natgillin/translations-raw huggingface dataset:
As a consequence, Lunivia would not have been able to benefit from 10 years of ‘market exclusivity'.
Zato zdravilo Lunivia ne bi moglo biti upravičeno do desetletne „tržne ekskluzivnosti“.
Although it is chemically different from the benzodiazepines, eszopiclone acts on the same receptors in the brain.
Čeprav se eszopiklon kemijsko razlikuje od benzodiazepinov, učinkuje na iste receptorje v možganih.
Lunivia was expected to be used to treat adults with insomnia, including difficulty falling asleep, waking up during the night and waking up early, usually for short periods.
Zdravilo Lunivia naj bi se uporabljalo za zdravljenje odraslih, ki imajo težave z nespečnostjo, vključno s tem, da težko zaspijo, se zbujajo ponoči oziroma se zbujajo zgodaj, ponavadi za krajša obdobja.
It is a purified form of one of the two ‘enantiomers' (mirror-image forms) of the substance zopiclone.
Je prečiščena oblika enega od obeh „enantiomerov“ (zrcalnih oblik) snovi zopiklon.
This is the period during which other companies would have been prevented from marketing ‘generic medicines' of Lunivia (medicines that contain the same active substance at the same dose as Lunivia and that are used for the same conditions).
To je obdobje, v katerem druge družbe ne smejo tržiti „generikov“ zdravila Lunivia (zdravil, ki vsebujejo isto zdravilno učinkovino v enakem odmerku kot zdravilo Lunivia in se uporabljajo za iste bolezni).
The company had requested a re-examination of the CHMP's opinion, but after re-examining the opinion, the Committee had confirmed its earlier opinion.
Družba je zahtevala ponovno presojo mnenja CHMP, vendar je Odbor po ponovni presoji mnenja potrdil svoje prvotno mnenje.
However, the Committee had also concluded that eszopiclone could not be considered to be a new active substance.
Odbor pa je tudi pripomnil, da eszopiklon ne more veljati kot nova zdravilna učinkovina.
The CHMP had no major concerns and the application could have been approved.
CHMP ni imel nobenih večjih zadržkov in je menil, da se vloga lahko odobri.
Based on the review of the data and the company's response to the CHMP's lists of questions, at the time of the withdrawal, the CHMP had given a positive opinion, recommending that a marketing authorisation be granted for Lunivia for the treatment of insomnia.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je zastavil CHMP, je Odbor v času umika vloge izrazil pozitivno mnenje in priporočil odobritev dovoljenja za promet z zdravilom Lunivia, namenjenim zdravljenju nespečnosti.
Questions and answers on the withdrawal of the marketing authorisation application for Lunivia eszopiclone
Vprašanja in odgovori v zvezi z umikom vloge za dovoljenje za promet z zdravilom Lunivia eszopiklon
On 13 May 2009, Sepracor Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Lunivia, for the treatment of insomnia.
Družba Sepracor Ltd. je dne 13. maja 2009 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Lunivia, namenjenim zdravljenju nespečnosti.
What documentation did the company present to support its application to the CHMP?
Katero dokumentacijo je družba predložila odboru CHMP v podporo svoji vlogi?
It activates receptors in the brain called gamma-aminobutyric acid A (GABA-A) receptors, which are involved in bringing about sleep.
Aktivira receptorje v možganih, imenovane gama-aminomaslena kislina A (GABA-A), ki sodelujejo pri tem, da človek zaspi.
By activating these receptors, eszopiclone can help patients with insomnia to sleep.
Eszopiklon z aktiviranjem teh receptorjev pomaga bolnikom, ki trpijo za nespečnostjo, da zaspijo.
What are the consequences of the withdrawal for patients in clinical trials using Lunivia?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih zdravila Lunivia?
The active substance in Lunivia, eszopiclone, belongs to a group of medicines that are related to the benzodiazepines.
Zdravilna učinkovina v zdravilu Lunivia, eszopiklon, spada v skupino zdravil, ki so sorodna benzodiazepinom.
All of the studies compared Lunivia with placebo (a dummy treatment).
V vseh študijah so zdravilo Lunivia primerjali s placebom (zdravilom brez zdravilne učinkovine).
Lunivia is a medicine that contains the active substance eszopiclone.
Lunivia je zdravilo, ki vsebuje zdravilno učinkovino eszopiklon.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Lunivia.
Družba je CHMP obvestila, da umik vloge za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Lunivia, nima posledic.
What was Lunivia expected to be used for?
Za kaj naj bi se zdravilo Lunivia uporabljalo?
What is Lunivia?
Kaj je zdravilo Lunivia?
How does Lunivia work?
Kako zdravilo Lunivia deluje?
Duration of effect
Trajanje učinka
Indirect or additional benefits
Neposredne ali dodatne koristi
Florgane 300 mg/ml suspension for injection has been authorised for use in cattle as a hybrid of Nuflor 300 mg/ml solution for injection using the decentralised procedure with Germany as a reference Member State and Austria, Belgium, Bulgaria, Czech Republic, Denmark, France, Greece, Hungary, Ireland, Italy, Lithuania, Luxemburg, the Netherlands, Poland, Portugal, Romania, Slovakia, Spain and the United Kingdom as concerned Member States.
Zdravilo Florgane 300 mg/ml raztopina za injiciranje je bilo odobreno za uporabo pri govedu kot hibrid zdravila Nuflor 300 mg/ml raztopina za injiciranje z decentraliziranim postopkom z Nemčijo kot referenčno državo članico ter Avstrijo, Belgijo, Bolgarijo, Češko, Dansko, Francijo, Grčijo, Madžarsko, Irsko, Italijo, Litvo, Luksemburgom, Nizozemsko, Poljsko, Portugalsko, Romunijo, Slovaško, Španijo in Združenim kraljestvom kot zadevnimi državami članicami.
Risk management or mitigation measures
Obvladovanje tveganja ali omilitveni ukrepi
Relevance of the dose for the development of antimicrobial resistance
Pomen odmerka za razvoj antimikrobske odpornosti
• it is considered there is no increase in the risk of development of antimicrobial resistance;
• Odbor meni, da tveganje za razvoj antimikrobne odpornosti ni povečano.
Strength Animal species
Jakost Živalska vrsta
Considering the data submitted, the Committee concluded as follows on issues raised in the notification received from Germany.
Po preučitvi predloženih podatkov je Odbor glede vprašanj, ki jih je v sporočilu poslala Nemčija, podal zaključke, ki so navedeni v nadaljevanju.
The warnings in the product literature remain appropriate.
Opozorila v navodilih za uporabo zdravila so ustrezna.
List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, applicant in the Member States
Seznam imen, farmacevtskih oblik, jakosti zdravil za uporabo v veterinarski medicini, živalskih vrst, poti uporabe zdravila in predlagateljev v državah članicah
The use of florfenicol in pigs has not generated any significant resistance of the target pathogens.
Uporaba florfenikola pri prašičih ni povzročila nobene pomembne odpornosti ciljnih patogenov.
This applies to both the duration of time necessary to be above the MIC within an entire dosing interval and to the total number of subsequent dosing(s) needed for efficacious treatment.
To velja tako za čas, ki je potreben nad MIK znotraj celotnega intervala odmerjanja, kot tudi za skupno število naknadnih odmerkov, potrebnih za učinkovito zdravljenje.
The pigs enrolled in the study were suffering from mild to moderate respiratory disease which is considered consistent with the field situation where animals are treated as early as possible before signs of swine respiratory disease become severe.
Prašiči, vključeni v študijo, so imeli blago do zmerno bolezen dihal, ki se šteje kot skladna s situacijo na terenu, kjer se živali zdravi čim prej, preden znaki bolezni dihal pri prašičih postanejo resni.
Thus, pharmacokinetic/pharmacodynamic analyses can provide approximation for dose finding only and clinical studies are essential to confirm a proposed dosing scheme.
Farmakokinetične/farmakodinamične analize lahko zato zagotovijo zgolj približek za določitev odmerka, klinične študije pa so ključnega pomena za potrditev predlagane sheme odmerjanja.
The product is presented in four multidose vial sizes of 50 ml, 100 ml, 250 ml and 500ml.
Zdravilo je na voljo v štirih večodmernih vialah po 50 ml, 100 ml, 250 ml in 500 ml.
A single-dose therapy of the individual animal has advantages (less work for the user, fewer treatment errors, less handling of pigs leading to less stress) over a multi-dose therapy and/or oral group therapy.
Zdravljenje posamezne živali z enkratnim odmerkom je koristnejše (manj dela za uporabnika, manj napak pri zdravljenju, manj ravnanja s prašiči, torej manj stresa) od zdravljenja z več odmerki in/ali peroralnega skupinskega zdravljenja.
During the decentralised procedure potential serious risks were identified by Denmark regarding the sustained concentration above the Minimum Inhibitory Concentration (MIC) at the site of infection for the necessary duration.
Med decentraliziranim postopkom je Danska opredelila možna resna tveganja v zvezi z vzdržno koncentracijo nad minimalno inhibitorno koncentracijo (MIK) na mestu okužbe za vnaprej določeno časovno obdobje.
Florfenicol is structurally related to thiamphenicol and has a similar pharmacological profile.
Florfenikol je strukturno povezan s tiamfenikolom in ima podoben farmakološki profil.
Since florfenicol per definition is a time-dependent antimicrobial, T>MIC is the most appropriate pharmacokinetic/pharmacodynamic surrogate.
Ker je florfenikol po definiciji časovno odvisen antimikrob, je T > MIK najprimernejši farmakokinetični/farmakodinamični nadomestek.
Quality, Target animal safety, User safety, Environmental risk and Residues were not assessed in this referral procedure.
V tem napotitvenem postopku kakovost, varnost zdravila za ciljno živalsko vrsto, varnost zdravila za uporabnika, okoljska tveganja in ostanki niso bili obravnavani.
The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Veljavni povzetek glavnih značilnosti zdravila, označevanje in navodila za uporabo so končne različice, ki so nastale med postopkom skupine za usklajevanje.
Evaluation and conclusion on the benefit-risk balance
Vrednotenje in zaključek o razmerju med koristmi in tveganji
Therefore, the CVMP recommended the granting of the extension of the marketing authorisation to the target species pigs for the veterinary medicinal products referred to in annex I for which the valid Summary of Product Characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in annex III.
Odbor CVMP je zato priporočil odobritev razširitve dovoljenja za promet z zdravilom na ciljno vrsto prašičev za zdravila za uporabo v veterinarski medicini, navedena v Prilogi I, katerih veljavni povzetek glavnih značilnosti zdravila, označevanje in navodila za uporabo ostanejo enaki kot končne različice, dogovorjene med postopkom skupine za usklajevanje, kakor je omenjeno v Prilogi III.
Marketing authorisation granted
1 Dovoljenje za promet z zdravilom odobreno
Swine respiratory disease is one of the most important diseases of pig production resulting from infection of susceptible pigs with virus and obligatory and facultative pathogenic bacteria, which require effective therapeutic treatment.
Bolezen dihal pri prašičih je ena najpomembnejših bolezni pri prašičereji, do katere pride zaradi okužbe občutljivih prašičev z virusom ter obveznimi in fakultativnimi patogenimi bakterijami, ki zahteva učinkovito terapevtsko zdravljenje.
The active substance is included in veterinary medicinal products currently licensed in several countries in the European Union for use in cattle and pigs for the treatment of respiratory diseases.
Zdravilno učinkovino vsebujejo zdravila za uporabo v veterinarski medicini, ki so trenutno odobrena v več državah Evropske unije za zdravljenje bolezni dihal pri govedu in prašičih.
However, no evidence based data are available on how long the time over the MIC should be for florfenicol and swine respiratory disease related target organisms.
Kljub temu pa ni na voljo nobenih podatkov na podlagi dokazov o tem, koliko časa nad MIK je treba pustiti za florfenikol in ciljne organizme, povezane z boleznimi dihal pri prašičih.
The application in question, submitted via the decentralised procedure, is a so called “hybrid application” according to Article 13(3) of Directive 2001/82/EC.
Obravnavana vloga, predložena po decentraliziranem postopku, je v skladu s členom 13(3) Direktive 2001/82/ES „hibridna vloga“.
The Committee considered whether the duration of efficacious concentrations lasting less than 2 days after a single application is considered sufficient for treatment of severe respiratory diseases caused by A. pleuropneumoniae and P. multocida in pigs.
Odbor je preučil, ali trajanje učinkovitih koncentracij, ki trajajo manj kot 2 dni po enkratni aplikaciji, zadostuje za zdravljenje resnih bolezni dihal pri prašičih, ki jih povzročata patogena A. pleuropneumoniae in P. multocida.
Florfenicol is bacteriostatic and exerts timedependent activity.
Florfenikol deluje bakteriostatično in v odvisnosti od časa.
The product proved to be non-inferior to an established control product containing florfenicol which is administered twice 48 hours apart.
Zdravilo se je pokazalo kot neinferiorno odobrenemu kontrolnemu zdravilu s florfenikolom, ki se injicira dvakrat v razmiku 48 ur.
France1
Francija1
The Committee considered whether the proposed dose of 22.5 mg/kg IM once may lead to a long subtherapeutic period (e.g. below MIC) and thus to development of florfenicol resistance.
Odbor je proučil, ali lahko predlagani enkratni intramuskularni odmerek 22,5 mg/kg telesne mase povzroči dolgotrajne koncentracije pod terapevtsko ravnjo (npr. pod MIK) in s tem razvoj odpornosti na florfenikol.
Florgane 300 mg/ml suspension for injection differs from the reference veterinary medicinal product by a single administration, a different pharmaceutical form and composition.
Zdravilo Florgane 300 mg/ml raztopina za injiciranje se od referenčnega zdravila za uporabo v veterinarski medicini razlikuje po enkratnem dajanju, drugačni farmacevtski obliki in sestavi.
Summary of product characteristics, labelling and package leaflet
Povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo
These issues remained unsolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination Group for Mutual Recognition and Decentralised Procedures (CMD(v)) was started.
Ker ti pomisleki še niso bili rešeni, je bila zadeva v skladu s členom 33(1) Direktive 2001/82/ES napotena k skupini za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirane postopke - zdravila za uporabo v veterinarski medicini (CMD(v)).
• the data package submitted by the applicant is considered sufficient taking into account the nature of this application for an extension of the marketing authorisation (hybrid application);
• upoštevajoč naravo predložene vloge, sveženj podatkov, ki jih je predložil predlagatelj, zadostuje za razširitev dovoljenja za promet z zdravilom (hibridna vloga);
Based on a GLP-compliant dose titration study using pigs artificially infected with A. pleuropneumoniae two doses of florfenicol were selected for further evaluation in a clinical field study, which was supported by pharmacokinetic/pharmacodynamic analysis.
Na podlagi študije titracije odmerka, skladne z DLP, na prašičih, umetno okuženih s patogenom A. pleuropneumoniae, so izbrali dva odmerka florfenikola za nadaljnje vrednotenje v klinični terenski študiji, ki je bila podprta s farmakokinetično/farmakodinamično analizo.
The Member States concerned failed to reach an agreement in respect of the extension of the marketing authorisation of Florgane 300 mg/ml suspension for injection for cattle to the target species pigs and consequently the matter was referred to the CVMP on 19 April 2012.
Ker zadevne države članice niso uspele doseči soglasja v zvezi z razširitvijo dovoljenja za promet z zdravilom Florgane 300 mg/ml raztopina za injiciranje za govedo na ciljno vrsto prašičev, je bila zadeva 19. aprila 2012 napotena na odbor CVMP.
This referral under Article 33(4) of Directive 2001/82/EC was made due to concerns that the applicant had not satisfactorily demonstrated the clinical efficacy of Florgane 300 mg/ml suspension for injection at a single intramuscular dose of 22.5 mg/kg bw in the treatment of swine respiratory disease.
Napotitveni postopek v skladu s členom 33(4) Direktive 2001/82/ES je bil sprožen zaradi pomislekov, da predlagatelj ni v zadovoljivi meri dokazal klinične učinkovitosti zdravila Florgane 300 mg/ml raztopina za injiciranje pri enkratnem intramuskularnem odmerku 22,5 mg/kg telesne mase za zdravljenje bolezni dihal pri prašičih.
The dose of 30 mg/kg did not prove additional benefit in relation to efficacy compared to the dose of 22.5 mg/kg bw, therefore the latter is justified as recommended treatment dose.
Odmerek 30 mg/kg ni pokazal dodatne koristi v zvezi z učinkovitostjo v primerjavi z odmerkom 22,5 mg/kg telesne mase, zato je 22,5 mg/kg telesne mase upravičeno priporočeni odmerek za zdravljenje.
Whether the risk for the rate of resistance development would be dependent on the dose in this case is not possible to conclude on based on available data.
Na podlagi razpoložljivih podatkov je nemogoče ugotoviti, ali bi bila v tem primeru stopnja razvoja odpornosti odvisna od odmerka.
However, no pharmacokinetic data of the terminal phases are available which could allow for a robust comparison between Florgane 300 mg/ml suspension for injection and conventional formulations in regard to duration of sub-therapeutic concentrations.
Vendar pa ne obstajajo nobeni farmakokinetični podatki o končnih fazah, na podlagi katerih bi lahko zanesljivo primerjali sestavo zdravila Florgane 300 mg/ml raztopina za injiciranje z drugimi običajnimi pripravki glede trajanja koncentracij pod terapevtsko ravnijo.
Pharmacokinetic data suggest that the elimination of the active ingredient is independent of the formulation and the dosage as long as the absorption phase is completed.
Na podlagi farmakokinetičnih podatkov je mogoče sklepati, da izločitev zdravilne učinkovine ni odvisna od sestave in odmerka, v kolikor je bila faza absorpcije zdravila uspešna.
The proposed dose is 22.5 mg florfenicol/kg body weight given by intramuscular administration as a single injection.
Predlagani odmerek je 22,5 mg florfenikola/kg telesne mase, ki se ga daje intramuskularno z enkratnim injiciranjem.
In order to address the concerns raised by the referral, the applicant presented all available efficacy data for Florgane 300 mg/ml suspension for injection for the target species pigs.
Da bi odpravili pomisleke, izpostavljene v napotitvenem postopku, je predlagatelj predložil vse razpoložljive podatke o učinkovitosti za zdravilo Florgane 300 mg/ml raztopina za injiciranje za ciljno vrsto prašičev.
Resistance to florfenicol remains very low among porcine respiratory pathogens while Nuflor Swine Injectable Solution 300 mg/ml has been used for more than one decade in pigs in swine respiratory disease.
Odpornost prašičjih respiratornih patogenov na florfenikol ostaja zelo nizka, čeprav se zdravilo Nuflor Swine 300 mg/ml raztopina za injiciranje že več kot eno desetletje uporablja za zdravljenje bolezni dihal pri prašičih.
No further risk management or mitigation measures are required as a consequence of this referral procedure.
V tem napotitvenem postopku Odbor ni ugotovil, da bi bili potrebni dodatni ukrepi za obvladovanje tveganja ali omilitveni ukrepi.
In a GCP-compliant randomised blinded controlled clinical field study Florgane 300 mg/ml proved to be non-inferior in the treatment of swine respiratory disease associated with A. pleuropneumoniae and P. multocida at both single IM doses of 22.5 mg/kg and 30 mg/kg bw when compared to a control product containing 300 mg florfenicol/ml administered at a dose of 15 mg/kg bw IM twice 48 hours apart.
V randomizirani slepi kontrolirani klinični terenski študiji, skladni z DLP, se je zdravilo Florgane 300 mg/ml izkazalo kot neinferiorno pri zdravljenju bolezni dihal pri prašičih, povezanimi s patogenoma A. pleuropneumoniae in P. multocida, pri obeh enkratnih intramuskularnih odmerkih 22,5 mg/kg in 30 mg/kg telesne mase v primerjavi s kontrolnim zdravilom s 300 mg florfenikola/ml, ki je bilo injicirano intramuskularno v odmerku 15 mg/kg dvakrat v razmiku 48 ur.
Resistance to florfenicol remains very low among porcine respiratory pathogens whereas the active substance has been used for more than one decade in pigs in swine respiratory disease.
Odpornost prašičjih respiratornih patogenov na florfenikol ostaja zelo nizka, čeprav se zdravilna učinkovina že več kot eno desetletje uporablja za zdravljenje bolezni dihal pri prašičih.
For the claimed bacteria species good susceptibility against florfenicol with MIC90 valules for P. multocida and A. pleuropneumoniae of 0.5 µg/ml was determined.
Pri zadevnih vrstah bakterij so zabeležili dobro občutljivost za florfenikol z vrednostmi MIK90 0,5 µg/ml za patogena P. multocida in A. pleuropneumoniae.
Overall, the data package submitted by the applicant is considered sufficient taking into account the nature of this application for an extension of the marketing authorisation (hybrid application).
Upoštevajoč naravo predložene vloge, sveženj podatkov, ki ga je predložil predlagatelj, v splošnem zadostuje za razširitev dovoljenja za promet z zdravilom (hibridna vloga).
The benefit of Florgane 300 mg/ml suspension for injection is that swine respiratory disease associated with susceptible Actinobacillus pleuropneumoniae and Pasteurella multocida can be treated.
Korist zdravila Florgane 300 mg/ml raztopina za injiciranje je, da je mogoče bolezni dihal pri prašičih, povezane z občutljivima patogenoma Actinobacillus pleuropneumoniae in Pasteurella multocida, zdraviti.
This application is an extension to add pigs as a target species to the existing 300 mg florfenicol/ml suspension for injection product authorised for use in cattle.
Ta vloga je razširitev, s katero bi prašiče dodali kot novo ciljno vrsto k obstoječemu zdravilu 300 mg florfenikol/ml raztopina za injiciranje, ki je odobreno za uporabo pri govedu.
This extension application was submitted as a decentralised procedure under Article 13(3) of Directive 2001/82/EC, as amended, to the above-mentioned Member States as for the initial application for cattle.
Ta vloga za razširitev je bila, tako kot začetna vloga za govedo, zgoraj omenjenim državam članicam predložena kot decentralizirani postopek v skladu s členom 13(3) Direktive 2001/82/ES, kot je bila spremenjena.
• the CVMP reviewed all available data submitted by the applicant to support the use of the product in the target species pigs for the treatment of respiratory infections caused by strains of Actinobacillus pleuropneumoniae and Pasteurella multocida susceptible to florfenicol at the dose of 22.5 mg florfenicol/kg body weight given by intramuscular administration as a single injection;
• odbor CVMP je ponovno proučil vse razpoložljive podatke, ki jih je predložil predlagatelj v podporo uporabi zdravila pri ciljni vrsti prašičev za zdravljenje okužb dihal, ki jih povzročajo sevi bakterij Actinobacillus pleuropneumoniae in Pasteurella multocida, ki so občutljive za florfenikol pri odmerku 22,5 mg florfenikola/kg telesne mase, ki se ga daje intramuskularno z enkratnim injiciranjem;