FrancophonIA/ELRC3.0 huggingface dataset:
English: Yellow, 16 mm oblong, scored and debossed with the code “ucb” and “500” on one side.
Slovenian: Rumena, 16 mm podolgovata tableta z zarezo, z vtisnjenima oznakama “ucb” in “500” na eni strani.
English: 28 mg (0.3 ml) twice daily 84 mg (0.85 ml) twice daily
Slovenian: 84 mg (0,85 ml) dvakrat na dan
English: Keppra 250 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Keppra 250 mg
English: Keppra 500 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Keppra 500 mg
English: Name and address of the manufacturers responsible for batch release
Slovenian: A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ Ime in naslov izdelovalcev, odgovornih za sproščanje serij Filmsko obložene tablete
English: Box of 200 (2 x 100) containing blue box
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla z 200 (2 x 100) tabletami, ki vsebuje modro okence
English: Sodium acetate Glacial acetic acid Sodium chloride Water for injections
Slovenian: 6.1 Seznam pomožnih snovi natrijev acetat koncentrirana ocetna kislina natrijev klorid voda za injekcije
English: Starting dose: 0.07 ml/kg twice daily Maximum dose: 0.21 ml/kg twice daily
Slovenian: telesna masa začetni odmerek: 7 mg/kg dvakrat na dan največji odmerek: 21 mg/kg dvakrat na dan
English: 49 mg (0.5 ml)twice daily 147 mg (1.5 ml) twice daily
Slovenian: 147 mg (1,5 ml) dvakrat na dan
English: Suicide attempt, suicidal ideation, psychotic disorder, abnormal behaviour, hallucination, anger, confusional state , panic attack, affect lability/mood swings, agitation
Slovenian: Psihiatrične motnje depresija, sovražnost/ agresivnost, anksioznost, nespečnost, živčnost/razdražljivost poskus samomora, razmišljanje o samomoru, psihotične motnje, nenormalno vedenje, halucinacije, jeza, stanje zmedenosti, napad panike, čustvena labilnost/nihanja v razpoloženju, agitacija samomor, osebnostne motnje, motnje mišljenja, delirij
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: Linear and dose proportional increases were observed for peak plasma concentration and area under the curve.
Slovenian: Pri najvišji plazemski koncentraciji in površini pod krivuljo so opazili linearno in odmerku sorazmerno povečanje.
English: EU/1/00/146/019 100 tablets
Slovenian: EU/1/00/146/019 100 tablet
English: Polyvinyl alcohol-part. hydrolyzed Titanium dioxide (E171) Macrogol 3350
Slovenian: Filmska obloga: delno hidroliziran polivinilalkohol titanov dioksid (E171) makrogol 3350 smukec
English: Do not use this medicine after the expiry date stated on the cardboard box and bottle after EXP: The expiry date refers to the last day of the month.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in steklenici poleg oznake EXP.
English: Children and adolescents • Keppra is not indicated in children and adolescents below 16 years on it's own (monotherapy)
Slovenian: • zdravilo Keppra, pri otrocih in mladostnikih, mlajših od 16 let, ni indicirano za samostojno zdravljenje (monoterapija)
English: The safety and efficacy of Keppra in children and adolescents below 16 years as monotherapy treatment have not been established.
Slovenian: Pri samostojnem zdravljenju pri otrocih in mladostnikih, mlajših od 16 let, varnost in učinkovitost zdravila Keppra nista bili dokazani.
English: EU/1/00/146/021 EU/1/00/146/022 EU/1/00/146/023 EU/1/00/146/024 EU/1/00/146/025 EU/1/00/146/026 EU/1/00/146/037
Slovenian: EU/1/00/146/023 EU/1/00/146/024 EU/1/00/146/025 EU/1/00/146/026 EU/1/00/146/037
English: 300 ml amber glass bottle (type III) with a white child resistant closure (polypropylene) in a cardboard box also containing a 10 ml graduated oral syringe (polypropylene, polyethylene) and an adaptor for the syringe (polyethylene).
Slovenian: 300 ml steklenica (tip III) jantarne barve z belo zaporko, varno za otroke (polipropilen) v škatli, ki vsebuje še 10 ml graduirano brizgo za peroralno dajanje (polipropilen, polietilen) in adapter za brizgo (polietilen).
English: A 15 mg/kg (0.15 ml/kg) loading dose is recommended on the first day of treatment with levetiracetam.
Slovenian: (1) Prvi dan zdravljenja z levetiracetamom je priporočen začetni odmerek 15 mg/kg (0,15 ml/kg).
English: Box of 200 (2 x 100) with blue box
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla z 200 (2 x 100) tabletami z modrim okencem
English: EU/1/00/146/018 80 tablets
Slovenian: EU/1/00/146/018 80 tablet
English: Keppra 1000 mg film-coated tablets Levetiracetam
Slovenian: Keppra 1000 mg filmsko obložene tablete levetiracetam
English: Keppra 100 mg/ml oral solution
Slovenian: IME ZDRAVILA Keppra 100 mg/ml peroralna raztopina
English: 150 ml amber glass bottle (type III) with a white child resistant closure (polypropylene) in a cardboard box also containing a 1 ml graduated oral syringe (polypropylene, polyethylene) and an adaptor for the syringe (polyethylene).
Slovenian: 150 ml steklenica (tip III) jantarne barve z belo zaporko, varno za otroke (polipropilen) v škatli, ki vsebuje še 1 ml graduirano brizgo za peroralno dajanje (polipropilen, polietilen) in adapter za brizgo (polietilen).
English: 150 ml amber glass bottle (type III) with a white child resistant closure (polypropylene) in a cardboard box also containing a 3 ml graduated oral syringe (polypropylene, polyethylene) and an adaptor for the syringe (polyethylene).
Slovenian: 150 ml steklenica (tip III) jantarne barve z belo zaporko, varno za otroke (polipropilen) v škatli, ki vsebuje še 3 ml graduirano brizgo za peroralno dajanje (polipropilen, polietilen) in adapter za brizgo (polietilen).
English: Keppra oral solution should be used for doses under 250 mg, for doses not multiple of 250 mg when dosing recommendation is not achievable by taking multiple tablets and for patients unable to swallow tablets.
Slovenian: (1) Pri odmerkih, manjših od 250 mg, pri odmerkih, ki niso večkratniki od 250 mg in se priporočenega odmerjanja zato ne more doseči z večimi tabletami in pri bolnikih, ki ne morejo požirati tablet, je treba uporabiti zdravilo Keppra peroralna raztopina.
English: EU/1/00/146/025 100 tablets
Slovenian: EU/1/00/146/025 100 tablet
English: EU/1/00/146/022 30 tablets
Slovenian: EU/1/00/146/022 30 tablet
English: EU/1/00/146/015 30 tablets
Slovenian: EU/1/00/146/015 30 tablet
English: EU/1/00/146/017 60 tablets
Slovenian: EU/1/00/146/017 60 tablet
English: EU/1/00/146/024 60 tablets
Slovenian: EU/1/00/146/024 60 tablet
English: EU/1/00/146/023 50 tablets
Slovenian: EU/1/00/146/023 50 tablet
English: What Keppra looks like and contents of the pack Keppra 250 mg film-coated tablets are blue, 13 mm oblong, scored and debossed with the code “ucb” and “250” on one side.
Slovenian: Zdravilo Keppra 250 mg filmsko obložene tablete so modre, 13 mm podolgovate, z zarezo in imajo na eni strani vtisnjeni oznaki »ucb« in »250«.
English: Your doctor will prescribe the most appropriate pharmaceutical form of Keppra according to the age, weight and dose.
Slovenian: Odmerjanje pri otrocih, starih 6 mesecev in starejših Zdravnik bo glede na starost, telesno maso in odmerek predpisal najprimernejšo farmacevtsko obliko zdravila Keppra.
English: 35 mg (0.35 ml) twice daily 105 mg (1.05 ml) twice daily
Slovenian: 105 mg (1,05 ml) dvakrat na dan
English: Aesica Pharmaceuticals S.r.l., Via Praglia 15, I-10044 Pianezza, Italy
Slovenian: UCB Pharma SA, Chemin du Foriest, B-1420 Braine-l'Alleud, Belgija ali Aesica Pharmaceuticals S.r.l., Via Praglia 15, I-10044 Pianezza, Italija
English: • in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents, children and infants from 1 month of age with epilepsy.
Slovenian: • parcialnih napadov s sekundarno generalizacijo ali brez nje pri odraslih, mladostnikih, otrocih in dojenčkih, od 1 meseca starosti, z epilepsijo
English: Children 25 kg or less should preferably start the treatment with Keppra 100 mg/ml oral solution.
Slovenian: 1500 mg dvakrat na dan (1) Pri otrocih, težkih 25 kg ali manj, je bolje začeti zdravljenje z zdravilom Keppra 100 mg/ml peroralna raztopina.
English: 150 mg (1.5 ml) twice daily 450 mg (4.5 ml) twice daily
Slovenian: 150 mg (1,5 ml) dvakrat na dan
English: Sunset Yellow FCF (E110) colouring agent may cause allergic reactions.
Slovenian: Zdravilo Keppra 750 mg tablete vsebuje barvilo sončno rumeno FCF (E110) Barvilo sončno rumeno FCF (E110) lahko povzroči alergijske reakcije.
English: Keppra 750 mg film-coated tablets Levetiracetam
Slovenian: Keppra 750 mg filmsko obložene tablete levetiracetam
English: Do not use this medicine after the expiry date stated on the vial and carton box after EXP: The expiry date refers to the last day of the month.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in škatli poleg oznake EXP.
English: Measure the appropriate dosage using the 10 ml syringe included in the package for patients 4 years and above.
Slovenian: Odmerjanje pri odraslih in mladostnikih (od 16. leta starosti) Ustrezen odmerek izmerite z uporabo 10 ml brizge, ki je priložena k zdravilu za bolnike, stare 4 leta in več.
English: EU/1/00/146/016 50 tablets
Slovenian: EU/1/00/146/016 50 tablet
English: Each film-coated tablet contains 1,000 mg levetiracetam.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 1000 mg levetiracetama.
English: Adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents, children and infants from 1 month of age with epilepsy.
Slovenian: Dopolnilno zdravljenje parcialnih napadov s sekundarno generalizacijo ali brez nje pri odraslih, mladostnikih, otrocih in dojenčkih od 1 meseca starosti, z epilepsijo
English: EU/1/00/146/020 10 tablets
Slovenian: EU/1/00/146/020 10 tablet
English: Contact your doctor if you have missed one or more doses.
Slovenian: Če ste pozabili vzeti enega ali več odmerkov, se posvetujte s svojim zdravnikom.
English: Following dialysis, a 250 to 500 mg supplemental dose is recommended.
Slovenian: (1) Prvi dan zdravljenja z levetiracetamom je priporočljiv začetni odmerek 750 mg. (2) Po dializi je priporočljiv dodatni odmerek od 250 do 500 mg.
English: Keppra 250 mg film-coated tablets Levetiracetam
Slovenian: Keppra 250 mg filmsko obložene tablete levetiracetam
English: Suicide, suicide attempt, suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents (including levetiracetam.
Slovenian: Pri bolnikih, ki so se zdravili z antiepileptiki (vključno z levetiracetamom), so poročali o samomoru, poskusu samomora, samomorilnem razmišljanju in vedenju.
English: Keppra 500 mg film-coated tablets Levetiracetam
Slovenian: Keppra 500 mg filmsko obložene tablete levetiracetam
English: (see table below for dose examples).
Slovenian: (navedeno v poglavju 6).
English: 200 mg (2 ml) twice daily 600 mg (6 ml) twice daily
Slovenian: 600 mg (6 ml) dvakrat na dan
English: • 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: • parcialnih napadov s sekundarno generalizacijo ali brez nje pri odraslih, mladostnikih in otrocih, od 4. leta starosti, z epilepsijo
English: EU/1/00/146/021 20 tablets
Slovenian: EU/1/00/146/021 20 tablet
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 500 mg/5 ml
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA intravenska uporaba
English: Keppra 1000 mg film-coated tablets
Slovenian: IME ZDRAVILA Keppra 1000 mg filmsko obložene tablete
English: Keppra 750 mg film-coated tablets
Slovenian: IME ZDRAVILA Keppra 750 mg filmsko obložene tablete
English: A 10.5 mg/kg (0.105 ml/kg) loading dose is recommended on the first day of treatment with levetiracetam.
Slovenian: (2) Prvi dan zdravljenja z levetiracetamom je priporočljiv začetni odmerek 10,5 mg/kg (0,105 ml/kg).
English: Starting dose: 0.1 ml/kg twice daily Maximum dose: 0.3 ml/kg twice daily
Slovenian: Odmerjanje pri otrocih, starih 6 mesecev in starejših: telesna masa začetni odmerek: 0,1 ml/kg dvakrat na dan največji odmerek: 0,3 ml/kg dvakrat na dan
English: Keppra 100 mg/ml oral solution is a formulation more appropriate to infants and children under the age of 6 years and to children and adolescent (from 6 to 17 years) weighing less than 50kg and when tablets don't allow accurate dosage.
Slovenian: Za dojenčke in otroke, mlajše od 6 let, za otroke in mladostnike (od 6 do 17 let), lažjih od 50 kg in kadar s tabletami ne moremo zagotoviti natančnega odmerjanja, je zdravilo Keppra 100 mg/ml peroralna raztopina primernejša farmacevtska oblika.
English: 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: Dopolnilno zdravljenje parcialnih napadov s sekundarno generalizacijo ali brez nje pri odraslih, mladostnikih in otrocih, od 4. leta starosti, z epilepsijo
English: Contact your doctor if you took more Keppra than you should.
Slovenian: Če ste vzeli več zdravila Keppra kot bi morali, se posvetujte s svojim zdravnikom.
English: 500 mg/5 ml
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 500 mg/5 ml
English: 100 mg (1 ml) twice daily 300 mg (3 ml) twice daily
Slovenian: 300 mg (3 ml) dvakrat na dan
English: EU/1/00/146/014 20 tablets
Slovenian: EU/1/00/146/014 20 tablet
English: UCB Pharma SA Allée de la Recherche 60 B-1070 Brussels Belgium
Slovenian: UCB Pharma SA Allée de la Recherche 60 B-1070 Brussels Belgija
English: UCB Pharma SA Allée de la Recherche 60 B-1070 Brussels BELGIUM
Slovenian: UCB Pharma SA Allée de la Recherche 60 B-1070 Brussels BELGIJA
English: 7 to 14 mg/kg (0.07 to 0.14 ml/kg) once daily
Slovenian: 7 do 14 mg/kg (0,07 do 0,14 ml/kg) enkrat na dan(2)(4)
English: Suicide, suicide attempt, suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents (including levetiracetam).
Slovenian: Pri bolnikih, ki so se zdravili z antileptiki (vključno z levetiracetamom), so poročali o samomoru, poskusu samomora, samomorilnem razmišljanju in vedenju.
English: • 500 mg: 10, 20, 30, 50, 60, 100 x 1, 100, 120 film-coated tablets and multipacks containing 200 (2 packs of 100) film-coated tablets
Slovenian: • 500 mg: 10, 20, 30, 50, 60, 100 x 1, 100, 120 filmsko obloženih tablet in v večkratnem pakiranju po 200 (2 pakiranji po 100) filmsko obloženih tablet.
English: Keppra 250 mg film-coated tablets
Slovenian: IME ZDRAVILA Keppra 250 mg filmsko obložene tablete
English: • 750 mg: 20, 30, 50, 60, 80, 100 x 1, 100 film-coated tablets and multipacks containing 200 (2 packs of 100) film-coated tablets
Slovenian: • 750 mg: 20, 30, 50, 60, 80, 100 x 1, 100 filmsko obloženih tablet in v večkratnem pakiranju po 200 (2 pakiranji po 100) filmsko obloženih tablet.
English: • 1000 mg: 10, 20, 30, 50, 60, 100 x 1, 100 film-coated tablets and multipacks containing 200 (2 packs of 100) film-coated tablets
Slovenian: • 1000 mg: 10, 20, 30, 50, 60, 100 x 1, 100 filmsko obloženih tablet in v večkratnem pakiranju po 200 (2 pakiranji po 100) filmsko obloženih tablet.
English: 10 to 20 mg/kg (0.10 to 0.20 ml/kg) once daily
Slovenian: 10 do 20 mg/kg (0,10 do 0,20 ml/kg) enkrat na dan(1)(2)
English: Box of 10, 20, 30, 50, 60, 100, 100 (100 x 1), 120
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla z 10, 20, 30, 50, 60, 100, 100 (100 x 1), 120 tabletami
English: Magnesium stearate
Slovenian: • vnetje trebušne slinavke
English: Each film-coated tablet contains 250 mg levetiracetam.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 250 mg levetiracetama.
English: Keppra 1000 mg Justification for not including Braille accepted 100 x 1 tablets
Slovenian: Odobrena razlaga, da Braillova pisava ni potrebna 100 x 1 tableta
English: One vial contains 500 mg/5 ml levetiracetam.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena viala vsebuje 500 mg/5 ml levetiracetama.
English: Keppra 500 mg film-coated tablets
Slovenian: IME ZDRAVILA Keppra 500 mg filmsko obložene tablete
English: Each film-coated tablet contains 750 mg levetiracetam.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 750 mg levetiracetama.
English: Silica colloidal anhydrous Magnesium stearate
Slovenian: Jedro tablete: premreženi natrijev karmelozat makrogol 6000 brezvodni koloidni silicijev dioksid magnezijev stearat
English: Justification for not including Braille accepted
Slovenian: PODATKI V BRAILLOVI PISAVI Odobrena razlaga, da Braillova pisava ni potrebna.
English: • as an add-on to other antiepileptic medicines to treat: ▪ partial onset seizures with or without generalisation in in adults, adolescents and children from 4 years of age ▪ myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy.
Slovenian: • kot dopolnilo drugim protiepileptičnim zdravilom za zdravljenje: ▪ parcialnih napadov z generalizacijo ali brez nje pri odraslih, mladostnikih in otrocih od 4. leta starosti ▪ miokloničnih napadov (kratki, nenadni trzaji mišice ali skupine mišic) pri odraslih in mladostnikih od 12. leta starosti z juvenilno mioklonično epilepsijo ▪ primarno generaliziranih tonično-kloničnih napadov (veliki napadi, vključno z izgubo zavesti) pri odraslih in mladostnikih od 12. leta starosti z idiopatsko generalizirano epilepsijo (oblika epilepsije, za katero se domneva, da je genetskega izvora).
English: Each film-coated tablet contains 500 mg levetiracetam.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 500 mg levetiracetama.
English: Aluminium/PVC blisters placed into cardboard boxes containing 10, 20, 30, 50, 60, 100, 120 filmcoated tablets and multipacks containing 200 (2 packs of 100) film-coated tablets.
Slovenian: Aluminij/PVC pretisni omoti, v škatlah po 10, 20, 30, 50, 60, 100, 120 filmsko obloženih tablet in v večkratnem pakiranju po 200 (dve pakiranji po 100) filmsko obloženih tablet.
English: Keppra oral solution is the preferred formulation for use in this population.
Slovenian: Pri tej populaciji je najprimernejša farmacevtska oblika za uporabo zdravilo Keppra peroralna raztopina.
English: Keppra 100 mg/ml only for the outer carton
Slovenian: PODATKI V BRAILLOVI PISAVI Keppra 100 mg/ml (samo za škatlo)
English: 10 film-coated tablets 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 100 film-coated tablets 100 x 1 film-coated tablets 120 film-coated tablets
Slovenian: 10 filmsko obloženih tablet 20 filmsko obloženih tablet 30 filmsko obloženih tablet 50 filmsko obloženih tablet 60 filmsko obloženih tablet 100 filmsko obloženih tablet 100 x 1 filmsko obložena tableta 120 filmsko obloženih tablet
English: Box of 20, 30, 50, 60, 80, 100, 100 (100 x 1)
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla z 20, 30, 50, 60, 80, 100, 100 (100 x 1) tabletami
English: Aluminium/PVC blisters placed into cardboard boxes containing 20, 30, 50, 60, 80, 100 film-coated tablets and multipacks containing 200 (2 packs of 100) film-coated tablets.
Slovenian: Aluminij/PVC pretisni omoti, v škatlah po 20, 30, 50, 60, 80, 100 filmsko obloženih tablet in v večkratnem pakiranju po 200 (dve pakiranji po 100) filmsko obloženih tablet.
English: Suicide attempt, suicidal ideation, psychotic disorder, abnormal behaviour, hallucination, anger, confusional state , panic attack, affect lability/mood swings, agitation,
Slovenian: Bolezni živčevja somnolenca, glavobol konvulzije, motnje ravnotežja, omotica, letargija, tremor amnezija, oslabljen spomin, poslabšana koordinacija/ataksija, parestezija, motnje pozornosti horeoatetoza, diskinezija, hiperkinezija, motnje hoje, encefalopatija
English: Oral solution.
Slovenian: − Navodilo shranite.
English: 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 80 film-coated tablets 100 film-coated tablets 100 x 1 film-coated tablets
Slovenian: 20 filmsko obloženih tablet 30 filmsko obloženih tablet 50 filmsko obloženih tablet 60 filmsko obloženih tablet 80 filmsko obloženih tablet 100 filmsko obloženih tablet 100 x 1 filmsko obložena tableta
English: 10 film-coated tablets 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 100 film-coated tablets 100 x 1 film-coated tablets
Slovenian: 10 filmsko obloženih tablet 20 filmsko obloženih tablet 30 filmsko obloženih tablet 50 filmsko obloženih tablet 60 filmsko obloženih tablet 100 filmsko obloženih tablet 100 x 1 filmsko obložena tableta
English: Box of 10, 20, 30, 50, 60, 100, 100 (100 x 1)
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla z 10, 20, 30, 50, 60, 100, 100 (100 x 1) tabletami
English: 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 100 film-coated tablets 100 x 1 film-coated tablets
Slovenian: 20 filmsko obloženih tablet 30 filmsko obloženih tablet 50 filmsko obloženih tablet 60 filmsko obloženih tablet 100 filmsko obloženih tablet 100 x 1 filmsko obložena tableta
English: Aluminium/PVC blisters placed into cardboard boxes containing 10, 20, 30, 50, 60, 100 film-coated tablets and multipacks containing 200 (2 packs of 100) film-coated tablets.
Slovenian: Aluminij/PVC pretisni omoti, v škatlah po 10, 20, 30, 50, 60, 100 filmsko obloženih tablet in v večkratnem pakiranju po 200 (dve pakiranji po 100) filmsko obloženih tablet.
English: Keppra 100 mg/ml sterile concentrate Levetiracetam
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Keppra 100 mg/ml sterilni koncentrat levetiracetam i.v.
English: Pancytopenia, neutropenia, agranulocytosis
Slovenian: Bolezni krvi in limfatičnega sistema trombocitopenija levkopenija pancitopenija, nevtropenija, agranulocitoza
English: Aluminium/PVC blisters placed into cardboard boxes containing 20, 30, 50, 60, 100 film-coated tablets and multipacks containing 200 (2 packs of 100) film-coated tablets.
Slovenian: Aluminij/PVC pretisni omoti, v škatlah po 20, 30, 50, 60, 100 filmsko obloženih tablet in v večkratnem pakiranju po 200 (dve pakiranji po 100) filmsko obloženih tablet.
English: Bottle of 300 ml
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI Steklenica s 300 ml raztopine
English: 100 film-coated tablets Component of a multipack, can't be sold separately.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 100 filmsko obloženih tablet Del skupnega pakiranja.
English: • 250 mg: 20, 30, 50, 60, 100 x 1, 100 film-coated tablets and multipacks containing 200 (2 packs of 100) film-coated tablets
Slovenian: • 250 mg: 20, 30, 50, 60, 100 x 1, 100 filmsko obloženih tablet in v večkratnem pakiranju po 200
English: Keppra 750 mg Justification for not including Braille accepted 100 x 1 tablets
Slovenian: Odobrena razlaga, da Braillova pisava ni potrebna 100 x 1 tableta 17.
English: EU/1/17/1238/001 Nyxoid
Slovenian: EU/1/17/1238/001
English: 2 spray containers
Slovenian: 2 Obaly na sprej
English: 1.8 mg Nasal spray, solution Nasal use vial (glass)
Slovenian: 1,8 mg Pršilo za nos, raztopina
English: Pack size
Slovenian: Nyxoid
English: London, June 2008 EMEA/532160/2007 - Rev.1
Slovenian: London, junij 2008 EMEA/532160/2007 - Rev.1
English: Belgium and Norway could not agree with granting a marketing authorisation.
Slovenian: Belgija in Norveška se nista strinjali z odobritvijo dovoljenja za promet z zdravilom.
English: They considered the product to present a potential serious risk for animal health.
Slovenian: Menili sta, da zdravilo pomeni možno resno tveganje za zdravje živali.
English: The CVMP during its meeting of 14-16 March 2006 started a referral procedure under Article 33(4) of Directive 2001/82/EC, as amended.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini je na zasedanju od 14. do 16. marca 2006 sprožil napotitveni postopek v skladu s členom 33(4) Direktive 2001/82/ES, kakor je bila spremenjena.