FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Croatian: Očekivalo se da će se Sutent koristiti za odgodu ili sprječavanje ponovne pojave raka bubrega u pacijenata koji su imali operaciju i u kojih je prisutan visok rizik od ponovne pojave raka.
English: • pancreatic neuroendocrine tumours (tumours of the hormone-producing cells in the pancreas);
Croatian: • neuroendokrinih tumora gušterače (tumori stanica koji proizvode hormone u gušterači)
English: 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.
Croatian: Na temelju pregleda podataka, u trenutku povlačenja CHMP je bio dao negativno mišljenje, preporučujući da se odobrenje za stavljanje u promet lijeka Sutent ne mijenja dodavanjem liječenja bolesnika s visokim rizikom od ponovne pojave raka bubrega nakon operacije.
English: 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.
Croatian: Sukladno navedenome, CHMP je u vrijeme povlačenja smatrao kako koristi od lijeka Sutent u liječenju bolesnika s visokim rizikom od ponovne pojave raka bubrega nakon operacije ne nadmašuju s njim povezane rizike.
English: After first opening: 100 days
Croatian: Nakon prvog otvaranja: 100 dana
English: Date of first authorisation: 20 September 2018
Croatian: Datum prvog odobrenja: 20. rujna 2018
English: Never change the dose yourself.
Croatian: Nikad nemojte sami mijenjati dozu lijeka.
English: Ask your pharmacist how to throw away medicines you no longer use.
Croatian: Pitajte svojeg ljekarnika kako baciti lijekove koje više ne koristite.
English: How to give this medicine
Croatian: Kako davati ovaj lijek
English: There is no specific antidote.
Croatian: Ne postoji poseban antidot.
English: The usual supportive measures should be employed.
Croatian: Potrebno je primijeniti uobičajene mjere potpore.
English: Common Uncommon Rare Very rare Not known
Croatian: Manje često Rijetko Vrlo rijetko Nepoznato
English: • Wait until the tablet has broken down completely.
Croatian: • Pričekajte dok se tableta u potpunosti ne otopi.
English: Risk of medication error
Croatian: Rizik od medikacijskih pogrešaka
English: Always give this medicine to your child exactly as the doctor has told you.
Croatian: Uvijek dajte ovaj lijek svojem djetetu točno onako kako vam je rekao liječnik.
English: This medicine should be used within 100 days after first opening.
Croatian: Iskoristite ovaj lijek u roku od 100 dana od prvog otvaranja.
English: Ask your child's doctor to show you how to give this medicine.
Croatian: Zamolite liječnika svojeg djeteta da Vam pokaže kako davati ovaj lijek.
English: Time to reach maximum plasma concentrations (tmax) is approximately 1 hour.
Croatian: Vrijeme do postizanja najveće koncentracije u plazmi (tmax) je približno 1 sat.
English: If it is almost time for the next dose, just give one dose.
Croatian: Ako je blizu vrijeme za davanje sljedeće doze, dajte mu samo jednu dozu.
English: The maximum recommended dose should not be exceeded.
Croatian: Ne smije se prekoračiti najviša preporučena doza.
English: These responses are delayed and reduced beyond the normal limits.
Croatian: Ti odgovori kasne i ispod su granica normale.
English: Adjustment of dose should be considered.
Croatian: Treba razmotriti prilagodbu doze.
English: In the monkey these lesions are minimal or equivocal.
Croatian: U majmuna su te lezije bile minimalne ili nejasne.
English: The risks of treatment must be very carefully weighed against possible benefit in children.
Croatian: Treba vrlo pažljivo razmotriti rizike liječenja u odnosu na moguće koristi u djece.
English: Males may be at greater risk than females.
Croatian: Moguće je da su muškarci izloženi većem riziku od žena.
English: Interference with serological testing
Croatian: Interferencija sa serološkim testovima
English: Always check the label and the size of the tablets to make sure you are giving the right dose.
Croatian: Uvijek provjerite naljepnicu i veličinu tableta kako biste bili sigurni da dajete ispravnu dozu.
English: to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Croatian: 1/1000); vrlo rijetko (< 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Special attention should be paid to the tablet size to correctly identify the strength.
Croatian: Potrebno je obratiti posebnu pozornost na veličinu tableta kako bi se ispravno utvrdila jačina.
English: N=150 N=151 N=97
Croatian: N = 38 N = 47 N = 41 N = 150 N = 151 N = 97
English: Binding to plasma proteins is negligible.
Croatian: Vezanje na proteine plazme je zanemarivo.
English: Kigabeq has major influence on the ability to perform hazardous activities.
Croatian: Kigabeq značajno utječe na sposobnost izvođenja opasnih aktivnosti.
English: Do not give a double dose to make up for a forgotten tablet.
Croatian: Nemojte davati dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: If you forget to give your child a dose, give the dose as soon as you remember.
Croatian: Ako ste zaboravili djetetu dati dozu lijeka, dajte mu dozu čim se sjetite.
English: Read all of this leaflet carefully before you give this medicine to your child because it contains important information.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete davati ovaj lijek svojem djetetu jer sadrži važne podatke.
English: Centre Spécialités Pharmaceutiques 76-78 avenue du Midi 63800 Cournon d'Auvergne France
Croatian: Centre Spécialités Pharmaceutiques 76-78 avenue du Midi 63800 Cournon d'Auvergne Francuska
English: The mechanism of this effect is not known and the available data do not exclude the possibility of an increased risk for vigabatrin.
Croatian: Mehanizam ovog učinka nije poznat, a dostupni podaci ne isključuju mogućnost povećanog rizika i kod vigabatrina.
English: It is important that you tell the doctor promptly if there is any change in your child's vision.
Croatian: Važno je da odmah obavijestite liječnika ako nastupe promjene u vidu Vašeg djeteta.
English: Vigabatrin can cause permanent vision loss.
Croatian: Vigabatrin može prouzročiti trajan gubitak vida.
English: They are not specific to the paediatric population.
Croatian: Ne odnose se samo na pedijatrijsku populaciju.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u popisu referentnih datuma Unije (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: This leaflet was last revised in {month YYYY}.
Croatian: Ova uputa je zadnji put revidirana u {mjesec GGGG}.
English: The exact nature of this interaction is presently not understood, however, in the majority of cases it is unlikely to be of therapeutic significance.
Croatian: Točna priroda te interakcije trenutačno nije poznata, ali u većini slučajeva malo je vjerojatno da bi to bilo značajno za liječenje.
English: This takes less than a minute but you can speed it up by stirring the mixture gently by hand
Croatian: Za to treba manje od jedne minute, no možete to ubrzati nježnim miješanjem smjese.
English: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000
Croatian: Vrlo često (≥1/10); često (≥1/100 i < 1/10); manje često (≥1/1000 i < 1/100); rijetko (≥1/10 000 i <
English: Vigabatrin should be gradually withdrawn under close medical supervision.
Croatian: Vigabatrin treba postupno ukidati pod strogim medicinskim nadzorom.
English: ORPHELIA Pharma SAS Teл.
Croatian: ORPHELIA Pharma SAS
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.
Croatian: Stoga se ova nuspojava može pouzdano otkriti samo sistematskom perimetrijom, koja je moguća uglavnom samo u bolesnika u razvojnoj dobi iznad devet godina.
English: No metabolites have been identified in plasma.
Croatian: U plazmi nisu identificirani metaboliti.
English: Measures to remove unabsorbed medicinal product should be considered.
Croatian: Treba razmotriti mjere za uklanjanje neapsorbiranog lijeka.
English: Visual Field Defects (VFD)
Croatian: Ispadi vidnog polja (VFD)
English: Suicidal ideation and behaviour
Croatian: Suicidalne misli i suicidalno ponašanje
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.
Croatian: Na temelju dostupnih podataka, uobičajeni obrazac je koncentrično sužavanje vidnog polja na oba oka, koje je uglavnom izraženije nazalno nego temporalno.
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
Croatian: 1 Medijan trajanja liječenja: 44,4 mjeseca, prosječna dnevna doza 1,48 g 2 Medijan trajanja liječenja: 20,6 mjeseci, prosječna dnevna doza 1,39 g 3 Medijan trajanja liječenja: 48,8 mjeseci, prosječna dnevna doza 2,10 g 4 Medijan trajanja liječenja: 23,0 mjeseca, prosječna dnevna doza 2,18 g
English: Tell your child's doctor if the child is taking, has recently taken or might take any other medicines.
Croatian: Obavijestite liječnika svojeg djeteta ako ono uzima, nedavno je uzelo ili bi moglo uzimati bilo koje druge lijekove.
English: Get medical advice immediately if your child has the following:
Croatian: Odmah potražite liječničku pomoć ako Vaše dijete ima sljedeće nuspojave:
English: Neurologic and psychiatric conditions
Croatian: Neurološka i psihijatrijska stanja
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).
Croatian: Bolesnici su bili podijeljeni u tri ispitne skupine: bolesnici koji su se trenutačno liječili vigabatrinom (skupina I.), bolesnici koji su prethodno bili izloženi vigabatrinu (skupina II.) i bolesnici koji nikada nisu bili izloženi vigabatrinu (skupina III.).
English: The doctor works out the dose individually for your child, taking account of the child's body weight.
Croatian: Liječnik izračunava dozu koja je prilagođena Vašem djetetu, uzimajući u obzir tjelesnu težinu djeteta.
English: Frequencies found in an open clinical study are presented in section 4.8.
Croatian: Učestalosti ustanovljene u otvorenom kliničkom ispitivanju navedene su u dijelu 4.8.
English: Do not use this medicine after the expiry date which is stated on the carton and the bottle.
Croatian: Ovaj lijek ne smije se upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i boci.
English: The tablet can be cut into equal halves.
Croatian: Tableta se može prepoloviti na jednake dijelove.
English: Approximately 70% of a single oral dose was recovered as unchanged drug in the urine in the first 24 hours post-dose.
Croatian: Otprilike 70 % jednokratne oralne doze nađeno je u urinu u obliku nepromijenjenog lijeka unutar prva 24 sata nakon doze.
English: Investigation s weight increased
Croatian: Pretrage povećana težina
English: Such patients may respond to a lower maintenance dose.
Croatian: U takvih bolesnika mogao bi se postići odgovor s nižom dozom održavanja.
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.
Croatian: Čimbenici rizika za razvoj tih reakcija uključuju višu početnu dozu od preporučene, brže povećanje doza u većim koracima no što je preporučeno i zatajenje bubrega.
English: These phenomena may also be the consequence of an overdose, a decrease in plasma concentrations of concomitant antiepileptic treatment, or a paradoxical effect.
Croatian: Te pojave mogu također biti posljedica predoziranja, smanjenja koncentracije istodobnih antiepileptičkih lijekova u plazmi ili paradoksalnog učinka.
English: Vigabatrin increases the concentration of GABA, the major inhibitory neurotransmitter in the brain.
Croatian: Vigabatrin povećava koncentraciju GABA-e, glavnog inhibitornog neurotransmitera u mozgu.
English: However, during controlled clinical studies, a gradual reduction of 16-33% in the plasma concentration of phenytoin has been observed.
Croatian: Međutim, tijekom kontroliranih kliničkih ispitivanja zabilježeno je postupno smanjenje od 16 % do 33 % plazmatske koncentracije fenitoina.
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.
Croatian: U slučaju odluke da se nastavi s liječenjem, trebalo bi razmotriti češće praćenje (perimetrija) radi otkrivanja progresije ili oštećenja koja ugrožavaju vid.
English: Currently, there is no established method to diagnose or exclude visual field defects in children in whom a standardised perimetry cannot be performed.
Croatian: Trenutačno ne postoji utvrđena metoda za dijagnozu ili isključivanje ispada vidnog polja u djece u koje se ne može provesti standardizirana perimetrija.
English: If your child accidentally takes too many Kigabeq tablets, tell the doctor immediately or go to your nearest hospital or poison information centre.
Croatian: Ako Vaše dijete slučajno uzme previše tableta Kigabeq, smjesta obavijestite liječnika ili otiđite u najbližu bolnicu ili centar za kontrolu otrovanja.
English: The magnitude of suppression for ALT has been reported to vary between 30% and 100%.
Croatian: Prijavljena razina supresije ALT-a kretala se od 30 % do 100 %.
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.
Croatian: U okviru ovog ispitivanja dokazano je da postoji moguća povezanost između rizika od ispada vidnog polja i razine izloženosti vigabatrinu u smislu dnevne doze (od 1 g do više od 3 g) i trajanja liječenja (u najvećoj mjeri tijekom prve tri godine).
English: Fertility studies in rats have shown no effect on male and female fertility (see section 5.3).
Croatian: U ispitivanjima plodnosti provedenima na štakorima nije opažen utjecaj na plodnost u mužjaka i ženki (vidjeti dio 5.3).
English: For instructions on dissolution and handling of the medicinal product before administration, see section 6.6.
Croatian: Za upute o otapanju lijeka i rukovanju lijekom prije primjene vidjeti dio 6.6.
English: Pharmacotherapeutic group: Antiepileptics, fatty acid derivatives, ATC code: N03AG04
Croatian: Farmakoterapijska skupina: Antiepileptici, derivati masnih kiselina, ATK oznaka: N03AG04 Mehanizam djelovanja
English: Possible signs of overdose include drowsiness or reduced level of consciousness.
Croatian: Mogući znakovi predoziranja uključuju omamljenost ili smanjenu razinu svijesti.
English: Patients with myoclonic seizures may be particularly susceptible to this effect.
Croatian: Bolesnici s miokloničkim napadajima mogu biti osobito podložni tom učinku.
English: Suicidal ideation and behaviour have been reported in patients treated with antiepileptic medicinal products in several indications.
Croatian: Suicidalne misli i suicidalno ponašanje zabilježeni su u bolesnika liječenih antiepileptičkim lijekovima u nekoliko indikacija.
English: Rare side effects (may affect up to 1 in 1,000 people) serious allergic reaction, which causes swelling of the face or throat.
Croatian: Rijetke nuspojave (mogu se javiti u do 1 na 1 000 osoba) teške alergijske reakcije koje uzrokuju oticanje lica ili grla.
English: The duration of the effect of the medicinal product is dependent on the GABA transaminase re-synthesis rate.
Croatian: Trajanje učinka lijeka ovisi o brzini ponovne sinteze GABA transaminaze.
English: Kigabeq should not be used in combination with other medicines that may have side effects related to the eye.
Croatian: Kigabeq se ne smije primjenjivati u kombinaciji s drugim lijekovima koji mogu imati nuspojave povezane s očima.
English: In the study above, in post-marketing experience, and in published literature reports, these changes generally resolved with discontinuation of treatment.
Croatian: Na temelju navedenog ispitivanja, iskustva nakon stavljanja lijeka u promet i izvješća objavljenih u literaturi ustanovljeno je da su te promjene uglavnom nestale nakon prekida liječenja.
English: The changes in the visual field may be permanent, so it is important to detect them early to avoid progression .
Croatian: Promjene vidnog polja mogu biti trajne, stoga je važno da se otkriju u ranoj fazi kako bi se izbjegla progresija.
English: The doctor will adjust the dose during treatment as necessary.
Croatian: Liječnik će tijekom liječenja prema potrebi prilagoditi dozu lijeka.
English: Nearly half of the cases involved multiple drug ingestions.
Croatian: U gotovo polovici slučajeva radilo se o ingestiji više lijekova.
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.
Croatian: Pričekajte dok se tableta/e u potpunosti ne otopi/e; tablete se uglavnom otope za manje od jedne minute, no otapanje se može ubrzati nježnim miješanjem oralne otopine.
English: When provided, doses were most commonly between 7.5 to 30 g; however, ingestions up to 90 g have been reported.
Croatian: Zabilježene doze najčešće su bile u rasponu od 7,5 g do 30 g, no prijavljene su ingestije do 90 g.
English: Vigabatrin is widely distributed with an apparent volume of distribution slightly greater than total body water.
Croatian: Vigabatrin se široko distribuira, s prividnim volumenom distribucije koji je nešto veći od ukupnog volumena vode u tijelu.
English: If the doctor decides to stop the treatment you will be advised to gradually reduce the dose.
Croatian: Ako liječnik odluči prekinuti liječenje, savjetovat će Vam da postupno smanjujete dozu lijeka.
English: What Kigabeq is and what it is used for
Croatian: Što je Kigabeq i za što se koristi
English: Patients (and caregivers of patients) should be advised to seek medical advice immediately should signs of suicidal ideation or behaviour emerge.
Croatian: Bolesnicima (i njegovateljima tih bolesnika) treba savjetovati da odmah potraže savjet liječnika ako se pojave znakovi suicidalnih misli ili suicidalnog ponašanja.
English: For children aged 1 month to less than 7 years
Croatian: Za djecu u dobi od navršenog jednog mjeseca do manje od sedam godina
English: 0.5 x 100 mg tablet morning 0.5 x 100 mg tablet evening 0.5 x 100 mg tablet morning 1 x 100 mg tablet evening 1 x 100 mg tablet morning 1 x 100 mg tablet evening 1 x 100 mg tablet morning 1.5 x 100 mg tablet evening 1.5 x 100 mg tablet morning 1.5 x 100 mg tablet evening 1.5 x 100 mg tablet morning 2 x 100 mg tablet evening 2 x 100 mg tablet morning 2 x 100 mg tablet evening 2.5 x 100 mg tablet morning 2.5 x 100 mg tablet evening 3 x 100 mg tablet morning 3 x 100 mg tablet evening 3.5 x 100 mg tablet morning 3.5 x 100 mg tablet evening 3.5 x 100 mg tablet morning 4 x 100 mg tablet evening 4.5 x 100 mg tablet morning 4.5 x 100 mg tablet evening 1 x 500 mg tablet morning 1 x 500 mg tablet evening 1 x 500 mg tablet morning 1 x 500 mg and 1 x 100 mg tablet evening 30 1 x 500 mg and 1 x 100 mg tablet morning 1 x 500 mg and 1 x 100 mg tablet evening
Croatian: 0,5 x tableta od 100 mg ujutro 0,5 x tableta od 100 mg navečer 0,5 x tableta od 100 mg ujutro 1 x tableta od 100 mg navečer 1 x tableta od 100 mg ujutro 1 x tableta od 100 mg navečer 1 x tableta od 100 mg ujutro 1,5 x tableta od 100 mg navečer 1,5 x tableta od 100 mg ujutro 1,5 x tableta od 100 mg navečer 1,5 x tableta od 100 mg ujutro 2 x tableta od 100 mg navečer 2 x tableta od 100 mg ujutro 2 x tableta od 100 mg navečer 2,5 x tableta od 100 mg ujutro 2,5 x tableta od 100 mg navečer 3 x tableta od 100 mg ujutro 3 x tableta od 100 mg navečer 3,5 x tableta od 100 mg ujutro 3,5 x tableta od 100 mg navečer 3,5 x tableta od 100 mg ujutro 4 x tableta od 100 mg navečer 4,5 x tableta od 100 mg ujutro 4,5 x tableta od 100 mg navečer 1 x tableta od 500 mg ujutro 1 x tableta od 500 mg navečer 1 x tableta od 500 mg ujutro 1 x tableta od 500 mg i 1 x tableta od
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.
Croatian: U okviru retrospektivnog epidemiološkog ispitivanja koje je obuhvatilo dojenčad s infantilnim spazmima (N = 205), prevalencija tih promjena u bolesnika liječenih vigabatrinom bila je 22 % nasuprot 4 % u bolesnika koji su primali druge oblike liječenja.
English: If your child has kidney problems, the doctor may prescribe a smaller dose.
Croatian: Ako Vaše dijete ima problema s bubrezima, liječnik će možda propisati manju dozu.
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.
Croatian: Farmakokinetička svojstva vigabatrina ispitivana su u skupinama od šestero novorođenčadi (u dobi od 15 do 26 dana), šestero dojenčadi (u dobi od 5 do 22 mjeseca) i šestero djece (u dobi od 4,6 do 14,2
English: If you see unusual movements in your child, tell your child's doctor who may change the treatment.
Croatian: Ako primijetite pojavu neuobičajenih pokreta u djeteta, obavijestite njegova liječnika, koji će možda promijeniti liječenje.
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.
Croatian: Većina bolesnika u kojih su perimetrijom utvrđena oštećenja vidnog polja nije prethodno spontano primijetila nikakve simptome, čak ni u slučajevima kada je perimetrijom ustanovljeno teško oštećenje.
English: The solution should be administered immediately after preparation.
Croatian: Otopina se mora primijeniti odmah nakon pripreme.
English: You must speak to your child's doctor if your child's condition does not improve within a month of starting vigabatrin.
Croatian: Morate se savjetovati s liječnikom svojeg djeteta ako se unutar mjesec dana od početka liječenja vigabatrinom djetetovo stanje ne poboljša.
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.
Croatian: S obzirom na činjenicu da je u kliničkim ispitivanjima vigabatrina zabilježena omamljenost, bolesnike treba na početku liječenja upozoriti na tu mogućnost.
English: The degree of visual field constriction may be severe and this may have practical consequences for the patient.
Croatian: Suženje vidnog polja može biti teškog stupnja, s mogućim praktičnim posljedicama za bolesnika.
English: If this happens, contact your child's doctor immediately.
Croatian: Ako se to dogodi, odmah se obratite liječniku svojeg djeteta.
English: Special care should be taken with young patients cycling, climbing or performing any other hazardous activity.
Croatian: Posebnu pozornost treba obratiti na mlade bolesnike koji voze bicikl, bave se penjanjem ili bilo kojom drugom opasnom aktivnošću.