FrancophonIA/ELRC3.0 huggingface dataset:
English: Recent findings indicate that exposure in children <6 years of age may be reduced by about 30 % compared with other age groups.
Croatian: Najnoviji nalazi upućuju na to da se izloženost u djece ispod 6 godina može smanjiti za otprilike 30% u odnosu na druge starosne skupine.
English: • if their immune systems are very weak
Croatian: • ako je imunološki sustav vrlo oslabljen
English: Autoimmune disorders may occur many months after the start of treatment.
Croatian: Autoimuni poremećaji mogu se pojaviti mnogo mjeseci nakon početka liječenja.
English: Clinically significant interaction unlikely.
Croatian: Klinički značajna interakcija malo vjerojatna.
English: • if they are also taking anti-inflammatory medicines called corticosteroids
Croatian: • ako su također uzimali protuupalne lijekove nazvane kortikosteroidi
English: These include:
Croatian: Oni uključuju:
English: This medicine has been prescribed for you only.
Croatian: - Ovaj je lijek propisan Vama.
English: If you have any of the symptoms listed above, or any other symptoms that worry you:
Croatian: Ako imate bilo koji od gore navedenih simptoma ili bilo koje druge simptome koji Vas zabrinjavaju:
English: Do not take other medicines for the infection without your doctor's advice.
Croatian: Ne uzimajte druge lijekove za infekciju prije nego li se savjetujete s Vašim liječnikom.
English: Clinical Experience
Croatian: Kliničko iskustvo
English: If you're breast-feeding, or thinking about breast-feeding:
Croatian: Ako dojite ili ste razmišljali o dojenju:
English: • serious allergic reaction causing swelling of the face, tongue or throat which may cause difficulty in swallowing or breathing
Croatian: • ozbiljne alergijske reakcije koje uzrokuju oticanje lica, jezika ili grla što može dovesti do poteškoća u gutanju ili disanju
English: These symptoms are probably caused by the body's immune system becoming stronger, so that the body starts to fight these infections.
Croatian: Ti simptomi su vjerojatno uzrokovani jačanjem imunološkog sustava, kako bi tijelo započelo borbu s tim infekcijama.
English: Tell your doctor if you notice any loss of fat from your legs, arms, and face.
Croatian: Obavijestite svog liječnika ako primijetite bilo kakav gubitak masnog tkiva u Vašim nogama, rukama i licu.
English: You may still develop other infections and illnesses linked to HIV infection.
Croatian: No, Vi i nadalje možete razviti drugu infekciju ili bolesti povezane s HIV infekcijom.
English: CD4 cells are a type of white blood cells that are important in helping your body to fight infection.
Croatian: CD4 stanice su vrsta bijelih krvnih stanica koje imaju važnu ulogu pomaganja Vašem organizmu da se obrani od infekcije.
English: It is rare; if it happens, it usually develops after a few months of treatment.
Croatian: Rijetko se javlja, a ako se javi to je obično nakon nekoliko mjeseci liječenja.
English: Talk to your doctor immediately.
Croatian: Odmah razgovarajte s Vašim liječnikom.
English: Tell your doctor if you are taking phenytoin.
Croatian: Obavijestite svog liječnika ako uzimate fenitoin.
English: Containers:
Croatian: Spremnici:
English: Either of these two patterns of multinucleoside resistance mutations severely limits future therapeutic options.
Croatian: Bilo koji od ovih uzoraka mutacija nukleozidne rezistencije ozbiljno ograničavaju buduće terapijske opcije.
English: Abbreviations: ↑ = Increase; ↓=decrease; ↔= no significant change; AUC=area under the concentration versus time curve; Cmax=maximum observed concentration; CL/F=apparent oral clearance
Croatian: Skraćenice : ↑ = povišenje; ↓= sniženje; ↔= bez značajne promjene; AUC=područje ispod krivulje koncentracije u odnosu na vrijeme; Cmax=maksimalna opažena koncentracija; CL/F= prividni oralni klirens
English: • hair loss (alopecia).
Croatian: • gubitak kose (alopecija).
English: Methadone dosage adjustment unlikely in majority of patients; occasionally methadone retitration may be required.
Croatian: Potreba za prilagodbom doze za metadon je malo vjerojatna kod većine bolesnika; povremeno može biti potrebna retitracija metadona.
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Croatian: Ako postoje dokazi o pogoršanju bolesti jetre u tih bolesnika, mora se razmotriti privremeni ili trajni prekid liječenja.
English: No studies on the effects on the ability to drive and use machines have been performed.
Croatian: Nisu provedena ispitivanja učinka na sposobnost upravljanja vozilima i strojevima.
English: The list below should not be considered exhaustive but is representative of the classes studied.
Croatian: Niže navedeni popis ne bi se trebao smatrati kao konačan, već predstavlja ispitivane skupine lijekova.
English: • changes in the colour of your nails, your skin or the skin inside your mouth
Croatian: • promjene boje noktiju, kože ili unutrašnjosti usta
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
English: Old infections may flare up
Croatian: Stare infekcije mogu se ponovno javiti
English: 9/l (see section 4.2).
Croatian: 9/l (vidjeti dio 4.2).
English: Like all medicines, this medicine can cause side effects, but not everybody gets them.
Croatian: Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave, iako se one neće javiti kod svakoga.
English: For patients with advanced symptomatic HIV disease, it is generally recommended that blood tests are performed at least every two weeks for the first three months of therapy and at least monthly thereafter.
Croatian: Za bolesnike s uznapredovalom simptomatskom HIV bolesti, općenito se preporučuje provođenje krvnih pretraga najmanje svaka dva tjedna tijekom prva tri mjeseca terapije, a nakon toga najmanje jednom mjesečno.
English: Insufficient data to recommend dosage adjustment.
Croatian: Nedostatni podaci za preporuku prilagodbe doze.
English: Zidovudine plasma protein binding is 34 % to 38 %.
Croatian: Zidovudin se veže za proteine plazme u rasponu od 34% do 38%.
English: It can be life-threatening, causing failure of internal organs.
Croatian: Može postati po život opasna, uzrokujući zatajenje unutarnjih organa.
English: HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles).
Croatian: HIV infekcija se širi putem spolnog kontakta s nekim tko ima infekciju ili putem prijenosa zaraženom krvlju (npr. dijeljenjem igala za injekciju).
English: - if you are allergic to lamivudine or zidovudine or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na lamivudin ili zidovudin ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6)
English: Signs of osteonecrosis include:
Croatian: Znakovi osteonekroze uključuju:
English: Consideration should be given to replacing zidovudine in a combination ART regimen if this is already established.
Croatian: Trebalo bi razmotriti zamjenu zidovudina u kombiniranom ART režimu liječenja ako je on već započeo.
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare
Croatian: Prema učestalosti nuspojave su definirane kao vrlo česte (≥1/10), česte (≥1/100 do <1/10), manje česte (≥1/1000 do <1/100), rijetke (≥1/10 000 do <1/1000) i vrlo rijetke (<1/10 000).
English: Additionally, lamivudine has activity against hepatitis B virus (HBV).
Croatian: Dodatno, lamivudin pokazuje aktivnost protiv virusa hepatitisa B (HBV).
English: Pharmacotherapeutic group: Antivirals for treatment of HIV infections, combinations, ATC Code: J05AR01
Croatian: Farmakoterapijska skupina: Antivirotici za liječenje HIV infekcije, kombinacije, ATK oznaka: J05AR01.
English: Depending on the overall condition of the patient, blood tests may be performed less often, for example every one to three months.
Croatian: Ovisno o općem stanju bolesnika, krvne pretrage se mogu rjeđe provoditi; npr. svakih jedan do tri mjeseca.
English: • methadone, used as a heroin substitute
Croatian: • metadon, koji se primjenjuje kao nadomjesna terapija za heroin
English: Zidovudine had a similar effect in both species, but only at very high systemic exposures.
Croatian: Zidovudin ima sličan učinak u obje vrste, no samo pri visokoj sistemskoj izloženosti.
English: Therefore, there is little potential for interactions with antiretroviral protease inhibitors, non-nucleosides and other medicinal products metabolised by major P450 enzymes.
Croatian: Stoga postoji nizak potencijal za interakcije s antiretrovirusnim inhibitorima proteaze, nenukleozidima i ostalim lijekovima koji se metaboliziraju putem glavnih P450 enzima.
English: The effect of food on the rate and extent of absorption was also studied.
Croatian: Također je ispitivan učinak hrane na brzinu i opseg apsorpcije.
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: Ukoliko primijetite bilo koji simptom infekcije ili druge simptome kao što su mišićna slabost, slabost koja počinje u rukama i nogama i kreće se prema trupu tijela, lupanje srca, tremor i hiperaktivnost, javite se odmah svom liječniku kako bi dobili potrebno liječenje.
English: It also increases the CD4 cell count in your blood.
Croatian: Istodobno povećava broj CD4 stanica u Vašem tijelu.
English: Monitor phenytoin concentrations.
Croatian: Nadzor nad koncentracijama fenitoina.
English: The second study thus provided no evidence that zidovudine acts as a transplacental carcinogen.
Croatian: Drugo ispitivanje tako nije pružilo dokaze da bi zidovudin djelovao kao transplacentarni kancerogen.
English: These haematological effects are not usually observed before four to six weeks therapy.
Croatian: Ovi učinci na hematološki sustav se obično ne javljaju tijekom prvih 4-6 tjedana liječenja.
English: While the clinical relevance of these findings is unknown, these data suggest that a carcinogenic risk to humans is outweighed by the potential clinical benefit.
Croatian: Iako klinički značaj ovih nalaza nije poznat, podaci ukazuju na to da je potencijalna klinička korist veća od kancerogenog rizika kod ljudi.
English: Lamivudine and zidovudine are not significantly metabolised by cytochrome P450 enzymes (such as CYP 3A4, CYP 2C9 or CYP 2D6) nor do they inhibit or induce this enzyme system.
Croatian: Lamivudin i zidovudin se ne metaboliziraju značajno putem enzima citokroma P450 (kao što je CYP 3A4, CYP 2C9 ili CYP 2D6) niti oni inhibiraju ili induciraju ovaj enzimatski sustav.
English: In vitro susceptibility testing has not been standardised and results may vary according to methodological factors.
Croatian: Testovi osjetljivosti in vitro nisu standardizirani i rezultati mogu varirati ovisno o primijenjenoj metodi.
English: Drugs by Therapeutic Area Interaction Geometric mean change (%) (Possible mechanism)
Croatian: Geometrijska sredina promjene (%) (Mogući mehanizam)
English: Sorbitol solution (3.2g , 10.2 g, 13.4 g)/ Lamivudine
Croatian: otopina sorbitola (3,2 g, 10,2 g, 13,4 g)/lamivudin
English: If you accidentally take too much Lamivudine/Zidovudine Teva, tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice.
Croatian: Ako slučajno uzmete previše Lamivudina/Zidovudina Teva, obavijestite svog liječnika ili ljekarnika ili se javite za savjet u hitnu službu najbliže bolnice.
English: With this condition, parts of the bone tissue die because of reduced blood supply to the bone.
Croatian: U tom stanju dijelovi koštanog tkiva odumiru zbog smanjene opskrbe kosti krvlju.
English: Psychiatric disorders Rare: Anxiety and depression
Croatian: Psihijatrijski poremećaji Rijetko: anksioznost i depresija
English: The adverse reactions profile appears similar for adults and adolescents.
Croatian: Profil nuspojava je sličan u odraslih i u adolescenata.
English: Zidovudine AUC ↓12%
Croatian: zidovudin AUC ↓12%
English: Tell your doctor.
Croatian: Vašeg liječnika.
English: After administration of a single dose of 200 mg zidovudine to HIV-infected women, the mean concentration of zidovudine was similar in human milk and serum.
Croatian: Nakon primjene jedne doze od 200 mg zidovudina ženama zaraženim HIV-om, srednja koncentracija zidovudina bila je slična u ljudskom mlijeku i u serumu.
English: • if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection, do not stop Lamivudine/Zidovudine Teva without your doctor's advice, as your hepatitis may come back)
Croatian: • ako ste ikada bolovali od bolesti jetre, uključujući hepatitis B ili C (ako imate infekciju hepatitisa B nemojte prestajati uzimati Lamivudin/Zidovudin Teva bez prethodnog savjetovanja s Vašim liječnikom, jer bi se hepatitis mogao vratiti)
English: Lamivudine/Zidovudine Teva does not completely cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level.
Croatian: Lamivudin/Zidovudin Teva ne liječi u potpunosti infekciju HIV-om, već smanjuje količinu virusa u Vašem tijelu i održava je na niskoj razini.
English: The dosing regimen for paediatric patients weighing 14-30 kg is based primarily on pharmacokinetic modelling and supported by data from clinical studies using the individual components lamivudine and zidovudine.
Croatian: Režim doziranja za pedijatrijske bolesnike tjelesne težine od 14-30 kg se temelji prvenstveno na farmakokinetičkim modelima i podržan je podacima iz kliničkih studija s pojedinačnim komponentama lamivudinom i zidovudinom.
English: This dose will achieve an average AUC0-12 ranging from approximately 3,800 to 5,300 ng h/ml.
Croatian: Ta će doza postići prosječni AUC0-12 u rasponu 3800-5300 ng h/ml.
English: Teva UK Limited Tel: +44 1977628500
Croatian: United Kingdom Teva UK Limited Tel: +44 1977628500
English: Teva Denmark A/S Tlf: +45 44 98 55 11
Croatian: Danmark Teva Denmark A/S Tlf: +45 44 98 55 11
English: Your doctor should monitor for signs of lipoatrophy.
Croatian: Vaš liječnik treba nadzirati znakove lipoatrofije.
English: The bioavailability of oral lamivudine in adults is normally between 80-85 % and for zidovudine 60-70 %.
Croatian: Bioraspoloživost oralnog lamivudina u odraslih normalno iznosi između 80-85%, a bioraspoloživost zidovudina 60-70%.
English: • an increased amount in the blood of bilirubin (a substance produced in the liver) which may make your skin appear yellow.
Croatian: • povišenje razine bilirubina (tvar koja se stvara u jetri) u krvi što može činiti Vašu kožu žutom.
English: Each pack type contains 60 film-coated tablets.
Croatian: Obje vrste pakovanja sadrže 60 filmom obloženih tableta.
English: Pharmacokinetics in pregnancy: The pharmacokinetics of lamivudine and zidovudine were similar to that of non-pregnant women.
Croatian: Farmakokinetika u trudnoći: Farmakokinetička svojstva lamivudina i zidovudina su slična onima u žena koje nisu trudne.
English: • lactic acidosis (excess lactic acid in the blood; see the next section, ‘Other possible side effects of combination therapy for HIV')
Croatian: • laktacidoza (nakupljanje mliječne kiseline u krvi; pogledajte sljedeći odjeljak „Ostale moguće nuspojave kombinirane terapije HIV-a“)
English: If overdosage occurs the patient should be monitored for evidence of toxicity (see section 4.8), and standard supportive treatment applied as necessary.
Croatian: Ako dođe do predoziranja, potrebno je nadzirati bolesnika kako bi se uočili znakovi toksičnosti (vidjeti dio 4.8.), kao i primijeniti uobičajene mjere suportivnog liječenja, ukoliko se za to ukaže potreba.
English: Lactic acidosis generally occurred after a few or several months of treatment.
Croatian: Laktacidoza se obično pojavljivala nakon nekoliko mjeseci liječenja.
English: • an increase in an enzyme called amylase
Croatian: • povišena razina enzima koji se zovu amilaze
English: Systemic exposures (daily AUC and Cmax) in plasma from the twice daily regimen appeared equivalent to those from the same total daily dose given in three divided doses [Bergshoeff, 2004].
Croatian: Sistemska izloženost (dnevni AUC i Cmax) u plazmi nakon primjene lijeka dvaput dnevno pokazala se ekvivalentnom ukupnoj dnevnoj dozi primijenjenoj u tri zasebne doze [Bergshoeff, 2004].
English: Breast-feeding Women who are HIV-positive must not breastfeed, because HIV infection can be passed on to the baby in breast milk.
Croatian: Žene koje su HIV-pozitivne ne smiju dojiti, zbog toga što se HIV infekcija može prenijeti na dojenče putem majčina mlijeka.
English: Due to these differences, the recommended dose for lamivudine in children (aged more than three months and weighing less than 30 kg) is 4 mg/kg twice a day.
Croatian: Temeljem tih razlika, preporučena doza lamivudina u djece (starije od 3 mjeseca i tjelesne težine manje od 30 kg) je 4 mg/kg u dvije dnevne doze.
English: For the full list of excipients see section 6.1.
Croatian: Za cjeloviti popis pomoćnih tvari, vidjeti dio 6.1.
English: Neither zidovudine nor lamivudine have shown evidence of impairment of fertility in studies in male and female rats.
Croatian: Niti zidovudin niti lamivudin nisu pokazali dokaze za oštećenje fertiliteta u studijama na mužjacima ili ženkama štakora.
English: The incidence and severity of lipoatrophy are related to cumulative exposure.
Croatian: Incidencija i težina lipoatrofije povezane su s kumulativnom izloženosti lijeku.
English: Blood and lymphatic systems disorders
Croatian: Poremećaji krvi i limfnog sustava
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Croatian: Detaljne informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: Resistance to thymidine analogues (of which zidovudine is one) is well characterised and is conferred by the stepwise accumulation of up to six specific mutations in the HIV reverse transcriptase at codons 41, 67, 70, 210, 215 and 219.
Croatian: Rezistencija na analoge timidina (zidovudin je jedan od njih) je dobro karakterizirana stupnjevitom akumulacijom do 6 specifičnih mutacija na HIV reverznoj transkriptazi, na kodonima 41, 67, 70, 210, 215 i 219.
English: Clinical studies have shown that there are no clinically significant interactions between lamivudine and zidovudine.
Croatian: Kliničke studije su pokazale da ne postoje klinički značajne interakcije između lamivudina i zidovudina.
English: If you are pregnant, if you become pregnant or if you are planning to become pregnant talk to your doctor about the risks and benefits to you and your baby of taking Lamivudine/Zidovudine Teva.
Croatian: Ako ste trudni, ako ostanete trudni ili planirate trudnoću, porazgovarajte sa svojim liječnikom o mogućim nuspojavama te koristima i rizicima liječenja Lamivudinom/Zidovudinom Teva za Vas i Vaše dijete.
English: Lactic acidosis is caused by a build up of lactic acid in the body.
Croatian: Laktacidoza je uzrokovana nakupljanjem mliječne kiseline u tijelu.
English: A pilot study has demonstrated that zidovudine is incorporated into leukocyte nuclear DNA of adults, including pregnant women, taking zidovudine as treatment for HIV-1 infection, or for the prevention of mother to child viral transmission.
Croatian: Jedno pilot ispitivanje pokazalo je da se zidovudin inkorporirao u DNK jezgre leukocita u odraslih osoba, uključujući trudnice, koji se liječe zidovudinom zbog HIV-1 infekcije ili radi prevencije prijenosa virusa s majke na dijete.
English: One year post-natally, there was an increase in the incidence of tumours in the lung, liver and female reproductive tract of offspring exposed to the highest dose level (420 mg/kg term body weight).
Croatian: Godinu dana po okotu, uočen je porast incidencije neoplazmi pluća, jetre i ženskog reproduktivnog sustava u potomaka izloženih najvišoj dozi (420 mg/kg tjelesne težine pri okotu).
English: • muscle pain and discomfort
Croatian: • mišićna bol i neugoda
English: In vitro antagonism of anti-HIV activity between stavudine and zidovudine could result in decreased efficacy of both drugs.
Croatian: In vitro antagonizam anti-HIV aktivnosti između stavudina i zidovudina može rezultirati sniženom djelotvornosti za oba lijeka
English: A large amount of data on pregnant women taking lamivudine or zidovudine indicate no malformative toxicity (more than 3000 outcomes from first trimester exposure each of which over 2000 outcomes involved exposure to both lamivudine and zidovudine).
Croatian: Velika količina podataka koja se odnosi na trudne žene koje su uzimale lamivudin ili zidovudin ukazuje da ne postoji malformacijska toksičnost (više od 3000 ishoda za izloženost tijekom prvog trimestra, od kojih je preko 2000 ishoda uključivalo izloženost i lamivudinu i zidovudinu).
English: This conclusion is based on the physicochemical and pharmacokinetic data assuming that the patient crushes and transfers 100 % of the tablet and ingests immediately.
Croatian: Ovi se zaključci temelje na fizikalno-kemijskim i farmakokinetičkim podacima, ali pod pretpostavkom da je bolesnik u odmah uzeo 100% zdrobljene tablete.
English: Some people taking combination therapy for HIV develop a condition called osteonecrosis.
Croatian: Neki bolesnici koji uzimaju kombiniranu terapiju za HIV razvijaju stanje koje se zove osteonekroza.
English: Two patterns of multi-drug resistance mutations, the first characterised by mutations in the HIV reverse transcriptase at codons 62, 75, 77, 116 and 151 and the second involving a T69S mutation plus a 6-base pair insert at the same position, result in phenotypic resistance to AZT as well as to the other approved NRTIs.
Croatian: Dva su uzorka mutacija za rezistenciju na veliki broj lijekova: prvi karakterizira mutacija HIV reverzne transkriptaze na kodonima 62, 75, 77, 116 i 151, a druga uključuje mutaciju T69S uz umetanje 6-baznih parova na istom mjestu, što za posljedicu ima fenotipsku rezistenciju na AZT kao i na druge registrirane nukleozidne inhibitore reverzne transkriptaze.
English: This loss of body fat has been shown to be not fully reversible after discontinuation of zidovudine.
Croatian: Taj gubitak tjelesne masti nije se potpuno oporavio nakon prekidanja liječenja zidovudinom.
English: Based on more than 200 mother/child pairs treated for HIV, serum concentrations of lamivudine in breastfed infants of mothers treated for HIV are very low (< 4% of maternal serum concentrations) and progressively decrease to undetectable levels when breastfed infants reach 24 weeks of age.
Croatian: Na temelju više od 200 parova majka/dijete liječenih zbog HIV infekcije, serumske koncentracije lamivudina u dojenčadi čije su majke liječene zbog HIV infekcije su vr lo ni ske ( < 4% serumskih koncentracija u majke) i progresivno se smanjuju do nemjerljivih razina nakon što dojenče navrši 24 tjedna.
English: • vincristine, vinblastine or doxorubicin, to treat cancer.
Croatian: • vinkristin, vinblastin ili doksorubicin, za liječenje karcinoma.
English: Lamivudine and zidovudine are well absorbed from the gastrointestinal tract.
Croatian: Lamivudin i zidovudin se dobro apsorbiraju iz gastrointestinalnog trakta.
English: In addition, systemic clearance values were greater in younger paediatric patients and decreased with age, approaching adult values around 12 years of age.
Croatian: Uz to su vrijednosti sistemskog klirensa veće u mlađih pedijatrijskih bolesnika i opadaju s dobi, te dosežu vrijednosti kao u odraslih oko dvanaeste godine života.