FrancophonIA/ELRC3.0 huggingface dataset:
English: Renal impairment Results from a mass balance study with
Maltese: Indeboliment renali Riżultati minn studju ta' bilanċ tal-massa b'
English: Postpartum (6-12 weeks) (n=16)
Maltese: Wara t-twelid (6 ġimgħat-12-il ġim għa) (n=16)
English: Darunavir/ritonavir 800/100 mg once daily in ART-experienced patients should not be used in patients with one or more darunavir resistance associated mutations (DRV-RAMs) or HIV-1 RNA ≥ 100,000 copies/ml or CD4+ cell count < 100 cells x 10
Maltese: Darunavir/ritonavir 800/100 mg darba kuljum f'pazjenti li diġà ħadu ART m'għandux jintuża f'pazjenti b'mutazzjoni waħda jew aktar assoċjati ma' reżistenza għal darunavir (DRV-RAMs) jew HIV-1 RNA ≥ 100,000 kopja/ml jew għadd ta' ċelluli CD4+ < 100 ċelluli x 106/l (ara sezzjoni 4.2 u 4.4).
English: Musculoskeletal and connective tissue disorders common myalgia uncommon osteonecrosis*
Maltese: Disturbi fis-sistema immuni komuni mhux komuni sensittività eċċessiva (għall-mediċina)
English: Darunavir boosted with cobicistat is more sensitive for CYP3A induction: concomitant use of darunavir/cobicistat and strong CYP3A inducers is therefore contraindicated (see section 4.3),and concomitant use with weak to moderate CYP3A inducers is not recommended (see section 4.5).
Maltese: - Darunavir intensifikat b'cobicistat huwa aktar sensittiv għal induzzjoni minn CYP3A: għalhekk l-użu ta' darunavir/cobicistat flimkien ma' indutturi qawwija ta' CYP3A huwa kontraindikat (ara sezzjoni 4.3), u l-użu flimken ma' indutturi ħfief sa moderati ta' CYP3A mhuwiex irrakkomandat (ara sezzjoni 4.5).
English: There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthrosis in patients with haemophilia type A and B treated with PIs.
Maltese: Kien hemm rapporti ta' żieda fil-fsada, inkluż ematomi spontanji fil-ġilda u emartrożi f'pazjenti bl-emofilja tat-tip A u B trattati bl-Impedituri ta' Protease.
English: Third Trimester of pregnancy (n=15)
Maltese: It-tielet trimestru tat-tqala (n=15)
English: Darunavir co-administered with low dose ritonavir can be expected to increase the plasma concentrations of calcium channel blockers.
Maltese: Darunavir intensifikat jista' jkun mistenni li jżid il-konċentrazzjonijiet ta' imblokkaturi tal-kanali tal-kalċju fil-plażma.
English: The below list of examples of drug drug interactions is not comprehensive and therefore the label of each drug that is co-administered with darunavir should be consulted for information related to the route of metabolism, interaction pathways, potential risks, and specific actions to be taken with regards to co-administration.
Maltese: Il-lista t'hawn taħt ta' eżempji ta' interazzjonijiet bejn mediċina u oħra mhijiex komprensiva u għalhekk it-tikketta ta' kull mediċina li tittieħed flimkien ma' darunavir għandha tiġi kkonsultata għal informazzjoni marbuta mar-rotta ta' metaboliżmu, is-sensiela ta' reazzjonijiet ta' interazzjoni, riskji possibbli, u azzjonijiet speċifiċi li għandhom jittieħdu dwar l-għoti tagħhom flimkien.
English: The observed hepatocellular and thyroid tumours in rodents are considered to be of limited relevance to humans.
Maltese: It-tumuri epatoċellulari u tat-tirojde li ġew osservati fl-annimali gerriema huma kkunsidrati ta' rilevanza limitata għallbnedmin.
English: Each film-coated tablet contains 600 mg darunavir.
Maltese: Kull pillola miksija b'rita fiha 600 mg darunavir.
English: ART-experienced adult patients The recommended dose regimens are as follows: In ART-experienced patients with no darunavir resistance associated mutations (DRV-RAMs)* and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 10 6/l
Maltese: L-iskedi ta' għoti tad-dożi rrakkomandati huma kif ġej: - Għal adulti li jkunu diġà ħadu kura b'ART qabel mingħajr reżistenza għal darunavir assoċjata ma' mutazzjonijiet (DRV-RAMs)* u li għandhom < 100,000 kopja/ml ta' HIV-1 RNA u għadd ta' ċelluli CD4+ ≥ 100 ċellula x 106/l fil-plażma (ara sezzjoni 4.1), tista' tintuża l-iskeda ta' għoti ta' dożi ta' 800 mg darba kuljum ma' ritonavir 100 mg darba kuljum mal-ikel.
English: EU/1/17/1249/005 30 film-coated tablets EU/1/17/1249/006 60 film-coated tablets EU/1/17/1249/007 90 film-coated tablets EU/1/17/1249/008 180 film-coated tablets
Maltese: EU/1/17/1249/006 90 pillola miksijin b'rita:
English: Therefore, darunavir must not be used in patients with severe hepatic impairment (Child-Pugh Class C) (see sections 4.3, 4.4 and 5.2).
Maltese: Għalhekk, darunavir m'għandux jintuża f'pazjenti b'indeboliment epatiku serju (Child-Pugh Klassi Ċ) (ara sezzjonijiet 4.3, 4.4 u 5.2).
English: Darunavir Krka 600 mg tablets may be used to provide suitable dose regimens (see section 4.2): For the treatment of HIV-1 infection in antiretroviral treatment (ART)-experienced adult patients, including those that have been highly pre-treated.
Maltese: Il-pilloli Darunavir Krka 600 mg jistgħu jintużaw biex jipprovdu skedi ta' għoti ta' dożi xierqa (ara sezzjoni 4.2): - Għall-kura tal-infezzjoni tal-HIV f'pazjenti adulti li diġà ħadu kura b'antiretrovirali (ART), inkluż dawk li qabel kienu diġà ġew ikkurati ħafna.
English: median CD4+ cell count change from baseline (x 10
Maltese: Medja ta' tibdil fl-għadd taċ-ċelluli CD4+ millinja bażi (x 10
English: EU/1/17/1249/001 30 film-coated tablets EU/1/17/1249/002 60 film-coated tablets EU/1/17/1249/003 90 film-coated tablets EU/1/17/1249/004 180 film-coated tablets
Maltese: EU/1/17/1249/001 60 pillola miksijin b'rita:
English: ART-naïve paediatric patients from the age of 12 years to < 18 years, and weighing at least 40 kg DIONE is an open-label, Phase II trial evaluating the pharmacokinetics, safety, tolerability, and efficacy of darunavir with low dose ritonavir in 12 ART-naïve HIV-1 infected paediatric patients aged 12 to less than 18 years and weighing at least 40 kg.
Maltese: II b'tikketta tingħaraf li evalwat il-farmakokinetiċi, issigurtà, it-tolerabilità u l-effikaċja ta' darunavir ma' doża baxxa ta' ritonavir fi 12-il pazjent infettat b'HIV-1 li ma ġiex ikkurat b'ART u li kellhom minn 12 sa inqas minn 18-il-sena u li kienu jiżnu inqas minn 40 kg.
English: cobicistat.
Maltese: klinika.
English: HIV-1 RNA < 50 copies/ml CD4+ percent change from baseline CD4+ cell count mean change from baseline ≥ 1.0 log10 decrease from baseline in plasma viral load
Maltese: CD4+ bidla perċentwali mil-linja bażi ta' riferiment CD4+ bidla medja fl-għadd ta' ċelluli mil-linja bażi ≥ 1.0 log10 tnaqqis mil-linja bażi fit-tagħbija virali filplażma
English: Concomitant use of bosentan and boosted darunavir may increase plasma concentrations of bosentan.
Maltese: L-użu komkomitanti ta' bosentan u darunavir intensifikat jista' jżid il-konċentrazzjonijiet ta' bosentan fil-plażma.
English: 600 milligram darunavir + 100 milligram ritonavir twice a day * For children aged 12 or more and weighing at least 40 kilograms, your child's doctor will determine if Darunavir
Maltese: 600 milligramma darunavir + 100 milligramma ritonavir darbtejn kuljum *Għal tfal ta' 12-il sena jew aktar u li jiżnu tal-anqas 40 kilogramma, it-tabib tattifel jew tifla tiegħek ser jistabilixxi jekk tistax tintuża d-doża ta' Darunavir Krka 800 milligramma darba kuljum.
English: Third trimester of pregnancy (n=6)
Maltese: It-tielet trimestru tat-tqala (n=6)
English: For the treatment of pulmonary arterial hypertension Sildenafil
Maltese: Parametri tal-piż u metaboliċi
English: If parenteral midazolam is coadministered with darunavir with low dose ritonavir, 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: Jekk midazolam parenterali jingħata flimkien ma' darunavir intensifikat, dan għandu jsir f'qasam tal-kura intensiva (ICUintensive care unit) jew post jixbhu, li jiżgura sorveljanza klinika mill-qrib u immaniġġar mediku xieraq f'każ ta' depressjoni respiratorja u/jew sedazzjoni fit-tul.
English: 30 film-coated tablets 60 film-coated tablets 90 film-coated tablets 180 film-coated tablets
Maltese: 30 pillola miksijin b'rita 60 pillola miksijin b'rita 90 pillola miksijin b'rita 180 pillola miksijin b'rita
English: Therefore, darunavir must only be used in combination with low dose ritonavir as a pharmacokinetic enhancer (see sections 4.4 and 5.2).
Maltese: Ma hemm bżonn l-ebda aġġustament tad-doża f'pazjenti b'indeboliment renali serju (ara sezzjonijiet 4.4 u 5.2).
English: Co-administration of darunavir and ritonavir with medicinal products which are primarily metabolised by CYP2D6 (such as flecainide, propafenone, metoprolol) may result in increased plasma concentrations of these medicinal products, which could increase or prolong their therapeutic effect and adverse reactions.
Maltese: L-amministrazzjoni ta' darunavir u ritonavir flimkien ma' prodotti mediċinali li huma primarjament immetabolizzati minn CYP2D6 (bħal flecainide, propafenone, metoprolol) tista' twassal għal żieda ta' konċentrazzjonjiet fil-plażma ta' dawn il-prodotti mediċinali, li jistgħu jżidu jew itawwlu l-effett terapewtiku tagħhom u r-reazzjonijiet avversi.
English: For clinical trial results in ART-naïve adult patients, refer to the Summary of Product Characteristics for Darunavir Krka 400 mg and 800 mg tablets.
Maltese: Għal riżultati minn provi kliniċi f'pazjenti adulti li qatt ma ħadu kura b'ART qabel, irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott ta' Darunavir Krka pilloli ta' 400 mg u 800 mg.
English: C-darunavir trial in healthy volunteers showed that a majority of the radioactivity in plasma after a single 400/100 mg darunavir with ritonavir dose was due to the parent active substance.
Maltese: C-darunavir f'voluntiera b'saħħithom uriet li l-maġġoranza ta' radjuattività fil-plażma wara doża waħda ta' 400/100 mg darunavir ma' ritonavir kienet minħabba s-sustanza attiva oriġinali.
English: Tell your doctor if you have had problems with your liver before, including hepatitis B or C infection.
Maltese: - Għid lit-tabib tiegħek jekk fil-passat kellek problemi bil-fwied,inkluż infezzjoni tal-epatite B jew Ċ.
English: In the 96 week analysis, the safety profile of darunavir/ritonavir 800/100 mg once daily in treatmentnaïve subjects was similar to that seen with darunavir/ritonavir 600/100 mg twice daily in treatmentexperienced subjects except for nausea which was observed more frequently in treatment-naïve subjects.
Maltese: Fis-96 ġimgħa ta' analiżi, il-profil ta' sigurtà ta' darunavir/ritonavir 800/100 mg darba kuljum f'individwi li qatt ma ħadu kura qabel kien jixbah lil dak li jidher b'darunavir/ritonavir 600/100 mg darbtejn kuljum f'pazjenti li jkunu diġà ħadu kura qabel minbarra t-tqalligħ li kien osservat aktar frekwenti f'individwi li qatt ma kienu ħadu kura qabel.
English: The clinical trial data from ART-experienced patients (TITAN trial and the pooled analysis of the POWER 1, 2 and 3 and DUET 1 and 2 trials) showed that virologic response to darunavir coadministered with low dose ritonavir was decreased when 3 or more darunavir RAMs (V11I, V32I, L33F, I47V, I50V, I54L or M, T74P, L76V, I84V and L89V) were present at baseline or when these mutations developed during treatment.
Maltese: Numru ta' tibdiliet ġenetiċi mil-lista ta' tibdiliet ġenetiċi assoċjati ma' nuqqas ta' rispons għalldarunavir/ritonavir (V11I, V32I, L33F, I47V, I50V, I54L jew M, T74P, L76V, I84V jew L89V) drabi ta' bidla fl-EC “Pazjenti li ma użawx ENF jew li użaw ENF qabel” huma pazjenti li ma użawx ENF jew li użaw ENF iżda mhux għall-ewwel darba “Pazjenti li qatt ma użaw ENF” huma pazjenti li użaw ENF għall-ewwel darba
English: Instructions for adults
Maltese: Istruzzjonijiet għall-adulti.
English: KRKA Farmacéutica, S.L.
Maltese: KRKA Pharma Dublin, Ltd.
English: In contrast to these data with darunavir /ritonavir, darunavir/cobicistat may increase these antidepressant plasma concentrations (CYP2D6 and/or CYP3A inhibition).
Maltese: B'kuntrast ma' din id-dejta għal darunavir/ritonavir, darunavir/cobicistat jista' jżid il-konċentrazzjonijiet ta' dawn l-antidepressanti fil-plażma (inibizzjoni ta' CYP2D6 u/jew CYP3A).
English: Vardenafil darunavir and low dose ritonavir.
Maltese: darunavir/ritonavir.
English: Darunavir Krka is available in bottles containing 30 film-coated tablets (1 bottle of 30 film-coated tablets), 60 film-coated tablets (2 bottles of 30 film-coated tablets), 90 film-coated tablets (3 bottles of 30 film-coated tablets) and 180 film-coated tablets (6 bottles of 30 film-coated tablets) in a boxes.
Maltese: Darunavir Krka pilloli miksijin b'rita huma disponibbli fi fliexken li fihom 30 pillola miksijin b'rita (flixkun 1 ta' 30 pillola miksijin b'rita), 60 pillola miksijin b'rita (2 fliexken ta' 30 pillola miksjin b'rita), 90 pillola miksijin b'rita (3 fliexken ta' 30 pillola miksjin b'rita) u 180 pillola miksijin b'rita (6 fliexken ta' 30 pillola miksjin b'rita) f'kaxxa.
English: Apixaban, edoxaban, rivaroxaban, warfarin (to reduce clotting of the blood) as their therapeutic effect or side effects may be altered; your doctor may have to check your blood.
Maltese: - Apixaban, edoxaban, rivaroxaban, warfarin(biex id-demmma jikkoagulax) minħabba li l-effett terapewtiku jew l-effetti sekondarji jistgħu jinbidlu; it-tabib tiegħek jista' jkun ikollu jiċċekkjalek id-demm.
English: Psychiatric disorders common abnormal dreams
Maltese: Għall-kura ta' anormalità erettili
English: Psychiatric disorders common insomnia uncommon depression, disorientation, anxiety, sleep disorder, abnormal dreams, nightmare, decreased libido rare confusional state, altered mood, restlessness
Maltese: Disturbi psikjatriċi komuni mhux komuni rari insomnja depressjoni, diżorjentament, ansjetà, disturb flirqad, ħolm mhux normali, ħmar il-lejl, tnaqqis fillibido,
English: Ergot alkaloids like ergotamine, dihydroergotamine, ergometrine and methylergonovine to treat migraine headaches
Maltese: Lurasidone, pimozide, quetiapine jew sertindolebiex tikkura kundizzjonijiet psikjatriċi Alkalojdi tal-ergot bħal ergotamine, dihydroergotamine, ergometrine u methylergonovine biex tikkura l-emigranja
English: Dose for children 3 years of age and above, weighing more than 40 kilograms who have not taken antiretroviral medicines before (your child's doctor will determine this) The usual dose of Darunavir Krka is 800 milligram (2 tablets containing 400 milligram of Darunavir Krka or 1 tablet containing 800 milligram of Darunavir Krka) together with 100 milligram ritonavir once daily.
Maltese: Doża għal tfal ta' 3 snin u aktar, li jiżnu tal-anqas 40 kilogramma li ma ħadux mediċini antiretrovirali qabel (it-tabib tal-tifel/tifla tiegħek ser jistabilixxi dan) - Id-doża rakkomandatatas-soltugħalDarunavir Krkahijata'800milligramma (2 pilloli li fihom 400 mg ta' Darunavir Krka jew pillola 1 li fiha 800 milligramma ta' Darunavir Krka) flimkien ma' 100 milligramma ritonavir darba kuljum.
English: Atazanavir: comparison of atazanavir/ritonavir 300/100 mg once daily vs. atazanavir 300 mg once daily in combination with darunavir/ritonavir 400/100 mg twice daily.
Maltese: Atazanavir: tqabbil ta' atazanavir/ritonavir 300/100 mg darba kuljum ma' atazanavir 300 mg darba kuljum flimkien ma' darunavir/ritonavir 400/100 mg darbtejn kuljum.
English: Each film-coated tablet contains 400 mg darunavir.
Maltese: Kull pillola miksija b'rita fiha 400 mg darunavir.
English: The frequency of this is unknown (see section 4.4).
Maltese: Il-prodott li fih lopinavir u ritonavir f'daqqa (ara sezzjoni 4.5).
English: Based on theoretical considerations boosted darunavir is expected to increase the exposure of lomitapide when coadministered.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi darunavir intensifikat huwa mistenni li jżid l-esponiment għal lomitapide meta
English: 800 milligram Darunavir Krka (2 tablets containing 400 milligram of Darunavir Krka or 1 tablet containing 800 milligram of Darunavir Krka) together with 100 milligram ritonavir once daily.
Maltese: JEW - 800 milligrammaDarunavir Krka(2 pilloli li fihom 400 milligrammata' Darunavir Krka jew pillola waħda li fiha 800 milligramma ta' Darunavir Krka) flimkien ma' 100 milligramma ritonavir darba kuljum.
English: ART-experienced paediatric patients from the age of 6 to < 18 years and weighing at least 20 kg DELPHI is an open-label, Phase II trial evaluating the pharmacokinetics, safety, tolerability, and efficacy of darunavir with low dose ritonavir in 80 ART-experienced HIV-1 infected paediatric patients aged 6 to 17 years and weighing at least 20 kg.
Maltese: DELPHI hija prova open-label tal-Fażi II li tevalwa l-farmakokinetika, is-sigurtà, it-tollerabilità u l-effikaċja ta' darunavir flimkien ma' doża baxxa ta' ritonavir fi 80 pazjent tifel/tifla infettati b'HIV-1 li diġà ħadu kura b'ART qabel li għandhom minn 6 snin sa17-il sena u li jiżnu mill-anqas 20 kg.
English: Other severe side effectswere diabetes (common) and inflammation of the pancreas (uncommon).
Maltese: Effetti sekondarji severi oħra kienu dijabete (komuni), u infjammazzjoni tal-frixa (mhux komuni).
English: The recommended dose regimen is 800 mg once daily with ritonavir 100 mg once daily taken with food.
Maltese: Effikaċja ta' darunavir 800 mg darba kuljum mogħti flimkien ma'100 mg ritonavir darba kuljum f'pazjenti li diġà ħadu ART.
English: 30 film-coated tablets 90 film-coated tablets
Maltese: 30 pillola miksijin b'rita 90 pillola miksijin b'rita
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer to the relevant product information for these medicinal products.
Maltese: F'każ ta' terapija antivirali konkomitanti għall-epatite B jew Ċ, jekk jogħġbok irreferi għall-informazzjoni rilevanti tal-prodott, għal dawn il-prodotti mediċinali.
English: Genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4.2, 4.4 and 5.1).
Maltese: It-tip ta' ikel ma jaffettwax l-esponiment għal darunavir (ara sezzjonijiet 4.4, 4.5 u 5.2).
English: The pharmacokinetics of darunavir in combination with ritonavir taken twice daily in 74 treatmentexperienced paediatric patients, aged 6 to 17 years and weighing at least 20 kg, showed that the administered weight-based doses of darunavir/ritonavir resulted in darunavir exposure comparable to that in adults receiving darunavir/ritonavir 600/100 mg twice daily (see section 4.2).
Maltese: Il-farmakokinetika ta' darunavir meta ngħata flimkien ma' ritonavir li ttieħed darbtejn kuljum f'74 pazjent tifel/tifla li kienu diġà ħadu kura qabel, li kellhom minn 6 snin sa 17-il sena u kienu jiżnu mill-anqas 20 kg, uriet li d-dożi ta' darunavir/ritonavir mogħtija skont il-piż irriżultaw f'esponiment għal darunavir li jaqbel ma' dak fl-adulti li kienu qed jirċievu darunavir/ritonavir 600/100 mg darbtejn kuljum (ara sezzjoni
English: Rare side effects (may affect up to 1 in 1,000 people) areaction called DRESS [severe rash, which may be accompanied by fever, fatigue, swelling of the face or lymph glands, increase of eosinophils (type of white blood cells), effects on liver, kidney or lung] heart attack, slow heart beating, palpitations visual disturbance chills, feeling abnormal a feeling of confusion or disorientation, altered mood, restlessness fainting, epileptic fits, changes or loss of taste mouth sores, vomiting blood, inflamation of the lips, dry lips, coated tongue running nose skin lesions, dry skin stiffness of muscles or joints, joint pain with or without inflammation changes in some values of your blood cells or chemistry.
Maltese: Effetti sekondarji rari (li jistgħu jaffettwaw persuna 1 f'1,000) - reazzjonilitissejjaħDRESS[raxxseverlijista'jkunakkumpanjatb'deni, għeja, nefħa tal-wiċċ jew glandoli limfatiċi, żieda ta' eosinofili (tip ta' ċelluli tad-demm bojod), effetti fuq il-fwied, il-kliewi jew il-pulmun] attakk tal-qalb, qalb tħabbat bil-mod, palpitazzjonijiet disturbi viżwali sirdat, tħossok mhux normali tħossok konfuż jew diżorjentat, bidla bil-burdata, irrikwitezza sturdament, attakki epilettiċi, bidliet jew telf fit-togħma postumetti, tirremetti d-demm, infjammazzjoni tax-xofftejn, xofftejn xotti, ilsien miksi imnieħer inixxi ġrieħi fil-ġilda, ġilda xotta ebusija tal-muskoli jew ġogi, uġigħ fil-ġog bi jew mingħajr infjammazzjoni - bidliet f'xi valuri taċ-ċelluli tad-demm jew kimika tiegħek.
English: OESTROGEN-BASED CONTRACEPTIVES Drospirenone
Maltese: KONTRAĊETTIVI BBAŻATI FUQ L-ESTROĠENU Drospirenone
English: This can be seen in a blood test. high blood pressure, flushing red or dry eyes fever, swelling of lower limbs due to fluids, malaise, irritability, pain symptoms of infection, herpes simplex erectile dysfunction, enlargement of breasts sleeping problems, sleepiness, depression, anxiety, abnormal dreams, decrease in sexual drive
Maltese: Din tista' tidher f'test tad-demm. pressjoni għolja, fwawar għajnejn ħomor jew xotti deni, nefħa fir-riġlejn minħabba fluwidi, telqa mingħajr sinjal ta' mard, irritabilità, uġigħ sintomi ta' infezzjoni, herpes simplex abnormalità erettili, tkabbir tas-sider - problemi bl-irqad, xejra ta' ngħas, depressjoni, ansjetà, ħolm mhux normali, tnaqqis fil-ġibda sesswali
English: The overall pharmacokinetic enhancement effect by ritonavir was an approximate 14-fold increase in the systemic exposure of darunavir when a single dose of 600 mg darunavir was given orally in combination with ritonavir at 100 mg twice daily (see section 4.4).
Maltese: L-effett ta' titjib farmakokinetiku totali permezz ta' ritonavir kien ta' żieda ta' bejn wieħed u ieħor 14-il darba fl-esponiment sistemiku ta' darunavir meta doża waħda ta' darunavir 600 mg ingħatat mill-ħalq flimkien ma' ritonavir f'doża ta' 100 mg darbtejn kuljum (ara sezzjoni 4.4).
English: Concomitant administration of boosted darunavir with dabigatran or ticagrelor is contraindicated (see section 4.3).
Maltese: L-għoti ta' darunavir intensifikat flimkien ma' dabigatran jew ticagrelor huwa kontraindikat (ara sezzjoni 4.3).
English: Darunavir: comparison of darunavir/ritonavir 400/100 mg twice daily vs. darunavir/ritonavir 400/100 mg twice daily in combination with atazanavir 300 mg once daily.
Maltese: Darunavir: tqabbil ta' darunavir/ritonavir 400/100 mg darbtejn kuljum ma' darunavir/ritonavir 400/100 mg darbtejn kuljum flimkien ma' atazanavir 300 mg darba kuljum.
English: The overall pharmacokinetic enhancement effect by ritonavir was an approximate 14-fold increase in the systemic exposure of darunavir when a single dose of 600 mg darunavir was given orally in combination with ritonavir at 100 mg twice daily.
Maltese: L-effett totali tal-intensifikazzjoni tal-effett farmakokinetiku permezz ta' ritonavir kien bejn wieħed u ieħor żieda ta' 14-il darba fl-esponimnet sistemiku ta' darunavir meta doża waħda ta' 600 mg darunavir ingħatat mill-ħalq flimkien ma' ritonavir 100 mg darbtejn kuljum.
English: Concentrate for solution for injection
Maltese: Konċentrat għal soluzzjoni għall-injezzjoni
English: Solution for injection
Maltese: Soluzzjoni għall-injezzjoni
English: 117 Allée des Parcs 69800 Saint-Priest France
Maltese: 117, Allée des Parcs 69800 Saint-Priest Franza
English: Severe hypotension (< 90/50 mm Hg).
Maltese: Ipotensjoni severa (< 90/50 mm Hg).
English: Stevens-Johnson Syndrome, Exfoliative dermatitis
Maltese: Sindromu ta' StevensJohnson, Dermatite esfoljattiva
English: INFORMATION IN BRAILLE Talmanco 20 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Talmanco 20 mg
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 09 January 2017
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 09 Jannar 2017
English: Oral contraceptive pill
Maltese: Il-Pillola kontraċettiva orali
English: The overall frequency of discontinuation due to adverse events was low (tadalafil 11%, placebo 16%).
Maltese: Il-frekwenza totali ta' twaqqif mill-kura minħabba avvenimenti avversi kien baxx (tadalafil 11%, plaċebo 16%).
English: Each film-coated tablet contains 237.9 mg lactose (234.5 mg as anhydrous and 3.4 mg as monohydrate).
Maltese: Kull pillola miksija b'rita fiha 237,9 mg lactose (234.5 mg bħala anhydrous u 3.4 mg bħala monohydrate).
English: Hypromellose (2910/15 mPa·s) (E464) Titanium dioxide (E171)
Maltese: Hypromellose (2910/15 mPa·s) (E464)