FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Na podlagi farmakokinetičnih podatkov je mogoče sklepati, da izločitev zdravilne učinkovine ni odvisna od sestave in odmerka, v kolikor je bila absorpcija zdravila uspešna.
English: 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.
Slovenian: 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.
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: 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)).
English: Having considered all data submitted in writing and in the oral explanation the CVMP concluded that:
Slovenian: Podlaga za zavrnitev izdaje dovoljenj za promet z zdravilom Na podlagi predložene pisne dokumentacije in ustnih obrazložitev je CVMP zaključil, da:
English: 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.
Slovenian: 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.
English: A positive control product should be used for comparison in a non-inferiority design.
Slovenian: Uporabiti mora tudi zdravilo za pozitivno kontrolo za primerjavo učinkov, ki morajo biti najmanj enakovredni.
English: Infection sites for the pathogens in question include bronchial epithelia lining fluid, bronchial epithelium and alveolar macrophages.
Slovenian: Kadar gre za zadevne patogene, so mesta okužbe bronhialna epitelijska tekočina, bronhialni epitelij in alveolarni makrofagi.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The dose of enrofloxacin was 2.5 mg/kg IM for 3 days according to the label.
Slovenian: Enrofloksacin so dajali 3 dni v intramuskularnem odmerku 2,5 mg/kg, kot je bilo označeno na nalepki.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: In the field studies some isolates show a MIC of 1 µg/ml.
Slovenian: V terenskih študijah so pri nekaterih izoliranih patogenih zabeležili MIK 1 µg/ml.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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 %.
English: 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).
Slovenian: 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).
English: Nuflor Swine Once 450 mg/ml solution for injection contains florfenicol as active ingredient.
Slovenian: Nuflor Swine Once 450 mg/ml raztopina za injiciranje vsebuje zdravilno učinkovino florfenikol.
English: For the reference product mean cumulative failure rates were 13.5% and 27.3% on Day 5 and Day 11, respectively.
Slovenian: Povprečna kumulativna stopnja neuspešnosti zdravljenja z referenčnim zdravilom je 5. dan znašala 13,5 %, 11. dan pa 27,3 %.
English: Overall summary of the scientific evaluation of Nuflor Swine Once 450 mg/ml solution for injection
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Nuflor Swine Once 450 mg/ml raztopina za injiciranje
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: • the observed high and variable clinical failure rates in the clinical field study on Day 11 posttreatment are considered unacceptable;
Slovenian: • visoke in spremenljive stopnje klinične neuspešnosti zdravljenja, opažene v klinični terenski študiji
English: 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.
Slovenian: 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.
English: • 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;
Slovenian: • 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.
English: Romania
Slovenian: Romunija1
English: The applicant submitted an application for a decentralised procedure for Nuflor Swine Once 450 mg/ml solution for injection.
Slovenian: Predlagatelj je predložil vlogo za pridobitev dovoljenja za promet z zdravilom Nuflor Swine Once 450 mg/ml raztopina za injiciranje po decentraliziranem postopku.
English: 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.
Slovenian: 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.
English: Bulgaria
Slovenian: Bulgarija1
English: Belgium Intervet International B.V. Wim de Körverstraat 35
Slovenian: Nizozemska Intervet International B.V.
English: Austria
Slovenian: Austrija1
English: The exposure of triazolam was reduced by 36%.
Slovenian: Izpostavljenost triazolamu se je zmanjšala za 36 %.
English: *Cross reference to section 4.4.
Slovenian: * Navzkrižno sklicevanje na poglavje 4.4.
English: See section 6.6 for further details.
Slovenian: Glejte poglavje 6.6 za več podrobnosti.
English: - you suffer from liver problems.
Slovenian: - imate težave z jetri.
English: Return the medicine to the pharmacist.
Slovenian: Zdravilo vrnite farmacevtu.
English: Tell your doctor immediately.
Slovenian: O tem takoj obvestite svojega zdravnika.
English: Children (1-12 years)
Slovenian: Otroci (1-12 let)
English: Uncontrolled open-label studies suggest sustained long-term efficacy, although no controlled study has been conducted for longer than three months.
Slovenian: Nekontrolirane odprte študije kažejo na trajno dolgoročno učinkovitost, čeprav nobena kontrolirana študija ni trajala dlje kot tri mesece.
English: EXP: After first opening: use within 90 days.
Slovenian: EXP: Po prvem odprtju: uporabite v 90 dneh.
English: If this happens to you, do not drive or operate machinery.
Slovenian: Če se to zgodi, ne vozite avtomobila in ne upravljajte strojev.
English: The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for Inovelon.
Slovenian: Mehanizem tega tveganja ni znan, podatki, ki so na voljo, pa ne izključujejo možnosti povečanega tveganja z zdravilom Inovelon.
English: This medicinal product could have potential risk for the environment.
Slovenian: To zdravilo lahko predstavlja tveganje za okolje.
English: Patients and carers should exercise caution until they are familiar with the potential effects of this medicinal product.
Slovenian: Bolniki in negovalno osebje naj bodo previdni, dokler se ne seznanijo z možnimi učinki tega zdravila.
English: As such, drop attacks were used as one of the primary end points.
Slovenian: Drop atake kot take so bile eno od primarnih končnih stanj.
English: The oral suspension should be shaken vigorously before every administration.
Slovenian: Peroralno suspenzijo je treba pred vsakim dajanjem močno pretresti.
English: The study was mainly designed for safety and not adequately powered to show a difference with regards to the seizure efficacy variables.
Slovenian: Študija je bila oblikovana predvsem za varnost in ni bila zasnovana tako, da bi pokazala razliko glede učinkovitostnih spremenljivk napadov.
English: Rufinamide was evenly distributed between erythrocytes and plasma.
Slovenian: Rufinamid je bil enakomerno porazdeljen med eritrocite in plazmo.
English: Consult the doctor, even if these events occurred at any time in the past.
Slovenian: Posvetujte se z zdravnikom, tudi če so se ti dogodki zgodili kadar koli prej.
English: These events led to rufinamide discontinuation in 20% of the cases.
Slovenian: Ti dogodki so povzročili ukinitev rufinamida pri 20 % primerov.
English: The doctor may need to adjust the dose.
Slovenian: Morda bo moral zdravnik prilagoditi odmerek.
English: It has been shown that in the offspring of women with epilepsy, the prevalence of malformations is two to three times greater than the rate of approximately 3% in the general population.
Slovenian: Izkazalo se je, da je pri otrocih žensk z epilepsijo prevalenca malformacij dvakrat do trikrat večja od približno 3-odstotne prevalence v splošni populaciji.
English: If you forget to take a dose, continue taking the medicine as normal.
Slovenian: Če ste pozabili vzeti en odmerek, še naprej jemljite zdravilo kot navadno.
English: Environmental Risk Assessment (ERA):
Slovenian: Ocena tveganja za okolje:
English: Signs and symptoms of this disorder were diverse; however, patients typically, although not exclusively, presented with fever and rash associated with other organ system involvement.
Slovenian: Znaki in simptomi tega sindroma so bili različni; vendar so bolniki tipično, čeprav ne izključno, imeli vročino in izpuščaj, ki sta bila povezana s prizadetostjo drugih organskih sistemov.
English: Risk related to epilepsy and antiepileptic medicinal products in general:
Slovenian: Tveganje, ki je povezano z epilepsijo in antiepileptičnimi zdravili nasploh:
English: After first opening: 90 days.
Slovenian: 3 leta Po prvem odprtju: 90 dni
English: Do not reduce the dose or stop this medicine unless the doctor tells you to.
Slovenian: Ne zmanjšujte odmerka in ne prenehajte jemati zdravila, razen če vam tako naroči zdravnik.
English: The maximum daily dose will depend on whether or not you are also taking valproate.
Slovenian: Največji dnevni odmerek je odvisen od tega, ali jemljete tudi valproat.
English: As dose increases, the bioavailability decreases.
Slovenian: S povečevanjem odmerka se biološka uporabnost zmanjšuje.
English: Talk to your doctor or pharmacist if:
Slovenian: Posvetujte se z zdravnikom ali farmacevtom, če:
English: Do not take Inovelon:
Slovenian: Ne jemljite zdravila Inovelon:
English: The effect was modest to moderate.
Slovenian: Učinek je bil skromen do zmeren.
English: Manufacturer: Eisai Manufacturing Ltd, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, UK.
Slovenian: Izdelovalec: Eisai Manufacturing Ltd, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, Velika Britanija
English: The formation of small amounts of glutathione conjugates cannot be completely excluded.
Slovenian: Nastanek majhnih količin konjugatov glutationa ni popolnoma izključen.
English: Central Nervous System reactions
Slovenian: Reakcije centralnega živčnega sistema
English: Wash the syringe with clean water and dry thoroughly.
Slovenian: Brizgo izperite s čisto vodo in jo dobro osušite.
English: Depending on the individual sensitivity, rufinamide may have a minor to major influence on the ability to drive and use machines.
Slovenian: Odvisno od občutljivosti posameznika ima lahko rufinamid blag do pomemben vpliv na sposobnost vožnje in upravljanja s stroji.
English: Do not take a double dose to make up for forgotten dose.
Slovenian: Ne vzemite dvojnega odmerka, da bi nadomestili pozabljeni odmerek.
English: ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Slovenian: PRILOGA II A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA E. SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI DOVOLJENJA ZA PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH
English: A pharmacokinetic study in older healthy volunteers did not show a significant difference in pharmacokinetic parameters compared with younger adults.
Slovenian: Farmakokinetična študija pri starejših zdravih prostovoljcih ni pokazala signifikantnih razlik v farmakokinetičnih parametrih v primerjavi z mlajšimi odraslimi osebami.
English: No data are available (see section 5.2).
Slovenian: Podatkov ni na voljo (glejte poglavje 5.2).
English: Rufinamide was not genotoxic and had no carcinogenic potential.
Slovenian: Rufinamid ni bil genotoksičen in ni deloval kancerogeno.
English: A change in the dose of the other medicines may be needed as they may become slightly less effective when given with rufinamide.
Slovenian: Morda bo treba spremeniti odmerke drugih zdravil, saj lahko postanejo nekoliko manj učinkovita, če se uporabljajo z rufinamidom.
English: Pharmacotherapeutic group: antiepileptics, carboxamide derivatives; ATC code: N03AF03.
Slovenian: Farmakoterapevtska skupina: antiepileptiki, derivati karboksamida; oznaka ATC: N03AF03.
English: Multiple dosing of 7,200 mg/day was associated with no major signs or symptoms.
Slovenian: Odmerjanje večkrat po 7.200 mg na dan ni bilo povezano s pomembnejšimi znaki ali simptomi.
English: Taking these data into consideration, rufinamide should not be used during pregnancy, or in women of childbearing age not using contraceptive measures, unless clearly necessary.
Slovenian: Ob upoštevanju teh podatkov rufinamida ne smete uporabljati med nosečnostjo ali pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije, razen če je to nujno potrebno.
English: There is limited information on the use of rufinamide in this group, so the dose of your medicine may need to be increased more slowly.
Slovenian: Informacije o uporabi rufinamida v tej skupini so omejene in bo mogoče treba počasneje povečevati odmerek vašega zdravila.
English: Patients should be monitored during the switch over period.
Slovenian: V času prehoda je treba bolnika nadzirati.