FrancophonIA/ELRC3.0 huggingface dataset:
English: In the Einstein PE study (see Table 7) rivaroxaban was demonstrated to be non-inferior to enoxaparin/VKA for the primary efficacy outcome (p=0.0026 (test for non-inferiority); HR: 1.123 (0.749 - 1.684)).
Slovenian: V kliničnem preskušanju Einstein PE (glejte preglednico 7) je bilo prikazano, da je rivaroksaban neinferioren v primerjavi z zdravljenjem z enoksaparinom/antagonisti vitamina K za primarni izid učinkovitosti (p = 0.0026 (test za neinferiornost); razmerje tveganja: 1,123 (0,749 - 1,684)).
English: When Neoplastin PT was used, baseline PT was about 13 s and the slope was around 3 to 4 s/(100 mcgl).
Slovenian: Kadar je bil uporabljen Neoplastin, je bil izhodiščni PČ približno 13 sekund in naklon krivulje približno 3 do
English: Xarelto 20 mg film-coated tablets rivaroxaban
Slovenian: IME ZDRAVILA Xarelto 20 mg filmsko obložene tablete rivaroksaban
English: Xarelto 15 mg film-coated tablets rivaroxaban
Slovenian: IME ZDRAVILA Xarelto 15 mg filmsko obložene tablete rivaroksaban
English: EU/1/08/472/026 28 film-coated tablets
Slovenian: EU/1/08/472/026 28 filmsko obloženih tablet
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora epistaksa, hemoptiza
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 10 TABLETS FOR 2.5 MG
Slovenian: PRETISNI OMOT Z 10 TABLETAMI PO 2,5 MG
English: While patients are on both Xarelto and VKA the INR should not be tested earlier than 24 hours after the previous dose but prior to the next dose of
Slovenian: Medtem ko bolniki prejemajo hkrati zdravilo Xarelto in antagonist vitamina K, se vrednosti INR ne sme določiti prej kot
English: In the Einstein PE study (see Table 6) rivaroxaban was demonstrated to be non-inferior to enoxaparin/VKA for the primary efficacy outcome (p=0.0026 (test for non-inferiority); HR: 1.123 (0.749 - 1.684)).
Slovenian: V kliničnem preskušanju Einstein PE (glejte preglednico 6) je bilo prikazano, da je rivaroksaban neinferioren v primerjavi z zdravljenjem z enoksaparinom/antagonisti vitamina K za primarni izid učinkovitosti (p = 0.0026 (test za neinferiornost); razmerje tveganja: 1,123 (0,749 - 1,684)).
English: EU/1/08/472/047 14 film-coated tablets
Slovenian: EU/1/08/472/047 14 filmsko obloženih tablet
English: EU/1/08/472/028 60 film-coated tablets
Slovenian: EU/1/08/472/028 60 filmsko obloženih tablet
English: blood creatinine increased, blood urea increased)
Slovenian: okvara ledvic (tudi povečane vrednosti kreatinina v krvi,
English: Continuous adequate anticoagulation should be ensured during any transition to an alternate anticoagulant.
Slovenian: Obstaja možnost za neustrezno antikoagulacijsko zaščito pri zamenjavi zdravila Xarelto z antagonisti vitamina K. Pri zamenjavi z drugim antikoagulacijskim zdravilom je treba zagotoviti stalno ustrezno antikoagulacijo.
English: EU/1/08/472/029 98 film-coated tablets
Slovenian: EU/1/08/472/029 98 filmsko obloženih tablet
English: - For the treatment of DVT, treatment of PE and prevention of recurrent DVT and PE: patients should be treated with 15 mg twice daily for the first 3 weeks.
Slovenian: - Za zdravljenje GVT, zdravljenje PE ter preprečevanje ponovne GVT in PE: bolniki morajo prve
English: EU/1/08/472/012 28 film-coated tablets
Slovenian: EU/1/08/472/012 28 filmsko obloženih tablet
English: Concomitant treatment of CAD/PAD with ASA in patients with previous haemorrhagic or lacunar stroke, or any stroke within a month (see section 4.4).
Slovenian: Sočasno zdravljenje KB/PAB z acetilsalicilno kislino pri bolnikih, ki so predhodno doživeli hemoragično ali lakunarno možgansko kap ali katero koli drugo možgansko kap v zadnjem mesecu
English: - Keep this leaflet.
Slovenian: ♦ To kartico imejte vedno pri sebi.
English: Dosing recommendations before and after invasive procedures and surgical intervention If an invasive procedure or surgical intervention is required, Xarelto 20 mg should be stopped at least 24 hours before the intervention, if possible and based on the clinical judgement of the physician.
Slovenian: Priporočila za odmerjanje pred invazivnimi postopki in kirurškimi posegi in po njih Če je potreben invazivni postopek ali kirurški poseg, je treba, če je mogoče, in glede na klinično presojo zdravnika, zdravljenje z zdravilom Xarelto 20 mg prenehati vsaj 24 ur pred posegom.
English: 95% CI: (0.72, 0.97) P-value=0.020*
Slovenian: 0,84 (0,72; 0,97) p = 0,020*
English: Xarelto.
Slovenian: tiklopidin.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 10 TABLETS FOR 10 MG
Slovenian: PRETISNI OMOT ZA 10 TABLET PO 10 MG
English: Each 20 mg film-coated tablet contains 20 mg rivaroxaban.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 20 mg rivaroksabana.
English: They come in blisters in cartons of 10, 14, 28 or 98 film-coated tablets or in unit dose blisters in cartons of 10 x 1 or 100 x 1 or in multipacks comprising 10 cartons, each containing 10 x 1 film-coated tablets or in bottles of 100 film-coated tablets.
Slovenian: v škatlah po 10, 14, 28 ali 98 filmsko obloženih tablet v pretisnih omotih ali v škatlah po 10 x 1 ali 100 x 1 filmsko obložena tableta v perforiranih pretisnih omotih za enkratni odmerek ali v večkratnem pakiranju po 10 enot; ena enota vsebuje 10 x 1 filmsko obloženo tableto ali v plastenkah po 100 filmsko obloženih tablet.
English: EU/1/08/472/014 98 film-coated tablets
Slovenian: EU/1/08/472/014 98 filmsko obloženih tablet
English: Pruritus (incl.
Slovenian: HIV (npr. ritonavir).
English: EU/1/08/472/019 98 film-coated tablets
Slovenian: EU/1/08/472/019 98 filmsko obloženih tablet
English: The treatment duration was for an additional 6 or 12 months in patients who had completed 6 to 12 months of treatment for venous thromboembolism depending on the clinical judgment of the investigator.
Slovenian: V kliničnem preskušanju Einstein Extension so preučevali 1.197 bolnikov z GVT ali PE pri preprečevanju ponovne GVT in PE. Zdravljenje je trajalo dodatnih 6 ali 12 mesecev pri bolnikih, ki so predhodno zaključili 6 ali 12 mesecev zdravljenja zaradi venske trombembolije odvisno od klinične presoje raziskovalca.
English: Symptomatic
Slovenian: ODMEREK
English: They come in blisters in cartons of 10, 14, 28, 42 or 98 film-coated tablets or in unit dose blisters in cartons of 10 x 1 or 100 x 1 or in multipacks comprising 10 cartons, each containing 10 x 1 film-coated tablets or in bottles of 100 film-coated tablets.
Slovenian: v škatlah po 10, 14, 28, 42 ali 98 filmsko obloženih tablet v pretisnih omotih ali v škatlah po 10 x 1 ali 100 x 1 filmsko obložena tableta v perforiranih pretisnih omotih za enkratni odmerek ali v plastenkah po 100 filmsko obloženih tablet.
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema anemija (tudi ustrezni laboratorijski parametri)
English: Major bleeding events a) Rivaroxaban 15 mg twice daily for 3 weeks followed by 20 mg once daily b) Enoxaparin for at least 5 days, overlapped with and followed by VKA * p < 0.0026 (non-inferiority to a prespecified HR of 2.0); HR: 1.123 (0.749 - 1.684)
Slovenian: ni mogoče izključiti Velike ali klinično pomembne majhne krvavitve Velike krvavitve a) rivaroksaban v odmerku 15 mg dvakrat na dan 3 tedne, nato pa odmerek po 20 mg enkrat na dan b) enoksaparin vsaj 5 dni, sočasno zdravljenje z AVK in enoksaparinom in nadaljevanje zdravljenja z AVK * p < 0,0026 (neinferiornost glede na predhodno opredeljeno razmerje tveganja 2,0); razmerje tveganja: 1,123 (0,749 - 1,684)
English: Dosing recommendations before and after invasive procedures and surgical intervention If an invasive procedure or surgical intervention is required, Xarelto 15 mg should be stopped at least 24 hours before the intervention, if possible and based on the clinical judgement of the physician.
Slovenian: Priporočila za odmerjanje pred invazivnimi postopki in kirurškimi posegi in po njih Če je potreben invazivni postopek ali kirurški poseg, je treba, če je mogoče, in glede na klinično presojo zdravnika, zdravljenje z zdravilom Xarelto 15 mg prenehati vsaj 24 ur pred posegom.
English: - Fatal bleeding event p = 0.32164
Slovenian: p = 0,32164
English: Symptomatic recurrent PE 23
Slovenian: Simptomatska ponovna VTE* Simptomatska ponovna PE 23 Simptomatska ponovna GVT 18 Simptomatska PE in GVT 0
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) FOR 2.5 MG
Slovenian: ŠKATLA ZA VEČKRATNO PAKIRANJE ZA TABLETE PO 2,5 MG (S PODATKI ZA 'BLUE BOX')
English: Longer duration of therapy should be considered in patients with provoked DVT or PE not related to major transient risk factors, unprovoked DVT or PE, or a history of recurrent DVT or PE.
Slovenian: V podskupini bolnikov se je pomembno podaljšal čas krvavitve; sprememba ni bila povezana z agregacijo trombocitov, niti z vrednostjo P-selektina ali receptorja GPIIb/IIIa.
English: The physician educational pack should contain:
Slovenian: Izobraževalno gradivo za zdravnike mora vsebovati: • povzetek glavnih značilnosti zdravila,
English: This was followed by 20 mg rivaroxaban once daily.
Slovenian: Klinično pomembne majhne krvavitve a) rivaroksaban 20 mg enkrat na dan
English: How to store Xarelto
Slovenian: Shranjevanje zdravila Xarelto
English: conjunctival haemorrhage)
Slovenian: povečane vrednosti sečnine v krvi)
English: Clopidogrel (300 mg loading dose followed by 75 mg maintenance dose) did not show a pharmacokinetic interaction with rivaroxaban (15 mg) but a relevant increase in bleeding time was observed in a subset of patients which was not correlated to platelet aggregation, P-selectin or GPIIb/IIIa receptor levels.
Slovenian: Med klopidogrelom (300-mg začetni odmerek in nato 75-mg vzdrževalni odmerek) in rivaroksabanom (15 mg) ni bilo farmakokinetičnih interakcij.
English: Hypotension requiring treatment with intravenous inotropic agents
Slovenian: Hipotenzija, ki jo je bilo treba zdraviti z intravenskimi inotropnimi učinkovinami Kirurški poseg zaradi obstoječe krvavitve
English: Fatal PE/death where PE cannot be ruled out Symptomatic recurrent VTE, MI, stroke, or nonCNS systemic embolism
Slovenian: Simptomatska ponovna GVT 14 Simptomatska PE in GVT 1 Smrtna PE/smrt, pri kateri PE ni mogoče izključiti
English: Prevention of stroke and systemic embolism
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
English: PP/Aluminium foil blisters in cartons of 10, 14, 28, 42 or 98 film-coated tablets or perforated unit dose blisters in cartons of 10 x 1, or 100 x 1 or in multipacks containing 100 (10 packs of 10 x 1) filmcoated tablets.
Slovenian: Škatla po 10, 14, 28, 42 ali 98 filmsko obloženih tablet v pretisnih omotih iz PP/aluminija ali škatla po 10 x 1 ali 100 x 1 filmsko obložena tableta v perforiranih pretisnih omotih za enkratni odmerek ali v večkratnem pakiranju po 100 filmsko obloženih tablet (10 enot po 10 x 1 filmsko obložena tableta).
English: Light yellow, round biconvex tablets (6 mm diameter, 9 mm radius of curvature) marked with the BAYER-cross on one side and "2.5" and a triangle on the other side.
Slovenian: FARMACEVTSKA OBLIKA filmsko obložena tableta (tableta) svetlo rumene, okrogle bikonveksne tablete (6 mm premera, 9 mm polmer ukrivljenosti), na eni strani označene z oznako BAYER (križ) in na drugi strani s številko »2.5« in trikotnikom
English: - if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6) - if you are bleeding excessively - if you have a disease or condition in an organ of the body that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding in the brain, recent surgery of the brain or eyes) - if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when changing anticoagulant treatment or while getting heparin through a venous or arterial line to keep it open.
Slovenian: Bodite posebno pozorni pri uporabi zdravila Xarelto - če pri vas obstaja večje tveganje za krvavitve, kar bi lahko bilo v primerih, kot so: huda bolezen ledvic, saj lahko delovanje ledvic vpliva na količino zdravila, ki učinkuje v vašem telesu če jemljete druga zdravila za preprečevanje nastanka krvnih strdkov (npr. varfarin, dabigatran eteksilat, apiksaban ali heparin), če ste zamenjali antikoagulacijsko zdravljenje ali ko dobivate heparin skozi venski ali arterijski kateter za vzdrževanje prehodnosti katetra (glejte poglavje »Druga zdravila in zdravilo Xarelto«)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 14 TABLETS FOR 20 MG
Slovenian: PRETISNI OMOT S 14 TABLETAMI PO 20 MG
English: Clinically relevant non-major bleeding a) Rivaroxaban 20 mg once daily * p < 0.0001 (superiority), HR: 0.185 (0.087 - 0.393)
Slovenian: ++ Zdravilo Xarelto 10 mg enkrat na dan v primerjavi z acetilsalicilno kislino 100 mg enkrat na dan; razmerje tveganja = 0,32 (0,18-0,55), p < 0,0001 (nominalno)
English: Hypromellose 2910 Titanium dioxide (E 171) Iron oxide yellow (E 172)
Slovenian: Filmska obloga makrogol 3350 hipromeloza 2910 titanov dioksid (E 171)
English: EU/1/08/472/016 100 x 1 film-coated tablets (PP/Aluminium foil blisters) EU/1/08/472/038 10 film-coated tablets
Slovenian: EU/1/08/472/015 10 x 1 filmsko obložena tableta (pretisni omot iz PP/aluminija) EU/1/08/472/016 100 x 1 filmsko obložena tableta (pretisni omot iz PP/aluminija) EU/1/08/472/038 10 filmsko obloženih tablet
English: - if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6) - if you are bleeding excessively - if you have a disease or condition in an organ of the body that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding in the brain, recent surgery of the brain or eyes) - if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when changing anticoagulant treatment or while getting heparin through a venous or arterial line to keep it open - if you have an acute coronary syndrome and previously had a bleeding or a blood clot in your brain (stroke) - if you have coronary artery disease or peripheral artery disease and previously had a bleeding in your brain (stroke) or where there was a blockage of the small arteries providing blood to the brain's deep tissues (lacunar stroke) or if you had a blood clot in your brain (ischaemic, nonlacunar stroke) in the previous month - if you have a liver disease which leads to an increased risk of bleeding - if you are pregnant or breast-feeding
Slovenian: apiksaban ali heparin), razen pri spremembi/zamenjavi antikoagulacijskega zdravljenja ali ko dobivate heparin skozi venski ali arterijski kateter za vzdrževanje prehodnosti katetra, - če imate akutni koronarni sindrom in ste predhodno imeli krvavitev ali krvni strdek v možganih (možgansko kap), - če imate bolezen jeter, ki lahko poveča tveganje za krvavitve, - če ste noseči ali dojite,
English: PP/Aluminium foil blisters in cartons of 10, 14, 28 or 98 film-coated tablets or perforated unit dose blisters in cartons of 10 x 1, or 100 x 1 or in multipacks containing 100 (10 packs of 10 x 1) filmcoated tablets.
Slovenian: Škatla po 10, 14, 28 ali 98 filmsko obloženih tablet v pretisnih omotih iz PP/aluminija ali škatla po 10 x 1 ali 100 x 1 filmsko obložena tableta v perforiranih pretisnih omotih za enkratni odmerek ali v večkratnem pakiranju po 100 filmsko obloženih tablet (10 enot po 10 x 1 filmsko obložena tableta).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 14 TABLETS FOR 15 MG
Slovenian: PRETISNI OMOT S 14 TABLETAMI PO 15 MG
English: Light red, round biconvex tablets (6 mm diameter, 9 mm radius of curvature) marked with the BAYER-cross on one side and "10" and a triangle on the other side.
Slovenian: FARMACEVTSKA OBLIKA filmsko obložena tableta (tableta) svetlo rdeče, okrogle bikonveksne tablete (6 mm premera, 9 mm polmer ukrivljenosti), na eni strani označene z oznako BAYER (križ) in na drugi strani s številko »10« in trikotnikom
English: Hepatobiliary disorders
Slovenian: Srčne bolezni tahikardija
English: postoperative anaemia, and wound haemorrhage), contusion, wound secretionA
Slovenian: Bolezni sečil krvavitve v urogenitalnem traktu (tudi hematurija in menoragija
English: Bayer (logo)
Slovenian: Bayer OÜ
English: Relative Days from the Randomization
Slovenian: sekrecija iz raneA
English: Major bleeding events a) Rivaroxaban 15 mg twice daily for 3 weeks followed by 20 mg once daily b) Enoxaparin for at least 5 days, overlapped with and followed by VKA * p < 0.0001 (non-inferiority to a prespecified HR of 1.75); HR: 0.886 (0.661 - 1.186)
Slovenian: Simptomatska ponovna GVT 32 Simptomatska PE in GVT 1 Smrtna PE/smrt, pri kateri PE ni mogoče izključiti Velike ali klinično pomembne majhne krvavitve Velike krvavitve a) rivaroksaban v odmerku 15 mg dvakrat na dan 3 tedne, nato pa odmerek po 20 mg enkrat na dan b) enoksaparin vsaj 5 dni, sočasno zdravljenje z AVK in enoksaparinom in nadaljevanje zdravljenja z AVK * p < 0,0001 (neinferiornost glede na predhodno opredeljeno razmerje tveganja 1,75); razmerje tveganja: 0,886 (0,661 - 1,186)
English: 0.66 (0.46, 0.95) p = 0.026** a) modified intent to treat analysis set (intent to treat total analysis set for stent thrombosis) b) vs. placebo; Log-Rank p-value ** nominally significant
Slovenian: a) modificirana analiza z namenom zdravljenja (skupna analiza z namenom zdravljenja tromboze stenta) b) v primerjavi s placebom; p-vrednost Log-Rank
English: Uncommon (may affect up to 1 in 100 people) - bleeding into the brain or inside the skull - bleeding into a joint causing pain and swelling - thrombocytopenia (low number of platelets, which are cells that help blood to clot)
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) - krvavitev v možganih ali znotrajlobanjske krvavitve
English: Thrombocytosis (incl.
Slovenian: A, trombocitov) trombocitopenija
English: (See section 4.4 for haemodynamically unstable PE patients.)
Slovenian: GVT in PE pri odraslih bolnikih (glejte poglavje 4.4 glede podatkov o uporabi zdravila pri hemodinamsko nestabilnih bolnikih s PE).
English: For the primary efficacy outcome, the observed benefit of Xarelto 2.5 mg twice daily plus ASA 100 mg once daily compared with ASA 100 mg once daily was HR=0.89 (95% CI 0.7-1.1) in patients ≥75 years (incidence: 6.3% vs 7.0%) and HR=0.70 (95% CI 0.6-0.8) in patients <75 years (3.6% vs 5.0%).
Slovenian: Xarelto 2,5 mg dvakrat na dan, acetilsalicilna kislina 100 mg enkrat na dan acetilsalicilna kislina 100 mg enkrat na dan ocena po metodi Kaplan-Meier (%) po 30 mesecih: Xarelto 2,5 mg dvakrat na dan + acetilsalicilna kislina 100 mg enkrat na dan: 5,2 (4,7-5,8) acetilsalicilna kislina 100 mg enkrat na dan: 7,2 (6,5-7,9)
English: Weight:
Slovenian: Telesna masa:
English: The prespecified net clinical benefit (primary efficacy outcome plus major bleeding events) of the pooled analysis was reported with a HR of 0.771 ((95% CI: 0.614 - 0.967), nominal p value p=
Slovenian: O vnaprej določeni čisti klinični koristi zdravljenja (primarni izid učinkovitosti in velike krvavitve) analize zbranih podatkov so poročali z razmerjem tveganja 0,771 ((95 % IZ: 0,614 - 0,967),
English: Total VTE 18 (1.1%) 58 (3.7%) < 0.001 17 (2.0%) 81 (9.3%) < 0.001 79 (9.6%) 166 (18.9%) < 0.001 Major
Slovenian: (95 % IZ 0,7 - 1,1) pri bolnikih ≥ 75 let (incidenca: 6,3 % oziroma 7, 0 %) in 0,70 (95 % IZ 0,60,8) pri bolnikih < 75 let (3,6 % oziroma 5,0 %).
English: ♦ INR values should not be used as they are not a dependable measure of the anticoagulant activity of Xarelto.
Slovenian: Informacije za zdravnika: ♦ Določanje vrednosti INR ni ustrezno merilo za merjenje antikoagulacijskega učinka zdravila
English: Brown-red, round biconvex tablets (6 mm diameter, 9 mm radius of curvature) marked with the BAYER-cross on one side and “20” and a triangle on the other side.
Slovenian: FARMACEVTSKA OBLIKA filmsko obložena tableta (tableta) rjavordeče, okrogle bikonveksne tablete (6 mm premera, 9 mm polmer ukrivljenosti), na eni strani označene z oznako BAYER (križ) in na drugi strani s številko »20« in trikotnikom
English: Symptomatic recurrent DVT
Slovenian: simptomatske VTE
English: Day 1 - 21: 30 mg Day 22 and onwards: 20 mg
Slovenian: - 21. dan: 30 mg
English: ASA 100mg od: 7.2 (6.5 - 7.9)
Slovenian: Razmerje ogroženosti (95% IZ) 0,76 (0,66 do 0,86)
English: All doses should be taken every 12 hours.
Slovenian: Vse odmerke je treba jemati vsakih 12 ur.
English: If this is not possible, it may be taken with a light meal.
Slovenian: Če to ni mogoče, ga je mogoče vzeti tudi z lahkim obrokom.
English: Zerit stavudine
Slovenian: Zerit stavudin
English: The effectiveness of Zerit was assessed in four main studies.
Slovenian: Učinkovitost zdravila Zerit so ocenjevali v štirih glavnih študijah.
English: This study measured survival rates.
Slovenian: V tej študiji so merili stopnje preživetja.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zerit on 8 May 1996.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Zerit, veljavno po vsej Evropski uniji, izdala 8. maja 1996.
English: Other information about Zerit
Slovenian: Druge informacije o zdravilu Zerit
English: The full EPAR for Zerit 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 Zerit je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It is available as capsules containing 15, 20, 30 and 40 mg stavudine.
Slovenian: Na voljo je v obliki kapsul (15, 20, 30 in 40 mg).
English: The capsules should be swallowed whole or opened carefully and their contents mixed with food.
Slovenian: Kapsule mora bolnik pogoltniti cele ali pa jih previdno odpreti in njihovo vsebino zmešati s hrano.
English: The most common side effects when taking Zerit (seen in between 1 and 10 patients in 100) are peripheral neuropathy (damage to the nerves in the extremities causing tingling, numbness and pain in the hands and feet), diarrhoea, nausea, abdominal (stomach) pain, dyspepsia (heartburn), tiredness, lipoatrophy (a loss of fat in some areas of the body which can cause disfigurement), dizziness, insomnia (difficulty sleeping), abnormal thinking or dreams, somnolence (sleepiness), headache, depression, rash, pruritus (itching) and hyperlactataemia (elevated lactic acid levels in the blood).
Slovenian: Najpogostejši neželeni učinki, ki so jih opazili pri jemanju zdravila Zerit (opaženi pri med 1 in 10 bolniki od 100) so periferna nevropatija (poškodbe živcev okončin, kar povzroča ščemenje, odrevenelost in bolečino v rokah ter nogah), driska, slabost, abdominalne (trebušne) bolečine, dispepsija (zgaga), utrujenost, lipoatrofija (izguba maščevja na nekaterih delih telesa, kar lahko povzroči popačenje), vrtoglavica, nespečnost, nenormalno mišljenje, somnolenca (zaspanost), depresija, izpuščaj, pruritus (srbenje) in hiperlaktatemija (povišana raven mlečne kisline v krvi).
English: Patients taking either of two doses of Zerit also had similar survival rates over 22 weeks.
Slovenian: Bolniki, ki so jemali enega od obeh odmerkov zdravila Zerit, so imeli tudi podobne stopnje preživetja v času 22 tednov.
English: Patients taking Zerit should be assessed frequently.
Slovenian: Bolnike, ki jemljejo zdravilo Zerit, je treba redno spremljati.
English: What benefit has Zerit shown during the studies?
Slovenian: Kakšne koristi je zdravilo Zerit izkazalo med študijami?
English: Zerit should be taken on an empty stomach, at least one hour before a meal.
Slovenian: Zdravilo Zerit je treba vzeti na tešče vsaj eno uro pred obrokom.
English: What is the risk associated with Zerit?
Slovenian: Kakšna tveganja so povezana z zdravilom Zerit?
English: The second study compared two doses of Zerit in over 13,000 patients who did not respond to, or could not take, other types of antiviral medicine.
Slovenian: V drugi študiji so primerjali dva odmerka zdravila Zerit pri več kot 13 000 bolnikih, ki se niso odzivali oziroma niso mogli jemati drugih vrst protivirusnih zdravil.