FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore the main point for discussion was whether the free fraction immediately after infusion of Taxotere and Docetaxel Teva Generics is the same, and whether the docetaxel is released at a sufficiently equal rate from the Taxotere micelles and the Docetaxel Teva Generics HP-b-CD.
Slovenian: Tako je razprava potekala predvsem v zvezi s vprašanjem, ali je prosta frakcija takoj po infuziji zdravila Taxotere in zdravila Docetaxel Teva Genercis enaka in ali se docetaksel iz micel zdravila Taxotere in iz HP-b-CD zdravila Docetaxel Teva Generics sprošča s približno enako hitrostjo.
English: • With regard to safety related to the excipients, it was considered that the different excipients povidone K-12 and HP-b-CD are used in other medicinal products for intravenous use, and thus have been previously applied in humans.
Slovenian: • Glede varnosti v zvezi s pomožnimi snovmi se je upoštevalo, da se pomožni snovi povidon K-12 in HP-b-CD uporabljata tudi pri drugih zdravilih za intravensko uporabo in sta tako že bili uporabljeni pri ljudeh.
English: It is assumed that if sufficient reassurance is provided that systemic exposure to the active ingredient between the innovator Taxotere and Docetaxel Teva Generics is the same, then safety and efficacy related to docetaxel will be the same as well.
Slovenian: Domneva se, da bosta ob predložitvi ustrezne potrditve, da je sistemska izpostavljenost zdravilni učinkovini pri inovatorskem zdravilu Taxotere in zdravilu Docetaxel Teva Generics enaka, enaki tudi varnost in učinkovitost v zvezi z docetakselom.
English: However according to the objecting concerned member state (CMS), the in vitro data provided were insufficient to demonstrate similar in vivo behaviour.
Slovenian: Vendar je ugovarjajoča zadevna država članica menila, da predloženi podatki in vitro niso zadostno dokazali podobnega delovanja in vivo.
English: This assumption is also supported by animal data.
Slovenian: To domnevo podpirajo tudi podatki pri živalih.
English: The aim of the assessment has been to clarify if systemic exposure to docetaxel from Taxotere and Docetaxel Teva Generics is equal.
Slovenian: Cilj ocenjevanja je bil ugotoviti, ali je sistemska izpostavljenost docetakselu iz zdravila Taxotere in zdravila Docetaxel Teva Generics enaka.
English: Following infusion, the active ingredient and excipients are highly diluted in the patient's plasma.
Slovenian: Po infundiranju so zdravilna učinkovina in pomožne snovi v bolnikovi plazmi zelo razredčene.
English: In vitro protein binding data submitted during the initial procedure, CMD(h) referral procedure and the current CHMP referral procedure indicated that the dissociation pattern and protein binding is similar for docetaxel from Docetaxel Teva Generics and Taxotere at clinically relevant concentrations.
Slovenian: Podatki o vezavi in vitro na beljakovine, ki so bili predloženi v prvotnem postopku, med napotitvenim postopkom Usklajevalne skupine za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMD( h)) in trenutno potekajočim napotitvenim postopkom v CHMP so pokazali, da je vzorec disociacije in vezave na beljakovine pri docetakselu iz zdravila Docetaxel Teva Generics in zdravila Taxotere pri klinično pomembnih koncentracijah podoben.
English: The micelle forming polysorbate used in the originator is exchanged for a cyclodextrin derivative in Docetaxel Teva Generics, which has a different form of interaction with the drug substance.
Slovenian: Polisorbat, ki tvori micele, in se uporablja v originatorju, je v zdravilu Docetaxel Teva Generics zamenjan z derivatom ciklodekstrina, ki z zdravilno učinkovino medsebojno deluje na drugačen način.
English: With regard to safety related to the excipients, it was considered by the RMS that the different excipients povidone K12 and HP-b-CD are being used in other medicinal products for intravenous use, and thus have been applied in humans.
Slovenian: Glede varnosti v zvezi s pomožnimi snovmi je referenčna država članica menila, da se pomožni snovi povidon K12 in HP-b-CD uporabljata tudi pri drugih zdravilih za intravensko uporabo ter sta tako že bili uporabljeni pri ljudeh.
English: The objecting CMSs argued that the formulation of Docetaxel Teva Generics is not equivalent to the originator as a different excipient is used.
Slovenian: Ugovarjajoče zadevne države članice so trdile, da formulacija zdravila Docetaxel Teva Generics ni enakovredna originatorju, saj je uporabljena drugačna pomožna snov.
English: The formulation of Docetaxel Teva Generics is not the same as the reference product as a different excipient is used.
Slovenian: Formulacija zdravila Docetaxel Teva Generics ni enaka formulaciji referenčnega zdravila, saj je uporabljena drugačna pomožna snov.
English: This assumption is supported by the provided animal data.
Slovenian: To domnevo podpirajo tudi predloženi podatki pri živalih.
English: The RMS was therefore of the view that the in vitro data provided, supported by the animal PK and PD data, are sufficient to demonstrate a comparable in vivo behaviour.
Slovenian: Referenčna država članica je tako menila, da predloženi podatki in vitro, ki so jih potrdili tudi farmakokinetični/farmakodinamični podatki pri živalih, ustrezno dokazujejo primerljivo delovanje in vivo.
English: • The in vitro protein binding data point at comparable docetaxel exposure obtained from Taxotere and Docetaxel Teva Generics;
Slovenian: • Podatki in vitro o vezavi beljakovin kažejo na primerljivo izpostavljenost docetakselu pri zdravilu Taxotere in zdravilu Docetaxel Teva Generics.
English: All data considered collectively were thought to strongly suggest comparable docetaxel exposure obtained from Taxotere and Docetaxel Teva Generics.
Slovenian: Skupno obravnavanje vseh podatkov naj bi jasno kazalo na primerljivost izpostavljenosti docetakselu pri zdravilu Taxotere in zdravilu Docetaxel Teva Generics.
English: To conclude, an approval could not be recommended unless the applicant could demonstrate comparable PK-profiles in vivo in man. Until now, no study in man has been conducted with this new formulation.
Slovenian: Tako odobritve ni mogoče priporočiti, dokler predlagatelj ne dokaže primerljivih farmakokinetičnih profilov in vivo pri ljudeh.
English: This should therefore be acceptable.
Slovenian: Zato je to sprejemljivo.
English: The responses were submitted to the EMEA on 19 December 2006.
Slovenian: Odgovori so bili predloženi agenciji EMEA 19. decembra 2006.
English: Belgium, Czech Republic, Germany, Greece, Spain, France, Italy, The Netherlands, Poland, Portugal and Slovakia
Slovenian: Belgija, Češka republika, Nemčija, Grčija, Španija, Francija, Italija, Nizozemska, Poljska, Portugalska in Slovaška
English: This is in agreement with the German Competent National Authority (BVL) and expert opinion.
Slovenian: To je skladno z mnenjem nemškega pristojnega nacionalnega organa (BVL) in strokovnim mnenjem.
English: In addition, a negative control was used.
Slovenian: Poleg tega je uporabil tudi negativno kontrolo.
English: Resistance was covered adequately in literature.
Slovenian: Odpornost je v literaturi zadostno obravnavana.
English: For these reasons, the appropriate proposed indication is suggested as follows:
Slovenian: Zaradi tega se kot ustrezna indikacija predlaga naslednja:
English: Adverse reactions (frequency and seriousness)
Slovenian: Neželeni učinki (pogostnost in resnost)
English: The Committee agreed that all prudent use recommendations should be put under 4.5.
Slovenian: Odbor se je strinjal, da se vsa priporočila za preudarno rabo navedejo v poglavju 4.5.
English: After oral administration, in most species values higher than 70% are reached.
Slovenian: Po peroralni uporabi se pri večini vrst dosežejo vrednosti, večje od 70 %.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram contains:
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsak gram vsebuje:
English: (2) Five expert opinions written by veterinarians who work closely with large pigs farms in Spain, all containing positive comments on their use of this product.
Slovenian: (2) Pet strokovnih mnenj veterinarjev, ki tesno sodelujejo z velikimi prašičjimi farmami v Španiji, pri čemer vsa vsebujejo pozitivne komentarje o uporabi zdravila.
English: Similar products with 8 or 10 days treatment durations are also available within the EU.
Slovenian: V EU so na voljo tudi podobna zdravila s trajanjem zdravljenja 8 ali 10 dni.
English: Global evaluations were justified because the statistical guideline incorporates them.
Slovenian: Globalna vrednotenja so upravičena, saj jih vključuje statistično priporočilo.
English: Avoid skin and eye contact.
Slovenian: Izogibajte se stiku s kožo in očmi.
English: Do not smoke, eat or drink while handling the product.
Slovenian: Med uporabo izdelka ne kadite, jejte ali pijte.
English: Fax: +34 933 727 556 e-mail: invesa@invesagroup.com
Slovenian: Faks: +34 933 727 556 e-pošta: invesa@invesagroup.com
English: After first opening, keep the pack tightly closed.
Slovenian: Po prvemu odpiranju hranite ovojnino tesno zaprto.
English: At least two mechanisms of resistance to tetracyclines exist.
Slovenian: Obstajata vsaj dva mehanizma odpornosti na tetracikline.
English: Germany notified the EMEA on 30 May 2006 that the CMD(v) failed to reach an agreement regarding the product.
Slovenian: Nemčija je 30. maja 2006 obvestila agencijo EMEA, da v usklajevalni skupini CMD(v) ni bilo doseženo soglasje o zdravilu.
English: Do not use after the expiry date.
Slovenian: Ne uporabljajte po izteku roka uporabnosti.
English: Tetracyclines, ATCvet code: QJ01AA02.
Slovenian: Tetraciklini, oznaka ATC vet: QJ01AA02.
English: Binding to plasmatic proteins is about 90-92%.
Slovenian: Vezava na plazemske beljakovine je približno 90-92 %.
English: During the Mutual Recognition Procedure this statistical evaluation was questioned and found to be inappropriate.
Slovenian: V postopku medsebojnega priznavanja so v statistično vrednotenje dvomili in ugotovili njegovo neustreznost.
English: Farms were selected if at least 20% of pigs were showing clinical signs of respiratory disease.
Slovenian: Kmetije so bile izbrane, če je najmanj 20 % prašičev kazalo klinične znake bolezni dihal.
English: The most important mechanism is due to the decrease of the cellular accumulation of the drug.
Slovenian: Najpomembnejši mehanizem je posledica zmanjšanja celične akumulacije zdravila.
English: This is also the indication applied for at the start of the mutual recognition procedure (MRP).
Slovenian: Ta indikacija je navedena tudi v vlogi za začetek postopka medsebojnega priznavanja (MRP).
English: Annex I of Directive 2001/82/EC as amended by directive 2004/28/EC notes that post-marketing experience with other products containing the same constituents is of particular importance and applicants should put a special emphasis on this issue.
Slovenian: Priloga I k Direktivi 2001/82/ES, kakor je bila spremenjena z Direktivo 2004/28/ES, določa, da so zelo pomembne izkušnje, pridobljene po uvedbi drugih zdravil v promet, ki vsebujejo enake sestavine, in da se morajo vlagatelji tej problematiki posebej posvetiti.
English: The reason for this was that the national competent authority of Germany considered that this veterinary medicinal product could present a potential serious risk to animal health on the grounds that the efficacy has not been sufficiently substantiated in the dossier.
Slovenian: Razlog za to je bilo mnenje nacionalnega pristojnega organa Nemčije, da lahko to zdravilo za uporabo v veterinarski medicini predstavlja potencialno resno tveganje za zdravje živali, saj v dosjeju učinkovitost zdravila ni bila zadostno utemeljena.
English: However, the study was conducted and assessed prior to these requirements and the applicant has attempted many additional analyses on the original data and has justified various deficiencies.
Slovenian: Vendar je bila raziskava opravljena in ovrednotena pred uvedbo teh zahtev, zato je vlagatelj poskusil opraviti številne dodatne analize prvotnih podatkov ter utemeljil različne pomanjkljivosti.
English: Pharmacotherapeutic group: Antibacterials for systemic use.
Slovenian: Farmakoterapevtska skupina: Antibakterijska sredstva za sistemsko uporabo.
English: DOXYPREX Premix
Slovenian: DOXYPREX premiks
English: Before granulation, flour should not reach a temperature higher than 55 ºC.
Slovenian: Pred granuliranjem moka ne sme preseči temperature 55 °C.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Slovenian: BESEDILO »SAMO ZA ŽIVALI« IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je navedba smiselna
English: If it occurs, it is recommended to wash the area with plenty of water.
Slovenian: Če pride do njega, je priporočeno, da mesto sperete z obilico vode.
English: Pulmodox is indicated for prevention of clinical respiratory disease and not for treatment,
Slovenian: Zdravilo Pulmodox je indicirano za preprečevanje klinične bolezni dihal in ne za zdravljenje.
English: Conclusion and recommendation
Slovenian: Sklep in priporočilo
English: Once absorbed, the drug is bound in a very high percentage (93%) to plasmatic proteins.
Slovenian: Po absorpciji se zdravilo v zelo velikem odstotku (93 %) veže na plazemske beljakovine.
English: The presence was assumed.
Slovenian: Prisotnost tega organizma so domnevali.
English: Concentrations that reaches in lung are always higher than in plasma.
Slovenian: Koncentracije, ki dosežejo pljuča, so vedno večje kot v plazmi.
English: The applicant has explained the choice of dose.
Slovenian: Vlagatelj je pojasnil izbiro odmerka.
English: Therefore, the recommendation is to remove this pathogen from the indications.
Slovenian: Zato CVMP priporoča umaknitev tega patogenega organizma iz indikacij.
English: The CVMP/627/01 and GCP guideline stated that the response to therapy must be based on clinical and microbiological criteria wherever possible.
Slovenian: Dokument CVMP/627/01 in smernice za dobro klinično prakso (GCP) določajo, da je treba odziv na zdravljenje opredeliti s kliničnimi in mikrobiološkimi kriteriji, kjer je možno.
English: The submitted post marketing experience consists of:
Slovenian: Predloženi postmarketinški podatki so obsegali:
English: Food can slightly modify oral bioavailability of doxycycline.
Slovenian: Hrana lahko nekoliko spremeni peroralno biološko razpoložljivost doksiciklina.
English: If you notice any serious effects or other effects not mentioned in this label, please inform your veterinary surgeon.
Slovenian: Če opazite kakršne koli resne stranske učinke ali druge učinke, ki niso navedeni v teh navodilih za uporabo, obvestite svojega veterinarja.
English: It reaches well irrigated and peripheral tissues.
Slovenian: Doseže dobro prepojena in periferna tkiva.
English: The applicant felt that this was more adapted towards the Guideline EMEA/CVMP/816/00 and obtained greater clinical significance.
Slovenian: Vlagatelj meni, da je to statistično vrednotenje bolj prilagojeno smernici EMEA/CVMP/816/00 in da zagotavlja večji klinični pomen.
English: Alteration in the transport system is produced by inducible proteins codified in plasmids and transposons.
Slovenian: Spremembo transportnega sistema povzročijo inducibilne beljakovine, kodirane v plazmidih in transpozonih.
English: DATE OF REVISION OF THE TEXT {<DD/MM/YYYY>}
Slovenian: DATUM REVIZIJE BESEDILA {<DD/MM/LLLL>}
English: 100 mg/g Pigs (after weaning)
Slovenian: 100 mg/g prašiči (po odstavitvi)
English: The clinical end points were ”Time to clinical cure” and ”overall clinical cure”.
Slovenian: Klinični končni točki sta bili „čas do klinične ozdravitve“ in „celokupna klinična ozdravitev“.
English: (1) Pharmacovigilance - reporting a nil return for suspected adverse drugs reactions and lack of efficacy; and
Slovenian: (1) Farmakovigilanco - poročilo o neobstoju vračil zdravila zaradi suma neželenih reakcij, povezanih z zdravilom, ali pomanjkljive učinkovitosti; in
English: Therefore, the CVMP considered that the reports mentioned above give favourable evidence for the safety and efficacy of doxycycline in general, but also for the specific final formulation as marketed in Spain.
Slovenian: Zato je CVMP ugotovil, da so zgoraj omenjena poročila ustrezen dokaz varnosti in učinkovitosti doksiciklina na splošno in tudi za specifično končno formulacijo, ki je v prometu v Španiji.
English: Store below 30 ºC.
Slovenian: Shranjujte pri temperaturi do 30 ºC.
English: Inflammation of the face, lips and eyes or respiratory difficulty are more severe signs that require urgent medical attention.
Slovenian: Vnetje obraza, ustnic in oči ali težave pri dihanju so hujši znaki, ki zahtevajo nujno zdravniško oskrbo.
English: Therefore the applicant performed another statistical evaluation using the original database.
Slovenian: Zato je vlagatelj opravil drugo statistično vrednotenje prvotne zbirke podatkov.
English: It is recommended to use a non-powder mask (according to the EN140FFP1 regulation), gloves, working suit and approved safety glasses.
Slovenian: Priporočeno je, da uporabljate masko brez smukca (skladno s predpisom EN140FFP1), rokavice, delovno obleko in odobrena zaščitna očala.
English: If symptoms appear after exposition as a skin eruption, a doctor should be consulted showing these warnings.
Slovenian: Če se po izpostavljenosti pojavijo simptomi, kot je kožni izbruh, se posvetujte z zdravnikom in mu pokažite ta opozorila.
English: To sum up the applicant has indeed performed a number of analyses based on the original data and they seem to have been performed appropriately.
Slovenian: Če povzamemo: vlagatelj je dejansko opravil številne analize prvotnih podatkov in zdi se, da bila izvedba analiz ustrezno opravljena.
English: Time to clinical cure was considered the primary end point.
Slovenian: Čas do klinične ozdravitve je veljal za primarno končno točko.
English: The feed consumption will depend on the clinical condition of the animal.
Slovenian: Poraba krmne mešanice je odvisna od kliničnega stanja živali.
English: The applicant has submitted a scientific report on Porcine Respiratory Disease Complex (PRDC) and also pointed out that the above mentioned Guideline were not in effect at time of the study or the initial submission to the Spanish Authority.
Slovenian: Vlagatelj je predložil znanstveno poročilo o kompleksu prašičjih bolezni dihal (PRDC) in poudaril, da omenjene smernice še niso veljale niti v času raziskave niti ob prvi vlogi za odobritev pri španskem pristojnem organu.
English: Its hepatic metabolism is scarce, showing traces of some metabolites at kidney level.
Slovenian: Njegov jetrni metabolizem je majhen in kaže sledi nekaterih presnovkov na ledvični ravni.
English: In addition the pharmacokinetics study using their final formulation and more up-to-date (2001) MIC data for respiratory pathogens isolated from pigs in Spain are provided.
Slovenian: Poleg tega je bila predložena študija farmakokinetike, v kateri je bila uporabljena končna formulacija, in sodobnejši (2001) podatki o MIK za respiratorne patogene mikroorganizme, osamljene iz prašičev v Španiji.
English: Given that the statistical analysis is appropriate, this study design can conclude that the actual final formulation has shown field efficacy when compared to a negative control group and has produced as least as good results as a comparator product TM550 (oxytetracycline).
Slovenian: Ker je statistična analiza ustrezna, lahko na podlagi načrta te raziskave zaključimo, da je bila za dejansko končno formulacijo dokazana učinkovitost na terenu v primerjavi z negativno kontrolno skupino ter da so rezultati te formulacije najmanj enako dobri kot rezultati primerjalnega zdravila TM550 (oksitetraciklin).
English: Efficacy against M. hyopneumoniae has furthermore not been established in the field study, since its presence was not demonstrated.
Slovenian: Poleg tega učinkovitosti proti M. hyopneumoniae v terenski raziskavi niso dokazali, saj prisotnosti tega organizma niso določali.
English: These are all references provided with the original submission.
Slovenian: Vse to je zajeto v referencah, ki so bile priložene prvotni vlogi za dovoljenje.
English: It is concentrated in liver, kidney, bones and intestine; in this last case it is due to an enterohepatic cycle.
Slovenian: Koncentriran je v jetrih, ledvicah, kosteh in črevesu; v slednjem je koncentriran zaradi enterohepatičnega obtoka.
English: Oral bioavailability of doxycycline ranges between 50-60% values.
Slovenian: Peroralna razpoložljivost doksiciklina je med 50-60 % vrednosti.
English: It is recommended that one part of Doxyprex is first mixed into one part of the feeding stuff, followed by the rest of the feeding stuff and mixed well.
Slovenian: Priporočeno je, da se najprej en del zdravila Doxyprex vmeša v en del krmne mešanice, potem se doda preostala krmna mešanica in dobro premeša.
English: It is due to the establishment of an elimination route by pumping the antibacterial agent or to an alteration in the transport system, resulting in a limited tetracycline energy-dependent capture to the exterior of the cell.
Slovenian: To se zgodi zaradi vzpostavitve eliminacijske poti s črpanjem antibakterijskega sredstva ali zaradi spremembe transportnega sistema, kar povzroči omejeno dostopnost tetraciklina, odvisno od energije, za zunanji del celice.
English: The applicant explained that their choice of positive controls in the pivotal field trial was not intended to compare their product with a product, which had been used for the same proposed posology within the Community for at least 10 years.
Slovenian: Vlagatelj je pojasnil, da namen njegove izbire pozitivnih kontrol v ključnem preskušanju na terenu ni bil primerjava lastnega zdravila z zdravilom, ki se je v Skupnosti uporabljalo za enako predlagano odmerjanje najmanj 10 let.
English: The other mechanism is evidenced by a reduction in the affinity of the ribosome for the Tetracycline-Mg2+ complex due to mutations in the chromosome.
Slovenian: Drug mehanizem se kaže z zmanjšanjem afinitete ribosoma za kompleks tetraciklin-Mg2+, ki ga povzročijo mutacije v kromosomu.
English: There are however differences in both dose recommendation (12.5 mg/kg/day versus 10 mg/kg/day) and duration of treatment (8 versus 7 days).
Slovenian: Obstajajo pa razlike v priporočenem odmerjanju (12,5 mg/kg/dan v primerjavi z 10 mg/kg/dan) in trajanju zdravljenja (8 dni v primerjavi s 7 dnevi).
English: Meat and offal: 7 days.
Slovenian: Meso in drobovje: 7 dni.
English: Pelleting conditions involve preconditioning ingredients with steam at 55-65ºC and 10% moisture.
Slovenian: Pogoji za peletiranje vključujejo vnaprej določene sestavine s paro pri 55-65 °C in 10-odstotno vlago.
English: A new primary end point was defined as Time to clinical cure, i.e. the time to absence of clinical signs.
Slovenian: Opredeljena je bila nova primarna končna točka: čas do klinične ozdravitve, tj. čas do izginotja kliničnih znakov.
English: Although on the surface the individual numbers of pigs involved looks small, the applicant has justified that because of the large difference in results between the Doxyprex and control groups the small number of animals still allows a 80% power to be achieved.
Slovenian: Čeprav morda število vključenih prašičev zgleda majhno, vlagatelj trdi, da velika razlika med rezultati za zdravilo Doxyprex in rezultati iz kontrolnih skupin še vedno omogoča 80-odstotno moč raziskave pri majhnem številu živali.
English: Store in a dry place.
Slovenian: Shranite na suhem mestu.
English: In fact the two positive controls were selected because at that time there were no doxycycline based premix reference products available in Spain.
Slovenian: Pozitivni kontroli sta bili izbrani, ker takrat referenčnih premiksov na osnovi doksiciklina v Španiji ni bilo na voljo.
English: Absorption after oral and intramuscular administration shows a high bioavailability.
Slovenian: Absorpcija po peroralni in intramuskularni uporabi kaže na dobro biološko razpoložljivost.