natgillin/translations-raw huggingface dataset:
REYATAZ er i kontrollerede kliniske studier evalueret for sikkerhed i kombinationsbehandling med andre antiretrovirale lægemidler hos 1.806 voksne patienter behandlet med REYATAZ 400 mg, én gang dagligt (1.151 patienter, 52 ugers middelvarighed og 152 ugers maksimal varighed) eller REYATAZ 300 mg med ritonavir 100 mg én gang dagligt (655 patienter, 96 ugers middelvarighed og 108 ugers maksimal varighed).
REYATAZ has been evaluated for safety in combination therapy with other antiretroviral medicinal products in controlled clinical trials in 1,806 adult patients receiving REYATAZ 400 mg once daily (1,151 patients, 52 weeks median duration and 152 weeks maximum duration) or REYATAZ 300 mg with ritonavir 100 mg once daily (655 patients, 96 weeks median duration and 108 weeks maximum duration).
Samtidig administration med REYATAZ kan øge eller reducere koncentrationen af warfarin.
Co-administration with REYATAZ has the potential to increase or decrease warfarin concentrations.
Samtidig indtag af enkeltdosis REYATAZ 300 mg og ritonavir 100 mg og et let måltid medførte en stigning i AUC på 33% og en stigning i såvel Cmax som 24-timerskoncentrationen af atazanavir på 40% i forhold til i fastende tilstand.
Co-administration of a single 300 mg dose of REYATAZ and 100 mg dose of ritonavir with a light meal resulted in a 33% increase in the AUC and a 40% increase in both the Cmax and the 24 hour concentration of atazanavir relative to the fasting state.
Udslæt er ofte lette til moderate makulopapuløse huderuptioner, der optræder inden for de første 3 uger efter påbegyndelse af REYATAZ-behandling.
Rashes are usually mild-to-moderate maculopapular skin eruptions that occur within the first 3 weeks of starting therapy with REYATAZ.
Barnet skal drikke hele den resterende blanding.
The child is to drink the entire residual mixture.
Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Dosis af REYATAZ oralt pulver til børn beregnes ud fra barnets vægt og skal tages en gang dagligt sammen med mad og ritonavir som vist i tabellen nedenfor:
The dose of REYATAZ oral powder for children is calculated by body weight and is taken once daily with food and ritonavir as shown below:
REYATAZ er ikke undersøgt hos børn under 3 måneder og bør ikke anvendes på grund af den potentielle risiko for kernicterus.
REYATAZ has not been studied in children less than 3 months of age and is not recommended because of the potential risk of kernicterus.
Nedsat nyrefunktion: Dosisjustering er ikke påkrævet hos patienter med nedsat nyrefunktion.
Renal impairment: No dosage adjustment is needed in patients with renal impairment.
Yderligere 10 ml modermælkserstatning hældes i medicinkoppen eller den lille beholder for at skylle det resterende REYATAZ oralt pulver ud af koppen eller beholderen.
Another 10 ml of formula is poured into the medicine cup or small container to rinse off remaining REYATAZ oral powder in the cup or container.
hiv-RNA <50 kopier/ml ved selekteret baseline PI substitutioner,f, g % (respons/evaluerbar) NA
HIV RNA <50 copies/ml by select baseline PI substitutions,f, g % (responder/evaluable) NA
Tilberedning og indgivelse af medicinen sammen med modermælkserstatning i en medicinkop eller lille beholder og en mundsprøjte (spørg efter en mundsprøjte på apotektet):
Preparing and giving the medicine with liquid infant formula using a medicine cup or small container and oral syringe (ask your pharmacist for an oral syringe):
Hver karton indeholder 30 x 1 kapsel; 5 blisterkort med 6 x 1 kapsel hver i alu/alu-perforeret enkeltdosis-blisterpakning.
Each carton contains 30 x 1 capsules; 5 blister cards of 6 x 1 capsules each in Alu/Alu perforated unit dose blisters.
CD4 Middelændring fra baseline, celler/mm3 ved baseline karakteristika hiv-RNA <100.000 kopier/ml
CD4 Mean Change from Baseline, cells/mm3 by Baseline Characteristic HIV RNA <100,000 copies/ml
Bivirkninger var ensartede mellem patienter, der fik 400 mg REYATAZ én gang dagligt, og patienter, der fik 300 mg REYATAZ med ritonavir 100 mg én gang dagligt, med undtagelse af, at der hyppigere indberettedes gulsot og forhøjede niveauer af totalbilirubin ved REYATAZ plus ritonavir.
Adverse reactions were consistent between patients who received REYATAZ 400 mg once daily and patients who received REYATAZ 300 mg with ritonavir 100 mg once daily, except that jaundice and elevated total bilirubin levels were reported more frequently with REYATAZ plus ritonavir.
Ved uge 48 fik 134 pædiatriske patienter i alderen 3 måneder til under 11 år REYATAZ oralt pulver sammen med ritonavir, hvis virkning belv undersøgt.
At Week 48 there were 134 paediatric patients aged 3 months to less than 11 years that received REYATAZ oral powder with ritonavir that were evaluated for efficacy.
Der er ikke tilstrækkelige kliniske data fra dette studie til at understøtte brugen af atazanavir-kapsler (med eller uden ritonavir) hos børn under 6 år.
The clinical data derived from this study are inadequate to support the use of atazanavir capsules (with or without ritonavir) in children below 6 years of age.
Hver karton indeholder 60 x 1 kapsel; 10 blisterkort med 6 x 1 kapsel hver i alu/alu-perforeret enkeltdosis-blisterpakning.
Each carton contains 60 x 1 capsules; 10 blister cards of 6 x 1 capsules each in Alu/Alu perforated unit dose blisters.
En eller tre beholdere med 30 hårde kapsler i en æske.
Either one or three bottles of 30 hard capsules are provided in one carton.
Norbuprenorphin AUC ↑105% Norbuprenorphin Cmax ↑61% Norbuprenorphin Cmin ↑101%
Norbuprenorphine AUC ↑105% Norbuprenorphine Cmax ↑61% Norbuprenorphine Cmin ↑101%
Behandlingserfaren REYATAZ pulver/ritonavir n=82
Treatment-Experienced REYATAZ Powder/ritonavir n=82
Se også PULMONAL ARTERIEL HYPERTENSION i denne tabel for yderligere information om samtidig administration af REYATAZ og sildenafil.
Also see PULMONARY ARTERIAL HYPERTENSION in this table for further information regarding coadministration of REYATAZ with sildenafil.
Samtidig administration af REYATAZ med ritonavir kræver overvågning for sedation og kognitiv påvirkning.
Co-administration with REYATAZ with ritonavir warrants clinical monitoring for sedation and cognitive effects.
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ Oral anvendelse.
METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Interaktioner mellem atazanavir/ritonavir og proteasehæmmere, andre antiretrovirale præparater end proteasehæmmere og andre lægemidler angives i tabellen nedenfor (stigninger er angivet med “↑”, fald med “↓”, ingen ændring med “↔”).
Interactions between atazanavir/ritonavir and protease inhibitors, antiretroviral agents other than protease inhibitors, and other non-antiretroviral medicinal products are listed in the table below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”).
Samtidig administration frarådes derfor.
Therefore, such coadministration is not recommended.
Det vides ikke, om REYATAZ administreret til moderen under graviditet, vil forstærke fysiologisk hyperbilirubinæmi og medføre kernicterus hos nyfødte og spædbørn.
It is not known whether REYATAZ administered to the mother during pregnancy will exacerbate physiological hyperbilirubinaemia and lead to kernicterus in neonates and infants.
REYATAZ oralt pulver kan anvendes til børn på over 3 måneder og som vejer mindst 5 kg (se afsnit 3 Sådan skal du tage REYATAZ).
REYATAZ oral powder may be used by children at least 3 months of age and weighing at least 5 kg (see section 3 How to take REYATAZ).
Uge 48: -3% [-7,6%, 1,5%] Uge 96: 2,2% [-2,3%, 6,7%] hiv-RNA <50 kopier/ml, % ved Baseline Karakteristikad hiv-RNA <100.000 kopier/ml
Week 48: -3% [-7.6%, 1.5%] Week 96: 2.2% [-2.3%, 6.7%] HIV RNA <50 copies/ml, % by Baseline Characteristicd HIV RNA <100,000 copies/ml
Hver beholder indeholder 30 hårde kapsler.
Each bottle contains 30 hard capsules.
Didanosin (tabletter med buffer) 200 mg/stavudin 40 mg, begge som enkeltdoser (atazanavir 400 mg som enkeltdosis)
Didanosine (buffered tablets) 200 mg/stavudine 40 mg, both single dose (atazanavir 400 mg single dose)
Det anbefales at skifte til REYATAZ-kapsler fra REYATAZ oralt pulver, så snart patienten konsekvent er i stand til at sluge kapsler.
Switching to REYATAZ capsules from REYATAZ oral powder is encouraged as soon as patients are able to consistently swallow capsules.
Til mindre spædbørn (under 6 måneder), som ikke kan spise fast føde eller drikke af en kop, blandes REYATAZ oralt pulver med modermælkserstatning og gives ved hjælp af en mundsprøjte, som kan fås på apoteket.
For young infants (less than 6 months) who cannot eat solid food or drink from a cup, REYATAZ oral powder should be mixed with infant formula and given using an oral syringe, which can be obtained from a pharmacist.
Samtidig administration af lamotrigin og REYATAZ/ritonavir kan reducere plasmakoncentrationen af lamotrigin på grund af UGT1A4-induktion.
Co-administration of lamotrigine and REYATAZ/ritonavir may decrease lamotrigine plasma concentrations due to UGT1A4 induction.
Patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption bør ikke tage dette lægemiddel.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicinal product.
I kliniske studier med patienter, der ikke tidligere har modtaget antiretroviral behandling, og som behandles med boostet atazanavir, forekom der ikke I50-substitution hos nogen af patienterne uden baseline PI-substitution.
In clinical trials of antiretroviral treatment naive patients treated with boosted atazanavir, the I50L substitution did not emerge in any patient without baseline PI substitutions.
Samtidig administration af diltiazem og REYATAZ/ritonavir er ikke undersøgt.
Co-administration of diltiazem and REYATAZ/ritonavir has not been studied.
Buprenorphin AUC ↑67% Buprenorphin Cmax ↑37% Buprenorphin Cmin ↑69%
Buprenorphine AUC ↑67% Buprenorphine Cmax ↑37% Buprenorphine Cmin ↑69%
Det skal du vide, før du begynder at tage REYATAZ
What you need to know before you take REYATAZ
Det vides ikke, om REYATAZ med ritonavir administreret til moderen under graviditet, vil forstærke fysiologisk hyperbilirubinæmi og medføre kernicterus hos nyfødte og spædbørn.
It is not known whether REYATAZ with ritonavir administered to the mother during pregnancy will exacerbate physiological hyperbilirubinaemia and lead to kernicterus in neonates and infants.
Hæmofilipatienter: Der har været rapporter om øget blødning, inklusive spontane hudhæmatomer og hæmarthrose, hos type A og B hæmofile patienter, der havde fået behandling med proteasehæmmere.
Haemophiliac patients: There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthroses, in type A and B haemophiliac patients treated with protease inhibitors.
QT-forlængelse: Der er i kliniske studier observeret dosisrelaterede, asymptomatiske forlængelser i PR-intervallet med REYATAZ.
QT prolongation: Dose related asymptomatic prolongations in PR interval with REYATAZ have been observed in clinical studies.
REYATAZ oralt pulver, administreret sammen med lavdosis ritonavir, er indiceret i kombination med andre antiretrovirale lægemidler til behandling af hiv-1 inficerede pædiatriske patienter, der er mindst 3 måneder og vejer mindst 5 kg (se pkt.
REYATAZ oral powder, co-administered with low dose ritonavir, is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected paediatric patients at least 3 months of age and weighing at least 5 kg (see section 4.2).
Ved samtidig administration af REYATAZ og ritonavir kan ritonavirs metaboliske lægemiddelinteraktionsprofil dominere, idet ritonavir er en mere potent CYP3A4-hæmmer end atazanavir.
When REYATAZ and ritonavir are co-administered, the metabolic drug interaction profile for ritonavir may predominate because ritonavir is a more potent CYP3A4 inhibitor than atazanavir.
mindst 5 til mindre end 15
At least 5 to less than 15
Blisterpakning: 60 hårde kapsler
Blister pack: 60 hard capsules
Pædiatrisk population Pædiatriske studier med REYATAZ-kapsler
Paediatric trials with REYATAZ capsules
REYATAZ fås også som oralt pulver til børn på over 3 måneder, som vejer mindst 5 kg.
REYATAZ is also available as an oral powder for use in children at least 3 months old and weighing at least 5 kg.
De novo substitutioner hos behandlingserfarne patienter med svigt i behandling med atazanavir + ritonavir (studie 045, 48 uger)
De novo substitutions in treatment naive patients failing therapy with atazanavir + ritonavir (Study 138, 96 weeks)
Patienterne bør informeres om, at der er indberettet svimmelhed ved behandling med regimer indeholdende REYATAZ (se pkt.
Patients should be informed that dizziness has been reported during treatment with regimens containing REYATAZ (see section 4.8).
For at undgå overførsel af hiv anbefales det generelt, at hivinficerede mødre ikke ammer deres spædbørn.
As a general rule, it is recommended that HIV infected women not breast-feed their infants in order to avoid transmission of HIV.
REYATAZ-kapsler, administreret sammen med en lav dosis ritonavir, er indiceret til behandling af hiv-1-infektion hos voksne og børn fra 6 år og ældre i kombination med andre antiretrovirale lægemidler (se pkt.
REYATAZ capsules, co-administered with low dose ritonavir, are indicated for the treatment of HIV1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products (see section 4.2).
Der var færre behandlingsafbrydelser i gruppen med ikke-boostet REYATAZ (1 versus 4 i gruppen med REYATAZ + ritonavir).
There were fewer treatment discontinuations in the unboosted REYATAZ group (1 vs. 4 subjects in the REYATAZ + ritonavir group).
Den resterende blanding trækkes op i sprøjten og indgives i enten i barnets højre eller venstre kindhule.
The residual mixture is drawn up into the syringe and administered into either the right or left inner cheek of the infant.
Der er ikke gennemført interaktionsstudier af samtidig administration af REYATAZ og benzodiazepiner.
No drug interaction study has been performed for the coadministration of REYATAZ with benzodiazepines.
Dosisjustering er ikke nødvendig for REYATAZ.
No dose adjustment is needed for REYATAZ.
REYATAZ kan påvirke din nyrefunktion.
REYATAZ may affect how well your kidneys work.
Lægen kan vælge at justere dosis af REYATAZ, hvis det er relevant i forhold til din behandling.
Your doctor may adjust the dose of REYATAZ according to your anti-HIV therapy.
Samtidig administration af atorvastatin og REYATAZ frarådes.
Co-administration of atorvastatin with REYATAZ is not recommended.
Administration sammen med REYATAZ kan medføre en stor stigning i koncentrationen af disse benzodiazepiner.
Co-administration with REYATAZ may cause a large increase in the concentration of these benzodiazepines.
LÆGEMIDDELFORM OG ANTAL (PAKNINGSSTØRRELSE) Æske og etiket til beholderpakning (1 beholder): 60 hårde kapsler Blisterpakning: 60 hårde kapsler
PHARMACEUTICAL FORM AND CONTENTS Carton and label bottle pack (1 bottle): 60 hard capsules Blister pack: 60 hard capsules
Bestem dosis og det nødvendige antal breve med REYATAZ oralt pulver (se afsnit 3 Sådan skal du tage REYATAZ).
Determine the dose and the number of REYATAZ oral powder sachets needed (see section 3 How to take REYATAZ).
Hver æske indeholder en HDPE-beholder (high density polyethylen) med børnesikret polypropylenlåg.
Each carton contains one high-density polyethylene (HDPE) bottle closed with child-resistant polypropylene closure.
Pædiatriske patienter (mindst 3 måneder og med en legemsvægt på mindst 5 kg): REYATAZ oralt pulver fås til pædiatriske patienter, som er mindst 3 måneder og vejer mindst 5 kg (se produktresumeet for REYATAZ oralt pulver).
Paediatric patients (at least 3 months of age and weighing at least 5 kg): REYATAZ oral powder is available for paediatric patients at least 3 months of age and weighing at least 5 kg (see Summary of Product Characteristics for REYATAZ oral powder).
I en per protokolanalyse, som udelukkede non-completers (dvs. patienter, der ophørte med behandlingen før hiv-RNA-vurdering ved uge 48) og patienter med væsentlige afvigelser fra undersøgelsesprotokolen, var andelen af patienter med hiv-RNA < 50 kopier/ml ved uge 48 86% (338/392) for REYATAZ/ritonavir og 89% (332/372) for lopinavir/ritonavir (estimeret forskel på ATV/RTV-LPV/RTV: -3% [95% CI, -7,6%; 1,5%].
In a per protocol analysis which excluded non-completers (i.e. patients who discontinued before the week 48 HIV RNA assessment) and patients with major protocol deviations, the proportion of patients with HIV RNA < 50 copies/ml at week 48 was 86% (338/392) for REYATAZ/ritonavir and 89% (332/372) for lopinavir/ritonavir (difference estimate of ATV/RTV-LPV/RTV: -3% [95% CI, -7.6%,
De hyppigst rapporterede laboratoriemæssige anormaliteter hos pædiatriske patienter i behandling med REYATAZ oralt pulver var forhøjet total-bilirubin (≥ 2,6 gange ULN, grad 3-4; 16%) og forhøjet amylase (grad 3-4; 33%), generelt ikke udgået fra pancreas.
The most frequently reported laboratory abnormalities in paediatric patients receiving REYATAZ oral powder was elevation of total bilirubin (≥ 2.6 times ULN, Grade 3-4; 16%) and increased amylase (Grade 3-4; 33%), generally of non-pancreatic origin.
Hos hiv-inficerede patienter (n=13) medførte gentagne doser af REYATAZ 400 mg (uden ritonavir) en gang dagligt med føde en geometrisk gennemsnitlig (CV%) atazanavir-Cmax på 2.298 (71) ng/ml, med en tid til Cmax på ca. 2,0 timer.
In HIV-infected patients (n=13), multiple dosing of REYATAZ 400 mg (without ritonavir) once daily with food produced a geometric mean (CV%) for atazanavir Cmax of 2298 (71) ng/ml, with time to Cmax of approximately 2.0 hours.
Brug af anden medicin sammen med REYATAZ Du må ikke tage REYATAZ sammen med visse andre lægemidler.
You must not take REYATAZ with certain medicines.
Børn, som kan drikke af en kop, skal have REYATAZ oralt pulver sammen med væske eller mad.
For children who are able to drink from a cup, REYATAZ oral powder must be taken with food or drinks.
Ved behov for samtidig administration af REYATAZ og en NNRTI, kan det overvejes at øge dosis af REYATAZ og ritonavir til henholdsvis 400 mg og 200 mg, i kombination med efavirenz, og under omhyggelig klinisk monitorering.
If the co-administration of REYATAZ with an NNRTI is required, an increase in the dose of both REYATAZ and ritonavir to 400 mg and 200 mg, respectively, in combination with efavirenz could be considered with close clinical monitoring.
EXP {MM/ÅÅÅÅ}
EXPIRY DATE EXP {MM/YYYY}
REYATAZ bør seponeres, hvis der udvikles alvorligt udslæt.
REYATAZ should be discontinued if severe rash develops.
Tre ud af 20 spædbørn (15%) født af kvinder i behandling med REYATAZ/ritonavir 300/100 mg og 4 ud af 20 spædbørn (20%) født af kvinder i behandling med REYATAZ/ritonavir 400/100 mg oplevede grad 3-4 bilirubin.
Three of 20 infants (15%) born to women treated with REYATAZ/ritonavir 300/100 mg and four of 20 infants (20%) born to women treated with REYATAZ/ritonavir 400/100 mg experienced grade 3-4 bilirubin.
Du må ikke bruge en sutteflaske, når du skal give REYATAZ blandet med modermælkserstatning.
Do not use an infant bottle to give REYATAZ mixed with infant formula.
Følgende andre bivirkninger er rapporteret hos patienter, som har været behandlet med REYATAZ: Almindelige (kan forekomme hos op til 1 ud af 10 personer): hovedpine opkastning, diarré, smerter i bughulen (ubehagelige mavesmerter), kvalme, fordøjelsesbesvær voldsom træthed
Other side effects reported for patients treated with REYATAZ are the following: Common (may affect up to 1 in 10 people): headache vomiting, diarrhoea, abdominal pain (stomach pain of discomfort), nausea, dyspepsia (indigestion) fatigue (extreme tiredness)
Indeholder aspartam og saccharose.
LIST OF EXCIPIENTS Contains aspartame and sucrose.
Interaktioner med andre lægemidler Kombination af REYATAZ og atorvastatin frarådes (se pkt.
Interactions with other medicinal products The combination of REYATAZ with atorvastatin is not recommended (see section 4.5).
Du må ikke tage sildenafil sammen med REYATAZ, hvis sildenafil anvendes til behandling af pulmonal arteriel hypertension.
Do not take sildenafil with REYATAZ when sildenafil is used for the treatment of pulmonary arterial hypertension.
Se doseringstabellen for den pågældende formulering (se produktresumeet for REYATAZ oralt pulver).
Consult the dosing table for the specific formulation (see Summary of Product Characteristics for REYATAZ oral powder).
Hos børn, som ikke kan spise fast føde eller drikke af en kop, skal REYATAZ oralt pulver blandes med modermælkserstatning og bør gives med en mundsprøjte.
For children who cannot eat solid food or drink from a cup, REYATAZ oral powder must be mixed with infant formula and should be given using an oral syringe.
almindelig: gulsot ikke almindelig: hepatitis, cholelithiasisa, kolestasea sjælden: hepatosplenomegali, cholecystitisa
common: jaundice; uncommon: hepatitis, cholelithiasisa, cholestasisa; rare: hepatosplenomegaly, cholecystitisa
Stevens-Johnsons syndrom (SJS), erythema multiforme, toksiske huderuptioner og lægemiddelfremkaldt udslæt med eosinofili og systemiske symptomer (DRESS-syndrom) har været rapporteret hos patienter i behandling med REYATAZ.
Stevens-Johnson syndrome (SJS), erythema multiforme, toxic skin eruptions and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been reported in patients receiving REYATAZ.
hiv-RNA Middelændring fra baseline, log10 kopier/ml Alle patienter
HIV RNA Mean Change from Baseline, log10 copies/ml All patients
300 mg/ritonavir 100 mg og H2receptorantagonister administreres samtidigt, bør en dosis svarende til famotidin 20 mg 2 gange dagligt ikke overskrides.
300 mg/ritonavir 100 mg and H2-receptor antagonists are coadministered, a dose equivalent to famotidine 20 mg twice daily should not be exceeded.
REYATAZ/ritonavir-armen viste antiviral effekt svarende til lopinavir/ritonavir-armen (non-inferiør) vurderet ved andelen af patienter med hiv-RNA <50 kopier/ml ved uge 48: 78% af patienterne, der fik REYATAZ/ritonavir sammenligner med 76%, der fik lopinavir/ritonavir (estimeret forskel på ATV/RTV-LPV/RTV: 1,7% [95% CI, -3,8%; 7,1%] ifølge bekræftet virologisk respons (Confirmed Virologic Response - CVR) non-completer = Svigt (NC = F) definition af respons.
The REYATAZ/ritonavir arm has similar (non-inferior) antiviral efficacy compared to the lopinavir/ritonavir arm, as assessed by the proportion of patients with HIV RNA < 50 copies/ml at week 48: 78% of patients on REYATAZ/ritonavir compared to 76% on lopinavir/ritonavir (difference estimate of ATV/RTV-LPV/RTV: 1.7% [95% CI, -3.8%, 7.1%] according to the Confirmed Virologic Response (CVR) Non-Completer = Failure (NC = F) definition of response.
Patienter i behandling med REYATAZ, som har forhøjede levertransaminaser og forhøjet bilirubin samtidig, bør evalueres for alternative ætiologier.
Hepatic transaminase elevations that occur with elevated bilirubin in patients receiving REYATAZ should be evaluated for alternative aetiologies.
De farmakokinetiske data fra hiv-smittede gravide kvinder, der fik REYATAZ kapsler med ritonavir, er beskrevet i Tabel 9.
The pharmacokinetic data from HIV-infected pregnant women receiving REYATAZ capsules with ritonavir are presented in Table 9.
Koncentrationerne af atazanavir med eller uden ritonavir forventes at øges hos patienter med moderat eller alvorligt nedsat leverfunktion (se pkt.
Concentrations of atazanavir with or without ritonavir are expected to be increased in patients with moderately or severely impaired hepatic function (see sections 4.2, 4.3, and 4.4).
Ved AT-analyse, hvor manglende værdier blev ekskluderet, var andelen af patienter med hiv-RNA <400 kopier/ml (<50 kopier/ml) for REYATAZ+ ritonavir 84% (72%) og for lopinavir + ritonavir 82% (72%).
By as-treated analysis, excluding missing values, the proportions of patients with HIV RNA <400 copies/ml (<50 copies/ml) for REYATAZ + ritonavir were 84% (72%) and for lopinavir + ritonavir were 82% (72%).