natgillin/translations-raw huggingface dataset:
Concentrations of these immunosuppressants may be increased when co-administered with REYATAZ/ritonavir due to CYP3A4 inhibition.
Koncentracije ovih imunosupresiva mogu biti povišene kad se primjenjuju istovremeno s lijekom REYATAZ/ritonavirom zbog inhibicije CYP3A4.
Haemophiliac patients: There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthroses, in type A and B haemophiliac patients treated with protease inhibitors.
Bolesnici s hemofilijom: U osoba s hemofilijom A i B liječenih inhibitorima proteaze zabilježeni su slučajevi pojačanog krvarenja, uključujući spontani nastanak kožnih hematoma i hemartroze.
Co-administration of voriconazole and REYATAZ with ritonavir is not recommended, unless an assessment of the benefit/risk justifies the use of voriconazole.
Ne preporučuje se istovremena primjena vorikonazola i lijeka REYATAZ s ritonavirom, osim ako procjena omjera koristi i rizika opravdava primjenu vorikonazola.
ANTIFUNGALS Ketoconazole 200 mg once daily (atazanavir 400 mg once daily)
ANTIMIKOTICI Ketokonazol 200 mg jedanput na dan (atazanavir 400 mg jedanput na dan)
It inhibits CYP3A4.
CYP3A4.
Co-administration of REYATAZ/ritonavir with quetiapine is contraindicated as may increase quetiapine-related toxicity.
Istodobna primjena kvetiapina i lijeka REYATAZ/ritonavira je kontraindicirana jer REYATAZ može povećati toksičnost povezanu s primjenom kvetiapina.
Either one or three bottles of 30 hard capsules are provided in one carton.
U jednoj kutiji nalazi se jedna ili tri bočice svaka s 30 tvrdih kapsula.
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
HIV RNK <400 kopija/ml, %a Najmanje 5 do < 10 kg (REYATAZ 150 i 200 mg)
Concentrations of these immunosuppressants may be increased when co-administered with REYATAZ due to CYP3A4 inhibition.
Koncentracije ovih imunosupresiva mogu biti povišene kad se primjenjuju istovremeno s lijekom REYATAZ zbog inhibicije CYP3A4.
No dosage adjustments are needed for REYATAZ/ritonavir and fluconazole.
Nisu potrebne prilagodbe doze flukonazola i lijeka REYATAZ/ritonavira.
200 mg (4 sachetsa)
200 mg (4 vrećicaa)
REYATAZ is contraindicated in patients with severe hepatic insufficiency (see sections 4.2, 4.4 and 5.2).
REYATAZ je kontraindiciran u bolesnika s teškom insuficijencijom jetre (vidjeti dijelove 4.2, 4.4 i 5.2).
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.
Istovremena primjena lijeka REYATAZ s ritonavirom i druge hormonske ili oralne kontracepcije koja sadrži progestagene, osim norgestimata, nije ispitana i stoga je treba izbjegavati.
The dose and the number of REYATAZ oral powder sachets needed is determined based on weight (see section 4.2.
Upute za uporabu Doza i broj potrebnih vrećica s REYATAZ oralnim praškom određuje se prema tjelesnoj težini (vidjeti dio 4.2.) 1. Prije miješanja vrećicu treba protresti da bi se prašak slegao.
Bepridil
OPIOIDI
Nephrolithiasis has been reported in patients receiving REYATAZ (see section 4.8).
U bolesnika koji primaju REYATAZ zabilježena je nefrolitijaza (vidjeti dio 4.8).
REYATAZ with ritonavir has not been studied in patients with hepatic impairment.
REYATAZ s ritonavirom nije ispitan u bolesnika s oštećenjem funkcije jetre.
Treatment-Naive REYATAZ Powder/ritonavir n=52
Boelesnici koji prethodno nisu bili liječeni s REYATAZ oralnim prašakom /ritonavirom n=52
300 mg tenofovir disoproxil fumarate is equivalent to 245 mg tenofovir disoproxil.
S tenofovirdizoproksilfumaratom od 300 mg jedanput na dan (što odgovara 245 mg tenofoviridizoproksila)
The co-administration of REYATAZ/ ritonavir with abacavir is not expected to significantly alter the exposure of abacavir.
Ne očekuje se da će istovremena primjena abakavira i lijeka REYATAZ/ritonavir značajno promijeniti izloženost abakaviru.
Gallbladder problems uncommonly happen in people taking REYATAZ.
Manje često mogu se pojaviti problemi sa žučnim kamencima u osoba koje uzimaju lijek REYATAZ.
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.
U odraslih bolesnika koji su prethodno bili liječeni antiretrovirusnim lijekovima Ispitivanje 045 randomizirano je, multicentrično ispitivanje u kojem su REYATAZ/ritonavir (300/100 mg jedanput na dan) i REYATAZ/sakvinavir (400/1200 mg jedanput na dan) uspoređivani s lopinavirom + ritonavirom (400/100 mg, fiksna kombinacija doza, dvaput na dan), a svaka se od tih terapija primjenjivala u kombinaciji s tenofovirdizoproksilfumaratom (vidjeti dijelove 4.5 i 4.8) i jednim NRTI-jem u bolesnika u kojih je dva ili više prethodnih protokola s najmanje jednim inhibitorom proteaze, NRTI-jem i NNRTI-jem bilo virološki neuspješno.
REYATAZ 150 mg hard capsules
REYATAZ 150 mg tvrde kapsule
250 mg (5 sachetsb)
250 mg (5 vrećicaa)
HIV RNA <400 copies/ml, % a All patients
HIV RNK <400 kopija/ml, % a Svi bolesnici
HIV RNA <50 copies/ml by select baseline PI substitutions,c % (responder/evaluabled) NA
HIV RNK <50 kopija/ml prema početnim odabranim supstitucijama za rezistenciju na inhibitor proteaze,c % (bolesnici s odgovorom/bolesnici koje se moglo procijenitid)
Patients should be closely monitored for tenofovir disoproxil-associated adverse reactions, including renal disorders.
Bolesnike treba pažljivo nadzirati zbog nuspojava tenofovira uključujući poremećaje bubrega.
SPECIAL STORAGE CONDITIONS Bottle pack:
POSEBNE MJERE ČUVANJA Pakiranje s bocom
How to take REYATAZ 4.
3. Kako uzimati REYATAZ
Chronic kidney disease in HIV-infected patients treated with atazanavir, with or without ritonavir, has been reported during postmarketing surveillance.
Tijekom praćenja nakon stavljanja u promet, prijavljena je kronična bubrežna bolest u bolesnika zaraženih HIV-om, liječenih atazanavirom, sa ili bez ritonavira.
Co-administration with REYATAZ may result in increased concentrations of the PDE5 inhibitor and an increase in PDE5-inhibitor-associated adverse events.
Istovremena primjena s lijekom REYATAZ može rezultirati povišenim koncentracijama inhibitora PDE5 i pojačanim nuspojavama povezanima s inhibitorom PDE5.
NAME OF THE MEDICINAL PRODUCT REYATAZ 50 mg oral powder atazanavir
NAZIV LIJEKA REYATAZ 50 mg oralni prašak atazanavir
Either one or three bottles of 60 hard capsules are provided in one carton.
U jednoj kutiji nalazi se jedna ili tri bočice svaka sa 60 tvrdih kapsula.
Didanosine (enteric coated capsules) 400 mg single dose (atazanavir 300 mg once daily with ritonavir 100 mg once daily)
Didanozin (želučanootporne kapsule) 400 mg, jednokratna doza (atazanavir 300 mg jedanput na dan s ritonavirom 100 mg jedanput na dan)
Co-administration of REYATAZ/ritonavir and indinavir is not recommended (see section 4.4).
REYATAZ/ritonavira i indinavira (vidjeti dio 4.4).
The Summary of Product Characteristics for ritonavir must be consulted before initiation of therapy with REYATAZ and ritonavir.
Prije početka terapije lijekom REYATAZ i ritonavirom potrebno je pročitati Sažetak opisa svojstava lijeka za ritonavir.
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.
U otvorenom, randomiziranom, usporednom ispitivanju provedenom nakon 26 do 30 tjednog uvodnog liječenja lijekom REYATAZ u dozi od 300 mg + ritonavirom u dozi od 100 mg jedanput na dan i dvama NRTI-ma u ispitanika s HIV infekcijom i potpuno suprimiranom replikacijom HIV-a, kombinacija nepojačanog lijeka REYATAZ u dozi od 400 mg jedanput na dan i dvaju NRTI-ja tijekom 48-tjedne faze održavanja (n=87) postigla je sličnu antivirusnu djelotvornost kao i REYATAZ
Ritonavir is administered immediately following REYATAZ powder administration.
5. Ritonavir se primjenjuje odmah nakon primjene REYATAZ praška.
Study 138 is an international randomised, open-label, multicenter, prospective trial of 883 antiretroviral treatment naive patients comparing REYATAZ/ritonavir (300 mg/100 mg once daily) to lopinavir/ritonavir (400 mg/100 mg twice daily), each in combination with fixed dose tenofovir disoproxil fumarate/emtricitabine (300 mg/200 mg tablets once daily).
U odraslih bolesnika koji prethodno nisu bili liječeni antiretrovirusnim lijekovima Ispitivanje 138 međunarodno je, randomizirano, multicentrično, prospektivno ispitivanje otvorenog tipa u 883 bolesnika koji prethodno nisu bili liječeni antiretrovirusnim lijekovima, u kojem se REYATAZ/ritonavir (300 mg/100 mg jedanput na dan) uspoređivao s lopinavirom/ritonavirom (400 mg/100 mg dvaput na dan), gdje su obje te kombinacije bile davane zajedno s fiksnom dozom tenofovirdizoprokislfumarata/emtricitabina (300 mg/200 mg tablete, jedanput na dan).
Carbamazepine should be used with caution in combination with REYATAZ/ritonavir.
Karbamazepin se mora primjenjivati uz oprez u kombinaciji s lijekom REYATAZ/ritonavirom.
Co-administration of REYATAZ/ritonavir with products containing St. John's wort is contraindicated.
Istovremena primjena lijeka REYATAZ/ritonavira i proizvoda koji sadrže gospinu travu je kontraindicirana.
Proton pump inhibitors Omeprazole 40 mg once daily (atazanavir 400 mg once daily with ritonavir 100 mg once daily)
Inhibitori protonske pumpe Omeprazol 40 mg jedanput na dan (atazanavir 400 mg jedanput na dan s ritonavirom 100 mg jedanput na dan)
Co-administration of REYATAZ and indinavir is not recommended (see section 4.4).
Ne preporučuje se istovremena primjena lijeka REYATAZ i indinavira (vidjeti dio 4.4).
Atazanavir (am): 2 hr after omeprazole Atazanavir AUC ↓61% (↓65% ↓55%) Atazanavir Cmax ↓66% (↓62% ↓49%) Atazanavir Cmin ↓65% (↓71% ↓59%)
Atazanavir AUC ↓61% (↓65% ↓55%) Atazanavir Cmax ↓66% (↓62% ↓49%) Atazanavir Cmin ↓65% (↓71% ↓59%)
The capsule shell and printing ink contain gelatine, shellac, ammonium hydroxide, simethicone, red iron oxide, black iron oxide, yellow iron oxide, propylene glycol, indigocarmin (E132) and titanium dioxide (E171).
Ovojnica kapsule i tinta za označivanje sadrže želatinu, šelak, amonijev hidroksid, simetikon, crveni željezov oksid, crni željezov oksid, žuti željezov oksid, propilenglikol, indigokarmin (E132) i titanijev dioksid (E171).
Concomitant use of salmeterol and REYATAZ may result in increased cardiovascular adverse events associated with salmeterol.
Istovremena primjena salmeterola i lijeka REYATAZ može rezultirati pojačanim kardiovaskularnim nuspojavama salmeterola.
Lamotrigine should be used with caution in combination with REYATAZ/ritonavir.
Lamotrigin se mora primjenjivati uz oprez u kombinaciji s lijekom REYATAZ i ritonavirom.
Switching from REYATAZ oral powder to REYATAZ capsules is encouraged as soon as patients are able to consistently swallow capsules.
Preproručuje se prijelaz s REYTAZ oralnog praška na REYATAZ kapsule čim su bolesnici mogu pozdanno progutati kapsule.
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).
Istodobna primjena lijeka REYATAZ s lijekovima koji sadrže grazoprevir, uključujući fiksnu kombinaciju elbasvir/grazoprevir kontraindicirana je zbog povišene koncentracije grazoprevira i elbasvira i postoji rizik povišenja vrijednosti ALT-a zbog povećane koncentracije grazoprevira (vidjeti dio 4.3).
HCV Protease Inhibitors Boceprevir 800 mg three times daily (atazanavir 300 mg/ritonavir 100 mg once daily)
Inhibitori proteaze HCV-a Boceprevir 800 mg triput na dan (atazanavir 300 mg/ritonavir 100 mg jedanput na dan)
CD4 Mean Change from Baseline, cells/mm3 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
CD4 prosječna promjena od početne vrijednosti, stanice/mm3 Najmanje 5 do < 10 kg (REYATAZ 150 and 200 mg)
Ritonavir is used as a booster of atazanavir pharmacokinetics (see sections 4.5 and 5.1).
Ritonavir se koristi kao pojačivač farmakokinetike atazanavira (vidjeti dijelove 4.5 i 5.1). (Vidjeti i "Prekid primjene ritonavira samo pod restriktivnim uvjetima" u dijelu 4.4).
Kidney stones uncommonly happen in people taking REYATAZ.
Manje često mogu se pojaviti bubrežni kamenci u osoba koje uzimaju REYATAZ.
Hyperbilirubinaemia (an increase in the level of bilirubin in the blood) has occurred in patients receiving REYATAZ.
U bolesnika koji uzimaju REYATAZ može nastati hiperbilirubinemija (povišena razina bilirubina u krvi).
Your doctor will evaluate how severe your liver disease is before deciding whether you can take REYATAZ if you are taking any of these medicines: see also Other medicines and REYATAZ rifampicin (an antibiotic used to treat tuberculosis) astemizole or terfenadine (commonly used to treat allergy symptoms, these medicines may be available without prescription); cisapride (used to treat gastric reflux, sometimes called heartburn); pimozide (used to treat schizophrenia); quinidine or bepridil (used to correct heart rhythm); ergotamine, dihydroergotamine, ergonovine, methylergonovine (used to treat headaches); and alfuzosin (used to treat enlarged prostatic gland) quetiapine (used to treat schizophrenia, bipolar disorder and major depressive disorder); lurasidone (used to treat schizophrenia) medicines containing St. John's wort (Hypericum perforatum, a herbal preparation)
Liječnik će procijeniti koliko je teška Vaša bolest jetre prije nego što odluči možete li uzimati REYATAZ ako uzimate neki od ovih lijekova: vidjeti također Drugi lijekovi i REYATAZ rifampicin,(antibiotik za liječenje tuberkuloze) astemizol ili terfenadin (obično se primjenjuju za liječenje simptoma alergije i mogu se nabaviti bez recepta); cisaprid (primjenjuje se za liječenje želučanog refluksa, tj. žgaravice); pimozid (primjenjuje se za liječenje shizofrenije); kinidin ili bepridil (primjenjuju se za liječenje poremećaja srčanog ritma); ergotamin, dihidroergotamin, ergonovin, metilergonovin (primjenjuju se za liječenje glavobolje); i alfuzosin (primjenjuje se za liječenje povećanja prostate) kvetiapin (primjenjuje se za liječenje shizofrenije, bipolarnog poremećaja i velikog depresivnog poremećaja), lurasidon (primjenjuje se za liječenje shizofrenije) lijekove koji sadrže gospinu travu (Hypericum perforatum, biljni pripravak)
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava:navedenog u Dodatku V.
uncommon: gynaecomastia
manje često: ginekomastija
Coadministration with REYATAZ may result in increased concentrations of the PDE5 inhibitor and an increase in PDE5-associated adverse events, including hypotension, visual changes, and priapism.
REYATAZ može rezultirati povišenim koncentracijama inhibitora PDE5 i pojačanim nuspojavama povezanima s PDE5, uključujući hipotenziju, poremećaje vida i prijapizam.
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)
Manje često (mogu se javiti u do 1 na 100 osoba): periferna neuropatija (utrnulost, slabost, trnci ili bol u rukama i nogama) preosjetljivost (alergijska reakcija) astenija (neobičan umor ili slabost) smanjenje tjelesne težine, povećanje tjelesne težine, anoreksija (gubitak apetita), pojačan apetit depresija, tjeskoba, poremećaj spavanja dezorijentacija, amnezija (gubitak pamćenja), omaglica, somnolencija (izrazita pospanost), abnormalni snovi sinkopa (nesvjestica), hipertenzija (povišeni krvni tlak) otežano disanje (nedostatak zraka) pankreatitis (upala gušterače), gastritis (upala želuca), aftozni stomatitis (ranice u ustima i groznica na usnama), disgeuzija (promjene osjeta okusa), flatulencija (vjetrovi), suha usta, rastezanje trbuha angioedem (teško oticanje kože i drugih tkiva, najčešće usana i očiju) alopecija (neobičan gubitak ili prorijeđenost kose), pruritus (svrbež) mišićna atrofija (gubitak mišića), artralgija (bol u zglobovima), mialgija (bol u mišićima) nefrolitijaza (stvaranje bubrežnih kamenaca), intersticijalni nefritis (upala bubrega), hematurija (krv u mokraći), proteinurija (višak proteina u mokraći), polakizurija (učestalo mokrenje) ginekomastija (povećanje grudi u muškaraca) bol u prsištu, malaksalost (opće loše stanje), vrućica nesanica (poteškoće sa spavanjem)
TreatmentExperienced REYATAZ Capsules/ritonavir (300 mg/100 mg once daily) n=25
Bolesnici koji su prethodno bili liječeni REYATAZ kapsulama i ritonavirom (300 mg/100 mg jedanput na dan) n=25
Immune system disorders:
Poremećaji probavnog sustava:
Co-administration of lamotrigine and REYATAZ/ritonavir may decrease lamotrigine plasma concentrations due to UGT1A4 induction.
Zbog indukcije UGT1A4, istodobna primjena lamotrigina i lijeka REYATAZ s ritonavirom može sniziti koncentracije lamotrigina u plazmi.
No dose adjustment is needed for REYATAZ/ritonavir.
Nije potrebna prilagodba doze lijeka REYATAZ/ritonavira.
In antiretroviral experienced adult patients
Antiretrovirusno liječenje odraslih bolesnika koji prethodno nisu bili liječeni
Switching to REYATAZ capsules from REYATAZ oral powder is encouraged as soon as patients are able to consistently swallow capsules.
Preporučuje se prijelaz na REYATAZ kapsule s REYATAZ oralnog praška čim bolesnici mogu pouzdano progutati kapsule.
HIV RNA <50 copies/ml, % All patientsd
HIV RNK <50 kopija/ml, % Svi bolesnicid
At least 15 to less than 35
Najmanje 15 do manje od 35
300 mg (6 sachetsb)
300 mg (6 vrećica b)
Atazanavir (am): 1 hr after omeprazole Atazanavir AUC ↓30% (↓43% ↓14%) * Atazanavir Cmax ↓31% (↓42% ↓17%) * Atazanavir Cmin ↓31% (↓46% ↓12%) *
Atazanavir AUC ↓30% (↓43% ↓14%) * Atazanavir Cmax ↓31% (↓42% ↓17%) * Atazanavir Cmin ↓31% (↓46% ↓12%) *
Ritonavir 100 mg once daily (atazanavir 300 mg once daily)
Ritonavir 100 mg jedanput na dan (atazanavir 300 mg jedanput na dan)
REYATAZ once daily dose ritonavir once daily dosea
Doza ritonavira jedanput na dana
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.
U bolesnika koji primaju REYATAZ zabilježeni su Stevens-Johnsonov sindrom (SJS), multiformni eritem, toksične kožne erupcije i medikamentozni osip s eozinofilijom i sistemskim simptomima (DRESS).
Glecaprevir 300 mg / pibrentasvir 120 mg once daily (atazanavir 300 mg / ritonavir 100 mg once daily*)
Glecaprevir 300 mg / pibrentasvir 120 mg jedanput na dan (atazanavir 300 mg / ritonavir 100 mg jedanput na dan*)
Another 10 ml of formula is poured into the medicine cup or small container to rinse off remaining REYATAZ oral powder in the cup or container.
Cijela količina mješavine uvuče se u oralnu štrcaljku i primjeni s unutarnje strane desnog ili lijevog obraza dojenčeta Drugih 10 ml formule ulije se u medicinsku čašu ili mali spremnik kako bi se isprao ostatak REYATAZ oralnog praška u čaši ili spremniku.
Study 138 is an international randomised, open-label, multicenter, prospective trial of treatment naïve patients comparing REYATAZ/ritonavir (300 mg/100 mg once daily) to lopinavir/ritonavir (400 mg/100 mg twice daily), each in combination with fixed dose tenofovir disoproxil fumarate/emtricitabine (300 mg/200 mg tablets once daily).
U odraslih bolesnika koji prethodno nisu bili liječeni antiretrovirusnim lijekovima Ispitivanje 138 međunarodno je, randomizirano, multicentrično, prospektivno ispitivanje otvorenog tipa u bolesnika koji prethodno nisu bili liječeni u kojem se REYATAZ/ritonavir (300 mg/100 mg jedanput na dan) uspoređivao s lopinavirom/ritonavirom (400 mg/100 mg dvaput na dan), gdje su obje te kombinacije bile davane zajedno s fiksnom dozom tenofovirdizoproksilfumarata/emtricitabina (300 mg/200 mg tablete, jedanput na dan).
Efavirenz 600 mg once daily (atazanavir 400 mg once daily with ritonavir 200 mg once daily)
Efavirenz 600 mg jedanput na dan (atazanavir 400 mg jedanput na dan s ritonavirom 200 mg jedanput na dan)
Co-administration of voriconazole and REYATAZ/ritonavir is not recommended unless an assessment of the benefit/risk to the patient justifies the use of voriconazole (see section 4.4).
Ne preporučuje se istovremena primjena vorikonazola i lijeka REYATAZ/ritonavira osim kad procjena omjera koristi i rizika za bolesnika opravdava primjenu vorikonazola (vidjeti dio 4.4).
INFORMATION IN BRAILLE Outer carton: REYATAZ 150 mg
16. PODACI NA BRAILLEOVOM PISMU Kutija: REYATAZ 150 mg
HORMONAL CONTRACEPTIVES Ethinyloestradiol 25 μg + norgestimate (atazanavir 300 mg once daily with ritonavir 100 mg once daily)
Etinilestradiol 25 μg + norgestimat (atazanavir 300 mg jedanput na dan s ritonavirom 100 mg jedanput na dan)
Treatment-Naive REYATAZ Capsules/ritonavir (300 mg/100 mg once daily) n=16
Bolesnici koji prethodno nisu bili liječeni REYATAZ kapsulama i ritonavirom (300 mg/100 mg jedanput na dan) n=16
Co-administration of quetiapine with REYATAZ is contraindicated as REYATAZ may increase quetiapine-related toxicity.
Istodobna primjena kvetiapina i lijeka REYATAZ je kontraindicirana jer REYATAZ može povećati toksičnost povezanu s primjenom kvetiapina.
Co-administration with REYATAZ may result in increased concentrations of salmeterol and an increase in salmeterol-associated adverse events.
Istovremena primjena s lijekom REYATAZ može rezultirati povišenim koncentracijama salmeterola i pojačanim nuspojavama povezanima sa salmeterolom.
INFORMATION IN BRAILLE Outer carton: REYATAZ 200 mg
16. PODACI NA BRAILLEOVOM PISMU Kutija: REYATAZ 200 mg
3 x 60 hard capsules: EU/1/03/267/011
3 x 60 tvrdih kapsula: EU/1/03/267/011
a The mean baseline CD4 cell count was 337 cells/mm3 (range: 14 to 1,543 cells/mm3) and the mean baseline plasma HIV-1 RNA level was 4.4 log10 copies/ml (range: 2.6 to 5.88 log10 copies/ml).
Prosječni početni broj CD4 stanica iznosio je 337 stanica/mm3 (raspon: 14 do 1543 stanica/mm3) i prosječna početna razina HIV-1 RNK u plazmi bila je 4,4 log10 kopija/ml (raspon: 2,6 do 5,88 log10 kopija/ml).
Boceprevir 800 mg three times daily (atazanavir 300 mg/ritonavir 100 mg once daily)
Boceprevir 800 mg triput na dan (atazanavir 300 mg/ritonavir 100 mg jedanput na dan)