FrancophonIA/ELRC3.0 huggingface dataset:
English: Elvitegravir is a modest inducer and may have the potential to induce CYP2C9 and/or inducible UGT enzymes; as such it may decrease the plasma concentration of substrates of these enzymes.
Croatian: Elvitegravir je umjereni induktor i može imati potencijal indukcije CYP2C9 i/ili inducibilnih enzima UGT; kao takav može smanjiti plazmatske koncentracije supstrata tih enzima.
English: The biotransformation of emtricitabine includes oxidation of the thiol moiety to form the 3'-sulfoxide diastereomers (~ 9% of dose) and conjugation with glucuronic acid to form 2'-O-glucuronide (~ 4% of dose).
Croatian: Biotransformacija emtricitabina uključuje oksidaciju tiolnog dijela molekule pri čemu nastaju 3'-sulfoksid diastereomeri (~9% doze), i konjugaciju s glukuronskom kiselinom, pri čemu nastaje 2'-O-glukuronid (~4% doze).
English: Missing data during window but on study drug a Week 48 window is between Day 309 and 378 (inclusive).
Croatian: Podaci za vremenski okvir nedostaju, ali se ispitivani lijek primjenjuje a Okvir 48. tjedna je između 309. i 378. dana (uključujući).
English: Most patients who developed resistance substitutions to elvitegravir developed resistance substitutions to both emtricitabine and elvitegravir.
Croatian: Većina bolesnika koji su razvili supstitucije rezistencije na elvitegravir razvili su supstitucije rezistencije i na emtricitabin i na elvitegravir.
English: Primary mutations for raltegravir/elvitegravir do not affect the in vitro susceptibility of dolutegravir as single mutations, and the additional presence of secondary mutations (except Q148) also does not result in relevant fold changes in experiments with site directed mutants.
Croatian: Kao pojedinačne mutacije, primarne mutacije za raltegravir/elvitegravir ne utječu na osjetljivost na dolutegravir in vitro, a dodatna prisutnost sekundarnih mutacija (osim Q148) također ne dovodi do relevantnih višestrukih promjena u pokusima s ciljanom mutagenezom.
English: Patients receiving Stribild or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with HIV associated diseases.
Croatian: U bolesnika koji primaju Stribild ili neku drugu antiretrovirusnu terapiju mogu se i dalje razvijati oportunističke infekcije i druge komplikacije infekcije HIV-om, pa bi stoga morali ostati pod strogim kliničkim nadzorom liječnika koji imaju iskustva u liječenju bolesnika s bolestima povezanim s HIV-om.
English: 5 The predominant circulating metabolite of sofosbuvir.
Croatian: 5 Glavni metabolit sofosbuvira u cirkulaciji.
English: No human data on the effect of Stribild on fertility are available.
Croatian: Nema dostupnih podataka o utjecaju Stribilda na plodnost u ljudi.
English: In vitro studies indicate that emtricitabine is not an inhibitor of human CYP450 enzymes.
Croatian: In vitro ispitivanja ukazuju da emtricitabin nije inhibitor ljudskih enzima CYP450.
English: EU/1/13/830/001 30 film-coated tablets EU/1/13/830/002 90 (3 bottles of 30) film-coated tablets
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/830/001 30 filmom obloženih tableta EU/1/13/830/002 90 (3 boce od 30) filmom obloženih tableta
English: The safety and efficacy of Stribild in children under the age of 12 years have not been established (see section 4.2 for information on paediatric use).
Croatian: Sigurnost i djelotvornost Stribilda u djece u dobi do 12 godina nisu ustanovljene (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: If Stribild is stopped for any reason, speak to your doctor before you restart taking Stribild tablets.
Croatian: Ako zbog bilo kojeg razloga prestanete uzimati Stribild, porazgovarajte s liječnikom prije nego što ponovno počnete uzimati tablete Stribilda.
English: acute tubular necrosis1, nephritis (including acute interstitial nephritis)1,5, nephrogenic diabetes insipidus1
Croatian: akutna tubularna nekroza1, nefritis (uključujući akutni intersticijski nefritis)1,5, nefrogeni dijabetes insipidus1
English: Relative to fasting conditions, the administration of Stribild with a light meal (~373 kcal, 20% fat) or high-fat meal (~800 kcal, 50% fat) resulted in increased exposures of elvitegravir and tenofovir.
Croatian: U odnosu na natašte, primjena Stribilda s laganim obrokom (~373 kcal, 20% masnoće) ili visokomasnim obrokom (~800 kcal, 50% masnoće) rezultirala je povećanom izloženošću elvitegraviru i tenofoviru.
English: However, patients should be informed that dizziness, fatigue and insomnia have been reported during treatment with Stribild.
Croatian: Međutim, bolesnike se mora obavijestiti da su zabilježeni omaglica, umor i nesanica tijekom liječenja Stribildom.
English: The Stribild renal educational brochure for prescribers of adolescent patients shall contain the following key safety messages:
Croatian: Edukativna brošura o utjecaju lijeka Stribild na bubrege za one koji propisiju adolescentima, mora sadržavati sljedeće ključne sigurnosne poruke:
English: What you need to know before you take Stribild Do not take Stribild
Croatian: Što morate znati prije nego počnete uzimati Stribild
English: Reduced susceptibility to elvitegravir was most commonly associated with the integrase substitutions T66I, E92Q and Q148R.
Croatian: Smanjena osjetljivost na elvitegravir najčešće je bila povezana sa supstitucijama integraze T66I, E92Q i Q148R.
English: If you accidentally take more than the recommended dose of Stribild you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).
Croatian: Ako slučajno uzmete više od preporučene doze Stribilda, može Vam se povećati rizik od mogućih nuspojava ovog lijeka (pogledajte dio 4, Moguće nuspojave).
English: Eight of the 89 patients (9.0%) discontinued study drug due to renal adverse events.
Croatian: Osam od 89 bolesnika (9,0 %) prekinulo je uzimanje ispitivanog lijeka zbog štetnih događaja povezanih s bubrezima
English: Emtricitabine triphosphate and tenofovir diphosphate competitively inhibit HIV-1 reverse transcriptase, resulting in DNA chain termination.
Croatian: Emtricitabin trifosfat i tenofovirdifosfat kompetitivno inhibiraju HIV-1 reverznu transkriptazu, što rezultira prekidom lanca DNK.
English: 7 Study conducted with emtricitabine/tenofovir disoproxil + darunavir (800 mg) + ritonavir (100 mg).
Croatian: 7 Ispitivanje provedeno s emtricitabinom/tenofovirdizoproksilom + darunavir (800 mg) + ritonavir (100 mg).
English: The laboratory findings in these 4 subjects with evidence of proximal tubulopathy improved without clinical consequence upon discontinuation of Stribild, but did not completely resolve in all subjects.
Croatian: Laboratorijski nalazi u ta 4 ispitanika koji su pokazali proksimalnu tubulopatiju bez kliničkih posljedica, nakon prekida Stribilda su se poboljšali, ali se nisu u potpunosti uklonili u svih ispitanika.
English: Based on drug interaction studies conducted with the components of Stribild, no clinically significant drug interactions have been either observed or are expected between the components of Stribild and the following medicinal products: entecavir, famciclovir, famotidine, omeprazole, ribavirin and sertraline.
Croatian: Na osnovi ispitivanja interakcija lijekova provedenih s komponentama Stribilda nisu zabilježena nikakve klinički značajne interakcije lijekova niti se očekuju između komponenti Stribilda i sljedećih lijekova: entekavira, famciklovira, famotidina, omeprazola, ribavirina i sertralina.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of Stribild in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni Stribilda u trudnica ograničeni (manje od 300 ishoda trudnoća).
English: If you are taking an antacid such as aluminium/magnesium hydroxide or a multivitamin supplement, take it at least 4 hours before or at least 4 hours after Stribild.
Croatian: Ako uzimate antacid, kao što je aluminijev/magnezijev hidroksid, ili multivitaminski dodatak, uzmite ga najmanje 4 sata prije ili najmanje 4 sata nakon uzimanja Stribilda.
English: Start with the lowest possible dose of atorvastatin with careful monitoring upon co-administration with Stribild.
Croatian: Potrebno je započeti s najnižom mogućom dozom atorvastatina uz pažljivo praćenje nakon istodobne primjene s lijekom
English: The median terminal plasma half-life of elvitegravir following administration of Stribild is approximately 12.9 hours.
Croatian: Medijan poluvremena elvitegravira u plazmi nakon primjene Stribilda iznosi oko 12,9 sati.
English: Moreover, at concentrations substantially higher (approximately 300-fold) than those observed in vivo, tenofovir did not inhibit in vitro drug metabolism mediated by any of the major human CYP450 isoforms involved in drug biotransformation (CYP3A4, CYP2D6, CYP2C9, CYP2E1, or CYP1A1/2).
Croatian: Štoviše, pri koncentracijama značajno većim (oko 300 puta većim) od onih zapaženih in vivo, tenofovir nije inhibirao in vitro metabolizam lijekova posredovan bilo kojim od glavnih humanih izoobolika CYP450 uključenih u biotransformaciju lijekova (CYP3A4, CYP2D6, CYP2C9, CYP2E1 ili CYP1A1/2).
English: Some patients taking combination antiretroviral medicines such as Stribild may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Croatian: Neki bolesnici koji uzimaju kombinirane antiretrovirusne lijekove kao što je Stribild mogu razviti bolest kostiju koja se zove osteonekroza (odumiranje koštanog tkiva prouzrokovano gubitkom prokrvljenosti kosti).
English: Due to limitations of the study, a benefit of tenofovir disoproxil over placebo was not demonstrated based on plasma HIV-1 RNA levels at week 24.
Croatian: Zbog ograničenja kliničkog ispitivanja nije se pokazala korist tenofovirdizoproksila u usporedbi s placebom na temelju razina HIV-1 RNK u plazmi u 24. tjednu.
English: Recommended dose for adults and adolescents aged 12 to less than 18 years who weigh at least 35 kg:
Croatian: Preporučena doza za odrasle i adolescente u dobi od 12 do 18 godina, tjelesne težine od najmanje 35 kg:
English: As elvitegravir and cobicistat are highly bound to plasma proteins it is unlikely that elvitegravir and cobicistat will be significantly removed by haemodialysis or peritoneal dialysis.
Croatian: Budući da su elvitegravir i kobicistat u visokom postotku vezani za proteine plazme, nije vjerojatno da će se elvitegravir i kobicistat značajno ukloniti hemodijalizom ili peritonejskom dijalizom.
English: There is no specific antidote for overdose with Stribild.
Croatian: Ne postoji specifični antidot za predoziranje Stribildom.
English: elevated creatine kinase1
Croatian: povišena kreatin kinaza1
English: Stribild is not recommended in this population (see section 4.2).
Croatian: Ne preporučuje se primjena Stribilda u ovoj populaciji (vidjeti dio 4.2).
English:  If any of these applies to you, you should not take Stribild and you should tell your doctor immediately.
Croatian: Ako se bilo što od ovoga odnosi na Vas, ne smijete uzimati Stribild i morate odmah o tome obavijestiti liječnika.
English: Patients co-infected with HIV and HBV who discontinue Stribild should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment.
Croatian: Bolesnike istodobno inficirane HIV-om i HBV-om koji prekinu liječenje Stribildom mora se pažljivo pratiti uz kliničku i laboratorijsku kontrolu tijekom najmanje nekoliko mjeseci nakon prekida liječenja.
English: Virologic response was defined as achieving an undetectable viral load (< 50 HIV-1 RNA copies/mL, snapshot analysis).
Croatian: Virološki odgovor definiran je kao postizanje nemjerljivog virusnog opterećenja (< 50 HIV-1 RNK kopije/ml, analiza snimaka).
English: Renal and bone effects in the paediatric population
Croatian: Učinci na funkciju bubrega i kosti u pedijatrijskoj populaciji
English: Therefore, Stribild should not be co-administered with medicinal products that include, but are not limited to, the following (see section 4.5):
Croatian: Stoga se Stribild ne smije primjenjivati istodobno s lijekovima koji uključuju, ali nisu ograničeni na sljedeće lijekove (vidjeti dio 4.5):
English: Mean age was 15 years (range, 12−17), 70% were male, 68% black, 28% Asian.
Croatian: Srednja dob ispitanika bila je 15 godina (raspon, 12-17), gdje je 70% ispitanika bilo muškog spola, 68% bili su crnci/afroamerikanci i 28% azijati.
English: In infants and children older than 4 months, the majority of patients taking emtricitabine achieved or maintained complete suppression of plasma HIV-1 RNA through 48 weeks (89% achieved ≤ 400 copies/ml and 77% achieved ≤ 50 copies/ml).
Croatian: U novorođenčadi i djece starije od 4 mjeseca, u većine bolesnika liječene emtricitabinom postignuta je ili održana potpuna supresija HIV-1 RNK u plazmi tijekom 48 tjedana (89% je postiglo ≤ 400 kopija/ml i 77% je postiglo ≤ 50 kopija/ml).
English: That a multidisciplinary approach is recommended for the management of adolescent patients.
Croatian: Da se preporučuje višedisciplinarni pristup liječenju adolescentnih bolesnika.
English: It is recommended that Stribild is not initiated in patients with creatinine clearance < 90 mL/min unless, after review of the available treatment options, it is considered that Stribild is the preferred treatment for the individual patient.
Croatian: Preporučuje se da se liječenje Stribildom ne započinje u bolesnika s klirensom kreatinina < 90 ml/min, osim ako se nakon pregleda dostupnih mogućnosti liječenja ne smatra da je Stribild preferirano liječenje za pojedinog bolesnika.
English: Twenty patients from these studies who switched to Stribild had the NNRTI-associated K103N substitution in their historical genotype prior to starting initial antiretroviral therapy.
Croatian: Dvadeset bolesnika iz ovih ispitivanja koji su prešli na Stribild imalo je supstituciju K103N povezanu s NNRTI prisutnu u genotipu prije započinjanja prve antiretrovirusne terapije.
English: However, a large amount of data in pregnant women (more than1,000 pregnancy outcomes) indicate no malformations or foetal/neonatal toxicity associated with emtricitabine and tenofovir disoproxil.
Croatian: Međutim, opsežni podaci (više od 1000 ishoda trudnoća) ne ukazuju na postojanje malformacija i feto/neonatalno toksičnog učinka povezanog s emtricitabinom i tenofovirdizoproksilom.
English: Elderly patients are more likely to have decreased renal function, therefore caution should be exercised when treating elderly patients with Stribild.
Croatian: U starijih bolesnika je veća vjerojatnost da imaju smanjenu funkciju bubrega, pa se stoga mora primijeniti oprez kad se stariji bolesnici liječe Stribildom.
English: The safety and efficacy of Stribild in children under the age of 12 years or weighing < 35 kg have not been established (see section 5.2).
Croatian: Sigurnost i djelotvornost Stribilda u djece u dobi do 12 godina ili tjelesne težine < 35 kg nisu ustanovljene (vidjeti dio 5.2).
English: If you are a woman with HIV it is recommended that you do not breast-feed to avoid passing the virus to the baby in breast milk.
Croatian: Ako ste žena zaražena virusom HIV-a, preporučuje se da ne dojite kako bi se izbjegla mogućnost da virus u majčinom mlijeku prijeđe na dojenče.
English: For information on other acid reducing agents (e.g. H2-receptor antagonists and proton pump inhibitors), see Studies conducted with other medicinal products.
Croatian: Informacije o drugim lijekovima koji reduciraju kiselinu (npr. antagonisti H2-receptora i inhibitori protonske pumpe) možete pronaći u dijelu „Ispitivanja provedena s drugim lijekovima”.
English: increased transaminases1, hyperbilirubinaemia1
Croatian: povišene transaminaze1, hiperbilirubinemija
English: • yellow skin or eyes, itching, or pain in the abdomen (tummy) caused by inflammation of the liver (hepatitis)
Croatian: • žutilo kože ili očiju, svrbež ili bolovi u trbuhu uzrokovani upalom jetre (hepatitis)
English: c Includes subjects who had ≥ 50 copies/mL in the Week 48 or Week 144 window, subjects who discontinued early due to lack or loss of efficacy, subjects who discontinued for reasons other than an adverse event, death or lack or loss of efficacy and at the time of discontinuation had a viral value of ≥ 50 copies/mL.
Croatian: c Obuhvaća ispitanike koji su imali ≥ 50 kopija/ml u okviru 48. tjedna ili 144. tjedna, ispitanike s ranim prekidom zbog nedostatka ili gubitka djelotvornosti, ispitanike koji su prekinuli iz razloga koji nisu posljedica nuspojave, smrti ili nedostatka ili gubitka djelotvornosti i koji su u vrijeme prekida imali virusnu vrijednost ≥ 50 kopija/ml.
English: Therefore, information regarding drug-drug interactions with other antiretroviral products (including protease inhibitors and non-nucleoside reverse transcriptase inhibitors) is not provided (see section 4.4).
Croatian: Stoga, nisu navedene informacije o interakcijama lijekova s drugim antiretrovirusnim lijekovima (kao ni s inhibitorima proteaze i nukleozidnim inhibitorima reverzne transkriptaze) (vidjeti dio 4.4).
English: When administering with Stribild, the maximum daily dose of itraconazole should not exceed 200 mg per day.
Croatian: Prilikom primjene sa Stribildom maksimalna dnevna doza itrakonazola ne smije biti veća od 200 mg na dan.
English: There are uncertainties associated with the long-term effects of tenofovir disoproxil bone and renal toxicity.
Croatian: Postoje nesigurnosti povezane s dugoročnim učincima tenofovirdizoproksila na toksičnost za kosti i bubrege.
English: Stribild is indicated for use as a complete regimen for the treatment of HIV-1 infection and must not be administered with other antiretroviral products.
Croatian: Stribild je indiciran za primjenu kao potpuni režim liječenja infekcije HIV-1 i ne smije se primjenjivati s drugim antiretrovirusnim lijekovima.
English: Due to protocol violation, two patients with historical K103N substitutions discontinued early with HIV-1 RNA < 50 copies/mL.
Croatian: Zbog kršenja protokola, dva bolesnika sa prethodnom supstitucijom K103N prekinula su terapiju ranije s HIV-1 RNK < 50 kopija/ml.
English: Of these discontinuations, 7 in the Stribild group and 1 in the ATV/r+FTC/tenofovir disoproxil group occurred during the first 48 weeks.
Croatian: Od tih prekida, 7 prekida u skupini koja je primala Stribild i 1 prekid u skupini ATV/r+ FTC/tenofovirdizoproksildogodili su se tijekom prvih 48 tjedana.
English: Exposures of cobicistat and emtricitabine in paediatric patients aged 12 to <18 years were similar to exposures achieved in adults.
Croatian: Izloženosti kobicistatu i emtricitabinu u pedijatrijskih bolesnika u dobi od 12 do 18 godina bile su slične izloženostima u odraslih bolesnika.
English: Before initiating treatment with Stribild
Croatian: Prije početka liječenja Stribildom
English: Eighteen of these 20 patients maintained virologic suppression through 48 weeks.
Croatian: U 18 od tih 20 bolesnika virus je ostao suprimiran tijekom 48 tjedana.
English: • and you notice 18 hours or more after the time you usually take Stribild, then do not take the missed dose.
Croatian: • i primijetite to kada je prošlo 18 sati ili više od vremena kada obično uzimate Stribild, propuštenu dozu nemojte uzeti.
English: When administering with Stribild, the maximum daily dose of ketoconazole should not exceed 200 mg per day.
Croatian: Prilikom primjene sa Stribildom maksimalna dnevna doza ketokonazola ne smije biti veća od 200 mg na dan.
English: No data are available on which to make a dose recommendation for patients over the age of 65 years (see sections 4.4 and 5.1).
Croatian: Nema dostupnih podataka na osnovi kojih bi se mogla preporučiti doza za bolesnike starije od 65 godina (vidjeti dijelove 4.4 i 5.1).
English: • Children commonly experienced low red blood cell count (anaemia).
Croatian: • U djece je često zabilježen nizak broj crvenih krvnih stanica (anemija)
English: Patients who failed treatment with Stribild and who had HIV-1 with emergent Stribild resistance substitutions harboured virus that remained susceptible to all PIs, NNRTIs, and most other NRTIs.
Croatian: Bolesnici u kojih liječenje Stribildom nije bilo uspješno i koji imaju HIV-1 s novonoastalim supstitucijama rezistencije na Stribild, sadrže virus koji je ostao osjetljiv na sve PI-ove, NNRTI-ove i većinu drugih NRTI-ova.
English: Voxilaprevir (400 mg/100 mg/ 100 mg+100 mg once daily)6 +
Croatian: voksilaprevir (400 mg/100 mg/ 100 mg+100 mg jedanput na dan)6
English: Following oral administration of Stribild with food in HIV-1 infected subjects, peak plasma concentrations were observed 4 hours post-dose for elvitegravir, 3 hours post-dose for cobicistat, 3 hours post-dose for emtricitabine, and 2 hours for tenofovir following the rapid conversion of tenofovir disoproxil.
Croatian: Nakon peroralne primjene Stribilda s hranom u bolesnika zaraženih virusom HIV-1, vršne vrijednosti koncentracije u plazmi zapažene su 4 sata nakon doziranja elvitegravira, 3 sata nakon doziranja kobicistata, 3 sata nakon doziranja emtricitabina i 2 sata za tenofovir nakon brze konverzije tenofovirdizoproksila.
English: Exposures of elvitegravir and tenofovir in paediatric patients aged 12 to <18 years who received Stribild in GS-US-236-0112 were increased by 30% and 37% respectively, when compared with historical adult controls.
Croatian: Izloženost elvitegraviru i tenofoviru u pedijatrijskih bolesnika u dobi od 12 do 18 godina koji su primali Stribild u ispitivanju GS-US-236-0112, povećala se za 30% odnosno 37% u usporedbi s povijesnom kontrolom u odraslih.
English: While you are taking Stribild
Croatian: Dok uzimate Stribild
English: Moreover, the reversibility of renal toxicity cannot be fully ascertained.
Croatian: Osim toga, nije moguće u potpunosti utvrditi reverzibilnost toksičnosti bubrega.
English: Midazolam and triazolam are primarily metabolised by CYP3A.
Croatian: Midazolam i triazolam prvenstveno se metaboliziraju CYP3A.
English: The effects of tenofovir disoproxil-associated changes in BMD on long-term bone health and future fracture risk are currently unknown (see section 5.1).
Croatian: Učinci promjene BMD-a prouzročene tenofovirdizoproksilom na dugoročno zdravlje kostiju i rizik od prijeloma u budućnosti trenutačno nisu poznati (vidjeti dio 5.1)
English: The dual-drug combinations and the triple combination of elvitegravir, emtricitabine and tenofovir demonstrated synergistic activity in cell culture.
Croatian: Kombinacije dvaju lijekova i trojna kombinacija elvitegravira, emtricitabina i tenofira pokazuju sinergističko djelovanje u staničnoj kulturi.
English: • passing a lot of urine and feeling thirsty (nephrogenic diabetes insipidus)
Croatian: • mokrenje velikih količina mokraće i osjećaj žeđi (nefrogeni dijabetes insipidus)
English: Therefore Stribild should not be used during breast-feeding.
Croatian: Stoga se Stribild ne smije primjenjivati tijekom dojenja.
English: Do not use this medicine after the expiry date which is stated on the bottle and carton after {EXP}.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na boci i kutiji iza „Rok valjanosti”.
English: Following oral administration of boosted [14C]elvitegravir, elvitegravir was the predominant species in plasma, representing ~94% of the circulating radioactivity.
Croatian: Nakon peroralne primjene pojačanog [14C]elvitegravira, elvitegravir je bio prevladavajuća vrsta u plazmi, predstavljajući ~94% cirkulirajuće radioaktivnosti.
English: In vitro binding of emtricitabine to human plasma proteins was < 4% and independent of concentration over the range of 0.02 to 200 µg/mL.
Croatian: In vitro vezanje emtricitabina za humane proteine plazme bilo je < 4% i nije ovisilo o koncentraciji u rasponu od 0,02 do 200 µg/ml.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama u pogledu reproduktivne toksičnosti ne ukazuju na izravne ili neizravne štetne učinke (vidjeti dio 5.3).