FrancophonIA/ELRC3.0 huggingface dataset:
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;
Slovenian: 167 vključenih bolnikov je imelo mediano starost 57 let (razpon 27 do 70 let; 5% starejših od 65 let); 64% je bilo moških, 81% belcev, 19% črne rase ali afroameričanov in 21% latinskoameriške etnične skupine; 37% jih je imelo ITM ≥ 30 kg/m2; mediana izhodiščne koncentracije HCV RNK je bila 6,7 log10 i.e./ml; 75% ni imelo ciroze (ocena fibroze po klasifikaciji METAVIR F0-3), 25% jih je imelo cirozo (ocena fibroze po klasifikaciji METAVIR F4); 78% je bilo okuženih s HCV genotipa 1a, od katerih jih je 45% imelo polimorfizem Q80K ob začetku študije, 22% je bilo okuženih s HCV genotipa 1b, 86% jih je imelo ne- CC IL28B alele (CT ali TT), 76% bolnikov se ni odzvalo na predhodno zdravljenje s peginterferonom alfa in ribavirinom in 24% jih še ni prejemalo zdravljenja.
English: (strong CYP3A4 enzyme inhibition)
Slovenian: (močna indukcija CYP3A4)
English: Plasma protein binding is not meaningfully altered in patients with
Slovenian: Pri bolnikih z okvaro ledvic ali jeter ne prihaja do bistvenih sprememb glede
English: Eighty-nine percent (51/57) of the simeprevir-treated treatment-naïve patients and prior relapsers were eligible for a total treatment duration of 24 weeks; in these patients the SVR12 rate was 94%.
Slovenian: Devetinosemdeset odstotkov (51/57) bolnikov, ki so prejemali simeprevir in predhodno še niso bili zdravljeni ali se je po predhodnem zdravljenju bolezen ponovila, je bilo primernih za skupno trajanje zdravljenja 24 tednov.
English: Simeprevir in combination with peginterferon alfa and ribavirin: During the 12 weeks treatment with simeprevir, ‘blood bilirubin increased' was reported in 7.4% of simeprevir-treated patients, compared to 2.8% in placebo-treated patients (all grades; pooled phase 3).
Slovenian: Simeprevir v kombinaciji s peginterferonom alfa in ribavirinom: med 12 tedenskim zdravljenjem s simeprevirjem so o zvečanju koncentracije bilirubina v krvi poročali pri 7,4% bolnikov, ki so se zdravili s simeprevirjem, v primerjavi z 2,8% bolnikov, ki so prejemali placebo (vse stopnje, združeni podatki iz študij faze 3).
English: Increased plasma concentrations of
Slovenian: zvečanje koncentracije peroralnih zaviralcev
English: The Q80K polymorphism was not observed in patients with genotype 4 infection.
Slovenian: Pri bolnikih, okuženih s HCV genotipa 4, polimorfizma Q80K niso opažali.
English: Felodipine
Slovenian: Dojenje
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.
Slovenian: Zdravljenje z zdravilom OLYSIO je treba uvesti in 12 tednov dajati v kombinaciji s peginterferonom alfa in ribavirinom.
English: Treatment-experienced to prior treatment with peginterferon and ribavirin.
Slovenian: Podatki o predhodnem zdravljenju predhodno nezdravljeni predhodno zdravljeni s peginterferonom alfa in ribavirinom
English: Simeprevir in combination with peginterferon alfa and ribavirin: During the first 12 weeks treatment with simeprevir, dyspnoea was reported in 11.8% of simeprevir-treated patients, compared to 7.6% in placebo-treated patients (all grades; pooled phase 3).
Slovenian: Simeprevir v kombinaciji s peginterferonom alfa in ribavirinom: Med-12 tedenskim zdravljenjem s simeprevirjem so o dispneji poročali pri 11,8% bolnikov, ki so se zdravili s simeprevirjem, v primerjavi z 7,6% bolnikov, ki so prejemali placebo (vse stopnje, združeni podatki iz študij faze 3).
English: HCV geno/subtype and presence of Q80K polymorphism in HCV genotype 1a with Q80K without Q80K Genotype 1b
Slovenian: HCV geno/podtip in prisotnost polimorfizma Q80K ob izhodišču pri HCV genotipa 1 HCV genotipa 1a s Q80K
English: Antiretroviral - protease inhibitors (PIs)
Slovenian: Protiretrovirusna zdravila - zaviralci proteaze (PI) darunavir/ritonavir
English: It is not recommended to co-administer OLYSIO with cobicistat-containing medicinal products.
Slovenian: Sočasna uporaba zdravila OLYSIO z zdravili, ki vsebujejo kobicistat, ni priporočljiva.
English: The interaction between simeprevir and the medicinal product was evaluated in a phase 2 pharmacokinetic study in 20 HCV-infected patients.
Slovenian: Medsebojno delovanje med simeprevirjem in tem zdravilom so ocenjevali v farmakokinetični študiji faze 2 pri
English: In HCV genotype 1a infected patients with cirrhosis, testing for the presence of the Q80K polymorphism may be considered prior to initiation of therapy with OLYSIO in combination with sofosbuvir (see section 4.4).
Slovenian: Pred začetkom zdravljenja z zdravilom OLYSIO v kombinaciji s sofosbuvirjem lahko pri bolnikih s cirozo, okuženih s HCV genotipa 1a razmislite o testiranju na prisotnost polimorfizma Q80K (glejte poglavje 4.4).
English: - milk thistle (a herbal medicine) for liver problems - St John's wort (Hypericum perforatum, a herbal medicine) for anxiety or depression - ledipasvir to treat hepatitis C infection - cobicistat to increase levels of some medicines used to treat HIV infection - atazanavir, darunavir, delavirdine, efavirenz, etravirine, fosamprenavir, indinavir, lopinavir,
Slovenian: zdravljenje vnetnih ali avtoimunskih bolezni - cisaprid za zdravljenje težav z želodcem - pegasti badelj (zdravilo rastlinskega izvora) za zdravljenje težav z jetri - šentjanževka (Hypericum perforatum, zdravilo rastlinskega izvora) za zdravljenje tesnobe in
English: Hepatic decompensation and hepatic failure, including fatal cases, have been reported post-marketing in patients treated with OLYSIO in combination with peginterferon alfa and ribavirin and in combination with sofosbuvir.
Slovenian: V obdobju trženja zdravila so pri bolnikih, ki so zdravilo OLYSIO prejemali v kombinaciji s peginterferonom alfa in ribavirinom ali v kombinaciji s sofosbuvirjem, poročali o dekompenzaciji in odpovedi jeter, vključno s smrtnimi primeri.
English: Antibiotics - macrolides (systemic administration) Azithromycin
Slovenian: Antibiotiki - makrolidi (sistemska uporaba) Niso preučevali.
English: HCV genotype 1 subtype-specific patterns of simeprevir treatment-emergent amino acid substitutions were observed in patients not achieving SVR.
Slovenian: Pri bolnikih, ki niso dosegli SVR, so opažali vzorec substitucij aminokislin, ki ga je povzročilo zdravljenje s simeprevirjem in je bil specifičen za podtip HCV genotipa 1.
English: Phase 3 study in Asian patients
Slovenian: Združeni podatki študij faze 3
English: Simeprevir in combination with peginterferon alfa and ribavirin There were no differences in haemoglobin, neutrophils or platelets between both treatment groups.
Slovenian: Koncentracije hemoglobina, število nevtrofilcev oziroma trombocitov se med obema študijskima skupinama niso razlikovale.
English: Efficacy in patients with HCV genotype 1 and HIV-1 co-infection In study C212, patients with HIV-1 co-infection who were treatment-naïve or failed prior peg-IFN/RBV therapy received simeprevir (150 mg once daily) + peginterferon alfa-2a + ribavirin for 12 weeks, followed by 12 or 36 additional weeks of peginterferon alfa-2a + ribavirin (see tables 17 and 18).
Slovenian: V študiji C212 so bolniki s sočasno okužbo s HIV-1, ki še niso bili zdravljeni ali pri katerih predhodno zdravljenje s peg-IFN/RBV ni bilo uspešno, 12 tednov prejemali simeprevir (150 mg enkrat na dan) + peginterferon alfa-2a + ribavirin, nato pa naslednjih 12 ali 36 tednov peginterferon alfa-2a + ribavirin (glejte preglednici 17 in 18).
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.
Slovenian: Pri bolnikih, okuženih s HCV genotipa 1a se pred zdravljenjem z zdravilom OLYSIO v kombinaciji s peginterferonom alfa in ribavirinom močno priporoča testiranje na prisotnost polimorfizma Q80K.
English: Efficacy in patients with HCV genotype 4 infection In study HPC3011 (RESTORE), patients who were treatment-naïve or failed prior peg-IFN/RBV therapy received simeprevir (150 mg once daily) + peginterferon alfa-2a + ribavirin for 12 weeks, followed by 12 or 36 additional weeks of peginterferon alfa-2a + ribavirin (see tables 17 and 18).
Slovenian: V študiji HPC3011 (RESTORE) so še nezdravljeni bolniki ali bolniki, pri katerih predhodno zdravljenje s peg-IFN/RBV ni bilo uspešno, 12 tednov prejemali simeprevir (150 mg enkrat na dan) + peginterferon alfa-2a + ribavirin, nato pa naslednjih 12 ali 36 tednov peginterferon alfa-2a + ribavirin (glejte preglednici 17 in 18).
English: Discontinue peginterferon alfa and ribavirin
Slovenian: 1 ukinite zdravljenje s peginterferonom alfa in ribavirinom
English: Gender had no clinically relevant effect on the pharmacokinetics of simeprevir based on a population pharmacokinetic analysis of HCV infected patients treated with simeprevir in combination with peginterferon alfa and ribavirin.
Slovenian: Po podatkih populacijske farmakokinetične analize bolnikov, ki so okuženi s HCV in so prejemali zdravilo simeprevir v kombinaciji s peginterferonom alfa in ribavirinom, spol ni klinično pomembno vplival na farmakokinetiko simeprevirja.
English: Table 14 shows the response rates for patients without cirrhosis (METAVIR scores F0-3) receiving 12 weeks of simeprevir +sofosbuvir with or without ribavirin; extending treatment to 24 weeks did not increase response rates in comparison with 12 weeks treatment.
Slovenian: V preglednici 14 so prikazane stopnje odziva bolnikov brez ciroze (ocena po klasifikaciji METAVIR F0-3), ki so 12 tednov prejemali simeprevir +sofosbuvir, z ribavirinom ali brez ribavirina.
English: Erythromycin 500 mg three times a day erythromycin AUC 1.90 (1.53-2.36) ↑ erythromycin Cmax 1.59 (1.23-2.05) ↑ erythromycin Cmin 3.08 (2.54-3.73) ↑ simeprevir AUC 7.47 (6.41-8.70) ↑ simeprevir Cmax 4.53 (3.91-5.25) ↑ simeprevir Cmin 12.74 (10.19-15.93) ↑
Slovenian: AUC darunavirja 1,18 (1,11-1,25)  Cmax darunavirja 1,04 (0,99-1,10) ↔ Cmin darunavirja 1,31 (1,13-1,52)  AUC ritonavirja 1,32 (1,25-1,40)  Cmax ritonavirja 1,23 (1,14-1,32)  Cmin ritonavirja 1,44 (1,30-1,61)  AUC simeprevirja 2,59 (2,15-3,11) * Cmax simeprevirja 1,79 (1,55-2,06) *
English: Efficacy in treatment-experienced patients with HCV genotype 1 infection In study HPC3007 (PROMISE), patients who relapsed after prior IFN-based therapy received simeprevir (150 mg once daily) + peginterferon alfa-2a + ribavirin for 12 weeks, followed by 12 or 36 additional weeks of peginterferon alfa-2a + ribavirin (see tables 17 and 18).
Slovenian: V študiji HPC3007 (PROMISE) so bolniki s ponovitvijo bolezni po predhodnem zdravljenju na podlagi IFN 12 tednov prejemali simeprevir (150 mg enkrat na dan) + peginterferon alfa-2a + ribavirin, nato pa naslednjih 12 ali 36 tednov peginterferon alfa-2a + ribavirin (glejte preglednici 17 in
English: SOC
Slovenian: CC
English: 25-desacetyl-rifampicin AUC 1.24 (1.13-1.36) ↑ 25-desacetyl-rifampicin Cmax 1.08 (0.98-1.19) ↔
Slovenian: AUC raltegravirja 1,08 (0,85-1,38)  Cmax raltegravirja 1,03 (0,78-1,36) ↔
English: It is not recommended to co-administer OLYSIO with rifampicin as co-administration may result in loss of therapeutic effect of OLYSIO.
Slovenian: Sočasna uporaba rifampicina z zdravilom OLYSIO ni priporočljiva, saj lahko povzroči izgubo terapevtskega učinka zdravila OLYSIO.
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%.
Slovenian: Sedeminsedemdeset odstotkov (200/259) bolnikov, ki so prejemali simeprevir, je imelo po 4 tednih nezaznavno koncentracijo HCV RNK.
English: Discontinue OLYSIO, peginterferon alfa and ribavirin
Slovenian: Simeprevir v kombinaciji s peginterferonom alfa in ribavirinom
English: It is not recommended to co-administer OLYSIO with ciclosporin.
Slovenian: Sočasna uporaba zdravila OLYSIO in ciklosporina ni priporočljiva.
English: In HCV genotype 1a infected patients without cirrhosis, simeprevir efficacy in combination with sofosbuvir at the recommended 12-week treatment duration was not impacted by the presence of the NS3 Q80K polymorphism (see section 5.1).
Slovenian: Prisotnost polimorfizma NS3 Q80K (glejte poglavje 5.1), pri bolnikih s HCV genotipa 1 brez ciroze ni vplivala na učinkovitost simeprevirja v kombinaciji s sofosbuvirjem med priporočenim 12-tedenskem
English: Table 22: Treatment outcome in HCV genotype 1 infected patients with HIV-1 co-infection
Slovenian: Preglednica 22: Izid zdravljenja pri bolnikih, okuženih s HCV genotipa 1 in s sočasno okužbo s HIV-1 (študija C212)
English: What OLYSIO contains - The active substance is simeprevir.
Slovenian: - Zdravilo OLYSIO vsebuje zdravilno učinkovino simeprevir.
English: (inhibition of CYP3A4 enzymes and P-gp transporter by both erythromycin and simeprevir)
Slovenian: (zaviranje CYP3A4 in prenašalca P-gp v amlodipinom in zmernega zaviranja CYP3A4
English: In study HPC2002, rash (grouped term) was reported in 10.7% of patients receiving 12 weeks of simeprevir and sofosbuvir without ribavirin versus 20.4% of patients receiving 12 weeks of simeprevir
Slovenian: Med 12-tedenskim zdravljenjem s simeprevirjem v kombinaciji s sofosbuvirjem brez ribavirina v študiji HPC2002 so o izpuščaju (skupni termin) poročali pri 10,7% bolnikov v primerjavi z 20,4% bolnikov, ki so 12 tednov prejemali simeprevir v kombinaciji s sofosbuvirjem in ribavirinom.
English: Elimination of simeprevir occurs via biliary excretion.
Slovenian: Simeprevir se izloča z žolčem.
English: OLYSIO must always be used as part of a course of treatment with other medicines for treating chronic hepatitis C infection.
Slovenian: Zdravilo OLYSIO je treba med zdravljenjem vedno jemati skupaj z drugimi zdravili za zdravljenje kronične okužbe s hepatitisom C. Zato je pomembno, da pred začetkom zdravljenja z zdravilom OLYSIO preberete tudi navodila za uporabo, priložena drugim zdravilom.
English: No dose adjustment is required for either drug when OLYSIO is co-administered with maraviroc.
Slovenian: Pri sočasni uporabi zdravila OLYSIO z maravirokom ni potrebno prilagajati odmerjanja nobenega od obeh zdravil.
English: 2-OH-atorvastatin AUC 2.29 (2.08-2.52) ↑ 2-OH-atorvastatin Cmax 1.98 (1.70-2.31) ↑
Slovenian: AUC atorvastatina 2,12 (1,72-2,62)  Cmax atorvastatina 1,70 (1,42-2,04)  Cmin atorvastatina niso proučevali AUC 2-OH-atorvastatina 2,29 (2,08-2,52)  Cmax 2-OH-atorvastatina 1,98 (1,70-2,31)  Cmin 2-OH-atorvastatina niso preučevali
English: These characteristics have no clinically relevant effect on the pharmacokinetics of simeprevir based on a population pharmacokinetic analysis of HCV infected patients treated with simeprevir in combination with peginterferon alfa and ribavirin.
Slovenian: Po podatkih populacijske farmakokinetične analize bolnikov, ki so okuženi s HCV in so prejemali zdravilo simeprevir v kombinaciji s peginterferonom alfa in ribavirinom, navedeni karakteristiki nista klinično pomembno vplivali na farmakokinetiko simeprevirja.
English: Treatment-naïve and prior relapse patients
Slovenian: genotip 1, nezdravljeni ali že zdravljeni bolniki
English: BLISTER
Slovenian: sirolimus
English: Simeprevir is highly protein bound, therefore dialysis is unlikely to result in significant removal of
Slovenian: Simeprevir se obsežno veže na beljakovine, zato ga z dializo po vsej verjetnosti ni mogoče v večji meri odstraniti iz telesa (glejte poglavje 5.2).
English: Rilpivirine 25 mg once daily rilpivirine AUC 1.12 (1.05-1.19) ↔ rilpivirine Cmax 1.04 (0.95-1.13) ↔
Slovenian: Cmax 25-dezacetil-rifampicina 1,08 (0,98-1,19)
English: HCV geno/subtype and presence of Q80K polymorphism in HCV genotype 1a
Slovenian: HCV geno/podtip in prisotnost polimorfizma Q80K ob izhodišču pri HCV genotipa 1a
English: Increased simeprevir concentrations may occur due to inhibition of OATP1B1 by atorvastatin.
Slovenian: Zaradi zaviranja OATP1B1 z atorvastatinom se lahko pričakuje zvečanje koncentracij
English: (intestinal CYP3A4 enzyme inhibition)
Slovenian: (zaviranje CYP3A4 v črevesju)
English: * Skin rash may affect more than 1 in 10 people (very common) when OLYSIO is used in combination with sofosbuvir for 24 weeks.
Slovenian: - občutljivost kože na sončno svetlobo (fotosenzitivnost) - zvečana koncentracija bilirubina v krvi (bilirubin je barvilo, ki nastaja v jetrih) * Kadar se zdravilo OLYSIO v kombinaciji s sofosbuvirjem jemlje 24 tednov, se kožni izpuščaj lahko pojavi pri več kot 1 od 10 bolnikov (zelo pogosto).
English: Race
Slovenian: Rasna pripadnost
English: Titrate the rosuvastatin dose carefully and use the lowest necessary dose while monitoring for safety when co-administered with OLYSIO.
Slovenian: Pri sočasni uporabi z zdravilom OLYSIO previdno titrirajte odmerek rosuvastatina in uporabljajte najnižji odmerek, ki je potreben, pri tem pa spremljajte varnost sočasnega odmerjanja.
English: Frequency Category simeprevir + sofosbuvir simeprevir + peginterferon alfa + ribavirin N = 781
Slovenian: Okvir posamezne stopnje simeprevir + peginterferon alfa + ribavirin N = 781 n (%)
English: Chemistry Amylase
Slovenian: Shranjevanje zdravila OLYSIO
English: Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε.
Slovenian: Janssen-Cilag AB c/o Vistor hf.
English: - digoxin, disopyramide, flecainide, mexiletine, propafenone or quinidine (when taken by mouth)
Slovenian: emtricitabin, lamivudin, stavudin, zidovudin)
English: Titrate the atorvastatin dose carefully and use the lowest necessary dose while monitoring for safety when co-administered with OLYSIO.
Slovenian: Pri sočasni uporabi z zdravilom OLYSIO previdno titrirajte odmerek atorvastatina in uporabljajte najnižji odmerek, ki je potreben, pri tem pa spremljajte varnost sočasnega odmerjanja.
English: No dose adjustment of OLYSIO is required in patients with mild hepatic impairment (Child-Pugh A).
Slovenian: Pri bolnikih z blago okvaro jeter (razred A po Child-Pughu) prilagajanje odmerkov zdravila OLYSIO ni potrebno.
English: Rīga, LV-1004
Slovenian: Karla Engliše 3201/06
English: Viral relapse rates are calculated with a denominator of patients with undetectable (or unconfirmed detectable)
Slovenian: Ponovitev bolezni je izračunana na podlagi imenovalca, ki predstavlja število bolnikov z nezaznavno (ali nepotrjeno zaznavno) koncentracijo HCV RNK ob zaključku zdravljenja.
English: Titrate the simvastatin dose carefully and use the lowest necessary dose while monitoring for safety when co-administered with OLYSIO.
Slovenian: Pri sočasni uporabi z zdravilom OLYSIO previdno titrirajte odmerek simvastatina in uporabljajte najnižji odmerek, ki je potreben, pri tem pa spremljajte varnost sočasnega odmerjanja.
English: DXM Cmin not studied dextrorphan AUC 1.09 (1.03-1.15) ↔ dextrorphan Cmax 1.03 (0.93-1.15) ↔ dextrorphan Cmin not studied
Slovenian: AUC rifampicina 1,00 (0,93-1,08) ↔ Cmax rifampicina 0,92 (0,80-1,07) ↔ Cmin rifampicina niso preučevali AUC 25-dezacetil-rifampicina 1,24 (1,13-1,36)
English: The proportion of simeprevir-treated patients with HCV RNA < 25 IU/ml detectable at week 4 was 18% (47/259); 60% achieved SVR12.
Slovenian: Delež bolnikov, zdravljenih s simeprevirjem, s koncentracijo HCV RNK < 25 i.e./ml, zaznavno po 4 tednih, je bil 18%
English: No effects on fertility were observed
Slovenian: V študijah na živalih niso opazili vpliva na
English: No dose adjustment is required for either drug when OLYSIO is co-administered with tacrolimus.
Slovenian: Pri sočasni uporabi zdravila OLYSIO in takrolimusa prilagajanje odmerkov ni potrebno.
English: Refer also to the Summary of Product Characteristics of the medicinal products that are used in
Slovenian: Glejte tudi povzetek glavnih značilnosti zdravila za ribavirin.
English: Table 19 shows the response rates in HCV genotype 1 infected treatment-naïve patients.
Slovenian: V preglednici 19 so prikazane stopnje posameznih odzivov v času zdravljenja pri bolnikih, okuženih s HCV genotipa 1, ki predhodno niso bili zdravljeni.
English: Refer to the respective Summary of Product Characteristics of the medicinal products used in combination with simeprevir regarding their use in patients with renal impairment.
Slovenian: Glede uporabe zdravil, ki se uporabljajo v kombinaciji s simeprevirjem pri bolnikih z okvaro jeter glejte ustrezen Povzetek glavnih značilnosti posameznega zdravila.
English: Study
Slovenian: Glejte
English: HCV/HIV-1 co-infected patients.
Slovenian: Bolniki, sočasno okuženi z virusom HIV-1
English: It is not recommended to co-administer OLYSIO with products containing St John's wort as co-administration may result in loss of therapeutic effect of OLYSIO.
Slovenian: Sočasna uporaba zdravila OLYSIO s pripravki, ki vsebujejo šentjanževko, ni priporočljiva, saj lahko povzroči izgubo terapevtskega učinka zdravila OLYSIO.
English: Respiratory, thoracic and mediastinal disorders: very common dyspnoea*
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora:
English: When considering OLYSIO combination treatment with peginterferon alfa and ribavirin in HCV genotype 1a patients, patients should be tested for the presence of virus with the NS3 Q80K polymorphism before starting treatment (see section 4.4).
Slovenian: Kadar se odločate za zdravilo OLYSIO skupaj s peginterferonom alfa in ribavirinom, je treba bolnike s HCV genotipa 1 pred začetkom zdravljenja testirati na prisotnost polimorfizma
English: The RMP shall include the following:
Slovenian: RMP mora vključevati naslednje:
English: Elderly patients aged 65 years and over
Slovenian: Starejši bolniki, stari 65 let ali več
English: Some side effects can be serious:
Slovenian: Nekateri neželeni učinki so lahko resni:
English: - Second and third trimesters of pregnancy (see section 4.6).
Slovenian: - Drugo in tretje trimesečje nosečnosti (glejte poglavje 4.6).
English: Before you drive a vehicle, use machinery, or carry out other activities that require concentration, you should make sure you know how you react to the effects of this medicine.
Slovenian: Preden se namenite upravljati vozilo, uporabljati stroje ali opravljati druge dejavnosti, ki zahtevajo zbranost, morate dobro poznati svoj odziv na učinke tega zdravila.
English: Within a month following the Commission Decision of the renewal procedure
Slovenian: V roku enega meseca po Odločbi Komisije o postopku podaljšanja dovoljenja za promet.
English: Date of first authorisation: 22 August 2007 Date of latest renewal:
Slovenian: Datum prve odobritve: 22. avgust 2007 Datum zadnjega podaljšanja: 24. avgust 2012
English: Riprazo helps to lower high blood pressure in adult patients.
Slovenian: Riprazo pomaga zniževati visok krvni tlak pri odraslih bolnikih.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: In addition, an updated RMP should be submitted within 1 month after the Commission Decision of the renewal procedure.
Slovenian: Poleg tega je treba posodobljen RMP predložiti v obdobju 1 meseca po Odločbi Komisije o postopku podaljšanja dovoljenja za promet.
English: What you need to know before you take Riprazo
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Riprazo
English: Any unused medicinal product or waste material should be disposed of in accordance with local
Slovenian: Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: The tablets should be swallowed whole with some water.
Slovenian: Tablete je treba pogoltniti cele z malo vode.
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being
Slovenian: • v 60 dneh po doseženem pomembnem mejniku (farmakovigilančnem ali povezanem z zmanjševanjem tveganja),
English: The PSUR cycle for the medicinal product should follow the yearly cycle until otherwise agreed by the CHMP.
Slovenian: Cikel PSUR za zdravilo mora slediti letnemu ciklu dokler CHMP ne odloči drugače.