natgillin/translations-raw huggingface dataset:
Oral carcinogenicity studies in rats and mice only revealed a low incidence of duodenal tumours at an extremely high-dose in mice.
Ispitivanja kancerogenosti nakon peroralne primjene provedena na štakorima i miševima pokazala su samo nisku incidenciju tumora dvanaesnika pri ekstremno visokim dozama u miševa.
Compared with subjects with normal renal function, the mean (% CV) tenofovir exposure increased from 2,185 (12 %) ng·h/mL in subjects with CrCl > 80 mL/min to respectively 3,064 (30 %) ng·h/mL, 6,009 (42 %) ng·h/mL and 15,985 (45 %) ng·h/mL in subjects with mild, moderate, and severe renal impairment.
U usporedbi s ispitanicima s normalnom funkcijom bubrega, srednja vrijednost (% CV) izloženosti tenofoviru porasla je s 2185 (12%) ng·h/ml u ispitanika kojima je CrCl iznosio > 80 ml/min na 3064 (30%) ng·h/ml, 6009 (42%) ng·h/ml i 15 985 (45%) ng·h/ml u ispitanika s blagim, umjerenim odnosno teškim oštećenjem funkcije bubrega.
Discontinued study due to AE or Death
Prekid ispitivanja zbog štetnog događaja ili smrti
GM: Geometric mean, %CV: Geometric coefficient of variation
Geometric coefficient of variation): geometrijski koeficijent varijacije
Co-administration of doravirine/lamivudine/tenofovir disproxil and medicinal products that are inhibitors of CYP3A may result in increased plasma concentrations of doravirine.
Istodobna primjena doravirina/lamivudina/tenofovirdizoproksila i lijekova koji su inhibitori CYP3A može povisiti koncentracije doravirina u plazmi.
In the DRIVE-SHIFT trial, an immediate switch to Delstrigo was demonstrated to be non-inferior at Week 48 compared to continuation of the baseline regimen at Week 24 as assessed by the proportion of subjects with HIV-1 RNA < 40 copies/mL.
U ispitivanju DRIVE-SHIFT, prelazak na Delstrigo bez odgode pokazao se neinferiornim u 48. tjednu u usporedbi s nastavkom početnog režima u 24. tjednu, što je procijenjeno prema omjeru ispitanika s HIV-1 RNK < 40 kopija/ml.
Doravirine is primarily metabolised by CYP3A, and medicinal products that induce or inhibit CYP3A are expected to affect the clearance of doravirine (see section 5.2).
Budući da se doravirin primarno metabolizira putem CYP3A, očekuje se da će lijekovi koji induciraju ili inhibiraju CYP3A utjecati na klirens doravirina (vidjeti dio 5.2).
• feeling weak, general feeling of being unwell
• slabost, opće loše osjećanje
Other substitutions yielded a fold change of 5-10 (G190S (5.7); K103N/P225H (7.9), V108I/Y181C (6.9), Y181V (5.1)).
Uz ostale supstitucije zabilježena je promjena 5 - 10 puta (G190S [5,7 puta], K103N/P225H [7,9 puta], V108I/Y181C [6,9 puta], Y181V [5,1 put]).
Lamivudine was mutagenic in an L5178Y mouse lymphoma assay and clastogenic in a cytogenetic assay using cultured human lymphocytes.
Lamivudin je bio mutagen u testu na stanicama mišjeg limfoma L5178Y i klastogen u citogenetskom testu na kulturi humanih limfocita.
The clinically relevant effects noted were a reduction in red blood cell count and neutropenia.
Opaženi klinički značajni učinci bili su smanjenje broja eritrocita i neutropenija.
• ledipasvir/sofosbuvir (medicines used to treat hepatitis C infection)
• ledipasvir/sofosbuvir (lijekovi koji se koriste za liječenje infekcije virusom hepatitisa C)
Metabolism and nutrition disorders Uncommon hypophosphataemia, hypokalaemia*
Poremećaji metabolizma i prehrane manje često hipofosfatemija, hipokalijemija*
• feeling of incomplete defecation
• osjećaj nepotpunog pražnjenja crijeva
Because a negligible amount of lamivudine was removed via (4-hour) haemodialysis, continuous ambulatory peritoneal dialysis, and automated peritoneal dialysis, it is not known if continuous haemodialysis would provide clinical benefit in a lamivudine overdose event.
Budući da je (4-satnom) hemodijalizom, kontinuiranom ambulantnom peritonejskom dijalizom i automatiziranom peritonejskom dijalizom uklonjena zanemariva količina lamivudina, nije poznato bi li kontinuirana hemodijaliza bila klinički korisna u slučaju predoziranja lamivudinom.
Tenofovir displayed antiviral activity in cell culture against HIV-1 clades A, B, C, D, E, F, G, and O (EC50 values ranged from 0.5-2.2 microM).
Tenofovir je u staničnoj kulturi pokazao antivirusnu aktivnost protiv virusa HIV-1 podtipa A, B, C, D, E, F, G i O (vrijednosti EC50 kretale su se u rasponu od 0,5 do 2,2 µM).
Pharmacokinetic parameters of tenofovir were determined following administration of a single dose of tenofovir disoproxil 245 mg to 40 non-HIV infected adult subjects with varying degrees of renal impairment defined according to baseline CrCl (normal renal function when CrCl > 80 mL/min; mild with CrCl = 50-79 mL/min; moderate with CrCl = 30-49 mL/min and severe with CrCl = 10-29 mL/min).
Farmakokinetički parametri tenofovira određivali su se nakon primjene jednokratne doze tenofovirdizoproksila od 245 mg u 40 odraslih ispitanika bez HIV infekcije koji su imali različite stupnjeve oštećenja funkcije bubrega definiranog prema početnom klirensu kreatinina (normalna funkcija bubrega: CrCl > 80 ml/min; blago oštećenje: CrCl=50 - 79 ml/min; umjereno oštećenje: CrCl=30 - 49 ml/min; teško oštećenje: CrCl=10 - 29 ml/min).
• 1 bottle with 30 film-coated tablets
• 1 boca s 30 filmom obloženih tableta
DOR + NRTIs*
DOR + NRTI-ji*
Subsequently F227(L/C/V) or L234I emerged in addition to V106 substitutions (double mutants yielding a fold change of > 100).
Nakon toga se uz supstitucije V106 javila i mutacija F227(L/C/V) ili L234I (dvostruke mutacije koje su dovele do promjene > 100 puta u odnosu na početnu vrijednost).
• feeling sick (nausea), diarrhoea, stomach pain, vomiting, wind (flatulence)
• mučnina, proljev, bol u trbuhu, povraćanje, vjetrovi (flatulencija)
Bone problems include bone pain, and bone softening or thinning (which may lead to fractures).
Tegobe s kostima uključuju bol u kostima te omekšavanje ili stanjivanje kosti (koje može dovesti do prijeloma).
• This medicinal product does not require any special temperature storage conditions.
• Lijek ne zahtijeva čuvanje na određenoj temperaturi.
• St. John's wort (Hypericum perforatum)
• gospinu travu (Hypericum perforatum)
Doravirine was not genotoxic in a battery of in vitro or in vivo assays.
Doravirin Doravirin nije bio genotoksičan u nizu testova in vitro ili in vivo.
Co-administration with medicinal products that are strong cytochrome P450 CYP3A enzyme inducers is contraindicated as significant decreases in doravirine plasma concentrations are expected to occur, which may decrease the effectiveness of Delstrigo (see sections 4.4 and 4.5).
Istodobna primjena s lijekovima koji su snažni induktori enzima citokroma P450 CYP3A kontraindicirana je jer se očekuju značajna sniženja koncentracija doravirina u plazmi, koja mogu smanjiti učinkovitost lijeka Delstrigo (vidjeti dijelove 4.4 i 4.5).
If a patient misses a dose of Delstrigo by more than 12 hours, the patient should not take the missed dose and instead take the next dose at the regularly scheduled time.
Ako je od propuštene doze prošlo više od 12 sati, bolesnik ne smije uzeti propuštenu dozu, nego treba uzeti sljedeću predviđenu dozu prema uobičajenom rasporedu.
Delstrigo is a complete regimen taken as a single tablet for the treatment of HIV infection.
Delstrigo je cjelovit režim za liječenje HIV infekcije, koji se uzima u obliku jedne tablete.
Doravirine-resistant strains were selected in cell culture starting from wild-type HIV-1 of different origins and subtypes, as well as NNRTI-resistant HIV-1.
Sojevi rezistentni na doravirin izdvojeni su u staničnoj kulturi, počevši od HIV-1 divljeg tipa različitog podrijetla i podtipova te HIV-1 rezistentnog na NNRTI-je.
In DRIVE-FORWARD, 766 subjects were randomised and received at least 1 dose of either doravirine 100 mg or darunavir + ritonavir 800+100 mg once daily, each in combination with emtricitabine/tenofovir disoproxil (FTC/TDF) or abacavir/lamivudine (ABC/3TC) selected by the investigator.
U ispitivanju DRIVE-FORWARD, randomizirano je 766 ispitanika koji su primili najmanje 1 dozu doravirina od 100 mg jedanput na dan ili darunavira + ritonavira u dozi od 800+100 mg jedanput na dan, svaki u kombinaciji s emtricitabinom/tenofovirdizoproksilom (FTC/TDF) ili abakavirom/lamivudinom (ABC/3TC), prema izboru ispitivača.
Tenofovir Cmax decreased by 12 % and AUC increased by 27 % with a high fat meal.
Cmax tenofovira se uz obrok s visokim udjelom masnoća smanjio za 12%, dok se AUC povećao za 27%.
HIV-1 isolates with the K65R substitution also showed reduced susceptibility to emtricitabine and lamivudine.
Izolati HIV-1 sa supstitucijom K65R pokazali su i smanjenu osjetljivost na emtricitabin te lamivudin.
• sirolimus (a medicine used to control your body's immune response after a transplant)
• sirolimus (lijek koji se koristi za kontroliranje odgovora imunološkog sustava nakon presađivanja)
Film-coated tablets 30 film-coated tablets 90 (3 bottles of 30) film-coated tablets
Filmom obložene tablete 30 filmom obloženih tableta 90 (3 boce s 30) filmom obloženih tableta
How Delstrigo works
Kako Delstrigo djeluje
• joint pain, breakdown of muscle tissue, muscular weakness
• bol u zglobovima, oštećenje mišićnog tkiva, slabost u mišićima
At baseline, the median age of subjects was 31 years (range 18-70 years), 85 % were male, 52 % were non-white, 3 % had hepatitis B or C co-infection, 14 % had a history of AIDS, 21 % had HIV-1 RNA > 100,000 copies per mL, and 12 % had CD4
Medijan dobi ispitanika na početku ispitivanja iznosio je 31 godinu (raspon: 18 - 70 godina), 85% bili su muškarci, 52% ispitanika nije bilo bijele rase, 3% istodobno je imalo infekciju virusom hepatitisa B ili C, 14% imalo je AIDS u anamnezi, 21% imalo je razinu HIV-1 RNK višu od 100 000 kopija/ml, a 12% ih je imalo broj CD4
Expected: ↑ tenofovir
Očekivano: ↑ tenofovir
The oral bioavailability of tenofovir from tenofovir disoproxil in fasted subjects is approximately 25 %.
Bioraspoloživost tenofovira iz tenofovirdizoproksila nakon peroralne primjene iznosi približno 25%.
*This adverse reaction was not identified as an adverse reaction associated with doravirine from the Phase 3 clinical studies (DRIVE-FORWARD, DRIVE-AHEAD, DRIVE-SHIFT), but is included in this table as an adverse reaction based on the Summary of Product Characteristics of 3TC and/or TDF.
*Ova nuspojava nije utvrđena kao nuspojava povezana s doravirinom u kliničkim ispitivanjima faze 3 (DRIVE-FORWARD, DRIVE-AHEAD, DRIVE-SHIFT), ali je kao nuspojava uključena u ovu tablicu prema sažetku opisa svojstava lijeka za lamivudin (3TC) i/ili tenofovirdizoproksilfumarat (TDF).
Patients with moderate or severe renal impairment require a dose interval adjustment of lamivudine and tenofovir disoproxil that cannot be achieved with the combination tablet (see sections 4.4 and 5.2).
Bolesnicima s umjerenim ili teškim oštećenjem funkcije bubrega potrebna je prilagodba intervala doziranja lamivudina i tenofovirdizoproksila koja se ne može postići kombiniranom tabletom (vidjeti dijelove 4.4 i 5.2).
If you take more Delstrigo than you should Do not take more than the recommended dose.
Nemojte uzeti više od preporučene doze.
In an in vivo mouse micronucleus assay, tenofovir disoproxil was negative when administered to male mice.
U mišjem mikronukleusnom testu in vivo tenofovirdizoproksil je bio negativan kada je primijenjen mužjacima miševa.
Delstrigo should be discontinued if estimated CrCl declines below 50 mL per minute as dose interval adjustment required for lamivudine and tenofovir disoproxil cannot be achieved with the fixed dose combination tablet (see section 4.2).
Primjenu lijeka Delstrigo treba prekinuti ako procijenjeni CrCl padne ispod 50 ml/min jer se potrebna prilagodba intervala doziranja lamivudina i tenofovirdizoproksila ne može postići tabletom s fiksnom kombinacijom doza (vidjeti dio 4.2).
Consistent results were seen for the comparison at Study Week 24 in each treatment group.
Rezultati liječenja prikazani su u Tablici 5. Prilikom usporedbe u 24. tjednu ispitivanja, primijećeni su dosljedni rezultati u obje liječene skupine.
Lamivudine was not mutagenic in a microbial mutagenicity assay, in an in vitro cell transformation assay, in a rat micronucleus test, in a rat bone marrow cytogenetic assay, and in an assay for unscheduled DNA synthesis in rat liver.
Lamivudin nije bio mutagen u testu mikrobne mutagenosti, testu stanične transformacije in vitro, mikronukleusnom testu na štakorima, citogenetskom testu na koštanoj srži štakora, kao ni u testu neplanirane sinteze DNK u jetri štakora.
No dose adjustment of doravirine/lamivudine/tenofovir disoproxil is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment.
Nije potrebno prilagođavati dozu doravirina/lamivudina/tenofovirdizoproksila u bolesnika s blagim (Child-Pugh stadij A) ili umjerenim (Child-Pugh stadij B) oštećenjem funkcije jetre.
What Delstrigo looks like and contents of the pack Delstrigo is available as a yellow, oval-shaped, film-coated tablet, and is debossed with the corporate logo and 776 on one side and plain on the other side.
Delstrigo je žuta, ovalna filmom obložena tableta s utisnutim logotipom proizvođača i oznakom „776“ na jednoj strani i bez oznake na drugoj strani.
Lamivudine-resistant variants of HIV-1 have been selected in cell culture and in subjects treated with lamivudine.
Varijante HIV-1 rezistentne na lamivudin izdvojene su u staničnoj kulturi i u ispitanika liječenih lamivudinom.
Lamivudine-resistant HIV-1 mutants were also cross resistant to didanosine (ddI).
Mutirani oblici HIV-1 rezistentni na lamivudin također su pokazali križnu rezistenciju i na didanozin.
2031 BN Haarlem NETHERLANDS
2031 BN Haarlem NIZOZEMSKA
HIV-1 isolates from patients (n = 20) whose HIV-1 expressed a mean of 3 zidovudine associated RT amino acid substitutions (M41L, D67N, K70R, L210W, T215Y/F, or K219Q/E/N) showed a 3.1-fold decrease in the susceptibility to tenofovir.
Izolati HIV-1 u bolesnika (n=20) čiji HIV-1 eksprimira srednju vrijednost od 3 aminokiselinske supstitucije u reverznoj transkriptazi povezane s rezistencijom na zidovudin (M41L, D67N, K70R, L210W, T215Y/F ili K219Q/E/N) pokazali su 3,1 puta smanjenu osjetljivost na tenofovir.
A breakpoint for a reduction in susceptibility, yielded by various NNRTI substitutions, that is associated with a reduction in clinical efficacy has not been established (see section 5.1).
Nije utvrđena granična vrijednost za smanjenje osjetljivosti, uzrokovano različitim supstitucijama koje dovode do rezistencije na NNRTI-je, koje bi bilo povezano sa smanjenjem kliničke djelotvornosti (vidjeti dio 5.1).
The Phase 3 studies, DRIVE-FORWARD and DRIVE-AHEAD, included previously untreated patients (n = 747) where the following NNRTI substitutions were part of exclusion criteria: L100I, K101E, K101P, K103N, K103S, V106A, V106I, V106M, V108I, E138A, E138G, E138K, E138Q, E138R, V179L, Y181C, Y181I, Y181V, Y188C, Y188H, Y188L, G190A, G190S, H221Y, L234I, M230I, M230L, P225H, F227C, F227L, F227V.
U ispitivanjima faze 3 DRIVE-FORWARD i DRIVE-AHEAD sudjelovali su prethodno neliječeni bolesnici (n = 747), a sljedeće supstitucije povezane s rezistencijom na NNRTI-je bile su dio isključnih kriterija: L100I, K101E, K101P, K103N, K103S, V106A, V106I, V106M, V108I, E138A, E138G, E138K, E138Q, E138R, V179L, Y181C,Y181I, Y181V, Y188C, Y188H, Y188L, G190A, G190S, H221Y, L234I, M230I, M230L, P225H, F227C, F227L, F227V.
The DRIVE-SHIFT study included virologically suppressed patients (N=670) with no history of treatment failure (see section, Clinical experience).
Odrasli ispitanici u kojih je postignuta virološka supresija Ispitivanje DRIVE-SHIFT uključilo je bolesnike u kojih je postignuta virološka supresija (N=670) i koji u anamnezi nemaju neuspješno liječenje (vidjeti dio Kliničko iskustvo).
The highest frequency category reported in the 3TC or TDF Summary of Product Characteristics is used.
Navedena je najveća učestalost prijavljena u sažetku opisa svojstava lijeka za 3TC ili TDF.
Use with CYP3A inducers
Primjena s induktorima CYP3A4
Keep the bottle tightly closed in order to protect from moisture.
Bocu čuvati čvrsto zatvorenom radi zaštite od vlage.
Subjects were randomized to either switch to Delstrigo at baseline [N= 447, Immediate Switch Group (ISG)], or stay on their baseline regimen until Week 24, at which point they switched to Delstrigo [N= 223, Delayed Switch Group (DSG)].
Immediate Switch Group (ISG)] ili su ostali pri svom početnom režimu do 24. tjedna, nakon čega su prešli na Delstrigo [N=223, skupina s odgođenim prelaskom, engl.
Severe acute exacerbation of hepatitis B in patients co-infected with HIV-1 and HBV All patients with HIV-1 should be tested for the presence of hepatitis B virus (HBV) before initiating antiretroviral therapy.
Sve bolesnike s HIV-1 infekcijom potrebno je testirati na prisutnost virusa hepatitisa B (HBV) prije uvođenja antiretrovirusne terapije.
Tenofovir is eliminated by a combination of glomerular filtration and active tubular secretion with a renal clearance in adults with CrCl greater than 80 mL per minute of 243.5 ± 33.3 mL per minute (mean ± SD).
Tenofovir se eliminira kombinacijom glomerularne filtracije i aktivne tubularne sekrecije, uz bubrežni klirens od 243,5 ± 33,3 ml/min (srednja vrijednost ± standardno odstupanje) u odraslih osoba kojima je CrCl veći od 80 ml/min.
The pharmacokinetics of tenofovir in non-haemodialysis adult subjects with CrCl < 10 mL/min and in subjects with end-stage renal disease managed by peritoneal or other forms of dialysis have not been studied.
Farmakokinetika tenofovira nije se ispitivala u odraslih ispitanika kojima je CrCl < 10 ml/min i koji nisu na hemodijalizi niti u ispitanika u terminalnoj fazi bubrežne bolesti liječenih peritonejskom dijalizom ili nekom drugom vrstom dijalize.
• lesinurad (a medicine to treat gout)
• lesinurad (lijek za liječenje gihta)
• increased levels of amylase
• povišene vrijednosti amilaze
Doravirine/lamivudine/tenofovir disoproxil should not be co-administered with medicinal products that are strong CYP3A enzyme inducers as significant decreases in doravirine plasma concentrations are expected to occur, which may decrease the effectiveness of doravirine/lamivudine/tenofovir disoproxil (see sections 4.3 and 5.2).
Doravirin/lamivudin/tenofovirdizoproksil ne smije se primjenjivati istodobno s lijekovima koji su snažni induktori enzima CYP3A jer se očekuju značajna sniženja koncentracija doravirina u plazmi, koja mogu smanjiti učinkovitost doravirina/lamivudina/tenofovirdizoproksila (vidjeti dijelove 4.3 i 5.2).
Clinical isolates containing the Y188L substitution or V106 substitutions in combination with A98G, H221Y, P225H, F227C or Y318F showed a greater than 100-fold reduced susceptibility to doravirine.
Klinički izolati koji su sadržavali supstituciju Y188L ili supstitucije V106 u kombinaciji s mutacijama A98G, H221Y, P225H, F227C ili Y318F pokazali su više od sto puta smanjenu osjetljivost na doravirin.
The K70E substitution selected clinically by tenofovir disoproxil results in reduced susceptibility to abacavir, didanosine, emtricitabine, lamivudine, and tenofovir.
Supstitucija K70E klinički izdvojena tenofovirdizoproksilom smanjuje osjetljivost na abakavir, didanozin, emtricitabin, lamivudin i tenofovir.
Hepatobiliary disorders Rare hepatic steatosis*, hepatitis*
Poremećaji jetre i žuči rijetko steatoza jetre*, hepatitis*
None of the 24 subjects (11 in the immediate switch group, 13 in the delayed switch group) with baseline NNRTI mutations (RT K103N, G190A, or Y181C) experienced virologic failure through Week 48, or at time of discontinuation.
Ni u jednog od 24 ispitanika (11 u skupini s prelaskom bez odgode, 13 u skupini s odgođenim prelaskom) s početnim mutacijama povezanima s rezistencijom na NNRTI-je (K103N, G190A ili Y181C u reverznoj transkriptazi) nije došlo do izostanka virološkog odgovora do 48. tjedna ili u trenutku prekida liječenja.
Mineralisation defects
Poremećaji mineralizacije
Refill your prescription or talk to your doctor before your Delstrigo is all gone.
Preuzmite novo pakiranje ili se obratite svom liječniku prije nego što potrošite sve tablete lijeka Delstrigo.
Tenofovir disoproxil is an acyclic nucleoside phosphonate diester analog of adenosine monophosphate.
Tenofovirdizoproksil je aciklički nukleozidni fosfonatni diesterski analog adenozinfosfata.
• telotristat ethyl (a medicine to treat diarrhea in people with carcinoid syndrome)
• etiltelotristat (lijek za liječenje proljeva u osoba s karcinoidnim sindromom)
For potential medicine product interactions with tenofovir disoproxil or lamivudine, (see sections 4.4 and 5.2).
Za moguće interakcije tenofovirdizoproksila i lamivudina s drugim lijekovima (vidjeti dijelove 4.4 i 5.2).
HIV-1 isolates selected by tenofovir expressed a K65R substitution in HIV-1 RT and showed a 2-4 fold reduction in susceptibility to tenofovir.
Izolati HIV-1 izdvojeni tenofovirom eksprimirali su supstituciju K65R u reverznoj transkriptazi HIV-1 te su pokazivali 2 - 4 puta smanjenu osjetljivost na tenofovir.
Delstrigo should be avoided with concurrent or recent use of nephrotoxic medicinal products (e.g., high-dose or multiple nonsteroidal anti-inflammatory medicinal products [NSAIDs]) (see section 4.5).
Potrebno je izbjegavati primjenu lijeka Delstrigo istodobno ili neposredno nakon primjene nefrotoksičnih lijekova (npr. primjena visokih doza ili više različitih nesteroidnih protuupalnih lijekova [NSAIL] istovremeno) (vidjeti dio 4.5).
This is achieved by adding one 100 mg tablet of doravirine (as a single agent), to be taken approximately 12 hrs apart from the dose of Delstrigo (see section 4.5).
To se postiže dodavanjem jedne tablete doravirina od 100 mg (kao monoterapije), približno 12 sati nakon doze lijeka Delstrigo (vidjeti dio 4.5).
Single-dose administration of one doravirine/lamivudine/tenofovir disoproxil tablet to healthy subjects (N = 24) under fasted conditions provided comparable exposures of doravirine, lamivudine, and tenofovir to administration of doravirine tablets (100 mg) plus lamivudine tablets (300 mg) plus tenofovir disoproxil tablets (245 mg).
Jednokratna primjena jedne tablete doravirina/lamivudina/tenofovirdizoproksila zdravim ispitanicima (N=24) natašte dovela je do usporedivih razina izloženosti doravirinu, lamivudinu i tenofoviru kao i primjena zasebnih tableta doravirina (100 mg) plus lamivudina (300 mg) plus tenofovirdizoproksila (245 mg).
≥ 200 cells/mm
≥ 200 stanica/mm
Expected:  norgestimate/ethinyl oestradiol
Očekivano: ↔ norgestimat/etinilestradiol
Effects of doravirine, lamivudine, and tenofovir disoproxil on other medicinal products Doravirine
Učinci doravirina, lamivudina i tenofovirdizoproksila na druge lijekove
Doravirine has not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Doravirin se nije ispitivao u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh stadij C).
Film-coating Carnauba wax (E903) Hypromellose (E464) Iron oxide yellow (E172) Lactose monohydrate Titanium dioxide (E171) Triacetin (E1518)
Film ovojnica karnauba vosak (E903) hipromeloza (E464) željezov oksid, žuti (E172) laktoza hidrat titanijev dioksid (E171) triacetin (E1518)
Co-administration of doravirine with other moderate CYP3A inducers has not been evaluated, but decreased doravirine concentrations are expected.
Istodobna primjena doravirina s drugim umjerenim induktorima CYP3A nije se ocjenjivala, ali očekuju se smanjene koncentracije doravirina.
Sedatives/Hypnotics midazolam (2 mg SD, doravirine 120 mg QD)
Sedativi/hipnotici midazolam (2 mg SD, doravirin 120 mg QD)
A breakpoint for a reduction in susceptibility, yielded by various NNRTI substitutions, that is associated with a reduction in clinical efficacy has not been established.
Nije utvrđena granična vrijednost za smanjenje osjetljivosti, uzrokovano različitim supstitucijama koje dovode do rezistencije na NNRTI-je, koje bi bilo povezano sa smanjenjem kliničke djelotvornosti.
< 200 cells/mm
< 200 stanica/mm
Doravirine has not been studied in patients with end-stage renal disease or in patients undergoing dialysis (see section 4.2).
Doravirin se nije ispitivao u bolesnika u završnom stadiju bubrežne bolesti ni u bolesnika na dijalizi (vidjeti dio 4.2).