natgillin/translations-raw huggingface dataset:
When reconstituted with 5 ml water for injections the solution contains 400 IU/ml of rVIII-SingleChain.
Po rekonstituciji s 5 ml vode za injekcije raztopina vsebuje 400 i.e./ml enoverižnega rVIII.
AFSTYLA 1500 IU powder and solvent for solution for injection Each vial contains nominally 1500 IU recombinant, single-chain coagulation factor VIII (rVIIISingleChain, INN = lonoctocog alfa).
AFSTYLA 1500 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 1500 i.e. rekombinantnega, enoverižnega koagulacijskega faktorja VIII (enoverižni rVIII, INN = lonoktokog alfa).
AFSTYLA 1500 IU powder and solvent for solution for injection Lonoctocog alfa (recombinant coagulation factor VIII)
AFSTYLA 1500 i.e. prašek in vehikel za raztopino za injiciranje lonoktokog alfa (rekombinantni koagulacijski faktor VIII)
AFSTYLA 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU recombinant, single-chain coagulation factor VIII (rVIIISingleChain, INN = lonoctocog alfa).
AFSTYLA 500 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 500 i.e. rekombinantnega, enoverižnega koagulacijskega faktorja VIII (enoverižni rVIII, INN = lonoktokog alfa).
AFSTYLA 500 IU powder and solvent for solution for injection Lonoctocog alfa (recombinant coagulation factor VIII)
AFSTYLA 500 i.e. prašek in vehikel za raztopino za injiciranje lonoktokog alfa (rekombinantni koagulacijski faktor VIII)
Inhibitors
Zaviralci
AFSTYLA 1000 IU powder for solution for injection Lonoctocog alfa
AFSTYLA 1000 i.e. prašek in vehikel za raztopino za injiciranje lonoktokog alfa za intravensko uporabo
AFSTYLA 500 IU powder for solution for injection Lonoctocog alfa
AFSTYLA 500 i.e. prašek in vehikel za raztopino za injiciranje lonoktokog alfa za intravensko uporabo
Nervous system disorders
Bolezni živčevja omotica pogosti parestezija pogosti
powder and solvent for solution for injection 1 vial with powder: 250 IU lonoctocog alfa (100 IU/ml after reconstitution) 1 vial with 2.5 ml water for injections 1 filter transfer device 20/20
prašek in vehikel za raztopino za injiciranje 1 viala s praškom: 250 i.e. lonoktokoga alfa (100 i.e./ml po rekonstituciji) 1 viala z 2,5 ml vode za injekcije
powder and solvent for solution for injection 1 vial with powder: 500 IU lonoctocog alfa (200 IU/ml after reconstitution) 1 vial with 2.5 ml water for injections 1 filter transfer device 20/20
prašek in vehikel za raztopino za injiciranje 1 viala s praškom: 500 i.e. lonoktokoga alfa (200 i.e./ml po rekonstituciji) 1 viala z 2,5 ml vode za injekcije
The reconstituted solution should be clear to slightly opalescent, yellow to colourless i.e., it might sparkle when held up to the light but must not contain any obvious particles.
Pripravljena raztopina mora biti bistra do rahlo svetlikajoča, rumena do brezbarvna t.j.
Solution For Injection Intramuscular Use | Intravenous Use
Raztopina za injiciranje Intramuskularna uporaba | intravenska uporaba
Metylprednizolón Hikma Methylprednisolone 53mg Vial
Metylprednizolón Hikma Metilprednizolon 53 mg viala
Powder And Solvent For Solution For Injection/Infusion
Prašek in vehikel za raztopino za injiciranje/infundiranje
Lyophilisate And Solvent For Solution For Injection
Liofilizat in vehikel za raztopino za injiciranje
Methylprednisolone Hemisuccinate 50.7mg Vial
Metilprednizolon hemisukcinat 50,7 mg viala
Methylprednisolone Hemisuccinate 50.68mg Bottle
Metilprednizolon hemisukcinat 50,68 mg steklenička
Methylprednisolone Hemisuccinate 25.35mg Vial
Metilprednizolon hemisukcinat 25,35 mg viala
Metilprednizolon Teva Methylprednisolone Sodium Succinate 40mg Vial
Metilprednizolon Teva Metilprednizolon natrijev sukcinat 40 mg viala
Methylprednisolone Hemisuccinate 25.34mg Bottle
Metilprednizolon hemisukcinat 25,34 mg steklenička
Methylprednisolone 40mg Tablet
Metilprednizolon 40 mg tableta
Metilprednisolon Teva Methylprednisolone Sodium Succinate 53mg Vial
Metilprednisolon Teva Metilprednizolon natrijev sukcinat 53 mg viala
Methylprednisolone 120mg Bottle
Metilprednizolon 120 mg steklenička
The patient's blood should be monitored regularly to see how the medicine is working.
Redno je treba spremljati bolnikovo kri, da se preveri delovanje zdravila.
The recommended dose is one capsule a day taken during the evening meal.
Priporočeni odmerek je ena kapsula na dan, ki se zaužije med večernim obrokom.
It must not be given to women who are pregnant or breastfeeding.
Ne smejo ga uporabljati ženske, ki so noseče ali dojijo.
Pravafenix pravastatin/fenofibrate
Pravafenix pravastatin/fenofibrat
The medicine should always be taken with food as it is less well absorbed from an empty stomach.
Zdravilo je vedno treba jemati skupaj s hrano, saj se iz praznega želodca slabše absorbira.
Fenofibrate is a ‘PPAR agonist'.
Fenofibrat je „agonist PPAR“.
It is available as green and olive capsules containing 40 mg pravastatin and 160 mg fenofibrate.
Na voljo je v obliki zelenih in olivno zelenih kapsul, ki vsebujejo 40 mg pravastatina in 160 mg fenofibrata.
The European Commission granted a marketing authorisation valid throughout the European Union for Pravafenix to Laboratoires SMB s.a. on 14 April 2011.
Evropska komisija je dovoljenje za promet z zdravilom Pravafenix, veljavno po vsej Evropski uniji, odobrila družbi Laboratoires SMB s.a. dne 14. aprila 2011.
Pravastatin belongs to the group called ‘statins'.
Pravastatin spada v skupino, imenovano „statini“.
Because pravastatin and fenofibrate have been used in medicines for a number of years, the company presented information from the scientific literature in addition to results from its own studies.
Ker se pravastatin in fenofibrat v zdravilih uporabljata že vrsto leto, je družba poleg rezultatov lastnih študij predstavila tudi informacije iz znanstvene literature.
The full EPAR for Pravafenix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Pravafenix je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
This is a summary of the European public assessment report (EPAR) for Pravafenix.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pravafenix.
The main measure of effectiveness was the reduction in the level of cholesterol after 12 weeks (excluding HDL or ‘good' cholesterol).
Glavno merilo učinkovitosti je bilo znižanje ravni holesterola po 12 tednih (brez holesterola HDL ali „dobrega“ holesterola).
The doctor should stop treatment if an adequate response is not seen within three months.
Če zadosten odziv ni dosežen v treh mesecih, mora zdravnik zdravljenje prekiniti.
For more information about treatment with Pravafenix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Pravafenix preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The Committee therefore decided that Pravafenix's benefits are greater than its risks in this group of patients and recommended that it be given marketing authorisation.
Zato je zaključil, da so koristi zdravila Pravafenix večje od z njim povezanih tveganj pri tej skupini bolnikov, in priporočil, da se zanj odobri dovoljenje za promet.
The CHMP looked at newly published data on the benefits of the combination of statins and fenofibrate.
Odbor za zdravila za uporabo v humani medicini (CHMP) je pregledal novo objavljene podatke o koristih kombinacije statinov in fenofibrata.
It activates a type of receptor called the ‘peroxisome proliferator-activated receptor alpha', which is involved in breaking down fat from the diet, especially triglycerides.
Aktivira vrsto receptorjev, imenovanih „peroksisomski proliferator aktiviranega receptorja alfa“, ki vpliva na razgradnjo maščob iz prehrane, zlasti trigliceridov.
Before starting treatment with Pravafenix, the doctor should first investigate all possible causes of the patient's abnormal cholesterol and triglycerides levels and place the patient on a suitable diet.
Pred začetkom zdravljenja z zdravilom Pravafenix mora zdravnik najprej proučiti vse možne vzroke za bolnikove nenormalne ravni holesterola in trigliceridov ter bolniku predpisati ustrezno dieto.
Pravafenix is a medicine that contains the active substances pravastatin and fenofibrate.
Pravafenix je zdravilo, ki vsebuje zdravilni učinkovini pravastatin in fenofibrat.
The cholesterol drawn out of the blood in this way is the LDL, or ‘bad' cholesterol.
Holesterol, ki se iz krvi odstrani na tak način, je holesterol LDL ali „slabi“ holesterol.
The active substances in Pravafenix, pravastatin and fenofibrate, work in different ways and their actions have a complementary effect.
Zdravilni učinkovini v zdravilu Pravafenix, pravastatin in fenofibrat, delujeta različno, njuni učinki pa se med seboj dopolnjujejo.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Pravafenix.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Pravafenix, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
As the liver needs cholesterol to produce bile, the reduced blood cholesterol level causes the liver cells to produce receptors that draw cholesterol from the blood, reducing its level even further.
Ker jetra holesterol potrebujejo za proizvajanje žolča, znižana raven holesterola v krvi povzroča, da celice jeter proizvajajo receptorje, ki črpajo holesterol iz krvi in tako njegovo raven še bolj znižujejo.
Pravafenix should not be used in people who may be hypersensitive (allergic) to the active substances or any of the other ingredients.
Zdravila Pravafenix ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) zdravilni učinkovini ali katero koli drugo sestavino zdravila.
The most common side effects with Pravafenix (seen in between 1 and 10 patients in 100) are abdominal distension (bloating), abdominal pain (stomach ache), constipation, diarrhoea, dry mouth, dyspepsia (heartburn), eructation (belching), flatulence (gas), nausea (feeling sick), abdominal discomfort, vomiting and raised blood levels of liver enzymes.
Najpogostejši neželeni učinki zdravila Pravafenix (opaženi pri 1 do 10 bolnikih izmed 100) so napihnjenost trebuha, bolečina v trebuhu, zaprtost, driska, suha usta, dispepsija (zgaga), kolcanje (spahovanje), napenjanje (plini), navzeja (slabost), neugodje v trebuhu, bruhanje in povečana koncentracija jetrnih encimov v krvi.
The company carried out one main study, in which Pravafenix was compared with pravastatin alone in 248 patients at high risk of heart disease who had abnormal levels of cholesterol and triglyceride fats.
Družba je izvedla eno glavno študijo, v kateri so zdravilo Pravafenix primerjali z monoterapijo s pravastatinom pri 248 bolnikih z visokim tveganjem za bolezen srca, ki so imeli nenormalno raven holesterola in trigliceridnih maščob.
What benefit has Pravafenix shown during the studies?
Kakšne koristi je zdravilo Pravafenix izkazalo med študijami?
Non-HDL-cholesterol levels were reduced on average by around 14% in patients taking Pravafenix compared with 6% in patients taking pravastatin alone.
Raven holesterola zaradi lipoproteinov nevisoke gostote se je v povprečju znižala za okoli 14 % pri bolnikih, ki so jemali zdravilo Pravafenix, v primerjavi s 6 % pri bolnikih, ki so jemali samo pravastatin.
Pravafenix is used in adults at high risk of heart disease whose ‘low-density-lipoprotein' (LDL or ‘bad') cholesterol is already being controlled with pravastatin alone but who still need to improve their cholesterol levels and to reduce their levels of triglycerides (a type of fat).
Zdravilo Pravafenix se uporablja za zdravljenje odraslih bolnikov z visokim tveganjem za bolezen srca, pri katerih so vrednosti holesterola zaradi „lipoproteinov nizke gostote“ (holesterol LDL ali slabi holesterol) že nadzirane z monoterapijo s pravastatinom, vendar morajo kljub temu še izboljšati raven holesterola in zmanjšati raven trigliceridov (vrsta maščob).
For the full list of all side effects reported with Pravafenix, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Pravafenix, glejte navodilo za uporabo.
Pravafenix must not be used in patients aged below 18 years or in patients with severe liver problems, moderate to severe kidney problems, photo allergy or phototoxic reactions (allergic reaction or skin damage due to light exposure) during treatment with fibrates or ketoprofen.
Ne smejo ga uporabljati bolniki, mlajši od 18 let, ali bolniki s hudimi težavami z jetri, zmernimi do hudimi težavami z ledvicami, s fotoalergijo ali fototoksičnimi reakcijami (alergijskimi reakcijami ali poškodbami kože zaradi izpostavljenosti svetlobi) pri zdravljenju s fibrati ali ketoprofenom.
It must also not be used in patients with gall bladder disease, chronic or acute pancreatitis (inflammation of the pancreas) or a history of myopathy (muscle disorders) or rhabdomyolysis (breakdown of muscle fibres) following treatment with a statin or a fibrate.
Prav tako ga ne smejo uporabljati bolniki z boleznijo žolčnika, s kroničnim ali akutnim pankreatitisom (vnetjem trebušne slinavke) ali bolniki z anamnezo miopatije (mišične motnje) ali rabdomiolize (razpadanjem mišičnih vlaken) po zdravljenju s statinom ali fibratom.
What is the risk associated with Pravafenix?
Kakšna tveganja so povezana z zdravilom Pravafenix?
Other information about Pravafenix
Druge informacije o zdravilu Pravafenix:
When the receptors are activated, the breakdown of fats is accelerated, and this helps clear the blood of cholesterol and triglycerides.
Aktiviranje receptorjev pospeši razgradnjo maščob, kar pomaga pri odstranjevanju holesterola in trigliceridov iz krvi.
It reduces total blood cholesterol by blocking the action of HMG-CoA reductase, an enzyme in the liver involved in the production of cholesterol.
Zmanjšuje raven skupnega holesterola z zaviranjem delovanja reduktaze HMG-CoA, encima v jetrih, ki sodeluje pri proizvajanju holesterola.
In the main study Pravafenix was shown to be more effective than pravastatin alone in reducing nonHDL-cholesterol levels.
V glavni študiji se je zdravilo Pravafenix izkazalo kot učinkovitejšega od samega pravastatina pri zniževanju ravni holesterola zaradi lipoproteinov nevisoke gostote.
The Committee also noted that the benefits of Pravafenix were mainly in patients who had high levels of triglyceride fats and low levels of HDL cholesterol.
Menil je, da se koristi zdravila Pravafenix kažejo predvsem pri bolnikih z visoko ravnjo trigliceridnih maščob in nizko ravnjo holesterola HDL.
Why has Pravafenix been approved?
Zakaj je bilo zdravilo Pravafenix odobreno?
How has Pravafenix been studied?
Kako je bilo zdravilo Pravafenix raziskano?
What is Pravafenix used for?
Za kaj se zdravilo Pravafenix uporablja?
What is Pravafenix?
Kaj je zdravilo Pravafenix?
How does Pravafenix work?
Kako zdravilo Pravafenix deluje?
How is Pravafenix used?
Kako se zdravilo Pravafenix uporablja?
Ref. EMEA/263700/2008
: EMEA/263700/2008
1 Procedure under Article 107 of Directive 2001/83/EC, as amended.
1 Postopek v skladu s členom 107 Direktive 2001/83/ES, kakor je bila spremenjena.
Nimesulide is available as branded and generic medicines in the following Member States: Austria, Bulgaria, the Czech Republic, Cyprus, France, Greece, Hungary, Italy, Latvia, Lithuania, Malta, Poland, Portugal, Romania, Slovakia and Slovenia.
Nimesulid je sestavina originatorskih in generičnih zdravil v naslednjih državah članicah: Avstrija, Bolgarija, Češka, Ciper, Francija, Grčija, Madžarska, Italija, Latvija, Litva, Malta, Poljska, Portugalska, Romunija, Slovaška in Slovenija.
Until December 2007, it was also available in Belgium.
Do decembra 2007 je bil odobren tudi v Belgiji.
The European Commission issued a decision on 16 October 2009.
Evropska komisija je sklep izdala dne 16. oktobra 2009.
London, 16 October 2009 Doc.
London, 16. oktobra 2009 Sklic dok.
What are the conclusions of the review?
Kakšni so zaključki pregleda?
This should be carried out in a separate ‘Article 31' referral procedure.
To je treba izvesti v ločenem napotitvenem postopku v skladu s členom 31.
The CHMP opinion adopted in September 2007 was transmitted to the European Commission so that it could issue a final decision.
Mnenje CHMP iz septembra 2007 je bilo predloženo Evropski komisiji, da bi ta lahko izdala končni sklep.
Questions and answers on the outcome of the review of nimesulide-containing medicines1
Vprašanja in odgovori v zvezi z izidom pregleda zdravil, ki vsebujejo nimesulid1
The Committee has also reviewed the results of an Italian ‘simulation study', carried out by the Italian medicines regulatory authority.
Odbor je pregledal tudi rezultate italijanske „simulacijske študije,“ ki jo je izvedel italijanski regulativni organ za zdravila.
Products containing nimesulide have been available since 1985 and are authorised in a number of Member States2.
Zdravila, ki vsebujejo nimesulid, se uporabljajo od leta 1985 in so odobrena v številnih državah članicah2.
3 The details on the actions taken by the EMEA and of their outcome can be found in the question-and-answer document published in September 2007.
3 Podrobnosti o ukrepih agencije EMEA in njihovih izidih lahko najdete v dokumentu z vprašanji in odgovori, ki je bil objavljen septembra 2007.
This process involves a consultation step with the Standing Committee for Medicinal Products for Human Use, a body of representatives from Member States.
Ta postopek vključuje posvetovanje s Stalnim odborom za zdravila za uporabo v humani medicini, ki je organ predstavnikov držav članic.
However, the CHMP further concluded that the benefits and risks of nimesulide should be assessed in a wider context.
Vendar pa je CHMP nadalje zaključil, da je treba koristi in tveganja nimesulida proučiti v širšem kontekstu.
‘Systemic formulations' are medicines that are given as a treatment throughout the body, such as tablets, solutions and suppositories.
„Sistemske formulacije“ so zdravila, ki se uporabljajo na celem telesu, npr. tablete, raztopine in svečke.
It is used to treat acute (short-term) pain, and the symptoms of painful osteoarthritis (swelling in the joints) and primary dysmenorrhoea (period pains).
Uporablja se za zdravljenje akutnih (kratkotrajnih) bolečin ter simptomov bolečega osteoartritisa (otekanja sklepov) in primarne dismenoreje (boleče menstruacije).
The European Commission asked the Committee to prepare an opinion on whether the marketing authorisations for products containing nimesulide should be maintained, changed, suspended or withdrawn across the EU.
Evropska komisija je pozvala Odbor, da oblikuje mnenje, ali naj se dovoljenja za promet z zdravili, ki vsebujejo nimesulid, v EU ohranijo, spremenijo, začasno prekličejo ali umaknejo.
At the end of the review in September 2007, the CHMP concluded that the available data did not support a suspension of all marketing authorisations in Europe.
Ob zaključku pregleda septembra 2007 je CHMP zaključil, da razpoložljivi podatki niso potrdili začasnega preklica vseh dovoljenj za promet v Evropi.
The Commission also made it clear that the companies that market nimesulide-containing medicines should inform doctors about the medicines' risks.
Komisija je tudi jasno navedla, da morajo družbe, ki tržijo zdravila, ki vsebujejo nimesulid, zdravnike obvestiti o tveganjih, povezanih z njim.
Because of the severity of the side effects, the European Commission recommended that further measures be taken to ensure that the risk of these side effects is lowered.
Zaradi resnosti neželenih učinkov je Evropska komisija priporočila sprejetje nadaljnjih ukrepov, da se zagotovi zmanjšanje tveganja teh neželenih učinkov.
However, it recommended that some restrictions should be placed on the way these medicines are prescribed, including limiting the pack size to 30 doses, and that the information provided to doctors and patients be amended to limit the risk of liver injury
Vendar pa je priporočil uvedbo nekaterih omejitev v zvezi z načinom predpisovanja teh zdravil, vključno z omejitvijo velikosti pakiranja na 30 odmerkov, ter dopolnitev informacij za zdravnike in bolnike, tako da se omeji tveganje za okvaro jeter3.
The Standing Committee could not reached an agreement, and, on 8 February 2008, the European Commission therefore asked the CHMP to further consider its opinion, taking new data on the risk of liver problems into account, in particularly new data supplied by Ireland, and looking at ways of minimising the risk associated with nimesulide.
Stalni odbor ni uspel doseči sporazuma, zato je 8. februarja 2008 Evropska komisija odbor CHMP pozvala, naj nadaljuje s presojo, pri čemer naj upošteva nove podatke o tveganju težav z jetri, zlasti nove podatke, ki jih je predložila Irska, in obravnava načine zmanjšanja tveganj v zvezi z nimesulidom.
The simulation took the impact of patients switching to alternative painkiller medicines into account.
Simulacija je upoštevala vpliv na bolnike, ki so prešli na drugo zdravilo proti bolečinam.
This review should look at all of the potential risks of the medicine, especially the risk of side effects affecting the stomach and the gut, which were outside the scope of the original Article 107 procedure.
Ta pregled mora upoštevati vsa morebitna tveganja zdravila, zlasti tveganja neželenih učinkov na želodec in črevesje, ki jih izvirni postopek v skladu s členom 107 ni urejal.
The European Commission endorsed the CHMP opinion with a further restriction to limit the use of these medicines to ‘second-line' (used when at least one other medicine has failed).
Evropska komisija je potrdila mnenje CHMP z nadaljnjo omejitvijo, da se ta zdravila uporabljajo šele kot zdravilo druge izbire (tj. če je bilo vsaj eno drugo zdravilo neuspešno).
The CHMP noted that the only additional measures taken by Member States were changes to the prescription status or reimbursement levels for nimesulide-containing medicines.
CHMP je ugotovil, da so edini dodatni ukrepi držav članic spremembe načina predpisovanja ali ravni povračil za zdravila, ki vsebujejo nimesulid.
This type of referral is used when it is of ‘Community interest' (for the benefit of all Member States) to have a common view on the benefit-risk balance of a medicine.
Ta vrsta napotitvenega postopka se uporablja, kadar je skupno mnenje o razmerju med koristmi in tveganji za zdravilo „pomembno za Skupnost“ (v korist vseh držav članic).
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of these medicines still outweigh their risks, and that there is a need to restrict their use to ensure that the risk of patients developing liver problems is kept to a minimum.
Odbor za zdravila za uporabo v humani medicini (CHMP) Evropske agencije za zdravila je zaključil, da koristi teh zdravil še vedno odtehtajo z njimi povezana tveganja ter da je treba na najmanjšo možno mero omejiti njihovo uporabo, da se zagotovi zmanjšanje tveganja za bolnike, pri katerih se pojavijo težave z jetri.
The review of the liver-related safety of ‘systemic formulations' of medicines containing nimesulide has been completed.
Pregled „sistemskih formulacij“ zdravil, ki vsebujejo nimesulid, glede varnosti za jetra je zaključen.
The review was an article 107 procedure triggered by the decision of Ireland's medicines regulatory authority in May 2007 to suspend the marketing authorisation for systemic nimesulide-containing medicines, mainly because of liver problems.
Pregled je bil izveden po postopku v skladu s členom 107, sprožil pa ga je sklep irskega regulativnega organa za zdravila maja 2007, da se začasno prekliče dovoljenje za promet s sistemskimi zdravili, ki vsebujejo nimesulid, predvsem zaradi težav z jetri.