FrancophonIA/ELRC3.0 huggingface dataset:
English: The concurrent administration of Kineret and etanercept or other TNF-α antagonists is not recommended (see section 4.5).
Slovenian: Sočasna uporaba zdravila Kineret in etanercepta ali drugih antagonistov TNF-α ni priporočljiva (glejte poglavje 4.5).
English: Macrophage activation syndrome (MAS) is a known, life-threatening disorder that may develop in patients with Still's disease.
Slovenian: Sinrom aktivacije makrofagov (MAS-macrophage activation syndrome) je znana življenjsko nevarno stanje, ki se lahko razvije pri bolnikih s Stillovo boleznijo.
English: Cutaneous, Articular Syndrome (CINCA) - Muckle-Wells Syndrome (MWS) - Familial Cold Autoinflammatory Syndrome (FCAS)
Slovenian: (CINCA - Chronic Infantile Neurological, Cutaneous, Articular Syndrome) - Muckle-Wellsov sindrom (MWS) - družinski avtoinflamatorni sindrom zaradi mraza (FCAS - Familial Cold Autoinflammatory Syndrome)
English: Systemically, IL-1 is known to cause the hypothalamic fever response and promote hyperalgesia.
Slovenian: Znano je, da IL-1 sistemsko povzroči hipotalamični odziv z zvišano telesno temperaturo in spodbudi hiperalgezijo.
English: - Serious infections such as pneumonia (a chest infection) or infections of the skin.
Slovenian: - resne okužbe, na primer pljučnica (okužba v prsnem košu) ali okužbe kože;
English: The efficacy and safety of Kineret in patients with AST/ALT ≥ 1.5 x upper level of normal have not been evaluated.
Slovenian: Učinkovitost in varnost zdravila Kineret pri bolnikih z vrednostjo AST/ALT ≥1,5 krat višjo od najvišje normalne vrednosti nista bili ocenjeni.
English: This would be clinically relevant for CYP450 substrates with a narrow therapeutic index (e.g. warfarin and phenytoin).
Slovenian: CYP450 z ozkim terapevtskim indeksom (npr. varfarin in fenitoin).
English: Hold the syringe barrel and gently remove the cover from the needle without twisting.
Slovenian: Primite telo brizge in previdno odstranite pokrovček z igle, ne da bi ga vrteli.
English: In 15 SJIA patients followed for up to 1.5 years, one patient developed a serious hepatitis in connection with a cytomegalovirus infection.
Slovenian: Pri 15 bolnikih s SJIA, ki so jih spremljali do 1,5 leta, se je pri enem bolniku razvila resna oblika hepatitisa v povezavi s citomegalovirusno okužbo.
English: If you develop signs of an infection or worsening of your Still's disease symptoms you should contact your health care provider as soon as possible.
Slovenian: Če se pojavijo znaki okužbe ali poslabšanja simptomov Stillove bolezni, se morate čim prej posvetovati z zdravnikom.
English: Additional published data in Still's disease indicate that Kineret induces a rapid resolution of systemic features such as fever, rash, and elevation of acute phase reactants.
Slovenian: Dodatni objavljeni podatki o Stillovi bolezni kažejo, da zdravilo Kineret povzroči hitro rešitev sistemskih težav, kot so zvišana telesna temperatura, izpuščaj in povišanje reaktantov akutne faze.
English: In 43 CAPS patients followed for up to 5 years neutropenia was reported in 2 patients.
Slovenian: Od 43 bolnikov s CAPS, ki so jih spremljali do 5 let, so o nevtropeniji poročali pri 2 bolnikih.
English: Still's disease - Patients with Still's disease may develop a condition called macrophage activation syndrome (MAS), which can be life-threatening.
Slovenian: Stillova bolezen - Pri bolnikih s Stillovo boleznijo se lahko razvije bolezen, ki se imenuje sindrom aktivacije makrofagov (MAS), ki je lahko smrtno nevarna.
English: Kineret has not been tested in pregnant women.
Slovenian: Pri nosečnicah zdravila Kineret niso preizkusili.
English: If you use more Kineret than you should
Slovenian: Če ste uporabili večji odmerek zdravila Kineret, kot bi smeli
English: For CAPS, Kineret is used to treat the signs and symptoms of inflammation associated with the disease such as rash, joint pain, fever, headache and fatigue in adults and children (age 8 months and older).
Slovenian: Pri CAPS se zdravilo Kineret uporablja za zdravljenje znakov in simptomov vnetja, povezanega z boleznimi, kot so izpuščaji, bolečina v sklepih, vročina, glavobol in utrujenost pri odraslih in otrocih (starih 8 mesecev in več).
English: During post-marketing use isolated case reports indicating non-infectious hepatitis have been received.
Slovenian: V času uporabe po začetku trženja so se pojavili posamezni primeri, ki so kazali na neinfektivni hepatitis.
English: Kineret is injected just under the skin.
Slovenian: Zdravilo Kineret se injicira tik pod kožo.
English: Adult
Slovenian: Odrasla oseba
English: - Thrombocytopenia (low level of blood platelets).
Slovenian: - trombocitopenija (nizka raven trombocitov v krvi).
English: Kineret is indicated in adults for the treatment of the signs and symptoms of RA in combination with methotrexate, with an inadequate response to methotrexate alone.
Slovenian: Zdravilo Kineret je indicirano pri odraslih za zdravljenje znakov in simptomov RA v kombinaciji z metotreksatom pri bolnikih z nezadostnim odzivom na metotreksat sam.
English: The estimated anakinra clearance increased with increasing creatinine clearance and body weight.
Slovenian: Ocenjeni očistek anakinre se je večal z rastočim očistkom kreatinina in s telesno maso.
English: The pre-filled syringe is for single use only.
Slovenian: Napolnjena injekcijska brizga je samo za enkratno uporabo.
English: Neutropenia (ANC < 1.5 x 109/l) was reported in 2.4% patients receiving Kineret compared with 0.4% of placebo patients.
Slovenian: O nevtropeniji (ANC < 1,5 x 109/l) so poročali pri 2,4 % bolnikov, ki so prejemali zdravilo Kineret, v primerjavi z 0,4 % pri bolnikih s placebom.
English: The development of ISRs in patients who had not previously experienced ISRs was uncommon after the first month of therapy.
Slovenian: Pri bolnikih, ki prej niso imeli ISR, se je ISR po prvem mesecu zdravljenja razvila le izjemoma.
English: The safety and efficacy of Kineret have been demonstrated in CAPS patients with varying degrees of disease severity.
Slovenian: Varnost in učinkovitost zdravila Kineret so dokazali pri bolnikih s CAPS z različnimi stopnjami izraženosti bolezni.
English: For RA, Kineret is used to treat the signs and symptoms of the disease in adults (age 18 years and over) in combination with another medicine called methotrexate.
Slovenian: Pri RA se zdravilo Kineret uporablja za zdravljenje znakov in simptomov revmatoidnega artritisa pri odraslih (starih 18 let in več) v kombinaciji s še enim zdravilom, ki se imenuje metotreksat.
English: At the same time point, 7 of 12 in the Kineret treated group were classified as ACRpedi50 and 5 of 12 as ACRpedi70 responders compared to none in the placebo group.
Slovenian: Na isti časovni točki je imelo 7 od 12 bolnikov v skupini, zdravljeni z zdravilom Kineret, odziv ACRpedi50 in 5 od 12 odziv ACRpedi70, v primerjavi z nobenim bolnikom v skupini, zdravljeni s placebom.
English: Neutrophil decreases occurred more frequently in patients receiving Kineret compared with placebo.
Slovenian: Nevtrofilci so se znižali pogosteje pri bolnikih, ki so dobivali zdravilo Kineret, kot pri tistih, ki so prejemali placebo.
English: The infections observed consisted primarily of bacterial events such as cellulitis, pneumonia, and bone and joint infections.
Slovenian: Zabeležene okužbe so obsegale predvsem bakterijske, npr. flegmono, pljučnico ter okužbe kosti in sklepov.
English: - In rare cases patients with Still's disease, mainly children, may develop lung disease, also during Kineret treatment.
Slovenian: - V redkih primerih se lahko pri bolnikih s Stillovo boleznijo, predvsem pri otrocih, pojavi pljučna bolezen, tudi med zdravljenjem z zdravilom Kineret.
English: • the upper outer areas of the buttocks; and
Slovenian: • zgornji zunanji del zadnjice in
English: In studies of sepsis, 1,015 patients received Kineret at doses up to 2 mg/kg/hour i.v.
Slovenian: V študijah sepse je 1015 bolnikov dobivalo zdravilo Kineret v odmerkih do 2 mg/kg/uro i.v.
English: CAPS: Adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above
Slovenian: CAPS: Odrasli, mladostniki, otroci in dojenčki, stari 8 mesecev in več, s telesno maso 10 kg ali več Začetni odmerek
English: Pack sizes of 1, 7 or 28 (multipack containing 4 packs of 7 pre-filled syringes) pre-filled syringes.
Slovenian: Pakiranja po 1, 7 ali 28 (skupno pakiranje, ki vsebuje 4 ali 7 napolnjenih injekcijskih brizg) napolnjenih injekcijskih brizg.
English: These were typically characterised by 1 or more of the following: erythaema, ecchymosis,
Slovenian: Običajno je bilo zanje značilno eno ali več od naslednjega: eritem, ekhimoza, vnetje in bolečina.
English: There are limited amount of data from the use of anakinra in pregnant women.
Slovenian: Podatki o uporabi anakinre pri nosečnicah so omejeni.
English: What Kineret looks like and contents of the pack
Slovenian: Izgled zdravila Kineret in vsebina pakiranja
English: For a small number of patients with asthma, the incidence of serious infection was higher in Kineret-treated patients (4.5%) vs. placebo-treated patients (0%), these infections were mainly related to the respiratory tract.
Slovenian: Pri majhnem številu bolnikov z astmo je bila incidenca resnih okužb večja pri bolnikih, ki so dobivali zdravilo Kineret (4,5%), kot pri tistih, ki so dobivali placebo (0 %), te okužbe pa so se nanašale v glavnem na dihalne poti.
English: Hepatic events in patients with Still's disease predominantly occur during the first month of Kineret treatment.
Slovenian: Jetrni zapleti pri bolnikih s Stillovo boleznijo se pretežno pojavijo v prvem mesecu zdravljenja z zdravilom Kineret.
English: There are no indications from post-marketing experience that types and severity of infections in patients with Still's disease differ from those in RA or CAPS patients.
Slovenian: Iz izkušenj med uporabo po začetku trženja ni indikacij, da bi bile vrste in jakost okužb pri bolnikih s Stillovo boleznijo drugačne kot pri bolnikih z RA ali CAPS.
English: If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.
Slovenian: Če imate kakršne koli težave, brez obotavljanja prosite za pomoč in nasvet zdravnika ali medicinsko sestro.
English: Prior to launch of the new indication Still's disease for Kineret in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme,
Slovenian: Pred uvedbo nove indikacije za zdravilo Kineret za Stillovo bolezen v vsaki državi članici mora imetnik dovoljenja za promet z zdravilom (MAH) z nacionalnim pristojnim organom uskladiti vsebino in obliko izobraževalnega programa, vključno s sredstvi obveščanja, načini razdeljevanja in vsemi drugimi vidiki programa.
English: • The prescribed dose of Kineret
Slovenian: • predpisani odmerek zdravila Kineret,
English: The mean plasma clearance of Kineret in subjects with mild (creatinine clearance 50-80 ml / min) and moderate (creatinine clearance 30-49 ml/min) renal insufficiency was reduced by 16% and 50%, respectively.
Slovenian: Srednji plazemski očistek zdravila Kineret pri osebah z blago (očistek kreatinina 50-80 ml/min) in zmerno ledvično insuficienco (očistek kreatinina 30-49 ml/min) je bil zmanjšan za 16 % oziroma
English: There are no indications either from this study or from post-marketing adverse reaction reports that the overall safety profile in patients with CAPS or Still's disease is different from that in patients with RA, with the exception of the risk for development of MAS in patients with Still's disease.
Slovenian: Glede na to študijo ali poročila o neželenih učinkih med uporabo po začetku trženja ni nobenih znakov, da je splošni varnostni profil pri bolnikih s CAPS ali Stillovo boleznijo drugačen kot pri bolnikih z RA, z izjemo tveganja za razvoj MAS pri bolnikih s Stillovo boleznijo.
English: Each graduated pre-filled syringe contains 100 mg of anakinra* per 0.67 ml (150 mg/ml).
Slovenian: Ena odmerna napolnjena injekcijska brizga vsebuje 100 mg anakinre* na 0,67 ml (150 mg/ml).
English: You must not be given live vaccines while being treated with
Slovenian: Živih cepiv zato ne smete uporabljati sočasno z zdravilom
English: In 43 CAPS patients followed for up to 5 years no patient permanently or temporarily discontinued Kineret treatment due to injection site reactions.
Slovenian: Od 43 bolnikov s CAPS, ki so jih spremljali do 5 let, ni bilo pri nobenem bolniku trajno ali začasno prekinjeno zdravljenje z zdravilom Kineret zaradi reakcij na mestu injiciranja.
English: In severe renal insufficiency and end stage renal disease (creatinine clearance < 30 ml/min), mean plasma clearance declined by 70% and 75%, respectively.
Slovenian: Pri hudi ledvični insuficienci in končni ledvični odpovedi (očistek kreatinina < 30 ml/min) se je srednji plazemski očistek zmanjšal za 70 % oz. 75 %.
English: The subject incidence of serious adverse reactions in RA studies at the recommended dose of Kineret (100 mg/day) was comparable with placebo (7.1% compared with 6.5% in the placebo group).
Slovenian: Incidenca resnih neželenih učinkov v študijah RA pri priporočenem odmerku zdravila Kineret (100 mg/dan) je bila primerljiva s placebom (7,1 % v primerjavi s 6,5 % v skupini s placebom).
English: Data from mice over expressing IL-1ra and IL-1ra mutant knock-out mice, did not indicate an increased risk of tumour development.
Slovenian: Podatki, pridobljeni na transgenih miših s prekomerno ekspresijo IL-1ra in tistih z mutiranim IL-1ra niso pokazali zvečane nevarnosti za razvoj tumorjev.
English: • the top of the thighs
Slovenian: • zgornji del stegen
English: CAPS: Data in elderly patients are limited.
Slovenian: CAPS: Podatki o starejših bolnikih so omejeni.
English: Kineret contains the active substance anakinra.
Slovenian: Zdravilo Kineret vsebuje učinkovino anakinra.
English: It is unknown whether anakinra/metabolites are excreted in human milk.
Slovenian: Ni znano, ali se anakinra/presnovki izločajo v materino mleko.
English: Possible side effects are similar regardless if you are treated with Kineret for RA, CAPS or Still's disease.
Slovenian: Možni neželeni učinki so podobni, ne glede na to, ali se zdravite z zdravilom Kineret zaradi RA, CAPS ali Stillove bolezni.
English: Allergic reactions, including anaphylactic reactions and angioedema have been reported uncommonly.
Slovenian: Občasno so poročali o alergijskih reakcijah, vključno z anafilaktičnimi reakcijami in angioedemom.
English: In placebo-controlled studies in RA patients, the most frequently reported adverse reactions with Kineret were injection site reactions (ISRs), which were mild to moderate in the majority of patients.
Slovenian: V s placebom kontroliranih študijah pri bolnikih z RA so bili neželeni učinki pri zdravilu Kineret, o katerih so najpogosteje poročali, reakcije na mestu injiciranja (ISR - „injection site reaction“), ki so bile pri večini bolnikov blage do zmerne.
English: Undesirable Effect
Slovenian: Možni neželeni učinki
English: In Kineret treated CAPS patients, there is a risk for disease flares when discontinuing Kineret treatment.
Slovenian: Pri bolnikih s CAPS, zdravljenih z zdravilom Kineret, obstaja tveganje za izbruh bolezni po prekinitvi zdravljenja s tem zdravilom.
English: This medicine contains less than 1 mmol sodium (23 mg) per 100 mg dose, that is to say essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 100 mg, kar v bistvu pomeni „brez natrija“.
English: Kineret is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of Still's disease, including Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still's Disease (AOSD), with active systemic features of moderate to high disease activity, or in patients with continued disease activity after treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids.
Slovenian: Zdravilo Kineret je indicirano pri odraslih, mladostnikih, otrocih in dojenčkih, starih 8 mesecev in več, s telesno maso 10 kg ali več, za zdravljenje Stillove bolezni, vključno s sistemskim juvenilnim idiopatskim artritisom (SJIA - Systemic Juvenile Idiopathic Arthritis) in Stillovo boleznijo z začetkom v odrasli dobi (AOSD - Adult-Onset Still's Disease), z aktivnimi sistemskimi značilnostmi zmerne do visoke aktivnosti bolezni, ali pri bolnikih z neprekinjeno aktivnostjo bolezni po zdravljenju z nesteroidnimi protivnetnimi zdravili (NSAID) ali glukokortikoidi.
English: Concurrent Kineret and etanercept treatment has not demonstrated increased clinical benefit.
Slovenian: Sočasno zdravljenje z zdravilom Kineret in etanerceptom ni pokazalo zvečane klinične koristnosti.
English: As a precautionary measure, it is preferable to avoid the use of anakinra during pregnancy and in woman of childbearing potential not using contraception.
Slovenian: Iz previdnostnih razlogov se je med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije, uporabi anakinre bolje izogibati.
English: What should you do before you give yourself or your child a subcutaneous injection of Kineret?
Slovenian: Kaj morate narediti, preden daste podkožno injekcijo zdravila Kineret sebi ali svojemu otroku?
English: No data are available on either the effects of live vaccination or on the secondary transmission of infection by live vaccines in patients receiving Kineret.
Slovenian: O učinkih živih cepiv in o sekundarnem prenosu okužbe z živimi cepivi pri bolnikih, ki so dobivali zdravilo Kineret, ni nobenih podatkov.
English: The safety and efficacy of Kineret treatment in patients with chronic and serious infections have not been evaluated.
Slovenian: Varnosti in učinkovitosti zdravila Kineret pri bolnikih s kroničnimi in resnimi okužbami niso ovrednotili.
English: Overall, the efficacy and safety profile of Kineret is comparable in adult and paediatric patients with CAPS or Still's disease.
Slovenian: Pediatrična populacija V celoti sta učinkovitost in varnostni profil zdravila Kineret primerljiva pri odraslih in pediatričnih bolnikih s CAPS ali Stillovo boleznijo.
English: Solution for injection in pre-filled syringe 7 GRADUATED pre-filled syringes This box containing 7 pre-filled syringes is part of a 28-multipack.
Slovenian: raztopina za injiciranje v napolnjeni injekcijski brizgi 7 ODMERNIH napolnjenih injekcijskih brizg Ta škatla s 7 napolnjenimi injekcijskimi brizgami je del pakiranja po 28.
English: The majority of patients have been treated for Still's disease or have had predisposing factors, e.g. a history of transaminase elevations.
Slovenian: Večina bolnikov je bila zdravljena za Stillovo bolezen ali je imela predispozicijske dejavnike, npr.
English: The safety and efficacy of Kineret in patients with neutropenia have not been evaluated.
Slovenian: Varnosti in učinkovitosti zdravila Kineret pri bolnikih z nevtropenijo niso ovrednotili.
English: Kineret treatment must not be initiated in patients with neutropenia (ANC <1.5 x 109/l) (see section 4.4).
Slovenian: Zdravila Kineret se ne sme uvesti pri bolnikih z nevtropenijo (ANC < 1,5 x 109/l) (glejte poglavje 4.4).
English: Change the place that you inject each time so you don't become sore in one area.
Slovenian: Mesto injiciranja vsakokrat zamenjajte, tako da se en predel ne bo razbolel.
English: After a 1-month blinded phase, 8 of 12 patients in the Kineret treated group were identified as modified ACRpedi30 responders compared to 1 of 12 in the placebo group.
Slovenian: Po 1-mesečni slepi fazi je bilo ugotovljeno, da je imelo spremenjeni odziv ACRpedi30 8 od 12 bolnikov v skupini, ki se je zdravila z zdravilom Kineret, v primerjavi z 1 od 12 bolnikov v skupini, zdravljeni s placebom.
English: CAPS: Posology and administration in children and infants aged 8 months and older with a body weight of 10 kg or above are the same as for adult CAPS patients, based on body weight.
Slovenian: CAPS: Odmerjanje in dajanje otrokom in dojenčkom, starim 8 mesecev in več s telesno maso 10 kg ali več je enako kot pri odraslih bolnikih s CAPS in temelji na telesni masi.
English: Hepatic events during post-marketing use have mainly been reported in patients that have been treated for Still's disease and in patients with predisposing factors, e.g. a history of transaminase elevations before start of Kineret treatment.
Slovenian: Primeri jetrnih zapletov v času uporabe po začetku trženja so bili opisani pri bolnikih, ki so se zdravili za Stillovo bolezen, in pri bolnikih s predispozicijskimi dejavniki, npr. z anamnezo zvišanih vrednosti transaminaze pred začetkom zdravljenja z zdravilom Kineret.
English: In patients who become neutropenic (ANC < 1.5 x 109/l) the ANC should be monitored closely and Kineret treatment should be discontinued.
Slovenian: Pri bolnikih, ki postanejo nevtropenični (ANC < 1,5 x 109/l), je treba skrbno spremljati ANC, zdravljenje z zdravilom Kineret pa je treba prekiniti.
English: Solution for injection in pre-filled syringe 1 GRADUATED pre-filled syringe 7 GRADUATED pre-filled syringes Multipack: 28 (4 x 7) GRADUATED pre-filled syringes
Slovenian: raztopina za injiciranje v napolnjeni injekcijski brizgi 1 ODMERNA napolnjena injekcijska brizga 7 ODMERNIH napolnjenih injekcijskih brizg Skupno pakiranje: 28 (4 x 7) ODMERNIH napolnjenih injekcijskih brizg
English: In patients with severe renal impairment (CLcr <30 ml/min) or end stage renal disease, including dialysis, administration of the prescribed dose of Kineret every other day should be considered.
Slovenian: Pri bolnikih s hudo ledvično okvaro (CLcr < 30 ml/min) ali končno ledvično odpovedjo, ki vključuje dializo, je treba razmisliti o dajanju predpisanega odmerka zdravila Kineret vsak drugi dan.
English: Kineret treatment significantly decreases the manifestations of CAPS, including a reduction in frequently occurring symptoms as fever, rash, joint pain, headache, fatigue, and eye redness.
Slovenian: Zdravljenje z zdravilom Kineret znatno zmanjša pojav znakov CAPS, vključno z zmanjšanjem simptomov, ki se pogosto pojavljajo, kot so vročina, izpuščaji, bolečina v sklepih, glavobol, utrujenost in rdeče oči.
English: X-ray examinations have been undertaken in one clinical study with anakinra.
Slovenian: V eni klinični študiji z anakinro so opravili rentgenske preiskave.
English: The recommended dose of Kineret is 100 mg administered once a day by subcutaneous injection.
Slovenian: Priporočeni odmerek zdravila Kineret je 100 mg, enkrat na dan s subkutanim injiciranjem.
English: Symptoms might be persistent high fever, shivers, cough, headache, and redness and tenderness of the skin.
Slovenian: Simptomi so lahko vztrajna zvišana telesna temperatura, mrzlica, kašelj, glavobol ter rdečina in občutljivost kože.
English: The graduated pre-filled syringe allows for doses between 20 and 100 mg. As the minimum dose is 20 mg the syringe is not suitable for paediatric patients with a body weight below 10 kg.
Slovenian: Ker je najmanjši odmerek 20 mg, injekcijska brizga ni primerna za pediatrične bolnike s telesno maso pod 10 kg.
English: This is called a subcutaneous injection.
Slovenian: Takšno injiciranje imenujemo podkožno (subkutano).
English: Still's disease: Data in elderly patients are limited.
Slovenian: Stillova bolezen: Podatki pri starejših bolnikih so omejeni.
English: The median steady-state dose-normalized anakinra concentration in SJIA patients over 28 weeks was comparable to that observed in RA patients.
Slovenian: Mediana koncentracija anakinre v stanju dinamičnega ravnovesja z normalizacijo odmerka pri bolnikih s SJIA v 28 tednu je bila primerljiva tisti pri bolnikih z RA.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 100 mg dose, that is to say essentially ‘sodium-free'.
Slovenian: Vsebnost natrija To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 100 mg, kar v bistvu pomeni „brez natrija“.
English: These elevations have not been associated with signs or symptoms of hepatocellular damage, except for one patient with SJIA that developed a serious hepatitis in connection with a cytomegalovirus infection.
Slovenian: Ta zvišanja niso bila povezana z znaki ali simptomi hepatoceličnih okvar, razen pri enem bolniku s SJIA, pri katerem se je razvila resna oblika hepatitisa v povezavi s citomegalovirusno okužbo.