FrancophonIA/ELRC3.0 huggingface dataset:
English: Common hypertriglyceridaemia hyperglycaemia, hypertriglyceridaemia
Maltese: Komuni ipertrigliċeridimja ipergliċemija, ipertrigliċeridimja
English: In a 144-week open-label randomised clinical study (GS-01-934) antiretroviral treatment-naïve HIV-1 infected patients received either a once-daily regimen of efavirenz, emtricitabine and tenofovir disoproxil or a fixed combination of lamivudine and zidovudine administered twice daily and efavirenz once daily (please refer to the Summary of Product Characteristics for emtricitabine/tenofovir disoproxil).
Maltese: Fi studju kliniku każwali bit-tikketta mikxufa ta' 144 ġimgħa (GS-01-934) li fih, pazjenti infettati blHIV-1 li qatt ma kienu ħadu trattament antiretrovirali qabel irċevew jew kors ta' darba kuljum ta' efavirenz, emtricitabine u tenofovir disoproxil jew kombinazzjoni fissa ta' lamivudine u zidovudine mogħti darbtejn kuljum u efavirenz darba kuljum (jekk jogħġbok irreferi għas-Sommarju talKaratteristiċi tal-Prodott għal emtricitabine/tenofovir disoproxil).
English: Reference: single dose of a 600 mg efavirenz tablet, 200 mg emtricitabine capsule and 245 mg tenofovir disoproxil tablet taken under fasted conditions.
Maltese: Referenza: doża waħda ta' pillola ta' efavirenz ta' 600 mg, kapsula ta' 200 mg emtricitabine u pillola ta' 245 mg tenofovir disoproxil meħudin f'kundizzjonijiet ta' sawm.
English: Stayed on original treatment regimen (N=97)
Maltese: Baqgħu fuq ir-reġim ta' trattament oriġinali (N=97) n/N (%)
English: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka.
Maltese: Treddax matul trattament b'Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
English: Uncommon hypersensitivity
Maltese: Komuni ħafna ipofosfatimja
English: These drugs include: antiarrhythmics of classes IA and III, neuroleptics, antidepressive agents, certain antibiotics including some agents of the following classes: macrolides, fluoroquinolones, imidazole and triazole antifungal agents, certain non-sedating antihistamines (terfenadine, astemizole), cisapride, flecainide, certain antimalarials, methadone (see sections 4.4, 4.5 and 5.1).
Maltese: Dawn il-mediċini jinkludu: antiarritmiċi tal-klassijiet IA u III, newrolettiċi, sustanzi antidepressivi, ċerti antibijotiċi li jinkludu xi sustanzi mill-klassijiet li ġejjin: macrolides, fluoroquinolones, sustanzi antifungali imidazole u triazole, ċerti antistamini mhux sedattivi (terfenadine, astemizole), cisapride, flecainide, ċerti sustanzi kontra l-malarja, methadone (ara sezzjonijiet 4.4, 4.5 u 5.1).
English: Lumefantrine: AUC: ↓ 21% Cmax: ↔
Maltese: AUC: ↓ 21% Cmax: ↔
English: Uncommon hypercholesterolaemia hypokalaemia
Maltese: Mhux komuni iperkolesterolimja ipokalimja
English: allergic reaction (hypersensitivity) that may cause severe skin reactions (Stevens-Johnson syndrome, erythema multiforme, see section 2) swelling of the face, lips, tongue or throat angry behaviour, suicidal thoughts, strange thoughts, paranoia, unable to think clearly, mood being affected, seeing or hearing things that are not really there (hallucinations), suicide attempts, personality change (psychosis), catatonia (a condition in which the patient is rendered motionless and speechless for a period) pain in the abdomen (stomach), caused by inflammation of the pancreas forgetfulness, confusion, fitting (seizures), incoherent speech, tremor (shaking) yellow skin or eyes, itching, or pain in the abdomen (stomach) caused by inflammation of the liver damage to kidney tubules
Maltese: reazzjoni allerġika (sensittività eċċessiva) li tista' tikkawża reazzjonijiet serji tal-ġilda (sindromu ta' Stevens-Johnson, eritema multiformi, ara sezzjoni 2) nefħa tal-wiċċ, ix-xufftejn, l-ilsien jew il-gerżuma imġiba rrabjata, ideat suwiċidali, ħsibijiet strambi, paranojja, ma tistax taħseb sewwa, burdata li tkun affettwata, tara jew tisma' affarijiet li ma jkunux veru hemm (alluċinazzjonijiet), attentati ta' suwiċidju, tibdil fil-personalità (psikożi), katatonja (kundizzjoni fejn il-pazjent ma jkunx jista' jiċċaqlaq jew jitkellem għal perjodu ta' żmien) uġigħ fl-addome (stonku), ikkaġunat minn infjammazzjoni tal-frixa tinsa, konfużjoni, aċċessjonijiet, diskors li ma jiftiehemx, rogħda (tertir) ġilda jew għajnejn sofor, ħakk, jew uġigħ fl-addome (stonku) ikkaġunat minn infjammazzjoni tal-fwied ħsara lit-tubuli tal-kliewi
English: Dose adjustment: If Efavirenz/Emtricitabine/Tenofovir disoproxil Krka is co-administered with rifampicin to patients weighing 50 kg or more, an additional 200 mg/day (800 mg total) of efavirenz may be considered (see section 4.5).
Maltese: Jekk Efavirenz/Emtricitabine/Tenofovir disoproxil Krka jingħata flimkien ma' rifampicin lil pazjenti li jiżnu 50 kg jew aktar, jistgħu jiġu kkunsidrati 200 mg/kuljum (total ta' 800 mg) ta' efavirenz addizzjonali (ara sezzjoni 4.5).
English: if you are currently taking any of the following medicines (see also “Other Medicines and Efavirenz/Emtricitabine/Tenofovir disoproxil Krka”): 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) - 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) - triazole antifungal agents - certain antimalarial agents - methadone (used to treat opiate addiction)
Maltese: - jekk bħalissa qed tieħu xi mediċini minn dawn li ġejjin (ara wkoll “Mediċini oħra u Efavirenz/Emtricitabine/Tenofovir disoproxil Krka”): - 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 (użat biex jittratta ċerti kundizzjonijiet mentali) - St.
English: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka in combination with darunavir/ritonavir 800/100 mg once daily may result in suboptimal darunavir Cmin.
Maltese: Efavirenz/Emtricitabine/Te nofovir disoproxil Krka flimkien ma' darunavir/ritonavir 800/100 mg darba kuljum jista' jirriżulta f'darunavir Cmin subottimali.
English: Saquinavir/ritonavir/Emtricitabine Interaction not studied.
Maltese: Saquinavir/ritonavir/Emtricitabine L-interazzjoni ma ġietx studjata.
English: This indicates that active tubular secretion is an important part of the elimination of tenofovir.
Maltese: Dan jindika li t-tnixxija tubulari attiva hija parti importanti mill-eliminazzjoni ta' tenofovir.
English: Cmin: ↑ 37%
Maltese: AUC: ↑ 22% Cmin: ↑ 37%
English: Resistance to emtricitabine or tenofovir has been seen in vitro and in some HIV-1 infected patients due to the development of an M184V or M184I substitution in RT with emtricitabine or a K65R substitution in RT with tenofovir.
Maltese: Reżistenza għal emtricitabine jew tenofovir intweriet in vitro u f'xi pazjenti infettati b'HIV-1 minħabba l-iżvilupp ta' sostituzzjoni ta' M184V jew M184I f'RT b'sostituzzjoni ta' emtricitabine jew ta' K65R f'RT b'tenofovir.
English: In in vitro studies efavirenz did not inhibit CYP2E1 and inhibited CYP2D6 and CYP1A2 only at concentrations well above those achieved clinically.
Maltese: Fi studji in vitro, efavirenz ma xekkilx CYP2E1 iżda impedixxa CYP2D6 u CYP1A2 biss f'konċentrazzjonijiet 'l fuq sewwa minn dawn miksuba klinikament.
English: Cmin: ↓ 34% (↓ 43 to ↑ 24)
Maltese: Cmin: ↓ 35% (↓ 24 għal ↓ 44)
English: The adverse reactions from clinical study and post-marketing experience with efavirenz/emtricitabine/tenofovir disoproxil and the individual components of efavirenz/emtricitabine/tenofovir disoproxil in antiretroviral combination therapy are listed in Table 2 below by body system organ class, frequency and the component(s) of efavirenz/emtricitabine/tenofovir disoproxil to which the adverse reactions are attributable.
Maltese: Ir-reazzjonijiet avversi minn studju kliniku u l-esperjenza ta' wara t-tqegħid fis-suq b'efavirenz/emtricitabine/tenofovir disoproxil u l-komponenti individwali ta' efavirenz/emtricitabine/tenofovir disoproxil f'terapija antiretrovirali kkumbinata huma elenkati f'Tabella 2 hawn taħt bis-sistema tal-klassifika tal-organi tal-ġisem, frekwenza u l-komponent(i) ta' efavirenz/emtricitabine/tenofovir disoproxil li għalihom ir-reazzjonijiet avversi huma attribwibbli.
English: The clinical outcome of this observed reduction of boceprevir trough concentrations has not been directly assessed.
Maltese: Leżitu kliniku ta' dan ittnaqqis osservat ta' talkonċentrazzjonijiet minimi ta' boceprevir ma ġewx assessjati direttament.
English: When efavirenz is coadministered 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.
Maltese: Meta efavirenz jingħata flistess ħin ma' imblokkatur tal-kanali talkalċju li jkun sottostrat ta' enzima CYP3A4, hemm potenzjal għal tnaqqis filkonċentrazzjonijiet tal-plażma talimblokkatur tal-kanali tal-kalċju.
English: Co-administration of Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka with sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/ voxilaprevir is not recommended (see section 4.4).
Maltese: Efavirenz/Emtricitabine/Te nofovir disoproxil Krka ma' sofosbuvir/velpatasvir jew sofosbuvir/velpatasvir/ voxilaprevir mhuwiex rakkomandat (ara sezzjoni 4.4).
English: The separate pharmaceutical forms of efavirenz, emtricitabine and tenofovir disoproxil were used to determine the pharmacokinetics of efavirenz, emtricitabine and tenofovir disoproxil, administered separately in HIV infected patients.
Maltese: Il-forom farmaċewtiċi separati ta' efavirenz, emtricitabine u tenofovir disoproxil intużaw biex jiġu stabbiliti l-farmakokinetiċi ta' efavirenz, emtricitabine u tenofovir disoproxil, mogħtija separatament f'pazjenti infettati b'HIV.
English: Interaction with didanosine Co-administration of Efavirenz/Emtricitabine/Tenofovir disoproxil Krka and didanosine is not recommended as it results in a 40-60% increase in systemic exposure to didanosine that may increase the risk of didanosine-related adverse reactions (see section 4.5).
Maltese: L-għoti ta' Efavirenz/Emtricitabine/Tenofovir disoproxil Krka flimkien ma' didanosine mhuwiex rakkomandat għax jista' jirriżulta f'żieda ta' 40-60% fl-esponiment sistemiku għal didanosine li jista' jżid ir-riskju ta' reazzjonijiet avversi relatati ma' didanosine (ara sezzjoni 4.5).
English: Anencephaly and unilateral anophthalmia with secondary enlargement of the tongue were observed in one foetus, microophthalmia was observed in another foetus and cleft palate was observed in a third foetus.
Maltese: Anenċefalija u anoftalmija unilaterali bi tkabbir sekondarju tal-ilsien kienu osservati f'fetu wieħed, mikroftalmija kienet osservata f'fetu ieħor, u palat mixquq kien osservat fit-tielet fetu.
English: Fosamprenavir/ritonavir/Emtricitab ine
Maltese: Fosamprenavir/ritonavir/ Emtricitabine
English: The increase in efavirenz pharmacokinetic parameters is not considered clinically significant.
Maltese: Iż-żieda fil-parametri farmakokinetiċi ta' efavirenz mhix meqjusa klinikament sinifikanti.
English: Buprenorphine/naloxone/Emtricita bine
Maltese: Buprenorphine/naloxone/ Emtricitabine
English: The inducing effect of St. John's wort may persist for at least 2 weeks after cessation of treatment (see section 4.3).
Maltese: John's wort jista' jippersisti għal mill-anqas ġimagħtejn wara t-twaqqif tat-trattament (ara sezzjoni 4.3).
English: Pharmacokinetics in special populations
Maltese: Farmakokinetika fil-popolazzjonijiet speċjali
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka 600 mg/200 mg/245 mg film-coated tablets efavirenz/emtricitabine/tenofovir disoproxil
Maltese: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka 600 mg/200 mg/245 mg pilloli miksijin b'rita efavirenz/emtricitabine/tenofovir disoproxil
English: Each film-coated tablet contains 600 mg of efavirenz, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (as succinate).
Maltese: Kull pillola miksija b'rita fiha 600 mg ta' efavirenz, 200 mg ta' emtricitabine u 245 mg ta' tenofovir disoproxil (bħala succinate).
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka is contraindicated with concomitant use of drugs that are known to prolong the QTc interval and could lead to Torsade de Pointes, such as: antiarrhythmics of classes IA and III, neuroleptics and antidepressant agents, certain antibiotics including some agents of the following classes: macrolides, fluoroquinolones, imidazole, and triazole antifungal agents, certain non-sedating antihistaminics (terfenadine, astemizole), cisapride, flecainide, certain antimalarials and methadone (see section 4.3).
Maltese: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka huwa kontraindikat mal-użu konkomitanti ta' mediċini li huma magħrufa li jtawlu l-intervall QTc u jistgħu jwasslu għal Torsade de Pointes, bħal: antiarritmiċi tal-klassijiet IA u III, newrolettiċi u sustanzi antidepressivi, ċerti antibijotiċi li jinkludu xi sustanzi tal-klassijiet li ġejjin: macrolides, fluoroquinolones, sustanzi antifungali imidazole, u triazole, ċerti antistamini mhux sedattivi (terfenadine, astemizole), cisapride, flecainide, ċerti sustanzi kontra lmalarja u methadone (ara sezzjoni 4.3).
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka 600 mg/200 mg/245 mg film-coated tablets
Maltese: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka 600 mg/200 mg/245 mg pilloli miksijin b'rita
English: Late-onset neurological disorders have been reported rarely (hypertonia, convulsion, abnormal behaviour).
Maltese: Disturbi newroloġiċi li dehru aktar tard ġew irrappurtati b'mod rari (ipertonija, aċċessjoni, mġiba anormali).
English: 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
Maltese: 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.
English: Recommendation concerning co-administration with Efavirenz/Emtricitabine/Tenof ovir disoproxil Krka (efavirenz 600 mg, emtricitabine 200 mg, tenofovir disoproxil 245 mg)
Maltese: Rakkomandazzjoni dwar l-għoti flimkien ma' Efavirenz/Emtricitabine/ Tenofovir disoproxil Krka (efavirenz 600 mg, emtricitabine 200 mg, tenofovir disoproxil 245 mg)
English: 13/19 (68%) patients in the efavirenz + emtricitabine + tenofovir disoproxil group and in virus from 21/29 (72%) patients in the efavirenz + lamivudine/zidovudine group.
Maltese: Reżistenza ġenotipika għal efavirenz, fil-biċċa l-kbira l-bidla ta' K103N, żviluppat f'virus f'13/19 (68%) tal-pazjenti fil-grupp ta' efavirenz + emtricitabine + tenofovir disoproxil u f'virus f'21/29 (72%) tal-pazjenti fil-grupp efavirenz + lamivudine/zidovudine.
English: Malformations have been observed in foetuses from efavirenz-treated monkeys (see section 5.3).
Maltese: Mankamenti ġew osservati f'feti ta' xadini kkurati b'efavirenz (ara sezzjoni 5.3).
English: On-therapy genotypes
Maltese: Ġenotipi waqt it-terapija
English: Krka
Maltese: Kft.
English: AUC: ↑ 81% (↑ 68 to ↑ 94) Cmax: ↑ 77% (↑ 53 to ↑ 104) Cmin: ↑ 121% (↑ 100 to ↑ 143)
Maltese: Cmax: ↑ 77% (↑ 53 għal ↑ 104) Cmin: ↑ 121% (↑ 100 għal ↑ 143)
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 ta' sottostrati għal dawn l-enzimi meta ngħataw flimkien ma' efavirenz in vivo.
English: In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Maltese: F'xi pazjenti b'infezzjoni talHIV avvanzata (AIDS) u bi storja ta' infezzjoni opportunistika, sinjali u sintomi ta' infjammazzjoni minn infezzjonijiet ta' qabel jistgħu jseħħu wara li jinbeda trattament kontra l-HIV.
English: dizziness headache
Maltese: Każijiet epatiċi
English: 3, dizziness (8.5%)
Maltese: 3, somnolenza 3, uġigħ ta' ras 3, disturb talattenzjoni (3.6%) sturdament (8.5%)
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' isoenzimi ta' CYP b'efavirenz.
English: Efavirenz has been shown to induce CYP3A4 and CYP2B6, resulting in the induction of its own metabolism, which may be clinically relevant in some patients.
Maltese: Efavirenz intwera li jinduċi CYP3A4 u CYP2B6, li jirriżulta fl-induzzjoni tal-metaboliżmu tiegħu stess, li jista' jkun klinikament rilevanti għal xi pazjenti.
English: Tenofovir disoproxil and emtricitabine, two of the active substances in Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, show some activity against hepatitis B virus although emtricitabine is not approved for the treatment of hepatitis B infection.
Maltese: Tenofovir disoproxil u emtricitabine, tnejn mis-sustanzi attivi f'Efavirenz/Emtricitabine/Tenofovir disoproxil Krka juru xi attività kontra l-virus talepatite B għalkemm emtricitabine mhuwiex approvat għat-trattament tal-infezzjoni blepatite B.
English: Cmax: ↓ 37% (↓ 20 to ↓ 51) Cmin: ↓ 44% (↓ 27 to ↓ 58) (decrease in itraconazole concentrations: CYP3A4 induction)
Maltese: ↓ 39% (↓ 21 għal ↓ 53) Cmax: ↓ 37% (↓ 20 għal ↓ 51) Cmin: ↓ 44% (↓ 27 għal ↓ 58) (tnaqqis fil-konċentrazzjonijiet ta' itraconazole: induzzjoni ta' CYP3A4)
English: Following intravenous administration the volume of distribution of tenofovir was approximately 800 ml/kg.
Maltese: Wara għoti ġol-vini, ilvolum ta' distribuzzjoni ta' tenofovir kien madwar 800 ml/kg.
English: if you have a heart condition, such as an abnormal electrical signal called prolongation of the QT interval that puts you at high risk for severe heart rhythm problems (Torsade de Pointes).
Maltese: - jekk għandek kundizzjoni tal-qalb, bħal sinjal elettriku anormali msejjaħ titwil talintervall QT li jqiegħdek f'riskju għoli ta' problemi severi fir-ritmu tal-qalb (Torsade de Pointes).
English: Efavirenz, one of the active components of Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, may remain in your blood for a time after therapy is stopped.
Maltese: Efavirenz, wieħed mill-komponenti attivi ta' Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, jista' jibqa' f'demmek għal xi żmien wara li titwaqqaf it-terapija.
English: Lopinavir/ritonavir tablets/Efavirenz (400/100 mg b.i.d./600 mg q.d.)
Maltese: Lopinavir/ritonavir pilloli/Efavirenz (400/100 mg b.i.d./600 mg q.d.)
English: The adverse reaction profile of efavirenz, emtricitabine and tenofovir disoproxil in patients co-infected with HIV/HBV or HIV/HCV was similar to that observed in patients infected with HIV without co-infection.
Maltese: Il-profil tar-reazzjonijiet avversi ta' efavirenz, emtricitabine u tenofovir disoproxil f'pazjenti ko-infettati b'HIV/HBV jew b'HIV/HCV kien jixbah lil dak osservat f'pazjenti infettati blHIV mingħajr ko-infezzjoni.
English: Table 1: Interactions between efavirenz/emtricitabine/tenofovir disoproxil or its individual components and other medicinal products
Maltese: Tabella 1: Interazzjonijiet bejn Efavirenz/Emtricitabine/Tenofovir disoproxil Krka jew ilkomponenti individwali tiegħu u prodotti mediċinali oħra
English: When the two strata were analysed separately, response rates in the stratum with prior PI-treatment were numerically lower for patients switched to efavirenz/emtricitabine/tenofovir disoproxil [92.4% versus 94.0% for the PVR (sensitivity analysis) for efavirenz/emtricitabine/tenofovir disoproxil and SBR patients respectively; a difference (95%CI) of -1.6% (-10.0%, 6.7%).
Maltese: Meta ż-żewġ strata kienu analizzati separatament, ir-rati tar-rispons fl-istratum b'kura bil-PI fil-passat kienu numerikament iktar baxxi għal pazjenti li qalbu għal efavirenz/emtricitabine/tenofovir disoproxil [92.4% kontra 94.0% għall-PVR (analiżi tas-sensittività) għal efavirenz/emtricitabine/tenofovir disoproxil u pazjenti SBR (stayed on their baseline regimen) rispettivament; differenza (95%CI) ta' -1.6% (-10.0%, 6.7%)].
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka is contraindicated in patients with severe hepatic impairment (see section 4.3) and not recommended in patients with moderate hepatic impairment.
Maltese: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka huwa kontra-indikat f'pazjenti b'indeboliment epatiku sever (ara sezzjoni 4.3) u mhux rakkomandat għal pazjenti b'indeboliment epatiku moderat.
English: Because of the limited information available, a reliable method of barrier contraception must be used in addition to hormonal contraceptives (see section 4.6).
Maltese: Minħabba l-informazzjoni limitata disponibbli, għandu jintuża metodu affidabbli ta' kontraċezzjoni tat-tip barriera flimkien malkontraċettivi ormonali (ara sezzjoni 4.6).
English: Atazanavir/ritonavir/Emtricitabine Interaction not studied.
Maltese: Atazanavir/ritonavir/Emtricitabine L-interazzjoni ma ġietx studjata.
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka 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: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka ma għandux 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 talmetaboliżmu tagħhom tista' twassal għal episodji ta' perikli serji għas-saħħa (ara sezzjoni 4.3).
English: - if you are taking other medicines that contain efavirenz, emtricitabine, tenofovir disoproxil, tenofovir alafenamide, or lamivudine or adefovir dipivoxil.
Maltese: - jekk qed tieħu mediċini oħra li fihom efavirenz, emtricitabine, tenofovir disoproxil, tenofovir alafenamide, lamivudine jew adefovir dipivoxil.
English: 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 efavirenzcontaining fixed-dose combination tablets) in the first trimester.
Maltese: Kien hemm seba' rapporti retrospettivi ta' riżultati konsistenti ma' difetti fit-tubi tan-nervituri, inkluż meningomijelosil, kollha f'ommijiet esposti għal korsijiet li kien fihom efavirenz (eskluż kwalunkwe pillola ta' kombinazzjoni ta' doża fissa li fiha efavirenz) fl-ewwel trimestru.