FrancophonIA/ELRC3.0 huggingface dataset:
English: It works by reducing production of transthyretin by the liver and so lowers the risk of fibres of transthyretin being deposited in body organs and causing symptoms.
Slovenian: Deluje z zaviranjem proizvodnje transtiretina v jetrih ter tako zmanjša tveganje, da bi se vlakna transtiretina nalagala v telesnih organih in povzročala simptome.
English: P-value
Slovenian: Vrednost P
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1296/001
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/18/1296/001 EU/1/18/1296/002
English: Patients were stratified for stage of disease (Stage 1 versus Stage 2), TTR mutation (V30M versus non-V30M) and previous treatment with either tafamidis or diflunisal (yes versus no).
Slovenian: Bolniki so bili stratificirani glede na stadij bolezni (1. stadij ali 2. stadij), mutacijo TTR (V30M ali ne-V30M) in predhodno zdravljenje s tafamidisom ali diflunisalom (da ali ne).
English: It is unknown if continuation of your vitamin A supplementation with 3000 IU per day will be harmful to your unborn child in the first trimester of your pregnancy, but this dose should not be exceeded.
Slovenian: Ni znano, ali nadaljevanje z uporabo dodatka vitamina A v dnevni količini 3.000 i.e. škoduje nerojenemu otroku v prvem trimesečju nosečnosti, vendar tega odmerka ne smete preseči.
English: Recommendations for adjustments to monitoring frequency and inotersen dosing are specified in Table 1 (see section 4.2).
Slovenian: Priporočila za prilagajanje pogostosti spremljanja in odmerjanja inotersena so v preglednici 1 (glejte poglavje 4.2).
English: PHARMACEUTICAL FORM Solution for injection (injection) Clear, colourless to pale yellow solution (pH 7.5 - 8.8)
Slovenian: FARMACEVTSKA OBLIKA raztopina za injiciranje (injekcija) Bistra, brezbarvna do bledo rumena raztopina (pH 7,5-8,8)
English: Development of anti-drug antibodies to inotersen was characterised by late onset (median onset > 200 days) and low titer (median peak titer of 284 in the pivotal study).
Slovenian: Za razvoj protiteles proti inotersenu sta bila značilna pozen nastop (mediani nastop > 200 dni) in nizek titer (mediani najvišji titer 284 v ključni študiji).
English: What Tegsedi is and what it is used for 2.
Slovenian: Kaj je zdravilo Tegsedi in za kaj ga uporabljamo 2.
English: This prevents the synthesis of TTR protein in the liver, resulting in significant reductions in the levels of mutated and wild type TTR protein secreted by the liver into the circulation.
Slovenian: To preprečuje sintezo beljakovine TTR v jetrih, kar ima za posledico pomembno zmanjšanje ravni mutiranega in divjega tipa beljakovine TTR, ki se izloča iz jeter v krvni obtok.
English: Both excess and deficient levels of vitamin A can harm the development of your unborn child.
Slovenian: Tako prevelike kot premajhne ravni vitamina A lahko škodujejo razvoju nerojenega otroka.
English: Urine protein to creatinine ratio (UPCR) ≥ 113 mg/mmol (1 g/g) prior to treatment.
Slovenian: Razmerje med beljakovinami in kreatininom v urinu (UPCR) ≥ 113 mg/mmol (1 g/g) pred zdravljenjem
English: In the pivotal NEURO-TTR study, in the inotersen treatment group, robust reduction in circulating TTR levels was observed throughout the 15-month treatment period, with mean percent changes from baseline in serum TTR ranging from 68.41% to 74.03% (median range: 74.64% to 78.98%) from Week 13 to Week 65 (Figure 1).
Slovenian: V ključni študiji NEURO-TTR so v skupini, zdravljeni z inotersenom, opažali močno zmanjšanje ravni krožečega TTR skozi celotno 15-mesečno obdobje zdravljenja, pri čemer so se povprečne odstotne spremembe serumskih ravni TTR glede na izhodišče od 13. do 65. tedna gibale med 68,41 % in 74,03 % (mediani razpon: od 74,64 % do 78,98 %) (slika 1).
English: Injury, poisoning and procedural complications
Slovenian: Poškodbe, zastrupitve in zapleti pri posegih kontuzija
English: Each pre-filled syringe should be used only once and then placed in a sharps disposal container for disposal.
Slovenian: Vsako napolnjeno injekcijsko brizgo se sme uporabiti samo enkrat, nato jo je treba zavreči v posodo za odlaganje ostrih odpadkov.
English: It is unknown whether inotersen/metabolites are excreted in human milk.
Slovenian: Ni znano, ali se inotersen/presnovki izločajo v materino mleko.
English: These pro-inflammatory organ changes were observed at 1.4 to 6.6-fold the human AUC at the recommeded therapeutic dose in all animal species tested and were accompanied by increases of various plasma cytokines/chemokines.
Slovenian: Te provnetne spremembe v organih so opazili pri od 1,4- do 6,6-krat višjih vrednostih AUC, kot bi jih pri ljudeh dosegli s priporočenim terapevtskim odmerkom, pri vseh preskušanih živalskih vrstah in spremljale so jih povišane ravni različnih plazemskih citokinov/kemokinov.
English: - The other ingredients are water for injections, sodium hydroxide, and hydrochloric acid.
Slovenian: - Druge sestavine zdravila so voda za injekcije, natrijev hidroksid in klorovodikova kislina.
English: Do not take a double dose to make up for a forgotten dose.
Slovenian: Ne uporabite dvojnega odmerka, če ste pozabili uporabiti prejšnji odmerek.
English: If vitamin A supplementation is continued, the daily dose should not exceed 3000 IU per day, due to the lack of data supporting higher doses.
Slovenian: Če se dodajanje vitamina A nadaljuje, dnevni odmerek ne sme presegati 3.000 i.e. vitamina A na dan, zaradi pomanjkanja podatkov, ki bi podpirali večje odmerke.
English: This does not mean that the injection is finished.
Slovenian: To je normalno, vendar ne pomeni, da je injiciranje končano.
English: The active substance in Tegsedi, inotersen, is a type of medicine called an antisense oligonucleotide inhibitor.
Slovenian: Učinkovina v zdravilu Tegsedi, inotersen, je vrsta zdravila, ki se imenuje protismerni oligonukleotidni zaviralec.
English: Animal studies did not indicate any impact of inotersen on male or female fertility.
Slovenian: Študije na živalih niso pokazale nobenih učinkov inotersena na plodnost samcev ali samic.
English: Do not use this medicine if you notice that the contents are cloudy or contains particles.
Slovenian: Tega zdravila ne uporabljajte, če opazite, da je raztopina motna ali vsebuje delce.
English: Do not use if the expiry date has passed.
Slovenian: Izdelka ne uporabite, če je rok uporabnosti potekel.
English: Based on the population pharmacokinetic analysis, age, body weight, sex or race has no clinically relevant effect on inotersen exposure.
Slovenian: Na podlagi populacijske farmakokinetične analize starost, telesna masa, spol in rasa nimajo klinično pomembnega učinka na izpostavljenost inotersenu.
English: It is used to treat adults with hereditary transthyretin amyloidosis.
Slovenian: Uporablja se za zdravljenje odraslih z dedno transtiretinsko amiloidozo.
English: You doctor will measure these, and if they are already low, this should be corrected and any symptoms resolved before you start treatment with Tegsedi.
Slovenian: Zdravnik bo izmeril ravni tega vitamina in če so že nizke, je to treba popraviti in odpraviti morebitne simptome, preden se začnete zdraviti z zdravilom Tegsedi.
English: Furthermore, results across the components of mNIS+7 and domains of Norfolk QoL-DN composite scores were consistent with the primary endpoint analysis, showing benefit in motor, sensory and autonomic neuropathies (Figure 2).
Slovenian: Poleg tega so bili rezultati komponent mNIS+7 in deli sestavljenih rezultatov vprašalnika Norfolk QoL-DN skladni z analizo primarnih opazovanih dogodkov ter kažejo koristnost pri motoričnih, senzoričnih in avtonomnih nevropatijah (slika 2).
English: Week 66 Change n LSM (SE) 95% CI Difference in LSM (Tegsedi - Placebo) 95% CI P-value
Slovenian: Sprememba v 66. tednu n LSM (SE) 95-odstotni IZ Razlika v LSM (Tegsedi - Placebo) 95-odstotni IZ Vrednost P
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Tegsedi therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Tegsedi, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: Age (years), mean (SD) Age 65 years and older, n (%) Male, n (%) mNIS+7, mean (SD)
Slovenian: Starost (leta), srednja vrednost (SD) Starost 65 let in več, n (%) Moški, n (%) mNIS+7, srednja vrednost (SD) Norfolk QoL-DN, srednja vrednost (SD) Stadij bolezni, n (%)
English: 9/L were observed in 23% of patients treated with inotersen and 2% of the patients receiving placebo; confirmed platelet counts of < 75 x 109/L were observed in 10.7% of inotersen-treated patients.
Slovenian: 9/l so opazili pri 23 % bolnikov, ki so se zdravili z inotersenom, in pri 2 % bolnikov, ki so prejemali placebo; 10,7 % bolnikov, ki so se zdravili z inotersenom, je imelo potrjeno število trombocitov < 75 x 109/l.
English: The NEURO-TTR multicentre, double-blind, placebo-controlled trial was comprised of 172 treated patients with hereditary transthyretin amyloidosis with polyneuropathy (hATTR-PN).
Slovenian: Multicentrično, dvojno slepo, s placebom nadzorovano preskušanje NEURO-TTR je vključevalo 172 zdravljenih bolnikov z dedno transtiretinsko amiloidozo s polinevropatijo (hATTR-PN).
English: It is not known whether vitamin A supplementation will be sufficient to reduce the risk to the foetus (see section 4.4).
Slovenian: Ni znano, ali bo dodajanje vitamina A zadostovalo za zmanjšanje tveganja za plod (glejte poglavje 4.4).
English: Available pharmacodynamic/toxicological data in animals have shown excretion of inotersen metabolites in milk (see section 5.3).
Slovenian: Razpoložljivi farmakodinamični/toksikološki podatki pri živalih kažejo na izločanje presnovkov inotersena v mleko (glejte poglavje 5.3).
English: Based on the mechanism of action, inotersen is expected to reduce plasma vitamin A (retinol) below normal levels (see section 5.1).
Slovenian: Na podlagi mehanizma delovanja se pričakuje, da bo intersen zmanjšal ravni vitamina A (retinola) v plazmi pod spodnjo normalno mejo (glejte poglavje 5.1).
English: Slowly and firmly push the plunger all the way down until the medicine is injected.
Slovenian: Počasi in močno potisnite bat do konca navzdol, da se injicira celotni odmerek zdravila.
English: Then monitor twice weekly until 3 successive values above 75.
Slovenian: Nato spremljanje dvakrat tedensko, dokler niso 3 zaporedne vrednosti nad 75.
English: Injection should be avoided at the waistline and other sites where pressure or rubbing from clothing may occur.
Slovenian: Injiciranje okoli pasu in na drugih predelih, kjer lahko pride do pritiska ali drgnjenja oblačil, ni priporočljivo.
English: Do not inject where skin is bruised, tender, red or hard.
Slovenian: Zdravila ne injicirajte na predele, kjer je koža poškodovana, občutljiva, rdeča ali otrdela.
English: If you develop glomerulonephritis, your doctor will treat you for this condition.
Slovenian: Če se pri vas razvije glomerulonefritis, bo vaš zdravnik poskrbel za zdravljenje.
English: • To have a list of all other medicines they are using for any visit to a Health Care Professionals (HCP);
Slovenian: • da morajo na vsak obisk pri zdravniku prinesti seznam vseh drugih zdravil, ki jih uporabljajo.
English: Inotersen will reduce the plasma levels of vitamin A, which is crucial for normal foetal development.
Slovenian: Inotersen bo znižal plazemske ravni vitamina A, ki je ključnega pomena za normalen razvoj ploda.
English: Platelet and renal function tests should be monitored regularly.
Slovenian: Redno je treba opravljati preiskave trombocitov in delovanja ledvic.
English: Do not inject the medicine until you have gathered the supplies listed.
Slovenian: Zdravila ne injicirajte, dokler nimate pripravljenih naštetih predmetov.
English: Dosing should be adjusted according to laboratory values as follows:
Slovenian: Odmerjanje je treba prilagoditi glede na laboratorijske vrednosti, kot sledi: Preglednica 1.
English: Tegsedi may pass into breast milk.
Slovenian: Zdravilo Tegsedi lahko prehaja v materino mleko.
English: Stage 1
Slovenian: 1. stadij
English: Gather supplies
Slovenian: Pripravite potrebščine
English: Stage I Disease
Slovenian: Bolezen v I. stadiju
English: Although the population PK analysis did not identify clinically relevant effects of some nephrotoxic medicines on the clearance of inotersen or on the potential for an effect on renal function, a systematic assessment of co-administration of inotersen and potentially nephrotoxic medicinal products has not been conducted.
Slovenian: Čeprav pri analizi populacijske FK niso identificirali klinično pomembnih vplivov nekaterih nefrotoksičnih zdravil na očistek inotersena ali potenciala za vpliv na delovanje ledvic, sočasna uporaba inotersena in potencialno nefrotoksičnih zdravil ni bila sistematično ocenjena.
English: • Advise HCPs that, due to the risks of thrombocytopenia and glomerulonephritis, patients should have their platelet count monitored at least every 2 weeks, and urine to protein creatinine ratio and estimated glomerular filtration rate monitored at least every 3 months;
Slovenian: • svetovati zdravstvenim delavcem, da je treba zaradi tveganja za trombocitopenijo in glomerulonefritis pri bolnikih spremljati število trombocitov vsaj vsaka 2 tedna ter razmerje med beljakovinami in kreatininom v urinu ter ocenjeno stopnjo glomerulne filtracije vsaj vsake 3 mesece;
English: Estimated glomerular filtration rate (eGFR) < 45 ml/min/1.73m
Slovenian: Ocenjena hitrost glomerulne filtracije (eGFR) < 45 ml/min/1,73 m Huda okvara jeter
English: Glomerulonephritis is a condition of your kidneys, where they do not work properly due to inflammation and kidney damage.
Slovenian: Glomerulonefritis je bolezen ledvic, pri kateri ledvice ne delujejo pravilno zaradi vnetja in poškodbe.
English: If unrefrigerated and not used within 6 weeks then this medicine should be discarded.
Slovenian: Če zdravilo ni shranjeno v hladilniku in se ne uporabi v 6 tednih, ga je treba zavreči.
English: No effect on the pharmacokinetic properties (Cmax, AUC or half-life) and efficacy of inotersen was observed in the presence of anti-drug antibodies, but patients with anti-drug antibodies had more reactions at the injection site.
Slovenian: Ob prisotnosti protiteles proti zdravilu niso opazili nobenih učinkov na farmakokinetične lastnosti (Cmax, AUC ali razpolovni čas) in učinkovitost inotersena, vendar so imeli bolniki s protitelesi proti zdravilu več reakcij na mestu injiciranja.
English: If you are of child-bearing age and intend to use Tegsedi, you should practise effective contraception.
Slovenian: Če ste v rodni dobi in nameravate uporabljati zdravilo Tegsedi, morate uporabljati učinkovito kontracepcijo.
English: Thereafter, vitamin A supplementation of 3000 IU per day should be resumed in the second and third trimester if plasma retinol levels have not yet returned to normal, because of the increased risk of vitamin A deficiency in the third trimester.
Slovenian: Pozneje je treba dodajanje vitamina A v odmerku 3.000 i.e na dan nadaljevati v drugem in tretjem trimesečju, če se ravni retinola v plazmi še niso vrnile v normalni razpon, saj obstaja povečano tveganje za pomanjkanje vitamina A v tretjem trimesečju
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: Tegsedi may be stored unrefrigerated for up to 6 weeks at a temperature below 30°C.
Slovenian: Zdravilo Tegsedi se lahko shranjuje zunaj hladilnika do 6 tednov, če je temperatura nižja od 30 °C.
English: Slowly and firmly push the plunger down
Slovenian: Počasi in močno potisnite bat navzdol
English: Difference in Least Squares Mean (LSM) Change from Baseline Between Treatment Groups in mNIS+7 and Components
Slovenian: Razlika v spremembi od izhodišča srednje vrednosti najmanjših kvadratov (LSM) med zdravljenimi skupinami v mNIS+7 in komponentah
English: Milk transfer of inotersen was low in mice.
Slovenian: Prehajanje inotersena v materino mleko je bilo pri miših majhno.
English: Do not inject into the 3cm area around the belly-button (navel).
Slovenian: Zdravila ne injicirajte v območje 3 cm okoli popka.
English: Tegsedi can lower your body's levels of vitamin A (also called retinol).
Slovenian: Zdravilo Tegsedi lahko zniža ravni vitamina A v telesu (ki se imenuje tudi retinol).
English: Hereditary transthyretin amyloidosis is a genetic disease, which causes build-up of small fibres of a protein called transthyretin in the organs of your body stopping them from working properly.
Slovenian: Dedna transtiretinska amiloidoza je genska bolezen, ki povzroča kopičenje majhnih vlaken beljakovine transtiretin v telesnih organih in s tem onemogoča njihovo pravilno delovanje.
English: Treatment should be initiated by and remain under the supervision of a physician experienced in the treatment of patients with hereditary transthyretin amyloidosis.
Slovenian: Zdravljenje mora uvesti in nadalje nadzorovati zdravnik, ki je izkušen v zdravljenju bolnikov z dedno transtiretinsko amiloidozo.
English: Do not move the plunger.
Slovenian: Ne premikajte bata.
English: Water for injections Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment)
Slovenian: 6.1 Seznam pomožnih snovi voda za injekcije klorovodikova kislina (za prilagoditev vrednosti pH) natrijev hidroksid (za prilagoditev vrednosti pH)
English: If glomerulonephritis is excluded, dosing may be resumed if clinically indicated and following improvement of renal function (see section 4.3).
Slovenian: Ob izključitvi glomerulonefritisa se lahko odmerjanje nadaljuje, če je klinično indicirano in po izboljšanju delovanja ledvic (glejte poglavje 4.3).
English: Doses should be administered once every week.
Slovenian: Odmerke je treba dajati enkrat tedensko.
English: The needle should now be retracted safely inside the pre-filled syringe, and the safety mechanism spring visible on the outside of the plunger.
Slovenian: Na tej točki mora biti igla umaknjena v notranjost napolnjene injekcijske brizge, varnostni mehanizem pa mora biti viden na zunanji strani bata.
English: The selective binding of inotersen to the TTR messenger RNA (mRNA) causes the degradation of both mutant and wild type (normal) TTR mRNA.
Slovenian: Selektivna vezava inotersena na informacijsko RNK (mRNK) transtiretina povzroči degradacijo mutiranega in divjega (normalnega) tipa mRNK za TTR.
English: Mean (SD)
Slovenian: Srednja vrednost (SD)
English: Some patients treated with inotersen have also developed a decline in their kidney function without having had glomerulonephritis.
Slovenian: Pri nekaterih bolnikih, ki so prejemali inotersen, je prišlo tudi do poslabšanja delovanja ledvic, ne da bi se pojavil glomerulonefritis.
English: The most frequently observed events included events associated with injection site reactions (includes injection site pain, erythema, pruritus, swelling, rash, induration, bruising and haemorrhage).
Slovenian: Najpogosteje opaženi neželeni učinki so vključevali učinke, povezane z reakcijami na mestu injiciranja (vključno z bolečinami na mestu injiciranja, eritemom, pruritusom, oteklostjo, izpuščajem, induracijo, podplutbami in krvavitvijo).
English: The primary efficacy endpoints were the change from baseline to Week 66 in the modified Neuropathy Impairment Score + 7 tests (mNIS+7) composite score and in the Norfolk Quality of Life - Diabetic Neuropathy (QoL-DN) questionnaire total score.
Slovenian: Primarna opazovana dogodka učinkovitosti sta bila sprememba od izhodišča do 66. tedna v sestavljenem rezultatu modificiranega rezultata za oceno nevropatske prizadetosti + 7 testov (mNIS + 7) ter v skupnem rezultatu na norfolškem vprašalniku o kakovosti življenja - diabetična nevropatija (Norfolk QoL-DN).
English: A responder was defined as a subject who had a change from baseline that was less than or equal to the threshold value.
Slovenian: Odziven bolnik je bil opredeljen kot preskušanec s spremembo od izhodiščne vrednosti, ki je bila enaka mejni vrednosti ali manjša.
English: Elderly population No overall differences in pharmacokinetics were observed between other adult and elderly patients.
Slovenian: Starejši bolniki Med starejšimi bolniki in drugimi odraslimi niso opazili nobenih splošnih razlik v farmakokinetiki.
English: Tegsedi is a clear, colourless to pale yellow solution (pH 7.5 - 8.8) for injection (injection) in a pre-filled syringe.
Slovenian: Zdravilo Tegsedi je bistra, brezbarvna do bledo rumena raztopina (pH 7,5-8,8) za injiciranje v napolnjeni injekcijski brizgi.
English: No data are available in patients with severe renal impairment.
Slovenian: Podatki o bolnikih s hudo okvaro ledvic niso na voljo.
English: In the pivotal Phase 2/3 study, 30.4% of patients treated with inotersen tested positive for anti-drug antibodies following 15 months of treatment.
Slovenian: faze je bilo 30,4 % bolnikov, zdravljenih z inotersenom, po 15 mesecih zdravljenja pozitivnih na protitelesa proti zdravilu.
English: Subgroup n (Placebo, Inotersen)
Slovenian: Podskupina n (placebo, inotersen)
English: The elimination of inotersen involves both metabolism in tissues and excretion in urine.
Slovenian: Izločanje inotersena poteka s presnovo v tkivih in izločanje z urinom.
English: The changes from baseline in both primary endpoints (mNIS+7 and Norfolk QoL-DN) demonstrated statistically significant benefit in favour of inotersen treatment at Week 66 (Table 4).
Slovenian: Spremembe glede na izhodiščno vrednost v obeh primarnih opazovanih dogodkih (mNIS+7 in Norfolk QoL-DN) so pokazale statistično pomembno korist zdravljenja z inotersenom v 66. tednu (preglednica 4).
English: Primary Endpoint Analysis mNIS+7 and Norfolk QoL-DN
Slovenian: Analiza primarnih opazovanih dogodkov mNIS+7 in Norfolk QoL-DN
English: Women of child-bearing potential have to use effective contraception during treatment with inotersen.
Slovenian: Ženske v rodni dobi morajo med zdravljenjem z inotersenom uporabljati učinkovito kontracepcijo.
English: The MAH shall ensure that in each MS where Tegsedi is marketed, all patients who are expected to been administered the products are provided with a patient alert card (wallet size), aiming at preventing and/or minimising the important identified risks of thrombocytopenia, glomerulonephritis, and the important potential risk of ocular toxicity due to vitamin A deficiency, and reminding patients:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora v vseh državah članicah, v katerih se trži zdravilo Tegsedi, zagotoviti, da vsi bolniki, pri katerih je mogoče pričakovati, da bodo prejeli to zdravilo, prejmejo opozorilno kartico za bolnika (v velikosti denarnice), katere namen je preprečevanje in/ali zmanjševanje pomembnih identificiranih tveganj za trombocitopenijo, glomerulonefritis in pomembnega morebitnega tveganja za očesno toksičnost zaradi pomanjkanja vitamina A, ter opozoriti bolnike:
English: When the plunger comes to a stop, your injection is complete.
Slovenian: Ko se bat ustavi, je injiciranje končano.
English: The pre-filled syringe should be allowed to reach room temperature prior to injection.
Slovenian: Napolnjena injekcijska brizga se mora pred injiciranjem segreti na sobno temperaturo.
English: Because of the risk of glomerulonephritis and possible renal function decline, UPCR and eGFR should be monitored during treatment with inotersen (see section 4.4).
Slovenian: Zaradi tveganja za glomerulonefritis in morebitno poslabšanje delovanja ledvic je treba med zdravljenjem z inotersenom spremljati UPCR in eGFR (glejte poglavje 4.4).
English: Thus, pharmacokinetics should not be altered in mild to moderate hepatic impairment.
Slovenian: Zato se farmakokinetika pri blagi do zmerni okvari jeter ne bi smela spremeniti.
English: If injected in the upper arm, the injection should be administered by another person.
Slovenian: Pri injiciranju v nadlaket mora injekcijo dati druga oseba.