qanastek/EMEA-V3 huggingface dataset:
It must not be used in patients with severe liver disease or who are taking any of the following medicines:  astemizole, terfenadine (commonly used to treat allergy symptoms - these medicines may be available without prescription);  dihydroergotamine, ergotamine, ergonovine, methylergonovine (used to treat migraine headache);  midazolam, triazolam (used to relieve anxiety or difficulty sleeping);  pimozide (used to treat mental illnesses);  cisapride (used to relieve certain stomach problems);  bepridil (used to treat angina);  St John ’ s wort (a herbal preparation used to treat depression).
Ma għandux jintuża f’ pazjenti b’ mard gravi tal- fwied jew li qed jieħdu waħda minn dawn il- mediċini li ġejjin:  astemizole, terfenadina (terfenadine) (użati komunement għat- trattament tas- sintomi allerġiċi - dawn il- mediċini jistgħu jkunu disponibbli mingħajr riċetta);  diidroergotamina (dihydroergotamine), ergotamina (ergotamine), ergonovina (ergonovine) u metilergonovina (methylergonovine) (użati fit- trattament tal- emikranja);  midazolam, triazolam (użati biex itaffu l- ansjetà jew diffikultà fl- irqad),  pimozide (użat għat- trattament ta ’ mard mentali);  cisapride (użat biex itaffi ċerti problemi tal- istonku);  bepridil (użat għat- trattament tal- anġina);  fexfiex tar- raba ’ (St John’ s wort) (preparazzjoni tal- ħxejjex użata fit- trattament tad- depressjoni).
Caution is also needed when Stocrin is taken at the same time as other medicines.
Meta Stocrin jingħata fl- istess ħin ma ’ mediċini oħra hija meħtieġa l- kawtela.
As with other anti-HIV medicines, patients taking Stocrin 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 għal mediċini oħra ta ’ kontra l- HIV, il- pazjenti ttrattati bi Stocrin jista ’ jkollhom riskju ta ’ lipodistrofija (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 an elevated risk of liver damage when taking Stocrin.
Il- pazjenti li jkollhom problemi bil- fwied (inklużi infezzjonijiet tal - epatite B jew Ċ) jistgħu jkunu esposti aktar għar- riskju li jiżviluppaw ħsara fil- fwied jekk ittrattati bi Stocrin.
2/ 3 Why has Stocrin been approved?
2/ 3 Għaliex ġie approvat Stocrin?
The Committee for Medicinal Products for Human Use (CHMP) decided that Stocrin’ s benefits are greater than its risks in antiviral combination treatment of HIV-infected adults, adolescents, and children three years of age and older.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Stocrin huma ogħla mir- riskji tiegħu fit- trattament antivirali kkombinat ta ’ adulti, adolexxenti u tfal ta ’ età ‘ l fuq minn tliet snin b’ infezzjoni mill- HIV.
The Committee noted that Stocrin has not been studied adequately in patients with advanced disease (CD4 cell counts below 50 cells/ mm3) or after treatment with protease inhibitors (another type of antiviral medicine) that was not working.
Il- Kumitat innota li Stocrin ma ġiex studjat biżżejjed fil- pazjenti f’ fażi avvanzata tal- marda (b’ għadd ta ’ ċelloli CD4 inqas minn 50 ċellola/ mm3) jew li fihom, it- trattament b’ inibituri tal- proteażi (tip ta ’ mediċina antivirali oħra) ma ħadimx.
The Committee also noted that there is little information on the benefits of treatment including a protease inhibitor in patients who have been treated with Stocrin in the past but which stopped working, although there is no evidence to suggest that protease inhibitors may not work in these patients.
Il- Kumitat innota wkoll li l- informazzjoni attwalment disponibbli mhijex biżżejjed biex tivvaluta l- benefiċċji ta ’ trattamenti li jinkludu inibitur tal- proteażi użati wara l- falliment ta ’ terapija bi Stocrin, minkejja ma hemmx provi biex isostnu li f’ dawn il- pazjenti l- inibituri tal- proteażi mhumiex effikaċi.
The Committee recommended that Stocrin be given marketing authorisation.
Il- Kumitat irrakkomanda li Stocrin jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Stocrin:
Aktar tagħrif dwar Stocrin:
The European Commission granted a marketing authorisation valid throughout the European Union for Stocrin to Merck Sharp & Dohme Limited on 28 May 1999.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Stocrin lil Merck Sharp & Dohme Limited fit- 28 ta ’ Mejju 1999.
The marketing authorisation was renewed on 28 May 2004 and on 28 May 2009.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fit- 28 ta ’ Mejju 2004 u fit- 28 ta ’ Mejju 2009.
The full EPAR for Stocrin can be found here.
L- EPAR sħiħ għal Stocrin jista ’ jiġi kkonsultat hawn.
This summary was last updated in 05-2009.
Dan is- sommarju kien aġġornat l- aħħar fi:
STOCRIN 50 mg hard capsules
STOCRIN 50 mg kapsuli ibsin
Each hard capsule contains 50 mg of efavirenz.
Kull kapsula iebsa fiha 50 mg ta ’ efavirenz.
Excipient: each hard capsule contains 28.5 mg of lactose monohydrate.
Sustanza mhux attiva: kull kapsula iebsa fiha 28. 5 mg ta ’ lactose monohydrate.
For a full list of excipients, see section 6.1.
Għal- lista sħiħa ta ’ sustanzi mhux attivi, ara Sezzjoni 6. 1.
Dark yellow and white, printed with “ 3805”.
Sofor skuri u bojod, stampati bi ” 3805 ”.
STOCRIN is indicated in antiviral combination treatment of human immunodeficiency virus-1 (HIV-1) infected adults, adolescents and children 3 years of age and older.
4. 1 Indikazzjonijiet terapewtiċi
STOCRIN has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/ mm3, or after failure of protease inhibitor (PI) containing regimens.
STOCRIN ma ġiex studjat b’ mod adegwat f’ pazjenti b’ mard avvanzat ta ’ l- HIV, u speċifikament pazjenti b’ għadd CD4 < 50 ċellula/ mm3, jew wara li jkunu fallew kuri li jkun fihom l- impeditur ta ’ protease (PI).
Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI based combination therapy after failure of regimens containing STOCRIN.
Ghalkemm ir- reżistenza msallba ta ’ efavirenz ma ’ PIs ma ġietx dokumentata, fil- preżent m’ hemmx biżżejjed tagħrif dwar l- effikaċja ta ’ l- użu tal- kura kombinata bbażata fuq PI wara li jkunu fallew il- kuri li fihom STOCRIN.
For a summary of clinical and pharmacodynamic information, see section 5.1.
Għal taqsira ta ’ l- informazzjoni klinika u farmakodinamika, ara sezzjoni 5. 1.
Therapy should be initiated by a physician experienced in the management of HIV infection.
It- terapija għandha tinbeda minn tabib b’ esperjenza fl- immaniġġjar ta ’ l- infezzjoni ta ’ l- HIV.
Concomitant antiretroviral therapy:
Terapija antiretrovirali kombinata:
STOCRIN must be given in combination with other antiretroviral medicines (see section 4.5).
STOCRIN irid jingħata flimkien ma ’ mediċini oħra antiretrovirali (ara sezzjoni 4. 5).
It is recommended that STOCRIN be taken on an empty stomach.
Huwa rakkomandat li STOCRIN jittieħed fuq stonku vojt.
The increased efavirenz concentrations observed following administration of STOCRIN with food may lead to an increase in frequency of adverse reactions (see sections 4.4 and 5.2).
Il- konċentrazzjonijiet ogħla ta ’ efavirenz li ġew osservati wara l- għoti ta ’ STOCRIN ma ’ l- ikel jistgħu jwasslu għal żieda fil- frekwenza tar - reazzjonijiet mhux mixtieqa (ara sezzjonijiet 4. 4 u 5. 2).
In order to improve the tolerability of nervous system undesirable effects, bedtime dosing is recommended (see section 4.8).
(ara sezzjoni 4. 8).
Adults: the recommended dosage of STOCRIN in combination with nucleoside analogue reverse transcriptase inhibitors (NRTIs) with or without a PI (see section 4.5) is 600 mg orally, once daily.
Id- doża rakkomandata ta ’ STOCRIN flimkien ma ’ nucleoside analogue reverse transcriptase inhibitors (NRTIs) flimkien ma ’ PIs jew mingħajrhom (ara sezzjoni 4. 5) hija ta ’ 600 mg kuljum, darba kuljum.
Paediatric patients (3 to 17 years): the recommended dose of STOCRIN in combination with a PI and/ or NRTIs for patients between 3 and 17 years of age is described in Table 1.
Pazjenti pedjatriċi (minn 3 sa 17- il sena): id- doża rakkomandata ta ’ STOCRIN flimkien ma ’ PI u/ jew NRTIs għal pazjenti bejn it- 3 u s- 17- il sena hija deskritta f’ Tabella 1.
STOCRIN hard capsules must only be administered to children who are able to reliably swallow hard capsules.
Il- kapsuli ibsin ta ’ STOCRIN għandhom jinghataw biss lit- tfal li żgur jistgħu jibilgħu l- kapsuli ibsin.
2 STOCRIN is not recommended for use in children below the age of 3 years or weighing less than 13 kg due to a lack of data on safety and efficacy in that age group (see sections 5.1 and 5.2).
2 STOCRIN mhux rakkomandat għal tfal taħt l- eta` tat- 3 snin jew fi tfal li jiżnu inqas minn 13- il kg minħabba n- nuqqas ta ’ tagħrif dwar is- sigurtà u l- effikaċja f’ dan il- grupp (ara sezzjonijiet 5. 1 u 5. 2).
Table 1 Paediatric dose to be administered once daily
Tabella 1 Doża għat- tfal li għandha tingħata darba kuljum
Body Weight kg 13 to < 15 15 to < 20 20 to < 25 25 to < 32.5 32.5 to < 40 ≥ 40
Piż tal- ġisem kg 13 sa < 15 15 sa < 20 20 sa < 25 25 sa < 32. 5 32. 5 sa < 40 ≥ 40
STOCRIN Dose (mg) 200 250 300 350 400 600
STOCRIN Doża (mg) 200 250 300 350 400 600
Dosage adjustment: if STOCRIN is coadministered with voriconazole, the voriconazole maintenance dose must be increased to 400 mg every 12 hours and the STOCRIN dose must be reduced by 50%, i. e., to 300 mg once daily.
Aġġustament fid- dożaġġ: jekk STOCRIN jingħata flimkien ma ’ voriconazole, id- doża ta ’ manteniment ta ’ voriconazole għandha tiżdied sa 400 mg kull 12- il siegħa u d- doża ta ’ STOCRIN għandha titnaqqas b’ 50%, jiġifieri għal 300 mg darba kuljum.
When treatment with voriconazole is stopped, the initial dosage of efavirenz should be restored (see section 4.5).
Meta t- trattament b’ voriconazole jitwaqqaf, għandha terġa ’ tibda tingħata d- doża inizjali ta ’ efavirenz (ara sezzjoni 4. 5).
If STOCRIN is coadministered with rifampicin, an increase in the dose of STOCRIN to 800 mg/ day may be considered (see section 4.5).
Jekk STOCRIN jingħata flimkien ma ’ rifampicin, tista ’ tiġi kkunsidrata żieda fid- doża ta ’ STOCRIN għal 800 mg/ kuljum (ara sezzjoni 4. 5).
Renal impairment: the pharmacokinetics of efavirenz have not been studied in patients with renal insufficiency; however, less than 1% of an efavirenz dose is excreted unchanged in the urine, so the impact of renal impairment on efavirenz elimination should be minimal (see section 4.4).
(ara sezzjoni 4. 4).
Hepatic impairment: patients with mild to moderate liver disease may be treated with their normally recommended dose of efavirenz.
Indeboliment fil- fwied: pazjenti li għandhom mard minn ħafif sa moderat fil- fwied jistgħu jiġu kkurati bid- doża rakkomandata normalment ta ’ efavirenz.
Patients should be monitored carefully for dose-related adverse reactions, especially nervous system symptoms (see sections 4.3 and 4.4).
Il- pazjenti jridu jkunu monitorjati b’ attenzjoni għal reazzjonijiet avversi marbuta mad- doża, speċjalment sintomi tas- sistema nervuża (ara sezzjonijiet 4. 3 u 4. 4).
Hypersensitivity to the active substance or to any of the excipients.
Sensittivita` eċċessiva għas- sustanza attiva jew għal xi waħda mis- sustanzi mhux attivi.
Efavirenz must not be used in patients with severe hepatic impairment (Child Pugh Grade C) (see section 5.2).
Efavirenz m’ għandux jintuża minn pazjenti b’ indeboliment sever tal- fwied (Grad Child Pugh C) (ara sezzjoni 5. 2).
Efavirenz must not be administered concurrently with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, or ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) because competition for CYP3A4 by efavirenz could result in inhibition of metabolism and create the potential for serious and/ or life-threatening undesirable effects [for example, cardiac arrhythmias, prolonged sedation or respiratory depression] (see section 4.5).
[ngħidu aħna, arritmiji kardijaċi, sedazzjoni fit- tul jew depressjoni respiratorja] (ara sezzjoni 4. 5).
John’ s wort (Hypericum perforatum) must not be used while taking efavirenz due to the risk of decreased plasma concentrations and reduced clinical effects of efavirenz (see section 4.5).
Waqt li qed jintuża efavirenz m’ għandhomx jintużaw preparazzjonijiet ta ’ ħxejjex li fihom il- fexfiex tar- raba ’ (Hypericum perforatum) minħabba li joktor ir- riskju ta ’ konċentrazzjonijiet imnaqqsa fil - plażma u ta ’ effetti kliniċi mnaqqsa ta ’ efavirenz (ara sezzjoni 4. 5).
Efavirenz must not be used as a single agent to treat HIV or added on as a sole agent to a failing regimen.
Efavirenz m’ għandux jintuża waħdu biex jikkura l- HIV, l- anqas m’ għandu jiżdied waħdu f’ kura li qed tfalli.
As with all other non-nucleoside reverse transcriptase inhibitors (NNRTIs), resistant virus emerges rapidly when efavirenz is administered as monotherapy.
Bħal ma ’ non- nucleoside reverse transcriptase inhibitors (NNRTIs), meta efavirenz jiġi amministrat waħdu malajr joħroġ virus reżistenti għalih.
The choice of new antiretroviral agent(s) to be used in combination with efavirenz should take into consideration the potential for viral cross-resistance (see section 5.1).
3 jintużaw flimkien ma ’ efavirenz għandha tqis il- potenzjali ta ’ reżistenza msallba virali (ara sezzjoni 5. 1).
3 Co-administration of efavirenz with the fixed combination tablet containing efavirenz, emtricitabine, and tenofovir disoproxil fumarate, is not recommended.
L- għoti flimkien ta ’ efavirenz mal- pillola ta ’ kombinazzjoni fissa li fiha efavirenz, emtricitabine, u tenofovir disoproxil fumarate, mhuwiex rakkomandat.
When prescribing medicinal products concomitantly with STOCRIN, physicians should refer to the corresponding Summary of Product Characteristics.
Meta jiġu preskritti prodotti mediċinali flimkien ma ’ STOCRIN, it- tobba għandhom jirreferu għall - Karatteristiċi tal- Prodott fil- Qosor korrispondenti.
Patients should be advised that current antiretroviral therapy, including efavirenz, has not been proven to prevent the risk of transmission of HIV to others through sexual contact or blood contamination.
Il- pazjenti għandhom ikunu mgħarrfa li t- terapija antiretrovirali li hemm bħalissa, inkluż efavirenz, ma ġietx ippruvata li timpedixxi r- riskju tat- trażmissjoni ta ’ l- HIV lil nies oħrajn permezz ta ’ kuntatt sesswali jew kontaminazzjoni tad- demm.
Appropriate precautions should continue to be employed.
Għandhom jittieħdu l- prekawzjonijiet xierqa.
If any antiretroviral medicinal product in a combination regimen is interrupted because of suspected intolerance, serious consideration should be given to simultaneous discontinuation of all antiretroviral medicinal products.
Jekk xi prodott mediċinali antiretrovirali f’ kura kombinata jitwaqqaf minħabba suspett ta ’ intolleranza, għandha titqies bis- serjeta` l- possibilita` li jitwaqqfu flimkien il- prodotti mediċinali kollha antiretrovirali.
The antiretroviral medicinal products should be restarted at the same time upon resolution of the intolerance symptoms.
Il- prodotti mediċinali antiretrovirali għandhom jerġgħu jibdew jittieħdu fl- istess ħin ladarba s- sintomi ta ’ l- intoleranza jgħaddu.
Intermittent monotherapy and sequential reintroduction of antiretroviral agents is not advisable because of the increased potential for selection of resistant virus.
Mhux ta ’ min isiru terapija mhux kontinwa b’ mediċina waħda u l- introduzzjoni mill- ġdid f’ sekwenza ta ’ aġenti antiretrovirali minħabba r- riskju ikbar tas - selezzjoni ta ’ virus reżistenti.
Rash: mild-to-moderate rash has been reported in clinical studies with efavirenz and usually resolves with continued therapy.
Ġie rraportat raxx minn ħafif sa moderat fi studju kliniċi b’ efavirenz, u s- soltu jgħaddi mat - tkomplija tat- terapija.
Appropriate antihistamines and/ or corticosteroids may improve the tolerability and hasten the resolution of rash.
Anti- istaminiċi u/ jew kortikosterojdi xierqa jistgħu itejbu t- tollerabilita` u jgħinu biex ir- raxx jgħaddi iktar malajr.
Severe rash associated with blistering, moist desquamation or ulceration has been reported in less than 1% of patients treated with efavirenz.
Ġie rrapurtat raxx qawwi marbut ma ’ nfafet, tqaxxir umdu tal - ġilda u ulċeri f’ inqas minn 1% mill- pazjenti kkurati b’ efavirenz.
The incidence of erythema multiforme or Stevens-Johnson syndrome was approximately 0.1%.
L- inċidenza ta ’ eritema multiforme jew is- sindromu ta ’ Stevens- Johnson kien ta ’ bejn wieħed u ieħor 1%.
Efavirenz must be discontinued in patients developing severe rash associated with blistering, desquamation, mucosal involvement or fever.
Efavirenz għandu jitwaqqaf f’ pazjenti li jiżviluppaw raxx qawwi marbut ta ’ nfafet, tqaxxir tal- ġilda, involvement tal- mukożi jew deni.
If therapy with efavirenz is discontinued, consideration should also be given to interrupting therapy with other antiretroviral agents to avoid development of resistant virus (see section 4.8).
Jekk titwaqqaf it- terapija b’ efavirenz, għandha titqies il- possibilita` li tiġi interrotta t- terapija b’ aġenti antiretrovirali oħra biex ma jiżviluppax virus reżistenti (ara sezzjoni 4. 8).
Rash was reported in 26 of 57 children (46%) treated with efavirenz during a 48-week period and was severe in three patients.
Ġie rrapurat raxx f’ 26 minn 57 tifel u tifla (46%) li ġew ikkurati b’ efavirenz waqt perjodu ta ’ 48 ġimgħa, u kien qawwi fi tliet pazjenti.
Prophylaxis with appropriate antihistamines prior to initiating therapy with efavirenz in children may be considered.
Fit- tfal għandu jitqies l- użu ta ’ anti- istaminiċi xierqa bħala prevenzjoni qabel ma tinbeda l- kura b’ efavirenz.
Patients who discontinued treatment with other NNRTIs due to rash may be at higher risk of developing rash during treatment with efavirenz.
Pazjenti li ma komplewx il- kura b’ NNRTIs oħra minħabba raxx jista ’ jkollhom riskju ikbar li jiżviluppaw raxx waqt il- kura b’ efavirenz.
Psychiatric symptoms: psychiatric adverse reactions have been reported in patients treated with efavirenz.
F’ pazjenti kkurati b’ efavirenz ġew irrapurtati reazzjonijiet avversi psikjatriċi.
Patients with a prior history of psychiatric disorders appear to be at greater risk of these serious psychiatric adverse reactions.
Pazjenti li għandhom storja medika minn qabel ta ’ mard psikjatriku jidhru li għandhom riskju ikbar ta ’ reazzjonijiet psikjatriċi avversi serji.
In particular, severe depression was more common in those with a history of depression.
B’ mod partikulari, depressjoni qawwija iktar komuni fost dawk li għandhom storja medika ta ’ depressjoni.
There have also been post-marketing reports of severe depression, death by suicide, delusions and psychosis-like behaviour.
Kien hemm ukoll rapporti wara li prodott beda jinbiegħ ta ’ depressjoni qawwija, mewt b’ suwiċidju, delużjonijiet u mġieba li tixbah dik psikotika.
Patients should be advised that if they experience symptoms such as severe depression, psychosis or suicidal ideation, they should contact their doctor immediately to assess the possibility that the symptoms may be related to the use of efavirenz, and if so, to determine whether the risks of continued therapy outweigh the benefits (see section 4.8).
Il- pazjenti għandhom jiġu mgħarrfa li jekk ikollhom sintomi bħal depressjoni qawwija, psikożi jew ħsibijiet dwar is- suwiċidju, għandhom jikkuntattjaw mal- ewwel lit- tabib tagħhom biex titqies il- possibilta` li dawn is- sintomi huma marbuta ma ’ l- użu ta ’ efavirenz, u jekk iva, biex jiġi determinat jekk ir- riskju li titkompla t- terapija jegħlbux il- benefiċċji (ara sezzjoni 4. 8).
Nervous system symptoms: symptoms including, but not limited to, dizziness, insomnia, somnolence, impaired concentration and abnormal dreaming are frequently reported undesirable effects in patients receiving efavirenz 600 mg daily in clinical studies (see section 4.8).
F’ pazjenti li kienu qed jieħdu 600 mg ta ’ efavirenz kuljum fi studji kliniċi ġew irrapurati b’ mod frekwenti sintomi li jinkludu, imma mhux limitati għal, sturdament, nuqqas ta ’ rqad, ngħas, diffikulta` ta ’ konċentrazzjoni u ħolm mhux normali.
Nervous system symptoms usually begin during the first one or two days of therapy and generally resolve after the first 2 - 4 weeks.
Is- sintomi fis- sistema nervuża s - soltu jibdew waqt l- ewwel jum jew jumejn tal- kura u ġeneralment jgħaddu wara l- ewwel ġimgħatejn sa 4 ġimgħat.
Patients should be informed that if they do occur, these common symptoms are likely to improve with continued therapy and are not predictive of subsequent onset of any of the less frequent psychiatric symptoms.
Il- pazjenti għandhom ikunu nfurmati li jekk iseħħu, dawn is- sintomi komuni aktarx li jitjiebu bil- kura u ma jfissrux li hemm iktar ċans li jitfaċċaw is- sintomi psikjatriċi inqas komuni.
Seizures: convulsions have been observed in patients receiving efavirenz, generally in the presence of known medical history of seizures.
Ġew osservati konvulżjonijiet f’ pazjenti li kienu qed jieħdu efavirenz, ġeneralment meta diġà kien hemm storja medika ta ’ aċċessjonijiet.
Patients who are receiving concomitant anticonvulsant medicinal products primarily metabolised by the liver, such as phenytoin, carbamazepine and phenobarbital, may require periodic monitoring of plasma levels.
Fi studju dwar
In a drug interaction study, carbamazepine plasma concentrations were decreased when carbamazepine was co-administered with efavirenz (see section 4.5).
4 l- interazzjoni tad- drogi, il- konċentrazzjonijiet ta ’ carbamazepine fil- plażma tnaqqsu meta carbamazepine ingħata flimkien ma ’ efavirenz (ara sezzjoni 4. 5).
Caution must be taken in any patient with a history of seizures.
Trid issir attenzjoni ma ’ kull pazjent li jkollu storja ta ’ aċċessjonijiet.
4 Effect of food: the administration of STOCRIN with food may increase efavirenz exposure (see section 5.2) and may lead to an increase in the frequency of adverse reactions (see section 4.8).
Effett ta ’ l- ikel: l- għoti ta ’ STOCRIN ma ’ l- ikel jista ’ jkabbar l- esponiment għal efavirenz (ara sezzjoni 5. 2) u jista ’ jwassal għal żieda fil- frekwenza tar- reazzjonijiet avversi (ara sezzjoni 4. 8).
It is recommended that STOCRIN be taken on an empty stomach, preferably at bedtime.
Huwa rakkomandat li STOCRIN jittieħed fuq stonku vojt, preferibbilment qabel l- irqad.
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.
Sindromu tar- Rijattivazzjoni Immunitarja: f’ pazjenti infettati bl- HIV b’ defiċjenza immunitarja qawwija meta jibdew jieħdu terapija kombinata antiretrovirali (CART), jista ’ jkun hemm reazzjoni infjammatorja għal patoġeni asintomatiċi jew residwi opportunistiċi u tista ’ tikkawża kondizzjonijiet kliniċi serji, jew sintomi li jiħraxu.
Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Tipikament, reazzjonijiet bħal dawn ġew osservati fl- ewwel ftit ġimgħat jew xhur mill- bidu tal- CART.
Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterial infections, and pneumonia caused by Pneumocystis jiroveci (formerly known as Pneumocystis carinii).
Eżempji relevanti huma retinite tas- sitomegalovirus, infezzjonijiet mikobatteriċi ġenerallizzati u/ jew fokali, u pulmonite kkawżata minn Pneumocystis jiroveci (li qabel kien magħruf bħala Pneumocystis carinii).
Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Kull sintomu ta ’ infjammazzjoni għandu jiġi evalwat u jekk hemm bżonn tibda l- kura.
Lipodystrophy and metabolic abnormalities: combination antiretroviral therapy has been associated with the redistribution of body fat (lipodystrophy) in HIV patients.
Lipodistrofija u anormalitajiet metaboliċi: it- terapija antiretrovirali kombinata ġiet assoċjata mar - ridistribuzzjoni tax- xaħam tal- ġisem (lipodistrofija) f’ pazjenti b’ HIV.
The long-term consequences of these events are currently unknown.
Bħalissa l- konsekwenzi fit- tul ta ’ dawn l- avvenimenti mhumiex magħrufin.
Knowledge about the mechanism is incomplete.
M’ hemmx għarfien sħiħ ta ’ dan il- mekkaniżmu.
A connection between visceral lipomatosis and PIs and lipoatrophy and NRTIs has been hypothesised.
Ġiet ipotiżżata konnessjoni bejn lipomatożi vixxerali u PIs u lipoatrofija u 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.
Ġie assoċjat riskju ikbar ta ’ lipodistrofija ma ’ fatturi individwali bħal m’ huma età ikbar, u ma ’ fatturi marbutin mad- drogi bħalm’ huma kura antiretrovirali iktar fit- tul u disturbi metaboliċi assoċjati magħha.
Clinical examination should include evaluation for physical signs of fat redistribution.
L- eżami kliniku għandu jinkludi l- evalwazzjoni ta ’ sinjali fiżiċi ta ’ ridistribuzzjoni tax- xaħam.
Consideration should be given to the measurement of fasting serum lipids and blood glucose.
Għandha tingħata konsiderazzjoni għall- kejl tal- lipidi tas- serum u tal- glucose fid- demm waqt sawm.
Lipid disorders should be managed as clinically appropriate (see section 4.8)..
Disturbi tal- lipidi għandhom jiġu kkurati kif jixraq klinikament (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 combination antiretroviral therapy (CART).
Ostjonekrożi: għalkemm l- etjoloġija titqies li għandha għadd ta ’ fatturi (inklużi użu ta ’ kortikosterojdi, konsum ta ’ l- alkoħol, immunosoppressjoni qawwija, indiċi ogħla tal- massa tal- ġisem), ġew irrappurtati każijiet ta ’ ostjonekrożi speċjalment f’ pazjenti b’ mard avvanzat ta ’ l- HIV u/ jew espożizzjoni fit- tul għat- terapija antiretrovirali kombinata (CART).
Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Lill- pazjenti għandu jintqal li għandhom ifittxu parir mediku jekk iħossu wġiegħ jew ebusija fil- ġogi, jew diffikultà fiċ- ċaqlieq.
Special populations:
Popolazzjonijet speċjali:
Liver disease: because of the extensive cytochrome P450-mediated metabolism of efavirenz and limited clinical experience in patients with chronic liver disease, caution must be exercised in administering efavirenz to patients with mild-to-moderate liver disease.
Mard fil- fwied: minħabba l- metaboliżmu ta ’ efavirenz li hu medjat estensivament minn cytochrome P450, u minħabba l- esperjenza klinika limitata f’ pazjenti b’ mard kroniku fil- fwied, trid issir attenzjoni meta jingħata efavirenz lil pazjenti li għandhom mard tal- fwied minn ħafif sa moderat.
Patients should be monitored carefully for dose-related adverse reactions, especially nervous system symptoms.
Il- pazjenti għandhom jiġu mmonitorjati sew għal reazzjonijiet avversi marbuta mal- mediċina, speċjalment għal sintomi tas- sistema nervuża.
Laboratory tests should be performed to evaluate their liver disease at periodic intervals (see section 4.2).
(ara sezzjoni 4. 2).
The safety and efficacy of efavirenz has not been established in patients with significant underlying liver disorders.
Is- sigurtà u l- effikaċja ta ’ efavirenz ma ġewx stabbiliti f’ pazjenti b’ mard ieħor sinifikanti fil- fwied.
Efavirenz is contraindicated in patients with severe hepatic impairment (see section 4.3).
Efavirenz m’ għandux jingħata lil pazjenti b’ indeboliment sever tal- fwied (ara sezzjoni 4. 3).
Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at increased risk for severe and potentially fatal hepatic adverse reactions.
Pazjenti b’ epatite kronika B jew C u kkurati b’ terapija antiretrovirali kombinata għandhom riskju ikbar ta ’ reazzjonijiet avversi severi jew potenzjalment fatali tal- fwied.
Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Pazjenti li l- fwied tagħhom ma kienx jaħdem tajjeb minn qabel inkluż b’ epatite attiva kronika għandhom frekwenza ikbar ta ’ anormalitajiet fil- funzjoni tal- fwied waqt it- terapija antiretrovirali kombinata u għandhom jiġi mmonitorjati skond il - prattika normali.
If there is evidence of worsening liver disease or persistent elevations of serum transaminases to greater than 5 times the upper limit of the normal range, the benefit of continued therapy with efavirenz needs to be weighed against the potential risks of significant liver toxicity.
Jekk hemm xhieda ta ’ mard tal- fwied li jeħżien jew ta ’ livelli persistentement għolja ta ’ serum transaminases għal iktar minn 5 darbiet il- livell ta ’ fuq tal- medda normali, il- benefiċċju tat - tkomplija tat- terapija b’ efavirenz għandu jitkejjel kontra r- riskji potenzjali ta ’ tossiċita` sinifikanti tal - fwied.
In such patients, interruption or discontinuation of treatment must be considered (see section 4.8).
F’ pazjenti bħal dawn, għandha titqies l- interruzzjoni jew il- waqfien tal- kura (ara sezzjoni 4. 8).
In patients treated with other medicinal products associated with liver toxicity, monitoring of liver enzymes is also recommended.
F’ pazjenti kkurati bi prodotti mediċinali oħra marbuta ma ’ tossiċita` fil- fwied, huwa rakkomandat li jkun hemm monitoraġġ ta ’ l- enzimi tal- fwied.
In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
F’ każ ta ’ terapija antiretrovirali li qed tingħata fl- istess ħin għall- epatite B u C, jekk jogħġbok irreferi wkoll għall- informazzjoni relevanti dwar il- prodott għal dawn il- prodotti mediċinali.
Renal insufficiency: the pharmacokinetics of efavirenz have not been studied in patients with renal insufficiency; however, less than 1% of an efavirenz dose is excreted unchanged in the urine, so the impact of renal impairment on efavirenz elimination should be minimal (see section 4.2).
5 Indeboliment renali: il- karatteristiċi farmakokinetiċi ta ’ efavirenz ma ġewx studjati f’ pazjenti b’ Insuffiċjenza fil- kliewi; madankollu, inqas minn 1% tad- doża ta ’ efavirenz titneħħa fl- urina bla ma tinbidel, għalhekk l- impatt ta ’ l- indeboliment tal- kliewi fuq it- tneħħija ta ’ efavirenz huwa minimu (ara sezzjoni 4. 2).
There is no experience in patients with severe renal failure and close safety monitoring is recommended in this population.
M’ hemmx esperjenza f’ pazjenti b’ Insuffiċjenza severa fil- kliewi, u huwa rakkomandat li jkun hemm monitoraġġ attent dwar is- sigurta` f’ din il- popolazzjoni.
5 Elderly patients: insufficient numbers of elderly patients have been evaluated in clinical studies to determine whether they respond differently than younger patients.
Pazjenti anzjani: ma kienx hemm biżżejjed pazjenti anzjani li ġew evalwati fi studji kliniċi biex jiġi determinat jekk jirrispondux b’ mod differenti minn pazjenti iżgħar.
Paediatric patients: efavirenz has not been evaluated in children below 3 years of age or who weigh less than 13 kg.
Pazjenti pedjatriċi: efavirenz ma ġiex evalwat fi tfal taħt it- 3 snin jew li jiżnu inqas minn 13 kg..
Therefore, efavirenz should not be given to children less than 3 years of age.
Għalhekk, efavirenz m’ għandux jingħata lil tfal ta ’ inqas minn 3 snin.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Pazjenti bi problemi ereditarji rari ta ’ intolleranza ta ’ galactose, defiċjenza ta ’ Lapp lactase jew assorbiment ħażin ta ’ glucose- galactose m’ għandhomx jieħdu dan il- prodott mediċinali.
Individuals with these conditions may take efavirenz oral solution, which is free from lactose.
Individwi li għandhom dawn il- kondizzjonijiet jistgħu jieħdu efavirenz f’ soluzzjoni orali, li ma fihiex lactose.
Efavirenz is an inducer of CYP3A4 and an inhibitor of some CYP450 isoenzymes including CYP3A4 (see section 5.2).
Efavirenz jinduċi CYP3A4 u huwa impeditur ta ’ xi isoenzimi CYP450 fosthom CYP3A4 (ara sezzjoni 5. 2).
Other compounds that are substrates of CYP3A4 may have decreased plasma concentrations when co-administered with efavirenz.
Komposti oħra li huma substrati ta ’ CYP3A4 jista ’ jkollhom konċentrazzjonijiet imnaqqsa tal - plażma meta jingħataw flimkien ma ’ efavirenz.
Efavirenz exposure may also be altered when given with medicinal products or food (for example, grapefruit juice) which affect CYP3A4 activity.
L- esponiment għal efavirenz tista ’ wkoll tinbidel meta jingħata ma ’ prodotti mediċinali jew ikel (ngħidu aħna, meraq tal- grejpfrut) li jista ’ jaffettwa l- attivita` ta ’ CYP3A4.
Contraindications of concomitant use Efavirenz must not be administered concurrently with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, or ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) since inhibition of their metabolism may lead to serious, life-threatening events (see section 4.3).
Kontra- indikazzjonijiet ta ’ l- użu simultanju Efavirenz m’ għandux jingħata flimkien ma ’ terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, jew ergot alkaloids (ngħidu aħna, ergotamine, dihydroergotamine, ergonovine, u methylergonovine) billi l- inibizzjoni tal- metaboliżmu tagħhom jista ’ jwassal għal avvenimenti serji u ta ’ riskju għall- ħajja (ara sezzjoni 4. 3).
John’ s wort (Hypericum perforatum): co-administration of efavirenz and St.
John’ s wort (Hypericum perforatum): l- għoti fl- istess ħin ta ’ efavirenz mas- St.
John’ s wort or herbal preparations containing St.
John’ s wort jew ma ’ preparazzjonijiet tal- ħxejjex li fihom is- St.
John’ s wort is contraindicated.
John’ s wort huwa kontra- indikat.
Plasma levels of efavirenz can be reduced by concomitant use of St.
Il- livelli tal- plasma ta ’ efavirenz jistgħu jitnaqqsu permezz ta ’ użu konkomittanti ta ’ St.
John's wort due to induction of drug metabolising enzymes and/ or transport proteins by St.
John' s wort minħabba l- induzzjoni ta ’ enzimi li jimmetabolizzaw il- mediċini u/ jew jittrasportaw il- proteini permezz ta ’ St.
John's wort.
John' s wort.
If a patient is already taking St.
Jekk pazjent ikun diġà qed jieħu St.
John’ s wort, check viral levels and if possible efavirenz levels.
John’ s wort, iċċekkja l- livelli virali u jekk possibbli l- livelli ta ’ efavirenz.
Efavirenz levels may increase on stopping St.
Il- livelli ta ’ efavirenz jistgħu jiżdiedu malli jitwaqqaf St.
John’ s wort and the dose of efavirenz may need adjusting.
John’ s wort u d- doża ta ’ efavirenz jista ’ jkollha bżonn ta ’ aġġustament.
The inducing effect of St.
L- effetti ta ’ induzzjoni ta ’ St.
John’ s wort may persist for at least 2 weeks after cessation of treatment (see section 4.3).
John’ s wort jistgħu jibqgħu preżenti għal mill- inqas ġimagħtejn wara l- waqfien tat- trattament (ara sezzjoni 4. 3).
Other interactions Interactions between efavirenz and protease inhibitors, antiretroviral agents other than protease inhibitors and other non-antiretroviral medicinal products are listed in Table 2 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, and once every 8 or 12 hours as “ q8h” or “ q12h”).
Interazzjonijiet oħra L- interazzjonijiet bejn efavirenz u l- inibituri protease, sustanzi antiretrovirali li mhumiex inibituri protease u prodotti mediċinali oħra li mhumiex anti- retrovirali huma elenkati f’ Tabella 2 hawn isfel (żieda hija indikata bħala “ ↑ ”, tnaqqis bħala “ ↓ ”, ebda bidla bħala “ ↔ ”, u darba kull 8 jew 12- il siegħa bħala “ q8h ” jew “ q12h ”).
If available, 90% or 95% confidence intervals are shown in parentheses.
Jekk ikunu disponibbli, l- intervalli ta ’ kunfidenza ta ’ 90% jew 95% jiġu murija fil- parentesi.
Studies were conducted in healthy subjects unless otherwise noted.
L- istudji saru fuq individwi b’ saħħithom sakemm mhux innotat mod ieħor.
Interaction studies have only been performed in adults.
Studji ta ’ interazzjoni saru biss fuq adulti.
Interactions between efavirenz and other medicinal products
Interazzjonijiet bejn efavirenz u prodotti mediċinali oħra
Medicinal product by therapeutic
Prodott mediċinali skond l- oqsma terapewtiċi (doża) ANTI- INFETTIVI Antiretrovirali Inibituri protease (PI)
Mean percent change in AUC, Cmax, Cmin with confidence intervals if availablea (mechanism)
Effetti fuq il- livelli tal- mediċina Bidla perċentwali medja fl - AUC, Cmax, Cmin bl- intervalli ta ’ kunfidenza jekk disponibblia (mekkaniżmu)
co-administration with efavirenz
Rakkomandazzjoni rigward l - għoti fl- istess ħin ma ’ efavirenz
ANTI-INFECTIVES Antiretrovirals Protease inhibitors (PI) Atazanavir/ ritonavir/ Efavirenz (400 mg once daily/ 100 mg once daily/ 600 mg once daily, all administered with food)
Atazanavir/ ritonavir/ Efavirenz (400 mg darba kuljum/ 100 mg darba kuljum/ 600 mg darba kuljum, kollha mogħtija mal- ikel)
AUC: ↔ * (↓ 9% to ↑ 10%) Cmax: ↑ 17%* (↑ 8% to ↑ 27%) Cmin: ↓ 42%* (↓ 31% to ↓ 51%)
AUC: ↔ * (↓ 9% sa ↑ 10%) Cmax: ↑ 17% * (↑ 8% sa ↑ 27%) Cmin: ↓ 42% * (↓ 31% sa ↓ 51%)
Co-administration of efavirenz with atazanavir/ ritonavir is not recommended.
L- għoti fl- istess ħin ta ’ efavirenz ma ’ atazanavir/ ritonavir mhuwiex rakkomandat.
If the co-administration of atazanavir with an NNRTI is required, an
Jekk l- għoti fl- istess ħin ta ’ atazanavir ma ’ NNRTI ikun meħtieġ, żieda fid- doża kemm ta ’ atazanavir kif ukoll ta ’ ritonavir għal 400 mg u 200 mg, rispettivament, f’ kombinazzjoni ma ’ efavirenz tista ’ tiġi kkunsidrata b’ monitoraġġ kliniku mill- qrib.
Atazanavir/ ritonavir/ Efavirenz (400 mg once daily/ 200 mg once daily/ 600 mg once daily, all administered with food)
Atazanavir/ ritonavir/ Efavirenz (400 mg darba kuljum/ 200 mg darba kuljum/ 600 mg darba kuljum, kollha mogħtija mal- ikel)
AUC: ↔ */ ** (↓ 10% to ↑ 26%) Cmax: ↔ */ ** (↓ 5% to ↑ 26%) Cmin: ↑ 12%*/ ** (↓ 16% to ↑ 49%) (CYP3A4 induction). * When compared to atazanavir 300 mg/ ritonavir 100 mg once daily in the evening without efavirenz.
AUC: ↔ * / ** (↓ 10% sa ↑ 26%) Cmax: ↔ * / ** (↓ 5% sa ↑ 26%) Cmin: ↑ 12% * / ** (↓ 16% sa ↑ 49%) (CYP3A4 induction). * Meta mqabbla ma ’ atazanavir 300 mg/ ritonavir 100 mg darba kuljum filgħaxija mingħajr efavirenz.
This decrease in atazanavir Cmin might negatively impact the efficacy of atazanavir. ** based on historical comparison
Dan it- tnaqqis f’ atazanavir Cmin jista ’ jkollu impatt negattiv fuq l- effikaċja ta ’ atazanavir. ** abbażi ta ’ tqabbil storiku
increase in the dose of both atazanavir and ritonavir to 400 mg and 200 mg, respectively, in combination with efavirenz could be considered with close clinical monitoring.
żieda fid- doża kemm ta ’ atazanavir kif ukoll ta ’ ritonavir għal 400 mg u 200 mg, rispettivament, f’ kombinazzjoni ma ’ efavirenz tista ’ tiġi kkunsidrata b’ monitoraġġ kliniku mill- qrib
The clinical significance of the changes has not been established.
ma ġiex stabbilit.
Similar findings are expected with the approved
Tisjib simili
*lower than recommended dose
darbtejn kuljum/ 600 mg darba kuljum)
AUC: ↑ 21% Cmin: ↑ 17% (CYP3A4 inhibition)
Cmin: ↓ 31% (induzzjoni ta ’ CYP3A4) Efavirenz:
darunavir/ ritonavir 600/ 100 mg twice daily dose.
Din il -
This combination should be used with caution.
kombinazzjoni għandha tintuża b’ kawtela.
See ritonavir row below.
Ara r- ringiela ta ’ ritonavir taħt.
Fosamprenavir/ ritonavir/ Efavirenz (700 mg twice daily/ 100 mg twice daily/ 600 mg once daily)
(700 mg darbtejn kuljum/ 100 mg
No clinically significant pharmacokinetic interaction.
klinikament sinifikanti.
No dosage adjustment is necessary for any of these medicinal products.
mediċinali.
See also ritonavir row below.
Ara wkoll ir- ringiela dwar ritonavir hawn isfel.
Interaction not studied
L- interazzjoni ma ġietx studjata
No dosage adjustment is necessary for any of these medicinal products.
M’ hemm bżonn ta ’ ebda aġġustament fid- doża għal xi prodott mediċinali minn dawn.
Not recommended, as the exposure to both PIs is expected to be significantly decreased.
Mhux rakkomandat minħabba li l - espożizzjoni għaż- żewġ PIs hija mistennija li tkun ferm inqas.
Indinavir/ Efavirenz (800 mg q8h/ 200 mg once daily)
Indinavir/ Efavirenz (800 mg q8h/ 200 mg darba kuljum)
No clinically significant
AUC: ↓ 31% (↓ 8 għal ↓ 47) Cmin: ↓ 40% Tnaqqis simili fl- espożizzjonijiet għal indinavir ġew osservati meta indinavir 1. 000 mg q8h ingħata
While the clinical significance of decreased indinavir concentrations has not been established, the magnitude of the observed pharmacokinetic interaction should be taken into consideration when choosing a regimen containing both efavirenz and indinavir.
Filwaqt li ma ġiex stabbilit is - sinifikat kliniku ta ’ konċentrazzjonijiet imnaqqsa ta ’ indinavir, għandu jiġi kkunsidrat id- daqs ta ’ l- interazzjoni farmakokinetika osservata meta
percent change in AUC,
Indinavir/ Efavirenz (1, 000 mg q8h/ 600 mg darba kuljum)
co-administration with
flimkien ma ’ efavirenz 600 mg kuljum Efavirenz:
Cmax, Cmin with confidence intervals if availablea (mechanism)
Ebda interazzjoni farmakokinetika klinikament sinifikanti
efavirenz
M’ hemmx bżonn ta ’ aġġustament fid- doża għal efavirenz meta jingħata ma ’ indinavir jew indinavir/ ritonavir.
Indinavir/ ritonavir/ Efavirenz (800 mg twice daily/ 100 mg twice daily/ 600 mg once daily)
Indinavir/ Ritonavir/ Efavirenz (800 mg darbtejn kuljum/ 100 mg
AUC: ↓ 25% (↓ 16 to ↓ 32) b Cmax: ↓ 17% (↓ 6 to ↓ 26)b Cmin: ↓ 50% (↓ 40 to ↓ 59)b
AUC: ↓ 25% (↓ 16 għal ↓ 32) b
given with indinavir or indinavir/ ritonavir.
darbtejn kuljum/ 600 mg darba kuljum)
Efavirenz:
Cmax: ↓ 17% (↓ 6 għal ↓ 26) b Cmin: ↓ 50% (↓ 40 għal ↓ 59) b Efavirenz:
No clinically significant pharmacokinetic interaction The geometric mean Cmin for indinavir (0.33 mg/ l) when given with ritonavir and efavirenz was higher than the mean historical Cmin (0.15 mg/ l) when indinavir was given alone at 800 mg q8h.
Ebda interazzjoni farmakokinetika klinikament sinifikanti Il- Cmin ġeometrika medja għal indinavir (0. 33 mg/ l) meta ngħata ma ’ ritonavir u efavirenz kienet ogħla mill- Cmin storika medja (0. 15 mg/ l) meta indinavir ingħata waħdu f’ doża ta ’ 800 mg q8h.
In HIV-1 infected patients (n = 6), the pharmacokinetics of indinavir and efavirenz were generally comparable to these uninfected volunteer data.
F’ pazjenti infettati bl- HIV- 1 (n = 6), il- farmakokinetiċi ta ’ indinavir u efavirenz kienu ġeneralment komparabbli ma ’ din id- dejta dwar voluntiera mhux infettati.
See also ritonavir row below.
hawn isfel.
Lopinavir/ ritonavir soft capsules or oral solution/ Efavirenz
Pilloli rotob jew soluzzjoni orali ta ’ Lopinavir/ ritonavir/ efavirenz
Substantial decrease in lopinavir exposure.
tnaqqis sostanzjali fl- esponiment għal lopinavir.
With efavirenz, an increase of the lopinavir/ ritonavir soft capsule or oral solution doses by 33% should be considered
Ma ’ efavirenz, għandha tiġi kkunsidrata żieda ta ’ 33% fid- dożi ta ’ lopinavir/ ritonavir kapsula ratba jew soluzzjoni orali
Lopinavir/ ritonavir tablets/ Efavirenz
Pilloli ta ’ Lopinavir/ ritonavir/ efavirenz
Caution is warranted
(4 kapsuli/ ~6. 5 ml darbtejn kuljum minflok 3 kapsuli/ 5 ml darbtejn kuljum).
The dosage of
Hija meħtieġa kawtela billi dan l- aġġustament fid- doża jista ’ ma jkunx suffiċjenti f’ xi pazjenti.
(500/ 125 mg twice daily/ 600 mg once daily)
Id- dożaġġ ta ’ pilloli ta ’ lopinavir/ ritonavir għandu jiżdied għal 500/ 125 mg darbtejn kuljum meta mogħti flimkien ma ’ efavirenz 600 mg kuljum.
Nelfinavir/ Efavirenz (750 mg q8h/ 600 mg once daily)
Nelfinavir/ Efavirenz (750 mg q8h/ 600 mg darba kuljum)
AUC: ↑ 20% (↑ 8 to ↑ 34) Cmax: ↑ 21% (↑ 10 to ↑ 33) The combination was generally well tolerated.
AUC: ↑ 20% (↑ 8 għal ↑ 34) Cmax: ↑ 21% (↑ 10 għal ↑ 33) It- taħlita ġeneralment kienet ittollerata sewwa.
No dosage adjustment is necessary for either medicinal product.
M’ hemm bżonn ta ’ aġġustament fid- doża għall- ebda wieħed minn dawn il- prodotti mediċinali.
8 Medicinal product by therapeutic
8 Prodott mediċinali skond l- oqsma terapewtiċi (doża)
Cmax, Cmin with confidence intervals if availablea (mechanism)
Effetti fuq il- livelli tal- mediċina Bidla perċentwali medja fl - AUC, Cmax, Cmin bl- intervalli ta ’ kunfidenza jekk disponibblia (mekkaniżmu)
efavirenz
Rakkomandazzjoni rigward l - għoti fl- istess ħin ma ’ efavirenz
Ritonavir/ Efavirenz (500 mg twice daily/ 600 mg once daily)
Ritonavir/ Efavirenz (500 mg darbtejn kuljum/ 600 mg darba kuljum)
Morning AUC: ↑ 18% (↑ 6 to ↑ 33) Evening AUC: ↔ Morning Cmax: ↑ 24% (↑ 12 to ↑ 38) Evening Cmax: ↔ Morning Cmin: ↑ 42% (↑ 9 to ↑ 86)b Evening Cmin: ↑ 24% (↑ 3 to ↑ 50)b Efavirenz:
AUC filgħodu: ↑ 18% (↑ 6 għal ↑ 33) AUC filgħaxija: ↔ Cmax filgħodu: ↑ 24% (↑ 12 għal ↑ 38) Cmax filgħaxija: ↔ Cmin filgħodu: ↑ 42% (↑ 9 għal ↑ 86) b Cmin filgħaxija ↑ 24% (↑ 3 għal ↑ 50) b Efavirenz:
AUC: ↑ 21% (↑ 10 to ↑ 34) Cmax: ↑ 14% (↑ 4 to ↑ 26) Cmin: ↑ 25% (↑ 7 to ↑ 46)b (inhibition of CYP-mediated oxidative metabolism) When efavirenz was given with ritonavir 500 mg or 600 mg twice daily, the combination was not well tolerated (for example, dizziness, nausea, paraesthesia and elevated liver enzymes occurred).
AUC: ↑ 21% (↑ 10 għal ↑ 34) Cmax: ↑ 14% (↑ 4 għal ↑ 26) Cmin: ↑ 25% (↑ 7 għal ↑ 46) b (inibizzjoni ta ’ metaboliżmu ossidattiv medjat minn CYP) Meta efavirenz ingħata ma ’ ritonavir 500 mg jew 600 mg darbtejn kuljum, it- taħlita ma kinetx ittollerata sewwa (per eżempju, kien hemm sturdament, dardir, parasteżija u żieda fl - enzimi tal- fwied).
Sufficient data on the tolerability of efavirenz with low-dose ritonavir (100 mg, once or twice daily) are not available.
M’ hemmx biżżejjed informazzjoni dwar it - tollerabilità ta ’ efavirenz ma ’ doża baxxa ta ’ ritonavir (100 mg, darba jew darbtejn kuljum).
When using efavirenz with low-dose ritonavir, the possibility of an increase in the incidence of efavirenz-associated adverse events should be considered, due to possible pharmacodynamic interaction.
Meta efavirenz jintuża ma ’ ritonavir, wieħed għandu jikkunsidra l- possibilità ta ’ żieda fl - inċidenza ta ’ episodji avversi assoċjati ma ’ efavirenz, minħabba interazzjoni farmakodinamika possibbli.
Saquinavir/ ritonavir/ Efavirenz CCR5 antagonist
Saquinavir/ Ritonavir/ Efavirenz Antagonista CCR5
Interaction not studied.
Ma ġietx studjata l- interazzjoni.
No data are available to make a dose recommendation.
M’ hemmx informazzjoni disponibbli biex issir rakkomandazzjoni dwar doża.
See also ritonavir row above.
Ara wkoll ir- ringiela dwar ritonavir hawn fuq.
Use of efavirenz in combination with saquinavir as the sole protease inhibitor is not recommended.
L- użu ta ’ efavirenz f’ kombinazzjoni ma ’ saquinavir bħala l- uniku inibitur tal- protease mhuwiex rakkomandat.
Maraviroc/ Efavirenz (100 mg twice daily/ 600 mg once daily) Integrase strand transfer inhibitor
Maraviroc/ Efavirenz (100 mg darbtejn kuljum/ 600 mg darba kuljum)
AUC12: ↓ 45% (↓ 38 to ↓ 51) Cmax: ↓ 51% (↓ 37 to ↓ 62) Efavirenz concentrations not measured, no effect is expected.
AUC12: ↓ 45% (↓ 38 sa ↓ 51) Cmax: ↓ 51% (↓ 37 sa ↓ 62) Konċentrazzjonijiet ta ’ Efavirenz mhux imkejla, ebda effett ma huwa mistenni.
Refer to the Summary of Product Characteristics for the medicinal product containing maraviroc.
Irreferi għas- Sommarju tal - Karatteristiċi tal- Prodott għall - prodott mediċinali li fih maraviroc.
Raltegravir/ Efavirenz (400 mg single dose/ -) NRTIs and NNRTIs
Inibitur ta ’ trasferiment ta ’ faxxa ta ’ integrase Raltegravir/ Efavirenz (400 mg doża waħda / -)
AUC: ↓ 36% C12: ↓ 21% Cmax: ↓ 36% (UGT1A1 induction)
AUC: ↓ 36% C12: ↓ 21% Cmax: ↓ 36% (Induzzjoni ta ’ UGT1A1)
No dosage adjustment is necessary for raltegravir.
Ma hemm bżonn ta ’ ebda aġġustament tad- dożaġġ għal raltegravir.