qanastek/EMEA-V3 huggingface dataset:
Compared with patients with normal renal function, the mean (%CV) tenofovir exposure increased from 2,185 (12%) ng·h/ ml in subjects with CrCl > 80 ml/ min to respectively 3,064 (30%) ng·h/ ml, 6,009 (42%) ng·h/ ml and 15,985 (45%) ng·h/ ml in patients with mild, moderate and severe renal impairment.
Meta mqabbel ma ’ pazjenti b’ funzjoni renali normali, l- esponiment medju tat- tenofovir (% CV) żdiedet minn 2, 185 (12%) ng· h/ ml f’ individwi b’ CrCl > 80 ml/ min għal 3, 064 (30%) ng· h/ ml, 6, 009 (42%) ng· h/ ml u 15, 985 (45%) ng· h/ ml rispettivament f‘ pazjenti b’ indeboliment renali ħafif, moderat u sever.
The dosing recommendations in patients with renal impairment, with increased dosing interval, are expected to result in higher peak plasma concentrations and lower Cmin levels in patients with renal impairment compared with patients with normal renal function.
Ir - rakkomandazzjonijiet għad- dożaġġ f’ pazjenti b’ indeboliment renali bi żieda fl- intervall bejn id- dożaġġ, huma mistennija li jirriżultaw f’ livelli ogħla tal- konċentrazzjonijiet massimi fil- plażma u livelli aktar baxxi ta ’ Cmin f’ pazjenti b’ indeboliment renali meta mqabbla ma ’ pazjenti b’ funzjoni renali normali.
The clinical implications of this are unknown.
L- implikazzjonjiiet kliniċi ta ’ dan m’ humiex magħrufa.
In patients with end-stage renal disease (ESRD) (CrCl < 10 ml/ min) requiring haemodialysis, between dialysis tenofovir concentrations substantially increased over 48 hours achieving a mean Cmax of 1,032 ng/ ml and a mean AUC0-48h of 42,857 ng·h/ ml.
F’ pazjenti b’ mard renali fl- aħħar stadju (ESRD) (CrCl < 10 ml/ min) li jeħtieġu d- dijaliżi tad- demm, bejn is- sessjonijiet tad- dijaliżi, il- konċentrazzjonijiet ta ’ tenofovir żdiedu sostanzjalment fi żmien 48 siegħa u laħqu medja ta ’ Cmax ta ’ 1, 032 ng/ ml u medja ta ’ AUC0- 48h ta ’ 42, 857 ng· h/ ml.
It is recommended that the dosing interval for tenofovir disoproxil 245 mg (as fumarate) is modified in patients with creatinine clearance < 50 ml/ min or in patients who already have ESRD and require dialysis (see section 4.2).
Huwa rrakkomandat li l- intervall bejn id- dożaġġ ta ’ 245 mg tenofovir disoproxil (bħala fumarate) jinbidel f’ pazjenti b’ rata ta ’ tneħħija tal- krejatinina ta ’ < 50 ml/ min jew f’ pazjenti li diġa għandhom ESRD u jeħtieġu d- dijaliżi (ara sezzjoni 4. 2).
The pharmacokinetics of tenofovir in non-haemodialysis patients with creatinine clearance < 10 ml/ min and in patients with ESRD managed by peritoneal or other forms of dialysis have not been studied.
Il- farmakokinetiċi ta ’ tenofovir f’ pazjenti li ma ’ jieħdux id- dijaliżi tad- demm, b’ rata ta ’ tneħħija tal - krejatinina ta ’ < 10 ml/ min, u f’ pazjenti b’ ESRD immaniġġjata minn dijaliżi peritoneali jew xi forom oħra ta ’ dijaliżi ma ġewx studjati.
17 Hepatic impairment A single 245 mg dose of tenofovir disoproxil was administered to non-HIV, non-HBV infected patients with varying degrees of hepatic impairment defined according to Child-Pugh-Turcotte (CPT) classification.
18 Indeboliment epatiku Doża waħda ta ’ 245 mg tenofovir disoproxil ngħatat lill- pazjenti li ma kienux infettati b’ HIV u dawk mhux infettati bl- HBV li kellhom indeboliment epatiku fi stadji differenti skond il- klassifikazzjoni ta ’ Child- Pugh- Turcotte (CPT).
Tenofovir pharmacokinetics were not substantially altered in subjects with hepatic impairment suggesting that no dose adjustment is required in these subjects.
Il- farmakokinetiċi ta ’ tenofovir ma nbidlux sostanzjalment f’ individwi b’ indeboliment epatiku, li jissuġġerixxi li l- ebda aġġustament fid- doża mhuwa meħtieġ f’ dawn l - individwi.
The mean (%CV) tenofovir Cmax and AUC0-∞ values were 223 (34.8%) ng/ ml and 2,050 (50.8%) ng·h/ ml, respectively, in normal subjects compared with 289 (46.0%) ng/ ml and 2,310 (43.5%) ng·h/ ml in subjects with moderate hepatic impairment, and 305 (24.8%) ng/ ml and 2,740 (44.0%) ng·h/ ml in subjects with severe hepatic impairment.
Il- medja (% CV) tal- valuri ta ’ Cmax ta ’ tenofovir u l- valuri ta ’ l- AUC0- ∞ kienu ta ’ 223 (34. 8%) ng/ ml u 2, 050 (50. 8%) ng· h/ ml rispettivament, f’ individwi normali, meta pparagunata ma ’ 289 (46. 0%) ng/ ml u 2, 310 (43. 5%) ng· h/ ml f’ individwi b’ indeboliment epatiku moderat, u 305 (24. 8%) ng/ ml u 2, 740 (44. 0%) ng· h/ ml f’ individwi b’ indeboliment epatiku sever.
Intracellular pharmacokinetics In non-proliferating human peripheral blood mononuclear cells (PBMCs) the half-life of tenofovir diphosphate was found to be approximately 50 hours, whereas the half-life in phytohaemagglutinin- stimulated PBMCs was found to be approximately 10 hours.
Farmakokinetika intraċellulari F ’ ċelluli mononukleari umani tad- demm periferali mhux proliferattivi (PBMCs) il- ħin tenofovir diphosphate jonqos bin- nofs instab li huwa ta ’ madwar 50 siegħa, filwaqt li l- ħin biex il- livell ta ’ PBMCs stimulati minn phytohaemagglutinin jonqos bin- nofs instab li huwa ta ’ madwar 10 sigħat.
Preclinical studies conducted in rats, dogs and monkeys revealed target organ effects in gastrointestinal tract, kidney, bone and a decrease in serum phosphate concentration.
Studji ta ’ qabel l- użu kliniku li saru fil- firien, fil- klieb u fix- xadini wrew effetti fuq l- organi milquta fil- passaġġ gastro- intestinali, fil- kliewi, fil- għadam u tnaqqis fil- konċentrazzjoni ta ’ phosphate fis - serum.
Bone toxicity was diagnosed as osteomalacia (monkeys) and reduced bone mineral density (rats and dogs).
It- tossiċità fl- għadam kienet dijanjostikata bħala osteomalaċja (fix- xadini) u tnaqqis fid- densità minerali ta ’ l- għadam (fil- firien u l- klieb).
Findings in the rat and monkey studies indicated that there was a substance-related decrease in intestinal absorption of phosphate with potential secondary reduction in bone mineral density.
Sejbiet fl- istudji fuq il- firien u x- xadini indikaw li kien hemm tnaqqis konness mas- sustanza fl- assorbiment intestinali ta ’ phosphate b’ potenzjali ta ’ tnaqqis sekondarju fid- densità minerali ta ’ l- għadam.
However, no conclusion could be drawn on the mechanism(s) underlying these toxicities.
Madanakollu, l- ebda konklużjoni ma saret mill - mekkaniżmu( i) li huma l- bażi ta ’ dawn it- tossiċitajiet.
Reproductive studies were conducted in rats and rabbits.
Studji reproduttivi saru fil- firien u fil- fniek.
There were no effects on mating or fertility parameters or on any pregnancy or foetal parameter.
Ma kienx hemm effetti fuq il- parametri tat- tgħammir jew tal- fertilità jew fuq xi parametru tat- tqala jew tal- fetu.
There were no gross foetal alterations of soft or skeletal tissues.
Ma ’ kienx hemm tibdil kbir fit- tessuti rotob jew skeletali tal- fetu.
Tenofovir disoproxil fumarate reduced the viability index and weight of pups in peri- post natal toxicity studies.
Tenofovir disoproxil fumarate naqqas l- indiċi ta ’ vijabilità u l- piż tal- friegħ fi studji tossiċi li saru wara t- twelid.
Genotoxicity studies have shown that tenofovir disoproxil fumarate was negative in the in vivo mouse bone marrow micronucleus assay but was positive for inducing forward mutations in the in vitro L5178Y mouse lymphoma cell assay in the presence or absence of S9 metabolic activation.
Studji ġenotossiċi wrew li tenofovir disoproxil fumarate taw riżultati negattivi fl- analiżi mikronuklejari in vitro tal- mudullun tal- ġurdien iżda ta riżultat pożittiv għall- induzzjoni ’ l quddiem ta ’ mutazzjonijiet fl- analiżi in vitro taċ- ċelluli tal- limfoma tal- ġurdien L5178Y fil- preżenza jew fl- assenza ta ’ l- attivazzjoni metabolika S9.
Tenofovir disoproxil fumarate was positive in the Ames test (strain TA 1535) in two out of three studies, once in the presence of S9 mix (6.2- to 6.8-fold increase) and once without S9 mix.
Tenofovir disoproxil fumarate kien pożittiv fit- test Ames (strejn TA 1535) fi tnejn minn tliet studji, darba fil- preżenza ta ’ taħlita S9 (żieda ta ’ 6. 2 sa 6. 8 darbiet) u darba mingħajr taħlita S9.
Tenofovir disoproxil fumarate was also weakly positive in an in vivo / in vitro unscheduled DNA synthesis test in primary rat hepatocytes.
Tenofovir disoproxil fumarate kien ukoll pożittiv b’ mod dgħajjef f’ testijiet in vivo / in vitro tas- sintesi ta ’ DNA mhux skedat f’ epatoċiti primarji tal- far.
Tenofovir disoproxil fumarate did not show any carcinogenic potential in a long-term oral carcinogenicity study in rats.
Tenofovir disoproxil fumarate ma wera l- ebda riskju ta ’ kanċer fi studju karċinoġeniku fuq il- firien bl - użu orali fit- tul.
A long-term oral carcinogenicity study in mice showed a low incidence of duodenal tumours, considered likely related to high local concentrations of tenofovir disoproxil fumarate in the gastrointestinal tract at a dose of 600 mg/ kg/ day.
Studju fit- tul dwar il- karċinoġeniċità fil- ġrieden wera inċidenza baxxa ta ’ tumuri tad - duwodenu, li kienu kkunsidrati li x’ aktarx kienu relatati mal- konċentrazzjonijiet għolja ta ’ tenofovir disoproxil fumarate fil- passaġġ gastro- intestinal f’ doża ta ’ 600 mg/ kg kuljum.
While the mechanism of tumour formation is uncertain, the findings are unlikely to be of relevance to humans.
Għalkemm il - mekkaniżmu tal- formazzjoni tat- tumuri mhuwiex ċar, dawn is- sejbiet m’ humiex mistennija li jkunu rilevanti għall- bniedem.
Microcrystalline cellulose (E460) Pregelatinised starch (gluten free) Croscarmellose sodium Lactose monohydrate Magnesium stearate (E572)
Microcrystalline cellulose (E460) Pregelatinised starch (gluten free) Croscarmellose sodium Lactose monohydrate Magnesium stearate (E572)
18 Coating:
19 Miksi:
Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Glycerol triacetate (E1518) Indigo carmine aluminium lake (E132)
Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Glycerol triacetate (E1518) Indigo carmine aluminium lake (E132)
Viread is supplied in high density polyethylene (HDPE) bottles with a child-resistant closure containing 30 film-coated tablets with a silica gel desiccant.
Viread huwa fornut f’ fliexken ta ’ densità għolja tal- polythene (HDPE) b’ għatu li ma jinfetaħx mit- tfal li fihom 30 pillola miksija b’ rita u ġel dessikant tas- silika.
The following pack sizes are available: outer cartons containing 1 x 30 film-coated tablet and 3 x 30 film-coated tablet bottles.
Id- daqsijiet tal- pakketti li ġejjin huma disponibbli: kartun ta ’ barra li fihom fliexkun ta ’ 30 pillola miksija b’ rita u kartun ta ’ barra li fihom 3 fliexken ta ’ 30 pillola miksija b’ rita.
5 February 2002 Date of last renewal:
5 ta ’ Frar 2002 Data ta ’ l- aħħar tiġdid ta ’ l- awtorizzazzjoni:
7 February 2007
7 ta ’ Frar 2007
19 Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /.
Names and addresses of the manufacturers responsible for batch release
KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ
Nycomed Oranienburg GmbH Lehnitzstrasse 70-98 D-16515 Oranienburg Germany
Nycomed Oranienburg GmbH Lehnitzstrasse 70- 98 D- 16515 Oranienburg Il- Ġermanja
The MAH must ensure that the system of pharmacovigilance, as described in version 1.0 (24/ 05/ 2007) and included in the Type II variation EMEA/ H/ C/ 419/ II/ 075 and subsequent updates, is in place and functioning before and whilst the product is on the market.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni 1. 0 (24/ 05/ 2007) u inkluża fil- varjazzjoni Tip II EMEA/ H/ C/ 419/ II/ 075 u l - aġġornamenti sussegwenti, tkun fis- seħħ u li din tkun qed taħdem sewwa qabel u filwaqt li l- prodott ikun fis- suq.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3.0 of the Risk Management Plan (RMP) presented in response to questions as part of procedure EMEA/ H/ C/ 419/ II/ 075 and any subsequent updates of the RMP agreed by the CHMP.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq iwiegħed li jwettaq l- istudji u l- attivitajiet ta ’ farmakoviġilanza addizzjonali deskritti fid- dettall fil- Pjan ta ’ Farmakoviġilanza, kif hemm qbil fuqu fil- verżjoni 3. 0 tal- Pjan ta ’ Maniġġar tar- Riskji (RMP) ippreżentat bħala rispons għall- mistoqsijiet bħala parti mill- proċedura EMEA/ H/ C/ 419/ II/ 075 u kwalunkwe aġġornamenti sussegwenti tal- RMP li jkun sar qbil fuqhom mill- CHMP.
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).
23 Skond il- Linja gwida tal- CHMP dwar is- Sistemi ta ’ Maniġġar tar- Riskji għal prodotti mediċinali għall- użu mill- bniedem, l- RMP aġġornat għandu jiġi ppreżentat fl- istess ħin tar- Rapport ta ’ Aġġornament tas- Sigurtà Perjodika li jmiss (PSUR).
22 In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Barra minn hekk, għandu jiġi ppreżentat RMP aġġornat • Meta tiġi rċevuta informazzjoni ġdida li jista ’ jkollha impatt fuq l- Ispeċifikazzjoni tas- Sigurtà attwali, il- Pjan ta ’ Farmakoviġilanza jew l- attivitajiet ta ’ tnaqqis tar- riskji • Fi żmien 60 jum minn meta tintlaħaq mira importanti (farmakoviġilanza jew tnaqqis tar- riskji) • Fuq talba ta ’ l- EMEA
25 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
TIKKETTA
CARTON AND BOTTLE LABEL TEXT
IL- KITBA TA ’ FUQ IL- KARTUNA U T- TIKKETTA TAL- FLIXKUN
Viread 245 mg film-coated tablets Tenofovir disoproxil
Viread 245 mg pilloli miksija b’ rita Tenofovir disoproxil
Each film-coated tablet contains 245 mg tenofovir disoproxil equivalent to 300 mg tenofovir disoproxil fumarate.
Kull pillola miksija b’ rita fiha 245 mg tenofovir disoproxil ekwivalenti għal 300 mg tenofovir disoproxil fumarate.
EU/ 1/ 01/ 200/ 001 30 film-coated tablets EU/ 1/ 01/ 200/ 002 3 x 30 film-coated tablets
EU/ 1/ 01/ 200/ 001 30 pillola miksija b’ rita EU/ 1/ 01/ 200/ 002 3 x 30 pillola miksija b’ rita
Viread [outer packaging only]
Viread [pakkett ta ’ barra biss]
What Viread is and what it is used for 2.
X’ inhu Viread u għalxiex jintuża 2.
Before you take Viread 3.
Qabel ma tieħu Viread 3.
How to take Viread 4.
Kif għandek tieħu Viread 4.
How to store Viread 6.
Kif taħżen Viread 6.
WHAT VIREAD IS AND WHAT IT IS USED FOR
X’ INHU VIREAD U GĦALXIEX JINTUŻA
Viread is a treatment for Human Immunodeficiency Virus (HIV) infection in adults over 18 years of age.
Viread hu trattament għal Virus ta ’ l- Immunodefiċjenza Umana (HIV) fl- adulti li għandhom iktar minn 18- il sena.
Viread is also used to treat chronic hepatitis B, an infection with hepatitis B virus (HBV), in adults.
Viread jintuża wkoll biex jittratta l- epatite B kronika, infezzjoni bil- virus ta ’ l- epatite B (HBV), fl- adulti.
You do not have to have HIV to be treated with Viread for HBV.
Mhux bilfors irid ikollok l- HIV biex tkun ittrattat/ a b’ Viread għall- HBV.
Viread contains the active substance tenofovir disoproxil.
Viread fih s- sustanza attiva tenofovir disoproxil.
This active substance is an antiretroviral or antiviral medicine which is used to treat HIV or HBV or both.
Din is- sustanza attiva hi mediċina antiretrovirali jew antivirali li tintuża biex tittratta l- infezzjoni ta ’ l- HIV jew ta ’ l- HBV jew it- tnejn.
DNA polymerase) that are essential for the viruses to reproduce themselves.
Tenofovir hu impeditur tan- nukleotide reverse transcriptase; ġeneralment magħruf bħala NRTI u jaħdem billi jinterferixxi mal- ħidma normali ta ’ l- enzimi (fl- HIV: reverse transcriptase; fl- epatite B: polymerase tad- DNA) li huma essenzjali biex il- viruses jirriproduċu lilhom infushom.
In HIV Viread should always be used combined with other medicines to treat HIV infection.
Fl- HIV Viread għandu dejjem jintuża ma ’ mediċini oħrajn biex jittratta infezzjoni bl- HIV.
While taking Viread you may still develop infections or other illnesses associated with HIV infection.
Waqt li tkun qed tieħu Viread inti xorta waħda tista ’ tiżviluppa infezzjonijiet u mard ieħor marbut ma ’ l- infezzjoni ta ’ l- HIV.
You can also pass on HIV or HBV to others, so it is important to take precautions to avoid infecting other people.
Tista ’ wkoll tgħaddi l- HIV jew l- HBV lill- oħrajn, u għalhekk hu important li tieħu prekawzjonijiet biex ma tinfettax nies oħrajn.
BEFORE YOU TAKE VIREAD
QABEL MA TIEĦU VIREAD
Do not take Viread • If you are allergic (hypersensitive) to tenofovir, tenofovir disoproxil fumarate or any of the other ingredients of Viread listed at the end of this leaflet.
Tieħux Viread • Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal tenofovir, tenofovir disoproxil fumarate, jew sustanzi oħra ta ’ Viread elenkati fl- aħħar ta ’ dan il- fuljett.
If this applies to you, tell your doctor immediately and don’ t take Viread.
Jekk dan japplika għalik, għid lit- tabib tiegħek immedjatament u tiħux Viread.
29 Take special care with Viread
30 Oqgħod attent ħafna b’ Viread
• Tell your doctor if you have had kidney disease or if tests have shown problems with your kidneys.
• Għid lit- tabib tiegħek jekk inti kellek mard fil- kliewi jew jekk it- testijiet urew li hemm problemi fil- kliewi tiegħek.
Viread may affect your kidneys.
Viread jista ’ jaffettwa l- kliewi tiegħek.
Before starting treatment, your doctor may order blood tests to check your kidney function and may advise you to take the tablets less often.
Qabel tibda t- trattament, it - tabib tiegħek jista ’ jordna testijiet tad- demm biex jiċċekkja l- funzjoni tal- kliewi tiegħek u jista ’ jagħtik parir biex tieħu l- pilloli inqas ta ’ spiss.
Viread is not usually taken with other medicines that can damage your kidneys (see Taking other medicines).
Viread normalment ma titteħidx ma ’ mediċini oħra li jistgħu jagħmlu ħsara lill- kliewi tiegħek (ara Meta tieħu mediċini oħra).
If this is unavoidable, your doctor will monitor your kidney function once a week.
Jekk dan ma jkunx jista ’ jiġi evitat, it- tabib tiegħek ser jimmonitorja l- funzjoni tal- kliewi tiegħek darba f’ ġimgħa.
Viread has not been studied in patients over 65 years of age.
Viread ma ġiex studjat f’ pazjenti li għandhom iktar minn 65 sena.
If you are older than this and are prescribed Viread, your doctor will monitor you carefully.
Jekk għandek iktar minn 65 sena u tingħata riċetta għal Viread, it- tabib tiegħek ser jimmonitorjak b’ attenzjoni.
• Do not give Viread to children and adolescents under 18 years of age.
• Tagħtix Viread lit- tfal u adolexxenti taħt it- 18 il- sena.
Patients with liver disease including chronic hepatitis B or C, who are treated with antiretrovirals, have a higher risk of severe and potentially fatal liver complications.
Pazjenti b’ mard fil- fwied li jinkludu epatite B jew Ċ kronika, li huma ttrattati bl - antitretrovirali, għandhom riskju ogħla ta ’ kumplikazzjonijiet serji tal- fwied li potenzjalment jistgħu ikunu fatali.
If you have hepatitis B infection, your doctor will carefully consider the best treatment for you.
Jekk għandek infezzjoni ta ’ l- epatite B, it- tabib tiegħek ser jikkunsidra b’ attenzjoni l- aħjar trattament għalik.
If you have a history of liver disease or chronic hepatitis B infection your doctor may conduct blood tests to monitor your liver function.
Jekk għandek passat mediku ta ’ mard tal- fwied jew infezzjoni kronika bl- epatite B, it- tabib tiegħek jista ’ jagħmillek testijiet tad- demm biex jimmonitorja l- funzjoni tal- fwied tiegħek.
Look out for possible signs of lactic acidosis (excess of lactic acid in your blood) once you start taking Viread.
Oqgħod attent/ a għal sinjali possibbli ta ’ aċidożi lattika (ammont żejjed ta ’ aċidu lattiku fid - demm tiegħek) ġaladarba tibda tieħu Viread.
Possible signs of lactic acidosis are:
Sinjali possibbli ta ’ aċidożi lattika huma:
deep, rapid breathing drowsiness nausea, vomiting and stomach pain
nifs qawwi u mgħaġġel telqa tqalligħ, rimettar u uġigħ ta ’ l- addome
• This rare but serious side effect can cause enlargement of the liver and has occasionally been fatal.
L -
Lactic acidosis occurs more often in women, particularly if they are very overweight.
aċidożi lattika sseħħ iżjed spiss fin- nisa partikularment jekk ikunu ħoxnin ħafna.
While you are being treated with Viread, your doctor will monitor you closely for any signs that you may be developing lactic acidosis.
Waqt li tkun qed tieħu l- Viread, it- tabib tiegħek ser jeżaminak mill- qrib għal xi sinjali li jindikaw li tkun qed tiżviluppa l- aċidożi lattika.
• Take care not to infect other people.
• Oqgħod attent/ a li ma tinfettax persuni oħrajn.
Viread does not reduce the risk of passing on HIV or HBV to others through sexual contact or blood contamination.
Viread ma jnaqqasx ir- riskju li tgħaddi l- HIV jew l- HBV lill- ħaddieħor permezz ta ’ kuntatt sesswali jew tniġġiż tad- demm.
You must continue to take precautions to avoid this.
Għandek tkompli tieħu l- prekawzjonijiet biex tevita li dan iseħħ.
In the treatment of HIV, combination antiretroviral therapies (including Viread) may raise blood sugar, increase blood fats (hyperlipaemia), cause changes to body fat, and resistance to insulin (see section 4, Possible side effects).
Fil- kura ta ’ l- HIV, terapiji antiretrovirali kombinati (li jinkludu Viread) jistgħu jgħollu l- livell taz - zokkor fid- demm, ix- xaħmijiet fid- demm (iperlipimja), jikkawżaw tibdil fix- xaħam tal- ġisem, u reżistenza għall- insulina (ara sezzjoni 4, Effetti sekondarji li jista ’ jkollu).
If you have advanced HIV infection (AIDS) and have an infection, you may develop symptoms of infection and inflammation or worsening of the symptoms of an existing infection once treatment with Viread is started.
Jekk għandek infezzjoni avvanzata ta ’ l- HIV (AIDS) u għandek infezzjoni, inti tista ’ tiżviluppa sintomi ta ’ infezzjoni u infjammazzjoni jew is- sintomi ta ’ infezzjoni eżistenti jistgħu imorru għall- agħar ġaladarba jinbeda t- trattament b’ Viread.
These symptoms may indicate that your body’s improved immune system is fighting infection.
Dawn is - sintomi jistgħu jindikaw li s- sistema immuni mtejba ta ’ ġismek qed tiġġieled lill- infezzjoni.
Look out for signs of inflammation or infection soon after you start taking Viread.
Oqgħod attent/ a għal sinjali ta ’ infjammazzjoni jew infezzjoni malli tibda tieħu Viread.
30 Bone problems.
31 Problemi fl- għadam.
Some patients with HIV 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 bl- HIV li jkunu qed jieħdu terapija antiretrovirali kombinata jistgħu jiżviluppaw marda ta ’ l- għadam imsejħa osteonekrożi (il- mewt tat- tessut ta ’ l- għadam ikkawżata minn telf tal- provvista tad- demm lill- għadam).
Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Sinjali ta ’ osteonekrożi huma: ebusija tal- ġogi, uġigħ (speċjalment fl- għadam tal- ġenbejn, l- irkopptejn u l- ispallejn) u diffikultà fiċ- ċaqliq.
If you notice any of these symptoms tell your doctor.
Jekk tinnota xi sintomu minn dawn, għid lit- tabib tiegħek.
Do not take Viread if you are already taking other medicines containing tenofovir disoproxil fumarate.
M’ għandekx tieħu Viread jekk diġà qed tieħu mediċini oħrajn li fihom tenofovir disoproxil fumarate.
Do not take Viread and Hepsera (adefovir dipivoxil) at the same time.
Tiħux Viread u Hepsera (adefovir dipivoxil) fl- istess ħin.
• It is very important to tell your doctor if you are taking other medicines that may damage your kidneys.
• Hu importanti ħafna li tgħid lit- tabib tiegħek jekk qed tieħu mediċini oħra li jistgħu jagħmlu ħsara lill- kliewi tiegħek.
aminoglycosides, pentamidine or vancomycin (for bacterial infection) amphotericin B (for fungal infection) foscarnet, ganciclovir, or cidofovir (for viral infection) interleukin-2 (to treat cancer) adefovir dipivoxil (for HBV) tacrolimus (for suppression of the immune system)
aminoglycosides, pentamidine jew vancomycin (għal infezzjoni batterjali) amphotericin B (għal infezzjoni fungali) foscarnet, ganciclovir jew cidofovir (għal infezzjoni virali) interleukin- 2 (għat- trattament tal- kanċer) adefovir dipivoxil (għal HBV) tacrolimus (għat- trażżin tas- sistema immuni)
Taking Viread with other
• Mediċini oħra li fihom didanosine (għall- infezzjoni bl- HIV):
antiviral medicines that contain didanosine can raise the levels of didanosine in your blood and may reduce CD4 cell counts.
Li tieħu Viread ma ’ mediċini antivirali oħra li fihom didanosine jista ’ jgħolli l- livelli ta ’ didanosine fid- demm tiegħek u jista ’ jnaqqas l- għadd taċ- ċelluli CD4 tiegħek.
Rarely, inflammation of the pancreas and lactic acidosis (excess lactic acid in the blood), which sometimes caused death, have been reported when medicines containing tenofovir disoproxil fumarate and didanosine were taken together.
F’ każijiet rari, infjammazzjoni tal- frixa u aċidożi lattika (ammont żejjed ta ’ aċidu lattiku fid- demm), li xi kultant wasslet għall- mewt, kienu rrappurtati meta mediċini li fihom tenofovir disoproxil fumarate u didanosine ttieħdu flimkien.
Your doctor will carefully consider whether to treat you with combinations of tenofovir and didanosine.
It- tabib tiegħek ikollu jikkunsidra b’ attenzjoni jekk jagħtikx trattament mħallat ta ’ tenofovir u didanosine.
• Don’t stop any anti-HIV medicines prescribed by your doctor when you start Viread if you have both HBV and HIV.
• Twaqqaf l- ebda mediċini kontra l- HIV li jkun tak riċetta għalihom it- tabib tiegħek meta tibda tieħu Viread jekk għandek kemm l- HBV kif ukoll l- HIV.
Taking Viread with food and drink
Meta tieħu Viread ma ’ l- ikel u max- xorb
• Take Viread with food (for example, a meal or a snack).
• Ħu Viread ma ’ l- ikel (per eżempju, ma ’ ikla jew ma ’ ikla ħafifa).
• You must not take Viread during pregnancy unless specifically discussed with your doctor.
• M’ għandekx tieħu Viread matul it- tqala ħlief jekk tkun iddiskutejt dan speċifikament mat - tabib tiegħek.
There are no clinical data on the use of Viread in pregnant women and it is not usually used unless absolutely necessary.
M’ hemmx dejta klinika dwar l- użu ta ’ Viread f’ nisa tqal u dan normalment ma jintużax jekk mhux assolutament meħtieġ.
• Try to avoid getting pregnant during treatment with Viread.
• Ipprova tinqabadx tqila matul it- trattament b’ Viread.
You must use an effective method of contraception to avoid becoming pregnant.
Għandek tuża metodu effettiv ta ’ kontraċezzjoni sabiex tevita li toħroġ tqila.
31 • If you become pregnant, or plan to become pregnant, ask your doctor about the potential benefits and risks of your antiretroviral therapy to you and your child.
32 • Jekk toħroġ tqila, jew qed tippjana biex toħroġ tqila, staqsi lit- tabib tiegħek dwar il- benefiċċji u r- riskji potenzjali tat- terapija antiretrovirali tiegħek, għalik u għat- tarbija tiegħek.
• If you have taken Viread during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
• Jekk ħadt Viread waqt it- tqala, it- tabib jista ’ jagħmillek testijiet regolari tad- demm u testijiet dijanjostiċi oħra biex jimmonitorja l- iżvilupp tat- tarbija tiegħek.
In children whose mothers took medicines like Viread (NRTIs) during pregnancy, the benefit from the protection against the virus outweighed the risk of side effects.
Fi tfal li ommhom ħadet mediċini bħal Viread (NRTIs) waqt it- tqala, il- benefiċċju mill- protezzjoni kontra l- virus kien ikbar mir- riskju ta ’ l- effetti sekondarji.
• Do not breast-feed during treatment with Viread.
• M’ għandekx tredda ’ matul it- trattament b’ Viread.
It is not yet known whether the active substance in this medicine passes into human breast milk.
Għadu mhux magħruf jekk is- sustanza attiva f’ din il- mediċina tgħaddhiex ġol- ħalib tas- sider uman.
• If you are a woman with HIV or HBV do not breast-feed, to avoid passing the virus to the baby in breast milk.
• Jekk inti mara li għandek l- HIV jew l- HBV, treddgħax, biex tevita li tgħaddi l- virus lit- tarbija mill- ħalib tas- sider.
Driving and using machines Viread can cause dizziness.
Sewqan u tħaddim ta ’ magni Viread jista ’ jikkawża sturdament.
If you feel dizzy while taking Viread, do not drive and do not use any tools or machines.
Jekk tħossok stordut/ a meta tieħu Viread, m’ għandekx issuq jew tagħmel użu minn għodda jew tħaddem magni.
Important information about some of the ingredients of Viread
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Viread
Viread contains lactose.
Viread fih lactose.
Tell your doctor before taking Viread if you cannot tolerate lactose or if you have an intolerance to any other sugars.
Għid it- tabib tiegħek qabel ma tieħu Viread jekk ma tittollerax il- lactose jew jekk għandek intolleranza għal ċerti tipi ta ’ zokkor.
HOW TO TAKE VIREAD
KIF GĦANDEK TIEĦU VIREAD
• Always take Viread exactly as your doctor has told you.
• Dejjem għandek tieħu Viread preċiżament skond il- parir tat- tabib.
The usual dose: • Adults: one tablet each day with food (for example, a meal or a snack). • Not for children and adolescents (under 18 years of age).
Id- doża li ssoltu tingħata: • Adulti: pillola waħda kuljum ma ’ l- ikel (per eżempju, ikla jew ikla ħafifa). • Mhux għat- tfal u adolexxenti (taħt it- 18 il- sena).
If you have particular difficulty swallowing, you can use the tip of a spoon to crush the tablet.
Jekk ikollok xi diffikultà partikulari biex tibla ’, tista ’ tuża t- tarf ta ’ mgħarfa biex tfarrak il- pillola.
Then mix the powder with about 100 ml (half a glass) of water, orange juice or grape juice and drink immediately.
Imbagħad ħallat it- trab f’ madwar 100 ml (nofs tazza) ilma, meraq tal- larinġ jew meraq ta ’ l- għeneb u ixrob immedjatament.
• If you have problems with your kidneys, your doctor may advise you to take Viread less frequently.
• Jekk għandek problemi bil- kliewi, it- tabib tiegħek jista ’ jagħtik parir biex tieħu Viread inqas ta ’ sikwit.
• If you have HBV your doctor may offer you an HIV test to see if you have both HBV and HIV.
• Jekk għandek l- HBV, it- tabib tiegħek jista ’ joffri li jagħmillek test ta ’ l- HIV biex jara jekk għandekx l- HBV kif ukoll l- HIV.
If you take more Viread than you should
33 Jekk tieħu aktar Viread milli suppost
If you accidentally take too many Viread tablets, contact your doctor or nearest emergency department for advice.
Jekk aċċidentalment tieħu pilloli żejda ta ’ Viread, ikkuntattja lit- tabib tiegħek jew l- eqreb dipartiment ta ’ l- emerġenza għal parir.
32 If you forget to take Viread
Jekk tinsa tieħu Viread
It is important not to miss a dose of Viread.
Huwa importanti li ma tinsa tieħu ebda doża ta ’ Viread.
If you miss a dose of Viread, take it as soon as you can, and then take your next dose at its regular time.
Jekk tinsa tieħu doża ta ’ Viread, ħudha malli tkun tista ’, imbagħad ħu d- doża li jmiss fil- ħin regolari tagħha.
If you throw up less than 1 hour after taking Viread, take another tablet.
Jekk tirremetti inqas minn siegħa wara li tkun ħadt Viread, ħu pillola oħra.
You do not need to take another tablet if you were sick more than 1 hour after taking Viread.
M’ hemmx bżonn li tieħu pillola oħra jekk tirremetti iktar minn siegħa wara li tkun ħadt Viread.
If you stop taking Viread
Jekk tieqaf tieħu Viread
• Don’t stop taking Viread without your doctor’s advice.
• Tieqafx tieħu Viread mingħajr il- parir tat- tabib tiegħek.
Stopping treatment with Viread may reduce the effectiveness of the treatment recommended by your doctor.
It- twaqqif tat- trattament b’ Viread jista jwassal għal tnaqqis fl- effett tat- trattament rakkomandat mit- tabib tiegħek.
Talk to your doctor before you stop taking Viread for any reason, particularly if you are experiencing any side effects or you have another illness.
Kellem lit- tabib tiegħek qabel ma tieqaf tieħu Viread għal kwalunkwe raġuni, partikularment jekk tkun qed iġarrab xi effetti sekondarji jew jekk ikollok xi marda oħra.
Contact your doctor before you restart taking Viread tablets.
Ikkuntattja lit- tabib tiegħek qabel ma terġa ’ tibda tieħu l- pilloli Viread.
• If you have hepatitis B or HIV and hepatitis B together (co-infection), it is very important not to stop your Viread treatment without talking to your doctor first.
• Jekk għandek infezzjoni bl- epatite B jew bl- HIV u epatite B flimkien (ko- infezzjoni), hu importanti ħafna li ma twaqqafx it- trattament tiegħek b’ Viread mingħajr qabel ma tkellem lit - tabib tiegħek.
Some patients have had blood tests or symptoms indicating that their hepatitis has got worse after stopping Viread.
Xi pazjenti kellhom testijiet tad- demm jew sintomi li indikaw li l- epatite tagħhom marret għall- agħar wara li waqfu jieħdu Viread.
You may require blood tests for several months after stopping treatment.
Jista ’ jkun hemm bżonn li jsirulek testijiet tad - demm għal diversi xhur wara li twaqqaf it- trattament.
Like all medicines, Viread can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Viread jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Very common side effects (These can affect at least 10 in every 100 patients)
Effetti sekondarji komuni ħafna (Dawn jistgħu jaffettwaw mill- inqas 10 minn kull 100 pazjent)
• diarrhoea, being sick (vomiting), feeling sick (nausea), dizziness
• dijarea, tibda tirremetti (rimettar), tħossok imdardar (tqalligħ), sturdament
Common side effects (These can affect up to 10 in every 100 patients)
Effetti sekondarji komuni (Dawn jistgħu jaffettwaw sa 10 minn kull 100 pazjent)
• headache, stomach pain, feeling tired, feeling bloated, flatulence
• uġigħ ta ’ ras, uġigħ fl- istonku, tħossok għajjien, tħossok minfuħ, gass fl- istonku
33 Rare side effects (These can affect up to 1 in every 1,000 patients)
34 Effetti sekondarji rari (Dawn jistgħu jaffettwaw sa 1 minn kull 1, 000 pazjent)
• excess lactic acid in the blood (lactic acidosis, a serious side effect that can be fatal).
• aċidu lattiku eċċessiv fid- demm (aċidożi lattika, effett sekondarju serju li jista ’ jkun fatali).
deep rapid breathing drowsiness feeling sick (nausea), being sick (vomiting) and stomach pain
nifs qawwi u mgħaġġel telqa tħossok imdardar (tqalligħ), tibda tirremetti (rimettar) u uġigħ fl- istonku
• pain in the tummy (abdomen) caused by inflammation of the pancreas
• uġigħ fiż- żaqq (addome) ikkawżat minn infjammazzjoni tal- frixa
• rash
• raxx
Very rare side effects (These can affect less than 1 in every 10,000 patients)
Effetti sekondarji rari ħafna (Dawn jistgħu jaffettwaw inqas minn 1 minn kull 10, 000 pazjent)
• pain in the tummy (abdomen) caused by inflammation of the liver
• uġigħ fiż- żaqq (addome) ikkawżat minn infjammazzjoni tal- fwied
You may also experience breakdown of muscle, muscle pain or weakness, softening of the bones (with bone pain and sometimes resulting in fractures), fatty liver, inflammation of the kidney, passing a lot of urine and feeling thirsty.
Jista ’ jkollok ukoll kollass tal- muskoli, uġigħ jew dgħjufija fil- muskoli, irtubija ta ’ l- għadam (b’ uġigħ fl- għadam u li xi kultant jirriżulta fi ksur), fwied li jkun fih ix- xaħam, infjammazzjoni tal- kliewi, tagħmel ħafna awrina u tħossok bil- għatx.
The breakdown of muscle, softening of the bones (with bone pain and sometimes resulting in fractures), muscle pain, muscle weakness and decreases in potassium or phosphate in the blood may occur due to damage to kidney tubule cells.
Il- kollass tal- muskoli, l- irtubija ta ’ l- għadam (b’ uġigħ fl- għadam u li xi kultant tirriżulta fi ksur), uġigħ fil- muskoli, dgħjufija fil- muskoli u tnaqqis fil- potassium jew phosphate fid- demm jistgħu jseħħu minħabba ħsara liċ- ċelluli tubuli tal- kliewi.
In the treatment of HIV, combination antiretroviral therapy (including Viread) may change your body shape, by changing the way body fat is distributed.
Fit- trattament ta ’ l- HIV, it- terapija antiretrovirali kombinata (li tinkludi Viread) tista ’ twassal għal bidliet fil- forma ta ’ ġismek dovuti għall- bidliet fit- tqassim tax- xaħam.
You may lose fat from your legs, arms and face; gain fat around the tummy (abdomen) and internal organs; get larger breasts or fatty lumps on the back of the neck (‘buffalo hump’).
Tista ’ titlef xaħam mir- riġlejn, mid- dirgħajn u mill- wiċċ; tista ’ żżid ix- xaħam fiż- żaqq (addome) u f’ organi interni oħra; tkabbir fis - sider u għoqod ta ’ xaħam fuq wara ta ’ l- għonq (‘ ħotba tal- buflu ’).
In the treatment of HIV, combination antiretroviral therapy may also cause increased fats in the blood (hyperlipaemia) and resistance to insulin.
35 Fit- trattament ta ’ l- HIV, it- terapija antiretrovirali kombinata tista ’ wkoll tikkawża żieda tax- xaħmijiet fid- demm (iperlipimja) u reżistenza għall- insulina.
34 If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib tiegħek.
HOW TO STORE VIREAD
KIF TAĦŻEN VIREAD
Do not use Viread after the expiry date which is stated on the bottle and carton after {EXP}.
Tużax Viread wara d- data ta ’ skadenza li tidher fuq il- flixkun u l- kartuna wara JIS.
What Viread contains
X’ fih Viread
- The active substance is tenofovir.
- Is- sustanza attiva hi tenofovir.
Each Viread tablet contains 245 mg of tenofovir disoproxil
Kull pillola ta ’ Viread fiha 245 mg ta ’ tenofovir disoproxil (fil -
(in the form of 300 mg tenofovir disoproxil fumarate), equivalent to 136 mg of tenofovir.
forma ta ’ 300 mg tenofovir disoproxil fumarate), ekwivalenti għal 136 mg ta ’ tenofovir.
- The other ingredients are microcrystalline cellulose (E460), pregelatinised starch (gluten free),
- Is- sustanzi l- oħra huma microcrystalline cellulose (E460), pregelatinised starch (gluten free),
croscarmellose sodium, lactose monohydrate, and magnesium stearate (E572) which make up the tablet core, and lactose monohydrate, hypromellose (E464), titanium dioxide (E171), glycerol triacetate (E1518) and indigo carmine aluminium lake (E132) which make up the tablet coating.
croscarmellose sodium, lactose monohydrate u magnesium stearate (E572) li jiffurmaw il- qalba tal- pillola, u lactose monohydrate, hypromellose (E464), titanium dioxide (E171), glycerol triacetate (E1518) u indigo carmine aluminium lake (E132) li jiffurmaw il- kisja tal- pillola.
What Viread looks like and contents of the pack
Id- dehra ta ’ Viread u l- kontenuti tal- pakkett
Viread 245 mg film-coated tablets are almond-shaped and light blue in colour.
Il- pilloli miksija b’ rita ta ’ Viread 245 mg huma f’ forma ta ’ lewża u huma ta ’ lewn ċelesti.
The tablets are marked on one side with “GILEAD” and “4331” and on the other side with “300”.
Il- pilloli huma mmarkati fuq naħa waħda b ’ “ GILEAD ” u b ’ “ 4331 ” u fuq in- naħa l- oħra b ’ “ 300 ”.
Viread 245 mg film-coated tablets are supplied in bottles containing 30 tablets.
Il- pilloli miksija b’ rita ta ’ Viread 245 mg huma pprovduti fi fliexken li fihom 30 pillola.
35 or
36 jew
What is Vistide?
X’ inhu Vistide?
Vistide is a concentrate that is made up into a solution for infusion (drip into a vein).
Vistide huwa konċentrat li jitħallat biex isir f’ soluzzjoni għall- infużjoni (dripp fil- vina).
It contains the active substance cidofovir (75 mg/ ml).
Fih is - sustanza attiva cidofovir (75 mg/ ml).
What is Vistide used for?
Għal xiex jintuża Vistide?
Vistide is used to treat cytomegalovirus (CMV) retinitis, a viral infection of the retina (the light- sensitive surface at the back of the eye).
Vistide jintuża fit- trattament tar- retinite minn ċitomegalovirus (CMV), infezzjoni virali tar- retina (il - membrana sensittiva għad- dawl li tiksi l- parti l- aktar ta ’ ġewwa tal- għajn).
This disease can cause loss of vision.
Din il- marda tista ’ twassal għat- telf fil- vista.
Vistide is used in patients with acquired immunodeficiency syndrome (AIDS) who do not have kidney disease.
Vistide jintuża fil- pazjenti bis- sindromu minn immunodefiċjenza akkwiżita (AIDS) li ma jbatux minn mard fil- kliewi.
It should only be used when other medicines are unsuitable.
Din il- mediċina għandha tintuża biss jekk mhuwiex possibbli t - trattament b’ mediċini oħra.
How is Vistide used?
Kif jintuża Vistide?
Treatment with Vistide should be prescribed by a doctor who has experience in the management of human immunodeficiency virus (HIV) infection.
It- terapija b’ Vistide għandha tiġi preskritta minn tabib b’ esperjenza fit- trattament tal- infezzjoni tal - virus tal- immunodefiċjenza umana (HIV).
Before receiving Vistide, the patient’ s kidneys must be checked, as the medicine must not be given to patients with kidney disease.
Qabel ma jingħata Vistide, jeħtieġ li l- kliewi tal- pazjent jiġu kkontrollati, billi l- mediċina ma għandhiex tingħata lill- pazjenti b’ mard renali.
During the ‘ induction’ phase, Vistide is given as a one-hour infusion of 5 mg per kilogram body weight once a week for the first two weeks.
Matul il- fażi ta ’ ‘ induzzjoni ’, jingħatw 5 mg Vistide għal kull kilo tal- piż tal- ġisem permezz ta ’ infużjoni għal siegħa waħda, darba fil- ġimgħa għall- ewwel ġimagħtejn.
Then, during the ‘ maintenance’ phase, it is given once every two weeks.
Imbagħad, fil- fażi ta ’ ‘ manteniment ’, il- mediċina tingħata darba kull ġimagħtejn.
Treatment is continued for as long as recommended in local guidelines on the management of HIV-infected patients.
It- terapija titkompla għat- tul ta ’ żmien rakkomandat mil- linji gwida lokali dwar it- trattament tal- pazjenti b’ infezzjoni mill- HIV.
To reduce the risk of kidney damage, patients must also take another medicine called probenecid (2 g three hours before the infusion, then 1 g two and eight hours after the infusion) and receive an infusion of one litre of saline solution one hour before the infusion of Vistide.
Biex ir- riskju ta ’ ħsara fil- kliewi jitnaqqas, il- pazjenti għandhom jieħdu mediċina oħra wkoll li jisimha probenecid (2 g tliet sigħat qabel l- infużjoni, imbagħad 1 g sagħtejn u tmien sigħat wara l- infużjoni), u jirċievu infużjoni ta ’ litru soluzzjoni salina siegħa qabel l- infużjoni ta ’ Vistide.
Probenecid is used because it prevents cidofovir building up in the kidneys, and saline is used to prevent dehydration.
Il- probenecid jintuża għall- prevenzjoni tal- akkumulu ta ’ cidofovir fil- kliewi, filwaqt li s- soluzzjoni salina sservi biex tipprevjeni d- diżidratazzjoni.
How does Vistide work?
Kif jaħdem Vistide?
It blocks the activity of enzymes called ‘ DNA polymerases ’ in CMV, which the virus uses to produce DNA.
Is- sustanza attiva f’ Vistide, cidofovir, hija mediċina antivirali tal- klassi tal - ‘ analogi nukleosidiċi ’ li timblokka l- attività tal- enzimi li jissejħu ‘ DNA polomerażi ’ fis- CMV, użat mill- virus għall - produzzjoni tad- DNA.
When the virus cannot produce DNA, it cannot reproduce, slowing down the spread of infection.
Meta l- virus ma jkunx jista ’ jipproduċi d- DNA, ma jistax jirriproduċi ruħu u dan inaqqas ir- ritmu tat- tifrix tal- infezzjoni.
How has Vistide been studied?
Kif ġie studjat Vistide?
The effects of Vistide in CMV retinitis in AIDS patients were studied in one treatment study and one maintenance study.
L- effetti ta ’ Vistide fil- pazjenti morda bl- AIDS bir- retinite minn CMV ġew eżaminati minn studju fuq it- trattament u minn studju fuq il- manteniment.
The treatment study compared Vistide with no treatment in 48 patients who had not been treated with any medicine for CMV retinitis before.
L- istudju fuq it- trattament, imwettaq fuq 48 pazjent li ma kinux ġew ittrattati qabel bl- ebda mediċina għar- retinite minn CMV, qabbel l- effetti ta ’ Vistide mal- każijiet li fihom ma kienet ġiet adottata l- ebda terapija.
The maintenance study compared two maintenance doses of Vistide (5 and 3 mg/ kg body weight) in 100 patients who had stopped responding to, or could not receive other medicines for CMV retinitis (ganciclovir or foscarnet).
L- istudju fuq il- manteniment qabbel żewġ dożaġġi ta ’ manteniment ta ’ Vistide (5 u 3 mg/ kg tal- piż tal- ġisem) fuq 100 pazjent li ma baqgħux jirrispondu għal mediċini oħra kontra r- retinite minn CMV (ganciclovir jew foscarnet) jew li ma setgħux jiħduhom.
In both studies, the main measure of effectiveness was the time taken for the disease to get worse.
Fiż- żewġ studji, il- kejl ewlieni tal- effikaċja kien iż- żmien li għadda qabel l - aggravar tal- marda.
What benefit has Vistide shown during the studies?
Liema benefiċċju wera Vistide waqt l- istudji mwettqa?
In the treatment study, Vistide was more effective than no treatment.
Fl- istudju fuq it- trattament, Vistide kien iktar effikaċi meta mqabbel mal- każijiet mingħajr trattament.
It took an average of 120 days for CMV retinitis to get worse in patients receiving Vistide, compared with 22 days in those who did not receive any treatment.
Fil- pazjenti ttrattati b’ Vistide ir- retinite minn CMV aggravat wara medja ta ’ 120 jum, filwaqt li l - pazjenti li ma rċevew l- ebda trattament il- marda aggravat wara 22 jum.
In the maintenance study, the 5-mg/ kg dose was more effective than the 3-mg/ kg dose (115 days and 49 days, respectively).
Fl- istudju fuq il- manteniment id- dożaġġ ta ’ 5 mg/ kg kien iktar effikaċi mid- dożaġġ ta ’ 3 mg/ kg (rispettivament 115 u 49 jum).
What is the risk associated with Vistide?
X’ inhu r- riskju assoċjat ma ’ Vistide?
The most common side effects with Vistide (seen in more than 1 patient in 10) are neutropenia (low white blood cell counts), headache, nausea (feeling sick), vomiting, alopecia (hair loss), rash, proteinuria (protein in the urine), increased blood creatinine levels (a breakdown product of muscles), asthenia (weakness) and fever.
L- effetti sekondarji l- aktar komuni b’ Vistide (li dehru f’ iktar minn pazjent 1 minn 10) kienu newtropenija (għadd baxx ta 'ċelluli tad- demm bojod), uġigħ ta ’ ras, nawżea (dardir), remettar, alopeċja (telf ta ’ xagħar), raxx, proteinurja (preżenza ta ’ proteini fl- awrina), żieda fil- livell tal - kreatinina fid- demm (prodott ta ’ skart tal- muskoli), astenija (debbulizza) u deni.
For the full list of all side effects reported with Vistide, see the Package Leaflet.
Għal- lista sħiħa tal - effetti sekondarji rrappurtati b’ Vistide, ara l- Fuljett ta ’ Tagħrif.
Vistide should not be used in people who may be hypersensitive (allergic) to cidofovir or any of the other ingredients.
Vistide ma għandux jintuża f’ persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal cidofovir jew għal xi sustanza oħra tiegħu.
It should also not be used in patients who have kidney disease or who are taking other medicines that might be harmful to the kidneys, or in patients who cannot take probenecid or other ‘ sulfa-containing’ medicines.
Minbarra dan, ma għandux jintuża fil- pazjenti b’ mard fil- kliewi jew f’ kura b’ mediċini oħra li jistgħu jkunu ta ’ ħsara għall- kliewi, jew fil- pazjenti li ma jistgħux jieħdu probenecid jew mediċini oħra li fihom il- kubrit.
Vistide should not be injected directly into the eye.
Vistide ma għandux jiġi injettat direttament fl- għajn.
Why has Vistide been approved?
Għaliex ġie approvat Vistide?
The Committee for Medicinal Products for Human Use (CHMP) decided that Vistide’ s benefits are greater than its risks for the treatment of CMV retinitis in patients with AIDS and without kidney disease.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Vistide huma ikbar mir- riskji tiegħu fit- trattament tar- retinite minn CMC fil- pazjenti bl- AIDS u mingħajr mard renali.
The Committee recommended that Vistide be given marketing authorisation.
Il- Kumitat irrakkomanda li Vistide jingħata awtorizzazzjoni għat- tqegħid fis - suq.
Other information about Vistide:
Aktar tagħrif dwar Vistide:
The European Commission granted a marketing authorisation valid throughout the European Union for Vistide on 23 April 1997.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq fl- Unjoni Ewropea kollha għal Vistide fit- 23 ta ’ April 1997.
The marketing authorisation was renewed on 23 April 2002 and on 23 April 2007.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet mġedda fit- 23 ta ’ April 2002 u fit- 23 ta ’ April 2007.