FrancophonIA/ELRC3.0 huggingface dataset:
English: Gastrointestinal disorders Common nausea, vomiting, abdominal pain, diarrhoea Hepatobiliary disorders Common hepatitis (including severe and life-threatening hepatotoxicity) (1.9%) Uncommon jaundice
Maltese: Komuni uġigħ addominali, nawseja, rimettar, dijarea Disturbi fil-fwied u fil-marrara Komuni epatite (li tinkludi epatotossiċità severa ta' periklu għall-ħajja) (1.6%)
English: NAME OF THE MEDICINAL PRODUCT Viramune 50 mg/5 ml oral suspension
Maltese: Viramune 50 mg/5 ml suspensjoni orali
English: The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing (see section 5.1).
Maltese: L-għażla ta' terapija sussegwenti wara Viramune għandha tkun ibbażżata fuq esperjenza klinika u testijiet ta' reżistenza (ara sezzjoni 5.1).
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 trattati 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: Results of in vitro studies showed a weak antagonism of nevirapine by ribavirin (see section 5.1), this has not been confirmed in clinical trials and reduced efficacy is not expected.
Maltese: Riżultati ta' studji in vitro wrew antagoniżmu dgħajjef ta' nevirapine minn ribavirin (ara sezzjoni 5.1), dan ma ġiex ikkonfermat fil-provi kliniċi, u tnaqqis fl-effikaċja mhuwiex mistenni.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia.
Maltese: Eżempji rilevanti huma cytomegalovajrus retinitis, infezzjonijiet mikobatterjoloġiċi ġenerali jew/u iffokati u pnewmonja Pneumocystis jirocevii.
English: Serum levels of nevirapine can be reduced by concomitant use of the herbal preparation St. John's Wort (Hypericum perforatum).
Maltese: John's Wort (Hypericum perforatum).
English: Readministration to patients who previously had ASAT or ALAT > 5 ULN during nevirapine therapy and had recurrence of liver function abnormalities upon readministration of nevirapine (see section
Maltese: ULN waqt terapija b'nevirapine u li kellhom mill-ġdid abnormalitàjiet fil-funzjoni tal-fwied meta reġgħu ngħataw nevirapine (ara sezzjoni
English: By stopping reverse transcriptase from working, Viramune helps control HIV-1 infection.
Maltese: Meta jwaqqaf reverse transcriptase milli jaħdem, Viramune jgħin biex jikkontrolla l-infezzjoni ta' HIV-1.
English: Adefovir did not influence any of the common CYP isoforms known to be involved in human drug metabolism and is excreted renally.
Maltese: Adefovir ma influwenzax kwalunkwe mill-isoformi komuni ta' CYP magħrufa li huma involuti filmetaboliżmu tal-mediċina talbniedem u jiġi eliminat mill-kliewi.
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 anti-retrovirali kombinata, huma aktar predisposti għal reazzjonijiet qawwija jew fatali tal-fwied.
English: Investigations
Maltese: IMPEDITURI
English: Results of in vitro studies showed a weak antagonism of nevirapine by adefovir (see section 5.1), this has not been confirmed in clinical trials and reduced efficacy is not expected.
Maltese: Riżultati ta' studji in vitro wrew antagoniżmu dgħajjef ta' nevirapine minn adefovir (ara sezzjoni 5.1), dan ma ġiex ikkonfermat fil-provi kliniċi, u tnaqqis fl-effikaċja mhuwiex mistenni.
English: Nevirapine concentrations in human cerebrospinal fluid (n = 6) were 45 % ( 5 %) of the concentrations in plasma; this ratio is approximately equal to the fraction not bound to plasma protein.
Maltese: Il-konċentrazzjoni ta' nevirapine fil-fluwidu ċerebrospinali tal-bniedem (n = 6) kien 45 % (5 %) tal-konċentrazzjonijiet filplażma; dan l-ammont huwa kważi l-istess ta' l-ammont tal-frazzjoni li mhux mwaħħal ma' proteini tal-plażma.
English: An increased risk was observed in men with detectable HIV-1 RNA in plasma and CD4 counts > 400 cells/mm
Maltese: Riskju akbar kien osservat f'irġiel b'HIV-1 RNA li jista' tiġi osservat fil-plażma u li kellhom l-għadd ta' ċelluli CD4 >400 ċelluli/mm
English: Due to the metabolic pathway of raltegravir no interaction is expected.
Maltese: Minħabba l-passaġġ metaboliku ta' raltegravir mhux mistenni li jkun hemm interazzjonijiet.
English: PHARMACEUTICAL FORM AND CONTENTS Treatment initiation pack containing 14 tablets
Maltese: U KONTENUT Pakkett tal-bidu tat-trattament li fih 14-il pillola
English: Rare (may affect up to 1 in 1000 people): - sudden and intense inflammation of the liver (fulminant hepatitis) - drug reaction with systemic symptoms (drug reaction with eosinophilia and systemic symptoms)
Maltese: Rari (jistgħu jaffettwaw sa 1 minn kull 1000 persuna): - infjammazzjoni tal-fwied f'daqqa u intensa (epatite fulminanti) - reazzjoni minħabba l-mediċina b'sintomi sistemiċi (reazzjoni minħabba l-mediċina b'eosinofilija u sintomi sistemiċi)
English: Elderly Nevirapine has not been specifically investigated in patients over the age of 65.
Maltese: Anzjani Nevirapine ma ġiex speċifikament studjat f'pazjenti 'l fuq minn 65 sena.
English: Genotypic analysis was performed on isolates from 86 antiretroviral naïve patients who discontinued the VERxVE study (1100.1486) after experiencing virologic failure (rebound, partial response) or due to an adverse event or who had transient increase in viral load during the course of the study.
Maltese: Analiżi ġenotipika twettqet fuq iżolati minn 86 pazjenti li qatt ma rċivew kura antiretrovirali filpassat, li ma komplewx bl-istudju VERxVE (1100.
English: Each tablet contains less than 1 mmol sodium (23 mg), that is to say essentially ‘sodium-free'.
Maltese: Kull pillola fiha anqas minn 1 mmol sodium (23 mg), jiġifieri essenzjalment ‘ħielsa mis-sodium'.
English: Patients were enrolled with CD4 counts <250 cells/mm
Maltese: Il-pazjenti kienu rreġistrati b'għadd CD4 ta' <250 ċelluli/mm
English: Cross-resistance between nevirapine and either HIV protease inhibitors, HIV integrase inhibitors or HIV entry inhibitors is unlikely because the enzyme targets involved are different.
Maltese: Reżistenza inkroċjata bejn nevirapine u jew impedituri tal-protease bl-HIV, impedituri tal integrase bl-HIV, jew impedituri tad-dħul bl-HIV mhix probabbli peress li l-miri enżimatiċi involuti huma differenti.
English: This difference is not considered clinically relevant.
Maltese: Din id-differenza mhix ikkonsidrata klinikament rilevanti.
English: The mean peak plasma concentration of nevirapine was 2,060 ng/ml measured at a mean 24.5 hours after administration of 400 mg Viramune prolongedrelease tablets.
Maltese: Il-medja tal-konċentrazzjoni massima ta' nevirapine fil-plażma kienet ta' 2,060 ng/ml, imkejla bħala medja ta' 24.5 sigħat wara l-għoti ta' 400 mg Viramune pilloli li jerħu l-mediċina bilmod.
English: Renal impairment: The single-dose pharmacokinetics of nevirapine immediate-release 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 ta' nevirapine li jerħi l-mediċina fil-pront ġiet 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), ew f'pazjenti morda serjament bil kliewi li ħtieġu dijaliżi.
English: Lactose: Viramune tablets contain 636 mg of lactose per maximum recommended daily dose.
Maltese: Il-pilloli Viramune fihom 636 mg ta' lattosju għal kull doża massima rakkomandata ta' kuljum.
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal fruttożju, assorbiment ħażin ta' glukozju-galattozju jew insuffiċjenza ta' sukrozju-isomaltase m'għandhomx jieħdu din il-mediċina.
English: The patients studied were receiving antiretroviral therapy containing Viramune 200 mg immediaterelease tablets 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 Viramune 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: The side effects described below have been experienced by patients given Viramune 200 mg tablets during the 14 day lead-in phase:
Maltese: L-effetti sekondarji deskritti hawn taħt inħassu minn pazjenti li ngħataw pilloli Viramune ta' 200 mg matul il-perjodu ta' introduzzjoni ta' 14-il jum:
English: • have a body surface area of 1.17 m2 or above according to the Mosteller formula.
Maltese: • ikollhom erja ta' superfiċje tal-ġisem ta' 1.17 m2 jew aktar skont il-formula ta' Mosteller.
English: The following patients are at increased risk of developing liver problems: - women - infected with hepatitis B or C - abnormal liver function tests - 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: Il-pazjenti li ġejjin jinsabu f'riskju ogħla li jiżviluppaw problemi tal-fwied: - nisa - persuni infettati b'epatite B jew Ċ - testijiet abnormali ta' kif qed jaħdem il-fwied - 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: In this open-label study, 443 patients already on an antiviral regimen containing Viramune 200 mg immediate-release twice daily with HIV-1 RNA < 50 copies/ml were randomised in a 2:1 ratio to Viramune 400 mg prolongedrelease once daily or Viramune 200 mg immediate-release twice daily.
Maltese: F'dan l-istudju open-label, 443 pazjent li diġà kienu qegħdin fuq kors antivirali 200 mg li jerħi lmediċina fil-pront darbtejn kuljum b'HIV-1 RNA < 50 kopji/ml intgħażlu b'mod każwali fi proporzjon ta' 2:1 għal Viramune 400 mg li jerħi l-mediċina bil-mod darba kuljum jew Viramune 200 mg li jerħi l-mediċina fil-pront darbtejn kuljum.
English: Autoinduction also results in a corresponding decrease in the terminal phase half-life of nevirapine in plasma from approximately 45 hours (single dose) to approximately 25-30 hours following multiple dosing with 200-400 mg/day.
Maltese: Minħabba din l-eliminazzjoni jkun hemm tnaqqis blistess mod fl-aħħar fażi ta' half-life ta' nevirapine fil-plażma, minn madwar 45 siegħa (doża waħda) sa madwar 25-30 siegħa wara dożi multipli ta' 200-400 mg/kuljum.
English: One side is marked with the code “54 193”, with a single bisect separating the “54” and “193”.
Maltese: Naħa waħda hi mmarkata bil-kodiċi “54 193”, b'sinjal wieħed li jissepara n-numri “54” u “193”.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 100 mg of nevirapine (as anhydrous).
Maltese: Kull pillola li terħi l-mediċina bil-mod fiha 100 mg ta' nevirapine (bħala anhydrous).
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 fir-riskju ta' tossiċità bbażat fuq limiti tal-għadd ta' CD4 ma ġietx osservata f'pazjenti b'ammont virali fil-plażma li ma jistax jiġi osservat (i.e. < 50 kopja/ml).
English: In a single dose pharmacokinetic study of 200 mg Viramune immediate-release tablets in 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 epatiku ħafif u moderat (Child-Pugh A, n=6; Child-Pugh B, n=4) żieda sinifikanti flAUC ta' nevirapine kienet osservata f'pazjent Child-Pugh B b'axxite li jissuġerixxi li pazjenti b'funzjoni epatika u axxite li sejrin għal agħar jistgħu jkunu f'riskju li qed jakkumulaw nevirapine fissistema taċ-ċirkolazzjoni.
English: Interferons have no known effect on CYP 3A4 or 2B6.
Maltese: Interferons m'għandhom l-ebda effett magħruf fuq CYP 3A4 jew 2B6.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 400 mg of nevirapine (as anhydrous).
Maltese: Kull pillola li terħi l-mediċina bil-mod fiha 400 mg ta' nevirapine (bħala anhydrous).
English: anaphylactic reaction, angioedema, urticaria) Uncommon anaphylactic reaction Rare drug reaction with eosinophilia and systemic symptoms Nervous system disorders
Maltese: Rari reazzjoni minħabba l-mediċina b'eosinofilija u sintomi sistemiċi Disturbi fis-sistema nervuża
English: All patients received tenofovir + emtricitabine as background therapy.
Maltese: Il-pazjenti kollha rċivew tenofovir + emtricitabine bħala terapija fl-isfond.
English: Viramune oral suspension contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
Maltese: Is-suspensjoni orali Viramune fiha anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħielsa mis-sodium'
English: Nevirapine has been shown to be an inducer of hepatic cytochrome P450 metabolic enzymes.
Maltese: Instab li nevirapine jistimula l-produzzjoni ta' enzimi metaboliċi tas-sistema P450 li tinsab fil-fwied.
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 vixxerali.
English: Rare (may affect up to 1 in 1000 people): - inflammation of the liver (hepatitis) - decreased numbers of red blood cells (anaemia)
Maltese: Rari (jistgħu jaffettwaw sa 1 minn kull 1000 persuna): - infjammazzjoni tal-fwied (epatite) - tnaqqis fin-numru ta' ċelluli tad-demm ħomor (anemija)
English: Uncommon pyrexia Investigations Common liver function test abnormal (alanine aminotransferase increased; transaminases increased; aspartate aminotransferase increased; gamma-glutamyltransferase increased; hepatic enzyme increased; hypertransaminasaemia), blood phosphorus decreased, blood pressure increased
Maltese: Investigazzjonijiet Komuni test tal-funzjoni tal-fwied b'riżultat anormali (żieda f'alanine aminotransferase; żieda fi transaminases; żieda f'aspartate aminotransferase; żieda f'gammaglutamyltransferase; żieda fl-enzimi tal-fwied; ipertransaminasemnija)
English: 3 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: 3 f'irġiel adulti) fil-bidu tat-terapija b'nevirapine huma assoċjati ma' riskju akbar ta' reazzjonijiet avversi fil-fwied jekk il-pazjent ikollu HIV-1 RNA li tkun tista' tiġi osservata fil-plażma - i.e. konċentrazzjoni ta' 50 kopja/ml - fil-bidu tal-kura b'nevirapine.
English: Nevirapine must not be administered to patients with pretreatment ASAT or ALAT > 5 ULN until baseline ASAT/ALAT are stabilised < 5 ULN (see section
Maltese: ASAT/ALAT tiġi stabbli < 5 ULN (ara sezzjoni 4.3).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/055/001 [60 tablets]
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/97/055/001 [60 pillola]
English: One side is embossed with the code “54 193”, with a single bisect separating the “54” and “193”.
Maltese: Hemm ukoll xaqq li jaqsam il-pillola bejn l-ewwel parti tal-kodiċi, “54” u l-parti l-oħra, “193”.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/055/001 (60 tablets) EU/1/97/055/003 (120 tablets) EU/1/97/055/004 (14 tablets)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/97/055/001 (60 pillola)
English: In the case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
Maltese: Jekk fl-istess waqt tkun qed tingħata terapija antivirali kontra l-epatite B jew Ċ, jekk jogħġbok ara l-informazzjoni rilevanti ta' dawn mediċini.
English: Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Maltese: Pazjenti li diġà jsofru minn mard tal-fwied, bħal epatite attiva kronika, għandhom frekwenza akbar ta' abnormalitajiet fil-fwied meta jingħataw terapija antiretrovirali kkombinata.
English: Viramune 100 mg prolonged-release tablets are yellow, round and biconvex.
Maltese: Viramune 100 mg pilloli li jerħu l-mediċina bil-mod huma sofor, tondi u bikonvessi.
English: Very common (may affect more than 1 in 10 people): - rash
Maltese: Komuni ħafna (jistgħu jaffettwaw aktar minn 1 minn kull 10 persuni): - raxx
English: It is not recommended to coadminister efavirenz and Viramune (see section 4.4), because of additive toxicity and no benefit in terms of efficacy over either NNRTI alone (for results of 2NN study, see section 5.1 Viramune immediate-release formulations).
Maltese: Mhux rakkomandat li efavirenz u Viramune, jingħataw flimkien (ara sezzjoni 4.4), minħabba tossiċità addittiva u ebda siwi f'termini tal effikaċja ta' ebda mill-NNRTI waħedhom (għar-riżultati tal-istudju 2NN, ara sezzjoni 5.1).
English: It is not recommended to coadminister rifampicin and Viramune (see section 4.4).
Maltese: Mhux rakkomandat li rifampicin jingħata flimkien ma' Viramune (are sezzjoni 4.4).
English: Viramune 100 mg prolonged-release tablets nevirapine
Maltese: Viramune 100 mg pilloli li jerħu l-mediċina bil-mod nevirapine
English: In single dose, parallel group bioavailability studies (studies 1100.1517 and 1100.1531), the Viramune 50 and 100 mg prolonged-release tablets exhibited extended release characteristics of prolonged absorption and lower maximal concentrations, similar to the findings when a 400 mg prolongedrelease tablet was compared to the Viramune immediate-release 200 mg tablet.
Maltese: 1531), il-pilloli Viramune ta' 50 u 100 mg li jerħu l-mediċina bil-mod urew karatteristiċi ta' reħi estiż ta' assorbiment fit-tul u konċentrazzjonijiet massimi iktar baxxi, u dan kien simili għar-riżultati meta pillola ta' 400 mg pillola li terħi l-mediċina bil-mod tqabblet mal-pillola Viramune 200 mg li terħi l-mediċina fil-pront.
English: Viramune 400 mg prolonged-release tablets nevirapine
Maltese: Viramune 400 mg pilloli li jerħu l-mediċina bil-mod nevirapine
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) - decreased numbers of red blood cells (anaemia) - decreased numbers of white blood cells (granulocytopenia) - yellow skin (jaundice) - hives (urticaria) - fluid under the skin (angioneurotic oedema) - muscle pain (myalgia) - joint pain (arthralgia) - decreased blood phosphorus - increased blood pressure
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) - tnaqqis fin-numru ta' ċelluli tad-demm ħomor (anemija) - tnaqqis fin-numru ta' ċelluli tad-demm bojod (granuloċitopenija) - ġilda safranija (suffejra) - ħorriqija (urtikarja) - fluwidu taħt il-ġilda (edema anġjonewrotika) - uġigħ fil-muskoli (mijalġja) - uġigħ fil-gogi (artralġja) - tnaqqis tal-phosphorus fid-demm - żieda fil-pressjoni tad-demm
English: Patients with severe hepatic impairment (Child-Pugh C) or pre-treatment ASAT or ALAT > 5 ULN until baseline ASAT/ALAT are stabilised < 5 ULN
Maltese: Pazjenti li għandhom indeboliment serju tal-fwied (Child-Pugh C), jew 'l ASAT jew ALAT > 5
English: The nevirapine twice daily regimen and the efavirenz regimen were not significantly different (p= 0.091) in terms of efficacy as measured by treatment failure, or any component of treatment failure including virological failure.
Maltese: Il-programm ta' kura ta' nevirapine li jingħata darbtejn kuljum u l-programm ta' kura ta' efivarenz ma kinux sinifikament differenti (p=0.091) f'termini ta' effikaċja kif imkejjel minn falliment ta' trattament, jew xi komponenti għal falliment ta' trattament li jinkludi falliment viroloġiku.
English: Viramune prolonged-release
Maltese: Reazzjonijiet tal-ġilda
English: In the multinational 2NN study with Viramune immediate-release, a population pharmacokinetic substudy of 1077 patients was performed that included 391 females.
Maltese: Fl-istudju multinazzjonali 2NN b'Viramune li jerħi l-mediċina fil-pront, sar sottostudju farmakokinetiku ta' popolazzjoni ta' 1077 li kien jinkludi 391 mara.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/055/006
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/97/055/006
English: The effects of gender on the pharmacokinetics of Viramune prolonged-release have been investigated in study 1100.1486.
Maltese: L-effetti tas-sess fuq il-farmakokinetika ta' Viramune li jerħi l-mediċina bil-mod ġew investigati fi studju 1100.
English: The ingested dose was 40 times the recommended dose of 2 mg/kg/day.
Maltese: Id-doża li nbelgħet kienet ta' 40 darba tad-doża rakkomandata ta' 2 mg/kg/kuljum.
English: As granulocytopenia, drug reaction with eosinophilia and systemic symptoms, anaphylactic reaction, jaundice, hepatitis fulminant (which may be fatal), urticaria, decreased blood phosphorus and increased blood pressure during the lead-in phase with Viramune immediate release 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 immediate-release in the lead-in phase of the randomised controlled clinical study 1100.1486 (n= 1,068).
Maltese: Billi granuloċitopenija, reazzjoni minħabba l-mediċina b'eosinofilija u sintomi sistematiċi, reazzjoni anafilattika, suffejra, epatite fulminanti (li tista' tkun fatali), urtikarja, tnaqqis tal-phosphorus fid-demm u żieda fil-pressjoni tad-demm fil-perjodu ta' introduzzjoni b'Viramune li jerħi l-mediċina fil-pront ma ġewx osservati fi studju 1100.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 5 February 1998
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 5 ta' Frar 1998