FrancophonIA/ELRC3.0 huggingface dataset:
English: At week 48, non-inferiority was shown with 68 % of patients in the group treated with nelfinavir and 69 % patients treated with fosamprenavir/ritonavir having plasma HIV-1 RNA <400 copies/ml whereas 53 % in the nelfinavir and 55 % in the fosamprenavir/ritonavir patients had HIV-1 RNA <50 copies/ml (intent-to-treat, rebound/discontinuation = failure).
Maltese: ġimgħa, nuqqas ta' inferjorità intweriet b'68 % tal-pazjenti fil-grupp ikkurat b'nelfinavir u 69 % talpazjenti kkurati b'fosamprenavir/ritonavir li kellhom RNA ta' HIV-1 fil-plażma ta' < 400 kopja/ml filwaqt li 53 % tal-pazjenti b'nelfinavir u 55 % tal-pazjenti b'fosamprenavir/ritonavir kellhom RNA ta' HIV-1 ta' <50 kopja/ml (ħsieb biex tikkura, rkadar/twaqqif = falliment).
English: The following adverse events with an at least possible relationship to nelfinavir (i.e. adverse reactions) were reported most frequently: diarrhoea, nausea, and rash.
Maltese: L-avvenimenti avversi li ġejjin li huma mill-inqas possibbilment konnessi ma' nelfinavir (i.e. reazzjonijiet avversi) kienu rrapportati l-aktar frekwenti: dijarea, tqalligħ, u raxx.
English: Summary of Steady-state AUC24 of nelfinavir in Paediatric Studies
Maltese: Sommarju ta' l-AUC24 fi Stat Fiss ta' nelfinavir fi Studji Pedjatriċi
English: Skin and subcutaneous tissue disorders: Very rare (≤ 0.01 %), including isolated reports: Erythema multiforme.
Maltese: Rari ħafna (≤ 0.01 %), inkluż rapporti iżolati:
English: • Store in the original container.
Maltese: • Aħżen fil-pakkett oriġinali.
English: Cross-resistance between nelfinavir and reverse transcriptase inhibitors is unlikely because different enzyme targets are involved.
Maltese: Ir-reżistenza inkroċjata bejn nelfinavir u l-inibituri ta' reverse transcriptase mhijiex probabbli minħabba li hemm targits ta' l-enzimi differenti involuti.
English: After multiple dosing with 750 mg every 8 hours for 28 days (steady-state), peak plasma concentrations (Cmax) averaged 3-4 µg/ml and plasma concentrations prior to the next dose (trough) were 1-3 µg/ml.
Maltese: Wara dożi multipli b'750 mg kull 8 sigħat għal 28 jum (fi stat stabbli), konċentrazzjonijiet massimi tal-plażma (Cmax) kellhom medja ta' 3-4 µg/ml u konċentrazzjonijiet fil-plażma qabel id-doża li jkun imiss (il-punt ta' l-aktar konċentrazzjoni baxxa ) kienu ta' 1-3 µg/ml.
English: • Amiodarone or quinidine (for an uneven heart beat)
Maltese: • Amiodarone jew quinidine (għall-kura ta' taħbit tal-qalb irregolari)
English: 18 to 22 kg over 22 kg
Maltese: 18 sa 22 kg 'l fuq minn 22 kg
English: Median baseline HIV-1 RNA was 4.8 log10 copies/ml in both treatment groups.
Maltese: Medjan tal-RNA ta' HIV-1 fil-linja bażi kien ta' 4.8 log10 kopja/ml fiż-żewġ gruppi ta' kura.
English: The pharmacokinetics of nelfinavir have been investigated in 5 studies in paediatric patients from birth to 13 years of age.
Maltese: Il-farmakokinetika ta' nelfinavir kienet investigata f'5 studji f'pazjenti pedjatriċi b'età mit-twelid sa 13-il sena.
English: Uncommon (≥ 0.1 % - ≤ 1 %): vomiting, pancreatitis/blood amylase increased.
Maltese: Mhux komuni (≥ 0.1 % - ≤ 1 %): rimettar, pankrejatite/żjieda fl-amylase fid-demm.
English: Rifampicin 600 mg qd x 7 days (Nelfinavir 750 mg q8h x 5-6 days)
Maltese: Rifampicin 600 mg qd x 7 ijiem (Nelfinavir 750 mg q8h x 5-6 ijiem)
English: Of 19 patients for whom both phenotypic and genotypic analyses were performed on clinical isolates, 9 patients isolates showed reduced susceptibility (5- to 93-fold) to nelfinavir in vitro.
Maltese: Minn 19-il pazjent li għalihom analiżi fenotipiċi u ġenotipiċi kienu magħmula f'iżolati kliniċi, 9 pazjenti wrew suxxettibbilità mnaqqsa (minn 5 sa 93 darba) għal nelfinavir in vitro.
English: Children:
Maltese: Reżistenza:
English: Anticonvulsants Phenytoin 300 mg qd x 7 days (Nelfinavir 1250 mg bid x 14 days)
Maltese: Sustanzi kontra l-konvulżjonijiet Phenytoin 300 mg qd x 7 ijiem (Nelfinavir 1250 mg bid x 14-il ġurnata)
English: Anti infective Agents Rifabutin 300 mg QD (Nelfinavir 750 mg TID)
Maltese: Sustanzi kontra l-infezzjonijiet Rifabutin 300 mg QD (Nelfinavir 750 mg TID)
English: The median increase from baseline in CD4+ cell count over 48 weeks was 207 cells/mm3 and 203 cells/mm3 in the nelfinavir and fosamprenavir/ritonavir groups respectively.
Maltese: Iż-żjieda medja mill-linja bażi fl-għadd ta' ċelluli CD4+ matul lt-48 ġimgħa kien ta' 207 cellula/mm3 u 203 ċellula/mm3 fil gruppi b'nelfinavir u b'fosamprenavir/ritonavir rispettivament.
English: Clinical isolates (n=5) with decreased susceptibility to zidovudine, lamivudine, or nevirapine remain fully susceptible to nelfinavir in vitro.
Maltese: Iżolati kliniċi (n=5) b'suxxettibbilità mnaqqsa għal zidovudine, għal lamivudine, jew għal nevirapine jibqgħu kompletament suxxettibbli għal nelfinavir in vitro.
English: Increase in AUC, Cmax and Tmax for Nelfinavir in Fed State Relative to Fasted State Following 1250 mg VIRACEPT (5 x 250 mg tablets)
Maltese: Żjieda fl-AUC, Cmax u Tmax ta' Nelfinavir Wara l-Ikel Relattiv għal Stat sajjem Wara 1250 mg VIRACEPT (5 pillola ta' 250 mg)
English: Saquinavir 1200 mg single dose (nelfinavir 750 mg TID X 4 days)
Maltese: Saquinavir 1200 mg, doża waħda (nelfinavir 750 mg TID X 4 ijiem)
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Maltese: • F'60 ġurnata sa meta jrid tintlaħaq mira importanti (farmakoviġilanza jew tnaqqis ta' riskju)
English: HMG-CoA reductase inhibitors (statins): HMG-CoA reductase inhibitors may interact with protease inhibitors and increase the risk of myopathy, including rhabdomyolysis.
Maltese: Inibituri ta' HMG-CoA reductase jistgħu jinteraġixxu ma' inibituri tal-protease u jżidu r-riskju ta' mijopatija, inkluż rabdomijolisi.
English: • Do not use after the expiry date stated on the label and carton.
Maltese: • Tużax wara d-data ta' skadenza li tidher fuq it-tikketta u l-kartuna.
English: Conversely, following ritonavir therapy, 6 of 7 clinical isolates with decreased ritonavir susceptibility (8- to 113-fold) in vitro compared to baseline also exhibited decreased susceptibility to nelfinavir in vitro (5- to 40 fold).
Maltese: Bil-maqlub, wara terapija b'ritonavir, 6 minn 7 iżolati kliniċi b‘suxxettibbilità mnaqqsa għal ritonavir (minn 8 sa 113 darba ) in vitro meta mqabbla ma' iżolati tal-linja bażi li taqbel, urew ukoll suxxettibbilità mnaqqsa għal nelfinavir in vitro (minn 5 sa 40 darba).
English: Patients receiving VIRACEPT BID (n=10) achieved nelfinavir Cmax of 4.0 ± 0.8 µg/ml and morning and evening trough concentrations of 2.2 ± 1.3 µg/ml and 0.7 ± 0.4 µg/ml, respectively.
Maltese: Pazjenti li kienu qed jirċievu VIRACEPT BID (n=10) laħqu s-Cmax ta' nelfinavir ta' 4.0 ± 0.8 µg/ml u konċentrazzjonijiet baxxi ta' filgħodu u ta' filgħaxija ta' 2.2 ±1.3 µg/ml u ta' 0.7 ± 0.4 µg/ml, rispettivament.
English: Weight loss and general physical decline was observed in monkeys together with general evidence of gastrointestinal toxicity.
Maltese: Tnaqqis fil-piż u kondizzjoni ġenerali fiżika li tmur għall-agħar kienu osservati fix-xadini flimkien ma' evidenza ta' tossiċità gastro-intestinali.
English: VIRACEPT 50 mg/g oral powder is provided in HDPE plastic bottles fitted with polypropylene child resistant closures with a polyethylene liner.
Maltese: VIRACEPT 50 mg/g trab orali huwa pprovdut fi fliexken tal-plastik HDPE li għandhom tapp talpolypropylene reżistenti għat-tfal li fih inforra tal-polyethylene.
English: Mechanism of action: HIV protease is an enzyme required for the proteolytic cleavage of the viral polyprotein precursors to the individual proteins found in infectious HIV.
Maltese: Il-protease ta' l-HIV hija enzima meħtieġa għall-qtugħ protejolitiku talprekursuri tal-poliproteini virali (proteolytic cleavage of the viral polyprotein precursors) għallproteini individwali li jinsabu f'HIV infettiva.
English: Ritonavir 100 mg or 200 mg BID (nelfinavir 1250 mg BID morning administration)
Maltese: Ritonavir 100 mg or 200 mg BID (nelfinavir 1250 mg BID għoti fil-għodu)
English: Antigout preparation Colchicine
Maltese: Preparazzjoni kontra l-gotta Colchicine
English: Increased alanine aminotransferase, increased aspartate aminotransferase, neutropenia, blood creatinine phosphokinase increased, neutrophil count decreased
Maltese: Żjieda fl-alanine aminotransferase, żjieda fl-aspartate aminotransferase, newtropenja, żjieda fil-creatinine phosphokinase tad-demm, tnaqqis flgħadd ta' newtrofili
English: Antiviral activity in vitro: the antiviral activity of nelfinavir in vitro has been demonstrated in both HIV acute and chronic infections in lymphoblastoid cell lines, peripheral blood lymphocytes and monocytes/macrophages.
Maltese: L-attività antivirali in vitro ta' nelfinavir kienet murija f'infezzjonijiet ta' lHIV, kemm akuti u kemm kroniċi, fil-linji taċ-ċelluli limfoblastojdi, limfoċiti periferali tad-demm u monoċiti/makrofaġi.
English: St. John's wort must not be used concomitantly with nelfinavir.
Maltese: John's wort, u jista' jkun hemm bżonn ta' aġġustament fiddoża ta' nelfinavir.
English: Resistance: Viral escape from nelfinavir can occure via viral protease mutations at amino acid positions 30, 88 and 90.
Maltese: Jista' jkun hemm ħelsien virali minn nelfinavir permezz ta' mutazzjonijiet tal-protease virali fil-pożizzjonijiet 30, 88 u 90 ta' l-aċidi amminiċi.
English: Simvastatin or lovastatin(Nelfinavir 1250 mg bid)
Maltese: Simvastatin jew lovastatin (Nelfinavir 1250 mg bid)
English: Simvastatin or lovastatin (Nelfinavir 1250 mg bid)
Maltese: Simvastatin jew lovastatin(Nelfinavir 1250 mg bid)
English: Contraceptives with ethinyl estradiol should not be coadministered with nelfinavir.
Maltese: Kontraċettivi li fihom ethinyl estradiol m'għandhomx jingħataw flimkien ma' nelfinavir.
English: 10.0 mg of sucrose palmitate,
Maltese: - Fiħ sucrose palmitate: 10.0
English: However, based on data from products known to prolong the QT-interval, a block of hERG potassium channels of > 20 % may be clinically relevant.
Maltese: Madankollu, ibbażat fuq informazzjoni minn prodotti li huma magħrufa li jtawwlu l-intervall tal-QT, imblokk ta' l-hERG ta' > 20 % jista' jkun klinikament rilevanti.
English: Nelfinavir is also an inhibitor of CYP 3A4.
Maltese: Nelfinavir huwa wkoll inibitur ta' CYP 3A4.
English: Study APV30002 is a randomised, open-label trial of 649 antiretroviral treatment naïve patients with advanced HIV-disease, investigating fosamprenavir/ritonavir (1400 mg/200 mg QD n=322) compared to nelfinavir (1250 mg BID n=327), each in combination with lamivudine (150 mg twice daily) and abacavir (300 mg twice daily).
Maltese: Studju APV30002 huwa prova randomised, open-label b'649 pazjent ġodda għal terapja antiretrovirali b'marda ta' l-HIV avvanzata, li nvestiga fosamprenavir/ritonavir (1400 mg/200 mg QD n=322) mqabbel ma' nelfinavir (1250mg BID n=327), kull wieħed f'taħlita ma' lamivudine (150 mg darbtejn kuljum) u abacavir (300 mg darbtejn kuljum).
English: Proportion of patients with HIV RNA below LOQ (sensitive and ultrasensitive assays) at Week 48 Assay
Maltese: Proporzjon ta' pazjenti b'RNA ta'-HIV taħt LOQ (analiżi sensittiva u ultrasensittiva) f'Ġimgħa 48 Analiżi
English: Increase in Nelfinavir AUC, Cmax and Tmax in Fed Low Fat (20%) versus High fat (50%) State Relative to Fasted State Following 1250 mg VIRACEPT (5 x 250 mg tablets) Number of
Maltese: Ikel bi Ftit Xaħam (20 %) kontra Ħafna xaħam (50 %) Relattiv għal Stat Sajjem Wara 1250 mg VIRACEPT (5 pilloli ta' 250 mg) Numru ta'
English: which is an ester, theoretically corresponds to maximally 5.9 mg of sucrose when fully - Contains aspartame (E951): 20.0 mg of aspartame per gram of oral powder.
Maltese: 10.0 mg ta' sucrose palmitate, li huwa ester, tejoretikament jikkorrispondi għall-massimu ta' 5.9 mg ta' sucrose meta jiġi idrolizzat - Fiħ aspartame (E951): 20.0
English: Dose to be given two times a day to children aged 3 to 13
Maltese: Tfal b'età minn 3 snin sa 13-il sena
English: At 24 weeks, the percentage of patients whose plasma HIV RNA levels had decreased to below the limit of detection of the assay (< 400 copies/ml) were 81 % and 8 % for the groups treated with nelfinavir 750 mg TID plus zidovudine and lamivudine or zidovudine and lamivudine, respectively.
Maltese: Fl-24 ġimgħa, il-perċentaġġ ta' pazjenti li l-livelli tal-plażma ta' l-RNA ta' l-HIV tagħhom kienu naqsu għal taħt il-limitu li jista' jkun osservat (< 400 kopji/ml) kien ta' 81 % u 8 % għall-gruppi ttrattati b'750 mg ta' nelfinavir TID flimkien ma' zidovudine u lamivudine, jew ma' zidovudine u lamivudine waħidhom, rispettivament.
English: Renal Impairment: Since nelfinavir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by haemodiaylisis or peritoneal dialysis.
Maltese: Indeboliment tal-kliewi: Peress li nelfinavir huwa mwaħħal ħafna mal-proteini fil-plażma, mhux probabbli li jiġi mneħħi b'mod sinifikanti b'emodijalisi jew b'dijalisi tal-peritonew.
English: Each bottle contains 144 grams of powder and is supplied with a 1 gram scoop (white) and a 5 gram scoop (blue).
Maltese: Kull flixkun fih 144 gramma ta' trab u huwa pprovdut b'kuċċarina ta' gramma waħda (bajda) u ta' 5 grammi (blu).
English: A higher risk of lipodystrophy has been associated with individual factors such as older age, and with drug related factors such as longer duration of antiretroviral treatment and associated metabolic disturbances.
Maltese: Riskju ogħla ta' lipodistrofija kien assoċjat ma' fatturi individwali bħal età avanzata u fatturi konnessi mal-mediċina bħal dewma aktar fit-tul tat-trattament antiretrovirali u disturbi metaboliċi assoċjati.
English: Hepatic impairment:
Maltese: Disturbi vaskulari:
English: AUC fold increase
Maltese: GĦAMLA KWALITATTIVA
English: • Low numbers of a type of white blood cell that fights infections (neutrophils).
Maltese: • Numru baxx ta' tip ta' ċellula bajda tad-demm li tiġġieled l-infezzjonijiet (newtrofili).
English: HIV isolates from selected patients treated with nelfinavir alone or in combination with reverse transcriptase inhibitors were monitored for phenotypic (n=19) and genotypic (n=195, 157 of which were assessable) changes in clinical trials over a period of 2 to 82 weeks.
Maltese: Iżolati ta' HIV minn pazjenti magħżula ttrattati b'nelfinavir waħdu jew flimkien ma' l-inibituri ta' reverse transcriptase kienu osservati għal tibdil fenotipiku (n=19) u ġenotipiku (n=195, li minnhom 157 setgħu jkunu assessjati) fi provi kliniċi fuq perjodu ta' 2 sa 82 ġimgħa.
English: There were no significant differences between low doses of ritonavir (either 100 or 200 mg BID) for effects on AUCs of nelfinavir and M8.
Maltese: Ma kienx hemm differenzi sinifikanti bejn dożi baxxi ta' ritonavir (100 jew 200 mg BID) għall-effetti fuq l-AUCs ta' nelfinavir u M8.
English: VIRACEPT 250 mg film-coated tablets Nelfinavir
Maltese: VIRACEPT 250 mg pilloli miksija b'rita Nelfinavir
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 events.
Maltese: Pazjenti b'epatite kronika B jew C u ttrattati b'terapija mħallta antiretrovirali huma f'riskju ikbar ta' effetti mhux mixtieqa serji u potenzjalment fatali tal-fwied.
English: Rare (≥ 0.01 % - ≤ 0.1 %): hepatitis, hepatic enzymes increased and jaundice when nelfinavir is used in combination with other antiretroviral agents.
Maltese: Rari (≥ 0.01 % - ≤ 0.1 %): epatite, żjieda ta' l-enżimi tal-fwied u suffejra meta nelfinavir jiġi wżat flimkien ma' sustanzi antiretrovirali oħra.
English: Each film-coated tablet contains 292.25 mg of nelfinavir mesilate, equivalent to 250 mg nelfinavir as free base.
Maltese: Kull pillola miksija b'rita fiha 292.25 mg ta' nelfinavir mesilate li jikkorrispondi għal 250 mg ta' nelfinavir bħala bażi libera.
English: Inhaled/nasal steroid ↑Fluticasone
Maltese: Sterojdi meħuda man-nifs/mill-imnieħer ↑Fluticasone
English: Sildenafil is contraindicated when coadministered with VIRACEPT (see contraindications).
Maltese: Sildenafil huwa kontra-indikat meta jingħata flimkien ma' VIRACEPT (ara kontraindikazzjonijiet).
English: • Low numbers of red blood cells (anaemia).
Maltese: • Numru baxx ta' ċelluli ħomor tad-demm (anemija).
English: The metabolism of pravastatin, and fluvastatin is not dependent on CYP3A4, and interactions are not expected withnelfinavir.
Maltese: Il-metaboliżmu ta' pravastatin u fluvastatin mhux dipendenti fuq CYP3A4, u mhux mistennija interazzjonijiet ma' nelfinavir.
English: Protease Inhibitors Ritonavir 500 mg single dose (nelfinavir 750 mg tid 6 days)
Maltese: Inibituri tal-Protease Ritonavir 500 mg, doża waħda (nelfinavir 750 mg tid 6 ijiem)
English: Cross resistance in vitro: HIV isolates obtained from 5 patients during nelfinavir therapy showed a 5- to 93-fold decrease in nelfinavir susceptibility in vitro when compared to matched baseline isolates but did not demonstrate a concordant decrease in susceptibility to indinavir, ritonavir, saquinavir or amprenavir in vitro.
Maltese: Iżolati ta' HIV miksuba minn 5 pazjenti waqt itterapija b'nelfinavir urew suxxettibbilità mnaqqsa (minn 5 sa 93 darba) għal nelfinavir in vitro meta mqabbla ma' iżolati tal-linja bażi li taqbel iżda ma wrewx tnaqqis li jaqbel fis-suxxettibbilità għal indinavir, għal ritonavir, għal saquinavir jew għal amprenavir in vitro.
English: The adverse reaction profile seen during paediatric clinical trials was similar to that for adults.
Maltese: Il-profil ta' reazzjonijiet avversi osservat waqt il-provi kliniċi pedjatriċi kien simili għal dak ta' l-adulti.
English: Indinavir 800 mg Q8H X 7 days (nelfinavir 750 mg single dose)
Maltese: Indinavir 800 mg Q8H X 7 ijiem (nelfinavir 750 mg, doża waħda)
English: Excipients: VIRACEPT oral powder contains aspartame (E951) as a sweetening agent.
Maltese: VIRACEPT trab orali fih aspartame (E951) bħala sustaanza li tagħti togħma ħelwa.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterium infections, and Pneumocystis carinii pneumonia.
Maltese: Eżempji rilevanti huma retinite kkawżata minn cytomegalovirus, infezzjonijiet ġeneralizzati u/jew lokalizzati b'mycobacterium, u pnewmonja kkawżata minn Pneumocystis carinii.
English: An HIV isolate obtained from a patient receiving saquinavir therapy showed decreased susceptibility to saquinavir (7- fold) but did not demonstrate a concordant decrease in susceptibility to nelfinavir.
Maltese: Iżolat ta' HIV miksub minn pazjent li kien qed jirċievi tterapjija ta' saquinavir wera suxxettibbilità mnaqqsa għal saquinavir (7 darbiet) iżda ma weriex tnaqqis li jaqbel fis-suxxettibbilità għal nelfinavir.
English: Efavirenz AUC ↔
Maltese: AKTAR TAGĦRIF
English: Also contains sweetener aspartame (E951), sucrose palmitate, potassium, natural and artificial flavourings and other constituents.
Maltese: Fih ukoll aspartame (E951) bħala sustanza li tagħti togħma ħelwa, sucrose palmitate, potassium, benna naturali u artifiċjali u kostitwenti oħra.
English: VIRACEPT should not be co-administered with omeprazole due to a reduction in exposure to nelfinavir and its active metabolite M8 (Tert-butyl hydroxy nelfinavir).
Maltese: VIRACEPT m'għandux jingħata flimkien ma' omeprazole minħabba tnaqqis fl-espożizzjoni għal nelfinavir u l-metabolit attiv tiegħu M8 (Tert-butyl hydroxy nelfinavir).
English: • Once the tablet is dispersed, mix the cloudy bluish liquid thoroughly and take immediately.
Maltese: • Ladarba l-pillola tinħall, ħawwad il-likwidu blu imdardar sewwa u ħudu minnufih.
English: Alternative contraceptive measures should be considered.
Maltese: Għandhom jiġu kkunsidrati miżuri kontraċettivi alternattivi.
English: Small, non-statistically significant differences were observed in other pharmacokinetic parameters with no trend favouring one regimen over the other.
Maltese: Differenzi żgħar u mhux statistikament sinifikanti kienu osservati f'parametri farmakokinetiċi oħra u ma kien hemm l-ebda tendenza li tiffavorixxi kors wieħed fuq l-ieħor.
English: Medicinal product by therapeutic areas (dose of nelfinavir used in study)
Maltese: Prodott mediċinali skond l-erja terapewtika (doża ta' nelfinavir użata fl-istudju)
English: Norethindrone AUC ↓18% Nelfinavir concentrations not measured
Maltese: AUC ta' norethindrone ↓18 % Konċentrazzjonijiet ta' nelfinavir mhux imkejjla
English: VIRACEPT 250 mg film-coated tablets:
Maltese: VIRACEPT 250 mg pilloli miksija b'rita:
English: The metabolism of pravastatinand fluvastatinis not dependent on CYP3A4, and interactions are not expected with nelfinavir.
Maltese: Il-metaboliżmu ta' pravastatin ufluvastatin mhux dipendenti fuq CYP3A4, u mhux mistennija interazzjonijiet ma' nelfinavir.
English: HOW TO STORE VIRACEPT
Maltese: X'inhu Viracept
English: Inhaled/nasal steroid Fluticasone
Maltese: Disturbi gastro-intestinali
English: Ritonavir 100 mg or 200 mg BID (nelfinavir 1250 mg BID evening administration)
Maltese: Ritonavir 100 mg jew 200 mg BID (nelfinavir 1250 mg BID għoti fil-għaxija)
English: Do not take Viracept if:
Maltese: Tieħux Viracept jekk:
English: The effects of nelfinavir (alone or combined with other antiretroviral agents) on biological markers of disease activity, CD4 cell count and viral RNA, were evaluated in several studies involving HIV-1 infected patients.
Maltese: L-effetti ta' nelfinavir (waħdu jew flimkien ma' mediċini antitretrovirali oħra) fuq il-markaturi bijoloġiċi ta' l-attività tal-marda, l-għadd taċ-ċelluli CD4 u l-RNA virali, kienu evalwati f'diversi studji li kienu jinvolvu pazjenti infettati bl-HIV-1.
English: Rare (affect less than 1 in 1000 people):
Maltese: Rari (jaffettwaw inqas minn persuna waħda minn kull 1000):
English: Indinavir 800 mg single dose (nelfinavir 750 mg TID X 7 days)
Maltese: Indinavir 800 mg, doża waħda (nelfinavir 750 mg TID X 7 ijiem)
English: VIRACEPT is indicated in antiretroviral combination treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children of 3 years of age and older.
Maltese: VIRACEPT huwa indikat fit-terapija mħallta antiretrovirali għat-trattament ta' adulti, adoloxxenti u tfal li għandhom aktar minn 3 snin, infettati bil-vajrus uman ta' l-immunodefiċjenza (HIV-1).
English: Vascular disorders: Rare (≥ 0.01 % - ≤ 0.1 %): increased spontaneous haemorrhage bleeding in patients with haemophilia.
Maltese: Rari (≥ 0.01 % - ≤ 0.1 %): żjieda ta' fsada spontanja f'pazjenti bl-emofilja.
English: This can lead to an increased risk of many types of infections.
Maltese: Dan jista' jwassal għall-riskju akbar ta' ħafna tipi ta' infezzjonijiet.
English: Through 48 weeks of therapy, a statistically significantly higher proportion of patients in the lopinavir/ritonavir arm had HIV-1 RNA < 50 copies/ml compared to the nelfinavir arm.
Maltese: Matul it-48 ġimgħa ta' terapija, proporzjoni statistikament sinifikanti għola ta' pazjenti fil-grupp b'lopinavir/ritonavir kellhom RNA ta' HIV-1 ta' < 50 kopja/ml meta mqabbel mal-grupp b'nelfinavir.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1, dated 30 July 2007 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Maltese: L-MAH jikkommetti li jwettaq l-attivitajiet ta' farmakoviġilanza ddettaljati fil-Pjan ta' Farmakoviġilanza kif miftiehem f'verżjoni 1, datata 30 ta' Lulju 2007 tal-Pjan għall-Immaniġġjar tarRiskju (RMP) ippreżentat f'Module 1.8.2 ta' l-Applikazzjoni għat-Tqegħid fis-Suq u kull aġġornament ta' l-RMP kif miftiehem mas-CHMP.
English: Plasma levels of nelfinavir can be reduced by concomitant use of the herbal preparation St. John's wort (Hypericum perforatum).
Maltese: John's wort (Hypericum perforatum).
English: Patients aged 3 to 13 years: for children, the recommended starting dose is 50-55 mg/kg BID or if using a TID regimen, 25 - 35 mg/kg body weight per dose.
Maltese: Pazjenti b'età minn 3 snin sa 13-il sena: għat-tfal, id-doża rrakkomandata tal-bidu hija ta' 50-55 mg/kg BID jew jekk qed tuża l-kors TID, 25 - 35 mg/kg ta' piż tal-ġisem kull doża.