FrancophonIA/ELRC3.0 huggingface dataset:
English: • changes in skin colour including darkening of the skin in patches often starting on hands and soles of feet
Croatian: • promjene boje kože, uključujući mjestimično tamnjenje kože koje često započinje na šakama i tabanima
English: Cannabinoid test interaction
Croatian: Test interakcije kanabinoida
English: - if your doctor has told you that you have high or low levels of electrolytes such as potassium or magnesium in your blood.
Croatian: - ako Vam je liječnik rekao da imate visoke ili niske razine elektrolita u krvi kao što je kalij ili magnezij
English: Atripla should not be taken with any of these medicines.
Croatian: Atripla se ne smije uzimati zajedno s bilo kojim od tih lijekova.
English: However, as would be expected in this patient population, elevations in AST and ALT occurred more frequently than in the general HIV infected population.
Croatian: No kao što se u toj populaciji bolesnika moglo očekivati, porast vrijednosti AST i ALT bio je češći nego u općoj populaciji zaraženoj HIV-om.
English: Tell your doctor immediately if you feel depressed, have suicidal thoughts or have strange thoughts (see section 4, Possible side effects).
Croatian: Odmah se obratite liječniku osjetite li depresiju, ako razmišljate o samoubojstvu ili imate neobične misli (pogledajte dio 4, Moguće nuspojave).
English: -3.3 (-8.3% to 2.7%) patients with HIV-1 RNA < 200 copies/ml
Croatian: -3,3 (-8,3% do 2,7%) bolesnici s HIV-1 RNA < 200 kopija/ml
English: One tablet taken each day by mouth.
Croatian: Jedna tableta dnevno, primijenjena na usta.
English: Patients either changed to Atripla (N=203) or continued on their original antiretroviral treatment regimen (N=97).
Croatian: Bolesnici su ili prešli na Atriplu (N=203) ili su nastavili sa svojim prvotnim režimom antiretrovirusnog liječenja (N=97).
English: PVR (KM): Pure virologic response assessed using the Kaplan Meier (KM) method M: Missing
Croatian: PVR (KM): čisti virološki odgovor (engl. pure virologic response), ocijenjen primjenom Kaplan-Meierove (KM) metode N: nedostaje
English: Interrupting treatment with Atripla should also be considered in case of progressive decline of renal function when no other cause has been identified.
Croatian: Prekid liječenja Atriplom također treba razmotriti u slučaju progresivnog slabljenja funkcije bubrega ako se nije utvrdio niti jedan drugi uzrok.
English: If you have both HIV infection and hepatitis B, it is especially important not to stop your Atripla treatment without talking to your doctor first.
Croatian: Ako imate i HIV infekciju i hepatitis B, jako je važno da se ne prestanete liječiti Atriplom, a da prije toga niste razgovarali s liječnikom.
English: • increased levels of creatine kinase in the blood that may result in muscle pain and weakness
Croatian: • povećane razine kreatin kinaze u krvi koje mogu dovesti do bolova u mišićima i slabosti
English: Rare photoallergic dermatitis angioedema
Croatian: Rijetko fotoalergijski dermatitis angioedem
English: Efavirenz is highly bound (> 99%) to human plasma proteins, predominantly albumin.
Croatian: Efavirenz ima svojstvo snažnog vezivanja (> 99%) na proteine ljudske plazme, pretežno na albumin.
English: Effects on drug levels Mean percent change in AUC, Cmax, Cmin with 90% confidence intervals if available (mechanism)
Croatian: Učinci na razinu lijekova Srednja vrijednost postotka promjene AUC, Cmax, Cmin uz 90% intervale pouzdanosti ukoliko su dostupni (mehanizam)
English: What Atripla is and what it is used for What you need to know before you take Atripla How to take Atripla
Croatian: Što je Atripla i za što se koristi Što morate znati prije nego počnete uzimati Atriplu
English: As a general rule, it is recommended that HIV infected women do not breast-feed their infants in order to avoid transmission of HIV to the infant.
Croatian: Kao opće pravilo, preporučuje se da žene inficirane HIV-om ne doje svoju dojenčad kako bi se izbjegao prijenos virusa HIV-a na dojenče.
English: Similar results were found by other investigators, although the MPA plasma levels were more variable in the second study.
Croatian: Slični rezultati dobiveni su i drugi istraživači, iako su u drugom istraživanju postojale veće razlike u razinama MPA u plazmi.
English: Refer to section 2 “Atripla contains sodium”.
Croatian: Pogledajte dio 2, „Atripla sadržava natrij”.
English: Atripla is not usually taken with other medicines that can damage your kidneys (see Other medicines and Atripla).
Croatian: Atripla se obično ne uzima s drugim lijekovima koji Vam mogu oštetiti bubrege (pogledajte Drugi lijekovi i Atripla).
English: The potential for interactions with efavirenz and other azole antifungals, such as ketoconazole, has not been studied.
Croatian: Potencijal za interakcije s efavirenzom i drugim azolskim antimikoticima, poput ketokonazola, nije ispitan.
English: Biliary fibrosis has been observed in rats.
Croatian: U štakora je uočena bilijarna fibroza.
English: In the open-label extended phase of study GS-01-934, where patients received Atripla on an empty stomach, 3 additional cases of resistance were seen.
Croatian: U otvorenoj proširenoj fazi ispitivanja GS-01-934, u kojem su bolesnici uzimali Atriplu na prazan želudac, opažena su 3 dodatna slučaja rezistencije.
English: Insufficient safety data are available for children below 18 years of age.
Croatian: Nije dostupno dovoljno podataka o sigurnosti primjene kod djece mlađe od 18 godina.
English: - if you have a history of mental illness, including depression, or of substance or alcohol abuse.
Croatian: ako ste nekada imali psihičku bolest, uključujući depresiju, ili ovisnost o drogama ili alkoholu.
English: • a feeling of spinning or tilting (vertigo), whistling, ringing or other persistent noise in the ears
Croatian: • osjećaj vrtoglavice ili naginjanja (vertigo), zviždanje, zvonjava ili drugi stalan zvuk u ušima
English: Atripla may interact with other medicines, including herbal preparations such as Ginkgo biloba extracts.
Croatian: Atripla može imati interakcije s drugim lijekovima, uključujući biljne pripravke kao što je ekstrakt Ginkgo bilobe.
English: • liver failure, in some cases leading to death or liver transplant.
Croatian: • zatajenje jetre koje u nekim slučajevima može dovesti do smrti ili presađivanja jetre.
English: Both HIV and the ingredients of Atripla may pass through breast milk and cause serious harm to your baby.
Croatian: HIV i sastojci Atriple mogu se prenijeti majčinim mlijekom i ozbiljno naštetiti Vašem djetetu.
English: Most cases occurred in patients who already had liver disease, but there have been a few reports in patients without any existing liver disease
Croatian: U većini slučajeva dogodilo se kod bolesnika koji su imali postojeću bolest jetre, ali postoji i nekoliko slučajeva kod bolesnika bez postojeće bolesti jetre
English: If you have taken Atripla during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Croatian: Ako ste Atriplu uzimali tijekom trudnoće, postoji mogućnost da liječnik zatraži redovito provođenje pretraga krvi i drugih dijagnostičkih pretraga kako bi pratio razvoj vašega djeteta.
English: - anorexia
Croatian: - anoreksija
English: hypokalaemia2
Croatian: hipokalemija2
English: Contact your doctor or nearest emergency department for advice.
Croatian: Zatražite savjet od liječnika ili najbliže hitne medicinske službe.
English: - any signs of skin rash.
Croatian: bilo kakvi znakovi osipa na koži.
English: When you start or stop taking Atripla your doctor will closely monitor your plasma levels of the immunosuppressant and may need to adjust its dose.
Croatian: Kada započnete ili prestanete s uzimanjem Atriple, liječnik će Vam pomno nadzirati razine imunosupresiva u plazmi i možda će morati prilagoditi njihove doze.
English: Symptoms of your hepatitis may become worse after discontinuation of Atripla.
Croatian: Vaši simptomi hepatitisa možda će se pogoršati nakon prekida uzimanja Atriple.
English: Since use of two NNRTIs proved not beneficial in terms of efficacy and safety, co-administration of Atripla and another NNRTI is not recommended.
Croatian: Budući da se korištenje dvaju lijekova klase NNRTI nije pokazalo korisnim u smislu djelotvornosti i sigurnosti, ne preporučuje se istodobna primjena Atriple i nekog drugog lijeka klase NNRTI.
English: Efavirenz has also been shown to induce UGT1A1.
Croatian: Također se pokazalo da efavirenz inducira UGT1A1.
English: Alternatives to clarithromycin (e.g. azithromycin) may be considered.
Croatian: Može se razmotriti primjena alternativa klaritromicinu (npr. azitromicin).
English: Emtricitabine: Non-clinical data on emtricitabine reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.
Croatian: Neklinički podaci o emtricitabinu ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenosti, reproduktivne i razvojne toksičnosti.
English: Efavirenz has a relatively long terminal half-life of at least 52 hours after single doses (see also data from bioequivalence study described above) and 40 to 55 hours after multiple doses.
Croatian: Efavirenz ima relativno dug poluvijek od najmanje 52 sata nakon primjene pojedinačnih doza (pogledajte i podatke iz istraživanja bioekvivalencije opisane iznad) te 40 do 55 sati nakon primjene višekratnih doza.
English: If you are taking any of these medicines, your doctor may need to check the level of anticonvulsant medicine in your blood to ensure that it is not affected while taking Atripla.
Croatian: Uzimate li bilo koji od tih lijekova, Vaš liječnik mora provjeriti razinu antikonvulziva u Vašoj krvi da bi se osiguralo da se ona nije promijenila zbog uzimanja Atriple.
English: Other possible serious side effects
Croatian: Ostale moguće ozbiljne nuspojave
English: Taking these medicines with Atripla could cause serious or life-threatening side effects or stop these medicines from working properly.
Croatian: Uzimanje tih lijekova zajedno s Atriplom može uzrokovati ozbiljne ili po život opasne nuspojave ili onemogućiti pravilno djelovanje tih lijekova.
English: Following intravenous administration the volume of distribution of emtricitabine was approximately 1.4 l/kg.
Croatian: Nakon intravenske primjene volumen distribucije emtricitabina bio je približno 1,4 l/kg.
English: It is recommended that Atripla be taken on an empty stomach, preferably at bedtime.
Croatian: Preporučuje se uzimanje Atriple na prazan želudac, po mogućnosti prije spavanja.
English: Efavirenz exposure may be increased when given with medicinal products (for example ritonavir) or food (for example, grapefruit juice) which inhibit CYP3A4 or CYP2B6 activity.
Croatian: Izloženost efavirenzu može biti povećana kada se primjenjuje s lijekovima (na primjer, ritonavirom) ili hranom (na primjer, sokom od grejpa) koji inhibiraju aktivnost CYP3A4 ili CYP2B6.
English: In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Croatian: Pored oportunističkih infekcija, autoimuni poremećaji (stanje koje se javlja kada imunološki sustav napada zdravo tkivo Vašeg organizma) mogu se također dogoditi nakon početka uzimanja lijekova za liječenje infekcije HIV-om.
English: Sertraline:
Croatian: sertralin:
English: These problems tend to occur more often in those who have a history of mental illness.
Croatian: Ti se problemi češće javljaju u osoba koje već ranije imale mentalnu bolest.
English: Concomitant use of posaconazole and Atripla should be avoided unless the benefit to the patient outweighs the risk.
Croatian: Treba izbjegavati istodobnu primjenu posakonazola i Atriple, osim ako koristi za bolesnika premašuju rizik.
English: In addition, your doctor may consider giving you an additional dose of efavirenz to treat your HIV infection.
Croatian: Osim toga, liječnik će možda razmotriti i davanje dodatne doze efavirenza za liječenje Vaše infekcije HIV-om.
English: Uncommon: - dry mouth - incoherent speech - increased appetite - libido decreased - myalgia
Croatian: Manje često: - suha usta - inkoherentan govor - povećani apetit - smanjeni libido - mialgija
English: These immunosuppressants are not anticipated to impact exposure of efavirenz.
Croatian: Ne očekuje se da će ovi imunosupresivi utjecati na izloženost efavirenzu.
English: 1 Anaemia was common and skin discolouration (increased pigmentation) was very common when emtricitabine was administered to paediatric patients.
Croatian: 1 Anemija je bila česta, a promjena boje kože (povećana pigmentacija) vrlo česta kad se emtricitabin primjenjivao u pedijatrijskih bolesnika.
English: If you think you may have lactic acidosis, contact your doctor immediately.
Croatian: Mislite li da možda imate laktacidozu, odmah se obratite liječniku.
English: If bone abnormalities are suspected then appropriate consultation should be obtained.
Croatian: U slučaju sumnje na koštane abnormalnosti potrebno je odgovarajuće se konzultirati.
English: Some patients have had blood tests or symptoms indicating that their hepatitis has got worse after stopping emtricitabine or tenofovir disoproxil (two of the three components of Atripla).
Croatian: U nekih su bolesnika krvne pretrage ili simptomi ukazivali da se stanje hepatitisa pogoršalo nakon prestanka uzimanja emtricitabina ili tenofovirdizoproksila (dva od tri sastojka Atriple).
English: This medicine contains 23.6 mg sodium (main component of cooking/table salt) in each tablet.
Croatian: Ovaj lijek sadrži 23,6 mg natrija (glavni sastojak kuhinjske soli) u jednoj tableti.
English: Skin reactions
Croatian: Reakcije na koži
English: Because of interpatient variability in these parameters and concerns regarding development of resistance, HIV treatment guidelines should be consulted, also taking into consideration the reason for discontinuation.
Croatian: Zbog varijabilnosti ovih parametara među bolesnicima i mogućnosti razvoja rezistencije moraju se konzultirati smjernice za liječenje inficiranih HIV-om, a treba uzeti u obzir i razlog prekida terapije.
English: EU/1/07/430/001 30 film-coated tablets EU/1/07/430/002 90 (3 bottles of 30) film-coated tablets
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/430/001 30 filmom obloženih tableta EU/1/07/430/002 90 (3 boce po 30) filmom obloženih tableta
English: Cross-resistance profiles for efavirenz, nevirapine and delavirdine in vitro demonstrated that the K103N substitution confers loss of susceptibility to all three NNRTIs.
Croatian: Profili križne rezistencije za efavirenz, nevirapin i delavirdin in vitro pokazali su da supstitucija K103N dovodi do gubitka osjetljivosti na sva tri NNRTI lijeka.
English: If it is almost time (less than 12 hours) for your next dose anyway, do not take the missed dose.
Croatian: Ako je ionako skoro vrijeme da uzmete sljedeću dozu (preostalo je manje od 12 sati), nemojte uzeti propuštenu dozu.
English: However, in some patients, declines in creatinine clearance did not completely resolve despite tenofovir disoproxil discontinuation.
Croatian: Međutim, u nekih se bolesnika smanjenje klirensa kreatinina nije potpuno riješilo usprkos prekidu terapije tenofovirdizoproksila.
English: It is recommended that creatinine clearance is calculated in all patients prior to initiating therapy with Atripla and renal function (creatinine clearance and serum phosphate) is also monitored after two to four weeks of treatment, after three months of treatment and every three to six months thereafter in patients without renal risk factors.
Croatian: Preporučuje se izračunati klirens kreatinina u svih bolesnika prije nego se započne terapija Atriplom te pratiti funkciju bubrega (klirens kreatinina i razinu fosfata u serumu) nakon dva do četiri tjedna liječenja, nakon tri mjeseca liječenja i svakih tri do šest mjeseci nakon toga u bolesnika bez bubrežnih čimbenika rizika.
English: In such patients, interruption or discontinuation of treatment must be considered (see section 4.8).
Croatian: U tih bolesnika mora se razmotriti privremeni ili trajni prekid terapije (vidjeti dio 4.8).
English: One patient experienced involuntary muscle contractions.
Croatian: Kod jednog je bolesnika došlo do nekontrolirane kontrakcije mišića.
English: If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.
Croatian: Ako uočite bilo koje simptome infekcije ili druge simptome poput slabosti mišića, slabosti koja počinje u šakama i stopalima i pomiče se nagore prema trupu tijela, osjećaja lupanja srca, nevoljnog drhtanja ili hiperaktivnosti, odmah obavijestite svog liječnika kako biste dobili potrebno liječenje.
English: Efavirenz may also cause impaired concentration and/or somnolence.
Croatian: Efavirenz može uzrokovati i pad koncentracije i/ili somnolenciju.
English: In virologically suppressed patients, the clinical relevance of this reduction can be expected to be limited (see section 5.1).
Croatian: U bolesnika s virološkom supresijom može se očekivati ograničen klinički značaj ovog smanjenja (vidjeti dio 5.1).
English: The biotransformation of emtricitabine includes oxidation of the thiol moiety to form the 3'-sulphoxide diastereomers (approximately 9% of dose) and conjugation with glucuronic acid to form 2'-O-glucuronide (approximately 4% of dose).
Croatian: Biotransformacija emtricitabina uključuje oksidaciju tiolne skupine, pri čemu nastaju diastereomeri 3'-sulfoksida (približno 9% doze) i konjugaciju s glukoronskom kiselinom, pri čemu nastaje 2'-O-glukoronid (približno 4% doze).
English: The clinical outcome of this observed reduction of boceprevir trough concentrations has not been directly assessed.
Croatian: Klinički ishod ovog opaženog smanjenja najniže koncentracije boceprevira nije izravno procijenjen.
English: Since no dose recommendation can be made for itraconazole when used with Atripla, an alternative antifungal treatment should be considered.
Croatian: Budući da se ne može dati preporuka doze za itrakonazol kada se primjenjuje s Atriplom, treba razmotriti alternativnu antifungalnu terapiju.
English: In uninfected volunteers, multiple doses of 200 to 400 mg per day for 10 days resulted in a lower than predicted extent of accumulation (22 to 42% lower) and a shorter terminal half-life of 40 to 55 hours (single dose half-life 52 to 76 hours).
Croatian: U neinficiranih dobrovoljaca više doza od 200 do 400 mg po danu tijekom 10 dana rezultiralo je manjom akumulacijom lijeka od predviđenog (manja za 22 do 42%) i kraćim poluvijekom od 40 do 55 sati (poluvijek jedne doze 52 do 76 sati).
English: In particular, severe depression was more common in those with a history of depression.
Croatian: Posebno je uočena češća teška depresija u osoba s depresijom u anamnezi.
English: The silica gel desiccant is contained in a separate sachet and should not be swallowed.
Croatian: Sredstvo za sušenje od silikagela nalazi se u zasebnoj vrećici i ne smije se progutati.
English: Stayed on original treatment regimen (N=97) n/N (%)
Croatian: Ostali na prvotnom režimu liječenja (N=97) n/N (%)
English: Pharmacotherapeutic group: Antiviral for systemic use, antivirals for treatment of HIV infections, combinations, ATC code: J05AR06
Croatian: Farmakoterapijska skupina: Antivirusni lijek za sistemsku primjenu, antivirusni lijekovi za liječenje infekcije HIV-om, kombinacije, ATK oznaka: J05AR06
English: In other studies (prospective and cross-sectional), the most pronounced decreases in BMD were seen in patients treated with tenofovir disoproxil as part of a regimen containing a boosted protease inhibitor.
Croatian: U drugim ispitivanjima (prospektivnim i presječnim), najizraženija smanjenja BMD-a bila su opažena u bolesnika liječenih tenofovirdizoproksilom u sklopu režima koji je sadržavao pojačan inhibitor proteaze.
English: • forgetfulness, confusion, fitting (seizures), incoherent speech, tremor (shaking)
Croatian: • zaboravljivost, zbunjenost, grčenje (epileptični napadaji), nekoherentan govor, tremor (drhtanje)
English: Patients coinfected with HIV and HBV
Croatian: Bolesnici istodobno inficirani HIV-om i HBV-om
English: Carbamazepine plasma levels should be monitored periodically.
Croatian: Periodički treba kontrolirati razine karbamazepina u plazmi.
English: Pharmacokinetic studies have not been performed with efavirenz, emtricitabine or tenofovir in elderly patients (over 65 years of age).
Croatian: Nisu provedena farmakokinetička ispitivanja efavirenza, emtricitabina ili tenofovira u starijih bolesnika (starijih od 65 godina).
English: Since efavirenz is highly protein bound, dialysis is unlikely to remove significant quantities of it from blood.
Croatian: Budući da efavirenz ima svojstvo snažnog vezivanja na proteine, nije vjerojatno da se dijalizom mogu ukloniti značajne količine efavirenza iz krvi.
English: Because of the long half-life of efavirenz, use of adequate contraceptive measures for 12 weeks after discontinuation of Atripla is recommended.
Croatian: Zbog dugog poluvremena efavirenza preporučuje se korištenje odgovarajućih metoda kontracepcije 12 tjedana nakon prekida terapije Atriplom.
English: Reproductive toxicity studies showed increased foetal resorptions in rats.
Croatian: Ispitivanja reproduktivne toksičnosti pokazala su povećanu resorpciju zametaka u štakora.
English: In some cases, your doctor may need to adjust your dose or check your blood levels.
Croatian: U nekim slučajevima liječnik treba prilagoditi dozu lijeka ili provjeriti njegovu razinu u krvi.
English: • difficulty sleeping, abnormal dreams, difficulty concentrating, drowsiness
Croatian: • otežano spavanje, abnormalni snovi, poteškoće u koncentraciji, omamljenost
English: Both the K65R and M184V/I mutation remain fully susceptible to efavirenz.
Croatian: Mutacije K65R i M184V/I potpuno su osjetljive na efavirenz.
English: Data are available from 286 patients who switched to Atripla: 160 had previously received efavirenz, emtricitabine and tenofovir disoproxil, and 126 had previously received Combivir and efavirenz.
Croatian: Dostupni su podaci za 286 bolesnika koji su prebačeni na liječenje Atriplom: 160 njih prethodno je primalo efavirenz, emtricitabin i tenofovirdizoproksil, a 126 je prethodno primalo Combivir i efavirenz.
English: - if you have a heart disorder, such as abnormal electrical signal called prolongation of the QT interval.
Croatian: - ako imate srčani poremećaj, kao što je abnormalan električni signal koji se naziva produljenje QT intervala.
English: Tenofovir is primarily excreted by the kidneys by both filtration and an active tubular transport system with approximately 70 to 80% of the dose excreted unchanged in urine following intravenous administration.
Croatian: Tenofovir se prvenstveno izlučuje preko bubrega filtracijom i aktivnim tubularnim transportnim sustavom, pri čemu se oko 70-80% doze izlučuje u nepromijenjenom obliku u mokraći nakon intravenske primjene.
English: The use of Atripla in children and adolescents has not been studied.
Croatian: Primjena Atriple u djece i adolescenata nije ispitana.
English: When efavirenz is co-administered with a calcium channel blocker that is a substrate of the CYP3A4 enzyme, there is a potential for reduction in the plasma concentrations of the calcium channel blocker.
Croatian: Ako se efavirenz primjenjuje istodobno s blokatorom kalcijevih kanala koji je supstrat enzima CYP3A4, postoji mogućnost smanjenja plazmatske koncentracije blokatora kalcijevih kanala.
English: A positive relationship between efavirenz concentration and QTc prolongation was observed.
Croatian: Opažen je pozitivan odnos između koncentracije efavirenza i produljenja QTc-a.
English: Rosuvastatin is largely excreted unchanged via the faeces, therefore interaction with efavirenz is not expected.
Croatian: Rosuvastatin se uglavnom izlučuje putem stolice i zato se ne očekuje interakcija s efavirenzom.