FrancophonIA/ELRC3.0 huggingface dataset:
English: The numerator 793 is the number of patients who were treatment responders at 48 weeks (384 from immediate-release and 409 from prolonged-release treatment groups).
Maltese: In-numeratur 793 hu n-numru ta' pazjenti li rrispondew għall-kura wara 48 ġimgħa (384 minn gruppi ta' kura li kienu qed jieħdu mediċina li terħi fil-pront u 409 li kienu qed jieħdu mediċina li terħi bil-mod).
English: The incidence of symptomatic hepatic events during the Viramune immediate-release lead-in phase was 0.5 %.
Maltese: L-inċidenza ta' avvenimenti epatiċi sintomatiċi matul il-perjodu ta' introduzzjoni b'Viramune li jerħi l-mediċina filpront kienet ta' 0.5%.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/055/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/97/055/002
English: Patients have experienced oedema, erythema nodosum, fatigue, fever, headache, insomnia, nausea, pulmonary infiltrates, rash, vertigo, vomiting, increase in transaminases and weight decrease.
Maltese: Ilpazjenti qabadhom edema, eritema nodosum, għeja, deni, uġigħ ta' ras, nuqqas ta' rqad, dardir, infiltrament ġol-pulmuni, raxx, mejt, rimettar, żjieda fl-enzimi transaminases, u tnaqqis fil-piż korporali.
English: 3 for the groups receiving Viramune immediate-release and Viramune prolonged-release respectively.
Maltese: 3 fil-gruppi ta' Viramune li jittieħed darbtejn kuljum u efavirenz, rispettivament.
English: Saquinavir/ritonavir The limited data available with saquinavir soft gel capsule boosted with ritonavir do not suggest any clinically relevant interaction between saquinavir boosted with ritonavir and nevirapine
Maltese: Id-data limitata disponibbli b'kapsula ta' ġell artab ta' saquinavir imsaħħaħ b'ritonavir ma tindika l-ebda interazzjoni klinikament rilevanti bejn saquinavir imsaħħaħ b'ritonavir u nevirapine
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/055/007
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/97/055/007
English: Thus cytochrome P450 metabolism, glucuronide conjugation, and urinary excretion of glucuronidated metabolites represent the primary route of nevirapine biotransformation and elimination in humans.
Maltese: Għaldaqstant il-metaboliżmu ta' ċitokroma P450, konġugazzjoni mal-glucuronide, u eliminazzjoni fl-awrina ta' dawn il-metaboliti ikkonġugati mal-glucuronide huma r-rotot ewlenin ta' kif nevirapine jiġi mibdul fil-ġisem tal-bniedem u jiġi eliminat.
English: The most frequently reported adverse reactions related to Viramune prolonged-release therapy in treatment naïve patients (including lead-in phase with immediate-release) in clinical study 1100.1486 (VERxVE) were rash, nausea, liver function test abnormal, headache, fatigue, hepatitis, abdominal pain, diarrhoea and pyrexia.
Maltese: 1486 (VERxVE) kienu raxx, nawseja, testijiet abnormali tal-funzjonament tal-fwied, uġigħ ta' ras, għeja, epatite, uġigħ addominali, dijarea u deni.
English: Women have a three fold higher risk than men for symptomatic, often rash-associated, hepatic events (5.8 % versus 2.2 %), and treatment-naïve patients of either gender with detectable HIV-1 RNA in plasma with higher CD4 counts at initiation of nevirapine therapy are at higher risk for symptomatic hepatic events with nevirapine.
Maltese: In-nisa għandhom riskju tliet darbiet ogħla mill-irġiel li jiżviluppaw problemi sintomatiċi fil-fwied, u ta' spiss assoċjati ma raxx (5.8% kontra 2.2%) u pazjenti li qatt ma rċivew kura fil-passat taż-żewġ sessi li jkollhom HIV-1 RNA li jista' jiġi osservat fil-plażma b'għadd akbar ta' CD4 mal-bidu tat-terapija b'nevirapine huma f'riskju ogħla ta' każijiet sintomatiċi epatiċi b'nevirapine.
English: Viramune immediate-release
Maltese: Twissijiet u prekawzjonijiet
English: Granulocytopenia was more frequently observed in children.
Maltese: Granuloċitopenija kienet osservata aktar frekwentament fit-tfal.
English: Ketoconazole and erythromycin significantly inhibited the formation of nevirapine hydroxylated metabolites.
Maltese: Barraminhekk, il-konċentrazzjonijiet minimi ta' nevirapine osservati kienu komparabbli fiż-żewġ metodi.
English: Polyvinyl chloride (PVC)/aluminium foil push through blister units.
Maltese: Unitajiet tad-doża tal-polyvinyl chloride (PVC)/fojl tal-aluminju li tista' timbuttah.
English: Compounds using this metabolic pathway may have decreased plasma concentrations when coadministered with nevirapine.
Maltese: Kien hemm ukoll akkumulazzjoni ta' metaboliti idrossilatati ta' nevirapine fil-plażma.
English: However, approximately 15 % of these patients with hepatic fibrosis had nevirapine trough concentrations above 9,000 ng/ml (2 fold the usual mean trough).
Maltese: Kien hemm biss ammont zgħir (< 5 %) ta' nevirapine (mhux mibdul) radjutikkettat fl-awrina (< 3% tad-doża totali).
English: Viramune 400 mg prolonged-release tablets are supplied in blisters, with 30 or 90 prolonged-release tablets per carton.
Maltese: Il-pilloli Viramune 400 mg li jerħu l-mediċina bil-mod jiġu f'folji, bi 30 jew 90 pillola li jerħu l-mediċina bil-mod f'kull kartuna.
English: White, oval, biconvex tablets.
Maltese: Ħu l-pilloli Viramune mill-ħalq biss.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/055/004
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/97/055/004
English: Rapid emergence of HIV-strains which are cross-resistant to NNRTIs has been observed in vitro.
Maltese: Ġiet osservata reżistenza inkroċjata ta' razez ta' HIV li tfaċċat malajr għal NNRTIs in vitro.
English: The nevirapine postmarketing experience has shown that the most serious adverse reactions are Stevens-Johnson syndrome/toxic epidermal necrolysis, serious hepatitis/hepatic failure, and drug reaction with eosinophilia and systemic symptoms, characterised by rash with constitutional symptoms such as fever, arthralgia, myalgia and lymphadenopathy, plus visceral involvement, such as hepatitis, eosinophilia, granulocytopenia, and renal dysfunction.
Maltese: L-esperjenza ta' wara li l-prodott tqiegħed fis-suq ta' nevirapine wriet li l-aktar effetti mhux mixtieqa serji huma: is sindromu ta' Stevens-Johnson/nekroliżi tossika epidermali, epatite serja/ insuffiċjenza tal-fwied, u reazzjoni minħabba l-mediċina b'eosinofilija u sintomi sistemiċi li huma kkaratterizzati b'raxx u sintomi avversi fil-ġisem bħad deni, artalaġja, uġigħ fil-muskoli, u limfodenopatija, kif ukoll problemi vixxerali bħal epatite, eosinofilja, granuloċitopenija u disfunzjoni renali.
English: Weight Range (kg) for patients < 8 yrs of age
Maltese: Medda ta' Piż (kg ) għal pazjenti ta'  8 snin
English: Viramune may be dosed in paediatric patients either by body surface area (BSA) or by body weight as follows: By BSA using the Mosteller formula the recommended oral dose for paediatric patients of all ages is 150 mg/m2 once daily for two weeks followed by 150 mg/m2 twice daily thereafter.
Maltese: Skont BSA bl-użu tal-formula ta' Mosteller, id-doża orali rakkomandata għal pazjenti pedjatriċi taletajiet kollha hi ta' 150 mg/m2 darba kuljum għal ġimagħtejn segwita minn 150 mg/m2 darbtejn kuljum wara dak il-perjodu.
English: Due to the metabolic pathway of entecavir, no clinically relevant drug-drug interaction is expected.
Maltese: Minħabba lpassaġġ metaboliku ta' entecavir, lebda interazzjoni klinikament rilevanti bejn mediċina u oħra mhi mistennija.
English: Boehringer Ingelheim Ellas A.E. Tηλ: +30 2 10 89 06 300
Maltese: Boehringer Ingelheim Sp. z o.o. Tel.: +48 22 699 0 699
English: However the risk continues past this period and monitoring should continue at frequent intervals throughout treatment.
Maltese: Madankollu r-riskju jissokta wara dan il-perijodu u l-monitoraġġ għandu jibqa' fuq frekwenza spissa waqt it-trattament.
English: In study 1100.1486 (VERxVE) antiretroviral-naïve patients received a lead-in dose of Viramune 200 mg immediate-release once daily for 14 days (n=1068) and then were randomised to receive either Viramune 200 mg immediate-release twice daily or Viramune 400 mg prolonged-release once daily.
Maltese: 1486 (VERxVE) pazjenti li qatt ma rċivew kura antiretrovirali fil-passat, irċivew doża ta' introduzzjoni ta' Viramune 200 mg li jerħi l-mediċina fil-pront darba kuljum għal 14-il jum (n=1,068), u mbagħad intgħażlu b'mod każwali biex jirċievu jew Viramune 200 mg li jerħi l-mediċina fil-pront darbtejn kuljum jew Viramune 400 mg li jerħi l-mediċina bil-mod darba kuljum.
English: The active substance of your medicine is called nevirapine.
Maltese: Is-sustanza attiva tal-mediċina tiegħek tissejjaħ nevirapine.
English: If you have a renal or hepatic dysfunction of any degree please use only Viramune 200 mg tablets or Viramune 50 mg/5 ml oral suspension.
Maltese: Jekk għandek disfunzjoni tal-kliewi jew tal-fwied ta' kwaunkwe grad, jekk jogħġbok uża biss il-pilloli Viramune 200 mg jew Viramune 50 mg/5 ml suspensjoni orali.
English: 3 had a 12 fold higher risk of symptomatic hepatic adverse reactions compared to women with CD4 counts <250 cells/mm
Maltese: 3 kellhom riskju 12-il darba akbar li jkollhom reazzjonijiet sintomatiċi epatiċi avversi meta mqabbla ma' nisa b'livelli ta' ċelluli CD4 <250 ċelluli/mm
English: It is very important that you take only 20 ml of Viramune a day for the first 14 days (“lead-in” period).
Maltese: Huwa importanti ħafna li tieħu biss 20 ml ta' Viramune kuljum fl-ewwel 14-il jum (il-perijodu “inizjali”).
English: Clear polypropylene 5 ml dispensing syringe with silicone rubber piston seal.
Maltese: Siringa ċara magħmula minn polypropylene ta' 5 ml b'siġill ta' parti ta' wara magħmul minn lastiku tas-silicone.
English: Patients who are already on immediate-release tablets or oral suspension can switch to prolongedrelease tablets without lead-in period.
Maltese: Viramune jiġi wkoll bħala suspensjoni orali, pilloli jew bħala pillola li jerħu l-mediċina bil-mod inqas qawwija.
English: Viramune immediate-release n=506
Maltese: Tibdil perċent wali n=406
English: - St. John's Wort (Hypericum perforatum, medicine to treat depression) - rifampicin (medicine to treat tuberculosis) - rifabutin (medicine to treat tuberculosis) - macrolides e.g. clarithromycin (medicine to treat bacterial infections) - fluconazole (medicine to treat fungal infections) - ketoconazole (medicine to treat fungal infections) - itraconazole (medicine to treat fungal infections) - methadone (medicine used for treatment of opiate addicts) - warfarin (medicine to reduce blood clotting) - hormonal contraceptives (e.g. the “pill”) - atazanavir (another medicine to treat HIV-infection) - lopinavir/ritonavir (another medicine to treat HIV-infection) - fosamprenavir (another medicine to treat HIV-infection) - efavirenz (another medicine to treat HIV-infection) - etravirine (another medicine to treat HIV-infection) - rilpivirine (another medicine to treat HIV-infection) - delavirdine (another medicine to treat HIV-infection) - zidovudine (another medicine to treat HIV-infection) - boceprevir (medicine to treat hepatitis C) - telaprevir (medicine to treat hepatitis C) - elvitegravir/cobicistat (another medicine to treat HIV-infection)
Maltese: John's Wort (Hypericum perforatum, mediċina li tikkura d-dipressjoni) - rifampicin (mediċina li tikkura t-tuberkolosi) - rifabutin (mediċina li tikkura t-tuberkolosi) - makrolidi (eż. clarithromycin) (mediċina li tikkura l-infezzjonijiet batteriċi) - fluconazole (mediċina kontra l-infezzjonijiet fungali) - ketoconazole (mediċina li tikkura l-infezzjonijiet fungali) - itraconazole (mediċina li tikkura l-infezzjonijiet fungali) - methadone (mediċina użata biex tikkura 'l persuni viżjati bil-loppji) - warfarin (mediċina li tnaqqas il-formazzjoni ta' emboli tad-demm) - kontraċettivi ormonali (eż. il-“pill”) - atazanavir (mediċina oħra li tikkura l-infezzjonijiet tal-HIV) - lopinavir/ritonavir (mediċina oħra li tikkura l-infezzjonijiet tal-HIV) - fosamprenavir (mediċina oħra li tikkura l-infezzjonijiet tal-HIV) - efavirenz (mediċina oħra li tikkura l-infezzjonijiet tal-HIV) - etravirine (mediċina oħra li tikkura l-infezzjonijiet tal-HIV) - rilpivirine (mediċina oħra li tikkura l-infezzjonijiet tal-HIV) - delavirdine (mediċina oħra li tikkura l-infezzjonijiet tal-HIV) - zidovudine (mediċina oħra għall-kura ta' infezzjoni bl-HIV) - boceprevir (mediċina li tikkura l-epatite Ċ) - telaprevir (mediċina li tikkura l-epatite Ċ) - elvitegravir/cobicistat (mediċina oħra li tikkura infezzjoni bl-HIV)
English: ANALGESICS/OPIOIDS Methadone Individual Patient Dosing
Maltese: ANALĠESIĊI/OPJOJDI Dożi Individwali ta' Methadone lil Pazjenti
English: Biotransformation and elimination: In vivo studies in humans and in vitro studies with human liver microsomes have shown that nevirapine is extensively biotransformed via cytochrome P450 (oxidative) metabolism to several hydroxylated metabolites.
Maltese: Studji fil-bniedem in vitro kif ukoll fil-laboratorju fuq mikrożomi tal-fwied tal-bniedem urew li nevirapine jiġi mibdul f'diversi metaboliti idrossilatati, permezz tas-sistema P450.
English: In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Maltese: F'pazjenti infettati b'HIV li għandhom defiċjenza immunitarja serja fiż-żmien li tinbeda t-terapija antiretrovirali kombinata (CART), jista' jkun hemm reazzjoni infjammatorja għal infezzjonijiet asintomatiċi jew opportunistiċi residwali.
English: Cases of overdose with Viramune immediaterelease at doses ranging from 800 to 6,000 mg per day for up to 15 days have been reported.
Maltese: Kien hemm każijiet irrapportati ta' pazjenti li ħadu doża eċċessiva ta' Viramune minn 800 sa 6000 mg kuljum għal 15-il jum.
English: This is especially important within the first 14 days of treatment (see more information in “How to take Viramune”).
Maltese: Dan hu importanti speċjalment fl-ewwel 14-il jum ta' kura (ara aktar informazzjoni f' “Kif għandek tieħu Viramune”).
English: Viramune prolonged-release tablets contain lactose (milk sugar).
Maltese: Il-pilloli Viramune fihom lactose (zokkor tal-ħalib).
English: Results of DDI studies of telaprevir with efavirenz indicate that caution should be exercised when co-administering telaprevir with P450 inducers.
Maltese: DDI ta' telaprevir ma' efavirenz jindikaw li għandu jkun hemm kawtela meta telaprevir jingħata flimkien ma' indutturi ta' P450.
English: Liver disease
Maltese: Riżultati kliniċi
English: - treatment-naïve patients with higher CD4 cell counts at the start of Viramune therapy (women more than 250 cells/mm³, men more than 400 cells/mm³) - pre-treated patients with detectable HIV-1 plasma viral load and higher CD4 cell counts at the start of Viramune therapy (women more than 250 cells/mm³, men more than 400 cells/mm³)
Maltese: - pazjenti li qatt ma rċivew kura fil-passat b'għadd ogħla ta' ċelloli CD4 fil-bidu tat-terapija b'Viramune (nisa aktar minn 250 ċellola/mm³, irġiel aktar minn 400 ċellola/mm³) - pazjenti kkurati fil-passat li jkollhom ammont virali ta' HIV-1 fil-plażma u għadd ta' ċelluli CD4 ogħla fil-bidu tat-terapija b'Viramune (nisa: aktar minn 250 ċellula/mm³, irġiel: aktar minn 400 ċellula/mm³)
English: The lead-in period is not required if the patient is already on chronic Viramune 200 mg tablets or Viramune oral suspension twice daily treatment.
Maltese: Dan ilperjodu ta' introduzzjoni mhuwiex meħtieġ jekk il-pazjent ikun diġà fuq kura kronika b'Viramune 200 mg pilloli jew Viramune suspensjoni orali darbtejn kuljum.
English: There were no significant differences in demographic and baseline characteristics between the treatment groups.
Maltese: Ma kienx hemm differenzi sinifikanti fil-karatteristiċi demografiċi u tallinja bażi bejn iż-żewġ gruppi ta' kura.
English: Blood and lymphatic system disorders Common granulocytopenia Uncommon anaemia Immune system disorders Common hypersensitivity (incl.
Maltese: Disturbi fis-sistema immuni Komuni sensittività eċċessiva (li tinkludi reazzjoni anafilattika, anġjoedema, urtikarja)
English: - blistering - mouth sores - inflammation of the eye - swelling of the face - general swelling - shortness of breath - muscle or joint pain - general feelings of illness - abdominal pain - hypersensitivity (allergic) reactions - inflammation of the liver (hepatitis) - if you have severe liver disease - if you have had to stop Viramune treatment in the past because of changes in your liver function - if you are taking a medicine containing the herbal substance St. John's Wort (Hypericum perforatum).
Maltese: - qtugħ ta' nifs - uġigħ muskolari jew tal-ġogi - tħoss li ma' tiflaħx b'mod ġenerali - uġigħ addominali - reazzjonijiet ta' sensittività eċċessiva (allerġija) - infjammazzjoni tal-fwied (epatite) - jekk għandek marda fil-fwied severa - jekk kellek twaqqaf it-trattament b'Viramune fil-passat minħabba bidliet fil-funzjoni tal-fwied tiegħek - jekk qed tieħu mediċina li fiha s-sustanza mill-ħxejjex ta' St.John's Wort (Hypericum perforatum).
English: Combination therapy with nevirapine is not a curative treatment of patients infected with HIV-1; patients may continue to experience illnesses associated with advanced HIV-1 infection, including opportunistic infections.
Maltese: Terapija kkombinata li fiha nevirapine mhix trattament kurattiv fuq pazjenti infettati b'HIV-1; ilpazjenti jistgħu jkomplu jimirdu b'infezzjoni avvanzata ta' HIV-1, kif ukoll b'infezzjonijiet opportunistiċi.
English: Percent change n=419
Maltese: Tibdil perċent wali n=419
English: Patients experiencing rash during the 14-day lead-in period of 200 mg/day (4 mg/kg/day or 150 mg/m2/day for paediatric patients) should not have their Viramune dose increased until the rash has resolved.
Maltese: Dawn jinkludu meta d-dożaġġ inizjali ta' 200 mg kuljum (4 mg/kg jew 150 mg/m2 għall-pazjenti pedjatriċi) waqt l-ewwel perijodu tat-trattament ma jitkompliex, kif ukoll meta jkun hemm dewmien twil meta jiżvillupaw lewwel sintomi u jkun hemm konsulta medika.
English: The pharmacokinetics of autoinduction is characterized by an approximately 1.5 to 2 fold increase in the apparent oral clearance of nevirapine as treatment continues from a single dose to two-to-four weeks of dosing with 200-400 mg/day.
Maltese: Dan l-effett jikkaġuna farmakokinetiċi karaterizzat b'żieda ta' minn madwar 1.5 darbiet sa 2 fir-rata ta' eliminazzjoni tad-doża orali ta' nevirapine hekk kif waqt it-trattament jissokta minn doża waħda ta' 200-400 mg/jum għal ġimagħtejn - erba ġimgħat.
English: Atazanavir/r AUC  0.58 (0.48-0.71) Atazanavir/r Cmin  0.28 (0.20-0.40) Atazanavir/r Cmax  0.72 (0.60-0.86)
Maltese: 48-0.71) Atazanavir/r Cmin  0.28 (0.20-0.
English: Due to the metabolic pathway of telbivudine, no clinically relevant drug-drug interaction is expected.
Maltese: Minħabba l-passaġġ metaboliku ta' telbivudine, l-ebda interazzjoni klinikament rilevanti bejn mediċina u oħra mhi mistennija.
English: Table 2: Maintenance phase of Viramune prolonged-release
Maltese: Tabella 1: Karatteristiċi Demografiċi u Karatteristiċi tal-Marda fil-Linja Bażi fi studju
English: Nevirapinemust not be restarted following severe hepatic, skin or hypersensitivity reactions (see section 4.3).
Maltese: Nevirapine m'għandux jinbeda mill-ġdid wara reazzjonijiet epatiċi u tal-ġilda serji jew reazzjonijiet ta' sensittività eċċessiva (ara sezzjoni 4.3).
English: Female patients showed a 13.8 % lower clearance of nevirapine than did male patients.
Maltese: Il-pazjenti nisa wrew rata ta' eliminazzjoni ta' nevirapine ta' 13.8% inqas mill-irġiel.
English: Caution should be exercised when prescribing nevirapine to pregnant women (see section 4.4).
Maltese: Nevirapine għandu jiġi preskritt b'kawtela lin-nisa tqal (ara sezzjoni 4.4).
English: Uncommon (may affect up to 1 in 100 people): - allergic reactions (hypersensitivity) - allergic reaction characterized by rash, swelling of the face, difficulty breathing (bronchial spasm) or anaphylactic shock - drug reaction with systemic symptoms (drug reaction with eosinophilia and systemic symptoms) - sudden and intense inflammation of the liver (fulminant hepatitis) - severe and life-threatening skin rashes (Stevens Johnson Syndrome/toxic epidermal necrolysis) - yellow skin (jaundice) - hives (urticaria) - fluid under the skin (angioneurotic oedema)
Maltese: (spażmi tal-bronki) jew xokk anafilattiku - reazzjoni minħabba l-mediċina b'sintomi sistemiċi (reazzjoni minħabba l-mediċina b'eosinofilija u sintomi sistemiċi) - infjammazzjoni f'daqqa u intensa tal-fwied (epatite fulminanti) - raxx sever tal-ġilda u ta' theddida għall-ħajja (Sindrome ta' Stevens Johnson/nekrolisi epidermali tossika) - ġilda safranija (suffejra)
English: A clinically not relevant increase in the apparent clearance of nevirapine (by 9%) compared to historical data was reported.
Maltese: Ġie rrappurtat li kien hemm żjeda mhix klinikament rilevanti fittneħħija apparenti ta' nevirapine (b'9%) meta mqabbel ma' data storika
English: Nevirapine must be permanently discontinued in any patient experiencing severe rash or a rash accompanied by constitutional symptoms (such as fever, blistering, oral lesions, conjunctivitis, facial oedema, muscle or joint aches, or general malaise), including Stevens-Johnson syndrome, or toxic epidermal necrolysis.
Maltese: Nevirapine għandu jiġi mwaqqaf b'mod permanenti kemm-il darba l-pazjenti jsofru minn raxx qawwi jew raxx flimkien ma' sintomi oħrajn fil-ġisem (bħalma huma deni, infafet, leżjonijiet fil-ħalq, konġjuntivite, edema fil-wiċċ, uġigħ fil-muskoli jew ġogi, jew telqa fil-ġisem kollu), li jinkludu wkoll is-sindrome Stevens-Johnson, jew nekroliżi epidermali tossika.
English: This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħielsa mis-sodium'.
English: In a retrospective review of predominantly patients with a plasma HIV-1 viral load of 50 copies/ml or higher, women with CD4 counts >250 cells/mm
Maltese: Minn analiżi retrospettiva ta' pazjenti fil-biċċa l-kbira tagħhom b'ammont virali ta' HIV-1 fil-plażma ta' 50 kopja/ml jew ogħla, nisa b'għadd ta' ċelluli CD4 >250 ċelluli/mm
English: The primary endpoint, treatment failure, was defined as less than 1 log10 decline in plasma HIV-1 RNA in the first 12 weeks, or two consecutive measurements of more than 50 copies/ ml from week 24 onwards, or disease progression.
Maltese: Il-punt ta' riferiment primarju, falliment tal-kura, kien imfisser bħala inqas minn tnaqqis ta' 1 log10 fl-RNA ta' HIV-1 fil-plażma fl-ewwel 12-il ġimgħa, jew kejl ripetut għal darbtejn wara xulxin ta' aktar minn 50 kopja/ml minn ġimgħa 24 'il quddiem, jew progressjoni tal-marda.
English: 3, who have a detectable plasma HIV-1 RNA unless the benefit outweighs the risk.
Maltese: 3, li jkollhom HIV-1 RNA li tkun tista' tiġi osservata fil-plażma, ħlief jekk ilbenefiċċju jkun jiżboq ir-riskju.
English: Virologic failure - Never suppressed through week 48 - Rebound
Maltese: Kollass viroloġiku - Qatt imrażżan sa ġimgħa 48
English: If clinical hepatitis occurs, characterised by anorexia, nausea, vomiting, icterus AND laboratory findings (such as moderate or severe liver function test abnormalities (excluding GGT)), nevirapine must be permanently stopped.
Maltese: Jekk tiżviluppa epatite klinika li tkun ikkaratterizzata minn anoreksja, tqallih, rimettar, icterus FLIMKIEN MA' riżultati fil-laboratorju (bħal abnormalità moderata jew qawwija fil-funzjoni tal-fwied, eskluż il-GGT)), nevirapine għandu jitwaqqaf għal dejjem.
English: Co-administration of boceprevir with medicines that induce or inhibit CYP3A4/5 could increase or decrease exposure.
Maltese: L-għoti ta' boceprevir flimkien ma' mediċini li jinduċu jew jinibixxu CYP3A4/5 jista' jżid jew inaqqas l-esponiment.