natgillin/translations-raw huggingface dataset:
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Dificlir.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Dificlir, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
When it is swallowed most of the active substance does not get absorbed into the blood stream but acts locally on C. difficile bacteria in the gut.
Ko se pogoltne, se večina zdravilne učinkovine ne vsrka v krvni obtok, ampak deluje lokalno na bakterijo C. difficile v črevesju.
The most common side effects with Dificlir (seen in between 1 and 10 patients in 100) are nausea (feeling sick), vomiting and constipation.
Najpogostejši neželeni učinki zdravila Dificlir (opaženi pri 1 do 10 bolnikih od 100) so navzeja (slabost), bruhanje in zaprtje.
Dificlir must not be used in people who are hypersensitive (allergic) to fidaxomicin or any of the other ingredients.
Zdravila Dificlir ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) fidaksomicin ali katero koli drugo sestavino zdravila.
What benefit has Dificlir shown during the studies?
Kakšne koristi je zdravilo Dificlir izkazalo med študijami?
Why has Dificlir been approved?
Zakaj je bilo zdravilo Dificlir odobreno?
What is the risk associated with Dificlir?
Kakšna tveganja so povezana z zdravilom Dificlir?
The active substance in Dificlir, fidaxomicin, is an antibiotic that belongs to the class of macrocylic antibiotics.
Zdravilna učinkovina v zdravilu Dificlir, fidaksomicin, je antibiotik, ki pripada novi vrsti makrocikličnih antibiotikov.
The CHMP considered the severity of C. difficile infections and the drawbacks of current treatments and concluded that benefits of Dificlir are greater than its risks and recommended that it be given marketing authorisation.
CHMP je proučil resnost okužb z bakterijo C.difficile in slabosti sedanjih načinov zdravljenja ter zaključil, da so koristi zdravila Dificlir večje od z njim povezanih tveganj ter priporočil, da se zanj odobri dovoljenje za promet z zdravilom.
Dificlir has been compared with vancomycin (another antibiotic for C. difficile infections) in two main studies involving a total of 1,147 adult patients with mild to moderately severe C. difficile infection.
Zdravilo Dificlir so primerjali z vankomicinom (drugim antibiotikom za okužbe z bakterijo C. difficile) v dveh glavnih študijah, ki sta skupno vključevali 1 147 odraslih bolnikov z blažjo do zmerno hudo okužbo z bakterijo C. difficile.
At this point, a person is said to be infected with C. difficile.
Takrat velja, da je oseba okužena z bakterijo C. difficile.
Dificlir is used to treat adults with infections of the gut caused by bacteria called Clostridium difficile.
Zdravilo Dificlir se uporablja pri odraslih za zdravljenje okužb črevesja, ki jih povzroča bakterija Clostridium difficile.
For the full list of all side effects reported with Dificlir, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Dificlir, glejte navodilo za uporabo.
Dificlir is a medicine that contains the active substance fidaxomicin.
Dificlir je zdravilo, ki vsebuje zdravilno učinkovino fidaksomicin.
polymerase, which is used to produce the RNA that the bacteria need to make proteins.
Deluje tako, da zavira bakterijski encim, polimerazo RNK, ki se uporablja za tvorbo RNK, ki jo bakterija potrebuje pri tvorbi beljakovin.
This stops the C. difficile bacteria from growing and multiplying.
To preprečuje rast in razmnoževanje bakterije C. difficile.
How has Dificlir been studied?
Kako je bilo zdravilo Dificlir raziskano?
The CHMP considered that Dificlir was effective in curing C. difficile infections and was generally well tolerated with side effects that are similar to vancomycin.
CHMP je menil, da je zdravilo Dificlir učinkovito pri zdravljenju okužb z bakterijo C. difficile, bolniki zdravljenje na splošno dobro prenašajo z neželenimi učinki, podobnimi tistim pri vankomicinu.
What is Dificlir used for?
Za kaj se zdravilo Dificlir uporablja?
Dificlir was at least as effective as vancomycin in curing C. difficile infection.
Dificlir je bil pri zdravljenju okužbe z bakterijo C. difficile vsaj tako učinkovit kot vankomicin.
How is Dificlir used?
Kako se zdravilo Dificlir uporablja?
How does Dificlir work?
Kako zdravilo Dificlir deluje?
6 February 2012
6. februar 2012
The Committee adopted a positive opinion by majority on 10 November 2011.
Odbor je sprejel pozitivno mnenje z večino dne 10. novembra 2011.
The referral procedure started on 11 November 2009.
Napotitveni postopek se je začel 11. novembra 2009.
The final opinion was converted into a Decision by the European Commission on 6 February 2012.
Končno mnenje je bilo dne 6. februarja 2012 spremenjeno v odločbo Evropske komisije.
The Committee appointed Dr Karolina Törneke as rapporteur and Dr Michael Holzhauser-Alberti as co-rapporteur.
Odbor je imenoval dr. Karolino Törneke za poročevalko in dr. Michaela Holzhauser-Albertija za soporočevalca.
Article 34 of Directive 2001/82/EC
34. člen Direktive 2001/82/ES.
Oral explanations were given on 4 May 2011.
Ustna pojasnila so bila podana 4. maja 2011.
International non-proprietary name (inn): benazepril hydrochloride
Mednarodno nelastniško ime (inn): benazepril hidroklorid
Fortekor and associated names
za zdravilo Fortekor in povezana imena
Written explanations were provided by the marketing authorisation holders on 24 May 2010 and 6 January 2011.
Imetniki dovoljenj za promet z zdravilom so podali pisna pojasnila 24. maja 2010 in 6. januarja 2011.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended product information in Annex III.
Seznam zadevnih imen izdelkov je podan v Prilogi I. Znanstveni zaključki so na voljo v Prilogi II, skupaj z dopolnjenimi informacijami o zdravilu v Prilogi III.
In line with the principles of referrals under Article 34(1) of Directive 2001/82/EC, on 16 September 2010 Sweden sent a revised referral notification under Article 34(1) of Directive 2001/82/EC and extended the scope of the referral procedure to all Fortekor and associated names tablet strengths and formulations.
V skladu z načeli napotitev po členu 34(1) Direktive 2001/82/ES, je Švedska dne 16. septembra 2010 poslala revidirano obvestilo o napotitvi po členu 34(1) Direktive 2001/82/ES in razširila obseg napotitvenega postopka na vse jakosti in farmacevtske oblike tablet Fortekor in povezanih imen.
Fortekor and associated names is a veterinary medicinal product containing benazepril hydrochloride presented in 2.5 mg, 5 mg and 20 mg flavoured tablets and 5 mg and 20 mg film-coated tablets intended for use in dogs and cats.
Fortekor in povezana imena so zdravila za uporabo v veterinarski medicini, ki vsebujejo benazepril hidroklorid v aromatiziranih tabletah po 2,5 mg, 5 mg in 20 mg ter v filmsko obloženih tabletah po 5 mg in 20 mg, namenjenih za uporabo pri psih in mačkah.
The product is intended for the treatment of heart failure in dogs and/or the treatment of chronic kidney disease in cats and dogs, and the approved indications and target species varied between the Member States.
Ta izdelek je namenjen za zdravljenje srčnega popuščanja pri psih in/ali za zdravljenje kronične ledvične bolezni pri mačkah in psih, ter za odobrene indikacije in ciljne vrste, ki se razlikujejo med državami članicami.
Benazeprilat is a highly potent and selective inhibitor of angiotensin converting enzyme, thus preventing the conversion of inactive angiotensin I to active angiotensin II and thereby also reducing synthesis of aldosterone.
Benazeprilat je visoko učinkovit in selektiven zaviralec angiotenzinske konvertaze, ki na ta način preprečuje pretvorbo neaktivnega angiotenzina I v aktivni angiotenzin II in s tem tudi zmanjšuje sintezo aldosterona.
Due to the divergent decisions taken by Member States concerning the authorisation of Fortekor and associated names (5 mg benazepril hydrochloride film-coated tablet) and differences between the summary of product characteristics of the product as authorised in the Member States, the issue was referred on 16 October 2009 by Sweden to the CVMP under Article 34(1) of Directive 2001/82/EC.
Zaradi različnih odločitev, ki so jih države članice sprejele v zvezi z odobritvijo zdravila Fortekor in povezanih imen (filmsko obložena tableta s 5 mg benazepril hidroklorida) ter razlik med povzetki glavnih značilnosti zdravila, ki so jih odobrile države članice, je Švedska dne 16. oktobra 2009 zadevo napotila na odbor CVMP v skladu s členom 34(1) Direktive 2001/82/ES.
An ad-hoc expert group meeting was held on 10 October 2011 and the marketing authorisation holders attended the meeting for an oral explanation.
Zasedanje ad-hoc izvedenske skupine je potekalo 10. oktobra 2011, imetniki dovoljenj za promet z zdravilom pa so se zasedanja udeležili, da so podali ustna pojasnila.
Based on the assessment of the currently available data and further to a consultation with the ad-hoc expert group, the CVMP considered that the benefit-risk balance for Fortekor and associated names remains positive, except for the chronic kidney disease in dogs, subject to variation of the marketing authorisations in accordance with the recommended product information.
Na podlagi ocene trenutno razpoložljivih podatkov in po posvetu z ad-hoc izvedensko skupino je odbor CVMP menil, da razmerje med tveganji in koristmi za zdravilo Fortekor in povezana imena ostaja pozitivno, z izjemo kronične ledvične bolezni pri psih, ki se v dovoljenjih za promet z zdravilom spremeni v skladu s priporočenimi informacijami o zdravilu.
Benazepril hydrochloride is a prodrug hydrolysed in vivo to its active metabolite, benazeprilat.
Benazepril hidroklorid je predzdravilo, ki se hidrolizira in vivo v svoj aktivni presnovek, benazeprilat.
holders' oral explanations to the Committee, the CVMP, at its May 2011 meeting, agreed that an ad-hoc expert group should be consulted regarding the scientific evidence base for angiotensin converting enzyme inhibitor in the treatment of chronic kidney disease in dogs.
posvetovati z ad-hoc izvedensko skupino v zvezi z znanstvenimi izsledki o zaviralcih angiotenzinske konvertaze pri zdravljenju kronične ledvične bolezni pri psih.
Opinion following an Article 34 referral for Fortekor and associated names EMA/965903/2011
Mnenje v zvezi z napotitvijo v skladu s členom 34 za zdravilo Fortekor in povezana imena stran 2/2
The four remaining studies are summarised below.
Preostale štiri študije so povzete spodaj.
Member State EU/EEA
Država članica EU /EGP
Special warnings, if necessary
Posebna opozorila, če so potrebna
The Reference Member State was Ireland and the Concerned Member States were Austria, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Greece, Spain, Finland, France, Hungary, Iceland, Latvia, Lithuania, Malta, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia and Sweden.
Referenčna država članica je bila Irska, zadevne države članice pa Avstrija, Bolgarija, Ciper, Češka republika, Danska, Estonija, Grčija, Španija, Finska, Francija, Madžarska, Islandija, Latvija, Litva, Malta, Nizozemska, Norveška, Poljska, Portugalska, Romunija, Slovaška, Slovenija in Švedska.
It is noted that the study (2002) predates the introduction of that guideline (2005).
Omeniti je treba, da je bila študija (2002) izvedena pred objavo te smernice (2005).
Therefore, this scenario was not considered for sheep.
Ta scenarij zato za ovce ni bil obravnavan.
This method is however not considered suitable for substances with a log Pow above 4.
Vendar pa ta metoda ni ustrezna za snovi, ki imajo log Pow nad 4.
Although this study was well conducted other studies cannot be disregarded unless there is a sound reason for doing so (e.g. evidence of mistakes).
Četudi je bila ta študija izvedena dobro, pa ni mogoče zanemariti drugih študij, razen če obstaja očiten razlog za to (npr. prisotnost napak).
Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom
Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ Združeno Kraljestvo
However, this study is not available and cannot be requested in this referral.
Vendar pa ta študija ni na voljo in je v tem napotitvenem postopku ni mogoče zahtevati.
The log Pow of 4.4 can therefore only be considered as an indicator of the actual value.
Posledično je mogoče vrednost log Pow 4,4 upoštevati le kot približnega pokazatelja dejanske vrednosti.
The Committee noted that the final version of the product information achieved during the Coordination Group procedure at day 210 includes specific warnings concerning conditions of use in dairy cattle.
Odbor je opozoril, da končna različica informacij o zdravilu, ki je bila sprejeta med postopkom usklajevalne skupine na 210. dan, vključuje posebna opozorila glede pogojev uporabe pri kravah molznicah.
Benefits have not been subject of this referral; they were considered in the preceding decentralised procedure.
Koristi niso bile predmet tega napotitvenega postopka, saj so bile obravnavane v predhodnem decentraliziranem postopku.
Cattle, sheep and pigs
Govedo, ovce in prašiči
During the decentralised procedure it was agreed that the authorisation of the generic product under the name "Dectomax" will not be issued until the reference product under the name "Dectomax" has either been withdrawn or renamed.
Med decentraliziranim postopkom je bilo dogovorjeno, da dovoljenje za promet generičnega zdravila z imenom „Dectomax“ ne bo izdano, dokler referenčno zdravilo z imenom „Dectomax“ ne bo umaknjeno ali preimenovano.
The product has claims for persistent efficacy ranging from 18 to 42 days.
Učinek zdravila naj bi trajal v razponu od 18 do 42 dni.
The following MRLs have been established in the EU for the active substance doramectin (Table 1 of the Annex to Regulation (EU) No 37/2010 for all mammalian food producing species:
Za zdravilno učinkovino doramektin so v EU določene naslednje mejne vrednosti ostankov (tabela 1 priloge k Uredbi (EU) št. 37/2010 za vse vrste sesalcev za proizvodnjo živil):
The weights of animals were below 250 kg. Only injection sites (500-600 g) were sampled.
Mase živali so bile pod 250 kg. Vzorčena so bila samo mesta injiciranja (500-600 g).
The applicant provided a targeted Phase II environmental risk assessment.
Predlagatelj je predložil ciljno usmerjeno oceno tveganja za okolje faze II.
Before addressing the issues of disagreement the following two changes to the initial application that were made during the decentralised procedure and the CVMP referral procedure should be noted:
Pred obravnavanjem spornih vprašanj je treba opozoriti na naslednji dve spremembi prvotne vloge, do katerih je prišlo med decentraliziranim postopkom in napotitvenim postopkom pri CVMP:
The product is applied by a single subcutaneous or intramuscular injection.
Zdravilo se daje z enkratno subkutano ali intramuskularno injekcijo.
It protects pigs against infection or reinfection with Sarcoptes scabiei for 18 days.
Prašiče 18 dni varuje pred okužbo ali ponovno okužbo z zajedavcem Sarcoptes scabiei.
The need for repeat treatments is reduced relative to other anthelmintic products.
Potreba po ponovnih zdravljenjih je zmanjšana v primerjavi z drugimi antihelmintiki.
The following text is proposed in section 4.5 (special precautions for use):
Predlaga se vključitev naslednjega besedila v oddelek 4.5 (posebni previdnosti ukrepi):
Additional benefits of this product are the same as the reference product.
Dodatne koristi tega zdravila so enake kot pri referenčnem zdravilu.
Both compounds share a wide spectrum of antiparasitic activity and produce a similar paralysis in nematodes and parasitic arthropods.
Obe spojini imata širok spekter antiparazitskega delovanja in tvorita podobno paralizo pri nematodih in parazitskih artropodih.
No data on the nature and rates of metabolites are available.
Podatki o naravi in ravneh presnovkov niso na voljo.
All except one were GLP studies and were carried out with the same formulation (plus or minus radioactive tracer).
Vse študije, razen ene, so bile skladne z dobro laboratorijsko prakso in so bile izvedene z isto formulacijo (z radioaktivnim sledilom ali brez njega).
It cannot be excluded that actual injection sites were missed in this study.
Ni mogoče izključiti možnosti, da so bila pri tej študiji dejanska mesta injiciranja zgrešena.
Injection sites at 35 and 56 days were not assayed.
Vzorčenje na mestu injiciranja 35. in 56. dan ni bilo izvedeno.
Conclusions regarding the environmental impact
Zaključki v zvezi z vplivom na okolje
However, no bioaccumulation study was provided; also no assessment of secondary poisoning was performed.
Vendar pa študija biološkega kopičenja ni bila posredovana, prav tako pa ni bila izvedena ocena sekundarne zastrupitve.
In addition, the studies showed high variability of residues in injection site samples and none fully comply with current guidelines.
Poleg tega so študije pokazale veliko raznolikost ostankov pri vzorcih, vzetih na mestu injiciranja, nobena pa ni povsem skladna z veljavnimi smernicami.
The valid Summary of Product Characteristics, Labelling and Package Leaflet are the final versions achieved during the Coordination Group procedure with the following amendments:
Veljavni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so zadnje različice, ki so bile pripravljene v postopku usklajevalne skupine z naslednjimi dopolnili:
During the procedure, there was disagreement between the Reference Member State and Concerned Member States on the data presented to support the environmental risk assessment and the proposed withdrawal period for cattle.
Med postopkom je prišlo do nesoglasja med referenčno državo članico in zadevnimi državami članicami glede podatkov, predloženih v podporo oceni tveganja za okolje, in predlagane karence za govedo.
This was not part of this referral and therefore not considered by the CVMP.
To ni bil del tega napotitvenega postopka, zato tega CVMP tudi ni obravnaval.
The CVMP considered that the test method for the determination of the n-octanol/water partition coefficient was not appropriate.
CVMP je zato menil, da testna metoda za določitev porazdelitvenega koeficienta n-oktanol/voda ni bila ustrezna.
Significant differences between studies were observed (range from 5 to 68-fold) which cannot be explained by different sample weights of injection sites.
Opažene so bile pomembne razlike med študijami (v razponu od 5- do 68-kratnika), ki jih ni mogoče razložiti z različnimi masami vzorcev, odvzetih na mestu injiciranja.
Residues were found to be highly variable between animals.
Ostanki so se med živalmi zelo razlikovali.
The study report provided is very brief and the animal weights were not provided.
Predloženo poročilo o študiji je zelo kratko in ne vsebuje telesnih mas živali.
The internal and external parasites indicated for this product are recognised as causing significant loss of production and negatively impact on animal welfare.
Notranji in zunanji zajedavci, za katere je to zdravilo indicirano, povzročajo veliko izgubo proizvodnje in negativno vplivajo na zdravje živali.
Based on the data from the last study a withdrawal period of 54 days could be calculated.
Na osnovi podatkov iz zadnje študije je bilo mogoče izračunati karenco 54 dni.
The groups included more animals than the minimum number recommended in the withdrawal period guideline (EMEA/CVMP/036/95/final): 6 animals per groups instead of 4.
Skupine so vključevale več živali, kot jih je najmanj priporočenih v smernici o karenci (EMEA/CVMP/036/95/final): 6 živali v skupini namesto 4.
Therefore, appropriate risk mitigation measures are considered necessary, as specified in the product information.
Iz tega razloga je bilo ocenjeno, da so nujni ustrezni ukrepi za zmanjševanje tveganja, kot so navedeni v informacijah o zdravilu.
However, in view of the variability seen across the studies, the fact that none of the studies were in full compliance with the current guideline, and that in a number of studies residue levels remained above the MRL at the last timepoint, it was considered appropriate to add a safety margin of 30% to compensate for the uncertainties associated with the overall data package.
Vendar pa je bil ob upoštevanju razhajanj med študijami, dejstva, da nobena od študij ni bila povsem skladna z veljavno smernico, in dejstva, da so bili pri številnih študijah ob zadnji časovni točki vzorčenja ostanki še vedno nad mejno vrednostjo ostankov za mišičje, sprejet zaključek, da se doda varnostna rezerva 30 % za izravnavo negotovosti, povezanih s celotnim naborom podatkov.
CATTLE:
GOVEDO:
This study was considered the most appropriate study on which to base a withdrawal period for meat and offal in cattle, although all relevant data should be taken into account in the assessment.
Ta študija je bila ocenjena kot najustreznejša študija, ki bi služila kot osnova za določitev karence za meso in drobovino pri govedu, vendar pa je treba pri vrednotenju upoštevati vse zadevne podatke.
As for the benefits, quality of the product was not discussed by CVMP as part of this referral.
Kar zadeva koristi, CVMP v okviru tega napotitvenega postopka ni razpravljal o kakovosti zdravila.
The application was submitted in accordance with the Article 13(1) of the Directive 2001/82/EC (i.e. an application for a generic product).
Vloga je bila predložena v skladu s členom 13(1) Direktive 2001/82/ES (tj. vloga za generično zdravilo).
Several studies and published literature on the toxicity to dung fauna were available.
Na razpolago je bilo več študij in objavljena literatura o strupenosti za organizme, prisotne v gnoju.
The product has dual action against endo- and ecto-parasites and may reduce the number of treatments with different pharmaceutical products.
Zdravilo ima dvojni učinek proti notranjim in zunanjim parazitom in lahko zmanjša število zdravljenj z drugimi farmacevtskimi zdravili.
For the run-off scenario, as the highest PECcattle (0.84 µg/kg) is higher than the highest PECsheep (0.48 µg/kg), the conclusion from the cattle can be extrapolated to sheep.
Ker je pri scenariju odtekanja najvišja vrednost PKOgovedo (0,84 µg/kg) višja od najvišje vrednosti PKOovce (0,48 µg/kg), je zaključke pri govedu mogoče ekstrapolirati na ovce.
After refinement of PECsw using the FOCUS model as recommended by CVMP guideline CVMP/ERA/418282/2005, it was concluded that aquatic organisms were not at risk from doramectin entering surface water bodies via run-off.
Po izboljšavi PKOpovršinske vode z modelom FOCUS, kot priporoča smernica CVMP/ERA/418282/2005, je bilo ugotovljeno, da vodni organizmi niso izpostavljeni tveganju, da bi doramektin vstopil v vodna telesa površinske vode z odtekanjem.
Two of the residue studies were carried out using a different route of administration than the intended use of the product and were therefore not considered relevant for the evaluation.
Dve študiji ostankov sta bili izvedeni z drugačno potjo uporabe, kot je predvidena za uporabo zdravila, zato je bilo ocenjeno, da nista ustrezni za vrednotenje.
Doramectin is an antiparasitic agent, isolated from the fermentation of selected strains derived from the soil organism Streptomyces avermitilis.
Doramektin je antiparazitik, izoliran pri fermentaciji izbranih sevov, ki izvirajo iz talnega organizma Streptomyces avermitilis.
An ERA was performed by the applicant in accordance with the VICH guidelines for Phase I and Phase II assessment adopted by the CVMP (CVMP/VICH/592/98-FINAL, CVMP/VICH/790/03-final) as well as the CVMP guideline on Environmental Impact Assessment for Veterinary Medicinal Products in support of the VICH Guidelines GL6 and GL38 (CVMP/ERA/418282/2005-corr).
Oceno tveganja za okolje je predlagatelj izvedel v skladu s smernicami VICH za oceno faze I in faze II, ki jih je sprejel CVMP (CVMP/VICH/592/98-FINAL, CVMP/VICH/790/03-final), in smernico CVMP o oceni vpliva zdravil za uporabo v veterinarski medicini na okolje v podporo smernic VICH GL6 in GL38 (CVMP/ERA/418282/2005-corr).