FrancophonIA/ELRC3.0 huggingface dataset:
English: Rashes are usually mild-to-moderate maculopapular skin eruptions that occur within the first 3 weeks of starting therapy with REYATAZ.
Slovenian: Izpuščaji so običajno blagi do zmerni makulopapulozni izbruhi na koži, ki se lahko pojavijo v prvih 3 tednih po začetku zdravljenja z zdravilom REYATAZ.
English: REYATAZ 100 mg hard capsules REYATAZ 150 mg hard capsules REYATAZ 200 mg hard capsules REYATAZ 300 mg hard capsules
Slovenian: REYATAZ 100 mg trde kapsule REYATAZ 150 mg trde kapsule REYATAZ 200 mg trde kapsule REYATAZ 300 mg trde kapsule
English: For the recommended paediatric dosage, REYATAZ oral powder contains 3915.45 mg sucrose per 150 mg atazanavir, 5220.60 mg sucrose per 200 mg atazanavir, 6525.75 mg sucrose per 250 mg atazanavir, and 7830.90 mg sucrose per 300 mg atazanavir.
Slovenian: Pri priporočenih pediatričnih odmerkih zdravilo REYATAZ peroralni prašek tako vsebuje 3.915,45 mg saharoze na 150 mg atazanavirja, 5.220,60 mg saharoze na 200 mg atazanavirja, 6.525,75 mg saharoze na 250 mg atazanavirja in 7.830,90 mg saharoze na 300 mg atazanavirja.
English: Children receiving REYATAZ may require their heart to be monitored.
Slovenian: Pri otrocih, ki prejemajo zdravilo REYATAZ, bo morda treba spremljati delovanje srca, o čemer se bo odločil otrokov zdravnik.
English: Distribution: atazanavir was approximately 86% bound to human serum proteins over a concentration range of 100 to 10,000 ng/ml.
Slovenian: Porazdelitev: atazanavir je v koncentracijskem območju od 100 do 10.000 ng/ml približno 86% vezan na beljakovine v človeškem serumu.
English: In a multiple-dose study in HIVinfected patients dosed with 400 mg of atazanavir once daily with a light meal for 12 weeks, atazanavir was detected in the cerebrospinal fluid and semen.
Slovenian: Pri bolnikih, okuženih s HIV, ki so v študiji z večkratnim odmerjanjem 12 tednov dobivali 400 mg atazanavirja enkrat na dan z lahkim obrokom, so atazanavir našli v cerebrospinalnem likvorju in semenu.
English: The frequency of treatment emergent hepatitis or transaminase elevations in co-infected patients was comparable between REYATAZ and comparator regimens (see section 4.4).
Slovenian: Pogostnost med zdravljenjem nastalega hepatitisa ali zvišanja transaminaz pri sočasno okuženih bolnikih je bila primerljiva med zdravilom REYATAZ in primerjalnimi shemami (glejte poglavje 4.4).
English: Add a minimum of one tablespoon of food and mix.
Slovenian: Dodajte vsaj eno jedilno žlico hrane in premešajte.
English: Other marked clinical laboratory abnormalities (Grade 3 or 4) reported in ≥ 2% of patients receiving regimens containing REYATAZ and one or more NRTIs included: elevated creatine kinase (7%), elevated alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/SGPT) (5%), low neutrophils (5%), elevated aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT) (3%), and elevated lipase (3%).
Slovenian: Druge izrazite patološke laboratorijske vrednosti (3. ali 4. stopnje), opisane pri ≥ 2% bolnikih, ki so prejemali zdravilo REYATAZ in enega ali več NRTI-jev, so: zvišanje kreatin-kinaze (7%), zvišanje alanin-aminotransferaze/serumske glutamat-piruvat transaminaze (ALT/SGPT) (5%), zmanjšanje števila nevtrofilcev (5%), zvišanje aspartat-aminotransferaze/serumske glutamat-oksalacetat transaminaze (AST/SGOT) (3%) in zvišanje lipaze (3%).
English: Protease inhibitor resistance was defined as genotypic resistance to atazanavir or either component of the local NRTI backbone based on the criteria of 1) any major mutations: I50L, I84V, N88S and 2) ≥ 2 of the following minor or cross resistant mutations: M46I/L, G48V, I54L/V/M/T/A, V82A/T/FI, L90M, V32I.
Slovenian: Odpornost proti zaviralcu proteaz je bila opredeljena kot genotipska odpornost proti atazanavirju ali kateri koli sestavini lokalnega osnovnega NRTI-ja na osnovi naslednjih meril: 1) katera koli večja mutacija: I50L, I84V, N88S in 2) 2 ali več od naslednjih manjših mutacij ali mutacij navzkrižne odpornosti: M46I/L, G48V, I54L/V/M/T/A, V82A/T/FI, L90M, V32I.
English: Of importance, many studies were conducted with unboosted atazanavir, which is not the approved regimen of atazanavir.
Slovenian: Pomembno je izpostaviti, da so bile številne študije izvedene brez okrepitve farmakokinetike atazanavirja, kar pa ni odobren režim uporabe atazanavirja.
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART).
Slovenian: Čeprav je vzrokov verjetno več (vključno z uporabo kortikosteroidov, uživanjem alkohola, hudo imunosupresijo, višjim indeksom telesne mase), so o primerih osteonekroze poročali zlasti pri bolnikih z napredovalo boleznijo HIV ali dolgotrajno izpostavljenostjo kombiniranemu protiretrovirusnemu zdravljenju (CART - "combination antiretroviral therapy") ali obojim.
English: Liver problems may uncommonly happen.
Slovenian: Občasno lahko pride do težav z jetri.
English: Patients who received REYATAZ or REYATAZ/ritonavir at any time prior to study enrollment or who had a history of treatment failure on two or more protease inhibitors, protease inhibitor resistance or evidence of pre-existing cardiac abnormalities were excluded from the trials.
Slovenian: Bolniki, ki so prejemali zdravilo REYATAZ ali REYATAZ/ritonavir kadar koli pred vključitvijo v študijo, bolniki, pri katerih je bilo predhodno zdravljenje z dvema ali več zaviralci proteaz neuspešno, bolniki z odpornostjo proti zaviralcu proteaz in bolniki z znaki že prisotnih srčnih nepravilnosti, so bili izključeni iz kliničnih preskušanj.
English: The M184V substitution in reverse transcriptase, which confers resistance to lamivudine and emtricitabine, was detected in 2 subjects in the unboosted REYATAZ and 1 subject in the REYATAZ + ritonavir group.
Slovenian: Substitucijo M184V reverzne transkriptaze, ki je povezana z odpornostjo proti lamivudinu in emtricitabinu, so zasledili pri 2 bolnikih v skupini z zdravilom REYATAZ brez okrepitve in 1 bolniku v skupini z zdravilom REYATAZ + ritonavir.
English: If REYATAZ oral powder is mixed with water, food should also be taken at the same time.
Slovenian: Če se zdravilo REYATAZ peroralni prašek zmeša z vodo, mora otrok sočasno zaužiti tudi hrano.
English: Not all pack sizes may be marketed in all countries.
Slovenian: Na trgu morda ni vseh navedenih pakiranj.
English: Itraconazole, like ketoconazole, is a potent inhibitor as well as a substrate of CYP3A4.
Slovenian: Itrakonazol je podobno kot ketokonazol močan zaviralec in tudi substrat za CYP3A4.
English: - The other ingredients are crospovidone, lactose monohydrate, and magnesium stearate.
Slovenian: - Druge sestavine zdravila so krospovidon, laktoza monohidrat in magnezijev stearat.
English: Add another 15 ml of the drink, mix and have the child drink the mixture.
Slovenian: Dodajte še dodatnih 15 ml napitka in premešajte, otrok pa naj mešanico izpije.
English: LIST OF EXCIPIENTS Contains aspartame and sucrose.
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje aspartam in saharozo.
English: As a result, greater peak to trough ratios are observed; however at recommended doses, geometric mean atazanavir exposures (Cmin, Cmax and AUC) in paediatric patients are expected to be similar to those observed in adults.
Slovenian: Posledično so opažali večje razmerje med največjo in najmanjšo koncentracijo, vendar pa se pri priporočenih odmerkih pričakuje, da bo geometrična srednja izpostavljenost atazanavirju (Cmin, Cmax in AUC) pri pediatričnih bolnikih podobna kot pri odraslih.
English: In clinical studies, REYATAZ (with or without ritonavir) has been shown to induce dyslipidaemia to a lesser extent than comparators.
Slovenian: V kliničnih študijah so ugotovili, da zdravilo REYATAZ (z ritonavirjem ali brez) povzroča dislipidemijo v manjši meri kot primerjalna zdravila.
English: During this time, postpartum patients should follow the same dose recommendation as for nonpregnant patients, including those for co-administration of medicinal products known to affect atazanavir exposure (see section 4.5).
Slovenian: V tem obdobju je treba za bolnice upoštevati priporočeno odmerjanje za ne-noseče bolnice, vključno s priporočili glede sočasne uporabe zdravil, za katera je znano, da vplivajo na izpostavljenost atazanavirju (glejte poglavje 4.5).
English: REYATAZ (without ritonavir) has been studied in adult subjects with moderate-to-severe hepatic impairment (14 Child-Pugh Class B and 2 Child-Pugh Class C subjects) after a single 400 mg dose.
Slovenian: Uporabo zdravila REYATAZ (brez ritonavirja) so raziskovali pri odraslih osebah z zmerno do hudo okvaro jeter (14 oseb Child-Pugh B in 2 osebi Child-Pugh C) po enkratnem 400 mg odmerku.
English: The use of REYATAZ may be considered during pregnancy only if the potential benefit justifies the potential risk.
Slovenian: Med nosečnostjo se sme zdravilo REYATAZ uporabljati le, če možne koristi upravičujejo možna tveganja.
English: common: fatigue; uncommon: chest pain, malaise, pyrexia, asthenia; rare: gait disturbance a These adverse reactions were identified through post-marketing surveillance, however, the frequencies were estimated from a statistical calculation based on the total number of patients exposed to REYATAZ in randomised controlled and other available clinical trials (n = 2321).
Slovenian: pogosti: utrujenost; občasni: bolečina v prsnem košu, splošno slabo počutje, zvišana telesna temperatura, astenija; redki: motnje hoje a O teh neželenih učinkih so poročali med spremljanjem zdravila po pridobitvi dovoljenja za promet, pogostnosti pa so bile ocenjene s pomočjo statističnega izračuna na osnovi skupnega števila bolnikov, ki so se z zdravilom REYATAZ zdravili v randomiziranih nadzorovanih in drugih izvedenih kliničnih preskušanjih (n = 2.321).
English: Hepatic impairment: atazanavir is metabolised and eliminated primarily by the liver.
Slovenian: Okvara jeter: atazanavir se večinoma presnavlja in izloča v jetrih.
English: Withdrawal of ritonavir only under restrictive conditions The recommended standard treatment is REYATAZ boosted with ritonavir, ensuring optimal pharmacokinetic parameters and level of virologic suppression.
Slovenian: Priporočeno standardno zdravljenje z zdravilom REYATAZ, okrepljeno z ritonavirjem, zagotavlja optimalne farmakokinetične parametre in nivo virusne supresije.
English: b Number of patients evaluable.
Slovenian: b Število ovrednotenih bolnikov.
English: Week 48: -3% [-7.6%, 1.5%] Week 96: 2.2% [-2.3%, 6.7%] HIV RNA <50 copies/ml, % by Baseline Characteristicd HIV RNA <100,000 copies/ml
Slovenian: 48. teden: -3% [-7,6%; 1,5%] 96. teden: 2,2% [-2,3%; 6,7%] HIV RNA <50 kopij/ml, % glede na izhodiščne lastnosti d
English: Efficacy data observed in the 41 paediatric patients aged 6 years to less than 18 years that received REYATAZ capsules with ritonavir are presented in Table 7.
Slovenian: Podatki o učinkovitosti zdravila pri 41 pediatričnih bolnikih, starih od 6 do manj kot 18 let, ki so prejemali kapsule REYATAZ skupaj z ritonavirjem, so predstavljeni v preglednici 7.
English: Your doctor may adjust the dose of REYATAZ according to your anti-HIV therapy.
Slovenian: Zdravnik bo točno odredil vaš odmerek zdravila REYATAZ glede na druga zdravila proti HIV.
English: HERBAL PRODUCTS St. John's wort (Hypericum perforatum)
Slovenian: PRIPRAVKI RASTLINSKEGA IZVORA Šentjanževka (Hypericum perforatum)
English: [95% CI]
Slovenian: [95% interval zaupanja]
English: Add 30 ml of the drink and mix with a spoon.
Slovenian: Dodajte 30 ml napitka in zmešajte z žlico.
English: For treatment-experienced paediatric patients, the mean baseline CD4 cell count was 1441 cells/mm
Slovenian: Pri predhodno že zdravljenih pediatričnih bolnikih je srednje število celic CD4 v izhodišču znašalo 1.441 celic/mm
English: Calcium channel blockers Bepridil
Slovenian: Zaviralci kalcijevih kanalčkov Bepridil
English: Determine the dose and the number of REYATAZ oral powder sachets needed (see section 3 How to take REYATAZ).
Slovenian: Določite odmerek in število potrebnih vrečic zdravila REYATAZ peroralni prašek (glejte poglavje 3 Kako jemati zdravilo REYATAZ).
English: In case of withdrawal of ritonavir from the recommended atazanavir boosted regimen (see section 4.4) The same recommendations for drug drug interactions would apply except: that co-administration is not recommended with tenofovir, boceprevir, carbamazepine, phenytoin, phenobarbital, proton pump inhibitors, and buprenorphine.
Slovenian: V primeru odtegnitve ritonavirja iz priporočenega režima zdravljenja z okrepitvijo farmakokinetike atazanavirja (glejte poglavje 4.4) Upoštevati je treba enaka priporočila za medsebojno delovanje med zdravili, razen: sočasna uporaba ni priporočljiva s tenofovirjem, boceprevirjem, karbamazepinom, fenitoinom, fenobarbitalom, zaviralci protonske črpalke in buprenorfinom.
English: After mixing the oral powder with food or drinks, it may be stored at room temperature (not above 30oC) for up to 1 hour.
Slovenian: Ko peroralni prašek zmešate s hrano ali napitkom, lahko mešanico shranite pri sobni temperaturi (do 30 oC) za največ 1 uro.
English: Indinavir is associated with indirect unconjugated hyperbilirubinaemia due to inhibition of UGT.
Slovenian: Indinavir je bil povezan z indirektno nekonjugirano hiperbilirubinemijo, ki je bila posledica zaviranja UGT.
English: Co-administration of REYATAZ with ritonavir at doses greater than 100 mg once daily has not been clinically evaluated.
Slovenian: Sočasna uporaba zdravila REYATAZ z ritonavirjem v odmerkih, večjih od 100 mg enkrat na dan, ni klinično ovrednotena.
English: Through 96 weeks of treatment, mean HIV RNA changes from baseline for REYATAZ + ritonavir and lopinavir + ritonavir met criteria for non-inferiority based on observed cases.
Slovenian: Pri 96-tedenskem zdravljenju so srednje spremembe vrednosti HIV RNA od izhodišča za zdravilo REYATAZ + ritonavir in lopinavir + ritonavir zadostile merilom neinferiornosti na podlagi opazovanih primerov.
English: Administration of REYATAZ and infant formula using an infant bottle is not recommended because the full dose may not be delivered.
Slovenian: in začetne formule za dojenčke s pomočjo stekleničke za hranjenje dojenčkov ni priporočljivo, saj otrok morda ne bo zaužil celotnega odmerka.
English: It is not recommended to use REYATAZ with ritonavir for pregnant patients who are receiving both tenofovir disoproxil and an H2-receptor antagonist.
Slovenian: Uporaba zdravila REYATAZ z ritonavirjem ni priporočljiva pri nosečih bolnicah, ki prejemajo tako dizoproksiltenofovirat kot antagonist receptorjev H2.
English: 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.
Slovenian: Ko so manjšo izpostavljenost poskušali nadomestiti z zvečanjem odmerka zdravila REYATAZ ali drugih zaviralcev proteaz v kombinaciji z ritonavirjem, so poročali o večji pogostnosti jetrnih neželenih učinkov.
English: 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.
Slovenian: Izločanje: po enkratnem 400-mg odmerku s 14C-označenega atazanavirja se je 79% radioaktivnosti pojavilo v blatu in 13% v urinu.
English: The clinical data derived from this study are inadequate to support the use of atazanavir capsules (with or without ritonavir) in children below 6 years of age.
Slovenian: Klinični podatki iz te študije niso zadostni, da bi podprli uporabo atazanavirja v obliki kapsul (z ali brez ritonavirja) pri otrocih, mlajših od 6 let.
English: Four subjects in the unboosted REYATAZ group and 2 in the REYATAZ + ritonavir group had HIV RNA > 500 copies/ml during the maintenance phase.
Slovenian: Štirje bolniki v skupini z zdravilom REYATAZ brez okrepitve in 2 bolnika v skupini z zdravilom REYATAZ + ritonavir so med vzdrževalnim obdobjem zdravljenja imeli vrednost HIV RNA > 500 kopij/ml.
English: 100 mgc aEach sachet contains 50 mg of REYATAZ bRitonavir oral solution cRitonavir oral solution or capsule/tablet
Slovenian: 100 mgc aEna vrečica vsebuje 50 mg zdravila REYATAZ bRitonavir v obliki peroralne raztopine cRitonavir v obliki peroralne raztopine ali kapsule/tablete
English: Particular caution should be used when prescribing REYATAZ in association with medicinal products which have the potential to increase the QT interval and/or in patients with preexisting risk factors (bradycardia, long congenital QT, electrolyte imbalances (see sections 4.8 and 5.3).
Slovenian: Posebna previdnost je potrebna pri predpisovanju zdravila REYATAZ skupaj z zdravili, ki lahko podaljšajo interval QT, in/ali pri bolnikih z že obstoječimi dejavniki tveganja (bradikardija, prirojeno podaljšanje intervala QT, neravnovesje elektrolitov) (glejte poglavji 4.8 in 5.3).
English: If you have any questions on how to prepare or give a dose of REYATAZ oral powder, talk to your doctor, pharmacist or nurse.
Slovenian: Če imate glede priprave ali dajanja zdravila REYATAZ peroralni prašek kakršno koli vprašanje, se posvetujte z zdravnikom, s farmacevtom ali z medicinsko sestro.
English: Place the syringe in your child's mouth towards the cheek and push the plunger down to release the medicine.
Slovenian: Brizgo namestite otroku v usta in jo usmerite proti licu ter s pritiskom na bat iztisnite zdravilo.
English: SPECIAL STORAGE CONDITIONS Does not require any special storage conditions.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Za shranjevanje zdravila niso potrebna posebna navodila.
English: PHARMACEUTICAL FORM Oral powder
Slovenian: FARMACEVTSKA OBLIKA peroralni prašek
English: The choice of REYATAZ in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient's treatment history (see sections 4.4 and 5.1).
Slovenian: Pri predhodno že zdravljenih odraslih in pediatričnih bolnikih mora izbira zdravila REYATAZ temeljiti na individualnem testiranju virusne odpornosti in na anamnezi bolnikovega zdravljenja (glejte poglavji 4.4 in 5.1).
English: INHALED BETA AGONISTS Salmeterol
Slovenian: INHALACIJSKI AGONISTI ADRENERGIČNIH RECEPTORJEV BETA Salmeterol
English: PULMONARY ARTERIAL HYPERTENSION PDE5 Inhibitors
Slovenian: PLJUČNA ARTERIJSKA HIPERTENZIJA Zaviralci PDE5
English: ANTIPSYCHOTICS Quetiapine
Slovenian: ANTIPSIHOTIKI Kvetiapin
English: REYATAZ oral powder contains :
Slovenian: Zdravilo REYATAZ peroralni prašek vsebuje:
English: Prior to mixing, the sachet is tapped to settle the powder.
Slovenian: Pred pripravo mešanice vrečico stresite, da se prašek sesede.
English: In clinical studies AI424-397 and AI424-451, paediatric patients 3 months to less than 11 years of age had a mean duration of treatment with REYATAZ oral powder of 80 weeks.
Slovenian: V kliničnih študijah AI424-397 in AI424-451 je zdravljenje pediatričnih bolnikov, starih od 3 mesece do manj kot 11 let, z zdravilom REYATAZ v obliki peroralnega praška v povprečju trajalo 80 tednov.
English: Administration of REYATAZ with ritonavir with either a light or a high-fat meal decreased the coefficient of variation of AUC and Cmax by approximately 25% compared to the fasting state.
Slovenian: Pri uporabi zdravila REYATAZ z ritonavirjem skupaj z obrokom, bodisi lahkim, bodisi bogatim z maščobami, se je koeficient variacije AUC in Cmax zmanjšal za približno 25% v primerjavi z uporabo na tešče.
English: The entire dosage of REYATAZ oral powder (mixed in the liquid infant formula, beverage or food) is administered within one hour of preparation (the mixture can be left at room stored at temperatures not above 30°C during this period).
Slovenian: Celotni odmerek zdravila REYATAZ peroralni prašek (zmešan z začetno tekočo formulo za dojenčke, napitkom ali hrano) mora otrok zaužiti v eni uri po pripravi mešanice (ta čas je mešanica lahko shranjena pri sobni temperaturi do 30 °C).
English: Ritonavir may decrease plasma levels of phenytoin and/or phenobarbital due to CYP2C9 and CYP2C19 induction.
Slovenian: Ritonavir lahko zaradi indukcije CYP2C9 in CYP2C19 zmanjša vrednosti fenitoina in/ali fenobarbitala v plazmi.
English: e Number of patients evaluable.
Slovenian: e Število ovrednotenih bolnikov.
English: c Ritonavir oral solution.
Slovenian: c Ritonavir peroralna raztopina.
English: Antiretroviral treatment experienced adult patients In antiretroviral treatment experienced patients from Studies 009, 043, and 045, 100 isolates from patients designated as virological failures on therapy that included either atazanavir, atazanavir + ritonavir, or atazanavir + saquinavir were determined to have developed resistance to atazanavir.
Slovenian: Odrasli bolniki, ki so se predhodno že zdravili s protiretrovirusnimi zdravili Pri bolnikih v študijah 009, 043 in 045, ki so se predhodno že zdravili s protiretrovirusnimi zdravili, so pojav odpornosti proti atazanavirju odkrili pri 100 izolatih bolnikov z ugotovljeno virološko odpovedjo ob terapiji, ki je vključevala atazanavir, atazanavir + ritonavir ali atazanavir + sakvinavir.
English: f Number of patients evaluable.
Slovenian: f Število ovrednotenih bolnikov.
English: Overall in this study, 182 paediatric patients (81 antiretroviral-naive and 101 antiretroviral-experienced) received once daily REYATAZ (capsule or powder formulation), with or without ritonavir, in combination with two NRTIs.
Slovenian: Skupaj je v tej študiji 182 pediatričnih bolnikov (81 jih še ni prejemalo protiretrovirusnih zdravil, 101 bolnik pa je protiretrovirusna zdravila že jemal) prejemalo zdravilo REYATAZ enkrat na dan (v obliki kapsul ali praška), z ali brez ritonavirja, v kombinaciji z dvema NRTI-jema.
English: Patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucrase isomaltase insufficiency should not take this medicine.
Slovenian: Bolniki z redko dedno intoleranco za fruktozo, malabsorpcijo glukoze/galaktoze ali pomanjkanjem saharoza-izomaltaze ne smejo jemati tega zdravila.
English: Eleven subjects (13%) in the unboosted REYATAZ group and 6 (7%) in the REYATAZ + ritonavir group, had virologic rebound.
Slovenian: Pri 11 bolnikih (13%) v skupini z zdravilom REYATAZ brez okrepitve in 6 bolnikih (7%) v skupini z zdravilom REYATAZ + ritonavir je prišlo do virusnega rebounda.
English: REYATAZ oral powder contains aspartame as a sweetening agent.
Slovenian: Zdravilo REYATAZ peroralni prašek vsebuje sladilo aspartam.
English: postpartuma (n=36)
Slovenian: Po porodua (n=36)
English: The child is to drink the entire residual mixture.
Slovenian: Otrok naj izpije še vso preostalo mešanico.
English: grazoprevir-containing products, including elbasvir/grazoprevir fixed dose combination, and glecaprevir/pibrentasvir fixed dose combination (used to treat chronic hepatitis C infection)
Slovenian: zdravila, ki vsebujejo grazoprevir, vključno s fiksno kombinacijo elbasvir/grazoprevir in fiksno kombinacijo glecaprevir/pibrentasvir (uporabljajo se za zdravljenje kronične okužbe z virusom hepatitisa C).
English: 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).
Slovenian: V primeru odtegnitve ritonavirja iz priporočenega začetnega režima zdravljenja, okrepljenega z ritonavirjem (glejte poglavje 4.4), se pri bolnikih z blago okvaro jeter zdravilo REYATAZ brez okrepitve farmakokinetike lahko nadalje uporablja v odmerku 400 mg, pri bolnikih z zmerno okvaro jeter pa v zmanjšanem odmerku 300 mg enkrat na dan skupaj s hrano (glejte poglavje 5.2).
English: SPECIAL STORAGE CONDITIONS Bottle pack:
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Pakiranje v plastenki:
English: REYATAZ/ritonavir should be administered 2 hours before or 1 hour after antacids or buffered medicinal products.
Slovenian: REYATAZ/ritonavir je treba uporabljati 2 uri pred ali 1 uro po uporabi antacida ali zdravila, ki vsebuje pufer.