natgillin/translations-raw huggingface dataset:
Some side effects are more likely to occur in children than in adults, these include diarrhoea, pain following surgery, fever, vomiting, high blood pressure, itchy skin, infections of the nose and throat and infections in the urine. 
Nekateri neželeni učinki so bolj verjetni pri otrocih kot pri odraslih, ti vključujejo drisko, bolečino po operaciji, povišano telesno temperaturo, bruhanje, povišan krvni tlak, srbečo kožo, okužbe nosu in žrela, okužbe sečil.
The three year graft survival was not significantly different between placebo and daclizumab in the triple immunosuppressant trial (83% Vs. 84%) or the double immunosuppressant trial (78% Vs. 82%). 
Triletno preživetje presadka ni bilo statistično različno med placebom in daclizumabom v trojnem preskušanju imunosupresivov (83 % placebo, 84 % daclizumab) ali v dvojnem preskušanju imunosupresivov (78 % placebo, 82 % daclizumab).
Cytomegalovirus infection was reported in 16% of the patients in the placebo group and in 13% of the patients in the Zenapax group. 
Okužbe s citomegalovirusom so se pojavile pri 16 % bolnikov v placebo skupini in pri 13 % bolnikov v skupini, zdravljenih z Zenapaxom.
A MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IMETNIK(I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
Women of childbearing potential must use an effective contraceptive method during Zenapax therapy and continue its use for an additional 4 months following the last dose of Zenapax. 
Ženske v rodni dobi morajo med zdravljenjem z zdravilom Zenapax uporabljati učinkovito kontracepcijsko metodo in z njo nadaljevati še dodatne 4 mesece po prejemu zadnjega odmerka zdravila Zenapax.
Your doctor should advise you about using contraception before treatment with Zenapax is started, during treatment with Zenapax, and for an additional 4 months following the last dose of Zenapax. 
Zdravnik vam bo svetoval, da uporabljate kontracepcijo pred začetkom in med zdravljenjem z zdravilom Zenapax in še 4 mesece po zadnjem odmerku zdravila.
No gross changes to circulating lymphocyte numbers or cell phenotypes were observed by fluorescence-activated cell sorter (FACS) analysis other than the expected transient decrease in Tac+ cells. 
Z analizo FACS (s fluorescenco aktivirano celično razvrščevanje) niso opazili nobenih drugih očitnih sprememb v številu krožečih limfocitov ali celičnih fenotipih, kot pričakovano prehodno znižanje Tac+ celic.
You will receive 4 subsequent doses which are spaced 14 days apart from each other. 
Naslednje štiri odmerke boste prejeli v štirinajstdnevnih razmikih.
Do not use Zenapax - if you are allergic (hypersensitive) to daclizumab or to any of the other ingredients of Zenapax. 
Ne uporabljajte zdravila Zenapax - če ste alergični na (preobčutljivi za) daclizumab ali katerokoli drugo pomožno snov zdravila
Serious adverse events were reported by 44.4% of the patients in the placebo-treated group and 39.9% of the patients in the Zenapax-treated group. 
Resni neželeni učinki so se pojavili pri 44,4 % bolnikov, zdravljenih s placebom, in pri 39,9 % bolnikov, zdravljenih z Zenapaxom.
The volume of Zenapax containing the appropriate dose is added to 50 ml of sterile 0.9% saline solution and is administered intravenously over a 15 minute period. 
Volumen Zenapaxa, ki vsebuje ustrezen odmerek, dodamo k 50 ml sterilne 0,9-% raztopine natrijevega klorida in apliciramo intravensko v obdobju 15 minut.
Hyperglycaemia: No differences in abnormal haematologic or chemical laboratory test results were seen between placebo-treated and Zenapax-treated groups with the exception of fasting blood glucose. 
Hiperglikemija: med patološkimi hematološkimi ali kemičnimi laboratorijskimi testnimi rezultati ni bilo razlik med skupino, ki je jemala placebo in skupino, ki je jemala Zenapax, razen pri vrednostih krvnega sladkorja na tešče.
Instructions for use and handling 
Navodila za pripravo in ravnanje
Adverse events were reported by 95% of placebo and 96% of daclizumab treated patients. 
Neželeni učinki so se pojavili pri 95 % bolnikov, zdravljenih s placebom, in pri 96 % bolnikov, zdravljenih z daclizumabom.
Daclizumab*…………5 mg per 1 ml infusion 
daclizumab*…………..5 mg v 1 ml infuzije
Zenapax is used together with other immunosuppressive drugs, including cyclosporine and corticosteroids. 
Zenapax se uporablja skupaj z drugimi imunosupresivnimi zdravili, vključno s ciklosporinom in kortikosteroidi.
HOW TO USE ZENAPAX 
KAKO UPORABLJATI ZDRAVILO ZENAPAX
PHARMACEUTICAL FORM AND CONTENTS 1 vial of 5 ml 
FARMACEVTSKA OBLIKA IN VSEBINA 1 viala (5 ml)
There is no experience of the use of Zenapax in patients who are highly immunised. 
Za uporabo Zenapaxa pri visoko senzibiliziranih bolnikih ni izkušenj.
However due to potential harmful effects for the newborn, breast-feeding is contraindicated during the treatment and up to 4 months following the last dose of Zenapax. 
Zaradi možnega škodljivega učinka na novorojenčka je dojenje med zdravljenjem in 4 mesece po zadnjem odmerku zdravila Zenapax kontraindicirano.
QUALITATIVE AND QUANTITATIVE COMPOSITION Daclizumab*…………5 mg per 1 ml infusion 
KAKOVOSTNA IN KOLIČINSKA SESTAVA daclizumab*…………5 mg v 1 ml infuzije
The safety profile of Zenapax was studied in comparison to placebo in patients who concomitantly received immunosuppressive regimens containing cyclosporine and corticosteroids alone, with the addition of azathioprine or with the addition of mycophenolate mofetil. 
Varnostni profil Zenapaxa so primerjali s placebom pri bolnikih, ki so sočasno prejemali imunosupresivna zdravila, ki so vključevala ciklosporin in kortikosteroide same ali sočasno z azatioprinom ali mofetilmikofenolatom.
The following transplant medications have been administered in clinical trials with Zenapax without any interactions: cyclosporine, mycophenolate mofetil, gancyclovir, acyclovir, tacrolimus, azathioprine, antithymocyte immune globulin, muromonab-CD3 (OKT3), and corticosteroids. 
Pri kliničnih preskušanjih z Zenapaxom ni bilo medsebojnih delovanj z naslednjimi zdravili za transplantacijo: ciklosporinom, mofetilmikofenolatom, ganciklovirjem, aciklovirjem, takrolimusom, azatioprinom, antitimocitnim imunoglobulinom, muromonabom-CD3 (OKT3) in kortikosteroidi.
A dose of 1.5 mg/kg has been administered to bone marrow transplant recipients without any associated adverse events. 
Pri odmerku 1,5 mg/kg, ki je bil dan prejemnikom transplantata kostnega mozga, ni bilo nobenih škodljivih učinkov.
Zenapax should initially be given within 24 hours before transplantation. 
Prvi odmerek Zenapaxa moramo aplicirati 24 ur pred transplantacijo.
Incidence of malignancies: Three years after treatment, the incidence of malignancies was 7.8% in the placebo group compared with 6.4% in the Zenapax group. 
Incidenca malignih obolenj: tri leta po zdravljenju je bila incidenca malignih obolenj 7,8-% v placebo skupini in 6,4-% v skupini, zdravljeni z Zenapaxom.
In transplant recipients there is no experience of exposure to second or subsequent treatment courses using Zenapax. 
Pri prejemnikih presadkov do zdaj še ni izkušenj z dvakratnim ali večkratnim zdravljenjem z Zenapaxom.
Peak serum concentrations (peak + SD) rose between the first dose (16 + 12 µg/ml) and the fifth dose (21 + 14 µg/ml). 
Najvišje serumske koncentracije (vrh ± standardna deviacija) so naraščale med prvim (16 ± 12 µg/ml) in petim odmerkom (21 ± 14 µg/ml).
The mean ± standard deviation trough serum concentration prior to fifth dose was 7.6 ± 4.0 µg/ml. 
Srednja vrednost ± standardna deviacija najnižjih serumskih koncentracij pred petim odmerkom je bila 7,6 ± 4,0 µg/ml.
There is no evidence to indicate that Zenapax has an effect on your ability to drive a car or operate machinery. 
Vpliv na sposobnost upravljanja vozil in strojev Ni znano, da bi Zenapax vplival na sposobnost za vožnjo z avtom ali upravljanje s stroji.
METHOD OF ADMINISTRATION For intravenous use after dilution Read the package leaflet before use 
POSTOPEK UPORABE Za intravensko uporabo po razdredčitvi Pred uporabo preberite priloženo navodilo
Because Zenapax is an immunoglobulin, no metabolic drug-drug interactions are to be expected. 
Zenapax je imunoglobulin, zato ni pričakovati metaboličnih medsebojnih delovanj z drugimi zdravili.
One vial of 5 ml contains 25 mg of daclizumab* (5 mg/ml). 
Ena 5 ml viala vsebuje 25 mg daclizumaba* (5 mg/ml).
One vial with 5 ml concentrate for solution for infusion contains 25 mg daclizumab. 
Ena viala s 5 ml koncentrata za raztopino za infundiranje vsebuje 25 mg daclizumaba.
METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use, for infusion after dilution Read the package leaflet before use 
POSTOPEK IN POT(I) UPORABE ZDRAVILA Za intravensko uporabo, za infuzijo po razredčitvi Pred uporabo preberite priloženo navodilo
The clinical manifestations of these reactions include hypotension, tachycardia, hypoxia, dyspnoea, wheezing, laryngeal oedema, pulmonary oedema, flushing, diaphoresis, temperature increase, rash and pruritus. 
Klinični znaki teh reakcij so vključevali hipotenzijo, tahikardijo, hipoksijo, dispnejo, sopenje, edem grla, pljučni edem, rdečico, diaforezo, porast telesne temperature, izpuščaj in koprivnico.
Serious allergic reactions may occur following the administration of proteins. 
Beljakovine lahko povzročijo resne alergijske reakcije.
Store in a refrigerator (2 °C - 8 °C) Do not freeze 
Shranjujte v hladilniku (2 °C - 8 °C) Ne zamrzujte
The incidence of stillbirth, caesarean section and breech delivery were comparable between the control and treatment groups. 
Incidenca mrtvorojenosti, carskega reza in poroda z zadnjično vstavo je bila v kontrolni in zdravljeni skupini živali primerljiva.
The mean trough serum concentration before the fifth dose was 5.0 + 2.7 µg/ml. 
Pred petim odmerkom je bila srednja serumska koncentracija 5,0 ± 2,7 µg/ml.
MARKETING AUTHORISATION NUMBER(S) EU/1/99/098/001 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/99/098/001
Pharyngitis 
faringitis
- difficulty breathing - constipation; diarrhoea; vomiting; nausea; or heartburn - pain in joints and muscles - excess fluid in the body (oedema); swelling of the arms and legs (peripheral oedema) - problems with wound healing 
- oteženo dihanje, - zaprtje, driska, bruhanje, slabost ali zgaga, - bolečina v sklepih in mišicah, - nakopičenje tekočine v telesu (edem), otekanje rok in nog (periferni edem), - težave pri celjenju ran.
MARKETING AUTHORISATION NUMBER(S) EU/1/99/098/002 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/99/098/002
PHARMACEUTICAL FORM AND CONTENTS 3 vials of 5 ml each 
FARMACEVTSKA OBLIKA IN VSEBINA 3 viale (5 ml)
In rare cases severe hypersensitivity reactions following administration of Zenapax have been reported (see section 4.4). 
V redkih primerih so se po dajanju Zenapaxa pojavile resne preobčutljivostne reakcije (glejte poglavje
Concomitant use of Zenapax with another antilymphocyte antibody therapy in the context of intensive immunosuppression with cyclosporine, mycophenolate mofetil and corticosteroids may be a factor leading to fatal infection. 
Sočasna uporaba Zenapaxa z drugim zdravljenjem z antilimfocitnimi protitelesi lahko v smislu intenzivne imunosupresije s ciklosporinom, mofetilmikofenolatom in kortikosteroidi privede do smrtne okužbe.
Zenapax 5 mg/ml concentrate for solution for infusion is a clear, colourless to slightly yellowish liquid is supplied in vials containing 5 ml of solution. 
Zenapax 5 mg/ml koncentrat za raztopino za infundiranje je bistra, brezbarvna do rahlo rumenkasta tekočina.
Daclizumab was well tolerated after single bolus intravenous or subcutaneous doses ranging from 50 to 125 mg/kg in mice, rats, and rabbits and after 28 days administration of 15 mg/kg to monkeys. 
Po enkratnih intravenskih bolusih ali subkutanih odmerkih v obsegu od 50 do 125 mg/kg pri miših, podganah in kuncih in po 28-dnevnem dajanju 15 mg/kg pri opicah so ugotovili dobro prenašanje daclizumaba.
A total of 16% (10 of 64 patients) of placebo-treated and 32% (28 of 88 patients) of Zenapax-treated patients had high fasting blood glucose values. 
Visoke vrednosti krvnega sladkorja na tešče je imelo skupno 16 % bolnikov (10 od 64 bolnikov) v placebo skupini in 32 % (28 od 88 bolnikov) bolnikov, zdravljenih z Zenapaxom.
No data are available for patients with severe hepatic impairment. 
Za bolnike s hudo jetrno okvaro ni podatkov.
Zenapax is used to prevent your body from rejecting transplanted kidneys. 
Zenapax se uporablja za preprečevanje zavrnitve ledvičnega presadka.
In total you should receive 5 doses of Zenapax for a complete treatment course. 
Med celotnim zdravljenjem z Zenapaxom boste skupno prejeli pet odmerkov.
The twelve months mortality was 4.4% in the placebo- and 1.5% in the Zenapax-treated groups. 
Po dvanajstih mesecih je bilo v placebo skupini 4,4 % smrtnih primerov, v skupini, zdravljeni z Zenapaxom pa 1,5 %.
Injury and poisoning Common 
Poškodbe in zastrupitve pogosti posttravmatska bolečina
* Recombinant humanized IgG1 anti-Tac antibody produced in a murine NSO myeloma cell line using a glutamine synthetase (GS) expression system (NS_GSO) by recombinant DNA technology. 
* Rekombinantno humanizirano IgG1 anti-Tac protitelo, pridobljeno s tehnologijo rekombinantne DNA iz celične kulture mieloma NSO glodalcev s pomočjo ekspresijskega sistema glutamin sintetaze (NS_GSO, glutamin synthetase expression system).
There is no pharmacokinetic interaction between Zenapax and mycophenolic acid, the active metabolite of mycophenolate mofetil (CellCept). 
Med Zenapaxom in mikofenolno kislino, aktivnim presnovkom mofetilmikofenolata (CellCept®), ni farmakokinetičnih interakcij.
No dosage adjustment is necessary for patients with severe renal impairment. 
Za bolnike s hudo ledvično okvaro ni treba prilagajati odmerka.
Zenapax 5 mg/ml concentrate for solution for infusion Daclizumab 
Zenapax 5 mg/ml koncentrat za raztopino za infundiranje daclizumab
While Zenapax is an immunosuppressive drug, to date no increase in LPDs or opportunistic infections have been observed in patients treated with Zenapax. 
Od začetka uporabe Zenapaxa kot imunosupresivnega zdravila, pri bolnikih zdravljenih z Zenapaxom, niso opazili porasta LPD ali oportunističnih okužb.
Zenapax is a colourless solution provided as a single use vial. 
Zenapax je brezbarvna raztopina v vialah za enkratno uporabo.
Pharmacotherapeutic group: selective immunosuppressive agents ATC code: L04A A08 
Oznaka ATC: L04A A08.
Deaths occurring during the first 6 months post-transplant were reported in 3.4% of the placebo- and in 0.6% of the Zenapax-treated groups. 
Prvih šest mesecev po transplantaciji je bilo v placebo skupini 3,4 % smrtnih primerov, v skupini, zdravljeni z Zenapaxom pa 0,6 %.
Daclizumab is a humanised monoclonal antibody produced in a murine NSO myeloma cell line using a glutamine synthetase (GS) expression system (NS_GSO) by recombinant DNA technology. 
Daclizumab je humanizirano monoklonsko protitelo, pridobljeno s tehnologijo rekombinantne DNA iz celične kulture mieloma NSO glodalcev s pomočjo glutamin sintetaznega ekspresijskega sistema (NS_GSO).
Do not use Zenapax after the expiry date which is stated on the outer carton and on the vial label after the abbreviation EXP. 
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki na viali poleg oznake Uporabno do. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
- The other ingredients are polysorbate 80, sodium chloride, sodium dihydrogen phosphate, anhydrous, disodium phosphate anhydrous, hydrochloric acid concentrated, sodium hydroxide, water for injections. 
- Pomožne snovi so polisorbat 80, natrijev klorid, brezvodni natrijev dihidrogenfosfat, brezvodni natrijev hidrogenfosfat, koncentrirana klorovodikova kislina, natrijev hidroksid in voda za injekcije.
MARKETING AUTHORISATION NUMBER(S) EU/1/99/098/001 (single vial pack) EU/1/99/098/002 (3 vial pack) 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/99/098/001 (pakiranje z 1 vialo)
Polysorbate 80, sodium chloride, sodium dihydrogen phosphate anhydrous, disodium phosphate anhydrous, hydrochloric acid concentrated, sodium hydroxide, water for injection. 
SEZNAM POMOŽNIH SNOVI polisorbat 80, natrijev klorid, brezvodni natrijev dihidrogenfosfat, brezvodni natrijev hidrogenfosfat, koncentrirana klorovodikova kislina, natrijev hidroksid, voda za injekcije.
In a single randomized controlled clinical trial in cardiac transplant recipients which compared Zenapax to placebo, each used in combination with mycophenolate mofetil (CellCept 1.5 g bid), cyclosporine, and corticosteroids, there were more infection related deaths among patients who received Zenapax. 
V randomiziranem nadziranem kliničnem preskušanju so pri prejemnikih srčnega presadka primerjali Zenapax in placebo v kombinaciji z mofetilmikofenolatom (CellCept 1,5 g dvakrat na dan), ciklosporinom in kortikosteroidi.
NAME OF THE MEDICINAL PRODUCT Zenapax 5 mg/ml concentrate for solution for infusion 
IME ZDRAVILA Zenapax 5 mg/ml koncentrat za raztopino za infundiranje
What Zenapax contains 
Kaj vsebuje zdravilo Zenapax
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Zenapax 5 mg/ml concentrate for solution for infusion Daclizumab 
IME ZDRAVILA IN POT(I) UPORABE Zenapax 5 mg/ml koncentrat za pripravo raztopine za infundiranje daclizumab
It should be diluted in 50 ml of sterile 0.9% sodium chloride solution before administration to patients. 
Pred aplikacijo bolnikom ga je treba razredčiti v 50 ml sterilne 0,9-% raztopine natrijevega klorida.
However, of the 40 patients who received both Zenapax and antilymphocyte therapy, 8 (20.0%) died whereas of the 37 patients who received both placebo and antilymphocyte therapy, 2 (5.4%) died. 
Od 37 bolnikov, ki so prejemali placebo in antilimfocitno zdravljenje, sta umrla 2 (5,4 %).
Diabetes mellitus Fluid overload 
Infekcijske in parazitske bolezni pogosti rinitis sladkorna bolezen preobremenitev s tekočino
Very common Insomnia Depression 
Presnovne in prehranske motnje pogosti dehidracija zelo pogosti nespečnost depresija
HOW TO STORE ZENAPAX 
SHRANJEVANJE ZDRAVILA ZENAPAX
Very common Musculoskeletal pain Back pain 
Bolezni kože in podkožja pogosti hirzutizem zelo pogosti mišično-skeletna bolečina bolečina v hrbtu mišični krči artralgija
Lymphocele 
ZDRAVILA
Renal tubular necrosis Hydronephrosis Renal disorder (damage) Haemorrhage urinary tract Urinary retention Urinary tract disorder Oliguria 
Splošne težave in spremembe na mestu aplikacije pogosti mrazenje ledvična odpoved ledvična tubulna nekroza hidronefroza ledvična okvara krvavitev v sečilih zastoj urina bolezni sečil oligurija
Zenapax does not increase this risk when it is used together with other immunosuppressive drugs, including cyclosporine and corticosteroids. 
Zenapax pri uporabi z drugimi imunosupresivnimi zdravili, vključno s ciklosporinom in kortikosteroidi, tega tveganja ne poveča.
BEFORE YOU USE ZENAPAX 
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO ZENAPAX
Very common Hypertension(incl. 
Srčne bolezni pogosti tahikardija zelo pogosti hipertenzija (vključno s poslabšanjem) hipotenzija
Daclizumab binds to an antigen found on the surface of specific white blood cells called T lymphocytes. 
Daclizumab se veže na antigen, ki se nahaja na površini specifičnih belih krvnih celic, imenovanih limfociti T. Ta aktivnost zavre naravni imunski odziv telesa, ki bi sicer lahko povzročil zavrnitev presadka.
- Store in a refrigerator (2 °C - 8 °C). 
6.4 Posebna navodila za shranjevanje - Shranjujte v hladilniku (2 °C - 8 °C).
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription 
NAČIN IZDAJANJA ZDRAVILA Izdaja zdravila je le na recept
Sodium dihydrogen phosphate anhydrous Disodium phosphate anhydrous Hydrochloric acid, concentrated Sodium hydroxide 
limfokela pljučni edem plevralni izliv atelektaza hipoksija kongestija dihal pokanje kašelj
Zenapax is indicated for the prophylaxis of acute organ rejection in de novo allogenic renal transplantation and is to be used concomitantly with an immunosuppressive regimen, including cyclosporine and corticosteroids in patients who are not highly immunised. 
Uporablja se skupaj z imunosupresivnimi učinkovinami, vključno s ciklosporinom in kortikosteroidi pri bolnikih, ki niso visoko senzibilizirani.
The type of infections reported was similar in both the Zenapax- and the placebo-treated groups. 
Tipi okužb so bili podobni pri obeh skupinah bolnikov.
Pruritus Night sweats Hyperhidrosis 
Bolezni prebavil pogosti napenjanje kožni izpuščaj akne pruritus nočno potenje hiperhidroza
Nervous system disorders 
Bolezni živčevja pogosti parestezija
Strength Pharmaceutical Form 
IIzmišljeno) ime Jakost Farmacevtska oblika
MA EU Number (Invented) name 
(Izmišljeno) ime
Pharmaceutical form 
Farmacevtska oblika Pot uporabe Stična ovojnina Velikost pakiranja
These points were addressed together. 
Ti dve točki sta bili obravnavani skupaj.
This justification is based on the following arguments: 
Obrazložitev temelji na naslednjih argumentih:
The Member States concerned failed to reach an agreement regarding the product and consequently the matter was referred to the CVMP on 29 June 2012. 
Zadevne države članice niso uspele doseči dogovora v zvezi z zdravilom, zato je bila zadeva 29. junija 2012 predložena odboru CVMP.
The reference Member State (RMS) is the Netherlands and 12 concerned Member States (CMS) are involved: Austria, Belgium, Czech Republic, Denmark, France, Germany, Hungary, Ireland, Italy, Poland, Spain and the United Kingdom. 
Referenčna država članica je Nizozemska, zadevnih držav članic pa je 12: Avstrija, Belgija, Češka republika, Danska, Francija, Nemčija, Madžarska, Irska, Italija, Poljska, Španija in Združeno kraljestvo.
In conclusion, the applicant's arguments are not well set out. 
Argumenti predlagatelja prav tako niso ustrezno zastavljeni.
This was clear from the variability shown in the data and referred to by the applicant. 
To je razvidno iz variabilnosti, ki se kaže v podatkih in na katero se je skliceval predlagatelj.
Some differences in pharmacokinetic parameters are attributed to different size/age of animal. 
Nekatere razlike v farmakokinetičnih parametrih so posledica različne velikosti/starosti živali.
The applicant did not comment on the level of confidence that can be attained with the results of the residues study. 
Predlagatelj ni podal komentarja glede stopnje zaupanja, ki jo je mogoče doseči z rezultati študije ostankov.
Hence, the safety and efficacy of the product remains unknown for pigs. 
Zaradi tega varnost in učinkovitost zdravila za prašiče ostajata neznani.
Having considered all data submitted the CVMP concluded that: 
Po preučitvi vseh predloženih podatkov je CVMP prišel do naslednjih zaključkov:
However, the difference in concentration of the active substance also needs to be considered. 
Ne glede na to je treba upoštevati tudi razliko v koncentraciji zdravilne učinkovine.
Agreement was reached during the decentralised procedure with regard to data submitted to support the safety and the efficacy concerning target species cattle and horses. 
V decentraliziranem postopku je bil sprejet dogovor o podatkih, predloženih v podporo varnosti in učinkovitosti glede ciljnih vrst goveda in konjev.
An insufficient number of animals was used in each of the residues studies to achieve the required precision. 
Vseh obeh študijah ostankov je bilo uporabljeno nezadostno število živali, da bi lahko dosegli zahtevano natančnost.
I. Effect of comparing results from separately conducted studies The applicant has provided references that broadly show comparability of pharmacokinetic data derived in studies conducted at different times. 
I. Vpliv primerjave rezultatov ločeno izvedenih študij Predlagatelj je predložil reference, ki v grobem prikazujejo primerljivost farmakokinetičnih podatkov, izpeljanih iz študij, izvedenih ob različnih časih.
Scientific conclusions and grounds for refusal of the granting of the marketing authorisation 
Znanstveni zaključki in podlaga za zavrnitev vloge za izdajo dovoljenja za promet z zdravilom