FrancophonIA/ELRC3.0 huggingface dataset:
English: Darunavir must always be given orally with low dose ritonavir as a pharmacokinetic enhancer and in combination with other antiretroviral medicinal products (see section 5.2).
Maltese: Darunavir għandu dejjem jingħata mill-ħalq flimkien ma' doża baxxa ta' ritonavir li jservi ta' intensifikatur farmakokinetiku u flimkien ma' prodotti mediċinali antiretrovirali oħra (ara sezzjoni 5.2).
English: At 48 weeks non-inferiority in virologic response to the darunavir/ritonavir treatment, defined as the percentage of patients with plasma HIV-1 RNA level < 400 and < 50 copies/ml, was demonstrated (at the pre-defined 12% non-inferiority margin) for both ITT and OP populations.
Maltese: Fit-48 ġimgħa in-nuqqas ta' inferjorità fir-rispons viroloġiku bi darunavir/ritonavir, definit bħala lperċentwal ta' pazjenti b'livell ta' < 400 kopja/ml u < 50 ta' HIV-1 RNA fil-plażma, intwera (filmarġini ta' 12% ddefinit minn qabel għan-nuqqas ta' inferjorità) kemm għal popolazzjonijiet ITT kif ukoll OP.
English: Viruses selected in these conditions and showing decreased susceptibility to darunavir (range: 23-50-fold) harboured 2 to 4 amino acid substitutions in the protease gene.
Maltese: Virusis magħżula f'dawn il-kundizzjonijiet u li urew suxxettibilità mnaqqsa darunavir (medda: 23-50 darba) kellhom fihom bejn 2 u 4 sostituzzjonijiet tal-aċidu amminiku fil-ġene protease.
English: Darunavir/ ritonavir 800/100 mg once daily N=294
Maltese: Darunavir/ ritonavir 800/100 mg darba kuljum N=294
English: Darunavir/cobicistat may, in contrast, increase methadone plasma concentrations (see cobicistat SmPC).
Maltese: B'kuntrast ma' dan, darunavir/cobicistat jista' iżid il-konċentrazzjonijiet ta' methadone fil-plażma (ara l-SmPC ta' cobicistat).
English: Polyvinyl alcohol, partially hydrolysed Titanium dioxide (E171) Macrogol
Maltese: Rita ta' barra tal-pillola Polyvinyl alcohol, parzjalment idrolizzat Titanium dioxide (E171) Macrogel
English: When used for birth control, alternative methods of non-hormonal contraception are recommended.
Maltese: Meta użati għall-kontroll tat-twelid, metodi alternattivi ta' kontraċezzjoni mhux ormonali huma rrakkomandati.
English: 6/l (see section 4.1) a regimen of 800 mg once daily with cobicistat 150 mg once daily or ritonavir 100 mg once daily taken with food may be used.
Maltese: 6/l (ara sezzjoni 4.1) skeda ta' 800 mg darba kuljum b'100 mg ritonavir darba kuljum mal-ikel tista' tiġi segwita.
English: 6/l (see section 4.2 and 4.4).
Maltese: 6/l (ara sezzjoni 4.2 u
English: Rifapentine and rifampicin are strong CYP3A inducers and have been shown to cause profound decreases in concentrations of other protease inhibitors, which can result in virological failure and resistance development (CYP450 enzyme induction).
Maltese: Rifapentine u rifampicin huma indutturi qawwija ta' CYP3A u ntwerew li jikkawżaw tnaqqis kbir filkonċentrazzjonijiet ta' impedituri ta' protease oħra, li jista' jwassal għal falliment viroloġiku u żvilupp ta' reżistenza (induzzjoni tal-enzima CYP450).
English: What Darunavir Mylan contains - The active substance is darunavir.
Maltese: X'fih Darunavir Mylan - Is-sustanza attiva hija darunavir.
English: Uncommon immune reconstitution inflammatory syndrome, (drug) hypersensitivity
Maltese: Disturbi fis-sistema immuni Komuni sensittività eċċessiva (għall-mediċina)
English: Domperidone
Maltese: Treddigħ
English: Blister carton 30 film-coated tablets 60 film-coated tablets 60 x 1 film-coated tablets
Maltese: Kartuna bil-folji 30 pillola miksija b'rita 60 pillola miksija b'rita 60 x 1 pillola miksija b'rita
English: If parenteral midazolam is coadministered with boosted darunavir it may cause a large increase in the concentration of this benzodiazepine.
Maltese: Jekk midazolam parenterali jingħata flimkien ma' darunavir intensifikat huwa jista' jikkawża żieda kbira filkonċentrazzjoni ta' dan il-benzodiazepine.
English: ART-experienced paediatric patients (3 to 17 years of age and weighing at least 40 kg) In ART-experienced patients without DRV-RAMs* and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 10
Maltese: Pazjenti pedjatriċi (3 snin sa 17-il sena u li ma jiżnux aktar minn 40 kg) b'esperjenza ta' ART F'pazjenti b'esperjenza ta' ART mingħajr DRV-RAMs* u li għandhom < 100,000 kopja/ml ta' HIV1/RNA fil-plażma u l-għadd ta' ċelluli ta' CD4+ ta' ≥ 100 ċellula x 10
English: Darunavir Mylan 800 mg film-coated tablets are available in blister packs containing 30 tablets and in plastic bottles containing 30, 60 and 90 tablets.
Maltese: Darunavir Mylan 800 mg pilloli miksija b'rita huma disponibbli f'pakketti b'folji li fihom 30 pillola u fi fliexken tal-plastik li fihom 30, 60 u 90 pillola.
English: The type of food does not affect the exposure to darunavir (see sections 4.4, 4.5 and 5.2).
Maltese: It-tip ta' ikel ma jaffettwax l-esponiment għal darunavir (ara sezzjonijiet 4.4, 4.5 u 5.2).
English: Darunavir Mylan must always be given orally with low dose ritonavir as a pharmacokinetic enhancer and in combination with other antiretroviral medicinal products.
Maltese: Darunavir Mylan għandu dejjem jingħata mill-ħalq flimkien ma doża baxxa ta' ritonavir li jservi ta' intensifikatur farmakokinetiku u flimkien ma' prodotti mediċinali antiretrovirali oħra.
English: ANTIEMETICS
Maltese: ANTIRETROVIRALI
English: Darunavir/ritonavir 600/100 mg twice daily + OBR N=298
Maltese: Darunavir/ritonavir 600/100 mg darbtejn kuljum + OBR N=298
English: OR - 600 milligram darunavir (2 tablets containing 300 milligram of darunavir or 1 tablet containing 600 milligram of darunavir) together with 100 milligram ritonavir twice daily.
Maltese: JEW - 600 milligramma darunavir (2 pilloli li fihom 300 milligramma ta' darunavir jew pillola waħda li fiha 600 milligramma ta' darunavir) flimkien ma' 100 milligramma ritonavir darbtejn kuljum.
English: Darunavir, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection (see section 4.2).
Maltese: Darunavir, mogħti flimkien ma' doża baxxa ta' ritonavir huwa indikat, flimkien ma' prodotti mediċinali antiretrovirali oħra, għall-kura ta' pazjenti b'infezzjoni bil-virus uman ta' limmunodefiċjenza (HIV-1) (ara sezzjoni 4.2).
English: CD4+ cell count mean change from baseline b
Maltese: CD4+ bidla perċentwali mil-linja bażi b
English: White to off-white, oval shaped, biconvex film-coated tablets approximately 9.7 mm by 4.6 mm, debossed with ‘M' on one side and ‘DV1' on the other side.
Maltese: Pilloli miksija b'rita bojod għal offwajt, b'forma ovali, imbuzzati fuq iż-żewġ naħat, ta' madwar 9.7 mm b'4.6 mm, imnaqqxa b'‘M' fuq naħa waħda u ‘DV1' fuq in-naħa l-oħra.
English: In the table below the specific pharmacokinetic enhancer is specified when recommendations differ.
Maltese: Fit-tabella taħt il-farmakointensifikatur speċifiku huwa speċifikat meta r-rakkomandazzjonijiet ikunu differenti.
English: Increasing baseline darunavir fold change in EC50 (FC) was associated with decreasing virologic response.
Maltese: Il-linja bażi li tiżdied fid-drabi ta' tibdil fl- EC50 (FC) ta' darunavir kienet assoċjata ma' tnaqqis firrispons viroloġiku.
English: Recommended dose for treatment-naïve paediatric patients (3 to 17 years) with darunavir tablets and ritonavir a
Maltese: Doża rrakkomandata għall-pazjenti pedjatriċi li diġà ħadu kura qabel (3 snin sa 17-il sena) bilpilloli darunavir u ritonavir a
English: The effects of other medicines might be influenced if you take darunavir.
Maltese: L-effetti ta' mediċini oħra jistgħu jiġu influwenzati jekk inti tieħu darunavir.
English: Darunavir Mylan 400 mg film-coated tablets EU/1/16/1140/022
Maltese: Darunavir Mylan 400 mg pilloli miksijin b'rita EU/1/16/1140/022
English: Each tablet contains 600 milligram of darunavir.
Maltese: Kull pillola fiha 600 milligramma ta' darunavir bħala ethanolate.
English: V32I, L33F, I47V, I50V, I54L or M, T74P, L76V, I84V or L89V) b fold change in EC50 c “Patients with no/non-naïve use of ENF” are patients who did not use ENF or who used ENF but not for the first time d “Patients with naïve use of ENF” are patients who used ENF for the first time
Maltese: (V11I, V32I, L33F, I47V, I50V, I54L jew M, T74P, L76V, I84V u L89V) ta' darunavir jew aktar kienu preżenti fil-linja bażi jew meta dawn il-mutazzjonijiet żviluppaw waqt il-kura.
English: Cold form PVC/Al/OPA-Al blister pack containing 30 tablets and 30x1 tablets.
Maltese: Pakkett bil-folji tal-PVC/Al/OPA-Al f'forma kiesħa li fih 30 pillola u 30x1 pillola.
English: White to off-white, oval shaped, biconvex film-coated tablets approximately 19.2 mm by 9.6 mm, debossed with ‘M' on one side and ‘DV4' on the other side.
Maltese: Pillola miksija b'rita bojod għal offwajt, b'forma ovali, imbuzzati fuq iż-żewġ naħat, ta' madwar 19.2 mm b'9.6 mm, imnaqqxa b' ‘M' fuq naħa waħda u ‘DV4' fuq in-naħa l-oħra.
English: Darunavir: comparison of darunavir/ritonavir 400/100 mg twice daily vs. darunavir/ritonavir 400/100 mg in combination with indinavir 800 mg twice daily.
Maltese: Darunavir: tqabbil ta' darunavir/ritonavir 400/100 mg darbtejn kuljum ma' darunavir/ritonavir 400/100 mg flimkien ma' indinavir 800 mg darbtejn kuljum
English: Not known rash (including macular, maculopapular, papular, erythematous and pruritic rash), pruritus angioedema, generalised rash, allergic dermatitis, urticaria, eczema, erythema, hyperhidrosis, night sweats, alopecia, acne, dry skin, nail pigmentation
Maltese: Mhux komuni anġjoedima, raxx mifrux, dermatite allerġika, urtikarja, ekżema, ħmura, iperidrosi, għaraq billejl, alopeċja, akne, ġilda xotta, pigmentazzjoni fid-difer
English: Boosted darunavir may increase antifungal plasma concentrations and posaconazole, isavuconazole, itraconazole or fluconazole may increase darunavir concentrations.
Maltese: Ma ġiex studjat. darunavir jista' jżid ilkonċentrazzjonijiet tal-mediċina antifungali fil-plażma u posaconazole, isavuconazole, itraconazole, jew fluconazole jistgħu jżidu lkonċentrazzjonijiet ta' darunavir.
English: White to off-white, oval shaped, biconvex film coated tablets approximately 16.5 mm by 8.2 mm, debossed with 'M' on one side of the tablet and 'DV3' on other side.
Maltese: Pilloli miksija b'rita bojod għal offwajt, b'forma ovali, imbuzzati fuq iż-żewġ naħat, ta' madwar 16.5 mm b'8.2 mm, imnaqqxa b'‘M' fuq naħa waħda u ‘DV3' fuq in-naħa l-oħra.
English: Treatment of overdose with darunavir consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Maltese: It-trattament ta' doża eċċessiva ta' darunavir jikkonsisti f'miżuri ġenerali ta' għajnuna inkluż monitoraġġ tas-sinjali vitali u osservazzjoni ta' l-istat kliniku tal-pazjent.
English: Concomitant use of darunavir with low dose ritonavir and elbasvir/grazoprevir is contraindicated (see section 4.3).
Maltese: L-użu ta' darunavir flimkien ma' doża ta' ritonavir u elbasvir/grazoprevir huwa kontraindikat (ara sezzjoni 4.3).
English: Darunavir Mylan 300 mg film-coated tablets EU/1/16/1140/012
Maltese: Darunavir Mylan 300 mg pilloli miksijin b'rita EU/1/16/1140/012
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 10
English: - Rifabutin (against bacterial infections) - Sildenafil, vardenafil, tadalafil (for erectile dysfunction or high blood pressure in the pulmonary circulation) - Amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone (to treat depression and anxiety) - Maraviroc (to treat HIV infection) - Methadone (to treat opiate dependance) - Carbamazepine, clonazepam (to prevent seizures or to treat certain types of nerve pain) - Colchicine (to treat gout or familial Mediterranean fever) - Bosentan (to treat high blood pressure in the pulmonary circulation)
Maltese: - Rifabutin (kontra infezzjonijiet batterjali) - Sildenafil, vardenafil, tadalafil (għal anormalità erettili jew pressjoni għolja fiċ-ċirkolazzjoni tal-pulmuni) - Amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone (biex tikkura depressjoni u ansjetà) - Maraviroc (għal kura ta' infezzjoni bl-HIV) - Methadone (biex tikkura dipendenza fuq l-opjati) - Carbamazepine, clonazepam (biex tilqa' kontra l-aċċessjonijiet jew biex tikkura ċerti tipi ta'
English: HDPE bottle pack with a PP screw cap containing 60 and 240 tablets.
Maltese: Flixkun tal-HDPE b'tapp bil-kamini tal-PP li jkun fih 60 u 240 pillola.
English: Darunavir Mylan 800 mg film-coated tablets EU/1/16/1140/039
Maltese: Darunavir Mylan 800 mg pilloli miksijin b'rita EU/1/16/1140/039
English: Administration of darunavir did not cause a statistically significant increase in the incidence of any other benign or malignant neoplasm in mice or rats.
Maltese: L-amministrazzjoni ta' darunavir ma kkawżatx żieda statistikament sinifikanti ta' kwalunkwe neoplażmu beninn jew malinn ieħor filġrieden u l-firien.
English: In women receiving darunavir/cobicistat during the second trimester of pregnancy, mean intra-individual values for total darunavir Cmax, AUC24h and Cmin were 49%, 56% and 92% lower, respectively, as compared with postpartum; during the third trimester of pregnancy, total darunavir Cmax, AUC24h and Cmin values were 37%, 50% and 89% lower, respectively, as compared with postpartum.
Maltese: F'nisa li kienu qed jirċievu darunavir/cobicistat matul it-tieni trimestru tat-tqala, valuri medji fl-istess individwu għas-Cmax, l- AUC24h u s-Cmin ta' darunavir totali kienu 49%, 56% u 92% aktar baxxi, rispettivament, meta mqabbla ma wara t-twelid; matul it-tielet trimestru tat-tqala, il valuri tas-Cmax, l-AUC24h u s- Cmin ta' darunavir totali kienu 37%, 50% u 89% aktar baxxi rispettivament, meta mqabbla ma' wara t-twelid.
English: OR - 800 milligram darunavir (2 tablets containing 400 milligram of darunavir or 1 tablet containing 800 milligram of darunavir) together with 100 milligram ritonavir once daily.
Maltese: JEW - 800 milligramma darunavir (2 pilloli li fihom 400 milligramma ta' darunavir jew pillola waħda li fiha 800 milligramma ta' darunavir) flimkien ma' 100 milligramma ritonavir darba kuljum.
English: - In the evening, take 600 milligram darunavir together with 100 milligram ritonavir.
Maltese: - Filgħodu, ħu 600 milligramma darunavir flimkien ma' 100 milligramma ritonavir.
English: Darunavir Mylan 600 mg film-coated tablets EU/1/16/1140/030
Maltese: Darunavir Mylan 600 mg pilloli miksijin b'rita EU/1/16/1140/030
English: Clinical monitoring is recommended when co administering darunavir with low dose ritonavir and clonazepam.
Maltese: Huwa rrakkomandat monitoraġġ kliniku meta darunavir intensifikat jingħata flimkien ma' clonazepam.
English: Darunavir/ ritonavir 600/100 mg twice daily N=296
Maltese: Darunavir/ ritonavir 600/100 mg darbtejn kuljum N=296
English: CD4+ percent change from baselineb CD4+ cell count mean change from baseline b a
Maltese: CD4+ bidla medja fl-għadd ta' ċelluli mil-linja bażi b
English: Carvedilol Metoprolol Timolol
Maltese: TAR-RIĊETTURI β Carvedilol
English: Therapy with Darunavir/cobicistat should not be initiated during pregnancy, and women who become pregnant during therapy with Darunavir/cobicistat should be switched to an alternative regimen (see sections 4.2 and 4.4).
Maltese: Terapija b'Darunavir/cobicistat m'għandhiex tinbeda waqt it-tqala, u nisa li joħorġu tqal waqt it-terapija b'Darunavir/cobicistat għandhom jinqalbu għal skeda alternattiva (ara sezzjonjiet 4.2 u 4.4).
English: 10 kg to < 15 kg N=5
Maltese: Darunavir/ritonavir 10 kg sa < 15 kg N=5
English: With baseline CD4+ cell count < 200
Maltese: B'għadd taċċelluli CD4+ < 200 fil-linja ba¿i
English: Tell your doctor if you take: - Alfentanil (injectable strong and short-acting painkiller that is used for surgical procedures) - Digoxin (to treat certain heart disorders) - Clarithromycin (antibiotic) - Itraconazole, isavuconazole, fluconazole, posaconazole, clotrimazole (to treat fungal infections).
Maltese: Għid lit-tabib tiegħek jekk tieħu: - Alfentanil (mediċina qawwija u taħdem għal żmien qasir li tingħata minn ġol-vini u tintuża għal proċeduri kirurġiċibiex ittaffi l-uġigħ ) - Digoxin (biex tikkura ċertu mard tal-qalb) - Clarithromycin (antibijotiku) - Itraconazole, isavuconazole, fluconazole, posaconazole, clotrimazole (biex tikkura infezzjonijiet fungali).
English: Pregnant or breast-feeding mothers should not take darunavir with cobicistat.
Maltese: Interazzjonijiet ma' prodotti mediċinali u forom oħra ta' interazzjoni Studji ta' interazzjoni twettqu biss f'adulti.
English: Darunavir Mylan 150 mg film-coated tablets are white to off-white, capsule shaped, with two curved sides, marked with M on one side and DV2 on the other side.
Maltese: Darunavir Mylan 150 mg pilloli miksija b'rita huma bojod għal offwajt, b'forma ovali, imbuzzati fuq iż-żewġ naħat, imnaqqxa b'M fuq naħa waħda u DV2 fuq in-naħa l-oħra.
English: Postpartum (6-12 weeks) (n=16)
Maltese: Wara t-twelid (6 ġimgħat-12-il ġimgħ a) (n=16)
English: Co-administration with the combination product lopinavir/ritonavir (see section 4.5).
Maltese: Il-frekwenza m'hijiex magħrufa (ara sezzjoni 4.4).
English: Not known rash (including macular, maculopapular, papular, erythematous, pruritic rash, generalised rash, and allergic dermatitis)
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda Komuni ħafna raxx (inkluż makulari, makulopapulari, papulari, raxx bil-ħmura, raxx bil-ħakk, raxx mifrux u dermatite allerġika
English: Cold form PVC/Al/OPA-Al blister pack containing 30 and 60 tablets and 60x1 tablets.
Maltese: Folja tal-PVC/PE/PVDC-Al f'forma kiesħa li fiha 30 u 60 pillola u 60 x1 pillola.
English: Other severe side effects were diabetes (common), and inflammation of the pancreas (uncommon).
Maltese: Effetti sekondarji severi oħra kienu dijabete (komuni), u infjammazzjoni tal-frixa (mhux komuni).
English: Darunavir Mylan 400 mg and 800 mg film-coated tablets contain less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Maltese: Darunavir Mylan 400 mg, u 800 mg pilloli miksijin b'rita fihom inqas minn 1 mmol sodium (23 mg) f'kull doża, u għalhekk huma prattikament ħielsa mis-sodium.
English: White to off-white, oval shaped, biconvex film-coated tablets approximately 21.2 mm by 10.6 mm, debossed with ‘M' on one side and ‘DV5' on the other side.
Maltese: Pilloli miksija b'rita bojod għal offwajt, b'forma ovali, imbuzzati fuq iż-żewġ naħat, ta' madwar 21.2 mm b'10.6 mm, imnaqqxa b'‘M' fuq naħa waħda u ‘DV5' fuq in-naħa l-oħra.
English: EU/1/16/1140/012 EU/1/16/1140/013 EU/1/16/1140/014 EU/1/16/1140/015 EU/1/16/1140/016 EU/1/16/1140/017 EU/1/16/1140/018 EU/1/16/1140/019 EU/1/16/1140/020 EU/1/16/1140/021
Maltese: EU/1/16/1140/016 EU/1/16/1140/017 EU/1/16/1140/018 EU/1/16/1140/019 EU/1/16/1140/020
English: Darunavir/ ritonavir 600/100 mg twice daily N=298
Maltese: Darunavir/ ritonavir 600/100 mg darbtejn kuljum N=298
English: Immune reconstitution inflammatory syndrome
Maltese: Sindrome infjammatorju ta' rikostituzzjoni immuni
English: POWER 1 and POWER 2 are randomised, controlled trials comparing darunavir co-administered with ritonavir (600/100 mg twice daily) with a control group receiving an investigator-selected PI(s) regimen in HIV-1 infected patients who had previously failed more than 1 PI containing regimen.
Maltese: POWER 1 u POWER 2 huma provi kkontrollati randomised li jqabblu darunavir mogħti flimkien ma' ritonavir (600/100 mg darbtejn kuljum) ma' grupp ta' kontroll li qed jirċievu skeda ta' għoti ta' dożi ta' PIs magħzula mill-investigatur f'pazjenti infettati bl-HIV-1 li qabel kienu fallew aktar minn skeda waħda ta' għoti ta' dożi li kien fih PI. OBR li kien jikkonsisti f'min ta' lanqas 2 NRTIs b'enfuvirtide (ENF) jew mingħajru intuża fiż-żewġ provi.
English: For information on cobicistat pharmacokinetic properties, consult the cobicistat Summary of Product Characteristics.
Maltese: Għal aktar informazzjoni dwar cobicistat, fittex fis-Sommarju tal-Karattersitiċi talProdott ta' cobicistat.
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 4.2).
English: Concomitant use of boosted darunavir and corticosteroids that are metabolised by CYP3A (e.g. fluticasone propionate or other inhaled or nasal corticosteroids) may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Maltese: L-użu flimkien ta' darunavir intensifikat u kortikosterojdi li jiġu metabolizzati permezz ta' CYP3A (eż. fluticasone propionate jew kortikosterojdi oħra li jinġibdu man-nifs jew li jingħataw minn ġol-imnieħer) jista' jżid ir-riskju li jiżviluppaw effetti sistemiċi talkoritkosterojdi, inkluż is-sindrome ta' Cushing u soppressjoni talglandoli adrenali.
English: Boosted darunavir can be expected to increase the plasma concentrations of calcium channel blockers.
Maltese: Darunavir intensifikat jista' jkun mistenni li jżid ilkonċentrazzjonijiet ta' imblokkaturi talkanali tal-kalċju fil-plażma.
English: Virologic response was defined as a decrease in plasma HIV-1 RNA viral load of at least 1.0 log10 versus baseline.
Maltese: Rispons viroloġiku kien iddefinit bħala tnaqqis ta' mill-anqas 1.0 log10 versus il-linja bażi fit-tagħbija virali ta' RNA ta' HIV-1 fil-plażma.
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: Darunavir Mylan 75 mg, 150 mg, 300 mg and 600 mg tablets can be used to construct the twice daily 600 mg regimen.
Maltese: Il-pilloli Darunavir Mylan 75 mg, 150 mg, 300 mg, u 600 mg jistgħu jintużaw biex tgħaqqad l-iskeda ta' għoti ta' doża ta' 600 mg darbtejn kuljum.
English: Rare headache, peripheral neuropathy, dizziness lethargy, paraesthesia, hypoaesthesia, dysgeusia, disturbance in attention, memory impairment, somnolence syncope, convulsion, ageusia, sleep phase rhythm disturbance
Maltese: Rari letarġija, paraestesija, ipoestesija, disgewżja, disturb fl-attenzjoni, indeboliment tal-memorja, ħeddla ta' rqad,
English: Darunavir Mylan 600 mg film-coated tablets are available in blister packs containing 30 and 60 tablets and in plastic bottles containing 30, 60 and 90 tablets.
Maltese: Darunavir Mylan 600 mg pilloli miksija b'rita huma disponibbli f'pakketti b'folji li fihom 30 u 60 pillola u fi fliexken tal-plastik li fihom 30, 60 u 90 pillola..