FrancophonIA/ELRC3.0 huggingface dataset:
English: Pyrexia, asthenic conditions (including asthenia, fatigue, lethargy, malaise)
Croatian: asteniju, umor, letargiju, malaksalost)
English: Baxalta Innovations GmbH A-1221 Vienna, Austria
Croatian: A-1221 Beč, Austrija
English: VIAL LABEL RECOMBINANT HUMAN HYALURONIDASE (1.25 ML)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI REKOMBINANTNE LJUDSKE HIJALURONIDAZE (1,25 ML)
English: Immunogenicity of recombinant human hyaluronidase
Croatian: Imunogenost rekombinantne ljudske hijalurodinaze
English: VIAL LABEL HUMAN NORMAL IMMUNOGLOBULIN (2.5 G)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI NORMALNOG LJUDSKOG IMUNOGLOBULINA (2,5 G)
English: Although these side effects have so far not been seen with HyQvia, it is possible that someone using HyQvia may get them: Trembling, oral tingling, fast heart beat, allergic reactions, flushing or pallor, coldness of hand or feet, shortness of breath, swelling of face,excessive sweating, muscle stiffness,change in liver function blood tests (alanine aminotransferase increased).
Croatian: Drhtanje, trnci u ustima, ubrzani otkucaji srca, alergijske reakcije, navala crvenila ili bljedilo, hladne ruke ili stopala, nedostatak zraka, oticanje lica, prekomjerno znojenje, ukočenost mišića izmijenjeni rezultati jetrenih proba (povišena vrijednost alanin-aminotransferaza).
English: Rare (≥1/10,000 to
Croatian: Rijetko i <1/1000)
English: Myalgia, musculoskeletal chest pain
Croatian: Poremećaji živčanog sustava glavobolja migrena, omaglica parestezija
English: Infusion site leakage can occur during or after subcutaneous administration of immunoglobulin, including HyQvia.
Croatian: Tijekom ili nakon supkutane primjene imunoglobulina, uključujući lijek HyQvia, može se pojaviti curenje na mjestu primjene infuzije.
English: Certain side effects may occur more frequently if: - you are receiving HyQvia for the first time.
Croatian: - dobivate lijek HyQvia prvi put;
English: Paresthesia
Croatian: Sljedivost
English: In particular, patients naive to human normal immunoglobulin, patients switched from an alternative immunoglobulin product or when there has been a long interval since the previous infusion should be monitored during the first infusion and for the first hour after the first infusion, in order to detect potential adverse signs.
Croatian: To je posebno važno kod bolesnika koji do tada nisu primali normalni ljudski imunoglobulin, bolesnika koji su prešli s drugog imunoglobulinskog pripravka ili onih kod kojih je prošlo dugo razdoblje od prethodne infuzije.
English: Headache
Croatian: Cijepljenje
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: If HyQvia is accidentally administered into a blood vessel patients could develop shock.
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Ako se HyQvia slučajno primijeni u krvnu žilu, kod bolesnika može doći do šoka.
English: Replacement therapy The medicinal product should be administered via the subcutaneous route.
Croatian: Lijek treba primijeniti supkutano.
English: See leaflet for further information.
Croatian: Za dodatne informacije, vidjeti uputu o lijeku.
English: Two types of profiles were seen.
Croatian: Uočene su dvije vrste profila.
English: Grounds for positive opinion
Croatian: Temelji za pozitivno mišljenje
English: • all strengths have the same qualitative composition
Croatian: • sve jačine imaju isti kvalitativni sastav
English: Scientific conclusions and grounds for positive opinion presented by the European Medicines Agency
Croatian: Znanstveni zaključci i osnove za pozitivno mišljenje koje predstavlja Europska agencija za lijekove
English: The Netherlands and Germany considered that the granting of the marketing authorisation constitutes a potential serious risk to public health.
Croatian: Nizozemska i Njemačka izrazile su sumnju da izdavanje odobrenja za stavljanje u promet predstavlja potencijalan ozbiljan rizik za ljudsko zdravlje.
English: Pharmacokinetic data
Croatian: Farmakokinetski podaci
English: Pharmaceutical data
Croatian: Farmaceutski podaci
English: • The Committed considered the notification of the referral triggered by Denmark under Article 29(4) of Directive 2001/83/EC.
Croatian: • Povjerenstvo je razmotrilo napomenu u uputnici koju je poslala Danska pod Člankom 29(4) Direktive 2001/83/EZ.
English: • all strengths are manufactured by the same manufacturer and process
Croatian: • sve jačine proizvodi isti proizvođač i proizvode se istim postupkom
English: Although the immediate-release part of the dosage form also quickly dissolves, this occurs in the middle of the chyme.
Croatian: Iako se dio za neposredno oslobađanje oblika za doziranje također brzo otapa, to se događa usred himusa.
English: According to the Questions & Answers: Positions on specific questions addressed to the pharmacokinetics working party (EMA/618604/2008 Rev. 7.
Croatian: Prema odlomku Pitanja i odgovori: Stavovi o specifičnim pitanjima koja su postavljena radnoj skupini za farmakokinetiku (EMA/618604/2008 Rev.
English: The 90% CI for these measures were within the acceptance interval of 80%-125%.
Croatian: Intervali pouzdanosti (IP) od 90% za ta mjerenja bili su unutar intervala prihvatljivosti od 80% do 125%.
English: • methylphenidate exhibits linear kinetics among all strengths
Croatian: • metilfenidat pokazuje linearnu kinetiku u svim jačinama
English: • The outer drug coat is proportional in composition among all strengths and the ratio between the amount of the semipermeable membrane and the surface area are comparable amongst all strengths for the applied product.
Croatian: • Vanjski sloj lijeka proporcionalan je u sastavu između svih jačina i omjer između količine polupropusne membrane i površine može se uspoređivati između svih jačina primijenjenog lijeka.
English: Regarding the immediate release part of the formulation the waiver criteria for this part is also considered fulfilled as proportional compositions is used for this part of the formulation.
Croatian: S obzirom na dio formulacije za neposredno oslobađanje, kriterij za odustajanje kod ovog dijela također se smatra ispunjenim jer se za ovaj dio formulacije koriste razmjerni sastavi.
English: The repeat-use MRP was closed on day 210, with most of the CMS agreeing with the conclusions of the RMS's assessment report except Germany and the Netherlands which raised a potential serious risk to public health (PSRPH).
Croatian: MRP za ponovljenu uporabu završen je 210. dana i većina dotičnih država članica složila se sa zaključcima izvješća o procjeni referentne države članice, osim Njemačke i Nizozemske koje su postavile pitanje potencijalnih ozbiljnih rizika za ljudsko zdravlje (PSRPH, eng. potential serious risk to public health).
English: Thus, the dissolved drug is trapped by the high-fat meal in the stomach and cannot easily bypass the stomach contents.
Croatian: Tako je otopljeni lijek zarobljen u obroku bogatom mastima u želucu i ne može lako prodrijeti kroz želučani sadržaj.
English: The approach of applying the requirements for a single unit formulation (6.1.1 of the guideline) and perform one study under fed conditions is considered adequate, with the justification for waiving provided above.
Croatian: Pristup s primjenom zahtjeva za formulaciju s jednom jedinicom (točka 6.1.1 smjernice) i provođenje samo jednog ispitivanja u uvjetima uz hranu smatra se odgovarajućim, uz opravdano izostavljanje koje je prethodno navedeno.
English: In comparison to the originator product, the test product contains similar excipients in the same amounts in the outer drug coat.
Croatian: U usporedbi s izvornim lijekom, ispitivani lijek sadrži slične pomoćne tvari u istim količinama u vanjskom sloju lijeka.
English: Therefore, it is expected that similar results would be obtained in studies under fed conditions with the lower strengths as it was obtained in the studies under fasting conditions for these strengths.
Croatian: Stoga se očekuje da bi se slični rezultati dobili u ispitivanjima u uvjetima uz hranu za manje jačine kao što su dobiveni u ispitivanjima uz uvjete natašte za te jačine.
English: The applicant/MAH further provided a re-evaluation of the data from the fed study based on the different types of plasma profiles observed in this study.
Croatian: Podnositelj zahtjeva/MAH nadalje je predao ponovnu procjenu podataka iz ispitivanja uz hranu na temelju različitih tipova profila u plazmi koji su uočeni u ovom ispitivanju.
English: If no significantly different pharmacokinetic profile between fasting and fed state is expected then the cut-off time point should be identical.
Croatian: Ako se ne očekuje značajna razlika u farmakokinetskom profilu između stanja natašte i stanja sitosti, vremenske točke granične vrijednosti trebaju biti identične.
English: This is also due to the fact that the intra-individual variability decreased (19% instead of 110% for AUC, and 12% instead of 67% for Cmax) by taking into account only those subjects who exhibit a distinct peak for the initial phase under high fat fed conditions.
Croatian: To je posljedica i činjenice da se intraindividualna varijabilnost (kod pojedinog ispitanika) smanjila (19% umjesto 110% za PIK i 12% osim 67% za Cmax) uzimajući u obzir samo one ispitanike koji pokazuju izraženi vrh za početnu fazu u uvjetima prehrane bogate mastima.
English: The second profile was a continuous profile without an early maximum, whereby methylphenidate concentrations slowly increase after an erratic lag time.
Croatian: Drugi profil je bio kontinuirani profil bez ranog maksimuma, gdje su se koncentracije metilfenidata sporo povećavale nakon nepravilnog vremena odgode.
English: • The Committee acknowledged that the conventional criteria for bioequivalence were not met for the immediate release phase in the fed study.
Croatian: • Povjerenstvo je potvrdilo da nisu zadovoljeni konvencionalni kriteriji za bioekvivalenciju za fazu neposrednog oslobađanja u ispitivanju uz hranu.
English: The first profile was a biphasic profile (“target profile” of the reference product Concerta) with an early maximum followed by a decrease or an approximated plateau in the plasma concentrations.
Croatian: Prvi profil je bio bifazičan ("ciljni profil" referentnog lijeka Concerta) s ranim maksimumom iza kojeg slijedi smanjenje ili aproksimirani plato koncentracije u plazmi.
English: Regarding the results obtained in the fed study (2009-18-PRT-2), it was shown that when compared to the fasting study several subjects did not have a biphasic profile but a continuous profile without an early maximum, whereby methylphenidate concentrations slowly increase after an erratic lag time.
Croatian: Što se tiče rezultata dobivenih u ispitivanju uz hranu (2009-18-PRT-2), pokazano je da kad se usporedi s ispitivanjem natašte, nekoliko ispitanika nije imalo bifazični profil već kontinuirani profil bez ranog maksimuma, gdje su se koncentracije metilfenidata sporo povećavale nakon nepravilnog vremena odgode.
English: Lee et al. 2003 investigated the pharmacokinetics of Ritalin LA 40 mg capsule (Methylphenidate hydrochloride also consisting of an IR and ER component) under fasted conditions and after administration of a high fat breakfast.
Croatian: Lee i sur. 2003. ispitivali su farmakokinetiku Ritalina LA, kapsule od 40 mg (metilfenidat hidroklorid koji se također sastoji od NO i PO sastavnice) u uvjetima natašte i nakon primjene doručka bogatog mastima.
English: The applicant/MAH claimed that this is primarily attributed to the high intra-subject variability (66.5% for Cmax(0-2h), 110.1% for AUC (0-2h)) observed in this early phase as the point estimators Cmax(0-2h) and AUC (0-2h) are very close to 100% indicating that with an adequate sample size bioequivalence could have been shown also for these two parameters.
Croatian: Podnositelj zahtjeva/MAH tvrdio je kako se to primarno pripisuje visokoj varijabilnosti između ispitanika (66,5% za Cmax(0-2h), 110,1% za PIK (0-2h)) koja je uočena u ranoj fazi s obzirom na to da su ključni parametri procjene Cmax(0-2h), i PIK (0-2h)) vrlo blizu 100% što znači da bi se bioekvivalencija mogla prikazati i za ta dva parametra uz odgovarajuću veličinu uzorka.
English: The outer layer of the formulation is dissolved and the highly soluble methylphenidate is released immediately.
Croatian: Vanjski sloj formulacije otapa se i visoko topljiv metilfenidat odmah se oslobađa.
English: Overall summary of the scientific evaluation of Methylphenidate Sandoz and associated names (see Annex I)
Croatian: Cjelokupni sažetak znanstvene procjene lijeka Methylphenidate Sandoz i povezanih imena (vidjeti Dodatak I)
English: The major concern raised by Germany and the Netherlands could not be solved during the CMD(h) referral, and the issue was therefore referred to the CHMP.
Croatian: Glavno pitanje koje su postavile Njemačka i Nizozemska nije se moglo riješiti upućivanjem u CMD(h), stoga je predmet proslijeđen Povjerenstvu za lijekove za primjenu kod ljudi (CHMP, eng.
English: The waiver of studies under fed conditions for the lower strengths are considered justified for the following reasons:
Croatian: Odustajanje od ispitivanja uz hranu za manje jačine smatra se opravdanim iz razloga navedenih u nastavku:
English: However, the Committee is of the opinion that the observed deviation is attributed to variability between subjects and to physiological conditions after intake of a high fat meal and this does not translate into differences in quality between Methylphenidate Sandoz and the reference formulations.
Croatian: Međutim, Povjerenstvo smatra da se uočeno odstupanje pripisuje varijabilnosti između ispitanika i fiziološkim uvjetima nakon unosa obroka s mnogo masti i to ne odražava razlike u kvaliteti formulacija lijeka Methylphenidate Sandoz i referentnog lijeka.
English: Based on the discussion above, it is considered reasonable to look at the immediate release phase separately, and fasting conditions is considered more sensitive in relation to detect difference between test and reference for a highly soluble immediate release formulation in order to provide proof of bioequivalence.
Croatian: Na temelju prethodno navedene rasprave, smatra se kako je razumno zasebno promatrati fazu s neposrednim oslobađanjem te da su uvjeti natašte osjetljiviji u pogledu pronalaženja razlika između ispitivanog i referentnog lijeka za lako topljivu formulaciju s neposrednim oslobađanjem kako bi se dokazala bioekvivalencija.
English: Based on the discussion above, the CHMP accepted the arguments provided by the applicant/MAH and agreed that the waiver of the studies under fed conditions for the lower strengths (18 mg and 36 mg) is justified.
Croatian: Na temelju gornje rasprave, CHMP je prihvatio dokaze koje je predao podnositelj zahtjeva/MAH i složio se s time da je odustajanje od ispitivanja uz uvjete s hranom za manje jačine (18 mg i 36 mg) opravdano.
English: • The Committee is of the opinion that bioequivalence was demonstrated under fasting conditions for the immediate and prolonged release phase and under fed conditions for the prolonged release phase.
Croatian: • Povjerenstvo smatra da je bioekvivalencija pokazana u uvjetima natašte za fazu neposrednog i produljenog oslobađanja i u uvjetima uz hranu za fazu produljenog oslobađanja.
English: the CHMP has recommended the granting of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Methylphenidate Sandoz and associated names (see Annex I).
Croatian: CHMP je preporučio izdavanje odobrenja za stavljanje u promet za koje sažetak opisa svojstava lijeka, označavanje i uputa o lijeku ostaju u skladu sa završnim inačicama donesenim tijekom postupka koordinacijske skupine kako je navedeno u Dodatku III za lijek Methylphenidate Sandoz i povezana imena (vidjeti Dodatak I).
English: In addition, the draft guideline on pharmacokinetic and clinical evaluation of modified release dosage forms (EMA/CPMP/EWP/280/96 Corr1) states that the regulatory criteria applied for biphasic modified release products should follow the criteria applied for the prolonged release phase with additional pharmacokinetic parameters (partial AUC and Cmax).
Croatian: Nadalje, nacrt smjernica za farmakokinetsku i kliničku procjenu oblika za doziranje s prilagođenim oslobađanjem (EMA/CPMP/EWP/280/96 Corr1) navodi da zakonodavni kriteriji primjenjivi za lijekove s bifazičnim prilagođenim oslobađanjem moraju biti u skladu s kriterijima koji se primjenjuju za fazu s produljenim oslobađanjem s dodatnim farmakokinetskim parametrima (parcijalni PIK i Cmax).
English: These ratios are considered as key element responsible for the controlled release of the drug from the tablet core.
Croatian: Ti se omjeri smatraju ključnom sastavnicom koja je odgovorna za kontrolirano oslobađanje lijeka iz jezgre tablete.
English: Moreover, it appears that the prolonged release part of the formulation is not significantly affected by food, which is confirmed by the similar results obtained in the studies with the 54 mg strength in fasting and fed conditions, respectively, for both the test and reference product.
Croatian: Štoviše, čini se da hrana ne utječe značajno na dio formulacije za produljeno oslobađanje, što su potvrdili slični rezultati dobiveni u ispitivanjima s jačinom od 54 mg u uvjetima uz hranu i natašte, navedenim redom, za ispitivani i referentni lijek.
English: • For the second phase, the assessment of equivalence should be based on the AUC from the cut-off time until the end of observation period, and on Cmax during the second phase.
Croatian: • Za drugu fazu, procjena ekvivalencije mora se temeljiti na PIK-u od vremenske točke granične vrijednosti do kraja promatranja i na temelju Cmax tijekom druge faze.
English: The CHMP is of the opinion that the applicant/MAH provided sufficient evidence to prove that the variability seen in the fed study (0-2 hours) is not related to differences between the test and reference product, but is related to a food-induced effect, which delays the absorption of the active substance from the immediate release layer.
Croatian: CHMP je iznio mišljenje da je podnositelj zahtjeva/MAH predao dovoljno dokaza u prilog tvrdnji da varijabilnost uočena u ispitivanju uz hranu (0-2 sata) nije povezana s razlikama između ispitivanog i referentnog lijeka, već se veže uz učinak hrane koja odgađa apsorpciju djelatne tvari iz sloja za neposredno oslobađanje.
English: • The Committee is of the opinion that the waiver of the studies under fed conditions for the lower strengths (18 mg and 36 mg) is justified.
Croatian: • Povjerenstvo smatra da je odustajanje od ispitivanja uz uvjete s hranom za manje jačine (18 mg i 36 mg) opravdano.
English: The in vitro dissolution results also confirm that there is no food effect, since the dissolution is not affected by different pH within the physiological range or by applying FeSSGF or FeSSIF dissolution media for any of the strengths.
Croatian: Rezultati otapanja in vitro također potvrđuju da hrana nema utjecaj jer na otapanje ne utječe različita pH vrijednost unutar fiziološkog raspona, kao ni primjena FeSSGF ili FeSSIF medija za otapanje pri svim jačinama.
English: 13 February 2013) for a generic biphasic modified release formulation, equivalence with the reference product needs to be shown for both extent and rate of absorption (reflecting AUC and Cmax for conventional bioequivalence criteria), separately for both the immediate release and extended release phases:
Croatian: 7. 13. veljače 2013.) za formulaciju generika s bifaznim prilagođenim oslobađanjem, mora se prikazati ekvivalencija s referentnim lijekom za oba razmjera i brzine apsorpcije (odražavajući PIK i Cmax za konvencionalne kriterije bioekvivalencije), odvojeno za fazu neposrednog oslobađanja i fazu produljenog oslobađanja:
English: The fed study conducted with the highest strength 54mg was extrapolated to the lower strengths (18 and 36 mg).
Croatian: Ispitivanje uz hranu provedeno za najveću jačinu od 54 mg ekstrapolirano je na manje jačine (18 i 36 mg).
English: The use of partial metrics under fed condition was considered necessary as the reference product can also be taken with food.
Croatian: Smatra se kako je potrebno koristiti podatke parcijalnih mjerenja u uvjetima uz hranu jer se i referentni lijek može uzimati uz obrok.
English: They observed that initial methylphenidate profiles were more variable between the subjects in the fed state than in the fasted state.
Croatian: Uočili su da početni profili metilfenidata više variraju među ispitanicima u stanju nakon obroka, nego u stanju natašte.
English: The PK parameters for the fed study for the immediate release phase were the following: Cmax(0-2h) = 74.8 -142.7 and AUC (0-2h) = 60.0 - 155.6 (90% CI).
Croatian: FK parametri za ispitivanja uz hranu za fazu neposrednog oslobađanja bili su kako je navedeno u nastavku: Cmax(0-2h) = 74,8 - 142,7 i PIK (0-2h) = 60,0 - 155,6 (90% IP).
English: To support the claim that the high variability seen in the fed study is attributed to physiological conditions after intake of a high fat meal and not differences between the test and reference formulations, a discussion on literature data and the results obtained in the fed study is provided.
Croatian: Kako bi se poduprla tvrdnja da se visoka varijabilnost uočena u ispitivanju uz hranu može pripisati fiziološkim uvjetima nakon unosa obroka bogatog mastima, a ne razlikama između ispitivane i referentne formulacije, podnesena je rasprava o podacima iz literature i rezultatima ispitivanja uz hranu.
English: However, the pharmacokinetics (PK) parameters for the immediate release phase (Cmax(0-2h), AUC (0-2h)) for the fed study were not within the conventional criteria of 80%-125%.
Croatian: Međutim, farmakokinetski (FK) parametri za fazu neposrednog oslobađanja (Cmax(0-2h), PIK (0-2h)) u ispitivanju uz hranu nisu bili unutar konvencionalnih kriterija od 80% do 125%.
English: Methylphenidate Sandoz's formulation is designed with an outer coating containing the immediaterelease part surrounding the prolonged-release core (osmotic controlled).
Croatian: Formulacija lijeka Methylphenidate Sandoz dizajnirana je s vanjskim slojem koji sadrži dio za neposredno oslobađanje i okružuje jezgru za produljeno oslobađanje (osmotski kontrolirano).
English: The applicant/MAH claimed that the administration of a biphasic methylphenidate modified release formulation with a high fat meal has a major impact on the gastric emptying and transit time, and therefore, can lead to different shapes in the pharmacokinetic profiles in the early absorption phase.
Croatian: Podnositelj zahtjeva/MAH tvrdio je da primjena formulacije bifazičnog metilfenidata s prilagođenim oslobađanjem uz obrok bogat mastima ima značajan utjecaj na pražnjenje želuca i vrijeme prolaska te stoga može dovesti do različitih oblika farmakokinetskih profila u ranoj fazi apsorpcije.
English: Because the pharmacokinetic studies were performed in 20092010 the Q&A Position Paper was not taken into consideration by the applicant/MAH.
Croatian: Budući da su farmakokinetska ispitivanja provedena u 2009.-2010., podnositelj zahtjeva/MAH nije razmotrio Članak s pitanjima i odgovorima koji je zasnovan na stavovima.
English: Therefore bioequivalence under fed conditions for the two phases of absorption (IR and PR) should be demonstrated.
Croatian: Stoga se mora prikazati bioekvivalencija u uvjetima uz hranu za obje faze apsorpcije (NO i PO).
English: The application for Methylphenidate Sandoz is therefore based on bioequivalence studies between the applied and the reference product.
Croatian: Stoga se primjena lijeka Methylphenidate Sandoz temelji na ispitivanjima bioekvivalencije primijenjenog i referentnog lijeka.