FrancophonIA/ELRC3.0 huggingface dataset:
English: Baseline cardiac assessment is recommended.
Maltese: Huwa rrakkomandat li jkun hemm evalwazzjoni kardijaka fil-linja bażi.
English: Median survival (months) (95% CI)
Maltese: Sopravivenza medjana (xhur) (95%CI)
English: Breast-feeding
Maltese: Kanċer tas-sider
English: Pfizer GEP, S.L.
Maltese: Icepharma hf.
English: Oesophagitis (severe:
Maltese: Mard tad-dwiefer (sever:
English: Taxespira 140 mg/7 ml concentrate for solution for infusion.
Maltese: Taxespira 140 mg/7 ml konċentrat għal soluzzjoni għall-infużjoni Docetaxel
English: However, the number of abortions increased.
Maltese: Iżda, in-numru ta' aborti żdied.
English: Patients aged 12 to 18 N=40
Maltese: Patients ta' età 12 sa 18 N=40
English: • methadone (a heroin substitute)
Maltese: • methadone (sostitut tal-eroina)
English: Avenida de Extremadura 3 09400 Aranda de Duero Burgos Spain
Maltese: Avenida de Extremadura 3 09400 Aranda de Duero Burgos Spanja
English: • The active substance is fosamprenavir.
Maltese: • Is-sustanza attiva hi fosamprenavir.
English: Stevens Johnson syndrome
Maltese: Sindromu Stevens Johnson
English: Date of renewal of authorisation: 15 May 2009.
Maltese: Data ta' tiġdid tal-awtorizzazzjoni: 15 ta' Mejju 2009.
English: Anti-fungals:
Maltese: Anti-fungali:
English: • clarithromycin, erythromycin (an antibiotic)
Maltese: • clarithromycin, erythromycin (antibijotiku)
English: ViiV Healthcare Trading Services UK Limited 12 Riverwalk,
Maltese: ViiV Healthcare UK Limited Trading Services 12 Riverwalk,
English: 6.1 List of excipients
Maltese: 6.1 Lista ta' eċcipjenti
English: (see section 4.3)
Maltese: (ara sezzjoni 4.4).
English: (cells/μl), observed analysis
Maltese: (ċelluli/μl), analiżi osservata
English: Possible ↓ or ↑ of antithrombotic effect.
Maltese: Possible ↓ jew ↑ ta' effett antitrombotiku.
English: Observed analysis
Maltese: Analiżi osservata
English: AAUCMB Mean Diff (97.5% CI)
Maltese: Differenza Medja AAUCMB (97.5% CI)
English: Patients aged 6 to 11 N=30
Maltese: Pazjenti ta' età minn 6 sa 11 N=30
English: ViiV Healthcare Trading Services UK Limited, 12 Riverwalk, Citywest Business Campus Dublin 24, Ireland
Maltese: ViiV Healthcare UK Limited Trading Services, 12 Riverwalk, Citywest Business Campus Dublin 24, Irlanda
English: Other side effects of combination therapy for HIV
Maltese: Effetti sekondarji oħra ta' terapija kombinata għal HIV
English: Contraindicated (see section 4.3).
Maltese: Kontraindikat (ara sezzjoni 4.3).
English: Ritonavir induces CYP3A4, CYP1A2, CYP2C9 and glucuronosyl transferase.
Maltese: Ritonavir jinduċi CYP3A4, CYP1A2, CYP2C9 u glucuronosyl transferase .
English: ORAL CONTRACEPTIVES Ethinyl estradiol 0.035 mg/norethisterone 0.5 mg once daily
Maltese: Ethinyl estradiol 0.035 mg/norethisterone 0.5 mg darba kuljum
English: Hertfordshire SG12 0DJ United Kingdom
Maltese: Hertfordshire SG 12 0DJ Ir-Renju Unit
English: GSS to OBT1
Maltese: GSS għal OBT1
English: United Kingdom ViiV Healthcare UK Ltd Tel: + 44 (0)800 221441 customercontactuk@gsk.com
Maltese: ViiV Healthcare UK Ltd Tel: + 44 (0)800 221441 customercontactuk@gsk.com
English: APV exposure was 25-35% lower during pregnancy.
Maltese: L-esponiment għal APV kien 25-35 % aktar baxx waqt it-tqala.
English: 1000 - 10,000 copies/ml >10,000 - 100,000 copies/ml >100,000 copies/ml FPV/RTV BID vs LPV/RTV BID
Maltese: Il-Pazjenti Kollha 1000 - 10,000 kopji/ml >10,000 - 100,000 kopji/ml >100,000 kopji/ml FPV/RTV BID vs LPV/RTV BID
English: Aspen Bad Oldesloe GmbH, Industriestrasse 32-36, D-23843, Bad Oldesloe, Germany or
Maltese: Aspen Bad Oldesloe GmbH, Industriestrasse 32-36, 23843 Bad Oldesloe, Il-Ġermanja.
English: All Patients, RD=F Analysis2
Maltese: Il-Pazjenti Kollha, Analiżi2 RD=F
English: Tricyclic antidepressant: ↑ expected
Maltese: Tricyclic antidepressant: ↑ mistennija
English: ERGOT DERIVATIVES
Maltese: DERIVATTIVI
English: Single 30 ml dose of antacid suspension (equivalent to 3.6 grams aluminium hydroxide and 1.8 grams magnesium hydroxide
Maltese: Doża waħda ta' 30 ml ta' suspensjoni ta' antiaċidu (ekwivalenti għal 3.6 grams aluminium hydroxide u 1.8 grams magnesium hydroxide
English: OPIOIDS Methadone
Maltese: OPJOJDI Methadone
English: 3 mg/kg
Maltese: Soluzzjoni 3mg/kg
English: Glaxo Operations UK Ltd (trading as GlaxoWellcome Operations), Harmire Road, Barnard Castle, Co. Durham DL12 8DT, United Kingdom or
Maltese: Glaxo Operations UK Ltd (trading as GlaxoWellcome Operations), Harmire Road, Barnard Castle, Co.
English: Amprenavir ↓ expected (CYP3A4 induction by St. John's wort)
Maltese: Amprenavir ↓ mistenni (Induzzjoni CYP3A4 minn St.John's wort)
English: Do not take Telzir:
Maltese: Tiħux Telzir:
English: Maraviroc: C12 ↑ 4.74
Maltese: C12 ↑ 4.74
English: (Increase in gastric pH)
Maltese: (Żieda fil-pH gastrika)
English: Co-administration of the antipsychotic medicinal product lurasidone and fosamprenavir/ritonavir (FPV/RTV) is contraindicated (see section 4.5).
Maltese: Amministrazzjoni aġġunta tal-prodott mediċinali antipsikotiku lurasidone and fosamprenavir/ritonavir (FPV/RTV) huwa kontroindikat (ara sezzjoni 4.5).
English: Norethisterone: Cmin ↓ 26
Maltese: Cmin ↓ 26
English: AAUCMB Observed Analysis
Maltese: Analiżi Osservata AAUCMB
English: Protease Inhibitors:
Maltese: Inibituri protease:
English: Clarithromycin: moderate ↑ expected
Maltese: Clarithromycin: ↑ moderata mistennija
English: • carbamazepine, phenobarbital, phenytoin (used to treat epilepsy)
Maltese: • carbamezapine, phenobarbital, phenytoin (użati għal kura ta' l-epilessija)
English: Median (n)
Maltese: Medjan (n)
English: ANTINEOPLASTIC AGENTS METABOLISED BY CYP3A
Maltese: METABOLIZZATI MINN CYP3A
English: • cyclosporin, rapamycin, tacrolimus (used to suppress the immune system)
Maltese: • cyclosporin, rapamycin, tacrolimus (użati biex irażżnu is-sistema immunitarja)
English: Nucleoside / Nucleotide reverse transcriptase inhibitors:
Maltese: Inibituri ta' reverse transcriptase nukleosidi/nukleotidi:
English: Dihydroergotamine: ↑ expected
Maltese: Dihydroergotamine: ↑ mistennija
English: Hypromellose Titanium dioxide (E171) Glycerol triacetate Iron oxide red (E172)
Maltese: Hypromellose Titanium dioxide (E 171) Glycerol triacetate Iron oxide aħmar (E 172)
English: Telzir 50 mg/ml oral suspension Fosamprenavir
Maltese: Telzir 50 mg/ml suspensjoni orali Fosamprenavir
English: Maraviroc: AUC12 ↑ 2.49 Maraviroc: Cmax ↑ 1.52
Maltese: AUC12 ↑ 2.49 Maraviroc:
English: Telzir is a type of medicine known as an anti-retroviral.
Maltese: Telzir huwa tip ta' mediċina magħrufa bħala anti-retrovirali.
English: Sildenafil Vardenafil Tadalafil
Maltese: INIBITURI PDE5 Sildenafil Vardenafil Tadalafil
English: • desipramine, nortriptyline, paroxetine and similar medicines (used to treat depression)
Maltese: • desipramine, nortriptyline, paroxetine u mediċini simili (użati għal kura tad-dipressjoni)
English: Amprenavir is a competitive inhibitor of the HIV-1 protease.
Maltese: amprenavir Amprenavir huwa impeditur kompetittiv tal-HIV-1 protease.
English: Amprenavir: C12 ↓ 0.64
Maltese: C12 ↓ 0.64
English: IMMUNOSUPPRESSANTS Cyclosporin
Maltese: IS-SISTEMA IMMUNI Cyclosporin Rapamycin
English: Non-nucleoside reverse transcriptase inhibitors:
Maltese: Inibituri ta' reverse transcriptase mhux nukleosidi:
English: The decrease of (R-) methadone (active enantiomer) is not expected to be clinically significant.
Maltese: It-tnaqqis ta' (R-) methadone (enantiomer attiv) mhuwiex mistenni li jkun klinikament sinifikanti.
English: Amprenavir: ↓ expected (Modest CYP3A4 induction)
Maltese: Amprenavir: ↓ mistenni (Induzzjoni modesta ta' CYP3A4)
English: • halofantrine (used to treat malaria)
Maltese: • halofantrine (użat għal kura tal-malarja)
English: No clinically significant interaction observed.
Maltese: L-ebda interazzjoni klinikament sinifikanti osservata.
English: HMG-COA REDUCTASE INHIBITORS
Maltese: INIBITURI TA' HMG-COA REDUCTASE
English: Adverse reactions are listed by MedDRA system organ class and absolute frequency.
Maltese: Ir-reazzjonijiet avversi huma elenkati skond is-sistema MedRA, klassi ta' organi u frekwenza assoluta.
English: • sildenafil, vardenafil or tadalafil (used to treat erectile dysfunction)
Maltese: • sildenafil, vardenafil jew tadalafil (użati għal kura ta' disfunzjoni erettili)
English: Amiodarone: ↑ expected Bepridil: ↑ expected Quinidine: ↑ expected
Maltese: Amiodarone: ↑ mistennija Bepridil: ↑ mistennija Quinidine: ↑ mistennija
English: ANTIRETROVIRAL MEDICINAL PRODUCTS
Maltese: PRODOTTI MEDIĊINALI
English: 18 mg/kg (0.36 ml/kg ); maximum 700 mg or 14 ml
Maltese: 33-38 kg Suspensjoni orali 18mg/kg (0.36 ml/kg ); massimu ta' 700 mg jew 14 ml
English: Telzir is supplied in plastic bottles containing 225 ml oral suspension.
Maltese: Telzir jinbiegħ fi flixken tal-plastik li fihom 225 ml ta' soluzzjoni orali.
English: Table 4 AAUCMB at Week 48 by genotypic sensitivity score in OBT and baseline resistance to FPV/RTV
Maltese: Tabella 4 AAUCMB fil-Ġimgħa 48 skont il-punteġġ ta' sensittività ġenotipika għal OBT u rreżistenza għal FPV/RTV fil-linja bażi
English: (Telzir 1400 mg single dose)
Maltese: (Telzir 1400 mg darbtejn kuljum)
English: APV geometric mean (95% CI) and Ctau values were 1.31 (0.97, 1.77), 1.34 (0.95, 1.89), and 2.03 (1.46, 2.83) µg/mL for the second trimester, third trimester, and postpartum, respectively and within the range of values in non-pregnant patients on the same FPV/RTV containing regimens.
Maltese: Il-valuri medji ġeometriċi ta' APV (95% CI) u ta' Ctau kienu 1.31 (0.97, 1.77), 1.34 (0.95, 1.89), u 2.03 (1.46, 2.83) µg/mL għattieni trimestru, it-tielet trimestru u wara t-twelid, rispettivament u fi ħdan il-medda ta' valuri f'pazjenti li ma kinux tqal fuq l-istess reġimens li kien fihom FPV/RTV.
English: You may experience muscle problems
Maltese: Tista' tesperjenza problemi fil-muskoli
English: The
Maltese: JIS
English: 400 mg/100 mg twice daily
Maltese: 400 mg/100 mg darbtejn kuljum
English: • dasatinib, nilotinib, ibrutinib, vinblastine and everolimus (used to treat several types of cancer)
Maltese: • dasatinib, nilotinib, ibrutinib, vinblastine u everolimus (użati biex jitrattaw diversi tipi ta'
English: Astemizole: ↑ expected Terfenadine: ↑ expected
Maltese: Astemizole: ↑ mistennija Terfenadine: ↑ mistennija
English: (R-) methadone: Cmax ↓ (R-) methadone: AUC ↓
Maltese: Cmax ↓ (R-) methadone:
English: Aspartate aminotransferase increased
Maltese: Żjieda f'Aspartate aminotransferase
English: Ergonovine: ↑ expected Ergotamine: ↑ expected Methylergonovine: ↑ expected
Maltese: Ergonovine: ↑ mistennija Ergotamine: ↑ mistennija Methylergonovine: ↑ mistennija
English: (Ritonavir 100 mg capsules twice daily for 7 days)
Maltese: (Kapsuli ta' Ritonavir 100 mg darbtejn kuljum għal 7 ijiem)
English: Severe and life-threatening skin reactions, including Stevens-Johnson syndrome, were reported in less than 1% of patients included in the clinical development programme.
Maltese: Reazzjonijiet fil-ġilda severi u li jipperikolaw il-ħajja, inkluża s-sindromu Stevens-Johnson, ġew rappurtati f'inqas minn 1% ta' pazjenti li ħadu sehem fil-programm ta' żvilupp kliniku.
English: The Telzir oral suspension contains propyl and methyl parahydroxybenzoate.
Maltese: Is-suspensjoni orali Telzir fiha propyl u methyl parahydroxybenzoate.
English: FPV/RTV BID - Fosamprenavir with ritonavir twice daily, LPV/RTV BID - Lopinavir / ritonavir twice daily
Maltese: FPV/RTV BID - Fosamprenavir mogħti flimkien ma' ritonavir darbtejn kuljum , LPV/RTV BID - Lopinavir / ritonavir mogħtijin darbtejn kuljum
English: All Patients CD4-count <50
Maltese: L-għadd CD4 <50
English: Rifabutin: Cmax ↓ 14%* Rifabutin: AUC(0-48) ↔*
Maltese: Rifabutin: Cmax ↓ 14%* Rifabutin:
English: Examples of antineoplastic agents: dasatinib nilotinib ibrutinib vinblastine everolimus
Maltese: dasatinib nilotinib ibrutinib vinblastine everolimus
English: Herbal preparations containing St John's wort must not be combined with Telzir (see section 4.3).
Maltese: Preparazzjonijiet erbali li fihom St John's wort m'għandhomx jiġu ikkumbinati ma' Telzir (ara sezzjoni 4.3).
English: GASTROINTESTINAL MOTILITY AGENTS
Maltese: ILMOTIILITA' GASTROINTESTINALI
English: Severe or life-threatening cases of rash, including Stevens-Johnson syndrome are rare.
Maltese: Każijiet ta' raxx severi jew li jipperikolaw il-ħajja, inkluża s-sindromu Stevens-Johnson huma rari.
English: Cyclosporin: ↑ expected Rapamycin: ↑ expected Tacrolimus: ↑ expected
Maltese: Cyclosporin: ↑ mistennija Rapamycin: ↑ mistennija Tacrolimus: ↑ mistennija
English: Week 48 AAUCMB (n)
Maltese: Ġimgħa 48 AAUCMB
English: • , , simeprevir, daclatasvir (used to treat hepatitis C virus infection)
Maltese: • simeprevir, daclatasvir (użati biex jikkuraw infezzjoni bil-virus tal-epatite Ċ)
English: Glaxo Wellcome Operations, Priory Street, Ware, Hertfordshire SG12 0DJ, United Kingdom Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero Burgos, Spain Oral suspension
Maltese: Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero Burgos, Spanja Suspensjoni
English: Capsule or Solution 100 mg
Maltese: Kapsula jew Soluzzjoni 100mg
English: Etravirine Cmin↔a Etravirine Cmax↔a a Comparison based on historic control.
Maltese: Etravirine Cmin↔a Etravirine Cmax↔a a Tqabbil ibbażat fuq kontroll fil-passat.
English: Following administration of Telzir, the half-life of amprenavir is 7.7 hours.
Maltese: Wara li jingħata Telzir, il-half-life ta' amprenavir hi ta' 7.7 sigħat.
English: The mean steady state plasma amprenavir trough concentration (Cmin) was 2.12 (1.77-2.54) µg/ml and AUC0-tau was 39.6 (34.5-45.3) h*µg/ml.
Maltese: Il-konċentrazzjoni medja fl-istat fiss ta' amprenavir fil-plażma fl aktar livell baxx kienet 2.12 (1.77-2.54) µg/ml u AUC0-tau kienet 39.6 (34.5-45.3) h*µg/ml.
English: • The other ingredients are: microcrystalline cellulose, croscarmellose sodium, povidone K30,
Maltese: Is-sustanzi l-oħra huma: microcrystalline cellulose, croscarmellose sodium, povidone K30,
English: • doses of ketoconazole and itraconazole greater than 200 mg per day (used to treat fungal infections)
Maltese: • dożi ta' ketoconazole u itraconazole akbar minn 200mg kuljum (użati għal kura ta' infezzjonijiet fungali)
English: Protect other people.
Maltese: protease.
English: One resistance mutation was observed in each of 3 isolates: K20K/R, I54I/L and I93I/L respectively
Maltese: K20K/R, I54I/L and I93I/L.
English: Table 1 Efficacy Outcome at Week 48 in ESS100732 (ART-Naïve Patients) FPV/RTV 700 mg/100 mg BID (n= 434)
Maltese: Tabella 2 Riżultat tal-Effikaċja fil-Ġimgħat 96 u 144 fl-Estensjoni ta' ESS100732 (Pażjenti mingħajr esperjenza ta' kura b'ART) FPV/RTV 700 mg/100 mg BID (n= 105)
English: ITT (Ext)
Maltese: ITT(E)
English: Hormonal contraception
Maltese: Kontraċezzjoni ormonali
English: ANTACIDS, HISTAMINE H2 RECEPTOR ANTAGONIST AND PROTON-PUMP INHIBITORS
Maltese: ISTAMINIKU H2 U INIBITURI TALPROTON-PUMP
English: Tablet or Oral suspension 700 mg (1 tablet or 14 ml suspension)
Maltese: Pillola jew Suspensjoni orali 700mg (pillola 1 jew 14ml ta' suspensjoni)
English: • fluticasone propionate and similar medicines used to treat asthma, unless considered essential.
Maltese: • fluticasone propionate u mediċini simili użati għal kura ta' l-ażma, sakemm mhux ikkonsidrat neċessarju.
English: ORAL ANTICOAGULANTS
Maltese: ANTIKOAGULANTI
English: Amprenavir and ritonavir levels may increase on stopping St John's wort.
Maltese: ritonavir l-RNA ta' HIV u waqqaf St John's wort.
English: 1000 - 10,000 copies/ml >10,000 - 100,000 copies/ml >100,000 copies/ml AAUCMB Observed Analysis
Maltese: Il-Pazjenti Kollha 1000 - 10,000 kopji/ml >10,000 - 100,000 kopji/ml >100,000 kopji/ml
English: (Induction and/or inhibition of CYP2C9 by RTV)
Maltese: (Induzzjoni u/jew inibizzjoni ta' CYP2C9 minn RTV)
English: You must take Telzir oral suspension.
Maltese: Uża s-suspensjoni orali ta' Telzir.
English: Lurasidone: ↑ expected (CYP3A4 inhibition)
Maltese: Lurasidone: ↑ mistenni (inibizzjoni ta' CYP3A4)
English: The in vitro antiviral activity observed with fosamprenavir is due to the presence of trace amounts of amprenavir.
Maltese: L-attività antivirali in vitro osservata ma' amprenavir hi dovuta għall-preżenza ta' traċċi ta' ammonti ta' amprenavir.
English: Median CD4 cells/μl CD4 count < 350 cells/μl, n (%)
Maltese: Għadd CD4 < 350 ċelluli/μl, n (%) Riżultati tal-Effikaċja
English: Anti-hepatitis C virus medicinal products
Maltese: Prodotti mediċinali kontra l-virus tal-epatite Ċ
English: Amprenavir (APV) pharmacokinetics were studied in pregnant women receiving FPV/RTV 700/100 mg twice daily during the second trimester (n=6) or third trimester (n=9) and postpartum.
Maltese: Il-farmakokinetika ta' amprenavir (APV) ġiet studjata f'nisa tqal li kienu qed jirċievu FPV/RTV 700/100 mg darbtejn kuljum waqt it-tieni trimestru (n=6) jew it-tielet trimestru (n=9) jew wara ttwelid.
English: The adverse reaction profile was similar across all the respective adult studies: antiretroviral naïve patients (APV30002, ESS100732), protease inhibitor experienced (twice daily dosing, APV30003) patients.
Maltese: Il-profil ta' reazzjonijiet avversi kien simili għall-istudji kollha rispettivi f'adulti: gruppi ta' pazjenti li m'għandhomx esperjenza ta' trattament antiretrovirali (APV30002, ESS100732) u pazjenti b'esperjenza ta' impedituri protease (doża ta' darbtejn kuljum, APV30003).
English: Anticonvulsants (carbamazepine, phenobarbital) should be used with caution.
Maltese: Mediċini anti-konvulsivi (carbamazepine, phenobarbital) għandhom jintużaw b'prekawzjoni.
English: Telzir must not be administered concurrently with medicinal products with narrow therapeutic windows that are substrates of cytochrome P450 3A4 (CYP3A4), e.g. alfuzosin, amiodarone, astemizole, bepridil, cisapride, dihydroergotamine, ergotamine, pimozide, quetiapine, quinidine, terfenadine, oral midazolam (for caution on parenterally administered midazolam, see section 4.5), oral triazolam, sildenafil used for the treatment of pulmonary arterial hypertension (for use of sildenafil in patients with erectile dysfunction, see sections 4.4 and 4.5).
Maltese: Telzir m'għandux jingħata fl-istess ħin ma' prodotti mediċinali b' therapeutic windows dojoq li huma sottostrati (substrates) ta' cytochrome P450 3A4 (CYP3A4), eż. alfuzosin, amiodarone, astemizole, bepridil, cisapride, dihydroergotamine, ergotamine, pimozide, quetiapine, quinidine, terfenadine, midazolam mill-ħalq (għal kawtela meta midazolam jingħata ġol-vini ara sezzjoni 4.5), triazolam millħalq, sildenafil użat għall-kura ta' pressjoni għolja fl-arterja pulmonari (għall-użu ta' sildenafil f'pazjenti b'disfunzjoni erettili, ara sezzjonijiet 4.4 u 4.5).
English: Other medicines and Telzir
Maltese: Mediċini oħra u Telzir
English: Flecainide: ↑ expected Propafenone: ↑ expected
Maltese: Flecainide: ↑ mistennija Propafenone: ↑ mistennija
English: INFECTION Antibacterials:
Maltese: Antibatteriċi:
English: 18 mg/kg (0.36 ml/kg )
Maltese: 25-32 kg Suspensjoni orali 18mg/kg (0.36 ml/kg )
English: 25-O-desacetylrifabutin: AUC(0-48) ↑ 11-fold* *compared to rifabutin 300 mg once daily
Maltese: AUC(0-48) ↑ 11-fold* *mqabbla ma' rifabutin 300 mg darba kuljum
English: >100,000 copies/ml, n (%)
Maltese: < 100,000 kopja/ml
English: In the Time to loss of virological response (TLOVR) analysis for the ITT(E) population, the proportion of patients achieving <400 copies/ml was 73 % (315 / 434) in the fosamprenavir with ritonavir group compared to 71 % (317 / 444) of patients receiving lopinavir / ritonavir, with a 95 % confidence interval of the difference of [-4,84%; 7;05%].
Maltese: ITT(E), il-proporzjon ta' pazjenti fil-grupp ta' fosamprenavir ma' ritonavir li laħqu <400 kopja/ml kienet 73% (315/434) meta mqabbla ma' 71% (317/444) ta' pazjenti li ngħataw lopinavir/ritonavir, b'95% intervall ta' kunfidenza tad-differenza ta' [ -4,84%; 7;05%].
English: AUC ↓ 16% (-36%; +8%) Cmin ↓ 19% (-42%; +13%)
Maltese: Cmax ↓ 14% (-36%; +15%) AUC ↓ 16% (-36%; +8%) Cmin ↓ 19% (-42%; +13%)
English: Fosamprenavir contains a sulphonamide moiety.
Maltese: Fosamprenavir fih nofs li tikkonsisti f'sulphonamide.
English: Antiretroviral Naïve Adult Patients
Maltese: Pazjenti Adulti b'Esperjenza Antiretrovirali
English: Mean (n)
Maltese: Medja (n)
English: (Study conducted in 8 patients)
Maltese: (Studju li sar fi 8 pazjenti)
English: Anti-fungals: Ketoconazole
Maltese: Ketoconazole:
English: Amprenavir: Cmax ↔ Amprenavir: AUC ↑ 20% Amprenavir: Cmin ↑ 19%
Maltese: AUC ↑ 20% Amprenavir: Cmin ↑ 19%
English: EXP
Maltese: OBT
English: Amprenavir: Cmax ↓ 13%* Amprenavir: AUC ↓ 26%* Amprenavir: Cmin ↓ 42 %* * compared to fosamprenavir / ritonavir 700 mg/100 mg twice daily
Maltese: AUC ↓ 26%* Amprenavir: Cmin ↓ 42 %* * meta mqabbla ma' fosamprenavir / ritonavir 700 mg/100 mg darbtejn kuljum
English: Fosamprenavir is converted in man to amprenavir.
Maltese: Fil-bniedem fosamprenavir jiġi mibdul f'amprenavir.
English: Fosamprenavir was not mutagenic or genotoxic in a standard battery of in vitro and in vivo assays.
Maltese: Fosamprenavir ma nstabx li kien mutaġeniku jew ġenotossiku f'analiżi in vitro u in vivo ta' standard battery.
English: Rarely, the skin rash can be severe and serious (Stevens Johnson syndrome).
Maltese: Rarament, ir-raxx fil-ġilda jista' jkun sever u serju (sindrome ta' Stevens Johnson).
English: Lopinavir: Cmax↑ 30% Lopinavir: AUC ↑ 37% Lopinavir: Cmin ↑ 52%
Maltese: Lopinavir: Cmax↑ 30% Lopinavir: AUC ↑ 37% Lopinavir:
English: Amprenavir: Cmax ↔*
Maltese: Amprenavir: Cmax ↔* Amprenavir:
English: methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216).
Maltese: propylene glycol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216)
English: No FPV/RTV drug interaction studies dasatinib: ↑ expected nilotinib: ↑ expected ibrutinib: ↑ expected vinblastine: ↑ expected everolimus: ↑ expected (CYP3A4 inhibition)
Maltese: dasatinib: ↑ mistenni nilotinib: ↑ mistenni ibrutinib: ↑ mistenni vinblastine: ↑ mistenni everolimus: ↑ mistenni (inibizzjoni ta' CYP3A4)
English: A 75 % reduction of the standard rifabutin dose (i.e. to 150 mg every other day) is recommended.
Maltese: 75 % fid-doża bażika ta' rifabutin (i.e. għal 150 mg ġurnata iva u oħra le).
English: (R-) methadone: Cmax ↓
Maltese: (R-) methadone:
English: (CYP2D6 inhibition by RTV)
Maltese: (Inibizzjoni CYP2D6 minn RTV)
English: The mean AAUCMBs (log10 c/ml) in the ITT (E) population (Observed analysis) at 48 weeks (primary end-point) and other efficacy outcomes by subgroup are described in the tables below:
Maltese: Il-medja ta' AAUCMBs (log10 c/ml) fil-grupp ITT (E) (Analiżi osservata) fit-48 ġimgħa (end-point primarju) u riżultati oħra ta' effikaċja skont is-sottogrupp huma deskritti fit-tabelli t'hawn taħt:
English: These medicines are not recommended with Telzir/ritonavir:
Maltese: Dawn il-mediċini m'humiex rakkomandati ma' Telzir/ritonavir :
English: Excipients:
Maltese: Atorvastatin:
English: (CYP3A4 induction by rifampicin)
Maltese: (Induzzjoni ta' CYP3A4 minn rifampicin)
English: Among the 81 PI-naïve paediatric patients treated with fosamprenavir / ritonavir, 15 patients met protocol-defined virological failure through 48 weeks in APV29005 and up to 108 weeks in APV20003.
Maltese: Fost il-81 pazjent pedjatriku li qatt ma ħadu PI qabel, ikkurati b'fosamprenavir/ritonavir, 15-il pazjent issodisfaw falliment viroloġiku ddefinit bi protokoll tul 48 ġimgħa f'APV29005 u sa 108 ġimgħat f'APV20003.
English: 6-17 years >39 kg Tablet or Oral suspension 700 mg (1 tablet or 14 ml suspension)
Maltese: >39 kg Pillola jew Suspensjoni orali 700mg (pillola 1 tablet jew 14ml ta' suspensjoni)
English: Administration of the fosamprenavir tablet formulation in the fed state (standardised high fat meal: 967 kcal, 67 grams fat, 33 grams protein, 58 grams carbohydrate) did not alter plasma amprenavir pharmacokinetics (Cmax, tmax or AUC0-∞) compared to the administration of this formulation in the fasted state.
Maltese: It-teħid ta' amprenavir fil-formolazzjoni ta' pillola fi stat mitmugħ (ikla standardised b'ħafna xaħam: 967 kcal, 67 gramma ta' xaħam, 33 gramma proteina, 58 gramma karboidrati) ma' bidilx ilfarmakokinetiċi ta' amprenavir fil-plażma (Cmax, Tmax jew AUC0-∞) meta mqabbel ma' t-teħid ta' din il-formolazzjoni fi stat sajjem.