qanastek/EMEA-V3 huggingface dataset:
In the ESPRIT trial, a similar benefit at 30 days was seen.
Fil- prova ESPRIT, intwera benefiċċju simili fit- 30 jum.
The main benefit was in the reduction in further heart attacks.
Il- benefiċċju ewlieni kien fit- tnaqqis ta ’ aktar attakki tal- qalb.
What is the risk associated with INTEGRILIN?
X’ inhuma r- riskji marbuta ma ’ INTEGRILIN?
The main risk of INTEGRILIN is bleeding (in more than one in 10 patients), and this may sometimes be severe.
Ir- riskju ewlieni ta ’ INTEGRILIN huwa l- fsada (f’ aktar minn wieħed minn kull 10 pazjenti), u xi daqqiet din tista ’ tkun qawwija.
Other side effects are uncommon or rare.
Effetti sekondarji oħra mhumiex komuni jew huma rari.
For the full list of all side effects reported with INTEGRILIN, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrapportati b’ INTEGRILIN, ara l- Fuljett ta ’ Tagħrif.
INTEGRILIN should not be used in people who may be hypersensitive (allergic) to eptifibatide or any of the other ingredients, in patients who have bleeding problems or have a disease which may cause bleeding (such as stroke, severe high blood pressure), or in patients with severe liver or kidney problems.
INTEGRILIN m’ għandux jintuża f’ nies li jista ’ jkollhom sensittività eċċessiva (allerġiċi) għal eptifibatide jew għal xi sustanza oħra tiegħu, f’ pazjenti li għandhom problemi ta ’ fsada jew li għandhom xi marda li tista ’ tikkaġuna fsada (bħal ma hija puplesija, pressjoni għolja qawwija), jew f’ pazjenti bi problemi tal- fwied jew tal- kliewi qawwija.
For the full list of restrictions, see the Package Leaflet.
Għal- lista sħiħa ta ’ restrizzjonijiet, ara l - Fuljett ta ’ Tagħrif.
Why has INTEGRILIN been approved?
Għaliex ġie approvat INTEGRILIN?
The Committee for Medicinal Products for Human Use (CHMP) decided that INTEGRILIN’ s benefits are greater than its risks to prevent early myocardial infarction.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ INTEGRILIN huma akbar mir- riskji tiegħu biex jimpedixxi infart mijokardijaku bikri.
They recommended that INTEGRILIN be given marketing authorisation.
Il- kumitat irrikmanda li INTEGRILIN jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about INTEGRILIN:
Aktar tagħrif dwar INTEGRILIN:
The European Commission granted a marketing authorisation valid throughout the European Union for INTEGRILIN on 1 July 1999.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal INTEGRILIN fl- 1 ta ’ Lulju 1999.
The marketing authorisation was renewed on 1 July 2004.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fl - 1 ta ’ Lulju 2004.
The marketing authorisation holder is Glaxo Group Ltd.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq hu Glaxo Group Ltd.
The full EPAR for INTEGRILIN can be found here.
L- EPAR sħiħ dwar INTEGRILIN jista ’ jinstab minn hawnhekk.
This summary was last updated in 02-2007.
Din is- sommarju ġie aġġornat l- aħħar fi 02- 2007.
EU numbers
Numru ta ’ l- EU
Invented name Strengths
Għamla farmaċewtika
Pharmaceutical Forms
Daqs tal - pakkett
Route of administration
EU/ 1/ 99/ 109/ 001
Package size
Kunjett 1
Solution for infusion Solution for injection
Soluzzjoni għall- injezzjoni
Intravenous use Intravenous use
Użu għal ġol- vini
Vial (glass) Vial (glass)
Kunjett (tal- ħġieġ)
1 vial 1 vial
Kunjett 1
What is Intelence?
X’ inhu Intelence?
Intelence is a medicine containing the active substance etravirine.
Intelence huwa prodott mediċinali li fih is- sustanza attiva etravirine.
It is available as white, oval tablets (100 mg).
Jiġi bħala pilloli bojod, ovali (100 mg).
What is Intelence used for?
Għalxiex jintuża Intelence?
Intelence is an antiviral medicine.
Intelence huwa mediċina antivirali.
It is used to treat adults who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Jintuża biex jittratta adulti li huma infettati bil- virus tal - immunodefiċjenza umana tip 1 (HIV- 1), virus li jikkaġuna s- sindromu tal- immunodefiċjenza akkwistata (AIDS).
Intelence is only used in patients who have been treated for their HIV infection before.
Intelence jintuża biss f’ pazjenti li kienu diġà ttrattati għall- infezzjoni HIV tagħhom.
Intelence must be used together with other antiviral medicines which have to include a ‘ boosted protease inhibitor’.
Intelence għandu jintuża flimkien ma ’ mediċini antivirali oħrajn li jeħtieġu jinkludu ‘ impeditur ta ’ protiż ibbustjat ’.
How is Intelence used?
Kif jintuża Intelence?
Treatment with Intelence should be started by a doctor who has experience in the treatment of HIV infection.
Trattament b’ Intelence jeħtieġ jinbeda minn tabib li għandu esperjenza fit- trattament ta ’ infezzjoni HIV.
The recommended dose of Intelence is two tablets twice a day taken after a meal.
Id- doża rrakkomandata ta ’ Intelence hija ta ’ żewġ pilloli darbtejn kuljum li tittieħed wara ikla.
For patients who are unable to swallow the tablets, Intelence tablets can be dispersed by stirring them in a glass of water to form a milky solution, which has to be drunk immediately.
Għall- pazjenti li mhumiex kapaċi jibilgħu l- pilloli, il- pilloli Intelence jistgħu jinħallu billi tpoġġihom f’ tazza ilma filwaqt li tħawwad biex tifforma soluzzjoni qisha ħalib, li trid tinxtorob minnufih.
Intelence should be used with caution in patients who have moderate problems with their liver.
Intelence għandu jintuża b’ kawtela f’ pazjenti li għandhom problemi moderati fil- fwied tagħhom.
It is not recommended for use in patients with severe liver problems or in patients under 18 years of age because of a lack of information on safety and effectiveness in these groups.
Huwa mhuwiex irrakkomandat għall- użu f’ pazjenti bi problemi severi tal- fwied jew f’ pazjenti taħt l- età ta ’ 18- il sena minħabba nuqqas ta ’ informazzjoni dwar is- sigurtà u l- effikaċja f’ dawn il- gruppi.
It should be used with caution in patients over 65 years of age because there is limited information on its use in this age group.
Għandu jintuża bil- kawtela f’ pazjenti li għandhom iktar minn 65 sena minħabba li hemm informazzjoni limitata dwar l- użu tiegħu f’ dan il- grupp ta ’ età.
How does Intelence work?
Kif jaħdem Intelence?
The active substance in Intelence, etravirine, is a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Is- sustanza attiva f’ Intelence, etravirine, hija impeditur tan- non- nucleoside reverse transcriptase (NNRTI).
It blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells in the body and make more viruses.
Din timblokka l- attività ta ’ reverse transcriptase, enzima prodotta mill- HIV li tħalliha tinfetta ċelloli fil- ġisem u tagħmel iktar virusis.
By blocking this enzyme, Intelence, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Billi jimblokka din l- enzima, Intelence, meta meħud f’ kombinazzjoni ma ’ mediċini antivirali oħrajn, inaqqas l- ammont ta ’ HIV fid- demm u jżommu f’ livell baxx.
Intelence 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.
Intelence ma jikkurax l- infezzjoni HIV jew l- AIDS, iżda jista ’ jittardja l- ħsara lis- sistema immunitarja u l- iżvilupp ta ’ infezzjonijiet u mard ieħor assoċjat mal- AIDS.
How has Intelence been studied?
Kif ġie studjat Intelence?
The effects of Intelence were first tested in experimental models before being studied in humans.
L- effetti ta ’ Intellence għall- ewwel ġew ittestjati fuq mudelli sperimentali qabel ma ġew studjati fuq il- bniedem.
Intelence has been studied in two main studies involving a total of 1,203 HIV-infected adults who had been taking anti-HIV therapy that was not working any longer and who had few or no treatment options remaining.
Intelence ġie studjat f’ żewġ studji ewlenin li involvew total ta ’ 1, 203 adulti infettati bl- HIV li kienu qiegħdin jieħdu terapija kontra l- HIV li ma baqgħetx taħdem iktar u li kien baqgħalhom biss ftit jew ebda għażla għat- trattament.
Both studies compared the effectiveness of Intelence with that of placebo (a dummy treatment), when they were taken with boosted darunavir (a protease inhibitor), as well as at least two other antiviral medicines that were chosen for each patient as they had the best chances of reducing the levels of HIV in the blood.
Iż- żewġ studji qabblu l- effikaċja ta ’ Intelence ma ’ dik ta ’ plaċebo (trattament finta), meta ttieħdu ma ’ darunavir ibbustjat (impeditur ta ’ protiż kif ukoll ma ’ għallinqas żewġ mediċini antivirali oħrajn li kienu ntgħażlu għal kull pazjent għax kellhom l- aħjar ċansijiet li jnaqqsu l- livelli ta ’ HIV fid- demm.
The main measure of effectiveness was the number of patients with a level of HIV in the blood (viral load) that was below 50 copies/ ml after 24 weeks of treatment.
Il- miżura ewlenija tal- effikaċja kienet in- numru ta ’ pazjenti b’ livell ta ’ HIV fid- demm (tagħbija virali) li kienet taħt 50 kopja/ ml wara trattament ta ’ 24 ġimgħa.
What benefit has Intelence shown during the studies?
Liema benefiċċju wera Intelence waqt l- istudji mwettqa?
Intelence was more effective than placebo at reducing viral load.
Intelence kien iktar effettiv mill- plaċebo filli jnaqqas it- tagħbija virali.
Looking at the two studies taken together, the average patients’ viral load was 70,000 copies/ ml at the start of the studies.
Meta wieħed iħares lejn iż - żewġ studji meħudin flimkien, it- tagħbija virali medja tal- pazjenti kienet ta ’ 70, 000 kopja/ ml fil- bidu tal- istudji.
After 24 weeks, 59% of the patients taking Intelence in combination with other anti-HIV medicines (353 out of 599) had a viral load below 50 copies/ ml, compared with 41% of the patients taking placebo in combination with other anti-HIV medicines (248 out of 604).
Wara 24 ġimgħa, 59% tal- pazjenti li kienu qiegħdin jieħdu Intelence f’ kombinazzjoni ma ’ mediċini antivirali oħrajn (353 minn 599) kellhom tagħbija virali taħt 50 kopja/ ml, meta mqabblin ma ’ 41% tal- pazjenti li kienu qiegħdin jieħdu plaċebo f’ kombinazzjoni ma ’ mediċini kontra l- HIV oħrajn (248 minn 604).
What is the risk associated with Intelence?
X’ inhu r- riskju assoċjat ma ’ Intelence?
The most common side effects with Intelence (seen in between 1 and 10 patients in 100) are rash, diarrhoea, nausea (feeling sick), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), peripheral neuropathy (nerve damage in the hands and feet), headache, gastro-oesophageal reflux disease (acid reflux into the gullet), vomiting, abdominal (tummy) pain, flatulence (wind), gastritis (inflammation of the stomach lining), kidney failure, diabetes, hyperglycaemia (high blood glucose levels), hypertension (high blood pressure), fatigue (tiredness), anxiety, and insomnia (difficuly sleeping), abnormal levels of fat in the blood, increases in blood levels of some proteins and decreases in neutrophils (a type of white blood cell).
L- iktar effetti sekondarji komuni b’ Intelence (li dehru f' bejn pazjent 1 u 10 minn kull 100) huma raxx, dijarea, nawżeja (dardir), tromboċitopenija (għadd baxx ta ’ pjastrini fid- demm), anemija (għadd baxx ta ’ ċelloli tad- demm ħomor), newropatija periferali (ħsara fin- nervituri fl- idejn u fis- saqajn), uġigħ ta ’ ras, mard ta ’ rifluss gastro- esofaġeali (rifluss ta ’ aċidu fil- pajp tal- ikel), rimettar, uġigħ addominali (ta ’ żaqq), gass, gastrite (infjammazzjoni tal- inforra tal- istonku), indeboliment tal- kliewi, dijabete, ipergliċemija (livelli għoljin ta ’ glucose fid- demm), ipertensjoni (pressjoni għolja tad- demm), għeja kbira, ansjetà, u insomnja (diffikultà fl- irqad), livelli anormali ta ’ xaħam fid- demm, żidiet fil- livelli tad- demm ta ’ xi proteini u tnaqqis fin- newtrofili (tip ta ’ ċelloli tad- demm bojod).
For the full list of all side effects reported with Intelence, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji kollha rrappurtata b’ Intelence ara l- Fuljett ta ’ Tagħrif.
Intelence should not be used in people who may be hypersensitive (allergic) to etravirine or any of the other ingredients.
Intelence m’ għandux jintuża f’ nies li huma ipersensittivi (allerġiċi) għal etavirine jew għal xi sustanza oħra tiegħu.
Severe skin reactions have been reported with Intelence (rash with blisters typically on lips, mouth and eyes, sometimes with skin peeling), and treatment with Intelence should be stopped if a severe skin reaction develops.
Ġew irrapportati reazzjonijiet severi tal- ġilda b’ Intelence (raxx bl- infafet tipikament fuq ix- xofftejn, ħalq u għajnejn, xi kultant bi tqaxxir tal- ġilda), u trattament b’ Intelence għandu jitwaqqaf jekk tiżviluppa reazzjoni tal- ġilda severa.
As with other anti-HIV medicines, patients taking Intelence 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 b’ mediċini kontra l- HIV oħrajn, pazjenti li jkunu qiegħdin jieħdu Intelence jistgħu jkunu f’ riskju ta ’ lipodistrofija (bidliet fid- distribuzzjoni tax- xaħam fil- ġisem), osteonekrożi (mewt tat- tessut tal - għadam) jew sindromu ta ’ riattivazzjoni immunitarja (sintomi ta ’ infezzjoni kkawżati minn sistema immunitarja li tkun qiegħdha tirkupra).
Patients who have hepatitis B or C infection may be at an elevated risk of liver damage when taking Intelence.
Pazjenti li għandhom infezzjoni bl- epatite B jew Ċ jistgħu jkunu f’ riskju ogħla ta ’ ħsara għall- fwied meta jkunu qiegħdin jieħdu Intelence.
Why has Intelence been approved?
Għaliex ġie approvat Intelence?
The Committee for Medicinal Products for Human Use (CHMP) decided that Intelence’ s benefits are greater than its risks when used in combination with a boosted protease inhibitor and other antiretroviral medicines for the treatment of HIV-1 infection in antiretroviral treatment-experienced adult patients.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Intelence huma ikbar mir- riskji tiegħu meta użat f’ kombinazzjoni ma ’ impeditur ta ’ protiż ibbustjat u mediċini antiretrovirali oħrajn għat- trattament ta ’ infezzjoni HIV- 1 f’ pazjenti aduti li kienu ħadu trattament antiretrovirali ieħor qabel.
This indication is based on the results of two 24-week studies of Intelence taken in combination with other anti-HIV medicines including darunavir boosted with ritonavir, which were carried out in patients with virus that was not responding to NNRTIs or protease inhibitors.
Din l- indikazzjoni hija bbażata fuq ir- riżultati ta ’ żewġ studji ta ’ 24 ġimgħa ta ’ Intelence meħudin f’ kombinazzjoni ma ’ mediċini kontra l- HIV oħrajn inklużi darunavir ibbustjat b’ ritonavir, li saru f’ pazjenti b’ virus li ma kienx qiegħed jirrispondi għal NNRTIs jew impedituri protiż.
The Committee recommended that Intelence be given marketing authorisation.
Il- Kumitat irrakkomanda li Intelence jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Intelence has been given ‘ Conditional Approval’.
Intelence ingħata ‘ Approvazzjoni Kundizzjonali ’.
This means that there is more evidence to come about the medicine, in particular further information on its effectiveness and safety.
Dan ifisser li għad hemm iktar evidenza x’ tingħata dwar il- mediċina, b’ mod partikolari iktar informazzjoni fuq l- effikaċja u s- sigurtà tagħha.
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 għall- 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 Intelence?
2/ 3 Liema informazzjoni għadha mistennija għal Intelence?
The company that makes Intelence will supply the final 48-week results of the two main studies with Intelence, and will conduct an additional study to demonstrate that similar results are also seen in patients taking protease inhibitors other than boosted darunavir.
Il- kumpanija li tagħmel Intelence sejra tagħti r- riżultati finali tat- 48 ġimgħa taż- żewġ studji ewlenin b ’ Intelence, u sejra twettaq studju addizjonali biex turi li riżultati simili jidhru wkoll f’ pazjenti li jkunu qiegħdin jieħdu impedituri protiż għajr darunavir ibbustjat.
2/ 3 Other information about Intelence:
Informazzjoni oħra dwar Intelence:
The European Commission granted a marketing authorisation valid throughout the European Union for Intelence to Janssen-Cilag International NV on 28 August 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq madwar l- Unjoni Ewropea, għal Intelence lil Janssen- Cilag International NV fit- 28 ta ’ Awwissu 2008.
The full EPAR for Intelence can be found here.
L- EPAR sħiħ għal Intelence jista ’ jinstab hawnhekk.
Invented name
Isem Ivvintat
120 tablets
120 pilloli
INTELENCE 100 mg tablets
INTELENCE pilloli ta ’ 100mg
Each tablet contains 100 mg of etravirine.
Kull pillola fiha 100mg ta ’ etravirine.
Excipient:
Sustanzi mhux attivi:
Each tablet contains 160 mg lactose.
Kull pillola fiha 160mg lactose.
White to off-white, oval tablet, debossed with “ T125” on one side and “ 100” on the other side.
Pillola bajda tagħti fl- offwajt, ovali b ’ “ T125 ” imnaqqxa fuq naħa u “ 100 ” fuq in- naħa l- oħra.
INTELENCE, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients (see sections 4.4, 4.5 and 5.1).
INTELENCE, flimkien ma ’ impeditur ta ’ protease ibbustjat u prodotti mediċinali antiretrovirali oħrajn, huwa indikat għat- trattament ta ’ infezzjoni ta ’ human immunodeficiency virus tip 1 (HIV- 1) f’ pazjenti adulti li għandhom esperjenza ta ’ trattament antiretrovirali (ara sezzjonijiet 4. 4, 4. 5 u 5. 1).
This indication is based on week 24 analyses from 2 randomised, double-blind, placebo-controlled Phase III trials in highly pre-treated patients with viral strains harbouring mutations of resistance to non-nucleoside reverse transcriptase inhibitors and protease inhibitors, where INTELENCE was investigated in combination with an optimised background regimen (OBR) which included darunavir/ ritonavir (see section 5.1).
Din l- indikazzjoni hi bbażata fuq analiżi ta ’ ġimgħa 24 minn 2 provi f’ Fażi III randomised, double - blind, kontrollati bil- plaċebo f’ pazjenti li kienu diġa trattati sewwa u li għandhom razez virali li fihom mutazzjonijiet ta ’ reżistenza għal impedituri tan- non- nucleoside reverse transcriptase u impedituri tal - protease fejn INTELENCE kien investigat flimkien ma ’ reġimen fl- isfond ottimizzat (OBR) li kien jinkludi darunavir/ ritonavir (ara sezzjoni 5. 1).
Therapy should be initiated by a physician experienced in the management of HIV infection.
It- terapija għanda tinbeda minn tabib li għandu esperjenza fl- immaniġġjar tal- infezzjoni HIV.
INTELENCE must always be given in combination with other antiretroviral medicinal products.
INTELENCE għandu dejjem jingħata flimkien ma ’ prodotti mediċinali antiretrovirali oħrajn.
Adults The recommended dose of INTELENCE is 200 mg (two 100 mg tablets) taken orally twice daily (b. i. d.), following a meal (see section 5.2).
Adulti Id- doża rrakomandata ta ’ INTELENCE hija ta ’ 200mg (żewġ pilloli ta ’ 100mg) li jittieħdu mill- ħalq darbtejn kuljum (b. i. d.), wara ikla (ara sezzjoni 5. 2).
Patients who are unable to swallow INTELENCE tablets whole may disperse the tablets in a glass of water.
Pazjenti li ma jistgħux jibilgħu il- pilloli INTELENCE sħaħ jistgħu jħollu l- pilloli f’ tazza ilma.
Once dispersed, patients should stir the dispersion well and drink it immediately.
Ladarba maħlula, il- pazjenti għandhom iħawwdu t- taħlita sewwa u jixorbuha immedjatament.
The glass should be rinsed with water several times and each rinse completely swallowed to ensure the entire dose is consumed.
It- tazza għanda titlaħlaħ bl- ilma diversi drabi u kull tlaħliħa għanda tinbelgħa kompletament sabiex ikun żgur li tiġi kkunsmata d- doża kollha.
Paediatric population INTELENCE is not recommended for use in children and adolescents due to insufficient data on safety and efficacy (see section 5.2).
Popolazzjoni pedjatrika INTELENCE mhux irrakkomandat għall- użu fit- tfal u addoloxxenti peress li m’ hemmx biżżejjed tagħrif dwar is- sigurtà u l- effikaċja (ara sezzjoni 5. 2).
Elderly There is limited information regarding the use of INTELENCE in patients > 65 years of age (see section 5.2), therefore caution should be used in this population.
Anzjani Hemm tagħrif limitat rigward l- użu ta ’ INTELENCE f’ pazjenti ta ’ eta` > 65 sena (ara sezzjoni 5. 2), għalhekk għandha tintuża l- kawtela f’ din il- popolazzjoni.
Hepatic impairment No dose adjustment is suggested in patients with mild or moderate hepatic impairment (Child-Pugh Class A or B); INTELENCE should be used with caution in patients with moderate hepatic
INTELENCE għandu jintuża b’ kawtela f’ pazjenti
2 impairment.
2 b’ indeboliment epatiku moderat.
The pharmacokinetics of etravirine have not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Il- farmakokinetika ta ’ etravirine ma ġietx studjata f’ pazjenti b’ indeboliment epatiku qawwi (Child- Pugh Klassi Ċ).
Therefore, INTELENCE is not recommended in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Għalhekk INTELENCE mhux rrakkomandat f’ pazjenti b’ indeboliment epatiku qawwi (ara sezzjonijiet 4. 4 u 5. 2).
Renal impairment No dose adjustment is required in patients with renal impairment (see section 5.2).
Indeboliment renali M’ hemmx bżonn ta ’ aġġustament fid- doża f’ pazjenti b’ indeboliment renali (ara sezzjoni 5. 2).
If the patient misses a dose of INTELENCE within 6 hours of the time it is usually taken, the patient should be told to take it following a meal as soon as possible and then take the next dose at the regularly scheduled time.
Jekk pazjent jitlef doża ta ’ INTELENCE fi żmien 6 sigħat mill- ħin li suppost tittieħed, wieħed għandu jgħid lill- pazjent biex jeħodha wara ikla kemm jista jkun malajr u mbagħad jieħu d- doża segwenti fil - ħin skedat regolarment.
If a patient misses a dose by more than 6 hours of the time it is usually taken, the patient should be told not to take the missed dose and simply resume the usual dosing schedule.
Jekk pazjent jitlef doża b’ iktar minn 6 sigħat mill- ħin li suppost tittieħed, wieħed għandu jgħid lill- pazjent biex ma jieħux id- doża li tilef u biex sempliċement ikompli bl- iskeda tad- dożi tas- soltu.
Patients should be advised that current antiretroviral therapy does not cure HIV and has not been proven to prevent the transmission of HIV to others through blood or sexual contact.
Il- pazjenti għandhom jiġu mwissija li t- terapija antiretrovirali kurrenti ma tikkurax HIV u ma ġietx ippruvata li tipprevjeni t- trażmissjoni ta ’ HIV lil oħrajn mid- demm jew kuntatt sesswali.
Appropriate precautions should continue to be employed.
Għalhekk għandhom ikomplu jieħdu prekawzjonijiet adegwati.
INTELENCE should optimally be combined with other antiretrovirals that exhibit activity against the patient’ s virus (see section 5.1).
INTELENCE għandu jiġi kkombinat b’ mod ottimali ma ’ antiretrovirali oħrajn li juru attivita` kontra l - virus tal- pazjent (ara sezzjoni 5. 1).
A decreased virologic response to etravirine was observed in patients with viral strains harbouring 3 or more among the following mutations V90I, A98G, L100I, K101E/ P, V106I, V179D/ F, Y181C/ I/ V, and G190A/ S (see section 5.1).
Gie nnutat tnaqqis fir- rispons viroloġiku għal etravirine f’ pazjenti b’ razez virali li fihom 3 jew izjed mill- mutazzjonijiet segwenti V90I, A98G, L100I, K101E/ P, V106I, V179D/ F, Y181C/ I/ V, u G190A/ S (ara sezzjoni 5. 1).
Conclusions regarding the relevance of particular mutations or mutational patterns are subject to change with additional data, and it is recommended to always consult current interpretation systems for analysing resistance test results.
Konkluzzjonijiet dwar ir- rilevanza ta ’ mutazzjonijiet partikolari jew diżinn ta ’ mutazzjoni huma soġġetti għal bdil b’ informazzjoni addizzjonali, u huwa rrakkomandat li dejjem jiġu kkonsultati sistemi ta ’ interpretazzjoni kurrenti sabiex wieħed janalizza riżultati ta ’ testijiet ta ’ reżistenza.
No data other than drug-drug interaction data (see section 4.5) are available when etravirine is combined with raltegravir or maraviroc.
Mhux disponibbli informazzjoni ħlief tagħrif dwar interazzjonijiet bejn il- mediċini (ara sezzjoni 4. 5) meta etravirine huwa kkombinat ma ’ raltegravir jew maraviroc.
Cutaneous reactions Severe cutaneous adverse drug reactions have been reported with INTELENCE; Stevens-Johnson Syndrome and erythema multiforme have been rarely (< 0.1%) reported.
Reazzjonijiet fil- ġilda Ġew irrapurtati reazzjonijiet avversi qawwija fil- ġilda b’ INTELENCE; is- sindromu Stevens- Johnson u eritema multiforme ġew irrapurtati rarament (< 0. 1%).
Treatment with INTELENCE should be discontinued if a severe cutaneous reaction develops.
It- trattament b’ INTELENCE għandu jitwaqqaf jekk tiżviluppa reazzjoni fil- ġilda qawwija.
Cutaneous reactions were most frequently mild to moderate, mostly occurred in the second week of therapy, and were infrequent after week 4.
Ir- reazzjonijiet fil- ġilda l- iktar frekwenti kienu ħfief għal moderati, u l- iktar li tfaċċaw kienu fit- tieni ġimgħa ta ’ terapija, u kienu infrekwenti wara ġimgħa 4.
Cutaneous reactions were mostly self-limiting and generally resolved within 1-2 weeks on continued therapy (see section 4.8).
Ir - reazzjonijiet fil- ġilda kienu l- iktar limitati fihom infushom u ġeneralment għaddew wara 1- 2 ġimgħat ta ’ terapija kontinwata (ara sezzjoni 4. 8).
The clinical data are limited and an increased risk of cutaneous reactions in patients with a history of NNRTI-associated cutaneous reactions cannot be excluded.
It- tagħrif kliniku huwa limitat u mhux eskluż riskju akbar ta ’ reazzjonijiet fil- ġilda f’ pazjenti bi storja ta ’ reazzjonijiet fil- ġilda assoċjati ma ’ NNRTI.
Caution should be observed in such patients, especially in case of history of a severe cutaneous drug reaction.
Għandha tiġi osservata l- kawtela f’ dawn il- pazjenti, speċjalment f’ każ ta ’ storja ta ’ reazzjoni fil- ġilda qawwija għal mediċina.
When prescribing INTELENCE to women, prescribers should be aware that the incidence of cutaneous reactions was higher in women compared to men in the etravirine arm.
Meta INTELENCE jinkiteb lin- nisa, min jiktbu għandu jkun mgħarraf li l- inċidenza ta ’ reazzjonijiet fil- ġilda kienet ogħla fin- nisa meta mqabbel mal- irġiel fil- fergħa ta ’ etravirine.
Elderly Experience in geriatric patients is limited: in the Phase III trials, 6 patients aged 65 years or older and 53 patients aged 56-64 years received INTELENCE.
Anzjani L- esperjenza f’ pazjenti ġerjatriċi hija limitata: fil- provi ta ’ Fażi III, 6 pazjenti ta ’ eta` ta ’ 65 sena jew ikbar u 53 pazjent ta ’ eta` ta ’ 56- 64 sena irċevew INTELENCE.
The type and incidence of adverse reactions in patients > 55 years of age were similar to the ones in younger patients (see section 4.2 and 5.2).
It- tip u inċidenza ta ’ reazzjonijiet avversi f’ pazjenti ta ’ eta` > 55 sena kienu simili għal dawk ta ’ pazjenti iżgħar (ara sezzjonijiet 4. 2 u 5. 2)
3 Patients with coexisting conditions Hepatic impairment Etravirine is primarily metabolised and eliminated by the liver and highly bound to plasma proteins.
3 Pazjenti b’ kundizzjonijiet koeżistenti Indeboliment epatiku Etravirine huwa primarjament metabolizat u eliminat mill- fwied u huwa marbut sewwa mal- proteini tal- plażma.
Effects on unbound exposure could be expected (has not been studied) therefore caution is advised in patients with moderate hepatic impairment.
Effetti fuq espożizzjoni mhux marbuta jistgħu jkunu mistennija (ma ġewx studjati) għalhekk hija rrakkomandata l- kawtela f’ pazjenti b’ indeboliment epatiku moderat.
INTELENCE has not been studied in patients with severe hepatic impairment (Child-Pugh Class C) and its use is therefore not recommended in this group of patients (see sections 4.2 and 5.2).
INTELENCE ma ġiex studjat f’ pazjenti b’ mard epatiku qawwi (Child- Pugh Klassi C) u għalhekk mhux irrakkomandat l- użu tiegħu f’ dan il- grupp ta ’ pazjenti (ara sezzjonijiet 4. 2 u 5. 2).
Co-infection with HBV or HCV Caution should be exercised in patients co-infected with hepatitis B or C virus due to the current limited data available.
Ko- infezzjoni ma ’ HBV jew HCV Għandha tintuża l- kawtela f’ pazjenti ko- infettati bil- virus epatite B jew C peress illi t- tagħrif kurrenti disponibbli huwa limitat.
A potential increased risk of liver enzymes increase cannot be excluded.
Ma jistax jiġi eskluż i- potenzjal ta ’ żieda fir- riskju ta ’ żieda fl- enżimi tal - fwied.
Fat redistribution Combination antiretroviral therapy (CART) has been associated with redistribution of body fat (lipodystrophy) in HIV infected patients.
Ridistribuzzjoni tax- xaħam Terapija antiretrovirali kkombinata (CART) ġiet assoċjata ma ’ ridistribuzzjoni tax- xaħam tal- ġisem (lipodistrofija) f’ pazjenti infettati bl- HIV.
The long-term consequences of these events are currently unknown.
M’ humiex magħrufa l- konsegwenzi ta ’ dawn l- effetti fit- tul ta ’ żmien.
Knowledge about the mechanism is incomplete.
Informazzjoni fuq il- mekkaniżmu mhix kompleta.
A connection between visceral lipomatosis and protease inhibitors (PIs), and lipoatrophy and nucleoside reverse transcriptase inhibitors (NRTIs), has been hypothesised.
Ġiet ipotizzata rabta bejn lipomatożi tal - vixxri u impedituri ta ’ protease (PIs), u bejn lipoatrofija u impedituri tan- nucleoside reverse transcriptase (NRTIs).
A higher risk of lipodystrophy has been associated with individual factors such as older age, and with treatment related factors such as longer duration of antiretroviral treatment and associated metabolic disturbances.
Riskju ikbar ta ’ lipodistrofija ġie assoċċjat ma ’ fatturi individwali bħal eta` ikbar, u ma ’ fatturi relatati ma ’ t- trattament bħal trattament għal żmien itwal ta ’ antiretrovirali u disturbi metaboliċi assoċċjati mat- trattament.
Clinical examination should include evaluation for physical signs of fat redistribution (see section 4.8).
Eżaminazzjoni klinika għandha tinkludi evalwazzjoni għal sinjali fisiċi tar- ridistribuzzjoni tax- xaħam (ara sezzjoni 4. 8).
Immune reconstitution syndrome In HIV infected patients with severe immune deficiency at the time of institution of CART, an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Sindromu tar- rikostituzzjoni immuni F’ pazjenti infettati b’ HIV b’ defiċjenza immunitarja qawwija fiż- żmien ta ’ istituzzjoni ta ’ CART, jista ’ jkun hemm reazzjoni infjammatorja għal patoġeni li ma jurux sintomi jew patoġeni residwali opportunistiċi u jistgħu jikkawżaw kundizzjonijiet kliniċi serji jew aggravar tas- sintomi.
Typically, such reactions have been observed within the first weeks or months of initiation of CART.
Tipikament, dawn ir- reazzjonijiet ġew osservati fl- ewwel ġimgħat jew xhur mill- bidu ta ’ CART.
Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterial infections and Pneumocystis jiroveci pneumonia.
Eżempji rilevanti huma cytomegalovirus retinitis, infezzjonijiet mikobatterjali ġeneralizzati u/ jew fokali u pnewmonja Pneumocystis jiroveci.
Any inflammatory symptoms should be evaluated and treatment instituted when necessary (see section 4.8).
Kwalunkwe sintomi infjammatorji għandhom jiġu evalwati u fejn hemm bżonn jinbeda trattament (ara sezzjoni 4. 8).
Osteonecrosis Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/ or long-term exposure to CART.
Osteonekrożi Għalkemm l- etjoloġija hija kkunsidrata bħala multifatturjali (inkluż użu ta ’ kortikosteroide, konsum tal- alkoħol, immunosoppressjoni qawwija, indiċi tal- massa tal- ġisem ogħla), każijiet ta ’ osteonekrożi ġew irrapurtati partikolarment f’ pazjenti bil- marda HIV avvanzata u/ jew espożizzjoni fit- tul għal CART.
Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Pazjenti għandhom jiġu avvżati sabiex jiksbu parir mediku jekk jesperjenzaw uġigħ fil- ġogi, ebusija tal- ġogi jew diffikulta` fil- moviment.
Interactions with medicinal products It is not recommended to combine etravirine with tipranavir/ ritonavir, due to a marked pharmacokinetic interaction (76% decrease of etravirine AUC) that could significantly impair the virologic response to etravirine.
Interazzjonijiet ma ’ prodotti mediċinali Mhux irrakkomandat li tikkombina etravirine ma ’ tipranavir/ ritonavir, minħabba interazzjoni farmakokinetika li ġiet innutata sew (tnaqqis ta ’ 76% ta ’ l- AUC ta ’ etravirine) li jista ’ jdgħajjef b’ mod sinjifikanti r- rispons viroloġiku għal etraviine.
For further information on interactions with medicinal products see section 4.5.
Għal iktar informazzjoni dwar interazzjonijiet ma ’ prodotti mediċinali ara sezzjoni 4. 5.
Lactose intolerance and lactase deficiency Each tablet contains 160 mg of lactose.
Intolleranza għal lactose jew defiċjenza ta ’ lactase Kull pillola fiha 160mg ta ’ lattosju.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Pazjenti bi problemi ereditarji rari ta ’ intolleranza għal galactose, id- defiċjenza Lapp lactase jew malassorbiment ta ’ glucose- galactose m’ għandhomx jieħdu din il - mediċina.
Medicinal products that affect etravirine exposure Etravirine is metabolised by CYP3A4, CYP2C9 and CYP2C19 followed by glucuronidation by uridine diphosphate glucuronosyl transferase (UDPGT).
Prodotti mediċinali li jaffettwaw l- espożizzjoni ta ’ etravirine Etravirine huwa metabolizzat b’ CYP3A4, CYP2C9 u CYP2C19 segwit minn glukuronidazzjoni minn uridine diphosphate glucuronosyl transferase (UDPGT).
Medicinal products that induce CYP3A4, CYP2C9 or CYP2C19 may increase the clearance of etravirine, resulting in lowered plasma concentrations of etravirine.
Prodotti mediċinali li jinduċu CYP3A4,
4 Co-administration of INTELENCE and medicinal products that inhibit CYP3A4, CYP2C9 or CYP2C19 may decrease the clearance of etravirine and may result in increased plasma concentrations of etravirine.
4 CYP2C9 u CYP2C19 jistgħu jżidu t- tneħħija ta ’ etravirine, li jwasslu għal tnaqqis fil - konċentrazzjonijiet ta ’ etravirine fil- plażma.
Medicinal products that are affected by the use of etravirine Etravirine is a weak inducer of CYP3A4.
Prodotti mediċinali li jiġu affettwati mill- użu ta ’ etravirine Etravirine huwa induttur dgħajjef ta ’ CYP3A4.
Co-administration of INTELENCE with medicinal products primarily metabolised by CYP3A4 may result in decreased plasma concentrations of such medicinal products, which could decrease or shorten their therapeutic effects.
Teħid ta ’ INTELENCE flimkien ma ’ prodotti mediċinali metabolizzati primarjament minn CYP3A4 jistgħu jwasslu għal tnaqqis fil - konċentrazzjonijiet fil- plażma ta ’ dawn il- prodotti mediċinali, li jistgħu jnaqqsu jew iqassru l- effetti terapewtiċi tagħhom.
Etravirine is a weak inhibitor of CYP2C9 and CYP2C19.
Etravirine huwa impeditur dgħajjef ta ’ CYP2C9 u CYP2C19.
Co-administration with medicinal products primarily metabolised by CYP2C9 or CYP2C19 may result in increased plasma concentrations of such medicinal products, which could increase or prolong their therapeutic effect or alter their adverse events profile.
Teħid flimkien ma ’ prodotti mediċinali metabolizzati primarjament minn CYP2C9 jew CYP2C19 jistgħu jwasslu għal żieda fil - konċentrazzjonijiet fil- plażma ta ’ dawn il- prodotti mediċinali, li jistgħu jżidu jew itawwlu l- effetti terapewtiċi tagħhom jew ibiddlu l- profil tar- reazzjonijiet avversi tagħhom.
Known and theoretical interactions with selected antiretrovirals and non-antiretroviral medicinal products are listed in the table below.
Interazzjonijiet magħrufa jew tejoretiċi ma ’ ċerti antiretrovirali u prodotti mediċinali li m’ humiex antiretrovirali huma elenkati fit- tabella hawn taħt.
Interaction table Interactions between etravirine and co-administered medicinal products are listed in the table below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, not done as “ ND”, once daily as “ q. d.”, twice daily as “ b. i. d.”, confidence interval as “ CI”).
Tabella ta ’ interazzjonijiet Interazzjonijiet bejn etravirine u prodotti mediċinali meħuda flimkien huma elenkati fit- tabella hawn taħt (żieda hija indikata bħala “ ↑ ”, tnaqqis bħala “ ↓ ”, l- ebda tibdil bħala “ ↔ ”, mhux magħmul bħala “ ND ”, darba kuljum bħala “ q. d. ” darbtejn kuljum bħala “ b. i. d. ”, interval ta ’ konfidenza bħala “ CI ”).
INTERACTIONS AND DOSE RECOMMENDATIONS WITH OTHER MEDICINAL PRODUCTS Medicinal products by therapeutic areas ANTI-INFECTIVES Antiretrovirals NRTIs
INTERAZZJONIJIET U RAKKOMANDAZZJONIJIET DWAR DOŻI MA ’ PRODOTTI MEDIĊINALI OĦRAJN Prodotti mediċinali skond Effetti fuq livelli mediċinali żoni terapewtiċi Proporzjon Medju ta ’ l- Inqas Kwadrati (90% CI; 1. 00 = Mingħajr effect) ANTI- INFETTIVI Antiretrovirali NRTIs
Recommendations concerning co-administration
Rakkomandazzjonijiet dwar teħid flimkien
didanosine AUC ↔ 0.99 (0.79-1.25) didanosine Cmin ND didanosine Cmax ↔ 0.91 (0.58-1.42) etravirine AUC ↔ 1.11 (0.99-1.25) etravirine Cmin ↔ 1.05 (0.93-1.18) etravirine Cmax ↔ 1.16 (1.02-1.32)
Didanosine didanosine AUC ↔ 0. 99 (0. 79- 1. 25) 400 mg q. d. didanosine Cmin ND didanosine Cmax ↔ 0. 91 (0. 58- 1. 42) etravirine AUC ↔ 1. 11 (0. 99- 1. 25) etravirine Cmin ↔ 1. 05 (0. 93- 1. 18) etravirine Cmax ↔ 1. 16 (1. 02- 1. 32)
No significant effect on didanosine and etravirine PK parameters is seen.
Ma intwerewx effetti sinjifikanti fuq il - farmakokinetika ta’ didanosine u etravirine..
INTELENCE and didanosine can be used without dose adjustments.
INTELENCE u didanosine jistgħu jintużaw mingħajr aġġustamenti fid - doża.
tenofovir AUC ↔ 1.15 (1.09-1.21) tenofovir Cmin ↑ 1.19 (1.13-1.26) tenofovir Cmax ↑ 1.15 (1.04-1.27) etravirine AUC ↓ 0.81 (0.75-0.88) etravirine Cmin ↓ 0.82 (0.73-0.91) etravirine Cmax ↓ 0.81 (0.75-0.88)
Tenofovir tenofovir AUC ↔ 1. 15 (1. 09- 1. 21) 300 mg q. d. tenofovir Cmin ↑ 1. 19 (1. 13- 1. 26) tenofovir Cmax ↑ 1. 15 (1. 04- 1. 27) etravirine AUC ↓ 0. 81 (0. 75- 0. 88) etravirine Cmin ↓ 0. 82 (0. 73- 0. 91) etravirine Cmax ↓ 0. 81 (0. 75- 0. 88)
No significant effect on tenofovir and etravirine PK parameters is seen.
Ma intwerewx effetti sinjifikanti fuq il - farmakokinetika ta’ tenofovir u etravirine.
INTELENCE and tenofovir can be used without dose adjustments.
INTELENCE u tenofovir jistgħu jintużaw mingħajr aġġustamenti fid - doża..
Other NRTIs
NNRTIs
Not studied, but no interaction expected based on Etravirine can be used with the primary renal elimination route for other these NRTIs without dose NRTIs (e. g., abacavir, emtricitabine, lamivudine, adjustment. stavudine and zidovudine).
Etravirine jista ’ jintuża ma ’ dawn l - NRTIs mingħajr aġġustamenti fid- doża.
NNRTIs
Mhux irrakkomandat li
Efavirenz Nevirapine
Nevirapine
Combining two NNRTIs has not been shown to be beneficial.
kkombinati żewġ NNRTIs.
Concomitant use of INTELENCE with efavirenz or nevirapine may cause a significant decrease in the plasma concentration of etravirine and loss of therapeutic effect of INTELENCE.
Użu konkomitanti ta ’ INTELENCE jittieħed INTELENCE ma ’ efavirenz jew nevirapine jista ’ flimkien ma ’ NNRTIs oħrajn. jwassal għal tnaqqis sinjifkinati fil - konċentrazzjonijiet fil- plażma ta ’ etravririne u telfien tal- effetti terapewtiċi ta ’ INTELENCE.
It is not recommended to co-administer INTELENCE with other NNRTIs.
PIs – Mhux ibbustjati (i. e. mingħajr ko- amministrazzjoni ta ’ doża baxxa ritonavir)
PIs - Unboosted (i. e. without co-administration of low-dose ritonavir)
5
Not studied.
Mhux studjat.
INTELENCE is expected to increase nelfinavir plasma concentrations.
INTELENCE huwa mistenni li jżid il- konċentrazzjonijiet fil- plażma ta ’ nelfinavir.
It is not recommended to co-administer INTELENCE with nelfinavir.
Mhux irrakkomandat li INTELENCE jittieħed flimkien ma ’ nelfinavir.
Concomitant use of INTELENCE with indinavir It is not recommended to may cause a significant decrease in the plasma co-administer INTELENCE concentration of indinavir and loss of therapeutic with indinavir. effect of indinavir.
Użu konkomitanti ta ’ INTELENCE ma ’ indinavir jista ’ jwassal għal tnaqqis sinjifkinati fil- konċentrazzjonijiet fil- plażma ta ’ indinavir u telfien tal- effetti terapewtiċi ta ’ indinavir.
5
Mhux irrakkomandat li INTELENCE jiġi ko - amministrat ma ’ indinavir.
PIs - Boosted (with low-dose ritonavir)
PIs - Ibbustjati (b’ doża baxxa ritonavir)
tipranavir AUC ↑ 1.18 (1.03-1.36) tipranavir Cmin ↑ 1.24 (0.96-1.59) tipranavir Cmax ↑ 1.14 (1.02-1.27) etravirine AUC ↓ 0.24 (0.18-0.33) etravirine Cmin ↓ 0.18 (0.13-0.25) etravirine Cmax ↓ 0.29 (0.22-0.40)
tipranavir AUC ↑ 1. 18 (1. 03- 1. 36) tipranavir Cmin ↑ 1. 24 (0. 96- 1. 59) tipranavir Cmax ↑ 1. 14 (1. 02- 1. 27) etravirine AUC ↓ 0. 24 (0. 18- 0. 33) etravirine Cmin ↓ 0. 18 (0. 13- 0. 25) etravirine Cmax ↓ 0. 29 (0. 22- 0. 40)
It is not recommended to co-administer tipranavir/ ritonavir and INTELENCE (see section 4.4).
Mhux irrakkomandat li tipranavir/ ritonavir jittieħed flimkien ma ’ INTELENCE (ara sezzjoni 4. 4).
Fosamprenavir/ ritonavir amprenavir AUC ↑ 1.69 (1.53-1.86) 700/ 100 mg b. i. d. amprenavir Cmin ↑ 1.77 (1.39-2.25) amprenavir Cmax ↑ 1.62 (1.47-1.79) etravirine AUC ↔ a etravirine Cmin ↔ a etravirine Cmax ↔ a
Fosamprenavir/ ritonavir amprenavir AUC ↑ 1. 69 (1. 53- 1. 86) 700/ 100 mg b. i. d. amprenavir Cmin ↑ 1. 77 (1. 39- 2. 25) amprenavir Cmax ↑ 1. 62 (1. 47- 1. 79) etravirine AUC ↔a etravirine Cmin ↔a etravirine Cmax ↔a
Amprenavir/ ritonavir and fosamprenavir/ ritonavir may require dose reduction when co-administered with INTELENCE.
Amprenavir/ ritonavir u fosamprenavir/ ritonavir jista ’ jkollhom bżonn tnaqqis fid - doża meta jittieħdu flimkien ma ’ INTELENCE.
Using the oral solution may be considered for dose reduction.
Jista jiġi kunsidrat l- użu tas- soluzzjoni orali għal tnaqqis fid- doża.
Atazanavir/ ritonavir atazanavir AUC ↓ 0.86 (0.79-0.93) 300/ 100 mg q. d. atazanavir Cmin ↓ 0.62 (0.55-0.71) atazanavir Cmax ↔ 0.97 (0.89-1.05) etravirine AUC ↑ 1.30 (1.18-1.44) etravirine Cmin ↑ 1.26 (1.12-1.42) etravirine Cmax ↑ 1.30 (1.17-1.44)
Atazanavir/ ritonavir atazanavir AUC ↓ 0. 86 (0. 79- 0. 93) 300/ 100 mg q. d. atazanavir Cmin ↓ 0. 62 (0. 55- 0. 71) atazanavir Cmax ↔ 0. 97 (0. 89- 1. 05) etravirine AUC ↑ 1. 30 (1. 18- 1. 44) etravirine Cmin ↑ 1. 26 (1. 12- 1. 42) etravirine Cmax ↑ 1. 30 (1. 17- 1. 44)
INTELENCE and atazanavir/ ritonavir can be used without dose adjustment.
INTELENCE u atazanavir/ ritonavir jistgħu jintużaw mingħajr aġġustament fid- doża.
Darunavir/ ritonavir darunavir AUC ↔ 1.15 (1.05-1.26) 600/ 100 mg b. i. d. darunavir Cmin ↔ 1.02 (0.90-1.17) darunavir Cmax ↔ 1.11 (1.01-1.22) etravirine AUC ↓ 0.63 (0.54-0.73) etravirine Cmin ↓ 0.51 (0.44-0.61) etravirine Cmax ↓ 0.68 (0.57-0.82)
Darunavir/ ritonavir darunavir AUC ↔ 1. 15 (1. 05- 1. 26) 600/ 100 mg b. i. d. darunavir Cmin ↔ 1. 02 (0. 90- 1. 17) darunavir Cmax ↔ 1. 11 (1. 01- 1. 22) etravirine AUC ↓ 0. 63 (0. 54- 0. 73) etravirine Cmin ↓ 0. 51 (0. 44- 0. 61) etravirine Cmax ↓ 0. 68 (0. 57- 0. 82)
INTELENCE and darunavir/ ritonavir can be used without dose adjustments (see also section 5.1).
INTELENCE u darunavir/ ritonavir jistgħu jintużaw mingħajr aġġustament fid- doża (ara wkoll sezzjoni 5. 1).
Lopinavir/ ritonavir lopinavir AUC ↓ 0.80 (0.49-1.07) (soft capsule) lopinavir Cmin ↓ 0.92 (0.15-1.68) 400/ 100 mg b. i. d. lopinavir Cmax ↓ 0.85 (0.62-1.05) etravirine AUC ↑ 1.17 (0.96-1.43) etravirine Cmin ↑ 1.23 (0.98-1.53) etravirine Cmax ↑ 1.15 (0.94-1.41)
Lopinavir/ ritonavir lopinavir AUC ↓ 0. 80 (0. 49- 1. 07) (kapsula ratba) lopinavir Cmin ↓ 0. 92 (0. 15- 1. 68) 400/ 100 mg b. i. d. lopinavir Cmax ↓ 0. 85 (0. 62- 1. 05) etravirine AUC ↑ 1. 17 (0. 96- 1. 43) etravirine Cmin ↑ 1. 23 (0. 98- 1. 53) etravirine Cmax ↑ 1. 15 (0. 94- 1. 41)
INTELENCE and lopinavir/ ritonavir can be used without dose adjustments.
INTELENCE u lopinavir/ ritonavir jistgħu jintużaw mingħajr aġġustament fid- doża.
Saquinavir/ ritonavir saquinavir AUC ↔ 0.95 (0.64-1.42) 1,000/ 100 mg b. i. d. saquinavir Cmin ↓ 0.80 (0.46-1.38) saquinavir Cmax ↔ 1.00 (0.70-1.42) etravirine AUC ↓ 0.67 (0.56-0.80) etravirine Cmin ↓ 0.71 (0.58-0.87) etravirine Cmax ↓ 0.63 (0.53-0.75)
Saquinavir/ ritonavir saquinavir AUC ↔ 0. 95 (0. 64- 1. 42) 1, 000/ 100 mg b. i. d. saquinavir Cmin ↓ 0. 80 (0. 46- 1. 38) saquinavir Cmax ↔ 1. 00 (0. 70- 1. 42) etravirine AUC ↓ 0. 67 (0. 56- 0. 80) etravirine Cmin ↓ 0. 71 (0. 58- 0. 87) etravirine Cmax ↓ 0. 63 (0. 53- 0. 75)
INTELENCE and saquinavir/ ritonavir can be used without dose adjustments.
INTELENCE u saquinavir/ ritonavir jistgħu jintużaw mingħajr aġġustament fid- doża.
Entry Inhibitors
Impedituri ta ’ Dħul
maraviroc AUC ↓ 0.47 (0.38-0.58) maraviroc Cmin ↓ 0.61 (0.53-0.71) maraviroc Cmax ↓ 0.40 (0.28-0.57) etravirine AUC ↔ 1.06 (0.99-1.14) etravirine Cmin ↔ 1.08 (0.98-1.19) etravirine Cmax ↔ 1.05 (0.95-1.17)
maraviroc AUC ↓ 0. 47 (0. 38- 0. 58) maraviroc Cmin ↓ 0. 61 (0. 53- 0. 71) maraviroc Cmax ↓ 0. 40 (0. 28- 0. 57) etravirine AUC ↔ 1. 06 (0. 99- 1. 14) etravirine Cmin ↔ 1. 08 (0. 98- 1. 19) etravirine Cmax ↔ 1. 05 (0. 95- 1. 17)
The recommended dose for maraviroc when combined with INTELENCE in the presence of potent CYP3A inhibitors (e. g. boosted PIs) is 150 mg b. i. d. except for
PIs ibbustjati) hija 150 mg b. i. d.
Maraviroc/ darunavir/ ritonavir 150/ 600/ 100 mg b. i. d.
Maraviroc/ darunavir / ritonavir 150/ 600/ 100 mg b. i. d.
maraviroc AUC ↑ 3.10* (2.57-3.74) maraviroc Cmin ↑ 5.27* (4.51-6.15) maraviroc Cmax ↑ 1.77* (1.20-2.60) * compared to maraviroc 150 mg b. i. d.
maraviroc AUC ↑ 3. 10 * (2. 57- 3. 74) maraviroc Cmin ↑ 5. 27 * (4. 51- 6. 15) maraviroc Cmax ↑ 1. 77 * (1. 20- 2. 60) * compared to maraviroc 150 mg b. i. d.
fosamprenavir/ ritonavir (maraviroc dose 300 mg b. i. d.).
ħlief għal fosamprenavir/ ritonavir (doża ta ’ maraviroc 300 mg b. i. d.).
No dose adjustment for INTELENCE is necessary.
Ma hemmx bżonn ta ’ aġgustament fid- doża ta ’ INTELENCE.
Fusion Inhibitors
etravirine * C0h ↔a
etravirine* AUC ↔ a etravirine* C0h ↔ a Enfuvirtide concentrations not studied, no effect is expected. * based on population pharmacokinetic analyses
Konċentrazzjonijiet ta ’ enfuvirtide ma ġewx studjati, mhux mistennija effetti.. * ibbażat fuq analiżi tal- farmakokinetika tal- popolazzjoni
No interaction is expected for either INTELENCE or enfuvirtide when co-administered.
interazzjonijiet bejn INTELENCE jew enfuvirtide meta jittieħdu flimkien.
Integrase Strand Transfer Inhibitors
Impedituri Integrase Strand Transfer
raltegravir AUC ↓ 0.90 (0.68-1.18) raltegravir Cmin ↓ 0.66 (0.34-1.26) raltegravir Cmax ↓ 0.89 (0.68-1.15) etravirine AUC ↔ 1.10 (1.03-1.16) etravirine Cmin ↔ 1.17 (1.10-1.26) etravirine Cmax ↔ 1.04 (0.97-1.12)
raltegravir AUC ↓ 0. 90 (0. 68- 1. 18) raltegravir Cmin ↓ 0. 66 (0. 34- 1. 26) raltegravir Cmax ↓ 0. 89 (0. 68- 1. 15) etravirine AUC ↔ 1. 10 (1. 03- 1. 16) etravirine Cmin ↔ 1. 17 (1. 10- 1. 26) etravirine Cmax ↔ 1. 04 (0. 97- 1. 12)
INTELENCE and raltegravir can be used without dose adjustments.
INTELENCE u raltegravir jistgħu jintużaw mingħajr aġġustament fid- doża.
ANTIARRHYTHMICS
ANTIARRITMIĊI
Digoxin 0.5 mg single dose
Digoxin Doża singola 0. 5 mg
digoxin AUC ↑ 1.18 (0.90-1.56) digoxin Cmin ND digoxin Cmax ↑ 1.19 (0.96-1.49)
digoxin AUC ↑ 1. 18 (0. 90- 1. 56) digoxin Cmin ND digoxin Cmax ↑ 1. 19 (0. 96- 1. 49)
INTELENCE and digoxin can be used without dose adjustments.
INTELENCE u digoxin jistgħu jintużaw mingħajr aġġustament fid- doża.
It is recommended that digoxin levels be monitored when digoxin is combined with INTELENCE.
Huwa rrakkomandat li l- livelli ta ’ digoxin jiġu monitorjati meta digoxin jiġi kkombinat ma ’ INTELENCE.
Amiodarone Bepridil Disopyramide Flecainide Lidocaine (systemic) Mexiletine Propafenone Quinidine
Amiodarone Bepridil Disopyramide Flecainide Lidocaine (systemic) Mexiletine Propafenone Quinidine