FrancophonIA/ELRC3.0 huggingface dataset:
English: 20 ml (10 doses) 100 ml (50 doses) 200 ml (100 doses) 12 x 20 ml (12 x 10 doses) 12 x 100 ml (12 x 50 doses) 12 x 200 ml (12 x 100 doses)
Slovenian: 20 ml (10 odmerkov) 100 ml (50 odmerkov) 200 ml (100 odmerkov) 12 x 20 ml (12 x 10 odmerkov) 12 x 100 ml (12 x 50 odmerkov) 12 x 200 ml (12 x 100 odmerkov)
English: Duration of immunity: 6 months
Slovenian: Trajanje imunosti:
English: For active immunisation of gilts and sows from the age of 5 months to protect progeny against transplacental infection caused by porcine parvovirus.
Slovenian: Za aktivno imunizacijo mladic in svinj, starih več kot 5 mesecev, za zaščito potomcev pred transplacentalno okužbo, ki jo povzroča prašičji parvovirus.
English: Shelf life after first opening the immediate packaging:
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine:
English: Administer a single dose (2 ml) of the mixture intramuscularly.
Slovenian: Enkratni odmerek (2 ml) razredčenega zdravila injicirajte intramuskularno.
English: Adjuvant: Carbomer 2 mg
Slovenian: Karbomer 2 mg
English: 20 ml bottle
Slovenian: 20-ml plastenka
English: Colourless to slightly brown, opalescent suspension for injection.
Slovenian: Brezbarvna do rahlo rjava, opalescentna suspenzija za injiciranje.
English: Sodium chloride Water for injections Potassium chloride Potassium dihydrogen phosphate Disodium phosphate anhydrous
Slovenian: Kalijev dihidrogenfosfat Brezvodni natrijev hidrogenfosfat
English: Pharmacotherapeutic group: Immunologicals for Suidae, inactivated viral vaccines, porcine parvovirus ATCvet code: QI09AA02
Slovenian: Farmakoterapevtska skupina: imunološka zdravila za prašiče (Suidae), inaktivirana virusna cepiva, prašičji parvovirus
English: Shelf life of the veterinary medicinal product as packaged for sale:
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo:
English: PACKAGE SIZE
Slovenian: VELIKOSTI PAKIRANJA
English: Colourless to slightly brown, opalescent suspension.
Slovenian: Brezbarvna do rahlo rjava, opalescentna suspenzija.
English: ReproCyc ParvoFLEX suspension for injection
Slovenian: ReproCyc ParvoFLEX suspenzija za injiciranje
English: ReproCyc ParvoFLEX suspension for injection for pigs
Slovenian: ReproCyc ParvoFLEX suspenzija za injiciranje za prašiče
English: DATE OF AUTHORISATION/RENEWAL OF THE AUTHORISATION
Slovenian: DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO
English: 10 doses
Slovenian: 10 odmerkov
English: Mixing with ReproCyc PRRS EU:
Slovenian: Redčenje z zdravilom ReproCyc PRRS EU:
English: Carton of 20 ml, 100 ml, 200 ml bottles
Slovenian: Škatla z 20-ml, 100-ml, 200-ml plastenkami
English: Name and address of the manufacturers responsible for batch release Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
Slovenian: Ime in naslov proizvajalca zdravila, odgovornega za sproščanje serij Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
English: 100 ml (50 doses) 200 ml (100 doses)
Slovenian: 100 ml (50 odmerkov) 200 ml (100 odmerkov)
English: 100 doses (200 ml)
Slovenian: 100 odmerkov (200 ml)
English: EU/2/19/237/001-006
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/19/237/001-006
English: The package leaflet of ReproCyc PRRS EU should also be consulted before the administration of the mixed product.
Slovenian: Pred uporabo razredčenega zdravila je treba prebrati navodila za uporabo ReproCyc PRRS EU.
English: PACKAGE LEAFLET: ReproCyc ParvoFLEX suspension for injection for pigs
Slovenian: NAVODILO ZA UPORABO: ReproCyc ParvoFLEX suspenzija za injiciranje za prašiče
English: Shelf life after mixing with ReproCyc PRRS EU:
Slovenian: Rok uporabnosti po razredčenju z zdravilom ReproCyc PRRS EU:
English: Porcine Parvovirus strain 27a VP2 subunit antigen: ≥ 1.0 RP* * Relative potency (ELISA).
Slovenian: Podenota antigena VP2 prašičjega parvovirusa seva 27a : ≥ 1,0 RU* * Relativni učinek (ELISA).
English: Porcine Parvovirus strain 27a VP2 subunit antigen ≥ 1.0 RP* * Relative Potency (ELISA)
Slovenian: Podenota antigena VP2 prašičjega parvovirusa seva 27a ≥ 1,0 RU* * Relativni učinek (ELISA)
English: U.S.A.
Slovenian: Rp-Vet.
English: High density polyethylene bottles containing 20 ml (10 doses), 100 ml (50 doses) and 200 ml (100 doses).
Slovenian: Polietilenske plastenke z visoko gostoto, ki vsebujejo 20 ml (10 odmerkov), 100 ml (50 odmerkov) in 200 ml (100 odmerkov).
English: Porcine Parvovirus VP2 subunit antigen: ≥ 1.0 RP* * Relative Potency (ELISA) Carbomer 2 mg.
Slovenian: Podenota antigena VP2 prašičjega parvovirusa: ≥ 1,0 RU* * Relativni učinek (ELISA)
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo: Ni smiselno.
English: 1 bottle of 20 ml (10 doses), 100 ml (50 doses) or 200 ml (100 doses) packed in a cardboard box.
Slovenian: 1 plastenka z 20 ml (10 odmerkov), 100 ml (50 odmerkov) ali 200 ml (100 odmerkov) pakirana v kartonski škatli.
English: 12 bottles of 20 ml (10 doses), 100 ml (50 doses) or 200 ml (100 doses) packed in a cardboard box.
Slovenian: 12 plastenk z 20 ml (10 odmerkov), 100 ml (50 odmerkov) ali 200 ml (100 odmerkov) pakiranih v kartonski škatli.
English: 1 bottle of 20 ml (10 doses), 100 ml (50 doses) or 200 ml (100 doses).
Slovenian: 1 plastenka z 20 ml (10 odmerkov), 100 ml (50 odmerkov) ali 200 ml (100 odmerkov).
English: 12 bottles of 20 ml (10 doses), 100 ml (50 doses) or 200 ml (100 doses).
Slovenian: 12 plastenk z 20 ml (10 odmerkov), 100 ml (50 odmerkov) ali 200 ml (100 odmerkov).
English: 4.6 Adverse reactions (frequency and seriousness)
Slovenian: 4.6 Neželeni učinki (pogostost in resnost) Prehodna rdečina ali oteklina (do 4 cm), ki jo povzroča postopek injiciranja, je zelo pogosta.
English: Name and address of the manufacturer of the biological active substance Boehringer Ingelheim Vetmedica Inc.
Slovenian: Imetnik dovoljenja za promet z zdravilom in proizvajalec odgovoren za sproščanje serij: Boehringer Ingelheim Vetmedica GmbH
English: Very little detailed information is available from the post-marketing setting.
Slovenian: Iz obdobja trženja je na voljo zelo malo podrobnih informacij.
English: • Non-clinical
Slovenian: • Neklinični vidiki
English: The CHMP is of the opinion that pursuant to Article 12 of Regulation (EC) No 726/2004, the safety of the above mentioned medicinal product is not properly or sufficiently demonstrated.
Slovenian: Odbor CHMP je menil, da v skladu s členom 12 Uredbe (ES) št. 726/2004 varnost zgoraj navedenega zdravila ni bila ustrezno ali zadovoljivo dokazana.
English: In addition, there is at least one literature case report of arrhythmia.
Slovenian: Poleg tega obstaja vsaj eno poročilo iz literature o primeru aritmije.
English: However, no correction for multiplicity was performed when evaluating individual doses.
Slovenian: Vendar pri oceni posameznih odmerkov ni bil izveden popravek mnogoterosti.
English: As 4423 patients were exposed to Iloperidone, this accounts for 0.14% of all treated patients.
Slovenian: Ker je bilo iloperidonu izpostavljenih 4 423 bolnikov, to pomeni 0,14 % vseh zdravljenih bolnikov.
English: Overall summary of the scientific evaluation of Fanaptum
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Fanaptum
English: Late onset of action is regarded as a considerable drawback.
Slovenian: Zapoznel začetek delovanja velja za znatno pomanjkljivost.
English: There were 33 deaths of which 3 patients died during sleep, 6 were sudden deaths, and 6 cases were of cardiac origin.
Slovenian: Prišlo je do 33 smrtnih primerov, pri katerih so trije bolniki umrli med spanjem, šest nenadnih smrti in šest primerov kardiološkega izvora.
English: This means that, from a precautionary approach, patients could not safely be concomitantly treated with a large number of other medicines.
Slovenian: S previdnostnega vidika to pomeni, da bolniki ne morejo biti sočasno varno zdravljeni z velikim številom drugih zdravil.
English: Thus, Study 3101 was the only positive short-term study exclusively conducted in schizophrenia patients.
Slovenian: Zato je bila študija 3101 edina pozitivna kratkoročna študija, izvedena izključno pri bolnikih s shizofrenijo.
English: It is not considered that the risk minimization measures proposed would appropriately address the risk identified in this specific case.
Slovenian: Velja, da predlagani ukrepi za zmanjševanje tveganja v tem posebnem primeru ne bi ustrezno odpravili ugotovljenega tveganja.
English: The efficacy of daily doses lower than 24 mg was insufficiently characterised.
Slovenian: Učinkovitost dnevnih odmerkov, manjših od 24 mg, ni bila zadostno opredeljena.
English: Several approaches to various data sets support the notion that full efficacy of Fanaptum is not achieved before Week 3.
Slovenian: Več pristopov k različnim naborom podatkov podpira stališče, da zdravilo Fanaptum svoje polne učinkovitosti ne doseže pred 3. tednom.
English: However, post-hoc analyses presented in support of this argument were based on patients completing at least 2 weeks of treatment, which is a different population from that originally assigned to treatment.
Slovenian: Vendar so naknadno predstavljene analize v podporo tej trditvi temeljile na bolnikih, ki so zaključili vsaj dvotedensko zdravljenje, kar pa ni enaka populacija kot tista, ki ji je bilo zdravljenje prvotno dodeljeno.
English: Iloperidone is also associated with a clinically significant body weight increase.
Slovenian: Iloperidon je povezan tudi s klinično pomembnim povečanjem telesne mase.
English: Therefore, the CHMP has recommended the refusal of the granting of the marketing authorisation for Fanaptum.
Slovenian: Odbor CHMP je zato priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Fanaptum.
English: Physicochemical and biological aspects relevant to the uniform clinical performance of the product have been investigated and are controlled in a satisfactory way.
Slovenian: Proučeni so bili fizikalno-kemijski in biološki vidiki, pomembni za enotno klinično učinkovitost zdravila, ki so zadovoljivo nadzorovani.
English: Additional data has been provided from the open-label Study US01 comparing two ways of switching to Fanaptum from another treatment, gradual (over two weeks) or immediate.
Slovenian: Dodatni podatki so bili pridobljeni iz odprte študije US01, v kateri so primerjali dva načina prehoda z drugega zdravljenja na zdravilo Fanaptum: postopnega (v več kot dveh tednih) ali takojšnjega.
English: An active comparator was included in studies 3000 (Haloperidol), 3004 and 3005 (Risperidone), and 3101 (Ziprasidone).
Slovenian: Aktivno primerjalno zdravilo je bilo vključeno v študije 3000 (haloperidol), 3004 in 3005 (risperidon) ter 3101 (ziprasidon).
English: Iloperidone and the metabolite P88 shows relatively high affinity for hERG channel (IC50 of 12.4 and 24.1 ng/mL).
Slovenian: Iloperidon in presnovek P88 kažeta sorazmerno visoko afiniteto do kanala hERG (IC50 12,4 in 24,1 ng/ml).
English: Therefore, and taking into account the overall safety and efficacy profile of Iloperidone a patient population cannot be identified where the benefit of treatment is considered to outweigh the major safety concerns.
Slovenian: Posledično ob upoštevanju celotnega varnostnega profila in profila učinkovitosti iloperidona ni mogoče določiti populacije bolnikov, pri kateri bi veljalo, da koristi zdravljenja odtehtajo glavne pomisleke o varnosti;
English: In addition, it has shown a delayed onset of action, which is a significant concern in the treatment of acute exacerbation of schizophrenia.
Slovenian: Poleg tega se je izkazalo, da ima zapoznel začetek delovanja, kar je pri zdravljenju akutnega poslabšanja shizofrenije pomemben pomislek.
English: Iloperidone is associated with extrapyramidal effects, but to a modest degree.
Slovenian: Iloperidon je povezan z ekstrapiramidnimi učinki, vendar do zmerne stopnje.
English: Thus, mechanisms that could potentially mitigate the prominent pro-arrhythmogenic potential of iloperidone are not present.
Slovenian: Zato mehanizmi, ki bi lahko morebiti zmanjšali največji proaritmogeni potencial iloperidona, niso prisotni.
English: • Quality
Slovenian: • Kakovost
English: However, Study 3004 also included patients with schizoaffective disorder and efficacy was not demonstrated in the schizophrenia subgroup.
Slovenian: Vendar so bili v študijo 3004 vključeni tudi bolniki s shizoafektivno motnjo in v podskupini bolnikov s shizofrenijo učinkovitost ni bila dokazana.
English: Based on the above, the risk-benefit balance of Iloperidone is considered negative.
Slovenian: se šteje na podlagi zgoraj navedenega razmerje med tveganji in koristmi iloperidona za negativno.
English: Thus, efficacy has not been convincingly established for 12 mg/day dose.
Slovenian: Zato učinkovitost za odmerek 12 mg/dan ni bila prepričljivo dokazana.
English: Furthermore, risperidone was still associated with a numerically superior effect estimate - even for patients treated for >2 weeks.
Slovenian: Poleg tega je bilo zdravilo risperidon še vedno povezano s številčno superiorno oceno učinka - tudi pri bolnikih, zdravljenih manj kot dva tedna.
English: The short-term efficacy of Fanaptum in patients with an acute episode of schizophrenia has been mainly characterised in five placebo-controlled studies.
Slovenian: Kratkoročni učinek zdravila Fanaptum pri bolnikih z akutno epizodo shizofrenije je bil v glavnem opredeljen v petih s placebom nadzorovanih študijah.
English: Similarly, at Week 2 it was 4.2 for ziprasidone i.e. almost full efficacy, whereas the difference was still only 2.8 for Fanaptum.
Slovenian: Podobno je v 2. tednu razlika pri ziprasidonu znašala 4,2 točke, kar je skoraj polna učinkovitost, za zdravilo Fanaptum pa je razlika še vedno bila le 2,8.
English: The quality of this product is considered to be acceptable when used in accordance with the conditions defined in the SmPC.
Slovenian: Kakovost zdravila Fanaptum je bila ocenjena za sprejemljivo, če se uporablja skladno s pogoji, opredeljenimi v povzetku glavnih značilnosti zdravila.
English: Annex I Scientific conclusions and grounds for refusal presented by the European Medicines Agency
Slovenian: Priloga I Znanstveni zaključki in podlaga za zavrnitev, ki jih je predstavila Evropska agencija za zdravila
English: Compared to other antipsychotics, Fanaptum has a late onset of action.
Slovenian: V primerjavi z drugimi antipsihotiki začne zdravilo Fanaptum delovati zapoznelo.
English: In consideration of the complex causal chain linking the exposure to Iloperidone to events such as Torsade de Pointes, including unknown and stochastic elements and elements subject to an unpredictable variability, it is considered that the risk minimization measures proposed would not adequately address in clinical practice the risk identified.
Slovenian: Ob upoštevanju zapletene vzročne verige, ki povezuje izpostavljenost iloperidonu z dogodki, kot so pojav torsade de pointes, vključno z neznanimi in stohastičnimi elementi ter elementi, odvisnimi od nepredvidljive spremenljivosti, velja, da predlagani ukrepi za zmanjševanje tveganj v klinični praksi ne bi zadostno odpravili ugotovljenih tveganj.
English: This indicates that Iloperidone could cause QT prolongation.
Slovenian: To kaže, da lahko iloperidon povzroči podaljšanje intervala QT.
English: PK-PD analyses presented were fundamentally flawed in that placebo patients were included with an assigned value of zero - impacting the results of the analysis.
Slovenian: Predstavljene analize PK-PD so imele temeljno napako: bolniki, ki so prejemali placebo, so bili vključeni z dodeljeno vrednostjo nič, kar je vplivalo na rezultate analize.
English: The overall nonclinical safety pharmacology data point to a risk of QT prolongation (hERG blockade, APD prolongation in dog Purkinje fibres).
Slovenian: Skupni neklinični farmakološki podatki o varnosti kažejo na tveganje podaljšanja intervala QT (blokado hERG, podaljšanje APD v Purkynějevih vlaknih pri psih).
English: However, the exposure in the dog studies appears to be lower than in the clinical setting, and therefore the absence of any QT prolongation in the in vivo dog studies is not considered to alleviate the concerns raised based on the in vitro studies.
Slovenian: Vendar se izpostavljenost v študijah pri psih zdi nižja kot v kliničnem okolju, zato odsotnost morebitnega podaljšanja intervala QT v študijah pri psih in vivo ne zadošča za odpravljanje izraženih pomislekov na podlagi študij in vitro.
English: However, as the randomised withdrawal study by design has to include the responders only i.e., the population is enriched, the magnitude of the effect can only be derived from the short term studies.
Slovenian: Ker pa mora randomizirana študija z naknadno prekinitvijo zdravljenja zaradi svoje zasnove vključevati samo bolnike z odzivom, kar pomeni, da je populacija obogatena, je mogoče obseg učinka ugotoviti le iz kratkoročnih študij.
English: However, this study - with an open label design and lacking of a group of patients randomised to a treatment other than Fanaptum or to placebo - was not designed to establish efficacy in patients switching from another treatment.
Slovenian: Vendar pa ta študija (z odprto zasnovo in brez skupine bolnikov, randomiziranih v zdravljenje, ki bi bilo različno od zdravljenja z zdravilom Fanaptum ali s placebom) ni bila zasnovana za ugotavljanje učinkovitosti pri bolnikih, ki so prešli na to zdravljenje z drugega zdravljenja.
English: Hence, the safety of Iloperidone has not been sufficiently demonstrated.
Slovenian: Zato varnost iloperidona ni bila zadostno dokazana;
English: The main safety issue with Iloperidone is that it causes QTc prolongation with the subsequent risks of arrhythmia and sudden death.
Slovenian: Glavna težava z varnostjo iloperidona je, da povzroča podaljšanje intervala QTc z naknadnim tveganjem aritmije in nenadne smrti.
English: In the clinical trial programme, 4.5% of the patients treated with iloperidone regardless of dose (4-24 mg/day) had an increase more than 60 msec at some time point.
Slovenian: V programu kliničnega preskušanja je povečanje pri 4,5 % bolnikov, zdravljenih z iloperidonom ne glede na odmerek (4-24 mg/dan) v določenem trenutku znašalo več kot 60 ms.
English: In this study, the PANSS reduction with Iloperidone 24 mg differed in a statistically significant manner from placebo at Week 4 but the magnitude of the effect was modest with a reduction of approximately 5 points on the PANNS-T scale compared to placebo.
Slovenian: V tej študiji se je zmanjšanje po ocenjevalni lestvici PANSS z iloperidonom v odmerku 24 mg v 4. tednu na statistično pomemben način razlikovalo od placeba, vendar je bil obseg učinka zmeren: v primerjavi s placebom je bilo zmanjšanje prisotno pri približno 5 točkah na ocenjevalni lestvici PANNS-T.
English: • Furthermore, Iloperidone has a modest efficacy.
Slovenian: • iloperidon je bil poleg tega zgolj zmerno učinkovit.
English: Unfortunately, the CYP2D6 genotype was not known in the patients that died during the clinical studies or post-marketing.
Slovenian: Žal pri bolnikih, ki so umrli med kliničnimi študijami ali v obdobju trženja, ni bil znan genotip CYP2D6.
English: Furthermore, as the metabolism of iloperidone relies heavily on CYP3A4 and CYP2D6, this creates the potential of increased exposure to the drug as a consequence of drug-drug interactions and genetic polymorphisms.
Slovenian: Ker je poleg tega presnova iloperidona v glavnem odvisna od encimov CYP3A4 in CYP2D6, se pojavi možnost povečane izpostavljenosti zdravilu kot posledica interakcij zdravila z zdravilom in genskih polimorfizmov.
English: The Applicant argued that the apparent difference between Fanaptum and risperidone could be partially due to a greater number of patients on Fanaptum discontinuing early due to lack of efficacy during titration.
Slovenian: Predlagatelj je trdil, da je očitna razlika med zdraviloma Fanaptum in risperidon lahko delno nastala zaradi večjega števila bolnikov, zdravljenih z zdravilom Fanaptum, ki so zaradi neučinkovitosti med titracijo predčasno prenehali zdravljenje.
English: For instance, in Study 3101 where full effect vs placebo would correspond to a reduction of 5 PANSS-T points, it is remarkable that the difference at Week 1 was already 2.4 for ziprasidone, whereas it was 0.1 for Fanaptum.
Slovenian: V študiji 3101, pri kateri polni učinek v primerjavi s placebom ustreza zmanjšanju za 5 točk pri ocenjevanju z lestvico PANSS-T, je na primer izjemno, da je razlika v 1. tednu za ziprasidon znašala že 2,4 točke, za zdravilo Fanaptum pa 0,1.
English: Acknowledging the relationship between QTc prolongation (and the connected risks) and exposure, the Applicant proposed for this re-examination a contraindication in CYP2D6 poor metabolisers or in those patients with unknown CYP2D6 metaboliser status, and for concomitant use with drugs that are known strong CYP2D6 or CYP3A4 inhibitors.
Slovenian: Predlagatelj je ob priznavanju razmerja med podaljšanjem intervala QTc (in povezanih tveganj) in izpostavljenosti za ta ponovni pregled predlagal kontraindikacijo pri osebah, ki slabo presnavljajo prek encima CYP2D6, ali pri bolnikih, pri katerih stanje presnavljanja prek encima CYP2D6 ni znano, in sočasno uporabo z zdravili, za katere je znano, da so močni zaviralci CYP2D6 ali CYP3A4.
English: For example, the proposal to perform ECGs at the estimated Tmax could miss the actual Tmax due to intrinsic or extrinsic factors, leading to an underestimation of the QTcF prolongation.
Slovenian: Predlog za opravljanje EKG pri ocenjeni vrednosti Tmax bi lahko zaradi intrinzičnih ali ekstrinzičnih dejavnikov zgrešil dejansko vrednost Tmax, zaradi česar bi bilo podaljšanje intervala QTcF podcenjeno.
English: In addition, whether the correct implementation of the complete set of measures would be feasible in all clinical settings is questionable due to practical reasons (for example the availability of suitably trained cardiologists), as also mentioned by the Experts in the ad-hoc meeting.
Slovenian: Poleg tega je iz praktičnih razlogov (na primer razpoložljivosti primerno usposobljenih kardiologov) vprašljivo, ali bi bilo mogoče v vseh kliničnih okoljih doseči pravilno uvedbo celotnega nabora ukrepov, kar so navedli tudi strokovnjaki na priložnostnem sestanku.
English: Of those, three - B202, 3000, and 3005 - failed to show superiority over placebo according to their pre-specified primary endpoints and analysis plans, and two3004 and 3101 - met their pre-specified criteria for superiority over placebo.
Slovenian: Od teh študij v treh (B202, 3000, in 3005) niso dokazali superiornosti v primerjavi s placebom glede na njihove predhodno določene opazovane dogodke in načrte analize, v dveh (3004 in 3101) pa so bila izpolnjena predhodno določena merila za superiornost v primerjavi s placebom.
English: In conclusion, Iloperidone has a substantial arrhythmogenic potential, which becomes obvious if all available non-clinical and clinical data (including the thorough QTc study, the overall clinical program and also the cases of cardiac-related/sudden unexplained death in clinical trials and post-marketing) are taken into account.
Slovenian: Zaključek je, da ima iloperidon znaten aritmogeni potencial, ki postane očiten z upoštevanjem vseh razpoložljivih nekliničnih in kliničnih podatkov (vključno s temeljito študijo intervala QTc, celotnim kliničnim programov ter tudi s primeri s srcem povezane/nenadne nepojasnjene smrti v kliničnih preskušanjih in obdobju trženja).
English: • Considering all available non-clinical and clinical data (including the thorough QTc study, the overall clinical program and the cases of cardiac-related/sudden unexplained death in clinical trials and post-marketing), Iloperidone has a substantial and exposure-dependent arrhythmogenic potential.
Slovenian: • z upoštevanjem vseh razpoložljivih nekliničnih in kliničnih podatkov (vključno s temeljito študijo intervala QTc, celotnim kliničnim programov ter tudi s primeri s srcem povezane/nenadne nepojasnjene smrti v kliničnih preskušanjih in obdobju trženja), ima iloperidon znaten in od izpostavljenosti odvisen aritmogeni potencial.