qanastek/EMEA-V3 huggingface dataset:
300 and 600 mg; light orange:
300 u 600 mg; oranġjo ċar:
What is Prezista used for?
Għal xiex jintuża Prezista?
Prezista is an antiviral medicine.
Prezista huwa mediċina antivirali.
It is used together with low-dose ritonavir (another antiviral medicine) and other antiviral medicines to treat adults who are infected with human immunodeficiency virus (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Jintuża flimkien ma ’ dożi baxxi ta ’ ritonavir (mediċina antivirali oħra) u mediċini antivirali oħra biex jikkura adulti infettati bil- virus tal- immodefiċjenza umana (HIV), virus li jikkawża s- sindromu mill- immunodefiċjenza akkwiżita (AIDS).
Doctors should prescribe Prezista to patients who have been treated before, only once they have looked at the antiviral medicines that the patient has taken before and considered the likelihood of the virus responding to the medicine.
It- tobba għandhom jippreskrivu Prezista lill- pazjenti li ġew ikkurati qabel, ladarba jkunu infurmaw ruħhom sew fuq il- mediċini antivirali li l- pazjent ikun ħa qabel u jikkonsidraw il- probabilità li l- virus jirrispondi għall- mediċina.
How is Prezista used?
Kif jintuża Prezista?
Treatment with Prezista should be started by a doctor who has experience in the management of HIV infection.
It- trattament bi Prezista għandu jinbeda minn tabib li jkollu esperjenza fit- trattament ta ’ infezzjoni mill- HIV.
For patients who have not been treated before, the recommended dose is 800 mg once a day.
Għal pazjenti li ma jkunux ġew ikkurati qabel, id- doża rakkomandata hija ta ’ 800 mg darba kuljum.
For patients who have been treated before, it is 600 mg twice a day.
Għal pazjenti li jkunu ġew ikkurati qabel, id- doża ikun ta ’ 600 mg darbtejn kuljum.
Each dose of Prezista must be taken with 100 mg ritonavir and food.
Kull doża ta ’ Prezista għandha tittieħed ma '100 mg ritonavir u mal- ikel.
Prezista should be used with caution by patients with mild or moderate problems with their liver.
Prezista għandu jintuża b’ kawtela minn pazjenti bi problemi ħfief jew moderati fil- fwied.
It must not be used by patients who have severe liver problems.
Il- mediċina ma għandhiex tintuża minn pazjenti bi problemi serji fil- fwied.
How does Prezista work?
Kif jaħdem Prezista?
The active substance in Prezista, darunavir, is a protease inhibitor.
Is- sostanza attiva ta ’ Prezista, darunavir, hija inibitur tal- proteażi.
When the enzyme is blocked, the virus does not reproduce normally, slowing down the rate of replication.
Meta l- enzima tiġi imblokkata, il- virus ma jirriproduċix ruħu b’ mod normali, u jittardja l- firxa tar- replikazzjoni.
It slows down the rate at which darunavir is broken down, increasing the levels of darunavir in the blood.
Huwa jnaqqas ir- ritmu ta ’ tiksir ta ’ darunavir, u jżid il- livelli ta ’ darunavir fid- demm.
The use of the booster allows a lower dose of darunavir to be used for the same antiviral effect.
L- użu ta ’ booster jippermetti biex jintuża dożaġġ iktar baxx ta ’ darunavir għall - istess effett antivirali.
Prezista does not cure HIV infection or AIDS, but it may delay or reverse the damage to the immune system and reduce the risk of developing illnesses associated with HIV infection or AIDS.
Prezista ma jfejjaqx infezzjoni tal- HIV jew tal- AIDS, iżda jista 'jtawwal iż - żmien jew ireġġa ’ lura l- ħsara li tkun saret lis- sistema immunitarja u jnaqqas ir- riskju li jiżviluppa mard marbut mal- infezzjoni tal- HIV jew l- AIDS.
How has Prezista been studied?
Kif ġie studjat Prezista?
One study compared ritonavir-boosted Prezista with ritonavir-boosted lopinavir (another protease inhibitor) in 691 adults who had not been treated for HIV before.
Prezista ġie studjat f' erba 'studji ewlenin; Studju minnhom qabbel il- Prezista boosted bir- ritonavir ma ’ lopinavir boosted bir- ritonavir (inibitur tal- proteażi ieħor) f’ 691 adult li kienu ġew ikkurati għall- HIV qabel.
All of the patients also took tenofovir disoproxil and emtricitabine (other antiviral medicines); The other three studies involved adults who were already receiving HIV treatment but were not responding to it: • one study compared ritonavir-boosted Prezista with ritonavir-boosted lopinavir in 604 patients who had taken some anti-HIV medicines in the past; • two studies involved 628 patients who had taken many anti-HIV medicines in the past and compared ritonavir-boosted Prezista with other protease inhibitors chosen on the basis of the patient’ s previous treatments and predicted response.
Il- pazjenti kollha ħadu wkoll tenofovir disoproxil u emtricitabine (mediċini antivirali oħra); It- tliet studji l- oħra involvew adulti li kienu diġà qed jiġu kkurati kontra l- HIV iżda ma kinux qed jirrispondu għal dan it- trattament. • studju minnhom qabbel il- Prezista boosted bir- ritonavir ma ’ lopinavir boosted bir- ritonavir f’ 604 pazjenti li kienu diġà ħadu mediċini għal kontra l- HIV fil- passat. • żewġ studji involvew 628 pazjent li kienu ħadu ħafna mediċini għal kontra l- HIV fil- passat u qabbel il- Prezista boosted bir- ritonavir ma ’ inibituri tal- proteażi oħra magħżula skont il- kuri li kien ħa l- pazjent fil- passat u r- rispons imbassar.
In these three studies, the patients also took a combination of other anti-HIV medicines that were chosen because they had the best chances of reducing the levels of HIV in their blood.
F’ dawn it- tliet studji, il- pazjenti ngħataw ukoll kombinazzjoni ta 'mediċini oħra għal kontra l- HIV li ntgħażlu għax kellhom l- ikbar ċans li jnaqqsu l- livelli tal- HIV fid- demm.
In all four studies, the main measures of effectiveness were based on the change in HIV levels in the blood (viral load).
Fl- erba ’ studji li huma, il- kejl ewlieni tal- effikaċja kien ibbażat fuq il- bidliet fil- livelli tal- HIV fid - demm (tagħbija virali).
What benefit has Prezista shown during the studies?
Liema benefiċċju wera Prezista waqt l- istudji?
In patients who had not been treated before, Prezista was as effective as lopinavir.
F’ pazjenti li qatt ma kienu ġew ikkurati qabel, Prezista kien effettiv daqs lopinavir.
After 48 weeks, 84% of the patients taking ritonavir-boosted Prezista had viral loads below 50 copies/ ml (287 out of 343) compared with 78% of those taking ritonavir-boosted lopinavir (271 out of 346).
Wara 48 ġimgħa, 84% tal- pazjenti li kienu qed jieħdu l- Prezista boosted bir- ritonavir kellhom tagħbijiet virali taħt il- 50 kopja/ ml (287 minn total ta ’ 343) meta mqabbla ma ’ 78% ta ’ dawk li kienu qed jieħdu lopinavir boosted bir- ritonavir (271 minn total ta ’ 346).
In patients who had been treated before, those taking Prezista achieved lower viral loads than those taking the comparator protease inhibitors.
F’ pazjenti li kienu ġew ikkurati qabel, dawk li kienu qed jieħdu l- Prezista kisbu tagħbijiet virali iktar baxxi meta mqabbla ma ’ dawk li kienu qed jieħdu l- inibiturai ta ’ proteażi.
In the study of patients who had taken some anti-HIV medicines in the past, 77% of those taking ritonavir-boosted Prezista and 68% of those taking ritonavir-boosted lopinavir had viral loads below 400 copies/ ml after 48 weeks.
Fl- istudju tal- pazjenti li fil - passat kienu diġà ħadu xi mediċini għal kontra l- HIV, 77% ta ’ dawk li ħadu l- Prezista boostad bir - ritonavir u 68% ta ’ dawk li ħadu lopinavir boosted bir- ritonavir kellhom tagħbijiet virali taħt l- 400 kopja/ ml wara 48 ġimgħa.
In the two studies of patients who had received many anti-HIV medicines in the past, 70% of those taking the approved dose of ritonavir-boosted Prezista (92 out of 131) and 21% of the patients taking the comparator protease inhibitors (26 out of 124) had at least a 90% reduction in viral load after 24 weeks.
Fiż- żewġ studji tal- pazjenti li kienu diġà rċiverw ħafna kura kontra l- HIV fil- passat, 70% ta ’ dawk li li kienu qed jieħdu d- doża approvata ta ’ Prezista boosted bir- ritonavir (92 minn 131) u 21% tal- pazjenti li kienu qed jieħdu l- inibituri tal- proteażi li tqabblu magħhom (26 minn 124) kellhom mill- inqas 90% tnaqqis fit- tagħbija virali wara 24 ġimgħa.
What is the risk associated with Prezista?
X’ inhu r- riskju assoċjat ma ’ Prezista?
The most common side effect with Prezista (seen in more than 1 patient in 10) is diarrhoea.
L- iktar effett sekondarju komuni fi Prezista (li deher f' iktar minn pazjent wieħed minn kull għaxra) hu d- dijarrea.
For the full list of all side effects reported with Prezista, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji kollha rrappurtati fi Prezista, ara l- Fuljett ta ’ Tagħrif.
As with other anti-HIV medicines, patients taking Prezista 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 għal kontra l- HIV, il- pazjenti ttrattati bi Prezista jista ’ jkollhom riskju talipodistrofija (bidliet fid- distribuzzjoni tax- xaħam fid- demm), osteonekrożi (mewt ta ’ tessut tal - għadam) jew sindromu tar- riattivazzjoni 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 a higher risk of liver damage when taking anti-HIV medicines such as Prezista.
Il- pazjenti li jkollhom problemi bil- fwied (inkluż infezzjoni tal - epatite B u Ċ) jistgħ jkunu f’ riskju ikbar ta 'ħsara lill- fwied meta jieħdu mediċini għal kontra l- HIV bħal Prezista.
Prezista should not be taken by patients who may be hypersensitive (allergic) to darunavir or any of the other ingredients.
Prezista ma għandux jintuża f’ pazjenti li jistgħu jkunu ipersensittivi (allerġiċi) għal darunavir jew għal kwanlunkwe mill- ingredjenti l- oħra.
It must not be taken by patients who have severe problems with their liver, or who are taking the following medicines: • rifampicin (used to treat tuberculosis); • ritonavir-boosted lopinavir; • St John’ s wort (a herbal preparation used to treat depression); • medicines that are broken down in the same way as Prezista and are harmful at high levels in the blood.
M’ għandux jintuża f’ pazjenti b’ mard gravi fil- fwied jew li qed jieħdu xi waħda mill- mediċini li ġejjin: • rifampicin (użat fit- trattament tat- tuberkulożi); • Lopinavir bossted mir- ritonavir; • fexfiex tar- raba '(St John’ s wort) (preparazzjoni tal- ħxejjex użata fit- trattament tad- depressjoni); • mediċini li jitkissru bl- istess mod ta' Prezista u li jagħmlu l- ħsara meta l- livelli tagħhom fid- demm ikunu għolja.
Caution is also needed by patients taking Prezista at the same time as some other medicines.
Meta Prezista jingħata ma 'mediċini oħra, dan għandu jsir b' kawtela kbira.
Why has Prezista been approved?
Għaliex ġie approvat Prezista?
The Committee for Medicinal Products for Human Use (CHMP) decided that Prezista’ s benefits, when taken in combination with ritonavir and other antiretroviral medicinal products, were greater than its risks for the treatment of HIV-1 infection.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Mill- Bniedem (CHMP) iddeċieda li Prezista għandu iktar benefiċċji milli riskji meta użat flimkien ma 'ritonavir u sustanzi antiretrovirali oħra fit- trattament ta' pazjenti infettati bl- HIV1.
The Committee recommended that Prezista be given marketing authorisation.
Il- Kumitat irrakkomanda li Prezista jingħata awtorizzazzjoni għat - tqegħid fis- suq.
Prezista was originally given ‘ Conditional Approval’.
2/ 3 Prezista oriġinarjament ingħata ‘ Approvazzjoni Kondizzjonali ’.
This means that there was more evidence to come about the medicine, in particular its safety.
Dan ifisser li għad hemm iktar evidenza x’ tingħata dwar il- mediċina, b’ mod partikolari is- sigurtà tagħha.
As the company had supplied the additional information necessary, the authorisation was switched from ‘ conditional ’ to ‘ normal’ approval on 16 December 2008.
Peress li l- kumpanija forniet l- informazzjoni addizjonali neċessarja, l- awtorizzazzjoni nbidlet minn ‘ kondizzjoniali ’ għal ‘ normali ’ u ġiet approvata fis- 16 ta ’ Diċembru 2008.
2/ 3 Other information about Prezista:
Informazzjoni oħra dwar Prezista:
The European Commission granted a marketing authorisation valid throughout the European Union for Prezista to Janssen-Cilag International NV on 12 February 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha, għal Prezista lil Janssen- Cilag International NV fit- 12 ta ’ Frar 2007.
The full EPAR for Prezista can be found here.
L- EPAR sħiħ għal Prezista jista ’ jinstab hawnhekk.
EU Number EU/ 1/ 06/ 380/ 001 EU/ 1/ 06/ 380/ 002 EU/ 1/ 06/ 380/ 003
Numru ta ’ l- EU EU/ 1/ 06/ 380/ 001 EU/ 1/ 06/ 380/ 002 EU/ 1/ 06/ 380/ 003
Invented name Prezista Prezista Prezista
Isem ivvintat Prezista Prezista Prezista
Strength 300 mg 600 mg 400 mg
Qawwa 300 mg 600 mg 400 mg
Pharmaceutical Form Film-coated tablet Film-coated tablet Film-coated tablet
Għamla farmaċewtika pilloli miksijin b’ rita pilloli miksijin b’ rita pilloli miksijin b’ rita
Route of administration Oral use Oral use Oral use
Mnejn jingħata Użu orali Użu orali Użu orali
Package size 120 tablets 60 tablets 60 tablets
Daqs tal- pakkett 120 pilloli 60 pilloli 60 pilloli
PREZISTA 300 mg film-coated tablets.
PREZISTA 300 mg pilloli miksijin b’ rita.
Each film-coated tablet contains 300 mg of darunavir (as ethanolate).
Kull pillola miksija b’ rita fiha 300 mg ta ’ darunavir (bħala ethanolate).
Each tablet contains 1.375 mg sunset yellow FCF (E110).
Kull pillola fiha 1. 375 mg sunset yellow FCF (E110).
Orange oval shaped tablet, debossed with “ 300MG” on one side and “ TMC114” on the other side.
Pillola oranġjo b’ forma ovali, li fiha mħaffra “ 300MG ” fuq naħa waħda u “ TMC114 ” fuq in- naħa l - oħra.
PREZISTA, co-administered with 100 mg ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in treatment-experienced adult patients, including those that have been highly pre-treated.
PREZISTA, mogħti flimkien ma ’ 100 mg ritonavir huwa indikat, flimkien ma ’ prodotti mediċinali antiretrovirali oħra, għat- trattament ta ’ l- infezzjoni bil- virus uman ta ’ l- immunodefiċjenza (HIV- 1) f’ pażjenti adulti li diġà ħadu kura inkluż dawk li qabel kienu diġà ġew ikkurati ħafna.
In deciding to initiate treatment with PREZISTA co-administered with 100 mg 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 jinbeda trattament bi PREZISTA flimkien ma ’ 100 mg ritonavir għandha tittieħed wara li tingħata konsiderazzjoni għaqlija lill- istorja tat- trattament tal- pazjent individwali u l- mudelli ta ’ tibdiliet ġenetiċi assocjati ma ’ mediċini differenti.
Genotypic or phenotypic testing (when available) and treatment history should guide the use of PREZISTA.
Testijiet ġenotipiċi u finotipiċi (fejn disponibbli) u l- istorja tat- trattament għandhom iservu ta ’ gwida għall- użu ta ’ PREZISTA.
Therapy should be initiated by a physician experienced in the management of HIV infection.
It- terapija għandha tinbeda minn tabib li għandu esperjenza fil- mod kif jikkura l- infezzjoni ta ’ l- HIV.
PREZISTA must always be given orally with 100 mg ritonavir as a pharmacokinetic enhancer and in combination with other antiretroviral medicinal products.
PREZISTA għandu dejjem jingħata mill- ħalq flimkien ma 100 mg ritonavir li jservi ta ’ intensifikatur farmakokinetiku u flimkien ma ’ prodotti mediċinali antiretrovirali oħra.
The Summary of Product Characteristics of ritonavir must therefore be consulted prior to initiation of therapy with PREZISTA.
Is- Sommarju tal- Karatterisitċi tal- Prodott ta ’ ritonavir għandu għalhekk jiġi kkonsultat qabel ma ’ jinbeda trattament bi PREZISTA.
The recommended dosage of PREZISTA is 600 mg twice daily (b. i. d.) taken with ritonavir 100 mg b. i. d. and with food.
Id- doża rakkommandata ta ’ PREZISTA hija 600 mg darbtejn kuljum (b. i. d.) meħuda flimkien ma ’ ritonavir 100 mg b. i. d. u ma ’ l- ikel.
The type of food does not affect the exposure to darunavir (see sections 4.4, 4.5 and 5.2).
It- tip ta ’ ikel ma jaffettwax l- esponiment għal darunavir (ara sezzjonijiet 4. 4, 4. 5 u 5. 2).
PREZISTA is not recommended for use in children and adolescents because there are no data on safety, efficacy and pharmacokinetics.
PREZISTA mhux rakkomandat għall- użu fit- tfal u fl- adoloxxenti minħabba li m’ hemmx tagħrif dwar sigurtà, effikaċja u farmakokinetika.
Limited information is available in this population (see sections 4.4 and 5.2).
Informazzjoni limitata hija disponibbli f’ din il- popolazzjoni (ara sezzjonijiet 4. 4 and 5. 2).
Darunavir is metabolised by the hepatic system.
Darunavir huwa mmetabolizzat permezz tas- sistema epatika.
No dose adjustment is recommended in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment, however, PREZISTA should be used with caution in these patients.
Ma huwa rrakkomandat l- ebda aġġustament tad- doża f’ pazjenti b’ indeboliment epatiku ħafif (Child- Pugh Klassi A) jew moderat (Child- Pugh Klassi B), madankollu, PREZISTA għandu jintuża b’ attenzjoni f’ dawn il- pazjenti.
No pharmacokinetic data are available in patients with severe hepatic impairment.
L- ebda dejta farmakokinetika ma hija disponibbli f’ pazjenti b’ indeboliment epatiku serju.
Severe hepatic impairment could result in an increase of darunavir exposure and a worsening of its safety profile.
Indeboliment epatiku serju jista ’ jwassal għal esponiment ogħla għal darunavir u jġagħal il- profil ta’ sigurtà tiegħu jkompli jiħżien.
Therefore, PREZISTA should not be used in patients with severe hepatic impairment (Child-Pugh Class C) (see sections 4.3, 4.4 and 5.2).
Għalhekk, PREZISTA m’ għandux jintuża f’ pazjenti b’ indeboliment epatiku serju (Child- Pugh Klassi Ċ) (ara sezzjonijiet 4. 3, 4. 4 u 5. 2).
Renal impairment:
2 Indeboliment renali:
No dose adjustment is required in patients with renal impairment (see sections 4.4 and 5.2).
Ma hemm bżonn l- ebda aġġustament tad- doża f’ pazjenti b’ indeboliment renali serju (ara sezzjonijiet 4. 4 u 5. 2).
2 In case a dose of PREZISTA and/ or ritonavir was missed within 6 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of PREZISTA and ritonavir with food as soon as possible.
F’ każ li tinqabeż doża ta ’ PREZISTA u/ jew ritonavir fi żmien 6 sigħat minn meta din is- soltu tittieħed, il- pazjenti għandhom jiġu nfurmati biex jieħdu d- doża preskritta ta ’ PREZISTA u ritonavir ma ’ l- ikel malajr kemm jista ’ jkun.
If this was noticed later than 6 hours of the time it is usually taken, the missed dose should not be taken and the patient should resume the usual dosing schedule.
Jekk id- doża maqbuża tiġi nnutata wara li jgħaddu 6 sigħat minn meta tiġi meħuda s- soltu, id- doża maqbuża m’ għandiex tittieħed u l- pazjent għandu jkompli l- iskeda tad- dożi tas- soltu.
This guidance is based on the 15 hour half-life of darunavir in the presence of ritonavir and the recommended dosing interval of approximately 12 hours.
Din il- gwida hija bbażata fuq il- 15- il siegħa half life ta ’ darunavir fil- preżenza ta ’ ritonavir u l - intervall ta ’ bejn wieħed u ieħor 12- il siegħa li huwa rakkommandat li jinżamm bejn doża u oħra.
Patients with severe (Child-Pugh Class C) hepatic impairment.
Pazjenti b’ indeboliment epatiku serju (Child- Pugh Klassi Ċ).
Combination of rifampicin with PREZISTA with concomitant low dose ritonavir is contraindicated (see section 4.5).
L- għoti flimkien ta ’ rifampicin ma ’ PREZISTA ma ’ doża baxxa fl- istess ħin ta ’ ritonavir hu kontra - indikat (ara sezzjoni 4. 5).
The combination product lopinavir/ ritonavir should not be used with PREZISTA because co-administration causes large decreases in darunavir concentrations, which may in turn significantly decrease the darunavir therapeutic effect (see section 4.5).
Il- prodott li fih lopinavir u ritonavir flimkien m’ għandux jintuża flimkien ma PREZISTA minħabba li l- amministrazzjoni tagħhom flimkien toħloq tnaqqis kbir fil- konċentrazzjonijiet ta ’ darunavir, u konsegwenza ta ’ dan jonqos sinifikament l- effett terapewtiku ta ’ darunavir (ara sezzjoni 4. 5).
Herbal preparations containing St John’ s wort (Hypericum perforatum) must not be used while taking PREZISTA due to the risk of decreased plasma concentrations and reduced clinical effects of darunavir (see section 4.5).
Mediċini tal- ħxejjex li fihom St John’ s Wort (Hypericum perforatum) m’ għandhomx jintużaw waqt li qed jittieħed PREZISTA minħabba r- riskju ta ’ konċentrazzjonijiet imnaqqsa fil- plażma u tnaqqis fl - effetti kliniċi ta’ darunavir (ara sezzjoni 4. 5).
Co-administration of PREZISTA with 100 mg 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 flimkien ta ’ PREZISTA u 100 mg ritonavir, ma ’ sustanzi attivi li jiddependu ħafna minn CYP3A għat- tneħħija tagħhom u li l- konċentrazzjonijiet għoljin tagħhom fil- plażma huma assoċjati ma ’ ġrajjiet serji u/ jew ta ’ periklu għall- ħajja, huma kontra- indikati.
These active substances include e. g. antiarrhythmics (amiodarone, bepridil, quinidine, systemic lidocaine), antihistamines (astemizole, terfenadine), ergot derivatives (e. g. dihydroergotamine, ergonovine, ergotamine, methylergonovine), gastrointestinal motility agents (cisapride), neuroleptics (pimozide, sertindole), sedatives/ hypnotics (triazolam, midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5)) and HMG-CoA reductase inhibitors (simvastatin and lovastatin) (see section 4.5).
Dawn is- sustanzi attivi jinkludu e. ż. antiarritmiċi (amiodarone, bepridil, quinidine, lidocaine sistemiku), antistamini (astemizole, terfenadine), derivattivi ta ’ l- ergot (e. ż. dihydroergotamine, ergonovine, ergotamine, methylergonovine), aġenti tal- mobilità gastro- intestinali (cisapride), newrolettiċi (pimozide, sertindole), sedattivi/ ipnotiċi (triazolam, midazolam mogħti mill- ħalq (għal attenzjoni dwar midazolam li jingħata b’ mod parenterali, ara sezzjoni 4. 5)) u impedituri ta ’ l- HMG- CoA reductase (simvastatin u lovastatin) (ara sezzjoni 4. 5).
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 ’ tfejjaqx l- HIV u ma ’ kienetx ippruvata li twaqqaf l- HIV milli tiġi mgħoddija lil nies oħra permezz ta ’ dmija jew kuntatt sesswali.
PREZISTA should only be used in combination with 100 mg of ritonavir as a pharmacokinetic enhancer (see section 5.2).
PREZISTA għandu jintuża biss flimkien ma 100 mg ritonavir li jservi ta ’ intensifikatur farmakokinetiku (ara sezzjoni 5. 2).
Increasing the dose of ritonavir from that recommended in section 4.2 did not significantly affect darunavir concentrations and is not recommended.
Iż- żieda fid- doża ta ’ ritonavir minn dik rakkommandata f’ sezzjoni 4. 2 m’ affetwatx sinifikament il - konċentrazzjonijiet ta’ darunavir u m’ hijiex rakkommandata.
As limited information is available on the use of PREZISTA in patients aged 65 and over, caution should be exercised in the administration of PREZISTA in elderly patients, reflecting the greater frequency of decreased hepatic function and of concomitant disease or other therapy (see sections 4.2 and 5.2).
Minħabba li teżisti informazzjoni limitata dwar l- użu ta ’ PREZISTA f’ pazjenti li għandhom 65 sena jew aktar, għandu jkun hemm attenzjoni meta PREZISTA jiġi ammministrat lill- pazjenti anzjani, li tirrifletti il- frekwenza ogħla ta ’ funzjoni mnaqqsa tal- fwied u ta ’ mard konkomitanti jew terapiji oħra (ara sezzjonijiet 4. 2 u 5. 2).
Darunavir binds predominantly to α 1-acid glycoprotein.
Darunavir jeħel b’ mod predominanti ma ’ l- α1- glikoproteina aċida.
This protein binding is concentration dependent indicative for saturation of binding.
Għalhekk
Therefore, protein displacement of medicinal products highly bound to α 1-acid glycoprotein cannot be ruled out.
3 spostament ta ’ proteini ta ’ prodotti mediċinali li jeħlu ħafna ma ’ l- α1- glikoproteina aċida, ma tistax ma tikkunsidraħx.
Severe skin rash, which may be accompanied with fever and/ or elevations of transaminases, has occurred in 0.5% of patients treated with PREZISTA.
Raxx qawwi fil- ġilda, li jista ’ jseħħ flimkien ma ’ deni u/ jew livelli għoljin ta ’ transaminases, ġraw f’ 0. 5% tal- pazjenti kkurati bi PREZISTA.
Erythema multiforme and Stevens-Johnson
Eritema multiforme u s- Sindrome ta ’ Stevens- Johnson kienu osservati b’ mod rari (< 0. 1%).
Treatment with PREZISTA should be discontinued if such a condition develops.
Kura bi PREZISTA għandha titwaqqaf jekk tiżviluppa kundizzjoni bħal din.
Darunavir contains a sulphonamide moiety.
Darunavir għandu nofs attiv li huwa sulphonamide.
PREZISTA should be used with caution in patients with a known sulphonamide allergy.
PREZISTA għandu jintuża b’ attenzjoni f’ pazjenti li huma magħrufa li għandhom allerġija għal sulphonamide.
Patients with coexisting conditions Hepatic impairment The safety and efficacy of PREZISTA have not been established in patients with severe underlying liver disorders and PREZISTA is therefore contraindicated in patients with severe hepatic impairment.
Pazjenti b’ kundizzjonijiet ko- eżistenti Indeboliment epatiku Is- sigurtà u l- effikaċja ta ’ PREZISTA ma ’ ġewx stabbiliti f’ pazjenti b’ mard serju tal- fwied u għalhekk PREZISTA huwa kontra- indikat f’ pazjenti b’ indeboliment epatiku serju.
Due to an increase in the unbound darunavir plasma concentrations, PREZISTA should be used with caution in patients with mild or moderate hepatic impairment (see sections 4.2, 4.3 and 5.2).
Minħabba żieda fil - konċentrazzjonijiet ta ’ darunavir mhux imwaħħal mal- proteini fil- plażma, PREZISTA għandu jintuża b’ attenzjoni f’ pazjenti b’ indeboliment epatiku ħafif jew moderat (ara sezzjonijiet 4. 2, 4. 3 u 5. 2).
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 u li huma trattati b’ taħlita ta ’ għadd ta ’ terapiji antiretrovirali qegħdin f’ riskju akbar ta ’ effetti avversi epatiċi serji u li jistgħu jkunu fatali.
In case of concomitant antiviral therapy for hepatitis B or C, please refer to the relevant product information for these medicinal products.
F’ każ ta ’ terapija antivirali konkomitanti għall- epatite B u Ċ, jekk jogħġbok irreferti għall- informazzjoni rilevanti tal- prodott, għal dawn il- prodotti mediċinali.
Patients with pre-existing liver dysfunction including chronic hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Pazjenti li diġà għandhom il- fwied ma jaħdimx b’ mod normali inkluż epatite kronika għandhom frekwenza ogħla ta ’ abnormalitajiet tal- funzjoni tal- fwied waqt terapija b’ taħlita ta ’ għadd ta ’ mediċini antiretrovirali u għandhom ikunu segwiti skond il- prattika normali.
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment should be considered.
Jekk ikun hemm evidenza ta ’ mard tal- fwied li jmur għall- agħar f’ pazjenti bħal dawn, interruzzjoni jew waqfien mit- trattament għandu jiġi kkunsidrat.
Renal impairment No special precautions or dose adjustments are required in patients with renal impairment.
Indeboliment renali M’ hemm bżonn ta ’ l- ebda prekawzjonijiet speċjali jew aġġustament tad- doża f’ pazjenti b’ indeboliment renali.
As darunavir and ritonavir are highly bound to plasma proteins, it is unlikely that they will be significantly removed by haemodialysis or peritoneal dialysis.
Minħabba li darunavir u ritonavir jeħlu ħafna mal- proteini fil- plażma, huwa improbabbli li dawn jitneħħew b’ mod sinifikanti permezz tad- dijalisi tad- demm jew id- dijalisi tal - peritonew.
Therefore, no special precautions or dose adjustments are required in these patients (see sections 4.2 and 5.2).
Għalhekk m’ hemm bżonn ta ’ l- ebda prekawzjonijiet speċjali jew aġġustament tad- dożi f’ dawn il- pazjenti (ara sezzjonijiet 4. 2 u 5. 2).
Haemophiliac patients There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthrosis in patients with haemophilia type A and B treated with PIs.
Pazjenti morda bl- emofilja Kien hemm rapporti ta ’ żieda fil- fsada, inkluż ematomi spontanji fil- ġilda u emartrożi f’ pazjenti bl - emofilja tat- tip A u B trattati bl- Impedituri ta ’ Protease.
In some patients additional factor VIII was given.
F’ xi wħud mill- pazjenti żdiedet l- għotja tal - fattur VIII.
In more than half of the reported cases, treatment with PIs was continued or reintroduced if treatment had been discontinued.
F’ aktar minn nofs il- każi rrappurtati, trattament bl- Impedituri ta ’ Protease tkompla jew reġa ’ ġie mogħti jekk it- trattament twaqqaf.
A causal relationship has been suggested, although the mechanism of action has not been elucidated.
Kienet suġġerita relazzjoni kawżali, għalkemm il - mod ta ’ kif jaħdem għadu ma ġiex spjegat.
Haemophiliac patients should therefore be made aware of the possibility of increased bleeding.
Il- pazjenti morda bl- emofilja għandhom għalhekk ikunu jafu bil - possibbiltà ta ’ żieda fil- fsada.
Diabetes mellitus/ Hyperglycaemia New onset diabetes mellitus, hyperglycaemia, or exacerbation of existing diabetes mellitus has been reported in patients receiving antiretroviral therapy, including PIs.
Dijabete mellitus/ Ipergliċemija Dijabete mellitus li seħħet għall- ewwel darba, ipergliċemija, jew taħrix ta ’ djabete mellitus li kienet diġà teżisti ġew irrappurtati f’ pazjenti li qed jieħdu terapija antiretrovirali, inkluż l- Impedituri ta ’ Protease.
In some of these patients the hyperglycaemia was severe and in some cases also associated with ketoacidosis.
F’ xi wħud mill- pazjenti l- ipergliċemija kienet serja u f’ xi każijiet kienet ukoll assoċjata ma ’ ketoaċidożi.
Many patients had confounding medical conditions some of which required therapy with agents that have been associated with the development of diabetes mellitus or hyperglycaemia.
Ħafna mill- pazjenti kellhom kundizzjonijiet mediċi problematiċi li xi wħud minnhom kienu jinħtieġu terapija b’ mediċini li kienu assoċjati ma ’ l- iżvilupp ta ’ dijabete mellitus jew ipergliċemija.
Fat redistribution and metabolic disorders Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV infected patients.
Ridistribuzzjoni tax- xaħam u disturbi metaboliċi Terapija antiretrovirali b’ għadd ta ’ mediċini kienet assoċjata ma ’ ridistribuzzjoni tax- xaħam fil- ġisem (lipodistrofija) fil- pazjenti infettati bl- HIV.
The long-term consequences of these events are currently unknown.
Il- konsegwenzi fuq tul ta ’ żmien ta ’ dawn il- bidliet sal- lum għadhom m’ humiex magħrufa.
Knowledge about the mechanism is incomplete.
Għarfien dwar il- mekkaniżmu m’ huwiex komplut.
A connection between visceral lipomatosis and PIs and lipoatrophy and NRTIs has been hypothesised.
Ġiet ipotetizzata konnessjoni bejn lipomatożi tal- vixxri u l- Impedituri ta ’ Protease u l- lipoartrofija u l- NRTIs.
A higher risk of lipodystrophy has been associated with individual factors such as older age and with drug related factors such as longer duration of antiretroviral treatment and associated metabolic disturbances.
4 mediċini bħal- trattament aktar fit- tul b’ antiretrovirali u d- disturbi metaboliċi assoċjati magħhom.
Clinical examination should include evaluation for physical signs of fat redistribution.
Eżami kliniku għandu jinkludi evalwazzjoni għas- sinjali fiżiċi ta ’ ridistribuzzjoni tax- xaħam.
Consideration should be given to measurement of fasting serum lipids and blood glucose.
Għandha tingħata konsiderazzjoni lit- tiqjis ta ’ xaħmijiet fis- serum u zokkor fid- demm waqt is- sawm.
Lipid disorders should be managed as clinically appropriate (see section 4.8).
Id- disturbi tal- lipidi għandhom jiġu mmaniġġati skond kif inhu klinikament xieraq (ara sezzjoni 4. 8).
4 reported particularly in patients with advanced HIV disease and/ or long-term exposure to combination antiretroviral therapy (CART).
Osteonekrożi Għalkemm l- etjoloġija hija kkunsidrata li ġejja minn ħafna fatturi (inkluż l- użu ta ’ kortikosterojd, il - konsum ta ’ l- alkoħol, immunosoppressjoni serja, indiċi tal- massa tal- ġisem ogħla), każijiet ta ’ osteonekrożi ġew irrappurtati b’ mod partikolari f’ pazjenti bil- marda tal- HIV avvanzata u/ jew esponiment fit- tul għal terapija antiretrovirali b’ taħlita ta ’ għadd ta ’ mediċini (CART).
Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Il- pazjenti għandhom jiġu mwissija biex ifittxu parir mediku jekk ikollhom uġigħijat jew ebusija fil- ġogi, jew diffikultà fil- moviment.
Immune reactivation syndrome In HIV infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Sindrome tar- riativazzjoni immuni Fil- pażjenti infettati bl- HIV li jkollhom defiċjenza ta ’ l- immunità serja fiż- żmien meta jinbeda t - trattament antiretrovirali b’ għadd ta ’ mediċini (CART), tista ’ sseħħ reazzjoni infjammatorja għall - patoġeni li ma jurux sintomi jew opportunistiċi li jkun għad fadal li tikkawża kundizzjonijiet kliniċi serji jew sintomi li jaggravaw.
Typically, such reactions have been observed within the first weeks or months of initiation of CART.
Reazzjonijiet bħal dawn ġew osservati li jiġru b’ mod tipiku fl- ewwel ftit gimgħat jew xhur minn meta jibda CART.
Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterial infections and pneumonia caused by Pneumocystis jiroveci (formerly known as Pneumocystis carinii).
Eżempji rilevanti huma ċ- ċitomegalovirus retinite, infezzjonijiet mikobatterjali ġeneralizzati jew fokali u pnewmonja ikkawżata minn Pneumocystis jiroveci (li qabel kien magħruf bħala Pneumocystis carinii).
Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Kwalunkwe sintomi infjammtorji għandhom jiġu evalwati u għandu jinbeda trattament fejn hemm bżonn.
In addition, reactivation of herpes simplex and herpes zoster has been observed in clinical studies with PREZISTA co-administered with 100 mg ritonavir.
Flimkien ma dan, kienu nnutati r- riattivazzjoni ta ’ herpes simplex u herpes zoster fi studji kliniċi bi PREZISTA amministrat flimkien ma 100 mg ritonavir.
Interactions with medicinal products Several of the interaction studies have been performed at lower than recommended doses of darunavir.
Prodotti mediċinal li ma jaqblux ma ’ dan il- prodott Diversi mill- istudji ta ’ interazzjonijiet saru fuq doża ta ’ darunavir anqas minn dik rakkommandata.
The effects on co-administered medicinal products may thus be underestimated and clinical monitoring of safety may be indicated.
L - effetti fuq prodotti mediċinali amministrati flimkien jista ’ għalhekk ikun stmat anqas milli veru huwa u monitoraġġ kliniku tas- sigurtà jista ’ jkun indikat.
For full information on interactions with other medicinal products see section 4.5.
Għal informazzjoni sħiħa dwar prodotti mediċinali li ma jaqblux ma ’ dan il- prodott ara sezzjoni 4. 5.
PREZISTA tablets contain sunset yellow FCF (E110) which may cause an allergic reaction.
Il- pilloli PREZISTA fihom sunset yellow FCF (E110) li jista ’ jikkawża reazzjoni allerġika.
Darunavir and ritonavir are both inhibitors of the CYP3A4 isoform.
Darunavir u ritonavir it- tnejn huma impedituri ta ’ l- isoforma CYP3A4.
Co-administration of darunavir and ritonavir and medicinal products primarily metabolised by CYP3A4 may result in increased systemic exposure to such medicinal products, which could increase or prolong their therapeutic effect and adverse reactions.
L- amministrazzjoni flimkien ta ’ darunavir u ritonavir u prodotti mediċinali oħra primarjament metabolizzati minn CYP3A4 tista ’ tirriżulta f’ esponiment sistemiku ogħla għal mediċini bħal dawn, li jista ’ jżid jew itawwal l- effett terapewtiku u r- reazzjonijiet avversi.
PREZISTA co-administered with 100 mg ritonavir must not be combined with medicinal products that are highly dependent on CYP3A4 for clearance and for which increased systemic exposure is associated with serious and/ or life-threatening events (narrow therapeutic index).
PREZISTA amministrat flimkien ma ’ 100 mg ritonavir m’ għandhomx jingħataw flimkien ma ’ prodotti mediċinali li jiddependu ħafna minn CYP3A4 għat- tneħħija tagħhom u li liema żieda fl - esponiment sistemiku tagħhom huwa assoċjat ma ’ ġrajjiet serji u/ jew huwa ta ’ periklu għall- ħajja (indiċi terapewtiku strett).
These medicinal products include amiodarone, bepridil, quinidine, systemic lidocaine, astemizole, terfenadine, midazolam administered orally, triazolam, cisapride, pimozide, sertindole, simvastatin, lovastatin and the ergot alkaloids (e. g. ergotamine, dihydroergotamine, ergonovine and methylergonovine) (see section 4.3).
Dawn il- mediċini jinkludu amiodarone, bepridil, quinidine, lidocaine sistemiku, astemizole, terfenadine, midazolam mogħti mill- ħalq, triazolam, cisapride, pimozide, sertindole, simvastatin, lovastatin u l- alkalojdi ergot (e. ż. ergotamine, dihydroergotamine, ergonovine u methylergonovine) (ara sezzjoni 4. 3).
The overall pharmacokinetic enhancement effect by ritonavir was an approximate 14-fold increase in the systemic exposure of darunavir when a single dose of 600 mg darunavir was given orally in combination with ritonavir at 100 mg b. i. d.
L- effett totali ta ’ l- intensifikazzjoni ta ’ l- effett farmakokinetiku permezz ta ’ ritonavir kien bejn wieħed u ieħor żieda ta ’ 14- il darba fl- esponimnet sistemiku ta ’ darunavir meta doża waħda ta ’ 600 mg darunavir ingħatat mill- ħalq flimkien ma ’ ritonavir 100 mg b. i. d.
Therefore, PREZISTA must only be used in combination with 100 mg of ritonavir as a pharmacokinetic enhancer (see sections 4.4 and 5.2).
Għalhekk PREZISTA għandu jintuża biss flimkien ma ’ 100 mg ritonavir biex jintensifika l- effett farmakokinetiku (ara sezzjonijiet 4. 4 u 5. 2).
A clinical study utilising a cocktail of drugs that are metabolised by cytochromes CYP2C9, CYP2C19 and CYP2D6 demonstrated an increase in CYP2C9 and CYP2C19 activity and inhibition of CYP2D6 activity in the presence of PREZISTA/ rtv, which may be attributed to the presence of low dose ritonavir.
L -
Co-administration of darunavir and ritonavir and medicinal products which are primarily metabolised by CYP2D6 (such as flecainide, propafenone, metoprolol) may result in increased plasma concentrations of these medicinal products, which could increase or prolong their therapeutic effect and adverse reactions.
5 amministrazzjoni ta ’ darunavir flimkien ma ’ ritonavir u ma ’ prodotti mediċinali li huma primarjament immetabolizzati minn CYP2D6 (bħal flecainide, propafenone, metoprolol) tista ’ twassal għal żieda ta ’ konċentrazzjonjiet fil- plażma ta ’ dawn il- prodotti mediċinali, li jistgħu jżidu jew itawwlu l- effett terapewtiku tagħhom u r- reazzjonijiet avversi.
Co-administration of darunavir and ritonavir and medicinal products primarily metabolised by CYP2C9 (such as warfarin) and CYP2C19 (such as methadone) may result in decreased systemic exposure to such medicinal products, which could decrease or shorten their therapeutic effect.
L- amministrazzjoni ta ’ darunavir flimkien ma ’ ritonavir u ma ’ prodotti mediċinali primarjament immetabolizzati minn CYP2C9 (bħal warfarin) u CYP2C19 (bħal methadone) tista ’ twassal għal esponiment sistemiku mnaqqas għal dawn il- prodotti mediċinali, li jista ’ jnaqqas jew iqassar l- effett terapewtiku tagħhom.
Although the effect on CYP2C8 has only been studied in vitro, co-administration of darunavir and ritonavir and medicinal products primarily metabolised by CYP2C8 (such as paclitaxel, rosiglitazone, repaglinide) may result in decreased systemic exposure to such medicinal products, which could decrease or shorten their therapeutic effect.
Għalkemm l- effett fuq CYP2C8 ġie studjat biss in vitro, l- amministrazzjoni ta ’ darunavir flimkien ma ritonavir u prodotti mediċinali primarjament immetabolizzati minn CYP2C8 (bħal paclitaxel, rosiglitazone, repaglinide) tista ’ tirriżulta f’ esponiment sistemiku mnaqqas għal dawn il- prodotti mediċinali, li jista ’ jnaqqas jew iqassar l- effett terapewtiku tagħhom.
5 Medicinal products that affect darunavir/ ritonavir exposure Darunavir and ritonavir are metabolised by CYP3A.
Prodotti mediċinali li jaffettwaw l- esponiment ta ’ darunavir/ ritonavir Darunavir u ritonavir huma metabolizzati permezz ta ’ CYP3A.
Medicinal products that induce CYP3A activity would be expected to increase the clearance of darunavir and ritonavir, resulting in lowered plasma concentrations of darunavir and ritonavir (e. g. rifampicin, St John’ s wort, lopinavir).
Prodotti mediċinali li jinduċu l- attività ta ’ CYP3A jkunu mistennija li jżidu t- tneħħija ta ’ darunavir u ritonavir bir- riżultat ta ’ konċentrazzjonijiet imnaqqsa ta ’ darunavir u ritonavir fil- plażma (e. ż. rifampicin, St John’ s wort, lopinavir).
Co-administration of darunavir and ritonavir and other medicinal products that inhibit CYP3A may decrease the clearance of darunavir and ritonavir and may result in increased plasma concentrations of darunavir and ritonavir (e. g. indinavir, systemic azoles like ketoconazole and clotrimazole).
L- amministrazzjoni ta ’ darunavir u ritonavir flimkien ma ’ prodotti mediċinali oħra li jimpedixxu CYP3A jistgħu jnaqqsu t- tneħħija ta ’ darunavir u ritonavir u jistgħu jwasslu għal konċentrazzjonijiet ogħla ta ’ darunavir u ritonavir fil- plażma (e. ż. indinavir, azoles sistemiċi bħal ketoconazole u clotrimazole).
These interactions are described in the interaction tables below.
Dawn l- interazzjonijiet huma deskritti fit- tabelli hawn taħt.
Interaction table Interactions between darunavir/ ritonavir and protease inhibitors, antiretroviral agents other than protease inhibitors and other non-antiretroviral medicinal products are listed in the tables below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, not determined as “ ND”, twice daily as “ b. i. d.”, once daily as “ q. d.” and once every other day as “ q. o. d.”).
Tabella ta ’ prodotti mediċinali li ma jaqblux flimkien Interazzjonijiet bejn darunavir/ ritonavir u Impedituri ta ’ Protease, mediċini antiretrovirali li ma humiex Impedituri ta ’ Protease u prodotti mediċinali oħrajn li ma humiex antiretrovirali huma elenkati fit- tabelli t’ hawn taħt (żieda hija indikata bħala “ ↑ ”, tnaqqis bħala “ ↓ ”, l- ebda bidla bħala “ ↔ ”, ma tistax tittieħed stima bħala “ ND ”, darbtejn kuljum bħala “ b. i. d. ”, darba kuljum bħala “ q. d. ” u ġurnata iva u oħra le bħala “ q. o. d. ”).
Several of the interaction studies (indicated by # in the table below) have been performed at lower than recommended doses of darunavir or with a different dosing regimen (see section 4.2 Posology).
Diversi mill- istudji ta ’ prodotti mediċinali li ma jaqblux mal- prodott (indikati b ’ # tabella hawn taħt) saru b’ dożi ta ’ darunavir anqas minn dawk irrakkommandati jew b’ għoti tad- doża b’ mod differenti (ara sezzjoni 4. 2 Pożoloġija).
The effects on co-administered medicinal products may thus be underestimated and clinical monitoring of safety may be indicated.
L- effetti fuq prodotti mediċinali amministrati flimkien jista ’ għalhekk ikun stmat anqas milli veru huwa u monitoraġġ kliniku tas- sigurtà jista ’ jkun indikat.
Interactions – Darunavir/ ritonavir with Protease Inhibitors The efficacy and safety of the use of PREZISTA with 100 mg ritonavir and any other PI (e. g.
Interazzjonijiet – Darunavir/ ritonavir ma ’ Impedituri ta ’ Protease L- effikaċja u s- sigurtà ta ’ l- użu ta ’ PREZISTA ma ’ 100 mg ritonavir u kwalunkwe Impeditur ta ’ Protease ieħor (e. ż.
(fos)amprenavir, nelfinavir and tipranavir) has not been established in HIV patients.
(fos) amprenavir, nelfinavir u tipranavir) ma ’ ġewx stabbiliti f’ pazjenti ta ’ l- HIV.
Generally, dual therapy with protease inhibitors is not recommended.
Ġeneralment terapija doppja b’ Impedituri ta ’ Protease m’ hijiex rakkommandata.
Co-administered
Doża tal- Prodott
Dose of Dose of
Prodott Mediċinali Doża tal- Prodott Doża ta ’ Prodott
Medicinal Product
Amministrat
Co-administered
Mediċinali
Product
Mediċinali
Medicinal Product (mg)
Amministrat
Assessed
Eżaminat
1,200/ 100 b. i. d.
1, 200/ 100 b. i. d.
533/133.3 b.i.d.
533/ 133. 3 b. i. d.
1,200 b.i.d.
1, 200 b. i. d.
* based upon not dose normalised values Due to a decrease in the exposure (AUC) of darunavir by 40%, appropriate doses of the combination have not been established.
* ibbażati fuq valuri mhux normalizzati tad- doża Minħabba t- tnaqqis fl- esponiment (AUC) ta ’ darunavir b’ 40%, dożi xierqa tagħhom flimkien ma ġewx stabbiliti.
Hence, concomitant use of PREZISTA co-administered with 100 mg ritonavir and the combination product lopinavir/ritonavir is contraindicated (see section 4.3).
Għalhekk l- amministrazzjoni konkomitanti ta ’ PREZISTA amministrat flimkien ma ’ 100 mg ritonavir mal- prodott li fih lopinavir u ritonavir hija kontra- indikata (ara sezzjoni 4. 3).
1,000 b.i.d.
400/ 100 b. i. d. #
The study with boosted saquinavir showed no significant effect of darunavir on saquinavir.
L- istudju b’ saquinavir imsaħħaħ ma wera l- ebda effett sinifikanti ta ’ darunavir fuq saquinavir.
It is not recommended to combine PREZISTA co-administered with 100 mg ritonavir with saquinavir.
L- amministrazzjoni ta ’ saquinavir flimkien ma ’ PREZISTA amministrat ma ’ 100 mg ritonavir m’ hijiex rakkomandata.
When used in combination with PREZISTA co-administered with 100 mg ritonavir, dose adjustment of indinavir from 800 mg b.i.d. to 600 mg b.i.d. may be warranted in case of intolerance.
Darunavir Meta użat flimkien ma ’ PREZISTA amministrat ma ’ 100 mg ritonavir, jista ’ jkun hemm bżonn ta ’ aġġustament tad- doża ta ’ indinavir minn 800 mg b. i. d. għal 600 mg b. i. d f’ każ ta ’ intolleranza.
Atazanavir
6 Atazanavir
Darunavir
↔ ↔
Darunavir/ritonavir did not significantly affect atazanavir exposure, however 90% CI for Cmin were 99-234%.
Darunavir/ ritonavir ma affetwawx sinifikament l- esponiment għal atazanavir madanakollu, 90% CI għal Cmin kien ta ’ 99 – 234%.
Atazanavir can be used with PREZISTA co-administered with 100 mg ritonavir.
Atazanavir jista ’ jintuża ma ’ PREZISTA amministrat flimkien ma ’ 100 mg ritonavir.
Interactions – Darunavir/ritonavir with Antiretroviral Agents other than Protease Inhibitors Co-administered
Interazzjonijiet – Darunavir/ ritonavir ma ’ Mediċini Antiretrovirali li ma humiex Impedituri ta ’ Protease Prodott Mediċinali
Dose of Dose of
Doża tal- Prodott
Medicinal
Doża t
Efavirenz
Flimkien Miegħu (mg) Efavirenz
300/100 b.i.d.# Efavirenz
Efavirenz Darunavir
6 Efavirenz decreases the plasma concentrations of darunavir as a result of CYP3A4 induction.
Efavirenz inaqqas il- konċentazzjonijiet ta ’ darunavir fil- plażma minħabba induzzjoni ta ’ CYP3A4.
Darunavir/ritonavir increases the plasma concentrations of efavirenz as a result of CYP3A4 inhibition.
Darunavir/ ritonavir iżidu il- konċentrazzjonijiet ta ’ efavirenz fil- plażma minħabba impediment ta ’ CYP3A4.
Clinical monitoring for central nervous system toxicity associated with increased exposure to efavirenz may be indicated when PREZISTA co-administered with 100 mg ritonavir is given in combination with efavirenz.
Monitoraġġ kliniku għal tossiċità tas- sistema ċentrali nervuża assoċjata ma ’ żieda fl- espożizzjoni għal efavirenz jista ’ jkun indikat meta PREZISTA amministrat ma 100 mg ritonavir jingħataw flimkien ma ’ efavirenz.
Etravirine
Etravirine Darunavir
* dose used in drug-interaction study.
* id- doża wżata fl- istudju dwar interazzjoni bejn mediċini.
For recommended dose see paragraph below.
Għad- doża rakkomandata ara l- pragrafu t’ hawn taħt.