FrancophonIA/ELRC3.0 huggingface dataset:
English: In study 1100.1090, from which the majority of related adverse events (n=28) were received, patients on placebo had a higher incidence of events of granulocytopenia (3.3%) than patients on nevirapine
Maltese: 1090, li minnu ġew riċevuti l-maġġoranza ta' avvenimenti avversi (n=28), il-pazjenti fuq il-plaċebo kellhom inċidenza ogħla ta' avvenimenti ta' granuloċitopenija (3.3%) milli minn pazjenti fuq nevirapine (2.5%).
English: The ingested dose was 40 times the recommended dose of 2 mg/kg/day.
Maltese: Iddoża meħuda kienet 40 darba d-doża rakkomandata ta' 2 mg/kg/jum.
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: Atazanavir/r Cmin ↓ 0.28 (0.20-0.40) Atazanavir/r Cmax ↓ 0.72 (0.60-0.86)
Maltese: Atazanavir/r 400/100mg Atazanavir/r AUC ↓ 0.81 (0.65-1.02) Atazanavir/r Cmin ↓ 0.41 (0.27-0.60)
English: anaphylactic reaction, angioedema, urticaria) Uncommon anaphylactic reaction Rare drug reaction with eosinophilia and systemic symptoms Nervous system disorders
Maltese: - reazzjoni minħabba l-mediċina b'sintomi sistemiċi (reazzjoni minħabba l-mediċina b'eosinofilija u sintomi sistemiċi)
English: Cmin ↔ 0 (0.68-1.49)
Maltese: Cmin ↔ 0 (0.68-1.49) għal metabolit
English: Nevirapine must be permanently discontinued in any patient experiencing hypersensitivity reaction (characterised by rash with constitutional symptoms, plus visceral involvement, such as hepatitis, eosinophilia, granulocytopenia, and renal dysfunction), see section 4.4.
Maltese: Nevirapine għandu jitwaqqaf b'mod permanenti f'kull pazjent li jiżviluppa reazzjoni ta' sensittività eċċessiva (karatterizzata b'raxx u sintomi oħrajn fil-ġisem, problemi tal-vixxri, bħal epatite, eosinofilja, granuloċitopenija, u disfunzjoni renali), ara sezzjoni 4.4.
English: Mild isolated neutropenia and hyperlactataemia was observed, which spontaneously disappeared within one week without any clinical complications.
Maltese: Newtropenija iżolata u ħafifa u iperlattatemija kienet osservata, li spontanjament sparixxiet fi żmien ġimgħa mingħajr kumplikazzjonijiet kliniċi.
English: A marked improvement in the CD4+ cell percent was observed through Week 48 for both dose groups.
Maltese: Titjib notevoli fil-perċentwali ta' CD4 kien osservatgħal Ġimgħa 48 għażżewġ gruppi ddożati.
English: Each tablet contains 200 mg nevirapine (as nevirapine anhydrate).
Maltese: Kull pillola fiha 200 mg ta' nevirapine (bħala anidru).
English: No clinically relevant drug-drug interaction is expected.
Maltese: ebda interazzjoni klinikament rilevanti bejn mediċina u oħra mhi mistennija.
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, żieda fl-enzimi transaminases, u tnaqqis fil-piż tal ġisem.
English: Maraviroc Cmin ND Maraviroc Cmax ↔ 1.54 (0.94-2.52) compared to historical controls
Maltese: Maraviroc AUC ↔ 1.01 (0.6 -1.55) Maraviroc Cmin ND Maraviroc Cmax ↔ 1.54 (0.94-2.52)
English: Peak plasma nevirapine concentrations of 2 ± 0.4 μg/ml (7.5 μM) were attained by 4 hours following a single 200 mg dose.
Maltese: L-ogħla konċentrazzjoni fil-plażma ta' nevirapine kienet ta' 2 ± 0.4 µg/ml (7.5 µM) u li ntlaħqet f'4 sigħat wara li ngħatat doża waħda ta' 200 mg.
English: Nevirapine Cmin ↑ 1.22 (1.10-1.35) Nevirapine Cmax ↑ 1.13 (1.03-1.24)
Maltese: Nevirapine AUC ↑ 1.14 (1.05-1.24) Nevirapine Cmin ↑ 1.22 (1.10-1.35) Nevirapine Cmax ↑ 1.13 (1.03-1.24)
English: Female gender and higher CD4 counts (>250/mm in adult females and >400/mm in adult males) at the initiation of nevirapine therapy are associated with a greater risk of hepatic adverse reactions if the patient has detectable plasma HIV-1 RNA - i.e. a concentration ≥ 50 copies/ml - at the initiation of nevirapine.
Maltese: Nisa u pazjenti li għandhom il-livelli ta' ċelluli CD4+ ogħla (>250/mm f'adulti nisa u and >400/mm f'adulti rġiel) fil-bidu ta' terapija ta' nevirapine huma assoċjati ma' riskju ogħla ta' problemi avversi tal-fwied, jekk il-pazjent ikollu HIV-RNA fil-plażma li seta' ġie ntraċċat -i.e. konċentrazzjoni ≥
English: The 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 uriet 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'esinofilja u sintomi sistemiċi karaterizzati b'raxx u sintomi fil-ġisem bħal deni, artalaġja, uġigħ fil-muskoli, u limfadenopatija, kif ukoll problemi vixxerali bħal epatite, kif ukoll eosinofilja, granuloċitopenija u disfunzjoni renali.
English: Greater than 80 % of the radioactivity in urine was made up of glucuronide conjugates of hydroxylated metabolites.
Maltese: Aktar minn 80% tar-radjuattività fl-awrina kienet magħmula minn metaboliti idrossilati ikkonġugati ma' glucuronide.
English: Fertility In reproductive toxicology studies, evidence of impaired fertility was seen in rats.
Maltese: Fi studji ta' tossikoloġija reproduttiva, evidenza ta' fertilità indebolita kienet tidher fil-firien.
English: Median age was 34 years and about 64% were male patients, median CD4 cell count was 170 and 190 cells per mm3 in the nevirapine twice daily and efavirenz groups, respectively.
Maltese: CD4 kien ta' 170 u 190 ċellula għal kull mm3 fil-gruppi ta' nevirapine li jittieħed darbtejn kuljum u efavirenz, rispettivament.
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/mm3 had a 12 fold higher risk of symptomatic hepatic adverse reactions compared to women with CD4 counts < 250 cells/mm3 (11.0 %
Maltese: F'reviżjooni retrospettiva prinċipalment ta' pazjenti b'ikkargar virali ta' effetti avversi epatiċi meta mqabbla ma' nisa b'livelli ta' ċelluli CD4 < 250 ċelluli/mm3 (11.0% kontra 0.9%).
English: Studies in treatment-experienced patients
Maltese: TAL-PRODOTT MEDIĊINALI
English: Coadministration of telaprevir and medicinal products that induce CYP3A and/or P-gp may decrease telaprevir plasma concentrations.
Maltese: għoti flimkien ta' telaprevir u prodotti mediċinali li jinduċu CYP3A u/jew P
English: The patients studied were receiving antiretroviral therapy containing nevirapine 200 mg twice daily for at least 6 weeks prior to pharmacokinetic sampling, with a median duration of therapy of 3.4 years.
Maltese: Il-pazjenti studjati kienu qed jirċievu terapija antiretrovirali li fiha nevirapine 200 mg darbtejn kuljum għal ta' lanqas 6 ġimgħat qabel ma ttieħdu l-kampjuni farmakokinetiċi, li damet sejra għal perijodu medjan ta' 3.4 snin.
English: In a 200 mg nevirapine single dose pharmacokinetic study of HIV-negative patients with mild and moderate hepatic impairment (Child-Pugh A, n=6; Child-Pugh B, n=4), a significant increase in the AUC of nevirapine was observed in one Child-Pugh B patient with ascites suggesting that patients with worsening hepatic function and ascites may be at risk of accumulating nevirapine in the systemic circulation.
Maltese: Fi studju farmakokinetiku b'doża waħda ta' 200 mg nevirapine fuq pazjenti b'riżultat negattiv ta' HIV b'indeboliment tal-fwied ħafif u moderat (Child-Pugh A, n=6; Child-Pugh B, n=4) żieda sinifikanti fl
English: Severe and life-threatening skin reactions have occurred in patients treated with nevirapine, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
Maltese: Kien hemm pazjenti li ġew ikkurati b'nevirapine u kellhom reazzjonijiet tal-ġilda qawwija jew li jistgħu jkunu ta' periklu għal ħajja, inklużi s-sindromu Stevens-Johnson (SJS) u nekroliżi epidermali tossika (TEN).
English: Fluconazole Cmin ↔ 0.93 (0.86-1.01) Fluconazole Cmax ↔ 0.92 (0.85-0.99)
Maltese: Fluconazole AUC ↔ 0.94 (0.88-1.01) Fluconazole Cmin ↔ 0.93 (0.86-1.01) Fluconazole Cmax ↔ 0.
English: The most common clinical toxicity of nevirapine is rash, with nevirapine attributable rash occurring in 12.5 % of patients in combination regimens in controlled studies.
Maltese: L-aktar tossiċità klinika komuni ta' nevirapine hija raxx b'raxx li jiġi attribwit għal nevirapine jaqbad lil 12.5% ta' pazjenti li jużaw nevirapine ma' mediċini oħrajn fi studji b'kontrolli.
English: Telaprevir is metabolised in the liver by CYP3A and is a P-glycoprotein substrate.
Maltese: Telaprevir jiġi metabolizzat fil-fwied minn CYP3A u hu subtrat ta' P
English: Summary of the safety profile
Maltese: Sommarju tal-profil ta' fertilità
English: Most of the experience with nevirapine is in combination with nucleoside reverse transcriptase inhibitors (NRTIs).
Maltese: L-aktar esperjenza miksuba b'nevirapine hija meta tintuża ma' impedituri ta' l-enzima nucleoside reverse transcriptase (NRTI's).
English: As serious and life threatening hepatotoxicity has been observed in controlled and uncontrolled studies predominantly in patients with a plasma HIV-1 viral load of 50 copies/ml or higher, nevirapine should not be initiated in adult females with CD4 cell counts greater than 250 cells/mm3 or in adult males with CD4 cell counts greater than 400 cells/mm3, who have a detectable plasma HIV-1 RNA unless the benefit outweighs the risk.
Maltese: Hekk kif epatotossiċità serja u ta' periklu għal ħajja ġiet osservata fi studji li saru kemm b'kontrolli u kemm mingħajr kontrolli prinċipalment f'pazjenti b'ikkargar virali ta' HIV-1 fil-plażma ta' 50 kopji/ml jew aktar nevirapine m'għandux jinbeda f'nisa adulti meta l-għadd ta' ċelluli CD4 tagħhom ikun ogħla minn 250 ċellula/mm3 jew f'irġiel adulti b'għadd ta' ċelluli ogħla minn 400 ċellula/mm3, li għandhom HIV-RNA fil-plażma li jista' jiġi intraċċat għajr meta l-benefiċċju jisboq ir-riskju.
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, dardir, remettar, suffejra FLIMKIEN MA' riżultati anormali tall-laboratorju (bħal anormalità moderata jew qawwija fil-funzjoni tal-fwied (minbarra fir-riżultat tal-GGT)), nevirapine għandu jitwaqqaf għal dejjem.
English: Careful monitoring of the therapeutic effectiveness of P450 metabolised medicinal products is recommended when taken in combination with nevirapine.
Maltese: Monitoraġġ bil-għaqal tal-effettività terapewtika ta' prodotti mediċinali mmetabolizzati minn P450 hu rrakkomandat meta jingħataw flimkien ma' nevirapine.
English: Metabolite 25-O-desacetylrifabutin
Maltese: Effetti sekondarji addizzjonali fit-tfal u l-adolexxenti
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: % kontra 2.2%) u pazjenti inkonsapevoli mit-trattament għandhom għadd akbar ta' CD4 fil-bidu tatterapija b'nevirapine huma f'riskju akbar li jkollhom każijiet sintomatiċi epatiċi avversi b'nevirapine.
English: Uncommon Stevens-Johnson syndrome/toxic epidermal necrolysis (which may be fatal)
Maltese: Mhux komuni sindromu ta' Stevens Johnson/nekrolisi tossika tal-ġilda (li tista' tkun fatali) (0.2%), anġjoedema, urtikarja
English: These have included cases of Stevens-Johnson syndrome, toxic epidermal necrolysis and hypersensitivity reactions characterised by rash, constitutional findings and visceral involvement.
Maltese: Dawn kienu jinkludu każijiet ta' sindromu Stevens-Johnson, nekroliżi epidermali tossika, reazzjonijiet ta' ipersensittività kkaratterizzati b'raxx, sinjali fuq il-ġisem u problemi tal-vixxri.
English: Hepatic-renal failure syndromes have been reported rarely.
Maltese: Sindromi ta' falliment tal- fwied u tal-kliewi ġew irrapportati rarament b'terapija ta' kombinazzjoni.
English: Investigations Common liver function tests abnormal (alanine aminotransferase increased; transaminases increased; aspartate aminotransferase increased; gamma-glutamyltransferase increased; hepatic enzyme increased; hypertransaminasaemia) Uncommon blood phosphorus decreased; blood pressure increased
Maltese: transaminases ogħla, aspartate aminotransferase ogħla, gamma-glutamyltransferase ogħla; enzima tal-fwied ogħla,
English: Cases of nevirapine overdose 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' nevirapine minn 800 sa 6,000 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 Nevirapine
Maltese: Dan hu importanti speċjalment fl-ewwel 14-il jum ta' kura (ara aktar informazzjoni f'”Kif għandek tieħu Nevirapine Teva”).
English: It is not recommended to coadminister atazanavir/ritonavir and Nevirapine Teva (see section
Maltese: Fosamprenavir/ritonavir u Nevirapine
English: A durable response to nevirapine for at least three years was documented in this study, and equivalence within a 10% range was demonstrated between nevirapine 200 mg twice daily and efavirenz with respect to treatment failure.
Maltese: Rispons fit-tul għal nevirapine għal tal-anqas tliet snin ġie dokumentat f'dan l-istudju u ekwivalenza f'medda ta' 10% ġiet murija bejn nevirapine 200 mg li jingħata darbtejn kuljum u efavirenz fir-rigward ta' falliment tal-kura.
English: Nevirapine Teva tablets contain lactose (milk sugar).
Maltese: Il-pilloli Nevirapine Teva fihom lactose (zokkor tal-ħalib).
English: 1.28 compared to historical controls.
Maltese: meta mqabbel ma' kontrolli storiċi.
English: In addition, the observed trough nevirapine concentrations were comparable between the two methods.
Maltese: nevirapine osservati kienu komparabbli fiż-żewġ metodi.
English: Nevirapine Cmin ↑ 1.32 (1.22-1.43) Nevirapine Cmax ↑ 1.17 (1.09-1.25)
Maltese: 32 (1.22-1.43) Nevirapine Cmin ↑ 1.17 (1.09-1.25)
English: The side effects described below have been experienced by patients given nevirapine:
Maltese: L-effetti sekondarji deskritti hawn taħt inħassu minn pazjenti li ngħataw neviparine:
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 radjutikkettat mhux mibdul fl-awrina (< 3% tad-doża totali).
English: - abdominal pain
Maltese: - uġigħ addominali
English: Genotypic analysis of isolates from antiretroviral naïve patients experiencing virologic failure (n=71) receiving nevirapine once daily (n=25) or twice daily (n=46) in combination with lamivudine and stavudine for 48 weeks showed that isolates from 8/25 and 23/46 patients, respectively, contained one or more of the following NNRTI resistance-associated substitutions:
Maltese: f'kombinazzjoni ma' lamivudine u stavudine għal 48 ġimgħa wriet li kampjuni minn 8/25 u 23/46 pazjent, rispettivament, kien fihom wieħed jew aktar mis-sostituzzjonijiet li ġejjin assoċjati mar-reżistenza ta' NNRTI:
English: Cobicistat, a cytochrome P450 3A inhibitor significantly inhibits hepatic enzymes, as well as other metabolic pathways.
Maltese: 3A, jinibixxi b'mod sinifikanti l enzimi tal-fwied, kif ukoll passaġġi metaboliċi oħrajn.
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, konġjunktivite, 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: Ribavirin does not inhibit cytochrome P450 enzymes, and there is no evidence from toxicity studies that ribavirin induces liver enzymes.
Maltese: Ribavirin ma jinibixxix l enzimi ta' ċitokrom P450, u m'hemm l-ebda evidenza minn studji dwar it tossiċità li ribavirin jinduċi l-enzimi tal-fwied.
English: Patients with rare hereditary problems of galactose intolerance e.g. galactosaemia, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjent li għandu problemi ereditarji rari ta' intolleranza għal gallatosju e.g. gallatosemija, id-defiċjenza ta' Lapp lactase jew problemi bl-assorbiment ta' glukosju-gallatosju m'għandux jieħu din il-mediċina.
English: The following adverse reactions have also been reported when nevirapine has been used in combination with other anti-retroviral agents: pancreatitis, peripheral neuropathy and thrombocytopaenia.
Maltese: Ir-reazzjonijiet avversi li ġejjin ġew irrapportati wkoll meta nevirapine intuża flimkien ma' sustanzi antiretrovirali oħra: pankreatite, newropatija periferali u tromboċitopenja.
English: Ketoconazole and erythromycin significantly inhibited the formation of nevirapine hydroxylated metabolites.
Maltese: nevirapine, huwa wkoll osservat aktar spiss fit-tfal.
English: There is not enough evidence to substantiate that the absence of an increased risk for toxicity seen in pretreated women initiating nevirapine with an undetectable viral load (less than 50 copies/ml of HIV-1 in plasma) and CD4 cell counts above 250 cells/mm3 also applies to pregnant women.
Maltese: M'hemmx biżżejjed evidenza li jissostanzza li n-nuqqas ta' riskju ogħla għal tossiċità li tidher f'nisa kkurati minn qabel li qed jibdew nevirapine b'ikkargar virali mhux intraċċat (inqas minn 50 kopja/m ta' HIV-1 fil-plażma) u fl-għadd ta' CD4 'il-fuq minn 250 ċellula/mm3 japplika wkoll għal nisa tqal.
English: Other published data support these conclusions.
Maltese: Informazzjoni oħra ppubblikata taqbel ma' dawn il-konklużjonijiet.
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 tal-linja bażi bejn iż-żewġ gruppi ta' kura.
English: How to store Nevirapine Teva
Maltese: Kif gћandek tieћu Nevirapine Teva
English: The double non-nucleoside study 2 NN was a randomised, open-label, multicentre prospective study comparing the NNRTIs nevirapine, efavirenz and both medicinal products given together.
Maltese: L-istudju double non-nucleoside 2 NN kien studju fortuwitu, bit-tikketta tidher, multiċentrali prospettiv li qabbel l-NNRTIs nevirapine, efavirenz u ż-żewġ prodotti mediċinali mogħtija flimkien. 1,216-il pazjent inkonsapevoli li qed jingħataw terapija antiretrovirali b'> 5,000 kopja/ml ta' RNA
English: Common (may affect up to 1 in 10 people): - decreased numbers of white blood cells (granulocytopenia) - allergic reactions (hypersensitivity) - headache - feeling sick (nausea) - vomiting - abdominal pain - loose stools (diarrhoea) - inflammation of the liver (hepatitis) - feeling tired (fatigue) - fever - abnormal liver function tests
Maltese: Mhux komuni: jistgħu jaffettwaw sa 1 minn kull 100 persuna - reazzjoni allerġika kkaraterizzata b'raxx, nefħa tal-wiċċ, diffikultà biex tieħu n-nifs (spażmu bronkjal)i jew xokk anafilattiku - tnaqqis fl-għadd ta' ċelluli ħomor tad-demm (anemija) - ġilda safranija (suffejra)
English: It is recommended that HIV-infected mothers do not breast-feed their infants to avoid risking postnatal transmission of HIV and that mothers should discontinue breast-feeding if they are receiving nevirapine.
Maltese: Huwa rrakkomandat li ommijiet infettati b'HIV ma jreddgħux lill-uliedhom biex jevitaw ir-riskju li jgħaddu l-HIV wara t-twelid u li l-ommijiet għandhom jieqfu jreddgħu jekk ikunu qed jieħdu nevirapine.
English: It is not recommended to coadminister rifampicin and Nevirapine Teva (see section 4.4).
Maltese: Mhux irrakkomandat li efavirenz u Nevirapine Teva (ara sezzjoni 4.4)
English: Due to the metabolic pathway of telbivudine, no clinically relevant drug-drug interaction is expected.
Maltese: telbivudine, l-ebda interazzjoni klinikament rilevanti bejn mediċina u oħra mhi mistennija.
English: No significant effect on rifabutin and nevirapine mean PK parameters is seen.
Maltese: Ma deher l-ebda effett sinifikanti fil-parametri PK medji ta' rifabutin u nevirapine.
English: This increased risk for toxicity based on CD4 count thresholds has not been detected in patients with undetectable (i.e. < 50 copies/ml) plasma viral load.
Maltese: Din iż-żieda fit tossiċità ibbażata fuq l-għadd ta' riferiment ta' CD4 għadha ma ġietx osservata f'pazjenti f'ikkargar virali ġol-plażma (i.e < 50 kopji/ml).
English: Osteonecrosis: Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART).
Maltese: Għalkemm l-etjoloġija hi kkonsidrata bħala multi-fattorjali (li tinkludi l-użu ta' kortikostirojd, konsum ta' alkoħol, immunosoppressjoni serja, indiċi tal-piż korporali ogħla), każijiet ta' osteonekrosi ġew irrapportati partikolarment f'pazjenti li għandhom marda ta' HIV avanzata u/jew espożizzjoni fuq tul ta' żmien għal terapija antiretrovirali konġunta (CART).
English: Due to the metabolic pathway of raltegravir no interaction is expected.
Maltese: Minħabba l-linja metabolika ta' raltegravir mhux mistenni li jkun hemm interazzjonijiet.
English: Increased ASAT or ALAT levels ≥ 2.5 ULN and/or co-infection with hepatitis B and/or C at the start of antiretroviral therapy is associated with greater risk of hepatic adverse reactions during antiretroviral therapy in general, including nevirapine containing regimens.
Maltese: terapija anti-retrovirali huma kollha fatturi assoċjati ma' żieda fir-risku ta' reazzjonijiet avversi filfwied, ġeneralment waqt kull terapija antiretrovirali, inkluż nevirapine.
English: Physicians and patients should be vigilant for prodromal signs or findings of hepatitis, such as anorexia, nausea, jaundice, bilirubinuria, acholic stools, hepatomegaly or liver tenderness.
Maltese: Kemm it-tobba kif ukoll il-pazjenti għandhom ikunu attenti ħafna għal sinjali prodromali jew riżultati ta' epatite, bħal anoreksja, dardir, suffejra, bilirubinurja, purgar lewn it-tafal, epatomegalija jew sensittività fil-fwied.
English: Due to the metabolic pathway of entecavir, no clinically relevant drug-drug interaction is expected.
Maltese: Minħabba l-passaġġ metaboliku ta' entecavir, l-ebda interazzjoni klinikament rilevanti bejn mediċina u oħra mhi mistennija.
English: Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Maltese: Pazjenti li jsofru b'mod kroniku minn epatite B jew Ċ, u li jkunu qegħdin taħt terapija antiretrovirali kkombinata, huma aktar predisposti għal mard qawwi jew fatali tal-fwied.