natgillin/translations-raw huggingface dataset:
Crossover patients received up to 46 months of mogamulizumab therapy, as of December 2016 data cut. 
Po podatkih, zbranih do decembra 2016, so se bolniki, ki so zamenjali zdravilo, zdravili z mogamulizumabom največ 46 mesecev.
POTELIGEO is a clear to slightly opalescent, colourless solution. 
POTELIGEO je bistra do rahlo opalescentna brezbarvna raztopina.
The effects of various covariates on the PK s of mogamulizumab were assessed in population PK analyses. 
V analizah populacijske farmakokinetike so ocenili učinke različnih kovariatov na farmakokinetiko mogamulizumaba.
Patients receiving POTELIGEO have experienced drug rash (drug eruption), some of which were severe and/or serious. 
Pri bolnikih, ki so prejemali zdravilo POTELIGEO, se je pojavil medikamentozni izpuščaj (kožna reakcija na zdravilo); nekateri primeri so bili hudi in/ali resni.
POTELIGEO contains sodium 
OVOJNINAH NALEPKA NA VIALI
No adverse effects on male and female reproductive organs were observed in repeat-dose toxicity studies in cynomolgus monkeys (see section 5.3). 
V študijah toksičnosti ponavljajočih se odmerkov, ki so jih opravili na opicah pasme Macaca fascicularis, niso ugotovili neželenih učinkov na reproduktivne organe samcev in samic (glejte poglavje 5.3).
For patients who test positive for current/previous hepatitis B infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended for advice concerning appropriate measures against hepatitis B reactivation. 
Bolnike je treba pred začetkom zdravljenja z mogamulizumabom testirati za okužbo z virusom hepatitisa B. Bolnikom s pozitivnim testom za sedanjo/preteklo okužbo s hepatitisom B se priporoča, da se posvetujejo z zdravnikom, ki ima strokovno znanje o zdravljenju hepatitisa B, glede ustreznih ukrepov za preprečevanje ponovne aktivacije hepatitisa B. Zapleti pri alogenski presaditvi hematopoetskih matičnih celic (HSCT) po zdravljenju z mogamulizumabom Pri bolnikih s T-celičnimi limfomi, razen FM ali SS, pri katerih so po zdravljenju z mogamulizumabom opravili presaditev hematopoetskih matičnih celic (HSCT), so poročali o zapletih,
Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi citronska kislina monohidrat glicin polisorbat 80 natrijev hidroksid (za prilagoditev vrednosti pH) klorovodikova kislina (za prilagoditev vrednosti pH) voda za injekcije
Very common Headache 
Bolezni živčevja zelo pogosti glavobol
Injury, poisoning and procedural complications 
Poškodbe, zastrupitve in zapleti pri posegih zelo pogosti reakcija, povezana z infundiranjem
Anaemia, neutropenia, leukopenia, Thrombocytopenia 
Bolezni krvi in limfatičnega sistema pogosti anemija, nevtropenija, levkopenija, trombocitopenija
The majority of IRRs occur during or shortly after the first infusion (all within 24 hours of administration), with the incidence decreasing over subsequent treatments. 
(v 24 urah po dajanju zdravila), nato pa se pojavnost pri nadaljnjih krogih zdravljenja zmanjšuje.
- fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness and/or muscle or joint pain. 
epileptični napadi, neenakomeren srčni utrip, temen ali moten urin, nenavadna utrujenost in/ali bolečine v mišicah ali sklepih.
See section 4.2 for dose modification information. 
Informacije o prilagoditvah odmerjanja so v poglavju 4.2.
Overall response rate (confirmed CR + PR, %) 95% CI P-valuea Viscera n=6 
Skupna stopnja odziva (potrjen CR + PR, %) 95-odstotni IZ Vrednost Pa Drobovje n = 6
Overall response rate (confirmed CR + PR, %) 
Skupna stopnja odziva (potrjen PO + DO, %)
No clinically important differences in the clearance of mogamulizumab were found between patients with mild to severe renal impairment and patients with normal renal function. 
Med bolniki z blago do hudo okvaro ledvic in bolniki z normalnim delovanjem ledvic ni bilo klinično pomembnih razlik v očistku mogamulizumaba.
No clinically important differences in the clearance of mogamulizumab were found between patients with mild to moderate hepatic impairment and patients with normal hepatic function. 
Med bolniki z blago do zmerno okvaro jeter in bolniki z normalnim delovanjem jeter niso ugotovili klinično pomembnih razlik v očistku mogamulizumaba.
Of the patients randomised to vorinostat, 136 patients (73.1%) crossed over to mogamulizumab during the study. 
Med bolniki, ki so bili naključno razvrščeni v skupino z vorinostatom, je med študijo 136 bolnikov
Warnings and precautions Talk to your doctor or nurse before using POTELIGEO if you: 
Pred začetkom uporabe zdravila POTELIGEO se posvetujte z zdravnikom ali medicinsko sestro:
Overall response rate (confirmed CR + PR, %) 95% CI P-valuea Lymph nodes n=136 
Skupna stopnja odziva (potrjen PO + DO, %) 95-odstotni IZ Vrednost Pa Bezgavke n = 136
- signs of infection, which may include a fever, sweats or chills, flu-like symptoms, sore throat or difficulty swallowing, cough, shortness of breath, stomach pain, nausea or vomiting, diarrhoea and feeling very unwell. 
Zdravnik lahko ukine vaše zdravljenje z zdravilom POTELIGEO, če imate hudo reakcijo nanj; - znaki okužbe, ki lahko vključujejo zvišano telesno temperaturo, znojenje ali mrazenje, gripi podobne simptome, vneto grlo ali težave pri požiranju, kašelj, zasoplost, bolečine v želodcu, siljenje na bruhanje ali bruhanje, drisko in zelo slabo počutje; - kožne bolečine, srbenje, mehurji na koži, kožni izpuščaj ali bolečina v ustih, ki so morda znaki,
POTELIGEO should be administered within 2 days of the scheduled day. 
Dajanje zdravila POTELIGEO sme odstopati od načrtovanega dneva za največ dva dni.
• Visually inspect the medicinal product for particulate matter and discolouration prior to administration. 
• Pred uporabo raztopino preverite ter se prepričajte, da ne vsebuje delcev in ni obarvana.
Acute infusion-related reactions (IRRs) have been observed in patients treated with mogamulizumab. 
Pri bolnikih, zdravljenih z mogamulizumabom, so opazili akutne reakcije, povezane z infundiranjem.
Less than 1% of patients treated in Study 0761-010 discontinued treatment due to infusion-related reactions. 
Zaradi reakcij, povezanih z infundiranjem, se je prenehalo zdraviti manj kot 1 % bolnikov v študiji
- chills, nausea or vomiting, headache, wheezing, itching, flushing, rash, dizziness or feeling faint, difficulty breathing and fever, which may be signs of an infusion reaction. 
omotica ali občutek, da boste omedleli, oteženo dihanje in zvišana telesna temperatura, ki so lahko znaki reakcije na infuzijo.
- skin pain, itching, skin blisters, skin rash or sore mouth, which are possible signs that you may be developing a severe skin reaction, such as Stevens-Johnson syndrome or toxic epidermal necrolysis. 
da se razvija huda kožna reakcija, kot sta Stevens-Johnsonov sindrom ali toksična epidermalna nekroliza;
• POTELIGEO should be permanently discontinued for a life-threatening (Grade 4) rash (see section 4.4). 
POTELIGEO trajno opustiti (glejte poglavje 4.4).
Polysorbate 80 
Bloemlaan 2
Clear to slightly opalescent, colourless solution. 
POTELIGEO je bistra brezbarvna raztopina.
Endocrine disorders 
Organski sistem
Uncommon Tumour lysis syndrome 
Presnovne in prehranske motnje občasni sindrom tumorske lize
- ever had an infusion reaction with this medicine (possible symptoms of an infusion reaction are listed in section 4). 
- če ste kdaj imeli hudo kožno reakcijo na to zdravilo; - če ste kdaj imeli reakcijo na infuzijo tega zdravila (možni simptomi reakcije, povezane z infuzijo, so navedeni v poglavju 4); - če imate virus humane imunske pomanjkljivosti (HIV), herpes, citomegalovirus (CMV), okužbo s hepatitisom B ali C ali drugo okužbo, ki se še ni pozdravila;
Blood and lymphatic system disorders 
Bolezni endokrinega sistema pogosti hipotiroidizem
• If you have any questions, speak with your doctor or pharmacist. 
• Če imate kakršna koli vprašanja, se posvetujte z zdravnikom ali farmacevtom.
It is currently available in the European Union (EU) in a number of different formulations. 
Trenutno je v Evropski uniji (EU) na voljo v več različnih farmacevtskih oblikah.
The review of systemic diclofenac was initiated on 31 October 2012 at the request of the United Kingdom medicines agency, under Article 31 of Directive 2001/83/EC. 
Pregled sistemskega diklofenaka se je začel dne 31. oktobra 2012 na zahtevo agencije Združenega kraljestva za zdravila v skladu s členom 31 Direktive 2001/83/ES.
• You should not stop taking your treatment without talking to your doctor. 
• Zdravila ne smete prenehati jemati, ne da bi se prej posvetovali z zdravnikom.
Limitations in the data had made it hard to quantify the risk initially, but a consistent picture was emerging by the time of the 2012 review. 
Zaradi pomanjkljivosti podatkov je bilo najprej težko kvantificirati tveganje, vendar se je do pregleda leta 2012 že pojavila dosledna slika.
The product information will be amended and healthcare professionals prescribing or dispensing systemic diclofenac will receive further appropriate communication at a national level. 
Informacije o zdravilu bodo spremenjene, zdravstveni delavci, ki predpisujejo ali izdajajo sistemski diklofenak, pa bodo prejeli dodatna ustrezna obvestila na nacionalni ravni.
The safety of NSAIDs has been closely monitored by regulatory authorities in the EU. 
Varnost teh zdravil podrobno spremljajo regulativni organi v EU.
New measures aim to minimise cardiovascular risks 
Novi ukrepi so namenjeni zmanjšanju srčno-žilnih tveganj
The latter found that, compared with placebo, the risk of major vascular events was increased by about one third by a COX-2 inhibitor (rate ratio [RR] 1.37, 95% confidence interval [CI] 1.14-1.66; p=0.0009) or diclofenac (1.41, 1.12-1.78; p=0.0036), mainly due to an increase in major coronary events (coxibs: 1.76, 1.312.37; p=0.0001; diclofenac: 1.70, 1.19-2.41; p=0.0032). 
V tej analizi so ugotovili, da se je v primerjavi s placebom tveganje za večje vaskularne dogodke povečalo za približno eno tretjino pri uporabi zaviralca COX-2 (razmerje stopnje [RS] 1,37, 95-odstotni interval zaupanja [IZ] 1,14-1,66; p = 0,0009) ali diklofenaka (1,41, 1,12-1,78; p = 0,0036), v glavnem zaradi povečanja števila večjih koronarnih dogodkov (koksibi: 1,76, 1,31-2,37; p = 0,0001; diklofenak: 1,70, 1,19-2,41; p = 0,0032).
Diclofenac-containing medicines have been authorised by national approval procedures in the EU Member States and have been available for many years under a wide range of trade names. 
Zdravila, ki vsebujejo diklofenak, so bila v državah članicah EU odobrena po nacionalnih postopkih in so že več let na voljo pod vrsto različnih trgovskih imen.
This applies particularly when diclofenac is used at a high dose and for long-term treatment. 
To velja predvsem, kadar se diklofenak uporablja pri velikih odmerkih za dolgoročno zdravljenje.
About 8 people in 1,000 at moderate risk of heart disease are likely to have a heart attack over one year. 
Približno 8 od 1.000 ljudi, pri katerih obstaja zmerno tveganje za bolezen srca, utegne utrpeti možgansko kap v obdobju enega leta.
• The effectiveness of diclofenac is well established. 
• Učinkovitost diklofenaka je bila dokazana.
As diclofenac-containing medicines are all authorised nationally, the PRAC recommendations were sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position. 
Ker so vsa zdravila, ki vsebujejo diklofenak, odobrena na nacionalni ravni, so bila priporočila odbora PRAC posredovana Usklajevalni skupini za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh), ki je sprejela dokončno stališče.
New safety advice for diclofenac 
Nova priporočila za varno uporabo diklofenaka
It belongs to a group of medicines called ‘non-steroidal anti-inflammatory drugs' (NSAIDs). 
Spada v skupino zdravil, imenovanih nesteroidna protivnetna zdravila (NSAID).
The latest review by the PRAC was therefore initiated specifically to assess the benefit-risk of systemic diclofenac. 
Zadnji pregled, ki ga je opravil odbor PRAC, se je torej začel posebej za to, da se oceni razmerje med tveganji in koristmi sistemskega diklofenaka.
The CMDh position was sent to the European Commission, which confirmed it and took a final legally binding decision throughout the EU on 25 September 2013. 
Stališče skupine CMDh je bilo posredovano Evropski komisiji, ki ga je potrdila in dne 25. septembra 2013 sprejela končen pravno zavezujoč sklep, veljaven po vsej EU.
• If you are on long-term diclofenac treatment you will need to have your treatment reviewed to ensure that it is still right for you. 
• Če vam je bilo predpisano dolgoročno zdravljenje z diklofenakom, bo treba ponovno oceniti zdravljenje in se prepričati, ali je to še vedno primerno za vas.
Diclofenac is effective in reducing inflammation and pain. 
Diklofenak je učinkovit pri zmanjšanju vnetja in bolečine.
Overall, compared with placebo, allocation to diclofenac or a coxib caused around three additional major vascular events per 1,000 participants per year, with one such event causing death; in high-risk individuals, about seven or eight more would have a major vascular event, of which two would be fatal. 
Na splošno sta diklofenak ali koksib v primerjavi s placebom povzročila približno tri dodatne večje vaskularne dogodke na 1.000 sodelujočih posameznikov na leto, pri čemer se je eden od teh dogodkov končal s smrtjo; med populacijo z velikim tveganjem bi bilo sedem ali osem posameznikov več z večjim vaskularnim dogodkom, od katerih bi bila dva smrtna.
Since some prostaglandins are involved in causing pain and inflammation at sites of injury or damage in the body, a reduced production of prostaglandins reduces pain and inflammation. 
Ker nekateri prostaglandini sodelujejo pri povzročanju bolečine in vnetja na mestih poškodb ali okvar v telesu, se z zmanjšanjem nastajanja prostaglandinov zmanjšata tudi bolečina in vnetje.
The overall number of heart attacks in people at moderate risk would be expected to increase by around 3 cases per year for every 1,000 people treated with diclofenac (to 11 per 1,000 people per year). 
Skupno število srčnih kapi pri ljudeh, pri katerih obstaja zmerno tveganje, bi se verjetno povečalo za približno 3 primere na leto za vsakih 1.000 ljudi, zdravljenih z diklofenakom (na 11 od 1.000 ljudi na leto).
A class warning of this risk is in place and the product information for all NSAIDs recommends that these medicines be used at the lowest effective dose for the shortest period of time necessary to control symptoms. 
Za to skupino je bilo izdano opozorilo o omenjenem tveganju, informacije o zdravilu za vsa nesteroidna protivnetna zdravila pa vsebujejo priporočilo, naj se ta zdravila uporabljajo pri najmanjšem učinkovitem odmerku in najkrajši možni čas, ki je potreben za obvladanje simptomov.
As the CMDh position was adopted by majority it was sent to the European Commission, which confirmed it and took a final legally binding decision valid throughout the EU. 
Ker je skupina CMDh omenjeno stališče sprejela z večino, je bilo posredovano Evropski komisiji, ki ga je potrdila in sprejela končen pravno zavezujoč sklep, veljaven po vsej EU.
Although the risk is likely to be dose-dependent, the PRAC considered that cardiovascular thrombotic risk cannot be excluded across all doses of diclofenac, especially in patients with pre-existing co-morbidities. 
Čeprav je tveganje verjetno odvisno od odmerka, je PRAC menil, da srčno-žilnega trombotičnega tveganja ni mogoče izključiti za vse odmerke diklofenaka, zlasti ne pri bolnikih s predhodno obstoječimi sočasnimi obolenji.
• As the cardiovascular risks of diclofenac may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. 
• Ker se srčno-žilna tveganja, povezana z diklofenakom, povečujejo z odmerkom in trajanjem izpostavljenosti, je treba diklofenak uporabljati čim krajši čas in pri najmanjšem učinkovitem dnevnem odmerku.
• If you have other risk factors such as high blood pressure, high blood cholesterol, diabetes, or if you smoke, your doctor will need to assess if you should use diclofenac and the best way to take it. 
• Če imate druge dejavnike tveganja, kot so visok krvni tlak, visoke ravni holesterola v krvi in sladkorna bolezen, ali če kadite, bo zdravnik moral oceniti, ali lahko uporabljate diklofenak in na kakšen način.
The new advice aims to minimise the risks of effects on the heart and circulation from these medicines. 
Z novimi priporočili se želi zmanjšati tveganja, povezana z učinki, ki jih imajo ta zdravila na srce in ožilje.
The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically. 
Občasno je treba ponovno oceniti potrebo bolnika po lajšanju simptomov in njegov odziv na zdravljenje.
• The risk with diclofenac is increased more if you are already at higher risk, so use is no longer recommended if you have already had a heart attack or stroke, or have heart failure, blockages to blood vessels to the heart or brain or an operation to clear or bypass such blockages, or circulatory problems that restrict blood flow to your limbs. 
• Tveganje pri uporabi diklofenaka se še poveča, če ste že izpostavljeni večjemu tveganju, zato se uporaba ne priporoča, če ste kdaj imeli srčno ali možgansko kap, če imate srčno popuščanje ali zamašene krvne žile, ki oskrbujejo srce ali možgane, če ste imeli operacijo za sprostitev ali premostitev zamašenih žil ali če imate težave z ožiljem, ki ovirajo dotok krvi v ude.
On 28 June 2013, the Co-ordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMDh) endorsed by majority new safety advice for diclofenac-containing medicines that are given by means such as capsules, tablets, suppositories or injections, intended to have an effect on the whole body (known as a systemic effect). 
Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh) je dne 28. junija 2013 z večino podprla nova priporočila za varno uporabo zdravil, ki vsebujejo diklofenak in se dajejo na primer v obliki kapsul, tablet, svečk ali injekcij, ki naj bi učinkovale na celotno telo (t. i. sistemski učinek).
Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials. 
Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials (Učinki nesteroidnih protivnetnih zdravil na ožilje in zgornja prebavila: meta analize podatkov o posameznikih, ki so sodelovali v randomiziranih preskušanjih).
If 1,000 patients at moderate risk took diclofenac for a year, there would be about 3 extra cases of heart attack among them, compared with patients not taking diclofenac. 
Če bi 1.000 bolnikov, pri katerih obstaja zmerno tveganje, eno leto jemalo diklofenak, bi se med njimi pojavili približno 3 primeri srčne kapi več kot med bolniki, ki ne jemljejo diklofenaka.
• Use of diclofenac is contra-indicated in patients with established congestive heart failure (NYHA class II-IV), ischaemic heart disease, peripheral arterial disease or cerebrovascular disease. 
• Uporaba diklofenaka je kontraindicirana pri bolnikih z ugotovljenim kongestivnim srčnim popuščanjem (II.-IV. razred po NYHA), ishemično boleznijo srca, periferno arterijsko boleznijo ali cerebrovaskularnim obolenjem.
• The PRAC has further reviewed available data including several new case-control and cohort studies, a post-hoc analysis of data from the MEDAL (Multinational Etoricoxib and Diclofenac Arthritis Long-term) programme,1 and a meta-analysis2 by the Coxib and traditional NSAID Trialists Collaboration which involved over 600 clinical trials. 
• PRAC je podrobneje pregledal razpoložljive podatke, vključno s podatki iz več novih študij „primerkontrola“ in kohortnih študij, post hoc analizo podatkov iz programa MEDAL (Mednarodni program vrednotenja dolgotrajne uporabe etorikoksiba in diklofenaka pri zdravljenju artritisa)1 in meta analizo2, ki jo je opravila kolaborativna skupina preskuševalcev koksibov in neselektivnih nesteroidnih protivnetnih zdravil (Coxib and Traditional NSAID Trialists Collaboration) in v katero so vključili več kot 600 kliničnih preskušanj.
The PRAC review of diclofenac was started at the request of the UK medicines regulatory agency, the MHRA, in October 2012 in response to findings from the 2012 review of NSAIDs. 
Pregled diklofenaka, ki ga je odbor PRAC opravil na zahtevo regulativne agencije Združenega kraljestva za zdravila (MHRA), se je začel oktobra 2012, po tem, ko so postale znane ugotovitve pregleda nesteroidnih protivnetnih zdravil iz leta 2012.
• Overall, the benefits of this medicine are greater than its risks, but there is a small risk of heart attack or stroke in patients taking systemic diclofenac regularly, especially at high doses (150 mg daily) and for long periods. 
• Na splošno so koristi tega zdravila večje od z njim povezanih tveganj, vendar obstaja majhno tveganje za srčno ali možgansko kap pri bolnikih, ki redno jemljejo sistemski diklofenak, zlasti če ga jemljejo v velikih odmerkih (150 mg na dan) in dlje časa.
However, data from previous reviews carried out in 2005, 2006 and 2012 suggested an increased relative risk of arterial thromboembolic events which was sometimes greater than for other commonly prescribed NSAIDs and in some cases as great or greater than that seen with certain COX-2 inhibitors. 
Vendar pa so podatki iz preteklih pregledov, opravljenih v letih 2005, 2006 in 2012, pokazali povečano relativno tveganje za arterijske trombembolične dogodke, ki je bilo včasih večje kot pri drugih pogosto predpisanih nesteroidnih protivnetnih zdravilih, v nekaterih primerih pa tudi enako veliko ali večje kot pri uporabi nekaterih zaviralcev COX-2.
Most formulations are for systemic use (given as treatment throughout the body, such as oral and injectable medicines), which are covered by the current review. 
Večina farmacevtskih oblik se uporablja za sistemsko zdravljenje (dajejo se kot zdravila, ki delujejo na celotno telo, na primer zdravila za peroralno uporabo ali injiciranje) in so obravnavane v tem pregledu.
• In the light of the above, all patients receiving regular diclofenac therapy should be reviewed at the next scheduled appointment. 
• V skladu z zgoraj navedenim je treba pri vseh bolnikih, ki redno uporabljajo diklofenak, ob naslednjem obisku pri zdravniku ponovno oceniti zdravljenje.
Traditional NSAIDs act by blocking the effects of the two cyclo-oxygenase (COX) enzymes, known as COX-1 and COX-2, resulting in a reduced production of substances called prostaglandins. 
Običajna nesteroidna protivnetna zdravila delujejo tako, da zavirajo učinke obeh encimov ciklooksigenaze (COX), ki ju imenujemo COX-1 in COX-2, zaradi česar se zmanjša nastajanje snovi, imenovanih prostaglandini.
• Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with diclofenac after careful consideration. 
• Bolnike s pomembnimi dejavniki tveganja za srčno-žilne dogodke (npr. hipertenzija, hiperlipidemija, sladkorna bolezen ali kajenje) se lahko zdravi z diklofenakom šele po temeljitem razmisleku.
The CMDh agreed with the PRAC conclusion that although the benefits of systemic diclofenac still outweigh the risks, those risks were similar to the risks with COX-2 inhibitors, and it endorsed the recommendation that similar precautions should be applied. 
Skupina CMDh se je strinjala z ugotovitvijo odbora PRAC, da so kljub dejstvu, da so koristi sistemskega diklofenaka še vedno večje od z njim povezanih tveganj, omenjena tveganja podobna kot pri uporabi zaviralcev COX-2, in podprla priporočilo, da se uvedejo podobni previdnostni ukrepi.