qanastek/EMEA-V3 huggingface dataset:
Usually, your doctor will advise you to take another medicine instead of Aprovel, as Aprovel is not recommended in early pregnancy, and may cause serious harm to your baby if it is used after 3 months of pregnancy.
Normalment, it- tabib tiegħek jagħtik parir li tieħu mediċina oħra minflok Aprovel, minħabba li Aprovelmhuwiex rakkomandat kmieni matul it- tqala, u dan jista ’ jikkawża ħsara serja għat- tarbija tiegħek jekk jintuża wara l- ewwel 3 xhur tat- tqala.
Appropriate antihypertensive drug must usually replace Aprovel before starting a pregnancy.
Mediċina xierqa kontra l- pressjoni għolja għandha normalment tissostitwixxi Aprovelqabel il- bidu ta ’ tqala.
Your doctor will normally advise you to stop taking Aprovel as soon as you know you are pregnant.
Normalment, it- tabib tiegħek jagħtik il- parir li tieqaf tieħu Aprovel malli ssir taf li inti ħriġt tqila.
If you become pregnant during therapy with Aprovel, please inform and see your doctor without delay.
Jekk toħroġ tqila matul terapija b ’ Aprovel, jekk jogħġbok avża u ara lit- tabib tiegħek minnufih.
Aprovel is unlikely to affect your ability to drive or use machines.
Sewqan u tħaddim ta 'magni Mhux mistenni li Aprovel itellfek milli issuq jew tħaddem magni.
Important information about some of the ingredients of Aprovel Aprovel contains lactose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta 'Aprovel Aprovel fih lactose.
HOW TO TAKE APROVEL
KIF GĦANDEK TIEĦU APROVEL
Always take Aprovel exactly as your doctor has told you.
Dejjem għandek tieħu Aprovel skond il- parir tat- tabib.
Method of administration Aprovel is for oral use.
Metodu ta ’ għoti Aprovel huwa għal użu mill- ħalq.
You can take Aprovel with or without food.
Tista ’ tieħu Aprovel ma ’ l- ikel kif ukoll mingħajr ikel.
It is important that you continue to take Aprovel until your doctor tells you otherwise.
Huwa importanti li tkompli tieħu Aprovel sakemm it- tabib tiegħek ma jgħidlekx mod ieħor.
Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
92 F’ pazjenti bi pressjoni tad- demm għolja u b’ dijabete ta ’ tip 2, 300 mg (erba ’ pilloli kuljum) hija id- doża ta ’ manteniment ippreferuta għall- kura assoċjata ma ’ mard tal- kliewi.
86 The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.
It- tabib jista ’ jirrikmanda doża inqas, speċjalment meta tinbeda il- kura f’ ċertu pazjenti bħal dawk fuq l- emodijalisi, u dawk ’ il fuq minn 75 sena.
If you take more Aprovel than you should If you accidentally take too many tablets, contact your doctor immediately.
Jekk tieħu Aprovel aktar milli suppost Jekk aċċidentalment tieħu ħafna pilloli, ikkuntattja mill- ewwel lit- tabib tiegħek.
If a child swallows some tablets, contact your doctor immediately.
It- tfal ma għandhomx jieħdu Aprovel Aprovel ma għandux jingħata lil tfal ta ’ taħt it- 18- il sena. jekk tifel/ tifla jibla/ tibla xi pilloli, ikkuntattja mill- ewwel lit- tabib tiegħek.
If you forget to take Aprovel If you accidentally miss a daily dose, just take the next dose as normal.
Jekk tinsa tieħu Aprovel Jekk aċċidentalment taqbeż id- doża tal- ġurnata, ħu id- doża li jmiss bħas- soltu.
Like all medicines, Aprovel can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Aprovel jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
If you get any of these symptoms or get short of breath, stop taking Aprovel and contact your doctor immediately.
Jekk ikollok kwalunkwe sintomu minn dawn li ġejjin jew inkella ssofri minn qtugħ ta ’ nifs, tiħux aktar Aprovel u kkuntattja lit- tabib tiegħek minnufih.
Side effects reported in clinical studies for patients treated with Aprovel were:
L- effetti sekondarji rrappurtati fl- istudji kliniċi għall- pazjenti kkurati b’ Aprovel kienu:
Some undesirable effects have been reported since marketing of Aprovel but the frequency for them to occur is not known.
Xi effetti sekondarji ġew irrappurtati minn mindu Aprovel tqiegħed fis- suq iżda l- frekwenza li jseħħu biha mhix magħrufa.
HOW TO STORE APROVEL
KIF TAĦŻEN APROVEL
Do not use Aprovel after the expiry date which is stated on the carton and on the blister after EXP.
Tużax Aprovel wara d- data ta ’ skadenza li tidher fuq il- kartuna u fuq il- folja wara JIS.
What Aprovel contains The active substance is irbesartan.
X' fih Aprovel Is- sustanza attiva hi irbesartan.
Each tablet of Aprovel 75 mg contains 75 mg irbesartan.
Kull pillola ta ’ Aprovel 75 mg fiha 75 mg ta ’ irbesartan.
What Aprovel looks like and contents of the pack Aprovel 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.
Id- dehra ta ’ Aprovel u l- kontenuti tal- pakkett Il- pilloli Aprovel 75 mg huma bojod għal offwajt, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb stampata fuq naħa waħda u n- numru 2771 imnaqqax fuq in- naħa l- oħra.
Aprovel 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Aprovel 75 mg jinstabu f’ pakketti f’ folji ta ’ 14, 28, 56 jew 98 pillola.
INFORMATION FOR THE USER Aprovel 150 mg tablets irbesartan
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Aprovel 150 mg pilloli irbesartan
Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg (two tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
98 F’ pazjenti bi pressjoni tad- demm għolja u b’ dijabete ta ’ tip 2, 300 mg (żewġ pilloli kuljum) hija id- doża ta ’ manteniment ippreferuta għall- kura assoċjata ma ’ mard tal- kliewi.
92 The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.
It- tabib jista ’ jirrikmanda doża inqas, speċjalment meta tinbeda il- kura f’ ċertu pazjenti bħal dawk fuq l- emodijalisi, u dawk ’ il fuq minn 75 sena.
Each tablet of Aprovel 150 mg contains 150 mg irbesartan.
Kull pillola ta ’ Aprovel 150 mg fiha 150 mg ta ’ irbesartan.
What Aprovel looks like and contents of the pack Aprovel 150 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2772 engraved on the other side.
Id- dehra ta ’ Aprovel u l- kontenuti tal- pakkett Il- pilloli Aprovel 150 mg huma bojod għal offwajt, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb stampata fuq naħa waħda u n- numru 2772 imnaqqax fuq in- naħa l- oħra.
Aprovel 150 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Aprovel 150 mg jinstabu f’ pakketti f’ folji ta ’ 14, 28, 56 jew 98 pillola.
95 Latvija sanofi-aventis Latvia SIA Tel: +371 67 33 24 51
102 Latvija sanofi- aventis Latvia SIA Tel: +371 67 33 24 51
INFORMATION FOR THE USER Aprovel 300 mg tablets irbesartan
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Aprovel 300 mg pilloli irbesartan
Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred maintenance dose for the treatment of associated kidney disease.
105 F’ pazjenti bi pressjoni tad- demm għolja u b’ dijabete ta ’ tip 2, 300 mg hija id- doża ta ’ manteniment ippreferuta għall- kura assoċjata ma ’ mard tal- kliewi.
98 The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.
It- tabib jista ’ jirrikmanda doża inqas, speċjalment meta tinbeda il- kura f’ ċertu pazjenti bħal dawk fuq l- emodijalisi, u dawk ’ il fuq minn 75 sena.
Each tablet of Aprovel 300 mg contains 300 mg irbesartan.
Kull pillola ta ’ Aprovel 300 mg fiha 300 mg ta ’ irbesartan.
What Aprovel looks like and contents of the pack Aprovel 300 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2773 engraved on the other side.
Id- dehra ta ’ Aprovel u l- kontenuti tal- pakkett Il- pilloli Aprovel 300 mg huma bojod għal offwajt, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb stampata fuq naħa waħda u n- numru 2773 imnaqqax fuq in- naħa l- oħra.
Aprovel 300 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Aprovel 300 mg jinstabu f’ pakketti f’ folji ta ’ 14, 28, 56 jew 98 pillola.
101 Latvija sanofi-aventis Latvia SIA Tel: +371 67 33 24 51
109 Latvija sanofi- aventis Latvia SIA Tel: +371 67 33 24 51
INFORMATION FOR THE USER Aprovel 75 mg film-coated tablets irbesartan
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Aprovel 75 mg pilloli miksijin b’ rita irbesartan
Aprovel is unlikely to affect your ability to drive or use machines.
Sewqan u tħaddim ta ’ magni Mhux mistenni li Aprovel itellfek milli issuq jew tħaddem magni.
Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
112 F’ pazjenti bi pressjoni tad- demm għolja u b’ dijabete ta ’ tip 2, 300 mg (erba ’ pilloli kuljum) hija id- doża ta ’ manteniment ippreferuta għall- kura assoċjata ma ’ mard tal- kliewi.
104 The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.
It- tabib jista ’ jirrikmanda doża inqas, speċjalment meta tinbeda il- kura f’ ċertu pazjenti bħal dawk fuq l- emodijalisi, u dawk ’ il fuq minn 75 sena.
If you accidentally take too many tablets, contact your doctor immediately.
Jekk tieħu Aprovel aktar milli suppost Jekk aċċidentalment tieħu ħafna pilloli, ikkuntattja mill- ewwel lit- tabib tiegħek.
If you accidentally miss a daily dose, just take the next dose as normal.
Jekk tinsa tieħu Aprovel Jekk aċċidentalment taqbeż id- doża tal- ġurnata, ħu id- doża li jmiss bħas- soltu.
What Aprovel looks like and contents of the pack Aprovel 75 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2871 engraved on the other side.
Id- dehra ta ’ Aprovel u l- kontenuti tal- pakkett Il- pilloli Aprovel 75 mg huma bojod għal offwajt, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb stampata fuq naħa waħda u n- numru 2871 imnaqqax fuq in- naħa l- oħra.
Aprovel 75 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film- coated tablets.
Aprovel 75 mg miksijin b’ rita jinstabu f’ pakketti f’ folji ta ’ 14, 28, 30, 56, 84, 90 jew 98 pillola miksija b’ rita.
107 Latvija sanofi-aventis Latvia SIA Tel: +371 67 33 24 51
115 Latvija sanofi- aventis Latvia SIA Tel: +371 67 33 24 51
INFORMATION FOR THE USER Aprovel 150 mg film-coated tablets irbesartan
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Aprovel 150 mg pilloli miksijin b’ rita irbesartan
Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg (two tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.
118 F’ pazjenti bi pressjoni tad- demm għolja u b’ dijabete ta ’ tip 2, 300 mg (żewġ pilloli kuljum) hija id- doża ta ’ manteniment ippreferuta għall- kura assoċjata ma ’ mard tal- kliewi.
110 The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.
It- tabib jista ’ jirrikmanda doża inqas, speċjalment meta tinbeda il- kura f’ ċertu pazjenti bħal dawk fuq l- emodijalisi, u dawk ’ il fuq minn 75 sena.
What Aprovel looks like and contents of the pack Aprovel 150 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2872 engraved on the other side.
Id- dehra ta ’ Aprovel u l- kontenuti tal- pakkett Il- pilloli Aprovel 150 mg huma bojod għal offwajt, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb stampata fuq naħa waħda u n- numru 2872 imnaqqax fuq in- naħa l- oħra.
Aprovel 150 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film- coated tablets.
Aprovel 150 mg miksijin b’ rita jinstabu f’ pakketti f’ folji ta ’ 14, 28, 30, 56, 84, 90 jew 98 pillola miksija b’ rita.
113 Latvija sanofi-aventis Latvia SIA Tel: +371 67 33 24 51
122 Latvija sanofi- aventis Latvia SIA Tel: +371 67 33 24 51
INFORMATION FOR THE USER Aprovel 300 mg film-coated tablets irbesartan
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Aprovel 300 mg pilloli miksijin b’ rita irbesartan
Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred maintenance dose for the treatment of associated kidney disease.
125 F’ pazjenti bi pressjoni tad- demm għolja u b’ dijabete ta ’ tip 2, 300 mg hija id- doża ta ’ manteniment ippreferuta għall- kura assoċjata ma ’ mard tal- kliewi.
116 The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.
It- tabib jista ’ jirrikmanda doża inqas, speċjalment meta tinbeda il- kura f’ ċertu pazjenti bħal dawk fuq l- emodijalisi, u dawk ’ il fuq minn 75 sena.
What Aprovel looks like and contents of the pack Aprovel 300 mg film-coated tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2873 engraved on the other side.
Id- dehra ta ’ Aprovel u l- kontenuti tal- pakkett Il- pilloli Aprovel 300 mg huma bojod għal offwajt, ibbuzzati fuq iż- żewġ naħat, ovali, b’ qalb stampata fuq naħa waħda u n- numru 2873 imnaqqax fuq in- naħa l- oħra.
Aprovel 300 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film- coated tablets.
Aprovel 300 mg miksijin b’ rita jinstabu f’ pakketti f’ folji ta ’ 14, 28, 30, 56, 84, 90 jew 98 pillola miksija b’ rita.
119 Latvija sanofi-aventis Latvia SIA Tel: +371 67 33 24 51
129 Latvija sanofi- aventis Latvia SIA Tel: +371 67 33 24 51
What is APTIVUS?
X' inhu APTIVIRUS?
APTIVUS is a medicine containing the active substance tipranavir.
APTIVUS hi mediċina li fiha s- sustanza attiva tipranavir.
It is available as pink capsules (250 mg).
Hija disponibbli bħala kapsuli roża (250 mg).
What is APTIVUS used for?
Għalxiex jintuża APTIVUS?
APTIVUS is an antiviral medicine.
APTIVUS hu mediċina antivirali.
It is used in combination with ritonavir (another antiviral medicine) and other antiviral medicines to treat adult patients with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Jintuża flimkien ma 'ritonavir (mediċina antivirali oħra) u mediċini antivirali oħra fit- trattament ta' pazjenti adulti infettati bil- virus uman ta ’ l- immunodefiċjenza tip 1 (HIV- 1), virus li jikkawża s- sindromu ta ’ l- immunodefiċjenza akkwiżita (AIDS).
APTIVUS is used in patients who have already been treated with other antiviral medicines for HIV infection, and in whom many medicines in the same class as APTIVUS (protease inhibitors) do not work.
APTIVUS jintuża minn pazjenti li jkunu diġà ġew ittrattati b' mediċini antivirali oħra għall- infezzjoni ta 'l- HIV, u li fihom ħafna mediċini fl- istess klassi ta' APTIVIRUS (inibituri protease) ma jkunux ħadmu.
Doctors should only prescribe APTIVUS once they have looked at the antiviral medicines the patient has taken before and the likelihood that the virus will respond to the medicine.
It- tobba għandhom jippreskrivu APTIVUS wara li jkunu analizzaw x' mediċini jkun ħa l- pazjent qabel u l- probabilità li l- virus jirrispondi għall- mediċina.
How is APTIVUS used?
Kif jintuża APTIVUS?
Treatment with APTIVUS should be initiated by a doctor who has experience in the treatment of HIV-1 infection.
It- trattament b' APTIVUS għandu jinbeda minn tabib li jkollu esperjenza fil- ġestjoni ta 'l- infezzjoni ta' l- HIV.
The recommended dose of APTIVUS is 500 mg twice a day.
Id- doża rrakkomandata ta 'APTIVUS hi ta' 500 mg darbtejn kuljum.
Each dose must be taken with 200 mg ritonavir and food.
Kull doża għandha tittieħed ma '200 mg ritonavir u ma' l- ikel.
It should be used with caution in patients who have mild liver problems and should not be used in patients who have moderate or severe liver problems.
Għandu jintuża b' kawtela għal pazjenti li jkollhom problemi ħfief fil- fwied u m' għandux jintuża għal pazjenti bi problemi moderati jew serji fil- fwied.
How does APTIVUS work?
Kif jaħdem APTIVUS?
The active substance in APTIVUS, tipranavir, is a protease inhibitor.
Is- sustanza attiva f' APTIVUS, tipranavir, hija inibitur protease.
It blocks an enzyme (protease) that is involved in the reproduction of HIV.
Timblokka enzim (protease) li għandu x' jaqsam mar- riproduzzjoni ta 'l- HIV.
When the enzyme is blocked, the virus does not reproduce normally, slowing down the spread of infection.
Meta l- enzim jiġi mblukkat, il- virus ma jirriproduċix ruħu bħas - soltu, u dan inaqqas il- firxa ta 'l- infezzjoni.
Ritonavir is another protease inhibitor that is used as a ‘ booster’.
Ritonavir hu inibitur protease li jintuża bħala ‘ booster ’.
It slows down the rate at which tipranavir is broken down, increasing the levels of tipranavir in the blood.
Inaqqas ir- rata li biha jitkisser tipranavir, u dan iżid il- livell ta 'amprenavir fid- demm.
This allows a lower dose of tipranavir to be used for the same antiviral effect.
Dan jippermetti li tintuża doża iżgħar ta 'tipranavir għall- istess effett.
APTIVUS, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
APTIVUS, meħud flimkien ma 'mediċini antivirali oħra, inaqqas l- ammont ta' HIV fid- demm u jżommu f' livell baxx.
APTIVUS 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.
APTIVUS ma jfejjaqx infezzjoni ta 'l- HIV jew ta' l- AIDS, iżda jista 'jtawwal iż- żmien qabel ma ssir ħsara lis- sistema immunitarja u l- iżvilupp ta' infezzjonijiet u mardiet marbuta ma 'l- AIDS.
How has APTIVUS been studied?
Kif ġie studjat APTIVUS?
APTIVUS has been studied in two main studies, involving 1,177 adults who had received many different antiviral medicines before, and were not responding to their current treatment combination 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
APTIVUS ġie studjat f' żewġ studji ewlenin li fihom ħadu sehem 1, 177 adult li kienu ngħataw diversi mediċini antivirali oħra qabel, u li ma kinux qed jirrispondu għat- trattament kurrenti kombinat attwali 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged including a protease inhibitor.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged tagħhom, inkluż dak b ’ inibitur protease.
Both studies compared the effects of APTIVUS to those of another protease inhibitor chosen on the basis of the patient ’ s previous treatments and predicted response.
Iż- żewġ studji qabblu l- effetti ta 'APTIVUS ma' dawk ta 'inibitur protease ieħor magħżul skond it- trattamenti preċedenti li jkun ħa l- pazjent u skond ir- rispons li jkun mistenni.
Each patient also took ritonavir and a combination of other anti-HIV medicines that were chosen as they had the best chances of reducing the levels of HIV in their blood.
Kull pazjent ingħata wkoll kombinazzjoni ta 'mediċini oħra ta' kontra l- HIV li ntgħażlu għax kellhom l- aqwa ċans li jnaqqsu l- livelli ta 'l- HIV fid- demm.
The results of the main measures of effectiveness (the number of patients in whom treatment had been successful and the average time to the failure of treatment) were not available at the time of the assessment, so the company presented information on the change in the levels of HIV in the patients’ blood (viral load) after 24 weeks of treatment.
Ir- riżultati tal- mezzi ewlenin tal- kejl ta 'l- effettività (in- numru ta' pazjenti li fihom it- trattament kien suċċess u l- ammont medju ta 'żmien li għadda sa ma falla t- trattament) ma kinux disponibbli sa żmien il- valutazzjoni, u għalhekk il- kumpanija ppreżantat tagħrif dwar it- tibdil fil- livelli ta' l- HIV fid- demm tal- pazjenti (tagħbija virali) wara 24 ġimgħa ta 'trattament.
The studies were still ongoing at the time of the medicine’ s assessment.
Waqt il- valutazzjoni tal- mediċina, l- istudji kienu għadhom għaddejjin.
What benefit has APTIVUS shown during the studies?
X' inhu l- benefiċċju ta 'APTIVUS li ntwera f' dawn l- istudji?
APTIVUS, taken in combination with ritonavir, was more effective than the comparator medicines at reducing viral loads in patients with few remaining options for successful HIV treatment.
APTIVUS, meħud flimkien ma 'ritonavir, kien iktar effettiv mill- mediċini li tqabbel magħhom biex inaqqas il- tagħbija viralis f' pazjenti li kien fadlilhom biss ftit għażliet għal trattament b' suċċess għall - HIV.
In the two studies taken together, 240 (41.2%) of the 582 patients taking APTIVUS had achieved and maintained a reduction in viral load of at least 90%, compared with 109 (18.9%) of the 577 taking the comparator protease inhibitors.
Fiż- żewġ studji meħudin flimkien, 240 (41. 2%) mill- 582 pazjent li kienu qed jieħdu APTIVUS kienu laħqu u żammew tnaqqis fit- tagħbija virali ta 'mill- anqas 90%, meta mqabbel ma' 109 (18. 9%) tal- 577 li kienu qed jieħdu l- inibituri protease li tqabblu magħhom.
What is the risk associated with APTIVUS?
X' inhu r- riskju assoċjat ma 'APTIVUS?
The most common side effects when taking APTIVUS with ritonavir (seen in more than 1 patient in 10) are diarrhoea and nausea (feeling sick).
L- iktar effetti sekondarji komuni bit- teħid ta 'APTIVUS ma' ritonavir (li jidhru f' aktar minn pazjent 1 minn kull 10) huma d- dijarea u d- dardir.
For the full list of all side effects reported with APTIVUS, see the Package Leaflet.
Għal- lista sħiħa ta 'effetti sekondarji rrappurtati ma' APTIVUS, ara l- Fuljett ta 'Tagħrif.
APTIVUS should not be used in people who may be hypersensitive (allergic) to tipranavir or any of the other ingredients.
APTIVUS m' għandux jintuża minn persuni li jistgħu jkunu sensittivi żżejjed (allerġiċi) għal tipranavir jew għal xi sustanza oħra tiegħu.
APTIVUS should not be used in patients with moderate or severe problems with their liver or who are taking any of the following medicines: • rifampicin (used to treat tuberculosis), • St John’ s wort (a herbal preparation used to treat depression), • medicines that are broken down in the same way as APTIVUS or ritonavir and are harmful at high levels in the blood.
Aptivus m' għandux jintuża minn pazjenti bi problemi moderati jew severi fil- fwied jew li jkunu qed jieħdu xi mediċina minn dawn: • rifampicin (użat fit- trattament tat- tuberkulożi) • St John’ s wort (preparazzjoni tal- ħxejjex użata fit- trattament tad- dipressjoni), • mediċini li jitkissru bl- istess mod ta 'APTIVUS u li jagħmlu l- ħsara meta l- livelli tagħhom fid - demm ikunu għoljin.
See the Package Leaflet for the full list of these medicines.
Ara l- Fuljett ta 'Tagħrif għal- lista sħiħa ta' dawn il- mediċini.
Caution is also needed by patients taking APTIVUS at the same time as other medicines.
Meta APTIVUS jingħata ma 'mediċini oħra, dan għandu jsir b' kawtela kbira.
As with other anti-HIV medicines, patients taking APTIVUS may be at 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).
Bħal mediċini oħra ta 'kontra l- HIV, il- pazjenti li jkunu qed jieħdu APTIVUS jista' jkollhom riskju ta 'lipodistrofija (tibdiliet fid- distribuzzjoni tax- xaħam fid- demm), ostjonekrożi (mewt ta' tessut tal - għadam) jew sindromu tar- riattivazzjoni tas- sistema immunitarja (sintomi ta 'infezzjoni kkawżati minn sistema immunitarja li tkun qed tirkupra).
Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking APTIVUS.
Il- pazjenti li jkollhom problemi bil- fwied (inkluż l- epatite B jew Ċ) jista 'jkollhom riskju elevat ta' ħsara fil- fwied meta jieħdu APTIVUS.
Why has APTIVUS been approved?
Għaliex ġie aprovat APTIVUS?
The Committee for Medicinal products for Human Use (CHMP) decided that APTIVUS’ s benefits are greater than its risks in combination with low dose ritonavir for the treatment of HIV-1 infection in highly pre-treated adult patients with virus resistant to multiple protease inhibitors.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Mill- Bniedem (CHMP) iddeċieda li APTIVUS għandu iktar benefiċċji milli riskji meta użat flimkien ma 'doża baxxa ta' ritonavir għat- trattament ta 'l - infezzjoni bl- HIV- 1 f' pazjenti adulti li jkunu diġà ġew esposti għal ħafna trattamenti u li jkollhom virus reżistenti għal ħafna inibituri protease.
However, the committee concluded that the medicine should only be considered for use as ‘ last line’ therapy, when no other protease inhibitors are predicted to work.
Madankollu, l- kumitat iddeċieda li l- mediċina għandha tintuża biss bħala 'l- aħħar linja' ta 'terapija, meta jkun imbassar li l- ebda inibitur protease ieħor ma jkun sa jaħdem.
The medicine’ s assessment is based on the results of two studies carried out in patients who have received an average of 12 antiviral medicines for the treatment of HIV infection, with virus that is resistant to protease inhibitors.
Il- valutazzjoni tal- mediċina hi bbażata fuq ir- riżultati ta 'żewġ studji li saru f' pazjenti li kienu ngħataw medja ta' 12- il mediċina antivirali għat- trattament ta 'l- infezzjoni ta' l- HIV, b' virus reżistenti għall- inibituri protease.
The committee recommended that APTIVUS be given marketing authorisation.
Il- kumitat irrakkomanda li APTIVUS jingħata awtorizzazzjoni għat - tqegħid fis- suq.
APTIVUS has been authorised under “ Exceptional Circumstances”.
APTIVUS kien awtorizzat taħt "Ċirkustanzi ta 'Eċċezzjoni".
This means that, for scientific reasons, it has not been possible to obtain complete information about APTIVUS.
Dan ifisser li, għal raġunijiet xjentifiċi, ma kienx possibbli li jinġabar it- tagħrif kollu dwar APTIVUS.
Every year, the European Medicines Agency (EMEA) will review any new information that may become available and this summary will be updated as necessary.
Kull sena, l- Aġenzija Ewropea dwar il - Mediċini (l- EMEA) tirrevedi kwalunkwe tagħrif ġdid li jista 'jinkiseb u dan is- sommarju se jiġi aġġornat kif meħtieġ.
What information is still awaited for APTIVUS?
X' tagħrif dwar APTIVUS għadu mistenni?
The company that makes APTIVUS will supply the final results of the two main studies of the medicine.
Il- kumpannija li tagħmel APTIVUS se tipprovdi r- riżultati finali taż- żewġ studji ewlenin dwar il - mediċina.
Other information about APTIVUS:
Tagħrif ieħor dwar APTIVUS:
This summary was last updated in 02-2007.
L- EPAR sħiħ għal APTIVUS jinsab hawn.
APTIVUS 250 mg soft capsules
APTIVUS 250 mg kapsuli rotob
Each soft capsule contains 250 mg tipranavir.
Kull kapsula ratba fiha 250 mg ta 'tipranavir.
Excipients (per capsule):
Sustanzi mhux attivi (kull kapsula):
100.0 mg Ethanol, 455.0 mg Macrogolglycerol Ricinoleate and 12.6 mg Sorbitol (constituent in « Sorbitol Special-Glycerin Blend »)
100. 0 mg Ethanol, 455. 0 mg Macrogolglycerol Ricinoleate u 12. 6 mg Sorbitol (kostitwent f ’ « Sorbitol Special- Glycerin Blend »)
For a full list of excipients, see section 6.1.
Għal- lista kompleta ta ’ sustanzi mhux attivi, ara Sezzjoni 6. 1.
Each capsule is pink and is imprinted with “ TPV 250”.
Kull kapsula hija ta ’ lewn roża u fuqha hemm stampat “ TPV 250 ”.
APTIVUS, co-administered with low dose ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infection in highly pre-treated adult patients with virus resistant to multiple protease inhibitors.
4. 1 Indikazzjonijiet terapewtiċi
This indication is based on the results of two phase III studies, performed in highly pre-treated patients (median number of 12 prior antiretroviral agents) with virus resistant to protease inhibitors (see details of resistance profile of patients’ HIV at baseline in section 5.1).
Din l- indikazzjoni hi bbażata fuq ir- riżultati ta ’ żewġ studji ta 'fażi III li saret fuq pazjenti trattati diversi drabi qabel (li ngħataw medja ta' 12- il mediċina antiretrovirali) u li għandhom il- virus reżistenti għall- enżimi multipli li jaġixxu fuq il- proteini.
In deciding to initiate treatment with APTIVUS, co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents.
Id- deċiżjoni li pazjent jibda jingħata APTIVUS flimkien ma ’ doża baxxa ta 'ritonavir, għandha ssir fid- dawl ta ’ l- istorja medika tat- trattament ta' l- individwu, kif ukoll il- mod ta ’ kif il- mutazzjonijiet huma assoċjati ma ’ mediċini differenti.
Genotypic or phenotypic testing (when available) and treatment history should guide the use of APTIVUS.
Testijiet ġenotipiċi jew fenotipiċi (meta disponibbli) u l- istorja tat- trattament għandhom ikunu ta 'gwida meta jingħata APTIVUS.
Initiation of treatment should take into account the combinations of mutations which may negatively impact the virological response to APTIVUS, co-administered with low dose ritonavir (see section 5.1).
Il- bidu tat- trattament għandu jqis il- kombinazzjonijiet ta ’ mutazzjonijiet li jistgħu jikkaġunaw impatt ta ’ rispons nagattiv għal APTIVUS, li jingħata ma ’ doża baxxa ta ’ ritonavir (ara sezzjoni 5. 1).
APTIVUS must always be given with low dose ritonavir as a pharmacokinetic enhancer, and in combination with other antiretroviral medicinal products.
APTIVUS għandu dejjem jingħata ma ’ doża baxxa ta 'ritonavir bħala promotur farmakokinetiku, u flimkien ma' prodotti mediċinali antiretrovirali oħrajn.
The Summary of Product Characteristics of ritonavir must therefore be consulted prior to initiation of therapy with APTIVUS (especially as regards the contraindications, warnings and undesirable effects sections).
Il- Karatteristiċi tal- Prodott fil- Qosor ta 'ritonavir għandhom għalhekk dejjem jiġu konsultati qabel ma' tibda t- terapija b' APTIVUS (speċjalment fit- taqsimiet li għandhom x' jaqsmu ma 'kontra- indikazzjonijiet, twissijiet u effetti mhux mixtieqa).
APTIVUS should be prescribed by physicians who are experienced in the treatment of HIV-1 infection.
Ir- riċetti għal APTIVUS għandhom jinħarġu minn tobba b’ esperjenza fil- kura ta ’ l- infezzjoni ta ’ HIV- 1.
The recommended dose of APTIVUS is 500 mg, co-administered with 200 mg ritonavir (low dose ritonavir), twice daily.
Id- doża rakkomandata ta ’ APTIVUS hi ta ’ 500 mg, li għandha tingħata flimkien ma ’ 200 mg ritonavir (ritonavir b’ doża baxxa), darbtejn kuljum.
2 Paediatrics:
2 APTIVUS/ ritonavir m’ għandux jintuża f’ pazjenti li huma inkonsapevoli mit- trattament
APTIVUS is not recommended for use in children due to insufficient data on safety and efficacy.
APTIVUS mhux rakkomandat biex jintuża fit- tfal minħabba li mhemmx biżżejjed tagħrif fuq is- sigurtà u l- effikaċja.
Clinical studies of APTIVUS did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects (see section 5.2).
Studji kliniċi dwar APTIVUS ma kienux jinkludu għadd suffiċjenti ta ’ suġġetti li kellhom 65 sena jew aktar sabiex jiġi stabbilit jekk jirrispondux b’ mod differenti minn suġġetti iżgħar (ara sezzjoni 5. 2).
General:
B’ mod ġenerali:
APTIVUS soft capsules co-administered with low dose ritonavir should be taken with food (see section 5.2).
(ara sezzjoni 5. 2)
Liver impairment:
Indeboliment epatiku:
Tipranavir is metabolised by the hepatic system.
Tipranavir hu metabolizzat mis- sistema epatika.
Liver impairment could therefore result in an increase of tipranavir exposure and a worsening of its safety profile.
Għalhekk, l- indeboliment tal- fwied jista 'jirriżulta f' espożizzjoni ogħla għal tipranavir u b’ hekk jiħżien il- profil tas- sigurtà.
Therefore, APTIVUS should be used with caution, and with increased monitoring frequency, in patients with mild hepatic impairment (Child- Pugh Class A).
Għalhekk, APTIVUS għandu jintuża b' kawtela u jkun hemm frekwenza ogħla ta 'monitoraġġ, f' pazjenti li għandhom indeboliment epatiku ħafif (Child- Pugh Klassi A).
APTIVUS should not be used in patients with moderate or severe hepatic impairment (Child-Pugh Class B or C) (see sections 4.3, 4.4 and 5.2).
APTIVUS m' għandux jintuża f' pazjenti li għandhom indeboliment epatiku minn moderat sa serju (Child- Pugh Klassi B jew Ċ) (ara sezzjonijiet 4. 3, 4. 4 u 5. 2).
No dosage adjustment is required in patients with renal impairment (see sections 4.4 and 5.2).
L- ebda aġġustament fid- doża m’ hu meħtieġ f' pazjenti li għandhom indeboliment renali (ara sezzjonijiet 4. 4 u 5. 2).
Patients with moderate or severe (Child-Pugh B or C) hepatic impairment.
F' pazjenti li għandhom indeboliment epatiku minn moderat sa serju (Child- Pugh B jew Ċ).
Combination of rifampicin with APTIVUS with concomitant low dose ritonavir is contraindicated (see section 4.5).
L- għoti flimkien ta ’ rifampicin ma ’ APTIVUS ma ’ doża baxxa fl- istess ħin ta ’ ritonavir hu kontra - indikat (ara sezzjoni 4. 5).
Herbal preparations containing St John’ s wort (Hypericum perforatum) must not be used while taking APTIVUS due to the risk of decreased plasma concentrations and reduced clinical effects of tipranavir (see section 4.5).
Preparazzjonijiet bi ħxejjex li fihom St John’ s wort (Hypericum perforatum) m’ għandhomx jintużaw meta qed jittieħed APTIVUS minħabba r- riskju li titbaxxa l- konċentrazzjoni fil- plażma ta ’ tipranavir u jitnaqqsu l- effetti kliniċi (ara sezzjoni 4. 5).
Co-administration of APTIVUS with low dose ritonavir, with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/ or life-threatening events is contraindicated.
L- għoti konġunt ta 'APTIVUS flimkien ma' ritonavir b’ doża baxxa, ma ’ sustanzi attivi li huma prinċipalment dipendenti fuq CYP3A għall- eliminazzjoni, u li l- konċentrazzjoni għolja tagħhom fil- plażma hija assoċjata ma ’ perikli serji u/ jew li tista ’ tikkaġuna l- mewt hu kontraindikat.
These active substances include antiarrhythmics (amiodarone, bepridil, quinidine), antihistamines (astemizole, terfenadine), ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine), gastrointestinal motility agents (cisapride), neuroleptics (pimozide, sertindole), sedatives/ hypnotics (orally administered midazolam and triazolam.
Dawn is- sustanzi attivi jinkludu anti- arritmiċi (amiodarone, bepridil, quinidine), antiħistamini (astemizole, terfenadine), derivati ta 'ergot (dihydroergotamine, ergonovine, ergotamine, methylergonovine), dawk li jagħmlu effett fuq il- movimenti ta ’ l- istonku u l- imsaren (cisapride), newrolettiċi (pimozide, sertindole), sedattivi/ ipnotiċi (midazolam u triazolam mogħtijin b’ mod orali.
For caution on parenterally administered midazolam see section 4.5) and HMG-CoA reductase inhibitors (simvastatin and lovastatin).
Għal kawtela dwar midazolam mogħti b’ mod parenterali ara sezzjoni 4. 5) u impedituri ta 'l- enzima HMG- CoA reductase (simvastatin u lovastatin).
In addition, co-administration of APTIVUS with low dose ritonavir, with medicinal products that are highly dependent on CYP2D6 for clearance, such as the antiarrhythmics flecainide, propafenone and metoprolol given in heart failure, is contraindicated (see section 4.5).
Barra minn hekk, l- għoti konġunt ta ’ APTIVUS flimkien ma ’ ritonavir b’ doża baxxa ma ’ prodotti mediċinali oħra li l- eliminazzjoni tagħhom tiddependi principalment fuq CYP2D6, bħall- anti- arritmiċi flecainide, propafenone u metoprotol mogħti f’ falliment kardijaku, huwa kontra- indikat (ara sezzjoni 4. 5).
APTIVUS must be administered with low dose ritonavir to ensure its therapeutic effect (see section 4.2).
APTIVUS għandu jingħata ma ’ doża baxxa ta ’ ritonavir ħalli jkun żgurat l- effett terapewtiku tiegħu (ara sezzjoni 4. 2).
Failure to correctly co-administer tipranavir with ritonavir will result in reduced plasma levels of tipranavir that may be insufficient to achieve the desired antiviral effect.
3 tipranavir fil- plażma jitnaqqas u b’ hekk jista ’ ma jkollux l- effett mixtieq ta ’ kontra l- virus.
Patients should be instructed accordingly.
Il- pazjenti għandhom ikunu infurmati dwar dan.
Doses of ritonavir lower than 200 mg twice daily should not be used as they might alter the efficacy profile of the combination.
Dożi ta 'ritonavir ta' inqas minn 200 mg darbtejn kuljum m' għandhomx jintużaw billi jistgħu jibdlu l- profil ta 'effikaċja tal- kumbinazzjoni.
3 APTIVUS is not a cure for HIV-1 infection or AIDS.
APTIVUS m’ huwiex kura għall- infezzjoni b’ HIV- 1 jew għall- AIDS.
Patients receiving APTIVUS or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV-1 infection.
Pazjenti li jieħdu APTIVUS jew xi terapija antiretrovirali oħra, jistgħu jkomplu jiżviluppaw infezzjonijiet opportunistiċi u kumplikazzjonijiet oħrajn assoċjati ma ’ l- infezzjoni b’ HIV- 1.
Patients should be advised that current antiretroviral therapy has not been proven to prevent the risk of transmission of HIV to others through blood or sexual contact.
Il- pazjenti għandhom jiġu avżati li t- terapija antiretrovirali attwali ma wrietx li jista ’ jonqos ir- riskju ta ’ tifrix ta ’ HIV- 1 lill- oħrajn permezz ta ’ demm jew kuntatt sesswali.
Appropriate precautions should continue to be employed.
Prekawzjonijiet xierqa għandhom jibqgħu jittieħdu.
In general, caution should be exercised in the administration and monitoring of APTIVUS in elderly patients reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other therapy.
B’ mod ġenerali, fil- każ ta ’ pazjenti anzjani, APTIVUS għandu jingħata b’ kawtela u l - pazjenti għandhom ikunu osservati bir- reqqa minħabba l- frekwenza akbar fil- funzjonament mnaqqas tal- fwied, tal- kliewi, jew tal- qalb, u minħabba mard konkomitanti ieħor li jista ’ jkun preżenti jew minħabba terapija oħra.
Liver Disease:
Mard tal- fwied:
APTIVUS is contraindicated in patients with moderate or severe (Child-Pugh Class B or C) hepatic insufficiency.
APTIVUS huwa konta- indikat f’ pazjenti li għandhom insuffiċjenza epatika moderata jew gravi (Child- Pugh Klassi B jew Ċ).
Limited data are currently available for the use of APTIVUS, co- administered with low dose ritonavir, in patients co-infected with hepatitis B or C.
Attwalment, hemm dejta disponibbli ristretta dwar l- użu ta 'APTIVUS, mogħti flimkien ma' doża baxxa ta 'ritonavir, f' pazjenti ko- infettati b' epatite B jew Ċ.
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 events.
Pazjenti li għandhom epatite B jew Ċ kronika ttrattati b' terapija retrovirali kombinata huma f' riskju akbar ta 'effetti epatiċi avversi serji jew li jistgħu jwasslu għal mewt.
APTIVUS should be used in this patient population only if the potential benefit outweighs the potential risk, and with increased clinical and laboratory monitoring.
APTIVUS għandu jingħata f' din il- popolazzjoni biss meta s- siwi potenzjali tiegħu jisboq ir- riskju potenzjali, u b' aktar monitoraġġi kliniċi u tal- laboratorju.
In the case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant Summary of Product Characteristics for these medicinal products.
Fil- każ ta 'terapija antivirali konkomitanti għal epatite B jew Ċ, jekk jogħġbok irreferi wkoll għal Karatteristiċi tal- Prodott fil- Qosor ta' dawn il- prodotti mediċinali.
Patients with mild hepatic impairment (Child-Pugh Class A) should be closely monitored.
Pazjenti li għandhom ideboliment epatiku ħafif (Child- Pugh Klassi A) għandhom jiġu monitorati mill- qrib.
Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination therapy and should be monitored according to standard practice.
Pazjenti bi fwied indebolit, li jinkludi l- epatite kronika attiva, għandhom frekwenza ogħla ta ’ problemi fil- funzjonament tal- fwied meta jingħatawlhom terapiji kombinati u għandhom jiġu monitorati skond il- prattika standard.
APTIVUS/ ritonavir should be discontinued once signs of worsening liver function occur in patients with pre-existing liver disease.
APTIVUS/ ritonavir għandu jiġi mwaqqad la darba jkun hemm sinjali li l- funzjoni tal- fwied qed tmur għal agħar f’ pazjenti li diġà għandhom mard tal- fwied.
APTIVUS co-administered with low dose ritonavir, has been associated with reports of clinical hepatitis and hepatic decompensation, including some fatalities.
APTIVUS mogħti flimkien ma 'doża baxxa ta' ritonavir, ġie assoċjat ma 'rapporti ta' epatite klinika u mewt minħabba insuffiċjenza tal- fwied.
These have generally occurred in patients with advanced HIV disease taking multiple concomitant medicinal products.
Dawn ġeneralment seħħew f’ pazjenti fejn il- marda ta ’ l- HIV kienet avvanzata u li kienu qed jieħdu diversi prodotti mediċinali.
Caution should be exercised when administering APTIVUS, to patients with liver enzyme abnormalities or history of hepatitis.
Għandha tiġi eżerċitata kawtela meta jingħata APTIVUS, lil pazjenti li għandhom abnormalitajiet fl- enżimi tal- fwied jew storja ta 'epatite.
Increased ALAT/ ASAT monitoring should be considered in these patients.
Monitoraġġ aktar ta 'spiss għal ALAT/ ASAT għandu jiġi kkonsidrat f' dawn il- pazjenti.
APTIVUS therapy should not be initiated in patients with pre-treatment ASAT or ALAT greater than 5 times the Upper Limit Normal (ULN) until baseline ASAT/ ALAT is stabilised at less than 5X ULN, unless the potential benefit justifies the potential risk.
It- terapija b' APTIVUS m’ għandhiex tiġi mibdija f' pazjenti li l- ASAT jew l- ALAT tagħhom ta ’ qabel it- trattament huwa ta 'aktar minn 5 darbiet mil- Limitu Normali ta' Fuq (ULN) sakemm il- livell bażi ta 'riferiment ta' l- ASAT/ ALAT jiġi stabbilit f' livelli inqas minn 5X l- ULN, kemm- il darba s- siwi potenzjali jiġġustifika r- riskju potenzjali.
APTIVUS therapy should be discontinued in patients experiencing ASAT or ALAT elevations greater than 10X ULN, or developing signs or symptoms of clinical hepatitis during therapy.
It- terapija b' APTIVUS għandha tiġi mwaqqfa meta l- pazjenti jkollhom żjidiet fl- ASAT jew l- ALAT ta 'aktar minn 10X l- ULN, jew meta jiżviluppaw sinjali jew sintomi ta' epatite klinika waqt it- trattament.
If another cause is identified (eg acute hepatitis A, B or C virus, gallbladder disease, other medicinal products), then rechallenge with APTIVUS may be considered when ASAT/ ALAT have returned to the patient ’ s baseline levels.
Jekk kawża oħra tiġi identifikata (eż. virus ta ’ l- epatite A, B jew Ċ akuta, mard tal- marrara, prodotti mediċinali oħra), allura l- għoti mill- ġdid ta ’ APTIVUS għandu mnejn jiġi kkonsidrat la darba l- ASAT/ ALAT ikunu rritornaw fil- livelli ta ’ riferiment bażi tal- pazjent.
Liver monitoring:
Monitoraġġ tal- fwied:
Monitoring of hepatic tests should be done prior to initiation of therapy, after two, four and then every four weeks until 24 weeks, and then every eight to twelve weeks thereafter.
Il- monitoraġġ tat- testijiet epatiċi għandu jsir qabel ma tinbeda t- terapija, wara ġimagħtejn, erba 'ġimgħat u mbagħad kull erba ’ ġimgħat sa 24 ġimgħa u eventwalment darba kull tminja sa tnax- il ġimgħa.
Increased monitoring (i. e. prior to initiation of therapy, every two weeks during the first three months of treatment, then monthly until 48 weeks, and then every eight to twelve weeks thereafter) is warranted when APTIVUS and low dose ritonavir are administered to patients with elevated ASAT and ALAT levels, mild hepatic impairment, chronic hepatitis-B or – C or other underlying liver disease.
4 l- ewwel tliet xhur ta 'trattament, sa 48 ġimgħa, u mbagħad kull tmin sa tnax- il ġimgħa wara dan) huwa meħtieġ li jsir meta APTIVUS u doża baxxa ta' ritonavir huma amministrati lil pazjenti li għandhom livelli ta 'ASAT u ALAT ogħljin, indeboliment ħafif tal- fwied, epatite B jew Ċ kronika jew mard tal- fwied fl- isfond.
Treatment-naïve patients:
Pazjenti inkonsapevoli mit- trattament:
In a study performed in antiretroviral naïve patients, APTIVUS/ ritonavir 500/ 200 mg twice daily, as compared to lopinavir/ ritonavir, was associated with an excess in the occurrence of significant (grade 3 and 4) transaminase elevations without any advantage in terms of efficacy (trend towards a lower efficacy).
Fi studju mwettaq fuq pazjenti inkonsapevoli mit- trattament, APTIVUS/ ritonavir 500/ 200 mg darbtejn kuljum, meta mqabbel ma ’ lopinavir/ ritonavir, kien assoċjat ma ’ eċċess f’ każijiet ta ’ żidied sinifikanti ta ’ transaminase, mingħajr vantaġġ f’ termini ta ’ effikaċja (xejra lejn anqas effikaċja).
Therefore, this study was prematurely stopped after 60 weeks.
Għalhekk dan l- istudju ġie mwaqqaf b’ mod prematur wara 60 ġimgħa.
4 Renal impairment:
Indeboliment renali:
Since the renal clearance of tipranavir is negligible, increased plasma concentrations are not expected in patients with renal impairment.
Peress li r- rata ta 'eliminazzjoni renali ta' tipanivir hi neġliġibbli, żjieda fil- konċentrazzjonijiet tal- plażma mhix mistennija f' pazjenti b' indeboliment renali.
Haemophilia:
Emofilja:
There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthrosis in patients with haemophilia type A and B treated with protease inhibitors.
Kien hemm rapporti ta ’ żjieda fil- fsada, li jinkludu każijiet spontanji ta ’ ematoma tal- ġilda u emartrożi, f’ pazjenti li kellhom emofilja ta ’ tip A u B, u li kienu kkurati permezz ta ’ impedituri ta ’ l- enżimi protease.
In some patients additional Factor VIII was given.
F' xi pazjenti ngħata Fattur VIII addizzjonali.
In more than half of the reported cases, treatment with protease inhibitors was continued or reintroduced if treatment had been discontinued.
F’ aktar minn nofs tal- każijiet rapportati, il- kura permezz ta ’ impedituri ta ’ l- enżimi protease tkompliet jew reġgħet inbdiet jekk it- trattament kien twaqqaf.
A causal relationship has been evoked, although the mechanism of action had not been elucidated.
Dawn l- effetti ġew assoċjati mat- terapija b’ mod każwali iżda l- mod kif dan jiġri għadu mhux mifhum sew.
Haemaophiliac patients should therefore be made aware of the possibility of increased bleeding.
Għaldaqstant, pazjenti bl- emofilja għandhom ikunu informati dwar il- possibbiltà ta ’ żjieda fil- fsada.
Bleeding:
Fsada:
RESIST participants receiving APTIVUS/ ritonavir tended to have an increased risk of bleeding; at 24 weeks the relative risk was 1.98 (95% CI=1.03, 3.80).
Il- parteċipanti fl- istudju RESIST li kienu qed jirċievu APTIVUS/ ritonavir kellhom riskju akbar ta 'fsada; wara 24 ġimgħa r- riskju relattiv kien ta' 1. 98 (95% CI=1. 03, 3. 80).
At 48-weeks the relative risk decreased to 1.27 (95% CI=0.76, 2.12).
Wara 48 ġimgħa r- riskju relattiv tnaqqas għal 1. 27 (95% CI=0. 76, 2. 12).
There was no pattern for the bleeding events and no difference between treatment groups in coagulation parameters.
Ma kienx hemm skema fil- mod kif dehru l- effetti ta 'fsada u ma kienx hemm xi differenza bejn gruppi ta' trattament f' parametri ta 'koagulazzjoni.
The significance of this finding is being further studied.
Is- sinifikat ta 'dan l- eżitu qed jiġi studjat aktar fil- fond.