FrancophonIA/ELRC3.0 huggingface dataset:
English: Other adverse reactions with an asterisk in Table 1, section 4.8b are marked based on either their more frequent occurring (by the frequency difference of at least 1%) in the clinical trial data with entacapone than levodopa/DDCI alone or the individual case safety reports received after the introduction of entacapone into the market.
Croatian: Ostale nuspojave sa zvjezdicom u Tablici 1, dijelu 4.8b su označene ili zbog veće učestalosti javljanja (uz razliku u učestalosti od najmanje 1%) u podacima iz kliničkih ispitivanja uz entakapon nego uz samo levodopu/DDC-inhibitor ili zbog sigurnosnih izvješća o pojedinačnom slučaju zaprimljenih nakon uvođenja entakapona na tržište.
English: Consult your doctor if during the treatment with Stalevo you: - notice that your muscles get very rigid or jerk violently, or if you get tremors, agitation, confusion, fever, rapid pulse, or wide fluctuations in your blood pressure.
Croatian: Savjetujte se sa svojim liječnikom ako tijekom liječenja Stalevom: - primijetite da Vam mišići postaju jako ukočeni ili se snažno trzaju, ako se pojavi drhtanje, uznemirenost, smetenost, vrućica, ubrzani puls ili izrazite promjene krvnoga tlaka.
English: Usually Stalevo is to be used in patients who are currently treated with corresponding doses of standard release levodopa/DDC inhibitor and entacapone.
Croatian: Stalevo obično treba koristiti u bolesnika koji se već liječe odgovarajućim dozama levodope/DDCinhibitora sa standardnim oslobađanjem i entakapona.
English: The effects of Stalevo may be weakened by certain medicines.
Croatian: Neki lijekovi mogu oslabiti učinke Staleva.
English: Stalevo is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment.
Croatian: Stalevo je indiciran za liječenje odraslih bolesnika s Parkinsonovom bolešću, kao i za liječenje motoričkih fluktuacija na kraju intervala doziranja koje nisu stabilizirane primjenom levodope/inhibitora dopa dekarboksilaze (DDC).
English: Few adverse reactions are known to be directly attributable to the active substance entacapone including diarrhoea and reddishbrown discolouration of urine.
Croatian: Mali broj nuspojava za koje se zna da su direktno pripisive djelatnoj tvari entakaponu obuhvaća proljev i crvenkasto-smeđu diskoloraciju mokraće.
English: No particular studies on the pharmacokinetics of carbidopa and levodopa in patients with hepatic impairment are reported, however, it is advised that Stalevo should be administered cautiously to patients with mild or moderate hepatic impairment.
Croatian: Nisu objavljena posebna ispitivanja farmakokinetike karbidope i levodope kod bolesnika s oštećenjem jetre, međutim, savjetuje se oprezna primjena Staleva kod bolesnika s blagim ili umjerenim oštećenjem jetre.
English: Patients should be instructed to take only one Stalevo tablet per dose administration.
Croatian: Bolesnike se mora upozoriti da prilikom svake primjene lijeka uzmu samo jednu tabletu Staleva.
English: - If you are taking Stalevo 175 mg/43.75 mg/200 mg tablets, do not take more than 8 tablets of this strength per day.
Croatian: - Ako uzimate Stalevo 175 mg/43,75 mg/200 mg tablete, nemojte uzeti više od 8 tableta dnevno.
English: If you during the treatment with Stalevo experience the following symptoms, contact your doctor immediately: - Your muscles get very rigid or jerk violently, you get tremors, agitation, confusion, fever, rapid pulse, or wide fluctuations in your blood pressure.
Croatian: Ako tijekom liječenja Stalevom imate sljedeće simptome, odmah se javite svom liječniku: - Vaši su mišići postali jako ukočeni ili se snažno trzaju, pojavilo se nevoljno drhtanje, uznemirenost, smetenost, vrućica, ubrzani puls ili izrazite promjene krvnog tlaka.
English: How to store Stalevo
Croatian: Kako čuvati Stalevo
English: - If you are taking Stalevo 200 mg/50 mg/200 mg, do not take more than 7 tablets of this strength per day.
Croatian: - Ako uzimate Stalevo 200 mg/50 mg/200 mg tablete, nemojte uzeti više od 7 tableta dnevno.
English: Uncommon (may affect up to 1 in 100 people) - heart attack - bleeding in the gut - changes in the blood cell count which may result in bleeding, abnormal liver function tests - convulsions - feeling agitated - psychotic symptoms - colitis (inflammation of the colon) - discolourations other than urine (e.g. skin, nail, hair, sweat) - swallowing difficulties - inability to urinate
Croatian: Manje često (može se javiti kod do 1 na 100 osoba) - srčani udar - krvarenje u crijevima - promjene broja krvnih stanica što može dovesti do krvarenja, poremećeni nalazi pretrage jetrene funkcije - konvulzije - osjećaj uznemirenosti - psihotički simptomi - kolitis (upala debelog crijeva) - promjene boje nevezane uz mokraću (npr. koža, nokti, kosa, znoj) - teškoće s gutanjem - nemogućnost mokrenja.
English: You should not breast-feed during treatment with Stalevo.
Croatian: Tijekom liječenja Stalevom ne smijete dojiti.
English: - If you are taking Stalevo 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg,
Croatian: - Ako uzimate Stalevo 50 mg/12,5 mg/200 mg, 75 mg/18,75 mg/200 mg, 100 mg/25 mg/200 mg,
English: However, a longer dosing interval of Stalevo may be considered for patients who are receiving dialysis therapy (see section 4.2).
Croatian: Međutim, treba razmotriti dulji interval doziranja Staleva u bolesnika koji su na dijalizi (vidjeti dio
English: Hepatic impairment: It is advised that Stalevo should be administered cautiously to patients with mild to moderate hepatic impairment.
Croatian: Oštećenje jetre: savjetuje se oprezna primjena Staleva kod bolesnika s blagim do umjerenim oštećenjem jetre.
English: While the experience with total daily dose greater than 200 mg carbidopa is limited, the maximum recommended daily dose of entacapone is 2,000 mg and therefore the maximum dose is 10 tablets per day for the Stalevo strengths of 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg and 150 mg/37.5 mg/200 mg.
Croatian: Kako je iskustvo s ukupnom dnevnom dozom većom od 200 mg karbidope ograničeno, a maksimalna preporučena dnevna doza entakapona je 2000 mg, stoga maksimalna doza Staleva iznosi 10 tableta na dan za jačine od 50 mg/12,5 mg/200 mg, 75 mg/18,75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31,25 mg/200 mg i 150 mg/37,5 mg/200 mg.
English: Rare:
Croatian: Često:
English: Ten tablets of Stalevo 150 mg/37.5 mg/200 mg equals 375 mg of carbidopa a day.
Croatian: Deset tableta Staleva 150 mg/37,5 mg/200 mg odgovara 375 mg karbidope dnevno.
English: Stalevo 50 mg/12.5 mg/200 mg film-coated tablets Stalevo 75 mg/18.75 mg/200 mg film-coated tablets Stalevo 100 mg/25 mg/200 mg film-coated tablets Stalevo 125 mg/31.25 mg/200 mg film-coated tablets Stalevo 150 mg/37.5 mg/200 mg film-coated tablets Stalevo 175 mg/43.75 mg/200 mg film-coated tablets Stalevo 200 mg/50 mg/200 mg film-coated tablets
Croatian: Stalevo 50 mg/12,5 mg/200 mg filmom obložene tablete Stalevo 75 mg/18,75 mg/200 mg filmom obložene tablete Stalevo 100 mg/25 mg/200 mg filmom obložene tablete Stalevo 125 mg/31,25 mg/200 mg filmom obložene tablete Stalevo 150 mg/37,5 mg/200 mg filmom obložene tablete Stalevo 175 mg/43,75 mg/200 mg filmom obložene tablete Stalevo 200 mg/50 mg/200 mg filmom obložene tablete
English: Talk to your doctor or pharmacist before taking Stalevo if you have or have ever had: - a heart attack or any other diseases of the heart including cardiac arrhythmias, or of the blood vessels - asthma or any other disease of the lungs - a liver problem, because your dose may need to be adjusted - kidney or hormone-related diseases
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Stalevo ako imate ili ste ikada imali: - srčani udar ili bilo koju drugu bolest srca uključujući srčane aritmije, ili bolest krvnih žila - astmu ili bilo koju drugu bolest pluća, - probleme s jetrom, jer tada Vašu dozu možda treba prilagoditi, - bolesti povezane s bubrezima ili hormonima,
English: - The active substances of Stalevo are levodopa, carbidopa and entacapone.
Croatian: Staleva su levodopa, karbidopa i entakapon.
English: According to this daily carbidopa dose, the maximum recommended daily dose of Stalevo 175 mg/43.75 mg/200 mg is 8 tablets per day and Stalevo 200 mg/50 mg/200 mg dose is 7 tablets per day.
Croatian: najviša preporučena dnevna doza Staleva 175 mg/43,75 mg/200 mg je 8 tableta na dan, a Staleva 200 mg/50 mg/200 mg je 7 tableta na dan.
English: 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg or 150 mg/37.5 mg/200 mg tablets, do not take more than 10 tablets per day.
Croatian: 125 mg/31,25 mg/200 mg ili 150 mg/37,5 mg/200 mg tablete ne smijete uzeti više od 10 tableta na dan.
English: - Dopamine Dysregulation Syndrome (DDS) is an addictive disorder resulting in excessive use of the product seen in some patients treated with carbidopa/levodopa.
Croatian: Dopamine Dysregulation Syndrome, DDS) je poremećaj s ovisničkim obrascem ponašanja koji dovodi do prekomjerne primjene lijeka, a primijećen je u nekih bolesnika liječenih karbidopom/levodopom.
English: b. When initiating Stalevo therapy for patients currently treated with entacapone and levodopa/carbidopa in doses not equal to Stalevo tablets (50 mg/12.5 mg/200 mg or 75 mg/18.75 mg/200 mg or 100 mg/25 mg/200 mg or 125 mg/31.25 mg/200 mg or 150 mg/37.5 mg/200 mg or 175 mg/43.75 mg/200 mg or 200 mg/50 mg/200 mg), Stalevo dosing should be carefully titrated for optimal clinical response.
Croatian: Kada se terapija Stalevom uvodi bolesnicima koji su trenutno liječeni entakaponom i levodopom/karbidopom u dozama koje ne odgovaraju Stalevo tabletama (50 mg/12,5 mg/200 mg ili 75 mg/18,75 mg/200 mg ili 100 mg/25 mg/200 mg ili 125 mg/31,25 mg/200 mg ili 150 mg/37,5 mg/200 mg ili 175 mg/43,75 mg/200 mg ili 200 mg/50 mg/200 mg), doziranje Staleva mora biti pažljivo titrirano radi optimalnog kliničkog odgovora.
English: Stalevo contains sucrose
Croatian: Stalevo sadrži saharozu
English: stalevo 75/18.75/200 mg [carton only]
Croatian: stalevo 75/18,75/200 mg [samo kutija]
English: stalevo 125/31.25/200 mg [carton only]
Croatian: stalevo 125/31,25/200 mg [samo kutija]
English: Tel: +386 (0) 1 600 8015
Croatian: Orion Pharma d.o.o. Tel: +386 (0) 1 600 8015
English: stalevo 175/43.75/200 mg [carton only]
Croatian: stalevo 175/43,75/200 mg [samo kutija]
English: stalevo 100/25/200 mg [carton only]
Croatian: stalevo 100/25/200 mg [samo kutija]
English: stalevo 150/37.5/200 mg [carton only]
Croatian: stalevo 150/37,5/200 mg [samo kutija]
English: stalevo 50/12.5/200 mg [carton only]
Croatian: stalevo 50/12,5/200 mg [samo kutija]
English: stalevo 200/50/200 mg [carton only]
Croatian: stalevo 200/50/200 mg [samo kutija]
English: - Periodic evaluation of hepatic, haematopoietic, cardiovascular and renal function is recommended during extended therapy with Stalevo.
Croatian: - Tijekom produžene terapije Stalevom preporučuje se povremeno pratiti jetrene, hematopoetske, kardiovaskularne i bubrežne funkcije.
English: Stalevo contains sucrose (2.3 mg/tablet).
Croatian: Stalevo sadrži saharozu (2,3 mg/tableti).
English: Stalevo contains sucrose (1.89 mg/tablet).
Croatian: Stalevo sadrži saharozu (1,89 mg/tableti).
English: Stalevo 150 mg/37.5 mg/200 mg: brownish or greyish red, elongated-ellipse shaped, unscored filmcoated tablets marked with ‘LCE 150' on one side.
Croatian: Stalevo 150 mg/37,5 mg/200 mg: smećkasto- ili sivkasto-crvene, izdužene filmom obložene tablete u obliku elipse, bez ureza, s oznakom "LCE 150" na jednoj strani.
English: Stalevo 75 mg/18.75 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Croatian: Stalevo 75 mg/18,75 mg/200 mg tablete dolazi u pet različitih veličina pakiranja (10, 30, 100, 130, ili 175 tableta).
English: Stalevo 125 mg/31.25 mg/200 mg: light brownish red, oval film-coated tablets marked with ‘LCE 125' on one side.
Croatian: Stalevo 125 mg/31,25 mg/200 mg: svijetlo smećkasto-crvene, ovalne filmom obložene tablete, s oznakom "LCE 125" na jednoj strani.
English: Stalevo 175 mg/43.75 mg/200 mg: light brownish red, oval, unscored film-coated tablets marked with ‘LCE 175' on one side.
Croatian: Stalevo 175 mg/43,75 mg/200 mg: svijetlo smećkasto-crvene, ovalne filmom obložene tablete, bez ureza, s oznakom "LCE 175" na jednoj strani.
English: Stalevo 75 mg/18.75 mg/200 mg: light brownish red, oval film-coated tablets marked with ‘LCE 75' on one side.
Croatian: Stalevo 75 mg/18,75 mg/200 mg: svijetlo smećkasto-crvene, ovalne filmom obložene tablete, s oznakom "LCE 75" na jednoj strani.
English: Serious events of gastrointestinal haemorrhage (uncommon) and angioedema (rare) have been identified from the clinical trials with Stalevo or entacapone combined with levodopa/DDC inhibitor.
Croatian: U kliničkim ispitivanjima sa Stalevom ili entakaponom u kombinaciji s levodopom/DDCinhibitorom otkriveni su ozbiljni događaji gastrointestinalnog krvarenja (manje često) i angioedema (rijetko).
English: Stalevo 125 mg/31.25 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Croatian: Stalevo 125 mg/31,25 mg/200 mg tablete dolazi u pet različitih veličina pakiranja (10, 30, 100, 130, ili 175 tableta).
English: Stalevo 75 mg/18.75 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Croatian: Stalevo 75 mg/18,75 mg/200 mg filmom obložene tablete levodopa/karbidopa/entakapon
English: How to transfer patients taking levodopa/DDC inhibitor (carbidopa or benserazide) preparations and entacapone tablets to Stalevo a. Patients who are currently treated with entacapone and with standard release levodopa/carbidopa in doses equal to Stalevo tablet strengths can be directly transferred to corresponding Stalevo tablets.
Croatian: Kako na Stalevo prebaciti bolesnike koji primaju preparate levodope/DDC-inhibitora (karbidopa ili benzerazid) i entakapon tablete a.
English: - Each Stalevo 125 mg/31.25 mg/200 mg tablet contains 125 mg of levodopa, 31.25 mg of carbidopa and 200 mg of entacapone.
Croatian: - Jedna Stalevo 125 mg/31,25 mg/200 mg tableta sadrži 125 mg levodope, 31,25 mg karbidope i 200 mg entakapona.
English: Stalevo 200 mg/50 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175).
Croatian: Stalevo 200 mg/50 mg/200 mg tablete dolazi u pet različitih veličina pakiranja (10, 30, 100, 130, ili 175 tableta).
English: Stalevo 175 mg/43.75 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Croatian: Stalevo 175 mg/43,75 mg/200 mg tablete dolazi u pet različitih veličina pakiranja (10, 30, 100, 130, ili 175 tableta).
English: Stalevo contains sucrose (1.9 mg/tablet).
Croatian: Stalevo sadrži saharozu (1,9 mg/tableti).
English: Initiation of Stalevo may be considered at corresponding doses to current treatment in some patients with Parkinson's disease and end-of-dose motor fluctuations, who are not stabilised on their current standard release levodopa/DDC inhibitor treatment.
Croatian: U nekih bolesnika s Parkinsonovom bolešću i motoričkim fluktuacijama na kraju intervala doziranja, koji nisu stabilizirani trenutnim liječenjem levodopom/DDC-inhibitorom sa standardnim oslobađanjem, može se razmotriti uvođenje Staleva u dozama odgovarajućim trenutnoj terapiji.
English: Stalevo 200 mg/50 mg/200 mg: dark brownish red, oval, unscored film-coated tablets marked with ‘LCE 200' on one side.
Croatian: Stalevo 200 mg/50 mg/200 mg: tamno smećkasto-crvene, ovalne filmom obložene tablete, bez ureza, s oznakom "LCE 200" na jednoj strani.
English: Stalevo 50 mg/12.5 mg/200 mg: brownish or greyish red, round, convex unscored film-coated tablets marked with ‘LCE 50' on one side.
Croatian: Stalevo 50 mg/12,5 mg/200 mg: smećkasto ili sivkasto-crvene, okrugle, konveksne filmom obložene tablete, bez ureza, s oznakom "LCE 50" na jednoj strani.
English: Stalevo 100 mg/25 mg/200 mg: brownish or greyish red, oval, unscored film-coated tablets marked with ‘LCE 100' on one side.
Croatian: Stalevo 100 mg/25 mg/200 mg: smećkasto ili sivkasto-crvene, ovalne filmom obložene tablete, bez ureza, s oznakom "LCE 100" na jednoj strani.
English: - Each Stalevo 175 mg/43.75 mg/200 mg tablet contains 175 mg of levodopa, 43.75 mg of carbidopa and 200 mg of entacapone.
Croatian: - Jedna Stalevo 175 mg/43,75 mg/200 mg tableta sadrži 175 mg levodope, 43,75 mg karbidope i 200 mg entakapona.
English: - Each Stalevo 75 mg/18.75 mg/200 mg tablet contains 75 mg of levodopa, 18.75 mg of carbidopa and 200 mg of entacapone.
Croatian: - Jedna Stalevo 75 mg/18,75 mg/200 mg tableta sadrži 75 mg levodope, 18,75 mg karbidope i 200 mg entakapona.
English: - Each Stalevo 100 mg/25 mg/200 mg tablet contains 100 mg of levodopa, 25 mg of carbidopa and 200 mg of entacapone.
Croatian: - Jedna Stalevo 100 mg/25 mg/200 mg tableta sadrži 100 mg levodope, 25 mg karbidope i 200 mg entakapona.
English: Stalevo contains sucrose (1.6 mg/tablet).
Croatian: Stalevo sadrži saharozu (1,6 mg/tableti).
English: - Each Stalevo 150 mg/37.5 mg/200 mg tablet contains 150 mg of levodopa, 37.5 mg of carbidopa and 200 mg of entacapone.
Croatian: - Jedna Stalevo 150 mg/37,5 mg/200 mg tableta sadrži 150 mg levodope, 37,5 mg karbidope i 200 mg entakapona.
English: Stalevo contains sucrose (1.2 mg/tablet).
Croatian: Stalevo sadrži saharozu (1,2 mg/tableti).
English: - Each Stalevo 50 mg/12.5 mg/200 mg tablet contains 50 mg of levodopa, 12.5 mg of carbidopa and 200 mg of entacapone.
Croatian: - Jedna Stalevo 50 mg/12,5 mg/200 mg tableta sadrži 50 mg levodope, 12,5 mg karbidope i 200 mg entakapona.
English: Stalevo 175 mg/43.75 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Croatian: Stalevo 175 mg/43,75 mg/200 mg filmom obložene tablete levodopa/karbidopa/entakapon
English: Some patients experience severe abnormal involuntary movements (dyskinesias), mood swings or other side effects after taking large doses of Stalevo.
Croatian: U nekih se bolesnika nakon uzimanja velikih doza lijeka Stalevo javljaju vrlo izražene neuobičajene nevoljne kretnje (diskinezije), promjene raspoloženja ili druge nuspojave.
English: Stalevo contains sucrose (1.4 mg/tablet).
Croatian: Stalevo sadrži saharozu (1,4 mg/tableti).
English: Stalevo 50 mg/12.5 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Croatian: Stalevo 50 mg/12,5 mg/200 mg filmom obložene tablete levodopa/karbidopa/entakapon
English: Tel: + 39 02 67876111
Croatian: Orion Pharma S.r.l. Tel: + 39 02 67876111
English: Stalevo 100 mg/25 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Croatian: Stalevo 100 mg/25 mg/200 mg filmom obložene tablete levodopa/karbidopa/entakapon
English: Stalevo 150 mg/37.5 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Croatian: Stalevo 150 mg/37,5 mg/200 mg filmom obložene tablete levodopa/karbidopa/entakapon
English: - Each Stalevo 200 mg/50 mg/200 mg tablet contains 200 mg of levodopa, 50 mg of carbidopa and 200 mg of entacapone.
Croatian: - Jedna Stalevo 200 mg/50 mg/200 mg tableta sadrži 200 mg levodope, 50 mg karbidope i 200 mg entakapona.
English: Stalevo 125 mg/31.25 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Croatian: Stalevo 125 mg/31,25 mg/200 mg filmom obložene tablete levodopa/karbidopa/entakapon
English: EU/1/03/260/024 10 film-coated tablets EU/1/03/260/025 30 film-coated tablets EU/1/03/260/026 100 film-coated tablets EU/1/03/260/027 130 film-coated tablets EU/1/03/260/028 175 film-coated tablets
Croatian: EU/1/03/260/024 10 filmom obloženih tableta EU/1/03/260/025 30 filmom obloženih tableta EU/1/03/260/026 100 filmom obloženih tableta EU/1/03/260/027 130 filmom obloženih tableta EU/1/03/260/028 175 filmom obloženih tableta
English: Stalevo 200 mg/50 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Croatian: Stalevo 200 mg/50 mg/200 mg filmom obložene tablete levodopa/karbidopa/entakapon
English: The doses of other antiparkinsonian medicinal products may need to be adjusted when Stalevo treatment is substituted for a patient currently not treated with entacapone.
Croatian: Kod prelaska liječenja na Stalevo u bolesnika koji se trenutno ne liječe entakaponom, može biti potrebno prilagoditi doze drugih antiparkinsonika.
English: - The ingredients in the film-coating are glycerol (85 per cent) (E422), hypromellose, magnesium stearate, polysorbate 80, red iron oxide (E172), sucrose and titanium dioxide (E171).
Croatian: - Drugi sastojci u ovojnici tablete su glicerol (85-postotni) (E422), hipromeloza, magnezijev stearat, polisorbat 80, željezov oksid crveni (E172), saharoza, titanijev dioksid (E171).
English: EU/1/03/260/029 10 film-coated tablets EU/1/03/260/030 30 film-coated tablets EU/1/03/260/031 100 film-coated tablets EU/1/03/260/032 130 film-coated tablets EU/1/03/260/033 175 film-coated tablets
Croatian: EU/1/03/260/029 10 filmom obloženih tableta EU/1/03/260/030 30 filmom obloženih tableta EU/1/03/260/031 100 filmom obloženih tableta EU/1/03/260/032 130 filmom obloženih tableta EU/1/03/260/033 175 filmom obloženih tableta
English: EU/1/03/260/034 10 film-coated tablets EU/1/03/260/035 30 film-coated tablets EU/1/03/260/036 100 film-coated tablets EU/1/03/260/037 130 film-coated tablets EU/1/03/260/038 175 film-coated tablets
Croatian: EU/1/03/260/034 10 filmom obloženih tableta EU/1/03/260/035 30 filmom obloženih tableta EU/1/03/260/036 100 filmom obloženih tableta EU/1/03/260/037 130 filmom obloženih tableta EU/1/03/260/038 175 filmom obloženih tableta
English: Tel: + 34 91 599 86 01
Croatian: Orion Pharma S.L. Tel: + 34 91 599 86 01
English: EU/1/03/260/005 10 film-coated tablets EU/1/03/260/006 30 film-coated tablets EU/1/03/260/007 100 film-coated tablets EU/1/03/260/008 250 film-coated tablets EU/1/03/260/014 175 film-coated tablets EU/1/03/260/017 130 film-coated tablets
Croatian: EU/1/03/260/005 10 filmom obloženih tableta EU/1/03/260/006 30 filmom obloženih tableta EU/1/03/260/007 100 filmom obloženih tableta EU/1/03/260/008 250 filmom obloženih tableta EU/1/03/260/014 175 filmom obloženih tableta EU/1/03/260/017 130 filmom obloženih tableta
English: EU/1/03/260/009 10 film-coated tablets EU/1/03/260/010 30 film-coated tablets EU/1/03/260/011 100 film-coated tablets EU/1/03/260/012 250 film-coated tablets EU/1/03/260/015 175 film-coated tablets EU/1/03/260/018 130 film-coated tablets
Croatian: EU/1/03/260/009 10 filmom obloženih tableta EU/1/03/260/010 30 filmom obloženih tableta EU/1/03/260/011 100 filmom obloženih tableta EU/1/03/260/012 250 filmom obloženih tableta EU/1/03/260/015 175 filmom obloženih tableta EU/1/03/260/018 130 filmom obloženih tableta
English: Film-coating of 50/12.5/200 mg, 100/25/200 mg and 150/37.5/200 mg: Glycerol (85 per cent) (E422)
Croatian: Film ovojnica za 50/12,5/200 mg, 100/25/200 mg i 150/37,5/200 mg: glicerol (85-postotni) (E422) hipromeloza magnezijev stearat polisorbat 80 željezov oksid, crveni (E172) saharoza titanijev dioksid (E171) željezov oksid, žuti (E172)
English: EU/1/03/260/019 10 film-coated tablets EU/1/03/260/020 30 film-coated tablets EU/1/03/260/021 100 film-coated tablets EU/1/03/260/022 130 film-coated tablets EU/1/03/260/023 175 film-coated tablets
Croatian: EU/1/03/260/019 10 filmom obloženih tableta EU/1/03/260/020 30 filmom obloženih tableta EU/1/03/260/021 100 filmom obloženih tableta EU/1/03/260/022 130 filmom obloženih tableta EU/1/03/260/023 175 filmom obloženih tableta
English: - The ingredients in the film-coating are glycerol (85 per cent) (E422), hypromellose, magnesium stearate, polysorbate 80, red iron oxide (E172), sucrose, titanium dioxide (E171), and yellow iron oxide (E172).
Croatian: - Drugi sastojci u ovojnici tablete su glicerol (85-postotni) (E 422), hipromeloza, magnezijev stearat, polisorbat 80, crveni željezov oksid (E 172), saharoza, titanijev dioksid (E 171) i žuti željezov oksid(E 172).
English: EU/1/03/260/001 10 film-coated tablets EU/1/03/260/002 30 film-coated tablets EU/1/03/260/003 100 film-coated tablets EU/1/03/260/004 250 film-coated tablets EU/1/03/260/013 175 film-coated tablets EU/1/03/260/016 130 film-coated tablets
Croatian: EU/1/03/260/001 10 filmom obloženih tableta EU/1/03/260/002 30 filmom obloženih tableta EU/1/03/260/003 100 filmom obloženih tableta EU/1/03/260/004 250 filmom obloženih tableta EU/1/03/260/013 175 filmom obloženih tableta EU/1/03/260/016 130 filmom obloženih tableta