natgillin/translations-raw huggingface dataset:
Samtidigt administrerede
30 Co-administered medicinal
33 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.
4. 4 og 4. 8).
34 high drug exposures, jaundice due to indirect (unconjugated) hyperbilirubinaemia (without associated liver function test changes) or PR interval prolongations may be observed (see sections 4.4 and 4.8).
CD4- tal
36 CD4 count
Andelen af patienter med HIV RNA < 400 kopier/ ml (< 50 kopier/ ml) for REYATAZ + ritonavir var 43% (32%) og 46% (35%) for lopinavir + ritonavir.
37 lopinavir + ritonavir were 46% (35%).
Efter en enkelt dosis på 400 mg 14C- atazanavir, blev henholdsvis 79% og 13% af den totale radioaktivitet genfundet i fæces og urin.
38 Elimination: following a single 400-mg dose of 14C-atazanavir, 79% and 13% of the total radioactivity was recovered in the faeces and urine, respectively.
40 Den klonede, humane kardielle kaliumkanal, hERG, blev hæmmet med 15% i in vitro- undersøgelser ved en koncentration (30 μM) af atazanavir svarende til 30 gange den frie lægemiddelkoncentration ved Cmax hos mennesker.
During in vitro studies, cloned human cardiac potassium channel (hERG), was inhibited by 15% at a concentration (30 μ M) of atazanavir corresponding to 30-fold the free drug concentration at Cmax in humans.
41 Hvid trykfarve indeholdende:
White ink containing:
42 Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Hver kapsel indeholder 200 mg atazanavir (som sulfat).
Each capsule contains 200 mg of atazanavir (as sulphate)
109, 57 mg lactose per kapsel.
109.57 mg of lactose per capsule.
Matblå kapsler påtrykt ” BMS 200 mg ” på den ene halvdel og ” 3631 ” på den anden halvdel med hvidt blæk.
Hard capsule Opaque blue capsule printed with white ink, with "BMS 200 mg" on one half and with "3631" on the other half.
Til oral anvendelse.
42 Method of administration: for oral administration.
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.
43 There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthroses, in type A and B haemophiliac patients treated with protease inhibitors.
45 fortsattes behandlingen med proteasehæmmere, eller behandlingen blev genoptaget hvis afbrudt.
In more than half of the reported cases, treatment with protease inhibitors was continued or reintroduced if treatment had been discontinued.
Relevante eksempler er cytomegalovirus retinitis, generaliserede og/ eller fokale mycobakterielle infektioner og pneumocystis carinii pneumoni.
44 Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterial infections, and Pneumocystis carinii pneumonia.
Andre interaktioner Interaktioner mellem atazanavir/ ritonavir og proteasehæmmere, andre antiretrovirale midler end proteasehæmmere og andre ikke- antiretrovirale lægemidler angives i tabellerne neden for (stigninger er angivet med “ ↑ ”, fald med “ ↓ ”, ingen ændring med “ ↔ ”, to gange dagligt som “ BID ” og én gang dagligt som “ QD ”).
45 Other interactions Interactions between atazanavir/ ritonavir and protease inhibitors, antiretroviral agents other than protease inhibitors, and other non-antiretroviral medicinal products are listed in the tables below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, twice daily as “ BID” and once daily as “ QD”).
47 Det er vigtigt at nævne, at mange undersøgelser er udført med ikke- boosted atazanavir, hvilket ikke er det godkendte atazanavir- regime.
Of importance, many studies were conducted with unboosted atazanavir, which is not the approved regimen of atazanavir.
Samtidigt administrerede
47 Co-administered medicinal
50 Samtidigt administrerede
48 Co-administered medicinal
52
St.
Samtidigt administrerede
50 Co-administered medicinal
54 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.
4. 4 og 4. 8).
54 high drug exposures, jaundice due to indirect (unconjugated) hyperbilirubinaemia (without associated liver function test changes) or PR interval prolongations may be observed (see sections 4.4 and 4.8).
58 Tabel 2:
Table 2:
CD4- tal
56 CD4 count
Andelen af patienter med HIV RNA < 400 kopier/ ml (< 50 kopier/ ml) for REYATAZ + ritonavir var 43% (32%) og 46% (35%) for lopinavir + ritonavir.
57 lopinavir + ritonavir were 46% (35%).
Efter en enkelt dosis på 400 mg 14C- atazanavir, blev henholdsvis 79% og 13% af den totale radioaktivitet genfundet i fæces og urin.
58 Elimination: following a single 400-mg dose of 14C-atazanavir, 79% and 13% of the total radioactivity was recovered in the faeces and urine, respectively.
61 Den klonede, humane kardielle kaliumkanal, hERG, blev hæmmet med 15% i in vitro- undersøgelser ved en koncentration (30 μM) af atazanavir svarende til 30 gange den frie lægemiddelkoncentration ved Cmax hos mennesker.
During in vitro studies, cloned human cardiac potassium channel (hERG), was inhibited by 15% at a concentration (30 μ M) of atazanavir corresponding to 30-fold the free drug concentration at Cmax in humans.
Hvid trykfarve indeholdende:
White ink containing:
Shellac Titaniumdioxid( E171) Ammoniumhydroxid Propylenglycol
Shellac Titanium dioxide (E171) Ammonium hydroxide Propylene glycol Simethicone
Hver karton indeholder 60 x 1 kapsel; 10 blisterkort med 6 x 1 kapsel hver i alu/ alu- perforeret enkelt- dosis- blisterpakning
60 Each carton contains 60 x 1 capsules; 10 blister cards of 6 x 1 capsules each in Alu/ Alu perforated unit dose blisters.
63 1.
61 1.
Hver kapsel indeholder 300 mg atazanavir (som sulfat).
Each capsule contains 300 mg of atazanavir (as sulphate)
164, 36 mg lactose per kapsel.
164.36 mg of lactose per capsule.
Matrøde og blå kapsler påtrykt ” BMS 300 mg ” på den ene halvdel og ” 3622 ” på den anden halvdel med hvidt blæk.
Hard capsule Opaque red and blue capsule printed with white ink, with "BMS 300 mg" on one half and with "3622" on the other half.
Til oral anvendelse.
62 Method of administration: for oral administration.
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.
63 There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthroses, in type A and B haemophiliac patients treated with protease inhibitors.
65 fortsattes behandlingen med proteasehæmmere, eller behandlingen blev genoptaget hvis afbrudt.
In more than half of the reported cases, treatment with protease inhibitors was continued or reintroduced if treatment had been discontinued.
Relevante eksempler er cytomegalovirus retinitis, generaliserede og/ eller fokale mycobakterielle infektioner og pneumocystis carinii pneumoni.
64 Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterial infections, and Pneumocystis carinii pneumonia.
Andre interaktioner Interaktioner mellem atazanavir/ ritonavir og proteasehæmmere, andre antiretrovirale midler end proteasehæmmere og andre ikke- antiretrovirale lægemidler angives i tabellerne neden for (stigninger er angivet med “ ↑ ”, fald med “ ↓ ”, ingen ændring med “ ↔ ”, to gange dagligt som “ BID ” og én gang dagligt som “ QD ”).
65 Other interactions Interactions between atazanavir/ ritonavir and protease inhibitors, antiretroviral agents other than protease inhibitors, and other non-antiretroviral medicinal products are listed in the tables below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, twice daily as “ BID” and once daily as “ QD”).
67 Det er vigtigt at nævne, at mange undersøgelser er udført med ikke- boosted atazanavir, hvilket ikke er det godkendte atazanavir- regime.
Of importance, many studies were conducted with unboosted atazanavir, which is not the approved regimen of atazanavir.
Samtidigt administrerede
67 Co-administered medicinal
70 Samtidigt administrerede
68 Co-administered medicinal
72
St.
Samtidigt administrerede
70 Co-administered medicinal
73
71
74 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.
4. 4 og 4. 8).
74 high drug exposures, jaundice due to indirect (unconjugated) hyperbilirubinaemia (without associated liver function test changes) or PR interval prolongations may be observed (see sections 4.4 and 4.8).
78 Tabel 2:
Table 2:
78 (n=58) 76 (n=45)
76 CD4 count
Andelen af patienter med HIV RNA < 400 kopier/ ml (< 50 kopier/ ml) for REYATAZ + ritonavir var 43% (32%) og 46% (35%) for lopinavir + ritonavir.
77 lopinavir + ritonavir were 46% (35%).
Efter en enkelt dosis på 400 mg 14C- atazanavir, blev henholdsvis 79% og 13% af den totale radioaktivitet genfundet i fæces og urin.
78 Elimination: following a single 400-mg dose of 14C-atazanavir, 79% and 13% of the total radioactivity was recovered in the faeces and urine, respectively.
81 Den klonede, humane kardielle kaliumkanal, hERG, blev hæmmet med 15% i in vitro- undersøgelser ved en koncentration (30 μM) af atazanavir svarende til 30 gange den frie lægemiddelkoncentration ved Cmax hos mennesker.
During in vitro studies, cloned human cardiac potassium channel (hERG), was inhibited by 15% at a concentration (30 μ M) of atazanavir corresponding to 30-fold the free drug concentration at Cmax in humans.
Gelatine Rød jernoxid Sort jernoxid Gul jernoxid Indigocarmin (E132) Titaniumdioxid (E171)
Gelatine Red iron oxide Black iron oxide Yellow iron oxide Indigocarmin (E132) Titanium dioxide (E171)
82 Titaniumdioxid( E171) Ammoniumhydroxid Propylenglycol Simeticon
Shellac Titanium dioxide (E171) Ammonium hydroxide Propylene glycol Simethicone
6. 5 Emballagetype og pakningsstørrelser
80 6.5 Nature and contents of container
Hver æske indeholder en HDPE- beholder (high density polyethylen) eller tre HDPE (high- density polyethylene) beholdere med børnesikret polypropylenlåg.
Each carton contains one high-density polyethylene (HDPE) bottle or three high-density polyethylene (HDPE) bottles closed with child-resistant polypropylene closure.
Hver karton indeholder 30 x 1 kapsel; 5 blisterkort med 6 x 1 kapsel hver i alu/ alu- perforeret enkelt- dosis- blisterpakning
Each carton contains 30 x 1 capsules; 5 blister cards of 6 x 1 capsules each in Alu/ Alu perforated unit dose blisters.
83 Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
84 1.
81 1.
REYATAZ 50 mg/ 1, 5 g oralt pulver
REYATAZ 50 mg/ 1.5 g oral powder
Én måleske med 1, 5 g oralt pulver indeholder 50 mg atazanavir (som atazanavirsulfat).
One measuring spoon of 1.5 g oral powder contains 50 mg atazanavir (as sulphate).
150 mg aspartam og 1. 218, 15 mg saccharose per måleske med 1, 5 g oralt pulver.
150 mg of aspartame and 1,218.15 mg of sucrose per measuring spoon of 1.5 g oral powder
Gråhvidt til svagt gult pulver.
Off-white to pale yellow powder.
REYATAZ fås som oralt pulver til patienter, der ikke er i stand til at synke kapsler.
REYATAZ oral powder is available for patients who are unable to swallow capsules.
Anbefalet dosis af oralt pulver er 300 mg (6 strøgne måleskeer) én gang dagligt sammen med 100 mg ritonavir én gang dagligt og sammen med et måltid.
The recommended dose of oral powder is 300 mg (6 level measuring spoons) once daily taken with ritonavir 100 mg once daily and with food.
Én måleske med 1, 5 g oralt pulver indeholder 50 mg atazanavir.
One measuring spoon of 1.5 g of oral powder contains 50 mg atazanavir.
REYATAZ med ritonavir er ikke undersøgt hos patienter med leverinsufficiens.
REYATAZ with ritonavir has not been studied in patients with hepatic impairment.
REYATAZ med ritonavir bør anvendes med forsigtighed til patienter med let nedsat leverfunktion.
REYATAZ with ritonavir should be used with caution in patients with mild
4. 3, 4. 4 og 5. 2).
REYATAZ should not be used in patients with moderate to severe hepatic impairment (see sections 4.3, 4.4 and 5.2).
85 Oralt pulver bør tages sammen med et måltid.
The oral powder should be taken with food.
Den ordinerende læge bør tilråde patienten at dosere en skefuld løst pulver med top fra glasset ved brug af den medfølgende måleske.
The prescriber should advise the patient to scoop an overfilled spoon of loose powder from the bottle using the measuring spoon provided.
Patienten skal derefter forsigtigt afmåle pulveret i skeen ved at skrabe det overskydende pulver tilbage i glasset ved at skrabe med den flade side af en kniv eller en spatel.
The patient should then gently level the powder in the spoon by scraping the extra powder back into the bottle using a flat edge of a knife or spatula.
Patienter skal tilrådes ikke at sammenryste pulveret i skeen eller forsøge at afmåle pulveret ved at ryste eller banke på skeen.
Patients should be advised not to pack the powder into the spoon or to attempt to level the powder by shaking or tapping the spoon.
Oralt pulver kan blandes med vand, mælk, æblejuice eller yoghurt.
The oral powder may be mixed with water, milk, applesauce or yoghurt.
Når oralt pulver er opblandet, bør det indtages inden for 6 timer.
Once the oral powder is mixed with these, it should be used within 6 hours.
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
Man bør udvise særlig forsigtighed, når
83 bundle-branch block), REYATAZ should be used with caution and only if the benefits exceed the risk (see section 5.1).
En arsagssammenhæng er antydet, selvom virkningsmekanismen ikke er klarlagt.
A causal relationship has been suggested, although the mechanism of action has not been elucidated.
Diabetikere REYATAZ oralt pulver indeholder 7, 3 g sukrose per 300 mg daglig dosis.
Diabetics REYATAZ oral powder contains 7.3 g sucrose per 300 mg daily dose.
Der bør tages højde for dette hos patienter med diabetes mellitus.
This should be taken into account in patients with diabetes mellitus.
Patienter med sjældne arvelige problemer med fruktoseintoleranzs, glukose- galaktosemalabsorption eller sucrase- isomaltaseinsufficiens bør ikke tage denne medicin.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
De langsigtede konsekvenser ved disse hændelser er for øjeblikket ukendte.
The long-term consequences of these reactions are currently unknown.
Indinavir er ligeledes forbundet med indirekte (ukonjugeret) hyperbilirubinæmi relateret til hæmning af UGT.
84 Indinavir is also associated with indirect (unconjugated) hyperbilirubinaemia due to inhibition of UGT.
Dosis af protonpumpehæmmere bør ikke overstige dosis svarende til omeprazol 20 mg.
Phenylketonuria
Fenylketonuri REYATAZ oralt pulver indeholder aspartam som sødemiddel.
85 REYATAZ oral powder contains aspartame as a sweetening agent.
Aspartam er en fenylalaninkilde og er derfor ikke egnet til personer med fenylketonuri.
Aspartame provides a source of phenylalanine and, therefore, may not be suitable for persons with phenylketonuria.
Ved samtidig administration af REYATAZ og ritonavir kan ritonavirs metaboliske lægemiddelinteraktionsprofil dominere, idet ritonavir er en mere potent CYP3A4- hæmmer end
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.
Andre interaktioner Interaktioner mellem atazanavir/ ritonavir og proteasehæmmere, andre antiretrovirale midler end proteasehæmmere og andre ikke- antiretrovirale lægemidler angives i tabellerne neden for (stigninger er angivet med “ ↑ ”, fald med “ ↓ ”, ingen ændring med “ ↔ ”, to gange dagligt som “ BID ” og én gang dagligt som “ QD ”).
Other interactions Interactions between atazanavir/ ritonavir and protease inhibitors, antiretroviral agents other than protease inhibitors, and other non-antiretroviral medicinal products are listed in the tables below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, twice daily as “ BID” and once daily as “ QD”).
90% konfidensintervaller (KI) angives i parentes hvis de er tilgængelige.
If available, 90% confidence intervals (CI) are shown in parentheses.
Det er vigtigt at nævne, at mange forsøg er udført med ikke- boosted atazanavir, hvilket ikke er det godkendte atazanavir- regime.
Of importance, many studies were conducted with unboosted atazanavir, which is not the approved regimen of atazanavir.
Undersøgelse udført med HIV - inficerede patienter
studies conducted in HIV- infected patients
Der er ikke set signifikant effekt på koncentrationen af lamivudin eller zidovudin.
No significant effect on lamivudine and zidovudine concentrations observed.
Didanosin (tabletter med buffer) 200 mg/ stavudin 40 mg, begge som enkeltdoser (atazanavir 400 mg som enkeltdosis)
products (dose in mg)
↓0, 13 ↓0, 11 ↓0, 16 atazanavir, (0, 08; 0, 21) (0, 06; 0, 18) (0, 10; 0, 27) samtidig administration med ddI+d4T 89 (fastende)
(90% CI) (90% CI) (90% CI)
Samtidig administration af
co-administration
Samtidigt administrerede lægemidler (dosis i mg)
Didanosine (buffered tablets) 200 mg/ stavudine 40 mg, both single dose (atazanavir 400 mg
Vurderet AUC Cmax Cmin lægemiddel (90% KI) (90% KI) (90% KI)
Didanosine should be taken at the fasted state 2 hours after
Anbefalinger vedrørende samtidig administration
co-administration of
REYATAZ /
REYATAZ/ ritonavir
atazanavir, doseret 1 time efter ↔1, 03 ↑1, 12 ↔1, 03 ddI+d4T (0, 64; 1, 67) (0, 67; 1, 18) (0, 61; 1, 73) (fastende)
(fasted)
ritonavir og stavudin forventes ikke at påvirke optagelsen af stavudin i betydelig
with stavudine is not expected to
Atazanavir- koncentrationen faldt meget ved samtidig administration med didanosin (tabletter med buffer) og stavudin.
Atazanavir concentrations were greatly decreased when co-administered with didanosine (buffered tablets) and stavudine.
grad.
↑ 1.25
Didanosin (entero- overtrukne kapsler) 400 mg enkeltdosis (atazanavir 300 mg QD med
capsules) 400 mg single dose (atazanavir 300 mg QD with
Didanosin (med ↓0, 66 ↓0, 62 ↑1, 25 mad) (0, 59; 0, 73) (0, 52; 0, 74) (0, 92; 1, 69)
(0.92, 1.69)
Der er ikke set signifikant påvirkning af atazanavirkoncentrationen ved samtidig administration af entero- overtrukne didanosin- tabletter, men administration med mad fik didanosinkoncentrationen til at falde.
No significant effect on atazanavir concentrations was observed when administered with enteric-coated didanosine, but administration with food decreased didanosine concentrations.
Tenofovir- disoproxilfumarat
Tenofovir disoproxil fumarate
↓0, 78 * ↓0, 84 * ↓0, 77 * atazanavir
↓ 0.78 * ↓ 0.84 * ↓ 0.77 * atazanavir
Undersøgelse udført med HIV- inficerede patienter.
300 mg QD (atazanavir 300 mg QD with ritonavir 100 mg QD) studies conducted in HIV- infected patients
(0, 65; 0, 94) (0, 70; 1, 00) (0, 57- 1, 02) * I en kombineret analyse af flere kliniske forsøg, hvor atazanavir/ ritonavir 300/ 100 mg administreret samtidig med tenofovir - disoproxilfumarat 300 mg (n=39) blev sammenlignet med atazanavir/ ritonavir 300/ 100 mg (n=33).
(0.65, 0.94) (0.70, 1.00) (0.57-1.02) * In a combined analysis from several clinical studies, atazanavir/ ritonavir 300/ 100 mg co-administered with tenofovir disoproxil fumarate 300 mg (n=39) was compared to atazanavir/ ritonavir 300/ 100 mg (n=33).
Tenofovir- disoproxilfumarat
Tenofovir disoproxil fumarate 300 mg QD (atazanavir 300
Patienterne skal
tenofovir
300 mg QD (atazanavir 300 mg QD med ritonavir 100 mg
Patients should be closely monitored for
tenofovir - disoproxil -
mg QD with ritonavir 100 mg
↑1, 34
↑ 1.37 ↑ 1.34 ↑ 1.29 disoproxil
monitoreres tæt for tenofovir- relaterede
tenofovir-associated
(1, 21; 1, 36)
(1.30, 1.45) (1.20, 1.51) (1.21, 1.36) fumarate
Forsøg
nevirapine with REYATAZ/ ritonavir is
udført med HIV- inficerede
conducted in HIV infected
patienter Antibiotika
patients Antibiotics
ritonavir frarådes (se pkt.
section 4.4)
4. 4)
87
↑1, 94 ↑1, 50 ↑2, 60 clarithromycin
clarithromycin
(1, 75; 2, 16) (1, 32; 1, 71) (2, 35; 2, 88) 14- OH ↓0, 30 ↓0, 28 ↓0, 38
(2.35, 2.88)
clarithromycin (0, 26; 0, 34) (0, 24; 0, 33) (0, 34; 0, 42)
clarithromycin
derfor udvises forsigtighed hvis
therefore, caution
↑1, 28 ↔1, 06 ↑1, 91 atazanavir (1, 16; 1, 43) (0, 93; 1, 20) (1, 66; 2, 21)
(0.26, 0.34)
REYATAZ / ritonavir administreres
(0.24, 0.33)
Dosisreduktion i clarithromycin kan medføre subterapeutiske
(0.34, 0.42)
samtidig med
should be exercised if
90
atazanavir
Samtidigt administrerede
↑ 1.28
Vurderet AUC Cmax Cmin
↔ 1.06
Anbefalinger
↑ 1.91
lægemidler (dosis i mg)
REYATAZ/ ritonavir is co-administered with
lægemiddel
(1.16, 1.43)
(90% KI) (90% KI) (90% KI)
(0.93, 1.20)
vedrørende samtidig administration
(1.66, 2.21)
koncentrationer af 14- OH clarithromycin.
A dose reduction of clarithromycin may result in subtherapeutic concentrations of 14-OH clarithromycin.
clarithromycin.
clarithromycin.
forsigtighed ved samtidig administration med
High doses of ketoconazole and
På baggrund af data fra andre boostede PI' er og ketoconazol, hvor ketoconazol- AUC stiger x 3, forventes REYATAZ/ ritonavir at øge ketoconazol - og itraconazolkoncentrationer.
Based on data obtained with other boosted PIs and ketoconazole, where ketoconazole AUC showed a 3-fold increase, REYATAZ/ ritonavir is expected to increase ketoconazole or itraconazole concentrations.
Høje doser ketoconazol og itraconazol (> 200 mg/ dag) frarådes.
itraconazole (> 200 mg/ day) are not recommended.
Samtidig administration af REYATAZ/ ritonavir og voriconazol er ikke undersøgt.
Co-administration of REYATAZ/ ritonavir and voriconazole has not been studied.
Samtidig administration af voriconazol og
Co-administration of voriconazole and REYATAZ/ ritonavir is
Der er ved forsøg på at kompensere for den nedsatte optagelse ved at øge dosis af REYATAZ, eller andre proteasehaemmere med ritonavir, set høj frekvens af leverreaktioner
During attempts to overcome the decreased exposure by increasing the dose of REYATAZ or other protease inhibitors with ritonavir, a high frequency of liver reactions was seen.
↓ 0, 82 ↓0, 86 ↓0, 72
atazanavir ↓ 0.82 ↓ 0.86 ↓ 0.72
(0, 64; 0, 81)
88
91 Samtidigt administrerede
Co-administered medicinal
Protonpumpehæmmere
(atazanavir 300 mg QD with