FrancophonIA/ELRC3.0 huggingface dataset:
English: Dolutegravir ↓ AUC ↓ 57% Cmax ↓ 39% Cτ ↓ 75%
Icelandic: Dolutegravir  AUC  57% Cmax  39% C  75%
English: If the next dose is due within 4 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
Icelandic: á sjúklingurinn ekki að taka skammtinn sem gleymdist heldur halda áfram samkvæmt venjulegri skammtaáætlun.
English: If Dovato is used in patients co-infected with hepatitis B an additional antiviral is therefore generally needed.
Icelandic: Ef Dovato er notað hjá sjúklingum sem einnig eru sýktir af lifrarbólgu
English: Antacids, to treat indigestion and heartburn, can stop Dovato being absorbed into your body and make it less effective.
Icelandic: Sýrubindandi lyf, við meltingartruflunum og brjóstsviða, geta stöðvað frásog Dovato í líkamanum og dregið úr áhrifum lyfsins.
English: Cmax ↑ 66%
Icelandic: AUC  79% Cmax  66%
English: In animal reproductive toxicology studies with dolutegravir, no adverse development outcomes, including neural tube defects, were identified (see section 5.3).
Icelandic: Í dýrarannsóknum með dolutegraviri á eiturverkun á æxlun komu ekki fram aukaverkanir á þroska, þ.m.t. galli á taugapíplum (sjá kafla 5.3).
English: Lamivudine is predominately cleared by renal excretion of unchanged lamivudine.
Icelandic: Lamivudin er að stærstum hluta losað óbreytt með útskilnaði um nýru.
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: Dolutegravir hafði hvorki stökkbreytandi né litningasundrandi áhrif í in vitro prófum á bakteríum og ræktuðum spendýrafrumum og örkjarnaprófum hjá nagdýrum in vivo.
English: The recommended dose of dolutegravir is 50 mg twice daily when co-administered with rifampicin.
Icelandic: Ráðlagður skammtur dolutegravirs er 50 mg tvisvar sinnum á sólarhring þegar það er gefið samhliða rifampicini.
English: The clinical status of the patient and the adverse reaction profile of Dovato 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 aukaverkanir Dovato.
English: Tablet coating
Icelandic: Tafla með aukaverkunum
English: NAME OF THE MEDICINAL PRODUCT Dovato 50 mg/300 mg film-coated tablets dolutegravir/lamivudine
Icelandic: Dovato 50 mg/300 mg filmuhúðaðar töflur dolutegravir/lamivudin
English: Dolutegravir ↔ AUC ↑ 11% Cmax ↑ 7% Cτ ↑ 28%
Icelandic: Dolutegravir  AUC  11% Cmax  7% C  28%
English: A small amount of the ingredients in Dovato can also pass into your breast milk.
Icelandic: Dovato getur einnig borist í brjóstamjólkina.
English: Magnesium Stearate
Icelandic: Algengar aukaverkanir
English: pancreatitis
Icelandic: liðverkir
English: Dovato should not be taken with any other medicinal product containing dolutegravir or lamivudine, except where a dose adjustment of dolutegravir is indicated due to drug-drug interactions (see section 4.5).
Icelandic: Dovato á ekki að taka samhliða öðru lyfi sem inniheldur dolutegravir eða lamivudin, ef frá er talið þegar ábending er fyrir skammtaaðlögun dolutegravirs vegna lyfjamilliverkana.
English: Do not take an antacid during the 6 hours before you take Dovato, or for at least 2 hours after you take it. You can take other acid-lowering medicines like ranitidine and omeprazole at the same time as Dovato.
Icelandic: Ekki taka sýrubindandi lyf 6 klst. áður en þú tekur Dovato og ekki fyrr en að minnsta kosti 2 klst. eftir að þú tekur lyfið.
English: The apparent volume of distribution of dolutegravir (Vd/F) is 17-20 L. Intravenous studies with lamivudine showed that the mean apparent volume of distribution is 1.3 L/kg.
Icelandic: Rannsóknir með lamivudin í bláæð sýndu að meðaltal sýndardreifingarrúmmáls fyrir lamivudin er 1,3 l/kg.
English: hepatitis
Icelandic: höfuðverkur
English: Double blind therapy will continue up to week 96, followed by open label therapy up to week 148.
Icelandic: 96 með opinni meðferð í kjölfarið fram að viku
English: Antiretroviral medicinal products Non-nucleoside reverse transcriptase inhibitors Etravirine without boosted protease inhibitors /
Icelandic: Bakritahemlar sem ekki eru núkleósíð Etravirin án örvaðra prótasahemla / Dolutegravir
English: There is no evidence that a dose adjustment of dolutegravir or lamivudine would be required based on the effects of race on PK parameters.
Icelandic: Engar vísbendingar eru um að aðlaga þurfi skammta af dolutegraviri eða lamivudini á grundvelli áhrifa kyns á færibreytur lyfjahvarfa.
English: rhabdomyolysis
Icelandic: Jurtalyf
English: Dolutegravir ↓ AUC ↓ 25% Cmax ↓ 12% Cτ ↓ 36%
Icelandic: Dolutegravir  AUC  25% Cmax  12% C  36%
English: Clinical status including liver aminotransferases and bilirubin should be monitored.
Icelandic: Fylgjast á með klínísku ástandi, þ.m.t. lifraramínótransferösum og bilirúbíni.
English: AUC ↑ 79%
Icelandic: Cτ  17%
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: Hjá sjúklingum með HIV sýkingu með alvarlegan ónæmisbrest þegar samsett meðferð með retóveirulyfjum er hafin geta orðið bólguviðbrögð við einkennalausum tækifærissýkingum eða leifum þeirra.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (INDIVIDUAL PACKS ONLY)
Icelandic: YTRI ASKJA (STAKAR PAKKNINGAR EINGÖNGU)
English: Sorbitol
Icelandic:  Sofosbuvir
English: This was supported by the pooled analysis, see Table 3.
Icelandic: Þetta var stutt af safngreiningu, sjá töflu
English: Do not take an antacid during the 6 hours before you take Dovato, or for at least 2 hours after you take it (see also section 3, ‘How to take Dovato')
Icelandic: eftir að þú tekur það (sjá einnig kafla 3, „Hvernig nota á Dovato“)
English: Dovato should not be co-administered with polyvalent cation-containing antacids.
Icelandic: Dovato á ekki að gefa samhliða fjölgildum sýrubindandi lyfjum sem innihalda katjónir.
English: There is no evidence that common polymorphisms in drug metabolising enzymes alter dolutegravir pharmacokinetics to a clinically meaningful extent.
Icelandic: Engin vísbending er um að algengur fjölbreytileiki lyfjaumbrotsensíma breyti lyfjahvörfum dolutegravirs að marki sem hefur klíníska þýðingu.
English: VIIVHIV HEALTHCARE, UNIPESSOAL, LDA Tel: + 351 21 094 08 01 viiv.fi.pt@viivhealthcare.com
Icelandic: + 351 21 094 08 01 viiv.fi.pt@viivhealthcare.com
English: Sulfamethoxazole: AUC ↔
Icelandic: Sulfamethoxazol:
English: • stiffness in the joints
Icelandic: Tafla með samantekt á aukaverkunum
English: A separate preparation of dolutegravir is available where a dose adjustment is indicated due to drug-drug interactions (e.g. rifampicin, carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St. John's wort, etravirine (without boosted protease inhibitors), efavirenz, nevirapine, or tipranavir/ritonavir, see sections 4.4 and 4.5).
Icelandic: Annað lyf með dolutegraviri er fáanlegt þegar ábending er fyrir skammtaaðlögun vegna lyfjamilliverkana (t.d. rifampicin, carbamazepin, oxcarbazepin, phenytoin, phenobarbital, jóhannesarjurt (St.
English: Dolutegravir ↓ AUC ↓ 49% Cmax ↓ 33% Cτ ↓ 73%
Icelandic: Dolutegravir  AUC  49% Cmax  33% C  73%
English: Dolutegravir↓ AUC ↓ 35% Cmax ↓ 24% Cτ ↓ 49%
Icelandic: Dolutegravir AUC  35% Cmax  24% C  49%
English: Renal impairment Pharmacokinetic data have been obtained for dolutegravir and lamivudine separately.
Icelandic: Skert nýrnastarfsemi Upplýsingar um lyfjahvörf dolutegravirs og lamivudins hefur verið aflað sitt í hvoru lagi.
English: Lopinavir ↔ Ritonavir ↔ Etravirine ↔
Icelandic: Lopinavir  Ritonavir  Etravirin 
English: Polymorphisms in drug metabolising enzymes
Icelandic: Lyf við mýkóbakteríum
English: Dolutegravir has a terminal half-life of ~14 hours.
Icelandic: Lokahelmingunartími dolutegravirs er 14 klukkustundir.
English: Very rare side effects that may show up in blood tests are: • a failure of the bone marrow to produce new red blood cells (pure red cell aplasia).
Icelandic: • brestur í framleiðslu mergsins á rauðum blóðfrumum (hreinn rauðkornabrestur (pure red cell aplasia)).
English: • dizziness
Icelandic: • niðurgangur
English: Proton pump inhibitors Omeprazole
Icelandic: Prótónpumpuhemlar Omeprazol
English: Darunavir+ritonavir+etravirine/ Dolutegravir
Icelandic: Darunavir+ritonavir+etravirin/ Dolutegravir
English: (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, area under the concentration versus time curve as “AUC”, maximum observed concentration as “Cmax”).
Icelandic: Milliverkanir dolutegravirs, lamivudins og lyfja sem gefin eru samhliða eru taldar upp í töflu 1 (aukning er gefin til kynna sem „↑“, skerðing sem „↓“, engin breyting sem „↔“, flatarmál undir þéttni-tímaferli sem „AUC“, hámarksþéttni sem „Cmax“).
English: The main adverse reactions reported are haematological disorders (anaemia, neutropenia), and metabolic disorders (hyperlactatemia, hyperlipasemia).
Icelandic: Helstu aukaverkanir sem greint hefur verið frá eru truflanir í blóði (blóðleysi, daufkyrningafæð) og truflanir á efnaskiptum (laktathækkun í blóði, lípasahækkun í blóði).
English: This increase is not considered clinically relevant.
Icelandic: Þessi aukning er ekki talin skipta klínísku máli.
English: * The results of the pooled analysis are in line with those of the individual studies, for which the primary endpoint (difference in proportion <50 copies/mL plasma HIV-1 RNA at Week 48 based on the Snapshot algorithm for dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil /emtricitabine FDC) was met.
Icelandic: * Niðurstöður sameinaðrar greiningar eru hliðstæðar niðurstöðum hvorrar rannsóknar fyrir sig, þar sem aðalendapunktur (mismunur í hlutfalli <50 eintök/ml af ml plasma HIV-1
English: Lopinavir+ritonavir+etravirine/ Dolutegravir
Icelandic: Lopinavir+ritonavir+etravirin/ Dolutegravir
English: Not all pack sizes may be available in your country.
Icelandic: Ekki er víst að báðar pakkningar séu markaðssettar.
English: The recommended dose of dolutegravir is 50 mg twice daily when co-administered with these metabolic inducers.
Icelandic: Ráðlagður skammtur dolutegravirs er 50 mg tvisvar sinnum á sólarhring þegar það er gefið samhliða þessum efnaskiptavirkjum.
English: Dolutegravir and lamivudine are present in cerebrospinal fluid (CSF).
Icelandic: Dolutegravir og lamivudin eru til staðar í heila- og mænuvökva.
English: Data in window and ≥50 copies/mL
Icelandic: RNA <50 eintök/ml
English: Dovato is not recommended for use in combination with emtricitabine
Icelandic: Upplýsingar um Dovato og við hverju það er notað Áður en byrjað er að nota Dovato Hvernig nota á Dovato
English: When administered in fasted state, bioequivalence was achieved for lamivudine AUC, when comparing Dovato to lamivudine 300 mg co-administered with dolutegravir 50 mg. Lamivudine Cmax for Dovato was 32% higher than lamivudine 300 mg co-administered with dolutegravir 50 mg.
Icelandic: Þegar Dovato var borið saman við dolutegravir 50 mg gefið samhliða lamivudini 300 mg við fastandi aðstæður náðist jafngildi með tilliti til Cmax fyrir dolutegravir.
English: The recommended dose of dolutegravir is 50 mg twice daily when co-administered with nevirapine.
Icelandic: Ráðlagður skammtur dolutegravirs er 50 mg tvisvar sinnum á sólarhring þegar það er gefið samhliða nevirapini.
English: Efavirenz ↔ (historical controls) (induction of UGT1A1 and CYP3A enzymes)
Icelandic: Efavirenz  (söguleg viðmiðun) (virkjun UGT1A1 og CYP3A ensíma)
English: 6.2 Incompatibilities
Icelandic: 4.3 Frábendingar
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 dolutegravir í mjólk með þéttni sem var yfirleitt hærri en í blóði.
English: Single dose lamivudine oral solution 300 mg. Lamivudine:
Icelandic: Stakur skammtur af lamivudin mixtúru, lausn 300 mg.
English: The recommended dose of dolutegravir is 50 mg twice daily when co-administered with efavirenz.
Icelandic: Ráðlagður skammtur dolutegravirs er 50 mg tvisvar sinnum á sólarhring þegar það er gefið samhliða efavirenz.
English: Discontinued for lack of efficacy
Icelandic: EÐA ÚRGANGS VEGNA
English: There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally to nucleoside analogues (see section 4.4).
Icelandic: á starfsemi hvatbera hjá HIV-neikvæðum ungbörnum sem útsett voru fyrir núkleósíðahliðstæðum í móðurkviði og/eða eftir fæðingu (sjá kafla
English: These may affect up to 1 in 10,000 people:
Icelandic: Geta komið fram hjá allt að 1 af hverjum 1.000 einstaklingum:
English: • a decreased number of cells involved in blood clotting (thrombocytopenia)
Icelandic: • fækkun frumna sem taka þátt í blóðstorknun (blóðflagnafæð)
English: Calcium supplements/Dolutegravir (fasted intake)
Icelandic: Kalsíumuppbót/Dolutegravir (fastandi inntaka)
English: Nucleoside reverse transcriptase inhibitors (NRTIs) Tenofovir disoproxil
Icelandic: Tenofovir disoproxil
English: Hepatic impairment Pharmacokinetic data has been obtained for dolutegravir and lamivudine separately.
Icelandic: Upplýsingar um lyfjahvörf dolutegravirs og lamivudins hefur verið aflað sitt í hvoru lagi.
English: Dolutegravir ↓ AUC ↓ 22% Cmax ↓ 11% Cτ ↓ 38%
Icelandic: Dolutegravir  AUC  22% Cmax  11% C  38%
English: Dolutegravir ↓ AUC ↓ 59% Cmax ↓ 47% Cτ ↓ 76%
Icelandic: Dolutegravir  AUC  59% Cmax  47%
English: Rilpivirine/Dolutegravir
Icelandic: Rilpivirin/Dolutegravir
English: Effect of dolutegravir: NGMN ↔ AUC ↓ 2% Cmax ↓ 11%
Icelandic: NGMN  AUC  2% Cmax  11%
English: Fertility
Icelandic: Lamivudin
English: Atazanavir ↔ (historical controls) (inhibition of UGT1A1 and CYP3A enzymes)
Icelandic: Atazanavir  (söguleg viðmiðun) (hemlun UGT1A1 og CYP3A ensíma)
English: If you take more Dovato than you should
Icelandic: Þar sem Dovato er tafla með föstum skammti skal gefa
English: • sensation of weakness in the limbs.
Icelandic: • máttleysistilfinning í útlimum.
English: Metabolism and nutrition disorders: Very rare:
Icelandic: Efnaskipti og næring:
English: In reproductive toxicity studies in animals, dolutegravir and lamivudine were shown to cross the placenta.
Icelandic: á æxlun hjá dýrum sýndu að dolutegravir og lamivudin fara yfir fylgju.
English: Dolutegravir ↔ AUC ↑ 1% Cmax ↓ 3% Cτ ↓ 8% Tenofovir ↔
Icelandic: Dolutegravir  AUC  1% Cmax  3% Cτ  8%
English: Fosamprenavir↔ Ritonavir ↔ (induction of UGT1A1 and CYP3A enzymes)
Icelandic: Fosamprenavir Ritonavir  (virkjun UGT1A1 og CYP3A ensíma)
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.
Icelandic: Tíminn sem tilgreindur hefur verið þar til þeir koma fram er samt breytilegur og getur verið margir mánuðir frá því að meðferð er hafin.
English: When taken with food, Dovato and supplements or multivitamins containing calcium, iron or magnesium can be taken at the same time.
Icelandic: Dovato með mat getur þú tekið uppbótarefni eða fjölvítamín sem innihalda kalsíum, járn eða magnesíum á sama tíma og Dovato.
English: Metabolism of lamivudine is a minor route of elimination.
Icelandic: Úthreinsun óbreytts virks efnis um nýru er minniháttar brotthvarfsleið dolutegravirs.
English: Macrogol
Icelandic: sundl
English: Subjects were enrolled with a screening plasma HIV-1 RNA of 1000 c/mL to ≤500,000 c/mL.
Icelandic: RNA við skimun sem nam 1.000 frumur/ml til ≤500.000 frumur/ml.
English: Dolutegravir ↔ AUC ↑ 11% Cmax ↑ 6% Cτ ↑ 17%
Icelandic: Dolutegravir  AUC  11% Cmax  6%
English: Antacid medicines
Icelandic: LYFJAFRÆÐILEGAR
English: Dolutegravir is the predominant circulating compound in plasma; renal elimination of unchanged active substance is low (< 1% of the dose).
Icelandic: Brotthvarf óbreytts virks efnis um nýru er lítið (<1% af skammti).
English: vomiting, flatulence, abdominal pain/ discomfort
Icelandic: uppköst, vindgangur, kviðverkur/óþægindi í kvið
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
Icelandic: Sjá einnig lyfjaupplýsingar fyrir viðkomandi lyf ef um samhliða retróveirulyfjameðferð er að ræða við lifrarbólga B eða C.
English: Anticonvulsants Carbamazepine/Dolutegravir
Icelandic: Krampaleysandi lyf Carbamazepin/Dolutegravir
English: Etravirine ↔ (induction of UGT1A1 and CYP3A enzymes)
Icelandic:  Ritonavir  (virkjun UGT1A1 og CYP3A ensíma)
English: As hepatic elimination plays a minor role in the clearance of lamivudine, drug interactions due to inhibition of OCT1 are unlikely to be of clinical significance.
Icelandic: Ólíklegt er að lyfjamilliverkun vegna hemlunar á OCT1 sé klínískt marktæk þar sem að brotthvarf um lifur skiptir minniháttar máli fyrir úthreinsun lamivudins.
English: No data are available in patients with severe hepatic impairment (Child-Pugh grade C); therefore Dovato should be used with caution in these patients (see section 5.2).
Icelandic: Engar upplýsingar liggja fyrir hjá sjúklingum með verulega skerta lifrarstafsemi (Child-Pugh stig C).
English: There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally to nucleoside analogues, these have predominantly concerned treatment with regimens containing zidovudine.
Icelandic: Greint hefur verið frá starfstruflun í hvatberum hjá HIV neikvæðum ungbörnum sem útsett hafa verið fyrir núkleósíðhliðstæðum í móðurkviði og/eða eftir fæðingu.
English: AUC ↑ 145 %
Icelandic: AUC  145 % Cmax  111%
English: Symptoms of infection and inflammation
Icelandic: Einkenni um sýkingu og bólgu
English: Description of selected adverse reactions
Icelandic: Ráðleggingar um samhliða gjöf
English: No dosage adjustment is considered necessary for patients with mild to moderate hepatic impairment.
Icelandic: Skammtaaðlögun er ekki talin nauðsynleg hjá sjúklingum með vægt eða meðalskerta lifrarstarfsemi.
English: Dolutegravir ↓ (Not studied, a similar reduction in exposure as observed with efavirenz is expected, due to induction)
Icelandic:  (Ekki rannsakað, búist er við svipaðri lækkun útsetningar og kemur fram með efavirenzi vegna virkjunar)
English: Microcrystalline cellulose
Icelandic: Sýkingalyf
English: As Dovato is a fixed-dose tablet, an additional 50 mg tablet of dolutegravir should be administered, approximately 12 hours after Dovato for the duration of the tipranavir/ritonavir co-administration (a separate formulation of dolutegravir is available for this dose adjustment, see section 4.2).
Icelandic: Þar sem Dovato er tafla með föstum skammti skal gefa viðbótartöflu með 50 mg af dolutegraviri u.þ.b. 12 klukkustundum eftir Dovato á meðan á samhliðagjöf tipranavir/ritonavirs stendur (annað lyf með dolutegraviri er fáanlegt vegna þessarar aðlögunar á skammti, sjá kafla 4.2).
English: No dosage adjustment necessary.
Icelandic:  Ekki þarf að aðlaga skammta.
English: When administered in fasted state, bioequivalence regarding Cmax was achieved for dolutegravir, when comparing Dovato to dolutegravir 50 mg co-administered with lamivudine 300 mg. Dolutegravir AUC0-t was 16% higher for Dovato than for dolutegravir 50 mg co-administered with lamivudine 300 mg.
Icelandic: AUC0-t fyrir dolutegravir var 16% hærra fyrir Dovato en fyrir dolutegravir 50 mg ásamt lamivudini 300 mg.
English: Osteonecrosis
Icelandic: Tenofovir 
English: Tipranavir ↔ Ritonavir ↔ (induction of UGT1A1 and CYP3A enzymes)
Icelandic: Darunavir  Ritonavir  (virkjun UGT1A1 og CYP3A ensíma)
English: Antidiabetics Metformin/Dolutegravir
Icelandic: Sykursýkislyf Metformin/Dolutegravir
English: Co-infection with Hepatitis B or C
Icelandic: B eða C (ef þú ert með lifrarbólgu
English: Missed doses
Icelandic: Miðað við skort
English: arthralgia, muscle disorders (including myalgia)
Icelandic: liðverkir, vöðvasjúkdómarar (vöðvaverkir meðtaldir)
English: • hair loss
Icelandic: hár hiti
English: Musculoskeletal and connective tissue disorders: Common:
Icelandic: Stoðkerfi og bandvefur:
English: Effects on electrocardiogram
Icelandic: Áhrif á hjartalínurit
English: In vitro, dolutegravir inhibited the renal transporters OCT2 and MATE1.
Icelandic: In vitro hamlaði dolutegravir OCT2 (lífræna katjónaferja 2) og MATE1 (fjöllyfja- og eiturefnaútþrýstiferja) í nýrum.
English: The absolute bioavailability of dolutegravir has not been established.
Icelandic: Nýting dolutegravirs hefur ekki verið staðfest.
English: General disorders and administration site conditions: Common:
Icelandic: Almennar aukaverkanir og aukaverkanir á íkomustað:
English: As Dovato is a fixed-dose tablet, an additional 50 mg tablet of dolutegravir should be administered, approximately 12 hours after Dovato for the duration of the efavirenz co-administration (a separate formulation of dolutegravir is available for this dose adjustment, see section 4.2).
Icelandic: Þar sem Dovato er tafla með föstum skammti skal gefa viðbótartöflu með 50 mg af dolutegraviri u.þ.b. 12 klukkustundum eftir Dovato á meðan á samhliðagjöf efavirenz stendur (annað lyf meðdolutegraviri er fáanleg vegna þessarar aðlögunar á skammti, sjá kafla 4.2).
English: As Dovato is a fixed-dose tablet, an additional 50 mg tablet of dolutegravir should be administered, approximately 12 hours after Dovato for the duration of the co-administration with these metabolic inducers (a separate formulation of dolutegravir is available for this dose adjustment, see section
Icelandic: Þar sem Dovato er tafla með föstum skammti skal gefa viðbótartöflu með 50 mg af dolutegraviri u.þ.b. 12 klukkustundum eftir Dovato á meðan á samhliðagjöf þessara efnaskiptavirkja stendur (annað lyf með dolutegraviri er fáanleg vegna þessarar aðlögunar á skammti, sjá kafla 4.2).
English: Corticosteroids Prednisone/Dolutegravir
Icelandic: Barksterar Prednison/Dolutegravir
English: PHARMACEUTICAL PARTICULARS
Icelandic: Lyfjamilliverkanir
English: • stomach ache
Icelandic: B. FYLGISEÐILL
English: Effect of dolutegravir: EE ↔ AUC ↑ 3% Cmax ↓ 1%
Icelandic: EE  AUC  3% Cmax  1%
English: Renal impairment
Icelandic: Dovato inniheldur
English: For information around in vitro resistance, and cross resistance to other agents of the integrase- and NRTI class, please refer to the SmPCs of dolutegravir and lamivudine.
Icelandic: Sjá samantekt á eiginleikum lyfs (SmPC) fyrir dolutegravir og lamivudin vegna in vitro ónæmis og krossónæmis fyrir öðrum integrasahemlum og lyfjum í lyfjaflokki NRTI.
English: Antacids and supplements
Icelandic: ÁLETRANIR OG FYLGISEÐILL
English: Atazanavir ↔ Ritonavir ↔
Icelandic: Skert nýrnastarafsemi
English: Hepatic impairment
Icelandic: bráð lifrarbilun
English: • muscle or joint aches.
Icelandic: vöðva- eða liðverkir
English: Dolutegravir ↔ No dosage adjustment necessary.
Icelandic: Ofnæmisviðbrögð Dovato inniheldur dolutegravir.
English: There is no reason to remove it.
Icelandic: Engin ástæða er til þess að fjarlægja hana.
English: Wait 15-30 minutes
Icelandic: Bíddu í 15-30 mínútur
English: Be careful that it does not fall over.
Icelandic: Farið varlega þannig að það detti ekki.
English: You may see an air bubble, and that is okay.
Icelandic: Hugsanlegt er að þú sjáir loftbólu og það er í góðu lagi.
English:  Remember to wash your hands!
Icelandic: Mundu að þvo þér um hendurnar!
English: Open.
Icelandic: Opnið.
English: Use a plaster if you want to.
Icelandic: Notið plástur ef þarf.
English: • Several seconds later you may hear a 2nd click.
Icelandic: • Nokkrum sekúndum síðar heyrist hugsanlega annar smellur.
English: Fewer than half of at-risk subjects had an event
Icelandic: Færri en helmingur sjúklinga í hættu fengu tilvik
English: You may hear a 1st click.
Icelandic: Þú heyrir hugsanlega einn smell.
English: DO NOT use the same site that was used for the last injection.
Icelandic: EKKI nota sama stað og notaður var fyrir síðustu inndælingu.