FrancophonIA/ELRC3.0 huggingface dataset:
English: Following the administration of a double dose of vaccine, no side-effects other than those described under section 4.6 have been observed.
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Dvojni odmerek cepiva ni povzročil neželenih učinkov, ki bi se razlikovali od tistih, opisanih v poglavju 4.6. 4.11 Karenca
English: 1 ml vial, 1 ml pre-filled syringe
Slovenian: Viala po 1 ml, napolnjena injekcijska brizga po 1ml
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))
Slovenian: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali)
English: Name and address of the manufacturer of the biological active substance
Slovenian: Ime in naslov proizvajalca(proizvajalcev) biološke(bioloških) učinkovine (učinkovin) Intervet International B.V.
English: Plastic box with 5 or 10 pre-filled syringes of 1 ml (1 dose).
Slovenian: Plastična škatla s 5 ali 10 napolnjenimi injekcijskimi brizgami po 1 ml (1 odmerek).
English: Cardboard box with 5 or 10 pre-filled syringes of 1 ml (1 dose).
Slovenian: Kartonska škatla s 5 ali 10 napolnjenimi injekcijskimi brizgami po 1 ml (1 odmerek).
English: Sodium chloride
Slovenian: prečiščeni saponin
English: IM
Slovenian: NALEPKA
English: Phosphatidylcholine
Slovenian: 83 mikrogramov fosfatildiholin
English: Plastic box with 10 glass vials of 1 ml (1 dose).
Slovenian: Plastična škatla z 10 steklenimi vialami po 1 ml (1 odmerek).
English: Cardboard box with 10 glass vials of 1 ml (1 dose).
Slovenian: Kartonska šlatla z 10 steklenimi vialami po 1 ml (1 odmerek).
English: Cholesterol
Slovenian: KARENCA
English: Potassium chloride
Slovenian: Brejost in laktacija:
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 1 ml (1 dose)
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Slovenian: Pred uporabo preberite navodilo za uporabo.
English: Capsule, hard blister (alu/PVC) 42 capsules
Slovenian: Peroralna uporaba pretisni omot (alu/PVC) 42 kapsul
English: Strength Pharmaceutical Form Route of Administration
Slovenian: Številka EU Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
English: 50 mg
Slovenian: 600 mg Filmsko obložena tableta Peroralna uporaba plastenka (HDPE)
English: What you need to know before you take CHAMPIX
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo CHAMPIX
English: Adopted at the 11-14 June 2018 PRAC
Slovenian: Sprejeto na seji odbora PRAC med 11. in 14. junijem 2018
English: Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first two months of treatment.
Slovenian: Zdi se, da te reakcije bolnike najbolj ogrožajo zgodaj v poteku zdravljenja, saj se reakcija večinoma pojavi v prvih dveh mesecih zdravljenja.
English: Varenicline - Loss of consciousness (EPITT no 19146)
Slovenian: Vareniklin - izguba zavesti (EPITT št. 19146)
English: At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions.
Slovenian: Ko se zdravilo predpiše, je treba bolnikom svetovati glede znakov in simptomov ter jih skrbno spremljati glede kožnih reakcij.
English: If signs and symptoms suggestive of these reactions appear, nabumetone should be withdrawn immediately and an alternative treatment considered (as appropriate).
Slovenian: Če se pojavijo znaki in simptomi, ki kažejo na te reakcije, je treba zdravljenje z nabumetonom takoj prekiniti in razmisliti o drugi vrsti zdravljenja (kot je ustrezno).
English: Effects on ability to drive and use machines
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev
English: Stop using <medicine> if you develop these symptoms and contact your doctor or seek medical attention immediately.
Slovenian: Če se pri vas pojavijo ti simptomi, prenehajte uporabljati <zdravilo> in se takoj posvetujte z zdravnikom ali poiščite zdravniško pomoč.
English: Nabumetone should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.
Slovenian: Zdravljenje z nabumetonom je treba prekiniti ob prvem pojavu kožnega izpuščaja, sluzničnih lezij ali katerega koli drugega znaka preobčutljivosti.
English: You should not drive, operate complex machinery or engage in any other potentially hazardous activities until you know whether this medicine affects your ability to perform these activities.
Slovenian: Ne vozite, ne upravljajte zapletenih strojev in ne opravljajte drugih morebitno nevarnih dejavnosti, dokler ne veste, ali to zdravilo vpliva na vašo sposobnost za te dejavnosti.
English: If the patient has developed a serious reaction such as SJS, TEN or DRESS with the use of nabumetone, treatment with nabumetone must not be restarted in this patient at any time.
Slovenian: Če je pri bolniku zaradi uporabe nabumetona prišlo do hude kožne reakcije, kot so SJS, TEN in DRESS, se zdravljenje z nabumetonom pri tem bolniku ne sme nikoli več ponovno začeti.
English: Not known Transient loss of consciousness
Slovenian: Neznana pogostnost Prehodna izguba zavesti
English: Patients are advised not to drive, operate complex machinery or engage in other potentially hazardous activities until it is known whether this medicinal product affects their ability to perform these activities.
Slovenian: Bolniki naj ne vozijo, ne upravljajo zapletenih strojev in ne opravljajo drugih možnih nevarnih dejavnosti, dokler ni znano, ali to zdravilo vpliva na njihovo sposobnost za te dejavnosti.
English: Nabumetone - Drug reaction with eosinophilia and systemic symptoms (DRESS)(EPITT no 19241)
Slovenian: Nabumeton - reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS)(EPITT št. 19241)
English: CHAMPIX may cause dizziness, somnolence and transient loss of consciousness, and therefore may influence the ability to drive and use machines.
Slovenian: Zdravilo CHAMPIX lahko povzroči omotico, zaspanost in prehodno izgubo zavesti ter lahko tako vpliva na sposobnost vožnje in upravljanja strojev.
English: CHAMPIX may be linked with produce dizziness, sleepiness and transient loss of consciousness.
Slovenian: Zdravilo CHAMPIX je lahko povezano zpovzroči omotico, zaspanostjo in začasno izgubo zavesti.
English: Possible side effects - Not known o Transient loss of consciousness
Slovenian: Možni neželeni učinki - Neznana pogostnost o Začasna izguba zavesti
English: CHAMPIX may have minor or moderate influence on the ability to drive and use machines.
Slovenian: Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo CHAMPIX ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja strojev.
English: Very rare: Bullous reactions including toxic epidermal necrolysis, Stevens Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, erythema multiforme, angioedema, pseudoporphyria, alopecia
Slovenian: Zelo redki: bulozne reakcije, vključno s toksično epidermalno nekrolizo, Stevens-Johnsonovim sindromom, reakcijo na zdravilo z eozinofilijo in sistemskimi simptomi, multiformnim eritemom, angioedemom, psevdoporfirijo in alopecijo.
English: Widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (drug reaction with eosinophilia and systemic symptoms which is also known as DRESS or drug hypersensitivity syndrome).
Slovenian: Razširjen izpuščaj, visoka telesna temperatura, zvišani jetrni encimi, nepravilnosti krvi (eozinofilija), povečane bezgavke in prizadetost drugih telesnih organov (reakcija na zdravilo z eozinofilijo in sistemskimi simptomi, znana tudi kot DRESS ali sindrom preobčutljivosti za zdravilo).
English: Undesirable effects Nervous system disorders
Slovenian: Preglednica neželenih učinkov
English: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported very rarely in association with the use of NSAIDs, including nabumetone (see section 4.8).
Slovenian: V povezavi z uporabo nesteroidnih protivnetnih zdravil, vključno z nabumetonom so zelo redko poročali o resnih kožnih reakcijah, nekaterih od njih smrtnih, vključno z eksfoliativnim dermatitisom, Stevens-Johnsonovim sindromom (SJS), toksično epidermalno nekrolizo (TEN) ter reakcijo na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS), ki so lahko življenjsko nevarni ali smrtni (glejte poglavje 4.8).
English: Severe cutaneous adverse reactions (SCARs), including exfoliative dermatitis, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with nabumetone treatment (see section 4.4).
Slovenian: V povezavi z zdravljenjem z nabumetonom so poročali o hudih kožnih neželenih učinkih, vključno z eksfoliativnim dermatitisom, Stevens-Johnsonovim sindromom (SJS), toksično epidermalno nekrolizo (TEN) ter reakcijo na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS) (glejte poglavje 4.4).
English: Package leaflet
Slovenian: Bolezni živčevja
English: The Member States who raised concerns regarding the potential risk to animal health were Belgium, Denmark, France, Germany, Ireland, Italy, Portugal and Spain.
Slovenian: Nizozemska, Avstrija, Belgija, Danska, Finska, Francija, Nemčija, Grčija, Madžarska, Irska, Italija, Luksemburg, Norveška, Poljska, Portugalska in Španija.
English: Therefore, the relevance of the bibliographical data regarding Eqvalan to the test product cannot be confirmed.
Slovenian: Zato ustreznosti bibliografskih podatkov o zdravilu Eqvalan za testni izdelek ni mogoče potrditi.
English: The residue data provided was inadequate and the withdrawal period is therefore inadequately supported.
Slovenian: Predloženi podatki o ostanku so bili neustrezni, zato čas karence ni ustrezno utemeljen.
English: The CVMP recommended the refusal of the granting of the Marketing Authorisation and the suspension of the Marketing Authorisation for Equimectin where appropriate.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je priporočil zavrnitev podelitve dovoljenja za promet in umik dovoljenja za promet za zdravilo Equimectin, kjer je ustrezno.
English: The efficacy of the product for the treatment of endo- and ectoparasitic infections has not been demonstrated.
Slovenian: Učinkovitost izdelka za zdravljenje endo- in ektoparazitskih okužb ni bila dokazana.
English: During the referral procedure, it was established that the submitted bioequivalence study was inadequate to demonstrate bioequivalence (as defined in current guidance EMEA/CVMP/016/00-corr- FINAL); however, from the comparative pharmacokinetic data it is possible that the test product is systemically less bioavailable than the reference product.
Slovenian: Med postopkom napotitve je bilo ugotovljeno, da predložena bioekvivalenčna raziskava ni ustrezna, da bi lahko dokazala bioekvivalenco (kot jo določa veljavna smernica EMEA/CVMP/016/00-corrFINAL), vendar pa je glede na primerjalne farmakokinetične podatke mogoče, da je testni izdelek sistemsko biološko manj uporaben od referenčnega izdelka.
English: The amended indication for the treatment of gastrointestinal endoparasitic infections in horses had not been demonstrated by the data provided.
Slovenian: Tudi spremenjene indikacije za zdravljenje gastrointestinalnih endoparazitskih okužb pri konjih predloženi podatki ne dokazujejo.
English: The Committee, having considered the matter, concluded that on the basis of the available data for Equimectin, bioequivalence with the reference product had not been shown.
Slovenian: Odbor je po presoji zadeve sklenil, da na osnovi razpoložljivih podatkov o zdravilu Equimectin bioekvivalenca z referenčnim izdelkom ni bila dokazana.
English: The documentation submitted with this application consisted of literature referring to the use of the originator product Eqvalan, a comparative pharmacokinetic study using Equimectin and Eqvalan, and a supplementary clinical field study.
Slovenian: Dokumentacija, ki je bila predložena s to vlogo, obsega literaturo v zvezi z uporabo originatorskega izdelka Eqvalan, primerjalno farmakokinetično raziskavo zdravil Equimectin in Eqvalan ter dodatno klinično terensko raziskavo.
English: Equimectin 12mg/g oral gel for horses contains ivermectin.
Slovenian: En odmerek 0,2 mg ivermektina na kg telesne mase.
English: OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR EQUIMECTIN 12MG/G ORAL GEL FOR HORSES
Slovenian: Equimectin Peroralni gel mg/g
English: The Marketing Authorisation Holder was requested to substantiate the bioavailability/bioequivalence of the product, justifying the efficacy of the product.
Slovenian: Predložena je bila ena terenska raziskava, ki je utemeljevala učinkovitost izdelka.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP)
Slovenian: Farmacevtska oblika
English: European Medicines Agency Veterinary Medicines and Inspections
Slovenian: DODATEK I IME, FARMACEVTSKA OBLIKA, JAKOST ZDRAVILA, ŽIVALSKE VRSTE, NAČINI UPORABE IN IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: The CVMP during its meeting of May 2006 started a referral procedure under Article 33(4) of Directive 2001/82/EC as amended.
Slovenian: Relativno zmanjšanje števila jajčec rodu Strongylus v gramu iztrebkov za testni izdelek je bilo 3. dan 88,2 % in 8. dan 88,2 %.
English: The product is indicated for the treatment of endo- and ectoparasitic infections in horses, particularly gastrointestinal nematodes, dermal nematodes, lung nematodes and bots.
Slovenian: Ni primerno, da SPC antiparazitika za konje navaja uporabo izdelka samo proti 5 specifičnim zajedavcem, med katerimi ni za konje pomembnega rodu Strongylus, pri čemer pa iz drugih navedb izhaja, da je izdelek učinkovit proti širši populaciji zajedavcev.
English: The CVMP Opinion was adopted on 17 January 2007 and the subsequent Commission Decision on 2 April 2007.
Slovenian: Za jajčeca rodu Parascaris je bilo 3. dne zmanjšanje 50 %, 8. dan pa 65,2 %.
English: The European Commission issued a decision on this opinion on 29 November 2010.
Slovenian: Evropska komisija je odločbo v zvezi s tem mnenjem izdala 29. novembra 2010.
English: Outcome of a procedure under Article 107 of Directive 2001/83/EC
Slovenian: Rezultat postopka v skladu s členom 107 Direktive 2001/83/ES
English: Philippe Lechat (FR)
Slovenian: Philippe Lechat (Francija)
English: What are the recommendations for patients and healthcare professionals?
Slovenian: Kakšna so priporočila za bolnike in zdravstveno osebje?
English: Ondřej Slanař (CZ)
Slovenian: Ondřej Slanař (Češka republika)
English: Topical ketoprofen-containing medicines have been available in all Member States except for the Netherlands since 1978.
Slovenian: Zdravila, ki vsebujejo topični ketoprofen, so od leta 1978 na voljo v vseh državah članicah razen na Nizozemskem.
English: Blocking their production helps to reduce the signs of inflammation.
Slovenian: Preprečevanje njihovega nastanka pripomore k zmanjšanju znakov vnetja.
English: Why was topical ketoprofen reviewed?
Slovenian: Zakaj je bil topični ketoprofen pregledan?
English: The CHMP looked into all the available safety data, including data from member states' databases and data provided by the companies marketing topical ketoprofen in the EU.
Slovenian: CHMP je pregledal vse razpoložljive podatke, vključno s podatki iz podatkovnih zbirk držav članic ter podatki, ki so jih posredovale družbe, ki tržijo topični ketoprofen v EU.
English: Finally, the CHMP agreed to review the effectiveness of these risk minimization measures in three years time.
Slovenian: CHMP je sklenil, da se učinkovitost teh ukrepov za zmanjšanje tveganj pregleda po treh letih.
English: Ketoprofen is a non-steroidal anti-inflammatory drug (NSAID).
Slovenian: Ketoprofen je nesteroidno protivnetno zdravilo (NSAID).
English: They may be obtained with or without a prescription.
Slovenian: Izdajajo se na recept ali brez recepta.
English: As required by Article 107, the French agency informed the CHMP of its actions so that the Committee could prepare an opinion on whether the marketing authorisations for topical products containing ketoprofen should be maintained, changed, suspended or revoked across the EU.
Slovenian: Francoska agencija je skladno z določili člena 107 obvestila CHMP o svojih ukrepih, da bi lahko odbor pripravil mnenje o tem, ali se v celotni EU dovoljenja za promet s topičnimi zdravili, ki vsebujejo ketoprofen, ohranijo, spremenijo, začasno umaknejo ali prekličejo.
English: • Patients should make sure that the treated areas are protected from sunlight during the whole period of ketoprofen treatment and the two weeks after stopping the treatment.
Slovenian: • bolniki morajo poskrbeti, da zdravljena področja zaščitijo pred sončno svetlobo ves čas zdravljenja s ketoprofenom in še dva tedna po prekinitvi zdravljenja.
English: • these medicines should no longer be available over the counter but should only be obtained with a prescription from a doctor;
Slovenian: • ta zdravila ne smejo več biti na voljo brez recepta, ampak se morajo izdajati le na zdravniški recept;
English: In addition, new skin reactions have been reported following use of products containing octocrylene.
Slovenian: Poleg tega so poročali o novih kožnih reakcijah zaradi uporabe zdravil, ki vsebujejo oktokrilen.
English: The European Medicines Agency has completed a review of the safety and effectiveness of ketoprofencontaining medicines used topically (on the skin).
Slovenian: Evropska agencija za zdravila je zaključila pregled varnosti in učinkovitosti zdravil, ki vsebujejo ketoprofen za topično uporabo (na koži).
English: In December 2009, after re-assessing these medicines, the French agency considered that their benefit-risk balance was no longer positive and decided to suspend the marketing authorisations of all topical medicines containing ketoprofen in France.
Slovenian: Decembra 2009 je francoska agencija na podlagi ponovnega vrednotenja teh zdravil menila, da njihovo razmerje med tveganji in koristmi ni več pozitivno, in se je odločila za začasen umik dovoljenj za promet za vsa topična zdravila v Franciji, ki vsebujejo ketoprofen.
English: In spite of these measures, new cases of photoallergy have been reported, which occurred even in cases of exposure to dim sunlight.
Slovenian: Kljub tem ukrepom so poročali o novih primerih fotoalergije, ki so se pojavili tudi ob izpostavitvi šibkejši sončni svetlobi.
English: • the risks of photoallergy with topical ketoprofen and the way to prevent it should be clearly communicated to healthcare professionals and to patients.
Slovenian: • tveganja fotoalergije zaradi topičnega ketoprofena in načine preprečevanja tega pojava je treba na jasen način sporočiti zdravstvenemu osebju in bolnikom.
English: As a result, measures to reduce harm were implemented in France, such as the inclusion of warnings and precautions in the French product information, a pictogram on the packaging and dissemination of letters to healthcare professionals.
Slovenian: Posledično so bili v Franciji uvedeni ukrepi za zmanjšanje škode, kot so vključitev opozoril in previdnostnih ukrepov v francoske informacije o zdravilu, piktogram na ovojnini in obveščanje zdravstvenih delavcev.
English: Prostaglandins are messengers in the development of inflammation.
Slovenian: Prostaglandini so sporočilne molekule, prisotne pri razvoju vnetja.
English: The CHMP noted that the number of reports of adverse skin reactions including photoallergy is low throughout the EU and that the risk of these side effects could potentially be reduced using appropriate minimisation measures.
Slovenian: CHMP je ugotovil, da je število poročil o neželenih kožnih reakcijah, vključno s fotoalergijo, po celi EU nizko in da se lahko tveganje teh neželenih učinkov zmanjša z ustreznimi ukrepi.
English: • Doctors, pharmacists and patients should be aware of the risk of photoallergy with topical ketoprofen.
Slovenian: • zdravniki, farmacevti in bolniki se morajo zavedati tveganja fotoalergije pri uporabi topičnega ketoprofena;
English: Company responses provided on: 5 January 2010, 26 February 2010 and 7 June 2010 Opinion date:
Slovenian: 5. januarja 2010, 26. februarja 2010 in 7. junija 2010
English: • Patients who have any questions should speak to their doctor or pharmacist.
Slovenian: • bolniki se lahko z vprašanji obrnejo na svojega zdravnika ali farmacevta.
English: Since their marketing authorisation, the French medicines regulatory agency (Afssaps) has reviewed the safety of topical ketoprofen-containing medicines several times because of reports of photoallergy (allergic reactions to a medicine following exposure to sunlight) in patients using these medicines.
Slovenian: Po pridobitvi dovoljenja za promet je francoska regulativna agencija za zdravila (Afssaps) večkrat pregledala varnost topičnih zdravil, ki vsebujejo ketoprofen, zaradi poročil o fotoalergiji (alergijskih reakcijah na zdravilo po izpostavitvi sončni svetlobi) pri bolnikih, ki so uporabili ta zdravila.
English: They may be available as creams, gels, solutions, sprays and plasters under various trade names and as generics.
Slovenian: Na voljo so v obliki krem, gelov, raztopin, pršil in obližev, ki se tržijo pod različnimi tržnimi imeni in kot generična zdravila.
English: Topical formulations of ketoprofen are used to treat the symptoms of pain and inflammation in conditions such as minor trauma (sprains, bruising), tendonitis (inflammation of a tendon), small-joint osteoarthritis (swelling and pain in the small joints), acute low-back pain and phlebitis (inflammation of a vein).
Slovenian: Topične formulacije ketoprofena se uporabljajo za zdravljenje simptomov bolečine in vnetja pri stanjih, kot so manjše poškodbe (izpahi, podplutbe), tendonitis (vnetje tetive), osteoartritis majhnih sklepov (otekanje in bolečine v majhnih sklepih), akutne bolečine v križu in flebitis (vnetje vene).
English: What is ketoprofen?
Slovenian: Kaj je zdravilo ketoprofen?
English: Octocrylene is a chemical sunscreen found in several cosmetics and care products such as shampoo, skin creams, anti-ageing creams, make-up removers and hair sprays.
Slovenian: Oktokrilen je kemična snov za zaščito kože pred soncem, ki jo vsebujejo številni kozmetični in negovalni proizvodi, kot so šamponi, kreme za kožo, kreme proti staranju, odstranjevalci ličil in pršila za lase.
English: In particular, the Committee considered the responses given by the companies to a list of questions on photosensitivity reactions, including photoallergy, in patients using these medicines.
Slovenian: CHMP je obravnaval zlasti odgovore, ki so jih družbe podale na vprašanja o reakcijah preobčutljivosti na svetlobo, vključno s fotoalergijo, pri bolnikih, ki so uporabljali ta zdravila.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of topical ketoprofen continue to outweigh its risks, but that further measures should be put in place to minimise the risk of adverse skin reactions.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da koristi topičnega ketoprofena še vedno odtehtajo njegova tveganja in da je treba vzpostaviti dodatne ukrepe za zmanjšanje tveganja neželenih kožnih reakcij.
English: NSAIDs work by blocking an enzyme called cyclo-oxygenase, which is involved in the production of prostaglandins.
Slovenian: Nesteroidna protivnetna zdravila delujejo z blokiranjem encima, imenovanega ciklooksigenaza, ki sodeluje pri tvorbi prostaglandinov.
English: The CHMP concluded that the benefits of topical ketoprofen-containing medicines continue to outweigh their risks but recommended the following risk minimisation measures:
Slovenian: CHMP je zaključil, da koristi topičnih zdravil, ki vsebujejo ketoprofen, še vedno odtehtajo z njimi povezana tveganja, vendar je priporočil naslednje ukrepe za zmanjšanje tveganj: