natgillin/translations-raw huggingface dataset:
What was Tekinex expected to be used for?
Za kaj naj bi se zdravilo Tekinex uporabljalo?
Ph+ means that some of the patient's genes have rearranged themselves to form a special chromosome called the Philadelphia chromosome which produces an enzyme, Bcr-Abl kinase that leads to the development of leukaemia.
Ph+ pomeni, da so se določeni geni bolnika prerazporedili tako, da je nastal poseben kromosom, imenovan kromosom Philadelphia, ki tvori encim, kinazo BCR-ABL, ki povzroči razvoj levkemije.
It was to be used in patients whose previous treatment with imatinib (another anticancer medicine) had failed, possibly due to a mutation in the gene for the Bcr-Abl kinase called the ‘T315I mutation'.
Zdravilo naj bi se uporabljalo pri bolnikih, pri katerih je bilo predhodno zdravljenje z imatinibom (drugim zdravilom proti raku) neuspešno, verjetno zaradi mutacije gena za kinazo BCR-ABL, imenovane „mutacija T315I.“
It is derived from harringtonine, a substance extracted from a Chinese evergreen.
Izdelan je iz haringtonina, snovi, pridobljene iz aglaoneme.
Tekinex was expected to be used to treat adults with ‘Philadelphia chromosome positive' (Ph+) chronic myeloid leukaemia (CML, a cancer of a type of white blood cells called granulocytes).
Zdravilo Tekinex naj bi se uporabljalo za zdravljenje odraslih bolnikov s kronično mieloično levkemijo (KML, rak vrste belih krvnih celic, imenovanih granulociti), „pozitivno na kromosom Philadelphia“ (Ph+).
How is Tekinex expected to work?
Kako naj bi zdravilo Tekinex delovalo?
The T315I mutation changes certain properties of the enzyme, making it harder for these medicines to attach to it. Because omacetaxine does not act in this way, its action is not affected by the T315I mutation.
Ker omacetaksin ne deluje na ta način, mutacija T315I ne vpliva na njegovo delovanje.
Other medicines known as tyrosine kinase inhibitors, including imatinib, act in CML by attaching directly to the Bcr-Abl tyrosine kinase enzyme.
Druga zdravila, ki spadajo v skupino zaviralcev tirozin-kinaze, vključno z imatinibom, pri KML delujejo tako, da se vežejo neposredno na encim tirozin-kinaza BCR-ABL. Mutacija T315I spremeni določene lastnosti encima, kar oteži vezavo teh zdravil nanj.
1 Commission Regulation (EC) NO 1177/2006 of 1 August 2006 implementing Regulation (EC) No 2160/2003 of the European Parliament and of the Council as regards requirements for the use of specific control methods in the framework of the national programmes for the control of Salmonella in poultry (OJ L 212, 2.8.2006, p.3).http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:212:0003:0005:EN:PDF
1 Uredba Komisije (ES) št. 1177/2006 z dne 1. avgusta 2006 o izvajanju Uredbe (ES) št. 2160/2003 Evropskega parlamenta in Sveta glede zahtev za uporabo posebnih metod nadzora v okviru nacionalnih programov za nadzor salmonele pri perutnini (UL L 212, 2.8.2006, str. 3) - http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:212:0003:0005:SL:PDF
Member state/EEA
Država članica/ EGP
Laboratoires Biové 3 rue de Lorraine 62510 Arques FRANCE
Laboratoires Biové 3 rue de Lorraine 62510 Arques FRANCIJA
Carabela La Niña nº 12 5ª planta 08017 Barcelona SPAIN
Carabela La Niña nº 12 5ª planta 08017 Barcelona ŠPANIJA
With regard to established withdrawal periods they ranged in the Member States from 1 to 9 days.
Uveljavljene karence so v državah članicah znašale od 1 do 9 dni.
• the CVMP considered the overall submitted data and the general knowledge on the substance resulting from its well-established used in veterinary medicines for over 20 years.
• CVMP je upošteval vse predložene podatke in splošno vedenje o snovi, ki je bilo zbrano na podlagi dobro uveljavljene uporabe v veterinarski medicini več kot 20 let.
CVMP Note for guidance: Approach towards harmonisation of withdrawal periods http://www.emea.europa.eu/pdfs/vet/swp/003695en.pdf
Navodilo CVMP: pristop k usklajevanju karenc http://www.emea.europa.eu/pdfs/vet/swp/003695en.pdf
It was noted that some parts of the data presented were identical but were submitted by different Applicants/Marketing Authorisation Holders.
Ugotovljeno je bilo tudi, da so bili določeni deli predloženih podatkov enaki, čeprav so jih predložili različni predlagatelji/imetniki dovoljenja za promet z zdravilom.
For some of the products concerned a treatment period of 5 to 7 days was recommended which was considered too long with respect to the aim of achieving an optimal balance between bacteriological cure rate and risk for resistance development.
Za nekaj zadevnih zdravil je bilo priporočeno obdobje zdravljenja 5 do 7 dni, kar se šteje za predolgo glede na cilj doseganja optimalnega ravnovesja med stopnjo bakteriološke ozdravitve in tveganjem pojava odpornosti.
As regards to antimicrobial resistance against colistin it should be noted that firm conclusions regarding antimicrobial resistance could not be reached in the absence of consumption data.
V zvezi s protimikrobno odpornostjo proti kolistinu je treba omeniti, da trdnih zaključkov v zvezi s protimikrobino odpornostjo ni mogoče doseči, če ni podatkov o porabi.
The procedure involved 47 veterinary medicinal products authorised or pending authorisation in different Member States of the European Union (see Annex I).
Postopek je zajel 47 zdravil za uporabo v veterinarski medicini, ki so že odobrena ali v postopku odobritve v državah članicah Evropske unije (glejte Dodatek I).
The duration of treatment currently recommended in the products authorised for calves and lambs was mainly 3 days.
Trajanje zdravljenja, ki je trenutno priporočeno za zdravila, odobrena za teleta in jagnjeta, je v glavnem 3 dni.
The only area of potential risks identified was the risk of lack of efficacy in case of invasive strains and the possibility of interference with Salmonella control programs.
Edino odkrito področje možnega tveganja je bilo tveganje neučinkovitosti v primeru invazivnih sevov ter možnosti interference s programi za nadzor salmonele.
This dose was the recommended dose for the majority of the products included in this referral and has thus been in clinical use for many years.
Ta odmerek je bil priporočen za večino zdravil, ki so vključena v to napotitev, kar pomeni, da so bila v klinični rabi več let.
7100 Vejle
7100 Vejle DANSKA
The data packages submitted consist of bibliographic data, available in the public domain, and proprietary data.
Predloženi sklopi podatkov obsegajo bibliografske podatke, ki so javno dostopni, in pravno zaščitene podatke.
Colistin sulfate is a polypeptide antibiotic belonging to the polymyxins group of antibiotics.
Kolistinijev sulfat je polipeptidni antibiotik iz skupine polimiksinov.
Applicant/ Marketing Authorisation Holder
Predlagatelj/ imetnik dovoljenja za promet z zdravilom
The data submitted to the Committee for evaluation was of poor quality and in some cases lacking to substantiate the claims, doses, duration of treatment or withdrawal periods.
Podatki, predloženi Odboru v oceno, so bili slabe kakovosti in v določenih primerih niso utemeljevali trditev, odmerkov, trajanj zdravljenja in karenc.
CENAVISA, S.A. Camí Pedra Estela S/N
Romunija CENAVISA, S.A. Camí Pedra Estela S/N
Oltenita ROMANIA
Oltenita ROMUNIJA
The submitted data by the Applicants/Marketing Authorisation Holders showed that the concerned veterinary medicinal products are authorised or pending authorisations via different marketing authorisation procedures (mutual recognition procedures or national procedures) and under various legal bases (full and generic).
Podatki, ki so jih predložili predlagatelji/imetniki dovoljenja za promet z zdravilom, so pokazali, da so zadevna zdravila za uporabo v veterinarski medicini odobrena ali v postopku odobritve po različnih postopkih (postopki z medsebojnim priznavanjem ali nacionalni postopki) in na različnih pravnih podlagah (popolnih, generičnih).
Consequently, the use of colistin for the treatment of infections caused by Salmonella may interfere with specific control methods and national programmes for the control of Salmonella;
Posledično lahko uporaba kolistina za zdravljenje okužb, ki jih povzročijo salmonele, ovira specifične metode za nadzor in nacionalne programe za nadzor salmonel;
CEVA SANTE ANIMALE ROMANIA SRL
Romunija CEVA SANTE ANIMALE ROMANIA SRL
There was no documented evidence indicating an increase in the development of resistance relevant to human or animal health.
Ni dokumentiranih dokazov, ki bi kazali povečanja pojavnosti odpornosti, ki bi bila pomembna za zdravje ljudi ali živali.
INN Strength Pharmaceutical form
Jakost Farmacevts ka oblika
Furthermore, the Committee noted that treatment of subclinical Salmonella with the objective to reduce the number of bacteria might interfere with control programmes for this disease1.
Poleg tega je Odbor ugotovil, da zdravljenje subkliničnih okužb s salmonelo s ciljem zmanjšanja števila bakterij morda posega v programe za nadzor te bolezni1.
Two products had a recommended duration of treatment of 3-4 consecutive days.
Dve zdravili imata priporočeno trajanje zdravljenja 3-4 zaporedne dni.
Zone Industrielle des Touches 200, avenue de Mayenne
Romunija Sogeval Zone Industrielle des Touches 200, avenue de Mayenne
The presented clinical data for treatment of salmonelosis in chickens was not conclusive and the appropriateness of using this substance for treating Salmonella infections could be questioned.
Predstavljeni klinični podatki o zdravljenju salmoneloze pri piščancih niso dali jasnih zaključkov, zato je primernost uporabe te snovi za zdravljenje okužb s salmonelo vprašljiva.
Due to the poor absorption in the gut colistin would only be effective against noninvasive Salmonella.
Kolistin bi bil zaradi slabe absorpcije v prebavilih učinkovit le proti neinvazivnim salmonelam.
Ceva Animal Health Slovakia, spol.
Slovaška Ceva Animal Health Slovakia, spol.
The recommended daily dose should be divided into two if the product is to be administered directly into the mouth of the animal.
Priporočeni dnevni odmerek je treba razdeliti v dva dela, če se zdravilo daje neposredno v gobec živali.
With regard to the efficacy in chickens a study report from public literature was provided where E. coli infections were treated with colistin sulfate given in feed.
V zvezi z učinkovitostjo pri piščancih je bilo predloženo poročilo o študiji iz javne literature, v kateri so okužbe z E. coli zdravili s kolistinijevim sulfatom, ki so ga dajali v krmo.
With regard to the duration of treatment of gastrointestinal infections caused by non-invasive E. coli in the target species it was noted that the treatment effect is easily monitored and thus treatment duration can be adjusted according to the course of the disease.
V zvezi s trajanjem zdravljenja okužb prebavil, ki jih povzročajo neinvazivni sevi E. coli pri ciljnih živalskih vrstah, je bilo ugotovljeno, da se učinek zdravljenja enostavno spremlja, zato se lahko trajanje zdravljenja prilagaja glede na potek bolezni.
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, WITHDRAWAL PERIOD AND APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL ZA UPORABO V VETERINARSKI MEDICINI, ŽIVALSKIH VRST, POTI UPORABE, KARENC IN PREDLAGATELJEV/IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
In addition it was noted that the recommended daily dose for calves, lambs and pigs should be divided into two if the product is to be administered directly into the mouth of the animal.
Poleg tega je bilo ugotovljeno, da je treba priporočeni dnevni odmerek za teleta, jagnjeta in prašiče razdeliti v dva dela, če se zdravilo daje neposredno v gobec živali.
This said, it was agreed that the suggested dose of 50 000 IU per kg body weight twice daily was reasonable.
Glede na to je bilo dogovorjeno, da je predlagani odmerek 50 000 i.e. na kg telesne mase dvakrat dnevno razumen.
With regard to the duration of treatment, considering the fact that treatment effect is easily monitored and thus treatment duration can be adjusted according to the course of the disease the Committee agreed to recommend a harmonised duration of treatment of 3-5 days for all products intended for calves and lambs.
Odbor je v zvezi s trajanjem zdravljenja upošteval, da je učinek zdravljenja mogoče enostavno spremljati in se lahko trajanje zdravljenja prilagaja glede na potek bolezni, in se je zato strinjal s priporočilom usklajenega trajanja zdravljenja 3-5 dni za vsa zdravila, ki so namenjena teletom in jagnjetom.
S.C. CRIDA PHARM S.R.L.
Romunija S.C. CRIDA PHARM S.R.L.
It was noted that the analysis, based on the determination of colistin sulfate concentration in the gastrointestinal tract after different levels of exposure and minimum inhibitory concentrations (MIC) data from E. coli strains collected in five European countries could be questioned as the surrogate endpoint Cmax/MIC was not validated for local exposure in the gastrointestinal tract and the fraction of active compound bound to the faecal content was not known.
Ugotovljeno je bilo, da je analiza na podlagi določevanja koncentracij kolistinijevega sulfata v prebavilih po različnih ravneh izpostavitve in podatkov o najnižji inhibicijski koncentraciji (MIK) za seve E. coli, zbranih v petih evropskih državah, vprašljiva, saj nadomestno merilo izida Cmax/MIK ni bilo potrjeno glede lokalne izpostavljenosti v prebavilih, zato delež zdravilne učinkovine, ki je vezana na feces, ni znan.
With regard to the efficacy in pigs the pre-clinical data revealed that the selection of dose rate and dose interval for colistin sulfate in pigs was chosen by using a pharmacokinetic/pharmacodynamic (PK/PD) analysis.
V zvezi z učinkovitostjo pri prašičih so predklinični podatki pokazali, da sta bila hitrost odmerjanja in presledek med odmerki za kolistinijev sulfat pri prašičih izbrana z analizo farmakokinetike/farmakodinamike.
In the submitted Periodic Safety Update Reports no lack of efficacy has been reported for the claimed indications in calves and lambs.
V predloženih rednih posodobljenih poročilih o varnosti zdravil niso poročali o neučinkovitosti za predlagane indikacije pri teletih in jagnjetih.
For some of the products concerned the recommended treatment interval was 3 to 5 days.
Za nekatera zadevna zdravila je bil priporočeno trajanje zdravljenja 3 do 5 dni.
It was noted that no data were submitted by the Applicants/Marketing Authorisation Holders to support the establishment of optimal duration of treatment for colibacilosis in calves and lambs.
Ugotovljeno je bilo, da predlagatelji/imetniki dovoljenja za promet z zdravilom niso predložili podatkov v podporo določitvi optimalnega trajanja zdravljenja kolibaciloze pri teletih in jagnjetih.
However, in view of the well established use of the substance in these species and the fact that there was no new information indicating any new risk associated with the use of colistin in calves and lambs in relation to lack of efficacy or human health the Committee considered that the use of colistin in calves and lambs for the treatment of gastrointestinal infections caused by non-invasive E. coli can be maintained.
Kljub temu z vidika dobro uveljavljene uporabe snovi pri teh živalskih vrstah in dejstva, da ni bilo novih informacij, ki bi kazale nova tveganja, povezana z uporabo kolistina pri teletih in jagnjetih v zvezi z nezadostno učinkovitostjo ali zdravjem ljudi, je Odbor menil, da se lahko uporaba kolistina pri teletih in jagnjetih za zdravljenje okužb prebavil zaradi neinvazivnih sevov E. coli nadaljuje.
With regard to treatment of Salmonella spp.
V okviru tega postopka v podporo indikacije zdravljenja okužb zaradi Salmonella spp.
These studies provide sufficient support for the treatment of colibacilosis in chickens although the correspondence between the in-feed doses used in these studies and the dose recommended for most products within this referral (75 000 IU colistin per kg body weight once daily for 3 days) was not fully justified.
Te študije zadostno podpirajo zdravljenje kolibaciloze pri piščancih, čeprav zveza med odmerki v krmi v teh študijah in priporočenimi odmerki za večino zdravil v napotitvi (75 000 i.e. kolistina na kg telesne mase enkrat dnevno 3 dni) ni popolnoma utemeljena.
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA
5 Chindiei , sector 4 040185 Bucharest ROMANIA
040185 Bucharest ROMUNIJA
• the CVMP considered that the Applicants/Marketing Authorisation Holders did not provide any data or argumentation in support of a claim “…for treatment of gastrointestinal infections caused by Salmonella spp…” in calves, lambs, pigs or poultry.
• CVMP je menil, da predlagatelji/imetniki dovoljenja za promet z zdravilom niso predložili nobenih podatkov ali argumentov v podporo trditvi „…za zdravljenje okužb prebavil zaradi salmonele…“ pri teletih, jagnjetih, prašičih in perutnini.
In the absence of any such data it is considered that this use may constitute a risk to public and animal health as treatment might make the bacteria difficult to detect without completely eliminating the infection/colonisation and therefore result in persistence of zoonotic organisms in treated animals and in the environment and delays in effective elimination.
Zaradi odsotnosti kakršnih koli takšnih podatkov se šteje, da taka raba lahko pomeni tveganje za javno zdravje in zdravje živali, saj zdravljenje morda oteži odkrivanje bakterije, hkrati pa okužbe/kolonizacije ne odpravi popolnoma, zato povzroči obstojnost zoonotskih organizmov v zdravljenih živalih in v okolju ter odloži učinkovito odstranitev.
The extensive MIC data presented by the Applicants/Marketing Authorisation Holders covering the period during which colistin sulfate has been in clinical use indicates quite clearly that resistance development was not an issue of concern for this substance.
Predlagatelji/imetniki dovoljenja za promet z zdravilom so predložili obsežne podatke o MIK, ki zajemajo obdobje klinične uporabe kolistinijevega sulfata in jasno kažejo, da pri tej učinkovini pojav odpornosti ni zadržek.
This group of antibiotics has a polypeptide structure, with mainly bactericide activity and a medium antibacterial spectrum, which covers gram-negative microorganisms only.
Njihov protibakterijski spekter je srednje širok in zajema le gramnegativne mikroorganizme.
For 3 consecutive days.
TM/dan 3 zaporedne dni
4.9 Amounts to be administered and administration route To be administered orally.
4.9 Odmerjanje in pot uporabe Zdravilo se daje peroralno.
Considering the general knowledge that the substance is poorly absorbed from the gastro-intestinal tract the Committee considered that the withdrawal period of 1 day as recommended for calves, pigs and chicken can also be supported for lambs and poultry species other than chickens.
Odbor je ob upoštevanju splošnega znanja, da se snov slabo absorbira iz prebavil, menil, da se lahko karenca 1 dan, ki je priporočena za teleta, prašiče in piščance, podpre tudi za jagnjeta in za drugo perutnino kot piščance.
Furthermore there is no new information indicating any new risk associated with the use of colistin in calves and lambs in relation to lack of efficacy or emerging resistance relevant to public or animal health.
Poleg tega ni novih informacij, ki bi kazale na nova tveganja v povezavi z rabo kolistina pri teletih in jagnjetih zaradi zmanjšane učinkovitosti ali porajanja odpornosti, ki bi bila pomembna za javno zdravje in zdravje živali.
Complete or partial lack of efficacy can result in persistence of zoonotic organisms in treated animals (and in the environment) and delay effective elimination of Salmonella due to treatment failure.
Popolna ali delna neučinkovitost lahko povzroči obstojnost zoonotskih organizmov v zdravljenih živalih (in v okolju) ter odloži učinkovito odstranitev salmonele zaradi neuspešnega zdravljenja.
The United Kingdom expressed concerns that differences in the posology and withdrawal periods established across the European Union for veterinary medicinal formulations containing colistin at 2 000 000 IU/ml and intended for administration in drinking water to any food producing species may present a potential serious risk to public and animal health.
Združeno kraljestvo je izrazilo zadržke, da razlike v odmerjanju in karencah, ki so v veljavi v Evropski uniji za formulacije zdravil za uporabo v veterinarski medicini, ki vsebujejo 2 000 000 i.e. kolistina/ml in so namenjene dajanju s pitno vodo živalskim vrstam za prehrano ljudi, lahko pomenijo možno resno tveganje za javno zdravje in zdravje živali.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION To be administered orally.
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE ZDRAVILA Zdravilo se daje peroralno.
Concentrate for Oral Solution for use in drinking water for Cattle, Sheep, Swine and Chickens
Concentrate for Oral Solution for use in drinking water for Cattle, Sheep, Swine and Chickens kolistin (v obliki sulfata)
With regard to gastrointestinal infections caused by non-invasive E. coli in calves and lambs the data submitted to support the indication were limited.
V zvezi z okužbami prebavil z neinvazivnimi sevi E. coli pri teletih in jagnjetih je podatkov, ki so bili predloženi v podporo indikaciji, malo.
The dose currently recommended in all products authorised for calves and lambs is a harmonised dose of 100 000 IU colistin per kg body weight daily.
Trenutno priporočeni odmerek vseh zdravil, odobrenih za teleta in jagnjeta, je usklajeni odmerek 100 000 i.e. kolistina na kg telesne mase dnevno.
49500 Segré Cedex FRANCE
49500 Segré Cedex FRANCIJA
• the CVMP considered that colistin administered orally has been used to treat gastrointestinal infections caused by non-invasive E. coli infections in calves, lambs, pigs and poultry during decades.
• CVMP je menil, da se je kolistin že več desetletij uporabljal peroralno za zdravljenje okužb prebavil, ki jih povzročajo neinvazivni sevi E. coli pri teletih, jagnjetih, prašičih in perutnini.
In view of the residue data submitted in support of the withdrawal periods in calves, pigs and chickens, and general knowledge that the substance is poorly absorbed from the gastrointestinal tract, the Committee considered that the same withdrawal period of 1 day could be recommended for these animal species.
Odbor je z vidika predloženih podatkov o ostankih pri teletih, prašičih in piščancih ter splošnega vedenja, da se snov slabo absorbira iz prebavil, menil, da se lahko enaka karenca 1 dan priporoči tudi za omenjene živalske vrste.
In the submitted Periodic Safety Update Reports neither lack of efficacy nor emerging resistance development has been reported for the approved indications in any of the approved target species;
V predloženih rednih posodobljenih poročilih o varnosti zdravil za predlagane indikacije pri nobeni odobreni ciljni živalski vrsti niso poročali o neučinkovitost ali o porajajočem se pojavu odpornosti;
the CVMP has recommended the variation of the Marketing Authorisations and amendments of the relevant sections of the Summary of Product Characteristics, labelling and package leaflet and where applicable as set out in Annex III of the Opinion for the veterinary medicinal formulations containing colistin at 2 000 000 IU/ml and intended for administration in drinking water to any food producing species as referred in Annex I of the Opinion.
je CVMP priporočil spremembo dovoljenj za promet z zdravilom in dopolnitev zadevnih poglavij povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo ter kadar je to ustrezno, kakor je določeno v Dodatku III mnenja za formulacije zdravil za uporabo v veterinarski medicini, ki vsebujejo 2 000 000 i.e. kolistina/ml in so namenjena dajanju v pitno vodo živalskim vrstam za proizvodnjo živil, kakor je opisano v Dodatku I mnenja.
Colivet 2 000 000 UI /ml, concentrate for oral solution for pigs and birds
Colivet 2 000 000 UI /ml, concentrate for oral solution for pigs and birds koncentrat za peroralno raztopino prašiči domače ptice