FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, therapy with Stribild should not be initiated during pregnancy, and women who become pregnant during therapy with Stribild should be switched to an alternative regimen (see sections 4.2 and 4.6).
Slovenian: Zato se zdravljenje z zdravilom Stribild ne sme uvesti med nosečnostjo; ženske, ki med zdravljenjem z zdravilom Stribild zanosijo, morajo preiti na drug režim (glejte poglavji 4.2 in 4.6).
English: Renal adverse reactions consistent with proximal renal tubulopathy have been reported in HIV-1 infected paediatric patients aged 2 to < 12 years in a clinical study of tenofovir disoproxil (GS-US-104-0352) (see sections 4.8 and 5.1).
Slovenian: Pri pediatričnih bolnikih, okuženih z virusom HIV-1, starih od 2 do < 12 let, so v klinični študiji dizoproksiltenofovirata (GS-US-104-0352) (glejte poglavji 4.8 in 5.1) poročali o neželenih učinkih na ledvice, skladnih s proksimalno ledvično tubulopatijo.
English: Increased plasma concentrations of tenofovir resulting from co-administration of Stribild and ledipasvir/sofosbuvir may increase
Slovenian: Povečane koncentracije tenofovirja v plazmi zaradi sočasne uporabe zdravila Stribild in ledipasvirja/sofosbuvirja lahko povečajo neželene reakcije, povezane z
English: Therefore, therapy with Stribild should not be initiated during pregnancy, and women who become pregnant during therapy with Stribild should be switched to an alternative regimen (see sections 4.2 and 4.4).
Slovenian: Zato se zdravljenje z zdravilom Stribild ne sme uvesti med nosečnostjo; ženske, ki med zdravljenjem z zdravilom Stribild zanosijo, morajo preiti na drug režim (glejte poglavji 4.2 in 4.4).
English: • medicines used to treat pulmonary arterial hypertension:
Slovenian: • zdravila za zdravljenje pljučne arterijske hipertenzije: bosentan
English: HMG CO-A REDUCTASE INHIBITORS Rosuvastatin (10 mg single dose)/Elvitegravir (150 mg single dose)/Cobicistat (150 mg single dose)
Slovenian: rosuvastatin (10 mg enkratni odmerek)/elvitegravir (150 mg enkratni odmerek)/kobicistat (150 mg enkratni odmerek)
English: Clinical monitoring is recommended and a dose decrease may be necessary when these agents are co-administered with Stribild.
Slovenian: Pri sočasni uporabi teh učinkovin z zdravilom Stribild se priporoča klinično spremljanje in morebiti bo potrebno zmanjšanje odmerka.
English: Musculoskeletal and connective tissue disorders: Very common:
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva:
English: lactic acidosis1
Slovenian: laktacidoza1
English: In virologically-suppressed patients
Slovenian: Pri bolnikih z virusno supresijo
English: The Summary of Product Characteristics II.
Slovenian: POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
English: Sofosbuvir: AUC: ↔ Cmax: ↑ 27% Cmin: N/A
Slovenian: sofosbuvir: AUC: ↔ Cmax: ↑ 27 %
English: Dose modifications are not necessary when administered in combination with Stribild.
Slovenian: Odmerka pri dajanju v kombinaciji z zdravilom Stribild ni treba prilagoditi.
English: Sofosbuvir/Velpatasvir (400 mg/100 mg once daily) + Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil (150 mg/150 mg/200 mg/245 mg once daily)
Slovenian: sofosbuvir/velpatasvir (400 mg/100 mg enkrat dnevno) + elvitegravir/kobicistat/ emtricitabin/dizoproksiltenofovirat
English: Clinical monitoring should be made upon co-administration with Stribild.
Slovenian: Pri sočasnem dajanju z zdravilom Stribild je treba uvesti klinično spremljanje.
English: • If you are allergic to elvitegravir, cobicistat, emtricitabine, tenofovir, tenofovir disoproxil,
Slovenian: • Če ste alergični na elvitegravir, kobicistat, emtricitabin, tenofovir, dizoproksiltenofovirat ali katero koli sestavino tega zdravila (navedeno v poglavju 6 tega navodila).
English: (may affect up to 1 in every 1,000 patients treated)
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov, ki se zdravijo)
English: Therapeutic monitoring is recommended upon co-administration with Stribild.
Slovenian: Pri sočasni uporabi z zdravilom Stribild se priporoča terapevtsko spremljanje.
English: BMD Z-scores declined by -0.012 for lumbar spine and by -0.338 for total body in the 64 subjects who were treated with tenofovir disoproxil for 96 weeks.
Slovenian: Z-vrednosti BMD so se pri 64 osebah, ki so se 96 tednov zdravile z dizoproksiltenofoviratom, zmanjšale za -0,012 za ledveno hrbtenico in za -0,338 za celo telo.
English: ANTICONVULSANTS Carbamazepine (200 mg twice daily)/Elvitegravir (150 mg once daily)/Cobicistat (150 mg once daily)
Slovenian: karbamazepin (200 mg dvakrat dnevno)/elvitegravir (150 mg enkrat dnevno)/kobicistat (150 mg enkrat dnevno)
English: A study of pharmacokinetics of cobicistat-boosted elvitegravir was performed in non-HIV-1 infected subjects with severe renal impairment (creatinine clearance below 30 mL/min).
Slovenian: Pri osebah s hudo ledvično okvaro (očistek kreatinina manj kot 30 ml/min) brez okužbe z virusom HIV-1 so izvedli farmakokinetično študijo elvitegravirja, okrepljenega s kobicistatom.
English: NARCOTIC ANALGESICS Methadone/Elvitegravir/Cobicistat Methadone:
Slovenian: Priporočilo glede sočasne uporabe z zdravilom Stribild buprenorfin/nalokson/ elvitegravir/kobicistat buprenorfin:
English: A study of pharmacokinetics of cobicistat-boosted elvitegravir was performed in non-HIV-1 infected subjects with moderate hepatic impairment.
Slovenian: Pri osebah z zmerno jetrno okvaro brez okužbe z virusom HIV-1 so izvedli farmakokinetično študijo elvitegravirja, okrepljenega s kobicistatom.
English: The active substances are elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil.
Slovenian: Učinkovine so elvitegravir, kobicistat, emtricitabin in dizoproksiltenofovirat.
English: Caution is warranted and clinical monitoring is recommended upon co-administration with Stribild.
Slovenian: Pri sočasni uporabi z zdravilom Stribild je potrebna previdnost, priporoča pa se tudi klinično spremljanje.
English: Ledipasvir:
Slovenian: Opazovano: ledipasvir:
English: Tablet core
Slovenian: Obvladovanje ledvične funkcije
English: Co-administration of Stribild and lovastatin and simvastatin is contraindicated (see section 4.3).
Slovenian: Sočasno dajanje zdravila Stribild z lovastatinom oz. simvastatinom je kontraindicirano (glejte poglavje 4.3).
English: 3.1% (95% CI =
Slovenian: 3,1 % (95-odstotni IZ = -3,2 %, 9,4 %)
English: AUC: ↑ 78% Cmin: ↑ 91% Cmax: ↑ 63%
Slovenian: Cmin: ↑ 91 % Cmax: ↑ 63 %
English: If you get any side effects, talk to your doctor or pharmacist.
Slovenian:  Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: (may affect up to 1 in every 100 patients treated)
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov, ki se zdravijo)
English: AUC: ↔ Cmin: ↔ Cmax: ↔
Slovenian: kobicistat: AUC: ↔ Cmin: ↔ Cmax: ↔
English: Virologic success HIV-1 RNA < 50 copies/mL Treatment difference
Slovenian: < 50 kopij/ml Razlika zdravljenja
English: In Study GS-US-236-0103, the mean increase from baseline in CD4+ cell count at Week 48 was 207 cells/mm3 in the Stribild-treated patients and 211 cells/mm3 in the ATV/r+FTC/tenofovir disoproxil-treated patients.
Slovenian: GS-US-236-0103 je bilo povprečno povečanje od začetne vrednosti za CD4+ število celic v 48. tednu 207 celic/mm za bolnike, zdravljene z zdravilom Stribild, in 211 celic/mm za bolnike, zdravljene z
English: Naloxone:
Slovenian: norgestimat:
English: Atorvastatin:
Slovenian: kobicistat:
English: Adverse reactions to Stribild from Phase 3 clinical studies GS-US-236-0102 and GS-US-236-0103 and adverse reactions to treatment with emtricitabine and tenofovir disoproxil from clinical studies and post-marketing experience, when used with other antiretrovirals, are listed in Table 2, below, by body system organ class and highest frequency observed.
Slovenian: Spodaj v preglednici 2 so po organskih sistemih in največji opazovani pogostnosti navedeni neželeni učinki zdravila Stribild iz kliničnih študij faze 3, GS-US-236-0102 in GS-US-236-0103 in neželeni učinki zdravljenja z emtricitabinom in dizoproksiltenofoviratom iz kliničnih študij in izkušenj v obdobju trženja zdravila, pri uporabi z drugimi protiretrovirusnimi zdravili.
English: The safety of tenofovir disoproxil when used with ledipasvir/sofosbuvir and a pharmacokinetic enhancer (e.g. cobicistat) has not been established.
Slovenian: Varnost dizoproksiltenofovirata ob sočasni uporabi z ledipasvirjem/sofosbuvirjem in farmakokinetičnim ojačevalcem (npr. kobicistatom) ni bila ugotovljena.
English: Elvitegravir: AUC: ↔ Cmin: ↑ 36%
Slovenian: elvitegravir: AUC: ↔ Cmax: ↔ Cmin: ↑ 32 %
English: Hepatic impairment
Slovenian: glavobol, omotica
English: The safety of tenofovir disoproxil when used with sofosbuvir/velpatasvir and a pharmacokinetic enhancer (e.g. cobicistat) has not been established.
Slovenian: Varnost dizoproksiltenofovirata ob sočasni uporabi s sofosbuvirjem/velpatasvirjem in farmakokinetičnim ojačevalcem (npr. kobicistatom) ni bila ugotovljena.
English: Ledipasvir/Sofosbuvir (90 mg/400 mg once daily) + Elvitegravir/Cobicistat (150 mg/150 mg once daily)
Slovenian: Priporočilo glede sočasne uporabe z zdravilom Stribild ledipasvir/sofosbuvir (90 mg/400 mg enkrat dnevno) + elvitegravir/kobicistat (150 mg/150 mg enkrat dnevno)
English: AUC: ↑ 43% Cmax:↔
Slovenian: Cmin: ↑ 36 % Cmax: ↔
English: At baseline, mean plasma HIV-1 RNA was 4.60 log10 copies/mL, mean CD4+ cell count 399 cells/mm3 (range, 133-734), and mean CD4+% 20.9% (range, 4.5%-41.1%).
Slovenian: Ob izhodišču je bila povprečna RNA HIV-1 v plazmi 4,60 log10 kopij/ml, povprečno število celic CD4+ je bilo 399 celic/mm
English: Concentrations of warfarin may be affected upon co-administration with Stribild.
Slovenian: Sočasno dajanje z zdravilom Stribild lahko vpliva na koncentracije varfarina.
English: Caution should be exercised, including consideration of dose reduction, when co-administering Stribild with tadalafil for the treatment of pulmonary arterial hypertension.
Slovenian: Pri sočasnem dajanju zdravila Stribild s tadalafilom za zdravljenje pljučne arterijske hipertenzije je potrebna previdnost, vključno z razmislekom o zmanjšanju odmerka.
English: In Study GS-US-236-0121, virologic success rates were: Stribild 93.4% (271 of 290 patients) and SBR 88.1% (126 of 143 patients).
Slovenian: V študiji GS-US-236-0121 so bile stopnje virološkega uspeha: zdravilo Stribild 93,4 % (271 od 290 bolnikov) in SBR 88,1 % (126 od 143 bolnikov) Povprečno povečanje od začetne vrednosti za CD4+ število celic v 48. tednu je bilo 56 celic/mm3 za bolnike, zdravljene z zdravilom Stribild in 58 celic/mm3 za bolnike, zdravljene z NNRTI+FTC/dizoproksiltenofoviratom.
English: Antiviral synergy was maintained for elvitegravir, emtricitabine, and tenofovir when tested in the presence of cobicistat.
Slovenian: Pri testiranju v prisotnosti kobicistata se je protivirusna sinergija za elvitegravir, emtricitabin in tenofovir ohranila.
English: (may affect at least 1 in every 10 patients treated)
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov, ki se zdravijo)
English: 3.0% (95% CI =
Slovenian: 3,0 % (95-odstotni IZ = -1,9 %, 7,8 %)
English: AUC: ↔ Cmax: ↔ Cmin: ↑ 37%
Slovenian: velpatasvir: AUC: ↔ Cmax: ↔ Cmin: ↑ 37 %
English: No clinically relevant pharmacokinetic differences due to gender have been identified for cobicistat-boosted elvitegravir, emtricitabine and tenofovir disoproxil.
Slovenian: Za elvitegravir, ojačan s kobicistatom, emtricitabin in dizoproksiltenofovirat ni bilo identificirane klinično pomembne farmakokinetične razlike glede na spol.
English: No clinically relevant pharmacokinetic differences due to ethnicity have been identified for cobicistat-boosted elvitegravir, emtricitabine and tenofovir disoproxil.
Slovenian: Za elvitegravir, ojačan s kobicistatom, emtricitabin in dizoproksiltenofovirat ni bilo identificirane klinično pomembne farmakokinetične razlike glede na etnično pripadnost.
English: AUC: ↓ 21% Cmin: ↓ 67%
Slovenian: elvitegravir: AUC: ↓ 21 % Cmin: ↓ 67 % Cmax: ↔
English: Virologic failurec
Slovenian: metoprolol timolol
English: Mean changes from baseline BMD Z-scores (height-age adjusted) were −0.09 for lumbar spine and
Slovenian: Povprečna sprememba Z-vrednosti BMD od izhodišča (prilagojena za višino in starost) je bila −0,09 za ledveno hrbtenico in −0,12 za celo telo brez glave v 48. tednu.
English: Baseline disease characteristicsa
Slovenian: Začetne značilnosti boleznia
English: 3.6% (95% CI =
Slovenian: 3,6 % (95-odstotni IZ = -1,6 %, 8,8 %)
English: While you are taking Stribild
Slovenian: Med jemanjem zdravila Stribild
English: Clinical monitoring is recommended upon co-administration of Stribild.
Slovenian: Po sočasnem dajanju zdravila Stribild se priporoča klinično spremljanje.
English: Rifabutin: AUC: ↔
Slovenian: sofosbuvir: AUC: ↔ Cmax: ↔
English: a Patients were stratified by baseline HIV-1 RNA in both studies.
Slovenian: Povprečno zmanjšanje RNA HIV-1 je bilo
English: AUC: ↑ 48% Cmin: ↑ 67%
Slovenian: elvitegravir: AUC: ↑ 48 % Cmin: ↑ 67 % Cmax: ↔
English: Concentrations of trazodone may increase upon co-administration with cobicistat.
Slovenian: Po sočasnem dajanju s kobicistatom se lahko koncentracije trazodona zvišajo.
English: Caution should be exercised when co-administering Stribild with pitavastatin.
Slovenian: Pri sočasnem dajanju zdravila Stribild s pitavastatinom je potrebna previdnost.
English: • weakness
Slovenian: • utrujenost
English: IMMUNOSUPPRESSANTS Ciclosporin
Slovenian: ciklosporin sirolimus takrolimus
English: Apixaban Rivaroxaban Edoxaban
Slovenian: driska, bruhaje, navzea
English: GLUCOCORTICOIDS
Slovenian: GLUKOKORTIKOIDI
English: The mean increase from baseline in CD4+ cell count at Week 48 was 40 cells/mm3 in the Stribild-treated patients and 32 cells/mm3 in the PI+RTV+FTC/tenofovir disoproxil-treated patients.
Slovenian: Stribild in 32 celic/mm za bolnike, zdravljene z PI+RTV+FTC/dizoproksiltenofoviratom.
English: Intramuscular use suspension (H5N1): vial (glass) emulsion (adjuvant): vial (glass)
Slovenian: suspenzija in emulzija za emulzijo za injiciranje intramuskularna uporaba suspenzija (H5N1): viala (steklo) emulzija (adjuvans): viala (steklo)
English: 2.5 ml (emulsion)
Slovenian: 2,5 ml (suspenzija) 2,5 ml (emulzija)
English: Strength Pharmaceutical form Route of administration
Slovenian: (Izmišljeno) ime Jakost Farmacevtska oblika
English: Veralipride was authorised in 6 European Member States: Belgium, France, Italy, Luxembourg and Portugal.
Slovenian: Veralipride je bil odobren v šestih evropskih državah: Belgiji, Franciji, Italiji, Luksemburgu in na Portugalskem.
English: The Rapporteur and Co-Rapporteur appointed were: Eric Abadie and Barbara van Zwieten-Boot, respectively.
Slovenian: Poročevalec in soporočevalka sta bila Eric Abadie in Barbara van Zwieten-Boot.
English: London, 1 October 2007 EMEA/CHMP/432352/2007
Slovenian: London, 1. oktobra 2007 EMEA/CHMP/432352/2007
English: The final opinion was converted into a Decision by the European Commission on 1 October 2007.
Slovenian: Končno mnenje je bilo spremenjeno v Odločbo Evropske komisije dne 1. oktobra 2007.
English: * Note: The information given in this document and Annexes reflects the CHMP Opinion dated 19 July 2007.
Slovenian: *Opomba: Informacije, podane v tem dokumentu in v Dodatkih odražajo mnenje CHMP z dne 19. julija 2007.
English: The list of product names concerned is given in Annex I.
Slovenian: Seznam zadevnih imen izdelkov je podan v Dodatku I.
English: The referral procedure started on 21 September 2006.
Slovenian: Napotitveni postopek se je začel 21. septembra 2006.
English: Written explanations were provided by the Marketing Authorisation Holder on 4 January 2007.
Slovenian: Pisna pojasnila je imetnik dovoljenja za promet z zdravilom predložil dne 4. januarja 2007.
English: Oral explanations were given on 20 June
Slovenian: Ustna pojasnila so bila podana dne 20. junija 2007.
English: On 19 July 2007, based on evaluation of the currently available data and the Rapporteurs' assessment reports, the CHMP considered that the benefit/risk profile of veralipride-containing medicinal products is negative and therefore adopted an opinion recommending the withdrawal of the Marketing Authorisation for all medicinal products containing veralipride.
Slovenian: Dne 19. julija 2007 je CHMP na podlagi trenutno razpoložljivih podatkov in poročevalčevih poročil o oceni menil, da je razmerje med koristmi in tveganji zdravil, ki vsebujejo veralipride negativno, in je zato izdal mnenje, s katerim priporoča umik dovoljenja za promet z vsemi zdravili, ki vsebujejo veralipride.
English: COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 31 REFERRAL FOR Agreal and associated names (see annex I) International Non-Proprietary Name (INN): Veralipride
Slovenian: ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 31 ZA Agreal in z njim povezana imena (glejte Dodatek I) Mednarodno nelastniško ime (INN): Veralipride
English: On 7 September 2006, following the withdrawal of veralipride from the Spanish market due to reports of serious side effects affecting the nervous system, the European Commission referred the matter to the EMEA under Article 31 of Directive 2001/83/EC.
Slovenian: Po umiku zdravila veralipride s španskega trga zaradi poročil o resnih neželenih stranskih učinkih, ki vplivajo na živčni sistem, je Evropska komisija dne 7. septembra 2006 napotila zadevo na agencijo EMEA v skladu s členom 31 Direktive 2001/83/ES.
English: Veralipride was approved since 1979 for the indication of treatment of vasomotor symptoms (hot flushes) associated with the menopause.
Slovenian: Veralipride je od leta 1979 odobren za zdravljenje vazomotornih simptomov (navali vročine), povezanih z menopavzo.
English: Until June 2005, veralipride was also marketed in Spain.
Slovenian: Do junija 2005 je bil na tržišču tudi v Španiji.
English: An extra drop should be given 30 to 120 minutes before the operation begins.
Slovenian: Dodatno kapljico je treba nanesti 30 do 120 minut pred začetkom operativnega posega.
English: If other eye medicines are also being used, there should be a gap of at least five minutes between using each medicine.
Slovenian: Če se uporabljajo tudi druga zdravila za oči, mora med uporabo posameznega zdravila preteči vsaj pet minut.
English: Treatment should begin one day before the cataract operation.
Slovenian: Z zdravljenjem je treba začeti en dan pred operacijo katarakte.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nevanac on 11 December 2007.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Nevanac, veljavno po vsej Evropski uniji, izdala 11. decembra 2007.
English: What measures are being taken to ensure the safe and effective use of Nevanac?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Nevanac?
English: Nevanac nepafenac
Slovenian: Nevanac nepafenak
English: The full EPAR for Nevanac can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Nevanac je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The main measure of effectiveness was either the proportion of patients in whom treatment had been successful (with no or few signs of inflammation in the eye), or the proportion of patients whose treatment had failed (with signs of moderate or severe inflammation in the eye).
Slovenian: Glavno merilo učinkovitosti je bil bodisi delež bolnikov, pri katerih je bilo zdravljenje uspešno (ki niso imeli več ali so imeli le malo znakov vnetja očesa), ali delež bolnikov, pri katerih zdravljenje ni bilo uspešno (ki so imeli znake zmernega ali hudega vnetja očesa).
English: What benefit has Nevanac shown during the studies?
Slovenian: Kakšne koristi je zdravilo Nevanac izkazalo med študijami?
English: These were measured two weeks after surgery.
Slovenian: Znake so merili dva tedna po operativnem posegu.
English: For more information about treatment with Nevanac, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Nevanac preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: This is a summary of the European public assessment report (EPAR) for Nevanac.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Nevanac.
English: Additionally, contact lens wear is not recommended during the postoperative period following cataract surgery.
Slovenian: Poleg tega nošnja kontaktnih leč ni priporočljiva v obdobju po operaciji katarakte.
English: Treatment is continued after the operation for 2 to 3 weeks when used to prevent pain and inflammation, or up to 60 days when used to reduce the risk of macular oedema.
Slovenian: Zdravljenje se po operativnem posegu nadaljuje dva do tri tedne, če se zdravilo uporablja za preprečevanje bolečine in vnetja, ali do 60 dni, če se uporablja za zmanjšanje tveganja makularnega edema.
English: The main measure of effectiveness was the number of patients who developed macular oedema within 90 days of surgery.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih se je v 90 dneh po operativnem posegu razvil makularni edem.
English: 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 Nevanac.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Nevanac, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The CHMP decided that Nevanac's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Nevanac večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: Other information about Nevanac
Slovenian: Druge informacije o zdravilu Nevanac
English: What is the risk associated with Nevanac?
Slovenian: Kakšna tveganja so povezana z zdravilom Nevanac?
English: The company also carried out studies to show that Nevanac 3 mg/ml given once a day was more effective than placebo and had the same effect in preventing and treating pain and inflammation as Nevanac 1 mg/ml given three times a day.
Slovenian: Družba je izvedla tudi študije, da bi pokazala, da je bilo zdravilo Nevanac 3 mg/ml dano enkrat na dan učinkovitejše od placeba in da je imelo enak učinek pri preprečevanju in zdravljenju bolečine in vnetja kot zdravilo Nevanac 1 mg/ml, dano trikrat na dan.
English: By reducing the production of prostaglandins in the eye, Nevanac can reduce complications caused by eye surgery, such as inflammation, pain and swelling.
Slovenian: Z zmanjšanjem tvorjenja prostaglandinov v očesu lahko zdravilo Nevanac zmanjša zaplete, ki jih povzroči operativni poseg na očeh, kot so vnetje, bolečina in otekanje.
English: When Nevanac was compared with placebo, around 70% of the patients using Nevanac had no signs of inflammation after two weeks, compared with 17% to 59% of those using placebo.
Slovenian: Ko so zdravilo Nevanac primerjali s placebom, okoli 70 % bolnikov, ki so uporabljali zdravilo Nevanac, po dveh tednih ni imelo znakov vnetja, v primerjavi s 17 % do 59 % tistih, ki so uporabljali placebo.
English: Why has Nevanac been approved?
Slovenian: Zakaj je bilo zdravilo Nevanac odobreno?
English: The first main study used Nevanac 1 mg/ml whereas the other 2 main studies used Nevanac 3 mg/ml.
Slovenian: V prvi glavni študiji so uporabili zdravilo Nevanac 1 mg/ml, v drugih dveh glavnih študijah pa zdravilo Nevanac 3 mg/ml.
English: Therefore, patients should be advised not to wear contact lenses during treatment with Nevanac.
Slovenian: Zato je treba bolnikom med prejemanjem zdravila Nevanac odsvetovati nošnjo kontaktnih leč.