FrancophonIA/ELRC3.0 huggingface dataset:
English: For practical information about using Lokelma, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Lokelma bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
English: Why is Lokelma approved?
Croatian: Zašto je lijek Lokelma odobren?
English: In this 4-week study, patients receiving further treatment with Lokelma had lower potassium levels from the second week of treatment than patients taking placebo.
Croatian: U tom 4-tjednom ispitivanju bolesnici koji su nastavili terapiju lijekom Lokelma imali su od drugog tjedna liječenja niže razine kalija nego bolesnici koji su uzimali placebo.
English: How is Lokelma used?
Croatian: Kako se Lokelma koristi?
English: For the full list of all side effects and restrictions with Lokelma, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja zabilježenih pri primjeni lijeka Lokelma potražite u uputi o lijeku.
English: is then eliminated in the stools.
Croatian: putem stolice.
English: What benefits of Lokelma have been shown in studies?
Croatian: Koje su koristi lijeka Lokelma utvrđene u ispitivanjima?
English: It contains the active substance sodium zirconium cyclosilicate.
Croatian: Sadrži djelatnu tvar natrijev cirkonijev ciklosilikat.
English: The active substance in Lokelma, sodium zirconium cyclosilicate, is a potassium binder.
Croatian: Djelatna tvar u lijeku Lokelma, natrijev cirkonijev ciklosilikat, vezuje kalij.
English: How does Lokelma work?
Croatian: Kako djeluje Lokelma?
English: Another main study involved 258 patients who had normal potassium levels after Lokelma treatment.
Croatian: Normalne razine kalija nakon terapije lijekom Lokelma imalo je i 258 bolesnika uključenih u jedno drugo glavno ispitivanje.
English: Treatment should start with a low dose that is gradually increased over the first 14 days of treatment.
Croatian: Liječenje treba započeti s malom dozom koja se postupno povećava tijekom prvih 14 dana terapije.
English: It is available as tablets (100 mg) and should be taken with food.
Croatian: Dostupan je u obliku tableta (100 mg) i treba ga uzimati uz obrok.
English: For younger patients, the recommended dose depends on the patient's height and weight.
Croatian: Za mlađe bolesnike preporučena doza ovisi o visini i tjelesnoj težini bolesnika.
English: The recommended dose for adults (aged 18 years or over) is 600 mg twice a day.
Croatian: Preporučena doza za odrasle osobe (u dobi od 18 ili više godina) iznosi 600 mg dvaput na dan.
English: The full EPAR for Ritonavir 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 Ritonavir Mylan nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The full EPAR for the reference medicine can also be found on the Agency's website.
Croatian: Cjelovito izvješće EPAR za referentni lijek također se nalazi na internetskim stranicama Agencije.
English: The usual dose of Ritonavir Mylan for adults is 100 or 200 mg, once or twice a day.
Croatian: Uobičajena doza lijeka Ritonavir Mylan za odrasle osobe iznosi 100 ili 200 mg jedanput ili dvaput na dan.
English: When the enzyme is blocked, the virus can no longer multiply normally, slowing down its spread.
Croatian: Kada je taj enzim blokiran, virus se ne može normalno umnožavati, što usporava njegovo širenje.
English: Ritonavir Mylan can be used as a ‘pharmacokinetic enhancer' (booster) to increase the blood levels of other antiviral medicines that belong to the same group as Ritonavir Mylan (protease inhibitors) including amprenavir, atazanavir, darunavir, fosamprenavir, lopinavir, saquinavir, and tipranavir.
Croatian: Ritonavir Mylan može se koristiti kao „farmakokinetički pojačivač” radi povećanja krvnih razina drugih protuvirusnih lijekova koji pripadaju istoj skupini kao i Ritonavir Mylan (inhibitori proteaze), uključujući amprenavir, atazanavir, darunavir, fosamprenavir, lopinavir, sakvinavir i tipranavir.
English: This increases the levels of these protease inhibitors in the blood and enhances their antiviral effect.
Croatian: Time se povećavaju razine tih inhibitora proteaze u krvi i jača se njihov protuvirusni učinak.
English: This means that Ritonavir Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Norvir.
Croatian: To znači da Ritonavir Mylan sadržava istu djelatnu tvar i djeluje na isti način kao i „referentni lijek” koji je već odobren u Europskoj uniji (EU) pod nazivom Norvir.
English: As for every medicine, the company provided studies on the quality of Ritonavir Mylan.
Croatian: Kao i za svaki lijek, tvrtka je dostavila ispitivanja o kvaliteti lijeka Ritonavir Mylan.
English: The dose depends on which other protease inhibitor is being taken.
Croatian: Doza ovisi o tome koji se drugi inhibitor proteaze uzima.
English: This is a summary of the European public assessment report (EPAR) for Ritonavir Mylan.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Ritonavir Mylan.
English: Ritonavir Mylan can also be used in larger doses for a direct antiviral effect on HIV.
Croatian: Ritonavir Mylan također se može uzimati u većim dozama radi izravnog protuvirusnog djelovanja na HIV.
English: This means that it blocks a viral enzyme called protease, which is involved in the multiplication of HIV.
Croatian: To znači da djeluje tako da blokira virusni enzim koji se naziva proteaza, a koji je uključen u umnožavanje HIV-a.
English: Ritonavir 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 Ritonavir Mylan ne liječi se infekcija HIV-om ni AIDS, ali se njegovom primjenom može odgoditi narušavanje imunosnog sustava i izbjeći razvoj infekcija i bolesti povezanih s AIDS-om.
English: At higher antiviral doses, ritonavir is a ‘protease inhibitor'.
Croatian: Pri većim protuvirusnim dozama ritonavir je „inhibitor proteaze”.
English: Because Ritonavir 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 Ritonavir Mylan generički lijek te da je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: What measures are being taken to ensure the safe and effective use of Ritonavir Mylan?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ritonavir Mylan?
English: Ritonavir Mylan is used in combination with other medicines to treat patients over two years of age who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Croatian: Ritonavir Mylan koristi se u kombinaciji s drugim lijekovima za liječenje bolesnika starijih od dvije godine zaraženih virusom humane imunodeficijencije tipa 1 (HIV 1), virusom koji prouzročuje sindrom stečene imunodeficijencije (AIDS).
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Norvir, and do not need to be repeated for Ritonavir Mylan.
Croatian: Ispitivanja omjera koristi i rizika djelatne tvari u odobrenim primjenama već su provedena s referentnim lijekom Norvir i ne treba ih ponavljati za lijek Ritonavir Mylan.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Ritonavir Mylan has been shown to have comparable quality and to be bioequivalent to Norvir.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, lijek Ritonavir Mylan dokazao usporedivu kakvoću te da je bioekvivalentan lijeku Norvir.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ritonavir Mylan 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 Ritonavir Mylan nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The Agency recommended that Ritonavir Mylan be approved for use in the EU.
Croatian: Agencija je preporučila davanje odobrenja za stavljanje lijeka Ritonavir Mylan u promet u EU-u.
English: What is Ritonavir Mylan and what is it used for?
Croatian: Što je Ritonavir Mylan i za što se koristi?
English: Other information about Ritonavir Mylan
Croatian: Ostale informacije o lijeku Ritonavir Mylan
English: What are the benefits and risks of Ritonavir Mylan?
Croatian: Koje su koristi i rizici od lijeka Ritonavir Mylan?
English: Therefore, the Agency's view was that, as for Norvir, the benefit outweighs the identified risk.
Croatian: Stoga je mišljenje Agencije da koristi nadmašuju identificirani rizik, kao i za lijek Norvir.
English: It is not intended to provide practical advice on how to use Ritonavir Mylan.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Ritonavir Mylan.
English: For more information about treatment with Ritonavir Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Ritonavir Mylan pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: Ritonavir Mylan contains the active substance ritonavir and is a ‘generic medicine'.
Croatian: Ritonavir Mylan sadržava djelatnu tvar ritonavir te je „generički lijek”.
English: For more information, see the package leaflet provided with the other medicine.
Croatian: Više informacija pročitajte u uputi o lijeku za drugi lijek.
English: Ritonavir Mylan can only be obtained with a prescription and treatment with Ritonavir Mylan should be given by a doctor who has experience in the treatment of HIV infection.
Croatian: Ritonavir Mylan izdaje se samo na liječnički recept, a liječenje lijekom Ritonavir Mylan treba započeti liječnik s iskustvom u liječenju infekcije HIV-om.
English: Ritonavir Mylan, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Croatian: Kada se uzima u kombinaciji s drugim protuvirusnim lijekovima, Ritonavir Mylan smanjuje koncentraciju HIV-a u krvi i održava je na niskoj razini.
English: For practical information about using Ritonavir Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Ritonavir Mylan bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
English: Why is Ritonavir Mylan approved?
Croatian: Zašto je lijek Ritonavir Mylan odobren?
English: As a ‘booster', the active substance ritonavir slows the breakdown of other protease inhibitor antivirals.
Croatian: Djelatna tvar ritonavir djeluje kao „pojačivač” i usporava razgradnju drugih protuvirusnih lijekova koji djeluju kao inhibitori proteaze.
English: How does Ritonavir Mylan work?
Croatian: Kako djeluje Ritonavir Mylan?
English: How is Ritonavir Mylan used?
Croatian: Kako se Ritonavir Mylan koristi?
English: How has Ritonavir Mylan been studied?
Croatian: Kako je Ritonavir Mylan ispitivan?
English: If possible, show them the medicine pack.
Croatian: Ako bude moguće, pokažite im pakiranje lijeka.
English: • hallucinations (seeing or hearing things that are not there).
Croatian: • halucinacije (vidite ili čujete stvari koje ne postoje).
English: Symptoms include:
Croatian: Simptomi uključuju:
English: Date of latest renewal: 14 January 2016
Croatian: Datum posljednje obnove: 14. siječnja 2016.
English: Suicide risk
Croatian: Rizik od samoubojstva
English: At first, these changes might not affect your sight but, over time, it may get worse.
Croatian: U početku te promjene ne moraju utjecati na Vaš vid, ali s vremenom se stanje može pogoršati.
English: The physician's guide should include the following key messages:
Croatian: Vodič liječnicima treba sadržavati sljedeće ključne poruke:
English: Elderly (65 years of age and above)
Croatian: Starije osobe (65 godina i starije)
English: Always take this medicine exactly as your doctor has told you to.
Croatian: Uvijek uzmite ovaj lijek točno onako kako Vam je rekao Vaš liječnik.
English: The duration of the maintenance phase was 8 or 12 weeks.
Croatian: Razdoblje faze održavanja trajalo je 8 ili 12 tjedana.
English: Study (n=population in double-blind phase; n=population in maintenance phase)
Croatian: Ispitivanje (n=populacija u dvostruko-slijepoj fazi; n=populacija u fazi održavanja)
English: Other medicines and Trobalt
Croatian: Drugi lijekovi i Trobalt
English: • difficulty in reading, writing or saying what you mean, or difficulty in understanding words
Croatian: • teškoće pri čitanju, pisanju ili izgovaranju svog mišljenja ili poteškoće u razumijevanju riječi
English: See 'Look out for serious symptoms' in section 4.
Croatian: Pogledajte "Obratite pažnju na ozbiljne simptome" u dijelu 4.
English: Thoughts of harming yourself or suicide
Croatian: Misli o samoozljeđivanju ili samoubojstvu
English: When applicable, a cover letter highlighting the main changes should also be included as part of the educational materials.
Croatian: Kada je primjenjivo, pokrovno pismo, u kojem se naglašavaju glavne promjene, treba biti uključeno kao dio edukacijskih materijala.
English: Trobalt is not recommended for children and adolescents aged under 18.
Croatian: Trobalt se ne preporučuje za djecu i adolescente mlađe od 18 godina.
English: Then leave at least 3 hours before your next dose.
Croatian: Nakon toga pričekajte barem 3 sata prije uzimanja sljedeće doze.
English: Interaction with digoxin
Croatian: Interakcije s digoksinom
English: This is more likely to affect you:
Croatian: To će se vjerojatnije dogoditi ako:
English: The relevance of these models to human epilepsy, however, is not known.
Croatian: Relevantnost ovih modela za epilepsiju u ljudi, međutim, nije poznata.
English: Talk to your doctor before taking Trobalt:
Croatian: Obratite se svom liječniku prije nego uzmete Trobalt:
English: Extremadura 3, 09400 Aranda De Duero, Burgos, Spain.
Croatian: Extremadura 3, 09400 Aranda De Duero, Burgos, Španjolska.
English: You may become aware of blurring of your central vision and notice trouble with reading or recognizing faces.
Croatian: Možete postati svjesni zamućenja Vašeg centralnog vida i primijetiti da imate problema s čitanjem ili prepoznavanjem lica.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.
English: The long-term prognosis of these findings is currently unknown, but some of the reports have been associated with visual impairment.
Croatian: Trenutno nije poznata dugoročna prognoza ovakvih nalaza, ali su neke od prijava bile povezane s oštećenjem vida.
English: • blood in the urine; abnormally coloured urine
Croatian: • krv u urinu; neuobičajena boja urina
English: Look out for serious symptoms
Croatian: Obratite pažnju na ozbiljne simptome
English: Doses greater than 900 mg/day are not recommended (see sections 4.4 and 5.2).
Croatian: Ne preporučuju se doze veće od 900 mg/dan (vidjeti dijelove 4.4 i 5.2).
English: Trobalt may be taken with or without food (see section 5.2).
Croatian: Trobalt se može uzeti s hranom ili bez nje (vidjeti dio 5.2).
English: The effect of food on Cmax under usual clinical conditions is not expected to be clinically relevant.
Croatian: Ne očekuje se da bi učinak hrane na Cmax u uobičajenim kliničkim uvjetima bio klinički značajan.
English: Your doctor should recommend that you have an eye examination before starting treatment.
Croatian: Liječnik bi Vam trebao preporučiti pregled očiju prije započinjanja liječenja.
English: The arrhythmias spontaneously resolved, and both volunteers recovered without sequelae.
Croatian: Aritmije su spontano prošle i oba dobrovoljca oporavila su se bez sekvela.
English: Patients (and caregivers of patients) should be advised to seek medical advice if signs of suicidal ideation or behaviour emerge.
Croatian: Bolesnike (i njegovatelje bolesnika) treba savjetovati da potraže medicinsku pomoć ako se pojave znakovi suicidalnih misli ili ponašanja.
English: Take extra care until you know how Trobalt and alcohol affect you.
Croatian: Budite osobito oprezni dok ne saznate kako Trobalt i alkohol djeluju na Vas.
English: • feeling agitated, aggressive or irritable
Croatian: • osjećaj uzbuđenosti, agresivnosti ili razdraženosti
English: If you need a blood or urine test:
Croatian: Ako trebate obaviti pretrage krvi ili urina:
English: Trobalt is used to treat seizures that affect one part of the brain (partial seizure), which may or may not extend to larger areas on both sides of the brain (secondary generalisation).
Croatian: Trobalt se koristi za liječenje napadaja koji zahvaćaju jedan dio mozga (parcijalni napadaji), koji se mogu ili ne moraju proširiti na veća područja obiju strana mozga (sekundarna generalizacija).
English: Like all medicines, Trobalt can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, Trobalt može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: Interaction with alcohol
Croatian: Interakcija s alkoholom
English: The requirements for submission of periodic safety updates reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i svim sljedećim nadopunama objavljenim na europskom internetskom portalu za lijekove.
English: Don't take more than one dose at a time to make up for missed doses.
Croatian: Nemojte istovremeno uzimati više od jedne doze kako bi nadoknadili propuštene.
English: It is recommended that patients are advised about the risk of these possible effects.
Croatian: Preporučuje se savjetovati bolesnike o mogućem riziku od ovih učinaka.
English: The tablets must be taken in three divided doses each day.
Croatian: Tablete se moraju uzimati svakog dana, podijeljene u tri doze.
English: Currently available pharmacokinetic data are described in section 5.2, but no recommendation on a posology can be made.
Croatian: Trenutno raspoloživi farmakokinetički podaci opisani su u dijelu 5.2, međutim ne mogu se dati preporuke o doziranju.
English: Swallow the tablet whole.
Croatian: Tabletu progutajte cijelu.
English: If continued, the patient should be monitored more closely.
Croatian: Ako se uzimanje lijeka nastavi, bolesnika treba pažljivo pratiti.
English: What Trobalt contains
Croatian: Što Trobalt sadrži
English: The clinical significance of this finding is not known.
Croatian: Nije poznat klinički značaj tog nalaza.
English: Tell the person who orders the test that you are taking Trobalt.
Croatian: obavijestite osobu koja je naručila pretragu da uzimate Trobalt.
English: Don't drive or use machines until you know how Trobalt affects you.
Croatian: Nemojte upravljati vozilima ili strojevima dok ne utvrdite kako Trobalt djeluje na Vas.
English: Tell your doctor if any of these apply to you, or if you notice any unusual changes in your heart beat (such as beating too fast or too slow).
Croatian: Obavijestite svog liječnika ako se nešto od navedenog odnosi na Vas ili ako primijetite bilo kakve promjene otkucaja srca (poput prebrzog ili presporog kucanja).
English: Your doctor may decide that Trobalt is not suitable for you.
Croatian: Liječnik može odlučiti da Trobalt nije prikladan lijek za Vas.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28 March 2011
Croatian: Datum prvog odobrenja: 28. ožujka 2011.
English: Your doctor may gradually adjust your dose over a few weeks so that your seizures are better controlled, and side effects are kept to a minimum.
Croatian: Liječnik Vam može tijekom nekoliko tjedana postupno prilagođavati dozu kako bi napadaji bili pod boljom kontrolom, a nuspojave svedene na minimum.
English: The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for retigabine.
Croatian: Mehanizam djelovanja ovog rizika nije poznat te raspoloživi podaci ne isključuju mogućnost povećanog rizika za retigabin.
English: Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications.
Croatian: Suicidalne ideje i ponašanje zabilježeni su kod bolesnika liječenih antiepilepticima u nekoliko indikacija.
English: The cumulative incidences of an event at 1 year, 2 years, 3 years, 4 years and 5 years of exposure are approximately 1%, 1.8%, 4.4%, 10.2% and 16.7% respectively.
Croatian: Kumulativna incidencija događaja nakon 1, 2, 3, 4 odnosno 5 godina izloženosti iznosi približno 1%, 1,8%, 4,4%, 10,2% odnosno 16,7%.
English: How much to take
Croatian: Koliko lijeka uzimati
English: There was no effect on sleep time induced by halothane or methohexital sodium.
Croatian: Nije bilo učinka na vrijeme spavanja koje je bilo inducirano halotanom ili natrijevim metoheksitalom.
English: If you are over 65 years you will usually be given a reduced starting dose and your doctor may limit the maximum dose to 900 mg a day.
Croatian: Ako ste stariji od 65 godina, vjerojatno ćete dobiti manju početnu dozu, a liječnik Vam može ograničiti najvišu dozu na 900 mg na dan.
English: Uncertainties about the impact of this risk on patients remain as there is a possibility of functional abnormalities associated with retinopathy including potentially severe visual impairment.
Croatian: I dalje ostaju nejasnoće o utjecaju tog rizika na bolesnike, jer postoji mogućnost funkcionalnih abnormalnosti povezanih s retinopatijom uključujući potencijalno ozbiljno oštećenje vida.
English: Based upon the data that have become available since the granting of the initial Marketing Authorisation, the CHMP considers that the benefit-risk balance of Trobalt remains positive, but considers that its safety profile is to be closely monitored for the following reasons:
Croatian: Na temelju podataka koji su postali dostupni nakon prvog odobrenja za stavljanje u promet, CHMP smatra da je omjer koristi i rizika za lijek Trobalt ostao pozitivan, ali smatra da se njegov sigurnosni profil treba pažljivo pratiti zbog sljedećih razloga:
English: * Statistically significant, p≤0.05 ~ Dose not studied
Croatian: * Statistički značajno, p≤0,05
English: In addition, a single supplemental dose is recommended immediately after haemodialysis.
Croatian: Osim toga, preporučuje se uzimanje jedne dopunske doze neposredno nakon hemodijalize.
English: If you notice such changes while taking the medicine, tell your doctor.
Croatian: Ako primijetite takve promjene za vrijeme uzimanja ovog lijeka obratite se svom liječniku.
English: Trobalt is one of a group of medicines called antiepileptics.
Croatian: Trobalt je jedan od lijekova iz skupine antiepileptika.
English: It may take a few weeks to find the right dose of Trobalt for you.
Croatian: Možda će trebati nekoliko tjedana da bi se utvrdila doza lijeka Trobalt koja je odgovarajuća za Vas.
English: If you suddenly stop taking Trobalt, your seizures may come back or get worse.
Croatian: Ako prestanete uzimati Trobalt Ako iznenada prestanete uzimati Trobalt, napadaji se mogu vratiti ili pogoršati.