natgillin/translations-raw huggingface dataset:
Eslicarbazepine acetate 800 mg once daily and 1,200 mg once daily were significantly more effective than placebo in reducing seizure frequency over a 12-week maintenance period.
400 mg (samo v študijah 301 in 302), 800 mg in 1.200 mg enkrat na dan. Eslikarbazepinacetat pri odmerku 800 mg enkrat na dan in 1.200 mg enkrat na dan je bil bistveno učinkovitejši od placeba pri zmanjšanju pogostnosti epileptičnih napadov v 12-tedenskem vzdrževalnem obdobju.
Amber glass bottles with HDPE child resistant closures containing 200 ml oral suspension, inside a cardboard box.
Rjavkaste steklenice z za otroke varno zaporko iz HDPE, ki vsebujejo 200 ml peroralne suspenzije, v kartonski škatli.
Do not use this medicine after the expiry date, which is stated on the blister and the carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli poleg oznake »EXP«.
Children aged 6 years and below
Otroci, stari 6 ali manj let
The tablets are packaged in blisters in cardboard boxes containing 20 or 60 tablets, and in HDPE bottles with child resistant closure in cardboard boxes containing 60 tablets.
Tablete so pakirane v pretisne omote v kartonskih škatlah, ki vsebujejo 20 ali 60 tablet, in v steklenice iz HDPE z za otroke varno zaporko v kartonskih škatlah, ki vsebujejo 60 tablet.
Replace the closure on the bottle by turning it clock-wise (to the right).
8. korak: Zaporko namestite nazaj na steklenico z obračanjem v smeri urnega kazalca (v desno).
HDPE bottles with polypropylene child resistant closure, placed into cardboard boxes, containing 90 tablets.
Steklenice iz HDPE s polipropilensko za otroke varno zaporko, vložene v kartonske škatle, ki vsebujejo 90 tablet.
BIAL - Portela & Cª , S.A., À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal tel: +351 22 986 61 00 fax: +351 22 986 61 99 e-mail: info@bial.com
BIAL - Portela & Cª , S.A., À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugalska tel: +351 22 986 61 00 faks: +351 22 986 61 99 e-pošta: info@bial.com
Therefore it is recommended that you use other forms of safe and effective contraception, when taking Zebinix up to the end of the current menstrual cycle after stopping treatment.
Zato je med jemanjem zdravila Zebinix in do konca trenutnega menstrualnega cikla po končanem zdravljenju priporočeno uporabljati drugo obliko varne in učinkovite kontracepcije.
EU/1/09/514/012 20 tablets - ALU/ALU blister EU/1/09/514/013 30 tablets - ALU/ALU blister EU/1/09/514/014 60 tablets - ALU/ALU blister EU/1/09/514/015 90 tablets - ALU/ALU blister EU/1/09/514/016 20 tablets - PVC/ALU blister EU/1/09/514/017 30 tablets - PVC/ALU blister EU/1/09/514/018 60 tablets - PVC/ALU blister EU/1/09/514/019 90 tablets - PVC/ALU blister
EU/1/09/514/012 20 tablet - Pretisni omot iz ALU/ALU EU/1/09/514/013 30 tablet - Pretisni omot iz ALU/ALU EU/1/09/514/014 60 tablet - Pretisni omot iz ALU/ALU EU/1/09/514/015 90 tablet - Pretisni omot iz ALU/ALU EU/1/09/514/016 20 tablet - Pretisni omot iz PVC/ALU EU/1/09/514/017 30 tablet - Pretisni omot iz PVC/ALU EU/1/09/514/018 60 tablet - Pretisni omot iz PVC/ALU EU/1/09/514/019 90 tablet - Pretisni omot iz PVC/ALU
Eslicarbazepine acetate is extensively converted to eslicarbazepine.
Absorpcija Eslikarbazepinacetat se v veliki meri spremeni v eslikarbazepin.
Aluminium/Aluminium or PVC/Aluminium blisters placed into cardboard boxes containing 7, 14 or 28 tablets.
Pretisni omoti iz PVC/aluminija, vloženi v kartonske škatle, ki vsebujejo 7, 14 ali 28 tablet.
Because of the prevalence of this allele in other Asian populations (e.g, above 15% in the Philippines and Malaysia), testing genetically at risk populations for the presence of HLA- B*1502 may be considered.
Zaradi prevalence tega alela pri drugih azijskih populacijah (npr. več kot 15 % na Filipinih in v
There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures with structurally related antiepileptics medicines like carbamazepine and oxcarbazepine.
Pri uporabi strukturno sorodnih antiepileptikov, kot sta karbamazepin in okskarbazepin, so poročali o motnjah kosti, vključno z osteopenijo in osteoporozo (tanjšanjem kosti), ter o zlomih.
• Increased bone proteins;
• motnje v presnovi kosti, • zvišanje ravni kostnih beljakovin,
• Migraine;
• migrena,
Aluminium /Aluminium or PVC/Aluminium blisters placed into cardboard boxes containing 30 or 60 tablets.
Pretisni omoti iz PVC/aluminija, vloženi v kartonske škatle, ki vsebujejo 30 ali 60 tablet.
The most frequent individual adverse reactions were dizziness (12.5% of subjects), somnolence (9.7%), fatigue, convulsion and hyponatraemia (8.3%, each), nasopharyngitis (6.9%) and upper respiratory tract infection (5.6%).
utrujenost (8,3 %), konvulzije (8,3 %), hiponatriemija (8,3 %), nazofaringitis (6,9 %) in okužba zgornjih dihal (5,6 %).
Suicidal ideation and behaviour have been reported in patients treated with antiepileptic active substances in several indications.
Pri bolnikih, ki so se zaradi različnih indikacij zdravili z antiepileptiki, so poročali o samomorilnih mislih in vedenju.
Constipation, dyspepsia, gastritis, abdominal pain, dry mouth, abdominal discomfort, abdominal distension, gingivitis , melaena, toothache
neprijeten občutek v trebuhu, abdominalna distenzija, gingivitis, melena, zobobol pankreatitis
The doses of the active comparator, carbamazepine controlled release, were 200 mg, 400 mg and 600 mg, twice-daily.
Eslikarbazepinacetat so preskušali v odmerkih 800 mg, 1.200 mg in 1.600 mg z odmerjanjem enkrat na dan. Odmerki aktivnega primerjalnega zdravila, karbamazepina z nadzorovanim sproščanjem, so bili 200 mg, 400 mg in 600 mg z odmerjanjem dvakrat na dan.
Myalgia, bone metabolism disorder, muscular weakness, pain in extremity
Bolezni mišično skeletnega sistema in vezivnega tkiva mialgija, motnje v presnovi kosti, mišična šibkost, bolečina v okončinah
A meta-analysis of randomised placebo-controlled trials of antiepileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour.
Majhno povečanje tveganja za pojav samomorilnega razmišljanja in vedenja je pokazala tudi metaanaliza randomiziranih s placebom nadzorovanih kliničnih preskušanj antiepileptikov.
EU/1/09/514/001 7 tablets - ALU/ALU blister EU/1/09/514/002 14 tablets - ALU/ALU blister EU/1/09/514/003 28 tablets - ALU/ALU blister EU/1/09/514/004 7 tablets - PVC/ALU blister EU/1/09/514/005 14 tablets - PVC/ALU blister EU/1/09/514/006 28 tablets - PVC/ALU blister
EU/1/09/514/001 7 tablet - Pretisni omot iz ALU/ALU EU/1/09/514/002 14 tablet - Pretisni omot iz ALU/ALU EU/1/09/514/003 28 tablet - Pretisni omot iz ALU/ALU EU/1/09/514/004 7 tablet - Pretisni omot iz PVC/ALU EU/1/09/514/005 14 tablet - Pretisni omot iz PVC/ALU EU/1/09/514/006 28 tablet - Pretisni omot iz PVC/ALU
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Box of 30 or 60 tablets
PODATKI NA ZUNANJI OVOJNINI Škatla z 30 ali 60 tabletami
The starting dose is 10 mg per kg body weight taken once a day for one or two weeks, before increasing to the maintenance dose.
Začetni odmerek je 10 mg na kg telesne mase, ki se jemlje enkrat na dan en teden ali dva tedna,
• Clumsiness;
• nerodnost,
How to store Zebinix
Shranjevanje zdravila Zebinix
MINIMUM PARTICULARS TO APPEAR ON BLISTERS PVC/ALU blister
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU Pretisni omot iz PVC/ALU
• Severe pain in the back and stomach (caused by inflamation of the pancreas);
• zmanjšanje števila trombocitov, ki zveča tveganje za krvavitve ali modrice, • hude bolečine v hrbtu ali trebuhu (ki jih povzroči vnetje trebušne slinavke),
Nausea, vomiting, diarrhoea
Bolezni prebavil navzea, bruhanje, diareja zaprtost, dispepsija,
• Thermal burn;
• toplotne opekline,
Turn the bottle upright and remove the entire oral syringe from the bottle.
7. korak: Steklenico obrnite prav in odmerno brizgo odstranite iz steklenice.
• phenytoin (a medicine used to treat epilepsy) since your dose may need to be adjusted;
• fenitoin (zdravilo za zdravljenje epilepsije), ker bo morda moral prilagoditi odmerek; • karbamazepin (zdravilo za zdravljenje epilepsije), kajti morda bo treba prilagoditi odmerek;
Psychotic disorder, apathy, depression, nervousness, agitation, irritability, attention deficit/ hyperactivity disorder, confusional state, mood swings, crying, psychomotor retardation, anxiety
razdražljivost, motnje pozornosti/hiperaktivnost, stanje zmedenosti, spremembe razpoloženja,
HDPE bottles with polypropylene child resistant closure, inside a cardboard box, containing 60 tablets.
Steklenice iz HDPE s polipropilensko za otroke varno zaporko, vložene v kartonske škatle, ki vsebujejo 60 tablet.
Severe cutaneous adverse reactions (SCARS), including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in post-marketing experience with Zebinix treatment (see section 4.4).
V obdobju trženja so pri zdravljenju z zdravilom Zebinix poročali o hudih kožnih neželenih reakcijah, vključno s Stevens-Johnsonovim sindromom (SJS)/toksično epidermalno nekrolizo (TEN) ter reakcijo na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS) (glejte poglavje 4.4).
Adverse reactions associated with eslicarbazepine acetate obtained from clinical studies and postmarketing surveillance are tabulated below.
V spodnji preglednici so prikazani z eslikarbazepinacetatom povezani neželeni učinki v kliničnih študijah in iz izkušenj v obdobju trženja.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Box of 20 or 60 tablets
PODATKI NA ZUNANJI OVOJNINI Škatla z 20 ali 60 tabletami
Skin and subcutaneous tissue disorders
žolčnika in žolčevodov bolezni jeter
Ossification delays, reduced foetal weights, an increase in minor skeletal and visceral anomalies were observed at maternal toxic doses in embryotoxicity studies in mice, rats and rabbits.
V študijah embriotoksičnosti pri miših, podganah in kuncih so opazili zakasnitev okostenitve, zmanjšano maso fetusa, zvečanje manjših nenormalnosti okostja in drobovja.
Each ml of oral suspension contains 50 mg of eslicarbazepine acetate.
En ml peroralne suspenzije vsebuje 50 mg eslikarbazepinacetata.
• Feeling sick or vomiting;
• siljenje na bruhanje ali bruhanje,
The tablets have ‘ESL 600'engraved on one side and are scored on the other side, with a length of 17.3 mm.
Tablete imajo vtisnjen napis ‘ESL 600' na eni strani in zarezo na drugi, dolžine 17,3 mm. Tableta se lahko deli na enake odmerke.
The following convention has been used for the classification of adverse reactions very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and not known (frequency cannot be estimated from available data).
Pogostnost neželenih učinkov je razvrščena na naslednji način: zelo pogosti (≥ 1/10), pogosti (od
400 mg (or 10 mg/kg in children above 6 years)every other day for 2 weeks followed by a once daily dose of 400 mg (or 10 mg/kg in children above 6 years).
- CLCR 30-60 ml/min: začetni odmerek 200 mg (ali 5 mg/kg pri otrocih, starih več kot 6 let) enkrat dnevno ali 400 mg (ali 10 mg/kg pri otrocih, starih več kot 6 let) vsak drugi dan 2 tedna, nato 400 mg (ali 10 mg/kg pri otrocih, starih več kot 6 let) enkrat dnevno.
EU/1/09/514/007 30 tablets - ALU/ALU blister EU/1/09/514/008 60 tablets - ALU/ALU blister EU/1/09/514/009 30 tablets - PVC/ALU blister EU/1/09/514/010 60 tablets - PVC/ALU blister
EU/1/09/514/007 30 tablet - Pretisni omot iz ALU/ALU EU/1/09/514/008 60 tablet - Pretisni omot iz ALU/ALU EU/1/09/514/009 30 tablet - Pretisni omot iz PVC/ALU EU/1/09/514/010 60 tablet - Pretisni omot iz PVC/ALU
Contains methyl parahydroxybenzoate (E218) and sulphites See leaflet for further information
Vsebuje metilparahidroksibenzoat (E218) in sulfite.
• Medicine toxicity; • Anxiety.
• tesnoba (anksioznost).
This leaflet was last revised in MM/YYYY
Navodilo je bilo nazadnje revidirano dne {mesec LLLL }.
• Sedation;
• sedacija,
Metabolism and nutrition disorders
Bolezni živčevja in očesne bolezni
White oblong tablets, engraved ‘ESL 600'on one side and scored on the other side, with a length of 17.3 mm.
Bele, podolgovate tablete z vtisnjenim napisom ‘ESL 600' na eni strani in zarezo na drugi strani, dolžine 17,3 mm. Tableta se lahko deli na enake odmerke.
Hyponatraemia has been reported as an adverse reaction in 1.5% of patients treated with Zebinix.
Pri 1,5 % bolnikov, ki so prejemali zdravilo Zebinix, se je kot neželeni učinek pojavila hiponatriemija.
Thus, an increase in the dose of the medicinal products that are mainly metabolised through CYP3A4 may be required, when used concomitantly with eslicarbazepine acetate.
Zato bo pri sočasni uporabi z eslikarbazepinacetatom morda treba povečati odmerek zdravil, ki se presnavljajo s CYP3A4.
zebinix 200 mg (outer pack only)
zebinix 200 mg (samo zunanja ovojnina)
White circular biconvex tablets, engraved ‘ESL 400'on one side and scored on the other side, with a diameter of 11 mm..
Bele, okrogle, bikonveksne tablete z vtisnjenim napisom ‘ESL 400' na eni strani in zarezo na drugi strani, premera 11 mm. Tableta se lahko deli na enake odmerke.
400 mg (or 10 mg/kg in children above 6 years) every other day for 2 weeks followed by a once daily dose of 400 mg (or 10 mg/kg in children above 6 years).
400 mg (ali 10 mg/kg pri otrocih, starih več kot 6 let) enkrat dnevno.
zebinix 800 mg (outer pack only)
zebinix 800 mg (samo zunanja ovojnina)
• Itching;
• driska,
• Burning sensation;
pekoč občutek,
The tablets have ‘ESL 800'engraved on one side and are scored on the other side, with a length of 19 mm.
Tablete imajo vtisnjen napis ‘ESL 800' na eni strani in zarezo na drugi, dolžine 19 mm. Tableta se lahko deli na enake odmerke.
The treatment effect observed during the 26-week evaluation period was maintained over 1 year of treatment with 64.7 % eslicarbazepine acetate subjects and 70.3 % carbamazepine controlled release subjects classified as seizure free (average risk difference -5.46%, 95% confidence interval: [-11.88; 0.97].
Učinek zdravljenja, ki so ga opazili v 26-tedenskem obdobju ocenjevanja, se je ohranil skozi obdobje enega leta zdravljenja, pri čemer je bilo 64,7 % bolnikov, zdravljenih z eslikarbazepinacetatom, in 70,3 % bolnikov, zdravljenih s karbamazepinom z nadzorovanim sproščanjem, ocenjenih, da nimajo epileptičnih napadov (povprečna razlika v tveganju
There have been reports of decreased bone mineral density, osteopenia, osteoporosis and fractures in patients on long-term therapy with the structurally related antiepileptic drugs carbamazepine and oxcarbazepine.
Pri bolnikih, ki so se dolgotrajno zdravili s strukturno sorodnima antiepileptikoma karbamazepinom in okskarbazepinom, so poročali o zmanjšanju mineralne gostote kosti, osteopeniji, osteoporozi in zlomih.
Headache, disturbance in attention, tremor, ataxia, balance disorder
Omotica, somnolenca, vrtoglavica, astenija, motnje pri hoji, tremor,
During treatment with Zebinix dose adjustment is recommended in patients,adult and children above 6 years of age with creatinine clearance <60 ml/min (see section
Pri bolnikih, odraslih in otrocih, starih nad 6 let, s kreatininskim očistkom < 60 ml/min, je med zdravljenjem z zdravilom Zebinix priporočeno prilagoditi odmerek (glejte poglavje 4.2).
• Agitation;
• agitacija,
If patients of European descent or Japanese origin are known to be positive for HLA-A*3101 allele, the use of carbamazepine or chemically-related compounds may be considered if the benefits are thought to exceed risks.
A*3101, je mogoče o uporabi eslikarbazepinacetata razmisliti, če so pričakovane koristi večje od tveganj.
• Headache;
• glavobol,
zebinix 600 mg (outer pack only)
zebinix 600 mg (samo zunanja ovojnina)
White oblong tablets, engraved 'ESL 200' on one side and scored on the other side, with a length of 11 mm.
Bele, podolgovate tablete z vtisnjenim napisom ‘ESL 200' na eni strani in zarezo na drugi strani, dolžine 11 mm. Tableta se lahko deli na enake odmerke.
The pharmacokinetics of eslicarbazepine acetate has not been evaluated in patients with severe hepatic impairment.
Pri bolnikih s hudo jetrno okvaro farmakokinetike eslikarbazepinacetata niso ocenili.
HPDE bottles carton and HPDE bottles of 60 tablets
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI Škatla za steklenice iz HPDE in steklenice iz HPDE, ki vsebujejo 60 tablet
Urinary tract infection
Bolezni sečil okužba sečil
White oblong tablets, engraved ‘ESL 800'on one side and scored on the other side, with a length of 19 mm.
Bele, podolgovate tablete z vtisnjenim napisom ‘ESL 800' na eni strani in zarezo na drugi strani, dolžine 19 mm. Tableta se lahko deli na enake odmerke.
The tablets have ‘ESL 200'engraved on one side and are scored on the other side, with a length of 11 mm.
Tablete imajo vtisnjen napis ‘ESL 200' na eni strani in zarezo na drugi, dolžine 11 mm. Tableta se lahko deli na enake odmerke.
Severe cutaneous adverse reactions (SCARS) including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported in post-marketing experience with Zebinix treatment.
V obdobju trženja so pri zdravljenju z zdravilom Zebinix poročali o hudih kožnih neželenih reakcijah, vključno s Stevens-Johnsonovim sindromom (SJS)/toksično epidermalno nekrolizo (TEN) ter reakcijo na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS), ki so lahko življenjsko ogrožajoče ali smrtne.
Each tablet contains 200 mg of eslicarbazepine acetate.
Ena tableta vsebuje 200 mg eslikarbazepinacetata.
Zebinix 800 mg tablets are white and oblong.
Tablete Zebinix 800 mg so bele in podolgovate.
• Weight loss;
• izguba telesne mase,
• Seizures;
• zaprtost,
Outer carton / bottle
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI Škatla/steklenica
Thus, interactions can arise when co-administering high doses of eslicarbazepine acetate with medicinal products that are mainly metabolised by CYP2C19 (e.g. Phenytoin).
Eslikarbazepin zavira delovanje CYP2C19, zato lahko pride do interakcij pri sočasni uporabi velikih odmerkov eslikarbazepinacetata in zdravil, ki jih večinoma presnavlja
Zebinix 600 mg tablets are white and oblong.
Tablete Zebinix 600 mg so bele in podolgovate.
• Liver problems;
• težave z jetri,
• Feeling generally weak, unwell or having chills;
• okužba sečil, • splošna šibkost, slabo počutje ali mrzlica,
Zebinix 200 mg tablets are white and oblong.
Tablete Zebinix 200 mg so bele in podolgovate.
Co-administration of eslicarbazepine acetate 1,200 mg once daily with warfarin showed a small (23%), but statistically significant decrease in exposure to S-warfarin.
Varfarin Pri sočasni uporabi 1.200 mg eslikarbazepinacetata enkrat na dan in varfarina so opazili majhno
The tablets have ‘ESL 400'engraved on one side and are scored on the other side, with a diameter of 11 mm.
Na eni strani je vtisnjen napis ‘ESL 400', na drugi pa je zareza, premera 11 mm.
• Hearing difficulty;
• težave s sluhom,
There was an average decrease of 36-39% in systemic exposure in healthy subjects when co-administered with eslicarbazepine acetate 1,200 mg once daily.
Pri sočasni uporabi z eslikarbazepinacetatom v odmerku 1.200 mg enkrat dnevno je prišlo do povprečnega znižanja sistemske izpostavljenosti za 36-39 % pri zdravih preskušancih.
• Having falls;
• padci,
Serious and potentially life-threatening skin reactions including Stevens-Johnson syndrome/toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in post-marketing experience in patients treated with Zebinix.
V obdobju trženja so pri bolnikih, ki so se zdravili z zdravilom Zebinix, poročali o hudih kožnih neželenih reakcijah, vključno s Stevens-Johnsonovim sindromom/toksično epidermalno nekrolizo ter reakcijo na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS), ki so lahko tudi življenjsko ogrožajoče.
A.
SŠ:
Eslicarbazepine acetate
Eslikarbazepinacetat so preizkusili pri odmerkih
What you need to know before you take Zebinix 3.
Kaj je zdravilo Zebinix in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Zebinix Kako jemati zdravilo Zebinix
Annex B (variation to centrally authorised medicinal products)
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
Thrombocytopenia, leukopenia
parestezija, migrena
• Shaking;
• srbenje,
D.
dela).
Flavour Tutti-Frutti artificial (contains maltodextrin, propylene glycol, natural and artificial flavouring, and gum acacia (E414)
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi ksantanski gumi (E415) makrogol-100 stearat metilparahidroksibenzoat (E218) natrijev saharinat (E954) umetna aroma tutti frutti (vsebuje maltodekstrin, propilenglikol, naravne in umetne arome in arabski gumi (E414)) prekrivni okus (vsebuje propilenglikol, vodo in naravne ter umetne arome)
• with other antiepileptic medicines (adjunctive therapy), in adult, adolescents and children patients above 6 years of age, whoare experiencing seizures that affect one part of the brain (partial seizure).
• monoterapija pri zdravljenju parcialnih epileptičnih napadov s sekundarno generalizacijo ali brez nje pri odraslih z na novo diagnosticirano epilepsijo, • dodatno zdravljenje pri odraslih, mladostnikih in otrocih, starih več kot 6 let, s parcialnimi epileptičnimi napadi s sekundarno generalizacijo ali brez nje.
• Constipation;
hladne okončine
Pancreatitis
Okskarbazepin
Package leaflet: Information for the user Zebinix 50 mg/ml oral suspension
Navodilo za uporabo Zebinix 50 mg peroralna suspenzija eslikarbazepinacetat
• with other antiepileptic medicines (adjunctive therapy), in adult, adolescents and children patients above 6 years of age, who are experiencing seizures that affect one part of the brain (partial seizure).
starih več kot 6 let, ki imajo epileptične napade, ki prizadenejo en del možganov (parcialne epileptične napade).
Fatigue, gait disturbance, asthenia
apatija, depresija,
• Skin rash;
• kožni izpuščaj,
ANNEX I NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER
IME, FARMACEVTSKA OBLIKA, JAKOST, CILJNA ŽIVALSKA VRSTA, NAČIN UPORABE ZDRAVILA , IMETNIK(I) DOVOLJENJ(A) ZA PROM
The National Competent Authorities of Member States or Reference Member States if applicable, shall ensure that the following condition is fulfilled by the MAH(s):
Pristojni nacionalni organi ene ali več držav članic ali referenčnih držav članic, če je ustrezno, zagotovijo, da imetnik(i) dovoljenj za promet z zdravilom izpolnjuje(jo) naslednji pogoj:
Suspension of the marketing authorisations should be lifted when bioequivalence to an EU Reference Medicinal Product has been established based on a bioequivalence study conducted visà-vis the EU Reference Medicinal Product.
Začasen umik dovoljenj za promet z zdravilom se prekliče, ko se ugotovi biološka enakovrednost z referenčnim zdravilom, odobrenim v EU, na podlagi študije biološke enakovrednosti, opravljene glede na referenčno zdravilo, odobreno v EU.
Annex III Condition for lifting the suspension of the Marketing Authorisations
Pogoj za preklic začasnega umika dovoljenj za promet z zdravilom
The recommended dose is 10 mg per kilogram bodyweight.
Priporočeni odmerek je 10 mg na kilogram telesne mase.
What measures are being taken to ensure the safe and effective use of Zinplava?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Zinplava?
The full EPAR for Zinplava can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Zinplava je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Zinplava's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zato zaključil, da so koristi zdravila Zinplava večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.