FrancophonIA/ELRC3.0 huggingface dataset:
English: Cmax: ↑17%* (↑8 to ↑27)
Icelandic: ↑ 17%* (↑ 8 til ↑ 27) Cmin:
English: Table 1: Paediatric dose to be administered once daily*
Icelandic: Barnaskammtar sem gefa skal einu sinni á dag*
English: or infant formula.
Icelandic: jógúrt eða ungbarnamjólkurblanda.
English: Simvastatin: AUC: ↓ 69% (↓ 62 to ↓ 73)
Icelandic: ↓ 69% (↓ 62 til ↓ 73)
English: Cmin: ↓ 25% (↓ 14 to ↓ 34)%
Icelandic: ↓ 25% (↓ 14 til ↓ 34)% Efavírenz:
English: EU/1/99/110/003: bottle EU/1/99/110/004: blister
Icelandic: MARKAÐSLEYFISNÚMER EU/1/99/110/003 - glas EU/1/99/110/004 - þynnupakkning
English: Refer to the prescribing information for sofosbuvir/velpatasvir for more information.
Icelandic: Frekari lyfjaupplýsingar má finna í upplýsingum um sofosbuvir/velpatasvir.
English: Each hard capsule contains 200 mg of efavirenz.
Icelandic: Hvert hart hylki inniheldur 200 mg af efavírenzi.
English: Efavirenz is a NNRTI of HIV-1.
Icelandic: Efavírenz er HIV-1 bakritahemill, sem ekki er núkleósíð (NNRTI).
English: Hepatitis C antivirals Boceprevir/Efavirenz (800 mg 3 times daily/600 mg once daily)
Icelandic: C Boceprevir/efavírenz (800 mg 3svar á dag/600 mg einu sinni á dag)
English: Co-administration of efavirenz with the fixed combination tablet containing efavirenz, emtricitabine, and tenofovir disoproxil is not recommended unless needed for dose adjustment (for example, with rifampicin).
Icelandic: Ekki er mælt með samhliða notkun efavírenz og töflu sem inniheldur ákveðna samsetningu af efavírenz, emtrícítabín og tenófóvír dísóproxíl fúmarati nema þörf sé á skammtaaðlögun (t.d. með rífampicíni).
English: * When compared to atazanavir 300 mg/ritonavir 100 mg once daily in the evening without efavirenz.
Icelandic: * Þegar miðað er við atazanavír 300 mg/ ritonavír 100 mg daglega að kvöldi
English: one 200 mg capsule
Icelandic: eitt 200 mg hylki
English: Sertraline dose increases should be guided by clinical response.
Icelandic: Haga ætti skammtaaukningu sertralíns eftir klínískri svörun.
English: Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at increased risk for severe and potentially fatal hepatic adverse reactions.
Icelandic: B eða C sem fá samsetta andretróveirumeðferð eru í aukinni hættu á að fá alvarlega og jafnvel lífshættulegar aukaverkanir í lifur.
English: Each hard capsule contains 50 mg of efavirenz.
Icelandic: Hvert hart hylki inniheldur 50 mg af efavírenzi.
English: The pharmacokinetic parameters for efavirenz at steady state in paediatric patients were predicted by a population pharmacokinetic model and are summarized in Table 5 by weight ranges that correspond to the recommended doses.
Icelandic: Spáð var fyrir um lyfjahvarfabreytur efavírenz við jafnvægi hjá börnum með því að beita líkani fyrir lyfjahvörf hjá tilteknu þýði og eru niðurstöðurnar dregnar saman í töflu 5 í þyngdarflokkum sem samsvara ráðlögðum skömmtum.
English: 6.5 Nature and content of container
Icelandic: 6.5 Gerð íláts og innihald
English: AUC: ↓ 36% C12: ↓ 21%
Icelandic: ↓ 36% C12:
English: Cmax: ↑ 49% (↑ 32 to ↑ 69)
Icelandic: ↑ 49% (↑ 32 til ↑ 69) Efavírenz:
English: Refer to the prescribing information for velpatasvir/sofosbuvir/ voxilaprevir for more information.
Icelandic: Frekari upplýsingar má finna í lyfjaupplýsingum um velpatasvir/sofosbuvir/ voxilaprevir.
English: Cmin: ↓ 63% (↓ 44 to ↓ 75) Desacetyl diltiazem:
Icelandic: ↓ 62% (↓ 44 til ↓ 75) N-mónódesmetýl diltíazem:
English: NOREPINEPHRINE AND DOPAMINE REUPTAKE INHIBITOR Bupropion/Efavirenz [150 mg single dose (sustained release)/600 mg once daily]
Icelandic: Noradrenalín og dópamín endurupptökuhemill Búprópíon/Efavírenz [150 mg stakur skammtur (forðalyf)/600 mg einu sinni á sólarhring]
English: Your doctor may give you a different anticonvulsant.
Icelandic: Læknirinn gæti þurft að gefa þér annað flogaveikilyf
English: Concomitant administration of efavirenz with elbasvir/grazoprevir is contraindicated because it may lead to loss of virologic response to elbasvir/grazoprevir.
Icelandic: Ekki má nota efavirenz samhliða elbasviri/grazopreviri þar sem það getur leitt til minnkaðrar veirusvörunar við elbasviri/grazopreviri.
English: INFORMATION IN BRAILLE SUSTIVA 600 mg
Icelandic: MEÐ BLINDRALETRI SUSTIVA 600 mg
English: Lopinavir concentrations: ↓ 30-40% Lopinavir concentrations: similar to lopinavir/ritonavir 400/100 mg twice daily without efavirenz
Icelandic: Lópinavírþéttni: svipuð og lópinavír/rítonavír 400/100 mg tvisvar á dag án efavírenz
English: Injection:
Icelandic: Atorvastatín:
English: Other medicines and SUSTIVA
Icelandic: Notkun annarra lyfja samhliða SUSTIVA
English: Coadministration of glecaprevir/pibrentasvir with efavirenz is not recommended (see section 4.5).
Icelandic: Ekki er mælt með samhliðanotkun glecaprevirs/pibrentasvirs og efavirenz (sjá kafla 4.5).
English: White, printed with "SUSTIVA" on the body and "100 mg" on the cap. SUSTIVA 200 mg hard capsules
Icelandic: Hvít, með áletruninni „SUSTIVA“ á öðrum helmingnum og „100 mg“ á hinum helmingnum.
English: Dose adjustment of atorvastatin may be required (refer to the Summary of Product Characteristics for atorvastatin).
Icelandic: Nauðsynlegt getur verið að aðlaga skammtastærð atorvastatíns (vísað til samantektar á eiginleikum lyfs fyrir atorvastatín).
English: Efavirenz in combination with darunavir/ritonavir 800/100 mg once daily may result in suboptimal darunavir Cmin.
Icelandic: Samsett meðferð með efavírenzi ásamt darunavíri/ritonavíri 800/100 mg einu sinni á sólarhring getur leitt til þess að Cmin verði undir kjörgildi.
English: Each SUSTIVA film-coated tablet contains 600 mg of the active substance efavirenz.
Icelandic: Hver SUSTIVA filmuhúðuð tafla inniheldur 600 mg af virka efninu efavírenz.
English: Other interactions: efavirenz does not bind to cannabinoid receptors.
Icelandic: Efavírenz binst ekki við kannabínóíðviðtaka.
English: OTHER
Icelandic: a
English: The capsules are printed with inks containing cochineal carminic acid (E120), indigo carmine (E132), and titanium dioxide (E171).
Icelandic: Á hylkin er prentað með bleki sem inniheldur karmín (E120), indigotín (E132) og títantvíoxíð (E171).
English: Efavirenz levels may increase on stopping St. John's wort and the dose of efavirenz may need adjusting.
Icelandic: Efavírenz þéttni getur hækkað þegar notkun jóhannesarjurtar er hætt og því gæti þurft að aðlaga skammtinn af efavírenzi.
English: Nervous system symptoms usually begin soon after therapy onset and generally resolve after the first 2 - 4 weeks.
Icelandic: Einkenni frá taugakerfi byrja vanalega fljótlega eftir upphaf meðferðar og batna oftast eftir 2-4 vikur.
English: Clinically significant interactions are not expected since the NRTIs are metabolised via a different route than efavirenz and would be unlikely to compete for the same metabolic enzymes and elimination pathways.
Icelandic: Klínískt marktækar milliverkanir eru ekki líklegar þar sem núkleósíð bakritahemlar (NRTI lyf) umbrotna eftir öðrum ferli en efavírenz og er því ólíklegt að um samkeppni sé að ræða um umbrotaensím og brotthvarfsleiðir.
English: Compounds that are substrates of these enzymes may have decreased plasma concentrations when co-administered with efavirenz.
Icelandic: Plasmaþéttni efnasambanda sem eru hvarfefni þessara ensíma getur lækkað þegar þau eru gefin samhliða efavírenzi.
English: SUSTIVA 100 mg hard capsules
Icelandic: SUSTIVA 100 mg hörð hylki
English: Each hard capsule contains 100 mg of efavirenz.
Icelandic: Hvert hart hylki inniheldur 100 mg af efavírenzi.
English: HORMONAL CONTRACEPTIVES Oral:
Icelandic: GETNAÐARVARNALYF MEÐ HORMÓNUM Til inntöku:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/110/001-004
Icelandic: MARKAÐSLEYFISNÚMER EU/1/99/110/001-004
English: NNRTIs/Efavirenz
Icelandic: Flúoxetín/Efavírenz
English: At baseline, median plasma HIV-1 RNA was 5.88 log10 copies/mL, median CD4+ cell count was 1144 cells/mm3, and median CD4+ percentage was 25%.
Icelandic: Við grunngildi var plasmamiðgildi HIV-1 RNA 5,88 log10 eintök/ml, miðgildi frumufjölda CD4+ 1.144
English: This may make some side effects (for example, dizziness, drowsiness) less troublesome.
Icelandic: Þetta getur minnkað áhrif sumra aukaverkana (svo sem sundls, sljóleika).
English: Efavirenz has a relatively long terminal half-life of at least 52 hours after single doses and 4055 hours after multiple doses.
Icelandic: 52 klukkustundir eftir einn stakan skammt og 40 - 55 klukkustundir eftir endurtekna skammta.
English: Efavirenz may cause dizziness, impaired concentration, and/or somnolence.
Icelandic: Efavírenz getur valdið svima, skertri einbeitingu og/eða svefnhöfga.
English: They include some common medicines and a herbal remedy (St. John's wort) which can cause serious interactions.
Icelandic: Þetta eru nokkur almenn lyf og náttúruefni (Jóhannesarjurt) sem geta valdið alvarlegum milliverkunum.
English: three 100 mg capsules
Icelandic: þrjú 100 mg hylki
English: Concomitant administration of velpatasvir/sofosbuvir/ voxilaprevir with efavirenz is not recommended (see section 4.5).
Icelandic: Ekki er mælt með samhliða notkun velpatasvirs/sofosbuvirs/voxilaprevirs og efavirenz (sjá kafla 4.5).
English: Hepatic impairment
Icelandic: Líkamsþyngd efavírenz
English: three 100 mg capsules + one 50 mg capsule
Icelandic: þrjú 100 mg hylki + eitt 50 mg hylki
English: Coadministration of higher doses of either efavirenz or carbamazepine has not been studied.
Icelandic: Samhliða gjafir hærri skammta af annaðhvort efavírenz eða karbamazepíni hafa ekki verið rannsakaðar.
English: SIA Merck Sharp & Dohme Latvija Tel: +371 67364 224 msd_lv@merck.com
Icelandic: Tel: +371 67364 224 msd_lv@merck.com
English: cells/mm (S.E.M.
Icelandic: (S.E.M.d)
English: Printing ink: Cochineal carminic acid (E120), Indigo carmine (E132), Titanium dioxide (E171)
Icelandic: Karmín (E120), Indigotín (E132), Títantvíoxíð (E171).
English: Dose adjustments of calcium channel blockers should be guided by clinical response (refer to the Summary of Product Characteristics for the calcium channel blocker).
Icelandic: Skammtaaðlögun kalsíumgangaloka skal ráðast af klínískri svörun (vísað til samantektar á eiginleikum lyfs fyrir viðeigandi kalsíumgangaloka).
English: On the basis of the scientific conclusions for efavirenz the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing efavirenz is unchanged subject to the proposed changes to the product information
Icelandic: Ástæður fyrir breytingum á skilmálum markaðsleyfisins Á grundvelli vísindalegra niðurstaðna fyrir efavírenz telur CHMP að jafnvægið á milli ávinnings og áhættu af lyfinu, sem inniheldur efavírenz, sé óbreytt að því gefnu að áformaðar breytingar á lyfjaupplýsingunum séu gerðar.
English: SUSTIVA 200 mg hard capsules can be taken by children and adolescents 3 months of age and older and weighing at least 3.5 kg who are able to swallow the capsules.
Icelandic: SUSTIVA 200 mg hörð hylki má nota fyrir börn og unglinga, 3 mánaða og eldri sem eru a.m.k.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Bristol-Myers Squibb Pharma EEIG
Icelandic: NAFN MARKAÐSLEYFISHAFA Bristol-Myers Squibb Pharma EEIG
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 90 (3 packs of 30 x 1) film-coated tablets
Icelandic: 90 (3 pakkar með 30 x 1) filmuhúðuðum töflum
English: Tablet core
Icelandic: Klínísk virkni
English: Each SUSTIVA hard capsule contains 200 mg of the active substance efavirenz.
Icelandic: Hvert hart hylki af SUSTIVA inniheldur 200 mg af virka efninu efavírenz.
English: The potential for cross-resistance between efavirenz and NRTIs is low because of the different binding sites on the target and mechanism of action.
Icelandic: Líkurnar á krossónæmi milli efavírenz og NRTI lyfja eru einnig litlar en þar er um mismunandi bindistaði að ræða svo og annan verkunarhátt.
English: If you could get pregnant while receiving SUSTIVA, you need to use a reliable form of barrier contraception (for example, a condom) with other methods of contraception including oral (pill) or other hormonal contraceptives (for example, implants, injection).
Icelandic: Séu líkur á að þú verðir þunguð meðan á SUSTIVA meðferð stendur skal örugg hindrandi getnaðarvörn (t.d. smokkur) ávallt notuð samhliða öðrum getnaðarvörnum s.s. getnaðarvarnartöflum og öðrum hormónagetnaðarvörnum (s.s. ígræddum getnaðarvörnum og getnaðarvarnarsprautum).
English: Nelfinavir/Efavirenz (750 mg q8h/600 mg once daily)
Icelandic: Nelfínavír/Efavírenz (750 mg q8h/600 mg einu sinni á dag)
English: SUSTIVA 50 mg hard capsules can be taken by children and adolescents 3 months of age and older and weighing at least 3.5 kg who are able to swallow the capsules.
Icelandic: SUSTIVA 50 mg hörð hylki má nota börn og unglinga, 3 mánaða og eldri sem eru a.m.k.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains: efavirenz 50 mg.
Icelandic: VIRK(T) EFNI Hver hart hylki inniheldur: efavírenz 50 mg
English: Efavirenz must not be used as a single agent to treat HIV or added on as a sole agent to a failing regimen.
Icelandic: Efavírenz má ekki gefa eitt sér til meðferðar við HIV sýkingu og ekki má bæta því einu sér við meðferð sem ekki ber árangur.
English: What SUSTIVA looks like and contents of the pack SUSTIVA 50 mg hard capsules are supplied in bottles of 30 capsules.
Icelandic: SUSTIVA 50 mg hörð hylki eru í glösum sem innihalda 30 hylki.
English: Famotidine/Efavirenz (40 mg single dose/400 mg single dose)
Icelandic: Famótidín/Efavírenz (40 mg stakur skammtur/400 mg stakur skammtur)
English: one 200 mg capsule + one 50 mg capsule
Icelandic: eitt 200 mg hylki + eitt 50 mg hylki
English: Dose adjustment of pravastatin may be required (refer to the Summary of Product Characteristics for pravastatin).
Icelandic: Nauðsynlegt getur verið að aðlaga skammtastærð pravastatíns (vísað til samantektar á eiginleikum lyfs fyrir pravastatín).
English: There is a potential for reduction or increase in the plasma concentrations of phenytoin, phenobarbital and other anticonvulsants that are substrates of CYP450 isoenzymes when coadministered with efavirenz.
Icelandic: Þegar fenýtóín, fenóbarbítal og önnur krampastillandi lyf, sem eru hvarfefni fyrir CYP450 ísóensím, eru gefin ásamt efavírenz er hugsanlegt að plasmaþéttni þeirra lækki eða aukist.
English: one 100 mg capsule + one 50 mg capsule
Icelandic: eitt 100 mg hylki + eitt 50 mg hylki
English: Merck Sharp & Dohme (Sweden) AB Tel: +46 (0)77 5700488 medicinskinfo@merck.com
Icelandic: Tel: +46 (0)77 5700488 medicinskinfo@merck.com
English: Selective Serotonin Reuptake Inhibitors (SSRIs) Sertraline/Efavirenz (50 mg once daily/600 mg once daily)
Icelandic: Sérhæfðir serótónín endurupptökuhemlar (SSRI lyf) Sertralín/Efavírenz (50 mg einu sinni á dag/600 mg einu sinni á dag)
English: Table 2: Interactions between efavirenz and other medicinal products in adults
Icelandic: Milliverkanir efavírenz og annarra lyfja hjá fullorðnum
English: The biliary hyperplasia regressed upon cessation of dosing.
Icelandic: Einkenni gallvegastækkunar gengu til baka þegar meðferð var hætt.
English: Paroxetine/Efavirenz (20 mg once daily/600 mg once daily)
Icelandic: Paroxetín/Efavírenz (20 mg einu sinni á dag/600 mg einu sinni á dag)
English: Nervous system symptoms
Icelandic: Einkenni frá taugakerfi
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains: efavirenz 100 mg.
Icelandic: VIRK(T) EFNI Hver hart hylki inniheldur: efavírenz 100 mg
English: ANTIANXIETY AGENTS Lorazepam/Efavirenz (2 mg single dose/600 mg once daily)
Icelandic: KVÍÐASTILLANDI LYF Lorazepam/Efavírenz (2 mg stakur skammtur/600 mg einu sinni á dag)
English: Lorazepam: AUC: ↑ 7% (↑ 1 to ↑ 14)
Icelandic: Morgunn AUC: ↑ 18% (↑ 6 til ↑ 33)
English: Medicines used to treat malaria: artemether/lumefantrine: SUSTIVA may reduce the amount of artemether/lumefantrine in your blood.
Icelandic: SUSTIVA getur minnkað magn artemeters/lumefantríns í blóðinu
English: Atovaquone and proguanil hydrochloride/Efavirenz (250/100 mg single dose/600 mg once daily)
Icelandic: Atóvakón og prógúaníl hýdróklóríð/Efavírenz (250/100 mg stakur skammtur/600 mg einu sinni á sólarhring)
English: You should consult your doctor if you have a rash, since some rashes may be serious; however, most cases of rash disappear without any change to your treatment with SUSTIVA.
Icelandic: Þú ættir að ráðfæra þig við lækninn ef þú færð útbrot þar sem sum útbrot geta verið alvarleg.
English: Plasma levels of efavirenz can be reduced by concomitant use of St. John's wort due to induction of drug metabolising enzymes and/or transport proteins by St. John's wort.
Icelandic: Þéttni efavírenz í plasma getur lækkað með samhliða notkun jóhannesarjurtar vegna örvunar jóhannesarjurtar á umbrotaensímum og/eða flutningspróteinum.
English: Cmax: ↓ 37% (↓ 20 to ↓ 51)
Icelandic: ↓ 37% (↓ 20 til ↓ 51) Cmin:
English: Each SUSTIVA hard capsule contains 100 mg of the active substance efavirenz.
Icelandic: Hvert hart hylki af SUSTIVA inniheldur 100 mg af virka efninu efavírenz.
English: Nervous system symptoms usually begin during the first one or two days of therapy and generally resolve after the first 2 - 4 weeks.
Icelandic: Einkenni frá taugakerfi koma yfirleitt fram á fyrsta eða öðrum degi meðferðar og hverfa yfirleitt aftur eftir fyrstu 2 - 4 vikurnar.
English: Implant: Etonogestrel/Efavirenz Decreased exposure of etonogestrel may be expected (CYP3A4 induction).
Icelandic: Búast má við minnkaðri útsetningu á etónógestrel (CYP3A4 örvun).
English: one 100 mg capsule
Icelandic: eitt 100 mg hylki
English: Gastrointestinal disorders common abdominal pain, diarrhoea, nausea, vomiting uncommon pancreatitis
Icelandic: Meltingarfæri algengar kviðverkir, niðurgangur, ógleði, uppköst sjaldgæfar brisbólga
English: Coadministration of sofosbuvir/velpatasvir with efavirenz is not recommended (see section 4.5).
Icelandic: Ekki er mælt með samhliða notkun sofosbuvirs/velpatasvirs og efavirenz (sjá kafla 4.5).
English: Other medicines used for HIV infection: protease inhibitors: darunavir, indinavir, lopinavir/ritonavir, ritonavir, ritonavir boosted atazanavir, saquinavir or fosamprenavir/saquinavir.
Icelandic: − próteasahemlar: darunavír, indinavír, lópinavír/ritonavír, ritonavír, ritonavír aukið atazanavír, saquinavír eða fosamprenavír/saquinavír.
English: The pharmacokinetic parameters for efavirenz at steady state in paediatric patients were predicted by a population pharmacokinetic model and are summarized in Table 4 by weight ranges that correspond to the recommended doses.
Icelandic: Spáð var fyrir um lyfjahvarfabreytur efavírenz við jafnvægi hjá börnum með því að beita líkani fyrir lyfjahvörf hjá tilteknu þýði og eru niðurstöðurnar dregnar saman í töflu 4 í þyngdarflokkum sem samsvara ráðlögðum skömmtum.
English: The median increase from baseline in CD4+ count at 48 weeks of therapy was 238 cells/mm3 and the median increase in
Icelandic: Miðgildi fjölgunar frá grunngildi við CD4+ frumutalningu í 48. viku var 215 frumur/mm3
English: The other ingredients of the tablet core are: croscarmellose sodium, microcrystalline cellulose, sodium laurilsulfate, hydroxypropylcellulose, lactose monohydrate, and magnesium stearate.
Icelandic: Natríumkroskarmellósi, míkrókristallaður sellulósi, natríumlárýlsúlfat, hýdroxýprópýlsellulósi, laktósaeinhýdrat og magnesíumsterat.
English: What SUSTIVA looks like and contents of the pack SUSTIVA 100 mg hard capsules are supplied in bottles of 30 capsules.
Icelandic: SUSTIVA 100 mg hörð hylki eru í glösum sem innihalda 30 hylki.
English: Hormonal contraceptive, such as birth control pills, an injected contraceptive (for example, Depo-Provera), or a contraceptive implant (for example, Implanon): you must also use a reliable barrier method of contraception (see Pregnancy,breast-feeding and fertility).
Icelandic: Getnaðarvarnarlyf með hormónum, svo sem getnaðarvarnartöflur, getnaðarvarnarlyf til inndælingar (til dæmis Depo-Provera) eða getnaðarvarnarlyf sem sett er í vef (til dæmis Implanon):
English: Cmin: ↓ 47% (↓ 41 to ↓ 53) (decrease in carbamazepine concentrations: CYP3A4 induction; decrease in efavirenz concentrations: CYP3A4 and CYP2B6 induction)
Icelandic: CYP3A4 örvun; minnkun á þéttni efavírenz: CYP3A4 og CYP2B6 örvun)
English: Norbuprenorphine:
Icelandic: ↓ 50% Norbúprenorfín:
English: Medicines used to treat convulsions/seizures (anticonvulsants): carbamazepine, phenytoin, phenobarbital.
Icelandic: Lyf notuð til meðhöndlunar á krömpum/flogum (flogaveikilyf): karbamazepín, fenýtóin, fenóbarbital.
English: Capsule core: Sodium laurilsulfate, Lactose monohydrate, Magnesium stearate, Sodium starch glycolate
Icelandic: Natríumlaurýlsúlfat, Laktósaeinhýdrat, Magnesíumsterat, Natríumglýkólatsterkja Hylkisskel:
English: Cmax: ↓ 80% (↓ 77 to ↓ 83)
Icelandic: ↓ 80% (↓ 77 til ↓ 83) Cmin:
English: FURTHER INFORMATION
Icelandic: 16. UPPLÝSINGAR
English: AUC: ↓ 18% (↓ 10 to ↓ 26) Cmax: ↓ 24% (↓ 15 to ↓ 32)
Icelandic: ↓ 26% (↓ 15 til ↓ 36) Cmax: ↓ 20% (↓ 11 til ↓ 28) Cmin:
English: INFORMATION IN BRAILLE SUSTIVA 200 mg
Icelandic: MEÐ BLINDRALETRI SUSTIVA 200 mg
English: If efavirenz is to be used in combination with darunavir/ritonavir, the darunavir/ritonavir 600/100 mg twice daily regimen should be used.
Icelandic: Ef nota á efavírenz í samsettri meðferð með darunavíri/ritonavíri skal gefa darunavír/ritonavír 600/100 mg tvisvar á sólarhring.
English: CD4+ cell count was 755 cells/mm3, and median CD4+ percentage was 30%.
Icelandic: frumur/mm3 og miðgildi hundraðshluta CD4+ var 25%.
English: A reliable method of barrier contraception must be used in addition to hormonal contraceptives (see section 4.6).
Icelandic: Nota skal örugga hindrandi getnaðarvörn auk getnaðarvarnarlyfja með hormónum (sjá kafla 4.6).
English: SUSTIVA 100 mg hard capsules can be taken by children and adolescents 3 months of age and older and weighing at least 3.5 kg who are able to swallow the capsules.
Icelandic: SUSTIVA 100 mg hörð hylki má nota nota fyrir börn og unglinga, 3 mánaða og eldri sem eru a.m.k.
English: Cmax: ↓ 60% (↓ 50 to ↓ 68)
Icelandic: ↓ 60% (↓ 52 til ↓ 68) Cmax:
English: Despite the decrease in buprenorphine exposure, no patients exhibited withdrawal symptoms.
Icelandic: Enginn sjúklingur sýndi fráhvarseinkenni þrátt fyrir minnkaða útsetningu á búprenorfíni
English: *compared to 200 mg twice daily alone ** compared to 600 mg once daily alone (competitive inhibition of oxidative metabolism)
Icelandic: ↔** *samanborið við 200 mg tvisvar á dag, eitt sér ** samanborið við 600 mg einu sinni á dag, eitt sér.
English: CCR5 antagonist Maraviroc/Efavirenz (100 mg twice daily/600 mg once daily)
Icelandic: Maraviroc/Efavírenz (100 mg tvisvar á dag/600 mg einu sinni á dag)
English: SUSTIVA can reduce the amount of statins in your blood.
Icelandic: SUSTIVA getur minnkað magn statína í blóðinu.
English: No clinically significant pharmacokinetic change.
Icelandic: Engar klínískt marktækar breytingar á lyfjahvörfum.
English: Mean percent change in AUC, Cmax,
Icelandic: Meðal prósentubreyting á AUC, Cmax, Cmin ásamt öryggisbili sé það til staðara
English: BATCH NUMBER Lot
Icelandic: 13. LOTUNÚMER A Lot
English: If you take too much SUSTIVA contact your doctor or nearest emergency department for advice.
Icelandic: Ef tekinn er stærri skammtur en mælt er fyrir um Ef þú tekur inn of mikið af SUSTIVA hafðu samband við skaltu ráðfæra þig við lækninn eða næsta hafa samband við sjúkrahús til að fá ráð.
English: NAME OF THE MEDICINAL PRODUCT SUSTIVA 600 mg film-coated tablets
Icelandic: HEITI LYFS SUSTIVA 600 mg filmuhúðaðar töflur.
English: Cmax: ↑ 11% (↑ 3 to ↑ 19)
Icelandic: ↑ 34% (↑ 18 til ↑ 53)
English: - severe disturbances of electrolyte balance e.g. hypokalemia or hypomagnesemia.
Icelandic: verulegar truflanir á blóðsaltajafnvægi t.d. blóðkalíumlækkun eða blóðmagnesíumlækkun.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 600 mg of efavirenz.
Icelandic: Hver filmuhúðuð tafla inniheldur 600 mg af efavírenzi.
English: INFORMATION IN BRAILLE SUSTIVA 100 mg
Icelandic: MEÐ BLINDRALETRI SUSTIVA 100 mg
English: Propylene glycol
Icelandic: SÝKINGALYF
English: Voriconazole/Efavirenz (400 mg twice daily/300 mg once daily)
Icelandic: Vorikónazól/Efavírenz (400 mg tvisvar á dag/300 mg einu sinni á dag)