FrancophonIA/ELRC3.0 huggingface dataset:
English: D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Slovenian: DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Store and transport refrigerated.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte in prevažajte v hladilniku.
English: Adjuvants:
Slovenian: Dodatki:
English: Specific pharmacovigilance requirements:
Slovenian: D. DRUGI POGOJI IN ZAHTEVEDOVOLJENJA ZA PROMET Z ZDRAVILOM Posebne farmakovigilančne zahteve:
English: Major incompatibilities: Do not mix with any other veterinary medicinal product.
Slovenian: InkompatibilnostiNe mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini.
English: Suvaxyn PCV suspension for injection for pigs
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Suvaxyn PCV suspenzija za injiciranje za prašiče
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste material derived from the use of such products, if appropriate
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi, ki nastanejo pri uporabi teh zdravil
English: MARKETING AUTHORISATION NUMBERS
Slovenian: ŠTEVILKA() DOVOLJENJA ZA PROMET
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Boxes of 10 bottles of 10, 50 or 125 doses Boxes of 1 bottle of 10, 50 or 125 doses
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla z 10 plastenkami z 10, 50 ali 125 odmerki Škatla z 1 plastenko z 10, 50 ali 125 odmerki
English: Minimum Essential Medium without phenol red Sodium bicarbonate
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi tiomersal minimalni esencialni medij brez fenolnega rdečega natrijev bikarbonat hepes kislina voda za injekcije
English: Inactivated recombinant Porcine Circovirus type 1 expressing the Porcine Circovirus type 2 ORF2 protein 1.6 ≤ RP ≤ 5.3
Slovenian: KOLIČINA) UČINKOVIN(E) Inaktiviran rekombinanten prašičji cirkovirus tipa 1 z izraženim proteinom ORF2 prašičjega cirkovirusa tipa 2 1.6 ≤ RP ≤ 5.3
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo.
English: The vaccine strain is an inactivated recombinant Porcine Circovirus type 1 expressing the Porcine Circovirus type 2 ORF2 protein.
Slovenian: Sev v cepivu je inaktiviran rekombinanten prašičji cirkovirus tipa 1 z izraženim proteinom ORF2 prašičjega cirkovirusa tipa 2.
English: MARKETING AUTHORISATION NUMBER(S)
Slovenian: ŠTEVILKA(E) DOVOLJENJA ZA PROMET
English: Read the package leaflet before use.
Slovenian: NAČIN IN POT(I) UPORABE Pred uporabo preberite navodilo za uporabo.
English: Inactivated recombinant Porcine Circovirus type 1 expressing the Porcine Circovirus type 2 ORF2 protein
Slovenian: Inaktiviran recombinanten prašičji cirkovirus tip 1 z izraženim proteinom ORF2 prašičjega cirkovirusa tipa 2
English: Pigs (piglets)
Slovenian: CILJNE ŽIVALSKE VRSTE Prašiči (pujski).
English: Box of 1 bottle of 10 doses Box of 1 bottle of 50 doses Box of 1 bottle of 125 doses
Slovenian: Škatla z 1 plastenko z 10 odmerki Škatla z 1 plastenko s 50 odmerki Škatla z 1 plastenko s 125 odmerki
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov proizvajalca (proizvajalcev) zdravila, odgovornega (odgovornih) za sproščanje serij
English: Cardboard box of 1 bottle of 10 doses (20 ml), 50 doses (100 ml) or 125 doses (250 ml).
Slovenian: Kartonska škatla z 1 plastenko z 10 odmerki (20 ml), 50 odmerki (100 ml) ali 125 odmerki (250 ml).
English: No adverse reactions except those mentioned in section 6 were observed after the administration of a double dose of vaccine.
Slovenian: Po dajanju dvojnega odmerka cepiva ni bilo opaziti nobenih drugih neželenih učinkov kot tistih, opisanih v poglavju 6.
English: Box of 10 bottles of 10 doses Box of 10 bottles of 50 doses Box of 10 bottles of 125 doses
Slovenian: Škatla z 10 plastenkami z 10 odmerki Škatla z 10 plastenkami s 50 odmerki Škatla z 10 plastenkami s 125 odmerki
English: Excipients:
Slovenian: Učinkovina:
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Po dajanju dvojnega odmerka cepiva ni bilo opaziti nobenih drugih neželenih učinkov kot tistih, opisanih v poglavju 4.6.
English: EXPIRY DATE
Slovenian: EXP {mesec/leto}
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Zoetis Belgium SA
English: Pregnancy and lactation: Do not use during pregnancy and lactation.
Slovenian: Ne uporabite v obdobju brejosti in laktacije.
English: EXP {month/year} Once broached use immediately.
Slovenian: Načeto zdravilo uporabite takoj
English: Cardboard box of 10 bottles of 10 doses (20 ml), 50 doses (100 ml) or 125 doses (250 ml).
Slovenian: Kartonska škatla z 10 plastenkami z 10 odmerki (20 ml), 50 odmerki (100 ml) ali 125 odmerki
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle label 50 and 125 doses
Slovenian: PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI Plastenka s 50 in 125 odmerki
English: QUANTITY OF THE ACTIVE SUBSTANCES
Slovenian: NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Slovenian: - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali).
English: Marketing authorisation holder: Zoetis Belgium SA Rue Laid Burniat 1
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Zoetis Belgium SA
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle label 10 doses
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Slovenian: NAVEDBA UČINKOVIN(E)
English: Outcome of a procedure under Article 13 of Regulation (EC) No 1234/2008
Slovenian: Izid postopka v skladu s členom 13 Uredbe (ES) št. 1234/2008
English: 1 A procedure through which an authorisation of a medicine in one European Union Member State is recognised by another Member State.
Slovenian: Postopek, po katerem odobritev zdravila v eni državi članici Evropske unije prizna druga država članica.
English: Why was Cardioxane reviewed?
Slovenian: Zakaj je bilo zdravilo Cardioxane pregledano?
English: ANSM did not agree to the changes as requested by the company.
Slovenian: Agencija ANSM se ni strinjala s spremembami, ki jih je vložila družba.
English: Its Committee for Medicinal Products for Human Use (CHMP) concluded that such a removal is acceptable.
Slovenian: Njen Odbor za zdravila za uporabo v humani medicini (CHMP) je razsodil, da je odprava sprejemljiva.
English: Cardioxane is authorised under a ‘mutual recognition' procedure1 based on an initial authorisation granted by France.
Slovenian: Zdravilo Cardioxane je bilo odobreno za promet po postopku medsebojnega priznavanja1 na podlagi prvotnega dovoljenja, ki ga je izdala Francija.
English: Cardioxane is authorised in the Czech Republic, Germany, France, Italy, the Netherlands, Poland, Spain and the United Kingdom.
Slovenian: Zdravilo Cardioxane ima dovoljenje za promet na Češkem, v Nemčiji, Franciji, Italiji, na Nizozemskem, Poljskem, v Španiji in Združenem kraljestvu.
English: The company wanted the changes to be recognised in Czech Republic, Germany, France, Italy, the Netherlands, Poland, Spain and the United Kingdom (the ‘concerned Member States').
Slovenian: Družba je želela, da se spremembe dovoljenja za promet z zdravilom, priznajo na Češkem, v Nemčiji, Franciji, Italiji, na Nizozemskem, Poljskem in v Združenem kraljestvu („zadevne države članice“).
English: On 18 May 2017, the European Medicines Agency completed an arbitration procedure for Cardioxane (dexrazoxane powder for solution for injection).
Slovenian: 18. maja 2017 je Evropska agencija za zdravila končala postopek arbitraže za zdravilo Cardioxane (deksrazoksan prašek za raztopino za injiciranje).
English: What is Cardioxane?
Slovenian: Kaj je zdravilo Cardioxane?
English: However, as there are a small number of patients under 18 years who require high doses of anthracyclines and who are therefore at greater risk of harmful effects on the heart, the Committee agreed that the contraindication should be lifted for this group.
Slovenian: Ker pa obstaja majhno število bolnikov, mlajših od 18 let, ki potrebujejo velike odmerke antraciklinov, zaradi česar je tveganje za škodljive učinke na srce pri njih večje, se je odbor strinjal, da se kontraindikacija za to skupino odpravi.
English: Cardioxane is a medicine used in adults with breast cancer to prevent long-term harmful effects on the heart caused by treatment with the anthracycline cancer medicines doxorubicin and epirubicin.
Slovenian: Cardioxane je zdravilo, ki se uporablja za zdravljenje raka dojk pri odraslih za preprečevanje dolgoročnih škodljivih učinkov na srce, ki jih povzroča zdravljenje z antraciklinskima zdraviloma proti raku doksorubicinom in epirubicinom.
English: The company that markets the medicine is Clinigen Healthcare Limited.
Slovenian: To zdravilo trži družba Clinigen Healthcare Limited.
English: Because of concerns that it might increase the risk of second cancers developing long after treatment, the CHMP reviewed the medicine2 in September 2011 and recommended on the basis of the evidence at that time that use of medicines containing dexrazoxane to protect the heart should be explicitly contraindicated in children and adolescents.
Slovenian: Zaradi pomislekov, da bi lahko povečalo tveganje za sekundarne rake, ki se razvijejo dolgo po zdravljenju, je odbor CHMP septembra 2011 zdravilo pregledal2 in na podlagi tedanjih dokazov priporočil, da je treba uporabo zdravil, ki vsebujejo deksrazoksan, za zaščito srca izrecno kontraindicirati pri otrocih in mladostnikih.
English: Based on evaluation of the currently available data, and the scientific discussion within the Committee, the CHMP concluded that the benefits and risks of Cardioxane have not been established in children under the age of 18 years, in whom it is not licensed, particularly given that most young patients do not receive the high total doses of anthracyclines that can cause damage to the heart.
Slovenian: Na osnovi vrednotenja trenutno razpoložljivih podatkov in znanstvene razprave znotraj odbora je odbor CHMP zaključil, da koristi in tveganja zdravila Cardioxane pri otrocih, mlajših od 18 let, za katere zdravilo ni odobreno, niso bili ugotovljeni, zlasti glede na to, da večina mladih bolnikov ne prejema velikih skupnih odmerkov antraciklinov, ki bi lahko škodovali srcu.
English: In 2015, Clinigen submitted an application to the French medicines regulator ANSM for changes to the terms of the marketing authorisation, including removal of the contraindication in children and adolescents.
Slovenian: Družba Clinigen je leta 2015 francoski regulativni agenciji za zdravila ANSM predložila vlogo za spremembo pogojev dovoljenja za promet z zdravilom, vključno z odpravo kontraindikacije za otroke in mladostnike.
English: The way in which dexrazoxane protects the heart is not entirely clear, but may be linked to the way the medicine attaches to charged iron particles that are involved in the processes that make anthracyclines harmful to the heart muscle.
Slovenian: Način zaščitnega delovanja deksrazoksana na srce še ni povsem jasen, vendar je morda povezan s tem, kako se zdravilo veže na nabite železove delce, vključene v procese, zaradi katerih so antraciklini škodljivi za srčno mišico.
English: However ANSM and the concerned Member States were unable to reach agreement on whether the contraindication could be removed just for children and adolescents treated with high cumulative doses of anthracyclines, and, on 31 January 2017, France referred the matter to the CHMP for arbitration.
Slovenian: Agencija ANSM in zadevne države članice niso dosegle soglasja o odpravi kontraindikacije samo za otroke in mladostnike, ki se zdravijo z velikimi kumulativnimi odmerki antraciklinov, zato je Francija 31. januarja 2017 zadevo napotila na odbor CHMP v arbitražo.
English: The European Commission issued an EU-wide legally binding decision to implement the CHMP recommendations on Cardioxane on 19/07/2017.
Slovenian: Evropska komisija je dne 19/07/2017 izdala končno pravno zavezujočo odločbo za vse države članice EU, da uvedejo priporočila odbora CHMP o zdravilu Cardioxane.
English: CHMP therefore concluded that the product information should state that the medicine is contraindicated in patients under 18 years old who are intended to receive a total cumulative dose of less than 300 mg of doxorubicin per m2 body surface or an equivalent dose of another anthracycline medicine.
Slovenian: Odbor CHMP je torej zaključil, da morajo informacije o zdravilu navajati, da je zdravilo kontraindicirano pri bolnikih, mlajših od 18 let, pri katerih je načrtovan kumulativni odmerek manj kot 300 mg doksorubicina na m2 telesne površine oziroma ustrezen odmerek drugega antraciklinskega zdravila.
English: The grounds for the referral were the concerns of the UK that removing the contraindication in patients less than 18 years old receiving a high cumulative dose of anthracyclines was not justified given the remaining uncertainties regarding the safety and effectiveness of Cardioxane in this population, particularly given the previous decision of the CHMP regarding dexrazoxane medicines.
Slovenian: Razlog za napotitev so bili pomisleki Združenega kraljestva, da odprava kontraindikacije pri bolnikih, mlajših od 18 let, ki prejemajo velike kumulativne odmerke antraciklinov, ni utemeljena, saj obstajajo nejasnosti o varnosti in učinkovitosti zdravila Cardioxane pri tej populaciji, zlasti glede na predhodno odločitev odbora CHMP v zvezi z zdravili, ki vsebujejo deksrazoksan.
English: The Agency had been asked to arbitrate on the removal of the contraindication for children and adolescents treated with high cumulative doses of cancer medicines called anthracyclines.
Slovenian: Agencija je bila zaprošena, naj razsodi glede odprave kontraindikacije za otroke in mladostnike, ki se zdravijo z velikimi kumulativnimi odmerki zdravil proti raku, imenovanimi antraciklini.
English: The contraindication should however remain in children and adolescents who are given lower cumulative doses of anthracyclines.
Slovenian: Kontraindikacija pa mora ostati pri otrocih in mladostnikih, ki prejemajo majhne kumulativne odmerke antraciklinov.
English: It contains the active substance dexrazoxane.
Slovenian: Vsebuje zdravilno učinkovino deksrazoksan.
English: 20 January 2012
Slovenian: 20. januar 2012
English: The European Commission issued a decision on 20 January 2012.
Slovenian: Evropska komisija je odločbo izdala dne 20. januarja 2012.
English: It has been used to treat:
Slovenian: Uporablja se za zdravljenje:
English: Systemic nimesulide medicines are available in the following Member States: Bulgaria, Czech Republic, Cyprus, France, Greece, Hungary, Italy, Latvia, Lithuania, Malta, Poland, Portugal, Romania, Slovakia and Slovenia.
Slovenian: Sistemska zdravila, ki vsebujejo nimesulid, so na voljo v naslednjih državah članicah: Bolgarija, Češka republika, Ciper, Francija, Grčija, Madžarska, Italija, Latvija, Litva, Malta, Poljska, Portugalska, Romunija, Slovaška in Slovenija.
English: 1 Article 107 of Directive 2001/83/EC as amended.
Slovenian: 1 Člen 107 Direktive 2001/83/ES, kakor je bila spremenjena.
English: What is nimesulide?
Slovenian: Kaj je nimesulid?
English: • acute (short-term) pain,
Slovenian: • akutnih (kratkotrajnih) bolečin,
English: • Patients who have any questions should speak to their doctor or pharmacist.
Slovenian: • Bolniki, ki imajo kakršna koli vprašanja, naj se pogovorijo z zdravnikom ali farmacevtom.
English: Medicines containing nimesulide have been available since 1985 and are authorised in a number of Member States.
Slovenian: Zdravila, ki vsebujejo nimesulid, se uporabljajo od leta 1985 in so odobrena v številnih državah članicah.
English: They are only available with a prescription.
Slovenian: Dobijo se samo na recept.
English: Which data has the CHMP reviewed?
Slovenian: Katere podatke je CHMP pregledal?
English: Nimesulide-containing medicines are authorised but not marketed in Austria and in Ireland.
Slovenian: Zdravila, ki vsebujejo nimesulid, so odobrena, vendar se ne tržijo, v Avstriji in na Irskem.
English: Why was nimesulide reviewed?
Slovenian: Zakaj je bil nimesulid pregledan?
English: All information can be found on the Agency website under Regulatory > Human medicines > Referral procedures> Final decisions
Slovenian: Za več informacij glejte spletno stran Evropske agencije za zdravila Regulatory > Human medicines > Referral procedures > Final decisions.
English: It also reviewed data from the published literature, including published clinical studies, reviews and overviews and combined analyses of results from various studies (pooled analyses and meta-analyses).
Slovenian: Pregledal je tudi podatke iz objavljene literature, vključno z objavljenimi kliničnimi študijami, ocenami, pregledi in kombiniranimi analizami rezultatov iz več študij (združene analize in metaanalize).
English: Nimesulide was reviewed in 2007 because of concerns with liver injury.
Slovenian: Nimesulid je bil pregledan leta 2007 zaradi zadržkov glede okvare jeter.
English: The European Medicines Agency has completed a review of the safety and effectiveness of systemic medicines containing nimesulide (capsules, tablets, suppositories and powder or granules for oral suspension).
Slovenian: Evropska agencija za zdravila je opravila pregled varnosti in učinkovitosti sistemskih zdravil, ki vsebujejo nimesulid (kapsule, tablete, svečke in prašek ali zrnca za peroralno suspenzijo).
English: Nimesulide is a non-selective non-steroidal anti-inflammatory drug (NSAID).
Slovenian: Nimesulid je neselektivno nesteroidno protivnetno zdravilo (NSAID).
English: • Nimesulide should only be used as a second choice, and only in the treatment of acute pain or dysmenorrhoea.
Slovenian: • Nimesulid naj se uporablja le kot zdravilo druge izbire in le za zdravljenje akutne bolečine ali dismenoreje.
English: Consequently, on 19 January 2010, the European Commission asked the CHMP to carry out a full assessment of the benefit-risk balance of nimesulide and to issue an opinion on whether the marketing authorisations for systemic medicine containing nimesulide should be maintained, varied, suspended or withdrawn across the European Union.
Slovenian: Posledično je Evropska komisija 19. januarja 2010 prosila CHMP za izvedbo polne ocene razmerja med tveganji in koristmi za nimesulid ter za izdajo mnenja o tem, ali naj se dovoljenja za promet s sistemskimi zdravili, ki vsebujejo nimesulid, v EU ohranijo, spremenijo, začasno prekličejo ali umaknejo.
English: To this effect the Committee recommended that treatment duration should be limited to a maximum of 15 days (packs were also limited to a two-week supply), that nimesulide should be restricted to second line treatment, and that doctors should be clearly informed of the risk.
Slovenian: Odbor je v ta namen priporočil, naj se čas zdravljenja omeji na največ 15 dni (tudi pakiranja so omejili na dvotedensko zalogo), naj se nimesulid uporablja šele kot zdravilo druge izbire in da naj bodo zdravniki jasno seznanjeni s tveganji.
English: The Committee reviewed available post marketing data from spontaneous reports of side effects, individual study reports and epidemiological (population-based) studies.
Slovenian: Odbor je pregledal razpoložljive podatke po začetku trženja iz spontanih poročil o neželenih učinkih, iz posameznih poročil o študijah in iz epidemioloških študij (ki temeljijo na prebivalstvu).
English: The Committee noted that the studies looking into the effectiveness of nimesulide in acute pain relief have shown that it is as effective as other NSAID pain killers such as diclofenac, ibuprofen and naproxen.
Slovenian: Odbor je opozoril, da so študije, ki so proučevale učinkovitost nimesulida pri lajšanju akutne bolečine, pokazale, da je enako učinkovit kot druga neselektivna nesteroidna protivnetna in protibolečinska zdravila, kot so diklofenak, ibuprofen in naproksen.
English: The review procedure was triggered by the decision of Ireland's medicines regulatory authority in May 2007 to suspend the marketing authorisation for systemic nimesulide-containing medicines, due to new information regarding cases of fulminant hepatic failure requiring liver transplantation.1 The Committee concluded that the benefits of systemic formulations of nimesulide still outweigh their risks, provided that the use of these medicines is restricted to ensure that the risk of patients developing liver problems is kept to a minimum.
Slovenian: Postopek pregleda je sprožil sklep irskega regulativnega organa za zdravila maja 2007, da se začasno prekliče dovoljenje za promet z zdravili, ki vsebujejo nimesulid, zaradi novih podatkov o primerih fulminantne odpovedi jeter, ki so zahtevali presaditev jeter.1 Odbor je zaključil, da koristi sistemskih formulacij, ki vsebujejo nimesulid, še vedno odtehtajo z njimi povezana tveganja, če je uporaba teh zdravil omejena tako, da so tveganja za nastanek težav z jetri pri bolnikih zmanjšana na najmanjšo možno mero.
English: • Prescribers should review treatment of patients being treated for painful osteoarthritis with a view to choosing an appropriate alternative treatment.
Slovenian: • Zdravniki naj pregledajo zdravljenje bolnikov, ki se zdravijo zaradi bolečega osteoartritisa z namenom, da jim izberejo ustrezno nadomestno zdravljenje.
English: To limit the risk of side effects affecting the liver, several restrictions have already been introduced in the past, including restriction to second line treatment, the use of lowest effective doses for the shortest possible duration, and a maximum duration of treatment for acute pain.
Slovenian: Da bi zmanjšali tveganje za nastanek neželenih učinkov, ki vplivajo na jetra, so v preteklosti že uvedli nekatere omejitve, vključno z omejitvijo, da se uporablja le kot zdravilo druge izbire, z uporabo najmanjših učinkovitih odmerkov za najkrajši možni čas in z določitvijo najdaljšega dovoljenega zdravljenja akutne bolečine.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of nimesulide used systemically continue to outweigh its risks but that its use should be restricted to the treatment of acute pain and primary dysmenorrhoea.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) Evropske agencije za zdravila je zaključil, da koristi nimesulida za sistemsko zdravljenje še vedno odtehtajo z njim povezana tveganja, vendar pa je treba njegovo uporabo omejiti na zdravljenje akutne bolečine in primarne dismenoreje.
English: The CHMP concluded that nimesulide was associated with an increased risk of liver toxicity compared with other anti-inflammatory treatments.
Slovenian: CHMP je zaključil, da je bil nimesulid povezan s povečanim tveganjem za toksične učinke na jetrih v primerjavi z drugimi protivnetnimi zdravljenji.