FrancophonIA/ELRC3.0 huggingface dataset:
English: Among patients who received REYATAZ 400 mg once daily or REYATAZ 300 mg with ritonavir 100 mg once daily, the only adverse reactions of any severity reported very commonly with at least a possible relationship to regimens containing REYATAZ and one or more NRTIs were nausea (20%), diarrhoea (10%), and jaundice (13%).
Slovenian: Pri bolnikih, ki so prejemali zdravilo REYATAZ v odmerku 400 mg enkrat na dan ali zdravilo REYATAZ v odmerku 300 mg skupaj z ritonavirjem v odmerku 100 mg enkrat na dan, so bili kot zelo pogosti opisani le naslednji neželeni učinki vseh jakosti, ki bi vsaj lahko bili povezani z uporabo zdravila REYATAZ v kombinaciji z enim nukleozidnim/nukleotidnim zaviralcem reverzne transkriptaze (NRTI) ali več: navzea (20%), driska (10%) in zlatenica (13%).
English: ANTIBIOTICS Clarithromycin 500 mg twice daily (atazanavir 400 mg once daily)
Slovenian: ANTIBIOTIKI Klaritromicin 500 mg dvakrat na dan (atazanavir 400 mg enkrat na dan)
English: Each capsule of REYATAZ 300 mg contains 300 mg atazanavir.
Slovenian: Ena kapsula zdravila REYATAZ 300 mg vsebuje 300 mg atazanavirja.
English: Three of 20 infants (15%) born to women treated with REYATAZ/ritonavir 300/100 mg and four of 20 infants (20%) born to women treated with REYATAZ/ritonavir 400/100 mg experienced grade 3-4 bilirubin.
Slovenian: Pri treh od 20 dojenčkov (15%) katerih matere so se zdravile z zdravilom REYATAZ/ritonavirjem v odmerku 300/100 mg in pri štirih od 20 dojenčkov (20%), ki so se rodili materam, ki so se zdravile z zdravilom REYATAZ/ritonavirjem v odmerku 400/100 mg, so poročali o vrednosti bilirubina stopnje 3-4.
English: Excipient with known effect: 109.57 mg of lactose per capsule.
Slovenian: Pomožna snov z znanim učinkom: 109,57 mg laktoze na kapsulo.
English: Blister pack: 30 hard capsules
Slovenian: Pakiranje v pretisnem omotu: 30 trdih kapsul
English: It should be ensured that the patient eats or drinks all the infant formula, beverage or food that contains the powder.
Slovenian: Poskrbite, da bo otrok zaužil celotno količino začetne tekoče formule za dojenčke, napitka ali hrane, ki vsebuje prašek.
English: ≥ 200 cells/mm3
Slovenian: ≥ 200 celic/mm
English: Paediatric patients (at least 3 months of age and weighing at least 5 kg): REYATAZ oral powder is available for paediatric patients at least 3 months of age and weighing at least 5 kg (see Summary of Product Characteristics for REYATAZ oral powder).
Slovenian: Pediatrični bolniki (stari najmanj 3 mesece in s telesno maso najmanj 5 kg): Za pediatrične bolnike, stare najmanj 3 mesece in s telesno maso najmanj 5 kg, je zdravilo REYATAZ na voljo v obliki peroralnega praška (glejte povzetek glavnih značilnosti zdravila REYATAZ peroralni prašek).
English: Co-administration of lurasidone with REYATAZ is contrandicated as this may increase lurasidone-related toxicity (see section 4.3).
Slovenian: Sočasna uporaba lurasidona z zdravilom REYATAZ je kontraindicirana, saj lahko zdravilo REYATAZ okrepi toksične učinke lurasidona (glejte poglavje 4.3).
English: Other side effects reported for patients treated with REYATAZ are the following: Common (may affect up to 1 in 10 people): headache vomiting, diarrhoea, abdominal pain (stomach pain of discomfort), nausea, dyspepsia (indigestion) fatigue (extreme tiredness)
Slovenian: Pri bolnikih, ki so se zdravili z zdravilom REYATAZ, so poročali še o naslednjih neželenih učinkih: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): glavobol; bruhanje, driska, bolečine v trebuhu (bolečine ali neugodje v želodcu), siljenje na bruhanje, dispepsija (prebavne motnje); izčrpanost (močna utrujenost).
English: Blister pack: 60 hard capsules
Slovenian: Pakiranje v pretisnem omotu: 60 trdih kapsul
English: Carbamazepine should be used with caution in combination with REYATAZ.
Slovenian: Karbamazepin je treba v kombinaciji z zdravilom REYATAZ uporabljati previdno.
English: Co-administration of REYATAZ/ritonavir and these glucocorticoids is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.4).
Slovenian: Sočasne uporabe zdravila REYATAZ/ritonavirja in teh glukokortikoidov ne priporočamo, razen v primerih, ko možne koristi zdravljenja prevladajo nad tveganjem za pojav sistemskih kortikosteroidnih učinkov (glejte poglavje 4.4).
English: White ink containing: shellac, titanium dioxide (E171), ammonium hydroxide, propylene glycol and simethicone
Slovenian: Belo črnilo vsebuje: šelak, titanov dioksid (E171), amonijev hidroksid, propilenglikol in simetikon.
English: Tenofovir disoproxil fumarate AUC Tenofovir disoproxil fumarate Cmax Tenofovir disoproxil fumarate Cmin
Slovenian: Dizoproksiltenofovirijev fumarat AUC ↑37% Dizoproksiltenofovirijev fumarat Cmax ↑34% Dizoproksiltenofovirijev fumarat Cmin ↑29%
English: Belgique/België/Belgien N.V. Bristol-Myers Squibb Belgium S.A. Tél/Tel: + 32 2 352 76 11
Slovenian: Bristol-Myers Squibb Belgium S.A. Tél/Tel: + 32 2 352 76 11
English: Nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) Lamivudine 150 mg twice daily + zidovudine 300 mg twice daily (atazanavir 400 mg once daily)
Slovenian: Nukleozidni/nukleotidni zaviralci reverzne transkriptaze (NRTI-ji) Lamivudin 150 mg dvakrat na dan + zidovudin 300 mg dvakrat na dan (atazanavir 400 mg enkrat na dan)
English: The use of REYATAZ in children less than 3 months of age and weighing less than 5 kg has not been studied due to the risk of serious complications.
Slovenian: Tega zdravila ne smete dajati otrokom, mlajšim od 3 mesecev in s telesno maso, manjšo od 5 kg. Uporabe zdravila REYATAZ pri otrocih, mlajših od 3 mesecev in s telesno maso, manjšo od 5 kg, zaradi tveganja za pojav resnih zapletov niso raziskovali.
English: Skin rash, itching that may occasionally be severe has been reported.
Slovenian: Poročali so o kožnem izpuščaju in srbenju, ki je včasih lahko hudo.
English: Not applicable.
Slovenian: priporočljiva.
English: Clarithromycin AUC ↑94% (↑75% Clarithromycin Cmax ↑50% (↑32% Clarithromycin Cmin ↑160% (↑135%
Slovenian: Klaritromicin AUC ↑94% (↑75% ↑116%) Klaritromicin Cmax ↑50% (↑32% ↑71%) Klaritromicin Cmin ↑160% (↑135% ↑188%)
English: Co-administration with REYATAZ has the potential to increase or decrease warfarin concentrations.
Slovenian: Pri sočasni uporabi zdravila REYATAZ se koncentracije varfarina lahko povečajo ali zmanjšajo.
English: REYATAZ/ritonavirb (300 mg/100 mg once daily) n=440
Slovenian: REYATAZ/ritonavirb (300 mg/100 mg enkrat na dan) n=440
English: Co-administration of REYATAZ and medicinal products that induce CYP3A4 is not recommended (see sections 4.3 and 4.5).
Slovenian: Zdravila REYATAZ ni priporočljivo uporabljati skupaj z zdravili, ki inducirajo CYP3A4 (glejte poglavji 4.3 in 4.5).
English: The recommended dose of REYATAZ capsules is 300 mg once daily taken with ritonavir 100 mg once daily and with food.
Slovenian: Priporočeni odmerek zdravila REYATAZ je 300 mg enkrat na dan skupaj z ritonavirjem v odmerku 100 mg enkrat na dan in skupaj s hrano.
English: Patients with moderate to severe hepatic insufficiency (see sections 4.2 and 4.4).
Slovenian: Bolniki z zmerno do hudo insuficienco jeter (glejte poglavji 4.2 in 4.4).
English: LPV/RTVc (400 mg/ 100 mg twice daily) n=123
Slovenian: LPV/RTVc (400 mg/ 100 mg dvakrat na dan) n=123
English: Patients should not breast-feed while taking REYATAZ.
Slovenian: Bolnice med zdravljenjem z zdravilom REYATAZ ne smejo dojiti.
English: In repeat-dose toxicity studies, conducted in mice, rats, and dogs, atazanavir-related findings were generally confined to the liver and included generally minimal to mild increases in serum bilirubin and liver enzymes, hepatocellular vacuolation and hypertrophy, and, in female mice only, hepatic singlecell necrosis.
Slovenian: Obsegale so na splošno minimalno do blago zvišanje serumskega bilirubina in jetrnih encimov, vakuolizacijo in hipertrofijo jetrnih celic ter, samo pri mišjih samicah, nekrozo posameznih jetrnih celic.
English: Stevens-Johnson syndrome (SJS), erythema multiforme, toxic skin eruptions and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been reported with the use of REYATAZ (see section 4.4).
Slovenian: Pri bolnikih, ki so se zdravili z zdravilom REYATAZ, so poročali o pojavu Stevens-Johnsonovega sindroma, multiformnega eritema, toksičnih izbruhov na koži in sindroma medikamentoznega izpuščaja z eozinofilijo in s sistemskimi simptomi (glejte poglavje 4.4).
English: Atazanavir (am): 2 hr after omeprazole Atazanavir AUC ↓61% (↓65% ↓55%) Atazanavir Cmax ↓66% (↓62% ↓49%) Atazanavir Cmin ↓65% (↓71% ↓59%)
Slovenian: Atazanavir (dopoldan): 2 uri po omeprazolu Atazanavir AUC ↓61% (↓65% ↓55%) Atazanavir Cmax ↓66% (↓62% ↓49%) Atazanavir Cmin ↓65% (↓71% ↓59%)
English: Elbasvir Cmax: ↑315% (↑246% ↑397%) Elbasvir Cmin: ↑545% (↑451% ↑654%)
Slovenian: Elbasvir AUC: ↑376% (↑307% ↑456%) Elbasvir Cmax: ↑315% (↑246% ↑397%) Elbasvir Cmin: ↑545% (↑451% ↑654%)
English: Co-administration with REYATAZ/ritonavir may cause a large increase in the concentration of these benzodiazepines.
Slovenian: Pri sočasni uporabi zdravila REYATAZ/ritonavirja se lahko koncentracije teh benzodiazepinov močno povečajo.
English: Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4).
Slovenian: Med protiretrovirusnim zdravljenjem se lahko poveča telesna masa ter zviša koncentracija lipidov in glukoze v krvi (glejte poglavje 4.4).
English: If the combination is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of REYATAZ to 400 mg with 100 mg of ritonavir; doses of proton pump inhibitors comparable to omeprazole 20 mg should not be exceeded (see section 4.4).
Slovenian: Če je uporaba kombinacije nujna, je potreben skrben klinični nadzor, odmerek zdravila REYATAZ pa je treba povečati na 400 mg in ga uporabljati skupaj z ritonavirjem v odmerku 100 mg. Odmerkov zaviralcev protonske črpalke, ki so primerljivi z 20 mg omeprazola, se ne sme preseči (glejte poglavje 4.4).
English: Excipient with known effect: 54.79 mg of lactose per capsule.
Slovenian: Pomožna snov z znanim učinkom: 54,79 mg laktoze na kapsulo.
English: Co-administration with REYATAZ may cause a large increase in the concentration of these benzodiazepines.
Slovenian: Pri sočasni uporabi zdravila REYATAZ se lahko koncentracije teh benzodiazepinov močno povečajo.
English: Concomitant use of salmeterol and REYATAZ/ritonavir may result in increased cardiovascular adverse events associated with salmeterol.
Slovenian: Pri sočasni uporabi salmeterola in zdravila REYATAZ/ritonavirja se lahko poveča pojavnost kardiovaskularnih neželenih učinkov salmeterola.
English: Rifabutin AUC ↑48% (↑19% ↑84%) Rifabutin Cmax ↑149% (↑103% ↑206%) Rifabutin Cmin ↑40% (↑5% ↑87%) ** 25-O-desacetyl-rifabutin AUC ↑990% 25-O-desacetyl-rifabutin Cmax ↑677% 25-O-desacetyl-rifabutin Cmin ↑1045%
Slovenian: Rifabutin AUC ↑48% (↑19% ↑84%) ** Rifabutin Cmax ↑149% (↑103% ↑206%) ** Rifabutin Cmin ↑40% (↑5% ↑87%) ** 25-O-dezacetil-rifabutin AUC ↑990% (↑714% 25-O-dezacetil-rifabutin Cmax ↑677% (↑513% 25-O-dezacetil-rifabutin Cmin ↑1.045% (↑715%
English: Each bottle contains 30 hard capsules.
Slovenian: Ena plastenka vsebuje 30 trdih kapsul.
English: Ethinyloestradiol 35 µg + norethindrone (atazanavir 400 mg once daily)
Slovenian: Etinilestradiol 35 µg + noretindron (atazanavir 400 mg enkrat na dan)
English: asthenia (unusual tiredness or weakness) weight decreased, weight gain, anorexia (loss of appetite), appetite increased depression, anxiety, sleep disorder disorientation, amnesia (loss of memory), dizziness, somnolence (sleepiness), abnormal dream syncope (fainting), hypertension (high blood pressure) dyspnoea (shortness of breath) pancreatitis (inflammation of the pancreas), gastritis (inflammation of the stomach), stomatitis aphthous (mouth ulcers and cold sores), dysgeusia (impairment of the sense of taste), flatulence (wind), dry mouth, abdominal distension angioedema (severe swelling of the skin and other tissues most often the lips or the eyes) alopecia (unusual hair loss or thinning), pruritus (itching) muscle atrophy (muscle shrinkage), arthralgia (joint pain), myalgia (aching muscles) interstitial nephritis (kidney inflammation), haematuria (blood in the urine), proteinuria (excess protein in the urine), pollakiuria (increased frequency of urination) gynaecomastia (breast enlargement in men) chest pain, malaise (generally feeling unwell), fever insomnia (difficulty sleeping)
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): periferna nevropatija (odrevenelost, oslabelost, zbadanje ali bolečina v rokah ali nogah); preobčutljivost (alergijska reakcija); astenija (neobičajna utrujenost ali slabotnost); zmanjšanje telesne mase, povečanje telesne mase, anoreksija (izguba apetita), povečanje apetita; depresija, tesnoba, motnje spanja; dezorientiranost, amnezija (izguba spomina), omotica, somnolenca (zaspanost), neobičajne sanje; sinkopa (omedlevica), hipertenzija (visok krvni tlak); dispneja (oteženo dihanje); pankreatitis (vnetje trebušne slinavke), gastritis (vnetje želodca), aftozni stomatitis (razjede in vnetje v ustih), paragevzija (motnje okusa), flatulenca (vetrovi), suha usta, napet trebuh; angioedem (hudo otekanje kože in drugih tkiv, najpogosteje ustnic ali oči); alopecija (neobičajno izpadanje ali redčenje las), pruritus (srbenje); atrofija mišic (zmanjšanje mišične mase), artralgija (bolečina v sklepu), mialgija (bolečine v mišicah); intersticijski nefritis (vnetje ledvic), hematurija (kri v urinu), proteinurija (presežek beljakovin v urinu), polakisurija (pogostejše uriniranje); ginekomastija (povečanje dojk pri moških); bolečine v prsih, splošno slabo počutje, zvišana telesna temperatura; insomnia (nespečnost);
English: No drug interaction study has been performed for the co-administration of REYATAZ/ritonavir with benzodiazepines.
Slovenian: Študije medsebojnega delovanja pri sočasni uporabi zdravila REYATAZ/ritonavirja in benzodiazepinov niso bile izvedene.
English: The combination of rifampicin and REYATAZ with concomitant low-dose ritonavir is contraindicated (see section 4.3).
Slovenian: Sočasna uporaba rifampicina in zdravila REYATAZ skupaj z nizkim odmerkom ritonavirja je kontraindicirana (glejte poglavje 4.3).
English: Take a medicine cup or small container and put the sachets' content in the cup or small container.
Slovenian: Vsebino vrečic stresite v merico za odmerjanje zdravil ali manjšo posodico.
English: For patients not taking tenofovir, if REYATAZ 300 mg/ritonavir 100 mg and H2-receptor antagonists are coadministered, a dose equivalent to famotidine 20 mg twice daily should not be exceeded.
Slovenian: Pri bolnikih, ki se ne zdravijo s tenofovirjem, je treba zdravilo REYATAZ 300 mg z ritonavirjem 100 mg, če se uporablja z antagonistom histaminskih receptorjev H2, le-tega uporabljati v odmerku, ki ne presega odmerka, ekvivalentnega famotidinu 20 mg dvakrat na dan.
English: Table 9: Steady-State Pharmacokinetics of Atazanavir with ritonavir in HIV-Infected Pregnant Women in the Fed State atazanavir 300 mg with ritonavir 100 mg Pharmacokinetic Parameter 2nd Trimester (n=9)
Slovenian: Preglednica 9: Farmakokinetični parametri atazanavirja z ritonavirjem v stanju dinamičnega ravnovesja pri z virusom HIV okuženih nosečnicah pri uporabi skupaj s hrano atazanavir 300 mg z ritonavirjem 100 mg
English: No dosage adjustments are needed for fluconazole and REYATAZ.
Slovenian: Odmerkov flukonazola in zdravila REYATAZ ni treba prilagajati.
English: What REYATAZ contains
Slovenian: Kaj vsebuje zdravilo REYATAZ
English: Table 8: Steady-State Pharmacokinetics of Atazanavir with ritonavir in HIV-Infected Pregnant Women in the Fed State atazanavir 300 mg with ritonavir 100 mg Pharmacokinetic Parameter 2nd Trimester (n=9)
Slovenian: Preglednica 8: Farmakokinetični parametri atazanavirja z ritonavirjem v stanju dinamičnega ravnovesja pri z virusom HIV okuženih nosečnicah pri uporabi skupaj s hrano atazanavir 300 mg z ritonavirjem 100 mg
English: Cmin ng/mLb
Slovenian: Cmin ng/mlb geometrična sredina (KV%)
English: HIV RNA <50 copies/ml by select baseline PI substitutions,f, g % (responder/evaluable) NA
Slovenian: HIV RNA <50 kopij/ml glede na izbrane PI substitucije v izhodiščuf, g % (bolniki z odzivom/ovrednoteno)
English: Lamotrigine should be used with caution in combination with REYATAZ/ritonavir.
Slovenian: Lamotrigin je treba v kombinaciji z zdravilom REYATAZ/ritonavir uporabljati previdno.
English: 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 with concomitant low-dose ritonavir.
Slovenian: Uporaba zaviralcev PDE5 za zdravljenje erektilne disfunkcije: pri bolnikih, ki se zdravijo z zdravilom REYATAZ v kombinaciji z nizkim odmerkom ritonavirja, je potrebna posebna previdnost pri predpisovanju zaviralcev PDE5 (sildenafil, tadalafil ali vardenafil) za zdravljenje erektilne disfunkcije.
English: Co-administration of REYATAZ with grazoprevir-containing products, including elbasvir/grazoprevir fixed dose combination is contraindicated because of the increase in grazoprevir and elbasvir plasma concentrations and potential for the increase in risk of ALT elevations associated with increased grazoprevir concentrations (see section 4.3).
Slovenian: Sočasna uporaba zdravila REYATAZ in zdravil, ki vsebujejo grazoprevir, vključno s fiksno kombinacijo elbasvir/grazoprevir je kontraindicirana zaradi povečanja koncentracij grazoprevirja in elbasvirja v plazmi in možnega večjega tveganja za zvišanje vrednosti ALT, povezanega s povečanimi koncentracijami grazoprevirja (glejte poglavje 4.3).
English: Feed your child with the mixture.
Slovenian: Mešanico dajajte otroku, da jo zaužije.
English: The mechanism of interaction is a reduced solubility of atazanavir with increasing pH related to the presence of anti-acid agent in didanosine buffered tablets.
Slovenian: Mehanizem te interakcije je manjša topnost atazanavirja pri višjem pH-ju zaradi antacidnega sredstva v didanozin pufranih tabletah.
English: Co-administration of diltiazem and REYATAZ/ritonavir has not been studied.
Slovenian: Sočasne uporabe diltiazema in zdravila REYATAZ/ritonavirja niso raziskovali.
English: Before use, tap the sachet.
Slovenian: Pred uporabo vrečico stresite.
English: Stevens-Johnson syndrome (SJS), erythema multiforme, toxic skin eruptions and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been reported in patients receiving REYATAZ.
Slovenian: Pri bolnikih, ki so se zdravili z zdravilom REYATAZ, so poročali o pojavu Stevens-Johnsonovega sindroma, multiformnega eritema, toksičnih izbruhov na koži in sindroma medikamentoznega izpuščaja z eozinofilijo in s sistemskimi simptomi (DRESS; “drug rash with eosinophilia and systemic symptoms”).
English: There are no dosing recommendations for REYATAZ in paediatric patients less than 3 months of age.
Slovenian: Za otroke, mlajše od 3 mesecev, priporočila za odmerjanje zdravila REYATAZ niso na voljo.
English: If the combination of
Slovenian: Če se zdravilo
English: The co-administration of abacavir and REYATAZ is not expected to significantly alter the exposure of abacavir.
Slovenian: Pri sočasni uporabi abakavirja in zdravila REYATAZ pomembnejših sprememb v izpostavljenosti abakavirju ne pričakujemo.
English: Lopinavir/ritonavirc (400 mg/100 mg twice daily) n=443
Slovenian: Lopinavir/ritonavirc (400 mg/100 mg dvakrat na dan) n=443
English: CD4 Mean Change from Baseline, cells/mm3 All patients 110 (n=83) 122 (n=60) 121 (n=94) 154 (n=60)
Slovenian: 110 (n=83) 122 (n=60) 121 (n=94) 154 (n=60)
English: How to take REYATAZ
Slovenian: Kako jemati zdravilo REYATAZ
English: The appropriate option listed below is chosen for mixing and administration with liquid infant formula, beverage or food.
Slovenian: Izberite enega od v nadaljevanju navedenih načinov priprave mešanice in dajanja z začetno tekočo formulo za dojenčke, napitkom ali hrano, ki ustreza otroku.
English: HIV RNA <50 copies/ml by select baseline PI substitutions,c % (responder/evaluabled) NA
Slovenian: HIV RNA <50 kopij/ml glede na izbrane PI substitucije v izhodišču,c % (bolniki z odzivom/ovrednotenod)
English: absence of prior virologic failure undetectable viral load during the last 6 months under current regimen viral strains not harbouring HIV resistance associated mutations (RAMs) to current regimen.
Slovenian: virusni sevi ne vsebujejo mutacij, povezanih z odpornostjo virusa HIV (RAM; “resistance associated mutations”) proti trenutnemu režimu zdravljenja.
English: Capsule shells: gelatine, red iron oxide, black iron oxide, yellow iron oxide, indigocarmin (E132) and titanium dioxide (E171)
Slovenian: Ovojnice kapsul: želatina, rdeči železov oksid, črni železov oksid, rumeni železov oksid, indigotin (E132) in titanov dioksid (E171).
English: Study 045 is a randomised, multicenter trial comparing REYATAZ/ritonavir (300/100 mg once daily) and REYATAZ/saquinavir (400/1,200 mg once daily), to lopinavir + ritonavir (400/100 mg fixed dose combination twice daily), each in combination with tenofovir disoproxil fumarate (see sections 4.5 and 4.8) and one NRTI, in patients with virologic failure on two or more prior regimens containing at least one PI, NRTI, and NNRTI.
Slovenian: Pri odraslih bolnikih, ki so se predhodno že zdravili s protiretrovirusnimi zdravili Študija 045 je randomizirano, multicentrično preskušanje, ki je primerjalo zdravilo REYATAZ/ritonavir (300/100 mg enkrat na dan) in zdravilo REYATAZ/sakvinavir (400/1.200 mg enkrat na dan) z lopinavirjem + ritonavirjem (400/100 mg v fiksni kombinaciji v odmerku dvakrat na dan), vse v kombinaciji z dizoproksiltenofovirijevim fumaratom (glejte poglavji 4.5 in 4.8) in enim NRTI-jem pri bolnikih z virološko neuspešnim zdravljenjem z eno ali več predhodnimi shemami, ki so obsegale vsaj en zaviralec proteaz, NRTI in NNRTI.
English: Combinations of REYATAZ and indinavir have not been studied and co-administration of these medicinal products is not recommended (see section 4.5).
Slovenian: Kombinacija zdravila REYATAZ z indinavirjem ni raziskana, zato sočasna uporaba teh dveh zdravil ni priporočljiva (glejte poglavje 4.5).
English: REYATAZ/ritonavir is coadministered with clarithromycin.
Slovenian: REYATAZ/ritonavir uporablja skupaj s klaritromicinom, je potrebna previdnost.
English: Co-administration of REYATAZ with nevirapine or efavirenz is not recommended (see section 4.5).
Slovenian: Sočasna uporaba zdravila REYATAZ in nevirapina ali efavirenza ni priporočljiva (glejte poglavje 4.5).
English: Diltiazem 180 mg once daily (atazanavir 400 mg once daily)
Slovenian: Diltiazem 180 mg enkrat na dan (atazanavir 400 mg enkrat na dan)
English: Carton Bottle pack (1 bottle): 30 hard capsules Carton Bottle pack: (3 bottles): 3 x 30 hard capsules (3 bottles of 30 hard capsules) Label Bottle pack: 30 hard capsules
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Škatla, pakiranje v plastenki (1 plastenka): 30 trdih kapsul Škatla, pakiranje v plastenki (3 plastenke): 3 x 30 trdih kapsul (3 plastenke po 30 trdih kapsul) Nalepka, pakiranje v plastenki: 30 trdih kapsul
English: Sofosbuvir 400 mg / velpatasvir 100 mg / voxilaprevir 100 mg single dose* (atazanavir 300 mg / ritonavir 100 mg once daily)
Slovenian: Sofosbuvir 400 mg / velpatasvir 100 mg / voksilaprevir 100 mg enkratni odmerek* (atazanavir 300 mg / ritonavir 100 mg enkrat na dan)
English: No drug interaction study has been performed for the coadministration of REYATAZ with benzodiazepines.
Slovenian: Študije medsebojnega delovanja pri sočasni uporabi zdravila REYATAZ in benzodiazepinov niso bile izvedene.
English: Either one or three bottles of 30 hard capsules are provided in one carton.
Slovenian: Ena škatla vsebuje eno ali tri plastenke s 30 trdimi kapsulami.
English: Voriconazole AUC ↑561% (↑451% Voriconazole Cmax ↑438% (↑355% Voriconazole Cmin ↑765% (↑571%
Slovenian: Vorikonazol AUC ↑561% (↑451% ↑699%) Vorikonazol Cmax ↑438% (↑355% ↑539%) Vorikonazol Cmin ↑765% (↑571% ↑1,020%)