FrancophonIA/ELRC3.0 huggingface dataset:
English: 3 had a 12 fold higher risk of symptomatic hepatic adverse reactions compared to women with CD4 counts <250 cells/mm versus 0.9 %).
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 kontra 0.9%).
English: Cobicistat, a cytochrome P450 3A inhibitor significantly inhibits hepatic enzymes, as well as other metabolic pathways.
Maltese: Cobicistat, inibitur ta' ċitokrom P450 3A, jinibixxi b'mod sinifikanti l-enzimi tal-fwied, kif ukoll passaġġi metaboliċi oħrajn.
English: It is important that the entire measured dose of Viramune oral suspension is administered.
Maltese: Hu importanti li tingħata d-doża kollha mkejla ta' Viramune suspensjoni orali.
English: Careful monitoring of the therapeutic effectiveness of P450 metabolised medicinal products is recommended when taken in combination with nevirapine.
Maltese: Monitoraġġ kawt ta' l-effettività terapewtika ta' prodotti mediċinali metabolizzati minn P450 hu rakkomandat meta jingħataw flimkien ma' nevirapine.
English: Decreased blood phosphorus and increased blood pressure were observed in clinical studies with coadministration of tenofovir/emtricitabine.
Maltese: Tnaqqis tal-phosphorus fid-demm u żieda fil-pressjoni tad-demm ġew osservati fi studji kliniċi blgħoti flimkien ta' tenofovir/emtricitabine.
English: The interaction data is presented as geometric mean value with 90% confidence interval (90% CI) whenever these data were available.
Maltese: Id-data dwar l-interazzjonijiet hu ppreżentat bħala valur ġeometriku medju b'intervall ta' kunfidenza ta' 90% (90% CI) kull meta dawn il-valuri kienu disponibbli.
English: Renal impairment (mild, moderate and severe) resulted in no significant change in the pharmacokinetics of nevirapine.
Maltese: Indeboliment (ħafif, moderat, u qawwi) ma rriżulta flebda bidla sinifikanti fil-farmakokinetika ta' nevirapine.
English: High density polyethylene (HDPE) plastic bottle, with a plastic cap and an induction foil seal liner.
Maltese: Flixkun tal-plastik ta' densità għolja tal-polyethylene (HDPE), b'tapp tal-plastik u inforra ta' siġill ta' fojl tal-induzzjoni.
English: MARKETING AUTHORISATION HOLDER Boehringer Ingelheim International GmbH Binger Strasse 173
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Boehringer Ingelheim International GmbH Binger Strasse 173
English: Insert the syringe into the adapter.
Maltese: Daħħal is-siringa fl-adapter.
English: Package leaflet: Information for the user Viramune 50 mg/5 ml oral suspension nevirapine
Maltese: Informazzjoni għall-utent Viramune 50 mg/5ml suspensjoni orali nevirapine
English: The nevirapine AUC0-24,ss and Cmin,ss measured after 19 days of fasted dosing of Viramune 400 mg prolonged-release tablets once daily were approximately 80 % and 90 %, respectively, of the AUC0-24,ss and Cmin,ss measured when patients were dosed with Viramune 200 mg immediate-release tablets twice daily.
Maltese: LAUC0-24,ss ta' nevirapine u Cmin,ss imkejla wara 19-il jum ta' dożaġġ mogħti fl-istat sajjem ta' Viramune 400 mg pilloli li jerħu bil-mod darba kuljum kienet ta' madwar 80% u 90%, rispettivament, tal-AUC024,ss u Cmin,ss imkejla meta l-pazjenti ngħataw doża b'Viramune 200 mg pilloli li jerħu l-mediċina filpront darbtejn kuljum.
English: NEFA study
Maltese: Studju NEFA
English: This study demonstrated a significant reduction in transmission using single dose nevirapine (13.1 % (n = 310) in the Viramune group, versus 25.1 % (n = 308) in the ultra-short zidovudine group (p = 0.00063)).
Maltese: Dan l-istudju wera tnaqqis sinifikanti fit-trasmissjoni bl-użu ta' doża waħda ta' nevirapine (13.1% (n = 310) fil-grupp ta' Viramune, kontra 25.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucosegalactose malabsorption should not take this medicine.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas totali ta' lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: Approximately half of the patients had tenofovir + emtricitabine as their background therapy, with the remaining patients receiving abacavir sulfate + lamivudine or zidovudine + lamivudine.
Maltese: Madwar nofs il-pazjenti kellhom tenofovir + emtricitabine bħala t-terapija tagħhom fl-isfond, bil-pazjenti li kien fadal jirċievu abacavir sulfate + lamivudine jew zidovudine + lamivudine.
English: Granulocytopenia is commonly associated with zidovudine.
Maltese: Granuloċitopenija komunement hi assoċjata ma' zidovudine.
English: Patients with CLcr  20 ml/min do not require a dose adjustment, see section 5.2.
Maltese: Pazjenti b'CLcr  20 ml/min ma jinħteġux aġġustament fid-doża, ara sezzjoni 5.2.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg of nevirapine (as anhydrous).
Maltese: Kull pillola fiha 200 mg ta' nevirapine (bħala anhydrous).
English: Cross-resistance
Maltese: Fertilità
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 vixxerali, bħal epatite, eosinofilja, granuloċitopenija, u disfunzjoni renali), ara sezzjoni 4.4.
English: White high density polyethylene (HDPE) bottle with two piece child-resistant closure (outer shell white high density polyethylene, inner shell natural polypropylene) with a low density polyethylene (LDPE) foam liner.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Flixkun ta' high density polyethylene (HDPE) abjad b'tapp magħmul minn żewġ partijiet reżistenti biex ma jiftħuħx it-tfal (il-qoxra ta' barra magħmula minn high density polyethylene abjad u ta' ġewwa minn polyethylene naturali) b'inforra tal-foam magħmula minn low density polyethylene (LDPE).
English: Nevirapine has not been specifically investigated in patients over the age of 65.
Maltese: Nevirapine ma ġiex speċifikament studjat f'pazjenti 'l fuq minn 65 sena.
English: INFORMATION IN BRAILLE viramune 400 mg prolonged-release tablets
Maltese: INFORMAZZJONI BIL-BRAILLE viramune 400 mg pilloli li jerħu l-mediċina bil-mod
English: Dividing a 200 mg total dose into four 50 mg doses rather than two 100 mg doses produced a 7-11 % greater overall absorption, but with comparable medicinal product release rates.
Maltese: Il-qsim tad-doża totali ta' 200 mg f'erba' dożi ta' 50 mg minflok żewġ dożi ta' 100 mg, ipproduċa assorbiment globali li kien 7-11% akbar, iżda b'rati komparabbli ta' reħi tal-prodott mediċinali.
English: Race - White - Black - Asian - Other
Maltese: Razza - Bojod - Suwed - Asjatiċi - Oħrajn
English: NAME OF THE MEDICINAL PRODUCT Viramune 50 mg/5 ml oral suspension nevirapine
Maltese: Viramune 50 mg/5 ml suspensjoni orali nevirapine
English: Median age was 34 years and about 64 % were male patients, median CD4 cell count was 170 and 190 cells per mm
Maltese: L-età medjana kienet ta' 34 sena u madwar 64% tal-pazjenti kienu rġiel, l-għadd medjan ta' CD4 kien ta' 170 u 190 ċellula għal kull mm
English: Each prolonged-release tablet contains 400 mg of lactose (as monohydrate).
Maltese: Kull pillola li terħi l-mediċina bil-mod fiha 400 mg ta' lactose (bħala monohydrate).
English: At 24 weeks after randomisation in the TRANxITION study, 92.6 % and 93.6 % of patients receiving Viramune 200 mg immediate-release twice daily or Viramune 400 mg prolonged-release once daily, respectively, continued to have HIV-1 RNA < 50 copies/ml.
Maltese: Wara 24 ġimgħa wara l-każwalità fl-istudju TRANxITION , 92.6% u 93.6% tal-pazjenti li kienu qed jirċievu Viramune 200 mg li jerħi l-mediċina fil-pront darbtejn kuljum jew Viramune 400 mg li jerħi l-mediċina bil-mod darba kuljum, rispettivament, komplew ikollhom HIV-1 RNA < 50 kopji/ml.
English: Long-term efficacy appears to be most likely in patients whose nevirapine trough levels exceed 3.5 µg/ml.
Maltese: Effikaċja fit-tul tidher l-aktar f'pazjenti li l-anqas livelli ta' nevirapine huma aktar minn 3.5 µg/ml.
English: It is not recommended to coadminister ketoconazole and Viramune (see section 4.4).
Maltese: Mhux rakkomandat li ketoconazole u Viramune jingħataw flimkien (ara sezzjoni 4.4).
English: EU/1/97/055/009 [90 prolonged-release]
Maltese: EU/1/97/055/009 (90 pillola, folja)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of oral suspension contains 10 mg of nevirapine (as hemihydrate)
Maltese: Kull ml ta' suspensjoni orali fih 10 mg nevirapine (bħala hemihydrate)
English: Viramune prolonged-release tablets dose (mg)
Maltese: Doża ta' Viramune pilloli li jerħu lmediċina bil-mod (mg)
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: Viramune should be combined with at least two additional antiretroviral agents.
Maltese: Viramune għandu jiġi kkombinat ma' mill-anqas żewġ sustanzi anti-retrovirali addizzjonali.
English: Each prolonged-release tablet contains 100 mg of lactose (as monohydrate).
Maltese: Kull pillola li terħi l-mediċina bil-mod fiha 100 mg ta' lactose (bħala monohydrate).
English: Viramune is indicated for the treatment of HIV-1 infected adults, adolescents, and children of any age.
Maltese: Viramune hu indikat għall-kura ta' adulti, adolexxenti, u tfal ta' kull età infettati bl-HIV-1.
English: Viramune is also available in liquid form as an oral suspension.
Maltese: Viramune jiġi wkoll bħala suspensjoni orali.
English: The observed geometric mean ratios of Viramune prolonged-release to Viramune immediate-release were ~90 % for Cmin,ss and AUCss with 90% confidence intervals within 80 %-125 %; the ratio for Cmax,ss was lower and consistent with a once-daily prolonged-release dosage form.
Maltese: Il-medja tal-proporzjonijiet ġeometriċi osservati ta' Viramune li jerħi l-mediċina bil-mod imqabbla ma' Viramune li jerħi lmediċina fil-pront kienu ~90% għal Cmin,ss u AUCss b'intervalli ta' kunfidenza ta' 90% fil-medda 80%125%; il-proporzjon għal Cmax,ss kienet inqas u konsistenti mal-forma ta' dożaġġ li jerħi l-mediċina bilmod darba kuljum.
English: Nevirapine pharmacokinetics in HIV-1 infected adults does not appear to change with age (range 19-68 years) or race (Black, Hispanic, or Caucasian).
Maltese: Il-farmakokinetika ta' nevirapine f'adulti b'HIV-1 ma tidhirx li tinbidel bl-età (fuq medda ta' 19-68 snin) jew razza (Suwed, Ispaniċi, jew Kawkażi).
English: This is due to induction of medicinal product metabolism enzymes and/or transport proteins by St. John's Wort.
Maltese: Dan minħabba l-induzzjoni minn enżimi tal-metaboliżmu tal-prodott mediċinali u/jew proteini tat-transport minn St.
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 idrossilatati ikkonġugati ma' glucuronide.
English: The side effects described below have been experienced by patients given Viramune:
Maltese: L-effetti sekondarji deskritti hawn taħt inħassu minn pazjenti li ngħataw Viramune:
English: Viramune oral suspension contains 150 mg sucrose per ml.
Maltese: Is-suspensjoni orali Viramune fiha 150 mg ta' sukrożju f'kull ml.
English: 3 for men.
Maltese: 3 u 197
English: Other published data support these conclusions.
Maltese: Informazzjoni oħra pubblikata taqbel ma' dawn il-konklużjonijiet.
English: Plasma trough concentrations of boceprevir were decreased when administered with an NNRTI with a similar metabolic pathway as nevirapine.
Maltese: L-inqas livelli talkonċentrazzjonijiet fil-plażma ta' boceprevir tnaqqsu meta ngħataw ma' NNRTI b'passaġġ metaboliku simili bħal nevirapine.
English: Viramune belongs to a group of medicines called antiretrovirals, used in the treatment of Human Immunodeficiency Virus (HIV-1) infection.
Maltese: Viramune jappartjeni għal grupp ta' mediċini li jissejħu antiretrovirali, użati fit-trattament ta' infezzjonijiet ikkaġunati mill-Vajrus ta' Immunodefiċjenza Umana (HIV-1).
English: - The other ingredients are: carbomer, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sorbitol, sucrose, polysorbate 80, sodium hydroxide and water.
Maltese: - Is-sustanzi mhux attivi l-oħra huma: - carbomer, - methyl parahydroxybenzoate, - propyl parahydroxybenzoate, - sorbitol, - sukrożju, - polysorbate 80, - sodium hydroxide u
English: Nervous system disorders Common headache
Maltese: Disturbi fis-sistema nervuża Komuni uġigħ ta' ras
English: Following intravenous administration to healthy adults, the volume of distribution (Vdss) of nevirapine was 1.21  0.09 l/kg, suggesting that nevirapine is widely distributed in humans.
Maltese: Wara injezzjoni ġol-vina f'adulti b'saħħithom, il-volum ta' distribuzzjoni (Vdss) ta' nevirapine kien ta' 1.21  0.09 l/kg.
English: Data concerning the pharmacokinetics of nevirapine have 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: 1368) li saret fl-Afrika t'Isfel li tinvolvi 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: Black patients (n=80/group) in study 1100.1486 showed approximately 30 % higher trough concentrations than Caucasian patients (250-325 patients/group) in both the Viramune immediate-release and Viramune prolonged-release treatment groups over 48 weeks of treatment at 400 mg/day.
Maltese: Pazjenti suwed (n=80/grupp) fi studju 1100.1486 urew konċentrazzjonijiet minimi li bejn wieħed u ieħor kienu 30% ogħla minn dawk ta' pazjenti Kawkasi (250-325 pazjent/grupp) kemm fil-gruppi tal-kura b'Viramune li jerħi l-mediċina fil-pront kif ukoll b'Viramune li jerħi l-mediċina bilmod fuq 48 ġimgħa ta' kura b'doża ta' 400 mg/kuljum.
English: Viramune is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infected adults, adolescents, and children three years and above and able to swallow tablets (see section 4.2).
Maltese: Viramune huwa indikat biex jingħata flimkien ma' prodotti mediċinali anti-retrovirali oħra għattrattament ta' adulti, adolexxenti u tfal ta' tliet snin u aktar u li kapaċi jibilgħu l-pilloli (ara sezzjoni 4.2).
English: INFORMATION IN BRAILLE viramune 100 mg prolonged-release tablets
Maltese: INFORMAZZJONI BIL-BRAILLE viramune 100 mg pilloli li jerħu l-mediċina bil-mod
English: If liver function abnormalities recur, nevirapine should be permanently discontinued.
Maltese: Jekk jirriżulta li l-funzjoni tal-fwied tkun abnormali, nevirapine għandu jitwaqqaf b'mod permanenti.
English: Fatal cases of SJS, TEN and drug reaction with eosinophilia and systemic symptoms have been reported.
Maltese: Ġew rapportati wkoll każijiet fatali ta' SJS, TEN u reazzjoni minħabba l-mediċina b'eosinofilija u sintomi sistemiċi.
English: Results of a 48-week analysis of the South African study BI 1100.1368 confirmed that the 4/7 mg/kg and 150 mg/m2 nevirapine dose groups were well tolerated and effective in treating antiretroviral naive paediatric patients.
Maltese: 1368 ikkonfermaw li filgruppi li kienu qed jingħataw doża ta' nevirapine ta' 4/7 mg/kg u 150 mg/m2, il-mediċina kienet ittollerata tajjeb u kienet effettiva fil-kura ta' pazjenti pedjatriċi li qatt ma kienu kkurati b'mediċini antiretrovirali fil-passat.
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: L-analiżi ġenotipika ta' kampjuni minn pazjenti inkonsapevoli għal antiretrovirali li esperjenzaw falliment viroloġiku (n=71) li qegħdin fuq nevirapine darba kuljum (n=25) jew darbtejn kuljum (n=46) 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: Nevirapine AUC  1.29 (1.19-1.40) Nevirapine Cmin  1.34 (1.21-1.49) Nevirapine Cmax  1.25 (1.14-1.37)
Maltese: Nevirapine Cmin  1.34 (1.21-1.49) Nevirapine Cmax  1.25 (1.14-1.37)
English: Since neither body weight nor Body Mass Index (BMI) had influence on the clearance of nevirapine, the effect of gender cannot be explained by body size.
Maltese: Peress li la l-piż tal-ġisem u lanqas il-Body Mass Index (BMI) ma kellhom influwenza fuq ir-rata ta' l-eliminazzjoni ta' nevirapine, l-effett tal-ġens ma jistax jiġi spjegat bid-daqs tal-ġisem.
English: The dose for adults is 20 ml (200 mg) once a day for the first 14 days of treatment (”lead in” period).
Maltese: Id-doża għall-adulti hi ta' 20 ml (200 mg) darba kuljum għall-ewwel 14-il jum ta' trattament (perijodu “inizjali”).
English: HIV-1 isolates with reduced susceptibility (100-250-fold) to nevirapine emerge in cell culture.
Maltese: Kampjuni ta' HIV-1 b'suxxetibilità mnaqqsa (100-250 darba) għal nevirapine tfaċċaw fil-koltura ta' ċelluli.
English: Most of the experience with Viramune is in combination with nucleoside reverse transcriptase inhibitors (NRTIs).
Maltese: L-aktar esperjenza miksuba b'Viramune hija meta tintuża ma' impedituri ta' l-enzima nucleoside reverse transcriptase (NRTI's).
English: Viramune oral suspension contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.
Maltese: Is-suspensjoni orali Viramune fiha methyl parahydroxybenzoate u propyl parahydroxybenzoate.
English: The observed pharmacokinetic difference between the 50 mg and 100 mg Viramune prolonged-release tablets is not clinically relevant, and the 50 mg prolonged-release tablet can be used as an alternative to the slightly larger 100 mg tablet.
Maltese: Id-differenza farmakokinetika osservata bejn il-pilloli Viramune ta' 50 mg u 100 mg li jerħu l-mediċina bil-mod mhijiex klinikament rilevanti, u l-pillola ta' 50 mg li terħi l-mediċina bil-mod tista' tintuża bħala alternattiva għall-pillola ftit akbar ta' 100 mg.
English: ANTITHROMBOTICS Warfarin
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: INFORMATION IN BRAILLE Viramune 200 mg
Maltese: Viramune 200 mg
English: Uncommon Stevens-Johnson Syndrome/toxic epidermal necrolysis (which may be fatal) (0.2 %), angioedema, urticaria
Maltese: Sindromu ta' Stevens Johnson/ nekrolisi epidermali tossika (li tista' tkun fatali) (0.2%), anġjoedema, urtikarja Disturbi muskolu-skeletriċi u tat-tessuti konnettivi
English: Renal impairment: The single-dose pharmacokinetics of nevirapine has been compared in 23 patients with either mild (50  CLcr  80 ml/min), moderate (30  CLcr  50 ml/min) or severe renal dysfunction (CLcr  30 ml/min), renal impairment or end-stage renal disease (ESRD) requiring dialysis, and 8 patients with normal renal function (CLcr  80 ml/min).
Maltese: Il-farmakokinetika ta' doża waħda ġiet mqabbla f'23 pazjent li wħud kellhom indeboliment fil-kliewi ħafif (50  CLcr  80 ml/min), moderat (30  CLcr  50 ml/min) jew qawwi (CLcr  30 ml/min), jew f'pazjenti morda serjament bil-kliewi li ħtieġu dijaliżi.
English: Uncommon Stevens-Johnson Syndrome/toxic epidermal necrolysis (which may be fatal) (0.6 %), angioedema, urticaria
Maltese: Sindrome ta' Stevens-Johnson/nekrolisi epidermali tossika (li tista' tkun fatali) (0.6%), anġjodema, urtikarja Disturbi muskolu-skeletriċi u tat-tessuti konnettivi
English: At 12 months, the Kaplan-Meier estimates of the likelihood of reaching the endpoint were 10 % in the Viramune group, 6 % in the efavirenz group, and 13 percent in the abacavir group (P=0.10 according to an intention-to-treat analysis).
Maltese: Wara 12-il xahar l-istimi ta' Kaplan-Meier dwar il-probabilità li jintlaħaq il-punt aħħari ta' riferiment kienu 10% għal grupp ta' Viramune, 6% għal grupp ta' efavirenz, u 13% fil-grupp ta' abacavir (P=0.10 skont l-analiżi għal ħsieb ta' kura).
English: The interaction between nevirapine and the antithrombotic agent warfarin is complex, with the potential for both increases and decreases in coagulation time when used concomitantly.
Maltese: L-interazzjoni bejn nevirapine u laġent antitrombotiku warfarin hi kumplessa, bil-potenzjal kemm ta' żidiet kif ukoll ta' tnaqqis fil-ħin talkoagulazzjoni meta jintużaw flimkien.
English: Viramune prolonged-release n=505
Maltese: Viramune li jerħi l-mediċina bil-mod n=505
English: Calculation of the volume of Viramune oral suspension (50 mg/5 ml) required for paediatric dosing on a body surface basis of 150 mg/m
Maltese: Kalkulazzjoni tal-volum ta' Viramune suspensjoni orali (50 mg/5 ml) meħtieġa għal doża lil pazjenti pedjatriċi fuq bażi ta' superfiċje tal-ġisem ta' 150 mg/m
English: Following multiple doses, nevirapine peak concentrations appear to increase linearly in the dose range of 200 to 400 mg/day.
Maltese: Wara dożi multipli, l-ogħla konċentrazzjoniet ta' nevirapine jidhru li jiżdiedu b'mod lineari meta doża tkun minn 200 sa 400 mg/kuljum.
English: Viramune is also available as tablets.
Maltese: Viramune jiġi wkoll bħala pilloli.
English: Accordingly, as anaemia, granulocytopenia, anaphylactic reaction, jaundice, Stevens-Johnson Syndrome/toxic epidermal necrolysis (which may be fatal), angioedema, decreased blood phosphorus and increased blood pressure during maintenance phase with Viramune prolonged-release tablets were not seen in study 1100.1486 the frequency category was estimated from a statistical calculation based on the total number of patients exposed to nevirapine prolonged-release in the maintenance phase of the randomised controlled clinical study 1100.1486 (n= 505).
Maltese: Għaldaqstant, billi anemija, granuloċitopenija, reazzjoni anafilattika, suffejra, Sindromu ta' StevensJohnson/nekrolisi epidermali tossika (li tista' tkun fatali), anġjoedema, tnaqqis fil-livell ta' phosphorus fid-demm u żieda fil-pressjoni tad-demm matul il-fażi ta' manteniment b'Viramune pilloli li jerħu l-mediċina bil-mod ma ġewx osservati fi studju 1100.
English: It is not recommended to coadminister boceprevir and Viramune (see section 4.4).
Maltese: Mhuwiex rakkomandat li tagħti flimkien boceprevir u Viramune (ara sezzjoni 4.4).
English: Clarithromycin exposure was significantly decreased, 14-OH metabolite exposure increased.
Maltese: L-espożizzjoni ta' clarithromycin tnaqqset b'mod sinifikanti, l espożizzjoni għal metabolit 14-OH żdiedet.
English: Methyl and propyl parahydroxybenzoates: Viramune oral suspension contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reaction (possibly delayed).
Maltese: Is-suspensjoni orali Viramune fiha methyl parahydroxybenzoate u propyl parahydroxybenzoate, li jistgħu jikkawżaw reazzjonijiet allerġiċi serji (possibilment ittardjati),
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 ntlaħqu f'4 sigħat wara li ngħatat doża waħda ta' 200 mg.