natgillin/translations-raw huggingface dataset:
• telotristat ethyl (a medicine to treat diarrhea in people with carcinoid syndrome)
• etiltelotristat (zdravilo za zdravljenje driske pri osebah s karcinoidnim sindromom),
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
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
V izhodišču je bila mediana starost preiskovancev 31 let (razpon: od 18 do 70 let), 85 % je bilo moških, 52 % je bilo nebelcev, 3 % so imeli sočasno okužbo z virusom hepatitisa B in/ali C, 14 % je imelo v anamnezi aids, 21 % je imelo HIV-1 RNA > 100.000 kopij/ml in 12 % jih je imelo število celic T CD4 < 200 celic/mm
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.
V primerjavi s preiskovanci z normalnim delovanjem ledvic se je povprečna (% KV) izpostavljenost tenofovirju od 2.185 (12 %) ng·h/ml pri preiskovancih z očistkom kreatinina > 80 ml/min pri preiskovancih z blago okvaro povečala na 3.064 ng·h/ml (30 %), pri tistih z zmerno okvaro na 6.009 ng·h/ml (42 %) in tistih s hudo okvaro ledvic na 15.985 ng·h/ml (45 %).
Baseline regimen = ritonavir or cobicistat-boosted PI (specifically atazanavir, darunavir, or lopinavir), or cobicistat-boosted elvitegravir, or NNRTI (specifically efavirenz, nevirapine, or rilpivirine), each administered with two NRTIs.
Izhodiščna shema = zaviralec proteaz (specifično atazanavir, darunavir ali lopinavir), ojačen z ritonavirjem ali kobicistatom, ali elvitegravir, ojačen s kobicistatom, ali NNRTI (specifično efavirenz, nevirapin ali rilpivirin), vsi uporabljeni z dvema NRTI.
Administration of lamivudine in animal toxicity studies at high doses was not associated with any major organ toxicity.
Uporaba velikih odmerkov lamivudina v študijah toksičnosti na živalih ni bila povezana s toksičnimi učinki na katerega od pomembnih organov.
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 bolnikov (n = 20), katerih HIV-1 je imel izražene povprečno 3 z zidovudinom povezane aminokislinske substitucije RT (M41L, D67N, K70R, L210W, T215Y/F ali K219Q/E/N), so imeli 3,1-krat manjšo občutljivost za tenofovir.
Refill your prescription or talk to your doctor before your Delstrigo is all gone.
Zdravilo prevzemite v lekarni ali se posvetujte z zdravnikom, še preden vam zmanjka zdravila Delstrigo.
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.
V preskušanju DRIVE-FORWARD je bilo randomiziranih 766 preiskovancev in prejeli so vsaj 1 odmerek bodisi 100 mg doravirina bodisi kombinacije darunavirja + ritonavirja 800 + 100 mg enkrat na dan, oboje v kombinaciji z emtricitabinom/dizoproksiltenofoviratom (FTC/TDF) ali z abakavirjem/lamivudinom (ABC/3TC) po izbiri raziskovalca.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Če imate kakršna koli dodatna vprašanja o uporabi tega zdravila, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Mean CD4 change from baseline
Povprečna sprememba CD4 od izhodišča
Uncommon myalgia, arthralgia, rhabdomyolysis* muscular weakness*
Občasni mialgija, artralgija, rabdomioliza* †, šibkost mišic*
The K70E substitution selected clinically by tenofovir disoproxil results in reduced susceptibility to abacavir, didanosine, emtricitabine, lamivudine, and tenofovir.
Substitucija K70E, klinično selekcionirana z dizoproksiltenofoviratom, zmanjša občutljivost za abakavir, didanozin, emtricitabin, lamivudin in tenofovir.
• decreased levels of magnesium
• znižanje koncentracije magnezija
This adverse reaction may occur as a consequence of proximal renal tubulopathy.
Ta neželeni učinek se lahko pojavi kot posledica proksimalne ledvične tubulopatije.
Joint or muscle pain or muscle weakness may also occur.
Pojavijo se lahko tudi bolečine v sklepih ali mišicah ali šibkost mišic.
Medicinal Product by Therapeutic Area
Zdravila po terapevtskih področjih
• decreased number of white blood cells in your blood (neutropenia)
• zmanjšanje števila belih krvnih celic (nevtropenija)
Consistent results were seen for the comparison at Study Week 24 in each treatment group.
V 24. tednu so bili rezultati med obema terapevtskima skupinama primerljivi.
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).
Farmakokinetične parametre tenofovirja so določili po uporabi enkratnega odmerka 245 mg dizoproksiltenofovirata pri 40 osebah, ki niso bile okužene s HIV in so imele glede na izhodiščni očistek kreatinina različno stopnjo okvare ledvic (normalno delovanje ledvic: očistek kreatinina > 80 ml/min, blaga okvara = 50-79 ml/min, zmerna okvara = 30-49 ml/min in huda okvara = 10-29 ml/min).
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.
Hemodializa (4-urna), stalna ambulantna peritonealna dializa in avtomatska peritonealna dializa so odstranile le zanemarljivo količino lamivudina, zato ni znano, ali bi stalna hemodializa v primeru prevelikega odmerjanja lamivudina klinično koristila.
There are limited data available on the use of doravirine, lamivudine, and tenofovir disoproxil in patients aged 65 years and over.
Podatkov o uporabi doravirina, lamivudina in dizoproksiltenofovirata pri bolnikih, starih 65 let ali več, je malo.
Film-coating Carnauba wax (E903) Hypromellose (E464) Iron oxide yellow (E172) Lactose monohydrate Titanium dioxide (E171) Triacetin (E1518)
Filmska obloga karnauba vosek (E903) hipromeloza (E464) rumeni železov oksid (E172) laktoza monohidrat titanov dioksid (E171) triacetin (E1518)
Reproductive toxicity studies in rats and rabbits showed no effects on mating, fertility, pregnancy or foetal parameters.
Rezultati študij o vplivu na sposobnost razmnoževanja pri podganah in kuncih niso pokazali učinkov na parametre parjenja, plodnosti, brejosti ali ploda.
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 dosežemo z dodatkom 100-mg tablete doravirina (kot samostojnega zdravila), ki jo bolnik vzame približno 12 ur po odmerku zdravila Delstrigo (glejte poglavje 4.5).
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).
Pri bolnikih z zmerno ali hudo okvaro ledvic je treba prilagoditi interval odmerjanja lamivudina in dizoproksiltenofovirata, to pa s kombinirano tableto ni mogoče (glejte poglavji 4.4 in 5.2).
Doravirine has not been studied in subjects with severe hepatic impairment (Child-Pugh score C) (see section 4.2).
Doravirin ni raziskan pri bolnikih s hudo okvaro jeter (Child-Pugh C) (glejte poglavje 4.2).
Difference (95 % CI)
Razlika med zdravljenjema (95 % IZ)
Expected: ↑ tenofovir
Pričakovano: ↑ tenofovir
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.
V študijah 3. faze DRIVE-FORWARD in DRIVE-AHEAD so bili vključeni predhodno še nezdravljeni bolniki (n = 747); med merili za nevključitev v teh dveh študijah so bile naslednje z NNRTI povezane substitucije: 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 efficacy of switching from a baseline regimen consisting of two nucleoside reverse transcriptase inhibitors in combination with a ritonavir- or cobicistat-boosted PI, or cobicistat-boosted elvitegravir, or an NNRTI to Delstrigo was evaluated in a randomized, open-label trial (DRIVE-SHIFT), in virologically suppressed HIV-1 infected adults.
Učinkovitost prehoda z izhodiščne sheme (ki je obsegala dva nukleozidna zaviralca reverzne transkriptaze v kombinaciji z zaviralcem proteaz, ojačenim z ritonavirjem ali kobicistatom, ali z elvitegravirjem, ojačenim s kobicistatom, ali z nekim NNRTI) na zdravilo Delstrigo so ocenili v randomiziranem, odprtem preskušanju (DRIVE-SHIFT) pri virološko suprimiranih odraslih, okuženih s HIV-1.
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)].
Preiskovance so randomizirali bodisi na prehod na zdravilo Delstrigo izhodiščno [N = 447, skupina s takojšnjim prehodom (ISG - Immediate Switch Group)] bodisi na nadaljevanje izhodiščne sheme do 24. tedna, ko so prešli na zdravilo Delstrigo [N = 223, skupina z odloženim prehodom (DSG - Delayed Switch Group)].
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.
Zdravilo Delstrigo je na voljo v obliki rumenih filmsko obloženih tablet ovalne oblike z vtisnjenim logotipom podjetja in oznako 776 na eni strani in brez oznake na drugi strani.
Pharmacotherapeutic group: Antivirals for systemic use, ATC code: J05AR24
Oznaka ATC: J05AR24
Blood and lymphatic systems disorders Uncommon neutropenia*, anaemia*, thrombocytopenia*
Bolezni krvi in limfatičnega sistema Občasni nevtropenija*, anemija*, trombocitopenija*
In the DRIVE-SHIFT clinical trial, no subjects developed genotypic or phenotypic resistance to DOR, 3TC, or TDF during the initial 48 weeks (immediate switch, N=447) or 24 weeks (delayed switch, N=209) of treatment with Delstrigo.
V kliničnem preskušanju DRIVE-SHIFT se med zdravljenjem z zdravilom Delstrigo pri nobenem preiskovancu v prvih 48 tednih (takojšen prehod, N=447) ali 24 tednih (odložen prehod, N=209) ni pojavila ne genotipska ne fenotipska odpornost proti DOR, 3TC ali TDF.
Due to the tenofovir disoproxil component of doravirine/lamivudine/tenofovir disoproxil, use of the product should be avoided with concurrent or recent use of nephrotoxic medicinal products.
Zaradi dizoproksiltenofovirata v kombinaciji doravirin/lamivudin/dizoproksiltenofovirat se je uporabi kombinacije treba izogniti v primeru trenutne ali nedavne uporabe nefrotoksičnih zdravil.
Each carton contains a high density polyethylene (HDPE) bottle with a polypropylene child-resistant closure with silica gel desiccants.
Vsaka škatla vsebuje plastenko iz polietilena velike gostote (HDPE) s polipropilensko, za otroke varno zaporko in silicijevim dioksidom kot sušilom.
Renal and urinary disorders Uncommon increased creatinine*, proximal renal tubulopathy (including Fanconi syndrome)*
Bolezni sečil Občasni zvišanje kreatinina*, proksimalna ledvična tubulopatija (vključno s Fanconijevim sindromom)*
Delstrigo 100 mg/300 mg/245 mg film-coated tablets.
Delstrigo 100 mg/300 mg/245 mg filmsko obložene tablete
Oral carcinogenicity studies in rats and mice only revealed a low incidence of duodenal tumours at an extremely high-dose in mice.
Rezultati študij peroralne kancerogenosti pri podganah in miših so pokazali majhno pojavnost tumorjev dvanajstnika ob uporabi izredno velikega odmerka pri miših.
If you are not sure, talk to your doctor, pharmacist, or nurse before taking Delstrigo.
Če ste negotovi, se pred začetkom jemanja zdravila Delstrigo posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Lamivudine Cmax decreased by 19 % with a high fat meal, while AUC was not significantly affected.
Zelo masten obrok je zmanjšal Cmax lamivudina za 19 % in ni pomembno vplival na AUC.
Tenofovir disoproxil is an acyclic nucleoside phosphonate diester analog of adenosine monophosphate.
Dizoproksiltenofovirat je acikličen nukleozidni fosfonatni diestrski analog adenozinmonofosfata.
Tenofovir diphosphate is a weak inhibitor of mammalian DNA polymerases α, β, and mitochondrial DNA polymerase γ.
Tenofovirdifosfat je šibek zaviralec DNA polimeraz α in β pri sesalcih ter mitohondrijske DNA polimeraze γ.
DRV+r + NRTIs*
DRV+r + 2 NRTI
Limited data are available for patients whose virus expressed a Y115F substitution (n = 3), Q151M substitution (n = 2), or T69 insertion (n = 4) in HIV-1 RT, all of whom had a reduced response in clinical trials.
RT HIV-1 izraženo substitucijo Y115F (n = 3), substitucijo Q151M (n = 2) ali insercijo T69 (n = 4); vsi ti bolniki so imeli v kliničnih preskušanjih zmanjšan odziv.
However, tenofovir disoproxil reduced the viability index and weight of pups in a peri-postnatal toxicity study at maternally toxic doses.
Vendar pa je dizoproksiltenofovirat v peripostnatalni študiji zmanjšal indeks viabilnosti in telesne mase mladičev ob uporabi odmerkov, toksičnih za samico.
• difficulty breathing, enlarged tonsils
• težave z dihanjem, povečanje mandljev (tonzil)
Expected:  doravirine ↑ tenofovir
Pričakovano:  doravirin ↑ tenofovir
Long-term carcinogenicity studies with lamivudine in mice and rats showed no evidence of carcinogenic potential at exposures up to 12 times (mice) and 57 times (rats) the human exposures at the RHD.
Rezultati dolgoročnih študij kancerogenosti z lamivudinom pri miših in podganah niso pokazali znakov kancerogenega potenciala ob izpostavljenostih, ki so bile do 12-krat (miši) oz. 57-krat (podgane) večje kot izpostavljenost pri človeku med uporabo RHD.
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).
Kontraindicirana je sočasna uporaba z močnimi induktorji encima citokroma P450 CYP3A, ker je mogoče pričakovati pomembno zmanjšanje koncentracije doravirina v plazmi, to pa lahko zmanjša učinkovitost zdravila Delstrigo (glejte poglavji 4.4 in 4.5).
Biotransformation Based on in vitro data, doravirine is primarily metabolised by CYP3A.
Na podlagi podatkov in vitro se doravirin v prvi vrsti presnovi s CYP3A.
CD4 count, cells/µL
Število celic CD4 (celic/µl)
The pharmacokinetics of doravirine were studied in healthy subjects and HIV-1-infected subjects.
Farmakokinetiko doravirina so proučevali pri zdravih osebah in preiskovancih, okuženih s HIV-1.
Doravirine has not been studied in patients with end-stage renal disease or in patients undergoing dialysis (see section 4.2).
Doravirin ni raziskan pri bolnikih s končno odpovedjo ledvic ali pri bolnikih na dializi (glejte poglavje 4.2).
In DRIVE-AHEAD, 728 subjects were randomized and received at least 1 dose of either doravirine/lamivudine/tenofovir disoproxil 100/300/245 mg (DOR/3TC/TDF) or efavirenz/emtricitabine/tenofovir disoproxil (EFV/FTC/TDF) once daily.
V preskušanju DRIVE-AHEAD je bilo randomiziranih 728 preiskovancev in prejeli so vsaj 1 odmerek bodisi kombinacije doravirin/lamivudin/dizoproksiltenofovirat 100/300/245 mg (DOR/3TC/TDF) bodisi efavirenz/emtricitabin/dizoproksiltenofovirat (EFV/FTC/TDF) enkrat na dan.
• increased levels of creatinine in your blood
• zvišanje koncentracije kreatinina v krvi
Very rare: may affect up to 1 in 10,000 people
Zelo redki: pojavijo se lahko pri največ 1 od 10.000 bolnikov:
Co-administration of doravirine with other moderate CYP3A inducers has not been evaluated, but decreased doravirine concentrations are expected.
Sočasna uporaba doravirina z drugimi zmernimi induktorji CYP3A ni ovrednotena, pričakuje pa se znižanje koncentracije doravirina.
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.
Pri vseh bolnikih s HIV-1 je treba pred uvedbo protiretrovirusnega zdravljenja opraviti testiranje prisotnosti virusa hepatitisa B (HBV).
Doravirine/lamivudine/tenofovir disoproxil should not be administered with doravirine unless needed for dose adjustment (e.g., with rifabutin) (see sections 4.2 and 4.5).
Kombinacije doravirin/lamivudin/dizoproksiltenofovirat se ne sme uporabljati z doravirinom, razen če je potrebna prilagoditev odmerka (npr. med jemanjem rifabutina) (glejte poglavji 4.2 in 4.5).
Single dose lamivudine oral solution 300 mg lamivudine
Enkratni odmerek peroralne raztopine 300 mg lamivudina lamivudin
See list under “Do not take Delstrigo” section.
Glejte seznam v poglavju "Ne jemljite zdravila Delstrigo".
• St. John's wort (Hypericum perforatum)
• šentjanževka (Hypericum perforatum),
• increased levels of amylase
• zvišanje amilaze
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.
Farmakokinetike tenofovirja niso raziskali pri preiskovancih z očistkom kreatinina < 10 ml/min, ki niso bili zdravljeni z dializo, in pri preiskovancih s končno odpovedjo ledvic, zdravljenih s peritonealno dializo ali drugimi oblikami dialize.
Antimycobacterials
Antimikobakterijska zdravila
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).
Uporaba enkratnega odmerka ene tablete kombinacije doravirin/lamivudin/dizoproksiltenofovirat pri zdravih osebah (N = 24) na tešče je dosegla enako izpostavljenost doravirinu, lamivudinu in tenofovirju kot sočasna uporaba tablet doravirina (100 mg), lamivudina (300 mg) in dizoproksiltenofovirata (245 mg).
Metabolism of lamivudine is a minor route of elimination.
Presnova je manj pomembna pot odstranjevanja lamivudina.
Serum parathyroid hormone levels and 1,25 Vitamin D levels were also higher in subjects receiving tenofovir disoproxil.
Prejemniki dizoproksiltenofovirata so imeli tudi višjo koncentracijo paratiroidnega hormona in 1,25 vitamina D v serumu.
Expected:  lisinopril
Pričakovano:  lizinopril
Table 2: Tabulated summary of adverse reactions associated with doravirine/lamivudine/tenofovir disoproxil
Preglednica 2: Povzetek neželenih učinkov, povezanih s kombinacijo doravirin/lamivudin/dizoproksiltenofovirat
In patients at risk of renal dysfunction, including patients who have previously experienced renal events while receiving adefovir dipivoxil, it is recommended that estimated CrCl, serum phosphorus, urine glucose, and urine protein be assessed prior to initiation of Delstrigo and more frequent renal function monitoring should be assessed as appropriate per the patient's medical condition during Delstrigo therapy.
Pri bolnikih s tveganjem za moteno delovanje ledvic, vključno z bolniki, ki so že kdaj imeli ledvične dogodke med prejemanjem dipivoksiladefovirata, je pred uvedbo zdravila Delstrigo priporočljivo določiti očistek kreatinina, fosfor v serumu, glukozo v urinu in beljakovine v urinu.
Doravirine has an estimated absolute bioavailability of approximately 64 % for the 100 mg tablet.
Ocenjena absolutna biološka uporabnost doravirina v 100-mg tabletah je približno 64 %.
One subject developed RT M184M/I mutation and phenotypic resistance to 3TC and FTC during treatment with their baseline regimen.
Pri enem preiskovancu sta se med zdravljenjem z izhodiščno shemo pojavili mutacija RT M184M/I in fenotipska odpornost proti 3TC in FTC.
Expected:  norgestimate/ethinyl oestradiol
Pričakovano:  norgestimat/etinilestradiol
• enlarged liver or fatty liver, yellow skin or eyes, pain in the belly (abdomen) caused by inflammation of the liver
• povečana jetra ali kopičenje maščobe v jetrih, rumena koža ali očesne beločnice, bolečine v trebuhu zaradi vnetja jeter
The antiviral activity of lamivudine against HIV-1 was assessed in a number of cell lines including monocytes and peripheral blood mononuclear cells (PBMCs) using standard susceptibility assays.
Protivirusno aktivnost lamivudina proti HIV-1 so s standardnimi preizkusi občutljivosti ocenili v številnih celičnih linijah, vključno z monociti in mononuklearnimi celicami periferne krvi.
For potential medicine product interactions with tenofovir disoproxil or lamivudine, (see sections 4.4 and 5.2).
Za možna medsebojna delovanja zdravil z dizoproksiltenofoviratom ali lamivudinom glejte poglavji 4.4 in 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.
Klinični izolati s substitucijo Y188L ali substitucijami V106 v kombinaciji z A98G, H221Y, P225H, F227C ali Y318F so imeli več kot 100-krat manjšo občutljivost za doravirin.
Metabolism and nutrition disorders Uncommon hypophosphataemia, hypokalaemia*
Presnovne in prehranske motnje Občasni hipofosfatemija, hipokaliemija*
• feeling sick (nausea), diarrhoea, stomach pain, vomiting, wind (flatulence)
• siljenje na bruhanje (navzea), driska, bolečine v trebuhu, bruhanje, vetrovi (napenjanje)
Rare blood creatine phosphokinase increased
Redki zvišanje kreatin-fosfokinaze v krvi
Doravirine/lamivudine/tenofovir disoproxil must not be co-administered with other medicinal products containing lamivudine, or with medicinal products containing tenofovir disoproxil, or tenofovir alafenamide, or with adefovir dipivoxil (see section 4.5).
Kombinacije doravirin/lamivudin/dizoproksiltenofovirat se ne sme uporabljati sočasno z drugimi zdravili, ki vsebujejo lamivudin, ali z zdravili, ki vsebujejo dizoproksiltenofovirat, tenofoviralafenamid ali dipivoksiladefovirat (glejte poglavje 4.5).
Nervous system disorders Common headache, dizziness, somnolence
Bolezni živčevja Pogosti glavobol, omotica, zaspanost
Very rare pure red cell aplasia*
Zelo redki čista aplazija eritrocitov*
The pharmacokinetic properties of lamivudine have been determined in subjects with moderate to severe hepatic impairment.
Farmakokinetične lastnosti lamivudina so proučevali pri preiskovancih z zmerno do hudo okvaro jeter.
• 1 bottle with 30 film-coated tablets
• 1 plastenka s 30 filmsko obloženimi tabletami
HIV-1 RNA < 40 copies/mL
HIV-1 RNA < 40 kopij/ml
HIV-1 RNA ≥ 40 copies/mL
HIV-1 RNA ≥ 40 kopij/ml
Lamivudine There are no significant or clinically relevant racial differences in pharmacokinetics of lamivudine.
Lamivudin V farmakokinetiki lamivudina ni značilnih ali klinično pomembnih rasnih razlik.
Long-term oral carcinogenicity studies of doravirine in mice and rats showed no evidence of carcinogenic potential at estimated exposures up to 6 times (mice) and 7 times (rats) the human exposures at the RHD.
Rezultati dolgoročnih študij kancerogenosti doravirina po peroralni uporabi pri miših in podganah niso pokazali znakov kancerogenega potenciala ob izpostavljenostih, ki so bile ocenjene na 6-krat (miši) oz. 7-krat (podgane) večje, kot je izpostavljenost pri človeku med uporabo RHD.