FrancophonIA/ELRC3.0 huggingface dataset:
English: Abseamed 6,000 IU/0.6 mL solution for injection in a pre-filled syringe Each mL of solution contains 10,000 IU of epoetin alfa* corresponding to 84.0 micrograms per mL
Slovenian: Abseamed 6.000 i.e./0,6 ml raztopina za injiciranje v napolnjeni injekcijski brizgi En ml raztopine vsebuje 10.000 i.e. epoetina alfa*, kar ustreza 84,0 mikrogramov na ml. 0,6 ml napolnjena injekcijska brizga vsebuje 6.000 mednarodnih enot (i.e.), kar ustreza 50,4 mikrogramov epoetina alfa.
English: Abseamed 3,000 IU/0.3 mL solution for injection in a pre-filled syringe Each mL of solution contains 10,000 IU of epoetin alfa* corresponding to 84.0 micrograms per mL
Slovenian: Abseamed 3.000 i.e./0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi En ml raztopine vsebuje 10.000 i.e. epoetina alfa*, kar ustreza 84,0 mikrogramov na ml. 0,3 ml napolnjena injekcijska brizga vsebuje 3.000 mednarodnih enot (i.e.), kar ustreza 25,2 mikrogramov epoetina alfa.
English: Abseamed 1,000 IU/0.5 mL solution for injection in a pre-filled syringe Each syringe contains 0.5 mL of solution for injection.
Slovenian: Abseamed 1.000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 0,5 ml raztopine za injiciranje.Pakiranja po 1 ali 6 brizg.
English: The patients were between 22 months and 72 years old.
Slovenian: Bolniki so bili stari od 22 mesecev do 72 let.
English: 1081 CN Amsterdam The Netherlands
Slovenian: 1081 CN Amsterdam Nizozemska
English: The fate of the remainder is undetermined.
Slovenian: Usoda preostanka ni znana.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/ema/.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/ema/.
English: A specialized antidote is not available.
Slovenian: Specifični antidot ni na voljo.
English: Emetogenic potential.
Slovenian: Emetogeni potencial.
English: The duration of the treatment is determined by the doctor and may vary for each patient.
Slovenian: Trajanje zdravljenja določi zdravnik in je lahko pri vsakem bolniku drugačno.
English: Lung damage may occur years after treatment.
Slovenian: Poškodba pljuč se lahko pojavi več let po zdravljenju.
English: Two of these 8 fatalities occurred within the first 3 years of treatment and 6 of them occurred 8-13 years after treatment.
Slovenian: Dva od teh osmih primerov sta se pojavila v prvih treh letih zdravljenja, šest pa se jih je pojavilo od 8 do 13 let po zdravljenju.
English: This medicinal product should not be used any further.
Slovenian: To zdravilo se ne sme več uporabljati.
English: It is usually given at least every 6 weeks.
Slovenian: Običajno se daje na vsakih šest tednov.
English: This medicine will be stored by your doctor or health care professional.
Slovenian: To zdravilo bo shranil vaš zdravnik ali zdravstveni delavec.
English: Compatibility/Incompatibility with containers
Slovenian: Kompatibilnost/inkompatibilnost z vsebniki
English: Your doctor will talk to you about the possibility of lung damage and allergic reactions and their symptoms.
Slovenian: Vaš zdravnik se bo pogovoril z vami o možnosti poškodbe pljuč in alergijskih reakcij ter njihovih simptomov.
English: Reconstitution and further dilutions should be carried out under aseptic conditions.
Slovenian: Rekonstitucijo in nadaljnja redčenja je treba opravljati pod aseptičnimi pogoji.
English: This medicine may cause severe (possibly fatal) lung damage.
Slovenian: To zdravilo lahko povzroči hudo (morebiti smrtno) poškodbo pljuč.
English: As a doctor or nurse will be giving you this medicine, it is unlikely that you will receive an incorrect dose.
Slovenian: Ker vam bo to zdravilo dal zdravnik ali medicinska sestra, je le malo verjetno, da bi prejeli neustrezen odmerek.
English: The median age of patients who died on treatment was 2.5 years (1-12 years), the median age of long-term survivors on treatment was 10 years (5-16 years).
Slovenian: Srednja starost bolnikov, ki so ob zdravljenju umrli, je bila 2,5 leta (od 1 do 12 let), srednja starost tistih, ki so ob zdravljenju dolgotrajno preživeli, pa je bila 10 let (od 5 do 16 let).
English: Doses will be adjusted according to how you respond to the treatment.
Slovenian: Odmerki bodo prilagojeni glede na to, kako se odzivate na zdravljenje.
English: Store and transport refrigerated (2°C - 8°C).
Slovenian: Shranjujte in prevažajte na hladnem (2°C - 8°C).
English: The amount of alcohol in this medicine may alter the effects of other medicines.
Slovenian: Količina alkohola v tem zdravilu lahko spremeni učinke drugih zdravil.
English: Approximately 60-70% of a total dose is excreted in the urine in 96 hours and about 10% as respiratory CO2.
Slovenian: V 96 urah se približno od 60 do 70 odstotkov celotnega odmerka izloči z urinom, približno 10 odstotkov pa kot izdihani CO2.
English: Such products are not accepted for use due to the risk of temperature excursions to more than 30°C.
Slovenian: Taka zdravila niso sprejemljiva za uporabo zaradi nevarnosti nihanja temperature za več kot 30 °C.
English: Therefore this medicine should not normally be administered to pregnant women.
Slovenian: To zdravilo se zato običajno ne sme dajati nosečnicam.
English: Dosage is based on your medical condition, body size and response to treatment.
Slovenian: Odmerek je odvisen od vašega zdravstvenega stanja, telesne velikosti in odziva na zdravljenje.
English: Safe use in pregnancy has not been established and therefore the benefit must be carefully weighed against the risk of toxicity.
Slovenian: Varna uporaba med nosečnostjo ni dokazana, zato morajo biti koristi skrbno pretehtane glede na tveganje za toksičnost.
English: All remaining survivors available for follow-up were diagnosed with pulmonary fibrosis.
Slovenian: Vsem preživelim, ki so bili na voljo za spremljanje, je bila postavljena diagnoza pljučne fibroze.
English: if you are allergic to carmustine or any of the other ingredients of this medicine (listed in section 6).
Slovenian: če ste alergični na karmustin ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
English: For dissolving purposes only
Slovenian: Samo za namene raztapljanja
English: The presence of an oily film can be an indication of melting of the medicinal product.
Slovenian: Prisotnost oljnega filma je lahko znak taljenja zdravila.
English: The following schedule is suggested as a guide to dosage adjustment:
Slovenian: Kot vodilo za prilagajanje odmerjanja se predlaga naslednji razpored:
English: When you are not clear about the fact whether the product is adequately cooled, then you should immediately inspect each and every vial in the carton.
Slovenian: Če niste prepričani, ali je zdravilo dovolj ohlajeno, morate takoj pregledati vsako vialo v škatli.
English: This may be given as a single dose or divided into daily infusions such as 75 to 100 mg/m2 on two successive days.
Slovenian: To se lahko daje v obliki enega odmerka ali razdeljeno na dnevne infuzije, npr. od 75 do 100 mg/m2 v dveh zaporednih dneh.
English: Initial doses
Slovenian: Začetni odmerki
English: Levels of radioactivity in the cerebrospinal fluid are at least 50% higher than those measured concurrently in plasma.
Slovenian: Ravni radioaktivnosti v cerebrospinalni tekočini so vsaj za 50 odstotkov višje kot ravni, sočasno izmerjene v plazmi.
English: In case the tumor remains incurable or some serious or intolerable adverse reactions appear, the carmustine therapy must be terminated.
Slovenian: Kadar ostane tumor neozdravljiv ali se pojavijo nekateri resni ali nevzdržni neželeni učinki, je treba zdravljenje s karmustinom končati.
English: For verification, hold the vial in bright light.
Slovenian: Za preverjanje držite vialo pri močni svetlobi.
English: By following the recommended storage conditions it is possible to avoid any decomposition of the unopened vial until the date of expiry mentioned on the packaging.
Slovenian: Z upoštevanjem priporočenih pogojev shranjevanja se je mogoče izogniti vsemu razpadu neodprte viale do datuma izteka, navedenega na ovojnini.
English: Monitoring and subsequent doses
Slovenian: Spremljanje in nadaljnji odmerki
English: In patients having received carmustine in childhood or adolescence, cases of extremely delayedonset pulmonary fibrosis (up to 17 years after treatment) have been described.
Slovenian: Pri bolnikih, ki so prejemali karmustin v otroštvu ali adolescenci, so opisali primere pljučne fibroze, ki se je pojavila izjemno pozno (do 17 let po zdravljenju).
English: Carmustine Obvius should not be used during pregnancy because it may harm your unborn baby.
Slovenian: Zdravilo Karmustin Obvius se ne sme uporabljati med nosečnostjo, ker lahko škoduje vašemu nerojenemu otroku.
English: The half-life α is 1-4 minutes and the half-life β is 18-69 minutes.
Slovenian: Razpolovni čas α je od ene do štirih minut, razpolovni čas β pa od 18 do 69 minut.
English: This corresponds to 11.2 ml of beer or 4.65 ml wine, per dose.
Slovenian: To ustreza 11,2 ml piva ali 4,65 ml vina na odmerek.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 10.
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET 10.
English: In combination with chemotherapeutic medicinal products reduced activity of antiepileptic medicinal products must be anticipated.
Slovenian: V kombinaciji s kemoterapevtskimi zdravili je treba pričakovati zmanjšano delovanje antiepileptičnih zdravil.
English: Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed may not reflect the rates observed in clinical practice.
Slovenian: Ker se klinična preskušanja izvajajo pod zelo specifičnimi pogoji, opažene pogostnosti neželenih učinkov morda ne izražajo ustrezno v klinični praksi opaženih pogostnosti.
English: When placebo-controlled trials are available, adverse reactions are included if the incidence is ≥ 5% higher in the treatment group.
Slovenian: Kadar so na voljo s placebom nadzorovana preskušanja, so neželeni učinki vključeni, če je incidenca pri zdravljeni skupini višja za ≥ 5 %.
English: Pulmonary fibrosis (with fatal outcome), pulmonary infiltration
Slovenian: Pljučna fibroza (s smrtnim izidom), pljučna infiltracija
English: The main symptom of intoxication is myelosuppression.
Slovenian: Glavni simptom zastrupitve je mielosupresija.
English: In addition, the following serious adverse reactions may occur: liver necrosis, interstitial pneumonitis, encephalomyelitis.
Slovenian: Poleg tega se lahko pojavijo naslednji resni neželeni učinki: nekroza jeter, intersticijski pnevmonitis, encefalomielitis.
English: - Secondary therapy in non-Hodgkin's lymphoma and Hodgkin's disease
Slovenian: - sekundarni terapiji ne-Hodgkinovega limfoma in Hodgkinove bolezni
English: The kinetic of carmustine in humans is characterised by a two-chamber model.
Slovenian: Za kinetiko karmustina pri človeku je značilen dvoprekatni model.
English: Ethanol.
Slovenian: Etanol.
English: This information is a short description of preparation and/or handling, incompatibilities, posology of the medicine, overdose or monitoring measures and laboratory investigations based on the current SmPC.
Slovenian: Te informacije so kratek opis pripravka in/ali ravnanja z zdravilom, inkompatibilnosti, odmerjanja zdravila, prevelikega odmerjanja ter spremljanja in laboratorijskih preiskav na podlagi trenutnega povzetka glavnih značilnosti zdravila.
English: The table includes adverse reactions that were presented during treatment with this medicinal product but may not necessarily have a causal relationship with the medicinal product.
Slovenian: Preglednica vključuje neželene učinke, ki so se pojavili med zdravljenjem s tem zdravilom, vendar niso nujno vzročno povezani z njim.
English: All patients younger than 5 years of age at the time of treatment died from pulmonary fibrosis; neither the carmustine dose nor an additional vincristine dose or spinal radiation had any influence on the fatal outcome.
Slovenian: Vsi bolniki, ki so bili v času začetka zdravljenja mlajši od pet let, so umrli zaradi pljučne fibroze; na smrtni izid niso vplivali niti odmerek karmustina niti dodatni odmerek vinkristina ali obsevanje hrbtenice.
English: Carmustine is effective in the following malignant neoplasms as a single agent or in combination with other antineoplastic agents and/or other therapeutic measures (radiotherapy, surgery):
Slovenian: Karmustin je učinkovit pri naslednjih malignih novotvorbah kot samostojno zdravilo ali v kombinaciji z drugimi antineoplastičnimi zdravili in/ali drugimi terapevtskimi ukrepi (obsevanjem, kirurškim posegom):
English: Powder: white to almost white powder or lyophilisate.
Slovenian: Prašek: bel do skoraj bel prašek ali liofilizat.
English: Dosage will also depend on whether Carmustine Obvius is given with other anti-cancer medicines.
Slovenian: Odmerek bo odvisen tudi od tega, ali se bo zdravilo Karmustin Obvius dajalo z drugimi zdravili proti raku.
English: However, opinion is divided over the role of the carbamoylating intermediates as mediators of the biological effects of the nitrosoureas.
Slovenian: Vendar so mnenja o vlogi karbamoilirajočih intermediatov kot posrednikov bioloških učinkov nitrozosečnin deljena.
English: To be taken into account in high-risk groups such as patients with liver disease or epilepsy.
Slovenian: To je treba upoštevati pri ogroženih skupinah, kot so bolniki z boleznijo jeter ali epilepsijo.
English: Because of the good lipid solubility and the lack of ionisation at the physiological pH, carmustine is very well transferred through the blood-brain barrier.
Slovenian: Zaradi dobre lipidotopnosti in pomanjkanja ionizacije pri fiziološkem pH karmustin zelo dobro prehaja skozi krvno-možgansko pregrado.
English: During administration of the medicinal product, the container shall be of suitable glass ware.
Slovenian: Med dajanjem zdravila mora biti vsebnik iz primernega stekla.
English: The 30 ml stock solution needs to be mixed thoroughly.
Slovenian: 30 ml osnovne raztopine je treba temeljito premešati.
English: The intravenous solution is unstable in polyvinyl chloride containers.
Slovenian: Intravenska raztopina je v polivinilkloridnih vsebnikih nestabilna.
English: Hypersensitivity to the active substance, to other nitrosoureas or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na učinkovino, druge nitrozouree ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Renal toxicity Renal toxicity is rare, but occurs for cumulative doses < 1,000 mg/m2.
Slovenian: Ledvična toksičnost Ledvična toksičnost je redka, vendar se pojavi pri kumulativnih odmerkih < 1 000 mg/m2.
English: Dermatitis with topical use improves with reduced concentration of compounded product, hyperpigmentation, transient, with accidental skin contact.
Slovenian: Dermatitis ob topični uporabi se izboljša ob zmanjšani koncentraciji sestavljenega zdravila, hiperpigmentacija, prehodna, ob naključnem stiku s kožo.
English: If used during pregancy, the patient must be aware of the potential risk to the unborn baby.
Slovenian: Pri uporabi med nosečnostjo mora biti bolnica seznanjena s potencialnim tveganjem za nerojenega otroka.
English: Pneumonitis.
Slovenian: Pnevmonitis.
English: Direct administration of carmustine into the carotid artery is regarded as experimental and has been associated with ocular toxicity.
Slovenian: Neposredno dajanje karmustina v karotidno arterijo velja za eksperimentalno in ga povezujejo z očesno toksičnostjo.
English: The dry frozen product does not contain any preservatives and is suitable only for one use.
Slovenian: Suho zmrznjeno zdravilo ne vsebuje konzervansov in je primerno samo za enkratno uporabo.
English: In cases where pulmonary toxicity started early (within 3 years of treatment), pulmonary infiltrates and/or pulmonary fibrosis occurred, some of which were fatal.
Slovenian: Če se je zastrupitev pljuč pojavila zgodaj (v treh letih po zdravljenju), so se pojavili pljučni infiltrati in/ali pljučna fibroza, od katerih so bili nekateri smrtni.
English: Blood counts should be monitored frequently and repeat courses should not be given before six weeks because of delayed haematologic toxicity.
Slovenian: Število krvnih celic je treba spremljati pogosto, ponovni cikli zdravljenja pa se zaradi zapoznele hematološke toksičnosti ne smejo začeti pred potekom šestih tednov.
English: You must check with your doctor before driving or operating any tools or machines because the amount of alcohol in this medicine may impair your ability to drive or use machines.
Slovenian: Pred upravljanjem vozil ali katerih koli orodij ali strojev se morate posvetovati z zdravnikom, saj lahko količina alkohola v tem zdravilu vpliva na vašo sposobnost vožnje ali uporabe strojev.
English: Males should be advised of potential risk of infertility and to seek fertility/family planning counselling prior to therapy with carmustine .
Slovenian: Moške je treba poučiti o možnem tveganju za neplodnost in jim priporočiti, naj se pred zdravljenjem s karmustinom posvetujejo glede plodnosti/načrtovanja družine.
English: This medicine contains 0.57 vol% ethanol (alcohol), which means 7.62 g per dose.
Slovenian: To zdravilo vsebuje 0,57 vol% etanola (alkohola), kar pomeni 7,62 g na odmerek.
English: The carbamoylating activity of carmustine is generally considered less significant than the alkylating activity in its action on tumors, but carbamoylation may serve to inhibit DNA repair.
Slovenian: Za karbamoilirajoče učinkovanje karmustina se na splošno šteje, da je za njegovo delovanje na tumorje manj pomembno kot alkilacijsko delovanje, vendar je karbamoilacija morda pomembna za zaviranje popravljanja DNA.
English: Pulmonary toxicity has been observed in up to 30% of patients.
Slovenian: Pri do 30 % bolnikov je bila opažena zastrupitev pljuč.
English: It is unknown whether carmustine/metabolites are excreted in human milk.
Slovenian: Ni znano, ali se karmustin/presnovki izločajo v materino mleko.
English: The recommended dose of Carmustine Obvius as a single agent in previously untreated patients is 150 to 200 mg/m2 intravenously every 6 weeks.
Slovenian: Priporočeni odmerek zdravila Karmustin Obvius kot samostojnega zdravila pri predhodno nezdravljenih bolnikih je od 150 do 200 mg/m2 intravensko na vsakih šest tednov.
English: Melphalan Concomitant use with melphalan leads to increased risk of pulmonary toxicity.
Slovenian: Sočasna uporaba z melfalanom povečuje tveganje za zastrupitev pljuč.
English: Severe (end-stage) renal impairment.
Slovenian: Huda (končna) okvara ledvic.
English: What Carmustine Obvius is and what it is used for
Slovenian: Kaj je zdravilo Karmustin Obvius in za kaj ga uporabljamo
English: Posology and laboratory investigations
Slovenian: Odmerjanje in laboratorijske preiskave
English: After reconstitution Carmustine Obvius is stable for 3 hours, stored in a glass container and protected from light.
Slovenian: Po rekonstituciji je zdravilo Karmustin Obvius stabilno tri ure, shranjeno v steklenem vsebniku in zaščiteno pred svetlobo.
English: Intravenously administered carmustine is rapidly degraded, with no substance intact detectable after 15 minutes.
Slovenian: Intravensko aplicirani karmustin se hitro razgrajuje in po 15 minutah ni več zaznavne intaktne snovi.
English: Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body), and feeling you are going to faint.
Slovenian: Kakršno koli nenadno piskanje, težave z dihanjem, otekanje vek, obraza ali ustnic, izpuščaj ali srbenje (še posebej, če je prizadeto vse vaše telo) in občutek, da boste omedleli.
English: Interstitial fibrosis (with lower doses).
Slovenian: Intersticijska fibroza (pri manjših odmerkih).
English: Concomitant use with digoxin leads to delayed, moderate, suspected, decreased effect of digoxin (due to the decreased digoxin absorption).
Slovenian: Sočasna uporaba z digoksinom povzroči odložen, zmeren, domnevni zmanjšani učinek digoksina (zaradi zmanjšane absorpcije digoksina).
English: Carmustine must be completely dissolved in ethanol before sterile water for injections is added.
Slovenian: Karmustin je treba pred dodatkom sterilne vode za injekcije popolnoma raztopiti v etanolu.
English: Carmustine Obvius will always be given to you by a healthcare professional with experience in the use of anticancer medicines.
Slovenian: Zdravilo Karmustin Obvius vam bo vedno dal zdravstveni delavec z izkušnjami z uporabo zdravil proti raku.
English: In case of a decreased number of circulating platelets, leucocytes or erythrocytes either from previous chemotherapy or other cause the dose should be adjusted, see Table 1, section 4.2.
Slovenian: V primeru zmanjšanega števila trombocitov, levkocitov ali eritrocitov v obtoku zaradi predhodne kemoterapije ali drugega vzroka je treba odmerek prilagoditi; glejte preglednico 1, poglavje 4.2.
English: Therefore your doctor will monitor blood counts weekly for at least 6 weeks after a dose.
Slovenian: Zdravnik bo zato vsaj šest tednov po odmerku tedensko spremljal število krvnih celic.
English: Carmustine Obvius contains ethanol (alcohol)
Slovenian: Zdravilo Karmustin Obvius vsebuje etanol (alkohol)
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness:
Slovenian: V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti:
English: There are no limits for the period of application of carmustine therapy.
Slovenian: Za trajanje zdravljenja s karmustinom ni časovnih omejitev.
English: Carmustine Obvius may cause the following side effects:
Slovenian: Zdravilo Karmustin Obvius lahko povzroči naslednje neželene učinke:
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake „UPORABNO DO“.
English: Nausea and vomiting are severe and begins within 2-4 h of administration and lasts for 4-6 h.
Slovenian: Slabost in bruhanje sta huda in se začneta v dveh do štirih urah po dajanju ter trajata od štiri do šest ur.
English: if you suffer from suppression of blood cell formation in the bone marrow and the number of your platelets, white blood cells (leucocytes), or red blood cells (erythrocytes) is therefore reduced, either as a result of chemotherapy or other causes.
Slovenian: če trpite zaradi zavrte tvorbe krvnih celic v kostnem mozgu in je zato število trombocitov, belih krvnih celic (levkocitov) ali rdečih krvničk (eritrocitov) zaradi kemoterapije ali drugih razlogov pri vas zmanjšano;
English: In addition, carmustine is known to carbamoylate lysine residues on proteins causing irreversible inactivation of enzymes including glutathione reductase.
Slovenian: Poleg tega je za karmustin znano, da karbamoilira lizinske ostanke na beljakovinah, s čimer povzroča ireverzibilno inaktivacijo encimov, vključno z glutation reduktazo.
English: When Carmustine Obvius is used in combination with other myelosuppressive medicinal products or in patients in whom bone marrow reserve is depleted, the doses should be adjusted according to the haematologic profile of the patient as shown below.
Slovenian: Kadar se zdravilo Karmustin Obvius uporablja v kombinaciji z drugimi mielosupresivnimi zdravili ali pri bolnikih, pri katerih je porabljena rezerva kostnega mozga, je treba odmerke prilagoditi glede na hematološki profil bolnika, kot je prikazano spodaj.
English: Pulmonary toxicity also manifested in the post-marketing phase as pneumonitis and interstitial lung disease.
Slovenian: Zastrupitev pljuč se je pokazala tudi v obdobju trženja, in sicer kot pnevmonitis in intersticijska bolezen pljuč.
English: What you need to know before you use Carmustine Obvius Do not use Carmustine Obvius:
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Karmustin Obvius Ne uporabljajte zdravila Karmustin Obvius:
English: if you suffer from higher-grade kidney dysfunction.
Slovenian: če imate motnjo delovanja ledvic višje stopnje;