FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore the relevance of the bibliographical data regarding Eqvalan to the test product cannot be confirmed.
Slovenian: Zato ustreznosti bibliografskih podatkov o zdravilu Eqvalan za testni izdelek ni mogoče potrditi.
English: It is known that there is a potential resistance build up to ivermectin in Parascaris equorum, however the highest number of P. equorum may be found in grazing horses 3-18 months old.
Slovenian: Znano je, da obstaja možnost razvoja odpornosti pri vrsti Parascaris equorum na ivermektin, vendar pa je največje število P. equorum mogoče najti pri konjih, starih med 3 in 18 meseci, ki se pasejo.
English: If it is assumed that the tables submitted in the response dossier refer to the results from the field study submitted in the original dossier, then these data are inadequate and therefore irrelevant due to the following reasons:
Slovenian: Če predpostavimo, da se tabele, ki so bile predložene v dokumentaciji odgovora, nanašajo na rezultate terenske raziskave, ki so bili predloženi v izvirni dokumentaciji, so ti podatki neustrezni in jih posledično ni mogoče upoštevati iz naslednjih razlogov:
English: For Parascaris type eggs, the results were 50% by day 3 and 65.2% by day 8.
Slovenian: Za jajčeca rodu Parascaris je bilo 3. dne zmanjšanje 50 %, 8. dan pa 65,2 %.
English: ANNEX I NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER
Slovenian: DODATEK I IME, FARMACEVTSKA OBLIKA, JAKOST ZDRAVILA, ŽIVALSKE VRSTE, NAČINI UPORABE IN IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: CONDITION FOR THE LIFTING OF THE SUSPENSION
Slovenian: POGOJ ZA PREKLICA UMIKA
English: For dose confirmation studies, ‘at least two controlled or, where appropriate, critical dose confirmation studies ….. are recommended.'
Slovenian: Za raziskave za določitev odmerka velja, da »sta priporočljivi vsaj dve kontrolirani ali, kjer ustreza, kritični raziskavi za določitev odmerka«.
English: The number of horses with an adequate infection pretreatment is impossible to determine as no negative control group was included.
Slovenian: Nemogoče je določiti število konjev z ustreznim predhodnim zdravljenjem okužb, saj raziskava ni vsebovala negativne kontrolne skupine.
English: - Although non-inferiority was demonstrated to Eqvalan, this is not a recognised measure of efficacy of a new product.
Slovenian: - Čeprav je bila dokazana enakovrednost zdravilu Eqvalan, to ni priznano merilo učinkovitosti novega izdelka.
English: Therefore, this product would not be considered interchangable with other ivermectin containing products already on the market.
Slovenian: Posledično tega izdelka ne bi bilo mogoče obravnavati kot medsebojno zamenljivega z drugimi izdelki, ki vsebujejo ivermektin in so že na trgu.
English: The current application cannot be considered satisfactory as there is no scientific basis on which to grant an authorisation with the proposed SPC.
Slovenian: Sedanje vloge ni mogoče oceniti kot zadovoljive, saj ni znanstvene osnove, na podlagi katere bi bilo mogoče odobriti dovoljenje s predlaganim Povzetkom glavnih značilnosti zdravila (SPC).
English: The bioequivalence with the originator product should be demonstrated by appropriate bioavailability study or adequate data should be provided with regard to residues and efficacy for this kind of application and the results of such study or such data should be submitted to the relevant national authority for further assessment.
Slovenian: Bioekvivalenco z originatorskim izdelkom mora potrditi ustrezna raziskava biološke uporabnosti oziroma predložiti je treba ustrezne podatke o ostankih in učinkovitosti za tovrstno uporabo, rezultate takšne raziskave ali takšne podatke pa je treba predložiti ustreznemu državnemu organu v nadaljnjo presojo.
English: The Marketing Authorisation Holder reexamined the data from this study and stated that on day 6 after treatment no small nor large strongyle larvae were detected in a minimum amount of 25 gram faeces indicating 100% efficacy for all animals, and the recalculated effectiveness against Strongylides is >> 90% on 2 and 7 days after treatment.
Slovenian: Imetnik dovoljenja za promet je znova preučil podatke iz te raziskave in izjavil, da 6. dan po zdravljenju v minimalni količini blata 25 gramov ni bilo več ličink ne malih ne velikih strongilidov, kar kaže na 100 % učinkovitost za vse živali, preračunana učinkovitost proti strongilidom za 2. in 7. dan po zdravljenju pa je >> 90 %.
English: Based on the following, interchangeability with other ivermectin containing products cannot be accepted:
Slovenian: Na podlagi naslednjega ni mogoče sprejeti medsebojne zamenljivosti z drugimi izdelki, ki vsebujejo ivermektin:
English: The statement ‘The treatment of gastrointestinal endoparasite infections in horses' implies that all gastrointestinal endoparasite infections in horses are treated with this product; ‘particularly' implies that the product has a specific action against those species listed.
Slovenian: Iz navedbe „Zdravljenje gastrointestinalnih endoparazitskih okužb pri konjih“ sledi, da se s tem zdravilom zdravijo vse gastrointestinalne endoparazitske okužbe pri konjih; „še zlasti“ izraža, da ima izdelek poseben učinek proti navedenim vrstam.
English: Even the amended indication for the treatment of gastrointestinal endoparasitic infections in horses has not been demonstrated by the data provided.
Slovenian: Tudi spremenjene indikacije za zdravljenje gastrointestinalnih endoparazitskih okužb pri konjih predloženi podatki ne dokazujejo.
English: Without necropsy or a large sample size, it is impossible to draw any meaningful conclusions from this study regarding the efficacy of Equimectin.
Slovenian: Brez nekropsije ali velikega vzorca ni mogoče priti do merodajnih zaključkov iz te raziskave glede učinkovitosti zdravila Equimectin.
English: - The dose-limiting parasite had not been specified or selected.
Slovenian: - Zajedavci, ki omejujejo uporabo odmerka, niso bili določeni ali izbrani.
English: Relative reductions for the number of eggs per gram of faeces for the test product were calculated as 88.2% against Strongylus type eggs on day 3, and 88.2% at day 8.
Slovenian: Relativno zmanjšanje števila jajčec rodu Strongylus v gramu iztrebkov za testni izdelek je bilo 3. dan 88,2 % in 8. dan 88,2 %.
English: This does not comply with the recommendations of the current guidance document (CVMP/VICH/832/99), ‘where pharmacokinetic parameters cannot demonstrate a relationship with effectiveness, two dose confirmation studies using the dose limiting parasite for therapeutic claims ….. will be needed.'
Slovenian: To ni v skladu s priporočili veljavne smernice (CVMP/VICH/832/99), po kateri sta »v primeru, da farmakokinetični parametri ne morejo dokazati povezave z učinkovitostjo, za uveljavljani terapevtski učinek potrebni dve raziskavi za določitev odmerka na zajedavcih, ki omejujejo odmerek«.
English: A single administration of 0.2 mg ivermectin per kg of bodyweight.
Slovenian: En odmerek 0,2 mg ivermektina na kg telesne mase.
English: The Committee, having considered the matter, concluded that on the basis of the available data for Equimectin bioequivalence with the reference product has not been shown.
Slovenian: Odbor je po presoji zadeve sklenil, da na osnovi razpoložljivih podatkov o zdravilu Equimectin bioekvivalenca z referenčnim izdelkom ni bila dokazana.
English: - The number of horses recruited was too low to produce meaningful results.
Slovenian: - Število preučevanih konj je bilo prenizko, da bi bili rezultati merodajni.
English: Therefore, if the product is administered at the recommended dose rate, there is the possibility of lack of efficacy and the potential for anthelmintic resistance.
Slovenian: Posledično obstaja v primeru, ko se zdravilo daje ob upoštevanju priporočenega odmerka, možnost neobstoja učinkovitosti ter potencial za razvoj odpornosti na antihelmintike.
English: Ivermectin containing pastes/oral gels for horses are well established on the market and the prescriber/animal owner would expect Equimectin to be interchangeable with other available products of the avermectin class.
Slovenian: Paste/peroralni geli z ivermektinom za konje so dobro uveljavljeni na trgu, zato bi predpisovalec zdravila/lastnik živali pričakoval, da je zdravilo Equimectin medsebojno zamenljivo z drugimi razpoložljivimi izdelki iz razreda avermektinov.
English: During the referral procedure, it has been established that the submitted bioequivalence study was inadequate to demonstrate bioequivalence (as defined in current guidance EMEA/CVMP/016/00-corrFINAL), however from the comparative pharmacokinetic data it is possible that the test product is systemically less bioavailable than the reference product.
Slovenian: Med postopkom napotitve je bilo ugotovljeno, da predložena bioekvivalenčna raziskava ni ustrezna, da bi lahko dokazala bioekvivalenco (kot jo določa veljavna smernica EMEA/CVMP/016/00-corrFINAL), vendar pa je glede na primerjalne farmakokinetične podatke mogoče, da je testni izdelek sistemsko biološko manj uporaben od referenčnega izdelka.
English: These results were below the accepted 90% or higher and, as there was no control group to compare the differences in parasite counts statistically, which should be significant at p<0.05, it is not possible to determine the efficacy of Equimectin from this study.
Slovenian: Ti rezultati so bili pod sprejetimi 90 % ali več, ker pa ni bilo kontrolne skupine za statistično primerjavo razlik v številu zajedavcev, ki bi naj bile statistično značilne s p < 0,05, iz te raziskave ni mogoče določiti učinkovitosti zdravila Equimectin.
English: The documentation submitted with this application consists of literature referring to the use of the originator product Eqvalan, a comparative pharmacokinetic study using Equimectin and Eqvalan, and a supplementary clinical field study.
Slovenian: Dokumentacija, ki je bila predložena s to vlogo, obsega literaturo v zvezi z uporabo originatorskega izdelka Eqvalan, primerjalno farmakokinetično raziskavo zdravil Equimectin in Eqvalan ter dodatno klinično terensko raziskavo.
English: - The principle criteria used for a comparison of effect is egg count reduction/larval identification or parasite counts in dose confirmation studies.
Slovenian: - Načelni kriterij, uporabljen za primerjavo učinka, je zmanjšanje števila jajčec/identifikacija ličink ali število zajedavcev v raziskavah za določitev odmerka.
English: It is not practical for an SPC for an equine wormer to only indicate use of the product against 5 specific parasites that do not include the important Strongylus genus in horses, but to imply that the product has efficacy against a wider population of parasites.
Slovenian: Ni primerno, da SPC antiparazitika za konje navaja uporabo izdelka samo proti 5 specifičnim zajedavcem, med katerimi ni za konje pomembnega rodu Strongylus, pri čemer pa iz drugih navedb izhaja, da je izdelek učinkovit proti širši populaciji zajedavcev.
English: Efficacy could be claimed if effectiveness against each parasite declared on the labelling was at 90% or above based on calculation of geometric means and there was a statistically significant difference in parasite numbers between control and treated horses.
Slovenian: Učinkovitost bi bilo mogoče uveljavljati, če bi bila učinkovitost proti posameznemu zajedavcu, označenemu na ovojnini, 90 % ali več, izračunana na podlagi geometričnih povprečij, ter če bi bila razlika med številom zajedavcev pri konjih v kontrolni skupini in pri zdravljenih konjih statistično značilna.
English: There is no reference in the Marketing Authorisation Holder's responses to the study that generated the results tables.
Slovenian: V odgovorih imetnika dovoljenja za promet ni sklicevanja na raziskavo, iz katere izhajajo tabele z rezultati.
English: - Based on the type of study conducted, the background exposure of the ponies included in the trial was not stated therefore the adequacy of the infections cannot be documented.
Slovenian: - V odvisnosti od vrste izvedene raziskave ni bila podana obremenitev v okolju, kateri so bili izpostavljeni poniji, ki so bili vključeni v raziskavo, zato ustreznosti okužb ni mogoče dokumentirati.
English: The dose of Eqvalan was found to be 10% higher in the field trial than indicated.
Slovenian: Odmerek zdravila Eqvalan pri terenski raziskavi je bil 10 % večji od navedenega.
English: No data were provided concerning the efficacy against ectoparasites.
Slovenian: Podatki o učinkovitosti proti ektoparazitom niso bili predloženi.
English: The effect against e.g. the large strongyles that are important parasites in the horse is not supported by the presented data and moreover, as the effect on the L4 stage of the small strongyles is not substantiated, the period between necessary prophylactic deworming will be significantly shortened.
Slovenian: Predloženi podatki ne potrjujejo učinka proti npr. velikim strongilidom, ki so pomembni zajedavci pri konju, poleg tega pa se bo interval med potrebnimi profilaktičnimi zatiranji notranjih zajedavcev bistveno skrajšal, saj učinek proti razvojni stopnji L4 malih strongilidov ni dokazan.
English: - The tables included in the response dossier do not indicate which parasites are referred to, and there is no break down of species of parasite.
Slovenian: - Iz tabel, ki so vključene v dokumentaciji odgovora, ni razvidno, za katere zajedavce veljajo, prav tako ni razdelitve po vrstah zajedavcev.
English: The results were not divided for each parasite species.
Slovenian: Rezultati niso bili razdeljeni glede na vrste zajedavcev.
English: - The test product demonstrated lower bioavailability compared to Eqvalan, the cited reference product, during the bioequivalence study, and the test product was administered at greater than the recommended treatment dose in the field study.
Slovenian: - Testni izdelek je med bioekvivalenčno raziskavo izkazal manjšo biološko uporabnost od zdravila Eqvalan, ki je naveden kot referenčni izdelek, poleg tega pa je bil uporabljeni odmerek testnega izdelka pri terenski raziskavi večji od priporočenega odmerka za zdravljenje.
English: Equimectin Oral gel
Slovenian: Equimectin Peroralni gel mg/g
English: January 2007
Slovenian: Nizozemska
English: It is used to treat adults and children (including newborn babies) who have:
Slovenian: Uporablja se za zdravljenje odraslih in otrok (vključno novorojenčkov), ki imajo:
English: Studies in adults
Slovenian: Študije pri odraslih
English: Studies in children
Slovenian: Študije pri otrocih
English: This overview was last updated in 06-2019.
Slovenian: Povzetek je bil nazadnje posodobljen 06-2019.
English: ‘Complicated' means that the infection is difficult to treat;
Slovenian: „Zapletena okužba“ pomeni, da jo je težko zdraviti;
English: Further information on Zinforo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/zinforo
Slovenian: Nadaljnje informacije o zdravilu Zinforo so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/zinforo
English: What measures are being taken to ensure the safe and effective use of Zinforo?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Zinforo?
English: Zinforo received a marketing authorisation valid throughout the EU on 23 August 2012.
Slovenian: Za zdravilo Zinforo je bilo 23. avgusta 2012 izdano dovoljenje za promet, veljavno po vsej EU.
English: However, as there were uncertainties about the effects of Zinforo in patients with certain very severe infections these effects will be investigated in further studies.
Slovenian: Kljub temu bodo zaradi negotovosti glede učinkov zdravila Zinforo pri bolnikih z določenimi zelo resnimi okužbami ti učinki raziskani v nadaljnjih študijah.
English: • community-acquired pneumonia (an infection of the lungs that is caught outside of hospital).
Slovenian: • zunajbolnišnično pljučnico (okužbo pljuč, pridobljeno zunaj bolnišnice).
English: Why is Zinforo authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Zinforo odobreno v EU?
English: What is Zinforo and what is it used for?
Slovenian: Kaj je zdravilo Zinforo in za kaj se uporablja?
English: Prescribers should consider official guidance on the appropriate use of antibiotics.
Slovenian: Zdravniki, ki predpisujejo zdravilo, morajo upoštevati uradne smernice za ustrezno uporabo antibiotikov.
English: The Agency decided that Zinforo's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Agencija je zaključila, da so koristi zdravila Zinforo večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: In children and adolescents weighing less than 33 kilograms, the dose depends on the patient's weight.
Slovenian: Pri otrocih in mladostnih, ki tehtajo manj kot 33 kilogramov, je odmerek odvisen od bolnikove telesne mase.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zinforo have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila Zinforo, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: For some serious skin infections, the recommended dose is 600 mg every 8 hours, with each infusion lasting 120 minutes.
Slovenian: Pri nekaterih resnih okužbah kože znaša priporočeni odmerek 600 mg vsakih osem ur, pri čemer vsako infundiranje traja 120 minut.
English: What benefits of Zinforo have been shown in studies?
Slovenian: Kakšne koristi zdravila Zinforo so se pokazale v študijah?
English: What are the risks associated with Zinforo?
Slovenian: Kakšna tveganja so povezana z zdravilom Zinforo?
English: Zinforo is an antibiotic.
Slovenian: Zdravilo Zinforo je antibiotik.
English: Zinforo (ceftaroline fosamil)
Slovenian: Zinforo (fosamilceftarolin)
English: As for all medicines, data on the use of Zinforo are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Zinforo stalno spremljajo.
English: Patients with complicated skin and soft tissue infections should be treated for 5 to 14 days and patients who have community-acquired pneumonia should be treated for 5 to 7 days.
Slovenian: Bolnike z zapletenimi okužbami kože in mehkih tkiv je treba zdraviti od pet do 14 dni, bolnike z zunajbolnišnično pljučnico pa od pet do sedem dni.
English: Side effects reported with Zinforo are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Zinforo, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Other information about Zinforo
Slovenian: Druge informacije o zdravilu Zinforo
English: In adults and adolescents from 12 years of age weighing at least 33 kg, the usual dose is 600 mg every 12 hours.
Slovenian: Običajni odmerek pri odraslih in mladostnikih, starejših od 12 let in s telesno maso vsaj 33 kg, je 600 mg vsakih 12 ur.
English: An overview of Zinforo and why it is authorised in the EU
Slovenian: Pregled zdravila Zinforo in zakaj je odobreno v EU
English: • complicated infections of the skin and soft tissue (tissue below the skin).
Slovenian: • zapletene okužbe kože in mehkih (podkožnih) tkiv.
English: For more information about using Zinforo, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Zinforo glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: This weakens the bacterial cell walls which then become prone to collapse, ultimately leading to the death of the bacteria.
Slovenian: To oslabi bakterijske celične stene, ki zato lažje propadejo, zaradi česar bakterije sčasoma odmrejo.
English: The most common side effects with Zinforo (seen in more than 3% of patients) are diarrhoea, headache, nausea (feeling sick) and pruritus (itching).
Slovenian: Najpogostejši neželeni učinki zdravila Zinforo (opaženi pri več kot 3 % bolnikov) so driska, glavobol, navzeja (slabost) in pruritus (srbenje).
English: It interferes with the production of complex molecules called peptidoglycans, which are essential components of bacterial cell walls.
Slovenian: Vpliva na tvorbo zapletenih molekul, imenovanih peptidoglikani, ki so temeljne sestavine celičnih sten bakterij.
English: In laboratory studies Zinforo was active against certain bacteria against which other antibiotics belonging to the beta-lactam class do not work (meticillin-resistant Staphylococcus aureus (MRSA) and penicillin non-susceptible Streptococcus pneumoniae (PNSP)).
Slovenian: V laboratorijskih študijah je bilo zdravilo Zinforo učinkovito zoper določene bakterije, proti katerim drugi antibiotiki iz skupine betalaktamov ne delujejo (na Staphylococcus aureus, odporno proti meticilinu (MRSA), in Streptococcus pneumoniae, neobčutljivo na penicilin (PNSP)).
English: It does so by blocking enzymes, called penicillin-binding protein transpeptidases, that are involved in the last steps of bacterial cell wall production.
Slovenian: V ta namen zavira encime, imenovane beljakovinske transpeptidaze, ki se vežejo na penicilin in so vključene v zadnje faze tvorbe celičnih sten bakterij.
English: Zinforo must also not be used in patients who are hypersensitive to other antibiotics belonging to the cephalosporin class and in patients who are severely allergic to other betalactam antibiotics.
Slovenian: Prav tako ga ne smejo uporabljati bolniki, ki so preobčutljivi za druge antibiotike iz skupine cefalosporinov, in bolniki, ki so hudo alergični na druge betalaktamske antibiotike.
English: The Agency also noted that in laboratory studies Zinforo had shown activity against certain bacteria, such as MRSA, against which other beta-lactam antibiotics do not work.
Slovenian: Prav tako je poudarila, da je bilo v laboratorijskih študijah ugotovljeno, da to zdravilo deluje zoper nekatere bakterije, kot je MRSA, na katere drugi antibiotiki iz skupine betalaktamov ne delujejo.
English: The active substance in Zinforo, ceftaroline fosamil, is a type of antibiotic called cephalosporin belonging to the group ‘beta-lactams'.
Slovenian: Učinkovina v zdravilu Zinforo, fosamilceftarolin, je vrsta antibiotika, ki se imenuje cefalosporin in spada v skupino betalaktamov.
English: The European Medicines Agency concluded that Zinforo was effective in treating complicated skin and soft tissue infections and community-acquired pneumonia and its side effects in both adults and children were manageable.
Slovenian: Evropska agencija za zdravila je ugotovila, da je bilo zdravilo Zinforo učinkovito pri zdravljenju zapletenih okužb kože in mehkih tkiv ter zunajbolnišnične pljučnice ter da so ga odrasli in otroci na splošno dobro prenašali.
English: Zinforo must not be used in people who are hypersensitive (allergic) to ceftaroline fosamil or any of the other ingredients.
Slovenian: Zdravila Zinforo ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) fosamilceftarolin ali katero koli drugo sestavino zdravila.
English: How is Zinforo used?
Slovenian: Kako se zdravilo Zinforo uporablja?
English: Among those with complicated community-acquired pneumonia, 90% of the patients treated with Zinforo were cured, compared with 100% of those receiving ceftriaxone plus vancomycin.
Slovenian: Med tistimi z zapleteno zunajbolnišnično pljučnico je bilo ozdravljenih 90 % bolnikov, ki so prejemali zdravilo Zinforo, v primerjavi s 100 % bolnikov, ki so prejemali ceftriakson in vankomicin.
English: Zinforo contains the active substance ceftaroline fosamil.
Slovenian: Zdravilo Zinforo vsebuje učinkovino fosamilceftarolin.
English: In a children's study of complicated skin and soft tissue infection, 94% of the children receiving Zinforo were cured (101 out of 107), compared with 87% of those receiving vancomycin or cefazolin, with or without aztreonam (45 out of 52).
Slovenian: V študiji z otroki z zapletenimi okužbami kože in mehkih tkiv je bilo ozdravljenih 94 % (101 od 107) bolnikov, ki so prejemali zdravilo Zinforo, v primerjavi s 87 % (45 od 52) bolnikov, ki so prejemali vankomicin ali cefazolin, uporabljenima s aztreonamom ali brez njega.