natgillin/translations-raw huggingface dataset:
In addition, the medicine has known side effects that affect patients' quality of life. 
Poleg tega ima to zdravilo znane neželene učinke, ki vplivajo na kakovost življenja bolnikov.
Sutent is a cancer medicine currently authorised for treating the following cancers: 
Zdravilo Sutent je zdravilo za zdravljenje raka, ki je trenutno odobreno za zdravljenje naslednjih vrst raka:
Patients were treated for around a year and the study looked at how long it took for the cancer to come back (disease-free survival). 
Bolnike so zdravili približno eno leto, v študiji pa so proučevali, kako dolgo je trajalo, da se je rak ponovil (preživetje brez ponovitve bolezni).
This means that it blocks specific enzymes known as protein kinases that are involved in the growth and spread of cancer cells and the development of new blood vessels supplying them. 
To pomeni, da zavira specifične encime, imenovane protein kinaze, ki sodelujejo pri rasti in širjenju rakavih celic ter razvoju novih krvnih žil, ki jih oskrbujejo.
The company had requested a re-examination of the negative opinion, but this re-examination had not yet finished when the company withdrew the application. 
Družba je zahtevala ponovno presojo negativnega mnenja, ki pa še ni bila zaključena, ko se je družba odločila za umik vloge.
When data from patients at highest risk of cancer returning were looked at separately, the benefits of Sutent were still not convincing. 
Tudi ko so bili podatki bolnikov z največjim tveganjem za ponovitev raka obravnavani ločeno, koristi zdravila Sutent še vedno niso bile prepričljive.
What is Sutent? 
Kaj je zdravilo Sutent?
In its letter notifying the Agency of the withdrawal of application, the company stated that it was withdrawing because the data provided do not allow the CHMP to conclude that the benefit outweighs the risks. 
Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da jo umika, ker predloženi podatki odboru CHMP ne omogočajo zaključka, da koristi odtehtajo tveganja.
• metastatic renal cell carcinoma (kidney cancer that has spread to other parts of the body). 
• metastatskega karcinoma ledvičnih celic (raka ledvic, ki se je razširil na druge dele telesa).
The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Sutent. 
Družba je odbor CHMP obvestila, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Sutent.
What is happening with Sutent for treatment in other uses? 
Kaj to pomeni za nadaljnjo uporabo zdravila Sutent za druge uporabe?
On 26 June 2018, Pfizer Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application to extend use of Sutent to the treatment of patients at high risk of kidney cancer returning after surgery. 
Družba Pfizer Limited je 26. junija 2018 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za razširitev uporabe zdravila Sutent na zdravljenje bolnikov z velikim tveganjem za ponovitev raka ledvic po kirurškem posegu.
There are no consequences for Sutent in its authorised uses. 
Umik vloge nima posledic za odobrene uporabe zdravila Sutent.
• gastrointestinal stromal tumour (a cancer of the stomach and bowel); 
• gastrointestinalnega stromalnega tumorja (raka želodca in črevesja);
What was Sutent expected to be used for? 
Za kaj naj bi se zdravilo Sutent uporabljalo?
The CHMP considered that the evidence that Sutent delays the return of the cancer was not convincing. 
Odbor CHMP je presodil, da dokazi, da zdravilo Sutent odloži ponovitev raka, niso bili prepričljivi.
The company presented results of a main study comparing Sutent with placebo (a dummy treatment) in 615 patients at high risk of their kidney cancer coming back after surgery. 
Družba je predstavila rezultate glavne študije, v kateri so zdravilo Sutent primerjali s placebom (zdravilom brez učinkovine) pri 615 bolnikih z velikim tveganjem za ponovitev raka ledvic po kirurškem posegu.
By blocking these enzymes, Sutent can reduce the growth and spread of the cancer and cut off the blood supply that keeps cancer cells growing. 
Zdravilo Sutent lahko z njihovim zaviranjem upočasni rast in širjenje raka ter prekine oskrbo s krvjo, ki omogoča rast rakavih celic.
Sutent was expected to be used to delay or prevent the return of kidney cancer in patients who have had surgery and are at high risk of their cancer coming back. 
Zdravilo Sutent naj bi se uporabljalo za odložitev ali preprečitev ponovitve raka ledvic pri bolnikih, ki so bili operirani in pri katerih obstaja veliko tveganje za ponovitev raka.
• pancreatic neuroendocrine tumours (tumours of the hormone-producing cells in the pancreas); 
• nevroendokrinega tumorja trebušne slinavke (tumorja celic v trebušni slinavki, ki tvorijo hormone);
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Sutent in the treatment of patients at high risk of kidney cancer returning after surgery did not outweigh its risks. 
Zato je odbor CHMP ob umiku vloge menil, da koristi zdravila Sutent pri zdravljenju bolnikov z velikim tveganjem za ponovitev raka ledvic po kirurškem posegu ne odtehtajo z njim povezanih tveganj.
Based on the review of the data, at the time of the withdrawal, the CHMP had given a negative opinion, recommending that the marketing authorisation for Sutent not be changed to add the treatment of patients at high risk of kidney cancer returning after surgery. 
Odbor CHMP je na podlagi pregleda podatkov ob umiku vloge izrazil negativno mnenje in priporočil, da se dovoljenje za promet z zdravilom Sutent ne spremeni tako, da bi dodali zdravljenje bolnikov z velikim tveganjem za ponovitev raka ledvic po kirurškem posegu.
How does Sutent work? 
Kako zdravilo Sutent deluje?
Never change the dose yourself. 
Odmerka nikoli ne spreminjajte sami.
After first opening: 100 days 
Po prvem odprtju: 100 dni
The usual supportive measures should be employed. 
Izvesti je treba običajne podporne ukrepe.
There is no specific antidote. 
Ni specifičnega antidota.
If it is almost time for the next dose, just give one dose. 
Če je že skoraj čas za naslednji odmerek, dajte le en odmerek.
Children (from 8 to 12 years old) 
Otroci (stari od 8 do 12 let)
• Wait until the tablet has broken down completely. 
• Počakajte, dokler se tableta popolnoma ne razgradi.
- Observed at inclusion - Observed at first conclusive evaluation - Observed at last conclusive evaluation 
- Opaženo ob vključitvi - Opaženo ob prvem zaključnem vrednotenju - Opaženo ob zadnjem zaključnem vrednotenju
The maximum recommended dose should not be exceeded. 
Največji priporočeni odmerek ne sme biti presežen.
Date of first authorisation: 20 September 2018 
Datum pridobitve dovoljenja za promet: 20. septembra 2018
Frequencies found in an open clinical study are presented in section 4.8. 
Pogostnosti, ugotovljene v odprti klinični študiji, so predstavljene v poglavju 4.8.
Time to reach maximum plasma concentrations (tmax) is approximately 1 hour. 
Čas do doseganja najvišjih plazemskih koncentracij (tmax) je približno 1 uro.
Such patients may respond to a lower maintenance dose. 
Takšni bolniki se lahko odzovejo na nižji vzdrževalni odmerek.
In the monkey these lesions are minimal or equivocal. 
Pri opicah so te lezije minimalne ali nejasne.
Males may be at greater risk than females. 
Tveganje je pri moških lahko večje kot pri ženskah.
The following table presents the main findings at inclusion and the first and last conclusive evaluations in the evaluable population (n=524): 
V spodnji preglednici so predstavljene glavne ugotovitve ob vključitvi ter prve in zadnje zaključne ocene v populaciji, ki jo je mogoče ovrednotiti (n = 524):
Oral and gastric use. 
Peroralna in gastrična uporaba.
The doctor will adjust the dose during treatment as necessary. 
Zdravnik bo med zdravljenjem po potrebi prilagodil odmerek.
Measures to remove unabsorbed medicinal product should be considered. 
Razmisliti je treba o ukrepih za odstranjevanje neabsorbiranega zdravila.
In a few patients, the lesion resolved despite continued use. 
Pri nekaj bolnikih je bila lezija odpravljena kljub nadaljevanju uporabe.
Very common: excitation, agitation 
Zelo pogosti: razburjenje, vznemirjenje
Therefore, vigabatrin should only be used after careful benefit/ risk assessment compared with alternatives. 
Zato je treba vigabatrin uporabljati le po skrbni presoji koristi/tveganja v primerjavi z drugimi možnostmi.
Suicidal ideation and behaviour 
Samomorilne misli in vedenje
Binding to plasma proteins is negligible. 
Vezava na plazemske beljakovine je zanemarljiva.
How to give this medicine 
Kako dajati zdravilo
This efficacy is particularly marked in patients with seizures of partial origin. 
Ta učinkovitost je posebej izražena pri bolnikih z napadi delnega izvora.
The tablet can be cut into equal halves. 
Tablete je mogoče prerezati na enaki polovici.
This is normal and the cloudiness is because the tablet contains some non-active ingredients that do not dissolve completely 
To je normalno, motnost pa nastane zato, ker tableta vsebuje nekaj neaktivnih sestavin, ki se ne raztopijo v celoti.
These responses are delayed and reduced beyond the normal limits. 
Ti odzivi so zakasnjeni in zmanjšani bolj, kot je običajno.
The mechanism of this effect is not known and the available data do not exclude the possibility of an increased risk for vigabatrin. 
Mehanizem tega učinka ni znan in razpoložljivi podatki ne vključujejo možnosti povečanega tveganja pri vigabatrinu.
In the study above, in post-marketing experience, and in published literature reports, these changes generally resolved with discontinuation of treatment. 
V zgornji študiji, pri izkušnjah iz dejavnosti v obdobju trženja in v objavljenih poročilih v literaturi so bile te spremembe s prekinitvijo zdravljenja običajno odpravljene.
Centre Spécialités Pharmaceutiques 76-78 avenue du Midi 63800 Cournon d'Auvergne France 
Centre Spécialités Pharmaceutiques 76-78 avenue du Midi 63800 Cournon d'Auvergne Francija
If you forget to give your child a dose, give the dose as soon as you remember. 
Če otroku pozabite dati odmerek, ga dajte takoj, ko se spomnite.
For instructions on dissolution and handling of the medicinal product before administration, see section 6.6. 
Za navodila glede raztapljanja zdravila in ravnanja z njim pred dajanjem glejte poglavje 6.6.
The exact nature of this interaction is presently not understood, however, in the majority of cases it is unlikely to be of therapeutic significance. 
Prava narava tega medsebojnega delovanja trenutno ni znana, vendar je v večini primerov malo verjetno, da je pomembna za zdravljenje.
Do not use this medicine after the expiry date which is stated on the carton and the bottle. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in plastenki.
Use only water to prepare solution. 
Za pripravo raztopine uporabljajte le vodo.
Currently, there is no established method to diagnose or exclude visual field defects in children in whom a standardised perimetry cannot be performed. 
Trenutno ni nobene uveljavljene metode za diagnosticiranje ali izključitev izpadov vidnega polja pri otrocih, pri katerih ni mogoče opraviti standardizirane perimetrije.
Vigabatrin can cause permanent vision loss. 
Vigabatrin lahko povzroči trajno izgubo vida.
They are not specific to the paediatric population. 
Ti se ne nanašajo le na pediatrično populacijo.
This medicine has been prescribed for your child. Do not pass it on to others. 
- Zdravilo je bilo predpisano vašemu otroku in ga ne smete dajati drugim.
Adjustment of dose should be considered. 
Razmisliti je treba o prilagoditvi odmerka.
Vigabatrin should be gradually withdrawn under close medical supervision. 
Vigabatrin je treba ukiniti postopoma pod strogim zdravniškim nadzorom.
The tablets are scored on one side and can be divided into equal doses. 
Tablete imajo na eni strani zarezo in jih je mogoče razdeliti na enake odmerke.
to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). 
≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznani (iz razpoložljivih podatkov jih ni mogoče oceniti).
The risks of treatment must be very carefully weighed against possible benefit in children. 
Pri otrocih je treba zelo skrbno pretehtati tveganje zdravljenja glede na morebitne koristi.
When reported, the most common symptoms included drowsiness or coma. 
Kadar so poročali o simptomih, so najpogostejši simptomi vključevali zaspanost ali komo.
White oval tablets. 
Bele ovalne tablete.
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. 
Običajni vzorec na podlagi razpoložljivih podatkov je koncentrična zožitev vidnega polja obeh oči, ki je v splošnem nazalno bolj izrazita kot temporalno.
Risk of medication error 
Tveganje napake pri uporabi zdravila
However, do not decrease the dose without first talking to your child's doctor. 
Vendar odmerka ne zmanjšujte, ne da bi se najprej posvetovali z otrokovim zdravnikom.
This medicine should be used within 100 days after first opening. 
To zdravilo morate porabiti v 100 dneh po odprtju plastenke.
This visual field loss may be severe and permanent, so it must be detected early to avoid progression. 
Taka izguba vidnega polja je lahko resna in trajna, zato jo je treba zaznati zgodaj, da se prepreči napredovanje.
Therefore, patients should be monitored for signs of suicidal ideation and behaviour, and appropriate treatment should be considered. 
Zato je treba bolnike spremljati glede znakov in simptomov samomorilnih misli in vedenja ter razmisliti o ustreznem zdravljenju.
The duration of the effect of the medicinal product is dependent on the GABA transaminase re-synthesis rate. 
Trajanje učinka zdravila je odvisno od hitrosti ponovne sintetizacije transaminaze GABA.
Special care should be taken with young patients cycling, climbing or performing any other hazardous activity. 
Posebna skrb je potrebna pri mladih bolnikih, ko kolesarijo, plezajo ali izvajajo kakršno koli drugo nevarno dejavnost.
Possible signs of overdose include drowsiness or reduced level of consciousness. 
Možni znaki prevelikega odmerjanja vključujejo zaspanost ali zmanjšano raven zavesti.
Frequency and severity have only been indirectly characterised in this population on the presence of electroretinogram or visual evoked potential anomalies. 
Pogostnost in resnost sta bili pri tej populaciji opredeljeni le posredno z elektroretinogramom ali z vizualno izzvanimi potencialnimi nepravilnostmi.
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 
zelo pogosti (≥ 1/10); pogosti (od ≥ 1/100 do < 1/10); občasni (od ≥ 1/1.000 do < 1/100); redki (od
Interference with serological testing 
Motnje serološkega testiranja
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. 
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.
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). 
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).
Approximately 70% of a single oral dose was recovered as unchanged drug in the urine in the first 24 hours post-dose. 
Približno 70 % posameznega peroralnega odmerka je bilo v prvih 24 urah v urinu v obliki nespremenjenega zdravila.
Undesirable effects ranked under headings of frequency are listed below, using the following convention: 
Neželeni učinki, razvrščeni po skupinah glede na pogostnost, so spodaj našteti po naslednjem dogovoru:
This leaflet was last revised in {month YYYY}. 
Navodilo je bilo nazadnje revidirano dne (mesec LLLL).
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 
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
In the central visual field (within 30 degree of eccentricity), frequently an annular nasal defect is seen. 
V centralnem vidnem polju (znotraj 30-stopinjske ekscentričnosti) je pogosto mogoče opaziti obročast nazalni izpad.
Neurologic and psychiatric conditions 
Nevrološka in psihiatrična stanja
Since no stability studies have been performed with other solvents than water, for preparing oral solution only water should be used. 
Ker ni izvedenih nobenih študij stabilnosti z drugimi topili, razen z vodo, je treba za pripravo peroralne raztopine uporabiti vodo.
Mean terminal half-life of vigabatrin was about 7.5 hours in neonates, 5.7 hours in infants and 5.5 hours in children. 
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.
Most patients with perimetry-confirmed defects had not previously spontaneously noticed any symptoms, even in cases where a severe defect was observed in perimetry. 
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.
This takes less than a minute but you can speed it up by stirring the mixture gently by hand 
To traja manj kot minuto, lahko pa ta čas še skrajšate, tako da mešanico nežno ročno mešate.
The benefit/risk ratio of vigabatrin should be evaluated on an individual patient basis. 
Razmerje med koristmi in tveganji vigabatrina je treba ovrednotiti pri vsakem posameznem bolniku posebej.
Studies with vigabatrin revealed no evidence of mutagenic or carcinogenic effects. 
Študije vigabatrina niso odkrile dokazov o mutagenih ali karcinogenih učinkih.
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. 
Otrokovega zdravnika obvestite tudi, če je vaš otrok opravil ali bo opravljal laboratorijske teste, saj lahko to zdravilo povzroča neobičajne rezultate.
Fertility studies in rats have shown no effect on male and female fertility (see section 5.3). 
V študijah plodnosti pri podganah niso dokazali nobenega učinka na plodnost samcev in samic (glejte poglavje 5.3).
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. 
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.
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. 
Zato je ta neželeni učinek mogoče zanesljivo zaznati le s sistematično perimetrijo, ki je običajno mogoča le pri bolnikih,
Visual field defect with non-identified aetiology: 
Izpad vidnega polja brez opredeljene etiologije:
Tell your child's doctor if the child is taking, has recently taken or might take any other medicines. 
Obvestite otrokovega zdravnika, če otrok jemlje, je pred kratkim jemal ali pa bo morda začel jemati katero koli drugo zdravilo.
The following table gives the number of Kigabeq tablets to give to your child according to the dose prescribed by your child's doctor. 
V naslednji tabeli je podano število tablet zdravila Kigabeq za dajanje vašemu otroku v skladu z odmerkom, ki ga je predpisal otrokov zdravnik.
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. 
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.
Visual field testing should continue at 6 month intervals for the whole duration of treatment. 
Testiranje vidnega polja je treba nadaljevati v 6-mesečnih časovnih presledkih v celotnem obdobju zdravljenja.
Severe cases are potentially disabling. 
Resni primeri lahko vodijo v invalidnost.
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. 
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 %.
• 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 
• 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.
Vigabatrin is not recommended for use in patients with any pre-existing clinically significant visual field defect. 
Vigabatrin se ne priporoča za uporabo pri bolnikih s kakršnim koli že prisotnim in klinično pomembnim izpadom vidnega polja.
For children aged 1 month to less than 7 years 
Za otroke, stare od 1 meseca do manj kot 7 let.
Do not give a double dose to make up for a forgotten tablet. 
Ne dajajte dvojnega odmerka, če ste pozabili dati prejšnjo tableto.
Pharmacotherapeutic group: Antiepileptics, fatty acid derivatives, ATC code: N03AG04 
Farmakoterapevtska skupina: antiepileptiki, derivati prostih maščobnih kislin, oznaka ATC: N03AG04 Mehanizem delovanja
The changes in the visual field may be permanent, so it is important to detect them early to avoid progression . 
Spremembe vidnega polja so lahko trajne, zato je za preprečevanje napredovanja pomembno, da so zaznane zgodaj.
If your child accidentally takes too many Kigabeq tablets, tell the doctor immediately or go to your nearest hospital or poison information centre. 
Če otrok nenamerno vzame preveč tablet zdravila Kigabeq, to takoj povejte zdravniku ali pa obiščite najbližjo bolnišnico ali center za zastrupitve.
The degree of visual field constriction may be severe and this may have practical consequences for the patient. 
Stopnja zoženja vidnega polja je lahko resna in to lahko vpliva na bolnika v praksi.
Therefore, vision assessment is required at baseline (no later than 4 weeks after starting treatment) and at least every 6 months while on therapy. 
Zato je v izhodišču (najpozneje 4 tedne po začetku zdravljenja) in vsaj vsakih 6 mesecev med zdravljenjem treba oceniti vid.