FrancophonIA/ELRC3.0 huggingface dataset:
English: What Trizivir is and what it is used for
Croatian: Što je Trizivir i za što se koristi
English: Take the tablets at regular times, leaving approximately 12 hours between each tablet.
Croatian: Tablete uzimajte redovito tako da između svake tablete imate približno 12 sati.
English: Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Croatian: Ovakve reakcije su tipično zabilježene u prvih nekoliko tjedana ili mjeseci po uvođenja KART-a.
English: Date of latest renewal: 2 January 2011
Croatian: Datum posljednje obnove odobrenja: 2. siječnja 2011.
English: Your methadone dose may need to be changed.
Croatian: Vaša doza metadona će se možda trebati prilagoditi.
English: Trizivir can also cause:
Croatian: Trizivir može isto tako uzrokovati:
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: If you have stopped taking Trizivir for any reason - especially because you think you are having side effects, or because you have other illness:
Croatian: Ako ste prestali uzimati Trizivir iz bilo kojeg razloga - posebice zato što mislite da imate nuspojave ili neku drugu bolest:
English: Detach this card and keep it with you at all times.
Croatian: Odvojite tu karticu i nosite je uvijek sa sobom.
English: These measures help protect the environment.
Croatian: Ove će mjere pomoći u očuvanju okoliša.
English: • if they are also taking anti-inflammatory medicines called corticosteroids
Croatian: • ako su isto tako uzimali protuupalne lijekove zvane kortikosteroidi
English: Criteria to be used to verify the success of proposed risk minimisation activity: Implementation of the education program will be monitored by the MAH via auditing.
Croatian: Kriteriji koji će se koristiti za provjeru uspjeha predložene mjere minimalizacije rizika: Implementacija edukacijskog programa će se pratiti kroz revizije od strane nositelja odobrenja.
English: Tell your doctor if you have heart problems, if you smoke, or have other illnesses that may increase your risk of heart disease such as high blood pressure, or diabetes.
Croatian: Obavijestite svog liječnika ako imate problema sa srcem, ako pušite ili imate bolesti koje mogu povećati rizik za srčanu bolest kao što su visoki krvni tlak ili dijabetes.
English: “Pull here” (with Alert card attached)
Croatian: ''Povucite ovdje'' ( sa pričvršćenom Karticom s upozorenjem)
English: In vitro resistance
Croatian: In vitro rezistencija
English: ( see reverse of card)
Croatian: (pogledajte drugu stranu kartice)
English: No unexpected adverse reactions were reported.
Croatian: Nisu prijavljene neočekivane nuspojave.
English: Grunwaldzka 189 , 60-322 Poznan, Poland
Croatian: Grunwaldzka 189 , 60-322 Poznan, Poljska
English: • deep, rapid, difficult breathing
Croatian: • duboko, ubrzano i otežano disanje
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 Trizivir during your pregnancy.
Croatian: Ako ste trudni, ako zatrudnite ili ako planirate trudnoću, razgovarajte odmah sa svojim liječnikom o mogućim koristima i rizicima za Vas i Vaše dijete zbog uzimanja lijeka Trizivir tijekom trudnoće.
English: Do not take Trizivir:
Croatian: Nemojte uzimati Trizivir:
English: See sections 4.4 and 4.8
Croatian: Vidjeti dijelove 4.4 i 4.8.
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 rezultata nije poznat, ovi podaci upućuju da potencijalna klinička korist nadmašuje karcinogeni rizik za ljude.
English: Hertfordshire, SG 12 0DJ, UK
Croatian: Hertfordshire, SG 12 0DJ, Velika Britanija
English: • methadone, used as a heroin substitute
Croatian: • metadon, koji se koristi kao nadomjesna terapija za heroin
English: The choice of this fixed combination should be based not only on potential adherence criteria, but mainly on expected efficacy and risk related to the three nucleoside analogues.
Croatian: Odabir ove fiksne kombinacije treba se temeljiti ne samo na kriteriju potencijalnog pridržavanja uzimanja lijeka, nego ponajviše na očekivanoj djelotvornosti i riziku povezanim s tri analoga nukleozida.
English: Zidovudine plasma protein binding is 34 % to 38 %.
Croatian: Vezanje zidovudina na proteine plazme iznosi 34% do 38%.
English: CD4 cells are a type of white blood cell 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 u obrani od infekcije.
English: What you need to know before you take Trizivir
Croatian: Što morate znati prije nego počnete uzimati Trizivir
English: Not everyone responds to treatment with Trizivir in the same way.
Croatian: Ne odgovaraju svi bolesnici na liječenje lijekom Trizivir na isti način.
English: Due to the high proportion of premature discontinuation (42 % of patients discontinued randomised treatment by week 48), no definitive conclusion can be drawn regarding the equivalence between the treatment regimens at week 48.
Croatian: S obzirom na visok udio ranijeg prekida (42% bolesnika je do 48. tjedna prekinulo uzimanje randomizirane terapije), nije bilo moguće donijeti definitivne zaključke o jednakosti učinaka terapijskih režima u 48. tjednu.
English: The usual dose of Trizivir for adults is one tablet twice a day.
Croatian: Uobičajena doza lijeka Trizivir za odrasle je jedna tableta dvaput na dan.
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, pri čemu tijelo započinje borbu s tim infekcijama.
English: • tiredness, lack of energy
Croatian: • umor, nedostatak energije
English: Clinical diagnosis of suspected hypersensitivity to ABC remains the basis for clinical decision making.
Croatian: Klinička dijagnoza suspektne preosjetljivosti na ABC ostaje temelj kliničkog odlučivanja.
English: Trizivir and similar medicines may cause side effects in unborn babies.
Croatian: Trizivir i slični lijekovi mogu uzrokovati nuspojave u nerođene djece.
English: If you know you have this gene, tell your doctor before you take Trizivir.
Croatian: Ako znate da imate taj gen, obavijestite svog liječnika prije uzimanja lijeka Trizivir.
English: If you have taken Trizivir during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Croatian: Ako ste Trizivir uzimali tijekom trudnoće, postoji mogućnost da liječnik zatraži redovito provođenje pretraga krvi i drugih dijagnostičkih pretraga kako bi pratio razvoj vašega djeteta.
English: What Trizivir contains
Croatian: Što Trizivir sadrži
English: These adverse reactions have often been transitory.
Croatian: Ti su događaji često bili prolazni.
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 planu liječenja ako je on već započeo.
English: You are more likely to develop such a reaction if you have a gene called HLA-B*5701 (but you can get a reaction even if you do not have this gene).
Croatian: Prije ćete razviti takvu reakciju ako imate gen pod nazivom HLA-B*5701 (ali možete dobiti ovakvu reakciju i ako nemate taj gen).
English: • if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection, do not stop Trizivir without your doctor's advice, as your hepatitis may come back)
Croatian: • ako ste nekada imali bolest jetre, uključujući hepatitis B ili C (ako imate infekciju virusom hepatitisa B, nemojte prestajati uzimati Trizivir bez prethodnog savjetovanja sa svojim liječnikom jer bi se hepatitis mogao vratiti)
English: Rare: anxiety, depression
Croatian: Rijetko: anksioznost, depresija
English: Risk of heart attack
Croatian: Rizik od srčanog udara
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 zaražene krvi (npr. dijeljenjem igala za injekciju).
English: A small amount of the ingredients in Trizivir can also pass into your breast milk.
Croatian: Mala količina sastojaka lijeka Trizivir također može prijeći u majčino mlijeko.
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; ↓=smanjenje; ↔= bez značajne promjene; AUC=površina ispod krivulje koja označava koncentraciju u vremenu; Cmax=maksimalna zabilježena koncentracija; CL/F=prividni oralni klirens
English: If you take more Trizivir than you should
Croatian: Ako uzmete više lijeka Trizivir nego što ste trebali
English: If you are hypersensitive to Trizivir, return all your unused Trizivir tablets for safe disposal.
Croatian: Ako ste preosjetljivi na Trizivir, vratite sve neiskorištene tablete na sigurno odlaganje.
English: Haematological parameters should therefore be carefully monitored (see section 4.3) in patients receiving Trizivir.
Croatian: Stoga treba pažljivo pratiti hematološke parametre (vidjeti dio 4.3) u bolesnika koji dobivaju Trizivir.
English: • aches and pains (especially in the hip, knee or shoulder)
Croatian: • tupe bolove i probadanja (posebice u kuku, koljenu ili ramenu)
English: Do not take other medicines for the infection without your doctor's advice.
Croatian: Ne uzimajte druge lijekove za infekciju prije nego što se savjetujete sa svojim liječnikom.
English: Following discontinuation of abacavir, the symptoms of the reaction should be treated according to local standard of care.
Croatian: Nakon prekida terapije abakavirom, simptome reakcije treba liječiti u skladu s lokalnim standardima liječenja.
English: • a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling in more than
Croatian: • široko rasprostranjen osip s mjehurićima i ljuštenjem kože, posebice oko usta, nosa, očiju i genitalija (Stevens-Johnson sindrome), i u težim oblicima koji uzrokuju ljuštenje kože u više od
English: Your doctor may advise you to stop taking Trizivir.
Croatian: Liječnik Vas može savjetovati da prestanete uzimati Trizivir.
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 bolešću, preporučuje se provođenje krvnih pretraga u razmacima od najmanje dva tjedna tijekom prva tri mjeseca liječenja, a nakon toga jednom mjesečno.
English: The second study thus provided no evidence that zidovudine acts as a transplacental carcinogen.
Croatian: Druga studija tako nije pružila dokaze da bi zidovudin djelovao kao transplacentarni karcinogen.
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 mogu se rjeđe provoditi, npr. svakih jedan do tri mjeseca.
English: Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street,
Croatian: Glaxo Operations UK Ltd (posluje kao Glaxo Wellcome Operations), Priory Street,
English: A similar effect was not seen in rats even at very high systemic exposure.
Croatian: Taj učinak nije uočen u štakora čak i pri izuzetno visokoj sistemskoj izloženosti.
English: There are no additional precautions or warnings relevant to the combination Trizivir.
Croatian: Nema dodatnih mjera opreza i upozorenja relevantnih za kombinaciju u lijeku Trizivir.
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 webportal
Croatian: Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i objavljenima na europskom internetskom portalu za lijekove.
English: Median Change vRNA (log10 c/mL)
Croatian: Medijan promjene vRNK (log10 c/ml)
English: The recommended dose of Trizivir in adults (18 years and over) is one tablet twice daily.
Croatian: Preporučena doza lijeka Trizivir u odraslih (18 godina ili stariji) je jedna tableta dva puta na dan.
English: Women who are HIV-positive must not breast-feed, 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 dijete putem majčinog mlijeka.
English: • increase in an enzyme called amylase
Croatian: • povišena razina enzima koji se zove amilaza
English: Your doctor will check whether your symptoms were related to a hypersensitivity reaction.
Croatian: Liječnik će provjeriti jesu li Vaši simptomi bili povezani s reakcijom preosjetljivosti.
English: Based on the above patients are advised to contact their physician immediately to determine whether they should stop taking abacavir if:
Croatian: Temeljem gore navedenog, bolesnicima se preporučuje da se odmah obrate svojem liječniku kako bi se utvrdilo trebaju li prestati uzimati abakavir u slučaju:
English: If you accidentally take too much Trizivir, tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice.
Croatian: Ako slučajno uzmete previše lijeka Trizivir, obavijestite svog liječnika ili ljekarnika, ili se javite za savjet u hitnu službu najbliže bolnice.
English: Because insufficient data are available, the use of Trizivir in children or adolescents is not recommended.
Croatian: Budući da nisu dostupni dostatni podaci, ne preporučuje se uporaba lijeka Trizivir u djece i adolescenata.
English: Studies with abacavir demonstrate a CSF to plasma AUC ratio of between 30 to 44 %.
Croatian: Ispitivanja s abakavirom pokazuju omjer CST-a u odnosu na plazmatsku AUC između 30 do 44%.
English: There are no data on the use of Trizivir in pregnancy.
Croatian: Nema podataka o uporabi lijeka Trizivir u trudnica.
English: If your doctor advises that you can start taking Trizivir again, you may be asked to take your first doses in a place where you will have ready access to medical care if you need it.
Croatian: Ako Vam je liječnik savjetovao da ponovno počnete uzimati Trizivir, možda će Vas uputiti da prve doze uzmete na mjestu gdje Vam se u slučaju potrebe odmah može ukazati liječnička pomoć.
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: • increased levels of lactic acid in the blood, which on rare occasions can lead to lactic acidosis
Croatian: • povišene razine mliječne kiseline u krvi koje u rijetkim slučajevima mogu dovesti do laktacidoze
English: OTHER SPECIAL WARNING(S), IF NECESSARY Detach enclosed Alert Card, it contains important safety information WARNING!
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Odvojite priloženu Karticu s upozorenjem, jer sadrži važne sigurnosne informacije.
English: Lamivudine has not shown any genotoxic activity in the in vivo studies at doses that gave plasma concentrations up to 40 - 50 times higher than clinical plasma levels.
Croatian: Lamivudin nije pokazao nikakvu genotoksičnu aktivnost u studijama in vivo pri dozama koje uzrokuju koncentracije u plazmi do 40 - 50 puta više od kliničkih koncentracija.
English: • probenecid, to treat gout and similar conditions, and given with some antibiotics to make them more effective
Croatian: • probenecid, za liječenje gihta i sličnih stanja, te ako se uzima sa nekim antibioticima kako bi bio učinkovitiji
English: Percent with <400 copies/mL vRNA
Croatian: Postotak s <400 kopija/ml vRNA
English: Patients receiving Trizivir should be frequently examined and questioned for signs of lipoatrophy.
Croatian: Bolesnike koji primaju Trizivir potrebno je često pregledavati i pitati ih o znakovima lipoatrofije.
English: Do not stop taking Trizivir unless your doctor advises you to do so.
Croatian: Nemojte prestajati uzimati Trizivir, osim ako Vam to nije savjetovao liječnik.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskim stranicama Europske agencije za lijekove http://www.ema.europa.eu
English: The effects of higher doses are not known.
Croatian: Učinci većih doza nisu poznati.
English: A modest increase in Cmax (28 %) was observed for zidovudine when administered with lamivudine, however overall exposure (AUC) was not significantly altered.
Croatian: Umjereno povećanje vrijednosti Cmax (28%) zamijećeno je kod zidovudina kada je primjenjivan s lamivudinom, međutim, ukupna izloženost (AUC) nije se značajnije mijenjala.
English: Talk to your doctor before you start taking it again.
Croatian: Javite se svom liječniku prije nego ga ponovno počnete uzimati.
English: Trizivir helps to control your condition.
Croatian: Trizivir Vam pomaže u kontroli zdravstvenog stanja.
English: Lactic acidosis generally occurred after a few or several months of treatment.
Croatian: Laktacidoza se obično pojavila nakon nekoliko mjeseci liječenja.
English: • loss of appetite, weight loss
Croatian: • gubitak apetita, gubitak tjelesne težine
English: • an increased amount in the blood of bilirubin (a substance produced in the liver) which may make your skin appear yellow
Croatian: • povišena razina bilirubina (tvari koja se stvara u jetri) u krvi zbog koje Vam koža može izgledati žuta.
English: Therapy should be prescribed by a physician experienced in the management of HIV infection.
Croatian: Terapiju treba propisati liječnik s iskustvom u liječenju HIV infekcije.
English: The mean half-life of abacavir is about 1.5 hours.
Croatian: Srednja vrijednost poluvijeka abakavira je oko 1,5 sati.
English: Studies in animals showed that neither abacavir nor lamivudine nor zidovudine had any effect on fertility (see section 5.3).
Croatian: Ispitivanja na životinjama su pokazala da ni abakavir ni lamivudin ni zidovudin nisu imali nikakav učinak na fertilitet (vidjeti dio 5.3).
English: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Croatian: Svaki simptom upale se mora procijeniti i započeti liječenje ako je to potrebno.
English: Remember to tell your doctor or pharmacist if you begin taking a new medicine while you are taking Trizivir.
Croatian: Zapamtite da svakako obavijestite svog liječnika ili ljekarnika ako započnete uzimati nove lijekove dok uzimate istodobno Trizivir.
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 vrlo niske (< 4% serumskih koncentracija u majke) i progresivno se smanjuju do nemjerljivih razina nakon što dojenče navrši 24 tjedna.
English: Table 1: Adverse reactions reported with the individual components of Trizivir
Croatian: Tablica 1: Nuspojave prijavljene s pojedinačnim komponentama lijeka Trizivir
English: When such development is found, treatment with Trizivir should not be continued (see section 4.4).
Croatian: Kad se takav razvoj otkrije, ne smije se nastaviti liječenje lijekom Trizivir (vidjeti dio 4.4).
English: Management of ABC HSR reaction
Croatian: Zbrinjavanje ABC HSR reakcije
English: The effect of food on the rate and extent of absorption was also studied.
Croatian: Ispitivao se i učinak hrane na brzinu i omjer apsorpcije.
English: It is concluded that as the increase in incidence of tumours in the first transplacental carcinogenicity study represents a hypothetical risk, this should be balanced against the proven therapeutic benefit.
Croatian: Zaključeno je da povećanje incidencije tumora u prvom ispitivanju transplacentarne karcinogenosti predstavlja hipotetski rizik kojeg treba odmjeriti prema dokazanoj terapijskoj koristi.
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: 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 (< 1/10,000).
Croatian: <1/100), rijetke (>1/10 000 do <1/1000), vrlo rijetke (<1/10 000).
English: If you are taking methadone, you will be checked for any withdrawal symptoms.
Croatian: Ako uzimate metadon, bit ćete nadzirani zbog razvoja simptoma odvikavanja.
English: Monitor phenytoin concentrations.
Croatian: Pratiti koncentracije fenitoina.
English: The incidence and severity of lipoatrophy are related to cumulative exposure.
Croatian: Incidencija i težina lipoatrofije povezane su sa kumulativnom izloženosti lijeku.
English: Tell your doctor or pharmacist if you are taking any other medicines, or if you have taken any recently, including herbal medicines or other medicines you bought without a prescription.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove uključujući biljne lijekove i druge lijekove kupljenje bez recepta.
English: In case of any symptoms suggesting hypersensitivity reactions, contact your doctor IMMEDIATELY.
Croatian: U slučaju simptoma koji upućuju na reakciju preosjetljivosti ODMAH kontaktirajte svog liječnika.
English: Exacerbation of anaemia due to ribavirin has been reported when zidovudine is part of the regimen used to treat HIV although the exact mechanism remains to be elucidated.
Croatian: Pogoršanje anemije zbog ribavirina bilo je uočeno kada je zidovudin bio dio terapijskog plana kojim se liječio HIV iako se točan mehanizam treba ustanoviti.
English: Likewise, neither lamivudine nor zidovudine had any effect on fertility.
Croatian: Isto tako, ni lamivudin ni zidovudin nisu imali učinaka na plodnost.
English: In this study, addition of ABC to ZDV/3TC/EFV did not significantly improve efficacy.
Croatian: U tom ispitivanju dodatak ABC u kombinaciju ZDV/3TC/EFV nije značajno poboljšao djelotvornost.
English: In this patient population, hypersensitivity reactions are particularly difficult to identify.
Croatian: U tih bolesnika osobito je teško identificirati reakcije preosjetljivosti.
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 je pokazalo 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: Abacavir + Combivir
Croatian: Abakavir + Combivir
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 majčinom mlijeku i u serumu.