natgillin/translations-raw huggingface dataset:
Coadministration of multiple 600 mg doses of rifampin with a single 125 mg palbociclib dose decreased palbociclib AUCinf and Cmax by 85% and 70%, respectively, relative to a single 125 mg palbociclib dose given alone. 
Sočasna uporaba večkratnih odmerkov 600 mg rifampicina skupaj z enkratnim odmerkom 125 mg palbocikliba je zmanjšala AUCinf in cmax palbocikliba za 85 % oziroma 70 % v primerjavi s samostojno uporabo enkratnega odmerka 125 mg palbocikliba.
IBRANCE 100 mg hard capsules Each hard capsule contains 100 mg of palbociclib. 
IBRANCE 100 mg trde kapsule Ena trda kapsula vsebuje 100 mg palbocikliba.
Talk to your doctor, pharmacist or nurse before taking IBRANCE. 
Pred začetkom jemanja zdravila IBRANCE se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
IBRANCE 125 mg hard capsules Each hard capsule contains 125 mg of palbociclib. 
IBRANCE 125 mg trde kapsule Ena trda kapsula vsebuje 125 mg palbocikliba.
IBRANCE 75 mg hard capsules Each hard capsule contains 75 mg of palbociclib. 
IBRANCE 75 mg trde kapsule Ena trda kapsula vsebuje 75 mg palbocikliba.
Under fasting conditions, the coadministration of multiple doses of the proton pump inhibitor (PPI) rabeprazole with a single dose of 125 mg IBRANCE decreased palbociclib AUCinf and Cmax by 62% and 80%, respectively. 
Na tešče je sočasna uporaba večkratnih odmerkov PPI, rabeprazola, skupaj z enkratnim odmerkom 125 mg zdravila IBRANCE zmanjšala AUCinf in cmax palbocikliba za 62 % oziroma 80 %.
- IBRANCE 125 mg is supplied as opaque, hard capsules, with a caramel body (printed “PBC 125” in white) and a caramel cap (printed “Pfizer” in white). 
Zdravilo IBRANCE 125 mg je na voljo v obliki neprozornih, trdih kapsul s karamelnim telesom (z belo natisnjeno oznako “PBC 125”) in karamelnim pokrovčkom (z belo natisnjeno oznako “Pfizer”).
Opaque, hard capsule, with a light orange body (printed “PBC 75” in white) and a light orange cap (printed “Pfizer” in white). 
Neprozorna, trda kapsula s svetlo oranžnim telesom (z belo natisnjeno oznako “PBC 75”) in svetlo oranžnim pokrovčkom (z belo natisnjeno oznako “Pfizer”).
IBRANCE plus letrozole (N=214) 
Zdravilo IBRANCE in letrozol (n = 214)
Hazard ratio [(95% CI) and p-value] 
razmerje ogroženosti [(95 % IZ) in vrednost p]
No dose adjustments are required for coadministration of palbociclib with moderate CYP3A inducers (see section 4.5). 
Pri sočasni uporabi palbocikliba z zmernimi induktorji CYP3A prilagajanje odmerka ni potrebno (glejte poglavje 4.5).
f Thrombocytopenia includes the following PTs: Thrombocytopenia, Platelet count decreased. 
f. Trombocitopenija vključuje naslednje PT: trombocitopenija, zmanjšanje števila trombocitov.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL - 100 MG CAPSULES 
NALEPKA NA PLASTENKI - 100 MG KAPSULE
- IBRANCE 100 mg is supplied as opaque, hard capsules, with a light orange body (printed “PBC 100” in white) and a caramel cap (printed “Pfizer” in white). 
Zdravilo IBRANCE 100 mg je na voljo v obliki neprozornih, trdih kapsul s svetlo oranžnim telesom (z belo natisnjeno oznako “PBC 100”) in karamelnim pokrovčkom (z belo natisnjeno oznako “Pfizer”).
How to store IBRANCE 
Shranjevanje zdravila IBRANCE
Opaque, hard capsule, with a caramel body (printed “PBC 125” in white) and a caramel cap (printed “Pfizer” in white). 
Neprozorna, trda kapsula s karamelnim telesom (z belo natisnjeno oznako “PBC 125”) in karamelnim pokrovčkom (z belo natisnjeno oznako “Pfizer”).
OR [%, (95% CI)] TTR, Median [months (range)] 
TTR, mediana [meseci (razpon)]
The dose may be lowered to one of the other available strengths 100 mg or 75 mg. Take IBRANCE once a day at about the same time every day with food, preferably a meal. 
Zdravilo IBRANCE vzemite enkrat na dan, vsak dan ob približno istem času, skupaj s hrano, priporočljivo z obrokom.
Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia. 
Pri bolnikih, pri katerih se razvije nevtropenija stopnje 3 ali 4, je priporočljiva prekinitev odmerjanja,
NAME OF THE MEDICINAL PRODUCT IBRANCE 100 mg hard capsules palbociclib 
IBRANCE 100 mg trde kapsule palbociklib
Discuss contraception with your doctor if there is any possibility that you or your partner may become pregnant. 
Če obstaja možnost, da lahko zanosite ali lahko zanosi vaša partnerka, se posvetujte z zdravnikom glede kontracepcije.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 125 MG CAPSULES 
NALEPKA NA PLASTENKI - 125 MG KAPSULE
Opaque, hard capsule, with a light orange body (printed “PBC 100” in white) and a caramel cap (printed “Pfizer” in white). 
Neprozorna, trda kapsula s svetlo oranžnim telesom (z belo natisnjeno oznako “PBC 100”) in karamelnim pokrovčkom (z belo natisnjeno oznako “Pfizer”).
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL - 75 MG CAPSULES 
NALEPKA NA PLASTENKI - 75 MG KAPSULE
NAME OF THE MEDICINAL PRODUCT IBRANCE 125 mg hard capsules palbociclib 
IBRANCE 125 mg trde kapsule palbociklib
Appropriate monitoring should be performed (see sections 4.2 and 4.8). 
zmanjšanje odmerka ali odložitev začetka ciklov zdravljenja, bolnike pa je treba ustrezno spremljati (glejte poglavji 4.2 in 4.8).
Palbociclib did not prolong the QTc to any clinically relevant extent at the recommended dose of 125 mg daily (Schedule 3/1). 
Ob priporočenem odmerku 125 mg na dan (shema 3/1) palbociklib ni podaljšal intervala QTc v klinično pomembnem obsegu.
The majority of the material was excreted as metabolites. 
Učinkovina se je večinoma izločila v obliki presnovkov.
In particular, the following may increase the risk of side effects with IBRANCE: 
Tveganje za pojav neželenih učinkov zdravila IBRANCE lahko še zlasti povečajo naslednja zdravila:
NAME OF THE MEDICINAL PRODUCT IBRANCE 75 mg hard capsules palbociclib 
IBRANCE 75 mg trde kapsule palbociklib
- use of preparations containing St. John's Wort should be avoided while you are taking IBRANCE. 
-v času jemanja zdravila IBRANCE ne jemljite pripravkov, ki vsebujejo šentjanževko.
Dry skin General disorders and administration site conditions 
Bolezni kože in podkožja zelo pogosti izpuščaj alopecija
• chest pain 
• bolečina v prsnem košu.
You should avoid becoming pregnant while taking IBRANCE. 
Med jemanjem zdravila IBRANCE se izogibajte zanositvi.
Palbociclib is a weak, time-dependent inhibitor of CYP3A following daily 125 mg dosing at steady state. 
Po dnevnem odmerjanju 125 mg je palbociklib v stanju dinamičnega ravnovesja šibek, časovnoodvisen zaviralec CYP3A.
* Adverse Drug Reaction (ADR) identified post-marketing. 
Neželeni učinek, ugotovljen v obdobju trženja zdravila.
Patients were well matched for baseline demographics and prognostic characteristics between the palbociclib plus letrozole arm and the placebo plus letrozole arm. 
Bolnice skupine s palbociklibom in letrozolom in skupine s placebom in letrozolom so bile precej enakovredne glede izhodiščnih demografskih podatkov in prognostičnih značilnosti.
EU/1/16/1147/007 (63 hard capsules) 
EU/1/16/1147/001 (21 trdih kapsul) EU/1/16/1147/007 (63 trdih kapsul)
Patients were well matched for baseline demographics and prognostic characteristics between the palbociclib plus fulvestrant arm and the placebo plus fulvestrant arm. 
Bolnice skupine s palbociklibom in fulvestrantom in skupine s placebom in fulvestrantom so bile precej enakovredne glede izhodiščnih demografskih podatkov in prognostičnih značilnosti.
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 125 mg palbociclib. 
Ena kapsula vsebuje 125 mg palbocikliba.
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 100 mg palbociclib. 
Ena kapsula vsebuje 100 mg palbocikliba.
Decreased appetite Nervous system disorders 
Bolezni prebavil zelo pogosti stomatitis navzea diareja bruhanje
Netherlands, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Norway, Poland, Portugal and Spain. 
Nizozemska, Avstrija, Belgija, Danska, Finska, Francija, Nemčija, Grčija, Madžarska, Irska, Italija, Luksemburg, Norveška, Poljska, Portugalska in Španija.
The indication proposed cannot be accepted. 
Predlagane indikacije ni mogoče sprejeti.
The youngest horse included in the field trial was 16 months old. 
Najmlajši konj, ki je bil vključen v terensko raziskavo, je bil star 16 mesecev.
Product invented name 
Izmišljeno ime izdelka
The test procedure did not follow the methods for a controlled or critical test. 
Postopek testiranja ni upošteval metod za kontrolirano ali kritično raziskavo.
Retreatment should be done according to the epidemiological situation, but not at less than 30 days interval 
Ponovno zdravljenje se naj izvaja v skladu z epidemiološko situacijo, vendar ne v intervalu, ki je krajši od 30 dni.
Efficacy should have been investigated at the lowest dose recommended. 
Učinkovitost bi morala biti preučena pri najmanjšem priporočenem odmerku.
Thus the proposal from the MAH, although scientifically justified, remains practically very questionable. 
Zato ostaja predlog imetnika dovoljenja za promet, čeprav je znanstveno utemeljen, v praksi dejansko zelo vprašljiv.
The wording of the proposal for Section 4.2 of the SPC is not supported. 
Predlagano besedilo poglavja 4.2 SPC ni utemeljeno.
Frequency and route of administration 
Pogostost in način uporabe
Based on the critical test performed, the efficacy against Parascaris was 100%. 
Na podlagi opravljene kritične raziskave je bila učinkovitost proti rodu Parascaris 100 %.
The WAAVP guidelines state that, for a field trial, data from at least 100 horses should be obtained in each of 3 different areas. 
Smernice združenja WAAVP navajajo, da je treba pri terenskih raziskavah zbrati podatke za najmanj 100 konj za vsako od 3 različnih področij.
A single field study was submitted in support of the efficacy of the product. 
Predložena je bila ena terenska raziskava, ki je utemeljevala učinkovitost izdelka.
The relative egg reductions calculations do not reflect these findings, particularly regarding P. equorum. 
Izračuni relativnega zmanjšanja števila jajčec ne odražajo teh izsledkov, še zlasti ne pri vrsti P. equorum.
The results for efficacy of Eqvalan measured this way were also below 90%. 
Tudi rezultati učinkovitosti zdravila Eqvalan, ki so bili izmerjeni na ta način, so bili pod 90 %.
ANNEX III CONDITION FOR THE LIFTING OF THE SUSPENSION 
DODATEK III POGOJ ZA PREKLIC UMIKA
Recommended dose 
Priporočen odmerek
- This was not a multicentric trial. 
- Nobena raziskava ni bila multicentrična.
This has not been shown, and in fact the indication is so restricted that the product could not be used for routine deworming in the horse. 
To ni bilo dokazano, pa tudi dejansko je indikacija tako omejena, da izdelka ne bi bilo mogoče uporabljati za rutinsko zatiranje notranjih zajedavcev pri konjih.
Parascaris equorum should have been selected as the dose limiting parasite. 
Vrsto Parascaris equorum bi morali izbrati kot zajedavca, ki omejujejo odmerek.
- The mean dose of test product administered was consistently and significantly more (40%, 0.278mg/kg) than the recommended treatment dose. 
- Povprečen odmerek testnega izdelka je bil stalno in značilno večji (40 %, 0,278 mg/kg) od priporočenega odmerka za zdravljenje.
Therefore the relevance of the bibliographical data regarding Eqvalan to the test product cannot be confirmed. 
Zato ustreznosti bibliografskih podatkov o zdravilu Eqvalan za testni izdelek ni mogoče potrditi.
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. 
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.
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: 
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:
For Parascaris type eggs, the results were 50% by day 3 and 65.2% by day 8. 
Za jajčeca rodu Parascaris je bilo 3. dne zmanjšanje 50 %, 8. dan pa 65,2 %.
ANNEX I NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER 
DODATEK I IME, FARMACEVTSKA OBLIKA, JAKOST ZDRAVILA, ŽIVALSKE VRSTE, NAČINI UPORABE IN IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
CONDITION FOR THE LIFTING OF THE SUSPENSION 
POGOJ ZA PREKLICA UMIKA
For dose confirmation studies, ‘at least two controlled or, where appropriate, critical dose confirmation studies ….. are recommended.' 
Za raziskave za določitev odmerka velja, da »sta priporočljivi vsaj dve kontrolirani ali, kjer ustreza, kritični raziskavi za določitev odmerka«.
The number of horses with an adequate infection pretreatment is impossible to determine as no negative control group was included. 
Nemogoče je določiti število konjev z ustreznim predhodnim zdravljenjem okužb, saj raziskava ni vsebovala negativne kontrolne skupine.
- Although non-inferiority was demonstrated to Eqvalan, this is not a recognised measure of efficacy of a new product. 
- Čeprav je bila dokazana enakovrednost zdravilu Eqvalan, to ni priznano merilo učinkovitosti novega izdelka.
Therefore, this product would not be considered interchangable with other ivermectin containing products already on the market. 
Posledično tega izdelka ne bi bilo mogoče obravnavati kot medsebojno zamenljivega z drugimi izdelki, ki vsebujejo ivermektin in so že na trgu.
The current application cannot be considered satisfactory as there is no scientific basis on which to grant an authorisation with the proposed SPC. 
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).
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. 
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.
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. 
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 %.
Based on the following, interchangeability with other ivermectin containing products cannot be accepted: 
Na podlagi naslednjega ni mogoče sprejeti medsebojne zamenljivosti z drugimi izdelki, ki vsebujejo ivermektin:
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. 
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.
Even the amended indication for the treatment of gastrointestinal endoparasitic infections in horses has not been demonstrated by the data provided. 
Tudi spremenjene indikacije za zdravljenje gastrointestinalnih endoparazitskih okužb pri konjih predloženi podatki ne dokazujejo.
Without necropsy or a large sample size, it is impossible to draw any meaningful conclusions from this study regarding the efficacy of Equimectin. 
Brez nekropsije ali velikega vzorca ni mogoče priti do merodajnih zaključkov iz te raziskave glede učinkovitosti zdravila Equimectin.
- The dose-limiting parasite had not been specified or selected. 
- Zajedavci, ki omejujejo uporabo odmerka, niso bili določeni ali izbrani.
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. 
Relativno zmanjšanje števila jajčec rodu Strongylus v gramu iztrebkov za testni izdelek je bilo 3. dan 88,2 % in 8. dan 88,2 %.
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.' 
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«.
A single administration of 0.2 mg ivermectin per kg of bodyweight. 
En odmerek 0,2 mg ivermektina na kg telesne mase.
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. 
Odbor je po presoji zadeve sklenil, da na osnovi razpoložljivih podatkov o zdravilu Equimectin bioekvivalenca z referenčnim izdelkom ni bila dokazana.
- The number of horses recruited was too low to produce meaningful results. 
- Število preučevanih konj je bilo prenizko, da bi bili rezultati merodajni.
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. 
Posledično obstaja v primeru, ko se zdravilo daje ob upoštevanju priporočenega odmerka, možnost neobstoja učinkovitosti ter potencial za razvoj odpornosti na antihelmintike.
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. 
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.
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. 
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.
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. 
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.
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. 
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.
- The principle criteria used for a comparison of effect is egg count reduction/larval identification or parasite counts in dose confirmation studies. 
- Načelni kriterij, uporabljen za primerjavo učinka, je zmanjšanje števila jajčec/identifikacija ličink ali število zajedavcev v raziskavah za določitev odmerka.
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. 
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.
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. 
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.
There is no reference in the Marketing Authorisation Holder's responses to the study that generated the results tables. 
V odgovorih imetnika dovoljenja za promet ni sklicevanja na raziskavo, iz katere izhajajo tabele z rezultati.
- 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. 
- 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.
The dose of Eqvalan was found to be 10% higher in the field trial than indicated. 
Odmerek zdravila Eqvalan pri terenski raziskavi je bil 10 % večji od navedenega.
No data were provided concerning the efficacy against ectoparasites. 
Podatki o učinkovitosti proti ektoparazitom niso bili predloženi.
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. 
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.
- 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. 
- Iz tabel, ki so vključene v dokumentaciji odgovora, ni razvidno, za katere zajedavce veljajo, prav tako ni razdelitve po vrstah zajedavcev.
The results were not divided for each parasite species. 
Rezultati niso bili razdeljeni glede na vrste zajedavcev.