natgillin/translations-raw huggingface dataset:
Arginine and lysine are rapidly distributed.
Arginin in lizin se hitro porazdelita.
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.
Ni pričakovati interakcij z drugimi zdravili, saj ni informacij o ponovni absorpciji drugih zdravil prek istega mehanizma ponovne absorpcije v ledvicah.
This medicinal product is for single use only.
To zdravilo je namenjeno enkratni uporabi.
You will receive LysaKare in a controlled clinical setting.
Zdravilo LysaKare boste prejeli v nadzorovanem kliničnem okolju.
What LysaKare is and what it is used for 2.
Kaj je zdravilo LysaKare in za kaj ga uporabljamo 2.
The recommended dose of LysaKare solution is 1 L (1,000 mL).
Priporočeni odmerek raztopine zdravila LysaKare je 1 l (1.000 ml).
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: {DD month YYYY}
Datum prve odobritve: {DD. mesec LLLL}
Serum potassium level increases are generally mild and transient.
Povečanja ravni kalija v serumu so na splošno blaga in prehodna.
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.
Bolniku je treba naročiti, naj na dan infundiranja pije večje količine vode (vsaj 1 kozarec vsako uro), da ohrani hidracijo in pospeši izločanje odvečnega kalija iz seruma.
Do not remove unit from overwrap until ready to use.
Enote ne odstranite iz zunanjega ovoja, dokler niste pripravljeni na uporabo.
The main adverse reactions which are related mainly to the amino acid solution are nausea (approximately 25%), vomiting (approximately 10%) and hyperkalaemia.
Glavni neželeni učinki, ki so povezani predvsem z raztopino aminokislin, so navzea (približno 25 %), bruhanje (približno 10 %) in hiperkaliemija.
The toxicities that are observed following administration of PRRT are directly due to radiationabsorbed dose to organs.
Toksični učinki, ki so jih opazili po uporabi PRRT, so neposredna posledica doze sevanja, ki jo absorbirajo organi.
Pharmacotherapeutic group: All other therapeutic products, detoxifying agents for antineoplastic treatment, ATC code: V03AF11
Farmakoterapevtska skupina: Druga nerazvrščena zdravila za različne bolezni, zdravila za zaščito organizma pri zdravljenju neoplazem, oznaka ATC: V03AF11
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.
V primeru pretirane hidracije ali prevelike količine topljenca, je treba spodbuditi izločanje s pogostim uriniranjem ali s forsirano diurezo in pogostim praznjenjem sečnega mehurja.
Do not remove from overwrap until ready for use.
Ne odstranite iz zunanjega ovoja, dokler niste pripravljeni na uporabo.
Do not use if overwrap has been previously opened or damaged.
Ne uporabljajte, če je bil zunanji ovoj predhodno odprt ali poškodovan.
This may indicate that the product is unstable or that the solution has become contaminated.
To je lahko znak nestabilnosti izdelka ali kontaminacije raztopine.
What you need to know before you take LysaKare 3.
Kaj morate vedeti, preden boste uporabili zdravilo LysaKare 3.
The correct storage, use and disposal of this medicine are under the responsibility of the specialist in appropriate premises.
Tega zdravila ne boste shranjevali vi. Za pravilno shranjevanje, uporabo in odstranjevanje tega zdravila je odgovoren specialist v primernih prostorih.
Serum potassium levels must be tested before each treatment with LysaKare.
Ravni kalija v serumu je treba preveriti pred vsakim zdravljenjem z zdravilom LysaKare.
An ECG should be performed prior to discharging the patient.
Po infundiranju je treba pred odpustom bolnika opraviti preiskavo EKG.
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.
Tako kot druge naravno prisotne aminokisline, sta arginin in lizin gradnika pri anabolni presnovi beljakovin ter prekurzorja za več drugih produktov, vključno z dušikovim monoksidom, sečnino, kreatininom in acetil-koencimom A.
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.
Na voljo je zelo malo podatkov o varnostnem profilu raztopine arginina in lizina za infundiranje brez sočasne uporabe PRRT, ki vključuje tudi uporabo antiemetikov kot predhodnega zdravljenja in pogosto tudi sočasno uporabo kratkodelujočih analogov somatostatina.
Arginine and lysine, being naturally occurring amino acids, are excreted in human milk, but effects on the breastfed newborns/infants are unlikely.
Arginin in lizin, ki sta naravno prisotni aminokislini, se izločata v mleko pri človeku, vendar učinki na dojene novorojenčke/dojenčke niso verjetni.
You should receive the full LysaKare dose, regardless of any Lutathera dose adjustments.
Prejeti morate celoten odmerek zdravila LysaKare, ne glede na morebitne prilagoditve odmerka zdravila Lutathera.
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).
Pri bolniku je treba pozorno opazovati znake in simptome hiperkaliemije, npr. dispnejo, šibkost, otrplost, bolečine v prsnem košu in kardiološke manifestacije (motnje prevodnosti in srčne aritmije).
• high potassium levels seen in blood tests, abdominal (belly) pain, headache, dizziness and flushing.
• visoke ravni kalija v krvnih preiskavah, bolečine v abdomnu (trebuhu), glavobol, omotica in vročinski oblivi.
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.
Če ste prejeli večji odmerek zdravila LysaKare, kot bi smeli Zdravilo LysaKare vam bodo dali v nadzorovanem kliničnem okolju, na voljo pa je v vreči z enim odmerkom.
Remaining amino acid is removed by nonrenal clearance.
Preostale aminokisline se odstranijo z neledvičnim očistkom.
This reduction in renal radiation exposure mitigates the risk for radiation-induced renal injury.
To zmanjšanje izpostavitve ledvic sevanju zmanjša tveganje za poškodbe ledvic zaradi sevanja.
Solution for infusion (infusion).
raztopina za infundiranje (infuzija).
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.
Zaradi možnih kliničnih zapletov, povezanih s povečanjem volumna in povečanjem ravni kalija v krvi, povezanega z uporabo zdravila LysaKare, se tega zdravila ne sme uporabljati pri bolnikih s kreatininskim očistkom < 30 ml/min.
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.
Pri uporabi zdravila LysaKare pri bolnikih s hudo jetrno okvaro in v primeru totalne bilirubinemiije (> 3-kratna zgornja normalna vrednost) ali albuminemije (< 30 g/l in razmerje protrombina < 70 % med zdravljenjem) je potrebna previdnost.
For other tests which need to be performed before your treatment, please read the Lutathera leaflet.
Za druge preiskave, ki jih je treba opraviti pred zdravljenjem, preberite navodila za uporabo zdravila Lutathera.
Other medicines and LysaKare Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Infusion bag made of polyvinyl chloride (PVC) containing 1,000 mL of solution, wrapped in a polyethylene polyamine/aluminium foil.
Infuzijska vreča, izdelana iz polivinilklorida (PVC), ki vsebuje 1.000 ml raztopine, zavita v polietilen poliamin/aluminijevo folijo.
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).
Zdravila LysaKare vam ne smejo dati - če ste alergični na arginin in lizin ali katero koli sestavino tega zdravila (navedeno v poglavju 6); če imate povišane vrednosti kalija v krvi (hiperkaliemijo).
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.
Izgled zdravila LysaKare in vsebina pakiranja Zdravilo LysaKare je bistra in brezbarvna raztopina za infundiranje, pakirana v prožno vrečo za enkratno uporabo.
What you need to know before you take LysaKare
Kaj morate vedeti, preden boste uporabili zdravilo LysaKare
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.
Arginin in lizin se v veliki meri izločata in znova absorbirata v ledvicah, od tega pa je odvisna njuna učinkovitost pri zmanjševanju izpostavljenosti ledvic sevanju.
LysaKare should be stored below 25°C.
Zdravilo LysaKare je treba shranjevati pri temperaturi do 25 °C.
The infusion of LysaKare will start 30 minutes before you are given Lutathera, and will last over a 4 hour period.
Infundiranje zdravila LysaKare se bo začelo 30 minut preden vam dajo zdravilo Lutathera in bo trajalo 4 ure.
Liver function (alanine aminotransferase [ALAT], aspartate aminotransferase [ASAT], albumin, bilirubin) should be tested before each administration.
Pred vsako uporabo je treba preveriti delovanje ledvic (ravni alanin-aminotransferaze [ALT], aspartat-aminotransferaze [AST], albumina, bilirubina).
The doctor will also check your kidney and liver function before starting the infusion.
Zdravnik bo prav tako pred začetkom infundiranja preveril delovanje ledvic in jeter.
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.
Klinična učinkovitost in varnost arginina ter lizina temeljita na objavljenih študijah, pri katerih so uporabljali raztopine z enako vsebnostjo arginina in lizina kot v zdravilu LysaKare.
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.
Na podlagi študije, pri kateri so 30 minut infundirali 30 g arginina, izločanje aminokislin iz plazme poteka po vsaj dvofaznem ali trifaznem zmanjšanju, ravni pa se povrnejo na izhodiščne vrednosti v 6 urah po dajanju odmerka.
Care should be taken with LysaKare use in patients with creatinine clearance between 30 and 50 mL/min.
Pri bolnikih s kreatininskim očistkom med 30 in 50 ml/min je potrebna previdnost.
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.
Spodaj navedeni neželeni učinki so bili identificirani v objavah študij z raztopinami aminokislin z enako aminokislinsko sestavo, v katerih je sodelovalo več kot 900 bolnikov, ki so prejeli več kot 2.500 odmerkov arginina in lizina med PRRT z različnimi radioaktivno označenimi analogi somatostatina.
Metabolism and nutrition disorders Hyperkalaemia
Presnovne in prehranske motnje hiperkaliemija
Vital signs should be monitored during the infusion regardless of baseline serum potassium levels.
Med infundiranjem je treba spremljati življenjske znake, ne glede na izhodiščne ravni kalija v serumu.
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.
Na podlagi objave največje študije, pri kateri so uporabili enake količine arginina in lizina kot v zdravilu LysaKare, je bil povprečen odmerek sevanja, ki so ga absorbirale ledvice, določen z dozimetrijo s ploskovnim slikanjem, 20,1 ± 4,9 Gy, kar je nižje od ugotovljenega praga za pojav toksičnih učinkov na ledvicah, 23 Gy.
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.
Spremembe ravnotežja kislin in baz spremenijo ravnotežje zunajceličnega in znotrajceličnega kalija, s hitrimi povečanji koncentracije kalija v plazmi pa je lahko povezan pojav acidoze.
What LysaKare is and what it is used for
Kaj je zdravilo LysaKare in za kaj ga uporabljamo
LysaKare must not be diluted.
Zdravila LysaKare ne smete redčiti.
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.
Zaradi morebitnih kliničnih zapletov, povezanih s povečanjem volumna, je pri uporabi arginina in lizina pri bolnikih s hudim srčnim popuščanjem, opredeljenim kot razred III ali IV po razvrstitvi NYHA, potrebna previdnost.
Driving and using machines It is considered unlikely that LysaKare will affect your ability to drive or to use machines.
Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi zdravilo LysaKare vplivajo na vašo sposobnost upravljanja vozil ali strojev.
The doctor will check your blood potassium levels, and will correct them if they are too high before starting the infusion.
Zdravnik bo pred začetkom infundiranja preveril ravni kalija v krvi in jih popravil, če so povišane.
Due to the intravenous route of administration, LysaKare is 100% bioavailable.
Zdravilo LysaKare je zaradi intravenske poti uporabe 100-% biološko uporabno.
How to store LysaKare 6.
Shranjevanje zdravila LysaKare 6.
01630 Saint Genis Pouilly France
01630 Saint Genis Pouilly Francija
Because elderly patients are more likely to have decreased renal function, care should be taken in determining eligibility based on creatinine clearance.
Pri starejših bolnikih je oslabljeno delovanje ledvic bolj verjetno, zato je pri ocenjevanju primernosti na podlagi kreatininskega očistka potrebna previdnost.
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).
Lu) oksodotreotid zaradi tveganja, povezanega z ionizirajočim sevanjem kontraindiciran pri ugotovljeni nosečnosti ali sumu nanjo, ali kadar nosečnosti ni mogoče izključiti (glejte poglavje 4.1).
LysaKare contains the active substances arginine and lysine, two different amino acids.
Zdravilo LysaKare vsebuje učinkovini arginin in lizin, dve različni aminokislini.
There are no data on the effects of arginine and lysine on fertility.
Podatkov o učinku arginina in lizina na plodnost ni.
Arginine and lysine are naturally occurring amino acids that follow physiological pharmacokinetic steps and biochemical processes after infusion.
Arginin in lizin sta naravno prisotni aminokislini, ki po infundiranju sledita fiziološkim farmakokinetičnim in biokemijskim procesom.
In case hyperkalaemia symptoms develop during LysaKare infusion, appropriate corrective measures must be taken.
Če se med infundiranjem zdravila LysaKare pojavi hiperkaliemija, je treba uporabiti ustrezne korektivne ukrepe.
Pre-treatment with an anti-emetic 30 minutes prior to start of LysaKare infusion is recommended to reduce the incidence of nausea and vomiting.
30 minut pred začetkom infundiranja zdravila LysaKare se priporoča predhodno zdravljenje z antiemetikom za zmanjšanje incidence navzee in bruhanja.
Each infusion bag contains 1 L LysaKare of solution.
Ena vreča za infundiranje vsebuje 1 l raztopine zdravila LysaKare.
There are no data on the use of arginine and lysine in pregnant women.
Podatkov o uporabi arginina in lizina pri nosečnicah ni.
In case of pre-existing clinically significant hyperkalaemia, a second monitoring prior to LysaKare infusion must confirm that hyperkalaemia has been successfully corrected.
Če obstaja klinično pomembna hiperkaliemija, je treba pred infundiranjem zdravila LysaKare ponoviti nadzor, da se potrdi, da je bila hiperkaliemija uspešno odpravljena.
Kidney function (creatinine and creatinine clearance) should be tested before each administration.
Pred vsako uporabo je treba preveriti delovanje ledvic (kreatinin in kreatininski očistek).
The use of arginine and lysine has not been specifically studied in patients with renal impairment.
Uporabe arginina in lizina niso posebej raziskovali pri bolnikih z ledvično okvaro.
oxodotreotide.
Lu) oksodotreotidom.
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.
Po intravenski uporabi so opazili prehodna zvišanja arginina in lizina v plazmi, nato pa se ti zelo vodotopni aminokislini hitro porazdelita po tkivih in telesnih tekočinah.
Metabolic acidosis has been observed with complex amino-acid solutions administered as part of total parenteral nutrition (TPN) protocols.
Pri uporabi kompleksnih raztopin aminokislin kot dela protokolov za popolno parenteralno prehranjevanje (TPN - Total Parenteral Nutrition), so opazili metabolično acidozo.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Polyvinyl chloride (PVC) infusion bag
PODATKI NA STIČNIH OVOJNINAH Vreča za infundiranje iz polivinilklorida (PVC)
1,000 mL
Raztopina za infundiranje 1.000 ml
MARKETING AUTHORISATION HOLDER Advanced Accelerator Applications 20 rue Diesel
Imetnik dovoljenja za promet z zdravilom Advanced Accelerator Applications 20 rue Diesel
What LysaKare contains - The active substances are arginine and lysine.
Kaj vsebuje zdravilo LysaKare - Učinkovini sta arginin in lizin.
LysaKare has no or negligible influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo LysaKare nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Table 1 Adverse drug reactions
Preglednica 1 Neželeni učinki zdravila
Very common (may affect more than 1 in 10 people): • nausea (feeling sick) and vomiting
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov):
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.
Lu) oksodotreotidom se ne priporoča za bolnike s hudim srčnim popuščanjem, opredeljenim kot razred III ali IV po razvrstitvi NYHA, zato je treba pri teh bolnikih vedno pozorno pretehtati koristi in tveganja.
In case of hyperkalaemia, patient's history of hyperkalaemia and concomitant medication should be checked.
Če se pojavi hiperkaliemija, je treba preveriti hiperkaliemijo v bolnikovi anamnezi in zdravila, ki jih jemlje sočasno.
There were no non-clinical studies conducted with LysaKare.
Predkliničnih študij z zdravilom LysaKare niso izvajali.
oxodotreotide and dose limiting if amino acids are not administered to reduce renal uptake and retention.
Lu) oksodotreotida, in so omejujoči dejavnik za odmerek, če se z uporabo aminokislin ne zmanjša ledvični privzem in retencija.
How to take LysaKare
Kako jemati zdravilo LysaKare
LysaKare infusion (see section 4.4).
Lu) oksodotreotidom, zato glejte poglavje 4.4
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Polyethylene polyamine/aluminium foil
Polietilen poliamin/aluminijeva folija
Hyperkalaemia must be corrected accordingly before starting the infusion (see section 4.3).
Skladno s tem je treba pred začetkom infundiranja povrniti kalij na normalno raven (glejte poglavje 4.3).
Water for injections
Pomožna snov: voda za injekcije
Do not use solutions which are cloudy or have deposits.
Ne uporabljajte, če je raztopina motna ali ima oborino.
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 hyperkalaemia in these patients (see section 4.4).
Lu) oksodotreotidom ne priporoča, zato je treba pri teh bolnikih vedno pozorno oceniti razmerje med koristjo in tveganjem, kar mora vključevati upoštevanje povečanega tveganja za prehodno hiperkaliemijo pri teh bolnikih (glejte poglavje 4.4).
Do not use this medicine: - if you notice the solution is cloudy or has deposits.
Ne uporabljajte tega zdravila: - če opazite, da je raztopina motna ali vsebuje oborino; - če je bil zunanji ovoj predhodno odprt ali poškodovan; - če je vreča za infundiranje poškodovana ali pušča.
The use of arginine and lysine has not been studied in patients with severe hepatic impairment.
Uporabe arginina in lizina niso raziskovali pri bolnikih z jetrno okvaro.
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.
Pri infundiranju aminokislin sta siljenje na bruhanje (navzea) in bruhanje pogosta, zato vam bodo 30 minut pred infundiranjem zdravila LysaKare dali zdravila, ki preprečujejo siljenje na bruhanje in bruhanje.
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.
Študija dozimetrije, pri kateri je sodelovali 6 bolnikov, je pokazala, da je 2,5-% raztopina aminoksilin lizina in arginina zmanjšala izpostavitev ledvic sevanju za približno 47 % v primerjavi s skupinami, ki niso prejemale zdravljenja, brez vpliva na privzem lutecijevega (
Nervous system disorders Dizziness
Bolezni živčevja omotica
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.
Farmakokinetičnih podatkov o uporabi arginina in lizina v odmerkih, ki ustrezajo odmerku v zdravilu LysaKare, in za isto indikacijo kot zdravilo LysaKare, pri pediatričnih bolnikih ni. 5.3 Predklinični podatki o varnosti
QUALITATIVE AND QUANTITATIVE COMPOSITION One 1,000 mL bag contains 25 g of L-arginine hydrochloride and 25 g of L-lysine hydrochloride.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena 1.000-ml vreča vsebuje 25 g L-argininijevega klorida in 25 g L-lizinijevega klorida.
• Pre-existing clinically significant hyperkalaemia if not adequately corrected before starting the
• Obstoječa klinično pomembna hiperkaliemija, če ni bila ustrezno popravljena pred začetkom infundiranja zdravila LysaKare (glejte poglavje 4.4).
LysaKare and lutetium (177Lu) oxodotreotide must be given through a separate infusion line.
Lu) oksodotreotid je treba dajati po ločenih infuzijskih linijah.
As you will receive another treatment, Lutathera, with LysaKare, read the Lutathera leaflet carefully as well as this leaflet.
Skupaj z zdravilom LysaKare boste prejeli tudi zdravilo Lutathera, zato pozorno preberite navodilo za uporabo zdravila Lutathera in to navodilo.