FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: ili, u kombinaciji s drugim lijekovima protiv epilepsije, za liječenje parcijalne epilepsije koja se ne može zadovoljavajuće kontrolirati trenutačnim liječenjem.
English: This medicine has been prescribed for your child. Do not pass it on to others.
Croatian: - Ovaj je lijek propisan Vašem djetetu.
English: Pack size: 100 soluble tablets.
Croatian: Veličina pakiranja: 100 tableta za oralnu otopinu.
English: This medicinal product is not intended for use in women who are breastfeeding.
Croatian: Ovaj lijek nije namijenjen za primjenu u žena reproduktivne dobi.
English: In resistant partial epilepsy (focal onset seizures), the recommended starting dose is 40 milligrams per kilogram daily.
Croatian: Farmakorezistentna parcijalna epilepsija (fokalni napadaji) Preporučena početna doza iznosi 40 mg/kg/dan.
English: Rare reports of encephalopathic symptoms such as marked sedation, stupor and confusion in association with non-specific slow wave activity on electroencephalogram have been described soon after the initiation of vigabatrin treatment.
Croatian: kao što su izražena sedacija, stupor i konfuzija povezane s nespecifičnom aktivnošću sporih valova na elektroencefalogramu.
English: Pack size: 50 soluble tablets.
Croatian: Veličina pakiranja: 50 tableta za oralnu otopinu.
English: Visual field loss (loss of sight from the edges of your child's field of vision) may occur during treatment with vigabatrin.
Croatian: Tijekom liječenja vigabatrinom može doći do ispada vidnog polja (gubitak vida u rubnim dijelovima vidnog polja Vašeg djeteta).
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).
Croatian: „infantilni spazmi”, kao ni u djece starije od sedam godina i adolescenata za indikaciju „farmakorezistentna parcijalna epilepsija” (fokalni napadaji).
English: Body weight (kg)
Croatian: Tjelesna težina:
English: Starting dose of 40 mg/kg/day
Croatian: 40 mg/kg/dan
English: Psychiatric events (e.g., agitation, depression, abnormal thinking, paranoid reactions) have been reported during vigabatrin treatment.
Croatian: Tijekom liječenja vigabatrinom zabilježeni su psihijatrijski događaji (npr. agitacija, abnormalno razmišljanje, paranoidne reakcije).
English: Number of tablets (strength) Morning
Croatian: Broj tableta (jačina)
English: Available evidence suggests that the VFD is irreversible even after discontinuation of vigabatrin.
Croatian: Dostupni dokazi upućuju na to da su ispadi vidnog polja ireverzibilni čak i nakon prekida primjene vigabatrina.
English: 0.5 to 1 g/day
Croatian: od 10 do 15 kg: 0,5 do 1 g/dan od 15 do 30 kg: 1 do 1,5 g/dan
English: Psychiatric reactions have been reported during vigabatrin therapy.
Croatian: Opis odabranih nuspojava Tijekom liječenja vigabatrinom zabilježene su psihijatrijske reakcije.
English: Vigabatrin overdose has been reported.
Croatian: Zabilježeno je predoziranje vigabatrinom.
English: Pooled data from prevalence surveys suggest that as many as 1/3 of patients receiving vigabatrin therapy have VFDs.
Croatian: Objedinjeni podaci iz istraživanja prevalencije upućuju na to da ispad vidnog polja nastupa u do 1/3 bolesnika koji se liječe vigabatrinom.
English: Kigabeq 100 mg is supplied in packs of 100 soluble tablets.
Croatian: Kigabeq 100 mg dolazi u pakiranjima od 100 tableta za oralnu otopinu.
English: 500 mg tablet size: 16.0 mm x 9.0 mm
Croatian: veličina tablete od 500 mg: 16,0 mm x 9,0 mm veličina tablete od 100 mg: 9,4 mm x 5,3 mm
English: One tablet (500 mg) and two tablets (100 mg)
Croatian: Jedna tableta (500 mg) i dvije tablete (100 mg)
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije u lijeka promet
English: Some patients may experience an increase in seizure frequency, including status epilepticus with vigabatrin.
Croatian: Pri primjeni vigabatrina u nekih bolesnika može doći od povećane učestalosti napadaja, uključujući epileptični status.
English: Since vigabatrin is eliminated via the kidneys, caution should be exercised in patients with a creatinine clearance of less than 60 ml/min.
Croatian: Oštećenje funkcije bubrega Budući da se vigabatrin uklanja putem bubrega, potreban je oprez u bolesnika s klirensom kreatinina manjim od 60 ml/min.
English: In the brain, microvacuolation due to intramyelinic oedema has been observed in white matter tracts of rat, mouse and dog at doses of 30-50 mg/kg/day.
Croatian: Pri primjeni doza od 30 do 50 mg/kg/dan u mozgu je uočena mikrovakuolacija uzrokovana intramijelinskim edemom trakta bijele tvari u štakora, miševa i pasa.
English: Visual disorders, which can affect the ability to cycle, climb or take part in hazardous activity, have occurred in some patients taking this medicine.
Croatian: U nekih bolesnika koji su uzimali ovaj lijek nastupili su poremećaji vida koji mogu utjecati na sposobnost vožnje bicikla, penjanja ili sudjelovanja u opasnim aktivnostima.
English: Kigabeq 500 mg is supplied in packs of 50 soluble tablets
Croatian: Kigabeq 500 mg dolazi u pakiranjima od 50 tableta za oralnu otopinu.
English: One tablet (500 mg) and one tablet (100 mg)
Croatian: Jedna tableta (500 mg) i jedna tableta (100 mg)
English: Some patients may experience an increase in seizure frequency or the onset of new types of seizures with vigabatrin (see section 4.8).
Croatian: Primjena vigabatrina može u nekih bolesnika dovesti do povećane učestalosti napadaja ili do novih vrsta napadaja (vidjeti dio 4.8).
English: INFORMATION IN BRAILLE Kigabeq 500 mg
Croatian: Kigabeq 500 mg
English: Each soluble tablet contains 500 mg vigabatrin.
Croatian: Jedna tableta za oralnu otopinu sadrži 500 mg vigabatrina.
English: What Kigabeq looks like and contents of the pack Kigabeq are white oval scored soluble tablets.
Croatian: Kigabeq ima oblik bijelih ovalnih tableta za oralnu otopinu s urezom.
English: However, in rabbits, a slight increase in the incidence of cleft palate at doses of 150-200 mg/kg was seen.
Croatian: Međutim, pri primjeni doza od 150 do 200 mg/kg uočeno je blago povećanje incidencije rascjepa nepca u zečeva.
English: Each soluble tablet contains 100 mg vigabatrin.
Croatian: Jedna tableta za oralnu otopinu sadrži 100 mg vigabatrina.
English: Common side effects (may affect up to 1 in 10 people) headache weight gain shaking (tremor ) swelling (oedema) dizziness sensation of numbness or tingling (pins and needles) reduced concentration and memory psychological problems including agitation, aggression, nervousness, irritability, depression, thought disturbance and feeling suspicious without reason (paranoia).
Croatian: glavobolja porast težine drhtanje (tremor) oticanje (edem) omaglica osjećaj utrnulosti ili trnaca smanjena koncentracija i pamćenje psihološki problemi uključujući uznemirenost, agresiju, nervozu, razdražljivost, depresiju,
English: Kigabeq 100 mg soluble tablets Kigabeq 500 mg soluble tablets
Croatian: Kigabeq 100 mg tablete za oralnu otopinu Kigabeq 500 mg tablete za oralnu otopinu
English: Most of the patients with perimetry-confirmed defects have been asymptomatic.
Croatian: Bolesnici u kojih su perimetrijom utvrđena oštećenja vidnog polja bili su uglavnom asimptomatski bolesnici.
English: Movement disorders either alone or in association with abnormalities in MRI have been reported in patients treated with vigabatrin for infantile spasms but their frequency is not known.
Croatian: U bolesnika s infantilnim spazmima koji su liječeni vigabatrinom zabilježeni su poremećaji pokreta, sami ili povezani s abnormalnim nalazima magnetske rezonancije, ali njihova učestalost nije poznata.
English: One tablet (500 mg)
Croatian: Jedna tableta (500 mg)
English: 100 mg tablet size: 9.4 mm x 5.3 mm 500 mg tablet size: 16.0 mm x 9.0 mm
Croatian: veličina tablete od 100 mg: 9,4 mm x 5,3 mm veličina tablete od 500 mg: 16,0 mm x 9,0 mm Nakon otapanja u vodi, otopina je bjelkasta i zamućena.
English: Starting dose of 50 mg/kg/day
Croatian: 50 mg/kg/dan
English: Fill a drinking glass with one or two teaspoons of water (approximately 5 or 10 ml), according to the age of the child. Add the prescribed number of Kigabeq tablets or tablet halves to the water.
Croatian: Ulijte u čašu jednu do dvije čajne žličice vode (otprilike 5 ili 10 ml), ovisno o dobi djeteta.
English: What you need to know before your child takes Kigabeq 3.
Croatian: Što morate znati prije nego što Vaše dijete počne uzimati Kigabeq Nemojte davati lijek Kigabeq:
English: One tablet (100 mg)
Croatian: Jedna tableta (100 mg)
English: Half a tablet (500 mg) or two and a half tablets (100 mg)
Croatian: Dvije i pol tablete (100 mg) Pola tablete (500 mg) ili dvije i pol tablete (100 mg) Pola tablete (500 mg) ili dvije i pol tablete (100 mg) Dvije i pol tablete (100 mg)
English: Pregnancy and breast-feeding This medicine is not intended for use in women of child-bearing potential or in breast-feeding women.
Croatian: Ovaj lijek nije namijenjen za primjenu u žena u reproduktivnoj dobi ni u dojilja.
English: Movement disorders including dystonia, dyskinesia and hypertonia, have been reported in patients treated with vigabatrin for infantile spasms.
Croatian: U bolesnika s infantilnim spazmima koji su liječeni vigabatrinom zabilježeni su poremećaji pokreta, uključujući distoniju, diskineziju i hipertoniju.
English: Group III
Croatian: PRILOG III.
English: • Pour one or two teaspoonfuls (about 5 to 10 ml) of water into a drinking glass or beaker
Croatian: • Ulijte u običnu ili graduiranu čašu jednu do dvije čajne žličice vode za piće (otprilike 5 ili 10 ml).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING 1 BOTTLE OF 100 SOLUBLE TABLETS OF KIGABEQ 100 MG
Croatian: PODATCI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA SADRŽI 1 BOCU OD 100 TABLETA ZA ORALNU OTOPINU KIGABEQ 100 MG
English: Crospovidone type B Mannitol
Croatian: - Drugi sastojci su: krospovidon (vrsta B), manitol, natrijev stearilfumarat
English: Three tablets (100 mg)
Croatian: Tri tablete (100 mg)
English: Syste m organ class
Croatian: PRILOG I. SAŽETAK OPISA SVOJSTAVA LIJEKA
English: De uts chland
Croatian: Oralni klirens
English: Half a tablet (100 mg)
Croatian: Pola tablete (100 mg)
English: Half a tablet (500 mg)
Croatian: Pola tablete (500 mg)
English: Two tablets (100 mg)
Croatian: Dvije tablete (100 mg)
English: If at any time your child has had these symptoms, immediately contact child's doctor.
Croatian: Smjesta se obratite liječniku ako Vaše dijete u bilo kojem trenutku ima te simptome.
English: PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING LABEL FOR BOTTLE CONTAINING 50 SOLUBLE TABLETS OF KIGABEQ 500 MG
Croatian: PODATCI KOJE MORA SADRŽAVATI UNUTARNJE PAKIRANJE NALJEPNICA NA BOCI KOJA SADRŽI 50 TABLETA ZA ORALNU OTOPINU LIJEKA KIGABEQ 500 MG
English: Four tablets (100 mg)
Croatian: Četiri tablete (100 mg)
English: One and a half tablets (500 mg)
Croatian: Jedna i pol tableta (500 mg)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL FOR BOTTLE CONTAINING 100 SOLUBLE TABLETS OF KIGABEQ 100 MG
Croatian: PODATCI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA NA BOCI KOJA SADRŽI 100 TABLETA ZA ORALNU OTOPINU KIGABEQ 100 MG
English: Resistant partial epilepsy (focal onset seizures)
Croatian: godine) s refraktornom epilepsijom.
English: Nervous system disorders somnolenc e speech disorder, headache, dizziness, paraesthesia, disturbance in attention and memory impairment, mental impairment (thought disturbance), tremor coordination abnormal (ataxia)
Croatian: Poremećaji živčanog sustava somnolenci ja poremećaj govora, glavobolja, omaglica, parestezija,
English: Gastrointesti nal disorders nausea, vomiting, abdominal pain
Croatian: Poremećaji probavnog sustava mučnina, povraćanje,
English: HDPE bottle closed with a child resistant tamper evident PP screw cap.
Croatian: Boca od polietilena visoke gustoće (HDPE) s polipropilenskim (PP) zatvaračem na navoj sigurnim za djecu i s evidencijom otvaranja.
English: Kigabeq 500 mg soluble tablets
Croatian: Kigabeq 500 mg tablete za oralnu otopinu
English: Suomi/Finland ORPHELIA Pharma SAS Puh/Tel: + 33 1 42 77 08 18
Croatian: ORPHELIA Pharma SAS Puh/Tel: + 33 1 42 77 08 18
English: Three and a half tablets (100 mg)
Croatian: Tri i pol tablete (100 mg)
English: Four and a half tablets (100 mg)
Croatian: Četiri i pol tablete (100 mg)
English: If your child gets any side effects, talk to your child's doctor or pharmacist.
Croatian: Ako u svojeg djeteta primijetite bilo koju nuspojavu, potrebno je obavijestiti njegova liječnika ili ljekarnika.
English: Eye disorders visual field defect vision blurred, diplopia, nystagmus retinal disorder (such as peripheral retinal atrophy)
Croatian: diplopija, nistagmus poremeća j mrežnice (primjeric e atrofija periferne mrežnice)
English: M anufacture r
Croatian: RMP-a.
English: Hepatic impairment
Croatian: problemi s jetrom
English: One and a half tablets (100 mg)
Croatian: Jedna i pol tableta (100 mg)
English: NAME OF THE MEDICINAL PRODUCT Kigabeq 500 mg soluble tablets vigabatrin
Croatian: Kigabeq 500 mg tablete za oralnu otopinu vigabatrin
English: 1 x 500 mg tablet morning 1 x 500 mg and 1 x 100 mg tablet evening
Croatian: 1 x tableta od 500 mg ujutro 1 x tableta od 500 mg i 1 x tableta od 100 mg navečer
English: General disorders and fatigue oedema, irritability administratio n site conditions
Croatian: Opći poremećaji i reakcije na mjestu primjene umor edem, razdražljivost
English: NAME OF THE MEDICINAL PRODUCT Kigabeq 100 mg soluble tablets vigabatrin
Croatian: Uputa o lijeku: Informacije za korisnika Kigabeq 100 mg tablete za oralnu otopinu
English: 1 x 500 mg and 3 x 100 mg tablet morning 1 x 500 mg and 3 x 100 mg tablet evening
Croatian: 1 x tableta od 500 mg i 3 x tableta od 100 mg ujutro 1 x tableta od 500 mg i 3 x tableta od 100 mg navečer
English: A deterioration of VFD after the treatment is discontinued cannot be excluded.
Croatian: Ne može se isključiti pogoršanje ispada vidnog polja nakon prekida liječenja.
English: 1 x 500 mg and 2 x 100 mg tablet morning 1 x 500 mg and 2 x 100 mg tablet evening
Croatian: 1 x tableta od 500 mg i 2 x tableta od 100 mg ujutro 1 x tableta od 500 mg i 2 x tableta od 100 mg navečer
English: Very common side effects (may affect more than 1 in 10 people) excitation or restlessness tiredness and pronounced sleepiness joint pain
Croatian: Vrlo česte nuspojave (mogu se pojaviti u više od 1 na 10 osoba)
English: 1 x 500 mg and 1 x 100 mg tablet morning 1 x 500 mg and 1 x 100 mg tablet evening
Croatian: 1 x tableta od 500 mg i 1 x tableta od 100 mg ujutro 1 x tableta od 500 mg i 1 x tableta od 100 mg navečer
English: One soluble tablet of Kigabeq 100 mg contains 100 mg vigabatrin One soluble tablet of Kigabeq 500 mg contains 500 mg vigabatrin - The other ingredients are: crospovidone type B, mannitol, sodium stearyl fumarate
Croatian: Kigabeq 100 mg tablete za oralnu otopinu Jedna tableta za oralnu otopinu sadrži 100 mg vigabatrina.
English: 1 x 500 mg and 1 x 100 mg tablet morning 1 x 500 mg and 2 x 100 mg tablet evening
Croatian: 1 x tableta od 500 mg i 1 x tableta od 100 mg ujutro 1 x tableta od 500 mg i 2 x tableta od 100 mg navečer
English: INFORMATION IN BRAILLE Kigabeq 100 mg
Croatian: Kigabeq 100 mg
English: Luxe mbourg/Luxemburg ORPHELIA Pharma SAS Tél/Tel: + 33 1 42 77 08 18
Croatian: ORPHELIA Pharma SAS Tél/Tel: + 33 1 42 77 08 18
English: Kigabeq 100 mg soluble tablets
Croatian: Kigabeq 100 mg tablete za oralnu otopinu
English: Description of selected adverse reactions
Croatian: OTPADNIH MATERIJALA KOJI POTJEČU
English: What Kigabeq contains
Croatian: Sadržaj pakiranja i druge informacije Što Kigabeq sadrži
English: 1 Mean toxin neutralising titre obtained after repeated vaccination of a half dose in rabbits.
Croatian: Znači neutralizirani toksični titar dobiven nakon ponovnog cijepljenja s pola doze u kunića.
English: 2 Mean agglutination titre obtained after a single vaccination of a half dose in rabbits
Croatian: 2 Znači aglutinacijski titar dobiven nakon jednog cijepljenja s pola doze u kunića.
English: Committee for Human Medicinal Products.
Croatian: Povjerenstvo za humane lijekove.
English: 09 October 2013
Croatian: 09 listopada 2013.
English: Outcome of a procedure under Article 29 of Directive 2001/83/EC
Croatian: Ishod postupka u skladu s člankom 29. Direktive 2001/83/EZ
English: The European Commission issued a decision on this opinion on 09 October 2013.
Croatian: Europska komisija izdala je odluku o ovom mišljenju 09. listopada 2013.
English: The company wanted the authorisation to be recognised in Belgium, France, Germany, Luxembourg, Malta, Netherlands, Sweden and United Kingdom (the ‘concerned Member States').
Croatian: Tvrtka je željela da odobrenje bude priznato u Belgiji, Francuskoj, Njemačkoj, Luksemburgu, Malti, Nizozemsoj, Švedskoj i Ujedinjenoj Kraljevini („uključena države članice”).
English: What are the conclusions of the CHMP?
Croatian: Koji su zaključci CHMP?
English: Questions & Answers: Positions on specific questions addressed to the pharmacokinetics working party.
Croatian: Pitanja i odgovori: Stajališta o specifičnim pitanjima koja su upućena radnoj skupini za farmakokinetiku.
English: Two medicines are bioequivalent if they produce the same levels of the active substance in the body.
Croatian: Dva su lijeka bioekvivalentna, ako uzrokuju iste razine djelatne tvari u tijelu.
English: However, the Member States were not able to reach an agreement and the Danish medicines regulatory agency referred the matter to the CHMP for arbitration on 21 December 2012.
Croatian: Međutim, države članice nisu bile u stanju postići dogovor i danska Agencija za lijekove proslijedila je predmet 21. prosinca 2012 na arbitražu u CHMP.
English: Sandoz A/S submitted Methylphenidate Sandoz for mutual recognition on the basis of the initial authorisation granted by Denmark on 29 March 2012 and also valid through a decentralised procedure in Cyprus, Finland, Poland, Portugal and Spain, as well as Iceland and Norway.
Croatian: Sandoz A/S predao je dokumentaciju za Methylphenidate Sandoz za postupak međusobnog priznavanja na temelju početnog odobrenja kojeg Danska dala 29. ožujka 2012. godine, a koje također vrijedi i kroz decentralizirani postupak u Cipru, Finskoj, Poljskoj, Portugalu i Španjolskoj, kao i Islandu i Norveškoj.
English: Methylphenidate is a medicine that is used to treat children aged between 6 and 18 years of age who have ADHD (attention deficit/hyperactivity disorder), a condition in which children show a persistent inability to concentrate, hyperactivity and impulsive behaviour.
Croatian: Metilfenidat je lijek koji se koristi za liječenje djece u dobi između 6 i 18 godina koja imaju ADHD (poremećaj deficita pažnje/hiperaktivnost), stanje u kojem djeca pokazuju stalnu nesposobnost usmjeravanja pažnje, hiperaktivnost i impulzivno ponašanje.
English: It is available as a modified-release tablet, which releases some of the active substance immediately (the ‘immediate-release phase') and the rest over several hours.
Croatian: Dostupan je u obliku tableta s modificiranim otpuštanjem koje oslobađaju neke djelatne tvari odmah („faza neposrednog otpuštanja”), a ostatak tijekom nekoliko sati.
English: On 25 July 2013, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Methylphenidate Sandoz.
Croatian: Europska agencija za lijekove dovršila je 25. srpnja 2013. postupak arbitraže nakon neslaganja između država članica Europske unije (EU) u svezi izdavanja odobrenja za lijek Methylphenidate Sandoz.
English: The Committee also noted that the studies were performed by the applicant before the publication of recent updated guidance1 for products of this type.
Croatian: Povjerenstvo je također zabilježilo da je podnositelj zahtjeva proveo ispitivanja prije objave nedavnih ažuriranih smjernica1 za ovaj tip lijekova.
English: Methylphenidate belongs to a group of medicines called ‘psychostimulants' and is thought to work by enhancing the activity of areas of the brain that control attention and concentration.
Croatian: Metilfenidat pripada skupini lijekova zvanih „psihostimulansi” te se smatra da djeluje pojačavanjem aktivnosti područja mozga koja kontroliraju pozornost i koncentraciju.
English: What is Methylphenidate Sandoz?
Croatian: Što je Methylphenidate Sandoz?
English: Methylphenidate Sandoz is a generic medicine based on a ‘reference medicine', Concerta, which is authorised in all the EU Member States.
Croatian: Methylphenidate Sandoz je generički lijek koji se temelji na „referentnom lijeku” Concerta koji je odobren u svim državama članicama EU-a.
English: As the product information states that the tablet can be taken with or without food, a bioequivalence study in fed conditions was required to grant the marketing authorisation.
Croatian: S obzirom da informacije o lijeku navode da se tableta može uzeti s hranom ili bez nje, zatraženo je ispitivanje bioekvivalencije u uvjetima kad su ispitanici smjeli uzimati hranu kako bi se izdalo odobrenje.
English: EMA/444197/2013 rev. 1 EMEA/H/A-29/1359
Croatian: 1 EMEA/H/A-29/1359
English: Requirements for demonstration of bioequivalence for generics of biphasic modified release formulations for oral use.
Croatian: 11. Zahtjevi za dokazivanjem bioekvivalencije za generičke formulacije za oralnu primjenu s dvofaznim modificiranim otpuštanjem.
English: Why was Methylphenidate Sandoz reviewed?
Croatian: Zašto je Methylphenidate Sandoz ispitan?
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the failure to show bioequivalence between Methylphenidate Sandoz and its reference medicine in the immediate-release phase under fed conditions were due to differences between patients in the effects of a high-fat meal on the way medicines are handled by the body, and not to differences between the formulations of the two medicinal products, and that bioequivalence to the reference medicinal product has been shown.
Croatian: Na temelju procjene trenutačno dostupnih podataka i znanstvenih rasprava unutar Povjerenstva, CHMP je zaključio da je neuspjeh u dokazivanju bioekvivalencije između Methylphenidate Sandoza i njegovog referentnog lijeka u fazi neposrednog otpuštanja, u uvjetima kad je ispitanicima bilo dozvoljeno konzumiranje hrane, bio uzrokovan razlikama između bolesnika u učinku punomasnog obroka na način rukovanja lijekovima od strane tijela, a ne razlikama između formulacija između dva lijeka i da je bioekvivalencija s referentnim lijekom dokazana.
English: It has been available since the 1950s as both immediate-release tablets and capsules, which release methylphenidate straight away, and as modified-release tablets that release some or all of the active substance more slowly over several hours.
Croatian: Dostupan je od 1950.-ih godina u obliku tableta s neposrednim otpuštanjem, kapsula koje odmah otpuštaju metilfenidat te u obliku tableta s modificiranim otpuštanjem koje tijekom nekoliko sati polaganije otpuštaju dio ili cijelu djelatnu tvar.
English: The grounds for the referral were objections raised by Germany and the Netherlands who considered that the bioequivalence study carried out under fed conditions did not show that Methylphenidate Sandoz was bioequivalent for the immediate-release phase to its reference product.
Croatian: Razlozi za procjenu bili su protivljenja koja su iznijela Njemačka i Nizozemska koje su smatrale da ispitivanje bioekvivalencije provedeno u uvjetima kad su se ispitanici smjeli hraniti nije pokazalo da je Methylphenidate Sandoz bioekvivalentan svom referentnom lijeku u fazi neposrednog otpuštanja.