FrancophonIA/ELRC3.0 huggingface dataset:
English: Atazanavir Krka 150 mg and 200 mg hard capsules are available in containers containing 60 hard capsules; in a box.
Maltese: Krka 150 mg u 200 mg kapsuli ibsin huma disponibbli b'reċipjenti li fihom 60 kapsula iebsa, f'kaxxa.
English: The decrease in AUC, cmax, and cmin was not mitigated when an increased dose of atazanavir /ritonavir (400/100 mg once daily) was temporally separated from omeprazole by 12 hours.
Maltese: atazanavir/ritonavir (400/100 mg darba kuljum) ġiet separata temporalment minn omeprazole bi 12-il siegħa.
English: Co-administration of Atazanavir Krka with other hormonal contraceptives or oral contraceptives containing progestogens other than norgestimate or norethindrone has not been studied, and therefore should be avoided (see section 4.5).
Maltese: Krka ma' kontraċettivi ormonali oħrajn li jkun fihom progestogens, ħlief norgestimate jew norethindrone ma ġiex studjat, u għalhekk għandu jiġi evitat (ara sezzjoni 4.5).
English: Atazanavir Krka 300 mg hard capsules Each hard capsule contains 300 mg atazanavir (as sulphate).
Maltese: Kull kapsula iebsa fiha 300 mg atazanavir (bħala sulfat).
English: Study 045 is a randomised, multicenter trial comparing atazanavir /ritonavir (300/100 mg once daily) and atazanavir /saquinavir (400/1,200 mg once daily), to lopinavir + ritonavir (400/100 mg fixed dose combination twice daily), each in combination with tenofovir disoproxil (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: u ma' lopinavir + ritonavir (400/100 mg flimkien f'doża fissa kombinata, darbtejn kuljum), kull waħda flimkien ma' tenofovir disoproxil (ara sezzjonijiet 4.5 u 4.8) u NRTI wieħed, f' pazjenti li kellhom falliment viroloġiku f'żewġ kuri jew iżjed mogħtija qabel li kien fihom għallinqas PI, NRTI u NNRTI wieħed.
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
English: Atazanavir AUC ↑43% (↑30% Atazanavir cmax ↑12% (↑1% Atazanavir cmin ↑23% (↑13% Grazoprevir AUC: ↑958% (↑678% Grazoprevir cmax: ↑524% (↑342% Grazoprevir cmin: ↑1064% (↑696%
Maltese: AUC ta' Atazanavir ↑43% (↑30% cmax ta' Atazanavir ↑12% (↑1% ↑24%) cmin ta' Atazanavir ↑23% (↑13%
English: (300 mg/ 100 mg once daily (n=120)
Maltese: ATV/RTVb (300 mg/ 100 mg darba kuljum) (n=120)
English: NAME OF THE MEDICINAL PRODUCT Atazanavir Krka 150 mg hard capsules atazanavir
Maltese: Krka 150 mg kapsuli ibsin Atazanavir
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 tal protease.
English: H2-Receptor antagonists Without Tenofovir disoproxil In HIV-infected patients with atazanavir/ritonavir at the recommended dose 300/100 mg once daily
Maltese: F'pazjenti infettati bl-HIV, b'atazanavir/ritonavir fid-doża rakkomandata ta' 300/100 mg darba kuljum
English: The mechanism of interaction is CYP3A4 inhibition by atazanavir and/or ritonavir.
Maltese: Il-mekkaniżmu ta' interazzjoni huwa l inibizzjoni ta' CYP3A4 minn atazanavir/ritonavir.
English: Concomitant use of Atazanavir Krka /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' Atazanavir Krka/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
English: ANTIPSYCHOTICS Quetiapine
Maltese: ANTIPSIKOTIĊI
English: The mechanism of interaction is decreased solubility of atazanavir as intra-gastric pH increases with proton pump inhibitors.
Maltese: intragastriku jiżdied b'inibituri tal proton pump.
English: Capsule shell of Atazanavir Krka 200 mg hard capsules Body: titanium dioxide (E171), yellow ferric oxide (E172), red ferric oxide (E172) and gelatine Cap: titanium dioxide (E171), yellow ferric oxide (E172), red ferric oxide (E172), gelatine and ink (shellac, black ferric oxide (E172), potassium hydroxide
Maltese: Korp: titanium dioxide (E171), yellow ferric oxide (E172), red ferric oxide (E172) u gelatine Għatu: titanium dioxide (E171), yellow ferric oxide (E172), red ferric oxide (E172), gelatine u linka (shellac, black ferric oxide (E172), potassium hydroxide)
English: Proton pump inhibitors Omeprazole 40 mg once daily (atazanavir 400 mg once daily with ritonavir 100 mg once daily)
Maltese: Omeprazole 40 mg darba kuljum (atazanavir 400 mg darba kuljum ma' ritonavir 100 mg darba kuljum)
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: In an open-label, randomised, comparative study following a 26- to 30-week induction phase with atazanavir 300 mg + ritonavir 100 mg once daily and two NRTIs, unboosted atazanavir 400 mg once daily and two NRTIs administered during a 48-week maintenance phase (n=87) had similar antiviral efficacy compared with atazanavir + ritonavir and two NRTIs (n=85) in HIV infected subjects with fully suppressed HIV replication, as assessed by the proportion of subjects with HIV RNA < 50 copies/ml: 78% of subjects on unboosted atazanavir and two NRTIs compared with 75% on atazanavir + ritonavir and two NRTIs.
Maltese: (n=85) f'individwi infettati bl-HIV b'replikazzjoni tal-HIV kompletament mrażżna, kif ġie vvalutat mill-proporzjon ta' individwi b'HIV RNA <50 kopja/ml: 78 % tal-individwi fuq atazanavir mhux imsaħħaħ u żewġ NRTIs meta mqabbla ma' 75 % fuq atazanavir+ ritonavir u żewġ NRTIs.
English: a Mean baseline CD4 cell count was 214 cells/mm3 (range 2 to 810 cells/mm3) and mean baseline plasma HIV-1 RNA was
Maltese: L-għadd ta' ċelloli CD4 fil-linja bażi kien ta' 214-il ċellola/mm3 (medda: bejn 2 u 810 ċelloli/mm3) u l-linja bażi medja ta '
English: -3.13 (n=379)
Maltese: -3.09 (n=397) -3.21 (n=360) -3.13 (n=379) -3.19 (n=340)
English: Your doctor will evaluate how severe yourliver disease is before deciding whether you can take Atazanavir Krka - if you are taking any of these medicines: see also Other medicines and Atazanavir Krka - 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) - quetiapine (used to treat schizophrenia, bipolar disorder and major depressive disorder), lurasidone (used to treat schizophrenia)
Maltese: - jekk qed tieħu kontraċettiv orali (“Il-Pill”) ma' Atazanavir Krka biex tiġi evitata tqala, aċċerta ruħek li teħodha eżatt kif ikun tak parir it-tabib tiegħek u tinsa tieħu l-ebda doża - kull mediċina użata biex tikkura mard relatat mal-aċidu fl-istonku (eż. antaċidi li għandhom jittieħdu siegħa qabel Atazanavir Krka jew sagħtejn wara li tieħu Atazanavir Krka, imblokkaturi ta' H2 bħal famotidine u inibituri proton pump bħal omeprazole) - mediċini biex ibaxxu l-pressjoni, ir-rata tat-taħbit tal-qalb, jew biex jirranġaw ir-ritmu tal-qalb
English: At high doses that lead to high drug exposures, jaundice due to indirect (unconjugated) hyperbilirubinaemia (without associated liver function test changes) or PR interval prolongations may be observed (see sections 4.4 and 4.8).
Maltese: (mhux konjugata) (mhux konnessa ma' tibdil fit-test tal-funzjoni tal-fwied) jew titwil ta' l-intervall PR (ara sezzjonijiet 4.4. or 4.8).
English: Atazanavir Krka with food and drink
Maltese: atazanavir, fuq il-bażi ta' dan it tagħrif.
English: Atazanavir should not be used in combination with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index.
Maltese: Atazanavir m'għandux jintuża f'kombinazzjoni ma' prodotti mediċinali li huma substrati ta' CYP3A4 u li għandhom indiċi terapewtiku dejjaq.
English: 15 to less than 35
Maltese: 50 sa <100
English: Co-administration of atazanvir with glecaprevir/pibrentasvir 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: żidiet fl-ALT minħabba żieda sinifikanti fil-konċentrazzjonijiet fil-plażma ta' glecaprevir u pibrentasvir (ara sezzjoni 4.3).
English: Atazanavir Krka 300 mg with ritonavir 100 mg may not provide sufficient exposure to atazanavir, especially when the activity of atazanavir or the whole regimen may be compromised due to drug resistance.
Maltese: Atazanavir Krka 300 mg ma' ritonavir 100 mg jista' ma jipprovdix espożizzjoni biżżejjed għal atazanavir, b'mod speċjali meta l-attività ta' atazanavir tar-reġimen kollu tkun tista' tiġi kompromessa minħabba reżistenza għall-mediċina.
English: If atazanavir is coadministered with parenteral midazolam, it should be done in an intensive care unit (ICU) or similar setting which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation.
Maltese: midazolam parenterali, dan għandu jsir f'taqsima tal-kura intensiva (ICU) jew f'ambjent simili li jiżgura monitoraġġ kliniku mill-qrib u mmaniġġjar mediku xieraq f'każ ta' qtugħ ta'
English: Atazanavir, dosed 1 hr after ddI+d4T (fasted) Atazanavir AUC ↔3% (↓36% Atazanavir cmax ↑12% (↓33% Atazanavir cmin ↔3% (↓39%
Maltese: AUC ta' Atazanavir ↔3 % (↓36 % cmax ta' Atazanavir ↑12 % (↓33 % cmin ta' Atazanavir ↔3 % (↓39 %
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Maltese: Mediċini oħra u Atazanavir Krka M'għandekx tieħu Atazanavir Krka ma' ċerti mediċini.
English: Children receiving Atazanavir Krka may require their heart to be monitored.
Maltese: Tfal li jirċievu Atazanavir Krka jista' jkollhom bżonn li qalbhom tiġi mmonitorjata.
English: Co-administration with atazanavir 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: Also see PULMONARY ARTERIAL HYPERTENSION in this table for futher information regarding co- administration of atazanavir with sildenafil.
Maltese: PULMONARI f'din it-tabella għal aktar informazzjoni dwar lgħoti fl-istess ħin ta' atazanavir u sildenafil.
English: Week 48: -3% [-7.6%, 1.5%] Week 96: 2.2% [-2.3%, 6.7%] HIV RNA <50 copies/ml, % by Baseline Characteristic d
Maltese: Ġimgħa 96: 2.2% [-2.3%, 6.7%]
English: Atazanavir concentrations were greatly decreased when coadministered with didanosine (buffered tablets) and stavudine.
Maltese: Il-konċentrazzjonijiet ta' atazanavir naqsu ħafna meta ngħata fl-istess ħin ma' didanosine (pilloli buffered) u stavudine.
English: Other medicines and Atazanavir Krka
Maltese: Prodotti mediċinali skont il qasam terapewtiku
English: CD4 Mean Change from Baseline, cells/mm by Baseline Characteristic
Maltese: Bidla Medja fil-CD4 mill-Linja Bażi, ċelluli/mm3 skont il-Karatteristiċi tal-Linja Bażi
English: The mechanism of efavirenz/atazanavir interaction is CYP3A4 induction.
Maltese: Il-mekkaniżmu talinterazzjoni ta' efavirenz/atazanavir huwa l-induzzjoni ta' CYP3A4.
English: There is a risk of loss of therapeutic effect and development of resistance (see section 4.3).
Maltese: Hemm riskju ta' telf tal effett terapewtiku u ta' żvilupp ta' reżistenza (ara sezzjoni 4.3).
English: (See section 4.4 Withdrawal of ritonavir only under restrictive conditions).
Maltese: (ara sezzjoni 4.4).
English: Nephrolithiasis
Maltese: Salmeterol
English: Atazanavir Krka 150 mg and 200 mg hard capsules HDPE tablet container with child-resistant tamper evident PP with desiccant closure: 60 hard capsules, in a box.
Maltese: rifabutin għal 150 mg darbtejn fil-ġimgħa fi ġranet fissi huwa rakkomandat għal pazjenti li għalihom, id-doża ta' 150 mg 3 darbiet fil-ġimgħa mhijiex ittollerata.
English: Amiodarone,
Maltese: atazanavir.
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 %
English: 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)
Maltese: 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 fil muskoli)
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 għat terapija antiretrovirali mħallta (CART).
English: In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Maltese: F'pazjenti infettati bl-HIV b'defiċjenza immunitarja gravi meta jkunu qed jieħdu taħlita ta' terapija antiretrovirali (CART), tista' tkun ikkaġunata reazzjoni ta' infjammazzjoni għal patoġeni bla sintomi jew dawk opportunistiċi residwali u din tista' tikkaġuna kundizzjonijiet kliniċi serji, jew aggravar tas sintomi.
English: Co-administration of salmeterol and Atazanavir Krka is not recommended (see section 4.5).
Maltese: prodotti mediċinali magħrufin li jaffettwaw l-espożizzjoni għal atazanavir (ara sezzjoni 4.5).
English: the clarithromycin/atazanavir interaction is CYP3A4 inhibition.
Maltese: Il-mekkaniżmu ta' interazzjoni ta' clarithromycin/atazanavir huwa linibizzjoni ta' CYP3A4.
English: The safety profile in these studies was overall comparable to that seen in previous paediatric and adult studies.
Maltese: dak osservat fi studji pedjatriċi u fuq l-adulti preċedenti.
English: Withdrawal of ritonavir only under restrictive conditions The recommended standard treatment is Atazanavir Krka boosted with ritonavir, ensuring optimal pharmacokinetic parameters and level of virologic suppression.
Maltese: Il-kura standard rakkomandata hija Atazanavir Krka imsaħħaħ b'ritonavir, li din tiżgura l-aqwa parametri farmakokinetiċi u livell ta' soppressjoni viroloġika.
English: In patients with pre-existing conduction problems (second degree or higher atrioventricular or complex bundle-branch block), Atazanavir Krka should be used with caution and only if the benefits exceed the risk (see section 5.1).
Maltese: F'pazjenti li diġà għandhom problemi fit-trasmissjoni (bundle-branch tat-tieni grad jew ogħla, atrijuventrikulari jew kumpless), Atazanavir Krka għandu jintuża b'attenzjoni u biss jekk il-vantaġġi huma akbar mir-riskji (ara sezzjoni 5.1).
English: Atazanavir Krka with ritonavir must not be used in patients with moderate to severe hepatic impairment (see sections 4.3, 4.4 and 5.2).
Maltese: L-użu ta' Atazanavir Krka u mediċinali oħra li jistimulaw CYP3A4 mhux irrikmandat (ara sezzjonijiet 4.3 u 4.5).
English: No single dose of famotidine should exceed 20 mg, and the total daily dose of famotidine should not exceed 40 mg. the need to consider that co-administration of voriconazole and atazanavir without ritonavir may affect atazanavir concentrations co-administration of fluticasone and atazanavir without ritonavir may increase fluticasone concentrations relative to fluticasone given alone if an oral contraceptive is administered with atazanavir without ritonavir, it is recommended that the oral contraceptive contain no more than 30 µg of ethinyloestradiol no dose adjustment of lamotrigine is required
Maltese: - jekk ma' atazanavir mingħajr ritonavir jingħata kontraċettiv orali, huwa rakkomandat li l kontraċettiv orali ma jkunx fih aktar minn 30 µg ta' ethinyloestradiol - ma hemmx bżonn aġġustament fid-doża ta' lamotrigine
English: - If tenofovir disoproxil or an H2-receptor antagonist is needed, a dose increase to Atazanavir Krka
Maltese: tenofovir disoproxil fumarate, huwa rakkomandat li atazanavir
English: Tenofovir disoproxilfumarate AUC ↑37% (↑30% ↑45%) Tenofovir disoproxil fumarate Cmax
Maltese: AUC ta' Tenofovir disoproxilfumarate Cmax ta' Tenofovir disoproxil fumarate Cmin ta' Tenofovir disoproxil fumarate
English: Chronic kidney disease
Maltese: Mard tal-kliewi kroniku
English: Hard gelatine capsule, size no. 00.
Maltese: Kapsula tal-ġelatina iebsa, ta' daqs nru 00.
English: Atazanavir (pm): all administered with food
Maltese: Atazanavir (pm): kollha mogħtija mal ikel
English: Particular caution should be used when prescribing Atazanavir Krka 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: Mhux eskluż il-potenzjal ta' l-effetti kardijaċi ta' dan il-prodott fil-bniedem (ara sezzjonijiet 4.4 u 4.8).
English: - Liver problems may uncommonly happen.
Maltese: - Problemi fil-fwied jistgħu jseħħu b'mod mhux komuni.
English: A dose equivalent to famotidine 40 mg twice daily should not be exceeded.
Maltese: Famotidine 40 mg darbtejn kuljum
English: It is especially important to mention these: - other medicines to treat HIV infection (e.g. indinavir, nevirapine and efavirenz) - boceprevir and sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C) - sildenafil, vardenafil, or tadalafil (used by men to treat impotence (erectile dysfunction)) - if you are taking an oral contraceptive ("the Pill") with Atazanavir Krka to prevent pregnancy,
Maltese: Huwa ferm importanti li dawn li ġejjin jissemmgħu: - mediċini oħra għal kura ta' l-infezzjoni ta' l-HIV (eż. indinavir, nevirapine u efavirenz) - boceprevir u sofosbuvir/velpatasvir/voxilaprevir (jintużaw biex jikkuraw epatite Ċ)
English: Antacids
Maltese: Effikaċja
English: NAME OF THE MEDICINAL PRODUCT Atazanavir Krka 300 mg hard capsules atazanavir
Maltese: jekk atazanavir 300 mg/ritonavir
English: Glecaprevir 300 mg / pibrentasvir 120 mg once daily
Maltese: Glecaprevir 300 mg / pibrentasvir 120 mg darba kuljum (atazanavir 300 mg / ritonavir 100 mg darba kuljum*)
English: Atazanavir cmax ↓89% (↓94%
Maltese: ritonavir cmax ↓ 27%
English: % (responder/evaluable) NA
Maltese: MANIFATTUR(I) RESPONSABBLI
English: While the concentration of ethinyloestradiol was increased with atazanavir given alone, due to both UGT and CYP3A4 inhibition by atazanavir, the net effect of atazanavir/ritonavir is a decrease in ethinyloestradiol levels because of the inducing effect of ritonavir.
Maltese: Filwaqt li l-konċentrazzjoni ta' ethinyloestradiol żdiedet ma' atazanavir mogħti waħdu, minħabba l inibizzjoni kemm ta' UGT kif ukoll ta' CYP3A4 minn atazanavir, l-effett nett ta' atazanavir/ritonavir huwa tnaqqis fil-livelli ta' ethinyloestradiol minħabba l-effett ta' induzzjoni ta' ritonavir.
English: Through 96 weeks of treatment, mean HIV RNA changes from baseline for atazanavir + ritonavir and lopinavir + ritonavir met criteria for non-inferiority based on observed cases.
Maltese: Matul is-96 ġimgħa ta' kura, il-bidliet medji mil-linja bażi fl-HIV RNA għal atazanavir+ ritonavir u lopinavir + ritonavir, issodisfaw il-kriterji ta' mingħajr inferjorità ibbażati fuq każijiet osservati.
English: - Keep this leaflet.
Maltese: manutenzjoni.
English: Atazanavir is expected to increase plasma levels of lurasidone due to CYP3A4 inhibition.
Maltese: Atazanavir huwa mistenni li jżid il livelli ta' lurasidone fil-plasma minħabba inibizzjoni ta' CYP3A4.
English: When Atazanavir Krka and ritonavir are co-administered, the metabolic drug interaction profile for ritonavir may predominate because ritonavir is a more potent CYP3A4 inhibitor than atazanavir.
Maltese: Meta Atazanavir Krka u ritonavir jingħataw flimkien, il-profil metaboliku ta' interazzjoni ta' ritonavir jista' jippredomina għax ritonavir huwa inibitur ta' CYP3A4 iktar qawwi minn atazanavir.
English: (atazanavir 300 mg / ritonavir 100 mg once daily*)
Maltese: (atazanavir 300 mg darba kuljum ma' ritonavir 100 mg darba kuljum)
English: If you have liver problems, including hepatitis B or C infection, you may experience a worsening of your liver problems.
Maltese: Jekk għandek problemi fil fwied, inkluż infezzjoni tal-epatite B jew Ċ, tista' tesperjenza aggravar tal-problemi fil-fwied tiegħek.
English: The concomitant use of quinidine is contraindicated (see section 4.3).
Maltese: Krka ma' atorvastatin mhijiex rakkomandata (ara sezzjoni 4.5).
English: Data from concomitant use of parenteral midazolam with other protease inhibitors suggest a possible 3-4 fold increase in midazolam plasma levels.
Maltese: midazolam parenterali ma' inibituri oħrajn tal-protease jissuġġerixxi żieda possibbli ta' 3-4 darbiet fil-livelli ta' midazolam fil-plażma.
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 %)
English: Co-administration of voriconazole and Atazanavir Krka with ritonavir is not recommended, unless an assessment of the benefit/risk justifies the use of voriconazole.
Maltese: voriconazole u atazanavir ma' ritonavir mhuwiex rakkomandat sakemm valutazzjoni tal benefiċċju/riskju għall-pazjent ma tiġġustifikax l-użu ta'
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 300 mg atazanavir (as sulphate).
Maltese: Kull kapsula fiha 300 mg atazanavir (bħala sulphate).
English: KRKA-POLSKA Sp. z o.o.
Maltese: L-użu fl-istess ħin ta' St.
English: Further information on Nasym can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/nasym.
Maltese: ema.europa.eu/medicines/veterinary/EPAR/nasym.
English: Nasym contains bovine respiratory syncytial virus strain Lym-56.
Maltese: Nasym fih il-virus sinktjali respiratorju bovin razza Lym-56.
English: Nasym received a marketing authorisation valid throughout the EU on 29 July 2019.
Maltese: Nasym ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fi 29/07/2019.
English: Nasym is a vaccine.
Maltese: Nasym huwa vaċċin.