FrancophonIA/ELRC3.0 huggingface dataset:
English: DK, EE, FI, NO, SE SAM Nordic
Croatian: DK, EE, FI, NO, SE
English: LysaKare is given as an infusion (drip) into a vein.
Croatian: LysaKare se daje kao infuzija (drip) u venu.
English: No interaction with other medicinal product is expected since there is no information that other drugs are re-absorbed by the same kidney re-absorption mechanism.
Croatian: Ne očekuje se interakcija s drugima lijekovima jer nema informacija da se drugi lijekovi reapsorbiraju istim mehanizmom reapsorpcije u bubregu.
English: Do not use if overwrap has been previously opened or damaged.
Croatian: Nemojte koristiti ako jezaštitni omot prethodno otvaran ili oštećen.
English: It belongs to a group of medicines which are used to reduce the side effects of anti-cancer medicine.
Croatian: Pripada skupini lijekova koji se koriste za smanjivanje nuspojava lijekova protiv raka.
English: Hyperkalaemia must be corrected accordingly before starting the infusion (see section 4.3).
Croatian: Hiperkalijemija se mora odgovarajuće korigirati prije početka infuzije (vidjeti dio 4.3).
English: What you need to know before you take LysaKare
Croatian: Što morate znati prije nego primite LysaKare
English: This medicinal product is for single use only.
Croatian: Ovaj lijek je samo za jednokratnu primjenu.
English: LysaKare must not be diluted.
Croatian: LysaKare se ne smije razrijeđivati.
English: - If you have high blood levels of potassium (hyperkalaemia).
Croatian: - ako imate visoke razine kalija u krvi (hiperkalijemija).
English: For other tests which need to be performed before your treatment, please read the Lutathera leaflet.
Croatian: Za druge testove koje treba provesti prije Vašeg liječenja, pročitajte uputu o lijeku Lutathera.
English: You will receive LysaKare in a controlled clinical setting.
Croatian: Lijek LysaKare primit ćete u kontroliranom kliničkom okruženju.
English: Patients should be instructed to drink substantial quantities of water (at least 1 glass every hour) on the day of infusion to remain hydrated and facilitate excretion of excess serum potassium.
Croatian: Bolesnike treba uputiti da piju dostatne količine vode (barem jednu čašu svaki sat) na dan infuzije kako bi ostali hidrirani te kako bi se olakšalo izlučivanje viška serumskog kalija.
English: Pharmacotherapeutic group: All other therapeutic products, detoxifying agents for antineoplastic treatment, ATC code: V03AF11
Croatian: Farmakoterapijska skupina: Ostali terapijski pripravci, detoksificirajuća sredstva kod citostatske terapije, ATK oznaka: V03AF11
English: Do not use this medicine after the expiry date which is stated on the label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici iza oznake „EXP”.
English: What LysaKare is and what it is used for 2.
Croatian: Što je LysaKare i za što se koristi 2.
English: Other medicines and LysaKare Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Initial rapid clearance is through glomerular filtration in the kidney in the first 90 minutes post-infusion.
Croatian: Početni rapidni klirens odvija se glomerularnom filtracijom u bubregu u prvih 90 minuta nakon infuzije.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1381/001
Croatian: EU/1/19/1381/001
English: Talk to your doctor before taking LysaKare if your kidneys, heart or liver are severely impaired or if you have a history of high blood levels of potassium (hyperkalaemia).
Croatian: Obratite se svom liječniku prije nego primite LysaKare ako su Vaši bubrezi, srce ili jetra jako oštećeni ili u povijesti bolesti imate anamnezu visokih razina kalija u krvi (hiperkalijemija)
English: If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku, medicinskoj sestri ili ljekarniku.
English: Arginine and lysine are rapidly distributed.
Croatian: Eliminacija Arginin i lizin distribuiraju se brzo.
English: The doctor will check your blood potassium levels, and will correct them if they are too high before starting the infusion.
Croatian: Liječnik će provjeriti Vaše razine kalija u krvi i ako su previsoke ispravit će ih prije početka infuzije.
English: AT, BE, BG, CZ, FR, HR, HU, IS, LU, LV, LT, MT, NL, RO, SI, SK Advanced Accelerator Applications Tel/Tél/ Teл/Sími: + 33 4 50 99 30 70
Croatian: AT, BE, BG, CZ, FR, HR, HU, IS, LU, LV, LT, MT, NL, RO, SI, SK
English: Serum potassium level increases are generally mild and transient.
Croatian: Porast razine serumskog kalija općenito je blag i prolazan.
English: You should not be given LysaKare - if you are allergic to arginine and lysine or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na arginin i lizin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: The recommended dose of LysaKare solution is 1 L (1,000 mL).
Croatian: Preporučena doza lijeka LysaKare je 1 litar (1000 ml).
English: Laboratoire Bioluz Zone Industrielle de Jalday 64500 Saint Jean de Luz France
Croatian: Laboratoire Bioluz Zone Industrielle de Jalday 64500 Saint Jean de Luz Francuska
English: Like other naturally occurring amino acids, arginine and lysine serve as building blocks in protein anabolism and serve as precursors for several other products, including nitric oxide, urea, creatinine, and Acetyl-Coenzyme A.
Croatian: Poput drugih aminokiselina koje se normalno javljaju u prirodi, arginin i lizin služe kao građevne jedinice u anabolizmu proteina te služe kao prekursori za nekoliko drugih produkata, uključujući dušikov oksid, ureu, kreatinin i acetil-koenzim A.
English: The main adverse reactions which are related mainly to the amino acid solution are nausea (approximately 25%), vomiting (approximately 10%) and hyperkalaemia.
Croatian: Glavne nuspojave koje su povezane uglavnom s otopinom aminokiselina su mučnina (približno 25%), povraćanje (približno 10%) te hiperkalijemija.
English: Do not remove from overwrap until ready for use.
Croatian: Nemojte vaditi iz zaštitnog omota dok sve nije spremno za primjenu.
English: This reduction in renal radiation exposure mitigates the risk for radiation-induced renal injury.
Croatian: Ovo smanjenje izloženosti bubrega zračenju smanjuje rizik od ozljede bubrega izazvane zračenjem.
English: These adverse reactions are mostly mild to moderate.
Croatian: Te nuspojave uglavnom su blage do umjerene.
English: Kidney function (creatinine and creatinine clearance) should be tested before each administration.
Croatian: Funkciju bubrega (kreatinin i klirens kreatinina) treba provjeriti prije svake primjene.
English: The overwrap is a moisture barrier.
Croatian: Omot je barijera za vlagu.
English: Care should be taken with LysaKare use in patients with severe hepatic impairment and in case of either total bilirubinemia >3 times the upper limit of normal or albuminemia <30 g/L and prothrombin ratio <70% during treatment.
Croatian: Potreban je oprez kod primjene lijeka LysaKare u bolesnika s teškim oštećenjem jetre te u slučaju ukupne bilirubinemije >3 puta od gornje granice normale ili albuminemije <30 g/l te protrombinskog omjera <70% tijekom liječenja.
English: You should receive the full LysaKare dose, regardless of any Lutathera dose adjustments.
Croatian: Morate primiti punu dozu lijeka LysaKare, neovisno o prilagodbama doze lijeka Lutathera.
English: Tel Puh/Tlf: +46-8-7205822
Croatian: SAM Nordic Tel Puh/Tlf: +46-8-7205822
English: LysaKare contains the active substances arginine and lysine, two different amino acids.
Croatian: LysaKare sadrži djelatne tvari arginin i lizin, dvije različite aminokiseline.
English: LysaKare has no or negligible influence on the ability to drive and use machines.
Croatian: LysaKare ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Infusion bag made of polyvinyl chloride (PVC) containing 1,000 mL of solution, wrapped in a polyethylene polyamine/aluminium foil.
Croatian: Infuzijska vrećica od polivinilklorida (PVC) koja sadrži 1000 ml otopine, omotana u zaštitnu foliju od polietilen poliamina/aluminija.
English: Metabolic acidosis has been observed with complex amino-acid solutions administered as part of total parenteral nutrition (TPN) protocols.
Croatian: Metabolička acidoza uočena je kod primjene otopina s kompleksima aminokiselina kao dio protokola ukupne parenteralne prehrane (engl. total parenteral nutrition, TPN).
English: Due to the intravenous route of administration, LysaKare is 100% bioavailable.
Croatian: Zbog intravenskog načina primjene, bioraspoloživost lijeka LysaKare je 100%.
English: As you will receive another treatment, Lutathera, with LysaKare, read the Lutathera leaflet carefully as well as this leaflet.
Croatian: S obzirom da ćete s lijekom LysaKare primati i drugu terapiju, lijek Lutathera, pažljivo pročitajte uputu o lijeku Lutathera kao i ovu uputu.
English: Clinical efficacy and safety for arginine and lysine are based on published literature of studies using solutions with the same arginine and lysine content as LysaKare.
Croatian: Klinička djelotvornosti sigurnost arginina i lizina temelje se na objavljenoj literaturi ispitivanja primjene otopina s istim sadržajem arginina i lizina kao i LysaKare.
English: The toxicities that are observed following administration of PRRT are directly due to radiationabsorbed dose to organs.
Croatian: Toksičnosti uočene nakon primjene PRRT-a izravno su povezane s dozom zračenja koju su apsorbirali organi.
English: The infusion of LysaKare will start 30 minutes before you are given Lutathera, and will last over a 4 hour period.
Croatian: Infuzija lijeka LysaKare počet će 30 minuta prije primjene lijek Lutathera te će trajati tijekom 4 sata.
English: There are no data on the effects of arginine and lysine on fertility.
Croatian: Nema podataka o učincima arginina i lizina na plodnost.
English: The doctor will also check your kidney and liver function before starting the infusion.
Croatian: Liječnik će prije početka infuzije također provjeriti funkciju Vaših bubrega i jetre.
English: Arginine and lysine are substantially excreted and reabsorbed by the kidney, and their efficacy in the reduction of renal radiation exposure is dependent on this.
Croatian: Arginin i lizin se u značajnoj mjeri izlučuju i reapsorbiraju bubrezima te njihova djelotvornost u smanjenju izlaganja bubrega zračenju ovisi o tome.
English: Treatment with lutetium (177Lu) oxodotreotide is not recommended in these circumstances.
Croatian: Liječenje lutecijevim (177Lu) oksodotreotidom ne preporučuje se u tim okolnostima.
English: There is no relevant use of this medicinal product in women of childbearing potential since lutetium (177Lu) oxodotreotide is contraindicated during established or suspected pregnancy or when pregnancy has not been excluded due to the risk associated with the ionizing radiation (see section 4.1).
Croatian: Nema relevantne primjene ovog lijeka u žena reproduktivne dobi jer je zbog rizika povezanih s ionizirajućim zračenjem lutecijevog (177Lu) oksodotreotida kontraindiciran tijekom potvrđene ili suspektne trudnoće ili kada trudnoća nije isključena (vidjeti dio 4.1).
English: There are no data on the use of arginine and lysine in pregnant women.
Croatian: Nema podataka o uporabi arginina i lizina u trudnica.
English: Serum potassium levels must be tested before each treatment with LysaKare.
Croatian: Razine serumskog kalija treba provjeriti prije svake terapije lijekom LysaKare.
English: Shifts in acid-base balance alter the balance of extracellularintracellular potassium and the development of acidosis may be associated with rapid increases in plasma potassium.
Croatian: Promjene u acidobaznoj ravnoteži mijenjaju ravnotežu vanstaničnog-unutarstaničnog kalija te se razvoj acidoze može povezati s brzim porastom u razinama plazmatskog kalija.
English: Based on a publication of the largest study using arginine and lysine in the same quantities as LysaKare, the average kidney absorbed dose, as determined by planar imaging dosimetry, was 20.1±4.9 Gy, which is below the established threshold for the occurrence of renal toxicities of 23 Gy.
Croatian: Na temelju publikacije najvećeg ispitivanja u kojem su primjenjivani arginin i lizin u istim količinama kao i kod lijeka LysaKare, prosječna doza koju apsorbira bubreg, određena planarnim dozimetrijskim oslikavanjem, iznosila je od 20,1±4,9 Gy, što je ispod utvrđenog praga za pojavu bubrežne toksičnosti od 23 Gy.
English: Pre-treatment with an anti-emetic 30 minutes prior to start of LysaKare infusion is recommended to reduce the incidence of nausea and vomiting.
Croatian: Preporučuje se predliječenje antiemetikom 30 minuta prije početka infuzije lijeka LysaKare kako bi se smanjila incidencija mučnine i povraćanja.
English: Due to potential for clinical complications related to volume overload care should be taken with use of arginine and lysine in patients with severe heart failure defined as class III or class IV in the NYHA classification.
Croatian: Zbog potencijala za kliničke komplikacije povezane s volumnim opterećenjem potrebno je biti oprezan kod uporabe argininina i lizina u bolesnika s teškim zatajenjem srca definiranim kao klasa III ili IV prema NYHA klasifikaciji.
English: Do not use solutions which are cloudy or have deposits.
Croatian: Nemojte upotrebljavati otopine koje su zamućene ili imaju taloge.
English: In case of severe symptomatic hyperkalaemia, discontinuation of LysaKare infusion should be considered, taking into consideration the risk-benefit of renal protection versus acute hyperkalaemia.
Croatian: U slučaju teške simptomatske hiperkalijemije, potrebno je razmotriti prekid primjene infuzije lijeka LysaKare, uzimajući u obzir omjer koristi i rizika zaštite bubrega naspram akutne hiperkalijemije.
English: LysaKare should be administered as a 4-hour infusion (250 mL/hour) starting 30 minutes prior to administration of lutetium (177Lu) oxodotreotide to achieve optimal renal protection.
Croatian: LysaKare treba primjenjivati u obliku 4-satne infuzije (250 ml/sat) s početkom 30 minuta prije primjene lutecijevog oksodotreotida (177Lu) kako bi se postigla optimalna zaštita bubrega.
English: Liver function (alanine aminotransferase [ALAT], aspartate aminotransferase [ASAT], albumin, bilirubin) should be tested before each administration.
Croatian: Prije svake primjene potrebno je provjeriti funkciju jetre (alanin aminotransferaza [ALT], aspartat aminotransferaza [AST], albumin, bilirubin).
English: 1,000 mL
Croatian: Otopina za infuziju 1000 ml
English: Remaining amino acid is removed by nonrenal clearance.
Croatian: Preostala aminokiselina uklanja se nerenalnim klirensom.
English: Arginine and lysine are naturally occurring amino acids that follow physiological pharmacokinetic steps and biochemical processes after infusion.
Croatian: Arginin i lizin su kiseline koje se normalno javljaju u prirodi, a koje slijede fiziološke farmakokinetičke korake i biokemijske procese nakon infuzije.
English: The adverse reactions listed below have been identified in publications of studies with amino acid solutions with the same composition with regards to the amino acid content, involving over 900 patients receiving more than 2,500 doses of arginine and lysine during PRRT with various radiolabelled somatostatin analogues.
Croatian: Nuspojave navedene u nastavku identificirane su u publikacijama ispitivanja s otopinama aminokiselina istog sastava s obzirom na sadržaj aminokiselina, uključujući preko 900 bolesnika koji su primali više od 2500 doza arginina i lizina tijekom PRRT-a s različitim radioaktivno označenim analozima somatostatina.
English: • high potassium levels seen in blood tests, abdominal (belly) pain, headache, dizziness and flushing.
Croatian: • visoke razine kalija otkrivene u krvnim pretragama, bol u trbuhu, glavobolja, omaglica i navala crvenila.
English: LysaKare should be stored below 25°C.
Croatian: Lijek LysaKare treba čuvati na temperaturi ispod 25 °C.
English: Because feeling sick (nausea) and vomiting are commonly seen with amino acid infusions, you will be given medicines to prevent nausea and vomitting 30 minutes before the LysaKare infusion.
Croatian: S obzirom da se mučnina i povraćanje obično uočavaju kod infuzija aminokiselina, dobit ćete lijekove za prevenciju mučnine i povraćanja 30 minuta prije infuzije lijeka LysaKare.
English: A dosimetry study including 6 patients showed that a 2.5% Lysine-Arginine amino acid solution reduced renal radiation exposure by about 47% as compared to no treatment, without having an effect on tumour uptake of lutetium (177Lu) oxodotreotide.
Croatian: Ispitivanje dozimetrije koje je uključivalo 6 bolesnika pokazalo je da je 2,5%-tna otopina aminokiselina lizina/arginina smanjila izlaganje bubrega zračenju za otprilike 47% u usporedbi s kontrolama bez terapije, bez učinka na unos lutecijevog (177Lu) oksodotreotida u tkivu tumora.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Polyethylene polyamine/aluminium foil
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Polietilen poliamin/aluminijska folija
English: What LysaKare looks like and contents of the pack LysaKare is a clear and colourless solution for infusion, supplied in a single use flexible plastic bag.
Croatian: LysaKare je bistra i bezbojna otopina za infuziju koja se isporučuju u fleksibilnoj plastičnoj vrećici za jednokratnu uporabu.
English: LIST OF EXCIPIENTS Excipient: water for injections
Croatian: POPIS POMOĆNIH TVARI Pomoćna tvar: voda za injekcije
English: Because elderly patients are more likely to have decreased renal function, care should be taken in determining eligibility based on creatinine clearance.
Croatian: S obzirom da je u starijih osoba veća vjerojatnost smanjene bubrežne funkcije, potreban je oprez u određivanju prikladnosti bolesnika za terapiju, na temelju klirensa kreatinina.
English: SPECIAL STORAGE CONDITIONS Store below 25°C.
Croatian: POSEBNE MJERE ČUVANJA Čuvati na temperaturi ispod 25°C.
English: Care should be taken with LysaKare use in patients with creatinine clearance between 30 and 50 mL/min.
Croatian: Potreban je oprez kod primjene lijeka LysaKare u bolesnika s klirensom kreatinina između 30 i 50 ml/min.
English: 4.4 Special warnings and precautions for use
Croatian: 4.4 Posebna upozorenja i mjere opreza
English: - if the infusion bag is damaged or leaking
Croatian: - ako je zaštitni omot prethodno otvaran ili oštećen - ako je infuzijska vrećica oštećena ili propušta
English: LysaKare and lutetium (177Lu) oxodotreotide must be given through a separate infusion line.
Croatian: LysaKare i lutecijev (177Lu) oksodotreotid moraju se davati kroz zasebne infuzijske linije.
English: Due to the potential for clinical complications related to volume overload and an increase of potassium in blood associated with the use of LysaKare, this product should not be administered in patients with creatinine clearance <30 mL/min.
Croatian: Zbog potencijala za kliničke komplikacije povezane s volumnim opterećenjem te porastom koncentracije kalija u krvi povezane s uporabom lijeka LysaKare, ovaj lijek ne smije se primjenjivati u bolesnika s klirensom kreatinina <30 ml/min.
English: In the event of over-hydration or solute overload, the elimination should be promoted by frequent micturition or by forced diuresis and frequent bladder voiding.
Croatian: U slučaju prekomjerne hidracije ili preopterećenja otopinom, eliminaciju treba poticati čestim mokrenjem ili forsiranom diurezom te čestim pražnjenjem mjehura.
English: Vital signs should be monitored during the infusion regardless of baseline serum potassium levels.
Croatian: Vitalne znakove treba nadzirati tijekom infuzije neovisno o početnim razinama serumskog kalija.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati LysaKare Lijek čuvajte izvan pogleda i dohvata djece.
English: How to take LysaKare
Croatian: Kako primjenjivati LysaKare
English: As LysaKare is administered with lutetium (177Lu) oxodotreotide, please also refer to section 4.4 of the lutetium (177Lu) oxodotreotide SmPC for further warnings specific to treatment with lutetium (177Lu)
Croatian: S obzirom da se LysaKare primjenjuje s lutecijevim (177Lu) oksodotreotidom potrebno je pogledati također dio 4.4 sažetka opisa svojstva lijeka lutecijevog (177Lu) oksodotreotida za daljnja upozorenja specifična za terapiju lutecijevim (177Lu) oksodotreotidom.
English: Transient elevations in plasma arginine and lysine are observed after intravenous administration, whereupon the highly water soluble amino acids are quickly distributed throughout tissues and body fluid.
Croatian: Prolazna povišenja arginina i lizina u plazmi uočena su nakon intravenske primjene, pri čemu se u vodi visokotopljive aminokiseline brzo distribuiraju u tkiva i tjelesne tekućine.
English: There were no non-clinical studies conducted with LysaKare.
Croatian: 5.3 Neklinički podaci o sigurnosti Nisu provedena neklinička ispitivanja lijeka Lysakare.
English: No pharmacokinetic data are available on the use of arginine and lysine at the same dose as LysaKare and for the same indication in paediatric patients.
Croatian: Nema dostupnih farmakokinetičkih podataka u pedijatrijskih bolesnika vezano za primjenu arginina i lizina u istoj dozi kao kod lijeka LysaKare te za istu indikaciju.
English: An increase of serum potassium levels may occur in patients receiving arginine and lysine.
Croatian: Hiperkalijemija Povišene razine kalija u serumu mogu se pojaviti u bolesnika koji primaju arginin i lizin.
English: Arginine and lysine, being naturally occurring amino acids, are excreted in human milk, but effects on the breastfed newborns/infants are unlikely.
Croatian: Dojenje S obzirom da su aminokiseline koje se normalno javljaju u prirodi, arginin i lizin se izlučuju u majčinom mlijeku, a učinci na dojenu novorođenčad/dojenčad nisu vjerojatni.
English: Clear, colourless solution, free from visible particles pH: 5.1 - 6.1
Croatian: Bistra, bezbojna otopina, bez vidljivih čestica pH: 5,1 - 6,1 Osmolarnost: 420 - 480 mOsm/L
English: LysaKare is used in adult patients to protect kidneys from unnecessary radiation during treatment with Lutathera (lutetium (177Lu) oxodotreotide), a radioactive medicine used to treat certain tumours.
Croatian: LysaKare se koristi u odraslih bolesnika za zaštitu bubrega od nepotrebnog zračenja tijekom liječenja lijekom Lutathera (lutecijevim (177Lu) oksodotreotidom), radioaktivnim lijekom koji se koristi za liječenje određenih tumora.
English: What LysaKare is and what it is used for
Croatian: Što je LysaKare i za što se koristi Što je LysaKare
English: What LysaKare is used for
Croatian: Za što se LysaKare koristi
English: The recommended treatment regimen in adults consists of infusion of full bag of LysaKare concomitantly with lutetium (177Lu) oxodotreotide infusion, even when patients require PRRT dose reduction.
Croatian: Preporučeni terapijski režim u odraslih bolesnika sastoji se od infuzije cjelokupnog sadržaja vrećice lijeka LysaKare istodobno s infuzijom lutecijevog (177Lu) oksodotreotida čak i kada je u bolesnika potrebno smanjenje doze PRRT-a.
English: In case of hyperkalaemia, patient's history of hyperkalaemia and concomitant medication should be checked.
Croatian: U slučaju hiperkalijemije, potrebno je provjeriti bolesnikovu anamnezu hiperkalijemije i istodobno primjenjivane lijekove.
English: In case of pre-existing clinically significant hyperkalaemia, a second monitoring prior to LysaKare infusion must confirm that hyperkalaemia has been successfully corrected.
Croatian: U slučaju prethodno postojeće klinički značajne hiperkalijemije potrebno je ponovno praćenje kako bi se potvrdilo da je hiperkalijemija uspješno korigirana prije početka infuzije lijeka LysaKare.