FrancophonIA/ELRC3.0 huggingface dataset:
English: Polysorbate 80, sodium chloride, sodium dihydrogen phosphate anhydrous, disodium phosphate anhydrous, hydrochloric acid concentrated, sodium hydroxide, water for injection.
Slovenian: SEZNAM POMOŽNIH SNOVI polisorbat 80, natrijev klorid, brezvodni natrijev dihidrogenfosfat, brezvodni natrijev hidrogenfosfat, koncentrirana klorovodikova kislina, natrijev hidroksid, voda za injekcije.
English: 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.
Slovenian: 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.
English: NAME OF THE MEDICINAL PRODUCT Zenapax 5 mg/ml concentrate for solution for infusion
Slovenian: IME ZDRAVILA Zenapax 5 mg/ml koncentrat za raztopino za infundiranje
English: What Zenapax contains
Slovenian: Kaj vsebuje zdravilo Zenapax
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Zenapax 5 mg/ml concentrate for solution for infusion Daclizumab
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Zenapax 5 mg/ml koncentrat za pripravo raztopine za infundiranje daclizumab
English: It should be diluted in 50 ml of sterile 0.9% sodium chloride solution before administration to patients.
Slovenian: Pred aplikacijo bolnikom ga je treba razredčiti v 50 ml sterilne 0,9-% raztopine natrijevega klorida.
English: 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.
Slovenian: Od 37 bolnikov, ki so prejemali placebo in antilimfocitno zdravljenje, sta umrla 2 (5,4 %).
English: Diabetes mellitus Fluid overload
Slovenian: Infekcijske in parazitske bolezni pogosti rinitis sladkorna bolezen preobremenitev s tekočino
English: Very common Insomnia Depression
Slovenian: Presnovne in prehranske motnje pogosti dehidracija zelo pogosti nespečnost depresija
English: HOW TO STORE ZENAPAX
Slovenian: SHRANJEVANJE ZDRAVILA ZENAPAX
English: Very common Musculoskeletal pain Back pain
Slovenian: Bolezni kože in podkožja pogosti hirzutizem zelo pogosti mišično-skeletna bolečina bolečina v hrbtu mišični krči artralgija
English: Lymphocele
Slovenian: ZDRAVILA
English: Renal tubular necrosis Hydronephrosis Renal disorder (damage) Haemorrhage urinary tract Urinary retention Urinary tract disorder Oliguria
Slovenian: 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
English: Zenapax does not increase this risk when it is used together with other immunosuppressive drugs, including cyclosporine and corticosteroids.
Slovenian: Zenapax pri uporabi z drugimi imunosupresivnimi zdravili, vključno s ciklosporinom in kortikosteroidi, tega tveganja ne poveča.
English: BEFORE YOU USE ZENAPAX
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO ZENAPAX
English: Very common Hypertension(incl.
Slovenian: Srčne bolezni pogosti tahikardija zelo pogosti hipertenzija (vključno s poslabšanjem) hipotenzija
English: Daclizumab binds to an antigen found on the surface of specific white blood cells called T lymphocytes.
Slovenian: 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.
English: - Store in a refrigerator (2 °C - 8 °C).
Slovenian: 6.4 Posebna navodila za shranjevanje - Shranjujte v hladilniku (2 °C - 8 °C).
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription
Slovenian: NAČIN IZDAJANJA ZDRAVILA Izdaja zdravila je le na recept
English: Sodium dihydrogen phosphate anhydrous Disodium phosphate anhydrous Hydrochloric acid, concentrated Sodium hydroxide
Slovenian: limfokela pljučni edem plevralni izliv atelektaza hipoksija kongestija dihal pokanje kašelj
English: 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.
Slovenian: Uporablja se skupaj z imunosupresivnimi učinkovinami, vključno s ciklosporinom in kortikosteroidi pri bolnikih, ki niso visoko senzibilizirani.
English: The type of infections reported was similar in both the Zenapax- and the placebo-treated groups.
Slovenian: Tipi okužb so bili podobni pri obeh skupinah bolnikov.
English: Pruritus Night sweats Hyperhidrosis
Slovenian: Bolezni prebavil pogosti napenjanje kožni izpuščaj akne pruritus nočno potenje hiperhidroza
English: Nervous system disorders
Slovenian: Bolezni živčevja pogosti parestezija
English: Strength Pharmaceutical Form
Slovenian: IIzmišljeno) ime Jakost Farmacevtska oblika
English: MA EU Number (Invented) name
Slovenian: (Izmišljeno) ime
English: Pharmaceutical form
Slovenian: Farmacevtska oblika Pot uporabe Stična ovojnina Velikost pakiranja
English: These points were addressed together.
Slovenian: Ti dve točki sta bili obravnavani skupaj.
English: This justification is based on the following arguments:
Slovenian: Obrazložitev temelji na naslednjih argumentih:
English: 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.
Slovenian: Zadevne države članice niso uspele doseči dogovora v zvezi z zdravilom, zato je bila zadeva 29. junija 2012 predložena odboru CVMP.
English: 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.
Slovenian: 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.
English: In conclusion, the applicant's arguments are not well set out.
Slovenian: Argumenti predlagatelja prav tako niso ustrezno zastavljeni.
English: This was clear from the variability shown in the data and referred to by the applicant.
Slovenian: To je razvidno iz variabilnosti, ki se kaže v podatkih in na katero se je skliceval predlagatelj.
English: Some differences in pharmacokinetic parameters are attributed to different size/age of animal.
Slovenian: Nekatere razlike v farmakokinetičnih parametrih so posledica različne velikosti/starosti živali.
English: The applicant did not comment on the level of confidence that can be attained with the results of the residues study.
Slovenian: Predlagatelj ni podal komentarja glede stopnje zaupanja, ki jo je mogoče doseči z rezultati študije ostankov.
English: Hence, the safety and efficacy of the product remains unknown for pigs.
Slovenian: Zaradi tega varnost in učinkovitost zdravila za prašiče ostajata neznani.
English: Having considered all data submitted the CVMP concluded that:
Slovenian: Po preučitvi vseh predloženih podatkov je CVMP prišel do naslednjih zaključkov:
English: However, the difference in concentration of the active substance also needs to be considered.
Slovenian: Ne glede na to je treba upoštevati tudi razliko v koncentraciji zdravilne učinkovine.
English: 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.
Slovenian: V decentraliziranem postopku je bil sprejet dogovor o podatkih, predloženih v podporo varnosti in učinkovitosti glede ciljnih vrst goveda in konjev.
English: An insufficient number of animals was used in each of the residues studies to achieve the required precision.
Slovenian: Vseh obeh študijah ostankov je bilo uporabljeno nezadostno število živali, da bi lahko dosegli zahtevano natančnost.
English: 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.
Slovenian: 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.
English: Scientific conclusions and grounds for refusal of the granting of the marketing authorisation
Slovenian: Znanstveni zaključki in podlaga za zavrnitev vloge za izdajo dovoljenja za promet z zdravilom
English: The provided data are not sufficient to assure that study conditions have negligible influence on the data to the level required for this type of regulatory submission.
Slovenian: Na podlagi predloženih podatkov ni mogoče zaključiti, da imajo študijski pogoji zanemarljiv vpliv na podatke do ravni, zahtevane za to vrsto regulativne vloge.
English: Bioequivalence between the test product and the originator
Slovenian: Bioekvivalenca med testnim in originatorskim zdravilom
English: All references to the target species pigs should be removed from the final versions of the summary of product characteristics, labelling and package leaflet agreed during the Coordination group procedure.
Slovenian: Vse reference za ciljne vrste prašičev je treba odstraniti iz končne različice povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo, kot je bilo dogovorjeno v postopku koordinacijske skupine.
English: In order to do this, the applicant must establish a link between the test and reference products and as the product is systemically active, the assumptions behind the concept of bioequivalence would allow this.
Slovenian: Predlagatelj mora v ta namen vzpostaviti povezavo med testnimi in referenčnimi zdravili in ker je zdravilo sistemsko aktivno, predpostavke koncepta bioekvivalence to omogočajo.
English: List of the name, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, applicant in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravil za uporabo v veterinarski medicini, živalskih vrst, poti uporabe zdravila in predlagateljev v državah članicah
English: This is the standard that has been generally requested from applicants seeking to change the strength of an injectable formulation (other than for intravenous route).
Slovenian: To je standard, ki se ga na splošno zahteva od vseh predlagateljev, ki želijo spremeniti jakost pripravka za injiciranje (ki ni intravensko).
English: • Even if the formulations were inequivalent, the lack of bioequivalence would not be clinically relevant due to a wide therapeutic window.
Slovenian: • Tudi če formulaciji ne bi bili ekvivalentni, pomanjkanje bioekvivalence zaradi velike terapevtske širine ne bi bilo klinično relevantno.
English: The application was submitted as a generic hybrid application under Article 13(3), as there is currently no authorised product with the same concentration of meloxicam.
Slovenian: V skladu s členom 13(3) je bila vloga predložena za generično hibridno vlogo, ker dovoljenje za zdravilo z enako koncentracijo meloksikama trenutno ne obstaja.
English: 1 EMA CVMP Guideline on the conduct of bioequivalence studies for veterinary medicinal products (EMA/CVMP/016/00Rev.2) - http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/04/WC500105372.pdf
Slovenian: 1 Smernice CVMP EMA o izvajanju bioekvivalenčnih študij za zdravila za uporabo v veterinarski medicini (EMA/CVMP/016/00-Rev.2)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/04/WC500105372.pdf
English: Considering the data submitted, the Committee concluded as follows on issues raised in the notification received from the Netherlands.
Slovenian: Po preučitvi predloženih podatkov je Odbor glede vprašanj, ki jih je v sporočilu poslala Nizozemska, podal zaključke, ki so navedeni v nadaljevanju.
English: For horses and cattle the aqueous solution is administered via the intravenous route, therefore bioequivalence can be accepted as self-evident.
Slovenian: Pri konjih in govedu se vodna raztopina injicira intravensko, zato je mogoče bioekvivalenco sprejeti kot samoumevno.
English: The applicant considered it is not necessary to prove bioequivalence for this hybrid application but that a justification of therapeutic equivalence is sufficient.
Slovenian: Predlagatelj je izrazil mnenje, da bioekvivalence za to hibridno vlogo ni treba dokazati in da zadostuje obrazložitev terapevtske ekvivalence.
English: Reports from literature suggest that the rate of absorption of a substance may be increased with decreased injection volume and increased concentration.
Slovenian: Poročila iz literature navajajo, da se lahko z zmanjšanjem vbrizgane količine in povečano koncentracijo stopnja absorpcije učinkovine poveča.
English: The applicant accepted the timing and number of sampling points required for bioequivalence and residues depletion studies are very different, according to the respective guidelines.
Slovenian: Predlagatelj je sprejel časovno razporeditev in število vzorčenj, potrebnih za bioekvivalenco, študije izločanja ostankov pa so glede na zadevne smernice precej drugačne.
English: Czech republic CP-Pharma Handelsgesellschaft mbH Ostlandring 13
Slovenian: Češka republika CP-Pharma Handelsgesellschaft mbH Ostlandring 13
English: The test and reference products are qualitatively identical aqueous solutions, which differ only in the concentration of meloxicam and one of the excipients.
Slovenian: Testna in referenčna zdravila so kvalitativno identične vodne raztopine, ki se razlikujejo samo v koncentraciji meloksikama in ene od pomožnih snovi.
English: However, for regulatory approval of a generic/hybrid product where the purpose of the study is to show any formulation effects, it is expected that comparative pharmacokinetic data would be collected from a single study with controlled study conditions (e.g. sampling methods, analytical methods, homogenous animal group) to minimise the effect of other variables.
Slovenian: Ne glede na to je treba za regulativno potrditev generičnega/hibridnega zdravila, pri katerem je namen študije pokazati vsakršne vplive pripravka, zbrati primerljive farmakokinetične podatke ene študije z nadziranimi študijskimi pogoji (npr. metodami vzorčenja, analitičnimi metodami, homogeno skupino živali), da se zmanjša vpliv drugih spremenljivk.
English: Effect that the number of animals sampled has on the reliability of the results (taking into account that for a standard bioequivalence study the test: reference ratio of the pivotal parameters must fall within predefined statistical limits.)
Slovenian: Vpliv števila živali, na katerih je bilo izvedeno vzorčenje, na zanesljivost rezultatov (ob upoštevanju, da mora biti pri standardni bioekvivalenčni študiji razmerje med bistvenimi testnimi in referenčnimi parametri znotraj vnaprej določenih statističnih omejitev).
English: The Committee considered if the results from a residue depletion study may be used as a surrogate for data from a bioequivalence study.
Slovenian: Odbor je preučil, ali se lahko ugotovitve študije izločanja ostankov uporabijo kot nadomestek za podatke bioekvivalenčne študije.
English: • as this is a generic ‘hybrid' application, in the absence of other data the principles of bioequivalence would need to be applied to determine the expected safety and efficacy of the product by extrapolation of the pre-clinical and clinical data from the reference product.
Slovenian: • Ker gre za generično „hibridno“ vlogo, bi bilo treba zaradi pomanjkanja drugih podatkov s pomočjo načel bioekvivalence določiti pričakovano varnost in učinkovitost zdravila z ekstrapolacijo predkliničnih in kliničnih podatkov o referenčnem zdravilu.
English: In instances where it is not possible or scientifically relevant to conduct a blood-level bioequivalence/pharmacokinetic study, then alternative means (such as clinical end point studies) have to be used to demonstrate therapeutic equivalence.
Slovenian: V primerih, ko ni bilo mogoče ali znanstveno relevantno izvesti bioekvivalenčne/farmakokinetične študije na krvni ravni, so za prikaz terapevtske ekvivalence uporabljali alternativna sredstva (kot so klinične študije z opazovanimi dogodki).
English: While there is a theoretical risk of increased inflammation at the site of injection due to increased tonicity of the 40 mg/ml formulation compared with the lower concentration of the reference product, injection site clinical observations and gross and microscopic pathology conducted during the residues study indicated that local inflammatory responses were minimal.
Slovenian: Čeprav obstaja teoretično tveganje za povečanje vnetja na mestu injiciranja zaradi povečane toničnosti odmerka 40 mg/ml v primerjavi z manjšo koncentracijo referenčnega zdravila, klinična opazovanja mesta injiciranja ter skupne in mikroskopske patologije, izvedene med študijo ostankov, poročajo, da so bili lokalni vnetni odzivi minimalni.
English: The active substance is included in veterinary medicinal products currently authorised in the European Union via the centralised authorisation procedure, as well as nationally, for use in cattle, pigs, horses, dogs and cats.
Slovenian: Zdravilna učinkovina se uporablja v zdravilih za uporabo v veterinarski medicini, ki so trenutno odobrena v Evropski uniji s centraliziranim in nacionalnim postopkom za injiciranje pri govedu, prašičih, konjih, psih in mačkah.
English: Relevance of the results from a residue depletion study as a demonstration of bioequivalence
Slovenian: Relevantnost ugotovitev študije izločanja ostankov za prikaz bioekvivalence
English: In this instance, the principles of bioequivalence would need to be applied to enable extrapolation of the safety and efficacy data from the reference product.
Slovenian: V tem primeru bi morali za ekstrapolacijo podatkov o varnosti in učinkovitosti referenčnega zdravila uporabiti načela bioekvivalence.
English: However, in a bioequivalence study, the principle is that blood concentrations are determined over a certain timeframe, critically including the absorption phase, to derive an estimate of Cmax and AUC with the knowledge that these correlate with therapeutic effect.
Slovenian: Načelo bioekvivalenčne študije pa je, da se krvne koncentracije določijo v določenem časovnem okviru in kritično vključujejo fazo absorpcije, da se določi ocena vrednosti Cmax in AUC ob upoštevanju dejstva, da se ti dve vrednosti povezujeta s terapevtskih učinkom.
English: The tissue concentration levels were derived from samples taken at 4 hours and at 2, 4 and 8 days (20 mg/ml study) or 1, 3 and 5 days after the final administration (40 mg/ml study).
Slovenian: Stopnje koncentracij v tkivih so bile izpeljane iz vzorcev, pridobljenih po 4 urah in po 2, 4 in 8 dneh (študija odmerka 20 mg/ml) ali 1, 3 in 5 dni po zadnje injiciranju (študija odmerka 40 mg/ml).
English: However, for pigs, where the product is administered intramuscularly, the applicant has not provided sufficient evidence of the relative rate and extent of absorption, to allow extrapolation of the data from the reference product.
Slovenian: Vendar pri prašičih, pri katerih se zdravilo injicira intramuskularno, predlagatelj ni zagotovil zadostnih dokazov o relativni hitrosti in obsegu absorpcije, ki bi omogočali ekstrapolacijo podatkov o referenčnem zdravilu.
English: Timing and number of sampling points and how this relates to characterisation of the rate and extent of absorption and IV. Meloxicam concentrations in the tissues sampled (liver, kidney, muscle and injection site) and their relation to plasma pharmacokinetics.
Slovenian: Časovna razporeditev in število vzorčenj ter kako se povezujejo z opisom značilnosti stopnje in obsega absorpcije in IV. Koncentracije meloksikama v vzorčnem tkivu (jetrih, ledvicah, mišicah in mestu injiciranja) in njihova povezava s plazemsko farmakokinetiko.
English: Grounds for the refusal of the granting of marketing authorisations for the target species pigs
Slovenian: Podlaga za zavrnitev dovoljenja za promet z zdravilom za ciljne vrste prašičev
English: The main remaining risk arises from the uncertainty due to lack of data on the pharmacokinetic profile and exposure to meloxicam following intramuscular injection of the 40 mg/ml test product in pigs.
Slovenian: Glavno preostalo tveganje je posledica negotovosti, ki izhaja iz pomanjkanja podatkov o farmakokinetičnem profilu in izpostavljenosti meloksikamu po intramuskularnem injiciranju 40 mg/ml testnega zdravila pri prašičih.
English: It also has anti-endotoxic properties which inhibit production of thromboxane B2 induced by E. coli endotoxin administration in calves, lactating cows and pigs.
Slovenian: Deluje tudi antiendotoksično, saj zavira nastajanje tromboksana B2, izzvano z vnosom endotoksina E. coli pri govedu, kravah v obdobju laktacije in prašičih.
English: Overall summary of the scientific evaluation of Melosolute 40 mg/ml solution for injection
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Melosolute 40 mg/ml raztopina za injiciranje
English: In the CVMP list of questions, the applicant was requested to address (i) the effect of comparing results from separately conducted studies, (ii) the effect that the number of animals sampled has on the reliability of the results (taking into account that for a standard bioequivalence study the test/reference ratio of the pivotal parameters must fall within predefined statistical limits); (iii) the timing and number of sampling points and how this relates to characterisation of the rate and extent of absorption; and (iv) how meloxicam concentrations in the tissues sampled (liver, kidney, muscle and injection site) relate to plasma pharmacokinetics.
Slovenian: Na seznamu vprašanj je CVMP od predlagatelja zahteval, da navede (i) vpliv primerjave rezultatov ločeno izvedenih študij, (ii) vpliv števila živali, na katerih je bilo izvedeno vzorčenje, na zanesljivost rezultatov (ob upoštevanju, da mora biti pri standardni bioekvivalenčni študiji razmerje med bistvenimi testnimi in referenčnimi parametri znotraj vnaprej določenih statističnih omejitev), (iii) časovno razporeditev in število vzorčenj ter kako se povezujejo z opisom značilnosti stopnje in obsega absorpcije in (iv) kako se koncentracije meloksikama v vzorčnem tkivu (jetrih, ledvicah, mišicah in mestu injiciranja) povezujejo s plazemsko farmakokinetiko.
English: However, the applicant claims there is a very fast distribution of meloxicam from the intramuscular injection site into the general circulation and subsequently a very fast elimination from tissues like liver, kidney and muscle taking into consideration the identical elimination half-life in pigs after intravenous or intramuscular administration, which justifies the claim for waiver of a bioequivalence study in pigs based on results of the residue depletion study in comparison to the Metacam 20 mg/ml product.
Slovenian: Vendar predlagatelj trdi, da je porazdelitev meloksikama z mesta intramuskularnega injiciranja v splošni obtok zelo hitra, kar posledično pomeni zelo hitro izločanje iz tkiv, kot so jetra, ledvice in mišice, če upoštevamo identično razpolovno dobo izločanja pri prašičih po intravenskem ali intramuskularnem injiciranju, ki upravičuje zahtevek za oprostitev bioekvivalenčnih študij pri prašičih na osnovi rezultatov študije izločanja ostankov v primerjavi z zdravilom Metacam 20 mg/ml.
English: The CVMP does not accept that the comparison of residues from two different products at a single time point allows conclusions to be drawn about the blood concentration-time profile, or that the studies provide an accurate estimate of relative bioavailability.
Slovenian: CVMP meni, da enkratna primerjava ostankov dveh različnih zdravil ne omogoča sklepanja o časovnem profilu krvne koncentracije in da študije ne omogočajo točne ocene relativne biološke uporabnosti.