qanastek/EMEA-V3 huggingface dataset:
Liver disease: the safety and efficacy of Ziagen has not been established in patients with significant underlying liver disorders.
Is- sigurtà u l- effikaċja ta` Ziagen għadhom ma ġewx stabbiliti f` pazjenti li għandhom mard fil- fwied sinifikanti.
A pharmacokinetic study has been performed in patients with mild hepatic impairment.
Sar studju farmakokinetiku f`pazjenti b’ indeboliment epatiku ħafif.
Excipients:
Sustanzi attivi:
Ziagen oral solution contains 340 mg/ ml of sorbitol.
It- tahlita ta`Ziagen li tittiehed mill- ħalq fiha 340 mg/ ml ta` sorbitol.
When taken according to the dosage recommendations each 15 ml dose contains approximately 5 g of sorbitol.
Meta tittiehed skond id- doża rakkomandata, kull doża ta` 15 ml fiha madwar 5g ta` sorbitol.
23 problems of fructose intolerance should not take this medicine.
Pazjenti li jbgħatu minn fructose intolerance ereditarja m’ għandhomx jieħdu din il- mediċina.
Sorbitol can have a mild laxative effect.
Sorbitol jista jkollu effett lassativ ħafif.
The calorific value of sorbitol is 2.6 kcal/ g.
Sorbitol għandu kaloriji ta ’ 2. 6kcal/ g.
Ziagen oral solution also contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).
Il- mistura ta ’ Ziagen fiha wkoll methyl parahydroxybenzoate u propyl parahydroxybenzoate li jistgħu jagħmlu reazzjonijiet allerġiċi (jistgħu jiġru aktar tard)
Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterium infections, and Pneumocystis carinii pneumonia.
Eżempji rilevanti jinkludu retinite b’ ċitomegalovirus, infezzjonijiet mikobatterjali lokali jew mifruxa pulmonite b’ Pneumocvstis carinii.
Transmission: patients should be advised that current antiretroviral therapy, including Ziagen, have not been proven to prevent the risk of transmission of HIV to others through sexual contact or blood contamination.
25 Tixrid ta ’ HIV: il- pazjenti għandhom ikunu avżati li t- terapija antiretrovirali li hawn sa llum, incluż Ziagen, għadhom ma ġewx pruvati li jneħħu r- riskju tat- tixrid ta` l- HIV lill- ħaddieħor waqt kuntatt sesswali jew kontaminazzjoni tad- demm.
Based on the results of in vitro experiments and the known major metabolic pathways of abacavir, the potential for P450 mediated interactions with other medicinal products involving abacavir is low.
Fuq il- bażi ta ’ riżultati ta ’ esperimenti in vitro u r- reazzjonijiet metaboliċi prinċipali magħrufa ta ’ abacavir, il- possibiltà ta` interazzjonijiet permezz ta ’ P450 ma 'prodotti mediċinali li fihom abacavir hija baxxa.
Methadone: in a pharmacokinetic study, coadministration of 600 mg abacavir twice daily with methadone showed a 35% reduction in abacavir Cmax and a one hour delay in tmax but the AUC was unchanged.
Methadone: waqt studji farmakokinetiċi, meta 600 mg ta` abacavir darbtejn kuljum ingħata ma 'methadone kien hemm tnaqqis ta ’ 35% fis- Cmax ta ’ abacavir u t- tmax żdiedet b' siegħa, iżda l`AUC ma nbidilx.
24 Retinoids: retinoid compounds are eliminated via alcohol dehydrogenase.
Retinojdi: is- sustanzi retinojdi jiġu eliminati permezz ta ’ l- alcohol dehydrogenase.
Interaction with abacavir is possible but has not been studied.
Interazzjoni b` abacavir hija possibbli iżda għadha ma ġietx studjata.
Additionally, it is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Minbarra hekk, huwa rrakkomandat li, nisa infettati bl- HIV ma jreddgħux lit- trabi tagħhom għal ebda raġuni sabiex ma tinxteridtx il- marda ta` l- HIV.
4.8 Undesirable effects
26 4. 8 Effetti mhux mixtieqa
In clinical studies, approximately 5% of subjects receiving abacavir developed a hypersensitivity reaction.
Minn studji kliniċi li saru, nstab li bejn wieħed u ieħor ir- rata ta` 45% tas- suġġetti li jirċievu abacavir ikollhom reazzjoni ta` sensittività eċċessiva.
In clinical studies with abacavir 600 mg once daily the reported rate of hypersensitivity remained within the range recorded for abacavir 300 mg twice daily.
Fi studji kliniċi b’ abacavir 600mg darba kuljum, ir- rata ta ’ sensittività eċċessiva rrappurtata baqgħat fl- istess limitu rreġistrat għal abacavir 300mg darbtejn kuljum.
Fever, lethargy, malaise, oedema, lymphadenopathy, hypotension, conjunctivitis, anaphylaxis
Deni, letarġija, ħass ħażin, edima, limfadenopatija, pressjoni Imħalltin baxxa ħafna, konġunktivite, anafilassi
Neurological/ Psychiatry
Uġigħ ta` ras, parasteżija Newroloġika/ Psikjatrija
Headache, paraesthesia
Limfopenja Ħematoloġiċi
Kivexa, Trizivir).
Kivexa Trizivir).
Many of those listed below occur commonly (nausea, vomiting, diarrhoea, fever, lethargy, rash) in patients with abacavir hypersensitivity.
Ħafna minn dawn li huma mniżżla hawn taħt huma komuni (nawżeja, rimettar, dijarrea, deni, letarġija raxx) f` pazjenti b`sensittività eċċessiva għal abacavir.
If Ziagen has been discontinued in patients due to experiencing any one of these symptoms and a decision is made to restart a medicinal product containing abacavir, this must be done in a setting where medical assistance is readily available (see section 4.4.).
Jekk Ziagen kien twaqqaf f’ xi pazjenti minħabba li kien instab li kellhom xi wieħed minn dawn is- sintomi u reġgħet ttieħdet id- deċiżjoni sabiex jerġa jibda jingħata prodott medicinali li fih abacavir, dan għandu jingħata f`sitwazzjonijiet fejn ikun hemm assistenza medika lesta (see section 4. 4.).
Very rarely cases of erythema multiforme, Stevens Johnson syndrome or toxic epidermal necrolysis have been reported where abacavir hypersensitivity could not be ruled out.
Rari ħafna każijiet ta ’ erythema multiforme, sindromu ta ’ Stevens Johnson jew Nekroliżi tossika epidermali dehru meta reazzjoni ta ’ sensittività eċċessiva għal abacavir ma setghatx tiġi eskluża.
26 Many of the adverse reactions have not been treatment limiting.
Ħafna mill- effetti avversi ma jfixklux il- kura.
Gastrointestinal disorders Common: nausea, vomiting, diarrhoea Rare: pancreatitis
28 Mard gastro- intestinali Komuni: nawżeja, rimettar, dijarrea Rari: pankrejatite
Cases of lactic acidosis, sometimes fatal, usually associated with severe hepatomegaly and hepatic steatosis, have been reported with the use of nucleoside analogues(see section 4.4).
Każijiet ta` aċidożi lattika, ġieli fatali, normalment assoċjati ma 'epatomegalija severa u stejatożi epatika, ġew rappurtati waqt l- użu ta` analogi tan- nuklejosajd (ara sezzjoni 4. 4).
In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART) an inflammatory reaction to asymptomatic or residual opportunistic infections may arise (see section 4.4).
(ara sezzjoni 4. 4)
Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART).
Każijet ta ’ nekrożi fl- għadam instab li huwa partikolarment aktar komuni f’ pazjenti b’ fatturi ta ’ riskju magħrufa, b’ HIVavvanzat u/ jew użu ta ’ terapija antiretrovirali kombinata (TARK) fit- tul.
27 5.
29 5.
Abacavir is metabolised intracellularly to the active moiety, carbovir 5’ - triphosphate (TP).
Abacavir jiġi mmetaboliżżat fiċ- ċelloli għal sustanza attiva, carbovir 5 ’ - triphoshate (TP).
It has been shown to be additive in combination with didanosine, lamivudine and stavudine.
Intwera li jkun hemm effett addittiv meta jingħata ma` didanosine, zalcitabine, lamivudine u stavudine.
Abacavir-resistant isolates of HIV-1 have been selected in vitro and are associated with specific genotypic changes in the reverse transcriptase (RT) codon region (codons M184V, K65R, L74V and Y115F).
Reżistenza in vitro: Iżolati ta` l- HIV- 1 reżistenti għal abacavir ġew magħżula in vitro u huma assoċjati ma 'tibdiliet ġenotipiċi speċifiċi tar- reverse transcriptase (RT) codon region (codons M184V, K65R, L74V u Y115F).
Viral resistance to abacavir develops relatively slowly in vitro, requiring multiple mutations for a clinically relevant increase in EC50 over wild-type virus.
Reżistenza virali għal abacavir tiżviluppa relattivament bil- mod in vitro li jirrikjedu bosta mutazzjonijiet sabiex tintlaħaq żieda klinikament rilevanti fl- EC50 fuq dak tal- vajrus li jinsab fin - natura.
lamivudine + NNRTI
lamivudine + NNRTI
TAMs might be selected when thymidine analogs are associated with abacavir.
MAT jistgħu ikunu magħżula meta analogi ta ’ thymidine ikollhom x’ jaqsmu ma ’ abacavir.
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 (22/ 86, 26%)..
F’ meta - analiżi ta’ sitt studji kliniċi, l- MAT ma kienux magħżula minn sistemi ta ’ kura li fihom abacavir mingħajr zidovudine (0/ 127), imma kienu magħżula minn sistemi ta ’ kura li fihom abacavir u l - analogu ta ’ thymidine zidovudine (22/ 86, 26%).
Clinically significant reduction of susceptibility to abacavir has been demonstrated in clinical isolates of patients with uncontrolled viral replication, who have been pre-treated with and are resistant to other nucleoside inhibitors.
Tnaqqis klinikament sustanzjali fis- suxxettibilita ’ ta ’ abacavir deher f’ iżolati kliniċi ta ’ pazjenti, b’ replikazzjoni mingħajr kontroll tal- virus, li kienu 30 ttrattati minn qabel bi u huma reżistenti għall- inibituri ta ’ nukleosidi oħra.
In a meta-analysis of five clinical trials where abacavir was added to intensify therapy, of 166 subjects, 123 (74%) had M184V/ I, 28 50 (30%) had T215Y/ F, 45 (27%) had M41L, 30 (18%) had K70R and 25 (15%) had D67N.
F’ meta- analiżi ta ’ ħames studji kliniċi fejn żdied abacavir biex iqawwi t- terapija, minn 166 suġġett, 123 (74%) kellhom M184V/ I, 50( 30%) kellhom T215Y/ F, 45 (27%) kellhom M41L, 30 (18%) kellhom K70R u 25 (15%) kellhom D67N.
Week 4 Baseline (n = 166) Reverse
4 Ġimgħa Mutazzjoni tal - (n = 166) lina bażi ta ’
vRNA
copies/ mL vRNA
PIs or NNRTIs) is unlikely.
Cross- resistance bejn abacavir u anitretrovirali ta ’ tip ieħor (eż PIs jew NNRTIs) mhix probabli.
Twice daily (300 mg) administration:
31 Doża (300mg) darbtejn kuljum:
In adults treated with abacavir in combination with lamivudine and zidovudine the proportion of patients with undetectable viral load (< 400 copies/ ml) was approximately 70% (intention to treat analysis at 48 weeks) with corresponding rise in CD4 cells.
F’ pazjenti adulti li qed jingħataw abacavir ma ’ lamivudine u zidovudine il- proporzjon ta` pazjenti b’ viral load li ma jitkejjilx (< 400 copies/ ml) kien bejn wieħed u ieħor ta` 70% (intent- to- treat l- analiżi fi żmien 48 ġimgħa) b`żieda korrispondenti f`ċelloli CD4.
29 One randomised, double blind, placebo controlled clinical study in adults has compared the combination of abacavir, lamivudine and zidovudine to the combination of indinavir, lamivudine and zidovudine.
Studju kliniku fl- adulti randomised, double blind, kontrollat bil- plaċebo, qabbel l- użu ta ’ abacavir, lamivudine u zidovudine mogħtija flimkien ma ’ l- użu ta ’ indinavir, lamivudine u zidovudine mogħtija flimkien.
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).
Ghalkemm effett antivirali simili deher bejn il- kura b’ abacavir u indinavir f`termini tan- numru ta ’ pazjenti b` viral load li ma jitkejjilx (≤400 kopji/ ml; analiżi ta ’ l- intenzjoni għal- kura (ITT), 47% kontra 49%; bħala analiżi tal- kura (AT), 86% kontra 94% għal kombinazzjonijiet ta’ abacavir u ta ’ indinavir rispettivament), ir- riżultati wrew li l- kombinazzjonijiet ta ’ indinavir kienu aħjar, l- aktar f’ dak il- grupp żgħir ta ’ pazjenti b`viral load għoli (> 100, 000 kopji/ ml fil- linja bażi; ITT, 46% kontra 55%; AT, 84% kontra 93% għal abacavir u indinavir rispettivament).
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.
Fi studju kliniku kkontrollat double- blind f’ aktar minn ċentru wieħed, (CAN 30024), 654 pazjent infettati bl- HIV u li qatt ma ingħatalhom kura antiretrovirali, irċevew b’ mod randomised jew abacavir 300mg jew zidovudine 300mg darbtejn kuljum, kemm flimkien ma ’ lamivudine 150mg darbtejn kuljum u efavirenz 600mg darba kuljum.
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 kien studju kliniku kkontrollat bil- plaċebo, randomised (1: 1: 1) double- blind, li sar f’ 1147 adult infettat bl- HIV- 1 li qatt ma ħadu terapija antiretrovirali, fejn tqabblu 3 reġimenti: zidovudine (ZDV), lamivudine (3TC), abacavir (ABC), efavirenz (EFV) ma ’ ZDV/ 3TC/ EFV ma ’ ZDV/ 3TC/ ABC.
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).
Wara li kienu segwiti għall- 32 ġimgħa, it- terapija triplika bit- tlett nukleosidi ZDV/ 3TC/ ABC instabet li kienet inferjuri viroloġikament għaż- żewġ friegħi l- oħra irrespettivament mill- piż virali tal- linja bażi (< jew > 100, 000 kopja kull ml), b’ 26% tas- suġġetti fuq il- fergħa ZDV/ 3TC/ ABC, 16% fuq il- fergħa ZDV/ 3TC/ EFV u 13% fuq il- fergħa ta ’ erbgħa mediċini li kienu kkatergoriżżati bħala falliment viroloġiku (HIV RNA > 200 kopji kull ml.
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.
Wara li ġew segwiti għal medja ta ’ 144 ġimgħa, 25% tas- suġġetti fuq il- fergħa ZDV/ 3TCABC/ EFV u 26% fuq il - fergħa ZDV/ 3TC/ EFV ġew kategoriżżati li kellhom falliment viroloġiku.
Virologic failure (HIV 32 weeks RNA > 200 copies/ ml) 144 weeks
Falliment virologiku HIV RNA > 200 kopja/ ml
Virologic success (48 weeks HIV RNA < 50 copies/ ml)
Suċċess viroloġiku (48ġimgħa HIV RNA < 50kopja/ ml
• Therapy naïve children
Tfal li qatt ma ingħatalhom kura qabel
30 • Therapy experienced patients
• Pazjenti esperjenzati bit- terapija
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.
Studju kkontrollat double- blind ta ’ 48 ġimgħa b’ 770 adult infettati bl- HIV li qatt ma ingħatalhom kura qabel,, f’ aktar minn ċentru wieħed (CAN 30021), wera li d- doża ta ’ darba kuljum ta ’ abacavir hija effettiva.
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.
F’ kampjun żgħir għal analiżi ġenotipika, kien hemm it- tendenza ta ’ rata aktar għolja ta ’ mutazzjonijiet assoċjati ma NRTI fid- doża ta ’ darba kuljum meta mqabbla mad- doża ta’ abacavir darbtejn kuljum.
No firm conclusion could be drawn due to the limited data derived from this study.
L- ebda konklużżjoni soda ma setgħet tkun deċiża minħabba n - nuqqas ta ’ informazzjoni li ħarget min dan l- istudju.
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.
33 u 300 mg lamivudine darba kuljum, it- tnejn mgħotija flimkien ma ’ tenovir u PI jew NNRTI għal 48 ġimgħa.
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).
Ir- riżultati indikaw li l- grupp li ħadu Kivexa ma kienux inferjuri għall- grupp li ħadu abacavir darbtejn kuljum, bażati fuq tnaqqis simili fl- HIV- 1 RNA kif imkejjel b’ żona medja taħt il- curve minus baseline (AAUCMB, - 1. 65 log10 kopji/ ml kontra - 1. 83 log10kopji/ ml rispettivament, 95% CI - 0. 13, 0. 38).
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.
Fl- istudju ESS30008, 260 pazjent b’ soppressjoni viroloġika fuq sistema ta ’ terapija first line bi 300 mg abacavir u 150 mg lamivudine, it- tnejn meħudin darbtejn kuljum flimkien ma ’ PI jew NNRTI, ġew randomised biex ikomplu b’ din is- sistema jew jaqilbu għal abacavir/ lamivudine FDC flimkien ma ’ PI jew NNRTI għal 48 ġimgħa.
Results indicate that the FDC group was associated with a similar virologic outcome (non- 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).
Ir- riżultati indikaw li l- grupp ta ’ Kivexa kien assoċjat ma ’ riżultat viroloġiku simili mhux inferjuri, paragunat mall- grupp ta ’ abacavir u lamivudine, bażati fuq proporzjonijiet ta ’ individwi b ’ HIV- 1 RNA < 50 kopji/ ml (90% u 85% rispettivament, 95% CI - 2. 7, 13. 5).
31 Abacavir penetrates the cerebrospinal fluid (CSF) (see section 5.2), and has been shown to reduce HIV-1 RNA levels in the CSF.
Abacavir jidħol fil- fluwidu ċerebrospinali (CSF) (ara sezzjoni 5. 2), u deher li jnaqqas il- livelli ta` l - HIV- 1 RNA fis- CSF.
There are no differences observed between the AUC for the tablet or solution.
Ma hemm l- ebda differenza osservata bejn l- AUC tal- pilloli jew tas- soluzzjoni.
Metabolism: abacavir is primarily metabolised by the liver with approximately 2% of the administered dose being renally excreted, as unchanged compound.
34 Metaboliżmu: abacavir huwa primarjament metabolizzat mill- fwied u bejn wieħed u ieħor 2% tad - doża li tingħata titneħħa mill- ġisem permezz tal- kliewi, bħala sustanza mhux mibdula.
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.
Ir- rottot tal - metaboliżmu prinċipali fil- bnedmin huwa bl- alcohol dehydrogenase u b`glucuronidation sabiex jiproduċi l- 5 ’ - carboxylic acid u 5 ’ - glucuronide li jirrappreżentaw 66% tad- doża lit kun ittieħdet.
Elimination of abacavir is via hepatic metabolism with subsequent excretion of metabolites primarily in the urine.
It - tneħħija mil- ġisem ta ’ abacavir issir b’ metaboliżmu fil- fwied u s- sustanzi li jiffurmaw jitneħħew primarjament fl- urina.
Intracellular pharmacokinetics
Farmakokinetiċi intraċellulari
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.
Fi studju crossover f’ 27 pazjent infettat bl- HIV, espożizzjoni għal carbovir- TP ġewwa ċ- ċellola kienu aktar għoljin għas- sistema ta ’ kura b’ abacavir 600mg darba kuljum (AUC24, ss + 32%, Cmax 24, ss + 99% u C trough + 18%) meta mqabbla mas- sistema ta ’ kura ta ’ darbtejn kuljum.
32 Special populations
Gruppi speċjali:
5.3 Preclinical safety data
35 5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Malignant tumours occurred in the preputial gland of males and the clitoral gland of females of both species, and in rats in the thyroid gland of males and the liver, urinary bladder, lymph nodes and the subcutis of females.
Fil- firien maskili ħarġu fil- glandola tat- tirojde, u fil- fwied, fil- bużżieqa ta ’ l- urina, fil- glandoli żgħar limfatiċi u fis- subkute tal- firien femminili.
The systemic exposure at the no effect level in mice and rats was equivalent to 3 and 7 times the human systemic exposure during therapy.
L- esponiment tas- sistema għall- livell ta ’ bla effett fil- ġrieden u fil- firien kienet ekwivalenti għal minn 3 u 7 darbiet ta` l- esponiment sistemiku uman li jkun hemm waqt it- terapija.
33 In reproductive toxicity studies, embryo and foetal toxicity have been observed in rats but not in rabbits.
Fi studji tossiċi dwar ir- reproduttività, kein hemm effett tossiku fuq l- embriju u l- fetu fil- firien iżda mhux fil- fniek.
Sorbitol 70% (E420) Saccharin sodium Sodium citrate Citric acid anhydrous Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Propylene glycol (E1520) Maltodextrin Lactic acid Glyceryl triacetate Natural and artificial strawberry and banana flavours Purified water Sodium hydroxide and/ or hydrochloric acid for pH adjustment.
Sodium hydroxide u/ jew hydrochloric acid biex taġġusta l- pH
6.2 Incompatibilities
36 6. 2 Inkompatibilitajiet
2 months
Minn meta tkun ftaħt il- flixkun: xahrejn
Ziagen oral solution is supplied in high density polyethylene bottles with child-resistant closures, containing 240 ml of oral solution.
Il- flixkun jikkontjeni 240 ml ta’ likwidu.
A 10 ml polypropylene oral dosing syringe and a polyethylene adapter are also included in the pack.
Siringa tal- polypropylene biex tkejjel id- doża li tittieħed mill- ħalq ta’ volum 10 ml kif ukoll adapter tal- polyethylene huma provdudi fil- pakkett.
6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal imaniġġar ieħor
A plastic adapter and oral dosing syringe are provided for accurate measurement of the prescribed dose of oral solution.
Siringa biex tkejjel id- doża eżatta tal- likwidu li jittieħed mill- ħalq, skond ir- riċetta tat- tabib, hija provduta.
The adapter is placed in the neck of the bottle and the syringe attached to this.
Fil- pakkett jinstab ukoll tagħrif għall- użu.
8 July 2004
8 Lulju 2004
35 ANNEX II
37 ANNESS II
B CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ
Film-coated Tablets
Pilloli miksijin b’ rita
Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations) Priory Street Ware Herts SG12 0DJ United Kingdom
Glaxo Wellcome Operations Priory Street Ware Hertfordshire SG 12 0DJ Ir- Renju Unit.
Grunwaldzka 189 60-322 Poznan Poland
Grunwaldzka 189 60- 322 Poznan Il- Polonja
Oral Solution
Soluzzjoni li tittieħed mill- ħalq
KG Industriestrasse 32-36 23843 Bad Oldesloe Germany
KG Industrie Strasse 32- 36 23843 Bad Oldesloe Il- Ġermanja
Medicinal product subject to restricted medical prescription (See Annex I Summary of Product Characteristics, 4.2).
Sommarju tal- Karatteristiċi tal - Prodott, 4. 2)
Pharmacovigilance System The MAH must ensure that the system of pharmacovigilance, as described in version 6.2 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza L- MAH għandu jassigura li s- sistema ta ’ farmakoviġilanza, kif deskritta f’ verżjoni 6. 2 ippreżentata fil - Module 1. 8. 1 ta ’ l- Applikazzjoni għat- Tqegħid fis- Suq hija f’ postha u tiffunzjona qabel u waqt li l - prodott ikun fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 02 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan dwar il- Maniġġjar ta ’ Riskju L- MAH jimpenja ruħu li jwettaq l- istudji u l- attivitajiet addizzjonali ta ’ farmakoviġilanza ddettaljati fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem fil- verżjoni 02 tal- Pjan dwar il- Maniġġjar ta ’ Riskju
37 As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
39 (RMP) ippreżentat fit- Taqsima 1. 8. 2 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq u fl- aġġornament sussegwenti tal- RMP miftehma mas- CHMP.
- When new information is received that may impact on the current Safety Specification,
L- RMP aġġornat għandu jiġi ppreżentat fl- istess żmien tar- Rapport ta ’ Sigurtà Aġġornat Perjodikament (PSUR) li jmiss, skond ir- regolament tas- CHMP dwar Sistemi għal Maniġġjar ta ’ Riskji għal prodotti mediċinali għall- użu fil- bniedem.
- Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Barra minn hekk, RMP aġġornat għandu jiġi ppreżentat: • Meta tasal informazzjoni ġdida li jista ’ jkollha effett fuq l- ispeċifikazzjoni tas- sigurtà kurrenti, fuq il- Pjan ta ’ Farmakoviġilanza kurrenti jew fuq l- attivitajiet għat- tnaqqis tar- riskji. • Fi żmien 60 ġurnata wara li tkun intlaħqet xi mira importanti (ta ’ farmakoviġilanza jew ta ’ tnaqqis ta ’ riskji) • Fuq talba ta ’ l- EMEA
The Marketing Authorisation Holder will submit Periodic Safety Update Reports and other safety information annually.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq għandu jissottometti Rapporti Perjodiċi ta ’ Aġġornament dwar Sigurta ’ (PSUR) u informazzjoni oħra dwar sigurta ’ kull sena.
38 ANNEX III
40 ANNESS III
40 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
42 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA - PILLOLI
Ziagen 300 mg film-coated tablets Abacavir
Ziagen 300 mg pillola miksija b`rita Abacavir
Each film-coated tablet contains abacavir 300 mg (as sulfate).
Kull pillola miksija b`rita fiha 300 mg abacavir
60 film-coated tablets Scored tablets
60 pillola miksija b`rita Pilloli mnaqqxa biex tkun tista ’ taqsamhom
Detach enclosed Alert Card, it contains important safety information
Neħħi l- Alert Card li tinsab fuq ġewwa, fiha informazzjoni importanti dwar is- sigurtà tal - mediċina.
WARNING!
ATTENZJONI!
In case of any symptoms suggesting hypersensitivity reactions, contact your doctor IMMEDIATELY.
F`kaz li jkollok xi sintomi ta` reazzjonijiet ta` sensittività eċċessiva, għamel kuntatt mat- tabib IMMEDJATAMENT.
“ Pull here” (with Alert card attached)
“ iġbed hawn ” (bl- Alert card li tinsab imwaħħla)
41 ALERT CARD TEXT
43 KITBA FUQ L- ALERT CARD
IMPORTANT - ALERT CARD ZIAGEN (abacavir sulfate) Tablets Carry this card with you at all times
IMPORTANTI - ALERT CARD PILLOLI ZIAGEN (abacavir sulfate) Żomm din il- card dejjem fuqek
Patients taking Ziagen may develop a hypersensitivity reaction (serious allergic reaction) which can be life-threatening if treatment with Ziagen is continued.
Pazjenti li qegħdin jieħdu Ziagen jista jkollhom reazzjonijiet ta` sensittività eċċesiva (reazzjonijiet ta ’ allerġija serja) li jistgħu jkunu ta` periklu għall- ħajja jekk titkompla l- kura b`Ziagen.
CONTACT YOUR DOCTOR IMMEDIATELY for advice on whether you should stop taking Ziagen if:
STAQSI LIT- TABIB TIEGĦEK IMMEDJATAMENT għall- parir biex tara jekk għandekx tieqaf tieħu Ziagen f’ każ li:
1) you get a skin rash OR 2) you get one or more symptoms from at least TWO of the following groups
1) ikollok raxx fuq il- ġilda JEW 2) ikollok wieħed jew aktar sintomi ta ’ mill- anqas TNEJN minn dawn il- gruppi li ġejjin:
- shortness of breath, sore throat or cough
- qtugħ ta`nifs, uġigħ fil- griżmejn jew sogħla
- nausea or vomiting or diarrhoea or abdominal pain
- nawżeja jew rimettar jew dijarrea jew uġigħ addominali
- severe tiredness or achiness or generally feeling ill
- għejja severa jew ituk weġat jew jekk ma tħossokx tiflaħ.
If you have discontinued Ziagen due to this reaction, YOU MUST NEVER TAKE Ziagen or any other abacavir containing medicine (i. e.
Jekk kont waqaft tieħu Ziagen minħabba din ir- reazzjoni, QATT M`GHANDEK TERĠA TIEĦU Ziagen jew xi mediċina li fiha abacavir (i. e.
Kivexa, Trizivir) again, as within hours you may experience a life-threatening lowering of your blood pressure or death.
Trizivir), minħabba li fi ftit sigħat tista titbaxxilek il - pressjoni f’ daqqa u tkun ta` periklu għall- ħajjtek, jew tmut.
(see reverse of card)
(ara fuq wara tal- card)
You should immediately contact your doctor if you think you are having a hypersensitivity reaction to Ziagen.
Għandek tgħid mill- ewwel lit- tabib tiegħek jekk taħseb li għandek xi reazzjoni ta` sensittività eċċessiva għal Ziagen.
Write your doctor ’ s details below:
Ikteb id- dettalji tat- tabib tiegħek hawn taħt:
Doctor:...................... .……………… Tel:.................. .……………………………………………..
ISEM TAT- TABIB:....................... …… Tel................... ……………………………………………..
If your doctor is not available, you must urgently seek alternative medical advice (e. g. the emergency unit of the nearest hospital).
Jekk it- tabib tiegħek ma jkunx dispost, għandek tfittex għajnuna medika oħra immedjatament (e. z. id- dipartiment ta` l- emergenza fl- eqreb sptar).
For general Ziagen information enquiries, contact GlaxoSmithKline…. Tel …………… (local company name and telephone number will be inserted here).
Għall- informazzjoni ġenerali fuq Ziagen, kellem lil GlaxoSmithKline …. Tel …………… (hawnhekk tnizzel l- isem tal- Kumpanija lokali u numru tat- telefon).
43 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
45 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Ziagen 300 mg tablets.
Ziagen 300 mg
NAME OF THE MARKETING AUTHORISATION HOLDER
2 ISEM TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
44 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
46 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON AND LABEL- ORAL SOLUTION
PAKKETT TA ’ BARRA U TIKKETTA TAL- FLIXKUN – SOLUZZJONI ORALI
Ziagen 20 mg/ ml oral solution Abacavir
Ziagen 20 mg/ ml soluzzjoni orali Abacavir
240 ml oral solution containing 20 mg/ ml abacavir (as sulfate)
Kontenut tal- flixkun 240 ml soluzzjoni orali fiha 20 mg/ ml ta ’ abacavir (bħala sulphate)
Contains amongst others: sorbitol (340 mg/ ml, E420), methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216).
Fih fost l- oħrajn: sorbitol (340 mg/ ml, E420), methyl parahydroxybenzoate (E218) u propyl parahydroxybenzoate (E216).
240 ml oral solution
240 ml soluzzjoni orali.
OTHER SPECIAL WARNING(S), IF NECESSARY
TWISSIJA/ JIET SPEĊJALI OĦRA, HEKK MEĦTIEĠA
In case of any symptoms suggesting hypersensitivity reactions, contact your doctor IMMEDIATELY.
F`kaz li tinnota xi sintomi ta` reazzjonijiet ta`sensittività eċċessiva, għamel kuntatt mat- tabib IMMEDJATAMENT.
45 ALERT CARD TEXT
47 KITBA FUQ L- ALERT CARD
IMPORTANT - ALERT CARD ZIAGEN (abacavir sulfate) Oral solution Carry this card with you at all times
IMPORTANTI - ALERT CARD PILLOLI ZIAGEN (abacavir sulfate) Żomm din il- card dejjem fuqek
Do not store above 30°C
Taħżinx f`temperatura `lfuq minn 30°C
Discard two months after first opening
Armi wara xaharejn minn meta tkun ftaħt il- pakkett
PACKAGE LEAFLET
49 B. FULJETT TA ’ TAGĦRIF
Ziagen 300 mg Film-Coated Tablets abacavir
Ziagen 300 mg Pilloli Miksija b’ Rita abacavir
Read all of this leaflet carefully before you start taking this medicine.
Aqra dan il- Fuljett kollu qabel tibda tieħu din il- mediċina
if their symptoms are the same as yours.
il- ħsara, anki jekk ikollom l- istess sintomi bħall- tiegħek.
HYPERSENSITIVITY REACTION
REAZZJONI TA ’ SENSITTIVITÀ EĊĊESSIVA
Patients taking Ziagen may develop a hypersensitivity reaction (serious allergic reaction) which can be life-threatening if treatment with Ziagen is continued.
Pazjenti li jieħdu Ziagen jistgħu jiżvilluppaw reazzjoni ta’ sensittività eċċessiva (allerġija qawwija) illi tista tipperikola il- ħajja jekk tkompli l- kura b' Ziagen.
It is essential you read the information on this reaction under “ Take special care with Ziagen ” in section 2 of this leaflet.
Huwa essenzjali li taqra l- informazzjoni fuq din ir- reazzjoni fis- sezzjoni ta ’ “ Oqgħod attent ħafna b’ Ziagen ” f’ sezzjoni 2 ta’ dan il- fuljett.
There is also an Alert Card included in the Ziagen pack, to remind you and medical staff about Ziagen hypersensitivity.
Hemm ukoll Alert Card inkluża fil - pakkett ta ’ Ziagen, biex ifakkar lilek u lill- istaff mediku dwar dan l- effett ta ’ sensittività eċċessiva ta` Ziagen.
This card should be removed and kept with you at all times.
Din il- kartuna għandha titneħħa mil- pakkett u tinżamm miegħek f’ kull ħin.
CONTACT YOUR DOCTOR IMMEDIATELY for advice on whether you should stop taking Ziagen if:
STAQSI LIT- TABIB TIEGĦEK IMMEDJATAMENT għall parir fuq jekk għandekx tieqaf tieħu Ziagen jekk:
you get a skin rash OR you get one or more symptoms from at least TWO of the following groups - fever - shortness of breath, sore throat or cough - nausea or vomiting or diarrhoea or abdominal pain - severe tiredness or achiness or generally feeling ill
ikollhokk raxx tal- ġilda JEW ikollok wieħed jew aktar sintomi ta ’ mill- anqas TNEJN minn dawn il - gruppi li ġejjin - deni - qtugħ ta`nifs, uġigħ fil- griżmejn jew sogħla - nawżeja jew rimettar jew dijarrea jew uġigħ addominali - għejja severa jew ituk weġat jew jekk ma tħossokx tiflaħ. - Jekk kont waqaft tieħu Ziagen minħabba din ir- reazzjoni, QATT M`GHANDEK TERĠA TIEĦU Ziagen jew xi mediċina li fiha abacavir (i. e.
Kivexa, Trizivir) again, as within hours you may experience a life-threatening lowering of your blood pressure or death.
Kivexa Trizivir), minħabba li fi ftit sigħat tista titbaxxilek il- pressjoni f’ daqqa u tkun ta` periklu għall- ħajjtek, jew tmut.
What Ziagen is and what it is used for 2.
X’ inhu Ziagen u għalxiex jintuża 2.
Before you take Ziagen 3.
Qabel ma tieħu Ziagen 3.
How to take Ziagen 4.
Kif għandek tieħu Ziagen 4.
How to store Ziagen 6.
Kif taħżen Ziagen 6.
WHAT ZIAGEN IS AND WHAT IT IS USED FOR
X’ INHU ZIAGEN U GĦALIEX JINTUŻA
Ziagen belongs to a group of antiviral medicines, also known as antiretrovirals, called nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Ziagen jifforma parti minn grupp ta ’ mediċini antivirali, mħarufin ukoll bħala antiretrovirali, msemmija nucleoside analogue reverse transcriptase inhibitors (NRTIs).
These are used to treat Human Immunodeficiency Virus (HIV) infection.
Dawn jintużaw sabiex jikkuraw l- infezzjoni tal- Vajrus ta ’ l- Immunodefiċjenza Umana (HIV).
Ziagen is used in combination with other antiretroviral medicines for the treatment of HIV infection.
51 Ziagen jintuża flimikien ma ’ mediċini antiretrovirali oħra għal- kura ta ’ l- infezzjoni tal- HIV.
It reduces HIV viral load, and keeps it at a low level.
Ziagen inaqqas il- HIV viral load, u jżommu f’ livell baxx.
It also increases CD4 cell counts.
Iżid ukoll in- numru taċ- ċelloli CD4.
CD4 cells are a type of white blood cell that play an important role in maintaining a healthy immune system to help fight infection.
Ċelloli CD4 għandhom rwol importanti sabiex iżommu fi stat tajjeb, is- sistema immunitarja sabiex din tiġġieled l - infezzjoni.
Response to treatment with Ziagen varies between patients.
Ir- rispons għal- kura b’ Ziagen ivarja minn pazjent għal ieħor.
Your doctor will be monitoring the effectiveness of your treatment.
It- tabib tiegħek ser ikun qed isegwi il- progress tal- kura tiegħek.
BEFORE YOU TAKE ZIAGEN
QABEL MA ’ TIEĦU ZIAGEN
Do not take Ziagen:
Tieħux Ziagen:
- if you are allergic (hypersensitive) to the active substance abacavir, which is also included in
- Jekk inti alleġiku (għandek sensittività eċċessiva) għas- sustanza attiva abacavir li ssibha wkoll
medicines called Kivexa and Trizivir.
f’ mediċini bħal Kivexa u Trizivir
- if you are allergic to any of the other ingredients in Ziagen
- Jekk inti allerġiku għall xi ingredjent ta ’ Ziagen
- if you have severe liver disease.
- Jekk inti għandek xi mard tal- fwied gravi.
If you are not sure about any of these please consult your doctor.
Jekk għandek xi dubji fuq dawn, ikkonsulta mat- tabib tiegħek.
Take special care with Ziagen
Oqgħod attent ħafna b’ Ziagen
Hypersensitivity reaction (serious allergic reaction):
Reazzjoni ta’ sensittività eċċessiva (reazzjoni allerġika qawwija):
About 5 in every 100 patients, who are treated with Ziagen, develop a hypersensitivity reaction to the active ingredient abacavir.
Xi 4 minn kull 100 pazjent, illi kienu kurati b’ Ziagen żviluppaw reazzjoni ta’ sensittività eċċessiva lejn is - sustanza attiva - abacavir.
The most common symptoms of this reaction are high temperature (fever) and a skin rash.
L- iżjed sintomu komuni ta ’ din ir- reazzjoni huwa deni għoli u raxx tal- ġilda.
Other frequently observed signs are nausea, vomiting, diarrhoea, abdominal pain and severe tiredness.
Sintomi komuni oħra huma dardir, remettar, dijarrea, uġigħ addominali, għejja qawwija.
Other symptoms may include joint or muscle pain, swelling of the neck, shortness of breath, sore throat, cough and headache.
Sintomi oħra jistgħu jinkludu uġigħ fil- ġogi jew muskoli, nefħa fl’ għonq, qtuħ ta’ nifs, uġigħ tal- gerżuma, sogħla u uġigħ ta ’ ras.
Occasionally inflammation of the eye (conjunctivitis), mouth ulcers or low blood pressure may occur.
Kultant jista jkun hemm konġunktivite, ulċeri fil- ħalq jew pressjoni baxxa.
The symptoms of this allergic reaction can occur at any time during treatment with Ziagen.
Is- sintomi ta ’ din ir- reazzjoni jistgħu jidhru waqt kura b' Ziagen.
However they usually occur in the first six weeks of treatment.
Iżda jekk iseħħu dan ikun fl- ewwel sitt gimgħat tal- kura.
The symptoms worsen with continued treatment and may be life-threatening if treatment is continued.
Is- sintomi jiħżienu bil- kura u jistgħu jkunu ta ’ periklu għall- ħajja, jekk it- trattatment jitkompla.
If you are caring for a child who is being treated with Ziagen, it is important that you understand the information about this hypersensitivity reaction.
Jekk inti qed tieħu ħsieb tifel/ tifla illi qed j/ tingħata kura b' Ziagen, huwa importanti illi inti tifhem l- informazzjoni fuq din ir- reazzjoni ta ’ sensittività eċċessiva.
If your child gets the symptoms described below it is essential that you follow the instructions given.
Jekk it - tifel/ tifla ikollu/ a sintomi deskritti hawn fuq, għandek timxi ma ’ dan li gej:
you get a skin rash OR you get one or more symptoms from at least TWO of the following groups - fever -shortness of breath, sore throat or cough -nausea or vomiting or diarrhoea or abdominal pain -severe tiredness or achiness or generally feeling ill
ikollok raxx fuq il- ġilda JEW ikollok wieħed jew aktar sintomi ta ’ mill- anqas TNEJN minn dawn il- gruppi li ġejjin: - deni - qtugħ ta`nifs, uġigħ fil- griżmejn jew sogħla - nawżeja jew rimettar jew dijarrea jew uġigħ addominali - għejja severa jew ituk weġat jew jekk ma tħossokx tiflaħ.
TAKE Ziagen or any other medicine containing abacavir (i. e.
Jekk kont waqaft tieħu Ziagen minħabba din ir- reazzjoni, QATT M`GHANDEK TERĠA TIEĦU Ziagen jew xi mediċina li fiha abacavir (i. e.
If you have stopped taking Ziagen for any reason, particularly because you think you are having side effects or for other illness, it is important that you contact your doctor before restarting.
52 Jekk waqaft tieħu Ziagen għal xi raġuni, l- aktar għax taħseb illi għandek xi effetti oħra, jew għax għandek xi mard ieħor, huwa importanti li tieħu l- parir tat- tabib tiegħek qabel ma terġa tibda l- kura.
Your doctor will check whether any symptoms you had may be related to this hypersensitivity reaction.
It- tabib jikkonferma miegħek jekk is- sintomi li qed tħoss humiex relatati ma ’ din ir- reazzjoni ta ’ sensittività eċċessiva.
If your doctor thinks there is a possibility that they were related, you will be instructed never to take Ziagen or any other medicine containing abacavir (i. e.
Jekk it- tabib tiegħek jaħseb illi s - sintomi li qed tħoss huma relatati ma ’ din ir- reazzjoni javżak sabiex qatt ma terġa tieħu l- mediċina Ziagen jew oħrajn li fihom is- sustanza attiva abacavir (i. e.
Kivexa, Trizivir) again.
Kivexa Trizivir).
It is important that you follow this advice.
Huwa importanti illi inti timxi ma ’ dan il- parir.
50 Occasionally life-threatening hypersensitivity reactions have occurred when Ziagen was restarted in patients who reported only one of the symptoms on the Alert Card before stopping.
Xi drabi, reazzjonijiet ta ’ sensittività eċċessiva ta ’ periklu għall- ħajja seħħew f’ pazjenti li reġgħu ħadu Ziagen wara li kienu waqfuh minħabba li kellhom wieħed biss mis- sintomi li jidhru fuq l- Alert Card qabel ma waqfuh.
On very rare occasions hypersensitivity has been reported when Ziagen was restarted in patients who had no symptoms of hypersensitivity before stopping.
F’ każijiet rari ħafna, reazzjonijiet ta ’ sensittività eċċessiva dehru f’ pazjenti li reġgħu ħadu Ziagen mingħajr ma kellhom l- ebda sintomu ta ’ sensittività eċċessiva waqt il- kura meta ħaduh l- ewwel darba.
If you are hypersensitive to Ziagen you should return all of your unused Ziagen for disposal.
Jekk inti allerġiku għal Ziagen, għandek tieħu lura l- mediċina li jkun baqalek biex tintrema.
Ask your doctor or pharmacist for advice.
Staqsi lit- tabib jew lill- ispizjar tiegħek għall- parir.
Lactic acidosis: the class of medicines to which Ziagen belongs (NRTIs) can cause a condition called lactic acidosis, together with an enlarged liver.
Aċidożi lattika: il- grupp ta ’ mediċini li jifforma parti minnhom Ziagen (NRTIs) jista jikkawża kundizzjoni msemmija Aċidożi lattika, kif ukoll tkabbir tal- fwied.
Lactic acidosis, if it occurs, usually develops after a few months of treatment.
Aċidożi lattika, jekk isseħħ, normalment jiżviluppa fi żmien ftit xħur wara li tibda l- kura.
Deep, rapid breathing, drowsiness, and non specific symptoms such as nausea, vomiting and stomach pain, might indicate the development of lactic acidosis.
Nifs fil- fond u frekwenti, sensazzjoni ta ’ ngħas, u sintomi mhux speċifiċi bħal dardir, rimattar u uġigħ addominali, jistgħu jindikaw l- iżvilupp ta ’ Aċidożi lattika.
This rare, but serious side effect occurs more often in women, particularly if very overweight.
Din il- kundizzjoni rari, imma serja, hija iżjed komuni fin- nisa, partikolarment jekk għandhom piż żejjed.
If you have liver disease you may also be more at risk of getting this condition.
Jekk issofri minn xi mard tal- fwied, għandek riskju akbar li jkollok din il - kundizzjoni.
While you are being treated with Ziagen, your doctor will monitor you closely for any signs that you may be developing lactic acidosis.
Waqt li tieħu Ziagen it- tabib tiegħek ser iżommok taħt osservazzjoni bir- reqqa sabiex jinduna b’ xi sintomi li jindikaw l- iżvilupp ta ’ Aċidożi lattika.
Fat distribution: redistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy.
Distribuzzjoni tax- xaħam: jista jkun hemm ukoll, tnaqqis, żieda jew tibdil fid- distribuzzjoni tax- xaħam tal- ġisem, waqt terapija retrovirali.
Liver disease/ hepatitis: please tell your doctor if you have a history of liver disease.
Mard tal- fwied: jekk jogħġbok kellem lit- tabib jekk ġieli batejt minn xi mard tal- fwied.
Patients with chronic hepatitis B or C and treated with antiretroviral agents are at increased risk of severe and potentially fatal liver adverse events and may require blood tests for monitoring of liver function.
Pazjenti b’ epatite B jew C kronika u li qegħdin jingħataw kura b' mediċini antiretrovirali huma f`riskju akbar li jsofru minn reazzjonijiet avversi tal- fwied severa jew fatalifuq il- fwied, u jista jkun hemm bżonn ta` testijiet tad- demm biex tkun monitorjata l- funzjoni tal- fwied.
If you have liver disease you may get higher amounts of abacavir in your blood, compared to people with a healthy liver.
Jekk għandek mard tal- fwied jista jkollok ammonti akbar ta ’ abacavir fid- demm, meta mqabbel Ma ’ persuni li għandhom l- fwied b`saħħtu.
Patients with liver disease being treated with Ziagen will be monitored closely for side effects, which may occur more frequently with higher doses of abacavir.
Pazjenti b`mard tal- fwied u li qed jingħataw Ziagen ikunu osservati bir- reqqa minħabba xi effetti mhux mixtieqa, li jistgħu jseħħu aktar spissi b`dożi għolja ta ’ abacavir.
Ziagen is not recommended if you have moderate liver disease.
Ziagen mhux rakkomandat jekk tbati minn mard moderat tal- fwied.
Discuss this with your doctor if you are unsure.
Tkellem mat- tabib tiegħek jekk m`intix ċert.
Pancreatitis: inflammation of the pancreas (pancreatitis) has been reported in some patients taking Ziagen.
Pankrejatite: uħud mill- pazjenti li kienu qed jieħdu Ziagen sofrew minn infjamazzjoni tal- frixa (pancreatite).
However it is not certain whether this is caused by Ziagen, other medications you may be taking or your HIV infection.
Madanakollu mhux magħruf jekk dan hux kawżat minn Ziagen, xi mediċini oħra li tista ’ tkun qed tieħu jew bl- infezzjoni ta ’ l- HIV tiegħek.
Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Xi pazjenti li jkunu fuq terapija antiretrovirali kombinata jistgħu jiżviluppaw marda fl- għadam imsejħa osteonekrożi (mewt tat- tessuti ta ’ l- għadam kawżata min nuqqas ta ’ demm
Ziagen helps to control your condition but is not a cure for HIV infection.
Ġenerali: Ziagen jgħin sabiex jikkontrolla l- kundizzjoni iżda ma jfejjaqx l- infezzjoni ta`l- HIV.
You will need to take it every day.
Ikun hemm il- bżonn li teħodha kuljum.
Do not interrupt your medication without first talking to your doctor.
Twaqqafx il- medikazzjoni qabel ma tkun kellimt lit- tabib.
If however, you suspect you are developing a hypersensitivity reaction contact your doctor immediately who will advise you whether you should stop taking Ziagen.
Madanakollu, jekk taħseb li qed jiżvillupawlek xi reazzjonijiet ta` sensittività eċċessiva (ara hawn fuq) kellem lit- tabib immedjatament u hu jgħidlek jekk għandekx twaqqaf Ziagen.
51 Treatment with Ziagen has not been shown to reduce the risk of passing HIV infection on to others by sexual contact or by blood transfer.
Il- kura b`Ziagen għadha m’ urietx li tista tnaqqas ir- riskju tat- tixrid ta` l- infezzjoni tal- HIV lill - ħaddieħor minn kuntatti sesswali jew mid- demm.
You should continue to use appropriate precautions to prevent this.
Int għandek tibqa tieħu l- prekawzjonijiet kif meħtieġa sabiex twaqqaf milli dan iseħħ.
You may continue to develop other infections and other illnesses associated with HIV disease.
Jistgħu jkomplu jiżvillupawlek infezzjonijiet u mard ieħor assoċjat mal- marda tal- HIV.
You should therefore keep in regular contact with your doctor while taking Ziagen.
Int għandek għalhekk tibqa f`kuntatt regolari mat- tabib waqt li qiegħed tieħu Ziagen.
Ziagen is unlikely to significantly interact with other medicines you are being treated with.
M’ huwiex komuni li Ziagen jkollu effett ma mediċini oħra li tkun qed tieħu.
If you are taking oral vitamin A related medicines, e. g. isotretinoin, you should inform your doctor, since these may also increase the amount of abacavir in your blood.
Jekk qiegħed tieħu mediċini relatati mall- Vitamina A, e. ż. isotretinoin, għandek tinforma lit- tabib tiegħek, billi dan jista ’ jżid l- ammont ta ’ abacavir fid - demm.
Taking Ziagen with food and drink Ziagen can be taken with food or on an empty stomach.
Meta tieħu Ziagen ma ’ l- ikel u max- xorb Ziagen jista jittieħed ma ’ l- ikel jew fuq stonku vojt.
Pregnancy and breast-feeding Ziagen is not recommended for use during pregnancy.
Tqala u Treddigħ Ziagen m’ huwiex rakkomandat waqt it- tqala.
If you become pregnant, or are planning to become pregnant, you must contact your doctor to discuss the potential adverse effects and the benefits and risks of your antiretroviral therapy to you and your child.
Jekk inti toħrog tqila, jew qed tippjana tqala, għandek tikkuntatja lit- tabib tiegħek biex tiddiskuti l- effetti avversi li jistgħu jiġru u l- benefiċċji u r- riskji tat - terapija antiretrovirali tiegħek għalik u għat- tarbija tiegħek.