natgillin/translations-raw huggingface dataset:
Behandlingsnaive darunavir/cobicistat 800/150 mg en gang dagligt N=295
Treatment-naïve darunavir/cobicistat 800/150 mg once daily N=295
Darunavir Mylan skal tages i kombination med en lav dosis af cobicistat eller ritonavir og andre antihiv-lægemidler.
Darunavir must be taken in combination with a low dose of cobicistat or ritonavir and other anti-HIV medicines.
Kombinationen af rifampicin og darunavir med lavdosis ritonavir er kontraindiceret (se pkt.
The combination of rifampicin and darunavir with concomitant low dose ritonavir is contraindicated (see section 4.3).
Opbevaring af Darunavir Mylan
How to store Darunavir Mylan
- Buprenorphin/naloxon (til behandling af opioidafhængighed) - Salmeterol (lægemiddel til behandling af astma) - Artemether/lumefantrin (et kombinationslægemiddel til behandling af malaria) - Dasatinib, everolimus, irinotecan, nilotinib, vinblastin, vincristin (til behandling af cancer) - Sildenafil, tadalafil, vardenafil (til behandling af rejsningsbesvær eller af en hjerte- og lungesygdom, der hedder pulmonal arteriel hypertension) - Glecaprevir/pibrentasvir, simeprevir (til behandling af en hepatitis C-infektion) - Fentanyl, oxycodon, tramadol (til behandling af smerter) - Fesoterodin, solifenacin (til behandling af sygdomme i urinvejene).
- Buprenorphine/naloxone (medicines to treat opioide dependence) - Salmeterol (medicine to treat asthma) - Artemether/lumefantrine (a combination medicine to treat malaria) - Dasatinib, everolimus, irinotecan, nilotinib, vinblastine, vincristine (to treat cancer) - Sildenafil, tadalafil, vardenafil (for erectile dysfunction or to treat a heart and lung disorder called pulmonary arterial hypertension) - Glecaprevir/pibrentasvir, simeprevir (to treat hepatitis C infection) - Fentanyl, oxycodone, tramadol (to treat pain) - Fesoterodine, solifenacin (to treat urologic disorders).
Med hiv-1-RNA (kopier/ml) ved baseline
With Baseline HIV-1 RNA (copies/ml)
Hver tablet indeholder 150 mg darunavir.
Each tablet contains 150 milligram of darunavir.
Tenofovirdisoproxil 245 mg x 1
Tenofovir disoproxil 245 mg once daily‡
HDPE-flaskepakke med polypropylenskruelåg indeholdende 60 og 100 tabletter.
HDPE bottle pack with a PP screw cap containing 60 and 100 tablets.
Gennemsnitlig CD4+ celletalsændring fra baseline (x 10
Otherc mean CD4+ cell count change from baseline (x 10
Dosis til børn fra 3 år og opefter med en legemsvægt mere end 40 kg, som ikke har taget antiretrovirale lægemidler før (barnets læge vil afgøre dette) - Den sædvanlige dosis darunavir er 800 mg (2 tabletter a 400 mg darunavir eller 1 tablet a
Dose for children 3 years of age and above, weighing more than 40 kilograms who have not taken antiretroviral medicines before (your child's doctor will determine this) - The usual dose of darunavir is 800 milligram (2 tablets containing 400 milligram of darunavir or
375 mg darunavir/50 mg ritonavir to gange dagligt
375 mg darunavir/50 mg ritonavir twice daily
Samtidig anvendelse af boostet darunavir og elbasvir/grazoprevir er kontraindiceret (se pkt.
Concomitant use of boosted darunavir and elbasvir/grazoprevir is contraindicated (see section 4.3).
Darunavir Mylan 150 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 150 mg darunavir.
Darunavir Mylan 150 mg film-coated tablets Each film-coated tablet contains 150 mg of darunavir.
Doser til voksne, som har taget antiretrovirale lægemidler før (din læge vil fastsætte dette) Dosis er enten: - 600 mg darunavir (2 tabletter der indeholder 300 mg darunavir eller 1 tablet der indeholder 600 mg darunavir) sammen med 100 mg ritonavir to gange dagligt.
Dose for adults who have taken antiretroviral medicines before (your doctor will determine this) The dose is either: - 600 milligram darunavir (2 tablets containing 300 milligram of darunavir or 1 tablet containing 600 milligram of darunavir) together with 100 milligram ritonavir twice daily.
For patienter, der får kombinationsbehandling med darunavir co-administreret med ritonavir, er det nødvendigt at reducere dosis af rifabutin med 75% af den sædvanlige dosis på 300 mg/dag (f.eks. rifabutin 150 mg hver anden dag) samt en skærpelse i overvågningen af rifabutin-relaterede bivirkninger.
A dosage reduction of rifabutin by 75% of the usual dose of 300 mg/day (i.e. rifabutin 150 mg once every other day) and increased monitoring for rifabutin related adverse events is warranted in patients receiving the combination with darunavir coadministered with ritonavir.
Darunavir Mylan indeholder natrium
Darunavir Mylan contains sodium
Anvisninger for børn fra 3 år og opefter med en legemsvægt på mindst 40 kg - Tag hver dag 800 mg darunavir (2 tabletter a 400 mg darunavir eller 1 tablet a 800 mg darunavir) om dagen og på samme tidspunkt.
Instructions for children 3 years of age and above, weighing more than 40 kilograms - Take 800 milligram darunavir (2 tablets containing 400 milligram of darunavir or 1 tablet containing 800 milligram of darunavir) at the same time, once a day, every day.
Denne dosis må ikke overstige den anbefalede dosis til voksne, som er 600 mg darunavir sammen med 100 mg ritonavir to gange om dagen eller 800 mg darunavir sammen med 100 mg ritonavir én gang om dagen.
This dose must not exceed the recommended adult dose, which is 600 milligram darunavir together with 100 milligram of ritonavir two times per day or 800 milligram darunavir together with 100 milligram ritonavir once a day.
(CYP3A og/eller CYP2D6-hæmning)
(CYP3A and/or CYP2D6 inhibition)
buprenorphin AUC  11% buprenorphin Cmin ↔ buprenorphin Cmax  8% norbuprenorphin AUC ↑ 46% norbuprenorphin Cmin ↑ 71% norbuprenorphin Cmax ↑ 36% naloxon AUC ↔ naloxon Cmin ND naloxon Cmax ↔
Buprenorphine/naloxone 8/2 mg-16/4 mg once daily buprenorphine AUC ↓ 11% buprenorphine Cmin ↔ buprenorphine Cmax ↓ 8% norbuprenorphine AUC ↑ 46% norbuprenorphine Cmin ↑ 71% norbuprenorphine Cmax ↑ 36% naloxone AUC ↔ naloxone Cmin ND naloxone Cmax ↔
Darunavir/ ritonavir 600/100 mg to gange dagligt n=131
Darunavir/ ritonavir 600/100 mg twice daily n=131
Darunavir Mylan 75 mg filmovertrukne tabletter
Darunavir Mylan 75 mg film-coated tablets
ELLER - 800 mg darunavir (2 tabletter der indeholder 400 mg darunavir eller 1 tablet der indeholder 800 mg darunavir) sammen med 100 mg ritonavir en gang dagligt.
OR - 800 milligram darunavir (2 tablets containing 400 milligram of darunavir or 1 tablet containing 800 milligram of darunavir) together with 100 milligram ritonavir once daily.
Darunavir Mylan anvendes til at behandle voksne og børn fra og med 3 år med en kropsvægt på mindst 40 kg, som erhiv-inficerede, og - som ikke har anvendt antiretrovirale lægemidler før.
Darunavir is used to treat adults and children 3 years of age and above, at least 40 kilograms body weight) who are infected by HIV and - who have not used antiretroviral medicines before.
# Der er gennemført studier med doser af darunavir, der var lavere end den anbefalede dosis, eller med et andet doseringsregime (se pkt.
# Studies have been performed at lower than recommended doses of darunavir or with a different dosing regimen (see section 4.2 Posology).
30 filmovertrukne tabletter 60 filmovertrukne tabletter 60 x 1 filmovertrukne tabletter
Blister carton 30 film-coated tablets 60 film-coated tablets 60 x 1 film-coated tablets
Koldformet PVC/Al/OPA-Al-blisterpakning, der indeholder 30 og 60 tabletter og 60 x 1 tabletter.
Cold form PVC/Al/OPA-Al blister pack containing 30 and 60 tablets and 60x1 tablets.
Farmakokinetiske resultater for total-darunavir efter administration af 800/150 mg darunavir/cobicistat en gang dagligt som del af et antiretroviralt regime i andet trimester af graviditeten, tredje trimester af graviditeten og post partum Farmakokinetik for total-darunavir (Gennemsnit ± SD)
Pharmacokinetic results of total darunavir after administration of darunavir/cobicistat 800/150 mg once daily as part of an antiretroviral regimen, during the second trimester of pregnancy, the third trimester of pregnancy, and postpartum
Dosis til voksne, som tidligere har fået antiretroviral medicin (din læge vil afgøre dette) Dosis er enten: - 800 mg darunavir (2 tabletter a 400 mg darunavir eller 1 tablet a 800 mg darunavir) sammen med 150 mg cobicistat eller 100 mg ritonavir en gang dagligt.
Dose for adults who have taken antiretroviral medicines before (your doctor will determine this) The dose is either: - 800 milligram darunavir (2 tablets containing 400 milligram of darunavir or 1 tablet containing 800 milligram of darunavir) together with 150 milligram cobicistat or 100 milligram ritonavir once daily.
For oplysninger om cobicistat, se i produktresuméet for cobicistat.
For information on cobicistat, consult the cobicistat Summary of Product Characteristics.
Co-administration af darunavir/cobicistat med lægemidler, som er potente induktorer af CYP3A (f.eks. perikon, rifampicin, carbamazepin, phenobarbital og phenytoin) er kontraindiceret (se pkt.
Darunavir boosted with cobicistat is more sensitive to CYP3A induction than ritonavir-boosted darunavir: co-administration of darunavir/cobicistat with medicinal products that are strong inducers of CYP3A (e.g. St John's wort, rifampicin, carbamazepine, phenobarbital, and phenytoin) is contraindicated (see section 4.3).
Med CD4+ celletal < 200 ved baseline d
With baseline CD4+ cell count < 200
Darunavir Mylan 75 mg filmovertrukne tabletter er hvide/offwhite, ovale med to kurvede sider, mærket med M på den ene side og DV1 på den anden side.
Darunavir Mylan 75 mg film-coated tablets are white to off-white, oval shaped with two curved sides, marked with M on one side and DV1 on the other side.
Dosering to gange dagligt Legemsvægt
Twice daily dosing
Der kan derfor være forskellige kontraindikationer og anbefalinger for darunavir og samtidige lægemidler afhængigt af, om darunavir er boostet med ritonavir eller cobicistat (se pkt.
Darunavir may therefore have different contraindications and recommendations for concomitant medications depending on whether the compound is boosted with ritonavir or cobicistat (see sections 4.3, 4.4 and 4.5).
Ved 48-ugers-analysen blev non-inferioritet i virologisk respons over for darunavir/ritonavir behandlingen, defineret som procentdelen af patienter med plasma hiv-1-RNA niveau < 50 kopier/ml, blev påvist (ved den forud definerede 12% non-inferioritetsgrænse) hos begge populationer (”Intent-To-Treat” og ”On Protocol”).
Non-inferiority in virologic response to the darunavir/ritonavir treatment, defined as the percentage of patients with plasma HIV-1 RNA level < 50 copies/ml, was demonstrated (at the pre-defined 12% non-inferiority margin) for both Intent-To-Treat (ITT) and On Protocol (OP) populations in the 48 week analysis.
Darunavir Mylan 75 mg filmovertrukne tabletter darunavir
Darunavir Mylan 75 mg film-coated tablets darunavir
Kombination af avanafil og boostet darunavir er kontraindiceret (se pkt.
The combination of avanafil and boosted darunavir is contraindicated (see section 4.3).
Filmovertrukne tabletter 30 filmovertrukne tabletter 120 filmovertrukne tabletter
30 film-coated tablets 120 film-coated tablets
- Rifabutin (mod bakterielle infektioner) - Sildenafil, vardenafil, tadalafil (til behandling af rejsningsbesvær eller højt blodtryk i det pulmonale kredsløb) - Amitriptylin, desipramin, imipramin, nortriptylin, paroxetin, sertralin, trazodon (til behandling af depression og angst) - Maraviroc (til behandling af hiv-infektion) - Metadon (til behandling af opiatafhængighed) - Carbamazepin, clonazepam (til forhindring af krampeanfald eller til behandling af visse typer nervesmerter) - Colchicin (til behandling af urinsyregigt eller familiær middelhavsfeber) - Bosentan (til behandling af højt blodtryk i det pulmonale kredsløb) - Buspiron, clorazepat, diazepam, estazolam, flurazepam, midazolam, når det tages som injektion, zoldipem (beroligende midler)
- Rifabutin (against bacterial infections) - Sildenafil, vardenafil, tadalafil (for erectile dysfunction or high blood pressure in the pulmonary circulation) - Amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone (to treat depression and anxiety) - Maraviroc (to treat HIV infection) - Methadone (to treat opiate dependance) - Carbamazepine, clonazepam (to prevent seizures or to treat certain types of nerve pain) - Colchicine (to treat gout or familial Mediterranean fever) - Bosentan (to treat high blood pressure in the pulmonary circulation) - Buspirone, clorazepate, diazepam, estazolam, flurazepam, midazolam when used as injection,
En dosis ritonavira er mellem 15 og 30 kg
One ritonavir a dose is between 15 and 30 kilograms 600 milligram
Hvid/offwhite, kapselformede, bikonvekse, filmovertrukne tabletter, ca. 12,75 mm x 6,3 mm, præget med 'M' på den ene side og 'DV2' på den anden side.
White to off-white, capsule shaped, biconvex film-coated tablets approximately 12.75 mm by 6.3 mm debossed with ‘M' on one side and ‘DV2' on the other side.
Samtidig administration af darunavir med lavdosis ritonavir, lurasidon, pimozid eller sertindol er kontraindiceret.
Concominant administration of darunavir with low dose ritonavir and lurasidone, pimozide or sertindole is contraindicated (see section 4.3).
Darunavir Mylan 800 mg filmovertrukne tabletter PVC/PE/PVDC-Al-blisterpakning, der indeholder 30 tabletter og 30 x 1 tabletter.
Darunavir Mylan 800 mg film-coated tablets PVC/PE/PVDC-Al blister pack containing 30 tablets and 30x1 tablets.
Hiv-1 RNA < 50 kopier/ml a
HIV-1 RNA < 50 copies/ml a
Darunavir Mylan 800 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 800 mg darunavir.
Darunavir Mylan 800 mg film-coated tablets Each film-coated tablet contains 800 mg of darunavir.
Hver tablet indeholder 600 mg darunavir.
Each tablet contains 600 milligram of darunavir.
forstoppelse, ræben - nyresvigt, nyresten, besvær med vandladning, hyppig eller overdreven vandladning til tider om natten - nældefeber, alvorlige hævelser i huden eller andre væv (hyppigst læber eller øjne), eksem,
problems with your balance - difficulty breathing, cough, nosebleed, throat irritation - inflammation of the stomach or mouth, heartburn, retching, dry mouth, discomfort of the abdomen, constipation, belching - kidney failure, kidney stones, difficult discharge of urine, frequent or excessive passage of urine, sometimes at night - urticaria, severe swelling of the skin and other tissues (most often the lips or the eyes), eczema,
De farmakokinetiske egenskaber af darunavir i kombination med ritonavir en gang dagligt hos 12 ART-naive pædiatriske patienter i alderen 12 til < 18 år med en legemsvægt på mindst 40 kg viste, at darunavir/ritonavir 800/100 mg en gang dagligt resulterede i en darunavireksponering, der var sammenlignelig med eksponeringen hos voksne, der fik darunavir/ritonavir 800/100 mg en gang dagligt.
The pharmacokinetics of darunavir in combination with ritonavir taken once daily in 12 ART-naïve paediatric patients, aged 12 to < 18 years and weighing at least 40 kg, showed that darunavir/ritonavir 800/100 mg once daily results in darunavir exposure that was comparable to that achieved in adults receiving darunavir/ritonavir 800/100 mg once daily.
Produktresuméet for ritonavir, som det måtte være relevant, skal derfor læses, inden behandling med darunavir påbegyndes.
Characteristics of ritonavir as appropriate, must therefore be consulted prior to initiation of therapy with darunavir.
Hver tablet indeholder 400 mg darunavir.
Each tablet contains 400 milligrams of darunavir.
MIDLER MOD ANGINA PECTORIS/ANTIARYTMIKA Disopyramid
ANTIANGINA/ANTIARRHYTHMIC Disopyramide
Hver tablet indeholder 800 mg darunavir.
Each tablet contains 800 milligram of darunavir.
Behandlingsnaive darunavir/cobicistat 800/150 mg en gang dagligt + OBR N=295
Treatment-naïve darunavir/cobicistat 800/150 mg once daily + OBR N=295
Darunavir Mylan 600 mg filmovertrukne tabletter fås i blisterkort med 30 og 60 tabletter og i plastikflasker med 30, 60 og 90 tabletter.
Darunavir Mylan 600 mg film-coated tablets are available in blister packs containing 30 and 60 tablets and in plastic bottles containing 30, 60 and 90 tablets.
Antal deltagere med virologisk svigt og parrede genotyper ved baseline og endepunkt, der udviklede mutationer b ved endepunktet, n/N Primære (major) PI-mutationer PI RAMs Antal deltagere med virologisk svigt og parrede fænotyper ved baseline/endepunkt, der udviste tab af følsomhed over for PI'er ved endepunktet sammenlignet med baseline, n/N PI
Number of subjects with virologic failure and paired baseline/endpoint phenotypes, showing loss of susceptibility to PIs at endpoint compared to baseline, n/N PI darunavir amprenavir atazanavir indinavir lopinavir saquinavir tipranavir a TLOVR non-VF censored algorithm based on HIV-1 RNA < 50 copies/ml, except for TITAN (HIV-1 RNA <
Hver filmovertrukken tablet indeholder 800 mg darunavir.
Each film-coated tablet contains 800 mg of darunavir.
- Rifabutin (mod bakterielle infektioner) - Sildenafil, vardenafil, tadalafil (til behandling af rejsningsbesvær eller højt blodtryk i det pulmonale kredsløb) - Amitriptylin, desipramin, imipramin, nortriptylin, paroxetin, sertralin, trazodon (til behandling af depression og angst) - Maraviroc (til behandling afhiv-infektion) - Metadon (til behandling af opiatafhængighed) - Carbamazepin, clonazepam (til forhindring af krampeanfald eller til behandling af visse typer nervesmerter) - Colchicin (til behandling af urinsyregigt eller familiær middelhavsfeber) - Bosentan (til behandling af højt blodtryk i det pulmonale kredsløb)
- Rifabutin (against bacterial infections) - Sildenafil, vardenafil, tadalafil (for erectile dysfunction or high blood pressure in the pulmonary circulation) - Amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone (to treat depression and anxiety) - Maraviroc (to treat HIV infection) - Methadone (to treat opiate dependance) - Carbamazepine, clonazepam (to prevent seizures or to treat certain types of nerve pain) - Colchicine (to treat gout or familial Mediterranean fever) - Bosentan (to treat high blood pressure in the pulmonary circulation)
Virkning af darunavir 800 mg en gang dagligt co-administreret med 100 mg ritonavir en gang dagligt hos ART-erfarne patienter.
Efficacy of darunavir 800 mg once daily co-administered with 100 mg ritonavir once daily in ART-experienced patients
d a
d d
Hver filmovertrukken tablet indeholder 150 mg darunavir.
Each film-coated tablet contains 150 mg of darunavir.
Darunavir: sammenligning af darunavir/ritonavir 400/100 mg x 2 vs darunavir/ritonavir 400/100 mg i kombination med indinavir 800 mg x 2.
Darunavir: comparison of darunavir/ritonavir 400/100 mg twice daily vs. darunavir/ritonavir 400/100 mg in combination with indinavir 800 mg twice daily.
Samtidig administration af boostet Darunavir Mylan og dabigatran eller ticagrelor er kontraindiceret (se pkt.
Concomitant administration of boosted darunavir with dabigatran or ticagrelor is contraindicated (see section 4.3).
Darunavir Mylan 400 mg filmovertrukne tabletter fås i blisterkort med 30 og 60 tabletter og i HDPEflasker med 60 og 100 tabletter.
Darunavir Mylan 400 mg film-coated tablets are available blister packs containing 30 and 60 tablets and in the HDPE bottles of 60 and 100 tablets.
Sådan skal du tage Darunavir Mylan
How to take Darunavir Mylan
30 filmovertrukne tabletter 30 x 1 filovertrukken tablet
Blister carton 30 film-coated tablets 30 x 1 film-coated tablets
Kontakt din læge, hvis du får udslæt.
Please contact your doctor whenever you develop a rash.
<Kun flasker> Skal anvendes inden for 100 dage efter anbrud.
<Bottles Only> Once opened, use within 100 days
Darunavir Mylan 800 mg tabletter anvendes kun til at sammensætte en daglig dosis på 800 mg.
Darunavir Mylan 800 mg tablets are intended for once daily use only.
Darunavir Mylan 800 mg filmovertrukne tabletter er hvide/offwhite, ovale med to kurvede sider, mærket med M på den ene side og DV8 på den anden side.
Darunavir Mylan 800 mg film-coated tablets are white to off-white, oval shaped, with two curved sides, marked with M on one side and DV8 on the other side.
(CYP3A- og/eller P-gp-hæmning)
(CYP3A and/ or P-gp inhibition)
Elimination Efter en
Elimination
De farmakokinetiske egenskaber af darunavir i kombination med ritonavir to gange dagligt hos 74 behandlingserfarne pædiatriske patienter i alderen 6 til 17 år med en legemsvægt på mindst 20 kg viste, at vægtbaserede doser af darunavir/ritonavir resulterede i en darunavireksponering, der var sammenlignelig med eksponeringen hos voksne, der fik darunavir/ritonavir 600/100 mg to gange dagligt (se pkt.
The pharmacokinetics of darunavir in combination with ritonavir taken twice daily in 74 treatmentexperienced paediatric patients, aged 6 to 17 years and weighing at least 20 kg, showed that the administered weight-based doses of darunavir/ritonavir resulted in darunavir exposure comparable to that in adults receiving darunavir/ritonavir 600/100 mg twice daily (see section 4.2).
Darunavir Mylans udseende og pakningsstørrelser
What Darunavir Mylan looks like and contents of the pack
(hæmning af CYP enzymer)
(inhibition of CYP450 enzymes)
Darunavir Mylan 150 mg filmovertrukne tabletter EU/1/16/1140/006
Darunavir Mylan 150 mg film-coated tablets EU/1/16/1140/006
Dosis til børn fra 3 år og opefter med en legemsvægt på mindst 40 kg, som har taget antiretrovirale lægemidler før (barnets læge vil afgøre dette) Dosis er enten: - 800 mg darunavir (2 tabletter a 400 mg darunavir eller 1 tablet a 800 mg darunavir) sammen med 100 mg ritonavir en gang dagligt.
Dose for children 3 years of age and above, weighing more than 40 kilograms who have not taken antiretroviral medicines before (your child's doctor will determine this) - The usual dose of darunavir is 800 milligram (2 tablets containing 400 milligram of darunavir or 1 tablet containing 800 milligram of darunavir) together with 100 milligram ritonavir once daily.
Flasker: Skal anvendes inden for 100 dage efter anbrud.
For bottles: Once opened, use within 100 days.
Darunavir/ritonavir 600/100 mg x 2 + OBR N=296
Darunavir/ritonavir 600/100 mg twice daily + OBR N=296
Behandlingserfarne darunavir/cobicistat 800/150 mg en gang dagligt + OBR N=18
Treatment-experienced darunavir/cobicistat 800/150 mg once daily + OBR N=18
Darunavir Mylan 400 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 400 mg darunavir.
Darunavir Mylan 400 mg film-coated tablets Each film-coated tablet contains 400 mg of darunavir.
Darunavir Mylan 150 mg filmovertrukne tabletter
Darunavir Mylan 150 mg film-coated tablets
Darunavir Mylan 300 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 300 mg darunavir.
Darunavir Mylan 300 mg film-coated tablets Each film-coated tablet contains 300 mg of darunavir.
Darunavir/ ritonavir 800/100 mg en gang dagligt N=294
Darunavir/ ritonavir 800/100 mg once daily N=294
Hvid/offwhite, ovale, bikonvekse, filmovertrukne tabletter, ca. 9,7 mm x 4,6 mm, præget med 'M' på den ene side og 'DV1' på den anden side.
White to off-white, oval shaped, biconvex film-coated tablets approximately 9.7 mm by 4.6 mm, debossed with ‘M' on one side and ‘DV1' on the other side.
Hver filmovertrukken tablet indeholder 300 mg darunavir.
Each film-coated tablet contains 300 mg of darunavir.
CD4+ celletal gennemsnitlig ændring fra baseline b a
CD4+ cell count mean change from baseline b a
Darunavir Mylan 800 mg filmovertrukne tabletter fås i blisterkort med 30 tabletter og i plastbeholder med 30, 60 og 90 tabletter.
Darunavir Mylan 800 mg film-coated tablets are available in blister packs containing 30 tablets and in plastic bottles containing 30, 60 and 90 tablets.
Darunavir Mylan 400 mg filmovertrukne tabletter PVC/PE/PVDC-Al-blisterpakning, der indeholder 30 og 60 tabletter og 60 x 1 tabletter.
Darunavir Mylan 400 mg film-coated tablets PVC/PE/PVDC-Al blister pack containing 30 and 60 tablets and 60x1 tablets.
Darunavir Mylan 600 mg filmovertrukne tabletter er hvide/offwhite, ovale med to kurvede sider, mærket med M på den ene side og DV5 på den anden side.
Darunavir Mylan 600 mg film-coated tablets are white to off-white, oval shaped, with two curved sides, marked with M on one side and DV5 on the other side.
Hver filmovertrukken tablet indeholder 400 mg darunavir.
Each film-coated tablet contains 400 mg of darunavir.