qanastek/EMEA-V3 huggingface dataset:
Rashes are usually mild to moderate, maculopapular erythematous cutaneous eruptions, with or without pruritus, located on the trunk, face and extremities.
Ir- raxxijiet huma normalment minn ħfief sa moderati, li jikkonsisti minn infafet kutaneji eritematiċi makulopapulari bi jew bla prurite, u li ssibhom fit- tronk, il- wiċċ, jew fl- estremitajiet tal- ġisem.
Rashes occur alone or in the context of hypersensitivity reactions, characterised by rash with constitutional symptoms such as fever, arthralgia, myalgia and lympadenopathy, plus visceral involvement, such as hepatitis, eosinophilia, granulocytopenia, and renal dysfunction.
Ir- raxxijiet jiżviluppaw waħedhom, jew ma ’ reazzjoni ta 'ipersensittività fejn ikun hemm diversi sintomi mal- ġisem kollu bħal deni, artralġja, uġigħ ta' muskoli u limfadenopatija, kif ukoll problemi vixxerali, bħal epatite, eosinofilja, granuloċitopenija u problemi fil- kliewi.
Fatal cases of SJS, TEN and hypersensitivity reactions have been reported.
Ġew rapportati wkoll każijiet fatali ta ’ SJS, TEN u reazzjonijiet ta 'ipersensittività.
Hepato-biliary
40 Il- fwied u s- sistema bilarja tal- marrara
Asymptomatic elevations of GGT levels are the most frequent.
Iż- żjieda fil- GGT mingħajr sintomi oħrajn, hija l- aktar komuni.
Granulocytopenia was more frequently
Granuloċitopenija kienet osservata aktar frekwentament fit- tfal..
All of these effects subsided following discontinuation of VIRAMUNE.
Dawn l- effetti kollha telqu meta VIRAMUNE twaqqaf.
HIV-2 reverse transcriptase and eukaryotic DNA polymerases (such as human DNA polymerases α, β, γ, or δ) are not inhibited by nevirapine.
DNA polymerases α, β, γ jew δ tal- bniedem).
In vitro HIV susceptibility:
Suxxetabilità għal HIV in vitro
The in vitro antiviral activity of nevirapine has been measured in a variety of cell lines including peripheral blood mononuclear cells, monocyte derived macrophages, and lymphoblastoid cell lines.
41 L- attività antivirali ta ’ nevirapine in vitro ġiet imkejla f’ diversi razez ta ’ ċelloli li jinkludu ċelloli mononukleari ta ’ demm periferiku, monoċiti derivati minn makrofaġi, u razez ta ’ ċelloli limfoblastojdi.
Nevirapine exhibited antiviral activity in vitro against group M HIV-1 isolates from clades A, B, C, D, F, G, and H, and circulating recombinant forms (CRF), CRF01_AE, CRF02_AG and CRF12_BF (median EC50 value of 63 nM).
Nevirapine wera attività antivirali in vitro fuq kampjuni HIV minn grupp M minn clades A, B, C, D, F, G, u H u l- għamliet rikombinanti li jiċċirkolaw (CRF), CRF01_ AE, CRF02_ AG u CRF12_ BF( valur medjan ta ’ EC50 ta ’ 63 nM).
Nevirapine in combination with efavirenz exhibited a strong antagonistic anti-HIV-1 activity in vitro (see section 4.5) and was additive to antagonistic with the protease inhibitor ritonavir or the fusion inhibitor enfuvirtide. Nevirapine exhibited additive to synergistic anti-HIV-1 activity in combination with the protease inhibitors amprenavir, atazanavir, indinavir, lopinavir, nelfinavir, saquinavir and tipranavir, and the NRTIs abacavir, didanosine, emtricitabine, lamivudine, stavudine, tenofovir and zidovudine.
Nevirapine wera attività addittiva sa sinerġistika kontra l- HIV flimkien ma ’ l- inibitur ta ’ protease, amprenavir, atazanavir, indinavir, lopinavir, nelfinavir, saquinavir u tipranavir, u l- NRTIs abacavir, didanosine emtricitabine, lamivudine, stavudine, tenofovir u zidovudine.
Genotypic and phenotypic resistance was examined for patients receiving VIRAMUNE in triple and double therapy drug combination therapy, and in the non-VIRAMUNE comparative 39 group from the INCAS study.
Ir- reżistenza ġenotipika u fenotipika ġiet studjata f’ pazjenti li ħadu VIRAMUNE flimkien ma ’ aktar minn droga waħda (terapiji tripliċi jew kkombinati), filwaqt li l- grupp komparattiv fejn ma ngħatax VIRAMUNE, kien meħud minn studju INCAS.
The phenotypic resistance test performed required a minimum of 1000 copies/ ml HIV RNA in order to be able to amplify the virus.
It- test għal reżistenza fenotipika mwettaq kien jitlob mill- anqas 1000 kopja / ml HIV RNA biex il- vajrus seta 'jiġi kkupjat.
Of the three study groups, 16, 19 and 28 patients respectively had evaluable baseline isolates and subsequently remained in the study for at least 24 weeks.
Mit- tliet gruppi li ġew studjati, kien hemm 16, 19 u 28 pazjent minn kull grupp li minnhom ittieħdu kampjuni li kellhom il - linja ta ’ referenza bażi li kienet tista ’ tiġi valorizzata.
At baseline, there were five cases of phenotypic resistance to nevirapine; the IC50 values were 5 to 6.5-fold increased in three and > 100 fold in two.
Fil- linja ta 'riferenza bażi kien hemm ħames każijiet ta ’ reżistenza fenotipika għal nevirapine; il- valuri IC50 kienu minn 5 sa 6. 5 darbiet aktar fi tliet pazjenti u > 100 darba fit- tnejn l- oħra.
At 24 weeks, all available isolates recoverable from patients receiving nevirapine were resistant to this agent, while 18/ 21 (86%) patients carried such isolates at 30-60 weeks.
Dawn il- pazjenti baqgħu jiġu studjati sa mill- anqas 24 ġimgħa. Wara 24 ġimgħa, kull kampjun virali disponibbli elevat minn fuq pazjenti li kienu fuq nevirapine, wera reżistenza għal din id- droga, filwaqt li 18 minn 21 (86%) pazjenti ġarrew dan l- vajrus għal 30- 60 ġimgħa.
In 16 subjects viral suppression was below the limits of detection (< 20 copies/ ml = 14, < 400 copies/ ml = 2).
F’ 16- il suġġett, it- trażżin tal- vajrus kien anqas mill- limiti ta 'intraċċar (< 20 kopji/ ml = 14, < 400 kopji/ ml = 2).
Assuming that suppression below < 20 copies/ ml implies nevirapine susceptibility of the virus, 45% (17/ 38) of patients had virus measured or imputed to be susceptible to nevirapine.
Fuq preżunzjoni li t- trażżin < 20 kopji/ ml, jista ’ jiġi implikat li hemm suxxettibbiltà tal- vajrus għal nevirapine, 45% (17/ 38) tal- pazjenti ġew ittestjati li kellhom il - vajrus suxxettibbli għal jew attribwit lil nevirapine.
All 11 subjects receiving VIRAMUNE + zidovudine who were tested for phenotypic resistance were resistant to nevirapine by six months.
Il- 11- il pażjent kollha li ngħataw VIRAMUNE u zidovudine, analizzati għal reżistenza fenotipika, rriżultaw li kienu reżistenti għal nevirapine b ’ sitt xhur.
Zidovudine resistance emerged as more frequent after 30-60 weeks, especially in patients receiving double combination therapy.
Reżistenza għal zidovudine tfaċċat aktar frekwenti wara 30- 60 ġimgħa, b' mod speċjali fuq pazjenti li qed jirċievu terapija kombinata doppja.
Based on the increase in IC50, zidovudine resistance appeared lower in the VIRAMUNE + zidovudine + didanosine group than the other treatment groups.
Imsejjes fuq iż- żjieda f' IC50, ir- reżistenza għal zidovudine dehret aktar baxxa fil- grupp ta ’ VIRAMUNE + zidovudine + didanosine, milli fil- gruppi l- oħra.
With respect to nevirapine resistance, all isolates that were sequenced carried at least one mutation associated with resistance, the most common single changes being K103N and Y181C.
Ir- riżultati ta 'sequencing tal- kampjuni kollha wrew li mill- anqas kien hemm mutazzjoni waħda assoċjata mar- reżistenza ta' nevirapine.
Combinations of mutations were found in nine of the 12 patients observed.
L- aktar bidliet komuni f’ aċidu amminiku wieħed ikunu K103N u Y181CDis ’ minn 12- il pazjent osservat kellhom aktar minn mutazzjoni waħda.
These data from INCAS illustrate that the use of highly active drug therapies is associated with a delay in the development of antiretroviral drug resistance.
Din l- informazzjoni minn INCAS tiċċara kif terapiji b’ drogi li għandhom attività għolja huma assoċjati ma 'dewmin fl - iżvilupp ta ’ reżistenza kontra mediċina anti- retrovirali.
The clinical relevance of phenotypic and genotypic changes associated with VIRAMUNE therapy has not been established.
42 L- implikazzjoni klinika ta 'bidliet fenotipiċi u ġenotipiċi li huma assoċjati ma ’ terapija b’ VIRAMUNE ma ġietx stabbilita.
In addition to the data presented above, there exists a risk of rapid emergence of resistance to NNRTIs in case of virological failure.
Mat- tagħrif ta ’ hawn fuq, irrid jiżdied li hemm riskju li titfaċċa f’ daqqa reżistenza għal NNRTIs, f’ każ ta ’ insuffiċjenza viroloġika.
Cross-resistance Rapid emergence of HIV strains which are cross-resistant to NNRTIs has been observed in vitro.
Reżistenza inkroċjata Fil- laboratorju ġew osservati tipi ta ’ HIV li tfaċċaw malajr u għandhom reżistenza inkroċjata ma 'NNRTI in vitro.
In four patients, zidovudine-resistant isolates tested in vitro retained susceptibility to nevirapine and in six patients nevirapine-resistant isolates were susceptible to zidovudine and didanosine.
F’ kampjuni minn sitt pazjenti, li kellhom reżistenza virali għal nevirapine baqgħu suxxettibbli għal zidovudine u didanosine.
Cross-resistance between nevirapine and HIV PIs is unlikely because the enzyme targets involved are different.
Reżistenza inkroċjata bejn nevirapine u HIV PIs mhux mistennija għaliex l- enzimi bersalli involuti, huma differenti.
Some genotypic resistance data indicate that in most patients failing NNRTI viral strains express cross-resistance to the other NNRTIs.
Xi informazzjoni miksuba fuq reżistenza ġenotipika tindika li f' ħafna pazjenti fejn dawn mhux qed jaħdmu, razez virali jesprimu reżistenza inkroċjata f’ NNRTIs oħrajn.
Results from a trial (ACTG 241) evaluated triple therapy with VIRAMUNE, zidovudine and didanosine compared to zidovudine + didanosine, in 398 HIV-1 infected patients (mean baseline 153 CD4+ cells/ mm3; plasma HIV-1 RNA 4.59 log10 copies/ ml), who had received at least 6 months of NRTI therapy prior to enrolment (median 115 weeks).
Riżultati minn prova (ACTG 241) vvalorizza terapija bi tliet drogi b’ VIRAMUNE, zidovudine u didanosine, mqabbla ma ’ waħda b’ zidovudine u didanosine, f’ 398 pazjenti infettati b’ HIV- 1 (valur medju ta 'referenza bażi 153 CD4+ ċelluli/ mm3; plażma HIV- 1 RNA 4. 59 log10 kopji/ ml), u li ngħataw 6 xhur terapija b’ NRTI, qabel bdew daħlu il- prova (valur medjan ta’ 115- il ġimgħa).
These heavily experienced patients demonstrated a significant improvement of the triple therapy group over the double therapy group for one year in both viral RNA and CD4+ cell counts.
Il- pazjenti li kellhom esperjenza u kienu fuq it- terapija bit- tliet drogi marru aħjar b’ mod sinifikanti għal sena, fil - livelli ta ’ RNA virali kif ukoll taċ- ċelluli CD4+, meta mqabbla ma ’ dawk li ħadu t- terapija b 'żewġ drogi.
A durable response for at least one year was documented in a trial (INCAS) for the triple therapy arm with VIRAMUNE, zidovudine and didanosine compared to zidovudine + didanosine or VIRAMUNE + zidovudine in 151 HIV-1 infected, treatment naive patients with CD4+ cell counts of 200-
F’ din il- prova kien hemm 151 pazjent infettat b' HIV- 1 li kienu inkonsapevoli dwar it - terapiji.
40 600 cells/ mm3 (mean 376 cells/ mm3) and a mean baseline plasma HIV-1 RNA concentration of 4.41 log10 copies/ ml (25,704 copies/ ml).
Dawn kellhom l- għadd ta ’ ċelluli CD4+ ta ’ 200- 600 ċelluli/ mm3 (medja 376 ċelluli/ mm3) u konċentrazzjoni ta ’ referenza bażi medja ta ’ HIV- 1 RNA fil- plażma ta ’ 4. 41 log10 kopji/ ml (25, 704 kopji/ ml).
2 mg/ kg within 72 hours of birth), or an ultra-short oral zidovudine regimen (mother:
2 mg/ kg fi żmien 72 sigħat mit- twelid), jew inkella kors b' doża żgħira ħafna orali ta ’ zidovudine (omm:
600 mg at the onset of labour and 300 mg every 3 hours until delivery; infant 4 mg/ kg twice daily for 7 days).
4 mg/ kg darbtejn kuljum għal sebat ijiem).
In the SAINT study conducted in South Africa, mother-infant pairs were randomised to receive oral VIRAMUNE (mother:
43 Fl- istudju SAINT, li sar fl- Afrika t’ Isfel, pari ta 'omm- trabi ġew magħżula b' addoċċ biex jingħataw VIRAMUNE mill- ħalq (omm:
200 mg during labor and 200 mg 24 to 48 hours postdelivery; infant:
200 mg waqt il- ħlas, 200 mg 24 sa 48 siegħa wara twelid; tarbija:
6 mg 24 to 48 hours postdelivery); or a short oral zidovudine plus lamivudine regimen (mother: zidovudine 600 mg, then 300 mg every 3 hours during labour, followed by 300 mg b. i. d. for 7 days postdelivery plus lamivudine 150 mg b. i. d. during labour and for 7 days postdelivery; infant: zidovudine 12 mg b. i. d. plus lamivudine 6 mg b. i. d. for 7 days [if infant weight < 2 kg, zidovudine 4 mg/ kg b. i. d. plus lamivudine 2 mg/ kg b. i. d. for 7 days]).
12 mg zidovudine b. i. d. flimkien ma '6 mg lamivudine b. i. d. għal 7 ijiem [jekk il- piż korporali ta' tarbija < 2 kg, zidovudine 4 mg/ kg b. i. d. flimkien ma 'lamivudine 2 mg/ kg b. i. d. għal 7 ijiem]).
There was no significant difference in HIV-1 transmission rates through 6 to 8 weeks between the VIRAMUNE group (5.7%, n = 652) and the zidovudine plus lamivudine group (3.6%, n = 649).
Ma kienx hemm differenzi sinifikanti fir- rata ta ’ kemm ixxerdet l- infezzjoni HIV- 1, fi żmien 6 sa 8 ġimgħat, bejn il- grupp ta ’ VIRAMUNE (5. 7%, n = 652) u l- grupp ta ’ zidovudine flimkien ma ’ lamivudine (3. 6%, n = 649).
In the SAINT study 68% of nevirapine-exposed mothers had resistant strains at approximately 4 weeks after delivery.
Fl- istudju SAINT, 68% ta ’ l- ommijiet li ġew esposti għal nevirapine, kellhom reżistenza għal razez għal madwar 4 ġimgħat wara t- twelid.
Furthermore in the case VIRAMUNE is used as single dose to prevent vertical transmission of HIV-1 infection, the risk of hepatotoxicity in mother and child cannot be excluded.
Barra minn hekk, ma tista 'tiġi eskluża l- ebda tossiċità fil- fwied ta ’ l- omm u t- tarbija meta VIRAMUNE jintuża bħala doża waħda biex jimpedixxi t- tixrid vertikali ta ’ l- infezzjoni bl- HIV- 1.
A blinded randomized clinical trial in women already taking antiretroviral therapy throughout pregnancy (PACTG 316) demonstrated no further reduction of vertical HIV-1 transmission when the mother and the child received a single VIRAMUNE dose during labour and after birth respectively.
Prova klinika fl- għama li saret bl- addoċċ fuq nisa li kienu diġà fuq terapija anti- retrovirali waqt it - tqala kollha (PACTG 316), uriet li ma kienx hemm tnaqqis fit- tixrid vertikali ta 'HIV- 1, meta l- omm u t- tarbija ngħataw doża waħda ta ’ VIRAMUNE waqt il- ħlas u wara t- twelid rispettivament.
HIV-1 transmission rates were similarly low in both treatment groups (1.3% in the VIRAMUNE group, 1.4% in the placebo group).
Ir- rati tat - tixrid ta ’ HIV- 1 kienu baxxi fiż- żewġ gruppi li ġew ittrattati (1. 3% fil- grupp ta ’ VIRAMUNE, 1. 4% fil- grupp tal- plaċebo).
VIRAMUNE tablets and oral suspension have been shown to be comparably bioavailable and interchangeable at doses up to 200 mg.
Intwera li kemm il- pilloli kif ukoll s- suspensjonijiet orali ta ’ VIRAMUNE għandhom bijodisponibilità komparabbli u jistgħu jittieħdu flok xulxin sa dożi ta '200 mg
Other published
Skond dejta pubblikata fuq 20 pazjent infettat b' HIV, l- valur Cmax ta ’ nevirapine waqt ekwilibriju kien ta ’ 5. 74 µg/ ml (5. 00- 7. 44) u ta ’ Cmin kien ta ’ 3. 73 µg/ ml (3. 20- 5. 08), b’ AUC ta ’ 109. 0 h* µg/ ml (96. 0- 143. 5), meta ngħataw ammont ta ’ 200 mg nevirapine.
41 data support these conclusions.
Informazzjoni oħra pubblikata taqbel ma ’ dawn il- konklużjonijiet.
Nevirapine is lipophilic and is essentially nonionized at physiologic pH.
Nevirapine huwa lipofiliku u f’ kundizzjonijiet ta ’ pH fiżjoloġiku ma jiġiex jonizzat.
In vitro studies with human liver microsomes suggest that oxidative metabolism of nevirapine is mediated primarily by cytochrome P450 isozymes from the CYP3A family, although other isozymes may have a secondary role.
Studji fil- laboratorju fuq mikrożomi tal- fwied tal- bniedem juru li nevirapine jiġi ossidat permezz ta ’ isoenzimi tat- tip CYP 3A, li jagħmlu parti mis- sistema taċ -
In a mass balance/ excretion study in eight healthy male volunteers dosed to steady state with nevirapine 200 mg given twice daily followed by a single 50 mg dose of 14C-nevirapine, approximately 91.4 ± 10.5% of the radiolabelled dose was recovered, with urine (81.3 ± 11.1%) representing the primary route of excretion compared to faeces (10.1 ± 1.5%).
Madwar 91. 4 ± 10. 5% ta 'doża radjutikkettata kienet irkuprata.
Thus cytochrome P450 metabolism, glucuronide conjugation, and urinary excretion of glucuronidated metabolites represent the primary route of nevirapine biotransformation and elimination in humans.
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.
Only a small fraction (< 5%) of the radioactivity in urine (representing < 3% of the total dose) was made up of parent compound; therefore, renal excretion plays a minor role in elimination of the parent compound.
Dan jindika li l- eliminazzjoni ta ’ nevirapine mill - kliewi hija baxxa ħafna.
Nevirapine has been shown to be an inducer of hepatic cytochrome P450 metabolic enzymes.
Instab li nevirapine jistimula l- produzzjoni ta ’ enzimi metaboliċi tas- sistema P450 li tinsab fil- fwied.
The pharmacokinetics of autoinduction are characterized by an approximately 1.5 to 2 fold increase in the apparent oral clearance of nevirapine as treatment continues from a single dose to two-to-four weeks of dosing with 200-400 mg/ day.
Dan l- effett jikkaġuna farmakokinetiċi karaterizzati b' żjieda ta ’ minn madwar 1. 5 darbiet sa 2 fir- rata ta 'eliminazzjoni tad- doża orali ta ’ nevirapine hekk kif waqt it- trattament jissokta minn doża waħda ta ’ 200- 400 mg/ jum għal ġimagħtejn - erba ġimgħat.
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.
Minħabba din l- eliminazzjoni jkun hemm tnaqqis bl - istess 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.
The results suggest that supplementing VIRAMUNE therapy with an additional 200 mg dose of VIRAMUNE following each dialysis treatment would help offset the effects of dialysis on nevirapine clearance.
Dawn ir- riżultati juru li għandha tiġi supplementata t- terapija b’ VIRAMUNE permezz ta ’ doża addizzjonali ta ’ 200 mg VIRAMUNE wara kull trattament ta 'dijaliżi, biex jagħmel tajjeb għall - iżbilanċ li jikkaġuna d - dijaliżi fir- rata ta' l- eliminazzjoni ta 'nevirapine mill- ġisem.
Otherwise patients with CLcr ≥ 20 ml/ min do not require an adjustment in VIRAMUNE dosing.
Pazjenti li għandhom rata ta ’ CLcr ta '≥ 20 ml/ min m’ għandhomx għalfejn jaġġustaw id- doża ta ’ VIRAMUNE.
Hepatic dysfunction:
Problemi fil- fwied:
A steady state study comparing 46 patients with mild (n=17:
Sar studju ta ’ stadju fiss li qabbel 46 pazjent ma ’ fibrosi tal fwied ħafifa (n=17:
In this study, the multiple dose pharmacokinetic disposition of nevirapine and the five oxidative
F’ dan l- istudju, id- dispożizzjoni farmakokinetika għal doża multipla ta ’ nevirapine u l- ħames metaboliti ossidattivi ma nbidlitx.
Patients with hepatic impairment should be monitored carefully for evidence of drug induced toxicity.
Pazjenti b’ indeboliment epatiku għandhom jiġu sorveljati b’ kawtela għal evidenza ta ’ tossiċità ikkaġunata mill - mediċina.
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.
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 fl - AUC 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 fis - sistema taċ- ċirkolazzjoni.
Because nevirapine induces its own metabolism with multiple dosing, this single dose study may not reflect the impact of hepatic impairment on multiple dose pharmacokinetics (see section 4.4).
Peress li nevirapine jinduċi l- metaboliżmu tiegħu stess b’ doża multipla, dan l- istudju waħdani jista ’ ma jirriflettiex l- impatt ta ’ indeboliment epatiku fuq il- farmakokinetika ta ’ doża multipla (ara sezzjoni 4. 4).
In the multinational 2NN study, a population pharmacokinetic substudy of 1077 patients was performed that included 391 females.
45 Fl- istudju multinazzjonali 2NN, sar sottostudju farmakokinetiku tal- popolazzjoni fuq 1077 pazjent li kien jinkludi 391 mara.
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.
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.
Data concerning the pharmacokinetics of nevirapine has been derived from two major sources: a 48 week paediatric trial 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.
Dejta rigward il- farmakokinetika ta 'nevirapine nkisbet minn żewġ sorsi ewlenin: prova pedjatrika ta' 48 ġimgħa (BI 1100. 1368) li saret fl- Afrika t' Isfel li kienet 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.
The results of the 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 naïve paediatric patients.
Ir- riżultati ta 'l- analiżi ta' 48 ġimgħa ta 'l- istudju BI 1100. 1368 ta' l- Afrika t' Isfel ikkonfermat li d- dożi ta 'nevirapine ta' 4/ 7 mg/ kg u l- 150 mg/ m2 kienu tollerati tajjeb u effettivament fit- trattament ta 'pazjenti pedjatri li ma jafux li qed jieħdu mediċina antiretrovirali.
In reproductive toxicology studies, evidence of impaired fertility was seen in rats.
Studji fuq it- tossiċità waqt ir- riproduzzjoni żvelaw indeboliment tas- sistema riproduttiva fil- firien.
Carbomer Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Sorbitol Sucrose Polysorbate 80 Sodium hydroxide (for pH-adjustment) Purified water
Carbomer Methyl parahydroxybenzoate (E218), Propyl parahydroxybenzoate (E216) Sorbitol Sucrose 46 Polysorbate 80 Sodium hydroxide (għal aġġustament ta ’ pH) Ilma purifikat.
The product should be used within 6 months of opening.
Il- prodott għandu jintuża fi żmien 6 xhur minn wara li jinfetaħ.
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.
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).
Each bottle contains 240 ml of oral suspension.
Kull flixkun fih 240 ml ta ’ suspensjoni orali.
Clear polypropylene 5 ml dispensing syringe with silicone rubber piston seal.
Siringa ċara magħmula minn polypropylene ta ’ 5 ml b’ siġill ta ’ parti ta ’ wara magħmul minn lastiku tas- silicone.
Clear low density polyethylene bottle-syringe adapter.
Adapter tal- flixkun siringa magħmula minn low density polyethylene ċar.
Instructions for administration:
Struzzjonijiet għall- għoti:
The required dosage volumes should be measured employing the enclosed dispensing syringe and adapter, as described in steps 1-5 below.
Il- volum ta 'doża meħtieġa għandu jiġi mkejjel billi tintuża s- siringa ta' forniment u l- adapter kif deskritt fl- istadji 1- 5 hawn isfel.
The maximum volume which can be measured with the dispensing syringe is 5 ml and therefore steps 3-5 must be repeated for dosage volumes greater than 5 ml.
Il- volum massimu li jista 'jiġi mkejjel bis- siringa ta' forniment hu ta '5 ml u għalhekk l- istadji 3- 5 għandhom jiġu ripetuti għal volumi ta' dożaġġ akbar minn 5 ml
Shake the bottle gently
Ħawwad il- flixkun bil- mod
Fit (by first pressing and then screwing) the adapter onto the open bottle neck
Qiegħed (billi l- ewwel tagħfas, imbaghad tinvita) l- adapter ma 'l- għonq miftuħ tal- flixkun
Insert the syringe into the adapter
Waħħal is- siringa ma 'l- adapter
Invert the bottle
Eqleb il- flixkun
Withdraw the required dosage volume
Iġbed l- ammont ta 'volum għad- doża meħtieġa
VIRAMUNE oral suspension should
Il- flixkun jista 'jinżamm issiġillat bl- għatu flessibli ta' l- adapter.
44 be used within 6 months after first opening of the bottle.
VIRAMUNE suspensjoni orali għandha tintuża fi żmien xahrejn minn meta l- ewwel infetaħ il- flixkun.
Disposal:
Rimi:
Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein, Germany
Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein Il- Ġermanja
18 June 1999 Date of latest renewal:
18 ta 'Ġunju 1999 Data ta' l- aħħar tiġdid:
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
45 ANNEX II
48 ANNESS II
Viramune 200 mg Tablets
Viramune 200 mg Pilloli
KG Binger Strasse 173 - 55216 Ingelheim am Rhein Germany
KG Binger Strasse 173 - 55216 Ingelheim am Rhein Il- Ġermanja
5th km Paiania-Markopoulo 194 00 Koropi Greece
5th km Paiania – Markopoulo 194 00 Koropi Il- Greċja
Viramune 50 mg/ 5 ml Oral suspension
Viramune 50 mg/ 5 ml suspensjoni orali
KG Binger Strasse 173 – 55216 Ingelheim am Rhein Germany
KG Binger Strasse 173 – 55216 Ingelheim am Rhein Il- Ġermanja
The Marketing Authorisation Holder will continue to submit the PSUR on a yearly basis.
Id- Detentur ta 'l- Awtorizzazzjoni għat- tqegħid fis- Suq ser ikompli jagħti l- PSUR kull sena.
47 ANNEX III
50 ANNESS III
49 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
52 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
BLISTER CARTON LABEL
TIKKETTA TAL- KARTUNA TAL- FOLJA
Viramune 200 mg tablets nevirapine
Viramune 200 mg pilloli nevirapine
Each tablet contains 200 mg of nevirapine (as anhydrate)
Kull pillola fiha 200 mg ta ’ nevirapine (bħala anhydrate).
Excipients: includes lactose (see leaflet for further information)
Sustanzi mhux attivi: jinkludu lattosju (ara fuljett ta ’ tagħrif għal aktar informazzjoni)
Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein Germany
Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein Il- Ġermanja
53 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
56 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Initiation pack containing 14 tablets
Pakkett tal- bidu tat- trattament li fih 14- il pillola
55 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
58 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
56 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
59 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
Viramune 50 mg/ 5 ml oral suspension nevirapine
Viramune 50 mg/ 5 ml suspensjoni orali nevirapine
Each ml of oral suspension contains 10 mg of nevirapine (as hemihydrate)
Kull ml ta ’ suspensjoni orali fih 10 mg nevirapine (bħala hemihydrate)
Excipients: includes sucrose, sorbitol, methyl parahydroxybenzoate, propyl parahydroxybenzoate (see leaflet for further information)
Sustanzi mhux attivi: jinkludu sukrożju, sorbitol, methyl parahydroxybenzoate, propyl parahydroxybenzoate (ara l- fuljett għal aktar informazzjoni)
240 ml oral suspension
240 ml suspensjoni orali
Oral use Shake gently before use Read the package leaflet before use.
Aqra l- fuljett ta ’ tagħrif qabel l- użu
Child resistant closure
Għatu reżistenti għat- tfal
EXP To be used within 6 months after opening the bottle
JIS Għandu jintuża fi żmien 6 xhur minn wara li jinfetaħ il- flixkun
BOTTLE CARTON LABEL
TIKKETTA TAL- KARTUNA TAL- FLIXKUN
Each ml of oral suspension contains 10 mg of nevirapine (as hemihydrate)
Kull ml ta ’ suspensjoni orali fih 10 mg ta ’ nevirapine (bħala hemihydrate)
Excipients: includes sucrose, sorbitol, methyl parahydroxybenzoate, propyl parahydroxybenzoate (see leaflet for further information)
Sustanzi mhux attivi: jinkludu sucrose, sorbitol, methyl parahydroxybenzoate, propyl parahydroxybenzoate (ara l- fuljett għal aktar informazzjoni)
Oral use Shake gently before use Read the package leaflet before use.
Ħawwad bil- mod qabel tuża Aqra l- fuljett ta ’ tagħrif qabel l- użu.
MARKETING AUTHORISATION NUMBER(S)
NUMRU( I) TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ
Viramune 50 mg/ 5 ml
Viramune 50 mg / 5 ml
61 PACKAGE LEAFLET:
64 FULJETT TA 'TAGĦRIF:
INFORMATION FOR THE USER
INFORMAZZJONI GĦAL MIN IRID JAGĦMEL UŻU MINNHA
VIRAMUNE 200 mg tablets nevirapine
VIRAMUNE 200 mg pilloli nevirapine
- If you have further questions, please ask your doctor or pharmacist.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
What VIRAMUNE is and what it is used for 2.
X' inhu VIRAMUNE u għalxiex jintuża 2.
Before you take VIRAMUNE 3.
Qabel ma tieħu VIRAMUNE 3.
How to take VIRAMUNE 4.
Kif għandek tieħu VIRAMUNE 4.
Possible side effects 5 How to store VIRAMUNE 6.
Effetti sekondarji li jista ’ jkollu 5 Kif taħżen VIRAMUNE 6.
WHAT VIRAMUNE IS AND WHAT IT IS USED FOR
X' INHU VIRAMUNE U GĦALXIEX JINTUŻA
VIRAMUNE belongs to a group of medicines called antiretrovirals, used in the treatment of Human Immunodeficiency Virus (HIV-1) infection.
VIRAMUNE jappartjeni għal grupp ta ’ mediċini li jissejħu antiretrovirali, użati fit- trattament ta ’ infezzjonijiet ikkaġunati mill- Vajrus ta ’ Immunodefiċjenza Umana (HIV- 1).
HIV is spread by contact with infected blood or sexual contact with an infected individual.
HIV jinxtered b’ kuntatt b’ demm infettat jew kuntatt sesswali ma ’ individwu infettat.
VIRAMUNE belongs to the class of non-nucleoside reverse transcriptase inhibitors (NNRTIs).
VIRAMUNE jappartjeni għal kategorija ta’ inibituri non- nucleoside reverse transcriptase (NNRTIs).
Viramune fights HIV-1 infection by reducing the amount of the virus in the blood.
Viramune jiġġieled l- infezzjoni ta ’ HIV- 1 billi jnaqqas l- ammont ta ’ vajrus fid- demm.
VIRAMUNE is prescribed for use in combination with other HIV antiretrovirals.
VIRAMUNE huwa preskritt biex jintuża flimkien ma ’ antiretrovirali oħra.
Your doctor will determine which medicines are best for you.
It- tabib tiegħek ser jistabilixxi liema mediċini huma l- aħjar għalik.
BEFORE YOU TAKE VIRAMUNE
QABEL MA TIEĦU VIRAMUNE
Do not take VIRAMUNE
Tieħux VIRAMUNE
- if you are allergic (hypersensitive) to nevirapine or any of the other ingredients of VIRAMUNE
- jekk għandek allerġija (sensittività eċċessiva) għal nevirapine jew xi sustanza oħra li tinsab
(see other ingredients).
f’ VIRAMUNE (ara sustanzi oħra).
- if you previously experienced inflammation of the liver (hepatitis), severe skin rash, or liver
- jekk qabel kellek infjammazzjoni tal- fwied (epatite), raxx sever fuq il- ġilda, jew ħsara fil- fwied
damage while on VIRAMUNE treatment.
waqt li kont fuq kura ta 'VIRAMUNE.
- if you have permanent liver disease or changes in liver function
- jekk għandek marda permanenti fil- fwied jew bidliet fil- funzjoni tal- fwied
- if you are taking products containing St John’ s Wort (Hypericum perforatum) as this may stop
- jekk qed tieħu prodotti li fihom St. John’ s Wort (Hypericum perforatum)
VIRAMUNE from working properly.
peress li dan jista ’ jimpedixxi ’ l VIRAMUNE milli jaħdem sew.
Take special care with VIRAMUNE
Oqgħod attent ħafna meta tieħu VIRAMUNE
During the first 18 weeks of treatment with VIRAMUNE you should watch out for signs of liver or skin reactions as these can become severe and even life threatening.
L- ewwel 18- il ġimgħa ta 'trattament b' VIRAMUNE huwa importanti li inti toqgħod attent ħafna sabiex jintgħarfu sinjali ta ’ reazzjonijiet tal- fwied jew tal- ġilda peress li dawn jistgħu jaggravaw u jkunu ta ’ periklu għal ħajja.
62 If you experience severe rash or hypersensitivity (allergic reactions that may appear in the form of rash accompanied by other side effects such as
65 Jekk tesperjenza raxx sever jew sensittività eċċessiva (reazzjonijiet allerġiċi li jistgħu jidhru f’ forma ta ’ raxx akkumpanjat minn effetti sekondarji oħra bħal:
- fever,
- deni
- blistering,
- nfafet
- mouth sores,
- ġrieħi fil- ħalq
- eye inflammation,
- infjammazzjoni ta ’ l- għajnejn
- facial swelling,
- nefħa fil- wiċċ
- general swelling,
- nefħa ġenerali
- shortness of breath,
- qtugħ ta ’ nifs
- muscle or joint aches,
- uġigħ fil- muskolu jew fil- ġogi
- general feelings of illness,
- tħoss li ma tiflaħx b’ mod ġenerali
- or abdominal pain
- jew uġigħ addominali
YOU SHOULD DISCONTINUE TAKING VIRAMUNE AND YOU MUST CONTACT your doctor IMMEDIATELY as such reactions can be potentially life-threatening or lead to death.
GĦANDEK TIEQAF TIEĦU VIRAMUNE U GĦANDEK TIKKUNTATTJA lit- tabib tiegħek MINNUFIH peress li reazzjonijiet bħal dawn jistgħu jkunu ta ’ periklu għal ħajja jew iwasslu għal mewt.
If you ever have only mild rash symptoms without any other reaction please inform your doctor immediately, who will advise you whether you should stop taking VIRAMUNE.
Jekk qatt ikollok xi sintomi ħfief ta ’ raxx mingħajr reazzjoni oħra jekk jogħġbok informa lit- tabib tiegħek minnufih, li ser jagħtik parir jekk għandekx tieqaf tieħu VIRAMUNE
If you experience symptoms suggesting a damage of the liver, such as
Jekk tħoss sintomi li jistgħu jissuġerixxu ħsara lill- fwied, bħal
- loss of appetite,
- nuqqas t’ aptit,
- feeling sick (nausea),
- tħossok ma tiflaħx (dardir),
- vomiting,
- remettar,
- yellow skin (jaundice),
- ġilda safranija (suffejra)
- abdominal pain
- uġigħ addominali
you should discontinue taking VIRAMUNE and must contact your doctor immediately.
għandek tieqaf tieħu VIRAMUNE u għandek tikkuntattja lit- tabib tiegħek minnufih.
If you develop severe hepatic, skin or hypersensitivity reactions whilst taking VIRAMUNE, NEVER TAKE VIRAMUNE again without referring to your doctor.
Jekk tiżviluppa reazzjonijiet severi tal- fwied jew tal- ġilda severi, jew ta ’ sensittività eċċessiva waqt li qed tieħu VIRAMUNE, M’ GĦANDEK QATT TIEĦU VIRAMUNE DARB’ OĦRA mingħajr ma tirreferi lit- tabib tiegħek.
You must take the dosage of Viramune as prescribed by your doctor.
Għandek tieħu d- doża ta ’ Viramune li kitiblek fuq ir- riċetta t- tabib tiegħek.
This is especially important within the first 14 days of treatment (see more information in How to take VIRAMUNE).
Dan hu importanti speċjalment fl- ewwel 14- il jum ta ’ kura (ara aktar informazzjoni f’ Kif għandek tieħu VIRAMUNE).
The following patients are at increased risk for developing liver problems:
Il- pazjenti li ġejjin jinsabu f’ riskju ogħla li jiżviluppaw problemi tal- fwied:
- women
- nisa
- infected with hepatitis B or C
- persuni infettati b’ epatite B jew Ċ
- abnormal liver function tests
- testijiet abnormali ta ’ kif qed jaħdem il- fwied
- higher CD4 cell counts at start of Viramune therapy (women more than 250 cells/ mm³, men more
- għadd ogħla ta ’ ċelloli CD4 fil- bidu tat- terapija b’ Viramune (nisa aktar minn 250 ċellola/ mm³,
than 400 cells/ mm³)
irġiel aktar minn 400 ċellola/ mm³)
In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection (AIDS defining illness), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
F' xi pazjenti li għandhom infezzjoni avvanzata ta 'HIV (AIDS) u storja ta' reazzjonijiet opportunistiċi (mard mfisser bħala AIDS), is- sinjali u s- sintomi ta 'infjammazzjoni minn infezzjonijiet li kellhom qabel jistgħu jerġgħu jitfaċċaw wara li jinbeda mill- ġdid it- trattament kontra l- HIV.
It is believed that these symptoms are due to an improvement in the body’ s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Hu maħsub li dawn is- sintomi huma dovuti għal titjib fis- sistema immunitarja tal- ġisem, li jippermetti lil ġisem jiġġieled l- infezzjonijiet li setgħu kienu preżenti mingħajr sintomi ovvji.
If you notice any symptoms of infection, please inform your doctor immediately.
Jekk tinnota xi sintomi ta 'infezzjoni, jekk jogħġbok għarraf lit- tabib tiegħek minnufih.
Changes of body fat may occur in patients receiving combination antiretroviral therapy.
Bidliet fix- xaħam tal- ġisem jistgħu jseħħu f' pazjenti li jkunu fuq terapija antiretrovirali kombinata.
Contact your doctor if you notice changes in body fat.
Ikkuntattja lit- tabib tiegħek jekk tinduna f' xi bidliet fix- xaħam tal- ġisem tiegħek.
Some patients taking combination antiretroviral therapy may experience death of bone tissue (osteonecrosis).
Xi pazjenti li qed jieħdu terapija antiretrovirali kombinata jistgħu jesperjenzaw mewt ta 'tessut tal- għadam (osteonekrosi).
The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe weakness of the immune system, higher body mass index may be some of the many risk factors for developing this disease.
It- tul tat- terapija antiretrovirali kombinata, l- użu ta 'kortikosterojdi, il- konsum ta' alkoħol, debolezza tas- sistema immuni severa, indiċi ogħla fil- piż tal - ġisem, fost oħrajn, jistgħu jkunu xi wħud mill- ħafna fatturi li jippredisponu l- iżvilupp ta 'din il- marda.
Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Sinjali ta 'osteonekrosi huma ebusija fil- ġogi, uġigħ (speċjalment fil- ġenbejn, l- irkoppa u l- ispallejn) u
If you notice any of these symptoms please inform your doctor.
Jekk tinnota xi wieħed minn dawn is- sintomi, jekk jogħġbok informa lit- tabib tiegħek.
VIRAMUNE is not a cure for HIV infection and you may continue to develop infections or other
VIRAMUNE mhix kura għall- infezzjoni ta ’ HIV u jista ’ jkun li int tkompli tiżviluppa infezzjonijiet jew mard ieħor assoċjat ma ’ l- infezzjoni ta ’ HIV.
It is therefore important to remain under the care of your doctor while taking VIRAMUNE.
Huwa għalhekk importanti li inti tibqa ’ taħt il- kura tat- tabib tiegħek waqt li qed tieħu VIRAMUNE.
Even by taking anti-HIV medicinal product you still may pass HIV on to others through sexual contact or contamination with blood.
Anke meta tieħu prodott mediċinali kontra l- HIV inti xorta tista ’ tgħaddi l- HIV lil oħrajn permezz ta ’ kuntatt sesswali jew permezz ta ’ kontaminazzjoni bid- demm.
Use in children VIRAMUNE tablets can be taken by children 16 years of age or older.
Użu fi tfal Il- pilloli VIRAMUNE jistgħu jittieħdu minn tfal li għandhom 16- il sena jew aktar.
Additionally VIRAMUNE tablets can be taken by adolescents under 16 years of age who weigh 50 kg or more or whose body surface area is above 1.25 m2.
Barraminhekk il - pilloli VIRAMUNE jistgħu jittieħdu minn adoloxxenti taħt is- 16- il sena li jiżnu 50 kg jew aktar jew li l- erja superfiċjali korporali tagħhom hi 'l fuq minn 1. 25 m2.
For smaller children an oral suspension liquid form is available.
Għal tfal iżgħar hemm suspensjoni likwida li tittieħed mill- ħalq.
You should inform your doctor of all other medicines you are taking before you start taking VIRAMUNE because he or she might need to monitor whether the other medicines are still having their desired effects and make necessary dose- adjustments.
Għandek tinforma t- tabib ta 'kull mediċina oħra li tkun qed tieħu qabel ma tibda tieħu VIRAMUNE sabiex hu jew hi jkun jista jissorvelja jekk il- mediċini humiex ikollhom l - effett mixtieq u sabiex jagħmel l- aġġustamenti meħtieġa tad- doża.
You should carefully read the package leaflet of the other HIV medicinal products which you will be taking in combination with VIRAMUNE.
Inti għandek taqra sew il- fuljett ta ’ tagħrif tal- prodotti mediċinali l- oħra ta ’ l- HIV li inti ser tieħu flimkien ma ’ VIRAMUNE.
It is particularly important that you tell your doctor if you are taking or have recently taken:
Huwa partikolarment importanti li tgħid lit- tabib tiegħek jekk qed tieħu jew riċentement ħadt:
- St John’ s Wort (Hypericum perforatum, medicine to treat depression)
- St John’ s Wort (Hypericum perforatum, mediċina li tikkura d- dipressjoni)
- rifampicin (medicine to treat tuberculosis)
- rifampicin (mediċina li tikkura t- tuberkolosi)
- rifabutin (medicine to treat tuberculosis)
- rifabutin (mediċina li tikkura t- tuberkolosi)
- macrolides e. g. clarithromycin (medicine to treat bacterial infections)
- makrolidi (eż. clarithromycin) (mediċina li tikkura l- infezzjonijiet batteriċi)
- fluconazole (medicine to treat fungal infections)
- fluconazole (mediċina kontra l- infezzjonijiet fungali)
- ketoconazole (medicine to treat fungal infections)
- ketoconazole (mediċina li tikkura l- infezzjonijiet fungali)
- itraconazole (medicine to treat fungal infections)
- itraconazole (mediċina li tikkura l- infezzjonijiet fungali)
- methadone (medicine used for treatment of opiate addicts)
- methadone (mediċina użata biex tikkura ’ l persuni viżjati bil- loppji)
- warfarin (medicine to reduce blood clotting)
- warfarin (mediċina li tnaqqas il- formazzjoni ta ’ emboli tad- demm)
- hormonal contraceptives, e. g. the “ pill”
- kontraċettivi ormonali eż il - “ pill ”
- atazanavir (another medicine to treat HIV-infection)
- atazanavir (mediċina oħra li tikkura l- infezzjonijiet tal- HIV)
- lopinavir/ ritonavir (another medicine to treat HIV-infection)
- lopinavir/ ritonavir (mediċina oħra li tikkura l- infezzjonijiet tal- HIV)
- fosamprenavir (another medicine to treat HIV-infection)
- fosamprenavir (mediċina oħra li tikkura l- infezzjonijiet tal- HIV)
- efavirenz (another medicine to treat HIV-infection)
- efavirenz (mediċina oħra li tikkura l- infezzjonijiet tal- HIV)
Your doctor will carefully monitor the effect of VIRAMUNE and any of these medicines if you are taking VIRAMUNE and any of these medicines together.
It- tabib tiegħek ser jissorvelja mill- qrib l- effett ta ’ VIRAMUNE u kwalunkwe wieħed minn dawn il - mediċini jekk qed tieħu VIRAMUNE u xi wieħed minn dawn flimkien miegħu
If you are undergoing dialysis, your doctor may consider a dose adjustment of VIRAMUNE as VIRAMUNE can be partly washed out of your blood by dialysis.
Jekk qed ikollok dijaliżi, it- tabib tiegħek jista ’ jikkonsidra li jaġġusta d- doża ta ’ VIRAMUNE peress li VIRAMUNE jista ’ jiġi eliminat mid- demm tiegħek bid- dijalizi.
Taking VIRAMUNE with food and drink
Meta tieħu VIRAMUNE ma 'l- ikel u max- xorb:
There are no restrictions on taking VIRAMUNE with food and drink.
M' hemm l- ebda restrizzjoni fuq it- teħid ta 'pilloli VIRAMUNE ma' l- ikel u x- xorb.
You should discontinue breast feeding if you are taking VIRAMUNE.
67 Għandek twaqqaf tredda ’ jekk qed tieħu l- pilloli VIRAMUNE.
It is in general recommended that you do not breast-feed if you have HIV infection in order to lower the risk of passing the infection on to your baby.
Hija rakkomandazzjoni ġenerali li m’ għandekx tredda ’ jekk int infettata b’ HIV sabiex tnaqqas ir- riskju li tgħaddi l- infezzjoni lit- tarbija tiegħek.
64 Driving and using machines
Sewqan u tħaddim ta 'magni
There are no specific studies on the ability to drive vehicles and use machinery.
M’ hemm l- ebda studju speċifiku fuq il- ħila biex issuq jew tħaddem magni
Important information about some of the ingredients of VIRAMUNE
Tagħrif importanti dwar xi sustanzi li jinsabu fil- pilloli VIRAMUNE
HOW TO TAKE VIRAMUNE
KIF GĦANDEK TIEĦU VIRAMUNE
Always take VIRAMUNE exactly as your doctor has told you.
Dejjem għandek tieħu VIRAMUNE skond il- parir tat- tabib.
VIRAMUNE is in a tablet form and should only be taken by mouth.
VIRAMUNE huwa f' għamla ta 'pillola u għandu jittieħed mill- ħalq.
The usual dose is one 200 mg tablet for the first 14 days of treatment (this'lead in 'period has been shown to lower the incidence of skin rash) followed by one 200 mg tablet twice daily.
Id- doża li ġeneralment tingħata hija ta ’ pillola waħda ta '200 mg għall- ewwel 14- il jum ta' trattament (dan il- perijodu tal- bidu instab li jnaqqas l- inċidenza ta 'raxx tal- ġilda) segwita b' pillola waħda ta' 200 mg darbtejn kuljum.
VIRAMUNE will always be taken in combination with other HIV antiretrovirals, for which you should follow the instructions within the supplied package leaflet.
VIRAMUNE għandu dejjem jittieħdu flimkien ma 'antiretrovirali ta' HIV oħrajn, li int għandek isegwi l- istruzzjonijiet tagħhom fil- fuljett li jinsab fil- pakkett.
VIRAMUNE is also available in an oral suspension liquid form, which is particularly suitable if you have problems swallowing tablets, or for children weighing less than 50 kg or having a body surface area less than 1.25 m2.
VIRAMUNE huwa disponibbli wkoll f' għamla ta 'suspensjoni likwida li tittieħed mill- ħalq, li hu adattat b' mod partikolari jekk għandek problemi biex tibla l- pilloli jew għal tfal li jiżnu anqas minn 50 kg jew għandom erja superfiċjali korporali inqas minn 1. 25 m2.
It is essential to follow strictly the once a day dosage during the 14-day ‘ lead in’ period before rising to the twice daily dosage.
Huwa essenzjali li ssegwi b' mod strett id- doża ta 'pillola darba kuljum matul l- ewwel 14- il jum' tal- bidu 'qabel ma żżid id- doża għal darbtejn kuljum.
If you have any rash within this period see your doctor before increasing the dose.
Jekk ikollok xi raxx matul dan il- perijodu ara t- tabib tiegħek qabel ma żżid id- doża.
You should continue to take VIRAMUNE for as long as instructed by your doctor.
Għandek tibqa 'tieħu l- pilloli VIRAMUNE sakemm ikun qallek biex tagħmel dan it- tabib tiegħek.
As explained in ‘ Take special care with VIRAMUNE’, above, your doctor will monitor you with liver tests or for undesirable effects such as rash.
Kif spjegat fit- taqsima ‘ Oqgħod attent ħafna meta tieħu VIRAMUNE ’, hawn fuq, it- tabib tiegħek għandu jissorvelja t- testijiet tal- fwied tiegħek jew jara għal xi effetti mhux mixtieqa bħal raxx.
Depending on the outcome he or she may decide to interrupt or stop your VIRAMUNE treatment.
Skond ir- riżultati hu jew hi jista 'jiddeċiedi biex iwaqqaf it- trattament tiegħek b' pilloli VIRAMUNE.
He or she might then decide to restart you on a lower dose.
Hu jew hi jistgħu mbagħad jiddeċiedu biex jibdew mill- ġdid fuq doża aktar baxxa.
If you take more VIRAMUNE than you should
Jekk tieħu aktar VIRAMUNE milli suppost għandek:
Do not exceed the dose prescribed by your doctor and described in this leaflet.
M' għandekx taqbeż id- doża li t- tabib tiegħek ikun kitiblek u mfissra f' dan il- fuljett.
There is at present little information on the effects of VIRAMUNE overdose.
Attwalment, hemm biss ftit tagħrif fuq l- effetti ta 'doża eċċessiva b' VIRAMUNE.
Consult your doctor if you have taken an overdose.
Ikkonsulta mat- tabib tiegħek jekk tieħu xi doża eċċessiva.
If you forget to take VIRAMUNE
Jekk tinsa tieħu VIRAMUNE
Try not to miss a dose.
Ipprova titlifx milli tieħu doża.
When you notice within 8 hours, take the next dose as soon as possible.
Jekk tinduna fi żmien 8 sigħat, ħu d- doża li jmiss kemm jista ’ jkun malajr.
If you notice later take the next regular dose at the scheduled time.
Jekk tinduna wara dan iż- żmien hu d- doża regolari li jmiss tiegħek fil- ħin skedat.
If you stop taking VIRAMUNE
68 Jekk tieqaf tieħu VIRAMUNE:
Taking all doses at the appropriate times greatly increase the effectiveness of your medicinal product combination regimen and reduces the development of viral resistance.
Intwera li jekk tieħu d- dożi kollha fil- ħinijiet xierqa tiżdied bi kbir l- effettività tal- kors kkombinat tal- prodott mediċinali tiegħek u jonqos l- iżvilupp ta 'reżistenza virali.
Therefore, unless your doctor instructs you to stop treatment, it is important to keep taking VIRAMUNE correctly, as described above.
Għalhekk, sakemm it- tabib tiegħek ma jgħidlekx sabiex twaqqaf it- trattament, huwa importanti li tibqa 'tieħu VIRAMUNE b' mod korrett, kif imfisser hawn fuq.