FrancophonIA/ELRC3.0 huggingface dataset:
English: The mechanism of interaction is decreased solubility of atazanavir as intra-gastric pH increases with H2- blockers.
Maltese: Il-mekkaniżmu ta' interazzjoni huwa tnaqqis fis-solubilità ta' atazanavir hekk kif il-pH intragastriku jiżdied bl imblokkaturi ta' H2.
English: Treatment of overdose with Atazanavir Krka 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' Atazanavir Krka 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: Atazanavir AUC ↓12% (↓18% Atazanavir cmax ↓13% (↓20% Atazanavir cmin ↓ 20 % (↓28%
Maltese: AUC ta' Atazanavir ↓12% (↓18% cmax ta' Atazanavir ↓13% (↓20% ↓4%) cmin ta' Atazanavir ↓20 % (↓28 %
English: Atazanavir AUC ↔0% (↓9% Atazanavir cmax ↑17% (↑8% Atazanavir cmin ↓42% (↓51%
Maltese: cmax ta' Atazanavir ↑17 % (↑8 % cmin ta' Atazanavir ↓42 % (↓51 %
English: Capsule shell of Atazanavir Krka 200 mg hard capsules Body: titanium dioxide (E171) yellow ferric oxide (E172) red ferric oxide (E172) gelatine
Maltese: Krka 200 mg kapsuli ibsin Korp: titanium dioxide (E171) yellow ferric oxide (E172) red ferric oxide (E172) gelatine
English: Elbasvir 50 mg once daily (atazanavir 300 mg/ ritonavir 100 mg once daily)
Maltese: Elbasvir 50 mg darba kuljum (atazanavir 300 mg / ritonavir 100 mg darba kuljum)
English: PHARMACEUTICAL FORM AND CONTENTS Hard capsule
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT
English: Atazanavir Krka once daily dose ritonavir once daily dosea
Maltese: Atazanavir Krka Doża darba kuljum doża ta' ritonavir darba kuljum a minn 15 sa inqas minn 35
English: All patients HIV RNA <400 copies/ml, %
Maltese: HIV RNA <400 kopji/ml, % a
English: Three of 20 infants (15%) born to women treated with atazanavir /ritonavir 300/100 mg and four of 20 infants (20%) born to women treated with atazanavir /ritonavir 400/100 mg experienced grade 3-4 bilirubin.
Maltese: Tlieta mill-20 tarbija (15 %) imwielda minn nisa kkurati b'atazanavir/ritonavir 300/100 mg u erbgħa minn 20 tarbija (20 %) twieldu lil nisa kkurati b'atazanavir/ritonavir 400/100 mg esperjenzaw bilirubin ta' skala 3-4.
English: Ritonavir may decrease plasma levels of phenytoin and/or phenobarbital due to CYP2C9 and CYP2C19 induction.
Maltese: Ritonavir jista' jnaqqas il-livelli ta' phenytoin u/jew ta' phenobarbital minħabba induzzjoni ta' CYP2C9 u ta'
English: If the combination of Atazanavir Krka with a proton pump inhibitor is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of Atazanavir Krka to 400 mg with 100 mg of ritonavir; doses of proton pump inhibitors comparable to omeprazole 20 mg should not be exceeded.
Maltese: Krka ma' inibitur proton pump titqies bħala waħda inevitabbli, monitoraġġ kliniku mill-qrib huwa rakkomandat f'kombinazzjoni ma' żieda fid doża ta' Atazanavir Krka ta' 400 mg ma' 100 mg ta' ritonavir; id-dożi ta' inibituri proton pump komparabbli ma' omeprazole 20 mg ma għandhomx jinqabżu.
English: Atazanavir AUC ↔6% (↓10%
Maltese: ritonavir AUC ↓ 36%
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 atazanavir 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
English: Through 48 weeks of treatment, the mean changes from baseline in HIV RNA levels for atazanavir + ritonavir and lopinavir + ritonavir were similar (non-inferior).
Maltese: HIV RNA għal atazanavir+ ritonavir u lopinavir + ritonavir kienu l-simili (mhux inferjuri).
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)
English: Co-administration of simvastatin or lovastatin with atazanavir is contraindicated due to an increased risk of myopathy including rhabdomyolysis (see section 4.3).
Maltese: L-għoti flimkien ta' simvastatin jew lovastatin ma' atazanavir hu kontraindikat minħabba riskju miżjud ta' mijopatija inkluż rabdomijoliżi (ara sezzjoni 4.3).
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: HIV RNA Mean Change from Baseline, log10 copies/ml
Maltese: Bidla Medja fl-HIV RNA mil-Linja Bażi, log10 kopji/ml
English: * In a combined analysis from several clinical studies, atazanavir/ritonavir 300/100 mg co-administered with tenofovir disoproxil fumarate 300 mg (n=39) was compared to atazanavir/ritonavir 300/100 mg (n=33).
Maltese: tenofovir disoproxil fumarate 300 mg (n=39) tqabbel ma' atazanavir/ritonavir 300/100 mg (n=33).
English: Atazanavir inhibits UGT and may interfere with the metabolism of irinotecan, resulting in increased irinotecan toxicities.
Maltese: irinotecan, li jirriżulta f'effetti tossiċi miżjuda ta' irinotecan.
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 tal funzjoni epatika kienet ta' 12.1 sigħat meta mqabbla ma' 6.4 sigħat f'individwi b'saħħithom.
English: common: vomiting, diarrhoea, abdominal pain, nausea, dyspepsia; uncommon: pancreatitis, gastritis, abdominal distension, stomatitis aphthous, flatulence, dry mouth
Maltese: dispepsja; mhux komuni: pankreatite, gastrite, distensjoni addominali, stomatite aphthous, gass fl-istonku, ħalq xott
English: Capsule shell of Atazanavir Krka 150 mg hard capsules Body: titanium dioxide (E171) gelatine
Maltese: Krka 150 mg kapsuli ibsin Korp: titanium dioxide (E171) gelatine
English: 100 to <200 cells/mm
Maltese: 100 sa <200
English: Metabolism and nutrition disorders uncommon: weight decreased, weight gain, anorexia, appetite increased
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni: mhux komuni: tnaqqis fil-piż, żieda fil-piż, anoreksja,
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 %
English: Famotidine 20 mg twice daily Atazanavir AUC ↓18% (↓25% Atazanavir cmax ↓20% (↓32% Atazanavir cmin ↔1% (↓16% Famotidine 40 mg twice daily Atazanavir AUC ↓23% (↓32% Atazanavir cmax ↓23% (↓33% Atazanavir cmin ↓20% (↓31% ↓8%) In Healthy volunteers with atazanavir/ritonavir at an increased dose of 400/100 mg once daily Famotidine 40 mg twice daily Atazanavir AUC ↔3% (↓14% Atazanavir cmax ↔2% (↓13% Atazanavir cmin ↓14% (↓32% ↑8%) With Tenofovir disoproxil fumarate 300 mg once daily (equivalent to 245 mg tenofovir disoproxil) In HIV-infected patients with atazanavir/ritonavir at the recommended dose of 300/100 mg once daily
Maltese: AUC ta' Atazanavir ↓23% (↓32% cmax ta' Atazanavir ↓23% (↓33% cmin ta' Atazanavir ↓20% (↓31% ↓8%) F'voluntiera b'saħħithom b'atazanavir/ritonavir b'doża miżjuda ta' 400/100 mg darba kuljum Famotidine 40 mg darbtejn kuljum
English: uncommon: hypertension
Maltese: mhux komuni: dispneja
English: b ATV/RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily).
Maltese: b ATV/RTV b'tenofvir disoproxil fumarate/emtricitabine (doża fissa ta' pilloli 300 mg/200 mg darba kuljum).
English: Among patients who received atazanavir 400 mg once daily or atazanavir 300 mg with ritonavir 100 mg once daily, the only adverse reactions of any severity reported very commonly with at least a possible relationship to regimens containing atazanavir and one or more NRTIs were nausea (20%), diarrhoea (10%), and jaundice (13%).
Maltese: Fost il-pazjenti li ħadu atazanavir 400 mg darba kuljum jew atazanavir 300 mg ma' ritonavir 100 mg darba kuljum, l-uniċi reazzjonijiet avversi ta' xi severità li ġew irrappurtati b'mod komuni ħafna li għall-inqas kien possibbli li kellhom x'jaqsmu mat-terapija li kienet tinkludi atazanavir u wieħed jew iktar NRTIs kienu nawsja (20 %), dijarrea (10 %) u suffejra (13 %).
English: How to take Atazanavir Krka
Maltese: Kif taħżen Atazanavir Krka
English: Uncommon (may affect up to 1 in 100 people): - peripheral neuropathy (numbness, weakness, tingling or pain in the arms and legs) - hypersensitivity (allergic reaction) - 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,
Maltese: - 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)
English: Hard gelatine capsule, size no. 1.
Maltese: Kapsula tal-ġelatina iebsa, ta' daqs nru, 1.
English: Consult the dosing table for the specific formulation (see Summary of Product Characteristics for other formulations).
Maltese: Ikkonsulta t-tabella taddożaġġ għall-formulazzjoni speċifika (ara s-Sommarju tal-Karatteristiċi tal-Prodott għal formulazzjonijiet oħra).
English: Treatment- Experienced atazanavir Capsules/ritonavir (300 mg/100 mg once daily) n=25
Maltese: Pazjenti li Kienu Kkurati fil-Passat b'kapsuli atazanavir/ritonavir (300 mg/100 mg darba kuljum) n=25
English: (400 mg/ 100 mg twice daily (n=123)
Maltese: LPV/RTVc (400 mg/ 100 mg darbtejn kuljum) (n=123)
English: Atazanavir Krka 200 mg hard capsules Each hard capsule contains 200 mg atazanavir (as sulphate).
Maltese: Krka 200 mg kapsuli ibsin Kull kapsula iebsa fiha 200 mg atazanavir (bħala sulfat).
English: The efficacy of atazanavir /ritonavir in combination with
Maltese: atazanavir/ritonavir.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1353/001
Maltese: EU/1/19/1353/001
English: Cap: titanium dioxide (E171) yellow ferric oxide (E172) red ferric oxide (E172) gelatine ink:
Maltese: titanium dioxide (E171) yellow ferric oxide (E172) red ferric oxide (E172) gelatine linka:
English: The mechanism of this decrease is unknown (see sections 4.2 and 4.4.
Maltese: Il-mekkaniżmu ta' dan it-tnaqqis mhuwiex magħruf (ara sezzjonijiet 4.2 u 4.4).
English: uncommon: nephrolithiasis a, haematuria, proteinuria, pollakiuria, interstitial nephritis; chronic kidney diseasea rare: kidney pain
Maltese: Disturbi fil-kliewi u fis-sistema urinarja: mhux komuni: nefrolitjażia, ematurja, proteinurja, pollakurja; nefrite interstizjali, mard tal-kliewi kronikua;
English: Co-administration of nevirapine and atazanavir is not recommended (see section 4.4)
Maltese: nevirapine u atazanavir mhuwiex rakkomandat (ara sezzjoni 4.4)
English: Rifampicin is a strong CYP3A4 inducer and has been shown to cause a 72% decrease in atazanavir AUC which can result in virological failure and resistance development.
Maltese: CYP3A4 u ntwera li jikkawża tnaqqis ta' 72 % fl-AUC ta' atazanavir li jista'
English: c Lopinavir/RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily).
Maltese: c Lopinavir/RTV ma' tenofovir/disoproxil fumarate/emtricitabine (pilloli ta' doża fissa ta' 300 mg/200 mg darba kuljum).
English: c LPV/RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily).
Maltese: c LPV/RTV b'tenofvir disoproxil fumarate/emtricitabine (doża fissa ta' pilloli ta' 300 mg/200 mg darba kuljum).
English: Four subjects in the unboosted atazanavir group and 2 in the atazanavir + ritonavir group had HIV RNA > 500 copies/ml during the maintenance phase.
Maltese: Erba' individwi fil-grupp ta' atazanavir mhux imsaħħaħ u 2 fil-grupp ta' atazanavir+ ritonavir kellhom HIV RNA >500 kopja/ml matul il-fażi ta'
English: Efficacy Outcomes in Study 138a atazanavir /ritonavirb (300 mg/100 mg once daily) n=440
Maltese: Parametru atazanavir/ritonavirb (300 mg/100 mg darba kuljum) n=440
English: Cap: titanium dioxide (E171) yellow ferric oxide (E172) red ferric oxide (E172) black ferric oxide (E172) gelatine ink:
Maltese: titanium dioxide (E171) yellow ferric oxide (E172) red ferric oxide (E172) black ferric oxide (E172) gelatine linka:
English: Atazanavir Krka is contraindicated in patients with severe hepatic insufficiency (see sections 4.2, 4.4 and 5.2).
Maltese: Krka huwa kontraindikat f'pazjenti b'indeboliment epatiku sever (ara sezzjonijiet 4.2, 4.4 u 5.2).
English: For treatment-naive paediatric patients, the mean baseline CD4 cell count was 344 cells/mm3 (range: 2 to 800 cells/ mm3) and mean baseline plasma HIV-1 RNA was 4.67 log10 copies/ml (range: 3.70 to 5.00 log10 copies/ml).
Maltese: L-għadd taċ-ċelluli CD4 tal-medja tal-linja bażi kien 337 ċellula/mm3 (firxa: minn 14 sa 1,543 ċellula/mm3) u l-livell medju tal-linja bażi tal-plażma HIV-1 RNA kien 4.4 log10 kopji/ml (firxa minn 2.6 sa 5.88 log10 kopji/ml).
English: Cap: titanium dioxide (E171), yellow ferric oxide (E172), red ferric oxide (E172), black ferric oxide (E172), gelatine and ink (shellac, titanium dioxide (E171), potassium hydroxide
Maltese: Għatu: titanium dioxide (E171), yellow ferric oxide (E172), red ferric oxide (E172), black ferric oxide (E172), gelatine u linka (shellac, titanium oxide (E171), potassium hydroxide)
English: common: headache; uncommon: peripheral neuropathy, syncope, amnesia, dizziness, somnolence, dysgeusia
Maltese: mhux komuni: newropatija periferali, sinkope, amnesija,
English: Cap: titanium dioxide (E171), yellow ferric oxide (E172), red ferric oxide (E172), gelatine and ink (shellac, black ferric oxide (E172), potassium hydroxide
Maltese: Għatu: titanium dioxide (E171), yellow ferric oxide (E172), red ferric oxide (E172), gelatine u linka (shellac, black ferric oxide (E172), potassium hydroxide)
English: Each hard capsule contains 105.91 mg lactose monohydrate.
Maltese: 91 mg lactose monohydrate.
English: The M184V substitution in reverse transcriptase, which confers resistance to lamivudine and emtricitabine, was detected in 2 subjects in the unboosted atazanavir and 1 subject in the atazanavir + ritonavir group.
Maltese: Is-sostituzzjoni M184V f'reverse transcriptase, li tagħti reżistenza lil lamivudine u lil emtricitabine, instabet f'żewġ individwi fil-grupp ta' atazanavir mhux imsaħħaħ u f'individwu wieħed fil-grupp ta' atazanavir+ ritonavir.
English: An alternate reliable method of contraception is recommended.
Maltese: Huwa rakkomandat metodu alternattiv affidabbli ta'
English: Atazanavir Krka 150 mg hard capsules
Maltese: Krka 150 mg kapsuli ibsin
English: Studies conducted in HIV- infected patients.
Maltese: Studji mwettqa fuq pazjenti infettati bl-HIV.
English: Co-administration of atazanavir with glecaprevir/pibrentasvir fixed dose combination is contraindicated because of the potential increase in the risk of ALT elevations due to a significant increase in glecaprevir and pibrentasvir plasma concentrations (see section 4.3).
Maltese: L-għoti flimkien ta' atazanavir ma' doża fissa kombinata ta' glecaprevir/pibrentasvir huwa kontraindikat minħabba ż-żieda potenzjali fir-riskju ta' żidiet fl-ALT minħabba żieda sinifikanti fil-konċentrazzjonijiet fil-plażma ta' glecaprevir u pibrentasvir (ara sezzjoni 4.3).
English: The mechanism of interaction is a reduced solubility of atazanavir with increasing pH related to the presence of anti-acid agent in didanosine buffered tablets.
Maltese: interazzjoni huwa solubilità mnaqqsa ta' atazanavir hekk kif tiżdied il-pH relatata mal-preżenza ta' sustanza kontra l-aċidi fil-pilloli buffered ta' didanosine.
English: Adverse reactions were consistent between patients who received atazanavir 400 mg once daily and patients who received atazanavir 300 mg with ritonavir 100 mg once daily, except that jaundice and elevated total bilirubin levels were reported more frequently with atazanavir plus ritonavir.
Maltese: Ir-reazzjonijiet avversi kienu konsistenti bejn pazjenti li ħadu atazanavir 400 mg u pazjenti li ħadu atazanavir 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 atazanavir b'ritonavir.
English: * When compared to atazanavir 300 mg and ritonavir 100 mg without nevirapine.
Maltese: * Meta mqabbel ma' ctazanavir 300 mg u ritonavir 100 mg mingħajr nevirapine.
English: diltiazem, systemic lidocaine, verapamil) - atorvastatin, pravastatin, and fluvastatin (used to lower blood cholesterol) - salmeterol (used to treat asthma) - cyclosporin, tacrolimus, and sirolimus (medicines to decrease the effects of body's immune system) - certain antibiotics (rifabutin, clarithromycin) - ketoconazole, itraconazole, and voriconazole (antifungals) - warfarin (anticoagulant, used to reduce the blood clots) - carbamazepine, phenytoin, phenobarbital, lamotrigine (antiepileptics) - irinotecan (used to treat cancer) - sedative agents (e.g. midazolam administered by injection) - buprenorphine (used to treat opioid addiction and pain).
Maltese: - salmeterol (użat għall-kura tal-ażżma) - cyclosporine, tacrolimus, u sirolimus (mediċini biex inaqqsu l-effetti tas-sistema ta' l-immunità tal-ġisem) - xi antibijotiċi (rifabutin, clarithromycin)
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu
English: , vesiculobullous rash, eczema,
Maltese: sturdament, ħedla, disgwesja
English: Atazanavir Krka 150 mg hard capsules Each hard capsule contains 150 mg atazanavir (as sulphate).
Maltese: Krka 150 mg kapsuli ibsin Kull kapsula iebsa fiha 150 mg atazanavir (bħala sulfat).
English: Capsule shell of Atazanavir Krka 300 mg hard capsules Body: titanium dioxide (E171) gelatine
Maltese: Qoxra tal-kapsula ta' Atazanavir Krka 300 mg kapsuli ibsin Korp: titanium dioxide (E171) gelatin
English: Therefore, Atazanavir Krka is contraindicated with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index: quetiapine, lurasidone, alfuzosin, astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, triazolam, orally administered midazolam, and ergot alkaloids, particularly ergotamine and dihydroergotamine (see section 4.3).
Maltese: Għalhekk, Atazanavir Krka huwa kontra-indikat ma' prodotti mediċinali li huma sottosratti ta' CYP3A4 u li għandhom indiċi terapewtiku limitat: quetiapine, lurasidone, alfuzosin, astemizole, terfenadine,
English: Osteonecrosis
Maltese: ANTIBIJOTIĊI
English: Respiratory, thoracic and meadiastinal disorders uncommon: dyspnoea
Maltese: Disturbi respiratorji, toraċiċi u medjastinali:
English: Ketoconazole and itraconazole should be used cautiously with atazanavir /ritonavir, high doses of ketoconazole and itraconazole (>200 mg/day) are not recommended.
Maltese: għoljin ta' ketoconazole u itraconazole (>200 mg/kuljum).
English: - in patients with at least one functional CYP2C19 allele, close clinical monitoring for a loss of both voriconazole (clinical signs) and atazanavir (virologic response) efficacy is recommended.
Maltese: CYP2C19 wieħed, monitoraġġ kliniku mill-qrib għat-telf tal effikaċja kemm ta' voriconazole (sinjali kliniċi) u atazanavir (rispons viroloġiku) hu rakkomandat.
English: Subjects with at least one functional CYP2C19 allele.
Maltese: CYP2C19 funzjonali wieħed.
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 atazanavir 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'atazanavir għal żmien medju ta' 115-il ġimgħa.
English: HCV Protease Inhibitors 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: Co-administration with grazoprevir-containing products, including elbasvir/grazoprevir fixed dose combination (see section 4.5).
Maltese: elbasvir/grazoprevir (ara sezzjoni 4.5).
English: The mechanism of interaction is CYP3A4 and UGT1A1 inhibition.
Maltese: Il-mekkaniżmu ta' interazzjoni huwa l inibizzjoni ta' CYP3A4 u UGT1A1.
English: Among patients receiving atazanavir 300 mg with ritonavir 100 mg, the frequency of jaundice was 19%.
Maltese: Fost il-pazjenti li ħadu atazanavir 300 mg ma' ritonavir 100 mg, il-frekwenza tas-suffejra kienet ta' 19 %.
English: Patients should be warned about these possible side effects when using PDE5 inhibitors for erectile dysfunction with atazanavir (see section 4.4).
Maltese: Il-pazjenti għandhom jiġu mwissija dwar dawn l-effetti sekondarji li jista' jkun hemm meta jintużaw inibituri PDE5 għal disfunzjoni erettili b'atazanavir (ara sezzjoni 4.4).
English: The recommended adult dose of Atazanavir Krka capsules is 300 mg once daily with 100 mg ritonavir once daily and with food, in combination with other anti-HIV medicines.
Maltese: Id-doża rakkomandata għall-adulti tal-kapsuli ta' Atazanavir Krka hija normalment ta' 300 mg darba kuljum ma' 100 mg ritonavir darba kuljum u mal-ikel, flimkien ma' mediċini oħra ta' kontra l-HIV.
English: NAME OF THE MEDICINAL PRODUCT Atazanavir Krka 200 mg hard capsules atazanavir
Maltese: Krka 200 mg kapsuli ibsin atazanavir
English: The withdrawal of ritonavir from the boosted regimen of Atazanavir Krka is not recommended, but may be considered in adults patients at the dose of 400 mg once daily with food only under the following combined restrictive conditions: - absence of prior virologic failure - undetectable viral load during the last 6 months under current regimen - viral strains not harbouring HIV resistance associated mutations (RAMs) to current regimen.
Maltese: L-irtirar ta' ritonavir mill-iskeda msaħħa ta' Atazanavir Krka mhuwiex rakkomandat, iżda jista' jiġi kkunsidrat f'pazjenti adulti fid-doża ta' 400 mg darba kuljum mal-ikel u biss taħt il-kundizzjonijiet restrittivi kombinati li ġejjin: - nuqqas ta' falliment viroloġiku preċedenti - tagħbija virali mhux rilevabbli matul is-6 xhur ta' qabel taħt l-iskeda attwali - razez virali li ma jkunux qed iġorru mutazzjonijiet assoċjati ta' reżistenza għall-HIV (RAMs)
English: Reduced plasma concentrations of atazanavir may be the consequence of increased gastric pH if antacids, including buffered medicinal products, are administered with atazanavir.
Maltese: Il-konċentrazzjonijiet imnaqqsa ta' atazanavir fil-plażma jistgħu jkunu lkonsegwenza ta' żieda fil-pH gastriku jekk antaċidi, inklużi prodotti mediċinali buffered jingħataw ma'
English: Atazanavir with ritonavir has not been studied in patients with hepatic impairment.
Maltese: atazanavir+ ritonavir, kellhom rikaduta viroloġika.
English: If the patient has developed SJS or DRESS associated with the use of Atazanavir Krka, Atazanavir Krka may not be restarted.
Maltese: Fil-maġġoranza tal-pazjenti, tnaqqis kemm fl-esponiment għal voriconazole u għal atazanavir huwa mistenni.
English: LIPID LOWERING AGENTS HMG-CoA reductase inhibitors Simvastatin Lovastatin
Maltese: Hija meħtieġa l-kawtela u huwa rakkomandat monitoraġġ talkonċentrazzjoni terapewtika meta disponibbli.