FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Croatian: U bolesnica koje imaju dijareju tijekom liječenja lijekom Skilarence djelotvornost oralnih kontraceptiva može biti smanjena te mogu biti potrebne dodatne mehaničke metode kontracepcije (vidjeti dio 4.5).
English: At 12 months after stopping treatment 3/28 (10.7%) of patients had lymphocyte values below 1.0x10
Croatian: Dvanaest (12) mjeseci nakon prekida terapije 3/28 (10,7 %) bolesnika imalo je vrijednosti limfocita niže od 1,0x10
English: Non-inferiority of Skilarence vs. Fumaderm PASI 75, n (%) p-value
Croatian: Neinferiornost lijeka Skilarence u odnosu na Fumaderm PASI 75, n (%)
English: 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.
Croatian: Nakon postizanja klinički značajnog poboljšanja kožnih lezija, treba razmotriti postupno smanjenje dnevne doze lijeka Skilarence do individualno prilagođene doze održavanja.
English: Skilarence tablets are used to treat moderate to severe plaque psoriasis in adults.
Croatian: Tablete Skilarence koriste se za liječenja umjerene do teške plak psorijaze u odraslih.
English: It is unknown whether dimethyl fumarate or its metabolites are excreted in human milk.
Croatian: Nije poznato izlučuje li se dimetilfumarat ili njegovi metaboliti u majčino mlijeko.
English: 593, Sant Andreu de la Barca, Barcelona, 08740, Spain
Croatian: Nacional II, Km. 593, Sant Andreu de la Barca, Barcelona, 08740, Španjolska
English: Further studies have shown that dimethyl fumarate (and to a lesser extent monomethyl fumarate) reacts partially with reduced glutathione forming a glutathioneadduct.
Croatian: Daljnja ispitivanja pokazala su da dimetilfumarat (a u manjoj mjeri i monometilfumarat) djelomično reagira s reduciranim glutationom te nastaje glutation-spoj
English: 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.
Croatian: Udio dimetilfumarata koji reagira s glutationom, stvarajući glutation spoj, metabolizira se dalje u svoju merkapturnu kiselinu, koja se izlučuje u urin.
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.
Croatian: Nakon peroralne primjene jedne tablete lijeka Skilarence od 120 mg u zdravih ispitanika, monometilfumarat postiže vršne koncentracije u plazmi od otprilike 1325 ng/mL i 1311 ng/mL natašte, odnosno nakon jela.
English: 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.
Croatian: Neke od ovih nuspojava, kao što je crvenilo lica ili tijela (navale crvenila), proljev, želučani problemi i mučnina se obično poboljšaju s nastavkom liječenja.
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).
Croatian: Skilarence je potrebno oprezno koristiti u kombinaciji s drugom sistemskom terapijom protiv psorijaze (npr. metotreksatom, retinoidima, psoralenima, ciklosporinom, imunosupresivima ili citostaticima) (vidjeti dio 4.4).
English: The biotransformation of dimethyl fumarate does not involve cytochrome P450 isoenzymes.
Croatian: Biotransformacija dimetilfumarata ne uključuje citokrom P450 izoenzime.
English: *Additional adverse reactions reported with Fumaderm, a related medicinal product containing dimethyl fumarate along with other fumaric acid esters.
Croatian: * Dodatne nuspojave uz prijavljene za lijek Fumaderm, sličan lijek koji sadrži dimetilfumarat zajedno s drugim esterima fumaratne kiseline.
English: Dimethyl fumarate has been shown to cross the placental membrane into foetal blood in rats.
Croatian: Dokazano je da dimetilfumarat prolazi kroz placentarnu barijeru u krv fetusa u štakora.
English: If the lymphocyte count falls below 0.7x10
Croatian: Ako limfociti padnu ispod 0,7x10
English: 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.
Croatian: Ispitivanja in vitro pokazala su da dimetilfumarat pri terapijskim dozama ne inhibira CYP3A4/5 i BCRP te da je slab inhibitor P-glikoproteina.
English: 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.
Croatian: Randomizirano je 704 bolesnika za primanje lijeka Skilarence, aktivnog komparatora (Fumaderm, kombiniranim lijekom s istim sadržajem dimetilfumarata i 3 monoetilfumaratnim solima) ili placeba u omjeru 2:2:1.
English: 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.
Croatian: Ispitivanja in vitro pokazala su da monometilfumarat pri terapijskim dozama ne inhibira niti inducira bilo koji od enzima citokroma P450, nije supstrat niti inhibitor P-glikoproteina te nije inhibitor većine uobičajenih efluksnih i unosnih membranskih prijenosnika.
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.
Croatian: U nastavku je popis nuspojava koje su imali bolesnici liječeni lijekom Skilarence tijekom kliničkog ispitivanja i s lijekom Fumaderm, sličnog lijeka koji sadrži dimetilfumarat zajedno s drugim esterima fumaratne kiseline.
English: You may feel dizzy or tired after taking Skilarence.
Croatian: Možete osjećati omaglicu ili umor nakon uzimanja lijeka Skilarence.
English: 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).
Croatian: Međutim, budući da eliminacija putem bubrega ima manju ulogu u ukupnom klirensu iz plazme, nije vjerojatno da oštećenje bubrega može utjecati na farmakokinetičke karakteristike lijeka Skilarence (vidjeti dio 4.2).
English: Skilarence is for oral use.
Croatian: Skilarence je namijenjen za peroralnu primjenu.
English: Diarrhoea was a common adverse reaction (36.9%) among patients taking Skilarence, leading to medicinal product withdrawal in about 10% of patients.
Croatian: Česta nuspojava u bolesnika koji su uzimali Skilarence bila je dijareja (36,9 %) što je dovelo do prekida uzimanja lijeka u otprilike 10 % bolesnika.
English: 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.
Croatian: Podaci iz kliničkog ispitivanja faze III, kao i iz literature, pokazuju da su promjene hematoloških parametara najvjerojatnije tijekom prva 3 mjeseca od početka liječenja dimetilfumaratom.
English: At week 16 of treatment, 13/175 (7.4%) of patients were noted to have lymphocyte levels <0.7x 10
Croatian: U 16. tjednu liječenja, 13/175 (7,4 %) bolesnika je imalo vrijednosti broja limfocita <0,7x10
English: If you need a vaccination, talk to your doctor.
Croatian: Ako se trebate cijepiti, obratite se liječniku.
English: 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.
Croatian: U slučaju klinički relevantne promjene bubrežne funkcije, naročito u odsustvu drugih objašnjenja, potrebno je razmotriti smanjenje doze ili prekid liječenja.
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.
Croatian: Kako Skilarence 30 mg izgleda i sadržaj pakiranja Skilarence 30 mg je bijela, okrugla tableta s promjerom približno 6,8 mm.
English: Industrias Farmaceuticas Almirall, S.A.
Croatian: Industrias Farmacéuticas Almirall, S.A. Ctr.
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)
Croatian: - povraćanje - zatvor - vjetrovi (flatulencija), nelagoda u želucu, loša probava - smanjeni apetit - glavobolja - osjećaj umora - slabost - osjećaj vrućine - abnormalni osjećaji na koži, kao što su svrbež, žarenje, bockanje, škakljanje ili trnci - ružičaste ili crvene mrlje na koži (eritem)
English: PGA score clear or almost clear, n (%) p-value b
Croatian: PGA rezultat „čisto“ ili „gotovo čisto“, n (%) p-vrijednost
English: Marketing Authorisation Holder Almirall, S.A.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Almirall, S.A.
English: During the treatment free follow up, lymphocyte levels of <0.7x 10
Croatian: Tijekom faze praćenja bez terapije, zabilježene su razine limfocita od <0,7x 10
English: Vaccination during treatment with Skilarence has not been studied.
Croatian: Cijepljenje tijekom liječenja lijekom Skilarence nije ispitivano.
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)
Croatian: Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba): - omaglica - višak proteina u urinu (proteinurija) - povišena razina kreatinina u serumu (tvar u krvi koja se koristi za mjerenje koliko dobro Vam rade bubrezi)
English: Tablet strength
Croatian: Jačina tablete
English: This dose is then increased by 1 Skilarence 120 mg tablet per week at different times of day for the subsequent 5 weeks, as shown in the table below.
Croatian: Doza se zatim kroz sljedećih pet tjedana povećava svaki tjedan za 1 tabletu lijeka Skilarence 120 mg, u različito doba dana, kako je prikazano u tablici u nastavku.
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.
Croatian: Podaci iz kliničkog ispitivanja faze III, kao i iz literature, pokazuju da je pojava gastrointestinalnih poremećaja uz lijekove koji sadrže dimetilfumarat najvjerojatnija u prva 2 do 3 mjeseca od početka liječenja.
English: Each gastro-resistant tablet contains 136.8 mg lactose (as monohydrate).
Croatian: Jedna želučanootporna tableta sadrži 136,8 mg laktoze (u obliku hidrata).
English: Blue, film-coated, round, biconvex tablet with a diameter of approximately 11.6 mm.
Croatian: Plava, filmom obložena, okrugla, bikonveksna tableta promjera približno 11,6 mm.
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.
Croatian: 75 i 20,0 % za PGA rezultat „čisto“ ili „gotovo čisto“, superiornost lijeka Fumaderm u odnosu na placebo s razlikom od 25,0 % za PASI 75 i 24,4% za PGA rezultat „čisto“ ili „gotovo čisto“; b Neinferiornost lijeka Skilarence u odnosu na
English: 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%).
Croatian: Srednja vrijednost postotka promjene od početne vrijednosti rezultata PASI kao mjera ishoda djelotvornosti pokazala je trend koji upućuje na rani klinički odgovor na Skilarence, već u 3. tjednu (-11,8 %), koji je postao statistički značajan do 8. tjedna (-30,9 %).
English: The majority of patients reported a “very large” or “extremely large” effect of psoriasis on their life based on the Dermatology Life Quality Index (DLQI), with a mean DLQI score of 11.5.
Croatian: Većina bolesnika prijavila je „jako veliki“ ili „ekstremno veliki“ učinak psorijaze na njihov život procijenjeno na temelju Dermatološkog indeksa kvalitete života (engl.
English: Skin burning sensation Pruritus
Croatian: Osjećaj žarenja kože Pruritus
English: 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.
Croatian: U slučaju klinički relevantne promjene parametara funkcije jetre, naročito u odsustvu drugih objašnjenja, potrebno je razmotriti smanjenje doze ili prekid liječenja.
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.
Croatian: Kako Skilarence 120 mg izgleda i sadržaj pakiranja Skilarence 120 mg je plava, okrugla tableta s promjerom približno 11,6 mm.
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).
Croatian: - Drugi lijekovi koji mogu utjecati na rad bubrega, kao što su metotreksat ili ciklosporin (koriste se za liječenje psorijaze), aminoglikozidi (koriste se za liječenje infekcija), diuretici (koji povećavaju izmokravanje), nesteroidni protuupalni lijekovi (koriste se za liječenje boli) ili litij (koristi se za bipolarni poremećaj i depresiju).
English: - Other medicines used to treat psoriasis, such as methotrexate, retinoids, psoralens, ciclosporin, or other immunosuppressants or cytostatics (medicines that affect the immune system).
Croatian: - Druge lijekove za liječenje psorijaze, kao što su metotreksat, retinoidi, psoraleni, ciklosporin ili drugi imunosupresivi ili citostatici (lijekovi koji utječu na imunosni sustav).
English: Very common Very common Common Common Very rare Very rare
Croatian: Vrlo često Vrlo često Vrlo često Vrlo često Često Često Često Često Često
English: Pre-existing gastrointestinal disease
Croatian: Prethodno prisutne gastrointestinalne bolesti
English: 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
Croatian: 40 želučanootpornih tableta 70 želučanootpornih tableta 90 želučanootpornih tableta 100 želučanootpornih tableta 120 želučanootpornih tableta 180 želučanootpornih tableta 200 želučanootpornih tableta 240 želučanootpornih tableta 300 želučanootpornih tableta 360 želučanootpornih tableta 400 želučanootpornih tableta
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).
Croatian: U trećem tjednu, Skilarence 30 mg uzima se triput dnevno (1 tableta ujutro, 1 u podne i 1 uvečer).
English: Flatulence
Croatian: Flatulencija
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.
Croatian: Temeljeno na opažanjima u kliničkom ispitivanju faze III, kao i na podacima iz literature, vjerojatnost pojave navale crvenila najveća je tijekom prvih tjedana liječenja te se s vremenom smanjuje.
English: Further improvement was seen by week 16
Croatian: Uočeno je i daljnje poboljšanje do 16. tjedna (-50,8 %).
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.
Croatian: Razina bez zapaženog štetnog učinka (NOAEL) nakon 3 mjeseca liječenja bila je 30 mg/kg/dan, što odgovara izloženosti od 2,9 puta, odnosno 9,5 puta sistemske izloženosti kod čovjeka pri najvećoj preporučenoj dozi (720 mg/kg/dan) prema vrijednostima AUC, odnosno Cmax.
English: Dizziness*
Croatian: Omaglica*
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
Croatian: Budući da eliminacija putem bubrega ima manju ulogu u klirensu lijeka Skilarence iz plazme, nije vjerojatno da bi oštećenje bubrega utjecalo na farmakokinetičke karakteristike te se ne očekuje potreba prilagodbe doze u bolesnika s blagim do umjerenim oštećenjem bubrega (vidjeti dijelove 4.2 i 5.2).
English: In the first week, Skilarence 30 mg is taken once daily (1 tablet in the evening).
Croatian: U prvom tjednu, Skilarence 30 mg uzima se jednom dnevno (1 tableta uvečer).
English: 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.
Croatian: NOAEL za majčinsku i embriofetalnu toksičnost bila je 40 mg/kg/dan, što odgovara izloženosti od 0,2 puta i 2,0 puta sistemske izloženosti pri najvećoj preporučenoj dozi (720 mg/kg/dan) prema vrijednostima AUC, odnosno Cmax.
English: Lymphopenia: If the lymphocyte count falls below 1.0x10
Croatian: Limfopenija: Ako broj limfocita padne ispod 1,0x 10
English: For monitoring recommendations and clinical management of haematological adverse reactions, see section 4.4.
Croatian: Za preporuke o praćenju i za kliničko zbrinjavanje hematoloških nuspojava vidjeti dio 4.4.
English: Your dose will be increased every week as shown in the table below (switching to 120 mg Skilarence tablets from week 4 onwards).
Croatian: Doza će Vam se povećavati svaki tjedan, kako je prikazano u tablici u nastavku (a od 4. tjedna nadalje prijeći ćete na tablete Skilarence od 120 mg).
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)
Croatian: Vrlo rijetke nuspojave (mogu se javiti u do 1 na 10 000 osoba): - akutna limfatična leukemija (vrsta raka krvi) - smanjenje broja svih vrsta krvnih stanica (pancitopenija)
English: These medicines taken together with Skilarence could increase the risk of side effects on your kidneys.
Croatian: Ako se ovi lijekovi uzimaju zajedno s lijekom Skilarence mogu povećati rizik od bubrežnih nuspojava.
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.
Croatian: Istodobno liječenje nefrotoksičnim tvarima (npr. metotreksatom, ciklosporinom, aminoglikozidima, diureticima, NSAIL-ovima ili litijem) može povećati mogućnost bubrežnih nuspojava (npr. proteinurije) u bolesnika koji uzimaju Skilarence.
English: Taking these medicines with Skilarence could increase the risk of side effects on your immune system.
Croatian: Uzimanje ovih lijekova s lijekom Skilarence može povećati rizik od imunosnih nuspojava.
English: In the second week, Skilarence 30 mg is taken twice daily (1 tablet in the morning and 1 in the evening).
Croatian: U drugom tjednu, Skilarence 30 mg uzima se dvaput dnevno (1 tableta ujutro i 1 uvečer).
English: Skilarence 30 mg 42, 70 and 210 gastro-resistant tablets in PVC/PVDC-aluminium blister packs.
Croatian: 42, 70 i 210 želučanootporne tablete u PVC/PVDC aluminijskim blisterima.
English: Each gastro-resistant tablet contains 34.2 mg lactose (as monohydrate).
Croatian: Jedna želučanootporna tableta sadrži 34,2 mg laktoze (u obliku hidrata).
English: How to take Skilarence
Croatian: Kako uzimati Skilarence
English: Skilarence contains lactose.
Croatian: Skilarence sadrži laktozu.
English: 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.
Croatian: Prolazni porast srednjih vrijednosti broja eozinofila zabilježen je već u 3. tjednu liječenja, s dosegnutim maksimumom u 5. i 8. tjednu te povratkom na početne vrijednosti u 16. tjednu.
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).
Croatian: Međutim, budući da se dimetilfumarat metabolizira esterazama i alkalnim okolišem u tankom crijevu bez uključenosti citokroma P450, ne očekuje se utjecaj oštećenja jetre na izloženost.
English: Common side effects (may affect up to 1 in 10 people): - increase in all white blood cells (leukocytosis) - increase in specific white blood cells called eosinophils - increase in certain enzymes in the blood (used for checking the health of your liver) - being sick
Croatian: Česte nuspojave (mogu se javiti u do 1 na 10 osoba): - povećan broj svih bijelih krvnih stanica (leukocitoza) - povećan broj specifičnih bijelih krvnih stanica pod nazivom eozinofili - povećanje vrijednosti određenih enzima u krvi (koriste se za provjeru zdravlja jetre)
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
Croatian: EU/1/17/1201/002 40 tableta EU/1/17/1201/003 70 tableta EU/1/17/1201/004 90 tableta EU/1/17/1201/005 100 tableta EU/1/17/1201/006 120 tableta EU/1/17/1201/007 180 tableta EU/1/17/1201/008 200 tableta EU/1/17/1201/009 240 tableta EU/1/17/1201/012 300 tableta EU/1/17/1201/010 360 tableta EU/1/17/1201/011 400 tableta
English: For symptoms see below.
Croatian: Za simptome pogledajte tekst u nastavku.
English: EU/1/17/1201/001 42 tablets EU/1/17/1201/013 70 tablets EU/1/17/1201/014 210 tablets
Croatian: EU/1/17/1201/001 42 tableta EU/1/17/1201/013 70 tableta EU/1/17/1201/014 210 tableta
English: If you notice you are passing more urine, are more thirsty and drinking more than normal, your muscles seem weaker, you break a bone, or just have aches and pains, talk to your doctor as soon as possible so that this can be investigated further.
Croatian: Vam se čine slabiji, slomite kost ili samo imate bolove, obratite se svom liječniku što je prije moguće kako bi se to dalje ispitalo.
English: Fertility There are no human or animal data on the effects of Skilarence on fertility.
Croatian: Ne postoje podaci o djelovanju lijeka Skilarence na plodnost u ljudi i životinja.
English: For monitoring recommendations and clinical management of adverse reactions, see section 4.4.
Croatian: Za preporuke o praćenju i kliničko zbrinjavanje nuspojava vidjeti dio 4.4.
English: Skilarence is contraindicated in patients with severe gastrointestinal disease (see sections 4.3).
Croatian: Skilarence je kontraindiciran u bolesnika s teškom gastrointestinalnom bolešću (vidjeti dio 4.3).
English: No specific studies have been performed in patients with hepatic impairment.
Croatian: Nisu provedena posebna ispitivanja u bolesnika s oštećenjem bubrega.