FrancophonIA/ELRC3.0 huggingface dataset:
English: - if your resting heart rate before treatment is too slow (below 70 beats per minute); - if you are suffering from cardiogenic shock (a heart condition treated in hospital); - if you suffer from a heart rhythm disorder; - if you are having a heart attack; - if you suffer from very low blood pressure; - if you suffer from unstable angina (a severe form in which chest pain occurs very frequently and with or without exertion); - if you have heart failure which has recently become worse; - if your heartbeat is exclusively imposed by your pacemaker; - if you suffer from severe liver problems; - if you are already taking medicines for the treatment of fungal infections (such as ketoconazole,
Slovenian: Ne jemljite zdravila Ivabradine Accord če ste alergični na ivabradin ali katero koli sestavino tega zdravila (navedeno v poglavju 6); če je vaša srčna frekvenca med mirovanjem pred zdravljenjem prepočasna (manj kot 70 utripov na minuto); če imate kardiogeni šok (bolezen srca, ki zahteva zdravljenje v bolnišnici); če imate motnje srčnega ritma; če imate miokardni infarkt; če imate zelo nizek krvni tlak; če imate nestabilno angino pektoris (hudo obliko, pri kateri se bolečine v prsih pojavljajo zelo pogosto, med naporom ali brez njega); če imate srčno popuščanje, ki se je pred kratkim poslabšalo; če vam srčni utrip narekuje izključno vaš srčni spodbujevalnik; če imate hude težave z jetri; če že jemljete zdravila za zdravljenje glivičnih okužb (na primer ketokonazol, itrakonazol), makrolidne antibiotike (na primer josamicin, klaritromicin, telitromicin ali eritromicin peroralno), zdravila za zdravljenje okužb z virusom HIV (na primer nelfinavir, ritonavir) ali nefazodon (zdravilo za zdravljenje depresije) ali diltiazem, verapamil (uporabljata se za zniževanje krvnega tlaka ali zdravljenje angine pektoris); če ste ženska v rodni dobi in ne uporabljate zanesljive kontracepcije; če ste noseči ali želite zanositi; če dojite.
English: 98x1 film-coated tablets
Slovenian: 98 x 1 filmsko obložena tableta
English: INSTRUCTIONS ON USE 16.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE 10.
English: interval)
Slovenian: Accord
English: Combination with strong cytochrome P450 3A4 inhibitors such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone (see sections 4.5 and 5.2)
Slovenian: 4.3 Kontraindikacije preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 srčna frekvenca med mirovanjem pod 70 utripov na minuto pred zdravljenjem kardiogeni šok akutni miokardni infarkt huda hipotenzija (< 90/50 mm Hg) hudo jetrno popuščanje sindrom bolnega sinusnega vozla sinoatrijski blok nestabilno ali akutno srčno popuščanje odvisnost od srčnega spodbujevalnika (srčna frekvenca, ki jo narekuje izključno srčni spodbujevalnik) nestabilna angina pektoris atrioventrikularni blok 3. stopnje kombinacija z močnimi zaviralci CYP3A4, kot so azolski antimikotiki (ketokonazol, itrakonazol), makrolidni antibiotiki (klaritromicin, eritromicin peroralno, josamicin, telitromicin), zaviralci proteaze virusa HIV (nelfinavir, ritonavir) in nefazodon (glejte poglavji 4.5 in 5.2) kombinacija z verapamilom ali diltiazemom, zmernima zaviralcema CYP3A4, ki imata lastnosti zniževanja srčne frekvence (glejte poglavje 4.5) nosečnost, dojenje in ženske v rodni dobi, ki ne uporabljajo zanesljivih kontracepcijskih metod (glejte poglavje 4.6)
English: Unstable or acute heart failure
Slovenian: Neenakomeren srčni utrip.
English: General disorders and administration site conditions
Slovenian: Splošne težave in spremembe na mestu aplikacije občasni*
English: Not known (frequency cannot be estimated from the available data):
Slovenian: Neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov):
English: Once the container has been opened, the contents should be used immediately.
Slovenian: Ko je vsebnik odprt, je treba vsebino porabiti takoj.
English: This medicine should not be given to children and adolescents under 18 years old because it is not known whether it is safe and effective in this age group.
Slovenian: Tega zdravila se ne sme dajati otrokom in mladostnikom, mlajšim od 18 let, ker ni znano, ali je pri tej starostni skupini varno in učinkovito.
English: Follow all of your doctor's instructions carefully.
Slovenian: Dosledno upoštevajte vsa zdravnikova navodila.
English: The frequencies are categorised as follows: 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), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Slovenian: Pogostnosti neželenih učinkov so razvrščene na naslednji način: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (<1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Do not reconnect partially used bags.
Slovenian: Delno uporabljenih vreč ne priključite ponovno.
English: The following information is intended for the healthcare specialist charged with your care.
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju, ki bo zadolženo za vašo oskrbo.
English: The safety and efficacy of LysaKare in children less than 18 years have not been established.
Slovenian: Varnost in učinkovitost zdravila LysaKare pri otrocih, mlajših od 18 let, nista bili dokazani.
English: These adverse reactions are mostly mild to moderate.
Slovenian: Ti neželeni učinki so večinoma blagi do zmerni.
English: It belongs to a group of medicines which are used to reduce the side effects of anti-cancer medicine.
Slovenian: Spada v skupino zdravil, ki se uporabljajo za zmanjševanje neželenih učinkov zdravil proti raku.
English: Osmolarity: 420 - 480 mOsm/L
Slovenian: Osmolarnost: 420-480 mOsm/l
English: The adverse reactions are listed according to the frequency.
Slovenian: Neželeni učinki so navedeni glede na pogostnost.
English: It is therefore unlikely that you will receive more of the infusion than you should as your doctor will monitor you during the treatment.
Slovenian: Zato ni verjetno, da bi vam infundirali večjo količino, kot bi smeli, saj vas bo med zdravljenjem spremljal zdravnik.
English: However, in the case of an overdose, you will receive the appropriate treatment.
Slovenian: V morebitnem primeru prevelikega odmerjanja boste prejeli ustrezno zdravljenje.
English: According to limited available data maximum levels should be reached approximatively by 4 to 5 hours after start of the infusion and should return to normal levels by 24 hours.
Slovenian: Omejeni razpoložljivi podatki kažejo, da naj bi najvišjo raven dosegle v približno 4 do 5 urah po začetku infundiranja, na normalne vrednosti pa naj bi se vrnile v 24 urah.
English: Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Slovenian: Študije pri živalih niso zadostne za ugotavljanje toksičnega vpliva na sposobnost razmnoževanja (glejte poglavje 5.3).
English: Initial rapid clearance is through glomerular filtration in the kidney in the first 90 minutes post-infusion.
Slovenian: Začetni hitri očistek poteka prek glomerularne filtracije v ledvica v prvih 90 minutah po infundiranju.
English: No interaction studies have been performed.
Slovenian: Študij medsebojnega delovanja niso izvedli
English: If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.
Slovenian: Če imate kakršna koli dodatna vprašanja o uporabi tega zdravila, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
English: Follow your doctor's advice on how much fluid to drink on the day of your treatment so you stay well hydrated.
Slovenian: Upoštevajte zdravnikova navodila glede količine vode, ki jo morate spiti na dan zdravljenja, da boste ostali hidrirani.
English: Laboratoire Bioluz Zone Industrielle de Jalday 64500 Saint Jean de Luz France
Slovenian: Laboratoire Bioluz Zone Industrielle de Jalday 64500 Saint Jean de Luz Francija
English: Arginine and lysine are rapidly distributed.
Slovenian: Arginin in lizin se hitro porazdelita.
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.
Slovenian: Ni pričakovati interakcij z drugimi zdravili, saj ni informacij o ponovni absorpciji drugih zdravil prek istega mehanizma ponovne absorpcije v ledvicah.
English: This medicinal product is for single use only.
Slovenian: To zdravilo je namenjeno enkratni uporabi.
English: You will receive LysaKare in a controlled clinical setting.
Slovenian: Zdravilo LysaKare boste prejeli v nadzorovanem kliničnem okolju.
English: What LysaKare is and what it is used for 2.
Slovenian: Kaj je zdravilo LysaKare in za kaj ga uporabljamo 2.
English: The recommended dose of LysaKare solution is 1 L (1,000 mL).
Slovenian: Priporočeni odmerek raztopine zdravila LysaKare je 1 l (1.000 ml).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: {DD month YYYY}
Slovenian: Datum prve odobritve: {DD. mesec LLLL}
English: Serum potassium level increases are generally mild and transient.
Slovenian: Povečanja ravni kalija v serumu so na splošno blaga in prehodna.
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.
Slovenian: 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.
English: Do not remove unit from overwrap until ready to use.
Slovenian: Enote ne odstranite iz zunanjega ovoja, dokler niste pripravljeni na uporabo.
English: The main adverse reactions which are related mainly to the amino acid solution are nausea (approximately 25%), vomiting (approximately 10%) and hyperkalaemia.
Slovenian: Glavni neželeni učinki, ki so povezani predvsem z raztopino aminokislin, so navzea (približno 25 %), bruhanje (približno 10 %) in hiperkaliemija.
English: The toxicities that are observed following administration of PRRT are directly due to radiationabsorbed dose to organs.
Slovenian: Toksični učinki, ki so jih opazili po uporabi PRRT, so neposredna posledica doze sevanja, ki jo absorbirajo organi.
English: Pharmacotherapeutic group: All other therapeutic products, detoxifying agents for antineoplastic treatment, ATC code: V03AF11
Slovenian: Farmakoterapevtska skupina: Druga nerazvrščena zdravila za različne bolezni, zdravila za zaščito organizma pri zdravljenju neoplazem, oznaka ATC: V03AF11
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.
Slovenian: V primeru pretirane hidracije ali prevelike količine topljenca, je treba spodbuditi izločanje s pogostim uriniranjem ali s forsirano diurezo in pogostim praznjenjem sečnega mehurja.
English: Do not remove from overwrap until ready for use.
Slovenian: Ne odstranite iz zunanjega ovoja, dokler niste pripravljeni na uporabo.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1381/001
Slovenian: EU/1/19/1381/001
English: Do not use if overwrap has been previously opened or damaged.
Slovenian: Ne uporabljajte, če je bil zunanji ovoj predhodno odprt ali poškodovan.
English: This may indicate that the product is unstable or that the solution has become contaminated.
Slovenian: To je lahko znak nestabilnosti izdelka ali kontaminacije raztopine.
English: What you need to know before you take LysaKare 3.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo LysaKare 3.
English: The correct storage, use and disposal of this medicine are under the responsibility of the specialist in appropriate premises.
Slovenian: Tega zdravila ne boste shranjevali vi. Za pravilno shranjevanje, uporabo in odstranjevanje tega zdravila je odgovoren specialist v primernih prostorih.
English: Serum potassium levels must be tested before each treatment with LysaKare.
Slovenian: Ravni kalija v serumu je treba preveriti pred vsakim zdravljenjem z zdravilom LysaKare.
English: An ECG should be performed prior to discharging the patient.
Slovenian: Po infundiranju je treba pred odpustom bolnika opraviti preiskavo EKG.
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.
Slovenian: 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.
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.
Slovenian: 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.
English: Arginine and lysine, being naturally occurring amino acids, are excreted in human milk, but effects on the breastfed newborns/infants are unlikely.
Slovenian: Arginin in lizin, ki sta naravno prisotni aminokislini, se izločata v mleko pri človeku, vendar učinki na dojene novorojenčke/dojenčke niso verjetni.
English: You should receive the full LysaKare dose, regardless of any Lutathera dose adjustments.
Slovenian: Prejeti morate celoten odmerek zdravila LysaKare, ne glede na morebitne prilagoditve odmerka zdravila Lutathera.
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).
Slovenian: 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).
English: • high potassium levels seen in blood tests, abdominal (belly) pain, headache, dizziness and flushing.
Slovenian: • visoke ravni kalija v krvnih preiskavah, bolečine v abdomnu (trebuhu), glavobol, omotica in vročinski oblivi.
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.
Slovenian: 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.
English: Remaining amino acid is removed by nonrenal clearance.
Slovenian: Preostale aminokisline se odstranijo z neledvičnim očistkom.
English: This reduction in renal radiation exposure mitigates the risk for radiation-induced renal injury.
Slovenian: To zmanjšanje izpostavitve ledvic sevanju zmanjša tveganje za poškodbe ledvic zaradi sevanja.
English: Solution for infusion (infusion).
Slovenian: raztopina za infundiranje (infuzija).
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.
Slovenian: 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.
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.
Slovenian: 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.
English: For other tests which need to be performed before your treatment, please read the Lutathera leaflet.
Slovenian: Za druge preiskave, ki jih je treba opraviti pred zdravljenjem, preberite navodila za uporabo zdravila Lutathera.
English: Other medicines and LysaKare Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Slovenian: Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: Infusion bag made of polyvinyl chloride (PVC) containing 1,000 mL of solution, wrapped in a polyethylene polyamine/aluminium foil.
Slovenian: Infuzijska vreča, izdelana iz polivinilklorida (PVC), ki vsebuje 1.000 ml raztopine, zavita v polietilen poliamin/aluminijevo folijo.
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).
Slovenian: 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).
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.
Slovenian: Izgled zdravila LysaKare in vsebina pakiranja Zdravilo LysaKare je bistra in brezbarvna raztopina za infundiranje, pakirana v prožno vrečo za enkratno uporabo.
English: What you need to know before you take LysaKare
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo LysaKare
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.
Slovenian: 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.
English: LysaKare should be stored below 25°C.
Slovenian: Zdravilo LysaKare je treba shranjevati pri temperaturi do 25 °C.
English: The infusion of LysaKare will start 30 minutes before you are given Lutathera, and will last over a 4 hour period.
Slovenian: Infundiranje zdravila LysaKare se bo začelo 30 minut preden vam dajo zdravilo Lutathera in bo trajalo 4 ure.
English: Liver function (alanine aminotransferase [ALAT], aspartate aminotransferase [ASAT], albumin, bilirubin) should be tested before each administration.
Slovenian: Pred vsako uporabo je treba preveriti delovanje ledvic (ravni alanin-aminotransferaze [ALT], aspartat-aminotransferaze [AST], albumina, bilirubina).
English: The doctor will also check your kidney and liver function before starting the infusion.
Slovenian: Zdravnik bo prav tako pred začetkom infundiranja preveril delovanje ledvic in jeter.
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.
Slovenian: 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.
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.
Slovenian: 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.
English: Care should be taken with LysaKare use in patients with creatinine clearance between 30 and 50 mL/min.
Slovenian: Pri bolnikih s kreatininskim očistkom med 30 in 50 ml/min je potrebna previdnost.
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.
Slovenian: 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.
English: Metabolism and nutrition disorders Hyperkalaemia
Slovenian: Presnovne in prehranske motnje hiperkaliemija
English: Vital signs should be monitored during the infusion regardless of baseline serum potassium levels.
Slovenian: Med infundiranjem je treba spremljati življenjske znake, ne glede na izhodiščne ravni kalija v serumu.
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.
Slovenian: 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.
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.
Slovenian: Spremembe ravnotežja kislin in baz spremenijo ravnotežje zunajceličnega in znotrajceličnega kalija, s hitrimi povečanji koncentracije kalija v plazmi pa je lahko povezan pojav acidoze.
English: What LysaKare is and what it is used for
Slovenian: Kaj je zdravilo LysaKare in za kaj ga uporabljamo
English: LysaKare must not be diluted.
Slovenian: Zdravila LysaKare ne smete redčiti.
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.
Slovenian: 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.
English: Driving and using machines It is considered unlikely that LysaKare will affect your ability to drive or to use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi zdravilo LysaKare vplivajo na vašo sposobnost upravljanja vozil ali strojev.
English: The doctor will check your blood potassium levels, and will correct them if they are too high before starting the infusion.
Slovenian: Zdravnik bo pred začetkom infundiranja preveril ravni kalija v krvi in jih popravil, če so povišane.
English: Due to the intravenous route of administration, LysaKare is 100% bioavailable.
Slovenian: Zdravilo LysaKare je zaradi intravenske poti uporabe 100-% biološko uporabno.
English: How to store LysaKare 6.
Slovenian: Shranjevanje zdravila LysaKare 6.
English: 01630 Saint Genis Pouilly France
Slovenian: 01630 Saint Genis Pouilly Francija
English: Because elderly patients are more likely to have decreased renal function, care should be taken in determining eligibility based on creatinine clearance.
Slovenian: Pri starejših bolnikih je oslabljeno delovanje ledvic bolj verjetno, zato je pri ocenjevanju primernosti na podlagi kreatininskega očistka potrebna previdnost.