natgillin/translations-raw huggingface dataset:
Hos 26% af patienterne, der fik ZDV/ 3TC/ ABC- kombinationen var der manglende virologisk effekt (HIV RNA > 200 kopier/ ml), mens det tilsvarende var 16% for ZDV/ 3TC/ EFV og 13% for 4- stofkombinationen.
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).
Ved en middelvurdering efter 144 uger blev 25% af patienterne i behandling med ZDV/ 3TC/ ABC/ EFV og 26% af patienterne i behandling med ZDV/ 3TC/ EFV kategoriseret, som havende virologisk svigt.
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.
Der var ingen signifikant forskel i tiden indtil første virologiske svigt (p = 0, 73; log - rank test) mellem de to arme.
There was no significant difference in the time to first virologic failure (p=0.73, log-rank test) between the 2 arms.
Terapinaive børn
13 • Therapy naïve children
I en undersøgelse, der sammenlignede ublindede NRTI- kombinationer (med eller uden blindet nelfinavir) hos børn, havde en større andel, behandlet med abacavir og lamivudin (71%) eller abacavir og zidovudin (60%), HIV- 1 RNA ≤ 400 kopier/ ml ved 48 uger, sammenlignet med dem, der blev behandlet med lamivudin og zidovudin (47%) [p = 0, 09, ” intention to treat ” - analyse].
In a study comparing the unblinded NRTI combinations (with or without blinded nelfinavir) in children, a greater proportion treated with abacavir and lamivudine (71%) or abacavir and zidovudine (60%) had HIV-1 RNA ≤ 400 copies/ ml at 48 weeks, compared with those treated with lamivudine and zidovudine (47%)[ p=0.09, intention to treat analysis].
Ligeledes havde en større andel af børn i behandling med kombinationer indeholdende abacavir HIV- 1 RNA ≤ 50 kopier/ ml ved 48 uger (henholdsvis 53%, 42% og 28%, p = 0, 07).
Similarly, greater proportions of children treated with the abacavir containing combinations had HIV-1 RNA ≤ 50 copies/ ml at 48 weeks (53%, 42% and 28% respectively, p=0.07).
13 • Tidligere behandlede patienter
• Therapy experienced patients
Hos voksne som tidligere havde modtaget begrænset antiretroviral behandling, havde tillæg af abacavir til kombineret antiretroviral behandling begrænset værdi i reduktion af virusbyrden (median for ændring 0, 44 log10 kopier/ ml efter 16 uger).
In adults moderately exposed to antiretroviral therapy the addition of abacavir to combination antiretroviral therapy provided modest benefits in reducing viral load (median change 0.44 log10 copies/ ml at 16 weeks).
Hvor stor fordelen er som del af et nyt kombinationsregime vil afhænge af arten og varigheden af forudgående behandling, som eventuelt har selekteret for HIV- 1- varianter med krydsresistens over for abacavir.
The degree of benefit as part of a new combination regimen will depend on the nature and duration of prior therapy which may have selected for HIV-1 variants with cross-resistance to abacavir.
Én gang daglig regimet med abacavir støttes af et 48 ugers multi- center, dobbelblindt, kontrolleret studie (CNA30021) af 770 HIV- inficerede, terapinaive voksne.
The once daily regimen of abacavir is supported by a 48 weeks multi-centre, double-blind, controlled study (CNA30021) of 770 HIV-infected, therapy-naïve adults.
De blev randomiseret til at modtage enten abacavir 600 mg én gang daglig eller 300 mg to gange daglig, i kombination med efavirenz og lamivudin givet én gang daglig.
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.
Ensartet klinisk succes (point estimate for behandlingsforskel - 1. 7, 95% CI - 8. 4, 4. 9) blev observeret for begge regimer.
Similar clinical success (point estimate for treatment difference -1.7, 95% CI -8.4, 4.9) was observed for both regimens.
Der var en lav, ensartet overordnet forekomst af virologisk svigt (viral load > 50 kopier/ ml) både i én gang daglig og to gange daglig behandlingsgrupperne (henholdsvis 10% og 8%).
There was a low, similar overall incidence of virologic failure (viral load > 50 copies/ ml) in both the once and twice daily treatment groups (10% and 8% respectively).
I den lille sample størrelse for genotypeanalyse, var der en tendens mod en højere hyppighed af NRTI- associerede mutationer i én gang daglig versus to gange daglig abacavir regimet.
In the small sample size for genotypic analysis, there was a trend toward a higher rate of NRTI-associated mutations in the once daily versus the twice daily abacavir regimens.
Ingen fast konklusion kunne drages ud fra de begrænsede data fra dette forsøg.
No firm conclusion could be drawn due to the limited data derived from this study.
• Tidligere behandlede patienter
• Therapy experienced patients
I studie CAL30001, blev 182 tidligere behandlede patienter med virologisk svigt randomiseret og de modtog enten fastdosiskombinationen (FDC) af abacavir/ lamivudin én gang daglig, eller abacavir 300 mg to gange daglig plus lamivudin 300 mg én gang daglig, begge i kombination med tenofovir og en PI eller en NNRTI i 48 uger.
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.
Resultater indikerer at FDC- gruppen var ikke- inferiør over for gruppen med abacavir to gange daglig baseret på ensartede reduktioner i HIV- 1 RNA målt som det gennemsnitlige areal under kurven minus baseline (AAUCMB, henholdsvis - 1. 65 log10 kopier/ ml versus - 1. 83 log10 kopier/ ml, 95% CI - 0. 13, 0. 38).
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).
Forholdene mellem HIV- 1 < 50 kopier/ ml (50% versus 47%) og < 400 kopier/ ml (54% versus 57%) var ligeledes ensartet i hver gruppe (ITT population).
Proportions with HIV-1 RNA < 50 copies/ ml (50% versus 47%) and < 400 copies/ ml (54% versus 57%) were also similar in each group (ITT population).
I studie, ESS30008, blev 260 patienter med virologisk suppression på et ” first line ” terapi regime bestående af abacavir 300 mg plus lamivudin 150 mg begge givet to gange daglig og en PI eller NNRTI, randomiseret til at fortsætte dette regime eller at skifte til abacavir/ lamivudin FDC plus en PI eller NNRTI i 48 uger.
Results indicate that the FDC group was associated with a similar virologic outcome (non-
Resultaterne indikerer at FDC- gruppen kunne associeres med et ensartet virologisk udfald (ikke- inferiørt) sammenlignet med abacavir plus lamivudingruppen baseret på forholdet mellem individer med HIV- 1 RNA < 50 kopier/ ml (henholdsvis 90% og 85%, 95% CI - 2. 7, 13. 5).
14 inferior) compared to the abacavir plus lamivudine group, based on proportions of subjects with HIV- 1 RNA < 50 copies/ ml (90% and 85% respectively, 95% CI -2.7, 13.5).
• Yderligere oplysninger:
Additional information:
Sikkerheden og effekten af Ziagen i et antal forskellige multistof kombinationsregimer er stadig ikke fuldstændigt vurderet (specielt i kombination med NNRTI’ er).
The safety and efficacy of Ziagen in a number of different multidrug combination regimens is still not completely assessed (particularly in combination with NNRTIs).
14 Abacavir penetrerer cerebrospinalvæsken (CSF) (se afsnit 5. 2) og nedsætter påviseligt mængden af HIV- 1 RNA i CSF.
Abacavir penetrates the cerebrospinal fluid (CSF) (see section 5.2), and has been shown to reduce HIV-1 RNA levels in the CSF.
Der er dog ikke set nogen effekt på den neuropsykologiske tilstand ved administration af stoffet til patienter med AIDS demens kompleks.
However, no effects on neuropsychological performance were seen when it was administered to patients with AIDS dementia complex.
Abacavir absorberes hurtigt og godt efter peroral administration.
Absorption: abacavir is rapidly and well absorbed following oral administration.
83%.
The absolute bioavailability of oral abacavir in adults is about 83%.
1, 0 time for den orale opløsning.
Following oral administration, the mean time (tmax) to maximal serum concentrations of abacavir is about 1.5 hours for the tablet formulation and about 1.0 hour for the solution formulation.
Ved terapeutiske doser, en dosis på 300 mg to gange daglig, er den gennemsnitlige (CV) steady state Cmax og Cmin for abacavir cirka 3, 00 μg/ ml (30%) henholdsvis 0, 01 μg/ ml (99%).
At therapeutic dosages a dosage of 300 mg twice daily, the mean (CV) steady state Cmax and Cmin of abacavir are approximately 3.00 μ g/ ml (30%) and 0.01 µg/ ml (99%), respectively.
12, 0 μg. h/ ml.
The mean (CV) AUC over a dosing interval of 12 hours was 6.02 μ g. h/ ml (29%), equivalent to a daily AUC of approximately 12.0 μ g. h/ ml.
4, 26 μg/ ml (28%) og den gennemsnitlige (CV) AUC∞ var 11, 95 μg. h/ ml (21%).
After a 600 mg abacavir tablet dose, the mean (CV) abacavir Cmax was approximately 4.26 μ g/ ml (28%) and the mean (CV) AUC ∞ was 11.95 μ g. h/ ml (21%).
0, 8 l/ kg, hvilket tyder på, at abacavir nemt trænger ud i kropsvæv.
Distribution: following intravenous administration, the apparent volume of distribution was about 0.8 l/ kg, indicating that abacavir penetrates freely into body tissues.
Undersøgelser hos HIV- inficerede patienter har vist god penetration af abacavir til cerebrospinalvæsken (CSF) med et fordelingsforhold mellem CSF og plasma AUC på mellem 30 og 44%.
Studies in HIV infected patients have shown good penetration of abacavir into the cerebrospinal fluid (CSF), with a CSF to plasma AUC ratio of between 30 to 44%.
In vitro- undersøgelser for plasmaproteinbinding indikerer, at abacavir kun i begrænset til moderat omfang (~49%) bindes til humane plasmaproteiner ved terapeutiske koncentrationer.
Plasma protein binding studies in vitro indicate that abacavir binds only low to moderately (~49%) to human plasma proteins at therapeutic concentrations.
2% af den indgivne dosis udskilles uomdannet via nyrerne.
Metabolism: abacavir is primarily metabolised by the liver with approximately 2% of the administered dose being renally excreted, as unchanged compound.
66% af den administrerede dosis.
The primary pathways of metabolism in man are by alcohol dehydrogenase and by glucuronidation to produce the 5’ -carboxylic acid and 5’ - glucuronide which account for about 66% of the administered dose.
Den gennemsnitlige halveringstid af abacavir er ca.
Elimination: the mean half-life of abacavir is about 1.5 hours.
Intracellulære farmakokinetikker
15 Intracellular pharmacokinetics
I en undersøgelse af 20 HIV- inficerede patienter der fik abacavir 300 mg to gange daglig, med kun én 300 mg dosis indtaget før prøveudtagning efter 24 timer, var den geometriske gennemsnitlige terminale carbovir- TP intracellulære halveringstid ved steady state 20, 6 timer, sammenlignet med den geometriske gennemsnitlige abacavir plasma halveringstid i dette studie på 2, 6 timer.
In a study of 20 HIV-infected patients receiving abacavir 300 mg twice daily, with only one 300 mg dose taken prior to the 24 hour sampling period, the geometric mean terminal carbovir-TP intracellular half-life at steady-state was 20.6 hours, compared to the geometric mean abacavir plasma half-life in this study of 2.6 hours.
15 ved behandling med 600 mg abacavir én gang daglig (AUC24, ss + 32%, Cmax24, ss + 99% og Ctrough + 18%) sammenlignet med behandling med 300 mg to gange daglig.
In a crossover study in 27 HIV-infected patients, intracellular carbovir-TP exposures were higher for the abacavir 600 mg once daily regimen (AUC24, ss + 32%, Cmax24, ss + 99% and Ctrough + 18%) compared to the 300 mg twice daily regimen.
Disse data støtter brugen af abacavir 600 mg én gang daglig til behandling af HIV- inficerede patienter.
Overall, these data support the use of abacavir 600 mg once daily for the treatment of HIV infected patients.
Derudover er effekten og sikkerheden af abacavir, givet én gang daglig, blevet demonstreret i et pivotalt klinisk forsøg (CNA - 30021 - se afsnit 5. 1 Klinisk erfaring).
Additionally, the efficacy and safety of abacavir given once daily has been demonstrated in a pivotal clinical study (CNA30021- See section 5.1 Clinical experience).
Abacavir metaboliseres primært i leveren.
Hepatically impaired: abacavir is metabolised primarily by the liver.
Dosisreduktion til patienter med let nedsat leverfunktion kan ikke anbefales på grund af betydelig variation i eksponeringen af abacavir.
No recommendation on dosage reduction is possible in patients with mild hepatic impairment due to the substantial variability of abacavir exposure.
2% abacavir udskilles uomdannet i urinen.
Renally impaired: abacavir is primarily metabolised by the liver with approximately 2% of abacavir excreted unchanged in the urine.
Ifølge kliniske undersøgelser med børn absorberes abacavir hurtigt og godt, når det gives som oral opløsning.
Children: according to clinical trials performed in children abacavir is rapidly and well absorbed from an oral solution administered to children.
De samlede farmakokinetiske parametre hos børn er sammenlignelige med dem hos voksne, men med større variation i plasmakoncentrationerne.
The overall pharmacokinetic parameters in children are comparable to adults, with greater variability in plasma concentrations.
Den anbefalede dosis til børn fra tre måneder til 12 år er 8 mg/ kg to gange daglig.
The recommended dose for children from three months to 12 years is 8 mg/ kg twice daily.
Dette vil resultere i lidt højere middelplasmakoncentrationer hos børn, hvilket betyder, at størstedelen vil opnå terapeutiske koncentrationer svarende til 300 mg to gange daglig for voksne.
This will provide slightly higher mean plasma concentrations in children, ensuring that the majority will achieve therapeutic concentrations equivalent to 300 mg twice daily in adults.
De begrænsede tilgængelige data indikerer, at en dosis på 2 mg/ kg til nyfødte, der er under 30 dage gamle, giver lignende eller større AUC’ er, sammenlignet med en dosis på 8 mg/ kg givet til ældre børn.
The limited data available indicate that a dose of 2 mg/ kg in neonates less than 30 days old provides similar or greater AUCs, compared to the 8 mg/ kg dose administered to older children.
Farmakokinetikken af abacavir er ikke undersøgt hos patienter over 65 år.
Elderly: the pharmacokinetics of abacavir have not been studied in patients over 65 years of age.
Abacavir var ikke mutagent i bakterietests, men viste aktivitet in vitro i kromosomafvigelsesprøven med humane lymfocytter, muselymfomcelletesten og i in vivo mikronukleusundersøgelsen.
Abacavir was not mutagenic in bacterial tests but showed activity in vitro in the human lymphocyte chromosome aberration assay, the mouse lymphoma assay, and the in vivo micronucleus test.
Carcinogenicitetsundersøgelser hos mus og rotter af oralt administreret abacavir viste en stigning i forekomsten af ond - og godartede tumorer.
Carcinogenicity studies with orally administered abacavir in mice and rats showed an increase in the incidence of malignant and non-malignant tumours.
Den systemiske eksponering hvor der ikke var nogen effekt hos mus og rotter, svarede til 3 og 7 gange den systemiske eksponering hos mennesker under behandling.
The systemic exposure at the no effect level in mice and rats was equivalent to 3
Mens det carcinogene potentiale hos mennesker er ukendt, indikerer disse data, at den carcinogene risiko hos mennesker opvejes af de potentielle kliniske fordele.
While the carcinogenic potential in humans is unknown, these data suggest that a carcinogenic risk to humans is outweighed by the potential clinical benefit.
I prækliniske toksikologiske undersøgelser blev det påvist, at behandling med abacavir øgede levervægten hos rotter og aber.
In pre-clinical toxicology studies, abacavir treatment was shown to increase liver weights in rats and monkeys.
16 Let myocardial degeneration i hjertet hos mus og rotter blev observeret efter administration af abacavir i to år.
Mild myocardial degeneration in the heart of mice and rats was observed following administration of abacavir for two years.
I reproduktionstoksicitetsundersøgelser blev der observeret embryo - og føtal- toksicitet hos rotter, men ikke hos kaniner.
In reproductive toxicity studies, embryo and foetal toxicity have been observed in rats but not in rabbits.
Disse fund inkluderede nedsat fostervægt, føtale ødemer og øget antal skeletalevariationer/ misdannelser, tidlig intrauterin død og dødsfødsler.
These findings included decreased foetal body weight, foetal oedema, and an increase in skeletal variations/ malformations, early intra-uterine deaths and still births.
Der kan ikke drages nogen konklusion med hensyn til det teratogene potentiale for abacavir som følge af denne embryo - og føtal - toksicitet.
No conclusion can be drawn with regard to the teratogenic potential of abacavir because of this embryo-foetal toxicity.
En fertilitetsundersøgelse hos rotter viste, at abacavir ikke påvirkede hanlig eller hunlig fertilitet.
A fertility study in the rat has shown that abacavir had no effect on male or female fertility.
Mikrokrystallinsk cellulose Natriumstivelsesglycollat Magnesiumstearat Kolloid vandfri silica
Microcrystalline cellulose Sodium starch glycollate Magnesium stearate Colloidal anhydrous silica
Triacetin Metylhydroxypropylcellulose Titandioxid Polysorbat 80 Gult jernoxid
Triacetin Methylhydroxypropylcellulose Titanium dioxide Polysorbate 80 Iron oxide yellow
Polyvinylklorid/ folie- blisterpakninger indeholdende 60 tabletter.
Polyvinyl chloride/ foil blister packs containing 60 tablets.
Ziagen 20 mg/ ml oral opløsning
Ziagen 20 mg/ ml oral solution
1 ml oral opløsning indeholder 20 mg abacavir (som sulfat).
Oral solution containing 20 mg/ ml of abacavir (as sulfate).
Sorbitol (E420) 340 mg/ ml Methylparahydroxybenzoat (E218) 1, 5 mg/ ml Propylparahydroxybenzoat (E216) 0, 18 mg/ ml
Sorbitol (E420)340 mg/ ml Methyl parahydroxybenzoate (E218) 1.5 mg/ ml Propyl parahydroxybenzoate (E216) 0.18 mg/ ml
Fordelen ved Ziagen er hovedsageligt påvist i undersøgelser med kombinationsbehandling med et to gange daglig regime, hos voksne behandlingsnaive patienter (se afsnit 5. 1).
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).
Den anbefalede dosis Ziagen er 600 mg daglig (30 ml).
Adults and adolescents: the recommended dose of Ziagen is 600 mg daily (30 ml).
Dette kan administreres som enten 300 mg (15 ml) to gange daglig eller som 600 mg (30 ml) én gang daglig (se afsnit 4. 4 og 5. 1).
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).
Patienter der skifter til én gang daglig regimet skal tage 300 mg (15 ml) to gange daglig, og skifte til 600 mg (30 ml) én gang daglig den følgende morgen.
Patients changing to the once daily regimen should take 300 mg (15 ml) twice a day and switch to 600 mg (30 ml) once a day the following morning.
Hvor et én gang dagligt regime er foretrukket om aftenen, skal 300 mg (15 ml) Ziagen kun tages den første morgen, efterfulgt af 600 mg (30 ml) om aftenen.
Where an evening once daily regimen is preferred, 300 mg (15 ml) of Ziagen should be taken on the first morning only, followed by 600 mg (30 ml) in the evening.
Skiftes der tilbage til et to gange daglig regime, skal patienterne fuldføre dagens behandling og begynde med 300 mg (15 ml) to gange daglig den følgende morgen.
When changing back to a twice daily regimen, patients should complete the day's treatment and start 300 mg (15 ml) twice a day the following morning.
600 mg (30 ml) daglig.
Children from three months to 12 years: the recommended dose is 8 mg/ kg twice daily up to a maximum of 600 mg (30 ml) daily.
De tilgængelige data for brugen af Ziagen til denne aldersgruppe er begrænsede (se afsnit 5. 2).
19 Children less than three months: the data available on the use of Ziagen in this age group are very limited (see section 5.2).
Ziagen findes også som tabletter.
Ziagen is also available as a tablet formulation.
20 4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
4.4 Special warnings and precautions for use
I PREDICT- 1- studiet blev der anvendt kutantest til opsporingen, men det har ingen berettigelse i praksis og bør derfor ikke anvendes klinisk.
20 management of patients and therefore should not be used in the clinical setting.
Andre tegn og symptomer kan omfatte tegn og symptomer fra luftvejene såsom åndenød, ondt i halsen, hoste og unormale fund ved røntgen af thorax (fortrinsvist infiltrater, der kan lokaliseres), gastrointestinale symptomer, såsom kvalme, opkastning, diarré eller abdominalsmerter, og det kan lede til fejldiagnosticering af overfølsomhed som respiratorisk sygdom (pneumoni, bronkitis, pharyngitis) eller gastroenteritis.
Other signs and symptoms may include respiratory signs and symptoms such as dyspnoea, sore throat, cough and abnormal chest x-ray findings (predominantly infiltrates, which can be localised), gastrointestinal symptoms, such as nausea, vomiting, diarrhoea, or abdominal pain, and may lead to misdiagnosis of hypersensitivity as respiratory disease (pneumonia, bronchitis, pharyngitis), or gastroenteritis.
21 Patienter som får diagnosen overfølsomhedsreaktion, mens de er i behandling, SKAL omgående stoppe med at tage Ziagen.
Patients who are diagnosed with a hypersensitivity reaction whilst on therapy MUST discontinue Ziagen immediately.
Dette skyldes, at det på nuværende tidspunkt er vanskeligt at skelne mellem udslæt forårsaget af disse lægemidler og overfølsomhedsreaktioner på grund af abacavir.
This is because it is currently difficult to differentiate between rashes induced by these products and abacavir related hypersensitivity reactions.
• Forholdsregler efter en afbrydelse af Ziagen behandling
• Management after an interruption of Ziagen therapy
Desuden er der i meget sjældne tilfælde rapporteret overfølsomhedsreaktioner hos patienter, der har genoptaget behandlingen, og som ikke havde haft nogle forudgående symptomer på en overfølsomhedsreaktion.
Moreover, on very rare occasions hypersensitivity reactions have been reported in patients who have restarted therapy, and who had no preceding symptoms of a hypersensitivity
- Alle patienter bør påmindes om at læse indlægssedlen, som findes i Ziagenpakningen.
- each patient should be reminded to read the Package Leaflet included in the Ziagen pack.
De bør
They
mindes om vigtigheden af at tage oplysningskortet, som findes i pakningen, ud og altid have det med sig.
should be reminded of the importance of removing the Alert Card included in the pack, and keeping it with them at all times.
Der foreligger rapporter med sen- reaktioner i form af neurologiske dysfunktioner (hypertoni, kramper, usædvanlig opførsel).
Whether the
Det er uvist om disse neurologiske dysfunktioner er forbigående eller vedvarende.
22 neurological disorders are transient or permanent is currently unknown.
Fordelen ved abacavir som et én gang daglig regime bygger hovedsageligt på et studie udført i kombination med efavirenz og lamivudin, i antiretroviral- naive voksne patienter (se afsnit 5. 1).
Once daily administration (abacavir 600 mg): the benefit of abacavir as a once daily regimen is mainly based on a study performed in combination with efavirenz and lamivudine, in antiretroviral- naïve adult patients (see section 5.1).
Ziagens sikkerhed og effekt er ikke blevet klarlagt hos patienter med betydende, underliggende leversygdom.
Liver disease: the safety and efficacy of Ziagen has not been established in patients with significant underlying liver disorders.