FrancophonIA/ELRC3.0 huggingface dataset:
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above.
Croatian: Ne postoje dostupni podaci o neškodljivosti i djelotvornosti ovog cjepiva kada se primjenjuje s bilo kojim drugim veterinarsko-medicinskim proizvodom, osim s gore navedenim proizvodom.
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed with ReproCyc PRRS EU and administered at one injection site.
Croatian: Podaci o neškodljivosti i djelotvornosti su dostupni i pokazuju da se ovo cjepivo može primijeniti pomiješano s proizvodom ReproCyc PRRS EU na jednom mjestu injekcije.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated , including isolated reports).
Croatian: Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojavu(e)) - česte (više od 1 ali manje od 10 životinja na 100 tretiranih životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 tretiranih životinja) - rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja ) - vrlo rijetke (manje od 1 životinje na 10.000 tretiranih životinja, uključujući izolirane slučajeve).
English: This vaccine is designed to stimulate the development of an active immune response in pigs to porcine parvovirus.
Croatian: Ovo cjepivo namijenjeno je za stimulaciju razvoja aktivnog imunološkog odgovora u svinja na parvovirus svinja.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Croatian: Bilo koji neupotrjebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobiveni primjenom tih veterinarsko-medicinskih proizvoda trebaju se odlagati u skladu s lokalnim propisima.
English: Re-vaccination scheme:
Croatian: Shema ponovnog cijepljenja:
English: Store and transport refrigerated (2 °C - 8 C).
Croatian: Čuvati i prevoziti na hladnom (2 °C - 8 C).
English: The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Regulation (EC) 470/2009.
Croatian: Djelatna tvar se sastoji od tvari biološkog podrijetla, koje su namijenjene za stvaranje aktivne imunosti i na koje se ne primjenjuju odredbe Uredbe (EK) br. 470/2009.
English: Do not mix with any other veterinary medicinal product, except with ReproCyc PRRS EU.
Croatian: Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom, osim s proizvodom ReproCyc PRRS EU.
English: For pigs previously non-vaccinated against porcine parvovirus: Two intramuscular injections of one dose, 3 weeks apart.
Croatian: Za svinje koje nisu prethodno cijepljene protiv parvovirusa svinja: Dvije intramuskularne injekcije jedne doze, u razmaku od 3 tjedna.
English: One intramuscular injection of one dose at least every 6 months is recommended in a whole herd programme (see section 4.2).
Croatian: Shema ponovnog cijepljenja: Jedna intramuskularna injekcija jedne doze najmanje svakih 6 mjeseci, preporučuje se u programu za cijelo krdo (vidjeti odjeljak 4.2).
English: Store and transport refrigerated (2 C-8 C).
Croatian: Čuvati i prevoziti na hladnom (2 C - 8 C).
English: 4.7 Use during pregnancy, lactation and lay
Croatian: 4.7 Primjena tijekom graviditeta, laktacije ili nesenja
English: DATE OF AUTHORISATION/RENEWAL OF THE AUTHORISATION
Croatian: DATUM PRVOG ODOBRENJA/PRODULJENJA ODOBRENJA
English: ReproCyc ParvoFLEX hereby replaces the solvent of ReproCyc PRRS EU.
Croatian: ReproCyc ParvoFLEX time zamjenjuje otapalo za ReproCyc PRRS EU.
English: Sodium chloride Water for injections Potassium chloride Potassium dihydrogen phosphate Disodium phosphate anhydrous
Croatian: Natrijev klorid Voda za injekcije Kalijev klorid Kalijev dihidrogenfosfat Dinatrijev fosfat, bezvodni
English: Each dose (2 ml) contains:
Croatian: Svaka doza (2 ml) sadržava:
English: Adjuvant: Carbomer 2 mg
Croatian: Karbomer 2 mg
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case-by-case basis.
Croatian: Odluku o primjeni ovog cjepiva prije, odnosno poslije primjene bilo kojeg drugog veterinarsko-medicinskog proizvoda treba donositi od slučaja do slučaja.
English: One dose (2 ml) contains:
Croatian: Jedna doza (2 ml) sadržava:
English: Boehringer Ingelheim Vetmedica GmbH GERMANY
Croatian: Boehringer Ingelheim Vetmedica GmbH NJEMAČKA
English: Administer a single dose (2 ml) of the mixture intramuscularly.
Croatian: Intramuskularno primijenite jednu dozu (2 ml) mješavine.
English: For active immunisation of gilts and sows from the age of 5 months to protect progeny against transplacental infection caused by porcine parvovirus.
Croatian: Za aktivnu imunizaciju nazimica i krmača starijih od 5 mjeseci da bi se potomci zaštitili od transplacentalne infekcije uzrokovane parvovirusom svinja.
English: One dose (2 ml): Porcine Parvovirus VP2 subunit antigen Carbomer
Croatian: Jedna doza (2 ml): parvovirus svinja, subjedinični antigen VP2 Karbomer
English: The full content of one vial of ReproCyc ParvoFLEX should be used to reconstitute the lyophilisate of one vial of ReproCyc PRRS EU.
Croatian: Cijeli sadržaj jedne bočice proizvoda ReproCyc ParvoFLEX treba upotrijebiti za rekonstituciju liofilizata jedne bočice proizvoda ReproCyc PRRS EU.
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)
Croatian: 20 ml (10 doza) 100 ml (50 doza) 200 ml (100 doza) 12 x 20 ml (12 x 10 doza) 12 x 100 ml (12 x 50 doza) 12 x 200 ml (12 x 100 doza)
English: Duration of immunity: 6 months
Croatian: Trajanje imunosti:
English: 100 doses
Croatian: 100 doza
English: 2 years
Croatian: 6 mjeseci.
English: Pharmacotherapeutic group: Immunologicals for Suidae, inactivated viral vaccines, porcine parvovirus ATCvet code: QI09AA02
Croatian: Farmakoterapijska grupa: imunološki proizvodi za Suidae, inaktivirana virusna cjepiva, parvovirus svinja
English: ReproCyc ParvoFLEX suspension for injection
Croatian: ReproCyc ParvoFLEX suspenzija za injekciju
English: Primary vaccination scheme:
Croatian: Shema prvog cijepljenja:
English: 6.6 Special precautions for the disposal of unused medicinal product or waste materials derived from the use of such products
Croatian: 6.6 Posebne mjere opreza prilikom odlaganja neupotrjebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala dobivenih primjenom tih proizvoda
English: 20 ml bottle
Croatian: Bočica od 20 ml
English: Mixing with ReproCyc PRRS EU:
Croatian: Miješanje s ReproCyc PRRS EU:
English: ReproCyc ParvoFLEX suspension for injection for pigs
Croatian: ReproCyc ParvoFLEX suspenzija za injekciju za svinje
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Croatian: 13. POSEBNE MJERE OPREZA PRILIKOM ODLAGANJA NEUPOTRJEBLJENOG PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA
English: SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
Croatian: 12. POSEBNE MJERE OPREZA PRI ODLAGANJU NEUPOTRJEBLJENIH PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA
English: Colourless to slightly brown, opalescent suspension for injection.
Croatian: Bezbojna do blago smeđa, zamućena otopina za injekciju.
English: Shelf life after mixing with ReproCyc PRRS EU:
Croatian: Rok valjanosti poslije miješanja s proizvodom ReproCyc PRRS EU:
English: Name and address of the manufacturers responsible for batch release Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
Croatian: Naziv i adresa proizvođača odgovornih za puštanje serije u promet Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
English: Porcine Parvovirus VP2 subunit antigen: ≥ 1.0 RP* * Relative Potency (ELISA) Carbomer 2 mg.
Croatian: Parvovirus svinja, subjedinični antigen VP2: ≥ 1,0 RP* * Relativna potentnost (ELISA test) Karbomer 2 mg.
English: 100 ml (50 doses) 200 ml (100 doses)
Croatian: 100 ml (50 doza) 200 ml (100 doza)
English: 100 doses (200 ml)
Croatian: 100 doza (200 ml)
English: The package leaflet of ReproCyc PRRS EU should also be consulted before the administration of the mixed product.
Croatian: Prije primjene pomiješanog proizvoda potrebno je proučiti i uputu o VMP ReproCyc PRRS EU.
English: 100 ml, 200 ml bottle
Croatian: Bočica od 100 ml, 200 ml
English: Porcine Parvovirus strain 27a VP2 subunit antigen: ≥ 1.0 RP* * Relative potency (ELISA).
Croatian: Parvovirus svinja soj 27a subjedinični antigen VP2: ≥ 1,0 RP* * Relativna potentnost (ELISA test).
English: Carton of 20 ml, 100 ml, 200 ml bottles
Croatian: Kutija s bočicama od 20 ml, 100 ml, 200 ml
English: Colourless to slightly brown, opalescent suspension.
Croatian: Bezbojna do blago smeđa, zamućena otopina.
English: PACKAGE LEAFLET: ReproCyc ParvoFLEX suspension for injection for pigs
Croatian: UPUTA O VMP: ReproCyc ParvoFLEX suspenzija za injekciju za svinje
English: High density polyethylene bottles containing 20 ml (10 doses), 100 ml (50 doses) and 200 ml (100 doses).
Croatian: Bočice od polietilena velike gustoće sadržavaju 20 ml, (10 doza), 100 ml (50 doza) i 200 ml (100 doza).
English: 1 bottle of 20 ml (10 doses), 100 ml (50 doses) or 200 ml (100 doses).
Croatian: 1 bočica od 20 ml (10 doza), 100 ml (50 doza) ili 200 ml (100 doza).
English: 1 bottle of 20 ml (10 doses), 100 ml (50 doses) or 200 ml (100 doses) packed in a cardboard box.
Croatian: 1 bočica od 20 ml (10 doza), 100 ml (50 doza) ili 200 ml (100 doza) zapakirana u kartonsku kutiju.
English: 12 bottles of 20 ml (10 doses), 100 ml (50 doses) or 200 ml (100 doses) packed in a cardboard box.
Croatian: 12 bočica od 20 ml (10 doza), 100 ml (50 doza) ili 200 ml (100 doza) zapakiranih u kartonsku kutiju.
English: 12 bottles of 20 ml (10 doses), 100 ml (50 doses) or 200 ml (100 doses).
Croatian: 12 bočica od 20 ml (10 doza), 100 ml (50 doza) ili 200 ml (100 doza).
English: Shelf life of the veterinary medicinal product as packaged for sale:
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: 2 godine Rok valjanosti poslije prvog otvaranja unutarnjeg pakovanja:
English: Name and address of the manufacturer of the biological active substance Boehringer Ingelheim Vetmedica Inc.
Croatian: Nositelj odobrenja za stavljanje u promet i proizvođač odgovoran za puštanje serije u promet: Boehringer Ingelheim Vetmedica GmbH
English: Grounds for refusal
Croatian: Razlozi za odbijanje
English: Late onset of action is regarded as a considerable drawback.
Croatian: Kasniji početak djelovanja smatra se znatnim nedostatkom.
English: Haloperidol and Risperidone.
Croatian: Haloperidolom i Risperidonom.
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.
Croatian: Mišljenje je CHMP-a da, sukladno članku 12. Uredbe (EZ) br. 726/2004, sigurnost prethodno navedenog lijeka nije ispravno ili dovoljno dokazana.
English: Scientific conclusions and grounds for refusal presented by the European Medicines Agency
Croatian: Znanstveni zaključci i razlozi za odbijanje koje je iznijela Europska agencija za lijekove
English: • Non-clinical
Croatian: • Neklinički podatci
English: In addition, there is at least one literature case report of arrhythmia.
Croatian: Osim toga, u literaturi je zabilježen najmanje jedan slučaj aritmije.
English: As 4423 patients were exposed to Iloperidone, this accounts for 0.14% of all treated patients.
Croatian: Budući da su 4 423 bolesnika bila izložena Iloperidonu, to je 0,14 % svih liječenih bolesnika.
English: • Safety
Croatian: • Sigurnost
English: • Efficacy
Croatian: • Djelotvornost
English: Physicochemical and biological aspects relevant to the uniform clinical performance of the product have been investigated and are controlled in a satisfactory way.
Croatian: Fizikalno-kemijski i biološki aspekti bitni u pogledu jedinstvenog kliničkog utjecaja lijeka ispitani su i kontroliraju se na zadovoljavajući način.
English: Thus, efficacy has not been convincingly established for 12 mg/day dose.
Croatian: Stoga djelotvornost nije uvjerljivo utvrđena za dozu od 12 mg/dan.
English: It is not considered that the risk minimization measures proposed would appropriately address the risk identified in this specific case.
Croatian: Smatra se da predložene mjere svođenja rizika na najmanju moguću mjeru ne bi prikladno riješile rizike utvrđene u ovom pojedinom slučaju.
English: Thus, Study 3101 was the only positive short-term study exclusively conducted in schizophrenia patients.
Croatian: Stoga je ispitivanje 3101 bilo jedino pozitivno kratkoročno ispitivanje provedeno isključivo na bolesnicima sa shizofrenijom.
English: There were 33 deaths of which 3 patients died during sleep, 6 were sudden deaths, and 6 cases were of cardiac origin.
Croatian: Zabilježena su 33 smrtna slučaja, od čega su tri bolesnika preminula u snu, u njih šest došlo je do iznenadne smrti, a u šest slučajeva smrt je bila povezana sa srčanim problemima.
English: Iloperidone is also associated with a clinically significant body weight increase.
Croatian: Iloperidon je povezan i s klinički značajnim povećanjem tjelesne težine.
English: Overall summary of the scientific evaluation of Fanaptum
Croatian: Cjelokupan sažetak znanstvene ocjene lijeka Fanaptum
English: In conclusion, there was no robust support for statements concerning dose-response relationship below 24 mg/day (the dose used in study 3101).
Croatian: Zaključno, nije bilo dovoljno pouzdanih dokaza za tvrdnje o odnosu doza i odgovora za doze manje od 24 mg/dan (doza korištena u ispitivanju 3101).
English: Several approaches to various data sets support the notion that full efficacy of Fanaptum is not achieved before Week 3.
Croatian: Razni pristupi brojnim skupovima podataka dovode do zaključka da se potpuna djelotvornost Fanaptuma ne postiže prije trećega tjedna.
English: However, no correction for multiplicity was performed when evaluating individual doses.
Croatian: Međutim, pri procjeni pojedinačnih doza nije proveden ispravak višestrukosti.
English: The efficacy of daily doses lower than 24 mg was insufficiently characterised.
Croatian: Djelotvornost dnevnih doza manjih od 24 mg nije dostatno utvrđena.
English: However, Study 3004 also included patients with schizoaffective disorder and efficacy was not demonstrated in the schizophrenia subgroup.
Croatian: Međutim, ispitivanje 3004 uključivalo je i bolesnike sa shizoafektivnim poremećajem i djelotvornost nije dokazana u podskupini sa shizofrenijom.
English: Unfortunately, the CYP2D6 genotype was not known in the patients that died during the clinical studies or post-marketing.
Croatian: Nažalost, genotip CYP2D6 nije bio poznat u bolesnika koji su umrli tijekom kliničkih ispitivanja ili nakon stavljanja lijeka u promet.
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.
Croatian: Dodatni podatci dobiveni su iz ispitivanja otvorena tipa US01, usporedbom dvaju načina prelaska na Fanaptum s drugog liječenja, postupnoga (u razdoblju od dva tjedna) i neposrednoga.
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.
Croatian: Međutim, post-hoc analize koje su predstavljene u korist ovog argumenta temeljene su na pritužbama bolesnika koji su podvrgnuti liječenju u trajanju od barem dva tjedna, a ta je populacija različita od one kojoj je liječenje prvotno namijenjeno.
English: However, the metabolism of Iloperidone is still of concern in relation to its exposure-dependent risks.
Croatian: Međutim, metabolizam Iloperidona i dalje je zabrinjavajuć u odnosu na rizike povezane s izloženošću.
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.
Croatian: Osim toga, upitno je bi li točna primjena cjelokupnog niza mjera bila izvediva u svim kliničkim okruženjima, i to zbog praktičnih razloga (npr., dostupnost kardiologa s odgovarajućom obukom), što su stručnjaci također spomenuli na ad-hoc sastanku.
English: Therefore, the CHMP has recommended the refusal of the granting of the marketing authorisation for Fanaptum.
Croatian: Stoga je CHMP preporučio odbijanje izdavanja odobrenja za stavljanje lijeka Fanaptum u promet.
English: This means that, from a precautionary approach, patients could not safely be concomitantly treated with a large number of other medicines.
Croatian: Primjenjujući oprezan pristup, to znači da se bolesnici ne bi mogli na siguran način kombinirano liječiti brojnim drugim lijekovima.
English: Based on the above, the risk-benefit balance of Iloperidone is considered negative.
Croatian: Na temelju navedenoga, omjer koristi i rizika Iloperidona smatra se negativnim.
English: An active comparator was included in studies 3000 (Haloperidol), 3004 and 3005 (Risperidone), and 3101 (Ziprasidone).
Croatian: Aktivni usporedni lijek uključen je u ispitivanja 3000 (Haloperidol), 3004 i 3005 (Risperidon) te 3101 (Ziprasidon).
English: Continued, long-term efficacy after stabilisation with Fanaptum has been studied and demonstrated in Study 2301, in which patients continuing on Fanaptum had a significantly lower rate of relapses or impending relapses compared to patients switched to placebo.
Croatian: Kontinuirana i dugotrajna djelotvornost nakon stabilizacije Fanaptumom proučavana je i prikazana u ispitivanju 2301, u kojemu su bolesnici koji su nastavili upotrebljavati Fanaptum imali znatno nižu razinu relapsa ili skorih relapsa u usporedbi s bolesnicima koji su prebačeni na placebo.
English: • Quality
Croatian: • Kvaliteta
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.
Croatian: Slično tomu, u drugom je tjednu razlika za Ziprasidon iznosila 4,2, što je gotovo potpuna djelotvornost, dok je razlika za Fanaptum i dalje iznosila samo 2,8.
English: Very little detailed information is available from the post-marketing setting.
Croatian: Ne postoji dovoljno detaljnih informacija o uvjetima nakon stavljanja lijeka u promet.
English: The short-term efficacy of Fanaptum in patients with an acute episode of schizophrenia has been mainly characterised in five placebo-controlled studies.
Croatian: Kratkoročna djelotvornost Fanaptuma u bolesnika s akutnom epizodom shizofrenije uglavnom je utvrđena u pet ispitivanja kontroliranih placebom.
English: Although comparative efficacy was not the primary objective of those studies, the magnitude of effect of Fanaptum appeared similar to Ziprasidone but compared negatively with
Croatian: Iako komparativna djelotvornost nije primarni cilj tih ispitivanja, čini se da je razmjer učinka Fanaptuma sličan onomu Ziprasidona, ali imao je negativne rezultate u usporedbi s
English: Thus, mechanisms that could potentially mitigate the prominent pro-arrhythmogenic potential of iloperidone are not present.
Croatian: Stoga mehanizmi koji bi mogli smanjiti istaknuti proaritmogeni potencijal Iloperidona nisu prisutni.
English: Compared to other antipsychotics, Fanaptum has a late onset of action.
Croatian: U usporedbi s drugim antipsihoticima, djelovanje Fanaptuma počinje kasnije.
English: The overall nonclinical safety pharmacology data point to a risk of QT prolongation (hERG blockade, APD prolongation in dog Purkinje fibres).
Croatian: Ukupni neklinički podatci sigurnosne farmakologije upućuju na rizik od produljenja QT intervala (hERG blokada, APD produljenje Purkinjeovih vlakana u pasa).
English: It is currently unknown if Iloperidone can be safely administered with weak and/or moderate inhibitors of CYP2D6 and/or CYP3A4 given the likely variability of the efficiency of minor metabolic pathways.
Croatian: Trenutačno nije poznato je li sigurno primjenjivati Iloperidon uz slabe i/ili umjerene inhibitore CYP2D6 i/ili CYP3A4 zbog vjerojatne varijabilne djelotvornosti manjih metaboličkih putova.
English: In summary, the safety of Iloperidone has not been sufficiently demonstrated.
Croatian: Ukratko, sigurnost Iloperidona nije dostatno dokazana.
English: Iloperidone and the metabolite P88 shows relatively high affinity for hERG channel (IC50 of 12.4 and 24.1 ng/mL).
Croatian: P88 pokazuju relativno visok stupanj vezivanja na hERG kanal (IC50 od 12,4 i 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.
Croatian: Stoga, uzimajući u obzir ukupnu sigurnost i profil djelotvornosti Iloperidona, ne može se utvrditi postojanje populacije bolesnika u kojoj korist lijeka nadmašuje razloge za ozbiljnu zabrinutost.
English: • Furthermore, Iloperidone has a modest efficacy.
Croatian: • Nadalje, Iloperidon ima ograničenu djelotvornost.
English: The main safety issue with Iloperidone is that it causes QTc prolongation with the subsequent risks of arrhythmia and sudden death.
Croatian: Glavni sigurnosni problem u pogledu Iloperidona jest taj da uzrokuje produljenje QTc intervala s naknadnim rizikom od aritmije i iznenadne smrti.
English: Iloperidone is associated with extrapyramidal effects, but to a modest degree.
Croatian: Iloperidon je povezan s ekstrapiramidalnim učincima, ali u ograničenoj mjeri.
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.
Croatian: Podnositelj zahtjeva tvrdio je da se očita razlika između Fanaptuma i Risperidona djelomično može pripisati činjenici da je kod većeg broja bolesnika liječenje ranije prekinuto zbog nedostatka djelotvornosti tijekom titracije.
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.
Croatian: Međutim, to ispitivanje, koje je otvorenog tipa i u kojemu nedostaje randomizirana skupina bolesnika za liječenje lijekovima koji nisu Fanaptum ili placebo, nije osmišljeno za utvrđivanje djelotvornosti u bolesnika koji prelaze s drugog liječenja.
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.
Croatian: U tom se ispitivanju smanjenje PANSS-a uporabom Iloperidona od 24 mg statistički značajno razlikovalo od smanjenja uporabom placeba u četvrtom tjednu, no razmjer djelotvornosti bio je umjeren, uz smanjenje od otprilike pet bodova na ljestvici PANSS-T u usporedbi s placebom.
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.
Croatian: Na primjer, uporabom prijedloga za obavljanje EKG-a uz procijenjen Tmax mogao bi se izbjeći stvarni Tmax zbog unutarnjih ili vanjskih čimbenika, što bi moglo dovesti do prekomjerno niske procjene produljenja QTcF intervala.