FrancophonIA/ELRC3.0 huggingface dataset:
English: Don't stop unless your doctor advises you to.
Icelandic: Ekki hætta nema samkvæmt læknisráði.
English: In the presence of integrase class resistance alternative combinations that do not include nevirapine should be considered (see section 4.4).
Icelandic: Ef um er að ræða ónæmi fyrir integrasaflokknum skal íhuga aðrar samsetningar án nevírapíns (sjá kafla 4.4).
English: • hyperactivity (excessive restlessness and movement)
Icelandic: • ofvirkni (mikið eirðarleysi eða hreyfiþörf)
English: Antacids, to treat indigestion and heartburn, can stop Tivicay being absorbed into your body and make it less effective.
Icelandic: Sýrubindandi lyf gegn meltingartruflunum og brjóstsviða geta hindrað frásog Tivicay í líkamanum og dregið úr virkni þess.
English: Q148 +≥2 secondary mutations 3
Icelandic: Q148+2 afleiddar stökkbreytingar b
English: Dolutegravir is primarily metabolized through glucuronidation via UGT1A1 with a minor CYP3A component.
Icelandic: Umbrot dolutegravírs eru aðallega með samtengingu við glúkúróníð fyrir tilstilli UGT1A1 og að litlu leyti CYP3A.
English: Clinical status including liver aminotransferases and bilirubin should be monitored.
Icelandic: Hafa skal eftirlit með klínísku ástandi þ.m.t. lifraramínótransferösum og bilírúbúni.
English: Tivicay tablets on a weight-band basis (20 mg, 25 mg, 35 mg, 50 mg) in children of at least 6 years of age weighing at least 15 kg provides comparable exposure to that observed in adults (50 mg), with the lowest weight band of 15 to <20 kg corresponding to 20 mg daily.
Icelandic: 15 kg er sambærileg útsetningu hjá fullorðnum (50 mg) við minnsta þyngdarbil sem er 15 til <20 kg sem samsvarar 20 mg daglega.
English: Dolutegravir ↔ AUC ↑ 33% Cmax ↑ 29% Cτ ↑ 45% Daclatasvir ↔
Icelandic: Dolutegravír  AUC  33% Cmax  29% C  45% Daclatasvír 
English: Warnings and precautions Look out for important symptoms
Icelandic: Fylgist með mikilvægum einkennum
English: INFORMATION IN BRAILLE tivicay 10 mg
Icelandic: tivicay 10 mg
English: Alternative combinations that do not include these metabolic inducers should be used where possible in INIresistant patients.
Icelandic: Nota skal aðrar samsetningar, sem ekki innihalda þessa ensímörva, þegar hægt er hjá INI-ónæmum sjúklingum.
English: Virologic non-response HIV-1 RNA <50 copies/mL by baseline covariates Baseline Viral Load (copies/mL) ≤50,000 copies/mL >50,000 copies/mL Baseline CD4+ (cells/ mm3)
Icelandic: RNA <50 eintök/ml samkvæmt stýribreytum (covariates) í upphafi Veirufjöldi í upphafi (eintök/ml) 50.000 eintök/ml >50.000 eintök/ml CD4+ í upphafi (frumur/ mm
English: At baseline, median patient age was 34 years, 15% were female, 28% non-white, 10% had hepatitis B and/or C co-infection, and 3% were CDC Class C; these characteristics were similar between treatment groups.
Icelandic: Í upphafi var miðgildi aldurs sjúklinga 34 ár, 15% voru konur, 28% voru ekki hvítir, 10% voru einnig sýktir af lifrarbólgu B og/eða C og 3% voru í CDC flokki C. Þessi sérkenni voru svipuð í meðferðarhópunum.
English: Because gastrointestinal (GI) intolerance is considered to be due to local active substance administration, mg/kg or mg/m2 metrics are appropriate determinates of safety cover for this toxicity.
Icelandic: Vegna óþols í meltingarvegi sem talið er vera vegna staðbundinnar gjafar virks efnis eru mælikvarðarnir mg/kg eða mg/m viðeigandi til að meta öryggismörk fyrir þessar eiturverkanir.
English: • phenytoin and phenobarbital, to treat epilepsy
Icelandic: • fenýtóín og fenóbarbital, gegn flogaveiki
English: Population pharmacokinetic analysis of dolutegravir using data in HIV-1 infected adults showed that there was no clinically relevant effect of age on dolutegravir exposure.
Icelandic: Samkvæmt þýðisgreining á lyfjahvörfum dolutegravírs með notkun gagna frá HIV-1-smituðum fullorðnum hafði aldur engin áhrif af klínískri þýðingu á útsetningu fyrir dolutegravíri.
English: The bottle contains a desiccant to reduce moisture.
Icelandic: Glasið inniheldur þurrkhylki til að draga úr raka.
English: The linearity of dolutegravir pharmacokinetics is dependent on dose and formulation.
Icelandic: Línulegt samband lyfjahvarfa dolutegravírs er háð skammti og lyfjaformi.
English: Skin and subcutaneous tissue disorders
Icelandic: Húð og undirhúð Algengar
English: Non-B
Icelandic: Ekki-B (Non-B)
English: At baseline, median patient age was 43 years, 32% were female, 50% non-white, 16% had hepatitis B and/or C co-infection, and 46% were CDC Class C. All patients had at least two class ART resistance, and 49% of subjects had at least 3-class ART resistance at baseline.
Icelandic: Í upphafi var miðgildi aldurs sjúklinga 43 ár, 32% voru konur, 50% voru ekki af hvíta kynþættinum, 16% voru einnig með lifrarbólgu B og/eða C og 46% voru í CDC-flokki C. Allir sjúklingar höfðu ónæmi fyrir a.m.k. tveimur flokkum retróveirulyfja og 49% einstaklinga höfðu ónæmi fyrir a.m.k.
English: No dosage adjustment is considered necessary for patients with renal impairment.
Icelandic: Ekki er talin þörf á skammtaaðlögun hjá sjúklingum með skerta nýrnastarfsemi.
English: *particularly in patients with a pre-existing history of depression or psychiatric illness.
Icelandic: Sjálfsvígshugsanir*, sjálfsvígstilraunir* *einkum hjá sjúklingum með sögu um þunglyndi eða geðsjúkdóm.
English: Do not take a calcium supplement, iron supplement or multivitamin during the 6 hours before you take Tivicay, or for at least 2 hours after you take it.
Icelandic: Ekki taka sýrubindandi lyf 6 klst. áður en þú tekur Tivicay eða fyrr en a.m.k. 2 klst. eftir að þú tekur það.
English: In a juvenile toxicity study in rats, dolutegravir administration resulted in two preweanling deaths at 75 mg/kg/day.
Icelandic: Í rannsókn á eiturverkunum hjá ungum rottum sem voru enn á spena og fengu dolutegravír 75 mg/kg/dag urðu tvö dauðsföll.
English: • feeling sick (nausea).
Icelandic: • óþægindi í maga (kvið)
English: The pharmacokinetics was evaluated in 11 children 6 to 12 years of age and showed that 25 mg once daily in patients weighing at least 20 kg and 35 mg once daily in patients weighing at least 30 kg resulted in dolutegravir exposure comparable to adults.
Icelandic: Lyfjahvörf voru metin hjá 11 börnum 6 til 12 ára og sýndu að við gjöf 25 mg einu sinni á dag hjá sjúklingum sem vega a.m.k.
English: Q148+1 secondary mutationb
Icelandic: Q148 + 1 afleidd stökkbreyting
English: Particular diligence should be applied in initiating or maintaining effective hepatitis B therapy (referring to treatment guidelines) when starting dolutegravir-based therapy in hepatitis B co-infected patients (see section 4.8).
Icelandic: Mælt er með eftirliti lifrarprófa hjá sjúklingum sem einnig eru sýktir af lifrarbólgu B og/eða C. Sérstakrar nákvæmni skal gæta við upphaf eða viðhald virkrar meðferðar gegn lifrarbólgu B (með hliðsjón af leiðbeiningum um meðferð) þegar meðferð sem dolutegravír er hluti af, er hafin hjá sjúklingum sem einnig eru sýktir af lifrarbólgu B (sjá kafla 4.8).
English: Nucleoside Reverse Transcriptase Inhibitors Tenofovir
Icelandic: Núkleósíðbakritahemlar Tenofóvír
English: When co-administered with dolutegravir 50mg twice daily:
Icelandic: Við gjöf samtímis dolutegravíri 50 mg tvisvar á dag:
English: The specific dosage recommendation for the 10 mg tablet, as specified in Table 1, should be followed.
Icelandic: Fylgja skal ráðleggingum um skammta fyrir 10 mg töfluna eins og tilgreint er í töflu
English: At 96 weeks, virologic suppression in the dolutegravir group (80%) was superior to the DRV/r group (68%), (adjusted treatment difference [DTG-(DRV+RTV)]: 12.4%; 95% CI: [4.7, 20.2].
Icelandic: Eftir 96 vikur var veirufræðileg bæling hjá dolutegravír hópnum (80%) meiri en hjá DRV/r hópnum (68%), (aðlagaður meðferðarmunur [DTG-(DRV+RTV)]:
English: Dolutegravir ↔ EE ↔ AUC ↑ 3% Cmax ↓ 1%
Icelandic: Dolutegravír  EE  AUC  3% Cmax  1%
English: Delay in stopping treatment with dolutegravir or other suspect active substances after the onset of hypersensitivity may result in a life-threatening allergic reaction.
Icelandic: Ef meðferð með dolutegravíri eða öðrum virkum efnum, sem grunur er um að tengist ofnæmisviðbrögðunum, er ekki hætt strax geta ofnæmisviðbrögðin orðið lífshættuleg.
English: Subjects were enrolled with a screening plasma HIV-1 RNA of 1000
Icelandic: Þátttakendur voru teknir í rannsóknina með skimun fyrir HIV-1
English: It is unknown whether dolutegravir is excreted in human milk.
Icelandic: Ekki er vitað hvort dolutegravír skilst út í brjóstamjólk.
English: Acute hepatic failure
Icelandic: Mjög algengar Höfuðverkur
English: Dolutegravir ↔ AUC ↑ 7% Cmax ↑ 5% Cτ ↑ 8% Boceprevir ↔ (historical controls)
Icelandic: Dolutegravír  AUC  7% Cmax  5% Cτ  8% Boceprevír  (eldri samanburður)
English: In the presence of integrase class-resistance (VIKING-3 study) the following mutations were selected in 32 patients with protocol defined virological failure (PDVF) through Week 24 and with paired genotypes (all treated with dolutegravir 50 mg twice daily + optimized background agents): L74L/M (n=1), E92Q (n=2), T97A (n=9), E138K/A/T (n=8), G140S (n=2), Y143H (n=1), S147G (n=1), Q148H/K/R (n=4), and N155H (n=1) and E157E/Q (n=1).
Icelandic: L74L/M (n=1), E92Q (n=2), T97A (n=9), E138K/A/T (n=8), G140S (n=2), Y143H (n=1), S147G (n=1), Q148H/K/R (n=4) og N155H (n=1) og E157E/Q (n=1).
English: Effect of human serum
Icelandic: Áhrif mannasermis
English: Primary mutation other than
Icelandic: Frumkomin stökkbreyting
English: Oral administration of dolutegravir to pregnant rats at doses up to 1000 mg/kg daily from days 6 to 17 of gestation did not elicit maternal toxicity, developmental toxicity or teratogenicity (27 times the 50 mg twice daily human clinical exposure based on AUC).
Icelandic: Gjöf dolutegravírs til inntöku hjá rottum með fangi, í skömmtum allt að 1.000 mg/kg á dag frá degi 6 til 17 á meðgöngu, hafði ekki eiturverkanir á meðgöngu, eiturverkanir á þroska eða vansköpunarvaldandi áhrif (27 til 50 sinnum útsetning við 50 mg skammta tvisvar á dag hjá mönnum miðað við AUC).
English: Calcium supplements Dolutegravir ↓ AUC ↓ 39% Cmax ↓ 37% C24 ↓ 39% (Complex binding to polyvalent ions)
Icelandic: Dolutegravír  AUC  39% Cmax  37% C24  39% (Mynda komplexa með fjölgildum jónum)
English: Tivicay 25 mg and 50 mg film-coated tablets
Icelandic: Tivicay 25 mg og 50 mg filmuhúðaðar töflur
English: Darunavir/ritonavir + etravirine
Icelandic: Darúnavír/rítónavír + etravírín
English: Median Percent Change from Baseline
Icelandic: Miðhlutfallabreyting (%)
English: Binding of dolutegravir to plasma proteins is independent of dolutegravir concentration.
Icelandic: Próteinbinding dolutegravírs í plasma er óháð þéttni dolutegravírs.
English: In lactating rats that received a single oral dose of 50 mg/kg at 10 days postpartum, dolutegravir was detected in milk at concentrations typically higher than blood.
Icelandic: 10 dögum eftir fæðingu greindist dolutegravír í mjólk, þéttnin var yfirleitt hærri en í blóði.
English: The absolute bioavailability of dolutegravir has not been established.
Icelandic: Heildaraðgengi dolutegravírs hefur ekki verið metið.
English: At baseline, median patient age was 36 years, 14% were female, 15% non-white, 11% had hepatitis B and/or C co-infection and 2% were CDC Class C, these characteristics were similar between treatment groups.
Icelandic: Í upphafi var miðgildi aldurs sjúklinga 36 ár, 14% voru konur, 15% voru ekki af hvíta kynþættinum, 11% voru einnig með lifrarbólgu B og/eða C og 2% voru í CDC-flokki C, þessi sérkenni voru svipuð hjá báðum meðferðarhópum.
English: When co-administered with dolutegravir 50mg once daily:
Icelandic: Við gjöf samtímis dolutegravíri 50 mg einu sinni á dag:
English: § 4 subjects were excluded from the efficacy analysis due to data integrity at one study site *The Genotypic Susceptibility Score (GSS) was defined as the total number of ARTs in BR to which a subject's viral isolate showed susceptibility at baseline based upon genotypic resistance tests.
Icelandic: * Arfgerðarnæmisskor (Genotypic Susceptability Score, GSS) var skilgreint sem heildarfjöldi retróveirulyfja í bakgrunnsmeðferð sem veirustofnar einstaklingsins sýndu næmi fyrir í upphafi samkvæmt arfgerðarónæmisprófum.
English: Baseline CD4+ (cells/ mm3) 200 to <350 NRTI backbone ABC/3TC
Icelandic: CD4+ í upphafi (frumur/ mm200 til <350
English: Nelfinavir
Icelandic: Efavírenz
English: Dolutegravir was not mutagenic or clastogenic using in vitro tests in bacteria and cultured mammalian cells, and an in vivo rodent micronucleus assay.
Icelandic: Dolutegravír hafði hvorki stökkbreytandi né litningasundrandi áhrif í prófunum in vitro á bakteríum og ræktuðum spendýrafrumum og örkjarnaprófum hjá nagdýrum in vivo.
English: Antidiabetics Metformin
Icelandic: Sykursýkilyf Metformín
English: If possible, show them the Tivicay pack.
Icelandic: Sýnið þeim umbúðirnar utan af Tivicay ef unnt er.
English: Signs of osteonecrosis include:
Icelandic: Einkenni beindreps eru m.a.:
English: Dolutegravir ↓ (Not studied, decrease expected due to induction of UGT1A1 and CYP3A enzymes, a similar reduction in exposure as observed with carbamazepine is expected)
Icelandic: (Ekki rannsakað, búist við lækkun vegna örvunar UGT1A1 og CYP3A ensíma, búist við svipaðri skerðingu í útsetningu og kom fram með karbamazepíni)
English: In Phase III studies patients with hepatitis B and/or C co-infection were permitted to enrol provided that baseline liver chemistry tests did not exceed 5 times the upper limit of normal (ULN).
Icelandic: stigs rannsóknum að því tilskyldu að grunngildi lifrarprófa væru ekki yfir 5 sinnum eðlilegum efri mörkum (ULN).
English: Dolutegravir ↓ AUC ↓ 71% Cmax ↓ 52% Cτ ↓ 88%
Icelandic: Dolutegravír  AUC  71% Cmax  52% Cτ  88%
English: Oral administration of dolutegravir to pregnant rabbits at doses up to 1000 mg/kg daily from days 6 to 18 of gestation did not elicit developmental toxicity or teratogenicity (0.40 times the 50 mg twice daily human clinical exposure based on AUC).
Icelandic: Gjöf dolutegravírs til inntöku hjá kanínum með fangi, í skömmtum allt að 1000 mg/kg á dag, frá degi 6 til 18 á meðgöngu, hafði ekki eiturverkanir á þroska eða vansköpunarvaldandi áhrif (0,40 sinnum útsetning við 50 mg skammta tvisvar á dag hjá mönnum miðað við AUC).
English: INFORMATION IN BRAILLE tivicay 50 mg
Icelandic: tivicay 50 mg
English: Mean change in CD4 count from baseline at Week 48, c/ mm3 a adjusted for BL stratification factors: Plasma HIV-1 RNA (≤100,000 c/mL vs. >100,000 c/mL) and CD4+ cell count (≤200 cells/mm3 vs. >200 cells/mm3).
Icelandic: Plasma HIV-1 RNA (≤100.000 eintök/ml á móti >100.000 eintök/ml) og CD4+ frumutalning (≤200 frumur/mm3 á móti >200 frumur/mm3).
English: VO Population (HIV-1 RNA <50 c/mL, Snapshot algorithm)
Icelandic: VO-þýði (HIV-1-RNA <50 eintök/ml, örreiknirit)
English: The recommended adult dose of dolutegravir is 50 mg twice daily when co-administered with rifampicin in the absence of integrase class resistance.
Icelandic: Ráðlagður skammtur af dolutegravíri handa fullorðnum er 50 mg tvisvar á dag við gjöf samhliða rifampicíni ef ónæmi fyrir integrasaflokknum er ekki til staðar.
English: Population pharmacokinetic analysis indicated that hepatitis C virus co-infection had no clinically relevant effect on the exposure to dolutegravir.
Icelandic: Þýðisgreining á lyfjahvörfum benti til að samhliða sýking af lifrarbólguveiru C hefði engin áhrif af klínískri þýðingu á útsetningu fyrir dolutegravíri.
English: Dolutegravir ↓ AUC ↓ 57% Cmax ↓ 39% Cτ ↓ 75%
Icelandic: Dolutegravír  AUC  57% Cmax  39% Cτ  75%
English: Signs include:
Icelandic: Einkenni eru m.a.:
English: INFORMATION IN BRAILLE tivicay 25 mg
Icelandic: tivicay 25 mg
English: What you need to know before you take Tivicay 3.
Icelandic: Þú þarft að þekkja þau einkenni sem fylgjast þarf með meðan þú notar Tivicay.
English: Efavirenz ↔ (historical controls) (induction of UGT1A1 and CYP3A enzymes)
Icelandic: Efavírenz  (eldri samanburður) (örvun UGT1A1 og CYP3A ensíma)
English: Oxcarbazepine Phenytoin Phenobarbital
Icelandic: Oxkarbazepín Fenýtóín Fenóbarbital
English: If you are breast-feeding, or thinking about breast-feeding: → Talk to your doctor immediately.
Icelandic: Ef þú ert með barn á brjósti eða ert að hugsa um að hafa barn á brjósti:
English: No dosage adjustment is considered necessary for patients with mild to moderate hepatic impairment.
Icelandic: Skammtaaðlögun er ekki talin nauðsynleg hjá sjúklingum með væga til miðlungsmikla skerðingu á lifrarstarfsemi.
English: In the presence of integrase class resistance alternative combinations that do not include efavirenz should be considered (see section 4.4).
Icelandic: Ef um er að ræða ónæmi fyrir integrasaflokknum skal íhuga aðrar samsetningar án efavírenz (sjá kafla 4.4).
English: Rifabutin
Icelandic: Rifampicín
English: Rare side effects These may affect up to 1 in 1000 people:
Icelandic: Geta komið fyrir hjá allt að 1 af hverjum 1.000 einstaklingum:
English: Pharmacokinetic data for dolutegravir in subjects >65 years of age are limited.
Icelandic: Takmarkaðar upplýsingar liggja fyrir um lyfjahvörf hjá einstaklingum >65 ára.
English: Dolutegravir ↓ AUC ↓ 22% Cmax ↓ 11% C24 ↓ 38% (induction of UGT1A1 and CYP3A enzymes)
Icelandic: Dolutegravír  AUC  22% Cmax  11% C24  38% (örvun UGT1A1 og CYP3A ensíma)
English: † Includes subjects who changed BR to new class or changed BR not permitted per protocol or due to lack of efficacy prior to Week 48 (for SPRING-2 only), subjects who discontinued prior to Week 48 for lack or loss of efficacy and subjects who are ≥50 copies in the 48 week window.
Icelandic: Miðgildi breytinga á CD4 frá upphafsgildi * Aðlagað miðað við lagskiptingu í upphafi. † Þ.m.t. einstaklingar sem skiptu um bakgrunnsmeðferð yfir í nýjan flokk eða bakgrunnsmeðferð sem var ekki leyfð samkvæmt rannsóknaráætlun, vegna skorts á verkun fyrir viku 48 (aðeins fyrir SPRING-2) eða einstaklingar sem hættu þátttöku fyrir viku
English: Antacids and supplements Magnesium/ aluminium-containing antacid
Icelandic: Sýrubindandi lyf og bætiefni Sýrubindandi lyf sem innihalda magnesíum/ál
English: Bioavailability of dolutegravir depends on meal content: low, moderate, and high fat meals increased dolutegravir AUC(0-∞) by 33%, 41%, and 66%, increased Cmax by 46%, 52%, and 67%, prolonged Tmax to 3, 4, and 5 hours from 2 hours under fasted conditions, respectively.
Icelandic: Tmax í 4 klst. og fiturík málíð eykur AUC(0-) um 66%, Cmax um 67% og lengir Tmax í 5 klst., úr 2 klst. við töku á fastandi maga.
English: Dolutegravir ↔ AUC ↑ 1% Cmax ↓ 3% Cτ ↓ 8% Tenofovir ↔
Icelandic: Dolutegravír  AUC  1% Cmax  3% Cτ  8% Tenofóvír 
English: No dose adjustment of oral contraceptives is necessary when co-administered with dolutegravir.
Icelandic: Ekki er þörf á aðlögun skammta getnaðarvarnarlyfja til inntöku við notkun samhliða dolutegravíri.
English: No dose adjustment is necessary.
Icelandic: Ekki þörf á skammtaaðlögun.
English: Alternatives to carbamazepine should be used where possible for INI resistant patients.
Icelandic: Nota skal önnur lyf en karbamazepín þegar hægt er hjá INI-ónæmum sjúklingum.
English: Calcium supplements, iron supplements or multivitamins should be taken well separated in time from the administration of dolutegravir (minimum 2 hours after or 6 hours before).
Icelandic: Taka skal fjölvítamín og bætiefni sem innihalda kalsíum eða járn vel aðskilið frá gjöf dolutegravírs (að lágmarki 2 klst. eftir eða 6 klst. fyrir).
English: Daclatasvir did not change dolutegravir plasma concentration to a clinically relevant extent.
Icelandic: Daclatasvír breytti ekki þéttni dolutegravírs í plasma að því marki að það hefði klíníska þýðingu.
English: The clinical status of the patient and the adverse reaction profile of dolutegravir should be borne in mind when considering the patient's ability to drive or operate machinery.
Icelandic: Við mat á hæfni sjúklings til aksturs og notkunar véla skal hafa í huga klínískt ástand sjúklingsins og aukaverkanamynstur dolutegravírs.
English: Anticonvulsants Carbamazepine
Icelandic: Krampaleysandi lyf Karbamazepín
English: Dolutegravir ↔ AUC ↓ 5% Cmax ↑ 16% Cτ ↓ 30% (induction of UGT1A1 and CYP3A enzymes)
Icelandic: Dolutegravír  AUC  5% Cmax  16% Cτ  30% (örvun UGT1A1 og CYP3A ensíma)
English: Missed doses
Icelandic: Glösin innihalda
English: Tivicay 10 mg film-coated tablets
Icelandic: Tivicay 10 mg filmuhúðaðar töflur
English: AUC ↓ 49% Cmax ↓ 33% Cτ ↓ 73%
Icelandic: Dolutegravír  AUC  49% Cmax  33% C  73%
English: Q148 + 1 secondary mutation3
Icelandic: Q148+1 afleidd stökkbreyting b
English: Uncommon Hypersensitivity (see section 4.4) Uncommon Immune Reconstitution Syndrome (see section 4.4)** Psychiatric disorders Common Insomnia Common Abnormal dreams
Icelandic: Ónæmisendurvirkjunarheilkenni (sjá kafla 4.4)**
English: Population PK analyses using pooled pharmacokinetic data from Phase IIb and Phase III adult trials revealed no clinically relevant effect of gender on the exposure of dolutegravir.
Icelandic: Í þýðisgreiningu á lyfjahvörfum úr safni gagna um lyfjahvörf úr rannsóknum á stigum IIb og III hjá fullorðnum komu ekki fram nein áhrif tengd kyni á útsetningu fyrir dolutegravíri er höfðu klíníska þýðingu.
English: The recommended adult dose of dolutegravir is 50 mg twice daily when co-administered with nevirapine.
Icelandic: Ráðlagður skammtur af dolutegravíri handa fullorðnum er 50 mg tvisvar á dag við gjöf samhliða nevírapíni.
English: Median baseline CD4+ was 140 cells/mm3, median duration of prior ART was 14 years, and 56% were CDC Class C. Subjects showed multiple class ART resistance at baseline: 79% had ≥2
Icelandic: 3, miðgildi lengdar fyrri meðferðar með retróveirulyfjum var 14 ár og 56% voru í CDC-flokki C. Einstaklingar sýndu breytilegt ónæmi gegn retróveirulyfjum í upphafi:
English: In adolescents (12 to less than 18 years of age and weighing at least 40 kg) infected with HIV-1 without resistance to the integrase class, the recommended dose of dolutegravir is 50 mg once daily.
Icelandic: 40 kg að þyngd) með HIV-1-sýkingu án ónæmis gegn integrasaflokknum, er 50 mg einu sinni á dag.
English: Analgesics Methadone
Icelandic: Verkjastillandi lyf Metadon
English: In patients infected with HIV-1 without resistance to the integrase class, the recommended dose of dolutegravir in children (6 to less than 12 years of age and weighing at least 15 kg) is determined according to the weight of the child.
Icelandic: Ráðlagður skammtur dolutegravírs hjá börnum (frá 6 ára til yngri en 12 ára og vega að minnsta kosti 15 kg) með HIV-1-sýkingu án ónæmis gegn integrasaflokknum er ákveðinn út frá þyngd barnsins.
English: Overall, the safety profile in patients co-infected with hepatitis B and/or C was similar to that observed in patients without hepatitis B or C co-infection, although the rates of AST and ALT abnormalities were higher in the subgroup with hepatitis B and/or C co-infection for all treatment groups.
Icelandic: Í öllum meðferðarhópum var almennt aukaverkanamynstur hjá sjúklingum með samhliða sýkingu lifrarbólgu B og/eða C svipað og hjá sjúklingum sem ekki voru einnig sýktir af lifrarbólgu B og/eða C.
English: Dolutegravir ↓ AUC ↓ 59% Cmax ↓ 47% Cτ ↓ 76% (induction of UGT1A1 and CYP3A enzymes)
Icelandic: Dolutegravír  AUC  59% Cmax  47% Cτ  76% (örvun UGT1A1 og CYP3A ensíma)
English: Tivicay 10 mg film-coated tablets are white, round, biconvex tablets marked with the code ‘SV 572' on one side and ‘10' on the other side.
Icelandic: Tivicay 10 mg filmuhúðaðar töflur eru hvítar, kringlóttar, tvíkúptar töflur, merktar með „SV 572“ á annarri hliðinni og „10“ á hinni.