FrancophonIA/ELRC3.0 huggingface dataset:
English: Although once daily dosing comes with a risk of cortisol levels being too low in the afternoon, this can be managed by adding further doses of hydrocortisone if needed.
Croatian: Iako je doziranje lijeka jedanput dnevno povezano s rizikom da će razine kortizola poslijepodne biti preniske, to se može ispraviti dodavanjem doza hidrokortizona prema potrebi.
English: It is not intended to provide practical advice on how to use Plenadren.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Plenadren.
English: Plenadren is a medicine used to treat adrenal insufficiency in adults.
Croatian: Plenadren je lijek koji se upotrebljava za liječenje adrenalne insuficijencije u odraslih osoba.
English: Plenadren, given once per day, was compared with conventional hydrocortisone treatment, which is given three times per day.
Croatian: Plenadren, uziman jedanput dnevno, uspoređen je s konvencionalnim liječenjem hidrokortizonom pri kojemu se lijek uzima triput dnevno.
English: The CHMP concluded that the benefits of Plenadren were greater than its risks and recommended that it be granted marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Plenadren nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: For more information about treatment with Plenadren, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Plenadren pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: How does Plenadren work?
Croatian: Kako djeluje Plenadren?
English: The effects of Plenadren were investigated in one main study involving 64 patients with adrenal insufficiency.
Croatian: Učinci lijeka Plenadren ispitani su u jednom glavnom ispitivanju na 64 bolesnika s adrenalnom insuficijencijom.
English: Plenadren contains the active substance hydrocortisone.
Croatian: Plenadren sadržava djelatnu tvar hidrokortizon.
English: How is Plenadren used?
Croatian: Kako se Plenadren koristi?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that Plenadren achieved satisfactory levels of cortisol during the treatment of patients with adrenal insufficiency.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je da se primjenom lijeka Plenadren postiže zadovoljavajuća razina kortizola u liječenju bolesnika s adrenalnom insuficijencijom.
English: The Committee also noted that with Plenadren there is the convenience of once daily dosing.
Croatian: Odbor je također zaključio da je doziranje lijeka Plenadren jedanput dnevno dodatna prednost.
English: Because it is available as a modified-release tablet, Plenadren releases hydrocortisone over a longer period of time allowing for a once-daily dosing.
Croatian: Budući da je dostupan u obliku tableta s prilagođenim oslobađanjem, Plenadren otpušta hidrokortizon tijekom duljeg razdoblja, zbog čega je dovoljno uzimanje jedanput dnevno.
English: For practical information about using Plenadren, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Plenadren bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: The active substance in Plenadren, hydrocortisone, is the pharmaceutical form of cortisol, the main steroid hormone secreted by the adrenal gland.
Croatian: Djelatna tvar lijeka Plenadren, hidrokortizon, farmaceutski je oblik kortizola, glavnog steroidnog hormona koji izlučuju nadbubrežne žlijezde.
English: Hydrocortisone replaces the natural cortisol that is missing in patients with adrenal insufficiency.
Croatian: Hidrokortizon nadomješta nedostatak prirodnog kortizola u bolesnika s adrenalnom insuficijencijom.
English: What benefits of Plenadren have been shown in studies?
Croatian: Koje su koristi lijeka Plenadren dokazane u ispitivanjima?
English: For the full list of all side effects and restrictions with Plenadren, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Plenadren potražite u uputi o lijeku.
English: In patients taking Plenadren the cortisol levels achieved were considered to be satisfactory for patients with adrenal insufficiency.
Croatian: Procijenjeno je da su postignute razine kortizola u bolesnika koji su uzimali Plenadren zadovoljavajuće za bolesnike s adrenalnom insuficijencijom.
English: Ristfor is taken twice a day.
Croatian: Ristfor se uzima dva puta na dan.
English: Metformin has been available in the EU since the 1950s.
Croatian: Metformin je dostupan u EU-u od 1950-ih.
English: This authorisation was based on the authorisation granted to Janumet in 2008 (‘informed consent').
Croatian: Odobrenje se temelji na odobrenju izdanom za cjepivo Janumet 2008. godine („informirani pristanak”).
English: The full EPAR for Ristfor can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Ristfor nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Sitagliptin has been authorised in the European Union (EU) as Januvia and Xelevia since 2007 and as Tesavel since 2008.
Croatian: Sitagliptin je odobren u Europskoj uniji (EU) kao Januvia i Xelevia od 2007., te kao Tesavel od 2008.
English: The maximum dose of sitagliptin is 100 mg a day.
Croatian: Maksimalna doza sitagliptina je 100 mg na dan.
English: It is used in addition to diet and exercise in the following ways:
Croatian: Koristi se kao dodatak prehrani i tjelovježbi na sljedeće načine:
English: This summary was last updated in 01-2015.
Croatian: Sažetak je posljednji put ažuriran: 01. 2015.
English: Sitagliptin is a dipeptidyl-peptidase-4 (DPP 4) inhibitor.
Croatian: Sitagliptin je inhibitor dipeptidil-peptidaze4 (DPP 4).
English: It works by blocking the breakdown of ‘incretin' hormones in the body.
Croatian: Djeluje tako što sprječava razgradnju „inkretinskih” hormona u tijelu.
English: Ristfor sitagliptin / metformin hydrochloride
Croatian: Ristfor sitagliptin / metformin hidroklorid
English: There was no difference in this effect between the patients also taking metformin and those not taking it.
Croatian: Nije utvrđena razlika između bolesnika koji su također uzimali metformin i onih koji ga nisu uzimali.
English: Why has Ristfor been approved?
Croatian: Zašto je Ristfor odobren?
English: What measures are being taken to ensure the safe and effective use of Ristfor?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ristfor ?
English: It is available as tablets (50 mg sitagliptin and 850 mg metformin hydrochloride; 50 mg sitagliptin and 1,000 mg metformin hydrochloride).
Croatian: Dostupan je u obliku tableta (50 mg sitagliptina i 850 mg metformin hidroklorida; 50 mg sitagliptina i 1 000 mg metformin hidroklorida).
English: It must also not be used in patients who consume excessive amounts of alcohol or are alcoholic, or in women who are breast-feeding.
Croatian: Također se ne smije koristiti u bolesnika koji prekomjerno konzumiraju alkohol ili su alkoholičari, odnosno u dojilja.
English: The strength of tablet to use depends on the dose of the other diabetes medicines that the patient was taking before.
Croatian: Jačina tablete koja se primjenjuje ovisi o dozi drugih lijekova protiv dijabetesa koje je bolesnik prethodno uzimao.
English: The European Commission granted a marketing authorisation valid throughout the EU for Ristfor on 15 March 2010.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Ristfor na snazi u Europskoj uniji od 15. ožujka 2010.
English: Ristfor should be taken with food to avoid any stomach problems caused by metformin.
Croatian: Ristfor treba uzimati s hranom kako bi se izbjegli bilo kakvi problemi uzrokovani metforminom.
English: • in patients who are already taking a combination of sitagliptin and metformin as separate tablets;
Croatian: • u bolesnika koji već uzimaju kombinaciju sitagliptina i metformina kao zasebne tablete;
English: The company carried out additional studies to show that the active substances in Ristfor are absorbed by the body in the same way as the two medicines given separately.
Croatian: Tvrtka je provela dodatna ispitivanja kako bi dokazala da su djelatne tvari lijeka Ristfor apsorbirane u tijelu na isti način kao dva lijeka koja su zasebno primijenjena.
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 Ristfor.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i svoje preporuke za uporabu lijeka Ristfor.
English: For more information about treatment with Ristfor, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Ristfor pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Serious side effects reported with Ristfor include pancreatitis (inflammation of the pancreas) and hypersensitivity (allergic reactions).
Croatian: Ozbiljne nuspojave prijavljene s lijekom Ristfor uključuju pankreatitis (upalu gušterače) i preosjetljivost (alergijske reakcije).
English: In all of the studies, the main measure of effectiveness was the change in the levels of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Croatian: U svim ispitivanjima, glavna mjera djelotvornosti bila je promjena u razini tvari u krvi naziva glikozilirani hemoglobin (HbA1c), koji ukazuje na to koliko se dobro kontrolira glukoza u krvi.
English: Ristfor must not be used in patients who have diabetic ketoacidosis or pre coma (dangerous conditions that can occur in diabetes), problems with the kidneys or liver, conditions that may affect the kidneys, or a disease that causes a reduced supply of oxygen to the tissues such as failure of the heart or lungs or a recent heart attack.
Croatian: Ristfor se ne smije koristiti u bolesnika s dijabetičkom ketoacidozom ili pred komom (opasnim stanjem koje može nastupiti u dijabetesu), problemima s bubrezima ili jetrom, stanjima koja mogu zahvatiti bubrege ili bolešću koja može uzrokovati smanjivanje isporuke kisika u tkivo poput zatajenja srca ili pluća ili nedavno preboljenog infarkta miokarda.
English: The effectiveness of adding sitagliptin to metformin was similar to that of adding glipizide.
Croatian: Djelotvornost dodavanja sitagliptina metforminu bile je slična onoj dodavanja glipizida.
English: This study also compared the effects of adding sitagliptin or placebo.
Croatian: Ovo je ispitivanje usporedilo djelovanje dodavanja sitagliptina ili placeba.
English: The company presented the results of three studies of Januvia/Xelevia to support the use of Ristfor in patients who were not satisfactorily controlled on their existing metformin treatment.
Croatian: Tvrtka je dostavila rezultate tri ispitivanja lijekova Januvia/Xelevia koji podržavaju primjenu lijeka Ristfor u bolesnika čije stanje nije na zadovoljavajući način kontrolirano postojećom terapijom metforminom.
English: Hypoglycaemia has been reported in combination with a sulphonylurea in 13.8% of patients and with insulin in 10.9% of patients.
Croatian: Hipoglikemija je prijavljena u kombinaciji sa sulfonilurejom u 13,8% bolesnika i s inzulinom u 10,9% bolesnika.
English: A risk management plan has been developed to ensure that Ristfor is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Ristfor.
English: Other information about Ristfor:
Croatian: Ostale informacije o lijeku Ristfor:
English: Ristfor was more effective than metformin alone.
Croatian: Ristfor je bio djelotvorniji od monoterapije metforminom.
English: The third included 641 patients who were not satisfactorily controlled on a stable dose of insulin, three-quarters of whom were also taking metformin.
Croatian: Treće je ispitivanje obuhvatilo 641 bolesnika čije stanje nije na zadovoljavajući način kontrolirano stabilnom dozom inzulina, od kojih je tri četvrtine također uzimalo metformin.
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 jest bolest koja nastupa kada gušterača ne proizvodi dovoljno inzulina za kontrolu razine glukoze u krvi ili kada tijelo ne može učinkovito koristiti inzulin.
English: If Ristfor is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered, to avoid hypoglycaemia (low blood sugar levels).
Croatian: Ako se Ristfor uzima sa sulfonilurejom ili inzulinom, dozu sulfonilureja ili inzulina možda će trebati smanjiti kako bi se smanjio rizik od hipoglikemije (niskih razina šećera u krvi).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ristfor, 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 Ristfor nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: This document is a summary of the European Public Assessment Report (EPAR) for Ristfor.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Ristfor.
English: In the first of the three further studies, Ristfor was more effective than metformin or sitagliptin alone.
Croatian: U prvom od tri daljnja ispitivanja Ristfor je bio djelotvorniji od monoterapije metforminom ili sitagliptinom.
English: Ristfor is used in patients with type 2 diabetes to improve the control of blood glucose (sugar) levels.
Croatian: Ristfor se koristi u bolesnika s dijabetesom tipa 2 za poboljšanje kontrole razine glukoze (šećera) u krvi.
English: The CHMP decided that Ristfor's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Ristfor nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: What is the risk associated with Ristfor?
Croatian: Koji su rizici povezani s lijekom Ristfor?
English: By increasing the levels of incretin hormones in the blood, sitagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high.
Croatian: Povećavajući razine inkretinskih hormona u krvi, saksagliptin stimulira gušteraču kako bi gušterača proizvela više inzulina kada su razine glukoze u krvi visoke.
English: Sitagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Croatian: Saksagliptin također snižava količinu glukoze koju proizvodi jetra tako što povećava razine inzulina i snižava razine hormonskog glukagona.
English: These hormones are released after a meal and stimulate the pancreas to produce insulin.
Croatian: Ti se hormoni otpuštaju nakon obroka i stimuliraju gušteraču na proizvodnju inzulina.
English: Ristfor is a diabetes medicine that contains two active substances, sitagliptin and metformin hydrochloride.
Croatian: Ristfor je lijek koji sadrži dvije djelatne tvari: saksagliptin i metformin hidroklorid.
English: Metformin works mainly by inhibiting glucose production and reducing its absorption in the gut.
Croatian: Metformin djeluje uglavnom tako što sprječava stvaranje glukoze i smanjuje njezinu apsorpciju u crijevima.
English: What is Ristfor?
Croatian: Što je Ristfor?
English: The results of three further studies were used to support the use of Ristfor.
Croatian: Rezultati ta tri ispitivanja korišteni su kako bi se podržala primjena lijeka Ristfor.
English: Sitagliptin does not work when the blood glucose is low.
Croatian: Saksagliptin ne djeluje ako su razine glukoze niske.
English: The third study compared sitagliptin with placebo, when used as an add-on to glimepiride (another sulphonylurea), with or without metformin, in 441 patients.
Croatian: Treće je ispitivanje usporedilo sitagliptin s placebom, u slučaju kada se koristio kao dodatak terapiji glimepiridom (drugi lijek iz grupe sulfonilureja), s ili bez metformina, u 441 bolesnika.
English: Two of the studies looked at sitagliptin as an add-on to metformin: the first compared it with placebo (a dummy treatment) in 701 patients, and the second compared it with glipizide (a sulphonylurea) in 1,172 patients.
Croatian: Dva od provedenih ispitivanja istražila su sitagliptin kao dodatak metforminu: prvo ga je usporedilo s placebom (liječenjem bez djelatne tvari) u 701 bolesnika, a drugo ga je usporedilo s glipizidom (sulfonilurejom) u 1 172 bolesnika.
English: The first included 1,091 patients who were not satisfactorily controlled on diet and exercise alone and compared the effect of Ristfor with that of metformin or sitagliptin alone.
Croatian: Prvo je ispitivanje obuhvatilo 1 091 bolesnika koji nisu na zadovoljavajući način samostalno kontrolirali prehranu i vježbanje, te je usporedilo djelovanje lijeka Ristfor s djelovanjem monoterapije metforminom ili sitagliptinom.
English: The second included 278 patients who were not satisfactorily controlled on the combination of metformin and rosiglitazone (a PPAR-gamma agonist) and compared the effects of adding sitagliptin or placebo.
Croatian: Drugo je ispitivanje obuhvatilo 278 bolesnika kčije stanje nije na zadovoljavajući način kontrolirano kombinacijom metformina i rosiglitazona (agonistom PPAR-gama), te je usporedilo djelovanje sitagliptina ili placeba.
English: Sitagliptin on its own as Januvia/Xelevia/Tesavel can be used with metformin, and with both metformin and a sulphonylurea, in type 2 diabetes patients.
Croatian: Samostalno, pod nazivima Januvia/Xelevia/Tesavel, sitagliptin se može koristiti kao metformin, te s metforminom i sulfonilurejom u bolesnika s dijabetesom tipa
English: What is Ristfor used for?
Croatian: Za što se Ristfor koristi?
English: As a result of the action of both active substances, blood glucose levels are reduced and this helps to control type 2 diabetes.
Croatian: Rezultat djelovanja obje djelatne tvari je snižavanje koncentracija glukoze u krvi, što pomaže u kontroli dijabetesa tipa 2.
English: • in patients who are not satisfactorily controlled on metformin (a diabetes medicine) used on its own;
Croatian: • u bolesnika čije se stanje ne može u zadovoljavajućoj mjeri kontrolirati monoterapijom metforminom (lijekom za dijabetes);
English: The active substances in Ristfor, sitagliptin and metformin hydrochloride, each have a different mode of action.
Croatian: Djelatne tvari u lijeku Ristfor, saksagliptin i metformin hidroklorid, imaju različite načine djelovanja.
English: What benefit has Ristfor shown during the studies?
Croatian: Koje su koristi lijeka Ristfor utvrđene u ispitivanjima?
English: Adding 100 mg sitagliptin to metformin reduced HbA1c levels by 0.67% (from around 8.0%) after 24 weeks, compared with a fall of 0.02% in the patients adding placebo.
Croatian: Dodavanje 100 mg sitagliptina metforminu smanjilo je razine HbA1c za 0,67% (s otprilike 8,0%) nakon 24 tjedna, u usporedbi sa smanjenjem od 0,02% u bolesnika koji su dodavali placebo.
English: In the second, HbA1c levels were reduced by 1.03% after 18 weeks in patients adding sitagliptin to metformin and rosiglitazone, compared with a fall of 0.31% in those adding placebo.
Croatian: U drugom su razine HbA1c smanjene za 1,03% nakon 18 tjedana u bolesnika koji su dodavali sitagliptin metforminu i rosiglitazonu, u usporedbi sa smanjenjem od 0,31% u bolesnika koji su dodavali placebo.
English: In the study in which sitagliptin was added to glimepiride and metformin, the levels of HbA1c were reduced by 0.59% after 24 weeks, compared with an increase of 0.30% in the patients adding placebo.
Croatian: U ispitivanju u kojem je sitagliptin dodan glimepiridu i metforminu, razine HbA1c smanjene su za 0,59% nakon 24 tjedna, u usporedbi s povećanjem od 0,30% u bolesnika koji su dodavali placebo.
English: How is Ristfor used?
Croatian: Kako se Ristfor koristi?
English: Finally, they were reduced by 0.59% after 24 weeks in patients adding sitagliptin to insulin, compared with a fall of 0.03% in those adding placebo.
Croatian: Naposljetku, razine su smanjenje za 0,59% nakon 24 tjedna u bolesnika koji su dodavali sitagliptin inzulinu u usporedbi sa smanjenjem od 0,03% u bolesnika koji su dodavali placebo.
English: How has Ristfor been studied?
Croatian: Kako je Ristfor ispitivan?
English: How does Ristfor work?
Croatian: Kako djeluje Ristfor?
English: • in combination with a sulphonylurea, a PPAR-gamma agonist such as a thiazolidinedione, or insulin
Croatian: • u kombinaciji sa sulfonilurejom, agonistom PPAR-gama poput tiazolidinediona, ili inzulinom (drugim tipovima lijeka za dijabetes) u bolesnika čije se stanje ne može u zadovoljavajućoj mjeri kontrolirati ovim lijekom i metforminom.
English: For the full list of all side effects reported with Ristfor, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Ristfor potražite u uputi o lijeku.
English: This summary was last updated in June 2014.
Croatian: Sažetak je posljednji put ažuriran u lipnju 2014.
English: Equine influenza is a highly contagious disease that is very common in horses but rarely causes death.
Croatian: Konjska influenca visoko je zarazna bolest koja je vrlo česta u konja, ali rijetko uzrokuje smrt.
English: The effectiveness of ProteqFlu-Te was first assessed in several laboratory and field studies.
Croatian: Djelotvornost cjepiva ProteqFlu-Te procijenjena je prvo u nekoliko laboratorijskih i terenskih ispitivanja.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for ProteqFlu-Te on 6 March 2003.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je na snazi na teritoriju Europske unije za proizvod ProteqFlu-Te dana 6. ožujka 2003.
English: Horses are among the most susceptible species to tetanus.
Croatian: Konji su među najosjetljivijim životinjskim vrstama na tetanus.
English: The muscle stiffness usually starts from the jaw and neck, then affects the whole body.
Croatian: Ukočenost mišića obično počinje od čeljusti i vrata, a potom zahvaća cijelo tijelo.
English: Other information about ProteqFlu-Te:
Croatian: Ostale informacije o VMP-u ProteqFlu-Te:
English: The immunogenicity of the current formulation of the vaccine was confirmed in 15 foals.
Croatian: Imunogeničnost trenutne formulacije cjepiva potvrđena je na 15 ždrebadi.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against diseases.
Croatian: Cjepiva djeluju „učenjem” imunosnog sustava (prirodnog obrambenog mehanizma) kako se obraniti od bolesti.
English: The vaccine also stimulates protection against tetanus to prevent mortality.
Croatian: Cjepivo također stimulira zaštitu od tetanusa kako bi se spriječila smrtnost.
English: ProteqFlu-Te is available as a suspension for injection.
Croatian: ProteqFlu-Te je dostupan kao suspenzija za injekciju.
English: Tetanus is an acute, often fatal disease caused by the neurotoxin of the bacterium Clostridium tetani.
Croatian: Tetanus je akutna, često smrtonosna bolest uzrokovana neurotoksinom bakterije Clostridium tetani.
English: Horses should receive a primary vaccination, consisting of two injections at 5-6 months of age, given 4-6 weeks apart.
Croatian: Konji trebaju primiti prvo cijepljenje koje se sastoji od dvije injekcije u dobi od 5 do 6 mjeseci, a daju se u razmaku od 4 do 6 tjedana.