FrancophonIA/ELRC3.0 huggingface dataset:
English: This combination may increase the risk for lactic acidosis in patients with moderate renal impairment (stage 3a creatinine clearance [CrCl] 45- 59 mL/min) and a cautious approach is recommended.
Croatian: Ova kombinacija može povisiti rizik pojave laktacidoze u bolesnika s umjerenim oštećenjem bubrežne funkcije (stupanj 3a, klirens kreatinina [CrCl] 45- 59 ml/min) te se preporučuje oprezni pristup.
English: If the patient misses a dose of Tivicay, the patient should take Tivicay as soon as possible, providing the next dose is not due within 4 hours.
Croatian: Ako bolesnik propusti dozu lijeka Tivicay, treba je uzeti što je prije moguće, pod uvjetom da do sljedeće doze nije preostalo manje od 4 sata.
English: In addition, no antagonistic effects were seen for dolutegravir and adefovir, and ribavirin had no apparent effect on dolutegravir activity.
Croatian: Osim toga, nisu primijećeni antagonistički učinci kod primjene dolutegravira i adefovira, a ribavirin nije vidno utjecao na djelovanje dolutegravira.
English: Tivicay is used to treat HIV (human immunodeficiency virus) infection in adults, adolescents and children over 6 years old, who weigh at least 15 kg.
Croatian: Tivicay se koristi za liječenje infekcije HIV-om (virusom humane imunodeficijencije) u odraslih osoba, adolescenata i djece starije od 6 godina, tjelesne težine od najmanje 15 kg.
English: → Talk to your doctor about the risks and benefits of taking Tivicay.
Croatian: Razgovarajte sa svojim liječnikom o rizicima i prednostima liječenja lijekom Tivicay.
English: Cohort I (12 to <18 years) (n=23)
Croatian: Kohorta I (12 do <18 godina) (n=23)
English: Tivicay has not been studied in patients on dialysis.
Croatian: Tivicay nije ispitivan u bolesnika na dijalizi.
English: Creatinine increases were comparable by various background regimens.
Croatian: Povećanja vrijednosti kreatinina bila su usporediva kod primjene različitih osnovnih režima liječenja.
English: Over the preweaning treatment period, mean body weight gain was decreased in this group and the decrease persisted throughout the entire study for females during the postweaning period.
Croatian: Tijekom liječenja u razdoblju prije prestanka sisanja, srednja vrijednost prirasta tjelesne težine bila je smanjena u ovoj skupini, a to se smanjenje održalo tijekom cijelog ispitivanja kod ženki tijekom razdoblja nakon prestanka sisanja.
English: Preliminary data from a surveillance study has suggested an increased incidence of neural tube defects (0.9%) in mothers exposed to dolutegravir at the time of conception compared with mothers exposed to nondolutegravir containing regimens (0.1%).
Croatian: Preliminarni podaci iz ispitivanja s ciljem praćenja upućuju na porast incidencije defekata neuralne cijevi (0,9 %) u majki izloženih dolutegraviru u vrijeme začeća u odnosu na majke koje su bile izložene režimima koji ne sadržavaju dolutegravir (0,1 %).
English: Co-administration with dofetilide (see section 4.5).
Croatian: Istodobna primjena s dofetilidom (vidjeti dio 4.5).
English: Do not use this medicine after the expiry date which is stated after EXP on the carton and bottle.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i boci iza oznake "EXP".
English: There are no data on the effects of dolutegravir on human male or female fertility.
Croatian: Nema podataka o učincima dolutegravira na plodnost muškaraca ili žena.
English: Like all medicines, this medicine can cause side effects, but not everybody gets them.
Croatian: Moguće nuspojave Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: Dolutegravir has a terminal half-life of ~14 hours.
Croatian: Dolutegravir ima terminalni poluvijek od ~14 sati.
English: Dolutegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral Deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle.
Croatian: Mehanizam djelovanja Dolutegravir inhibira HIV integrazu vezanjem za aktivno mjesto integraze i blokiranjem koraka prijenosa lanca u sklopu integracije retrovirusne deoksiribonukleinske kiseline (DNK), koji je ključan za ciklus replikacije HIV-a.
English: Table 9 Virologic (Snapshot algorithm) and Immunologic Activity of Treatment for Subjects 6 Years and Older in P1093
Croatian: Tablica 9 Virološka (algoritam za globalnu snimku distribuiranog sustava) i imunološka aktivnost liječenja u ispitanika u dobi od 6 i više godina u ispitivanju P1093
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 uputiti da potraže liječničku pomoć ako osjete tupe bolove i probadanja u zglobovima, zglobnu zakočenost ili teškoće pri kretnjama.
English: In animal reproductive toxicity studies, no adverse development outcomes, including neural tube defects, were identified (see section 5.3).
Croatian: U ispitivanjima reproduktivne toksičnosti u životinja nisu primijećeni štetni razvojni ishodi, uključujući defekte neuralne cijevi (vidjeti dio 5.3).
English: Patients should be advised that dolutegravir or any other antiretroviral therapy does not cure HIV infection and that they may still develop opportunistic infections and other complications of HIV infection.
Croatian: Bolesnike treba upozoriti da liječenje dolutegravirom ili bilo kojim drugim antiretrovirusnim lijekom ne može izliječiti HIV infekciju, zbog čega se i dalje mogu javljati oportunističke infekcije i druge komplikacije povezane s HIV infekcijom.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia.
Croatian: Značajni primjeri su retinitis izazvan citomegalovirusom, generalizirane i/ili žarišne mikobakterijske infekcije i Pneumocystis jirovecii pneumonija.
English: No relevant effects were seen on the QTc interval, with doses exceeding the clinical dose by approximately three fold.
Croatian: Nisu primijećeni značajni učinci na QTc interval pri primjeni doza približno trostruko većih od kliničkih doza.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 January 2014
Croatian: Datum prvog odobrenja: 20. siječnja 2014.
English: Cohort IIA (6 to <12 years) (n=23)
Croatian: Kohorta IIA (6 do <12 godina) (n=23)
English: 20 mg once daily (Taken as two 10 mg tablets)
Croatian: 20 mg jedanput na dan (primijenjena kao dvije tablete od 10 mg)
English: 15 to less than 20
Croatian: 15 do manje od 20
English: It is not known whether the ingredients of Tivicay can pass into your breast milk.
Croatian: Nije poznato mogu li sastojci lijeka Tivicay prijeći u majčino mlijeko.
English: Raltegravir/elvitegravir was part of the current failing regimen in 98/183 patients (part of prior failing therapies in the others).
Croatian: Raltegravir/elvitegravir je bio dio trenutnog neuspješnog režima liječenja u 98/183 bolesnika
English: In further selection experiments using clinical isolates of subtype B, mutation R263K was seen in all five isolates (after 20 weeks and onwards).
Croatian: U daljnjim selekcijskim pokusima na kliničkim izolatima podvrste B, mutacija R263K primijećena je kod svih pet izolata (od 20. tjedna nadalje).
English: Taking Tivicay at the time of becoming pregnant or during the first twelve weeks of pregnancy, may increase the risk of a type of birth defect, called neural tube defect, such as spina bifida (malformed spinal cord).
Croatian: Ako uzimate lijek Tivicay u vrijeme začeća ili tijekom prvih dvanaest tjedana trudnoće, povećava se rizik od urođene mane pod nazivom defekt neuralne cijevi, kao što je spina bifida (rascjep kralježnice).
English: In 100% human serum, the mean protein fold shift was 75 fold, resulting in protein adjusted IC90 of 0.064 µg/mL.
Croatian: U 100%-tnom ljudskom serumu srednja vrijednost promjene ekspresije proteina iznosila je 75 puta, što je za posljedicu imalo vrijednost IC90 prilagođenu za proteine od 0,064 μg/ml.
English: There is no specific treatment for an overdose of dolutegravir.
Croatian: Nema specifičnog liječenja za predoziranje dolutegravirom.
English: The mechanism for the decrease is unknown.
Croatian: Mehanizam koji uzrokuje smanjenje izloženosti je nepoznat.
English: • aches and pains in the joints (especially in the hip, knee or shoulder)
Croatian: • tupe bolove i probadanja u zglobovima (osobito u kuku, koljenu ili ramenu) • otežano kretanje.
English: It is unknown if all or part of this is due to unabsorbed active substance or biliary excretion of the glucuronidate conjugate, which can be further degraded to form the parent compound in the gut lumen.
Croatian: Nije poznato je li sve ili samo dio toga posljedica neapsorpcije djelatne tvari ili izlučivanja glukuronidacijskog konjugata putem žuči, koji se u lumenu crijeva može dalje razgraditi i činiti ishodišni spoj.
English: No data are available in subjects receiving dialysis although differences in pharmacokinetics are not expected in this population (see section 5.2).
Croatian: Nema dostupnih podataka o bolesnicima na dijalizi, iako se u toj populaciji ne očekuju razlike u farmakokinetici (vidjeti dio 5.2).
English: Dose recommendations according to weight are presented in table 1.
Croatian: Preporuke za doziranje prema tjelesnoj težini nalaze se u tablici 1.
English: Delay in stopping treatment with dolutegravir or other suspect active substances after the onset of hypersensitivity may result in a life-threatening allergic reaction.
Croatian: Odgađanje prekida liječenja dolutegravirom ili drugim suspektnim djelatnim tvarima nakon pojave preosjetljivosti može uzrokovati po život opasne alergijske reakcije.
English: Increases in serum creatinine occurred within the first week of treatment with dolutegravir and remained stable through 48 weeks.
Croatian: Povećanje koncentracije kreatinina u serumu nastupilo je u prvome tjednu liječenja dolutegravirom, nakon čega su vrijednosti bile stabilne do 48. tjedna.
English: Therefore, patients should remain under close clinical observation by physicians experienced in the treatment of these associated HIV diseases.
Croatian: Stoga bolesnici moraju biti pod strogim kliničkim nadzorom liječnika s iskustvom u liječenju bolesti povezanih s HIV infekcijom.
English: Table 2: Drug Interactions Medicinal products by therapeutic areas
Croatian: Tablica 2 Interakcije s drugim lijekovima Lijekovi po terapijskim područjima
English: Response was associated with baseline INI mutation pathway, as shown in Table 7.
Croatian: Odgovor je bio povezan s putom INI mutacije na početku liječenja, kao što je prikazano u Tablici 7.
English: Dolutegravir belongs to a group of anti-retroviral medicines called integrase inhibitors (INIs).
Croatian: Dolutegravir pripada skupini antiretrovirusnih lijekova koji se zovu inhibitori integraze.
English: GlaxoSmithKline Pharmaceuticals S.A., ul., Grunwaldzka 189, 60-322 Poznan, Poland.
Croatian: GlaxoSmithKline Pharmaceuticals S.A., ul., Grunwaldzka 189, 60-322 Poznan, Poljska.
English: In vivo, dolutegravir may increase plasma concentrations of medicinal products in which excretion is dependent upon OCT2 or MATE-1 (e.g. dofetilide, metformin) (see Table 2 and section 4.3).
Croatian: In vivo dolutegravir može povećati plazmatske koncentracije lijekova čije izlučivanje ovisi o OCT2 ili MATE-1 (npr. dofetilid, metformin) (vidjeti Tablicu 2 i dio 4.3).
English: It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Croatian: Preporučuje se da žene s HIV infekcijom ni pod kojim uvjetom ne doje svoju novorođenčad, kako bi se izbjegao prijenos HIV-a.
English: With this condition, parts of the bone tissue die because of reduced blood supply to the bone.
Croatian: Kod te bolesti dijelovi koštanog tkiva odumiru zbog smanjenog dotoka krvi u kosti.
English: Patients should be informed that dizziness has been reported during treatment with dolutegravir.
Croatian: Bolesnike treba upozoriti da je tijekom liječenja dolutegravirom prijavljena omaglica.
English: The day 8 responses in this placebo controlled study were fully in line with those seen in VIKING-3 (not placebo controlled), including by baseline integrase resistance categories.
Croatian: Odgovori nakon 8 dana u ovom placebom kontroliranom ispitivanju bili su potpuno u skladu s onima viđenima u ispitivanju VIKING-3 (koje nije bilo kontrolirano placebom), pa tako i prema kategorijama rezistencije integraze na početku ispitivanja.
English: In contrast, starting with mutants harbouring mutation Q148H (FC 1), a variety of secondary mutations were seen with a consequent increase of FC to values >10.
Croatian: Nasuprot tome, ako je pasaža započela s mutantima koji su imali mutaciju Q148H (FC 1), primijećen je niz sekundarnih mutacija i posljedičan porast vrijednosti FC na >10.
English: Dolutegravir should be administered twice daily in this population when co-administered with some medicines (e.g. efavirenz, nevirapine, tipranavir/ritonavir, or rifampicin).
Croatian: Dolutegravir se u toj populaciji mora primjenjivati dvaput na dan ako se uzima istodobno s nekim lijekovima (npr. efavirenzom, nevirapinom, tipranavirom/ritonavirom ili rifampicinom).
English: Established and theoretical interactions with selected antiretrovirals and non-antiretroviral medicinal products are listed in Table 2.
Croatian: Potvrđene i teorijske interakcije s odabranim antiretrovirusnim lijekovima i lijekovima koji nisu antiretrovirotici navedene su u Tablici 2. Tablica interakcija
English: The overall susceptibility score (OSS) of the optimised background regimen (OBR) was not associated with Week 24 response, nor with the week 48 response.
Croatian: Rezultat ukupne osjetljivosti (engl. overall susceptibility score, OSS) na optimizirani osnovni režim liječenja (engl. optimised background regimen, OBR) nije bio povezan s odgovorom nakon 24 tjedna niti s odgovorom nakon 48 tjedana.
English: Extremadura 3, 09400 Aranda de Duero, Burgos, Spain GlaxoSmithKline Pharmaceuticals S.A., ul., Grunwaldzka 189, 60-322 Poznan, Poland.
Croatian: Extremadura 3, 09400 Aranda de Duero, Burgos, Španjolska GlaxoSmithKline Pharmaceuticals S.A., ul., Grunwaldzka 189, 60-322 Poznan, Poljska.
English: 35 mg once daily (Taken as one 25 mg and one 10 mg tablet)
Croatian: 35 mg jedanput na dan (primijenjena kao jedna tableta od 25 mg i jedna tableta od 10 mg)
English: Children and adolescents weighing at least 40 kg can take the adult dose of one tablet (50 mg), once a day.
Croatian: Djeca i adolescenti tjelesne težine od najmanje 40 kg mogu uzimati dozu namijenjenu odraslim osobama - jednu tabletu (50 mg) jedanput na dan.
English: If you could get pregnant while receiving Tivicay, you need to use a reliable method of barrier contraception (for example, a condom) with other methods of contraception including oral (pill) or other hormonal contraceptives (for example, implants, injection), to prevent pregnancy.
Croatian: Ako biste mogli zatrudnjeti dok primate lijek Tivicay, morate primjenjivati pouzdanu metodu barijerne kontracepcije (na primjer kondom) uz druge metode kontracepcije, uključujući oralne
English: Treatment-emergent mutations or mixtures of mutations observed were L74I (n=1), N155H (n=2).
Croatian: Primijećene mutacije uzrokovane liječenjem ili kombinacije mutacija bile su L74I (n=1), N155H (n=2).
English: With 50 mg twice daily, the exposure over 24 hours was approximately doubled compared to 50 mg once daily.
Croatian: Kod primjene doze od 50 mg dvaput na dan, izloženost tijekom 24 sata približno se udvostručila u odnosu na primjenu doze od 50 mg jedanput na dan.
English: The mean IC50 for 3 HIV-2 isolates was 0.18 nM (range 0.09-0.61).
Croatian: Srednja vrijednost IC50 za 3 izolata HIV-2 iznosila je 0,18 nM (raspon: 0,09-0,61).
English: Based on limited available data in children and adolescents (6 to less than 18 years of age and weighing at least 15 kg), there were no additional types of adverse reactions beyond those observed in the adult population.
Croatian: S obzirom na ograničene podatke o djeci i adolescentima (u dobi od 6 do manje od 18 godina i tjelesne težine od najmanje 15 kg), nisu primijećene dodatne vrste nuspojava u odnosu na one primijećene u odraslih bolesnika.
English: The bottles contain 30 or 90 film-coated tablets.
Croatian: Boce sadrže 30 ili 90 filmom obloženih tableta.
English: Dolutegravir is also a substrate of UGT1A3, UGT1A9, CYP3A4, Pgp, and BCRP; therefore medicinal products that induce those enzymes may decrease dolutegravir plasma concentration and reduce the therapeutic effect of dolutegravir (see Table 2).
Croatian: Dolutegravir je i supstrat za UGT1A3, UGT1A9, CYP3A4, P-gp i BCRP; stoga lijekovi koji induciraju navedene enzime mogu smanjiti koncentracije dolutegravira u plazmi i tako oslabiti terapijski učinak dolutegravira (vidjeti
English: Dolutegravir ↔ (Not studied)
Croatian: nelfinavir dolutegravir ↔ (interakcija nije ispitivana)
English: Interactions between dolutegravir and co-administered medicinal products are listed in Table 2 (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, area under the concentration versus time curve as “AUC”, maximum observed concentration as “Cmax”, concentration at end of dosing interval as “Cτ”).
Croatian: Interakcije između dolutegravira i istodobno primijenjenih lijekova navedene su u Tablici 2 (povećanje je označeno kao “↑”, smanjenje kao “↓”, stanje bez promjene kao “↔”, površina ispod krivulje koncentracija-vrijeme kao “AUC”, maksimalna zabilježena koncentracija kao “Cmax”, a koncentracija na kraju intervala doziranja kao “Cτ”).
English: How to take Tivicay
Croatian: Kako uzimati Tivicay
English: 30 to less than 40
Croatian: 30 do manje od 40
English: Dolutegravir had no pharmacodynamic effect on Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH) and progesterone.
Croatian: Dolutegravir nije utjecao na farmakodinamiku luteinizirajućeg hormona (LH), folikulostimulirajućeg hormona (FSH)
English: Virologic non-response†
Croatian: Izostanak virološkog odgovora†
English: If you take too many tablets of Tivicay, contact your doctor or pharmacist for advice.
Croatian: Ako slučajno uzmete previše Tivicay tableta, obratite se svom liječniku ili ljekarniku za savjet.
English: Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Croatian: Ovakve su se reakcije uobičajeno javljale unutar prvih nekoliko tjedana ili mjeseci nakon uvođenja kombinirane antiretrovirusne terapije.
English: 4.6 Fertility, pregnancy and lactation Women of childbearing potential
Croatian: 4.6 Plodnost, trudnoća i dojenje
English: When excluding patients who stopped therapy for non-efficacy reasons, and those with major protocol deviations (incorrect dolutegravir dosing, intake of prohibited co-medication), namely, “the Virological Outcome (VO)-population)”, the corresponding response rates were 75% (120/161, week 24) and 69% (111/160, week 48).
Croatian: Nakon isključivanja bolesnika koji su prekinuli terapiju zbog nedjelotvornosti te bolesnika u kojih je došlo do značajnih odstupanja u protokolu (netočno doziranje dolutegravira, primjena zabranjenih lijekova), odnosno “populacije s virološkim ishodom”, odgovarajuće stope odgovora iznosile su 75% (120/161, 24. tjedan) i 69% (111/160, 48. tjedan).
English: In vitro, dolutegravir demonstrated no direct, or weak inhibition (IC50>50 μM) of the enzymes cytochrome P450 (CYP)1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 CYP3A, uridine diphosphate glucuronosyl transferase (UGT)1A1 or UGT2B7, or the transporters Pgp, BCRP, BSEP, OATP1B1, OATP1B3, OCT1, MATE2-K, MRP2 or MRP4.
Croatian: In vitro dolutegravir nije pokazao ni izravnu ni slabu inhibiciju (IC50 > 50 μM) enzima citokroma P450 (CYP)1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A, uridin difosfat glukuronoziltransferaze (UGT)1A1 ili UGT2B7 niti prijenosnika P-gp, BCRP, BSEP, OATP1B1, OATP1B3, OCT1, MATE2-K, MRP2 ili MRP4.
English: When using the lab-strain HIV-1 IIIB during passage over 112 days, mutations selected appeared slowly, with substitutions at positions S153Y and F, resulting in a maximal fold change in susceptibility of 4 (range 2-4).
Croatian: Pri korištenju laboratorijskog soja HIV-1 IIIB za vrijeme pasaže tijekom 112 dana, odabrane mutacije pojavljivale su se polako, sa supstitucijama na položajima S153Y i F, što je za posljedicu imalo maksimalnu promjenu (engl. fold change, FC) u osjetljivosti od 4 (raspon: 2-4).
English: Of these four, two subjects had a unique R263K integrase substitution, with a maximum FC of 1.93, one subject had a polymorphic V151V/I integrase substitution, with maximum FC of 0.92, and one subject had pre-existing integrase mutations and is assumed to have been integrase experienced or infected with integrase resistant virus by transmission.
Croatian: Od ta četiri ispitanika, dva su imala jedinstvenu supstituciju R263K na integrazi uz maksimalni FC od 1,93, jedan je imao polimorfnu supstituciju V151V/I na integrazi uz maksimalni FC od 0,92, a jedan je ispitanik imao otprije postojeće mutacije integraze te se pretpostavlja da je prethodno primao inhibitore integraze ili da je prijenosom bio zaražen virusom rezistentnim na inhibitore integraze.
English: The E92Q mutation has been selected in patients with pre-existing raltegravir resistance who were then treated with dolutegravir (listed as a secondary mutation for dolutegravir).
Croatian: Mutacija E92Q izdvojena je u bolesnika s već postojećom rezistencijom na raltegravir koji su liječeni dolutegravirom (navodi se kao sekundarna mutacija za dolutegravir).
English: • calcium supplements, iron supplements and multivitamins.
Croatian: • nadomjeske kalcija, nadomjeske željeza i multivitaminske pripravke.
English: As dolutegravir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by dialysis.
Croatian: Budući da se dolutegravir u velikoj mjeri veže za proteine u plazmi, nije vjerojatno da će se značajno ukloniti dijalizom.
English: This is supported by 96 week data from an open-label, randomized and activecontrolled study FLAMINGO (ING114915) and additional data from the open-label phase of SINGLE to 144 weeks.
Croatian: Podupiru ih i podaci prikupljeni tijekom 96 tjedana u otvorenom, randomiziranom i aktivno kontroliranom ispitivanju FLAMINGO (ING114915) i dodatni podaci iz otvorene faze ispitivanja SINGLE do 144. tjedna.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release GLAXO WELLCOME, S.A., Avda.
Croatian: Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet GLAXO WELLCOME, S.A., Avda.
English: - This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po jediničnoj dozi, tj. zanemarive količine natrija.
English: Pharmacokinetic data for dolutegravir in subjects >65 years of age are limited.
Croatian: Farmakokinetički podaci o primjeni dolutegravira u ispitanika starijih od 65 godina su ograničeni.
English: Dolutegravir is eliminated mainly through metabolism by UGT1A1.
Croatian: Dolutegravir se uglavnom eliminira metabolizmom posredstvom UGT1A1.
English: The systemic exposure at this dose (based on AUC) to dolutegravir was ~17-20-fold higher than humans at the recommended pediatric exposure.
Croatian: Sistemska izloženost dolutegraviru pri toj dozi (na temelju AUC-a) bila je ~17 - 20 puta veća od izloženosti u ljudi kod preporučene pedijatrijske izloženosti.
English: No data are available in patients with severe hepatic impairment (Child-Pugh grade C); therefore dolutegravir should be used with caution in these patients (see section 5.2).
Croatian: Nema dostupnih podataka o bolesnicima s teškim oštećenjem jetrene funkcije (Child-Pugh stadij C) pa se u tih bolesnika dolutegravir mora primjenjivati uz oprez (vidjeti dio 5.2).
English: Rare side effects These may affect up to 1 in 1000 people:
Croatian: Rijetke nuspojave Mogu se javiti u do 1 na 1000 osoba: