FrancophonIA/ELRC3.0 huggingface dataset:
English: In cats, Melosus is used to reduce pain and inflammation after orthopaedic and minor soft tissue surgery.
Croatian: U mačaka se VMP Melosus primjenjuje za ublažavanje bolova i upale nakon ortopedskih i manjih kirurških zahvata na mekom tkivu.
English: How does Melosus work?
Croatian: Kako djeluje Melosus?
English: Melosus contains the active substance meloxicam and is a ‘generic medicine'.
Croatian: Melosus sadržava djelatnu tvar meloksikam te je „generički lijek”.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Melosus, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Croatian: U sažetku opisa svojstava VMP-a, kao i u uputi o VMP-u Melosus, nalaze se informacije o sigurnosti primjene, uključujući odgovarajuće mjere opreza kojih se veterinari te vlasnici životinja i uzgajivači trebaju pridržavati.
English: In guinea pigs Melosus is used to reduce pain after soft tissue surgery such as castration.
Croatian: U zamorčadi se VMP Melosus primjenjuje za ublažavanje bolova nakon kirurških zahvata na mekom tkivu kao što je kastracija.
English: In dogs, Melosus is used to lessen inflammation and pain in musculo-skeletal disorders.
Croatian: U pasa se VMP Melosus primjenjuje za ublažavanje upale i bolova kod mišićno-koštanih poremećaja.
English: How is Melosus used?
Croatian: Kako se Melosus primjenjuje?
English: How has Melosus been studied?
Croatian: Kako se VMP Melosus ispitivao?
English: • hypertension;
Croatian: • hipertenzije;
English: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Spain, Sweden and United Kingdom, as well as in Iceland and Norway.
Croatian: Plendil i povezani nazivi trenutno su stavljeni u promet u sljedećim državama članicama EU: Austriji, Belgiji, Bugarskoj, Hrvatskoj, Cipru, Češkoj Republici, Danskoj, Estoniji, Finskoj, Francuskoj, Njemačkoj, Grčkoj, Mađarskoj, Irskoj, Italiji, Latviji, Litvi, Luksemburgu, Malti, Nizozemskoj, Poljskoj, Portugalu, Rumunjskoj, Slovačkoj, Španjolskoj, Švedskoj i Ujedinjenoj Kraljevini te na Islandu i u Norveškoj.
English: What is Plendil?
Croatian: Što je Plendil?
English: Why was Plendil reviewed?
Croatian: Zašto je Plendil pregledan?
English: The European Commission issued an EU-wide legally binding decision to implement these changes on 16 December 2014.
Croatian: Europska komisija izdala je pravno obvezujuću odluku na razini EU-a za primjenu ovih izmjena na dan 16. prosinca 2014.
English: Plendil and associated names have been authorised in EU Member States through national procedures since 1987.
Croatian: Plendil i povezani nazivi odobreni su u državama članicama EU-a putem nacionalnih postupaka od 1987. godine.
English: The company that markets these medicines is AstraZeneca.
Croatian: Tvrtka koja stavlja u promet ovaj lijek je AstraZeneca.
English: EMEA/H/A-30/1388
Croatian: EMA/790566/2014 EMEA/H/A-30/1388
English: Plendil contains the active substance felodipine.
Croatian: Plendil sadrži djelatnu tvar felodipin.
English: The CHMP also harmonised other sections of the SmPC, including sections 4.4 (special warnings and precautions for use), 4.6 (fertility, pregnancy and lactation) and 4.8 (side effects).
Croatian: CHMP je također uskladio druge dijelove SPC-a, uključujući dijelove 4.4 (posebna upozorenja i mjere opreza za uporabu), 4.6 (plodnost, trudnoća i laktacija) i 4.8 (nuspojave).
English: Plendil is a medicine used to treat hypertension (high blood pressure).
Croatian: Plendil je lijek koji se koristi za liječenje hipertenzije (visokog krvnog tlaka).
English: The medicine is available as prolonged release tablets (2.5, 5 and 10 mg) which release the active substance over an extended period of time.
Croatian: Lijek je dostupan kao tablete s produljenim oslobađanjem (2,5, 5 i 10 mg) koje oslobađaju djelatnu tvar tijekom produljenog vremenskog razdoblja.
English: • stable angina pectoris (a type of angina pectoris that occurs with activity or stress).
Croatian: • stabilne angine pektoris (tipa angine pektoris koji nastupa uslijed aktivnosti ili stresa).
English: After reviewing the available data supporting the medicine's use, the CHMP agreed that Plendil can be used to treat the following:
Croatian: Nakon pregleda dostupnih podataka koji podržavaju primjenu lijeka, CHMP je suglasan da se Plendil može koristiti za liječenje sljedećeg:
English: Having harmonised the indications, the CHMP also harmonised recommendations on the doses and recommendations for special populations.
Croatian: Nakon usklađivanja indikacija, CHMP je također uskladio preporuke za doze i preporuke za posebne populacije.
English: The CHMP agreed to include the following contraindications in the product information: hypersensitivity (allergy) to felodipine or to any other ingredients; pregnancy; decompensated heart failure (worsening of symptoms in patients with heart problems); acute myocardial infarction (heart attack); unstable angina pectoris (a type of chest pain that happens suddenly, even at rest or asleep, and which may lead to a heart attack), and certain types of heart valve and bloodflow obstructions.
Croatian: CHMP je suglasan s uključivanjem sljedećih kontraindikacija u informacije o proizvodu: preosjetljivost (alergija) na felodipin ili na bilo koji drugi sastojak; trudnoća; dekompenzirano zatajenje srca (pogoršanje simptoma u bolesnika sa srčanim problemima); akutni infarkt miokarda (infarkt miokarda); nestabilna angina pektoris (tip boli u prsima koja se pojavljuje iznenada čak i u mirovanju i spavanju, što može rezultirati infarktom miokarda), kao i određeni tipovi opstrukcija srčanog zaliska i protoka krvi.
English: On 23 October 2014, the European Medicines Agency completed a review of Plendil and associated names.
Croatian: Dana 23. listopada 2014., Europska medicinska agencija završila je pregled lijeka Plendil kao i povezanih mu naziva.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Plendil and associated names in the European Union (EU).
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je da postoji potreba za usklađivanjem informacija za propisivanje za lijek Plendil i povezane nazive u Europskoj uniji (EU).
English: As Plendil has been authorised in the EU via national procedures, this has led to divergences across Member States in the way the medicine can be used, as seen in differences in the SmPCs (summary of product characteristics), labelling and package leaflets in the countries where the medicine is marketed.
Croatian: Budući da je Plendil odobren u EU-u putem nacionalnih postupaka, to je rezultiralo razlikama diljem država članica u načinu primjene, što je uočeno u razlikama u SPC-ovima (sažetcima opisa svojstava lijeka), etiketama i uputama za uporabu lijeka u državama u kojima je lijek stavljen u promet.
English: It is also used to treat angina pectoris (chest pain that occurs due to problems with the blood flow to the heart).
Croatian: Također se koristi za liječenje angine pektoris (boli u prsima koja nastupa uslijed problema povezanih s protokom krvi u srcu).
English: The Committee also agreed that Plendil should no longer be recommended to treat ‘vasospastic angina pectoris' (another type of angina pectoris caused by spasms in the vessels supplying blood to the heart), because the available data to support this use were considered too limited.
Croatian: Obor je također suglasan da se Plendil ne smije više preporučati za liječenje „vazospastične angine pektoris“ (drugog tipa angine pektoris uzrokovane spazmima u krvnim žilama koje opskrbljuju srce krvlju), budući da je zaključeno da su dostupni podaci koji podržavaju ovu primjenu preograničeni.
English: The labelling and package leaflet were also revised in line with the changes to the SmPC.
Croatian: Etiketa i upute za uporabu lijeka su također pregledane u skladu s izmjenama u SPC-u.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets for Plendil should be harmonised across the EU.
Croatian: U svjetlu dostavljenih podataka i znanstvene rasprave unutar Odbora, mišljenje je CHMP-a da SPC-ovi, etiketa i upute za uporabu lijeka za lijek Plendil treba uskladiti diljem EU-a.
English: In view of this, on 12 November 2013 the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Plendil in the EU.
Croatian: Europska komisija uputila je problem CHMP-u sa ciljem usklađivanja odobrenja za stavljanje lijeka u promet za lijek Plendil u EU.
English: Oral use blister (PVC/PVDCalu/PET/paper)
Croatian: Kroz usta blister (PVC/PVDCalu/PET/papir)
English: 200 mg Film-coated tablet
Croatian: 200 mg Filmom obložena tableta
English: 3 inhalers (3 x 30 doses) (multipack)
Croatian: 3 inhalatora (3 x 30
English: It is taken by mouth once daily.
Croatian: Uzima se oralno jednom dnevno.
English: This summary was last updated in 08-2013.
Croatian: Sažetak je posljednji put obnovljen 08-2013.
English: Other information about Incresync
Croatian: Druge informacije o Incresync
English: Incresync alogliptin / pioglitazone
Croatian: Incresync alogliptin / pioglitazon
English: A risk management plan has been developed to ensure that Incresync is used as safely as possible.
Croatian: Razvijen je plan upravljanja rizikom kako bi se osiguralo da se Incresync koristi što je sigurnije moguće.
English: The full EPAR for Incresync can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za Incresync može se naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Incresync has been studied in two main studies involving 1,296 patients with type-2 diabetes that was not well controlled by previous treatment.
Croatian: Incresync je ispitan u dva glavna ispitivanja koja su obuhvatila 1.296 bolesnika sa šećernom bolešću tipa 2 koja nije dobro kontrolirana prethodnim liječenjem.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Incresync on 19 September 2013.
Croatian: Europska komisija izdaje odobrenje za stavljanje u promet koje za Incresync vrijedi na prostoru Europske unije od na 19. rujna 2013.
English: What measures are being taken to ensure the safe and effective use of Incresync?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Incresync?
English: What is Incresync and what is it used for?
Croatian: Što je Incresync i za što se koristi?
English: Alogliptin is a dipeptidyl-peptidase-4 (DPP 4) inhibitor.
Croatian: Alogliptin je inhibitor dipeptidil-peptidaze-4 (DPP 4).
English: HbA1c levels were measured after 26 weeks in the first study and 52 weeks in the second study.
Croatian: Razine HbA1c izmjerene su nakon 26 tjedana u prvom ispitivanju, te nakon 52 tjedna u drugom ispitivanju.
English: It is not intended to provide practical advice on how to use Incresync.
Croatian: Svrha sažetka nije davati praktične savjete o načinu korištenja lijeka Incresync.
English: Why is Incresync approved?
Croatian: Zašto je Incresync odobren?
English: The choice of tablet strength to start with depends on the patient's current treatment.
Croatian: Odabir jačine tablete za početak terapije ovisi o trenutnoj terapiji bolesnika.
English: Pioglitazone is authorised in the EU as Actos and associated names.
Croatian: Pioglitazon je dozvoljen za stavljanje u promet u EU pod nazivom Actos i povezanim nazivima.
English: Incresync is available as tablets (12.5 or 25 mg alogliptin and 30 mg pioglitazone; 12.5 or 25 mg alogliptin and 45 mg pioglitazone) and can only be obtained with a prescription.
Croatian: Incresync je dostupan kao tablete (12.5 ili 25 mg alogliptin i 30 mg pioglitazon; 12.5 ili 25 mg alogliptin i 45 mg pioglitazon) i izdaje se samo na liječnički recept.
English: The dose should be lowered in patients with moderately reduced kidney function.
Croatian: Doza se treba smanjiti u bolesnika s umjereno smanjenom funkcijom bubrega.
English: Incresync must not be used in patients who are hypersensitive (allergic) to the active substances or any of the ingredients or who have had serious allergic reactions to any dipeptidyl-peptidase-4 (DPP 4) inhibitor.
Croatian: Incresync ne smije se koristiti u bolesnika koji su preosjetljivi (alergični) na djelatne tvari ili bilo koji od sastojaka ili koji su imali ozbiljnu alergijsku reakciju na bilo koji inhibitor dipeptidil-peptidaze-4 (DPP
English: This is a summary of the European public assessment report (EPAR) for Incresync.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za Incresync.
English: If patients are also taking metformin, lower doses of metformin or pioglitazone may need to be given to reduce the risk of hypoglycaemia (low blood sugar levels).
Croatian: Ako bolesnici također uzimaju metformin, manje doze metformina ili pioglitazona trebaju se dati da bi se smanjio rizik od hipoglikemije (niskih razina šećera u krvi).
English: These hormones are released after a meal and stimulate the pancreas to produce insulin.
Croatian: Ovi se hormone otpuštaju nakon obroka i stimuliraju gušteraču da proizvodi inzulin.
English: Pioglitazone makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Croatian: Pioglitazon čini stanice (mast, mišiće i jetru) osjetljivijima na inzulin, što znači da tijelo bolje iskorištava inzulin kojeg proizvodi.
English: What are the risks associated with Incresync?
Croatian: Koji su rizici povezani s lijekom Incresync?
English: The most common side effects with Incresync (which may affect up to 1 in 10 people) are upper respiratory tract infections (colds), sinusitis, headache, nausea (feeling sick), dyspepsia (heartburn), abdominal pain (tummy ache), pruritus (itching), myalgia (muscle pain), peripheral oedema (swelling in arms and legs) and weight gain.
Croatian: Najčešće nuspojave lijeka Incresync (koje se mogu javiti u do 1 na 10 osoba) su infekcije gornjeg respiratornog trakta (prehlade), sinusitis, glavobolja, mučnina (osjećaj slabosti), dispepsija (žgaravica), bol u abdomenu (bol u trbuhu), pruritus (svrbež), mialgija (bol u mišićima), periferni edem (oticanje u rukama i nogama) i povećanje tjelesne težine.
English: Alogliptin is licensed in the EU as Vipidia.
Croatian: Alogliptin je dozvoljen za uporabu u EU pod nazivom Vipidia
English: It must also not be used in patients who have or have ever had heart failure or bladder cancer, those with reduced liver function, diabetic ketoacidosis (a serious condition that can occur in diabetes), or blood in the urine that has not been properly investigated.
Croatian: Ne smije se koristiti ni u bolesnika koje imaju ili su imali zatajenje srca ili rak mjehura, bolesnika s smanjenom funkcijom jetre, dijabetičkom ketoacidozom (ozbiljno stanje koje može nastupiti tijekom šećerne bolesti), ili krvi u urinu koja nije ispravno istražena.
English: It is used as an addition to diet and exercise in adults with type 2 diabetes to improve the control of blood glucose (sugar) levels:
Croatian: Koristi se kao dodatak dijeti i tjelovježbi u odraslih osoba sa šećernom bolešću tipa 2 da bi se poboljšala kontrola razina glukoze (šećera) u krvi:
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Incresync's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji odlučilo je da koristi lijeka Incresync nadmašuju s njim povezane rizike te je preporučila njegovo odobrenje za korištenje u Europskoj uniji.
English: Alogliptin does not work when the blood glucose is low.
Croatian: Alogliptin ne djeluje ako su razine glukoze niske.
English: In both studies, 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: U oba ispitivanja, glavna mjera djelotvornosti bila promjena u razini glikoziliranog hemoglobina (HbA1c), odnosno postotka hemoglobina u krvi sa spojenom glukozom.
English: The active substances in Incresync, alogliptin and pioglitazone, work in different ways to help correct this.
Croatian: Djelatne tvari u lijeku Incresync, alogliptin i pioglitazon, djeluju na različite načine pomažući da se ovo ispravi.
English: Alogliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Croatian: Alogliptin također smanjuje količinu glukoze koju proizvodi jetra tako što povećava razine inzulina i smanjuje razine hormonskog glukagona.
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: Šećerna bolest 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: For practical information about using Incresync, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Incresync, bolesnici trebaju pročitati u uputi o lijeku ili se obratiti svom liječniku ili ljekarniku.
English: What benefits of Incresync have been shown in studies?
Croatian: Koje koristi lijeka Incresync su dokazane u ispitivanjima?
English: By blocking the breakdown of Incretin hormones in the blood, alogliptin prolongs their action in stimulating the pancreas to produce more insulin when blood glucose levels are high.
Croatian: Inhibiranjem razgradnje inkretinskih hormona u krvi, alogliptin produžuje njihovo djelovanje pri stimulaciji gušterače kako bi gušterača proizvela više inzulina, ako su razine glukoze u krvi visoke.
English: • together with metformin, in patients who are not satisfactorily controlled with a combination of pioglitazone and metformin.
Croatian: • zajedno s metforminom, u bolesnika neodgovarajuće kontroliranih u kombinaciji s pioglitazonom i metforminom.
English: Both studies showed that the combination of active substances in Incresync could produce a small but clinically relevant improvement in HbA1c.
Croatian: Oba su ispitivanja pokazala da kombinacija djelatnih tvari u lijeku Incresync može proizvesti malo, ali klinički značajno poboljšanje HbA1c.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Incresync, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku za Incresync uključene su sigurnosne informacije uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: The CHMP considered that adding alogliptin to existing treatment with pioglitazone with or without metformin had shown to produce modest but clinically relevant improvements in HbA1c.
Croatian: CHMP smatra da je dodavanje alogliptina postojećoj terapiji poglitazonom s ili bez metformina rezultiralo skromnim, no klinički značajnim poboljšanjima u HbA1c.
English: Incresync can also be used as a replacement tablet (supplying both alogliptin and pioglitazone) in patients who are already being treated with alogliptin and pioglitazone given separately.
Croatian: Incresync može se također koristiti kao zamjenska tableta (isporučuje alogliptin i pioglitazon) u bolesnika koji se već liječe zasebno alogliptinom i pioglitazonom.
English: Regarding safety, Incresync's safety profile was consistent with that seen with the individual components.
Croatian: Vezano uz sigurnost, sigurnosni profil lijeka Incresync sukladan je s profilima utvrđenima za pojedinačne sastojke.
English: It works by blocking the breakdown of ‘incretin' hormones in the body.
Croatian: Djeluje inhibirajući razgradnju inkretinskih hormona u tijelu.
English: One of the studies compared the effects of alogliptin with placebo (a dummy treatment) when used as an add-on to existing treatment with pioglitazone (the same combination as in Incresync), with or without metformin or another diabetes medicine.
Croatian: Jedno od ispitivanja usporedilo je djelovanje alogliptina s placebom (lažnim liječenjem) koji se koristio kao dodatak uz postojeće liječenje pioglitazonom (ista kombinacija kao i u lijeku Incresync), s ili bez metformina ili drugog lijeka protiv šećerne bolesti.
English: For more information about treatment with Incresync, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju Incresync pročitajte u uputi o lijeku (također dio EPARa) ili se obratite svom liječniku ili ljekarniku.
English: When added to pioglitazone, the improvement was a fall of 0.47% at a dose of alogliptin of 12.5 mg, and 0.61% for alogliptin 25 mg. Incresync was at least as effective as pioglitazone and metformin in reducing HbA1c.
Croatian: Ako se doda u pioglitazon, poboljšanje je bio pad od 0,47% pri dozi alogliptina od 12,5 mg, i 0,61% za alogliptin od 25 mg.
English: If patients were previously taking pioglitazone and alogliptin separately, Incresync should be used in a strength that continues to provide the same doses.
Croatian: Ako su bolesnici prethodno uzimali zasebno pioglitazon i alogliptin, Incresync se treba koristiti u jačini koja i dalje pruža iste doze.
English: The CHMP therefore considered that the combination of alogliptin and pioglitazone in Incresync is of benefit to patients.
Croatian: Stoga CHMP smatra da je kombinacija alogliptina i pioglitazona u lijeku Incresync od koristi za bolesnike.
English: If patients were previously taking pioglitazone alone, the strength of Incresync that provides the same dose of pioglitazone should be used.
Croatian: Ako su bolesnici prethodno uzimali samo pioglitazon, treba se primijeniti Incresync jačine koja pruža istu dozu pioglitazona.
English: Incresync is a diabetes medicine containing the active substances alogliptin and pioglitazone.
Croatian: Incresync je antidijabetik koji sadrži djelatne tvari alogliptin i pioglitazon.
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: Kao rezultat djelovanja obje djelatne tvari, razine glukoze u krvi su smanjene, te to pomaže pri kontroli šećerne bolesti tipa 2.
English: In the other study the effects of adding alogliptin to existing treatment with pioglitazone and metformin was compared with increasing the doses of pioglitazone.
Croatian: U drugom ispitivanju uspoređeno je djelovanje dodavanja alogliptina postojećem liječenju s pioglitazonom i metforminom s povećanjem doza pioglitazona.
English: Together, these processes reduce blood glucose levels and help to control type-2 diabetes.
Croatian: Zajedno ovi procesi smanjuju razine glukoze u krvi i pomažu pri kontroli šećerne bolesti tipa
English: How is Incresync used?
Croatian: Kako se Incresync koristi?
English: In addition, the company that markets Incresync will produce educational materials for doctors prescribing the medicine, which will cover the possible risk of heart failure and bladder cancer with treatments that contain pioglitazone, the criteria for selecting patients and the need to review treatment regularly and stop treatment if patients are no longer benefiting.
Croatian: Ovi materijali trebaju navesti informacije o riziku od zatajenja srca i raka mjehura u slučaju liječenja koje sadrži pioglitazon, kriteriju za odabir bolesnika i potrebi za redovitom kontrolom terapije te prekidom terapije, ako bolesnici više ne osjećaju koristi.