qanastek/EMEA-V3 huggingface dataset:
Phenytoin, Phenobarbital, and other anticonvulsants that are substrates of CYP450 isoenzymes
14 Phenytoin, Phenobarbital, u antikonvulsivi oħra li huma sottostrati ta ’ isoenzimi CYP450
Interaction not studied with efavirenz, emtricitabine, or tenofovir disoproxil fumarate.
L- interazzjoni ma ġietx studjata b’ efavirenz, emtricitabine, jew tenofovir disoproxil fumarate.
There is a potential for reduction or increase in the plasma concentrations of phenytoin, phenobarbital and other anticonvulsants that are substrates of CYP450 isoenzymes with efavirenz.
Hemm potenzjal għal tnaqqis fil- konċentrazzjonijiet tal- plażma ta ’ phenytoin, phenobarbital u antikonvulsivi oħra li huma sottostrati ta ’ isoenzimi ta ’ CYP450 b’ efavirenz.
When Atripla is co- administered with an anticonvulsant that is a substrate of CYP450 isoenzymes, periodic monitoring of anticonvulsant levels should be conducted.
Meta Atripla tingħata fl - istess ħin ma ’ antikonvulsiv li jkun sottostrat ta ’ isoenzimi CYP450, għandu jsir monitoraġġ perjodiku tal - livelli ta ’ l- antikonvulsiv.
Clinically significant interactions are not expected since vigabatrin and gabapentin are exclusively eliminated unchanged in the urine and are unlikely to compete for the same metabolic enzymes and elimination pathways as efavirenz.
Mhumiex mistennija interazzjonijiet kliniċi sinifikanti billi vigabatrin u gabapentin huma esklussivament eliminati mhux mibdula fl- awrina u mhumiex probabbli li jikkompetu għall- istess enzimi metaboliċi u mogħdijiet ta ’ tneħħija bħal efavirenz.
Atripla and vigabatrin or gabapentin can be co- administered without dose adjustment.
Atripla u vigabatrin jew gabapentin jistgħu jingħataw fl- istess ħin mingħajr aġġustament fid - doża.
Vigabatrin/ Tenofovir disoproxil fumarate Gabapentin/ Tenofovir disoproxil fumarate
Vigabatrin/ Tenofovir disoproxil fumarate Gabapentin/ Tenofovir disoproxil fumarate ANTIDEPRESSIVI
14 ANTIDEPRESSANTS Selective Serotonin Reuptake Inhibitors (SSRIs) Sertraline/ Efavirenz (50 q. d. / 600 q. d.)
Inibituri Selettivi ta ’ l- Assorbiment mill- ġdid ta ’ Serotonin (SSRIs) Sertraline/ Efavirenz (50 q. d. / 600 q. d.)
AUC: ↔ Cmax: ↑ 11% (↑ 6 to ↑ 16) Cmin: ↔ (CYP3A4 induction)
AUC: ↔ Cmax: ↑ 11% (↑ 6 għal ↑ 16) Cmin: ↔ (Induzzjoni ta ’ CYP3A4)
When co-administered with Atripla, sertraline dose increases should be guided by clinical response.
doża ta ’ sertraline għandhom ikunu ggwidati mir- rispons kliniku.
AUC: ↔ Cmax: ↔ Cmin: ↔ Efavirenz:
Cmax: ↔ Cmin: ↔ Efavirenz:
Atripla and paroxetine can be co-administered without dose adjustment.
mingħajr aġġustament fid - doża.
Since fluoxetine shares a similar metabolic profile with paroxetine, i. e. a strong CYP2D6 inhibitory effect, a similar lack of interaction would be expected for fluoxetine.
Billi fluoxetine jaqsam profil metaboliku simili ma ’ paroxetine, jiġifieri effett inibitorju qawwi ta ’ CYP2D6, huwa mistenni nuqqas simili ta ’ interazzjoni għal fluoxetine.
Atripla and fluoxetine can be co-administered without dose adjustment.
Atripla u fluoxetine jistgħu jingħataw fl- istess ħin mingħajr aġġustament fid - doża.
Fluoxetine/ Emtricitabine Fluoxetine/ Tenofovir disoproxil fumarate CARDIOVASCULAR AGENTS Calcium Channel Blockers
Fluoxetine/ Emtricitabine Fluoxetine/ Tenofovir disoproxil fumarate
Diltiazem/ Efavirenz (240 q. d. / 600 q. d.)
15 SUSTANZI KARDJOVASKULARI Imblokkaturi tal- Kanali tal- Kalċju Diltiazem/ Efavirenz (240 q. d. / 600 q. d.)
AUC: ↓ 69% (↓ 55 to ↓ 79) Cmax: ↓ 60% (↓ 50 to ↓ 68) Cmin: ↓ 63% (↓ 44 to ↓ 75) Desacetyl diltiazem:
Cmax: ↓ 60% (↓ 50 għal ↓ 68) Cmin: ↓ 63% (↓ 44 għal ↓ 75) Desacetyl diltiazem:
AUC: ↑ 11% (↑ 5 to ↑ 18) Cmax: ↑ 16% (↑ 6 to ↑ 26) Cmin: ↑ 13% (↑ 1 to ↑ 26) (CYP3A4 induction) The increase in efavirenz pharmacokinetic parameters is not considered clinically significant.
AUC: ↑ 11% (↑ 5 għal ↑ 18) Cmax: ↑ 16% (↑ 6 għal ↑ 26) Cmin: ↑ 13% (↑ 1 għal ↑ 26) (Induzzjoni ta ’ CYP3A4) Iż- żieda fil- parametri farmakokinetiċi ta ’ efavirenz mhix meqjusa klinikament sinifikanti.
Dose adjustments of diltiazem when co- administered with Atripla should be guided by clinical response (refer to the Summary of Product Characteristics for diltiazem).
fl- istess ħin ma ’ Atripla għandhom ikunu ggwidati mir- rispons kliniku (irreferi għas- Sommarju tal - Karatteristiċi tal- Prodott għal diltiazem).
Diltiazem/ Emtricitabine Diltiazem/ Tenofovir disoproxil fumarate
Diltiazem/ Emtricitabine Diltiazem/ Tenofovir disoproxil fumarate
15 Verapamil, Felodipine, Nifedipine
Verapamil, Felodipine, Nifedipine u Nicardipine
emtricitabine, or tenofovir disoproxil fumarate.
L- interazzjoni ma ġietx studjata b’ efavirenz, emtricitabine, jew tenofovir disoproxil fumarate.
When efavirenz is co- administered with a calcium channel blocker that is a substrate of the CYP3A4 enzyme, there is a potential for reduction in the plasma concentrations of the calcium channel blocker.
Meta efavirenz jingħata fl- istess ħin ma ’ imblokkatur tal - kanali tal- kalċju li jkun sottostrat ta ’ enzima CYP3A4, hemm potenzjal għal tnaqqis fil- konċentrazzjonijiet tal- plażma ta ’ l- imblokkatur tal- kanali tal- kalċju.
calcium channel blockers when co-administered with Atripla should be guided by clinical response (refer to the Summary of Product Characteristics for the calcium channel blocker).
L- aġġustamenti fid- doża ta ’ l- imblokkaturi tal - kanali tal- kalċju meta jingħataw fl- istess ħin ma ’ Atripla għandhom ikunu ggwidati mir- rispons kliniku (irreferi għas - Sommarju tal- Karatteristiċi tal- Prodott għall - imblokkatur tal- kanali tal - kalċju).
LIPID LOWERING MEDICINAL PRODUCTS HMG Co-A Reductase Inhibitors Atorvastatin/ Efavirenz (10 q. d. / 600 q. d.)
PRODOTTI MEDIĊINALI LI JBAXXU L- LIPIDI Inibituri HMG Co- A Reductase Atorvastatin/ Efavirenz (10 q. d. / 600 q. d.)
AUC: ↓ 43% (↓ 34 to ↓ 50) Cmax: ↓ 12% (↓ 1 to ↓ 26) 2-hydroxy atorvastatin:
AUC: ↓ 43% (↓ 34 għal ↓ 50)
AUC: ↓ 34% (↓ 21 to ↓ 41) Cmax: ↓ 20% (↓ 2 to ↓ 26)
AUC: ↓ 34% (↓ 21 għal ↓ 41) Cmax: ↓ 20% (↓ 2 għal ↓ 26) L- interazzjoni ma ġietx studjata.
Cholesterol levels should be periodically monitored when atorvastatin, pravastatin, or simvastatin is co-administered with Atripla.
mmonitorjati perjodikament meta atorvastatin, pravastatin, jew simvastatin jingħataw fl- istess ħin ma ’ Atripla.
Dosage adjustments of statins may be required (refer to the Summary of Product Characteristics for the statin).
Jistgħu jkunu meħtieġa aġġustamenti fid- doża tas - statins (irreferi għas - Sommarju tal- Karatteristiċi tal- Prodott għall- istatin).
Pravastatin/ Emtricitabine Pravastatin/ Tenofovir disoproxil fumarate
Pravastatin/ Emtricitabine Pravastatin/ Tenofovir disoproxil fumarate
Simvastatin/ Efavirenz (40 q. d. / 600 q. d.)
16 Simvastatin/ Efavirenz (40 q. d. / 600 q. d.)
AUC: ↓ 69% (↓ 62 to ↓ 73) Cmax: ↓ 76% (↓ 63 to ↓ 79) Simvastatin acid:
AUC: ↓ 69% (↓ 62 għal ↓ 73) Cmax: ↓ 76% (↓ 63 għal ↓ 79) Aċidu Simvastatin:
AUC: ↓ 58% (↓ 39 to ↓ 68) Cmax: ↓ 51% (↓ 32 to ↓ 58) Total active HMG Co-A reductase inhibitors:
AUC: ↓ 58% (↓ 39 għal ↓ 68) Cmax: ↓ 51% (↓ 32 għal ↓ 58) Inibituri attivi totali HMG Co- A reductase:
AUC: ↓ 60% (↓ 52 to ↓ 68) Cmax: ↓ 62% (↓ 55 to ↓ 78) Total HMG Co-A reductase inhibitors:
AUC: ↓ 60% (↓ 52 għal ↓ 68) Cmax: ↓ 62% (↓ 55 għal ↓ 78) Inibituri totali HMG Co- A reductase:
AUC: ↓ 60% (↓ 54 to ↓ 74) Cmax: ↓ 70% (↓ 58 to ↓ 85) (CYP3A4 induction) Co-administration of efavirenz with atorvastatin, pravastatin, or simvastatin did not affect efavirenz AUC or Cmax values.
AUC: ↓ 60% (↓ 54 għal ↓ 74) Cmax: ↓ 70% (↓ 58 għal ↓ 85) (Induzzjoni ta ’ CYP3A4) L- għoti fl- istess ħin ta ’ efavirenz ma ’ atorvastatin, pravastatin, jew simvastatin ma affettwax il- valuri AUC jew Cmax ta ’ efavirenz.
Simvastatin/ Emtricitabine Simvastatin/ Tenofovir disoproxil fumarate HORMONAL CONTRACEPTIVES
Simvastatin/ Emtricitabine Simvastatin/ Tenofovir disoproxil fumarate KONTRAĊETTIVI ORMONALI
Ethinyloestradiol/ Efavirenz (50 µg single dose/ 400 q. d.)
Ethinyloestradiol/ Efavirenz (50 µg doża waħda/ 400 q. d.)
AUC: ↑ 37% (↑ 25 to ↑ 51) Cmax: ↔ Efavirenz:
AUC: ↑ 37% (↑ 25 għal ↑ 51)
AUC: ↔ Cmax: ↔ (mechanism unknown) The clinical significance of the effect on ethinyloestradiol AUC is not known.
AUC: ↔ Cmax: ↔ (il- mekkaniżmu mhux magħruf) Is- sinifikat kliniku ta ’ l- effett fuq l- AUC ta ’ ethinyloestradiol mhuwiex magħruf.
Because the potential interaction of efavirenz, a component of Atripla, with oral contraceptives has not been fully characterised, a reliable method of barrier contraception must be used in addition to oral contraceptives
komponent ta ’ Atripla, ma ’ kontraċettivi orali ma ġietx kkaratterizzata kompletament, għandu jintuża metodu affidabbli ta ’ kontraċezzjoni tat- tip barriera flimkien mal - kontraċettivi orali (ara
16
Ethinyloestradiol:
Ethinyloestradiol/ Tenofovir disoproxil fumarate (-/ 300 q. d.)
disoproxil fumarate (- / 300 q. d.)
(see section 4.6).
sezzjoni 4. 6).
Norgestimate/ Ethinyloestradiol/ Emtricitabine IMMUNOSUPPRESSANTS
Norgestimate/ Ethinyloestradiol / Emtricitabine IMMUNOSOPPRESSANTI
Interaction not studied. ↓ exposure of tacrolimus may be expected (CYP3A4 induction).
L- interazzjoni ma ġietx studjata. ↓ fl- esponiment ta ’ tacrolimus tista tkun mistennija (induzzjoni ta ’ CYP3A4).
Tacrolimus is not anticipated to impact exposure of efavirenz.
Tacrolimus mhux mistenni li jkollu impatt fuq l- esponiment ta ’ efavirenz.
Dose adjustments of tacrolimus may be required.
Aġġustamenti fid- doża ta ’ tacrolimus jistgħu jkunu meħtieġa.
Close monitoring of tacrolimus concentrations for at least
Hu rakkomandat li jsir monitoraġġ mill- qrib tal- konċentrazzjonijiet ta ’ tacrolimus għal mill- inqas
Tacrolimus/ Emtricitabine/ Tenofovir disoproxil fumarate (0.1 mg/ kg q. d. / 200 mg/ 300 mg q. d.)
Tacrolimus/ Emtricitabine/ Tenofovir
AUC: ↔ Cmax: ↔ C24: ↔ Emtricitabine:
ġimgħatejn meta tibda jew
AUC: ↔ Cmax: ↔ C24: ↔
AUC: ↔
two weeks (until stable concentrations are reached) is recommended when starting or stopping treatment with Atripla.
twaqqaf il- kura b’ Atripla.
OPIOIDS
Emtricitabine:
Methadone/ Efavirenz (35-100 q. d. / 600 q. d.)
17 OPIOIDS Methadone/ Efavirenz (35- 100 q. d. / 600 q. d.)
AUC: ↓ 52% (↓ 33 to ↓ 66) Cmax: ↓ 45% (↓ 25 to ↓ 59) (CYP3A4 induction) In a study of HIV infected intravenous drug users, co-administration of efavirenz with methadone resulted in decreased plasma levels of methadone and signs of opiate withdrawal.
Cmax: ↓ 45% (↓ 25 għal ↓ 59) (Induzzjoni ta ’ CYP3A4) Fi studju ta ’ utilizzaturi tal- mediċina mill - vina infettati bl- HIV, l- għoti fl- istess ħin ta ’ efavirenz mal- methadone rriżulta fi tnaqqis fil- livelli tal- methadone fil- plażma u sinjali ta ’ opiate withdrawal.
The methadone dose was increased by a mean of 22% to alleviate withdrawal symptoms.
Id- doża tal - methadone ġiet miżjuda b’ medja ta ’ 22% biex jittaffew is- sintomi tal- withdrawal.
Patients receiving methadone and Atripla concomitantly should be monitored for signs of withdrawal and their methadone dose increased as required to alleviate withdrawal symptoms.
Atripla fl- istess ħin għandhom jiġu mmonitorjati għal sinjali ta ’ withdrawal u d- doża tal- methadone tagħhom għandha tiġi miżjuda kif meħtieġ sabiex jittaffew is - sintomi tal- withdrawal.
Methadone/ Tenofovir disoproxil fumarate (40-110 q. d. / 300 q. d.)
Methadone/ Tenofovir disoproxil fumarate (40- 110 q. d. / 300 q. d.)
Methadone/ Emtricitabine HERBAL PRODUCTS
Methadone/ Emtricitabine PRODOTTI TAL- ĦXEJJEX
John’ s wort (Hypericum perforatum)/ Efavirenz
John’ s wort (Hypericum perforatum) / Efavirenz
Plasma levels of efavirenz can be reduced by concomitant use of St.
Il- livelli ta ’ efavirenz fil- plażma jistgħu jitnaqqsu bl- użu konkomitanti 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- mediċina u/ jew proteini ta ’ trasport minn St.
Co-administration of Atripla and St.
L- għoti fl- istess ħin ta ’ Atripla u St.
If a patient is already taking St.
Jekk pazjent ikun diġà qiegħed jieħu St.
John’ s wort, stop
John’ s wort, waqqaf St.
John’ s wort (Hypericum perforatum)/ Emtricitabine
John’ s wort (Hypericum perforatum) / Emtricitabine
John’ s wort, check viral levels and if possible
jekk ikun possibbli l- livelli ta ’ efavirenz.
17 St.
St.
John’ s wort (Hypericum perforatum)/ Tenofovir disoproxil fumarate
John’ s wort (Hypericum perforatum) / Tenofovir disoproxil fumarate
Efavirenz levels may increase on stopping St.
Il- livelli ta ’ Efavirenz jistgħu jiżdiedu malli twaqqaf St.
The inducing effect of St.
L - effett induttiv ta ’ St.
John’ s wort may persist for at least 2 weeks after cessation of treatment.
John’ s wort jista ’ jippersisti għal mill- anqas ġimagħtejn wara t- twaqqif tat - trattament.
Studies conducted with other medicinal products: there were no clinically significant pharmacokinetic interactions when efavirenz was administered with azithromycin, cetirizine, lorazepam, nelfinavir, zidovudine, aluminium/ magnesium hydroxide antacids, famotidine or fluconazole.
Studji mwettqa ma ’ prodotti mediċinali oħrajn: ma kien hemm ebda interazzjoni farmakokinetika klinikament sinifikanti meta efavirenz ingħata ma ’ azithromycin, cetirizine, lorazepam, nelfinavir, zidovudine, aluminium/ magnesium hydroxide antacids, famotidine jew fluconazole.
The potential for interactions with efavirenz and other imidazole antifungals, such as ketoconazole, has not been studied.
Il- potenzjal għal interazzjonijiet ma ’ efavirenz u antifungali imidazole oħrajn, bħal ketoconazole, ma ġiex studjat.
There were no clinically significant pharmacokinetic interactions when emtricitabine was administered with stavudine, zidovudine or famciclovir.
Ma kien hemm ebda interazzjoni farmakokinetika klinikament sinifikanti meta emtricitabine ngħata ma ’ stavudine, zidovudine jew famciclovir.
There were no clinically significant pharmacokinetic interactions when tenofovir disoproxil fumarate was co-administered with adefovir dipivoxil, emtricitabine, nelfinavir or ribavirin.
Ma kien hemm ebda interazzjoni farmakokinetika klinikament sinifikanti meta tenofovir disoproxil fumarate ingħata fl- istess ħin ma ’ adefovir dipivoxil, emtricitabine, nelfinavir jew ribavirin.
Atripla should not be used during pregnancy unless clearly necessary (there are no other appropriate treatment options).
Atripla m’ għandhiex tintuża waqt it- tqala jekk m’ hemmx bżonn ċar (ma hemmx għażliet ta ’ trattament adattati oħra).
Women of child bearing potential: pregnancy should be avoided in women receiving Atripla.
Nisa li jistgħu jinqabdu tqal: it- tqala għandha tiġi evitata f’ nisa li qed jirċievu Atripla.
Barrier contraception should always be used in combination with other methods of contraception (for example, oral or other hormonal contraceptives) while on therapy with Atripla.
Kontraċezzjoni barriera għandha dejjem tintuża ma ’ metodi oħra ta ’ kontraċezzjoni (per eżempju, kontraċettivi orali jew ormonali) waqt terapija b’ Atripla.
Because of the long half-life of efavirenz, use of adequate contraceptive measures for 12 weeks after discontinuation of Atripla is recommended.
18 użu ta ’ miżuri ta ’ kontraċezzjoni adegwati għal 12- il ġimgħa wara t- twaqqif ta ’ Atripla.
Women of childbearing potential should undergo pregnancy testing before initiation of Atripla.
Nisa li jista ’ jkollhom it- tfal għandu jsirilhom test tat- tqala qabel tinbeda Atripla.
Pregnancy: there are no adequate or well-controlled studies of Atripla or its components in pregnant women.
Tqala: m’ hemmx studji adegwati jew ikkontrollati sewwa ta ’ Atripla jew tal- komponenti tagħha f’ nisa tqal.
In post-marketing experience through an antiretroviral pregnancy registry, more than 200 pregnancies with first-trimester exposure to efavirenz as part of a combination antiretroviral regimen have been reported with no specific malformation pattern.
Fl- esperjenza ta ’ wara t- tqegħid fis- suq permezz ta ’ reġistru tat- tqala antiretrovirali, aktar minn 200 tqaliet b’ esponiment għal efavirenz fl- ewwel trimestru bħala parti minn reġim antiretrovirali kkumbinat ġew irrapportati bla ebda mudell speċifiku ta ’ malformazzjonijiet.
Retrospectively in this registry, a small number of cases of neural tube defects, including meningomyelocele, have been reported but causality has not been established.
F’ dan ir- reġistru, retrospettivament, numru żgħir ta ’ difetti tat- tubu newrali, inkluża meningomyelocele, ġew irrapportati imma l- kawżalità ma ġietx stabilita.
Studies of efavirenz in animals have shown reproductive toxicity including marked teratogenic effects (see section 5.3).
Studji dwar efavirenz f’ annimali wrew tossiċità riproduttiva nklużi effetti teratoġeniċi evidenti (ara sezzjoni 5. 3).
Lactation: studies in rats have demonstrated that efavirenz and tenofovir are excreted in milk; concentrations of efavirenz were much higher than those in maternal plasma.
Treddigħ: studji fil- firien urew li efavirenz u tenofovir jiġu merħija fil- ħalib; il- konċentrazzjonijet ta ’ efavirenz kienu ħafna ogħla minn dawk fil- plażma ta ’ l- omm.
It is not known whether efavirenz, emtricitabine or tenofovir are excreted in human milk.
Mhux magħruf jekk efavirenz, emtricitabine jew tenofovir jiġux merħija fil- ħalib tal- bniedem.
Because of the potential for both HIV transmission and the potential for serious undesirable effects in breast-feeding infants, mothers should be instructed not to breast-feed if they are receiving Atripla.
Minħabba l- potenzjal kemm għal trasmissjoni ta ’ l- HIV u l- potenzjal għal effetti mhux mixtieqa serji fi trabi li jkunu qed jitreddgħu, l - ommijiet għandhom jiġu avżati biex ma jreddgħux jekk ikunu qegħdin jirċievu Atripla.
However, dizziness has been reported during treatment with efavirenz, emtricitabine and tenofovir disoproxil fumarate.
Madankollu waqt trattament b’ efavirenz, emtricitabine u tenofovir disoproxil fumarate ġie irrapportat sturdament.
Efavirenz may also cause impaired concentration and/ or somnolence.
Efavirenz jista ’ jikkaġuna wkoll konċentrazzjoni mxekkla u/ jew somnolenza.
Patients should be instructed that if they experience these symptoms they should avoid potentially hazardous tasks such as driving and operating machinery.
Il- pazjenti għandhom jiġu avżati li jekk jesperjenzaw dawn is- sintomi huma għandhom jevitaw attivitajiet potenzjalment perikolużi bħal sewqan u tħaddim ta ’ magni.
Assessment of adverse reactions for the fixed combination Atripla is based on experience from: • a 48-week clinical study of Atripla (see Table 2) • a clinical study in which efavirenz, emtricitabine and tenofovir disoproxil fumarate were co- administered (see Table 3) • clinical study and post-marketing experience with the individual components of Atripla (see Table 4).
L- evalwazzjoni ta ’ reazzjonijiet avversi għall- kumbinazzjoni fissa ta ’ Atripla hi bbażata fuq l - esperjenza minn: • studju kliniku dwar Atripla li dam 48 ġimgħa (ara Tabella 2) • studju kliniku li fih efavirenz, emtricitabine u tenofovir disoproxil fumarate ngħataw flimkien (ara Tabella 3) • studju kliniku u l- esperjenza ta ’ wara t- tqegħid fis- suq bil- komponenti individwali ta ’ Atripla (ara Tabella 4).
In Tables 2, 3 and 4 undesirable effects are presented in order of decreasing seriousness within each frequency grouping.
F’ Tabelli 2, 3 u 4 l- effetti mhux mixtieqa huma ppreżentati skond is- serjetà tagħhom f’ kull sezzjoni ta ’ frekwenza.
Frequencies are defined as very common (≥ 1/ 10), common (≥ 1/ 100, < 1/ 10) or uncommon (≥ 1/ 1,000, < 1/ 100).
Il- frekwenzi huma definiti bħala komuni ħafna (≥ 1/ 10), komuni (≥ 1/ 100, < 1/ 10) jew mhux komuni (≥ 1/ 1, 000, < 1/ 100).
Adverse reactions from clinical study experience with Atripla In a 48-week open-label randomised clinical study in HIV infected patients with successful virological suppression on their current antiretroviral regimen, patients either changed to Atripla (n=203) or continued on their original antiretroviral treatment regimen (n=97).
Reazzjonijiet avversi mill- esperjenza minn studji kliniċi dwar Atripla Fi studju kliniku li dam 48 ġimgħa, tat- tip każwali bit- tikketta mikxufa li sar fuq pazjenti nfettati bl - HIV li kellhom soppressjoni viroloġika li rnexxiet permezz tar- reġim antiretrovirali kurrenti tagħhom, il- pazjenti jew qalbu għal Atripla (n=203) jew komplew bir- reġim ta ’ trattament antiretrovirali oriġinali tagħhom (n=97).
Treatment-emergent adverse reactions considered possibly or probably related to study drugs reported in patients who received Atripla in study AI266073 are listed by body system organ class and frequency in Table 2.
Ir- reazzjonijiet avversi li ħarġu mit- trattament ikkunsidrati bħala possibbilment jew probabbilment relatati mal- mediċini ta ’ l- istudju, irrappurtati f’ pazjenti li rċivew Atripla fi studju AI266073 huma elenkati skond il- klassi tal- organi tas- sistema tal- ġisem u l - frekwenza f’ Tabella 2.
All treatment-emergent adverse reactions considered possibly or probably related to Atripla reported in study AI266073 (over 48 weeks)
Ir- reazzjonijiet avversi kollha li ħarġu mit- trattament ikkunsidrati bħala possibbilment jew probabbilment relatati ma ’ Atripla rrappurtati fi studju AI266073 (fuq perijodu ta ’ 48 ġimgħa)
Atripla (n=203) Metabolism and nutrition disorders:
Atripla (n=203) Disturbi fil- metaboliżmu u n- nutrizzjoni:
anorexia fat redistribution, hypertriglyceridaemia, weight decreased, increased appetite
anoreksja distribuzzjoni mill- ġdid tax- xaħam, ipertrigliċeridemija, tnaqqis fil- piż, żieda fl- aptit
nightmare, depression, depressed mood, anxiety, insomnia, mood altered, abnormal dreams, sleep disorder
ħmar il- lejl, dipressjoni, burdata ta ’ dwejjaq, ansjetà, nuqqas ta ’ rqad, tibdil fil- burdata, ħolm anormali, problemi biex torqod
confusional state, disorientation, personality change, mood swings, libido decreased
stat ta ’ konfużjoni, diżorjentament, tibdil fil - personalità, tibdil fil- burdata, tnaqqis fil- libido
Very common Common Uncommon
Komuni ħafna Komuni Mhux Komuni
dizziness somnolence, headache incoherent speech
sturdament ngħas, uġigħ ta ’ ras diskors li ma jiftiehemx
vision blurred, altered visual depth perception
vista mċajpra, tibdil fil- perċezzjoni tal- profondità tal- vista
vertigo
sturdament
hot flush
fwawar
diarrhoea, nausea pancreatitis acute, vomiting, paraesthesia oral, hypoaesthesia oral, flatulence, dry mouth
dijarea, nawseja pankreatite akuta, rimettar, parasteżija orali, ipoestesija orali, gass, ħalq xott
rash, night sweats pruritus
raxx, għaraq matul il- lejl ħakk
myalgia
mijalġja
Renal and urinary disorders:
Disturbi fil- kliewi u fis- sistema urinarja
blood creatinine increased
żieda fil- krejatinina tad- demm
breast enlargement
tkabbir fis- sider
fatigue, energy increased feeling abnormal, feeling jittery, chills
għeja kbira, żieda fl- enerġija tħossok anormali, tħossok nervuż/ a, tertir ta ’ bard
Adverse reactions from clinical study experience with efavirenz + emtricitabine + tenofovir disoproxil fumarate The following data are derived from a clinical study (GS-01-934) in which efavirenz, emtricitabine and tenofovir disoproxil fumarate were co-administered without regard to food as individual formulations or as a dual fixed combination of emtricitabine and tenofovir disoproxil fumarate with efavirenz.
Reazzjonijiet avversi mill- esperjenza minn studji kliniċi dwar efavirenz + emtricitabine + tenofovir disoproxil fumarate Id- dejta li ġejja hija meħuda minn studju kliniku (GS- 01- 934) fejn efavirenz, emtricitabine u tenofovir disoproxil fumarate kienu ko- amministrati mingħajr ma jingħata kas tal- ikel bħala formulazzjonijiet individwali jew bħala kombinazzjoni fissa doppja ta ’ emtricitabine u tenofovir disoproxil fumarate ma ’ efavirenz.
Selected treatment-emergent adverse reactions considered possibly or probably related to study drugs from this study reported in patients after 144 weeks of treatment are listed by body system organ class and frequency in Table 3.
20 Ir- reazzjonijiet avversi magħżula li ħarġu mit- trattament ikkunsidrati bħala possibbilment jew probabbilment relatati mal- mediċini ta ’ l- istudju minn dan l- istudju f’ pazjenti wara 144 ġimgħa ta ’ trattament huma elenkati skond is- sistema tal- klassifika ta ’ l- organi tal- ġisem u l- frekwenza f’ Tabella 3.
Selected treatment-emergent adverse reactions considered possibly or probably related to study drugs (efavirenz, emtricitabine and tenofovir disoproxil fumarate) in clinical study GS-01-934 over 144 weeks
Reazzjonijiet avversi magħżula li ħarġu mit- trattament ikkunsidrati bħala possibbilment jew probabbilment relatati mal- mediċini ta ’ l- istudju (efavirenz, emtricitabine u tenofovir disoproxil fumarate) fl- istudju kliniku GS- 01- 934 fuq perijodu ta ’ 144 ġimgħa.
Efavirenz+emtricitabine+tenofovir disoproxil fumarate (n=257) Blood and lymphatic system disorders:
Efavirenz+emtricitabine+tenofovir disoproxil fumarate (n=257) Disturbi tad- demm u tas- sistema limfatika:
neutropenia
newtropenja
dizziness somnolence, stupor, lethargy, headache, disturbance of attention
sturdament somnolenza, sturdament, letarġija, uġigħ ta ’ ras, disturb ta ’ l- attenzjoni
amnesia, ataxia, balance disorder, dysgeusia
amnesija, atassja, disturb tal- bilanċ, disgewżja
Ear
Mhux komuni
Uncommon and labyrinth disorders:
Disturbi fil- widnejn u fis- sistema labirintika:
vision blurred vertigo
vertiġini
nausea diarrhoea, vomiting, abdominal pain, flatulence, abdominal distension, dry mouth
dardir dijarea, rimettar, uġigħ addominali, gass fl- istonku, distensjoni addominali, ħalq xott
dyspepsia
dispepsja
rash pruritus, skin hyperpigmentation, dermatitis urticaria, dry skin, eczema
raxx ħakk, pigmentazzjoni eċċessiva tal- ġilda, dermatite urtikarja, ġilda xotta, ekżema
decreased appetite, increased appetite hypertriglyceridaemia, anorexia
tnaqqis fl- aptit, żieda fl- aptit ipertrigliċeridimja, anoressja
hot flush
fwawar tal- menopawsa
20 Efavirenz+emtricitabine+tenofovir disoproxil fumarate (n=257) General disorders and administration site conditions:
Disturbi ġenerali u kundizzjonijiet ta ’ mnejn jingħata:
fatigue, fever asthenia, feeling drunk
għeja kbira, deni astenja, sensazzjoni ta ’ sakra
abnormal dreams nightmares, depression, insomnia, sleep disorder, euphoric mood
ħolm anormali ħmar il- lejl, depressjoni, insomnja, disturb fl- irqad, burdata ewforika
paranoia, psychomotor agitation, delusion, confusional state, anxiety, aggression, nervousness, disorientation
paranojja, aġitazzjoni psikomotorili, delużjoni, stat ta ’ konfużjoni, ansjetà, aggressjoni, nervożità, diżorjentament
Liver enzymes: in a 144-week clinical study (GS-01-934), elevations of aspartate aminotransferase (AST > 5 times ULN (upper limit of normal)) and of alanine aminotransferase (ALT > 5 times ULN) were reported in 3% and 2% of patients treated with efavirenz, emtricitabine, and tenofovir disoproxil fumarate (n=257) and 3% and 3% of patients treated with efavirenz and fixed-dose zidovudine/ lamivudine (n=254), respectively.
Enzimi tal- fwied: fi studju kliniku (GS- 01- 934) ta ’ 144 ġimgħa, żidiet ta ’ aspartate aminotransferase (AST > 5 darbiet ULN (limitu ta ’ fuq tan- normal)) u ta ’ alanine aminotransferase (ALT > 5 darbiet ULN) kienu rrapportati fi 3% u fi 2% tal- pazjenti
Adverse reactions associated with the individual components of Atripla The adverse reactions from clinical study and post-marketing experience with the individual components of Atripla in antiretroviral combination therapy are listed in Table 4 below by body system organ class and frequency.
Reazzjonijiet avversi marbuta mal- komponenti individwali ta ’ Atripla Ir- reazzjonijiet avversi minn studju kliniku u l- esperjenza ta ’ wara t- tqegħid fis- suq b’ komponenti individwali ta ’ Atripla f’ terapija antiretrovirali kkumbinata huma elenkati f’ Tabella 4 hawn taħt bis - sistema tal- klassifika ta ’ l- organi tal- ġisem u l- frekwenza.
The most notable adverse reactions that have been reported in clinical studies with efavirenz are rash and nervous system symptoms.
L- iktar reazzjonijiet avversi notevoli li kienu rrappurtati fl- istudji kliniċi b’ efavirenz huma raxx u sintomi fis- sistema nervuża.
The administration of efavirenz with food may increase efavirenz exposure and may lead to an increase in the frequency of adverse reactions (see section 4.4).
L- għoti ta ’ efavirenz mal- ikel jista ’ jżid l- esponiment għal efavirenz u jista ’ jwassal għal żieda fil- frekwenza ta ’ reazzjonijiet avversi (ara sezzjoni 4. 4).
There have been post-marketing reports in association with tenofovir disoproxil fumarate of renal and urinary disorders including renal failure, proximal tubulopathy (including Fanconi syndrome), acute tubular necrosis and nephrogenic diabetes insipidus.
Kien hemm rapporti ta ’ wara t- tqegħid fis- suq b’ rabta ma ’ tenofovir disoproxil fumarate ta ’ disturbi renali u urinarji li jinkludu insuffiċjenza renali, tubulopatija prossimali (li tinkludi s- sindrome ta ’ Fanconi), nekrosi tubulari akuta u dijabete insipidus nefroġenika.
Adverse reactions associated with the individual components of Atripla based on clinical study and post-marketing safety experience
Reazzjonijiet avversi assoċjati ma ’ komponenti individwali ta ’ Atripla bbażati fuq studju kliniku u l- esperjenza tas- sigurtà ta ’ wara t- tqegħid fis- suq
Blood and lymphatic system disorders:
Disturbi tad- demm u tas- sistema
Common Uncommon Nervous system disorders:
Komuni Mhux komuni Disturbi fis- sistema nervuża:
neutropenia anaemia
newtropenja anemija
Very common Common somnolence, headache, disturbance in attention, dizziness Uncommon convulsions, amnesia, thinking abnormal, ataxia, coordination abnormal, agitation Not known* cerebellar coordination and balance disturbances Eye disorders:
Komuni ħafna Komuni somnolenza, uġigħ ta ’ ras, disturb ta ’ l - attenzjoni, sturdament Mhux komuni aċċessjonijiet, amnesija, ħsibijiet anormali, atassja, ko - ordinazzjoni anormali, aġitazzjoni Mhux magħruf * disturbi ċelebrali tal - koordinazzjoni u tal - bilanċ Disturbi fl- għajnejn:
Uncommon vision blurred Ear and labyrinth disorders:
Mhux komuni vista mċajpra Disturbi fil- widnejn u fis- sistema labirintika:
Uncommon vertigo
Mhux komuni vertiġini Disturbi respiratorji, toraċiċi u medjastinali:
headache dizziness
uġigħ ta ’ ras sturdament
21
Mhux magħruf * Disturbi gastro- intestinali:
Emtricitabine
qtugħ ta ’ nifs
Tenofovir disoproxil fumarate
Komuni ħafna Komuni dijarea, rimettar, uġigħ addominali, dardir Mhux komuni pankreatite akuta
Not known* Gastrointestinal disorders:
dijarea, dardir amylase għolja inkluża amylase pankreatika għolja, lipase fis- serum għoli, rimettar, uġigħ addominali, dispepsja
dyspnoea
dijarea, rimettar, dardir gass fl- istonku
Very common
Mhux magħruf *
diarrhoea, nausea
pankreatite
diarrhoea, vomiting, nausea
22
Common diarrhoea, vomiting, abdominal pain, nausea Uncommon pancreatitis acute
Efavirenz
elevated amylase including elevated pancreatic amylase, elevated serum lipase, vomiting, abdominal pain, dyspepsia
Emtricitabine
flatulence
Tenofovir disoproxil fumarate
Not known* Renal and urinary disorders:
Disturbi fil- kliewi u fis- sistema
pancreatitis
urinarja:
Not known* Skin and subcutaneous tissue disorders:
Mhux magħruf * Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda:
Very common rash (all grades, 18%)
Komuni ħafna raxx (gradi kollha, 18%)
renal failure (acute and chronic), acute tubular necrosis, proximal renal tubulopathy including Fanconi syndrome, nephritis, acute interstitial nephritis, nephrogenic diabetes insipidus, increased creatinine, proteinuria
insuffiċjenza renali (akuta u kronika), nekrosi tubulari akuta, tubulopatija renali prossimali inkluż is - sindromu Fanconi, nefrite, nefrite interstizjali akuta, dijabete insipidus nefroġenika, krejatinina miżjuda, proteinurja
Common pruritus Uncommon Stevens-Johnson syndrome, erythema multiforme, severe rash (< 1%)
Komuni ħakk Mhux komuni sindromu Stevens - Johnson, eritema multiforme, raxx sever (< 1%)
allergic reaction, vesiculobullous rash, pustular rash, maculopapular rash, rash, pruritus, urticaria, skin discolouration (increased pigmentation)
reazzjoni allerġika, raxx vesikulobulluż, raxx pustulari, raxx makulopapulari, raxx, ħakk, urtikarja, tidnis tal- kulur tal- ġilda (pigmentazzjoni miżjuda)
Not known* photoallergic dermatitis Musculoskeletal and connective tissue disorders:
Mhux magħruf * dermatite fotoallerġika Disturbi muskolu- skeltrali u tal- connective tissue:
Very common Not known* Metabolism and nutrition disorders:
Komuni ħafna Mhux magħruf * Disturbi fil- metaboliżmu u n- nutrizzjoni:
elevated creatine kinase
creatine kinase elevat
rhabdomyolysis, osteomalacia (manifested as bone pain and infrequently contributing to fractures), muscular weakness, myopathy
rabdomijolosi, osteomalaċja (li tidher bħala wġigħ fl- għadam u b’ mod mhux frekwenti tikkontribwixxi għal ksur), dgħjufija fil - muskoli, mijopatija
hyperglycaemia, hypertriglyceridaemia
ipergliċemija, ipertrigliċeridimja
Not known*
Mhux magħruf *
lactic acidosis, hypokalaemia
aċidożi lattika, ipokalimja
22
Komuni Mhux magħruf *
Efavirenz
għeja kbira
Emtricitabine
uġigħ, astenja
Tenofovir disoproxil fumarate
astenja
General disorders and administration site conditions:
Disturbi fis- sistema immuni:
Common Not known*
Mhux komuni
fatigue
sensittività eċċessiva
Uncommon
Emtricitabine
hypersensitivity
Tenofovir disoproxil fumarate
elevated serum aspartate aminotransferase (AST) and/ or elevated serum alanine aminotransferase (ALT), hyperbilirubinaemia
aspartate aminotransferase (AST) fis- serum għolja u/ jew alanine aminotransferase (ALT) fis- serum għolja, iperbilirubinimja
hepatic failure
insuffiċjenza tal- fwied
hepatitis, increased transaminases, hepatic steatosis
epatite, transaminases miżjuda, stejatożi epatika
Uncommon Psychiatric disorders:
Mhux komuni Disturbi psikjatriċi:
depression (severe in 1.6%), anxiety, abnormal dreams, insomnia
depressjoni (severa f ’ 1. 6%), ansjetà, ħolm anormali, insomnja
abnormal dreams, insomnia
ħolm anormali, insomnja
suicide attempt, suicide ideation, mania, paranoia, hallucination, euphoric mood, affect lability, confusional state, aggression
attentat ta ’ suwiċidju, ideat dwar suwiċidju, manija, paranojja, alluċinazzjoni, burdata ewforika, labilità ta ’ l - affett, stat konfużjonali, aggressjoni
completed suicide, psychosis, delusion, neurosis
suwiċidju komplut, psikożi, delużjoni, nevrożi
* These adverse reactions have been identified through post-marketing safety surveillance and the frequency is not known.
* Dawn ir- reazzjoniiet avversi ġew identifikati mis- sorveljanza tas- sigurtà ta ’ wara t- tqegħid fis- suq u l- frekwenza mhix maghrufa.
The following adverse reactions, listed under the body system headings above, may occur as a consequence of proximal renal tubulopathy: rhabdomyolysis, osteomalacia (manifested as bone pain and infrequently contributing to fractures), hypokalaemia, muscular weakness, myopathy and hypophosphataemia.
Ir- reazzjonijiet avversi li ġejjin, elenkati taħt l- intestaturi tas- sistema tal- ġisem hawn fuq, jistgħu jseħħu bħala konsegwenza ta ’ tubulopatija renali prossimali: rabdomijolosi, osteomalaċja (li tidher bħala wġigħ fl- għadam u b’ mod mhux frekwenti tikkontribwixxi għal ksur), ipokalimja, dgħjufija fil - muskoli, mijopatija u ipofosfatimja.
These events are not considered to be causally associated with tenofovir disoproxil fumarate therapy in the absence of proximal renal tubulopathy.
Dawn l- avvenimenti mhumiex ikkunsidrati li huma assoċjati b’ mod kawżali mat- terapija b’ tenofovir disoproxil fumarate fl- assenza ta ’ tubulopatija renali prossimali.
Rash with efavirenz: rashes are usually mild-to-moderate maculopapular skin eruptions that occur within the first two weeks of initiating therapy with efavirenz.
Raxx b’ efavirenz: ir- raxxijiet ġeneralment huma eruzzjonijiet tal- ġilda makulopapulari ħfief għal moderati li jseħħu fi żmien l- ewwel ġimagħtejn li tinbeda terapija b’ efavirenz.
In most patients rash resolves with continuing therapy with efavirenz within one month.
Fil- biċċa l- kbira tal - pazjenti r- raxx jirrisolvi fi żmien xahar bi tkomplija tat- terapija b’ efavirenz.
In clinical studies, 1.7% of patients treated with efavirenz discontinued therapy because of rash.
Fi studji kliniċi, 1. 7% tal - pazjenti ttrattati b’ efavirenz waqqfu t- terapija minħabba r- raxx.
Efavirenz can be reinitiated in patients interrupting therapy because of rash.
Efavirenz jista ’ jerġa ’ jinbeda f’ pazjenti li jkunu interrompew it- terapija minħabba raxx.
Use of appropriate antihistamines and/ or corticosteroids is recommended when efavirenz is restarted.
Użu ta ’ antistamini adattati u/ jew kortikosterojdi huwa rrikkmandat meta jerġa ’ jinbeda efavirenz.
Experience with efavirenz in patients who discontinued other antiretroviral agents of the non-nucleoside reverse transcriptase inhibitor (NNRTI) class is limited.
L- esperjenza b’ efavirenz f’ pazjenti li waqqfu sustanzi antiretrovirali oħra tal- klassi ta ’ inibituri non- nucleoside reverse transcriptase (NNRTI) hija limitata.
Nineteen patients who discontinued nevirapine because of rash have been treated with efavirenz.
Dsatax- il pazjent li waqqfu nevirapine minħabba raxx ġew ittrattati b’ efavirenz.
23 developed mild-to-moderate rash while receiving therapy with efavirenz, and two discontinued because of rash.
Disgħa minn dawn il- pazjenti żviluppaw raxx ħafif għal moderat waqt li qegħdin jirċievu terapija b’ efavirenz, u tnejn waqfu minħabba raxx.
Psychiatric symptoms with efavirenz: patients with a history of psychiatric disorders appear to be at greater risk of serious psychiatric adverse reactions listed in the efavirenz column of Table 4 with the frequency of events ranging from 0.3% for manic reactions to 2.0% for both severe depression and suicidal ideation.
Sintomi psikjatriċi b’ efavirenz: pazjenti bi storja ta ’ disturbi psikjatriċi jidhru li huma f’ riskju akbar ta ’ reazzjonijiet avversi psikjatriċi serji elenkati fil- kolonna ta ’ efavirenz f’ Tabella 4 bil- frekwenza
Nervous system symptoms with efavirenz: in clinical controlled studies, nervous system symptoms of moderate-to-severe intensity were experienced by 19.4% of patients compared to 9.0% of patients receiving control regimens.
Sintomi tas- sistema nervuża b’ efavirenz: fi studji kliniċi kkontrollati, sintomi tas- sistema nervuża ta ’ intensità moderata għal severa kienu esperjenzati minn 19. 4% tal- pazjenti meta mqabbla ma ’ 9. 0% tal- pazjenti li qegħdin jirċievu reġimens ta ’ kontroll.
These symptoms were severe in 2.0% of patients receiving efavirenz 600 mg daily and in 1.3% of patients receiving control regimens.
Dawn is- sintomi kienu severi fi 2. 0% tal- pazjenti li kienu qed jirċievu efavirenz 600 mg kuljum u f’ 1. 3% tal- pazjenti li kienu qed jirċievu korsijiet ta ’ kontroll.
In clinical studies 2.1% of patients treated with 600 mg of efavirenz discontinued therapy because of nervous system symptoms.
Fi studji kliniċi, 2. 1% tal- pazjenti ttrattati b’ 600 mg ta ’ efavirenz waqqfu t- terapija minħabba sintomi tas- sistema nervuża.
Nervous system symptoms usually begin during the first one or two days of therapy and generally resolve after the first two to four weeks.
Is- sintomi tas- sistema nervuża ġeneralment jibdew matul l- ewwel jum jew jumejn ta ’ terapija u ġeneralment jirrisolvu wara l- ewwel żewġ sa erba ’ ġimgħat.
Nervous system symptoms may occur more frequently when efavirenz is taken concomitantly with meals possibly due to increased efavirenz plasma levels (see section 5.2).
Is- sintomi tas- sistema nervuża jistgħu jseħħu aktar frekwentement meta efavirenz jittieħed fl- istess ħin ma ’ l- ikliet possibbilment minħabba livelli ogħla ta ’ efavirenz fil- plażma (ara sezzjoni 5. 2).
Dosing at bedtime seems to improve the tolerability of these symptoms (see section 4.2).
Dożar fil- ħin ta ’ l- irqad jidher li jtejjeb it - tollerabilità ta ’ dawn is- sintomi (ara sezzjoni 4. 2).
Analysis of long-term data from a clinical study (median follow-up 180 weeks, 102 weeks and 76 weeks for patients treated with efavirenz + zidovudine + lamivudine, efavirenz + indinavir, and indinavir + zidovudine + lamivudine, respectively) showed that, beyond 24 weeks of therapy, the incidences of new-onset nervous system symptoms among efavirenz-treated patients were generally similar to those in the control arm.
Analiżi ta ’ dejta minn studju kliniku fuq tul ta ’ żmien (follow- up medjan ta ’ 180 ġimgħa, 102 ġimgħat u 76 ġimgħa għal pazjenti ttrattati b’ efavirenz + zidovudine + lamivudine, efavirenz + indinavir, u indinavir + zidovudine + lamivudine, rispettivament) urew li, ‘ l hinn minn 24 ġimgħa ta ’ terapija, il - bidu ġdid ta ’ inċidenzi ta ’ sintomi tas- sistema nervuża fost pazjenti ttrattati b’ efavirenz kienu ġeneralment simili għal dawk fid- driegħ ta ’ kontroll.
Lactic acidosis: lactic acidosis, usually associated with hepatic steatosis, has been reported with the use of nucleoside analogues (see section 4.4).
Aċidożi lattika: aċidożi lattika, ġeneralment assoċjata ma ’ stejatożi epatika, ġiet irrapportata bl- użu ta ’ analogi tan- nukleosidi (ara sezzjoni 4. 4).
Only a limited number of patients were co-infected with HBV (n=13) or HCV (n=26) in study GS-01-934.
Pazjenti ko- infettati bl- HIV/ HBV jew HCV: numru limitat biss ta ’ pazjenti kienu ko- infettati bl- HBV (n=13) jew bl- HCV (n=26) fi studju GS- 01- 934.
The adverse reaction profile of efavirenz, emtricitabine and tenofovir disoproxil fumarate in patients co-infected with HIV/ HBV or HIV/ HCV was similar to that observed in patients infected with HIV without co-infection.
Il- profil tar- reazzjonijiet avversi ta ’ efavirenz, emtricitabine u tenofovir disoproxil fumarate f’ pazjenti ko- infettati bl- HIV/ HBV jew bl- HIV/ HCV kien jixbah lil dak osservat f’ pazjenti infettati bl- HIV mingħajr ko- infezzjoni.
However, as would be expected in this patient population, elevations in AST and ALT occurred more frequently than in the general HIV infected population.
Madankollu, kif inhu mistenni f’ din il- popolazzjoni ta ’ pazjenti, żidiet f’ AST u ALT seħħew aktar frekwentement milli fil - popolazzjoni infettata b’ HIV ġenerali.
Amylase: in clinical studies, asymptomatic increases in serum amylase levels > 1.5 times the ULN were seen in 10% of patients treated with efavirenz and 6% of patients treated with control regimens.
Amylase: fi studji kliniċi, żidiet asintomatiċi fil- livelli ta ’ amylase fis- serum > 1. 5 darbiet l- ULN dehru f’ 10% tal- pazjenti ttrattati b’ efavirenz u 6% tal- pazjenti ttrattati b’ reġimens ta ’ kontroll.
The clinical significance of asymptomatic increases in serum amylase is unknown.
Is - sinifikat kliniku ta ’ żidiet asintomatiċi fl- amylase fis- serum mhux magħruf.
Lipids, lipodystrophy and metabolic abnormalities: combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin-resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
Lipidi, lipodistrofija u anormalitajiet metaboliċi: terapija antiretrovirali kkumbinata ġiet assoċjata ma ’ anormalitajiet metaboliċi bħalma huma ipertrigliċeridimja, iperkolesterolimja, reżistenza għall - insulina, ipergliċemija u iperlaktatemija (ara sezzjoni 4. 4).
Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV patients including the loss of peripheral and facial subcutaneous fat, increased intra-abdominal and visceral fat, breast hypertrophy and dorsocervical fat accumulation (buffalo hump) (see section 4.4).
Terapija antiretrovirali kkumbinata ġiet assoċjata ma ’ distribuzzjoni mill- ġdid tax- xaħam tal- ġisem (lipodistrofija) f’ pazjenti b’ HIV inklużi t- telf ta ’ xaħam ta ’ taħt il- ġilda periferali u tal- wiċċ, żidiet fix - xaħam intra- addominali u vixxerali, ipertrofija tas- sider u akkumulazzjoni ta ’ xaħam dorsoċervikali (ħotba tal- buflu) (ara sezzjoni 4. 4).
Immune Reactivation Syndrome: in HIV infected patients with severe immune deficiency at the time of initiation of CART, an inflammatory reaction to asymptomatic or residual opportunistic infections may arise (see section 4.4).
Sindromu ta ’ l- Attivazzjoni Immunitarja mill- Ġdid: f’ pazjenti infettati bl- HIV b’ defiċjenza immunitarja severa fiż- żmien tal- bidu ta ’ CART, tista ’ tqum reazzjoni infjammatorja għal infezzjonijiet asintomatiċi jew reżidwi opportunistiċi (ara sezzjoni 4. 4).
Cannabinoid test interaction: efavirenz does not bind to cannabinoid receptors.
Interazzjoni tat- test kannabinojde: efavirenz ma jeħilx ma ’ riċetturi kannabinojde.
False positive urine cannabinoid test results have been reported in uninfected volunteers who received efavirenz.
Riżultati pożittivi foloz ta ’ testijiet kannabinojde ta ’ l- awrina ġew irrapportati f’ voluntieri mhux infettati li rċevew efavirenz.
False positive test results have only been observed with the CEDIA DAU Multi-Level THC assay, which is
Testijiet pożittivi foloz ġew osservati biss bl- assaġġ CEDIA DAU Multi- Level THC, li jintuża għal screening, u ma ġewx osservati b’ assaġġi kannabinojde ttestjati fosthom testijiet użati għall- konferma ta ’ riżultati pożittivi.
Osteonecrosis: cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART).
25 Osteonekrosi: kienu rrappurtati każijiet ta ’ osteonekrosi, partikolarment f’ pazjenti b’ fatturi ta ’ riskju ġeneralment rikonoxxuti, mard ta ’ l- HIV avanzat jew esponiment fuq tul ta ’ żmien għal terapija antiretrovirali kkumbinata (CART).
Some patients accidentally taking 600 mg efavirenz twice daily have reported increased nervous system symptoms.
Xi pazjenti li aċċidentalment ħadu 600 mg efavirenz darbtejn kuljum irrapportaw żidiet fis- sintomi tas- sistema nervuża.
One patient experienced involuntary muscle contractions.
Pazjent esperjenza kontrazzjonijiet involontarji tal- muskoli.
If overdose occurs, the patient must be monitored for evidence of toxicity (see section 4.8), and standard supportive treatment applied as necessary.
Jekk tittieħed doża eċċessiva, il- pazjent għandu jiġi sorveljat għal evidenza ta ’ tossiċità (ara sezzjoni 4. 8) u jiġi applikat trattament ta ’ sostenn standard kif meħtieġ.
Administration of activated charcoal may be used to aid removal of unabsorbed efavirenz.
Jista ’ jintuża l- għoti ta ’ faħam attivat biex jgħin fit- tneħħija ta ’ efavirenz mhux assorbit.
There is no specific antidote for overdose with efavirenz.
Ma hemm l - ebda antidotu speċifiku għal doża eċċessiva b’ efavirenz.
Since efavirenz is highly protein bound, dialysis is unlikely to remove significant quantities of it from blood.
Peress li efavirenz jeħel ħafna mal- proteini tad- demm, dijalisi x’ aktarx li ma tneħħix kwantitajiet sinifikattivi minnu mid- demm.
Up to 30% of the emtricitabine dose and approximately 10% of the tenofovir dose can be removed by haemodialysis.
Sa 30% tad- doża ta ’ emtricitabine u madwar 10% tad- doża ta ’ tenofovir tista ’ titneħħa permezz ta ’ emodijalisi.
It is not known whether emtricitabine or tenofovir can be removed by peritoneal dialysis.
Mhux magħruf jekk emtricitabine jew tenofovir jistgħux jitneħħew permezz ta ’ dijalisi peritonejali.
Antivirals for treatment of HIV infections, combinations, ATC code:
Antivirali għat- trattament ta ’ infezzjonijiet, kombinazzjonijiet tal- HIV, Kodiċi ATC:
Mechanism of action: efavirenz is an NNRTI of HIV-1.
Mekkaniżmu ta ’ azzjoni: efavirenz huwa NNRTI of HIV- 1.
Efavirenz non-competitively inhibits HIV-1 reverse transcriptase (RT) and does not significantly inhibit human immunodeficiency virus-2 (HIV-2) RT or cellular deoxyribonucleic acid (DNA) polymerases (α, β, γ, and δ).
Efavirenz jinibixxi b’ mod mhux kompetittiv HIV- 1 reverse transcriptase (RT) u ma jinibixxix b’ mod sinifikanti human immunodeficiency virus- 2 (HIV- 2) RT jew cellular deoxyribonucleic acid (DNA) polymerases (α, β, γ, and δ).
Emtricitabine is a nucleoside analogue of cytidine.
Emtricitabine huwa nucleoside analogue ta ’ cytidine.
Tenofovir disoproxil fumarate is converted in vivo to tenofovir, a nucleoside monophosphate (nucleotide) analogue of adenosine monophosphate.
Tenofovir disoproxil fumarate jinqeleb in vivo f’ tenofovir, analogue ta ’ nucleoside monophosphate (nucleotide) ta ’ adenosine monophosphate.
Emtricitabine and tenofovir are phosphorylated by cellular enzymes to form emtricitabine triphosphate and tenofovir diphosphate, respectively.
Emtricitabine u tenofovir huma fosforilati minn enzimi ċellulari sabiex jifformaw emtricitabine triphosphate u tenofovir diphosphate, rispettivament.