FrancophonIA/ELRC3.0 huggingface dataset:
English: Lipid disorders should be managed as clinically appropriate.
Danish: Tilstande med forhøjet lipid skal behandles som klinisk indiceret.
English: 006 on a subset of 614 patients who had been enrolled for at least 48 weeks are found in Table 2.
Danish: I Table 2 ses effektresultaterne for Undersøgelse 006, for en undergruppe af 614 patienter, som havde været inkluderet i mindst 48 uger.
English: Dose adjustment of atorvastatin may be required (refer to the Summary of Product Characteristics for atorvastatin).
Danish: Dosisjustering af atorvastatin kan være påkrævet (se SPC for atorvastatin).
English: Among co-infected patients in study 006, elevations in AST to greater than five times ULN developed in 13% of efavirenz-treated patients and in 7% of control, and elevations in ALT to greater than five times ULN developed in 20% and 7%, respectively.
Danish: Blandt co-inficerede patienter i undersøgelse 006 steg ASAT mere end fem gange ULN hos 13% af de patienter, der fik efavirenz, og hos 7% af patienterne i kontrolgruppen, og ALAT steg mere end fem gange ULN hos henholdsvis 20% og 7%.
English: In a taste preference study in adults, SUSTIVA mixed with grape jelly received the best rating.
Danish: I et forsøg om smagspræference hos voksne, fik
English: No clinically significant pharmacokinetic change.
Danish: Ingen klinisk signifikant farmakokinetisk forandring.
English: No clinically significant pharmacokinetic interaction.
Danish: Ingen klinisk signifikant farmakokinetisk interaktion.
English: Concomitant administration of simeprevir with efavirenz resulted in significantly decreased plasma concentrations of simeprevir due to CYP3A induction by efavirenz, which may result in loss of therapeutic effect of simeprevir.
Danish: Samtidig administration af simeprevir og efavirenz resulterede i signifikant nedsat plasma-simeprevir som følge af CYP3A-induktion forårsaget af efavirenz, hvilket kan resultere i et tab af terapeutisk effekt af simeprevir.
English: Concomitant use of Ginkgo biloba extracts is not recommended (see section 4.5).
Danish: Samtidig brug af Ginkgo biloba frarådes (se pkt.
English: The safety and efficacy of efavirenz in children below the age of 3 months or weighing less than 3.5 kg have not been established.
Danish: Efavirenz' sikkerhed og virkning hos børn under 3 måneder, eller børn der vejer under 3,5 kg, er ikke klarlagt.
English: if you have a history of convulsions (fits or seizures) or if you are being treated with anticonvulsant therapy such as carbamazepine, phenobarbital and phenytoin.
Danish: - hvis De tidligere har haft krampeanfald, eller hvis De får medicin mod krampeanfald, for eksempel carbamazepin, phenobarbital og phenytoin.
English: - methadone.
Danish: Methadon:
English: Reproductive system and breast disorders uncommon gynaecomastia
Danish: Det reproduktive system og mammae Ikke almindelig
English: cells/mm (S.E.M.
Danish: celler/mm3 (S.E.M.
English: Efavirenz may cause dizziness, impaired concentration, and/or somnolence.
Danish: Efavirenz kan forårsage svimmelhed, nedsat koncentrationsevne og/ellerdøsighed.
English: Posaconazole/Efavirenz --/400 mg once daily
Danish: Posaconazol/efavirenz --/400 mg én gang dagligt
English: Co-administration of simeprevir with efavirenz is not recommended.
Danish: Samtidig administration af simeprevir og efavirenz frarådes.
English: What SUSTIVA looks like and contents of the pack SUSTIVA 600 mg film-coated tablets are supplied in bottles of 30 tablets.
Danish: SUSTIVA 600 mg filmovertrukne tabletter fås i flasker med 30 tabletter.
English: Using an ITT analysis, the overall proportions of patients with HIV RNA <400 copies/mL and <50 copies/mL at Week 48 were 77% (33/43) and 70% (30/43), respectively.
Danish: Ved brug af ITT-analyse var andelen af patienter med hiv-RNA <400 kopier/ml og <50 kopier/ml ved uge 48 henholdsvis 77% (33/43) og 70% (30/43).
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).
Danish: Efavirenz og den faste kombinationstablet indeholdende efavirenz, emtricitabin og tenofovirdisoproxil, bør ikke administreres samtidigt medmindre det er nødvendigt for dosisjustering (fx ved samtidig behandling med rifampicin).
English: < 400 copies/ml (95% C.I.
Danish: < 400 kopier/ml (95% C.I.
English: Other macrolide antibiotics (e.g.,erythromycin)/Efavirenz
Danish: Andre makrolidantibiotika (fx erythromycin)/efavirenz
English: Table 4: Predicted steady-state pharmacokinetics of efavirenz (capsules/capsule sprinkles) in HIV-infected paediatric patients Body Weight
Danish: Tabel 4: Efavirenz' forudsagte farmakokinetik ved steady rate (kapsler/kapselpulver) hos hivinficerede pædiatriske patienter
English: If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.
Danish: De skal straks informere Deres læge for at få den nødvendige behandling, hvis De bemærker symptomer på infektion eller andre symptomer, såsom muskelsvaghed, svaghed begyndende i hænder og fødder, og som bevæger sig op igennem kroppen, hjertebanken, rysten eller hyperaktivitet.
English: What you need to know before you take SUSTIVA Do not take SUSTIVA if you are allergic to efavirenz or any of the other ingredients of this medicine (listed in section 6).
Danish: Det skal De vide, før De begynder at tage SUSTIVA Tag ikke SUSTIVA: hvis De er allergisk over for efavirenz eller et af de øvrige indholdsstoffer i Sustiva (angivet i punkt 6)Sustiva.
English: < 50 copies/ml (95% C.I.
Danish: < 50 kopier/ml (95% C.I.
English: At baseline, median plasma HIV-1 RNA was 4.8 log10 copies/mL, median CD4+ cell count was 367 cells/mm3, and median CD4+ percentage was 18%.
Danish: Ved baseline var det mediane plasma hiv-RNA 4,8 log10-kopier/ml, median-CD4+ celletal var 367 celler/mm3, og median-CD4+ procent var 18%.
English: Refer to the prescribing information for sofosbuvir/velpatasvir for more information.
Danish: Se ordineringsoplysningerne for sofosbuvir/velpatasvir for yderligere information.
English: PHARMACEUTICAL FORM Film-coated tablet
Danish: Filmovertrukne tabletter
English: SUSTIVA has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease inhibitor (PI) containing regimens.
Danish: SUSTIVA er ikke tilstrækkeligt undersøgt hos patienter med fremskreden hiv-sygdom, det vil sige patienter med CD4 tal < 50 celler/mm
English: CD4+ cell count was 755 cells/mm3, and median CD4+ percentage was 30%.
Danish: 755 celler/mm3 , og median-CD4+ procent var 30%.
English: Velpatasvir/ sofosbuvir/ voxilaprevir
Danish: Velpatasvir/sofosbuvir/voxilaprev ir
English: Study PACTG 1021 was an open-label study to evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of SUSTIVA in combination with didanosine and emtricitabine in paediatric patients who were antiretroviral therapy naive.
Danish: Studie PACTG 1021 var et ikke-blindet studie til evaluering af SUSTIVAs farmakokinetik, sikkerhed, tolerabilitet og antivirale aktivitet i kombination med didanosin og emtricitabin hos antiretroviralnaive pædiatriske patienter.
English: *compared to 200 mg twice daily alone ** compared to 600 mg once daily alone (competitive inhibition of oxidative metabolism)
Danish: AUC: ↑ 17% (↑ 6 til ↑ 29)** Cmax: ↔** *sammenlignet med 200 mg alene to gange dagligt **sammenlignet med 600 mg alene én gang dagligt (kompetitiv hæmning af oxidativ metabolisme)
English: Antimalarials
Danish: Malariamidler
English: Efavirenz is contraindicated in patients with severe hepatic impairment (see sections 4.3 and 5.2) and not recommended in patients with moderate hepatic impairment because of insufficient data to determine whether dose adjustment is necessary.
Danish: 4.3 og 5.2) og bør ikke gives til patienter med moderat leverinsufficiens, da data er utilstrækkelige til at afgøre, om dosisjustering er nødvendig.
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.
Danish: Plasmakoncentrationen for phenytoin, phenobarbital og andre antikonvulsiva, som er substrater for CYP-isoenzymer, kan eventuelt falde eller stige, når disse administreres samtidigt med efavirenz.
English: Efficacy results for studies ACTG 364 and 020 are found in Table 4.
Danish: Effektresultater for undersøgelserne ACTG 364 og 020 kan ses i tabel 4.
English: The combination was generally well tolerated.
Danish: Denne kombination bør anvendes med forsigtighed.
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%.
Danish: Ved baseline var det mediane plasma-hiv-RNA 5,88 log10-kopier/ml, median-CD4+ celletal var 1.144 celler/mm3, og median-CD4+ procent var 25%.
English: Famotidine/Efavirenz (40 mg single dose/400 mg single dose)
Danish: Famotidin/efavirenz (40 mg enkeltdosis/400 mg enkeltdosis)
English: How to take SUSTIVA Always take this medicine exactly as your doctor or pharmacist has told you.
Danish: Sådan skal De tage SUSTIVA Tag altid lægemidlet nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: Lopinavir/ritonavir soft capsules or oral solution/Efavirenz
Danish: Lopinavir/ritonavir/bløde kapsler eller oral opløsning/efavirenz
English: Efavirenz levels may increase on stopping St. John's wort and the dose of efavirenz may need adjusting.
Danish: Koncentrationen af efavirenz kan stige, når perikon seponeres, og det kan være nødvendigt at justere dosis.
English: The other ingredients of the powder contained in the hard capsule are: sodium laurilsulfate, lactose monohydrate, magnesium stearate and sodium starch glycolate.
Danish: Ovrige indholdsstoffer i pulveret i den hårde kapsel: Natriumlaurilsulfat, lactosemonohydrat, magnesiumstearat og natriumstivelsesglycolat.
English: Efavirenz: AUC: ↑ 44%
Danish: AUC: ↑ 44%
English: Efficacy results for studies ACTG 364 and 020 are found in Table 3.
Danish: Effektresultater for undersøgelserne ACTG 364 og 020 kan ses i tabel 3.
English: a NC = F, noncompleter = failure.
Danish: IDV + ZDV + 3TC a NC = F, non-completer = failure b C.I., konfidensinterval.
English: Your doctor may give you a different anticonvulsant.
Danish: Lægen vil måske give Dem en anden medicin mod krampeanfald.
English: Tests may show: increased liver enzymes in the blood increased trigycerides (fatty acids) in the blood
Danish: Forhøjet indhold af triglycerider (fedtsyrer) i blodet
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.
Danish: Dette skyldes perikons induktion af lægemiddelmetaboliserende enzymer og/eller transportproteiner.
English: A reliable method of barrier contraception must be used in addition to hormonal contraceptives (see section 4.6).
Danish: Der skal anvendes en pålidelig kontraceptiv barrieremetode som supplement til hormonelle kontraceptiva (se pkt.
English: Check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er noget, De er i tvivl om.
English: Refer to the prescribing information for velpatasvir/sofosbuvir/ voxilaprevir for more information.
Danish: Se ordineringsoplysningerne for velpatasvir/sofosbuvir/voxil aprevir for yderligere information.
English: Body Weight efavirenz
Danish: Legemsvægt efavirenz
English: Atovaquone and proguanil hydrochloride/Efavirenz (250/100 mg single dose/600 mg once daily)
Danish: Atovaquon og proguanil hydrochlorid/efavirenz (250/100 mg enkeltdosis/600 mg én gang dagligt)
English: Efavirenz must not be administered concurrently with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, or ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine), since inhibition of their metabolism may lead to serious, lifethreatening events (see section 4.3).
Danish: Efavirenz må ikke administreres sammen med terfenadin, astemizol, cisaprid, midazolam, triazolam, pimozid, bepridil eller sekalealkaloider (fx ergotamin, dihydroergotamin, ergonovin og methylergonovin), da hæmning af disses metabolisme kan føre til alvorlige livstruende hændelser (se pkt.
English: CCR5 antagonist Maraviroc/Efavirenz (100 mg twice daily/600 mg once daily)
Danish: CCR5-antagonist Maraviroc/efavirenz (100 mg to gange dagligt/600 mg én gang dagligt)
English: Coadministration of glecaprevir/pibrentasvir with efavirenz is not recommended.
Danish: Samtidig administration af glecaprevir/pibrentasvir med efavirenz anbefales ikke.
English: Bottle: 30 film-coated tablets
Danish: HDPE-beholder: 30 filmovertrukne tabletter
English: Immune system disorders uncommon hypersensitivity
Danish: Immunsystemet Ikke almindelig
English: If you have any further questions, ask your doctor, pharmacist or nurse.
Danish: Er De i tvivl så spørg lægen eller på apoteket.
English: Dose adjustment of simvastatin may be required (refer to the Summary of Product Characteristics for simvastatin).
Danish: Dosisjustering af simvastatin kan være påkrævet (se SPC for simvastatin).
English: Cmin: ↑ 13% (↑ 1 to ↑ 26) (CYP3A4 induction) The increase in efavirenz pharmacokinetic parameters is not considered clinically significant.
Danish: AUC: ↑ 11% (↑ 5 til ↑ 18) Cmax: ↑ 16% (↑ 6 til ↑ 26) Cmin: ↑ 13% (↑ 1 til ↑ 26) (CYP3A4-induktion) Stigningen i efavirenz' farmakokinetiske parametre anses ikke for at være klinisk signifikant.
English: Rare (affects 1 to 10 users in 10,000) itchy rash caused by a reaction to sunlight liver failure, in some cases leading to death or liver transplant, has occurred with efavirenz.
Danish: Sjældne (berører 1 til 10 ud af 10.000 brugere) Kløende udslæt som en reaktion på sollys
English: ACID REDUCING AGENTS Aluminium hydroxide-magnesium hydroxide-simethicone antacid/Efavirenz (30 ml single dose/400 mg single dose)
Danish: Aluminiumhydroxidmagnesiumhydroxid-simeticon antacida/efavirenz (30 ml enkeltdosis/400 mg enkeltdosis)
English: What SUSTIVA looks like and contents of the pack SUSTIVA 50 mg hard capsules are supplied in bottles of 30 capsules.
Danish: SUSTIVAS udseende og pakningsstørrelser SUSTIVA 50 mg hårde kapsler fås i beholdere med 30 kapsler.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé; pkt.
English: Protease inhibitor : Elbasvir/ grazoprevir
Danish: Proteasehæmmer: Elbasvir/grazoprevir
English: What SUSTIVA looks like and contents of the pack SUSTIVA 100 mg hard capsules are supplied in bottles of 30 capsules.
Danish: SUSTIVAS udseende og pakningsstørrelser SUSTIVA 100 mg hårde kapsler fås i beholdere med 30 kapsler.
English: OUTER CARTON AND LABEL TEXT FOR BOTTLE PACK
Danish: YDRE PAKNING OG ETIKETTEKST PÅ BEHOLDER TEKST TIL YDRE PAKNING TIL BLISTERPAKNING
English: If efavirenz is coadministered with voriconazole, the voriconazole maintenance dose must be increased to 400 mg every 12 hours and the efavirenz dose must be reduced by 50%, i.e., to 300 mg once daily.
Danish: Hvis efavirenz administreres sammen med voriconazol, skal vedligeholdelsesdosis af voriconazol øges til 400 mg hver 12. time, og dosis af efavirenz skal reduceres med 50%, dvs. til 300 mg én gang dagligt.
English: SUSTIVA 50 mg hard capsules
Danish: SUSTIVA 50 mg hårde kapsler
English: In 35 patients receiving efavirenz 600 mg once daily, steady state Cmax was 12.9 ± 3.7 μM (29%) [mean ± S.D. (% C.V.)], steady state Cmin was 5.6 ± 3.2 μM (57%), and AUC was 184 ± 73 μM·h (40%).
Danish: Hos 35 patienter, der fik efavirenz 600 mg 1 gang dagligt var gennemsnitlige steady-state Cmax 12,9 ± 3,7 μM (29%) [gennemsnit ± S.D. (% C.V.
English: When efavirenz is coadministered with voriconazole, the voriconazole maintenance dose must be increased to 400 mg twice daily and the efavirenz dose must be reduced by 50%, i.e., to 300 mg once daily.
Danish: Når efavirenz administreres sammen med voriconazol, bør vedligeholdelsesdosis for voriconazol øges til 400 mg to gange dagligt, og efavirenzdosis skal reduceres med 50%, dvs. 300 mg én gang dagligt.
English: Your doctor will check your cholesterol levels and will consider changing the dose of your statin, if needed.
Danish: Lægen vil kontrollere Deres kolesterol i blodet og måske ændre statindosis.
English: SUSTIVA is recommended to be taken on an empty stomach preferably at bedtime.
Danish: Det anbefales at tage SUSTIVA på tom mave, helst ved sengetid.
English: NOREPINEPHRINE AND DOPAMINE REUPTAKE INHIBITOR Bupropion/Efavirenz [150 mg single dose (sustained release)/600 mg once daily]
Danish: Noradrenalin og dopamin genoptagelseshæmmer Bupropion/efavirenz [150 mg enkeltdosis (som depot)/600 mg én gang dagligt]
English: Plasma concentrations and effects of warfarin or acenocoumarol are potentially increased or decreased by efavirenz.
Danish: Efavirenz kan medføre stigning eller fald i warfarins eller acenocoumarols plasmakoncentration og virkning.
English: QTc prolongation has been observed with the use of efavirenz (see sections 4.5 and 5.1).
Danish: Der er set forlænget QTc-interval ved anvendelse af efavirenz (se pkt.
English: Concomitant administration of glecaprevir/pibrentasvir with efavirenz may significantly decrease plasma concentrations of glecaprevir and pibrentasvir, leading to reduced therapeutic effect.
Danish: Samtidig administration af glecaprevir/pibrentasvir med efavirenz kan medføre signifikante fald i plasmakoncentrationerne af glecaprevir og pibrentasvir og medføre nedsat terapeutisk effekt.
English: Selective Serotonin Reuptake Inhibitors (SSRIs) Sertraline/Efavirenz (50 mg once daily/600 mg once daily)
Danish: Selektive serotonin genoptagelseshæmmere (SSRIer) Sertralin/efavirenz (50 mg én gang dagligt/600 mg én gang dagligt)
English: LIPID LOWERING MEDICINAL PRODUCTS HMG Co-A Reductase Inhibitors Atorvastatin/Efavirenz (10 mg once daily/600 mg once daily)
Danish: LIPIDSÆNKENDE LÆGEMIDLER HMG Co-A reduktasehæmmere Atorvastatin/efavirenz (10 mg én gang dagligt/600 mg én gang dagligt)
English: Hepatitis C antivirals Boceprevir/Efavirenz (800 mg 3 times daily/600 mg once daily)
Danish: Lægemidler mod hepatitis C-virus Boceprevir/efavirenz (800 mg 3 gange dagligt/600 mg en gang dagligt)
English: The administration of efavirenz with food may increase efavirenz exposure and may lead to an increase in the frequency of adverse reactions (see section 4.4).
Danish: Administration af efavirenz sammen med mad kan øge efavirenzeksponeringen og kan føre til øget hyppighed af bivirkninger (se pkt.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Bristol-Myers Squibb Pharma EEIG
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Bristol-Myers Squibb Pharma EEIG
English: one 100 mg capsule
Danish: en 100 mg kapsel
English: SUSTIVA 200 mg hard capsules
Danish: SUSTIVA 200 mg hårde kapsler
English: three 100 mg capsules + one 50 mg capsule
Danish: tre 100 mg kapsler + en 50 mg kapsel
English: Dose adjustment of pravastatin may be required (refer to the Summary of Product Characteristics for pravastatin).
Danish: Dosisjustering af pravastatin kan være påkrævet (se SPC for pravastatin).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/110/001-004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/99/110/001 - 004
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.
Danish: SUSTIVA 200 mg hårde kapsler må indtages af børn og unge, der er 3 måneder og ældre, der vejer mindst 3,5 kg og som er i stand til at sluge kapslerne.
English: Each hard capsule contains 114.0 mg of lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver hård kapsel indeholder 114,0 mg lactose (i form af monohydrat).
English: Protease inhibitors (PI) Atazanavir/ ritonavir/Efavirenz (400 mg once daily/100 mg once daily/600 mg once daily, all administered with food)
Danish: ANTI-INFEKTIVA Lægemidler mod hiv Proteasehæmmere (PIer) Atazanavir/ritonavir/efavirenz (400 mg én gang dagligt/100 mg én gang dagligt/600 mg én gang dagligt, alle administreret sammen med mad)
English: Atazanavir/ritonavir/Efavirenz (400 mg once daily/200 mg once daily/600 mg once daily, all administered with food)
Danish: Atazanavir/ritonavir/efavirenz (400 mg én gang dagligt/200 mg én gang dagligt/600 mg én gang dagligt, alle administreret sammen med mad)
English: How to take SUSTIVA
Danish: Sådan skal De tage SUSTIVA
English: Telaprevir/Efavirenz (1,125 mg q8h/600 mg once daily)
Danish: Telaprevir/efavirenz (1,125 mg q8h/600 mg en gang dagligt)
English: The tablets are printed with inks containing hypromellose (E464), propylene glycol, cochineal carminic acid (E120), indigo carmine (E132) and titanium dioxide (E171).
Danish: Tabletterne er præget med prægeblæk indeholdende hypromellose (E464), propylenglycol, cochenillecarminsyre (E120), indigocarmin (E132) og titandioxid (E171).
English: The median increase from baseline in CD4+ count at 48 weeks of therapy was 128 cells/mm3 and the median increase in CD4+ percentage was 5%.
Danish: Den mediane stigning i CD4+ tal ved uge 48 fra baseline var 128 celler/mm3, og den mediane stigning i CD4+ procent var 5%.
English: Nervous system symptoms usually begin soon after therapy onset and generally resolve after the first 2 - 4 weeks.
Danish: Symptomer fra nervesystemet starter sædvanligvis hurtigt efter initiering af behandling og forsvinder generelt efter de første 2-4 uger.
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.
Danish: SUSTIVA 50 mg hårde kapsler må indtages af børn og unge, der er 3 måneder og ældre, der vejer mindst 3,5 kg, og som er i stand til at sluge kapslerne.
English: Convulsions have been observed in adult and paediatric patients receiving efavirenz, generally in the presence of known medical history of seizures.
Danish: Der er set krampeanfald hos voksne og pædiatriske patienter i efavirenzbehandling, disse patienter havde sædvanligvis krampeanfald i anamnesen.
English: Eye disorders uncommon vision blurred
Danish: Øjne Ikke almindelig
English: How to store SUSTIVA
Danish: Opbevaring af SUSTIVA
English: Caution must be taken in any patient with a history of seizures.
Danish: Der bør udvises forsigtighed hos patienter med krampeanfald i anamnesen.
English: Seizures
Danish: Udslæt
English: Coadministration of sofosbuvir/velpatasvir with efavirenz is not recommended.
Danish: Samtidig administration af sofosbuvir/velpatasvir med efavirenz anbefales ikke.
English: Your doctor may need to consider giving you a different anticonvulsant.
Danish: Lægen vil måske overveje at give Dem et andet lægemiddel mod krampeanfald.
English: SUSTIVA 100 mg hard capsules
Danish: SUSTIVA 100 mg hårde kapsler
English: Clarithromycin/Efavirenz (500 mg q12h/400 mg once daily)
Danish: Clarithromycin/efavirenz 500 mg q12h/400 mg én gang dagligt)
English: one 200 mg capsule
Danish: en 200 mg kapsel
English: Ethinyloestradiol: AUC: ↔
Danish: Ethinylestradiol:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/110/008 - bottle
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/99/110/008 - HDPE-beholder
English: Printing ink: Cochineal carminic acid (E120), Indigo carmine (E132), Titanium dioxide (E171)
Danish: Prægeblæk: Cochenillecarminsyre (E120), Indigocarmin (E132), Titandioxid (E171).
English: Each hard capsule contains 28.5 mg of lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver hård kapsel indeholder 28,5 mg lactose (i form af monohydrat).