FrancophonIA/ELRC3.0 huggingface dataset:
English: OPA/Aluminium/PVC - Aluminium blisters containing 30, 30 x 1 (unit dose) capsules.
Maltese: OPA/Aluminju/PVC - Folji tal-aluminju li jkun fihom 30, 30 x 1 (doża waħda) kapsula.
English: In 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: TM
Maltese: Ltd.
English: Resistance levels to atazanavir ranged from 3.5- to 29-fold without evidence of phenotypic cross resistance to other PIs.
Maltese: Il-livelli ta' reżistenza għal atazanavir i jvarjaw minn 3.5 għal 29 drabimingħajr evidenza ta' inkroċju ta' reżistenza fenotipika għal PIs oħra.
English: Atazanavir was approximately 86% bound to human serum proteins over a concentration range of 100 to 10,000 ng/ml.
Maltese: Atazanavir jeħel b'rata ta' bejn wieħed u ieħor 86% mal-proteini tad-demm uman f'konċentrazzjoni li tvarja minn 100 sa 10,000 ng/ml.
English: Cholelithiasis has been reported in patients receiving atazanavir (see section 4.8).
Maltese: Kolelitjażi ġiet irrapportata f'pazjenti li kienu qed jirċievu atazanavir (ara sezzjoni 4.8).
English: In HIV-infected patients with atazanavir/ritonavir at an increased dose of 400/100 mg once daily
Maltese: F'pazjenti infettati bl-HIV, b'atazanavir/ritonavir f'doża miżjuda ta' 400/100 mg darba kuljum
English: Voriconazole 200 mg twice daily (atazanavir 300 mg/ritonavir 100 mg once daily)
Maltese: Voriconazole 200 mg darbtejn kuljum (atazanavir 300 mg/ritonavir 100 mg darba kuljum)
English: uncommon: depression, disorientation, anxiety, insomnia, sleep disorder, abnormal dream
Maltese: mhux komuni: dipressjoni, disorjentament, ansjetà, nuqqas ta' rqad, disturb fl-irqad, ħolm mhux normali
English: Confidence interval.
Maltese: Interazzjonijiet oħra
English: The mechanism of interaction is decreased solubility of atazanavir as intra-gastric pH increases with proton pump inhibitors.
Maltese: Il-mekkaniżmu ta' interazzjoni huwa solubilità mnaqqsa ta' atazanavir hekk kif ilpH intragastriku jiżdied b'inibituri tal-proton pump.
English: Norgestimate Cmin ↑102% (↑77%
Maltese: Cmin ta' Norgestimate ↑102%
English: This side effect is usually not dangerous in adults and infants older than 3 months of age; but it might be a symptom of a serious problem.
Maltese: Dan l-effett sekondarju ġeneralment mhuwiex ta' periklu fl-adulti u t-trabi li għandhom iktar minn 3 xhur; iżda jaf ikun sintomu ta' problema serja.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Maltese:  DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
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: In repeat-dose toxicity studies, conducted in mice, rats, and dogs, atazanavir-related findings were generally confined to the liver and included generally minimal to mild increases in serum bilirubin and liver enzymes, hepatocellular vacuolation and hypertrophy, and, in female mice only, hepatic single-cell necrosis.
Maltese: Fi studji dwar l-effett tossiku minn dożi ripetuti fi ġrieden, firien u klieb, l-effetti relatati ma' atazanavir li nstabu kienu l-iktar limitati għall-fwied u kienu jinkludi ġeneralment żidiet minimali għal moderati fil-livelli tas-serum bilirubin u ta' l-enżimi tal-fwied, vakwolazzjoni u ipertrofija epatoċellulari, u, fil-ġrieden nisa biss, nekrosi epatika ta' ċellula waħda.
English: • if you are taking any of these medicines: see also Other medicines and Atazanavir Mylan - rifampicin, an antibiotic used to treat tuberculosis - astemizole or terfenadine (commonly used to treat allergy symptoms, these medicines may be available without prescription); cisapride (used to treat gastric reflux, sometimes called heartburn); pimozide (used to treat schizophrenia); quinidine or bepridil (used to correct heart rhythm); ergotamine, dihydroergotamine, ergonovine, methylergonovine (used to treat headaches); and alfuzosin (used to treat enlarged prostatic gland).
Maltese: Mediċini oħra u Atazanavir Mylan - rifampicin, antibijotiku li jintuża kontra t-tuberkulosi - astemizole jew terfenadine (jintuza ħafna kontra sintomi ta' allerġija, dawn il-mediċini jistgħu jingħataw mingħajr riċetta); cisapride (jintuża kontra rifluss gastriku, xi kultant imsejjaħ ħruq ta' stonku); primozide (jintuża għall-iskizofrenija); quinidine jew bepridil (jintuża biex jikkoreġi r-ritmu tal-qalb); ergotamine, dihydroergotamine, ergonovine,
English: Co-administration of Atazanavir Mylan with proton pump inhibitors is not recommended (see section 4.5).
Maltese: Amministrazzjoni fl-istess ħin ta' Atazanavir Mylan ma' inibituri proton pump m'hijiex rakkomandata (ara sezzjoni 4.5).
English: For patients not taking tenofovir, if atazanavir 300 mg/ritonavir 100 mg and H2-receptor antagonists are co-administered, a dose equivalent to famotidine 20 mg twice daily should not be exceeded.
Maltese: 300 mg/ritonavir 100 mg u antagonisti ta' riċettur H2 jingħataw flimkien, m'għandhiex tinqabeż doża ekwivalenti għal famotidine 20 mg darbtejn kuljum.
English: N-dealkylation and hydrolysis.
Maltese: Potassium hydroxide
English: Although not studied, there is a potential for an increase in pravastatin or fluvastatin exposure when co-administered with protease inhibitors.
Maltese: Għalkemm ma ġiex studjat, hemm potenzjal għal żieda fl-esponiment għal pravastatin or fluvastatin meta jingħataw flimkien ma' inibituri talprotease.
English: Other forms of this medicine may be available for use in children at least 3 months old and weighing at least 5 kg.
Maltese: Formulazzjonijiet oħra ta ' din il-mediċina tista tkun disponibbli għal pazjenti pedjatriċi li għandhom tal-inqas 3 xhur u li jiżnu tal-inqas 5 kg.
English: (wind), dry mouth, abdominal distension
Maltese: ħalq xott, distensjoni addominali
English: 30 hard capsules 60 hard capsules.
Maltese: 60 kapsula iebsa. 60 x 1 kapsula iebsa.
English: Concentrations of atazanavir with or without ritonavir are expected to be increased in patients with moderately or severely impaired hepatic function (see sections 4.2, 4.3, and 4.4).
Maltese: Atazanavir Mylan ma' ritonavir huwa kontraindikat f'pazjenti b'indeboliment epatiku moderat (ara sezzjonijiet 4.2, 4.4 u 5.2).
English: The compound selectively inhibits the virusspecific processing of viral Gag-Pol proteins in HIV- 1 infected cells, thus preventing formation of mature virions and infection of other cells.
Maltese: Is-sustanza tinibixxi b'mod selettiv ilproċessar speċifiku għall-virus tal-proteini virali Gag-Pol fiċ-ċelluli infettati bl-HIV-1, b'hekk ifixkel il-formazzjoni ta' virjoli maturi u l-infezzjoni ta' ċelluli oħra.
English: Chronic kidney disease
Maltese: Cyclosporin Tacrolimus Sirolimus
English: Grazoprevir Cmax: ↑524% (↑342%
Maltese: ↑524% (↑342% Cmin ta' Grazoprevir:
English: Study conducted in HIV infected patients
Maltese: Studji mwettqa fuq pazjenti infettati bl-HIV
English: Atazanavir Mylan 150 mg hard capsules are greenish-blue and blue opaque capsules with ‘MYLAN' over ‘AR150' printed in black ink on cap and body.
Maltese: Atazanavir Mylan 150 mg kapsuli ibsin huma kapsuli opaki ta' lewn aħdar-blu u blu, b''MYLAN' fuq ‘AR150' stampati b'linka sewda fuq l-għatu u l-korp.
English: Norbuprenorphine AUC ↑105%
Maltese: AUC ta' Norethindrone ↑110 %
English: Voriconazole 50 mg twice daily (atazanavir 300 mg/ritonavir 100 mg once daily)
Maltese: Voriconazole 50 mg darbtejn kuljum (atazanavir 300 mg/ritonavir 100 mg darba kuljum)
English: Atazanavir, simultaneous administration with ddI+d4T (fasted)
Maltese: Atazanavir (pm): kollha mogħtija mal-ikel
English: Ritonavir Cmax ↓11% (↓24% ↑4%)
Maltese: AUC ta' Ritonavir ↓11% (↓20% Cmax ta' Ritonavir ↓11% (↓24% Cmin ta' Ritonavir ↓19% (↓35%
English: In antiretroviral experienced adult patients
Maltese: F'pazjenti adulti li diġà ħadu kura antiretrovirali
English: Atazanavir/RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily).
Maltese: b Atazanavir/RTV ma' tenofovir/disoproxil fumarate/emtricitabine (pilloli ta' doża fissa ta'
English: Atazanavir Mylan 300 mg hard capsules atazanavir
Maltese: Atazanavir Mylan 300 mg kapsuli ibsin atazanavir
English: Atazanavir Cmax ↔6% (↓7% ↑20%)
Maltese: Cmax ta' Atazanavir ↔6% (↓7%
English: In case of withdrawal of ritonavir from the recommended atazanavir-boosted regimen (see section 4.4)
Maltese: Hemm riskju ta' telf tal-effett terapewtiku u ta' żvilupp ta' reżistenza (ara sezzjoni 4.3).
English: CARDIOVASCULAR AGENTS Antiarrhythmics
Maltese: PRESSJONI GĦOLJA ARTERJALI PULMONARI
English: Do not take Atazanavir Mylan
Maltese: Kif taħżen Atazanavir Mylan
English: postpartum a
Maltese: ANNESS II A.
English: Atazanavir Mylan capsules may be used by adults and children 6 years of age and older.
Maltese: Il-kapsuli Atazanavir Mylan jistgħu jintużaw minn adulti u tfal li mhumiex iżgħar minn 6 snin.
English: Increased plasma concentrations of quetiapine may lead to coma (see section 4.3).
Maltese: Żieda fil-konċentrazzjoni ta' quetiapine fil-plasma jistgħu jwasslu għal koma (ara sezzjoni 4.3).
English: While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.
Maltese: Filwaqt li sopressjoni virali b'terapija antiretrovirali effettiva ġiet ippruvata li tnaqqas b'mod sostanzjali r-riskju ta' trasmissjoni sesswali, riskju residwu ma jistax jiġi eskluż.
English: When compared to atazanavir 300 mg with ritonavir 100 mg without tenofovir disoproxil fumarate, atazanavir concentrations are expected to be additionally decreased by about 20%.
Maltese: Meta mqabbel ma' atazanavir 300 mg ma' ritonavir 100 mg mingħajr tenofovir disoproxil fumarate, il konċentrazzjonijiet ta' atazanavir huma mistennija li jonqsu b'mod addizzjonali b'madwar 20 %.
English: Other medicines and Atazanavir Mylan
Maltese: Mediċini oħra u Atazanavir Mylan
English: PDE5 inhibitors used for the treatment of erectile dysfunction: particular caution should be used when prescribing PDE5-inhibitors (sildenafil, tadalafil, or vardenafil) for the treatment of erectile dysfunction in patients receiving Atazanavir Mylan.
Maltese: Inibituri PDE5 użati għall-kura ta' disfunzjoni erettili: għandha tingħata attenzjoni partikolari meta jingħataw inibituri-PDE5 (sildenafil, tadalafil, jew vardenafil) b'riċetta ta' tabib għall-kura ta' disfunzjoni erettili f'pazjenti li jirċievu Atazanavir Mylan.
English: * In a combined analysis, atazanavir 300 mg and ritonavir 100 mg (n=33) was compared to
Maltese: * F'analiżi kombinata, atazanavir 300 mg u ritonavir 100 mg (n=33) tqabbel ma' atazanavir 400 mg mingħajr ritonavir (n=28).
English: Norbuprenorphine Cmin ↑101%
Maltese: AUC ta' Norbuprenorphine ↑105% Cmax ta' Norbuprenorphine ↑61% Cmin ta' Norbuprenorphine ↑101%
English: In a small number of patients without a functional CYP2C19 allele, significantly increased voriconazole exposures are expected (see section 4.5).
Maltese: F'għadd żgħir ta' pazjenti mingħajr allele CYP2C19 funzjonali, hu mistenni li jkun hemm żieda sinifikattiva fl-esponimenti għal voriconazole (ara sezzjoni 4.5).
English: Each capsule contains 300 mg atazanavir (as sulphate)
Maltese: Kull kapsula fiha 300 mg atazanavir (bħala sulfat).
English: Atazanavir Cmin ↓20% (↓31% ↓8%) In Healthy volunteers with atazanavir/ritonavir at an increased dose of 400/100 mg once daily
Maltese: AUC ta' Atazanavir ↓23% (↓32% Cmax ta' Atazanavir ↓23% (↓33% Cmin ta' Atazanavir ↓20% (↓31% F'voluntiera b'saħħithom b'atazanavir/ritonavir b'doża miżjuda ta' 400/100 mg darba kuljum Famotidine 40 mg darbtejn kuljum
English: All patients HIV RNA <400 copies/ml, %
Maltese: HIV RNA <400 kopji/ml, % a Il-pazjenti kollha
English: The recommended dose of Atazanavir Mylan capsules for adults is 300 mg once daily with 100 mg ritonavir once daily, taken with food, in combination with other anti-HIV medicines.
Maltese: Id-doża rakkomandata għall-adulti tal-kapsuli ta' Atazanavir Mylan hija normalment ta' 300 mg ma' 100 mg ritonavir darba kuljum li jittieħdu mal-ikel, flimkien ma' mediċini oħra ta' kontra l-HIV.
English: CORTICOSTEROIDS Fluticasone propionate intranasal 50 µg 4 times daily for 7 days
Maltese: Fluticasone propionate li jingħata minn ġol-imnieħer 50 µg 4 darbiet kuljum għal 7 ijiem (ritonavir 100 mg kapsuli darbtejn kuljum)
English: Co-administration with simvastatin or lovastatin (see section 4.5).
Maltese: L-għoti flimkien ma' simvastatin jew lovastatin (ara sezzjoni 4.5).
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: • vomiting, diarrhoea, abdominal pain (stomach pain of discomfort), nausea, dyspepsia (indigestion)
Maltese: • rimettar, dijarea, uġigħ addominali (uġigħ ta' żaqq ta' skumditа), nawseja, dispepsja
English: Atazanavir Cmax ↔9% (↓5% ↑26%)
Maltese: Cmax ta' Atazanavir ↔9% (↓5%
English: The risk of a further decrease in atazanavir exposure is expected when atazanavir is given with medicinal products known to reduce its exposure (e.g., tenofovir disoproxil or H2-receptor antagonists).
Maltese: Ir-riskju ta' aktar tnaqqis fl-espożizzjoni ta' atazanavir huwa mistenni meta atazanavir jingħata ma' prodotti mediċinali magħrufin li jnaqqsu l-espożizzjoni tiegħu (eż. tenofovir disoproxil jew antagonisti tar-riċettur ta' H2).
English: 25-O-desacetyl-rifabutin AUC
Maltese: AUC ta' 25-O-desacetyl-rifabutin Cmax ta' 25-O-desacetyl-rifabutin Cmin ta' 25-O-desacetyl-rifabutin
English: Sildenafil is also used for the treatment of erectile dysfunction.
Maltese: Sildenafil jintuża wkoll għall-kura ta' disfunzjoni erettili.
English: Raltegravir C12hr↑ 77%
Maltese: AUC ta' Raltegravir ↑41% Cmax ta' Raltegravir ↑24% C12hr ta' Raltegravir ↑77%
English: Each capsule contains 200 mg atazanavir (as sulphate)
Maltese: Kull kapsula fiha 200 mg atazanavir (bħala sulfat).
English: • chest pain, malaise (generally feeling unwell), fever
Maltese: • uġigħ fis-sider, malaise (kundizzjoni ġenerali ħażina), deni
English: * When compared to atazanavir 300 mg and ritonavir 100 mg without nevirapine.
Maltese: * Meta mqabbel ma' atazanavir 300 mg u ritonavir 100 mg mingħajr nevirapine.
English: PVC/PVDC/Aluminium blisters containing 30, 60, 60 x 1 (unit dose) capsules.
Maltese: Għal folji tal-PVC/PVDC/Aluminju li jkun fihom 30, 60, 60 x 1 (doża waħda) kapsula.
English: Each hard capsule contains 300 mg atazanavir (as sulphate).
Maltese: Kull kapsula iebsa għandha 300 mg atazanavir (bħala sulphate).
English: Week 48 Week 96 Week 48 Week 96 Week 48 Week 96 HIV RNA Mean Change from Baseline, log10 copies/ml All patients
Maltese: Differenza skont il-Medja tal-Ħin ATV/RTV-LPV/RTV [97.5% CId] Ġimgħa 48 Ġimgħa 96 Ġimgha 48 Ġimgha 96 Ġimgha 48 Ġimgħa 96 HIV RNA Bidla Medja mill-Linja Bażi, log10 kopji/ml Il-pazjenti kollha
English: Co-administration of Atazanavir Mylan and medicinal products that induce CYP3A4 is not recommended (see sections 4.3 and 4.5).
Maltese: L-użu ta' Atazanavir Mylan u mediċinali oħra li jistimulaw CYP3A4 mhux irrikmandat (ara sezzjonijiet 4.3 u 4.5).
English: If a higher dose of an H2-receptor antagonist is required (e.g., famotidine 40 mg twice daily or equivalent) an increase of the atazanavir/ritonavir dose from 300/100 mg to 400/100 mg can be considered.
Maltese: Jekk tkun meħtieġa doża ogħla ta' antagonista ta' riċettur ta' H2 (eż. famotidine 40 mg darbtejn kuljum jew ekwivalenti), tista' tiġi kkunsidrata żieda fid-doża ta' atazanavir/ritonavir minn 300/100 mg għal 400/100 mg.
English: Overall in this study, 182 paediatric patients (81 antiretroviral-naive and 101 antiretroviral-experienced) received once daily atazanavir (capsule or powder formulation), with or without ritonavir, in combination with two NRTIs.
Maltese: Globalment f'dan l-istudju, 182 pazjent pedjatriku (81 pazjent li qatt ma kienu kkurati b'antiretrovirali fil-passat u 101 li kienu kkurati b'antiretrovirali fil-passat), irċivew atazanavir darba kuljum (f'għamla ta' kapsula jew trab) bi jew mingħajr ritonavir, flimkien ma' żewġ NRTIs.
English: Treatment-Experienced Atazanavir
Maltese: Is-sustanza attiva hi atazanavir.
English: In clinical trials of antiretroviral treatment naive patients treated with boosted atazanavir, the I50L substitution did not emerge in any patient without baseline PI substitutions.
Maltese: F'esperimenti kliniċi ta' pazjenti li qatt qabel ma ħadu kura antiretrovirali li ġew ittratati b'atazanavir ibbustjat, is- sostituzzjonijiet I50L ma dehrtix fl-ebda pazjent mingħajr sostituzzjonijiet PI tal-linja bażi.
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART).
Maltese: Għalkemm l-etjoloġija hi kkunsidrata li hi minn ħafna fatturi (inklużi użu ta' corticosteroid, konsum ta' alkoħol, immunosoppressjoni gravi, indiċi tal-massa tal-ġisem ogħla), każi ta' ostjonekrosi ġew irrappurtati b'mod partikulari f'pazjenti bil-marda ta' l-HIV avvanzata u/jew espożizzjoni fit-tul għatterapija antiretrovirali mħallta (CART).
English: Ketoconazole and itraconazole should be used cautiously with atazanavir/ritonavir.
Maltese: Ketoconazole u itraconazole għandhom jintużaw b'kawtela ma' atazanavir/ritonavir.
English: • hepatosplenomegaly (enlargement of the liver and spleen)
Maltese: • edema (nefħa) ħepatosplenomegalija (tkabbir tal-fwied u tal-milsa)
English: Due to phenytoin/phenobarbital inducing effect, a reduction in atazanavir exposure cannot be ruled out combination with atazanavir /ritonavir.
Maltese: Phenobarbital u phenytoin għandhom jintużaw b'attenzjoni f'kombinazzjoni ma' atazanavir/ritonavir.
English: (400 mg/100 mg twice daily) n=443
Maltese: Lopinavir/ritonavirc (400 mg/100 mg darbtejn kuljum) n=443
English: For oral use.
Maltese: NA = mhux applikabbli.
English: If atazanavir/ritonavir with both tenofovir disoproxil fumarate and an H2-receptor antagonist are co-administered, a dose increase of atazanavir to 400 mg with 100 mg of ritonavir is recommended.
Maltese: Jekk atazanavir/ritonavir kemm ma' tenofovir disoproxil fumarate kif ukoll ma' antagonist ta' riċettur H2 jingħataw flimkien, hija rakkomandata żieda fid-doża ta' atazanavir għal 400 mg ma' 100 mg ta' ritonavir.
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 atazanavir400 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: ANTIEPILEPTICS Carbamazepine
Maltese: Carbamazepine
English: C-atazanavir, 79% and 13% of the total radioactivity was recovered in the faeces and urine, respectively.
Maltese: 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: The mechanism is UGT1A1 inhibition.
Maltese: Il-mekkaniżmu huwa inibizzjoni ta' UGT1A1.
English: e
Maltese: JIS
English: Slovenská republika Mylan s r. o Tel: +421 2 32 199 100
Maltese: Mylan Pharmaceuticals, S.L. Tel: +34 900 102 712
English: There were fewer treatment discontinuations in the unboosted atazanavir group (1 vs. 4 subjects in the atazanavir + ritonavir group).
Maltese: Kien hemm anqas twaqqif tal-kura fil-grupp ta' atazanavir mhux imsaħħaħ (1 kontra 4 individwi filgrupp ta' atazanavir + ritonavir).
English: Concomitant use of salmeterol and Atazanavir Mylan may result in increased cardiovascular adverse events associated with salmeterol.
Maltese: L-użu fl-istess ħin ta' salmeterol u Atazanavir Mylan jista' jirriżulta f'żieda fl-episodji kardjovaskulari avversi assoċjati ma' salmeterol.
English: It is especially important to mention these:
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt ilġilda:
English: In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Maltese: F'pazjenti infettati bl-HIV b'defiċjenza gravi ta' immunità fl-istess żmien li bdew taħlita ta' terapija antiretrovirali (CART), tista' tinħoloq reazzjoni ta' infjammazzjoni għall-infezzjonijiet bla sintomi jew dawk opportunistiċi residwali.
English: The most frequently reported laboratory abnormality in paediatric patients receiving atazanavir was elevation of total bilirubin (≥ 2.6 times ULN, Grade 3-4) which occurred in 45% of patients.
Maltese: L-aktar anormalità fil-laboratorju frekwenti rrappurtata f'pazjenti pedjatriċi li kienu qed jirċievu atazanavir kienet livelli ogħla ta' bilirubina totali (≥2.6 darbiet aktar mil-livelli normali ta' fuq (ULN), Grad 3-4) li seħħet f'45% tal-pazjenti.
English: reduced solubility of atazanavir with increasing pH related to the presence of anti-acid agent in didanosine buffered tablets.
Maltese: Ilmekkaniżmu ta' interazzjoni huwa solubilità mnaqqsa ta' atazanavir hekk kif tiżdied il-pH relatata malpreżenza ta' sustanza kontra l-aċidi fil-pilloli buffered ta' didanosine.
English: The risk of myopathy including rhabdomyolysis may also be increased with atorvastatin, which is also metabolised by CYP3A4.
Maltese: Ir-riskju ta' mijopatija li tinkludi rabdomijoliżi jista' jiżdied ukoll b'atorvastatin, li wkoll jiġi metabolizzat minn CYP3A4.
English: Atazanavir Mylan 300 mg hard capsules are red and greenish-blue opaque capsules with ‘MYLAN' over ‘AR300' printed in black ink on cap and body.
Maltese: Atazanavir Mylan 300 mg kapsuli ibsin huma kapsuli opaki ta' lewn aħmar u aħdar-blu, b''MYLAN' fuq ‘AR300' stampati b'linka sewda fuq l-għatu u l-korp.
English: boceprevir Cmax ↔7%
Maltese: AUC ta' Boceprevir ↔5% Cmax ta' Boceprevir ↔7% Cmin ta' Boceprevir ↔18%
English: Atazanavir Cmax ↓21% (↓36% ↓4%)
Maltese: AUC ta' Atazanavir ↓21% (↓34% Cmax ta' Atazanavir ↓21% (↓36% Cmin ta' Atazanavir ↓19% (↓37%
English: In case of withdrawal of ritonavir from the initial recommended ritonavir boosted regimen (see section 4.4), unboosted atazanavir could be maintained in patients with mild hepatic impairment at a dose of 400 mg and in patients with moderate hepatic impairment with a reduced dose of 300 mg once daily with food (see section 5.2).
Maltese: Fil-każ li ritonavir jiġi rtirat mill-iskeda inizjali rakkomandata msaħħa b'ritonavir (ara sezzjoni 4.4), atazanavir mhux imsaħħaħ ikun jista' jinżamm f'pazjenti b'indeboliment epatiku ħafif f'doża ta' 400 mg u f'pazjenti b'indeboliment epatiku moderat b'doża mnaqqsa ta' 300 mg darba kuljum malikel (ara sezzjoni 5.2).
English: Rifabutin Cmin ↑40% (↑5% ↑87%)
Maltese: AUC ta' Rifabutin ↑48% (↑19% Cmax ta' Rifabutin ↑149% (↑103% Cmin ta' Rifabutin ↑40% (↑5%
English: Among naive patients treated with atazanavir 300 mg once daily with 100 mg ritonavir once daily for a median duration of 96 weeks, 48% had Grade 3-4 total bilirubin elevations (see section 4.4).
Maltese: Fost pazjenti li qatt ma kienu ħadu l-kura qabel, ikkurati b'atazanavir 300 mg darba kuljum b'100 mg ta' ritonavir darba kuljum għal perijodu ta' żmien medju ta' 96 ġimgħa, 48% kellhom żieda fil-bilirubin totali ta' Grad 3-4 (ara sezzjoni 4.4).
English: BATCH NUMBER
Maltese:  NUMRU TAL-LOTT