FrancophonIA/ELRC3.0 huggingface dataset:
English: Monitoring of liver biochemistries is recommended in patients with hepatitis B and/or C co-infection.
Croatian: U bolesnika s istodobnom infekcijom hepatitisom B i/ili C preporučuje se praćenje biokemijskih parametara jetre.
English: Patients with prior treatment failure that included an integrase inhibitor (and integrase class resistance) In the multicentre, open-label, single arm VIKING-3 study (ING112574), HIV-1 infected, ART-experienced adults with virological failure and current or historical evidence of raltegravir and/or elvitegravir resistance received Tivicay 50 mg twice daily with the current failing background regimen for 7 days but with optimised background ART from Day 8.
Croatian: U multicentričnom, otvorenom ispitivanju VIKING-3 (ING112574) s jednom skupinom, odrasli bolesnici s HIV-1 infekcijom koji su prethodno liječeni antiretroviroticima i imali virološki neuspjeh i dokaze trenutno ili ranije postojeće rezistencije na raltegravir i/ili elvitegravir, primali su Tivicay u dozi od 50 mg dvaput na dan, prvih 7 dana u kombinaciji s trenutnim neuspješnim osnovnim režimom liječenja, a od 8. dana nadalje s optimiziranom osnovnom antiretrovirusnom terapijom.
English: Population PK analyses using pooled pharmacokinetic data from Phase IIb and Phase III adult trials revealed no clinically relevant effect of race on the exposure of dolutegravir.
Croatian: Populacijska farmakokinetička analiza objedinjenih podataka iz ispitivanja faze IIb i faze III u odraslih bolesnika nije ukazala na klinički značajan učinak rase na izloženost dolutegraviru.
English: In FLAMINGO (ING114915), an open-label, randomised and active-controlled study, 484 HIV-1 infected antiretroviral naïve adults received one dose of either dolutegravir 50 mg once daily (n=242) or darunavir/ritonavir (DRV/r) 800 mg/100 mg once daily (n=242), both administered with either ABC/3TC or TDF/FTC.
Croatian: odrasle osobe s HIV-1 infekcijom koje prethodno nisu bile liječene antiretrovirusnim lijekovima primile su jednu dozu dolutegravira od 50 mg jedanput na dan (n=242) ili darunavir/ritonavir (DVR/r) u dozi od 800 mg/100 mg jedanput na dan (n=242); oba su se režima primjenjivala uz ABC/3TC ili
English: Population PK analyses using pooled pharmacokinetic data from Phase IIb and Phase III adult trials revealed no clinically relevant effect of gender on the exposure of dolutegravir.
Croatian: Populacijska farmakokinetička analiza objedinjenih podataka iz ispitivanja faze IIb i faze III u odraslih bolesnika nije ukazala na klinički značajan učinak spola na izloženost dolutegraviru.
English: † Includes subjects who changed BR to new class or changed BR not permitted per protocol or due to lack of efficacy prior to Week 48 (for SPRING-2 only), subjects who discontinued prior to Week 48 for lack or loss of efficacy and subjects who are ≥50 copies in the 48 week window.
Croatian: † Uključuje ispitanike koji su prije 48. tjedna prešli s osnovnog režima liječenja na novu skupinu lijekova ili su promijenili osnovni režim liječenja jer nije bio dopušten prema protokolu ili nije bio dovoljno djelotvoran (samo u ispitivanju SPRING-2), ispitanike koji su prekinuli liječenje prije
English: The clinical status of the patient and the adverse reaction profile of dolutegravir should be borne in mind when considering the patient's ability to drive or operate machinery.
Croatian: Kada se razmatra bolesnikova sposobnost upravljanja vozilima ili rada sa strojevima, treba imati na umu kliničko stanje bolesnika i profil nuspojava dolutegravira.
English: Do not remove the desiccant.
Croatian: Ne uklanjati sredstvo za sušenje.
English: Median baseline CD4+ was 140 cells/mm3, median duration of prior ART was 14 years, and 56% were CDC Class C. Subjects showed multiple class ART resistance at baseline: 79% had ≥2
Croatian: Medijan vrijednosti CD4+ stanica na početku ispitivanja iznosio je 140 stanica/mm3, medijan trajanja prethodne antiretrovirusne terapije iznosio je 14 godina, a 56% bolesnika imalo je HIV infekciju kategorije C prema CDC klasifikaciji.
English: HIV-1 RNA <50 copies/mL by baseline covariates
Croatian: HIV-1 RNK < 50 kopija/ml prema početnim kovarijatama
English: The primary effect of dolutegravir was gastrointestinal intolerance or irritation in rats and monkeys at doses that produce systemic exposures approximately 21 and 0.82 times the 50 mg twice daily human clinical exposure based on AUC, respectively.
Croatian: Primarni učinak dolutegravira bile su gastrointestinalna nepodnošljivost ili iritacija u štakora odnosno majmuna pri dozama koje su izazvale sistemsku izloženost približno 21 odnosno
English: In vitro, dolutegravir did not induce CYP1A2, CYP2B6 or CYP3A4.
Croatian: In vitro dolutegravir nije inducirao CYP1A2,
English: Tivicay 10 mg film-coated tablets Tivicay 25 mg film-coated tablets Tivicay 50 mg film-coated tablets dolutegravir
Croatian: Tivicay 10 mg filmom obložene tablete Tivicay 25 mg filmom obložene tablete Tivicay 50 mg filmom obložene tablete
English: The recommended adult dose of dolutegravir is 50 mg twice daily when co-administered with these metabolic inducers.
Croatian: Preporučena doza dolutegravira u odraslih je 50 mg dvaput na dan kad se istodobno primjenjuje s navedenim metaboličkim induktorima.
English: ≤100,000 cps/mL
Croatian: ≤ 50 000 kopija/ml > 50 000 kopija/ml
English: Tivicay is one 50 mg tablet, twice a day.
Croatian: Preporučena doza dolutegravira je 50 mg (jedna tableta) dvaput na dan.
English: Dolutegravir ↓ AUC ↓ 33% Cmax ↓ 35% C24 ↓ 32% (Complex binding to polyvalent ions)
Croatian: multivitaminski pripravci dolutegravir ↓ AUC ↓ 33% Cmax ↓ 35% C24 ↓ 32% (stvaranje kompleksa s polivalentnim ionima)
English: At baseline, median patient age was 49 years, 20% were female, 58% non-white, and 23% had hepatitis B and/or C co-infection.
Croatian: Na početku liječenja, medijan dobi bolesnika iznosio je 49 godina, 20% ispitanika bile su žene, 58% ispitanika nisu bili bijelci, i 23% je istodobno imalo infekciju hepatitisom B i/ili C.
English: No dose adjustment is necessary of either agent.
Croatian: Nije potrebno prilagođavati dozu niti jednoga od ovih dvaju lijekova.
English: → Talk to your doctor for further advice on taking calcium supplements, iron supplements or multivitamins with Tivicay.
Croatian: Za dodatne savjete o uzimanju nadomjestaka kalcija, nadomjestaka željeza ili multivitaminskih pripravaka zajedno s lijekom Tivicay, razgovarajte sa svojim liječnikom.
English: The study enrolled 183 patients, 133 with INI-resistance at Screening and 50 with only historical evidence of resistance (and not at Screening).
Croatian: U ispitivanje je uključeno 183 bolesnika, od kojih je pri probiru njih 133 imalo rezistenciju na inhibitore integraze,
English: The apparent oral clearance (CL/F) is approximately 1L/hr in HIV-infected patients based on a population pharmacokinetic analysis.
Croatian: Na temelju populacijske farmakokinetičke analize, prividni klirens nakon peroralne primjene (CL/F) u bolesnika s HIV infekcijom iznosi približno 1 l/h.
English: In SINGLE, dolutegravir + ABC/3TC was still superior to EFV/TDF/FTC (viral suppression in 80% vs 72%, treatment difference 8.0% (2.3, 13.8), p=0.006, and with an adjusted mean change in CD4 count of 325 vs 281 cells/ mm3, respectively.
Croatian: U ispitivanju SINGLE, kombinacija dolutegravir + ABC/3TC i dalje je bila superiorna u odnosu na EFV/TDF/FTC (virusna supresija postignuta je u 80% naspram 72% bolesnika), uz razliku između liječenja od 8,0% (2,3; 13,8),
English: Interaction Geometric mean change
Croatian: Promjena geometrijske srednje vrijednosti (%)
English: INFORMATION IN BRAILLE tivicay 50 mg
Croatian: tivicay 50 mg
English: At baseline, median patient age was 48 years, 23% were female, 29% non-white, and 20% had hepatitis B and/or C co-infection.
Croatian: Na početku je ispitivanja medijan dobi bolesnika iznosio 48 godina, 23% bolesnika bile su žene, 29% bolesnika nije bilo bijele rase, a 20% bolesnika imalo je istodobnu infekciju hepatitisom B i/ili C.
English: How to store Tivicay
Croatian: Moguće nuspojave Kako čuvati Tivicay
English: Do not give this medicine to children under 6 years of age, weighing less than 15 kg or with HIV infection that is resistant to other medicines similar to Tivicay.
Croatian: Ovaj lijek se ne smije davati djeci mlađoj od 6 godina, djeci tjelesne težine manje od 15 kg ni djeci s
English: • difficulty moving.
Croatian: • otežano disanje
English: Dolutegravir ↔ AUC ↑ 1% Cmax ↓ 3% Cτ ↓ 8% Tenofovir ↔
Croatian: Nukleozidni inhibitori reverzne transkriptaze tenofovir dolutegravir ↔ AUC ↑ 1% Cmax ↓ 3% Cτ ↓ 8% tenofovir ↔
English: INFORMATION IN BRAILLE tivicay 25 mg
Croatian: tivicay 25 mg
English: • dizziness
Croatian: • mučnina.
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Croatian: Tablica 3 Nuspojave
English: At baseline, in the pooled analysis, median patient age was 33 years, 15% were female, 32% non-white, 6% had hepatitis C co-infection and 9% were CDC Stage 3.
Croatian: Na temelju analize objedinjenih podataka, na početku je ispitivanja medijan dobi bolesnika iznosio 33 godine, 15% ispitanika bile su žene, 32% ispitanika nisu bili bijelci, 6% ih je imalo istodobnu infekciju hepatitisom C, a 9% ispitanika imalo je HIV infekciju stadija 3 prema CDC klasifikaciji.
English: Tel: + 34 902 051 260 es-ci@viivhealthcare.com
Croatian: Tel: + 351 21 094 08 01 viiv.fi.pt@viivhealthcare.com
English: • joint pain, stiffness and bone problems You need to know about important signs and symptoms to look out for while you're taking Tivicay.
Croatian: Morate znati na koje važne znakove i simptome treba pripaziti tijekom liječenja lijekom Tivicay.
English: Liver biochemistry elevations consistent with immune reconstitution syndrome were observed in some hepatitis B and/or C co-infected patients at the start of dolutegravir therapy.
Croatian: U nekih bolesnika s istodobnom infekcijom hepatitisom B i/ili C, u skladu sa sindromom imunološke rekonstitucije, primijećena su povišenja biokemijskih pokazatelja jetrene funkcije na početku liječenja dolutegravirom.
English: If you notice any of these symptoms: → Tell your doctor.
Croatian: Ako primijetite bilo koji od navedenih simptoma:
English: Tivicay should not be used in children and adolescents with HIV infection that is resistant to other medicines similar to Tivicay.
Croatian: HIV infekcijom otpornom na druge lijekove slične lijeku Tivicay.
English: If the next dose is due within 4 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
Croatian: bolesnik ne smije uzeti propuštenu dozu, nego samo nastaviti s primjenom prema uobičajenom rasporedu.
English: The pharmacokinetics of dolutegravir in 10 antiretroviral treatment-experienced HIV-1 infected adolescents (12 to <18 years of age) showed that Tivicay 50 mg once daily oral dosage resulted in dolutegravir exposure comparable to that observed in adults who received Tivicay 50 mg orally once daily.
Croatian: Farmakokinetika dolutegravira u 10 adolescenata (12 do < 18 godina) s HIV-1 infekcijom koji su prethodno liječeni antiretroviroticima pokazala je da peroralna primjena lijeka Tivicay u dozi od
English: The two-drug regimen of dolutegravir 50 mg once daily and lamivudine 300 mg once daily was explored in two large randomized and blinded studies, GEMINI 1 and GEMINI 2 (see section 5.1).
Croatian: Dvojni režim liječenja dolutegravirom u dozi od 50 mg jedanput na dan i lamivudinom u dozi od 300 mg jedanput na dan ispitivao se u dvama velikim randomiziranim i slijepim ispitivanjima,
English: Dolutegravir has a less than or equal to 10 FC against 94% of the 705 clinical isolates.
Croatian: 94% od 705 kliničkih izolata.
English: ≤200 c/ mm3
Croatian: stanice/mm3
English: Patients with prior treatment failure, but not exposed to the integrase class In the international multicentre, double-blind SAILING study (ING111762), 719 HIV-1 infected, antiretroviral therapy (ART)-experienced adults were randomized and received either dolutegravir 50 mg once daily or raltegravir 400 mg twice daily with investigator selected background regimen consisting of up to 2 agents (including at least one fully active agent).
Croatian: 719 odraslih osoba s HIV-1 infekcijom koje su prethodno primale antiretrovirusnu terapiju (ART) randomizirano je u skupinu koja je primala ili dolutegravir u dozi od 50 mg jedanput na dan ili raltegravir u dozi od 400 mg dvaput na dan s osnovnim režimom liječenja po izboru ispitivača, koji se sastojao od najviše 2 lijeka (uključujući najmanje jedan potpuno aktivan lijek).
English: In Phase III studies patients with hepatitis B and/or C co-infection were permitted to enrol provided that baseline liver chemistry tests did not exceed 5 times the upper limit of normal (ULN).
Croatian: pod uvjetom da im nalazi pretraga biokemijskih parametara jetre na početku ispitivanja nisu bili više od 5 puta iznad gornje granice normale (GGN).
English: • stomach (abdominal) discomfort
Croatian: • nelagoda u trbuhu (abdomenu)
English: Dolutegravir ↓ AUC ↓ 59% Cmax ↓ 47% Cτ ↓ 76% (induction of UGT1A1 and CYP3A enzymes)
Croatian: dolutegravir ↓ AUC ↓ 59% Cmax ↓ 47% Cτ ↓ 76% (indukcija enzima UGT1A1 i CYP3A)
English: At baseline, median patient age was 36 years, 14% were female, 15% non-white, 11% had hepatitis B and/or C co-infection and 2% were CDC Class C, these characteristics were similar between treatment groups.
Croatian: Na početku ispitivanja medijan dobi bolesnika iznosio je 36 godina, 14% bolesnika bile su žene, 15% bolesnika nisu bili bijelci, 11% bolesnika imalo je istodobnu infekciju hepatitisom B i/ili C, a 2% bolesnika imalo je
English: Dolutegravir ↔ AUC ↓ 5% Cmax ↑ 16% Cτ ↓ 30% (induction of UGT1A1 and CYP3A enzymes)
Croatian: rifabutin dolutegravir ↔ AUC ↓ 5% Cmax ↑ 16% Cτ ↓ 30% (indukcija enzima UGT1A1 i CYP3A)
English: Adults
Croatian: Djeca
English: Laboratorios ViiV Healthcare, S.L.
Croatian: VIIVHIV HEALTHCARE, UNIPESSOAL, LDA
English: Multivitamin
Croatian: NRTI-jem
English: Integrase class resistance of particular concern
Croatian: Osobito važna rezistencija na skupinu inhibitora integraze
English: >100,000 cps/mL By CD4+
Croatian: ≤ 100 000 kopija/ml > 100 000 kopija/ml Prema broju CD4+ stanica ≤ 200 stanica/mm3 > 200 stanica/mm3
English: Nervous system disorders
Croatian: Oštećenje bubrežne funkcije
English: Tivicay 10 mg film-coated tablets are white, round, biconvex tablets marked with the code ‘SV 572' on one side and ‘10' on the other side.
Croatian: Tivicay 10 mg filmom obložene tablete su okrugle, bikonveksne tablete bijele boje s oznakom „SV 572“ s jedne strane i „10“ s druge strane.
English: No dosage adjustment is considered necessary for patients with renal impairment.
Croatian: Prilagođavanje doze u bolesnika s oštećenjem bubrežne funkcije ne smatra se potrebnim.
English: Q148+≥2 secondary mutationsb *Of 98 on RAL/EVG as part of current failing regimen, 88 had detectable primary INI mutations at Baseline and a Day 8 Plasma HIV-1 RNA outcome for evaluation a Included primary IN resistance mutations N155H, Y143C/H/R, T66A, E92Q b Secondary mutations from G140A/C/S, E138A/K/T, L74I.
Croatian: 88 imalo je mjerljive primarne INI mutacije na početku liječenja te ishod za HIV-1 RNK u plazmi 8. dana dostupan za procjenu a Uključujući primarne mutacije uzrokovane rezistencijom integraze: N155H, Y143C/H/R,
English: No dosage adjustment is considered necessary for patients with mild to moderate hepatic impairment.
Croatian: Prilagodba doze u bolesnika s blagim ili umjerenim oštećenjem jetrene funkcije ne smatra se potrebnom.
English: Dolutegravir ↓ AUC ↓ 35% Cmax ↓ 24% Cτ ↓ 49% (induction of UGT1A1 and CYP3A enzymes)
Croatian: dolutegravir ↓ AUC ↓ 35% Cmax ↓ 24% Cτ ↓ 49% (indukcija enzima UGT1A1 i CYP3A)
English: EU/1/13/892/002
Croatian: EU/1/13/892/001 EU/1/13/892/002
English: At baseline, median patient age was 43 years, 32% were female, 50% non-white, 16% had hepatitis B and/or C co-infection, and 46% were CDC Class C. All patients had at least two class ART resistance, and 49% of subjects had at least 3-class ART resistance at baseline.
Croatian: Na početku ispitivanja medijan dobi bolesnika iznosio je 43 godine, 32% bolesnika bile su žene, 50% bolesnika nisu bili bijelci, 16% bolesnika imalo je istodobnu infekciju hepatitisom B i/ili C, a 46% imalo je HIV infekciju kategorije C prema CDC klasifikaciji.
English: VIIVHIV HEALTHCARE, UNIPESSOAL, LDA Tel: + 351 21 094 08 01 viiv.fi.pt@viivhealthcare.com
Croatian: Laboratorios ViiV Healthcare, S.L. Tel: + 34 902 051 260 es-ci@viivhealthcare.com
English: If you are breast-feeding, or thinking about breast-feeding: → Talk to your doctor immediately.
Croatian: Ako dojite ili razmišljate o dojenju:
English: In the SAILING study, virologic suppression (HIV-1 RNA <50 copies/mL) in the Tivicay arm (71%) was statistically superior to the raltegravir arm (64%), at Week 48 (p=0.03).
Croatian: Tivicay (71%) nakon 48 tjedana bila statistički superiorna u odnosu na skupinu koja je primala raltegravir (64%) (p=0,03).
English: Yellow, round, biconvex tablets approximately 9 mm in diameter debossed with ‘SV 572' on one side and ‘50' on the other side.
Croatian: Žute, okrugle, bikonveksne tablete, promjera približno 9 mm, s utisnutom oznakom „SV 572“ s jedne i „50“ s druge strane.
English: >200 c/ mm3 By HIV-1 subtype B
Croatian: Prema podvrsti virusa HIV-1 B
English: Tivicay 25 mg film-coated tablets are pale yellow, round, biconvex tablets marked with the code ‘SV 572' on one side and ‘25' on the other side.
Croatian: Tivicay 25 mg filmom obložene tablete su okrugle, bikonveksne tablete blijedo žute boje s oznakom „SV 572“ s jedne strane i „25“ s druge strane.
English: Very common Headache Common Dizziness
Croatian: Vrlo česte nuspojave
English: White, round, biconvex tablets approximately 6 mm in diameter debossed with ‘SV 572' on one side and ‘10' on the other side.
Croatian: Bijele, okrugle, bikonveksne tablete, promjera približno 6 mm, s utisnutom oznakom „SV 572“ s jedne i „10“ s druge strane.
English: Tivicay 10 mg film-coated tablets
Croatian: Tivicay 10 mg filmom obložene tablete
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL 25 mg film-coated tablets
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA BOCE 25 mg filmom obložene tablete
English: Median baseline CD4+ was 160 cells/mm3, median duration of prior ART was 13 years, and 63% were CDC Class C. Subjects showed multiple class ART resistance at baseline: 80% had ≥2 NRTI, 73% ≥1 NNRTI, and 67% ≥2 PI major mutations; 83% had non-R5 virus.
Croatian: Početni medijan CD+4 bio je 160 stanica/mm3, medijan trajanja prethodne antiretrovirusne terapije (ART) bio je 13 godina, i 63% ispitanika imalo je HIV infekciju kategorije C prema CDC klasifikaciji.
English: Tivicay 50 mg film-coated tablets are yellow, round, biconvex tablets marked with the code ‘SV 572' on one side and ‘50' on the other side.
Croatian: Tivicay 50 mg filmom obložene tablete su okrugle, bikonveksne tablete žute boje s oznakom „SV 572“ s jedne strane i „50“ s druge strane.
English: EU/1/13/892/004
Croatian: EU/1/13/892/003 EU/1/13/892/004
English: At baseline, median patient age was 35 years, 16% were female, 32% nonwhite, 7% had hepatitis C co-infection and 4% were CDC Class C, these characteristics were similar between treatment groups.
Croatian: Na početku ispitivanja medijan dobi bolesnika iznosio je 35 godina, 16% bolesnika bile su žene, 32% bolesnika nisu bili bijelci, 7% bolesnika imalo je istodobnu infekciju hepatitisom C, a 4% bolesnika imalo je
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Table 6 Response in SAILING at 48 Weeks (Snapshot algorithm, <50 copies/mL) Dolutegravir 50 mg Once Daily + BR N=354§
Croatian: Tablica 6 Odgovori u ispitivanju SAILING nakon 48 tjedana (algoritam za globalnu snimku distribuiranog sustava, < 50 kopija/ml)
English: Alternative combinations that do not include St. John's wort should be used where possible in INI-resistant patients.
Croatian: Kad je to moguće potrebno je primijeniti zamjenske kombinacije koje ne uključuju gospinu travu u bolesnika rezistentnih na inhibitore integraze.
English: Elderly
Croatian: Antacidi
English: • For the treatment of HIV that is resistant to other medicines similar to Tivicay, the usual dose of
Croatian: • Za liječenje HIV infekcije otporne na druge lijekove slične lijeku Tivicay, uobičajena doza lijeka Tivicay je jedna tableta od 50 mg dvaput na dan.
English: Pale yellow, round, biconvex tablets approximately 7 mm in diameter debossed with ‘SV 572' on one side and ‘25' on the other side.
Croatian: Blijedo žute, okrugle, bikonveksne tablete, promjera približno 7 mm, s utisnutom oznakom „SV 572“ s jedne i „25“ s druge strane.
English: Each film-coated tablet contains dolutegravir sodium equivalent to 10 mg dolutegravir.
Croatian: Jedna filmom obložena tableta sadrži 10 mg dolutegravira u obliku dolutegravirnatrija.
English: ANNEX II
Croatian: Tablicu 2).
English: The recommended adult dose of dolutegravir is 50 mg twice daily when co-administered with tipranavir/ritonavir.
Croatian: Preporučena doza dolutegravira u odraslih pri istodobnoj primjeni s tipranavirom/ritonavirom iznosi 50 mg dvaput na dan.
English: The recommended adult dose of dolutegravir is 50 mg twice daily when co-administered with efavirenz.
Croatian: Preporučena doza dolutegravira u odraslih je 50 mg dvaput na dan kad se istodobno primjenjuje s karbamazepinom.
English: Tivicay 25 mg film-coated tablets
Croatian: Tivicay 25 mg filmom obložene tablete
English: Etravirine ↔
Croatian: SPRING-2
English: Each film-coated tablet contains dolutegravir sodium equivalent to 25 mg dolutegravir.
Croatian: Jedna filmom obložena tableta sadrži 25 mg dolutegravira u obliku dolutegravirnatrija.
English: Tivicay 50 mg film-coated tablets
Croatian: Tivicay 50 mg filmom obložene tablete
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL 10 mg film-coated tablets
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA BOCE 10 mg filmom obložene tablete
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 25mg film-coated tablets
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 25 mg filmom obložene tablete
English: Dolutegravir ↓ AUC ↓ 22% Cmax ↓ 11% C24 ↓ 38% (induction of UGT1A1 and CYP3A enzymes)
Croatian: darunavir/ritonavir dolutegravir ↓ AUC ↓ 22% Cmax ↓ 11% C24 ↓ 38% (indukcija enzima UGT1A1 i CYP3A)
English: Oral administration of dolutegravir to pregnant rats at doses up to 1000 mg/kg daily from days 6 to 17 of gestation did not elicit maternal toxicity, developmental toxicity or teratogenicity (27 times the 50 mg twice daily human clinical exposure based on AUC).
Croatian: 6. do 17. dana gestacije nije uzrokovala toksičnost za majku, razvojnu toksičnost niti teratogenost (izloženost 27 puta veća od kliničke izloženosti pri primjeni doze od 50 mg dvaput na dan u ljudi, što je utvrđeno na temelju AUC-a).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 10mg film-coated tablets
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 10 mg filmom obložene tablete
English: 2.5% (95% CI: -2.2%, 7.1%)
Croatian: Razlika između liječenja* 2,5% (95% CI: -2,2%; 7,1%) 7,4% (95% CI: 2,5%; 12,3%)
English: EU/1/13/892/006
Croatian: EU/1/13/892/005 EU/1/13/892/006
English: Dolutegravir ↓ (Not studied, decrease expected due to induction of UGT1A1 and CYP3A enzymes, a similar reduction in exposure as observed with carbamazepine is expected)
Croatian: okskarbazepin fenitoin fenobarbital dolutegravir ↓ (interakcija nije ispitivana; očekuje se smanjenje koncentracije zbog indukcije enzima UGT1A1 i CYP3A,
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL 50 mg film-coated tablets
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA BOCE 50 mg filmom obložene tablete
English: Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 43% Cτ ↓72% (induction of UGT1A1 and CYP3A enzymes)
Croatian: Antimikobakterici rifampicin dolutegravir ↓ AUC ↓ 54% Cmax ↓ 43% Cτ ↓72% (indukcija enzima UGT1A1 i CYP3A)