natgillin/translations-raw huggingface dataset:
The IC50 for dolutegravir in various lab-strains using PBMC was 0.5 nM, and when using MT-4 cells it ranged from 0.7-2 nM.
IC50 dolutegravira protiv različitih laboratorijskih sojeva u mononuklearnim stanicama periferne krvi iznosio je 0,5 nM, dok se u MT-4 stanicama kretao u rasponu od 0,7 do 2 nM.
Population PK analyses using pooled pharmacokinetic data from clinical studies where dolutegravir or lamivudine was administered to adults in combination with other ARVs revealed no clinically relevant effect of gender on the exposure of dolutegravir or lamivudine.
Populacijske farmakokinetičke analize objedinjenih farmakokinetičkih podataka iz kliničkih ispitivanja u kojima su se dolutegravir ili lamivudin primjenjivali u kombinaciji s drugim antiretrovirusnim lijekovima u odraslih osoba pokazale su da spol nije imao klinički značajnog učinka na izloženost dolutegraviru ni lamivudinu.
Immune system disorders: Uncommon:
Poremećaji imunološkog sustava: Manje često:
rhabdomyolysis
rabdomioliza
Dolutegravir did not change daclatasvir plasma concentration.
Dolutegravir nije promijenio koncentraciju daklatazvira u plazmi.
There are no data available on the effects of the combination of dolutegravir and lamivudine in animals.
5.3 Neklinički podaci o sigurnosti primjene Nema dostupnih podataka o učincima kombinacije dolutegravira i lamivudina u životinja.
In vitro, lamivudine did not inhibit or induce CYP enzymes (such as CYP3A4, CYP2C9 or CYP2D6) and demonstrated no or weak inhibition of OATP1B1, OAT1B3, OCT3, BCRP, P-gp, MATE1 or MATE2-K. Lamivudine is therefore not expected to affect the plasma concentrations of medicinal products that are substrates of these enzymes or transporters.
In vitro dolutegravir nije bio supstrat ljudskih prijenosnika OATP 1B1, OATP 1B3 ni OCT 1. In vitro lamivudin nije inhibirao ni inducirao CYP enzime (kao što su CYP3A4, CYP2C9 ili CYP2D6) te nije inhibirao ili je slabo inhibirao OATP1B1, OAT1B3, OCT3, BCRP, P-gp, MATE1 ili
No data are available in patients with severe hepatic impairment (Child-Pugh grade C); therefore Dovato should be used with caution in these patients (see section 5.2).
Nema dostupnih podataka o bolesnicima s teškim oštećenjem jetrene funkcije (Child-Pugh stadij C), pa u tih bolesnika
In reproductive toxicity studies in animals, dolutegravir and lamivudine were shown to cross the placenta.
Ispitivanja reproduktivne toksičnosti Ispitivanja reproduktivne toksičnosti na životinjama pokazala su da dolutegravir i lamivudin prolaze kroz posteljicu.
Calcium supplements/Dolutegravir (fasted intake)
nadomjesci kalcija / dolutegravir (kada se uzima natašte)
Dolutegravir ↔ AUC ↑ 7% Cmax ↑ 5% Cτ ↑ 8% Boceprevir ↔ (historical controls)
Druge antivirusne djelatne tvari boceprevir / dolutegravir dolutegravir ↔ AUC ↑ 7% Cmax ↑ 5% Cτ ↑ 8% boceprevir ↔ (kontrole iz prethodnih ispitivanja)
At week 48, dolutegravir plus lamivudine was non-inferior to dolutegravir plus tenofovir disoproxil/emtricitabine FDC in GEMINI-1 and GEMINI-2 studies.
U 48. tjednu ispitivanja GEMINI-1 i GEMINI-2 kombinacija dolutegravira i lamivudina bila je neinferiorna kombinaciji dolutegravira i fiksnih doza tenofovirdizoproksila/emtricitabina.
The apparent volume of distribution of dolutegravir (Vd/F) is 17-20 L. Intravenous studies with lamivudine showed that the mean apparent volume of distribution is 1.3 L/kg.
U ispitivanjima intravenske primjene utvrđeno je da srednja vrijednost prividnog volumena distribucije lamivudina iznosi 1,3 l/kg.
This combination may increase the risk for lactic acidosis in patients with moderate renal impairment (stage 3a creatinine clearance 45- 59 mL/min) and a cautious approach is recommended.
Ta kombinacija može povećati rizik od laktacidoze u bolesnika s umjerenim oštećenjem bubrežne funkcije (stadij 3a, klirens kreatinina:
Dolutegravir ↔ AUC ↑ 12% Cmax ↑ 13% Cτ ↑ 22% Rilpivirine ↔
rilpivirin / dolutegravir dolutegravir ↔ AUC ↑ 12% Cmax ↑ 13% Cτ ↑ 22% rilpivirin ↔
: + 33 (0)1 39 17 69 69 Infomed@viivhealthcare.com
ViiV Healthcare SAS Tél.: + 33 (0)1 39 17 69 69 Infomed@viivhealthcare.com
Table 1:
(vidjeti Tablicu 1).
Dolutegravir ↓ (Not studied, a similar reduction in exposure as observed with efavirenz is expected, due to induction)
nevirapin / dolutegravir dolutegravir ↓ (Interakcija se nije ispitivala; zbog indukcije se očekuje smanjenje izloženosti slično onome opaženome kod primjene efavirenza.)
† Based on CMH-stratified analysis adjusting for the following baseline stratification factors: Plasma HIV-1 RNA (≤100,000 c/mL vs. >100,000 c/mL) and CD4+ cell count (≤200 cells/mm3 vs. >200 cells/mm3).
† Na temelju analize stratificirane Cochran-Mantel-Haenszelovom metodom i prilagođene za sljedeće početne stratifikacijske faktore: plazmatsku koncentraciju HIV-1 RNK (≤ 100 000 kopija/ml naspram
No drug interaction studies have been conducted using Dovato.
Nisu provedena ispitivanja interakcija između lijeka Dovato i drugih lijekova.
Dolutegravir ↔ No dosage adjustment necessary.
Inhibitori protonske pumpe omeprazol dolutegravir ↔ Nije potrebno prilagođavati dozu.
Dolutegravir ↓ (Not studied, decrease expected due to induction of UGT1A1 and CYP3A enzymes, a similar reduction in exposure as observed with carbamazepine is expected).
Biljni lijekovi gospina trava / dolutegravir dolutegravir ↓ (Interakcija se nije ispitivala; očekuje se smanjenje koncentracija zbog indukcije enzima UGT1A1 i CYP3A te smanjenje izloženosti slično onome opaženome kod primjene karbamazepina.)
nausea, diarrhoea
mučnina, proljev
• if you have a kidney problem.
• ako imate bubrežnih tegoba
Renal impairment Pharmacokinetic data have been obtained for dolutegravir and lamivudine separately.
Prikupljeni su farmakokinetički podaci za dolutegravir i lamivudin kao zasebne djelatne tvari.
Daclatasvir did not change dolutegravir plasma concentration to a clinically relevant extent.
Daklatazvir nije doveo do klinički značajne promjene koncentracije dolutegravira u plazmi.
Studies in patients with renal impairment show lamivudine elimination is affected by renal dysfunction.
Ispitivanja u bolesnika s oštećenjem bubrežne funkcije pokazuju da bubrežna disfunkcija utječe na eliminaciju lamivudina.
The combination of Dovato with cladribine is not recommended (see section 4.5).
Ne preporučuje se primjena lijeka Dovato u kombinaciji s kladribinom (vidjeti dio 4.5).
MARKETING AUTHORISATION NUMBER(S) EU/1/19/1370/002
EU/1/19/1370/001 EU/1/19/1370/002
Dovato should not be taken with any other medicinal product containing dolutegravir or lamivudine, except where a dose adjustment of dolutegravir is indicated due to drug-drug interactions (see section 4.5).
Dovato se ne smije uzimati ni s jednim drugim lijekom koji sadrži dolutegravir ili lamivudin, osim u slučajevima kada je zbog interakcija s drugim lijekovima potrebno prilagoditi dozu dolutegravira
Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 57% C24 ↓ 56% (Complex binding to polyvalent ions)
dolutegravir ↓ AUC ↓ 54% Cmax ↓ 57% C24 ↓ 56% (stvaranje kompleksa s polivalentnim ionima)
Antacid medicines
Antiretrovirusni lijekovi
Dolutegravir ↓ AUC ↓ 39% Cmax ↓ 37% C24 ↓ 39% (Complex binding to polyvalent ions)
dolutegravir ↓ AUC ↓ 39% Cmax ↓ 37% C24 ↓ 39% (stvaranje kompleksa s polivalentnim ionima)
Population PK analyses using pooled pharmacokinetic data from clinical studies where dolutegravir was administered to adults in combination with other ARVs revealed no clinically relevant effect of race on the exposure of dolutegravir.
Populacijske farmakokinetičke analize objedinjenih farmakokinetičkih podataka iz kliničkih ispitivanja u kojima se dolutegravir primjenjivao u kombinaciji s drugim antiretrovirusnim lijekovima u odraslih osoba pokazale su da rasa nije imala klinički značajnog učinka na izloženost dolutegraviru.
Uncommon side effects that may show up in blood tests are:
Manje česte nuspojave koje se mogu vidjeti u nalazima krvnih pretraga:
General disorders and administration site conditions: Common:
Opći poremećaji i reakcije na mjestu primjene: Često:
Dolutegravir ↔ AUC ↑ 11% Cmax ↑ 6% Cτ ↑ 17%
Kortikosteroidi prednizon / dolutegravir dolutegravir ↔ AUC ↑ 11% Cmax ↑ 6% Cτ ↑ 17%
Dovato 50 mg/300 mg film-coated tablets dolutegravir/lamivudine
Dovato 50 mg/300 mg tablete dolutegravir/lamivudin
Dolutegravir ↓ AUC ↓ 33% Cmax ↓ 35% C24 ↓ 32% (Complex binding to polyvalent ions)
dolutegravir ↓ AUC ↓ 33% Cmax ↓ 35% C24 ↓ 32% (stvaranje kompleksa s polivalentnim ionima)
Drug interactions
Interakcija
Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir and 300 mg lamivudine.
Jedna filmom obložena tableta sadrži 50 mg dolutegravira u obliku dolutegravirnatrija i 300 mg lamivudina.
Tel: + 34 902 051 260 es-ci@viivhealthcare.com
Laboratorios ViiV Healthcare, S.L. Tel: + 34 902 051 260 es-ci@viivhealthcare.com
Each tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir and 300 mg lamivudine.
Jedna tableta sadrži 50 mg dolutegravira u obliku dolutegravirnatrija i 300 mg lamivudina.
How to store Dovato
Moguće nuspojave Kako čuvati Dovato
If you take Dovato with food, you can take supplements or multivitamins containing calcium, iron or magnesium at the same time as Dovato.
Ako Dovato uzimate s hranom, možete istodobno uzeti i dodatke prehrani ili multivitaminske pripravke koji sadrže kalcij, željezo ili magnezij.
The clinical status of the patient and the adverse reaction profile of Dovato should be borne in mind when considering the patient's ability to drive or operate machinery.
Kada se razmatra bolesnikova sposobnost upravljanja vozilima ili rada sa strojevima, u obzir treba uzeti kliničko stanje bolesnika i profil nuspojava lijeka Dovato.
The primary efficacy endpoint for each GEMINI trial was the proportion of subjects with plasma HIV-1 RNA <50 copies/mL at Week 48 (Snapshot algorithm for the ITT-E population).
Primarna mjera ishoda za djelotvornost u ispitivanjima GEMINI bio je udio ispitanika kojima je plazmatska koncentracija HIV-1 RNK u 48. tjednu iznosila < 50 kopija/ml (algoritam za globalnu snimku distribuiranog sustava [engl. snapshot algorithm] za populaciju bolesnika predviđenih za liječenje koji su primili najmanje jednu dozu ispitivanog lijeka [engl. intent-to-treat exposed, ITT-E]).
1 This adverse reaction was identified through post-marketing surveillance for dolutegravir in combination with other ARVs.
Ova je nuspojava utvrđena tijekom praćenja sigurnosti dolutegravira u kombinaciji s drugim antiretroviroticima nakon stavljanja u promet.
• stomach (abdominal) pain or discomfort
• bol ili nelagoda u trbuhu (abdomenu)
Lamivudine exhibits linear pharmacokinetics over the therapeutic dose range and displays limited plasma protein binding in vitro (< 16%- 36% to serum albumin).
Lamivudin pokazuje linearnu farmakokinetiku u rasponu terapijskih doza te se u ograničenoj mjeri veže za proteine u plazmi in vitro
• stiffness in the joints
• bol u zglobovima
• breakdown of muscle tissue.
• upala gušterače (pankreatitis) • razgradnja mišićnog tkiva
NAME OF THE MEDICINAL PRODUCT Dovato 50 mg/300 mg film-coated tablets
Dovato 50 mg/300 mg filmom obložene tablete
Dolutegravir was shown to cross the placenta in animals.
Pokazalo se da dolutegravir prolazi kroz posteljicu u životinja.
No dose adjustment is required in patients with mild renal impairment.
Nije potrebno prilagođavati dozu u bolesnika s blagim oštećenjem bubrežne funkcije.
Proton pump inhibitors Omeprazole
Dolutegravir je inhibitor
Dolutegravir ↔ AUC ↓ 4% Cmax ↔ 0% C24 ↓ 6%
lopinavir + ritonavir / dolutegravir dolutegravir ↔ AUC ↓ 4% Cmax ↔ 0% C24 ↓ 6%
peripheral neuropathy, paraesthesia Gastrointestinal disorders:
periferna neuropatija, parestezija
Dolutegravir ↔ AUC ↑ 11% Cmax ↑ 7% Cτ ↑ 28%
lopinavir + ritonavir + etravirin / dolutegravir dolutegravir ↔ AUC ↑ 11% Cmax ↑ 7% Cτ ↑ 28%
Name and address of the manufacturer(s) responsible for batch release
PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet
Musculoskeletal and connective tissue disorders: Common:
angioedem Poremećaji mišićno-koštanog sustava i vezivnog tkiva:
Discontinued for lack of efficacy
Prekid sudjelovanja u ispitivanju zbog drugih razloga
Common:
Pretrage:
Lopinavir ↔ Ritonavir ↔ Etravirine ↔
lopinavir ↔ ritonavir ↔ etravirin ↔
The apparent oral clearance (CL/F) is approximately 1 L/hr in HIV-infected patients based on a population pharmacokinetic analysis.
Na temelju populacijske farmakokinetičke analize utvrđeno je da prividni klirens nakon peroralne primjene (CL/F) u bolesnika s HIV infekcijom iznosi približno 1 l/h.
Joint pain, stiffness and bone problems
Bol i ukočenost u zglobovima, tegobe s kostima
Dolutegravir ↓ AUC ↓ 57% Cmax ↓ 39% Cτ ↓ 75%
efavirenz / dolutegravir dolutegravir ↓ AUC ↓ 57% Cmax ↓ 39% Cτ ↓ 75%
Atazanavir ↔ (historical controls) (inhibition of UGT1A1 and CYP3A enzymes)
atazanavir ↔ (kontrole iz prethodnih ispitivanja) (inhibicija enzima UGT1A1 i CYP3A)
When administered in fasted state, bioequivalence was achieved for lamivudine AUC, when comparing Dovato to lamivudine 300 mg co-administered with dolutegravir 50 mg. Lamivudine Cmax for Dovato was 32% higher than lamivudine 300 mg co-administered with dolutegravir 50 mg.
Kod primjene natašte postignuta je bioekvivalentnost s obzirom na AUC lamivudina između lijeka Dovato i lamivudina u dozi od 300 mg primijenjenog istodobno s dolutegravirom u dozi od 50 mg.
Very rare side effects that may show up in blood tests are: • a failure of the bone marrow to produce new red blood cells (pure red cell aplasia).
• nemogućnost koštane srži da proizvede nove crvene krvne stanice (izolirana aplazija crvenih krvnih stanica)
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 (37.2 times the 50 mg human clinical exposure, based on AUC following single dose in the fasted state).
6. do 17. dana gestacije nije uzrokovala toksičnost za majku, razvojnu toksičnost ni teratogenost (izloženost 37,2 puta veća od kliničke izloženosti u ljudi kod primjene doze od 50 mg, što je utvrđeno na temelju AUC-a nakon primjene jednokratne doze natašte).
Effect of dolutegravir: EE ↔ AUC ↑ 3% Cmax ↓ 1%
EE ↔ AUC ↑ 3% Cmax ↓ 1%
Dolutegravir↓ AUC ↓ 35% Cmax ↓ 24% Cτ ↓ 49%
fosamprenavir + ritonavir / dolutegravir dolutegravir ↓ AUC ↓ 35% Cmax ↓ 24% Cτ ↓ 49%
Dolutegravir ↓ AUC ↓ 22% Cmax ↓ 11% Cτ ↓ 38%
darunavir + ritonavir / dolutegravir dolutegravir ↓ AUC ↓ 22% Cmax ↓ 11% Cτ ↓ 38%
PHARMACEUTICAL FORM AND CONTENTS 30 tablets
30 tableta
Lamivudine is cleared renally.
Lamivudin se izlučuje putem bubrega.
An increase in weight and in levels of blood lipids and glucose may occur during antiretroviral therapy.
Tijekom antiretrovirusne terapije može doći do povećanja tjelesne težine te povišenja razine lipida i glukoze u krvi.
Darunavir ↔ Ritonavir ↔ Etravirine ↔
darunavir ↔ ritonavir ↔ etravirin ↔
NAME OF THE MEDICINAL PRODUCT Dovato 50 mg/300 mg film-coated tablets dolutegravir/lamivudine
Dovato 50 mg/300 mg filmom obložene tablete dolutegravir/lamivudin
Etravirine ↔ (induction of UGT1A1 and CYP3A enzymes)
etravirin ↔ (indukcija enzima UGT1A1 i CYP3A)
Dolutegravir ↓ AUC ↓ 25% Cmax ↓ 12% Cτ ↓ 36%
darunavir + ritonavir + etravirin / dolutegravir dolutegravir ↓ AUC ↓ 25% Cmax ↓ 12% Cτ ↓ 36%
Efavirenz ↔ (historical controls) (induction of UGT1A1 and CYP3A enzymes)
efavirenz ↔ (kontrole iz prethodnih ispitivanja) (indukcija enzima UGT1A1 i CYP3A)
Vistor hf.
Prijenos HIV-a
Dolutegravir ↓ AUC ↓ 59% Cmax ↓ 47% Cτ ↓ 76%
tipranavir + ritonavir / dolutegravir dolutegravir ↓ AUC ↓ 59% Cmax ↓ 47% Cτ ↓ 76%
Tipranavir ↔ Ritonavir ↔ (induction of UGT1A1 and CYP3A enzymes)
tipranavir ↔ ritonavir ↔ (indukcija enzima UGT1A1 i CYP3A)
Tel: + 385 16051 999
GlaxoSmithKline d.o.o. Tel: + 385 16051 999
Dolutegravir ↓ AUC ↓ 49% Cmax ↓ 33% Cτ ↓ 73%
Antikonvulzivi karbamazepin / dolutegravir dolutegravir ↓ AUC ↓ 49% Cmax ↓ 33% Cτ ↓ 73%
The recommended dose of dolutegravir is 50 mg twice daily for patients taking etravirine without boosted protease inhibitors.
Za bolesnike koji uzimaju etravirin bez pojačanih inhibitora proteaze preporučena doza dolutegravira iznosi 50 mg dvaput na dan.
No dosage adjustment is considered necessary for patients with mild to moderate hepatic impairment.
Ne smatra se potrebnim prilagođavati dozu u bolesnika s blagim do umjerenim oštećenjem jetrene funkcije Utjecaj teškog oštećenja jetrene funkcije na farmakokinetiku dolutegravira nije se ispitivao.
Discontinued for other reasons and ≥50 copies/mL
Prekid liječenja zbog nedostatne djelotvornosti Prekid liječenja zbog drugih razloga dok je vrijednost bila ≥ 50 kopija/ml
Fosamprenavir↔ Ritonavir ↔ (induction of UGT1A1 and CYP3A enzymes)
fosamprenavir↔ ritonavir ↔ (indukcija enzima UGT1A1 i CYP3A)
Hypersensitivity reactions have been reported with dolutegravir, and were characterized by rash, constitutional findings, and sometimes, organ dysfunction, including severe liver reactions.
sustavnim simptomima te ponekad poremećajem funkcije organa, uključujući teške jetrene reakcije.
When administered in fasted state, bioequivalence regarding Cmax was achieved for dolutegravir, when comparing Dovato to dolutegravir 50 mg co-administered with lamivudine 300 mg. Dolutegravir AUC0-t was 16% higher for Dovato than for dolutegravir 50 mg co-administered with lamivudine 300 mg.
Kod primjene natašte postignuta je bioekvivalentnost s obzirom na Cmax dolutegravira između lijeka Dovato i dolutegravira u dozi od 50 mg primijenjenog istodobno s lamivudinom u dozi od 300 mg.
Liver chemistry elevations consistent with immune reconstitution syndrome were observed in some hepatitis B and/or C co-infected patients at the start of dolutegravir therapy.
U nekih bolesnika s istodobnom infekcijom virusom hepatitisa B i/ili C su na početku liječenja dolutegravirom primijećena povišenja vrijednosti biokemijskih parametara jetrene funkcije koja odgovaraju sindromu imunološke rekonstitucije.
Monitoring of liver chemistries is recommended in patients with hepatitis B and/or C co-infection.
U bolesnika s istodobnom infekcijom virusom hepatitisa B i/ili C preporučuje se praćenje biokemijskih parametara jetrene funkcije (vidjeti odlomak
The recommended dose of dolutegravir is 50 mg twice daily when co-administered with nevirapine.
Kod istodobne primjene s nevirapinom preporučena doza dolutegravira iznosi 50 mg dvaput na dan.
The recommended dose of dolutegravir is 50 mg twice daily when co-administered with rifampicin.
Kod istodobne primjene s rifampicinom preporučena doza dolutegravira iznosi 50 mg dvaput na dan.
Dolutegravir
Učinak dolutegravira:
Table 3
PRILOG III.
Metformin ↑ Dolutegravir ↔ When co-administered with dolutegravir 50 mg QD:
Antidijabetici metformin / dolutegravir metformin ↑ dolutegravir ↔ Kad se primjenjuje istodobno s dolutegravirom u dozi od 50 mg jedanput na dan: metformin
Antacids and supplements
OBLIK I SADRŽAJ
Consider more frequent monitoring of HIV-1 viral load when chronic coadministration cannot be avoided.
Ako se dugotrajna istodobna primjena tih lijekova ne može izbjeći, potrebno je razmotriti češće praćenje količine virusa HIV-1 u krvi.
Miscellaneous
Antacidi
• muscle or joint aches.
• bolovi u mišićima ili zglobovima
fatigue
Nuspojava
Cmax ↑ 16% Cτ ↓ 30% (induction of UGT1A1 and CYP3A enzymes)
rifabutin / dolutegravir dolutegravir ↔ AUC ↓ 5% Cmax ↑ 16% Cτ ↓ 30% (indukcija enzima UGT1A1 i CYP3A)
As Dovato is a fixed-dose tablet, an additional 50 mg tablet of dolutegravir should be administered, approximately 12 hours after Dovato for the duration of the tipranavir/ritonavir co-administration (a separate formulation of dolutegravir is available for this dose adjustment, see section 4.2).
Budući da je Dovato tableta s fiksnom kombinacijom doza, tijekom cijelog razdoblja istodobnog liječenja tipranavirom/ritonavirom potrebno je uzimati dodatnu tabletu dolutegravira od 50 mg, približno 12 sati nakon lijeka Dovato (za tu je prilagodbu doze dostupna zasebna formulacija dolutegravira, vidjeti dio 4.2).
→ Talk to your doctor for further advice on taking acid-lowering medicines with Dovato.
→ Za dodatne savjete o uzimanju lijeka Dovato zajedno s lijekovima koji smanjuju količinu kiseline u želucu razgovarajte sa svojim liječnikom.
Elderly
ranitidin
A separate preparation of dolutegravir is available where a dose adjustment is indicated due to drug-drug interactions (e.g. rifampicin, carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St. John's wort, etravirine (without boosted protease inhibitors), efavirenz, nevirapine, or tipranavir/ritonavir, see sections 4.4 and 4.5).
Dostupna je zasebna formulacija dolutegravira za slučajeve kada je potrebna prilagodba doze zbog interakcija s drugim lijekovima (npr. rifampicinom, karbamazepinom, okskarbazepinom, fenitoinom,
Sorbitol
laktacidoza
When co-administered with dolutegravir 50 mg BID:
Kad se primjenjuje istodobno s dolutegravirom u dozi od 50 mg dvaput na dan:
The recommended dose of dolutegravir is 50 mg twice daily when co-administered with efavirenz.
Kod istodobne primjene s efavirenzom preporučena doza dolutegravira iznosi 50 mg dvaput na dan.
PHARMACEUTICAL FORM AND CONTENTS 30 tablets.
30 tableta.
The recommended dose of dolutegravir is 50 mg twice daily when co-administered with these metabolic inducers.
Nakon primjene dolutegravira u dozi od 50 mg jedanput na dan u odraslih ispitanika s HIV-1
As Dovato is a fixed-dose tablet, an additional 50 mg tablet of dolutegravir should be administered, approximately 12 hours after Dovato for the duration of the rifampicin co-administration (a separate formulation of dolutegravir is available for this dose adjustment, see section 4.2).
Dovato tableta s fiksnom kombinacijom doza, tijekom cijelog razdoblja istodobnog liječenja rifampicinom potrebno je uzimati dodatnu tabletu dolutegravira od 50 mg, približno 12 sati nakon lijeka Dovato (za tu je prilagodbu doze dostupna zasebna formulacija dolutegravira, vidjeti dio 4.2).
As Dovato is a fixed-dose tablet, an additional 50 mg tablet of dolutegravir should be administered, approximately 12 hours after Dovato for the duration of the etravirine without boosted protease inhibitor co-administration (a separate formulation of dolutegravir is available for this dose adjustment, see section
Budući da je Dovato tableta s fiksnom kombinacijom doza, tijekom cijelog razdoblja istodobnog liječenja etravirinom bez pojačanih inhibitora proteaze potrebno je uzimati dodatnu tabletu dolutegravira od 50 mg, približno 12 sati nakon lijeka Dovato (za tu je prilagodbu doze dostupna zasebna formulacija dolutegravira, vidjeti dio 4.2).
As Dovato is a fixed-dose tablet, an additional 50 mg tablet of dolutegravir should be administered, approximately 12 hours after Dovato for the duration of the efavirenz co-administration (a separate formulation of dolutegravir is available for this dose adjustment, see section 4.2).
Dovato tableta s fiksnom kombinacijom doza, tijekom cijelog razdoblja istodobnog liječenje efavirenzom potrebno je uzimati dodatnu tabletu dolutegravira od 50 mg, približno 12 sati nakon lijeka Dovato (za tu je prilagodbu doze dostupna zasebna formulacija dolutegravira, vidjeti dio 4.2).
Dolutegravir ↔ AUC ↑ 1% Cmax ↓ 3% Cτ ↓ 8% Tenofovir ↔
Nukleozidni inhibitori reverzne transkriptaze (engl. nucleoside reverse transcriptase inhibitor, NRTI) tenofovirdizoproksil emtricitabin, didanozin, stavudin, tenofoviralafenamid, zidovudin dolutegravir ↔ AUC ↑ 1% Cmax ↓ 3% Cτ ↓ 8% tenofovir ↔
Do not take an antacid during the 6 hours before you take Dovato, or for at least 2 hours after you take it. You can take other acid-lowering medicines like ranitidine and omeprazole at the same time as Dovato.
Nemojte uzimati antacid unutar 6 sati prije primjene lijeka Dovato ni najmanje 2 sata nakon njegove primjene.