natgillin/translations-raw huggingface dataset:
Abacavir hypersensitivity reactions Even patients who don't have the HLA-B*5701 gene may still develop a hypersensitivity reaction (a serious allergic reaction).
Čak i u bolesnika koji nemaju gen HLA-B*5701 može se razviti reakcija preosjetljivosti (ozbiljna alergijska reakcija).
Symptoms related to this HSR worsen with continued therapy and can be life-threatening and in rare instance, have been fatal.
Simptomi povezani s tom reakcijom preosjetljivosti pogoršavaju se s nastavkom liječenja i mogu ugroziti život, a u rijetkim su slučajevima imali smrtni ishod.
Drug Interactions Medicinal products by therapeutic areas
Lijekovi prema terapijskim područjima
There are no data on the effects of dolutegravir, abacavir or lamivudine on human male or female fertility.
Nema podataka o učincima dolutegravira, abakavira ili lamivudina na plodnost muškaraca ili žena.
1This adverse reaction was identified from clinical studies or post-marketing experience for dolutegravir, abacavir or lamivudine when used with other antiretrovirals or postmarketing experience with Triumeq.
1Ova nuspojava utvrđena je u kliničkim ispitivanjima ili nakon stavljanja lijeka u promet dolutegravira, abakavira ili lamivudina kada su se primjenjivali s drugim antiretroviroticima ili nakon stavljanja u promet lijeka Triumeq.
Tabulated summary of adverse reactions associated with the combination of dolutegravir + abacavir/lamivudine in an analysis of pooled data from: Phase IIb to Phase IIIb clinical trials or post-marketing experience; and adverse reactions to treatment with dolutegravir, abacavir and lamivudine from clinical studies and post-marketing experience when used with other antiretrovirals
Tablica 2: Tablični sažetak nuspojava povezanih s liječenjem kombinacijom dolutegravir + abakavir/lamivudin u analizi objedinjenih podataka iz kliničkih ispitivanja faze IIb do faze IIIb ili nakon stavljanja u promet, te nuspojava na liječenje dolutegravirom, abakavirom i lamivudinom u kliničkim ispitivanjima i nakon stavljanja u promet, kada su se primjenjivali s drugim antiretroviroticima.
Hypersensitivity reactions have been reported in <1% of patients treated with dolutegravir in clinical studies, and were characterized by rash, constitutional findings, and sometimes, organ dysfunction, including severe liver reactions.
<1% bolesnika liječenih dolutegravirom u kliničkim ispitivanjima prijavljene su reakcije preosjetljivosti koje su se manifestirale osipom, općim simptomima te ponekad poremećajem funkcije organa, uključujući teške jetrene reakcije.
If the doctor thinks they may be related to a hypersensitivity reaction, you will be told never again to take Triumeq, or any other medicine containing abacavir or dolutegravir.
Ako liječnik misli da bi mogli biti povezani s reakcijom preosjetljivosti, reći će Vam da nikada više ne smijete uzimati Triumeq niti druge lijekove koji sadrže abakavir ili dolutegravir.
Both abacavir and dolutegravir are associated with a risk for hypersensitivity reactions (HSR) (see section 4.8), and share some common features such as fever and/or rash with other symptoms indicating multi-organ involvement.
Reakcije preosjetljivosti (vidjeti dio 4.8) I abakavir i dolutegravir povezuju se s rizikom od reakcija preosjetljivosti (vidjeti dio 4.8) te dijele neke zajedničke značajke, poput vrućice i/ili osipa praćenih drugim simptomima koji upućuju na zahvaćenost većeg broja organa.
As well as the side effects listed below for Triumeq, other conditions can develop during combination therapy for HIV.
Osim nuspojava na Triumeq navedenih u nastavku, tijekom primjene kombinirane terapije za HIV mogu se razviti i druga stanja.
Lamivudine exhibits linear pharmacokinetics over the therapeutic dose range and displays low plasma protein binding (less than 36%).
Lamivudin pokazuje linearnu farmakokinetiku u cijelom rasponu terapijskih doza te se u maloj mjeri veže za proteine u plazmi (manje od 36%).
The effect of severe hepatic impairment on the pharmacokinetics of dolutegravir has not been studied.
Učinak teškog oštećenja jetrene funkcije na farmakokinetiku dolutegravira nije ispitivan.
Malignant tumours occurred in the preputial gland of males and the clitoral gland of females of both species, and in rats in the thyroid gland of males and in the liver, urinary bladder, lymph nodes and the subcutis of females.
Maligni su se tumori kod obje vrste javljali na prepucijskoj žlijezdi u mužjaka i klitoralnoj žlijezdi u ženki, dok su se u štakora javljali i na štitnoj žlijezdi mužjaka te u jetri, mokraćnom mjehuru, limfnim čvorovima i potkožnom tkivu ženki.
Ethanol/Abacavir (0.7 g/kg single dose/600mg single dose)
Alkohol etanol/dolutegravir etanol/lamivudin etanol/abakavir (0,7 g/kg u jednokratnoj dozi/600 mg u jednokratnoj dozi)
Retinoid compounds (e.g. Isotretinoin)
Retinoidi retinoidni spojevi (npr. izotretinoin)
Hepatitis B co-infection was one of main exclusion criteria.
Jedan od glavnih isključnih kriterija bila je istodobna infekcija virusom hepatitis B.
The mean IC50 against lab-strains of HIV-2 (LAV2 and EHO) ranged from 1.57 to 7.5 µM for abacavir and from 0.16 to 0.51 µM for lamivudine.
Srednja vrijednost IC50 za laboratorijske sojeve HIV-2 (LAV2 i EHO) kretala se u rasponu od 1,57 do 7,5 µM za abakavir te od 0,16 do 0,51 µM za lamivudin.
coadministration of Triumeq with medicinal products containing sorbitol or other osmotic acting poly-alcohols or monosaccharide alcohols (eg: xylitol, mannitol, lactitol, maltitol).
Kada je moguće, izbjegavajte dugotrajnu istodobnu primjenu lijeka Triumeq i lijekova koji sadrže sorbitol ili neki drugi polialkohol ili monosaharidni alkohol s osmotskim djelovanjem (npr. ksilitol, manitol, laktitol, maltitol).
In FLAMINGO, 485 patients were treated with dolutegravir 50 mg once daily or darunavir/ritonavir (DRV/r) 800 mg/100 mg once daily, both with ABC/3TC (around 33%) or TDF/FTC (around 67%).
U ispitivanju FLAMINGO, 485 bolesnika liječeno je ili dolutegravirom u dozi od 50 mg jedanput na dan ili darunavirom/ritonavirom (DRV/r) u dozi od 800 mg/100 mg jedanput na dan; oba su se režima primjenjivala u kombinaciji s ABC/3TC (približno 33%) ili TDF/FTC (približno 67%).
For lamivudine, the IC50 values against HIV-1 subtypes (A-G) ranged from 0.001 to 0.170 µM, against Group O from 0.030 to 0.160 µM and against HIV-2 isolates from 0.002 to 0.120 µM in peripheral blood mononuclear cells.
Vrijednosti IC50 lamivudina za HIV-1 podvrste (A-G) kretale su se u rasponu od 0,001 do 0,170 µM, za skupinu O u rasponu od 0,030 do 0,160 µM, a za izolate HIV-2 u rasponu od 0,002 do 0,120 µM u mononuklearnim stanicama periferne krvi.
Group O isolates from antiviral naïve patients tested for lamivudine activity were highly sensitive.
Izolati skupine O prikupljeni u bolesnika koji nisu liječeni antiviroticima pokazali su se visoko osjetljivima na djelovanje lamivudina.
Do not take an antacid during the 6 hours before you take Triumeq, or for at least 2 hours after you take it. (See also Section 3).
Ne smijete uzeti antacid unutar 6 sati prije primjene lijeka Triumeq niti još najmanje 2 sata nakon njegove primjene (pogledajte i dio 3.)
Dolutegravir ↑ AUC ↑ 62% Cmax ↑ 34% Cτ ↑ 121%
atazanavir+ ritonavir/ dolutegravir dolutegravir ↑ AUC ↑ 62% Cmax ↑ 34% Cτ ↑ 121%
Lamivudine: AUC ↑43% Cmax ↑7%
AUC ↑43% Cmax ↑7%
RAL 400mg twice daily + 2 NRTI N=411
RAL 400 mg dvaput na dan + 2 NRTI N=411
Dolutegravir ↑ AUC ↑ 91% Cmax ↑ 50% Cτ ↑ 180%
Inhibitori proteaze atazanavir/dolutegravir dolutegravir ↑ AUC ↑ 91% Cmax ↑ 50% Cτ ↑ 180%
There is no evidence that a dose adjustment of dolutegravir, abacavir or lamivudine would be required based on the effects of race on PK parameters.
Nema dokaza da bi bilo potrebno prilagoditi dozu dolutegravira, abakavira ili lamivudina na temelju učinaka rase na farmakokinetičke parametre.
Interactions between dolutegravir, abacavir, lamivudine and co-administered medical products are listed in Table 1 (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, area under the concentration versus time curve as “AUC”, maximum observed concentration as “Cmax”).
Interakcije između dolutegravira, abakavira, lamivudina i istodobno primijenjenih lijekova navedene su u Tablici 1 (povećanje je označeno kao “↑”, smanjenje kao “↓”, stanje bez promjene kao “↔”,
The terminal intracellular half-life of lamivudine-TP was prolonged to 16-19 hours, compared to the plasma lamivudine half-life of 5-7 hours, supporting once daily dosing of ABC and 3TC.
16-19 sati, dok je poluvijek lamivudina u plazmi iznosio 5-7 sati, što omogućuje doziranje ABC-a i 3TC-a jedanput na dan.
Dolutegravir, abacavir and lamivudine are rapidly absorbed following oral administration.
Dolutegravir, abakavir i lamivudin se nakon peroralne primjene brzo apsorbiraju.
You should have been tested for this gene before Triumeq was prescribed for you.
Liječnik je trebao napraviti pretragu kako bi utvrdio imate li taj gen prije nego što Vam je propisao Triumeq.
Triumeq can make you dizzy and have other side effects that make you less alert.
Triumeq može uzrokovati omaglicu i druge nuspojave koje mogu umanjiti Vašu sposobnost reagiranja.
In SINGLE, 833 patients were treated with dolutegravir 50 mg once daily plus fixed-dose abacavirlamivudine (DTG + ABC/3TC) or fixed-dose efavirenz-tenofovir-emtricitabine (EFV/TDF/FTC).
U ispitivanju SINGLE, 833 bolesnika liječena su ili dolutegravirom u dozi od 50 mg jedanput na dan u kombinaciji s fiksnom dozom abakavira-lamivudina (DTG + ABC/3TC) ili fiksnom dozom efavirenza-tenofovira-emtricitabina (EFV/TDF/FTC).
The adverse reactions considered at least possibly related to treatment with the components of Triumeq from clinical study and post-marketing experience are listed in Table 2 by body system, organ class and absolute frequency.
Tablični prikaz nuspojava Nuspojave prijavljene u kliničkim ispitivanjima i nakon stavljanja lijeka u promet, čija se povezanost sa sastavnicama lijeka Triumeq smatra barem mogućom, navedene su u Tablici 2 prema klasifikaciji organskih sustava i apsolutnoj učestalosti.
Abacavir is primarily metabolised by the liver with approximately 2% of the administered dose being renally excreted, as unchanged compound.
Abakavir se primarno metabolizira u jetri, a približno 2% primijenjene doze izlučuje se kroz bubrege u nepromijenjenu obliku.
Lamivudine monotherapy is generally not considered an adequate treatment for hepatitis B, since the risk for hepatitis B resistance development is high.
Zbog visokog rizika od razvoja rezistencije hepatitisa B, monoterapija lamivudinom obično se ne smatra prikladnim liječenjem za hepatitis B.
- Restarting abacavir containing products following a suspected abacavir HSR can result in a prompt return of symptoms within hours.
- Ponovno uvođenje lijekova koji sadrže abakavir nakon suspektne reakcije preosjetljivosti na abakavir može dovesti do brzog povratka simptoma unutar svega nekoliko sati.
Increases in serum creatinine occurred within the first week of treatment with dolutegravir and remained stable through 96 weeks.
Povećanja koncentracije kreatinina u serumu nastupila su u prvome tjednu liječenja dolutegravirom,
Virologic suppression (HIV-1 RNA <50 copies/mL) in the ABC/DTG/3TC FDC group (85%) was statistically non-inferior to the current ART groups (88%) at 24 weeks.
Virusna supresija (HIV-1 RNK < 50 kopija/ml) u 24. tjednu u skupini koja je primala fiksnu kombinaciju ABC/DTG/3TC (85%) bila je neinferiorna onoj u skupinama koje su nastavile primati dotadašnju antiretrovirusnu terapiju (88%).
ABC HSR educational material for health care professionals
• Edukacijske materijale o reakcijama preosjetljivosti na abakavir za zdravstvene radnike
There is no evidence that a dose adjustment of dolutegravir, abacavir or lamivudine would be required based on the effects of gender on PK parameters.
Nema dokaza da bi bilo potrebno prilagoditi dozu dolutegravira, abakavira ili lamivudina na temelju učinaka spola na farmakokinetičke parametre.
In vitro, dolutegravir inhibited the renal transporters OCT2 and MATE1.
Dolutegravir je in vitro inhibirao bubrežne prijenosnike OCT2 i MATE1.
No Triumeq dosage adjustment necessary, unless patient has renal impairment (See Section 4.2).
Triumeq, osim ako bolesnik nema oštećenje bubrežne funkcije (vidjeti dio 4.2).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE CARTON (INDIVIDUAL PACKS ONLY)
KUTIJA ZA BOCU (SAMO POJEDINAČNA PAKIRANJA)
Each pack of 30 film-coated tablets contains a desiccant.
Jedno pakiranje s 30 filmom obloženih tableta sadrži sredstvo za sušenje.
• difficulty in sleeping (insomnia)
• tegobe sa spavanjem (nesanica) • nedostatak energije (umor)
Virologic non response† No virologic data at Weeks 48 window Reasons Discontinued study/study drug due to adverse event or death‡ Discontinued study/study drug for other reasons§ Missing data during window but on study HIV-1 RNA <50copies/mL for those on ABC/3TC Median time to viral suppression**
Izostanak virološkog odgovora† Nema viroloških podataka unutar 48 tjedana Razlozi Prekid sudjelovanja u ispitivanju/primjene ispitivanog lijeka zbog nuspojave ili smrti‡ Prekid sudjelovanja u ispitivanju/primjene ispitivanog lijeka zbog drugih razloga§ HIV-1 RNK < 50 kopija/ml u bolesnika koji primaju ABC/3TC
In SPRING-2, 822 patients were treated with either dolutegravir 50 mg once daily or raltegravir 400 mg twice daily (blinded), both with fixed-dose ABC/3TC (around 40%) or TDF/FTC (around 60%), given open label.
U ispitivanju SPRING-2, 822 bolesnika liječena su ili dolutegravirom u dozi od 50 mg jedanput na dan ili raltegravirom u dozi od 400 mg dvaput na dan (slijepo liječenje); oba su se lijeka primjenjivala u kombinaciji s fiksnom dozom ABC/3TC (približno 40%) ili TDF/FTC (približno 60%), koja se davala otvoreno.
vomiting, flatulence, abdominal pain, abdominal pain upper, abdominal distension, abdominal discomfort, gastrooesophageal reflux disease, dyspepsia
povraćanje, flatulencija, bol u abdomenu, bol u gornjem dijelu abdomena, distenzija abdomena, nelagoda u abdomenu, gastroezofagealna refluksna bolest, dispepsija rijetko:
HIV-1 RNA <50 copies/mL Treatment Difference*
HIV-1 RNK <50 kopija/ml
Since the recommended dose of dolutegravir is 50 mg twice daily for patients with resistance to integrase inhibitors, the use of Triumeq is not recommended for patients with integrase inhibitor resistance.
Budući da preporučena doza dolutegravira za bolesnike s rezistencijom na inhibitore integraze iznosi 50 mg dvaput na dan, primjena lijeka Triumeq ne preporučuje se u bolesnika s rezistencijom na inhibitore integraze.
You must carefully read all the information under ‘Hypersensitivity reactions' in the panel in Section 4.
Morate pažljivo pročitati sve informacije u odlomku 'Reakcije preosjetljivosti' u dijelu 4.
In vitro, dolutegravir inhibited the renal uptake organic anion transporters (OAT)1 and OAT3.
In vitro je dolutegravir inhibirao bubrežne prijenosnike za unos organskih aniona OAT1 i OAT3.
The symptoms related to this HSR worsen with continued therapy and can be lifethreatening.
Simptomi povezani s tom reakcijom preosjetljivosti pogoršavaju se s nastavkom terapije i mogu ugroziti život.
R263K was reported from two individual patients with subtype B and subtype C in the clinical program for ART experienced, INI naive subjects, but without effects on dolutegravir susceptibility in vitro.
kliničkom je programu mutacija R263K prijavljena u dva bolesnika s podvrstom B i podvrstom C koji su prethodno primali antiretrovirotike, ali ne i inhibitore integraze, no ona nije utjecala na osjetljivost na dolutegravir in vitro.
PHARMACEUTICAL FORM AND CONTENTS Multipack: 90 (3 packs of 30) film-coated tablets
Višestruko pakiranje: 90 (3 pakiranja s 30) filmom obloženih tableta
In rabbits, maternal toxicity (decreased food consumption, scant/no faeces/urine, suppressed body weight gain) was observed at 1000 mg/kg (0.74 times the 50 mg human clinical exposure when administered in combination with abacavir and lamivudine based on AUC).
U kunića je toksičnost za majku (smanjen unos hrane, slabo izlučivanje/izostanak izlučivanja fecesa/mokraće, suprimiran prirast tjelesne težine) primijećena pri primjeni doze od 1000 mg/kg (izloženost 0,74 puta veća od kliničke izloženosti u ljudi pri primjeni doze od 50 mg u kombinaciji s abakavirom i lamivudinom, što je utvrđeno na temelju
Dolutegravir is also a substrate of UGT1A3, UGT1A9, CYP3A4, Pglycoprotein (P-gp), and breast cancer resistance protein (BCRP).
Dolutegravir se uglavnom eliminira metabolizmom u kojem posreduje uridindifosfat glukuronoziltransferaza (UGT) 1A1. Dolutegravir je i supstrat za UGT1A3, UGT1A9, CYP3A4, P-glikoprotein (P-gp) te protein rezistencije raka dojke (engl. breast cancer resistance protein, BCRP).
Dolutegravir ↓ (Not studied, a similar reduction in exposure as observed with efavirenz is expected, due to induction)
nevirapin/dolutegravir dolutegravir ↓ (nije ispitivano, zbog indukcije se očekuje smanjenje izloženosti slično onome kod primjene efavirenza)
Abacavir is primarily metabolised by the liver with approximately 2% of abacavir excreted unchanged in the urine.
Abakavir se prvenstveno metabolizira u jetri, a približno 2% abakavira izlučuje se kroz mokraću u nepromijenjenu obliku.
• rifampicin, to treat tuberculosis (TB) and other bacterial infections
• kladribin, koji se koristi za liječenje leukemije vlasastih stanica • rifampicin, koji se koristi za liječenje tuberkuloze (TBC) i drugih bakterijskih infekcija
In vitro, abacavir did not inhibit or induce CYP enzymes (such as CYP3A4, CYP2C9 or CYP2D6) and demonstrates no or weak inhibition of OATP1B1, OAT1B3, OCT1, OCT2, BCRP and P-gp or
In vitro, abakavir nije inhibirao ni inducirao CYP enzime (kao što su CYP3A4, CYP2C9 ili CYP2D6) te nije inhibirao ili je slabo inhibirao OATP1B1, OAT1B3, OCT1, OCT2, BCRP i P-gp ili MATE2-K.
Abacavir is metabolised by UGT (UGT2B7) and alcohol dehydrogenase; co-administration of inducers (e.g. rifampicin, carbamazepine and phenytoin) or inhibitors (e.g. valproic acid) of UGT enzymes or with compounds eliminated through alcohol dehydrogenase could alter abacavir exposure.
Abakavir se metabolizira posredstvom UGT-a (UGT2B7) i alkohol-dehidrogenaze; istodobna primjena induktora (npr. rifampicina, karbamazepina i fenitoina) ili inhibitora (npr. valproatne kiseline)
In HIV-infected patients with severe immune deficiency at the time of initiation of CART, an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
U bolesnika s HIV infekcijom i teškom imunodeficijencijom u trenutku uvođenja kombinirane antiretrovirusne terapije može se razviti upalna reakcija na asimptomatske ili rezidualne oportunističke infekcije.
Lamivudine is also substrate of the hepatic uptake transporter OCT1.
Lamivudin je i supstrat prijenosnika za unos tvari u jetru OCT1.
Triumeq should not be used in patients who are known to carry the HLA-B*5701 gene.
Triumeq ne smiju uzimati bolesnici za koje se zna da su nositelji gena HLA-B*5701.
Mitochondrial dysfunction Nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage.
Pokazalo se da nukleozidni i nukleotidni analozi uzrokuju različite stupnjeve mitohondrijskog oštećenja in vitro i in vivo.
• St. John's wort (Hypericum perforatum), a herbal remedy to treat depression
• gospinu travu (Hypericum perforatum), biljni lijek za liječenje depresije • metadon, koji se koristi kao nadomjesna terapija za heroin.
Similar IC50s were seen for clinical isolates without any major difference between subtypes; in a panel of 24 HIV-1 isolates of clades A, B, C, D, E, F and G and group O the mean IC50 value was 0.2 nM (range 0.02-2.14).
viđene su i kod kliničkih izolata, bez većih razlika među podvrstama; na paleti od 24 izolata HIV-1 iz linija A, B, C, D, E, F i G te skupine
The pharmacokinetic properties of dolutegravir, lamivudine and abacavir are described below.
Farmakokinetičke značajke dolutegravira, lamivudina i abakavira opisane su u nastavku.
Uncommon side effects that may show up in blood tests are:
Rijetke nuspojave koje se mogu vidjeti u nalazima krvnih pretraga:
Table 6: Demographics and Week 48 virologic outcomes of randomized treatment of ARIA (snapshot algorithm)
Tablica 6: Demografske značajke i virološki ishodi u 48. tjednu randomiziranog liječenja u ispitivanju ARIA (snapshot algoritam)
Dolutegravir ↔ (Not studied)
nelfinavir/dolutegravir dolutegravir ↔ (nije ispitivano)
Late Switch ABC/DTG/3TC FDC N=244 n (%)
Kasni prelazak na fiksnu kombinaciju ABC/DTG/3TC N=244 n (%)
Hypersensitivity case studies
Prikaz slučajeva preosjetljivosti
DTG 50 mg once daily + 2 NRTI N=411
DTG 50 mg jedanput na dan + 2 NRTI N=411
No specific symptoms or signs have been identified following acute overdose with dolutegravir, abacavir or lamivudine, apart from those listed as adverse reactions.
Nakon akutnog predoziranja dolutegravirom, abakavirom ili lamivudinom nisu primijećeni nikakvi posebni simptomi ni znakovi, osim onih koji su navedeni kao nuspojave.
• Shortness of breath, sore throat or cough
• nedostatak zraka, grlobolja ili kašalj
Rarely, patients who have stopped abacavir for reasons other than symptoms of HSR have also experienced life-threatening reactions within hours of re- initiating abacavir therapy (see Section 4.8 Description of selected adverse reactions).
U rijetkim su slučajevima po život opasne reakcije zabilježene unutar svega nekoliko sati nakon ponovnog uvođenja abakavira u bolesnika koji su liječenje abakavirom prekinuli zbog drugih razloga, a ne zbog simptoma reakcija preosjetljivosti (vidjeti dio 4.8, Opis odabranih nuspojava).
General disorders and administration site conditions: Very common:
Opći poremećaji i reakcije na mjestu primjene: vrlo često:
• stomach (abdominal) pain
• nelagoda u trbuhu (abdomenu)
IMPORTANT - Hypersensitivity reactions
Upozorenja i mjere opreza VAŽNO - Reakcije preosjetljivosti
Hypersensitivity reactions have been observed more commonly with abacavir, some of which have been life-threatening, and in rare cases fatal, when not managed appropriately.
Neke od njih bile su opasne po život, a u rijetkim su slučajevima imale i smrtni ishod ako nisu bile adekvatno zbrinute.
Do not take supplements or multivitamins containing calcium, iron or magnesium during the 6 hours before you take Triumeq, or for at least 2 hours after you take it.
Ne smijete uzeti nadomjeske ili multivitaminske pripravke koji sadrže kalcij, željezo ili magnezij unutar 6 sati prije primjene lijeka Triumeq niti još najmanje 2 sata nakon njegove primjene.
Lamivudine is predominately cleared by renal excretion of unchanged lamivudine.
Lamivudin se najvećim dijelom uklanja izlučivanjem putem bubrega u nepromijenjenu obliku.
M184V mutants display greatly reduced susceptibility to lamivudine and show diminished viral replicative capacity in vitro.
pokazuju uvelike smanjenu osjetljivost na lamivudin i smanjenu sposobnost virusne replikacije in vitro.
Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 43% Cτ ↓ 72% (induction of UGT1A1 and CYP3A enzymes)
Antimikobakterijski lijekovi rifampicin/dolutegravir dolutegravir ↓ AUC ↓ 54% Cmax ↓ 43% Cτ ↓ 72% (indukcija enzima UGT1A1 i CYP3A)
Co-administration of Triumeq and other medicinal products that inhibit UGT1A1, UGT1A3, UGT1A9, CYP3A4, and/or P-gp may therefore increase dolutegravir plasma concentration.
UGT1A9, CYP3A4 i/ili P-gp stoga može povećati koncentracije dolutegravira u plazmi.
Population pharmacokinetic analysis of dolutegravir using data in HIV-1 infected adults showed that there was no clinically relevant effect of age on dolutegravir exposure.
Populacijska farmakokinetička analiza dolutegravira na temelju podataka prikupljenih u odraslih osoba s HIV-1 infekcijom pokazala je da dob nije imala klinički značajan učinak na izloženost dolutegraviru.
Supplements or multivitamins containing calcium, iron or magnesium should be taken well separated in time from the administration of Triumeq (minimum 2 hours after or 6 hours before).
Nadomjeske ili multivitaminske pripravke koji sadrže kalcij, željezo ili magnezij treba uzimati s većim vremenskim odmakom u odnosu na primjenu lijeka Triumeq (najmanje 2 sata nakon ili 6 sati prije).
• breakdown of muscle tissue
• upala gušterače (pankreatitis) • razgradnja mišićnog tkiva