FrancophonIA/ELRC3.0 huggingface dataset:
English: PACKAGE LEAFLET Cimalgex 8 mg chewable tablets for dogs Cimalgex 30 mg chewable tablets for dogs Cimalgex 80 mg chewable tablets for dogs
Croatian: UPUTA O VMP ZA: Cimalgex, 8 mg, tablete za žvakanje za pse Cimalgex, 30 mg, tablete za žvakanje za pse Cimalgex, 80 mg, tablete za žvakanje za pse
English: • If you have any questions, speak with your doctor or pharmacist.
Croatian: • Ako imate pitanja, obratite se svom liječniku ili ljekarniku.
English: The review looked at data from several studies including:
Croatian: Pregledom su ocijenjeni podaci nekoliko ispitivanja uključujući:
English: The review of ibuprofen was initiated on 9 June 2014 at the request of the UK's medicines agency (MHRA), under Article 31 of Directive 2001/83/EC.
Croatian: Pregled ibuprofena započet je 9. lipnja 2014. na zahtjev agencije za lijekove (MHRA) Ujedinjene Kraljevine u skladu s člankom 31. Direktive 2001/83/EZ.
English: The usual dose for adults and children over 12 years of age is 200 to 400 mg, 3 or 4 times a day as needed.
Croatian: Najčešća doza za odrasle osobe i djecu stariju od 12 godina iznosi 200 do 400 mg, 3 do 4 puta na dan prema potrebi.
English: You should therefore always seek the advice of your doctor or pharmacist before using ibuprofen with aspirin.
Croatian: Stoga trebate uvijek potražiti savjet svog liječnika ili ljekarnika prije nego počnete koristiti ibuprofen s aspirinom.
English: More about the safety of NSAIDs
Croatian: Više informacija o sigurnoj primjeni NSAID-ova
English: Ibuprofen and dexibuprofen are currently available in the European Union (EU) in a number of different formulations.
Croatian: Ibuprofen i deksibuprofen trenutno su dostupni u Europskoj uniji (EU) u nizu različitih formulacija.
English: The review covered formulations for systemic use (intended to act on the whole body, such as use by mouth or by injection); it did not cover formulations such as gels or sprays applied to the skin of the affected area.
Croatian: Pregled je obuhvatio formulacije za sistemsku primjenu (predviđene da djeluju na cijelo tijelo, poput primjene kroz usta ili injekcijom); nije obuhvatio formulacije poput gelova ili sprejeva koji se primjenjuju na koži zahvaćenog područja.
English: The review was conducted by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Croatian: Pregled je proveo Odbor za procjenu rizika na području farmakovigilancije (PRAC), odbor odgovoran za procjenu sigurnosnih pitanja u pogledu lijekova za humanu primjenu, koji je iznio niz preporuka.
English: Dexibuprofen, the active enantiomer, is sometimes available on its own and is therefore included in this review.
Croatian: Deksibuprofen, aktivan enantiomer, ponekad je dostupan samostalno i stoga je uključen u ovaj pregled.
English: Risk factors include smoking, high blood pressure, diabetes and high blood cholesterol.
Croatian: Faktori rizika uključuju pušenje, visoki krvni tlak, dijabetes i visoku razinu kolesterola.
English: Ibuprofen is present in medicines as a mixture of two molecules that are enantiomers (mirror images of each other).
Croatian: Ibuprofen je prisutan u lijekovima kao mješavina dviju molekula koje su enantiomeri (zrcalne slike jedna druge).
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22. svibnja 2015. EMA/325007/2015
English: As ibuprofen medicines are all authorised nationally, the PRAC recommendations were forwarded to the Co-ordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMDh), which adopted a final position.
Croatian: Budući da su svi lijekovi koji sadrže ibuprofen odobreni na nacionalnoj razini, preporuka PRAC-a proslijeđena je Koordinacijskoj grupi za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh), koja je donijela konačnu odluku.
English: Reviews carried out in 2005, 2006, and 2012 confirmed that NSAIDs as a class are associated with a small increase in the risk of arterial thromboembolic events (blood clots in the arteries) especially in patients with underlying heart or circulatory conditions or with certain cardiovascular risk factors, and particularly if used at high doses.
Croatian: Pregledi provedeni 2005., 2006. i 2012. potvrdili su da su NSAID-ovi kao klasa povezani s manjim povećanjem rizika arterijskih tromboembolijskih događaja (krvnih ugrušaka u arterijama) posebice u bolesnika sa srčanim stanjima ili stanjima krvotoka ili s određenim faktorima kardiovaskularnog rizika, posebice ako se primjenjuju u visokim dozama.
English: A class warning of this risk is already in place and the product information for all NSAIDs, including ibuprofen, recommends that these medicines be used at the lowest effective dose and for the shortest period of time necessary to control symptoms.
Croatian: Upozorenje za klasu o tom riziku već je na snazi, a u uputama o lijeku za sve NSAID-ove, uključujući ibuprofen, preporučuje se primjena tih lijekova u najmanjoj djelotvornoj dozi te tijekom najkraćeg razdoblja potrebnog kako bi se kontrolirali simptomi.
English: • Your doctor will carefully assess you before starting treatment with high-dose ibuprofen to check if you have risk factors such as high blood pressure, high blood cholesterol, diabetes, or if you smoke.
Croatian: • Liječnik će pozorno ocijeniti Vaše stanje prije početka terapije visokom dozom ibuprofena kako bi provjerio postoje li kod Vas faktori rizika poput visokog krvnog tlaka, visokog kolesterola u krvi, dijabetesa ili jeste li pušač.
English: • The effect of duration of ibuprofen treatment on cardiovascular risk is uncertain.
Croatian: • Djelovanje trajanja terapije ibuprofenom na kardiovaskularni rizik nije izvjesno.
English: It works by blocking an enzyme called cyclooxygenase, which produces prostaglandins, substances that are involved in inflammation and pain.
Croatian: Djeluje inhibirajući enzim naziva ciklooksigenaza, koji proizvodi prostaglandine, tvari uključene u upalu i bol.
English: The safety of NSAIDs, including ibuprofen, has been reviewed regularly by authorities in the EU over the past few years.
Croatian: Sigurnu primjenu NSAID-ova, uključujući ibuprofen, redovito pregledavaju tijela unutar EU-a tijekom proteklih nekoliko godina.
English: On 20 May 2015 the CMDh adopted its position by consensus, therefore the advice recommended by the PRAC will be implemented by the Member States where the medicines are authorised, according to an agreed timetable.
Croatian: Dana 20. svibnja 2015. CMDh konsenzusom je donio svoje stajalište, stoga će se mjere koje je predložio PRAC izravno provoditi u državama članicama u kojima su lijekovi odobreni, u skladu s dogovorenim rasporedom.
English: For diclofenac, the risk was estimated at around three additional major vascular events per 1,000 participants per year.
Croatian: U slučaju diklofenaka, rizik je procijenjen na otprilike tri dodatna velika vaskularna događaja na 1 000 ispitanika godišnje.
English: Occasional use of ibuprofen should not affect the benefits of low-dose aspirin.
Croatian: Povremena primjena ibuprofena ne bi trebala utjecati na koristi niske doze aspirina.
English: In addition, doctors should carefully assess a patient's risk factors for heart or circulatory conditions before initiating long-term treatment with ibuprofen, particularly if high doses are required.
Croatian: Nadalje, liječnici trebaju pažljivo ocijeniti faktore rizika bolesnika u vezi sa srčanim stanjima ili stanjima krvotoka prije početka dugoročne terapije ibuprofenom, posebice ako su potrebne visoke doze.
English: For diclofenac, the risk was estimated at about 3 extra cases of heart attack in every 1,000 patients taking diclofenac for a year.
Croatian: U slučaju diklofenaka, rizik je procijenjen na otprilike 3 dodatna slučaja srčanog zastoja na svakih 1 000 bolesnika koji su uzimali diklofenak godinu dana.
English: Laboratory studies have shown that ibuprofen reduces the blood-thinning effects of aspirin.
Croatian: Laboratorijska su ispitivanja pokazala da ibuprofen smanjuje djelovanje aspirina kojim se razrjeđuje krv.
English: The CMDh1 has endorsed by consensus updated advice on the use of high-dose ibuprofen.
Croatian: CMDh1 je konsenzusom potvrdio ažurirani savjet o primjeni visoke doze ibuprofena.
English: • Experimental data suggest long-term use of ibuprofen/dexibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid (typically 75 mg per day).
Croatian: • Eksperimentalni podaci ukazuju na činjenicu da dugoročna primjena ibuprofena/deksibuprofena može smanjiti djelovanje niske doze acetilsalicilne kiseline koje štiti srce (najčešće 75 mg na dan).
English: Ibuprofen and dexibuprofen medicines have been authorised in the EU through national approval procedures and have been available for many years under a wide range of trade names.
Croatian: Lijekovi koji sadrže ibuprofen i deksibuprofen odobreni su u EU-u nacionalnim postupcima i dostupni su mnogo godina pod različitim trgovačkim nazivima.
English: A dose of 2,400 mg per day of ibuprofen is equivalent to 1,200 mg per day of dexibuprofen.
Croatian: Doza ibuprofena od 2 400 mg na dan ekvivalentna je dozi deksibuprofena od 1 200 mg na dan.
English: • Patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus and smoking) should only be treated with high-dose ibuprofen after careful consideration.
Croatian: • Bolesnici s faktorima rizika kardiovaskularnih događaja (kao što su, primjerice, hipertenzija, hiperlipidemija, dijabetes melitus i pušenje) trebaju se liječiti visokim dozama ibuprofena tek nakon pažljivog razmatranja.
English: The CMDh is a body representing EU Member States as well as Iceland, Liechtenstein and Norway.
Croatian: CMDh je regulatorno tijelo za lijekove koje zastupa države članice Europske unije (EU), Island, Lihtenštajn i Norvešku.
English: • High doses of ibuprofen should be avoided in patients with cardiovascular conditions (e.g. uncontrolled hypertension, congestive heart failure (NYHA class II-III), established ischaemic heart disease, peripheral arterial disease and cerebrovascular disease).
Croatian: • Visoke doze ibuprofena treba izbjegavati u bolesnika s kardiovaskularnim stanjima (primjerice nekontroliranom hipertenzijom, kongestivnim zatajenjem srca (NYHA klase II-III), utvrđenom ishemijskom srčanom bolešću, perifernom arterijskom bolešću i cerebrovaskularnom bolešću).
English: Updated advice on use of high-dose ibuprofen
Croatian: Ažurirani savjet o primjeni visoke doze ibuprofena
English: No clinically relevant effect is considered to be likely for occasional ibuprofen use.
Croatian: Smatra se da nema klinički relevantnog djelovanja u slučaju povremene primjene ibuprofena.
English: This is because ibuprofen may competitively inhibit the effect of low dose acetylsalicylic acid on platelet aggregation when they are used concomitantly.
Croatian: Razlog tomu je što ibuprofen može u potpunosti inhibirati djelovanje niske doze acetilsalicilne kiseline na nakupljanje tromba ako se koriste istovremeno.
English: The updated advice on the cardiovascular risk of high-dose ibuprofen will be included in the product information of ibuprofen medicines, along with information on the interaction between ibuprofen and aspirin.
Croatian: Ažurirani savjet o kardiovaskularnom riziku visoke doze ibuprofena bit će uključen u uputu o lijeku za lijekove koji sadrže ibuprofen, zajedno s informacijama o interakciji između ibuprofena i aspirina.
English: To minimise the cardiovascular risk, high doses of ibuprofen (2,400 mg per day or higher) should be avoided in patients with serious underlying heart or circulatory conditions, such as heart failure, heart disease and circulatory problems or in those who have previously had a heart attack or stroke.
Croatian: Kako bi se smanjio kardiovaskularni rizik, treba izbjegavati visoke doze ibuprofena (2 400 mg na dan ili više) u bolesnika s ozbiljnim srčanim stanjima ili stanjima krvotoka, poput zatajenja srca, srčane bolesti i problema s cirkulacijom ili u osoba koje su prethodno preboljele srčani ili moždani udar.
English: No risk has been seen with ibuprofen at doses up to 1,200 mg per day, which is the highest dose usually taken by the majority of patients.
Croatian: Nije uočen nikakav rizik povezan s ibuprofenom u dozama do 1 200 mg na dan, što je ujedno i najveća uobičajena doza koju uzima većina bolesnika.
English: • Use of high-dose ibuprofen is no longer recommended if you have heart or circulatory conditions, such as heart failure, heart disease and circulatory problems or if you have previously had a heart attack or stroke.
Croatian: • Primjena visoke doze ibuprofena više se ne preporuča ako bolujete od srčanih stanja ili stanja krvotoka, poput zatajenja srca, srčane bolesti i imate problema s cirkulacijom ili ako ste prethodno imali srčani ili moždani udar.
English: Review confirms small cardiovascular risk with daily doses at or above 2,400 mg
Croatian: Pregledom je potvrđen mali kardiovaskularni rizik s dnevnim dozama jačine 2 400 mg ili više
English: This latest review considered accumulated evidence which clarifies the cardiovascular risk related to ibuprofen taken at high doses and the interaction between ibuprofen at any dose and aspirin.
Croatian: Najnoviji pregled razmotrio je prikupljene dokaze koji pojašnjavaju kardiovaskularni rizik povezan s ibuprofenom koji se uzima u visokim dozama i interakciju između ibuprofena u bilo kojoj dozi i aspirina.
English: Ibuprofen is a painkiller and anti-inflammatory medicine that belongs to the class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Croatian: Ibuprofen je analgetik i protuupalni lijek koji se ubraja u klasu lijekova naziva nesteroidni protuupalni lijekovi (NSAID).
English: • Although no specific data about the cardiovascular risk with dexibuprofen are available, a similar cardiovascular risk to that with high-dose of ibuprofen is expected when dexibuprofen is used at equipotent doses (at or above 1,200 mg per day).
Croatian: • Iako nema dostupnih podataka o kardiovaskularnom riziku povezanom s deksibuprofenom, kardiovaskularni rizik sličan onom koji je povezan s visokom dozom ibuprofena očekuje se kada se deksibuprofen koristi u ekvipotentnim dozama (od 1 200 mg na dan ili više).
English: As the CMDh has now agreed the PRAC advice by consensus, changes to the product information for ibuprofen- and dexibuprofen-containing medicines will be implemented by the Member States where the medicines are authorised, according to an agreed timetable.
Croatian: Budući da je CMDh sada konsenzusom odobrio PRAC-ov savjet, izmjene upute o lijeku za lijekove koji sadrže ibuprofen i deksibuprofen provodit će se u skladu s dogovorenim rasporedom izravno u državama članicama u kojima su lijekovi odobreni.
English: • Prolonged use of ibuprofen may reduce the effect of low-dose aspirin when the latter is taken to reduce the risk of heart attacks and strokes.
Croatian: • Produljena uporaba ibuprofena može smanjiti djelovanje niske doze aspirina ako se potonje uzima s ciljem smanjivanja rizika od srčanog i moždanog udara.
English: However, it remains uncertain whether longterm use of ibuprofen in clinical practice reduces the benefits of low-dose aspirin in preventing heart attacks and strokes.
Croatian: No, nije sigurno smanjuje li dugoročna primjena ibuprofena u kliničkoj praksi koristi niske doze aspirina u sprječavanju srčanih i moždanih udara.
English: They are available on prescription and over the counter.
Croatian: Izdaju se na liječnički recept i bez liječničkog recepta.
English: The review also looked at data on the interaction between ibuprofen and low-dose aspirin when the latter is taken to reduce the risk of heart attacks and strokes.
Croatian: Pregledom su također provjereni podaci o interakciji između ibuprofena i niske doze aspirina ako se potonji uzima za smanjenje rizika od srčanih i moždanih udara.
English: No increase in cardiovascular risk is seen with ibuprofen at doses of up to 1,200 mg per day, which is the highest dose generally used for over-the-counter (OTC) preparations taken by mouth in the European Union (EU).
Croatian: Nije uočeno nikakvo povećanje kardiovaskularnog rizika pri primjeni ibuprofena u dozama do 1 200 mg na dan, što je najveća doza koja se načelno koristi u Europskoj uniji (EU) za pripravke koji se izdaju bez liječničkog recepta (OTC-ove) i uzimaju peroralno.
English: • Data from meta-analyses and epidemiological studies indicate that there is an increased risk of cardiovascular events (such as myocardial infarction or stroke) associated with the use of highdose ibuprofen (at or above 2,400 mg per day).1-4
Croatian: • Podaci prikupljeni iz meta analiza i epidemioloških ispitivanja ukazuju da postoji povišen rizik od kardiovaskularnih događaja (poput infarkta miokarda ili moždanog udara) povezan s primjenom visoke doze ibuprofena (od 2 400 mg na dan ili više).1-4
English: Salvo F, Fourrier-Reglat A, Bazin F, et al. Cardiovascular and gastrointestinal safety of NSAIDs: a systematic review of meta-analyses of randomized clinical trials.
Croatian: Cardiovascular and gastrointestinal safety of NSAIDs: a systematic review of meta-analyses of randomized clinical trials.
English: This follows a review carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), which confirmed a small increased risk of cardiovascular problems, such as heart attacks and strokes, in patients taking high doses of ibuprofen (at or above 2,400 mg per day).
Croatian: Ta je potvrda uslijedila nakon pregleda koji je proveo Odbor za ocjenu rizika na području farmakovigilancije (PRAC) pri EMA-i, a kojim je potvrđeno malo povećanje rizika od kardiovaskularnih problema, poput srčanog i moždanog udara, u bolesnika koji uzimaju visoke doze ibuprofena (jačine od 2 400 mg na dan ili više).
English: Bhala N, Emberson J, Merhi A, et al. Vascular and upper gastrointestinal effects of nonsteroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials.
Croatian: Vascular and upper gastrointestinal effects of nonsteroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials.
English: It followed concerns that high doses of ibuprofen could have a similar cardiovascular risk to that of COX-2 inhibitors and diclofenac.
Croatian: Postupak je proveden nakon iznošenja zabrinutosti da visoke doze ibuprofena mogu imati učinak na kardiovaskularni rizik sličan onom koji proizvode COX-2 inhibitori i diklofenak.
English: • An EU-wide review of ibuprofen has confirmed that there is a small risk of heart attacks and strokes in patients taking high doses of the medicine (at or above 2,400 mg per day).
Croatian: • Pregled ibuprofena proveden diljem EU-a potvrdio je kako je prisutan mali rizik od srčanih i moždanih udara u bolesnika koji uzimaju visoke doze lijeka (jačine 2 400 na dan ili više).
English: • The risk with high-dose ibuprofen is similar to the risk seen with some other non-steroidal antiinflammatory drugs (NSAIDs), including COX-2 inhibitors and diclofenac.
Croatian: • Rizik visoke doze ibuprofena sličan je riziku koji je uočen pri primjeni nekih drugih nestereoidnih protuupalnih lijekova (NSAID-ova), uključujući COX-2 inhibitore i diklofenak.
English: Olsen AM, Fosbol EL, Lindhardsen J, et al. Cause-specific cardiovascular risk associated with nonsteroidal anti-inflammatory drugs among myocardial infarction patients--a nationwide study.
Croatian: Cause-specific cardiovascular risk associated with nonsteroidal anti-inflammatory drugs among myocardial infarction patients--a nationwide study.
English: The review clarifies that the risk with highdose ibuprofen is similar to the risk seen with some other non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors and diclofenac.
Croatian: Pregledom je potvrđeno kako je rizik od visoke doze ibuprofena sličan riziku koji je uočen pri primjeni nekih drugih nesteroidnih protuupalnih lijekova (NSAID-ova), uključujući inhibitore ciklooksigenaze 2 (COX-2) i diklofenak.
English: The capsules should be swallowed whole with water.
Croatian: Kapsule treba progutati cijeli s vodom.
English: It is used to treat adults with the following conditions:
Croatian: Koristi se za liječenje odraslih osoba sa sljedećim stanjima:
English: This summary was last updated in 04-2014.
Croatian: Sažetak je posljednji put ažuriran: 04-2014.
English: This medicine is the same as Lyrica, which is already authorised in the European Union (EU).
Croatian: Ovaj je lijek isti kao Lyrica, koji je već odobren u Europskoj uniji (EU).
English: The medicine can only be obtained with a prescription and is available as capsules (25, 50, 75, 100, 150, 200, 225 and 300 mg).
Croatian: Ovaj se lijek izdaje samo na liječnički recept i dostupan je u kapsulama (25, 50, 75, 100, 150, 200, 225 i 300 mg).
English: Doses can be increased up to twice more until the most effective dose is reached.
Croatian: Doze se mogu također povećati dvaput ili više sve dok se ne dosegne učinkovita doza.
English: • generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).
Croatian: • generaliziranim anksioznim poremećajem (dugoročna tjeskoba ili nervoza povezana sa svakodnevnicom).
English: Patients who have kidney problems need to take lower doses.
Croatian: Bolesnici koji imaju problema s bubrezima moraju uzimati manje doze.
English: • epilepsy, where it is used as an ‘add-on' to existing treatment in patients who have partial seizures (epileptic fits starting in one specific part of the brain) that cannot be controlled with their current treatment;
Croatian: • epilepsijom, kada se koristi kao dodatak postojećoj terapiji u bolesnika koji imaju djelomične napadaje (epileptičke napadaje u određenom dijelu mozga) koji se ne mogu kontrolirati aktualnom terapijom;
English: This compared with about 10% of the patients taking placebo.
Croatian: Za usporedbu s 10% bolesnika koji su uzimali placebo.
English: The full EPAR and risk management plan summary for Pregabalin Pfizer 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 lijek Pregabalin Pfizer nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This reduces the activity of some of the nerve cells in the brain and spinal cord, reducing the release of other neurotransmitters that are involved in pain, epilepsy and anxiety.
Croatian: Na ovaj se način smanjuje aktivnost pojedinih živčanih stanica u mozgu i kralježničnoj moždini, čime se smanjuje otpuštanje neurotransmitera, koji su uključeni u osjećaj boli, epilepsije i anksioznosti.
English: The exact way that pregabalin works is not fully understood, but it is thought to affect the way that calcium enters nerve cells.
Croatian: Nije u potpunosti jasan točan način djelovanja pregabalina, no smatra se da utječe na način na koji kalcij ulazi u stanice.
English: The active substance in Pregabalin Pfizer, pregabalin, is similar in structure to the body's own ‘neurotransmitter' gamma-amino butyric acid (GABA), but has very different biological effects.
Croatian: Djelatna tvar lijeka Pregabalin Pfizer, pregabalin, slične je strukture kao vlastiti „neurotransmiter” tijela gama-aminomaslačna kiselina (GABA), no ima vrlo drugačije biološko djelovanje.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pregabalin Pfizer on 10 April 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Pregabalin Pfizer vrijedi na prostoru Europske unije od 10. travnja 2014.