FrancophonIA/ELRC3.0 huggingface dataset:
English: General side effects: rash or itching of the skin.
Maltese: Effetti sekondarji ġenerali: raxx jew ħakk tal-ġilda.
English: Not known macular oedema, lid sulcus deepened
Maltese: OĦRA, JEKK MEĦTIEĠA
English: The studies used in the model were two dose response trials, one Phase III study using IZBA and a paediatric study using TRAVATAN (travoprost 40 micrograms/mL eye drops, solution).
Maltese: III bl-użu ta' IZBA u studju pedjatriku li juża TRAVATAN (travoprost 40 mikrogramma/mL qtar għall-għajnejn, soluzzjoni).
English: Studies in rabbits have shown peak concentrations of 20 ng/g of the free acid in aqueous humour one to two hours after topical dosing of travoprost 40 µg/mL eye drops, solution.
Maltese: Studji fil-fniek urew konċentrazzjonijiet massimi ta' 20 ng/g tal-aċidu ħieles flaqueous humour siegħa sa sagħtejn wara l-għoti topiku ta' travoprost 40 µg/mL qtar għall-għajnejn, soluzzjoni.
English: IZBA contains travoprost, one of a group of medicines called prostaglandin analogues.
Maltese: IZBA fih travoprost, wieħed minn grupp ta' mediċini li jissejħu analogi ta' prostaglandin.
English: General side effects: depression, anxiety, insomnia, sensation of false movement, ringing in ears, chest pain, abnormal heart rhythm, increased heart beat, worsening of asthma, diarrhoea, nose bleeds, abdominal pain, nausea, vomiting, itching, abnormal hair growth, painful or involuntary urination, increase in prostate cancer marker.
Maltese: Effetti sekondarji ġenerali: depressjoni, ansjetà, nuqqas ta' rqad, sensazzjoni ta' moviment falz, żarżir fil-widnejn, uġigħ fis-sider, ritmu tal-qalb mhux normali, żieda fit-taħbit tal-qalb, deterjorament talażżma, dijarea, fsada mill-imnieħer, uġigħ addominali, dardir, rimettar, ħakk, tkabbir ta' xagħar mhux normali, uġigħ meta tgħaddi l-awrina jew awrina involontarja, żieda fil-markatur tal-kanċer talprostata.
English: Effects in the eye: corneal disorder, eye inflammation, iris inflammation, inflammation inside the eye, eye surface inflammation with/out surface damage, sensitivity to light, eye discharge, eyelid inflammation, eyelid redness, swelling around the eye, eyelid itching, blurred vision, increased tear production, infection or inflammation of the conjunctiva (conjunctivitis), abnormal turning outward of the lower eyelid, clouding of the eye, eyelid crusting, growth of eyelashes.
Maltese: Effetti fl-għajn: infjammazzjoni ġewwa l-għajn, infjammazzjoni tas-superfiċje tal-għajn bi/bla ħsara fis-superfiċje, infjammazzjoni tal-kpiepel tal-għajnejn, infjammazzjoni tal-konġuntiva, uġigħ fl-għajn, sensittività għad-dawl, vista mċajpra jew mhux normali, nefħa jew qxur fuq il-kpiepel tal-għajnejn, tnixxija mill-għajn, kulur aktar skur tal-ġilda madwar l-għajn(ejn), tkabbir u tħaxxin tax-xagħar talgħajnejn
English: Travoprost 40 µg/mL eye drops, solution has been studied in patients with mild to severe hepatic impairment and in patients with mild to severe renal impairment (creatinine clearance as low as 14 mL/min).
Maltese: Travoprost 40 µg/mL qtar għall-għajnejn, soluzzjoni, kien studjat f'pazjenti b'indeboliment ħafif sa sever tal-fwied u f'pazjenti b'indeboliment ħafif sa sever tal-kliewi (tneħħija tal-krejatinina b'livell baxx sa 14 mL/min).
English: In addition, the following side effects have been observed with another medicine containing a higher strength of travoprost (40 micrograms/mL):
Maltese: Barra dan, l-effetti sekondarji li ġejjin kienu osservati b'mediċina oħra li fiha qawwa ogħla ta' travoprost (40 mikrogramma/mL):
English: IZBA 30 micrograms/mL eye drops, solution
Maltese: IL-PRODOTT MEDIĊINALI IZBA 30 mikrogramma/mL qtar għall-għajnejn, soluzzjoni.
English: Low levels of radioactivity were measured in amniotic fluid and foetal tissues of pregnant rats administered
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TAL-UŻU SIGUR U EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: However, travoprost 40 µg/mL has been studied in patients with mild to severe hepatic impairment and in patients with mild to severe renal impairment (creatinine clearance as low as 14 mL/min).
Maltese: Madankollu, travoprost 40 µg/mL kien studjat f'pazjenti b'indeboliment ħafif sa sever tal-fwied u f'pazjenti b'indeboliment ħafif sa sever tal-kliewi (tneħħija tal-krejatinina b'livell baxx sa 14 mL/min).
English: suspension : 2.5 ml emulsion : 2.5 ml
Maltese: suspensjoni : 2.5 ml emulsjoni : 2.5 ml
English: 50 vials (suspension) 2 x 25 vials (emulsion)
Maltese: 50 kunjett (suspensjoni) + 2 x 25 kunjett (emulsjoni)
English: Intramuscular use suspension (H1N1): vial (glass); emulsion (adjuvant): vial (glass)
Maltese: Jingħata filmuskolu suspensjoni (H1N1): kunjett (ħġieġ) emulsjoni (suppliment): kunjett (ħġieġ)
English: Suspension and emulsion for emulsion for injection
Maltese: Suspensjoni u emulsjoni għal emulsjoni għallinjezzjoni
English: EMEA Number
Maltese: Numru tal-proċedura ta' lEMEA
English: Contrada Fontana del Ceraso 03012 Anagni (FR) Italy
Maltese: Contrada Fontana del Ceraso 03012 Anagni (FR) L-Italja
English: c Ritonavir oral solution.
Maltese: c Ritonavir soluzzjoni orali.
English: Difference estimate e
Maltese: Stima tad-differenza e
English: Date of latest renewal: 02 March 2009
Maltese: Data tal-aħħar tiġdid: 02 ta' Marzu 2009
English: Immunosuppressants Cyclosporin Tacrolimus Sirolimus
Maltese: Immunosuppressanti Cyclosporin Tacrolimus Sirolimus
English: Expected: ↔ Atazanavir ↔ Ritonavir
Maltese: Mistenni: ↔ Atazanavir ↔ Ritonavir
English: d Confidence interval.
Maltese: d Intervall ta' konfidenza.
English: REYATAZ contains lactose.
Maltese: REYATAZ fih lactose.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Maltese: IDENTIFIKATUR Uniku - Barcode 2d Barcode 2D li jkollu l-identifikatur uniku inkluż.
English: common: rash; uncommon: erythemia multiforme a,b
Maltese: komuni: raxx; mhux komuni: eritema multiforme a,b
English: 4.6 Fertility, pregnancy and lactation
Maltese: 4.6 Fertilità, tqala u treddigħ Tqala
English: d Ritonavir oral solution or capsule/tablet.
Maltese: d Ritonavir soluzzjoni orali jew kapsula/pillola.
English: Geometric mean (CV%)
Maltese: Medja ġeometrika (CV %)
English: Without Tenofovir
Maltese: Mingħajr Tenofovir
English: Desacetyl-diltiazem AUC ↑165% Desacetyl-diltiazem Cmax ↑172% Desacetyl-diltiazem Cmin ↑121%
Maltese: AUC ta' Desacetyl-diltiazem ↑165 % Cmax ta' Desacetyl-diltiazem ↑172 % Cmin ta' Desacetyl-diltiazem ↑121 %
English: s r.o.
Maltese: s r.o. TEL:
English: 1.3 g of sucrose per sachet.
Maltese: 1.3 g ta' sucrose f'kull qartas.
English: 14-OH clarithromycin 14-OH clarithromycin AUC ↓70% 14-OH clarithromycin Cmax ↓72% 14-OH clarithromycin Cmin ↓62%
Maltese: 14-OH clarithromycin AUC ta' 14-OH clarithromycin ↓70 % Cmax ta' 14-OH clarithromycin ↓72 % Cmin ta' 14-OH clarithromycin ↓62 %
English: REYATAZ is an antiviral (or antiretroviral) medicine.
Maltese: REYATAZ huwa mediċina antivirali (jew antiretrovirali).
English: SEDATIVES Benzodiazepines Midazolam Triazolam
Maltese: SEDATTIVI Benzodiazepines Midazolam Triazolam
English: Table 2: Interactions between REYATAZ and other medicinal products
Maltese: Tabella 2: Interazzjonijiet bejn REYATAZ u prodotti mediċinali oħra
English: FC susceptibility in cell culture relative to the wild-type reference was assayed using PhenoSenseTM (Monogram Biosciences, South San Francisco, California, USA)
Maltese: Suxxettibilità FC fil-kultura taċ-ċellula a paragun mar-referenza tal-wild type kienet evalwata permezz ta' PhenoSenseTM (Monogram Biosciences, South San Francisco, California, USA)
English: - The active substance is atazanavir.
Maltese: - Is-sustanza attiva hija atazanavir.
English: LIST OF EXCIPIENTS Contains aspartame and sucrose.
Maltese: TA' EĊĊIPJENTI Fih aspartame u sucrose.
English: Sildenafil, tadalafil, vardenafil Sildenafil, tadalafil, and vardenafil are metabolised by CYP3A4.
Maltese: Sildenafil, tadalafil, vardenafil Sildenafil, tadalafil u vardenafil huma metabolizzati minn CYP3A4.
English: Total rifabutin and 25-O-desacetyl-rifabutin AUC ↑119% (↑78% ↑169%).
Maltese: Total ta' rifabutin u AUC ta' 25-O-desacetylrifabutin ↑119 % (↑78 % ↑169 %).
English: The M184I/V substitution emerged in 5/26 REYATAZ/ritonavir and 7/26 lopinavir/ritonavir virologic failure patients, respectively.
Maltese: Is-sostituzzjoni ta' M184I/V ħarġet f'5/26 REYATAZ/ritonavir u 7/26 pazjenti lopinavir/ritonavir/viroloġiċi li fallew, rispettivament.
English: Grade 3 or 4 elevation of total bilirubin was noted in 37% (6% Grade 4).
Maltese: Żieda ta' bilirubin totali ta' grad 3 jew 4 ġiet innotata 37 % (6 % Grad 4).
English: There were no cases of lactic acidosis observed in the clinical trial AI424-182.
Maltese: Ma kien hemm lebda każ ta' aċidożi lattika fil-prova klinika AI424-182.
English: Aspartame is a source of phenylalanine.
Maltese: Aspartame huwa sors ta' phenylalanine.
English: Excipient with known effect: 164.36 mg of lactose per capsule.
Maltese: Eċċipjent b'effett magħruf: 164.36 mg ta' lactose kull kapsula.
English: The proportion of patients with HIV RNA < 400 copies/ml were 53% and 43% for ATV/RTV and 54% and 46% for LPV/RTV at weeks 48 and 96 respectively.
Maltese: Il-proporzjon ta' pazjenti b'HIV RNA <400 kopja/ml kienu 53 % u 43 % għal ATV/RTV u 54 % u 46 % għal LPV/RTV fil-ġimgħat 48 u 96 rispettivament.
English: uncommon: gynaecomastia
Maltese: mhux komuni: ginekomastja
English: Week 48: 1.7% [-3.8%, 7.1%] Week 96: 6.1% [0.3%, 12.0%]
Maltese: Ġimgħa 48: 1.7 % [-3.8 %, 7.1 %] Ġimgħa 96: 6.1 % [0.3 %,12.0
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturers responsible for batch release Bristol-Myers Squibb S.r.l., Contrada Fontana del Ceraso, 03012 Anagni (FR), Italy Swords Laboratories T/A Lawrence Laboratories, Unit 12, The Distribution Centre, Shannon Industrial Estate, Shannon, Co. Clare, Ireland
Maltese: MILL-ĦRUĠ TAL-LOTT Isem u indirizz tal-manifatturi responsabbli mill-ħruġ tal-lott Bristol-Myers Squibb S.r.l., Contrada Fontana del Ceraso, 03012 Anagni (FR), L-Italja Swords Laboratories T/A Lawrence Laboratories, Unit 12, The Distribution Centre, Shannon Industrial Estate, Shannon, Co. Clare, L-Irlanda
English: AI424-397 (PRINCE I): In paediatric patients from 3 months to less than 6 years of age
Maltese: AI424-397 (PRINCE I): F'pazjenti pedjatriċi li għandhom bejn 3 xhur u inqas minn 6 snin
English: REYATAZ 100 mg hard capsules REYATAZ 150 mg hard capsules REYATAZ 200 mg hard capsules REYATAZ 300 mg hard capsules
Maltese: REYATAZ 100 mg kapsuli ibsin REYATAZ 150 mg kapsuli ibsin REYATAZ 200 mg kapsuli ibsin REYATAZ 300 mg kapsuli ibsin
English: atazanavir AUC ↓ 35% atazanavir Cmax ↓ 25% atazanavir Cmin ↓ 49%
Maltese: atazanavir AUC ↓ 35% Cmax ta' atazanavir ↓ 25% Cmin ta' atazanavir ↓ 49%
English: Excipient with known effect: 82.18 mg of lactose per capsule.
Maltese: Eċċipjent b'effett magħruf: 82.18 mg ta' lactose kull kapsula.
English: ANTINEOPLASTICS AND IMMUNOSUPRESSANTS Antineoplastics
Maltese: U IMMUNOSUPPRESSANTI Antineoplastiċi
English: Tel: + 386 1 2355 100
Maltese: s r.o. Tel: + 386 1 2355 100
English: Excipient with known effect: 63 mg of aspartame; 1305.15 mg of sucrose per sachet (1.5 g oral powder).
Maltese: Eċċipjent b'effett magħruf: 63 mg ta' aspartame; 1,305.15 mg ta' sucrose f'kull qartas (1.5 g trab orali).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 02 March 2004
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 02 ta' Marzu 2004
English: Table 5: Efficacy Outcomes in Study 138 a Parameter
Maltese: Riżultati ta' l-effikaċja fi Studju 138a Parametru
English: CD4 count <50 cells/mm3
Maltese: Għadd CD4 <50 ċellula/mm3
English: rare: Stevens-Johnson syndromea,b, vesiculobullous rash, eczema, vasodilatation
Maltese: rari: is-sindromu ta' Stevens-Johnsona,b, raxx bl-infafet, ekżema, vażodilazzjoni
English: One pack size is available: 1 carton with 30 sachets.
Maltese: Huwa disponibbli daqs tal-pakkett wieħed: kartuna bi 30 qartas.
English: Excipient with known effect: 109.57 mg of lactose per capsule.
Maltese: Eċċipjent b'effett magħruf: 109.57 mg ta' lactose kull kapsula.
English: Week 48: -3% [-7.6%, 1.5%] Week 96: 2.2% [-2.3%, 6.7%] HIV RNA <50 copies/ml, % by Baseline Characteristicd HIV RNA <100,000 copies/ml
Maltese: Ġimgħa 96: 2.2% [-2.3%, 6.7%] HIV RNA <50 kopja/ml, % skont il-Karattteristika tal-Linjabażid HIV RNA <100,000 kopja/ml
English: Norbuprenorphine AUC ↑105% Norbuprenorphine Cmax ↑61% Norbuprenorphine Cmin ↑101%
Maltese: AUC ta' Norbuprenorphine ↑105 % Cmax ta' Norbuprenorphine ↑61 % Cmin ta' Norbuprenorphine ↑101 %
English: Frequency is defined using the following convention: 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), very rare (< 1/10,000).
Maltese: Il-frekwenza hija definita bl-użu ta' din ilkonvenzjoni: 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), rari ħafna (<1/10,000).
English: 80 mgb
Maltese: 80 mg b
English: At least 5 to less than 15
Maltese: Tal-inqas 5 sa inqas minn 15
English: Metabolites are then excreted in the bile as either free or glucuronidated metabolites.
Maltese: Il-metaboliti joħorġu fil-bili kemm bħala metaboliti liberi jew bħala metaboliti glukuronidati.
English: boceprevir AUC ↔5% boceprevir Cmax ↔7% boceprevir Cmin ↔18%
Maltese: AUC ta' Boceprevir ↔5% Cmax ta' Boceprevir ↔7% Cmin ta' Boceprevir ↔18%
English: ritonavir AUC ↓ 36% ritonavir Cmax ↓ 27% ritonavir Cmin ↓ 45%
Maltese: ritonavir AUC ↓ 36% ritonavir Cmax ↓ 27% Cmin ta' Ritonavir ↓45 %
English: (See sections 4.2 and 4.4.)
Maltese: (Ara sezzjonijiet 4.2 u 4.4).
English: Voriconazole AUC ↑561% (↑451% Voriconazole Cmax ↑438% (↑355% Voriconazole Cmin ↑765% (↑571%
Maltese: AUC ta' Voriconazole ↑561 % Cmax ta' Voriconazole ↑438 % (↑355 % Cmin ta' Voriconazole ↑765 % (↑571 %
English: The fluticasone propionate plasma levels increased significantly, whereas the intrinsic cortisol levels decreased by approximately 86% (90% confidence interval 82%-89%).
Maltese: Il-livelli ta' fluticasone propionate filplażma żdiedu b'mod sinifikanti, filwaqt li l-livelli intrinsiċi tal-cortisol naqsu b'madwar 86 % (90 % intervall ta' fiduċja 82-89 %).
English: Calcium channel blockers Bepridil
Maltese: Imblokkaturi tal-kanali tal-kalċju Bepridil
English: b Ten patients had baseline phenotypic resistance to atazanavir + ritonavir (fold change [FC]>5.2).
Maltese: b Għaxar pazjenti kellhom reżistenza fenotipika tal-linjabażi għal atazanavir + ritonavir (bidla tal-fold [FC]>5.2).
English: 63 mg of aspartame per sachet.
Maltese: 63 mg ta' aspartame għal kull qartas.
English: Antiviral activity in vitro: atazanavir exhibits anti-HIV-1 (including all clades tested) and anti-HIV-2 activity in cell culture.
Maltese: Attività antivirali in vitro: atazanavir jesibixxi anti-HIV-1 (inkluż l-gruppi kollha ta' organiżmi li evolvew minn antenat wieħed li ġew ittestjati) u anti-HIV 2 attività f'kultura ta' ċelloli.
English: c PI major L24I, D30N, V32I, L33F, M46IL, I47AV, G48V, I50LV, F53LY,I54ALMSTV, L76V, V82AFLST, I84V, N88DS, L90M; PI minor: L10CFIRV, V11I, E35G, K43T, Q58E, A71ILTV, G73ACST, T74P, N83D, L89V.
Maltese: L24I, D30N, V32I, L33F, M46IL, I47AV, G48V, I50LV, F53LY, I54ALMSTV, L76V, V82AFLST, I84V, N88DS, L90M; PI minuri: L10CFIRV, V11I, E35G, K43T, Q58E, A71ILTV, G73ACST, T74P, N83D, L89V.
English: Ethinyloestradiol 35 µg + norethindrone (atazanavir 400 mg once daily)
Maltese: Ethinyloestradiol 35 µg + norethindrone (atazanavir 400 mg darba kuljum)
English: - The other ingredients are aspartame (E951), sucrose and orange vanilla flavour.
Maltese: - L-ingredjenti l-oħra huma aspartame (E951), sucrose u togħma ta' larinġ u vanilla.
English: PULMONARY ARTERIAL HYPERTENSION PDE5 Inhibitors
Maltese: PRESSJONI GĦOLJA ARTERJALI PULMONARI Inibituri PDE5
English: The geometric mean (CV%) for atazanavir Cmin and AUC was 654 (76%) ng/ml and 44185 (51%) ng•h/ml, respectively.
Maltese: Il-medja ġeometrika (CV %) għal atazanavir Cmin u AUC kienet 654 (76 %) ng/ml u 44,185 (51 %) ng•h/ml, rispettivament.
English: HCV Protease Inhibitors
Maltese: Inibituri tal-Protease HCV
English: 100 mgc aEach sachet contains 50 mg of REYATAZ bRitonavir oral solution cRitonavir oral solution or capsule/tablet
Maltese: 100 mgc aKull qartas fih 50 mg ta' REYATAZ bRitonavir soluzzjoni orali cRitonavir soluzzjoni orali jew kapsula/pillola
English: In clinical studies AI424-397 and AI424-451, paediatric patients 3 months to less than 11 years of age had a mean duration of treatment with REYATAZ oral powder of 80 weeks.
Maltese: Fl-istudji kliniċi AI424-397 u AI424-451, il-pazjenti pedjatriċi li kellhom minn 3 xhur sa inqas minn 11-il xahar ta' età kellhom durata ta' kura medja b'REYATAZ trab orali ta' 80 ġimgħa.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/267/001-006; 008-011
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/03/267/001-006; 008-011
English: Elimination: following a single 400 mg dose of 14C-atazanavir, 79% and 13% of the total radioactivity was recovered in the faeces and urine, respectively.
Maltese: Eliminazzjoni: wara doża waħda ta' 400 mg ta' 14C-atazanavir, 79 % u 13 % tat-total tar-radjuattività ġie rkuprat rispettivament fil-purgar u fl-urina.
English: Pharmacotherapeutic group: antivirals for systemic use, protease inhibitors, ATC code: J05AE08
Maltese: Kategorija farmakoterapewtika: antivirali għal użu sistemiku, inibituri tal-proteasi, kodiċi ATC:
English: REYATAZ + saquinavir was shown to be inferior to lopinavir + ritonavir.
Maltese: REYATAZ + saquinavir jidher li hu inferjuri għal lopinavir + ritonavir.
English: Consistent results were obtained with the last observation carried forward method of analysis (time-averaged difference of 0.11, 97.5% confidence interval [-0.15, 0.36]).
Maltese: Kien hemm riżultati konsistenti bilmetodu ta' analiżi fejn l-aħħar osservazzjoni ġiet mgħoddija ‘l quddiem (differenza fuq medja ta' żmien ta' 0.11, intervall ta' fiduċja 97.5 % [-0.15, 0.36]).
English: 100 mg a Ritonavir capsules, tablets or oral solution.
Maltese: 100 mg a Kapsuli, pilloli jew soluzzjoni orali ta' ritonavir.
English: How to store REYATAZ 6.
Maltese: Kif taħżen REYATAZ 6.
English: 50 to <100 cells/mm3
Maltese: 50 sa <100 ċellula/mm3
English: Each carton contains 30 sachets.
Maltese: Kull kartuna fiha 30 qartas.
English: b Cmin is concentration 24 hours post-dose.
Maltese: b Cmin hija konċentrazzjoni 24 siegħa wara d-doża.
English: Carton Bottle pack (1 bottle): 30 hard capsules Carton Bottle pack: (3 bottles): 3 x 30 hard capsules (3 bottles of 30 hard capsules) Label Bottle pack: 30 hard capsules
Maltese: Pakkett tal-Kartun tal-Flixkun (flixkun 1): 30 kapsula iebsa Pakkett tal-Kartun tal-flixkun: (3 fliexken): 3 x 30 kapsula iebsa (3 fliexken ta' 30 kapsula iebsa) Tikketta tal-Pakkett tal-fliexken: 30 kapsula iebsa
English: 100 mg at least 35
Maltese: 100 mg tal-inqas 35
English: Per protocol analysise
Maltese: Analiżi skont ilprotokolle
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia.
Maltese: Eżempji relevanti huma retinite taċ-ċitomegalovirus, infezzjonijiet mikobatterjali ġeneralizzati u/jew fokali, u pulmonite Pneumocystis jirovecii.
English: In clinical trial AI424-182 REYATAZ/ritonavir (300/100 mg or 400/100 mg) in combination with zidovudine/lamivudine was administered to 41 pregnant women during the second or third trimester.
Maltese: Fi prova klinika AI424-182, REYATAZ/ritonavir (300/100 mg jew 400/100 mg) f'kombinazzjoni ma' zidovudine/lamivudine ngħata lil 41 mara tqila matul it-tieni u t-tielet trimestru.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Maltese: IDentifikatur uniku - data li tinqara mill-bniedem PC:
English: Buprenorphine AUC ↑67% Buprenorphine Cmax ↑37% Buprenorphine Cmin ↑69%
Maltese: AUC ta' Buprenorphine ↑67 % Cmax ta' Buprenorphine ↑37 % Cmin ta' Buprenorphine ↑69%
English: - The other ingredients are crospovidone, lactose monohydrate, and magnesium stearate.
Maltese: - L-ingredjenti l-oħra huma crospovidone, lactose monohydrate u magnesium stearate.
English: 100 to <200 cells/mm3
Maltese: 100 sa <200 ċellula/mm3
English: Atazanavir binds to both alpha-1-acid glycoprotein (AAG) and albumin to a similar extent (89% and 86%, respectively, at 1,000 ng/ml).
Maltese: Atazanavir jingħaqad kemm mal-glikoproteina alpha-1-acid (AAG) kif ukoll ma' l-albumina bl-istess ammont (rispettivament 89 % u 86 % f'1,000 ng/ml).
English: Blister pack: 30 hard capsules
Maltese: Pakkett tal-folji: 30 kapsuli ibsin
English: Elbasvir Cmax: ↑315% (↑246% ↑397%) Elbasvir Cmin: ↑545% (↑451% ↑654%)
Maltese: ↑315% (↑246% Cmin ta' Elbasvir: ↑545% (↑451%
English: Other marked clinical laboratory abnormalities (Grade 3 or 4) reported in ≥ 2% of patients receiving regimens containing REYATAZ and one or more NRTIs included: elevated creatine kinase (7%), elevated alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/SGPT) (5%), low neutrophils (5%), elevated aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT) (3%), and elevated lipase (3%).
Maltese: Anormalitajiet oħra tal-laboratorju (Grad 3 jew 4) li ġew irrapportati f'≥2 % tal-pazjenti li jirċievu lkura bi REYATAZ flimkien ma' NRTI wieħed jew iżjed inkludew: kreatina kinasi elevata (7 %), serum aminotransferasi/glutamikpiruvik transaminasi elevata (ALT/SGPT) (5 %), newtrofili baxxi (5 %), serum aspartate aminotransferasi/glutamic-oxaloacetic transaminasi (AST/SGOT) (3 %) u lipadosi elevati (3 %).
English: , toxic skin eruptions a,b
Maltese: , anġjoedema a,
English: High doses of ketoconazole and itraconazole (>200 mg/day) are not recommended.
Maltese: għoljin ta' ketoconazole u itraconazole (>200 mg/kuljum).
English: Integrase Inhibitors Raltegravir 400 mg twice daily (atazanavir/ritonavir)
Maltese: Inibituri tal-Integrase Raltegravir 400 mg darbtejn kuljum (atazanavir/ritonavir)
English: Clarithromycin AUC ↑94% (↑75% Clarithromycin Cmax ↑50% (↑32% Clarithromycin Cmin ↑160% (↑135%
Maltese: AUC ta' Clarithromycin ↑94 % Cmax ta' Clarithromycin ↑50% (↑32% Cmin ta' Clarithromycin ↑160 %
English: Table 6: Efficacy Outcomes at Week 48a and at Week 96 (Study 045) Parameter
Maltese: Tabella 6: Riżultati ta' Effikaċja f'Ġimgħa 48a u f'Ġimgħa 96 (Studju 045) Parametru
English: Non-nucleoside reverse transcriptase inhibitors (NNRTIs) Efavirenz 600 mg once daily (atazanavir 400 mg once daily with ritonavir 100 mg once daily)
Maltese: Non-nucleoside reverse transcriptase inhibitors (NNRTIs) Efavirenz 600 mg darba kuljum (atazanavir 400 mg darba kuljum ma' ritonavir 100 mg darba kuljum)
English: REYATAZ oral powder contains 1305.15 mg of sucrose per sachet.
Maltese: REYATAZ trab orali fih 1,305.15 mg ta' sucrose f'kull qartas.
English: REYATAZ 300 mg hard capsules Capsule contents: crospovidone, lactose monohydrate and magnesium stearate
Maltese: Kontenut tal-kapsula: crospovidone, lactose monohydrate u magnesium stearate
English: Each carton contains 60 x 1 capsules; 10 blister cards of 6 x 1 capsules each in Alu/Alu perforated unit dose blisters.
Maltese: Kull kartuna fiha 60 x 1 kapsula; 10 folji ta' 6 x 1 kapsula kull waħda f'folji ta' Alu/Alu ipperforat f'doża ta' unità waħda.
English: During in vitro studies, cloned human cardiac potassium channel (hERG), was inhibited by 15% at a concentration (30 μM) of atazanavir corresponding to 30 fold the free drug concentration at Cmax in humans.
Maltese: Waqt studji in vitro, materjal kardijaku uman ikklonjat tal-potassju (hERG), kien impedut bi 15 % f'konċentrazzjoni (30 μM) ta' atazanavir li tikkorrispondi għal 30-darba l-konċentrazzjoni ta' droga libera Cmax fin-nies.
English: Nevirapine AUC ↑26% (↑17% ↑36%) Nevirapine Cmax ↑21% (↑11% ↑32%) Nevirapine Cmin ↑35% (↑25% ↑47%)
Maltese: AUC ta' Nevirapine ↑26 % (↑17 % Cmax ta' Nevirapine ↑21 % (↑11 % Cmin ta' Nevirapine ↑35 % (↑25 %
English: Didanosine (buffered tablets) 200 mg/stavudine 40 mg, both single dose (atazanavir 400 mg single dose)
Maltese: Didanosine (pilloli buffered) 200 mg/stavudine 40 mg, ittnejn doża waħda (atazanavir 400 mg doża waħda)