FrancophonIA/ELRC3.0 huggingface dataset:
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Yellox have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Yellox nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: It is not intended to provide practical advice on how to use Yellox.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Yellox.
English: It works by blocking an enzyme called cyclo-oxygenase, which produces prostaglandins, substances that are involved in the inflammation process.
Croatian: Djeluje blokirajući enzim naziva ciklooksigenaza koji proizvodi prostaglandine, tvari uključene u upalni proces.
English: By reducing the production of prostaglandins in the eye, Yellox can reduce the inflammation caused by eye surgery.
Croatian: Smanjenjem količine prostaglandina u oku Yellox može ublažiti upalu uzrokovanu operacijom oka.
English: In the second study, the figures were: 63% (124 out of 198) for patients treated with Yellox and 40% (39 out of 98) for those treated with placebo.
Croatian: U drugom su ispitivanju rezultati bili 63 % (124 od 198) kod bolesnika koji su uzimali Yellox, u odnosu na 40 % bolesnika (39 od 98) koji su uzimali placebo.
English: What are the risks associated with Yellox?
Croatian: Koji su rizici povezani s lijekom Yellox?
English: It must not be used in patients who get asthma attacks, urticaria (itchy rash) or acute rhinitis (stuffy and runny nose) from taking acetylsalicylic acid (aspirin) or other NSAIDs.
Croatian: Ne smije ga se koristiti u bolesnika koji dobivaju astmatične napade, urtikariju (osip koji svrbi) ili akutni rinitis (začepljeni nos ili nos koji curi) nakon uzimanja acetilsalicilne kiseline (aspirina) ili drugih NSAIL-ova.
English: Yellox is available as an eye drop solution and the recommended dose is one drop into the affected eye(s) twice a day.
Croatian: Yellox je dostupan kao otopina za oči, a preporučena doza je jedna kapljica u upaljeno oko dva puta dnevno.
English: Yellox must not be used in people who are hypersensitive (allergic) to bromfenac, to any of the other ingredients or to other NSAIDs.
Croatian: Lijek Yellox ne smiju uzimati osobe preosjetljive (alergične) na bromfenak, na bilo koji drugi sastojak lijeka ili na druge NSAIL-ove.
English: The active substance in Yellox, bromfenac, is a non-steroidal anti-inflammatory drug (NSAID).
Croatian: Djelatna tvar u lijeku Yellox, bromfenak, nesteroidni je protuupalni lijek (NSAIL).
English: For more information about treatment with Yellox, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Yellox pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: Yellox is a medicine used in adults to treat inflammation in the eye that can occur after an operation to remove a cataract (clouding of the lens).
Croatian: Yellox je lijek za liječenje upale u oku odraslih osoba koja se može pojaviti nakon operacije katarakta (zamućenja leće).
English: For more information see the package leaflet.
Croatian: Za dodatne informacije vidjeti uputu o lijeku.
English: For practical information about using Yellox, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Yellox bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
English: What benefits of Yellox have been shown during the studies?
Croatian: Koje su koristi od lijeka Yellox utvrđene u ispitivanjima?
English: How does Yellox work?
Croatian: Kako djeluje Yellox?
English: How is Yellox used?
Croatian: Kako se Yellox koristi?
English: Yellox contains the active substance bromfenac.
Croatian: Yellox sadrži djelatnu tvar bromfenak.
English: For the full list of all side effects reported with Yellox, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Yellox potražite u uputi o lijeku.
English: Yellox was found to be more effective than placebo (a dummy treatment) at relieving inflammation in the eye following cataract surgery in two main studies involving a total of 527 patients undergoing cataract surgery.
Croatian: U dvama glavnim ispitivanjima kojima je bilo obuhvaćeno ukupno 527 osoba koje su prošle operaciju katarakta, utvrđeno je da je lijek Yellox bio djelotvorniji od placeba (prividnog liječenja) pri
English: This summary was last updated in July 2013.
Croatian: Sažetak je posljednji put dopunjen u srpnju 2013.
English: Melovem must also not be used in horses less than 6 weeks of age.
Croatian: Melovem se također ne smije koristiti za konje mlađe od 6 tjedana.
English: If someone accidentally injects themselves with the medicine, the advice of a doctor should be sought immediately.
Croatian: Ako si netko slučajno ubrizga lijek, potrebno je odmah potražiti savjet liječnika.
English: Other information about Melovem:
Croatian: Druge informacije o proizvodu Melovem:
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Melovem on 7 July 2009.
Croatian: Europska komisija dodijelila je odobrenje za stavljanje u promet koje je na snazi na teritoriju Europske unije za proizvod Melovem dana 7. srpnja 2009.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Croatian: Dva su lijeka bioekvivalentna kada stvaraju istu razinu djelatne tvari u tijelu.
English: The product is not authorised for use in horses producing milk for human consumption.
Croatian: Proizvod nije odobren za upotrebu kod konja od kojih se dobiva mlijeko za ljudsku potrošnju.
English: If used for the treatment of diarrhoea in cattle, Melovem must not be used in animals of less than one week of age.
Croatian: Ako se koristi za liječenje proljeva u stoke, Melovem se ne smije koristiti u životinja mlađih od tjedan dana.
English: In very rare cases, potentially serious or fatal anaphylactoid reactions (similar to severe allergic reactions) may occur following injection and should be treated symptomatically.
Croatian: U vrlo rijetkim slučajevima mogu se javiti potencijalno ozbiljne ili smrtonosne anafilaktoidne reakcije (slične teškim alergijskim reakcijama) nakon injekcije i treba ih liječiti simptomatski.
English: People who are hypersensitive (allergic) to NSAIDs should avoid contact with Melovem.
Croatian: Osobe koje su preosjetljive (alergične) na nesteroidne protuupalne lijekove trebaju izbjegavati kontakt s Melovemom.
English: It must not be used in animals which are hypersensitive (allergic) to the active substance or any of the other ingredients.
Croatian: Ne smije se koristiti u životinja koje su preosjetljive (alergične) na djelatnu tvar ili na bilo koji drugi sastojak.
English: This means that Melovem is similar to a ‘reference veterinary medicine' containing the same active substance.
Croatian: To znači da je Melovem sličan „referentnom veterinarsko-medicinskom proizvodu” koji sadrži istu djelatnu tvar.
English: Therefore, the CVMP's view was that, as for Metacam, Melovem's benefits are greater than its risks for the approved indications and the Committee recommended that Melovem be given a marketing authorisation.
Croatian: Stajalište CVMP-a, baš kao i u slučaju Metacama, bilo je da su koristi Melovema veće od njegovih rizika za odobrene indikacije i Povjerenstvo je preporučilo izdavanje odobrenja za stavljanje u promet za Melovem.
English: What is the risk associated with Melovem?
Croatian: Koji su rizici povezani s proizvodom Melovem?
English: Information on the prescription status of this product may be found on the label/outer package.
Croatian: Informacije o tome je li za ovaj proizvod potreban veterinarski recept možete pronaći na etiketi/vanjskom pakiranju.
English: The CVMP decided that, in accordance with European Union requirements, Melovem has been shown to be bioequivalent to Metacam.
Croatian: CVMP je odredio da je u skladu sa zahtjevima Europske unije dokazano da je Melovem bioekvivalentan Metacamu.
English: This document is a summary of the European Public Assessment Report.
Croatian: Ovaj je dokument sažetak Europskoga javnog izvješća o procjeni veterinarsko-medicinskog proizvoda.
English: It is available as a solution for injection (5 mg/ml, 20 mg/ml and 30 mg/ml).
Croatian: Dostupan je kao otopina za injekcije (5 mg/ml, 20 mg/ml i 30 mg/ml).
English: A slight temporary swelling at the injection site following injection under the skin and in the muscle was observed in cattle and pigs.
Croatian: Blago prolazno oticanje na mjestu injekcije nakon potkožne injekcije i u mišić uočeno je kod stoke i prasadi.
English: In horses, a temporary swelling at the injection site can occur but resolves without intervention.
Croatian: Kod konja se privremeno oticanje može javiti, ali se rješava bez liječenja.
English: Why has Melovem been approved?
Croatian: Zašto je Melovem odobren?
English: As Melovem is considered to be bioequivalent to the reference medicine, its benefit is taken as being the same as that of the reference medicine.
Croatian: S obzirom na to da se Melovem smatra bioekvivalentnim referentnom lijeku, smatra se da su njegove koristi jednake onima od referentnog lijeka.
English: It can be used in combination with oral rehydration therapy (medicines given by mouth to restore water levels in the body) for diarrhoea in calves of over one week of age and young, non-lactating cattle.
Croatian: Može se koristiti u kombinaciji s oralnom rehidratacijskom terapijom (lijekovima koji se daju na usta kako bi se povratila razina vode u tijelu) za liječenje proljeva kod teladi starije od tjedan dana i mlađe stoke koja nije u laktaciji.
English: Meloxicam acts by blocking an enzyme called cyclo-oxygenase which is involved in the production of prostaglandins.
Croatian: Meloksikam djeluje blokadom enzima nazvanog ciklooksigenaza koja je uključena u proizvodnju prostaglandina.
English: As prostaglandins are substances that trigger inflammation, pain, exudation (fluid that leaks out of blood vessels during an inflammation) and fever, meloxicam reduces these signs of disease.
Croatian: S obzirom na to da su prostaglandini tvari koje potiču upalu, bol, eksudaciju (tekućina koja curi iz krvnih žila tijekom upale) i vrućicu, meloksikam smanjuje ove znakove bolesti.
English: It is also the time allowed after administration of the medicine before the milk can be used for human consumption.
Croatian: To je također vrijeme koje treba proći nakon primjene lijeka prije nego što ljudi smiju konzumirati mlijeko.
English: Melovem contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Croatian: Melovem sadrži meloksikam, koji pripada skupini lijekova zvanih nesteroidni protuupalni lijekovi (NSAIDs).
English: Melovem is used in cattle, together with appropriate antibiotic therapy, to reduce the signs of acute respiratory infections (infection of the lung and airways).
Croatian: Melovem se koristi za stoku, zajedno s odgovarajućom terapijom antibioticima kako bi se smanjili znakovi akutnih respiratornih infekcija (infekcije pluća i dišnih putova).
English: Melovem must not be used in animals with liver, heart or kidney problems, bleeding disorders, or suffering from irritation or ulcers of the digestive tract.
Croatian: Melovem se ne smije koristiti kod životinja s problemima jetre, srca ili bubrega, s poremećajima krvarenja ili onih koje pate od iritacije ulkusa u probavnom traktu.
English: Studies have been carried out, both in calves and in pigs, to show that Melovem is bioequivalent to the reference medicine, Metacam.
Croatian: Ispitivanja su provedena kako na teladi, tako i na svinjama kako bi se pokazalo da je Melovem bioekvivalentan referentnom lijeku Metacamu.
English: What is Melovem used for?
Croatian: Za što se Melovem koristi?
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption or eggs or milk used for human consumption.
Croatian: Karencija je dopušteno razdoblje koje treba proći nakon primjene lijeka, a prije nego što se životinja smije zaklati te njeno meso, mlijeko ili jaja koristiti za prehranu čovjeka.
English: Melovem solution for injection (5 mg/ml, 20 mg/ml and 30 mg/ml) is used in pigs to reduce the symptoms of lameness (inability to walk normally) and inflammation in non-infectious locomotor disorders (diseases that affect the ability to move).
Croatian: Melovem otopina za injekciju (5 mg/ml, 20 mg/ml i 30 mg/ml) koristi se kod svinja za smanjivanje simptoma šepavosti (nemogućnosti normalnog hodanja) i upale kod neinfektivnih lokomotornih poremećaja (bolesti koje zahvaćaju sposobnost kretanja).
English: What benefit has Melovem shown during the studies?
Croatian: Koje su koristi Melovema utvrđene tijekom ispitivanja?
English: Melovem is a medicine that contains the active substance meloxicam.
Croatian: Melovem je lijek koji sadrži djelatnu tvar meloksikam.
English: What is Melovem?
Croatian: Što je Melovem?
English: Melovem is a ‘generic'.
Croatian: Melovem je generički lijek.
English: The 20 mg/ml and 30 mg/ml solution for injection can be used together with appropriate antibiotic therapy for the treatment of diseases that occur after farrowing (giving birth) such as puerperal septicaemia (bacteria present in blood) and toxaemia (a toxic state) (mastitismetritis-agalactia syndrome).
Croatian: Otopina za injekciju od 20 mg/ml i 30 mg/ml može se koristiti zajedno s odgovarajućom terapijom antibioticima za liječenje bolesti koje se javljaju nakon prasenja poput puerperalne septikemije (bakterija u krvi) i toksemije (toskičnog stanja) (sindroma mastitisa-metritisa-agalaktije).
English: Melovem solution for injection (20 mg/ml) is used in horses to relieve colic (abdominal pain) and the inflammation and pain in musculo-skeletal disorders.
Croatian: Melovem otopina za injekciju (20 mg/ml) koristi se kod konja za olakšavanje kolika (bolova u trbuhu), upale i boli kod mišićno-koštanih poremećaja.
English: While the reference medicine, Metacam, is available as 5 mg/ml and 20 mg/ml solutions for injection, Melovem is also available as a 30 mg/ml solution for injection.
Croatian: Dok je referentni lijek Metacam dostupan kao otopina za injekciju od 5 mg/ml i 20 mg/ml, Melovem je također dostupan kao otopina za injekciju jačine 30 mg/ml.
English: The 5 mg/ml solution for injection can be used for the relief of post-operative pain associated with minor soft tissue surgery such as castration (surgical removal of the testicles).
Croatian: Agencija Europske unije koristiti za ublažavanje postoperativne boli povezane s manjim kirurškim zahvatom na mekom tkivu poput kastracije (kirurško odstranjenje testisa).
English: How does Melovem work?
Croatian: Kako Melovem djeluje?
English: The 20 mg/ml and 30 mg/ml solutions for injection are also used in combination with antibiotic therapy to treat acute mastitis (inflammation of the udder).
Croatian: Otopine za injekciju od 20 mg/ml i 30 mg/ml također se koriste u kombinaciji s terapijom antibioticima za liječenje akutnog mastitisa (upale vimena).
English: How has Melovem been studied?
Croatian: Kako se Melovem ispitivao?
English: Number (%)
Croatian: Broj (%)
English: Relative risk reduction (95% CI)
Croatian: Smanjenje relativnog rizika (95% CI)
English: Date of latest renewal: 17 April 2014
Croatian: Datum posljednje obnove: 17. travnja 2014.
English: You can take the tablet at any time of the day, with or without food.
Croatian: Tabletu možete uzeti u bilo koje doba dana, s hranom ili bez nje.
English: This leaflet was last revised in {MM/YYYY}.
Croatian: Uputa je zadnji puta revidirana u {MM/GGGG}.
English: Date of first authorisation: 17 April 2009
Croatian: Datum prvog odobrenja: 17. travnja 2009.
English: The clinical relevance of these changes has not been established.
Croatian: Nije utvrđen klinički značaj tih promjena.
English: In the case of overdose, there is no specific antidote, and treatment should be symptomatic.
Croatian: U slučaju predoziranja ne postoji specifičan antidot i liječenje treba biti simptomatsko.
English: This lipid profile was maintained throughout the 7 years of treatment.
Croatian: Ovakav lipidni profil održao se tijekom svih sedam godina liječenja.
English: While very infrequent, these clots can cause serious medical problems, disability or death.
Croatian: Iako se ne javljaju jako često, ti ugrušci mogu izazvati ozbiljne zdravstvene probleme, invaliditet ili smrt.
English: The above are some reasons why this product may not be suitable for you.
Croatian: Ovo su neki od razloga zbog kojih ovaj lijek možda neće biti prikladan za Vas.
English: What CONBRIZA is and what it is used for
Croatian: Što je CONBRIZA i za što se koristi
English: However, if it is almost time to take your next dose of this medicine, skip the dose you missed and only take your next scheduled dose.
Croatian: Međutim, ako je uskoro vrijeme za sljedeću dozu ovog lijeka, preskočite propuštenu dozu i uzmite samo sljedeću dozu po rasporedu.
English: This medicine contains lactose (a type of sugar).
Croatian: Ovaj lijek sadrži laktozu (vrstu šećera).
English: The recommended dose of CONBRIZA is one tablet once daily, at any time of day, with or without food (see section 5.2).
Croatian: Preporučena doza lijeka CONBRIZA je jedna tableta jedanput na dan, u bilo koje doba dana, s hranom ili bez nje (vidjeti dio 5.2).
English: In order for this medicine to treat osteoporosis, it must be taken daily.
Croatian: Kako bi ovaj lijek mogao liječiti osteoporozu, morate ga uzimati svakodnevno.
English: Other medicines and CONBRIZA
Croatian: Drugi lijekovi i CONBRIZA
English: Doses higher than 20 mg are not recommended because there is no demonstrable increased efficacy and higher doses may be associated with additional risk (see section 5.1).
Croatian: Doze veće od 20 mg se ne preporučuju jer nema dokaza povećane djelotvornosti, a veće doze mogu biti povezane s dodatnim rizikom (vidjeti dio 5.1).
English: This medicine should not be used for the treatment of osteoporosis in men.
Croatian: Ovaj lijek se ne smije koristiti za liječenje osteoporoze u muškaraca.
English: Speak with your doctor to see if you are at increased risk for blood clots.
Croatian: Porazgovarajte s liječnikom da utvrdite imate li povećan rizik od krvnih ugrušaka.
English: It must not be taken by women who are pregnant or who could still have a baby.
Croatian: Ne smiju ga uzimati trudnice niti žene koje još uvijek mogu zatrudnjeti.
English: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Croatian: Obavijestite liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli bilo koje druge lijekove.
English: Multiple dose 20 mg/day 6.2 ± 2.2 1.7 ± 1.8 28 ± 11 82 ± 37 4.1 ± 1.7
Croatian: Višestruke doze 20 mg na dan 6,2 ± 2,2 1,7 ± 1,8 28 ± 11 82 ± 37 4,1 ± 1,7
English: If you decide to stop taking this medicine before finishing the prescribed course of treatment, you should talk to your doctor first.
Croatian: Odlučite li prestati uzimati ovaj lijek prije nego što ste dovršili propisani ciklus liječenja, najprije o tome morate razgovarati s liječnikom.
English: Other venous thromboembolic events could also occur.
Croatian: Mogu nastupiti i drugi tromboembolijski događaji.
English: Elderly patients
Croatian: Starije bolesnice
English: This is because sitting for a long time in the same position may prevent good blood circulation and may increase your risk of blood clots.
Croatian: To je zato što dugotrajno sjedenje u istom položaju može oslabiti cirkulaciju krvi i povećati rizik od stvaranja krvnih ugrušaka.
English: Adverse reactions are categorized according to the following frequencies: very common ( 1/10); common ( 1/100 to  1/10); uncommon ( 1/1,000 to  1/100); rare ( 1/10,000 to  1/1,000); not known (cannot be estimated from the available data).
Croatian: Nuspojave su kategorizirane prema sljedećoj učestalosti: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000); nije poznato (ne može se procijeniti iz dostupnih podataka).
English: Manufacturer: PfizerIrelandPharmaceuticals, Little Connell,Newbridge, County Kildare, Ireland.
Croatian: Proizvođač: Pfizer Ireland Pharmaceuticals, Little Connell, Newbridge, County Kildare, Irska.
English: What CONBRIZA contains
Croatian: Što CONBRIZA sadrži
English: Bazedoxifene 20 mg
Croatian: Bazedoksifen 20 mg
English: if you have active uterine cancer.
Croatian: ako imate aktivan rak maternice.
English: Therefore, bazedoxifene is not recommended for treatment or prevention of breast cancer.
Croatian: Stoga se bazedoksifen ne preporučuje za liječenje ili prevenciju raka dojke.
English: There is no evidence of endometrial proliferation.
Croatian: Nema znakova proliferacije endometrija.
English: Any uterine bleeding during CONBRIZA therapy is unexpected and should be fully investigated.
Croatian: Svako maternično krvarenje tijekom terapije lijekom CONBRIZA je neočekivano i treba ga u cijelosti istražiti.
English: The absolute bioavailability of bazedoxifene is approximately 6%.
Croatian: Apsolutna bioraspoloživost bazedoksifena iznosi približno 6%.
English: It works by slowing or stopping the thinning of bone in these women.
Croatian: Djeluje tako da u tih žena usporava ili zaustavlja stanjivanje kostiju.
English: If ocular symptoms occur, patients should be advised to seek medical attention.
Croatian: Nastupe li očni simptomi, bolesnicu treba savjetovati da potraži liječničku pomoć.
English: Do not take this medicine if you are breast-feeding, because it is not known whether it is excreted in mother's milk.
Croatian: Ne smijete uzimati ovaj lijek ako dojite jer nije poznato izlučuje li se on u majčino mlijeko.
English: Serious side effects - Stop taking CONBRIZA and see a doctor immediately
Croatian: Ozbiljne nuspojave - prestanite uzimati lijek CONBRIZA i odmah se javite liječniku.
English: What CONBRIZA looks like and contents of the pack
Croatian: Kako CONBRIZA izgleda i sadržaj pakiranja
English: d p-value=0.035
Croatian: d p-vrijednost = 0,035
English: If you feel drowsy after taking this medicine, you should avoid driving or operating machines.
Croatian: Ako nakon uzimanja ovog lijeka osjetite pospanost, morate izbjegavati vožnju i rukovanje strojevima.
English: 7 film-coated tablets 28 film-coated tablets 30 film-coated tablets 84 film-coated tablets 90 film-coated tablets
Croatian: 7 filmom obloženih tableta 28 filmom obloženih tableta 30 filmom obloženih tableta 84 filmom obložene tablete 90 filmom obloženih tableta
English: What CONBRIZA is and what it is used for What you need to know before you take CONBRIZA How to take CONBRIZA
Croatian: Što je CONBRIZA i za što se koristi Što morate znati prije nego počnete uzimati lijek CONBRIZA
English: Pharmacotherapeutic group: Selective estrogen receptor modulator, ATC code: G03XC02.
Croatian: Farmakoterapijska skupina: selektivni modulatori estrogenskih receptora, ATK oznaka: G03XC02.
English: Uncommon Frequency not known (cannot be estimated from available data)
Croatian: Manje često Učestalost nepoznata (ne može se procijeniti iz dostupnih podataka)
English: If you take more CONBRIZA than you should
Croatian: Ako uzmete više lijeka CONBRIZA nego što ste trebali
English: Do not store above 25ºC.
Croatian: Ne čuvati na temperaturi iznad 25°C.
English: If you get any of the problems listed under ‘Do not take CONBRIZA'
Croatian: Ako se pojavi bilo koja tegoba navedena u dijelu "Nemojte uzimati lijek CONBRIZA".
English: If such symptoms occur, patients should avoid driving or use of machines that requires accurate visual perception until symptoms have resolved, or until they have received medical advice that it is safe to do so.
Croatian: Pojave li se takvi simptomi, bolesnice trebaju izbjegavati vožnju ili rukovanje strojevima, koji zahtijevaju preciznu vizualnu percepciju, dok se simptomi ne povuku, odnosno dok im liječnik ne savjetuje da je to sigurno činiti.