children and adolescents The use of Exforge in children and adolescents is not recommended (aged below 18 years old).
Croatian: Primjena Exforgea u djece i adolescenata se ne preporučuje (ispod 18 godina starosti).
English: If a diurectic is also used, the risk of lithium toxicity may presumably be increased further with Exforge.
Croatian: Ako se diuretik također koristi, rizik od toksičnosti litija vjerojatno se može povećati i više s Exforgeom.
English: Do not take Exforge with grapefruit or grapefruit juice.
Croatian: Ne uzimajte Exforge s grejpom ili sokom od grejpa.
English: Exforge is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Croatian: Exforge se ne preporučuje majkama koje doje, a ako želite dojiti liječnik Vam može odabrati drugo liječenje, posebno ako je Vaše dijete novorođenče ili je prijevremeno rođeno.
English: The usual dose of Exforge is one tablet per day.
Croatian: Uobičajena doza Exforgea je jedna tableta na dan.
English: Patients taking Exforge and driving vehicles or using machines should take into account that dizziness or weariness may occasionally occur.
Croatian: Bolesnici koji uzimaju Exforge i upravljaju vozilima ili rade na strojevima trebaju imati na umu da se katkada mogu javiti omaglica ili iscrpljenost.
English: What Exforge is and what it is used for What you need to know before you take Exforge How to take Exforge
Croatian: Što je Exforge i za što se koristi Što morate znati prije nego počnete uzimati Exforge Kako uzimati Exforge
English: If you get these symptoms, stop taking Exforge and contact your doctor straight away.
Croatian: Ako dobijete ove simptome, prekinite uzimati Exforge i odmah se javite svom liječniku.
English: N-nitrosodimethylamine (NDMA)
Croatian: Za N-nitrozodimetilamin (NDMA)
English: The recommended dose of Exforge is one tablet per day.
Croatian: Preporučena doza Exforgea je jedna tableta na dan.
English: Stopping your treatment with Exforge may cause your disease to get worse.
Croatian: Prestanak liječenja Exforgeom može dovesti do pogoršanja bolesti od koje bolujete.
English: Exforge has not been studied in any patient population other than hypertension.
Croatian: Exforge nije ispitivan ni u jednoj drugoj populaciji bolesnika, osim u bolesnika s hipertenzijom.
English: Exforge can be used with or without food.
Croatian: Exforge se može primjenjivati s hranom ili bez nje.
English: You can take Exforge with or without food.
Croatian: Exforge možete uzimati s hranom ili bez nje.
English: The safety of Exforge has been evaluated in five controlled clinical studies with 5,175 patients, 2,613 of whom received valsartan in combination with amlodipine.
Croatian: Sigurnost Exforgea je ispitivana u pet kontroliranih kliničkih ispitivanja s 5175 bolesnika, od kojih je 2613 primalo valsartan u kombinaciji s amlodipinom.
English: No drug-drug interaction studies have been performed with Exforge and other medicinal products.
Croatian: Nisu provedena ispitivanja interakcija među lijekovima s Exforgeom i drugim lijekovima.
English: Other possible side effects of Exforge:
Croatian: Ostale moguće nuspojave Exforgea:
English: Exforge combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: amlodipine belongs to the calcium antagonist class and valsartan to the angiotensin II antagonist class of medicines.
Croatian: Exforge kombinira dva antihipertenzivna sastojka s komplementarnim mehanizmima kontrole krvnog tlaka u bolesnika s esencijalnom hipertenzijom: amlodipin pripada skupini kalcijevih antagonista, dok valsartan pripada skupini antagonista angiotenzina II.
English: Exforge tablets contain two substances called amlodipine and valsartan.
Croatian: Exforge tablete sadrže dvije djelatne tvari koje se zovu amlodipin i valsartan.
English: Abrupt withdrawal of Exforge has not been associated with a rapid increase in blood pressure.
Croatian: Nagli prekid primjene Exforgea nije bio povezan s naglim povišenjem krvnog tlaka.
English: If you stop taking Exforge
Croatian: Ako prestanete uzimati Exforge
English: Clinically significant hypotension due to Exforge overdose calls for active cardiovascular support, including frequent monitoring of cardiac and respiratory function, elevation of extremities, and attention to circulating fluid volume and urine output.
Croatian: Klinički značajna hipotenzija zbog predoziranja Exforgeom zahtijeva aktivnu kardiovaskularnu potporu, uključujući često praćenje srčane i respiratorne funkcije, podizanje ekstremiteta, uz praćenje volumena cirkulirajuće tekućine i mokrenja.
English: Exforge is available in packs containing 7, 14, 28, 30, 56, 90, 98 or 280 tablets and in multipacks comprising 4 cartons, each containing 70 tablets, or 20 cartons, each containing 14 tablets.
Croatian: Exforge je dostupan u pakiranjima koja sadrže 7, 14, 28, 30, 56, 90, 98 ili 280 tableta i u višestrukim pakiranjima koji sadrže 4 kutije, od kojih svaka sadrži 70 tableta, ili 20 kutija, od kojih svaka sadrži 14 tableta.
English: Adverse reactions previously reported with one of the individual components (amlodipine or valsartan) may be potential adverse reactions with Exforge as well, even if not observed in clinical trials or during the post-marketing period.
Croatian: Dodatne informacije o pojedinačnim komponentama Nuspojave koje su ranije prijavljene s jednom od pojedinačnih komponenti (amlodipinom ili valsartanom) mogu biti i moguće nuspojave Exforgea, iako nisu uočene u kliničkim ispitivanjima ili nakon stavljanja lijeka u promet.
English: Exforge was also studied in an active-controlled study of 130 hypertensive patients with mean sitting diastolic blood pressure ≥110 mmHg and <120 mmHg.
Croatian: Exforge je također ispitivan u aktivno kontroliranom kliničkom ispitivanju sa 130 hipertenzivnih bolesnika sa srednjom vrijednošću dijastoličkog krvnog tlaka u sjedećem položaju ≥110 mmHg i <120 mmHg.
English: The rate and extent of absorption of Exforge are equivalent to the bioavailability of valsartan and amlodipine when administered as individual tablets.
Croatian: Brzina i opseg apsorpcije Exforgea jednaki su bioraspoloživosti valsartana i amlodipina kada se primjenjuju kao pojedinačne tablete.
English: No information is available regarding the use of Exforge during breast-feeding, therefore Exforge is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Croatian: Budući da nisu dostupne informacije o primjeni Exforgea tijekom dojenja, stoga se Exforge tijekom dojenja ne preporučuje te se savjetuje alternativno liječenje s bolje utvrđenim sigurnosnim profilom tijekom dojenja, posebno kod dojenja novorođenčeta ili nedonoščeta.
English: Exforge should be used with caution to treat hypertension in patients with unilateral or bilateral renal artery stenosis or stenosis to a solitary kidney since blood urea and serum creatinine may increase in such patients.
Croatian: Exforge se treba primjenjivati s oprezom u liječenju hipertenzije u bolesnika s jednostranom ili obostranom stenozom bubrežne arterije ili stenozom bubrežne arterije kod postojanja samo jednog bubrega budući da se u ovih bolesnika može povisiti urea u krvi i serumski kreatinin.
English: The amlodipine component of Exforge inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
Croatian: Amlodipinska komponenta Exforgea inhibira transmembranski ulaz iona kalcija u srčani mišić i glatki mišić krvnih žila.
English: If hypotension occurs with Exforge, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline.
Croatian: Ako se uz Exforge pojavi hipotenzija, bolesnika treba poleći na leđa i po potrebi, mu dati intravensku infuziju fiziološke otopine.