FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: Absorpcija: pri bolnikih, okuženih z virusom HIV (n=33, kombinirane študije), je bila pri ponavljajočih se odmerkih zdravila REYATAZ v odmerku 300 mg enkrat na dan z ritonavirjem v odmerku 100 mg enkrat na dan skupaj s hrano geometrijska srednja vrednost Cmax (KV%) atazanavirja 4.466 (42%) ng/ml.
English: For children who cannot eat solid food or drink from a cup, REYATAZ oral powder must be mixed with infant formula and should be given using an oral syringe.
Slovenian: Otrokom, ki ne morejo uživati goste hrane ali piti iz kozarca, je treba zdravilo REYATAZ peroralni prašek zmešati z začetno formulo za dojenčke in dati s pomočjo brizge za peroralno dajanje.
English: 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.
Slovenian: c Glavne substitucije zaviralcev proteaz L24I, D30N, V32I, L33F, M46IL, I47AV, G48V, I50LV, F53LY, I54ALMSTV, L76V, V82AFLST, I84V, N88DS, L90M; redkejše substitucije zaviralcev proteaz: L10CFIRV, V11I, E35G, K43T, Q58E, A71ILTV, G73ACST, T74P, N83D, L89V.
English: MARKETING AUTHORISATION NUMBER(S) Bottle pack
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z
English: If you accidentally take more REYATAZ capsules than your doctor recommended, contact your HIV doctor at once or contact the nearest hospital for advice.
Slovenian: Če ste po nesreči vzeli prevelik odmerek zdravila REYATAZ, se takoj posvetujte z zdravnikom ali poiščite pomoč v najbližji bolnišnici.
English: 80 mgc at least 15 to less than 35
Slovenian: 80 mgc najmanj 15 do manj kot 35
English: Nevirapine AUC ↑26% (↑17% ↑36%) Nevirapine Cmax ↑21% (↑11% ↑32%) Nevirapine Cmin ↑35% (↑25% ↑47%)
Slovenian: Nevirapin AUC ↑26% (↑17% ↑36%) Nevirapin Cmax ↑21% (↑11% ↑32%) Nevirapin Cmin ↑35% (↑25% ↑47%)
English: The dose and the number of REYATAZ oral powder sachets needed is determined based on weight (see section 4.2.
Slovenian: Navodila za uporabo: Odmerek in število potrebnih vrečic zdravila REYATAZ peroralni prašek se določi na osnovi telesne mase (glejte poglavje 4.2).
English: OUTER CARTON TEXT (BOTTLE AND BLISTER PRESENTATIONS) AND BOTTLE LABEL TEXT
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI BESEDILO NA ŠKATLI (PAKIRANJI PLASTENKA IN PRETISNI OMOT) IN NALEPKI ZA PLASTENKO
English: CORTICOSTEROIDS Fluticasone propionate intranasal 50 µg 4 times daily for 7 days (ritonavir 100 mg capsules twice daily)
Slovenian: KORTIKOSTEROIDI Flutikazonpropionat za intranazalno uporabo 50 µg 4-krat na dan, 7 dni (ritonavir 100 mg kapsule dvakrat na dan)
English: It is not known whether REYATAZ with ritonavir administered to the mother during pregnancy will exacerbate physiological hyperbilirubinaemia and lead to kernicterus in neonates and infants.
Slovenian: Ni znano, ali lahko zdravilo REYATAZ z ritonavirjem, če ga jemljejo nosečnice, poslabša fiziološko hiperbilirubinemijo in pri novorojenčkih in dojenčkih povzroči kernikterus.
English: REYATAZ is also available as an oral powder for use in children at least 3 months old and weighing at least 5 kg.
Slovenian: Zdravilo REYATAZ je na voljo tudi v obliki peroralnega praška za uporabo pri otrocih, starih najmanj 3 mesece in s telesno maso najmanj 5 kg.
English: Co-administration of REYATAZ with voxilaprevircontaining products is expected to increase the concentration of voxilaprevir.
Slovenian: Pri sočasni uporabi zdravila REYATAZ in zdravil, ki vsebujejo voksilaprevir, je pričakovati povečanje koncentracij voksilaprevirja.
English: Larger volumes or quantities of liquid infant formula, beverage or food may be used.
Slovenian: Uporabite lahko večje volumne ali količine začetne tekoče formule za dojenčke, napitka ali hrane.
English: There were fewer treatment discontinuations in the unboosted REYATAZ group (1 vs. 4 subjects in the REYATAZ + ritonavir group).
Slovenian: Zdravljenje je bilo manjkrat prekinjeno v skupini z zdravilom REYATAZ brez okrepitve (1 bolnik v primerjavi s 4 bolniki v skupini z zdravilom REYATAZ + ritonavir).
English: HIV RNA <400 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
Slovenian: HIV RNA <400 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
English: 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).
Slovenian: Okvara jeter: Atazanavir se primarno presnavlja v jetrih in pri bolnikih z okvaro jeter so opažali zvišanje njegove koncentracije v plazmi (glejte poglavji 4.2 in 4.3).
English: Interactions with other medicinal products The combination of REYATAZ with atorvastatin is not recommended (see section 4.5).
Slovenian: Medsebojno delovanje z drugimi zdravili Zdravila REYATAZ ni priporočljivo uporabljati v kombinaciji z atorvastatinom (glejte poglavje 4.5).
English: Assessment of the pharmacokinetics, safety, tolerability, and virologic response of REYATAZ oral powder was based on data from two open-label, multicenter clinical trials.
Slovenian: Preskušanja, izvedena z zdravilom REYATAZ v obliki peroralnega praška pri pediatrični populaciji Ocena farmakokinetike, varnosti, prenašanja in virusnega odziva na zdravljenje z zdravilom REYATAZ v obliki peroralnega praška temelji na podatkih iz dveh odprtih, multicentričnih kliničnih preskušanj.
English: The M184I/V substitution emerged in 5/26 REYATAZ/ritonavir and 7/26 lopinavir/ritonavir virologic failure patients, respectively.
Slovenian: Substitucija M184I/V se je pri zdravljenju z zdravilom REYATAZ/ritonavirjem pojavila pri 5/26 bolnikov z virusnim neodzivom, pri zdravljenju z lopinavirjem/ritonavirjem pa pri 7/26 bolnikov z virusnim neodzivom.
English: What REYATAZ looks like and contents of the pack
Slovenian: Izgled zdravila REYATAZ in vsebina pakiranja
English: Excipient with known effect: 82.18 mg of lactose per capsule.
Slovenian: Pomožna snov z znanim učinkom: 82,18 mg laktoze na kapsulo.
English: Both asymptomatic first-degree (23%) and second-degree (1%) atrioventricular block were reported in paediatric patients.
Slovenian: Pri pediatričnih bolnikih so poročali o asimptomatskem atrioventrikularnem bloku prve (23%) in druge (1%) stopnje.
English: Co-administration with REYATAZ with ritonavir warrants clinical monitoring for sedation and cognitive effects.
Slovenian: Pri sočasni uporabi zdravila REYATAZ z ritonavirjem je potreben klinični nadzor sedacije in učinkov na kognitivno funkcijo.
English: Sildenafil, tadalafil, vardenafil Sildenafil, tadalafil and vardenafil are metabolised by CYP3A4.
Slovenian: Sildenafil, tadalafil in vardenafil se presnavljajo s CYP3A4.
English: Co-administration of a single 300 mg dose of REYATAZ and 100 mg dose of ritonavir with a light meal resulted in a 33% increase in the AUC and a 40% increase in both the Cmax and the 24 hour concentration of atazanavir relative to the fasting state.
Slovenian: V primerjavi z uporabo na tešče so se pri uporabi enkratnega 300 mg odmerka zdravila REYATAZ in 100 mg odmerka ritonavirja skupaj z lahkim obrokom vrednosti AUC, Cmax in 24-urne koncentracije atazanavirja povečale, in sicer AUC za 33%, Cmax in 24-urna koncentracija pa za 40%.
English: The geometric mean (CV%) for atazanavir Cmin and AUC were 120 (109) ng/ml and 14874 (91) ng•h/ml, respectively.
Slovenian: Geometrijska srednja vrednost Cmin (KV%) atazanavirja je znašala 120 (109) ng/ml, geometrijska srednja vrednost AUC (KV%) atazanavirja pa 14.874 (91) ng•h/ml.
English: * When compared to atazanavir 300 mg once daily with ritonavir 100 mg once daily.
Slovenian: * Pri primerjavi z atazanavirjem 300 mg enkrat na dan z ritonavirjem 100 mg enkrat na dan.
English: When given with REYATAZ, the recommended dose of rifabutin is 150 mg 3 times per week on set days (for example Monday-Wednesday-Friday).
Slovenian: Pri sočasni uporabi v kombinaciji z zdravilom REYATAZ je priporočeni odmerek rifabutina 150 mg 3-krat na teden na določene dneve (na primer ponedeljek-sreda-petek).
English: When co-administered with tenofovir disoproxil fumarate, it is recommended that REYATAZ 300 mg be given with ritonavir 100 mg and tenofovir disoproxil fumarate 300 mg (all as a single dose with food).
Slovenian: Pri sočasni uporabi dizoproksiltenofovirijevega fumarata je priporočljivo zdravilo REYATAZ v odmerku 300 mg uporabljati skupaj z ritonavirjem v odmerku 100 mg in dizoproksiltenofovirijevim fumaratom v odmerku 300 mg (vse v obliki enkratnega odmerka skupaj s hrano).
English: ERECTILE DYSFUNCTION PDE5 Inhibitors
Slovenian: ZDRAVILA ZA ZDRAVLJENJE EREKTILNE DISFUNKCIJE Zaviralci PDE5
English: Co-administration of simvastatin or lovastatin with REYATAZ is contraindicated due to an increased risk of myopathy including rhabdomyolysis (see section 4.3).
Slovenian: Sočasna uporaba simvastatina ali lovastatina z zdravilom REYATAZ je kontraindicirana zaradi večjega tveganja za pojav miopatije, vključno z rabdomiolizo (glejte poglavje 4.3).
English: Methadone, stable maintenance dose (atazanavir 400 mg once daily)
Slovenian: Metadon, stabilni vzdrževalni odmerek (atazanavir 400 mg enkrat na dan)
English: Patients should be warned about these possible side effects when using PDE5 inhibitors for erectile dysfunction with REYATAZ/ritonavir (see section 4.4).
Slovenian: Bolnike je treba opozoriti na te možne neželene učinke pri uporabi zaviralcev PDE5 za zdravljenje erektilne disfunkcije, če se jih uporablja skupaj z zdravilom REYATAZ/ ritonavirjem (glejte poglavje 4.4).
English: There are other medicines that may not mix with REYATAZ.
Slovenian: So tudi druga zdravila, ki jih ne smete jemati v kombinaciji z zdravilom REYATAZ.
English: Didanosine should be taken at the fasted state 2 hours after REYATAZ taken with food.
Slovenian: Didanozin mora bolnik jemati na prazen želodec 2 uri po zdravilu REYATAZ, ki ga vzame skupaj s hrano.
English: Co-administration with REYATAZ/ritonavir has the potential to produce a decrease or, less often, an increase in INR (International Normalised Ratio).
Slovenian: Pri sočasni uporabi zdravila REYATAZ/ritonavirja se lahko vrednost INR (internacionalno normalizirano razmerje) zmanjša, v redkejših primerih pa tudi poveča.
English: If you accidentally take or give more REYATAZ oral powder than your doctor recommended, contact your HIV doctor at once or contact the nearest hospital for advice.
Slovenian: Če ste po nesreči vzeli ali dali prevelik odmerek zdravila REYATAZ, se takoj posvetujte z zdravnikom ali poiščite pomoč v najbližji bolnišnici.
English: Excipient with known effect: 164.36 mg of lactose per capsule.
Slovenian: Pomožna snov z znanim učinkom: 164,36 mg laktoze na kapsulo.
English: It is not known whether REYATAZ administered to the mother during pregnancy will exacerbate physiological hyperbilirubinaemia and lead to kernicterus in neonates and infants.
Slovenian: Ni znano, ali lahko zdravilo REYATAZ, če ga jemljejo nosečnice, poslabša fiziološko hiperbilirubinemijo in pri novorojenčkih in dojenčkih povzroči kernikterus.
English: Patients should be warned about these possible side effects when using PDE5 inhibitors for erectile dysfunction with REYATAZ (see section 4.4).
Slovenian: Bolnike je treba opozoriti na te možne neželene učinke pri uporabi zaviralcev PDE5 za zdravljenje erektilne disfunkcije, če se jih uporablja skupaj z zdravilom REYATAZ (glejte poglavje 4.4).
English: If an oral contraceptive is administered with REYATAZ/ritonavir, it is recommended that the oral contraceptive contain at least 30 μg of ethinyloestradiol and that the patient be reminded of strict compliance with this contraceptive dosing regimen.
Slovenian: Če se peroralni kontraceptiv uporablja skupaj z zdravilom REYATAZ/ritonavirjem je priporočljivo, da peroralni kontraceptiv vsebuje vsaj 30 μg etinilestradiola.
English: NAME OF THE MEDICINAL PRODUCT REYATAZ 50 mg oral powder
Slovenian: IME ZDRAVILA REYATAZ 50 mg peroralni prašek
English: A dose reduction of buprenorphine may be considered.
Slovenian: Odmerek buprenorfina bo morda treba zmanjšati.
English: The full amount of the mixture is drawn up into an oral syringe and administered into either right or left inner cheek of the infant.
Slovenian: Celotno količino mešanice izvlecite v brizgo za peroralno dajanje in jo iztisnite otroku v usta v smeri proti desnemu ali levemu licu.
English: Concentrations of atazanavir were not significantly affected.
Slovenian: Koncentracije atazanavirja se niso pomembneje spremenile.
English: 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.
Slovenian: V klinični študiji AI424-020 je zdravljenje pediatričnih bolnikov, starih od 3 mesecev do manj kot 18 let, z zdravilom REYATAZ v obliki peroralnega praška ali kapsul v povprečju trajalo 115 tednov.
English: Put another 10 ml of prepared infant formula in the cup or container and rinse the remaining oral powder from the cup or container.
Slovenian: V merico ali vsebnik dajte še dodatnih 10 ml pripravljene začetne formule za dojenčke in izplaknite preostali peroralni prašek v merici ali posodici.
English: common: headache; uncommon: peripheral neuropathy, syncope, amnesia, dizziness, somnolence, dysgeusia
Slovenian: pogosti: glavobol; občasni: periferna nevropatija, sinkopa, amnezija, omotica, somnolenca, paragevzija
English: The Summary of Product Characteristics for ritonavir must be consulted before initiation of therapy with REYATAZ and ritonavir.
Slovenian: Pred začetkom zdravljenja z zdravilom REYATAZ in ritonavirjem je treba prebrati povzetek glavnih značilnosti ritonavirja.
English: Co-administration of voriconazole and REYATAZ with ritonavir is not recommended, unless an assessment of the benefit/risk justifies the use of voriconazole.
Slovenian: Sočasna uporaba vorikonazola in zdravila REYATAZ z ritonavirjem ni priporočljiva, razen če ocena koristi/tveganj opraviči uporabo vorikonazola.
English: Ensure that all the infant formula, beverage or food that contains the medicine is taken.
Slovenian: Poskrbite, da bo otrok zaužil celotno količino začetne tekoče formule za dojenčke, napitka ali hrane, ki vsebuje zdravilo.
English: LIPID LOWERING AGENTS HMG-CoA reductase inhibitors Simvastatin
Slovenian: ZDRAVILA ZA ZMANJŠANJE RAVNI LIPIDOV Zaviralci reduktaze HMG-CoA Simvastatin Lovastatin
English: Hepatic transaminase elevations that occur with elevated bilirubin in patients receiving REYATAZ should be evaluated for alternative aetiologies.
Slovenian: Če se pri bolniku, ki se zdravi z zdravilom REYATAZ, pojavi zvišanje vrednosti jetrnih transaminaz, ki jih spremlja zvišanje vrednosti bilirubina, je treba ugotoviti morebiten alternativni vzrok.
English: It is important that you take REYATAZ with food (a meal or a substantial snack) as this helps the body absorb the medicine.
Slovenian: Zdravilo REYATAZ skupaj s hrano in pijačo Pomembno je, da zdravilo REYATAZ jemljete skupaj s hrano (med kosilom ali z obilnejšim obrokom) in tako telesu olajšate absorpcijo zdravila.
English: Reversible elevations in indirect (unconjugated) bilirubin related to inhibition of UDP-glucuronosyl transferase (UGT) have occurred in patients receiving REYATAZ (see section 4.8).
Slovenian: Pri bolnikih, ki so se zdravili z zdravilom REYATAZ, se je pojavilo reverzibilno zvišanje indirektnega (nekonjugiranega) bilirubina, kar je povezano z zaviranjem UDP-glukuroniltransferaze (UGT) (glejte poglavje 4.8).
English: Paediatric patients (at least 3 months of age and weighing at least 5 kg) The doses of atazanavir oral powder and ritonavir for paediatric patients are based on body weight as shown in Table 1.
Slovenian: Pediatrični bolniki (stari najmanj 3 mesece in s telesno maso najmanj 5 kg) Odmerek atazanavirja v obliki peroralnega praška pri pediatričnih bolnikih temelji na njihovi telesni masi, kot prikazuje preglednica 1.
English: There was less hyperbilirubinaemia and jaundice in the unboosted REYATAZ group compared with the REYATAZ + ritonavir group (18 and 28 subjects, respectively).
Slovenian: V skupini z zdravilom REYATAZ brez okrepitve so poročali o manj primerih hiperbilirubinemije in zlatenice kot v skupini z zdravilom REYATAZ + ritonavir (18 bolnikov v primerjavi z 28 bolniki).
English: 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.
Slovenian: Sočasne uporabe zdravila REYATAZ/ritonavirja z drugimi hormonskimi kontraceptivi ali peroralnimi kontraceptivi, ki vsebujejo drug gestagen in ne norgestimat, niso raziskovali.
English: The REYATAZ/ritonavir arm has similar (non-inferior) antiviral efficacy compared to the lopinavir/ritonavir arm, as assessed by the proportion of patients with HIV RNA < 50 copies/ml at week 48: 78% of patients on REYATAZ/ritonavir compared to 76% on lopinavir/ritonavir (difference estimate of ATV/RTV-LPV/RTV: 1.7% [95% CI, -3.8%, 7.1%] according to the Confirmed Virologic Response (CVR) Non-Completer = Failure (NC = F) definition of response.
Slovenian: V skupini, ki je prejemala zdravilo 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: 78% bolnikov v skupini, ki je prejemala zdravilo REYATAZ/ritonavir v primerjavi s 76% bolnikov v skupini, ki je prejemala lopinavir/ritonavir (ocenjena razlika ATV/RTV-LPV/RTV: 1,7% [95% interval zaupanja,3,8%; 7,1%].
English: Each carton contains one high-density polyethylene (HDPE) bottle or three high-density polyethylene (HDPE) bottles closed with child-resistant polypropylene closure.
Slovenian: Ena škatla vsebuje eno plastenko iz polietilena visoke gostote ali tri plastenke iz polietilena visoke gostote.
English: 14-OH clarithromycin 14-OH clarithromycin AUC ↓70% 14-OH clarithromycin Cmax ↓72% 14-OH clarithromycin Cmin ↓62%
Slovenian: 14-OH klaritromicin 14-OH klaritromicin AUC ↓70% (↓74%
English: Co-administration of REYATAZ with these medicinal products is expected to substantially increase their concentrations and may result in PDE5-associated adverse reactions such as hypotension, visual changes and priapism (see section 4.5).
Slovenian: Pri sočasni uporabi zdravila REYATAZ in teh zdravil pričakujemo znaten porast njihovih koncentracij, kar posledično lahko privede do pojava neželenih učinkov zaviralcev PDE5, kot so hipotenzija, spremembe vida in priapizem (glejte poglavje 4.5).
English: Treatment-Experienced REYATAZ Powder/ritonavir n=82
Slovenian: Predhodno že zdravljeni bolniki REYATAZ prašek/ritonavir n=82
English: Table 1: Dose of REYATAZ oral powder with ritonavir for paediatric patientsa (at least 3 months of age and weighing at least 5 kg)
Slovenian: Preglednica 1: Odmerek zdravila REYATAZ v obliki peroralnega praška skupaj z ritonavirjem pri pediatričnih bolnikiha (starih najmanj 3 mesece in s telesno maso najmanj 5 kg)
English: 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).
Slovenian: Pri predhodno še nezdravljenih bolnikih, ki so zdravilo REYATAZ v odmerku 300 mg enkrat na dan skupaj z ritonavirjem v odmerku 100 mg enkrat na dan prejemali v povprečju 96 tednov, se je zvišanje vrednosti bilirubina 3. in 4. stopnje pojavilo pri 48% bolnikov (glejte poglavje 4.4).
English: Since atazanavir is extensively metabolised by the liver and is highly protein bound, dialysis is unlikely to be beneficial in significant removal of this medicinal product.
Slovenian: Specifičnega antidota za preveliko odmerjanje zdravila REYATAZ ni. Atazanavir se izdatno presnavlja v jetrih in se v veliki meri veže na beljakovine v plazmi, zato ni verjetno, da bi dializa kaj dosti koristila pri njegovi odstranitvi.
English: * When compared to REYATAZ 300 mg and ritonavir 100 mg without nevirapine.
Slovenian: * Pri primerjavi zdravila REYATAZ v odmerku 300 mg in ritonavirja v odmerku 100 mg brez nevirapina.
English: * When compared to atazanavir 300 mg once daily with ritonavir 100 mg once daily and tenofovir disoproxil fumarate 300 mg all as a single dose with food.
Slovenian: * V primerjavi z uporabo atazanavirja v odmerku 300 mg enkrat na dan, ritonavirja v odmerku 100 mg enkrat na dan in dizoproksiltenofovirijevega fumarata v odmerku 300 mg, vse v obliki enkratnega odmerka skupaj s hrano.
English: If REYATAZ is co-administered with irinotecan, patients should be closely monitored for adverse events related to irinotecan.
Slovenian: Če se zdravilo REYATAZ uporablja skupaj z irinotekanom, je bolnika treba skrbno nadzirati glede pojava neželenih učinkov irinotekana.
English: NAME OF THE MARKETING AUTHORISATION HOLDER BRISTOL-MYERS SQUIBB PHARMA EEIG
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM BRISTOL-MYERS SQUIBB PHARMA EEIG
English: Patients should be closely monitored for tenofovir disoproxil-associated adverse reactions, including renal disorders.
Slovenian: Bolnike je treba skrbno nadzirati glede pojava neželenih učinkov dizoproksiltenofovirata, vključno z motnjami delovanja ledvic.
English: When given with REYATAZ/ritonavir, the recommended dose of rifabutin is 150 mg 3 times per week on set days (for example MondayWednesday-Friday).
Slovenian: Pri sočasni uporabi v kombinaciji z zdravilom REYATAZ/ritonavirjem je priporočeni odmerek rifabutina 150 mg 3-krat na teden na določene dneve (na primer ponedeljek-sredapetek).
English: Ketoconazole and itraconazole should be used cautiously with REYATAZ/ritonavir.
Slovenian: Ketokonazol in itrakonazol je treba uporabljati previdno skupaj z zdravilom REYATAZ/ritonavirjem.
English: Each bottle contains 60 hard capsules.
Slovenian: Ena plastenka vsebuje 60 trdih kapsul.
English: The most frequently reported laboratory abnormalities in paediatric patients receiving REYATAZ was elevation of total bilirubin (≥ 2.6 times ULN, Grade 3-4) which occurred in 45% of patients.
Slovenian: Pri laboratorijskih meritvah so pri pediatričnih bolnikih, ki so prejemali zdravilo REYATAZ, najpogosteje poročali o povečani koncentraciji celokupnega bilirubina (≥ 2,6-krat nad zgornjo mejo referenčnih vrednosti, stopnja 3-4), in sicer pri 45% bolnikov.
English: - in patients without a functional CYP2C19 allele, close clinical and laboratory monitoring of voriconazole-associated adverse events is recommended.
Slovenian: - pri bolnikih brez funkcionalnega alela CYP2C19 se priporoča skrben nadzor kliničnih in laboratorijskih parametrov glede neželenih učinkov vorikonazola.
English: No dosage adjustments are needed for REYATAZ/ritonavir and fluconazole.
Slovenian: Odmerkov zdravila REYATAZ/ritonavirja ali flukonazola ni treba prilagajati.
English: 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.
Slovenian: Pri predhodno že zdravljenih bolnikih, ki so zdravilo REYATAZ v odmerku 300 mg enkrat na dan skupaj z ritonavirjem v odmerku 100 mg enkrat na dan prejemali v povprečju 95 tednov, se je zvišanje vrednosti bilirubina 3. in 4. stopnje pojavilo pri 53% bolnikov.
English: ATV/RTVb (300 mg/ 100 mg once daily) n=120
Slovenian: ATV/RTVb (300 mg/ 100 mg enkrat na dan) n=120
English: uncommon: weight decreased, weight gain, anorexia, appetite increased
Slovenian: Presnovne in prehranske motnje: občasni: zmanjšanje telesne mase, povečanje telesne mase, anoreksija, povečan apetit
English: 80 mg b at least 35
Slovenian: 80 mg b najmanj 35