natgillin/translations-raw huggingface dataset:
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 (see also Section 3).
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 (pogledajte i dio 3.)
Abacavir has a weak potential to cause chromosomal damage both in vitro and in vivo at high tested concentrations.
Ispitivanja su pokazala da visoke koncentracije abakavira imaju slab potencijal da izazovu kromosomska oštećenja in vitro i in vivo.
Antiviral activity in combination with other antiviral agents No antagonistic effects in vitro were seen with dolutegravir and other antiretrovirals (tested agents: stavudine, abacavir, efavirenz, nevirapine, lopinavir, amprenavir, enfuvirtide, maraviroc, adefovir and raltegravir).
Nisu primijećeni antagonistički učinci in vitro kod primjene dolutegravira i drugih antivirotika (ispitivani lijekovi: stavudin, abakavir, efavirenz, nevirapin, lopinavir, amprenavir, enfuvirtid,
Dolutegravir ↓ AUC ↓ 39% Cmax ↓ 37% C24 ↓ 39% (Complex binding to polyvalent ions)
nadomjesci kalcija/dolutegravir dolutegravir ↓ AUC ↓ 39% Cmax ↓ 37% C24 ↓ 39% (stvaranje kompleksa s polivalentnim ionima)
13.4 g)/Lamivudine oral solution 300 mg Lamivudine:
Jednokratna doza oralne otopine lamivudina od 300 mg lamivudin:
Nevirapine/Dolutegravir
lamivudin i dolutegravir.
Moderate amount of data (more than 600 outcomes from first trimester) indicates no malformative toxicity for abacavir.
Umjerena količina podataka o primjeni abakavira (više od 600 ishoda nakon izloženosti u prvom tromjesečju trudnoće) ne ukazuje na malformacijsku toksičnost.
• indigestion
• omamljenost
Similar levels of virologic suppression were maintained in both the Early and Late Switch groups at 48 weeks.
Virusna supresija u 48. tjednu održala se na sličnoj razini i u skupini koja je rano prešla na fiksnu kombinaciju i u onoj koja prešla kasnije.
HIV-1 RNA <50 copies/mL for those on ABC/3TC * Adjusted for baseline stratification factors.
HIV-1 RNK <50 kopija/ml u bolesnika koji primaju ABC/3TC Medijan vremena do virusne supresije**
• a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling in more than
• rasprostranjen osip praćen mjehurićima i ljuštenjem kože, osobito oko usta, nosa, očiju i genitalija
In ARIA (ING117172), a randomized, open-label, active-controlled, multicenter, parallel group, noninferiority study; 499 HIV-1 infected ART naïve adult women were randomized 1:1 to receive either; DTG/ABC/3TC FDC 50 mg/600 mg/300 mg; or atazanavir 300 mg plus ritonavir 100 mg plus tenofovir disproxil / emtricitabine 245 mg/200 mg (ATV+RTV+TDF/FTC FDC), all administered once daily.
HIV-1 infekcijom koje prethodno nisu primale antiretrovirusnu terapiju bilo je randomizirano u omjeru 1:1 za primanje fiksne kombinacije DTG/ABC/3TC u dozi od 50 mg/600 mg/300 mg ili za primanje atazanavira u dozi od 300 mg plus ritonavira u dozi od 100 mg plus fiksne kombinacije tenofovirdizoproksila/emtricitabina u dozi od 245 mg/200 mg (ATV+RTV+ fiksna kombinacija TDF/FTC); svi ti lijekovi primjenjivali su se jedanput na dan.
Demographics Median Age (years) Female Non-white Hepatitis B and/ or C CDC class C Week 48 Efficacy Results HIV-1 RNA <50 copies/mL Treatment difference
Demografske značajke medijan dobi (godine) žene ispitanici koji nisu bijelci hepatitis B i/ili C kategorija C prema CDC klasifikaciji osnovno liječenje kombinacijom ABC/3TC
Dolutegravir, abacavir and lamivudine have been shown to inhibit replication of lab-strains and clinical isolates of HIV in a number of cell types, including transformed T cell lines, monocyte/macrophage derived lines and primary cultures of activated peripheral blood mononuclear cells (PMBCs) and monocyte/macrophages.
T-limfocita, stanične linije nastale od monocita/makrofaga te primarne kulture aktiviranih mononuklearnih stanica periferne krvi i monocita/makrofaga.
Table 4: Demographics and virologic outcomes of randomized treatment of SPRING-2 (snapshot algorithm)
Tablica 4: Demografske značajke i virološki ishodi randomiziranog liječenja u ispitivanju SPRING-2
Following a single dose of 600 mg of abacavir, the mean (CV) Cmax is 4.26 µg/ml (28%) and the mean (CV)
Nakon jednokratne doze abakavira od 600 mg, srednja vrijednost (CV) Cmax iznosi 4,26 µg/ml (28%), a srednja vrijednost (CV) AUC∞ 11,95 µg.h/ml (21%).
NAME OF THE MEDICINAL PRODUCT Triumeq 50 mg/600 mg/300 mg film-coated tablets
Triumeq 50 mg/600 mg/300 mg filmom obložene tablete
Mild myocardial degeneration in the heart of mice and rats was observed following administration of abacavir for two years.
Nakon dvogodišnje primjene abakavira primijećena je blaga degeneracija miokarda u srcima miševa i štakora.
MARKETING AUTHORISATION NUMBER(S) EU/1/14/940/002
EU/1/14/940/001 EU/1/14/940/002
Iron supplements/Dolutegravir Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 57% C24 ↓ 56% (Complex binding to polyvalent ions)
nadomjesci željeza/dolutegravir dolutegravir ↓ AUC ↓ 54% Cmax ↓ 57% C24 ↓ 56% (stvaranje kompleksa s polivalentnim ionima)
dizziness, somnolence, lethargy1
omaglica, somnolencija, letargija1
Non-white
Rasa bijelci
DTG/ABC/3TC FDC N=248
Fiksna kombinacija DTG/ABC/3TC N=248
The risk for abacavir HSR to occur is high for patients who test positive for the HLA-B*5701 allele.
Rizik od pojave reakcija preosjetljivosti na abakavir je visok u bolesnika s pozitivnim nalazom na alel HLA-B*5701.
Other common symptoms are: nausea (feeling sick), vomiting (being sick), diarrhoea, abdominal (stomach) pain, severe tiredness.
Drugi česti simptomi su: mučnina, povraćanje, proljev, bol u trbuhu, izrazit umor.
Triumeq includes lamivudine, which is active against hepatitis B. Abacavir and dolutegravir lack such activity.
Triumeq sadrži lamivudin, koji djeluje protiv hepatitisa B.
Dolutegravir is highly bound (> 99%) to human plasma proteins based on in vitro data.
Podaci in vitro pokazuju da se dolutegravir u visokom stupnju (> 99%) veže za proteine u plazmi ljudi.
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 za dolutegravir u različitim laboratorijskim sojevima na mononuklearnim stanicama periferne krvi iznosio je 0,5 nM, a na MT-4 stanicama kretao se u rasponu od 0,7-2 nM. Slične vrijednosti IC50
The clinical status of the patient and the adverse reaction profile of Triumeq 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, na umu treba imati kliničko stanje bolesnika i profil nuspojava lijeka Triumeq.
Since the recommended dose of dolutegravir is 50 mg twice daily when co-administered with etravirine (without boosted protease inhibitors), efavirenz, nevirapine, rifampicin, tipranavir/ritonavir, carbamazepine, phenytoin, phenobarbital and St. John's wort, the use of Triumeq is not recommended for patients taking these medicines (see section 4.5).
Budući da pri istodobnoj primjeni s etravirinom (bez pojačanih inhibitora proteaze), efavirenzom, nevirapinom, rifampicinom, tipranavirom/ritonavirom, karbamazepinom, fenitoinom, fenobarbitalom i gospinom travom, preporučena doza dolutegravira iznosi 50 mg dvaput na dan, primjena lijeka
Abacavir should not be used in patients known to carry the HLA-B*5701 allele.
Abakavir se ne smije primjenjivati u bolesnika za koje se zna da su nositelji alela HLA-B*5701.
Reproductive toxicology
Antiretrovirusni lijekovi
These may affect up to 1 in 1000 people:
Rijetke nuspojave Mogu se javiti u do 1 na 1000 osoba:
AUC ↓ 32%
abakavir AUC ↓ 32%
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.
Populacijska farmakokinetička analiza objedinjenih farmakokinetičkih podataka iz ispitivanja faze IIb i faze III u odraslih bolesnika nije ukazala na klinički značajan učinak rase na izloženost dolutegraviru.
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).
međutim, prijavljeno vrijeme do njihova nastupa je različito pa se ti događaji mogu javiti i mjesecima nakon uvođenja liječenja (vidjeti dio 4.4).
• lactic acidosis (excess lactic acid in the blood).
površine tijela (toksična epidermalna nekroliza) • laktacidoza (nakupljanje mliječne kiseline u krvi).
Studies in patients with renal impairment show lamivudine elimination is affected by renal dysfunction.
Ispitivanja u bolesnika s oštećenjem bubrežne funkcije pokazuju da poremećaj funkcije bubrega utječe na eliminaciju lamivudina.
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.
Populacijska farmakokinetička analiza objedinjenih farmakokinetičkih podataka iz ispitivanja faze IIb i faze III u odraslih bolesnika nije ukazala na klinički značajan učinak spola na izloženost dolutegraviru.
The observed values of the peak concentrations are 9-fold greater than the IC50 of abacavir of 0.08 µg/ml or 0.26 µM when abacavir is given at 600 mg twice daily.
abakavira od 0,08 µg/ml ili 0,26 µM nakon primjene doze abakavira od 600 mg dvaput na dan.
While the total dolutegravir concentration in plasma was similar, a 1.5 to 2-fold increase in unbound exposure to dolutegravir was observed in subjects with moderate hepatic impairment compared to healthy controls.
Iako je ukupna koncentracija dolutegravira u plazmi bila podjednaka, u ispitanika s umjerenim oštećenjem jetre izloženost nevezanom dolutegraviru bila
The pharmacokinetics of dolutegravir in 10 antiretroviral treatment-experienced HIV-1 infected adolescents (12 to 17 years) showed that dolutegravir 50 mg once daily dosage resulted in dolutegravir exposure comparable to that observed in adults who received dolutegravir 50 mg once daily.
koji su prethodno liječeni antiretroviroticima, pokazala je da primjena dolutegravira u dozi od 50 mg jedanput na dan dovodi do izloženosti dolutegraviru usporedive s onom primijećenom u odraslih bolesnika koji su primali dolutegravir u dozi od 50 mg jedanput na dan.
Abacavir is primarily metabolised by the liver.
Abakavir se prvenstveno metabolizira u jetri.
• if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection, don't stop Triumeq without your doctor's advice, as your hepatitis may come back)
• ako imate umjerenu ili tešku bolest jetre • ako ste nekada imali bolest jetre, uključujući hepatitis B ili C (ako imate infekciju hepatitisom B,
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 hepatitisom B i/ili C, u skladu sa sindromom imunološke rekonstitucije, primijećena su povišenja biokemijskih pokazatelja jetrene funkcije na početku liječenja dolutegravirom.
Since the recommended dose of dolutegravir is 50 mg twice daily when co-administered with tipranavir/ritonavir, the coadministration of tipranavir/ritonavir with Triumeq is not recommended.
Budući da preporučena doza dolutegravira pri istodobnoj primjeni s tipranavirom/ritonavirom iznosi 50 mg dvaput na dan, ne preporučuje se istodobna primjena tipranavira/ritonavira i lijeka Triumeq.
Hypersensitivity reactions (see section 4.8)
sindrom imunološke rekonstitucije (vidjeti dio 4.4)
- After stopping treatment with Triumeq for reasons of a suspected HSR, Triumeq or any other medicinal product containing abacavir or dolutegravir must never be re-initiated.
Nakon prekida liječenja lijekom Triumeq zbog suspektne reakcije preosjetljivosti, nikada se ne smije ponovno započeti liječenje lijekom Triumeq niti bilo kojim drugim lijekom koji sadrži abakavir ili dolutegravir.
Early Switch ABC/DTG/3TC FDC N=275 n (%)
Rani prelazak na fiksnu kombinaciju ABC/DTG/3TC N=275 n (%)
In 100% human serum, the mean fold shift for dolutegravir activity was 75-fold, resulting in protein adjusted IC90 of 0.064 ug/mL.
puta, što je za posljedicu imalo vrijednost IC90 prilagođenu za proteine od 0,064 μg/ml.
• numbness, tingly feelings in the skin (pins and needles)
• utrnulost, trnci na koži (mravinjanje)
Since the recommended dose of dolutegravir is 50 mg twice daily when co-administered with carbamazepine, DTG/ABC/3TC FDC is not recommended for patients taking carbamazepine.
S obzirom da je preporučena doza dolutegravira 50 mg dvaput na dan kad se istodobno primjenjuje s karbamazepinom, fiksna kombinacija dolutegravir/abakavir/lamivudin se ne preporučuje u bolesnika koji uzimaju karbamazepin.
- Triumeq should never be initiated in patients with a positive HLA-B*5701 status, nor in patients with a negative HLA-B*5701 status who had a suspected abacavir HSR on a previous abacavircontaining regimen.
statusom, niti u bolesnika s negativnim HLA-B*5701 statusom za koje se sumnja da su imali reakciju preosjetljivosti na abakavir tijekom prethodnog liječenja režimom koji je sadržavao abakavir.
The apparent volume of distribution of dolutegravir (following oral administration of suspension formulation, Vd/F) is estimated at 12.5 L. Intravenous studies with abacavir and lamivudine showed that the mean apparent volume of distribution is 0.8 and 1.3 l/kg respectively.
U ispitivanjima intravenske primjene abakavira i lamivudina utvrđeno je da srednja vrijednost prividnog volumena distribucije iznosi 0,8 l/kg odnosno 1,3 l/kg.
Virologically suppressed (HIV-1 RNA <50 c/mL) subjects were randomly assigned (1:1) to continue their current ART regimen (2 NRTIs plus either a PI, NNRTI, or INI), or switch to ABC/DTG/3TC FDC once daily (Early Switch).
Ispitanici s virusnom supresijom (HIV-1 RNK < 50 kopija/ml) bili su randomizirani (1:1) za nastavak dotadašnje antiretrovirusne terapije (2 NRTI-ja plus IP, NNRTI ili inhibitor integraze [INI]) ili za prelazak na fiksnu kombinaciju
Renal impairment Triumeq is not recommended for use in patients with a creatinine clearance < 50 ml/min (see section
Ne preporučuje se primjena lijeka Triumeq u bolesnika s klirensom kreatinina < 50 ml/min (vidjeti dio 5.2).
Cmax ↑ 5% Cτ ↑ 8% Boceprevir ↔ (historical controls)
Ostali antivirotici boceprevir dolutegravir ↔ AUC ↑ 7% Cmax ↑ 5% Cτ ↑ 8% boceprevir ↔ (kontrole iz prethodnih ispitivanja)
Since the dose of dolutegravir is 50 mg twice daily when co-administered with efavirenz, the co-administration of efavirenz with Triumeq is not recommended (see section 4.4).
50 mg dvaput na dan, ne preporučuje se istodobna primjena efavirenza i lijeka Triumeq (vidjeti dio 4.4).
Package leaflet: Information for the patient Triumeq 50 mg/600 mg/300 mg film-coated tablets dolutegravir/abacavir/lamivudine
Uputa o lijeku: Informacije za bolesnika Triumeq 50 mg/600 mg/300 mg filmom obložene tablete dolutegravir/abakavir/lamivudin
Baseline CD4+ (cells/ mm3)
(stanice/mm3)
In serial passage with strain NL432-based site directed mutants at N155H or E92Q, no further selection of resistance was seen (fold change unchanged around 1).
ili E92Q, nije primijećena daljnja selekcija rezistencije (vrijednost promjene od približno 1 ostala je nepromijenjena).
Co-administration with nevirapine may decrease dolutegravir plasma concentration due to enzyme induction and has not been studied.
Istodobna primjena s nevirapinom nije ispitivana, ali bi zbog indukcije enzima mogla smanjiti koncentraciju dolutegravira u plazmi.
For patients co-infected with hepatitis B who are being treated with a lamivudine containing medicinal product such as Triumeq and subsequently become pregnant, consideration should be given to the possibility of a recurrence of hepatitis on discontinuation of lamivudine.
poput lijeka Triumeq, i u međuvremenu zatrudne, mora se razmotriti mogućnost recidiva hepatitisa nakon prekida liječenja lamivudinom.
In HIV-1-infected adult subjects following dolutegravir 50 mg once daily, the steady-state pharmacokinetic parameters (geometric mean [%CV]) based on population pharmacokinetic analyses were AUC(0-24) = 53.6 (27) µg.h/mL, Cmax = 3.67 (20) µg/mL, and Cmin = 1.11 (46) µg/mL.
AUC(0-24) = 53,6 (27) µg.h/ml, Cmax = 3,67 (20) µg/ml i Cmin = 1,11 (46) µg/ml.
You should never take abacavir or abacavircontaining products again if you have a hypersensitivity reaction: it can be life threatening.
Ako razvijete reakciju preosjetljivosti ne smijete više nikada uzimati abakavir ili lijekove koji sadrže abakavir: to može ugroziti život.
Dolutegravir ↔ AUC ↑ 11% Cmax ↑ 7% Cτ ↑ 28%
lopinavir+ritonavir+etravirin/ dolutegravir dolutegravir ↔ AUC ↑ 11% Cmax ↑ 7% Cτ ↑ 28%
Renal impairment Pharmacokinetic data have been obtained for dolutegravir, lamivudine and abacavir separately.
Oštećenje bubrežne funkcije Prikupljeni su farmakokinetički podaci za dolutegravir, lamivudin i abakavir kao zasebne djelatne tvari.
There are no data available on the effects of the combination of dolutegravir, abacavir and lamivudine in animals, except a negative in vivo rat micronucleus test which tested the effects of the combination of abacavir and lamivudine.
osim negativnog nalaza mikronukleusnog testa provedenog na štakorima in vivo, kojim su se ispitivali učinci kombinacije abakavira i lamivudina.
Joint pain, stiffness and bone problems
Bol u zglobovima, ukočenost i tegobe s kostima
Uncommon suicidal ideation or suicide attempt (particularly in patients with a pre-existing history of depression or psychiatric illness)
neuobičajeni snovi, depresija, anksioznost1, noćne more, poremećaj spavanja manje često suicidalne ideje ili pokušaj suicida (osobito u bolesnika s depresijom ili psihijatrijskom bolesti u anamnezi)
Since the dose of dolutegravir is 50 mg twice daily when coadministered with nevirapine, the coadministration of nevirapine with Triumeq is not recommended.
Budući da doza dolutegravira pri istodobnoj primjeni s nevirapinom iznosi 50 mg dvaput na dan, ne preporučuje se istodobna primjena nevirapina i lijeka Triumeq.
hypertriglyceridaemia, hyperglycaemia
manje često hipertrigliceridemija, hiperglikemija vrlo rijetko laktacidoza1
→ Talk to your doctor for further advice on taking antacid medicines with Triumeq.
Obratite se svom liječniku za dodatne savjete o uzimanju lijekova koji smanjuju količinu kiseline u želucu zajedno s lijekom Triumeq.
Since the dose of dolutegravir is 50 mg twice daily when co-administered with rifampicin, the co-administration of rifampicin with Triumeq is not recommended.
Budući da doza dolutegravira pri istodobnoj primjeni s rifampicinom iznosi 50 mg dvaput na dan, ne preporučuje se istodobna primjena rifampicina i lijeka Triumeq.
Treatment with Triumeq must be stopped without delay if HSR cannot be ruled out on clinical grounds, and therapy with Triumeq or other abacavir or dolutegravir containing products must never be re-initiated.
Ako se klinički ne može isključiti reakcija preosjetljivosti, primjena lijeka Triumeq mora se bez odlaganja obustaviti te se više nikada ne smije ponovno započeti liječenje lijekom Triumeq ili drugim lijekovima koji sadrže abakavir ili dolutegravir.
AUC ↔ Cmax ↓35% Methadone: CL/F ↑22%
metadon: CL/F ↑22%
Diagnosis of Abacavir Hypersensitivity Reaction Major symptoms associated with ABC HSR are fever (~80%), rash (~70%), gastrointestinal symptoms (>50%) such as nausea, abdominal pain, vomiting, and diarrhoea, generalise malaise, fatigue, and headache (~50%) and other symptoms (~30%) such as respiratory, mucosal, and musculoskeletal symptoms.
opće malaksalosti, umor i glavobolja (~50%) te drugi simptomi (~30%), poput respiratornih simptoma, simptoma na sluznicama i mišićno-koštanih simptoma.
Film-coated tablet (tablet)
Jedna filmom obložena tableta sadrži:
Dolutegravir ↓ AUC ↓ 57% Cmax ↓ 39% Cτ ↓ 75%
efavirenz/dolutegravir dolutegravir ↓ AUC ↓ 57% Cmax ↓ 39% Cτ ↓ 75%
Table 7: Outcomes of randomized treatment of STRIIVING (snapshot algorithm) Study Outcomes (Plasma HIV-1 RNA <50 c/mL) at Week 24 and Week 48 - Snapshot Analysis (ITT-E Population)
Ishodi ispitivanja (plazmatski HIV-1 RNK < 50 kopija/ml) u 24. tjednu i 48. tjednu - analiza podataka prikupljenih pri samo jednom posjetu (engl. snapshot analysis) (ITT-E populacija) Fiksna kombinacija ABC/DTG/3TC N=275 n (%)
Since the recommended dose of dolutegravir is 50 mg twice daily when co-administered with these metabolic inducers, DTG/ABC/3TC FDC is not recommended for patients taking these metabolic inducers.
S obzirom da je preporučena doza dolutegravira 50 mg dvaput na dan kad se istodobno primjenjuje s navedenim metaboličkim induktorima, fiksna kombinacija dolutegravir/abakavir/lamivudin se ne preporučuje u bolesnika koji uzimaju navedene metaboličke induktore.
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 (50 times the 50 mg human clinical exposure when administered in combination with abacavir and lamivudine based on AUC).
6. do 17. dana gestacije nije uzrokovala toksičnost za majku, razvojnu toksičnost niti teratogenost (izloženost 50 puta veća od kliničke izloženosti u ljudi pri primjeni doze od 50 mg u kombinaciji s abakavirom i lamivudinom, što je utvrđeno na temelju AUC-a).
NAME OF THE MEDICINAL PRODUCT Triumeq 50 mg/600 mg/300 mg tablets dolutegravir/abacavir/lamivudine
Triumeq 50 mg/600 mg/300 mg tablete dolutegravir/abakavir/lamivudin
Rare side effects that may show up in blood tests are: • increase in an enzyme called amylase
• povećanje razine enzima koji se zove amilaza
Each tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir, 600 mg abacavir (as sulfate) and 300 mg lamivudine.
Jedna tableta sadrži 50 mg dolutegravira u obliku dolutegravirnatrija, 600 mg abakavira (u obliku abakavirsulfata) i 300 mg lamivudina.
Patients should be advised that Triumeq or any other antiretroviral therapy does not cure HIV infection and that they may still develop opportunistic infections and other complications of HIV infection.
Bolesnike se mora upozoriti da Triumeq ili bilo koja druga antiretrovirusna terapija ne može izliječiti
Dolutegravir ↓ AUC ↓ 22% Cmax ↓ 11% Cτ ↓ 38%
darunavir+ritonavir/ dolutegravir dolutegravir ↓ AUC ↓ 22% Cmax ↓ 11% Cτ ↓ 38%
2) you get one or more symptoms from at least TWO of the following groups - fever - shortness of breath, sore throat or cough - nausea or vomiting or diarrhoea or abdominal pain - severe tiredness or achiness or generally feeling ill
- nedostatak zraka, grlobolja ili kašalj - mučnina ili povraćanje ili proljev ili bol u trbuhu - izrazit umor ili bolovi ili opće loše osjećanje
headache
Nuspojava
Dolutegravir↓ AUC ↓ 35% Cmax ↓ 24% Cτ ↓ 49%
fosamprenavir+ritonavir/ dolutegravir dolutegravir↓ AUC ↓ 35% Cmax ↓ 24% Cτ ↓ 49%
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, prividni klirens nakon peroralne primjene (CL/F) u bolesnika s HIV infekcijom iznosi približno 1 l/h.
Very common side effects These may affect more than 1 in 10 people:
Vrlo rijetke nuspojave Mogu se javiti u do 1 na 10 000 osoba:
Frequency
Razno
Hepatic impairment Pharmacokinetic data has been obtained for dolutegravir, abacavir and lamivudine separately.
Oštećenje jetrene funkcije Prikupljeni su farmakokinetički podaci za dolutegravir, abakavir i lamivudin kao zasebne djelatne tvari.
Oral administration of dolutegravir to pregnant rabbits at doses up to 1000 mg/kg daily from days 6 to 18 of gestation did not elicit developmental toxicity or teratogenicity (0.74 times the 50mg human clinical exposure when administered in combination with abacavir and lamivudine based on AUC).
6. do 18. dana gestacije nije uzrokovala razvojnu toksičnost niti teratogenost (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 AUC-a).