FrancophonIA/ELRC3.0 huggingface dataset:
English: Each package has 14 tablets, corresponding to 2 tablets per day for 7 days.
Slovenian: Vsako pakiranje ima 14 tablet, kar zadostuje za 7 dni jemanja po 2 tableti na dan.
English: It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Slovenian: Lahko vam škoduje, če imate fenilketonurijo, redko genetsko bolezen, pri kateri pride do kopičenja fenilalanina, ker se ne more ustrezno odstranjevati iz telesa.
English: For longer term treatment Vimpat tablets and syrup are available.
Slovenian: Za daljše zdravljenje so na voljo tablete in sirup zdravila Vimpat.
English: България Ю СИ БИ България ЕООД
Slovenian: Ю СИ БИ България ЕООД Teл.
English: Swallow the Vimpat tablet with a glass of water.
Slovenian: • Tableto zdravila Vimpat pogoltnite s kozarcem vode.
English: Vimpat is not recommended for children aged under 4 years.
Slovenian: Zdravilo Vimpat ni priporočeno pri otrocih, mlajših od 4 let.
English: Follow these steps each time you take Vimpat:
Slovenian: Te korake izvedite ob vsaki uporabi zdravila Vimpat:
English: Do not stop taking Vimpat without talking to your doctor, as your epilepsy may come back again or become worse.
Slovenian: • Ne prekinite jemanja zdravila Vimpat brez posvetovanja z zdravnikom, saj se lahko epilepsija spet pojavi ali poslabša.
English: Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
Slovenian: Sorbitol lahko povzroči prebavne motnje in blag odvajalni učinek.
English: Other medicines and Vimpat
Slovenian: Druga zdravila in zdravilo Vimpat
English: Do not use Vimpat if any of the above applies to you.
Slovenian: Zdravila Vimpat ne uporabljajte, če za vas velja kar koli od zgoraj navedenega.
English: You will start your treatment with a low dose of Vimpat, usually 50 mg twice a day, and increase it week by week.
Slovenian: Zdravljenje boste začeli z nizkim odmerkom zdravila Vimpat, običajno 50 mg dvakrat na dan, in ga iz tedna v teden povečevali.
English: They will help you decide if you should use Vimpat or not.
Slovenian: Pomagal se vam bo odločiti, ali naj uporabljate zdravilo Vimpat ali ne.
English: Vimpat syrup contains aspartame (E951), a source of phenylalanine, which may be harmful for people with phenylketonuria.
Slovenian: Zdravilo Vimpat sirup vsebuje aspartam (E951), ki je vir fenilalanina, ki je lahko škodljiv za bolnike s fenilketonurijo.
English: You would then start your ongoing maintenance dose 12 hours later.
Slovenian: Vzdrževalni odmerek boste začeli nato jemati 12 ur pozneje.
English: This medicine contains 59.8 mg sodium (main component of cooking/table salt) in each vial.
Slovenian: To zdravilo vsebuje 59,8 mg natrija (glavne sestavine kuhinjske soli) na vialo.
English: Do not take Vimpat if any of the above applies to you.
Slovenian: Zdravila Vimpat ne jemljite, če za vas velja kar koli od zgoraj navedenega.
English: Vimpat treatment initiation pack contains 4 different packages (one for each tablet strength) with 14 tablets each, for the first 2 to 4 weeks of therapy depending on the patient's response and tolerability.
Slovenian: Paket zdravila Vimpat za začetek zdravljenja vsebuje 4 različna pakiranja (eno za vsako jakost tablet), vsako s po 14 tabletami, ki glede na bolnikov odziv in prenašanje zdravila zadostuje za prva 2 do 4 tedne zdravljenja.
English: If your doctor decides to stop your treatment with Vimpat, they will decrease the dose step by step.
Slovenian: Če se bo zdravnik odločil prekiniti vaše zdravljenje z zdravilom Vimpat, bo odmerek zmanjševal po korakih.
English: Irritability Feeling drunk Injection site pain or discomfort (4) Irritation(4)
Slovenian: občutek pijanosti bolečina ali nelagodje na mestu infundiranja(4) draženje(4)
English: If you are taking Vimpat and you are experiencing symptoms of abnormal heartbeat (such as slow, rapid or irregular heartbeat, palpitations, shortness of breath, feeling lightheaded, fainting), seek medical advice immediately (see section 4).
Slovenian: Če jemljete zdravilo Vimpat in se pojavijo simptomi nepravilnega srčnega utripa (kot so počasen, hiter ali nepravilen srčni utrip, palpitacije, zasoplost, občutek vrtoglavice, omedlevica), takoj poiščite zdravniško pomoč (glejte poglavje 4).
English: Name and address of the manufacturer responsible for batch release Aesica Pharmaceuticals GmbH or
Slovenian: A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca, odgovornega za sproščanje serij Aesica Pharmaceuticals GmbH ali
English: Vimpat 10 mg/ml solution for infusion is an alternative for patients when oral administration is temporarily not feasible.
Slovenian: Zdravilo Vimpat 10 mg/ml raztopina za infundiranje je alternativa za bolnike, pri katerih peroralna uporaba trenutno ni mogoča.
English: Toxic epidermal necrolysis(1)
Slovenian: toksična epidermalna nekroliza(1)
English: You may take Vimpat with or without food.
Slovenian: Lakozamid se lahko jemlje s hrano ali brez nje.
English: UCB Magyarország Kft. Tel.: + 36-(1) 391 0060
Slovenian: Magyarország UCB Magyarország Kft. Tel.: + 36-(1) 391 0060
English: Vimpat may make you dizzy - this could increase the risk of accidental injury or a fall.
Slovenian: Zdravilo Vimpat lahko povzroča omotico, kar lahko poveča tveganje za naključne poškodbe ali padce.
English: This is equivalent to 3 % of the recommended maximum daily dietary intake of sodium for an adult.
Slovenian: To je enako 3 % priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
English: What Vimpat looks like and contents of the pack
Slovenian: Izgled zdravila Vimpat in vsebina pakiranja
English: In post-marketing experience, AV block (including second degree or higher AV block) has been reported.
Slovenian: V obdobju postmarketinških izkušenj, so poročali o atrioventrikularnem bloku (vključno z atrioventrikularnim blokom druge ali višje stopnje).
English: Vimpat tablets and syrup are bioequivalent.
Slovenian: Tablete in peroralni sirup zdravila Vimpat so bioekvivalentni.
English: Sorbitol (a type of sugar): This medicine contains 187 mg sorbitol in each ml.
Slovenian: • Sorbitol (vrsta sladkorja): To zdravilo vsebuje 187 mg sorbitola v ml. Sorbitol je vir fruktoze.
English: This is equivalent to 0.07 % of the recommended maximum daily dietary intake of sodium for an adult.
Slovenian: To je enako 0,07 % priporočenega največjega dnevnega vnosa natrija za odrasle.
English: Stevens-Johnson syndrome(1)
Slovenian: Stevens-Johnsonov sindrom(1)
English: Treatment initiation pack (in adolescent and children weighing 50 kg or more and adults only) Vimpat 50 mg film-coated tablets
Slovenian: Pakiranje za začetek zdravljenja (le za mladostnike in otroke, ki tehtajo 50 kg ali več, in odrasle) Vimpat 50 mg filmsko obložene tablete
English: Taking Vimpat on its own - This is for information only.
Slovenian: Samostojno jemanje zdravila Vimpat - to navodilo je le informativno.
English: Vimpat syrup contains sorbitol (E420).
Slovenian: Zdravilo Vimpat sirup vsebuje sorbitol (E420).
English: Thus, the 600 mg/day dose is not recommended.
Slovenian: 600 mg/dan ni priporočljiv.
English: Vimpat is available in packs of 14, 28, 56, 60, 14 x 1 and 56 x 1 film-coated tablets.
Slovenian: Zdravilo Vimpat je na voljo v pakiranjih po 14, 28, 56, 60, 14 x 1 in 56 x 1 filmsko obložena tableta.
English: Sodium (salt): This medicine contains 1.42 mg sodium (main component of cooking/table salt) in each ml.
Slovenian: • Natrij (sol): To zdravilo vsebuje 1,42 mg natrija (glavne sestavine kuhinjske soli) na ml.
English: Vimpat is used in adults, adolescents and children aged 4 years and older.
Slovenian: • Zdravilo Vimpat se uporablja pri odraslih, mladostnikih in otrocih, starih 4 leta in več.
English: Table: Start of the treatment (the first 4 weeks)
Slovenian: Preglednica: Začetek zdravljenja (prvi 4 tedni) Teden
English: Also, it is not known whether Vimpat passes into the breast milk.
Slovenian: Prav tako ni znano, ali zdravilo Vimpat prehaja v materino mleko.
English: Τηλ: + 357 22 05 63 00
Slovenian: Ltd Τηλ: + 357 22 05 63 00
English: Stevens-Johnson syndrome(1) Toxic epidermal necrolysis(1)
Slovenian: Stevens-Johnsonov sindrom(1) toksična epidermalna nekroliza(1)
English: Aspartame (E951): This medicine contains 0.032 mg aspartame in each ml.
Slovenian: • Aspartam (E951): To zdravilo vsebuje 0,032 mg aspartama v ml. Aspartam je vir fenilalanina.
English: Vimpat syrup contains sodium methyl parahydroxybenzoate (E219), which may cause allergic reactions (possibly delayed).
Slovenian: Zdravilo Vimpat sirup vsebuje natrijev metilparahidroksibenzoat (E219), ki lahko povzroča alergijske reakcije (možno z zakasnitvijo).
English: Rapid and uncontrollable movements of the eyes (nystagmus), blurred vision; A spinning sensation (vertigo), feeling drunk;
Slovenian: • hitri in nenadzorovani gibi oči (nistagmus), zamegljen vid;
English: If you forget to take Vimpat
Slovenian: Če ste pozabili vzeti zdravilo Vimpat
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients water for injections sodium chloride hydrochloric acid (for pH adjustment)
Slovenian: 6.1 Seznam pomožnih snovi voda za injekcije natrijev klorid klorovodikova kislina (za uravnavanje pH)
English: Propylene glycol (E1520): This medicine contains 2.14 mg propylene glycol in each ml.
Slovenian: • Propilenglikol (E1520): To zdravilo vsebuje 2,14 mg propilenglikola v ml.
English: This medicinal product contains 59.8 mg sodium per vial, equivalent to 3% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Slovenian: To zdravilo vsebuje 59,8 mg natrija na vialo, kar je enako 3 % največjega dnevnega vnosa natrija za odrasle osebe, ki ga priporoča SZO in znaša 2 g.
English: Elevations of ALT to ≥ 3x ULN occurred in 0.7 % (7/935) of Vimpat patients and 0 % (0/356) of placebo patients.
Slovenian: Povišane vrednosti ALT na ≥ 3x zgornjo mejo normalnih vrednosti (ULN- upper limit of normal), so se pojavile pri 0,7 % (7/935) bolnikov, ki so jemali zdravilo Vimpat, in pri 0 % (0/356) bolnikov, ki so jemali placebo.
English: Vimpat contains sorbitol, sodium, sodium methyl parahydroxybenzoate, aspartame and propylene glycol
Slovenian: Zdravilo Vimpat vsebuje sorbitol, natrij, natrijev metilparahidroksibenzoat, aspartam in propilenglikol
English: Vimpat 10 mg/ml syrup is a slightly viscous clear, colourless to yellow-brown liquid.
Slovenian: • Zdravilo Vimpat 10 mg/ml sirup je rahlo viskozna, bistra tekočina brezbarvne do rumeno-rjave barve.
English: Aesica Pharmaceuticals GmbH, Alfred-Nobel Strasse 10, D-40789 Monheim am Rhein, Germany or
Slovenian: Aesica Pharmaceuticals GmbH, Alfred-Nobel Strasse 10, D-40789 Monheim am Rhein, Nemčija ali
English: Vimpat syrup contains 1.42 mg sodium per ml, equivalent to 0.07 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Slovenian: Zdravilo Vimpat sirup vsebuje 1,42 mg natrija na ml, kar je enako 0,07 % največjega dnevnega vnosa natrija za odrasle osebe, ki ga priporoča SZO in znaša 2 g.
English: Each vial of Vimpat solution for infusion must be used only once (single use).
Slovenian: Vsaka viala zdravila Vimpat 10 mg/ml raztopina za infundiranje se lahko uporabi le enkrat (enkratna uporaba).
English: Instructions for use: oral syringe
Slovenian: Navodila za uporabo: merica
English: Each ml of Vimpat syrup contains 187 mg sorbitol (E420), 2.60 mg sodium methyl parahydroxybenzoate (E219), 2.14 mg propylene glycol (E1520), 1.42 mg sodium, and 0.032 mg aspartame (E951).
Slovenian: En ml sirupa zdravila Vimpat vsebuje 187 mg sorbitola (E420), 2,60 mg natrijevega metilparahidroksibenzoata (E219), 2,14 mg propilenglikola (E1520), 1,42 mg natrija in 0,032 mg aspartama (E951).
English: During the second week, the patient takes Vimpat 100 mg tablets twice a day.
Slovenian: V drugem tednu jemlje bolnik zdravilo Vimpat 100 mg tablete dvakrat na dan.
English: Outer carton - treatment initiation pack containing 4 cartons of 14 film-coated tablets
Slovenian: SAMO ZA PAKIRANJE ZA ZAČETEK ZDRAVLJENJA Zunanja škatla - pakiranje za začetek zdravljenja vsebuje 4 škatle po 14 filmsko obloženih tablet
English: Put the oral syringe into the adaptor opening (figure 4).
Slovenian: • brizgo za peroralno odmerjanje vstavite v odprtino nastavka (slika 4);
English: It is not recommended to use Vimpat if you are pregnant or breast feeding, as the effects of Vimpat on pregnancy and the unborn baby or the new-born child are not known.
Slovenian: V času nosečnosti ali dojenja uporaba zdravila Vimpat ni priporočljivo, ker učinki zdravila Vimpat na nosečnost, nerojenega ali novorojenega otroka niso znani.
English: The carton boxes of Vimpat syrup contain a 30 ml measuring cup with graduation marks and a 10 ml oral syringe.
Slovenian: Škatle sirupa zdravila Vimpat vsebujejo 30-ml merico z graduacijskimi oznakami in 10-ml brizgo za peroralno odmerjanje.
English: This leaflet was last revised in {month/YYYY}.
Slovenian: Navodilo je bilo nazadnje revidirano dne {mesec LLLL} Drugi viri informacij
English: Depending on response and tolerability, Vimpat 150 mg tablets may be taken twice a day during the third week and Vimpat 200 mg tablets twice a day during the fourth week.
Slovenian: Glede na odziv in prenašanje, lahko bolnik zdravilo Vimpat 150 mg tablete v tretjem tednu jemlje dvakrat na dan in v četrtem tednu zdravilo Vimpat 200 mg tablete dvakrat na dan.
English: It is not recommended to take Vimpat if you are pregnant or breast-feeding, as the effects of Vimpat on pregnancy and the unborn baby or the new-born child are not known.
Slovenian: V času nosečnosti ali dojenja jemanje zdravila Vimpat ni priporočljivo, ker učinki zdravila Vimpat na nosečnost, nerojenega ali novorojenega otroka niso znani.
English: Listed below are the normal recommended doses of Vimpat for different age groups and weights.
Slovenian: Spodaj so navedeni običajni priporočeni odmerki zdravila Vimpat za različne starostne skupine in telesne mase.
English: Using Vimpat on its own - This is for information only.
Slovenian: Samostojna uporaba zdravila Vimpat - to navodilo je le informativno.
English: When you take Vimpat on its own
Slovenian: Ko boste vzeli zdravilo Vimpat samostojno
English: If you have taken more Vimpat than you should, contact your doctor immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Vimpat, kot bi smeli Če ste vzeli večji odmerek zdravila Vimpat, kot bi smeli, se takoj posvetujte z zdravnikom.
English: It is used to treat a certain type of epilepsy characterised by the occurrence of partial-onset seizure with or without secondary generalisation.
Slovenian: • Zdravilo Vimpat se uporablja za zdravljenje določene vrste epilepsije, za katero so značilni parcialni napadi s sekundarno generalizacijo ali brez nje.
English: They will help you decide if you should take Vimpat or not.
Slovenian: Pomagal vam bo pri odločitvi, ali smete jemati zdravilo Vimpat ali ne.
English: If you stop using Vimpat
Slovenian: Če ste prenehali uporabljati zdravilo Vimpat
English: There is experience with twice daily infusions of Vimpat for up to 5 days.
Slovenian: Po izkušnjah se infuzije zdravila Vimpat dajejo dvakrat dnevno do 5 dni.
English: Take Vimpat twice each day - once in the morning and once in the evening.
Slovenian: • Zdravilo Vimpat vzemite vsak dan dvakrat, enkrat zjutraj in enkrat zvečer.
English: UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium.
Slovenian: Imetnik dovoljenja za promet z zdravilom UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgija.
English: Vimpat can be started by: - taking the medicine by mouth or - by being given as an intravenous infusion (sometimes called an “IV infusion”) where the medicine is given into your vein by a doctor or nurse.
Slovenian: • Zdravljenje z zdravilom Vimpat lahko začnemo: o Z jemanjem skozi usta ali o s prejemanjem intravenske infuzije (včasih imenovane »i.v.
English: • Vimpat is used in adolescents and children aged 4 years and older weighing 50 kg or more and in adults.
Slovenian: • Zdravilo Vimpat se uporablja pri mladostnikih in otrocih, starih 4 leta ali več, ki tehtajo 50 kg ali več, in pri odraslih.
English: If you weigh 50 kg or more, your doctor may decide to start Vimpat treatment with a single “loading” dose of 200 mg (20 ml).
Slovenian: Če tehtate 50 kg ali več, se lahko zdravnik odloči, da začne zdravljenje z zdravilom Vimpat z enkratnim začetnim »polnilnim« odmerkom 200 mg (20 ml).
English: Vimpat is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.
Slovenian: Zdravilo Vimpat je indicirano za samostojno in dopolnilno zdravljenje parcialnih napadov s sekundarno generalizacijo ali brez nje pri odraslih, mladostnikih in otrocih od 4. leta starosti z epilepsijo.
English: Justification for not including Braille accepted.
Slovenian: PODATKI V BRAILLOVI PISAVI Sprejeta obrazložitev glede neuporabe Braillove pisave.
English: Contains sorbitol (E420), sodium methyl parahydroxybenzoate (E219), propylene glycol (E1520), sodium and aspartame (E951).
Slovenian: Vsebuje sorbitol (E420), natrijev metilparahidroksibenzoat (E219), propilenglikol (E1520), natrij in aspartam (E951).
English: Vimpat syrup contains propylene glycol (E1520).
Slovenian: Zdravilo Vimat sirup vsebuje propilenglikol (E1520).
English: What Vimpat is and what it is used for What Vimpat is
Slovenian: Kaj je zdravilo Vimpat in za kaj ga uporabljamo
English: 14 film-coated tablets 56 film-coated tablets 168 film-coated tablets 56 x 1 film-coated tablet 14 x 1 film-coated tablet 28 film-coated tablets 60 film-coated tablets
Slovenian: 14 filmsko obloženih tablet 56 filmsko obloženih tablet 168 filmsko obloženih tablet 56 x 1 filmsko obložena tableta 14 x 1 filmsko obložena tableta 28 filmsko obloženih tablet 60 filmsko obloženih tablet
English: If you stop taking Vimpat
Slovenian: Če ste prenehali jemati zdravilo Vimpat
English: Children and adolescents weighing less than 50 kg
Slovenian: Otroci in mladostniki, ki tehtajo manj kot 50 kg
English: Fall Skin laceration Contusion (1) Adverse reactions reported in post marketing experience.
Slovenian: Poškodbe, zastrupitve in zapleti pri posegih padec kožna laceracija kontuzija (1) Neželeni učinki o katerih so poročali v obdobju trženja.
English: Use the oral syringe and the adaptor provided in this pack.
Slovenian: • Uporabite brizgo za peroralno odmerjanje in nastavek, ki sta priložena temu pakiranju.
English: The 14 x 1 and 56 x 1 film-coated tablet packs are available as perforated unit dose PVC/PVDC blisters sealed with an aluminium foil, the 14, 28, 56 and 168 packs are available with standard PVC/PVDC blisters sealed with an aluminium foil, the 60 packs are available in HDPE bottles with a child-resistant closure.
Slovenian: Pakiranji 14 x 1 in 56 x 1 filmsko obložena tableta sta na voljo v PVC/PVDC perforiranih pretisnih omotih za posamezni odmerek, pokritih z aluminijasto folijo, pakiranja po 14, 28, 56 in 168 v standardnih PVC/PVDC pretisnih omotih, pokritih z aluminijasto folijo, pakiranja po 60 so na voljo v plastenkah iz polietilena visoke gostote (HDPE) z za otroke varno zaporko.
English: 14 film-coated tablets 56 film-coated tablets 56 x 1 film-coated tablet 14 x 1 film-coated tablet 28 film-coated tablets 60 film-coated tablets
Slovenian: 14 filmsko obloženih tablet 56 filmsko obloženih tablet 56 x 1 filmsko obložena tableta 14 x 1 filmsko obložena tableta 28 filmsko obloženih tablet 60 filmsko obloženih tablet
English: On the first day of treatment the patient starts with Vimpat 50 mg tablets twice a day.
Slovenian: Prvi dan zdravljenja začne bolnik z zdravilom Vimpat 50 mg tablete dvakrat na dan.
English: Vimpat 50 mg and Vimpat 100 mg are available in packs of 168 film-coated tablets and Vimpat 150 mg and Vimpat 200 mg are available in multipacks comprising 3 cartons, each containing 56 tablets.
Slovenian: Zdravili Vimpat 50 mg in Vimpat 100 mg sta na voljo v pakiranjih po 168 filmsko obloženih tablet, zdravili Vimpat 150 mg in Vimpat 200 mg pa sta na voljo v skupnem pakiranju, ki vsebuje 3 škatle s po 56 tabletami.
English: Vimpat solution for infusion is available in packages of 1 vial and 5 vials.
Slovenian: Zdravilo Vimpat 10 mg/ml raztopina za infundiranje je na voljo v pakiranjih po 1 vialo in po 5 vial.
English: The treatment initiation pack contains 4 cartons, each carton with 14 Vimpat film-coated tablets of 50 mg, 100 mg, 150 mg and 200 mg.
Slovenian: Vsaka škatla zdravila Vimpat ima 14 filmsko obloženih tablet po 50 mg, 100 mg, 150 mg in 200 mg.
English: UCB Pharma SA/NV Tél/Tel: + 32 / (0)2 559 92 00
Slovenian: Luxembourg/Luxemburg UCB Pharma SA/NV Tél/Tel: + 32 / (0)2 559 92 00
English: Use Vimpat twice each day - once in the morning and once in the evening.
Slovenian: • Zdravilo Vimpat boste prejeli dvakrat na dan - enkrat zjutraj in enkrat zvečer.
English: Follow these steps the first time you take Vimpat:
Slovenian: Pri prvi uporabi zdravila Vimpat izvedite te korake:
English: As a safety precaution do not take Vimpat with alcohol.
Slovenian: Zdravilo Vimpat skupaj z alkoholom Iz varnostnih razlogov ne jemljite zdravila Vimpat skupaj z alkoholom.
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: Each pack of 56 film-coated tablets for a 4-week treatment schedule contains: 14 film-coated tablets of Vimpat 50 mg 14 film-coated tablets of Vimpat 100 mg 14 film-coated tablets of Vimpat 150 mg 14 film-coated tablets of Vimpat 200 mg
Slovenian: Vsako pakiranje s 56 filmsko obloženimi tabletami za 4-tedensko zdravljenje vsebuje: 14 filmsko obloženih tablet zdravila Vimpat 50 mg 14 filmsko obloženih tablet zdravila Vimpat 100 mg 14 filmsko obloženih tablet zdravila Vimpat 150 mg 14 filmsko obloženih tablet zdravila Vimpat 200 mg
English: How to use Vimpat
Slovenian: Kako uporabljati zdravilo Vimpat
English: Packs of 60 film-coated tablets in HDPE bottle with a child-resistant closure.
Slovenian: Pakiranje po 60 filmsko obloženih tablet v plastenki iz polietilena visoke gostote (HDPE) z za otroke varno zaporko.
English: Vimpat is available in a bottle of 200 ml.
Slovenian: • Zdravilo Vimpat je na voljo v steklenicah po 200 ml.
English: What Vimpat is and what it is used for What you need to know before you use Vimpat How to use Vimpat
Slovenian: Kaj je zdravilo Vimpat in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Vimpat Kako uporabljati zdravilo Vimpat Možni neželeni učinki
English: As a safety precaution do not use Vimpat with alcohol.
Slovenian: Zdravilo Vimpat skupaj z alkoholom Iz varnostnih razlogov ne uporabljajte zdravila Vimpat skupaj z alkoholom.