FrancophonIA/ELRC3.0 huggingface dataset:
English: Lucentis is a medicine used to treat adults with certain sight problems caused by damage to the retina (the light-sensing layer at the back of the eye), and more specifically its central region, known as the macula.
Croatian: Lucentis je lijek koji se primjenjuje za liječenje odraslih osoba s određenim problemima s vidom koji su uzrokovani oštećenjem mrežnice (sloj tkiva u stražnjem dijelu oka osjetljiv na svjetlost), točnije njezinog središnjeg dijela, poznatog kao makula.
English: The patients cannot tell whether they received Lucentis or the sham procedure.
Croatian: Bolesnici ne znaju jesu li primili lijek Lucentis ili placebo.
English: The main measure of effectiveness was the change in vision in the affected eye after a year of treatment, using a standard eye test with a letter chart.
Croatian: Glavna mjera učinkovitosti bila je promjena u vidu u zahvaćenom oku nakon godine dana liječenja, upotrebom standardnog testa za oči s tablicom sa slovima.
English: The main measure of effectiveness in both was the change in vision using a standard eye test with a letter chart.
Croatian: Glavna mjera učinkovitosti u oba ispitivanja bila je promjena u vidu upotrebom standardnog testa za oči s tablicom sa slovima.
English: For more information about using Lucentis, see the package leaflet or contact your doctor or pharmacist
Croatian: Više informacija o primjeni lijeka Lucentis pročitajte u uputi o lijeku ili se obratite liječniku ili ljekarniku.
English: Three main studies of Lucentis involved 1,323 patients with the wet form of AMD.
Croatian: U trima glavnim ispitivanjima lijeka Lucentis bilo je obuhvaćeno 1 323 bolesnika s vlažnim oblikom AMD-a.
English: Lucentis was more effective than a sham injection: patients receiving Lucentis at the 0.5 mg dose for six months could see around 11 letters more than patients receiving a sham injection in one study and 14 letters more in the other study.
Croatian: Lucentis je bio djelotvorniji od placebo injekcije: bolesnici koji su primali Lucentis od 0,5 mg tijekom šest mjeseci mogli su vidjeti približno 11 slova više od bolesnika koji su primali placebo injekciju u jednom ispitivanju te 14 slova više u drugom ispitivanju.
English: VEGF-A is a protein that makes blood vessels grow and leak fluid and blood, damaging the macula.
Croatian: VEGF-A je protein koji potiče rast krvnih žila te uzrokuje propuštanje tjelesnih tekućina i krvi, čime se oštećuje makula.
English: It is given by intravitreal injection (injection into the vitreous humour, the jelly-like fluid in the eye).
Croatian: Primjenjuje se intravitrealnim injekcijama (injekcijama u staklasto tijelo, želatinastu tekućinu u oku).
English: The wet form of AMD is caused by choroidal neovascularisation (abnormal growth of blood vessels beneath the retina, which may leak fluid and blood and cause swelling);
Croatian: Vlažni oblik AMD-a uzrokovan je koroidnom neovaskularizacijom (nenormalni rast krvnih žila ispod mrežnice, što može uzrokovati propuštanje tekućine i krvi te oticanje).
English: One study compared Lucentis with verteporfin PDT in 277 patients with choroidal neovascularisation associated with pathologic myopia (a severe type of short sightedness).
Croatian: U jednom je ispitivanju lijek Lucentis uspoređen s PDT verteporfinom u 277 bolesnika s koroidnom neovaskularizacijom povezanom s patološkom miopijom (teškim oblikom kratkovidnosti).
English: Two of the studies compared Lucentis with a sham injection ( a procedure similar to a Lucentis injection, in which the syringe is pressed against the surface of the eye but no actual injection is carried out).
Croatian: U dvama ispitivanjima lijek Lucentis uspoređen je s placebo postupkom (postupak sličan davanju injekcije lijeka Lucentis, u kojem se štrcaljka pritisne uz površinu oka, ali se zapravo ubrizgavanje ne provodi).
English: How does Lucentis work?
Croatian: Kako djeluje Lucentis?
English: Ranibizumab has been designed to attach to and block a substance called vascular endothelial growth factor A (VEGF-A).
Croatian: Ranibizumab je namijenjen vezivanju i blokiranju tvari naziva vaskularni endotelni čimbenik rasta A (VEGF-A).
English: It can only be obtained with a prescription and must be given by a qualified eye doctor who is experienced in giving intravitreal injections.
Croatian: Izdaje se samo na recept i smije ga primjenjivati samo za to osposobljen oftalmolog s iskustvom u davanju intravitrealnih injekcija.
English: By blocking this factor, ranibizumab reduces the growth of the blood vessels and controls the leakage and swelling.
Croatian: Blokiranjem tog čimbenika ranibizumab smanjuje rast krvnih žila te kontrolira istjecanje i oticanje.
English: Lucentis was more effective at preventing a worsening of vision than the comparison treatment.
Croatian: Lijek Lucentis bio je učinkovitiji u sprječavanju pogoršanja vida od ostalih usporednih liječenja.
English: Lucentis is available as a solution for injection in prefilled syringes or vials, for single use.
Croatian: Lijek Lucentis dostupan je kao otopina za injekciju u prethodno napunjenim štrcaljkama ili bočicama za jednokratnu upotrebu.
English: The third study compared Lucentis with verteporfin photodynamic therapy (PDT, another treatment for AMD).
Croatian: U trećem ispitivanju lijek Lucentis uspoređen je s fotodinamičkom terapijom verteporfinom (PDT, drugi oblik liječenja za AMD).
English: For choroidal neovascularisation other than that associated with wet AMD, Lucentis has been studied in 2 main studies each lasting a year.
Croatian: Za koroidnu neovaskularizaciju koja nije povezana s vlažnim oblikom AMD-a, lijek Lucentis ispitivan je u dvama glavnim ispitivanjima, od kojih je svako trajalo godinu dana.
English: Macular oedema due to occlusion of retinal veins
Croatian: Makularni edem uzrokovan okluzijom retinalnih vena
English: Treatment with Lucentis is started with one injection every month, with regular checks of the patient's vision and the appearance of the back of the eye, until maximum vision is achieved and/or there are no signs of disease activity; the monitoring and treatment intervals should then be determined by the treating doctor depending on the patient's condition and response.
Croatian: Liječenje lijekom Lucentis započinje jednom injekcijom mjesečno, uz redovite provjere vida bolesnika i izgleda stražnjeg dijela oka dok se ne postigne maksimalni vid i/ili dok ne nestanu svi znakovi aktivnosti bolesti.
English: For macular oedema due to retinal vein occlusion, Lucentis was looked at in two main studies involving a total of 789 patients, where Lucentis was compared with a sham injection.
Croatian: Lijek Lucentis je, u pogledu makularnog edema nastalog kao posljedica okluzije retinalne vene, proučavan u dvama glavnim ispitivanjima koja su uključivala ukupno 789 bolesnika, u kojima je Lucentis uspoređen s placebo injekcijom.
English: The active substance in Lucentis, ranibizumab, is a small piece of a monoclonal antibody.
Croatian: Djelatna tvar u lijeku Lucentis, ranibizumab, maleni je dio monoklonskog protutijela.
English: Lucentis was more effective at improving vision than its comparison treatments.
Croatian: Lijek Lucentis bio je učinkovitiji u poboljšanju vida od usporednih liječenja.
English: What benefits of Lucentis have been shown in studies?
Croatian: Koje su koristi od lijeka Lucentis utvrđene u ispitivanjima?
English: For diabetic macular oedema, Lucentis was studied in two main studies involving a total of 454 patients.
Croatian: Lijek Lucentis je, u pogledu dijabetičkog makularnog edema, ispitan u dvama glavnim ispitivanjima koja su obuhvatila ukupno 454 bolesnika.
English: A second study involved 178 patients with choroidal neovascularisation associated with other conditions, and compared Lucentis with a sham injection.
Croatian: U drugom je ispitivanju, u kojem je sudjelovalo 178 bolesnika s koroidnom neovaskularizacijom povezanom s drugim bolestima, lijek Lucentis uspoređen s placebo injekcijom.
English: • macular oedema (swelling of the macula) caused by diabetes;
Croatian: • makularnog edema (oticanje makule) koji je uzrokovan dijabetesom.
English: In the second study, patients receiving Lucentis on its own or as an add-on to laser photocoagulation could see after one year an average of 5 letters more than patients receiving laser photocoagulation on its own.
Croatian: U drugom su ispitivanju bolesnici koji su primali Lucentis kao monoterapiju ili kao dodatak laserskoj fotokoagulaciji tijekom godinu dana mogli vidjeti prosječno pet slova više od bolesnika koji su primali lasersku fotokoagulaciju kao monoterapiju.
English: On average over the first 3 months of treatment, patients given Lucentis could see around 8 to 9 letters more than those receiving verteporfin PDT.
Croatian: U prva tri mjeseca liječenja bolesnici kojima je davan lijek Lucentis u prosjeku su mogli vidjeti približno osam do devet slova više od onih koji su primali PDT verteporfin.
English: • macular oedema caused by occlusion (blockage) of the veins behind the retina.
Croatian: • makularnog edema uzrokovanog okluzijom (začepljenjem) vena iza mrežnice.
English: In the first study, lasting one year, patients receiving Lucentis could see about 6 letters more than those receiving sham injections.
Croatian: U prvom ispitivanju, koje je trajalo godinu dana, bolesnici koji su primali lijek Lucentis mogli su vidjeti oko šest slova više od onih koji su primali placebo injekcije.
English: The first study compared Lucentis with a sham injection.
Croatian: U prvom je ispitivanju lijek Lucentis uspoređen s placebo injekcijom.
English: The second study compared Lucentis, given on its own or as an add-on to laser photocoagulation (a treatment for diabetic macular oedema using a laser), with laser photocoagulation on its own.
Croatian: U drugom ispitivanju uspoređen je lijek Lucentis, koji se davao kao monoterapija ili kao dodatak laserskoj fotokoagulaciji (liječenju dijabetičkog makularnog edema upotrebom lasera) s laserskom fotokoagulacijom kao monoterapijom.
English: Lucentis must not be used in patients who may have an infection of the eye or the area around the eye, or who have severe inflammation within the eye. For the full list of restrictions, see the package leaflet.
Croatian: Lucentis se ne smije davati bolesnicima koji imaju infekciju oka ili područja oko oka ili koji imaju tešku upalu unutar oka.
English: After 2 months of treatment, patients given Lucentis could see around 10 letters more on average than those given sham treatment.
Croatian: Nakon dva mjeseca liječenja bolesnici koji su primali Lucentis mogli su u prosjeku vidjeti oko 10 slova više od onih koji su primili placebo liječenje.
English: How is Lucentis used?
Croatian: Kako se Lucentis primjenjuje?
English: For the full list of all side effects of Lucentis, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Lucentis potražite u uputi o lijeku.
English: EU Number Invented name Strength Pharmaceutical form Route of administration
Croatian: EU odobrenja Zaštićenoime Doza Farmaceutski oblik
English: 100 mg Soluble tablet oral use
Croatian: 100 mg topljiva tableta Kroz usta
English: Sachet one tablet in a multicomponent test kit
Croatian: Vrećica Jedna tableta u višekomponentnim komplet
English: Packaging Content
Croatian: Sastav
English: Pylobactell tablet - 6 glass tubes with caps and bar code labels - 3 additional bar code labels - 30 ml mixing and administration vial.
Croatian: Sigurnosnu naljepnicu i tri dodatne naljepnice s bar kôdovima.
English: glass, with cap - 2 drinking straws - 1 package leaflet - 1 analysis request form - 1 security label for re-sealing
Croatian: Šest staklenih epruveta, s poklopcima i naljepnicama s bar kôdovima.
English: One test kit contains: - 1 sealed sachet containing 1
Croatian: Komplet sadrži: Vrećicu koja sadrži jednu topljivu tabletu Pylobactell 100 mg.
English: Further information on Rheumocam can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Više informacija o VMP-u Rheumocam nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Rheumocam (meloxicam)
Croatian: Rheumocam (meloksikam)
English: Rheumocam received a marketing authorisation valid throughout the EU on 10 January 2008.
Croatian: VMP Rheumocam dobio je odobrenje za stavljanje u promet koje vrijedi na prostoru EU-a od 10. siječnja 2008.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Croatian: Dva su lijeka bioekvivalentna ako proizvode jednake razine djelatne tvari u organizmu.
English: Rheumocam is an anti-inflammatory medicine used in cattle, pigs, horses, dogs and cats.
Croatian: Rheumocam je protuupalni lijek koji se primjenjuje u goveda, svinja, konja, pasa i mačaka.
English: This means that Rheumocam contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Metacam.
Croatian: To znači da Rheumocam sadrži istu djelatnu tvar i djeluje na isti način kao i „referentni VMP” koji je već odobren u Europskoj uniji (EU) pod nazivom Metacam.
English: What is Rheumocam and what is it used for?
Croatian: Što je Rheumocam i za što se primjenjuje?
English: What are the benefits and risks of Rheumocam?
Croatian: Koje su koristi i rizici od VMP-a Rheumocam?
English: Why is Rheumocam authorised in the EU?
Croatian: Zašto je Rheumocam odobren u EU-u?
English: The formulation to use depends on the animal and the condition being treated.
Croatian: Oblik koji će se primijeniti ovisi o životinjskoj vrsti i stanju koje se liječi.
English: Other information about Rheumocam
Croatian: Ostale informacije o VMP-u Rheumocam
English: The withdrawal period for meat is five days for the 20 mg/ml solution for injection and three days for the granules in sachet and 15 mg/ml oral suspension.
Croatian: Razdoblje karencije za meso iznosi pet dana za otopinu za primjenu injekcijom od 20 mg/ml te tri dana za granule u vrećici te peroralnu suspenziju od 15 mg/ml.
English: An overview of Rheumocam and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Rheumocam i zašto je odobren u EU-u
English: It is also the time required after administration of the medicine before milk may be used for human consumption.
Croatian: To je također vrijeme koje treba proći nakon primjene VMP-a prije nego što se mlijeko smije upotrijebiti za prehranu ljudi.
English: Rheumocam contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Croatian: Rheumocam sadržava meloksikam, koji pripada skupini lijekova zvanih nesteroidni protuupalni lijekovi (NSAID).
English: It can be used with oral re-hydration therapy (medicines given by mouth to restore water levels in the body) to reduce diarrhoea in calves of over one week of age and young, non-lactating cattle.
Croatian: Može se primjenjivati u kombinaciji s oralnom rehidracijskom terapijom (lijekovi koji se daju kroz usta kako bi se oporavila razina vode u tijelu) radi smanjenja proljeva u teladi starije od tjedan dana i mladih goveda koja nisu u laktaciji.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Rheumocam has been shown to have comparable quality and to be bioequivalent to Metacam.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, utvrđeno da Rheumocam posjeduje usporedivu kakvoću te da je bioekvivalentan s lijekom Metacam.
English: Therefore the Agency's view was that, as for Metacam, the benefits of Rheumocam, outweigh the identified risks and it can be authorised for use in the EU.
Croatian: Stoga je stav Agencije da, kao i kod VMP-a Metacam, koristi Rheumocama nadmašuju identificirane rizike te da VMP može biti odobren za primjenu u EU-u.
English: Because Rheumocam is a generic and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Rheumocam generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: For further information about using Rheumocam, see the package leaflet or contact your veterinarian or pharmacist.
Croatian: Za dodatne informacije o primjeni VMP-a Rheumocam pogledajte uputu o VMP-u ili se obratite veterinaru ili ljekarniku.
English: Rheumocam can only be obtained with a prescription.
Croatian: Rheumocam se izdaje samo na liječnički recept.
English: In cattle, Rheumocam is used together with appropriate antibiotic therapy, to reduce clinical signs of acute respiratory infection (infection of the lungs and airways).
Croatian: U goveda se lijek Rheumocam primjenjuje zajedno s prikladnom antibiotskom terapijom radi smanjenja znakova akutne respiratorne infekcije (infekcije pluća i dišnih putova).
English: In pigs, Rheumocam is used to reduce lameness and inflammation in non-infectious locomotor disorders (diseases that affect the ability to move), for the relief of post-operative pain after minor soft tissue surgery such as castration, and for supportive therapy together with appropriate antibiotic therapy in the treatment of diseases that occur after farrowing (giving birth) such as puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome).
Croatian: U svinja se lijek Rheumocam primjenjuje u slučaju neinfektivnih poremećaja lokomotornog sustava (bolesti koje utječu na sposobnost kretanja) radi smanjenja simptoma hromosti i upale, za ublažavanje postoperativnih bolova povezanih s manjim kirurškim zahvatima u mekom tkivu poput kastracije te kao potporna terapija uz prikladnu antibiotsku terapiju u liječenju bolesti koje mogu nastupiti nakon prasenja (okota) poput puerperalne septikemije i toksemije (sindrom mastitis-metritis-agalakcija).
English: Rheumocam is available as granules, an oral (taken by mouth) suspension, chewable tablets and a solution for injection.
Croatian: Lijek Rheumocam dostupan je u obliku granula, peroralne suspenzije (primjena kroz usta), tableta za žvakanje i otopine za primjenu injekcijom.
English: In horses, Rheumocam is used to reduce pain associated with colic (abdominal pain) and to lessen inflammation and relieve pain in acute and chronic musculo-skeletal disorders (disorders affecting the muscles and bones).
Croatian: U konja se lijek Rheumocam primjenjuje za ublažavanje bolova povezanih s kolikama (abdominalni bol) te za ublažavanje upale i bolova u akutnih i kroničnih mišićno-koštanih poremećaja (poremećaja koji utječu na mišiće i kosti).
English: Since Rheumocam is a generic medicine, studies have been conducted to determine that it is bioequivalent to the reference medicine, Metacam.
Croatian: Budući da je Rheumocam generički lijek, provedena su ispitivanja kako bi se utvrdila bioekvivalentnost s referentnim lijekom Metacamom.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Rheumocam, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Croatian: U sažetku opisa svojstava, kao i u uputi o VMP-u Rheumocam, nalaze se informacije o sigurnosti primjene, uključujući odgovarajuće mjere opreza kojih se veterinari te vlasnici životinja ili uzgajivači trebaju pridržavati.
English: Moreover, it is used to lessen pain and inflammation in acute and chronic musculo-skeletal disorders.
Croatian: Nadalje, primjenjuje se za olakšavanje boli i upale u akutnih i kroničnih mišićno-koštanih poremećaja.
English: The withdrawal period is the time required after administration of the medicine before an animal can be slaughtered and the meat used for human consumption.
Croatian: Razdoblje karencije je vrijeme koje treba proći nakon primjene VMP-a i prije klanja životinje te primjene mesa za prehranu ljudi.
English: Rheumocam contains the active substance meloxicam and is a generic medicine.
Croatian: Rheumocam sadrži djelatnu tvar meloksikam te je „generički lijek”.
English: It can be used as supportive therapy in the treatment of acute mastitis (inflammation of the udder), in combination with antibiotics.
Croatian: Može se primjenjivati u kombinaciji s antibioticima kao potporna terapija za liječenje akutnog mastitisa (upala vimena).
English: In cats, Rheumocam is used to reduce post-operative pain and inflammation after ovariohysterectomy (spaying operation), orthopaedic and minor soft tissue surgery.
Croatian: U mačaka se Rheumocam primjenjuje za smanjenje postoperativne boli i upale nakon ovariohisterektomije (operacija sterilizacije), ortopedskih i manjih kirurških zahvata na mekom tkivu.
English: How does Rheumocam work?
Croatian: Kako djeluje Rheumocam?
English: In dogs, Rheumocam is used to reduce post-operative pain and inflammation following orthopaedic (e.g. fracture operation) and soft tissue surgery.
Croatian: Rheumocam se u pasa primjenjuje za ublažavanje postoperativne boli i upale nakon ortopedskog zahvata (primjerice operacije frakture) i kirurškog zahvata na mekanom tkivu.
English: How has Rheumocam been studied?
Croatian: Kako je VMP Rheumocam ispitivan?
English: It is available as capsules (5 mg; 20 mg; 100 mg; 140 mg; 180 mg; 250 mg).
Croatian: Dostupan je u kapsulama (5 mg; 20 mg; 100 mg; 140 mg; 180 mg; 250 mg).
English: Temozolomide Accord should be taken without food.
Croatian: Temozolomide Accord treba uzimati bez hrane.
English: This summary was last updated in 05-2015.
Croatian: Ovaj sažetak je posljednji put ažuriran u 05.2015.
English: The full EPAR for Temozolomide Accord can be found can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Temozolomide Accord nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The dose of Temozolomide Accord depends on body surface area (calculated using the patient's height and weight) and ranges from 75 to 200 mg per square metre, once a day.
Croatian: Doza Temozolomide Accord ovisi o tjelesnoj površini bolesnika (izračunava se pomoću visine i tjelesne težine bolesnika) u rasponu od 75 do 200 mg po metru kvadratnom, jednom na dan.
English: The full EPAR for the reference medicine can also be found on the Agency's website.
Croatian: Cjeloviti EPAR za referentni lijek također nalazi se na internetskim stranicama Agencije.
English: The name of the medicine was changed to Temozolomide Accord on 27 May 2015.
Croatian: Naziv lijeka izmijenjen je u Temozolomide Accord 27. svibnja 2015.
English: Patients may also need to take medicines to prevent vomiting before taking Temozolomide Accord.
Croatian: Bolesnici će možda također trebati uzeti lijekove da bi spriječili povraćanje prije uzimanja lijeka Temozolomide Accord.
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 Temozolomide Accord.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist davanja odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima za primjenu lijeka Temozolomide Accord.
English: Temozolomide Accord is used to treat malignant glioma (brain tumours) in the following groups of patients:
Croatian: Temozolomide Accord koristi se za liječenje malignih glioma (tumora mozga) u sljedećim grupama bolesnika:
English: 1 Previously known as Temozolomide Hospira.
Croatian: 1 Ranije poznat pod imenom Temozolomide Hospira
English: • adults and children three years of age and over with malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma, when the tumour has returned or got worse after standard treatment.
Croatian: • u odraslih bolesnika i djece od navršene tri godine starosti s malignim gliomom, kao što je multiformni glioblastom ili anaplastični astrocitom, koji je recidivirao ili napreduje nakon standardne terapije.