natgillin/translations-raw huggingface dataset:
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%).
Z analizo "kot so bili zdravljeni" in ob izključitvi manjkajočih vrednosti, je bil delež bolnikov s HIV RNA < 400 kopij/ml (< 50 kopij/ml) za REYATAZ + ritonavir 84% (72%) in za lopinavir + ritonavir 82% (72%).
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.
Pri laboratorijskih meritvah so pri pediatričnih bolnikih, ki so prejemali zdravilo REYATAZ v obliki peroralnega praška, najpogosteje poročali o povečani koncentraciji celokupnega bilirubina (≥ 2,6-krat nad zgornjo mejo referenčnih vrednosti, stopnja 3-4; 16%) in zvišanju vrednosti amilaze (stopnja 3-4; 33%), ki je običajno bilo nepankreasnega porekla.
Each carton contains 30 sachets.
Ena škatla vsebuje 30 vrečic.
REYATAZ capsules must be taken with ritonavir and have to be taken with food.
Kapsule REYATAZ je treba jemati skupaj z ritonavirjem in skupaj s hrano.
50 to <100 cells/mm3
50 do <100 celic/mm3
100 to <200 cells/mm3
100 do <200 celic/mm3
REYATAZ oral powder should be taken/given with food (e.g. applesauce or yogurt) or drinks (e.g. milk, infant formula or water) for infants who can drink from a cup.
Dojenčkom, ki lahko pijejo iz kozarca, je treba zdravilo REYATAZ peroralni prašek dajati skupaj s hrano (npr. jabolčna čežana ali jogurt) ali napitkom (npr. mleko, začetna formula za dojenčke ali voda).
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.
C: Priprava mešanice priporočenega števila vrečic zdravila REYATAZ peroralni prašek s hrano, kot je jabolčna čežana ali jogurt, v manjši posodici: Vsebino vrečic primešajte eni jedilni žlici hrane.
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.
Pri bolnikih, okuženih z virusom HIV (n=13), je pri ponavljajočih se odmerkih zdravila REYATAZ v odmerku 400 mg (brez ritonavirja) enkrat na dan skupaj s hrano geometrijska srednja vrednost Cmax (KV%) atazanavirja znašala 2.298 (71) ng/ml, vrednost Cmax pa je bila dosežena približno po 2,0 urah.
f Intent-to-treat analysis, with missing values considered as failures.
f Analiza vključenih bolnikov (“Intent-to-treat analysis”), manjkajoče vrednosti obravnavane kot neuspeh.
Concomitant use of REYATAZ/ritonavir and fluticasone or other glucocorticoids that are metabolised by CYP3A4 is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression (see section 4.5).
Sočasne uporabe zdravila REYATAZ/ritonavirja in flutikazona ali drugih glukokortikoidov, ki se presnavljajo s CYP3A4, ne priporočamo, razen v primerih, ko možne koristi zdravljenja prevladajo nad tveganjem za pojav sistemskih kortikosteroidnih učinkov, vključno s Cushingovim sindromom in z zaviralnim vplivom na nadledvično žlezo (glejte poglavje 4.5).
At least 5 to less than 15
najmanj 5 do manj kot 15
Switching from REYATAZ oral powder to REYATAZ capsules is encouraged as soon as patients are able to consistently swallow capsules.
Prehod z zdravljenja z zdravilom REYATAZ v obliki peroralnega praška na zdravljenje z zdravilom REYATAZ v obliki kapsul je priporočljiv takoj, ko lahko bolniki kapsule zanesljivo pogoltnejo.
When compared to atazanavir 300 mg with ritonavir 100 mg without tenofovir, atazanavir concentrations are expected to be additionally decreased by about 20%.
Pri uporabi atazanavirja v odmerku 300 mg in ritonavirja v odmerku 100 mg brez tenofovirja, pa pričakujemo, da se bodo koncentracije atazanavirja še dodatno zmanjšale za približno 20%.
For inclusion in both trials, treatment-naive patients had to have genotypic sensitivity to REYATAZ and two NRTIs, and treatment-experienced patients had to have documented genotypic and phenotypic sensitivity at screening to REYATAZ and at least 2 NRTIs.
Za vključitev v obe preskušanji so predhodno nezdravljeni bolniki morali imeti genotipsko senzitivnost na zdravilo REYATAZ in dva NRTI-ja, predhodno že zdravljeni bolniki pa dokumentirano genotipsko in fenotipsko senzitivnost pri presejanju na zdravilo REYATAZ in vsaj 2 NRTI-ja. Bolniki, ki so bilo protiretrovirusnim zdravilom izpostavljeni le in utero ali med porodom, so bili obravnavani kot predhodno nezdravljeni.
250 mg (5 sachets a)
250 mg (5 vrečic a)
Quinidine has a narrow therapeutic window and is contraindicated due to potential inhibition of CYP3A by REYATAZ.
Kinidin ima ozko terapevtsko okno, njegova uporaba pa je kontraindicirana zaradi možne inhibicije CYP3A z zdravilom REYATAZ.
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.
Pri sočasni uporabi zdravila REYATAZ in ritonavirja lahko prevladajo presnovne interakcijske značilnosti ritonavirja, saj je ritonavir močnejši zaviralec CYP3A4 kot atazanavir.
REYATAZ is also available in capsules for use in adults and children at least 6 years of age who weigh at least 15 kg and who are able to swallow the capsules.
Zdravilo REYATAZ je na voljo tudi v obliki kapsul za uporabo pri otrocih, starih najmanj 6 let in s telesno maso najmanj 15 kg, ki lahko pogoltnejo kapsule.
The most frequently reported laboratory abnormality in patients receiving regimens containing REYATAZ and one or more NRTIs was elevated total bilirubin reported predominantly as elevated indirect [unconjugated] bilirubin (87% Grade 1, 2, 3, or 4).
Najpogostejša patološka laboratorijska vrednost pri bolnikih, zdravljenih s shemami, ki so vključevale zdravilo REYATAZ in enega ali več zaviralcev nukleozidne/nukleotidne reverzne transkriptaze, je bilo zvišanje vrednosti celotnega bilirubina, predvsem indirektnega [nekonjugiranega] bilirubina (87% 1., 2., 3. ali 4. stopnje).
Co-administration with grazoprevir-containing products, including elbasvir/grazoprevir fixed dose combination (see section 4.5).
Sočasna uporaba z zdravili, ki vsebujejo grazoprevir, vključno s fiksno kombinacijo elbasvir/grazoprevir (glejte poglavje 4.5).
If it is almost time for your or your child's next dose, do not take or give the missed dose.
Če je že skoraj čas za naslednji odmerek, ne vzemite ali dajte pozabljenega odmerka.
*Ritonavir capsules, tablets or oral solution may be used.
*Uporablja se lahko ritonavir v obliki kapsul, tablet ali peroralne raztopine.
The dose of REYATAZ capsules for children is calculated by body weight and is taken once daily with food and 100 mg ritonavir as shown below:
Odmerek kapsul REYATAZ za otroke se izračuna na osnovi telesne mase in se ga jemlje enkrat na dan skupaj s hrano in 100 mg ritonavirja, kot je prikazano v spodnji preglednici:
Your child's doctor will decide the right dose based on your child's age and weight.
Ustrezen odmerek zdravila bo določil otrokov zdravnik na osnovi starosti in telesne mase otroka.
If REYATAZ/ritonavir is coadministered with irinotecan, patients should be closely monitored for adverse events related to irinotecan.
Če se zdravilo REYATAZ/ritonavir uporablja skupaj z irinotekanom, je bolnika treba skrbno nadzirati glede pojava neželenih učinkov irinotekana.
Based on these data and because ritonavir is not expected to have a significant impact on the pharmacokinetics of NRTIs, the co-administration of these medicinal products and REYATAZ is not expected to significantly alter the exposure of the co-administered medicinal products.
Na osnovi teh podatkov in ker pomembnejšega vpliva ritonavirja na farmakokinetiko NRTI-jev ne pričakujemo, pri sočasni uporabi teh zdravil in zdravila REYATAZ ne pričakujemo, da bi se izpostavljenost sočasno uporabljenim zdravilom pomembneje spremenila.
The REYATAZ/ritonavir arm showed 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 (Table 5).
REYATAZ/ritonavir, je bila protivirusna učinkovitost podobna (ni bila manjša) kot v skupini, ki je prejemala lopinavir/ritonavir, kar je bilo ovrednoteno z deležem bolnikov z vrednostjo HIV RNA < 50 kopij/ml v 48. tednu (preglednica 5).
QT prolongation: Dose related asymptomatic prolongations in PR interval with REYATAZ have been observed in clinical studies.
Podaljšanje intervala QT: Pri zdravljenju z zdravilom REYATAZ so v kliničnih študijah opazili od odmerka odvisno asimptomatsko podaljšanje intervala PR.
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)
Preglednica 1: Odmerek za pediatrične bolnike (stare od 6 do manj kot 18 let in s telesno maso najmanj 15 kg) za kapsule REYATAZ skupaj z ritonavirjem
There are no pharmacokinetic data available for REYATAZ with ritonavir in patients with renal insufficiency.
Farmakokinetičnih podatkov o sočasni uporabi zdravila REYATAZ z ritonavirjem pri bolnikih z ledvično insuficienco ni.
Do not take or give a double dose to make up for a forgotten dose.
Ne vzemite ali dajte dvojnega odmerka, če ste pozabili vzeti ali dati prejšnji odmerek.
Quinidine has a narrow therapeutic window and is contraindicated due to potential inhibition of CYP3A by REYATAZ/ritonavir.
Kinidin ima ozko terapevtsko okno, njegova uporaba pa je kontraindicirana zaradi možne inhibicije CYP3A z zdravilom REYATAZ/ ritonavirjem.
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.
V odprti, randomizirani primerjalni študiji je po 26- do 30-tedenskem indukcijskem obdobju zdravljenja z zdravilom REYATAZ 300 mg + ritonavir 100 mg enkrat na dan in dvema NRTI-jema protivirusna učinkovitost med 48-tedenskim vzdrževalnim obdobjem zdravljenja pri z virusom HIV okuženih bolnikih s popolno supresijo replikacije virusa HIV pri zdravljenju z zdravilom REYATAZ 400 mg enkrat na dan brez okrepitve in dvema NRTI-jema (n=87) bila enaka kot pri zdravljenju z zdravilom REYATAZ + ritonavir in dvema NRTI-jema (n=85), kar so ovrednotili z deležem bolnikov z vrednostjo HIV RNA < 50 kopij/ml: 78% bolnikov pri zdravljenju z zdravilom REYATAZ brez okrepitve in dvema NRTI-jema v primerjavi s 75% bolnikov pri zdravljenju z zdravilom REYATAZ + ritonavirjem in dvema NRTI-jema.
Do not take sildenafil with REYATAZ when sildenafil is used for the treatment of pulmonary arterial hypertension.
Med zdravljenjem z zdravilom REYATAZ ne smete uporabljati sildenafila za zdravljenje pljučne arterijske hipertenzije.
When compared to atazanavir 300 mg with ritonavir 100 mg without tenofovir disoproxil fumarate, atazanavir concentrations are expected to be additionally decreased by about 20%.
Pri uporabi atazanavirja v odmerku 300 mg in ritonavirja v odmerku 100 mg brez dizoproksiltenofovirijevega fumarata pa pričakujemo, da se bodo koncentracije atazanavirja še dodatno zmanjšale za približno 20%.
15 to less than 35 at least 35
15 do manj kot 35 najmanj 35
PHARMACEUTICAL FORM AND CONTENTS Carton and label bottle pack (1 bottle): 60 hard capsules Blister pack: 60 hard capsules
FARMACEVTSKA OBLIKA IN VSEBINA Škatla in nalepka, pakiranje v plastenki (1 plastenka): 60 trdih kapsul Pakiranje v pretisnem omotu: 60 trdih kapsul
C-atazanavir, 79% and 13% of the total radioactivity was recovered in the faeces and urine, respectively.
C-označenega atazanavirja se je 79% radioaktivnosti pojavilo v blatu in 13% v urinu.
CD4 Mean Change from Baseline, cells/mm3 All patients
Srednja sprememba števila celic CD4 od izhodišča, celice/mm3 Vsi bolniki
Studies conducted in HIVinfected patients.
Študije, izvedene pri bolnikih, okuženih z virusom HIV.
Consult the dosing table for the specific formulation (see Summary of Product Characteristics for REYATAZ oral powder).
Glejte tabelo za odmerjanje posamezne farmacevtske oblike (glejte povzetek glavnih značilnosti zdravila REYATAZ peroralni prašek).
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).
Zdravilo REYATAZ v obliki peroralnega praška je ob sočasni uporabi majhnih odmerkov ritonavirja in v kombinaciji z drugimi protiretrovirusnimi zdravili indicirano za zdravljenje s HIV-1 okuženih pediatričnih bolnikov, starih najmanj 3 mesece in s telesno maso najmanj 5 kg (glejte poglavje 4.2).
Due to CYP3A4 inhibition by REYATAZ, concentrations of quetiapine are expected to increase.
Ker zdravilo REYATAZ zavira CYP3A4, pričakujemo povečanje koncentracij kvetiapina.
Integrase Inhibitors Raltegravir 400 mg twice daily (atazanavir/ritonavir)
Zaviralci integraze Raltegravir 400 mg dvakrat na dan (atazanavir/ritonavir)
Yellowing of your skin or the white part of your eyes caused by high levels of bilirubin in your blood has been commonly reported.
Pogosto so poročali o rumenem obarvanju kože ali očesnih beločnic, ki je posledica visokih vrednosti bilirubina v krvi.
Protease inhibitors: The co-administration of REYATAZ/ritonavir and other protease inhibitors has not been studied but would be expected to increase exposure to other protease inhibitors.
Zaviralci proteaz: Sočasne uporabe zdravila REYATAZ/ritonavirja in drugih zaviralcev proteaz niso raziskovali.
An additional 15 ml of beverage is added to the drinking cup for thorough rinsing of the cup and contents are mixed.
V kozarec nalijte še dodatnih 15 ml napitka, kozarec temeljito izplaknite in vsebino premešajte.
REYATAZ oral powder must be taken with ritonavir and has to be taken with food.
Zdravilo REYATAZ peroralni prašek je treba jemati skupaj z ritonavirjem in skupaj s hrano.
REYATAZ should be administered 2 hours before or 1 hour after antacids or buffered medicinal products.
Zdravilo REYATAZ je treba uporabljati 2 uri pred ali 1 uro po uporabi antacida ali zdravila, ki vsebuje pufer.
* 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).
* Kombinirana analiza več kliničnih študij, v katerih so uporabo atazanavirja/ritonavirja 300/100 mg skupaj z dizoproksiltenofovirijevim fumaratom v odmerku 300 mg (n=39) primerjali z uporabo atazanavirja/ritonavirja 300/100 mg (n=33).
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).
Zdravilo REYATAZ peroralni prašek se lahko uporablja pri otrocih, starih najmanj 3 mesece in s telesno maso najmanj 5 kg (glejte poglavje 3 Kako jemati zdravilo REYATAZ).
uncommon: torsades de pointesa rare: QTc prolongationa, oedema, palpitation
občasni: torsade de pointesa; redki: podaljšanje intervala QTca, edem, palpitacije
HIV RNA <50 copies/ml, %a at least 5 to < 10 kg (REYATAZ 150 and 200 mg) at least 10 to < 15 kg at least 15 to < 25 kg at least 25 to < 35 kg
HIV RNA <50 kopij/ml, %a najmanj 5 do < 10 kg (REYATAZ 150 in 200 mg) najmanj 10 do < 15 kg najmanj 15 do < 25 kg najmanj 25 do < 35 kg
100 mgd a The same recommendations regarding the timing and maximum doses of concomitant proton pump inhibitors and H2receptor antagonists in adults also apply to paediatric patients (see section 4.5).
100 mgd a Pri pediatričnih bolnikih je treba upoštevati ista priporočila za sočasno uporabo zaviralcev protonske črpalke in antagonistov receptorjev H2 (čas uporabe in največji odmerek) kot pri odraslih (glejte poglavje 4.5).
In clinical trial AI424-182 REYATAZ/ritonavir (300/100 mg or 400/100 mg) in combination with zidovudine/lamivudine was administered to 41 pregnant women during the second or third trimester.
V kliničnem preskušanju AI424-182 je 41 nosečnic med drugim in tretjim trimesečjem nosečnosti prejemalo zdravilo REYATAZ/ritonavir (300/100 mg ali 400/100 mg) v kombinaciji z zidovudinom/lamivudinom.
Given that low dose ritonavir (100 mg twice daily) has been shown to have no significant effect on methadone concentrations, no interaction is expected if methadone is coadministered with REYATAZ and ritonavir, based on these data.
Glede na to, da je bilo dokazano, da nizki odmerek ritonavirja (100 mg dvakrat na dan) nima pomembnega vpliva na koncentracije metadona, na osnovi teh podatkov pri sočasni uporabi metadona, zdravila REYATAZ in ritonavirja interakcij ne pričakujemo.
Renal impairment: No dosage adjustment is needed in patients with renal impairment.
Okvara ledvic: Pri bolnikih z okvaro ledvic odmerka ni treba prilagajati.
The geometric mean (CV%) for atazanavir Cmin and AUC was 654 (76%) ng/ml and 44185 (51%) ng•h/ml, respectively.
Geometrijska srednja vrednost Cmin (KV%) atazanavirja je bila 654 (76%) ng/ml, geometrijska srednja vrednost AUC (KV%) atazanavirja pa 44.185 (51%) ng•h/ml.
a Intent-to-treat analysis, with missing values considered as failures.
a Analiza vključenih bolnikov (“Intent-to-treat analysis”), z manjkajočimi vrednostmi, ki so obravnavane kot neuspeh.
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%,
Pri analizi po protokolu, ki je izključila bolnike, ki niso dokončali študije (to je bolnike, ki so bili iz študije izključeni pred vrednotenjem vrednosti HIV RNA v 48. tednu) in bolnike z bistvenimi odstopanji od protokola, je v 48. tednu vrednost HIV RNA < 50 kopij/ml imelo 86 % bolnikov (338/392) v skupini, ki je prejemala zdravilo REYATAZ/ritonavir, in 89% bolnikov (332/372) v skupini, ki je prejemala lopinavir/ritonavir (ocenjena razlika ATV/RTV-LPV/RTV: -3% [95% interval zaupanja, -7,6%; 1,5%].
b Each sachet contains 50 mg of atazanavir.
b Ena vrečica vsebuje 50 mg atazanavirja.
How to store REYATAZ 6.
Shranjevanje zdravila REYATAZ 6.
Rare (may affect up to 1 in 1,000 people): gait disturbance (abnormal manner of walking) oedema (swelling) hepatosplenomegaly (enlargement of the liver and spleen) myopathy (aching muscles, muscle tenderness of weakness, not caused by exercise) kidney pain
Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): motnje hoje (nenormalen način hoje); edem (oteklina); hepatosplenomegalija (povečanje jeter in vranice); miopatija (bolečina, občutljivost ali slabost mišic, ki ni posledica telesnega napora); bolečine v ledvicah.
The proportion of patients with HIV RNA < 400 copies/ml were 53% and 43% for ATV/RTV and 54% and 46% for LPV/RTV at weeks 48 and 96 respectively.
Delež bolnikov s HIV RNA < 400 kopij/ml je bil v 48. tednu pri kombinaciji ATV/RTV 53%, pri kombinaciji LPV/RTV pa 54%.
Didanosine (with food) Didanosine AUC ↓34% (↓41% ↓27%) Didanosine Cmax ↓38% (↓48% ↓26%) Didanosine Cmin ↑25% (↓8% ↑69%)
Didanozin (skupaj s hrano) Didanozin AUC ↓34% (↓41% ↓27%) Didanozin Cmax ↓38% (↓48% ↓26%) Didanozin Cmin ↑25% (↓8% ↑69%)
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).
Če je potrebna uporaba dizoproksiltenofovirata ali antagonista receptorjev H2, je treba razmisliti o povečanju odmerka zdravila REYATAZ na 400 mg z ritonavirjem 100 mg ob sočasnem spremljanju koncentracij zdravila (glejte poglavji 4.6 in 5.2).
REYATAZ oral powder should be given within 60 minutes of mixing.
Zdravilo REYATAZ peroralni prašek morate otroku dati v 60 minutah po pripravi mešanice.
Polyester film/Aluminum/Polyethylene sealant film sachet.
Vrečica iz poliesterske folije/aluminija/polietilenske tesnilne folije.
Unboosted REYATAZ must not be used in patients with severe hepatic impairment.
Zdravila REYATAZ brez okrepitve farmakokinetike se ne sme uporabljati pri bolnikih s hudo okvaro jeter.
Add 10 ml of prepared liquid infant formula and mix using a spoon.
Dodajte 10 ml pripravljene začetne tekoče formule za dojenčke in zmešajte z žlico.
For further details on the preparation and administration of the REYATAZ oral powder, see the Patient Information Leaflet, Instructions for Use section
Za nadaljnje podrobnosti glede priprave in dajanja zdravila REYATAZ peroralni prašek glejte poglavje Navodila za uporabo v navodilu za uporabo.
At baseline, 34% of patients were receiving a PI and 60% were receiving an NNRTI.
Izhodiščno je 34% bolnikov dobivalo zaviralce proteaz in 60% NNRTI-je.
propylene glycol, indigocarmin (E132) and titanium dioxide (E171).
Ovojnice kapsul: želatina, indigotin (E132) in titanov dioksid (E171).
Either one or three bottles of 60 hard capsules are provided in one carton.
V eni škatli so na voljo ena ali tri plastenke s po 60 trdimi kapsulami.
By as-treated analysis, excluding missing values, the proportions of patients with HIV RNA < 400 copies/ml (< 50 copies/ml) in the REYATAZ + ritonavir arm and the lopinavir + ritonavir arm were 55% (40%) and 56% (46%), respectively.
Po analizi "kot so bili zdravljeni" (z izključitvijo manjkajočih vrednosti) je bil delež bolnikov s HIV RNA < 400 kopij/ml (< 50 kopij/ml) v kraku z zdravilom REYATAZ + ritonavirjem 55% (40%) in v kraku z lopinavirjem + ritonavirjem 56% (46%).
CD4 count <50 cells/mm3
Število celic CD4 <50 celic/mm
Co-administration of lamotrigine and REYATAZ/ritonavir may decrease lamotrigine plasma concentrations due to UGT1A4 induction.
Pri sočasni uporabi lamotrigina in zdravila REYATAZ/ritonavirja se zaradi indukcije UGT1A4 lahko zmanjšajo koncentracije lamotrigina v plazmi.
Pregnancy and Postpartum
Nosečnost in poporodno obdobje
Didanosine should be taken at the fasted state 2 hours after REYATAZ/ritonavir taken with food.
Didanozin mora bolnik jemati na prazen želodec 2 uri po zdravilu REYATAZ/ritonavirju, ki ju vzame skupaj s hrano.
Some people will need special care before or while taking REYATAZ.
Nekateri ljudje morajo biti posebej previdni pri jemanju zdravila REYATAZ.
For children (at least 3 months of age and weighing at least 5 kg), your child's doctor will decide the right dose based on your child's weight.
Pri otrocih (starih najmanj 3 mesece in s telesno maso najmanj 5 kg) bo ustrezen odmerek določil otrokov zdravnik na osnovi telesne mase otroka.
PDE5 inhibitors used for the treatment of erectile dysfunction: particular caution should be used when prescribing PDE5-inhibitors (sildenafil, tadalafil, or vardenafil) for the treatment of erectile dysfunction in patients receiving REYATAZ.
Uporaba zaviralcev PDE5 za zdravljenje erektilne disfunkcije: pri bolnikih, ki se zdravijo z zdravilom REYATAZ, je potrebna posebna previdnost pri predpisovanju zaviralcev PDE5 (sildenafil, tadalafil ali vardenafil) za zdravljenje erektilne disfunkcije.
Sildenafil, when used for the treatment of pulmonary arterial hypertension, is contraindicated (see section 4.3).
Uporaba sildenafila za zdravljenje pljučne arterijske hipertenzije je kontraindicirana (glejte poglavje 4.3).
MARKETING AUTHORISATION NUMBER(S) EU/1/03/267/001-006; 008-011
EU/1/03/267/001-006; 008-011
Combination of rifampicin with concomitant low-dose ritonavir (see section 4.5).
Sočasna uporaba rifampicina skupaj z nizkim odmerkom ritonavirja (glejte poglavje 4.5).