FrancophonIA/ELRC3.0 huggingface dataset:
English: added to 50 mg atenolol (o.d.) for 8 weeks produced a significant increase (+34.4s, p=0.03) in the time to 1-mm ST-segment depression in exercise tests, in a subgroup of patients (n=173), when compared to placebo, 12 hours after taking the drug.
Slovenian: V randomizirani, dvojno slepi, s placebom nadzorovani študiji pri 223 bolnikih (Sellier) je ena tableta s prirejenim sproščanjem s 35 mg trimetazidina (dvakrat dnevno) poleg 50 mg atenolola (enkrat dnevno) pri podskupini bolnikov (N=173) v 8 tednih povzročila značilno podaljšanje (+34,4 s, p = 0,03) časa do nastopa za 1 mm znižane veznice ST med obremenitvenim testom v primerjavi s placebom, 12 ur po jemanju zdravila.
English: 4.7 Effects on ability to drive and use machines [the currently approved wording of this section should be deleted and replaced by the following]
Slovenian: [trenutno odobreno besedilo v tem poglavju je treba izbrisati ter ga nadomestiti z naslednjim]
English: Member State EU/EEA
Slovenian: Država članica EU/EGP
English: The reference Member State is the United Kingdom.
Slovenian: Referenčna država članica je Združeno kraljestvo.
English: Direct therapeutic benefit
Slovenian: Neposredna terapevtska korist
English: The concerned Member States involved are Germany and the Netherlands.
Slovenian: Zadevni državi članici v postopku sta Nemčija in Nizozemska.
English: Northern Ireland
Slovenian: Severna Irska
English: No additional studies were carried out in order to further refine the risk as guidance in this area is not currently available.
Slovenian: Dodatnih študij, s katerimi bi podrobneje opredelili to tveganje, niso opravili, saj navodila na tem področju trenutno niso na voljo.
English: 4.5 Special precautions for use iii.
Slovenian: 4.5 Posebni previdnostni ukrepi iii.
English: Assessment of the data submitted
Slovenian: Ocena predloženih podatkov
English: The ERA was full and complete in terms of data requirements.
Slovenian: OTO je bila z vidika zahtevanih podatkov celovita in popolna.
English: Quality, target animal safety, user safety, residues and resistance were not assessed in this referral procedure, but all risks were addressed during the decentralised procedure.
Slovenian: Kakovosti, varnosti zdravila za ciljno živalsko vrsto, varnosti za uporabnika, ostankov in odpornosti v okviru tega napotitvenega postopka niso ocenjevali, so pa vsa tveganja obravnavali med decentraliziranim postopkom.
English: Other precautions
Slovenian: Drugi previdnostni ukrepi
English: The active substance is well known and is included in veterinary medicinal products currently authorised in the EU for use in cattle.
Slovenian: Ta zdravilna učinkovina je dobro znana in je prisotna v zdravilih za uporabo v veterinarski medicini, ki so trenutno odobrena v EU za uporabo pri govedu.
English: Risk management or mitigation measures
Slovenian: Ukrepi za obvladovanje ali zmanjšanje tveganja
English: The benefit-risk for the product can be considered to be positive.
Slovenian: Razmerje med tveganji in koristmi zdravila se lahko oceni kot pozitivno.
English: Name
Slovenian: Ime
English: It provided all the information required to be able to make a conclusion on the environmental risk presented by the use of this product.
Slovenian: Ocena je zagotovila vse podatke, ki so bili potrebni za sprejetje zaključkov o tveganju za okolje, ki ga predstavlja uporaba tega zdravila.
English: Like other macrocyclic lactones, eprinomectin has the potential to adversely affect non-target organisms.
Slovenian: Tako kot drugi makrociklični laktoni, lahko ima eprinomektin neželene učinke pri neciljnih organizmih.
English: 5.3 Environmental properties
Slovenian: 5.3 Okoljski podatki
English: The valid Summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination Group procedure with the following amendments:
Slovenian: Veljavni Povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so zadnje različice, ki so bile pripravljene v postopku koordinacijske skupine, z naslednjimi spremembami:
English: The amended summary of product characteristics and package leaflet of the reference Member State are set out in Annex III.
Slovenian: Spremenjeni povzetek glavnih značilnosti zdravila in navodilo za uporabo referenčne države članice sta opredeljena v Prilogi III.
English: Eprinomectin residues will be introduced into the environment following direct excretion onto pasture.
Slovenian: Ostanki eprinomektina bodo v okolje vneseni po neposrednem izločanju na pašnik.
English: Considering the data submitted, the Committee concluded as follows on issues raised in the notification received from Germany.
Slovenian: Po proučitvi predloženih podatkov je odbor glede vprašanj, ki jih je v uradnem obvestilu poslala Nemčija, podal zaključke, ki so navedeni v nadaljevanju.
English: Eprinomectin has a n-octanol/water partition coefficient (KOW, expressed as log KOW) of 6.5 which was tested in a valid KOW study according to guideline 117 of the Organisation for Economic Co-operation and Development (OECD)4.
Slovenian: Eprinomektin ima porazdelitveni koeficient n-oktanol/voda (KOW, izražen kot log KOW), ki znaša 6,5, kar so preverili v veljavni študiji KOW v skladu s smernicami 117 Organizacije za gospodarsko sodelovanje in razvoj (OECD)4.
English: In conclusion eprinomectin was not considered to be a PBT compound.
Slovenian: Posledično so zaključili, da eprinomektin ni snov PBT.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration, applicant in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravil za uporabo v veterinarski medicini, živalske vrste, pot uporabe, vlagatelj v državi članici
English: Evaluation of secondary poisoning showed the risk quotient values for terrestrial and aquatic predators were <1 and further assessment was not required.
Slovenian: Ocena možnosti sekundarne zastrupitve je pokazala, da so vrednosti količnika tveganja za zemeljske in vodne plenilce manj kot 1, zato nadaljnje ocene niso bile potrebne.
English: Strength Pharmaceutical form
Slovenian: Jakost FARMACEVTSKA OBLIKA
English: Risk assessment
Slovenian: Ocena tveganja
English: Add the following text in the relevant sections of the product information:
Slovenian: V zadevna poglavja informacij o zdravilu se doda naslednje besedilo:
English: The risk to aquatic ecosystems and dung fauna can be reduced by avoiding too frequent and repeated use of eprinomectin (and products of the same anthelmintic class) in cattle.
Slovenian: Tveganje za vodne ekosisteme in v iztrebkih živeče organizme zmanjšamo z izogibanjem prepogosti in ponavljajoči se uporabi eprinomektina (in antihelmintikov istega razreda) pri govedu.
English: Potential serious risks were identified during the decentralised procedure by Germany who considered that eprinomectin might potentially be a PBT (persistent, bioaccumulative and toxic) substance.
Slovenian: Med decentraliziranim postopkom je Nemčija ugotovila možnost resnega tveganja, saj je menila, da bi eprinomektin lahko bil snov, ki je obstojna, strupena in se lahko kopiči v organizmih (persistent, bioaccumulative and toxic - PBT).
English: Results from a bioaccumulation study according to OECD guideline 3055 demonstrate that eprinomectin is not likely to concentrate to levels that would pose a risk to aquatic organisms.
Slovenian: Rezultati študije o kopičenju v organizmih, skladne s smernicami OECD 3055, kažejo, da ni verjetno, da bi koncentracija eprinomektina postala tako velika, da bi predstavljala tveganje za vodne organizme.
English: An ERA in accordance with VICH and CVMP guidelines was provided which contained a mixture of published and bespoke studies from the applicant and addressed all aspects of environmental risk.
Slovenian: Predložena je bila ocena tveganja za okolje, skladna s smernicami VICH in odbora CVMP, ki je vsebovala objavljene študije in študije po naročilu predlagatelja ter je obravnavala vse vidike tveganja za okolje.
English: Germany Norbrook Laboratories Limited
Slovenian: Nemčija Norbrook Laboratories Limited
English: In order to address the concerns raised by the referral, the applicant provided an environmental risk assessment (ERA) in accordance with VICH guidelines GL61 and GL382 and in accordance with the CVMP guideline in support of VICH guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005)3.
Slovenian: Da bi odpravil zadržke, zaradi katerih je bil sprožen napotitveni postopek, je predlagatelj predložil oceno tveganja za okolje (OTO), skladno s smernicami VICH GL61 in GL382 ter smernicami odbora CVMP v podporo smernicam VICH GL6 in GL38 (EMEA/CVMP/ERA/418282/2005)3.
English: A screening for PBT properties as required by the CVMP guidelines indicated that eprinomectin fulfils the criteria for 'P' and 'T' but it was considered not to be 'B'.
Slovenian: Pregled za ugotavljanje lastnosti PBT v skladu z zahtevami smernic odbora CVMP je pokazal, da eprinomektin izpolnjuje kriterije za „P“ in „T“, ne pa tudi za „B“.
English: The benefit of the products is treatment and control of infections from gastrointestinal roundworms (adults and fourth stage larvae), lungworms (adults and fourth stage larvae), warbles (parasitic stages, mange mites, lice and horn flies by using this product.
Slovenian: Uporaba tega zdravila je koristna za zdravljenje in nadzorovanje okužb z želodčno-črevesnimi glistami (odraslimi in ličinkami v četrti fazi razvoja), pljučnimi črvi (odraslimi in ličinkami v četrti fazi razvoja), govejimi zolji (v parazitskem stadiju), garjami, ušmi in muhami Haematobia irritans.
English: The application in question, submitted via the decentralised procedure, is a ‘hybrid' application according to Art. 13(3) of Directive 2001/82/EC, as amended, referring to the reference product Eprinex Pour-On Solution for Beef and Dairy Cattle authorised in the United Kingdom.
Slovenian: Obravnavana vloga, predložena po decentraliziranem postopku, je v skladu s členom 13(3) Direktive 2001/82/ES, kakor je bila spremenjena, „hibridna vloga“, ki se nanaša na referenčno zdravilo Eprinex kožni poliv, raztopina za govedo, namenjeno za proizvodnjo mesa in mleka, ki je odobreno v Združenem kraljestvu.
English: 4 OECD guidelines for the testing of chemicals, Test No. 117: Partition Coefficient (n octanol/water), HPLC Method: http://www.oecd-ilibrary.org/environment/test-no-117partition-coefficient-n-octanol-water-hplc-method_9789264069824-en OECD guidelines for the testing of chemicals, Test No.305: Bioaccumulation in Fish: Aqueous and Dietary Exposure: http://www.oecdilibrary.org/content/book/9789264185296-en duration of eprinomectin excretion and the keep off from water bodies two to five weeks after treatment.
Slovenian: 4 OECD guidelines for the testing of chemicals, Test No. 117: Partition Coefficient (n octanol/water), HPLC Method: http://www.oecd-ilibrary.org/environment/test-no-117partition-coefficient-n-octanol-water-hplc-method_9789264069824-en OECD guidelines for the testing of chemicals, Test No.305: Bioaccumulation in Fish: Aqueous and Dietary Exposure: http://www.oecdilibrary.org/content/book/9789264185296-en tudi za živali, prisotne v gnoju.
English: The risk to aquatic ecosystems will be further reduced by keeping treated cattle away from water bodies for two to five weeks after treatment.
Slovenian: Tveganje za vodne ekosisteme in v iztrebkih živeče organizme se dodatno zmanjša, če se zdravljenim živalim v obdobju dva do pet tedne po zdravljenju prepreči neposreden dostop do vodotokov.
English: Summary of product characteristics
Slovenian: Povzetek glavnih značilnosti zdravila
English: Based on the fate data of eprinomectin and the outcome of the PBT assessment it was additionally considered to address the persistency in soil.
Slovenian: Na podlagi podatkov o usodi eprinomektina v okolju in izida ocenjevanja lastnosti PBT so naknadno razmislili tudi o vključitvi informacij o obstojnosti v tleh.
English: Annex II
Slovenian: Dodatek II
English: Amendments in the relevant sections of the Summary of product characteristics and package leaflet
Slovenian: Spremembe zadevnih poglavij Povzetka glavnih značilnosti zdravila in navodil za uporabo
English: Eprinomectin is very toxic to aquatic organisms, is persistent in soils and may accumulate in sediments.
Slovenian: Eprinomektin je zelo toksičen za vodne organizme, obstojen v zemlji in se lahko kopiči v usedlinah.
English: Having considered all the overall submitted data in writing the CVMP concluded that the ERA for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle shows that the product is not expected to pose a risk for the environment when used as recommended in the SPC which includes following the recommended RMM.
Slovenian: Potem ko je proučil vso predloženo pisno dokumentacijo, je odbor CVMP zaključil, da OTO za Norbonex 5 mg/ml kožni poliv, raztopina za govedo, namenjeno za proizvodnjo mesa in mleka, kaže, da ni pričakovati, da bi zdravilo predstavljalo tveganje za okolje, če se bo uporabljalo tako, kot je priporočeno v povzetku glavnih značilnosti zdravila, kar vključuje upoštevanje priporočenih ukrepov za zmanjšanje tveganja.
English: Valid data on the acute and developmental toxicity of eprinomectin to dung beetle larvae were provided which indicated that risk quotient values for dung insects were >1.
Slovenian: Predloženi so bili utemeljeni podatki o akutni in reproduktivni toksičnosti eprinomektina za ličinke hroščev, prisotnih v gnoju, ki kažejo, da so vrednosti količnika tveganja za žuželke, prisotne v gnoju, večje od 1.
English: The deriving bioaccumulation potential and the potential for being considered a PBT compound and secondary poisoning were addressed as required by VICH and CVMP guidelines.
Slovenian: Možnost, da bi se zato snov lahko kopičila v organizmih in da bi jo lahko uvrstili med snovi PBT, ter možnost sekundarne zastrupitve so proučili v skladu z zahtevami smernic VICH in odbora CVMP.
English: Consequently in order to mitigate the risk for dung insects RMM were included in the product information.
Slovenian: Da bi zmanjšali tveganje za žuželke, prisotne v gnoju, so bili zato v informacije o zdravilu vključeni ukrepi za zmanjšanje tveganja.
English: Annex III
Slovenian: Dodatek III
English: Eprinomectin fulfils the 'P' criterion as a conclusion from the PBT assessment and has a high adsorption coefficient (KOC).
Slovenian: Na podlagi ocene lastnosti PBT je bilo zaključeno, da eprinomektin izpolnjuje kriterij „P“ in ima visok absorpcijski koeficient (KOC).
English: On the basis of the ERA no other RMMs were proposed by the applicant.
Slovenian: Na osnovi OTO predlagatelj ni predlagal nobenih drugih ukrepov za zmanjšanje tveganja.
English: Faeces containing eprinomectin excreted onto pasture by treated animals may reduce the abundance of dung feeding organisms which may impact on the dung degradation.
Slovenian: Zaradi eprinomektina v iztrebkih zdravljenih živali se lahko zmanjša število organizmov, ki se prehranjujejo z iztrebki, kar lahko vpliva na razgradnjo iztrebkov.
English: Annex I
Slovenian: Dodatek I
English: Following treatment, excretion of potentially toxic levels of eprinomectin may take place over a period of several weeks.
Slovenian: Izločanje potencialno toksične koncentracije eprinomektina lahko traja še nekaj tednov po zdravljenju.
English: The use of the product poses a risk for aquatic organisms in groundwater and surface water as well as for dung fauna.
Slovenian: Uporaba zdravila predstavlja tveganje za vodne organizme v podzemni in površinski vodi ter
English: Additionally, risk mitigation measures (RMM) have been considered and proposed for the risk identified for dung insects.
Slovenian: Prav tako je obravnaval in predlagal ukrepe za zmanjšanje ugotovljenega tveganja za žuželke, prisotne v gnoju.
English: Therefore, the CVMP recommended the granting of the marketing authorisation for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle with amendment to the summary of product characteristics and package leaflet of the reference Member State.
Slovenian: Odbor CVMP je zato priporočil odobritev dovoljenja za promet z zdravilom Norbonex 5 mg/ml kožni poliv, raztopina za govedo, namenjeno za proizvodnjo mesa in mleka, skupaj s spremembo povzetka glavnih značilnosti zdravila in navodila za uporabo referenčne države članice.
English: Based on available data, the P and T criteria are met and so the remaining B component should be fully assessed.
Slovenian: Razpoložljivi podatki kažejo, da snov izpolnjuje kriterija obstojnosti (P) in strupenosti (T), zato bi bilo treba natančno oceniti preostalo lastnost kopičenja v organizmih (B).
English: These characteristics are also addressed in the SPC and the package leaflet with the information "... is persistent in soils and may accumulate in sediments ".
Slovenian: Te lastnosti so izpostavljene tudi v povzetku glavnih značilnosti zdravila in navodilu za uporabo z navedbo „... je obstojen v zemlji in se lahko kopiči v usedlinah.“ Ta opozorila so ustrezna.
English: Applicant
Slovenian: Vlagatelj
English: Evaluation of the benefit-risk balance
Slovenian: Ocena razmerja med tveganji in koristmi
English: Because eprinomectin is a parasiticide a Phase II assessment according to VICH GL38 was presented
Slovenian: Ker je eprinomektin paraziticid, je bila za zdravilno učinkovino predložena ocena II.
English: Based on the identified risks in the ERA RMM were proposed to address the risk.
Slovenian: Na podlagi tveganj, ugotovljenih v oceni tveganja za okolje, so bili predlagani ukrepi za zmanjšanje teh tveganj.
English: Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle contains eprinomectin, a synthetic avermectin.
Slovenian: Zdravilo Norbonex 5 mg/ml kožni poliv, raztopina za govedo, namenjeno za proizvodnjo mesa in mleka, vsebuje eprinomektin, ki je sintetični avermektin.
English: 3 CVMP Guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC 500004386.pdf for the active ingredient in order to assess the fate of the substance and the effects on organisms that might occur in the environment by the use of the product.
Slovenian: 3 CVMP Guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC 500004386.pdf
English: However, Germany considered no acceptable data in the environmental risk assessment has been provided on bioaccumulation in order to assess the B criterion.
Slovenian: Vendar pa je Nemčija menila, da v okviru ocene tveganja za okolje niso bili predloženi nobeni sprejemljivi podatki o kopičenju v organizmih, ki bi omogočali oceno kriterija B. Posledično je bila zadeva napotena na odbor CVMP v skladu s členom 33(4) Direktive 2001/82/ES.
English: Scientific conclusions and grounds for the granting of the marketing authorisation for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle
Slovenian: Znanstveni zaključki in razlogi za odobritev dovoljenja za promet z zdravilom Norbonex 5 mg/ml kožni poliv, raztopina za govedo, namenjeno za proizvodnjo mesa in mleka
English: Pour-on solution Cattle Topical use
Slovenian: Kožni poliv, raztopina molznice Topikalna uporaba
English: An ERA was provided for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle which was in accordance with VICH and CVMP guidelines.
Slovenian: Za zdravilo Norbonex 5 mg/ml kožni poliv, raztopina za govedo, namenjeno za proizvodnjo mesa in mleka, je bila predložena ocena tveganja za okolje, skladna s smernicami VICH in odbora CVMP.
English: Overall summary of the scientific evaluation of Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Norbonex 5 mg/ml kožni poliv, raztopina za govedo, namenjeno za proizvodnjo mesa in mleka
English: The RMM and warnings in the summary of product characteristics (SPC) and package leaflet address the risk to dung fauna and aquatic organisms by advising on the frequency of re-treatments, the
Slovenian: Ukrepi za zmanjšanje tveganja in opozorila v povzetku glavnih značilnosti zdravila ter navodilu za uporabo bodo tveganje za živali, prisotne v gnoju, in vodne organizme poskušali zmanjšati z informacijami o pogostnosti ponovnega zdravljenja, trajanju izločanja eprinomektina in o tem, da je dva do pet tednov po zdravljenju treba preprečiti približevanje vodnim telesom.
English: The benefit-risk balance is considered positive for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle.
Slovenian: Razmerje med tveganji in koristmi zdravila Norbonex 5 mg/ml kožni poliv, raztopina za govedo, namenjeno za proizvodnjo mesa in mleka, je pozitivno.
English: Grounds for the granting of the marketing authorisation for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle
Slovenian: Podlaga za odobritev dovoljenja za promet z zdravilom Norbonex 5 mg/ml kožni poliv, raztopina za govedo, namenjeno za proizvodnjo mesa in mleka
English: Route of administration
Slovenian: Pot uporabe
English: Strength Pharmaceutical form
Slovenian: Jakost Farmacevtska oblika
English: MA (EU) Number
Slovenian: Številka (EU) dovoljenja za promet
English: Immediate packaging
Slovenian: Velikost pakiranja
English: Contact our press officer Monika Benstetter
Slovenian: Stopite v stik z našo tiskovno predstavnico Monika Benstetter
English: The review looked at data from a large number of studies including:
Slovenian: V pregledu so proučili podatke iz večjega števila študij, med drugim:
English: GFR should be assessed before initiation of treatment and at least annually thereafter.
Slovenian: GFR je treba oceniti pred začetkom zdravljenja, nato pa vsaj enkrat letno.
English: The review of metformin-containing medicines was initiated on 28 January 2016 at the request of the Netherlands, under Article 31 of Directive 2001/83/EC.
Slovenian: Pregled zdravil, ki vsebujejo metformin, se je začel 28. januarja 2016 na zahtevo Nizozemske v skladu s členom 31 Direktive 2001/83/ES.
English: The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's opinion.
Slovenian: Pregled je opravil Odbor za zdravila za uporabo v humani medicini (CHMP), odgovoren za vprašanja glede zdravil za uporabo v humani medicini, ki je sprejel mnenje agencije.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 12/12/2016.
Slovenian: Mnenje odbora CHMP je bilo predloženo Evropski komisiji, ki je 12. decembra 2016 izdala končni pravno zavezujoč sklep, ki velja za vse države članice EU.
English: Tel. +44 (0)20 3660 8427 E-mail: press@ema.europa.eu
Slovenian: Tel. +44 (0)20 3660 8427 E-naslov: press@ema.europa.eu
English: In these cases, stop taking metformin for a short time and speak with your doctor for further instruction.
Slovenian: V tem primeru za kratek čas prenehajte jemati metformin in se posvetujte z zdravnikom, ki vam bo dal nadaljnja navodila.
English: References
Slovenian: Referenčna literatura
English: • If you have any question or concern about your diabetes treatment or your kidney function level, speak with your doctor, nurse or pharmacist.
Slovenian: • Če imate vprašanja ali pomisleke o svojem zdravilu za zdravljenje sladkorne bolezni ali ravni delovanja ledvic, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
English: Information for patients
Slovenian: Informacije za bolnike
English: Medicines containing metformin alone have been authorised nationally in the EU since the 1960s, marketed as Glucophage and other tradenames.
Slovenian: Zdravila, ki vsebujejo samo metformin, so v EU odobrena z nacionalnimi postopki od 60. let 20. stoletja, tržijo pa se pod imenom Glucophage in drugimi trgovskimi imeni.