FrancophonIA/ELRC3.0 huggingface dataset:
English: Metabolic parameters Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4).
Croatian: Tjelesna težina i razine lipida i glukoze u krvi mogu biti povećane tijekom antiretrovirusne terapije (vidjeti dio 4.4.).
English: Consult the dosing table for the specific formulation (see relevant Summary of Product Characteristics).
Croatian: Provjerite tablicu doziranja za određeni oblik (vidjeti Sažetak opisa svojstava lijeka za druge oblike).
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).
Croatian: Iako se smatra da postoji više uzroka osteonekroze (uključujući primjenu kortikosteroida, konzumaciju alkohola, tešku imunosupresiju, povišen indeks tjelesne mase), slučajevi osteonekroze zabilježeni su osobito u bolesnika s uznapredovalom HIV-bolešću i/ili dugotrajnom izloženošću kombiniranoj antiretrovirusnoj terapiji.
English: Talk to your doctor immediately if you get dizzy, lightheaded or if you suddenly faint.
Croatian: Obratite se odmah liječniku osjećate omaglicu, ošamućenost ili se iznenada onesvijestite.
English: Includes patients with baseline resistance data.
Croatian: Uključuje bolesnike s početnim podacima o rezistenciji.
English: The pharmacokinetic data from HIV-infected pregnant women receiving atazanavir capsules with ritonavir are presented in Table 8.
Croatian: Farmakokinetički podaci prikupljeni u trudnica zaraženih HIV-om koje su uzimale atazanavir kapsule s ritonavirom prikazani su u tablici 8.
English: Data on withdrawal of ritonavir from atazanavir boosted regimen (see also section 4.4) Study 136 (INDUMA)
Croatian: Podaci o ukidanju ritonavira iz režima pojačanog atazanavirom (vidjeti dio 4.4) Ispitivanje 136 (INDUMA)
English: The withdrawal of ritonavir from the boosted regimen of atazanavir is not recommended, but may be considered in adults patients at the dose of 400 mg once daily with food only under the following combined restrictive conditions:
Croatian: Iako se izostavljanje ritonavira iz pojačanog režima liječenja atazanavirom ne preporučuje, ono se može razmotriti u odraslih bolesnika uz dozu od 400 mg jedanput na dan primijenjenu s hranom, ali samo ako su zadovoljeni svi sljedeći restriktivni uvjeti:
English: Pregnancy and postpartum
Croatian: Trudnoća i postpartalno razdoblje
English: Assessment of adverse reactions for atazanavir is based on safety data from clinical studies and postmarketing experience.
Croatian: Procjena nuspojava atazanavira temelji se na podacima o sigurnosti iz kliničkih ispitivanja i iskustvu nakon stavljanja lijeka u promet.
English: • that co-administration is not recommended with tenofovir, boceprevir, carbamazepine, phenytoin, phenobarbital, proton pump inhibitors, and buprenorphine.
Croatian: • Ne preporučuje se istovremena primjena s tenofovirom, boceprevirom, karbamazepinom, fenitoinom, fenobarbitalom, inhibitorima protonske pumpe i buprenorfinom.
English: • salmeterol (used to treat asthma)
Croatian: • salmeterol (primjenjuje se za liječenje astme)
English: Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Croatian: Bolesnici s kroničnim hepatitisom B ili C liječeni kombinacijom antiretrovirusnih lijekova imaju povećan rizik od teških i potencijalno smrtonosnih jetrenih nuspojava.
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 atazanavir oral powder of 80 weeks.
Croatian: U kliničkim ispitivanjima AI424-397 i AI424-451 u pedijatrijskih bolesnika u dobi od 3 mjeseca do manje od 11 godina, medijan trajanja liječenja atazanavir oralnim praškom iznosio je 80 tjedana.
English: - If you have any further questions, ask your doctor or pharmacist.
Croatian: • Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.
English: Based on data for other CYP3A4 inhibitors, plasma concentrations of midazolam are expected to be significantly higher when midazolam is given orally.
Croatian: Na temelju podataka za druge inhibitore enzima CYP3A4, očekuje se da će koncentracije midazolama u plazmi biti značajno više kad se midazolam daje peroralno.
English: The expiry date refers to the last day of that month.F
Croatian: Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.
English: Atazanavir given without ritonavir should not be used in pregnant patients given that it could result of suboptimal exposure of particular concern for the mother infection and vertical transmission.
Croatian: Atazanavir se bez ritonavira ne smije primjenjivati u trudnica jer to može dovesti do suboptimalne izloženosti lijeku, što je osobito problematično s obzirom na majčinu infekciju i vertikalni prijenos.
English: This co-administration might be considered on a case by case basis if deemed necessary, in patients with suppressed HIV viral loads and with HIV viral strain without any suspected resistance to the HIV regimen.
Croatian: Istovremena se primjena može razmatrati od slučaja do slučaja, ako se smatra potrebnom, u bolesnika sa suprimiranim virusnim opterećenjem HIV-om i sa sojem HIV-a za kojeg nema sumnje da je rezistentan na terapijski režim protiv HIV-a.
English: An increase in weight and in levels of blood lipids and glucose may occur during antiretroviral therapy.
Croatian: Povećanje tjelesne težine i razine lipida i glukoze u krvi mogu se pojaviti tijekom antiretrovirusne terapije.
English: Increased plasma concentrations of quetiapine may lead to coma (see section 4.3).
Croatian: Povećanje koncentracija kvetiapina u plazmi može dovesti do kome (vidjeti dio 4.3).
English: In in vivo studies in rats, atazanavir did not induce micronuclei in bone marrow, DNA damage in duodenum (comet assay), or unscheduled DNA repair in liver at plasma and tissue concentrations exceeding those that were clastogenic in vitro.
Croatian: U ispitivanjima in vivo u štakora, atazanavir nije izazvao nastanak mikronukleusa u koštanoj srži, oštećenje DNK u duodenumu (kometni test) ili neplanirani popravak DNK u jetri pri koncentracijama u plazmi i tkivu većima od onih koje su bile klastogene in vitro.
English: If an oral contraceptive is administered with atazanavir /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.
Croatian: Ako se oralna kontracepcija primjenjuje s atazanavirom s ritonavirom, preporučuje se da oralna kontracepcija sadrži najmanje 30 μg etinilestradiola i da se bolesnici istakne važnost redovitog uzimanja kontracepcije kod ovog kontracepcijskog režima.
English: Protease inhibitors: The co-administration of atazanavir/ritonavir and other protease inhibitors has not been studied but would be expected to increase exposure to other protease inhibitors.
Croatian: Inhibitori proteaze: Istovremena primjena atazanavira s ritonavirom i drugih inhibitora proteaze nije ispitana, ali pretpostavlja se da bi povećala izloženost drugim inhibitorima proteaze.
English: Human experience of acute overdose with atazanavir is limited.
Croatian: Iskustvo s akutnim predoziranjem atazanavirom u ljudi je ograničeno.
English: Once opened: Use within 90 days Date opened:
Croatian: Nakon otvaranja: iskoristiti u roku od 90 dana Datum otvaranja:
English: Although not studied, there is a potential for an increase in pravastatin or fluvastatin exposure when co-administered with protease inhibitors.
Croatian: Iako interakcija nije ispitivana, postoji mogućnost povećane izloženosti pravastatinu ili fluvastatinu kada se primjenjuju zajedno s inhibitorima proteaze.
English: 2D barcode carrying the unique identifier included
Croatian: Sadrži 2D barkod s jedinstvenim identifikatorom
English: During this time, postpartum patients should follow the same dose recommendation as for non-pregnant patients, including those for co-administration of medicinal products known to affect atazanavir exposure (see section 4.5).
Croatian: Tijekom ovog vremena, bolesnice u postpartalnom razdoblju trebaju nastaviti s istom dozom kakva se preporučuje bolesnicama koje nisu trudne, uključujući one koje istovremeno primaju lijekove za koje se zna da utječu na izloženost atazanaviru (vidjeti dio 4.5).
English: (See section 4.4, Withdrawal of ritonavir only under restrictive conditions)
Croatian: (Vidjeti odlomak "Prekid primjene ritonavira samo pod restriktivnim uvjetima" u dijelu 4.4)
English: In the pre- and postnatal development assessment in rats, atazanavir produced a transient reduction in body weight in the offspring at a maternally toxic dose.
Croatian: Procjena prednatalnog i postnatalnog razvoja u štakora pokazala je da je atazanavir izazvao prolazno smanjenje tjelesne težine u potomstva pri maternalno toksičnim dozama.
English: No dosage adjustment is needed.
Croatian: Nije potrebna prilagodba doze.
English: b See description of selected adverse reactions for more details.
Croatian: Vidjeti opis odabranih nuspojava, za dodatne informacije.
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 single-cell necrosis.
Croatian: U ispitivanjima toksičnosti ponovljenih doza provedenih u miševa, štakora i pasa, nalazi povezani s atazanavirom općenito su bili ograničeni na jetru i uključivali su općenito minimalna do blaga povišenja serumskog bilirubina i jetrenih enzima, hepatocelularnu vakuolizaciju i hipertrofiju te, samo u ženki miša, nekrozu pojedinačnih jetrenih stanica.
English: At high doses that lead to high drug exposures, jaundice due to indirect (unconjugated) hyperbilirubinaemia (without associated liver function test changes) or PR interval prolongations may be observed (see sections 4.4 and 4.8).
Croatian: Pri visokim dozama koje dovode do visoke izloženosti lijeku može se vidjeti žutica zbog indirektne hiperbilirubinemije (nekonjugirani bilirubin) (bez s time povezanih promjena testova jetrene funkcije) ili produljenje PR intervala (vidjeti dijelove 4.4 i 4.8).
English: Overall in this study, 182 paediatric patients (81 antiretroviral-naive and 101 antiretroviral-experienced) received once daily atazanavir (capsule or powder formulation), with or without ritonavir, in combination with two NRTIs.
Croatian: U ovom su ispitivanju ukupno 182 pedijatrijska bolesnika (81 koji prethodno nisu bili liječeni i 101 prethodno liječeni antiretrovirusnim lijekovima) primala atazanavir (kapsule ili u prašku) jedanput na dan, s ritonavirom ili bez njega, u kombinaciji s dva NRTI-ja.
English: CD4 count <50 cells/mm
Croatian: Broj CD4 stanica <50 stanica/mm
English: Rare (may affect up to 1 in 1,000 people):
Croatian: Rijetko (mogu se javiti u manje od 1 na 1000 osoba):
English: Atazanavir was negative in an Ames reverse-mutation assay but did induce chromosomal aberrations in vitro in both the absence and presence of metabolic activation.
Croatian: Atazanavir je pokazao negativan rezultat na Amesovom testu reverznih mutacija, ali nije izazvao kromosomske aberacije in vitro u prisutnosti ili odsutnosti metaboličke aktivacije.
English: Atazanavir should not be used in combination with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index.
Croatian: Atazanavir se ne smije primjenjivati u kombinaciji s lijekovima koji su supstrati enzima CYP3A4 i imaju uzak terapijski indeks.
English: Ritonavir Dose* once daily (mg)
Croatian: Doza ritonavira* jedanput na dan (mg)
English: In clinical trial AI424-182 atazanavir/ritonavir (300/100 mg or 400/100 mg) in combination with zidovudine/lamivudine was administered to 41 pregnant women during the second or third trimester.
Croatian: U kliničkom je ispitivanju AI424-182 atazanavir/ritonavir (300/100 mg ili 400/100 mg) u kombinaciji sa zidovudinom/lamivudinom bio primijenjen u 41 trudnice tijekom drugog ili trećeg tromjesečja.
English: The M184V substitution in reverse transcriptase, which confers resistance to lamivudine and emtricitabine, was detected in 2 subjects in the unboosted atazanavir and 1 subject in the atazanavir + ritonavir group.
Croatian: Supstitucija M184V u reverznoj transkriptazi, koja uzrokuje rezistenciju na lamivudin i emtricitabin, otkrivena je u 2 ispitanika liječena nepojačanim atazanavirom i 1 ispitanika koji je primao atazanavir + ritonavir.
English: Atazanavir increased opacity of bovine corneas in an in vitro ocular irritation study, indicating it may be an ocular irritant upon direct contact with the eye.
Croatian: Atazanavir je povećao neprozirnost goveđih rožnica u jednom in vitro ispitivanju nadraženosti oka, što ukazuje ne to da može biti iritans za oči u slučaju izravnog kontakta s okom.
English: ANTIBIOTICS Clarithromycin 500 mg twice daily
Croatian: ANTIBIOTICI Klaritromicin 500 mg dvaput na dan
English: Of the 60 isolates from patients treated with either atazanavir or atazanavir + ritonavir, 18 (30%) displayed the I50L phenotype previously described in naive patients.
Croatian: Od 60 izolata iz bolesnika liječenih atazanavirom ili atazanavirom s ritonavirom, 18 (30%) je imalo fenotip I50L, prethodno opisan u bolesnika koji prije nisu bili liječeni.
English: Indinavir is also associated with indirect (unconjugated) hyperbilirubinaemia due to inhibition of UGT.
Croatian: Indinavir je također povezan s indirektnom (nekonjugirani bilirubin) hiperbilirubinemijom zbog inhibicije UGT.
English: In clinical studies, atazanavir (with or without ritonavir) has been shown to induce dyslipidaemia to a lesser extent than comparators.
Croatian: U kliničkim se ispitivanjima pokazalo da atazanavir (s ili bez ritonavira) izaziva dislipidemiju u manjem opsegu nego drugi slični lijekovi.
English: What Atazanavir Mylan is and what it is used for
Croatian: Što je Atazanavir Mylan i za što se koristi
English: • warfarin (anticoagulant, used to reduce the blood clots)
Croatian: • varfarin (antikoagulans, primjenjuje se za smanjenje zgrušavanja krvi)
English: There are no pharmacokinetic data available for atazanavir with ritonavir in patients with renal insufficiency.
Croatian: Nema dostupnih farmakokinetičkih podataka za atazanavir s ritonavirom u bolesnika s insuficijencijom bubrega.
English: • lurasidone (used to treat schizophrenia).
Croatian: • lurasidon (primjenjuje se za liječenje shizofrenije)
English: Combination of rifampicin (see section 4.5).
Croatian: Kombinacija s rifampicinom (vidjeti dio 4.5).
English: uncommon: hypertension
Croatian: manje često: hipertenzija
English: • myopathy (aching muscles, muscle tenderness of weakness, not caused by exercise)
Croatian: • miopatija (bolni mišići, osjetljivost na dodir i slabost mišića, što nije prouzročeno vježbanjem)
English: • the need to consider that - co-administration of voriconazole and atazanavir without ritonavir may affect atazanavir concentrations - co-administration of fluticasone and atazanavir without ritonavir may increase fluticasone concentrations relative to fluticasone given alone - if an oral contraceptive is administered with atazanavir without ritonavir, it is recommended that the oral contraceptive contain no more than 30 µg of ethinyloestradiol - no dose adjustment of lamotrigine is required
Croatian: • Treba imati na umu da: - istovremena primjena vorikonazola i atazanavira bez ritonavira može utjecati na koncentracije atazanavira; - istovremena primjena flutikazona i atazanavira bez ritonavira može povisiti koncentracije flutikazona u odnosu na koncentracije flutikazona primijenjenog samostalno, - ako se istovremeno s atazanavirom bez ritonavira primjenjuje oralni kontraceptiv, preporučuje se da oralni kontraceptiv ne sadrži više od 30 µg etinilestradiola, - nije potrebno prilagođavati dozu lamotrigina.
English: Other marked clinical laboratory abnormalities (Grade 3 or 4) reported in ≥ 2% of patients receiving regimens containing atazanavir 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%).
Croatian: Drugi značajni kliničko-laboratorijski poremećaji (3. ili 4. stupnja) zabilježeni u ≥ 2% bolesnika koji su primali terapijske protokole s atazanavirom i jednim ili više NRTI-jeva uključivali su: povišenu kreatin kinazu (7%), povišen omjer alanin aminotransferaze i serumske glutamin-piruvatne transaminaze (ALT/SGPT) (5%), nizak broj neutrofila (5%), povišen omjer aspartat aminotransferaze i serumske glutamat-oksaloctene transaminaze (AST/SGOT) (3%) i povišenu lipazu (3%).
English: Rifampicin is a strong CYP3A4 inducer and has been shown to cause a 72% decrease in atazanavir AUC which can result in virological failure and resistance development.
Croatian: Rifampicin je jaki induktor enzima CYP3A4 i pokazalo se da smanjuje AUC atazanavira, što može rezultirati virološkim neuspjehom i razvojem rezistencije.
English: % (responder/evaluable d)
Croatian: % (bolesnici s odgovorom/bolesnici koje se moglo procijeniti d)
English: ≥100,000 copies/ml
Croatian: ≥100 000 kopija/ml
English: Subjects with at least one functional CYP2C19 allele.
Croatian: Osobe s najmanje jednim funkcionalnim CYP2C19 alelom.
English: Systemic exposure to atazanavir at doses that resulted in maternal toxicity was at least equal to or slightly greater than that observed in humans given 400 mg once daily.
Croatian: Sistemska izloženost atazanaviru u dozama koje su rezultirale maternalnom toksičnošću bila je barem jednaka ili nešto veća od one opažene u ljudi koji su dobivali 400 mg jedanput na dan.
English: • buprenorphine (used to treat opioid addiction and pain).
Croatian: • buprenorfin (primijenjuje se za liječenje ovisnosti o opijatima i boli)
English: In long-term carcinogenicity studies of atazanavir in mice and rats, an increased incidence of benign hepatic adenomas was seen in female mice only.
Croatian: U dugotrajnim ispitivanjima kancerogenosti atazanavira u miševa i štakora opažena je povećana učestalost benignih adenoma jetre, ali samo u ženki miša.
English: ** When compared to rifabutin 150 mg once daily alone.
Croatian: ** Kad se usporedio samo s rifabutinom 150 mg jedanput na dan.
English: A safe and effective dose in combination with atazanavir has not been established for sildenafil when used to treat pulmonary arterial hypertension.
Croatian: Nije ustanovljena sigurna i djelotvorna doza sidenafila u kombinaciji s atazanavirom kad se sildenafil primjenjuje za liječenje plućne arterijske hipertenzije.
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Croatian: Ako se u tih bolesnika dokaže pogoršanje bolesti jetre, mora se razmotriti privremeni ili trajni prekid liječenja.
English: In a multiple-dose study in HIV-infected 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.
Croatian: U ispitivanju višestrukih doza u bolesnika zaraženih HIVom koji su primali doze od 400 mg atazanavira jedanput na dan uz lagani obrok tijekom 12 tjedana, atazanavir je otkriven u cerebrospinalnom likvoru i sjemenu.
English: • Atazanavir may affect how well your kidneys work.
Croatian: • Atazanavir može utjecati na to kako dobro rade vaši bubrezi.
English: 50 to <100 cells/mm
Croatian: 50 do <100 stanica /mm
English: While the concentration of ethinyloestradiol was increased with atazanavir given alone, due to both UGT and CYP3A4 inhibition by atazanavir, the net effect of atazanavir/ritonavir is a decrease in ethinyloestradiol levels because of the inducing effect of ritonavir.
Croatian: Iako je koncentracija etinilestradiola bila povišena kad se atazanavir davao sam, zbog toga što atazanavir inhibira enzime UGT i CYP3A4, neto učinak atazanavira/ritonavira je sniženje razina etinilestradiola zbog inducirajućeg učinka ritonavira.
English: • Liver problems may uncommonly happen.
Croatian: • Manje često se mogu pojavit problemi s jetrom.
English: ANTIMYCOBACTERIAL
Croatian: ANTIMIKOBAKTERIJSKI
English: There are other medicines that may not mix with Atazanavir Mylan.
Croatian: Postoje i drugi lijekovi koji se ne smiju miješati s lijekom Atazanavir Mylan.
English: In paediatric patients with pre-existing conduction problems (second degree or higher atrioventricular or complex bundle-branch block), Atazanavir Mylan should be used with caution and only if the benefits exceed the risk.
Croatian: U pedijatrijskih bolesnika s već prisutnim poremećajem provođenja (atrioventrikularni blok drugog ili višeg stupnja ili kompletni blok grane) Atazanavir Mylan treba primjenjivati s oprezom i samo ako je korist veća od rizika.
English: Fifteen of 120 (13%) patients in the atazanavir + ritonavir treatment arm and 17 of 123 (14%) patients in the lopinavir + ritonavir arm had four or more of the PI substitutions L10, M46, I54, V82, I84, and L90.
Croatian: Petnaest od 120 (13%) bolesnika u terapijskoj skupini koja je primala atazanavir + ritonavir i 17 od 123 (14%) bolesnika u skupini koja je primala lopinavir + ritonavir imalo je četiri ili više supstitucija za rezistenciju na inhibitore proteaze: L10, M46, I54, V82, I84 i L90.
English: 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.
Croatian: U antiretrovirusnom liječenju prethodno liječenih bolesnika u Ispitivanjima 009, 043 i 045, u 100 izolata iz bolesnika u kojih je terapija atazanavirom, atazanavirom s ritonavirom ili atazanavirom sa sakvinavirom bila virološki neuspješna utvrđeno je da se razvila rezistencija na atazanavir.
English: Some medicines may interact with ritonavir, a medicine that is taken with Atazanavir Mylan.
Croatian: Neki lijekovi mogu ući u interakciju s ritonavirom, koji se uzima zajedno s lijekom Atazanavir Mylan.
English: Atazanavir Mylan is not a cure for HIV infection.
Croatian: Atazanavir Mylan neće izliječiti HIV-infekciju.
English: Medicinal products by therapeutic area
Croatian: Lijekovi prema terapijskom području
English: (ritonavir 100 mg capsules twice daily)
Croatian: (ritonavir 100 mg kapsule dvaput na dan)
English: There were no reported cases of kernicterus in neonates.
Croatian: Nije bilo zabilježenih slučajeva kernikterusa u novorođenčadi.
English: Reduced plasma concentrations of atazanavir may be the consequence of increased gastric pH if antacids, including buffered medicinal products, are administered with atazanavir.
Croatian: Snižene koncentracije atazanavira u plazmi mogu biti posljedica povišenog želučanog pH ako se antacidi, uključujući puferirane lijekove, primjenjuju s atazanavirom.
English: INHALED BETA AGONISTS Salmeterol
Croatian: INHALACIJSKI BETA AGONISTI
English: For bottles: Once opened, use within 90 days.
Croatian: Za boce: Nakon otvaranja iskoristiti u roku od 90 dana.
English: Administration of atazanavir 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.
Croatian: Primjena atazanavira s ritonavirom uz lagani obrok ili obrok bogat mastima smanjila je koeficijent varijacije AUC i Cmax za približno 25% u usporedbi s onima natašte.