FrancophonIA/ELRC3.0 huggingface dataset:
English: For children (6 to less than 18 years of age), your child's doctor will decide the right dose based on your child's weight.
Croatian: Za djecu (u dobi od 6 do manje od 18 godina), liječnik Vašeg djeteta odlučit će koja je doza ispravna na temelju tjelesne težine Vašeg djeteta.
English: If you miss a dose, take the missed dose as soon as possible with food and then take your next scheduled dose at its regular time.
Croatian: Ako propustite uzeti dozu, uzmite propuštenu dozu čim prije s hranom, a potom uzmite sljedeću dozu prema rasporedu u uobičajeno vrijeme.
English: Responders on LPV/RTV who completed treatment before Week 96 are excluded from Week 96 analysis.
Croatian: Bolesnici s odgovorom na LPV/RTV koji su završili liječenje prije 96. tjedna isključeni su iz analize podataka 96. tjedna.
English: Paediatric patients (less than 3 months of age)
Croatian: Pedijatrijski bolesnici (mlađi od 3 mjeseca)
English: • if you are allergic to atazanavir or any of the other ingredients of this medicine (listed in section 6)
Croatian: • ako ste alergični na atazanavir ili neki drugi sastojak ovog lijeka (naveden u dijelu 6)
English: Food effect
Croatian: Utjecaj hrane
English: Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Croatian: Tipično su takve reakcije opažene tijekom prvih nekoliko tjedana ili mjeseci nakon uvođenja terapije CART.
English: Ritonavir capsules, tablets or oral solution.
Croatian: Ritonavir kapsule, tablete ili oralna otopina.
English: 15 to less than 35 At least 35 * Ritonavir capsules, tablets or oral solution may be used.
Croatian: 15 do manje od 35 najmanje 35 * Mogu se uzimati ritonavir kapsule, tablete ili oralna otopina.
English: It is believed that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Croatian: Vjeruje se da ti simptomi nastaju zbog poboljšanog imunološkog odgovora tijela, koji tijelu omogućuje da se bori protiv infekcija koje su možda prisutne bez očitih simptoma.
English: Caution is warranted and therapeutic concentration monitoring is recommended when available.
Croatian: Traži se oprez i preporučuje se praćenje terapijske koncentracije, kad je dostupno.
English: For lipids, there is in some cases evidence for a treatment effect, while for weight gain there is no strong evidence relating this to any particular treatment.
Croatian: Za lipide, u nekim slučajevima postoji dokaz o učinku liječenja, dok za debljanje nema čvrstog dokaza povezanosti s bilo kojim posebnim liječenjem.
English: The best results in managing these events come from early diagnosis and immediate interruption of any suspect medicines.
Croatian: Najbolji rezultati u liječenju ovih promjena postižu se ranom dijagnozom i hitrim prekidom primjene svakog sumnjivog lijeka.
English: Mylan S.A.S., 117 Allee des Parcs, Saint-Priest, 69800, France
Croatian: Mylan S.A.S., 117 Allee des Parcs, Saint-Priest, 69800, Francuska
English: More frequent therapeutic concentration monitoring of these medicinal products is recommended until plasma levels have been stabilised.
Croatian: Preporučuje se češće praćenje terapijskih koncentracija ovih lijekova dok se ne stabiliziraju razine u plazmi.
English: Patients should be advised of the signs and symptoms and monitored closely for skin reactions.
Croatian: Bolesnike treba upozoriti na znakove i simptome i pažljivo ih nadzirati zbog kožnih reakcija.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
English: Safety
Croatian: Sigurnost
English: A causal relationship has been suggested, although the mechanism of action has not been elucidated.
Croatian: Smatra se da postoji uzročno-posljedična veza, iako mehanizam djelovanja nije razjašnjen.
English: It is normally used in combination with other anti-HIV medicines.
Croatian: Obično se uzima u kombinaciji s drugim lijekovima protiv HIV-a.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7.Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Withdrawal of ritonavir only under restrictive conditions
Croatian: Prekid primjene ritonavira samo pod restriktivnim uvjetima
English: There is a trend toward a higher clearance in younger children when normalised for body weight.
Croatian: Vidi se trend prema većem klirensu u mlađe djece, kad se normalizira prema tjelesnoj težini.
English: Clinical results
Croatian: Klinički rezultati
English: A dose reduction of buprenorphine may be considered
Croatian: Može se razmotriti sniženje doze buprenorfina.
English: Per protocol analysis: Excluding non-completers and patients with major protocol deviations.
Croatian: Analiza prema protokolu: isključujući one koji nisu dovršili ispitivanje i bolesnike s velikim odstupanjima od protokola.
English: Animal studies do not indicate reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na reproduktivnu toksičnost (vidjeti dio 5.3).
English: Buprenorphine, once daily, stable maintenance dose
Croatian: Buprenorfin, jedanput na dan, stabilna doza održavanja
English: - Keep this leaflet.
Croatian: • Sačuvajte ovu uputu.
English: If you have liver problems, including hepatitis B or C infection, you may experience a worsening of your liver problems.
Croatian: Ako imate problema s jetrom, uključujući infekciju hepatitisom B ili C, možete primijetiti pogoršanje Vaših problema s jetrom.
English: Frequency is defined using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000).
Croatian: Učestalost se definira na sljedeći način: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000).
English: • angioedema (severe swelling of the skin and other tissues most often the lips or the eyes)
Croatian: • angioedem (teško oticanje kože i drugih tkiva, najčešće usana i očiju)
English: A study of the pharmacokinetics of atazanavir was performed in 59 healthy male and female subjects (29 young, 30 elderly).
Croatian: Ispitivanje farmakokinetike atazanavira provedeno je u 59 zdravih muškaraca i žena (29 mladih, 30 starijih).
English: Dosage adjustment for midazolam should be considered, especially if more than a single dose of midazolam is administered.
Croatian: Potrebno je razmotriti prilagodbu doze midazolama, osobito ako se primjenjuje više od jednokratne doze midazolama.
English: In this instance, close clinical monitoring is warranted (see Interaction with other Medicinal Products below).
Croatian: U tom je slučaju obavezan strogi klinički nadzor (vidjeti Interakcije s drugim lijekovima, niže).
English: If your skin or the white part of your eyes turns yellow, talk to your doctor immediately.
Croatian: Ako Vaša koža ili bjeloočnica postanu žuti odmah se obratite liječniku.
English: Table 2: Interactions between atazanavir and other medicinal products
Croatian: Tablica 2: Interakcije između atazanavira i drugih lijekova
English: This way, you can be sure your medicine is fully effective and you reduce the risk of the virus developing resistance to the treatment.
Croatian: Na taj ćete način biti sigurni da je lijek potpuno učinkovit i smanjiti rizik od razvoja otpornosti virusa na liječenje.
English: Moreover, in case of withdrawal of glucocorticoids, progressive dose reduction may have to be performed over a longer period.
Croatian: Nadalje, u slučaju prestanka primjene glukokortikoida, može se provesti progresivno smanjenje doze tijekom duljeg razdoblja.
English: In more than half of the reported cases, treatment with protease inhibitors was continued or reintroduced if treatment had been discontinued.
Croatian: U više od polovice zabilježenih slučajeva nastavilo se s liječenjem inhibitorima proteaze ili se liječenje ponovno uvelo ako je bilo prekinuto.
English: There is a risk of loss of therapeutic effect and development of resistance (see section 4.3).
Croatian: Postoji rizik od gubitka terapijskog učinka i razvoja rezistencije (vidjeti dio 4.3).
English: • insomnia (difficulty sleeping)
Croatian: • nesanica (poteškoće sa spavanjem)
English: You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Croatian: HIV možete prenijeti čak i dok uzimate ovaj lijek, iako je tada rizik od prijenosa manji zbog učinkovite antiretrovirusne terapije.
English: In the majority of cases, jaundice was reported within a few days to a few months after the initiation of treatment (see section 4.4).
Croatian: U većine slučajeva, žutica je bila zabilježena unutar nekoliko dana do nekoliko mjeseci nakon početka liječenja (vidjeti dio 4.4).
English: • if you are taking an oral contraceptive ("the Pill") with Atazanavir Mylan to prevent pregnancy, be sure to take it exactly as instructed by your doctor and not miss any doses.
Croatian: • ako uzimate oralnu kontracepciju ("pilule") s lijekom Atazanavir Mylan za sprečavanje trudnoće, pazite da je uzimate točno prema uputama liječnika i da ne propustite niti jednu dozu
English: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Croatian: Svaki upalni simptom treba procijeniti i liječiti u slučaju potrebe.
English: Precautions to prevent transmission should be taken in accordance with national guidelines.
Croatian: Treba poduzeti mjere opreza za sprječavanje prijenosa bolesti u skladu s nacionalnim smjernicama.
English: Thirty-two percent of patients in the study had a viral strain with fewer than two NRTI substitutions.
Croatian: Trideset dva posto bolesnika u ovom ispitivanju imalo je virusni soj s manje od dvije supstitucije za rezistenciju na NRTI.
English: Immune reactivation syndrome
Croatian: Sindrom imunološke reaktivacije
English: It is recommended that the International Normalised Ratio (INR) be monitored carefully during treatment with atazanavir, especially when commencing therapy.
Croatian: Preporučuje se pažljivo pratiti međunarodni normalizirani omjer (INR) tijekom liječenja atazanavirom, osobito na početku terapije.
English: Administration of activated charcoal may also be used to aid removal of unabsorbed drug.
Croatian: Primjena aktivnog ugljena također se može koristiti kao pomoć u uklanjanju neapsorbiranog lijeka.
English: When treating HIV infection, it is not always easy to identify what side effects are caused by atazanavir, by the other medicines you are taking, or by the HIV infection itself.
Croatian: Kod liječenja HIV-infekcije, nije uvijek lako utvrditi koje su nuspojave izazvane atazanavirom, koje drugim lijekovima koje uzimate, a koje samom HIV-infekcijom.
English: Although not studied, similar results are expected with other proton pump inhibitors.
Croatian: Iako se to nije ispitivalo, slični se rezultati očekuju s drugim inhibitorima protonske pumpe.
English: It is one of a group called protease inhibitors.
Croatian: Pripada skupini lijekova koji se zovu inhibitori proteaze.
English: It is important to tell your doctor if you are taking fluticasone or budesonide (given by nose or inhaled to treat allergic symptoms or asthma).
Croatian: Važno je da obavijestite svog liječnika ako uzimate flutikazon ili budezonid (primjenjuju se kroz nos ili udisanjem za liječenje alergijskih simptoma ili astme).
English: To enhance bioavailability and minimise variability, atazanavir is to be taken with food.
Croatian: Da bi se pojačala bioraspoloživost i minimalizirala varijabilnost, atazanavir je potrebno uzimati s hranom.
English: While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.
Croatian: Iako je dokazano da učinkovita virusna supresija antiretrovirusnom terapijom značajno smanjuje rizik od prijenosa bolesti spolnim putem, ne može se isključiti rezidualni rizik.
English: During postpartum
Croatian: Tijekom postpartalnog razdoblja
English: A moderate amount of data in pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative toxicity of atazanavir.
Croatian: Umjerena količina podataka u trudnica (između 300-1000 ishoda trudnoća) ukazuje da atazanavir nema toksične malformacijske učinke.
English: ALPHA 1-ADRENORECEPTOR ANTAGONIST Alfuzosin
Croatian: ANTAGONIST ADRENORECEPTORA ALFA 1 Alfuzosin
English: It should be kept in mind that the twice weekly dosage of 150 mg may not provide an optimal exposure to rifabutin thus leading to a risk of rifamycin resistance and a treatment failure.
Croatian: Treba imati na umu da primjena doze od 150 mg dvaput tjedno možda neće osigurati optimalnu izloženost rifabutinu, što će dovesti do rizika od razvoja rezistencije na rifampicin i neuspješnog liječenja.
English: Potential for increased alfuzosin concentrations which can result in hypotension.
Croatian: Postoji mogućnost povišenih koncentracija alfuzosina koje mogu dovesti do hipotenzije.
English: Subsequent 9 month oral toxicity studies in dogs showed no drug-related electrocardiographic changes.
Croatian: Sljedeća ispitivanja oralne toksičnosti u pasa u trajanju od 9 mjeseci nisu pokazala elektrokardiografske promjene povezane s lijekom.
English: Consistent results were obtained with the last observation carried forward method of analysis (time-averaged difference of 0.11, 97.5% confidence interval [-0.15, 0.36]).
Croatian: Metodom analize u kojoj se koristi prijenos posljednjih zabilježenih rezultata (vremenski uprosječena razlika od 0,11, 97,5% interval pouzdanosti [-0,15, 0,36]) dobiveni su dosljedni rezultati.
English: This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves.
Croatian: To je djelomično povezano s poboljšanim zdravljem i stilom života, dok je u slučaju lipida u krvi katkad povezano i s lijekovima za liječenje HIV infekcije.
English: If you accidentally take more Atazanavir Mylan capsules than your doctor recommended, contact your HIV doctor at once or contact the nearest hospital for advice.
Croatian: Ako slučajno uzmete više Atazanavir Mylan kapsula nego što je preporučio Vaš liječnik, odmah se obratite liječniku ili potražite savjet u najbližoj bolnici.
English: Do not give this medicine to children younger than 3 months of age and weighing less than 5 kg.
Croatian: Nemojte davati ovaj lijek djeci mlađoj od 3 mjeseca i tjelesne težine manje od 5 kg.
English: Your doctor will evaluate how severe your liver disease is before deciding whether you can take Atazanavir Mylan
Croatian: Liječnik će procijeniti koliko je teška Vaša bolest jetre prije nego što odluči možete li uzimati Atazanavir Mylan
English: It is recommended that women infected with HIV do not breast-feed because the virus might be transmitted through the breast milk.
Croatian: Preporučuje se da žene zaražene HIV-om ne doje, zato što se virus može prenijeti majčinim mlijekom.
English: The 24 hour concentration following a high fat meal was increased by approximately 33% due to delayed absorption; the median Tmax increased from 2.0 to 5.0 hours.
Croatian: Dvadesetčetverosatna koncentracija nakon obroka bogatog mastima bila je povišena za približno 33% zbog odgođene apsorpcije; medijan Tmax povisio se s 2,0 na 5,0 sati.
English: Interactions between atazanavir and other medicinal products are listed in the table below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”).
Croatian: Interakcije između atazanavira i drugih lijekova navedene su u sljedećoj tablici (povišenje je označeno kao “↑”, sniženje kao “↓”, bez promjene kao “↔”).
English: • certain antibiotics (rifabutin, clarithromycin)
Croatian: • određene antibiotike (rifabutin, klaritromicin)
English: Close monitoring of patient's virologic response should be exercised.
Croatian: Treba pažljivo pratiti virološki odgovor bolesnika.
English: Similar concentrations of atazanavir increased by 13% the action potential duration (APD90) in rabbit Purkinje fibres study.
Croatian: Slične koncentracije atazanavira povećale su trajanje akcijskog potencijala za 13% (APD90) u ispitivanju na Purkinjeovim vlaknima kunića.
English: Dose reduction of atazanavir is not recommended because it may result in a loss of therapeutic effect and development of resistance.
Croatian: Ne preporučuje se snižavati dozu atazanavira zato što to može dovesti do gubitka terapijskog učinka i razvoja rezistencije.
English: Week 48: 1.7% [-3.8%, 7.1%] Week 96: 6.1% [0.3%, 12.0%]
Croatian: 48. tjedan: 1,7% [-3,8%, 7,1%] 96. tjedan: 6,1% [0,3%, 12,0%]
English: Pharmacotherapeutic group: Antivirals for systemic use, protease inhibitors, ATC code: J05AE08
Croatian: Farmakoterapijska skupina: antivirotici za sistemsku primjenu, inhibitori proteaze, ATK oznaka: J05AE08
English: The safety profile in this study was overall comparable to that seen in adults.
Croatian: Sigurnosni profil u ovim je ispitivanju općenito bio usporediv s onime u odraslih.
English: Following a possible decrease in atazanavir exposure during the second and third trimester, atazanavir exposures might increase during the first two months after delivery (see section 5.2).
Croatian: Nakon mogućeg smanjenja izloženosti atazanaviru tijekom drugog i trećeg tromjesečja, izloženost atazanaviru može biti povećana tijekom prva dva mjeseca nakon porođaja (vidjeti dio 5.2).
English: Your doctor will decide the right dose based on your child's weight.
Croatian: Liječnik će odrediti ispravnu dozu prema tjelesnoj težini Vašeg djeteta.
English: The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
Croatian: Trajanje kombinirane antiretrovirusne terapije, primjena kortikosteroida, konzumiranje alkohola, teška imunosupresija, povišen indeks tjelesne mase mogu, između ostalog, biti neki od mnogih čimbenika rizika za razvoj ove bolesti.
English: Store in the originalpackage in order to protect from moisture.
Croatian: Čuvati u originalnom pakiranju radi zaštite od vlage.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze-galaktoze ne smiju uzimati ovaj lijek.
English: Potential cardiac effects of this product in humans cannot be ruled out (see sections 4.4 and 4.8).
Croatian: Mogući učinci ovog lijeka na srce u ljudi ne mogu se isključiti (vidjeti dijelove 4.4 i 4.8).
English: • boceprevir (used to treat hepatitis C)
Croatian: • boceprevir (primjenjuje se za liječenje hepatitisa C)
English: Talk to your doctor or pharmacist before taking Atazanavir Mylan and make sure your doctor knows:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Atazanavir Mylan, i pobrinite se da liječnik zna:
English: • if you develop signs or symptoms of gall stones (pain at the right side of your stomach)
Croatian: • ako se u Vas razviju znakovi ili simptomi žučnih kamenaca (bol na desnoj strani trbuha)
English: These medicines control Human Immunodeficiency Virus (HIV) infection by stopping a protein that the HIV needs for its multiplication.
Croatian: Ti lijekovi kontroliraju infekciju virusom humane imunodeficijencije (HIV) tako što zaustavljaju rad proteina potrebnog HIV-u za umnažanje.
English: The effects of high fluticasone systemic exposure on ritonavir plasma levels are yet unknown.
Croatian: Učinci velike sistemske izloženosti flutikazonu na razinu ritonavira u plazmi još nisu poznati.
English: Metabolites are then excreted in the bile as either free or glucuronidated metabolites.
Croatian: Metaboliti se potom izlučuju u žuč u obliku slobodnih ili glukuroniziranih metabolita.
English: Serum cholesterol and glucose were minimally to mildly increased in rats but not in mice or dogs.
Croatian: Kolesterol i glukoza u serumu bili su minimalno do blago povišeni u štakora, ali ne u miševa ili pasa.
English: Difference estimate [95% CI]
Croatian: Približna razlika [95% CI]
English: No differences in frequency of bilirubin elevations were observed between these patients and those without viral hepatitis.
Croatian: Nisu bile opažene razlike u učestalosti povišenja bilirubina između tih bolesnika i onih bez virusnog hepatitisa.
English: NA = not applicable.
Croatian: NP = nije primjenjivo.
English: Table 5: Efficacy Outcomes in Study 138
Croatian: Tablica 5: Ishodi djelotvornosti u Ispitivanju 138
English: • other medicines to treat HIV infection (e.g. indinavir, nevirapine and efavirenz)
Croatian: • druge lijekove za liječenje HIV-infekcije (npr. indinavir, nevirapin i efavirenz)
English: Atazanavir (pm): all administered with food
Croatian: Atazanavir (pm): svi primijenjeni s hranom
English: A dose reduction of clarithromycin may result in subtherapeutic concentrations of 14-OH clarithromycin.
Croatian: Smanjenje doze klaritromicina može rezultirati supterapijskim koncentracijama 14-OH klaritromicina.
English: For dosing recommendations see section 4.2 and for pharmacokinetic data see section 5.2.
Croatian: Preporuke za doziranje vidjeti u dijelu 4.2, a farmakokinetičke podatke u dijelu 5.2.
English: Antacids and medicinal products containing buffers
Croatian: Antacidi i lijekovi koji sadrže pufere
English: Rash and associated syndromes
Croatian: Osip i povezani sindromi
English: Number of patients with paired genotypes classified as virological failures (HIV RNA ≥ 400 copies/ml).
Croatian: Broj bolesnika s uparenim genotipovima klasificiranih kao virološki neuspjeh (HIV RNK ≥ 400 kopija/ml).
English: It is important that you take Atazanavir Mylan with food (a meal or a substantial snack) as this helps the body absorb the medicine.
Croatian: Važno je da Atazanavir Mylan uzimate s hranom (uz obrok ili obilniji međuobrok) jer to pomaže tijelu da apsorbira lijek.
English: Tell your doctor immediately if you develop any of the following serious side effects:
Croatian: Odmah obavijestite liječnika ako se u Vas razvije jedna od sljedećih nuspojava:
English: Autoimmune disorders may occur many months after the start of treatment.
Croatian: Autoimune bolesti mogu se pojaviti i više mjeseci nakon početka liječenja.
English: The study assessed 40 infants who received antiretroviral prophylactic treatment (which did not include atazanavir) and were negative for HIV-1 DNA at the time of delivery and/or during the first 6 months postpartum.
Croatian: Ispitivanjem se procijenilo 40 dojenčadi koja su primala antiretrovirusno profilaktičko liječenje (koje nije uključivalo atazanavir) i bila negativna na HIV-1 DNK u vrijeme porođaja i/ili tijekom prvih šest mjeseci nakon rođenja.
English: Store below 25°C.
Croatian: Čuvati na temperaturi ispod 25 ºC.
English: • depression, anxiety, sleep disorder
Croatian: • depresija, tjeskoba, poremećaj spavanja
English: The pharmacokinetics of atazanavir were evaluated in healthy adult volunteers and in HIV-infected patients; significant differences were observed between the two groups.
Croatian: Farmakokinetika atazanavira ispitana je u zdravih dobrovoljaca i bolesnika zaraženih HIV-om; između te dvije skupine opažene su značajne razlike.
English: ACID REDUCING AGENTS H2-Receptor antagonists
Croatian: LIJEKOVI ZA SMANJENJE ŽELUČANE KISELINE Antagonisti H2 receptora