FrancophonIA/ELRC3.0 huggingface dataset:
English: This means that Pemetrexed medac is similar to a ‘reference medicine' already authorised in the European Union (EU) called Alimta.
Maltese: Dan ifisser li Pemetrexed medac huwa simili għall‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem ta' Alimta.
English: It is not intended to provide practical advice on how to use Pemetrexed medac.
Maltese: Dan mhux maħsub biex jipprovdi konsultazzjoni prattika dwar l-użu ta' Pemetrexed medac.
English: Date of last renewal: 17 November 2005
Maltese: Data ta' l-aħħar tiġdid: 17 ta' Novembru 2005
English: Medicinal products - interactions
Maltese: Prodotti mediċinali - interazzjonijiet
English: (see section 4.5).
Maltese: (ara sezzjoni 4.4)
English: Antibiotics/antifungals
Maltese: Antibijotiċi/antifungals
English: • Protease inhibitors (PIs):
Maltese: ● Inibituri protease (PIs):
English: SOC PI (n = 83): Indinavir / RTV (29%) Lopinavir / RTV (36%) Saquinavir / RTV(20%)
Maltese: Indinavir / RTV (29%) Lopinavir / RTV (36%) Saquinavir / RTV(20%)
English: Median number of PI primary mutations 1
Maltese: Numru medja ta' mutazzjonijiet primarji1 PI
English: Stevens Johnson syndrome
Maltese: Is-sindromu ta' Stevens Johnson
English: • Other combinations
Maltese: • Kombinazzjonijiet oħra
English: Amprenavir is a competitive inhibitor of HIV-1 protease.
Maltese: Amprenavir huwa inibitur kompetitiv ta' l-HIV-1 protease.
English: Median CD4 (cells/ml) (range)
Maltese: Medja ta' CD4 (cells/ml) (sensiela)
English: 0.043b (−0.250, 0.335)c
Maltese: 250, 0.335)c
English: For a full list of excipients, see section 6.1.
Maltese: Għal lista sħiħa ta' sustanzi mhux attivi, ara sezzjoni 6.1.
English: • Non-nucleoside reverse transcriptase inhibitors (NNRTIs):
Maltese: ● Inibituri non-nuklejosajd rivers transkriptejż (NNRTIs):
English: Clinical experience:
Maltese: Esperjenza Klinika:
English: Elimination: the plasma elimination half-life of amprenavir ranges from 7.1 to 10.6 hours.
Maltese: Eliminazzjoni: il-half-life ta' l-eliminazzjoni ta' amprenavir mill-plażma tvarja bejn 7.1 għal 10.6 siegħat.
English: Ritonavir also inhibits CYP2D6 and induces CYP3A4, CYP1A2, CYP2C9 and glucuronosyl transferase.
Maltese: Ritonavir jinibixxi wkoll CYP2D6 u jistimola CYP3A4, CYP1A2, CYP2C9 u glucuronosyl transferase.
English: 1 Primary mutations were as defined by the IAS USA at the time of the original analysis, 2002 D30N,
Maltese: 1 Il-mutazzjonijiet primarji kienu definiti mill-IAS USA fiż-żmien ta' l-analiżi oriġinali, 2002 D30N,
English: Elevations in cholesterol were of grade 3-4 intensity.
Maltese: Żidiet fil-kolesterol kienu ta' intensità ta' grad 3-4.
English: Antiretroviral agents
Maltese: Mediċini Antiretrovirali
English: • Nucleoside analogue reverse transcriptase inhibitors (NRTIs):
Maltese: ● Analogi ta' l-Inibituri nuklejosajd rivers transkriptejż (NRTIs):
English: Very common Common Uncommon Rare
Maltese: Komuni ħafna Komuni Mhux komuni Rari
English: • Glaxo Operations UK Limited, trading as Glaxo Wellcome Operations Priory Street, Ware, Hertfordshire SG12 ODJ, United Kingdom Manufacturing authorisation issued on 30 June 1995 by the Medicine Control Agency, Market Towers, 1 Nine Elms Lane, Vauxhall, London SW8 5NQ, United Kingdom.
Maltese: • Glaxo Operations UK Limited, fil-kummerċ Glaxo Wellcome Operations Triq Priory, Ware, Hertfordshire SG12 ODJ, Renju Unit L-awtorizzazzjoni tal-manifattura ġiet maħruġa fi 30 ta' Ġunju 1995 mill-Aġenzija talKontroll tal-Mediċini, Market Towers, 1 Sqaq Nine Elms, Vauxhaull, Londra SW8 5NQ, Renju Unit.
English: • Glaxo Wellcome GmbH & Co. KG Industrie straße 32-36, 23843 Bad Oldesloe, Germany
Maltese: KG Industrie straße 32-36, 23843 Bad Oldesloe, Il-Ġermanja
English: Middlesex UB6 ONN United Kingdom
Maltese: Middlesex UB6 ONN Renju Unit
English: Excipients: d-sorbitol (E420)
Maltese: Sustanzi mhux attivi: d-sorbitol (E420)
English: (−21, 9)c a Intent To Treat (Exposed) Population: Observed analysis b Mean stratified difference c 95% confidence interval
Maltese: Analiżi osservata b Differenza medja stratifikata c 95% confidence interval
English: Anticonvulsants (carbamazepine, phenobarbital, phenytoin) should be used with caution.
Maltese: Antikonvulżivi (carbamezapine, phenobarbital, phenytoin) għandhom jintużaw b'kawtela.
English: Mean plasma HIV-1 RNA AAUCMB (log10 copies/ml)
Maltese: Medja fil-plażma ta' HIV-1 RNA AAUCMB (kopji log10/ml)
English: You should not take more than 2800 mg per
Maltese: M'għandekx tieħu 2800 mg kuljum.
English: 240 soft capsules
Maltese: 240 kapsuli rotob
English: 480 soft capsules
Maltese: 480 kapsuli rotob
English: BATCH NUMBER LOT
Maltese: NUMRU TAL-LOTT
English: Middlesex UB6 0NN United Kingdom
Maltese: Middlesex UB6 0NN Renju Unit
English: STORING AGENERASE
Maltese: Tieħux Agenerase
English: These include substances such as: clozapine, cimetidine, dapsone and loratadine.
Maltese: Dawn is-sustanzi jinkludu: clozapine, carbamazepine, cimetidine, dapsone, itraconazole u loratadine.
English: You should not take more than 2400 mg per day.
Maltese: Qatt m'għandek tieħu aktar minn 2400 mg kuljum.
English: Delavirdine: the AUC, Cmax and Cmin of delavirdine were decreased by 61%, 47% and 88% respectively when given with amprenavir.
Maltese: Delavirdine: l-AUC, Cmax u Cmin ta' delavirdine naqsu b'61%, 47% u 88% rispettivament meta ġie mogħti flimkien ma' amprenavir.
English: Agenerase oral solution contains 1 mg potassium per ml.
Maltese: Is-soluzzjoni orali ta' Agenerase fiha 1mg potassium kull ml.
English: Capsule contents: d-alpha tocopheryl polyethylene glycol 1000 succinate (TPGS), macrogol 400 (PEG 400), propylene glycol.
Maltese: Kontenut tal-kapsula: d-alpha tocopheryl polyethylene glycol 1000 succinate (TPGS), macrogol 400 (PEG 400), propylene glycol.
English: The Cmin of ethinyl estradiol was increased by 32%, whilst the AUC and Cmin of norethindrone were increased by 18% and 45% respectively.
Maltese: Cmin ta' ethinyl estradiol żdied b'32%, filwaqt li l-AUC u Cmin ta' norethindrone żdiedu b'18% u 45% rispettivament.
English: The AUC, Cmax and Cmin of amprenavir were increased by 130%, 40% and 125% respectively.
Maltese: L-AUC, Cmax u Cmin ta' amprenavir żdiedu bi 130%, 40% u 125% rispettivament.
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskolu-skeletriċi u tal-connective tissue
English: At Week 48, approximately 25 % of those enrolled had plasma HIV-1 RNA < 10,000 copies/ml and 9 % < 400 copies/ml with a median change from baseline in CD4+ cells of 26 cells/mm3 (n=74).
Maltese: F'ġimgħa 48, bejn wieħed u ieħor 25% ta' dawk irreġistrati kellhom HIV-1 RNA fil-plażma ta' <10,000 kopji/ml u 9% kellhom <400 kopji/ml b'bidla medja mill-linja bażi ta' ċelluli CD4+ ta' 26 ċellula/mm3 (n=74).
English: Fluticasone propionate (interaction with ritonavir): in a clinical study where ritonavir 100 mg capsules bid were co-administered with 50 µg intranasal fluticasone propionate (4 times daily) for 7 days in healthy subjects, the fluticasone propionate plasma levels increased significantly, whereas the intrinsic cortisol levels decreased by approximately 86 % (90 % confidence interval 82-89 %).
Maltese: Fluticasone propionate (effett ma' ritonavir): fi studju kliniku fejn kapsuli ta' ritonavir 100mg darbtejn kuljum ingħataw ma' fluticasone propionate 50μg erba' darbiet kuljum fl-imnieħer għal 7 ijiem f'suġġetti b'saħħithom, il-livelli ta' fluticasone propionate fil-plażma żdiedu b'mod sinifikanti, filwaqt li l-livelli intrinsiċi ta' cortisol naqqsu bejn wieħed u ieħor bi 86% (90% confidence interval 82-89%).
English: Tel.: + 49 (0)89 36044 8701 produkt.info@gsk.com
Maltese: KG Tel.: + 49 (0)89 36044 8701 produkt.info@gsk.com
English: Propylene glycol, macrogol 400 (PEG 400), d-alpha tocopheryl polyethylene glycol 1000 succinate, acesulfame potassium, saccharin sodium, sodium chloride, artificial grape bubblegum flavour, natural peppermint flavour, menthol, citric acid, anhydrous, sodium citrate dihydrate, purified water.
Maltese: Propylene glycol, macrogol 400 (PEG 400), d-alpha tocopheryl polyethylene glycol 1000 succinate, acesulfame potassium, saccharin sodium, sodium chloride, togħma ta' bubblegum ta' l-għeneb artifiċjali, togħma ta' peppermint naturali, menthol, citric acid, anhydrous, sodium citrate dihydrate, ilma ppurifikat.
English: Capsule shell: gelatin, glycerol, d-sorbitol (E420) and sorbitans solution, titanium dioxide, red printing ink.
Maltese: Qoxra tal-kapsula: gelatin, glycerol, taħlita likwida ta' d-sorbitol (E420) u sorbitans, titanium dioxide, red printing ink.
English: Lopinavir / ritonavir (Kaletra): in an open-label, non-fasting pharmacokinetic study, the AUC, Cmax and Cmin of lopinavir were decreased by 38%, 28% and 52% respectively when amprenavir (750 mg twice daily) was given in combination with Kaletra (400 mg lopinavir + 100 mg ritonavir twice daily).
Maltese: Lopinavir / ritonavir (Kaletra): Fi studju li sar (studju farmakokinetiku tat-tip open-label u li sar f'nies li ma kienux qed isumu) l-AUC, Cmin u Cmax ta' lopinavir naqsu bi 38%, 28% u 52% rispettivament meta amprenavir (750 mg darbtejn kuljum) ġie mogħti flimkien ma' Kaletra (400 mg lopinavir u 100 mg ritonavir darbtejn kuljum).
English: The usual dose of Agenerase oral solution is 17 mg (1.1 ml) for each kg of body weight three times a day.
Maltese: Id-doża rakkomandata ta' soluzzjoni orali ta' Agenerase hija ta' 17 mg (1.1 ml) kull kilogramm tliet darbiet kuljum.
English: The Cmax of amprenavir was decreased by 14 % whilst the AUC and Cmin were increased by 9 % and 189 %, respectively.
Maltese: Is-Cmax ta' amprenavir naqas b'14%, filwaqt li l-AUC u Cmin żdiedu b'9% u 189% rispettivament.
English: EU/1/00/148/002 EU/1/00/148/003
Maltese: EU/1/00/148/003
English: • A severe or life-threatening skin reaction (Stevens Johnson syndrome)
Maltese: • Reazzjoni fil-ġilda qawwija jew ta' periklu għall-ħajja (sindromu ta' Stevens Johnson)
English: The in vitro antiviral activity of amprenavir was evaluated against HIV-1 IIIB in both acutely and chronically infected lymphoblastic cell lines (MT-4, CEM-CCRF, H9) and in peripheral blood lymphocytes.
Maltese: L-attività antivirali in vitro ta' amprenavir ġiet valutata ma' l-HIV-1 IIIB f'razzez ta' ċelluli limfoblastiċi infettati b'mod akut u b'mod kroniku (MT-4, CEM-CCRF,H9) u f'limfoċiti periferali tad-demm.
English: The mean AUC over a dosing interval of 12 hours is 18.46 μg.h/ml (3.0232.95).
Maltese: Il-valur intermedju talAUC fuq perjodu ta' 12-il siegħa huwa ta' 18.46 µg.h/ml (3.02-32.95).
English: Fatigue
Maltese: Lott
English: Sixteen of 434 ART-naïve patients who received fosamprenavir 700mg/ritonavir 100mg twice daily in ESS100732 experienced virological failure by Week 48 with 14 isolates genotyped.
Maltese: Sittax mill-434 pazjent mingħajr esperjenza ART li ngħataw fosamprenavir 700mg/ritonavir 100mg darbtejn kuljum f'ESS100732 esperjenzaw falliment viroloġiku sa Ġimgħa 48 b'14-il iżolat ġenotipat.
English: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Maltese: Pazjenti bi problemi rari ereditarji ta' intolleranza ta' fructose m'għandhomx jieħdu din il-mediċina.
English: Analyses based on phenotypic resistance testing.
Maltese: Analiżi bbażata fuq testijiet ta' reżistenza fenotipika
English: Baseline characteristics Median HIV-1 RNA (log10 copies/ml) (range)
Maltese: Medja ta' HIV-1 RNA (kopji log10 /ml) (sensiela)
English: In the same study, the AUC, Cmax, and Cmin of amprenavir were increased 72%, 12%, and 483%, respectively, when compared to values after standard doses of amprenavir (1200 mg twice daily).
Maltese: Fl-istess studju, l-AUC, Cmin u Cmax ta' amprenavir żdiedu b'72%, 12% u 483% rispettivament meta mqabbla ma' valuri milħuqa wara doża normali ta' amprenavir (1200 mg darbtejn kuljum).
English: Bottle contents : 240 ml oral solution containing 15 mg/ml amprenavir A 20 ml measuring cup is provided in the pack.
Maltese: Il-flixkun fih : 240 ml ta' soluzzjoni orali li fiha 15 mg/ml ta' amprenavir Fil-pakkett għandek issib tazza tal-kejl ta' 20 ml.
English: Steroids: oestrogens and progestogens may interact with amprenavir.
Maltese: Sterojdi: oestrogens u progestogens jistgħu ma jkunux jaqblu ma' amprenavir.
English: Methadone and opiate derivatives: co-administration of methadone with amprenavir resulted in a decrease in the Cmax and AUC of the active methadone enantiomer (R-enantiomer) of 25% and 13% respectively, whilst the Cmax, AUC and Cmin of the inactive methadone enantiomer (S-enantiomer) were decreased by 48%, 40% and 23% respectively.
Maltese: Methadone u derivati opiate: meta ġie mogħti methadone flimkien ma' amprenavir kien hemm nuqqas fis-Cmax u AUC ta' l-active methadone enantiomer (R-enantiomer) ta' 25% u 13% rispettivament, filwaqt li Cmax , AUC u Cmin ta' l-inactive methadone enantiomer (S-enantiomer) naqsu b'48%, b'40% u bi 23% rispettivament.
English: In the studies of PI-experienced patients, PRO30017 (amprenavir 600 mg / ritonavir 100 mg twice daily in sub-study A and B with 80 and 37 patients respectively), the following mutations emerged in patients with virological failure: L10F/I/V, V11I, I13V, K20R, V32I, L33F, E34Q, M36I, M46I/L, I47V, G48V, I50V, I54L/M/T/V, Q58E, D60E, I62V, A71V, V77I, V82A/I, I84V, I85V, L90M and I93L/M.
Maltese: Fl-istudji ta' pazjenti b'esperjenza-PI, PRO30017 (amprenavir 600mg/ritonavir 100mg darbtejn kuljum f'sub-studju A u B bi 80 u 37 pazjent rispettivament), ħarġu dawn il-mutazzjonijiet f'pazjenti b'falliment viroloġiku : L10F/I/V, V11I, I13V, K20R,V32I, L33F, E34Q, M36I, M46I/L, I47V, G48V, I50V, I54L/M/T/V, Q58E, D60E, I62V, A71V, V77I, V82A/I, I84V, I85V L90M u I93L/M.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 October 2000
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 20 ta' Ottubru 2000
English: CYP3A4 substrates with narrow therapeutic index Agenerase must not be administered concurrently with medicinal products with narrow therapeutic windows containing active substances that are substrates of cytochrome P450 3A4 (CYP3A4).
Maltese: Is-sustanzi li jaġixxi fuqhom CYP3A4 b'therapeutic index zgħir Agenerase m'għandux jingħata flimkien ma' prodotti mediċinali b'marġinu terapewtiku dejjaq li fihom sustanzi attivi li jaġixxi fuqhom cytochrome P4503A4 (CYP3A4).
English: Co-administration of 0.035 mg ethinyl estradiol plus 1.0 mg norethindrone resulted in a decrease of the amprenavir AUC and Cmin of 22% and 20% respectively, Cmax being unchanged.
Maltese: Meta 0.035 mg ethinyl estradiol u 1.0 mg norethindrone ġew mogħtija ma' amprenavir, kien hemm nuqqas fl-AUC u Cmin ta' amprenavir ta' 22% u 20% rispettivament, filwaqt li Cmax baqà l-istess.
English: Agenerase with ritonavir must not be co-administered with medicinal products with narrow therapeutic windows that are highly dependent on CYP2D6 metabolism, e.g. flecainide and propafenone (see section 4.5).
Maltese: Agenerase ma' ritonavir m'għandux jiġi amministrat flimkien ma' prodotti mediċinali b'therapeutic windows ristretti li huma dipendenti ħafna fuq il-metaboliżmu ta' CYP2D6, eż flecainide u propafenone (ara sezzjoni 4.5).
English: NAME OF THE MEDICINAL PRODUCT Agenerase 15 mg/ml oral solution Amprenavir
Maltese: Agenerase 15 mg/ml soluzzjoni orali Amprenavir
English: In the paediatric studies APV20003 and APV29005, 67 PI-experienced patients were treated with fosamprenavir / ritonavir and of 22 virological failure isolates genotyped, nine patients were found with treatment-emergent protease mutations.
Maltese: Fl-istudji pedjatriċi APV20003 u APV29005, 67 pazjent b'esperjenza PI ingħataw fosamprenavir/ritonavir u minn 22 iżolat ta' falliment viroloġiku ġenotipat, disgħa pazjenti nstabu li kellhom mutazzjonijiet ta' protease minħabba t-trattament.
English: Rifampicin is a strong CYP3A4 inducer and has been shown to cause an 82% decrease in amprenavir AUC, which can result in virological failure and resistance development.
Maltese: Rifampicin huwa induttur qawwi ta' CYP3A4 u intwera li jikkawża tnaqqis ta' 82% fl-AUC ta' amprenavir, li jista' jirriżulta f'falliment viroloġiku u żvilupp ta' reżistenza.
English: At therapeutic dosages (1200 mg twice daily), the mean maximum steady state concentration (Cmax,ss) of amprenavir capsules is 5.36 μg/ml (0.92-9.81) and the minimum steady state concentration (Cmin,ss) is 0.28 μg/ml (0.12-0.51).
Maltese: Meta jingħataw dożi terapewtiċi (1200 mg darbtejn kuljum), il-valur intermedju tal-konċentrazzjoni fi stat stabbli massima (Cmax,ss) tal-kapsuli huwa ta' 5.36 µg/ml (0.92-9.81) filwaqt li dak talkonċentrazzjoni fi stat stabbli minima (Cmin,ss) huwa ta' 0.28 µg/ml (0.12-0.51).
English: Combination antiretroviral therapy has been associated with the redistribution of body fat (lipodystrophy) in HIV patients.
Maltese: It-terapija kombinata antiretrovirali ġiet assoċjata ma' lipodistrofija (lipodystrophy) ta' dawk ilpazjenti infettati bl-HIV.
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: Rifabutin: co-administration of amprenavir with rifabutin resulted in a 193 % increase in rifabutin AUC and an increase of rifabutin-related adverse events.
Maltese: Rifabutin: meta amprenavir ingħata flimkien ma' rifabutin kien hemm żieda ta' 193% fl-AUC ta' rifabutin u żieda f'effetti mhux mixtieqa relatati ma' rifabutin.
English: The AUC, Cmin and Cmax of amprenavir were increased by 33 %, 25 %, and 18 %, respectively.
Maltese: L-AUC, Cmin u Cmax ta' amprenavir żdiedu bi 33%, 25% u 18% rispettivament.
English: Agenerase capsules also contain sorbitol (E420).
Maltese: Il-kapsoli ta' Agenerase fihom ukoll sorbitol (E420).
English: Saquinavir: the AUC, Cmin and Cmax of saquinavir were decreased by 19 % and 48 % and increased by 21 %, respectively, when given with amprenavir.
Maltese: Saquinavir: l-AUC, Cmin u Cmax ta' saquinavir naqsu b'19% u 48% u żdiedu b'21% rispettivament meta ġie mogħti flimkien ma' amprenavir.
English: This product contains glycerol, sorbitol E420 and propylene glycol See leaflet for further information
Maltese: Dan il-prodott fih glycerol, sorbitol E420 u propylene glycol Ara l-fuljett għal aktar informazzjoni
English: Agenerase capsules contain vitamin E (109 IU/150 mg capsule), therefore additional vitamin E supplementation is not recommended.
Maltese: Il-kapsuli ta' Agenerase fihom il-vitamina E (109IU/150mg kull kapsula) u għalhekk huwa rakkomandat li m'għandiex tingħata aktar vitamina E.
English: Agenerase capsules contain vitamin E (36 IU/50 mg capsule), therefore additional vitamin E supplementation is not recommended.
Maltese: Il-kapsuli ta' Agenerase fihom il-vitamina E (36IU/50 mg kull kapsula) u għalhekk huwa rakkomandat li m'għandiex tingħata aktar vitamina E.
English: Prior number of PIs taken [n (%)]
Maltese: Numru ta' NRTI meħuda qabel [n (%)]
English: Agenerase capsules should normally be administered with low dose ritonavir as a pharmacokinetic enhancer of amprenavir (see sections 4.2 and 4.5).
Maltese: Il-kapsuli ta' Agenerase huma normalment mogħtija flimkien ma' doża baxxa ta' ritonavir, li jservi ta' pharmacokinetic enhancer għal amprenavir (ara 4.2 u 4.5).
English: This is due to induction of drug metabolising enzymes by St John's wort.
Maltese: Dan jiġri minħabba li jkun hemm stimulazzjoni ta' enzimi li jimmetabolizzaw il-mediċini permezz ta' St John's wort.
English: Oral solution
Maltese: Soluzzjoni Orali
English: The AUC, Cmin and Cmax of amprenavir were increased by 18 %, 39 %, and 15 % respectively.
Maltese: L-AUC, Cmin u Cmax ta' amprenavir żdiedu bi 18%, 39% u 15% rispettivament.
English: Coadministration of fosamprenavir 700 mg with ritonavir 100 mg twice daily and ketoconazole 200 mg once daily increased plasma ketoconazole Cmax by 25 % and increased AUC(0-τ) to values 2.69-fold those observed on administration of ketoconazole 200 mg once daily without concurrent fosamprenavir with ritonavir.
Maltese: L-għoti flimkien ta' fosamprenavir 700mg ma' ritonavir 100mg darbtejn kuljum u ketoconazole 200mg darba kuljum żied il-konċentrazzjoni ta' ketoconazole fil-plażma Cmax b'25% u żied il-valuri ta' AUC (0-τ) għal valuri ta' 2.69 ‘il darba aktar minn dawk osservati meta ittieħed ketoconazole 200mg darba kuljum mingħajr ma' ingħata flimkien ma' fosamprenavir ma' ritonavir.
English: The 50% inhibitory concentration (IC50) of amprenavir ranged from 0.012 to 0.08 µM in acutely infected cells and was 0.41 µM in chronically infected cells (1 µM = 0.50 µg/ml).
Maltese: 012 sa 0.08 µM f'ċelluli infettati b'mod akut u kienet 0.41 µM f'ċelluli infettati b'mod kroniku (1 µM=0.50µg/ml).
English: Therapeutic concentration monitoring is recommended for immunosuppressant medicinal products (cyclosporine, tacrolimus, rapamycin) when co-administered with Agenerase (see section 4.5).
Maltese: Hija rrakkomandata osservazzjoni tal-konċentrazzjoni terapewtika għall-prodotti mediċinali li jrażżnu l-immunità (cyclosporin, tacrolimus, rapamycin) meta' jingħataw flimkien ma' Agenerase (ara sezzjoni 4.5).
English: Treatment difference
Maltese: Differenza filkura
English: The other ingredients within the capsule are d-alpha tocopheryl polyethylene glycol 1000 succinate (TPGS), macrogol 400 (polyethylene glycol 400) and propylene glycol.
Maltese: Sustanzi oħra fil-kapsula jinkludu d-alpha tocopheryl polyethylene glycol 1000 succinate (TPGS), macrogol 400 (polyethylene glycol 400) u propylene glycol.
English: The use of the following medicines, together with Agenerase, should only take place on the basis of medical advice: anaesthetics (e.g. lidocaine), antibiotics (e.g. rifabutin, clarithromycin, dapsone and erythromycin), antifungals (e.g. ketoconazole, itraconazole), antimalarials (e.g. halofantrine), anticonvulsant medicines (e.g. carbamazepine, phenytoin and phenobarbital), calcium channel blockers (e.g. amlodipine, diltiazem, felodipine, isradipine, nicardipine, nifedipine, nimodipine, nisoldipine and verapamil), cholesterol lowering medicines (e.g. atorvastatin, lovastatin and simvastatin), erectile dysfunction medicines (e.g. sildenafil and vardenafil), non-nucleoside reverse transcriptase inhibitors (e.g. delavirdine, efavirenz and nevirapine), opioids (e.g. methadone), hormones like oestrogens and progestogens (e.g. hormonal contraceptives such as the ‘pill'), some glucocorticoids (e.g. fluticasone propionate and budesonide), tricyclic antidepressants (i.e. desipramine and nortriptyline), sedative agents (e.g. midazolam administered by injection), paroxetine, and others (e.g. clozapine and loratadine).
Maltese: M'għandekx tieħu l-mediċini li ġejjin flimkien ma' Agenerase sakemm mhux bl-ordni tat-tabib tiegħek: anestetiċi (i.e. lidocaine), antibijotiċi (i.e. rifabutin, clarithromycin, dapsone u erythromycin), antifungi (i.e ketoconazole, itraconazole), antimalarji (i.e. halofantrine), mediċini antikonvulsivi (i.e. carbamazepine, phenytoin, u phenobarbital), imblokkaturi tal-kanali tal-kalċju (eż amlopidine, diltiazem, felopidine, isradipine, nicarpidine, nifepidine, nimodipine, nisolpidine u verapamil) mediċini li jbaxxu l-kolesterol (i.e. atorvastatin, lovastatin u simvastatin), mediċini għal problemi fl-erezzjoni (i.e. sildenafil u vardenafil), impedituri reverse transcriptase mhux nuklejosidi (i.e. delavirdine, efavirenz u nevirapine), opjojdi (i.e. methadone), ormoni bħal estroġeni u proġestoġeni (eż kontraċettivi ormonali bħall- ‘pillola'), xi glukokortikojdi(i.e. fluticasone propionate u budesonide), antidepressanti triċikliċi (i.e desipramine u notriptyline), sustanzi sedattivi (i.e. midazolam meta jingħata fil-vina ), u oħrajn (i.e.clozapine, u loratadine).
English: Patients of 4 years and older unable to swallow Agenerase capsules: the recommended dose of Agenerase oral solution is 17 mg (1.1 ml)/kg three times a day, in combination with other antiretroviral agents, without exceeding a total daily dose of 2800 mg (see section 5.1).
Maltese: Pazjenti minn 4 snin ‘il fuq li ma jistgħux jibilgħu l-kapsuli ta' Agenerase: id-doża rakkomandata ta' soluzzjoni orali ta' Agenerase hija ta' 17 mg (1.1 ml) kull kilogramm tliet darbiet kuljum, flimkien ma' mediċini antiretrovirali oħra, mingħajr ma tinqabeż id-doża totali ta' 2800 mg kuljum (ara sezzjoni 5.1).