natgillin/translations-raw huggingface dataset:
- If you are taking Stalevo 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg,
- Ako uzimate Stalevo 50 mg/12,5 mg/200 mg, 75 mg/18,75 mg/200 mg, 100 mg/25 mg/200 mg,
However, a longer dosing interval of Stalevo may be considered for patients who are receiving dialysis therapy (see section 4.2).
Međutim, treba razmotriti dulji interval doziranja Staleva u bolesnika koji su na dijalizi (vidjeti dio
Hepatic impairment: It is advised that Stalevo should be administered cautiously to patients with mild to moderate hepatic impairment.
Oštećenje jetre: savjetuje se oprezna primjena Staleva kod bolesnika s blagim do umjerenim oštećenjem jetre.
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.
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.
Rare:
Često:
Ten tablets of Stalevo 150 mg/37.5 mg/200 mg equals 375 mg of carbidopa a day.
Deset tableta Staleva 150 mg/37,5 mg/200 mg odgovara 375 mg karbidope dnevno.
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
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
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
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,
- The active substances of Stalevo are levodopa, carbidopa and entacapone.
Staleva su levodopa, karbidopa i entakapon.
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.
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.
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.
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.
- 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 ovisničkim obrascem ponašanja koji dovodi do prekomjerne primjene lijeka, a primijećen je u nekih bolesnika liječenih karbidopom/levodopom.
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.
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.
Stalevo contains sucrose
Stalevo sadrži saharozu
stalevo 75/18.75/200 mg [carton only]
stalevo 75/18,75/200 mg [samo kutija]
stalevo 125/31.25/200 mg [carton only]
stalevo 125/31,25/200 mg [samo kutija]
Tel: +386 (0) 1 600 8015
Orion Pharma d.o.o. Tel: +386 (0) 1 600 8015
stalevo 175/43.75/200 mg [carton only]
stalevo 175/43,75/200 mg [samo kutija]
stalevo 100/25/200 mg [carton only]
stalevo 100/25/200 mg [samo kutija]
stalevo 150/37.5/200 mg [carton only]
stalevo 150/37,5/200 mg [samo kutija]
stalevo 50/12.5/200 mg [carton only]
stalevo 50/12,5/200 mg [samo kutija]
stalevo 200/50/200 mg [carton only]
stalevo 200/50/200 mg [samo kutija]
- Periodic evaluation of hepatic, haematopoietic, cardiovascular and renal function is recommended during extended therapy with Stalevo.
- Tijekom produžene terapije Stalevom preporučuje se povremeno pratiti jetrene, hematopoetske, kardiovaskularne i bubrežne funkcije.
Stalevo contains sucrose (2.3 mg/tablet).
Stalevo sadrži saharozu (2,3 mg/tableti).
Stalevo contains sucrose (1.89 mg/tablet).
Stalevo sadrži saharozu (1,89 mg/tableti).
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.
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.
Stalevo 75 mg/18.75 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Stalevo 75 mg/18,75 mg/200 mg tablete dolazi u pet različitih veličina pakiranja (10, 30, 100, 130, ili 175 tableta).
Stalevo 125 mg/31.25 mg/200 mg: light brownish red, oval film-coated tablets marked with ‘LCE 125' on one side.
Stalevo 125 mg/31,25 mg/200 mg: svijetlo smećkasto-crvene, ovalne filmom obložene tablete, s oznakom "LCE 125" na jednoj strani.
Stalevo 175 mg/43.75 mg/200 mg: light brownish red, oval, unscored film-coated tablets marked with ‘LCE 175' on one side.
Stalevo 175 mg/43,75 mg/200 mg: svijetlo smećkasto-crvene, ovalne filmom obložene tablete, bez ureza, s oznakom "LCE 175" na jednoj strani.
Stalevo 75 mg/18.75 mg/200 mg: light brownish red, oval film-coated tablets marked with ‘LCE 75' on one side.
Stalevo 75 mg/18,75 mg/200 mg: svijetlo smećkasto-crvene, ovalne filmom obložene tablete, s oznakom "LCE 75" na jednoj strani.
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.
U kliničkim ispitivanjima sa Stalevom ili entakaponom u kombinaciji s levodopom/DDCinhibitorom otkriveni su ozbiljni događaji gastrointestinalnog krvarenja (manje često) i angioedema (rijetko).
Stalevo 125 mg/31.25 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Stalevo 125 mg/31,25 mg/200 mg tablete dolazi u pet različitih veličina pakiranja (10, 30, 100, 130, ili 175 tableta).
Stalevo 75 mg/18.75 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Stalevo 75 mg/18,75 mg/200 mg filmom obložene tablete levodopa/karbidopa/entakapon
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.
Kako na Stalevo prebaciti bolesnike koji primaju preparate levodope/DDC-inhibitora (karbidopa ili benzerazid) i entakapon tablete a.
- 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.
- Jedna Stalevo 125 mg/31,25 mg/200 mg tableta sadrži 125 mg levodope, 31,25 mg karbidope i 200 mg entakapona.
Stalevo 200 mg/50 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175).
Stalevo 200 mg/50 mg/200 mg tablete dolazi u pet različitih veličina pakiranja (10, 30, 100, 130, ili 175 tableta).
Stalevo 175 mg/43.75 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Stalevo 175 mg/43,75 mg/200 mg tablete dolazi u pet različitih veličina pakiranja (10, 30, 100, 130, ili 175 tableta).
Stalevo contains sucrose (1.9 mg/tablet).
Stalevo sadrži saharozu (1,9 mg/tableti).
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.
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.
Stalevo 200 mg/50 mg/200 mg: dark brownish red, oval, unscored film-coated tablets marked with ‘LCE 200' on one side.
Stalevo 200 mg/50 mg/200 mg: tamno smećkasto-crvene, ovalne filmom obložene tablete, bez ureza, s oznakom "LCE 200" na jednoj strani.
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.
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.
Stalevo 100 mg/25 mg/200 mg: brownish or greyish red, oval, unscored film-coated tablets marked with ‘LCE 100' on one side.
Stalevo 100 mg/25 mg/200 mg: smećkasto ili sivkasto-crvene, ovalne filmom obložene tablete, bez ureza, s oznakom "LCE 100" na jednoj strani.
- 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.
- Jedna Stalevo 175 mg/43,75 mg/200 mg tableta sadrži 175 mg levodope, 43,75 mg karbidope i 200 mg entakapona.
- 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.
- Jedna Stalevo 75 mg/18,75 mg/200 mg tableta sadrži 75 mg levodope, 18,75 mg karbidope i 200 mg entakapona.
- Each Stalevo 100 mg/25 mg/200 mg tablet contains 100 mg of levodopa, 25 mg of carbidopa and 200 mg of entacapone.
- Jedna Stalevo 100 mg/25 mg/200 mg tableta sadrži 100 mg levodope, 25 mg karbidope i 200 mg entakapona.
Stalevo contains sucrose (1.6 mg/tablet).
Stalevo sadrži saharozu (1,6 mg/tableti).
- 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.
- Jedna Stalevo 150 mg/37,5 mg/200 mg tableta sadrži 150 mg levodope, 37,5 mg karbidope i 200 mg entakapona.
Stalevo contains sucrose (1.2 mg/tablet).
Stalevo sadrži saharozu (1,2 mg/tableti).
- 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.
- Jedna Stalevo 50 mg/12,5 mg/200 mg tableta sadrži 50 mg levodope, 12,5 mg karbidope i 200 mg entakapona.
Stalevo 175 mg/43.75 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Stalevo 175 mg/43,75 mg/200 mg filmom obložene tablete levodopa/karbidopa/entakapon
Some patients experience severe abnormal involuntary movements (dyskinesias), mood swings or other side effects after taking large doses of Stalevo.
U nekih se bolesnika nakon uzimanja velikih doza lijeka Stalevo javljaju vrlo izražene neuobičajene nevoljne kretnje (diskinezije), promjene raspoloženja ili druge nuspojave.
Stalevo contains sucrose (1.4 mg/tablet).
Stalevo sadrži saharozu (1,4 mg/tableti).
Stalevo 50 mg/12.5 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Stalevo 50 mg/12,5 mg/200 mg filmom obložene tablete levodopa/karbidopa/entakapon
Tel: + 39 02 67876111
Orion Pharma S.r.l. Tel: + 39 02 67876111
Stalevo 100 mg/25 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Stalevo 100 mg/25 mg/200 mg filmom obložene tablete levodopa/karbidopa/entakapon
Stalevo 150 mg/37.5 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Stalevo 150 mg/37,5 mg/200 mg filmom obložene tablete levodopa/karbidopa/entakapon
- Each Stalevo 200 mg/50 mg/200 mg tablet contains 200 mg of levodopa, 50 mg of carbidopa and 200 mg of entacapone.
- Jedna Stalevo 200 mg/50 mg/200 mg tableta sadrži 200 mg levodope, 50 mg karbidope i 200 mg entakapona.
Stalevo 125 mg/31.25 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Stalevo 125 mg/31,25 mg/200 mg filmom obložene tablete levodopa/karbidopa/entakapon
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
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
Stalevo 200 mg/50 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Stalevo 200 mg/50 mg/200 mg filmom obložene tablete levodopa/karbidopa/entakapon
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.
Kod prelaska liječenja na Stalevo u bolesnika koji se trenutno ne liječe entakaponom, može biti potrebno prilagoditi doze drugih antiparkinsonika.
- 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, željezov oksid crveni (E172), saharoza, titanijev dioksid (E171).
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
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
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
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
Tel: + 34 91 599 86 01
Orion Pharma S.L. Tel: + 34 91 599 86 01
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
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
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
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
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 željezov oksid, crveni (E172) saharoza titanijev dioksid (E171) željezov oksid, žuti (E172)
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
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
- 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) (E 422), hipromeloza, magnezijev stearat, polisorbat 80, crveni željezov oksid (E 172), saharoza, titanijev dioksid (E 171) i žuti željezov oksid(E 172).
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
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
Orion Pharma S.L.
UAB Orion Pharma Tel.
United Kingdom Orion Pharma (UK) Ltd. Tel: +44 1635 520 300
Lifepharma (ZAM) Ltd Τηλ.: +357 22056300
Two of these studies included children.
Dva ta ispitivanja uključivala su djecu.
This summary was last updated in 11-2013.
Sažetak je posljednji put ažuriran 11.2013.
Opatanol can be used for up to four months, if needed.
Opatanol se može koristiti do četiri mjeseca ako je potrebno.
Opatanol is used in adults and children aged three years and older.
Opatanol se koristi u odraslih osoba i djece u dobi od tri godine i starije.
Opatanol has been studied in 688 patients in four main studies lasting between six and 14 weeks.
Opatanol se ispitivao u 688 bolesnika u četiri glavna ispitivanja koja su trajala između šest i 14 tjedana.
The full EPAR for Opatanol 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 Opatanol nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Opatanol olopatadine
Opatanol olopatadin
The medicine can only be obtained with a prescription.
Ovaj se lijek izdaje samo na recept.
Therefore care should be taken by people who wear soft contact lenses.
Stoga osobe koje nose kontaktne leće moraju obratiti pozornost.
The European Commission granted a marketing authorisation valid throughout the European Union for Opatanol on 17 May 2002.
Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Opatanol vrijedi na prostoru Europske unije od 17. svibnja 2002.
When the receptors are blocked, histamine cannot have its effect, and this leads to a decrease in the symptoms of allergy.
Kada su receptori blokirani, histamin ne može djelovati, a to rezultira smanjenjem simptoma alergije.
Other information about Opatanol
Ostale informacije o lijeku Opatanol
At lower pollen counts, there were no differences between the two treatments.
Pri manjoj količini cvjetne peludi, nije bilo razlike između ta dva liječenja.
The most common side effects with Opatanol (seen in between 1 and 10 patients in 100) are headache, dysgeusia (taste disturbances), eye pain, eye irritation, dry eyes, abnormal sensations in the eye, dry nose and fatigue (tiredness).
Najčešće nuspojave lijeka Opatanol (primijećene kod 1 do 10 na 100 osoba) su glavobolja, dizgeuzija (poremećaj osjeta okusa), bol u oku, nadraženost oka, suhe oči, abnormalni osjeti u oku, suhi nos i iscrpljenost (umor).
If another eye treatment is also being used, there should be a gap of five minutes between treatments; eye ointments should be administered last.
Ako se koristi druga terapija za oči, potreban je razmak od pet minuta između dvije terapije; posljednje se trebaju primjenjivati masti za oči.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Opatanol.
Objašnjava kako je Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) ocijenilo lijek da bi donijelo svoje mišljenje u korist davanja odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima za primjenu lijeka Opatanol.
This is a summary of the European public assessment report (EPAR) for Opatanol.
Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za Opatanol.
For more information about treatment with Opatanol, read the package leaflet (also part of the EPAR) or contact your doctor of pharmacist.
Više informacija o terapiji lijekom Opatanol pročitajte u uputama o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
Opatanol was as effective as cromolyn sodium and as levocabastine.
Opatanol je bio jednako djelotvoran kao kromolin-natrij i kao levokabastin.
Opatanol was compared with cromolyn sodium (another anti-allergy medicine), with levocabastine (another antihistamine) and, in two studies, with placebo (a dummy treatment).
Opatanol je uspoređen s kromolin-natrijem (drugim antialergijskim lijekom), s levokabastinom (drugim antihistaminikom) te, u dva ispitivanja, s placebom (lažnim liječenjem).
What is the risk associated with Opatanol?
Koji su rizici povezani s lijekom Opatanol?
When compared with placebo, Opatanol was more effective only when pollen counts were taken into account, showing that the higher the level of pollen in the air, the greater the difference between the effects of Opatanol and those of placebo.
Kada je uspoređen s placebom, Opatanol je bio djelotvorniji samo ako je količina cvjetne peludi uzeta u obzir, što dokazuje da što je količina cvjetne peludi u zraku veća, to je veća razlika između djelovanja lijeka Opatanol i placeba.
The active substance in Opatanol, olopatadine, is an antihistamine.
Djelatna tvar u lijeku Opatanol, olopatadin, je antihistaminik.
These include itching, redness and swelling.
Ti simptomi uključuju svrbež, crvenilo i oticanje.
Why has Opatanol been approved?
Zašto je Opatanol odobren?
Opatanol contains benzalkonium chloride, which is known to discolour soft contact lenses.
Opatanol sadrži benzalkonijev klorid, za koji je poznato da mijenja boju mekih kontaktnih leća.
Olopatadine works by blocking the receptors on which histamine, a substance in the body that causes allergic symptoms, normally attaches itself.
Olopatadin djeluje blokirajući receptore na koje se normalno veže histamin, tvar u tijelu koja uzrokuje alergijske simptome.
The CHMP decided that Opatanol's benefits are greater than its risks for the treatment of ocular signs and symptoms of seasonal allergic conjunctivitis and recommended that it be given marketing authorisation.
CHMP je odlučio da koristi od lijeka Opatanol nadmašuju s njim povezane rizike za liječenje okularnih znakova i simptoma sezonskog alergijskog konjunktivitisa te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
Opatanol is used to treat the eye symptoms of seasonal allergic conjunctivitis (inflammation of the eyes caused by pollen in patients with hayfever).
Opatanol se koristi za liječenje okularnih simptoma sezonskog alergijskog konjunktivitisa (upale očiju uzrokovane cvjetnom peludi u bolesnika s peludnom groznicom).