natgillin/translations-raw huggingface dataset:
The choice of the selected positive control product and its dosing regimen were considered by the Committee, as well as whether it is appropriate to compare a time-dependent antimicrobial (florfenicol) and a concentration-dependent antimicrobial (enrofloxacin). 
CVMP je preučil izbiro uporabljenega zdravila za pozitivno kontrolo in način njegovega odmerjanja ter tudi primernost primerjave časovno odvisnega antimikrobnega zdravila (florfenikola) in od koncentracije odvisnega antimikrobnega zdravila (enrofloksacina).
In view of the uncertainties and lack of data, the Standing Committee concluded that the CVMP should reconsider the opinion and evaluate again the benefit-risk balance of Nuflor Swine Once 450 mg/kg solution for injection. 
Ob upoštevanju nejasnosti in pomanjkanja podatkov je stalni odbor zaključil, da bi moral CVMP ponovno preučiti mnenje in še enkrat oceniti razmerje med tveganji in koristmi za zdravilo Nuflor Swine Once 450 mg/kg raztopina za injiciranje.
The Standing Committee noted that the CVMP recommended the granting of the marketing authorisation of the product subject to a condition requesting further clinical data on the efficacy of the veterinary medicinal product. 
Upošteval je, da je CVMP priporočil odobritev vloge za pridobitev dovoljenja za promet z zdravilom pod pogojem, da se zagotovijo dodatni klinični podatki o učinkovitosti tega zdravila za uporabo v veterinarski medicini.
This control should preferably belong to a different class of antimicrobials for which sufficient efficacy has been demonstrated, e.g. tulathromycin. 
Priporočeno je, da uporabi kontrolno zdravilo iz druge skupine antimikrobnih zdravil, katerega učinkovitost je že bila dokazana, npr. tulatromicin.
The persistence of A. pleuropneumoniae in alveolar macrophages might be one possible explanation for these results, but is not verified by clinical data. 
Eden od možnih vzrokov za odstopanja bi lahko bila vztrajna prisotnost A. pleuropneumoniae v alveolarnih makrofagih, vendar pa tega ni mogoče potrditi s kliničnimi podatki.
The proposed dose is 30 mg florfenicol/kg bodyweight given by intramuscular administration as a single injection. 
Predlagani odmerek je 30 mg florfenikola/kg telesne mase, ki se ga daje intramuskularno z enkratnim injiciranjem.
The failure rate for Nuflor Swine Once varied from 0 to 56% at Day 11 and was similar to the comparator enrofloxacin with 0 to 42%. 
Stopnja neuspešnosti zdravljenja z zdravilom Nuflor Swine Once, zabeležena 11. dan, je znašala od 0 do 56 % in je bila podobna stopnji za primerjalno zdravilo enrofloksacin, ki se je gibala od 0 do 42 %.
The marketing authorisation holder should provide a GCP-compliant clinical field study. 
Imetnik dovoljenja za promet z zdravilom mora izvesti klinično terensko študijo v skladu z dobro klinično prakso.
Based on the available pharmacokinetic data in swine and limited experiments in other species it is reasonable to predict that florfenicol concentrations may be equal at the level as in plasma. 
Na podlagi razpoložljivih farmakokinetičnih podatkov za prašiče in nekaterih poskusov pri drugih živalskih vrstah pa je mogoče utemeljeno sklepati, da je koncentracija florfenikola na teh mestih enaka kot v plazmi.
The reasons for the observed large variation of failure rates in the clinical field study are not known and cannot be determined from this study, nor on basis of other data presented during this referral procedure. 
Razlogi za zelo spremenljive stopnje neuspešnosti zdravljenja, opažene v klinični terenski študiji, niso znani in jih je nemogoče ugotoviti iz študije ali na podlagi drugih podatkov, ki so bili predloženi med napotitvenim postopkom.
Concerns have been raised about the high failure rate observed in the pivotal field study and the choice and dose of the positive control product used in that field study. 
Zadržki so se pojavili zaradi visoke stopnje neuspešnosti zdravljenja, zabeležene med ključno terensko študijo, in izbire zdravila za pozitivno kontrolo ter njegovih odmerkov , uporabljenih v tej terenski študiji.
The Committee considered whether the proposed dose of 30 mg/kg bw intramuscularly once may lead to a long sub-therapeutic period (e.g. below the MIC) and thus to development of florfenicol resistance. 
Odbor je preučil, ali lahko predlagani enkratni intramuskularni odmerek 30 mg/kg telesne mase povzroči dolgotrajne koncentracije pod terapevtsko ravnijo (npr. pod MIK) in s tem razvoj odpornosti na florfenikol.
Also, the principle of singledose administration had been questioned in terms of the sustained concentration above the Minimum Inhibitory Concentration (MIC) and the increased potential for development of antimicrobial resistance. 
Vprašanja so se pojavila tudi glede dajanja enkratnega odmerka, in sicer glede vzdrževanja koncentracije nad minimalno inhibitorno koncentracijo (MIK) ter povečanega tveganja za razvoj odpornosti na antimikrobna zdravila.
The mean cumulative failure rate for Nuflor Swine Once 450 mg/ml solution for injection in this field study was 8.9% on Day 5 and 20.7% on Day 11. 
Povprečna kumulativna stopnja neuspešnosti zdravljenja z zdravilom Nuflor Swine Once 450 mg/ml raztopina za injiciranje, zabeležena v terenski študiji, je 5. dan znašala 8,9 %, 11. dan pa 20,7 %.
This referral under Article 33(4) of Directive 2001/82/EC was made due to concerns that the applicant had not satisfactorily demonstrated the clinical efficacy of Nuflor Swine Once 450 mg/ml solution for injection at a single intramuscular dose of 30 mg/kg bw in the treatment of swine respiratory disease. 
Napotitveni postopek v skladu s členom 33(4) Direktive 2001/82/ES je bil sprožen zaradi pomislekov, da predlagatelj ni v zadovoljivi meri dokazal klinične učinkovitosti zdravila Nuflor Swine Once 450 mg/ml raztopina za injiciranje pri enkratnem intramuskularnem odmerku 30 mg/kg telesne mase za zdravljenje bolezni dihal pri prašičih.
However, the efficacy could not be clearly confirmed in the pivotal multicentre randomised controlled field study. 
Vendar pa v ključni multicentrični, randomizirani, nadzorovani terenski študiji ni bilo mogoče jasno potrditi njegove učinkovitosti.
This is a ‘hybrid application' according to Article 13(3) Directive 2001/82/EC, as amended, referring to the reference product, Nuflor Swine 300 mg/ml solution for injection (FR/V/0118/001). 
V skladu s členom 13(3) dopolnjene Direktive 2001/82/ES gre za „hibridno vlogo‟, ki se nanaša na referenčno zdravilo Nuflor Swine Once 300 mg/ml raztopina za injiciranje (FR/V/0118/001).
The marketing authorisation holder should reconsider the selection of the treatment dose and should provide further clinical data to confirm the efficacy of the intended dosage in the treatment of Swine Respiratory Disease associated with the target pathogens A. pleuropneumoniae, P. multocida and H. parasuis under field conditions. 
Imetnik dovoljenja za promet z zdravilom mora ponovno preučiti predlagani odmerek in predložiti dodatne klinične dokaze, pridobljene v dejanskih razmerah na terenu, s katerimi bi potrdili, da je predlagani odmerek učinkovit pri zdravljenju bolezni dihal pri prašičih, ki so povezane s ciljnimi patogeni A. pleuropneumoniae, P. multocida in H. parasuis.
Notwithstanding, Nuflor Swine Once 450 mg/ml solution for injection at the proposed posology cannot fulfil the principles of responsible use of antimicrobials as stated in the CVMP strategy on antimicrobials 2011-2015 due to concerns for lack of efficacy. 
Ne glede na to zdravilo Nuflor Swine Once 450 mg/ml raztopina za injiciranje pri predlaganem odmerjanju zaradi pomislekov glede pomanjkanja učinkovitosti ne izpolnjuje načel preudarne rabe antimikrobnih zdravil, vključenih v strategijo CVMP o antimikrobnih zdravilih 2011-2015.
Nuflor Swine Once 450 mg/ml solution for injection differs from the reference veterinary medicinal product by a higher concentration of active substance, single administration, a change in therapeutic indication but also by a different co-solvent. 
Zdravilo Nuflor Swine Once 450 mg/ml raztopina za injiciranje se od referenčnih zdravil za uporabo v veterinarski medicini razlikuje po višji koncentraciji zdravilne učinkovine, enkratni aplikaciji, spremenjenih terapevtskih indikacijah in po drugačnem pomožnem topilu.
The Standing Committee noted that there are serious uncertainties in CVMP's opinion on Nuflor Swine Once 450 mg/kg solution for injection in relation to the benefit-risk assessment, in particular regarding the efficacy of the product and the appropriate dosing. 
Stalni odbor je opazil velike nejasnosti v mnenju CVMP o zdravilu Nuflor Swine Once 450 mg/kg raztopina za injiciranje pri oceni razmerja med tveganji in koristmi, zlasti v zvezi z učinkovitostjo zdravila in ustreznim odmerjanjem.
This product is intended for use in pigs for the treatment of respiratory infections caused by strains of Actinobacillus pleuropneumoniae, Haemophilus parasuis and Pasteurella multocida susceptible to florfenicol. 
To zdravilo je namenjeno zdravljenju prašičev z okužbami dihal, ki jih povzročajo sevi bakterij Actinobacillus pleuropneumoniae, Haemophilus parasuis in Pasteurella multocida, ki so občutljive za florfenikol.
Pharmacokinetic data suggest that the elimination of the active ingredient is independent of the formulation and the dosage as long as the absorption phase is completed. 
Na podlagi farmakokinetičnih podatkov je mogoče sklepati, da izločitev zdravilne učinkovine ni odvisna od sestave in odmerka, v kolikor je bila absorpcija zdravila uspešna.
Nuflor Swine Once at a single dose of 30 mg/kg bw IM leads to plasma concentration of florfenicol above 0.5 µg/ml for about 72 hours. 
Pri enkratnem intramuskularnem odmerku 30 mg/kg telesne mase zdravila Nuflor Swine Once koncentracija florfenikola v plazmi ostane nad 0,5 µg/ml približno 72 ur.
These issues remained unsolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the CMD(v) was started. 
Ta vprašanja so ostala nerešena, zato je bil sprožen napotitveni postopek v skladu s členom 33(1) Direktive 2001/82/ES, ki je bil napoten na usklajevalno skupino za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v veterinarski medicini (CMD(v)).
Having considered all data submitted in writing and in the oral explanation the CVMP concluded that: 
Podlaga za zavrnitev izdaje dovoljenj za promet z zdravilom Na podlagi predložene pisne dokumentacije in ustnih obrazložitev je CVMP zaključil, da:
Post-antibiotic effect and post-antibiotic sub inhibitory effect against florfenicol were observed for three P. multocida and three A. pleuropneumoniae strains with a MIC of 0.5 µg/ml in vitro. 
Postantibiotični učinek in subinhibitorni učinek po jemanju antibiotikov sta bila opažena pri treh sevih P. multocida in treh sevih A. pleuropneumoniae z MIK 0,5 µg/ml in vitro.
A positive control product should be used for comparison in a non-inferiority design. 
Uporabiti mora tudi zdravilo za pozitivno kontrolo za primerjavo učinkov, ki morajo biti najmanj enakovredni.
Infection sites for the pathogens in question include bronchial epithelia lining fluid, bronchial epithelium and alveolar macrophages. 
Kadar gre za zadevne patogene, so mesta okužbe bronhialna epitelijska tekočina, bronhialni epitelij in alveolarni makrofagi.
Nuflor Swine Once per se is not a classic long acting preparation and a single dose of 30 mg/ml is considered not sufficient to treat respiratory tract infections where some pathogens have a MIC of 1 µg/ml. 
Zdravilo Nuflor Swine Once kot tako ni klasično zdravilo z dolgotrajnim delovanjem in enkratni odmerek 30 mg/ml ne zadostuje za zdravljenje okužb dihalnih poti, pri katerih za nekatere patogene veljajo vrednosti MIK 1 µg/ml.
In order to address the concerns raised by the referral, the applicant presented all available efficacy data for Nuflor Swine Once 450 mg/ml solution for injection. 
Da bi razrešili vprašanja, sprožena z napotitvenim postopkom, je predlagatelj predložil vse razpoložljive podatke o učinkovitosti zdravila Nuflor Swine Once 450 mg/ml raztopina za injiciranje.
The dose of enrofloxacin was 2.5 mg/kg IM for 3 days according to the label. 
Enrofloksacin so dajali 3 dni v intramuskularnem odmerku 2,5 mg/kg, kot je bilo označeno na nalepki.
Nuflor Swine Once is indicated for the treatment of swine respiratory disease associated with susceptible Actinobacillus pleuropneumoniae, Haemophilus parasuis and Pasteurella multocida at a single intramuscular dose of 30 mg/kg bodyweight. 
Zdravilo Nuflor Swine Once je indicirano za zdravljenje bolezni dihal pri prašičih, ki jih povzročajo mikrobi Actinobacillus pleuropneumoniae, Haemophilus parasuis in Pasteurella multocida, z enkratnim intramuskularnim odmerkom 30 mg/kg telesne mase.
However, no pharmacokinetic data of the terminal phases are available which could allow for a robust comparison between Nuflor Swine Once 450 mg/ml solution for injection and conventional formulations in regard to duration of sub-therapeutic concentrations. 
Vendar pa ne obstajajo nobeni farmakokinetični podatki o končnih fazah, na podlagi katerih bi lahko zanesljivo primerjali sestavo zdravila Nuflor Swine Once 450 mg/ml raztopina za injiciranje z drugimi običajnimi pripravki glede trajanja koncentracij pod terapevtsko ravnijo.
In the field studies some isolates show a MIC of 1 µg/ml. 
V terenskih študijah so pri nekaterih izoliranih patogenih zabeležili MIK 1 µg/ml.
Considering the MIC data from most recent isolates, obtained from pigs suffering from respiratory disease in the last 5 years florfenicol exhibited consistent MICs with MIC ranges of 0.06-1 µg/ml for each of P. multocida and A. pleuropneumoniae, and 0.125-0.5 µg/ml for H. parasuis. 
Glede na podatke o MIK, pridobljenih iz izoliranih patogenov prašičev z boleznimi dihal v zadnjih 5 letih, so za florfenikol veljale enakomerne MIK, ki so znašale od 0,06 do 1 µg/ml za posamezni patogen P. multocida oziroma A. pleuropneumoniae ter od 0,125 do 0,5 µg/ml za H. parasuis.
The mean failure rate at Day 11 was 20.7% and 27.3% for Nuflor Swine Once and the reference product (Enrofloxacin 5% solution for injection), respectively, but a large variation in the failure rates at Day 11 from 0 to 56% was observed between sites. 
Povprečna stopnja neuspešnosti zdravljenja, zabeležena na 11. dan, je bila 20,7 % za zdravilo Nuflor Swine Once oziroma 27,3 % za referenčno zdravilo (5-odstotno raztopino enrofloksacina za injiciranje), vendar pa je bilo opaženo veliko odstopanje med posameznimi lokacijami, saj so se stopnje neuspešnosti gibale od 0 do 56 %.
Therefore, the CVMP concluded that the overall benefit-risk balance is negative and recommends the refusal of the granting of the marketing authorisation for Nuflor Swine Once 450 mg/ml solution for injection and the suspension of the existing marketing authorisations (see Annex I). 
Zato je CVMP zaključil, da je splošno razmerje med tveganji in koristmi negativno, in priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Nuflor Swine Once 450 mg/ml raztopina za injiciranje ter začasni umik obstoječih dovoljenj za promet z njim (glejte Prilogo I).
Nuflor Swine Once 450 mg/ml solution for injection contains florfenicol as active ingredient. 
Nuflor Swine Once 450 mg/ml raztopina za injiciranje vsebuje zdravilno učinkovino florfenikol.
For the reference product mean cumulative failure rates were 13.5% and 27.3% on Day 5 and Day 11, respectively. 
Povprečna kumulativna stopnja neuspešnosti zdravljenja z referenčnim zdravilom je 5. dan znašala 13,5 %, 11. dan pa 27,3 %.
Overall summary of the scientific evaluation of Nuflor Swine Once 450 mg/ml solution for injection 
Splošni povzetek znanstvenega vrednotenja zdravila Nuflor Swine Once 450 mg/ml raztopina za injiciranje
Therefore the CVMP recommends the refusal of the granting of the marketing authorisations for Nuflor Swine Once 450 mg/ml solution for injection and associated names and the suspension of the existing marketing authorisations. 
Zato je CVMP priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Nuflor Swine Once 450 mg/ml raztopina za injiciranje in povezanimi imeni ter začasni umik obstoječih dovoljenj za promet z zdravilom.
The Committee considered whether the plasma concentrations of Nuflor Swine Once 450 mg/ml solution for injection, when corrected for plasma protein binding, adequately correlate to pulmonary concentrations (e.g. target site) and whether this explains the high failure rate. 
Odbor je preučil, ali obstaja ustrezna korelacija med plazemskimi koncentracijami zdravila Nuflor Swine Once 450 mg/ml raztopina za injiciranje, ko se omogoči vezava na plazemske beljakovine, in pljučnimi koncentracijami (npr. na tarčnih mestih) ter ali je lahko ta korelacija vzrok za visoko stopnjo neuspešnosti zdravljenja.
The opinion recommended the granting of the marketing authorisation for Nuflor Swine Once 450 mg/ml solution for injection, subject to a condition to provide further efficacy data. 
V mnenju je priporočil odobritev vloge za pridobitev dovoljenja za promet z zdravilom Nuflor Swine Once 450 mg/ml raztopina za injiciranje pod pogojem, da predlagatelj zagotovi dodatne podatke o učinkovitosti.
The mean failure rate at Day 11 is 20.7% and 27.3% for Nuflor Swine Once and the comparator, respectively, but a large variation was observed between sites. 
Povprečna stopnja neuspešnosti zdravljenja, zabeležena 11. dan, je bila 20,7 % za zdravilo Nuflor Swine Once oziroma 27,3 % za primerjalno zdravilo, vendar pa je bilo opaženo veliko odstopanje med posameznimi lokacijami.
In addition, it cannot be ruled out that a single intramuscular dose of 30 mg/kg bw of this time-dependent antimicrobial may not be sufficient to treat respiratory tract infections, in particular when pathogens are associated with MIC values ≥1 μg/ml. 
Poleg tega ni mogoče povsem izključiti možnosti, da enkratni intramuskularni odmerek 30 mg/kg telesne mase tega časovno odvisnega antimikrobnega zdravila ne zadostuje za učinkovito zdravljenje okužb dihalnih poti, zlasti tistih, pri katerih za patogene veljajo vrednosti MIK ≥ 1 μg/ml.
The Committee considered whether there is an appreciable “post-antibiotic effect”, as well as intracellular effects, that can justify this long acting preparation, since plasma concentrations may not be maintained above MIC for the treatment period. 
Odbor je preučil, ali ima zdravilo tudi po zdravljenju dober antibiotični učinek in dober učinek znotraj celic, ki bi lahko upravičila uporabo dolgo delujočega zdravila glede na dejstvo, da med samim zdravljenjem plazemske koncentracije morda ne dosegajo vrednosti nad minimalno inhibitorno koncentracijo (MIK).
Treatment of acute respiratory tract infection in pigs with Nufor Swine Once at a single intramuscular dose of 30 mg/kg bw revealed high failure rates at Day 11 after treatment. 
Pri prašičih so na 11. dan po zdravljenju akutnih okužb dihalnih poti z zdravilom Nuflor Swine Once pri enkratnem intramuskularnem odmerku 30 mg/kg telesne mase opazili visoke stopnje neuspešnosti zdravljenja.
Based on these results, Nuflor Swine Once 450 mg/ml solution for injection at a single intramuscular dose of 30 mg/kg bodyweight proved to be non-inferior to the positive control enrofloxacin 5% solution for injection. 
Ti rezultati so pokazali, da je učinkovitost zdravila Nuflor Swine Once 450 mg/ml raztopina za injiciranje pri enkratnem intramuskularnem odmerku 30 mg/kg telesne mase najmanj enakovredna učinkovitosti 5-odstotne raztopine enrofloksacina za injiciranje.
• the observed high and variable clinical failure rates in the clinical field study on Day 11 posttreatment are considered unacceptable; 
• visoke in spremenljive stopnje klinične neuspešnosti zdravljenja, opažene v klinični terenski študiji
Thus, the impact on development of florfenicol resistance when used in the proposed dose of 30 mg/kg bw IM once compared to authorised dosing regimens can hardly be estimated. 
Zato je skoraj nemogoče oceniti, kako predlagani enkratni intramuskularni odmerki 30 mg/kg telesne mase vplivajo na razvoj odpornosti na florfenikol v primerjavi z odobrenimi načini odmerjanja.
• it cannot be ruled out that a single intramuscular dose of 30 mg/kg bw of this time-dependent antimicrobial may not be sufficient to treat respiratory tract infections, in particular when pathogens are associated with MIC values ≥1 μg/ml; 
• ni mogoče povsem izključiti možnosti, da enkratni intramuskularni odmerek 30 mg/kg telesne mase tega časovno odvisnega antimikrobnega zdravila ne zadostuje za učinkovito zdravljenje okužb dihalnih poti, zlasti tistih, pri katerih za patogene veljajo vrednosti MIK ≥ 1 μg/ml; in da vloga zaradi vprašljive učinkovitosti zdravila ne izpolnjuje pogojev za pridobitev dovoljenja.
Romania 
Romunija1
The applicant submitted an application for a decentralised procedure for Nuflor Swine Once 450 mg/ml solution for injection. 
Predlagatelj je predložil vlogo za pridobitev dovoljenja za promet z zdravilom Nuflor Swine Once 450 mg/ml raztopina za injiciranje po decentraliziranem postopku.
The applicant submitted a multicentre randomised controlled field study including a total of seven study sites in Spain, Germany and France to confirm the efficacy and field safety of Nuflor Swine Once 450 mg/ml solution for injection in the treatment of swine respiratory disease associated with A. pleuropneumoniae, P. multocida and H. parasuis. 
Z njo je želel potrditi učinkovitost in varnost zdravila Nuflor Swine Once 450 mg/ml raztopina za injiciranje, namenjenega zdravljenju bolezni dihal pri prašičih, ki jih povzročajo mikrobi A. pleuropneumoniae, P. multocida in H. parasuis.
Bulgaria 
Bulgarija1
Belgium Intervet International B.V. Wim de Körverstraat 35 
Nizozemska Intervet International B.V.
Austria 
Austrija1
The exposure of triazolam was reduced by 36%. 
Izpostavljenost triazolamu se je zmanjšala za 36 %.
*Cross reference to section 4.4. 
* Navzkrižno sklicevanje na poglavje 4.4.
See section 6.6 for further details. 
Glejte poglavje 6.6 za več podrobnosti.
- you suffer from liver problems. 
- imate težave z jetri.
Return the medicine to the pharmacist. 
Zdravilo vrnite farmacevtu.
Tell your doctor immediately. 
O tem takoj obvestite svojega zdravnika.
Children (1-12 years) 
Otroci (1-12 let)
Uncontrolled open-label studies suggest sustained long-term efficacy, although no controlled study has been conducted for longer than three months. 
Nekontrolirane odprte študije kažejo na trajno dolgoročno učinkovitost, čeprav nobena kontrolirana študija ni trajala dlje kot tri mesece.
EXP: After first opening: use within 90 days. 
EXP: Po prvem odprtju: uporabite v 90 dneh.
If this happens to you, do not drive or operate machinery. 
Če se to zgodi, ne vozite avtomobila in ne upravljajte strojev.
The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for Inovelon. 
Mehanizem tega tveganja ni znan, podatki, ki so na voljo, pa ne izključujejo možnosti povečanega tveganja z zdravilom Inovelon.
This medicinal product could have potential risk for the environment. 
To zdravilo lahko predstavlja tveganje za okolje.
Patients and carers should exercise caution until they are familiar with the potential effects of this medicinal product. 
Bolniki in negovalno osebje naj bodo previdni, dokler se ne seznanijo z možnimi učinki tega zdravila.
As such, drop attacks were used as one of the primary end points. 
Drop atake kot take so bile eno od primarnih končnih stanj.
The oral suspension should be shaken vigorously before every administration. 
Peroralno suspenzijo je treba pred vsakim dajanjem močno pretresti.
The study was mainly designed for safety and not adequately powered to show a difference with regards to the seizure efficacy variables. 
Študija je bila oblikovana predvsem za varnost in ni bila zasnovana tako, da bi pokazala razliko glede učinkovitostnih spremenljivk napadov.
Rufinamide was evenly distributed between erythrocytes and plasma. 
Rufinamid je bil enakomerno porazdeljen med eritrocite in plazmo.
Consult the doctor, even if these events occurred at any time in the past. 
Posvetujte se z zdravnikom, tudi če so se ti dogodki zgodili kadar koli prej.
These events led to rufinamide discontinuation in 20% of the cases. 
Ti dogodki so povzročili ukinitev rufinamida pri 20 % primerov.