FrancophonIA/ELRC3.0 huggingface dataset:
English: Dosage recommendation for paediatric patients older than 6 months to less than 18 years Without Concomitant Efavirenz or Nevirapine
Croatian: Preporuke za doziranje u pedijatrijskih bolesnika starijih od 6 mjeseci i mlađih od 18 godina Bez istodobne primjene efavirenza ili nevirapina
English: • Kaletra is prescribed for use in combination with other antiviral medicines.
Croatian: • Kaletra se koristi u kombinaciji s drugim antivirusnim lijekovima.
English: • severe or life threatening skin rashes and blisters (Stevens-Johnson syndrome and erythema multiforme).
Croatian: • teški ili po život opasni osipi i mjehurići na koži (Stevens-Johnsonov sindrom i erythema multiforme).
English: Outcomes at Week 24: Study P1030 Age: ≥ 14 days and < 6 weeks (N=10)
Croatian: Rezultati u 24. tjednu: studija P1030 Dob: ≥ 14 dana i < 6 tjedana (N=10)
English: Effects on drug levels Geometric Mean Change (%) in AUC, Cmax, Cmin
Croatian: Geometrijska srednja vrijednost promjene (%) u AUC, Cmax, Cmin
English: This is similar to an adult drinking 4-22 ml of beer or 1-4 ml of wine.
Croatian: Ta je koncentracija slična onoj nakon što odrasla osoba popije 4 - 22 ml piva ili 1 - 4 ml vina.
English: They may modify or increase the effect of other medicines.
Croatian: Mogu promijeniti ili pojačati djelovanje drugih lijekova.
English: • No dose adjustment is required for lopinavir/ritonavir during pregnancy and postpartum.
Croatian: • Nije potrebna prilagodba doze lopinavira/ritonavira tijekom trudnoće i poslijeporođajnog razdoblja.
English: Dose adjustment has not been evaluated in clinical practice.
Croatian: Prilagođavanje doze nije ispitano u kliničkoj praksi.
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
Croatian: Ako bilo koja od ovih nuspojava postane ozbiljna ili ako primijetite bilo koju nuspojavu koja nije navedena u ovoj uputi o lijeku, potrebno je obavijestiti liječnika ili ljekarnika.
English: • It is recommended that HIV-infected women do not breast-feed their infants because there is a possibility that the baby can be infected with HIV through your breast milk.
Croatian: • Ne preporučuje se HIV pozitivnim ženama da doje jer postoji mogućnost zaraze djeteta HIV-om putem majčinog mlijeka.
English: • If you are currently using an oral contraceptive or using a patch contraceptive to prevent pregnancy, you should use an additional or different type of contraception (e.g. condom) as Kaletra may reduce the effectiveness of oral and patch contraceptives.
Croatian: • Ukoliko koristite oralne ili flaster kontraceptive za prevenciju trudnoće, morali biste koristiti i dodatnu kontracepciju ili drugi oblik kontracepcije (npr. kondom) jer Kaletra može smanjiti učinkovitost oralnih i flaster kontraceptiva.
English: The clinical relevance of these preclinical data is unknown, however, the potential cardiac effects of this product in humans cannot be ruled out (see also sections 4.4 and 4.8).
Croatian: Klinički značaj tih pretkliničkih podataka nije poznat, no ne mogu se isključiti mogući kardijalni učinci ovog lijeka u čovjeka (vidjeti također dijelove 4.4 i 4.8).
English: Plasma concentrations ↑
Croatian: Plazmatske koncentracije ↑
English: All interaction studies, when otherwise not stated, were performed using Kaletra capsules, which gives an approximately 20% lower exposure of lopinavir than the 200/50 mg tablets.
Croatian: Sve studije interakcija lijeka Kaletra, ukoliko nije drugačije naznačeno, provedene su koristeći Kaletra kapsule, koje pružaju za oko 20% manju izloženost lopinaviru nego 200/50 mg tablete.
English: Serum cholesterol was elevated in rodents but not dogs, while triglycerides were elevated only in mice.
Croatian: Razina serumskog kolesterola bila je povišena u glodavaca, no ne i u pasa, dok je razina triglicerida bila povišena samo u miševa.
English: Animal studies have shown no effects on fertility.
Croatian: Ispitivanja na životinjama pokazala su da nema učinka na plodnost.
English: Check with your pharmacist that you have the correct size of syringe.
Croatian: Provjerite sa svojim ljekarnikom imate li štrcaljku odgovarajućeg volumena.
English: The increased digoxin level may lessen over time as P-gp induction develops.
Croatian: Povećana razina digoksina može se s vremenom smanjiti kako se razvija indukcija P-gp-a.
English: Patients should be closely monitored for signs related to venetoclax toxicities.
Croatian: Bolesnike treba pažljivo nadzirati zbog mogućih znakova povezanih s toksičnošću venetoklaksa.
English: • Your doctor has prescribed Kaletra to help to control your Human Immunodeficiency Virus (HIV) infection.
Croatian: • Liječnik Vam je propisao lijek Kaletra kako bi Vam pomogla u kontroli infekcije virusom humane imunodeficijencije (HIV; engl.
English: The mechanism of this interaction may result from inhibition of transport proteins.
Croatian: Mehanizam te interakcije mogla bi objasniti inhibicija transportnih proteina.
English: Virologic Response of Study Subjects at Week 48 and Week 96 Week 48
Croatian: Virološki odgovor ispitanika u 48. i 96. tjednu 48.tjedan
English: Tell your doctor if you or your child experience
Croatian: Kažite svom liječniku ako Vi ili Vaše dijete iskusite
English: The mean (SD) for the studies are reported in the table below.
Croatian: Srednje vrijednosti (SD) u tim ispitivanjima navedene su u sljedećoj tablici.
English: The CHER study was a randomized, open-label study comparing 3 treatment strategies (deferred treatment, early treatment for 40 weeks, or early treatment for 96 weeks) in children with perinatally acquired HIV-1 infection.
Croatian: Ispitivanje CHER bilo je randomizirano, otvoreno ispitivanje u kojem su se uspoređivale tri terapijske strategije (odgođeno liječenje, rano liječenje tijekom 40 tjedana ili rano liječenje tijekom 96 tjedana) u djece perinatalno zaražene virusom HIV-1.
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer to the relevant product information for these medicinal products.
Croatian: U slučaju istodobne antivirusne terapije za hepatitis B ili C, valja pogledati odgovarajuće upute o uporabi tih lijekova.
English: • This medicinal product does not require any special storage conditions.
Croatian: • Ovaj lijek ne zahtijeva posebne uvjete čuvanja.
English: Because Kaletra oral solution contains alcohol, it is not recommended for use with polyurethane feeding tubes due to potential incompatibility.
Croatian: Budući da Kaletra oralna otopina sadrži alkohol, ne preporučuje se za primjenu putem poliuretanskih sondi za hranjenje zbog moguće inkompatibilnosti.
English: It is advised to write the date of removal from the refrigerator on the package.
Croatian: Preporučuje se na pakiranju napisati datum kada je lijek izvađen iz hladnjaka.
English: Do not take Kaletra with any of the following medicines:
Croatian: Nemojte uzimati lijek Kaletra ako uzimate neke od sljedećih lijekova:
English: Due to induction of lamotrigine glucuronidation
Croatian: Zbog indukcije glukuronidacije lamotrigina
English: Haemophiliac patients should therefore be made aware of the possibility of increased bleeding.
Croatian: Stoga se bolesnike s hemofilijom mora obavijestiti da postoji mogućnost pojačanog krvarenja.
English: For adults and children weighing greater than 15 kg.
Croatian: Za odrasle i djecu tjelesne težine veće od 15 kg.
English: Patients should be monitored closely for a decreased VPA effect when Kaletra and valproic acid or valproate are given concomitantly.
Croatian: Bolesnike treba pomno pratiti zbog smanjenja učinka VPA kada se istodobno primjenjuju Kaletra i valproična kiselina ili valproat.
English: • If you realise you have taken more Kaletra than you were supposed to, contact your doctor right away.
Croatian: • Ako shvatite da ste uzeli više lijeka nego što ste trebali, odmah obavijestite svog liječnika.
English: Therefore, it is reasonable to expect that cardiac lopinavir levels would not be significantly higher than plasma levels.
Croatian: Stoga ima razloga očekivati da razine lopinavira u srcu neće biti znatno više od onih u plazmi.
English: Hypersensitivity to the active substances or to any of the excipients.
Croatian: Preosjetljivost na djelatne tvari ili neku od pomoćnih tvari.
English: Use in children
Croatian: Primjena u djece
English: Mean (%CV) Steady-State Pharmacokinetic Parameters of Lopinavir in HIV-Infected Pregnant Women
Croatian: Srednja vrijednost (%CV) farmakokinetičkih parametara lopinavira u stanju dinamičke ravnoteže u trudnica s HIV infekcijom
English: BSA (m2) = √ (Height (cm) X Weight (kg) / 3600)
Croatian: PT (m2) = √ (visina (cm) X težina (kg) / 3600)
English: Tissue distribution studies conducted in the rat did not suggest significant cardiac retention of the active substance; 72-hour AUC in heart was approximately 50% of measured plasma AUC.
Croatian: Ispitivanja distribucije u tkivima, provedena u štakora, nisu uputila na znatnije zadržavanje lijeka u srcu; AUC u srcu nakon 72 sata bio je otprilike 50 % od AUC-a izmjerenog u plazmi.
English: Do not shake the bottle - this is because air bubbles can form which will affect how well you can measure the dose.
Croatian: Nemojte tresti bocu jer tako mogu nastati mjehurići zraka koji će otežati precizno odmjeravanje doze.
English: It is unknown whether the combination of Kaletra causes a similar increase in trazodone exposure.
Croatian: Nije poznato uzrokuje li Kaletra sličan porast izloženosti trazodonu.
English: EU/1/01/172/005 - multipack: 120 (3 packs of 40) film-coated tablets EU/1/01/172/008 - carton of 120 film-coated tablets
Croatian: EU/1/01/172/005 - višestruko pakiranje: 120 (3 pakiranja od 40) filmom obloženih tableta EU/1/01/172/008 - kutija sa 120 filmom obloženih tableta
English: • Taking Kaletra as recommended should give you the best chance of delaying the development of resistance to the product.
Croatian: • Uzimanje lijeka Kaletra sukladno preporukama daje najveće šanse za odgađanjem razvoja otpornosti na lijek.
English: Kaletra contains 42% v/v alcohol.
Croatian: Kaletra sadrži 42% V/V alkohola.
English: Lamotrigine and Valproate
Croatian: Lamotrigin i valproat
English: Like all medicines, Kaletra can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, Kaletra može izazvati nuspojave, iako se one neće javiti kod svakoga.
English: Other medicines and Kaletra);
Croatian: Drugi lijekovi i Kaletra);
English: These medicinal products include:
Croatian: Ti lijekovi uključuju:
English: − Keep this leaflet.
Croatian: - Sačuvajte ovu uputu.
English: • Keep this medicine out of the sight and reach of children.
Croatian: • Lijek čuvajte izvan pogleda i dohvata djece.
English: Events noted as having frequency “Not known” were identified via post-marketing surveillance.
Croatian: “Nepoznato” su zabilježeni u postmarketinškom praćenju.
English: Ergot alkaloids
Croatian: Ergot alkaloidi
English: • Once-daily administration of lopinavir/ritonavir is not recommended for pregnant women due to the lack of pharmacokinetic and clinical data.
Croatian: • Kod trudnica se primjena lopinavira/ritonavira jednom dnevno ne preporučuje zbog nedostatka farmakokinetičkih i kliničkih podataka.
English: Alcohol and propylene glycol are potentially harmful for those suffering from liver disease, kidney disease, alcoholism, epilepsy, brain injury or disease, as well as for pregnant women and children.
Croatian: Alkohol i propilenglikol su potencijalno štetni za osobe s bolestima jetre, bolestima bubrega, alkoholizmom, epilepsijom, ozljedama i bolestima mozga, kao i za trudnice i djecu.
English: Lack of resistance to lopinavir was confirmed by phenotypic analysis.
Croatian: Nepostojanje rezistencije na lopinavir je potvrđeno fenotipskom analizom.
English: • Muscle pain, tenderness or weakness, particularly in combination with these medicines.
Croatian: • Mišićnu bol, osjetljivost ili slabost, osobito prilikom uzimanja ovih lijekova.
English: For volumes greater than 2 ml.
Croatian: Za volumene veće od 2 ml.
English: Tell your doctor if you or your child have/had
Croatian: Kažite svome liječniku ako ste Vi ili Vaše dijete imali/imate
English: Lopinavir/ritonavir has been shown to cause modest asymptomatic prolongation of the PR interval in some healthy adult subjects.
Croatian: Pokazalo se da lopinavir/ritonavir uzrokuje umjerenu asimptomatsku prolongaciju PR intervala u nekih zdravih odraslih osoba.
English: Healthcare professionals should be aware that Kaletra oral solution is highly concentrated and contains 42.4% alcohol (v/v) and 15.3% propylene glycol (w/v).
Croatian: Zdravstveni radnici moraju biti svjesni da je Kaletra oralna otopina visoko koncentrirana i da sadrži 42,4% alkohola (V/V) i 15,3% propilenglikola (m/V).
English: At steady state, lopinavir is approximately 98 − 99% bound to serum proteins.
Croatian: U stanju dinamičke ravnoteže, oko 98 - 99% lopinavira vezano je na serumske proteine.
English: Uncommon Weight increased, increased appetite
Croatian: Manje često Povećanje tjelesne težine, povećanje apetita
English: *Body surface area can be calculated with the following equation
Croatian: *Površina tijela može se izračunati sljedećom formulom
English: See further the detailed description of the clinical studies.
Croatian: Vidjeti detaljan opis kliničkih ispitivanja u nastavku.
English: • decreased ability of the body to handle sugar including diabetes mellitus, weight loss;
Croatian: • smanjena sposobnost tijela da regulira šećer uključujući šećernu bolest (diabetes mellitus), gubitak tjelesne težine;
English: • yellowing of the skin or whites of eyes (jaundice);
Croatian: • žutilo kože ili bjeloočnica (žutica);
English: Fournier Laboratories Ireland Limited, Carrigtwohill Business Park, Anngrove, Carrigtwohill, Co. Cork, Ireland
Croatian: Fournier Laboratories Ireland Limited, Carrigtwohill Business Park, Anngrove, Carrigtwohill, Co.
English: 60 ml oral solution
Croatian: 60 ml oralne otopine
English: Do not drive a car or operate machinery if you experience any side effects (e.g. nausea) that impact your ability to do so safely.
Croatian: Ne vozite i ne upravljate strojem ukoliko primijetite bilo koju nuspojavu (npr. mučninu) koja može utjecati na Vašu sposobnost sigurne vožnje vozila ili upravljanje strojem.
English: Kaletra pharmacokinetics have not been studied in older people.
Croatian: Farmakokinetika lijeka Kaletra u starijih ljudi nije ispitana.
English: Anxiety Uncommon Abnormal dreams, libido decreased
Croatian: Neuobičajeni snovi, smanjeni libido
English: There is no specific antidote for overdose with Kaletra.
Croatian: Nema specifičnog antidota za predoziranje lijekom Kaletra.
English: Since these patients had not previously been exposed to either Kaletra or efavirenz, part of the response may be attributed to the antiviral activity of efavirenz, particularly in patients harbouring highly lopinavir resistant virus.
Croatian: Budući da bolesnici dotad nisu primali ni lijek Kaletra ni efavirenz, odgovor se djelomice može pripisati i protuvirusnoj aktivnosti efavirenza, osobito u bolesnika zaraženih virusom izrazito rezistentnim na lopinavir.
English: Within this panel, the following mutations in HIV protease were associated with reduced in vitro susceptibility to lopinavir: L10F/I/R/V, K20M/R, L24I, M46I/L, F53L, I54L/T/V, L63P, A71I/L/T/V, V82A/F/T, I84V and L90M.
Croatian: U tom rasponu virusnih izolata sljedeće su mutacije HIV proteaze bile povezane sa smanjenom osjetljivošću na lopinavir in vitro: L10F/I/R/V, K20M/R, L24I, M46I/L, F53L, I54L/T/V, L63P, A71I/L/T/V, V82A/F/T, I84V i L90M.
English: See section 4.4 and section 4.5 for co-administration of sildenafil in patients with erectile dysfunction.
Croatian: Vidjeti dijelove 4.4 i 4.5 za istodobnu primjenu sildenafila kod bolesnika s erektilnom disfunkcijom.
English: BSA (m2) = √ (Height (cm) X Weight (kg) / 3600) It is recommended that Kaletra not be administered in combination with efavirenz or nevirapine in patients less than 6 months of age.
Croatian: PT (m2) = √ (visina (cm) X težina (kg) / 3600) Preporučuje se da se Kaletra ne primjenjuje u kombinaciji s efavirenzom ili nevirapinom u bolesnika mlađih od 6 mjeseci.
English: Outcomes at Week 24: Study P1060 Cohort I
Croatian: Rezultati u 24. tjednu: studija P1060 Kohorta
English: In vitro experiments with human hepatic microsomes indicate that lopinavir primarily undergoes oxidative metabolism.
Croatian: In vitro pokusi s ljudskim mikrosomima iz jetre pokazuju da se lopinavir metabolizira prvenstveno oksidacijskim metabolizmom.
English: • sedatives (e.g. midazolam administered by injection);
Croatian: • sedativi (npr. midazolam primijenjen putem injekcije);
English: • anti-tuberculosis medicine (bedaquiline, delamanid);
Croatian: • lijek za liječenje tuberkuloze (bedakilin, delamanid);
English: Kaletra contains polyoxyl 40 hydrogenated castor oil.
Croatian: Kaletra sadrži polioksil 40 hidrogenirano ricinusovo ulje.
English: High doses of ketoconazole and itraconazole (> 200 mg/day) are not recommended.
Croatian: Ne preporučuju se velike doze ketokonazola ni itrakonazola (> 200 mg/dan).
English: *Proportion of subjects who had HIV-1 < 400 copies/ml and had remained on study treatment
Croatian: *udio ispitanika kojima je razina HIV-1 iznosila < 400 kopija/ml i koji su nastavili primati ispitivano liječenje
English: CYP3A4 inhibitors increase the exposure of lomitapide, with strong inhibitors increasing exposure approximately 27-fold.
Croatian: Inhibitori CYP3A4 povećavaju izloženost lomitapidu, s tim da snažni inhibitori povećavaju izloženost približno 27 puta.
English: Due to the risk of bedaquiline related adverse events, the combination of bedaquiline and Kaletra should be avoided.
Croatian: Zbog rizika od štetnih događaja povezanih s bedakilinom, kombinacija bedakilina i lijeka Kaletra se mora izbjegavati.
English: For caution on parenterally administered midazolam, see section 4.5.
Croatian: Za oprez pri parenteralnoj primjeni midazolama vidjeti dio 4.5.
English: Based on known metabolic profiles, clinically significant interactions are not expected between Kaletra and dapsone, trimethoprim/sulfamethoxazole, azithromycin or fluconazole.
Croatian: Na temelju saznanja o metaboličkim profilima, ne očekuju se klinički značajne interakcije između lijeka Kaletra i dapsona, trimetoprima/sulfametoksazola, azitromicina ili flukonazola.
English: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Croatian: KG, Knollstrasse, 67061 Ludwigshafen, Njemačka Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet:
English: Based on weight (mg/kg)
Croatian: Na temelju težine (mg/kg)
English: Fluvastatin or Pravastatin
Croatian: Fluvastatin ili pravastatin
English: Uncommon Cerebrovascular accident, convulsion, dysgeusia, ageusia, tremor
Croatian: Manje često Cerebrovaskularni incident, konvulzije, disgeuzija, ageuzija, tremor
English: Rifabutin, 150 mg QD Rifabutin (parent drug and active 25-O-desacetyl metabolite):
Croatian: Rifabutin, 150 mg QD Rifabutin (matični lijek i djelatni 25-O-dezacetilni metabolit):
English: More frequent therapeutic concentration monitoring is recommended until plasma levels of these products have been stabilised.
Croatian: Preporučuju se češće kontrole terapijskih koncentracija, sve dok se koncentracije tih pripravaka u plazmi ne stabiliziraju.
English: Diarrhoea, nausea and vomiting may occur at the beginning of the treatment while hypertriglyceridaemia and hypercholesterolemia may occur later.
Croatian: Proljev, mučnina i povraćanje mogu se pojaviti na početku liječenja dok se hipertrigliceridemija i hiperkolesterolemija mogu javiti kasnije.
English: The effects of Kaletra (in combination with other antiretroviral agents) on biological markers (plasma HIV RNA levels and CD4+ T-cell counts) have been investigated in controlled studies of Kaletra of 48 to 360 weeks duration.
Croatian: Učinci lijeka Kaletra (u kombinaciji s ostalim antiretrovirusnim lijekovima) na biološke biljege (razinu HIV RNK u plazmi i broj CD4+ T stanica) ispitivani su u kontroliranim ispitivanjima lijeka Kaletra u trajanju od 48 do 360 tjedana.
English: The recommended dose of 533/133 mg or 6.5 ml twice daily should not be exceeded.
Croatian: Ne smije se premašiti preporučena doza od 533/133 mg ili 6,5 ml dvaput na dan.
English: • Joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement as some patients taking these medicines may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Croatian: • Ukočenost zglobova, tupi bolovi i probadanja (osobito u kuku, koljenu i ramenu) i teškoće u kretanju jer neki bolesnici koji uzimaju ove lijekove mogu razviti bolest kostiju koja se naziva osteonekroza (odumiranje tkiva kostiju zbog gubitka opskrbe krvlju).
English: If you or your child take more Kaletra than you should
Croatian: Ako Vi ili Vaše dijete uzmete više lijeka Kaletra nego što ste trebali
English: If the benefit is considered to outweigh the risk and Kaletra must be used, patients should be carefully monitored for safety.
Croatian: Ukoliko se smatra da korist nadmašuje rizik i lijek Kaletra se mora koristiti, bolesnike treba pažljivo nadzirati zbog sigurnosti.
English: Total amounts of alcohol and propylene glycol from all medicines that are to be given to infants should be taken into account in order to avoid toxicity from these excipients.
Croatian: Moraju se uzeti u obzir ukupne količine alkohola i propilenglikola svih lijekova koji će se dati maloj djeci kako bi se izbjegla toksičnost ovih pomoćnih tvari.
English: The extent of increase depends on the timing of ritonavir administration.
Croatian: Opseg povećanja ovisi o vremenu primjene ritonavira.
English: Interactions with medicinal products
Croatian: Interakcije s lijekovima
English: Astemizole, terfenadine
Croatian: Astemizol, terfenadin
English: Driving or using machines
Croatian: Upravljanje vozilima i strojevima
English: Volume of oral solution twice daily taken with food (80 mg lopinavir/20 mg ritonavir per ml)**
Croatian: Volumen oralne otopine za primjenu dvaput na dan s hranom (80 mg lopinavira/ 20 mg ritonavira po ml)**
English: Weight (kg)
Croatian: Tjelesna težina (kg)
English: • an abnormality in your electrocardiogram (ECG) called atrioventricular block;
Croatian: • promjene na elektrokardiogramu (EKG) koje se zovu atrioventrikularni blok;
English: • avanafil or vardenafil (used to treat erectile dysfunction);
Croatian: • avanafil ili vardenafil (lijek za liječenje erektilne disfunkcije);
English: • elbasvir/grazoprevir (used to treat chronic hepatitis C virus [HCV]);
Croatian: • elbasvir/grazoprevir (za liječenje kronične infekcije virusom hepatitisa C [HCV]);
English: Dosage recommendation for paediatric patients aged from 14 days to 6 months
Croatian: Preporuke za doziranje u pedijatrijskih bolesnika u dobi od 14 dana do 6 mjeseci
English: The systemic exposure to lopinavir/ritonavir at the maternal and developmental toxic dosages was lower than the intended therapeutic exposure in humans.
Croatian: Sistemska izloženost lopinaviru/ritonaviru pri dozama koje su izazvale materinsku i razvojnu toksičnost, bila je manja od one koja se pri terapijskim dozama očekuje u ljudi.
English: Based on the findings in a paediatric study (observed exposures were approximately 35% AUC12 and 75% lower Cmin than in adults), young children from 14 days to 3 months could have sub-optimal exposure with a potential risk of inadequate virologic suppression and emergence of resistance (see section 5.2).
Croatian: Temeljem nalaza iz jednog pedijatrijskog ispitivanja (opažene izloženosti bile su približno 35% niža vrijednost AUC12 i 75% niži Cmin nego u odraslih), u male djece u dobi od 14 dana do 3 mjeseca izloženost bi mogla biti manja od optimalne, uz mogući rizik od nedovoljne supresije virusa i razvoja rezistencije (vidjeti dio 5.2).