FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment with Cystadrops also led to reductions in photophobia (eye discomfort in bright light).
Croatian: Liječenje lijekom Cystadrops također je dovelo do smanjenja fotofobije (osjećaja nelagode u oku izazvanog jarkim svjetlom).
English: The main measure of effectiveness was based on the reduction in corneal cystine crystals as seen under the microscope and quantified using a score called the IVCM score.
Croatian: Procjena glavne mjere djelotvornosti temeljila se na smanjenju cistinskih kristala u rožnici promatranih pod mikroskopom i kvantificiranih s pomoću tzv. IVCM rezultata.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cystadrops 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 Cystadrops nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Cystadrops can only be obtained with a prescription and treatment should be started under the supervision of a doctor experienced in the management of cystinosis.
Croatian: Lijek Cystadrops izdaje se samo na liječnički recept, a liječenje se treba započeti pod nadzorom liječnika iskusnog u liječenju cistinoze.
English: Mercaptamine eye drop solutions made up locally in pharmacies or hospitals have been used for many years for the management of eye symptoms of cystinosis.
Croatian: Otopine kapi za oko koje sadrže merkaptamin i koje su izrađene u lokalnim ljekarnama ili bolnicama primjenjuju se već niz godina za rješavanje očnih simptoma cistinoze.
English: Cystinosis is an inherited disease where a natural substance called cystine builds up in the body forming damaging crystals, particularly in the kidneys and cornea (the transparent layer in front of the eye).
Croatian: Cistinoza je nasljedna bolest kod koje se prirodna tvar cistin nakuplja u tijelu i stvara kristale štetnog djelovanja, osobito u bubrezima i rožnici (prozirnom sloju u prednjem dijelu oka).
English: The active substance in Cystadrops, mercaptamine, reacts with cystine to dissolve it and to form substances that can be removed from the cells.
Croatian: Djelatna tvar u lijeku Cystadrops, merkaptamin, reagira s cistinom tako što ga otapa i stvara tvari koje se mogu ukloniti iz stanica.
English: Why is Cystadrops approved?
Croatian: Zašto je lijek Cystadrops odobren?
English: It is not intended to provide practical advice on how to use Cystadrops.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Cystadrops.
English: What are the risks associated with Cystadrops?
Croatian: Koji su rizici povezani s lijekom Cystadrops?
English: Damage from the build-up of cystine crystals inside the cells of the cornea can cause serious vision problems.
Croatian: Nakupljanje cistinskih kristala može stvoriti oštećenja u stanicama rožnice, što može izazvati ozbiljne probleme s vidom.
English: For practical information about using Cystadrops, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Cystadrops bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: Cystadrops has been compared with another less concentrated mercaptamine eye drop solution in one main study involving 32 patients from 2 years of age with cystinosis.
Croatian: Lijek Cystadrops uspoređen je s drugom otopinom kapi za oko slabije koncentracije koja sadrži merkaptamin u jednom glavnom ispitivanju na 32 bolesnika od dvije godine starosti i starijih, koji boluju od cistinoze.
English: When it is applied to the eye, the amount of cystine in the cells of the cornea decreases, limiting damage to the eye.
Croatian: Pri primjeni lijeka u oko količina cistina u stanicama rožnice smanjuje se, čime se smanjuje stupanj oštećenja oka.
English: Cystadrops is available as eye drops.
Croatian: Lijek Cystadrops dostupan je u obliku kapi za oko.
English: Cystadrops is an eye medicine used in patients from 2 years of age who have cystinosis.
Croatian: Cystadrops je lijek za oko koji se primjenjuje u djece u dobi od dvije godine i starijih bolesnika koji boluju od cistinoze.
English: For more information about treatment with Cystadrops, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Cystadrops pročitajte u uputi o lijeku (također dio EPAR-a) odnosno obratite se svom liječniku ili ljekarniku.
English: Cystadrops was shown to be more effective than the comparator at decreasing corneal cystine crystals after 3 months of treatment: in patients using Cystadrops the IVCM score decreased by 4.6 points compared with a decrease of 0.5 points in patients using the comparator.
Croatian: U bolesnika koji su uzimali Cystadrops IVCM rezultat smanjen je za 4,6 boda u usporedbi sa smanjenjem od 0.5 bodova u bolesnika koji su uzimali usporedni lijek.
English: Cystadrops is used to reduce the build-up of cystine crystals in the cornea.
Croatian: Lijek Cystadrops primjenjuje se kako bi se smanjilo nakupljanje cistinskih kristala u rožnici.
English: How does Cystadrops work?
Croatian: Kako djeluje Cystadrops?
English: How is Cystadrops used?
Croatian: Kako se Cystadrops koristi?
English: In addition, Cystadrops has been shown in a study to be effective at decreasing corneal cystine crystals.
Croatian: Osim toga, lijek Cystadrops u ispitivanju se pokazao djelotvornim u smanjenju broja cistinskih kristala u rožnici.
English: What benefits of Cystadrops have been shown in studies?
Croatian: Koje su koristi lijeka Cystadrops utvrđene u ispitivanjima?
English: For the full list of all side effects and restrictions with Cystadrops, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Cystadrops potražite u uputi o lijeku.
English: It is available as tablets (50 and 150 mg).
Croatian: Dostupan je u tabletama (50 i 150 mg).
English: Ibandronic Acid Teva EMA/357446/2015
Croatian: Ibandronatna kiselina Teva EMA/357446/2015
English: The tablets must always be taken after the patient has fasted overnight for at least six hours and at least 30 minutes before the first food or drink of the day.
Croatian: Tablete se uvijek trebaju uzimati na prazan želudac, nakon što je bolesnik postio preko noći najmanje šest sati, a najmanje 30 minuta prije prvog obroka ili pića tog dana.
English: Ibandronic Acid Teva must be taken with a full glass of plain water (but not mineral water) while standing or sitting up, and the tablets should not be chewed, sucked or crushed.
Croatian: Ibandronatnu kiselinu Teva treba uzeti s punom čašom obične vode (ali ne mineralne vode) stojeći ili sjedeći, a tablete se ne smiju žvakati, cuclati niti drobiti.
English: The tablet must always be taken after an overnight fast, one hour before any food or drink except for water.
Croatian: Tableta se uvijek treba uzimati nakon noćnog posta, jedan sat prije bilo kakvog unosa hrane ili tekućine osim vode.
English: For treating osteoporosis, one 150-mg tablet is taken once a month.
Croatian: Za terapiju osteoporoze uzima se jedna tableta od 150 mg jednom mjesečno.
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 Ibandronic Acid Teva.
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 i svoje preporuke za uporabu lijeka Ibandronatna kiselina Teva.
English: This means that Ibandronic Acid Teva is similar to a ‘reference medicine' already authorised in the European Union (EU).
Croatian: To znači da je lijek Ibandronatna kiselina Teva sličan „referentnom lijeku” koji je već odobren u Europskoj uniji.
English: The European Commission granted a marketing authorisation valid throughout the EU for Ibandronic Acid Teva on 17 September 2010.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Ibandronatna kiselina Teva na snazi u Europskoj uniji od 17. rujna 2010.
English: It stops the action of osteoclasts, the cells in the body that are involved in breaking down the bone tissue.
Croatian: Blokira aktivnost osteoklasta, stanica u tijelu koje su uključene u razgradnju koštanog tkiva.
English: For the prevention of skeletal events, one 50-mg tablet is taken once a day.
Croatian: Za prevenciju koštanih poremećaja uzima se jedna tableta od 50 mg na dan.
English: The CHMP concluded that, in accordance with EU requirements, Ibandronic Acid Teva has been shown to have comparable quality and to be bioequivalent to Bondronat and Bonviva.
Croatian: CHMP zaključio je kako je, u skladu sa zahtjevima EU-a, potvrđeno kako lijek Ibandronatna kiselina Teva posjeduje usporedivu kvalitetu te je bioekvivalentan lijekovima Bondronat i Bonviva.
English: This is a summary of the European public assessment report (EPAR) for Ibandronic Acid Teva.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Ibandronatna kiselina Teva.
English: Because Ibandronic Acid Teva is a generic medicine and is bioequivalent to the reference medicines, its benefits and risks are taken as being the same as the reference medicines's.
Croatian: Budući da je Ibandronatna kiselina Teva generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: Its effect in reducing the risk of spine fractures has been shown in studies, but its effect on the risk of fractures of the neck of the femur (the top of the thighbone) has not been established.
Croatian: Ispitivanjima je utvrđeno djelovanje lijeka na smanjenje rizika od frakture kralješnice, no nije utvrđeno djelovanje na rizik od frakture vrata femura (gornjeg dijela bedrene kosti).
English: Ibandronic Acid Teva 50 mg is used to prevent ‘skeletal events' (fractures [broken bones] or bone complications requiring treatment) in patients with breast cancer and bone metastases (when the cancer has spread to the bone).
Croatian: Ibandronatna kiselina Teva koristi se za sprječavanje „koštanih poremećaja” (fraktura [prijeloma kostiju] ili koštanih komplikacija koje zahtijevaju liječenje) u bolesnika s rakom dojke i metastazama u kostima (ako se rak proširio u kosti).
English: Ibandronic Acid Teva 150 mg is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of developing bone fractures.
Croatian: Ibandronatna kiselina Teva koristi se za liječenje osteoporoze (bolesti koja kosti čini lomljivima) u žena u postmenopauzi koje su izložene riziku od razvoja fraktura kostiju.
English: Ibandronic Acid Teva is a ‘generic medicine'.
Croatian: Ibandronatna kiselina Teva je „generički lijek”.
English: The full EPAR for Ibandronic Acid Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Ibandronatna kiselina Teva nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports Više informacija o liječenju lijekom Ibandronatna kiselina Teva pročitajte u uputi o lijeku (također dio EPARa) ili se obratite svom liječniku ili ljekarniku.
English: The reduction of bone loss helps to make bones less likely to break, which is useful in preventing fractures in cancer patients with bone metastases and in women with osteoporosis.
Croatian: Smanjeni gubitak koštane mase smanjuje vjerojatnost prijeloma kostiju što je korisno za sprječavanje fraktura u bolesnika s rakom i metastazama u kostima te u žena s osteoporozom.
English: What are the benefits and risks of Ibandronic Acid Teva?
Croatian: Koje su koristi i rizici od lijeka Ibandronatna kiselina Teva?
English: Because Ibandronic Acid Teva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicines.
Croatian: Budući da je Ibandronatna kiselina Teva generički lijek, ispitivanja na bolesnicima bila su ograničena na utvrđivanje činjenice je li riječ o bioekvivalentu referentnom lijeku.
English: The reference medicines for Ibandronic Acid Teva are Bondronat and Bonviva.
Croatian: Referentni lijekovi za lijek Ibandronatna kiselina Teva su Bondronat i Bonviva.
English: The active substance in Ibandronic Acid Teva, ibandronic acid, is a bisphosphonate.
Croatian: Djelatna tvar u lijeku Ibandronatna kiselina Teva, ibandronatna kiselina, je bisfosfonat.
English: The Committee recommended that Ibandronic Acid Teva be given marketing authorisation.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Ibandronatna kiselina Teva.
English: Patients should also take vitamin D and calcium supplements if they do not get enough from their diet.
Croatian: Bolesnici također trebaju uzimati nadomjeske kalcija i vitamina
English: Ibandronic Acid Teva is a medicine that contains the active substance ibandronic acid.
Croatian: Ibandronatna kiselina Teva je lijek koji sadrži ibandronatnu kiselinu kao djelatnu tvar.
English: Other information about Ibandronic Acid Teva:
Croatian: Ostale informacije o lijeku Ibandronatna kiselina Teva
English: Why has Ibandronic Acid Teva been approved?
Croatian: Zašto je lijek Ibandronatna kiselina Teva odobren?
English: Ibandronic Acid Teva ibandronic acid
Croatian: Ibandronatna kiselina Teva ibandronatna kiselina
English: What is Ibandronic Acid Teva?
Croatian: Što je Ibandronatna kiselina Teva?
English: Therefore, the CHMP's view was that, as for Bondronat and Bonviva, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a kako koristi nadmašuju utvrđene rizike, kao i kod lijekova Bondronat i Bonviva.
English: How is Ibandronic Acid Teva used?
Croatian: Kako se Ibandronatna kiselina Teva koristi?
English: How has Ibandronic Acid Teva been studied?
Croatian: Kako je lijek Ibandronatna kiselina Teva ispitivan?
English: What is Ibandronic Acid Teva used for?
Croatian: Za što se Ibandronatna kiselina Teva koristi?
English: How does Ibandronic Acid Teva work?
Croatian: Kako djeluje Ibandronatna kiselina Teva?
English: The reason for this is not known.
Croatian: Razlog tome nije poznat.
English: Take this medicine one or two times a day every day with food.
Croatian: Uzmite ovaj lijek jednom ili dva puta na dan, svaki dan s hranom.
English: After first opening, use within 100 days.
Croatian: Nakon prvog otvaranja iskoristiti u roku od 100 dana.
English: ~3 to 5
Croatian: ~3 do 5
English: • bad taste in the mouth
Croatian: • loš okus u ustima
English: To be taken with food.
Croatian: Uzimati s hranom.
English: If you think you are pregnant or you are planning to become pregnant, it is very important that you discuss this with your doctor.
Croatian: Ako mislite da ste trudni ili planirate zatrudnjeti, vrlo je važno da o tome raspravite sa svojim liječnikom.
English: This medicine has been prescribed for you.
Croatian: - Ovaj je lijek propisan Vama.
English: AUC12 or 24
Croatian: AUC12 ili 24
English: These measures will help the environment.
Croatian: Ove će mjere pomoći u očuvanju okoliša.
English: • damage to the nerves that can cause weakness and pain
Croatian: • oštećenje živaca koje može uzrokovati slabost i bol
English: Your doctor will discuss with you the best combination of medicines for you.
Croatian: Liječnik će s Vama raspraviti o tome koja je kombinacija lijekova za Vas najbolja.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you or your child.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrži Vama ili Vašem djetetu važne podatke.
English: In some patients additional factor VIII was given.
Croatian: Neki su bolesnici dodatno primali faktor VIII.
English: Symptoms of infection - inform your doctor immediately.
Croatian: - Simptomi infekcije - Odmah o tome obavijestite svog liječnika.
English: • allergic reactions including skin rashes
Croatian: • alergijske reakcije, uključujući kožni osip
English: It is believed that this happens because the body's immune response improves and helps the body to fight these infections.
Croatian: Vjeruje se da se to događa zato što se imunološki odgovor tijela oporavlja i pomaže tijelu u borbi protiv tih infekcija.
English: Some people had other illnesses or were taking other medicines.
Croatian: Neki su bolesnici bolovali od drugih bolesti ili su uzimali druge lijekove.
English: Cl/F (L/h) 1 Values expressed as geometric means.
Croatian: Cl/F (L/h) 1 Vrijednosti izražene kao geometrijske sredine.
English: If it is nearly time for the next dose, just take that one.
Croatian: Ako je blizu vrijeme za uzimanje iduće doze, jednostavno uzmite tu iduću dozu.
English: Tell your doctor as soon as possible if this applies to you.
Croatian: Recite to što prije svom liječniku ako se to odnosi na Vas.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Croatian: Za sve informacije o ovom lijeku molimo obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet:
English: Ritonavir Mylan should be taken every day to help control your HIV, no matter how much better you feel.
Croatian: Ritonavir Mylan morate uzimati svaki dan kako bi se kontrolirao HIV, bez obzira na to koliko se bolje osjećate.
English: Digoxin (heart medicine).
Croatian: - Digoksin (lijek za srce).
English: There are some other medicines that can only be used under certain circumstances as described below.
Croatian: Neke druge lijekove smijete uzimati samo pod posebnim uvjetima, kao što je opisano niže.
English: Ritonavir can be used during pregnancy if clinically needed.
Croatian: Ritonavir se može primjenjivati tijekom trudnoće ako je to klinički potrebno.
English: 1 Based on parallel group comparison.
Croatian: 1 Zasnovano na usporedbi paralelnih skupina.
English: Therefore concomitant use is not recommended.
Croatian: Stoga se istodobna primjena ne preporučuje.
English: Other pharmaceutical forms/strengths may be more appropriate for administration to this population.
Croatian: Drugi farmaceutski oblici/jačine mogu biti prikladniji za primjenu u ovoj populaciji.
English: If you have any other health concerns, discuss these with your doctor as soon as you can.
Croatian: - Ako ste na bilo koji način zabrinuti za svoje zdravlje, raspravite o tome sa svojim liječnikom čim budete mogli.
English: Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Croatian: Te se reakcije obično javljaju unutar prvih nekoliko tjedana ili mjeseci nakon uvođenja CART-a.
English: Other forms of this medicine may be more appropriate for children who have difficulty swallowing tablets.
Croatian: Drugi oblici ovog lijeka mogu biti prikladniji za djecu koja imaju poteškoća s gutanjem tableta.
English: Tell your doctor if you experience:
Croatian: Recite svom liječniku ako iskusite:
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness: 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: Unutar svake skupine prema učestalosti, nuspojave su navedene padajućim slijedom prema njihovoj ozbiljnosti: vrlo često (≥ 1/10); često (≥ 1/100 i<1/10); manje često (≥ 1/1000 i<1/100); rijetko (≥ 1/10 000 i<1/1,000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The following studies are the most important.
Croatian: U nastavku su navedeni rezultati najvažnijih ispitivanja.
English: Currently, there are no data specific to this patient population and therefore specific dosage recommendations cannot be made.
Croatian: Za sada nema podataka specifičnih za tu populaciju bolesnika te se ne mogu dati ni specifične preporuke o doziranju.
English: • low blood pressure and feeling faint when getting up
Croatian: • nizak krvni tlak i osjećaj nesvjestice pri uspravljanju
English: Accumulation of other mutations in the protease gene (including at positions 20, 33, 36, 46, 54, 71, and 90) can also contribute to ritonavir resistance.
Croatian: Nakupljanje ostalih mutacija u genu za proteazu (uključujući položaje 20, 33, 36, 46, 54, 71 i 90) također može doprinijeti rezistenciji na ritonavir.
English: Some patients with advanced HIV infection (AIDS) who then start anti-HIV treatment may develop the symptoms of infections they have had in the past even if they didn't know they had had them.
Croatian: Neki bolesnici s uznapredovalom HIV-infekcijom (AIDS), koji potom počnu liječenje HIV-infekcije, mogu razviti simptome infekcija koje su imali u prošlosti, iako ni ne znaju da su ih imali.
English: Response was similar in both dosing regimens and across patient age.
Croatian: Odgovor je bio sličan pri obje sheme doziranja i bez obzira na dob.
English: • serious allergic reaction (anaphylaxis) • high levels of sugar in the blood
Croatian: • ozbiljna alergijska reakcija (anafilaksija) • visoke razine šećera u krvi
English: In some cases your doctor may need to perform certain tests, change the dose or monitor you regularly.
Croatian: U nekim će slučajevima Vaš liječnik možda ocijeniti potrebnim da obavite određene pretrage, da promijeni dozu ili da Vas redovito prati.
English: Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta.
English: Tell your doctor if you have/had:
Croatian: Recite svom liječniku ako ste imali/imate:
English: To avoid transmitting the infection, mothers with HIV must not breast-feed their babies.
Croatian: Da bi se izbjegao prijenos infekcije, majke s HIV-om ne smiju dojiti djecu.
English: S-Warfarin R-Warfarin
Croatian: S-varfarin R-varfarin
English: If you miss a dose, take the missed dose as soon as possible.
Croatian: Ako propustite dozu, uzmite tu propuštenu što prije.
English: Component of a multipack can't be sold separately.
Croatian: Dio multipakiranja, ne smije se prodavati zasebno.
English: Dosage adjustment for midazolam should be considered, especially if more than a single dose of midazolam is administered.
Croatian: Valja razmotriti prilagođavanje doze midazolama, posebno ako se daje više od jedne doze midazolama.
English: Effects on the electrocardiogram
Croatian: Učinci na elektrokardiogram
English: Tell your doctor if you are taking tadalafil for pulmonary arterial hypertension.
Croatian: Recite svom liječniku ako uzimate tadalafil za plućnu arterijsku hipertenziju.
English: Talk to your doctor or pharmacist if you need five or more tablets daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.
Croatian: Obratite se svom liječniku ili ljekarniku ako Vam je potrebno pet ili više tableta dnevno kroz duže vrijeme, osobito ako vam je preporučena prehrana s niskim udjelom soli (natrija).
English: Reduction in the antiretroviral activity of ritonavir is primarily associated with the protease mutations V82A/F/T/S and I84V.
Croatian: Smanjenje antiretrovirusne aktivnosti ritonavira prvenstveno je povezano s mutacijama proteaze V82A/F/T/S i I84V.
English: Sildenafil or tadalafil for impotence (erectile dysfunction).
Croatian: - Sildenafil ili tadalafil za impotenciju (erektilna disfunkcija).
English: PR interval prolongation
Croatian: Produženje PR-intervala
English: The possibility of medicinal product interaction cannot be excluded.
Croatian: Mogućnost interakcija među tim lijekovima ne može se isključiti.
English: If you are affected do not drive or use machinery.
Croatian: Ako Vam se to dogodi nemojte upravljati vozilima i strojevima.