FrancophonIA/ELRC3.0 huggingface dataset:
English: • This medicine contains aspartame, which is a source of phenylalanine.
Maltese: • Din il-mediċina fiha aspartame, li huwa sorsi ta' phenylalanine.
English: Sedatives/Anxiolytics Midazolam
Maltese: Sedattivi/Sustanzi kontra l-ansjetà Midazolam
English: This belongs to a group of medicines called ‘anti-retrovirals'.
Maltese: Jagħmel parti minn grupp ta' mediċini msejjħa ‘anti-retrovirali'.
English: • Pimozide (used for mental health problems)
Maltese: • Pimozide (użat għall-problemi ta' saħħa mentali)
English: ↑ Indicates increase, ↓ indicates decrease, ↔ indicates minimal change (< 10 %)
Maltese: ↑ Tindika żjieda, ↓ tindika tnaqqis, ↔ tindika bidla minima (< 10 %).
English: • The active substance in Viracept is nelfinavir.
Maltese: • Is-sustanza attiva f'Viracept hija nelfinavir.
English: LOCF= Last observation carried forward ITT = Intention to Treat NC = F: non-completers = failures
Maltese: LOCF= L-aħħar osservazzjoni carried forward ITT =Intenzjoni li jrid isir it-trattament NC = F: dawl li ma komplewx = falliment
English: Rare (≥ 0.01 % - ≤ 0.1 %): abdominal distension,
Maltese: Rari (≥ 0.01 % - ≤ 0.1 %): nefħa addominali,
English: • Terfenadine or astemizole (for allergy)
Maltese: • Terfenadine jew astemizole (għall-allerġija)
English: VIRACEPT oral powder contains potassium.
Maltese: VIRACEPT trab orali fih potassium.
English: Malta (See United Kingdom)
Maltese: Malta (Ara Renju Unit)
English: 8 g 10 g 12 g 14 g 16 g 18 g 21 g 25 g
Maltese: 10 g 12 g 14 g 16 g 18 g 21 g 25 g
English: • Immunosuppressant medicines such as tacrolimus or ciclosporin
Maltese: • Mediċini immunosoppressivi bħal tacrolimus jew ciclosporin
English: Table 2: Incidences of Adverse Reactions and marked laboratory abnormalities from the phase
Maltese: Tabella 2: Inċidenza ta' Reazzjonijiet Avversi u anormalitajiet sinifikanti tal-laboratorju minn studji ta' fażi
English: Efavirenz AUC ↔ Nelfinavir AUC ↓ 20 %
Maltese: AUC ta' efavirenz ↔ AUC ta' nelfinavir ↓ 20 %
English: DATE OF REVISION OF THE TEXT
Maltese: TalProtokol
English: INFORMATION IN BRAILLE viracept 50 mg
Maltese: INFORMAZZJONI BIL-BRAILLE viracept 50 mg
English: In patients, the nelfinavir AUC0-24 with 1250 mg BID administration was 52.8 ± 15.7 µg⋅h/ml (n=10) and with 750 mg TID administration was 43.6 ± 17.8 µg⋅h/ml (n=11).
Maltese: BID ta' 1250 mg kien ta' 52.8 ± 15.7 µg⋅h/ml (n=10) u bl-għoti ta' 750 mg TID kien ta' 43.6 ± 17.8 µg⋅h/ml (n=11).
English: Nelfinavir demonstrated additive to synergistic effects against HIV in combination with reverse transcriptase inhibitors zidovudine (ZDV), lamivudine (3TC), didanosine (ddI), zalcitabine (ddC) and stavudine (d4T) without enhanced cytotoxicity.
Maltese: Nelfinavir wera effetti minn addittivi sa sinerġetiċi kontra l-HIV flimkien ma' l-inibituri ta' reverse transcriptase ta' zidovudine (ZDV), lamivudine (3TC), didanosine (ddI), zalcitabine (ddC), u stavudine (d4T) mingħajr żjieda fiċċitotossiċità.
English: • Colchicine (for gout-flares or Mediterranean fever)
Maltese: • Colchicine (għall-irkadar tal-gotta jew deni Mediterranju)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 January 1998
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 22 ta' Jannar 1998
English: The oral powder contains: - microcrystalline cellulose - maltodextrin - dibasic potassium phosphate - crospovidone - hydroxypropyl methylcellulose - aspartame (E951) - sucrose palmitate - natural and artificial flavour
Maltese: It-trab orali fih: - microcrystalline cellulose - maltodextrin - dibasic potassium phosphate - crospovidone - hydroxypropyl methylcellulose - aspartame (E951)
English: Indigo carmine (E132) as powder.
Maltese: Magnesium stearate, Indigo carmine (E132) bħala trab.
English: (Very common (≥ 10 %); common (≥ 1 % and < 10 %) Body System
Maltese: (Komuni ħafna (≥ 10 %); komuni (≥ 1 % u < 10 %)) Sistema tal-ġisem Frekwenza tar-Reazzjoni
English: The overall incidence of other mutations associated with primary PI resistance was 9.6 % for the L90M substitution where as substitutions at 48, 82 and 84 were not observed.
Maltese: L-inċidenza totali ta' mutazzjonijiet oħra assoċjati ma' reżistenza primarja ta' PI kienet ta' 9.6 % għas-sostituzzjoni L90M filwaqt li ma kinux osservati sostituzzjonijiet f'pożizzjonijiet 48, 82 u 84.
English: The virological failure was greater in the nelfinavir group (17 %) than in the fosamprenavir/ritonavir group (7 %).
Maltese: Il-falliment viroloġiku kien akbar filgrupp b'nelfinavir (17 %) milli fil-grupp b'fosamprenavir/ritonavir (7 %).
English: • Ketoconazole, itraconazole or fluconazole (for fungal infections)
Maltese: • Ketoconazole, itraconazole jew fluconazole (għall-infezzjonjiet ikkawżati mill-moffa)
English: Clinical experience in pregnant women is limited.
Maltese: Esperjenza klinika f'nisa tqal hija limitata.
English: • Methadone (for drug dependence)
Maltese: • Methadone (għad-dipendenza mill-mediċini)
English: • Allergic reactions.
Maltese: • Reazzjonijiet allerġiċi.
English: Treatment emergent NRTI resistance was significantly less frequent with fosamprenavir/ritonavir compared to nelfinavir (13 % versus 57 %; p<0.001).
Maltese: Reżistenza għal NRTI li dehret mal-kura kienet sinifikatament inqas b'fosamprenavir/ritonavir meta mqabbel ma' nelfinavir (13 % kontra 57 %; p<0.001).
English: Cmax fold increase Increase in Tmax (hr)
Maltese: Żjieda f'Tmax (hr)
English: • Rifabutin, erythromycin or clarithromycin (for bacterial infections)
Maltese: • Rifabutin, erythromycin jew clarithromycin (għall-infezzjonijiet ikkawżati mill-batterja)
English: Metabolism: In vitro studies demonstrated that multiple cytochrome P-450 isoforms including CYP3A, CYP2C19/C9 and CYP2D6 are responsible for the metabolism of nelfinavir.
Maltese: Studji in vitro wrew li bosta isoformi taċ-ċitokromju P-450 inkluż CYP3A, CYP2C19/C9 u CYP2D6 huma responsabbli għall-metaboliżmu ta' nelfinavir.
English: • Alfuzosin (for benign prostatic hyperplasia (BPH))
Maltese: • Alfuzosin (għall-iperplasija beninna tal-prostata (BPH)
English: • This medicine is essentially ‘potassium-free' as it contains less than 1 mmol (39 milligrams) of potassium per dose.
Maltese: • Din il-mediċina hija essenzjalment ‘mingħajr potassium' peress li fiha inqas minn 1 mmol (39 milligramma) ta' potassium f'kull doża.
English: 12 to 14 kg*
Maltese: sa 12-il kg*
English: Children with weights between 10.5-12 kg, 12-14 kg and 18-22 kg will receive a different number of tablets with each meal.
Maltese: 12 kg, 12-14 kg u 18-22 kg se jirċievu numru differenti ta' pilloli ma' kull ikla.
English: Clinically significant interactions have not been observed between nelfinavir and nucleoside analogues.
Maltese: Ma ġewx osservati interazzjonijiet ta' sinifikanza klinika bejn nelfinavir u l-analogi ta' nucleoside.
English: Analgesics
Maltese: Analġeżiċi
English: Viracept is used with other ‘anti-retroviral' medicines to:
Maltese: Viracept jintuża flimkien ma' mediċini ‘anti-retrovirali' oħra biex:
English: • This medicine contains sucrose, which is a type of sugar.
Maltese: • Din il-mediċina fiha sucrose, li huwa tip ta' zokkor.
English: Ritonavir 500 mg BID, 3 doses (nelfinavir 750 single dose)
Maltese: Ritonavir 500 mg BID, 3 dożi (nelfinavir 750, doża waħda)
English: • Any other medicines for HIV infection such as ritonavir, indinavir, saquinavir and delavirdine,
Maltese: • Xi mediċina oħra għall-infezzjoni ta' l-HIV bħal ritonavir, indinavir, saquinavir u delavirdine,
English: St. John's wort, stop St. John's wort, check viral levels and if possible nelfinavir levels.
Maltese: John's wort, iċċekkja l-livelli virali u jekk possibli l-livelli ta' nelfinavir.
English: A total of approximately 400 patients received nelfinavir in paediatric treatment trials (Studies 524, 556, PACTG 377/725, and PENTA-7) for up to 96 weeks.
Maltese: Total ta' madwar 400 pazjent irċevew nelfinavir fi provi ta' kura pedjatrika (Studji 524, 556, PACTG 377/725, u PENTA-7) għal mhux aktar minn 96 ġimgħa.
English: • There have been rare reports of muscle pain, tenderness or weakness, particularly with combination anti-retroviral therapy including protease inhibitors and nucleoside analogues.
Maltese: • Kien hemm rapporti rari ta' uġigħ fil-muskoli, sensittività jew dgħjufija, speċjalment b'terapija anti-retrovirali kombinata inkluż inibituri ta' protease u analogi ta' nucleoside.
English: The major oxidative metabolite, M8 (tertbutyl hydroxy nelfinavir), has in vitro antiviral activity equal to the parent drug and its formation is catalysed by the polymorphic cytochrome CYP2C19.
Maltese: Il-metabolit ossidattiv maġġuri, M8 (tert-butyl hydroxy nelfinavir), għandu attività antivirali in vitro daqs il-mediċina oriġinali u l-formazzjoni tiegħu hija katalizzata miċ-ċitokromju polimorfiku CYP2C19.
English: M8 metabolite AUC ↑ 86%
Maltese: AUC ta' nelfinavir ↑ 39 % M8 metabolite AUC ↑ 86 %
English: Nelfinavir AUC ↑ 30%
Maltese: mhux imkejjla AUC ta' nelfinavir ↑ 30 %
English: Number of scoops Blue Scoop
Maltese: Numru ta' kuċċarini Kuċċarina Blu
English: • You have kidney problems.
Maltese: • Għandek problemi fil-kliewi.
English: Herbal Products St. John's wort
Maltese: John's wort
English: • Phenobarbital or carbamazepine (for fits or epilepsy)
Maltese: • Phenobarbital jew carbamazepine (għall-aċċessjonijiet jew epilessija)
English: Effects on drug levels % Change
Maltese: Effetti fuq il-livelli tal-mediċina % ta' Bidla
English: About 400 children (aged from 0 to 13 years) received Viracept in clinical trials.
Maltese: Madwar 400 tifel/a (b'età minn 0 sa 13-il sena) irċevew Viracept fi provi kliniċi.
English: Median baseline HIV-1 RNA was 4.98 log10 copies/ml and 5.01 log10 copies/ml in the nelfinavir and lopinavir/ritonavir treatment groups respectively.
Maltese: Medjan tal-RNA ta' HIV-1 RNA fil-linja bażi kien ta' 4.98 log10 kopji/ml u 5.01 log10 kopji/ml fil-gruppi ta' kura b'nelfinavir u lopinavir/ritonavir rispettivament.
English: H1 Receptor Antagonists, 5-HT Agonists Terfenadine, astemizole, cisapride Nelfinavir increases terfenadine
Maltese: Antagonisti tar-riċettur H1, agonisti 5-HT Terfenadine, astemizole, cisapride konċentrazzjonijiet ta' terfenadine fil-plażma.
English: Median baseline CD4+ cell counts were 177 and 166 x106 cells/l for the nelfinavir and fosamprenavir/ritonavir groups respectively.
Maltese: Medjan ta' l-għadd taċ-ċelluli CD4+ fil-linja bażi kien ta' 177 u 166 x106 cellula/l għall-gruppi b'nelfinavir u b'fosamprenavir/ritonavir rispettivament.
English: • Sildenafil (for pulmonary arterial hypertension (PAH))
Maltese: • Sildenafil (għall-pressjoni pulmonari arterjali għolja (PAH)
English: A second study evaluated the steady state pharmacokinetics of nelfinavir (1250 mg twice daily for 2 weeks) in adult HIV-seronegative subjects with mild (Child-Pugh A; n=6) or moderate (Child-Pugh B; n=6) hepatic impairment.
Maltese: Studju ieħor evalwa l-farmakokinetika fi stat fiss ta' nelfinavir (1250 mg darbtejn kuljum għal ġimagħtejn) f'individwi adulti seronegattivi għal HIV b'indeboliment tal-fwied ħafif (Child-Pugh A; n=6) jew moderat (Child-Pugh B; n=6).
English: Methadone 80 mg + 21 mg qd > 1 month (Nelfinavir 1250mg bid x 8 days
Maltese: Methadone 80 mg + 21 mg qd > xahar (Nelfinavir 1250mg bid x 8 ijiem
English: One or more viral protease mutations at amino acid positions 30, 35, 36, 46, 71, 77 and 88 were detected in > 10 % of patients with assessable isolates.
Maltese: Bidla waħda jew iżjed bidliet fi protease virali fil-pożizzjonijiet ta' l-aċidu amminiku 30, 35, 36, 46, 71, 77 u 88 kienu osservati f' > 10 % tal-pazjenti b'iżolati li setgħu jkunu assessjati.
English: Oral Contraceptives 17 α-Ethinyl estradiol 35 μg qd x 15 days (Nelfinavir 750 mg q8h x 7 days)
Maltese: Orali 17 α-Ethinyl estradiol 35 µg qd x 15-il ġurnata (Nelfinavir 750 mg q8h x 7 ijiem)
English: Roche (Hellas) A.E. Τηλ: +30 210 61 66 100
Maltese: Τηλ: +30 210 61 66 100
English: Pharmacokinetics in specialpopulations:
Maltese: Informazzjoni klinika farmakodinamika:
English: • Work against the Human Immunodeficiency Virus (HIV).
Maltese: • Jaħdem kontra l-Vajrus Uman ta' l-Immunodefiċjenza (HIV).
English: Consider alternatives that are not metabolised by CYP3A4 such as beclomethasone.
Maltese: Ikkunsidra alternattivi li mhux metabolizzati minn CYP3A4 bħal beclomethasone.
English: A connection between visceral lipomatosis and PIs and lipoatrophy and nucleoside analogue reverse transcriptase inhibitors (NRTIs) has been hypothesised.
Maltese: Konnessjoni bejn il-lipomatosi tal-vixxri u PIs u l-lipoatrofija u l-Inibituri ta' Nucleoside Analogue Reverse Transcriptase (NRTIs) kienet ipotizzata.
English: A 49 %-69 % increase was observed in AUC of nelfinavir in the hepatically impaired group (Child-Turcotte Classes A to C) compared to the healthy group.
Maltese: Żjieda ta' 49 %-69 % kienet osservata fl-AUC ta' nelfinavir fi gruppi b'mard tal-fwied (Child-Turcotte Klassijiet A sa C) meta pparagunati mal-grupp b'saħħtu.
English: Saquinavir AUC ↑ 392% Nelfinavir concentrations not measured
Maltese: AUC ta' saquinavir ↑ 392 % Konċentrazzjonijiet ta' nelfinavir
English: Elimination: oral clearance estimates after single doses (24-33 l/h) and multiple doses (26-61 l/h) indicate that nelfinavir exhibits medium to high hepatic bioavailability.
Maltese: Stimi ta' l-eliminazzjoni mill-ħalq wara dożi waħidhom (24-33 l/h) u dożi multipli (2661 l/h) jindikaw li nelfinavir juri bijo-disponibilità tal-fwied medja sa għolja.
English: The BID regimen produced statistically significantly higher peak nelfinavir plasma levels versus the TID regimen.
Maltese: Il-kors BID ipproduċa livelli massimi tal-plażma ta' nelfinavir statistikament sinifikanti meta mqabbel mal-kors TID.
English: Neutropenia/leukopenia was the most frequently observed laboratory abnormality.
Maltese: Newtropenija/lewkopenija kienet l-aktar anormalità tallaboratorju osservata b'mod komuni.
English: Nelfinavir is principally metabolised and eliminated by the liver.
Maltese: Nelfinavir huwa prinċipalment metabolizzat u eliminat mill-fwied.
English: Excipients:
Maltese: Osteonekrożi:
English: • Salmeterol (for asthma or chronic obstructive pulmonary disease (COPD)
Maltese: • Salmeterol (għall-ażżma jew marda ostruttiva kronika tal-pulmun (COPD)
English: PDE-5 inhibitors for the treatment of erectile dysfunction (ED) Tadalafil
Maltese: Inibituri ta' PDE-5 għall-kura ta' disfunzjoni erettili (ED) Tadalafil
English: Midazolam is extensively metabolised by CYP3A4.
Maltese: Midazolam huwa metabolizzat b'mod estensiv permezz ta' CYP3A4.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku ta' l-Aġenzija Ewropeja dwar il-Mediċini: http://www.ema.europa.eu/.
English: • Bosentan (for pulmonary arterial hypertension (PAH)
Maltese: • Bosentan (għall-pressjoni pulmonari arterjali għolja (PAH)
English: Norethindrone 0.4 mg qd x 15 days (Nelfinavir 750 mg q8h x 7 days)
Maltese: Norethindrone 0.4 mg qd x 15-il ġurnata (Nelfinavir 750 mg q8h x 7 ijiem)
English: • Calcium channel blockers such as bepridil (for heart problems)
Maltese: • Imblokkaturi tal-kanali tal-kalċju bħal bepridil (għall-problemi fil-qalb)
English: • Phenytoin (for fits or epilepsy)
Maltese: • Phenytoin (għall-aċċessjonijiet jew epilessija)
English: Adverse reactions from clinical trials with nelfinavir
Maltese: Reazzjonijiet avversi minn provi kliniċi b'nelfinavir
English: • The other ingredients are microcrystalline cellulose, maltodextrin, dibasic potassium phosphate, crospovidone, hydroxypropyl methylcellulose, aspartame (E951), sucrose palmitate, and natural and artificial flavour.
Maltese: • Is-sustanzi l-oħra huma microcrystalline cellulose, maltodextrin, dibasic potassium phosphate, crospovidone, hydroxypropyl methylcellulose, aspartame (E951), sucrose palmitate, u benna mmolId-Dehra ta' Viraceptu l-kontenuti tal-pakkett:
English: Pharmacotherapeutic group: direct acting antivirals, ATC code: J05AE04
Maltese: Kategorija farmakoterapewtika: antivirali li jaħdmu b'mod dirett, Kodiċi ATC:
English: No substantial differences have been observed between healthy volunteers and HIV-infected patients.
Maltese: L-ebda differenzi sostanzjali ma kienu osservati bejn voluntiera f'saħħithom u pazjenti infettati bl-HIV.
English: VIRACEPT 50 mg/g oral powder Nelfinavir
Maltese: VIRACEPT 50 mg/g trab orali Nelfinavir
English: The further degradation of M8 appears to be catalysed by CYP3A4.
Maltese: Aktar degradazzjoni ta' M8 tidher li hija kkatalizzata minn CYP3A4.
English: In subjects with normal CYP2C19 activity, plasma levels of this metabolite are approximately 25 % of the total plasma nelfinavir-related concentration.
Maltese: F'soġġetti b'attività normali ta' CYP2C19, livelli fil-plażma ta' dan ilmetabolit huma madwar 25 % tal-konċentrazzjoni totali fil-plażma relatata ma' nelfinavir.
English: Pharmacokinetic data are also available for 86 patients (age 2 to 12 years) who received VIRACEPT 25-35 mg/kg TID in Study AG1343-556.
Maltese: Tagħrif farmakokinetiku huwa disponibbli ukoll minn 86 pazjent (b'età minn sentejn sa 12-il sena) li rċevew VIRACEPT 25-35 mg/kg TID fil-Istudju AG1343-556.
English: VIRACEPT 50 mg/g oral powder
Maltese: VIRACEPT 50 mg/g trab orali
English: PDE-5 inhibitors for the treatment of pulmonary arterial hypertension (PAH) Tadalafil
Maltese: Inibituri ta' PDE-5 għall-kura ta' pressjoni pulmonari arterjali għolja (PAH) Tadalafil
English: Uncommon (≥ 0.1 % - ≤ 1 %): hypersensitivity including bronchospasm, pyrexia, pruritus, facial oedema and rash maculo-papular or dermatitis bullous.
Maltese: Mhux komuni (≥ 0.1 % - ≤ 1 %): sensittività eċċessiva inkluż bronkospażmu, deni, ħakk, edima filwiċċ u raxx makulari bl-infafet jew dermatite bulluża).
English: The pharmacokinetic data from Study AG1343-556 were more variable than data from other studies conducted in the paediatric population; the 95% confidence interval for AUC24 was 9 to 121 mg.hr/L.
Maltese: It-tagħrif farmakokinetiku minn Studju AG1343-556 kien aktar varjabbli mit-tagħrif minn studji oħra li saru fil-popolazzjoni pedjatrika; l-intervall ta' kunfidenza ta' 95 % għall-AUC24 kien ta' 9 sa 121 mg.hr/L.
English: Nelfinavir was found to be active against a broad range of laboratory strains and clinical isolates of HIV-1 and the HIV-2 strain ROD.
Maltese: Nelfinavir instab li kien attiv kontra firxa wiesgħa ta' strains tal-laboratorju u iżolati kliniċi ta' l-istrain ROD ta' l-HIV-1 u l-HIV-2.
English: The majority (87 %) of an oral 750 mg dose containing 14C-nelfinavir was recovered in the faeces; total faecal radioactivity consisted of nelfinavir (22 %) and numerous oxidative metabolites (78 %).
Maltese: Il-maġġoranza (87 %) ta' doża ta' 750 mg mill-ħalq li kien fiha l-14C-nelfinavir kienet irkuprata fl-ippurgar; ir-radjuattività totali tal-ippurgar kienet tikkonsisti f'nelfinavir (22 %) u f'metaboliti numerużi li jossidaw (78 %).
English: Acute and chronic toxicity: oral acute and chronic toxicity studies were conducted in the mouse (500 mg/kg/day), rat (up to 1,000 mg/kg/day) and monkey (up to 800 mg/kg/day).
Maltese: Studji dwar it-tossiċità akuta u kronika fil-ħalq saru fil-ġrieden (500 mg/kg/kuljum), fil-firien (sa 1,000 mg/kg/kuljum) u fix-xadini (sa 800 mg/kg/kuljum).
English: Proton Pump Inhibitors Omeprazole 20 mg bid x 4 days administered 30 minutes before nelfinavir (Nelfinavir 1250 mg bid x 4 days)
Maltese: Inibituri tal-Pompi tal-Protoni Omeprazole 20 mg bid x 4 ijiem mogħti 30 minuta qabel nelfinavir (Nelfinavir 1250 mg bid x 4 ijiem)
English: 8.5 to 10.5 kg
Maltese: 8.5 sa 10.5
English: Patients receiving VIRACEPT TID (n=11) achieved nelfinavir peak plasma concentrations (Cmax) of 3.0 ± 1.6 µg/ml and morning and evening trough concentrations of 1.4 ± 0.6 µg/ml and 1.0 ± 0.5 µg/ml, respectively.
Maltese: Pazjenti li kienu qed jirċievu VIRACEPT TID (n=11) laħqu s-Cmax ta' nelfinavir ta' 3.0 ± 1.6 µg/ml u konċentrazzjonijiet baxxi ta' filgħodu u ta' filgħaxija ta' 1.4 ± 0.6 µg/ml u ta' 1.0 ± 0.5 µg/ml, rispettivament.
English: During in vitro studies, cloned human cardiac potassium channels (hERG) were inhibited by high concentrations of nelfinavir and its active metabolite M8. hERG potassium channels were inhibited by 20 % at nelfinavir and M8 concentrations that are about four- to five-fold and seventy-fold, respectively, above the average free therapeutic levels in humans.
Maltese: Waqt studji in vitro, kanali tal-potassju kardijaċi umani kklonati (hERG) kienu inibiti b'20 % f'konċentrazzjonijiet għolja ta' nelfinavir u ta' l-M8 li huwa l-metabolit attiv li huma madwar erba' sa ħames darbiet u sebgħin darba, rispettivament, 'il fuq mill-medja tal-livelli liberi terapewtiċi filbniedem.
English: At week 48, 63 % nelfinavir and 75 % lopinavir/ritonavir patients had HIV-1 RNA < 400 copies/ml, whereas 52 % nelfinavir and 67 % lopinavir/ritonavir patients had HIV-1 RNA <50 copies/ml (intent-to-treat, missing = failure).
Maltese: Fit-48 ġimgħa, 63 % tal pazjenti b'nelfinavir u 75 % tal-pazjenti b'lopinavir/ritonavir kellhom RNA ta' HIV-1 < 400 kopja/ml, filwaqt li 52 % tal-pazjenti b'nelfinavir u 67 % tal-pazjenti b'lopinavir/ritonavir kellhom RNA ta' HIV-1 <50 kopja/ml (ħsieb biex tikkura, assenti = falliment).
English: Rare (≥ 0.01 % - ≤ 0.1 %): Blood creatine phosphokinase increased, myalgia, myositis and rhabdomyolysis have been reported with PIs, particularly in combination with nucleoside analogues.
Maltese: Rari (≥ 0.01 % - ≤ 0.1 %): Żjieda tal-creatine phosphokinase fid-demm, mijalġja, mijosite u rabdomijolisi ġeww irrapportati b'PIs, speċjalment f'taħlita ma' analogi ta' nucleoside.
English: Compared to control subjects with normal hepatic function, the AUC and Cmax of nelfinavir were not significantly different in subjects with mild impairment but were increased by 62% and 22%, respectively in subjects with moderate hepatic impairment.
Maltese: Imqabbel ma' individwi ta' kontroll b'funzjoni normali talfwied, l-AUC u Cmax ta' nelfinavir ma kienux differenti b'mod sinifikanti f'individwi b'indeboliment ħafif iżda żdiedu b'62 % u 22 %, rispettivament, f'individwi b'indeboliment moderat tal-fwied.
English: Saquinavir 1200 mg TID (nelfinavir 750 mg single dose)
Maltese: Saquinavir 1200 mg TID (nelfinavir 750 mg, doża waħda)
English: Metabolic enzyme inhibitors: Co-administration of nelfinavir with inhibitors of CYP2C19 (e.g., fluconazole, fluoxetine, paroxetine, lansoprazole, imipramine, amitriptyline and diazepam) may be expected to reduce the conversion of nelfinavir to its major active metabolite M8 (tert-butyl hydroxy nelfinavir) with a concomitant increase in plasma nelfinavir levels (see section 5.2).
Maltese: L-għoti ta' nelfinavir flimkien ma' inibituri ta' CYP2C19 (e.ż., fluconazole, fluoxetine, paroxetine, lansoprazole, imipramine, amitriptyline u diazepam) hija mistennija li tista' tnaqqas il-konverżjoni ta' nelfinavir għal metabolit attiv prinċipali M8 (tert-butyl hydroxy nelfinavir) b'żjieda fl-istess ħin tal-livelli fil-plażma ta' nelfinavir (ara sezzjoni 5.2).
English: Each tablet contains 250 mg of nelfinavir.
Maltese: Kull pillola fiha 250 mg ta' nelfinavir.
English: Study M98-863 is a randomised, double blind trial of 653 antiretroviral-naïve patients investigating lopinavir/ritonavir (400/100 mg BID n=326) compared to nelfinavir (750 mg TID n=327), each in combination with lamivudine (150 mg twice daily) and stavudine (40 mg twice daily).
Maltese: Studju M98-863 huwa prova randomised, double blind b'653 pazjent ġodda għal terapija antiretrovirali li nvestiga lopinavir/ritonavir (400/100 mg BID n=326) mqabbel ma' nelfinavir (750mg TID n=327), kull wieħed f'taħlita ma' lamivudine (150 mg darbtejn kuljum) u stavudine (40 mg darbtejn kuljum).
English: • White 1 gram (1g) scoop.
Maltese: • Kuċċarina bajda ta' ġramma waħda (1g).
English: Median baseline CD4+ cell count was 232 cells/mm3
Maltese: Medjan ta' l-għadd ta' ċelluli CD4+ fil-linja bażi kien ta' 232 ċellula/mm3 fiż-żewġ gruppi.