FrancophonIA/ELRC3.0 huggingface dataset:
English: Because tenofovir is primarily eliminated by the kidneys through a combination of glomerular filtration and active tubular secretion (see section 5.2), co-administration of doravirine/lamivudine/tenofovir disoproxil with medicinal products that reduce renal function or compete for active tubular secretion via OAT1, OAT3 or MRP4 may increase serum concentrations of tenofovir.
Icelandic: Þar sem tenofovir skilst aðallega út um nýru bæði með gaukulsíun og virkri pípluseytingu (kafli 5.2) getur samhliða gjöf doravirin/lamivudin/tenofovir disoproxils og lyfja sem draga úr nýrnastarfsemi eða keppa um virka pípluseytingu fyrir tilstilli OAT1, OAT3 eða MRP4 aukið sermisþéttni tenofovirs.
English: Expected: ↑ tenofovir
Icelandic: Áætlað: ↑ tenofovir
English: In humans, the only known metabolite is the trans-sulphoxide metabolite (approximately 5 % of an oral dose after 12 hours).
Icelandic: Hjá mönnum er eina þekkta umbrotsefnið trans-sulfoxíð (u.þ.b.
English: Pharmacotherapeutic group: Antivirals for systemic use, ATC code: J05AR24
Icelandic: Veirulyf til altækrar notkunar (systemic use), ATC-flokkur:
English: rifabutin (300 mg QD, doravirine 100 mg SD)
Icelandic: rifabutin (300 mg QD, doravirin 100 mg SD)
English: The bone toxicity in young adult rats and dogs occurred at exposures ≥ 5-fold the exposure in paediatric or adult patients; bone toxicity occurred in juvenile infected monkeys at very high exposures following subcutaneous dosing (≥ 40-fold the exposure in patients).
Icelandic: Eiturverkun á bein hjá ungum fullvöxnum rottum og hundum varð við útsetningu sem samsvarar ≥ 5-faldri útsetningu hjá börnum og ungum sjúklingum.
English: Merck Sharp & Dohme Cyprus Limited Τηλ.
Icelandic: Malta Merck Sharp & Dohme Cyprus Limited
English: The oral bioavailability of tenofovir from tenofovir disoproxil in fasted subjects is approximately 25 %.
Icelandic: Aðgengi tenofovirs frá tenofovir disoproxili eftir inntöku hjá fastandi einstaklingum er u.þ.b. 25 %.
English: Immune reactivation syndrome has been reported in patients treated with combination antiretroviral therapy.
Icelandic: Greint hefur verið frá ónæmisendurvirkjunarheilkenni hjá sjúklingum sem hafa fengið samsetta andretróveirumeðferð.
English: • It is important that you do not miss or skip doses of Delstrigo.
Icelandic: Mikilvægt er að sleppa ekki úr skammti af Delstrigo
English: Oral carcinogenicity studies in rats and mice only revealed a low incidence of duodenal tumours at an extremely high-dose in mice.
Icelandic: Rannsóknir á krabbameinsvaldandi áhrifum eftir inntöku eingöngu hjá rottum og músum gaf til kynna lága tíðni skeifugarnaæxla við óhemju stóra skammta hjá músum.
English: Tenofovir diphosphate is a weak inhibitor of mammalian DNA polymerases α, β, and mitochondrial DNA polymerase γ.
Icelandic: Tenofovir difosfat er vægur hemill DNA polymerasa α, ß, og hvatbera DNA polymerasa γ í mannafrumum.
English: Each film-coated tablet contains 100 mg of doravirine, 300 mg of lamivudine, and 300 mg of tenofovir disoproxil fumarate equivalent to 245 mg of tenofovir disoproxil.
Icelandic: Hver filmuhúðuð tafla inniheldur 100 mg doravirin, 300 mg lamivudin og 300 mg tenofovir disoproxil fumarat sem jafngildir 245 mg tenofovir disoproxil.
English: + T'.
Icelandic: DOR +
English: 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).
Icelandic: Tenofovir skilst út með gaukulsíun og virkri pípluseytingu með nýrnaúthreinsun 243,5 ± 33,3 ml/mín.
English: rifapentine
Icelandic: rifapentin
English:  R-methadone AUC 0.95 (0.90, 1.01) Cmax 0.98 (0.93, 1.03) C24 0.95 (0.88, 1.03)
Icelandic:  R-methadon AUC 0,95 (0,90; 1,01) Cmax 0,98 (0,93; 1,03) C24 0,95 (0,88; 1,03)
English: Based on administration of an IV microdose, the volume of distribution of doravirine is 60.5 L. Doravirine is approximately 76 % bound to plasma proteins.
Icelandic: Doravirin er u.þ.b. 76 % bundið plasmapróteinum.
English: Doravirine pharmacokinetics are similar in healthy subjects and HIV-1-infected subjects.
Icelandic: Lyfjahvörf doravirins eru svipuð hjá heilbrigðum og þeim sem eru sýktir með HIV-1.
English: Geometric Mean Ratio (90 % CI)*
Icelandic: Áhrif á lyfjaþéttni Hlutfall margfeldismeðaltals (90 % CI)*
English: 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.
Icelandic: HIV-1 stofnar sem valdir voru af tenofovir tjá K65R í HIV-1 bakrita og sýndu
English: Rare rectal tenesmus
Icelandic: Æðar Sjaldgæfar háþrýstingur
English: 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.
Icelandic: Þar sem óverulegt magn lamivudins var fjarlægt með (4 klst.) blóðskilun, kviðskilun með pokaskiptum og sjálfvirkri kviðskilun er ekki vitað hvort ávinningur sé af blóðskilun með pokaskiptum við ofskömmtun lamivudins.
English: pantoprazole (40 mg QD, doravirine 100 mg SD)
Icelandic: pantoprazol (40 mg QD, doravirin 100 mg SD)
English: 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).
Icelandic: Íhuga á blóðfosfatlækkun og beinmeyru sem afleiðingar af aðlægum píplukvilla í nýrum hjá sjúklingum sem eru í hættu á truflun á nýrnastarfsemi með þrálát eða versnandi einkenni í beinum og vöðvum meðan á töku lyfja sem innihalda tenofovir disoproxil stendur (sjá kafla 4.4).
English: Check with your doctor, pharmacist, or nurse if you are not sure.
Icelandic: - Leitið til læknisins, lyfjafræðings eða hjúkrunarfræðingsins ef þörf er á frekari upplýsingum.
English: If you stop taking Delstrigo
Icelandic: Ef hætt er að nota Delstrigo
English: Information regarding potential medicinal product interactions with other antiretroviral medicines is not provided.
Icelandic: Upplýsingar um hugsanlega milliverkanir við önnur andretróveirulyf eru ekki fyrir hendi.
English: Uncommon asthenia, malaise
Icelandic: Sjaldgæfar martraðir, þunglyndi
English: *For Week 96, certain subjects with missing HIV-1 RNA were excluded from the analysis.
Icelandic: *Í viku 96 vantaði HIV-1
English: Co-administration of doravirine with other moderate CYP3A inducers has not been evaluated, but decreased doravirine concentrations are expected.
Icelandic: Samhliða gjöf doravirins og annarra meðalöflugra CYP3A virkja hefur ekki verið metin en búast má við minnkaðri doravirin þéttni.
English: Emergent doravirine associated resistance substitutions in RT included one or more of the following: A98G, V106I, V106A, V106M/T, Y188L, H221Y, P225H, F227C, F227C/R, and Y318Y/F.
Icelandic: A98G, V106I, V106A, V106M/T, Y188L, H221Y, P225H, F227C, F227C/R og Y318Y/F.
English: 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
Icelandic: Við upphaf var miðgildi aldurs 31 ár (á bilinu 18-70 ár), 85 % voru karlar, 52% voru ekki hvítir, 3% voru einnig með lifrarbólgu
English: • feeling weak, general feeling of being unwell
Icelandic: • almennur slappleiki, almenn vanlíðan
English: lamivudine + tenofovir disoproxil (300 mg lamivudine SD + 245 mg tenofovir disoproxil SD, doravirine 100 mg SD)
Icelandic: Ráðleggingar um gjöf samhliða doravirin/lamivudin/tenofovir disoproxili lamivudin + tenofovir disoproxil (300 mg Lamivudin SD + 245 mg tenofovir disoproxil SD, doravirin 100 mg SD)
English: Delstrigo 100 mg / 300 mg / 245 mg film-coated tablets doravirine/lamivudine/tenofovir disoproxil
Icelandic: Delstrigo 100 mg/ 300 mg / 245 filmuhúðaðar töflur doravirin/lamivudin/tenofovir disoproxil
English: If Delstrigo is stopped your doctor may recommend that you resume hepatitis B treatment.
Icelandic: Ef hætt er að taka Delstrigo getur verið að læknirinn ráðleggi þér að byrja aftur á meðferð við lifrarbólgu B. Þá gæti þurft að taka blóðpróf til þess að athuga hvernig lifrin starfar í 4 mánuði eftir að meðferð hefur verið hætt.
English: Skin and subcutaneous tissue disorders Common alopecia*, rash
Icelandic: Húð og undirhúð Algengar hármissir*, útbrot
English: The following de novo resistance was seen in the resistance analysis subset (subjects with HIV-1 RNA greater than 400 copies per mL at virologic failure or at early study discontinuation and having resistance data).
Icelandic: Eftirfarandi nýtilkomið ónæmi sást hjá undirhóp við ónæmisgreiningu (þeir sem voru með yfir 400 eintök/ml HIV-1
English: 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.
Icelandic: Greint hefur verið frá skertri nýrnastarfsemi m.a. bráðri nýrnabilun og Fanconi heilkenni (pípluskaði með verulegri blóðfosfatlækkun) við notkun tenofovir disoproxils sem er einn af þáttum Delstrigo.
English: Other medicines and Delstrigo
Icelandic: Notkun annarra lyfja samhliða Delstrigo
English: No clinically relevant differences in tenofovir pharmacokinetics were observed between subjects with hepatic impairment and healthy subjects.
Icelandic: Enginn klínískt verulegur munur er á lyfjahvörfum tenofovirs hjá einstaklingum sem eru með skerta lifrarstarfsemi og heilbrigðum einstaklingum.
English: 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.
Icelandic: Ef sjúklingur gleymir Delstrigo skammti lengur en í 12 klst.
English: The pharmacokinetics of doravirine were studied in healthy subjects and HIV-1-infected subjects.
Icelandic: Lyfjahvörf doravirins voru rannsökuð hjá heilbrigðum þátttakendum og einstaklingum sýktum með HIV-1.
English: No clinically relevant pharmacokinetic differences have been identified between men and women for doravirine, lamivudine, and tenofovir.
Icelandic: Enginn klínískt marktækur munur er á lyfjahvörfum doravirins, lamivudins og tenofovirs hjá körlum og konum.
English: Expected:  doravirine (Inhibition of CYP3A due to ritonavir)
Icelandic: doravirin (CYP3A hömlun vegna ritonavirs)
English: Medicinal Product by Therapeutic Area
Icelandic: Lyf eftir meðferðarsviði
English: 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).
Icelandic: Dýrarannsóknir benda hvorki til beinna né óbeinna skaðlegra áhrifa tenofovir disoproxils á æxlun (sjá kafla 5.3).
English: Arthralgias and muscle pain or weakness have also been reported in cases of proximal renal tubulopathy.
Icelandic: Einnig hefur verið greint frá liðverkjum og vöðvaverkjum eða -slappleika þegar um aðlægan píplukvilla í nýrum er að ræða.
English: New onset or worsening renal impairment
Icelandic: Nýtilkomin eða versnun nýrnaskerðingar
English: Rare musculoskeletal pain, osteomalacia (manifested as bone pain and infrequently contributing to fractures)*, myopathy*
Icelandic: Mjög sjaldgæfar stoðkerfisverkir, beinmeyra (einkennist af beinverkjum og sjaldan beinbrotum)*, vöðvakvilli*
English: lamivudine AUC 0.94 (0.88, 1.00) Cmax 0.92 (0.81, 1.05)
Icelandic: lamivudin AUC 0,94 (0,88; 1,00) Cmax 0,92 (0,81; 1,05)
English: Cystic Fibrosis Treatment lumacaftor
Icelandic: Til meðferðar á slímsseigjusjúkdómi lumacaftor
English: Cases of osteomalacia associated with proximal renal tubulopathy, manifested as bone pain or pain in extremities and which may contribute to fractures, have been reported in association with the use of tenofovir disoproxil .
Icelandic: Greint hefur verið frá beinmeyru sem tengist aðlægum píplukvilla í nýrum sem einkennist af beinverkjum eða verkjum í útlimum og sem getur leitt til beinbrota í tengslum við notkun tenofovir disoproxils.
English: Patients receiving doravirine/lamivudine/tenofovir disoproxil concomitantly with sofosbuvir/velpatasvir should be monitored for adverse reactions associated with tenofovir disoproxil.
Icelandic: Fylgjast á með sjúklingum sem fá doravirin/lamivudin/tenofovir disoproxil samhliða sofosbuvir/velpatasvir m.t.t. aukaverkana í tengslum við tenofovir disoproxil.
English: Acid-Reducing Agents antacid (aluminium and magnesium hydroxide oral suspension) (20 mL SD, doravirine 100 mg SD)
Icelandic: Sýrulækkandi lyf sýrubindandi lyf (ál og magnesiumhýdroxíð mixtúra, dreifa) (20 ml SD, doravirin 100 mg SD)
English: Lamivudine is a nucleoside analogue.
Icelandic: Lamivudin er núkleósíðhliðstæða.
English: • decreased levels of haemoglobin
Icelandic: • minnkað magn hemóglóbíns
English: Bone abnormalities (infrequently contributing to fractures) may be associated with proximal renal tubulopathy.
Icelandic: Afbrigðileiki í beinum (sem veldur sjaldan beinbrotum) getur tengst aðlægum píplukvilla í nýrum.
English: Merck Sharp & Dohme Cyprus Limited Tel: 8007 4433 (+356 99917558) malta_info@merck.com
Icelandic: Merck Sharp & Dohme Cyprus Limited Τηλ.: 800 00 673 (+357 22866700) cyprus_info@merck.com
English: HIV-1 RNA copies/mL
Icelandic: RNA eintök/ml
English: Because lamivudine is primarily eliminated by the kidneys through a combination of glomerular filtration and active tubular secretion (see section 5.2), co-administration of doravirine/lamivudine/tenofovir disoproxil with medicinal products that reduce renal function or compete for active tubular secretion may increase serum concentrations of lamivudine.
Icelandic: Þar sem lamivudin skilst aðallega út um nýru bæði með gaukulsíun og virkri pípluseytingu (kafli 5.2) getur samhliða gjöf doravirin/lamivudin/tenofovir disoproxils og lyfja sem draga úr nýrnastarfsemi eða keppa um virka pípluseytingu aukið sermisþéttni lamivudins.
English: How to store Delstrigo
Icelandic: Hvernig geyma á Delstrigo
English: • The active substances are 100 mg of doravirine, 300 mg of lamivudine and 245 mg of tenofovir disoproxil (as fumarate)
Icelandic: - Virku innihaldsefnin eru 100 mg af doravirini, 300 mg af lamivudini og 245 mg af tenofovir disoproxili (sem fumarat).
English: Patients receiving doravirine/lamivudine/tenofovir disoproxil concomitantly with ledipasvir/sofosbuvir should be monitored for adverse reactions associated with tenofovir disoproxil.
Icelandic: Fylgjast á með sjúklingum sem fá doravirin/lamivudin/tenofovir disoproxil samhliða ledipasvir/sofosbuvir m.t.t. aukaverkana í tengslum við tenofovir disoproxil.
English: Each film-coated tablet contains 100 mg of doravirine, 300 mg of lamivudine and 245 mg of tenofovir disoproxil.
Icelandic: Hver filmuhúðuð tafla inniheldur 100 mg doravirin, 300 mg lamivudin og 245 mg tenofovir disoproxil.
English:  doravirine AUC 0.95 (0.80, 1.12) Cmax 0.80 (0.64, 1.01) C24 0.94 (0.78, 1.12)
Icelandic:  doravirin AUC 0,95 (0,80; 1,12) Cmax 0,80 (0,64; 1,01) C24 0,94 (0,78; 1,12)
English: Ritonavir- or Cobicistat- boosted PI
Icelandic: Ritonavir- eða cobicistat-örvaður próteasahemill
English: Angiotensin Converting Enzyme Inhibitors lisinopril
Icelandic: ACE hemlar lisinopril
English: Expected:  doravirine ↑ tenofovir
Icelandic: Áætlað:  doravirin ↑ tenofovir
English:  doravirine AUC 1.01 (0.92, 1.11) Cmax 0.86 (0.74, 1.01) C24 1.03 (0.94, 1.12)
Icelandic:  doravirin AUC 1,01 (0,92; 1,11) Cmax 0,86 (0,74; 1,01) C24 1,03 (0,94; 1,12)
English:  S-methadone AUC 0.98 (0.90, 1.06) Cmax 0.97 (0.91, 1.04) C24 0.97 (0.86, 1.10)
Icelandic:  S-methadon AUC 0,98 (0,90; 1,06) Cmax 0,97 (0,91; 1,04) C24 0,97 (0,86; 1,10)
English: Lamivudine has been identified in breast-fed newborns/infants of treated women.
Icelandic: Lamivudin hefur greinst hjá brjóstmylkingum mæðra sem hafa fengið meðferð.
English: Rare aggression, hallucination, adjustment disorder, mood altered, somnambulism
Icelandic: Mjög sjaldgæfar árásarhneigð, ofskynjanir, aðlögunarröskun, geðsveiflur, svefnganga
English:  doravirine AUC 0.91 (0.78, 1.06) Cmax 1.40 (1.21, 1.63) C24 0.90 (0.80, 1.01)
Icelandic:  doravirin AUC 0,91 (0,78; 1,06) Cmax 1,40 (1,21; 1,63) C24 0,90 (0,80; 1,01)
English: Doravirine steady state pharmacokinetics following administration of 100 mg once daily to HIV-1 infected subjects, based on a population pharmacokinetics analysis are provided below.
Icelandic: Lyfjahvörf doravirins við jafnvægi hjá einstaklingum sýktum með HIV-1 eftir gjöf 100 mg einu sinni á dag byggt á þýðisgreiningu á lyfjahvörfum eru sýnd hér á eftir.
English: Rare blood creatine phosphokinase increased
Icelandic: Mjög sjaldgæfar aukinn kreatínkínasi í blóði
English:  doravirine AUC 0.96 (0.87, 1.06) Cmax 0.97 (0.88, 1.07) C24 0.94 (0.83, 1.06)
Icelandic:  doravirin AUC 0,96 (0,87; 1,06) Cmax 0,97 (0,88; 1,07) C24 0,94 (0,83; 1,06)
English: Some patients required hospitalisation and renal replacement therapy.
Icelandic: Sjúkrahúsinnlögn getur verið nauðsynleg hjá sumum sjúklingum ásamt nýrnauppbótarmeðferð.
English: Refer to Resistance section for NNRTI substitutions that were part of exclusion criteria.
Icelandic: RNA gildi hjá ákveðnum þátttakendum sem voru útilokaðir frá greiningunni.
English: 5, abdominal distension, dyspepsia, faeces soft gastrointestinal motility disorder
Icelandic: 5, þaninn kviður, meltingartruflanir, linar hægðir
English: Uncommon disturbance in attention, memory impairment, paraesthesia, hypertonia, poor quality sleep
Icelandic: Sjaldgæfar athyglisbrestur, minnisskerðing, náladofi, ofspenna, lélegur svefn
English:  doravirine
Icelandic: Doravirin
English: Uncommon nightmare, depression 2, anxiety 3, irritability, confusional state, suicidal ideation
Icelandic: • martraðir, þunglyndi, kvíði, skapstyggð, rugl, sjálfsvígshugsanir
English: Psychiatric disorders Common abnormal dreams, insomnia
Icelandic: Algengar óeðlilegir draumar, svefnleysi
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
Icelandic: Verkunarniðurstöður eru sýndar í töflu
English: Antidiabetics metformin (1000 mg SD, doravirine 100 mg QD)
Icelandic: Sykursýkilyf metformin (1.000 mg SD, doravirin 100 mg QD)
English: • decreased number of white blood cells in your blood (neutropenia)
Icelandic: • fækkun hvítra blóðfrumna (daufkyrningafæð)
English: HIV-1 RNA ≥ 40 copies/mL
Icelandic: ≥ 200 frumur/mm HIV-1 RNA ≥
English: Endothelin Receptor Antagonists bosentan
Icelandic: Æðaþelsviðtakablokkar bosentan
English: Respiratory, thoracic and mediastinal disorders Common cough*, nasal symptoms*
Icelandic: Öndunarfæri, brjósthol og miðmæti Algengar hósti*, einkenni frá nefi*
English: Vascular disorders Uncommon hypertension
Icelandic: Linar hægðir ná yfir: linar hægðir og óeðlilegar hægðir
English: Multiple dose rifampicin (600 mg QD, doravirine 100 mg SD)
Icelandic: Endurteknir skammtar af rifampini (600 mg QD, doravirin 100 mg SD)
English: Single dose rifampicin (600 mg SD, doravirine 100 mg SD)
Icelandic: Stakur skammtur rifampin (600 mg SD, doravirin 100 mg SD)
English: In a population pharmacokinetic analysis, which included subjects with CrCl between 17 and 317 mL/min, renal function did not have a clinically relevant effect on doravirine pharmacokinetics.
Icelandic: Í þýðisgreiningu á lyfjahvörfum sem tók til einstaklinga með CrCl á bilinu 17 og 317 ml/mín.
English: • headache, dizziness, sleepiness
Icelandic: Algengar ógleði, niðurgangur, kviðverkur
English: Expected:  buprenorphine  naloxone
Icelandic: Áætlað: ↔ buprenorphin ↔ naloxone
English: If co-administration cannot be avoided, a 100 mg dose of doravirine should be taken daily, 12 h after the dose of doravirine/lamivudine/tenofovir disoproxil.
Icelandic: Ef samhliða gjöf er óhjákvæmileg á að taka 100 mg af doravirini daglega u.þ.b. 12 klst. eftir skammt doravirin/lamivudin/tenofovir disoproxils.
English: The pharmacokinetic properties of lamivudine have been determined in subjects with moderate to severe hepatic impairment.
Icelandic: Lyfjahvörf lamivudins hafa ekki verið ákvörðuð hjá einstaklingum sem eru með meðalskerta eða alvarlega skerta lifrarstarfsemi.
English: • This medicinal product does not require any special temperature storage conditions.
Icelandic: - Ekki þarf að geyma lyfið við sérstök hitaskilyrði.
English: Discontinued study for Other Reasons
Icelandic: Hætt í rannsókn vegna aukaverkana eða dauðsfalls Hætt í rannsókn vegna annarra ástæðna Í rannsókninni, en upplýsingar vantar
English: The highest frequency category reported in the 3TC or TDF Summary of Product Characteristics is used.
Icelandic: Notast er við hæsta tíðniflokk úr samantekt á eiginleikum lyfs fyrir 3TC eða TDF.
English: 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.
Icelandic: 48 í DRIVE-SHIFT rannsókninni var sýnt fram á að tafarlaus skipti í Delstrigo voru ekki lakari en að halda áfram grunnmeðferð fram að viku
English: • Lamivudine - a nucleoside analogue reverse transcriptase inhibitor (NRTI)
Icelandic: Lamivudin - nukleósíðbakritahemill (NRTI)
English: How to take Delstrigo
Icelandic: Hvernig nota á Delstrigo
English: Ribavirin (50 microM) used in the treatment of chronic HCV infection decreased the anti-HIV-1 activity of lamivudine by 3.5-fold in MT-4 cells.
Icelandic: 3,5 falt úr and-HIV-1 virkni lamivudins í MT-4 frumum.
English: Missed dose
Icelandic: Skert frjósemi
English: Tabulated summary of adverse reactions
Icelandic: Samhliða meðferð annarra veirulyfja
English: Renal and urinary disorders Uncommon increased creatinine*, proximal renal tubulopathy (including Fanconi syndrome)*
Icelandic: Sjaldgæfar aukið kreatínín*, aðlægur píplukvilli í nýrum (þ.m.t. Fanconi heilkenni)*
English: Table 2: Tabulated summary of adverse reactions associated with doravirine/lamivudine/tenofovir disoproxil
Icelandic: Tafla með aukaverkunum sem tengjast doravirini/lamivudin/tenofovir disoproxili Tíðni
English: Patients who are co-infected with HIV-1 and HBV should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment with Delstrigo.
Icelandic: Fylgjast á náið með sjúklingum sem eru samhliða sýktir með HIV-1 og HBV bæði klínískt og með rannsóknaniðurstöðum a.m.k.
English: Animal studies with doravirine do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Icelandic: Dýrarannsóknir benda hvorki til beinna né óbeinna skaðlegra áhrifa doravirin á æxlun (sjá kafla 5.3).
English:  doravirine AUC 0.83 (0.76, 0.91) Cmax 0.88 (0.76, 1.01) C24 0.84 (0.77, 0.92)
Icelandic: AUC 0,83 (0,76; 0,91) Cmax 0,88 (0,76; 1,01) C24 0,84 (0,77; 0,92)
English: Infections and infestations Rare rash pustular
Icelandic: Sýkingar af völdum sýkla og sníkjudýra Mjög sjaldgæfar graftarútbrot
English: General disorders and administration site conditions Common fatigue, fever*
Icelandic: Almennar aukaverkanir og aukaverkanir á íkomustað Algengar þreyta, hiti*
English: Proportion (%) of Subjects With HIV-1 RNA < 40 copies/mL by Baseline Regimen Received
Icelandic: 24 metið með tilliti til hlutfalls þátttakenda með HIV-1 RNA < 40 eintök/ml.
English: Recommendation Concerning Co-administration with doravirine/lamivudine/tenofo vir disoproxil ledipasvir + sofosbuvir (90 mg ledipasvir SD + 400 mg sofosbuvir SD, doravirine 100 mg SD)
Icelandic: ledipasvir + sofosbuvir (90 mg ledipasvir SD + 400 mg sofosbuvir SD, doravirin 100 mg SD)
English: Effects on Medicinal Product Levels
Icelandic: Upplýsingar fyrir notanda lyfsins
English: daclatasvir
Icelandic: dasabuvir
English: omeprazole
Icelandic: Aukaverkanir
English: indigestion, soft stools, stomach spasms, frequent bowel movements, inflammation of the pancreas (pancreatitis) (causing stomach pain, vomiting)
Icelandic: • hægðatregða, magaóþægindi, þrútinn eða þaninn kviður (uppþemba), meltingartruflanir, linar hægðir, magakrampi, tíðar þarmahreyfingar, brisbólga (veldur kviðverkjum, uppköstum)