FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor if you take: - dolutegravir, maraviroc, amprevanir/ritonavir and fosamprenavir/ritonavir (anti-HIV medicine) - amiodarone, bepridil, digoxin, disopyramide, flecainide, lidocaine, mexiletine, propafenone and quinidine (medicines to treat certain heart disorders, e.g., abnormal heart beat) - warfarin (a medicine used to reduce clotting of the blood).
Icelandic: Segðu lækninum frá því ef þú tekur: - dolutegravir, maraviroc, amprenavir/ritonavir og fosamprenavir/ritonavir (lyf við HIV) - amiodaron, bepridil, digoxín, disopyramid, flecainid, lidocain, mexiletin, propafenon og kínidín
English: This combination can be used without dose adjustment.
Icelandic: Þessa samsetningu má nota án skammtaaðlögunar.
English: Frequency category
Icelandic: Tíðniflokkun Aukaverkun
English: Tablet White to off-white, oval tablet debossed with “T125” on one side and “100” on the other side.
Icelandic: Hvít eða beinhvít sporöskjulaga tafla, með ígreyptu „T125“ á annarri hliðinni og „100“ á hinni.
English: INTELENCE and azithromycin can be used without dose adjustments.
Icelandic: INTELENCE og azitromycin má nota án aðlögunar skammta.
English: Rash was mostly self-limiting and generally resolved within 1 to 2 weeks on continued therapy.
Icelandic: Útbrotin gengu oftast til baka af sjálfu sér og voru yfirleitt horfin innan 1-2 vikna við áframhaldandi meðferð.
English: < 400 HIV-1 RNA copies/ml n (%)
Icelandic: RNA eintök/ml n (%)
English: 40 mg once daily etravirine
Icelandic: 40 mg einu sinni á sólarhring etravirin
English: INTELENCE and digoxin can be used without dose adjustments.
Icelandic: INTELENCE og digoxín má nota án aðlögunar skammta.
English: Exposure in mice was equivalent to human exposure while in rats it was below the clinical exposure at the recommended dose.
Icelandic: Útsetning hjá músum var samsvarandi og hjá mönnum en hjá rottum var útsetning minni en klínísk útsetning hjá mönnum við ráðlagða skammta.
English: The DRESS syndrome is characterised by rash, fever, eosinophilia and systemic involvement (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis and eosinophilia).
Icelandic: Einkenni DRESS-heilkennis eru útbrot, hiti, eósínfíklafjöld og almenn einkenni (þ.m.t., en ekki einskorðað við, alvarleg útbrot eða útbrot með hita, almennur lasleiki, þreyta, vöðva- eða liðverkir, blöðrur, sár í munni, tárubólga, lifrarbólga og eósínfíklafjöld).
English: Concomitant use of etravirine with efavirenz or nevirapine may cause a significant decrease in the plasma concentration of etravirine and loss of therapeutic effect of etravirine.
Icelandic: Samhliða notkun etravirins og efavirenz eða nevirapins getur valdið marktækri lækkun á plasmaþéttni etravirins og dregið úr verkun etravirins.
English: A plastic bottle containing 60 tablets and 3 pouches to keep the tablets dry.
Icelandic: Plastglas sem inniheldur 60 töflur og 3 poka sem halda töflunum þurrum.
English: Severe cutaneous and hypersensitivity reactions
Icelandic: Alvarleg viðbrögð og ofnæmi í húð
English: INTELENCE is expected to decrease plasma concentrations of these antiarrhythmics.
Icelandic: Gert er ráð fyrir að INTELENCE lækki plasmaþéttni þessara hjartsláttaróreglulyfja.
English: It is not recommended to co-administer INTELENCE with other NNRTIs.
Icelandic: Ekki er mælt með samhliða notkun INTELENCE og annarra NNRTI-lyfja.
English: No significant pharmacokinetic differences have been observed between males and females.
Icelandic: Enginn marktækur munur hefur sést á lyfjahvörfum milli kynja.
English: Adverse reactions reported in patients treated with etravirine are summarised in Table 2.
Icelandic: Aukaverkanir sem greint var frá hjá sjúklingum í meðferð með etravirini eru teknar saman í töflu
English: Each tablet contains 40 mg lactose (as monohydrate).
Icelandic: Hver tafla inniheldur 40 mg af laktósa (sem einhýdrat).
English: Rash was most frequently mild to moderate, generally macular to maculopapular or erythematous, mostly occurred in the second week of therapy, and was infrequent after week 4.
Icelandic: Algengast var að útbrot væru væg eða miðlungsmikil, yfirleitt dröfnuútbrot, dröfnuörðuútbrot eða roðaþotsútbrot sem komu yfirleitt fram í annarri viku meðferðar og voru sjaldgæf eftir 4. viku.
English: Darunavir/ritonavir 600/100 mg twice daily darunavir
Icelandic: Darunavir/ritonavir 600/100 mg tvisvar á sólarhring darunavir
English: Disopyramide Flecainide Lidocaine (systemic) Mexiletine Propafenone Quinidine
Icelandic: Lidocain (óstaðbundið) Mexiletin
English: - The other ingredients are hypromellose, microcrystalline cellulose, colloidal anhydrous silica,
Icelandic: - Önnur innihaldsefni eru hýprómellósi, örkristallaður sellulósi, vatnsfrí kísilkvoða,
English: Rifapentine
Icelandic: Rifapentin
English: Uncommon side effects (may affect up to 1 in 100 people) - decreased number of white blood cells; - symptoms of infection (for example enlarged lymph nodes and fever); - abnormal dreams, confusion, disorientation, nervousness, nightmares; - drowsiness, trembling, fainting, seizures, disturbance in attention; - dizziness, sluggishness; - angina, irregular heart rhythm; - difficulty breathing; - retching, inflammation of the pancreas, vomiting blood; - liver problems such as hepatitis, enlarged liver; - excessive sweating, swelling of the face and/or throat; - swelling of breasts in men.
Icelandic: Sjaldgæfar aukaverkanir (geta komið fyrir hjá allt að 1 af hverjum 100 einstaklingum) - fækkun hvítra blóðkorna - einkenni sýkingar (t.d. eitlastækkun og hiti) - óeðlilegir draumar, ringlun, vistarfirring, taugaóstyrkur, martraðir - syfja, skjálfti, yfirlið, flog, athyglisbrestur - sundl, sljóleiki - hjartaöng, hjartsláttaróregla - öndunarerfiðleikar - tilhneiging til að kúgast, brisbólga, blóðug uppköst - lifrarvandamál eins og lifrarbólga, lifrarstækkun - aukin svitamyndun, þroti í andliti og/eða hálsi - brjóstastækkun hjá karlmönnum.
English: INTELENCE and voriconazole can be used without dose adjustments.
Icelandic: INTELENCE og voriconazol má nota án skammtaaðlögunar.
English: In the morning, take two 100 milligram INTELENCE tablets, following a meal.
Icelandic: Að morgni tekurðu tvær 100 milligramma INTELENCE töflur, eftir máltíð.
English: Skin and subcutaneous tissue disorders very common rash common night sweats, dry skin, prurigo uncommon angioneurotic oedema a, swelling face, hyperhidrosis rare
Icelandic: Ofnæmisbjúgur a, þroti í andliti, ofursvitnun Mjög sjaldgæfar Stevens-Johnson heilkenni a, regnbogaroðasótt
English: Lactose intolerance and lactase deficiency
Icelandic: Laktósaóþol og laktasaskortur
English: Use in children and adolescents 6 years of age and older and weighing at least 16 kg The doctor will work out the right dose based on the weight of the child.
Icelandic: 16 kg Læknirinn mun ákvarða réttan skammt með tilliti til þyngdar barnsins.
English: INTELENCE and fluconazole can be used without dose adjustments.
Icelandic: INTELENCE og fluconazol má nota án skammtaaðlögunar.
English: Delay in stopping INTELENCE treatment after the onset of severe rash may result in a life-threatening reaction.
Icelandic: INTELENCE er ekki hætt um leið og alvarleg útbrot koma fram getur það leitt til lífshættulegra viðbragða.
English: In the evening, take two 100 milligram INTELENCE tablets, following a meal.
Icelandic: Að kvöldi tekurðu tvær 100 milligramma INTELENCE töflur, eftir máltíð.
English: No dose adjustment is suggested in patients with mild or moderate hepatic impairment (Child-Pugh Class A or B); INTELENCE should be used with caution in patients with moderate hepatic impairment.
Icelandic: Engin skammtaaðlögun er ráðlögð hjá sjúklingum með vægt eða í meðallagi skerta lifrarstarfsemi (Child-Pugh flokkur A eða B).
English: Known and theoretical interactions with selected antiretrovirals and non-antiretroviral medicinal products are listed in table 1.
Icelandic: Þekktar og fræðilegar milliverkanir við ákveðin andretróveirulyf og lyf sem ekki eru andretróveirulyf eru taldar upp í töflu
English: Clarithromycin 500 mg twice daily clarithromycin AUC ↓ 0.61 (0.53-0.69) Cmin ↓ 0.47 (0.38-0.57) Cmax ↓ 0.66 (0.57-0.77) 14-OH-clarithromycin AUC ↑ 1.21 (1.05-1.39) Cmin ↔ 1.05 (0.90-1.22) Cmax ↑ 1.33 (1.13-1.56) etravirine
Icelandic: Klaritrómýcín 500 mg tvisvar á sólarhring klaritrómýcín AUC ↓ 0,61 (0,53-0,69) Cmin ↓ 0,47 (0,38-0,57) Cmax ↓ 0,66 (0,57-0,77) 14-OH-klaritrómýcín AUC ↑ 1,21 (1,05-1,39) Cmin ↔ 1,05 (0,90-1,22) Cmax ↑ 1,33 (1,13-1,56) etravirin
English: Each tablet contains less than 1 mmol sodium (23 mg), and is essentially sodium-free.
Icelandic: Hver tafla inniheldur minna en 1 mmól (23 mg) af natríum, þ.e.a.s. er sem næst natríumlaust.
English: Each tablet contains 160 mg lactose (as monohydrate).
Icelandic: Hver tafla inniheldur 160 mg af laktósa (sem einhýdrat).
English: Paediatric population (6 years to less than 18 years of age) The pharmacokinetics of etravirine in 101 treatment-experienced HIV-1 infected paediatric patients, 6 years to less than 18 years of age and weighing at least 16 kg, showed that the administered weight-based dosages resulted in etravirine exposure comparable to that in adults receiving etravirine 200 mg twice daily (see sections 4.2 and 5.2) when administered at a dose corresponding to 5.2 mg/kg twice daily.
Icelandic: 16 kg, sýndu að gjöf skammta sem miðast við líkamsþyngd leiddi til útsetningar fyrir etravirini sem var svipuð og hjá fullorðnum sem fengu etravirin 200 mg tvisvar sinnum á sólarhring (sjá kafla 4.2 og 5.2) þegar gefnir voru skammtar sem samsvöruðu 5,2 mg/kg tvisvar sinnum á sólarhring.
English: Study was conducted with tenofovir disoproxil fumarate 300 mg once daily Note: In drug-drug interaction studies, different formulations and/or doses of etravirine were used which led to similar exposures and, therefore, interactions relevant for one formulation are relevant for the other.
Icelandic: Í rannsóknum á lyfjamilliverkunum voru notuð mismunandi lyfjaform og/eða mismunandi skammtar af etravirini, sem höfðu í för með sér svipaða útsetningu, þannig að milliverkanir eiga við um bæði lyfjaformin.
English: Always take the tablet(s) following a meal.
Icelandic: Taktu töflurnar alltaf eftir máltíð.
English: amnesia, somnolence uncommon convulsion, syncope, tremor, hypersomnia, disturbance in attention
Icelandic: Krampar, yfirlið, skjálfti, ofursvefn (hypersomnia), athyglisbrestur
English: It is not recommended to combine INTELENCE with any of the following medicines: - tipranavir/ritonavir, efavirenz, nevirapine, rilpivirine, indinavir, nelfinavir, atazanavir/cobicistat,
Icelandic: INTELENCE samhliða eftirfarandi lyfjum: - tipranaviri/ritonaviri, efavirenzi, nevirapini, rilpivirini, indinaviri, nelfinaviri,
English: Etravirine is primarily metabolised and eliminated by the liver.
Icelandic: Etravirin umbrotnar og útskilst fyrst og fremst í lifur.
English: Dexamethasone is expected to decrease plasma concentrations of etravirine
Icelandic: Gert er ráð fyrir að dexametason lækki plasmaþéttni etravirins.
English: Medicinal products that induce CYP3A4, CYP2C9 or CYP2C19 may increase the clearance of etravirine, resulting in lowered plasma concentrations of etravirine.
Icelandic: Lyf sem hvetja CYP3A4, CYP2C9 eða CYP2C19 geta aukið úthreinsun etravirins, en það leiðir til lægri plasmaþéttni etravirins.
English: Common side effects (may affect up to 1 in 10 people) - allergic reactions (hypersensitivity); - diabetes, decrease of appetite; - anxiety, sleepiness, sleeplessness, sleep disorders; - tingling or pain in hands or feet, numbness, loss of skin sensibility, loss of memory tiredness; - blurred vision; - kidney failure, high blood pressure, heart attack, shortness of breath when exercising; - vomiting, heartburn, abdominal pain, distension of the abdomen, inflammation of the stomach,
Icelandic: Algengar aukaverkanir (geta komið fyrir hjá allt að 1 af hverjum 10 einstaklingum) - ofnæmisviðbrögð - sykursýki, minnkuð matarlyst - kvíði, syfja, svefnleysi, svefnraskanir - stingir eða verkir í höndum eða fótum, dofi, minnkað húðskyn, minnisleysi, þreyta - þokusýn - nýrnabilun, hár blóðþrýstingur, hjartaáfall, mæði við áreynslu - uppköst, brjóstsviði, kviðverkir, þaninn kviður, magabólga, vindgangur, hægðatregða,
English: INTELENCE and these antifungals can be used without dose adjustments.
Icelandic: INTELENCE og þessi lyf gegn sveppasýkingum má nota án skammtaaðlögunar.
English: Rifampicin and rifapentine are expected to decrease plasma concentrations of etravirine.
Icelandic: Gert er ráð fyrir að rifampicin og rifapentin lækki plasmaþéttni etravirins.
English: Co-administration of Intelence and daclatasvir is not recommended.
Icelandic: Samhliða gjöf INTELENCE og daclatasvirs er ekki ráðlögð.
English: INTELENCE should only be used with dolutegravir when co-administered with atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir.
Icelandic: INTELENCE á eingöngu að nota samhliða dolutegravir með samhliða gjöf atazanavir/ritonavir, darunavir/ritonavir eða lopinavir/ritonavir.
English: All ranges * Etravirine RAMs = V90I, A98G, L100I, K101E/P, V106I, V179D/F, Y181C/I/V, G190A/S
Icelandic: V90I, A98G, L100I, K101E/P, V106I, V179D/F, Y181C/I/V og G190A/S (sjá kafla 5.1).
English: INTELENCE 25 mg tablets
Icelandic: INTELENCE 25 mg töflur
English: Sensitivity of the virus to etravirine at screening was required.
Icelandic: Næmi veirunnar fyrir etravirini við skimun var krafa.
English: No dose adjustment for INTELENCE is necessary.
Icelandic: Aðlögun á INTELENCE skammtinum er ekki nauðsynleg.
English: Etravirine is expected to increase plasma concentrations of diazepam.
Icelandic: Gert er ráð fyrir að etravirin hækki plasmaþéttni diazepams.
English: Etravirine + BR N = 599
Icelandic: Etravirin + BR N
English: AUC ↑ 1.10 (0.94-1.28) Cmax ↑ 1.10 (0.94-1.29) Cmin ↓ 0.88 (0.66-1.17) etravirine
Icelandic: AUC ↑ 1,10 (0,94-1,28) Cmax ↑ 1,10 (0,94-1,29) Cmin ↓ 0,88 (0,66-1,17) etravirin
English: 400/100 mg twice daily lopinavir
Icelandic: 400/100 mg tvisvar á sólarhring lopinavir
English: INTELENCE tablets contain lactose.
Icelandic: INTELENCE töflur innihalda mjólkursykur (laktósa).
English: A plastic bottle containing 120 tablets and 2 pouches to keep the tablets dry.
Icelandic: Plastglas sem inniheldur 120 töflur og 2 poka sem halda töflunum þurrum.
English: INTELENCE and tenofovir can be used without dose adjustments.
Icelandic: INTELENCE og tenofovir má nota án aðlögunar á skömmtum.
English: The effects of INTELENCE or other medicines might be influenced if you take INTELENCE together with any of the following medicines.
Icelandic: Ef þú tekur INTELENCE samhliða einhverjum af eftirfarandi lyfjum getur það haft áhrif á verkun INTELENCE eða annarra lyfja.
English: INTELENCE and raltegravir can be used without dose adjustments.
Icelandic: INTELENCE og raltegravir má nota án aðlögunar skammta.
English: The bottle is a high-density polyethylene (HDPE) plastic bottle containing 120 tablets and 2 desiccant pouches, fitted with a polypropylene (PP) child resistant closure.
Icelandic: Glasið er háþéttnipólýetýlen (HDPE) plastglas sem inniheldur 120 töflur og 2 rakadræga poka með pólýprópýlen (PP) barnaöryggisloki.
English: Etravirine is excreted in human milk.
Icelandic: Etravirin skilst út í brjóstamjólk.
English: Rash has been reported with etravirine.
Icelandic: Greint hefur verið frá útbrotum af völdum etravirins.
English: Since etravirine is highly protein bound, dialysis is unlikely to result in significant removal of the active substance.
Icelandic: Þar sem etravirin er að mestu leyti próteinbundið er ólíklegt að hægt sé að fjarlægja virkt lyf með blóðskilun.
English: Etravirine significantly reduced plasma concentrations of dolutegravir.
Icelandic: Etravirin veldur marktækri lækkun á plasmaþéttni dolutegravirs.
English: Each tablet contains 160 mg of lactose monohydrate.
Icelandic: Hver tafla inniheldur 160 mg af laktósaeinhýdrati.
English: The recommended dose of INTELENCE is one tablet twice a day.
Icelandic: Ráðlagður skammtur af INTELENCE er ein tafla tvisvar á sólarhring.
English: There is no specific antidote for overdose with etravirine.
Icelandic: Ekkert sérstakt mótefni er til við ofskömmtun etravirins.
English: dolutegravir AUC↔ 1.11(1.02-1.20) Cmin ↑ 1.28 (1.13-1.45) Cmax ↔ 1.07 (1.02-1.13) etravirine
Icelandic: dolutegravir AUC↔ 1,11(1,02-1,20) Cmin ↑ 1,28 (1,13-1,45) Cmax ↔ 1,07 (1,02-1,13) etravirin
English: Other NRTIs
Icelandic: Önnur NRTI-lyf
English: The bottle is a high-density polyethylene (HDPE) plastic bottle containing 60 tablets and 3 desiccant pouches, fitted with a polypropylene (PP) child resistant closure.
Icelandic: Glasið er háþéttnipólýetýlen (HDPE) plastglas sem inniheldur 60 töflur og 3 rakadræga poka með pólýprópýlen (PP) barnaöryggisloki.
English: INTELENCE and saquinavir/ritonavir can be used without dose adjustments.
Icelandic: INTELENCE og saquinavir/ritonavir má nota án aðlögunar skammta.
English: INTELENCE 25 mg tablets etravirine
Icelandic: INTELENCE 25 mg töflur etravirin
English: No interaction is expected for either INTELENCE or enfuvirtide when co-administered.
Icelandic: INTELENCE né enfuvirtids þegar lyfin eru gefin saman.
English: ≥ 16 to < 20 kg
Icelandic: ≥ 16 til < 20 kg 100 mg tvisvar á sólarhring
English: AUC ↑ 1.69 (1.53-1.86) Cmin ↑ 1.77 (1.39-2.25) Cmax ↑ 1.62 (1.47-1.79) etravirine
Icelandic: AUC ↑ 1,69 (1,53-1,86) Cmin ↑ 1,77 (1,39-2,25) Cmax ↑ 1,62 (1,47-1,79) etravirin
English: A plastic bottle containing 120 tablets and 3 pouches to keep the tablets dry.
Icelandic: Plastglas sem inniheldur 120 töflur og 3 poka sem halda töflunum þurrum.
English: Do not use after 6 weeks of first opening the bottle.
Icelandic: Notið innan 6 vikna frá því glasið var fyrst opnað.
English: The combination of oestrogen- and/or progesterone-based contraceptives and INTELENCE can be used without dose adjustment.
Icelandic: Estrógen- og/eða prógesterón-getnaðarvarnarlyf má nota samhliða INTELENCE án skammtaaðlögunar.
English: Each tablet of INTELENCE contains 25 mg of etravirine.
Icelandic: Hver tafla af INTELENCE inniheldur 25 mg af etravirini.
English: Co-administration of etravirine and medicinal products that inhibit CYP3A4, CYP2C9 or CYP2C19 may decrease the clearance of etravirine and may result in increased plasma concentrations of etravirine.
Icelandic: Samtímis gjöf etravirins og lyfja sem hamla CYP3A4, CYP2C9 eða CYP2C19 getur minnkað úthreinsun etravirins og leitt til aukinnar plasmaþéttni etravirins.
English: The observed hepatocellular findings in female mice are generally considered to be rodent specific, associated with liver enzyme induction, and of limited relevance to humans.
Icelandic: Lifrarfrumuniðurstöðurnar, sem komu fram hjá kvenkyns músum, eru taldar tengjast hvötun lifrarensíma og almennt taldar sértækar fyrir nagdýr.
English: Do not use after 8 weeks of first opening the bottle.
Icelandic: Notið innan 8 vikna frá því glasið var fyrst opnað.
English: Each tablet contains 40 mg of lactose monohydrate.
Icelandic: Hver tafla inniheldur 40 mg af laktósaeinhýdrati.
English: In HIV infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Icelandic: Ónæmisendurvirkjunarheilkenni (Immune Reconstitution Syndrome) Hjá HIV-sýktum sjúklingum með alvarlegan ónæmisbrest við upphaf samsettrar andretróveirumeðferðar getur komið fram bólgusvörun við einkennalausum tækifærissýklum eða leifum þeirra.
English: INTELENCE 200 mg tablets
Icelandic: INTELENCE 200 mg töflur
English: INTELENCE 100 mg tablets
Icelandic: INTELENCE 100 mg töflur
English: AUC ↔ 0.87 (0.83-0.92) Cmin ↓ 0.80 (0.73-0.88) Cmax ↔ 0.89 (0.82-0.96) etravirine
Icelandic: AUC ↔ 0,87 (0,83-0,92) Cmin ↓ 0,80 (0,73-0,88) Cmax ↔ 0,89 (0,82-0,96) etravirin
English: AUC ↑ 1.18 (1.03-1.36) Cmin ↑ 1.24 (0.96-1.59) Cmax ↑ 1.14 (1.02-1.27) etravirine
Icelandic: AUC ↑ 1,18 (1,03-1,36) Cmin ↑ 1,24 (0,96-1,59) Cmax ↑ 1,14 (1,02-1,27) etravirin
English: An increase in the incidences of hepatocellular adenomas and carcinomas were observed in female mice.
Icelandic: Aukin tíðni lifrarfrumukirtilæxla og -krabbameina kom fram hjá kvenkyns músum.
English: The bottle is a high-density polyethylene (HDPE) plastic bottle containing 120 tablets and 3 desiccant pouches, fitted with a polypropylene (PP) child resistant closure.
Icelandic: Glasið er háþéttnipólýetýlen (HDPE) plastglas sem inniheldur 120 töflur og 3 rakadræga poka með pólýprópýlen (PP) barnaöryggisloki.
English: Baseline genotype or phenotype and virologic outcome analyses In DUET-1 and DUET-2, the presence at baseline of 3 or more of the following mutations: V90I, A98G, L100I, K101E, K101P, V106I, V179D, V179F, Y181C, Y181I, Y181V, G190A and G190S, (etravirine RAMs) was associated with a decreased virologic response to etravirine (see table 5).
Icelandic: V90I, A98G, L100I, K101E, K101P, V106I, V179D, V179F, Y181C, Y181I, Y181V, G190A og G190S, (etravirin ónæmistengdar stökkbreytingar (RAM)) (sjá töflu 5).
English: AUC ↔ 1.15 (1.05-1.26) Cmin ↔ 1.02 (0.90-1.17) Cmax ↔ 1.11 (1.01-1.22) etravirine
Icelandic: AUC ↔ 1,15 (1,05-1,26) Cmin ↔ 1,02 (0,90-1,17) Cmax ↔ 1,11 (1,01-1,22) etravirin
English: The European Medicines Agency has deferred the obligation to submit the results of studies with INTELENCE in one or more subsets of the paediatric population in human immunodeficiency virus infection, as per Paediatric Investigation Plan (PIP) decision in the granted indication (see section 4.2 for information on paediatric use).
Icelandic: „Paediatric Investigation Plan (PIP)“, fyrir samþykkta ábendingu (sjá upplýsingar í kafla 4.2 um notkun handa börnum).
English: Hepatitis B and/or hepatitis C virus co-infection
Icelandic: B og/eða lifrarbólgu
English: If a patient misses a dose by more than 6 hours of the time it is usually taken, the patient should not take the missed dose and simply resume the usual dosing schedule.
Icelandic: hafa liðið frá því að taka átti skammtinn, skal sjúklingurinn sleppa skammtinum sem gleymdist og halda áfram að taka lyfið samkvæmt áætlun.
English: In the morning, take one 200 milligram INTELENCE tablet, following a meal.
Icelandic: Að morgni tekurðu eina 200 milligramma INTELENCE töflu, eftir máltíð.
English: Hypromellose Microcrystalline cellulose Colloidal anhydrous silica Croscarmellose sodium Magnesium stearate Lactose monohydrate
Icelandic: Hýprómellósi Örkristallaður sellulósi Vatnsfrí kísilkvoða Natríumkroskarmellósi
English: INTELENCE and didanosine can be used without dose adjustments.
Icelandic: INTELENCE og didanosin má nota án aðlögunar á skömmtum.
English: INTELENCE 200 mg tablets etravirine
Icelandic: INTELENCE 200 mg töflur etravirin
English: How to store INTELENCE Contents of the pack and other information
Icelandic: INTELENCE Pakkningar og aðrar upplýsingar
English: Based on these trial results, etravirine is not recommended for use in combination with N(t)RTIs only in patients who have experienced virological failure on an NNRTI- and N(t)RTI-containing regimen.
Icelandic: Með tilliti til þessara niðurstaðna er ekki mælt með notkun etravirins í samsettri meðferð með N(t)
English: Pivotal studies
Icelandic: stigs rannsóknunum
English: AUC ↓ 0.83 (0.75-0.94) Cmin ↓ 0.76 (0.66-0.87) Cmax ↓ 0.90 (0.78-1.03) 25-O-desacetyl-rifabutin AUC ↓ 0.83 (0.74-0.92) Cmin ↓ 0.78 (0.70-0.87) Cmax ↓ 0.85 (0.72-1.00) etravirine
Icelandic: AUC ↓ 0,83 (0,75-0,94) Cmin ↓ 0,76 (0,66-0,87) Cmax ↓ 0,90 (0,78-1,03) 25-O-desacetýl-rifabutin AUC ↓ 0,83 (0,74-0,92) Cmin ↓ 0,78 (0,70-0,87) Cmax ↓ 0,85 (0,72-1,00) etravirin
English: AUC ↔ 0.94 (0.88-1.01) Cmin ↔ 0.91 (0.84-0.98) Cmax ↔ 0.92 (0.85-1.00) etravirine
Icelandic: AUC ↔ 0,94 (0,88-1,01) Cmin ↔ 0,91 (0,84-0,98) Cmax ↔ 0,92 (0,85-1,00) etravirin
English: Dolutegravir + Lopinavir/ritonavir 50 mg once daily + 400/100 mg twice daily dolutegravir AUC ↓ 0.29 (0.26-0.34) Cmin ↓ 0.12 (0.09-0.16) Cmax ↓ 0.48 (0.43-0.54) etravirine
Icelandic: + 400/100 mg tvisvar á sólarhring dolutegravir AUC ↓ 0,29 (0,26-0,34) Cmin ↓ 0,12 (0,09-0,16) Cmax ↓ 0,48 (0,43-0,54) etravirin
English: Pooled DUET Studies ≥ 18 years ETR N = 599
Icelandic: ≥ 18 ára ETR N