natgillin/translations-raw huggingface dataset:
Ethanol: the metabolism of abacavir is altered by concomitant ethanol resulting in an increase in AUC of abacavir of about 41%.
Etanol: Metabolizam abakavira se mijenja istovremenim uzimanjem etanola, što dovodi do povećanja
Abacavir is primarily metabolised by the liver with approximately 2% of abacavir excreted unchanged in the urine.
Abakavir se primarno metabolizira putem jetre, a približno 2% abakavira se izlučuje urinom u nepromijenjenom obliku.
The oral solution is clear to slightly opalescent yellowish, aqueous solution which may turn into a brown colour over time
Oralna otopina Oralna otopina je bistra do lagano opalescentno žućkasta vodena otopina koja s vremenom može postati smeđe boje.
IMPORTANT - Hypersensitivity reactions
VAŽNO- Reakcije preosjetljivosti
• 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.
• 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).
Therefore no dosage reduction is required in patients with renal impairment.
Stoga nije potrebno smanjenje doze u bolesnika s oštećenjem funkcije bubrega.
• lactic acidosis (excess lactic acid in the blood)
30% površine tijela (toksična epidermalna nekroliza) • laktacidoza (nakupljanje mliječne kiseline u krvi)
Nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage.
Pokazalo se da analozi nukleozida i nukleotida uzrokuju različite stupnjeve mitohondrijskog oštećenja in vitro i in vivo.
If a twice daily regimen is not feasible, a once daily regimen (16 mg/kg/day) could be considered.
Ako režim primjene dvaput na dan nije moguće provesti, može se razmotriti režim primjene jedanput na dan
This can be taken either as one 300 mg tablet twice a day or two 300 mg tablets once a day.
Ona se može uzeti kao jedna tableta od 300 mg dvaput na dan ili kao dvije tablete od 300 mg jedanput na dan.
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.
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.
The active substance in Ziagen oral solution is 20 mg of abacavir (as sulfate) in each ml of the solution.
Djelatna tvar u Ziagen oralnoj otopini je 20 mg abakavira (u obliku abakavirsulfata) u jednom ml otopine.
There are no differences observed between the AUC for the tablet or solution.
Nisu uočene razlike između AUC-a tableta i AUC-a oralne otopine.
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.
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.
Induction of hepatic metabolism has not been observed in clinical studies.
U kliničkim ispitivanjima nije zabilježena indukcija jetrenog metabolizma.
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.
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%).
Do not store above 30°C
POSEBNE MJERE ČUVANJA Ne čuvati na temperaturi iznad 30°C
None M184V alone 75 -0.74 Any one NRTI
Bez mutacije Samo M184V 75
Number of Subjects Number of Virological Failures Number of On-Therapy Genotypes
Broj ispitanika 282 Broj izostanaka virološkog odgovora
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.
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.
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.
Drugi sastojci su sorbitol 70% (E420), saharinnatrij, natrijev citrat, bezvodna citratna kiselina, metilparahidroksibenzoat (E218), propilparahidroksibenzoat (E216), propilenglikol (E1520),
If you get side effects
Ako zadobijete nuspojave
Read the information ‘Other possible side effects of combination therapy for HIV' in Section 4 of this leaflet.
Pozorno pročitajte informacije “Ostale moguće nuspojave u kombiniranoj terapiji za HIV”
Artificial strawberry and banana flavours Purified water
maltodekstrin, laktatna kiselina, gliceroltriacetat, umjetna aroma jagode i banane, pročišćena voda,
Children less than three months of age: the experience in children aged less than three months is limited (see section 5.2).
Djeca mlađa od 3 mjeseca: iskustvo u primjeni lijeka u djece mlađe od 3 mjeseca je ograničeno
Methylhydroxypropylcellulose Titanium dioxide Polysorbate 80
Ovojnica triacetin metilhidroksipropilceluloza titanijev dioksid polisorbat 80 željezov oksid, žuti
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
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%).
The recommended dose of Ziagen is 600 mg daily (30 ml).
Uobičajena doza lijeka Ziagen je 600 mg (30 ml) na dan.
Use the oral dosing syringe supplied with the pack to measure your dose accurately.
Za precizno određivanje doze, koristite štrcaljku za oralno doziranje koja je priložena u pakiranju.
The active substance in each Ziagen film-coated, scored tablet is 300 mg of abacavir (as sulfate).
Djelatna tvar u jednoj Ziagen filmom obloženoj tableti s razdjelnom crtom je 300 mg abakavira (u obliku abakavirsulfata).
• Children weighing at least 14 kg and less than 20 kg: The usual dose of Ziagen is 300 mg a day.
• Djeca tjelesne težine najmanje 14 kg, ali manje od 20 kg: Uobičajena doza lijeka Ziagen je
Ziagen 300 mg film-coated tablets Abacavir
Ziagen 300 mg filmom obložene tablete abakavir
Ziagen should not be administered to patients with end-stage renal disease (see section 5.2).
Ziagen ne treba davati bolesnicima s krajnjim stadijem bubrežne bolesti (vidjeti dio 5.2).
Do not store above 30°C Discard two months after first opening
Baciti dva mjeseca nakon prvog otvaranja
Each ml of oral solution contains 20 mg of abacavir (as sulfate).
Jedan ml oralne otopine sadrži 20 mg abakavira (u obliku abakavirsulfata).
Ziagen 300 mg film-coated tablets
Ziagen 300 mg filmom obložene tablete
Teл.
Ziagen.
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).
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).
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.
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.
take Ziagen, or any other medicine containing abacavir (e.g. Trizivir, Triumeq or Kivexa).
Ziagen ili bilo koji lijek koji sadržava abakavir (npr. Trizivir, Triumeq ili Kivexa).
Ziagen 20 mg/ml oral solution Abacavir
Ziagen 20 mg/ml oralna otopina abakavir
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.
Može se primijeniti kao 150 mg (pola tablete) dvaput na dan ili kao 300 mg (jedna cijela tableta) jedanput na dan, sukladno savjetu liječnika.
- fever - shortness of breath, sore throat or cough - nausea or vomiting, diarrhoea or abdominal pain - severe tiredness or achiness, or generally feeling ill
- mučnina ili povraćanje ili proljev ili bol u trbuhu - težak umor ili osjećaj boli u cijelom tijelu ili osjećaj opće slabosti
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).
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.
1.Combivir is a fixed dose combination of lamivudine and zidovudine 2.Includes three non-virological failures and four unconfirmed virological failures.
Uključujući 3 neuspjeha nevirusnog karaktera i 4 nepotvrđena izostanka virološkog odgovora
Insert the syringe firmly into the adapter
Stavite štrcaljku čvrsto u nastavak.
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).
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
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).
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).
Microcrystalline cellulose Sodium starch glycollate Magnesium stearate Colloidal anhydrous silica
Jezgra celuloza, mikrokristalična natrijev škroboglikolat magnezijev stearat silicijev dioksid, koloidni, bezvodni
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.
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.
• Therapy naïve adults
• Prethodno neliječeni odrasli bolesnici
How to store Ziagen
Kako čuvati Ziagen
Citric acid anhydrous
Hematološki simptomi limfopenija
Each film-coated tablet contains 300 mg abacavir (as sulfate).
Jedna filmom obložena tableta sadrži 300 mg abakavira (u obliku abakavirsulfata).
In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
U slučaju da bolesnik istodobno prima neki antivirusni lijek za liječenje hepatitisa B ili C,
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).
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).
• Children weighing at least 20 kg and less than 25 kg: The usual dose of Ziagen is 450 mg a day.
• Djeca tjelesne težine najmanje 20 kg, ali manje od 25 kg: Uobičajena doza lijeka Ziagen je
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.
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.
- 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.
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.
Methyl parahydroxybenzoate (E218) 1.5 mg/ml Propyl parahydroxybenzoate (E216) 0.18 mg/ml For the full list of excipients see section 6.1.
sorbitol (E420) 340 mg/ml metilparahidroksibenzoat (E218) 1,5 mg/ml propilparahidroksibenzoat (E216) 0,18 mg/ml
Ziagen should be prescribed by physicians experienced in the management of HIV infection.
4.2 Doziranje i način primjene Ziagen treba propisivati liječnik koji ima iskustva u liječenju HIV infekcije.
Triple nucleoside therapy
Liječenje kombinacijom tri nukleozida
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).
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).
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).
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
Gastrointestinal disorders Common: nausea, vomiting, diarrhoea Rare: pancreatitis
Poremećaji probavnog sustava Često: mučnina, povraćanje, proljev
This may be administered as either 150 mg (one half of a tablet) twice daily or 300 mg (one whole tablet) once daily.
Može se primijeniti kao 150 mg (pola tablete) dvaput na dan ili kao 300 mg (jedna cijela tableta) jedanput na dan.
Many of the adverse reactions listed below occur commonly (nausea, vomiting, diarrhoea, fever, lethargy, rash) in patients with abacavir hypersensitivity.
Mnoge od nuspojava navedenih u nastavku javljaju se često (mučnina, povraćanje, proljev, vrućica,
Ziagen 20 mg/ml oral solution
Ziagen 20 mg/ml oralna otopina
Although a similar antiviral effect was observed between the abacavir and indinavir containing regimens in terms of proportion of patients with undetectable viral load (≤400 copies/ml; intention to treat analysis (ITT), 47% versus 49%; as treated analysis (AT), 86% versus 94% for abacavir and indinavir combinations respectively), results favoured the indinavir combination, particularly in the subset of patients with high viral load (>100,000 copies/ml at baseline; ITT, 46% versus 55%; AT, 84% versus 93% for abacavir and indinavir respectively).
za kombinacije s indinavirom u analizi bolesnika s namjerom liječenja (ITT, engl. intention to treat); 86% za kombinacije s abakavirom naspram 94% za kombinacije s indinavirom u analizi liječenih bolesnika (AT, engl. as treated)), rezultati su pokazali da je kombinacija s indinavirom učinkovitija, osobito u podskupini bolesnika s visokim virusnim opterećenjem (>100 000 kopija/ml na početku;
Mild myocardial degeneration in the heart of mice and rats was observed following administration of abacavir for two years.
Nakon dvogodišnje primjene abakavira, primijećena je blaga degeneracija miokarda u miševa i štakora.
These were primarily asymptomatic HIV infected patients - Centre for Disease Control and Prevention (CDC) stage A. They were randomised to receive either abacavir 600 mg once daily or 300 mg twice daily, in combination with efavirenz and lamivudine given once daily.
Oni su bili randomizirani u dvije skupine koje su primale ili abakavir (600 mg jedanput na dan ili abakavir 300 mg dvaput na dan, u kombinaciji s efavirenzom i lamivudinom jedanput na dan.
These may affect up to 1 in 1,000 people: • inflammation of the pancreas (pancreatitis)
Mogu se pojaviti u manje od 1 na 10 osoba: • reakcija preosjetljivosti
However, Ziagen is not recommended for patients with end-stage renal disease (see section 5.2).
Međutim, treba izbjegavati primjenu lijeka Ziagen u bolesnika s krajnjim stadijem bubrežne bolesti (vidjeti dio 5.2).
(e.g. Triumeq,Trizivir or Kivexa).
Trizivir, Triumeq ili Kivexa).
After a median follow-up of 32 weeks, the tritherapy with the three nucleosides ZDV/3TC/ABC was shown to be virologically inferior to the two other arms regardless of baseline viral load (< or > 100 000 copies/ml) with 26% of subjects on the ZDV/3TC/ABC arm, 16% on the ZDV/3TC/EFV arm and 13% on the 4 drug arm categorised as having virological failure (HIV RNA >200 copies/ml).
32 tjedna pokazalo se da je liječenje s tri nukleozida ZDV/3TC/ABC virološki manje uspješno nego liječenje u druge dvije skupine, bez obzira na početno virusno opterećenje (< ili > 100 000 kopija/ml).
Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG 12 0DJ, United Kingdom.
Glaxo Operations UK Ltd, (posluje kao Glaxo Wellcome Operations), Harmire Road, Barnard Castle, Co.
• feeling sick (nausea)
• upala gušterače (pankreatitis)
There have been reports of a high rate of virological failure and of emergence of resistance at an early stage when abacavir was combined with tenofovir disoproxil fumarate and lamivudine as a once daily regimen.
Pri kombiniranoj primjeni abakavira s tenofovir dizoproksilfumaratom i lamivudinom jedanput na dan zabilježen je visok postotak izostanka virološkog odgovora te nastup rezistencije u ranoj fazi liječenja.
Single doses up to 1200 mg and daily doses up to 1800 mg of Ziagen have been administered to patients in clinical studies.
Bolesnicima u kliničkim ispitivanjima primijenjene su pojedinačne doze do 1200 mg i dnevne doze do
Manufacturer: Glaxo Operations UK Ltd, (trading as GlaxoWellcome Operations) Harmire Road Barnard Castle Co. Durham DL12 8DT United Kingdom or ViiV Healthcare Trading Services UK Limited, 12 Riverwalk,
Durham DL12 8DT, Ujedinjeno Kraljevstvo ili ViiV Healthcare Trading Services UK Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Irska Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet:
Saccharin sodium
Oralna otopina
Tell your doctor or pharmacist if any of the side effects get severe or troublesome, or if you notice any side effects not listed in this leaflet.
Ako bilo koja od navedenih nuspojava postane teška ili zabrinjavajuća ili ako primijetite bilo koju nuspojavu koja nije navedena u ovoj Uputi, potrebno je obavijestiti liječnika ili ljekarnika.
2 to 12 years (N=14) PENTA 15 3 to 36 months (N=18)
3-36 mjeseci (N=18)
In study CAL30001, 182 treatment-experienced patients with virologic failure were randomised and received treatment with either the fixed-dose combination of abacavir/lamivudine (FDC) once daily or abacavir 300 mg twice daily plus lamivudine 300 mg once daily, both in combination with tenofovir and a PI or an NNRTI for 48 weeks.
randomizirani su tako da su tijekom 48 tjedana dobivali ili fiksnu kombinaciju abakavira i lamivudina jedanput na dan ili abakavir u dozi od 300 mg dvaput na dan uz lamivudin 300 mg jedanput na dan, u oba slučaja u kombinaciji s tenofovirom i nekim inhibitorom proteaze ili nekim nenukleozidnim inhibitorom reverzne transkriptaze.
Ziagen 300 mg tablets.
Ziagen 300 mg tablete abakavir
Musculoskeletal
Bolest bubrega
Ziagen contains abacavir (which is also an active substance in Trizivir , Triumeq and Kivexa).
Ziagen sadržava abakavir (koji je isto djelatna tvar u lijekovima Trizivir, Triumeq i Kivexa).
INSTRUCTIONS ON USE 16.
u dijelu 4 ove upute.
A randomised comparison of a regimen including once daily vs twice daily dosing of abacavir and lamivudine was undertaken within a randomised, multicentre, controlled study of HIV-infected, paediatric patients.
U sklopu randomiziranog, multicentričnog, kontroliranog ispitivanja s pedijatrijskim bolesnicima zaraženima HIV-om provedena je randomizirana usporedba režima primjene abakavira i lamivudina jedanput na dan u odnosu na režim primjene dvaput na dan.
Remove the bottle cap. Keep it safely.
Izvadite štrcaljku iz boce i operite je u čistoj vodi.
GlaxoSmithKline Kft. Tel.: + 36 1 225 5300
GlaxoSmithKline d.o.o. Tel:++385 1 6051 999
Ziagen contains abacavir (which is also an active substance in medicines such as Kivexa, Triumeq and Trizivir).
Ziagen sadrži abakavir (koji je također djelatna tvar u lijekovima kao što su Kivexa, Triumeq i
Ziagen contains abacavir (which is also an active substance in medicines such as Kivexa,Triumeq and Trizivir).
Ziagen sadrži abakavir(koji je također djelatna tvar u lijekovima kao što su Kivexa, Triumeq i
• if you have severe kidney disease Talk to your doctor if any of these apply to you.
Obavijestite liječnika ako se išta od navedenog odnosi na Vas.
Clinical description of abacavir HSR
Klinički opis reakcije preosjetljivosti na abakavir
Tablet Coating
Česte nuspojave
• Ziagen should never be initiated in patients with a positive HLA-B*5701 status, nor in patients with a negative HLA-B*5701 status who had a suspected abacavir HSR on a previous abacavir-containing regimen.
• Liječenje lijekom Ziagen ne smije se nikada započeti u bolesnika s pozitivnim HLA-B*5701
Once-Versus Twice-Daily Comparison GLS Mean Ratio (90% Cl)
Usporedba primjene jedanput naspram dvaput na dan -omjer geometrijskih srednjih vrijednosti dobivenih metodom najmanjih kvadrata (90% Cl)
Description of Selected Adverse Reactions
Opis odabranih nuspojava Reakcije preosjetljivosti na abakavir
Age Group
Starije osobe