natgillin/translations-raw huggingface dataset:
The apparent volume of distribution is 17 L to 20 L in HIV-infected patients, based on a population pharmacokinetic analysis.
Navidezni volumen porazdelitve pri bolnikih, okuženih s HIV, je na podlagi populacijske farmakokinetične analize od 17 do 20 l. Vezava dolutegravirja na plazemske beljakovine ni odvisna od njegove koncentracije.
Atazanavir/ritonavir Dolutegravir ↑ AUC ↑ 62%
atazanavir/ritonavir dolutegravir ↑ AUC ↑ 62% Cmax ↑ 34% Cτ ↑ 121%
INFORMATION IN BRAILLE tivicay 25 mg
PODATKI V BRAILLOVI PISAVI tivicay 25 mg
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.
Ob izhodišču je bila mediana starost bolnikov 36 let, 14% je bilo žensk, 15% ne-belcev, 11% jih je imelo sočasno okužbo z virusom hepatitisa B in/ali C, 2% pa jih je bilo razvrščenih v CDC razred C; te lastnosti so bile pri obeh terapevtskih skupinah podobne.
In paediatric patients the weightbased once daily dose should be administered twice daily.
Pri pediatričnih bolnikih je treba na podlagi telesne mase določeni dnevni odmerek podvojiti, tako da ga namesto enkrat na dan uporabimo dvakrat na dan.
Dolutegravir ↓ AUC ↓ 25% Cmax ↓ 12% Cτ ↓ 36% DRV ↔ RTV ↔
darunavir/ritonavir + etravirin dolutegravir ↓ AUC ↓ 25 % Cmax ↓ 12 % Cτ ↓ 36 % DRV ↔ RTV ↔
Don't stop taking Tivicay without advice from your doctor Take Tivicay for as long as your doctor recommends.
Ne prenehajte z jemanjem zdravila Tivicay, ne da bi se prej posvetovali z zdravnikom.
The pharmacokinetics was evaluated in 11 children 6 to 12 years of age and showed that 25 mg once daily in patients weighing at least 20 kg and 35 mg once daily in patients weighing at least 30 kg resulted in dolutegravir exposure comparable to adults.
Ugotovili so, da sta odmerka 25 mg enkrat na dan pri bolnikih s telesno maso vsaj 20 kg in 35 mg enkrat na dan pri bolnikih s telesno maso vsaj 30 kg povzročila izpostavljenost dolutegravirju, ki je bila podobna kot pri odraslih.
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.
V njej je 484 bolnikov, okuženih s HIV-1, ki pred tem še niso dobivali protiretrovirusnega zdravljenja, dobivalo bodisi en odmerek 50 mg dolutegravirja enkrat na dan (n = 242) bodisi 800 mg/100 mg kombinacije darunavir/ritonavir (DRV/r) (n = 242), oba uporabljena ali z ABC/3TC ali TDF/FTC.
Tivicay should not be dosed higher than 50 mg twice daily in combination with atazanavir (see section 5.2) due to lack of data.
Zaradi pomanjkanja podatkov se zdravila Tivicay v kombinaciji z atazanavirjem ne sme uporabljati v odmerku, večjem od 50 mg dvakrat na dan (glejte poglavje 5.2).
Co-administration of dolutegravir and other medicinal products that inhibit these enzymes may increase dolutegravir plasma concentration (see Table 2).
Sočasno jemanje dolutegravirja in drugih zdravil, ki zavirajo te encime, lahko poveča plazemske koncentracije dolutegravirja
In the presence of integrase class resistance alternative combinations that do not include efavirenz should be considered (see section 4.4).
Pri odpornosti na zdravila iz skupine zaviralcev integraze pridejo v poštev alternativne kombinacije, ki ne vključujejo efavirenza (glejte poglavje 4.4).
• For the treatment of HIV that is resistant to other medicines similar to Tivicay, the usual dose of
• Za zdravljenje HIV, ki je odporen na druga zdravila, podobna zdravilu Tivicay, je običajni odmerek zdravila Tivicay ena 50 mg tableta dvakrat na dan.
Tivicay 25 mg and 50 mg film-coated tablets
Tivicay 25 mg in 50 mg filmsko obložene tablete
Treatment emergent resistance in previously untreated patients failing therapy Through 96 weeks in SPRING-2 and FLAMINGO and 144 weeks in SINGLE, no cases of treatment emergent primary resistance to the integrase- or NRTI-class were seen in the dolutegravir-containing arms.
Med zdravljenjem nastala odpornost pri predhodno nezdravljenih bolnikih z neuspešnim zdravljenjem V skupini, v kateri je zdravljenje obsegalo dolutegravir, niso opazili med zdravljenjem nastale primarne odpornosti proti skupini integraz ali NRTI, in sicer v študijah SPRING-2 in FLAMINGO do 96 tednov in v študiji SINGLE do 144 tednov zdravljenja.
At 144 weeks in the openlabel phase of SINGLE, virologic suppression was maintained, the dolutegravir + ABC/3TC arm (71%) was superior to the EFV/TDF/FTC arm (63%), treatment difference was 8.3% (2.0, 14.6).
Skupina, zdravljena s kombinacijo dolutegravir + ABC/3TC (71 %), je bila superiorna skupini, zdravljeni s kombinacijo EFV/TDF/FTC (63 %); razlika med zdravljenjema je bila 8,3 % (2,0; 14,6).
In the presence of integrase class resistance alternative combinations that do not include nevirapine should be considered (see section 4.4).
Pri odpornosti na zdravila iz skupine zaviralcev integraze pridejo v poštev alternativne kombinacije, ki ne vključujejo nevirapina (glejte poglavje 4.4).
Musculoskeletal and connective tissue disorders
Bolezni mišično skeletnega sistema in vezivnega tkiva občasni artralgija občasni mialgija
INFORMATION IN BRAILLE tivicay 50 mg
PODATKI V BRAILLOVI PISAVI tivicay 50 mg
Tivicay 10 mg film-coated tablets Tivicay 25 mg film-coated tablets Tivicay 50 mg film-coated tablets dolutegravir
Tivicay 10 mg filmsko obložene tablete Tivicay 25 mg filmsko obložene tablete Tivicay 50 mg filmsko obložene tablete dolutegravir
At baseline, median patient age was 48 years, 23% were female, 29% non-white, and 20% had hepatitis B and/or C co-infection.
Ob izhodišču je bila mediana starost bolnikov 48 let, 23% je bilo žensk, 29% nebelcev, 20% jih je imelo sočasno okužbo z virusom hepatitisa B
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.
V multicentrični, odprti študiji VIKING-3 (ING112574) je ena skupina odraslih, okuženih z virusom HIV-1, ki so že prejemali ART in so bili brez virološkega odziva ter so bili bodisi takrat ali v preteklosti odporni na raltegravir in/ali elvitegravir, prejemala 50 mg zdravila Tivicay dvakrat na dan, ob trenutno neuspešni osnovni shemi 7 dni, vendar ob optimiziranem osnovnem zdravljenju z ART od 8. dneva dalje.
Atazanavir ↔ Ritonavir ↔ (inhibition of UGT1A1 and CYP3A enzymes)
atazanavir ↔ ritonavir ↔ (zaviranje encimov UGT1A1 in CYP3A)
Dolutegravir ↔ Methadone ↔ AUC ↓ 2% Cmax ↔ 0% Cτ ↓ 1%
Analgetiki metadon dolutegravir ↔ metadon ↔ AUC ↓ 2% Cmax ↔ 0% Cτ ↓ 1%
>200 c/ mm3 By HIV-1 subtype B
>100,000 kopij/mL s CD4+ ≤200 celic/ mm3 >200 celic/ mm3 s HIV-1 podtipom B ne-B
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.
Populacijske farmakokinetične analize kumulativnih farmakokinetičnih podatkov študij faze IIb in III pri odraslih niso pokazale klinično pomembnega vpliva rase na izpostavljenost dolutegravirju.
Dolutegravir belongs to a group of anti-retroviral medicines called integrase inhibitors (INIs).
ki se imenujejo zaviralci integraze (INIs - integrase inhibitors).
If you notice any of these symptoms: → Tell your doctor.
Če opazite katerega od teh simptomov:
Interaction Geometric mean change
Geometrijsko povprečje spremembe (%)
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
vendar pa je čas do pojava teh dogodkov, ki ga navajajo v poročilih, precej različen, saj lahko pride do njih tudi več mesecev po začetku zdravljenja (glejte poglavje 4.4).
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.
Populacijske farmakokinetične analize kumulativnih farmakokinetičnih podatkov študij faze IIb in III pri odraslih niso pokazale klinično pomembnega vpliva spola na izpostavljenost dolutegravirju.
Always take this medicine exactly as your doctor has told you.
Jemljite zdravilo Tivicay tako dolgo, kot vam priporoča zdravnik.
Table 5 Response (<50 cps/ml, snapshot) in GEMINI 1 + 2, pooled data.
Preglednica 5: Združeni podatki odziva (<50 kopij/ml, “snapshot” algoritem) v študijah GEMINI 1 + DTG + 3TC (N=716) n/N (%)
Dolutegravir ↔ AUC ↑ 1% Cmax ↓ 3% Cτ ↓ 8% Tenofovir ↔
Nukleozidni zaviralci reverzne transkriptaze tenofovir dolutegravir ↔ AUC ↑ 1% Cmax ↓ 3% Cτ ↓ 8% tenofovir ↔
All patients adjusted diff -1.7% (CI95-4.4, 1.1) a
Prilagojena razlika -1,7% (IZ 95-4,4, 1,1)a z izhodiščno HIV-1 RNA
The between-subject PK variability of dolutegravir was higher in HIV-infected subjects than healthy subjects.
Interindividualna farmakokinetična variabilnost dolutegravirja je bila pri preiskovancih, okuženih s
Liver chemistry elevations consistent with immune reconstitution syndrome were observed in some subjects with hepatitis B and/or C co-infection at the start of dolutegravir therapy, particularly in those whose anti-hepatitis B therapy was withdrawn (see section 4.4).
sočasno okuženih tudi z virusom hepatitisa B in/ali C, posebej še pri tistih, pri katerih je bila terapija proti hepatitisu B ukinjena (glejte poglavje 4.4).
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).
V študiji SAILING je bila po 48 tednih v skupini, ki je prejemala zdravilo Tivicay (71%), virološka supresija (HIV-1 RNA < 50 kopij/ml) statistično superiorna glede na skupino, ki je prejemala raltegravir (64%) (p=0,03).
The recommended adult dose of dolutegravir is 50 mg twice daily when co-administered with tipranavir/ritonavir.
Priporočeni odmerek dolutegravirja za odrasle je 50 mg dvakrat na dan, kadar se daje skupaj s tipranavirjem/ritonavirjem.
Do not take an antacid during the 6 hours before you take Tivicay, or for at least 2 hours after you take it. Other acid-lowering medicines like ranitidine and omeprazole can be taken at the same time as Tivicay.
V 6 urah pred jemanjem zdravila Tivicay ali vsaj 2 uri po tem, ko ste ga vzeli, ne jemljite kalcijevega ali železovega dodatka ali multivitaminskih pripravkov.
You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
čeprav učinkovito protiretrovirusno zdravljenje to tveganje zmanjša.
What you need to know before you take Tivicay
Kaj morate vedeti, preden boste vzeli zdravilo Tivicay Ne jemljite zdravila Tivicay:
No dose adjustment of oral contraceptives is necessary when co-administered with dolutegravir.
Pri sočasni uporabi z dolutegravirjem prilagajanje odmerka peroralnih kontraceptivov ni potrebno.
No dosage adjustment is considered necessary for patients with renal impairment.
Menijo, da bolnikom z okvaro ledvic odmerka ni treba prilagoditi.
The recommended adult dose of dolutegravir is 50 mg twice daily when co-administered with efavirenz.
Priporočeni odmerek dolutegravirja za odrasle je 50 mg dvakrat na dan, kadar se daje skupaj z efavirenzom.
Antacids, to treat indigestion and heartburn, can stop Tivicay being absorbed into your body and make it less effective.
Tivicay v telo in povzročijo, da je zdravilo manj učinkovito.
Patients should be informed that dizziness has been reported during treatment with dolutegravir.
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Bolnike je treba obvestiti, da so med zdravljenjem z dolutegravirjem poročali o omotici.
Dolutegravir should not be used with etravirine without coadministration of atazanavir/ritonavir, darunavir/ritonavir or lopinavir/ritonavir in INIresistant patients (see further below in table).
Pri pediatričnih bolnikih je treba na podlagi telesne mase določeni dnevni odmerek podvojiti, tako da ga namesto enkrat na dan uporabimo dvakrat na dan. Dolutegravir se ne sme uporabljati z etravirinom brez sočasne uporabe atazanavirja/ritonavirja, darunavirja/ritonavirja ali lopinavirja/ritonavirja pri bolnikih odpornih proti zaviralcem integraze (glejte v preglednici spodaj).
Dolutegravir ↓ AUC ↓ 59% Cmax ↓ 47% Cτ ↓ 76% (induction of UGT1A1 and CYP3A enzymes)
dolutegravir ↓ AUC ↓ 59% Cmax ↓ 47% Cτ ↓ 76% (indukcija encimov UGT1A1 in CYP3A)
• joint pain, stiffness and bone problems You need to know about important signs and symptoms to look out for while you're taking Tivicay.
Pomembne znake in simptome morate poznati, da boste nanje pozorni med tem, ko jemljete zdravilo Tivicay.
Dolutegravir ↓ (Not studied, decrease expected due to induction of UGT1A1 and CYP3A enzymes, a similar reduction in exposure as observed with carbamazepine is expected)
CYP3A), pričakovati je mogoče podobno zmanjšanje izpostavljenosti, kot je ugotovljeno s karbamazepinom).
The recommended adult dose of dolutegravir is 50 mg twice daily when co-administered with nevirapine.
Priporočeni odmerek dolutegravirja za odrasle je 50 mg dvakrat na dan, kadar se daje skupaj z nevirapinom.
Mean increase in CD4+ T cell (cells/mm3) ‡ Adjusted for baseline stratification factors.
Srednja vrednost CD4+ T-celic (celic/mm3)
Magnesium/ aluminium-containing antacid should be taken well separated in time from the administration of dolutegravir (minimum 2 hours after or 6 hours before).
Antacid, ki vsebuje magnezij/aluminij, je treba vzeti s precejšnjim časovnim zamikom (minimalno
No dose adjustment is necessary of either agent.
Pri nobenem od obeh zdravil ni potrebno prilagajanje odmerka.
Dolutegravir 50 mg + ABC/3TC Once Daily N=414
ABC/3TC enkrat na dan N=414
Very common Headache Common Dizziness
Bolezni živčevja zelo pogosti glavobol pogosti omotica
RAL 400 mg Twice Daily + 2 NRTI N=411
+ 2 NRTI N=411
Atazanavir ↔ (historical controls) (inhibition of UGT1A1 and CYP3A enzymes)
atazanavir ↔ (retrospektivne kontrole) (zaviranje encimov UGT1A1 in CYP3A)
Uncommon Hypersensitivity (see section 4.4) Uncommon Immune Reconstitution Syndrome (see section 4.4)** Psychiatric disorders Common Insomnia Common Abnormal dreams
občasni sindrom imunske rekonstitucije (glejte poglavje 4.4)**
The primary endpoint and other week 48 outcomes (including outcomes by key baseline covariates) for SPRING-2 and SINGLE are shown in Table 4.
Primarni cilj in ostali rezultati po 48 tednih (vključno z rezultati po ključnih osnovnih spremenljivkah) študij
Dolutegravir ↓ AUC ↓ 35% Cmax ↓ 24% Cτ ↓ 49% (induction of UGT1A1 and CYP3A enzymes)
dolutegravir ↓ AUC ↓ 35% Cmax ↓ 24% Cτ ↓ 49% (indukcija encimov UGT1A1 in CYP3A)
In a Phase I/II 48 week multicentre, open-label study (P1093/ING112578), the pharmacokinetic parameters, safety, tolerability and efficacy of Tivicay has been evaluated in combination regimens in HIV-1 infected, treatment-experienced, INI naive children and adolescents (6 to less than 18 years of age).
faze so ocenjevali farmakokinetične parametre, varnost, prenašanje in učinkovitost zdravila Tivicay v kombiniranih terapevtskih shemah pri že zdravljenih otrocih in mladostnikih (starih od 6 do manj kot 18 let), okuženih z virusom HIV-1, ki še niso prejemali INI.
The proportion of responders (HIV-1 RNA <50 c/mL) at week 24 was predicted to increase around 4-18% in the subjects with Q148 + ≥2 secondary mutations from G140A/C/S, E138A/K/T, L74I.
Napovedano povečanje deleža odzivnih (HIV-1 RNA < 50 kopij/ml) v 24. tednu je bilo približno 4-18 % pri preiskovancih s Q148 +
Nelfinavir
Odmerek
Rare side effects These may affect up to 1 in 1000 people:
Ti se lahko pojavijo pri največ 1 od 1000 bolnikov:
Dolutegravir did not affect male or female fertility in rats at doses up to 1000 mg/kg/day, the highest dose tested (24 times the 50 mg twice daily human clinical exposure based on AUC).
1000 mg/kg/dan je bil največji testirani odmerek (24-kratnik klinične izpostavljenosti pri človeku med uporabo 50 mg dvakrat na dan, na podlagi AUC).
Package leaflet: Information for the patient
Preglednica 1: Priporočila za odmerjanje pri pediatričnih bolnikih
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).
Pri teh bolnikih je zato priporočljiva previdna uporaba dolutegravirja (glejte poglavje 5.2).
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.
Tivicay 10 mg filmsko obložene tablete so bele, okrogle, bikonveksne tablete z oznako ‘SV 572' na eni in ‘10' na drugi strani.
Subjects were enrolled with a screening plasma HIV-1 RNA of 1000
V raziskavo so bili vključeni preiskovanci s HIV-1 RNA v plazmi med 1000 kopij/mL in ≤500,000 kopij/mL.
Yellow, round, biconvex tablets approximately 9 mm in diameter debossed with ‘SV 572' on one side and ‘50' on the other side.
Rumene, okrogle, bikonveksne tablete premera približno 9 mm, z vtisnjeno oznako ‘SV 572' na eni in ‘50' na drugi strani.
Tivicay 10 mg film-coated tablets
Tivicay 10 mg filmsko obložene tablete
EU/1/13/892/004 EU/1/13/892/005 EU/1/13/892/006
EU/1/13/892/003 EU/1/13/892/004
White, round, biconvex tablets approximately 6 mm in diameter debossed with ‘SV 572' on one side and ‘10' on the other side.
Bele, okrogle, bikonveksne tablete premera približno 6 mm, z vtisnjeno oznako ‘SV 572' na eni in ‘10' na drugi strani.
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.
Preiskovanci so imeli izhodiščno odpornost proti več skupinam antiretrovirusnih zdravil: 80 % je imelo ≥ 2 NRTI, 73 % ≥ 1 NNRTI in 67 % ≥ 2 PI večji mutaciji; 83 % jih je imelo virus ne-R5.
Cmax ↓ 72% (Complex binding to polyvalent ions)
(Tvori kompleks s polivalentnimi ioni)
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.
Tivicay 25 mg filmsko obložene tablete so bledo rumene, okrogle, bikonveksne tablete z oznako ‘SV 572' na eni in ‘25' na drugi strani.
At baseline, median patient age was 49 years, 20% were female, 58% non-white, and 23% had hepatitis B and/or C co-infection.
Izhodiščno je bila mediana starost bolnikov 49 let, 20 % je bilo žensk, 58 % nebelcev in 23 %
Netherlands.
Nizozemska
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.
16% je bilo žensk, 32% nebelcev, 7% jih je imelo sočasno okužbo z virusom hepatitisa C, 4% pa jih je bilo razvrščenih v CDC razred C; te lastnosti so bile pri obeh terapevtskih skupinah podobne.
Do not take a calcium supplement, iron supplement or multivitamin during the 6 hours before you take Tivicay, or for at least 2 hours after you take it (see also Section 3).
Tivicay ali vsaj 2 uri po tem, ko ste ga vzeli, ne jemljite kalcijevega dodatka, železovega dodatka ali multivitaminskega pripravka (glejte tudi poglavje 3).
Pale yellow, round, biconvex tablets approximately 7 mm in diameter debossed with ‘SV 572' on one side and ‘25' on the other side.
Bledo rumene, okrogle, bikonveksne tablete premera približno 7 mm, z vtisnjeno oznako ‘SV 572' na eni in ‘25' na drugi strani.
Tivicay 25 mg film-coated tablets
Tivicay 25 mg filmsko obložene tablete
Rebound up to week 48 b
Virološki odboj po predhodno potrjeni supresiji do 48. tednab
When co-administered with dolutegravir 50mg once daily:
Med sočasno uporabo z dolutegravirjem 50 mg enkrat na dan: metformin
• stiffness in the joints
• nelagodje v želodcu
In vivo, a 10-14% decrease of creatinine clearance (secretory fraction is dependent on OCT2 and MATE-1 transport) was observed in patients.
In vivo so pri bolnikih opazili 10-14% zmanjšanje očistka kreatinina
Antiviral activity in combination with other antiviral agents No antagonistic effects in vitro were seen with dolutegravir and other antiretrovirals tested: stavudine, abacavir, efavirenz, nevirapine, lopinavir, amprenavir, enfuvirtide, maraviroc and raltegravir.
Pri testiranju dolutegravirja in drugih protivirusnih zdravil, kot so stavudin, abakavir, efavirenz, nevirapin,
MARKETING AUTHORISATION NUMBER(S) EU/1/13/892/001
ŠTEVILKA (E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/892/001
Tivicay 50 mg film-coated tablets
Tivicay 50 mg filmsko obložene tablete
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.
Tivicay 50 mg filmsko obložene tablete so rumene, okrogle, bikonveksne tablete, z vtisnjeno oznako ‘SV 572' na eni in ‘50' na drugi strani.
Each film-coated tablet contains dolutegravir sodium equivalent to 10 mg dolutegravir.
Ena filmsko obložena tableta vsebuje 10 mg dolutegravirja (v obliki natrijeve soli).
Dolutegravir ↓ AUC ↓ 22% Cmax ↓ 11% C24 ↓ 38% (induction of UGT1A1 and CYP3A enzymes)
darunavir/ritonavir dolutegravir ↓ AUC ↓ 22% Cmax ↓ 11% C24 ↓ 38% (indukcija encimov UGT1A1 in CYP3A)
Each film-coated tablet contains dolutegravir sodium equivalent to 25 mg dolutegravir.
Ena filmsko obložena tableta vsebuje 25 mg dolutegravirja (v obliki natrijeve soli).
Clade C
CDC.
• a high temperature (fever)
• povišano telesno temperaturo (vročina) • pomanjkanje energije (utrujenost)
MARKETING AUTHORISATION NUMBER(S) EU/1/13/892/005
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/13/892/005
In rabbits, maternal toxicity (decreased food consumption, scant/no faeces/urine, suppressed body weight gain) was observed at 1000 mg/kg (0.40 times the 50 mg twice daily human clinical exposure based on AUC).
zavrto pridobivanje telesne mase) opažali pri 1000 mg/kg (0,40-kratnik klinične izpostavljenosti pri človeku med uporabo 50 mg dvakrat na dan na podlagi AUC).
When co-administered with dolutegravir 50mg twice daily:
Med sočasno uporabo z dolutegravirjem 50 mg dvakrat na dan: metformin
c/mL to ≤500,000 c/mL.
≤ 50.000 kopij/ml > 50.000 kopij/ml
Monitoring of liver biochemistries is recommended in patients with hepatitis B and/or C co-infection.
Pri bolnikih, ki so sočasno okuženi tudi s hepatitisom B in/ali C, je priporočljivo spremljati biokemijske vrednosti jetrnih testov.
In the presence of integrase inhibitor resistance, there are insufficient data to recommend a dose for dolutegravir in adolescents.
Pri prisotni odpornosti na zdravila iz skupine zaviralcev integraze se priporoča jemanje zdravila Tivicay med jedjo, da se poveča izpostavljenost
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).
V mednarodni, multicentrični, dvojno slepi študiji SAILING (ING111762) je bilo 719 odraslih, okuženih z virusom HIV, ki so že prejemali protiretrovirusno terapijo (ART), randomiziranih v skupino, ki je prejemala 50 mg dolutegravirja enkrat na dan, ali v skupino, ki je prejemala 400 mg raltegravirja dvakrat na dan,
Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir.
Ena filmsko obložena tableta vsebuje 50 mg dolutegravirja (v obliki natrijeve soli).
Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 57% C24 ↓ 56% (Complex binding to polyvalent ions)
Železovi dodatki dolutegravir ↓ AUC ↓ 54% Cmax ↓ 57% C24 ↓ 56%
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja pogosti izpuščaj pogosti srbečica