natgillin/translations-raw huggingface dataset:
A syndrome resembling the neuroleptic malignant syndrome including muscular rigidity, elevated body temperature, mental changes and increased serum creatine phosphokinase has been reported with the abrupt withdrawal of antiparkinsonian agents.
Prilikom naglog prekida uzimanja antiparkinsonika zabilježen je sindrom sličan neuroleptičkom malignom sindromu uključujući mišićnu rigidnost, povišenu tjelesnu temperaturu, mentalne promjene i povišenu kreatin fosfokinazu u serumu.
Serious hepatitis with mainly cholestatic features, rhabdomyolysis and neuroleptic malignant syndrome may occur with Levodopa/Carbidopa/Entacapone Orion although no cases have been identified from the clinical trial data.
Ozbiljni hepatitis s uglavnom kolestatskim obilježjima, rabdomioliza i neuroleptički maligni sindrom mogu se javiti uz Levodopa/Carbidopa/Entacapone
- If you are taking Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg, do not take more than 7 tablets of this strength per day.
- Ako uzimate Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg tablete, nemojte uzeti više od 7 tableta dnevno.
Antidepressants: Rarely, reactions including hypertension and dyskinesia have been reported with the concomitant use of tricyclic antidepressants and levodopa/carbidopa.
Antidepresivi: s istodobnom primjenom tricikličkih antidepresiva i levodope/karbidope rijetko su zabilježene reakcije koje uključuju hipertenziju i diskineziju.
If therapy has to be stopped temporarily, Levodopa/Carbidopa/Entacapone Orion may be restarted as soon as oral medicinal products can be taken at the same daily dose as before.
Oriona može se ponovno započeti čim se mogu uzimati oralni lijekovi uz isto dnevno doziranje kao i prije.
If you suddenly stop taking Levodopa/Carbidopa/Entacapone Orion and other antiparkinsonian medicines it may result in unwanted side effects.
Naglo ukidanje Levodopa/Carbidopa/Entacapone Oriona i drugih antiparkinsonika može rezultirati neželjenim nuspojavama.
Talk to your doctor or pharmacist before taking Levodopa/Carbidopa/Entacapone Orion 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
Orion 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,
- The other ingredients in the tablet core are croscarmellose sodium, magnesium stearate, maize starch, mannitol (E421) and povidone (E1201).
- Drugi sastojci u jezgri tablete su umrežena karmelozanatrij, magnezijev stearat, kukuruzni škrob, manitol (E421) i povidon (E1201).
Therefore Levodopa/Carbidopa/Entacapone Orion should be given cautiously to patients who are taking other medicinal products which may cause orthostatic hypotension.
Orion treba oprezno davati bolesnicima koji uzimaju druge lijekove koji mogu prouzročiti ortostatsku hipotenziju.
For example, a patient taking one tablet of 50 mg/12.5 mg of levodopa/carbidopa with one tablet of entacapone 200 mg four times daily can take one 50 mg/12.5 mg/200 mg Levodopa/Carbidopa/Entacapone Orion tablet four times daily in place of their usual levodopa/carbidopa and entacapone doses.
Na primjer, bolesnik koji uzima jednu tabletu od 50 mg/12,5 mg levodope/karbidope s jednom tabletom entakapona 200 mg četiri puta dnevno može uzeti jednu Levodopa/Carbidopa/Entacapone
What Levodopa/Carbidopa/Entacapone Orion is and what it is used for What you need to know before you take Levodopa/Carbidopa/Entacapone Orion How to take Levodopa/Carbidopa/Entacapone Orion Possible side effects
Orion i za što se koristi Što morate znati prije nego počnete uzimati Levodopa/Carbidopa/Entacapone Orion Kako uzimati Levodopa/Carbidopa/Entacapone Orion Moguće nuspojave
c. When initiating Levodopa/Carbidopa/Entacapone Orion in patients currently treated with entacapone and levodopa/benserazide in a standard release formulation, the dosing of levodopa/benserazide should be discontinued in the previous night, and Levodopa/Carbidopa/Entacapone Orion should be started in the next morning.
Orion uvodi bolesnicima koji su trenutno liječeni entakaponom i formulacijom sa standardnim oslobađanjem levodope/benzerazida, potrebno je prekinuti doziranje levodope/benzerazida noć prije i započeti sa Levodopa/Carbidopa/Entacapone
Urticaria*
Urtikarija*
Women should not breast-feed during treatment with Levodopa/Carbidopa/Entacapone Orion.
Žene ne smiju dojiti tijekom liječenja Levodopa/Carbidopa/Entacapone Orionom.
Label 10 tablets 30 tablets 100 tablets 130 tablets 175 tablets
Naljepnica 10 tableta 30 tableta 100 tableta 130 tableta 175 tableta
Levodopa/Carbidopa/Entacapone Orion 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.
Orion 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).
Pack sizes of 75/18.75/200 mg, 125/31.25/200 mg, 175/43.75/200 mg and 200/50/200 mg: 10, 30, 100, 130 and 175 tablets.
Veličine pakiranja za 75/18,75/200 mg, 125/31,25/200 mg, 175/43,75/200 mg i 200/50/200 mg: 10, 30, 100, 130 i 175 tableta.
5 How to store Levodopa/Carbidopa/Entacapone Orion Contents of the pack and other information
Kako čuvati Levodopa/Carbidopa/Entacapone Orion Sadržaj pakiranja i druge informacije
Elderly: No dose adjustment of Levodopa/Carbidopa/Entacapone Orion is required for elderly.
Starije osobe: starijim osobama nije potrebno prilagođavati dozu Levodopa/Carbidopa/Entacapone Oriona.
Label 10 tablets 30 tablets 100 tablets 130 tablets 175 tablets 250 tablets
Naljepnica 10 tableta 30 tableta 100 tableta 130 tableta 175 tableta 250 tableta
The daily dose should be preferably optimised using one of the seven available tablet strengths (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, 150 mg/37.5 mg/200 mg, 175 mg/43.75 mg/200 mg or 200 mg/50 mg/200 mg levodopa/carbidopa/entacapone).
Dnevna doza treba se optimalno postići korištenjem jedne od sedam jačina tableta koje su na raspolaganju (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, 150 mg/37,5 mg/200 mg, 175 mg/43,75 mg/200 mg ili 200 mg/50 mg/200 mg levodope/karbidope/entakapona).
- Dopamine Dysregulation Syndrome (DDS) is an addictive disorder resulting in excessive use of the product seen in some patients treated with carbidopa/levodopa.
Dopamine Dysregulation Syndrome, DDS) je poremećaj s ovisnosničkim obrascem ponašanja koji dovodi do prekomjerne primjene lijeka, a primijećen je u nekih bolesnika liječenih karbidopom/levodopom.
What you need to know before you take Levodopa/Carbidopa/Entacapone Orion
Što morate znati prije nego počnete uzimati Levodopa/Carbidopa/Entacapone Orion
The following adverse reactions, listed in Table 1, have been accumulated both from a pooled data of eleven double-blind clinical trials consisting of 3230 patients (1810 treated with Levodopa/Carbidopa/Entacapone Orion or entacapone combined with levodopa/DDC inhibitor, and 1420 treated with placebo combined with levodopa/DDC inhibitor or cabergoline combined with levodopa/ DDC inhibitor), and from the post-marketing data since the introduction of entacapone into the market for the combination use of entacapone with levodopa/DDC inhibitor.
Orionom ili entakaponom u kombinaciji s levodopom/DDCinhibitorom, i 1420 liječenih placebom u kombinaciji s levodopom/DDC-inhibitorom ili kabergolinom u kombinaciji s levodopom/DDC-inhibitorom) i iz podataka dobivenih nakon stavljanja entakapona na tržište za njegovu kombiniranu primjenu s levodopom/DDC-inhibitorom.
When considered necessary, the replacement of Levodopa/Carbidopa/Entacapone Orion with levodopa and DDC inhibitor without entacapone or other dopaminergic treatment should proceed slowly and an increase in levodopa dose may be necessary.
Oriona levodopom i DDC-inhibitorom bez entakapona ili drugim dopaminergičkim liječenjem treba se odvijati polako te može biti potrebno povećanje doziranja levodope.
- Rhabdomyolysis secondary to severe dyskinesias or neuroleptic malignant syndrome (NMS) has been observed rarely in patients with Parkinson's disease.
- U bolesnika s Parkinsonovom bolešću rijetko je opažena rabdomioliza uslijed teških diskinezija ili neuroleptičkog malignog sindroma (NMS).
Dopamine Dysregulation Syndrome (DDS) is an addictive disorder seen in some patients treated with carbidopa/levodopa.
Sindrom poremećene regulacije dopamina je poremećaj s ovisničkim obrascem ponašanja primijećen u nekih bolesnika liječenih karbidopom/levodopom.
Usually Levodopa/Carbidopa/Entacapone Orion is to be used in patients who are currently treated with corresponding doses of standard release levodopa/DDC inhibitor and entacapone.
Orion obično treba koristiti u bolesnika koji se već liječe odgovarajućim dozama levodope/DDC-inhibitora sa standardnim oslobađanjem i entakapona.
At the initiation, Levodopa/Carbidopa/Entacapone Orion should be adjusted to correspond as closely as possible to the total daily dose of levodopa currently used.
Oriona da bi ona bila što je moguće bliža ukupnoj dnevnoj dozi levodope koja se trenutno koristi.
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
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.
Film-coating of 50/12.5/200 mg, 100/25/200 mg and 150/37.5/200 mg: Glycerol (85 per cent) (E422)
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
However, a direct switch from levodopa/DDC inhibitor to Levodopa/Carbidopa/Entacapone Orion is not recommended for patients who have dyskinesias or whose daily levodopa dose is above 800 mg.
Orion ne preporučuje se za bolesnike koji imaju diskinezije ili čija je dnevna doza levodope iznad 800 mg.
10 film-coated tablets 30 film-coated tablets 100 film-coated tablets 130 film-coated tablets 175 film-coated tablets 250 film-coated tablets
10 filmom obloženih tableta 30 filmom obloženih tableta 100 filmom obloženih tableta 130 filmom obloženih tableta 175 filmom obloženih tableta 250 filmom obloženih tableta
b. When initiating Levodopa/Carbidopa/Entacapone Orion therapy for patients currently treated with entacapone and levodopa/carbidopa in doses not equal to Levodopa/Carbidopa/Entacapone Orion 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), Levodopa/Carbidopa/Entacapone Orion dosing should be carefully titrated for optimal clinical response.
Orionom uvodi bolesnicima koji su trenutno liječeni entakaponom i levodopom/karbidopom u dozama koje ne odgovaraju Levodopa/Carbidopa/Entacapone Orion 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 Levodopa/Carbidopa/Entacapone
No particular studies on the pharmacokinetics of carbidopa and levodopa in patients with hepatic impairment are reported, however, it is advised that Levodopa/Carbidopa/Entacapone Orion should be administered cautiously to patients with mild or moderate hepatic impairment.
Nisu objavljena posebna ispitivanja farmakokinetike karbidope i levodope kod bolesnika s oštećenjem jetre, međutim, savjetuje se oprezna primjena Levodopa/Carbidopa/Entacapone
Other medicines and Levodopa/Carbidopa/Entacapone Orion
Drugi lijekovi i Levodopa/Carbidopa/Entacapone Orion
- Patients with chronic wide-angle glaucoma may be treated with Levodopa/Carbidopa/Entacapone Orion with caution, provided the intra-ocular pressure is well controlled and the patient is monitored carefully for changes in intra-ocular pressure.
Orionom pod uvjetom da je intraokularni tlak dobro kontroliran i da se bolesnike pažljivo prati zbog promjena intraokularnog tlaka.
10 film-coated tablets 30 film-coated tablets 100 film-coated tablets 130 film-coated tablets 175 film-coated tablets
10 filmom obloženih tableta 30 filmom obloženih tableta 100 filmom obloženih tableta 130 filmom obloženih tableta 175 filmom obloženih tableta
Levodopa/Carbidopa/Entacapone Orion may lower your blood pressure, which may make you feel light-headed or dizzy.
Orion može sniziti krvni tlak, zbog čega možete osjetiti ošamućenost ili omaglicu.
Cardiac disorders Common:
Srčani poremećaji Često:
Brownish or greyish red, round, convex, unscored film-coated tablets marked with ‘LCE 50' on one side.
Smećkasto ili sivkasto-crvene, okrugle, konveksne filmom obložene tablete, bez ureza, s oznakom "LCE 50" na jednoj strani.
The effects of Levodopa/Carbidopa/Entacapone Orion may be weakened by certain medicines.
Neki lijekovi mogu oslabiti učinke Levodopa/Carbidopa/Entacapone Oriona.
Brownish or greyish red, elongated-ellipse shaped, unscored film-coated tablets marked with ‘LCE 150' on one side.
Smećkaste ili sivkasto-crvene, izdužene filmom obložene tablete u obliku elipse, bez ureza, s oznakom "LCE 150" na jednoj strani.
Other forms of interactions: Since levodopa competes with certain amino acids, the absorption of Levodopa/Carbidopa/Entacapone Orion may be impaired in some patients on high protein diet.
Ostali oblici interakcija: budući da se levodopa natječe s određenim aminokiselinama, apsorpcija Levodopa/Carbidopa/Entacapone
Craving for large doses of Levodopa/Carbidopa/Entacapone Orion in excess of that required to control motor symptoms, known as dopamine dysregulation syndrome.
Orion, koje su veće od onih potrebnih za kontrolu motoričkih simptoma, što je poznato kao sindrom poremećene regulacije dopamina.
Orthostatic hypotension, hypertension
Ortostatska hipotenzija, hipertenzija Manje često: Gastrointestinalno krvarenje
If you stop taking Levodopa/Carbidopa/Entacapone Orion
Ako prestanete uzimati Levodopa/Carbidopa/Entacapone Orion
125 mg/31.25 mg/200 mg Light brownish red, oval film-coated tablets marked with ‘LCE 125' on one side.
125 mg/31,25 mg/200 mg Svijetlo smećkasto-crvene, ovalne filmom obložene tablete, s oznakom "LCE 125" na jednoj strani.
When less levodopa is required, the total daily dose of Levodopa/Carbidopa/Entacapone Orion should be reduced either by decreasing the frequency of administration by extending the time between doses, or by decreasing the strength of Levodopa/Carbidopa/Entacapone Orion at an administration.
Oriona mora se smanjiti ili smanjenjem učestalosti primjene povećanjem vremenskog razmaka između doza ili primjenom manje jačine Levodopa/Carbidopa/Entacapone Oriona.
Due to entacapone's affinity to cytochrome P450 2C9 in vitro (see section 5.2), Levodopa/Carbidopa/Entacapone Orion may potentially interfere with active substances whose metabolism is dependent on this isoenzyme, such as S-warfarin.
Zbog afiniteta entakapona prema citokromu P450 2C9 in vitro (vidjeti dio 5.2), Levodopa/Carbidopa/Entacapone
- Each Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg tablet contains 200 mg of levodopa, 50 mg of carbidopa and 200 mg of entacapone.
- Jedna Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg tableta sadrži 200 mg levodope, 50 mg karbidope i 200 mg entakapona.
Neither NMS nor rhabdomyolysis have been reported in association with entacapone treatment from controlled trials in which entacapone was discontinued abruptly.
U kontroliranim studijama u kojima je primjena entakapona naglo prekinuta nisu zabilježeni ni NMS niti rabdomioliza povezani s liječenjem entakaponom.
Excipient with known effect: Each tablet contains 1.89 mg of sucrose.
Pomoćna tvar s poznatim učinkom: Jedna tableta sadrži 1,89 mg saharoze.
If other levodopa products are used concomitantly with a Levodopa/Carbidopa/Entacapone Orion tablet, the maximum dose recommendations should be followed.
Orion tabletom koriste drugi preparati levodope, moraju se pratiti preporuke o maksimalnoj dozi.
Patients should be instructed to take only one Levodopa/Carbidopa/Entacapone Orion tablet per dose administration.
Bolesnike se mora upozoriti da prilikom svake primjene lijeka uzmu samo jednu tabletu Levodopa/Carbidopa/Entacapone Oriona.
Each film-coated tablet contains 75 mg of levodopa, 18.75 mg of carbidopa and 200 mg of entacapone.
Jedna filmom obložena tableta sadržava 75 mg levodope, 18,75 mg karbidope i 200 mg entakapona.
75 mg/18.75 mg/200 mg Light brownish red, oval film-coated tablets marked with ‘LCE 75' on one side.
75 mg/18,75 mg/200 mg Svijetlo smećkasto-crvene, ovalne filmom obložene tablete, s oznakom "LCE 75" na jednoj strani.
Blurred vision
Zamagljen vid
Film-coating of 75/18.75/200 mg, 125/31.25/200 mg, 175/43.75/200 mg and 200/50/200 mg: Glycerol (85 per cent) (E422)
Film ovojnica za 75/18,75/200 mg, 125/31,25/200 mg, 175/43,75/200 mg i 200/50/200 mg: glicerol (85-postotni) (E422) hipromeloza magnezijev stearat polisorbat 80 željezov oksid, crveni (E172) saharoza titanijev dioksid (E171)
75 mg/18.75 mg/200 mg Each tablet contains 75 mg of levodopa, 18.75 mg of carbidopa and 200 mg of entacapone.
75 mg/18,75 mg/200 mg Jedna tableta sadrži 75 mg levodope, 18,75 mg karbidope i 200 mg entakapona.
If you forget to take Levodopa/Carbidopa/Entacapone Orion
Ako ste zaboravili uzeti Levodopa/Carbidopa/Entacapone Orion
Hepatic function test abnormal*
Manje često: Poremećeni nalazi testova jetrene funkcije* Nepoznato:
If you during the treatment with Levodopa/Carbidopa/Entacapone Orion 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.
Orionom 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.
levodopa/carbidopa/entacapone orion 75/18.75/200 mg [carton only]
levodopa/carbidopa/entacapone orion 75/18,75/200 mg [samo kutija]
175 mg/43.75 mg/200 mg Each tablet contains 175 mg of levodopa, 43.75 mg of carbidopa and 200 mg of entacapone.
175 mg/43,75 mg/200 mg Jedna tableta sadrži 175 mg levodope, 43,75 mg karbidope i 200 mg entakapona.
125 mg/31.25 mg/200 mg Each tablet contains 125 mg of levodopa, 31.25 mg of carbidopa and 200 mg of entacapone.
125 mg/31,25 mg/200 mg Jedna tableta sadrži 125 mg levodope, 31,25 mg karbidope i 200 mg entakapona.
Each film-coated tablet contains 175 mg of levodopa, 43.75 mg of carbidopa and 200 mg of entacapone.
Jedna filmom obložena tableta sadržava 175 mg levodope, 43,75 mg karbidope i 200 mg entakapona.
Levodopa/Carbidopa/Entacapone Orion comes in six different pack sizes (10, 30, 100, 130, 175 or 250 tablets).
Orion dolazi u šest različitih veličina pakiranja (10, 30, 100, 130, 175 ili 250 tableta).
175 mg/43.75 mg/200 mg Light brownish red, oval, unscored film-coated tablets marked with ‘LCE 175' on one side.
Orion 175 mg/43,75 mg/200 mg: svijetlo smećkasto-crvene, ovalne filmom obložene tablete, bez ureza, s oznakom "LCE 175" na jednoj strani.
Thus, a control of INR is recommended when Levodopa/Carbidopa/Entacapone Orion is initiated for patients receiving warfarin.
Zbog toga se preporučuje kontroliranje INR-a kada se Levodopa/Carbidopa/Entacapone
150 mg/37.5 mg/200 mg Each tablet contains 150 mg of levodopa, 37.5 mg of carbidopa and 200 mg of entacapone.
150 mg/37,5 mg/200 mg Jedna tableta sadrži 150 mg levodope, 37,5 mg karbidope i 200 mg entakapona.
mg/200 mg is 8 tablets per day and Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg dose is 7 tablets per day.
Oriona 175 mg/43,75 mg/200 mg je 8 tableta na dan, a Levodopa/Carbidopa/Entacapone Oriona 200 mg/50 mg/200 mg je 7 tableta na dan.
Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Orion 75 mg/18,75 mg/200 mg tablete dolazi u pet različitih veličina pakiranja (10, 30, 100, 130, ili 175 tableta).
levodopa/carbidopa/entacapone orion 175/43.75/200 mg [carton only]
levodopa/carbidopa/entacapone orion 175/43,75/200 mg [samo kutija]
levodopa/carbidopa/entacapone orion 125/31.25/200 mg [carton only]
levodopa/carbidopa/entacapone orion 125/31,25/200 mg [samo kutija]
100 mg/25 mg/200 mg Each tablet contains 100 mg of levodopa, 25 mg of carbidopa and 200 mg of entacapone.
100 mg/25 mg/200 mg Jedna tableta sadrži 100 mg levodope, 25 mg karbidope i 200 mg entakapona.
200 mg/50 mg/200 mg Each tablet contains 200 mg of levodopa, 50 mg of carbidopa and 200 mg of entacapone.
200 mg/50 mg/200 mg Jedna tableta sadrži 200 mg levodope, 50 mg karbidope i 200 mg entakapona.
50 mg/12.5 mg/200 mg Each tablet contains 50 mg of levodopa, 12.5 mg of carbidopa and 200 mg of entacapone.
50 mg/12,5 mg/200 mg Jedna tableta sadrži 50 mg levodope, 12,5 mg karbidope i 200 mg entakapona.
Each film-coated tablet contains 125 mg of levodopa, 31.25 mg of carbidopa and 200 mg of entacapone.
Jedna filmom obložena tableta sadržava 125 mg levodope, 31,25 mg karbidope i 200 mg entakapona.
Dyspnoea
Dispneja
200 mg/50 mg/200 mg Dark brownish red, oval, unscored film-coated tablets marked with ‘LCE 200' on one side.
Orion 200 mg/50 mg/200 mg: tamno smećkasto-crvene, ovalne filmom obložene tablete, bez ureza, s oznakom "LCE 200" na jednoj strani.
Excipient with known effect: Each tablet contains 2.3 mg of sucrose.
Pomoćna tvar s poznatim učinkom: Jedna tableta sadrži 2,3 mg saharoze.
levodopa/carbidopa/entacapone orion 150/37.5/200 mg [carton only]
levodopa/carbidopa/entacapone orion 150/37,5/200 mg [samo kutija]
B. PACKAGE LEAFLET
Tablica 1. Nuspojave
Levodopa/Carbidopa/Entacapone Orion 150 mg/37.5 mg/200 mg: brownish or greyish red, elongatedellipse shaped, unscored film-coated tablets marked with ‘LCE 150' on one side.
Orion 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.
Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Orion 125 mg/31,25 mg/200 mg tablete dolazi u pet različitih veličina pakiranja (10, 30, 100, 130, ili 175 tableta).
Excipient with known effect: Each tablet contains 1.9 mg of sucrose.
Pomoćna tvar s poznatim učinkom: Jedna tableta sadrži 1,9 mg saharoze.
levodopa/carbidopa/entacapone orion 50/12.5/200 mg [carton only]
levodopa/carbidopa/entacapone orion 50/12,5/200 mg [samo kutija]
Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg: light brownish red, oval filmcoated tablets marked with ‘LCE 125' on one side.
Orion 125 mg/31,25 mg/200 mg: svijetlo smećkasto-crvene, ovalne filmom obložene tablete, s oznakom "LCE 125" na jednoj strani.
Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Orion 200 mg/50 mg/200 mg tablete dolazi u pet različitih veličina pakiranja (10, 30, 100, 130, ili 175 tableta).
levodopa/carbidopa/entacapone orion 100/25/200 mg [carton only]
levodopa/carbidopa/entacapone orion 100/25/200 mg [samo kutija]
100 mg/25 mg/200 mg Brownish or greyish red, oval, unscored film-coated tablets marked with ‘LCE 100' on one side.
Orion 100 mg/25 mg/200 mg: smećkasto ili sivkasto-crvene, ovalne filmom obložene tablete, bez ureza, s oznakom "LCE 100" na jednoj strani.