FrancophonIA/ELRC3.0 huggingface dataset:
English: The mechanism of the clarithromycin/atazanavir interaction is CYP3A4 inhibition.
Maltese: Il-mekkaniżmu ta' interazzjoni ta' clarithromycin/atazanavir huwa linibizzjoni ta' CYP3A4.
English: For co-administration of sildenafil for the treatment of erectile dysfunction see sections 4.4 and 4.5.
Maltese: Għal għoti flimkien ta' sildenafil għall-kura ta' disfunzjoni erettili, ara s-sezzjonijiet 4.4 u 4.5.
English: The mechanism of efavirenz/atazanavir interaction is CYP3A4 induction.
Maltese: Il-mekkaniżmu tal-interazzjoni ta' efavirenz/atazanavir huwa linduzzjoni ta' CYP3A4. ** Fuq il-bażi ta' paragun storiku.
English: Iron oxide yellow (E172) Iron oxide red (E172) Titanium dioxide (E171) Gelatin
Maltese: Iron oxide yellow (E172)
English: • oedema (swelling)
Maltese: • insonnja (diffikultà fl-irqad)
English: PVC/PVDC/Aluminium blisters containing 60, 60 x 1 (unit dose) capsules.
Maltese: Għal folji tal-PVC/PVDC/Aluminju li jkun fihom 60, 60 x 1 (doża waħda) kapsula.
English: eczema, vasodilatation
Maltese: ekżema, vażodilazzjoni
English: Atazanavir is metabolised and eliminated primarily by the liver.
Maltese: Atazanavir jiġi metabolizzat u eliminat prinċipalment mill-fwied.
English: Ethinyloestradiol Cmax ↑15% (↓1%
Maltese: Cmax ta' Ethinyloestradiol ↑15 %
English: Posology
Maltese:  LISTA
English: • ketoconazole, itraconazole, and voriconazole (antifungals)
Maltese: • ginektomastja (tkabbir tas-sider fl-irġiel)
English: Elbasvir AUC: ↑376% (↑307%
Maltese: ↑376% (↑307% Cmax ta' Elbasvir:
English: If the patient has developed SJS or DRESS associated with the use of atazanavir, atazanavir may not be restarted.
Maltese: Fil-maġġoranza tal-pazjenti, tnaqqis kemm fl-esponiment għal voriconazole u għal atazanavir huwa mistenni.
English: OPIOIDS
Maltese: Antiarritmiċi
English: 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 24 hour concentration following a high fat meal was increased by approximately 33% due to delayed absorption; the median Tmax increased from 2.0 to 5.0 hours.
Maltese: Il-konċentrazzjoni ta' 24 siegħa wara ikla b'ħafna xaħam żdiedet b'madwar 33% minħabba assorbiment imdewwem; it-Tmax medjan żdied minn 2.0 għal 5.0 sigħat.
English: Ten patients had baseline phenotypic resistance to atazanavir + ritonavir (fold change [FC]>5.2).
Maltese: b Għaxar pazjenti kellhom reżistenza fenotipika tal-linjabażi għal atazanavir + ritonavir (bidla tal-fold
English: • alopecia (unusual hair loss or thinning), pruritus (itching)
Maltese: • alopeċja (waqa' tax-xagħar mhux normali jew tħaffif tax-xagħar), prurite (ħakk)
English: Potential for increased alfuzosin concentrations which can result in hypotension.
Maltese: Passaġġi metaboliċi oħra huma N-dealkilazzjoni u idrolisi.
English: Two percent of patients treated with atazanavir experienced concurrent Grade 3-4 ALT/AST and Grade 3-4 total bilirubin elevations.
Maltese: Tnejn fil-mija tal-pazjenti taħt il-kura b'atazanavir kellhom fl-istess ħin ALT/AST Grad 3-4 u bilirubin totali ta' Grad 3-4 elevati.
English: PVC/PVDC/Aluminium blisters containing 30, 30 x 1 (unit dose) capsules.
Maltese: Għal folji tal-PVC/PVDC/Aluminju li jkun fihom 30, 30 x 1 (doża waħda) kapsula.
English: Alternative antiretroviral therapy to Atazanavir Mylan may be considered if jaundice or scleral icterus is unacceptable to a patient.
Maltese: It-tabib tiegħek jista' jbiddel id-doża ta' Atazanavir Mylan skont it-terapija ta' kontra lHIV li qed tieħu.
English: Atazanavir concentrations were greatly decreased when co-administered 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: Atazanavir Cmin ↓65% (↓71%
Maltese: AUC ta' Atazanavir ↓61% (↓65% Cmax ta' Atazanavir ↓66% (↓62% Cmin ta' Atazanavir ↓65% (↓71%
English: Concomitant use of St. John's wort with atazanavir may be expected to result in significant reduction in plasma levels of atazanavir.
Maltese: John's wort ma' atazanavir jista' jkun mistenni li jirriżulta fi tnaqqis sinifikanti fil-livelli ta' atazanavir fil-plażma.
English: Nephrolithiasis has been reported in patients receiving atazanavir (see section 4.8).
Maltese: Nefrolitjażi ġiet irrapportata f'pazjenti li kienu qed jirċievu atazanavir (ara sezzjoni 4.8).
English: Co-administration of atazanavir 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: L-għoti flimkien ta' atazanavir 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: Tacrolimus
Maltese: KORTIKOSTEROJDI
English: Also see PULMONARY ARTERIAL HYPERTENSION in this table for further information regarding coadministration of atazanavir with sildenafil.
Maltese: Ara wkoll PRESSJONI GĦOLJA ARTERJALI PULMONARI f'din it-tabella għal aktar informazzjoni dwar l-għoti fl-istess ħin ta' atazanavir u sildenafil.
English: This medicine comes in blister packs containing 30, 60 or 60 x 1 (unit dose) capsules or in bottles containing 60 hard capsules.
Maltese: Din il-mediċina tiġi f'pakketti bil-folji li jkun fihom 30, 60 jew 60 x 1 (doża waħda) kapsula jew fi fliexken li jkun fihom 60 kapsula iebsa.
English: When atazanavir 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 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 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 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: 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: atazanavir 400 mg without ritonavir (n=28).
Maltese: Raltegravir 400 mg darbtejn kuljum (atazanavir/ritonavir)
English: ANTI-HCV AGENTS Grazoprevir 200 mg once daily (atazanavir 300 mg / ritonavir 100 mg once daily)
Maltese: Fluconazole 200 mg darba kuljum (atazanavir 300 mg u ritonavir 100 mg darba kuljum)
English: Among experienced patients treated with atazanavir 300 mg once daily with 100 mg ritonavir once daily for a median duration of 95 weeks, 53% had Grade 3-4 total bilirubin elevations.
Maltese: Fost il-pazjenti li kienu rċevew il-kura, ikkurati b'atazanavir 300 mg darba kuljum ma' 100 mg ritonavir darba kuljum għal żmien medju ta' 95 ġimgħa, 53% kellhom żidiet totali ta' bilirubin ta' Grad 3-4.
English: Tenofovir disoproxil fumarate 300 mg once daily
Maltese: Tenofovir disoproxil fumarate 300 mg darba kuljum (atazanavir 300 mg darba kuljum ma' ritonavir 100 mg darba kuljum)
English: Metabolic parameters Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4).
Maltese: Il-piż u l-livelli ta' lipidi u glukożju fid-demm jistgħu jiżdiedu matul it-terapija antiretrovirali (ara sezzjoni 4.4).
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: B'dożi għoljin li jwasslu għal riskju għoli għall-mediċina, ġiet innotata suffejra minħabba iperbilirubinemja indiretta (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: HORMONAL CONTRACEPTIVES Ethinyloestradiol 25 μg + norgestimate
Maltese: Ethinyloestradiol 25 μg + norgestimate (atazanavir 300 mg darba kuljum ma' ritonavir 100 mg darba kuljum)
English: Atazanavir Mylan 300 mg hard capsules
Maltese: Atazanavir Mylan 300 mg kapsuli ibsin
English: 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'
English: • weight decreased, weight gain, anorexia (loss of appetite), appetite increased
Maltese: • tnaqqis fil-piż, żieda fil-piż, anoreksja (telf ta' l-aptit), żieda fl-aptit
English: f)
Maltese: NN:
English: The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
Maltese: It-tul tat-terapija antiretrovirali mħallta, użu ta' corticosteroid, konsum ta' alkoħol, immunosoppressjoni gravi, indiċi tal-massa tal-ġisem ogħla, fost oħrajn, jistgħu jkunu xi wħud millħafna fatturi ta' riskju għall-iżvillup ta' din il-marda.
English: * When compared to atazanavir 300 mg once daily with ritonavir 100 mg once daily and tenofovir disoproxil fumarate 300 mg all as a single dose with food.
Maltese: * Meta mqabbel ma' atazanavir 300 mg darba kuljum ma' ritonavir 100 mg darba kuljum u tenofovir disoproxil fumarate 300 mg kollha bħala doża waħda mal-ikel.
English: Voriconazole Cmin ↑765% (↑571%
Maltese: AUC ta' Voriconazole ↑561% Cmax ta' Voriconazole ↑438% Cmin ta' Voriconazole ↑765%
English: The recommended standard treatment is atazanavir boosted with ritonavir, ensuring optimal pharmacokinetic parameters and level of virologic suppression.
Maltese: Il-kura standard rakkomandata hija atazanavir imsaħħaħ b'ritonavir, li din tiżgura l-aqwa parametri farmakokinetiċi u livell ta' soppressjoni viroloġika.
English: Co-administration with atazanavir with ritonavir warrants clinical monitoring for sedation and cognitive effects.
Maltese: Hija meħtieġa l-kawtela u huwa rakkomandat monitoraġġ talkonċentrazzjoni terapewtika meta disponibbli.
English: • disorientation, amnesia (loss of memory), dizziness, somnolence (sleepiness), abnormal dream
Maltese: • disorjentazzjoni, amnesija (telf ta' memorja), sturdament, ngħas (ħelda), ħolm mhux normali
English: Buprenorphine Cmax ↑37%
Maltese: AUC ta' Buprenorphine ↑67% Cmax ta' Buprenorphine ↑37% Cmin ta' Buprenorphine ↑69%
English: 30 hard capsules.
Maltese: FARMAĊEWTIKA U KONTENUT 30 kapsula iebsa.
English: ANTIFUNGALS Ketoconazole 200 mg once daily
Maltese: ANTIFUNGALI Ketoconazole 200 mg darba kuljum (atazanavir 400 mg darba kuljum)
English: Desacetyl-diltiazem AUC ↑165%
Maltese: AUC ta' Norgestimate ↑85%
English: Efficacy data observed in the 41 paediatric patients aged 6 years to less than 18 years that received Atazanavir capsules with ritonavir are presented in Table 7.
Maltese: Dejta dwar effikaċja osservata fil-41 pazjent pedjatriku li kellhom minn 6 snin sa mhux aktar minn 18il sena li ħadu l-kapsuli ta' atazanavir hi ppreżentata f'Tabella 7.
English: • salmeterol (used to treat asthma)
Maltese: • għeja (għeja tremenda)
English: atazanavir Cmax ↓ 25%
Maltese: AUC ta' Atazanavir ↓35% Cmax ta' Atazanavir ↓25% Cmin ta' Atazanavir ↓49%
English: Atazanavir Mylan 150 mg hard capsules Atazanavir Mylan 200 mg hard capsules Atazanavir Mylan 300 mg hard capsules
Maltese: Atazanavir Mylan 200 mg kapsuli ibsin atazanavir  DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: Atazanavir Mylan 150 mg hard capsules atazanavir
Maltese: TAL-PRODOTT MEDIĊINALI Atazanavir Mylan 150 mg kapsuli ibsin. atazanavir
English: The study assessed 40 infants who received antiretroviral prophylactic treatment (which did not include atazanavir) and were negative for HIV-1 DNA at the time of delivery and/or during the first 6 months postpartum.
Maltese: L-istudju vvaluta 40 tarbija li rċevew kura profilattika antiretrovirali (li ma kinitx tinkludi atazanavir) u kienu negattivi għal HIV-1 DNA fil-ħin tal-għoti u/jew matul l-ewwel 6 xhur wara t-twelid.
English: EU/1/16/1091/004 EU/1/16/1091/005 EU/1/16/1091/013 EU/1/16/1091/014 EU/1/16/1091/015
Maltese: EU/1/16/1091/005 EU/1/16/1091/013 EU/1/16/1091/014
English: (range: 100 to 1157 cells/ mm 3) 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: Number of patients with paired genotypes classified as virological failures (HIV RNA ≥ 400 copies/ml).
Maltese: 10-20% ħadd a Numru ta' pazjenti b'ġenotipi ffurmati bħala pari kklasifikati bħala fallimenti virloġikali (HIV RNA ≥400 kopji/ml).
English: Co-administration of voriconazole and Atazanavir Mylan with ritonavir is not recommended, unless an assessment of the benefit/risk justifies the use of voriconazole.
Maltese: L-għoti fl-istess ħin ta' voriconazole u Atazanavir Mylan ma' ritonavir mhuwiex rakkomandat sakemm stima tal-benefiċċji/riskji ma tkunx tiġġustifika l-użu ta' voriconazole.
English: ACID REDUCING AGENTS H2-Receptor antagonists
Maltese: Antagonisti tar-Riċettur H2
English: Each capsule contains 150 mg atazanavir (as sulphate)
Maltese: Kull kapsula fiha 150 mg atazanavir (bħala sulfat). 200 mg kapsuli
English: None of the de novo substitutions (see Table 4) are specific to atazanavir and may reflect re-emergence of archived resistance on atazanavir + ritonavir in Study 045 treatment-experienced population.
Maltese: Sostituzzjonijiet De novo f'pazjenti li kienu għaddew minn kura li fallew it-terapija b'atazanavir + ritonavir (Studji 045, 48 ġimgħa)
English: While it may contribute to decreased susceptibility to atazanavir when it occurs with other protease substitutions, in clinical studies N88S by itself does not always lead to phenotypic resistance to atazanavir or have a consistent impact on clinical efficacy.
Maltese: Filwaqt li din tista' tikkontribiwxxi għal suxxettibbiltà mnaqqsa għal atazanavir meta jseħħ ma' sostituzzjonijiet ta' protease oħrajn, fi studji kliniċi, N88S waħdu ma jwassalx dejjem għal reżistenza fenotipika għal atazanavir jew ikollu impatt konsistenti fuq l-effikaċja klinika.
English: Mean urinary excretion of unchanged drug was 7% following 2 weeks of dosing at 800 mg once daily.
Maltese: Il-medja ta' mediċina mhux mibdula li ħarġet fl-urina kienet ta' 7% wara ġimagħtejn li ngħatat doża ta' 800 mg darba kuljum.
English: Co-administration of Atazanavir Mylan with nevirapine or efavirenz is not recommended (see section 4.5).
Maltese: L-għoti fl-istess ħin ta' nevirapine u atazanavir mhuwiex rakkomandat (ara sezzjoni 4.4)
English: • 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: - l-għoti flimkien ta' voriconazole u atazanavir mingħajr ritonavir jista' jaffettwa lkonċentrazzjonijiet ta' atazanavir - l-għoti flimkien ta' fluticasone u atazanavir mingħajr ritonavir jista' jżid ilkonċentrazzjonijiet ta' fluticasone meta mqabbla ma' fluticasone mogħti waħdu, - jekk ma' atazanavir mingħajr ritonavir jingħata kontraċettiv orali, huwa rakkomandat li lkontraċettiv orali ma jkunx fih aktar minn 30 µg ta' ethinyloestradiol - ma hemmx bżonn aġġustament fid-doża ta' lamotrigine
English: In pregnant rabbits, gross lesions of the stomach and intestines were observed in dead or moribund does at maternal doses 2 and 4 times the highest dose administered in the definitive embryo-development study.
Maltese: Fil-fniek tqal ġew osservati leżjonijiet imdaqqsin fl-istonku u fl-intestini tal-fenka mejta jew moribonda b'dożi materni darbtejn u 4 darbiet l-ogħla doża amministrata waqt l-istudju dwar l-iżvilupp definittiv ta' l-embriju.
English: Atazanavir Cmax ↑18% (↑6.7%
Maltese: AUC ta' Atazanavir ↑18% (↑6.5% Cmax ta' Atazanavir ↑18% (↑6.7% Cmin ta' Atazanavir ↑24% (↑10%
English: Co- administration of atazanavir /ritonavir and these glucocorticoids is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.4).
Maltese: L-għoti fl-istess ħin ta' atazanavir/ritonavir u dawn ilglukokortikojdi mhuwiex rakkomandat sakemm il-benefiċċju potenzjali tal-kura ma jkunx jiżboq ir-riskju ta' effetti sistemiċi millkortikosterojdi (ara sezzjoni 4.4).
English: Atazanavir Mylan 150 mg capsules are greenish-blue and blue opaque hard shell gelatin capsules filled with white to pale yellow powder and approximately 19.3 mm in length.
Maltese:  INFORMAZZJONI BIL-BRAILLE Atazanavir Mylan 150 mg kapsuli ibsin  IDENTIFIKATUR UNIKU - BARCODE 2D Barcode 2D li jkollu l-identifikatur uniku inkluż.  IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM PC:
English: Co-administration of voriconazole and atazanavir with ritonavir is not recommended unless an assessment of the benefit/risk to the patient justifies the use of voriconazole (see section 4.4).
Maltese: L-għoti fl-istess ħin ta' voriconazole u atazanavir ma' ritonavir mhuwiex rakkomandat sakemm valutazzjoni talbenefiċċju/riskju għall-pazjent ma tiġġustifikax l-użu ta' voriconazole (ara sezzjoni 4.4).
English: United Kingdom
Maltese: Deutschland
English: Atazanavir Mylan 200 mg capsules are blue and greenish-blue opaque hard shell gelatin capsules filled with white to pale yellow powder and approximately 21.4 mm in length.
Maltese: Atazanavir Mylan 200 mg kapsuli huma kapsuli tal-ġelatina ta' lewn blu u aħdar-blu, b'qoxra iebsa opaka mimlija bi trab minn abjad sa isfar ċar, u fihom tul ta' madwar 21.4 mm.
English: Atazanavir is expected to increase plasma levels of lurasidone due to CYP3A4 inhibition.
Maltese: Atazanavir huwa mistenni li jżid illivelli ta' lurasidone fil-plażma minħabba inibizzjoni ta' CYP3A4.
English: Immune reactivation syndrome
Maltese: Sindrome ta' riattivazzjoni ta' l-immunità
English: HIV RNA <50 copies/ml by select baseline PI substitutions,
Maltese: HIV RNA <50 kopja/ml, %f (min rrisponda/evalwabbli) Il-pazjenti kollha
English: (300 mg/100 mg once daily) n=440
Maltese: Atazanavir/ritonavirb (300 mg/100 mg darba kuljum) n=440
English: Pregnancy
Maltese: AGONISTI
English: 3) and the mean baseline plasma HIV-1 RNA level was 4.4 log10 copies/ml (range: 2.6 to 5.88 log10 copies/ml).
Maltese: NA a 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: Atazanavir Cmax ↓20% (↓32% ↓7%)
Maltese: AUC ta' Atazanavir ↓18% (↓25% Cmax ta' Atazanavir ↓20% (↓32% Cmin ta' Atazanavir ↔1% (↓16%
English: EMA/601036/2014 EMEA/H/C/002569
Maltese: EMEA/H/C/002569
English: The full EPAR and risk management plan summary for Vargatef can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom cycle, Vargatef is given on days 2 to 21 with docetaxel being given on day 1.
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom minn xulxin).
English: Vargatef contains the active substance nintedanib.
Maltese: Vargatef fih is-sustanza attiva nintedanib.
English: Vargatef is available as capsules (100 and 150 mg) to be taken by mouth, preferably with food.
Maltese: Vargatef huwa disponibbli bħala kapsuli (100 u 150 mg) biex jittieħdu mill-ħalq, preferibbilment malikel.
English: Other information about Vargatef
Maltese: Informazzjoni oħra dwar Vargatef
English: This is a summary of the European public assessment report (EPAR) for Vargatef.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Vargatef.
English: The active substance in Vargatef, nintedanib, blocks the activity of some enzymes known as tyrosine kinases.
Maltese: Is-sustanza attiva f'Vargatef, in-nintedanib, timbblokka l-attività ta' xi enzimi magħrufin bħala kinażi tat-tirosina.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vargatef on 21 November 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Vargatef fil-21 ta' Novembru 2014.
English: What are the risks associated with Vargatef?
Maltese: X'inhuma r-riskji assoċjati ma' Vargatef?
English: If severe side effects persist, treatment should be permanently discontinued.
Maltese: Jekk effetti sekondarji jippersistu, il-kura għandha titwaqqaf b'mod permanenti.
English: This summary was last updated in 11-2014.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'11-2014.
English: Progression-free survival (the time patients lived without their disease getting worse) was 3.5 months in patients receiving Vargatef plus docetaxel, compared with 2.7 months in patients receiving docetaxel alone.
Maltese: Sopravivenza mingħajr progressjoni (iż-żmien li l-pazjenti għexu mingħajr ma tiggravalom il-marda) kien 3.5 xhur f'pazjenti li rċevew Vargatef flimkien ma' docetaxel, meta mqabbel ma' 2.7 xhur f'pazjenti li rċevew docetaxel waħdu.
English: A risk management plan has been developed to ensure that Vargatef is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Vargatef jintuża bl-aktar mod sigur possibbli.
English: Why is Vargatef approved?
Maltese: Għaliex ġie approvat Vargatef?
English: In a main study involving 1,314 patients with advanced or recurrent non-small cell lung cancer that did not respond to a previous treatment, Vargatef taken in combination with docetaxel was shown to be more effective than docetaxel alone at delaying progression of the cancer.
Maltese: Fi studju ewlieni li involva 1,314 pazjenti b'kanċer tal-pulmun avvanzat jew rikorrenti mhux taċ-ċelloli żgħar li ma rrispondewx għal kura preċedenti, Vargatef meħud flimkien ma' docetaxel intwera li huwa aktar effettiv minn docetaxel waħdu fid-dewmien tal-progressjoni tal-kanċer.
English: In addition, Vargatef led to an improvement in overall survival (how long patients lived) in the subgroup of patients with non-small cell lung cancer of the adenocarcinoma type: overall survival was 12.6 months in patients treated with Vargatef plus docetaxel, compared with 10.3 months in patients treated with docetaxel alone.
Maltese: Barra minn hekk, Vargatef wassal għal titjib fis-sopravvivenza ġenerali (kemm damu ħajjin ilpazjenti) fis-sottogrupp ta' pazjenti b'kanċer tal-pulmun mhux taċ-ċelloli żgħar tat-tip adenokarċinoma: is-sopravvivenza totali kienet ta' 12.6 xhur f'pazjenti kkurati b'Vargatef flimkien ma' docetaxel, meta mqabbel ma' 10.3 xhur f'pazjenti kkurati b'docetaxel waħdu.