FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment of overdose with REYATAZ should consist of general supportive measures, including monitoring of vital signs and electrocardiogram (ECG), and observations of the patient's clinical status.
Maltese: Il-kura għal doża eċċessiva ta' REYATAZ għandha tkun magħmula minn kull mezz ta' għajnuna, inkluż il-monitoraġġ ta' sinjali vitali u elettrokardjogramm (ECG), u osservazzjonijiet tal-kondizzjoni klinika tal-pazjent.
English: Interactions between atazanavir/ritonavir and protease inhibitors, antiretroviral agents other than protease inhibitors, and other non-antiretroviral medicinal products are listed in the table below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”).
Maltese: L-interazzjonijiet bejn atazanavir/ritonavir u inibituri ta' protease, aġenti antiretrovirali minbarra inibituri ta' protease, u prodotti mediċinali oħra huma elenkati fit-tabella ta' hawn isfel (żieda hija indikata bħala “↑”, tnaqqis bħala “↓”, l-ebda bidla bħala “↔”).
English: Opaque blue and powder blue capsule printed with white and blue inks, with "BMS 150 mg" on one half and with "3624" on the other half.
Maltese: Kapsula opaka blu u blu ċar stampata b'inka bajda u blu, b'“BMS 150 mg” fuq nofs u bi “3624” fuq in-nofs l-ieħor.
English: REYATAZ oral powder should be given within 60 minutes of mixing.
Maltese: REYATAZ trab orali għandu jingħata fi żmien 60 minuta wara li tħalltu.
English: The mean half-life of atazanavir in hepatically impaired subjects was 12.1 hours compared to 6.4 hours in healthy subjects.
Maltese: Il-half-life medja ta' atazanavir f'individwi b'indeboliment talfunzjoni epatika kienet ta' 12.1 sigħat meta mqabbla ma' 6.4 sigħat f'individwi b'saħħithom.
English: In HIV-infected patients (n=13), multiple dosing of REYATAZ 400 mg (without ritonavir) once daily with food produced a geometric mean (CV%) for atazanavir Cmax of 2298 (71) ng/ml, with time to Cmax of approximately 2.0 hours.
Maltese: F'pazjenti infettati bl-HIV (n=13), l-għoti ta' dożi multipli ta' REYATAZ 400 mg (mingħajr ritonavir) darba kuljum mal-ikel wassal għal medja ġeometrika (CV %) għas-Cmax ta' atazanavir ta' 2,298 (71) ng/ml, b'ħin ta' madwar sagħtejn għas-Cmax.
English: Study 045 is a randomised, multicenter trial comparing REYATAZ/ritonavir (300/100 mg once daily) and REYATAZ/saquinavir (400/1,200 mg once daily), to lopinavir + ritonavir (400/100 mg fixed dose combination twice daily), each in combination with tenofovir disoproxil fumarate (see sections 4.5 and 4.8) and one NRTI, in patients with virologic failure on two or more prior regimens containing at least one PI, NRTI, and NNRTI.
Maltese: Studju 045 huwa prova b'aktar minn ċentru wieħed, randomizzat li tqabbel REYATAZ/ritonavir (300/100 mg darba kuljum) u REYATAZ/saquinavir (400/1,200 mg darba kuljum), għal lopinavir + ritonavir (400/100 mg kombinazzjoni ta' doża fissa darbtejn kuljum), kull waħda f'kombinazzjoni ma' tenofovir disoproxil fumarate (ara sezzjonijiet 4.5 and 4.8) u NRTI wieħed, f'pazjenti b'indeboliment viroloġiku fuq żewġ korsijiet bażiċi jew aktar li fihom għallinqas PI, NRTI, u NNRTI wieħed.
English: Treatment-Naive REYATAZ Powder/ritonavir n=52
Maltese: Pazjenti li Kienu Kkurati filPassat bi Trab ta' REYATAZ/ritonavir n=82
English: asthenia (unusual tiredness or weakness) weight decreased, weight gain, anorexia (loss of appetite), appetite increased depression, anxiety, sleep disorder disorientation, amnesia (loss of memory), dizziness, somnolence (sleepiness), abnormal dream syncope (fainting), hypertension (high blood pressure) dyspnoea (shortness of breath) pancreatitis (inflammation of the pancreas), gastritis (inflammation of the stomach), stomatitis aphthous (mouth ulcers and cold sores), dysgeusia (impairment of the sense of taste), flatulence (wind), dry mouth, abdominal distension angioedema (severe swelling of the skin and other tissues most often the lips or the eyes) alopecia (unusual hair loss or thinning), pruritus (itching) muscle atrophy (muscle shrinkage), arthralgia (joint pain), myalgia (aching muscles) interstitial nephritis (kidney inflammation), haematuria (blood in the urine), proteinuria (excess protein in the urine), pollakiuria (increased frequency of urination) gynaecomastia (breast enlargement in men) chest pain, malaise (generally feeling unwell), fever insomnia (difficulty sleeping)
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100): newropatija periferali (truxija, dgħjufija, tagħrix jew uġigħ fid-dirgħajn u fis-saqajn) sensittività eċċessiva (reazzjoni allerġika) astenja (għeja jew dgħjufija mhux normali) tnaqqis fil-piż, żieda fil-piż, anoreksja (telf ta' l-aptit), żieda fl-aptit dipressjoni, ansjetа, disturbi fl-irqad disorjentazzjoni, amnesija (telf ta' memorja), sturdament, ngħas (ħelda), ħolm mhux normali sinkope (ħass ħażin), ipertensjoni (pressjoni tad-demm għolja) dispnea (qtugħ ta' nifs) pankreatite (infjammazzjoni tal-pancreas), gastrite (infjammazzjoni ta' l-istonku), stomatitis aphtous (ulċeri tal-ħalq u ponot tad-deni), disgwezja (indeboliment tas-sens tat-togħma), gass, ħalq xott, distensjoni addominali anġjoedema (nefħa severa tal-ġilda u tessut ieħor, l-iktar ta' spiss tax-xufftejn jew tal-għajnejn) alopeċja (waqa' tax-xagħar mhux normali jew tħaffif tax-xagħar), prurite (ħakk) muskolotrofija (tnaqqis fil-volum tal-muskoli), artralġja (uġigħ fil-ġogi), mijalġja (uġigħ filmuskoli) nefrite interstizjali (infjammazzjoni tal-kliewi), ħematurja (demm fl-awrina), proteinurja (eċċess ta' proteina fl-awrina), pollakjurja (żieda fil-frekwenza ta' tibwil) ginektomastja (tkabbir tas-sider fl-irġiel) uġigħ fis-sider, malaise (kundizzjoni ġenerali ħażina), deni insomnja (diffikultà fl-irqad)
English: Stevens-Johnson syndrome (SJS), erythema multiforme, toxic skin eruptions and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been reported in patients receiving REYATAZ.
Maltese: Is-sindromu ta' Stevens-Johnson (SJS), eritema multiforme, eruzzjonijiet tossiċi tal-ġilda u s-sindromu ta' raxx dovut għall-mediċina b'esinofilja u sintomi sistemiċi (DRESS - drug rash with eosinophilia and systemic symptoms) ġew irrapportati f'pazjenti li kienu qegħdin jirċievu REYATAZ.
English: SEDATIVES Benzodiazepines
Maltese: Popolazzjoni dijabetika
English: Among patients receiving REYATAZ 300 mg with ritonavir 100 mg, the frequency of jaundice was 19%.
Maltese: Fost il-pazjenti li ħadu REYATAZ 300 mg ma' ritonavir 100 mg, il-frekwenza tas-suffejra kienet ta' 19 %.
English: REYATAZ 300 mg hard capsules
Maltese: REYATAZ 300 mg kapsuli ibsin
English: Table 8: Steady-State Pharmacokinetics of Atazanavir with ritonavir in HIV-Infected Pregnant Women in the Fed State atazanavir 300 mg with ritonavir 100 mg Pharmacokinetic Parameter 2nd Trimester (n=9)
Maltese: Tabella 8: Farmakokinetika fl-Istat Fiss ta' Atazanavir ma' ritonavir f'Nisa Tqal Infettati blHIV fi Stat Mhux Sajjem atazanavir 300 mg ma' ritonavir 100 mg
English: TreatmentExperienced REYATAZ Capsules/ritonavir (300 mg/100 mg once daily) n=25
Maltese: Pazjenti li Kienu Kkurati fil-Passat b'kapsuli REYATAZ/ritonavir (300 mg/100 mg darba kuljum) n=25
English: Co-administration of REYATAZ with ritonavir and medicinal products that induce CYP3A4 is not recommended (see sections 4.3 and 4.5).
Maltese: L-użu ta' REYATAZ u mediċinali oħra li jistimulaw CYP3A4 mhux irrikmandat (ara sezzjonijiet 4.3 u 4.5).
English: Fluconazole 200 mg once daily (atazanavir 300 mg and ritonavir 100 mg once daily)
Maltese: Fluconazole 200 mg darba kuljum (atazanavir 300 mg u ritonavir 100 mg darba kuljum)
English: H2-Receptor antagonists
Maltese: Antagonisti tar-Riċettur H2
English: REYATAZ 100 mg hard capsules
Maltese: REYATAZ 100 mg kapsuli ibsin
English: REYATAZ/ritonavir with a proton pump inhibitor is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of REYATAZ to 400 mg with 100 mg of ritonavir; doses of proton pump inhibitors comparable to omeprazole 20 mg should not be exceeded (see section 4.4).
Maltese: Jekk ilkombinazzjoni ta' REYATAZ/ritonavir ma' inibitur tal-proton pump titqies inevitabbli, huwa rakkomandat monitoraġġ kliniku mill-qrib f'kombinazzjoni ma' żieda fiddoża ta' REYATAZ għal 400 mg ma' 100 mg ta' ritonavir; dożi ta' inibituri talproton pump komparabbli ma' omeprazole 20 mg m'għandhomx jinqabżu (ara sezzjoni 4.4).
English: Atazanavir (am): 2 hr after omeprazole Atazanavir AUC ↓61% (↓65% ↓55%) Atazanavir Cmax ↓66% (↓62% ↓49%) Atazanavir Cmin ↓65% (↓71% ↓59%)
Maltese: AUC ta' Atazanavir ↓61% (↓65% Cmax ta' Atazanavir ↓66% (↓62% Cmin ta' Atazanavir ↓65% (↓71%
English: Quinidine has a narrow therapeutic window and is contraindicated due to potential inhibition of CYP3A by REYATAZ/ritonavir.
Maltese: Quinidine għandu perjodu terapewtiku dejjaq u huwa kontraindikat minħabba linibizzjoni potenzjali ta' CYP3A minn REYATAZ/ritonavir.
English: Rifabutin AUC ↑48% (↑19% ↑84%) Rifabutin Cmax ↑149% (↑103% ↑206%) Rifabutin Cmin ↑40% (↑5% ↑87%) ** 25-O-desacetyl-rifabutin AUC ↑990% 25-O-desacetyl-rifabutin Cmax ↑677% 25-O-desacetyl-rifabutin Cmin ↑1045%
Maltese: AUC ta' Rifabutin ↑48 % (↑19 % Cmax ta' Rifabutin ↑149 % (↑103 % Cmin ta' Rifabutin ↑40 % (↑5 % ↑87 %)
English: Ritonavir 100 mg once daily (atazanavir 300 mg once daily)
Maltese: Ritonavir 100 mg darba kuljum (atazanavir 300 mg darba kuljum)
English: REYATAZ 200 mg hard capsules are also supplied in blister strips in packs of 60 capsules.
Maltese: REYATAZ 200 mg kapsuli ibsin jiġu f'folji f'pakketti ta' 60 kapsuli.
English: For treatment-naive paediatric patients, the mean baseline CD4 cell count was 930 cells/mm3 (range: 46 to 2291 cells/mm3) and mean baseline plasma HIV-1 RNA was 4.81 log10 copies/ml (range: 3.4 to 5.9 log10 copies/ml).
Maltese: Għal pazjenti pedjatriċi li qatt ma kienu kkurati fil-passat, l-għadd medju ta' ċelloli CD 4 fil-linja bażi kien ta' 930 ċellola/mm3 (medda: bejn 46 u 2,291 ċellola/mm3) u u l-linja bażi medja ta ' HIV-1 RNA fil-plażma kienet ta' 4.81 log10 kopja/ml (medda: bejn 3.4 u 5.9 log10 kopja/ml).
English: REYATAZ with ritonavir is contraindicated in patients with moderate hepatic insufficiency (see sections 4.2, 4.4 and 5.2).
Maltese: REYATAZ ma' ritonavir huwa kontraindikat f'pazjenti b'indeboliment epatiku moderat (ara sezzjonijiet 4.2, 4.4 u 5.2).
English: The mechanism of interaction is decreased solubility of atazanavir as intra-gastric pH increases with proton pump inhibitors.
Maltese: Ilmekkaniżmu ta' interazzjoni huwa solubilità mnaqqsa ta' atazanavir hekk kif il-pH intragastriku jiżdied b'inibituri tal-proton pump.
English: Both asymptomatic first-degree (23%) and second-degree (1%) atrioventricular block were reported in paediatric patients.
Maltese: Ġew irrappurtati kemm imblokk atrijoventrikulari tal-ewwel grad (23 %) u tat-tieni grad (1 %) f'pazjenti pedjatriċi.
English: REYATAZ 150 mg hard capsules atazanavir
Maltese: REYATAZ 150 mg kapsuli ibsin atazanavir
English: Co-administration of REYATAZ with proton pump inhibitors is not recommended (see section 4.5).
Maltese: Amministrazzjoni fl-istess ħin ta' REYATAZ ma' inibituri proton pump m'hijiex rakkomandata (ara sezzjoni 4.5).
English: Phenylketonuria
Maltese: Fenilketonurja
English: Particular caution should be used when prescribing REYATAZ in association with medicinal products which have the potential to increase the QT interval and/or in patients with pre-existing risk factors (bradycardia, long congenital QT, electrolyte imbalances (see sections 4.8 and 5.3).
Maltese: Għandha tingħata attenzjoni partikulari meta REYATAZ ikun preskritt flimkien ma' prodotti mediċinali li jistgħu jżidu l-intervall QT u/jew f'pazjenti li diġà għandhom fatturi ta' riskju (bradikardja, QT konġenitali twila, żbilanċi ta' elettroliti (ara sezzjonijiet 4.8 u 5.3).
English: Atazanavir AUC ↓19% (↓35% ↑2%) * Atazanavir Cmax ↔2% (↓15% ↑24%) * Atazanavir Cmin ↓59% (↓73% ↓40%) *
Maltese: AUC ta' Atazanavir ↓19 % (↓35 % Cmax ta' Atazanavir ↔2 % (↓15 % Cmin ta' Atazanavir ↓59 % (↓73 %
English: The REYATAZ/ritonavir arm showed similar (non-inferior) antiviral efficacy compared to the lopinavir/ritonavir arm, as assessed by the proportion of patients with HIV RNA < 50 copies/ml at week 48 (Table 5).
Maltese: Il-fergħa ta' REYATAZ/ritonavir auriet effikaċja antivirali simili (mhux inferjuri) meta mqabbla mal-fergħa ta' lopinavir/ritonavir, kif evalwat mill-proporzjon ta' pazjenti b'HIV RNA <50 kopji/ml f'ġimgħa 48 (Tabella 5).
English: REYATAZ capsules, co-administered with low dose ritonavir, are indicated for the treatment of HIV1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products (see section 4.2).
Maltese: Il-kapsuli REYATAZ, li jingħataw flimkien ma' doża baxxa ta' ritonavir, huma indikati bħala kura lil pazjenti adulti u pedjatriċi li għandhom 6 snin jew aktar infettati b'HIV-1 flimkien ma' prodotti mediċinali antiretrovirali oħra (ara sezzjoni 4.2).
English: ANTI-HCV AGENTS Grazoprevir 200 mg once daily (atazanavir 300 mg / ritonavir 100 mg once daily)
Maltese: SUSTANZI KONTRA L-HCV Grazoprevir 200 mg darba kuljum (atazanavir 300 mg / ritonavir 100 mg darba kuljum)
English: Proton pump inhibitors Omeprazole 40 mg once daily (atazanavir 400 mg once daily with ritonavir 100 mg once daily)
Maltese: Inibituri tal-proton pump Omeprazole 40 mg darba kuljum (atazanavir 400 mg darba kuljum ma' ritonavir 100 mg darba kuljum)
English: Table 5: Efficacy Outcomes in Study 138 a
Maltese: Riżultati ta' l-effikaċja fi Studju 138a
English: 80 mg b at least 35
Maltese: 80 mgb tal-inqas 35
English: 30 hard capsules: EU/1/03/267/008
Maltese: 30 kapsuli ibsin: EU/1/03/267/008
English: Four subjects in the unboosted REYATAZ group and 2 in the REYATAZ + ritonavir group had HIV RNA > 500 copies/ml during the maintenance phase.
Maltese: Erba' individwi fil-grupp ta' REYATAZ mhux imsaħħaħ u 2 fil-grupp ta' REYATAZ + ritonavir kellhom HIV RNA >500 kopja/ml matul il-fażi ta' manutenzjoni.
English: Concomitant use of REYATAZ/ritonavir and fluticasone or other glucocorticoids that are metabolised by CYP3A4 is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression (see section 4.5).
Maltese: L-użu flimkien ta' REYATAZ/ritonavir u fluticasone jew glucocorticoids oħra li huma metabolizzati b'CYP3A4 mhux rakkomandat sakemm il-benefiċċju mistenni ma jkunx akbar mir-riskju ta' l-effetti sistematiċi ta' corticosteroid, inkluż is-sindrome ta' Cushing u t-trażżin adrenali (ara sezzjoni 4.5).
English: Co-administration of REYATAZ with grazoprevir-containing products, including elbasvir/grazoprevir fixed dose combination is contraindicated because of the increase in grazoprevir and elbasvir plasma concentrations and potential for the increase in risk of ALT elevations associated with increased grazoprevir concentrations (see section 4.3).
Maltese: L-għoti flimkien ta' REYATAZ ma' prodotti li fihom grazoprevir, inkluż doża fissa kombinata ta' elbasvir/grazoprevir huwa kontraindikat minħabba ż-żieda fil-konċentrazzjonijiet fil-plażma ta' grazoprevir u elbasvir u l-potenzjal għaż-żieda fir-riskju ta' żidiet fl-ALT assoċjati ma' konċentrazzjonijiet miżjuda ta' grazoprevir (ara sezzjoni 4.3).
English: Consult the dosing table for the specific formulation (see Summary of Product Characteristics for REYATAZ capsules).
Maltese: Ikkonsulta t-tabella taddożaġġ għall-formulazzjonijiet speċifiċi (ara s-Sommarju tal-Karatteristiċi tal-Prodott għall-kapsuli ta' REYATAZ).
English: Atazanavir Cmin ↓19% (↓37% ↑5%) *
Maltese: Cmin ta' Ritonavir ↓19 % (↓35 % ↑1 %)
English: Bristol-Myers Squibb Kft.
Maltese: Bristol-Myers Squibb Kft. Teл.:
English: Omeprazole 20 mg once daily (atazanavir 400 mg once daily with ritonavir 100 mg once daily)
Maltese: Omeprazole 20 mg darba kuljum (atazanavir 400 mg darba kuljum ma' ritonavir 100 mg darba kuljum)
English: Each capsule contains 150 mg of atazanavir (as sulphate).
Maltese: Kull kapsula għandha 150 mg atazanavir (bħala sulphate).
English: For treatment experienced paediatric patients, the mean baseline CD4 cell count was 522 cells/mm3 (range: 100 to 1157 cells/ mm3) and mean baseline plasma HIV-1 RNA was 4.09 log10 copies/ml (range: 3.28 to 5.00 log10 copies/ml).
Maltese: Għal pazjenti pedjatriċi li kienu kkurati fil-passat, il-linja bażi medja tal-għadd ta' ċelluli CD4 kienet ta' 522 ċelluli/mm3 (medda: 100 sa 1,157 ċelluli/mm3) u livelli medji fil-linja bażi tal-HIV 1 RNA fil-plażma kienu ta' 4.09 log10 kopji/ml (firxa: 3.28 sa 5.00 log10 kopji/ml).
English: Efavirenz 600 mg once daily (atazanavir 400 mg once daily with ritonavir 200 mg once daily)
Maltese: Efavirenz 600 mg darba kuljum (atazanavir 400 mg darba kuljum ma' ritonavir 200 mg darba kuljum)
English: REYATAZ/ritonavir is coadministered with clarithromycin.
Maltese: REYATAZ/ritonavir u midazolam parenterali.
English: Opaque blue capsule printed with white ink, with "BMS 200 mg" on one half and with "3631" on the other half.
Maltese: Kapsula opaka blu stampata b'inka bajda, b'“BMS 200 mg” fuq nofs u b'“3631” fuq in-nofs l-ieħor.
English: In a clinical study AI424-020, paediatric patients 3 months to less than 18 years of age who received either the oral powder or capsule formulation had a mean duration of treatment with REYATAZ of 115 weeks.
Maltese: Fi studju kliniku AI424-020, pazjenti pedjatriċi minn 3 xhur sa mhux aktar minn 18-il sena li rċevew jew il-formulazzjoni fi trab orali jew kapsula kienu kkurati b'REYATAZ għal żmien medju ta' 115-il ġimgħa.
English: If the combination of REYATAZ with a proton pump inhibitor is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of REYATAZ to 400 mg with 100 mg of ritonavir; doses of proton pump inhibitors comparable to omeprazole 20 mg should not be exceeded.
Maltese: Jekk il-kombinazzjoni ta' REYATAZ ma' inibitur proton pump titqies bħala waħda inevitabbli, monitoraġġ kliniku mill-qrib huwa rakkomandat f'kombinazzjoni ma' żieda fid-doża ta' REYATAZ ta' 400 mg ma' 100 mg ta' ritonavir; id-dożi ta' inibituri proton pump komparabbli ma' omeprazole 20 mg ma għandhomx jinqabżu.
English: Bepridil
Maltese: Tqala
English: Co-administration with REYATAZ with ritonavir warrants clinical monitoring for sedation and cognitive effects.
Maltese: Huwa importanti li jiġu rrappurtati effetti sekondarji suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: The mechanism of interaction is CYP3A4 inhibition by atazanavir/ritonavir.
Maltese: Ilmekkaniżmu ta' interazzjoni huwa inibizzjoni ta' CYP3A4 minn atazanavir/ritonavir.
English: Adverse reactions were consistent between patients who received REYATAZ 400 mg once daily and patients who received REYATAZ 300 mg with ritonavir 100 mg once daily, except that jaundice and elevated total bilirubin levels were reported more frequently with REYATAZ plus ritonavir.
Maltese: Ir-reazzjonijiet avversi kienu konsistenti bejn pazjenti li ħadu REYATAZ 400 mg u pazjenti li ħadu REYATAZ 300 mg ma' ritonavir 100 mg darba kuljum, ħlief għas-suffejra u livelli għolja ta' bilirubin li ġew irrapportati aktar ta' spiss f'pazjenti li ħadu REYATAZ b'ritonavir.
English: For storage conditions after mixing of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara t-taħlit tal-prodott mediċinali, ara t-taqsima 6.3. 6.5
English: Rare (may affect up to 1 in 1,000 people): gait disturbance (abnormal manner of walking) oedema (swelling) hepatosplenomegaly (enlargement of the liver and spleen) myopathy (aching muscles, muscle tenderness of weakness, not caused by exercise) kidney pain
Maltese: Rari (jistgħu jaffettwaw sa persuna 1 minn kull 1,000): disturbi fil-qagħda (mod stramb ta' kif wieħed jimxi) edema (nefħa) ħepatosplenomegalija (tkabbir tal-fwied u tal-milsa) miopatija (uġigħ fil-muskoli, sensittivitа fil-muskoli kkawżata minn dgħjufija, mhux minn eżerċizzju) uġigħ fil-kliewi
English: The increase in progestin exposure may lead to related side-effects (e.g. insulin resistance, dyslipidemia, acne and spotting), thus possibly affecting the compliance.
Maltese: Iż-żieda fl-espożizzjoni ta' progestin tista' twassal għal effetti sekondarji relatati (eż. reżistenza għall-insulina, dislipidemija, akne u tikek fuq ilġilda), b'hekk possibbilment tista' taffettwa l-konformità.
English: Paediatric patients (at least 3 months of age and weighing at least 5 kg): REYATAZ oral powder is available for paediatric patients at least 3 months of age and weighing at least 5 kg (see Summary of Product Characteristics for REYATAZ oral powder).
Maltese: Pazjenti pedjatriċi (li għandhom tal-inqas 3 xhur u li jiżnu tal-inqas 5 kg): REYATAZ trab orali huwa disponibbli għal pazjenti pedjatriċi li għandhom tal-inqas 3 xhur u li jiżnu tal-inqas 5 kg (ara sSommarju tal-Karatterstiċi tal-Prodott għal REYATAZ trab orali).
English: NAME OF THE MEDICINAL PRODUCT REYATAZ 50 mg oral powder
Maltese: REYATAZ 50 mg trab orali
English: Didanosine (enteric coated capsules) 400 mg single dose (atazanavir 300 mg once daily with ritonavir 100 mg once daily)
Maltese: Didanosine (kapsuli miksijin b'mod enteriku) 400 mg doża waħda (atazanavir 300 mg darba kuljum ma' ritonavir 100 mg darba kuljum)
English: The combination of rifampicin and REYATAZ with concomitant low-dose ritonavir is contraindicated (see section 4.3).
Maltese: Il-kombinazzjoni ta' rifampicin u REYATAZ ma' ritonavir f'doża baxxa konkomitanti hija kontraindikata (ara sezzjoni 4.3).
English: REYATAZ 100 mg hard capsules are also supplied in blister strips in packs of 60 capsules.
Maltese: REYATAZ 100 mg kapsuli ibsin jiġu f'folji f'pakketti ta' 60 kapsuli.
English: REYATAZ 200 mg hard capsules
Maltese: REYATAZ 200 mg kapsuli ibsin
English: ANTIMYCOBACTERIAL Rifabutin 150 mg twice weekly (atazanavir 300 mg and ritonavir 100 mg once daily)
Maltese: ANTIMIKOBATTERIĊI Rifabutin 150 mg darbtejn filġimgħa (atazanavir 300 mg u ritonavir 100 mg darba kuljum)
English: Also see PULMONARY ATERIAL HYPERTENSION in this table for further information regarding co-administration of REYATAZ/ritonavir with sildenafil.
Maltese: Ara wkoll PRESSJONI GĦOLJA ARTERJALI PULMONARI f'din it-tabella għal aktar informazzjoni dwar lgħoti fl-istess ħin ta' REYATAZ/ritonavir u sildenafil.
English: The capsule shell and printing ink contain gelatine, shellac, ammonium hydroxide, simethicone, red iron oxide, black iron oxide, yellow iron oxide, propylene glycol, indigocarmin (E132) and titanium dioxide (E171).
Maltese: Il-qoxra talkapsula u l-linka fihom gelatine, shellac, ammonium hydroxide, simethicone, propylene glycol, indigocarmin (E132) u titanium dioxide (E171).
English: Gallbladder problems uncommonly happen in people taking REYATAZ.
Maltese: Problemi fil-marrara jseħħu b'mod mhux komuni f'persuni li jieħdu REYATAZ.
English: REYATAZ Dose once daily (mg)
Maltese: REYATAZ Doża darba kuljum (mg)
English: Paediatric trials with REYATAZ capsules
Maltese: Provi pedjatriċi b'kapsuli ta' REYATAZ
English: Patients should be closely monitored for tenofovir disoproxil-associated adverse reactions, including renal disorders.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati mill-qrib għal reazzjonijiet avversi assoċjati ma' tenofovir, inkluż disturbi renali.
English: Pregnancy:
Maltese: Tqala:
English: There were fewer treatment discontinuations in the unboosted REYATAZ group (1 vs. 4 subjects in the REYATAZ + ritonavir group).
Maltese: Kien hemm anqas twaqqif tal-kura fil-grupp ta' REYATAZ mhux imsaħħaħ (1 kontra 4 individwi filgrupp ta' REYATAZ + ritonavir).
English: Boceprevir 800 mg three times daily (atazanavir 300 mg/ritonavir 100 mg once daily)
Maltese: Boceprevir 800 mg tliet darbiet kuljum (atazanavir 300 mg/ritonavir 100 mg darba kuljum)
English: 30 hard capsules: EU/1/03/267/009
Maltese: 30 kapsuli ibsin: EU/1/03/267/009
English: The pharmacokinetic data from HIV-infected pregnant women receiving REYATAZ capsules with ritonavir are presented in Table 8.
Maltese: It-tagħrif farmakokinetiku minn nisa tqal infettati bl-HIV li kienu qegħdin jirċievu kapsuli ta' REYATAZ ma' ritonavir huwa ppreżentat fit-Tabella 8.
English: Ketoconazole and itraconazole should be used cautiously with REYATAZ/ritonavir.
Maltese: Ketoconazole u itraconazole għandhom jintużaw b'kawtela ma' REYATAZ/ritonavir.