FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 9/L were observed in 1/29 (3.5%) patient at 6 months and 0/28 (0%) at 12 months after stopping treatment.
Slovenian: 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.
English: Marketing Authorisation Holder Almirall, S.A.
Slovenian: Imetnik dovoljenja za promet z zdravilom Almirall, S.A.
English: 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.
Slovenian: 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.
English: - Other medicines used to treat psoriasis, such as methotrexate, retinoids, psoralens, ciclosporin, or other immunosuppressants or cytostatics (medicines that affect the immune system).
Slovenian: - druga zdravila za zdravljenje psoriaze, kot so metotreksat, retinoidi, psoraleni, ciklosporin ali drugi imunosupresivi ali citostatiki (zdravila, ki vplivajo na imunski sistem).
English: Warnings and precautions Talk to your doctor or pharmacist before taking Skilarence.
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Skilarence se posvetujte z zdravnikom ali farmacevtom.
English: Progressive multifocal leukoencephalopathy*
Slovenian: Bolezni živčevja glavobol parestezija omotica* progresivna multifokalna levkoencefalopatija*
English: After oral administration, dimethyl fumarate is not detected in plasma because it is rapidly hydrolysed by esterases to its active metabolite monomethyl fumarate.
Slovenian: Po peroralnem dajanju dimetilfumarata v plazmi ni mogoče določiti, saj se hitro hidrolizira z esterazami v svoj aktivni presnovek monometilfumarat.
English: No carcinogenicity studies have been performed for Skilarence.
Slovenian: Z zdravilom Skilarence niso opravili študij karcinogenosti.
English: - 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).
Slovenian: - 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).
English: At 12 months after stopping treatment 3/28 (10.7%) of patients had lymphocyte values below 1.0x10
Slovenian: V 12. mesecu po prenehanju zdravljenja so imeli 3/28 (10,7 %) bolniki vrednosti limfocitov pod 1,0 x 10
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Skilarence may have a minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Skilarence ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: Treatment should not be initiated if leukopenia below 3.0x10
Slovenian: Zdravljenja se ne sme uvesti, če je pri bolniku ugotovljena levkopenija s številom levkocitov pod 3,0 x 10
English: 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
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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)
Slovenian: 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)
English: Symptomatic treatment is indicated in the case of an overdose.
Slovenian: V primeru prevelikega odmerjanja je indicirano simptomatsko zdravljenje.
English: For monitoring recommendations and clinical management of haematological adverse reactions, see section 4.4.
Slovenian: Za priporočila glede spremljanja in klinične obravnave hematoloških neželenih učinkov glejte poglavje 4.4.
English: 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.
Slovenian: Izgled zdravila Skilarence 30 mg in vsebina pakiranja Zdravilo Skilarence 30 mg je bela, okrogla tableta s premerom približno 6,8 mm.
English: Toxicology
Slovenian: Toksikologija
English: 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.
Slovenian: 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.
English: 9/L, blood monitoring should be performed monthly until levels return to 1.0x10
Slovenian: 9/l, je treba krvne preiskave opravljati vsak mesec, dokler niso vrednosti dveh zaporednih krvnih preiskav 1,0 x 10
English: If the lymphocyte count falls below 0.7x10
Slovenian: Če število limfocitov kadar koli pade pod 0,7 x 10
English: Each gastro-resistant tablet contains 34.2 mg lactose (as monohydrate).
Slovenian: Ena gastrorezistentna tableta vsebuje 34,2 mg laktoze (v obliki monohidrata).
English: 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).
Slovenian: V tretjem tednu se zdravilo Skilarence 30 mg vzame trikrat na dan (1 tableta zjutraj, 1 opoldan in 1 zvečer).
English: The active ingredient in Skilarence, dimethyl fumarate, is also used in other medicines such as tablets, ointments and baths.
Slovenian: - dimetilfumarat ali druge fumarate: učinkovina zdravila Skilarence, dimetilfumarat, se uporablja tudi v drugih zdravilih, kot so tablete, mazila in kopeli.
English: Skilarence is for oral use.
Slovenian: Zdravilo Skilarence je namenjeno za peroralno uporabo.
English: Lymphopenia: If the lymphocyte count falls below 1.0x10
Slovenian: Limfopenija: če število limfocitov pade pod vrednost 1,0 x 10
English: For monitoring recommendations and clinical management of adverse reactions, see section 4.4.
Slovenian: Za priporočila glede spremljanja in klinične obravnave neželenih učinkov glejte poglavje 4.4.
English: How to store Skilarence 6.
Slovenian: Shranjevanje zdravila Skilarence 6.
English: Do not breast-feed during treatment with Skilarence.
Slovenian: V času zdravljenja z zdravilom Skilarence ne dojite.
English: 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.
Slovenian: Izgled zdravila Skilarence 120 mg in vsebina pakiranja Zdravilo Skilarence 120 mg je modra, okrogla tableta s premerom približno 11,6 mm.
English: 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)
Slovenian: 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)
English: 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
Slovenian: 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
English: No specific studies have been performed in patients with renal impairment.
Slovenian: Specifičnih študij z bolniki z ledvično okvaro niso izvedli.
English: EU/1/17/1201/001 EU/1/17/1201/002 EU/1/17/1201/003 EU/1/17/1201/004 EU/1/17/1201/005 EU/1/17/1201/006 EU/1/17/1201/007 EU/1/17/1201/008 EU/1/17/1201/009
Slovenian: EU/1/17/1201/001 EU/1/17/1201/002 EU/1/17/1201/003 EU/1/17/1201/004 EU/1/17/1201/005 EU/1/17/1201/006 EU/1/17/1201/007 EU/1/17/1201/008 EU/1/17/1201/009 EU/1/17/1201/010 EU/1/17/1201/011 EU/1/17/1201/012 EU/1/17/1201/013 EU/1/17/1201/014
English: In the first week, Skilarence 30 mg is taken once daily (1 tablet in the evening).
Slovenian: V prvem tednu se zdravilo Skilarence 30 mg vzame enkrat na dan (1 tableta zvečer).
English: By contrast, unconjugated monomethyl fumarate is detectable in plasma.
Slovenian: V plazmi pa je mogoče zaznati nekonjugiran monometilfumarat.
English: How to take Skilarence
Slovenian: Kako jemati zdravilo Skilarence
English: In the second week, Skilarence 30 mg is taken twice daily (1 tablet in the morning and 1 in the evening).
Slovenian: V drugem tednu se zdravilo Skilarence 30 mg vzame dvakrat na dan (1 tableta zjutraj in 1 zvečer).
English: Skilarence is contraindicated during pregnancy (see section 4.3).
Slovenian: Zdravilo Skilarence je kontraindicirano med nosečnostjo (glejte poglavje 4.3).
English: 9/L, lymphopenia below 1.0x10
Slovenian: 9/l, limfopenija s številom limfocitov 1,0 x 10
English: Do not crush, break, dissolve or chew the tablet.
Slovenian: Tablet ne drobite, razpolavljajte, raztapljajte ali žvečite.
English: Skilarence has not been studied in patients with pre-existing gastrointestinal disease.
Slovenian: Zdravila Skilarence niso preučevali pri bolnikih z obstoječo boleznijo prebavil.
English: 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.
Slovenian: 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).
English: Swallow Skilarence tablets whole with liquid.
Slovenian: Tablete zdravila Skilarence pogoltnite cele z nekaj tekočine.
English: Further improvement was seen by week 16
Slovenian: Dodatno izboljšanje so opazili do 16. tedna (-50,8 %).
English: Gastro-resistant tablet.
Slovenian: gastrorezistentna tableta
English: 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.
Slovenian: 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.
English: - 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.
Slovenian: - 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.
English: PGA score clear or almost clear, n (%) p-value b
Slovenian: Ocena PGA »brez znakov« ali »skoraj brez znakov«, n (%) p-vrednost b
English: No specific studies have been performed in patients with hepatic impairment.
Slovenian: Specifičnih študij z bolniki z okvaro jeter niso izvedli.
English: EU/1/17/1201/001 42 tablets EU/1/17/1201/013 70 tablets EU/1/17/1201/014 210 tablets
Slovenian: EU/1/17/1201/001 42 tablet EU/1/17/1201/013 70 tablet
English: Your doctor will check how well your condition is improving after you start taking Skilarence and will check for side effects.
Slovenian: Ko boste začeli jemati zdravilo Skilarence, bo zdravnik preverjal, kako se vaše stanje izboljšuje in bo spremljal morebitne resne neželene učinke.
English: - 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.
Slovenian: - 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.
English: Dimethyl fumarate has been shown to cross the placental membrane into foetal blood in rats.
Slovenian: Dokazali so, da dimetilfumarat prek membrane placente podgan prehaja v kri plodu.
English: 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.
Slovenian: 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.
English: What Skilarence is used for
Slovenian: Za kaj se uporablja zdravilo Skilarence
English: You may feel dizzy or tired after taking Skilarence.
Slovenian: Po jemanju zdravila Skilarence ste lahko omotični ali utrujeni.
English: Therefore, Skilarence is contraindicated during breastfeeding (see section 4.3).
Slovenian: Zato je zdravilo Skilarence kontraindicirano med dojenjem (glejte poglavje 4.3).
English: No dose adjustment is needed in patients with mild to moderate renal impairment (see section 5.2).
Slovenian: Pri bolnikih z blago do zmerno ledvično okvaro prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
English: Therapy should be discontinued and caution is advised if other pathological results occur.
Slovenian: Če se pojavijo drugi patološki rezultati, je treba zdravljenje prekiniti, hkrati pa je priporočljivo previdno ravnanje.
English: Common Common Common Rare
Slovenian: pogosti pogosti pogosti redki
English: Common Common Common
Slovenian: Skupni dnevni odmerek
English: Very common
Slovenian: pogosti občasni
English: Dizziness and fatigue may occur following administration of Skilarence (see section 4.8).
Slovenian: Po dajanju zdravila Skilarence se lahko pojavita omotica ali utrujenost (glejte poglavje 4.8).
English: Skilarence 120 mg gastro-resistant tablets dimethyl fumarate
Slovenian: Skilarence 120 mg gastrorezistentne tablete dimetilfumarat
English: Name and address of the manufacturer responsible for batch release
Slovenian: A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca, odgovornega za sproščanje serij Industrias Farmaceuticas Almirall, S.A.
English: What Skilarence 120 mg contains - the active substance is dimethyl fumarate.
Slovenian: Kaj vsebuje zdravilo Skilarence 120 mg - Učinkovina je dimetilfumarat.
English: Skilarence 30 mg gastro-resistant tablets dimethyl fumarate
Slovenian: Skilarence 30 mg gastrorezistentne tablete dimetilfumarat
English: PGA score clear or almost clear, n (%) p-value a a
Slovenian: Ocena PGA »brez znakov« ali »skoraj brez znakov«, n (%) p-vrednost a a
English: Skilarence 30 mg gastro-resistant tablets Skilarence 120 mg gastro-resistant tablets
Slovenian: Skilarence 30 mg gastrorezistentne tablete Skilarence 120 mg gastrorezistentne tablete
English: What Skilarence 30 mg contains - the active substance is dimethyl fumarate.
Slovenian: Kaj vsebuje zdravilo Skilarence 30 mg - Učinkovina je dimetilfumarat.
English: Lactose monohydrate Cellulose microcrystalline Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
Slovenian: Skilarence 30 mg in Skilarence 120 mg Jedro: laktoza monohidrat mikrokristalna celuloza premrežen natrijev karmelozat brezvoden koloidni silicijev dioksid magnezijev stearat
English: - constipation - gas (flatulence), stomach discomfort, indigestion - decreased appetite - headache - feeling tired - weakness - feeling hot - abnormal sensations of the skin, such as itching, burning, stinging, tickling or tingling - pink or red blotches on the skin (erythema)
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov): - porast števila vseh belih krvničk (levkocitoza) - porast števila specifičnih belih krvničk, imenovanih eozinofilci - porast vrednosti določenih encimov v krvi (ki jih uporabljamo za preverjanje zdravja vaših jeter) - bruhanje - zaprtje - vetrovi (napenjanje), občutek neugodja v trebuhu, prebavne motnje - zmanjšan tek - glavobol - občutek utrujenosti - šibkost - občutek vročine - nenormalni občutki na koži, kot so srbenje, pekoča koža, zbadanje, žgečkanje ali ščemenje - rožnate ali rdeče lise na koži (eritem)
English: Hence, Skilarence is contraindicated in patients with severe renal impairment (see section 4.3).
Slovenian: Zato je zdravilo Skilarence kontraindicirano pri bolnikih s hudo okvaro delovanja ledvic (glejte poglavje 4.3).
English: Fatigue Feeling hot Asthenia
Slovenian: Žilne bolezni vročinsko oblivanje zelo pogosti
English: Skilarence has not been studied in patients with severe hepatic impairment, and use of Skilarence is contraindicated in these patients (see section 4.3).
Slovenian: Zdravila Skilarence niso preučili pri bolnikih s hudo okvaro jeter in uporaba zdravila Skilarence je pri teh bolnikih kontraindicirana (glejte poglavje 4.3).
English: One tablet contains 120 mg dimethyl fumarate.
Slovenian: Ena tableta vsebuje 120 mg dimetilfumarata.
English: Skilarence has not been studied in patients with severe hepatic impairment and is contraindicated in these patients (see section 4.3).
Slovenian: Zdravila Skilarence niso preučevali pri bolnikih s hudo okvaro delovanja jeter in je pri teh bolnikih kontraindicirano (glejte poglavje 4.3).
English: One tablet contains 30 mg dimethyl fumarate.
Slovenian: Ena tableta vsebuje 30 mg dimetilfumarata.
English: Skilarence has not been studied in patients with severe renal impairment, and use of Skilarence is contraindicated in these patients (see section 4.3).
Slovenian: Zdravila Skilarence niso preučili pri bolnikih s hudo okvaro ledvic, zato je uporaba zdravila Skilarence pri teh bolnikih kontraindicirana (glejte poglavje 4.3).
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: Skilarence is contraindicated in patients with severe gastrointestinal disease (see sections 4.3).
Slovenian: Zdravilo Skilarence je kontraindicirano pri bolnikih s hudo boleznijo prebavil (glejte poglavje 4.3).
English: OUTER CARTON - SKILARENCE 30 mg GASTRO RESISTANT TABLETS
Slovenian: ZUNANJA ŠKATLA - SKILARENCE 30 mg GASTROREZISTENTNE TABLETE
English: Each gastro-resistant tablet contains 120 mg dimethyl fumarate.
Slovenian: Ena gastrorezistentna tableta vsebuje 120 mg dimetilfumarata.
English: Each gastro-resistant tablet contains 30 mg dimethyl fumarate.
Slovenian: Ena gastrorezistentna tableta vsebuje 30 mg dimetilfumarata.
English: MARKETING AUTHORISATION NUMBER
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
English: What Skilarence is
Slovenian: Kaj je zdravilo Skilarence