FrancophonIA/ELRC3.0 huggingface dataset:
English: • Based on data generated in the pivotal pharmacokinetic study, intramuscular administration of the proposed recommended treatment dose resulted in mean peak serum concentrations of ~9 - 10 μg/ml by approximately 1 hour after treatment.
Slovenian: • Na podlagi podatkov, pridobljenih v osrednji farmakokinetični študiji, je intramuskularno dajanje predlaganega priporočenega terapevtskega odmerka povzročilo najvišje koncentracije v serumu ~9-10 μg/ml približno 1 uro po zdravljenju.
English: A florfenicol concentration of 4 x MIC (2 μg/ml) resulted in a decrease of bacterial count by 99.9% (3-Log drop) in 4 - 8 hours for the M. haemolytica isolates.
Slovenian: Koncentracija florfenikola 4 x MIK (2 μg/ml) je v 4-8 urah povzročila zmanjšanje števila bakterij za 99,9 % (upad 3-log) za izolate M. haemolytica.
English: Grounds for amendment of the summary of product characteristics
Slovenian: Razlogi za spremembo povzetka glavnih značilnosti zdravila
English: The results of this study demonstrated that florfenicol administered once daily at a dose of either 10, 20 or 30 mg/kg was effective for the treatment of pneumonia in sheep induced by M. haemolytica.
Slovenian: Rezultati te študije so pokazali, da je bil florfenikol, uporabljen enkrat dnevno v odmerku 10, 20 ali 30 mg/kg, učinkovit za zdravljenje pljučnice pri ovcah, ki jo je povzročila M. haemolytica.
English: These issues remained unsolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the CMD(v) was started.
Slovenian: Zadeva je ostala nerešena, zato je bila v skladu s členom 33(1) Direktive 2001/82/ES napotena k Usklajevalni skupini za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v veterinarski medicine (CMD(v)).
English: Similarly, a florfenicol concentration of 2 x MIC (0.5-1 μg/ml) resulted in a 3-Log drop of bacterial count in 10 - 24 hours for the P. multocida isolates.
Slovenian: Podobno so koncentracije florfenikola 2 x MIK (0,5-1 μg/ml) v 10-24 urah povzročile upad 3-log števila bakterij za izolate P. multocida.
English: Overall summary of the scientific evaluation of Nuflor 300 mg/ml solution for injection for cattle and sheep
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Nuflor 300 mg/ml raztopina za injiciranje za govedo in ovce
English: • The proposed dosing schedule is supported by a dose finding study using an experimental model of respiratory disease where test animals were challenged with Mannheimia haemolytica, and
Slovenian: • da predlagani režim odmerjanja podpirajo izsledki študije za določitev odmerka z uporabo poskusnega modela bolezni dihal, v katerem so testne živali okužili z Mannheimia haemolytica in
English: Therefore, the CVMP concluded that the objections raised by Denmark should not prevent the granting of the marketing authorisation for Nuflor 300 mg/ml solution for injection for cattle and sheep as the overall benefit-risk balance of the product is positive, subject to the recommended changes in the product information set out in annex III.
Slovenian: Zato je odbor CVMP zaključil, da ugovori Danske ne preprečijo izdaje dovoljenja za promet z zdravilom Nuflor 300 mg/ml raztopina za injiciranje za govedo in ovce, saj je splošno razmerje med tveganji in koristmi za to zdravilo pozitivno pod pogojem, da se v informacije o zdravilu navedene v Prilogi III, vnesejo priporočene spremembe.
English: Based on the findings of the field study, the applicant concluded that based on the primary efficacy parameter - treatment failure rates, Nuflor can be considered superior (at Day 4) or non-inferior (at Day 11) to the positive control product containing 100 mg/ml oxytetracycline, when used for the treatment of respiratory disease in sheep associated with either M. haemolytica or P. multocida.
Slovenian: Na podlagi izsledkov iz študije na terenu je predlagatelj sklenil, da se lahko na podlagi primarnega parametra učinkovitosti - deleža neuspešnosti zdravljenja - zdravilo Nuflor obravnava kot bolj (na 4. dan) ali enako učinkovito (na 11. dan) kot zdravilo s pozitivno kontrolo, ki vsebuje 100 mg/ml oksitetraciklina, če se uporablja za zdravljenje bolezni dihal pri ovcah, povezanih z M. haemolytica ali P. multocida.
English: Nuflor 300 mg/ml solution for injection for cattle and sheep contains florfenicol as active substance.
Slovenian: Zdravilo Nuflor 300 mg/ml raztopina za injiciranje za govedo in ovce vsebuje zdravilno učinkovino florfenikol.
English: • A field study conducted in line with EMA/CVMP guideline recommendations showed that Nuflor, administered in accordance with the proposed dosing schedule, was non-inferior to the authorised reference product, Terramycin 100 mg/ml, when used for the treatment of respiratory disease in sheep associated with either Mannheimia haemolytica or Pasteurella multocida.
Slovenian: • da je študija na terenu, opravljena po priporočilih smernice EMA/CVMP, pokazala, da zdravilo Nuflor, če se uporablja v skladu s predlaganim režimom odmerjanja, ni slabše kot odobreno referenčno zdravilo, Terramycin 100 mg/ml, kar zadeva zdravljenje bolezni dihal pri ovcah, povezanih z Mannheimia haemolytica ali Pasteurella multocida.
English: However, the CVMP agreed that section 4.9 of the Summary of Product Characteristics should be amended to clarify that the recommended treatment dose and treatment interval for sheep is based on the time mean florfenicol concentrations are maintained above MIC90 (see Annex III).
Slovenian: Vendar pa se je odbor CVMP strinjal, da je treba poglavje 4.9 povzetka glavnih značilnosti zdravila ustrezno spremeniti z vključitvijo pojasnila, da priporočeni terapevtski odmerek in interval zdravljenja za ovce temeljita na času, med katerim se srednje koncentracije florfenikola obdržijo nad MIK90 (glejte Prilogo III).
English: The applicant conducted a single field study to determine the efficacy and safety of the test product administered at 20 mg florfenicol/kg bodyweight intramuscularly once daily for three days to sheep with naturally acquired respiratory infections.
Slovenian: Predlagatelj je izvedel eno samo študijo na terenu, s katero je ugotavljal učinkovitost in varnost preskušanega zdravila v odmerku 20 mg florfenikola/kg telesne mase, ki so ga tri dni enkrat dnevno intramuskularno dajali ovcam z naravno pridobljeno okužbo dihal.
English: Luxembourg Intervet International B.V. Wim de Körverstraat 35
Slovenian: Luksemburg Intervet International B.V.
English: However, the CVMP agreed that section 4.9 of the Summary of Product Characteristics should be amended to clarify that the recommended treatment dose and treatment interval for sheep is based on the time mean florfenicol concentrations are maintained above MIC90.
Slovenian: Vendar pa se je odbor CVMP strinjal, da je treba poglavje 4.9 povzetka glavnih značilnosti zdravila dopolniti z vključitvijo pojasnila, da priporočeni odmerek in interval zdravljenja za ovce temeljita na času, med katerim se srednje koncentracije florfenikola ohranijo nad MIK90.
English: The application in question, submitted via the decentralised procedure, is an extension of the existing marketing authorisation of Nuflor 300 mg/ml solution for injection for cattle to add sheep as a target species.
Slovenian: Zadevna vloga za promet z zdravilom, predložena v okviru decentraliziranega postopka, je razširitev obstoječega dovoljenja za promet z zdravilom Nuflor 300 mg/ml raztopina za injiciranje za govedo, ki se mu doda ciljna živalska vrsta ovce.
English: The overall conclusion is that the efficacy dataset as a whole is adequate to support the efficacy of Nuflor 300 mg/ml solution for injection for cattle and sheep at the dose of 20 mg/kg daily via the intramuscular route of administration for three consecutive days in the treatment of Ovine Respiratory Disease associated with M. haemolytica and P. multocida.
Slovenian: Splošni zaključek je, da nabor podatkov kot celota ustrezno podpira učinkovitost zdravila Nuflor 300 mg/ml raztopina za injiciranje za govedo in ovce v odmerku 20 mg/kg dnevno, kadar se uporablja po intramuskularni poti tri zaporedne dni za zdravljenje bolezni dihal pri ovcah, povezanih z M. haemolytica in P. multocida.
English: • The MIC and pharmacokinetic data, taken together with what is known about florfenicol kill kinetics and post-antibiotic effect, support the recommended treatment interval (24 hours) for target respiratory tract pathogens with MIC up to 1 μg/ml when the product is administered to sheep at the proposed dose of 20 mg florfenicol/kg bodyweight,
Slovenian: • da podatki o MIK in farmakokinetični podatki, obravnavani skupaj z znanimi dejstvi o florfenikolovi kinetiki uničevanja in poantibiotičnem učinku, podpirajo priporočeni interval zdravljenja (24 ur) za ciljne povzročitelje bolezni dihal z MIK do 1 μg/ml, če se zdravilo daje ovcam v predlaganem odmerku 20 mg florfenikola/kg telesne mase;
English: The CVMP accepted that the MIC and pharmacokinetic data, taken together with what is known about florfenicol kill kinetics and post-antibiotic effect (PAE), support the recommended treatment interval (24 hours) for target pathogens with MIC up to 1 μg/ml and suggest that the proposed dose of 20 mg florfenicol/kg and the proposed between treatment interval of 24 hours should be appropriate for testing in the clinical setting for the treatment of respiratory infection associated with M. haemolytica and P. multocida.
Slovenian: Odbor CVMP je sprejel mnenje, da MIK in farmakokinetični podatki, obravnavani skupaj z znanimi dejstvi o florfenikolovi kinetiki uničevanja in poantibiotičnem učinku, podpirajo priporočeni interval zdravljenja (24 ur) za ciljne povzročitelje bolezni z MIK do 1 μg/ml in kažejo, da sta predlagani odmerek 20 mg florfenikola/kg in predlagani 24-urni interval med zdravljenjem ustrezna za testiranje zdravljenja okužb dihal z M. haemolytica in P. multocida v kliničnem okolju.
English: For sheep, the proposed indication is for treatment of respiratory tract infections due to Mannheimia haemolytica (M. haemolytica) and Pasteurella multocida (P. multocida) susceptible to florfenicol at a dose of 20 mg florfenicol/kg bodyweight intramuscular daily for three consecutive days.
Slovenian: Za ovce je predlagana indikacija zdravljenje okužb dihalnih poti, ki jih povzročata Mannheimia haemolytica (M. haemolytica) in Pasteurella multocida (P. multocida), občutljivi na florfenikol, z odmerkom 20 mg florfenikola/kg telesne mase, intramuskularno enkrat dnevno, ki traja tri zaporedne dni.
English: The concern related to the efficacy of the product - in particular to the high failure rate - have been assessed and it is confirmed that the product is proved to be efficacious in the treatment of ovine respiratory disease associated with M. Haemolytica and P. multocida when administered at a dose of 20 mg/kg bodyweight once daily via the intramuscular route of administration for three days.
Slovenian: Skrb, povezana z učinkovitostjo zdravila, zlasti z visoko stopnjo neučinkovitosti zdravljenja, je bila ocenjena in dokazano je bilo, da je zdravilo učinkovito pri zdravljenju bolezni dihal pri ovcah, povezanih z M. Haemolytica in P. multocida, če se uporablja v odmerku 20 mg/kg telesne mase enkrat dnevno po intramuskularni poti, s trajanjem zdravljenja tri dni.
English: Pharmacokinetic studies showed that mean plasma concentrations remain above MIC90 (1 μg/ml) for up to 18 hours after administration of the product at the recommended treatment dose.
Slovenian: Farmakokinetične študije kažejo da srednja koncentracija v serumu ostane nad MIC90 (1 μg/ml) do 18 ur po dajanju zdravila v priporočenem odmerku.
English: Dose finding study
Slovenian: Študija za določitev odmerka
English: Overall, the benefit-risk balance is considered positive for Nuflor 300 mg/ml solution for injection for cattle and sheep.
Slovenian: Na splošno je bilo razmerje med tveganji in koristmi za zdravilo Nuflor 300 mg/ml raztopina za injiciranje za govedo in ovce ocenjeno kot pozitivno.
English: Amendments in the relevant sections of the summary of product characteristics, labelling and package leaflet
Slovenian: Dopolnila k ustreznemu poglavju v povzetku glavnih značilnosti zdravila,označevanju in navodilu za uporabo
English: Pharmaceutical form Strength Animal species Route of administration
Slovenian: Farmacevtska oblika Jakost
English: Having considered all data submitted in writing and in the oral explanation provided by the applicant the CVMP concluded that the available data are adequate to support the efficacy of Nuflor 300 mg/ml solution for injection for cattle and sheep at the dose of 20 mg/kg daily via the intramuscular route of administration for three consecutive days in the treatment of Ovine Respiratory Disease associated with M. haemolytica and P. multocida.
Slovenian: Ob upoštevanju predloženih pisnih podatkov in predlagateljevih ustnih razlag je odbor CVMP sklenil, da razpoložljivi podatki ustrezno podpirajo učinkovitost zdravila Nuflor 300 mg/ml raztopina za injiciranje za govedo in ovce, če se uporablja tri zaporedne dni v dnevnem odmerku 20 mg/kg po intramuskularni poti za zdravljenje bolezni dihal pri ovcah, povezanih z M. haemolytica in P. multocida.
English: Mean florfenicol concentration in serum remained above 1 μg/ml (MIC90) for up to 18 hours following administration of the product at the recommended treatment dose.
Slovenian: Srednja koncentracija florfenikola v serumu se je po uporabi priporočenega odmerka zdravila še do 18 ur obdržala nad 1 μg/ml (MIK90).
English: Linear trend analyses of Day 4 and Day 6 rectal temperature data (primary variable) suggest that a dose response plateau was achieved at the florfenicol 20 mg/kg dosage.
Slovenian: Analize linearnih trendov v podatkih o rektalni temperaturi na 4. in 6. dan (primarna spremenljivka) kažejo, da je bil z odmerkom florfenikola 20mg/kg dosežena raven odziva na odmerek.Sekundarne spremenljivke (npr. smrtnost, odkriti povzročitelji, masa pljuč, masa lezije)
English: The data suggest that if florfenicol concentrations in plasma/tissue are above the MIC for in excess of two hours, there is likely to be a marked post-antibiotic effect.
Slovenian: Podatki kažejo, da je izrazit poantibiotični učinek verjeten, če so koncentracije florfenikola v plazmi/tkivu višje od MIK več kot dve uri.
English: Belgium Intervet International B.V. Wim de Körverstraat 35
Slovenian: Velika Britanija Intervet International B.V.
English: Name
Slovenian: Ime zdravila
English: Secondary variables (e.g. mortality, pathogen recover, lung weight, lesion weight) confirm that 20 mg/kg is superior to a dose of 10 mg/kg.
Slovenian: potrjujejo, da je odmerek 20 mg/kg boljši od odmerka 10 mg/kg.
English: Conclusion
Slovenian: Sklep
English: Version 4, 02/2016
Slovenian: Različica 4, 02/2016
English: These measures will help protect the environment.>
Slovenian: Taki ukrepi pomagajo varovati okolje.>
English: <The recommended dose is...>
Slovenian: <Priporočeni odmerek je ...>
English: <...> <6 months> <...> <1 year> <18 months> <2 years> <30 months> <3 years> <...>
Slovenian: <...> <6 mesecev> <...> <1 leto> <18 mesecev> <2 leti> <30 mesecev> <3 leta> <...>
English: <No special requirements <for disposal>.>
Slovenian: <Ni posebnih zahtev <za odstranjevanje>.>
English: Ask your pharmacist if you need more information or advice.
Slovenian: Posvetujte se s farmacevtom, če potrebujete dodatne informacije ali nasvet.
English: <Clinical efficacy and safety>
Slovenian: <Klinična učinkovitost in varnost>
English: Pharmacotherapeutic group: {group}, ATC code: {code} <not yet assigned>
Slovenian: Farmakoterapevtska skupina: {skupina}, oznaka ATC: {oznaka} <še ni bila dodeljena>
English: See section 4.>
Slovenian: Glejte poglavje 4.>
English: <No data are available.> <Currently available data are described in section <4.8> <5.1> <5.2> but no recommendation on a posology can be made.>
Slovenian: < Podatkov ni na voljo.> <Trenutno razpoložljivi podatki so opisani v poglavju <4.8> <5.1> <5.2>, vendar priporočil o odmerjanju ni mogoče dati.>
English: <Interaction studies have only been performed in adults.>
Slovenian: <Študije medsebojnega delovanja so izvedli le pri odraslih.>
English: <Use in the paediatric population>
Slovenian: <Uporaba pri pediatrični populaciji>
English: INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS>
Slovenian: NAVODILA ZA PRIPRAVO RADIOFARMAKOV>
English: <The following information is intended for healthcare professionals only:>
Slovenian: <Naslednje informacije so namenjene samo zdravstvenemu osebju:>>
English: NN: {number} [national reimbursement number or other national number identifying the medicinal product]>
Slovenian: NN: {številka} [nacionalna številka povračila stroškov za zdravilo ali druga nacionalna številka za identifikacijo zdravila]>
English: <In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.>
Slovenian: <Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili.>
English: <No interaction studies have been performed.>
Slovenian: <Študij medsebojnega delovanja niso izvedli.>
English: <{(Invented) Name} is a biosimilar medicinal product.
Slovenian: <Zdravilo {(izmišljeno) ime} je podobno biološko zdravilo.
English: This means that <due to the rarity of the disease> <for scientific reasons> <for ethical reasons> it has not been possible to obtain complete information on this medicinal product.
Slovenian: To pomeni, da <zaradi redkosti bolezni> <iz znanstvenih razlogov> <iz etičnih razlogov> ni bilo mogoče pridobiti vseh podatkov o zdravilu.
English: <Environmental Risk Assessment (ERA)>
Slovenian: <Ocena tveganja za okolje>
English: <This medicinal product must not be mixed with other medicinal products except those mentioned in section <6.6> <and> <12>.>
Slovenian: <Zdravila ne smemo mešati z drugimi zdravili razen s tistimi, ki so omenjena v poglavju <6.6> <in> <12>.>
English: <Linearity/non-linearity>
Slovenian: <Linearnost/nelinearnost>
English: <The tablet can be divided into equal doses.>
Slovenian: <Tableta se lahko deli na enake odmerke.>
English: <Do not use this medicine if you notice {description of the visible signs of deterioration}.>
Slovenian: <Ne uporabljajte tega zdravila, če opazite {opis vidnih znakov kvarjenja}.>
English: <Biotransformation>
Slovenian: <Biotransformacija>
English: <ANNEX III> [For referral procedures]
Slovenian: <PRILOGA III> [For referral procedures]
English: <{DD/MM/YYYY}>
Slovenian: <{DD/MM/LLLL}>
English: {Name}
Slovenian: {Ime}
English: <Precautions to be taken before handling or administering the medicinal product>
Slovenian: <Previdnostni ukrepi potrebni pred ravnanjem z zdravilom ali dajanjem zdravila>
English: For referral procedures: Please refer to the guidance in the annotated QRD template for centralised procedures.]
Slovenian: [*For the printed material, please refer to the guidance of the annotated QRD template.]
English: See section 4.8 for how to report adverse reactions.> [For medicinal products subject to additional monitoring ONLY]
Slovenian: Glejte poglavje 4.8, kako poročati o neželenih učinkih.> [SAMO za zdravila, za katera se izvaja dodatno spremljanje varnosti.]
English: <Any unused medicinal product or waste material should be disposed of in accordance with local requirements.>
Slovenian: <Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.>
English: <This medicinal product is authorised in the Member States of the EEA under the following names:>
Slovenian: <Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni:>
English: <Do not throw away any medicines via wastewater <or household waste>.
Slovenian: <Zdravila ne smete odvreči v odpadne vode <ali med gospodinjske odpadke>.
English: < PC: {number} [product code]
Slovenian: < PC: {številka} [koda zdravila]
English: - <if you are allergic to {active substance(s)} or any of the other ingredients of this medicine (listed in section 6).>
Slovenian: - <če ste alergični na {zdravilno(e) učinkovino(e)} ali katero koli sestavino tega zdravila (navedeno v poglavju 6).>
English: <Date of first authorisation: {DD month YYYY}>
Slovenian: <Datum prve odobritve: <{DD. mesec LLLL}>
English: Do not use this medicine after the expiry date which is stated on the <label> <carton> <bottle> <...> <after {abbreviation used for expiry date}.> <The expiry date refers to the last day of that month.>
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na <nalepki> <škatli> <steklenici> <...> <poleg oznake {okrajšava za rok uporabnosti}.> <Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.>
English: <This medicine has been authorised under “exceptional circumstances”.
Slovenian: <Zdravilo je pridobilo dovoljenje za promet v “izjemnih okoliščinah”.
English: <{Invented name} has <no or negligible influence> <minor influence> <moderate influence> <major influence> on the ability to drive and use machines.>
Slovenian: <Zdravilo { izmišljeno ime} <nima vpliva ali ima zanemarljiv vpliv > <ima blag vpliv> <ima zmeren vpliv> <ima pomemben vpliv> na sposobnost vožnje in upravljanja s stroji.>
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in HYPERLINK "http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc" Appendix V.*
Slovenian: Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v HYPERLINK "http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc" Prilogi V.*
English: <This medicinal product is for diagnostic use only.>
Slovenian: <Zdravilo je samo za diagnostične namene.>
English: X with <food> <and> <,> <drink> <and> <alcohol>
Slovenian: Zdravilo X skupaj 
 <z> <hrano> <in> <,> <pijačo> <in> <alkoholom>
English: You can also report side effects directly via the national reporting system listed in HYPERLINK "http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc"Appendix V.* By reporting side effects you can help provide more information on the safety of this medicine.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v HYPERLINK "http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc" Prilogi V.* S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: Pregnancy <and> <,> breast-feeding <and fertility>
Slovenian: Nosečnost <in> <,> dojenje <in plodnost>
English: <If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your <doctor> <or> <pharmacist> for advice before taking this medicine.>
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z<zdravnikom> <ali> <farmacevtom>, preden vzamete to zdravilo.>
English: <Justification for not including Braille accepted.>
Slovenian: <Sprejeta je utemeljitev, da Braillova pisava ni potrebna.>
English: DOSIMETRY>
Slovenian: DOZIMETRIJA>
English: <Tell your <doctor> <or> <pharmacist> if you are <taking> <using>, have recently <taken> <used> or might <take> <use> any other medicines.>
Slovenian: <Obvestite <zdravnika> <ali> <farmacevta>, če <jemljete> <uporabljate>, ste pred kratkim <jemali> <uporabljali> ali pa boste morda začeli <jemati> <uporabljati> katero koli drugo zdravilo.>
English: <Not all pack sizes may be marketed.>
Slovenian: <Na trgu morda ni vseh navedenih pakiranj.>
English: <Do not take a double dose to make up for a forgotten <tablet> <dose> <…>.>
Slovenian: <Ne vzemite dvojnega odmerka, če ste pozabili vzeti <prejšnjo tableto> <prejšnji odmerek> <…>.>
English: <Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.>
Slovenian: <V predkliničnih študijah so učinke opazili samo pri izpostavljenosti, ki je močno presegala največjo izpostavljenost pri človeku, kar kaže na majhen pomen za klinično uporabo.>