natgillin/translations-raw huggingface dataset:
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).
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).
Package leaflet
Bolezni živčevja
The Member States who raised concerns regarding the potential risk to animal health were Belgium, Denmark, France, Germany, Ireland, Italy, Portugal and Spain.
Nizozemska, Avstrija, Belgija, Danska, Finska, Francija, Nemčija, Grčija, Madžarska, Irska, Italija, Luksemburg, Norveška, Poljska, Portugalska in Španija.
Therefore, the relevance of the bibliographical data regarding Eqvalan to the test product cannot be confirmed.
Zato ustreznosti bibliografskih podatkov o zdravilu Eqvalan za testni izdelek ni mogoče potrditi.
The residue data provided was inadequate and the withdrawal period is therefore inadequately supported.
Predloženi podatki o ostanku so bili neustrezni, zato čas karence ni ustrezno utemeljen.
The CVMP recommended the refusal of the granting of the Marketing Authorisation and the suspension of the Marketing Authorisation for Equimectin where appropriate.
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.
The efficacy of the product for the treatment of endo- and ectoparasitic infections has not been demonstrated.
Učinkovitost izdelka za zdravljenje endo- in ektoparazitskih okužb ni bila dokazana.
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.
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.
The amended indication for the treatment of gastrointestinal endoparasitic infections in horses had not been demonstrated by the data provided.
Tudi spremenjene indikacije za zdravljenje gastrointestinalnih endoparazitskih okužb pri konjih predloženi podatki ne dokazujejo.
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.
Odbor je po presoji zadeve sklenil, da na osnovi razpoložljivih podatkov o zdravilu Equimectin bioekvivalenca z referenčnim izdelkom ni bila dokazana.
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.
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.
Equimectin 12mg/g oral gel for horses contains ivermectin.
En odmerek 0,2 mg ivermektina na kg telesne mase.
OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR EQUIMECTIN 12MG/G ORAL GEL FOR HORSES
Equimectin Peroralni gel mg/g
The Marketing Authorisation Holder was requested to substantiate the bioavailability/bioequivalence of the product, justifying the efficacy of the product.
Predložena je bila ena terenska raziskava, ki je utemeljevala učinkovitost izdelka.
COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP)
Farmacevtska oblika
European Medicines Agency Veterinary Medicines and Inspections
DODATEK I IME, FARMACEVTSKA OBLIKA, JAKOST ZDRAVILA, ŽIVALSKE VRSTE, NAČINI UPORABE IN IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
The CVMP during its meeting of May 2006 started a referral procedure under Article 33(4) of Directive 2001/82/EC as amended.
Relativno zmanjšanje števila jajčec rodu Strongylus v gramu iztrebkov za testni izdelek je bilo 3. dan 88,2 % in 8. dan 88,2 %.
The product is indicated for the treatment of endo- and ectoparasitic infections in horses, particularly gastrointestinal nematodes, dermal nematodes, lung nematodes and bots.
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.
The CVMP Opinion was adopted on 17 January 2007 and the subsequent Commission Decision on 2 April 2007.
Za jajčeca rodu Parascaris je bilo 3. dne zmanjšanje 50 %, 8. dan pa 65,2 %.
The European Commission issued a decision on this opinion on 29 November 2010.
Evropska komisija je odločbo v zvezi s tem mnenjem izdala 29. novembra 2010.
Outcome of a procedure under Article 107 of Directive 2001/83/EC
Rezultat postopka v skladu s členom 107 Direktive 2001/83/ES
Philippe Lechat (FR)
Philippe Lechat (Francija)
What are the recommendations for patients and healthcare professionals?
Kakšna so priporočila za bolnike in zdravstveno osebje?
Ondřej Slanař (CZ)
Ondřej Slanař (Češka republika)
Topical ketoprofen-containing medicines have been available in all Member States except for the Netherlands since 1978.
Zdravila, ki vsebujejo topični ketoprofen, so od leta 1978 na voljo v vseh državah članicah razen na Nizozemskem.
Blocking their production helps to reduce the signs of inflammation.
Preprečevanje njihovega nastanka pripomore k zmanjšanju znakov vnetja.
Why was topical ketoprofen reviewed?
Zakaj je bil topični ketoprofen pregledan?
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.
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.
Finally, the CHMP agreed to review the effectiveness of these risk minimization measures in three years time.
CHMP je sklenil, da se učinkovitost teh ukrepov za zmanjšanje tveganj pregleda po treh letih.
Ketoprofen is a non-steroidal anti-inflammatory drug (NSAID).
Ketoprofen je nesteroidno protivnetno zdravilo (NSAID).
They may be obtained with or without a prescription.
Izdajajo se na recept ali brez recepta.
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.
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.
• 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.
• bolniki morajo poskrbeti, da zdravljena področja zaščitijo pred sončno svetlobo ves čas zdravljenja s ketoprofenom in še dva tedna po prekinitvi zdravljenja.
• these medicines should no longer be available over the counter but should only be obtained with a prescription from a doctor;
• ta zdravila ne smejo več biti na voljo brez recepta, ampak se morajo izdajati le na zdravniški recept;
In addition, new skin reactions have been reported following use of products containing octocrylene.
Poleg tega so poročali o novih kožnih reakcijah zaradi uporabe zdravil, ki vsebujejo oktokrilen.
The European Medicines Agency has completed a review of the safety and effectiveness of ketoprofencontaining medicines used topically (on the skin).
Evropska agencija za zdravila je zaključila pregled varnosti in učinkovitosti zdravil, ki vsebujejo ketoprofen za topično uporabo (na koži).
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.
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.
In spite of these measures, new cases of photoallergy have been reported, which occurred even in cases of exposure to dim sunlight.
Kljub tem ukrepom so poročali o novih primerih fotoalergije, ki so se pojavili tudi ob izpostavitvi šibkejši sončni svetlobi.
• the risks of photoallergy with topical ketoprofen and the way to prevent it should be clearly communicated to healthcare professionals and to patients.
• tveganja fotoalergije zaradi topičnega ketoprofena in načine preprečevanja tega pojava je treba na jasen način sporočiti zdravstvenemu osebju in bolnikom.
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.
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.
Prostaglandins are messengers in the development of inflammation.
Prostaglandini so sporočilne molekule, prisotne pri razvoju vnetja.
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.
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.
• Doctors, pharmacists and patients should be aware of the risk of photoallergy with topical ketoprofen.
• zdravniki, farmacevti in bolniki se morajo zavedati tveganja fotoalergije pri uporabi topičnega ketoprofena;
Company responses provided on: 5 January 2010, 26 February 2010 and 7 June 2010 Opinion date:
5. januarja 2010, 26. februarja 2010 in 7. junija 2010
• Patients who have any questions should speak to their doctor or pharmacist.
• bolniki se lahko z vprašanji obrnejo na svojega zdravnika ali farmacevta.
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.
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.
They may be available as creams, gels, solutions, sprays and plasters under various trade names and as generics.
Na voljo so v obliki krem, gelov, raztopin, pršil in obližev, ki se tržijo pod različnimi tržnimi imeni in kot generična zdravila.
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).
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).
What is ketoprofen?
Kaj je zdravilo ketoprofen?
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.
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.
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.
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.
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.
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.
NSAIDs work by blocking an enzyme called cyclo-oxygenase, which is involved in the production of prostaglandins.
Nesteroidna protivnetna zdravila delujejo z blokiranjem encima, imenovanega ciklooksigenaza, ki sodeluje pri tvorbi prostaglandinov.
The CHMP concluded that the benefits of topical ketoprofen-containing medicines continue to outweigh their risks but recommended the following risk minimisation measures:
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:
• strengthened warnings on sun exposure should be included in the product information, as well as advice to stop using topical ketoprofen if any skin reactions develop, including when using ketoprofen together with octocrylene;
• v informacije o zdravilu je treba vključiti več opozoril o izpostavljanju soncu ter napotek o prenehanju uporabe topičnega ketoprofena v primeru pojava neželenih kožnih reakcij, vključno pri sočasni uporabi topičnega ketoprofena in oktokrilena;
• Doctors should tell their patients how to use topical ketoprofen-containing medicines appropriately.
• zdravniki morajo svojim bolnikom dati ustrezna navodila o uporabi topičnih zdravil, ki vsebujejo ketoprofen;
The Committee also noted that, although alternative topical NSAIDs are available in the EU, ketoprofen is the only topical NSAID authorised for the treatment of acute lowback pain.
Odbor je tudi ugotovil, da je ketoprofen edino topično nesteroidno protivnetno zdravilo, odobreno za zdravljenje akutne bolečine v križu, kljub razpoložljivosti alternativnih topičnih nesteroidnih protivnetnih zdravil v EU.
• Patients should discontinue treatment immediately if they develop any skin reaction after application of these medicines, and seek their doctor's advice.
• če se po uporabi opisanih zdravil pojavi kakršna koli kožna reakcija, morajo bolniki nemudoma prekiniti zdravljenje in se posvetovati z zdravnikom;
They should also wash their hands carefully after each application of ketoprofen.
Po vsakem nanosu ketoprofena si morajo temeljito umiti roke;
The European Commission issued a decision on 13 September 2011.
Evropska komisija je odločbo izdala dne 13. septembra 2011.
• Patients who have any questions should speak to their doctor.
• Bolniki, ki imajo kakršna koli vprašanja, naj se posvetujejo s svojim zdravnikom.
Medicines containing dexrazoxane are authorised for the prevention of cardiotoxic effects in Austria, Czech Republic, Germany, Denmark, Finland, France, Greece, Hungary, Ireland, Italy, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Slovakia Spain and the United Kingdom under the following invented names: Cardioxane, Cyrdanax, Dexrazoxane Cyathus, Enaxozar and Procard.
Zdravila, ki vsebujejo deksrazoksan, so odobrena za preprečevanje kardiotoksičnih učinkov v Avstriji, Češki republiki, Nemčiji, na Danskem, Finskem, v Franciji, Grčiji, na Madžarskem, Irskem, v Italiji, Litvi, Luksemburgu, na Nizozemskem, Norveškem, Poljskem, Portugalskem, v Romuniji, na Slovaškem, v Španiji in Združenem kraljestvu pod naslednjimi lastniškimi imeni: Cardioxane, Cyrdanax, Dexrazoxane Cyathus, Enaxozar in Procard.
EMA/CHMP/485343/2011 rev.1 EMEA/H/A-31/1275
EMA/773275/2011 rev. 1 EMEA/H/A-31/1275
What are the recommendations for patients and prescribers?
Kakšna so priporočila za zdravnike, ki predpisujejo zdravila, in bolnike?
The Committee also reviewed all available data on the safety and effectiveness of dexrazoxane, including published studies and data submitted by the companies that market the medicines.
Odbor je pregledal tudi vse razpoložljive podatke o varnosti in učinkovitosti deksrazoksana, vključno z objavljenimi študijami in podatki, ki so jih predložile družbe, ki tržijo zdravila.
The European Medicines Agency has completed a review of the safety and effectiveness of dexrazoxane.
Evropska agencija za zdravila je zaključila pregled varnosti in učinkovitosti deksrazoksana.
There was also an increased risk of severe myelosuppression (a condition in which the bone marrow cannot make enough blood cells) and severe infection.
Prisotno je bilo tudi povečano tveganje hude mielosupresije (stanja, pri katerem kostni mozeg ne uspe proizvesti zadostnega števila krvnih celic) in hudih okužb.
• Information on recommended dosing and additional information on the risks associated with dexrazoxane can be found in the updated prescribing information.
• Informacije o priporočenem odmerjanju in dodatne informacije o tveganjih, povezanih z deksrazoksanom, so na voljo v posodobljenih podatkih o predpisovanju zdravila.
The UK medicines regulatory agency also shared these concerns and asked the CHMP to carry out a full assessment of the benefit-risk balance of dexrazoxane and to issue an opinion on
Tudi regulativna agencija za zdravila v Združenem kraljestvu je izrazila te pomisleke in pozvala CHMP, naj izvede celovito oceno razmerja med koristmi in tveganji za
whether the marketing authorisations for products containing dexrazoxane should be maintained, varied, suspended or withdrawn across the European Union.
deksrazoksan ter izda mnenje o tem, ali se dovoljenja za promet z zdravili, ki vsebujejo deksrazoksan, v Evropski uniji ohranijo, spremenijo, začasno umaknejo ali umaknejo.
The Committee also noted that in one study in breast cancer patients, dexrazoxane was associated with worsened response to cancer therapy while other studies showed an increased risk of dying in the first few months of treatment with dexrazoxane at a dose ratio of 20: 1 (20 parts dexrazoxane for 1 part of doxorubicin).
Odbor je ugotovil tudi, da je deksrazoksan v eni študiji z bolnicami z rakom dojk poslabšal odziv na zdravljenje proti raku, medtem ko so druge študije pokazale povečano tveganje umrljivosti v prvih nekaj mesecih zdravljenja z deksrazoksanom v razmerju odmerka 20:1 (20 delov deksrazoksana proti 1 delu doksorubicina).
• Dexrazoxane should only be used in adult patients who have already received a minimum cumulative anthracycline dose of 300 mg/m2 of doxorubicin, or 540 mg/m2 of epirubicin.
• Deksrazoksan se lahko uporablja samo pri odraslih bolnicah, ki so že prejele minimalni kumulativni antraciklinski odmerek 300 mg/m2 doksorubicina ali 540 mg/m2 epirubicina.
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 toxic to the heart muscle.
Ni povsem jasno, kako deksrazoksan varuje srce, vendar je to verjetno povezano z načinom vezave zdravila na železove ione, ki sodelujejo v postopkih, zaradi katerih so antraciklini toksični za srčno mišico.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that dexrazoxane should not be used in children and adolescents.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji je zaključil, da se deksrazoksan ne sme uporabljati pri otrocih in mladostnikih.
In addition to the restriction in the medicine's use, the CHMP has recommended a reduced dose ratio of 10:1 with doxorubicin (the dose ratio remains 10:1 for epirubicin) in adults and has included in the SmPCs more information on what is currently known about the risks of dexrazoxane-containing medicine.
Poleg omejitve uporabe zdravila je CHMP priporočil zmanjšano razmerje odmerka 10:1 z doksorubicinom (razmerje med epirubicinom in doksorubicinom 10:1) pri odraslih ter v povzetek glavnih značilnosti zdravila vključil več informacij o tveganjih pri zdravilih, ki vsebujejo deksrazoksan.
The CHMP concluded that the benefits of dexrazoxanecontaining medicines do not outweigh its risk in children and adolescents, and the medicine should not be used in these age-groups.
CHMP je zaključil, da koristi zdravil, ki vsebujejo deksrazoksan, ne odtehtajo z njim povezanih tveganj pri otrocih in mladostnikih, zato se zdravilo v tej starostni skupini ne sme uporabljati.
What is dexrazoxane?
Kaj je deksrazoksan?
The Committee noted that there was evidence of serious harm in children receiving dexrazoxane.
Odbor je opozoril, da obstajajo dokazi hudih škodljivih vplivov pri otrocih, ki prejemajo deksrazoksan.
• When deciding whether to use dexrazoxane prescribers should consider the short- and long-term risks associated with this product (e.g. myelosuppression and the potential for AML), alongside possible benefits in relation to protection of the heart.
• Pri odločanju glede uporabe deksrazoksana morajo zdravniki, ki predpisujejo zdravilo, ob možnih koristih za zaščito srca preučiti tudi kratkoročna in dolgoročna tveganja, povezana z zdravilom (npr. mielosupresija in možnost za akutno mieloidno levkemijo).
The Committee has also made recommendations for changes to the summaries of product characteristics (SmPCs) for dexrazoxanecontaining medicines.
Odbor je tudi podal priporočila za spremembe povzetkov glavnih značilnosti zdravil, ki vsebujejo deksrazoksan.
Why was dexrazoxane reviewed?
Zakaj je bil deksrazoksan pregledan?
Dexrazoxane is used in patients with cancer to prevent long-tem toxic effects on the heart caused by treatment with the anticancer medicines doxorubicin and epirubicin.
Deksrazoksan se uporablja pri bolnikih z rakom za preprečevanje dolgoročnih toksičnih učinkov na srce, ki nastanejo zaradi zdravljenja z zdraviloma proti raku doksorubicinom in epirubicinom.
The French medicines regulatory agency raised concerns that dexrazoxane could be linked to an increased risk of two cancers: acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS).
Francoska regulativna agencija za zdravila je izrazila pomisleke, da utegne deksrazoksan vplivati na povečano tveganje dveh vrst raka: akutna mieloidna levkemija in mielodisplastični sindrom.
The use of dexrazoxane should be restricted to adult patients with advanced or metastatic breast cancer who have already received a certain amount of doxorubicin and epirubicin.
Uporabo deksrazoksana je treba omejiti na odrasle bolnice z napredovalim ali metastatičnim rakom dojk, ki so že prejele ustrezno količino doksorubicina in epirubicina.
• Dexrazoxane should only be used in adult patients with advanced or metastatic breast cancer.
• Deksrazoksan se lahko uporablja samo pri odraslih bolnicah z napredovalim ali metastatskim rakom dojk.