natgillin/translations-raw huggingface dataset:
If you during the treatment with Corbilta 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.
Ako tijekom liječenja Corbiltom 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.
Usually Corbilta is to be used in patients who are currently treated with corresponding doses of standard release levodopa/DDC inhibitor and entacapone.
Corbiltu obično treba koristiti u bolesnika koji se već liječe odgovarajućim dozama levodope/DDCinhibitora sa standardnim oslobađanjem i entakapona.
No particular studies on the pharmacokinetics of carbidopa and levodopa in patients with hepatic impairment are reported, however, it is advised that Corbilta 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 Corbilte kod bolesnika s blagim ili umjerenim oštećenjem jetre.
Consult your doctor if during the treatment with Corbilta 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.
Savjetujte se sa svojim liječnikom ako tijekom liječenja Corbiltom: - 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.
You should not breast-feed during treatment with Corbilta.
Tijekom liječenja Corbiltom ne smijete dojiti.
Breast-feeding Levodopa is excreted in human breast milk.
Levodopa se izlučuje u majčino mlijeko u ljudi.
- Coadministration of Corbilta with non-selective monoamine oxidase (MAO-A and MAO-B)
- Istodobna primjena Corbilte s neselektivnim inhibitorima monoaminooksidaze (MAO-A i
Talk to your doctor or pharmacist before taking Corbilta 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
Obratite se svom liječniku ili ljekarniku prije nego uzmete Corbilta 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,
When decarboxylation of levodopa is reduced with the co-administration of a DDC inhibitor, a lower dose of levodopa can be used and the incidence of adverse reactionssuch as nausea is reduced.
Kada se istodobnom primjenom DDCinhibitora smanji dekarboksilacija levodope, može se koristiti niža doza levodope, čime se smanjuje učestalost nuspojava kao što je mučnina.
Hepatic impairment: It is advised that Corbilta should be administered cautiously to patients with mild to moderate hepatic impairment.
Oštećenje jetre: savjetuje se oprezna primjena Corbilte kod bolesnika s blagim do umjerenim oštećenjem jetre.
- If you are taking Corbilta 200 mg/50 mg/200 mg, do not take more than 7 tablets of this strength per day.
- Ako uzimate Corbilta 200 mg/50 mg/200 mg tablete, nemojte uzeti više od 7 tableta dnevno.
- If you are taking Corbilta 175 mg/43.75 mg/200 mg tablets, do not take more than 8 tablets of this strength per day.
- Ako uzimate Corbilta 175 mg/43,75 mg/200 mg tablete, nemojte uzeti više od 8 tableta dnevno.
As part of this PSUSA procedure, update of the levodopa/carbidopa/entacapone SmPCs with identical changes regarding dopamine dysregulation syndrome as agreed previously by the CMDh in the PSUSA process for levodopa/carbidopa containing products is considered warranted.
Smatra se opravdanim da se u sklopu ovog PSUSA postupka ažuriraju sažeci opisa svojstava lijeka za levodopu/karbidopu/entakapon s identičnim promjenama vezano uz sindrom poremećene regulacije dopamina, kako je dogovoreno s CMDh-om u prethodnom PSUSA postupku za lijekove koji sadrže levodopu/karbidopu..
However, a longer dosing interval of Corbilta may be considered for patients who are receiving dialysis therapy (see section 4.2).
Međutim, treba razmotriti dulji interval doziranja Corbilte u bolesnika koji su na dijalizi (vidjeti dio
How to store Corbilta
Kako čuvati Corbiltu
- If you are taking Corbilta 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg,
- Ako uzimate Corbilta 50 mg/12,5 mg/200 mg, 75 mg/18,75 mg/200 mg, 100 mg/25 mg/200 mg,
Ten tablets of Corbilta 150 mg/37.5 mg/200 mg equals 375 mg of carbidopa a day.
Deset tableta Corbilte 150 mg/37,5 mg/200 mg odgovara 375 mg karbidope dnevno.
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 Corbilta 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.
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 Corbilte 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.
Do not take Corbilta if you:
Nemojte uzimati Corbiltu
Corbilta 50 mg/12.5 mg/200 mg film-coated tablets Corbilta 75 mg/18.75 mg/200 mg film-coated tablets Corbilta 100 mg/25 mg/200 mg film-coated tablets Corbilta 125 mg/31.25 mg/200 mg film-coated tablets Corbilta 150 mg/37.5 mg/200 mg film-coated tablets Corbilta 175 mg/43.75 mg/200 mg film-coated tablets Corbilta 200 mg/50 mg/200 mg film-coated tablets
Corbilta 50 mg/12,5 mg/200 mg filmom obložene tablete Corbilta 75 mg/18,75 mg/200 mg filmom obložene tablete Corbilta 100 mg/25 mg/200 mg filmom obložene tablete Corbilta 125 mg/31,25 mg/200 mg filmom obložene tablete Corbilta 150 mg/37,5 mg/200 mg filmom obložene tablete Corbilta 175 mg/43,75 mg/200 mg filmom obložene tablete Corbilta 200 mg/50 mg/200 mg filmom obložene tablete
According to this daily carbidopa dose, the maximum recommended daily dose of Corbilta175 mg/43.75 mg/200 mg is 8 tablets per day and Corbilta 200 mg/50 mg/200 mg dose is 7 tablets per day.
najviša preporučena dnevna doza Corbilte 175 mg/43,75 mg/200 mg je 8 tableta na dan, a Corbilte 200 mg/50 mg/200 mg je 7 tableta na dan.
b. When initiating Corbilta therapy for patients currently treated with entacapone and levodopa/carbidopa in doses not equal to Corbilta 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), Corbilta dosing should be carefully titrated for optimal clinical response.
Kada se terapija Corbiltom uvodi bolesnicima koji su trenutno liječeni entakaponom i levodopom/karbidopom u dozama koje ne odgovaraju Corbilta 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 Corbilte mora biti pažljivo titrirano radi optimalnog kliničkog odgovora.
corbilta 75/18.75/200 mg [carton only]
corbilta 75/18,75/200 mg [samo kutija]
corbilta 125/31.25/200 mg [carton only]
corbilta 125/31,25/200 mg [samo kutija]
organizačná zložka Tel: +421 2 48 200 600
Slovenská republika Sandoz d.d. organizačná zložka Tel: +421 2 48 200 600
corbilta 175/43.75/200 mg [carton only]
corbilta 175/43,75/200 mg [samo kutija]
Corbilta contains sucrose
Corbilta sadrži saharozu
corbilta 150/37.5/200 mg [carton only]
corbilta 150/37,5/200 mg [samo kutija]
- Periodic evaluation of hepatic, haematopoietic, cardiovascular and renal function is recommended during extended therapy with Corbilta.
- Tijekom produžene terapije Corbiltom preporučuje se povremeno pratiti jetrene, hematopoetske, kardiovaskularne i bubrežne funkcije.
corbilta 50/12.5/200 mg [carton only]
corbilta 50/12,5/200 mg [samo kutija]
corbilta 100/25/200 mg [carton only]
corbilta 100/25/200 mg [samo kutija]
corbilta 200/50/200 mg [carton only]
corbilta 200/50/200 mg [samo kutija]
Tel: +386 1 580 21 11
Lek Pharmaceuticals d.d. Tel: +386 1 580 21 11
Corbilta 150 mg/37.5 mg/200 mg: brownish or greyish red, elongated-ellipse shaped, unscored filmcoated tablets marked with ‘LCE 150' on one side.
Corbilta 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.
Corbilta 75 mg/18.75 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Corbilta 75 mg/18,75 mg/200 mg tablete dolazi u pet različitih veličina pakiranja (10, 30, 100, 130, ili 175 tableta).
Corbilta 175 mg/43.75 mg/200 mg: light brownish red, oval, unscored film-coated tablets marked with ‘LCE 175' on one side.
Corbilta 175 mg/43,75 mg/200 mg: svijetlo smećkasto-crvene, ovalne filmom obložene tablete, bez ureza, s oznakom "LCE 175" na jednoj strani.
Corbilta contains sucrose (1.89 mg/tablet).
Corbilta sadrži saharozu (1,89 mg/tableti).
Corbilta 125 mg/31.25 mg/200 mg: light brownish red, oval film-coated tablets marked with ‘LCE 125' on one side.
Corbilta 125 mg/31,25 mg/200 mg: svijetlo smećkasto-crvene, ovalne filmom obložene tablete, s oznakom "LCE 125" na jednoj strani.
Corbilta contains sucrose (2.3 mg/tablet).
Corbilta sadrži saharozu (2,3 mg/tableti).
Corbilta 75 mg/18.75 mg/200 mg: light brownish red, oval film-coated tablets marked with ‘LCE 75' on one side.
Corbilta 75 mg/18,75 mg/200 mg: svijetlo smećkasto-crvene, ovalne filmom obložene tablete, s oznakom "LCE 75" na jednoj strani.
Corbilta 125 mg/31.25 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Corbilta 125 mg/31,25 mg/200 mg tablete dolazi u pet različitih veličina pakiranja (10, 30, 100, 130, ili 175 tableta).
Serious events of gastrointestinal haemorrhage (uncommon) and angioedema (rare) have been identified from the clinical trials with Corbilta or entacapone combined with levodopa/DDC inhibitor.
U kliničkim ispitivanjima s Corbiltom ili entakaponom u kombinaciji s levodopom/DDCinhibitorom otkriveni su ozbiljni događaji gastrointestinalnog krvarenja (manje često) i angioedema (rijetko).
Corbilta 200 mg/50 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175).
Corbilta 200 mg/50 mg/200 mg tablete dolazi u pet različitih veličina pakiranja (10, 30, 100, 130, ili 175 tableta).
Corbilta 75 mg/18.75 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Corbilta 75 mg/18,75 mg/200 mg filmom obložene tablete levodopa/karbidopa/entakapon
- Each Corbilta 125 mg/31.25 mg/200 mg tablet contains 125 mg of levodopa, 31.25 mg of carbidopa and 200 mg of entacapone.
- Jedna Corbilta 125 mg/31,25 mg/200 mg tableta sadrži 125 mg levodope, 31,25 mg karbidope i 200 mg entakapona.
- Each Corbilta 75 mg/18.75 mg/200 mg tablet contains 75 mg of levodopa, 18.75 mg of carbidopa and 200 mg of entacapone.
- Jedna Corbilta 75 mg/18,75 mg/200 mg tableta sadrži 75 mg levodope, 18,75 mg karbidope i 200 mg entakapona.
Corbilta 50 mg/12.5 mg/200 mg: brownish or greyish red, round, convex unscored film-coated tablets marked with ‘LCE 50' on one side.
Corbilta 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.
- Each Corbilta 175 mg/43.75 mg/200 mg tablet contains 175 mg of levodopa, 43.75 mg of carbidopa and 200 mg of entacapone.
- Jedna Corbilta 175 mg/43,75 mg/200 mg tableta sadrži 175 mg levodope, 43,75 mg karbidope i 200 mg entakapona.
Corbilta 175 mg/43.75 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Corbilta 175 mg/43,75 mg/200 mg tablete dolazi u pet različitih veličina pakiranja (10, 30, 100, 130, ili 175 tableta).
Initiation of Corbilta 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.
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 Corbilte u dozama odgovarajućim trenutnoj terapiji.
Corbilta 100 mg/25 mg/200 mg: brownish or greyish red, oval, unscored film-coated tablets marked with ‘LCE 100' on one side.
Corbilta 100 mg/25 mg/200 mg: smećkasto ili sivkasto-crvene, ovalne filmom obložene tablete, bez ureza, s oznakom "LCE 100" na jednoj strani.
Corbilta 200 mg/50 mg/200 mg: dark brownish red, oval, unscored film-coated tablets marked with ‘LCE 200' on one side.
Corbilta 200 mg/50 mg/200 mg: tamno smećkasto-crvene, ovalne filmom obložene tablete, bez ureza, s oznakom "LCE 200" na jednoj strani.
- Each Corbilta 100 mg/25 mg/200 mg tablet contains 100 mg of levodopa, 25 mg of carbidopa and 200 mg of entacapone.
- Jedna Corbilta 100 mg/25 mg/200 mg tableta sadrži 100 mg levodope, 25 mg karbidope i 200 mg entakapona.
- Each Corbilta 50 mg/12.5 mg/200 mg tablet contains 50 mg of levodopa, 12.5 mg of carbidopa and 200 mg of entacapone.
- Jedna Corbilta 50 mg/12,5 mg/200 mg tableta sadrži 50 mg levodope, 12,5 mg karbidope i 200 mg entakapona.
- Each Corbilta 150 mg/37.5 mg/200 mg tablet contains 150 mg of levodopa, 37.5 mg of carbidopa and 200 mg of entacapone.
- Jedna Corbilta 150 mg/37,5 mg/200 mg tableta sadrži 150 mg levodope, 37,5 mg karbidope i 200 mg entakapona.
Some patients experience severe abnormal involuntary movements (dyskinesias), mood swings or other side effects after taking large doses of Corbilta.
U nekih se bolesnika nakon uzimanja velikih doza lijeka Corbilta javljaju vrlo izražene neuobičajene nevoljne kretnje (diskinezije), promjene raspoloženja ili druge nuspojave.
Corbilta contains sucrose (1.9 mg/tablet).
Corbilta sadrži saharozu (1,9 mg/tableti).
How to transfer patients taking levodopa/DDC inhibitor (carbidopa or benserazide) preparations and entacapone tablets to Corbilta a. Patients who are currently treated with entacapone and with standard release levodopa/carbidopa in doses equal to Corbilta tablet strengths can be directly transferred to corresponding Corbilta tablets.
Kako na Corbiltu prebaciti bolesnike koji primaju preparate levodope/DDC-inhibitora (karbidopa ili benzerazid) i entakapon tablete a.
Corbilta 175 mg/43.75 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Corbilta 175 mg/43,75 mg/200 mg filmom obložene tablete levodopa/karbidopa/entakapon
Corbilta 125 mg/31.25 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Corbilta 125 mg/31,25 mg/200 mg filmom obložene tablete levodopa/karbidopa/entakapon
Corbilta contains sucrose (1.6 mg/tablet).
Corbilta sadrži saharozu (1,6 mg/tableti).
- Each Corbilta 200 mg/50 mg/200 mg tablet contains 200 mg of levodopa, 50 mg of carbidopa and 200 mg of entacapone.
- Jedna Corbilta 200 mg/50 mg/200 mg tableta sadrži 200 mg levodope, 50 mg karbidope i 200 mg entakapona.
If you get any side effects talk to your doctor or pharmacist.
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti svog liječnika ili ljekarnika.
Corbilta contains sucrose (1.2 mg/tablet).
Corbilta sadrži saharozu (1,2 mg/tableti).
Corbilta contains sucrose (1.4 mg/tablet).
Corbilta sadrži saharozu (1,4 mg/tableti).
Corbilta 100 mg/25 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Corbilta 100 mg/25 mg/200 mg filmom obložene tablete levodopa/karbidopa/entakapon
EU/1/13/859/007 10 film-coated tablets EU/1/13/859/008 30 film-coated tablets EU/1/13/859/009 100 film-coated tablets EU/1/13/859/010 130 film-coated tablets EU/1/13/859/011 175 film-coated tablets
EU/1/13/859/007 10 filmom obloženih tableta EU/1/13/859/008 30 filmom obloženih tableta EU/1/13/859/009 100 filmom obloženih tableta EU/1/13/859/010 130 filmom obloženih tableta EU/1/13/859/011 175 filmom obloženih tableta
Corbilta 150 mg/37.5 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Corbilta 150 mg/37,5 mg/200 mg filmom obložene tablete levodopa/karbidopa/entakapon
The doses of other antiparkinsonian medicinal products may need to be adjusted when Corbilta treatment is substituted for a patient currently not treated with entacapone.
Kod prelaska liječenja na Corbiltu u bolesnika koji se trenutno ne liječe entakaponom, može biti potrebno prilagoditi doze drugih antiparkinsonika.
Corbilta 50 mg/12.5 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Corbilta 50 mg/12,5 mg/200 mg filmom obložene tablete levodopa/karbidopa/entakapon
Corbilta 200 mg/50 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Corbilta 200 mg/50 mg/200 mg filmom obložene tablete levodopa/karbidopa/entakapon
EU/1/13/859/023 10 film-coated tablets EU/1/13/859/024 30 film-coated tablets EU/1/13/859/025 100 film-coated tablets EU/1/13/859/026 130 film-coated tablets EU/1/13/859/027 175 film-coated tablets EU/1/13/859/028 250 film-coated tablets
EU/1/13/859/023 10 filmom obloženih tableta EU/1/13/859/024 30 filmom obloženih tableta EU/1/13/859/025 100 filmom obloženih tableta EU/1/13/859/026 130 filmom obloženih tableta EU/1/13/859/027 175 filmom obloženih tableta EU/1/13/859/028 250 filmom obloženih tableta
- 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).
- Drugi sastojci u ovojnici tablete su glicerol (85-postotni) (E422), hipromeloza, magnezijev stearat, polisorbat 80, crveni željezov oksid (E172), saharoza i titanijev dioksid (E171).
EU/1/13/859/001 10 film-coated tablets EU/1/13/859/002 30 film-coated tablets EU/1/13/859/003 100 film-coated tablets EU/1/13/859/004 130 film-coated tablets EU/1/13/859/005 175 film-coated tablets EU/1/13/859/006 250 film-coated tablets
EU/1/13/859/001 10 filmom obloženih tableta EU/1/13/859/002 30 filmom obloženih tableta EU/1/13/859/003 100 filmom obloženih tableta EU/1/13/859/004 130 filmom obloženih tableta EU/1/13/859/005 175 filmom obloženih tableta EU/1/13/859/006 250 filmom obloženih tableta
EU/1/13/859/018 10 film-coated tablets EU/1/13/859/019 30 film-coated tablets EU/1/13/859/020 100 film-coated tablets EU/1/13/859/021 130 film-coated tablets EU/1/13/859/022 175 film-coated tablets
EU/1/13/859/018 10 filmom obloženih tableta EU/1/13/859/019 30 filmom obloženih tableta EU/1/13/859/020 100 filmom obloženih tableta EU/1/13/859/021 130 filmom obloženih tableta EU/1/13/859/022 175 filmom obloženih tableta
EU/1/13/859/034 10 film-coated tablets EU/1/13/859/035 30 film-coated tablets EU/1/13/859/036 100 film-coated tablets EU/1/13/859/037 130 film-coated tablets EU/1/13/859/038 175 film-coated tablets
EU/1/13/859/034 10 filmom obloženih tableta EU/1/13/859/035 30 filmom obloženih tableta EU/1/13/859/036 100 filmom obloženih tableta EU/1/13/859/037 130 filmom obloženih tableta EU/1/13/859/038 175 filmom obloženih tableta
- 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).
- Drugi sastojci u ovojnici tablete su glicerol (85-postotni) (E422), hipromeloza, magnezijev stearat, polisorbat 80, crveni željezov oksid, (E172), saharoza, titanijev dioksid (E171) i žuti željezov oksid (E172).
EU/1/13/859/029 10 film-coated tablets EU/1/13/859/030 30 film-coated tablets EU/1/13/859/031 100 film-coated tablets EU/1/13/859/032 130 film-coated tablets EU/1/13/859/033 175 film-coated tablets
EU/1/13/859/029 10 filmom obloženih tableta EU/1/13/859/030 30 filmom obloženih tableta EU/1/13/859/031 100 filmom obloženih tableta EU/1/13/859/032 130 filmom obloženih tableta EU/1/13/859/033 175 filmom obloženih tableta
EU/1/13/859/012 10 film-coated tablets EU/1/13/859/013 30 film-coated tablets EU/1/13/859/014 100 film-coated tablets EU/1/13/859/015 130 film-coated tablets EU/1/13/859/016 175 film-coated tablets EU/1/13/859/017 250 film-coated tablets
EU/1/13/859/012 10 filmom obloženih tableta EU/1/13/859/013 30 filmom obloženih tableta EU/1/13/859/014 100 filmom obloženih tableta EU/1/13/859/015 130 filmom obloženih tableta EU/1/13/859/016 175 filmom obloženih tableta EU/1/13/859/017 250 filmom obloženih tableta
- The active substances of Corbilta are levodopa, carbidopa and entacapone.
Corbilte su levodopa, karbidopa i entakapon.
Protelos is taken as one sachet once a day.
Protelos se uzima kao jedna vrećica jedanput na dan.
The full EPAR for Protelos can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Protelos nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The European Commission granted a marketing authorisation valid throughout the European Union for Protelos on 21 September 2004.
Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Protelos vrijedi na prostoru Europske unije od 21. rujna 2004.
What measures are being taken to ensure the safe and effective use of Protelos?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Protelos?
Protelos should be taken at least two hours after food, milk, milk products or calcium supplements, preferably at bedtime.
Protelos treba uzeti barem 2 sata nakon hrane, mlijeka, mliječnih proizvoda ili nadopune kalcija, po mogućnosti u vrijeme odlaska na spavanje.
Other information about Protelos
Ostale informacije o lijeku Protelos
The company will also conduct a study to evaluate the effectiveness of the measures that have been put in place to reduce risk of heart and circulatory problems.
Tvrtka će također provesti ispitivanje za procjenu učinkovitosti uspostavljenih mjera za smanjivanje rizika od srčanih i krvožilnih problema.
Protelos is intended for long-term use.
Protelos je namijenjen dugotrajnoj primjeni.
However, when looking only at women of 74 years of age or older with particularly weak thighbones, the results suggested a reduction of the risk of breaks in the hip with Protelos.
Međutim, ako se uzmu u obzir samo žene starije od 74 godine s posebno slabom bedrenom kosti, rezultati pokazuju smanjenje rizika od prijeloma kuka s lijekom Protelos.
In order to reduce the risk of heart attack, Protelos must also not be used in patients with high blood pressure that is not properly controlled or in patients with a current or past history of any of the following:
Kako bi se smanjio rizik od srčanog udara, lijek Protelos također se ne smije koristiti kod bolesnika s visokim krvnim tlakom koji se ne kontrolira ispravno ili kod bolesnika s trenutačnom ili prethodnom povijesti bolesti koja uključuje:
What is Protelos?
Što je Protelos?
This showed that the risk of breaking a bone is reduced.
To ukazuje na smanjenje rizika od prijeloma kosti.
As there has been some data showing an increased risk of heart attack with Protelos, the decision to prescribe Protelos should take into account the patient's individual heart risk.
Budući da postoje podaci koji dokazuju povećani rizik od srčanog udara pri uporabi lijeka Protelos, pri donošenju odluke o propisivanju lijeka Protelos treba uzeti u obzir pojedinačni srčani rizik bolesnika.
This is a summary of the European public assessment report (EPAR) for Protelos.
Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Protelos.
What is the risk associated with Protelos?
Koji su rizici povezani s lijekom Protelos?