FrancophonIA/ELRC3.0 huggingface dataset:
English: The tablets are scored on one side and can be divided into equal doses.
Slovenian: Tablete imajo na eni strani zarezo in jih je mogoče razdeliti na enake odmerke.
English: to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Slovenian: ≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznani (iz razpoložljivih podatkov jih ni mogoče oceniti).
English: The risks of treatment must be very carefully weighed against possible benefit in children.
Slovenian: Pri otrocih je treba zelo skrbno pretehtati tveganje zdravljenja glede na morebitne koristi.
English: When reported, the most common symptoms included drowsiness or coma.
Slovenian: Kadar so poročali o simptomih, so najpogostejši simptomi vključevali zaspanost ali komo.
English: White oval tablets.
Slovenian: Bele ovalne tablete.
English: Based on available data, the usual pattern is a concentric constriction of the visual field of both eyes, which is generally more marked nasally than temporally.
Slovenian: Običajni vzorec na podlagi razpoložljivih podatkov je koncentrična zožitev vidnega polja obeh oči, ki je v splošnem nazalno bolj izrazita kot temporalno.
English: Risk of medication error
Slovenian: Tveganje napake pri uporabi zdravila
English: However, do not decrease the dose without first talking to your child's doctor.
Slovenian: Vendar odmerka ne zmanjšujte, ne da bi se najprej posvetovali z otrokovim zdravnikom.
English: This medicine should be used within 100 days after first opening.
Slovenian: To zdravilo morate porabiti v 100 dneh po odprtju plastenke.
English: This visual field loss may be severe and permanent, so it must be detected early to avoid progression.
Slovenian: Taka izguba vidnega polja je lahko resna in trajna, zato jo je treba zaznati zgodaj, da se prepreči napredovanje.
English: Therefore, patients should be monitored for signs of suicidal ideation and behaviour, and appropriate treatment should be considered.
Slovenian: Zato je treba bolnike spremljati glede znakov in simptomov samomorilnih misli in vedenja ter razmisliti o ustreznem zdravljenju.
English: The duration of the effect of the medicinal product is dependent on the GABA transaminase re-synthesis rate.
Slovenian: Trajanje učinka zdravila je odvisno od hitrosti ponovne sintetizacije transaminaze GABA.
English: Special care should be taken with young patients cycling, climbing or performing any other hazardous activity.
Slovenian: Posebna skrb je potrebna pri mladih bolnikih, ko kolesarijo, plezajo ali izvajajo kakršno koli drugo nevarno dejavnost.
English: Possible signs of overdose include drowsiness or reduced level of consciousness.
Slovenian: Možni znaki prevelikega odmerjanja vključujejo zaspanost ali zmanjšano raven zavesti.
English: Frequency and severity have only been indirectly characterised in this population on the presence of electroretinogram or visual evoked potential anomalies.
Slovenian: Pogostnost in resnost sta bili pri tej populaciji opredeljeni le posredno z elektroretinogramom ali z vizualno izzvanimi potencialnimi nepravilnostmi.
English: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000
Slovenian: zelo pogosti (≥ 1/10); pogosti (od ≥ 1/100 do < 1/10); občasni (od ≥ 1/1.000 do < 1/100); redki (od
English: Interference with serological testing
Slovenian: Motnje serološkega testiranja
English: Risk factors for the development of these reactions include higher than recommended starting dose, faster dose escalation at higher steps than recommended and renal failure.
Slovenian: Dejavniki tveganja za razvoj teh reakcij vključujejo začetni odmerek, ki je višji od priporočenega, hitrejše povečanje odmerka v večjih korakih, kot so priporočeni, in odpoved ledvic.
English: Patients were split in three treatment groups: patients currently treated with vigabatrin (group I), patients previously exposed to vigabatrin (group II) and patients never exposed to vigabatrin (group III).
Slovenian: Bolniki so bili razdeljeni v tri skupine zdravljenja: v skupino bolnikov, ki so trenutno zdravljeni z vigabatrinom (skupino I), skupino bolnikov, ki so bili prej izpostavljeni vigabatrinu (skupino II) in skupino bolnikov, ki niso bili nikoli izpostavljeni vigabatrinu (skupino III).
English: Approximately 70% of a single oral dose was recovered as unchanged drug in the urine in the first 24 hours post-dose.
Slovenian: Približno 70 % posameznega peroralnega odmerka je bilo v prvih 24 urah v urinu v obliki nespremenjenega zdravila.
English: Undesirable effects ranked under headings of frequency are listed below, using the following convention:
Slovenian: Neželeni učinki, razvrščeni po skupinah glede na pogostnost, so spodaj našteti po naslednjem dogovoru:
English: This leaflet was last revised in {month YYYY}.
Slovenian: Navodilo je bilo nazadnje revidirano dne (mesec LLLL).
English: Median treatment duration: 44.4 months, mean daily dose 1.48 g 2 Median treatment duration: 20.6 months, mean daily dose 1.39 g 3 Median treatment duration: 48.8 months, mean daily dose 2.10 g Median treatment duration: 23.0 months, mean daily dose 2.18 g
Slovenian: 1 Mediana vrednost trajanja zdravljenja: 44,4 meseca, srednja vrednost dnevnega odmerka 1,48 g 2 Mediana vrednost trajanja zdravljenja: 20,6 meseca, srednja vrednost dnevnega odmerka 1,39 g 3 Mediana vrednost trajanja zdravljenja: 48,8 meseca, srednja vrednost dnevnega odmerka 2,10 g 4 Mediana vrednost trajanja zdravljenja: 23,0 meseca, srednja vrednost dnevnega odmerka 2,18 g
English: In the central visual field (within 30 degree of eccentricity), frequently an annular nasal defect is seen.
Slovenian: V centralnem vidnem polju (znotraj 30-stopinjske ekscentričnosti) je pogosto mogoče opaziti obročast nazalni izpad.
English: Neurologic and psychiatric conditions
Slovenian: Nevrološka in psihiatrična stanja
English: Since no stability studies have been performed with other solvents than water, for preparing oral solution only water should be used.
Slovenian: Ker ni izvedenih nobenih študij stabilnosti z drugimi topili, razen z vodo, je treba za pripravo peroralne raztopine uporabiti vodo.
English: Mean terminal half-life of vigabatrin was about 7.5 hours in neonates, 5.7 hours in infants and 5.5 hours in children.
Slovenian: Srednja vrednost končne razpolovne dobe vigabatrina je pri novorojenčkih znašala približno 7,5 ur, pri dojenčkih 5,7 ur in pri otrocih 5,5 ur.
English: Most patients with perimetry-confirmed defects had not previously spontaneously noticed any symptoms, even in cases where a severe defect was observed in perimetry.
Slovenian: Večina bolnikov, pri katerih so bili izpadi potrjeni s perimetrijo, prej sami niso opazili nobenih simptomov, niti v primerih, pri katerih je bil s perimetrijo ugotovljen resen izpad.
English: This takes less than a minute but you can speed it up by stirring the mixture gently by hand
Slovenian: To traja manj kot minuto, lahko pa ta čas še skrajšate, tako da mešanico nežno ročno mešate.
English: The benefit/risk ratio of vigabatrin should be evaluated on an individual patient basis.
Slovenian: Razmerje med koristmi in tveganji vigabatrina je treba ovrednotiti pri vsakem posameznem bolniku posebej.
English: Studies with vigabatrin revealed no evidence of mutagenic or carcinogenic effects.
Slovenian: Študije vigabatrina niso odkrile dokazov o mutagenih ali karcinogenih učinkih.
English: Tell your child's doctor if your child has had or is going to perform laboratory tests because this medicine may lead to abnormal results.
Slovenian: Otrokovega zdravnika obvestite tudi, če je vaš otrok opravil ali bo opravljal laboratorijske teste, saj lahko to zdravilo povzroča neobičajne rezultate.
English: Fertility studies in rats have shown no effect on male and female fertility (see section 5.3).
Slovenian: V študijah plodnosti pri podganah niso dokazali nobenega učinka na plodnost samcev in samic (glejte poglavje 5.3).
English: In view of the results of the animal safety studies (see section 5.3) it is recommended that patients treated with vigabatrin are closely observed for adverse reactions on neurological function.
Slovenian: Z vidika rezultatov študij varnosti pri živalih (glejte poglavje 5.3) je pri bolnikih, zdravljenih z vigabatrinom, priporočljivo skrbno spremljanje neželenih učinkov na nevrološko funkcijo.
English: Hence, this undesirable effect can only be reliably detected by systematic perimetry which is usually possible only in patients with a developmental age of more than 9 years.
Slovenian: Zato je ta neželeni učinek mogoče zanesljivo zaznati le s sistematično perimetrijo, ki je običajno mogoča le pri bolnikih,
English: Visual field defect with non-identified aetiology:
Slovenian: Izpad vidnega polja brez opredeljene etiologije:
English: Tell your child's doctor if the child is taking, has recently taken or might take any other medicines.
Slovenian: Obvestite otrokovega zdravnika, če otrok jemlje, je pred kratkim jemal ali pa bo morda začel jemati katero koli drugo zdravilo.
English: The following table gives the number of Kigabeq tablets to give to your child according to the dose prescribed by your child's doctor.
Slovenian: V naslednji tabeli je podano število tablet zdravila Kigabeq za dajanje vašemu otroku v skladu z odmerkom, ki ga je predpisal otrokov zdravnik.
English: If there is a risk of regurgitation or if the child is not old enough to drink from a glass, the whole content of solution should be withdrawn with a syringe for oral use, the end of the syringe should be put in the mouth of the child and gently pushed on the plunger.
Slovenian: Če obstaja nevarnost bruhanja ali če otrok ni dovolj star za pitje iz kozarca, je treba vso vsebino posrkati z brizgo za peroralno uporabo, postaviti konec brizge v otrokova usta in nežno pritisniti bat brizge.
English: Visual field testing should continue at 6 month intervals for the whole duration of treatment.
Slovenian: Testiranje vidnega polja je treba nadaljevati v 6-mesečnih časovnih presledkih v celotnem obdobju zdravljenja.
English: Severe cases are potentially disabling.
Slovenian: Resni primeri lahko vodijo v invalidnost.
English: In a retrospective epidemiologic study in infants with infantile spasms (N=205), the prevalence of these changes was 22% in vigabatrin treated patients versus 4% in patients treated with other therapies.
Slovenian: V retrospektivni epidemiološki študiji pri dojenčkih z infantilnimi spazmi (N = 205) je pri bolnikih, zdravljenih z vigabatrinom, prevalenca teh sprememb znašala 22 %, pri bolnikih, zdravljenih z drugimi zdravili, pa 4 %.
English: • If your child cannot drink from the glass or beaker then you can use an oral syringe to gently squirt the mixture into your child's mouth, taking care not to cause choking: sit just in front and below your child in order that he/she has the head leaning forward and administer the mixture against his cheek
Slovenian: • Če vaš otrok ne more piti iz kozarca ali čaše, lahko za nežno izbrizganje mešanice v otrokova usta uporabite peroralno brizgo, pri tem pa pazite, da ne boste povzročili dušenja: sedite tik pred in pod otrokom, tako da bo njegova glava nagnjena naprej, in mešanico vbrizgajte ob njegovo lice.
English: Vigabatrin is not recommended for use in patients with any pre-existing clinically significant visual field defect.
Slovenian: Vigabatrin se ne priporoča za uporabo pri bolnikih s kakršnim koli že prisotnim in klinično pomembnim izpadom vidnega polja.
English: For children aged 1 month to less than 7 years
Slovenian: Za otroke, stare od 1 meseca do manj kot 7 let.
English: Do not give a double dose to make up for a forgotten tablet.
Slovenian: Ne dajajte dvojnega odmerka, če ste pozabili dati prejšnjo tableto.
English: Pharmacotherapeutic group: Antiepileptics, fatty acid derivatives, ATC code: N03AG04
Slovenian: Farmakoterapevtska skupina: antiepileptiki, derivati prostih maščobnih kislin, oznaka ATC: N03AG04 Mehanizem delovanja
English: The changes in the visual field may be permanent, so it is important to detect them early to avoid progression .
Slovenian: Spremembe vidnega polja so lahko trajne, zato je za preprečevanje napredovanja pomembno, da so zaznane zgodaj.
English: If your child accidentally takes too many Kigabeq tablets, tell the doctor immediately or go to your nearest hospital or poison information centre.
Slovenian: Če otrok nenamerno vzame preveč tablet zdravila Kigabeq, to takoj povejte zdravniku ali pa obiščite najbližjo bolnišnico ali center za zastrupitve.
English: The degree of visual field constriction may be severe and this may have practical consequences for the patient.
Slovenian: Stopnja zoženja vidnega polja je lahko resna in to lahko vpliva na bolnika v praksi.
English: Therefore, vision assessment is required at baseline (no later than 4 weeks after starting treatment) and at least every 6 months while on therapy.
Slovenian: Zato je v izhodišču (najpozneje 4 tedne po začetku zdravljenja) in vsaj vsakih 6 mesecev med zdravljenjem treba oceniti vid.
English: A possible association between the risk of visual field defects and the extent of vigabatrin exposure, both in terms of daily dose (from 1 gram to more than 3 grams) and in terms of duration of treatment (maximum during the first three years) has been shown in this study.
Slovenian: V tej študiji je bila dokazana morebitna povezava med tveganjem za izpade vidnega polja in obsegom izpostavljenosti vigabatrinu, tako glede na dnevni odmerek (od 1 grama do več kot 3 grame) kot glede na trajanje zdravljenja
English: Kigabeq should not be used in combination with other medicines that may have side effects related to the eye.
Slovenian: Zdravilo Kigabeq se ne sme uporabljati v kombinaciji z drugimi zdravili, ki imajo lahko neželene učinke na oko.
English: Number of tablets (strength) Morning
Slovenian: Število tablet (jakost) zjutraj
English: Subsequent dosing can be titrated by 25 mg/kg/day increments every 3 days up to the maximum recommended dose of 150 mg/kg/day.
Slovenian: Naknadno odmerjanje je mogoče postopno povečevati za 25 mg/kg/dan vsake 3 dni do največjega priporočenega odmerka 150 mg/kg/dan.
English: Because both tablet strengths (100 mg and 500 mg) can be used concomitantly there may be confusion between the tablets or tablet halves administered with a risk of incorrect dosing.
Slovenian: Ker je mogoče obe jakosti tablet (100 mg in 500 mg) uporabljati sočasno, je mogoče tableti zamešati ali pa dajati polovice tablet ob tveganju nepravilnega odmerjanja.
English: When the tablets are fully disintegrated, the whole content of solution should be administered straight away to the child directly from the drinking glass.
Slovenian: Ko se tablete popolnoma razkrojijo, je treba otroku takoj dati vso vsebino raztopine neposredno iz kozarca.
English: Vigabatrin is eliminated via renal excretion with a terminal half-life of 5-8 hours.
Slovenian: Izločanje Vigabatrin se izloča prek ledvic, pri čemer je končna razpolovna doba 5-8 ur.
English: If the decision to continue treatment is made, consideration should be given to more frequent follow-up (perimetry) in order to detect progression or sight threatening defects.
Slovenian: Če je sprejeta odločitev o nadaljevanju zdravljenja, je treba za zaznavanje napredovanja ali izpadov, ki ogrožajo vid, premisliti o pogostejših kontrolnih pregledih (perimetriji).
English: It is used to treat infantile spasms (West's syndrome) or, together with other epilepsy medicines to treat partial epilepsy that is not controlled well enough with current treatment.
Slovenian: Uporablja se za zdravljenje infantilnih spazmov (Westovega sindroma) ali skupaj z drugimi zdravili za epilepsijo za zdravljenje delne epilepsije, ki s trenutnim zdravljenjem ni dovolj dobro nadzorovana.
English: Vigabatrin is widely distributed with an apparent volume of distribution slightly greater than total body water.
Slovenian: Vigabatrin se v veliki meri porazdeli z navideznim volumnom porazdelitve, ki je nekoliko večji od skupne količine vode v telesu.
English: • If the child cannot swallow, the mixture can be given through a gastric tube, using a suitable syringe.
Slovenian: • Če otrok ne more požirati, je mešanico mogoče s primerno brizgo dati prek gastrične sonde.
English: ORPHELIA Pharma SAS 85 boulevard Saint-Michel 75005 PARIS France
Slovenian: ORPHELIA Pharma SAS 85 boulevard Saint-Michel 75005 Pariz
English: These phenomena may also be the consequence of an overdose, a decrease in plasma concentrations of concomitant antiepileptic treatment, or a paradoxical effect.
Slovenian: Ti pojavi so lahko tudi posledica prevelikega odmerka, zmanjšanja plazemskih koncentracij pri sočasnem zdravljenju z zdravili proti epilepsiji ali paradoksalnega učinka.
English: The assessment must be continued 6 to 12 months after the discontinuation of therapy.
Slovenian: Ocenjevanje je treba nadaljevati od 6 do 12 mesecev po prekinitvi zdravljenja.
English: Kigabeq has major influence on the ability to perform hazardous activities.
Slovenian: Zdravilo Kigabeq pomembno vpliva na izvajanje nevarnih dejavnosti.
English: If your child has kidney problems, the doctor may prescribe a smaller dose.
Slovenian: Če ima otrok težave z ledvicami, lahko zdravnik predpiše manjši odmerek.
English: Tablets are disintegrated in approximately 5 or 10 ml of water and the resulting solution is introduced into the tube using an adapted syringe.
Slovenian: Tablete je treba razkrojiti v približno 5 ali 10 ml vode, raztopino, ki nastane, pa je treba s prilagojeno brizgo vliti v cevko.
English: The retinal changes in albino rats were characterised as focal or multifocal disorganisation of the outer nuclear layer while the other layers of retina were not affected.
Slovenian: Spremembe mrežnice pri podganah z albinizmom so bile opredeljene kot fokalna ali multifokalna neorganiziranost zunanje jedrne plasti mrežnice, druge plasti mrežnice pa niso bile prizadete.
English: These patients should be monitored closely for undesirable effects such as sedation and confusion (see section 4.2).
Slovenian: Te bolnike je treba skrbno spremljati glede neželenih učinkov, kot sta sedacija in zmeda (glejte poglavje 4.2).
English: No metabolites have been identified in plasma.
Slovenian: V plazmi niso odkrili presnovkov.
English: Perimetry is seldom possible in children less than 9 years of developmental age.
Slovenian: Pri otrocih, ki so razvojno mlajši od 9 let, je perimetrijo redko mogoče opraviti.
English: As routine MRI surveillance of this paediatric population is not recommended, the frequency of MRI abnormalities cannot be reliably estimated from the available data.
Slovenian: Ker rutinski nadzor te pediatrične populacije s slikanjem MRI ni priporočljiv, pogostnosti nepravilnosti pri slikanju z magnetno resonanco iz razpoložljivih podatkov ni mogoče zanesljivo oceniti.
English: If the doctor decides to stop the treatment you will be advised to gradually reduce the dose.
Slovenian: Če se zdravnik odloči, da bo ustavil zdravljenje, vam bo svetovano, da odmerek postopno zmanjšate.
English: Rarely seen events include suicide attempts, encephalopathy and retinal disorders.
Slovenian: Redko opaženi dogodki vključujejo poskuse samomora, encefalopatijo in bolezni mrežnice.
English: If you see unusual movements in your child, tell your child's doctor who may change the treatment.
Slovenian: Če pri svojem otroku opazite nenavadne gibe, to povejte njegovemu zdravniku, ki lahko spremeni zdravljenje.
English: Vigabatrin may lead to a decrease in measured plasma activity of alanine aminotransferase (ALT) and to a lesser extent, aspartate aminotransferase (AST).
Slovenian: Vigabatrin lahko povzroči zmanjšanje plazemske aktivnosti alanin aminotransferaze (ALT) in v manjši meri aspartat aminotransferaze (AST).
English: Vigabatrin increases the concentration of GABA, the major inhibitory neurotransmitter in the brain.
Slovenian: Vigabatrin poveča koncentracijo GABA, glavnega zaviralnega živčnega prenašalca.
English: The doctor works out the dose individually for your child, taking account of the child's body weight.
Slovenian: Odmerek določi zdravnik posebej za vašega otroka, pri čemer upošteva otrokovo telesno maso.
English: Do not stop suddenly as this may cause your child's seizures to occur again.
Slovenian: Dajanja zdravila ne prekinite nenadoma, saj se lahko sicer pri otroku znova pojavijo epileptični napadi.
English: As vigabatrin is neither metabolised, nor protein bound and is not an inducer of hepatic cytochrome P450 metabolising-enzymes, interactions with other medicinal products are unlikely.
Slovenian: Ker se vigabatrin ne presnavlja in ne veže na beljakovine ter ni induktor encimov, ki presnavljajo jetrni citokrom P450, je medsebojno delovanje z drugimi zdravili malo verjetno.
English: Plasma and cerebrospinal fluid concentrations are linearly related to dose over the recommended dose range.
Slovenian: Plazemske koncentracije in koncentracije cerebrospinalne tekočine so linearno povezane z odmerkom, ki je višji od priporočenega razpona odmerka.
English: Worsening of visual field loss may continue after stopping treatment.
Slovenian: Izguba vidnega polja se lahko po zaustavitvi zdravljenja poslabša.
English: Chronic treatment with vigabatrin may be associated with a slight decrease in haemoglobin which rarely attains significance.
Slovenian: Kronično zdravljenje z vigabatrinom je lahko povezano z rahlim znižanjem hemoglobina, ki je redko pomembno.
English: Maintenance recommendations in relation to bodyweight are: Bodyweight:
Slovenian: Priporočeni vzdrževalni odmerki glede na telesno maso so:
English: Food administration does not alter the extent of vigabatrin absorption.
Slovenian: Uživanje hrane ne spremeni obsega absorpcije vigabatrina.
English: There is no relevant use of Kigabeq in neonates (below 27 days of age) in the indication “infantile spasms” and in children and adolescents above 7 years of age in the indication “resistant partial epilepsy” (focal onset seizures).
Slovenian: Zdravilo Kigabeq ni namenjeno za uporabo pri novorojenčkih (starih manj kot 27 dni) za indikacijo „infantilnih spazmov‟ ter pri otrocih in mladostnikih, starejših od 7 let, za indikacijo „rezistentna delna epilepsija‟ (napadi žariščnega izvora).
English: Look for symptoms suggestive of such thoughts: disturbed sleep, loss of appetite or weight, isolation, loss of interest for favorite activities.
Slovenian: Bodite pozorni na simptome, ki namigujejo na takšne misli: moten spanec, izguba apetita ali telesne mase, izolacija, izguba zanimanja za priljubljene dejavnosti.
English: Blood and lymphatic system disorders anaemia
Slovenian: Bolezni krvi in limfatičnega sistema anemija
English: However, during controlled clinical studies, a gradual reduction of 16-33% in the plasma concentration of phenytoin has been observed.
Slovenian: Vendar so med kontroliranimi kliničnimi študijami opazili postopno zmanjšanje plazemske koncentracije fenitoina, ki je znašalo 16-33 %.
English: Do not stop giving this medicine without talking to your child's doctor.
Slovenian: Zdravila ne prenehajte dajati, ne da bi se o tem posvetovali z otrokovim zdravnikom.
English: The assessment must be continued 6 to 12 months after the discontinuation of therapy (see Visual Field Defects).
Slovenian: Ocenjevanje je treba nadaljevati od 6 do 12 mesecev po prekinitvi zdravljenja (glejte poglavje o izpadih vidnega polja).
English: If control of epilepsy is not clinically significantly improved after an adequate treatment course, vigabatrin treatment should be discontinued.
Slovenian: Če nadzor nad epilepsijo po ustreznem ciklu zdravljenja klinično ni pomembno boljši, je treba zdravljenje z vigabatrinom prekiniti.
English: Special attention should be paid to the tablet size to correctly identify the strength.
Slovenian: Za pravilno ugotavljanje jakosti je treba posebno pozornost nameniti velikosti tablete.
English: VFD may not be detected until it is severe and undetected moderate defects may affect child integrity.
Slovenian: Lahko se zgodi, da izpad vidnega polja ni zaznan, dokler ni resen, nezaznani blagi izpadi pa lahko vplivajo na otrokovo celovitost.
English: The effectiveness of haemodialysis in the treatment of vigabatrin overdose is unknown.
Slovenian: Učinkovitost hemodialize pri zdravljenju prevelikega odmerka vigabatrina ni znana.