FrancophonIA/ELRC3.0 huggingface dataset:
English: If needed, consult your pharmacist for help with this procedure.
Croatian: Ako je potrebno, zatražite savjet od ljekarnika u vezi s ovim postupkom.
English: Zerit may improve your condition, but it is not a cure for your HIV infection.
Croatian: Vaše stanje, ali on neće izliječiti Vašu HIV infekciju.
English: When treating HIV infection it is not always possible to differentiate between unwanted effects caused by Zerit or those caused by any other medicines you may be taking at the same time, or by the complications of the infection.
Croatian: Kada se liječi infekcija HIV-om, nije uvijek moguće razlikovati neželjene učinke uzrokovane lijekom Zerit od onih koje su uzrokovali drugi lijekovi koje ste uzimali istovremeno, ili koji su uzrokovani komplikacijama infekcije.
English: Only the data from the marketed formulation are presented.
Croatian: Prikazani su podaci samo onih oblika koji su na tržištu.
English: Do not take Zerit
Croatian: Nemojte uzimati Zerit
English: If you have problems swallowing capsules you should ask your doctor about the possibility of changing to the solution form of this medicine or you could carefully open the capsule and mix its contents with some food.
Croatian: Ako imate problema s gutanjem kapsula zatražite Vašeg liječnika da vam omogući zamjenu za oblik lijeka u obliku otopine ili možete pažljivo otvoriti kapsulu i pomiješati je s nešto hrane.
English: Some patients taking Zerit may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Croatian: Neki bolesnici koji uzimaju Zerit mogu razviti bolest kostiju zvanu osteonekroza (odumiranje koštanog tkiva uzrokovano gubitkom opskrbe krvlju kostiju).
English: Whether such neurological disorders are transient or permanent is currently unknown.
Croatian: Trenutno nije poznato da li su neurološki poremećaji prolazni ili trajni.
English: When such development is found, treatment with Zerit should not be continued (see section 4.4).
Croatian: Kad se takav razvoj otkrije, ne smije se nastaviti liječenje lijekom Zerit (vidjeti dio 4.4).
English: These findings should be considered for any child exposed in utero to nucleos(t)ide analogues, that present with severe clinical findings of unknown etiology, particularly neurologic findings.
Croatian: Ove nalaze potrebno je uzeti u obzir za bilo koje dijete izloženo in utero analozima nukleoz(t)ida kod kojeg je prisutan težak klinički nalaz nepoznate etiologije, posebice neurološki nalazi.
English: This loss of body fat has been shown to be not fully reversible after discontinuation of stavudine.
Croatian: Taj gubitak masnog tkiva nije potpuno reverzibilan nakon prestanka primjene stavudina.
English: Patients were primarily males (70%) and non-white (58%) with a median age of 33 years (range 18 to 68 years).
Croatian: Bolesnici su bili većinom muškarci (70%) i ne-bijelci (58%) sa medijanom dobi od 33 godine (raspon od 18 do 68 godina).
English: Adult patients that have problems swallowing capsules should ask their doctor about the possibility of changing to the powder formulation of this medicine.
Croatian: Odrasli bolesnici koji imaju problem s gutanjem kapsula trebali bi zatražiti svog liječnika da im omogući zamjenu za praškasti oblik ovog lijeka.
English: Studies in lactating rats showed that stavudine is excreted in breast milk.
Croatian: Ispitivanja na štakorima u laktaciji su pokazala da se stavudin izlučuje u mlijeku.
English: Patients receiving Zerit should be frequently examined and questioned for signs of lipoatrophy.
Croatian: Bolesnike koji primaju Zerit potrebno je često pregledavati i pitati ih o znakovima lipoatrofije.
English: The evolution of motor weakness may mimic the clinical presentation of Guillain-Barré syndrome (including respiratory failure).
Croatian: Razvoj motoričke slabosti može imitirati kliničku sliku GuillainBarréovog sindroma (uključujući respiratorno zatajenje).
English: The mean terminal elimination half-life of stavudine is 1.3 to 2.3 hours following single or multiple doses, and is independent of dose.
Croatian: Prosječno terminalno poluvrijeme eliminacije stavudina je 1,3 do 2,3 sata nakon jedne ili više doza i ne ovisi o veličini doze.
English: Warnings and precautions Talk to your doctor before taking Zerit.
Croatian: Upozorenja i mjere oprezaObratite se svom liječniku prije nego uzmete Zerit.
English: Zerit + lamivudine + efavirenz n=391
Croatian: Zerit + lamivudin + efavirenz n= 391
English: The use of stavudine in adolescents, children and infants is supported by pharmacokinetic and safety data in paediatric patients (see also sections 4.8 and 5.2).
Croatian: Upotrebu stavudina u adolescenata, djece i dojenčadi podupiru podaci o farmakokinetici i sigurnosti primjene u pedijatrijskih bolesnika. (vidjeti dijelove 4.8 i 5.2).
English: Keep the bottle tightly closed in order to protect from excessive moisture.
Croatian: Bocu čuvati čvrsto zatvorenu radi zaštite od prekomjerne vlage.
English: Patients co-infected with hepatitis C and treated with alpha interferon and ribavirin may constitute a special risk.
Croatian: Bolesnici koinficirani s hepatitisom C i liječeni alfa-interferonom i ribavirinom mogu biti pod posebnim rizikom.
English: For patients starting therapy with Zerit, the duration should be limited to the shortest time possible followed by a switch to an alternative appropriate therapy whenever possible.
Croatian: U bolesnika koji počinju terapiju lijekom Zerit, trajanje liječenja bi trebalo ograničiti na najkraće moguće vrijeme nakon čega liječenje treba zamjeniti alternativnom prikladnom terapijom kad god je to moguće.
English: Two to three hours post-dose, CSF/plasma ratios of stavudine ranged from 16% to 125% (mean of 59%±35%).
Croatian: Dva do tri sata nakon primjene doze, omjer stavudina CSF/plazma kretao se u rasponu od 16% do 125% (srednji od 59%±35%).
English: The HIV status for the newborns and infants ≤ 3 months of age was negative, for older infants it tended to be positive.
Croatian: HIV-status novorođenčadi i dojenčadi ≤ 3 mjeseca starosti bio je negativan, dok je u starije dojenčadi češće bio pozitivan.
English: If this is not possible, the capsules may also be taken with a light meal.
Croatian: Ako to nije moguće, tada se kapsule mogu uzeti s laganim obrokom.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake kategorije nuspojave su navedene prema sve manjoj ozbiljnosti.
English: After reconstitution, store the prepared oral solution in a refrigerator (2°C - 8°C) for 30 days.
Croatian: Nakon rekonstitucije za primjenu, pripremljenu oralnu otopinu čuvati u hladnjaku (2°C - 8°C) do 30 dana.
English: Complications of chronic overdosage could include peripheral neuropathy and hepatic dysfunction.
Croatian: Komplikacije kroničnog predoziranja mogle bi uključivati perifernu neuropatiju i poremećaj funkcije jetre.
English: If you have taken too much of the solution, or if someone accidentally swallows some, there is no immediate danger.
Croatian: Ako uzmete previše otopine ili ako je netko slučajno progutao nekoliko, nema neposredne opasnosti.
English: Motor weakness has been reported rarely in patients receiving combination antiretroviral therapy including Zerit.
Croatian: Motorička slabost rijetko je zabilježena u bolesnika na kombiniranoj antiretrovirusnoj terapiji koja uključuje Zerit.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis carinii pneumonia.
Croatian: Važniji primjeri su citomegalovirusni retinitis, generalizirane i/ili fokalne mikobakterijske infekcije i pneumonija uzrokovana Pneumocystis carinii.
English: What you need to know before you take Zerit 3.
Croatian: Što morate znati prije nego počnete uzimati Zerit 3.
English: To reconsistute Zerit, add 202 ml of water to the original bottle (when the patient makes up the solution, they should be instructed to fill to the top edge of the bottle label, indicated by the arrow marks).
Croatian: Da bi se Zerit rekonstituirao, dodajte 202 ml vode u originalnu bocu (kad bolesnik radi otopinu,trebao bi biti upućen da nadopuni do gornjeg ruba naljepnice na boci, označenog znakom strelice).
English: Zerit + lamivudine + efavirenz n=76
Croatian: Zerit + lamivudin + efavirenz n= 76
English: Endocrine disorders:
Croatian: Endokrini poremećaji:
English: Since urinary excretion is also a major route of elimination of stavudine in paediatric patients, the clearance of stavudine may be altered in paediatric patients with renal impairment.
Croatian: Budući da je izlučivanje urinom glavni put eliminacije stavudina u pedijatrijskih bolesnika, klirens stavudina može biti promijenjen u pedijatrijskih bolesnika s oštećenjem bubrega.
English: Elderly: Zerit has not been specifically investigated in patients over the age of 65.
Croatian: Starije osobe: Zerit se nije posebno ispitivao u bolesnika starijih od 65 godina.
English: The data available on stavudine excretion into human breast milk are insufficient to assess the risk to the infant.
Croatian: Podaci o izlučivanju stavudina u majčino mlijeko nisu dostatni za utvrđivanje rizika za dojenče.
English: The incidence and severity of lipoatrophy are related to cumulative exposure, and is often not reversible when stavudine treatment is stopped.
Croatian: Incidencija i težina lipoatrofije povezana je s ukupnom izloženošću i često nije reverzibilna kada se liječenje stavudinom prekine.
English: Relevant grade 3-4 laboratory abnormalities in the 91 stavudine treated infants were low neutrophils in 7%, low hemoglobin in 1%, ALT increase in 1% and no lipase abnormality.
Croatian: Relevantne abnormalnosti 3-4. stupnja u laboratorijskim nalazima u 91 dojenčeta liječenog stavudinom uključivala su niske neutrofile u 7%, nizak hemoglobin u 1%, porast ALT u 1%, uz odsutnost odstupanja lipaze.
English: Patients with a history of neuropathy, or with other risk factors (for example alcohol, medicines such as isoniazid) are at particular risk.
Croatian: U bolesnika koji su bolovali od neuropatije ili imaju druge čimbenike rizika (na primjer, alkoholizam ili uzimanje lijekova kao što je izonijazid) taj je rizik osobito visok.
English: Caution should be exercised when administering stavudine to any patient (particularly obese women) with hepatomegaly, hepatitis or other known risk factors for liver disease and hepatic steatosis (including certain medicinal products and alcohol).
Croatian: Potreban je oprez kod davanja stavudina bilo kojem bolesniku (posebno pretilim ženama) s hepatomegalijom, hepatitisom ili drugim poznatim čimbenicima rizika za bolest jetre i steatozu jetre (uključujući određene medicinske proizvode i alkohol).
English: Macrocytosis was not evaluated in these trials, but was found to be associated with Zerit in an earlier trial (MCV > 112 fl occurred in 30% of patients treated with Zerit).
Croatian: Pojava makrocitoze nije procjenjivana u ovim ispitivanjima, ali je uočena povezanost s lijekom Zerit u jednom ranijem ispitivanju (MCV > 112 fl je nađen u 30% bolesnika liječenih lijekom Zerit).
English: Clinically significant interactions of stavudine or stavudine plus didanosine with nelfinavir have not been observed.
Croatian: Klinički značajne interakcije stavudina ili stavudina plus didanozina s nelfinavirom nisu opažene.
English: An ex vivo study using a term human placenta model demonstrated that stavudine reaches the foetal circulation by simple diffusion.
Croatian: Ex vivo ispitivanje u kojem je korišten model zrele ljudske placente pokazalo je da stavudin ulazi u cirkulaciju fetusa jednostavnom difuzijom.
English: LIST OF EXCIPIENTS Sucrose and preservatives (E218 and E216)
Croatian: 3. POPIS POMOĆNIH TVARI Saharoza i konzervansi (E218 i E216)
English: Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Croatian: Znakovi osteonekroze su ukočenost zglobova, bolovi i bolna stanja (naročito u kukovima, koljenima i ramenima) i otežana pokretljivost.
English: Patients were primarily males (76%) and white (66%) with a median age of 34 years (range 22 to 67 years).
Croatian: Bolesnici su bili većinom muškarci (76%) i bijelci (66%) sa medijanom dobi od 34 godine (raspon od 22 do 67 godina).
English: These are used to treat Human Immunodeficiency Virus (HIV) infection.
Croatian: Namijenjen je za liječenje infekcije virusom humane imunodeficijencije (HIV).
English: Stavudine treatment can select for and/or maintain thymidine analogue mutations (TAMs) associated with zidovudine resistance.
Croatian: Liječenje stavudinom može selektirati i/ili održavati mutacije analoga timidina (TAM) koje su povezane s rezistencijom na zidovudin.
English: The corresponding values after oral single and multiple dose administration are 35% (range: 8% to 72%) and 40% (range: 12% to 82%), respectively.
Croatian: Odgovarajuća vrijednosti nakon primjene jednostruke oralne doze iznosi 35% (raspon: 8% do 72%), a nakon višestruke doze 40% (raspon: 12% do 82%).
English: After intravenous administration, 42% (range: 13% to 87%) of dose is excreted unchanged in the urine.
Croatian: Nakon intravenske primjene, 42% (raspon: 13% do 87%) doze izluči se u neizmijenjenom obliku u mokraći.
English: Mitochondrial dysfunction following exposure in utero: nucleos(t)ide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.
Croatian: Poremećaj funkcije mitohondrija nakon izloženosti in utero: analozi nukleoz(t)ida mogu utjecati u različitom stupnju na funkciju mitohondrija, što je najizraženije sa stavudinom, didanozinom i zidovudinom.
English: In vitro, stavudine triphosphate has an intracellular half-life of 3.5 hours in CEM T-cells (a human T-lymphoblastoid cell line) and peripheral blood mononuclear cells, supporting twice daily dosing.
Croatian: In vitro, unutarstanični poluvijek stavudin trifosfata je 3,5 sati u CEM T-stanicama (linija ljudskih T-limfoblastoidnih stanica) i mononuklearima u perifernoj krvi, što govori u prilog doziranju dvaput dnevno.
English: When such development is found, discontinuation of Zerit should be considered.
Croatian: Kad se pronađe razvoj takvih promjena, mora se razmotriti prekid primjene lijeka Zerit.
English: uncommon: arthralgia, myalgia
Croatian: manje često: artralgija, mialgija
English: Binding of stavudine to serum proteins was negligible over the concentration range of 0.01 to 11.4 µg/ml.
Croatian: Vezanje stavudina na serumske proteine bilo je neznatno u rasponu koncentracija 0,01do 11,4 μg/ml.
English: The results of AI455-099 and AI455-096 are presented in Table 1.
Croatian: Rezultati AI455-099 i AI455-096 ispitivanja prikazani su u Tablici
English: Lactic acidosis has a high mortality and may be associated with pancreatitis, liver failure, renal failure, or motor paralysis.
Croatian: Laktična acidoza ima visoku smrtnost i može biti udružena s pankreatitisom, zatajenjem jetre, zatajenjem bubrega ili motornom paralizom.
English: Renal impairment: the following dosages are recommended
Croatian: Oštećenje bubrega: preporučuju se sljedeće doze
English: Do not store the dry powder above 30°C.
Croatian: Ne čuvati suhi prašak na temperaturi iznad 30°C.
English: Patients at increased risk should be followed closely (see also section 4.6).
Croatian: Bolesnike s povišenim rizikom treba pomno pratiti (vidjeti dio 4.6).
English: adult dosing *The reduced posology in neonates from 0 to 13 days is based on average study data and may not correspond to invidual variation in kidney maturation.
Croatian: *Smanjeno doziranje u novorođenčadi starosti od 0 do 13 dana temelji se na prosječnim podacima ispitivanja i ne moraju odgovarati individualnim razlikama u sazrijevanju bubrega.
English: However, clinically significant peripheral neuropathy is less frequent.
Croatian: Međutim, klinički značajna periferna neuropatija bila je rjeđa.
English: Zerit contains sucrose and preservatives
Croatian: Zerit sadrži saharozu i konzervanse
English: When these signs occur, Zerit should be stopped and your HIV treatment changed.
Croatian: Kad se pojave ti znakovi, potrebno je prekinuti primjenu lijeka Zerit i promijeniti Vaše liječenje HIV-a.
English: Treatment with stavudine should be discontinued if there is symptomatic hyperlactatemia and metabolic/lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels.
Croatian: Potrebno je prekinuti liječenje stavudinom u slučaju simptomatske hiperlaktemije i metaboličke/laktične acidoze, progresivne hepatomegalije ili brzo rastućih razina aminotransferaza.
English: This leaflet was last revised in {MM/YYYY}.
Croatian: Uputa je zadnji puta odobrena u {MM/GGGG}
English: 95% Confidence intervals for the mother-to-child-transmission rates were 5.4-19.3% (stavudine), 5.2-18.7% (didanosine); 1.3-11.2% (stavudine + didanosine); and 1.9-12.6% for zidovudine.
Croatian: 95%-tni interval pouzdanosti za stopu prijenosa majka-dijete iznosio je 5,4-19,3% (stavudin), 5,2-18,7% (didanozin), 1,3-11,2% (stavudin + didanozin), odnosno 1,9-12,6% za zidovudin.
English: Stavudine does not inhibit the major cytochrome P450 isoforms CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A4; therefore, it is unlikely that clinically significant drug interactions will occur with medicines metabolised through these pathways.
Croatian: Stavudin ne inhibira glavne izooblike citokroma P450 CYP1A2, CYP2C9, CYP2C19, CYP2D6 i CYP3A4; stoga, nije vjerojatno da će doći do klinički značajnih interakcija sa lijekovima koji se metaboliziraju ovim putem.
English: The solution should be dispensed with the measuring cup provided, or for doses less than 10 ml, dispense with a syringe.
Croatian: Otopina se mora izdavati s priloženom odmjernomčašicom, ili za doze manje od 10 ml, sa štrcaljkom.
English: In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Croatian: U nekih bolesnika s uznapredovalom HIV infekcijom (SIDA) i oportunističkim infekcijama u povijesti bolesti, znakovi i simptomi upala iz ranijih infekcija mogu se pojaviti ubrzo nakon početka liječenja HIV-a.
English: Both studies were designed to compare two formulations of Zerit, one of which was the marketed formulation dosed as currently approved in product labelling.
Croatian: Ova ispitivanja dizajnirana su u svrhu usporedbe dva oblika lijeka Zerit, od kojih je jedan bio u prometu s načinom doziranja prema trenutno odobrenoj uputi.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, javite se liječniku prije nego uzmete ovaj lijek.
English: Renal impairment: the clearance of stavudine decreases as creatinine clearance decreases; therefore, it is recommended that the dosage of Zerit be adjusted in patients with reduced renal function (see section 4.2).
Croatian: Oštećenje bubrega: klirens stavudina smanjuje se sa smanjenjem klirensa kreatinina; stoga se preporučuje prilagoditi dozu lijeka Zerit u bolesnika sa slabijom funkcijom bubrega (vidjeti dio 4.2).
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Croatian: B UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
English: Approximately 70% of the orally administered stavudine dose was excreted as an unchanged drug in urine.
Croatian: Oko 70% oralno primijenjene doze stavudina izlučilo se u neizmijenjenom obliku u mokraći.
English: Response to treatment with Zerit varies between patients.
Croatian: Odgovor na liječenje lijekom Zerit se razlikuje od bolesnika do bolesnika.
English: Zerit can cause a sometimes fatal condition called lactic acidosis, together with an enlarged liver.
Croatian: Zerit može dovesti do stanja koje može ponekad imati smrtni ishod, zvanog laktacidoza, zajedno s povećanom jetrom.
English: Stavudine distributes equally between red blood cells and plasma.
Croatian: Stavudin se raspodjeljuje jednako između eritrocita i plazme.
English: Stavudine was genotoxic in in vitro tests in human lymphocytes possessing triphosphorylating activity (in which no no-effect level was established), in mouse fibroblasts, and in an in vivo test for chromosomal aberrations.
Croatian: Stavudin je bio genotoksičan u in vitro testovima na humanim limfocitima koji posjeduju trifosforilirajuću aktivnost (u kojima razina bez učinka nije utvrđena), na mišjim fibroblastima, te u in vivo testu za kromosomske aberacije.
English: Store in the original package in order to protect from excessive moisture.
Croatian: Čuvati u originalnom pakiranju radi zaštite od pretjerane vlage.
English: To help protect the capsules from excessive moisture, the bottle includes a desiccant canister.
Croatian: Zbog zaštite kapsula od pretjerane vlage, u boci se nalazi sredstvo za sušenje.
English: For optimal absorption, Zerit should be taken on an empty stomach (i.e. at least 1 hour prior to meals) but, if this is not possible, it may be taken with a light meal.
Croatian: Za optimalnu apsorpciju, Zerit treba uzimati na prazan želudac (tj. najmanje 1 sat prije obroka) no, ukoliko to nije moguće, može se uzeti uz lagani obrok.
English: Mean renal clearance of the parent compound is approximately 272 ml/min, accounting for approximately 67% of the apparent oral clearance, indicating active tubular secretion in addition to glomerular filtration.
Croatian: Prosječni bubrežni klirens ishodnog spoja iznosi otprilike 272 ml/min, čineći otprilike 67% prividnog klirensa nakon oralne doze, što ukazuje na to da se uz glomerularnu filtraciju lijek izlučuje i aktivnom tubularnom sekerecijom.
English: Not recommended combinations: pancreatitis (fatal and nonfatal) and peripheral neuropathy (severe in some cases) have been reported in HIV infected patients receiving stavudine in association with hydroxyurea and didanosine (see section 4.3).
Croatian: Kombinacije koje se ne preporučuju: pankreatitis (sa i bez smrtnog ishoda) i periferna neuropatija (u nekim slučajevima teška) zabilježeni su u bolesnika s infekcijom HIV-om koji su primali stavudin zajedno s hidrokarbamidom i didanozinom (vidjeti dio 4.3).
English: Special consideration should be given to the antiretroviral treatment history and the resistance profile of the HIV strain of the mother.
Croatian: Posebnu pozornost valja obratiti na anamnezu antiretrovirusnog liječenja i profil rezistencije soja HIVvirusa u majke.
English: common: depression uncommon: anxiety, emotional lability
Croatian: često: depresija manje često: anksioznost, emocionalna labilnost
English: After multiple oral administration of 0.5-0.67 mg/kg doses, a Cmax value of 810±175 ng/ml was obtained.
Croatian: Nakon višestruke oralne primjene doza od 0,5-0,67 mg/kg, dobivena je Cmax vrijednost od 810±175 ng/ml.
English: If this is not possible, Zerit may also be taken with a light meal.
Croatian: Ako to nije moguće, tada se Zerit može uzeti s laganim obrokom.
English: No carcinogenicity was noted at doses of 400 mg/kg/day in mice and 600 mg/kg/day in rats, corresponding to exposures ~ 39 and 168 times the expected human exposure, respectively, suggesting an insignificant carcinogenic potential of stavudine in clinical therapy.
Croatian: Nikakva karcinogenost nije bila zabilježena kod doza od 400 mg/kg/dan u miševa i 600 mg/kg/dan u štakora, što odgovara izloženosti od oko ~ 39 odnosno 168 puta većoj od očekivane izloženosti čovjeka, što upućuje na neznačajan karcinogeni potencijal stavudina u kliničkim uvjetima.
English: Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Croatian: U bolesnika s prethodno postojećim poremećajem funkcije jetre, uključujući kronični aktivni hepatitis, povećana je učestalost poremećaja funkcije jetre za vrijeme kombinirane antiretrovirusne terapije te ih je stoga potrebno nadzirati u skladu sa standardnom praksom.