natgillin/translations-raw huggingface dataset:
• 90 filmovertrukne tabletter (3 flasker a 30 filmovertrukne tabletter).
• 90 film-coated tablets (3 bottles of 30 film-coated tablets)
Sjælden: kan forekomme hos op til 1 ud af 1.000 personer
Rare: may affect up to 1 in 1,000 people
Det kan være nødvendigt, at du får taget blodprøver i 4 måneder, efter at du er stoppet med behandlingen for at undersøge, hvordan din lever fungerer.
You may need blood tests to check how your liver is working for 4 months after stopping treatment.
• Hold flasken tæt tillukket for at beskytte mod fugt.
• Keep the bottle tightly closed in order to protect from moisture.
Forventet: ↑ tenofovir
Expected: ↑ tenofovir
• ledsmerter, nedbrydning af muskelvæv, muskelsvaghed
• joint pain, breakdown of muscle tissue, muscular weakness
• nafcillin (et lægemiddel til behandling af visse bakterieinfektioner)
• nafcillin (a medicine to treat some bacterial infections)
I DRIVE-FORWARD blev 766 forsøgspersoner randomiseret og fik mindst 1 dosis af enten doravirin 100 mg eller darunavir + ritonavir 800 mg + 100 mg en gang dagligt, hver i kombination med emtricitabin/tenofovirdisoproxil (FTC/TDF) eller abacavir/lamivudin (ABC/3TC) i henhold til investigators valg.
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.
Det tilrådes derfor at udvise forsigtighed, når doravirin/lamivudin/tenofovirdisoproxil administreres til patienter med svært nedsat leverfunktion (se pkt.
Therefore, caution is advised when doravirine/lamivudine/tenofovir disoproxil is administered to patients with severe hepatic impairment (see section 5.2).
Vaskulære sygdomme Ikke almindelig hypertension
Vascular disorders Uncommon hypertension
Debut eller forværring af nedsat nyrefunktion
New onset or worsening renal impairment
Enkeltdosis-administration af en doravirin/lamivudin/tenofovirdisoproxil-tablet til raske forsøgspersoner (n=24) i fastende tilstand gav eksponeringer for doravirin, lamivudin og tenofovir, der var sammenlignelige med eksponeringerne ved administration af doravirin-tabletter (100 mg) plus lamivudin-tabletter (300 mg) plus tenofovirdisoproxil-tabletter (245 mg).
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).
Tag altid lægemidlet nøjagtigt efter lægens, apotekspersonalets eller sygeplejerskens anvisning.
Always take this medicine exactly as your doctor, pharmacist, or nurse has told you.
Dette opnås ved at tilføje en 100 mg tablet doravirin (som enkeltstof), som skal tages ca. 12 timer efter dosis af Delstrigo (se pkt.
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).
Fase 3-studierne, DRIVE-FORWARD og DRIVE-AHEAD, inkluderede tidligere ubehandlede patienter (n=747), hvor følgende NNRTI-substitutioner var del af eksklusionskriterierne: 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 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.
Infektioner og parasitære sygdomme Sjælden pustuløst udslæt
Infections and infestations Rare rash pustular
• ledipasvir/sofosbuvir (lægemidler til behandling af hepatitis C-infektion)
• ledipasvir/sofosbuvir (medicines used to treat hepatitis C infection)
Hiv-1-isolater fra patienter (n=20), hvis hiv-1 udtrykte gennemsnitligt 3 zidovudin-associerede RT-aminosyresubstitutioner (M41L, D67N, K70R, L210W, T215Y/F eller K219Q/E/N), viste en 3,1 gange reduktion i følsomheden over for tenofovir.
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.
Ikke almindelig opmærksomhedsforstyrrelse, hukommelsesbesvær, paræstesi, hypertoni, dårlig søvnkvalitet
Uncommon disturbance in attention, memory impairment, paraesthesia, hypertonia, poor quality sleep
Det er ikke nødvendigt at justere dosis af doravirin/lamivudin/tenofovirdisoproxil hos patienter med let nedsat (Child-Pugh-klasse A) eller moderat nedsat (Child-Pugh-klasse B) leverfunktion.
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.
Lamivudin var ikke mutagent i en analyse af mikrobiel mutagenicitet, i en in vitro-celletransformationsanalyse, i en rottemikronukleusanalyse, i en cytogenetisk analyse af rotteknoglemarv og i en analyse for uplanlagt DNA-syntese i rottelever.
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.
• aggression, hallucinationer, besvær med at tilpasse sig forandringer, humørsvingninger,
• aggression, hallucinations, difficulty adjusting to changes, mood changes, sleep walking
Forventet:  doravirin ↑ tenofovir
Expected:  doravirine ↑ tenofovir
Dyreforsøg med doravirin indikerer hverken direkte eller indirekte skadelige virkninger, hvad angår reproduktionstoksicitet (se pkt.
Animal studies with doravirine do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Hos patienter med risiko for dysfunktion af nyrerne skal alternativer til NSAID overvejes, hvis det er nødvendigt.
Alternatives to NSAIDs should be considered, if needed, in patients at risk for renal dysfunction.
Undgå vedvarende anvendelse af doravirin/lamivudin/tenofovirdisoproxil sammen med sorbitolholdige lægemidler eller andre osmotisk virkende polyalkoholer (f.eks. xylitol, mannitol, lactitol, maltitol), når det er muligt.
When possible, avoid chronic co-administration of doravirine/lamivudine/tenofovir disoproxil with medicinal products containing sorbitol or other osmotic acting polyalcohols (e.g., xylitol, mannitol, lactitol, maltitol).
Det er ikke nødvendigt at justere dosis af Delstrigo hos voksne med en estimeret kreatininclearance (CrCl) på ≥ 50 ml/min.
No dose adjustment of Delstrigo is required in adults with estimated creatinine clearance (CrCl) ≥ 50 mL/min.
Knogleabnormiteter (i sjældne tilfælde med frakturer til følge) kan være forbundet med proksimal renal tubulopati.
Bone abnormalities (infrequently contributing to fractures) may be associated with proximal renal tubulopathy.
Det skal du vide, før du begynder at tage Delstrigo
What you need to know before you take Delstrigo
• vejrtrækningsproblemer, forstørrede mandler
• difficulty breathing, enlarged tonsils
Pædiatrisk population Delstrigos sikkerhed og virkning hos patienter under 18 år er ikke klarlagt.
Safety and efficacy of Delstrigo have not been established in patients younger than 18 years of age.
I DRIVE-AHEAD blev 728 forsøgspersoner randomiseret og fik mindst 1 dosis af enten doravirin/lamivudin/tenofovirdisoproxil 100/300/245 mg (DOR/3TC/TDF) eller efavirenz/emtricitabin/tenofovirdisoproxil (EFV/FTC/TDF) en gang dagligt.
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.
Sjælden hypomagnesiæmi, lactacidose*
Rare hypomagnesaemia, lactic acidosis*
• perikon (Hypericum perforatum)
• St. John's wort (Hypericum perforatum)
• doravirin - en non-nukleosid revers transkriptasehæmmer (NNRTI)
• Doravirine - a non-nucleoside reverse transcriptase inhibitor (NNRTI)
Doravirin er ikke undersøgt hos patienter med svært nedsat leverfunktion (Child-Pugh-klasse C).
Doravirine has not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Nervesystemet Almindelig hovedpine, svimmelhed, døsighed
Nervous system disorders Common headache, dizziness, somnolence
• lactacidose (for meget mælkesyre i blodet)
• lactic acidosis (excess lactic acid in the blood)
Hud og subkutane væv Almindelig alopeci*, udslæt
Skin and subcutaneous tissue disorders Common alopecia*, rash
Langtidskarcinogenicitetsstudier af oralt administreret doravirin hos mus og rotter viste ingen tegn på karcinogent potentiale ved estimerede eksponeringer op til 6 gange (mus) og 7 gange (rotter) eksponeringerne hos mennesker ved RHD.
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.
Sjælden aggression, hallucinationer, tilpasningsforstyrrelse, ændret stemningsleje, søvngængeri
Rare aggression, hallucination, adjustment disorder, mood altered, somnambulism
Sjælden akut nyreskade, nyresygdom, sten i urinvejene, nefrolitiasis, akut nyresvigt*, nyresvigt*, akut tubulær nekrose*, nefritis (herunder akut interstitiel)*, nefrogen diabetes insipidus* Almene symptomer og reaktioner på administrationsstedet Almindelig træthed, feber*
Rare acute kidney injury, renal disorder, calculus urinary, nephrolithiasis, acute renal failure*, renal failure*, acute tubular necrosis*, nephritis (including acute interstitial)*, nephrogenic diabetes insipidus*
Doravirin er ikke undersøgt hos patienter med terminal nyresygdom (ESRD) eller hos patienter i dialysebehandling (se pkt.
Doravirine has not been studied in patients with end-stage renal disease or in patients undergoing dialysis (see section 4.2).
Lamivudins farmakokinetiske egenskaber er blevet bestemt hos forsøgspersoner med moderat til svært nedsat leverfunktion.
The pharmacokinetic properties of lamivudine have been determined in subjects with moderate to severe hepatic impairment.
Der er rapporteret nedsat nyrefunktion, herunder tilfælde af akut nyresvigt og Fanconis syndrom (beskadigede nyretubuli med svær hypofosfatæmi), ved anvendelse af tenofovirdisoproxil, som er en komponent i Delstrigo.
Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphataemia), has been reported with the use of tenofovir disoproxil, a component of Delstrigo.
• hovedpine, svimmelhed, søvnighed
• headache, dizziness, sleepiness
K70E-substitutionen, der blev selekteret for ved klinisk anvendelse af tenofovirdisoproxil, resulterer i nedsat følsomhed over for abacavir, didanosin, emtricitabin, lamivudin og tenofovir.
The K70E substitution selected clinically by tenofovir disoproxil results in reduced susceptibility to abacavir, didanosine, emtricitabine, lamivudine, and tenofovir.
Doravirin Doravirin var ikke genotoksisk i en række in vitro- og in vivo-analyser.
Doravirine was not genotoxic in a battery of in vitro or in vivo assays.
Af klinisk relevans sås en reduktion i antallet af erytrocytter og neutropeni.
The clinically relevant effects noted were a reduction in red blood cell count and neutropenia.
Ikke almindelig mareridt, depression 2, angst 3, irritabilitet,
Uncommon nightmare, depression 2, anxiety 3, irritability, confusional state, suicidal ideation
NNRTIsubstitutioner, der var del af eksklusionskriterierne, er angivet i afsnittet om resistens.
Refer to Resistance section for NNRTI substitutions that were part of exclusion criteria.
Samtidig administration af doravirin og andre moderate CYP3A-induktorer er ikke blevet vurderet, men der forventes en nedsat koncentration af doravirin.
Co-administration of doravirine with other moderate CYP3A inducers has not been evaluated, but decreased doravirine concentrations are expected.
Kliniske isolater med Y188L-substitution eller V106-substitutioner i kombination med A98G, H221Y, P225H, F227C eller Y318F viste en større end 100 gange reduktion i følsomhed over for doravirin.
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.
Hvis du er i tvivl, så kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Delstrigo.
If you are not sure, talk to your doctor, pharmacist, or nurse before taking Delstrigo.
Hypofosfatæmi og osteomalaci sekundært til proksimal renal tubulopati skal overvejes hos patienter med risiko for dysfunktion af nyrerne, som oplever persisterende eller tiltagende knogle- eller muskelsymptomer, mens de får lægemidler, der indeholder tenofovirdisoproxil (se pkt.
Hypophosphataemia and osteomalacia secondary to proximal renal tubulopathy should be considered in patients at risk of renal dysfunction who present with persistent or worsening bone or muscle symptoms while receiving products containing tenofovir disoproxil (see section 4.4).
• forhøjet af indhold af kreatinfosfokinase.
• increased levels of creatine phosphokinase
+ T-celletal på < 200 celler pr. mm
+ T cell count < 200 cells per mm
Dyreforsøg med tenofovirdisoproxil indikerer hverken direkte eller indirekte skadelige virkninger af tenofovirdisoproxil, hvad angår reproduktionstoksicitet (se pkt.
Animal studies with tenofovir disoproxil do not indicate direct or indirect harmful effects of tenofovir disoproxil with respect to reproductive toxicity (see section 5.3).
Etiket til tabletflaske
Bottle label
På baggrund af in vitro-data metaboliseres doravirin primært via CYP3A.
Biotransformation Based on in vitro data, doravirine is primarily metabolised by CYP3A.
Forventet:  doravirin
Expected:  doravirine
Sjælden forhøjet kreatinfosfokinase i blodet
Rare blood creatine phosphokinase increased
Meget sjælden ren erytrocyt aplasi*
Very rare pure red cell aplasia*
Doravirins farmakokinetik blev undersøgt hos raske forsøgspersoner og hiv-1-inficerede forsøgspersoner.
The pharmacokinetics of doravirine were studied in healthy subjects and HIV-1-infected subjects.
DOR eller kontrol (DRV eller EFV)
Successful genotype, n Genotypic resistance to DOR or control (DRV or EFV) 2 (DOR)
Forventet:  norgestimat/ethinylestradiol
Expected:  norgestimate/ethinyl oestradiol
Dosisjustering er ikke nødvendig hos patienter med let nedsat eller moderat nedsat leverfunktion.
No dose adjustment is required in patients with mild or moderate hepatic impairment.
• brystsmerter, kuldefølelse, smerter, tørst.
• pain in the chest, feeling cold, pain, thirst
Derudover er en K70Esubstitution i hiv-1-RT blevet selekteret for ved anvendelse af tenofovir, som resulterer i, at følsomheden over for abacavir, emtricitabin, lamivudin og tenofovir nedsættes i mindre grad.
In addition, a K70E substitution in HIV-1 RT has been selected by tenofovir and results in low-level reduced susceptibility to abacavir, emtricitabine, lamivudine, and tenofovir.
Patienter med moderat eller svært nedsat nyrefunktion kræver en trinvis dosisjustering af lamivudin og tenofovirdisoproxil, der ikke er mulig med kombinationstabletten (se pkt.
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).
Hvis administration sammen med andre moderate CYP3A-induktorer (f.eks. dabrafenib, lesinurad, bosentan, thioridazin, nafcillin, modafinil, telotristatethyl) ikke kan undgås, skal en 100 mg tablet doravirin tages dagligt ca. 12 timer efter Delstrigo (se pkt.
If co-administration with other moderate CYP3A inducers (e.g., dabrafenib, lesinurad, bosentan, thioridazine, nafcillin, modafinil, telotristat ethyl) cannot be avoided, one 100 mg tablet of doravirine should be taken daily, approximately 12 hours after the dose of Delstrigo (see section 4.5).
Hvis din næste dosis imidlertid skal tages inden for 12 timer, så spring den glemte dosis over, og tag den næste dosis på det sædvanlige tidspunkt.
12 hours, skip the dose you missed and take the next one at the usual time.
Dosisjustering er ikke nødvendig hos patienter med let nedsat, moderat nedsat eller svært nedsat nyrefunktion.
No dose adjustment is required in patients with mild, moderate or severe renal impairment.
Doravirin udviste antiviral aktivitet mod et bredt panel af primære hiv-1-isolater (A, A1, AE, AG, B, BF, C, D, G, H) med EC50-værdier fra 1,2 nM til 10,0 nM. Doravirins antivirale aktivitet var ikke antagonistisk ved kombination med lamivudin og tenofovirdisoproxil.
Doravirine demonstrated antiviral activity against a broad panel of primary HIV-1 isolates (A, A1, AE, AG, B, BF, C, D, G, H) with EC50 values ranging from 1.2 nM to 10.0 nM.
I et studie af peri- og postnatal toksicitet reducerede tenofovirdisoproxil imidlertid levedygtighedsindekset og vægten hos afkom ved maternelt toksiske doser.
However, tenofovir disoproxil reduced the viability index and weight of pups in a peri-postnatal toxicity study at maternally toxic doses.
Der er ikke klarlagt et breakpoint for reduktion i følsomhed forårsaget af forskellige NNRTI-substitutioner, der er forbundet med reduktion i klinisk virkning (se pkt.
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).
Samtidig administration af doravirin/lamivudin/tenofovirdisoproxil og lægemidler, der er CYP3Ahæmmere, kan resultere i en øget plasmakoncentration af doravirin.
Co-administration of doravirine/lamivudine/tenofovir disproxil and medicinal products that are inhibitors of CYP3A may result in increased plasma concentrations of doravirine.
Doravirin/lamivudin/tenofovirdisoproxil må ikke administreres sammen med lægemidler, der er potente CYP3A-enzyminduktorer, da der forventes at forekomme et signifikant fald i plasmakoncentrationen af doravirin, hvilket kan nedsætte doravirin/lamivudin/tenofovirdisoproxils virkning (se pkt.
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).
Alle patienter med hiv-1 skal testes for tilstedeværelse af hepatitis B-virus (hbv), før antiretroviral behandling initieres.
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.
2.185 (12%) ng·t/ml hos forsøgspersoner med CrCl > 80 ml/min til henholdsvis 3.064 (30%) ng·t/ml, 6.009 (42%) ng·t/ml og 15.985 (45%) ng·t/ml hos forsøgspersoner med let nedsat, moderat nedsat og svært nedsat nyrefunktion.
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.
Doravirin/lamivudin/tenofovirdisoproxil må ikke administreres sammen med andre lægemidler, der indeholder lamivudin, eller sammen med lægemidler, der indeholder tenofovirdisoproxil eller tenofoviralafenamid, eller sammen med adefovirdipivoxil (se pkt.
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).
I in vitro-studier var doravirin ved klinisk relevante koncentrationer i stand til at undertrykke følgende NNRTI-associerede substitutioner: K103N, Y181C og G190A.
In in vitro studies, doravirine was able to suppress the following NNRTI-associated substitutions; K103N, Y181C, and G190A under clinically relevant concentrations.
I en in vivo-musemikronukleusanalyse var tenofovirdisoproxil negativt, når det blev administreret til hanmus.
In an in vivo mouse micronucleus assay, tenofovir disoproxil was negative when administered to male mice.
Indvirkning på lægemiddelniveauer Geometrisk gennemsnitsratio (90% CI)*
Geometric Mean Ratio (90 % CI)*
Tabel 2: Tabel over bivirkninger associeret med doravirin/lamivudin/tenofovirdisoproxil
Table 2: Tabulated summary of adverse reactions associated with doravirine/lamivudine/tenofovir disoproxil
Doravirin/lamivudin/tenofovirdisoproxil må ikke administreres sammen med doravirin, medmindre det er nødvendigt for dosisjustering (f.eks. med rifabutin) (se pkt.
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).
Andre lægemidlers indvirkning på doravirin, lamivudin og tenofovirdisoproxil
Effects of other medicinal products on doravirine, lamivudine, and tenofovir disoproxil Doravirine
Autoimmune sygdomme (f.eks. Graves sygdom, autoimmun hepatitis, polymyositis og Guillain-Barrés syndrom) er også rapporteret at forekomme ved immunreaktivering.
Autoimmune disorders (such as Graves' disease, autoimmune hepatitis, polymyositis, and GuillainBarré syndrome) have also been reported to occur in the setting of immune reactivation; however, the time to onset is more variable and can occur many months after initiation of treatment.
Syrereducerende midler antacidum (aluminium- og magnesiumhydroxid, oral suspension) (20 ml enkeltdosis, doravirin 100 mg enkeltdosis)
Acid-Reducing Agents antacid (aluminium and magnesium hydroxide oral suspension) (20 mL SD, doravirine 100 mg SD)
• træthedsfølelse, feber.
• feeling tired, fever
Delstrigo virker ved at hæmme hiv-virusets evne til at formere sig (lave kopier af sig selv) i kroppen.
Delstrigo works by preventing HIV from making more viruses in your body.
Delstrigo 100 mg / 300 mg / 245 mg filmovertrukne tabletter doravirin/lamivudin/tenofovirdisoproxil
Delstrigo 100 mg / 300 mg / 245 mg film-coated tablets doravirine/lamivudine/tenofovir disoproxil
Doravirin, lamivudin og tenofovirdisoproxils indvirkning på andre lægemidler
Effects of doravirine, lamivudine, and tenofovir disoproxil on other medicinal products Doravirine
Delstrigo skal seponeres, hvis den estimerede CrCl falder til under 50 ml pr. minut (se pkt.
Delstrigo should be discontinued if estimated CrCl declines below 50 mL per minute (see section 4.4).
Ikke almindelig myalgi, artralgi, rabdomyolyse* muskelsvaghed*
Uncommon myalgia, arthralgia, rhabdomyolysis* muscular weakness*
Observerede aminosyresubstitutioner i RT omfattede: V106A, V106M, V106I, V108I, F227L, F227C, F227V, H221Y, M230I, L234I, P236L og Y318F.
Observed emergent amino acid substitutions in RT included: V106A, V106M, V106I, V108I, F227L, F227C, F227V, H221Y, M230I, L234I, P236L, and Y318F.
Forventet:  doravirin ↓ tacrolimus, sirolimus (CYP3A-induktion)
Expected:  doravirine ↓ tacrolimus, sirolimus (Induction of CYP3A)
Croscarmellosenatrium (E468) Hypromelloseacetatsuccinat Magnesiumstearat (E470b) Mikrokrystallinsk cellulose (E460) Silica, kolloid vandfri (E551) Natriumstearylfumarat
Croscarmellose sodium (E468) Hypromellose acetate succinate Magnesium stearate (E470b) Microcrystalline cellulose (E460) Silica, colloidal anhydrous (E551) Sodium stearyl fumarate
Tenofovirdifosfat er en svag hæmmer af DNA-polymerase α, ß og mitokondrie-DNA-polymerase γ hos pattedyr.
Tenofovir diphosphate is a weak inhibitor of mammalian DNA polymerases α, β, and mitochondrial DNA polymerase γ.