FrancophonIA/ELRC3.0 huggingface dataset:
English: Carefully read all the information about hypersensitivity reactions in Section 4 of this leaflet.
Croatian: Pozorno pročitajte sve informacije o reakcijama preosjetljivosti u dijelu 4 u ovoj Uputi.
English: Film-coated Tablets
Croatian: Filmom obložene tablete
English: The adapter is placed in the neck of the bottle and the syringe attached to this.
Croatian: Nastavak se postavi u grlo boce i štrcaljka se pričvrsti na nastavak.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL - ORAL SOLUTION
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA NA BOCI - ORALNA OTOPINA
English: Children weighing 14 to < 20 kg: The recommended dose is 300 mg daily.
Croatian: Djeca tjelesne težine od 14 do < 20 kg: Preporučena doza je 300 mg na dan.
English: The demonstration of the benefit of Ziagen is mainly based on results of studies performed in adult treatment-naïve patients using a regimen of Ziagen 300 mg twice daily in combination with zidovudine and lamivudine.
Croatian: Klinička djelotvornost i sigurnost Prikaz koristi lijeka Ziagen uglavnom se temelji na rezultatima studija provedenih u odraslih prethodno neliječenih bolesnika pri režimu doziranja od 300 mg lijeka Ziagen dvaput na dan u kombinaciji sa zidovudinom i lamivudinom.
English: (e.g.Triumeq, Trizivir or Kivexa).
Croatian: (npr. Triumeq, Trizivir ili Kivexa).
English: Package leaflet: Information for the user Ziagen 300 mg Film-coated tablets
Croatian: Uputa o lijeku: Informacije za korisnika Ziagen 300 mg filmom obložene tablete abakavir
English: If you have stopped taking Ziagen
Croatian: Ako ste prestali uzimati Ziagen
English: The Ziagen pack includes an Alert Card, to remind you and medical staff about abacavir hypersensitivity.
Croatian: Pakiranje lijeka Ziagen sadrži i Karticu s upozorenjem, kako bi podsjetila Vas i medicinsko osoblje na moguću preosjetljivost na abakavir.
English: Observational studies have shown an association between myocardial infarction and the use of abacavir.
Croatian: Infarkt miokarda Opservacijske studije su pokazale povezanost infarkta miokarda s uporabom abakavira.
English: None M184V alone Any one NRTI mutation 82 Any two NRTI-associated mutations Any three NRTI-associated mutations Four or more NRTIassociated mutations
Croatian: Bez mutacije Samo M184V Bilo koja pojedinačna mutacija NRTI Bilo koje dvije mutacije povezane s NRTI
English: If the doctor thinks they may have been, you will then be told never again to take Ziagen, or any other medicine containing abacavir (e.g. Trizivir , Triumeq or Kivexa).
Croatian: Ako liječnik misli da bi mogli biti povezani, bit će Vam rečeno da više nikad ne uzimate Ziagen ili bilo koji drugi lijek koji sadržava abakavir (npr. Triumeq, Trizivir ili Kivexa).
English: Ziagen oral solution is clear to yellowish in colour which may turn into a brown colour over time with strawberry/banana flavouring.
Croatian: Ziagen oralna otopina je bistra do žućkasta, a s vremenom može postati smeđe boje.
English: Adults, adolescents and children weighing at least 25 kg
Croatian: Koliku dozu uzeti Odrasli, adolescenti i djeca tjelesne težine najmanje 25 kg
English: 1 if you get a skin rash, OR
Croatian: Ziagen ako: dobijete osip po koži ILI
English: Number of subjects with ≥1 Thymidine Analogue Mutations (TAMs).
Croatian: Broj ispitanika s ≥1 mutacijom analoga timidina (TAMs, "Thymidine Analogue Mutations") IP- inhibitor proteaze
English: Appropriate use of abacavir can be guided using currently recommended resistance algorithms.
Croatian: Za pravilnu primjenu abakavira potrebno je slijediti važeće algoritme rezistencije.
English: Children from one year of age weighing less than 25 kg
Croatian: Djeca od navršenih godinu dana i tjelesne težine manje od 25 kg
English: The Ziagen pack includes an Alert Card, to remind you and medical staff about hypersensitivity reactions.
Croatian: Pakiranje lijeka Ziagen sadrži Karticu s upozorenjima, koja služi da Vas i zdravstvene djelatnike podsjeti na reakcije preosjetljivosti.
English: Kivexa).
Croatian: Trizivir).
English: • stiffness in the joints
Croatian: • krutost zglobova
English: Package leaflet: Information for the user Ziagen 20 mg/ml oral solution
Croatian: Uputa o lijeku: Informacije za korisnika Ziagen 20 mg/ml oralna otopina abakavir
English: K65R was absent and L74V and Y115F were uncommon (≤3%).
Croatian: dok su se L74V i Y115F javili manje često (≤3%).
English: Delay in stopping treatment with Ziagen after the onset of hypersensitivity may result in a life-threatening reaction.
Croatian: Odgađanje prekida liječenja lijekom Ziagen nakon nastupa preosjetljivosti može uzrokovati trenutačnu i po život opasnu reakciju.
English: Placental transfer of abacavir and/or its related metabolites has been shown to occur in human.
Croatian: Pokazalo se da u ljudi abakavir i/ili njegovi metaboliti prolaze kroz placentu.
English: Rarely, patients who have stopped abacavir for reasons other than symptoms of HSR have also experienced life-threatening reactions within hours of re- initiating abacavir therapy (see Section 4.8 Description of selected adverse reactions).
Croatian: U rijetkim su slučajevima po život opasne reakcije zabilježene unutar svega nekoliko sati nakon ponovnog uvođenja abakavira u bolesnika koji su liječenje abakavirom prekinuli zbog drugih razloga, a ne zbog simptoma reakcija preosjetljivosti (vidjeti dio 4.8 “Opis odabranih nuspojava”).
English: Combination therapy including Ziagen may cause other conditions to develop during HIV treatment.
Croatian: Ostale moguće nuspojave u kombiniranoj terapiji za HIV Kombinirana terapija koja uključuje Ziagen može uzrokovati druga stanja koja se mogu razviti za vrijeme liječenja HIV-a.
English: The other ingredients are microcrystalline cellulose, sodium starch glycollate, magnesium stearate and colloidal anhydrous silica in the core of the tablet.
Croatian: Drugi sastojci u jezgri tablete su mikrokristalična celuloza, natrijev škroboglikolat, magnezijev stearat i koloidni, bezvodni silicijev dioksid.
English: Ethanol: the metabolism of abacavir is altered by concomitant ethanol resulting in an increase in AUC of abacavir of about 41%.
Croatian: Etanol: Metabolizam abakavira se mijenja istovremenim uzimanjem etanola, što dovodi do povećanja
English: Abacavir is primarily metabolised by the liver with approximately 2% of abacavir excreted unchanged in the urine.
Croatian: Abakavir se primarno metabolizira putem jetre, a približno 2% abakavira se izlučuje urinom u nepromijenjenom obliku.
English: The oral solution is clear to slightly opalescent yellowish, aqueous solution which may turn into a brown colour over time
Croatian: Oralna otopina Oralna otopina je bistra do lagano opalescentno žućkasta vodena otopina koja s vremenom može postati smeđe boje.
English: IMPORTANT - Hypersensitivity reactions
Croatian: VAŽNO- Reakcije preosjetljivosti
English: • After stopping treatment with Ziagen for reasons of a suspected HSR, Ziagen or any other medicinal product containing abacavir (e.g. Kivexa, Trizivir, Triumeq) must never be reinitiated.
Croatian: • Nakon prekida liječenja lijekom Ziagen zbog suspektne reakcije preosjetljivosti, nikada se ne smije ponovno započeti liječenje lijekom Ziagen niti bilo kojim drugim lijekom koji sadrži abakavir (npr. Kivexa, Trizivir, Triumeq).
English: Therefore no dosage reduction is required in patients with renal impairment.
Croatian: Stoga nije potrebno smanjenje doze u bolesnika s oštećenjem funkcije bubrega.
English: • lactic acidosis (excess lactic acid in the blood)
Croatian: 30% površine tijela (toksična epidermalna nekroliza) • laktacidoza (nakupljanje mliječne kiseline u krvi)
English: Nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage.
Croatian: Pokazalo se da analozi nukleozida i nukleotida uzrokuju različite stupnjeve mitohondrijskog oštećenja in vitro i in vivo.
English: If a twice daily regimen is not feasible, a once daily regimen (16 mg/kg/day) could be considered.
Croatian: Ako režim primjene dvaput na dan nije moguće provesti, može se razmotriti režim primjene jedanput na dan
English: This can be taken either as one 300 mg tablet twice a day or two 300 mg tablets once a day.
Croatian: Ona se može uzeti kao jedna tableta od 300 mg dvaput na dan ili kao dvije tablete od 300 mg jedanput na dan.
English: In a multicentre, double-blind, controlled study (CNA30024), 654 HIV-infected, antiretroviral therapy-naïve patients were randomised to receive either abacavir 300 mg twice daily or zidovudine 300 mg twice daily, both in combination with lamivudine 150 mg twice daily and efavirenz 600 mg once daily.
Croatian: U multicentričnoj, dvostruko slijepoj, kontroliranoj studiji (CNA30024), 654 bolesnika zaraženih virusom HIV, koji još nisu bili liječeni antiretrovirusnim lijekovima, randomizirano je tako da su primali ili abakavir u dozi od 300 mg dvaput na dan, ili zidovudin u dozi od 300 mg dvaput na dan.
English: The active substance in Ziagen oral solution is 20 mg of abacavir (as sulfate) in each ml of the solution.
Croatian: Djelatna tvar u Ziagen oralnoj otopini je 20 mg abakavira (u obliku abakavirsulfata) u jednom ml otopine.
English: There are no differences observed between the AUC for the tablet or solution.
Croatian: Nisu uočene razlike između AUC-a tableta i AUC-a oralne otopine.
English: The abacavir + lamivudine once daily dosing group was demonstrated to be non-inferior to the twice daily group according to the pre-specified non-inferiority margin of -12%, for the primary endpoint of <80 c/ml at Week 48 as well as at Week 96 (secondary endpoint) and all other thresholds tested (<200c/ml, <400c/ml, <1000c/ml), which all fell well within this non-inferiority margin.
Croatian: Prema unaprijed određenoj granici neinferiornosti od -12%, pokazalo se da je skupina koja je primala abakavir + lamivudin jedanput na dan bila neinferiorna skupini koja je primala te lijekove dvaput na dan, s obzirom na primarnu mjeru ishoda od <80 kopija/ml u 48. tjednu, ali i u 96. tjednu (sekundarna mjera ishoda), kao i sve druge ispitivane granične vrijednosti (<200 kopija/ml, <400 kopija/ml, <1000 kopija/ml), koje su se sve nalazile značajno unutar spomenute granice neinferiornosti.
English: Induction of hepatic metabolism has not been observed in clinical studies.
Croatian: U kliničkim ispitivanjima nije zabilježena indukcija jetrenog metabolizma.
English: At therapeutic dosages a dosage of 300 mg twice daily, the mean (CV) steady state Cmax and Cmin of abacavir are approximately 3.00 µg/ml (30%) and 0.01 µg/ml(99%), respectively.
Croatian: Pri terapijskim dozama i doziranju od 300 mg dvaput na dan, srednja vrijednost Cmax abakavira u stanju dinamičke ravnoteže je otprilike 3 µg/ml (koeficijent varijacije 30%), a Cmin 0,01µg/ml (koeficijent varijacije 99%).
English: Do not store above 30°C
Croatian: POSEBNE MJERE ČUVANJA Ne čuvati na temperaturi iznad 30°C
English: None M184V alone 75 -0.74 Any one NRTI
Croatian: Bez mutacije Samo M184V 75
English: Number of Subjects Number of Virological Failures Number of On-Therapy Genotypes
Croatian: Broj ispitanika 282 Broj izostanaka virološkog odgovora
English: After a median follow-up of 144 weeks, 25% of subjects on the ZDV/3TC/ABC/EFV arm and 26% on the ZDV/3TC/EFV arm were categorised as having virological failure.
Croatian: Nakon medijana praćenja od 144 tjedna izostanak virološkog odgovora zabilježen je u 25% bolesnika koji su uzimali ZDV/3TC/ABC/EFV, te u 26% bolesnika koji su uzimali ZDV/3TC/EFV.
English: The other ingredients are sorbitol 70% (E420), saccharin sodium, sodium citrate, citric acid anhydrous, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), propylene glycol (E1520), maltodextrin, lactic acid, glyceryl triacetate, artificial strawberry and banana flavour, purified water, sodium hydroxide and/or hydrochloric acid for pH adjustment.
Croatian: Drugi sastojci su sorbitol 70% (E420), saharinnatrij, natrijev citrat, bezvodna citratna kiselina, metilparahidroksibenzoat (E218), propilparahidroksibenzoat (E216), propilenglikol (E1520),
English: If you get side effects
Croatian: Ako zadobijete nuspojave
English: Read the information ‘Other possible side effects of combination therapy for HIV' in Section 4 of this leaflet.
Croatian: Pozorno pročitajte informacije “Ostale moguće nuspojave u kombiniranoj terapiji za HIV”
English: Artificial strawberry and banana flavours Purified water
Croatian: maltodekstrin, laktatna kiselina, gliceroltriacetat, umjetna aroma jagode i banane, pročišćena voda,
English: Children less than three months of age: the experience in children aged less than three months is limited (see section 5.2).
Croatian: Djeca mlađa od 3 mjeseca: iskustvo u primjeni lijeka u djece mlađe od 3 mjeseca je ograničeno
English: Methylhydroxypropylcellulose Titanium dioxide Polysorbate 80
Croatian: Ovojnica triacetin metilhidroksipropilceluloza titanijev dioksid polisorbat 80 željezov oksid, žuti
English: In a meta-analysis of six clinical trials, TAMs were not selected by regimens containing abacavir without zidovudine (0/127), but were selected by regimens containing abacavir and the thymidine analogue zidovudine
Croatian: U metaanalizi 6 kliničkih ispitivanja, selekcije mutacija analoga timidina nisu utvrđene u režimima liječenja koji su uključivali abakavir bez zidovudina (0/127), ali jesu u režimima liječenja koji su uključivali abakavir i analog timidina zidovudin (22/86, 26%).
English: The recommended dose of Ziagen is 600 mg daily (30 ml).
Croatian: Uobičajena doza lijeka Ziagen je 600 mg (30 ml) na dan.
English: Use the oral dosing syringe supplied with the pack to measure your dose accurately.
Croatian: Za precizno određivanje doze, koristite štrcaljku za oralno doziranje koja je priložena u pakiranju.
English: The active substance in each Ziagen film-coated, scored tablet is 300 mg of abacavir (as sulfate).
Croatian: Djelatna tvar u jednoj Ziagen filmom obloženoj tableti s razdjelnom crtom je 300 mg abakavira (u obliku abakavirsulfata).
English: • Children weighing at least 14 kg and less than 20 kg: The usual dose of Ziagen is 300 mg a day.
Croatian: • Djeca tjelesne težine najmanje 14 kg, ali manje od 20 kg: Uobičajena doza lijeka Ziagen je
English: Ziagen 300 mg film-coated tablets Abacavir
Croatian: Ziagen 300 mg filmom obložene tablete abakavir
English: Ziagen should not be administered to patients with end-stage renal disease (see section 5.2).
Croatian: Ziagen ne treba davati bolesnicima s krajnjim stadijem bubrežne bolesti (vidjeti dio 5.2).
English: Do not store above 30°C Discard two months after first opening
Croatian: Baciti dva mjeseca nakon prvog otvaranja
English: Each ml of oral solution contains 20 mg of abacavir (as sulfate).
Croatian: Jedan ml oralne otopine sadrži 20 mg abakavira (u obliku abakavirsulfata).
English: Ziagen 300 mg film-coated tablets
Croatian: Ziagen 300 mg filmom obložene tablete
English: Teл.
Croatian: Ziagen.
English: This may be administered as either 300 mg (one tablet) twice daily or 600 mg (two tablets) once daily (see sections 4.4 and 5.1).
Croatian: Preporučena doza lijeka Ziagen je 600 mg na dan, primijenjeno kao 300 mg (jedna tableta) dvaput na dan ili 600 mg (dvije tablete) jedanput na dan (vidjeti dijelove 4.4 i 5.1).
English: In study ESS30008, 260 patients with virologic suppression on a first line therapy regimen containing abacavir 300 mg plus lamivudine 150 mg, both given twice daily and a PI or NNRTI, were randomised to continue this regimen or switch to abacavir/lamivudine FDC plus a PI or NNRTI for 48 weeks.
Croatian: U studiji ESS30008, 260 bolesnika u kojih je u prvoj liniji liječenja režimom abakavir u dozi od 300 mg dvaput na dan i lamivudin u dozi od 150 mg dvaput na dan uz inhibitor proteaze ili nenukleozidni inhibitor reverzne transkriptaze došlo do supresije virusa, randomizirano je tako da su 48 tjedana ili nastavili s tim režimom ili prešli na liječenje fiksnom kombinacijom abakavira i lamivudina uz inhibitor proteaze ili nenukleozidni inhibitor reverzne transkriptaze.
English: take Ziagen, or any other medicine containing abacavir (e.g. Trizivir, Triumeq or Kivexa).
Croatian: Ziagen ili bilo koji lijek koji sadržava abakavir (npr. Trizivir, Triumeq ili Kivexa).
English: Ziagen 20 mg/ml oral solution Abacavir
Croatian: Ziagen 20 mg/ml oralna otopina abakavir
English: This can be given as 150 mg (half of a tablet) twice daily, or 300 mg (one whole tablet) once a day as advised by your doctor.
Croatian: Može se primijeniti kao 150 mg (pola tablete) dvaput na dan ili kao 300 mg (jedna cijela tableta) jedanput na dan, sukladno savjetu liječnika.
English: - fever - shortness of breath, sore throat or cough - nausea or vomiting, diarrhoea or abdominal pain - severe tiredness or achiness, or generally feeling ill
Croatian: - mučnina ili povraćanje ili proljev ili bol u trbuhu - težak umor ili osjećaj boli u cijelom tijelu ili osjećaj opće slabosti
English: There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally to nucleoside analogues ; these have predominantly concerned treatment with regimens containing zidovudine.The main adverse reactions reported are haematological disorders (anaemia, neutropenia) and metabolic disorders (hyperlactatemia, hyperlipasemia).
Croatian: Postoje izvješća o poremećaju funkcije mitohondrija kod HIV-negativne dojenčadi koja je bila in utero i/ili postnatalno izložena analozima nukleozida; ova izvješća su se pretežno odnosila na liječenje režimima koji su sadržavali zidovudin.
English: 1.Combivir is a fixed dose combination of lamivudine and zidovudine 2.Includes three non-virological failures and four unconfirmed virological failures.
Croatian: Uključujući 3 neuspjeha nevirusnog karaktera i 4 nepotvrđena izostanka virološkog odgovora
English: Insert the syringe firmly into the adapter
Croatian: Stavite štrcaljku čvrsto u nastavak.
English: The demonstration of the benefit of Ziagen is mainly based on results of studies performed in treatment-naïve adult patients on combination therapy with a twice daily regimen (see section 5.1).
Croatian: Prikaz koristi lijeka Ziagen uglavnom se temelji na rezultatima studija provedenih u odraslih prethodno neliječenih bolesnika pri režimu doziranja dvaput na dan u kombinaciji s drugim lijekovima
English: Results indicate that the FDC group was associated with a similar virologic outcome (noninferior) compared to the abacavir plus lamivudine group, based on proportions of subjects with HIV1 RNA < 50 copies/ml (90% and 85% respectively, 95% CI -2.7, 13.5).
Croatian: Rezultati pokazuju da je u skupini koja je primala fiksnu kombinaciju virološki odgovor bio usporediv (jednako vrijedan) odgovoru u skupini koja je primala abakavir i lamivudin, na temelju udjela osoba s HIV-1 RNK < 50 kopija/ml (90%, odnosno 85%, 95% CI; -2,7; 13,5).
English: Microcrystalline cellulose Sodium starch glycollate Magnesium stearate Colloidal anhydrous silica
Croatian: Jezgra celuloza, mikrokristalična natrijev škroboglikolat magnezijev stearat silicijev dioksid, koloidni, bezvodni
English: This may be administered as either one 150 mg (one half of a tablet) taken in the morning and 300 mg (one whole tablet) taken in the evening, or 450 mg (one and a half tablets) taken once daily.
Croatian: Može se primijeniti kao 150 mg (pola tablete) ujutro i 300 mg (jedna cijela tableta) navečer ili kao 450 mg (jedna i pol tableta) jedanput na dan.
English: • Therapy naïve adults
Croatian: • Prethodno neliječeni odrasli bolesnici
English: How to store Ziagen
Croatian: Kako čuvati Ziagen
English: Citric acid anhydrous
Croatian: Hematološki simptomi limfopenija
English: Each film-coated tablet contains 300 mg abacavir (as sulfate).
Croatian: Jedna filmom obložena tableta sadrži 300 mg abakavira (u obliku abakavirsulfata).
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
Croatian: U slučaju da bolesnik istodobno prima neki antivirusni lijek za liječenje hepatitisa B ili C,
English: Results indicate that the FDC group was non-inferior to the abacavir twice daily group, based on similar reductions in HIV-1 RNA as measured by average area under the curve minus baseline (AAUCMB, -1.65 log10 copies/ml versus -1.83 log10 copies/ml respectively, 95% CI -0.13, 0.38).
Croatian: određenom prema prosječnoj površini pod krivuljom umanjenoj za početne vrijednosti, pokazuju da je skupina koja je primala fiksnu kombinaciju jednako vrijedna kao skupina koja je primala abakavir dvaput na dan (AAUCMB; -1,65 log10 kopija/ml naspram -1,83 log10 kopija/ml, 95% CI; -0,13; 0,38).
English: • Children weighing at least 20 kg and less than 25 kg: The usual dose of Ziagen is 450 mg a day.
Croatian: • Djeca tjelesne težine najmanje 20 kg, ali manje od 25 kg: Uobičajena doza lijeka Ziagen je
English: ACTG5095 was a randomised (1:1:1), double-blind, placebo-controlled trial performed in 1147 antiretroviral naïve HIV-1 infected adults, comparing 3 regimens: zidovudine (ZDV), lamivudine (3TC), abacavir (ABC), efavirenz (EFV) vs ZDV/3TC/EFV vs ZDV/3TC/ABC.
Croatian: ACTG5095 je bilo randomizirano (1:1:1), dvostruko slijepo, placebom kontrolirano ispitivanje, provedeno na 1147 bolesnika zaraženih virusom HIV-1, koji još nisu bili liječeni antiretrovirusnim lijekovima.
English: - fever - shortness of breath, sore throat or cough - nausea or vomiting or diarrhoea or abdominal pain - severe tiredness or achiness or generally feeling ill If you have discontinued Ziagen due to this reaction, YOU MUST NEVER TAKE Ziagen or any other abacavir containing medicine (e.g. Kivexa, Trizivir or Triumeq) again, as within hours you may experience a life-threatening lowering of your blood pressure or death.
Croatian: Ako ste zbog takve reakcije prestali uzimati Ziagen, VIŠE NIKADA ne smijete uzimati Ziagen niti druge lijekove koji sadrže abakavir (npr. Kivexa, Trizivir ili Triumeq), jer se unutar nekoliko sati možete razviti po život opasno sniženje krvnog tlaka ili smrt.
English: Methyl parahydroxybenzoate (E218) 1.5 mg/ml Propyl parahydroxybenzoate (E216) 0.18 mg/ml For the full list of excipients see section 6.1.
Croatian: sorbitol (E420) 340 mg/ml metilparahidroksibenzoat (E218) 1,5 mg/ml propilparahidroksibenzoat (E216) 0,18 mg/ml
English: Ziagen should be prescribed by physicians experienced in the management of HIV infection.
Croatian: 4.2 Doziranje i način primjene Ziagen treba propisivati liječnik koji ima iskustva u liječenju HIV infekcije.
English: Triple nucleoside therapy
Croatian: Liječenje kombinacijom tri nukleozida
English: This may be administered as either 300 mg (15 ml) twice daily or 600 mg (30 ml) once daily (see sections 4.4 and 5.1).
Croatian: Preporučena doza lijeka Ziagen je 600 mg (30 ml) na dan, primijenjeno kao 300 mg (15 ml) dvaput na dan ili 600 mg (30 ml) jedanput na dan (vidjeti dijelove 4.4 i 5.1).
English: In the intent-to-treat (ITT) population, 70% of patients in the abacavir group, compared to 69% of patients in the zidovudine group, achieved a virologic response of plasma HIV-1 RNA ≤50 copies/ml by Week 48 (point estimate for treatment difference: 0.8, 95% CI -6.3, 7.9).
Croatian: U populaciji s namjerom liječenja, 70% bolesnika, koji su uzimali abakavir te 69% bolesnika, koji su uzimali zidovudin postigli su virološki odgovor s plazmatskom koncentracijom HIV-1 RNA ≤50 kopija/ml u 48. tjednu
English: Gastrointestinal disorders Common: nausea, vomiting, diarrhoea Rare: pancreatitis
Croatian: Poremećaji probavnog sustava Često: mučnina, povraćanje, proljev
English: This may be administered as either 150 mg (one half of a tablet) twice daily or 300 mg (one whole tablet) once daily.
Croatian: Može se primijeniti kao 150 mg (pola tablete) dvaput na dan ili kao 300 mg (jedna cijela tableta) jedanput na dan.
English: Many of the adverse reactions listed below occur commonly (nausea, vomiting, diarrhoea, fever, lethargy, rash) in patients with abacavir hypersensitivity.
Croatian: Mnoge od nuspojava navedenih u nastavku javljaju se često (mučnina, povraćanje, proljev, vrućica,
English: Ziagen 20 mg/ml oral solution
Croatian: Ziagen 20 mg/ml oralna otopina