natgillin/translations-raw huggingface dataset:
Pædiatriske patienter fra 3 måneder til under 11 år havde i de kliniske studier AI424-397 og AI424451 en gennemsnitlig behandlingsvarighed med REYATAZ oralt pulver på 80 uger.
In clinical studies AI424-397 and AI424-451, paediatric patients 3 months to less than 11 years of age had a mean duration of treatment with REYATAZ oral powder of 80 weeks.
Der kan hos nogle patienter med fremskreden hiv-infektion (aids) og med tidligere infektion, som skyldes nedsat immunforsvar, opstå tegn og symptomer på betændelse fra tidligere infektioner.
In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Der er ikke fastlagt en sikker og effektiv dosis for sildenafil i kombination med REYATAZ/ritonavir til behandling af pulmonal arteriel hypertension.
A safe and effective dose in combination with REYATAZ/ritonavir has not been established for sildenafil when used to treat pulmonary arterial hypertension.
På grund af phenytoins/phenobarbitals inducerende effekt kan nedsat eksponering for REYATAZ ikke udelukkes.
Due to phenytoin/phenobarbital inducing effect, a reduction in REYATAZ exposure cannot be ruled out.
Nevirapin AUC ↑26% (↑17% ↑36%) Nevirapin Cmax ↑21% (↑11% ↑32%) Nevirapin Cmin ↑35% (↑25% ↑47%)
Nevirapine AUC ↑26% (↑17% ↑36%) Nevirapine Cmax ↑21% (↑11% ↑32%) Nevirapine Cmin ↑35% (↑25% ↑47%)
Kombination af rifampicin med lavdosis ritonavir (se pkt.
Combination of rifampicin with concomitant low-dose ritonavir (see section 4.5).
Der er i kliniske studier observeret dosisrelaterede, asymptomatiske forlængelser i PR-intervallet med REYATAZ.
Dose related asymptomatic prolongations in PR interval with REYATAZ have been observed in clinical studies.
Ritonavir en daglig dosis* (mg)
Ritonavir Dose* once daily (mg)
Simvastatin og lovastatin metaboliseres i høj grad via CYP3A4 og samtidig administration med REYATAZ/ritonavir kan medføre øgede koncentrationer.
Simvastatin and lovastatin are highly dependent on CYP3A4 for their metabolism and co-administration with REYATAZ/ritonavir may result in increased concentrations.
Blandt behandlingsnaive patienter, der fik REYATAZ 300 mg én gang dagligt med 100 mg ritonavir én gang dagligt med en middel-behandlingsvarighed på 96 uger, havde 48% grad 3-4 forhøjelse af total bilirubin (se pkt.
Among naive patients treated with REYATAZ 300 mg once daily with 100 mg ritonavir once daily for a median duration of 96 weeks, 48% had Grade 3-4 total bilirubin elevations (see section 4.4).
Quinidin har et snævert terapeutisk indeks og er kontraindiceret pga. risiko for CYP3Ahæmning med REYATAZ.
Quinidine has a narrow therapeutic window and is contraindicated due to potential inhibition of CYP3A by REYATAZ.
Simvastatin og lovastatin metaboliseres i høj grad via CYP3A4 og samtidig administration med REYATAZ kan medføre øgede koncentrationer.
Simvastatin and lovastatin are highly dependent on CYP3A4 for their metabolism and co-administration with REYATAZ may result in increased concentrations.
100 to <200 celler/mm3
100 to <200 cells/mm3
Lamotrigin bør anvendes med forsigtighed sammen med REYATAZ/ritonavir.
Lamotrigine should be used with caution in combination with REYATAZ/ritonavir.
Sammenlignet med atazanavir 300 mg med ritonavir 100 mg uden tenofovir forventes koncentrationen af atazanavir at falde yderligere med ca.
When compared to atazanavir 300 mg with ritonavir 100 mg without tenofovir, atazanavir concentrations are expected to be additionally decreased by about 20%.
Den anbefalede dosis til voksne er 300 mg én gang dagligt sammen med 100 mg ritonavir én gang dagligt i forbindelse med et måltid og i kombination med anden hiv-medicin.
The recommended adult dose of REYATAZ capsules is 300 mg once daily with 100 mg ritonavir once daily and with food, in combination with other anti-HIV medicines.
REYATAZ 50 mg oralt pulver atazanavir
REYATAZ 50 mg oral powder atazanavir
LÆGEMIDDELFORM OG ANTAL (PAKNINGSSTØRRELSE) Æske til beholderpakning (1 beholder): 30 hårde kapsler Æske til beholderpakning: (3 beholdere): 3 x 30 hårde kapsler (3 beholdere med 30 hårde kapsler) Etiket til beholderpakning: 30 hårde kapsler
Carton Bottle pack (1 bottle): 30 hard capsules Carton Bottle pack: (3 bottles): 3 x 30 hard capsules (3 bottles of 30 hard capsules) Label Bottle pack: 30 hard capsules
Methadon, stabil vedligeholdelsesdosis (atazanavir 400 mg 1 gang dagligt)
Methadone, stable maintenance dose (atazanavir 400 mg once daily)
Graviditet:
Pregnancy:
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 (se pkt.
Stevens-Johnson syndrome (SJS), erythema multiforme, toxic skin eruptions and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been reported with the use of REYATAZ (see section 4.4).
Patienterne skal monitoreres tæt for tenofovirdisoproxilrelaterede bivirkninger, inklusive nyrefunktionspåvirkning.
Patients should be closely monitored for tenofovir disoproxil-associated adverse reactions, including renal disorders.
Plasmakoncentrationen af atazanavir kan falde, hvis gastrisk pH øges ved samtidig administration af antacida, inklusive lægemidler med buffer, og REATAZ/ritonavir.
Reduced plasma concentrations of atazanavir may be the consequence of increased gastric pH if antacids, including buffered medicinal products, are administered with REYATAZ/ritonavir.
a Intent-to-treat-analyse hvor manglende værdier betragtes som behandlingssvigt.
a Intent-to-treat analysis, with missing values considered as failures.
Pædiatriske patienter fra 3 måneder til under 18 år, som fik enten oralt pulver eller kapsler, havde i et klinisk studie AI424-020 en gennemsnitlig behandlingsvarighed med REYATAZ på 115 uger.
In a clinical study AI424-020, paediatric patients 3 months to less than 18 years of age who received either the oral powder or capsule formulation had a mean duration of treatment with REYATAZ of 115 weeks.
Samtidig administration af REYATAZ/ritonavir og quetiapin er kontraindiceret, da REYATAZ kan øge quetiapinrelateret toksicitet.
Co-administration of REYATAZ/ritonavir with quetiapine is contraindicated as may increase quetiapine-related toxicity.
I tabel 7 ses data for virkningen hos de 41 pædiatriske patienter i alderen fra 6 år til under 18 år, som fik REYATAZ-kapsler med ritonavir.
Efficacy data observed in the 41 paediatric patients aged 6 years to less than 18 years that received REYATAZ capsules with ritonavir are presented in Table 7.
Fenylketonuri
Phenylketonuria
REYATAZ-kapsler skal tages sammen med ritonavir og i forbindelse med et måltid.
REYATAZ capsules must be taken with ritonavir and have to be taken with food.
Samtidig administration med produkter indeholdende grazoprevir, inklusive fastdosis‑kombination af elbasvir/grazoprevir (se pkt.
Co-administration with grazoprevir-containing products, including elbasvir/grazoprevir fixed dose combination (see section 4.5).
Didanosin (med mad) Didanosin AUC ↓34% (↓41% ↓27%) Didanosin Cmax ↓38% (↓48% ↓26%) Didanosin Cmin ↑25% (↓8% ↑69%)
Didanosine (with food) Didanosine AUC ↓34% (↓41% ↓27%) Didanosine Cmax ↓38% (↓48% ↓26%) Didanosine Cmin ↑25% (↓8% ↑69%)
G Selekterede substitutioner inkluderer alle ændringer ved position L10, K20, L24, V32, L33, M36, M46, G48, I50, I54, L63,
g Select substitutions include any change at positions L10, K20, L24, V32, L33, M36, M46, G48, I50, I54, L63, A71, G73, V82, I84, and L90 (0-2, 3, 4 or more) at baseline.
14-OH-clarithromycin 14-OH-clarithromycin AUC ↓70%
14-OH clarithromycin 14-OH clarithromycin AUC ↓70% 14-OH clarithromycin Cmax ↓72% 14-OH clarithromycin Cmin ↓62%
Patienter, der ikke tager tenofovir, hvis REYATAZ 300 mg/ritonavir 100 mg og H2receptorantagonister administreres samtidigt, bør en dosis svarende til famotidin 20 mg 2 gange dagligt ikke overskrides.
For patients not taking tenofovir, if REYATAZ 300 mg/ritonavir 100 mg and H2-receptor antagonists are coadministered, a dose equivalent to famotidine 20 mg twice daily should not be exceeded.
Hjælpestof, som behandleren skal være opmærksom på: 109,57 mg lactose per kapsel.
Excipient with known effect: 109.57 mg of lactose per capsule.
På grund af carbamazepins inducerende effekt kan nedsat eksponering for REYATAZ ikke udelukkes.
Due to carbamazepine inducing effect, a reduction in REYATAZ exposure cannot be ruled out.
b Hvert brev indeholder 50 mg atazanavir.
b Each sachet contains 50 mg of atazanavir.
Tilsæt mindst en spiseskefuld mad og rør rundt.
Add a minimum of one tablespoon of food and mix.
Du kan også anvende en større mængde modermælkserstatning, væske eller mad.
Larger volumes or quantities of liquid infant formula, beverage or food may be used.
Hiv-smittede patienter, der tager en øget dosis atazanavir/ritonavir på 400/100 mg 1 gang dagligt
In HIV-infected patients with atazanavir/ritonavir at an increased dose of 400/100 mg once daily
På grund af carbamazepins inducerende effekt kan nedsat eksponering for REYATAZ/ritonavir ikke udelukkes.
Due to carbamazepine inducing effect, a reduction in REYATAZ/ritonavir exposure cannot be ruled out.
Blandt behandlingserfarne patienter som fik REYATAZ 300 mg én gang dagligt med 100 mg ritonavir én gang dagligt i gennemsnitligt 95 uger, havde 53% grad 3-4 forhøjelse af total bilirubin.
Among experienced patients treated with REYATAZ 300 mg once daily with 100 mg ritonavir once daily for a median duration of 95 weeks, 53% had Grade 3-4 total bilirubin elevations.
80 mgc mindst 15 til under 35
80 mgc at least 15 to less than 35
Samtidig brug af perikon og REYATAZ/ritonavir kan forventes at medføre signifikant fald i atazanavirs plasmaniveau.
Concomitant use of St. John's wort with REYATAZ/ritonavir may be expected to result in significant reduction in plasma levels of atazanavir.
Se indlægsseddel for yderligere information 4.
See leaflet for further information
De samme anbefalinger for lægemiddelinteraktioner gælder med undtagelse af: at administration sammen med tenofovir, boceprevir, carbamazepin, phenytoin, phenobarbital, protonpumpehæmmere og buprenorphin frarådes.
In case of withdrawal of ritonavir from the recommended atazanavir boosted regimen (see section 4.4) The same recommendations for drug drug interactions would apply except: that co-administration is not recommended with tenofovir, boceprevir, carbamazepine, phenytoin, phenobarbital, proton pump inhibitors, and buprenorphine.
Tilsæt 10 ml tilberedt modermælkserstatning og rør rundt med en ske.
Add 10 ml of prepared liquid infant formula and mix using a spoon.
REYATAZ forventes at øge plasmakoncentrationen af lurasidon på grund af CYP3A4-hæmning.
REYATAZ is expected to increase plasma levels of lurasidone due to CYP3A4 inhibition.
Absorption: gentagne doser af REYATAZ 300 mg én gang dagligt i kombination med ritonavir 100 mg én gang dagligt sammen med et måltid gav hos hiv-inficerede patienter (n=33, kombinerede studier) et geometrisk gennemsnit (CV%) for atazanavir, Cmax på 4.466 (42%) ng/ml, med en tid til Cmax på ca. 2,5 timer.
Absorption: in HIV-infected patients (n=33, combined studies), multiple dosing of REYATAZ 300 mg once daily with ritonavir 100 mg once daily with food produced a geometric mean (CV%) for atazanavir, Cmax of 4466 (42%) ng/ml, with time to Cmax of approximately 2.5 hours.
Yderligere 15 ml væske hældes i drikkekoppen for at skylle koppen.
An additional 15 ml of beverage is added to the drinking cup for thorough rinsing of the cup and contents are mixed.
Raltegravir 400 mg 2 gange dagligt (atazanavir/ritonavir)
Integrase Inhibitors Raltegravir 400 mg twice daily (atazanavir/ritonavir)
Atazanavir, samtidig administration af ddI+d4T (fastende) Atazanavir AUC ↓87% (↓92% ↓79%) Atazanavir Cmax ↓89% (↓94% ↓82%) Atazanavir Cmin ↓84% (↓90% ↓73%)
Atazanavir, simultaneous administration with ddI+d4T (fasted) Atazanavir AUC ↓87% (↓92% ↓79%) Atazanavir Cmax ↓89% (↓94% ↓82%) Atazanavir Cmin ↓84% (↓90% ↓73%)
Hver kapsel af REYATAZ 300 mg indeholder 300 mg atazanavir.
Each capsule of REYATAZ 300 mg contains 300 mg atazanavir.
Nedsat leverfunktion: Atazanavir metaboliseres primært via leveren, og der er observeret forhøjet plasmakoncentration hos patienter med nedsat leverfunktion (se pkt.
Hepatic impairment: Atazanavir is primarily hepatically metabolised and increased plasma concentrations were observed in patients with hepatic impairment (see sections 4.2 and 4.3).
Der er anden medicin, som du ikke må tage samtidig med REYATAZ.
There are other medicines that may not mix with REYATAZ.
Samtidig administration af REYATAZ/ritonavir og andre hormonelle kontraceptionsmidler eller orale kontraceptionsmidler indeholdende andre gestagener end norgestimat er ikke blevet undersøgt og bør derfor undgås.
Co-administration of REYATAZ/ritonavir with other hormonal contraceptives or oral contraceptives containing progestogens other than norgestimate has not been studied, and therefore should be avoided.
Samtidig brug af perikon og REYATAZ kan forventes at medføre signifikant fald i atazanavirs plasmaniveau.
Concomitant use of St. John's wort with REYATAZ may be expected to result in significant reduction in plasma levels of atazanavir.
Samtidig administration af voriconazol og REYATAZ med ritonavir frarådes, medmindre det vurderes, at fordel/risiko-forholdet berettiger brugen af voriconazol.
Co-administration of voriconazole and REYATAZ with ritonavir is not recommended, unless an assessment of the benefit/risk justifies the use of voriconazole.
Raltegravir AUC ↑41% Raltegravir Cmax ↑24% Raltegravir C12t ↑77%
Raltegravir AUC ↑41% Raltegravir Cmax ↑24% Raltegravir C12hr ↑77% The mechanism is UGT1A1 inhibition.
Hvid trykfarve indeholdende: shellac, titandioxid (E171), ammoniumhydroxid, propylenglycol og simeticon
White ink containing: shellac, titanium dioxide (E171), ammonium hydroxide, propylene glycol and simethicone
hiv-RNA <50 kopier/ml, % Alle patienterd Afvigelsesestimat
HIV RNA <50 copies/ml, % All patientsd
Ethinylestradiol 35 µg + norethindron (atazanavir 400 mg 1 gang dagligt)
Ethinyloestradiol 35 µg + norethindrone (atazanavir 400 mg once daily)
Efter en 26-30 ugers induktionsfase med REYATAZ 300 mg + ritonavir 100 mg én gang dagligt og to NRTI'er havde ikke-boostet REYATAZ 400 mg én gang dagligt og to NRTI'er, som blev administreret i en 48-ugers vedligeholdelsesfase (n=87) i et åbent, randomiseret, komparativt studie, samme antivirale virkning som REYATAZ + ritonavir og to NRTI'er (n=85) hos hiv-inficerede forsøgspersoner med fuldt supprimeret hiv-replikation.
In an open-label, randomised, comparative study following a 26- to 30-week induction phase with REYATAZ 300 mg + ritonavir 100 mg once daily and two NRTIs, unboosted REYATAZ 400 mg once daily and two NRTIs administered during a 48-week maintenance phase (n=87) had similar antiviral efficacy compared with REYATAZ + ritonavir and two NRTIs (n=85) in HIV infected subjects with fully suppressed HIV replication, as assessed by the proportion of subjects with HIV RNA < 50 copies/ml: 78% of subjects on unboosted REYATAZ and two NRTIs compared with 75% on REYATAZ + ritonavir and two NRTIs.
Samtidig administration af REYATAZ/ritonavir og disse glukokortikoider frarådes, medmindre den potentielle fordel ved behandlingen opvejer risikoen for systemiske bivirkninger (se pkt.
Co-administration of REYATAZ/ritonavir and these glucocorticoids is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.4).
Hjælpestof, som behandleren skal være opmærksom på: 54,79 mg lactose per kapsel.
Excipient with known effect: 54.79 mg of lactose per capsule.
Der kan anvendes en større mængde modermælkserstatning, væske eller føde til doseringen.
Larger volumes or quantities of liquid infant formula, beverage or food may be used for dosing.
Plasmakoncentrationen af atazanavir kan falde, hvis gastrisk pH øges ved samtidig administration af antacida, inklusive lægemidler med buffer, og REATAZ.
Reduced plasma concentrations of atazanavir may be the consequence of increased gastric pH if antacids, including buffered medicinal products, are administered with REYATAZ.
Samtidig administration af abacavir og REYATAZ forventes ikke at påvirke abacavirs eksponering signifikant.
The co-administration of abacavir and REYATAZ is not expected to significantly alter the exposure of abacavir.
15 til under 35
15 to less than 35
b Antal evaluérbare patienter c PI major L24I, D30N, V32I, L33F, M46IL, I47AV, G48V, I50LV, F53LY, I54ALMSTV, L76V, V82AFLST, I84V, N88DS, L90M; PI minor: L10CFIRV, V11I, E35G, K43T, Q58E, A71ILTV, G73ACST, T74P, N83D, L89V.
c PI major L24I, D30N, V32I, L33F, M46IL, I47AV, G48V, I50LV, F53LY,I54ALMSTV, L76V, V82AFLST, I84V, N88DS, L90M; PI minor: L10CFIRV, V11I, E35G, K43T, Q58E, A71ILTV, G73ACST, T74P, N83D, L89V.
Interaktionsmekanismen er nedsat opløselighed af atazanavir pga. en stigning i pH, der skyldes det syrehæmmende middel i didanosintabletterne med buffer.
The mechanism of interaction is a reduced solubility of atazanavir with increasing pH related to the presence of anti-acid agent in didanosine buffered tablets.
LÆGEMIDDELFORM OG ANTAL (PAKNINGSSTØRRELSE) Æske til beholderpakning (1 beholder): 60 hårde kapsler Æske til beholderpakning: (3 beholdere): 3 x 60 hårde kapsler (3 beholdere med 60 hårde kapsler) Etiket til beholderpakning: 60 hårde kapsler
Carton Bottle pack (1 bottle): 60 hard capsules Carton Bottle pack: (3 bottles): 3 x 60 hard capsules (3 bottles of 60 hard capsules) Label Bottle pack: 60 hard capsules
PULMONAL ARTERIEL HYPERTENSION
PULMONARY ARTERIAL HYPERTENSION PDE5 Inhibitors
Samtidig brug af salmeterol og REYATAZ/ritonavir kan resultere i en øget risiko for salmeterolrelaterede kardiovaskulære bivirkninger.
Concomitant use of salmeterol and REYATAZ/ritonavir may result in increased cardiovascular adverse events associated with salmeterol.
LPV/RTVc (400 mg/ 100 mg to gange dagligt) n=123
LPV/RTVc (400 mg/ 100 mg twice daily) n=123
Den geometriske middeleksponering for atazanavir (Cmin, Cmax og AUC ) ved den anbefalede dosering forventes imidlertid at være den samme hos pædiatriske patienter, som er observeret hos voksne.
As a result, greater peak to trough ratios are observed, however at recommended doses, geometric mean atazanavir exposures (Cmin, Cmax and AUC) in paediatric patients are expected to be similar to those observed in adults.
Dosisjustering er ikke nødvendig ved samtidig administration af methadon og REYATAZ og ritonavir.
No dosage adjustment is necessary if methadone is coadministered with REYATAZ and ritonavir.
Carbamazepin bør anvendes med forsigtighed sammen med REYATAZ/ritonavir.
Carbamazepine should be used with caution in combination with REYATAZ/ritonavir.
ATV/RTVb (300 mg/ 100 mg én gang dagligt) n=120
ATV/RTVb (300 mg/ 100 mg once daily) n=120
Tenofovirdisoproxilfumarat AUC Tenofovirdisoproxilfumarat Cmax Tenofovirdisoproxilfumarat Cmin ↑29%
Tenofovir disoproxil fumarate AUC Tenofovir disoproxil fumarate Cmax Tenofovir disoproxil fumarate Cmin
Samtidig administration af REYATAZ med ritonavir og en protonpumpehæmmer frarådes.
Co-administration of REYATAZ with ritonavir and proton pump inhibitors is not recommended.
Hvert brev med REYATAZ oralt pulver indeholder 50 mg atazanavir.
Each sachet of REYATAZ 50 mg oral powder contains 50 mg atazanavir.
REYATAZ/ritonavir kan øge plasmakoncentrationen af carbamazepin på grund af CYP3A4hæmning.
REYATAZ/ritonavir may increase plasma levels of carbamazepine due to CYP3A4 inhibition.
Samtidig administration af kombination af rifampicin og REYATAZ med lavdosis ritonavir er kontraindiceret (se pkt.
The combination of rifampicin and REYATAZ with concomitant low-dose ritonavir is contraindicated (see section 4.3).
Patienter, der tager tenofovirdisoproxilfumarat, hvis REYATAZ/ritonavir administreres samtidigt med både tenofovirdisoproxil og en H2-receptorantagonist, anbefales dosisøgning af REYATAZ til 400 mg med 100 mg ritonavir.
For patients who are taking tenofovir disoproxil fumarate, if REYATAZ/ritonavir with both tenofovir disoproxil and an H2-receptor antagonist are coadministered,a dose increase of REYATAZ to 400 mg with 100 mg of ritonavir is recommended.
Bør ikke anvendes af patienter med hereditær fructoseintolerans, glucose/galactosemalabsorption eller sucroseisomaltasemangel.
Patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucrase isomaltase insufficiency should not take this medicine.
Voriconazol AUC ↓33% (↓42% ↓22%) Voriconazol Cmax ↓10% (↓22% ↓4%) Voriconazol Cmin ↓39% (↓49% ↓28%)
Voriconazole AUC ↓33% (↓42% Voriconazole Cmax ↓10% (↓22% ↓4%) Voriconazole Cmin ↓39% (↓49% ↓28%)
REYATAZ uden ritonavir bør ikke overvejes hos patienter, der bliver behandlet i et baggrundsprogram med tenofovirdisoproxil og med andre samtidige lægemidler, der reducerer atazanavirs biotilgængelighed (se pkt.
REYATAZ given without ritonavir should not be considered in patients treated with a backbone regimen containing tenofovir disoproxil and with other concomitant medications that reduce atazanavir bioavailability (see section 4.5 In case of withdrawal of ritonavir from the recommended atazanavir boosted regimen) or in case of perceived challenging compliance.
Samtidig administration af REYATAZ og nevirapin eller efavirenz frarådes (se pkt.
Co-administration of REYATAZ with nevirapine or efavirenz is not recommended (see section 4.5).
Pibrentasvir Cmax: ↑29% (↑15% ↑45%) Pibrentasvir Cmin: ↑129% (↑95%
Pibrentasvir AUC : ↑64% (↑48% Pibrentasvir Cmax : ↑29% (↑15% ↑45%) Pibrentasvir Cmin: ↑129% (↑95%
80 mgc mindst 35
80 mgc at least 35
Diltiazem Cmax ↑98% (↑78% ↑119%) Diltiazem Cmin ↑142% (↑114%
Diltiazem AUC ↑125% (↑109% Diltiazem Cmax ↑98% (↑78% ↑119%) Diltiazem Cmin ↑142% (↑114%
Hiv-smittede patienter, der tager den anbefalede dosis atazanavir/ritonavir på 300/100 mg 1 gang dagligt
In HIV-infected patients with atazanavir/ritonavir at the recommended dose 300/100 mg once daily
Behandlingsnaive REYATAZkapsler/ritonavir (300 mg/100 mg én gang dagligt) n=16
Treatment-Naive REYATAZ Capsules/ritonavir (300 mg/100 mg once daily) n=16
ikke almindelig: nefrolitiasisa, hæmaturi, proteinuri, pollakisuri, interstitiel nefritis, kronisk nyresygdoma; sjælden: nyresmerter
uncommon: nephrolithiasisa, haematuria, proteinuria, pollakiuria, interstitial nephritis, chronic kidney diseasea; rare: kidney pain
Studie 138 er et internationalt, randomiseret, åbent, prospektivt multicenter-studie med 883 ikke tidligere antiretroviralt behandlede patienter, der sammenligner REYATAZ/ritonavir (300 mg/100 mg én gang dagligt) med lopinavir/ritonavir (400 mg/100 mg 2 gange dagligt), hver i kombination med en fast dosis tenofovirdisoproxilfumarat/emtricitabin (300 mg/200 mg tabletter én gang dagligt).
Study 138 is an international randomised, open-label, multicenter, prospective trial of 883 antiretroviral treatment naive patients comparing REYATAZ/ritonavir (300 mg/100 mg once daily) to lopinavir/ritonavir (400 mg/100 mg twice daily), each in combination with fixed dose tenofovir disoproxil fumarate/emtricitabine (300 mg/200 mg tablets once daily).
Sildenafil er kontraindiceret ved behandling af pulmonal arteriel hypertension (se pkt.
Sildenafil, when used for the treatment of pulmonary arterial hypertension, is contraindicated (see section 4.3).
Fås i en æske med enten en eller tre beholdere med 60 hårde kapsler.
Either one or three bottles of 60 hard capsules are provided in one carton.
REYATAZ/ritonavir bør ikke administreres sammen med triazolam eller oralt administreret midazolam (se pkt.
REYATAZ/ritonavir should not be co-administered with triazolam or orally administered midazolam (see section 4.3), whereas caution should be used with co-administration of REYATAZ/ritonavir and parenteral midazolam.