FrancophonIA/ELRC3.0 huggingface dataset:
English: * darunavir/ritonavir + 50 mg simeprevir compared to 150 mg simeprevir alone.
Slovak: + simeprevir 50 mg v porovnaní so samotným simeprevirom 150 mg.
English: 3 To prior treatment with peginterferon alfa and ribavirin.
Slovak: Na predchádzajúcu liečbu peginterferónom alfa a ribavirínom.
English: The adverse reactions are listed by system organ class (SOC) and frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000).
Slovak: 1/100 až < 1/10), menej časté (≥
English: Table 14: Treatment outcome in HCV genotype 1 infected patients without cirrhosis receiving 12 weeks simeprevir + sofosbuvir, with or without ribavirin (study HPC2002) Treatment outcome simeprevir + sofosbuvir N = 21 % (n/N)
Slovak: Tabuľka 14: Výsledok liečby u pacientov infikovaných HCV genotypu 1 bez cirhózy, ktorí dostávali 12 týždňov simeprevir + sofosbuvir, s ribavirínom alebo bez ribavirínu (štúdia HPC2002)
English: GLUCOCORTICOIDS Dexamethasone (systemic)
Slovak: Dexametazón (podávaný systémovo)
English: 40 mg omeprazole AUC 1.21 (1.00-1.46) ↑ omeprazole Cmax 1.14 (0.93-1.39) ↑ omeprazole Cmin not studied
Slovak: ↑ omeprazol Cmax 1,14 (0,93-1,39)
English: If a dose of OLYSIO is missed, and the patient notices within 12 hours of the usual dosing time, the patient should take the missed dose of OLYSIO with food as soon as possible and then take the next dose of OLYSIO at the regularly scheduled time.
Slovak: pacient má užiť vynechanú dávku lieku OLYSIO čím skôr spolu s jedlom, a potom pokračovať v užívaní ďalšej dávky lieku OLYSIO vo zvyčajnom čase.
English: Patients with mild to moderate rashes should be monitored for possible progression of rash, including the development of mucosal signs or systemic symptoms.
Slovak: U pacientov s miernymi až stredne závažnými vyrážkami sa má sledovať možná progresia vyrážky,
English: Seventy-seven percent (200/259) of simeprevir-treated patients had undetectable HCV RNA at week 4; in these patients the SVR12 rate was 87%.
Slovak: %. 77 % (200/259) pacientov liečených simeprevirom malo nedetekovateľnú HCV RNA v 4. týždni; u týchto pacientov bol podiel
English: 1 Includes relapsers, partial and null reponders to prior treatment with interferon (pegylated or non-pegylated), with or without ribavirin, and interferon-intolerant patients.
Slovak: (pegylovaným alebo nepegylovaným), s ribavirínom alebo bez ribavirínu, a pacientov s intoleranciou na interferón.
English: Table 18: Studies conducted with simeprevir + peginterferon alfa + ribavirin: demographics and baseline characteristics Pooled C208 and C216 N = 785
Slovak: Tabuľka 18: Štúdie vykonané so simeprevirom + peginterferónom alfa + ribavirín: demografické údaje a východiskové charakteristiky
English: Simeprevir in combination with sofosbuvir: ‘Blood bilirubin increased' was reported in 1.0% of patients receiving 12 weeks of treatment compared to 3.2% in patients receiving 24 weeks of treatment (all grades).
Slovak: Simeprevir v kombinácii so sofosbuvirom: „Zvýšená hladina bilirubínu v krvi“ bola hlásená u 1,0 %
English: NAME OF THE MEDICINAL PRODUCT OLYSIO 150 mg capsules simeprevir
Slovak: NÁZOV LIEKU OLYSIO 150 mg kapsuly simeprevir
English: Study HPC3007: includes 5 simeprevir-treated patients who experienced relapse after SVR12.
Slovak: zahŕňa 5 pacientov liečených simeprevirom, u ktorých došlo k recidíve po SVR12.
English: Therefore, co-administration of OLYSIO with substances that moderately or strongly inhibit or induce CYP3A4 is not recommended.
Slovak: ktoré stredne silno alebo silno inhibujú alebo indukujú CYP3A4, neodporúča.
English: (studies HPC3007 and C206) Treatment Outcome
Slovak: C216 a HPC3007 (prvých 12 týždňov liečby).
English: It is not recommended to co-administer OLYSIO with efavirenz as co-administration may result in loss of therapeutic effect of OLYSIO.
Slovak: Súbežné podávanie OLYSIA s efavirenzom sa neodporúča, pretože súbežné podávanie môže viesť k strate terapeutického účinku
English: DXM AUC 1.08 (0.87-1.35) ↑ DXM Cmax 1.21 (0.93-1.57) ↑ DXM Cmin not studied dextrorphan AUC 1.09 (1.03-1.15) ↔ dextrorphan Cmax 1.03 (0.93-1.15) ↔ dextrorphan Cmin not studied
Slovak: DXM Cmin nesledovala sa dextrorfan AUC 1,09 (1,03-1,15)
English: Table 3: Treatment stopping rules in patients receiving OLYSIO in combination with peginterferon alfa and ribavirin with inadequate on-treatment virologic response
Slovak: v kombinácii s peginterferónom alfa a ribavirínom a s nedostatočnou virologickou odpoveďou počas liečby
English: Prior partial responders Prior null responders Outcome for patients without SVR On-treatment failure Prior relapsers
Slovak: pacienti s recidívou v minulosti čiastoční respondenti v minulosti nuloví respondenti v minulosti
English: HCV geno/subtype and presence of baseline Q80K polymorphism in HCV genotype 1a Genotype 1a with Q80K without Q80K Genotype 1b
Slovak: HCV geno/subtyp a prítomnosť východiskového polymorfizmu Q80K u HCV genotypu 1a HCV genotyp 1a s Q80K HCV genotyp 1b
English: What OLYSIO is - OLYSIO contains the active substance ‘simeprevir'.
Slovak: - OLYSIO obsahuje liečivo „simeprevir“.
English: (OATP1B1/3, BCRP transporter inhibition)
Slovak: (inhibícia transportéra OATP1B1/3, BCRP)
English: HCV geno/subtype and presence of baseline Q80K polymorphism in HCV genotype 1a HCV genotype 1a with Q80K
Slovak: HCV geno/subtyp a prítomnosť polymorfizmu Q80K u HCV genotypu 1a
English: Genotype 4, treatment-naïve or treatment-experienced4
Slovak: Genotyp 1, t „naivní“ pacienti alebo pacienti po predchádzajúcej liečbe 4,
English: Decreased plasma concentrations of simeprevir are expected.
Slovak: Očakáva sa zníženie plazmatickej koncentrácie simepreviru.
English: It is not recommended to co-administer OLYSIO with rifampicin as co-administration may result in loss of therapeutic effect of OLYSIO.
Slovak: Súbežné podávanie OLYSIA s rifampicínom sa neodporúča, pretože súbežné podávanie môže viesť k strate terapeutického účinku
English: HMG CO-A REDUCTASE INHIBITORS Rosuvastatin
Slovak: INHIBÍTORY REDUKTÁZY
English: Significantly increased plasma concentrations of simeprevir are expected.
Slovak: Očakáva sa významné zvýšenie plazmatickej koncentrácie simepreviru.
English: 1 Viral relapse rates are calculated with a denominator of patients with undetectable (or unconfirmed detectable) HCV RNA at actual EOT.
Slovak: Podiely virologickej recidívy sú vypočítané s denominátorom pacientov s nedetekovateľnou (alebo nepotvrdenou detekovateľnou)
English: The 40 enrolled patients had a median age of 51 years (range 29 to 69 years; with 5% above 65 years); 73% were male; 18% had a BMI ≥ 30 kg/m2; the median baseline HCV RNA level was 6.35 log10 IU/ml; 18% had cirrhosis; 25% had HCV genotype 4a, and 73% HCV genotype 4d; 85%
Slovak: % malo BMI ≥ 30 kg/m2; medián východiskovej hladiny HCV RNA bol 6,35 log10 IU/ml; 18 % malo cirhózu; 25 % malo HCV genotypu 4a a 73 % HCV genotypu 4d; 85 % malo non-CC
English: Increased plasma concentrations of lovastatin are expected.
Slovak: Očakáva sa zvýšenie plazmatickej koncentrácie lovastatínu.
English: (OATP1B1/3 transporter inhibition)
Slovak: (inhibícia transportéra OATP1B1/3)
English: No dose adjustment of OLYSIO is required in patients with mild or moderate renal impairment.
Slovak: OLYSIO sa neodporúča u pacientov so stredne závažnou alebo závažnou poruchou funkcie pečene
English: - digoxin, disopyramide, flecainide, mexiletine, propafenone or quinidine (when taken by mouth)
Slovak: - digoxín, disopyramid, flekainid, mexiletín, propafenón alebo chinidín (keď sa užíva cez ústa) alebo amiodarón na liečbu nepravidelného tlkotu srdca - klaritromycín, erytromycín (keď sa užíva cez ústa alebo sa podáva injekčne) alebo telitromycín na liečbu bakteriálnych infekcií
English: Magnesium hydroxide Calcium carbonate
Slovak: Hydroxid hlinitý alebo horečnatý Uhličitan vápenatý
English: The 167 enrolled patients had a median age of 57 years (range 27 to 70 years; with 5% above 65 years); 64% were male; 81% were White, 19% Black or African American, and 21% Hispanic; 37% had a BMI ≥ 30 kg/m2; the median baseline HCV RNA level was 6.7 log10 IU/ml;
Slovak: 167 zaregistrovaných pacientov malo medián veku 57 rokov (v rozmedzí od 27 do 70 rokov, s 5 % nad 65 rokov); 64 % boli muži; 81 % boli belosi,
English: HPC3007 N = 393
Slovak: HPC3007.
English: NAME OF THE MEDICINAL PRODUCT OLYSIO 150 mg hard capsules simeprevir
Slovak: NÁZOV LIEKU OLYSIO 150 mg tvrdé kapsuly simeprevir
English: 0.035 mg once daily/ 1 mg once daily ethinylestradiol AUC 1.12 (1.05-1.20) ↔ ethinylestradiol Cmax 1.18 (1.09-1.27) ↑ ethinylestradiol Cmin 1.00 (0.89-1.13) ↔ norethindrone AUC 1.15 (1.08-1.22) ↔ norethindrone Cmax 1.06 (0.99-1.14) ↔ norethindrone Cmin 1.24 (1.13-1.35) ↑
Slovak: 0,035 mg jedenkrát denne/1 mg jedenkrát denne etinylestradiol AUC 1,12 (1,05-1,20)
English: Increased plasma concentrations of simeprevir are expected.
Slovak: Očakáva sa zvýšenie plazmatickej koncentrácie simepreviru.
English: Simvastatin 40 mg simvastatin AUC 1.51 (1.32-1.73) ↑ simvastatin Cmax 1.46 (1.17-1.82) ↑ simvastatin Cmin not studied simvastatin acid AUC 1.88 (1.63-2.17) ↑ simvastatin acid Cmax 3.03 (2.49-3.69) ↑ simvastatin acid Cmin not studied
Slovak: Cmin nesledoval sa kyselina simvastatínová AUC 1,88 (1,63-2,17)↑ kyselina simvastatínová
English: Pitavastatin Pravastatin
Slovak: Pitavastatín Pravastatín
English: N = 10 % (n/N)
Slovak: 40 % (n/N)
English: Rilpivirine 25 mg once daily rilpivirine AUC 1.12 (1.05-1.19) ↔ rilpivirine Cmax 1.04 (0.95-1.13) ↔ rilpivirine Cmin 1.25 (1.16-1.35) ↑ simeprevir AUC 1.06 (0.94-1.19) ↔ simeprevir Cmax 1.10 (0.97-1.26) ↑ simeprevir Cmin 0.96 (0.83-1.11) ↔
Slovak: Rilpivirín 25 mg jedenkrát denne rilpivirín AUC 1,12 (1,05-1,19)
English: OLYSIO is not recommended in patients with moderate or severe hepatic impairment (Child-Pugh class B or C) (see sections 4.2, 4.8 and 5.2).
Slovak: B alebo C) (pozri časti 4.2, 4.8 a 5.2).
English: STIMULANTS Methylphenidate
Slovak: INHIBÍTORY FOSFODIESTERÁZY
English: The proportion of simeprevir-treated patients with HCV RNA < 25 IU/ml detectable at week 4 was 18% (47/259); 60% achieved SVR12.
Slovak: Podiel pacientov liečených simeprevirom s detekovateľnou HCV RNA < 25 IU/ml v 4. týždni bol 18
English: This is particularly significant if these are accompanied by either of the following symptoms: - feel sick (nauseous), are sick (vomit) or lose your appetite - confusion.
Slovak: Je to obzvlášť dôležité, ak sú sprevádzané niektorými z nasledovných príznakov
English: Treatment with OLYSIO must be initiated in combination with peginterferon alfa + ribavirin and administered for 12 weeks and then followed by an additional 12 weeks of peginterferon alfa + ribavirin.
Slovak: 12 týždňov, potom má nasledovať ďalších 12 týždňov liečby peginterferónom alfa + ribavirínom.
English: Chemistry
Slovak: LIEKY
English: Rash
Slovak: RTIs)
English: 4 Viral relapse rates are calculated with a denominator of patients with undetectable HCV RNA at EOT and with at least one follow-up HCV RNA assessment.
Slovak: HCV RNA na EOT a s najmenej jedným následným hodnotením HCV RNA.
English: OLYSIO is not recommended for patients with moderate or severe hepatic impairment (Child-Pugh class B or C) (see sections 4.4 and 5.2).
Slovak: OLYSIO sa neodporúča pacientom so stredne závažnou alebo závažnou poruchou funkcie pečene (Childova-Pughova trieda
English: Treatment with OLYSIO must be initiated in combination with peginterferon alfa + ribavirin and administered for 12 weeks and then followed by an additional 36 weeks of peginterferon alfa and + ribavirin.
Slovak: 12 týždňov, potom má nasledovať ďalších 36 týždňov liečby peginterferónom alfa + ribavirínom.
English: (strong CYP3A4 enzyme inhibition)
Slovak: (silná inhibícia enzýmu CYP3A4)
English: 1 When considering OLYSIO combination treatment with peginterferon alfa and ribavirin in HCV genotype 1a patients,
Slovak: s peginterferónom alfa a ribavirínom u pacientov s HCV genotypu 1 alebo 4 Populácia pacientov
English: 1 Simeprevir in combination with sofosbuvir: pooled studies HPC2002, HPC3017 and HPC3018 (12 weeks) or study HPC2002 (24 weeks); simeprevir in combination with peginterferon alfa and ribavirin: pooled phase 3 studies C208, C216 and HPC3007 (first 12 weeks of treatments).
Slovak: týždňov) alebo štúdia HPC2002 (24 týždňov); simeprevir v kombinácii s peginterferónom alfa a ribavirínom: zlúčené štúdie fázy 3 C208,
English: Includes
Slovak: ALEBO
English: In 32 out of 48 patients (67%) with emerging single D168V and in 34 out of 66 (52%) patients with emerging single R155K, the respective emerging variants were no longer detected at end of the studies.
Slovak: %) s vyskytujúcou sa jedinou D168V a u 34 zo 66 (52
English: simeprevir % (n/N)
Slovak: % (n/N)
English: Genotype 1, treatment-experienced4
Slovak: Virologická recidíva4
English: Baseline polymorphisms at NS3 positions 43, 80, 122, 155, 156, and/or 168, associated with reduced simeprevir activity in vitro were generally uncommon (1.3%) in patients with HCV genotype 1 infection (n = 2,007; pooled phase 2 and phase 3 studies with simeprevir in combination with peginterferon alfa and ribavirin), with exception of the substitution Q80K in HCV genotype 1a patients which was seen 30% in patients with HCV genotype 1a and 0.5% in patients with HCV genotype 1b.
Slovak: %) u pacientov infikovaných HCV genotypu 1 (n = 2007; v zlúčených štúdiách fazy 2 a 3 so simeprevirom v kombinácii s peginterferónom alfa a ribavirínom), s výnimkou substitúcie Q80K u pacientov s HCV genotypu 1a, ktorá bola pozorovaná u 30 % pacientov s HCV genotypu 1a a 0,5
English: Prior treatment history treatment-naïve treatment-experienced2
Slovak: „naivní“ pacienti po predchádzajúcej liečbe2
English: HCV genotype 1b
Slovak: HCV genotyp 1a s Q80K
English: 400 mg twice a day raltegravir AUC 1.08 (0.85-1.38) ↑ raltegravir Cmax 1.03 (0.78-1.36) ↔ raltegravir Cmin 1.14 (0.97-1.36) ↑ simeprevir AUC 0.89 (0.81-0.98) ↔ simeprevir Cmax 0.93 (0.85-1.02) ↔ simeprevir Cmin 0.86 (0.75-0.98) ↓
Slovak: 400 mg dvakrát denne raltegravir AUC 1,08 (0,85-1,38)
English: WHO toxicity range1
Slovak: Rozsah toxicity podľa
English: Elevations in direct and indirect bilirubin have been reported in patients treated with simeprevir and were mostly of mild or moderate severity.
Slovak: U pacientov liečených simeprevirom bolo hlásené zvýšenie hladiny priameho a nepriameho bilirubínu,
English: Genotype 4, treatment-naïve or treatment-experienced2, with compensated cirrhosis or without cirrhosis
Slovak: Genotyp 4, „naivní“ pacienti alebo pacienti po predchádzajúcej liečbe4, s kompenzovanou cirhózou alebo bez cirhózy
English: The planned total duration of HCV
Slovak: Všetky genotypy HCV
English: 1 Superior versus historical control rate (historical SVR rates of approved combination treatments of direct acting antivirals with peginterferon alfa and ribavirin).
Slovak: Genotyp 1a s Q80K bez Q80K Genotyp 1b 1 Superior oproti historickej miere kontroly (miera historickej SVR schválenej kombinovanej liečby priamo účinkujúcich antivirotík s peginterferónom alfa and ribavirínom).
English: Outcome for patients without SVR12 On-treatment failure Viral relapse2
Slovak: Výsledok u pacientov bez SVR12
English: D168V
Slovak: R155K
English: ANTIDEPRESSANTS Escitalopram 10 mg once daily escitalopram AUC 1.00 (0.97-1.03) ↔ escitalopram Cmax 1.03 (0.99-1.07) ↔ escitalopram Cmin 1.00 (0.95-1.05) ↔ simeprevir AUC 0.75 (0.68-0.83) ↓ simeprevir Cmax 0.80 (0.71-0.89) ↓ simeprevir Cmin 0.68 (0.59-0.79) ↓
Slovak: ANTIDEPRESÍVA Escitalopram 10 mg jedenkrát denne escitalopram AUC 1,00 (0,97-1,03)
English: The proportion of simeprevir-treated patients with HCV RNA < 25 IU/ml detectable at week 4 was 14% (70/509); 67% achieved SVR12.
Slovak: HCV RNA v 4. týždni; u týchto pacientov bol podiel SVR12 90 %. Podiel pacientov liečených simeprevirom s detekovateľnou HCV RNA < 25 IU/ml v 4. týždni bol 14
English: (intestinal CYP3A4 enzyme inhibition)
Slovak: (inhibícia enzýmu CYP3A4)
English: - carbamazepine, oxcarbazepine, phenobarbital or phenytoin to prevent seizures - astemizole or terfenadine to treat allergies - itraconazole, fluconazole, ketoconazole, posaconazole or voriconazole (when taken by mouth or given by injection) to treat fungal infections - rifabutin, rifampicin or rifapentine to treat infections like tuberculosis - amlodipine, bepridil, diltiazem, felodipine, nicardipine, nifedipine, nisoldipine or verapamil
Slovak: - karbamazepín, oxkarbazepín, fenobarbital alebo fenytoín na prevenciu epileptických záchvatov - astemizol alebo terfenadín na liečbu alergií
English: The response rates for patients with or without cirrhosis receiving 12 weeks of simeprevir + sofosbuvir are shown in table 13.
Slovak: Miera odpovede pacientov s cirhózou alebo bez cirhózy, ktorí dostávali 12 týždňov simeprevir
English: Simeprevir in combination with peginterferon alfa and ribavirin There were no differences in haemoglobin, neutrophils or platelets between both treatment groups.
Slovak: Medzi oboma liečebnými skupinami sa nezaznamenali žiadne rozdiely v hladine hemoglobínu, neutrofilov alebo krvných doštičiek.
English: Consult the Summary of Product Characteristics of the co-prescribed medicinal products before starting therapy with OLYSIO.
Slovak: Pred začatím liečby OLYSIOM si treba pozrieť súhrn charakteristických vlastností súbežne predpísaných liekov.
English: ciclosporin AUC 1.19 (1.13-1.26) ↑ ciclosporin Cmax 1.16 (1.07-1.26) ↑ ciclosporin Cmin not studied simeprevir AUC 5.81 (3.56-9.48) ↑5 simeprevir Cmax 4.74 (3.12-7.18) ↑5 simeprevir Cmin not studied5
Slovak: Cmin nesledovala sa simeprevir AUC 5,81 (3,56-9,48)
English: Genotype 1a1 N = 116 % (n)
Slovak: Genotyp 1 (N =
English: Genotype 1, prior relapsers2, with compensated cirrhosis or without cirrhosis
Slovak: 1, pacienti s recidívou v minulosti2, s kompenzovanou cirhózou alebo bez cirhózy
English: or amiodarone to treat irregular heart beat - clarithromycin, erythromycin (when taken by mouth or given by injection) or telithromycin to treat bacterial infections - warfarin and other similar medicines called vitamin K antagonists used to thin the blood.
Slovak: - warfarín a iné podobné lieky, ktoré sa nazývajú antagonisty vitamínu K, ktoré sa používajú na riedenie krvi.
English: 600 mg once daily efavirenz AUC 0.90 (0.85-0.95) ↔ efavirenz Cmax 0.97 (0.89-1.06) ↔ efavirenz Cmin 0.87 (0.81-0.93) ↔ simeprevir AUC 0.29 (0.26-0.33) ↓ simeprevir Cmax 0.49 (0.44-0.54) ↓ simeprevir Cmin 0.09 (0.08-0.12) ↓
Slovak: 600 mg jedenkrát denne efavirenz AUC 0,90 (0,85-0,95)
English: Testing for the presence of the Q80K polymorphism in patients with HCV genotype 1a is strongly recommended when considering therapy with OLYSIO in combination with peginterferon alfa and ribavirin.
Slovak: Keď sa zvažuje liečba OLYSIOM v kombinácii s peginterferónom alfa a ribavirínom, dôrazne sa odporúča u pacientov s HCV genotypu 1a skontrolovať prítomnosť polymorfizmu Q80K.
English: All HCV genotypes N = 197 % (n)
Slovak: 7) Genotyp 6 (N =
English: (mild to moderate CYP3A4 enzyme inhibition)
Slovak: (mierna až stredne silná inhibícia enzýmu CYP3A4)
English: If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
Slovak: Ak vám lekár povedal, že neznášate niektoré druhy cukrov,
English: Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health
Slovak: Článok 29 smernice 2001/83/ES v znení zmien a doplnení, postúpenie veci z dôvodu potenciálneho závažného rizika pre verejné zdravie.
English: The company wanted the authorisation to be recognised in Belgium, Germany, Italy, Spain, Sweden and the United Kingdom (the ‘concerned Member States').
Slovak: Spoločnosť chcela, aby bolo povolenie uznané aj v Belgicku, Nemecku, Taliansku, Španielsku, Švédsku a v Spojenom kráľovstve (tzv. dotknuté členské štáty).
English: Dr Robert James Hemmings
Slovak: Robert James Hemmings dr.
English: Prof. Pieter de Graeff
Slovak: Pieter de Graeff dr.
English: Referral start date:
Slovak: Dátum začatia postupu:
English: Questions and answers on the referral for Ciclosporin IDL and associated names capsules containing ciclosporin 25 mg, 50 mg and 100 mg
Slovak: Otázky a odpovede týkajúce sa konania pre liek Ciclosporin IDL a súvisiace názvy kapsuly s obsahom ciklosporínu 25 mg, 50 mg a 100 mg
English: However, because the concerned Member States were not able to reach an agreement, the Dutch medicines regulatory agency referred the matter to the CHMP for arbitration on 2 December 2008.
Slovak: Dotknuté členské štáty však neboli schopné dosiahnuť dohodu a holandská agentúra pre dohľad nad liekmi 2. decembra 2008 postúpila výboru CHMP túto vec na arbitrážne konanie.
English: The company International Drug Licensing (IDL) submitted Ciclosporin IDL for mutual recognition on the basis of the initial authorisation granted by the Netherlands on 10 August 2007.
Slovak: Spoločnosť International Drug Licensing (IDL) predložila liek Ciclosporin IDL na vzájomné uznanie na základe pôvodného povolenia, ktoré vydalo Holandsko 10. augusta 2007.
English: Ref. EMEA/CHMP/71684/2009 EMEA/H/A-29/1105
Slovak: EMEA/H/A-29/1105
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP was of the opinion that bioequivalence between Ciclosporin IDL and the reference medicine had not been sufficiently demonstrated.
Slovak: Na základe hodnotenia v súčasnosti dostupných údajov a odbornej rozpravy vo výbore sa výbor CHMP domnieva, že biologická rovnocennosť medzi liekom Ciclosporin IDL a referenčným liekom nebola preukázaná v dostatočnej miere.
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Ciclosporin IDL.
Slovak: Európska agentúra pre lieky ukončila arbitrážne konanie na základe nezhody medzi členskými štátmi Európskej únie (EÚ) týkajúcej sa povolenia lieku Ciclosporin ILD.
English: London, 23 April 2009 Doc.
Slovak: Londýn 22. júla 2010 Dok. č..
English: Ciclosporin IDL is also used to treat autoimmune diseases.
Slovak: Okrem toho sa liek Ciclosporin IDL používa aj na liečbu autoimúnnych chorôb.
English: Co-rapporteur(s):
Slovak: Spolupracujúci spravodajca:
English: It is used in patients who have had a transplant, to prevent rejection (when the immune system attacks the transplanted organ).
Slovak: Používa sa u pacientov s transplantovaným orgánom, aby sa predišlo odmietnutiu orgánu (ak imunitný systém napadne transplantovaný orgán).
English: Why was Ciclosporin IDL reviewed?
Slovak: Prečo bol liek Ciclosporin IDL opätovné skúmaný?
English: In addition the Committee has also recommended that the marketing authorisation for Ciclosporin IDL in the Netherlands and other member states in the EU where the product has been authorised should be suspended until satisfactory bioequivalence data are obtained.
Slovak: Okrem toho výbor tiež odporučil, aby bola platnosť povolenia na uvedenie lieku Ciclosporin IDL pozastavená v Holandsku a ostatných členských štátoch EÚ, kde je tento liek povolený, pokiaľ nebudú k dispozícii dostatočné údaje o biologickej rovnocennosti.
English: The grounds for the referral were that five of the concerned Member States did not agree that enough evidence had been presented to show that Ciclosporin IDL was ‘bioequivalent' to the reference medicine.
Slovak: Postúpenie veci bolo zdôvodnené skutočnosťou, že päť z dotknutých členských štátov tvrdilo, že nebol predložený dostatok dôkazov o tom, že liek Ciclosporin IDL je biologicky rovnocenný s referenčným liekom.
English: What is Ciclosporin IDL?
Slovak: Čo je liek Ciclosporin IDL?
English: It is also used to treat or prevent graft-versus-host disease (when the immune system of the transplanted organ attacks the patient's tissues).
Slovak: Používa sa aj na liečbu alebo prevenciu choroby reakcie štepu proti hostiteľovi (ak imunitný systém transplantovaného orgánu napadne tkanivo pacienta).