FrancophonIA/ELRC3.0 huggingface dataset:
English: AUC: ↓ 27% (↓ 20 to ↓ 33) Cmax: ↓ 20% (↓ 15 to ↓ 24) Cmin: ↓ 35% (↓ 24 to ↓ 44)
Slovenian: AUC: ↓ 27 % (↓ 20 do ↓ 33) Cmax: ↓ 20 % (↓ 15 do ↓ 24) Cmin: ↓ 35 % (↓ 24 do ↓ 44)
English: AUC: ↓ 75% (↓ 59 to ↓ 84) Cmax: ↓ 64% (↓ 57 to ↓ 69) Cmin: ↓ 62% (↓ 44 to ↓ 75)
Slovenian: AUC: ↓ 75 % (↓ 59 do ↓ 84) Cmax: ↓ 64 % (↓ 57 do ↓ 69) Cmin: ↓ 62 % (↓ 44 do ↓ 75)
English: The median increase from baseline in CD4+ count at 48 weeks of therapy was 128 cells/mm3 and the median increase in CD4+ percentage was 5%.
Slovenian: V 48. tednu mediana povečanja od izhodišča za število celic CD4+ je bila 128 celic/mm3 in mediana povečanja odstotka celic CD4+ je bila 5 %.
English: Mean change from baseline-CD4 cell count Cells/mm3 (S.E.M.
Slovenian: celic/mm3 (S.N.P.
English: Lopinavir/ritonavir tablets/ efavirenz
Slovenian: lopinavir/ritonavir mehke kapsule ali peroralna raztopina/efavirenz lopinavir/ritonavir tablete/efavirenz
English: Triacetin 3
Slovenian: Preglednica 3.
English: The median increase from baseline in CD4+ count at 48 weeks of therapy was 238 cells/mm3 and the median increase in CD4+ percentage was 13%.
Slovenian: V 48. tednu mediana povečanja od izhodišča v številu celic CD4+ je bila 238 celic/mm3 in mediana povečanja odstotka celic CD4+ je bila 13 %.
English: AUC: ↓ 26% (↓ 15 to ↓ 36) Cmax: ↓ 20% (↓ 11 to ↓ 28) Cmin: ↓ 32% (↓ 15 to ↓ 46)
Slovenian: AUC: ↓ 26 % (↓ 15 do ↓ 36) Cmax: ↓ 20 % (↓ 11 do ↓ 28) Cmin: ↓ 32 % (↓ 15 do ↓ 46)
English: Rifampicin/efavirenz (600 mg once daily/600 mg once daily)
Slovenian: rifampicin/efavirenz (600 mg enkrat na dan/600 mg enkrat na dan)
English: Integrase strand transfer inhibitor Raltegravir/efavirenz (400 mg single dose/ -)
Slovenian: raltegravir/efavirenz (400 mg enkratni odmerek/ - )
English: Theoretically, efavirenz may therefore initially increase the exposure to CYP3A4 substrates and caution is warranted for CYP3A4 substrates with narrow therapeutic index (see section 4.3).
Slovenian: in je zato pri substratih CYP3A4 z ozkim terapevtskim oknom potrebna previdnost (glejte poglavje 4.3).
English: Recommendation concerning co-administration with efavirenz efavirenz for any of these medicinal products.
Slovenian: Priporočilo glede sočasne uporabe z efavirenzem odmerjanja.
English: PARTICULARS TO APPEAR ON THE OUTER CARTON COMPONENT OF MULTIPACK OF 90 (3 PACKS OF 30 x 1 FILM-COATED TABLETS)WITHOUT BLUE BOX
Slovenian: PODATKI NA ZUNANJI OVOJNINI DRUGIH PAKIRANJ SESTAVNI DEL ŠKATLE 90 (3 zloženke po 30x1 filmsko obloženih tablet) - brez »BLUE BOX«
English: Common Abnormal dreams, anxiety, depression, insomnia* Uncommon Affect lability, aggression, confusional state, euphoric mood, hallucination, mania,
Slovenian: občasni čustvena labilnost, nasilno vedenje, zmedenost, evforično razpoloženje,
English: Package leaflet: information for the user Efavirenz Teva 600 mg film-coated tablets efavirenz
Slovenian: NAVODILO ZA UPORABO Efavirenz Teva 600 mg filmsko obložene tablete efavirenz
English: ACID-REDUCING AGENTS Aluminium hydroxidemagnesium hydroxidesimethicone antacid/efavirenz (30 ml single dose/400 mg single dose)
Slovenian: ZDRAVILA ZA KISLINSKO POGOJENE BOLEZNI aluminijev hidroksidnimagnezijev hidroksidnisimetikonijev antacid/efavirenz (enkratni odmerek 30 ml /enkratni odmerek 400 mg)
English: N-monodesmethyl diltiazem: AUC: ↓ 37% (↓ 17 to ↓ 52) Cmax: ↓ 28% (↓ 7 to ↓ 44) Cmin: ↓ 37% (↓ 17 to ↓ 52)
Slovenian: AUC: ↓ 37 % (↓ 17 do ↓ 52) Cmax: ↓ 28 % (↓ 7 do ↓ 44) Cmin: ↓ 37 % (↓ 17 do ↓ 52)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR MULTIPACKS OF 90 (3 PACKS OF 30 x 1 FILM-COATED TABLETS) - WITH THE BLUE BOX
Slovenian: PODATKI NA ZUNANJI OVOJNINI DRUGIH PAKIRANJ ZUNANJA NALEPKA ŠKATLE 90 (3 zloženke po 30x1 filmsko obloženih tablet) - z »BLUE BOX«
English: Itraconazole/efavirenz (200 mg q12h/600 mg once daily)
Slovenian: Antimikotiki itrakonazol/efavirenz (200 mg q12h/600 mg enkrat na dan)
English: Efavirenz Teva can reduce the amount of statins in your blood.
Slovenian: Zdravilo Efavirenz Teva lahko zmanjša količino statinov v krvi.
English: Biliary hyperplasia was observed in cynomolgus monkeys given efavirenz for ≥ 1 year at a dose resulting in mean AUC values approximately 2-fold greater than those in humans given the recommended dose.
Slovenian: Pri opicah Cynomolgus, ki so jim ≥ 1 leto dajali efavirenz v odmerkih, s katerimi so dosegli približno
English: AUC: ↓ 18% (↓ 8 to ↓ 27) Cmax: ↓ 14% (↓ 3 to ↓ 24) Cmin: ↓ 25% (↓ 14 to ↓ 34)% Efavirenz:
Slovenian: AUC: ↓ 18 % (↓ 8 do ↓ 27) Cmax: ↓ 14 % (↓ 3 do ↓ 24) Cmin: ↓ 25 % (↓ 14 do ↓ 34)%
English: Fosamprenavir/ritonavir/ efavirenz (700 mg twice daily/100 mg twice daily/600 mg once daily)
Slovenian: fosamprenavir/ritonavir/ efavirenz (700 mg dvakrat na dan/100 mg dvakrat na dan/600 mg enkrat na dan)
English: Efavirenz must be discontinued in patients developing severe rash associated with blistering, desquamation, mucosal involvement or fever.
Slovenian: Jemanje efavirenza je treba prekiniti pri bolnikih, pri katerih se razvije hud izpuščaj, ki ga spremljajo mehurji,
English: In 35 patients receiving efavirenz 600 mg once daily, steady-state Cmax was 12.9 ± 3.7 microM (29%) [mean ± S.D. (% C.V.)], steady-state Cmin was 5.6 ± 3.2 microM (57%), and AUC was 184 ± 73 microM·h (40%).
Slovenian: )], Cmin 5,6 ± 3,2 µM (57 %) in AUC 184 ± 73 µM·h (40 %).
English: ↓elbasvir ↓grazoprevir
Slovenian: ↓elbasvir ↓grazoprevir ↔efavirenz
English: Atovaquone and proguanil hydrochloride/efavirenz (250/100 mg single dose/600 mg once daily)
Slovenian: atovakon in progvanilijev klorid/efavirenz (250/100 mg enkratni odmerek/600 mg enkrat na dan)
English: Cmin: ↓ 44% Efavirenz:
Slovenian: Cmin: ↓ 91 % (↓ 88 do ↓ 92) efavirenz:
English: Film-coating
Slovenian: filmsko obložena tableta
English: Implant: Etonogestrel/efavirenz Decreased exposure of etonogestrel may be expected (CYP3A4 induction).
Slovenian: Lahko pričakujemo zmanjšano izpostavitev etonogestrelu (indukcija CYP3A4).
English: The dose of lopinavir/ritonavir tablets should be increased to 500/125 mg twice daily when co-administered with efavirenz 600 mg once daily.
Slovenian: Pri jemanju z efavirenzom 600 mg enkrat na dan je treba odmerek lopinavir/ritonavir tablet povečati na 500/125 mg dvakrat na dan. Glejte tudi informacije za ritonavir v nadaljevanju.
English: Skin rash was considered treatment-related in 18% of patients treated with efavirenz.
Slovenian: Pri 18 % bolnikov, zdravljenih z efavirenzem, so menili, da je pojav izpuščaja povezan z zdravljenjem.
English: (CYP3A induction by efavirenz)
Slovenian: (indukcija CYP3A z efavirenzem)
English: Simvastatin/efavirenz (40 mg once daily/600 mg once daily)
Slovenian: simvastatin/efavirenz (40 mg enkrat na dan/600 mg enkrat na dan)
English: problems with coordination or balance - stomach pain, diarrhoea, feeling sick (nausea), vomiting - itching - tiredness - feeling anxious, feeling depressed
Slovenian: - bolečine v trebuhu, driska, slabost (siljenje na bruhanje), bruhanje
English: Ritonavir/efavirenz (500 mg twice daily/600 mg once daily)
Slovenian: ritonavir/efavirenz (500 mg dvakrat na dan/600 mg enkrat na dan)
English: Valproic acid/efavirenz (250 mg twice daily/600 mg once daily)
Slovenian: valprojska kislina/efavirenz (250 mg dvakrat na dan/600 mg enkrat na dan)
English: In vitro efavirenz is also an inhibitor of CYP3A4.
Slovenian: Efavirenz je tudi inhibitor CYP3A4 in vitro, zato lahko teoretično v osnovi poveča izpostavljenost substratom CYP3A4
English: Fluconazole/efavirenz (200 mg once daily/400 mg once daily)
Slovenian: flukonazol/efavirenz (200 mg enkrat na dan/400 mg enkrat na dan)
English: Indinavir/ritonavir/efavirenz (800 mg twice daily/100 mg twice daily/600 mg once daily)
Slovenian: indinavir/ritonavir/efavirenz (800 mg dvakrat na dan/100 mg dvakrat na dan/600 mg enkrat na dan)
English: Atovaquone:
Slovenian: atovakon:
English: Medicines used to treat depression such as imipramine, amitriptyline or clomipramine Antibiotics, including the following types: macrolides, fluoroquinolones or imidazole.
Slovenian: - zdravila za zdravljenje depresije kot so imipramin, amitriptilin ali klomipramin.
English: Effects on drug levels Mean percent change in AUC, Cmax, Cmin with confidence intervals if availablea
Slovenian: Srednja sprememba AUC, Cmax,
English: Voriconazole/efavirenz (400 mg twice daily/300 mg once daily)
Slovenian: vorikonazol/efavirenz (400 mg dvakrat na dan/300 mg enkrat na dan)
English: If efavirenz is co-administered with rifampicin to patients weighing 50 kg or more, an increase in the dose of efavirenz to 800 mg/day may be considered (see section 4.5).
Slovenian: lahko po potrebi povečate odmerek zdravila Efavirenz na 800 mg/dan (glejte poglavje 4.5).
English: Stevens-Johnson syndrome) - yellow skin or eyes, itching, or pain in the abdomen (stomach) caused by inflammation of the liver - breast enlargement in males - angry behaviour, mood being affected, seeing or hearing things that are not really there
Slovenian: - porumenelost kože ali oči, srbenje ali bolečina v trebuhu (želodcu) zaradi vnetja jeter - povečanje prsi pri moških
English: Symptoms including, but not limited to dizziness, insomnia, somnolence, impaired concentration and abnormal dreaming are frequently reported adverse reactions in patients receiving efavirenz 600 mg daily in clinical studies (see section 4.8).
Slovenian: V kliničnih študijah pri bolnikih, ki so jemali 600 mg efavirenza na dan, so pogosto poročali o neželenih učinkih, ki so vključevali tudi naslednje simptome: omotico, nespečnost, zaspanost, motnje koncentracije in nenormalne sanje (glejte poglavje 4.8).
English: b C.I., confidence interval.
Slovenian: Cmin z intervali zaupanja, če so na voljo a
English: There have also been post-marketing reports of death by suicide, delusions, psychosis-like behaviour and catatonia.
Slovenian: V obdobju trženja zdravila so poročali tudi o smrti zaradi samomora, blodnjavih motnjah,
English: (induction of metabolism)
Slovenian: (indukcija presnove)
English: AUC: ↑ 11% (↑ 5 to ↑ 18) Cmax: ↑ 16% (↑ 6 to ↑ 26) Cmin: ↑ 13% (↑ 1 to ↑ 26) (CYP3A4 induction) The increase in efavirenz pharmacokinetic parameters is not considered clinically significant.
Slovenian: AUC: ↑ 11 % (↑ 5 do ↑ 18) Cmax: ↑ 16 % (↑ 6 do ↑ 26) Cmin: ↑ 13 % (↑ 1 do ↑ 26)
English: Voriconazole: AUC: ↓ 77% Cmax: ↓ 61%
Slovenian: AUC: ↓ 77 % Cmax: ↓ 61 %
English: < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); or very rare (< 1/10,000).
Slovenian: ali zelo redki (< 1/10.000).
English: Plasma trough concentrations of boceprevir were decreased when
Slovenian: Najnižje plazemske koncentracije boceprevirja pred naslednjim odmerkom so se pri sočasni uporabi z efavirenzem zmanjšale.
English: - Efavirenz Teva must be taken every day.
Slovenian: - Zdravilo Efavirenz Teva se vzame skozi usta.
English: Reproductive system and breast disorders Uncommon Gynaecomastia
Slovenian: redki fotoalergijski dermatitis† Motnje reprodukcije in dojk občasni ginekomastija
English: Lopinavir concentrations: similar to lopinavir/ritonavir 400/100 mg twice daily without efavirenz
Slovenian: Koncentracije lopinavirja: podobne kot pri lopinavirju/ritonavirju 400/100 mg dvakrat na dan brez efavirenza nelfinavir/efavirenz (750 mg q8h/600 mg enkrat na dan)
English: Pravastatin/efavirenz (40 mg once daily/600 mg once daily)
Slovenian: pravastatin/efavirenz (40 mg enkrat na dan/600 mg enkrat na dan)
English: EXPIRY DATE
Slovenian: tremor†
English: Efavirenz exposure may be increased when given with medicinal products (for example, ritonavir) or food (for example, grapefruit juice), which inhibit CYP3A4 or CYP2B6 activity.
Slovenian: Izpostavitev efavirenzu se lahko poveča pri uporabi skupaj z zdravili (npr. z ritonavirjem) ali s hrano
English: Other interactions: efavirenz does not bind to cannabinoid receptors.
Slovenian: a 90-odstotni intervali zaupanja, razen če ni drugače navedeno b 95-odstotni intervali zaupanja Druge interakcije: efavirenz se ne veže na kanabinoidne receptorje.
English: NRTIs
Slovenian: CART.
English: AUC: ↓ 52% (↓ 33 to ↓ 66) Cmax: ↓ 45% (↓ 25 to ↓ 59) (CYP3A4 induction)
Slovenian: AUC: ↓ 52 % (↓ 33 do ↓ 66) Cmax: ↓ 45 % (↓ 25 do ↓ 59)
English: Nervous system symptoms usually begin soon after therapy onset and generally resolve after the first 24 weeks.
Slovenian: Simptomi živčnega sistema se običajno pojavijo kmalu po začetku zdravljenja in običajno minejo po prvih 2 - 4 tednih.
English: Medicinal product by therapeutic areas (dose)
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
English: Voriconazole/efavirenz (200 mg twice daily/400 mg once daily)
Slovenian: vorikonazol/efavirenz (200 mg dvakrat na dan/400 mg enkrat na dan)
English: CD4+ count at 48 weeks was 215 cells/mm3 and the median increase in CD4+ percentage was 6%.
Slovenian: V 48. tednu mediana povečanja od izhodišča v številu celic CD4+ je znašala 215 celic/mm3 in mediana povečanja odstotka celic CD4+ je znašala
English: efavirenz-associated adverse events should be considered, due to possible pharmacodynamic interaction.
Slovenian: morebitnih farmakodinamičnih interakcij.
English: Concomitant administration of velpatasvir/sofosbuvir/ voxilaprevir with efavirenz is not recommended, as it may decrease concentrations of velpatasvir and voxilaprevir.
Slovenian: voksilaprevira ni priporočljiva, saj lahko zmanjša koncentracijo velpatasvira in voksilaprevira.
English: EU/1/11/742/004 (bundle multi-pack - blister PVC/PVDC/alu) EU/1/11/742/009 (bundle multi-pack - blister alu/alu)
Slovenian: EU/1/11/742/004 (omot z 90 filmsko obloženimi tabletami - pretisni omot PVC/PVDC/alu) EU/1/11/742/009 (omot z 90 filmsko obloženimi tabletami - pretisni omot alu/alu)
English: AUC: ↑ 7% (↑ 1 to ↑ 14) Cmax: ↑ 16% (↑ 2 to ↑ 32) These changes are not considered clinically significant.
Slovenian: AUC: ↑ 7 % (↑ 1 do ↑ 14) Cmax: ↑ 16 % (↑ 2 do ↑ 32)
English: EU/1/11/742/005 (carton multi-pack - blister PVC/PVDC/alu) EU/1/11/742/010 (carton multi-pack - blister alu/alu)
Slovenian: EU/1/11/742/005 (omot z 90 filmsko obloženimi tabletami - pretisni omot PVC/PVDC/alu) EU/1/11/742/010 (omot z 90 filmsko obloženimi tabletami - pretisni omot alu/alu)
English: AUC: ↓ 18% (↓ 10 to ↓ 26) Cmax: ↓ 24% (↓ 15 to ↓ 32)
Slovenian: AUC: ↓ 18 % (↓ 10 do ↓ 26) Cmax: ↓ 24 % (↓ 15 do ↓ 32) Cmin: ↓ 10 % (↑ 1 do ↓ 19)%
English: Azithromycin/efavirenz (600 mg single dose/400 mg once daily)
Slovenian: Antibiotiki azitromicin/efavirenz (enkratni odmerek 600 mg/ 400 mg enkrat na dan)
English: Name and address of the manufacturer responsible for batch release PLIVA Hrvatska d.o.o.
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serije
English: Efavirenz Teva may reduce the amount of posaconazole in your blood.
Slovenian: Zdravilo Efavirenz Teva lahko zmanjša količino posakonazola v krvi.
English: Antimycobacterials Rifabutin/efavirenz (300 mg once daily/600 mg once daily)
Slovenian: Zdravila za zdravljenje okužb z mikobakterijami rifabutin/efavirenz (300 mg enkrat na dan/600 mg enkrat na dan)
English: When efavirenz is co-administered with voriconazole, the voriconazole maintenance dose must be increased to 400 mg twice daily and the efavirenz dose must be reduced by 50%, i.e. to 300 mg once daily.
Slovenian: 400 mg dvakrat na dan, odmerek efavirenza pa zmanjšati za 50 %, to je na 300 mg enkrat na dan.
English: 30 x 1 film-coated tablet in white opaque PVC/PVdC-aluminium or aluminium-aluminium perforated unit-dose blisters.
Slovenian: Perforirani, bel, prozoren PVC/PVdC-aluminij ali aluminij-aluminij, enoodmerni pretisni omot, ki vsebuje 30x1 filmsko obloženo tableto.
English: Atazanavir/ritonavir/efavirenz (400 mg once daily/100 mg once daily/600 mg once daily, all administered with food)
Slovenian: ZDRAVILA ZA ZDRAVLJENJE INFEKCIJ Zdravila za zdravljenje okužbe s HIV Zaviralci proteaze (ZP) atazanavir/ritonavir/efavirenz (400 mg enkrat na dan/100 mg enkrat na dan/600 mg enkrat na dan, vse s hrano)
English: You should consult your doctor if you have a rash, since some rashes may be serious; however, most cases of rash disappear without any change to your treatment with Efavirenz Teva.
Slovenian: Vendar pa v večini primerov izpuščaj izgine, ne da bi spremenili zdravljenje z zdravilom Efavirenz Teva.
English: Uncommon Tinnitus†, vertigo Vascular disorders
Slovenian: Ušesne bolezni, vključno z motnjami labirinta občasni tinitus†, vertigo
English: Famotidine/efavirenz (40 mg single dose/400 mg single dose)
Slovenian: famotidin/efavirenz (enkratni odmerek 40 mg /enkratni odmerek 400 mg) ANKSIOLITIKI lorazepam/efavirenz (enkratni odmerek 2 mg/600 mg enkrat na dan)
English: Concomitant use of posaconazole and efavirenz should be avoided unless the benefit to the patient
Slovenian: Sočasni uporabi posakonazola in efavirenza se je treba izogibati,
English: HIV antivirals Protease inhibitors (PI)
Slovenian: Zaviralec integraze (prepreči vgradnjo virusne DNA v celično DNA)
English: In Europe, nimesulide is nationally authorised in 16 Member States (Austria, Belgium, Bulgaria, Czech Republic, Cyprus, France, Greece, Hungary, Italy, Latvia, Lithuania, Malta, Portugal, Romania, Slovakia and Slovenia).
Slovenian: V Evropi so nimesulid odobrili pristojni nacionalni organi v 17 državah članicah (Avstriji, Belgiji, Bolgariji, Češki republiki, Cipru, Franciji, Grčiji, Madžarski, Italiji, Latviji, Litvi, Malti, Poljska, Portugalski, Romuniji, Slovaški in Sloveniji).
English: The harmonised product information were implemented in the Member States end of 2004-beginning of 2005.
Slovenian: Usklajene informacije o zdravilu so bile v državah članicah uveljavljene v obdobju od konca leta 2004 do začetka leta 2005.
English: Nimesulide-containing medicinal products are currently marketed in more than 50 countries worldwide, particularly in Europe and South America.
Slovenian: Zdravila, ki vsebujejo nimesulid, se trenutno tržijo v več kot 50 državah po svetu, zlasti pa v Evropi in Južni Ameriki.
English: Conditions of the Marketing Authorisations are identified in Annex IV of this Opinion.
Slovenian: Pogoji dovoljenja za promet z zdravilom so opredeljeni v Dodatku IV te odločbe.
English: Having considered all of the available evidence, the CHMP concluded that the data did not support a suspension of all marketing authorisations in Europe.
Slovenian: Ob upoštevanju vseh razpoložljivih dokazov je CHMP zaključil, da podatki ne podpirajo umika vseh dovoljenj za promet v Evropi.
English: The assessment of these consequences were supported by a simulation of the possible impact of nimesulide withdrawal in Italy.
Slovenian: Oceno teh posledic so podprli s simulacijo potencialnih učinkov umika nimesulida s trga v Italiji.
English: - The maximum duration of a treatment course with nimesulide is 15 days.
Slovenian: - Najdaljše trajanje zdravljenja z nimesulidom je 15 dni.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF NIMESULIDE CONTAINING MEDICINAL PRODUCTS (SYSTEMIC FORMULATIONS) (see Annex I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVIL (ZDRAVIL ZA SISTEMSKO UPORABO), KI VSEBUJEJO NIMESULID (glejte Dodatek I)
English: Nimesulide is a non-steroidal anti-inflammatory drug (NSAID), available only on prescription and authorised in Europe since 1985.
Slovenian: Nimesulid je nesteroidno protivnetno zdravilo (NSAID), ki se dobi samo na recept in je v Evropi dovoljeno za uporabo od leta 1985.
English: Having reviewed all available data on hepatotoxicity, the CHMP concluded the following.
Slovenian: Po pregledu vseh razpoložljivih podatkov o jetrni toksičnosti je CHMP zaključil naslednje:
English: The CHMP agreed, that the risk minimisation measures adopted at the end of the first referral have been able to contain the incidence of the most serious liver injuries.
Slovenian: CHMP se je strinjal, da so ukrepi za zmanjševanje tveganj, sprejeti ob zaključku prvega napotitvenega postopka, uspeli zajeziti pojavnost večine resnih jetrnih poškodb.
English: The use of nimesulide in strict accordance with the Product Information recommendations has been shown to be equally effective in reducing hepatic toxicity.
Slovenian: Pokazalo se je tudi, da je uporaba nimesulida ob strogem upoštevanju priporočil v informacijah o zdravilu enako učinkovit način za zmanjšanje jetrne toksičnosti.
English: The CHMP reviewed the data presented, including answers provided by the Marketing Authorisations Holders (MAHs), pharmacovigilance data provided by the Member States, data provided by the EMEA and literature review.
Slovenian: CHMP je pregledal predstavljene podatke, vključno z odgovori, ki so jih predložili imetniki dovoljenja za promet z zdravilom, podatki o farmakovigilanci, ki so jih predložile države članice, ter podatki, ki jih je zagotovila EMEA, in podatki, zbranimi s pregledom objavljene literature.
English: - The limitation of treatment with nimesulide not longer than 15 days may limit the risk of acute liver injury.
Slovenian: - Omejitev trajanja zdravljenja z nimesulidom na največ 15 dni utegne omejiti tveganje za akutno poškodbo jeter.
English: This simulation showed a notable reduction of hospitalisation due to liver injuries whilst hospitalisation due to gastroinstestinal toxicity might increase.
Slovenian: Simulacija je pokazala opazno zmanjšanje obsega hospitalizacije zaradi poškodb jeter, medtem ko se je izkazalo, da utegne obseg hospitalizacije zaradi gastrointestinalne toksičnosti narasti.
English: Finally, according to the data submitted by the Marketing Authorisation Holder the majority of hepatic disorders (56%), occurred after two weeks of treatment, therefore a treatment period of not longer than 15 days may limit the risk of acute liver injury.
Slovenian: Glede na podatke, ki jih je predložil imetnik dovoljenja za promet z zdravilom, je do večine jetrnih obolenj (56 %) prišlo po dveh tednih zdravljenja, zato lahko s skrajšanjem obdobja zdravljenja na največ 15 dni omejimo tveganje za akutno poškodbo jeter.
English: The review concluded that a small increase in the absolute risk for hepatotoxic reactions associated with nimesulide cannot be excluded although the overall risk benefit/balance remains positive.
Slovenian: Pregled je bil zaključen z ugotovitvijo, da ni mogoče izključiti majhnega porasta absolutnega tveganja za hepatotoksične reakcije, povezane z nimesulidom, vendar pa skupno razmerje med tveganji in koristmi še dalje ostaja pozitivno.
English: The additional Product Information restrictions together with a limitation of duration of treatment and withdrawal of the pack sizes above 30 units aim at further minimising such risk, together with the conditions (see Annex IV) and the effort of national competent authorities in education and information activities on both prescribers and patients.
Slovenian: Cilj dodatnih omejitev v informacijah o zdravilu skupaj z omejitvijo trajanja zdravljenja in umikom iz prometa vseh pakiranj, ki vsebujejo več kot 30 enot, je, da poleg pogojev (glejte Dodatek IV) in prizadevanj nacionalnih pristojnih organov za izobraževanje in informiranje zdravnikov in bolnikov, še dodatno zmanjšajo omenjeno tveganje.
English: This referral concluded, with divergent positions submitted by Finland, Spain and Ireland, that the benefit/risk profile of nimesulide for systemic use remained positive, subject to revision of the product information, including a restriction of the maximum oral dose to 100 mg twice daily.
Slovenian: Napotitveni postopek se je vpričo razhajajočih se stališč, ki so jih predložile Finska, Španija in Irska, končal z ugotovitvijo, da ostaja razmerje med koristmi in tveganji pri sistemski uporabi nimesulida pozitivno, vendar pa je treba informacije o zdravilu revidirati tako, da bodo vključevale omejitev največjega peroralnega odmerka na 100 mg dvakrat dnevno.
English: - Nimesulide showed a higher frequency of severe adverse hepatic reactions but the overall safety profile of nimesulide is not modified.
Slovenian: - Nimesulid je pokazal višjo pogostost hudih neželenih jetrnih reakcij, toda celokupni varnostni profil nimesulida ostaja nespremenjen.