FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncommon: abdominal distention, acid reflux, bowel movement pattern change, constipation, dry mouth, gastroduodenal ulcer, irritable bowel syndrome, oesophagitis, oral ulcer, vomiting, gastritis.
Slovenian: Občasne: napihnjen trebuh, refluks kisline, spremenjen vzorec iztrebljanja, zaprtje, suha usta, razjeda želodca in dvanajstnika, sindrom iritabilnega kolona, ezofagitis, razjeda v ustih, bruhanje.
English: Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids, coxibs, ATC Code: M01 AH05
Slovenian: Farmakoterapevtska skupina: Nesteroidni protivnetni in protirevmatični pripravki, koksibi
English: The recommended dose is 30 mg once daily.
Slovenian: Osteoartroza Priporočeni odmerek je 60 mg enkrat na dan.
English: The clinical significance of these increases is unknown, and higher doses of PREMARIN were not studied in combination with etoricoxib.
Slovenian: Večjih odmerkov zdravila PREMARIN <ali lokalna BLAGOVNA ZNAMKA> v kombinaciji z etorikoksibom niso preučili.
English: Eye disorders: Uncommon: blurred vision, conjunctivitis.
Slovenian: Očesne bolezni: Občasne: zamegljen vid.
English: <Etoricoxib containing medicinal products (see Annex 1)> 60 mg film-coated tablets < Etoricoxib containing medicinal products (see Annex 1)> 90 mg film-coated tablets < Etoricoxib containing medicinal products (see Annex 1)> 120 mg film-coated tablets [See Annex I - To be completed nationally]
Slovenian: IME ZDRAVILA < IZMIŠLJENO IME (glejte Priloga 1)> 60 mg filmsko obložene tablete < IZMIŠLJENO IME (glejte Priloga 1)> 90 mg filmsko obložene tablete < IZMIŠLJENO IME (glejte Priloga 1)> 120 mg filmsko obložene tablete
English: Elevations of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) (approximately three or more times the upper limit of normal) have been reported in approximately 1% of patients in clinical trials treated for up to one year with etoricoxib 30, 60 and 90 mg daily.
Slovenian: V kliničnih raziskavah so pri približno 1 % bolnikov, ki so se do enega leta zdravili s 60 in 90 mg etorikoksiba dnevno, poročali o dvigu alanin aminotransferaze (ALT) in/ali aspartat aminotransferaze (AST) (približno tri- ali več-kratna zgornja meja normalne vrednosti).
English: Therefore, hypertension should be controlled before treatment with etoricoxib (see section 4.3) and special attention should be paid to blood pressure monitoring during treatment with etoricoxib.
Slovenian: Zato mora biti med zdravljenjem z etorikoksibom posebna pozornost namenjena kontroli krvnega tlaka.
English: Efficacy
Slovenian: Jakost
English: Patients with moderate hepatic dysfunction (Child-Pugh score 7-9) administered etoricoxib 60 mg every other day had similar mean AUC to the healthy subjects given etoricoxib 60 mg once daily; etoricoxib 30 mg once daily has not been studied in this population.
Slovenian: Bolniki z zmerno motnjo delovanja jeter (lestvica po Child-Pughu 7-9), ki so dobivali 60 mg etorikoksiba vsak drugi dan, so imeli povprečno AUC podobno kot zdravi preiskovanci, ki so jemali etorikoksib 60 mg enkrat na dan. Kliničnih ali farmakokinetičnih podatkov za bolnike s hudo motnjo delovanja jeter (lestvica po Child-Pughu ≥ 10) nimamo.
English: Patients with hypertension whose blood pressure is persistently elevated above 140/90mmHg and has not been adequately controlled.
Slovenian: Bolniki z visokim krvnim tlakom, ki ni zadostno nadzorovan.
English: National competent authorities (NCA) shall ensure that the following conditions are fulfilled by the marketing authorisation holders:
Slovenian: Pristojne oblasti držav članic bodo podatke o izdelku posodobile v skladu z zahtevami, ko bo podana odločba Komisije.
English: 60 mg - 90 mg -120mg 2 Film coated tablets 5 Film-coated tablets 7 Film-coated tablets 10 Film-coated tablets 14 Film-coated tablets 20 Film-coated tablets 28 Film-coated tablets 30 Film-coated tablets 50 Film-coated tablets 84 Film-coated tablets 98 Film-coated tablets 100 Film-coated tablets 50 Film-coated tablets (unit dose) 100 Film-coated tablets (unit dose) 30 Film-coated tablets (HDPE bottles) 90 Film-coated tablets (HDPE bottles)
Slovenian: zloženke po 7 tablet: 5363-I-649/02 zloženke po 14 tablet: 5363-I-650/02 zloženke po 28 tablet: 5363-I-651/02 120 mg: zloženke po 7 tablet: 5363-I-652/02 zloženke po 14 tablet: 5363-I-653/02 zloženke po 28 tablet: 5363-I-654/02
English: Belgium Merck Sharp and Dohme Chaussée de Waterloo 1135
Slovenian: Merck Sharp&Dohme s.a. 1180, Chaussée de Waterloo B-1135 Bruxelles Belgija
English: - In view of the available data, the CHMP considered that the benefit/risk balance for etoricoxib 90mg dose in the RA and AS indications is positive; however, revisions to the contraindications and warnings sections have been added to the summary of product characteristics and package leaflet in relation to cardiorenal safety.
Slovenian: Ob upoštevanju, da je CHMP - mnenja, da razmerje med koristjo in tveganjem za zdravila, ki vsebujejo etorikoksib, za dogovorjene indikacije ostaja ugodno in da se dovoljenja za promet ohranijo v skladu s popravljenimi Povzetki glavnih značilnosti zdravil (priloženimi mnenju CHMP v Dodatku III), - zaključil, da je treba kardiovaskularno varnost in hude kožne reakcije neprekinjeno in natančno spremljati in vrednotiti, - in priporočil nadaljnje ukrepe z namenom dodatnega raziskovanja varnosti etorikoksiba.
English: Per-protocol
Slovenian: Peroralna uporaba
English: White, round, HDPE bottles with a white, polypropylene closure containing 30 tablets and two1-gram desiccant containers or 90 tablets and one1-gram desiccant container.
Slovenian: Bele, okrogle HDPE plastenke z belim polipropilenskim zamaškom s 30 ali 90 tabletami.
English: PHARMACEUTICAL FORM AND CONTENTS
Slovenian: FARMACEVTSKA OBLIKA
English: Skanstes 13
Slovenian: DODATEK III
English: The difference in antiplatelet activity between some COX-1 inhibiting NSAIDs and selective COX-2 inhibitors may be of clinical significance in patients at risk of thrombo-embolic events.
Slovenian: Vendar je bil delež teh zapletov večji pri bolnikih, ki so dobivali etorikoksib, kot pri tistih, ki so jemali naproksen 500 mg dvakrat na dan. Razlika v antitrombotičnem delovanju med nekaterimi NSAR-i, ki zavirajo COX-1, in selektivnimi zaviralci COX-2 je lahko klinično pomembna pri bolnikih s tveganjem za tromboembolične dogodke.
English: Rate
Slovenian: Opis
English: Merck Sharp & Dohme GmbH Donau - City - Straße 6 A-1220 Wien
Slovenian: Merck Sharp & Dohme GmbH Donau-City-Straße 6
English: Addenda Pharma S.r.l Viale Shakespeare, 47 00144 Roma Italy
Slovenian: Via dei Santi Pietro e Paolo, 30 00144 Roma Italija
English: Merck Sharp & Dohme de España, S.A., Josefa Valcárcel, 38 28027 Madrid Spain
Slovenian: Merck Sharp & Dohme de España S.A. Josefa Valcárcel 38
English: Merck Sharp and Dohme Ltd Hertford Road
Slovenian: Merck Sharp & Dohme Limited Hertford Road
English: - A direct healthcare professional communication (DHPC) must be sent to all healthcare professionals who prescribe etoricoxib according to national practice.
Slovenian: Nadaljnje revizije SPC-ja se nemudoma sporočijo poklicnim zdravstvenim delavcem (Health Care Professionals, HCP) in se takoj vnesejo v vse tiskano gradivo in objave na spletnih straneh.
English: 90 mg white, apple-shaped, biconvex film coated tablets marked ‘ARCOXIA 90' on one side and ‘202' on the other.
Slovenian: 90 mg tablete: Bele, bikonveksne tablete v obliki jabolka, z oznako "454" na eni strani ter "MSD" na drugi strani.
English: Uncommon: facial oedema, pruritus, rash.
Slovenian: Občasne: ekhimoza, edemi obraza, pruritus, izpuščaj.
English: NAME OF THE MEDICINAL PRODUCT
Slovenian: Država članica Imetnik dovoljenja za promet z zdravilom
English: Merck Sharp & Dohme, Lda.
Slovenian: Merck Sharp & Dohme, Lda Quinta Da Fonte
English: UAB, Merck Sharp & Dohme“, Lenktoji str. 27/ Kestucio str. 59 LT-08124 Vilnius Lithuania
Slovenian: Merck Sharp & Dohme UAB, Lithuania Gelezinio Vilko 18A 01112 Vilnius
English: The rates per hundred patient-years of confirmed complicated and uncomplicated upper GI clinical events (perforations, ulcers and bleeds (PUBs)) were 0.67 (95% CI 0.57, 0.77) with etoricoxib and 0.97 (95% CI 0.85, 1.10) with diclofenac, yielding a relative risk of 0.69 (95% CI 0.57, 0.83).
Slovenian: Deleža resnih trombotičnih dogodkov sta bila: pri etorikoksibu 1,25 dogodka na 100 bolnikov-let, pri diklofenaku pa 1,15 dogodka na 100 bolnikov-let (relativno tveganje 1,07, 95 % interval zaupanja: 0,65 %, 1,74 %).
English: Etoricoxib was included in previous CHMP referrals on the safety of COX-2 selective inhibitors in which concluded in 2004 and 2005.
Slovenian: CHMP je o kardiovaskularni varnosti razpravljal na svoji seji februarja 2005.
English: Metabolism
Slovenian: Tableta
English: Ear and labyrinth disorders: Uncommon: tinnitus, vertigo.
Slovenian: Ušesne bolezni, vključno z motnjami labirinta: Občasne: tinitus.
English: Concomitant administration of etoricoxib with doses of acetylsalicylic acid above those for cardiovascular prophylaxis or with other NSAIDs is not recommended (see sections 5.1 and 4.4.
Slovenian: Sočasnega zdravljenja z etorikoksibom in acetilsalicilno kislino v odmerkih, večjih od tistih za preprečevanje srčno-žilnih bolezni, ali z drugimi NSAR-i ne priporočamo.
English: CONDITIONS OF THE MARKETING AUTHORISATION
Slovenian: PODLAGA ZA DOPOLNILO DOVOLJENJA ZA PROMET
English: There was no significant difference between etoricoxib and diclofenac in the rate of complicated events.
Slovenian: Med etorikoksibom in placebom ni bilo statistično značilne razlike.
English: In the study, the incidence of discontinuations due to hypertension-related adverse events was statistically significantly higher for etoricoxib than for diclofenac.
Slovenian: Pojavnost kliničnih dogodkov v prebavilih, ki so pripeljali do prekinitve zdravljenja, je bila statistično pomembno manjša pri etorikoksibu kot pri diklofenaku (7,1 % proti 9,1 %).
English: As a consequence, the CHMP has recommended to maintain the Marketing Authorisation for all medicinal products containing 90 mg of etoricoxib referred to in Annex I of the Opinion and to amend the relevant sections of the summary of product characteristics and package leaflet, as set out in Annex III of the Opinion in accordance with Article 31 (2) of Directive 2001/83/EC, as amended.
Slovenian: V zvezi z razpravo Odbora za zdravila za uporabo v humani medicini (CHMP) na plenarni seji oktobra 2004 je Evropska komisija priporočila, da se za to javno zdravstveno vprašanje o vseh vidikih kardiovaskularne varnosti, vključno s trombotičnimi dogodki in kardiorenalnimi dogodki, sproži napotitveni postopek Skupnosti v skladu z 31. členom Direktive 2001/83/ES z vsemi dodatki za zdravila, odobrena po decentraliziranem postopku, in vsebujejo celekoksib, etorikoksib in lumirakoksib ter revizijski postopek v skladu z 18. členom Uredbe Sveta (EGS) št. 2309/93 z vsemi dodatki za zdravila, odobrena po centraliziranem postopku, in vsebujejo celekoksib (Onsenal), parekoksib (Dynastat/Rayzon) in valdekoksib (Bextra/Valdyn).
English: The EDGE study included 7111 OA patients treated with a dose of etoricoxib 90 mg daily (1.5 times the dose recommended for OA) or diclofenac 150 mg daily for a mean period of 9.1 months (maximum 16.6 months, median 11.4 months).
Slovenian: V raziskavi s približno 7.100 bolniki z osteoartrozo so primerjali prenašanje etorikoksiba 90 mg (1,5kratni priporočeni odmerek pri OA) in diklofenaka 150 mg v prebavilih.
English: 60 mg dark green, apple-shaped, biconvex film coated tablets marked ‘ARCOXIA 60' on one side and ‘200' on the other.
Slovenian: 60 mg tablete: Zelene, bikonveksne tablete v obliki jabolka, z oznako "447" na eni strani ter "MSD" na drugi strani.
English: The rate per hundred patient-years was 0.22 on etoricoxib and 1.84 for diclofenac (p-value was <0.001 for etoricoxib vs. diclofenac).
Slovenian: Deleža ishemičnih možganskih kapi sta bila 0,14 proti 0,23 na 100 bonikov-let za etorikoksib oz. diklofenak.
English: In rabbits, a treatment related increase in cardiovascular malformations was observed at exposure levels below the clinical exposure at the daily human dose (90 mg).
Slovenian: Pri podganah in kuncih niso ugotovili vpliva na zarodek/plod pri sistemski izpostavitvi, enaki ali manjši od priporočenega dnevnega odmerka pri človeku (90 mg).
English: MEDAL Program Gastrointestinal Safety Results:
Slovenian: V raziskavi so prišli še do naslednjih ugotovitev v zvezi z varnostjo:
English: The CHMP concluded on 26 June 2008 that the data confirm the known relatively adverse renovascular safety profile of etoricoxib (hypertension, oedema and congestive heart failure), but similar CV thrombotic risk as diclofenac and some degree of upper GI safety advantage over naproxen and diclofenac (though no particular lower GI safety advantage).
Slovenian: - novih podatkov, ki jih je za rofekoksib prispevala klinična raziskava APPROVe in ki kažejo tveganje za trombotične kardiovaskularne dogodke, - podatkov za celekoksib iz raziskave APC, ki so nakazali povečanje tveganja hudih kardiovaskularnih dogodkov, ki so odvisni od odmerka, - podatkov za valdekoksib in parekoksib iz raziskav CABG (Coronary Artery Bypass Graft) in CABG II, ki kažejo višjo stopnjo hudih kardiovaskularnih tromboembolijskih dogodkov v skupinah bolnikov, ki so se zdravili s parekoksibom/valdekoksibom, v primerjavi s skupino bolnikov, ki je prejemala placebo, - podatkov za etorikoksib iz raziskave EDGE ter analiz združenih podatkov iz drugih kliničnih preizkušanj, ki nakazujejo povezavo z večjim tveganjem za trombotične dogodke v primerjavi z naproksenom; - podatkov za lumirakoksib iz raziskave Target, ki nakazujejo majhno povečanje trombotičnih dogodkov (zlasti miokardnega infarkta) v primerjavi z naproksenom,
English: 30 mg: lactose 1.4 mg 60 mg: lactose 2.8 mg 90 mg: lactose 4.2 mg 120 mg: lactose 5.6 mg
Slovenian: 60 mg: zloženke po 7 tablet: 5363-I-646/02 zloženke po 14 tablet: 5363-I-647/02 zloženke po 28 tablet: 5363-I-648/02 90 mg:
English: Cardiorenal Events:
Slovenian: Srčno-žilni podatki:
English: In the pooled MEDAL Program, 0.3% of patients on etoricoxib and 2.7% of patients on diclofenac discontinued due to hepatic-related adverse experiences.
Slovenian: Pojavnost prekinitev zaradi edemov pa je bila 0,9 % za etorikoksib, za diklofenak pa 0,7 %.
English: In patients with moderate hepatic dysfunction (Child-Pugh score 7-9), regardless of indication, the dose of 60 mg every other day should not be exceeded; administration of 30 mg once daily can also be considered.
Slovenian: Pri bolnikih z zmerno motnjo delovanja jeter (lestvica po Child-Pughu 7-9) ne smemo prekoračiti priporočenega odmerka 60 mg vsak drugi dan. Klinične izkušnje so še posebej omejene pri bolnikih z zmerno motnjo delovanja jeter, zato svetujemo previdnost.
English: SIA Merck Sharp & Dohme Latvija,
Slovenian: SIA ”Merck Sharp & Dohme Latvija” Skanstes iela 13
English: Merck, Sharp & Dohme Ltd Hertfordshire Road Hoddesdon
Slovenian: Merck Sharp & Dohme Ltd. Šmartinska cesta 140
English: PRT
Slovenian: Presnova
English: 120 mg pale-green, apple-shaped, biconvex film coated tablets marked ‘ARCOXIA 120' on one side and ‘204' on the other.
Slovenian: Svetlo zelene, bikonveksne tablete v obliki jabolka, z oznako "541" na eni strani ter "MSD" na drugi strani.
English: There have been reports of acute overdosage with etoricoxib, although adverse experiences were not reported in the majority of cases.
Slovenian: V kliničnih raziskavah niso poročali o primerih prevelikega odmerjanja.
English: The upper GI benefit for etoricoxib compared with diclofenac was not statistically significant in patients taking concomitant low-dose aspirin (approximately 33% of patients).
Slovenian: Neželeni učinki v jetrih: Etorikoksib je bil v primerjavi z diklofenakom povezan s statistično pomembno manjšim deležem prekinitev zdravljenja predvsem zaradi povišanj vrednosti testov jetrne funkcije (0,3 % proti 5,2 %).
English: The rate of confirmed thrombotic cardiovascular serious adverse events (consisting of cardiac, cerebrovascular, and peripheral vascular events) was comparable between etoricoxib and diclofenac, and data are summarized in the table below.
Slovenian: Deleži potrjenih perforacij, razjed in krvavitev zgornjih prebavil so bili pri etorikoksibu in diklofenaku enaki (1,11 dogodka na 100 bolnikov-let).
English: If you are using <Etoricoxib>, you must not breastfeed.
Slovenian: Ženske, ki jemljejo etorikoksib, ne smejo dojiti.
English: Patients with a recent history of myocardial infarction, coronary artery bypass grafting or percutaneous coronary intervention within 6 months preceding enrollment were excluded.
Slovenian: Vpliv etorikoksiba, celekoksiba in naproksena na izločanje natrija v urinu je bil v 2 tednih zdravljenja podoben.
English: People with liver problems
Slovenian: Učinki na jetra
English: In the absence of an increase in therapeutic benefit, other therapeutic options should be considered.
Slovenian: Če se krni tlak pomembno zviša, je treba razmisliti o nadomestnem zdravljenju.
English: POSSIBLE SIDE EFFECTS
Slovenian: Učinki na prebavila
English: In March 2006, the marketing authorisation holders (MAH) for etoricoxib submitted an application to extend the licensed indication to include treatment of ankylosing spondylitis (AS), at a recommended daily dose of 90mg.
Slovenian: Septembra 2004 je imetnik dovoljenja za promet z rofekoksibom (selektivnim zaviralcem Cox-2) obvestil Evropsko agencijo za zdravila, da so podatki iz novega kliničnega preizkušanja (APPROVe) rofekoksiba pokazali tveganje za trombotične kardiovaskularne dogodke.
English: Blisters: Store in the original package in order to protect from moisture.
Slovenian: Pretisni omoti: Shranjujte v originalni ovojnini.
English: However, the rate of these events was higher in patients receiving etoricoxib compared with those receiving naproxen 500 mg twice daily.
Slovenian: Tveganje za te opazovane dogodke je bilo približno za 50 % manjše pri bolnikih, ki so se zdravili z etorikoksibom (60, 90 ali 120 mg dnevno), v primerjavi z bolniki, ki so dobivali naproksen 500 mg dvakrat na dan ali diklofenak 50 mg trikrat na dan.
English: These led to updates of the product information to include class warnings on the risk of CV thrombotic, GI and severe skin reactions with COX-2 selective inhibitors.
Slovenian: - Okrepljeno je opozorilo, ki poudarja, da so se pri uporabi zaviralcev COX-2 pojavile usodno hude kožne reakcije.
English: Paço d' Arcos
Slovenian: Učinki na ledvice
English: A significantly lower rate of discontinuations of treatment for any clinical (e.g., dyspepsia, abdominal pain, ulcer) GI adverse event was observed with etoricoxib compared with diclofenac within each of the three component studies of the MEDAL Program.
Slovenian: Prenašanje in varnost v prebavilih: Etorikoksib je bil v primerjavi z diklofenakom povezan s statistično pomembno manjšo pojavnostjo prekinitev zdravljenja pri bolnikih zaradi vnaprej opredeljenega sestavljenega končnega dogodka: kliničnih neželenih učinkov v prebavilih in laboratorijskih neželenih učinkov v povezavi s povišanimi vrednostmi testov jetrne funkcije.
English: The CHMP therefore recommends the strengthening of the contraindication in hypertensive patients and alerts prescribers that blood pressure needs to be monitored, especially within 2 weeks of treatment initiation.
Slovenian: - Dodano je opozorilo v zvezi s hipertenzijo in spremljanjem krvnega tlaka med zdravljenjem z etorikoksibom.
English: The CHMP reviewed the data submitted by the marketing authorisation holders from clinical trials, drug utilisation studies and spontaneous reporting of adverse drug reactions.
Slovenian: Nadaljnji ukrepi imetnika dovoljenja za promet z zdravilom Glede na zahteve CHMP-ja se je imetnik dovoljenja za promet strinjal, da bo izvedel nadaljnje ukrepe kot so navedeni spodaj
English: Therefore, France sent a notification that was received by the EMEA on 19 September 2007 and a referral under Article 31 of Directive 2001/83/EC, as amended was started on 20 September 2007.
Slovenian: Nujen varnostni ukrep se je začel 16. februarja 2005 in zaključil 17. februarja 2005.
English: The cardiorenal results for EDGE and EDGE II were consistent with those described for the MEDAL Study.
Slovenian: Imetnik dovoljenja za promet se zavezuje, da bo obvestil CHMP o izidu študij MEDAL in EDGE II o kardiovaskularni in gastrointestinalni varnosti po njunem zaključku in ustrezno predložil potrebne posodobljene podatke.
English: List of the names, pharmaceutical form, strength of the medicinal product(s), route of administration, marketing authorisation holders in the member states
Slovenian: Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravil, poti uporabe, imetnikov dovoljenj za promet v državah članicah
English: Marketing authorisaton holder
Slovenian: Imetnik dovoljenja za promet
English: Jenapharm GmbH & Co. KG Otto-Schott-Str. 15
Slovenian: KG Otto-Schott-Str. 15
English: Product name
Slovenian: Ime
English: Withdrawal period
Slovenian: Lastniško ime
English: Raxone idebenone
Slovenian: Raxone idebenon
English: This is a summary of the European public assessment report (EPAR) for Raxone.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Raxone.
English: European Medicines Agency will review any new information that becomes available and this summary will be updated as necessary.
Slovenian: Evropska agencija za zdravila bo vsako leto ponovno pregledala vse nove podatke, ki bodo na voljo, in posodobila povzetek glavnih značilnosti zdravila, če bo potrebno.
English: What measures are being taken to ensure the safe and effective use of Raxone?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Raxone?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Raxone are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Raxone večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: Patients affected by LHON have mutations (defects) in the genetic material of mitochondria.
Slovenian: Bolniki z LKON imajo mutacije (okvare) v genskem materialu mitohondrijev.
English: The main measure of effectiveness was improvement in vision, mostly based on the numbers of letters patients were able to read on a standard eye test chart.
Slovenian: Glavno merilo učinkovitosti je bilo izboljšanje vida, ki je večinoma temeljilo na številu črk, ki so jih lahko bolniki prebrali s standardnega kartona za preverjanje vida.
English: Raxone is available as 150 mg tablets, and the recommended dose is two tablets taken three times a day with food.
Slovenian: Zdravilo Raxone je na voljo v obliki 150-miligramskih tablet, priporočeni odmerek pa je dve tableti trikrat na dan, skupaj s hrano.
English: Raxone has been authorised under ‘exceptional circumstances'.
Slovenian: Zdravilo Raxone je pridobilo dovoljenje za promet „v izjemnih okoliščinah“.
English: Furthermore, some patients who were classified as ‘off chart' (unable to read any letters on the chart) at the beginning of the study were able to read at least one line during the eye test after treatment, and this was also considered clinically important.
Slovenian: Poleg tega so lahko bolniki, ki so bili na začetku študije razvrščeni kot „zunaj kartona“ (niso bili sposobni prebrati nobenih črk s kartona), prebrali vsaj eno vrstico med preverjanjem vida po zdravljenju, kar je bilo klinično pomembno.
English: A risk management plan has been developed to ensure that Raxone is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Raxone je bil pripravljen načrt obvladovanja tveganj.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Raxone can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu Raxone je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.