FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, QT prolongation (a change in the heart's electrical activity) and cases of serious heart problems presented a safety concern.
Slovenian: Poleg tega so podaljšanje intervala QT (sprememba električne dejavnosti srca) in primeri hudih težav s srcem predstavljali varnostni zadržek.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 May 2016
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27.
English: The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Slovenian: Vlogo so umaknili po tem, ko je odbor CHMP ocenil začetno dokumentacijo, ki jo je predložila družba, in oblikoval seznam vprašanj.
English: The data provided were too limited to enable evaluation of the effectiveness of Xegafri at this time.
Slovenian: Predloženi podatki so bili preveč omejeni, da bi takrat omogočili ovrednotenje učinkovitosti zdravila Xegafri.
English: In these studies, Xegafri is not compared with any other treatment.
Slovenian: V teh študijah zdravila Xegafri niso primerjali z nobenim drugim zdravilom.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that it was withdrawing its application because of a revised business strategy for the product.
Slovenian: Družba je v dopisu, s katerim agencijo obvešča o umiku vloge, navedla, da se je za umik vloge odločila zaradi prenovljene poslovne strategije v zvezi z zdravilom.
English: The company informed the CHMP that they will stop enrolling patients in the ongoing clinical trials.
Slovenian: Družba je obvestila odbor CHMP, da bo prenehala vključevati bolnike v klinična preskušanja, ki trenutno potekajo.
English: In lung cancer cells, EGFR is often overactive, causing uncontrolled division of cancer cells.
Slovenian: V rakavih celicah pljuč je EGRF pogosto čezmerno dejaven in povzroča nenadzorovano delitev rakavih celic.
English: In addition, patients currently receiving Xegafri through a compassionate use programme can continue to receive this medicine.
Slovenian: Tudi bolniki, ki trenutno prejemajo zdravilo Xegafri v okviru programa sočutne uporabe, ga bodo lahko še naprej prejemali.
English: Withdrawal of the marketing authorisation application for Xegafri (rociletinib) EMA/352428/2016
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Xegafri (rociletinib) EMA/352428/2016
English: Xegafri is a medicine that contains the active substance rociletinib.
Slovenian: Xegafri je zdravilo, ki vsebuje zdravilno učinkovino rociletinib.
English: The company will continue to provide Xegafri to patients whose doctor recommend they should continue to take this medicine.
Slovenian: Še naprej bo zagotavljala zdravilo Xegafri bolnikom, ki jim bo zdravnik priporočil nadaljnje zdravljenje z njim.
English: This means that it blocks the activity of enzymes known as tyrosine kinases, particularly tyrosine kinases that are present in EGFRs.
Slovenian: To pomeni, da zavira delovanje encimov, znanih kot tirozin-kinaze, zlasti tirozin-kinaz, prisotnih v EGFR.
English: On 3 May 2016, Clovis Oncology UK Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Xegafri, for the treatment of non-small cell lung cancer.
Slovenian: Družba Clovis Oncology UK Ltd je 3. maja 2016 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Xegafri, namenjenim zdravljenju nedrobnoceličnega pljučnega raka.
English: What was Xegafri expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Xegafri uporabljalo?
English: What is Xegafri?
Slovenian: Kaj je zdravilo Xegafri?
English: Xegafri was to be used to treat a type of lung cancer called non-small cell lung cancer (NSCLC) in adults who have the T790M mutation (a particular change in the gene for a protein called epidermal growth factor receptor or EGFR) and who had already been treated with EGFR-targeted therapy.
Slovenian: Zdravilo Xegafri naj bi se uporabljalo za zdravljenje vrste pljučnega raka, imenovanega nedrobnocelični pljučni rak (NSCLC), pri odraslih, ki imajo mutacijo T790M (določeno spremembo v genu za beljakovino, imenovano receptor epidermalnega rastnega faktorja oziroma EGFR), in ki so se že zdravili z zdravili, ki delujejo proti EGFR.
English: Unlike most other tyrosine kinase inhibitors, rociletinib targets cancer cells with the T790M mutation in the EGFR gene.
Slovenian: V nasprotju z večino drugih zaviralcev tirozin-kinaze rociletinib deluje proti rakavim celicam z mutacijo T790M v genu za EGFR.
English: By blocking the tyrosine kinase in EGFR, rociletinib is expected to help reduce the growth and spread of the cancer.
Slovenian: Rociletinib naj bi z zaviranjem tirozin-kinaze v EGFR pripomogel k zmanjšani rasti in širjenju raka.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Xegafri did not outweigh its risks.
Slovenian: Zato je odbor CHMP v času umika menil, da koristi zdravila Xegafri ne odtehtajo z njim povezanih tveganj.
English: Withdrawal of the marketing authorisation application for Xegafri (rociletinib)
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Xegafri (rociletinib)
English: Based on the review of the data, at the time of the withdrawal, the CHMP had had some concerns and was of the provisional opinion that Xegafri could not have been approved for the treatment of NSCLC patients who have the T790M mutation.
Slovenian: Na podlagi pregleda podatkov je odbor CHMP v času umika izrazil določene zadržke in je začasno menil, da zdravila Xegafri ni mogoče odobriti za zdravljenje bolnikov z nedrobnoceličnim pljučnim rakom, ki imajo mutacijo T790M.
English: Xegafri is being investigated in two studies in 457 NSCLC patients who have the T790M mutation and had already been treated with EGFR-targeted therapy.
Slovenian: Zdravilo Xegafri proučujejo v dveh študijah pri 457 bolnikih z nedrobnoceličnim pljučnim rakom, ki imajo mutacijo T790M in so se že zdravili z zdravili, ki delujejo proti EGFR.
English: The active substance in Xegafri, rociletinib, is a tyrosine kinase inhibitor.
Slovenian: Zdravilna učinkovina v zdravilu Xegafri, rociletinib, je zaviralec tirozin-kinaze.
English: How is Xegafri expected to work?
Slovenian: Kako naj bi zdravilo Xegafri delovalo?
English: 1 ml (100 mg/ml) 2 (2 x 1) pre-filled syringes (multipack)
Slovenian: 2 (2 x 1) napolnjeni injekcijski brizgi (večje pakiranje)
English: 1 ml (100 mg/ml) 1 pre-filled syringe
Slovenian: 1 napolnjen injekcijski peresnik napolnjena injekcijska brizga (steklo) v napolnjenem injekcijskem peresniku
English: 2 pre-filled syringes + 2 safety needles
Slovenian: 2 napolnjeni injekcijski brizgi + 2 varnostni igli
English: 1 pre-filled syringe + 1 safety needle
Slovenian: 1 napolnjena injekcijska brizga + 1 varnostna igla
English: Invented name Strength Pharmaceutical Form
Slovenian: številka EU izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina velikost pakiranja
English: 3 years.
Slovenian: 2 leti.
English: D-85540 Haar
Slovenian: 85540 Haar
English: Šmartinska 140
Slovenian: Šmartinska cesta 140
English: 00191 Roma
Slovenian: I-00191 Roma
English: 1123 Budapest Hungary
Slovenian: H-1123 Budapest Madžarska
English: Farmacox - Companhia Farmacêutica Sociedade Unipessoal, Lda.
Slovenian: Farmacox-Companhia Farmacêutica, Lda.
English: 1000 Ljubljana Slovenia
Slovenian: SI-1000 Ljubljana Slovenija
English: [Very Common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000), not known (cannot be estimated from the available data)]
Slovenian: [Zelo pogosti (>1/10), pogosti (> 1/100, < 1/10), občasni (> 1/1000, < 1/100), redki (> 1/10.000, < 1/1.000), zelo redki (< 1/10.000 vključno s posameznimi primeri)]
English: Via Benedetto Croce, 37 56125 Pisa
Slovenian: Via Benedetto Croce, 37 I-56125 Pisa Italija
English: Patients appear to be at highest risk for these reactions early in the course of therapy with the onset of the reaction occurring in the majority of cases within the first month of treatment.
Slovenian: Kaže, da je tveganje za te reakcije največje kmalu po začetku zdravljenja, v večini primerov z nastopom v prvem mesecu zdravljenja.
English: Very rare: hypertensive crisis.
Slovenian: Zelo redke:hipertenzivna kriza.
English: Riga, LV-1013
Slovenian: LV-1013 Riga
English: Via G. Fabbroni 6 00191 Roma Italy
Slovenian: Via G. Fabbroni, 6 I-00191 Roma Italija
English: Box 581
Slovenian: Post Bus 581
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, PREDSTAVLJENI S STRANI EVROPSKE AGENCIJE ZA ZDRAVILA
English: Use of gastroprotective agents and low dose aspirin were permitted in the studies.
Slovenian: Uporaba gastroprotektivnih zdravil in majhnih odmerkov acetilsalicilne kisline je bila v raziskavi dovoljena.
English: 6.6 Special precautions for disposal No special requirements.
Slovenian: 6.6 Navodila za uporabo in ravnanje z zdravilom Ni posebnih zahtev.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS / MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK TER JAKOSTI ZDRAVILA, POT UPORABE IN IMETNIKOV DOVOLJENJA ZA PROMET V DRŽAVAH ČLANICAH TER NORVEŠKA IN ISLANDIJA
English: An increase in EE exposure can increase the incidence of adverse events associated with oral contraceptives (e.g., venous thrombo-embolic events in women at risk).
Slovenian: Povečana izpostavitev EE lahko poveča pojavnost neželenih učinkov, povezanih s peroralnimi kontraceptivi (npr. venske tromboembolije pri ženskah s tveganjem).
English: Estimated renal creatinine clearance <30 ml/min.
Slovenian: Kreatininski očistek ocenjen < 30 ml/min.
English: No dosage adjustment is necessary for elderly patients.
Slovenian: Starejši bolniki: Pri starejših bolnikih prilagajanje odmerkov ni potrebno.
English: NL-2003 PC Haarlem The Netherlands
Slovenian: 2003 PC Haarlem Nizozemska
English: Therefore antiplatelet therapies should not be discontinued (see sections above, 4.5 and 5.1.
Slovenian: Zato antiagregacijskega zdravljenja ne smemo ukiniti (glejte zgoraj in poglavji 4.5 in 5.1).
English: COX-2 is the isoform of the enzyme that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever.
Slovenian: COX-2 predstavlja izoobliko encima, za katero se je pokazalo, da jo inducirajo provnetni dražljaji in za katerega domnevajo, da je odgovoren predvsem za sintezo prostanoidnih mediatorjev bolečine, vnetja in vročine.
English: <Etoricoxib> is administered orally and may be taken with or without food.
Slovenian: < IZMIŠLJENO IME > je za peroralno uporabo in se lahko jemlje s hrano ali brez nje.
English: Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease.
Slovenian: Potrjena ishemična srčna bolezen, bolezen perifernih arterij in/ali cerebrovaskularna bolezen.
English: Laboratorios Abello, S.A. Josefa Valcárcel, 38 28027 Madrid Spain
Slovenian: Laboratorios Abelló S.A. Josefa Valcárcel 38 Madrid 28027
English: Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with etoricoxib after careful consideration (see section 5.1).
Slovenian: Bolnike s pomembnimi dejavniki tveganja srčno-žilnih dogodkov (npr. visok krvni tlak, hiperlipidemija, sladkorna bolezen, kajenje) lahko z etorikoksibom zdravimo le po skrbnem premisleku (glejte poglavje 5.1).
English: The effect of the recommended chronic doses of etoricoxib (30, 60, and 90 mg) has not been studied.
Slovenian: Učinka priporočenih odmerkov etorikoksiba za dolgotrajno zdravljenje (60 in 90 mg) niso preučili.
English: In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of an ACE inhibitor or Angiotensin II antagonist and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.
Slovenian: Pri nekaterih bolnikih z zmanjšano ledvično funkcijo (npr. dehidriranih bolnikih ali starejših bolnikih z zmanjšano ledvično funkcijo) lahko sočasno jemanje zaviralca ACE ali zaviralca receptorjev angiotenzina II in učinkovin, ki zavirajo ciklooksigenazo, povzroči nadaljnje poslabšanje ledvične funkcije, vključno z možno akutno ledvično odpovedjo, kar pa je ponavadi reverzibilno.
English: However no treatment-related external or skeletal foetal malformations were observed.
Slovenian: Pri kuncih niso opazili nobenih z zdravljenjem povezanih zunanjih ali skeletnih malformacij ploda.
English: For a full list of excipients, see section 6.1.
Slovenian: Za pomožne snovi glejte poglavje 6.1.
English: If a woman becomes pregnant during treatment, etoricoxib must be discontinued.
Slovenian: Če ženska zanosi tekom zdravljenja, je treba etorikoksib ukiniti.
English: Tablet coating: carnauba wax, lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin.
Slovenian: Obloga tablete: karnauba vosek, laktoza monohidrat, hipromeloza, titanov dioksid (E 171), gliceriltriacetat.
English: 60, 90 and 120 mg Aluminum/aluminium blisters in packs containing 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 or 100 tablets.
Slovenian: Aluminij/aluminij pretisni omoti v škatlah, ki vsebujejo 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 ali 100 tablet.
English: Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
Slovenian: Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov (glejte 6.1) v preteklosti.
English: <Etoricoxib> tablets contain lactose.
Slovenian: Tablete < IZMIŠLJENO IME > vsebujejo laktozo.
English: 00-867 Warsaw Poland
Slovenian: Puławska 303 02-785 Warszawa Poljska
English: The onset of the effect of the medicinal product may be faster when <Etoricoxib> is administered without food.
Slovenian: Učinek lahko nastopi hitreje, če < IZMIŠLJENO IME > vzamemo brez hrane.
English: The use of etoricoxib in patients with creatinine clearance <30 ml/min is contra-indicated (see sections 4.3 and
Slovenian: Uporaba etorikoksiba pri bolnikih s kreatininskim očistkom < 30 ml /min je kontraindicirana (glejte 4.3 in 4.4).
English: • You have a history of high blood pressure.
Slovenian: Pogoste: visok krvni tlak.
English: Very rare: hypersensitivity reactions, including angioedema, anaphylactic/anaphylactoid reactions including shock.
Slovenian: Zelo redke: preobčutljivostne reakcije, vključno z angioedemom, anafilaktičnimi/anafilaktoidnimi reakcijami.
English: Bottles: Keep the container tightly closed in order to protect from moisture.
Slovenian: Plastenke: Vsebnik shranjujte tesno zaprt.
English: As with other medicinal products known to inhibit prostaglandin synthesis, fluid retention, oedema and hypertension have been observed in patients taking etoricoxib.
Slovenian: Tako kot pri drugih zdravilih, ki zavirajo tvorbo prostaglandinov, so tudi pri bolnikih, ki so dobivali etorikoksib, opazili zadrževanje tekočine, edeme in hipertenzijo.
English: Av. da Siderurgia Nacional S. Mamede do Coronado Portugal
Slovenian: Av. Da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugalska
English: For the symptomatic relief of osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and the pain and signs of inflammation associated with acute gouty arthritis.
Slovenian: Simptomatsko lajšanje bolečine pri zdravljenju osteoartroze (OA), revmatoidnega artritisa (RA) ter bolečine in znakov vnetja, povezanih z akutnim uričnim artritisom.
English: Hertfordshire EN11 9B4 United Kingdom
Slovenian: Hertfordshire EN11 9BU Velika Britanija
English: In rats and rabbits, there was a dose dependent increase in post implantation loss at exposures greater than or equal to 1.5 times the human exposure (see sections 4.3 and 4.6).
Slovenian: Vendar pa se je preživetje zarodka/ploda zmanjšalo pri izpostavitvi, enaki ali večji od 1,5-kratne izpostavitve pri človeku (glejte 4.3 in 4.6).
English: Clinical trials suggest that the selective COX-2 inhibitor class of drugs may be associated with a risk of thrombotic events (especially myocardial infarction (MI) and stroke), relative to placebo and some NSAIDs.
Slovenian: Klinične raziskave kažejo, da je razred zdravil selektivnih zaviralcev COX-2 lahko povezan s tveganjem za trombotične dogodke (posebno za miokardni infarkt in možgansko kap) glede na placebo in nekatere NSAR-e.
English: The 30-, 60- and 120-mg tablets also contain indigo carmine lake (E132) and yellow ferric oxide (E172).
Slovenian: 60 mg in 120 mg tablete vsebujejo še indigo karmin (E 132) in rumeni železov oksid (E 172).
English: In clinical trials, etoricoxib was evaluated for safety in 7152 individuals, including 4614 patients with OA, RA, chronic low back pain or ankylosing spondylitis (approximately 600 patients with OA or RA were treated for one year or longer).
Slovenian: V kliničnih raziskavah so varnost etorikoksiba ovrednotili pri približno 4800 posameznikih, vključno s približno 3400 bolniki z OA, RA ali kronično bolečino v križu (približno 600 bolnikov z OA ali RA se je zdravilo eno leto ali več).
English: No dosage adjustment is necessary for patients with creatinine clearance ≥30 ml/min (see section 5.2).
Slovenian: Ledvična okvara: Pri bolnikih s kreatininskim očistkom ≥ 30 ml/min prilagajanje odmerkov ni potrebno (glejte 5.2).
English: Uncommon: atrial fibrillation, congestive heart failure, non-specific ECG changes, myocardial infarction
Slovenian: Srčne bolezni: Občasne: kongestivno srčno popuščanje, nespecifične spremembe EKG, miokardni infarkt
English: Hormone Replacement Therapy (HRT): Administration of etoricoxib 120 mg with hormone replacement therapy consisting of conjugated estrogens (0.625 mg PREMARINTM ) for 28 days, increased the mean steady state AUC0-24hr of unconjugated estrone (41%), equilin (76%), and 17-β-estradiol (22%).
Slovenian: Hormonsko nadomestno zdravljenje: Jemanje etorikoksiba 120 mg skupaj z 28-dnevnim hormonskim nadomestnim zdravljenjem, ki je vsebovalo konjugirane estrogene (0,625 mg zdravila PREMARIN™ <ali lokalna BLAGOVNA ZNAMKA>), je povečalo AUC0-24 ur v stanju dinamičnega ravnovesja pri nekonjugiranem estronu (41 %), ekvilinu (76 %) ter pri 17-β-estradiolu (22 %).
English: The effects of etoricoxib 120 mg on the exposure (AUC0-24hr) to these estrogenic components of PREMARIN were less than half of those observed when PREMARIN was administered alone and the dose was increased from 0.625 to 1.25 mg.
Slovenian: Učinki etorikoksiba 120 mg na izpostavitev (AUC0-24hr) tem estrogenskim sestavinam zdravila PREMARIN <ali lokalna BLAGOVNA ZNAMKA> so bili manj kot polovični v primerjavi z učinki pri jemanju samo zdravila PREMARIN <ali lokalna BLAGOVNA ZNAMKA>, če so odmerek povečali z 0,625 mg na 1,25 mg.
English: SUMMARY OF PRODUCT CHARACTERISTICS
Slovenian: EU POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
English: Tatoiou Street, Nea Erythrea 14671 Greece
Slovenian: 14671 Nea Erythrea Athens
English: Uncommon: flushing, cerebrovascular accident
Slovenian: Občasne: zardevanje, cerebrovaskularni dogodek*.
English: Regardless of indication, in patients with mild hepatic dysfunction (Child-Pugh score 5-6) a dose of 60 mg once daily should not be exceeded.
Slovenian: Jetrna okvara: Pri bolnikih z blago motnjo delovanja jeter (lestvica po Child-Pughu 5-6) ne smemo prekoračiti odmerka 60 mg enkrat na dan.
English: The following undesirable effects were reported at an incidence greater than placebo in clinical trials in patients with OA, RA, chronic low back pain or ankylosing spondylitis treated with etoricoxib 30 mg, 60 mg or 90 mg for up to 12 weeks, or in the MEDAL Program studies, or in post-marketing experience:
Slovenian: O naslednjih neželenih učinkih, katerih pojavnost je bila večja kot pri placebu, so poročali v kliničnih raziskavah pri bolnikih z OA, RA ali kronično bolečino v križu, ki so se z etorikoksibom v odmerkih 60 mg ali 90 mg zdravili do 12 tednov:
English: Across clinical pharmacology studies, <Etoricoxib> produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily.
Slovenian: V kliničnih farmakoloških raziskavah je imela < IZMIŠLJENO IME > v odmerkih do 150 mg dnevno od odmerka odvisen zaviralni učinek na COX-2, ne da bi zavirala COX-1.
English: PHARMACEUTICAL FORM Film-coated tablet (tablet).
Slovenian: Filmsko obložena tableta.
English: Oral contraceptives: Etoricoxib 60 mg given concomitantly with an oral contraceptive containing 35 micrograms ethinyl estradiol (EE) and 0.5 to 1 mg norethindrone for 21 days increased the steady state AUC0-24hr of EE by 37%.
Slovenian: Peroralni kontraceptivi: 21 dnevna uporaba etorikoksiba v odmerku 60 mg skupaj s peroralnim kontraceptivom, ki vsebuje 35 µg etinilestradiola (EE) in 0,5 do 1 mg noretindrona, je povečala AUC024 ur EE v stanju dinamičnega ravnovesja za 37 %.
English: There was no discernible difference in the rate of confirmed serious thrombotic cardiovascular events between patients receiving etoricoxib ≥60 mg, placebo, or nonnaproxen NSAIDs.
Slovenian: Deleži resnih trombotičnih srčno-žilnih zapletov se pri bolnikih, ki so dobivali etorikoksib ≥ 60 mg, placebo ali NSAR-e, razen naproksena, niso opazno razlikovali.
English: Merck Sharp & Dohme BV.
Slovenian: Merck Sharp & Dohme B.V.
English: Safety and effectiveness of etoricoxib in paediatric patients have not been established (see section
Slovenian: Varnosti in učinkovitosti etorikoksiba pri pediatričnih bolnikih niso ugotavljali.
English: United Kingdom Merck Sharpe & Dohme Limited, Hertford Road
Slovenian: Velika Britanija Merck Sharp & Dohme Limited Hertford Road
English: The dose for RA and ankylosing spondylitis should not exceed 90 mg daily The dose for acute gout should not exceed 120 mg daily, limited to a maximum of 8 days treatment.
Slovenian: Odmerek za akutni urični artritis ne sme preseči 120 mg na dan in mora biti omejen na največ 8 dni zdravljenja.
English: In this leaflet:
Slovenian: po vrednotenju:
English: Etoricoxib
Slovenian: Etoricoxib MSD
English: Laboratórios Bial - Portela & Cª, S.A. PRT
Slovenian: Bial-Portela & Ca., S.A.
English: Immune system disorder:
Slovenian: Bolezni imunskega sistema:
English: In clinical studies excluding the MEDAL Program Studies, approximately 3100 patients were treated with etoricoxib ≥60 mg daily for 12 weeks or longer.
Slovenian: Približno 3100 bolnikov so zdravili z etorikoksibom ≥ 60 mg dnevno 12 tednov ali več.
English: Each film coated tablet contains 30, 60, 90 or 120 mg of etoricoxib.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 60 mg, 90 mg ali 120 mg etorikoksiba.
English: <Etoricoxib> Tablets should not be taken by children or adolescents under 16 years of age.
Slovenian: Pediatrični bolniki: Etorikoksib je kontraindiciran pri otrocih in mladostnikih, mlajših od 16 let.
English: Merck Sharp & Dohme Magyarország Kft. Alkotás utca 50
Slovenian: MSD Hungary Ltd. Alkotás utca 50
English: 30 mg:
Slovenian: 120 mg tablete:
English: NSAIDs + acetylsalicylic acid has not been demonstrated in long-term clinical trials (see section 5.1).
Slovenian: Pomembne razlike v varnosti za prebavila med zdravljenjem s selektivnimi COX-2 zaviralci in acetilsalicilno kislino ter zdravljenjem z NSAR-i in acetilsalicilno kislino v dolgoročnih kliničnih raziskavah niso dokazali (glejte poglavje 5.1).