natgillin/translations-raw huggingface dataset:
Patienter med leverproblemer (herunder hepatitis B eller C) kan have forhøjet risiko for leverskade, når de får Sustiva.
Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking Sustiva.
2/ 3 Hvorfor blev Sustiva godkendt?
2/ 3 Why has Sustiva been approved?
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Sustiva opvejer risiciene til antiretroviral kombinationsbehandling af hivsmittede voksne, unge og børn på tre år og derover.
The Committee for Medicinal Products for Human Use (CHMP) decided that Sustiva’ s benefits are greater than its risks in antiviral combination treatment of HIV-infected adults, adolescents and children three years of age and older.
Udvalget konstaterede, at Sustiva ikke er blevet tilstrækkelig undersøgt hos patienter med fremskreden sygdom (CD4- celletal under 50 celler/ mm3) eller patienter, hos hvem proteasehæmmere (en anden type antiviral medicin) ikke har virket.
The Committee noted that Sustiva has not been studied adequately in patients with advanced disease (CD4 cell counts below 50 cells/ mm3) or after treatment with protease inhibitors (another type of antiviral medicine) that was not working.
Der er dog ikke resultater, der tyder på, at proteasehæmmere ikke virker hos sådanne patienter.
The Committee also noted that there is little information on the benefits of treatment including a protease inhibitor in patients who have been treated with Sustiva in the past but which stopped working, although there is no evidence to suggest that protease inhibitors may not work in these patients.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Sustiva.
The Committee recommended that Sustiva be given marketing authorisation.
Andre oplysninger om Sustiva:
Other information about Sustiva:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Sustiva den 28. maj 1999.
The European Commission granted a marketing authorisation valid throughout the European Union for Sustiva on 28 May 1999.
Indehaveren af markedsføringstilladelsen er Bristol- Myers Squibb Pharma EEIG.
The marketing authorisation holder is Bristol-Myers Squibb Pharma EEIG.
Den fuldstændige EPAR for Sustiva findes her.
The full EPAR for Sustiva can be found here.
SUSTIVA er indiceret til antiviral kombinationsbehandling af humant immundefekt virus- 1 (HIV- 1) - 1- inficerede voksne, unge og børn fra 3 år og opefter.
SUSTIVA is indicated in antiviral combination treatment of human immunodeficiency virus-1 (HIV-1) infected adults, adolescents and children 3 years of age and older.
SUSTIVA er ikke tilstrækkeligt undersøgt hos patienter med fremskreden HIV- sygdom, det vil sige patienter med CD4 tal < 50 celler/ mm3, eller efter svigtende effekt af proteasehæmmerregimer (PI).
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.
Selvom der ikke er dokumenteret krydsresistens mellem efavirenz og PI´ere, er der i øjeblikket ikke tilstrækkelige data med hensyn til effekten af efterfølgende brug af PI baseret kombinationsbehandling efter svigtende effekt af regimer, der inkluderer SUSTIVA.
Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI based combination therapy after failure of regimens containing SUSTIVA.
4. 2 Dosering og indgivelssmåde
4.2 Posology and method of administration
4. 5).
SUSTIVA must be given in combination with other antiretroviral medicines (see section 4.5).
Det anbefales, at SUSTIVA tages på tom mave.
It is recommended that SUSTIVA be taken on an empty stomach.
4. 4 og 5. 2).
The increased efavirenz concentrations observed following administration of SUSTIVA with food may lead to an increase in frequency of adverse reactions (see sections 4.4. and 5.2).
4. 5) er 600 mg oralt 1 gang dagligt.
Adults: the recommended dosage of SUSTIVA in combination with nucleoside analogue reverse transcriptase inhibitors (NRTIs) with or without a PI (see section 4.5) is 600 mg orally, once daily.
Den anbefalede dosis af SUSTIVA i kombination med en PI´er og/ eller NRTI´ere til patienter i alderen 3 - 17 år er beskrevet i tabel 1.
Paediatric patients (3 to 17 years): the recommended dose of SUSTIVA in combination with a PI and/ or NRTIs for patients between 3 and 17 years of age is described in Table 1.
SUSTIVA bør ikke
SUSTIVA hard capsules must only be administered to children who are able to reliably swallow hard capsules.
5. 1 og 5. 2).
2 SUSTIVA is not recommended for use in children below the age of 3 years or weighing less than 13 kg due to a lack of data on safety and efficacy in that age group (see sections 5.1 and 5.2).
SUSTIVA perorale løsning er den foretrukne sammensætning, for børn og unge, der er mindst tre år gamle og mindst vejer 13 kg, og der ikke med sikkerhed kan sluge hårde kapsler.
Alternative method of administration: for children at least 3 years old and weighing at least 13 kg and adults who cannot reliably swallow hard capsules, SUSTIVA oral solution is the preferred formulation.
For børn der ikke kan tåle peroral løsning, kan man overveje indgivelse af kapslens indhold sammen med en lille mængde føde (fx en til to tsk.).
Administration of the capsule contents with a small amount (1-2 teaspoons) of food may be considered for patients who cannot tolerate the oral solution.
I en smagsprøve hos sunde voksne personer, hvor man gav efavirenz blandet i æblemost, druemarmelade, yoghurt eller modermælkserstatning, fik marmelade den højeste karakter for bedste smag.
In a palatability study in healthy adults of efavirenz mixed with applesauce, grape jelly, yogurt, or infant formula, grape jelly received the highest rating of good overall taste.
Patienter og plejere skal have besked om at åbne kapslen forsigtigt, for at undgå spild eller spredning af kapslens indhold ud i luften.
Patients and caregivers must be instructed to open the capsule carefully to avoid spillage or dispersion of the capsule contents into the air.
Det anbefales, at man holder kapslen lodret med dækken vendt opad, mens man trækker låget væk fra skærven på kapslen og blander kapslens indhold med føden i en lille beholder.
It is recommended to hold the capsule vertically with the cap facing up and to pull the cap away from the body of the capsule, and to mix the capsule contents with food in a small container.
Blandingen bør gives så hurtigt som muligt, dog ikke mere end 30 min. efter opblandingen.
The mixture should be administered as soon as possible, but no more than 30 minutes after mixing.
Efter indgivelse af efavirenz- blandingen, er man nødt til at blande yderligere en lille mængde (ca. to tsk.) føde i den tomme beholder til blanding, der røres om for at finfordele resten af medicinen og gives til patienten.
After administration of the efavirenz-food mixture, an additional small amount (approximately 2 teaspoons) of food must be added to the empty mixing container, stirred to disperse any remaining residue of the medicinal product, and administered to the patient.
Der bør ikke indtages ekstra føde op til to (2) timer efter indgivelse af efavirenz.
No additional food should be consumed for up to 2 hours after administration of efavirenz.
Der er begrænset sikkerheds - og tolerancedata ved indgivelse af kapslens indhold til børn.
There are limited safety and tolerability data for administration of the capsule contents in paediatric patients.
Tabel 1 Pædiatrisk dosistil indgivelse én gang daglig *.
Table 1 Paediatric dose to be administered once daily*
SUSTIVA Dosis (mg) 200 250 300 350 400 600
SUSTIVA Dose (mg) 200 250 300 350 400 600
5. 2.
*For information on the bioavailability of the capsule contents mixed with food vehicles, see section 5.2.
Dosisjustering:
Dosage adjustment:
Hvis SUSTIVA administreres sammen med voriconazol, bør voriconazols vedligeholdelsesdosis øges til 400 mg hver 12. time, og SUSTIVAs dosis bør reduceres med 50%, dvs. til 300 mg en gang dagligt.
If SUSTIVA is coadministered with voriconazole, the voriconazole maintenance dose must be increased to 400 mg every 12 hours and the SUSTIVA dose must be reduced by 50%, i. e., to 300 mg once daily.
4. 5).
If SUSTIVA is coadministered with rifampicin, an increase in the dose of SUSTIVA to 800 mg/ day may be considered (see section 4.5).
4. 5).
3 Efavirenz must not be administered concurrently with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, or ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) because competition for CYP3A4 by efavirenz could result in inhibition of metabolism and create the potential for serious and/ or life-threatening undesirable effects [for example, cardiac arrhythmias, prolonged sedation or respiratory depression] (see section 4.5).
Som med alle andre non- nukleosid reverse transkriptasehæmmere (NNRTI´ere), forekommer der hurtigt resistent virus, når efavirenz administreres som monoterapi.
As with all other non-nucleoside reverse transcriptase inhibitors (NNRTIs), resistant virus emerges rapidly when efavirenz is administered as monotherapy.
Efavirenz og den faste kombinationstablet indeholdende efavirenz, emtricitabin og tenofovirdisoproxilfumarat, bør ikke administreres samtidigt.
Co-administration of efavirenz with the fixed combination tablet containing efavirenz, emtricitabine, and tenofovir disoproxil fumarate is not recommended.
Ved ordinering af medicin til brug sammen med SUSTIVA, bør læger konsultere det pågældende produktresumé.
When prescribing medicinal products concomitantly with SUSTIVA, physicians should refer to the corresponding Summary of Product Characteristics.
Patienter, som seponerede behandling med andre NNRTI´ere på grund af udslæt, kan have højere risiko for at udvikle udslæt under behandling med efavirenz.
Patients who discontinued treatment with other NNRTIs due to rash may be at higher risk of developing rash during treatment with efavirenz.
Patienterne bør rådes til straks at kontakte deres læge, hvis de oplever symptomer såsom svær depression, psykose eller selvmordstanker, med henblik på vurdering af, om symptomerne er relaterede til brugen af efavirenz,
Patients should be advised that if they experience symptoms such as severe depression, psychosis or suicidal ideation, they should contact their doctor
4. 8).
4 immediately to assess the possibility that the symptoms may be related to the use of efavirenz, and if so, to determine whether the risks of continued therapy outweigh the benefits (see section 4.8).
5. 2) og kan føre til øget bivirkningshyppighed (se pkt.
Effect of food: the administration of SUSTIVA with food may increase efavirenz exposure (see section 5.2) and may lead to an increase in the frequency of adverse reactions (see section 4.8).
Det anbefales, at SUSTIVA tages på tom mave, helst ved sengetid.
It is recommended that SUSTIVA be taken on an empty stomach, preferably at bedtime.
Det er blevet antaget, at der er en forbindelse mellem visceral lipomatose og PI´ere samt lipoatrofi og NRTI´ere.
A connection between visceral lipomatosis and PIs and lipoatrophy and NRTIs has been hypothesised.
5 Sikkerhed og effekt hos patienter med underliggende signifikant leversygdom er ikke fastlagt.
The safety and efficacy of efavirenz has not been established in patients with significant underlying liver disorders.
Efavirenz er kontraindiceret til patienter med svært nedsat leverfunktion (se pkt.
Efavirenz is contraindicated in patients with severe hepatic impairment (see
4. 3).
5 section 4.3).
Patienter med eksisterende leverdysfunktion, inkl. kronisk aktiv hepatitis har øget frekvens af leverfunktionsabnormaliteter under antiretroviral kombinations - behandling og bør monitoreres i henhold til gældende praksis.
Patients with pre- existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
4. 2).
Renal insufficiency: the pharmacokinetics of efavirenz have not been studied in patients with renal insufficiency; however, less than 1% of an efavirenz dose is excreted unchanged in the urine, so the impact of renal impairment on efavirenz elimination should be minimal (see section 4.2).
Patienter med sjældne, arvelige sygdomme som galactoseintolerance, Lapp lactasemangel eller glucose/ galactose malabsorptionssyndrom bør ikke tage dette lægemiddel.
Lactose: patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
4. 3).
Contraindications of concomitant use 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, life-threatening events (see section 4.3).
Dette skyldes perikons induktion af lægemiddelmetaboliserende enzymer og/ eller transportproteiner.
John’ s wort due to induction of drug metabolising enzymes and/ or transport proteins by St.
Hvis patienten allerede tager perikon, skal dette seponeres og de virale niveauer og evt. efavirenzkoncentrationen kontrolleres.
John’ s wort, check viral levels and if possible efavirenz levels.
Koncentrationen af efavirenz kan stige, når perikon seponeres, og det kan være nødvendigt at justere dosis.
John’ s wort and the dose of efavirenz may need adjusting.
Perikons induktionsevne kan vare ved i mindst 2 uger efter seponering af behandlingen (se pkt.
John’ s wort may persist for at least 2 weeks after cessation of treatment.
Andre interaktioner Interaktion mellem efavirenz og proteasehæmmere, andre antiretrovirale lægemidler end proteasehæmmere og andre ikke- antiretrovirale lægemidler ses i tabel 2 nedenfor (stigning vises som
Other interactions Interactions between efavirenz and protease inhibitors, antiretroviral agents other than protease inhibitors and other non-antiretroviral medicinal products are listed in Table 2 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, and once every 8 or 12 hours as “ q8h” or “ q12h”).
Tabel 2:
6 Table 2:
Lægemidler i henhold til terapeutisk
Medicinal product by
område (dosis)
therapeutic areas (dose)
Hvis samtidig administration af atazanavir og et NNRTI er nødvendig, bør det overvejes at øge dosis for både atazanavir og ritonavir til henholdsvis 400 mg og 200 mg sammen med
If the co- administration of atazanavir with an NNRTI is required, an increase in the dose of both
efavirenz med tæt klinisk monitorering.
atazanavir and ritonavir to 400 mg and 200 mg, respectively, in combination with efavirenz could be considered with close clinical monitoring.
AUC: ↓ 13% Cmin: ↓ 31% (CYP3A4- induktion)
AUC: ↓ 13% Cmin: ↓ 31% (CYP3A4 induction)
Lignende fund forventes med den godkendte darunavir/ ritonavir 600/ 100 mg to
Similar findings are expected with the approved
gange dagligt.
darunavir/ ritonavir 600/ 100 mg twice daily dose.
Anbefales ikke, da eksponering over for begge PI' er forventes at være betydeligt nedsat.
Not recommended as the exposure to both PIs is expected to be significantly decreased.
7 Lægemidler i henhold til terapeutisk
Medicinal product by
Indinavir/ efavirenz (800 mg q8h/ 200 mg én gang dagligt)
Indinavir/ ritonavir/ Efavirenz (800 mg twice daily/ 100 mg twice daily/ 600 mg once daily)
AUC: ↓ 31% (↓ 8 til ↓ 47) Cmin: ↓ 40% Der sås en lignende reduktion i indinavireksponering, når indinavir 1. 000 mg q8h blev givet sammen med efavirenz 600 mg dagligt.
AUC: ↓ 25% (↓ 16 to ↓ 32)b Cmax: ↓ 17% (↓ 6 to ↓ 26)b Cmin: ↓ 50% (↓ 40 to ↓ 59)b Efavirenz:
Ingen klinisk signifikant farmakokinetisk interaktion.
No clinically significant pharmacokinetic interaction The geometric mean Cmin for indinavir (0.33 mg/ l) when given with ritonavir
Geometrisk gennemsnitligt Cmin for indinavir (0, 33 mg/ l), når det blev givet sammen med ritonavir og efavirenz, var højere end det gennemsnitlige historiske Cmin (0, 15 mg/ l), når indinavir blev givet alene ved 800 mg q8h.
and efavirenz was higher than the mean historical Cmin (0.15 mg/ l) when indinavir was given alone at 800 mg q8h.
Sammen med efavirenz bør en øgning af dosis for lopinavir / ritonavir blød kapsel eller oral opløsning på 33%
With efavirenz, an increase of the lopinavir/ ritonavir soft capsule or oral solution doses
Lopinavir/ ritonavirtabletter/ efavirenz (400/ 100 mg to gange dagligt/ 600 mg én gang dagligt)
Lopinavir/ ritonavir tablets/ Efavirenz
Lopinavirkoncentrationer: ↓ 30- 40% Lopinavirkoncentrationer:
Lopinavir concentrations: ↓ 30-40%
overvejes (4 kapsler/ ~ 6, 5 ml to gange dagligt i stedet for 3 kapsler/ 5 ml to gange dagligt).
instead of 3 capsules/ 5 ml twice daily).
Forsigtighed tilrådes, da denne
Caution is warranted
dosisjustering kan være utilstrækkelig hos nogle patienter.
since this dosage adjustment might be insufficient in some patients.
Dosering af lopinavir/ ritonavirtabletter bør øges til 500/ 125 mg to gange dagligt, når de administreres sammen med efavirenz 600 mg én gang dagligt.
The dosage of lopinavir/ ritonavir tablets should be increased to 500/ 125 mg twice daily when co-administered with efavirenz 600 mg once daily.
8 Lægemidler i henhold til terapeutisk
Medicinal product by
AUC morgen: ↑ 18% (↑ 6 til ↑ 33) AUC aften: ↔ Cmax morgen: ↑ 24% (↑ 12 til ↑ 38) Cmax aften: ↔ Cmin morgen: ↑ 42% (↑ 9 til ↑ 86) b Cmin aften: ↑ 24% (↑ 3 til ↑ 50) b Efavirenz:
Morning AUC: ↑ 18% (↑ 6 to ↑ 33) Evening AUC: ↔ Morning Cmax: ↑ 24% (↑ 12 to ↑ 38) Evening Cmax: ↔ Morning Cmin: ↑ 42% (↑ 9 to ↑ 86) b Evening Cmin: ↑ 24% (↑ 3 to ↑ 50) b Efavirenz:
Når efavirenz blev givet sammen med ritonavir 500 mg eller 600 mg to gange dagligt, var kombinationen ikke veltolereret (bl. a. forekom svimmelhed, kvalme, paræstesier og forhøjede leverenzymer).
AUC: ↑ 21% (↑ 10 to ↑ 34) Cmax: ↑ 14% (↑ 4 to ↑ 26) Cmin: ↑ 25% (↑ 7 to ↑ 46) b (inhibition of CYP-mediated oxidative metabolism) When efavirenz was given with ritonavir 500 mg or 600 mg twice daily, the combination was not well tolerated (for example, dizziness, nausea, paraesthesia and elevated liver enzymes occurred).
9 Lægemidler i henhold til terapeutisk
NRTIs/ Efavirenz
Indvirkning på
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.
Anbefaling vedrørende samtidig
No dosage adjustment is necessary for either medicinal product.
område (dosis)
NNRTIs/ Efavirenz
lægemiddelkoncentrationen, gennemsnitlig ændring (%) i AUC, Cmax, Cmin med konfidensintervaller hvis muligta (mekanisme)
Interaction not studied.
administration med efavirenz
Since use of two NNRTIs proved not beneficial in terms of efficacy and safety, co-administration of efavirenz
NRTIer og NNRTIer NRTIer/ efavirenz
Medicinal product by
Der er ikke udført specifikke interaktionsundersøgelser med efavirenz og NRTIer ud over lamivudin, zidovudin og tenofovirdisoproxilfumarat.
Effects on drug levels
Dosisjustering er ikke nødvendig for disse lægemidler.
Recommendation concerning
NNRTIer/ efavirenz Antibiotika
therapeutic areas (dose)
Interaktion er ikke undersøgt.
Mean percent change in AUC, Cmax, Cmin with confidence intervals if availablea (mechanism)
Da anvendelse af to af NNRTIerne ikke viste sig at være gunstig med hensyn til effektivitet og sikkerhed, anbefales samtidig administration af efavirenz og en anden NNRTI ikke.
co-administration with efavirenz
Azithromycin/ efavirenz (600 mg enkeltdosis/ 400 mg én gang dagligt)
Antibiotics Azithromycin/ Efavirenz (600 mg single dose/ 400 mg once daily)
Andre makrolidantibiotika (fx erythromycin) / efavirenz Antimykobakterielle lægemidler
Other macrolide antibiotics (e. g. ,erythromycin)/ Efavirenz Antimycobacterials
Rifabutin/ efavirenz (300 mg én gang dagligt/ 600 mg én gang dagligt)
Rifabutin/ Efavirenz (300 mg once daily/ 600 mg once daily)
10 Lægemidler i henhold til terapeutisk
Medicinal product by
Itraconazol/ efavirenz (200 mg q12h/ 600 mg én gang dagligt)
Antifungals Itraconazole/ Efavirenz (200 mg q12h/ 600 mg once daily)
300 mg én gang dagligt.
When efavirenz is co- administered 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
Ketoconazol og andre imidazol - antimykotika
Ketoconazole and other imidazole antifungals
11 Lægemidler i henhold til terapeutisk
Medicinal product by
Aluminiumhydroxid - magnesiumhydroxid- simeticon antacida/ efavirenz (30 ml enkeltdosis/ 400 mg enkeltdosis) Famotidin/ efavirenz (40 mg enkeltdosis/ 400 mg enkeltdosis ANXIOLYTIKA
ACID REDUCING AGENTS Aluminium hydroxide-magnesium hydroxide-simethicone antacid/ Efavirenz (30 ml single dose/ 400 mg single dose) Famotidine/ Efavirenz (40 mg single dose/ 400 mg single dose) ANTIANXIETY AGENTS
Hverken aluminium - / magnesiumhydroxidantacida eller famotidin ændrede absorptionen af efavirenz.
Neither aluminium/ magnesium hydroxide antacids nor famotidine altered the absorption of efavirenz.
Lorazepam/ efavirenz (2 mg enkeltdoser/ 600 mg én gang dagligt) ANTIKONVULSIVA
Lorazepam/ Efavirenz (2 mg single dose/ 600 mg once daily) ANTICONVULSANTS
Carbamazepin/ efavirenz (400 mg én gang dagligt/ 600 mg én gang dagligt)
Carbamazepine/ Efavirenz (400 mg once daily/ 600 mg once daily)
Steady- state AUC, Cmax og Cmin for den aktive carbamazepinepoxid- metabolit forblev uændret.
CYP3A4 and CYP2B6 induction) The steady-state AUC, Cmax and Cmin of the active carbamazepine epoxide metabolite remained unchanged.
Plasmakoncentrationen for phenytoin, phenobarbital og andre antikonvulsiva, som er substrater for CYP450 - isoenzymer, kan eventuelt falde eller stige, når disse administreres samtidigt med efavirenz.
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 co- administered with efavirenz.
Når efavirenz administreres sammen med et antikonvulsivum, som er et substrat for CYP450- isoenzymer, bør regelmæssig monitorering af antikonvulsiva- koncentrationen foretages.
When efavirenz is co- administered with an anticonvulsant that is a substrate of CYP450 isoenzymes, periodic monitoring of anticonvulsant levels should be conducted.
12 Lægemidler i henhold til terapeutisk
Medicinal product by
Selektive serotonin genoptagelseshæmmere (SSRIer) Sertralin/ efavirenz (50 mg én gang dagligt/ 600 mg én gang dagligt)
ANTIDEPRESSANTS Selective Serotonin Reuptake Inhibitors (SSRIs) Sertraline/ Efavirenz (50 mg once daily/ 600 mg once daily)
Øgning af sertralindosis bør være under vejledning af klinisk respons.
Sertraline dose increases should be guided by clinical response.
Cetirizin/ efavirenz (10 mg enkeltdoser/ 600 mg én gang dagligt) KARDIOVASKULÆRE LÆGEMIDLER Kalciumkanalblokkere
Cetirizine/ Efavirenz (10 mg single dose/ 600 mg once daily) CARDIOVASCULAR AGENTS Calcium Channel Blockers
Diltiazem/ efavirenz (240 mg én gang dagligt/ 600 mg én gang dagligt)
Diltiazem/ Efavirenz (240 mg once daily/ 600 mg once daily)
Når efavirenz gives sammen med en kalciumkanalblokker, som er et substrat for CYP3A4 - enzymet, kan kalciumkanalblokkerens plasmakoncentration potentielt blive reduceret.
When efavirenz is co-administered with a calcium channel blocker that is a substrate of the CYP3A4 enzyme, there is a potential for reduction in the plasma
Dosisjustering af kalciumkanalblokkere bør foretages ud fra klinisk respons (se SPC for kalciumkanalblokkeren).
Dose adjustments of calcium channel blockers should be guided by clinical response (refer to the Summary of Product Characteristics for the
Atorvastatin/ efavirenz (10 mg én gang dagligt/ 600 mg én gang dagligt)
LIPID LOWERING MEDICINAL PRODUCTS HMG Co-A Reductase Inhibitors Atorvastatin/ Efavirenz (10 mg once daily/ 600 mg once daily)