FrancophonIA/ELRC3.0 huggingface dataset:
English: Each Atripla film-coated tablet contains 600 mg of efavirenz, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (as fumarate).
Maltese: Kull pillola miksija b'rita fiha 600 mg ta' efavirenz, 200 mg ta' emtricitabine u 245 mg ta' tenofovir disoproxil (bħala fumarate).
English: Renal clearance has been estimated to be approximately 210 ml/min, which is in excess of the glomerular filtration rate.
Maltese: eliminazzjoni mill-kliewi kienet stmata bħala bejn wieħed u ieħor 210 ml/min, li hija aktar mir-rata ta' filtrazzjoni glomerulari.
English: AUC: ↓ 34% (↓ 21 to ↓ 41) Cmax: ↓ 20% (↓ 2 to ↓ 26)
Maltese: ↓ 34% (↓ 21 għal ↓ 41) Cmax: ↓ 20% (↓ 2 għal ↓ 26)
English: Pharmacotherapeutic group: Antiviral for systemic use, antivirals for treatment of HIV infections, combinations, ATC code: J05AR06
Maltese: infezzjonijiet, kombinazzjonijiet tal-HIV, Kodiċi ATC:
English: • allergic reaction (hypersensitivity) that may cause severe skin reactions (Stevens-Johnson syndrome, erythema multiforme, see section 2)
Maltese: (sindromu ta' Stevens-Johnson, eritema multiformi, ara sezzjoni 2)
English: Concomitant use of Ginkgo biloba extracts is not recommended (see section 4.4).
Maltese: estratti ta' Ginkgo biloba mhux irrikkmandat (ara sezzjoni 4.4).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il portal elettroniku Ewropew tal-mediċini.
English: This is equivalent to 1.2% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 1.2% tal-ammont massimu rakkomandat ta' sodium li għandu jittieħed kuljum mad-dieta minn adult.
English: AUC: ↓ 13% Cmin: ↓ 31% Cmax: ↓ 15%
Maltese: AUC: ↓ 13% Cmin: ↓ 31%
English: The apparent clearance of tenofovir averaged approximately 307 ml/min.
Maltese: L-eliminazzjoni apparenti ta' tenofovir kellha medja ta' bejn wieħed u ieħor 307 ml/min. L
English: There is a potential for reduction or increase in the plasma concentrations of phenytoin, phenobarbital and other anticonvulsants that are substrates of CYP isozymes with efavirenz.
Maltese: Hemm potenzjal għal tnaqqis fil-konċentrazzjonijiet tal-plażma ta' phenytoin, phenobarbital u antikonvulsivi oħra li huma sottostrati ta' isozimi ta' CYP b'efavirenz.
English: Up to 30% of the emtricitabine dose and approximately 10% of the tenofovir dose can be removed by haemodialysis.
Maltese: Sa 30% tad-doża ta' emtricitabine u madwar 10% tad-doża ta' tenofovir tista' titneħħa permezz ta' emodijalisi.
English: Gilead Sciences Sweden AB Puh/Tel: + 46 (0) 8 5057 1849
Maltese: Puh/Tel: + 46 (0) 8 5057 1849
English: Co-administration of Atripla and didanosine is not recommended (see section 4.4).
Maltese: Atripla u didanosine mhuwiex rakkomandat (ara sezzjoni 4.4).
English: It is recommended that Atripla be taken on an empty stomach since food may increase efavirenz exposure and may lead to an increase in the frequency of adverse reactions (see sections 4.4 and 4.8).
Maltese: efavirenz u jwassal għal żieda fil-frekwenza tar-reazzjonijiet avversi (ara sezzjonijiet 4.4 u 4.8).
English: There were no clinically significant pharmacokinetic interactions when emtricitabine was administered with stavudine, zidovudine or famciclovir.
Maltese: Ma kien hemm ebda interazzjoni farmakokinetika klinikament sinifikanti meta emtricitabine ngħata ma' stavudine, zidovudine jew famciclovir.
English: Although in vitro data suggest that efavirenz inhibits CYP2C9 and CYP2C19, there have been contradictory reports of both increased and decreased exposures to substrates of these enzymes when co-administered with efavirenz in vivo.
Maltese: Għalkemm dejta in vitro tissuġġerixxi li efavirenz jinibixxi CYP2C9 u CYP2C19, kien hemm rapporti kontradittorji kemm ta' żidiet kif ukoll ta' tnaqqis fl-esponimenti għas-substrati ta' dawn l-enzimi meta jingħataw flimkien ma' efavirenz in vivo.
English: It is anticipated that tenofovir exposure (AUC) will be approximately 30% lower following administration of Atripla on an empty stomach as compared to the individual component tenofovir disoproxil when taken with food (see section 5.1).
Maltese: Huwa mistenni li l-espożizzjoni ta' tenofovir (AUC) tkun bejn wieħed u ieħor 30% inqas wara għoti ta' Atripla fuq stonku vojt meta mqabbel mal-komponenti individwali tenofovir disoproxil meta meħud mal-ikel (ara sezzjoni 5.1).
English: However, there was no increased risk of fractures or evidence for clinically relevant bone abnormalities over 144 weeks.
Maltese: Madankollu, ma kienx hemm riskju akbar ta' ksur jew evidenza ta' anormalitajiet fl-għadam klinikament rilevanti matul 144 ġimgħa.
English: In vitro and clinical pharmacokinetic interaction studies have shown the potential for CYP-mediated interactions involving emtricitabine and tenofovir disoproxil with other medicinal products is low.
Maltese: Studji tal-interazzjonijiet farmakokinetiċi in vitro u kliniċi wrew li l-potenzjal għal interazzjonijiet medjati minn CYP li jinvolvu emtricitabine u tenofovir disoproxil ma' prodotti mediċinali oħrajn huwa wieħed baxx.
English: (competitive inhibition of oxidative metabolism)
Maltese: ↑ 38% (inibizzjoni kompetittiva ta' metaboliżmu ossidattiv)
English: Rare events of renal impairment, renal failure and uncommon events of proximal renal tubulopathy (including Fanconi syndrome) sometimes leading to bone abnormalities (infrequently contributing to fractures) have also been reported.
Maltese: Avvenimenti rari ta' indeboliment renali, insuffiċjenza renali u avvenimenti mhux komuni ta' tubulopatija renali prossimali (inkluż is-sindromu ta' Fanconi) li xi kultant iwasslu għal anormalitajiet tal-għadam (li b'mod mhux frekwenti jikkontribwixxu għal ksur) kienu wkoll irrappurtati.
English: Cmax: ↓ 28% (↓ 7 to ↓ 44) Cmin: ↓ 37% (↓ 17 to ↓ 52)
Maltese: ↓ 37% (↓ 17 għal ↓ 52) Cmax: ↓ 28% (↓ 7 għal ↓ 44) Cmin: ↓ 37% (↓ 17 għal ↓ 52)
English: Atripla is contraindicated in patients with severe hepatic impairment (see section 4.3) and not recommended in patients with moderate hepatic impairment.
Maltese: Atripla hija kontra-indikata f'pazjenti b'indeboliment epatiku sever (ara sezzjoni 4.3) u mhijiex rakkomandata f'pazjenti b'indeboliment epatiku moderat.
English: Mild-to-moderate rash has been reported with the individual components of Atripla.
Maltese: Raxx ħafif għal moderat ġie rrapportat bil-komponenti individwali ta' Atripla.
English: Based on the concentration-QTc relationship, the mean QTc prolongation and its upper bound 90% confidence interval are 8.7 ms and 11.3 ms in subjects with CYP2B6*6/*6 genotype following the administration of 600 mg daily dose for 14 days
Maltese: tiegħu huma ta' 8.7 ms u 11.3 ms f'individwi bil-ġenotip CYP2B6 *6/*6 wara l-għoti ta' doża ta' 600 mg kuljum għal 14-il ġurnata (ara sezzjoni 4.5).
English: A similar reduction in indinavir exposures was observed when indinavir 1,000 mg q8h was given with efavirenz 600 mg q.d.
Maltese: Tnaqqis simili fl-espożizzjonijiet għal indinavir ġew osservati meta indinavir 1,000 mg q8h ingħata flimkien ma'
English: AUC: ↑ 81% (↑ 68 to ↑ 94) Cmax: ↑ 77% (↑ 53 to ↑ 104) Cmin: ↑ 121% (↑ 100 to ↑ 143)
Maltese: Cmax: ↑ 77% (↑ 53 sa ↑ 104) Cmin: ↑ 121% (↑ 100 sa ↑ 143)
English: Atripla 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).
Maltese: Atripla ma għandhiex tingħata fl-istess ħin ma' terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, jew ergot alkaloids (eżempju, ergotamine, dihydroergotamine, ergonovine, u methylergonovine), minħabba li l-inibizzjoni tal-metaboliżmu tagħhom tista' twassal għal episodji ta' perikli serji għas-saħħa (ara sezzjoni 4.3).
English: Gilead Sciences Ireland UC Tel: +353 (0) 214 825 999
Maltese: Tel: +353 (0) 214 825 999
English: Implant: Etonogestrel/Efavirenz
Maltese: Etonogestrel/Efavirenz
English: Dizziness was also seen in clinical studies with emtricitabine and tenofovir disoproxil.
Maltese: Sturdament deher ukoll fi studji kliniċi b'emtricitabine u tenofovir disoproxil.
English: Common pruritus vesiculobullous rash, pustular rash, maculopapular rash, rash, pruritus, urticaria, skin discolouration (increased pigmentation)1
Maltese: ħakk, urtikarja, telf talkulur tal-ġilda (żieda fil-pigmentazzjoni)1
English: Atripla is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil fumarate.
Maltese: X'fih Atripla - Is-sustanzi attivi huma efavirenz, emtricitabine u tenofovir disoproxil.
English: In a single-dose study of efavirenz, half-life was doubled in the single patient with severe hepatic impairment (Child-Pugh-Turcotte Class C), indicating a potential for a much greater degree of accumulation.
Maltese: il-half-life irduppjat fl-uniku pazjent b'indeboliment tal-fwied sever (Child-Pugh-Turcotte Klassi Ċ), li jindika potenzjal għal grad ferm akbar ta' akkumulazzjoni.
English: AUC: ↓ 26% (↓ 15 to ↓ 36) Cmax: ↓ 20% (↓ 11 to ↓ 28) Cmin: ↓ 32% (↓ 15 to ↓ 46)
Maltese: AUC: ↓ 26% (↓ 15 għal ↓ 36) Cmax: ↓ 20% (↓ 11 għal ↓ 28) Cmin: ↓ 32% (↓ 15 għal ↓ 46) (Induzzjoni ta' CYP3A4 u CYP2B6)
English: Renal impairment: As Atripla may cause renal damage, monitoring of renal function is recommended (see sections 4.4 and 4.8 Summary of the safety profile).
Maltese: Indeboliment renali: Billi Atripla jista' jikkawża ħsara renali, is-sorveljanza tal-funzjoni renali hi rakkomandata (ara sezzjonijiet 4.4 u 4.8 Sommarju tal-profil tas-sigurtà).
English: As a general rule, it is recommended that HIV infected women do not breast-feed their infants in order to avoid transmission of HIV to the infant.
Maltese: Bħala regola ġenerali, huwa rakkomandat li nisa infettati bl-HIV ma jreddgħux lit-trabi tagħhom sabiex jevitaw li jgħaddu HIV lit-tarbija.
English: - if you are currently taking any of the following medicines (see also “Other Medicines and Atripla”): - astemizole or terfenadine (used to treat hay fever or other allergies) - bepridil (used to treat heart disease) - cisapride (used to treat heartburn) - elbasvir/grazoprevir (used to treat hepatitis C) - ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (used to treat migraines and cluster headaches) - midazolam or triazolam (used to help you sleep)
Maltese: - jekk bħalissa qed tieħu xi mediċini minn dawn li ġejjin (ara wkoll “Mediċini oħra u Atripla”): astemizole jew terfenadine (użati biex jittrattaw il-hay fever jew allerġiji oħra) bepridil (użat biex jittratta mard tal-qalb) cisapride (użat biex jittratta l-ħruq ta' stonku) elbasvir/grazoprevir (użat biex jittratta l-epatite Ċ) alkalojdi tal-ergotina (per eżempju, ergotamine, dihydroergotamine, ergonovine, u methylergonovine) (użati biex jittrattaw emigranji u wġigħ ta' ras tat-tip cluster) - midazolam jew triazolam (użati biex jgħinuk torqod) - pimozide, imipramine, amitriptyline jew clomipramine (użati biex jittrattaw ċerti kundizzjonijiet mentali) - St.
English: Cmin: ↓ 12% (↓ 24 to ↑ 1)
Maltese: Cmin: ↓ 12% (↓ 24 għal ↑ 1) (Induzzjoni ta' CYP3A4)
English: Concomitant use of Ginkgo biloba extracts is not recommended (see section 4.5).
Maltese: L-użu konkomitanti ta' estratti ta' Ginkgo biloba mhux irrikkmandat (ara sezzjoni 4.5).
English: A multiple-dose study of efavirenz showed no significant effect on efavirenz pharmacokinetics in patients with mild hepatic impairment (Child-Pugh-Turcotte Class A) compared with controls.
Maltese: Studju dwar dożi multipli ta' efavirenz ma wera l-ebda effett sinifikanti fuq il-farmakokinetika ta' efavirenz f'pazjenti b'indeboliment tal-fwied ħafif (Child-Pugh-Turcotte Klassi A) meta mqabbel mal-kontrolli.
English: When Atripla is coadministered with an anticonvulsant that is a substrate of CYP isozymes, periodic monitoring of anticonvulsant levels should be conducted.
Maltese: antikonvulsiv li jkun sottostrat ta' isozimi CYP, għandu jsir monitoraġġ perjodiku tal-livelli tal antikonvulsiv.
English: It is anticipated that tenofovir exposure (AUC) will be approximately 30% lower following administration of Atripla on an empty stomach as compared to the individual component tenofovir disoproxil when taken with food (see section 5.2).
Maltese: Huwa mistenni li l-esponiment ta' tenofovir (AUC) ikun madwar 30% aktar baxx wara l-għoti ta' Atripla fuq stonku vojt meta mqabbel mal-komponent individwali tenofovir disoproxil meta mogħti mal-ikel (ara sezzjoni 5.2).
English: Sufficient data on the tolerability of efavirenz with low-dose ritonavir (100 mg, once or twice daily) are not available.
Maltese: M'hemmx biżżejjed informazzjoni disponibbli dwar it tollerabilità ta' efavirenz ma' doża baxxa ta' ritonavir (100 mg, darba jew darbtejn kuljum).
English: - any signs of inflammation or infection.
Maltese: - kwalunkwe sinjali ta' infjammazzjoni jew infezzjoni.
English: Renally eliminated medicinal products: Since emtricitabine and tenofovir are primarily eliminated by the kidneys, co-administration of Atripla with medicinal products that reduce renal function or compete for active tubular secretion (e.g. cidofovir) may increase serum concentrations of emtricitabine, tenofovir and/or the co-administered medicinal products.
Maltese: Prodotti mediċinali eliminati mill-kliewi: Minħabba li emtricitabine u tenofovir huma eliminati b'mod ewlieni mill-kliewi, l-għoti fl-istess ħin ta' Atripla ma' prodotti mediċinali li jnaqqsu l-funzjoni renali jew li jikkompetu għal sekrezzjoni tubulari attiva (eż. cidofovir) jistgħu iżidu l-konċentrazzjonijiet fisserum ta' emtricitabine, tenofovir u/jew il-prodotti mediċinali amministrati fl-istess ħin.
English: - antiarrhythmics of classes IA and III, - neuroleptics, antidepressive agents, - certain antibiotics including some agents of the following classes: macrolides,
Maltese: - newrolettiċi, sustanzi antidepressivi, - ċerti antibijotiċi li jinkludu xi sustanzi mill-klassijiet li ġejjin: macrolides, fluoroquinolones,
English: Protease inhibitors
Maltese: HIV Inibituri tal-protease
English: This effect is due to induction of CYP3A4 or P-gp by efavirenz and may result in loss of therapeutic effect of elbasvir/grazoprevir (see section 4.5).
Maltese: CYP3A4 jew P-gp kkawżat minn efavirenz u jista' jwassal għal telf tal-effett terapewtiku ta' elbasvir/grazoprevir (ara sezzjoni 4.5).
English: 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.
Maltese: 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.
English: Co-administration with herbal preparations containing St. John's wort (Hypericum perforatum) due to the risk of decreased plasma concentrations and reduced clinical effects of efavirenz (see section 4.5).
Maltese: John's wort (Hypericum perforatum) minħabba r-riskju ta' konċentrazzjonijiet fil-plażma mnaqqsa u tnaqqis fl-effetti kliniċi ta' efavirenz
English: False-positive urine cannabinoid test results have been reported with some screening assays in uninfected and HIV infected subjects receiving efavirenz.
Maltese: Riżultati pożittivi foloz ta' testijiet kannabinojde talawrina ġew irrapportati b'xi assaġġi ta' screening f'suġġetti mhux infettati u f'pazjenti infettati bl-HIV li rċevew efavirenz.
English: Cmax: ↑ 11% (↑ 6 to ↑ 16) Cmin: ↔
Maltese: Cmax: ↑ 11% (↑ 6 għal ↑ 16) Cmin: ↔ (Induzzjoni ta' CYP3A4)
English: ANTI-INFECTIVES HIV antivirals
Maltese: ANTI-INFETTIVI
English: The potential for cross-resistance between efavirenz and PIs is low because of the different enzyme targets involved.
Maltese: Il-potenzjal għal kross-reżistenza bejn efavirenz u PIs huwa wieħed baxx minħabba l-miri differenti tal-enzimi involuti.
English: Itraconazole/Efavirenz (200 mg b.i.d./600 mg q.d.)
Maltese: Maraviroc/Efavirenz (100 mg b.i.d./600 mg q.d.)
English: Morning AUC: ↑ 18% (↑ 6 to ↑ 33) Evening AUC: ↔ Morning Cmax: ↑ 24% (↑ 12 to ↑ 38)
Maltese: AUC fil-għodu: ↑ 18% (↑ 6 għal ↑ 33) AUC fil-għaxija: ↔ Cmax fil-għodu: ↑ 24% (↑ 12 għal ↑ 38) Cmax fil-għaxija:
English: The pharmacokinetics of emtricitabine and tenofovir are similar in male and female patients.
Maltese: Il-farmakokinetiċi ta' emtricitabine u tenofovir huma simili f'pazjenti nisa u rġiel.
English: Clinically significant interactions are not expected as simeprevir and emtricitabine are eliminated via different pathways.
Maltese: Mhumiex mistennija interazzjonijiet kliniċi sinifikanti għax simeprevir u emtricitabine jiġi eliminati minn mogħdijiet differenti.
English: Cases of acute renal failure after initiation of high dose or multiple non-steroidal anti-inflammatory drugs (NSAIDs) have been reported in patients treated with tenofovir disoproxil and with risk factors for renal dysfunction.
Maltese: Każijiet ta' kollass tal-kliewi akuta wara l-bidu ta' doża għolja jew mediċini multipli antiinfjammatorji mhux sterojdi (NSAIDs, non-steroidal anti-inflammatory drugs) ġew irrappurtati f'pazjenti kkurati b'tenofovir disoproxil, u b'fatturi ta' riskju għal funzjoni renali ħażina.
English: Also, Atripla should not be taken with any other medicines that contain efavirenz (unless recommended by your doctor), emtricitabine, tenofovir disoproxil, tenofovir alafenamide, or lamivudine or adefovir dipivoxil.
Maltese: Barra minn hekk, Atripla m'għandhiex tittieħed ma' kwalunkwe mediċini oħra li fihom efavirenz (ħlief jekk rakkomandati mit-tabib tiegħek), emtricitabine, tenofovir disoproxil, tenofovir alafenamide, lamivudine jew adefovir dipivoxil.
English: • The M184V/I mutation developed in 2/19 (10.5%) isolates analysed from patients in the efavirenz + emtricitabine + tenofovir disoproxil group and in 10/29 (34.5%) isolates analysed from the efavirenz + lamivudine/zidovudine group (p-value < 0.05, Fisher's Exact test comparing the emtricitabine + tenofovir disoproxil group to the lamivudine/zidovudine group among all subjects).
Maltese: • Il-mutazzjoni M184V/I żviluppat fi 2/19 (10.5%) iżolati analizzati minn pazjenti fil-grupp ta'
English: ANTIDEPRESSANTS
Maltese: IMMUNOSOPPRESSANTI
English: Appropriate antihistamines and/or corticosteroids may improve tolerability and hasten the resolution of rash.
Maltese: Antistamini u/jew kortikosterojdi adattati jistgħu jtejbu t-tollerabilità u jħaffu r-risoluzzjoni tar-raxx.
English: Simvastatin acid:
Maltese: Osteonekrosi:
English: Specific interaction studies have not been performed with efavirenz and NRTIs other than lamivudine, zidovudine and tenofovir disoproxil.
Maltese: Ma sarux studji speċifiċi tal-interazzjoni b'efavirenz u NRTIs oħra għajr lamivudine, zidovudine u tenofovir disoproxil.
English: Efavirenz: There have been seven retrospective reports of findings consistent with neural tube defects, including meningomyelocele, all in mothers exposed to efavirenz-containing regimens (excluding any efavirenz-containing fixed-dose combination tablets) in the first trimester.
Maltese: Kien hemm seba' rapporti retrospettivi ta' sejbiet konsistenti ma' difetti fit-tubu tan nervituri, inkluż meningomajelosil, kollha f'ommijiet esposti għal korsijiet li kien fihom efavirenz (eskluż kwalunkwe pillola ta' kombinazzjoni ta' doża fissa li fiha efavirenz) fl-ewwel trimestru.
English: Barrier contraception should always be used in combination with other methods of contraception (for example, oral or other hormonal contraceptives, see section 4.5) while on therapy with Atripla.
Maltese: Kontraċezzjoni barriera għandha dejjem tintuża ma' metodi oħra ta' kontraċezzjoni (per eżempju, kontraċettivi orali jew ormonali, ara sezzjoni 4.5) waqt terapija b'Atripla.
English: Sofosbuvir/velpatasvir and sofosbuvir/velpatasvir/voxilaprevir: Co-administration of Atripla and sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir is not recommended (see section 4.4 and Table 1)
Maltese: L-għoti fl-istess ħin ta' Atripla u sofosbuvir/velpatasvir jew sofosbuvir/velpatasvir/voxilaprevir mhuwiex rakkomandat (ara sezzjoni 4.4 u Tabella 1).
English: 300 mg/ritonavir 100 mg q.d.
Maltese: (300 mg q.d./100 mg q.d./
English: Efavirenz was not mutagenic or clastogenic in conventional genotoxicity assays.
Maltese: Efivarenz ma kienx mutaġeniku jew klastoġeniku f'analiżi konvenzjonali dwar effett tossiku fuq ilġeni.
English: In a 3-month drug interaction study, no significant differences in MPA pharmacokinetic parameters were found between subjects receiving efavirenz-containing antiretroviral therapy and subjects receiving no antiretroviral therapy.
Maltese: mediċini jew ta' affarijiet oħra fuq l-effett farmaċewtiku, ma nstabu l-ebda differenzi sinifikanti fil-parametri farmakokinetiċi ta' MPA bejn pazjenti li kienu qed jirċievu terapija antiretrovirali li fiha efavirenz u pazjenti li ma jirċievu l-ebda terapija antiretrovirali.
English: A decreased dosage of 250 mg didanosine co-administered with tenofovir disoproxil therapy has been associated with reports of high rates of virologic failure within several tested combinations.
Maltese: Doża mnaqqsa ta' 250 mg didanosine mogħtija fl-istess ħin ma' terapija b'tenofovir disoproxil ġiet assoċjata ma' rapporti ta' rati għolja ta' falliment viroloġiku f'diversi kombinazzjonijiet ittestjati.
English: Elderly patients are more likely to have decreased hepatic or renal function, therefore caution should be exercised when treating elderly patients with Atripla (see section 4.2).
Maltese: Pazjenti anzjani aktar probabbli li jkollhom tnaqqis tal-funzjoni epatika jew renali, għalhekk għandha tingħata attenzjoni partikulari meta pazjent anzjani jkunu qed jingħataw it-trattament b'Atripla (ara sezzjoni 4.2).
English: - pimozide, imipramine, amitriptyline or clomipramine (used to treat certain mental conditions) - St. John's wort (Hypericum perforatum) (a herbal preparation used for depression and anxiety) - voriconazole (used to treat fungal infections) - flecainide, metoprolol (used to treat irregular heart beat) - certain antibiotics (macrolides, fluoroquinolones, imidazole)
Maltese: - voriconazole (użati biex jittrattaw infezzjonijiet fungali) - flecainide, metoprolol (użati biex jittrattaw taħbit irregolari tal-qalb) - ċerti antibijotiċi (macrolides, fluoroquinolones, imidazole) - sustanzi antifungali triazole - ċerti sustanzi kontra l-malarja - methadone (użat biex jittratta l-vizzju tat-teħid tal-oppju)
English: Hepatobiliary disorders: Common elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT), elevated gammaglutamyltransferase (GGT)
Maltese: (AST) għolja, alanine aminotransferase
English: Side effects to the liver: If you are also infected with hepatitis B virus, you may experience a worsening of hepatitis after discontinuation of treatment (see section 3).
Maltese: Jekk int ukoll infettat bil-virus tal-epatite B, tista' tħoss li l-epatite tiegħek tmur għall-agħar wara t-twaqqif tat-trattament (ara sezzjoni 3).
English: Injection:
Maltese: Injezzjoni:
English: It is recommended that Atripla be taken on an empty stomach, preferably at bedtime.
Maltese: Huwa rrikkmandat li Atripla tittieħed fuq stonku vojt, preferibbilment fil-ħin tal-irqad.
English: Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy (CART) and should be monitored according to standard practice.
Maltese: Pazjenti b'funzjoni ħażina diġà eżistenti tal-fwied fosthom epatite kronika attiva għandhom frekwenza miżjuda ta' anormalitajiet tal-funzjoni tal-fwied waqt terapija antiretrovirali kombinata (CART) u għandhom jiġu sorveljati skont il-prattika standard.