FrancophonIA/ELRC3.0 huggingface dataset:
English: 2 x 25 vials (emulsion)
Croatian: 50 bočica (suspenzija) 2 x 25 bočica (emulzija)
English: Adjupanrix
Croatian: emulzija (adjuvans): bočica (staklo)
English: Strength Pharmaceutical form Route of administration
Croatian: (Zaštićeno) ime Doza Farmaceutski oblik
English: An extra drop should be given 30 to 120 minutes before the operation begins.
Croatian: Potrebno je dati jednu dodatnu kapljicu 30 do 120 minuta prije početka operacije.
English: These were measured two weeks after surgery.
Croatian: To je izmjereno dva tjedna nakon operacije.
English: Treatment should begin one day before the cataract operation.
Croatian: Liječenje treba započeti jedan dan prije operacije katarakte.
English: Nevanac nepafenac
Croatian: Nevanac nepafenak
English: The full EPAR for Nevanac 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 Nevanac nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: If other eye medicines are also being used, there should be a gap of at least five minutes between using each medicine.
Croatian: Ukoliko se koriste i drugi lijekovi za oči, između primjene dvaju lijekova treba biti razmak od najmanje pet minuta.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nevanac on 11 December 2007.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Nevanac u promet koje vrijedi na prostoru Europske unije od 11. prosinca 2007.
English: What measures are being taken to ensure the safe and effective use of Nevanac?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Nevanac?
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 Nevanac.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Nevanac.
English: Additionally, contact lens wear is not recommended during the postoperative period following cataract surgery.
Croatian: Osim toga, ne preporučuje se nošenje kontaktnih leća tijekom postoperativnog razdoblja nakon operacije katarakte.
English: Treatment is continued after the operation for 2 to 3 weeks when used to prevent pain and inflammation, or up to 60 days when used to reduce the risk of macular oedema.
Croatian: Liječenje se nastavlja dva do tri tjedna nakon operacije kod primjene za sprečavanje boli i upale, ili do 60 dana kod primjene za smanjivanje rizika od makularnog edema.
English: Why has Nevanac been approved?
Croatian: Zašto je lijek Nevanac odobren?
English: Other information about Nevanac
Croatian: Ostale informacije o lijeku Nevanac
English: The main measure of effectiveness was the number of patients who developed macular oedema within 90 days of surgery.
Croatian: Glavna mjera djelotvornosti bio je broj bolesnika kod kojih se unutar 90 dana od operacije razvio makularni edem.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nevanac have also 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 radi sigurne i učinkovite primjene lijeka Nevanac nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: By reducing the production of prostaglandins in the eye, Nevanac can reduce complications caused by eye surgery, such as inflammation, pain and swelling.
Croatian: Smanjujući proizvodnju prostaglandina u oku, lijek Nevanac može smanjiti komplikacije uzrokovane operacijom oka kao što su upala, bol i oticanje.
English: The CHMP decided that Nevanac's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Nevanac nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje u promet.
English: What is the risk associated with Nevanac?
Croatian: Koji su rizici povezani s lijekom Nevanac?
English: Nevanac is an eye drop suspension that contains the active substance nepafenac (1 and 3 mg/ml).
Croatian: Lijek Nevanac je suspenzija kapi za oči koja sadrži djelatnu tvar nepafenak (1 i 3 mg/ml).
English: For more information about treatment with Nevanac, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Nevanac pročitajte u uputi o lijeku (također dio EPAR-a) odnosno obratite se svom liječniku ili ljekarniku.
English: Nevanac must not be used in people who are hypersensitive (allergic) to nepafenac, to any of the other ingredients or to other NSAIDs.
Croatian: Lijek Nevanac ne smije se primjenjivati u osoba koje su preosjetljive (alergične) na nepafenak, na bilo koji drugi sastojak ovog lijeka ili na druge NSAID-ove.
English: The most common side effects with Nevanac (seen in up to 1 in 100 patients) are inflammation of the surface of the eye, defects in the cornea, the sensation of a foreign body in the eye, and crust forming at edge on the eyelids.
Croatian: Najčešće su nuspojave lijeka Nevanac (mogu se javiti u do 1 na 100 bolesnika) upala površine oka, defekti rožnice, osjećaj stranog tijela u očima, stvaranje krusti na rubu vjeđe.
English: It works by blocking an enzyme called cyclo-oxygenase, which produces prostaglandins, substances that are involved in the inflammation process.
Croatian: Djeluje inhibirajući na enzim naziva ciklooksigenaza, koji proizvodi prostaglandine, tvari uključene u upalni proces.
English: What is Nevanac?
Croatian: Što je Nevanac?
English: The company also carried out studies to show that Nevanac 3 mg/ml given once a day was more effective than placebo and had the same effect in preventing and treating pain and inflammation as Nevanac 1 mg/ml given three times a day.
Croatian: Tvrtka je također provela ispitivanja kako bi dokazala da je primjena lijeka Nevanac jačine 3 mg/ml jednom dnevno djelotvornija od placeba te da ima isti učinak u sprečavanju i liječenju boli i upale kao i lijek Nevanac jačine 1 mg/ml koji se daje tri puta dnevno.
English: Like other NSAIDs, Nevanac must not be used in patients who have previously had an attack of asthma, hives or inflammation of the nasal passages when they take aspirin or other NSAIDs.
Croatian: Kao i kod drugih NSAID-ova, Nevanac se ne smije primjenjivati u bolesnika koji su imali napad astme, urtikariju ili upalu nosne šupljine nakon uzimanja aspirina ili drugog NSAID-a.
English: Therefore, patients should be advised not to wear contact lenses during treatment with Nevanac.
Croatian: Bolesnike je stoga potrebno savjetovati da tijekom liječenja lijekom Nevanac ne nose kontaktne leće.
English: In the second and third study, 2.3% and 5.9% of patients taking Nevanac 3 mg/ml developed macular oedema, respectively, compared with between 17.3% and 14.3% of patients taking placebo.
Croatian: U drugom i trećem ispitivanju, 2,3 % odnosno 5,9 % bolesnika koji su uzimali lijek Nevanac jačine 3 mg/ml razvili su makularni edem, u usporedbi sa 17,3 % i 14,3 % bolesnika koji su uzimali placebo.
English: Nevanac is also used to reduce the risk of macular oedema (swelling in the macula, the central part of the retina at the back of the eye) that can occur after cataract surgery in adult diabetes patients.
Croatian: Lijek Nevanac također se primjenjuje za smanjenje rizika od makularnog edema (oticanje makule, središnjeg dijela mrežnice u stražnjem dijelu oka), koji se može pojaviti nakon operacije katarakte u odraslih bolesnika koji imaju šećernu bolest.
English: The active substance in Nevanac, nepafenac, is a ‘prodrug' of amfenac.
Croatian: Djelatna tvar u lijeku Nevanac, nepafenak, jest „predlijek” amfenaka.
English: In the first study, 3.2% of patients taking Nevanac 1 mg/ml developed macular oedema (4 out of 125), compared with 16.7% of patients taking placebo (21 out of 126).
Croatian: U prvom je ispitivanju 3,2 % bolesnika koji su uzimali lijek Nevanac jačine 1 mg/ml razvilo makularni edem (4 od 125), u usporedbi sa 16,7 % bolesnika koji su uzimali placebo (21 od 126).
English: When Nevanac was compared with placebo, around 70% of the patients using Nevanac had no signs of inflammation after two weeks, compared with 17% to 59% of those using placebo.
Croatian: Prilikom usporedbe lijeka Nevanac s placebom, otprilike 70 % bolesnika koji su uzimali lijek Nevanac nisu imali znakova upale nakon dva tjedna, u usporedbi sa 17 % do 59 % bolesnika koji su primali placebo.
English: This is a summary of the European public assessment report (EPAR) for Nevanac.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Nevanac.
English: Nevanac was more effective than placebo and as effective as ketorolac in reducing signs of inflammation.
Croatian: Lijek Nevanac bio je djelotvorniji od placeba te jednako djelotvoran kao ketorolak u ublažavanju znakova upale.
English: Nevanac contains benzalkonium chloride, which is known to discolour soft contact lenses.
Croatian: Lijek Nevanac sadrži benzalkonij klorid, za koji se zna da može promijeniti boju mekih kontaktnih leća.
English: For reducing the risk of macular oedema, Nevanac has been compared with placebo in three main studies involving 1483 diabetes patients with retinopathy (damage to the retina) undergoing cataract surgery.
Croatian: U pogledu smanjenja rizika od makularnog edema, lijek Nevanac uspoređen je s placebom u tri glavna ispitivanja koja su uključivala 1483 bolesnika s dijabetesom i retinopatijom (oštećenjem mrežnice) koji su podvrgnuti operaciji katarakte.
English: In the study comparing Nevanac with ketorolac, around 65% of both groups of patients showed no or few signs of inflammation.
Croatian: U ispitivanju u kojem je lijek Nevanac uspoređen s lijekom ketorolak, u otprilike 65 % bolesnika u obje skupine nije bilo znakova upale oka ili ih je bilo malo.
English: What benefit has Nevanac shown during the studies?
Croatian: Koje su koristi lijeka Nevanac dokazane u ispitivanjima?
English: One drop of Nevanac is given into the affected eye(s), either three times a day with the 1 mg/ml strength, or once a day if using the 3 mg/ml strength.
Croatian: Jedna kapljica lijeka Nevanac daje se u zahvaćeno oko/oči, tri puta dnevno kod jačine od 1 mg/ml, ili jednom dnevno kod jačine od 3 mg/ml.
English: In diabetes patients, Nevanac was more effective than placebo in reducing the risk of macular oedema.
Croatian: U bolesnika koji boluju od šećerne bolesti lijek Nevanac bio je djelotvorniji od placeba u smanjivanju rizika od makularnog edema.
English: For the prevention and treatment of pain and inflammation, Nevanac 1 mg/ml has been studied in four main studies involving a total of 1,201 patients undergoing cataract surgery.
Croatian: Sprečavanje i liječenje boli i upale lijekom Nevanac jačine 1 mg/ml ispitivano je u okviru četiriju glavnih ispitivanja na ukupno 1201 bolesniku koji su bili podvrgnuti operaciji katarakte.
English: One study compared Nevanac 1 mg/ml used once, twice or three times a day with placebo (dummy eye drops) in 220 patients.
Croatian: U jednom je ispitivanju primjena lijeka Nevanac jačine 1 mg/ml jednom, dvaput ili tri puta dnevno uspoređena s placebom (slijepo liječenje kapljicama za oči) u 220 bolesnika.
English: What is Nevanac used for?
Croatian: Za što se Nevanac koristi?
English: This means that it is converted into amfenac in the eye. Amfenac is a non-steroidal anti-inflammatory drug (NSAID).
Croatian: Amfenak je nesteroidni protuupalni lijek (NSAID).
English: In the study comparing different numbers of drops daily, the patients using Nevanac 1 mg/ml three times a day had the lowest failure rate.
Croatian: U ispitivanju u kojem je uspoređena primjena različitog broja kapljica dnevno, stopa neuspješnosti bila je najniža u bolesnika koji su tri puta dnevno uzimali lijek Nevanac jačine 1 mg/ml.
English: Another three studies, in a total of 981 patients, compared Nevanac used three times a day, either with placebo, with ketorolac eye drops (another NSAID) or with both placebo and ketorolac.
Croatian: Nevanac tri puta dnevno uspoređena je u još tri ispitivanja na ukupno 981 bolesniku s placebom, s ketorolak kapljicama za oči (još jedan nesteroidni protuupalni lijek), ili s primjenom placeba i lijeka ketorolak zajedno.
English: Nevanac is used in adults to prevent and treat the pain and inflammation that can occur after an operation to remove a cataract from the eye.
Croatian: Lijek Nevanac primjenjuje se u odraslih osoba za sprečavanje i liječenje boli i upale koja se može pojaviti nakon operacije katarakte.
English: The first main study used Nevanac 1 mg/ml whereas the other 2 main studies used Nevanac 3 mg/ml.
Croatian: U prvom glavnom ispitivanju koristio se lijek Nevanac jačine 1 mg/ml, a u druga dva ispitivanja lijek Nevanac jačine 3 mg/ml.
English: How is Nevanac used?
Croatian: Kako se Nevanac koristi?
English: How does Nevanac work?
Croatian: Kako djeluje Nevanac?
English: For the full list of all side effects reported with Nevanac, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Nevanac potražite u uputi o lijeku.
English: How has Nevanac been studied?
Croatian: Kako je lijek Nevanac ispitivan?
English: The usual dose is one tablet taken once a day with food.
Croatian: Preporučena je doza jedna tableta jednom dnevno uz obrok.
English: The full EPAR for Tenofovir disoproxil Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Tenofovir disoproxil Mylan nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Tenofovir is a nucleotide reverse-transcriptase inhibitor (NRTI).
Croatian: Tenofovir je nukleotidni inhibitor reverzne transkriptaze (NRTI).
English: It is used in patients with liver damage but whose liver is still working properly (compensated liver disease).
Croatian: Primjenjuje se u bolesnika s oštećenjem jetre, ali čija jetra još uvijek normalno funkcionira (kompenzirana bolest jetre).
English: In adolescents (from 12 to 18 years of age) its use is only for those who cannot be treated with other first-line nucleotide reverse transcriptase inhibitors (NRTI).
Croatian: U adolescenata (od 12 do 18 godina) primjenjuje se samo u onih bolesnika koje se ne može liječiti drugim nukleotidnim inhibitorima reverzne transkriptaze (NRTI) prve linije liječenja.
English: Tenofovir also interferes with the action of an enzyme produced by the hepatitis-B virus called ‘DNA polymerase', which is involved in the formation of viral DNA.
Croatian: Tenofovir također ometa djelovanje enzima kojeg stvara virus hepatitisa B, naziva „DNK polimeraza”, koji sudjeluje u stvaranju virusnog DNK-a.
English: This means that it is similar to a ‘reference medicine' already authorised in the European Union (EU)
Croatian: To znači da je sličan „referentnom lijeku” koji je već odobren u Europskoj uniji pod nazivom Viread.
English: The company that makes Tenofovir disoproxil Mylan will also ensure that all doctors who are expected to prescribe or use the medicine are provided with educational materials containing important safety information, particularly on the risks and precautions relating to kidney function and the bones.
Croatian: Tvrtka koja stavlja na tržište lijek Tenofovir disoproxil Mylan osigurat će da svi liječnici od kojih se očekuje da će propisivati ili primjenjivati lijek prime edukativne materijale s važnim informacijama o sigurnosti, osobito o rizicima i mjerama opreza u pogledu funkcije rada bubrega i kostiju.
English: In HIV infection, it blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to reproduce itself in the cells it has infected.
Croatian: U slučaju infekcije HIV-om, on onemogućuje djelovanje reverzne transkriptaze, enzima kojeg stvara HIV, a koji virusu omogućuje množenje u stanicama koje je zarazio.
English: In adults, it can also be used for those patients with liver damage whose liver is not working properly (decompensated liver disease) and those patients who do not respond to treatment with lamivudine (another medicine for hepatitis B).
Croatian: U odraslih se osoba može upotrebljavati i u bolesnika s oštećenjem jetre čija jetra ne funkcionira normalno (dekompenzirana bolest jetre) te u bolesnika koji ne odgovaraju na liječenje lamivudinom (drugim lijekom za liječenje hepatitisa B).
English: Tenofovir disoproxil Mylan, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Croatian: Lijek Tenofovir disoproxil Mylan, kada se uzima u kombinaciji s drugim antivirusnim lijekovima, smanjuje količinu HIV-a u krvi i održava je na niskoj razini.
English: Tenofovir disoproxil Mylan is also used to treat chronic (long-term) hepatitis B virus infection in adults and adolescents from 12 years of age.
Croatian: Tenofovir disoproxil Mylan koristi se i za liječenje kronične (dugotrajne) infekcije virusom hepatitisa B u odraslih osoba i adolescenata od 12 godina i starijih.
English: The Committee recommended that Tenofovir disoproxil Mylan be approved for use in the EU.
Croatian: Odbor je preporučio odobrenje lijeka Tenofovir disoproxil Mylan za korištenje u EU-u.
English: This is a summary of the European public assessment report (EPAR) for Tenofovir disoproxil Mylan.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Tenofovir disoproxil Mylan.
English: Tenofovir disoproxil Mylan does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Croatian: Lijekom Tenofovir disoproxil Mylan ne liječi se infekcija HIV-om ni AIDS, ali njegovom se primjenom može odgoditi narušavanje imunosnog sustava i izbjeći razvoj infekcija i bolesti povezanih s AIDS-om.
English: For patients who have taken medicines to treat HIV infection before, doctors should only prescribe Tenofovir disoproxil Mylan once they have looked at the antiviral medicines the patient has taken before or the likelihood of the virus's response to antiviral medicines.
Croatian: Bolesnicima koji su prethodno uzimali lijekove za liječenje HIV-a liječnici smiju propisivati lijek Tenofovir disoproxil Mylan isključivo nakon što provjere koje je antivirusne lijekove bolesnik prethodno uzimao ili nakon što provjere vjerojatnost odgovora virusa na antivirusne lijekove.
English: Tenofovir disoproxil Mylan stops the virus making DNA and prevents it from multiplying and spreading.
Croatian: Lijek Tenofovir disoproxil Mylan onemogućuje da virus stvara DNK i tako sprečava njegovo umnožavanje i širenje.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tenofovir disoproxil Mylan have also 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 Tenofovir disoproxil Mylan nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Tenofovir disoproxil Mylan is used to treat adults and adolescents from 12 years of age infected with human immunodeficiency virus type 1 (HIV 1), a virus that causes acquired immune deficiency syndrome (AIDS).
Croatian: Tenofovir disoproxil Mylan primjenjuje se za liječenje odraslih osoba i adolescenata u dobi od 12 godina i starijih, zaraženih virusom humane imunodeficijencije tipa 1 (HIV1), virusom koji uzrokuje sindrom stečene imunodeficijencije (AIDS).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Tenofovir disoproxil Mylan has been shown to have comparable quality and to be bioequivalent to Viread.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je, u skladu sa zahtjevima EU-a, potvrđeno da Tenofovir disoproxil Mylan posjeduje usporedivu kakvoću te je bioekvivalentan s lijekom Viread.
English: What measures are being taken to ensure the safe and effective use of Tenofovir disoproxil Mylan?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Tenofovir disoproxil Mylan?
English: Because Tenofovir disoproxil Mylan is a generic medicine 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 lijek Tenofovir disoproxil Mylan generički lijek te da je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: Tenofovir disoproxil Mylan is used in combination with other HIV medicines.
Croatian: Lijek Tenofovir disoproxil Mylan primjenjuje se u kombinaciji s drugim lijekovima za liječenje HIV-a.
English: For more information about treatment with Tenofovir disoproxil Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Tenofovir disoproxil Mylan pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Tenofovir disoproxil Mylan tenofovir disoproxil
Croatian: Tenofovir disoproxil Mylan tenofovirdizoproksil
English: The active substance in this medicine, tenofovir disoproxil, is a ‘prodrug' that is converted into tenofovir in the body.
Croatian: Djelatna tvar u lijeku Tenofovir disoproxil Mylan, tenofovirdizoproksil, je „prolijek” koji se u tijelu pretvara u tenofovir.
English: It is not intended to provide practical advice on how to use Tenofovir disoproxil Mylan.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Tenofovir disoproxil Mylan.
English: Other information about Tenofovir disoproxil Mylan
Croatian: Ostale informacije o lijeku Tenofovir disoproxil Mylan
English: Because Tenofovir disoproxil Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Viread.
Croatian: Budući da je lijek Tenofovir disoproxil Mylan generički lijek, ispitivanja na ljudima bila su ograničena na ispitivanja za utvrđivanje bioekvivalencije s referentnim lijekom Viread.
English: What is Tenofovir disoproxil Mylan and what is it used for?
Croatian: Što je Tenofovir disoproxil Mylan i za što se koristi?
English: What are the benefits and risks of Tenofovir disoproxil Mylan?
Croatian: Koje su koristi i rizici lijeka Tenofovir disoproxil Mylan?
English: The dose may need to be reduced or the medicine given less often in patients who have moderately or severely reduced kidney function.
Croatian: Bolesnicima s umjerenim ili teškim oštećenjem funkcije bubrega dozu je možda potrebno smanjiti ili lijek rjeđe davati.
English: For practical information about using Tenofovir disoproxil Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Tenofovir disoproxil Mylan pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: Why is Tenofovir disoproxil Mylan approved?
Croatian: Zašto je lijek Tenofovir disoproxil Mylan odobren?
English: Tenofovir disoproxil Mylan contains the active substance tenofovir disoproxil.
Croatian: Lijek Tenofovir disoproxil Mylan sadrži djelatnu tvar tenofovirdizoproksil.