FrancophonIA/ELRC3.0 huggingface dataset:
English: On 9 March 2010 the CVMP adopted a final opinion confirming the recommendation, included in its opinion of 11 November 2009, that variations are necessary to the terms of the marketing authorisations for veterinary medicinal products containing (fluoro)quinolones intended for foodproducing species where it has been identified that the SPC and package leaflet have not been updated in line with the precautionary phrases in the CVMP “Reflection paper on the use of fluoroquinolones in food-producing animals - Precautions for use in the SPC regarding prudent use guidance” (EMEA/CVMP/416168/2006).
Slovenian: Dne 9. marca 2010 je CVMP sprejel končno mnenje, v katerem je potrdil priporočilo iz mnenja z dne 11. novembra 2009, da so potrebne spremembe pogojev dovoljenj za promet z zdravili za uporabo v veterinarski medicini, ki vsebujejo (fluoro)kinolone in so namenjena živalskim vrstam za proizvodnjo živil, za katera je bilo ugotovljeno, da povzetek glavnih značilnosti zdravila in navodilo za uporabo nista usklajena s previdnostnimi stavki v „Razpravnem dokumentu CVMP o uporabi fluorokinolonov pri živalskih vrstah za proizvodnjo živali - previdnostni ukrepi za vstavitev v povzetek glavnih značilnosti zdravila s priporočili za preudarno rabo (EMEA/CVMP/416168/2006).“ Zaključki CVMP v zvezi z določenimi zdravili, ki so bili obravnavani v ponovnem pregledu, so prikazani v Dodatku II (Znanstveni zaključki) k mnenju CVMP.
English: Opinion following an Article 35F F referral for all veterinary medicinal products containing quinolones including fluoroquinolones intended for use in food-producing species
Slovenian: Mnenje v zvezi z napotitvijo v skladu s členom 35F F za vsa zdravila za uporabo v veterinarski medicini, ki vsebujejo kinolone, vključno s fluorokinoloni, in so namenjena za uporabo pri živalskih vrstah za proizvodnjo živil EMA/302885/2010
English: [Actavis logo]
Slovenian: [Actavis logotip]
English: Dose and frequency (1)
Slovenian: odmerjanje in pogostnost (1)
English: Date of first authorisation: 03 October 2011 Date of latest renewal:08 September 2016
Slovenian: Datum pridobitve dovoljenja za promet: 3. oktober 2011 Datum zadnjega podaljšanja: 8. september 2016
English: The results are consistent across age group.
Slovenian: Rezultati so skladni znotraj posamezne starostne skupine.
English: A risk of birth defects for your unborn child cannot be completely excluded.
Slovenian: Tveganje za defekte še nerojenega otroka ni mogoče popolnoma izključiti.
English: • Do not stop your treatment without your doctor's advice as this could increase your seizures.
Slovenian: • Ne prekinite zdravljenja brez nasveta vašega zdravnika, ker se lahko napadi še okrepijo.
English: Other unidentified components accounted only for 0.6 % of the dose.
Slovenian: Druge, neidentificirane sestavine predstavljajo le 0,6 % odmerka.
English: Levetiracetam Actavis must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Slovenian: Zdravilo Levetiracetam Actavis morate jemati dvakrat na dan, enkrat zjutraj in enkrat zvečer, vsak dan ob približno istem času.
English: Available data in children did not suggest impact on growth and puberty.
Slovenian: Podatki, ki so na razpolago pri otrocih, ne kažejo vpliva na rast in puberteto.
English: 31-546 Kraków
Slovenian: 31-546 Krakow
English: No impact on fertility was detected in animal studies (see section 5.3).
Slovenian: Plodnost V študijah na živalih vpliva na plodnost niso odkrili (glejte poglavje 5.3).
English: The mechanism of action of levetiracetam still remains to be fully elucidated.
Slovenian: Mehanizem delovanja Mehanizem delovanja levetiracetama še vedno ni popolnoma pojasnjen.
English: Your doctor will establish the best possible treatment of overdose.
Slovenian: Zdravnik vam bo določil najboljše možno zdravljenje prevelikega odmerjanja.
English: Elderly (65 years and older)
Slovenian: Posebne populacije Starejši (65 let in starejši)
English: The major metabolic pathway (24 % of the dose) is an enzymatic hydrolysis of the acetamide group.
Slovenian: Glavna presnovna pot (24 % odmerka) je encimska hidroliza acetamidne skupine.
English: He/she may decide if your dose should be adjusted.
Slovenian: Odloči se bo, ali je vaš odmerek potrebno prilagoditi.
English: This decrease is more pronounced during the third trimester (up to 60 % of baseline concentration before pregnancy).
Slovenian: To zmanjšanje koncentracije je bolj izrazito v času tretjega trimesečja (do 60% glede na običajno koncentracijo pred nosečnostjo).
English: No data are available.
Slovenian: Na razpolago ni nobenih podatkov.
English: The major route of excretion was via urine, accounting for a mean 95 % of the dose (approximately 93 % of the dose was excreted within 48 hours).
Slovenian: Glavna pot izločanja je z urinom, s katerim se izloči povprečno 95 % odmerka (približno 93 % odmerka se izloči v 48 urah).
English: If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor 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, preden vzamete to zdravilo.
English: This effect was pronounced for the younger infants, and subsided as age increased, to become negligible around 4 years of age.
Slovenian: Ta učinek je bil izrazit pri mlajših dojenčkih, z naraščanjem let je upadal in postal zanemarljiv okoli 4.
English: • if you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na levetiracetam, pirolidonske derivate ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
English: You should not drive or use machines until it is established that your ability to perform such activities is not affected.
Slovenian: Ne smete voziti ali upravljati s stroji, dokler ni potrjeno, da ni vpliva na vašo sposobnost izvajanja teh dejavnosti.
English: * The colourants are:
Slovenian: *barvila so:
English: Patients are advised not to drive or use machines until it is established that their ability to perform such activities is not affected.
Slovenian: Bolnikom svetujemo, naj ne vozijo ali upravljajo strojev, dokler ni potrjeno, da ni vpliva na njihovo sposobnost izvajanja teh dejavnosti.
English: • decreased number of all blood cell types;
Slovenian: • zmanjšano število vseh tipov krvnih celic
English: • limp or difficulty walking
Slovenian: • šepanje ali težave pri hoji
English: ETTEN-LEUR, 4879AC Netherlands
Slovenian: ETTEN-LEUR, 4879AC Nizozemska
English: Infants 1 to less than 6 months
Slovenian: Dojenčki od 1 do manj kot 6 mesecev
English: Levetiracetam Actavis may impair your ability to drive or operate any tools or machinery, as it may make you feel sleepy.
Slovenian: Zdravilo Levetiracetam Actavis lahko oslabi vašo sposobnost vožnje ali upravljanja z orodjem ali stroji, saj lahko povzroči zaspanost.
English: <1/100); rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000).
Slovenian: redki: (≥1/10.000 do <1/1.000) in zelo redki: (<1/10.000).
English: Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX14.
Slovenian: Farmakoterapevtska skupina: antiepileptiki, drugi antiepileptiki, Oznaka ATC: N03AX14.
English: • If you suffer from kidney problems, follow your doctor's instructions.
Slovenian: • če imate težave z ledvicami, upoštevajte zdravnikova navodila.
English: The daily dose is administered in two equally divided doses.
Slovenian: Dnevni odmerek se daje razdeljen v dva enaka odmerka.
English: The patients had to present with unprovoked partial seizures or with generalized tonic-clonic seizures only.
Slovenian: Bolniki so morali imeti neizzvane napade parcialnega izvora ali samo generalizirane tonično-klonične napade.
English: Therefore, patients should be monitored for signs of depression and/or suicidal ideation and behaviours and appropriate treatment should be considered.
Slovenian: Zato je treba bolnike med zdravljenjem nadzirati glede znakov depresije in/ali samomorilnega razmišljanja in vedenja ter razmisliti o ustreznem zdravljenju.
English: Example: if your daily dose is 1,000 mg, you might take 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.
Slovenian: Na primer: če je vaš dnevni odmerek 1000 mg, lahko vzamete 2 tableti po 250 mg zjutraj in 2 tableti po 250 mg zvečer.
English: To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in ml/min is needed.
Slovenian: Za uporabo te tabele je potrebno predhodno oceniti bolnikov očistek kreatinina (CLcr) v ml/min.
English: • A small number of people being treated with anti-epileptics such as Levetiracetam Actavis have had thoughts of harming or killing themselves.
Slovenian: • pri majhnem številu bolnikov, ki so se zdravili z antiepileptiki kot je zdravilo Levetiracetam Actavis, so se pojavile misli na samopoškodovanje ali samomor.
English: Adverse reactions are presented in the order of decreasing seriousness and their frequency is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to
Slovenian: Neželeni učinki so navedeni po padajoči resnosti in njihova pogostnost je opredeljena takole: zelo pogosti: (≥1/10); pogosti: (≥1/100 do <1/10); občasni: (≥1/1.000 do <1/100);
English: The apparent body weight adjusted clearance was approximately 30 % higher than in epileptic adults.
Slovenian: Navidezni telesni očistek je bil približno 30 % večji kot pri odraslih z epilepsijo.
English: The efficacy analysis consisted of 109 patients who had at least 24 hours of video EEG in both baseline and evaluation periods.
Slovenian: Analiza učinkovitosti je vključevala 109 bolnikov, ki so imeli vsaj 24-urni EEG posnetek v začetnem in evalvacijskem obdobju.
English: Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost za zdravilno učinkovino ali druge pirolidonske derivate ali katerokoli pomožno snov, navedeno v poglavju 6.1.
English: The pharmacokinetic results indicated that half-life was shorter (5.3 h) than for adults (7.2 h) and apparent clearance was faster (1.5 ml/min/kg) than for adults (0.96 ml/min/kg).
Slovenian: Farmakokinetični rezultati kažejo, da je bil razpolovni čas (5,3 ure) krajši kot pri odraslih (7,2 ure) in navidezni očistek večji (1,5 ml/min/kg) kot pri odraslih (0,96 ml/min/kg).
English: The total daily dose was administered twice daily.
Slovenian: Celokupni dnevni odmerek so dali dvakrat na dan.
English: • If you notice any slow down in the growth or unexpected puberty development of your child, please contact your doctor.
Slovenian: • če ste pri otrocih opazili počasnejšo rast ali nepričakovan razvoj v puberteti se posvetujte z zdravnikom.
English: • somnolence (sleepiness), headache.
Slovenian: • somnolenca (zaspanost), glavobol
English: The plasma half-life in adults was 7±1 hours and did not vary either with dose, route of administration or repeated administration.
Slovenian: Plazemski razpolovni čas pri odraslih je 7 ± 1 ur in se ne spreminja z odmerkom, potjo uporabe ali ponavljajočo se uporabo.
English: Specifar S.A 1, 28 Octovriou str. 123 51 Ag. Varvara Athens
Slovenian: Specifar S.A 1, 28 Octovriou str. 123 51 Ag. Varvara Atene
English: Ks= 0.45 in Term infants to 1 year old; ks= 0.55 in Children to less than 13 years and in adolescent female; ks= 0.7 in adolescent male.
Slovenian: ks = 0,45 pri dojenčkih do 1 leta starosti; ks = 0,55 pri otrocih, mlajših od 13 let in pri mladostnicah;
English: However subjects, who took levetiracetam in the long-term open label follow-up study, did not experience a worsening, on average, in their behavioural and emotional functioning; in particular measures of aggressive behaviour were not worse than baseline.
Slovenian: Kljub temu pa se osebam, ki so jemale olevetiracetam med dolgotrajno, odprto, sledilno študijo, v povprečju niso poslabšale njihove vedenjske in emocionalne funkcije; natančneje, rezultati meritev agresivnega obnašanja niso bili slabši od začetnih vrednosti.
English: You may take Levetiracetam Actavis with or without food.
Slovenian: Zdravilo Levetiracetam Actavis lahko vzamete s hrano ali brez.
English: Mogilska 80, 31-546 Kraków, Poland
Slovenian: Mogilska 80. 31-546 Krakow, Poljska
English: • Levetiracetam Actavis is used as a chronic treatment.
Slovenian: • Zdravilo Levetiracetam Actavis se uporablja za kronično zdravljenje.
English: In the population pharmacokinetic analysis conducted in patients from 1 month to 16 years of age, body weight was significantly correlated to apparent clearance (clearance increased with an increase in body weight) and apparent volume of distribution.
Slovenian: Pri farmakokinetični analizi populacije, ki so jo izvajali pri bolnikih od 1 meseca do 16. leta starosti, je telesna masa signifikantno korelirala z navideznim očistkom (očistek se je povečeval s povečevanjem telesne mase) in z navideznim volumnom porazdelitve.
English: Teva Operations Poland Sp. z. o. o. ul.
Slovenian: Teva Operations Poland Sp. z o.o.
English: The tablet formulation is not adapted for use in infants and children under the age of 6 years.
Slovenian: Farmacevtska oblika tableta ni prilagojena za uporabo pri dojenčkih in otrocih, mlajših od 6 let.
English: What you need to know before you take Levetiracetam Actavis Do not take Levetiracetam Actavis
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Levetiracetam Actavis Ne jemljite zdravila Levetiracetam Actavis
English: • infection;
Slovenian: • okužba
English: Due to possible different individual sensitivity, some patients might experience somnolence or other central nervous system related symptoms, especially at the beginning of treatment or following a dose increase.
Slovenian: Pri nekaterih bolnikih se lahko zaradi različne individualne občutljivosti predvsem na začetku zdravljenja ali po povečanju odmerka pojavi somnolenca ali drugi simptomi povezani s centralnim živčnim sistemom.
English: Pre-marketing data from clinical studies conducted in adults indicate that levetiracetam did not influence the serum concentrations of existing antiepileptic medicinal products (phenytoin, carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin and primidone) and that these antiepileptic medicinal products did not influence the pharmacokinetics of levetiracetam.
Slovenian: Antiepileptiki Predmarketinški podatki iz kliničnih študij izvedenih pri odraslih kažejo, da levetiracetam ne vpliva na serumsko koncentracijo ostalih protiepileptičnih zdravil (fenitoina, karbamazepina, valprojske kisline, fenobarbitala, lamotrigina, gabapentina in primidona), in da ta protiepileptična zdravila ne vplivajo na farmakokinetiko levetiracetama.
English: Results related to behavioural and emotional functioning indicated a worsening in levetiracetam treated patients on aggressive behaviour as measured in a standardised and systematic way using a validated instrument (CBCL - Achenbach Child Behaviour Checklist).
Slovenian: Rezultati povezani z vedenjskimi in emocionalnimi funkcijami kažejo pri bolnikih, ki se zdravijo z evetiracetamom , poslabšanje agresivnega obnašanja, ki se izmeri na standardiziran in sistematičen način z uporabo validiranega merskega instrumenta (CBCLAchenbach Child Behavior Checklist).
English: Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Slovenian: Levetiracetam je zdravilo proti epilepsiji (zdravilo za zdravljenje epileptičnih napadov).
English: Film-coated tablet (tablet).
Slovenian: filmsko obložene tablete (tablete)
English: General dose: between 1,000 mg and 3,000 mg each day.
Slovenian: Običajni odmerek: med 1000 mg in 3000 mg na dan.
English: 58.3 % of the levetiracetam treated patients and 23.3 % of the patients on placebo had at least a 50 % reduction in myoclonic seizure days per week.
Slovenian: 58,3 % bolnikov, ki so se zdravili z levetiracetamom, in 23,3 % bolnikov, ki so prejemali placebo, je imelo vsaj 50-odstotno zmanjšanje števila dni z miokloničnimi napadi na teden.
English: If levetiracetam has to be discontinued it is recommended to withdraw it gradually (e.g. in adults and adolescents weighing more than 50 kg: 500 mg decreases twice daily every two to four weeks; in infants older than 6 months, children and adolescents weighting less than 50 kg: dose decrease should not exceed 10 mg/kg twice daily every two weeks; in infants (less than 6 months): dose decrease should not exceed 7 mg/kg twice daily every two weeks).
Slovenian: Če je treba zdravljenje z levetiracetamom prekiniti je priporočljivo zdravljenje opustiti postopno (npr. pri odraslih in mladostnikih, težkih več kot 50 kg: zmanjševanje odmerka za 500 mg dvakrat na dan na vsaka dva tedna do štiri tedne; pri dojenčkih, starejših od 6 mesecev, otrocih in mladostnikih s telesno maso manj kot 50 kg: zmanjšanje odmerka ne sme preseči 10 mg/kg dvakrat na dan vsaka dva tedna; pri dojenčkih (mlajših od 6 mesecev): zmanjšanje odmerka ne sme preseči 7 mg/kg dvakrat na dan vsaka dva tedna).
English: In all of the above cases an oral solution should be used.
Slovenian: V vseh teh primerih se mora uporabiti peroralna raztopina.
English: Due to its complete and linear absorption, plasma levels can be predicted from the oral dose of levetiracetam expressed as mg/kg bodyweight.
Slovenian: Zaradi popolne in linearne absorpcije je koncentracijo levetiracetama v plazmi mogoče predvideti na podlagi peroralnega odmerka, izraženega v mg/kg telesne mase.
English: At the beginning of the treatment or at dose increase side effects like sleepiness, tiredness and dizziness may be more common.
Slovenian: Na začetku zdravljenja ali po povečanju odmerka lahko neželeni učinki, kotso na primer zaspanost, utrujenost in omotica, postanejo pogostejši.
English: CLcr (ml/min/1.73 m2) = ---------------------------- x 1.73 BSA subject (m2)
Slovenian: CLcr (ml/min/1,73 m2) = ---------------------------- x 1,73 BSA bolnika (m2)
English: In addition it partially reverses the reductions in GABA- and glycine-gated currents induced by zinc and β-carbolines.
Slovenian: Poleg tega delno preprečuje inhibicijo GABA in glicinskih kanalov povzročeno z Zn2+ in β- karbolini.
English: The requirements for submission of periodic safety update report for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal
Slovenian: • Redno posodobljena poročila o varnosti zdravila Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
English: The maximum dose is 1,500 mg twice daily.
Slovenian: Največji odmerek je 1500 mg dvakrat na dan.
English: Perforated unit dose blisters: 60 x 1 film-coated tablets (only available for 250 mg, 500 mg and 1,000 mg tablets).
Slovenian: Perforiranem pretisnem omotu za enkratni odmerek: 60 x 1 filmsko obloženih tablet (na voljo le za 250 mg, 500 mg in 1000 mg tablete).
English: When you will first start taking Levetiracetam Actavis, your doctor will prescribe you a lower dose (500 mg each day) during 2 weeks before giving you the lowest general dose of 1,000 mg.
Slovenian: Na začetku jemanja zdravila Levetiracetam Actavis vam bo zdravnik, preden vam bo predpisal najnižji običajni odmerek 1000 mg, za dva tedna predpisal nižji odmerek (500 mg vsak dan) .
English: Sunset Yellow (E110) colouring agent may cause allergic reactions.
Slovenian: Barvilo sončno rumeno FCF (E110) lahko povzroči alergijske reakcije.
English: What Levetiracetam Actavis is and what it is used for
Slovenian: Kaj je zdravilo Levetiracetam Actavis in za kaj ga uporabljamo
English: Levetiracetam 2,000 mg daily did not influence the pharmacokinetics of digoxin and warfarin; prothrombin times were not modified.
Slovenian: Levetiracetam v odmerku 2000 mg na dan ni vplival na farmakokinetiko digoksina in varfarina; protrombinski čas se ni spremenil.
English: Add-on therapy for infants aged from 1 month to less than 6 months
Slovenian: Dopolnilno zdravljenje za dojenčke stare od 1 do manj kot 6 mesecev
English: Swallow Levetiracetam Actavis tablets with a sufficient quantity of liquid (e.g. a glass of water).
Slovenian: Tablete zdravila Levetiracetam Actavis zaužijte z dovolj tekočine (npr. s kozarcem vode).
English: Dose in adults and adolescents (from 16 years of age):
Slovenian: Odmerjanje pri odraslih in mladostnikih (od 16.
English: One was obtained by hydroxylation of the pyrrolidone ring (1.6 % of the dose) and the other one by opening of the pyrrolidone ring (0.9 % of the dose).
Slovenian: (1,6 % odmerka), drugi z odprtjem pirolidonskega obroča (0,9 % odmerka).
English: In a study reflecting clinical practice, the concomitant antiepileptic medication could be withdrawn in a limited number of patients who responded to levetiracetam adjunctive therapy (36 adult patients out of 69).
Slovenian: V študiji, ki je odražala klinično prakso, je bilo mogoče pri omejenem številu bolnikov, ki so se odzvali na dopolnilno zdravljenje z levetiracetamom (36 od 69 odraslih bolnikov), prekiniti sočasno protiepileptično zdravljenje.
English: The active substance, levetiracetam, is a pyrrolidone derivative (S-enantiomer of α-ethyl-2-oxo-1-pyrrolidine acetamide), chemically unrelated to existing antiepileptic active substances.
Slovenian: Zdravilna učinkovina levetiracetam je pirolidonski derivat (S-enantiomer α-etil-2-okso-1pirolidinacetamida), ki kemično ni podoben drugim protiepileptičnim učinkovinam.
English: What Levetiracetam Actavis is and what it is used for What you need to know before you take Levetiracetam Actavis How to take Levetiracetam Actavis Possible side effects
Slovenian: Kaj je zdravilo Levetiracetam Actavis in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Levetiracetam Actavis Kako jemati zdravilo Levetiracetam Actavis
English: The starting dose for a child or adolescent of 25 kg should be 250 mg twice daily with a maximum dose of 750 mg twice daily.
Slovenian: Začetni odmerek za otroka ali mladostnika, težkega 25 kg, je 250 mg dvakrat na dan z največjim odmerkom 750 mg dvakrat na dan.
English: The extent of absorption of levetiracetam was not altered by food, but the rate of absorption was slightly reduced.
Slovenian: Hrana ne vpliva na obseg absorpcije levetiracetama, rahlo pa zmanjša hitrost absorpcije.
English: At 3,600 mg/kg/day, in only one of the 2 EFD studies, there was a slight decrease in foetal weight associated with a marginal increase in skeletal variations/minor anomalies.
Slovenian: Pri 3600 mg/kg/dan se je samo v eni od dveh študij embrio-fetalnega razvoja telesna masa plodu zanemarljivo zmanjšala v povezavi z marginalnim povečanjem skeletnih sprememb/manjših anomalij.
English: It was concluded that levetiracetam was not different (non inferior) from placebo with regard to the change from baseline of the Leiter-R Attention and Memory, Memory Screen Composite score in the per-protocol population.
Slovenian: Zaključili so, da se levetiracetam pri populaciji po protokolu ne razlikuje (ni manjvredno) od placeba glede spremembe od začetnih vrednosti rezultatov testiranja spomina in pozornosti (Leiter-R Attention and Memory, Memory Screen Composite).
English: If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.
Slovenian: Če imate kakršnekoli simptome depresije ali misli o samomoru ali oboje, se posvetujte z zdravnikom.