natgillin/translations-raw huggingface dataset:
If a particular dose increase is not tolerated, it may be temporarily reduced to the last tolerated dose. 
Če bolnik ne prenaša posameznega povečanja odmerka, je odmerek mogoče začasno znižati na zadnji odmerek, ki ga je bolnik še prenašal.
It has not been studied in patients with pre-existing low leukocyte or lymphocyte counts. 
Zdravila Skilarence niso preučili pri bolniki z obstoječim nizkim številom levkocitov ali limfocitov.
In vitro studies have shown that monomethyl fumarate at the therapeutic dose does not inhibit or induce any of the cytochrome P450 enzymes, it is not a substrate or inhibitor of P-glycoprotein and is not an inhibitor of the most common efflux and uptake transporters. 
Študije in vitro so pokazale, da monometilfumarat v terapevtskem odmerku ne zavira ali inducira nobenega encima citokroma P450, da ni substrat ali zaviralec P-glikoproteina in da ni zaviralec najpogostejših efluksnih transporterjev in transporterjev privzema.
Skilarence 30 mg 42, 70 and 210 gastro-resistant tablets in PVC/PVDC-aluminium blister packs. 
Skilarence 30 mg 42, 70 in 210 gastrorezistentnih tablet v pretisnih omotih PVC/PVDC-aluminij.
Skilarence is not recommended in women of child-bearing potential not using appropriate contraception. 
Zdravila Skilarence ne uporabljajte pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
Taking these medicines with Skilarence could increase the risk of side effects on your immune system. 
Jemanje teh zdravil skupaj z zdravilom Skilarence bi lahko povečalo tveganje za pojav stranskih učinkov na vaš imunski sistem.
Carcinogenicity 
Karcinogeneza
Caution should be exercised when prescribing medicinal products with a narrow therapeutic index that require absorption in the intestinal tract. 
Previdnost je potrebna pri predpisovanju zdravil z ozkim terapevtskim indeksom, ki se presnavljajo v prebavilih.
Skilarence tablets are used to treat moderate to severe plaque psoriasis in adults. 
Tablete zdravila Skilarence se uporabljajo za zdravljenje zmerne do hude psoriaze v plakih pri odraslih.
Superiority testing vs placebo PASI 75, n (%) p-value a a 
Testiranje superiornosti v primerjavi s placebom PASI 75, n (%) p-vrednost
What Skilarence is and what it is used for 
Kaj je zdravilo Skilarence in za kaj ga uporabljamo
Skilarence is indicated for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy. 
Zdravilo Skilarence je indicirano za zdravljenje zmerne do hude psoriaze v plakih pri odraslih, ki potrebujejo zdravljenje s sistemskim zdravilom.
- Severe hepatic or renal impairment. 
− Huda okvara jeter ali ledvic.
42 gastro-resistant tablets 70 gastro-resistant tablets 210 gastro-resistant tablets 
42 gastrorezistentnih tablet 70 gastrorezistentnih tablet 210 gastrorezistentnih tablet
*Additional adverse reactions reported with Fumaderm, a related medicinal product containing dimethyl fumarate along with other fumaric acid esters. 
*Dodatni neželeni učinki, o katerih so poročali pri zdravljenju z zdravilom Fumaderm, ki je podobno zdravilo, ki vsebuje dimetilfumarat, skupaj z drugimi estri fumarne kisline.
Data from the Phase III clinical study as well as from the literature show that changes in haematological parameters are most likely to occur during the first 3 months after starting treatment with dimethyl fumarate. 
Podatki iz klinične študije III. faze in podatki iz literature kažejo, da se spremembe hematoloških parametrov najverjetneje pojavijo v prvih 3 mesecih po začetku zdravljenja z dimetilfumaratom.
Each gastro-resistant tablet contains 136.8 mg lactose (as monohydrate). 
Ena gastrorezistentna tableta vsebuje 136,8 mg laktoze (v obliki monohidrata).
The portion of dimethyl fumarate that reacts with glutathione, forming a glutathione-adduct, is metabolised further to its mercapturic acid, which is excreted in the urine. 
Del dimetilfumarata, ki reagira z glutationom in tvori adukt glutationa, se nadalje presnavlja v njegovo merkapturno kislino, ki se izloča z urinom.
A transient increase in mean values of eosinophils was noted as early as week 3, reached a maximum at week 5 and 8, and had returned to baseline values at week 16. 
Že v tretjem tednu so opazili prehodno povečanje povprečnih vrednosti eozinofilcev, ki je doseglo največjo vrednost v 5. in 8. tednu, vrednosti pa so se vrnile na izhodiščne v 16. tednu.
Blue, film-coated, round, biconvex tablet with a diameter of approximately 11.6 mm. 
Modra, filmsko obložena, okrogla, bikonveksna tableta s premerom približno 11,6 mm.
The NOAEL for maternal and embryo-foetal toxicity was 40 mg/kg/day, corresponding to 0.2-fold and 2.0-fold the human systemic exposure at the highest recommended dose (720 mg/day), as AUC and Cmax values, respectively. 
NOAEL za maternalno in embriofetalno toksičnost je bil 40 mg/kg/dan, kar ustreza 0,2-kratni in 2,0- kratni sistemski izpostavljenosti pri človeku pri najvišjem priporočenem odmerku (720 mg/dan), kot vrednosti AUC in Cmax.
White, film-coated, round, biconvex tablet with a diameter of approximately 6.8 mm. Skilarence 120 mg 
Bela, filmsko obložena, okrogla, bikonveksna tableta s premerom približno 6,8 mm. Skilarence 120 mg
In patients experiencing diarrhoea during Skilarence treatment, the effect of oral contraceptives may be reduced and additional barrier methods of contraception may be necessary (see section 4.5). 
Pri bolnicah, pri katerih se med zdravljenjem z zdravilom Skilarence pojavi diareja, se lahko učinek peroralnih kontracepcijskih sredstev zmanjša, zato bo morda treba uporabiti alternativne pregradne kontracepcijske metode (glejte poglavje 4.5).
Skilarence contains lactose. 
Zdravilo Skilarence vsebuje laktozo.
Skilarence may decrease leukocyte and lymphocyte counts (see section 4.8). 
Zdravilo Skilarence lahko zmanjša število levkocitov in limfocitov (glejte poglavje 4.8).
Most patients had moderate psoriasis based on Psoriasis Area and Severity Index (PASI) and Physician's Global Assessment (PGA) scores at baseline: the mean PASI score at baseline was 16.35 and 60% of patients scored as moderate on the PGA. 
Večina bolnikov je imela ob izhodišču zmerno psoriazo na podlagi ocene indeksa PASI [indeks jakosti psoriaze in telesne površine, prizadete s psoriazo] in ocene PGA [celostna ocena, ki jo poda zdravnik]: povprečna ocena PASI je v izhodišču znašala 16,35 in 60 % bolnikov je dobilo oceno PGA »zmerno«.
It is not known how commonly they occur. 
Njuna pogostnost ni znana.
However, because renal elimination plays a minor role in the total clearance from plasma, it is unlikely that renal impairment may affect the pharmacokinetic characteristics of Skilarence (see section 4.2). 
Ker pa izločanje skozi ledvice igra manjšo vlogo pri celokupnem očistku iz plazme, ni preveč verjetno, da bi okvara ledvic lahko vplivala na farmakokinetične lastnosti zdravila Skilarence (glejte poglavje 4.2).
Placebo with a difference of 22.2% for PASI 75 and 20.0% for PGA score clear or almost clear, superiority of Fumaderm vs Placebo with a difference of 25.0% for PASI 75 and 24.4% for PGA score clear or almost clear; b Non-inferiority of Skilarence vs. Fumaderm with a difference of -2.8% for PASI 75 and -4.4% for PGA score clear or almost clear. 
Zdravilo Fumaderm = aktivna primerjava, kombinirano zdravilo z enako količino dimetilfumarata in s 3 monometilnimi fumaratnimi solmi; n = število bolnikov z razpoložljivimi podatki; N = število bolnikov v populaciji; PASI = Psoriasis Area Severity Index; PGA = Physician's Global Assessment; a Večja učinkovitost zdravila Skilarence v primerjavi s placebom z razliko 22,2 % za PASI 75 in 20,0 % za oceno PGA brez znakov ali skoraj brez znakov, superiornost zdravila Fumaderm v primerjavi s placebom z razliko 25,0 % za PASI 75 in 24,4 % za oceno PGA brez znakov ali skoraj brez znakov; b Neinferiornost zdravila Skilarence v primerjavi z zdravilom Fumaderm z razliko -2,8 % za PASI 75 in -4,4 % za oceno PGA brez znakov ali skoraj brez znakov.
The no-observed adverse-effect-level (NOAEL) after 3 months of treatment was 30 mg/kg/day, which corresponds to 2.9-fold and 9.5-fold the human systemic exposure at the highest recommended dose (720 mg/day), as AUC and Cmax values, respectively. 
Raven brez vidnih neželenih učinkov (NOAEL) je bila po treh mesecih zdravljenja 30 mg/kg/dan, kar ustreza 2,9-kratni in 9,5-kratni sistemski izpostavljenosti pri človeku pri najvišjem priporočenem odmerku (720 mg/dan), kot vrednosti AUC in Cmax.
9/L were observed in 1/29 (3.5%) patient at 6 months and 0/28 (0%) at 12 months after stopping treatment. 
Med spremljanjem brez zdravljenja so opazili ravni limfocitov < 0,7 x 109/l pri 1/29 (3,5 %) bolniku v 6. mesecu in 0/28 (0 %) v 12. mesecu po prenehanju zdravljenja.
Marketing Authorisation Holder Almirall, S.A. 
Imetnik dovoljenja za promet z zdravilom Almirall, S.A.
Based on observations in the Phase III clinical study as well as on literature data, flushing is most likely to occur during the early weeks of treatment and tends to lessen with time. 
Na podlagi opažanj iz klinične študije III. faze in podatkov iz literature se vročinsko oblivanje najverjetneje pojavi v zgodnjih tednih zdravljenja in se običajno sčasoma zmanjša.
- Other medicines used to treat psoriasis, such as methotrexate, retinoids, psoralens, ciclosporin, or other immunosuppressants or cytostatics (medicines that affect the immune system). 
- druga zdravila za zdravljenje psoriaze, kot so metotreksat, retinoidi, psoraleni, ciklosporin ali drugi imunosupresivi ali citostatiki (zdravila, ki vplivajo na imunski sistem).
Warnings and precautions Talk to your doctor or pharmacist before taking Skilarence. 
Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Skilarence se posvetujte z zdravnikom ali farmacevtom.
Progressive multifocal leukoencephalopathy* 
Bolezni živčevja glavobol parestezija omotica* progresivna multifokalna levkoencefalopatija*
After oral administration, dimethyl fumarate is not detected in plasma because it is rapidly hydrolysed by esterases to its active metabolite monomethyl fumarate. 
Po peroralnem dajanju dimetilfumarata v plazmi ni mogoče določiti, saj se hitro hidrolizira z esterazami v svoj aktivni presnovek monometilfumarat.
No carcinogenicity studies have been performed for Skilarence. 
Z zdravilom Skilarence niso opravili študij karcinogenosti.
- Other medicines that can affect your kidney function, such as methotrexate or ciclosporin (used to treat psoriasis), aminoglycosides (used to treat infections), diuretics (which increase urine), nonsteroidal anti-inflammatory drugs (used to treat pain) or lithium (used for bipolar disease and depression). 
- druga zdravila, ki lahko vplivajo na delovanje vaših ledvic, kot so metotreksat ali ciklosporin (ki ju uporabljamo za zdravljenje psoriaze), aminoglikozidi (ki jih uporabljamo za zdravljenje okužb), diuretiki (ki povečajo izločanje urina), nesteroidna protivnetna zdravila (ki jih uporabljamo za zdravljenje bolečin) ali litij (ki ga uporabljamo za zdravljenje bipolarne bolezni in depresije).
At 12 months after stopping treatment 3/28 (10.7%) of patients had lymphocyte values below 1.0x10 
V 12. mesecu po prenehanju zdravljenja so imeli 3/28 (10,7 %) bolniki vrednosti limfocitov pod 1,0 x 10
Data from the Phase III clinical study as well as from the literature show that gastrointestinal disorders with dimethyl fumarate-containing products are most likely to occur during the first 2 to 3 months after starting treatment. 
Podatki iz klinične študije III. faze in podatki iz literature kažejo, da se gastrointestinalne motnje pri zdravilih, ki vsebujejo dimetilfumarat, najpogosteje pojavijo v prvih dveh do treh mesecih po začetku zdravljenja.
If you notice new or worsening weakness on one side of the body; clumsiness; changes in vision, thinking or memory; confusion; or personality changes lasting several days, stop taking Skilarence and talk to your doctor straight away. 
Če opazite šibkost ene strani telesa oz. poslabšanje obstoječe šibkosti, nespretnost, spremembe vida, razmišljanja ali spomina, zmedenost ali spremembe osebnosti, ki trajajo več dni, prenehajte jemati zdravilo Skilarence in se takoj posvetujte z zdravnikom.
Skilarence should be used cautiously in combination with other systemic antipsoriatic therapy (e.g. methotrexate, retinoids, psoralens, ciclosporin, immunosuppressants or cytostatics) (see section 4.4). 
Zdravilo Skilarence je treba v kombinaciji z drugimi sistemskimi zdravili za zdravljenje psoriaze (kot so metotreksat, retinoidi, psoraleni, ciklosporin, imunosupresivi ali citostatiki) uporabljati previdno (glejte poglavje 4.4).
Skilarence may have a minor influence on the ability to drive and use machines. 
Zdravilo Skilarence ima blag vpliv na sposobnost vožnje in upravljanja strojev.
Treatment should not be initiated if leukopenia below 3.0x10 
Zdravljenja se ne sme uvesti, če je pri bolniku ugotovljena levkopenija s številom levkocitov pod 3,0 x 10
Since renal elimination plays a minor role in the clearance of Skilarence from plasma, it is unlikely that renal impairment would affect the pharmacokinetic characteristics, and so a need for dose adjustment in patients with mild to moderate renal impairment is not expected (see sections 4.2 and 
Ker izločanje skozi ledvice igra manjšo vlogo pri očistku zdravila Skilarence iz plazme, je malo verjetno, da bi okvarjeno delovanje ledvic vplivalo na farmakokinetične lastnosti, zato ni pričakovati potrebe po prilagajanju odmerka pri bolnikih z blago do zmerno okvaro delovanja ledvic (glejte poglavji 4.2 in 5.2).
After oral administration of a single Skilarence 120 mg tablet in healthy subjects, monomethyl fumarate reached plasma peak concentrations of around 1325 ng/mL and 1311 ng/mL under fasted or fed conditions, respectively. 
Po peroralnem dajanju ene tablete zdravila Skilarence 120 mg zdravim preiskovancem je monometilfumarat dosegel najvišje koncentracije v plazmi približno 1.325 ng/ml na tešče in 1.311 ng/ml na poln želodec.
However, as dimethyl fumarate is metabolised by esterases and the alkaline milieu of the small intestine without the involvement of cytochrome P450, hepatic impairment is not expected to influence exposure (see section 4.2). 
Ker pa se dimetilfumarat presnavlja s pomočjo esteraz in alkalnega okolja v tankem črevesju brez udeležbe citokroma P450, ni pričakovati vpliva okvare jeter na izpostavljenost zdravilu (glejte poglavje 4.2).
Uncommon side effects (may affect up to 1 in 100 people): - dizziness - excess protein in the urine (proteinuria) - increase in serum creatinine (a substance in the blood used for measuring how well your kidneys are working) 
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov): - omotica - odvečne beljakovine v urinu (proteinurija) - porast vrednosti kreatinina v serumu (snov v krvi, katere vrednost merimo za ugotavljanje delovanja vaših ledvic)
Symptomatic treatment is indicated in the case of an overdose. 
V primeru prevelikega odmerjanja je indicirano simptomatsko zdravljenje.
For monitoring recommendations and clinical management of haematological adverse reactions, see section 4.4. 
Za priporočila glede spremljanja in klinične obravnave hematoloških neželenih učinkov glejte poglavje 4.4.
What Skilarence 30 mg looks like and contents of the pack Skilarence 30 mg is a white, round tablet with a diameter of approximately 6.8 mm. 
Izgled zdravila Skilarence 30 mg in vsebina pakiranja Zdravilo Skilarence 30 mg je bela, okrogla tableta s premerom približno 6,8 mm.
The following is a list of adverse reactions experienced by patients treated with Skilarence during the clinical study and with Fumaderm, a related medicinal product containing dimethyl fumarate along with other fumaric acid esters. 
Naslednji seznam neželenih učinkov zajema neželene učinke, ki so se pojavili pri bolnikih, zdravljenih z zdravilom Skilarence v klinični študiji in z zdravilom Fumaderm, ki vsebuje dimetilfumarat, skupaj z drugimi estri fumarne kisline.
9/L, blood monitoring should be performed monthly until levels return to 1.0x10 
9/l, je treba krvne preiskave opravljati vsak mesec, dokler niso vrednosti dveh zaporednih krvnih preiskav 1,0 x 10
If the lymphocyte count falls below 0.7x10 
Če število limfocitov kadar koli pade pod 0,7 x 10
Each gastro-resistant tablet contains 34.2 mg lactose (as monohydrate). 
Ena gastrorezistentna tableta vsebuje 34,2 mg laktoze (v obliki monohidrata).
In the third week, Skilarence 30 mg is taken three times daily (1 tablet in the morning, 1 at midday, and 1 in the evening). 
V tretjem tednu se zdravilo Skilarence 30 mg vzame trikrat na dan (1 tableta zjutraj, 1 opoldan in 1 zvečer).
The active ingredient in Skilarence, dimethyl fumarate, is also used in other medicines such as tablets, ointments and baths. 
- dimetilfumarat ali druge fumarate: učinkovina zdravila Skilarence, dimetilfumarat, se uporablja tudi v drugih zdravilih, kot so tablete, mazila in kopeli.
Skilarence is for oral use. 
Zdravilo Skilarence je namenjeno za peroralno uporabo.
Lymphopenia: If the lymphocyte count falls below 1.0x10 
Limfopenija: če število limfocitov pade pod vrednost 1,0 x 10
For monitoring recommendations and clinical management of adverse reactions, see section 4.4. 
Za priporočila glede spremljanja in klinične obravnave neželenih učinkov glejte poglavje 4.4.
How to store Skilarence 6. 
Shranjevanje zdravila Skilarence 6.
Do not breast-feed during treatment with Skilarence. 
V času zdravljenja z zdravilom Skilarence ne dojite.
What Skilarence 120 mg looks like and contents of the pack Skilarence 120 mg is a blue, round tablet with a diameter of approximately 11.6 mm. 
Izgled zdravila Skilarence 120 mg in vsebina pakiranja Zdravilo Skilarence 120 mg je modra, okrogla tableta s premerom približno 11,6 mm.
Very rare side effects (may affect up to 1 in 10,000 people): - acute lymphatic leukaemia (a type of blood cancer) - decrease in all types of blood cells (pancytopenia) 
Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov): - akutna limfatična levkemija (vrsta krvnega raka) - upadanje števila vseh vrst krvnih celic (pancitopenija)
EU/1/17/1201/002 40 tablets EU/1/17/1201/003 70 tablets EU/1/17/1201/004 90 tablets EU/1/17/1201/005 100 tablets EU/1/17/1201/006 120 tablets EU/1/17/1201/007 180 tablets EU/1/17/1201/008 200 tablets EU/1/17/1201/009 240 tablets EU/1/17/1201/012 300 tablets EU/1/17/1201/010 360 tablets EU/1/17/1201/011 400 tablets 
EU/1/17/1201/003 70 tablet EU/1/17/1201/004 90 tablet EU/1/17/1201/005 100 tablet EU/1/17/1201/006 120 tablet EU/1/17/1201/007 180 tablet EU/1/17/1201/008 200 tablet EU/1/17/1201/009 240 tablet EU/1/17/1201/012 300 tablet EU/1/17/1201/010 360 tablet EU/1/17/1201/011 400 tablet
No specific studies have been performed in patients with renal impairment. 
Specifičnih študij z bolniki z ledvično okvaro niso izvedli.
In the first week, Skilarence 30 mg is taken once daily (1 tablet in the evening). 
V prvem tednu se zdravilo Skilarence 30 mg vzame enkrat na dan (1 tableta zvečer).
By contrast, unconjugated monomethyl fumarate is detectable in plasma. 
V plazmi pa je mogoče zaznati nekonjugiran monometilfumarat.
How to take Skilarence 
Kako jemati zdravilo Skilarence
In the second week, Skilarence 30 mg is taken twice daily (1 tablet in the morning and 1 in the evening). 
V drugem tednu se zdravilo Skilarence 30 mg vzame dvakrat na dan (1 tableta zjutraj in 1 zvečer).
Skilarence is contraindicated during pregnancy (see section 4.3). 
Zdravilo Skilarence je kontraindicirano med nosečnostjo (glejte poglavje 4.3).
9/L, lymphopenia below 1.0x10 
9/l, limfopenija s številom limfocitov 1,0 x 10
Do not crush, break, dissolve or chew the tablet. 
Tablet ne drobite, razpolavljajte, raztapljajte ali žvečite.
Skilarence has not been studied in patients with pre-existing gastrointestinal disease. 
Zdravila Skilarence niso preučevali pri bolnikih z obstoječo boleznijo prebavil.
Concurrent therapy with nephrotoxic substances (e.g. methotrexate, ciclosporin, aminoglycosides, diuretics, NSAIDs or lithium) may increase the potential for renal adverse reactions (e.g. proteinuria) in patients taking Skilarence. 
Sočasno zdravljenje z nefrotoksičnimi snovmi (npr. z metotreksatom, ciklosporinom, aminoglikozidi, diuretiki, nesteroidnimi protivnetnimi zdravili [NSAR] ali z litijem) lahko pri bolnikih, ki jemljejo zdravilo Skilarence, poveča potencial za neželene ledvične reakcije (npr. za proteinurijo).
Swallow Skilarence tablets whole with liquid. 
Tablete zdravila Skilarence pogoltnite cele z nekaj tekočine.
Further improvement was seen by week 16 
Dodatno izboljšanje so opazili do 16. tedna (-50,8 %).
Gastro-resistant tablet. 
gastrorezistentna tableta
PASI 75 and PGA score clear or almost clear and non-inferior (using a non-inferiority margin of -15%) to the active comparator (p<0.0003) based on PASI 75. 
Po 16 tednih zdravljenja so dokazali, da je zdravilo Skilarence boljše od placeba (p < 0,0001) na podlagi ocen PASI 75 in PGA »brez znakov« ali »skoraj brez znakov« in da ni slabše (uporabljena meja neinferiornosti je bila 15 %) od aktivne primerjave (p < 0,0003) na podlagi ocene PASI 75.
- the other ingredients are: lactose monohydrate, cellulose microcrystalline, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1), talc, triethyl citrate, titanium dioxide (E171), simethicone, indigo carmine (E132) and sodium hydroxide. 
- Druge sestavine zdravila so: laktoza monohidrat, mikrokristalna celuloza, premrežen natrijev karmelozat, brezvoden koloidni silicijev dioksid, magnezijev stearat, metakrilna kislina - etil akrilat kopolimer (1 : 1), smukec, trietil citrat, titanov dioksid (E171), simetikon, indigo karmin (E132) in sodium hydroxid.
PGA score clear or almost clear, n (%) p-value b 
Ocena PGA »brez znakov« ali »skoraj brez znakov«, n (%) p-vrednost b
No specific studies have been performed in patients with hepatic impairment. 
Specifičnih študij z bolniki z okvaro jeter niso izvedli.
EU/1/17/1201/001 42 tablets EU/1/17/1201/013 70 tablets EU/1/17/1201/014 210 tablets 
EU/1/17/1201/001 42 tablet EU/1/17/1201/013 70 tablet
Your doctor will check how well your condition is improving after you start taking Skilarence and will check for side effects. 
Ko boste začeli jemati zdravilo Skilarence, bo zdravnik preverjal, kako se vaše stanje izboljšuje in bo spremljal morebitne resne neželene učinke.
- the other ingredients are: lactose monohydrate, cellulose microcrystalline, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1), talc, triethyl citrate, titanium dioxide (E171) and simethicone. 
- Druge sestavine zdravila so: laktoza monohidrat, mikrokristalna celuloza, premrežen natrijev karmelozat, brezvoden koloidni silicijev dioksid, magnezijev stearat, metakrilna kislina - etil akrilat kopolimer (1 : 1), smukec, trietil citrat, titanov dioksid (E171) in simetikon.
Dimethyl fumarate has been shown to cross the placental membrane into foetal blood in rats. 
Dokazali so, da dimetilfumarat prek membrane placente podgan prehaja v kri plodu.
There were no effects on foetal body weights or malformations attributed to maternal administration of dimethyl fumarate during the embryo-foetal development study in rats. 
V času študije razvoja zarodka in plodu pri podganah učinkov na telesne mase zarodkov ali malformacij, ki bi jih lahko pripisali dajanju dimetilfumarata materam, ni bilo.
What Skilarence is used for 
Za kaj se uporablja zdravilo Skilarence
You may feel dizzy or tired after taking Skilarence. 
Po jemanju zdravila Skilarence ste lahko omotični ali utrujeni.
Therefore, Skilarence is contraindicated during breastfeeding (see section 4.3). 
Zato je zdravilo Skilarence kontraindicirano med dojenjem (glejte poglavje 4.3).
No dose adjustment is needed in patients with mild to moderate renal impairment (see section 5.2). 
Pri bolnikih z blago do zmerno ledvično okvaro prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
Therapy should be discontinued and caution is advised if other pathological results occur. 
Če se pojavijo drugi patološki rezultati, je treba zdravljenje prekiniti, hkrati pa je priporočljivo previdno ravnanje.
Common Common Common Rare 
pogosti pogosti pogosti redki
Common Common Common 
Skupni dnevni odmerek