FrancophonIA/ELRC3.0 huggingface dataset:
English: What you need to know before you take LysaKare 3.
Danish: Det skal du vide, før du begynder at få LysaKare 3.
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.
Danish: I tilfælde af overhydrering eller overload af opløsningen bør eliminationen fremmes ved hyppig vandladning eller ved forceret diurese og hyppig blæretømning.
English: The toxicities that are observed following administration of PRRT are directly due to radiationabsorbed dose to organs.
Danish: De toksiciteter, der observeres efter administration af PRRT, skyldes absorberede strålingsdoser i organer.
English: - If you have high blood levels of potassium (hyperkalaemia).
Danish: - hvis du har høje niveauer af kalium i blodet (hyperkaliæmi).
English: You should receive the full LysaKare dose, regardless of any Lutathera dose adjustments.
Danish: Du bør få den fulde dosis LysaKare, uanset om der foretages justeringer af dosis af Lutathera.
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.
Danish: Der skal udvises forsigtighed ved anvendelse af LysaKare hos patienter med svær nedsat leverfunktion samt i tilfælde, hvor enten total bilirubinæmi er >3 gange den øvre normale grænse, eller hvor albuminæmi er <30 g/l og protrombin-forholdet er <70 % under behandlingen.
English: The infusion of LysaKare will start 30 minutes before you are given Lutathera, and will last over a 4 hour period.
Danish: Infusionen med LysaKare vil starte 30 minutter før du får Lutathera, og vil foregå over en periode på 4 timer.
English: Arginine and lysine are rapidly distributed.
Danish: Arginin og lysin distribueres hurtigt.
English: You will receive LysaKare in a controlled clinical setting.
Danish: Du vil få LysaKare i kontrollerede kliniske omgivelser.
English: Do not use this medicine: - if you notice the solution is cloudy or has deposits.
Danish: Lægemidlet må ikke anvendes: - Hvis du bemærker, at opløsningen er uklar eller indeholder udfældninger.
English: The patient should be monitored closely for signs and symptoms of hyperkalaemia, e.g. dyspnoea, weakness, numbness, chest pain and cardiac manifestations (conduction abnormalities and cardiac arrhythmias).
Danish: Patienten skal overvåges nøje for tegn og symptomer på hyperkaliæmi, f.eks. dyspnø, svaghed, følelsesløshed, brystsmerter og kardielle manifestationer (impulsledningsforstyrrelser og hjertearytmier).
English: However, in the case of an overdose, you will receive the appropriate treatment.
Danish: Du vil imidlertid modtage passende behandling i tilfælde af, at du får en overdosis.
English: Follow your doctor's advice on how much fluid to drink on the day of your treatment so you stay well hydrated.
Danish: Du skal følge lægens råd om, hvor meget væske du skal drikke på dagen for behandlingen, så du hele tiden får nok væske.
English: Vital signs should be monitored during the infusion regardless of baseline serum potassium levels.
Danish: Vitalparametre skal overvåges under infusionen, uanset status af kaliumniveauerne i serum ved baseline.
English: Serum potassium level increases are generally mild and transient.
Danish: Stigninger i kaliumniveauerne i serum er generelt lette og forbigående.
English: Serum potassium levels must be tested before each treatment with LysaKare.
Danish: Kaliumniveauerne i serum skal måles inden hver behandling med LysaKare.
English: Do not use if overwrap has been previously opened or damaged.
Danish: Må ikke anvendes, hvis yderposen tidligere har været åbnet eller er beskadiget.
English: Do not reconnect partially used bags.
Danish: Delvist brugte poser må ikke tilsluttes igen.
English: The main adverse reactions which are related mainly to the amino acid solution are nausea (approximately 25%), vomiting (approximately 10%) and hyperkalaemia.
Danish: De mest almindelige bivirkninger, der hovedsageligt er relateret til aminosyreopløsningen, er kvalme (ca. 25 %), opkastning (ca. 10 %) og hyperkaliæmi.
English: Metabolic acidosis has been observed with complex amino-acid solutions administered as part of total parenteral nutrition (TPN) protocols.
Danish: Der er observeret metabolisk acidose ved administration af komplekse aminosyreopløsninger som en del af total parenteral ernæring (TPN).
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.
Danish: Der foreligger ingen farmakokinetiske data om brugen af arginin og lysin i samme dosis som LysaKare og til samme indikation hos pædiatriske patienter.
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.
Danish: Ligesom andre naturligt forekommende aminosyrer fungerer arginin og lysin som byggesten under proteinanabolismen og som forstadier for flere andre produkter, herunder nitrogenoxid, urinstof, kreatinin og acetyl-coA.
English: If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.
Danish: Hvis du har yderligere spørgsmål vedrørende brugen af dette lægemiddel, bedes du spørge din læge, apotekspersonalet eller sundhedspersonalet.
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.
Danish: Præmedicinering med et antiemetikum 30 minutter før start af infusion med LysaKare anbefales med henblik på at reducere forekomsten af kvalme og opkastning.
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
Danish: AT, BE, BG, CZ, FR, HR, HU, IS, LU, LV, LT, MT, NL, RO, SI, SK
English: Hyperkalaemia must be corrected accordingly before starting the infusion (see section 4.3).
Danish: Hyperkaliæmi skal korrigeres i overensstemmelse hermed, før infusionen påbegyndes (se pkt.
English: There are very limited data on the safety profile of arginine and lysine solution for infusion without concomitant administration of PRRT, which also includes the use of anti-emetics as pre-medication and often the concomitant use of short acting somatostatin analogues.
Danish: Der foreligger meget begrænsede data om sikkerhedsprofilen af arginin og lysin infusionsvæske, opløsning, uden samtidig administration af PRRT, som også omfatter anvendelsen af antiemetika som præmedicinering og ofte samtidig brug af korttidsvirkende somatostatinanaloger.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1381/001
Danish: EU/1/19/1381/001
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.
Danish: Klinisk virkning og sikkerhed af arginin og lysin er baseret på publiceret litteratur af studier, som anvender opløsninger med det samme arginin- og lysinindhold som LysaKare.
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.
Danish: Baseret på en publikation af det største studie, der anvendte arginin og lysin i samme mængder som LysaKare, var den gennemsnitlige absorberede dosis af nyrerne, som blev bestemt ved hjælp af 2dimensionel billeddannende dosimetri, 20,1 ±4,9 Gy, hvilket er under den fastsatte grænseværdi for forekomsten af nyretoksicitet på 23 Gy.
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.
Danish: Skift i syre/base-balancen ændrer balancen af ekstracellulær og intracellulær kalium, og udviklingen af acidose kan være forbundet med en hurtig øgning af kalium i plasma.
English: LysaKare has no or negligible influence on the ability to drive and use machines.
Danish: LysaKare påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: The overwrap is a moisture barrier.
Danish: Yderposen fungerer som fugtighedsbarriere.
English: Arginine and lysine are naturally occurring amino acids that follow physiological pharmacokinetic steps and biochemical processes after infusion.
Danish: Arginin og lysin er naturligt forekommende aminosyrer, der gennemgår fysiologiske farmakokinetiske trin og biokemiske processer efter infusion.
English: Each infusion bag contains 1 L LysaKare of solution.
Danish: Hver infusionspose indeholder 1 l LysaKare opløsning.
English: There are no data on the effects of arginine and lysine on fertility.
Danish: Der foreligger ingen data vedrørende arginins og lysins virkninger på fertiliteten.
English: Tel Puh/Tlf: +46-8-7205822
Danish: SAM Nordic Tel Puh/Tlf: +46-8-7205822
English: This reduction in renal radiation exposure mitigates the risk for radiation-induced renal injury.
Danish: Denne reduktion i bestråling af nyrerne nedsætter risikoen for strålingsinduceret nyreskade.
English: - if overwrap has been previously opened or damaged.
Danish: - Hvis yderposen tidligere har været åbnet eller er beskadiget.
English: What you need to know before you take LysaKare
Danish: Det skal du vide, før du begynder at få LysaKare
English: Infusion bag made of polyvinyl chloride (PVC) containing 1,000 mL of solution, wrapped in a polyethylene polyamine/aluminium foil.
Danish: Infusionspose fremstillet af polyvinylchlorid (PVC) som indeholder 1.000 ml opløsning og er indpakket i polyethylenpolyamin/aluminiumfolie.
English: • Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Danish: • Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne angivet i pkt.
English: Arginine and lysine, being naturally occurring amino acids, are excreted in human milk, but effects on the breastfed newborns/infants are unlikely.
Danish: Arginin og lysin er naturligt forekommende aminosyrer, der udskilles i modermælk, men virkninger på ammede nyfødte/spædbørn er imidlertid usandsynlig.
English: LysaKare should be stored below 25°C.
Danish: LysaKare skal opbevares ved temperaturer under 25 ºC.
English: How to store LysaKare 6.
Danish: Sådan vil du få LysaKare 4.
English: Care should be taken with LysaKare use in patients with creatinine clearance between 30 and 50 mL/min.
Danish: Der bør udvises forsigtighed med anvendelse af LysaKare hos patienter med kreatininclearance mellem 30 og 50 ml/min.
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.
Danish: Arginin og lysin udskilles i væsentlig grad og reabsorberes af nyrerne, og deres virkning på reduktion af nyrebestrålingseksponering er afhængig af dette.
English: Do not use this medicine after the expiry date which is stated on the label after EXP.
Danish: Anvend ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: • high potassium levels seen in blood tests, abdominal (belly) pain, headache, dizziness and flushing.
Danish: • høje niveauer af kalium set ved blodprøver, mavesmerter (abdominalsmerter), hovedpine,
English: - if the infusion bag is damaged or leaking
Danish: - Hvis infusionsposen er beskadiget eller utæt.
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.
Danish: Der er observeret midlertidige stigninger af arginin og lysin i plasma efter intravenøs administration, hvorefter de stærkt vandopløselige aminosyrer hurtigt fordeles i væv og kropsvæske.
English: Treatment with lutetium (177Lu) oxodotreotide is not recommended in these circumstances.
Danish: Behandling med lutetium (177Lu)-oxodotreotid anbefales ikke under disse omstændigheder.
English: LysaKare contains the active substances arginine and lysine, two different amino acids.
Danish: De aktive stoffer i LysaKare er arginin og lysin, som er to forskellige aminosyrer.
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.
Danish: På grund af muligheden for kliniske komplikationer relateret til volumenoverbelastning og en forøgelse af kalium i blodet i forbindelse med brugen af LysaKare, bør dette produkt ikke gives til patienter med kreatininclearance < 30 ml/min.
English: Because elderly patients are more likely to have decreased renal function, care should be taken in determining eligibility based on creatinine clearance.
Danish: Eftersom der en større sandsynlighed for, at ældre patienter har nedsat nyrefunktion, skal egnetheden vurderes ud fra kreatininclearance.
English: In case hyperkalaemia symptoms develop during LysaKare infusion, appropriate corrective measures must be taken.
Danish: I tilfælde af at der udvikles symptomer på hyperkaliæmi under infusionen med LysaKare, skal der foretages passende korrektioner.
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.
Danish: På grund af muligheden for kliniske komplikationer relateret til volumenoverbelastning bør der udvises forsigtighed ved anvendelse af arginin og lysin hos patienter med alvorligt hjertesvigt, der er defineret som klasse III eller klasse IV i henhold til NYHA-klassificeringen.
English: Driving and using machines It is considered unlikely that LysaKare will affect your ability to drive or to use machines.
Danish: Det anses for usandsynligt, at LysaKare vil påvirke din evne til at føre motorkøretøj eller anvende maskiner.
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.
Danish: Et dosimetristudie med 6 patienter viste, at en 2,5 % aminosyreopløsning med lysin og arginin reducerede bestråling af nyrerne med ca. 47 % sammenlignet med patienter, der ikke modtog behandling, uden at tumoroptagelsen af lutetium (177Lu)-oxodotreotid blev påvirket.
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.
Danish: I tilfælde af alvorlig symptomatisk hyperkaliæmi, skal det overvejes at afbryde infusionen med LysaKare, og det skal overvejes, om fordelene ved nyrebeskyttelse opvejer risiciene ved akut hyperkalæmi.
English: 01630, Saint Genis Pouilly France
Danish: 01630, Saint Genis Pouilly Frankrig
English: Kidney function (creatinine and creatinine clearance) should be tested before each administration.
Danish: Nyrefunktionen (kreatinin og kreatininclearance) bør måles inden hver behandling.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Polyethylene polyamine/aluminium foil
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Polyethylenpolyamin/aluminiumfolie
English: 01630 Saint Genis Pouilly France
Danish: 01630 Saint Genis Pouilly Frankrig
English: In case of hyperkalaemia, patient's history of hyperkalaemia and concomitant medication should be checked.
Danish: I tilfælde af hyperkaliæmi bør patientens anamnese med hensyn til hyperkaliæmi og samtidig medicinering undersøges.
English: There are no data on the use of arginine and lysine in pregnant women.
Danish: Der foreligger ingen data vedrørende anvendelse af arginin og lysin hos gravide kvinder.
English: Do not use solutions which are cloudy or have deposits.
Danish: Opløsninger, som er uklare eller indeholder urenheder, må ikke anvendes.
English: LysaKare and lutetium (177Lu) oxodotreotide must be given through a separate infusion line.
Danish: LysaKare og lutetium (177Lu)-oxodotreotid skal infunderes via adskilte infusionslinjer.
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.
Danish: LysaKare er en klar og farveløs infusionsvæske, opløsning, som leveres i en fleksibel plastpose til engangsbrug.
English: Arginine and lysine undergo glomerular filtration and, via competition, interfere with renal resorption of lutetium (177Lu) oxodotreotide, reducing the radiation dose delivered to the kidney.
Danish: Arginin og lysin undergår glomerulær filtration og interfererer, gennem konkurrence, med renal resorption af lutetium (177Lu)-oxodotreotid, hvorved strålingsdosen, der leveres til nyrerne, reduceres.
English: How to take LysaKare
Danish: Sådan skal du tage LysaKare
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.
Danish: Det anbefalede behandlingsregime hos voksne består af infusion af en hel pose LysaKare samtidig med infusion af lutetium (177Lu)-oxodotreotid, selv når patienten har behov for PRRT-dosisreduktion.
English: In case of pre-existing clinically significant hyperkalaemia, a second monitoring prior to LysaKare infusion must confirm that hyperkalaemia has been successfully corrected.
Danish: I tilfælde af præeksisterende signifikant hyperkaliæmi, skal en yderligere monitorering før LysaKare infusion kunne bekræfte, at hyperkaliæmi er blevet passende korrigeret.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Polyvinyl chloride (PVC) infusion bag
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Infusionspose af polyvinylchlorid (PVC)
English: Do not remove from overwrap until ready for use.
Danish: Fjern ikke yderposen, før produktet skal anvendes.
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.
Danish: LysaKare anvendes hos voksne patienter til at beskytte nyrerne mod unødig stråling under behandling med Lutathera (lutetium (177Lu)-oxodotreotid), som er et radioaktivt lægemiddel, der anvendes til at behandle visse tumorer.
English: The use of arginine and lysine has not been specifically studied in patients with renal impairment.
Danish: Anvendelse af arginin og lysin er ikke blevet undersøgt specifikt hos patienter med nedsat nyrefunktion.
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.
Danish: Kvalme og opkastning er almindelig under infusion med aminosyrer, og derfor vil du få medicin som forebygger kvalme og opkastning 30 minutter før infusionen med LysaKare.
English: If you receive more LysaKare than you should LysaKare will be given in a controlled clinical setting and is provided as a single dose bag.
Danish: LysaKare vil blive givet under kontrollerede kliniske forhold og leveres i en pose med en enkelt dosis.
English: Other medicines and LysaKare Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Danish: Fortæl det altid til lægen, hvis du tager anden medicin eller har gjort det for nylig.
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.
Danish: For at opnå optimal beskyttelse af nyrerne, skal LysaKare administreres som en infusion over 4 timer (250 ml/time), som påbegyndes 30 minutter inden administration af lutetium (177Lu)-oxodotreotid.
English: As you will receive another treatment, Lutathera, with LysaKare, read the Lutathera leaflet carefully as well as this leaflet.
Danish: Eftersom du vil få en anden behandling, Lutathera, sammen med
English: The use of arginine and lysine has not been studied in patients with severe hepatic impairment.
Danish: Anvendelse af arginin og lysin er ikke blevet undersøgt hos patienter med svært nedsat leverfunktion.
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).
Danish: Da lutetium (177Lu)-oxodotreotid, grundet risikoen forbundet med den ioniserende stråling, er kontraindiceret under graviditet, ved mistanke om graviditet samt når graviditet ikke er blevet udelukket, er anvendelse af dette lægemiddel til fertile kvinder ikke relevant (se pkt.
English: LysaKare is indicated for reduction of renal radiation exposure during peptide-receptor radionuclide therapy (PRRT) with lutetium (177Lu) oxodotreotide in adults.
Danish: LysaKare er indiceret til reduktion af bestrålingaf nyrerne under peptidreceptor-radionuklid-terapi (PRRT) med lutetium (177Lu)-oxodotreotid hos voksne.
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).
Danish: - hvis du er allergisk over for arginin og lysin eller et af de øvrige indholdsstoffer i LysaKare
English: Due to the intravenous route of administration, LysaKare is 100% bioavailable.
Danish: LysaKares biotilgængelighed er 100 %, hvilket skydes den intravenøse administrationsvej.
English: What LysaKare contains - The active substances are arginine and lysine.
Danish: - Aktive stoffer: arginin og lysin.
English: Based on a study with 30 g arginine infused over 30 minutes, plasma elimination of amino acids follows at least a biphasic or triphasic decline, with levels returning to baseline within 6 hours post-dose.
Danish: Eliminationen fra plasma er som minimum bifasisk eller trifasisk, og niveauerne vender tilbage til baseline inden for 6 timer efter indgivet dosis.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for infusion
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE)
English: Breast-feeding should be avoided during treatment with lutetium (177Lu) oxodotreotide.
Danish: Amning bør undgås under behandling med lutetium (177Lu)-oxodotreotid.
English: • Pre-existing clinically significant hyperkalaemia if not adequately corrected before starting the
Danish: • Præeksisterende klinisk signifikant hyperkaliæmi som ikke er tilstrækkeligt afhjulpet, inden påbegyndelse af infusion med LysaKare (se pkt.
English: Treatment with lutetium (177Lu) oxodotreotide is not recommended for patients with severe heart failure defined as class III or class IV in the NYHA classification therefore, the benefit risk for these patients will always need to be weighed carefully.
Danish: Behandling med lutetium (177Lu)-oxodotreotid anbefales ikke til patienter med alvorligt hjertesvigt, der er defineret som klasse III eller klasse IV i henhold til NYHA-klassificeringen.
English: Treatment with lutetium (177Lu) oxodotreotide is not recommended for patients with renal function between 30 and 50 mL/min therefore, the benefit risk for these patients will always need to be weighed carefully, which should include consideration of an increased risk for transient hyperkalemia in these patients.
Danish: Behandling med lutetium (177Lu) oxodotreotid anbefales ikke hos patienter med en nyrefunktion på mellem 30 og 50 ml/ml, og derfor skal fordelene ved behandlingen for disse patienter altid bedømmes i forhold til risikoen.
English: Metabolism and nutrition disorders Hyperkalaemia
Danish: Metabolisme og ernæring