FrancophonIA/ELRC3.0 huggingface dataset:
English: Rare side effects (may affect up to 1 in 1,000 people) serious allergic reaction, which causes swelling of the face or throat.
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1 000 bolnikov): resna alergijska reakcija, ki povzroča otekanje obraza ali grla.
English: A small number of people being treated with epilepsy medicines such as vigabatrin have had thoughts of harming or killing themselves.
Slovenian: Pri majhnem številu ljudi, ki so bili zdravljeni z zdravili za zdravljenje epilepsije, kot je vigabatrin, so se pojavile misli o samopoškodovanju ali samomoru.
English: If this happens, contact your child's doctor immediately.
Slovenian: Če se to zgodi, se takoj posvetujte z otrokovim zdravnikom.
English: Most of the patients with perimetry-confirmed defects have been asymptomatic.
Slovenian: Večina bolnikov, pri katerih so izpadi potrjeni s perimetrijo, je asimptomatskih.
English: You should discuss this possibility with the doctor before your child begins treatment and the doctor will tell you how to detect this side effect.
Slovenian: Preden vaš otrok začne z zdravljenjem, se morate o tej možnosti posvetovati z zdravnikom, ta pa vam bo povedal, kako zaznati ta neželeni učinek.
English: Patients should be evaluated for the presence of visual field defects (see also section 4.4).
Slovenian: Pri bolnikih je treba ovrednotiti prisotnost izpadov vidnega polja (glejte tudi poglavje 4.4).
English: Vigabatrin may increase the amount of amino acids in the urine possibly leading to a false positive test for certain rare genetic metabolic disorders (e.g., alpha aminoadipic aciduria).
Slovenian: Zaradi vigabatrina se lahko poveča količina aminokislin v urinu, kar lahko povzroči, da je test za določene redke genetske motnje presnove lažno pozitiven (npr. alfa-aminoadipična acidurija).
English: What you need to know before your child takes Kigabeq 3.
Slovenian: Kaj morate vedeti, preden bo vaš otrok vzel zdravilo Kigabeq 3.
English: Treatment in combination with other antiepileptic medicinal products for patients with resistant partial epilepsy (focal onset seizures) with or without secondary generalisation, that is where all other appropriate medicinal product combinations have proved inadequate or have not been tolerated.
Slovenian: zdravljenje bolnikov z rezistentno delno epilepsijo (napadi žariščnega izvora) s sekundarno generalizacijo ali brez nje v kombinaciji z drugimi protiepileptičnimi zdravili, tj. če so se vse druge primerne kombinacije zdravil izkazale za neustrezne ali pa jih bolnik ni prenašal.
English: If a patient is to be withdrawn from vigabatrin treatment, it is recommended that this is done by gradual dose reduction over a 2- to 4-week period.
Slovenian: Če bo bolniku zdravljenje z vigabatrinom ukinjeno, je to priporočljivo storiti s postopnim zmanjšanjem odmerka v obdobju od 2 do 4 tednov.
English: Use immediately following preparation of the oral solution.
Slovenian: Uporabite takoj po pripravi peroralne raztopine.
English: It is usually detected after months or years of treatment with vigabatrin.
Slovenian: Običajno je zaznana po več mesecih ali letih po zdravljenju z vigabatrinom.
English: Animal safety studies carried out in the rat, mouse, dog and monkey have indicated that vigabatrin has no significant adverse reactions on the liver, kidney, lung, heart or gastrointestinal tract.
Slovenian: Študije varnosti pri živalih, ki so jih izvedli pri podganah, miših, psih in opicah, so pokazale, da vigabatrin nima pomembnih neželenih učinkov na jetra, ledvica, pljuča, srce ali prebavni trakt.
English: Read all of this leaflet carefully before you give this medicine to your child because it contains important information.
Slovenian: Preden svojemu otroku daste to zdravilo, natančno preberite navodilo, ker vsebuje pomembne podatke!
English: Controlled and long-term clinical trials have shown that vigabatrin is an effective anticonvulsant agent when given as first line treatment in patients with infantile spasms and as add-on therapy in patients with epilepsy not controlled satisfactorily by conventional therapy.
Slovenian: Klinična učinkovitost in varnost V kontroliranih in dolgoročnih kliničnih preskušanjih so dokazali, da je vigabatrin učinkovito sredstvo proti konvulzijam, če se daje bolnikom z infantilnimi spazmi kot zdravljenje prve linije, bolnikom z epilepsijo, ki z običajnim zdravljenjem ni dovolj nadzorovana, pa kot dodatno zdravljenje.
English: In view of the fact that drowsiness has been observed in clinical trials with vigabatrin, patients should be warned of this possibility at the start of treatment.
Slovenian: Glede na dejstvo, da so v kliničnih študijah vigabatrina opazili zaspanost, je treba na začetku zdravljenja bolnike na to opozoriti.
English: • Give the mixture straightway to your child direct from the drinking glass or beaker
Slovenian: • Otroku dajte mešanico takoj, neposredno iz kozarca ali čaše.
English: Animal experiments have shown that vigabatrin has no negative influence on fertility or pup development.
Slovenian: S poskusi na živalih so dokazali, da vigabatrin nima negativnega vpliva na plodnost ali razvoj mladičev.
English: Some patients may have more seizures (fits) whilst taking Kigabeq.
Slovenian: Nekateri bolniki imajo lahko med jemanjem zdravila Kigabeq več epileptičnih napadov (krčev).
English: Oral clearance (Cl/F) of vigabatrin is approximately 7 l/h (i.e. 0.10 l/h/kg).
Slovenian: vigabatrina znaša približno 7 l/uro (tj. 0,10 l/uro/kg).
English: Wait until the tablet(s) fully disintegrate; tablets generally disintegrate in less than one minute but disintegration can be fastened by gently hand stirring the oral solution.
Slovenian: Počakajte, da se tablete v celoti razkrojijo; to običajno traja manj kot eno minuto, ta čas pa je mogoče skrajšati tako, da peroralno raztopino nežno ročno mešate.
English: Rare reports of encephalopathic symptoms such as marked sedation, stupor and confusion in association with non-specific slow wave activity on electroencephalogram have been described soon after the initiation of vigabatrin treatment.
Slovenian: Opisana so redka poročila o encefalopatičnih simptomih, kot so izražena sedacija, omamljenost in zmedenost v povezavi z nespecifično dejavnostjo počasnih valov na elektroencefalogramu, ki so se pojavili kmalu po začetku zdravljenja z vigabatrinom.
English: Patients (and caregivers of patients) should be advised to seek medical advice immediately should signs of suicidal ideation or behaviour emerge.
Slovenian: Bolnikom (in njihovim skrbnikom) je treba svetovati, da ob pojavu znakov samomorilnih misli ali vedenja takoj poiščejo zdravniško pomoč.
English: The magnitude of suppression for ALT has been reported to vary between 30% and 100%.
Slovenian: Poročali so, da obseg zmanjšanja ALT znaša med 30 %
English: Vigabatrin is a water soluble compound and it is rapidly and completely absorbed from the gastrointestinal tract.
Slovenian: Vigabatrin je v vodi topna spojina ter se hitro in popolnoma absorbira iz prebavil.
English: If new movement disorders occur during treatment with vigabatrin, consideration should be given to dose reduction or a gradual discontinuation of treatment.
Slovenian: Če se med zdravljenjem z vigabatrinom pojavijo nove motnje gibanja, je treba premisliti o zmanjšanju odmerka ali postopni ukinitvi zdravljenja.
English: This is normal and due to presence of water-insoluble excipients.
Slovenian: To je običajno in posledica prisotnosti pomožnih snovi, ki v vodi niso topne.
English: When provided, doses were most commonly between 7.5 to 30 g; however, ingestions up to 90 g have been reported.
Slovenian: Kjer so bili podani, so odmerki najpogosteje znašali od 7,5 do 30 g, vendar so poročali tudi o zaužitjih odmerkov, ki so znašali do 90 g. Skoraj polovica primerov je vključevala zaužitje več zdravil.
English: Vigabatrin is a selective irreversible inhibitor of GABA transaminase, the enzyme responsible for the breakdown of GABA (gamma aminobutyric acid).
Slovenian: Vigabatrin je selektivni ireverzibilni zaviralec transaminaze GABA, encima, ki je odgovoren za razgradnjo GABA (gama aminomaslene kisline).
English: The solution in water is whitish and cloudy.
Slovenian: Raztopina v vodi je belkasta in motna.
English: Abnormal Magnetic Resonance Imaging signals
Slovenian: Neobičajni signali pri slikanju z magnetno resonanco
English: Vigabatrin is not metabolised by hepatic enzymes, hence there is no need of adjustment of dose or frequency of administration.
Slovenian: Vigabatrin se ne presnavlja prek jetrnih encimov, zato odmerka ali pogostnosti dajanja odmerka ni treba prilagajati.
English: 10, rue Bouché Thomas ZAC d'Orgemont F-49000 Angers France
Slovenian: 10 rue Bouché Thomas ZAC d'Orgemont F-49000 Angers 49000 Angers Francija
English: What Kigabeq is and what it is used for 2.
Slovenian: Kaj je zdravilo Kigabeq in za kaj ga uporabljamo 2.
English: Laboratory data indicate that vigabatrin treatment does not lead to renal toxicity.
Slovenian: Laboratorijski podatki kažejo, da zdravljenje z vigabatrinom ne povzroča toksičnosti za ledvice.
English: The gastric tube should be rinsed with 10 ml of water.
Slovenian: Gastrično sondo je treba splakniti z 10 ml vode.
English: Kigabeq is available as 100 mg or 500 mg tablets which can be given together to make up the right dose for your child.
Slovenian: Zdravilo Kigabeq je na voljo v obliki 100- ali 500-miligramskih tablet, ki jih je mogoče dati skupaj, da je dosežen pravi odmerek za vašega otroka.
English: If you have any further questions on the use of this medicine, ask the doctor or pharmacist.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali farmacevtom.
English: Once the child has entirely drunk the medicine solution, the drinking glass should be rinsed with one or two teaspoons of water (approximately 5 or 10 ml) and dispensed to the child by the same way.
Slovenian: Ko otrok do konca spije raztopino zdravila, je treba kozarec splakniti z eno ali dvema čajnima žličkama vode (približno 5 ali 10 ml) in to dati otroku na enak način.
English: The parents and/or caregivers must be given a thorough description of the frequency and implications of the development of VFD during vigabatrin treatment.
Slovenian: Staršem in/ali skrbnikom je treba podati podroben opis pogostnosti in posledic razvoja izpada vidnega polja med zdravljenjem z vigabatrinom.
English: Therefore, these liver tests may be quantitatively unreliable in patients taking vigabatrin (see section 4.8).
Slovenian: Zato so ti jetrni testi pri bolnikih, ki jemljejo vigabatrin, lahko nezanesljivi (glejte poglavje 4.8).
English: Pharmacokinetic properties of vigabatrin have been investigated in groups of six neonates (age 1526 days), six infants (age 5-22 months) and six children (age 4.6-14.2 years) with refractory epilepsy.
Slovenian: 26 dni), šestih dojenčkov (starih 5-22 mesecev) in šestih otrok (starih 4,6-14,2 leta) z refraktarno epilepsijo.
English: Do not give Kigabeq: if your child is allergic to vigabatrin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če je vaš otrok alergičen na vigabatrin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: If a visual field constriction is observed during follow-up, consideration should be given to gradual discontinuation of vigabatrin.
Slovenian: Če je med kontrolnim pregledom opaženo zoženje vidnega polja, je treba premisliti o postopni ukinitvi vigabatrina.
English: Depression was a common psychiatric reaction in clinical trials but seldom required discontinuation of vigabatrin.
Slovenian: V kliničnih študijah je bila pogosta psihiatrična reakcija depresija, a je redko zahtevala prekinitev zdravljenja z vigabatrinom.
English: Patients should be monitored for adverse reactions such as sedation or confusion (see sections 4.4 and 4.8).
Slovenian: Pri bolnikih je treba spremljati neželene učinke, kot sta sedacija ali zmedenost (glejte poglavji 4.4 in 4.8).
English: In both rat and dog they were reversible on stopping vigabatrin treatment and even regressed with continued treatment.
Slovenian: Pri podganah in psih so bile ob zaustavitvi zdravljenja z vigabatrinom reverzibilne in so se ob nadaljevanju zdravljenja celo zmanjšale.
English: In isolated case reports in renal failure patients receiving therapeutic doses of vigabatrin, haemodialysis reduced vigabatrin plasma concentrations by 40% to
Slovenian: V poročilih o izoliranih primerih pri bolnikih z odpovedjo ledvic, ki so prejemali terapevtske odmerke vigabatrina, so bile plazemske koncentracije vigabatrina s hemodializo zmanjšane za vrednost, ki je znašala od 40 % do 60 %.
English: Vigabatrin-associated retinotoxicity has been observed in 80-100% of albino rats at the dose of 300 mg/kg/day orally, but not in pigmented rats, dogs or monkeys.
Slovenian: Pri 80-100 % podgan z albinizmom so pri peroralnem odmerku 300 mg/kg/dan opazili z vigabatrinom povezano toksičnost za mrežnico, ki pa je pri pigmentiranih podganah, psih in opicah niso opazili.
English: Very common side effects (may affect more than 1 in 10 people) Visual field changes - About 33 out of 100 patients treated with vigabatrin may have changes in the visual field (narrow visual field).
Slovenian: - spremembe vidnega polja - pri približno 33 od 100 bolnikov, ki so zdravljeni z vigabatrinom, lahko nastopijo spremembe vidnega polja (ozko vidno polje).
English: There is no direct correlation between plasma concentration and efficacy.
Slovenian: Farmakokinetično/farmakodinamično razmerje Med plazemsko koncentracijo in učinkovitostjo ni neposredne povezave.
English: Childre n Do not give this medicine to children less than 1 month of age or more than 7 years of age.
Slovenian: Tega zdravila ne dajajte otrokom, ki so mlajši od 1 meseca ali starejši od 7 let.
English: Vigabatrin is not significantly metabolised.
Slovenian: Vigabatrin se ne presnavlja v pomembni meri.
English: For younger patients electroretinography should be used (see Visual Field Defects).
Slovenian: Pri mlajših bolnikih je treba uporabiti elektroretinografijo (glejte poglavje o izpadih vidnega polja).
English: • Add the right dose of Kigabeq tablets (as whole or half tablets) to the water
Slovenian: • Vodi dodajte pravilen odmerek tablet zdravila Kigabeq (celih tablet ali polovic).
English: Very rare side effects (may affect up to 1 in 10,000 people) other eye problems such as pain in eyes (optic neuritis) and loss of vision, including colour vision (optic atrophy) hallucinations (feeling, seeing or hearing things that are not there) liver problems
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov): druge težave z očmi, kot sta bolečina v očeh (optični nevritis) in izguba vida, vključno z barvnim vidom (optično atrofijo); halucinacije (občutenje, videnje ali slišanje zadev, ki ne obstajajo);
English: The solution should be administered immediately after preparation.
Slovenian: To raztopino je treba dati takoj, ko je pripravljena.
English: Skin and subcutaneou s tissue disorders rash angioede ma, urticaria
Slovenian: Bolezni kože in podkožja izpuščaj angioede m, urtikarija
English: Body weight (kg)
Slovenian: Telesna masa (v kg)
English: Based on the available data the first oscillatory potential and 30 Hz flicker responses of the electroretinogram appear to be correlated with a vigabatrin associated VFD.
Slovenian: Zdi se, da sta prvi oscilatorni potencial in odzivi 30 Hz bliskovnega elektroretinograma po razpoložljivih podatkih v tesni zvezi z izpadom vidnega polja, povezanega z vigabatrinom.
English: New onset myoclonus and exacerbation of existing myoclonus may occur in rare cases.
Slovenian: V redkih primerih lahko pride do novih nastopov mioklonusa in poslabšanja obstoječega mioklonusa.
English: Investigation s weight increased
Slovenian: Preiskave povečana telesna masa
English: For patients who cannot swallow, administration of Kigabeq using a gastric tube is possible.
Slovenian: Bolnikom, ki ne morejo požirati, je zdravilo Kigabeq mogoče dati z gastrično sondo.
English: The doctor will check your child's visual field before your child starts taking vigabatrin and carry on checking it at regular intervals during the treatment.
Slovenian: Preden bo vaš otrok začel jemati vigabatrin, bo zdravnik preveril njegovo vidno polje in ga bo med zdravljenjem redno preverjal.
English: Vigabatrin should not be used concomitantly with other retinotoxic medicinal products.
Slovenian: Vigabatrin se ne sme uporabljati sočasno z drugimi zdravili, ki so toksična za mrežnico.
English: Decreases in ALT and AST, which are considered to be a result of inhibition of these aminotransferases by vigabatrin, have been observed.
Slovenian: Opazili so zmanjšanja ALT in AST, za katere velja, da je do njih prišlo, ker vigabatrin zavira te aminotransferaze.
English: Other medicines and Kigabeq
Slovenian: Druga zdravila in zdravilo Kigabeq
English: • Rinse the glass or beaker with one or two teaspoonfuls (about 5 to 10 ml) of water and give this to your child to make sure that the child receives all the medicine
Slovenian: • Splaknite kozarec ali čašo z eno ali dvema čajnima žličkama (približno od 5 do 10 ml) in to mešanico dajte svojemu otroku, da bo zagotovo prejel celotno zdravilo.
English: Other less frequently reported symptoms included vertigo, headache, psychosis, respiratory depression or apnoea, bradycardia, hypotension, agitation, irritability, confusion, abnormal behaviour, and speech disorder.
Slovenian: Drugi simptomi, o katerih so poročali manj pogosto, so vključevali vrtoglavico, glavobol, psihozo, respiratorno depresijo ali apnejo, bradikardijo, hipotenzijo, vznemirjenje, razdražljivost, zmedenost, neobičajno vedenje in motnje govora.
English: Patients with myoclonic seizures may be particularly susceptible to this effect.
Slovenian: Za ta učinek so lahko še posebej dojemljivi bolniki z miokloničnimi napadi.
English: Some patients may experience an increase in seizure frequency, including status epilepticus with vigabatrin.
Slovenian: Pri nekaterih bolnikih se lahko zaradi vigabatrina pogostnost napadov, vključno z epileptičnim statusom, poveča.
English: The tube should be rinsed with 10 ml of water
Slovenian: Sondo je treba splakniti z 10 ml vode.
English: If your child has visual disturbances, contact your child's doctor or hospital immediately.
Slovenian: Če ima vaš otrok motnje vida, se takoj posvetujte z njegovim zdravnikom ali bolnišnico.
English: Since vigabatrin is eliminated via the kidneys, caution should be exercised when administering the medicinal product to patients with creatinine clearance less than 60 ml/min.
Slovenian: Ker se vigabatrin izloča prek ledvic, je pri dajanju zdravila bolnikom, pri katerih je očistek kreatinina manjši od 60 ml/min, potrebna previdnost.
English: What Kigabeq is and what it is used for
Slovenian: Kaj je zdravilo Kigabeq in za kaj ga uporabljamo
English: A deterioration of VFD after the treatment is discontinued cannot be excluded.
Slovenian: Poslabšanja izpadov vidnega polja po prekinitvi zdravljenja ni mogoče izključiti.
English: Electroretinography is recommended in infants and children who are unable to cooperate with perimetry.
Slovenian: Pri dojenčkih in otrocih, ki pri perimetriji ne morejo sodelovati, se priporoča elektroretinografija.
English: No teratogenicity was seen in rats in doses up to 150 mg/kg (3 times the human dose) or in rabbits in doses up to 100 mg/kg.
Slovenian: Pri podganah, ki so prejemale odmerke do 150 mg/kg (kar je 3-kratna vrednost odmerka pri človeku) in pri kuncih, ki so prejemali odmerke do 100 mg/kg, niso opazili teratogenosti.
English: Movement disorders can occur in young infants treated for infantile spasms (West's syndrome).
Slovenian: Pri majhnih dojenčkih, zdravljenih zaradi infantilnih spazmov (Westovega sindroma) se lahko pojavijo motnje gibanja.
English: If your child has these symptoms, you should tell his/her doctor immediately hives or nettle rash marked sedation (sleepiness), stupor and confusion (encephalopathy).
Slovenian: Če so se pri vašem otroku pojavili ti simptomi, morate to takoj povedati njegovemu zdravniku; koprivnica ali urtikarija; izražena sedacija (zaspanost), omamljenost in zmedenost (encefalopatija).
English: If your child takes too much Kigabeq
Slovenian: Če otrok vzame preveč zdravila Kigabeq
English: Available data suggests that visual field defects are irreversible.
Slovenian: Razpoložljivi podatki kažejo, da so izpadi vidnega polja ireverzibilni.
English: This medicinal product is not intended for use in women who are breastfeeding.
Slovenian: To zdravilo ni namenjeno uporabi pri ženskah, ki dojijo.
English: The most commonly reported adverse reaction related to vigabatrin are visual field defects (ranging from mild to severe and occurring usually after months to years of vigabatrin therapy), psychiatric disorders such as agitation, excitation, aggression, nervousness, depression, paranoid reaction, nervous system disorders such as marked sedation, stupor and confusion.
Slovenian: Neželeni učinki, povezani z vigabatrinom, o katerih so največkrat poročali, so izpadi vidnega polja (ki segajo od blagih do resnih in se običajno pojavljajo nekaj mesecev ali let po zdravljenju z vigabatrinom), psihične motnje, kot so vznemirjenje, razburjenje, agresija, živčnost, depresija, paranoidna reakcija, ter motnje živčnega sistema, kot so izražena sedacija, omamljenost in zmedenost.
English: If you have any further questions, ask your child's doctor or pharmacist.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z otrokovim zdravnikom ali farmacevtom.
English: • Pour one or two teaspoonfuls (about 5 to 10 ml) of water into a drinking glass or beaker
Slovenian: • Eno ali dve čajni žlici (približno od 5 do 10 ml) vode nalijte v kozarec ali čašo.
English: Table 2: Number of soluble tablets according to body weight and starting dose in resistant partial epilepsy
Slovenian: Preglednica 2: število tablet za peroralno raztopino v skladu s telesno maso in začetnim odmerkom pri rezistentni delni epilepsiji Telesna masa (kg)
English: If at any time your child has had these symptoms, immediately contact child's doctor.
Slovenian: Če so bili pri vašem otroku kadar koli izraženi taki simptomi, se takoj posvetujte z njegovim zdravnikom.
English: Always check the label and the size of the tablets to make sure you are giving the right dose.
Slovenian: Da boste zagotovo dali pravi odmerek, vedno preverite nalepko in velikost tablet.
English: Vigabatrin treatment may only be initiated by a specialist in epileptology, neurology or paediatric neurology.
Slovenian: Zdravljenje z vigabatrinom lahko uvede le specialist na področju epileptologije, nevrologije ali pediatrične nevrologije.
English: These side effects usually stop when doses are reduced or the medicine is gradually discontinued.
Slovenian: Ti neželeni učinki običajno izginejo ob zmanjšanju odmerkov ali ob postopni ukinitvi zdravila.
English: The method of administration will be determined by a physician specialised in epileptology, neurology or paediatric neurology.
Slovenian: Način uporabe bo določil zdravnik, specializiran za epileptologijo, nevrologijo ali pediatrično nevrologijo.
English: This visual field defect can range from mild to severe.
Slovenian: Ta okvara vidnega polja je lahko blaga do resna.
English: Visual field defects (VFD) have been reported in patients receiving vigabatrin with a high prevalence (about 1/3 of patients).
Slovenian: Pri bolnikih, ki so prejemali vigabatrin, so poročali o visoki prevalenci izpadov vidnega polja (pojavili so se pri 1/3 bolnikov).
English: These reactions occurred in patients with and without a psychiatric history and were usually reversible when vigabatrin doses were reduced or gradually discontinued (see section 4.4).
Slovenian: Do teh reakcij je prišlo pri bolnikih s psihiatrično anamnezo in pri bolnikih brez nje, običajno pa so bili ob zmanjšanju odmerkov vigabatrina ali postopni prekinitvi zdravljenja z njim reverzibilni (glejte poglavje 4.4).
English: Some patients may experience an increase in seizure frequency or the onset of new types of seizures with vigabatrin (see section 4.8).
Slovenian: Pri nekaterih bolnikih se lahko zaradi vigabatrina poveča pogostnost napadov ali pa pride do nastopa novih vrst napadov (glejte poglavje 4.8).