FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Semintra, telmisartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Croatian: Djelatna tvar u VMP-u Semintra, telmisartan, jest „antagonist receptora angiotenzina II”, što znači da blokira djelovanje hormona angiotenzina II u tijelu.
English: At the end of the 28 days Semintra treated cats continued to be treated for an additional 92 days and these cats had a reduction of SBP of more than 20 mmHg for the entire 4 month study period.
Croatian: Nakon 28 dana, liječenje mačaka liječenih VMP-om Semintra nastavilo se dodatna 92 dana te je u tih mačaka zabilježeno sniženje SBP-a veće od 20 mmHg tijekom cijelog razdoblja ispitivanja u trajanju od četiri mjeseca.
English: In a field study involving 224 cats with chronic kidney disease, aged mainly over 11 years, Semintra was as effective as benazepril, another veterinary medicine used to reduce proteinuria, in reducing proteinuria.
Croatian: U terenskom ispitivanju koje je obuhvaćalo 224 mačke s kroničnom bubrežnom bolešću, uglavnom starije od 11 godina, VMP Semintra bio je jednako učinkovit u smanjenju proteinurije kao benazepril,
English: By blocking the receptor to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood vessels to expand.
Croatian: Telmisartan blokiranjem receptora na koje se angiotenzin II inače veže sprječava djelovanje tog hormona, čime se omogućuje širenje krvnih žila.
English: Semintra is available as a solution to be given by mouth and can only be obtained with a veterinary prescription.
Croatian: VMP Semintra dostupan je kao otopina koja se primjenjuje peroralno i izdaje se samo na veterinarski recept.
English: How is Semintra used?
Croatian: Kako se Semintra koristi?
English: The recommended dose to reduce proteinuria is 1 mg telmisartan per kg bodyweight.
Croatian: Preporučena je doza za smanjenje proteinurije 1 mg telmisartana po kg tjelesne težine.
English: What benefits of Semintra have been shown in studies?
Croatian: Koje su koristi VMP-a Semintra utvrđene u ispitivanjima?
English: The person administering Semintra should avoid getting it in their eyes.
Croatian: Osoba koja primjenjuje VMP Semintra treba izbjegavati da VMP dođe u doticaj s očima.
English: For a full list of all side effects reported with Semintra, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih prilikom primjene VMP-a Semintra potražite u uputi o VMP-u.
English: How does Semintra work?
Croatian: Kako djeluje Semintra?
English: (Best response rate)
Croatian: (Stopa najboljeg odgovora)
English: More frequent follow-up of these patients should be considered.
Croatian: Potrebno je razmotriti češće praćenje ovih bolesnika.
English: This study is ongoing.
Croatian: Ovo ispitivanje je u tijeku.
English: Date of first authorisation: 19 November 2007 Date of latest renewal: 19 November 2012
Croatian: Datum prvog odobrenja: 19. studenog 2007. Datum posljednje obnove odobrenja: 19. studenog 2012.
English: - Risk Management Plan (RMP)
Croatian: • Plan upravljanja rizikom (RMP)
English: Taking Tasigna at the same time each day will help you remember when to take your hard capsules.
Croatian: Uzimanje Tasigne svaki dan u isto vrijeme će Vam pomoći da zapamtiti kada trebate uzeti tvrde kapsule.
English: At risk : Events
Croatian: Pod rizikom: događaji
English: Sudden death
Croatian: Iznenadna smrt
English: This is a long-term treatment.
Croatian: Ovo je dugotrajno liječenje.
English: - Do not open the hard capsules unless you are unable to swallow them.
Croatian: - Ne otvarajte tvrde kapsule, osim ako ih ne možete progutati.
English: If you take more Tasigna than you should
Croatian: Ako uzmete više Tasigne nego što ste trebali
English: These changes are unlikely to be clinically important.
Croatian: Nije vjerojatno da su ove promjene klinički značajne.
English: Medical treatment may be necessary.
Croatian: Možda će biti potrebno liječenje.
English: Some children and adolescents taking Tasigna may have slower than normal growth.
Croatian: Kod neke djece i adolescenata koji uzimaju Tasignu rast može biti sporiji od normalnog.
English: Unexpected, rapid weight gain should be carefully investigated.
Croatian: Neočekivani, brzi porast tjelesne težine treba pažljivo istražiti.
English: Do not drink grapefruit juice or eat grapefruit.
Croatian: Nemojte piti sok od grejpa ili jesti grejp.
English: The doctor will calculate the correct dose to use and tell you which and how many capsules of Tasigna to give to your child.
Croatian: Liječnik će izračunati točnu dozu i reći Vam koje i koliko kapsula Tasigne trebate dati svom djetetu.
English: No ECG changes or hepatotoxicity were reported.
Croatian: Nisu bile prijavljene promjene EKG-a ili hepatotoksičnost.
English: Treatment-free Survival (%)
Croatian: Preživljenje bez liječenja (%)
English: The total daily dose you give to your child must not exceed 800 mg.
Croatian: Ukupna dnevna doza koju dajete djetetu ne smije premašiti 800 mg.
English: **Also includes preferred term anorexia
Croatian: **Uključuje i preporučeni pojam anoreksija
English: Use in children and adolescents - The dose given to your child will depend on your child's body weight and height.
Croatian: Primjena u djece i adolescenata - Doza koja se daje Vašem djetetu ovisit će o djetetovoj tjelesnoj težini i visini.
English: Months since randomisation
Croatian: Mjeseci nakon randomizacije
English: This medicine contains lactose (also known as milk sugar).
Croatian: Ovaj lijek sadrži laktozu (poznatu kao mliječni šećer).
English: Continue taking Tasigna every day for as long as your doctor tells you.
Croatian: Nastavite uzimati Tasignu svaki dan toliko dugo koliko Vam je rekao Vaš liječnik.
English: 60-month analysis
Croatian: 60-mjesečna analiza
English: Your doctor may prescribe a lower dose depending on how you respond to treatment.
Croatian: Vaš liječnik može propisati nižu dozu ovisno o tome kako reagirate na liječenje.
English: Treatment should be continued as long as clinical benefit is observed or until unacceptable toxicity occurs.
Croatian: Liječenje treba nastaviti dokle god se uočava klinička korist ili dok ne dođe do neprihvatljive toksičnosti.
English: Tasigna is available in the following pack sizes:
Croatian: Tasigna je dostupna u sljedećim pakiranjima:
English: Rifampicin and nilotinib should not be used concomitantly.
Croatian: Rifampicin i nilotinib se ne smiju istodobno koristiti.
English: The presence of hypokalaemia and hypomagnesaemia may further enhance this effect.
Croatian: Hipokalijemija i hipomagnezijemija mogu također pojačati ovaj učinak.
English: Older people (age 65 years and over) Tasigna can be used by people aged 65 years and over at the same dose as for other adults.
Croatian: Starije osobe (65 godina i starije) Tasignu mogu uzimati osobe u dobi od 65 godina i više u istoj dozi kao ostale odrasle osobe.
English: Do not stop taking this medicine unless your doctor tells you to do so.
Croatian: Nemojte prestati uzimati ovaj lijek, osim ako Vam to ne kaže Vaš liječnik.
English: These medicines should be avoided during your treatment with Tasigna.
Croatian: Ove lijekove treba izbjegavati tijekom Vašeg liječenja Tasignom.
English: Patients should be advised to seek immediate medical attention if they experience acute signs or symptoms of cardiovascular events.
Croatian: Bolesnicima treba savjetovati da odmah potraže liječničku pomoć ako primijete akutne znakove ili simptome kardiovaskularnih događaja.
English: Dose adjustments or modifications
Croatian: Prilagođavanja ili izmjene doze
English: Take the hard capsules: - twice a day (approximately every 12 hours); - at least 2 hours after any food; - then wait 1 hour before eating again.
Croatian: Uzmite tvrde kapsule: - dva puta na dan (otprilike svakih 12 sati); - najmanje 2 sata nakon bilo koje hrane; - onda pričekajte 1 sat prije sljedećeg obroka.
English: In addition, the toxicity profile in juvenile rats was comparable to that observed in adult rats.
Croatian: Osim toga, profil toksičnosti je bio usporediv s onim opaženim u odraslih štakora.
English: Laboratory tests and monitoring
Croatian: Laboratorijske pretrage i praćenje
English: Do not take Tasigna - if you are allergic to nilotinib or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Tasignu - ako ste alergični na nilotinib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: - Do not take any food together with the hard capsules.
Croatian: - Ne uzimajte hranu zajedno s tvrdim kapsulama.
English: If you have taken more Tasigna than you should have, or if someone else accidentally takes your hard capsules, contact a doctor or hospital for advice straight away.
Croatian: Ako ste uzeli više Tasigne nego što ste trebali, ili ako je netko drugi slučajno uzeo Vaše tvrde kapsule, odmah kontaktirajte liječnika ili bolnicu za savjet.
English: They may differ from the general information contained in this leaflet.
Croatian: One se mogu razlikovati od općenitih uputa koje su navedene u ovoj uputi.
English: Only patients who were in MMR at a specific time point are included as responders for that time point.
Croatian: Samo oni bolesnici koji su imali MMR u određenoj vremenskoj točki uključeni su kao osobe s odgovorom za tu vremensku točku.
English: 24-month analysis
Croatian: 24-mjesečna analiza
English: No deaths were reported on treatment or after treatment discontinuation in both studies.
Croatian: Nije bio prijavljen nijedan smrtni slučaj za vrijeme liječenja ili nakon obustave liječenja u oba ispitivanja.
English: The doctor will monitor growth at regular visits.
Croatian: Liječnik će pratiti rast prilikom redovitih pregleda.
English: Tasigna has no or negligible influence on the ability to drive and use machines.
Croatian: Tasigna nema ili ima zanemarivi utjecaj na sposobnost upravljanja vozilom i rada sa strojevima.
English: Nilotinib did not have effects on CNS or respiratory functions.
Croatian: Nilotinib nema učinaka na CNS ni na respiratorne funkcije.
English: Prior interferon
Croatian: Prethodno interferon
English: Main metabolic pathways identified in healthy subjects are oxidation and hydroxylation.
Croatian: Glavni metabolički putevi u zdravih ispitanika su oksidacija i hidroksilacija.
English: Stopping Tasigna without your doctor's recommendation places you at risk for worsening of your disease which could have life-threatening consequences.
Croatian: Prestanak uzimanja Tasigne bez preporuke liječnika izlaže Vas riziku pogoršanja bolesti, što može imati po život opasne posljedice.
English: Forty patients (58.0%) had relative dose intensity superior to 90%.
Croatian: Četrdeset bolesnika (58,0%) imalo je relativni intenzitet doze iznad 90%.
English: If test results warrant therapy, physicians should follow their local standards of practice and treatment guidelines.
Croatian: Ako nalazi pretraga opravdavaju terapiju, liječnici trebaju slijediti svoje lokalne standarde prakse i smjernice za liječenje.
English: Other medicines and Tasigna Tasigna may interfere with some other medicines.
Croatian: Drugi lijekovi i Tasigna Tasigna može ući u interakciju s drugim lijekovima.
English: In general the changes in clinical chemistry were fully reversible after a four-week recovery period and the histological alterations showed partial reversibility.
Croatian: Općenito su promjene biokemijskih parametara bile potpuno reverzibilne nakon razdoblja oporavka od 4 tjedna, dok su histološke promjene bile djelomično reverzibilne.
English: What Tasigna is and what it is used for What you need to know before you take Tasigna How to take Tasigna
Croatian: Što je Tasigna i za što se koristi Što morate znati prije nego počnete uzimati Tasignu Kako uzimati Tasignu
English: Tasigna should be taken twice daily approximately 12 hours apart and must not be taken with food.
Croatian: Tasignu treba uzimati dva puta na dan u razmaku od približno 12 sati i ne smije se uzimati s hranom.
English: If it is used during pregnancy, the patient must be informed of the potential risk to the foetus.
Croatian: Ako se primjenjuje tijekom trudnoće, bolesnica se mora obavijestiti o mogućem riziku za fetus.
English: Molecular relapse can occur during the treatment-free phase, and long-term outcome data are not yet available.
Croatian: Tijekom faze bez liječenja može se dogoditi molekularni relaps, a podaci o dugoročnom ishodu još nisu dostupni.
English: Toxic hepatitis
Croatian: Toksični hepatitis
English: - if you are being treated with medicines that affect the heart beat (anti-arrhythmics) or the liver (see Other medicines and Tasigna).
Croatian: - ako se liječite lijekovima koji utječu na srčani ritam (antiaritmici) ili jetru (vidjeti Drugi lijekovi i Tasigna).
English: The primary efficacy endpoint was major molecular response (MMR) at 12 months.
Croatian: Primarni ishod djelotvornosti bio je veliki molekularni odgovor (MMR - engl. major molecular response) u 12. mjesecu.
English: These adverse reactions are included based on clinical relevance.
Croatian: Te nuspojave uključene su na temelju kliničke značajnosti.
English: The heart rate will also be checked using a machine that measures electrical activity of the heart (a test called an “ECG”).
Croatian: Provjeravat će se i srčana frekvencija pomoću uređaja koji mjeri električnu aktivnost srca (pretraga koje se zove „EKG“).
English: Median duration of MCyR was 32.7 months.
Croatian: Medijan trajanja MCyR-a je bio 32,7 mjeseci.
English: Only minor liver alterations were seen in mice or rats treated for up to 26 weeks.
Croatian: Zapažene su samo manje jetrene promjene u miševa i štakora liječenih do 26 tjedana.
English: Your doctor may consider discontinuing your treatment with Tasigna based on specific criteria.
Croatian: Vaš liječnik može razmotriti prekid liječenja Tasignom na temelju specifičnih kriterija.
English: If you think you may be allergic, tell your doctor before taking Tasigna.
Croatian: Ako mislite da biste mogli biti alergični, obavijestite svog liječnika prije uzimanja Tasigne.
English: Tasigna blocks this signal, and thus stops the production of these cells.
Croatian: Tasigna blokira taj signal te tako sprječava proizvodnju leukemijskih stanica.
English: This is because Tasigna could cause hepatitis B to become active again, which can be fatal in some cases.
Croatian: To je potrebno jer Tasigna može uzrokovati ponovnu aktivaciju hepatitisa B što u nekim slučajevima može rezultirati smrtnim ishodom.
English: If you miss a dose, take your next dose as scheduled.
Croatian: Ako ste propustili uzeti dozu, uzmite sljedeću dozu kako je propisano.
English: *ANC = absolute neutrophil count
Croatian: * ABN = apsolutni broj neutrofila
English: Plasma protein binding is approximately 98% on the basis of in vitro experiments.
Croatian: Vezanje za proteine plazme je približno 98% temeljeno na podacima iz in vitro istraživanja.
English: In the event of overdose, the patient should be observed and appropriate supportive treatment given.
Croatian: U slučaju predoziranja, bolesnika treba pratiti i pružiti mu odgovarajuće suportivno liječenje.
English: The primary data analysis time point was when all 846 patients completed 12 months of treatment (or discontinued earlier).
Croatian: Vrijeme analize primarnih podataka bilo je kada je svih 846 bolesnika završilo 12 mjeseci liječenja (ili su ga ranije prekinuli).
English: No effects were seen in ECG measurements in dogs or monkeys treated for up to 39 weeks or in a special telemetry study in dogs.
Croatian: Nisu zabilježeni učinci na mjerenja EKG-a u pasa ili majmuna liječenih do 39 tjedana ili u posebnom telemetrijskom ispitivanju u pasa.
English: Approximately 12% of subjects in the clinical study were 65 years of age or over.
Croatian: Približno 12% ispitanika u kliničkom ispitivanju bilo je u dobi od 65 godina ili više.
English: Patients were within six months of diagnosis and were previously untreated, with the exception of hydroxyurea and/or anagrelide.
Croatian: Bolesnicima je dijagnoza bila postavljena unutar šest mjeseci i nisu prethodno bili liječeni, uz izuzetak hidroksiureje i/ili anagrelida.
English: What Tasigna is and what it is used for
Croatian: Što je Tasigna i za što se koristi
English: Elevation in serum lipase has been observed.
Croatian: Opaženo je povećanje vrijednosti serumske lipaze.
English: The AUC of imatinib was increased by 18% to 39%, and the AUC of nilotinib was increased by 18% to 40%.
Croatian: AUC imatiniba je bio povećan za 18% do 39%, a AUC nilotiniba je bio povećan za 18% do 40%.
English: Baseline characteristics were well balanced between the three treatment arms.
Croatian: Karakteristike na početku su bile dobro uravnotežene između tri skupine liječenja.
English: Subsequent analyses reflect when patients completed 24, 36, 48, 60 and 72 months of treatment (or discontinued earlier).
Croatian: Naknadne analize uključuju podatke kada su bolesnici završili 24, 36, 48, 60 i 72 mjeseca liječenja (ili su ga ranije prekinuli).
English: Median duration of MCyR has not been reached.
Croatian: Medijan trajanja MCyR-a nije dostignut.
English: The median time on treatment was approximately 70 months in the nilotinib treatment groups and 64 months in the imatinib group.
Croatian: Medijan vremena liječenja bio je otprilike 70 mjeseci u terapijskoj skupini s nilotinibom i 64 mjeseca u skupini s imatinibom.
English: Among these 88 patients, 86 patients restarted nilotinib treatment and 2 patients permanently discontinued the study.
Croatian: Od tih 88 bolesnika, 86 bolesnika ponovno je započelo liječenje nilotinibom, a 2 bolesnika su trajno prekinula ispitivanje.
English: Prolongation of the QT interval or an irregular heart beat may lead to sudden death.
Croatian: Produženje QT intervala ili nepravilni otkucaji srca mogu dovesti do iznenadne smrti.
English: Tasigna should not be used during pregnancy unless the clinical condition of the woman requires treatment with nilotinib.
Croatian: Tasigna se ne smije primjenjivati u trudnoći, osim ako kliničko stanje žene ne zahtijeva liječenje nilotinibom.
English: Table 5 Grade 3-4 laboratory abnormalities*
Croatian: Tablica 5 Laboratorijske abnormalnosti 3.-4. stupnja*
English: In paediatric patients, treatment must be interrupted until the event returns to Grade 1.
Croatian: U pedijatrijskih bolesnika liječenje se mora prekinuti dok se događaj ne vrati na ≤1. stupanj.
English: Most of the side effects are mild to moderate and will generally disappear after a few days to a few weeks of treatment.
Croatian: Nuspojave su obično blage do umjerene i u pravilu nestaju nakon nekoliko dana do nekoliko tjedana liječenja.
English: Censored observations
Croatian: Cenzurirana opažanja
English: Do not use more than one teaspoon of apple sauce for each hard capsule and do not use any food other than apple sauce.
Croatian: Nemojte uzeti više od jedne čajne žličice kaše od jabuke za svaku tvrdu kapsulu i nemojte uzeti niti jednu drugu hranu osim kaše od jabuke.
English: If you are the parent of a child who is being treated with Tasigna, tell the doctor if any of the above conditions apply to your child.
Croatian: Ako ste roditelj djeteta koje se liječi Tasignom, obavijestite liječnika ako se bilo što od navedenoga odnosi na Vaše dijete.
English: Juvenile animal studies
Croatian: Ispitivanja u mladih životinja
English: Your doctor should assess the level of fats (lipids) and sugar in your blood before initiating treatment with Tasigna and during treatment.
Croatian: Vaš liječnik treba ocijeniti razinu masnoća (lipida) i šećera u Vašoj krvi prije nego što započnete liječenje Tasignom i tijekom liječenja.
English: Eligible patients who are confirmed to express the typical BCR-ABL transcripts, e13a2/b2a2 or e14a2/b3a2, can be considered for treatment discontinuation.
Croatian: Podobni bolesnici za koje je potvrđeno da eksprimiraju tipične BCR-ABL transkripcije, e13a2/b2a2 ili e14a2/b3a2, mogu se uzeti u obzir za prekid liječenja.
English: CML is a cancer of the blood which makes the body produce too many abnormal white blood cells.
Croatian: KML je rak krvi kod kojeg tijelo stvara previše abnormalnih bijelih krvnih stanica.
English: Events included neutropenia, vomiting and drowsiness.
Croatian: Događaji su uključivali neutropeniju, povraćanje i pospanost.
English: The pharmacokinetic exposure of nilotinib following a single or multiple doses appeared to be comparable between paediatric patients from 2 years to <10 years and from ≥10 years to <18 years.
Croatian: Farmakokinetička izloženost nilotinibu nakon jednokratne ili višestrukih doza činila se usporedivom između pedijatrijskih bolesnika u dobi od 2 godine do <10 godina i od ≥10 godina do <18 godina.
English: Nilotinib is the main circulating component in the serum.
Croatian: Nilotinib je glavna komponenta koja cirkulira u serumu.
English: Dose in mg (twice daily)
Croatian: Doza u mg (dva puta na dan)
English: Complete blood counts should be performed every two weeks for the first 2 months and then monthly thereafter, or as clinically indicated.
Croatian: Kompletnu krvnu sliku treba kontrolirati svaka dva tjedna tijekom prva 2 mjeseca te zatim jednom mjesečno ili kada je klinički indicirano.
English: Women of childbearing potential/Contraception
Croatian: Žene reproduktivne dobi/Kontracepcija
English: Different strengths of Tasigna hard capsules can be combined to attain the desired dose.
Croatian: Tasigna tvrdih kapsula mogu se kombinirati da bi se postigla željena doza.
English: There is no experience with the use of this medicine in children below 2 years of age.
Croatian: Nema iskustva s primjenom ovoga lijeka u djece mlađe od 2 godine.
English: Metabolism and nutrition disorders Decreased appetite **
Croatian: Poremećaji metabolizma i prehrane Smanjeni apetit **
English: As compared to an oral drink solution (pH of 1.2 to 1.3), relative bioavailability of nilotinib capsule is approximately 50%.
Croatian: U usporedbi s oralnom otopinom za piće (pH od 1,2 do 1,3) relativna bioraspoloživost kapsule nilotiniba otprilike je 50%.
English: MCyR rate was 30% with a median time to response of 2.8 months.
Croatian: Stopa MCyR-a je bila 30% uz medijan vremena do odgovora od 2,8 mjeseci.
English: Table 12 Response in CML
Croatian: Tablica 12 Odgovor kod KML-a
English: This dose is achieved by taking two hard capsules of
Croatian: Ta doza se postiže uzimanjem dvije tvrde kapsule od
English: Median time since diagnosis in months (range)
Croatian: Medijan vremena od dijagnoze u mjesecima (raspon)
English: - Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.
Croatian: - Ovaj lijek se ne smije upotrijebiti ako primijetite da je kutija oštećena ili su vidljivi znakovi otvaranja.
English: The median time to achieve CCyR was just past 3 months (median 3.4 months).
Croatian: Medijan vremena za postizanje CCyR-a je nešto više od 3 mjeseca (medijan 3,4 mjeseca).
English: Growth retardation in paediatric population
Croatian: Zastoj u rastu u pedijatrijskoj populaciji
English: These medicines need to be taken separately from Tasigna: - H2 blockers, which decrease the production of acid in the stomach.
Croatian: Ove je lijekove potrebno uzimati odvojeno od Tasigne: - blokatori H2 receptora, koji smanjuju stvaranje kiseline u želucu.
English: Mainly reversible increases in cholesterol levels were seen in rats, dogs and monkeys.
Croatian: Uglavnom reverzibilno povećanje razine kolesterola zapaženo je u štakora, pasa i majmuna.
English: Accelerated phase
Croatian: Ubrzana faza
English: Tasigna was administered on a continuous basis (twice daily 2 hours after a meal and with no food for at least one hour after administration) unless there was evidence of inadequate response or disease progression.
Croatian: Tasigna se primjenjivala kontinuirano (dva puta na dan, 2 sata nakon obroka i bez uzimanja hrane najmanje jedan sat nakon primjene), osim ako nije utvrđen neodgovarajući odgovor na liječenje ili ako je došlo do progresije bolesti.
English: - Do not use this medicine after the expiry date which is stated on the carton and blister.
Croatian: - Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru.