FrancophonIA/ELRC3.0 huggingface dataset:
English: LysaKare is given by infusion (drip) in to a vein over 4 hours.
Croatian: LysaKare se primjenjuje intravenskom infuzijom (ukapavanjem) u trajanju od četiri sata.
English: The most common side effects with LysaKare (which may affect more than 1 in 10 people) are nausea and vomiting.
Croatian: Najčešće nuspojave lijeka LysaKare (koje se mogu javiti u više od 1 na 10 osoba) jesu mučnina i povraćanje.
English: LysaKare can only be obtained with a prescription and should only be given by a healthcare professional experienced in the use of radioactive medicines.
Croatian: LysaKare se izdaje samo na recept, a smije ga davati samo zdravstveni radnik s iskustvom u primjeni radioaktivnih lijekova.
English: The European Medicines Agency therefore decided that LysaKare's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove stoga je zaključila da koristi od lijeka LysaKare nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: As a result, the radioactive medicine leaves the body in the urine and the kidneys are exposed to less radiation.
Croatian: Kao posljedica toga, radioaktivni lijek izlučuje se iz tijela urinom, a bubrezi su izloženi manjoj količini zračenja.
English: Side effects reported with LysaKare are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek LysaKare pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of LysaKare 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 LysaKare nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: As for all medicines, data on the use of LysaKare are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka LysaKare kontinuirano se prate.
English: LysaKare (arginine / lysine) EMA/378037/2019
Croatian: LysaKare (arginin/lizin) EMA/314645/2019
English: An overview of LysaKare and why it is authorised in the EU
Croatian: Pregled informacija o lijeku LysaKare i zašto je odobren u EU-u
English: LysaKare must not be given to patients with high levels of potassium in the blood if this has not been corrected before treatment.
Croatian: LysaKare se ne smije davati bolesnicima s visokom razinom kalija u krvi ako razina nije smanjena prije početka liječenja.
English: Because the use of arginine and lysine to protect the kidneys during this type of cancer treatment is well established, the company presented data from the scientific literature.
Croatian: Budući da je primjena arginina i lizina radi zaštite za bubrege tijekom ove vrste liječenja raka dobro poznata, tvrtka je predstavila podatke iz znanstvene literature.
English: Why is LysaKare authorised in the EU?
Croatian: Zašto je lijek LysaKare odobren u EU-u?
English: What are the risks associated with LysaKare?
Croatian: Koji su rizici povezani s lijekom LysaKare?
English: The main risk with LysaKare is a dangerous rise of blood potassium levels but this side effect can be managed if recognised and treated appropriately.
Croatian: Glavni rizik povezan s primjenom lijeka LysaKare jest opasan porast razine kalija u krvi, ali ta se nuspojava može kontrolirati ako se prepozna i liječi na odgovarajući način.
English: LysaKare is for use in adults and contains the active substances arginine and lysine.
Croatian: LysaKare se primjenjuje u odraslih osoba i sadrži djelatne tvari arginin i lizin.
English: LysaKare is also associated with hyperkalaemia (high blood potassium levels), but the frequency of this side effect is not known.
Croatian: Lijek LysaKare povezuje se i s hiperkalijemijom (visokom razinom kalija u krvi), ali učestalost ove nuspojave nije poznata.
English: For more information about using LysaKare, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka LysaKare pročitajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
English: How does LysaKare work?
Croatian: Kako djeluje LysaKare?
English: In another published study involving 229 patients, measurement of creatinine clearance (an indication of how well the kidneys are working) did not show kidney damage 14 months after patients were treated with arginine and lysine at the same time as lutetium (177Lu) oxodotreotide.
Croatian: U drugom objavljenom ispitivanju na 229 bolesnika, mjerenje klirensa kreatinina (pokazatelja kvalitete funkcioniranja bubrega) nije pokazalo oštećenje bubrega 14 mjeseci nakon liječenja bolesnika argininom i lizinom istodobno uz liječenje lutecijevim (177Lu) oksodotreotidom.
English: Infusion with LysaKare is started 30 minutes before the patient is given lutetium (177Lu) oxodotreotide (also by infusion).
Croatian: Infuzija lijekom LysaKare počinje 30 minuta prije nego što bolesnik primi lutecijev (177Lu) oksodotreotid (također putem infuzije).
English: What benefits of LysaKare have been shown in studies?
Croatian: Koje su koristi od lijeka LysaKare utvrđene u ispitivanjima?
English: LysaKare is a medicine used to protect the kidneys from radiation damage during cancer treatment with a radioactive medicine called lutetium (177Lu) oxodotreotide.
Croatian: LysaKare je lijek koji se primjenjuje za zaštitu bubrega od oštećenja uzrokovanih zračenjem tijekom liječenja raka radioaktivnim lijekom lutecijevim (177Lu) oksodotreotidom.
English: These included data from over 1,200 cancer patients treated with lutetium (177Lu) oxodotreotide, which showed that arginine and lysine were effective at preventing kidney damage.
Croatian: Podatci su se odnosili na više od 1 200 bolesnika oboljelih od raka koji su liječeni lutecijevim (177Lu) oksodotreotidom, a pokazali su da arginin i lizin učinkovito sprječavaju oštećenja bubrega.
English: Side effects with LysaKare are usually mild or moderate.
Croatian: Nuspojave lijeka LysaKare obično su blage do umjerene.
English: For the full list of side effects and restrictions with LysaKare, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja povezanih s lijekom LysaKare potražite u uputi o lijeku.
English: The active substances in LysaKare, arginine and lysine, interfere with the passage of lutetium (177Lu) oxodotreotide through these kidney tubules.
Croatian: Djelatne tvari lijeka LysaKare, arginin i lizin, ometaju prolazak lutecijeva (177Lu) oksodotreotida kroz te bubrežne kanaliće.
English: Radiation from lutetium (177Lu) oxodotreotide can cause damage when the medicine passes through tubules in the kidney.
Croatian: Zračenje lutecijeva (177Lu) oksodotreotida može uzrokovati oštećenja prilikom prolaska lijeka kroz bubrežne kanaliće.
English: The use of arginine and lysine during treatment with lutetium (177Lu) oxodotreotide has been shown to reduce kidney damage and allow patients to be given an effective dose of radioactive treatment for their cancer.
Croatian: Utvrđeno je da primjena arginina i lizina tijekom liječenja lutecijevim (177Lu) oksodotreotidom smanjuje oštećenja bubrega te omogućuje bolesnicima da prime učinkovitu dozu radioterapije za liječenje raka.
English: How is LysaKare used?
Croatian: Kako se LysaKare primjenjuje?
English: Information on how to do this has been included in the product information.
Croatian: Više informacija o kontroliranju te nuspojave potražite u informacijama o lijeku.
English: * further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open-label extension studies 1) including spontaneous reporting data
Croatian: * detaljnije informacije mogu se pronaći u dijelovima 4.3, 4.4 i 4.8 ** uključujući otvorene produžetke ispitivanja 1) uključujući podatke iz spontanog prijavljivanja
English: Other medicines and SOLYMBIC
Croatian: Drugi lijekovi i SOLYMBIC
English: It is a medicine that decreases the inflammation process of these diseases.
Croatian: To je lijek koji smanjuje upalni proces u ovim bolestima.
English: If you forget to give yourself an injection, you should inject it as soon as you remember.
Croatian: Zaboravite li primijeniti injekciju, morate ju primijeniti čim to primijetite.
English: Mean exposure in all adalimumab population was 762 days.
Croatian: Prosječna izloženost u cjelokupnoj populaciji na adalimumabu iznosila je 762 dana.
English: Monoclonal antibodies are proteins that recognise and bind to other unique proteins.
Croatian: Monoklonska protutijela su proteini koji prepoznaju druge jedinstvene proteine i za njih se vežu.
English: SOLYMBIC can also be given alone.
Croatian: SOLYMBIC se može primjenjivati i sam.
English: If you use more SOLYMBIC than you should
Croatian: Ako primijenite više lijeka SOLYMBIC nego što ste trebali
English: • Signs or symptoms of the safety concern and when to seek attention from a HCP
Croatian: • Znakovi ili simptomi sigurnosnih problema i kada potražiti pomoć zdarvstvenog radnika
English: What SOLYMBIC is and what it is used for
Croatian: Što je SOLYMBIC i za što se koristi
English: The MAH shall ensure that in each Member State where Solymbic is marketed, all healthcare professionals who are expected to prescribe Solymbic have are provided with the following educational package:
Croatian: Nositelj odobrenja će osigurati da, u svim zemljama u kojima je Solymbic u prometu, svi zdravstveni radnici za koje se očekuje da propisuju lijek Solymbic, dobiju sljedeće edukacijske pakete:
English: Patients above 4 years of age but with a weight less than 23 kg or between 29 and 46 kg are not possible to dose with this product.
Croatian: Bolesnike starije od 4 godine, ali težine manje od 23 kg ili između 29 i 46 kg nije moguće liječiti ovim lijekom.
English: Prior to launch of Solymbic in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Croatian: Prije stavljanja lijeka Solymbic u promet u svakoj državi članici, nositelj odobrenja mora dogovoriti s nacionalnim nadležnim tijelom sadržaj i format edukacijskog programa, uključujući komunikacijske medije, načine distribucije i sve ostale aspekte programa.
English: Results from the overall UC-II study population are shown in table 22.
Croatian: Rezultati za ukupnu populaciju iz ispitivanja UC-II prikazani su u Tablici 22.
English: ASDAS Inactive Disease hs-CRP
Croatian: ASDAS neaktivna bolest hs-CRP
English: Talk to your doctor or pharmacist before using SOLYMBIC:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primijenite lijek SOLYMBIC:
English: Double-Blind Response at week
Croatian: Dvostruko slijepo, odgovor u 12. tjednu
English: Sodium hydroxide (for pH adjustment) Water for injections
Croatian: Natrijev hidroksid (za podešavanje pH) Voda za injekcije
English: TNF-antagonists, such as SOLYMBIC affect the immune system and their use may affect the body's defence against infection and cancer.
Croatian: Antagonisti TNF-a, kao što je SOLYMBIC, djeluju na imunološki sustav te njihova primjena može utjecati na obranu tijela od infekcija i raka.
English: You and your doctor should pay special attention to signs of infection while you are being treated with SOLYMBIC.
Croatian: I Vi i Vaš liječnik morate obratite posebnu pažnju na znakove infekcije dok se liječite lijekom SOLYMBIC.
English: Significant response was first observed at week 2 and maintained through 24 weeks (table 8).
Croatian: To se poboljšanje prvi put uočilo u drugom tjednu i održalo se 24 tjedna (Tablica 8).
English: a HR of adalimumab versus placebo from proportional hazards regression with treatment as factor.
Croatian: HR za adalimumab naspram placeba iz regresije proporcionalnih hazarda, uz liječenje kao faktor.
English: The volume for injection is selected based on the patients' height and weight (table 1).
Croatian: Volumen za injekciju se određuje na temelju visine i težine bolesnika (Tablica 1).
English: If you have rheumatoid arthritis and you do not receive methotrexate with your SOLYMBIC therapy, your doctor may decide to give 40 mg every week.
Croatian: Ako imate reumatoidni artritis i ne dobivate metotreksat zajedno s lijekom SOLYMBIC, Vaš liječnik može odlučiti davati Vam 40 mg svaki tjedan.
English: Your child's doctor will tell you the correct dose to use.
Croatian: Liječnik Vašeg djeteta reći će Vam točnu dozu koju trebate primijeniti.
English: Keep this Patient Alert Card with you.
Croatian: Karticu s upozorenjima za bolesnika držite kod sebe.
English: Re-introduction of SOLYMBIC after discontinuation for 70 days or longer should result in the same magnitudes of clinical response and similar safety profile as before dose interruption.
Croatian: Ponovno uvođenje lijeka SOLYMBIC nakon prekida od 70 dana ili duže trebalo bi rezultirati jednako jakim kliničkim odgovorom i sličnim sigurnosnim profilom kao i primjena prije prekida terapije.
English: If you become pregnant, you should consult your doctor.
Croatian: Ako zatrudnite, savjetujte se sa svojim liječnikom.
English: Table 15 Efficacy results at 12 weeks, HS studies I and II
Croatian: Tablica 15 Rezultati djelotvornosti nakon 12 tjedana, ispitivanja HS I i II
English: Not known (frequency cannot be estimated from available data): • liver failure.
Croatian: Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka): • zatajenje jetre.
English: Alternatively, if a patient has stopped SOLYMBIC and signs and symptoms of disease recur, SOLYMBIC may be re-administered.
Croatian: Alternativno, ako je bolesnik prestao uzimati lijek SOLYMBIC, a znakovi i simptomi bolesti su se opet pojavili, SOLYMBIC se može ponovno primijeniti.
English: • That Solymbic treatment may increase the potential risks of serious infections, sepsis,
Croatian: • Da liječenje lijekom Solymbic može povećati potencijalne rizike od ozbiljnih infekcija, sepse,
English: Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leucocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 0.1-0.2 nM).
Croatian: Adalimumab također modulira biološke odgovore koje inducira ili regulira TNF, uključujući promjene u razinama adhezijskih molekula koje su odgovorne za migraciju leukocita (ELAM-1, VCAM-1 i ICAM-1 s IC50 od 0,1-0,2 nM).
English: The Guide for healthcare professionals shall contain the following key elements:
Croatian: Upute za zdravstvene radnike trebaju sadržavati sljedeće ključne elemente:
English: Placebo/MTXadalimumab /MTX (95% confidence interval b)
Croatian: Placebo/MTXadalimumab/MTX (95% interval pouzdanosti b)
English: Week 52 Fistula remission
Croatian: 52. tjedan Remisija fistula
English: The impact of long-term treatment with SOLYMBIC on the development of autoimmune diseases is unknown.
Croatian: Utjecaj dugotrajnog liječenja lijekom SOLYMBIC na razvoj autoimunih bolesti nije poznat.
English: The decision to stop using SOLYMBIC should be discussed with your doctor.
Croatian: Odluku o prekidu primjene lijeka SOLYMBIC potrebno je raspraviti sa svojim liječnikom.
English: Children or adolescents weighing 40 kg or more:
Croatian: Djeca ili adolescenti tjelesne težine 40 kg ili više:
English: Asthma,
Croatian: • astma,
English: • Guide for healthcare professionals
Croatian: • Upute za zdravstvene radnike
English: * Maximum single dose is 40 mg (0.8 mL)
Croatian: * Maksimalna pojedinačna doza je 40 mg (0,8 ml)
English: For all of the above indications, available data suggest that the clinical response is usually achieved within 12 weeks of treatment.
Croatian: Za sve gore navedene indikacije, dostupni podaci pokazuju da se klinički odgovor obično postiže unutar 12 tjedana liječenja.
English: • A warning message for HCPs treating the patient at any time, including in conditions of emergency, that the patient is using Solymbic.
Croatian: • Upozorenje za zdravstvenog radnika koji liječi bolesnika u bilo kojem trenutku, uključujući hitna stanja, da se bolesnik liječi lijekom Solymbic.
English: The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience and are displayed by system organ class and frequency in table 3 below: 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); and not known (cannot be estimated from the available data).
Croatian: Sljedeći popis nuspojava temelji se na iskustvu iz kliničkih ispitivanja i nakon stavljanja lijeka u promet, a prikazane su dolje u Tablici 3 prema organskom sustavu i učestalosti: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: What SOLYMBIC looks like and contents of the pack
Croatian: Kako SOLYMBIC izgleda i sadržaj pakiranja
English: If you are over 65 years you may be more susceptible to infections while taking SOLYMBIC.
Croatian: • Ako ste stariji od 65 godina, možete biti podložniji infekcijama za vrijeme primjene lijeka SOLYMBIC.
English: Table 23 Time to treatment failure in studies UV I and UV II
Croatian: Tablica 23 Vrijeme do neuspjeha liječenja u ispitivanjima UV I i UV II
English: The physician educational material should contain:
Croatian: Edukacijski materijali za liječnike trebaju sadržavati:
English: You should continue to inject SOLYMBIC for as long as your doctor has told you.
Croatian: Nastavite injicirati lijek SOLYMBIC onoliko dugo koliko Vam kaže liječnik.
English: SOLYMBIC works by reducing this inflammation.
Croatian: SOLYMBIC djeluje tako da smanjuje tu upalu.
English: SOLYMBIC is a biosimilar medicinal product.
Croatian: SOLYMBIC je biosličan lijek.
English: After proper training in injection technique, patients may self-inject with SOLYMBIC if their physician determines that it is appropriate and with medical follow-up as necessary.
Croatian: Nakon odgovarajuće poduke o tehnici ubrizgavanja injekcija, bolesnici mogu sami sebi davati injekcije lijeka SOLYMBIC ako njihov liječnik procijeni da je to moguće provesti, uz medicinsko praćenje po potrebi.
English: At week 4, subjects were randomised 1:1 based on their body weight at the time to either the low dose or standard dose maintenance regimens as shown in table 19.
Croatian: U četvrtom tjednu su ispitanici randomizirani u omjeru 1:1 na temelju njihove tjelesne težine u tom trenutku za liječenje niskom dozom ili standardnom dozom održavanja, kako je prikazano u Tablici 19.
English: • lupus-like syndrome.
Croatian: • sindrom sličan lupusu.
English: What SOLYMBIC is and what it is used for What you need to know before you use SOLYMBIC How to use SOLYMBIC
Croatian: Što je SOLYMBIC i za što se koristi Što morate znati prije nego počnete primjenjivati lijek SOLYMBIC
English: If you received SOLYMBIC during your pregnancy, your baby may have a higher risk for getting an infection.
Croatian: Ako ste lijek SOLYMBIC primali tijekom trudnoće, Vaše dijete može imati povećan rizik od dobivanja infekcije.
English: Analysis Treatment
Croatian: Analiza Liječenje
English: - Your doctor will also give you a Patient Alert Card, which contains important safety information that you need to be aware of before you are given SOLYMBIC and during treatment with SOLYMBIC.
Croatian: Liječnik će Vam također dati Karticu s upozorenjima za bolesnika koja sadrži važne podatke o sigurnosti s kojima morate biti upoznati prije i za vrijeme liječenja lijekom SOLYMBIC.
English: Clinical remission and clinical response (defined as reduction in PCDAI score of at least 15 points from baseline) rates are presented in table 20.
Croatian: Stope kliničke remisije i kliničkog odgovora (definirano kao smanjenje PCDAI rezultata za barem 15 bodova od početne vrijednosti) prikazane su u Tablici 20.
English: If retreatment with SOLYMBIC is indicated, the above guidance on dose and treatment duration should be followed.
Croatian: Ako je indicirano ponovno liječenje lijekom SOLYMBIC, potrebno je pridržavati se gore navedenih smjernica za doziranje i trajanje liječenja.
English: Advise your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV or if you think you might be at risk of contracting HBV.
Croatian: Obavijestite svog liječnika ako ste nositelj virusa hepatitisa B (HBV), ako imate aktivni HBV ili mislite da biste se mogli zaraziti HBV-om.
English: SOLYMBIC can reduce the number of nodules and abscesses you have, and the pain that is often associated with the disease.
Croatian: SOLYMBIC može smanjiti broj nodula i apscesa koje imate te ublažiti bol koja često prati ovu bolest.
English: How to store SOLYMBIC Contents of the pack and other information
Croatian: Kako čuvati lijek SOLYMBIC Sadržaj pakiranja i druge informacije
English: This inflammation leads to a decrease of vision and/or the presence of floaters in the eye (black dots or wispy lines that move across the field of vision).
Croatian: Ta upala dovodi do slabljenja vida i/ili prisutnosti plutajućih čestica u oku (crnih točkica ili tankih niti koje se kreću vidnim poljem).
English: Contains latex, read the package leaflet before use.
Croatian: Sadrži lateks, prije uporabe pročitajte uputu o lijeku.
English: If you are about to undergo surgery or dental procedures please inform your doctor that you are taking SOLYMBIC.
Croatian: • Ako se spremate podvrgnuti kakvom kirurškom ili stomatološkom zahvatu, molimo da svog liječnika obavijestite o tome da primjenjujete lijek SOLYMBIC.
English: If you accidentally inject SOLYMBIC more frequently than told to by your doctor or pharmacist, you should call your doctor or pharmacist and tell him/her that you have taken more.
Croatian: Ako slučajno primijenite lijek SOLYMBIC češće nego je to preporučio liječnik ili ljekarnik, morate ga nazvati i obavijestiti da ste uzeli veću količinu.
English: Clinical remission Clinical response (CR-100)
Croatian: 4. tjedan Klinička remisija Klinički odgovor (CR-100)
English: If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylaxis treatment before the initiation of SOLYMBIC, and in accordance with local recommendations.
Croatian: Ako se dijagnosticira latentna tuberkuloza, prije početka liječenja lijekom SOLYMBIC mora se započeti odgovarajuća profilaksa tuberkuloze, u skladu s lokalnim preporukama.
English: ● Do not use the pre-filled pen if:
Croatian: Nemojte koristiti napunjenu brizgalicu ako:
English: SOLYMBIC is used to treat Crohn's disease in adults and children aged 6 to 17 years.
Croatian: SOLYMBIC je namijenjen liječenju Crohnove bolesti u odraslih i djece u dobi od 6 do 17 godina.
English: Should treatment be interrupted, SOLYMBIC 40 mg every week may be re-introduced (see section 5.1).
Croatian: Ako liječenje treba privremeno prekinuti, SOLYMBIC se kasnije može ponovno uvesti u dozi od 40 mg svaki tjedan (vidjeti dio 5.1).
English: If an alternate dose is required, other adalimumab products offering such an option should be used.
Croatian: Ako je potrebna druga doza lijeka, potrebno je primijeniti druge lijekove koji sadrže adalimumab, koji imaju takvu mogućnost doziranja.
English: Table 13 Ps study IV efficacy results at 16, 26 and 52 weeks
Croatian: Tablica 13 Ispitivanje Ps IV rezultati djelotvornosti u 16., 26. i 52. tjednu
English: It is important that you tell your baby's doctors and other health care professionals about your SOLYMBIC use during your pregnancy so they can decide when your baby should receive any vaccine.
Croatian: Važno je da liječnika svoga djeteta i druge zdravstvene radnike obavijestite o tome da ste u trudnoći uzimali lijek SOLYMBIC kako bi oni mogli odlučiti kada Vaše dijete treba primiti cjepivo.
English: The conduct and results of these tests should be recorded on your Patient Alert Card.
Croatian: Provođenje i rezultati ovih pretraga moraju se zabilježiti na Vašoj Kartici s upozorenjima za bolesnika.