qanastek/EMEA-V3 huggingface dataset:
Initial symptoms including nausea and vomiting, shortness of breath, an irregular heartbeat, clouding of urine, lethargy and/ or joint discomfort.
Sintomi fil- bidu jinkludu dardir u rimettar, qtugħ ta 'nifs, taħbit irregolari tal- qalb, tissaħħab l- urina, telqa u/ jew uġigħ ħafif fil- ġogi.
If this does occur, it is most likely to occur at the first dose.
Jekk dan jiġri, jseħħ l- aktar spiss ma 'l- ewwel doża.
Your doctor will take appropriate precautions to minimise the risk of this. • Low blood levels of some substances: — low calcium levels, which may cause muscle cramps, abdominal cramps or spasms — low magnesium levels, which may cause muscle weakness, confusion, "jerky" movements, high blood pressure, irregular heart rhythms and decreased reflexes with severely low blood magnesium levels. — low potassium levels may cause a feeling of weakness — low glucose levels, which may cause nausea, sweating, weakness, faintness, confusion or hallucinations.
It- tabib tiegħek jieħu l- prekawzjonijiet meħtieġa biex inaqqas ir- riskju ta 'dan. • Nuqqas fil- livelli tad- demm ta' xi sustanzi: --- livelli baxxi ta 'kalċju, li jistgħu jikkawżaw bugħawwieġijiet fil- muskoli, bugħawwieġijiet fiż- żaqq jew spażmi --- livelli baxxi ta' manjesju, li jistgħu jikkawżaw indebboliment fil- muskoli, konfużjoni, movimenti "mhux kontrollati", pressjoni għolja tad- demm, ritmi irregolari tal- qalb u indebboliment tar- riflessi meta l- livelli tal- manjesju fid- demm ikunu baxxi ħafna. --- livelli baxxi ta 'potassju li jistgħu jikkawżaw sensazzjoni ta' indebboliment --- livelli baxxi ta 'zokkor li jistgħu jikkawżaw dardir, għaraq, indebboliment, ħass ħażin, konfużjoni u alluċinazzjonijiet.
HOW TO STORE ATRIANCE
KIF TAĦŻEN ATRIANCE
Do not use Atriance after the expiry date which is stated on carton and vial.
Tużax Atriance wara d- data ta ’ skadenza li tidher fuq kartuna u fjala.
This medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali m' għandux bżonn xi kundizzjonijiet speċjali għall- ħażna.
What Atriance contains • The active substance of Atriance is nelarabine.
X’ fih Atriance: • Is- sustanza attiva ta 'Atriance huwa nelarabine.
Each ml of Atriance solution for infusion contains 5 mg of nelarabine.
Kull ml ta 'soluzzjoni għall- infużjoni ta' Atriance fih 5 mg ta 'nelarabine.
• The other ingredients are sodium chloride, water for injections, hydrochloric acid/ sodium hydroxide
• L- ingredjenti l- oħra huma sodium chloride, ilma għall- injezzjonijiet, hydrochloric acid/ sodium hydroxide
What Atriance looks like and contents of the pack Atriance solution for infusion is a clear, colourless solution.
Is- soluzzjoni għall- infużjoni ta 'Atriance hija soluzzjoni ċara mingħajr kulur.
It is provided in clear glass vials with a non-latex containing rubber stopper and sealed with an aluminium cap.
Hija tkun fi fjali bi ħġieġ ċar b' tapp tal- gomma li m' hijiex gommalastika, issiġillat b' għatu ta 'l- aluminju.
Each vial contains 50 ml.
Kull fjala fiha 50 ml.
Atriance is supplied in packs of 6 vials.
Atriance jinbiegħ f' pakketti ta '6 fjali.
Marketing Authorisation Holder Glaxo Group Limited, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom.
Glaxo Group Limited, Berkeley Avenue, Greenford, Middlesex UB6 0NN, Renju Unit.
Manufacturer Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations):
Glaxo Operations UK Limited (fil- kummerċ Glaxo Wellcome Operations):
Harmire Road, Barnard Castle, County Durham DL12 8DT, United Kingdom.
Harmire Road, Barnard Castle, County Durham DL12 8DT, Renju Unit.
33 The following information is intended for medical or healthcare professionals only:
33 It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
INSTRUCTIONS ON HOW TO STORE AND DISPOSE OF ATRIANCE
STRUZZJONIJIET TA 'KIF JINĦAŻEN U JINTREMA ATRIANCE
Storage of Atriance solution for infusion
Kif taħżen is- soluzzjoni għall- infużjoni ta 'Atriance
Atriance is stable for up to 8 hours at up to 30ºC once the vial is opened.
Atriance huwa stabbli sa 8 siegħat f' temperatura ta '30°Ċ la darba l- fjala tkun infetħet.
Instructions for handling and disposal of Atriance
Struzzjonijiet għall- immaniġġjar u r- rimi ta 'Atriance
• Staff should be trained in how to handle and transfer the medicinal product. • Pregnant staff should be excluded from working with this medicinal product. • Personnel handling this medicinal product during handling/ transfer should wear protective clothing including mask, goggles and gloves. • All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
• ---- L- impjegati għandhom jiġu mħarrġa kif jimmaniġġjaw u jittrasferixxu il- prodott mediċinali. • --- Nisa tqal m' għandhomx jitħallew jaħdmu b' dan il- prodott mediċinali. • ---- Impjegati li jimmaniġġjaw dan il- prodott mediċinali waqt immaniġġjar/ tehid minn post għall- ieħor għandhom jilbsu ilbies prottettiv li jinkludi maskri, nuċċali biex jipproteġi l- għajnejn u ngwanti. • --- Kull oġġett li jintuża fit- tehid jew fit- tindif, inklużi ngwanti għandhom jitpoġġew f' basktijiet għar- rimi ta 'skart ta' riskju għoli biex jinħarqu b' temperatura għolja.
Liquid waste may be flushed with large amounts of water. • Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
Skart likwidu għandu jitlaħlaħ b' ħafna ilma. • --- Kuntatt aċċidentali mal- ġilda jew l- għajnejn għandu jiġi ttrattat mill- ewwel b' ħafna ilma.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk teħtieġ iktar tagħrif dwar il- kundizzjoni medika jew it- trattament tiegħek, aqra l- Fuljett ta 'Tagħrif (ukoll parti mill- EPAR) jew kellem lit- tabib jew lill- ispiżjar tiegħek Jekk tixtieq aktar informazzjoni abbażi tar- rakkomandazzjonijiet tas- CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Atripla?
X’ inhu Atripla?
Atripla is a medicine containing three active substances: efavirenz (600 mg), emtricitabine (200 mg) and tenofovir disoproxil (245 mg).
Atripla huwa mediċina li fiha tliet sustanzi attivi: efavirenz (600 mg), emtricitabine (200 mg) u tenofovir disoproxil (245 mg).
It is available as pink, capsule-shaped tablets.
Tiġi bħala pilloli roża, forma ta ’ kapsuli.
What is Atripla used for?
Għal xiex jintuża Atripla?
Atripla is an antiviral medicine.
Atripla huwa mediċina antivirali.
It is used to treat adults infected with human immunodeficiency virus-1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Jintuża fit- trattament ta ’ adulti infettati bil- vajrus tal - immunodefiċjenza umana- 1 (HIV- 1), vajrus li jikkawża s- sindromu tal- immunodefiċjenza akkwistata (AIDS).
It is only used in patients whose levels of HIV in the blood (viral loads) have been below 50 copies/ ml for more than three months on their current HIV treatment combination.
Jintuża biss f’ pazjenti li l- livelli tagħhom ta ’ HIV fid- demm (tagħbijiet virali) ikunu inqas minn 50 kopja/ ml għal iktar minn tliet xhur minn meta jkunu bit- trattament tal- HIV attwali tagħhom.
It must not be used in patients in whom any previous HIV treatment combinations have failed to work or have stopped working.
M’ għandux jintuża minn pazjenti li fuqhom ikunu fallew kombinazzjonijiet preċedenti ta ’ trattamenti għall- HIV.
Patients must be known not to have been infected with HIV that was unlikely to respond to any of the three active substances in Atripla before they started their first HIV treatment combination.
Il- pazjenti m’ għandhomx ikunu infettati bl- HIV bi probabilità li ma jirrispondux għat - trattament minn kwalunkwe mit- tliet sustanzi attivi f’ Atripla qabel ma jkunu bdew l- ewwel kombinazzjoni ta ’ trattament għall- HIV.
How is Atripla used?
Kif jintuża Atripla?
Treatment with Atripla should be started by a doctor who has experience in the management of HIV infection.
It- trattament b’ Atripla għandu jinbeda minn tabib b’ esperjenza fil- ġestjoni ta ’ infezzjoni bl- HIV.
The recommended dose is one tablet once a day, swallowed whole with water.
Id - doża rakkomandata hija ta ’ pillola waħda darba kuljum, li tinbela ’ sħiħa mal- ilma.
It is recommended that Atripla be taken on an empty stomach, preferably at bedtime.
Huwa rrakkomandat li Atripla jittieħed fuq stonku vojt, preferibbilment qabel l- irqad.
Patients should take the medicine regularly and avoid missing doses.
Il- pazjenti għandhom jieħdu l- mediċina regolarment u għandhom joqogħdu attenti li ma jaqbżux xi dożi.
Atripla should be used with caution in elderly patients.
Atripla għandu jintuża b’ kawtela f’ pazjenti anzjani.
Atripla is not recommended for patients who have moderate or severe problems with their kidneys.
Atripla mhuwiex rakkomandat għal pazjenti bi problemi moderati jew gravi fil- kliewi.
Patients who have problems with their liver should be monitored closely for side effects.
Il- pazjenti li jkollhom problemi fil- fwied għandhom ikunu sorveljati bir- reqqa għal xi effetti sekondarji.
If patients need to stop taking efavirenz, emtricitabine or tenofovir disoproxil, or need to take different doses, they will need to take medicines containing efavirenz, emtricitabine or tenofovir disoproxil separately.
Jekk il- pazjenti jkollhom iwaqqfu efavirenz, emtricitabine jew tenofovir disoproxil, jew ikollhom bżonn jieħdu dożi differenti, ikollhom jieħdu mediċini li jkun fihom efavirenz, emtricitabine jew tenofovir disoproxil separatament.
Atripla should not be taken at the same time as other medicines that contain efavirenz, emtricitabine or tenofovir disoproxil, or lamivudine (another antiviral medicine).
Atripla m’ għandux jittieħed fl- istess żmien ma ’ mediċini oħra li fihom efavirenz, emtricitabine jew tenofovir disoproxil, jew lamivudine (mediċina antivirali oħra).
For more information, see the Summary of Product Characteristics (also part of the EPAR).
Għal iktar tagħrif, ara s- Sommarju tal - Karatteristiċi tal- Prodott (ukoll parti mill- EPAR).
How does Atripla work?
Kif jaħdem Atripla?
Atripla contains three active substances: efavirenz, which is a non-nucleoside reverse transcriptase inhibitor (NNRTI); emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘ prodrug ’ of tenofovir, meaning that it is converted into the active substance 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Atripla fih tliet sustanzi attivi: efavirenz, li huwa inibitur non- nukleosidiku tat- transkrittażi inversa (nucleoside reverse transcriptase inhibitor, NNRTIs); emtricitabine, li huwa inibitur nukleosidiku tat - 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. tenofovir in the body.
©European Medicines Agency, 2009 Reproduction is authorised provided the source is acknowledged transkrittażi inversa; u tenofovir disoproxil, li huwa ‘ prodroga ’ ta ’ tenofovir, li jfisser li jinbidel fis - sustanza attiva tenofovir fil- ġisem.
Tenofovir is a nucleotide reverse transcriptase inhibitor.
Tenofovir huwa inibitur non- nukleosidiku tat- transkrittażi inversa.
Both nucleoside and nucleotide reverse transcriptase inhibitors are commonly known as NRTIs.
Kemm l- inibituri nukleosidiċi tat- transkrittażi inverse kif ukoll dawk mukleotidiċi huma magħrufin b’ mod komuni bħala NRTIs.
All three active substances block the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses.
It- tliet sustanzi attivi jimblukkaw l- attività tat- transkrittażi inversa, enzim prodott mill- HIV li jippermettilu jinfetta ċelloli u jipproduċi iktar vajrusis.
Atripla keeps the amount of HIV in the blood at a low level.
Atripla jżomm l- ammont ta ’ HIV fid- demm f’ livell baxx.
It does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Ma jfejjaqx l- infezzjoni tal- HIV jew l- AIDS, iżda jista ’ jittardja l - ħsara lis- sistema immunitarja u l- iżvilupp ta ’ infezzjonijiet u mardiet assoċjati mal- AIDS.
All three active substances are already available in the European Union (EU): efavirenz has been approved as Sustiva and Stocrin since 1999, emtricitabine has been approved as Emtriva since 2003, and tenofovir disoproxil has been approved as Viread since 2002.
It- tliet sustanzi attivi diġà huma disponibbli fl- Unjoni Ewropea (UE): efavirenz ilu approvat bħala Sustiva u Stocrin mill- 1999, emtricitabine ilu approvat bħala Emtriva mill- 2003, u tenofovir disoproxil ilu approvat bħala Viread mill- 2002.
The combination of tenofovir disoproxil and emtricitabine has been approved as Truvada since 2005.
Il- kombinazzjoni ta ’ tenofovir disoproxil u emtricitabine ilha approvata Truvada mill- 2005.
How has Atripla been studied?
Kif ġie studjat Atripla?
The main study of Atripla included 300 patients whose HIV infection was already being successfully treated with various combinations of antiviral medicines.
Fl- istudju ewlieni ta ’ Atripla ħadu sehem 300 pazjent b’ infezzjoni tal- HIV li diġà kienu qed jiġu ttrattati b’ suċċess b’ diversi kombinazzjonijiet ta ’ mediċini antivirali.
The study compared the effectiveness of switching to Atripla tablets, taken on an empty stomach, with that of remaining on the successful HIV treatment combination.
L- istudji qabblu l- effikaċja tal - qlib minn pilloli ta ’ Atripla, meħuda fuq stonku vojt, mal- effikaċja ta ’ meta l- pazjenti jitħallew fuq it - trattament tal- HIV li jkun qed ikollu suċċess.
The main measure of effectiveness was the proportion of patients whose viral loads were below 200 copies/ ml after 48 weeks.
Il- mezz ewlieni tal- kejl tal- effikaċja kien il- proporzjon ta ’ pazjenti li t- tagħbijiet virali tagħhom kienu inqas minn 200 kopja/ ml wara 48 ġimgħa.
The company also looked at the way the combined tablet was absorbed in the body in comparison with the separate medicines.
Il- kumpanija ħarset ukoll lejn il- mod li bih il- pillola kombinata ġiet assorbita fil- ġisem meta mqabbel mat- teħid ta ’ mediċini separati.
What benefit has Atripla shown during the studies?
X’ benefiċċju wera Atripla matul l- istudji?
In the main study, switching to Atripla was as effective as remaining on the previous treatment combination.
Fl- istudju ewlieni, il- qlib minn Atripla kien effikaċi daqs meta l- pazjenti baqgħu jieħdu l - kombinazzjoni ta ’ qabel.
After 48 weeks, 89% of the patients taking Atripla (181 out of 203) and 88% of those remaining on previous treatment (85 out of 97) had viral loads below 200 copies/ ml.
Wara 48 ġimgħa, 89% tal- pazjenti li kienu qegħdin jieħdu Atripla (181 minn 203) u 88% ta ’ dawk li baqgħu fuq it- trattament preċedenti (85 minn 97) kellhom tagħbijiet virali ta ’ inqas minn 200 kopja/ ml,.
The combination tablet was absorbed in the body in the same way as the separate medicines, when they were taken without food.
Il- pillola tal- kombinazzjoni kienet assorbita mill- ġisem bl- istess mod bħall- mediċini separati, meta ttieħdu mingħajr l- ikel.
What is the risk associated with Atripla?
X’ inhu r- riskju assoċjat ma ’ Atripla?
The most common side effect with Atripla (seen in more than 1 patient in 10) is dizziness.
L- iktar effett sekondarju komuni ta ’ Atripla (li deher f’ iktar minn pazjent wieħed minn kull 10) hu l - isturdament.
For the full list of all side effects reported with Atripla, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji rrappurtati ma ’ Atripla, ara l- Fuljett ta ’ Tagħrif.
Atripla should not be used in people who may be hypersensitive (allergic) to efavirenz, emtricitabine, tenofovir disoproxil or any of the other ingredients.
Atripla m’ għandux jintuża f’ persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal efavirenz, emtricitabine, tenofovir disoproxil jew għal xi sustanzi oħra tagħha.
It must not be used in patients with severe liver disease or who are taking any of the following medicines: • terfenadine, astemizole (commonly used to treat allergy symptoms – these medicines may be available without prescription); • cisapride (used to relieve certain stomach problems); • midazolam, triazolam (used to relieve anxiety or difficulty sleeping); • pimozide (used to treat mental illnesses); • bepridil (used to treat angina); • ergot alkaloids such as ergotamine, dihydroergotamine, ergonovine and methylergonovine (used to treat migraine headache); • St John’ s wort (a herbal preparation used to treat depression); • voriconazole (used to treat fungal infections).
M’ għandux jintuża f’ pazjenti b’ mard gravi tal- fwied jew li jkunu qed jieħdu waħda jew aktar minn dawn il- mediċini: • terfenadine, astemizole (użati b’ mod komuni fit- trattament ta ’ sintomi tal- allerġija – dawn il - mediċini jistgħu jinkisbu mingħajr riċetta); • cisapride (użat għal serħan minn ċerti problemi tal- istonku); • midazolam, triazolam (użati għat- trattament tal- ansjetà jew diffikultà fl- irqad); • pimozide (użat fit- trattament ta ’ xi mardiet mentali); • bepridil (użat fit- trattament tal- anġina); • ergot alkaloids bħal ergotamine, dihydroergotamine, ergonovine u methylergonovine (użat għat - trattament ta ’ emigranji); • fexfiex tar- raba ’ (St John’ s Wort - preparazzjoni ta ’ ħxejjex użata fit- trattament tad- depressjoni); • voriconazole (użat fit- trattament ta ’ infezzjonijiet minn fungi).
Caution is also needed when Atripla is taken at the same time as other medicines.
Wieħed irid joqgħod attent meta juża Atripla fi żmien meta jkun qed jieħu mediċini oħra.
See the Package Leaflet for further details.
Ara l- Fuljett ta ’ Tagħrif għal iktar dettalji.
As with other anti-HIV medicines, patients taking Atripla may be at increased risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
L- istess bħal f’ mediċini oħra ta ’ kontra l- HIV, il- pazjenti li jkunu qed jieħdu Atripla jista ’ jkollhom riskju ikbar ta ’ lipodistrofija (tibdiliet fid- distribuzzjoni tax- xaħam fil- ġisem), osteonekrożi (mewt ta ’ tessut tal- għadam) jew sindromu tar- rijattivazzjoni immunitarja (sintomi ta ’ infezzjoni kkawżati minn sistema immunitarja li tkun qed tirkurpra).
Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking Atripla.
Il- pazjenti li jkollhom problemi fil- fwied (inkluż infezzjonijiet bl- epatite B jew Ċ) jista ’ jkollhom riskju elevat ta ’ ħsara fil- fwied meta jieħdu Atripla.
As with other medicines containing NRTIs, Atripla may also cause lactic acidosis (a build-up of lactic acid in the body).
Bħal fil- każ ta ’ mediċini oħra li jkun fihom NRTIs, Atripla jista ’ jwassal ukoll għal aċidożi lattika (akkumulazzjoni ta ’ aċidu lattiku fil- ġisem).
Why has Atripla been approved?
2/ 3 Għaliex ġie approvat Atripla?
The Committee for Medicinal Products for Human Use (CHMP) noted that Atripla needs to be taken on an empty stomach to prevent certain side effects, but that this could result in low tenofovir levels in the blood.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem innota li Atripla jrid jittieħed fuq stonku vojt, iżda dan jista ’ jwassal għal livelli baxxi ta ’ tenofovir fid- demm.
Therefore, the Committee concluded that Atripla could be a convenient ‘ one-tablet once-a- day’ treatment when used to maintain low viral loads in patients already taking HIV treatment, but 2/ 3 there is not enough information to be certain about its effects in patients who have not been treated before.
Għalhekk, il- Kumitat ikkonkluda li Atripla jista ’ jkun konvenjenti bħala trattament b ’ ‘ pillola waħda kuljum ’ meta jintuża biex iżomm tagħbijiet virali baxxi f’ pazjenti li diġà jkunu qed jingħataw trattament għall- HIV, iżda m’ hemmx biżżejjed tagħrif biex wieħed jaċċerta ruħu dwar l- effetti tiegħu f’ pazjenti li ma jkunux ittrattati qabel.
Therefore, the Committee decided that Atripla’ s benefits are greater than its risks for the treatment of HIV-1 infection in adults with virologic suppression to HIV-1 ribonucleic acid (RNA) levels of less than 50 copies/ ml on their current combination antiretroviral therapy for more than three months.
Għalhekk, il- Kumitat iddeċieda li l- benefiċċji ta ’ Atripla huma ikbar mir- riskji tiegħu meta jintuża għat- trattament ta ’ infezzjoni tal- HIV- 1 f’ adulti b’ soppressjoni viroloġika għal livelli tal- Aċidu ribonuklejku (RNA) tal- HIV- 1 ta ’ inqas minn 50 kopja/ ml fuq il- kombinazzjoni attwali tat- terapija antiretrovirali għal iktar minn tliet xhur.
The Committee noted that the demonstration of Atripla’ s benefit is based mainly on 48-week data from a study in patients with stable suppression of HIV on an HIV treatment combination who then switched to Atripla.
Il- Kumitat innota li l- benefiċċji ta ’ Atripla jidhru l- aktar minn dejta ta ’ 48 ġimgħa minn studju f’ pazjenti b’ soppressjoni stabbli tal- HIV fuq trattament tal- HIV kombinat li mbagħad bdew jieħdu Atripla.
There is no information on its effects in patients who have not been treated before or who have been treated with many different anti-HIV medicines in the past.
M’ hemmx tagħrif dwar l- effetti tiegħu f’ pazjenti li ma jkunux ingħataw trattament qabel jew li jkunu ġew ittrattati b’ ħafna modi differenti b’ mediċini ta ’ kontra l- HIV fl- imgħoddi.
There is also no information on using Atripla with other anti-HIV medicines.
Lanqas ma hemm tagħrif fuq l- użu ta ’ Atripla ma ’ mediċini oħra ta ’ kontra l- HIV.
The Committee recommended that Atripla be given marketing authorisation.
Il- Kumitat irrakkomanda li Atripla jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Which measures are being taken to ensure the safe use of Atripla?
X’ miżuri qed jittieħdu biex ikun żgurat l- użu sigur ta ’ Atripla?
The company that makes Atripla will make sure that the medicine is used safely, bearing in mind concerns over possible effects of tenofovir disoproxil on the kidneys.
Il- kumpanija li tipproduċi Atripla se tassigura ruħha li l- mediċina tintuża b’ sigurtà, waqt li żżomm f’ moħħha t- tħassib dwar l- effetti possibbli ta ’ tenofovir disproxil fuq il- kliewi.
Other information about Atripla:
Tagħrif ieħor dwar Atripla:
The European Commission granted a marketing authorisation valid throughout the EU for Atripla to Bristol-Myers Squibb And Gilead Sciences Limited on 13 December 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- UE kollha għal Atripla lil Bristol- Myers Squibb And Gilead Sciences Limited fit- 13 ta ’ Diċembru 2007.
The full EPAR for Atripla can be found here.
L- EPAR sħiħ għal Atripla jista ’ jiġi kkonsultat hawn.
EU number EU/ 1/ 07/ 430/ 001
Numru ta ’ l- EU EU/ 1/ 07/ 430/ 001 EU/ 1/ 07/ 430/ 002
Invented name Atripla
Isem inventat Atripla Atripla
Strength 600 mg/ 200 mg/ 245 mg *
Qawwa 600 mg/ 200 mg/ 245 mg * 600 mg/ 200 mg/ 245 mg *
Pharmaceutical Form Film-coated tablet
Għamla farmaċewtika Pillola miksija b’ rita Pillola miksija b’ rita
Package size 30 film-coated tablets
Mnejn jingħata Użu orali Użu orali
Bottle (HDPE/ alu)
Il- pakkett Flixkun (HDPE/ alu) Flixkun (HDPE/ alu)
3 x 30 film-coated tablets
Daqs tal- pakkett 30 pillola miksija b’ rita 3 x 30 pillola miksija b’ rita
* efavirenz / emtricitabine / tenofovir disoproxil (as fumarate)
* efavirenz / emtricitabine / tenofovir disoproxil (bħala fumarate)
Atripla 600 mg/ 200 mg/ 245 mg film-coated tablets
Atripla 600 mg/ 200 mg/ 245 mg pilloli miksijin b’ rita
Each film-coated tablet contains 600 mg of efavirenz, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (as fumarate).
Kull pillola miksija b’ rita fiha 600 mg ta ’ efavirenz, 200 mg ta ’ emtricitabine u 245 mg ta ’ tenofovir disoproxil (bħala fumarate).
Each film-coated tablet contains 1 mmol (23.6 mg) of sodium.
Kull pillola miksija b’ rita fiha 1 mmol (23. 6 mg) ta ’ sodju.
Pink, capsule shaped, film-coated tablet, debossed with “ 123” on one side, plain on the other side.
Pillola roża miksija b’ rita, forma ta ’ kapsula, b ’ “ 123 ” inċiż fuq naħa waħda, sempliċi fuq in- naħa l - oħra.
Atripla is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil fumarate.
Atripla hija kumbinazzjoni ta ’ doża- fissa ta ’ efavirenz, emtricitabine u tenofovir disoproxil fumarate.
It is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults with virologic suppression to HIV-1 RNA levels of < 50 copies/ ml on their current combination antiretroviral therapy for more than three months.
Hija indikata għat- trattament ta ’ infezzjoni bil- virus- 1 ta ’ l- immunodefiċjenza tal- bniedem (HIV- 1) f’ adulti b’ soppressjoni viroloġika għal livelli HIV- 1 RNA ta ’ < 50 kopja/ ml fuq it- terapija antiretrovirali tagħhom ta ’ kombinazzjoni għal aktar minn tliet xhur.
Patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in Atripla prior to initiation of their first antiretroviral treatment regimen (see sections 4.4 and 5.1).
Il- pazjenti ma jridux ikunu esperjenzaw falliment viroloġiku fuq xi terapija antiretrovirali preċedenti u jrid ikun magħruf li ma kellhomx forom tal- virus b’ mutazzjonijiet li jagħtu reżistenza sinifikanti għal xi wieħed mit- tliet komponenti kontenuti f’ Atripla qabel ma jinbeda l- ewwel reġim ta ’ trattament antiretrovirali tagħhom (ara sezzjoni 4. 4 u 5. 1).
The demonstration of the benefit of Atripla is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to Atripla (see section 5.1).
Il- wiri tal- benefiċċju ta ’ Atripla huwa bbażat primarjament fuq dejta ta ’ 48 ġimgħa minn studju kliniku li fih il- pazjenti b’ soppressjoni viroloġika stabbli fuq terapija antiretrovirali ta ’ kombinazzjoni bidlu għal Atripla (ara sezzjoni 5. 1).
No data are currently available from clinical studies with Atripla in treatment-naïve or in heavily pretreated patients.
Ebda dejta ma hija disponibbli bħalissa minn studji kliniċi b’ Atripla fuq pazjenti li qatt ma ppruvaw it- trattament qabel jew f’ pazjenti li ngħataw trattament qawwi qabel.
No data are available to support the combination of Atripla and other antiretroviral agents.
Ebda dejta ma hija disponibbli biex tappoġġja l- kumbinazzjoni ta ’ Atripla u mediċini antiretrovirali oħra.
4.2 Posology and method of administration
4. 2 Pożoloġija u metodu ta ’ kif għandha tingħata
Therapy should be initiated by a physician experienced in the management of human immunodeficiency virus (HIV) infection.
It- terapija għandha tinbeda minn tabib esperjenzat fl- immaniġġjar ta ’ infezzjoni bil- virus ta ’ l - immunodefiċjenza tal- bniedem (HIV).
Posology Adults: the recommended dose of Atripla is one tablet taken orally once daily.
Pożoloġija Adulti: id- doża rrikkmandata ta ’ Atripla hija pillola waħda mittieħda oralment darba kuljum.
Method of administration It is recommended that Atripla be swallowed whole with water.
2 Metodu ta ’ kif għandha tingħata Huwa rrikkmandat li Atripla tinbela ’ sħiħa ma ’ l- ilma.
It is recommended that Atripla be taken on an empty stomach since food may increase efavirenz exposure and may lead to an increase in the frequency of adverse reactions (see sections 4.4 and 4.8).
Huwa rrikkmandat li Atripla tittieħed fuq stonku vojt peress li l- ikel jista ’ jżid l- esponiment ta ’ efavirenz u jwassal għal żieda fil- frekwenza tar- reazzjonijiet avversi (ara sezzjoniiet 4. 4 u 4. 8).
2 In order to improve the tolerability to efavirenz with respect to undesirable effects on the nervous system, bedtime dosing is recommended (see section 4.8).
Sabiex tittejjeb it- tollerabilità għal efavirenz fir- rigward ta ’ l- effetti mhux mixtieqa fuq is- sistema nervuża, huwa rakkomandat dożar fil- ħin ta ’ l- irqad (ara sezzjoni 4. 8).
It is anticipated that tenofovir exposure will be approximately 35% lower following administration of Atripla on an empty stomach as compared to the individual component tenofovir disoproxil fumarate when taken with food (see section 5.2).
Huwa mistenni li l- esponiment ta ’ tenofovir ikun madwar 35% aktar baxx wara l- għoti ta ’ Atripla fuq stonku vojt meta mqabbel mal- komponent individwali tenofovir disoproxil fumarate meta mogħti ma ’ l- ikel (ara sezzjoni 5. 2).
In virologically suppressed patients, the clinical relevance of this reduction can be expected to be limited (see section 5.1).
F’ pazjenti viroloġikament soppressi, ir- rilevanza klinika ta ’ dan it- tnaqqis tista ’ tkun mistennija li tkun limitata (ara sezzjoni 5. 1).
Further data on the clinical translation of the decrease in pharmacokinetic exposure is awaited.
Aktar dejta dwar il- fehma klinika tat- tnaqqis fl- esponiment farmakokinetiku hija mistennija.
Atripla is not recommended for use in children below 18 years of age due to lack of data on safety and efficacy.
Atripla mhux irrikkmandat għall- użu fit- tfal ta ’ taħt it- 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
Elderly: insufficient numbers of elderly patients have been evaluated in clinical studies of the components of Atripla to determine whether they respond differently than younger patients.
Anzjani: numru insuffiċjenti ta ’ pazjenti anzjani ġew evalwati fi studji kliniċi tal- komponenti ta ’ Atripla biex jiddeterminaw jekk huma jirreaġġixxux differenti minn pazjenti iżgħar.
Caution should be exercised when prescribing Atripla to the elderly, keeping in mind the greater frequency of decreased hepatic or renal function in these patients.
Għandha tintuża kawtela meta wieħed jordna Atripla lill- anzjani, u tinżamm fil- moħħ il- frekwenza akbar ta ’ tnaqqis fil - funzjoni epatika jew renali f’ dawn il- pazjenti.
Dose adjustment: if Atripla is co-administered with rifampicin, an additional 200 mg/ day (800 mg total) of efavirenz is recommended (see section 4.5).
Aġġustament fid- doża: jekk Atripla tingħata flimkien ma ’ rifampicin, 200 mg/ kuljum (total 800 mg) ta ’ efavirenz addizzjonali huma rrikkmandati (ara sezzjoni 4. 5).
Atripla is not recommended for patients with moderate or severe renal impairment (creatinine clearance (CrCl) < 50 ml/ min).
Atripla mhix irrikkmandata għal pazjenti b’ indeboliment renali moderat jew sever (rata tat- tneħħija tal- krejatinina (CrCl) < 50 ml/ min).
Patients with moderate or severe renal impairment require dose interval adjustment of emtricitabine and tenofovir disoproxil fumarate that cannot be achieved with the combination tablet (see sections 4.4 and 5.2).
Pazjenti b’ indeboliment renali moderat jew sever jeħtieġu aġġustament ta ’ l- intervall tad- doża ta ’ emtricitabine u tenofovir disoproxil fumarate li ma tistax tinkiseb bil- pillola tal- kombinazzjoni (ara sezzjonijiet 4. 4 u 5. 2).
Hepatic impairment: the pharmacokinetics of Atripla have not been studied in patients with hepatic impairment.
Indeboliment epatiku: il- farmakokinetiċi ta ’ Atripla ma ġewx studjati f’ pazjenti b’ indeboliment epatiku.
Patients with mild-to-moderate liver disease (Child-Pugh-Turcotte (CPT), Grade A or B) may be treated with the normal recommended dose of Atripla (see sections 4.3, 4.4 and 5.2).
Pazjenti b’ mard tal- fwied ħafif għal moderat (Child- Pugh- Turcotte (CPT), Grad A jew B) jistgħu jiġu ttrattati bid- doża normali rrikkmandata ta ’ Atripla (ara sezzjonijiet 4. 3, 4. 4 u 5. 2).
Patients should be monitored carefully for adverse reactions, especially nervous system symptoms related to efavirenz (see sections 4.3 and 4.4).
Il - pazjenti għandhom jiġu sorveljati bir- reqqa għal reazzjonijiet avversi, speċjalment sintomi tas- sistema nervuża relatati ma ’ efavirenz (ara sezzjonijiet 4. 3 u 4. 4).
If Atripla is discontinued in patients co-infected with HIV and HBV, these patients should be closely monitored for evidence of exacerbation of hepatitis (see section 4.4).
Jekk Atripla titwaqqaf f’ pazjenti ko- infettati bl- HIV u l- HBV, dawn il- pazjenti għandhom jiġu sorveljati mill- qrib għal taħrix ta ’ l- epatite (ara sezzjoni 4. 4).
It is important to take Atripla on a regular dosing schedule to avoid missing doses.
Huwa importanti li tieħu Atripla fuq skeda regolari ta ’ dożaġġ biex tevita li taqbeż xi dożi.
Patients should be told that if they forget to take Atripla, they should take the missed dose right away, unless it is less than 12 hours until the next day’ s dose.
Il- pazjenti għandhom jiġu avżati li jekk jinsew jieħdu Atripla, huma għandhom jieħdu d- doża fil- pront, sakemm ma jkunx baqa ’ anqas minn 12- il siegħa sad- doża tal- jum li jmiss.
In this case, patients should be told not to take the missed dose and to take their next dose at the usual time.
F’ dan il- każ, il- pazjenti għandhom jiġu avżati biex ma jeħdux id- doża li nsew u biex jieħdu d- doża li jmiss fil- ħin tas- soltu.
Where discontinuation of therapy with one of the components of Atripla is indicated or where dose modification is necessary, separate preparations of efavirenz, emtricitabine and tenofovir disoproxil fumarate are available.
Fejn jiġi indikat it- twaqqif tat- terapija b’ wieħed mill- komponenti ta ’ Atripla jew fejn tkun meħtieġa modifikazzjoni tad- doża, jinstabu preparazzjonijiet separati ta ’ efavirenz, emtricitabine u tenofovir disoproxil fumarate.
Please refer to the Summary of Product Characteristics for these medicinal products.
Jekk jogħġbok irreferi għas- Sommarju tal- Karatteristiċi tal- Prodott għal dawn il - prodotti mediċinali.
If therapy with Atripla is discontinued, consideration should be given to the long half-life of efavirenz (see section 5.2) and long intracellular half-lives of tenofovir and emtricitabine.
Jekk titwaqqaf t- terapija b’ Atripla, għandha tingħata konsiderazzjoni għall- half- life twila ta ’ efavirenz (ara sezzjoni 5. 2) u l- half- lives intraċellulari twal ta ’ tenofovir u emtricitabine.
Because of interpatient variability in these parameters and concerns regarding development of resistance, HIV treatment guidelines should be consulted, also taking into consideration the reason for discontinuation.
Minħabba l- varjabilità bejn il- pazjenti f’ dawn il- parametri u tħassib dwar l- iżvilupp ta ’ reżistenza, għandhom jiġu kkonsultati linji gwida għat- trattament ta ’ l- HIV, kif ukoll tittieħed f’ konsiderazzjoni r- raġuni għat- twaqqif.
Atripla must not be used in patients with severe hepatic impairment (CPT Grade C) (see section 5.2).
Atripla m’ għandhiex tintuża f’ pazjenti b’ indeboliment epatiku sever (CPT Grad Ċ) (ara sezzjoni 5. 2).
Atripla must not be administered concurrently with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, or ergot alkaloids (for example, ergotamine, dihydroergotamine,
Atripla m’ għandhiex tingħata fl- istess ħin ma ’ terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, jew alkalojdi ergotina (per eżempju, ergotamine, dihydroergotamine, ergonovine, u methylergonovine), għaliex kompetizzjoni għaċ- ċitokroma P450 (CYP) 3A4 minn efavirenz tista ’ tirriżulta f’ impediment tal- metaboliżmu u toħloq il- potenzjal għal effetti mhux mixtieqa serji u/ jew ta ’ theddid għall- ħajja (per eżempju, arritmiji kardijaċi, sedazzjoni fit- tul jew depressjoni respiratorja) (ara sezzjoni 4. 5).
Herbal preparations containing St.
Preparazzjonijiet tal- ħxejjex li fihom St.
John’ s wort (Hypericum perforatum) must not be used while taking Atripla due to the risk of decreased plasma concentrations and reduced clinical effects of efavirenz (see section 4.5).
John’ s wort (Hypericum perforatum) m’ għandhomx jintużaw waqt it- teħid ta ’ Atripla minħabba r- riskju ta ’ konċentrazzjonijiet fil- plażma mnaqqsa u tnaqqis fl - effetti kliniċi ta ’ efavirenz (ara sezzjoni 4. 5).
Efavirenz significantly decreases voriconazole plasma concentrations while voriconazole also significantly increases efavirenz plasma concentrations.
Efavirenz inaqqas sinifikattivament il- konċentrazzjonijiet fil- plażma ta ’ voriconazole waqt li voriconazole ukoll iżid sinifikattivament il- konċentrazzjonijiet fil- plażma ta ’ efavirenz.
Since Atripla is a fixed-dose combination product, the dose of efavirenz cannot be altered; therefore, voriconazole and Atripla must not be co-administered (see section 4.5).
Peress li Atripla huwa prodott kombinat ta ’ doża fissa, id- doża ta ’ efavirenz ma tistax tinbidel; għaldaqstant, voriconazole u Atripla ma għandhomx jingħataw flimkien (ara sezzjoni 4. 5).
General: as a fixed combination, Atripla should not be administered concomitantly with other medicinal products containing any of the same active components, efavirenz, emtricitabine or tenofovir disoproxil fumarate.
Ġenerali: bħala kumbinazzjoni fissa, Atripla m’ għandhiex tingħata fl- istess ħin ma ’ prodotti mediċinali oħra li fihom l- istess komponenti attivi, efavirenz, emtricitabine jew tenofovir disoproxil fumarate.
Due to similarities with emtricitabine, Atripla should not be administered concomitantly with other cytidine analogues, such as lamivudine (see section 4.5).
Minħabba xebh ma ’ emtricitabine, Atripla m’ għandhiex tingħata fl- istess ħin ma ’ analogi cytidine oħra, bħal lamivudine (ara sezzjoni 4. 5).
Atripla should not be administered concomitantly with adefovir dipivoxil.
Atripla m’ għandhiex tingħata fl- istess ħin ma ’ adefovir dipivoxil.
Currently available data indicate a trend that in patients on a PI-based antiretroviral regimen the switch to Atripla may lead to a reduction of the response to the therapy (see section 5.1).
Dejta li hemm disponibbli bħalissa tindika tendenza li f’ pazjenti fuq reġim ta ’ trattament antiretrovirali ibbażat fuq il- PI, il- bidla għal Atripla tista ’ twassal għal tnaqqis fir- rispons għat- terapija (ara sezzjoni 5. 1).
These patients should be carefully monitored for rises in viral load and, since the safety profile of efavirenz differs from that of protease inhibitors, for adverse reactions.
Dawn il- pazjenti għandhom jiġu sorveljati bir- reqqa għal żidiet fl- għadd virali u, billi l- profil tas- sigurtà ta ’ efavirenz hu differenti minn dak tal- inibituri tal- protease, għal reazzjonijiet avversi.
Lactic acidosis: lactic acidosis, usually associated with hepatic steatosis, has been reported with the use of nucleoside analogues.
Aċidożi lattika: aċidozi lattika, ġeneralment assoċjata ma ’ stejatożi epatika, ġiet irrapportata bl- użu ta ’ analogi tan- nukleosidi.
Early symptoms (symptomatic hyperlactataemia) include benign digestive symptoms (nausea, vomiting and abdominal pain), non-specific malaise, loss of appetite, weight loss, respiratory symptoms (rapid and/ or deep breathing) or neurological symptoms (including motor weakness).
Sintomi bikrija (iperlaktatimja sintomatika) jinkludu sintomi diġestivi beninni (nawsja, rimettar u uġigħ addominali), telqa mhux speċifika, telf ta ’ l- aptit, telf ta ’ piż, sintomi respiratorji (teħid tan- nifs mgħaġġel u/ jew fil- fond jew sintomi newroloġiċi (inkluż dgħjufija motorili).
Lactic acidosis has a high mortality and may be associated with pancreatitis, liver failure or renal failure.
Aċidożi lattika għandha mortalità għolja u tista ’ tkun assoċjata ma ’ pankreatite, insuffiċjenza tal- fwied jew insuffiċjenza renali.
Lactic acidosis generally occurred after a few or several months of treatment.
Aċidożi lattika ġeneralment isseħħ wara ftit jew bosta xhur ta ’ trattament.
Treatment with nucleoside analogues must be discontinued in the setting of symptomatic hyperlactataemia and metabolic/ lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels.
It- trattament b’ analogi tan- nukleosidi għandu jitwaqqaf fi ħdan iperlaktatimja sintomatika u aċidożi metabolika/ lattika, epatomegalija progressiva, jew livelli aminotransferase li jogħlew malajr.
Caution should be exercised when administering nucleoside analogues to any patient (particularly obese women) with hepatomegaly, hepatitis or other known risk factors for liver disease and hepatic steatosis (including certain medicinal products and alcohol).
Għandha tintuża kawtela meta wieħed jagħti analogi tan- nukleosidi lil xi pazjent (partikolarment nisa ħoxnin ħafna) b’ epatomegalija, epatite jew fatturi ta ’ riskju magħrufa oħra għal mard tal- fwied u stejatożi epatika (inklużi ċerti prodotti mediċinali u alkoħol).
Co-infection with hepatitis C and treatment with alpha interferon and ribavirin may constitute a special risk.
Infezzjoni fl- istess ħin bl- epatite Ċ u trattament b’ alpha interferon u ribavirin jistgħu jikkostitwixxu riskju speċjali.
Patients at increased risk must be followed closely.
Pazjenti f’ riskju miżjud għandhom jiġu segwiti mill- qrib.
Opportunistic infections: patients receiving Atripla or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with HIV associated diseases.
4 Infezzjonijiet opportunistiċi: pazjenti li jkunu qegħdin jirċievu Atripla jew xi terapija antiretrovirali oħra jistgħu jkomplu jiżviluppaw infezzjonijiet opportunistiċi jew kumplikazzjonijiet tal- infezzjoni HIV, u għaldaqstant għandhom jibqgħu taħt sorveljanza klinika mill- qrib minn tobba esperjenzati fit - trattament ta ’ pazjenti b’ mard assoċjat ma ’ l- HIV.
Transmission of HIV: patients must be advised that antiretroviral therapies, including Atripla, have not been proven to prevent the risk of transmission of HIV to others through sexual contact or contamination with blood.
Trasmissjoni ta ’ l- HIV: il- pazjenti għandhom jiġu avżati li t- terapiji antiretrovirali, inkluż Atripla, ma ġewx ipprovati li jimpedixxu r- riskju ta ’ trasmissjoni ta ’ l- HIV lil ħaddieħor permezz ta ’ kuntatt sesswali jew kontaminazzjoni mid- demm.
Appropriate precautions must continue to be used.
Għandhom ikomplu jintużaw prekawzjonijiet adattati.
Liver disease: the pharmacokinetics, safety and efficacy of Atripla have not been established in patients with significant underlying liver disorders (see section 5.2).
Mard tal- fwied: il- farmakokinetika, is- sigurtà u l- effikaċja ta ’ Atripla ma ġewx stabbiliti f’ pazjenti b’ disturbi sinifikanti diġà eżistenti tal- fwied (ara sezzjoni 5. 2).
Atripla is contraindicated in patients with severe hepatic impairment (see section 4.3).
Atripla hija kontra- indikata f’ pazjenti b’ indeboliment epatiku sever (ara sezzjoni 4. 3).
4 by the cytochrome P450 (CYP450) system, caution should be exercised in administering Atripla to patients with mild-to-moderate liver disease.
Peress li efavirenz jiġi metabolizzat prinċipalment mis- sistema taċ- ċitokroma P450 (CYP450), għandha tiġi eżerċitata kawtela waqt l- għoti ta ’ Atripla lil pazjenti b’ mard tal- fwied ħafif għal moderat.
These patients should be carefully monitored for efavirenz adverse reactions, especially nervous system symptoms.
Dawn il- pazjenti għandhom jiġu sorveljati bir- reqqa għal reazzjonijiet avversi ta ’ efavirenz, speċjalment sintomi tas- sistema nervuża.
Laboratory tests should be performed to evaluate their liver disease at periodic intervals (see section 4.2).
Għandhom isiru testijiet tal- laboratorju biex jevalwaw il- mard tal- fwied tagħhom f’ intervalli perjodiċi (ara sezzjoni 4. 2).
Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Pazjenti b’ funzjoni ħażina diġà eżistenti tal- fwied fosthom epatite kronika attiva għandhom frekwenza miżjuda ta ’ anormalitajiet tal- funzjoni tal- fwied waqt terapija antiretrovirali kkumbinata u għandhom jiġu sorveljati skond il- prattika standard.
If there is evidence of worsening liver disease or persistent elevations of serum transaminases to greater than 5 times the upper limit of the normal range, the benefit of continued therapy with Atripla needs to be weighed against the potential risks of significant liver toxicity.
Jekk ikun hemm evidenza ta ’ deterjorament tal- mard tal - fwied jew żidiet persistenti ta ’ transaminases fis- serum għal akbar minn 5 darbiet il- limitu ta ’ fuq tal - medda normali, il- benefiċċju ta ’ terapija li tkompli b’ Atripla jeħtieġ li jiġi evalwat kontra r- riskji potenzjali ta ’ tossiċità tal- fwied sinifikattiva.
In such patients, interruption or discontinuation of treatment must be considered (see section 4.8).
F’ pazjenti bħal dawn, għandhom jiġu kkunsidrati l - interruzzjoni jew twaqqif tat- trattament (ara sezzjoni 4. 8).
In patients treated with other medicinal products associated with liver toxicity, monitoring of liver enzymes is also recommended.
F’ pazjenti ttrattati bi prodotti mediċinali oħra assoċjati ma ’ tossiċità tal- fwied, hija wkoll irrikkmandata sorveljanza ta ’ l- enzimi tal- fwied.
Patients with HIV and hepatitis B (HBV) or C virus (HCV) co-infection: patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Pazjenti bl- HIV jew b’ ko- infezzjoni bil- virus ta ’ l- epatite B (HBV) jew Ċ (HCV): pazjenti b’ epatite B jew Ċ kronika u ttrattati b’ terapija antiretrovirali kkumbinata huma f’ riskju miżjud għal reazzjonijiet epatiċi severi u potenzjalment fatali.
Physicians should refer to current HIV treatment guidelines for the optimal management of HIV infection in patients co-infected with HBV.
It- tobba għandhom jirreferu għal linji gwida kurrenti tat- trattament tal- HIV għall- immaniġġjar ottimu ta ’ infezzjoni ta ’ l- HIV f’ pazjenti ko- infettati bl- HBV.
In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant Summary of Product Characteristics for these medicinal products.
F’ każ ta ’ terapija antivirali konkomitanti għall- epatite B jew Ċ, jekk jogħġbok irreferi wkoll għas - Sommarju tal- Karatteristiċi tal- Prodott rilevanti għal dawn il- prodotti mediċinali.
The safety and efficacy of Atripla have not been studied for the treatment of chronic HBV infection.
Is- sigurtà u l- effikaċja ta ’ Atripla ma ġewx studjati għat- trattament ta ’ infezzjoni HBV kronika.
Emtricitabine and tenofovir individually and in combination have shown activity against HBV in pharmacodynamic studies (see section 5.1).
Emtricitabine u tenofovir individwalment u f’ kumbinazzjoni wrew attività kontra l- HBV fi studji farmakodinamiċi (ara sezzjoni 5. 1).
Limited clinical experience suggests that emtricitabine and tenofovir disoproxil fumarate have an anti-HBV activity when used in antiretroviral combination therapy to control HIV infection.
Esperjenza klinika limitata tissuġġerixxi li emtricitabine u tenofovir disoproxil fumarate għandhom attività kontra l- HBV meta jintużaw f’ terapija antiretrovirali kkumbinata biex tikkontrolla infezzjoni ta ’ l- HIV.
Discontinuation of Atripla therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis.
It- twaqqif ta ’ terapija b’ Atripla f’ pazjenti ko - infettati bl- HIV u l- HBV jista ’ jkun assoċjat ma ’ taħrix ta ’ l- epatite sever u akut.
Patients co-infected with HIV and HBV who discontinue Atripla must be closely monitored with both clinical and laboratory follow-up for at least four months after stopping treatment with Atripla.
Pazjenti ko- infettati bl- HIV u l- HBV li jwaqqfu Atripla jeħtieġ li jkunu sorveljati mill- qrib b’ follow- up kemm kliniku kif ukoll tal- laboratorju għal mill- anqas erba ’ xhur wara t- twaqqif tat- trattament b’ Atripla.
If appropriate, resumption of anti-hepatitis B therapy may be warranted.
Jekk ikun xieraq, it- tkomplija mill- ġdid tat- terapija kontra l- epatite B tista ’ tkun meħtieġa.
In patients with advanced liver disease or cirrhosis, treatment discontinuation is not recommended since post-treatment exacerbation of hepatitis may lead to hepatic decompensation.
F’ pazjenti b’ mard avvanzat tal- fwied jew ċirrożi, it- twaqqif tat- trattament mhuwiex rakkomandat minħabba li t- taħrix ta ’ l- epatite wara t- trattament jista ’ jwassal għal dikumpens epatiku.
Psychiatric symptoms: psychiatric adverse reactions have been reported in patients treated with efavirenz.
Sintomi psikjatriċi: ġew irrappurtati reazzjonijiet avversi psikjatriċi f’ pazjenti ttrattati b’ efavirenz.