natgillin/translations-raw huggingface dataset:
REYATAZ bør anvendes med forsigtighed til pædiatriske patienter med allerede eksisterende overledningsproblemer (andengrads- eller højere atrioventrikulær eller kompleks knude-grenblok), og kun såfremt fordelene opvejer risikoen.
In paediatric patients with pre-existing conduction problems (second degree or higher atrioventricular or complex bundle-branch block), REYATAZ should be used with caution and only if the benefits exceed the risk.
Koncentration af disse immunsuppressiva kan øges ved samtidig administration af REYATAZ pga. CYP3A4-hæmning.
Concentrations of these immunosuppressants may be increased when co-administered with REYATAZ due to CYP3A4 inhibition.
Der er rapporteret om cholelithiasis hos patienter behandlet med REYATAZ (se pkt.
Cholelithiasis has been reported in patients receiving REYATAZ (see section 4.8).
Samtidig administration af REYATAZ/ritonavir og alfuzosin er kontraindiceret (se pkt.
Co-administration of REYATAZ/ritonavir with alfuzosin is contraindicated (see section 4.3)
Hvis det er nødvendigt at anvende tenofovirdisoproxil eller en H2-receptorantagonist, bør det overvejes at øge dosis af REYATAZ til 400 mg med 100 mg ritonavir under TDM (se pkt.
If tenofovir disoproxil or an H2-receptor antagonist is needed, a dose increase to REYATAZ 400 mg with ritonavir 100 mg with TDM may be considered (see sections 4.6 and 5.2).
Samtidig administration af REYATAZ/ritonavir og abacavir forventes ikke at påvirke abacavirs eksponering signifikant.
The co-administration of REYATAZ/ ritonavir with abacavir is not expected to significantly alter the exposure of abacavir.
4.4) kan ikke-boostet REYATAZ fortsættes hos patienter med let nedsat leverfunktion med en dosis på 400 mg og hos patienter med moderat nedsat leverfunktion med en reduceret dosis på 300 mg en gang dagligt sammen med føde (se pkt.
In case of withdrawal of ritonavir from the initial recommended ritonavir boosted regimen (see section 4.4), unboosted REYATAZ could be maintained in patients with mild hepatic impairment at a dose of 400 mg, and in patients with moderate hepatic impairment with a reduced dose of 300 mg once daily with food (see section 5.2).
Buprenorphin, 1 gang dagligt, stabil vedligeholdelsesdosis (atazanavir 300 mg 1 gang dagligt med ritonavir 100 mg 1 gang dagligt)
Buprenorphine, once daily, stable maintenance dose (atazanavir 300 mg once daily with ritonavir 100 mg once daily)
REYATAZ må ikke anvendes til patienter med svært nedsat leverfunktion.
Unboosted REYATAZ must not be used in patients with severe hepatic impairment.
Tilberedning og indgivelse af medicinen sammen med væske
Preparing and giving the medicine with drinks
Nyresten kan forekomme mindre hyppigt hos personer, der tager REYATAZ.
Kidney stones uncommonly happen in people taking REYATAZ.
C: Blanding af det anviste antal breve REYATAZ oralt pulver med føde som f.eks. æblemos eller yoghurt i en lille beholder:
C: To mix the recommended number of REYATAZ oral powder sachets with food such as applesauce or yogurt in a small container: One tablespoon of food is used to mix the content of the sachets.
Doseringen af atazanavir-kapsler til pædiatriske patienter bestemmes ud fra legemsvægten som vist i tabel 1 og bør ikke overskride den anbefalede dosis for voksne.
Paediatric patients (6 years to less than 18 years of age and weighing at least 15 kg) The dose of atazanavir capsules for paediatric patients is based on body weight as shown in Table 1 and should not exceed the recommended adult dose.
REYATAZ bør anvendes med forsigtighed til patienter med allerede eksisterende overledningsproblemer (andengrads- eller højere atrioventrikulær eller kompleks knude-grenblok), og kun såfremt fordelene opvejer risikoen (se pkt.
In patients with pre-existing conduction problems (second degree or higher atrioventricular or complex bundle-branch block), REYATAZ should be used with caution and only if the benefits exceed the risk (see section 5.1).
Samtidig brug af salmeterol og REYATAZ kan resultere i en øget risiko for salmeterol-relaterede kardiovaskulære bivirkninger.
Concomitant use of salmeterol and REYATAZ may result in increased cardiovascular adverse events associated with salmeterol.
Samtidig administration af REYATAZ og andre hormonelle kontraceptionsmidler eller orale kontraceptionsmidler indeholdende andre gestagener end norgestimat eller norethindron er ikke blevet undersøgt og bør derfor undgås (se pkt.
Co-administration of REYATAZ with other hormonal contraceptives or oral contraceptives containing progestogens other than norgestimate or norethindrone has not been studied, and therefore should be avoided (see section 4.5).
Hæld indholdet af brevene i en medicinkop eller lille beholder.
Take a medicine cup or small container and put the sachets' content in the cup or small container.
mm3), og middel-baseline-plasma-hiv-1-RNA var 4,09 log10 kopier/ml (interval: 3,285,00 log10 kopier/ml).
3) and mean baseline plasma HIV-1 RNA was 4.09 log10 copies/ml (range: 3.28 to 5.00 log10 copies/ml).
almindelig: udslæt ikke almindelig: erythema multiformea,b, toksiske huderuptionera,b, lægemiddelfremkaldt udslæt med eosinofili og systemiske symptomer (DRESS-syndrom)a,b,
common: rash; uncommon: erythemia multiformea,b, toxic skin eruptionsa,b, drug rash with eosinophilia and systemic symptoms (DRESS) syndromea,b, angioedemaa, urticaria, alopecia, pruritus; rare: Stevens-Johnson syndromea,b, vesiculobullous rash, eczema, vasodilatation
Studie 138 er et internationalt, randomiseret, åbent, prospektivt multicenter-studie med 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 treatment naïve 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).
Clarithromycin 500 mg 2 gange dagligt (atazanavir 400 mg 1 gang dagligt)
ANTIBIOTICS Clarithromycin 500 mg twice daily (atazanavir 400 mg once daily)
Koncentration af disse immunsuppressiva kan øges ved samtidig administration af REYATAZ/ritonavir pga. CYP3A4hæmning.
Concentrations of these immunosuppressants may be increased when co-administered with REYATAZ/ritonavir due to CYP3A4 inhibition.
Tabel 1: Dosis af REYATAZ-kapsler med ritonavir til pædiatriske patienter (fra 6 år til under 18 år og med en legemsvægt på mindst 15 kg) Legemsvægt (kg)
Table 1: Dose for paediatric patients (6 years to less than 18 years of age and weighing at least 15 kg) for REYATAZ capsules with ritonavir Body Weight (kg)
Samtidig administration af REYATAZ/ritonavir og en protonpumpehæmmer frarådes.
Co-administration of REYATAZ/ritonavir with proton pump inhibitors is not recommended.
REYATAZ kan øge plasmakoncentrationen af carbamazepin på grund af CYP3A4hæmning.
REYATAZ may increase plasma levels of carbamazepine due to CYP3A4 inhibition.
Kapslens indhold: crospovidon, lactosemonohydrat og magnesiumstearat Kapslens skal: gelatine, indigocarmin (E132) og titandioxid (E171) Blåt blæk indeholdende: shellac, propylenglycol, ammoniumhydroxid og indigocarmin (E132) Hvid trykfarve indeholdende: shellac, titandioxid (E171), ammoniumhydroxid, propylenglycol og simeticon
Capsule contents: crospovidone, lactose monohydrate and magnesium stearate Capsule shells: gelatine, indigocarmin (E132) and titanium dioxide (E171) Blue ink containing: shellac, propylene glycol, ammonium hydroxide and indigocarmin (E132) White ink containing: shellac, titanium dioxide (E171), ammonium hydroxide, propylene glycol and simethicone
Administration sammen med REYATAZ/ritonavir kan medføre øget koncentration af PDE5-hæmmeren og øget risiko for PDE5-hæmmerrelaterede bivirkninger.
Co-administration with REYATAZ/ritonavir may result in increased concentrations of the PDE5 inhibitor and an increase in PDE5inhibitor-associated adverse events.
Gulsot er forekommet hos patienter, som tager REYATAZ.
Kidney stones have been reported in patients taking REYATAZ.
Hyppighed de novo PI substitution (n=35)a,b M36, M46, I54, A71, V82 L10, I15, K20, V32, E35, S37, F53, I62, G73, I84, L90
De novo substitutions in treatment experienced patients failing therapy with atazanavir + ritonavir (Study 045, 48 weeks) Frequency de novo PI substitution (n=35)a,b M36, M46, I54, A71, V82 L10, I15, K20, V32, E35, S37, F53, I62, G73, I84, L90
Norgestimat Cmax ↑68% (↑51% ↑88%) Norgestimat Cmin ↑102% (↑77%
Norgestimate AUC ↑85% (↑67% Norgestimate Cmax ↑68% (↑51% Norgestimate Cmin ↑102% (↑77%
Serumkoncentrationen af verapamil kan øges af REYATAZ pga. CYP3A4hæmning.
Serum concentrations of verapamil may be increased by REYATAZ due to CYP3A4 inhibition.
Tabel 1: Dosis af REYATAZ oralt pulver med ritonavir til pædiatriske patientera (mindst
Table 1: Dose of REYATAZ oral powder with ritonavir for paediatric patientsa (at least 3 months of age and weighing at least 5 kg)
Samtidig administration af REYATAZ/ritonavir kan medføre øget koncentration af PDE5-hæmmeren og øget risiko for PDE5-relaterede bivirkninger, inklusive hypotension, synsforstyrrelser og priapisme.
REYATAZ/ritonavir may result in increased concentrations of the PDE5 inhibitor and an increase in PDE5associated adverse events, including hypotension, visual changes, and priapism.
REYATAZ 150 mg hårde kapsler
REYATAZ 150 mg hard capsules
REYATAZ/ritonavirb (300 mg/100 mg én gang dagligt) n=440
REYATAZ/ritonavirb (300 mg/100 mg once daily) n=440
Der anvendes en ske til at blande indholdet af det pågældende antal breve (4 eller 5 breve afhængigt at spædbarnets vægt) med 10 ml tilberedt modermælkserstatning i medicinkoppen eller den lille beholder.
A: To mix the recommended number of REYATAZ oral powder sachets with liquid infant formula in a small medicine cup or small container and to administer with an oral syringe, which can be obtained from a pharmacist: A spoon is used to mix the content of the appropriate number of sachets (4 or 5 sachets depending on infant weight) with 10 ml of prepared liquid infant formula in the medicine cup or small container.
Samtidig administration af REYATAZ kan medføre højere salmeterolkoncentration og øget risiko for salmeterol-relaterede bivirkninger.
Co-administration with REYATAZ may result in increased concentrations of salmeterol and an increase in salmeterol-associated adverse events.
Administration sammen med REYATAZ kan medføre øget koncentration af PDE5-hæmmeren og øget risiko for PDE5-hæmmerrelaterede bivirkninger.
Co-administration with REYATAZ may result in increased concentrations of the PDE5 inhibitor and an increase in PDE5-inhibitor-associated adverse events.
Samtidig administration af REYATAZ med produkter indeholdende grazoprevir inklusive elbasvir/grazoprevir i fastdosis-kombination er kontraindiceret på grund af stigning i plasmakoncentrationerne af grazoprevir og elbasvir og den potentielle stigning i risiko for ALAT-stigning som er associeret med stigning i koncentrationer af grazoprevir (se pkt.
Co-administration of REYATAZ with grazoprevir-containing products, including elbasvir/grazoprevir fixed dose combination is contraindicated because of the increase in grazoprevir and elbasvir plasma concentrations and potential for the increase in risk of ALT elevations associated with increased grazoprevir concentrations (see section 4.3).
Ingen a Antal patienter med parvise genotyper, der er klassificeret som virologisk svigt (hiv-RNA ≥ 400 kopier/ml).
Frequency de novo PI substitution (n=26)a none none a Number of patients with paired genotypes classified as virological failures (HIV RNA ≥ 400 copies/ml).
Tilsæt 30 ml væske og rør rundt med en ske.
Add 30 ml of the drink and mix with a spoon.
Ketoconazol og itraconazol bør anvendes med forsigtighed sammen med
Ketoconazole and itraconazole should be used cautiously with REYATAZ/ritonavir.
Ethinylestradiol 25 μg + norgestimat (atazanavir 300 mg 1 gang dagligt med ritonavir 100 mg 1 gang dagligt)
HORMONAL CONTRACEPTIVES Ethinyloestradiol 25 μg + norgestimate (atazanavir 300 mg once daily with ritonavir 100 mg once daily)
Lopinavir/ritonavirc (400 mg/100 mg 2 gange dagligt) n=443
Lopinavir/ritonavirc (400 mg/100 mg twice daily) n=443
Samtidig administration af REYATAZ kan medføre øget koncentration af PDE5hæmmeren og øget risiko for PDE5relaterede bivirkninger, inklusive hypotension, synsforstyrrelser og priapisme.
Coadministration with REYATAZ may result in increased concentrations of the PDE5 inhibitor and an increase in PDE5-associated adverse events, including hypotension, visual changes, and priapism.
Behandlingserfarne REYATAZkapsler/ritonavir (300 mg/100 mg én gang dagligt) n=25
TreatmentExperienced REYATAZ Capsules/ritonavir (300 mg/100 mg once daily) n=25
250 mg (5 breveb)
250 mg (5 sachetsb)
B: Blanding af det anviste antal breve REYATAZ oralt pulver med væske som f.eks. mælk eller vand i en lille drikkekop:
B: To mix the recommended number of REYATAZ oral powder sachets with a beverage such as milk or water in a small drinking cup: A spoon is used to mix the content of the sachets with 30 ml of the beverage.
25-O-desacetyl-rifabutin AUC ↑990%
Total rifabutin and 25-O-desacetyl-rifabutin AUC ↑119% (↑78% ↑169%).
Sofosbuvir 400 mg / velpatasvir 100 mg /voxilaprevir 100 mg enkeltdosis* (atazanavir 300 mg / ritonavir 100 mg 1 gang dagligt)
Sofosbuvir 400 mg / velpatasvir 100 mg / voxilaprevir 100 mg single dose* (atazanavir 300 mg / ritonavir 100 mg once daily)
Sofosbuvir 400 mg / velpatasvir 100 mg / voxilaprevir 100 mg enkeltdosis* (atazanavir 300 mg / ritonavir 100 mg 1 gang dagligt)
Sofosbuvir 400 mg / velpatasvir 100 mg /voxilaprevir 100 mg single dose* (atazanavir 300 mg / ritonavir 100 mg once daily)
Samtidig administration af REYATAZ/ritonavir kan medføre højere salmeterol-koncentration og øget risiko for salmeterol-relaterede bivirkninger.
Co-administration with REYATAZ/ritonavir may result in increased concentrations of salmeterol and an increase in salmeterolassociated adverse events.
Kapslens indhold: crospovidon, lactosemonohydrat og magnesiumstearat Kapslens skal: gelatine, indigocarmin (E132) og titandioxid (E171) Hvid trykfarve indeholdende: shellac, titandioxid (E171), ammoniumhydroxid, propylenglycol og simeticon
Capsule contents: crospovidone, lactose monohydrate and magnesium stearate Capsule shells: gelatine, indigocarmin (E132) and titanium dioxide (E171) White ink containing: shellac, titanium dioxide (E171), ammonium hydroxide, propylene glycol and simethicone
Kapselskallen og tryksværte indeholder gelatine, shellac, ammoniumhydroxid, simeticon, rød jernoxid, sort jernoxid, gul jernoxid, propylenglycol, indigocarmin (E132) og titandioxid (E171).
The capsule shell and printing ink contain gelatine, shellac, ammonium hydroxide, simethicone, red iron oxide, black iron oxide, yellow iron oxide, propylene glycol, indigocarmin (E132) and titanium dioxide (E171).
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 (se pkt.
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 (see section 4.5).
300 mg (6 brevea)
300 mg (6 sachetsa)
Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
The expiry date refers to the last day of that month.
Samtidig administration af REYATAZ/ritonavir og stavudin forventes ikke at påvirke stavudineksponeringen signifikant.
The co-administration of REYATAZ/ritonavir with stavudine is not expected to significantly alter the exposure of stavudine.
Samtidig administration af voriconazol og REYATAZ med ritonavir frarådes medmindre det vurderes, at fordel/risikoforholdet for patienten berettiger brug af voriconazol (se pkt.
Co-administration of voriconazole and REYATAZ with ritonavir is not recommended unless an assessment of the benefit/risk to the patient justifies the use of voriconazole (see section 4.4).
Ydre æske: REYATAZ 200 mg
INFORMATION IN BRAILLE Outer carton: REYATAZ 200 mg
Koncentrationerne af elbasvir steg betydeligt ved samtidig administration med atazanavir/ritonavir.
Elbasvir concentrations were increased when co-administered with atazanavir/ritonavir.
Samtidig administration af REYATAZ og elbasvir/grazoprevir er kontraindiceret på grund af en forventet stigning i plasmakoncentrationer af grazoprevir og en associeret potentiel stigning i risiko for ALAT-stigning (se pkt.
Co-administration of REYATAZ and elbasvir/grazoprevir is contraindicated because of a significant increase in grazoprevir plasma concentrations and an associated potential increase in the risk of ALT elevations (see section 4.3).
For behandlingserfarne pædiatriske patienter var middel-baseline-CD4-celletal
For treatmentexperienced paediatric patients, the mean baseline CD4 cell count was 522 cells/mm
overfølsomhed (allergisk reaktion) usædvanlig træthed eller svaghed vægttab, vægtøgning, manglende appetit, øget appetit depression, angst, søvnforstyrrelser desorientering, hukommelsestab, svimmelhed, søvnighed, abnorme drømme besvimelse, højt blodtryk vejrtrækningsbesvær betændelse i bugspytkirtlen, irritation af slimhinden i mavesækken, sår i munden og forkølelsessår, smagsforstyrrelse, luft i maven, tør mund, udspilet mave angioødem (voldsom hævelse af hud og andre steder, som oftest læber og øjne) hårtab, kløe svind af muskelmasse, ledsmerter, muskelsmerter nyresten, nyrebetændelse (interstitiel nefritis), blod i urinen (hæmaturi), for meget protein i urinen, hyppig vandladning brystforstørrelse hos mænd brystsmerter, utilpashed, feber søvnløshed
asthenia (unusual tiredness or weakness) weight decreased, weight gain, anorexia (loss of appetite), appetite increased depression, anxiety, sleep disorder disorientation, amnesia (loss of memory), dizziness, somnolence (sleepiness), abnormal dream syncope (fainting), hypertension (high blood pressure) dyspnoea (shortness of breath) pancreatitis (inflammation of the pancreas), gastritis (inflammation of the stomach), stomatitis aphthous (mouth ulcers and cold sores), dysgeusia (impairment of the sense of taste), flatulence (wind), dry mouth, abdominal distension angioedema (severe swelling of the skin and other tissues most often the lips or the eyes) alopecia (unusual hair loss or thinning), pruritus (itching) muscle atrophy (muscle shrinkage), arthralgia (joint pain), myalgia (aching muscles) interstitial nephritis (kidney inflammation), haematuria (blood in the urine), proteinuria (excess protein in the urine), pollakiuria (increased frequency of urination) gynaecomastia (breast enlargement in men) chest pain, malaise (generally feeling unwell), fever insomnia (difficulty sleeping)
REYATAZ sammen med ritonavir er derfor kontraindiceret med lægemidler, der er substrater af CYP3A4 og har et snævert terapeutisk indeks: quetiapin, lurasidon, alfuzosin, astemizol, terfenadin, cisaprid, pimozid, quinidin, bepridil, triazolam, oralt administreret midazolam og sekalealkaloider, især ergotamin og dihydroergotamin (se pkt.
Therefore, REYATAZ with ritonavir is contraindicated with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index: quetiapine, lurasidone, alfuzosin, astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, triazolam, orally administered midazolam, and ergot alkaloids, particularly ergotamine and dihydroergotamine (see section 4.3).
Ritonavir 100 mg 1 gang dagligt (atazanavir 300 mg 1 gang dagligt)
Ritonavir 100 mg once daily (atazanavir 300 mg once daily)
Ketoconazol 200 mg 1 gang dagligt (atazanavir 400 mg 1 gang dagligt)
ANTIFUNGALS Ketoconazole 200 mg once daily (atazanavir 400 mg once daily)
Atazanavir AUC ↓61% (↓65% ↓55%) Atazanavir Cmax ↓66% (↓62% ↓49%) Atazanavir Cmin ↓65% (↓71% ↓59%)
Atazanavir (am): 2 hr after omeprazole Atazanavir AUC ↓61% (↓65% ↓55%) Atazanavir Cmax ↓66% (↓62% ↓49%) Atazanavir Cmin ↓65% (↓71% ↓59%)
Glecaprevir 300 mg / pibrentasvir 120 mg 1 gang dagligt (atazanavir 300 mg / ritonavir 100 mg 1 gang dagligt*)
Glecaprevir 300 mg / pibrentasvir 120 mg once daily (atazanavir 300 mg / ritonavir 100 mg once daily*)
Samtidig administration af REYATAZ og protonpumpehæmmere frarådes (se pkt.
Co-administration of REYATAZ with proton pump inhibitors is not recommended (see section 4.5).
Samtidig administration af efavirenz og REYATAZ frarådes (se pkt.
Co-administration of efavirenz and REYATAZ is not recommended (see section 4.4)
Serumkoncentrationen af verapamil kan øges af REYATAZ/ritonavir pga. CYP3A4-hæmning.
Serum concentrations of verapamil may be increased by REYATAZ/ritonavir due to CYP3A4 inhibition.
Dog anbefales REYATAZ ikke til patienter i hæmodialysebehandling (se pkt.
However, REYATAZ is not recommended in patients undergoing haemodialysis (see sections 4.2 and 5.2).
hiv-RNA <50 kopier/ml, % a Alle patienter hiv-RNA <400 kopier/ml, % a Alle patienter
HIV RNA <400 copies/ml, % a All patients
Samtidig administration af kombination af rifampicin og REYATAZ er kontraindiceret (se pkt.
The combination of rifampicin and REYATAZ is contraindicated (see section 4.3).
Hvert brev på 1,5 g oralt pulver indeholder 50 mg atazanavir (som sulfat).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet of 1.5 g oral powder contains 50 mg of atazanavir (as sulphate).
REYATAZ indeholder:
What REYATAZ contains
Atazanavir AUC ↓30% (↓43% ↓14%) * Atazanavir Cmax ↓31% (↓42% ↓17%) * Atazanavir Cmin ↓31% (↓46% ↓12%) *
Atazanavir (am): 1 hr after omeprazole Atazanavir AUC ↓30% (↓43% ↓14%) * Atazanavir Cmax ↓31% (↓42% ↓17%) * Atazanavir Cmin ↓31% (↓46% ↓12%) *
Ydre æske: REYATAZ 150 mg
INFORMATION IN BRAILLE Outer carton: REYATAZ 150 mg
200 mg (4 brevea)
200 mg (4 sachetsa)
REYATAZ 50 mg oralt pulver
NAME OF THE MEDICINAL PRODUCT REYATAZ 50 mg oral powder
For de behandlingserfarne pædiatriske patienter var middel-baseline-CD4-celletal 522 celler/mm3 (interval 100-1.157 celler/ mm3), og middel-baseline-plasma-hiv-1-RNA var 4,09 log10 kopier/ml (interval 3,28-5,00 log10 kopier/ml).
For treatment experienced paediatric patients, the mean baseline CD4 cell count was 522 cells/mm3 (range: 100 to 1157 cells/ mm3) and mean baseline plasma HIV-1 RNA was 4.09 log10 copies/ml (range: 3.28 to 5.00 log10 copies/ml).
Dosisjustering er ikke nødvendig ved samtidig administration af methadon og REYATAZ.
No dosage adjustment is necessary if methadone is coadministered with REYATAZ.
REATAZ er kontraindiceret hos patienter med svær leverinsufficiens (se pkt.
REYATAZ is contraindicated in patients with severe hepatic insufficiency (see sections 4.2, 4.4 and 5.2).
80 mgb mindst 35
80 mg b at least 35
Didanosin (enterokapsler) 400 mg enkeltdosis (atazanavir 300 mg 1 gang dagligt med ritonavir 100 mg 1 gang dagligt)
Didanosine (enteric coated capsules) 400 mg single dose (atazanavir 300 mg once daily with ritonavir 100 mg once daily)
Samtidig administration af stavudin og REYATAZ forventes ikke at påvirke stavudineksponeringen signifikant.
The co-administration of stavudine with REYATAZ is not expected to significantly alter the exposure of stavudine.
Hæld brevenes indhold i en lille beholder.
Fill a small container with the sachets' content.
angioødema, urticaria, alopeci, pruritus sjælden: Stevens-Johnsons syndroma,b, vesikulobulløst udslæt, eksem, vasodilatation
rare: Stevens-Johnson syndromea,b, vesiculobullous rash, eczema, vasodilatation
CD4 Middelændring fra baseline, celler/mm3
CD4 Mean Change from Baseline, cells/mm by Baseline Characteristic
Samtidig administration af REYATAZ og indinavir frarådes (se pkt.
Co-administration of REYATAZ and indinavir is not recommended (see section 4.4).