FrancophonIA/ELRC3.0 huggingface dataset:
English: Telzir 700 mg film-coated tablets Fosamprenavir
Maltese: Telzir 700 mg Pilloli miksija b'rita Fosamprenavir
English: Frequencies are defined as: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000) or Very rare (< 1/10,000), or Not known.
Maltese: Il-frekwenzi huma definiti bħala Komuni ħafna (≥1/10), Komuni (≥1/100 sa <1/10), Mhux komuni (≥1/1,000 sa <1/100), Rari (≥1/10,000 sa <1/1,000), jew Rari ħafna (≤1/10,000), jew Mhux magħruf.
English: Contraindicated (see section
Maltese: Kontraindikat (ara sezzjoni
English: In females, at the high dose, there was a reduction in the weight of gravid uterus (0 to 16%) probably due to a reduction of the number of ovarian corporea lutea and implantations.
Maltese: Fin-nisa, bid-doża għolja, kien hemm tnaqqis fil-piż tal-utru waqt it-tqala (0 sa 16 %) probabbilment minħabba tnaqqis fin-numru ta' corpora lutea u impjanti ovarji.
English: itraconazole are not recommended.
Maltese: ta' ketoconazole jew itraconazole.
English: Pharmacotherapeutic group: Antivirals for systemic use, protease inhibitor, ATC Code: J05AE07 Mechanism of action
Maltese: Antivirali għal użu sistemiku, impeditur protease, Kodiċi ATC:
English: Drug-related adverse reactions were more common in APV20003 (57%) where subjects received once daily fosamprenavir / ritonavir when compared to APV29005 (33%) where subjects received twice daily fosamprenavir / ritonavir.
Maltese: Reazzjonijiet avversi marbuta mal-mediċina kienu aktar komuni f'APV20003 (57%) fejn l-individwi rċivew fosamprenavir/ritonavir darba kuljum meta mqabbla ma' APV29005 (33%) fejn l-individwi rċivew fosamprenavir/ritonavir darbtejn kuljum.
English: The pharmacokinetics of fosamprenavir have not been studied in this patient population (see section 5.2).
Maltese: Il-farmakokinetiċi ta' fosamprenavir ma ġewx studjati f'dan il-grupp ta' pazjenti (ara sezzjoni 5.2).
English: Co-administration of fosamprenavir/ritonavir with other antineoplastics metabolised by CYP3A (for example dasatinib, nilotinib, ibrutinib, vinblastine and everolimus) may increase concentrations of these medicinal products, potentially increasing the risk of adverse events usually associated with these agents.
Maltese: L-għoti ta' fosamprenavir/ritonavir ma' antineoplastiċi oħrajn metabolizzati minn CYP3A (pereżempju dasatinib, nilotinib, ibrutinib, vinblastine u everolimus) jista' jżid il-konċentrazzjonijiet ta' dawn il-prodotti mediċinali, u potenzjalment iżid ir-riskju ta' avvenimenti avversi li normalment huma assoċjati ma' dawn is-sustanzi.
English: Co-administration of TELZIR/ritonavir with alfuzosin is contraindicated (see section 4.3).
Maltese: TELZIR/ritonavir flimkien ma' alfuzosin huwa kontraindikat (ara sezzjoni 4.3).
English: Fluticasone propionate 50 µg intranasal 4 times daily) for 7 days
Maltese: 50 µg ġo l-imnieħer 4 darbiet kuljum) għal 7 ijiem
English: Industriestrasse 32-36 D-23843 Bad Oldesloe Germany or
Maltese: Aspen Bad Oldesloe GmbH Industriestrasse 32 - 36 D-23843 Bad Oldesloe Il-Ġermanja jew
English: Administration of the fosamprenavir oral suspension formulation with a high fat meal (967 kcal, 67 grams fat, 33 grams protein, 58 grams carbohydrate) reduced plasma amprenavir AUC(0-∞) by 28% and Cmax by 46% and delayed Tmax by 0.72 hours.
Maltese: gramma ta' xaħam, 33 gramma proteina, 58 gramma karboidrati) naqqas l-AUC (0-∞) ta' amprenavir fil-plażma b'madwar 28% u s-Cmax b' 46% u ttardja Tmax b'0.72 siegħa.
English: See section ‘Other medicines and Telzir'.
Maltese: Ara s-sezzjoni ‘Mediċini oħra u Telzir'.
English: The recommended dose is 0.36 ml/kg of Telzir oral suspension (18 mg per kg fosamprenavir) twice daily with 3 mg/kg ritonavir oral solution twice daily.
Maltese: Id-doża rakkomandata tas-suspensjoni orali ta' Telzir hija ta' 0.36ml/ kg piż tal-ġisem (18mg/kg fosamprenavir) darbtejn kuljum bi 3mg għal kull kg ta' piż tal-ġisem għas-soluzzjoni orali ta' ritonavir darbtejn kuljum.
English: 60 film-coated tablets
Maltese: 60 pillola.
English: Sixteen of 434 ART-naïve patients who received fosamprenavir 700 mg/ritonavir 100 mg twice daily in ESS100732 experienced virological failure by Week 48 with 14 isolates genotyped.
Maltese: 700 mg/ritonavir 100 mg darbtejn kuljum f'ESS100732 esperjenzaw falliment viroloġiku sa Ġimgħa 48 b'14-iliżolat ġenotipat.
English: The potential for cross-sensitivity between medicinal products in the sulphonamide class and fosamprenavir is unknown.
Maltese: Il-potenzjal ta' cross-sensitivity bejn prodotti mediċinali tal-klassi tas-sulphonamides u fosamprenavir mhux magħruf.
English: The primary route of metabolism is via the cytochrome P450 3A4 enzyme.
Maltese: Ir-rotta ewlenija tal-metaboliżmu hi permezz ta' l-enzima ċitokromju P450 3A4.
English: There have been reports of muscle pain, tenderness or weakness, particularly with antiretroviral therapy including protease inhibitors and nucleoside analogues.
Maltese: Kien hemm rapporti ta' uġigħ fil-muskoli, sensibilita' jew nuqqas ta' saħħa, speċjalment b'terapija antiretrovirali li tinkludi inibituri tal-protease u analogi tan-nukleosidi.
English: Additional mutations observed which may contribute to resistance were: L10V/F/R, I13V, K20R/T, L33F/V, M36I, M46I/L, I47V/L Q58E, I62V, L63P, V77I, I85V, and I93L.
Maltese: II3V, K20R/T, L33F/V, M361, M461/L, 147V/L Q58E, 162V, L63P, V771, 185V, u 193L.
English: Telzir belongs to a group of anti-retroviral medicines called protease inhibitors.
Maltese: Telzir jagħmel parti minn grupp ta' mediċini anti-retrovirali li jissejħu inibituri tal-protease.
English: Telzir tablet and oral suspension formulations, both given fasted, delivered equivalent plasma amprenavir AUC∞ values and the Telzir oral suspension formulation delivered a 14 % higher plasma amprenavir Cmax as compared to the oral tablet formulation.
Maltese: Il-formulazzjonijiet ta' pilloli u suspensjoni orali Telzir, it-tnejn kemm huma meħudin waqt sawma, ipproduċew valuri ekwivalenti ta' AUC∞ ta' amprenavir fil-plażma u l-formulazzjoni ta' suspensjoni orali ta' Telzir ipproduċiet 14% aktar ta' Cmax ta' amprenavir fil-plażma meta mqabbla malformulazzjoni ta' pillola mill-ħalq.
English: Lopinavir: Cmax ↔* Lopinavir: AUC ↔* Lopinavir: Cmin ↔* * compared to lopinavir / ritonavir 400 mg/100 mg twice daily
Maltese: AUC ↔* Lopinavir: Cmin ↔* * meta mqabbla ma' lopinavir / ritonavir 400 mg/100 mgdartbejn kuljum
English: Table 3 Efficacy at Week 48 Outcomes in APV30003 ITT(E) Population (ART-experienced Patients)
Maltese: Tabella 3 Effikaċja fil-Ġimgħa 48 mir-Riżultati fil-Popolazzjoni APV30003 ITT(E) (Pazjenti li kellhom esperjenza ta' kura b'ART)
English: Co-administration of paritaprevir and fosamprenavir/ritonavir (FPV/RTV) is contraindicated due to the expected increase of paritaprevir exposure and the lack of clinical data assessing the magnitude of this increase (see section 4.5).
Maltese: L-għoti ta' paritaprevir flimkien ma' fosamprenavir/ritonavir (FPV/RTV) huwa kontroindikat minħabba żidiet mistennija tal-esponiment ta' paritaprevir u n-nuqqas ta' dejta klinika li tivvaluta d daqs ta' din iż-żieda (ara sezzjoni 4.5).
English: 20 mg once daily
Maltese: 20 mg darba kuljum
English: Norethisterone: Cmax
Maltese: Norethisterone:
English: Immune Reactivation Syndrome
Maltese: Sindromu tar-Reattivazzjoni Immunitarja
English: Ritonavir also inhibits CYP2D6 but to a lesser extent than CYP3A4.
Maltese: Ritonavir jinibixxi wkoll CYP2D6 imma mhux daqs CYP3A4.
English: There have been reports of increased bleeding including spontaneous skin haematomas and haemarthroses in haemophiliac patients type A and B treated with protease inhibitors (PIs).
Maltese: Kien hemm xi rapporti ta' żieda fil-fsada inklużi ematomi spontanji u emartrożi fil-ġilda ta' pazjenti bl-emofilja tat-tipi A u B fuq kura ta' impedituri protease (PIs).
English: AUC ↓ 55% (-76%; -16%) Cmin ↓ 36 % (-57%; -3%)
Maltese: Cmax ↓ 51% (-75%; -3%) AUC ↓ 55% (-76%; -16%) Cmin ↓ 36 % (-57%; -3%)
English: Ritonavir AUC12 ↓ 0.66 Ritonavir Cmax ↓ 0.61 Ritonavir C12 ↔ 0.86
Maltese: Ritonavir AUC12 ↓ 0.66
English: In repeated dose toxicity studies in adult rats and dogs, fosamprenavir produced evidence of gastrointestinal disturbances (salivation, vomiting and soft to liquid faeces), and hepatic changes (increased liver weights, raised serum liver enzyme activities and microscopic changes, including hepatocyte necrosis).
Maltese: Fi studji ripetuti tat-tossiċità tad-doża f'firien u klieb adulti, fosamprenavir wera evidenza ta' disturbi gastro-intestinali (żieda fil-bżieq, rimettar u purgar artab jew maħlul), u tibdil fil-fwied, (żieda fil-piż tal-fwied, attivitajiet aktar ta' enżimi tal-fwied fis-serum u tibdiliet mikroskopiċi, inkluża nekrosi ta' lepatoċiti).
English: Compared to the historical adult population receiving fosamprenavir with ritonavir 700 mg / 100 mg twice daily, a subset of five pediatric subjects ages 6 to < 24-months receiving fosamprenavir / ritonavir 45/7 mg/kg twice daily demonstrated that despite an approximate 5-fold increase in fosamprenavir and ritonavir doses on a mg/kg basis, plasma amprenavir AUC(0-τ) was approximately 48 % lower, Cmax 26 % lower, and Cτ 29 % lower in the paediatric subjects.
Maltese: Meta mqabbla ma' popolazzjoni adulta li fil-passat ħadu fosamprenavir ma' ritonavir 700mg / 100mg darbtejn kuljum, grupp sekondarju ta' ħames suġġetti pedjatriċi ta' bejn is-6 u <24 xahar li ħadu fosamprenavir / ritonavir 45/7 mg/kg darbtejn kuljum urew li għalkemm kien hemm żieda ta' bejn wieħed u ieħor 5 darbiet fid-doża ta' fosamprenavir u ritonavir fuq bażi ta' mg/kg, l-AUC (0-τ) ta' amprenavir fil-plażma kien bejn wieħed u ieħor 48% aktar baxx, Cmax 26% aktar baxx u Cτ 29% aktar baxx f'suġġetti pedjatriċi.
English: ГлаксоСмитКлайн ЕООД Teл.
Maltese: България ГлаксоСмитКлайн ЕООД
English: Amprenavir: Cmax ↓ 58% Amprenavir: AUC ↓ 63% Amprenavir: Cmin ↓ 65%
Maltese: AUC ↓ 63% Amprenavir: Cmin ↓ 65%
English: Elderly (over 65 years of age)
Maltese: Adult (>18 sena)
English: The relationship between in vitro anti-HIV-1 activity of amprenavir and the inhibition of HIV-1 replication in humans has not been defined.
Maltese: Ir relazzjoni bejn l-attività in vitro anti-HIV-1 ta' amprenavir u l-impediment tar-replikazzjoni ta' HIV-1
English: No studies have been done on the use of Telzir/ritonavir with other hormonal therapies, such as hormone replacement therapy (HRT).
Maltese: Ma saru l-ebda studji fuq l-użu ta' Telzir/ritonavir ma' terapiji ormonali oħra, bħal hormone replacement therapy (HRT).
English: (CYP induction by FPV/RTV)
Maltese: (Induzzjoni ta' CYP minn FPV/RTV)
English: Norethisterone: Cmax ↓ 38% Norethisterone: AUC ↓ 34% Norethisterone: Cmin ↓ 26
Maltese: Cmax ↓38% Norethisterone:
English: Lopinavir / ritonavir 533 mg/133 mg twice daily
Maltese: 533 mg/133 mg darbtejn kuljum
English: The benefit in this age group has mainly been derived from study APV29005, an open label 48 week study evaluating the pharmacokinetic profiles, safety, and antiviral activity of fosamprenavir with ritonavir administered twice daily to HIV 1 protease inhibitor experienced and naive patients 2 to 18 years of age.
Maltese: Il-benefiċċju f'dan il-grupp ħareġ primarjament minn studju APV29005, studju open label ta' 48 ġimgħa li jevalwa il-profili farmakokinetiċi, ta' sigurtà, u attività antivirali ta' fosamprenavir ma' ritonavir li ingħataw darbtejn kuljum lil pazjenti ta' bejn is-2 u t-18 il-sena bi u mingħajr esperjenza ta' inibitur tal-protease.
English: Amprenavir: Cmin ↔
Maltese: AUC ↔ Amprenavir: Cmin ↔
English: • The other ingredients are: hypromellose, sucralose, polysorbate 80, calcium chloride dihydrate,
Maltese: • Is-sustanzi l-oħra huma: hypromellose, sucralose, polysorbate 80, calcium chloride dihydrate, togħma artifiċjali ta' għeneb bubblegum, togħma ta' peppermint naturali, ilma purifikat,
English: Increased concentrations of HMG-CoA reductase inhibitors may cause myopathy, including rhabdomyolysis.
Maltese: reductase jistgħu jikkawżaw mijopatija, inkluż rabdomijoliżi.
English: Ketoconazole: Cmax ↑ 25% Ketoconazole: AUC ↑ 2.69fold.
Maltese: Cmax ↑ 25% Ketoconazole:
English: PDE5 inhibitors used for the treatment of erectile dysfunction: The use of Telzir concomitantly with PDE5 inhibitors (e.g. sildenafil, tadalafil, vardenafil) is not recommended (see section 4.5).
Maltese: impedituri PDE5 (eż. sildenafil, tadalafil, vardenafil) mhux rakkomandat (ara sezzjoni 4.5).
English: Phenytoin: Cmax ↓ 20% Phenytoin: AUC ↓ 22% Phenytoin: Cmin ↓ 29%
Maltese: AUC ↓ 22% Phenytoin:
English: In vivo a) ART-naïve or PI-naïve patients
Maltese: In vivo a) Pazjenti mingħajr esperjenza ART jew PI
English: Telzir 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: Telzir ma'ritonavir m'għandhomx jingħataw fl-istess ħin ma' prodotti mediċinali b'therapeutic windows dojoq li jiddependu ħafna mill-metaboliżmu ta' CYP2D6, e.ż. flecainide u propafenone (ara sezzjoni 4.5).
English: Key: 1GSS to OBT: Genotypic Sensitivity Score to Optimised Background.
Maltese: Sensitivity Score to Optimised Background).
English: Ritonavir dose (TWICE DAILY)
Maltese: Doża ta' Ritonavir (DARBTEJN KULJUM)
English: • Flare up of old infections
Maltese: • Re-attivazzjoni ta' infezzjonijiet tal-passat
English: • atorvastatin up to 20 mg per day (used to lower cholesterol)
Maltese: • dożi ta' atorvastatin akbar minn 20mg kuljum (użat biex ibaxxi l-kolesterol)
English: Pink film coated, capsule shaped, biconvex tablets, marked with GXLL7 on one side.
Maltese: Pilloli roża miksijin b'rita, għamla ta' kapsuli, imbuzzati fuq iż-żewġ naħat, immarkati GXLL7 fuq naħa waħda.
English: 25-O-desacetylrifabutin: Cmax ↑ 6-fold* 25-O-desacetylrifabutin: AUC(0-48) ↑ 11-fold* *compared to rifabutin 300 mg once daily
Maltese: 25-O-desacetylrifabutin: Cmax↑ 6-fold* 25-O-desacetylrifabutin:
English: Rash (see text below “rash/cutaneous reactions”)
Maltese: "raxx/reazzjonijiet tal-ġilda”)
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,
Maltese: L-algoritmu kurrenti (Lulju 2006) ANRS AC-11 għal fosamprenavir/ritonavir jiddefinixxi reżistenza bħala l preżenza ta' l-mutazzjonijiet V32I+I47A/V, jew I50V, jew almenu erba' mutazzjonijiet minn:
English: Reinforced monitoring of the International Normalised Ratio is recommended (see section 4.4).
Maltese: Hija rakkomandata sorveljanza rinforzata ta' lInternational Normalised Ratio (ara sezzjoni 4.4).
English: For adults with moderate hepatic impairment (Child-Pugh score: 7-9) the recommended dose is 450 mg fosamprenavir (i.e. 9 ml Telzir oral suspension) twice daily with 100 mg ritonavir once daily.
Maltese: Id-doża rakkomandata għall-adulti b'indeboliment tal-fwied moderat (Child-Pugh score: 7-9) hija ta' 450 mg fosamprenavir (i.e. 9ml ta' suspensjoni orali ta' Telzir) darbtejn kuljum ma' 100 mg ritonavir darba kuljum.
English: Bottle with 225 ml oral suspension A 10 ml graduated dosing syringe and adapter are also provided in the pack
Maltese: Flixkun ta' 225 ml suspensjoni orali Siringa immarkata ta' 10 ml għad-dożaġġ u adapter huma wkoll provduti fil-pakkett
English: Description of selected adverse reactions
Maltese: INIBITURI SELETTIVI
English: Phenytoin: Cmax ↓ 20% Phenytoin: AUC ↓ 22% Phenytoin: Cmin ↓ 29% (Modest induction of CYP3A4 by FPV/RTV)
Maltese: Cmin ↓ 29% (Induzzjoni modesta ta' CYP3A4 by FPV/RTV) Amprenavir: Cmax ↔
English: How to take Telzir
Maltese: Doża ta' Telzir
English: In a randomised open-label study (ESS100732 - KLEAN) in antiretroviral naïve patients, fosamprenavir (700 mg) co-administered with low dose ritonavir (100 mg) in a twice daily regimen including abacavir / lamivudine (600 mg / 300 mg) fixed dose combination tablet once daily showed comparable efficacy over 48 weeks to lopinavir / ritonavir (400 mg / 100 mg) given twice daily in combination with abacavir / lamivudine (600 mg / 300 mg once daily).
Maltese: kura antiretrovirali, fosamprenavir (700mg) flimkien ma' doża baxxa ta' ritonavir (100mg) darbtejn kuljum flimkien ma' pillola b'doża fissa ta' abacavir/lamivudine (600mg/300mg) darba kuljum wriet fuq 48 ġimgħa effikaċja komparabbli ma' lopinavir/ritonavir (400mg/100mg) darbtejn kuljum flimkien ma' abacavir/lamivudine (600mg/300mg darba kuljum).
English: Each ml of oral suspension contains 50 mg fosamprenavir as fosamprenavir calcium (equivalent to approximately 43 mg of amprenavir)
Maltese: U KWANTITATTIVA Kull ml ta' suspensjoni orali fih 50 mg ta' fosamprenavir bħala fosamprenavir calcium (ekwivalenti għal 43 mg ta' amprenavir)
English: You may get a skin rash.
Maltese: Ma ġewx studjati.
English: CCR5-receptor antagonists
Maltese: Antagonisti tar-riċettur CCR5
English: Treatment-emergent major protease or APV-associated mutations were observed in virus isolated from 1 patient in APV29005 and 6 patients from APV20003.
Maltese: Ġew osservati mutazzjonijiet assoċjati ma' APV jew protease maġġuri li ħarġu mit-trattament fil-virus iżolat minn pazjent 1 f'APV29005 u 6 pazjenti minn APV20003.
English: It may harm them, even if their signs of illness are the same as yours.
Maltese: kienu jinkludu: żieda ta' ALT (komuni), ta' AST (komuni), ta' serum lipase (komuni) u ta' trigliċeridi (komuni).
English: Diarrhoea
Maltese: Terapewtika
English: ANTIARRHYTHMICS
Maltese: ANTIPSIKOTIĊI
English: Fluticasone propionate: ↑ Intrinsic cortisol levels: ↓
Maltese: Fluticasone propionate:
English: Atorvastatin 10 mg once daily for 4 days
Maltese: 10 mg darba kuljum għal 4
English: - alfuzosin (used to treat a prostate problem) - astemizole or terfenadine (commonly used to treat allergy symptoms - these medicines may be available without prescription) - pimozide (used to treat schizophrenia) - quetiapine (used to treat schizophrenia, bipolar disorder and major depressive disorder) - lurasidone (used to treat schizophrenia and bipolar disorder) - cisapride (used to relieve indigestion) - ergot derivatives (used to treat headaches) - rifampicin (used to treat tuberculosis) - amiodarone, quinidine, flecainide and propafenone (heart medicines) - bepridil (used to treat high blood pressure) - oral midazolam or oral triazolam (used to treat anxiety) - products containing St John's wort (Hypericum perforatum) - lovastatin, simvastatin (used to lower cholesterol) - sildenafil if used to treat pulmonary arterial hypertension, (a condition affecting the blood vessels to your lungs) - paritaprevir (used to treat hepatitis C virus infection)
Maltese: - astemizole jew terfenadine (li komunement jintużaw biex jikkuraw sintomi ta' allerġija - dawn il mediċini tista' ssibhom mingħajr riċetta) - pimozide (li jintuża biex jikkura skiżofrenija) - quetiapine (li jintuża għall-kura tal-iskiżofrenja, disturb bipolari u disturb depressiv maġġuri) - lurasidone (li jintuża għall-kura ta' skiżofrenja u disturb bipolari) - cisapride (li jintuża biex jalljeva indigistjoni) - derivattivi ta' ergot (li jintuża biex jikkura uġigħ ta' ras) - rifampicin (li jintuża biex jikkura tuberculożi)
English: Table 1 Efficacy Outcome at Week 48 in ESS100732 (ART-Naïve Patients)
Maltese: Tabella 1 Riżultat tal-Effikaċja fil-Ġimgħa 48 f'ESS100732 (Pazjenti mingħajr esperjenza ta'
English: (Modest induction of CYP3A4 by FPV/RTV)
Maltese: (Induzzjoni modesta ta' CYP3A4 by FPV/RTV)
English: Daclatasvir
Maltese: Simeprevir Daclatasvir
English: Antiviral activity according to genotypic/phenotypic resistance
Maltese: Attività antivirali skont ir-reżistenza ġenotipika/fenotipika
English: In the studies of PI-experienced adult 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: 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: If Telzir/ritonavir is coadministered with parenteral midazolam, it should be done in an intensive care unit (ICU) or similar setting which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation.
Maltese: Jekk Telzir/ritonavir jingħata flimkien ma' midazolam fil vina, dan għandu jsir f'taqsima ta' kura intensiva (ICU) jew ambjent simili li jassigura sorveljanza klinika mill-viċin u trattament mediku addattat f'kaz ta' dipressjoni respiratorju u/ jew sedazzjoni fit-tul.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterium infections, and Pneumocystis carinii pneumonia.
Maltese: Eżempji relevanti jinkludu retinite minħabba cytomegalovirus, infezzjonijiet bil mycobacterium mifruxa jew lokaliżżati u pulmonite bi Pneumocystis carinii.
English: ≤ 200 mg once daily
Maltese: ≤ 200 mg darba kuljum
English: The recommended dose is 14 ml Telzir oral suspension (700 mg fosamprenavir) twice daily with 100 mg ritonavir (as capsule or oral solution) twice daily.
Maltese: Id-doża rakkomandata hi ta' 14ml ta' suspensjoni orali ta' Telzir (700mg fosamprenavir) darbtejn kuljum ma' 100 mg ritonavir (bħala kapsula jew soluzzjoni orali) darbtejn kuljum.
English: Zidovudine
Maltese: Didanosine
English: HIV can become resistant to anti-HIV medicines.
Maltese: HIV jista' jsir reżistenti għal mediċini anti-HIV.
English: • maraviroc (used to treat HIV infection)
Maltese: • maraviroc (jintuża għall-kura ta' infezzjoni tal-HIV)
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: f'ċelluli infettati b'mod akut u kienet 0.41 µM f'ċelluli infettati b'mod kroniku (1 µM=0.50µg/ml).
English: In a randomised open-label study (APV30003) in protease inhibitor experienced patients with virological failure (less than or equal to two PIs) the fosamprenavir with ritonavir (700 / 100 mg twice daily or 1400 / 200 mg once daily) did not demonstrate non-inferiority to lopinavir / ritonavir with regard to viral suppression as measured by the average area under the curve minus baseline (AAUCMB) for plasma HIV-1 RNA over 48 weeks (the primary end point).
Maltese: Fi studju open-label randomised (APV30003) fuq pazjenti li kelhom l-impeditur protease b'falliment viroloġiku (inqas minn jew ugwali għal żewġ PIs) fosamprenavir flimkien ma' ritonavir (700/100 mg darbtejn kuljum jew 1400/200 mg darba kuljum) ma wrewx nuqqas ta' non-inferjorità għal lopinavir/ritonavir fir-rigward ta' soppressjoni virali kif imkejla mill-medja ta' l-erja ta' taħt il-kurva bil-linja bażi imnaqqsa (AAUCMB) għal HIV-1 RNA fil-plażma matul 48 ġimgħa (l-endpoint primarju).
English: Non-inferiority was demonstrated between fosamprenavir co-administered with ritonavir and lopinavir / ritonavir based on the proportions of patients achieving plasma HIV-1 RNA levels < 400 copies/ml at 48 weeks (primary endpoint).
Maltese: Intweriet nuqqas ta' inferjorità bejn fosamprenavir flimkien ma' ritonavir u lopinavir/ritonavir, ibbażat fuq il-proporzjon ta' pazjenti li jilħu livelli ta' HIV-1 RNA fil-plażma ta' <400 kopji /ml fit-48 ġimgħa
English: A dose reduction of the glucocorticoid with close monitoring of local and systemic effects or a switch to a glucocorticoid, which is not a substrate for CYP3A4 (e.g. beclomethasone) should be considered.
Maltese: effetti lokali jew sistemiċi għandha tiġi ikkonsidrata jew qlib għal glukokortikojde li ma huwiex substrat għal for CYP3A4 (e.ż. beclomethasone).
English: Each film-coated tablet contains 700 mg fosamprenavir as fosamprenavir calcium (equivalent to approximately 600 mg of amprenavir)
Maltese: Kull pillola fiha 700mg ta' fosamprenavir bħala fosamprenavir calcium (ekwivalenti għal bejn wieħed u ieħor 600mg ta' amprenavir)
English: Amprenavir: Cmax ↓ 35% Amprenavir: AUC ↓ 18% Amprenavir: Cmin (C12h) ↔
Maltese: AUC ↓ 18% Amprenavir: Cmin (C12h) ↔