natgillin/translations-raw huggingface dataset:
Some of these side effects, such as reddening of the face or body (flushing), diarrhoea, stomach problems and nausea usually improve as you continue treatment. 
Nekateri od teh neželenih učinkov, kot so npr. pordelost obraza ali telesa (zardevanje), driska, želodčne težave in slabost, se običajno izboljšajo v nadaljevanju zdravljenja.
The efficacy of oral contraceptives may be reduced and the use of an alternative barrier contraceptive method is recommended to prevent possible failure of contraception (see the prescribing information of the oral contraceptive). 
Učinkovitost peroralnih kontracepcijskih sredstev se lahko zmanjša, zato je priporočljivo uporabljati alternativne pregradne kontracepcijske metode, ki preprečuje morebitno odpoved kontracepcije (glejte navodila za predpisovanje peroralnega kontracepcijskega sredstva).
Proteinuria* Renal failure* Fanconi syndrome* 
Bolezni sečil proteinurija* odpoved ledvic* Fanconijev sindrom*
Rare side effects (may affect up to 1 in 1,000 people): - allergic skin reaction 
Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): - alergične reakcije na koži
What you need to know before you take Skilarence 
Kaj morate vedeti, preden boste vzeli zdravilo Skilarence
In particular, in the clinical study there was a slight decrease in mean lymphocyte counts starting between weeks 3 and 5 and reaching a maximum in week 12 where approximately one third of patients had lymphocyte values below 1.0x10 
Še zlasti so v klinični študiji opazili rahlo zmanjšanje povprečnega števila limfocitov, ki se je začelo med tretjim in petim tednom ter doseglo vrh v 12. tednu, ko je imela približno tretjina bolnikov vrednosti limfocitov pod 1,0 x 10
The safety and efficacy of Skilarence was assessed in one double-blind, 3-arm, placebo- and active comparator-controlled Phase III study (1102) in patients with moderate to severe plaque psoriasis (Study 1102). 
Varnost in učinkovitost zdravila Skilarence so ocenjevali v eni dvojno slepi študiji III. faze (1102) s tremi skupinami, kontrolirani s placebom in aktivnim primerjalnim zdravilom, opravljeni pri bolnikih z zmerno do hudo psoriazo v plakih (Študija 1102).
Symptoms include fever, pain, aching muscles, headache, loss of appetite and a general feeling of weakness. 
Simptomi vključujejo povišano telesno temperaturo, bolečine, boleče mišice, glavobol, izgubo teka in splošen občutek šibkosti.
Further metabolism occurs through oxidation via the tricarboxylic acid cycle forming carbon dioxide and water. 
Nadaljnja presnova poteka z oksidacijo prek cikla trikarboksilne kisline, pri čemer nastajata ogljikov dioksid in voda.
In the clinical study a total of 20.8% of patients receiving Skilarence experienced flushing, which was mild in the majority of cases (see section 4.4). 
V klinični študiji se je pri skupno 20,8 % bolnikov, ki so prejemali zdravilo Skilarence, pojavilo vročinsko oblivanje, ki je bilo v večini primerov blago (glejte poglavje 4.4).
If you are affected, be careful when driving or using machines. 
Če se ti učinki pojavijo pri vas, bodite pri upravljanju vozil in strojev previdni.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'. 
Zdravilo Skilarence vsebuje natrij To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na tableto, kar v bistvu pomeni 'brez natrija'.
After clinically relevant improvement of the skin lesions has been achieved, consideration should be given to gradual reduction of the daily dose of Skilarence to the maintenance dose required by the individual. 
Po klinično pomembnem izboljšanju kožnih lezij je treba razmisliti o postopnem zmanjšanju dnevnega odmerka zdravila Skilarence do vzdrževalnega odmerka, ki ga potrebuje posameznik.
Patients began treatment with tablets containing 30 mg/day dimethyl fumarate or placebo, titrating up to a maximum of 720 mg/day in both active treatment arms as described in section 4.2. 
Bolniki so pričeli zdravljenje s tabletami, ki so vsebovale 30 mg/dan dimetilfumarata ali placebo, s titracijo do največ 720 mg/dan v obeh skupinah z aktivnim zdravljenjem, kot je opisano v poglavju 4.2.
The most serious side effects that may occur with Skilarence are allergic or hypersensitivity reactions; kidney failure or a kidney disease called Fanconi syndrome; or a severe brain infection called progressive multifocal leukoencephalopathy (PML). 
Najresnejši neželeni učinki, ki se lahko pojavijo ob zdravljenju z zdravilom Skilarence, so alergijske ali preobčutljivostne reakcije; odpoved ledvic ali bolezen ledvic, imenovana Fanconijev sindrom, ali pa huda okužba možganov, imenovana progresivna multifokalna levkoencefalopatija (PML).
Based on available data suggesting that fumaric acid esters may activate cellular pathways related to the development of renal tumours, a potential tumorigenic activity of exogenously administered dimethyl fumarate on the kidneys cannot be excluded. 
Na podlagi razpoložljivih podatkov, ki kažejo, da lahko estri fumarne kisline aktivirajo celične poti, povezane z razvojem ledvičnih tumorjev, potenciala za tumorogeno aktivnost eksogeno danega dimetilfumarata na ledvice ni mogoče izključiti.
Pack sizes: 40, 70, 90, 100, 120, 180, 200, 240, 300, 360 and 400 gastro-resistant tablets. 
Velikosti pakiranj: 40, 70, 90, 100, 120, 180, 200, 240, 300, 360 in 400 gastrorezistentnih tablet.
Prior to initiating treatment with Skilarence, a current complete blood count (including differential blood count and platelet count) should be available. 
Pred uvedbo zdravljenja z zdravilom Skilarence mora biti na voljo trenutna celotna krvna slika (vključno z diferencialno krvno sliko in številom trombocitov).
Patients developing lymphopenia should be monitored after stopping treatment until their lymphocyte count has returned to the normal range (see section 4.8). 
Bolnike, pri katerih se razvije limfopenija, je treba po končanem zdravljenju spremljati, dokler se njihovo število limfocitov ne vrne v običajen razpon (glejte poglavje 4.8).
Skilarence tablets must be swallowed whole with fluid during or immediately after a meal. 
Tablete zdravila Skilarence je treba pogoltniti cele s tekočino med jedjo ali takoj po jedi.
It is unknown whether dimethyl fumarate or its metabolites are excreted in human milk. 
Ni znano, ali se dimetilfumarat ali njegovi presnovki izločajo v materino mleko.
3/279 (1.1%) of the patients started on Skilarence. 
9/l, kar predstavlja 3/279 (1,1 %) bolnike, pri katerih je bilo uvedeno zdravljenje z zdravilom Skilarence.
• The guide for healthcare professionals shall contain the following key elements: o Relevant information on PML (e.g. seriousness, severity, frequency, time to onset, reversibility of the AE as applicable) o Details of the population at higher risk for PML o Details on how to minimise the risk of PML through appropriate monitoring and management, including laboratory monitoring of lymphocyte and leukocyte prior to and during treatment, and criteria for treatment discontinuation o Key messages to convey in counselling of patients 
• Vodnik za zdravstvene delavce mora vsebovati naslednje ključne elemente: o Pomembne informacije o PML (npr. resnost, izraženost, pogostnost, čas do nastopa, reverzibilnost neželenega učinka, kot je ustrezno) o Podrobnosti o populaciji, pri kateri je tveganje za PML večje o Podrobnosti o možnosti zmanjševanja tveganja za PML z ustreznim spremljanjem in obvladovanjem, vključno z laboratorijskim spremljanjem števila limfocitov in levkocitov pred zdravljenjem in med njim, ter kriteriji za prekinitev zdravljenja o Ključna sporočila, ki jih je treba posredovati bolnikom v okviru svetovanja
These medicines taken together with Skilarence could increase the risk of side effects on your kidneys. 
Jemanje teh zdravil skupaj z zdravilom Skilarence bi lahko povečalo tveganje za pojav stranskih učinkov na vaše ledvice.
Vaccination during treatment with Skilarence has not been studied. 
Cepljenja med zdravljenjem z zdravilom Skilarence niso preučevali.
The anti-inflammatory and immunomodulating effects of dimethyl fumarate and its metabolite monomethyl fumarate are not fully elucidated but are thought to be mainly due to the interaction with the intracellular reduced glutathione of cells directly involved in the pathogenesis of psoriasis. 
Protivnetni in imunomodulirajoči učinki dimetilfumarata in njegovega presnovka monometilfumarata niso v celoti pojasnjeni, predpostavljajo pa, da do njih prihaja v glavnem zaradi medsebojnega delovanja z medcelično znižanim glutationom celic, ki so neposredno vključene v patogenezo psoriaze.
Patients should be made aware that they are likely to experience flushing in the first few weeks of taking Skilarence (see section 4.8). 
Bolnike je treba opozoriti, da obstaja velika verjetnost vročinskega oblivanja v prvih tednih jemanja zdravila Skilarence (glejte poglavje 4.8).
Do not take Skilarence - if you are allergic to dimethyl fumarate or any of the other ingredients of this medicine (listed in section 6) - if you have severe problems with your stomach or intestines - if you have severe liver or kidney problems - if you are pregnant or breast-feeding 
Ne jemljite zdravila Skilarence - če ste alergični na dimetilfumarat ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če imate hude težave z želodcem ali prebavili;
The tablets are packed in PVC/PVDC-aluminium blisters. 
Tablete so pakirane v pretisne omote iz PVC/PVDC-aluminija.
At week 16, patients treated with Skilarence had a lower mean DLQI compared to placebo (5.4 vs 8.8). 
V 16. tednu so imeli bolniki, zdravljeni z zdravilom Skilarence, v primerjavi s placebom nižji povprečni DLQI (5,4 v primerjavi z 8,8).
Skilarence 30 mg is available in packs containing 42, 70 and 210 gastro-resistant tablets. 
Zdravilo Skilarence 30 mg je na voljo v pakiranjih, ki vsebujejo 42, 70 in 210 gastrorezistentnih tablet.
Further studies have shown that dimethyl fumarate (and to a lesser extent monomethyl fumarate) reacts partially with reduced glutathione forming a glutathioneadduct. 
Dodatne študije so pokazale, da dimetilfumarat (in v manjši meri monometilfumarat) deloma reagira z znižanim glutationom in tvori adukt glutationa.
Skilarence is a medicine that contains the active substance dimethyl fumarate. 
Skilarence je zdravilo, ki vsebuje učinkovino dimetilfumarat.
- Pregnancy and breast-feeding. 
− Nosečnost in dojenje.
Skilarence may reduce the number of your white blood cells. 
Zdravilo Skilarence lahko zmanjša število belih krvničk pri vas.
The main activity of dimethyl fumarate and monomethyl fumarate is considered to be immunomodulatory, resulting in a shift in T helper cells (Th) from the Th1 and Th17 profile to a Th2 phenotype. 
Glavna aktivnost dimetilfumarata in monometilfumarata naj bi bila imunomodulacijska, ki povzroča premik T-celic pomagalk (Th) s profila Th1 in Th17 v fenotip Th2.
For patients with pre-existing infections of clinical relevance, the physician should decide if treatment with Skilarence should only be initiated once the infection has resolved. 
Pri bolnikih z obstoječimi klinično pomembnimi okužbami se mora zdravnik odločiti, ali se lahko zdravljenje z zdravilom Skilarence uvede šele, ko okužba mine.
If you have a serious infection, either before starting treatment with Skilarence or during treatment, your doctor may advise you not to take Skilarence until the infection has resolved. 
Če imate resno okužbo, ki se pojavi pred uvedbo zdravljenja z zdravilom Skilarence ali med njim, vam bo zdravnik morda svetoval, da zdravila Skilarence ne jemljete, dokler okužba ne izzveni.
Your dose will be increased every week as shown in the table below (switching to 120 mg Skilarence tablets from week 4 onwards). 
Vaš odmerek bo vsak teden povečal, kot je prikazano v spodnji preglednici (prehod na 120 mg tablete zdravila Skilarence od 4. tedna dalje).
704 patients were randomised to receive Skilarence, an active comparator (Fumaderm, a combination product with the same content of dimethyl fumarate plus 3 monoethyl fumarate salts) and placebo in a ratio of 2:2:1. 
704 bolnikov je bilo randomiziranih za prejemanje zdravila Skilarence, aktivne primerjave (zdravilo Fumaderm, kombinirano zdravilo z enako vsebnostjo dimetilfumarata in s 3 monometilnimi fumaratnimi solmi) in placeba, v razmerju 2:2:1.
The inflammatory cytokine production is reduced with induction of proapoptotic events, inhibition of keratinocyte proliferation, reduced expression of adhesion molecules, and diminished inflammatory infiltrate within psoriatic plaques. 
Nastajanje provnetnih citokinov se zmanjša z induciranjem proapoptotičnih dogodkov, inhibicijo proliferacije keratinocitov, zmanjšanim izražanjem adhezijskih molekul in zmanjšanim vnetnim infiltratom v psoriatičnih plakih.
In vitro studies have shown that hydrolysis of dimethyl fumarate to monomethyl fumarate occurs rapidly at pH 8 (pH in the small intestine), but not at pH 1 (pH in the stomach). 
Študije in vitro so pokazale, da hidroliza dimetilfumarata v monometilfumarat hitro poteče pri pH 8 (pH v tankem črevesju), ne pa pri pH 1 (pH v želodcu).
Gastrointestinal tolerability can be improved by following the dose titration schedule on initiating Skilarence treatment and by taking Skilarence with food (see sections 4.2 and 4.8). 
Prenašanje v prebavilih je mogoče izboljšati z upoštevanjem načrta za titracijo ob začetku zdravljenja z zdravilom Skilarence in z jemanjem zdravila Skilarence skupaj s hrano (glejte poglavji 4.2 in 4.8).
Diarrhoea was a common adverse reaction (36.9%) among patients taking Skilarence, leading to medicinal product withdrawal in about 10% of patients. 
Diareja je bila pri bolnikih, ki so jemali zdravilo Skilarence, pogost neželeni učinek (36,9 %) in je povzročila opustitev jemanja zdravila pri približno 10 % bolnikov.
Avoid strong alcoholic drinks (more than 50 ml of spirits containing more than 30% alcohol by volume) during treatment with Skilarence, as alcohol can interact with this medicine. 
Med zdravljenjem z zdravilom Skilarence se izogibajte uživanju močnih alkoholnih pijač (več kot 50 ml žgane pijače, ki vsebuje več kot 30 volumskih odstotkov alkohola), saj lahko alkohol medsebojno deluje s tem zdravilom.
There are no data available with Skilarence in paediatric patients. 
Podatkov o uporabi zdravila Skilarence pri pediatričnih bolnikih ni na voljo.
If the side effects are not troublesome, your dose will be increased until your condition is well controlled. 
Če neželeni učinki ne bodo povzročali težav, bo vaš odmerek povečeval, dokler vaša bolezen ne bo zadostno nadzorovana.
The coating of the gastro-resistant tablets is designed to prevent gastric irritation. 
Obloga gastrorezistentnih tablet je zasnovana za preprečevanje draženja črevesja.
The objectives of the educational programme are to inform health care professionals about the risk of serious infections, mainly opportunistic infections such as progressive multifocal leukoencephalopathy (PML), and to provide guidance on the monitoring of lymphocyte and leukocyte count abnormalities. 
Cilji izobraževalnega programa so obveščanje zdravstvenih delavcev o tveganjih resnih okužb, zlasti oportunističnih okužb, kot je progresivna multifokalna levkoencefalopatija (PML), in posredovanje smernic za spremljanje nenormalnih vrednosti limfocitov in levkocitov.
There was a trend in the efficacy endpoint PASI score mean % change from baseline, indicating the onset of a clinical response to Skilarence as early as week 3 (-11.8%) which became statistically significant compared to placebo by week 8 (-30.9%). 
Opazili so trend v primarnem opazovanem dogodku učinkovitosti - spremembo povprečne ocene PASI v % od izhodišča, kar kaže na nastop kliničnega odziva na zdravilo Skilarence že v 3. tednu (-11,8 %), ki je do 8. tedna postal statistično pomemben v primerjavi s placebom (-30,9 %).
At week 16 of treatment, 13/175 (7.4%) of patients were noted to have lymphocyte levels <0.7x 10 
V 16. tednu zdravljenja je bilo 13/175 (7,4 %) bolnikov obveščenih, da imajo ravni limfocitov < 0,7 x 10
Reproduction toxicity No fertility or pre- and post-natal development studies have been conducted with Skilarence. 
Reproduktivna toksičnost Študij plodnosti ali predporodnega in poporodnega razvoja z zdravilom Skilarence niso izvedli.
Despite the high inter-subject variability, the exposure measured as AUC and Cmax was generally dose-proportional after single dose administration of 4 x 30 mg dimethyl fumarate tablets (total dose of 120 mg) and 2 x 120 mg dimethyl fumarate tablets (total dose of 240 mg). 
Kljub veliki variabilnosti med preiskovanci je bila izpostavljenost, merjena kot AUC in Cmax na splošno sorazmerna z odmerkom po dajanju enkratnega odmerka 4 tablete po 30 mg dimetilfumarata (skupni odmerek 120 mg) in 2 tableti po 120 mg dimetilfumarata (skupni odmerek 240 mg).
A part of the total dimethyl fumarate is hydrolysed by esterases and the alkaline milieu of the small intestine, while the remainder enters the portal vein blood. 
Del celokupnega dimetilfumarata se hidrolizira s pomočjo esteraz in alkalnega okolja v tankem črevesju, medtem ko preostanek vstopi v kri v portalni veni.
If you get severe or prolonged diarrhoea with Skilarence, other medicines may not work as well as they should. 
Če se med jemanjem zdravila Skilarence pri vas pojavi huda ali dalj časa trajajoča driska, druga zdravila morda ne bodo delovala tako učinkovito, kot bi morala.
However, if you become flushed and get any of the following signs: - wheezing, difficulty breathing or shortness of breath, - swelling of the face, lips, mouth or tongue stop taking Skilarence and call a doctor straight away. 
Če zardevate ali opazite katerega od naslednjih znakov: - sopenje, težave z dihanjem ali zasoplost, - otekanje obraza, ustnic, ust ali jezika prenehajte jemati zdravilo Skilarence in takoj pokličite zdravnika.
Animal studies have shown reproductive toxicity (see section 5.3). 
Študije na živalih so pokazale toksičen vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
The most common adverse reactions observed with Skilarence in the Phase III clinical study (1102) in psoriasis patients were gastrointestinal events (62.7%), flushing (20.8%) and lymphopenia (10.0%). 
Najpogostejši neželeni učinki, ki so jih opazili pri zdravilu Skilarence v III. fazi klinične študije (1102) s psoriatičnimi bolniki, so bili neželeni učinki na prebavila (62,7 %), vročinsko oblivanje (20,8 %) in limfopenija (10,0 %).
40 gastro-resistant tablets 70 gastro-resistant tablets 90 gastro-resistant tablets 100 gastro-resistant tablets 120 gastro-resistant tablets 180 gastro-resistant tablets 200 gastro-resistant tablets 240 gastro-resistant tablets 300 gastro-resistant tablets 360 gastro-resistant tablets 400 gastro-resistant tablets 
40 gastrorezistentnih tablet 70 gastrorezistentnih tablet 90 gastrorezistentnih tablet 100 gastrorezistentnih tablet 120 gastrorezistentnih tablet 180 gastrorezistentnih tablet 200 gastrorezistentnih tablet 240 gastrorezistentnih tablet 300 gastrorezistentnih tablet 360 gastrorezistentnih tablet 400 gastrorezistentnih tablet
There is no evidence for Skilarence interaction with cytochrome P450 and the most common efflux and uptake transporters, thus no interactions are expected with medicinal products metabolised or transported by these systems (see section 5.2). 
Ni dokazov o medsebojnem delovanju zdravila Skilarence s citokromom P450 in z najpogostejšimi efluksnimi transporterji in transporterji privzema, zato ne pričakujemo medsebojnega delovanja z zdravili, ki se presnavljajo ali prenašajo prek teh sistemov (glejte poglavje 5.2).
The plasma protein binding of monomethyl fumarate is around 50%. 
Vezava monometilfumarata na človeške plazemske beljakovine je približno 50 %.
The biotransformation of dimethyl fumarate does not involve cytochrome P450 isoenzymes. 
Biotransformacija dimetilfumarata ne vključuje izoencimov citokroma P450.
Other haematological disorders 
Druge hematološke motnje
Prior and concomitant treatment with immunosuppressive or immunomodulating therapies Limited data are available on the efficacy and safety of Skilarence in patients who have been previously treated with other immunosuppressive or immunomodulating therapies. 
Predhodno in sočasno zdravljenje z imunosupresivnimi ali imunomodulirajočimi zdravili O učinkovitosti in varnosti zdravila Skilarence pri bolnikih, ki so bili predhodno zdravljeni z imunosupresivnimi ali imunomodulirajočimi zdravili, je na voljo malo podatkov.
In vitro studies have shown that dimethyl fumarate at a therapeutic dose does not inhibit CYP3A4/5 and BCRP and is a weak P-glycoprotein inhibitor. 
Študije in vitro so pokazale, da dimetilfumarat v terapevtskem odmerku ne zavira CYP3A4/5 in BCRP in je šibek zaviralec P-glikoproteina.
If you have severe side effects after an increase in dose, your doctor may recommend that you temporarily go back to the last dose. 
Če se bodo po povečanju odmerka pri vas pojavili hudi neželeni učinki, vam bo zdravnik morda priporočil začasno vrnitev na zadnji odmerek.
In the event of a clinically relevant change in hepatic parameters, particularly in the absence of alternative explanations, consideration should be given to dose reduction or treatment discontinuation. 
V primeru klinično pomembne spremembe jetrnih parametrov, zlasti, če ni alternativne razlage, je treba razmisliti o zmanjšanju odmerka ali prekinitvi zdravljenja.
40, 70, 90, 100, 120, 180, 200, 240, 300, 360 and 400 gastro-resistant tablets in PVC/PVDC-aluminium blister packs. 
40, 70, 90, 100, 120, 180, 200, 240, 300, 360 in 400 gastrorezistentnih tablet v pretisnih omotih PVC/PVDC-aluminij.
Hepatic enzymes increased Serum creatinine increased* 
Preiskave povišane vrednosti jetrnih encimov povišane vrednosti kreatinina v serumu*
Opportunistic infections/progressive multifocal leukoencephalopathy (PML) Cases of opportunistic infections, particularly of progressive multifocal leukoencephalopathy (PML) have been reported with other dimethyl fumarate-containing products (see section 4.8). 
Oportunistične okužbe/progresivna multifokalna levkoencefalopatija (PML) Pri uporabi drugih zdravil, ki so vsebovala dimetilfumarat, so poročali o primerih oportunističnih okužb, še zlasti o progresivni multifokalni levkoencefalopatiji (PML) (glejte poglavje 4.8).
No data are available on the efficacy and safety of Skilarence when taken concomitantly with other immunosuppressive or immunomodulating therapies (see section 4.5). 
Podatkov o učinkovitosti in varnosti zdravila Skilarence ob sočasnem jemanju drugih imunosupresivnih ali imunomodulirajočih zdravil ni na voljo (glejte poglavje 4.5).
Do not crush, break, dissolve or chew your tablets, as they have a special coating to help prevent irritation of your stomach. 
Tablet ne drobite, ne razpolavljajte, ne raztapljajte in ne žvečite, saj imajo posebno oblogo, ki preprečuje draženje črevesja.
Skilarence with alcohol 
Zdravilo Skilarence skupaj z alkoholom
However, Skilarence has not been studied in patients with severe renal impairment, and some cases of renal toxicity have been reported during post-marketing surveillance with fumaric acid esters. 
Vendar pa zdravila Skilarence niso preučevali pri bolnikih s hudo okvaro delovanja ledvic, v obdobju trženja zdravila pa so poročali o nekaj primerih ledvične toksičnosti z estri fumarne kisline.
Fanconi syndrome is a rare but serious kidney disorder which may occur with Skilarence. 
Fanconijev sindrom je redka, a resna bolezen ledvic, ki se lahko pojavi ob zdravljenju z zdravilom Skilarence.
In rare cases hypophosphataemic osteomalacia with non-localised bone pain, elevated alkaline phosphatase in serum and stress fractures may occur. 
V redkih primerih lahko pride do hipofosfatemične osteomalacije z nelokalizirano bolečino v kosteh, zvišanjem alkalne fosfataze v serumu in stresnimi zlomi.
During treatment 
Med zdravljenjem
In the event of a clinically relevant change in renal function, particularly in the absence of alternative explanations, consideration should be given to dosage reduction or treatment discontinuation. 
V primeru klinično pomembne spremembe v delovanju ledvic, zlasti, če ni alternativne razlage, je treba razmisliti o zmanjšanju odmerka ali prekinitvi zdravljenja.