FrancophonIA/ELRC3.0 huggingface dataset:
English: rd trimester of pregnancy mean values of these parameters were comparable.
Croatian: Tijekom drugog i trećeg tromjesečja trudnoće, srednje vrijednosti ovih parametara bile su usporedive.
English: The proportion of paediatric patients with < 400 HIV-1 RNA copies/ml was 63.4%.
Croatian: Udio pedijatrijskih bolesnika s < 400 HIV-1 RNK kopija/ml bio je 63,4%.
English: As a general rule, when deciding to use antiretroviral agents for the treatment of HIV infection in pregnant women, and consequently for reducing the risk of HIV vertical transmission to the newborn, the animal data as well as the clinical experience in pregnant women should be taken into account in order to characterise the safety for the foetus.
Croatian: Kao opće pravilo pri donošenju odluke o primjeni antiretrovirusnih lijekova za liječenje HIV infekcije u trudnica te posljedično radi smanjenja rizika vertikalnog prijenosa HIV-a na novorođenče, potrebno je uzeti u obzir podatke iz ispitivanja na životinjama kao i klinička iskustva kod trudnica kako bi se odredila sigurnost za plod.
English: The recommended dose of etravirine for adults is 200 mg (one 200 mg tablet or two 100 mg tablets) taken orally twice daily following a meal (see section 5.2).
Croatian: Preporučena doza etravirina za odrasle je 200 mg (jedna tableta od 200 mg ili dvije tablete od 100 mg), peroralno, dva puta dnevno nakon obroka (vidjeti dio 5.2).
English: INTELENCE and darunavir/ritonavir can be used without dose adjustments (see also section 5.1).
Croatian: INTELENCE i darunavir/ritonavir mogu se primjenjivati bez prilagodbe doze (vidjeti također dio 5.1).
English: Itraconazole Ketoconazole Posaconazole
Croatian: Itrakonazol Ketokonazol Posakonazol
English: Confidence interval around observed difference of response rates; P-value < 0.0001 from logistic regression model, including stratification factors.
Croatian: Interval pouzdanosti oko opažene razlike u stopama odgovora; P-vrijednost < 0,0001 za model logističke regresije, uključujući faktore stratifikacije.
English: INTELENCE belongs to a group of anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Croatian: INTELENCE pripada skupini lijekova protiv HIV-a zvanih nenukleozidni inhibitori reverzne transkriptaze (NNRTI).
English: Etravirine binds directly to reverse transcriptase (RT) and blocks the RNA-dependent and DNA-dependent DNA polymerase activities by causing a disruption of the enzyme's catalytic site.
Croatian: Etravirin se veže izravno na reverznu transkriptazu (RT) i blokira aktivnosti DNK polimeraze koje su ovisne o RNK i DNK narušavanjem katalitičkog mjesta enzima.
English: No interaction between pravastatin and etravirine is expected.
Croatian: Ne očekuje se interakcija između pravastatina i etravirina.
English: Please contact your doctor immediately if you experience these symptoms.
Croatian: Molimo Vas da se odmah javite svom liječniku ako Vam se pojave ti simptomi.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections and Pneumocystis jiroveci pneumonia.
Croatian: Značajniji primjeri su citomegalovirusmi retinitis, generalizirane i/ili žarišne mikobakterijske infekcije i pneumonija kojoj je uzrok Pneumocystis jirovecii.
English: Note: The median protein binding adjusted EC50 for MT4 cells infected with HIV-1/IIIB in vitro = 4 ng/ml.
Croatian: Napomena: Medijan vezanja proteina prilagođen prema EC50 za MT4 stanice zaražene s HIV-1/IIIB in vitro = 4 ng/ml.
English: In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Croatian: U nekih bolesnika s uznapredovalom HIV infekcijom i oportunističkom infekcijom u povijesti, mogu se pojaviti znakovi i simptomi upale prijašnjih infekcija ubrzo nakon početka anti-HIV liječenja.
English: For instructions on dispersion of the medicinal product before administration, see section 6.6.
Croatian: Za uputu o rastapanju lijeka prije primjene vidjeti dio 6.6
English: CORTICOSTEROIDS Dexamethasone (systemic)
Croatian: KORTIKOSTEROIDI Deksametazon (sistemski)
English: The week 48 results from the pooled analysis of DUET-1 and DUET-2 demonstrated that the etravirine arm was superior to the placebo arm irrespective of whether ENF was used de novo (p = 0.0199) or not (p < 0.0001).
Croatian: Rezultati analize podataka iz 48. tjedna ispitivanja DUET-1 i DUET-2 pokazali su da je skupina koja je primala etravirin bila superiorna u odnosu na skupinu koja je primala placebo bez obzira na to je li ENF primjenjivan (p = 0,0199) ili nije primjenjivan (p < 0,0001) de novo.
English: The clinical significance of the reductions in etravirine pharmacokinetic parameters and boceprevir Cmin in the setting of the combination therapy with HIV antiretroviral medicines which also affect the pharmacokinetics of etravirine and/or boceprevir has not been directly assessed.
Croatian: Klinički značaj redukcije farmakokinetičkih parametara etravirina i Cmin boceprevira prilikom kombiniranog liječenja antiretrovirusnim HIV lijekovima koji također utječu na farmakokinetiku etravirina i/ili boceprevira, nije izravno procijenjen.
English: Weight and increased blood lipids and glucose
Croatian: Težina i povišeni lipidi i glukoza u krvi
English: Although etravirine demonstrates in vitro activity against wild type HIV-2 with median EC50 values ranging from 5.7 to 7.2 µM, treatment of HIV-2 infection with etravirine is not recommended in the absence of clinical data.
Croatian: Iako etravirin in vitro pokazuje djelovanje protiv divljeg tipa HIV-2 uz srednju vrijednost EC50 u rasponu od 5,7 do 7,2 µM, ne preporučuje se liječenje infekcije HIV-2 etravirinom budući da ne postoje klinički podaci.
English: The dosages of some medicines might need to be changed since their therapeutic effect or side effects may be influenced when combined with INTELENCE.
Croatian: Može biti potrebno promijeniti doze nekih lijekova s obzirom da se ne može utjecati na njihov terapijski učinak ili nuspojave kada se kombinriaju s lijekom INTELENCE.
English: Close monitoring of antimalarial response is warranted when co-administering INTELENCE and artemether/lumefantrine as a significant decrease in exposure of artemether and its active metabolite, dihydroartemisinin, may result in decreased antimalarial efficacy.
Croatian: Opravdano je pažljivo praćenje antimalarijskog odgovora kada se INTELENCE istodobno primjenjuje s artemeter/lumefantrinom jer značajno smanjenje izloženosti artemeteru i njegovom aktivnom metabolitu, dihidroartemisininu, može rezultirati smanjenom antimalarijskom djelotvornošću.
English: These trials were identical in design and similar efficacy for etravirine was seen in each trial.
Croatian: Ta su ispitivanja identično ustrojena i u oba ispitivanja opažena je slična djelotvornost etravirina.
English: The most common adverse reaction leading to discontinuation was rash.
Croatian: Najčešća nuspojava koja je dovodila do prekida liječenja bila je osip.
English: Haemorrhagic cardiomyopathy was only observed in male mice and was considered to be secondary to severe coagulopathy mediated via the vitamin K pathway.
Croatian: Hemoragijska kardiomiopatija bila je opažena samo u mužjaka i smatrala se sekundarnom, odnosno nastalom kao posljedica teške koagulopatije posredovane putem vitamina K.
English: No studies on the effects of INTELENCE on the ability to drive or operate machines have been performed.
Croatian: Nisu provedena ispitivanja učinka lijeka INTELENCE na sposobnost upravljanja vozilima ili rada sa strojevima.
English: INTELENCE should be used with caution in these patients (see also sections 4.4 and 5.2).
Croatian: U tih bolesnika INTELENCE treba primjenjivati s oprezom (vidjeti također dijelove 4.4 i 5.2).
English: 6 weeks after opening the bottle.
Croatian: 6 tjedana nakon otvaranja boce.
English: All ranges
Croatian: Svi rasponi
English: Paediatric population (6 years to less than 18 years of age)
Croatian: Pedijatrijska populacija (u dobi od 6 godina do manje od 18 godina)
English: There is no specific antidote for overdose with etravirine.
Croatian: Ne postoji poseban antidot za predoziranje etravirinom.
English: The population pharmacokinetic estimates for etravirine AUC12h and C0h are summarised in the table below.
Croatian: Populacijska farmakokinetička procjena za AUC12h i C0h etravirina prikazana je sažeto u tablici ispod.
English: In the Phase III studies, the rates of discontinuation due to any adverse reaction were 7.2% in patients receiving etravirine.
Croatian: U ispitavanju faze III, učestalosti prekida primjene lijeka zbog nuspojava bile su 7,2% u bolesnika koji su primali etravirin.
English: Data from the DUET studies suggest that baseline fold change (FC) in EC50 to etravirine was a predictive factor of virologic outcome, with gradually decreasing responses observed above FC 3 and FC 13.
Croatian: Podaci ispitivanja DUET pokazuju da je početni stupanj promjene (engl. fold change, FC) u vrijednosti EC50 za etravirin bio prediktor virološkog ishoda, uz postupno smanjenje odgovora opaženo iznad FC 3 i FC 13.
English: Effects on unbound exposure could be expected (has not been studied) and therefore caution is advised in patients with moderate hepatic impairment.
Croatian: Može se očekivati učinak zbog izloženosti nevezanom dijelu (što još nije bilo ispitivano) i stoga se preporuča oprez kod bolesnika s umjerenim poremećajem jetre.
English: Patients who are unable to swallow the tablet(s) whole may disperse the tablet(s) in a glass of water.
Croatian: Bolesnici koji ne mogu progutati cijelu tabletu(e) mogu tabletu(e) rastopiti u čaši vode.
English: HEPATITIS C VIRUS (HCV) DIRECT-ACTING ANTIVIRALS Ribavirin
Croatian: ANTIVIRUSNI LIJEKOVI IZRAVNOG UČINKA NA HEPATITIS C VIRUS (HCV) Ribavirin
English: Based on the biliary elimination pathway of azithromycin, no drug interactions are expected between azithromycin and INTELENCE.
Croatian: S obzirom na to da se azitromicin eliminira putem žuči, ne očekuje se interakcija azitromicina i lijeka INTELENCE.
English: Based on historical data, a decrease in etravirine exposure may be expected whereas an increase in rifabutin exposure and especially in 25-O-desacetyl-rifabutin may be expected.
Croatian: Na temelju podataka iz prošlosti, može se očekivati smanjenje izloženosti etravirinu, a može se očekivati i povećanje izloženosti rifabutinu a osobito 25-O-dezacetil-rifabutinu.
English: Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Croatian: Bolesnike treba savjetovati da potraže medicinski savjet ako osjete bol u zglobovima, ukočenost zglobova ili teškoće pri kretanju.
English: In mice, the key target organs identified were the liver and the coagulation system.
Croatian: Kod miševa, ključni ciljni organi bili su jetra i koagulacijski sustav.
English: Confidence interval around observed difference of response rates; P-value from CMH test controlling for stratification factors = 0.0199 for de novo, and < 0.0001 for not de novo.
Croatian: Interval pouzdanosti oko opažene razlike u stopama odgovora; P-vrijednost iz CMH testa za kontrolu stratifikacijskih faktora = 0,0199 za de novo i < 0,0001 za ne de novo.
English: Doing so could increase the risk of the virus developing resistance.
Croatian: Prestankom uzimanja možete povećati rizik od razvoja otpornosti virusa na lijek.
English: INTELENCE has minor influence on the ability to drive and use machines.
Croatian: INTELENCE malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: - Stratification: Randomisation was stratified by the intended use of ENF in the BR, previous use of darunavir and screening viral load.
Croatian: - Stratifikacija: Randomizacija je bila stratificirana prema namjeri primjene ENF u BR, prethodnoj primjeni darunavira i probiru virusnog opterećenja.
English: It is not recommended to combine INTELENCE with any of the following medicines: - tipranavir/ritonavir, efavirenz, nevirapine, rilpivirine, indinavir, nelfinavir, atazanavir/cobicistat,
Croatian: Ne preporučuje se kombinirati INTELENCE s bilo kojim od slijedećih lijekova: - tipranavir/ritonavir, efavirenz, nevirapin, rilpivirin, indinavir, nelfinavir, atazanavir/kobicistat,
English: Etravirine is a weak inhibitor of CYP2C9 and CYP2C19.
Croatian: Etravirin je slabi inhibitor CYP2C9 i CYP2C19.
English: In vitro experiments with human liver microsomes (HLMs) indicate that etravirine primarily undergoes oxidative metabolism by the hepatic cytochrome CYP450 (CYP3A) system and, to a lesser extent, by the CYP2C family, followed by glucuronidation.
Croatian: In vitro pokusi s mikrosomima humane jetre pokazuju da etravirin uglavnom prolazi oksidativni metabolizam putem sustava jetenog citokroma CYP450 (CYP3A), a u manjoj mjeri skupina izoenzima CYP2C, nakon čega slijedi glukuronidacija.
English: In a postmarketing retrospective cohort study aiming at substantiating the long-term safety profile of etravirine in HIV-1-infected children and adolescents receiving etravirine with other HIV-1 antiretrovirals (N = 182), Stevens-Johnson Syndrome was reported at a higher incidence (1%) than has been reported in adult clinical trials (<0.1%).
Croatian: U retrospektivnom kohortnom ispitivanju provedenom nakon stavljanja lijeka u promet s ciljem potvrđivanja dugoročnog sigurnosnog profila etravirina u djece i adolescenata zaraženih virusom HIV-1 koji su primali etravirin zajedno s drugim antiretrovirusnim lijekovima za liječenje infekcije virusom HIV-1 (N = 182), prijavljena incidencija Stevens-Johnsonova sindroma (1%) bila je viša od one prijavljene u kliničkim ispitivanjima u odraslih (< 0,1%).
English: No unchanged drug was detected in urine so the impact of renal impairment on etravirine elimination is expected to be minimal.
Croatian: Nije otkriven nepromijenjeni lijek u mokraći, pa se očekuje minimalan utjecaj oštećenja funkcije bubrega na eliminaciju etravirina.
English: The presence of K103N alone, which was the most prevalent NNRTI mutation in DUET-1 and DUET-2 at baseline, was not identified as a mutation associated with resistance to etravirine.
Croatian: Prisutnost samo K103N, koja je na početku ispitivanja DUET-1 i DUET-2 bila NNRTI mutacija s najvećom prevalencijom, nije bila ustanovljena kao mutacija povezana s rezistencijom na etravirin.
English: HMG CO-A REDUCTASE INHIBITORS Atorvastatin
Croatian: INHIBITORI HMG CO-A REDUKTAZE Atorvastatin
English: Population pharmacokinetic analysis in HIV infected patients showed that etravirine pharmacokinetics are not considerably different in the age range (18 to 77 years) evaluated, with 6 subjects aged 65 years or older (see sections 4.2 and 4.4).
Croatian: Populacijska farmakokinetička analiza bolesnika zaraženih HIV-om pokazala je da farmakokinetika etravirina nije znatno različita u ispitivanom rasponu dobi (18 do 77 godina), pri čemu je 6 ispitanika bilo u dobi od 65 godina ili starijih (vidjeti dijelove 4.2 i 4.4).
English: Please refer to the product information of the associated boosted PI for the dose adjustment of rifabutin to be used.
Croatian: Molimo pogledati informacije o povezanim IP-ima za prilagodbu doze rifabutina koja bi se trebala primijeniti.
English: The most frequent (incidence ≥ 10%) adverse reactions of all intensities reported for etravirine were rash, diarrhoea, nausea and headache.
Croatian: Najučestalije nuspojave (incidencija ≥ 10%) na lijek svih intenziteta prijavljenih za etravirin bile su osip, dijareja, mučnina i glavobolja.
English: 800 mg 3 times daily + etravirine 200 mg every 12 hours boceprevir
Croatian: 800 mg 3 puta dnevno + etravirin 200 mg svakih 12 sati boceprevir
English: In women receiving etravirine 200 mg twice daily, higher mean values for Cmax, AUC12h and Cmin were observed during pregnancy compared to postpartum.
Croatian: Kod žena koje su uzimale etravirin 200 mg dva puta dnevno, zabilježene su više srednje vrijednosti Cmax, AUC12h i Cmin tijekom trudnoće u usporedbi s postpartalnim razdobljem.
English: Do not use this medicine after the expiry date which is stated on the carton and on the bottle after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i boci iza oznake „Rok valjanosti“ ili „EXP“.
English: Etravirine efficacy in relation to NNRTI resistance at baseline has mainly been analysed with etravirine given in combination with darunavir/ritonavir (DUET-1 and DUET-2).
Croatian: Djelotvornost etravirina u odnosu na rezistenciju prema NNRTI na početku liječenja bila je uglavnom analizirana kad se etravirin davao u kombinaciji s darunavirom/ritonavirom (DUET-1 i DUET-2).
English: Adverse reactions such as somnolence and vertigo have been reported in etravirine-treated patients and should be considered when assessing a patient's ability to drive or operate machinery (see section 4.8).
Croatian: Nuspojave poput somnolencije i vrtoglavice prijavljene su kod bolesnika liječenih etravirinom i potrebno ih je uzeti u obzir pri procjeni bolesnikove sposobnosti upravljanja vozilima ili rada sa strojevima (vidjeti dio 4.8).
English: Overall de novo ENF
Croatian: Ukupno de novo ENF
English: At week 48, 53.5% of all paediatric patients had a confirmed undetectable viral load < 50 HIV-1 RNA copies/ml according to the TLOVR algorithm.
Croatian: U 48. tjednu, 53,5% od svih pedijatrijskih bolesnika imalo je potvrđeno nemjerljivo virusno opterećenje < 50 HIV-1 RNK kopija/ml prema TLOVR algoritmu.
English: Rash was mostly self-limiting, and generally resolved within 1-2 weeks on continued therapy (see section 4.4).
Croatian: Osip je uglavnom bio samoograničavajući i obično je nestajao u roku od 1-2 tjedna uz kontinuirano liječenje (vidjeti dio 4.4).
English: It is not recommended to co-administer tipranavir/ritonavir and INTELENCE (see section 4.4).
Croatian: Ne preporučuje se istodobno primjenjivati tipranavir/ritonavir i INTELENCE (vidjeti dio 4.4).
English: Itraconazole and ketoconazole are potent inhibitors as well as substrates of CYP3A4.
Croatian: Itrakonazol i ketokonazol su snažni inhibitori a također i supstrati CYP3A4.
English: - Tell your doctor if you develop a rash.
Croatian: - Upozorite svog liječnika ako Vam se razvije osip.
English: The combination of INTELENCE and atorvastatin can be given without any dose adjustments, however, the dose of atorvastatin may need to be altered based on clinical response.
Croatian: INTELENCE se može dati u kombinaciji s atorvastatinom bez ikakve prilagodbe doze, međutim, dozu atorvastatina možda će trebati prilagoditi na temelju kliničkog odgovora.
English: No dose adjustment is suggested but caution is advised in patients with moderate hepatic impairment.
Croatian: Nije predložena prilagodba doze, ali se savjetuje oprez kod bolesnika s umjerenim oštećenjem jetre.
English: Delay in stopping INTELENCE treatment after the onset of severe rash may result in a life-threatening reaction.
Croatian: Odgoda prekida liječenja lijekom INTELENCE nakon pojave teškog osipa može za posljedicu imati po život opasnu reakciju.
English: The combination of INTELENCE with a boosted PI and rifabutin should be used with caution due to the risk of decrease in etravirine exposure and the risk of increase in rifabutin and 25-O-desacetyl-rifabutin exposures.
Croatian: Kombinacija lijeka INTELENCE s pojačanim IP-ima i rifabutinom trebala bi se upotrebljavati s oprezom zbog rizika od smanjenja izlaganja etravirinu i zbog rizika povećanja rifabutina i izloženosti 25-O-desacetilrifabutinu.
English: Your doctor will advise you how to deal with your symptoms and whether INTELENCE must be stopped; - headache; - diarrhoea, nausea.
Croatian: Liječnik će Vam savjetovati kako da postupite u vezi s tim simptomima i morate li prestati uzimati INTELENCE; - glavobolja; - proljev, mučnina.
English: Rifabutin 300 mg once daily
Croatian: Rifabutin 300 mg jedanput dnevno
English: If you belong to this age group, please discuss the use of INTELENCE with your doctor.
Croatian: Ako pripadate toj dobnoj skupini, molimo Vas da zajedno s Vašim liječnikom razmotrite možete li uzimati INTELENCE.
English: Population pharmacokinetic analysis of etravirine in HIV infected patients indicated no apparent difference in the exposure to etravirine between Caucasian, Hispanic and Black subjects.
Croatian: Analiza populacijske farmakokinetike etravirina u bolesnika zaraženih HIV-om nije pokazala vidljive razlike u izloženosti etravirinu između bijelaca, ispitanika latinoameričkog podrijetla i crnaca.
English: INTELENCE tablets contain lactose.
Croatian: INTELENCE tablete sadrže laktozu.
English: The study enrolled patients on a stable but virologically failing antiretroviral treatment regimen, with a confirmed HIV-1 RNA plasma viral load ≥ 500 copies/ml.
Croatian: Ispitivanje je uključilo bolesnike sa stabilnom, ali virološki neuspješnom, antiretrovirusnom shemom liječenja s potvrđenim HIV-1 RNK virusnim opterećenjem u plazmi ≥ 500 kopija/ml.
English: Following virologic failure of an etravirine-containing regimen it is not recommended to treat patients with efavirenz and/or nevirapine.
Croatian: Nakon neuspjelog virološkog odgovora na liječenje koji uključuje etravirin, ne preporučuje se bolesnike liječiti efavirenzom i/ili nevirapinom.
English: Immunologic parameters
Croatian: Imunološki parametri
English: 8 weeks after opening the bottle.
Croatian: 8 tjedana nakon otvaranja boce.
English: Close monitoring for virologic response and for rifabutin related adverse reactions is recommended.
Croatian: Preporučuje se pažljivo motrenje virološkog odgovora i nuspojava vezanih uz rifabutin.
English: The evidence of efficacy of etravirine is based on 48-week data from 2 Phase III trials DUET-1 and DUET-2.
Croatian: Dokaz djelotvornosti etravirina temelji se na podacima dobivenima u 2 ispitivanja faze III, DUET-1 i DUET-2, u trajanju od 48 tjedana.
English: Confidence interval around observed difference of response rates; P-value = 0.0408.
Croatian: Interval pouzdanosti oko opažene razlike u stopama odgovora; P-vrijednost = 0,0408.
English: P-value < 0.0001 for mean decrease in HIV-1 RNA; P-value = 0.0006 for mean change in CD4 cell count.
Croatian: P-vrijednost < 0,0001 za prosječno smanjenje HIV-1 RNK; P-vrijednost = 0,0006 za prosječnu promjenu broja CD4 stanica.
English: C-etravirine showed that < 1.2% of the administered dose of etravirine is excreted in the urine.
Croatian: -etravirinom pokazali su da se < 1,2% primijenjene doze etravirina izluči u mokraći.
English: INTELENCE tablets should be stored in the original bottle and keep the bottle tightly closed in order to protect from moisture.
Croatian: Tablete INTELENCE treba čuvati u originalnoj boci i bocu čuvajte čvrsto zatvorenu radi zaštite od vlage.
English: Rarely, during INTELENCE treatment, you can experience severe skin rash with blisters or peeling skin, particularly around the mouth or eyes or hypersensitivity reaction (allergic reaction including rash and fever but also swelling of the face, tongue or throat, difficulty in breathing or swallowing) which could be potentially life-threatening.
Croatian: Rijetko tijekom liječenja lijekom INTELENCE možete doživjeti težak kožni osip praćen mjehurićima ili ljuštenjem kože, osobito oko usta ili očiju, ili reakciju preosjetljivosti koja potencijalno može biti opasna po život (alergijska reakcija koja uključuje osip i vrućicu, ali i oticanje lica, jezika ili grla, teškoće s disanjem ili gutanjem).
English: Medicinal products that affect etravirine exposure
Croatian: Lijekovi koji utječu na izloženost etravirinu
English: < 400 HIV-1 RNA copies/ml n (%)
Croatian: < 400 HIV-1 RNK kopija/ml n (%)
English: In clinical trials, the frequency, type and severity of adverse reactions in paediatric patients were comparable to those observed in adults.
Croatian: U kliničkim su ispitivanjima učestalost, vrsta i težina nuspojava u pedijatrijskih bolesnika bile usporedive s onima primijećenima u odraslih.