FrancophonIA/ELRC3.0 huggingface dataset:
English: • monthly pregnancy tests;
Croatian: • mjesečnim testovima na trudnoću;
English: Decrease in haemoglobin concentrations has been associated with endothelin receptor antagonists (ERAs) including macitentan (see section 4.8).
Croatian: Pad koncentracije hemoglobina povezan je s antagonistima endotelinskih receptora (ERAs) uključujući macitentan (vidjeti dio 4.8).
English: At 36 months, 44.6% of patients on placebo and 29.4% of patients on macitentan 10 mg (Absolute Risk Reduction = 15.2%) had been hospitalised for PAH or died from a PAH-related cause.
Croatian: U 36. mjesecu, 44,6% bolesnika liječenih placebom i 29,4% bolesnika na macitentanu 10 mg (smanjenje apsolutnog rizika = 15,2%) hospitalizirano je zbog PAH-a ili je umrlo od uzroka povezanih s PAH-om.
English: • rifampicin, clarithromycin, telithromycin (antibiotics used to treat infections),
Croatian: • rifampicin, klaritromicin, telitromicin (antibiotici za liječenje infekcija),
English: • ketoconazole (except shampoo), itraconazole, voriconazole (medicines used against fungal infections)
Croatian: • ketokonazol (osim šampona), itrakonazol, vorikonazol (lijekovi protiv gljivičnih infekcija)
English: Macitentan inhibits the breast cancer resistance protein (BCRP) at clinically relevant intestinal concentrations.
Croatian: Macitentan inhibira protein rezistencije karcinoma dojke (BCRP; engl. breast cancer resistance protein) pri klinički relevantnim koncentracijama u crijevima.
English: In people with PAH, these arteries get narrower, so the heart has to work harder to pump blood through them.
Croatian: U osoba s PAH-om, ove se arterije sužavaju tako da srce teže pumpa krv kroz njih.
English: The primary endpoint was the time to first occurrence of a morbidity or mortality event, up to the end of double-blind treatment, defined as death, or atrial septostomy, or lung transplantation, or initiation of intravenous (i.v.)
Croatian: Primarni ishod bilo je vrijeme do prve pojave događaja morbiditeta ili mortaliteta pa sve do kraja dvostruko slijepog liječenja, definiranog kao smrt ili atrijska septostomija ili transplantacija pluća ili početak primjene intravenskih (i.v.) ili supkutanih (s.c.) prostanoida ili druge vrste pogoršanja PAH-a.
English: The safety and efficacy of macitentan in children and adolescents below 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost macitentana u djece i adolescenata s nenavršenih 18 godina nisu još ustanovljene.
English: The pharmacodynamic effect of warfarin on International Normalised Ratio (INR) was not affected by macitentan.
Croatian: Farmakodinamički učinak varfarina na međunarodni normalizirani omjer (INR) nije bio pod utjecajem macitentana.
English: • Elevated liver tests
Croatian: • povišene vrijednosti jetrenih pretraga
English: In patients with pulmonary veno-occlusive disease (obstruction of the lung veins), the use of medicines for treatment of PAH, including Opsumit, may lead to pulmonary oedema.
Croatian: U bolesnika sa venookluzivnom bolešću pluća (začepljenje plućnih vena), primjena lijekova za liječenje PAH-a, uključujući Opsumit, može izazvati plućni edem.
English: In a placebo-controlled trial in patients with PAH, the efficacy and safety of macitentan in combination with sildenafil were demonstrated.
Croatian: U placebom kontroliranom ispitivanju u bolesnika s PAH-om, dokazana je djelotvornost i sigurnost macitentana u kombinaciji sa sildefanilom.
English: The MAH shall ensure that prior to prescribing all healthcare professionals who intend to prescribe and/or dispense Opsumit are provided with a Prescriber Kit containing the following:
Croatian: Nositelj odobrenja mora osigurati da prije propisivanja lijeka, svi zdravstveni djelatnici za koje se predviđa da će propisivati i/ili izdavati Opsumit dobiju Komplet za propisivača lijeka koji sadrži sljedeće:
English: See section ‘Pregnancy and breastfeeding'.
Croatian: Pogledajte dio 'Trudnoća i dojenje'.
English: Macitentan and its active metabolite are highly bound to plasma proteins (> 99%), primarily to albumin and to a lesser extent to alpha1-acid glycoprotein.
Croatian: Macitentan i njegov aktivni metabolit u velikoj se mjeri vežu za proteine plazme (> 99%), prvenstveno na albumin i u manjoj mjeri na alfa-1 kiseli glikoprotein.
English: Several members of the CYP2C family, namely CYP2C8, CYP2C9 and CYP2C19, as well as CYP3A4, are involved in the formation of these metabolites.
Croatian: Nekoliko članova obitelji CYP2C, kao što su CYP2C8, CYP2C9 i CYP2C19 kao i CYP3A4 uključeni su u nastanak ovih metabolita.
English: Hypospermatogenesis was observed in the life-long carcinogenicity study in rats and in the repeatdose toxicity studies in dogs at exposures that provide safety margins of 9.7 in rats and 23 in dogs.
Croatian: Hipospermatogeneza je uočena u doživotnom ispitivanju kancerogenosti u štakora i ispitivanjima toksičnosti s ponovljenom dozom u pasa pri izloženostima koje pružaju sigurnosne granice od 9,7 u štakora i 23 u pasa.
English: Cases of pulmonary oedema have been reported with vasodilators (mainly prostacyclins) when used in patients with pulmonary veno-occlusive disease.
Croatian: Slučajevi plućnog edema prijavljeni su kod primjene vazodilatatora (uglavnom prostaciklina) kad se koriste u bolesnika s plućnom veno-okluzivnom bolesti.
English: There is limited clinical experience in patients over the age of 75 years.
Croatian: Kliničko iskustvo s bolesnicima starijim od 75 godina je ograničeno.
English: • carbamazepine (used to treat depression and epilepsy),
Croatian: • karbamazepin (za liječenje depresije i epilepsije),
English: The mean treatment duration was 103.9 weeks in the macitentan 10 mg group, and 85.3 weeks in the placebo group.
Croatian: Prosječno trajanje liječenja iznosilo je 103,9 tjedana u skupini koja je primala macitentan 10 mg i 85,3 tjedana u skupini koja je primala placebo.
English: Adverse reactions of headache, nausea, and vomiting were observed.
Croatian: Uočene su nuspojave poput glavobolje, mučnine i povraćanja.
English: Each film-coated tablet contains approximately 37 mg of lactose (as monohydrate) and approximately 0.06 mg of soya bean lecithin (E322).
Croatian: Jedna filmom obložena tableta sadrži 37 mg laktoze (u obliku hidrata) i približno 0,06 mg sojinog lecitina (E322).
English: Reduced efficacy of macitentan in the presence of a potent inducer of CYP3A4 such as rifampicin should be considered.
Croatian: Potrebno je razmotriti smanjenu djelotvornost macitentana u prisutnosti snažnog induktora CYP3A4 poput rifampicina.
English: This corresponded to 3.5 events / 100 patient-years on macitentan 10 mg compared to 2.7 events / 100 patient-years on placebo.
Croatian: To odgovara 3,5 događaja / 100 bolesnik-godina koji su primali 10 mg macitentana u usporedbi s 2,7 događaja / 100 bolesnik-godina koji su primali placebo.
English: • Anaemia (low number of red blood cells) or reduced haemoglobin
Croatian: • anemija (nizak broj crvenih krvnih stanica) ili sniženi hemoglobin
English: Warfarin: Macitentan given as multiple doses of 10 mg once daily had no effect on exposure to S-warfarin (CYP2C9 substrate) or R-warfarin (CYP3A4 substrate) after a single dose of 25 mg warfarin.
Croatian: Varfarin: Macitentan koji se davao u višestrukim dozama od 10 mg jednom dnevno nije imao utjecaja na izloženost S-varfarinu (supstratu CYP2C9) ili R-varfarinu (supstratu CYP3A4) nakon pojedinačne doze od 25 mg varfarina.
English: Oedema, fluid retention3
Croatian: Vrlo često edem, retencija tekućine3
English: If sustained, unexplained, clinically relevant aminotransferase elevations occur, or if elevations are accompanied by an increase in bilirubin > 2 × ULN, or by clinical symptoms of liver injury (e.g., jaundice), Opsumit treatment should be discontinued.
Croatian: U slučaju postojanog, neobjašnjivog, klinički značajnog povišenja razina aminotransferaza ili ako je povišenje popraćeno porastom u razinama bilirubina > 2 x GGN ili kliničkim simptomima oštećenja jetre (primjerice žuticom), potrebno je prekinuti liječenje lijekom Opsumit.
English: Opsumit is a registered trademark of Actelion Pharmaceuticals Ltd
Croatian: Opsumit je registrirani zaštitni robni žig tvrtke Actelion Pharmaceuticals Ltd
English: • To ensure females of childbearing potential are not pregnant and are on reliable contraception prior to starting Opsumit;
Croatian: • Sa sigurnošću utvrditi da žene reproduktivne dobi nisu trudne i da primjenjuju pouzdanu kontracepciju, prije početka primjene lijeka Opsumit;
English: Treatment comparison: macitentan 10 mg vs placebo
Croatian: Usporedba terapija: macitentan 10 mg naspram placeba
English: In the presence of strong CYP3A4 inducers reduced efficacy of macitentan could occur.
Croatian: U prisutnosti jakih induktora CYP3A4 može doći do smanjenja djelotvornosti macitentana.
English: Testicular tubular atrophy, and minimal effects on reproductive variables and sperm morphology were recorded at exposures 3.8-fold the human exposure.
Croatian: Atrofija tubula testisa i minimalni učinci na reproduktivne varijable kao i na morfologiju sperme uočeni su pri izloženosti 3,8 većoj od one kod ljudi.
English: The exposure to the active metabolite in patients, which is approximately 5-fold less potent than macitentan, was approximately 1.3-fold higher than in healthy subjects.
Croatian: Izloženost aktivnom metabolitu, koji je približno 5 puta manje potentan od macitentana, u bolesnika bila je približno 1,3 puta veća nego kod zdravih ispitanika.
English: However, undesirable effects may occur (e.g., headache, hypotension) that may influence the ability to drive and use machines (see section
Croatian: Međutim, mogu se javiti nuspojave (npr. glavobolja, hipotenzija) koje bi mogle utjecati na sposobnost upravljanja vozilima i rada sa strojevima (vidjeti dio 4.8).
English: Page 4 (inside centre)
Croatian: Stranica 4 (sredina unutrašnjosti)
English: Sildenafil: At steady-state, the exposure to sildenafil 20 mg three times a day was increased by 15% during concomitant administration of macitentan 10 mg once daily.
Croatian: Sildenafil: U stanju dinamičke ravnoteže, izloženost sildenafilu od 20 mg tri puta dnevno povećana je za 15% tijekom istovremene primjene macitentana 10 mg jednom dnevno.
English: Based on pharmacokinetic (PK) data, no dose adjustment is required in patients with mild, moderate or severe hepatic impairment (see sections 4.4 and 5.2).
Croatian: Na temelju farmakokinetičkih (PK) podataka, nije potrebna prilagodba doze u bolesnika s blagim, umjerenim ili teškim oštećenjem funkcije jetre (vidjeti dijelove 4.4 i 5.2).
English: • That women of childbearing potential must use reliable contraception;
Croatian: • Žene u reproduktivnoj dobi moraju koristiti pouzdanu kontracepciju;
English: Macitentan and its active metabolite are not relevant substrates of OATP1B1 and OATP1B3, but enter the liver by passive diffusion.
Croatian: Macitentan i njegov aktivni metabolit nisu relevantni supstrati OATP1B1 i OATP1B3, ali ulaze u jetru pasivnom difuzijom.
English: Opsumit widens the pulmonary arteries, making it easier for the heart to pump blood through them.
Croatian: Opsumit širi plućne arterije što olakšava srcu pumpanje krvi kroz njih.
English: Pharmacotherapeutic group: anti-hypertensives, anti-hypertensives for pulmonary arterial hypertension.
Croatian: 5.1 Farmakodinamička svojstva Farmakoterapijska skupina: antihipertenzivi, antihipertenzivi za plućnu arterijsku hipertenziju.
English: How to take Opsumit
Croatian: Kako uzimati Opsumit
English: Leukopenia6
Croatian: Često leukopenija6
English: In the period between end-of-treatment (EOT) and EOS, patients could receive open-label macitentan 10 mg or alternative PAH therapy.
Croatian: U razdoblju između kraja liječenja i dovršetka ispitivanja, bolesnici su mogli primiti otvoreno liječenje macitentanom 10 mg ili zamjensku terapiju za PAH.
English: Macitentan and its active metabolite do not have clinically relevant inhibitory or inducing effects on cytochrome P450 enzymes.
Croatian: Macitentan i njegov aktivni metabolit nemaju klinički značajne inhibitorne ili induktivne učinke na enzime citokroma P450.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Croatian: Ako vam je liječnik rekao da ne podnosite neke šećere, obratite se liječniku prije uzimanja ovog lijeka.
English: • The importance of telling patients to report immediately any possible pregnancy that occurs during Opsumit use.
Croatian: • Važnost upućivanja bolesnice da prijavi svaku moguću trudnoću do koje dođe tijekom primjene lijeka Opsumit.
English: OUTER CARTON/BOTTLE
Croatian: KUTIJA/ BOCA
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Opsumit Lijek čuvajte izvan pogleda i dohvata djece.
English: Exposure to macitentan and its active metabolite was increased by 1.3- and 1.6-fold, respectively, in patients with severe renal impairment.
Croatian: Izloženost macitentanu i njegovom aktivnom metabolitu povećana je za 1,3 odnosno 1,6 puta u bolesnika s teškim oštećenjem funkcije bubrega.
English: In both species there were cardiovascular and mandibular arch fusion abnormalities.
Croatian: U obje vrste uočeni su kardiovaskularni poremećaji te nenormalna fuzija mandibularnog luka.
English: Sildenafil, a CYP3A4 substrate, did not affect the pharmacokinetics of macitentan, while there was a 15% reduction in the exposure to the active metabolite of macitentan.
Croatian: Sildenafil, supstrat CYP3A4, nije utjecao na farmakokinetiku macitentana dok je istovremeno bila prisutna redukcija u izloženosti aktivnom metabolitu od 15%.
English: No dose adjustment is required in patients over the age of 65 years (see section 5.2).
Croatian: U bolesnika starijih od 65 godina nije potrebna prilagodba doze (vidjeti dio 5.2).
English: Macitentan has been administered as a single dose of up to 600 mg to healthy subjects.
Croatian: Macitentan je davan zdravim ispitanicima kao pojedinačna doza do 600 mg.
English: Caution should be exercised when macitentan is administered concomitantly with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, voriconazole, clarithromycin, telithromycin, nefazodone, ritonavir, and saquinavir) (see section 4.5).
Croatian: Potreban je oprez kad se macitentan primjenjuje istovremeno s jakim inhibitorima CYP3A4 (primjerice, s itrakonazolom, ketokonazolom, vorikonazolom, klaritromicinom, telitromicinom, nefazodonom, ritonavirom i sakvinavirom) (vidjeti dio 4.5).
English: Macitentan displays high affinity and sustained occupancy of the ET receptors in human pulmonary arterial smooth muscle cells.
Croatian: Macitentan pokazuje visoki afinitet i održivu zauzetost ET receptora u stanicama glatkih mišića arterija mišića.
English: • To provide patients with appropriate information regarding the safe use of the product;
Croatian: • Bolesnicima dati odgovarajuće informacije o sigurnoj primjeni lijeka;
English: This decrease is not considered clinically relevant (see sections 4.2 and 4.4).
Croatian: Ovo smanjenje nije se smatralo klinički značajnim (vidjeti dijelove 4.2 i 4.4).
English: • nefazodone (used to treat depression),
Croatian: • nefazodon (koristi se za liječenje depresije),
English: White high-density polyethylene (HDPE) bottles with child-resistant closure and a silica gel desiccant.
Croatian: Bijele boce od polietilena visoke gustoće (HDPE) sa zaštitnim zatvaračem sigurnim za djecu i sredstvom za sušenje od silika gela.
English: All events were confirmed by an independent adjudication committee, blinded to treatment allocation.
Croatian: Svi su događaji potvrđeni od strane neovisnog povjerenstva za procjenu koje nije raspolagalo podacima o vrsti terapije koja je dodijeljena pojedinim skupinama bolesnika.
English: It is important that you report immediately to your prescribing doctor pregnancy or any side effects that may occur during treatment with Opsumit.
Croatian: Važno je da svom liječniku koji Vam je propisao lijek odmah prijavite trudnoću ili bilo koju nuspojavu koja se može javiti tijekom liječenja lijekom Opsumit.
English: Opsumit must not be initiated in patients with severe hepatic impairment, or clinically significant elevated hepatic aminotransferases (greater than 3 times the Upper Limit of Normal (> 3 × ULN); see sections 4.3 and
Croatian: Terapija Opsumitom se ne smije započinjati u bolesnika s teškim oštećenjem funkcije jetre ili klinički značajno povišenim jetrenim aminotransferazama (više od 3 puta od gornje granice normale (> 3 × GGN); vidjeti dijelove 4.3 i 4.4).
English: • regular monitoring of haemoglobin levels;
Croatian: • redovitim praćenjem razina hemoglobina;
English: Testicular tubular dilatation was observed in chronic toxicity studies with male rats and dogs with safety margins of 11.6 and 5.8, respectively.
Croatian: Dilatacija tubula testisa uočena je u ispitivanjima kronične toksičnosti kod mužjaka štakora i pasa sa sigurnosnom granicom od 11,6 odnosno 5,8.
English: LIST OF EXCIPIENTS Also contains lactose and soya bean lecithin (E322).
Croatian: 3. POPIS POMOĆNIH TVARI Sadrži također laktozu i sojin lecitin (E322).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg macitentan.
Croatian: 2. KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 10 mg macitentana.
English: Exposure to macitentan in patients with PAH was approximately 1.2-fold greater than in healthy subjects.
Croatian: Izloženost macitentanu u bolesnika s PAH-om bila je približno 1,2 puta veća nego kod zdravih ispitanika.
English: • Pregnancy (see section 4.6).
Croatian: • Dojenje (vidjeti dio 4.6).
English: Haemodynamic parameters were assessed in a subset of patients (placebo [N = 67], macitentan 10 mg [N = 57]) after 6 months of treatment.
Croatian: Hemodinamski parametri procijenjeni su na podskupini bolesnika (placebo [N = 67] te na onima koji su primali macitentan 10 mg [N = 57] nakon 6 mjeseci liječenja.
English: Macitentan may lead to more reduction of blood pressure and decrease in haemoglobin in patients with kidney problems.
Croatian: Macitentan može dovesti do sniženja krvnog tlaka i smanjenja hemoglobina u bolesnika s oštećenjem bubrega.
English: The safety of macitentan in children and adolescents below 18 years has not yet been established.
Croatian: Sigurnost macitentana u djece i adolescenata s nenavršenih 18 godina nisu još ustanovljene.
English: If any of these apply to you, please tell your doctor.
Croatian: Ako se išta od navedenog odnosi na Vas, molimo obavijestite svog liječnika.
English: Each tablet contains 10 mg macitentan.
Croatian: Jedna tableta sadrži 10 mg macitentana.
English: After 2 years of treatment, testicular tubular atrophy was seen in rats at 4-fold the human exposure.
Croatian: 2 godine liječenja, atrofija tubula testisa uočena je u štakora pri 4 puta većoj izloženosti od one kod ljudi.
English: There is no experience with the use of macitentan in patients undergoing dialysis, therefore Opsumit is not recommended in this population (see sections 4.2 and 5.2).
Croatian: Nema iskustva s primjenom macitentana u bolesnika koji su na dijalizi pa se stoga Opsumit ne preporučuje u ovoj populaciji (vidjeti dijelove 4.2 i 5.2).
English: Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III.
Croatian: Opsumit je, kao monoterapija ili u kombinaciji, indiciran za dugotrajno liječenje odraslih bolesnika s plućnom arterijskom hipertenzijom (PAH) klasificiranom prema kriterijima Svjetske zdravstvene organizacije (SZO) kao funkcionalna klasa II do III.
English: Very common side effects (may affect more than 1 in 10 people)
Croatian: Vrlo česte nuspojave (mogu se javiti kod više od 1 na 10 osoba)
English: Based on PK data, no dose adjustment is required in patients with renal impairment.
Croatian: Na temelju PK podataka, nije potrebna prilagodba doze u bolesnika s oštećenjem funkcije bubrega.
English: If you have kidney problems, talk to your doctor before using Opsumit.
Croatian: Ako imate problema s bubrezima, obavijestite svog liječnika prije primjene lijeka Opsumit.
English: 4 Liver aminotransferases
Croatian: Jetrene aminotransferaze
English: • The need for regular blood tests because Opsumit causes a decrease in haemoglobin;
Croatian: • Potreba za redovitim krvnim pretragama, jer Opsumit uzrokuje pad hemoglobina
English: Adverse reactions associated with macitentan obtained from this clinical study are tabulated below.
Croatian: Nuspojave povezane s macitentanom dobivene iz ovih kliničkih ispitivanja navedene su u tablici u nastavku.
English: Macitentan was teratogenic in rabbits and rats at all doses tested.
Croatian: Macitentan se pokazao teratogen u kunića i štakora pri svim ispitanim dozama.
English: Hypersensitivity reactions (e.g., angioedema, pruritus, rash)1
Croatian: Manje često reakcije preosjetljivosti (npr. angioedem, svrbež, osip)1
English: Exposure to macitentan was decreased by 21%, 34%, and 6% and, for the active metabolite by 20%, 25%, and 25% in subjects with mild, moderate or severe hepatic impairment, respectively.
Croatian: Izloženost macitentanu bila je smanjena za 21%, 34% i 6% te za aktivni metabolit za 20%, 25% te za
English: Endothelin (ET)-1 and its receptors (ETA and ETB) mediate a variety of effects such as vasoconstriction, fibrosis, proliferation, hypertrophy, and inflammation.
Croatian: Endotelin (ET)-1 i njegovi receptori (ETA i ETB) posreduju različite učinke poput vazokonstrikcije,
English: Page 5 (inside right)
Croatian: Stranica 5 (unutarnja desna strana)
English: Opsumit is contraindicated during pregnancy and in women of childbearing potential who are not using reliable contraception (see section 4.3).
Croatian: Opsumit je kontraindiciran tijekom trudnoće i kod žena reproduktivne dobi koje ne koriste pouzdanu kontracepciju (vidjeti dio 4.3).
English: Your doctor will take blood test before you start treatment with Opsumit and during treatment to test:
Croatian: Vaš liječnik će provesti krvne pretrage prije početka liječenja lijekom Opsumit i tijekom liječenja kako bi ispitao:
English: Macitentan induced minimal to slight mucosal hyperplasia and inflammatory infiltration in the submucosa of the nasal cavity in the mouse carcinogenicity study at all doses.
Croatian: Macitentan je inducirao minimalnu do blagu hiperplaziju sluznice i upalnu infiltraciju podsluznice nosne šupljine u ispitivanjima kancerogenosti na miševima u svim dozama.
English: The pharmacokinetics of macitentan and its active metabolite have mainly been documented in healthy subjects.
Croatian: 5.2 Farmakokinetička svojstva Farmakokinetika macitentana i njegovog aktivnog metabolita uglavnom je proučavana na zdravim ispitanicima.
English: Elevations > 5 × ULN occurred in 2.5% of patients on macitentan 10 mg versus 2% of patients on placebo.
Croatian: Povišenja > 5 × GGN dogodila su se u 2,5% bolesnika koji su primali macitentan 10 mg naspram 2% bolesnika koji su primali placebo.
English: 2 Hypotension has been associated with the use of ERAs including macitentan.
Croatian: 2 Hipotenzija je povezana s primjenom ERA-ova, uključujući macitentan.
English: - The other ingredients are lactose monohydrate (see section 2 “Opsumit contains lactose, lecithin from soya and sodium"), microcrystalline cellulose (E460i), povidone, sodium starch glycolate Type A (see section 2 “Opsumit contains lactose, lecithin from soya and sodium”), magnesium stearate (E572), polysorbate 80 (E433), polyvinyl alcohol (E1203), titanium dioxide (E171), talc (E553b), soya bean lecithin (E322) (see section 2 “Opsumit contains lactose, lecithin from soya and sodium") and xanthan gum (E415).
Croatian: „Opsumit sadrži laktozu, sojin lecitin i natrij“), magnezijev stearat (E572), polisorbat 80 (E433), poli(vinilni alkohol) (E1203), titanijev dioksid (E171), talk (E553b), sojin lecitin (E322) (vidjeti dio 2 „Opsumit sadrži laktozu, sojin lecitin i natrij“) i ksantanska guma (E415).
English: Opsumit contains lactose.
Croatian: Opsumit sadrži laktozu.