FrancophonIA/ELRC3.0 huggingface dataset:
English: (1) children and adolescents less than 50 kg should preferably start the treatment with Lacosamide UCB 10 mg/ml syrup.
Slovenian: (1) Otroci in mladostniki, ki tehtajo manj kot 50 kg naj zdravljenje po možnosti začnejo z zdravilom Lakozamid UCB 10 mg/ml sirup.
English: PHARMACEUTICAL FORM AND CONTENTS 14 film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 14 filmsko obloženih tablet 4. teden
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Lacosamide UCB 50 mg film-coated tablets Each film-coated tablet contains 50 mg lacosamide.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Lakozamid UCB 50 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 50 mg lakozamida.
English: Adolescents and children weighing 50 kg or more and adults Use the measuring cup provided in the carton box.
Slovenian: Mladostniki in otroci, ki tehtajo 50 kg ali več, in odrasli • Uporabite merico, priloženo v škatli.
English: The safety profile of lacosamide in placebo-controlled (see study details in section 5.1) and in openlabel studies (n=408) in adjunctive therapy in children from 4 years of age was consistent with the safety profile observed in adults although the frequency of some adverse reactions (somnolence, vomiting and convulsion) was increased and additional adverse reactions (nasopharyngitis, pyrexia, pharyngitis, decreased appetite, lethargy and abnormal behaviour) have been reported in paediatric patients: nasopharyngitis (15.7 %), vomiting (14.7 %), somnolence (14.0 %), dizziness (13.5 %), pyrexia (13.0 %), convulsion (7.8 %), decreased appetite (5.9 %), pharyngitis (4.7 %), lethargy (2.7 %) and abnormal behaviour (1.7 %).
Slovenian: Varnostni profil lakozamida v študijah, nadzorovanih s placebom (glejte podrobnosti o študiji v poglavju 5.1), in v odprtih študijah (n = 408) pri dopolnilnem zdravljenju pri otrocih od 4. leta starosti, je bil skladen z varnostnim profilom, opaženim pri odraslih, čeprav se je pogostnost nekaterih neželenih učinkov (zaspanost, bruhanje in konvulzije) povečala in so pri pediatričnih bolnikih poročali o dodatnih neželenih učinkih (nazofaringitis, pireksija, faringitis, zmanjšan apetit, letargičnost in nenormalno vedenje): nazofaringitis (15,7 %), bruhanje (14,7 %), zaspanost (14,0 %), omotica (13,5 %), pireksija (13,0 %), konvulzije (7,8 %), zmanjšan apetit (5,9 %), faringitis (4,7 %), letargija (2,7 %) in nenormalno vedenje (1,7 %).
English: Diplopia Vision blurred
Slovenian: Očesne bolezni diplopija zamegljen vid
English: The tables below provide examples of volumes of solution for infusion per administration depending on prescribed dose and body weight.
Slovenian: Preglednice spodaj vsebujejo primere volumnov raztopine za infundiranje na uporabo glede na predpisani odmerek in telesno maso.
English: Lacosamide treatment has been associated with dizziness or blurred vision.
Slovenian: Zdravljenje z lakozamidom lahko povzroča omotico ali zamegljen vid.
English: The percent reduction over placebo based on analysis of covariance was 31.72 % (95 % CI: 16.342, 44.277).
Slovenian: Na podlagi analize kovariance je bilo ugotovljeno 31,72 -odstotno zmanjšanje teh napadov (95-% IZ: 16.342; 44.277).
English: Lacosamide 600 mg/day was also shown to be effective in controlled adjunctive therapy trials, although the efficacy was similar to 400 mg/day and patients were less likely to tolerate this dose because of CNS- and gastrointestinal-related adverse reactions.
Slovenian: Lakozamid v odmerku 600 mg/dan je bil v nadzorovanih raziskavah dopolnilnega zdravljenja učinkovit, vendar je bila učinkovitost podobna kot pri odmerku 400 mg/dan.
English: Outer carton / bottle
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLA /STEKLENICA
English: 0.6 ml/kg (6 mg/kg) Maximum recommended dose
Slovenian: 0,6 ml/kg (6 mg/kg) največji priporočeni odmerek
English: Bradycardia(1,2) Atrial Fibrillation Atrial Flutter (1,2)
Slovenian: Srčne bolezni atrioventrikularni blok(1,2) bradikardija(1,2)
English: Packs of 14, 28, 56 and 168 film-coated tablets in PVC/PVDC blister sealed with an aluminium foil.
Slovenian: Pakiranja po 14, 28, 56 in 168 filmsko obloženih tablet v PVC/PVDC pretisnih omotih, pokritih z aluminijasto folijo.
English: These reactions are variable in expression, but typically present with fever and rash and can be associated with involvement of different organ systems.
Slovenian: Te reakcije se izražajo različno, značilna pa sta povišana telesna temperatura in izpuščaj.
English: Nausea Vomiting Constipation Flatulence
Slovenian: Bolezni prebavil slabost bruhanje zaprtost flatulenca dispepsija suha usta driska
English: Stevens-Johnson syndrome(1) Toxic epidermal necrolysis(1)
Slovenian: sindrom(1) toksična epidermalna nekroliza(1)
English: EU/1/19/1383/004 EU/1/19/1383/005 EU/1/19/1383/006 EU/1/19/1383/007 EU/1/19/1383/008 EU/1/19/1383/009
Slovenian: EU/1/19/1383/024 EU/1/19/1383/025 EU/1/19/1383/026 EU/1/19/1383/027
English: 1 vial contains 20 ml Lacosamide UCB solution for infusion equivalent to 200 mg lacosamide.
Slovenian: 1 viala vsebuje 20 ml zdravila Lakozamid UCB 10 mg/ml raztopina za infundiranje, kar ustreza 200 mg lakozamida.
English: PHARMACEUTICAL FORM Solution for infusion.
Slovenian: FARMACEVTSKA OBLIKA raztopina za infundiranje Bistra, brezbarvna tekočina.
English: Fainting;
Slovenian: • omotica;
English: 0.5 ml/kg (5 mg/kg) Maximum recommended dose
Slovenian: 0,5 ml/kg (5 mg/kg) največji priporočeni odmerek
English: How to use Lacosamide UCB
Slovenian: Kako uporabljati zdravilo Lakozamid UCB
English: Each ml of syrup contains 10 mg lacosamide.
Slovenian: En mililiter sirupa vsebuje 10 mg lakozamida.
English: If you weigh 50 kg or more, your doctor may decide to start Lacosamide UCB treatment with a single “loading” dose of 200 mg. You would then start your ongoing maintenance dose 12 hours later.
Slovenian: Če tehtate 50 kg ali več, se lahko zdravnik odloči, da začne zdravljenje z zdravilom Lakozamid UCB z enkratnim začetnim “polnilnim” odmerkom 200 mg.
English: In paediatric patients weighing 50 kg or more and in adult patients with mild or moderate renal impairment a loading dose of 200 mg may be considered, but further dose titration (> 200 mg daily) should be performed with caution.
Slovenian: Pri pediatričnih bolnikih, ki tehtajo 50 kg ali več, in pri odraslih bolnikih z blago ali zmerno ledvično okvaro lahko uporabimo začetni (polnilni) odmerek 200 mg, vendar moramo biti pri nadaljnji titraciji odmerka (> 200 mg na dan) previdni.
English: Lacosamide UCB 100 mg film-coated tablets: yellow iron oxide (E172) Lacosamide UCB 150 mg film-coated tablets: yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172)
Slovenian: Lakozamid UCB 100 mg filmsko obložene tablete: rumeni železov oksid (E172) Lakozamid UCB 150 mg filmsko obložene tablete: rumeni železov oksid (E172), rdeči železov oksid (E172), črni železov oksid (E172)
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using Lacosamide UCB.
Slovenian: Če za vas velja kar koli od zgoraj navedenega (ali če o tem niste prepričani), se pred uporabo zdravila Lakozamid UCB posvetujte z zdravnikom ali farmacevtom.
English: Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in steklenici poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Lacosamide UCB.
Slovenian: Če za vas velja kar koli od zgoraj navedenega (ali če o tem niste prepričani), se pred jemanjem zdravila Lakozamid UCB posvetujte z zdravnikom ali farmacevtom.
English: If you get any side effects, talk to your doctor or pharmacist.
Slovenian: • Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: Statistically significant (p=0.0003) and clinically relevant reduction in partial-onset seizure frequency per 28 days from baseline to the maintenance period was observed between the lacosamide and the placebo group.
Slovenian: Med skupino z lakozamidom in skupino s placebom so opazili statistično značilno (p = 0,0003) in klinično pomembno zmanjšanje pogostnosti parcialnih napadov na 28 dni od izhodišča do vzdrževalnega obdobja.
English: A meta-analysis of randomised placebo-controlled trials of antiepileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour.
Slovenian: Majhno povečanje tveganja za pojav samomorilnega razmišljanja in vedenja je pokazala tudi metaanaliza randomiziranih, s placebom nadzorovanih kliničnih preskušanj antiepileptikov.
English: In the placebo-controlled trials of lacosamide in epilepsy patients, atrial fibrillation or flutter were not reported; however, both have been reported in open-label epilepsy trials and in post-marketing experience.
Slovenian: V preskušanjih lakozamida, nadzorovanih s placebom, pri bolnikih z epilepsijo o atrijski fibrilaciji ali undulaciji niso poročali.
English: In paediatric patients weighing 50 kg or more and in adult patients with severe renal impairment (CLCR ≤ 30 ml/min) or with end-stage renal disease, a maximum dose of 250 mg/day is recommended and the dose titration should be performed with caution.
Slovenian: Pri pediatričnih bolnikih, ki tehtajo 50 kg ali več, in pri odraslih bolnikih s hudo ledvično okvaro (CLCR ≤ 30 ml/min) ter s končno ledvično odpovedjo je priporočeni največji odmerek 250 mg/dan, pri titraciji odmerka pa je potrebna previdnost.
English: 200 mg (1 tablet Lacosamide UCB 200 mg)
Slovenian: 200 mg (1 tableta zdravila Lakozamid UCB 200 mg)
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Slovenian: Uporaba začetnega (polnilnega)
English: Pinkish, oval film-coated tablets with approximate dimensions of 10.4 mm x 4.9 mm, and debossed with ‘SP' on one side and ‘50' on the other side.
Slovenian: Rožnate, ovalne filmsko obložene tablete z merami približno 10,4 mm x 4,9 mm, z vtisnjeno oznako ‘SP' na eni strani in oznako ‘50' na drugi strani.
English: Children and adolescents weighing less than 50 kg Use the oral syringe provided in the carton box.
Slovenian: Otroci in mladostniki, ki tehtajo manj kot 50 kg • Uporabite brizgo za peroralno odmerjanje, priloženo v škatli.
English: Salmon, oval film-coated tablets with approximate dimensions of 15.1 mm x 7.0 mm, and debossed with ‘SP' on one side and ‘150' on the other side.
Slovenian: Lososovo rožnate, ovalne filmsko obložene tablete z merami približno 15,1 mm x 7,0 mm, z vtisnjeno oznako ‘SP' na eni strani in oznako ‘150' na drugi strani.
English: 150 mg tablet: yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
Slovenian: 150 mg tableta: rumeni železov oksid (E172), rdeči železov oksid (E172), črni železov oksid (E172)
English: One tablet of Lacosamide UCB 50 mg contains 50 mg lacosamide.
Slovenian: Ena tableta zdravila Lakozamid UCB 50 mg vsebuje 50 mg lakozamida.
English: Follow these steps the first time you take Lacosamide UCB:
Slovenian: Te korake izvedite ob vsaki uporabi zdravila Lakozamid UCB:
English: Intermediate Carton
Slovenian: Notranja škatla
English: 150 mg (1 tablet Lacosamide UCB 150 mg)
Slovenian: 150 mg (1 tableta zdravila Lakozamid UCB 150 mg)
English: the package marked ‘Week 3' contains 14 tablets of 150 mg,
Slovenian: teden' vsebuje 14 tablet po 150 mg,
English: This medicinal product contains 2.6 mmol (or 59.8 mg) sodium per vial.
Slovenian: Zdravilo vsebuje 2,6 mmol (ali 59,8 mg) natrija na vialo, kar je treba upoštevati pri bolnikih, ki so na dieti z nadzorovanim vnosom natrija.
English: The following table summarises the recommended posology in adjunctive therapy for children and adolescents weighing less than 50 kg.
Slovenian: Naslednja preglednica vsebuje povzetek priporočenega odmerjanja pri dopolnilnem zdravljenju pri otrocih in mladostnikih, ki tehtajo manj kot 50 kg.
English: INFORMATION IN BRAILLE Lacosamide UCB 200 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Lakozamid UCB 200 mg
English: Suicidal ideation and behaviour have been reported in patients treated with antiepileptic medicinal products in several indications.
Slovenian: Pri bolnikih, ki so se zaradi različnih indikacij zdravili z antiepileptiki, so poročali o samomorilnem razmišljanju in vedenju.
English: Gait disturbance Asthenia
Slovenian: Bolniki z ledvično okvaro
English: Abnormalities in liver function tests have been observed in placebo-controlled trials with lacosamide in adult patients with partial-onset seizures who were taking 1 to 3 concomitant antiepileptic medicinal products.
Slovenian: Odstopanja od normalnih vrednosti laboratorijskih preiskav Pri odraslih bolnikih s parcialnimi napadi, ki so sočasno jemali 1 do 3 antiepileptike, so pri s placebom kontroliranih preskušanjih z lakozamidom opazili odstopanja od normalnih vrednosti preiskav jetrne funkcije.
English: One tablet of Lacosamide UCB 150 mg contains 150 mg lacosamide.
Slovenian: Ena tableta zdravila Lakozamid UCB 150 mg vsebuje 150 mg lakozamida.
English: Following a 4-hour haemodialysis treatment, AUC of lacosamide is reduced by approximately 50 %.
Slovenian: Po 4-urni dializi se AUC lakozamida zmanjša za približno 50 %, zato je po dializi priporočljivo dodatno odmerjanje zdravila (glejte poglavje 4.2).
English: Use of a loading dose is not recommended in adolescents and children weighing less than 50 kg.
Slovenian: Uporaba začetnega (polnilnega) odmerka pri mladostnikih in otrocih, ki tehtajo manj kot 50 kg, ni priporočena.
English: Each vial of 20 ml solution for infusion contains 200 mg lacosamide.
Slovenian: Ena viala z 20 ml raztopine za infundiranje vsebuje 200 mg lakozamida.
English: Lacosamide UCB 200 mg are blue, oval film-coated tablets of approximately 16.6 mm x 7.8 mm with a debossed ‘SP' on one side and ‘200' on the other side.
Slovenian: Lakozamid UCB 200 mg filmsko obložene tablete Modre, ovalne filmsko obložene tablete z merami približno 16,6 mm x 7,8 mm, z vtisnjeno oznako ‘SP' na eni strani in oznako ‘200' na drugi strani.
English: NAME OF THE MEDICINAL PRODUCT Lacosamide UCB 10 mg/ml syrup
Slovenian: IME ZDRAVILA Lakozamid UCB 10 mg/ml sirup
English: Packs of 14, 28 and 56 film-coated tablets in PVC/PVDC blister sealed with an aluminium foil.
Slovenian: Pakiranja po 14, 28 in 56 filmsko obloženih tablet v PVC/PVDC pretisnih omotih, pokritih z aluminijasto folijo.
English: Lacosamide UCB 150 mg are salmon, oval film-coated tablets of approximately 15.1 mm x 7.0 mm with a debossed ‘SP' on one side and ‘150' on the other side.
Slovenian: Lakozamid UCB 150 mg filmsko obložene tablete Lososove barve, ovalne filmsko obložene tablete z merami približno 15,1 mm x 7,0 mm, z vtisnjeno oznako ‘SP' na eni strani in oznako ‘150' na drugi strani.
English: One tablet of Lacosamide UCB 100 mg contains 100 mg lacosamide.
Slovenian: Ena tableta zdravila Lakozamid UCB 100 mg vsebuje 100 mg lakozamida.
English: You may experience: dizziness; feeling sick (nausea) or being sick (vomiting); fits (seizures), heart beat problems such as a slow, fast or irregular heart beat, coma or a fall in blood pressure with rapid heartbeat and sweating.
Slovenian: • napadi (krči), težave s srčnim ritmom, kot je počasen, hiter ali nereden srčni utrip,, koma ali padec krvnega tlaka s hitrim bitjem srca in znojenje.
English: The exposure of the O-desmethyl metabolite was several-fold increased in patients with moderate and severe renal impairment.
Slovenian: Pri bolnikih z zmerno do hudo ledvično okvaro se je izpostavljenost O-desmetilnemu presnovku nekajkrat povečala.
English: Dosing oral syringe (10 ml graduated every 0.25 ml) with an adaptor (for children and adolescents from 4 years of age weighing less than 50 kg)
Slovenian: Brizga za peroralno odmerjanje (10 ml z graduacijskimi oznakami za vsakih 0,25 ml) z nastavkom (za otroke in mladostnike od 4. leta starosti, ki tehtajo manj kot 50 kg) Ena polna brizga za peroralno odmerjanje (10 ml) ustreza 100 mg lakozamida.
English: Lacosamide UCB 50 mg Lacosamide UCB 100 mg Lacosamide UCB 150 mg Lacosamide UCB 200 mg
Slovenian: Lakozamid UCB 50 mg Lakozamid UCB 100 mg Lakozamid UCB 150 mg Lakozamid UCB 200 mg
English: Carton 14 tablets - week 1
Slovenian: Škatla s 14 tabletami - 1. teden
English: Dizziness Headache
Slovenian: Jetrna okvara
English: 100 mg (1 tablet Lacosamide UCB 100 mg)
Slovenian: 100 mg (1 tableta zdravila Lakozamid UCB 100 mg)
English: 0.4 ml/kg (4 mg/kg) Maximum recommended dose
Slovenian: 0,4 ml/kg (4 mg/kg) največji priporočeni odmerek
English: Adolescents and children weighing 50 kg or more and adults When you take Lacosamide UCB on its own
Slovenian: Mladostniki in otroci, ki tehtajo 50 kg ali več, in odrasli Ko boste vzeli zdravilo Lakozamid UCB samostojno:
English: Take off the adaptor from the oral syringe (figure 2).
Slovenian: • z brizge za peroralno odmerjanje snemite nastavek (slika 2);
English: No clinically relevant difference in lacosamide exposure was observed comparing its pharmacokinetics in extensive metabolisers (EMs, with a functional CYP2C19) and poor metabolisers (PMs, lacking a functional CYP2C19).
Slovenian: Pri primerjavi farmakokinetike preiskovancev s hitro (funkcionalen encim CYP2C19) in počasno presnovo (pomanjkanje funkcionalnega encima CYP2C19) niso opazili klinično pomembnih razlik v izpostavljenosti lakozamidu.
English: Lacosamide plasma concentrations were not affected by carbamazepine and by valproic acid.
Slovenian: V preskušanjih medsebojnega delovanja z drugimi zdravili lakozamid ni pomembno vplival na plazemske koncentracije karbamazepina in valprojske kisline, prav tako ob uporabi karbamazepina in valprojske kisline plazemske koncentracije lakozamida niso bile spremenjene.
English: Interaction trials showed that lacosamide had no effect on the pharmacokinetics of digoxin.
Slovenian: Preskušanja medsebojnega delovanja z drugimi zdravili so pokazala, da lakozamid nima vpliva na farmakokinetiko digoksina, opazili pa niso niti klinično pomembnih interakcij med lakozamidom in metforminom.
English: The safety profile of lacosamide in placebo-controlled (see study details in section 5.1) and in openlabel studies (n=408) in adjunctive therapy in children from 4 years of age was consistent with the safety profile observed in adults although the frequency of some adverse reactions (somnolence, vomiting and convulsion) was increased and additional adverse reactions (nasopharyngitis, pyrexia, pharyngitis, decreased appetite, lethargy and abnormal behaviour) have been reported in paediatric patients: nasopharyngitis (15.7 %), vomiting (14.7 %), somnolence (14.0 %), dizziness (13.5 %),
Slovenian: Varnostni profil lakozamida v študijah, nadzorovanih s placebom (glejte podrobnosti o študiji v poglavju 5.1), in v odprtih študijah (n = 408) pri dopolnilnem zdravljenju pri otrocih od 4. leta starosti, je bil skladen z varnostnim profilom opaženim pri odraslih, čeprav se je pogostnost nekaterih neželenih učinkov (zaspanost, bruhanje in konvulzije) povečala in so pri pediatričnih bolnikih poročali o dodatnih neželenih učinkih, (nazofaringitis, pireksija, faringitis, zmanjšan apetit, letargičnost in nenormalno vedenje): nazofaringitis (15,7 %), bruhanje (14,7 %), zaspanost (14,0 %), omotica (13,5 %), pireksija (13,0 %), konvulzije (7,8 %), zmanjšan apetit (5,9 %), faringitis (4,7 %), letargija (2,7 %) in nenormalno vedenje (1,7 %).
English: If your doctor decides to stop your treatment with Lacosamide UCB, they will decrease the dose step by step.
Slovenian: Če ste prenehali uporabljati zdravilo Lakozamid UCB Če se bo zdravnik odločil prekiniti vaše zdravljenje z zdravilom Lakozamid UCB, bo odmerek zmanjševal po korakih.
English: INFORMATION IN BRAILLE Lacosamide UCB 150 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Lakozamid UCB 150 mg
English: Suicide attempt (1) Suicidal ideation Hallucination (1)
Slovenian: agresija agitacija(1) evforično razpoloženje(1) psihotična motnja(1) poskus samomora(1) samomorilno razmišljanje halucinacije(1)
English: 50 mg (1 tablet Lacosamide UCB 50 mg)
Slovenian: 50 mg (1 tableta zdravila Lakozamid UCB 50 mg)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister label
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
English: 1 ml Lacosamide UCB solution for infusion contains 10 mg lacosamide.
Slovenian: 1 ml zdravila Lakozamid UCB 10 mg/ml raztopina za infundiranje vsebuje 10 mg lakozamida.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA Not applicable
Slovenian: EDINSTVENA OZNAKA - V BERLJIVI OBLIKI Navedba smiselno ni potrebna
English: In particular, tell your doctor or pharmacist if you are taking any of the following medicines that affect your heart - this is because Lacosamide UCB can also affect your heart: medicines to treat heart problems; medicines which can increase the “PR interval” on a scan of the heart (ECG or electrocardiogram) such as medicines for epilepsy or pain called carbamazepine, lamotrigine or pregabalin; medicines used to treat certain types of irregular heart beat or heart failure.
Slovenian: Zdravniku ali farmacevtu povejte še zlasti, če jemljete katero koli od naslednjih zdravil, ki vplivajo na vaše srce; razlog za to je, da zdravilo Lakozamid UCB prav tako vpliva na vaše srce:
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Vial
Slovenian: PODATKI, KI MORAJO BITI NAVEDENI NA STIČNIH OVOJNINAH Viala
English: the package marked ‘Week 2' contains 14 tablets of 100 mg,
Slovenian: teden' vsebuje 14 tablet po 100 mg,
English: Lacosamide UCB 100 mg are dark yellow, oval film-coated tablets of approximately 13.2 mm x 6.1 mm with a debossed ‘SP' on one side and ‘100' on the other side.
Slovenian: Lakozamid UCB 100 mg filmsko obložene tablete Temno rumene, ovalne filmsko obložene tablete z merami približno 13,2 mm x 6,1 mm, z vtisnjeno oznako ‘SP' na eni strani in oznako ‘100' na drugi strani.
English: Lacosamide UCB syrup contains sodium.
Slovenian: Zdravilo Lakozamid UCB vsebuje natrij
English: Tablet coat polyvinyl alcohol polyethylene glycol 3350 talc titanium dioxide (E171)
Slovenian: Obloga tablete polivinilalkohol polietilenglikol 3350 smukec titanov dioksid (E171)
English: The packages are marked with ‘week 1 (2, 3 or 4)'.
Slovenian: Pakiranja so označena ‘1.
English: See section 4.
Slovenian: pakiranje z oznako ‘4.
English: To be used twice daily for children from 4 years of age weighing less than 20 kg Weight
Slovenian: Uporaba dvakrat na dan za otroke od 4. leta starosti, ki tehtajo manj kot 20 kg Telesna masa
English: Adolescents and children weighing 50 kg or more and adults When you use Lacosamide UCB on its own
Slovenian: Mladostniki in otroci, ki tehtajo 50 kg ali več, in odrasli Ko zdravilo Lakozamid UCB uporabljate samostojno:
English: A single loading dose of 200 mg approximates steady-state concentrations comparable to 100 mg twice daily oral administration.
Slovenian: Doseganje koncentracij v stanju dinamičnega ravnovesja pri enkratnem začetnem (polnilnem) odmerku 200 mg je primerljivo s koncentracijami pri peroralnemu jemanju 100 mg dva krat na dan.
English: What Lacosamide UCB is used for
Slovenian: Za kaj uporabljamo zdravilo Lakozamid UCB
English: Sore throat (pharyngitis);
Slovenian: • vnetje žrela (faringitis);
English: Carton 14 tablets - week 2
Slovenian: Škatla s 14 tabletami - 2. teden
English: Lacosamide UCB 200 mg film-coated tablets: indigo carmine aluminium lake (E132) 6.2 Incompatibilities
Slovenian: Lakozamid UCB 200 mg filmsko obložene tablete: indigotin (E132)
English: To be taken twice daily for children from 4 years of age weighing less than 20 kg Weight
Slovenian: Jemanje dvakrat na dan za otroke od 4. leta starosti, ki tehtajo manj kot 20 kg Telesna masa
English: INFORMATION IN BRAILLE Lacosamide UCB 50 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Lakozamid UCB 50 mg
English: Ear and labyrinth disorders
Slovenian: Ušesne bolezni, vključno z motnjami labirinta vrtoglavica tinitus
English: Carton 14 tablets - week 3
Slovenian: Škatla s 14 tabletami - 3. teden
English: Lacosamide UCB 150 mg film-coated tablets Each film-coated tablet contains 150 mg lacosamide.
Slovenian: Lakozamid UCB 150 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 150 mg lakozamida.