FrancophonIA/ELRC3.0 huggingface dataset:
English: Of these 50 patients, 28 developed resistance to efavirenz and 39 developed resistance to etravirine (the most frequently emergent resistance mutation being Y181C).
Maltese: Minn dawn il-50 pazjent, 28 żviluppaw reżistenza għal efavirenz u 39 żviluppaw reżistenza għal etravirine (l-iktar mutazzjoni ta' reżistenza emerġenti frekwenti kienet Y181C).
English: Viramune contains sucrose, sorbitol, methyl parahydroxybenzoate, propyl parahydroxybenzoate and sodium
Maltese: Viramune fih sucrose, sorbitol, methyl parahydroxybenzoate, propyl parahydroxybenzoate u sodium
English: Cartons containing 2 blister cards (14 tablets).
Maltese: Kartun li fihom 2 strixxi (14-il pillola).
English: Boehringer Ingelheim Pharma GmbH & Co. KG Binger Strasse 173 - 55216 Ingelheim am Rhein Germany
Maltese: KG Binger Strasse 173 - 55216 Ingelheim am Rhein Il-Ġermanja
English: - weigh 50 kg or more
Maltese: - jiżnu 50 kg jew aktar
English: Viramune oral suspension is supplied in plastic bottles of suspension for oral use, with 240 ml suspension per bottle.
Maltese: Is-suspensjoni orali Viramune tiġi fi fliexken tal-plastik għal suspensjoni għal użu orali, li tesa' 240 ml suspensjoni kull flixkun.
English: The most frequently observed laboratory test abnormalities are elevations in liver function tests (LFTs), including ALAT, ASAT, GGT, total bilirubin and alkaline phosphatase.
Maltese: L-aktar abnormalitajiet komuni li jirriżultaw minn testijiet tal-laboratorju huma żjidiet fil-fatturi mkejla permezz ta' testijiet tal-funzjoni tal-fwied (LFTs), li jinkludu ALAT, ASAT, GGT, bilirubin totali u alkaline phosphatase.
English: Pharmacokinetic data on 33 patients (age range 0.77 - 13.7 years) in the intensive sampling group demonstrated that clearance of nevirapine increased with increasing age in a manner consistent with increasing body surface area.
Maltese: Data farmakokinetika fuq 33 pazjent (età mifruxa bejn 0.77 - 13.7 sena) fil-grupp ta' kampjuni intensivi wriet li r-rata ta' eliminazzjoni ta' nevirapine żdiedet meta l-età żdidet b'mod konsistenti ma' żjieda fl-erja superfiċjali korporali.
English: In the multinational 2NN study, a population pharmacokinetic substudy of 1,077 patients was performed that included 391 females.
Maltese: Fl-istudju multinazzjonali 2NN, sar sottostudju farmakokinetiku tal-popolazzjoni fuq 1077 pazjent li kien jinkludi 391 mara.
English: Viramune 200 mg Tablets
Maltese: Viramune 200 mg pilloli
English: Of the patients with grade 3 or 4 liver-associated laboratory toxicity, the proportions coinfected with hepatitis B or hepatitis C virus were 6.7 % and 20.0 % in the nevirapine twice daily group, 5.6 % and 11.1 % in the efavirenz group.
Maltese: Mill-pazjenti b'tossiċità tal-laboratorju ta' grad 3 jew 4 assoċjata mal-fwied, il-proporzjonijiet koinfettati bl-epatite B jew bl-epatite Ċ kienu 6.7% u 20.0% fil-grupp ta' nevirapine li ngħata darbtejn kuljum, 5.6% u 11.1% fil-grupp ta' efavirenz.
English: Coadministration with herbal preparations containing St. John's wort (Hypericum perforatum) due to the risk of decreased plasma concentrations and reduced clinical effects of nevirapine (see section 4.5).
Maltese: John's Wort (Hypericum perforatum) minħabba r-riskju li jitnaqqsu l-livelli ta' konċentrazzjonijiet ta' plażma kif ukoll l-effetti kliniċi ta' nevirapine (ara sezzjoni 4.5).
English: An increase in the dose of lopinavir/ritonavir to 533/133 mg (4 capsules) or 500/125 mg (5 tablets with 100/25 mg each) twice daily with food is recommended in combination with Viramune.
Maltese: Żieda fid-doża ta' lopinavir/ritonavir għal 533/133 mg (4 kapsuli) jew 500/125 mg (5 pilloli b'100/25 mg kull darba) darbtejn kuljum mal-ikel hi rakkomandata flimkien ma' Viramune.
English: Metabolite 14-OH clarithromycin AUC  1.42 (1.16-1.73) Metabolite 14-OH clarithromycin Cmin  0 (0.68-1.49) Metabolite 14-OH clarithromycin Cmax  1.47 (1.21-1.80)
Maltese: AUC  1.42 (1.16-1.73) għal metabolit 14-OH clarithromycin Cmin  0 (0.68-1.49) għal metabolit 14-OH clarithromycin Cmax  1.47 (1.21-1.80) għal metabolit 14-OH clarithromycin
English: In ACTG 245, a double-blind placebo controlled study, the frequency of serious medicinal product-related granulocytopenia was 5/305 (1.6 %).
Maltese: F'ACTG 245, studju double-blind li sar bi plaċebo bħala kontroll, il-frekwenza ta' granuloċitopenija relatata mal-prodott mediċinali kienet ta' 5/305 (1.6%).
English: Absolute bioavailability in 12 healthy adults following single-dose administration was 93  9 % (mean SD) for a 50 mg tablet and 91  8 % for an oral solution.
Maltese: Il-bijodisponibilità assoluta fi 12-il adult b'saħħithom, wara li ngħataw doża waħda kienet ta' 93  9% (SD medja) għal pillola ta' 50 mg u ta' 91  8% għal soluzzjoni orali.
English: 3 for women and <400 cells/mm
Maltese: 3 għan-nisa u <400 ċelluli/mm
English: - The other ingredients are lactose (as monohydrate), hypromellose, iron oxide yellow and magnesium stearate.
Maltese: - Is-sustanzi mhux attivi l-oħra huma lactose (bħala monohydrate), hypromellose, iron oxide yellow u magnesium stearate.
English: Genotypic analysis showed mutations in the HIV-1 RT gene Y181C and/or V106A depending upon the virus strain and cell line employed.
Maltese: Analiżi ġenotipika wriet mutazzjonijiet fil-ġene RT Y181C u/jew V106A ta' HIV-1 skont ir razza tal-virus u r-razza ta' ċelluli użati.
English: Nevirapine pharmacokinetics in HIV-1 infected adults does not appear to change with age (range 1868 years).
Maltese: Il-farmakokinetika ta' nevirapine f'persuni adulti infettati bl-HIV-1 ma tidhirx li tinbidel mal-età (medda 18-68 sena).
English: Female gender and higher CD4 counts (>250/mm
Maltese: Sess femminili u għadd ogħla ta' ċelluli CD4 (>250/mm
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/055/007 (30 tablets, bottle) EU/1/97/055/008 (30 tablets, blister) EU/1/97/055/009 (90 tablets, blister)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/97/055/007 (30 pillola, flixkun) EU/1/97/055/008 (30 pillola, folja)
English: (compared to 300/100mg without nevirapine)
Maltese: (meta mqabbel ma' 300/100mg mingħajr nevirapine)
English: Cross resistance to delavirdine and efavirenz is expected after virologic failure with nevirapine.
Maltese: Reżistenza inkroċjata għal delavirdine u efavirenz hija mistennija wara falliment viroloġiku b'nevirapine.
English: 1,216 antiretroviral-therapy naïve patients with plasma HIV-1 RNA > 5,000 copies/ml at baseline were assigned to Viramune 400 mg once daily, Viramune 200 mg twice daily, efavirenz 600 mg once daily, or Viramune (400 mg) and efavirenz (800 mg) once daily, plus stavudine and lamivudine for 48 weeks.
Maltese: 1,216-il pazjent inkonsapevoli li qed jingħataw terapija antiretrovirali b'> 5000 kopja/ml ta' RNA tal-HIV-1 fil-plażma fil-linja bażi ġew assenjati Viramune 400 mg darba kuljum, Viramune 200 mg darbtejn kuljum, efivirenz 600 mg darba kuljum, jew Viramune (400 mg) u efivarenz (800 mg) darba kuljum, flimkien ma' stavudine u lamivudine għal 48 ġimgħa.
English: Viramune is also available as 200 mg tablets for adults (16 years of age and older).
Maltese: Viramune huwa wkoll disponibbli f'pilloli ta' 200 mg għall-adulti (16-il sena jew aktar).
English: Cimetidine: no significant effect on cimetidine PK parameters is seen.
Maltese: Cimetidine: ma deher l-ebda effett sinifikanti fil-parametri PK ta' cimetidine.
English: Rare hepatitis fulminant (which may be fatal)
Maltese: Rari epatite fulminanti (li tista' tkun fatali)
English: Viramune 50 mg/5 ml Oral suspension and Viramune 400 mg and 100 mg prolonged-release tablets
Maltese: Viramune 50 mg/5 ml suspensjoni orali u Viramune 400 mg u 100 mg pilloli li jerħu l-mediċina bilmod
English: There are toxicities that require interruption of Viramune therapy (see section 4.4).
Maltese: Hemm tossiċitajiet li jeħtieġu l-interruzzjoni tat-terapija b'Viramune (ara sezzjoni 4.4).
English: Hepatic-renal failure syndromes have been reported rarely.
Maltese: Sindromi ta' falliment epatiku u renali ġew rapportati rarament b'terapija ta' kombinazzjoni.
English: The 14-day ”lead-in” period has been shown to lower the risk of skin rash.
Maltese: Il-perijodu “inizjali” ta' 14-il jum intwera li jnaqqas ir-riskju ta' raxx fuq il-ġilda.
English: Efavirenz AUC  0.72 (0.66-0.86) Efavirenz Cmin  0.68 (0.65-0.81) Efavirenz Cmax  0.88 (0.77-1.01)
Maltese: 72 (0.66-0.86) Efavirenz Cmin  0.68 (0.65-0.81) Efavirenz Cmax  0.88 (0.77-1.01)
English: Adult patients:
Maltese: Pazjenti adulti:
English: Zidovudine AUC  0.72 (0.60-0.96) Zidovudine Cmin ND Zidovudine Cmax  0.70 (0.49-1.04)
Maltese: 72 (0.60-0.96) Zidovudine Cmin ND Zidovudine Cmax  0.70 (0.49-1.04)
English: Viramune 200 mg tablets nevirapine
Maltese: Viramune 200 mg pilloli nevirapine
English: Furthermore, combining the following compounds with Viramune is not recommended: efavirenz, ketoconazole, delavirdine, etravirine, rilpivirine, elvitegravir (in combination with cobicistat), atazanavir (in combination with ritonavir), boceprevir; fosamprenavir (if not co-administered with low dose ritonavir) (see section 4.5).
Maltese: Flimkien ma' dan, li tikkombina l-komposti li ġejjin ma' Viramune mhuwiex rakkomandat: efavirenz, ketoconazole, delavirdine, etravirine, rilpivirine, elvitegravir (flimkien ma' cobicistat), atazanavir (flimkien ma' ritonavir), boceprevir; fosamprenavir (jekk ma jingħatax flimkien ma' doża baxxa ta' ritonavir) (ara sezzjoni 4.5).
English: Baseline CD4 count (cells/mm - Mean (SD)
Maltese: Għadd ta' CD4 fil-linja bażi (ċelluli/mm - Medja (SD)
English: Each tablet contains 200 mg nevirapine.
Maltese: Kull pillola fiha 200 mg nevirapine.
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 każwali, bit-tikketta tidher, multiċentrali prospettiv li qabbel l-NNRTIs nevirapine, efavirenz u ż-żewġ prodotti mediċinali mogħtija flimkien.
English: Because the clarithromycin active metabolite has reduced activity against Mycobacterium aviumintracellulare complex overall activity against the pathogen may be altered.
Maltese: Peress li l-metabolit attiv ta' clarithromycin għandu attività mnaqqsa kontra l-kumpless intraċellulari ta' Mycobacterium avium, l-attività globali kontra l-patoġenu tista' tinbidel.
English: Baseline Plasma HIV-1 RNA (log10 copies/ml) - Mean (SD)
Maltese: HIV-1 RNA fil-Plażma fil-Linja Bażi (log10 kopji/ml) - Medja (SD)
English: Baseline (mean) n=505
Maltese: Linja bażi (medja) n=505
English: Gender - Male - Female
Maltese: Sess - Irġiel - Nisa
English: Telbivudine is not a substrate, inducer or inhibitor of the cytochrome P450 (CYP450) enzyme system.
Maltese: Telbivudine mhuwiex substrat, induttur jew inibitur tas-sistema ta' enzimi ta' ċitokrom P450 (CYP450).
English: Nevirapine had no antiviral activity in cell culture against group O HIV-1 isolates or HIV-2 isolates.
Maltese: Nevirapine ma kellux attività antivirali fil-koltura ta' ċelluli kontra kampjuni HIV-1 jew HIV-2 minn grupp O.
English: Nevirapine AUC  1.20 Nevirapine Cmax  1.20
Maltese: Nevirapine Cmax  1.20
English: Sodium hydroxide (for pH-adjustment) Purified water
Maltese: Sodium hydroxide (għal aġġustament ta' pH)
English: The most common clinical toxicity of nevirapine is rash.
Maltese: L-aktar tossiċità klinika komuni ta' nevirapine hija raxx.
English: Baseline (mean) n=503
Maltese: Linja bażi (medja) n=503
English: Excipients: includes sucrose, sorbitol, methyl parahydroxybenzoate, propyl parahydroxybenzoate (see leaflet for further information)
Maltese: Eċċipjenti: jinkludu sukrożju, sorbitol, methyl parahydroxybenzoate, propyl parahydroxybenzoate (ara l-fuljett għal aktar informazzjoni)
English: The frequency category was estimated from a statistical calculation based on the total number of patients exposed to nevirapine in randomised controlled clinical studies (n=2,718).
Maltese: Il-kategorija ta' frekwenza ġiet stmata mill-kalkulazzjoni statistika bbażata fuq in-numru totali ta' pazjenti esposti għal nevirapine fi studji kliniċi kkontrollati li fihom il-parteċipanti ntgħażlu b'mod każwali (n=2,718).
English: Clear low density polyethylene bottle-syringe adapter.
Maltese: Adapter tal-flixkun siringa magħmula minn low density polyethylene ċar.
English: Each ml of oral suspension contains 10 mg of nevirapine (as hemihydrate).
Maltese: Kull ml ta' suspensjoni orali fiha 10 mg/ml ta' nevirapine (bħala hemihydrate).
English: Viramune.
Maltese: ULN.
English: 3 (6.3 % versus 1.2 % for men with CD4 counts <400 cells/mm
Maltese: 3 (6.3% kontra 1.2%) meta mqabbla ma' dawk l-irġiel li għandhom l-għadd ta' ċelluli CD4 <400 ċelluli/mm
English: Gender and elderly
Maltese: Għall-adulti
English: clinically relevant drug-drug interaction is expected.
Maltese: Lebda interazzjoni klinikament rilevanti bejn mediċina u oħra mhi mistennija.
English: After 14 days, the usual dose is 20 ml (200 mg) twice a day.
Maltese: Wara 14-il jum, id-doża li ġeneralment tingħata hi ta' 20 ml (200 mg) darbtejn kuljum.
English: Atazanavir/r AUC  0.81 (0.65-1.02) Atazanavir/r Cmin  0.41 (0.27-0.60) Atazanavir/r Cmax  1.02 (0.85
Maltese: Atazanavir/r 400/100mg Atazanavir/r AUC  0.81 (0.65-1.02) Atazanavir/r Cmin  0.41 (0.27-0.60)
English: Each 5 ml contains 50 mg of the active substance nevirapine (as hemihydrate).
Maltese: Kull 5 ml ta' Viramune suspensjoni orali fiha 50 mg tassustanza attiva nevirapine (bħala hemihydrate).
English: phase IIa study in HIV-infected patients have shown a clinically non significant 20% decrease of TPV Cmin..
Maltese: IIa f'pazjenti infettati bl-HIV wera tnaqqis mhux klinikament sinifikanti ta' 20% fisCmin ta' TPV.
English: Viramune is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infected adults, adolescents, and children of any age (see section 4.2).
Maltese: Viramune huwa indikat biex jingħata flimkien ma' prodotti mediċinali anti-retrovirali oħra għattrattament ta' adulti, adolexxenti u tfal ta' kwalunkwe età infettati bl-HIV-1 (ara sezzjoni 4.2).
English: Nevirapine: compared to historical controls, levels appeared to be unchanged.
Maltese: Nevirapine: meta tqabbel ma' kontrolli storiċi, il-livelli dehru li ma tbiddlux.
English: 55216 Ingelheim am Rhein, Germany
Maltese: 55216 Ingelheim am Rhein, Il-Ġermanja
English: severe and life-threatening hepatotoxicity)(0.09%) Skin and subcutaneous tissue disorders Common rash (6.7 %)
Maltese: Komuni epatite (li tinkludi epatotossiċità severa u ta' periklu għall-ħajja) (0.09%) Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda Komuni raxx (6.7%)
English: Significantly fewer patients in the abacavir group (9 patients, or 6 %) than in the nevirapine group (26 patients, or 17 %) or the efavirenz group (27 patients, or 17 %) discontinued the medicinal product because of adverse events.
Maltese: Sinifikament inqas pazjenti fil-grupp ta' abacavir (9 pazjenti, jew 6%) milli fil-grupp ta' nevirapine (26 pazjent, jew 17%) jew fil-grupp ta' efavirenz (27 pazjent, jew 17%) waqqfu l-prodott mediċinali minħabba każijiet avversi.
English: This is a retrospective multicentre study comparing the 3-year antiviral efficacy of Viramune and efavirenz in combination with stavudine and lamivudine in 2NN patients from week 49 to week 144.
Maltese: Dan huwa studju multiċentrali retrospettiv li jqabbel l-effikaċja antivirali ta' 3 snin ta' Viramune u efivarenz f'kombinazzjoni ma' stavudine u lamivudine f'pazjenti 2NN mill-ġimgħa 49 sal-ġimgħa 144.
English: Coadministration of telaprevir and medicinal products that induce CYP3A and/or P-gp may decrease telaprevir plasma concentrations.
Maltese: Lgħoti flimkien ta' telaprevir u prodotti mediċinali li jinduċu CYP3A u/jew P-gp jista' jnaqqas ilkonċentrazzjonijiet ta' telaprevir filplażma.
English: Dosage:
Maltese: Lactose:
English: Week 48 (mean) n=407
Maltese: Ġimgħa (medja) n=407
English: Each bottle contains 240 ml of oral suspension.
Maltese: Kull flixkun fih 240 ml ta' suspensjoni orali.
English: Similar EC50 values are obtained when the antiviral activity of nevirapine is measured in peripheral blood mononuclear cells, monocyte derived macrophages or lymphoblastoid cell line.
Maltese: Valuri simili ta' EC50 kienu miksuba meta l-attivita antivirali ta' nevirapine ġiet imkejla f'ċelluli mononukleari, makrofagi derivati minn monoċiti jew f'razza ta' ċelluli limfoblastojdi fid-demm periferali.
English: Viramune is contraindicated in patients with severe hepatic impairment (Child-Pugh C, see section 4.3).
Maltese: Viramune huwa kontra-indikat f'pazjenti li għandhom indeboliment qawwi fil-fwied (Child-Pugh C, ara sezzjoni 4.3).
English: The study randomly assigned 460 adults who were taking two nucleoside reverse-transcriptase inhibitors and at least one PI and whose plasma HIV-1 RNA levels had been less than 200 c/ml for at least the previous six months to switch from the PI to Viramune (155 patients), efavirenz (156), or abacavir (149).
Maltese: L-istudju assenja b'mod każwali 460 adult li kienu qed jieħdu żewġ impedituri tat-tip nucleoside reverse-transcriptase u tal-anqas PI wieħed u li l-RNA ta' HIV-1 fil-plażma tagħhom kienet inqas minn 200 kopji/ml għal tal-anqas l-aħħar sitt xhur preċedenti biex jinqalbu minn PI għal Viramune (155 pazjent), efavirenz (156 pazjent) jew abacavir (149 pazjent).
English: When Viramune prolonged-release was dosed with a high fat meal, the nevirapine AUC0-24,ss and Cmin,ss were approximately 94 % and 98 %, respectively, of the AUC0-24,ss and Cmin,ss measured when patients were dosed with Viramune immediate-release tablets.
Maltese: Meta Viramune li jerħi l-mediċina bil-mod ġie ddożat ma' ikla b'ħafna xaħam, l-AUC ta' nevirapine024,ss u Cmin,ss kienet ta' madwar 94% and 98%, rispettivament, tal-AUC0-24,ss u Cmin,ss imkejla meta lpazjenti ġew iddożati b'Viramune pilloli li jerħu l-mediċina fil-pront.
English: Very common rash (12.5 %)
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda Komuni ħafna raxx (12.5%)
English: Entecavir is not a substrate, inducer or an inhibitor of cytochrome P450 (CYP450) enzymes.
Maltese: Entecavir mhuwiex subtrat, induttur jew inibitur tal-enzimi ta' ċitokrom P450 (CYP450).
English: Polyvinyl chloride (PVC)/aluminium foil push-through blister units (blister card of 7 tablets).
Maltese: Strixxa ta' polyvinyl chloride (PVC)/aluminju magħmula minn bżieżaq singoli li timbotta (strixxa ta' 7 pilloli).
English: In clinical studies, Viramune has been associated with an increase in HDL- cholesterol and an overall improvement in the total to HDL-cholesterol ratio.
Maltese: Fi studji kliniċi, Viramune ġie assoċjat ma' żieda fl-HDL kolesterol u titjib globali fil-proporzjon ta' total għal kolesterol mal-HDL kolesterol.
English: Hepatic impairment:A steady state study comparing 46 patients with mild (n=17: Ishak Score 1-2), moderate (n=20; Ishak Score 3-4), or severe (n=9; Ishak Score 5-6, Child-Pugh A in 8 pts., for 1 Child-Pugh score not applicable) liver fibrosis as a measure of hepatic impairment was conducted.
Maltese: Indeboliment fil-fwied: Sar studju ta' stadju fiss li qabbel 46 pazjent ma' fibrosi tal-fwied (n=17: Punteġġ Ishak 1-2), moderata (n=20; Punteġġ Ishak 3-4), jew qawwija (n=9; Punteġġ Ishak 5-6, Child-Pugh A fi 8 pti., mhux applikabbli għal punteġġ ChildPugh 1) bħala kejl ta' indeboliment renali.
English: Isolated cases of Stevens-Johnson syndrome or Stevens-Johnson/toxic epidermal necrolysis transition syndrome have been reported in this population.
Maltese: F'din il-popolazzjoni ġew irrapportati każijiet iżolati ta' sindromu ta' Stevens-Johnson jew sindromu ta' transazzjoni Stevens-Johnson/ nekroliżi epidermali tossika.
English: ANTIFUNGALS Fluconazole
Maltese: Saquinavir/ritonavir
English: Baseline HIV−1 viral load stratum (copies/ml)
Maltese: Stratus tal-ammont virali fillinja bażi HIV-1 (kopji/ml)
English: Hepatic impairment: A steady state study comparing 46 patients with mild (n=17: Ishak Score 1-2), moderate (n=20; Ishak Score 3-4), or severe (n=9; Ishak Score 5-6, Child-Pugh A in 8 pts., for 1 Child-Pugh score not applicable) liver fibrosis as a measure of hepatic impairment was conducted.
Maltese: Indeboliment fil-fwied: Sar studju ta' stadju fiss li qabbel 46 pazjent ma' fibrosi tal fwied ħafifa (n=17: Punteġġ Ishak 1-2), moderata (n=20; Punteġġ Ishak 3-4), jew qawwija (n=9; Punteġġ Ishak 5-6, Child-Pugh A fi 8 pti., mhux applikabbli għal punteġġ ChildPugh 1) bħala kejl ta' indeboliment renali.
English: Data concerning the pharmacokinetics of nevirapine has been derived from two major sources: a 48 week paediatric study in South Africa (BI 1100.1368) involving 123 HIV-1 positive, antiretroviral naïve patients aged 3 months to 16 years; and a consolidated analysis of five Paediatric AIDS Clinical Trials Group (PACTG) protocols comprising 495 patients aged 14 days to 19 years.
Maltese: Data rigward il-farmakokinetika ta' nevirapine nkisbet minn żewġ sorsi ewlenin: studju pedjatriku ta' 48 ġimgħa (BI 1100.1368) li sar fl-Afrika t'Isfel li kien jinvolvi 123 HIV-1 pazjenti pożittivi li huma inkonsapevoli li qed jieħdu mediċina antiretrovirali bejn l-etajiet ta' 3 xhur u 16-il sena; u analiżi konsolidata ta' ħames protokolli tal-Paediatric AIDS Clinical Trials Group (PACTG) li kellhom 495 pazjent bejn l-etajiet ta' 14-il jum u 19-il sena.
English: Fertility In reproductive toxicology studies, evidence of impaired fertility was seen in rats.
Maltese: Fi studji dwar tossikoloġija riproduttiva, kienet osservata evidenza ta' indeboliment fil-fertilità filfirien.
English: Nevirapine is a non-competitive inhibitor of the HIV-1 reverse transcriptase, but it does not have a biologically significant inhibitory effect on the HIV-2 reverse transcriptase or on eukaryotic DNA polymerases , , , or .
Maltese: Nevirapine huwa impeditur mhux kompettitiv bl-HIV-1 reverse transcriptase, imma m'għandux effett inibitorju bijoloġikament sinifikanti fuq HIV-2 reverse transcriptase jew fuq DNA polymerases , , , jew .
English: Both, the primary (p = 0.92) and secondary endpoints showed no statistically significant differences between efavirenz and Viramune 200 mg twice daily.
Maltese: Kemm, il-punt ta' riferenza prinċipali (p = 0.92) u dak sekondarju ma wrew ebda differenza statistikament sinifikanti bejn efavirenz u Viramune 200 mg li ingħata darbtejn kuljum.
English: Absorption: Nevirapine is readily absorbed (> 90 %) after oral administration in healthy volunteers and in adults with HIV-1 infection.
Maltese: Nevirapine ġie assorbit mill-ewwel (> 90%) wara li ngħata mill-ħalq f'voluntieri b'saħħithom u adulti infettati b'HIV-1.
English: Polyvinyl chloride (PVC)/aluminium foil push-through blister units (blister card of 10 tablets).
Maltese: Strixxa ta' polyvinyl chloride (PVC)/aluminju magħmula minn bżieżaq singoli li timbotta (strixxa ta' 10 pilloli).
English: Uncommon Stevens-Johnson syndrome/ toxic epidermal necrolysis (which may be fatal)
Maltese: Johnson/nekrolisi epidermali tossika)
English: The proportion of patients with at least one grade 3 or 4 liver-associated laboratory toxicity was 8.3 % for nevirapine twice daily and 4.5 % for efavirenz.
Maltese: Il-proporzjon ta' pazjenti b'tal-anqas tossiċità waħda tal-laboratorju ta' grad 3 jew 4 assoċjata mal-fwied kien ta' 8.3% għal nevirapine li ngħata darbtejn kuljum u 4.5% għal efavirenz.
English: The recommended dose for Viramune is 20 ml (200 mg) oral suspension once daily for the first 14 days (this lead-in period should be used because it has been found to lessen the frequency of rash), followed by 20 ml (200 mg) oral suspension twice daily, in combination with at least two additional antiretroviral agents.
Maltese: Id-doża rakkomandata ta' Viramune hi ta' 20 ml (200 mg) suspensjoni orali darba kuljum għal 14-il jum (dal-perijodu ta' introduzzjoni huwa meħtieġ għax instab li titnaqqas l-frekwenza li jitrabba raxx), segwit minn 20 ml (200 mg) suspensjoni orali darbtejn kuljum, flimkien ma' mill-anqas żewġ sustanzi anti-retrovirali.
English: Due to the metabolic pathway no clinically significant pharmacokinetic interactions are expected between enfuvirtide and nevirapine.
Maltese: Minħabba l-passaġġ metaboliku mhux mistenni li jkun interazzjonijiet farmakokinetiċi klinikament sinifikanti bejn enfuvirtide u nevirapine.