natgillin/translations-raw huggingface dataset:
By blocking the tyrosine kinase in EGFR, rociletinib is expected to help reduce the growth and spread of the cancer. 
Rociletinib naj bi z zaviranjem tirozin-kinaze v EGFR pripomogel k zmanjšani rasti in širjenju raka.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Xegafri did not outweigh its risks. 
Zato je odbor CHMP v času umika menil, da koristi zdravila Xegafri ne odtehtajo z njim povezanih tveganj.
Withdrawal of the marketing authorisation application for Xegafri (rociletinib) 
Umik vloge za pridobitev dovoljenja za promet z zdravilom Xegafri (rociletinib)
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. 
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.
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. 
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.
The active substance in Xegafri, rociletinib, is a tyrosine kinase inhibitor. 
Zdravilna učinkovina v zdravilu Xegafri, rociletinib, je zaviralec tirozin-kinaze.
How is Xegafri expected to work? 
Kako naj bi zdravilo Xegafri delovalo?
1 ml (100 mg/ml) 2 (2 x 1) pre-filled syringes (multipack) 
2 (2 x 1) napolnjeni injekcijski brizgi (večje pakiranje)
1 ml (100 mg/ml) 1 pre-filled syringe 
1 napolnjen injekcijski peresnik napolnjena injekcijska brizga (steklo) v napolnjenem injekcijskem peresniku
2 pre-filled syringes + 2 safety needles 
2 napolnjeni injekcijski brizgi + 2 varnostni igli
1 pre-filled syringe + 1 safety needle 
1 napolnjena injekcijska brizga + 1 varnostna igla
Invented name Strength Pharmaceutical Form 
številka EU izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina velikost pakiranja
3 years. 
2 leti.
1123 Budapest Hungary 
H-1123 Budapest Madžarska
1000 Ljubljana Slovenia 
SI-1000 Ljubljana Slovenija
[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)] 
[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)]
Via Benedetto Croce, 37 56125 Pisa 
Via Benedetto Croce, 37 I-56125 Pisa Italija
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. 
Kaže, da je tveganje za te reakcije največje kmalu po začetku zdravljenja, v večini primerov z nastopom v prvem mesecu zdravljenja.
Very rare: hypertensive crisis. 
Zelo redke:hipertenzivna kriza.
Via G. Fabbroni 6 00191 Roma Italy 
Via G. Fabbroni, 6 I-00191 Roma Italija
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET PRESENTED BY THE EMEA 
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, PREDSTAVLJENI S STRANI EVROPSKE AGENCIJE ZA ZDRAVILA
Use of gastroprotective agents and low dose aspirin were permitted in the studies. 
Uporaba gastroprotektivnih zdravil in majhnih odmerkov acetilsalicilne kisline je bila v raziskavi dovoljena.
6.6 Special precautions for disposal No special requirements. 
6.6 Navodila za uporabo in ravnanje z zdravilom Ni posebnih zahtev.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS / MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES 
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK TER JAKOSTI ZDRAVILA, POT UPORABE IN IMETNIKOV DOVOLJENJA ZA PROMET V DRŽAVAH ČLANICAH TER NORVEŠKA IN ISLANDIJA
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). 
Povečana izpostavitev EE lahko poveča pojavnost neželenih učinkov, povezanih s peroralnimi kontraceptivi (npr. venske tromboembolije pri ženskah s tveganjem).
Estimated renal creatinine clearance <30 ml/min. 
Kreatininski očistek ocenjen < 30 ml/min.
No dosage adjustment is necessary for elderly patients. 
Starejši bolniki: Pri starejših bolnikih prilagajanje odmerkov ni potrebno.
NL-2003 PC Haarlem The Netherlands 
2003 PC Haarlem Nizozemska
Therefore antiplatelet therapies should not be discontinued (see sections above, 4.5 and 5.1. 
Zato antiagregacijskega zdravljenja ne smemo ukiniti (glejte zgoraj in poglavji 4.5 in 5.1).
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. 
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.
<Etoricoxib> is administered orally and may be taken with or without food. 
< IZMIŠLJENO IME > je za peroralno uporabo in se lahko jemlje s hrano ali brez nje.
Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease. 
Potrjena ishemična srčna bolezen, bolezen perifernih arterij in/ali cerebrovaskularna bolezen.
Laboratorios Abello, S.A. Josefa Valcárcel, 38 28027 Madrid Spain 
Laboratorios Abelló S.A. Josefa Valcárcel 38 Madrid 28027
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). 
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).
The effect of the recommended chronic doses of etoricoxib (30, 60, and 90 mg) has not been studied. 
Učinka priporočenih odmerkov etorikoksiba za dolgotrajno zdravljenje (60 in 90 mg) niso preučili.
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. 
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.
However no treatment-related external or skeletal foetal malformations were observed. 
Pri kuncih niso opazili nobenih z zdravljenjem povezanih zunanjih ali skeletnih malformacij ploda.
For a full list of excipients, see section 6.1. 
Za pomožne snovi glejte poglavje 6.1.
If a woman becomes pregnant during treatment, etoricoxib must be discontinued. 
Če ženska zanosi tekom zdravljenja, je treba etorikoksib ukiniti.
Tablet coating: carnauba wax, lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin. 
Obloga tablete: karnauba vosek, laktoza monohidrat, hipromeloza, titanov dioksid (E 171), gliceriltriacetat.
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. 
Aluminij/aluminij pretisni omoti v škatlah, ki vsebujejo 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 ali 100 tablet.
Hypersensitivity to the active substance or to any of the excipients (see section 6.1). 
Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov (glejte 6.1) v preteklosti.
<Etoricoxib> tablets contain lactose. 
Tablete < IZMIŠLJENO IME > vsebujejo laktozo.
00-867 Warsaw Poland 
Puławska 303 02-785 Warszawa Poljska
The onset of the effect of the medicinal product may be faster when <Etoricoxib> is administered without food. 
Učinek lahko nastopi hitreje, če < IZMIŠLJENO IME > vzamemo brez hrane.
The use of etoricoxib in patients with creatinine clearance <30 ml/min is contra-indicated (see sections 4.3 and 
Uporaba etorikoksiba pri bolnikih s kreatininskim očistkom < 30 ml /min je kontraindicirana (glejte 4.3 in 4.4).
• You have a history of high blood pressure. 
Pogoste: visok krvni tlak.
Very rare: hypersensitivity reactions, including angioedema, anaphylactic/anaphylactoid reactions including shock. 
Zelo redke: preobčutljivostne reakcije, vključno z angioedemom, anafilaktičnimi/anafilaktoidnimi reakcijami.
Bottles: Keep the container tightly closed in order to protect from moisture. 
Plastenke: Vsebnik shranjujte tesno zaprt.
As with other medicinal products known to inhibit prostaglandin synthesis, fluid retention, oedema and hypertension have been observed in patients taking etoricoxib. 
Tako kot pri drugih zdravilih, ki zavirajo tvorbo prostaglandinov, so tudi pri bolnikih, ki so dobivali etorikoksib, opazili zadrževanje tekočine, edeme in hipertenzijo.
Av. da Siderurgia Nacional S. Mamede do Coronado Portugal 
Av. Da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugalska
For the symptomatic relief of osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and the pain and signs of inflammation associated with acute gouty arthritis. 
Simptomatsko lajšanje bolečine pri zdravljenju osteoartroze (OA), revmatoidnega artritisa (RA) ter bolečine in znakov vnetja, povezanih z akutnim uričnim artritisom.
Hertfordshire EN11 9B4 United Kingdom 
Hertfordshire EN11 9BU Velika Britanija
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). 
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).
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. 
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.
The 30-, 60- and 120-mg tablets also contain indigo carmine lake (E132) and yellow ferric oxide (E172). 
60 mg in 120 mg tablete vsebujejo še indigo karmin (E 132) in rumeni železov oksid (E 172).
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). 
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).
No dosage adjustment is necessary for patients with creatinine clearance ≥30 ml/min (see section 5.2). 
Ledvična okvara: Pri bolnikih s kreatininskim očistkom ≥ 30 ml/min prilagajanje odmerkov ni potrebno (glejte 5.2).
Uncommon: atrial fibrillation, congestive heart failure, non-specific ECG changes, myocardial infarction 
Srčne bolezni: Občasne: kongestivno srčno popuščanje, nespecifične spremembe EKG, miokardni infarkt
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%). 
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 %).
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. 
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.
SUMMARY OF PRODUCT CHARACTERISTICS 
EU POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
Tatoiou Street, Nea Erythrea 14671 Greece 
14671 Nea Erythrea Athens
Uncommon: flushing, cerebrovascular accident 
Občasne: zardevanje, cerebrovaskularni dogodek*.
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. 
Jetrna okvara: Pri bolnikih z blago motnjo delovanja jeter (lestvica po Child-Pughu 5-6) ne smemo prekoračiti odmerka 60 mg enkrat na dan.
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: 
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:
Across clinical pharmacology studies, <Etoricoxib> produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily. 
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.
PHARMACEUTICAL FORM Film-coated tablet (tablet). 
Filmsko obložena tableta.
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%. 
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 %.
There was no discernible difference in the rate of confirmed serious thrombotic cardiovascular events between patients receiving etoricoxib ≥60 mg, placebo, or nonnaproxen NSAIDs. 
Deleži resnih trombotičnih srčno-žilnih zapletov se pri bolnikih, ki so dobivali etorikoksib ≥ 60 mg, placebo ali NSAR-e, razen naproksena, niso opazno razlikovali.
Safety and effectiveness of etoricoxib in paediatric patients have not been established (see section 
Varnosti in učinkovitosti etorikoksiba pri pediatričnih bolnikih niso ugotavljali.
United Kingdom Merck Sharpe & Dohme Limited, Hertford Road 
Velika Britanija Merck Sharp & Dohme Limited Hertford Road
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. 
Odmerek za akutni urični artritis ne sme preseči 120 mg na dan in mora biti omejen na največ 8 dni zdravljenja.
In this leaflet: 
po vrednotenju:
Etoricoxib 
Etoricoxib MSD
Immune system disorder: 
Bolezni imunskega sistema:
In clinical studies excluding the MEDAL Program Studies, approximately 3100 patients were treated with etoricoxib ≥60 mg daily for 12 weeks or longer. 
Približno 3100 bolnikov so zdravili z etorikoksibom ≥ 60 mg dnevno 12 tednov ali več.
Each film coated tablet contains 30, 60, 90 or 120 mg of etoricoxib. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 60 mg, 90 mg ali 120 mg etorikoksiba.
<Etoricoxib> Tablets should not be taken by children or adolescents under 16 years of age. 
Pediatrični bolniki: Etorikoksib je kontraindiciran pri otrocih in mladostnikih, mlajših od 16 let.
Merck Sharp & Dohme Magyarország Kft. Alkotás utca 50 
MSD Hungary Ltd. Alkotás utca 50
30 mg: 
120 mg tablete:
NSAIDs + acetylsalicylic acid has not been demonstrated in long-term clinical trials (see section 5.1). 
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).
Uncommon: abdominal distention, acid reflux, bowel movement pattern change, constipation, dry mouth, gastroduodenal ulcer, irritable bowel syndrome, oesophagitis, oral ulcer, vomiting, gastritis. 
Občasne: napihnjen trebuh, refluks kisline, spremenjen vzorec iztrebljanja, zaprtje, suha usta, razjeda želodca in dvanajstnika, sindrom iritabilnega kolona, ezofagitis, razjeda v ustih, bruhanje.
Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids, coxibs, ATC Code: M01 AH05 
Farmakoterapevtska skupina: Nesteroidni protivnetni in protirevmatični pripravki, koksibi
The recommended dose is 30 mg once daily. 
Osteoartroza Priporočeni odmerek je 60 mg enkrat na dan.
The clinical significance of these increases is unknown, and higher doses of PREMARIN were not studied in combination with etoricoxib. 
Večjih odmerkov zdravila PREMARIN <ali lokalna BLAGOVNA ZNAMKA> v kombinaciji z etorikoksibom niso preučili.
Eye disorders: Uncommon: blurred vision, conjunctivitis. 
Očesne bolezni: Občasne: zamegljen vid.
<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] 
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
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. 
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).
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. 
Zato mora biti med zdravljenjem z etorikoksibom posebna pozornost namenjena kontroli krvnega tlaka.
Efficacy 
Jakost
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. 
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.
Patients with hypertension whose blood pressure is persistently elevated above 140/90mmHg and has not been adequately controlled. 
Bolniki z visokim krvnim tlakom, ki ni zadostno nadzorovan.
National competent authorities (NCA) shall ensure that the following conditions are fulfilled by the marketing authorisation holders: 
Pristojne oblasti držav članic bodo podatke o izdelku posodobile v skladu z zahtevami, ko bo podana odločba Komisije.
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) 
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
Belgium Merck Sharp and Dohme Chaussée de Waterloo 1135 
Merck Sharp&Dohme s.a. 1180, Chaussée de Waterloo B-1135 Bruxelles Belgija
- 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. 
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.
Per-protocol 
Peroralna uporaba
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. 
Bele, okrogle HDPE plastenke z belim polipropilenskim zamaškom s 30 ali 90 tabletami.
PHARMACEUTICAL FORM AND CONTENTS 
FARMACEVTSKA OBLIKA
Skanstes 13 
DODATEK III
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. 
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.
Rate 
Opis
Addenda Pharma S.r.l Viale Shakespeare, 47 00144 Roma Italy 
Via dei Santi Pietro e Paolo, 30 00144 Roma Italija
Merck Sharp and Dohme Ltd Hertford Road 
Merck Sharp & Dohme Limited Hertford Road
- A direct healthcare professional communication (DHPC) must be sent to all healthcare professionals who prescribe etoricoxib according to national practice. 
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.
90 mg white, apple-shaped, biconvex film coated tablets marked ‘ARCOXIA 90' on one side and ‘202' on the other. 
90 mg tablete: Bele, bikonveksne tablete v obliki jabolka, z oznako "454" na eni strani ter "MSD" na drugi strani.
Uncommon: facial oedema, pruritus, rash. 
Občasne: ekhimoza, edemi obraza, pruritus, izpuščaj.
NAME OF THE MEDICINAL PRODUCT 
Država članica Imetnik dovoljenja za promet z zdravilom