FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Prije nego što Vaše dijete započne s liječenjem, trebate razgovarati o toj mogućnosti s liječnikom, koji će Vam reći kako možete prepoznati ovu nuspojavu.
English: Skin and subcutaneou s tissue disorders rash angioede ma, urticaria
Croatian: Poremećaji kože i potkožnog tkiva osip angioede m, urtikarija
English: If you have any further questions, ask your child's doctor or pharmacist.
Croatian: - Ako imate dodatnih pitanja, obratite se liječniku svojeg djeteta ili ljekarniku.
English: If a patient is to be withdrawn from vigabatrin treatment, it is recommended that this is done by gradual dose reduction over a 2- to 4-week period.
Croatian: Ako treba prekinuti liječenje bolesnika vigabatrinom, preporučuje se postupno smanjenje doze tijekom razdoblja od dva do četiri tjedna.
English: Not known (frequency cannot be estimated from the available data) movement disorders and abnormalities in magnetic resonance imaging (MRI) brain scans in young infants treated for infantile spasms
Croatian: Nepoznato (učestalost se ne može procijeniti na temelju dostupnih podataka) poremećaji kretnji i abnormalni nalazi magnetske rezonancije mozga u male dojenčadi liječene zbog infantilnih spazama
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.
Croatian: Na temelju dostupnih podataka, izgleda da su prvi oscilatorni potencijal i odgovori na titraje od 30 Hz na retinogramu povezani s ispadom vidnog polja zbog primjene vigabatrina.
English: encephalo pathy optic neuritis brain MRI abnormalities.
Croatian: encefalop atija optički neuritis abnormalni nalazi MR-a mozga,
English: The tube should be rinsed with 10 ml of water
Croatian: Želučanu sondu treba isprati s 10 ml vode.
English: Therefore, vigabatrin should only be used after careful benefit/ risk assessment compared with alternatives.
Croatian: Stoga vigabatrin treba primjenjivati samo nakon pažljive procjene omjera koristi i rizika u usporedbi s drugim terapijama.
English: Decreases in ALT and AST, which are considered to be a result of inhibition of these aminotransferases by vigabatrin, have been observed.
Croatian: Zabilježena su smanjenja ALT-a i AST-a, za koja se smatra da su posljedica inhibicijskog djelovanja vigabatrina na te aminotransferaze.
English: Patients should be monitored for adverse reactions such as sedation or confusion (see sections 4.4 and 4.8).
Croatian: Potreban je nadzor bolesnika zbog pojave nuspojava kao što su sedacija ili smetenost (vidjeti dijelove 4.4 i 4.8).
English: • The mixture will be whitish and cloudy.
Croatian: • Smjesa će biti bjelkasta i zamućena.
English: Activated charcoal has been shown to not significantly adsorb vigabatrin in an in vitro study.
Croatian: Aktivni ugljen nije značajno adsorbirao vigabatrin u in vitro ispitivanju.
English: White oval tablets.
Croatian: Tableta za oralnu otopinu Bijele ovalne tablete.
English: Kigabeq 500 mg soluble tablets EU/1/18/1302/002
Croatian: Kigabeq 500 mg tablete za oralnu otopinu EU/1/18/1302/002
English: If you have any further questions on the use of this medicine, ask the doctor or pharmacist.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku ili ljekarniku.
English: The benefit/risk ratio of vigabatrin should be evaluated on an individual patient basis.
Croatian: Omjer koristi i rizika vigabatrina treba procijeniti za svakog pojedinog bolesnika.
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.
Croatian: Ako je Vaše dijete obavilo ili treba obaviti laboratorijske pretrage, obavijestite o tomu njegova liječnika jer ovaj lijek može prouzročiti abnormalne nalaze.
English: If new movement disorders occur during treatment with vigabatrin, consideration should be given to dose reduction or a gradual discontinuation of treatment.
Croatian: Ako se tijekom liječenja vigabatrinom pojave novi poremećaji kretanja, trebalo bi razmotriti smanjenje doze ili postupno prekidanje liječenja.
English: ORPHELIA Pharma SAS 85 boulevard Saint-Michel 75005 PARIS France
Croatian: Pharma SAS 85 boulevard Saint-Michel 75005 PARIZ
English: The plasma concentrations of carbamazepine, phenobarbital, and sodium valproate have also been monitored during controlled clinical trials and no clinically significant interactions have been detected.
Croatian: Tijekom kontroliranih kliničkih ispitivanja promatrane su plazmatske koncentracije karbamazepina, fenobarbitala i natrijevog valproata, no nisu utvrđene klinički značajne interakcije.
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
Croatian: • Isperite čašu ili graduiranu čašu s jednom do dvije čajne žličice vode (otprilike 5 ili 10 ml) i dajte to djetetu kako biste bili sigurni da je dobilo sav lijek.
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.
Croatian: Roditeljima i/ili njegovateljima moraju se detaljno opisati učestalost i posljedice razvoja ispada vidnog polja tijekom liječenja vigabatrinom.
English: This visual field defect can range from mild to severe.
Croatian: Ovaj ispad vidnog polja može biti blagog do teškog stupnja.
English: Kigabeq 100 mg soluble tablets EU/1/18/1302/001
Croatian: Kigabeq 100 mg tablete za oralnu otopinu EU/1/18/1302/001
English: Adolescents and adults (>12 years old)
Croatian: Adolescenti i odrasle osobe (>12 godina) Skupina I.1 Skupina II.2 Skupina III.
English: Visual field testing should continue at 6 month intervals for the whole duration of treatment.
Croatian: Ispitivanja vidnog polja treba tijekom trajanja liječenja nastaviti u razmacima od šest mjeseci.
English: Other medicines and Kigabeq
Croatian: Drugi lijekovi i Kigabeq
English: These patients should be monitored closely for undesirable effects such as sedation and confusion (see section 4.2).
Croatian: Takve bolesnike potrebno je pažljivo pratiti zbog moguće pojave nuspojava kao što su sedacija i konfuzija (vidjeti dio 4.2).
English: Kigabeq is indicated in infants and children from 1 month to less than 7 years of age for: Treatment in monotherapy of infantile spasms (West's syndrome).
Croatian: Kigabeq je indiciran za primjenu u dojenčadi i djece u dobi od navršenog jednog mjeseca do manje od sedam godina za: monoterapiju kod infantilnih spazama (Westov sindrom).
English: Childre n Do not give this medicine to children less than 1 month of age or more than 7 years of age.
Croatian: Nemojte davati ovaj lijek djeci mlađoj od jednog mjeseca ili starijoj od sedam godina.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU
English: In both rat and dog they were reversible on stopping vigabatrin treatment and even regressed with continued treatment.
Croatian: U štakora i pasa lezije su bile reverzibilne nakon prekida liječenja vigabatrinom te su se čak povukle pri nastavku liječenja.
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.
Croatian: Nuspojave koje su se tijekom liječenja vigabatrinom najčešće prijavljivale su ispadi vidnog polja (u rasponu od blagih do teških, uglavnom nakon više mjeseci ili godina liječenja vigabatrinom), psihijatrijski poremećaji kao što su agitacija, ekscitacija, agresivnost, nervoza, depresija, paranoidne reakcije, poremećaji živčanog sustava kao što su izražena sedacija, stupor i konfuzija.
English: Vigabatrin is a selective irreversible inhibitor of GABA transaminase, the enzyme responsible for the breakdown of GABA (gamma aminobutyric acid).
Croatian: Vigabatrin je selektivni, ireverzibilni inhibitor GABA transaminaze, enzima odgovornog za razgradnju
English: The recommended starting dose is 50 mg/kg/day.
Croatian: Preporučena početna doza iznosi 50 mg/kg/dan.
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.
Croatian: mg/kg/dan svaka tri dana do najviše preporučene doze od 150 mg/kg/dan.
English: Table 1: Number of soluble tablets according to body weight, starting dose and dose increment in infantile spasms Body we ight (kg)
Croatian: Tablica 1.: Broj tableta za oralnu otopinu prema tjelesnoj težini, početnoj dozi i povećanju doze kod infantilnih spazama Tjelesna težina (kg)
English: Kigabeq is for oral or gastric administration twice daily and may be taken before or after meals.
Croatian: Lijek Kigabeq namijenjen je za peroralnu ili gastričnu primjenu dvaput na dan, a može se uzeti prije ili nakon obroka.
English: Available data suggests that visual field defects are irreversible.
Croatian: Dostupni podatci upućuju na to da su ispadi vidnog polja ireverzibilni.
English: Gastric administration
Croatian: Gastrična primjena
English: Other less frequently reported symptoms included vertigo, headache, psychosis, respiratory depression or apnoea, bradycardia, hypotension, agitation, irritability, confusion, abnormal behaviour, and speech disorder.
Croatian: Drugi rjeđe prijavljeni simptomi uključuju vrtoglavicu, glavobolju, psihozu, respiratornu depresiju ili apneju, bradikardiju, hipotenziju, agitaciju, razdražljivost, konfuziju, abnormalno ponašanje i poremećaj govora.
English: How to give Kigabeq
Croatian: Kako davati Kigabeq
English: New onset myoclonus and exacerbation of existing myoclonus may occur in rare cases.
Croatian: U rijetkim slučajevima može doći do novog mioklonusa ili pogoršanja postojećeg.
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.
Croatian: Budući da se vigabatrin uklanja putem bubrega, potreban je oprez pri primjeni lijeka u bolesnika s klirensom kreatinina manjim od 60 ml/min.
English: Monotherapy for infantile spasms (West's Syndrome)
Croatian: Monoterapija kod infantilnih spazama (Westov sindrom)
English: Perimetry is seldom possible in children less than 9 years of developmental age.
Croatian: U djece razvojne dobi ispod devet godina perimetrija je moguća tek u rijetkim slučajevima.
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).
Croatian: - ako je Vaše dijete alergično na vigabatrin ili neki drugi sastojak ovog lijeka (naveden u dijelu
English: If you forget to give your child Kigabeq
Croatian: Ako ste zaboravili dati Kigabeq djetetu
English: Undesirable effects ranked under headings of frequency are listed below, using the following convention:
Croatian: Nuspojave navedene u nastavku razvrstane su prema učestalosti pojavljivanja u skladu sa sljedećim pravilima:
English: The resulting solution is whitish and cloudy.
Croatian: Nastala otopina je bjelkasta i zamućena.
English: movement disorders, including dystonia, dyskinesia and hypertonia, either alone or in association with abnormalities in MRI
Croatian: uključujući distoniju, diskineziju i hipertoniju, sami ili povezani s abnormalnim nalazima MRa mozga
English: Table 2: Number of soluble tablets according to body weight and starting dose in resistant partial epilepsy
Croatian: Tablica 2.: Broj tableta za oralnu otopinu prema tjelesnoj težini i početnoj dozi kod farmakorezistentne parcijalne epilepsije Tjelesna težina (kg)
English: Talk to your child's doctor before you give Kigabeq if your child: has or has had depression or any other psychiatric illness in the past has had any kidney problems as he/she could develop symptoms like sedation or confusion has had any eye problems.
Croatian: Obavijestite liječnika svojeg djeteta prije davanja lijeka Kigabeq ako je Vaše dijete: - u prošlosti bolovalo ili trenutačno boluje od depresije ili bilo koje druge psihijatrijske bolesti
English: If your child has visual disturbances, contact your child's doctor or hospital immediately.
Croatian: Ako Vaše dijete ima poremećaje vida, odmah se obratite njegovu liječniku ili otiđite u bolnicu.
English: Available data suggests that visual field defects are irreversible even after discontinuation of vigabatrin.
Croatian: Dostupni podatci upućuju na to da su ispadi vidnog polja ireverzibilni čak i nakon prekida primjene vigabatrina.
English: Dose (mg per day)
Croatian: Doza (mg na dan)
English: • Give the mixture straightway to your child direct from the drinking glass or beaker
Croatian: • Odmah dajte smjesu djetetu, izravno iz čaše ili graduirane čaše.
English: For patients who cannot swallow, administration of Kigabeq using a gastric tube is possible.
Croatian: U slučaju bolesnika koji ne mogu gutati, primjena lijeka Kigabeq moguća je putem želučane sonde.
English: The clinical significance of these MRI abnormalities is unknown.
Croatian: Nije poznat klinički značaj tih abnormalnih nalaza magnetske rezonancije.
English: Use immediately following preparation of the oral solution.
Croatian: Nakon pripreme oralne otopine smjesta upotrijebite.
English: In the central visual field (within 30 degree of eccentricity), frequently an annular nasal defect is seen.
Croatian: stupnjeva ekscentriciteta) često je prisutan anularni nazalni poremećaj.
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.
Croatian: Budući da se vigabatrin ne metabolizira niti se vezuje na protein i ne inducira jetrene citokrom P450
English: The adverse reactions listed below have been reported during pre- or post-approval use of vigabatrin worldwide.
Croatian: Nuspojave navedene u nastavku prijavljene su tijekom primjene vigabatrina diljem svijeta prije i nakon dobivanja odobrenja za stavljanje lijeka u promet.
English: Such reactions have been fully reversible following dose reduction or discontinuation of vigabatrin (see section 4.4).
Croatian: Takve su reakcije bile u potpunosti reverzibilne nakon smanjenja doze ili prekida primjene vigabatrina (vidjeti dio 4.4).
English: Hepatobiliar y disorders hepatitis
Croatian: Poremećaji jetre i žuči hepatitis
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
Croatian: drugi problemi s očima kao što su bol u očima (optički neuritis) i gubitak vida, uključujući vid za boje (optička atrofija) halucinacije (bolesnici osjećaju, čuju ili vide nešto čega nema)
English: If your child takes too much Kigabeq
Croatian: Ako Vaše dijete uzme prekomjernu dozu lijeka Kigabeq
English: Psychiatric disorders agitation, aggression, nervousness, depression, paranoid reaction hypomania, mania, psychotic disorder suicide attempt hallucination
Croatian: Psihijatrijski poremećaji agitacija, agresivnost, nervoza, depresija, paranoidna reakcija hipomanija, manija,
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).
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) - Promjene vidnog polja - promjene vidnog polja (suženje vidnog polja) moguće su u otprilike 33
English: Asymptomatic and transient Magnetic Resonance Imaging (MRI) abnormalities in the brain have been observed in some infants treated with vigabatrin for infantile spasms.
Croatian: Kod oslikavanja magnetskom rezonancijom zabilježene su asimptomatske i prolazne abnormalnosti mozga u neke dojenčadi liječene vigabatrinom zbog infantilnih spazama.
English: These events occurred in patients with and without a psychiatric history and were usually reversible when vigabatrin doses were reduced or gradually discontinued.
Croatian: Ti događaji nastupili su u bolesnika s anamnezom psihijatrijskih poremećaja i bez nje te su uglavnom bili reverzibilni nakon smanjenja doze vigabatrina ili postupnog ukidanja liječenja.
English: optic atrophy
Croatian: optička atrofija
English: The method of administration will be determined by a physician specialised in epileptology, neurology or paediatric neurology.
Croatian: Način primjene odredit će liječnik specijalist iz područja epileptologije, neurologije ili pedijatrijske neurologije.
English: Musculoskel etal and connective tissue disorders arthralgia
Croatian: Poremećaji mišićnokoštanog sustava i vezivnog tkiva artralgija
English: Kigabeq is to be given by mouth and may be taken before or after meals.
Croatian: Lijek Kigabeq namijenjen je za uzimanje kroz usta, a može se uzeti prije ili nakon obroka.
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).
Croatian: Te su reakcije nastupile u bolesnika s anamnezom psihijatrijskih poremećaja i bez nje, te su uglavnom bile reverzibilne nakon smanjenja doze vigabatrina ili postupnog ukidanja liječenja (vidjeti dio 4.4).
English: These events have been reversible following dose reduction or discontinuation of vigabatrin (see section 4.8).
Croatian: Ti su događaji bili reverzibilni nakon smanjenja doze ili prekida primjene vigabatrina (vidjeti dio 4.8).
English: These side effects usually stop when doses are reduced or the medicine is gradually discontinued.
Croatian: Ove nuspojave uglavnom prestaju nakon smanjenja doza ili postupnog ukidanja liječenja.
English: Patients should undergo systematic screening examination when starting vigabatrin and at regular intervals for detection of visual field defects.
Croatian: Bolesnici prije početka liječenja vigabatrinom trebaju obaviti sistematski probirni pregled te redovito obavljati preglede s ciljem otkrivanja ispada vidnog polja.
English: If you stop giving Kigabeq to your child
Croatian: Ako djetetu prestanete davati Kigabeq
English: Contact the doctor if your child has these psychological effects nausea (feeling sick), vomiting and abdominal pain blurred vision, double vision and uncontrolled movement of the eye, which may cause dizziness speech disorder decrease in the number of red blood cells (anaemia)
Croatian: mučnina, povraćanje i bol u abdomenu zamućen vid, dvoslike i nekontrolirane pokrete oka koji mogu prouzročiti omaglicu poremećaj govora smanjenje broja crvenih krvnih stanica (anemija)
English: Vigabatrin is not significantly metabolised.
Croatian: Ne dolazi do značajne metabolizacije vigabatrina.
English: Vigabatrin may lead to a decrease in measured plasma activity of alanine aminotransferase (ALT) and to a lesser extent, aspartate aminotransferase (AST).
Croatian: Vigabatrin može prouzročiti smanjenje izmjerene aktivnosti alanin aminotransferaze (ALT) u plazmi i,
English: Some patients may have more seizures (fits) whilst taking Kigabeq.
Croatian: Neki bolesnici tijekom liječenja lijekom Kigabeq mogu imati više napadaja.
English: However, the VFDs reported in patients receiving vigabatrin have ranged from mild to severe.
Croatian: Međutim prijavljeni ispadi vidnog polja u bolesnika koji su primali vigabatrin bili su u rasponu od blagih do teških.
English: Follow-up should be arranged under supervision of a specialist in epileptology, neurology or paediatric neurology.
Croatian: Praćenje bolesnika treba provoditi pod nadzorom specijalista iz područja epileptologije, neurologije ili pedijatrijske neurologije.
English: If a visual field constriction is observed during follow-up, consideration should be given to gradual discontinuation of vigabatrin.
Croatian: Ako se tijekom praćenja zamijeti suženje vidnog polja, treba razmotriti postupan prekid liječenja vigabatrinom.
English: The onset is usually after months to years of vigabatrin therapy.
Croatian: Do te pojave obično dolazi nakon više mjeseci ili godina liječenja vigabatrinom.
English: Such changes have not been seen in vigabatrin treated patients without a VFD.
Croatian: Takve promjene nisu zapažene u bolesnika bez ispada vidnog polja koji su liječeni vigabatrinom.
English: The active substance is vigabatrin.
Croatian: - Djelatna tvar je vigabatrin.
English: Kigabeq is for oral or gastric use and may be taken before or after meals.
Croatian: Način primjene Lijek Kigabeq namijenjen je za peroralnu ili gastričnu primjenu, a može se uzeti prije ili nakon obroka.
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).
Croatian: odmah obavijestite njegova liječnika osip ili koprivnjača izražena sedacija (pospanost), stupor i smetenost (encefalopatija).
English: Uncommon side effects (may affect up to 1 in 100 people) lack of coordination or fumbling more severe psychological problems such as feeling elated or over-excited, which causes unusual behaviour, and feeling detached from reality skin rash
Croatian: gubitak koordinacije ili nespretnost pokreta teži psihološki problemi kao što su osjećaj oduševljenja i pretjerane uzbuđenosti koji dovodi do neuobičajenog ponašanja, te osjećaj odvojenosti od stvarnosti osip kože
English: If your child develops symptoms like sleepiness, reduced consciousness and movements (stupor) or confusion, tell your child's doctor who may reduce the dose or stop Kigabeq treatment.
Croatian: (stupor) ili smetenost, obavijestite liječnika svojeg djeteta koji će možda smanjiti dozu lijeka Kigabeq ili prekinuti liječenje.
English: In infantile spasms (West's Syndrome), the recommended starting dose is 50 milligrams per kilogram bodyweight daily.
Croatian: Preporučena početna doza za liječenje infantilnih spazama (Westov sindrom) iznosi 50 miligrama po kilogramu tjelesne težine na dan.
English: Movement disorders can occur in young infants treated for infantile spasms (West's syndrome).
Croatian: U mlade dojenčadi liječene zbog infantilnih spazama (Westov sindrom) može doći do poremećaja pokreta.
English: This is normal and due to presence of water-insoluble excipients.
Croatian: To je uobičajeno zbog pomoćnih tvari koje nisu topljive u vodi.
English: How to store Kigabeq
Croatian: Kako čuvati Kigabeq
English: Abnormal Magnetic Resonance Imaging (MRI) signal changes characterised by increased T2 signal and restricted diffusion in a symmetric pattern involving the thalamus, basal ganglia, brain stem, and cerebellum have been observed in some infants treated with vigabatrin for infantile spasms.
Croatian: U neke dojenčadi liječene vigabatrinom zbog infantilnih spazama zabilježene su abnormalne promjene signala magnetske rezonancije obilježene povećanjem T2 signala i ograničenom difuzijom u simetričnom uzorku koji uključuje talamus, bazalne ganglije, moždano deblo i mali mozak.
English: Abrupt withdrawal may lead to rebound seizures.
Croatian: Nagli prekid liječenja može dovesti do napadaja uslijed ustezanja lijeka (engl. rebound).
English: These side effects usually stop when vigabatrin doses are reduced or the medicine is gradually discontinued.
Croatian: Ove nuspojave uglavnom prestaju nakon smanjenja doza vigabatrina ili postupnog ukidanja liječenja.
English: Vigabatrin treatment may only be initiated by a specialist in epileptology, neurology or paediatric neurology.
Croatian: Liječenje vigabatrinom mora započeti specijalist iz područja epileptologije, neurologije ili pedijatrijske neurologije.
English: Ös te rreich
Croatian: I DOHVATA