FrancophonIA/ELRC3.0 huggingface dataset:
English: HIV-1 isolates with decreased susceptibility to amprenavir have been selected during in vitro serial passage experiments Reduced susceptibility to amprenavir was associated with virus that had developed I50V or I84V or V32I+I47V or I54M mutations.
Maltese: Suxxettibilità mnaqqsa għal amprenavir kienet assoċċjata ma' virus li kien żviluppa mutazzjonijiet I50V jew I84V jew V321+I47V jew I54M.
English: Oblong, opaque, off-white to cream coloured, printed with ‘GX CC2'.
Maltese: Forma rettangolari, opaki b'lewn abjad maħmuġ jkanġi għall-krema u stampati bl-ittri ‘GX CC2'.
English: Most of the adverse events below come from two clinical trials (PROAB3001, PROAB3006) involving PI naïve subjects receiving Agenerase 1200mg twice daily.
Maltese: Ħafna mill-informazzjoni dwar l-effetti mhux mixtieqa li jissemmew hawn taħt inġabret waqt żewġ studji kliniċi (PROAB3001, PROAB3006) li fihom ħadu sehem pazjenti li qatt ma kienu ngħataw kura permezz tal-inibituri protease u li kienu qegħdin jirċievu 1200 mg Agenerase darbtejn kuljum.
English: Ketoconazole / Itraconazole: the AUC and Cmax of ketoconazole were increased by 44 % and 19 % respectively when given with amprenavir alone.
Maltese: Ketoconazole / Itraconazole: l-AUC u Cmax ta' ketoconazole żdiedu b'44% u 19% rispettivament meta ġie mogħti flimkien ma' amprenavir waħdu.
English: One hundred and sixty-three (163) patients with virus sensitive to Agenerase, at least one other PI, and at least one NRTI were included in PRO30017 substudy A. The primary analysis assessed the noninferiority of APV/r to the SOC PI group with respect to time-weighted average change from baseline (AAUCMB) in plasma viral load (HIV-1 RNA) at week 16 using a non-inferiority margin of 0.4 log10 copies/ml.
Maltese: Mija u tlieta u sittin (163) pazjent b'virus sensittiv għal Agenerase, almenu PI ieħor, u almenu NRTI ieħor kienu inklużi fl-istudju sekondarju ta' PRO30017.
English: Based on data from twenty-five antiretroviral naïve patients failing a fosamprenavir containing regimen (one of whom showed Baseline resistance to lopinavir and saquinavir and another to tipranavir) the resistance pathways associated with amprenavir produce limited cross-resistance to atazanavir/ritonavir (three of 25 isolates), darunavir/ritonavir (four of 25 isolates), indinavir/ritonavir (one of 25 isolates), lopinavir/ritonavir (three of 24 isolates), saquinavir (three of 24 isolates) and tipranavir/ritonavir (four of 24 isolates).. Conversely amprenavir retains activity against some isolates with resistance to other PIs and this retained activity would depend on the number and type of protease resistance mutations present in the isolates.
Maltese: Fuq bażi ta' data minn ħamsa u għoxrin pazjent mingħajr esperjenza antiretrovirali li fallew fuq sistema ta' kura b'fosamprenavir (fejn wieħed minnhom wera reżistenza tal-Lina Bażi għal lopinavir u saquinavir u ieħor għal tipranavir), il-passaġġi ta' reżistenza assoċċjati ma' amprenavir jipproduċu cross-resistance limitata għal atazanavir/ritonavir (tlieta minn 25 iżolat), darunavir/ritonavir (erba' minn 25 iżolat), indinavir/ritonavir (wieħed minn 25 iżolat), lopinavir/ritonavir (tlieta minn 24 iżolat), saquinavir (tlieta minn 24 iżolat) u tipranavir/ritonavir (erba' minn 24 iżolat).
English: This medicinal product contains 4 mg sodium per ml.
Maltese: Dan il-prodott mediċinali fih 4mg ta' sodium kull ml.
English: Ritonavir: the AUC and Cmin of amprenavir were increased by 64% and 508% respectively and the Cmax decreased by 30% when ritonavir (100 mg twice daily) was coadministered with amprenavir capsules (600 mg twice daily) compared to values achieved after 1200 mg twice daily doses of amprenavir capsules.
Maltese: Ritonavir: l-AUC u Cmin ta' amprenavir żdiedu b'64% u 508% rispettivament filwaqt li s-Cmax naqas bi 30% meta ritonavir (100 mg darbtejn kuljum) ġie mogħti flimkien ma' kapsuli ta' amprenavir (600 mg darbtejn kuljum) meta mqabbla ma' valuri milħuqa wara li ġiet mogħtija doża ta' 1200 mg ta' kapsuli ta' amprenavir darbtejn kuljum.
English: Adults and adolescents of 12 years of age and older (greater than 50 kg body weight): the recommended dose of Agenerase capsules is 600 mg twice daily with ritonavir, 100 mg twice daily, in combination with other antiretroviral agents.
Maltese: Adulti u adoloxxenti minn 12-il sena ‘l fuq (piż tal-ġisem aktar minn 50kg): id-doża normali ta' kapsuli ta' Agenerase hija ta' 600 mg darbtejn kuljum flimkien ma' 100 mg ritonavir darbtejn kuljum, flimkien ma' mediċini antiretrovirali oħra.
English: • Moodiness, depression, difficulty sleeping, loss of appetite
Maltese: • Taqlib fil-burdata, dipressjoni, diffikulta fl-irqad, nuqqas ta' aptit
English: - if you are currently taking any products containing St John's wort (Hypericum perforatum) as this may stop Agenerase from working properly (see Taking/using other medicines).
Maltese: -jekk qed tieħu mediċini li fihom St John's Wort (Hypericum perforatum) għax dawn jistgħu itellfu lil Agenerase milli jaħdem kif suppost (ara ‘Qabel ma tieħu/tuża mediċini oħra).
English: The combination of rifampicin and Agenerase with concomitant low-dose ritonavir is contraindicated (see section 4.3).
Maltese: Il-kumbinazzjoni ta' rifampicin u Agenerase flimkien ma' doża baxxa ta' ritonavir hija kontraindikata (ara sezzjoni 4.3)
English: Ketoconazole / Itraconazole: the AUC and Cmax of ketoconazole were increased by 44 % and 19 % respectively when given with amprenavir.
Maltese: Ketoconazole / Itraconazole: l-AUC u Cmax ta' ketoconazole żdiedu b'44% u 19% rispettivament meta ġie mogħti flimkien ma' amprenavir.
English: Erectile dysfunction agents: based on data for other protease inhibitors caution should be used when prescribing PDE5 inhibitors (e.g. sildenafil and vardenafil) to patients receiving Agenerase.
Maltese: Erectile Dysfunction Agents: fuq tagħrif miġbur dwar inibituri protease oħra, huwa għaqli li wieħed jippreskrivi b'attenzjoni inibituri ta' PDE5 (eż sildenafil u vardenafil) f'pazjenti li qed jirċievu Agenerase.
English: Tel: + 43 (0)1 97075 0 at.info@gsk.com
Maltese: Tel: + 370 5 264 90 00 info.lt@gsk.com
English: Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
Maltese: L-użu fl-istess ħin ta' aktar minn mediċina waħda antiretrovirali ġie assoċjat ma' anormalitàjiet filmetaboliżmu bħal ma huma livelli għoljin ta' trigliċeridi u kolesterol, reżistenza għall-insulina, ipergliċemija u iperlaktemja (ara 4.4).
English: Headache
Maltese: ISEM
English: Concentrations of AAG have been shown to decrease during the course of antiretroviral therapy.
Maltese: Agenerase huwa preskritt sabiex jintuża flimkien ma' mediċini antiretrovirali oħra.
English: Systemic corticosteroid effects including Cushing's syndrome and adrenal suppression have been reported in patients receiving ritonavir and inhaled or intranasally administered fluticasone propionate; this could also occur with other corticosteroids metabolised via the P450 3A pathway e.g. budesonide.
Maltese: Effetti sistemiċi tal-kortikosterojdi bħas-sindromu ta' Cushing u trażżin tal-glandola adrenali ġew irrapurtati f'pazjenti li kienu fuq ritonavir u fluticasone propionate li inġibed ġol-pulmun jew ittieħed millimnieħer; dan jista' jiġri wkoll b'kortikosterojdi oħra li jiġu mmetaboliżżati mir-rotta P450 3A eż. budesonide.
English: The usual dose for Agenerase capsules is 20 mg for each kg of body weight, twice a day.
Maltese: Id-doża normali ta' kapsuli ta' Agenerase hija ta' 20 mg għal kull kilogramm ta' piż tal-gisem darbtejn kuljum.
English: Elevated triglycerides, elevated amylase and hyperglycaemia (grade 3-4) were reported primarily in patients with abnormal values at baseline.
Maltese: Il-livelli għolja ta' trigliċeridi u amylase u l-ipergliċemija (grade 3-4) kienu l-aktar komuni f'pazjenti li kellhom livelli mhux normali fil-linja bażika.
English: Dosages of 20 mg/kg twice a day and 15 mg/kg three times a day with Agenerase capsules provided similar daily amprenavir exposure to 1200 mg twice a day in adults.
Maltese: Dożi ta' 20 milligramma/kg darbtejn kuljum u ta' 15 milligramma/kg tliet darbiet kuljum ta' kapsuli ta' Agenerase kienu jixbħu ħafna d-doża ta' 1200 mg darbtejn kuljum fil-kbar għaliex jipprovdu bejn wieħed u ieħor l-istess livell ta' amprenavir.
English: This must be taken into consideration when prescribing to patients on a controlled sodium diet.
Maltese: Dan għandu jiġi kkunsidrat meta jingħata lil pazjenti fuq dieta kkontrollata ta' sodium.
English: The 50 mg and 150 mg capsules have been shown to be bioequivalent.
Maltese: Instab li l-kapsuli tal-50 mg u dawk tal-150 mg huma bijoekwivalenti.
English: Various regimens have been assessed in the amprenavir/fosamprenavir development programs with and without co-administration of ritonavir.
Maltese: Ġew assessjati diversi sistemi ta' kura differenti fil-programmi ta' żvilupp amprenavir/fosamprenavir kemm meta jingħata ma' ritonavir u kemm meta le.
English: General disorders and administration site conditions Very Common:
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni ħafna:
English: Osteonecrosis
Maltese: FARMAĊEWTIKU
English: Agenerase should be permanently discontinued when rash is accompanied with systemic symptoms or allergic symptoms or mucosal involvement (see section 4.8).
Maltese: Agenerase għandu jiġi mwaqqaf għal dejjem jekk ir-raxx ikun akkompanjat minn sintomi fil-ġisem kollu, sintomi allerġiċi jew involviment tal-mukoża (ara 4.8).
English: The inducing effect may persist for at least 2 weeks after cessation of treatment with St John's wort.
Maltese: L-effett stimulanti jistà jdum għal ta' l-inqas ġimagħtejn wara li St John's wort ikun twaqqaf.
English: PACKAGE LEAFLET : INFORMATION FOR THE USER Agenerase 150 mg soft capsules Amprenavir
Maltese: INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Agenerase 150 mg, kapsuli rotob Amprenavir
English: Severe or life-threatening skin reactions have also occurred in patients treated with amprenavir (see section 4.4).
Maltese: Meta ritonavir jingħata miegħu jista' jkun hemm bżonn aktar tnaqqis fid-doża (ara sezzjoni 4.5).
English: The active substance is amprenavir The Agenerase oral solution contains 15 mg/ml of amprenavir.
Maltese: Is-sustanza attiva hi amprenavir Is-soluzzjoni orali fiha 15 mg/ml ta' amprenavir
English: The mutational profiles were similar to those described for PI-experienced adults treated with fosamprenavir / ritonavir.
Maltese: Il-profili ta' mutazzjonijiet kienu simili għal dawk deskritti għal adulti b'esperjenza PI trattati b'fosamprenavir / ritonavir.
English: Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk of severe and potentially fatal hepatic adverse events.
Maltese: Bħalissa, l-ebda terapija antiretrovirali ma ġiet ippruvata li tnaqqas ir-riskju tat-tixrid tal-HIV permezz ta' kuntatti sesswali jew permezz tad-demm.
English: The use of Agenerase concomitantly with halofantrine or lidocaine (systemic) is not recommended (see section 4.5).
Maltese: Mhuwiex rakkomandat l-użu ta' Agenerase flimkien ma' halofantrine jew lidocaine (sistemiku) (ara sezzjoni 4.5).
English: Amprenavir is 14 % less bioavailable from the Agenerase oral solution than from the capsules; therefore, Agenerase capsules and Agenerase oral solution are not interchangeable on a milligram per milligram basis (see section 5.2).
Maltese: Għalhekk, il-kapsuli rotob ta' Agenerase u s-soluzzjoni orali ta' Agenerase ma jistgħux jiġu mibdula ma' xulxin fuq bażi ta' milligramma għal milligramma (ara 5.2).
English: The primary route of metabolism is via the cytochrome P450 CYP3A4 enzyme.
Maltese: Il-mod prinċipali ta' kif iseħħ dan il-metaboliżmu huwa permezz ta' l-enzima CYP3A4 taċ-ċitokromju P450.
English: - bepridil (used to treat hypertension).
Maltese: - bepridil (li jintuża biex jikkura l-pressjoni għolja).
English: MARKETING AUTHORISATION NUMBER EU/1/00/148/004
Maltese: FIS-SUQ EU/1/00/148/004
English: Lipodystrophy
Maltese: Lamivudine:
English: Distribution: the apparent volume of distribution is approximately 430 litres (6 l/kg assuming a 70 kg body weight), suggesting a large volume of distribution, with penetration of amprenavir freely into tissues beyond the systemic circulation.
Maltese: Distribuzzjoni: il-volum ta' distribuzzjoni hekk kif jidher, huwa ta' madwar 430 litru (6 l/kg jekk tieħu piż tal-ġisem ta' 70kg).
English: Propylene glycol can cause a range of adverse effects including seizures, stupor, rapid heart beat and the breakdown of red blood cells (see also Do not take Agenerase, Take special care with Agenerase).
Maltese: Propylene glycol jista' jwassal għal sensiela ta' effetti avversi bħal aċċessjonijiet, stupor, qalb tħabbat ħafna u ħsara fic-celloli ħomor tad-demm (ara wkoll Tieħux Agenerase u Oqgħod attent ħafna b'Agenerase).
English: Amprenavir is 14 % less bioavailable from the oral solution than from the capsules; therefore, Agenerase capsules and Agenerase oral solution are not interchangeable on a milligram per milligram basis.
Maltese: Għalhekk, il-kapsuli ta' Agenerase u s-soluzzjoni orali ta' Agenerase ma jistgħux jiġu mibdula ma' xulxin fuq bażi ta' milligramma għal milligramma.
English: Therefore medicinal products that are inducers, inhibitors or substrates of CYP3A4 must be used with caution when administered concurrently with Agenerase (see sections 4.3, 4.4 and 4.5).
Maltese: Għalhekk mediċini li huma stimulanti, inibituri jew substrati ta' CYP3A4 għandhom jintużaw b'attenzjoni kbira meta jingħataw flimkien ma' Agenerase (ara 4.3, 4.4, 4.5).
English: Other possible effects
Maltese: EFFETTI
English: Amprenavir is primarily bound to the alpha-1-acid glycoprotein (AAG), but also to albumin.
Maltese: Amprenavir huwa l-biċċa l-kbira mwaħħal ma' alpha-1-acid glycoprotein (AAG), iżda xi ftit minnu jeħel ukoll ma' l-albumina.
English: Agenerase capsules should normally be given in combination with low dose ritonavir and in combination with other antiretroviral agents (see section 4.2).
Maltese: Il-kapsuli ta' Agenerase huma normalment mogħtija flimkien ma' doża baxxa ta' ritonavir, flimkien ma' mediċini antiretrovirali oħra (ara 4.2).
English: Oral/perioral paraesthesia, tremors, sleep disorders Gastrointestinal disorders Very Common:
Maltese: Anti-koagulanti orali: monitoraġġ rinfurzat tal-Proporzjon Internazzjonali
English: This product contains propylene glycol, potassium and sodium See leaflet for further information
Maltese: Dan il-prodott fih propylene glycol, potassium u sodium Ara l-fuljett għal aktar informazzjoni
English: algorithm for fosamprenavir / ritonavir defines resistance as the presence of the mutations V32I+I47A/V, or I50V, or at least four mutations among: L10F/I/V, L33F, M36I, I54A/L/M/S/T/V, I62V, V82A/C/F/G, I84V and L90M and is associated with increased phenotypic resistance to fosamprenavir with ritonavir as well as reduced likelihood of virological response (resistance).
Maltese: L10F/I/V, L33F, M36I, I54A/L/M/S/T/V, I62V, V82A/C/F/G, I84V u L90M u hija assoċċjata ma' żieda fir-reżistenza fenotipika għal fosamprenavir ma' ritonavir kif ukoll bħala ċans anqas ta' rispons viroloġiku (reżistenza).
English: Österreich GlaxoSmithKline Pharma GmbH
Maltese: GlaxoSmithKline Lietuva UAB
English: Glaxo Wellcome House Berkeley Avenue Greenford
Maltese: Glaxo Wellcome Operations Speke Boulevard Speke
English: Hepatic impairment: Agenerase oral solution is contraindicated in patients with hepatic impairment or failure (see section 4.3) (see Summary of Product Characteristics of Agenerase Capsules for prescribing information)
Maltese: Indeboliment tal-fwied: is-soluzzjoni orali ta' Agenerase hija kontra-indikata f'pazjenti li jbatu minn ħsara jew insuffiċjenza tal-fwied (ara 4.3) (ara l-Karatteristiċi tal-Prodott fil-Qosor tal-kapsuli ta' Agenerase għal informazzjoni fuq kif għandek tippreskrivi)
English: Co-administration may result in competitive inhibition of the metabolism of these active substances thus increasing their plasma level and leading to serious and / or life-threatening adverse reactions such as cardiac arrhythmia (e.g. amiodarone, astemizole, bepridil, cisapride, pimozide, quinidine, terfenadine) or peripheral vasospasm or ischaemia (e.g. ergotamine, dihydroergotamine).
Maltese: Meta jingħataw flimkien dan jista' jwassal għal inibizzjoni kompetitiva tal-metaboliżmu ta' dawn is-sustanzi attivi u b'hekk iżid il-livell tagħhom fil-plażma u jwassal għal reazzjonijiet avversi serji u / jew ta' periklu għas-saħħa bħal arritmija tal-qalb (eż amiodarone, astemizole, bepridil, cisapride, pimozide, quinidine, terfenadine) jew spażmu ta' l-arterji periferali jew iskemija (eż ergotamine, dihydroergotamine).
English: Agenerase oral solution is also contraindicated in patients treated with disulfiram or other medicinal products that reduce alcohol metabolism (e.g. metronidazole) and preparations that contain alcohol (e.g. ritonavir oral solution) or additional propylene glycol (see section 4.4and 5.1).
Maltese: Is-soluzzjoni orali ta' Agenerase hija kontra-indikata wkoll f'dawk il-pazjenti li qed jieħdu kura permezz ta' disulfiram jew mediċini oħra li jnaqqsu il-metaboliżmu ta' l-alkoħol (eż. metronidazole) u preparazzjonijiet oħra li fihom l-alkoħol (eż. soluzzjoni orali ta' ritonavir) jew aktar propylene glycol (ara 4.4 u 5.1).
English: When ART naïve patients were treated with the currently approved doses of fosamprenavir/ritonavir, as for other ritonavir boosted PI regimens, the mutations described were rarely observed.
Maltese: Meta pazjenti mingħajr esperjenza ta' ART ingħataw kura b'dożi approvati bħalissa ta' fosamprenavir/ritonavir, bħal sistemi oħra ta' kura PI imsaħħin b'ritonavir, il-mutazzjonijiet deskritti kienu osservati rarament.
English: In long-term carcinogenicity studies with amprenavir in mice and rats, there were benign hepatocellular adenomas in males at exposure levels equivalent to 2.0-fold (mice) or 3.8-fold (rats) those in humans given 1200 mg twice daily of amprenavir alone.
Maltese: Dan seħħ meta kien hemm livelli ta' mediċina li kienu għal darbtejn aktar (fil-ġrieden) u għal 3.8 darbiet aktar (fil-firien) minn dawk li jintlaħqu fil-bnedmin meta jiġu mogħtija 1200 mg darbtejn kuljum ta' amprenavir waħdu.
English: (Note: Agenerase is not approved in ART-naive or PI-naive patients).
Maltese: (ara ‘Oqgħod attent ħafna b'Agenerase).
English: MARKETING AUTHORISATION NUMBER EU/1/00/148/003
Maltese: FIS-SUQ EU/1/00/148/003
English: The metabolism of pravastatin and fluvastatin is not dependent on CYP3A4, and interactions are not expected with protease inhibitors.
Maltese: Il-metaboliżmu ta' pravastatin u fluvastatin ma jiddependix fuq CYP3A4 u għalhekk wieħed ma jistenniex li jkun hemm problemi meta jintużaw ma' inibituri protease.
English: Agenerase oral solution also contains 4 mg sodium per ml.
Maltese: Is-soluzzjoni orali ta' Agenerase fiha wkoll 4mg ta' sodium kull ml.
English: PACKAGE LEAFLET : INFORMATION FOR THE USER Agenerase 15 mg/ml oral solution Amprenavir
Maltese: INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Agenerase 15 mg/ml, soluzzjoni orali Amprenavir
English: Co-administration may result in competitive inhibition of the metabolism of these medicinal products and create the potential for serious and/or life-threatening adverse events such as cardiac arrhythmia (e.g. amiodarone, bepridil, quinidine, terfenadine, astemizole, cisapride, pimozide), respiratory depression and /or prolonged sedation (e.g. oral triazolam and oral midazolam (for caution on parenterally administred midazolam, see section 4.5)) or peripheral vasospasm or ischaemia and ischaemia of other tissues, including cerebral or myocardial ischaemia (e.g. ergot derivatives).
Maltese: It-teħid flimkien jista' jirriżulta f'inibizzjoni kompetitiva tal-metaboliżmu ta' dawn il-mediċini, li jista' jwassal għal possibbiltà ta' reazzjonijiet avversi li huma serji jew li jpoġġu l-ħajja tal-pazjent f'periklu, bħal arritmija kardijaka (eż. amiodarone, beprdil, quinidine, terfenadine, astemizole, cisapride, pimozide), dipressjoni respiratorja u/jew sedazzjoni fit-tul (eż triazolam mill-ħalq u midazolam mill-ħalq (ara sezzjoni 4.5 għal kawtela ta' kif tuża midazolam fil-vina) jew vasospażmu periferali jew iskemija u iskemija ta' tessuti oħra talġisem, inkluż iskemija ċerebrali jew mijokardjali (eż. derivati ta' ergot).
English: Data from concomitant use of parenteral midazolam with other protease inhibitors suggest a possible 3-4 fold increase in midazolam plasma levels.
Maltese: Informazzjoni mill-użu flimkien ta' midazolam mill-vina u inibituri oħra ta' protease juru possibilita' ta' żieda ta' 3-4 darbiet aktar fil-livelli ta' midazolam fil-plażma.
English: Events (grade 2-4) reported by study investigators as attributable to study medication and occurring in >1% of patients, are included as well as grade 3-4 treatment emergent laboratory abnormalities.
Maltese: Din linformazzjoni tinkludi dawk l-effetti (grad 2-4), li skond l-investigaturi ta' dawn l-istudji, huma ta' min jattribwihom għall-mediċina li kienet qed tiġi studjata u li ħarġu f'aktar minn 1% tal-pazjenti.
English: • Diarrhoea, feeling sick, vomiting, flatulence
Maltese: • Diarreja, tħossok imqalla, rimettar, gass
English: In vivo
Maltese: FEJN MA
English: Based on pharmacokinetic data, the dose of Agenerase capsules should be reduced to 450 mg twice a day for adult patients with moderate hepatic impairment and to 300 mg twice a day for adult patients with severe hepatic impairment.
Maltese: Dan it-tagħrif jirrikmanda li d-doża tal-kapsuli ta' Agenerase għandha titnaqqas għal 450 mg darbtejn kuljum f'pazjenti adulti li jbatu minn indeboliment moderat fil-fwied.
English: Caution is advised when Agenerase is used concomitantly with delavirdine (see section 4.5).
Maltese: Hi rrakkomandata l-kawtela meta Agenerase jintuża flimkien ma' delavirdine (ara sezzjoni 4.5).
English: If a patient is already taking St John's wort, check amprenavir and if possible viral levels and stop St John's wort.
Maltese: Jekk xi pazjent ikun qiegħed jieħu St.John's wort, wieħed irid jiċċekja l-livell ta' amprenavir kif ukoll il-livell talvajrus, filwaqt li St.John's wort jitwaqqaf.
English: CYP2D6 substrates with narrow therapeutic index Agenerase with ritonavir must not be co-administered with medicinal products containing active substances that are highly dependent on CYP2D6 metabolism and for which elevated plasma concentrations are associated with serious and / or life-threatening adverse reactions.
Maltese: Is-sustanzi li jaġixxi fuqhom CYP2D6 b'therapeutic index zgħir Agenerase ma' ritonavir m'għandux jingħata flimkien ma' prodotti mediċinali li fihom sustanzi attivi li jiddependu ħafna fuq il-metaboliżmu ta' CYP2D6 u fejn żieda fil-konċentrazzjoni tal-plażma huma assoċjati ma' reazzjonijiet avversi serji jew/u ta' periklu għas-saħħa.
English: The current (July 2006) ANRS AC-11 algorithm for fosamprenavir / ritonavir defines resistance as the presence of the mutations V32I+I47A/V, or I50V, or at least four mutations among: L10F/I/V, L33F, M36I, I54A/L/M/S/T/V, I62V, V82A/C/F/G, I84V and L90M and is associated with increased phenotypic resistance to fosamprenavir with ritonavir as well as reduced likelihood of virological response (resistance).
Maltese: L-algoritmu kurrenti (Lulju 2006) ANRS AC-11 għal fosamprenavir/ritonavir jiddefinixxi reżistenza bħala lpreżenza tal-mutazzjonijiet V32I+I47A/V, jew I50V, jew almenu erba' mutazzjonijiet minn:
English: The AUC and Cmin of amprenavir were increased by 64% and 508% respectively and the Cmax decreased by 30% when ritonavir (100 mg twice daily) was coadministered with amprenavir (600 mg twice daily) compared to values achieved after 1200 mg twice daily doses of amprenavir.
Maltese: Kien hemm żieda fl-AUC u Cmin ta' amprenavir ta' madwar 64% u 508% rispettivament, filwaqt li Cmax naqas b'madwar 30% meta ritonavir (100 mg darbtejn kuljum) kien mogħti ma' amprenavir (600 mg darbtejn kuljum).