FrancophonIA/ELRC3.0 huggingface dataset:
English: PREZISTA 800 mg film-coated tablets EU/1/06/380/007 - 30 film-coated tablets EU/1/06/380/008 - 90 film-coated tablets (3 x 30)
Maltese: PREZISTA 800 mg pilloli miksijin b'rita EU/1/06/380/007 - 30 pillola miksijin b'rita EU/1/06/380/008 - 90 pillola miksijin b'rita (3 x 30)
English: PREZISTA 75 mg film-coated tablets PREZISTA 150 mg film-coated tablets PREZISTA 300 mg film-coated tablets PREZISTA 600 mg film-coated tablets
Maltese: PREZISTA 75 mg pilloli miksijin b'rita PREZISTA 150 mg pilloli miksijin b'rita PREZISTA 300 mg pilloli miksijin b'rita PREZISTA 600 mg pilloli miksijin b'rita
English: ethinylestradiol AUC ↓ 44% ethinylestradiol Cmin ↓ 62% ethinylestradiol Cmax ↓ 32% norethindrone AUC ↓ 14% norethindrone Cmin ↓ 30% norethindrone Cmax ↔ with darunavir/ritonavir
Maltese: AUC ta' ethinylestradiol ↓ 44% Cmin ta' ethinylestradiol ↓ 62% Cmax ta' ethinylestradiol ↓ 32% AUC ta' norethindrone ↓ 14% Cmin ta' norethindrone ↓ 30% Cmax ta' norethindrone ↔ b'darunavir/ritonavir
English: (not applicable for PREZISTA co-administered with ritonavir)
Maltese: (ma japplikax għal PREZISTA mogħti flimkien ma' ritonavir)
English: PREZISTA contains the active substance darunavir.
Maltese: X'fih PREZISTA - Is-sustanza attiva hija darunavir.
English: In most cases, PREZISTA can be combined with anti-HIV medicines belonging to another class [e.g. NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists and FIs (fusion inhibitors)].
Maltese: F'ħafna mill-każi PREZISTA jista' jittieħed flimkien ma' mediċini li jagħmlu parti minn klassi oħra [eż. NRTI's (impedituri tan-nucleoside reverse transcriptase), NNRTI's (impedituri tan-non nucleoside reverse transcriptase), antagonisti ta' CCR5 u FIs (impedituri ta' fużjoni)].
English: HERBAL PRODUCTS St John's wort
Maltese: John's wort.
English: ≥ 15 kg to < 30 kg 600 mg (6 ml) PREZISTA/100 mg (1.2 ml) ritonavir once daily
Maltese: ≥ 15 kg sa < 30 kg 600 mg (6 ml) PREZISTA/100 mg (1.2 ml) ritonavir darba kuljum
English: HIV-1 RNA < 50 copies/ml With Baseline HIV-1 RNA (copies/ml)
Maltese: HIV-1 RNA < 50 kopja/ml B'HIV-1 RNA (kopja/ml)
English: Marketing Authorisation Holder Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, il-Belġju
English: The film-coating contains poly(vinyl alcohol) - partially hydrolysed, macrogol 3350, titanium dioxide (E171), talc, sunset yellow FCF (E110).
Maltese: Il-kisja tar-rita fiha poly(vinyl alkoħol) - parzjalment idrolizzat, macrogol 3350, titanium dioxide (E171), terra, sunset yellow FCF (E110).
English: Tel: +370 5 278 68 88 lt@its.jnj.com
Maltese: JOHNSON" Tel: +370 5 278 68 88 lt@its.jnj.com
English: During the darunavir/ritonavir clinical development program (N=3,063), hepatitis was reported in 0.5% of patients receiving combination antiretroviral therapy with PREZISTA/ritonavir.
Maltese: Waqt il-programm ta' żvilupp kliniku (N=3,063) ta' darunavir/ritonavir, l-epatite kienet irrappurtata f'0.5% tal-pazjenti li kienu qed jirċievu terapija antiretrovirali mħallta bi PREZISTA/ritonavir.
English: The film-coating contains poly(vinyl alcohol) - partially hydrolysed, macrogol 3350, titanium dioxide (E171), talc, iron oxide red (E172).
Maltese: Il-kisja tar-rita fiha poly(vinyl alkoħol)parzjalment idrolizzat, macrogol 3350, titanium dioxide (E171), terra, iron oxide red (E172).
English: HIV ANTIRETROVIRALS Integrase strand transfer inhibitors Dolutegravir dolutegravir AUC ↓ 22% dolutegravir C24h ↓ 38% dolutegravir Cmax ↓ 11% darunavir ↔*
Maltese: Dolutegravir dolutegravir AUC ↓ 22% dolutegravir C24h ↓ 38% dolutegravir Cmax ↓ 11% darunavir ↔*
English: Tel/Tél: +32 14 64 94 11 janssen@jacbe.jnj.com
Maltese: +32 14 64 94 11 janssen@jacbe.jnj.com
English: Glecaprevir/pibrentasvir Based on theoretical considerations boosted PREZISTA may increase the exposure to glecaprevir and pibrentasvir.
Maltese: Glecaprevir/pibrentasvir Abbażi ta' konsiderazzjonijiet teoretiċi PREZISTA intensifikat jista' jżid lesponiment għal glecaprevir u pibrentasvir.
English: Saquinavir: comparison of saquinavir/ritonavir 1,000/100 mg twice daily vs. saquinavir/darunavir/ritonavir 1,000/400/100 mg twice daily Darunavir: comparison of darunavir/ritonavir 400/100 mg twice daily vs. darunavir/ritonavir 400/100 mg in combination with saquinavir 1,000 mg twice daily.
Maltese: Saquinavir: tqabbil ta' saquinavir/ritonavir 1,000/100 mg darbtejn kuljum ma' saquinavir/darunavir/ritonavir 1,000/400/100 mg darbtejn kuljum Darunavir: tqabbil ta' darunavir/ritonavir 400/100 mg darbtejn kuljum ma' darunavir/ritonavir 400/100 mg flimkien ma' saquinavir 1,000 mg darbtejn kuljum
English: In GS-US216-130 baseline phenotype was not available
Maltese: Fil-linja bażi ta' GS-US216-130 il-fenotip ma kienx disponibbli.
English: d.o.o.
Maltese: IAS-USA
English: Other special populations Patients co-infected with hepatitis B and/or hepatitis C virus
Maltese: Pazjenti ko-infettati bil-virus tal-epatite B u/jew Ċ
English: Lurasidone, pimozide, quetiapine or sertindole to treat psychiatric conditions Ergot alkaloids like ergotamine, dihydroergotamine, ergometrine and methylergonovine to treat migraine headaches
Maltese: Lurasidone, pimozide, quetiapine jew sertindole biex tikkura kundizzjonijiet psikjatriċi Alkalojdi tal-ergot bħal ergotamine, dihydroergotamine, ergometrine u methylergonovine biex tikkura l-emigranja
English: These results were sustained up to 192 weeks of treatment in the ARTEMIS trial.
Maltese: Dawn ir-riżultati kienu sostnuti sa 192 ġimgħa ta' kura fil-prova ARTEMIS.
English: PREZISTA 300 mg tablets and 600 mg tablets contain sunset yellow FCF (E110) which may cause an allergic reaction.
Maltese: Pilloli PREZISTA ta' 300 mg u 600 mg fihom sunset yellow FCF (E110) li jista' jikkawża reazzjoni allerġika.
English: PREZISTA has only been used in limited numbers of patients 65 years or older.
Maltese: PREZISTA kien użat biss f'numru limitat ta' pazjenti ta' 65 sena jew aktar.
English: Proportion (%) of patients with response (HIV-1 RNA < 50 copies/ml at week 24) to PREZISTA co-administered with ritonavir (600/100 mg twice daily) by baseline genotype a, and baseline darunavir FC and by use of enfuvirtide (ENF): As treated analysis of the POWER and DUET trials.
Maltese: Proporzjon (%) ta' pazjenti b'rispons (HIV-1 RNA < 50 kopja/ml fl-24 ġimgħa) għal PREZISTA amministrat flimkien ma' ritonavir (600 mg/100 mg darbtejn kuljum) skond il-ġenotip fil-linja bażi a, u l-FC ta' darunavir fil-linja bażi u permezz ta' l-użu ta' enfuvirtide (ENF):
English: ≥ 30 kg-< 40 kg 675 mg PREZISTA/100 mg ritonavir once daily
Maltese: ≥ 30 kg-< 40 kg 675 mg PREZISTA/100 mg ritonavir darba kuljum
English: White caplet shaped tablet of 9.2 mm, debossed with “75” on one side and “TMC” on the other side.
Maltese: Pillola bajda b'forma ta' kapsula ta' 9.2 mm, imnaqqxa b'“75” fuq naħa waħda u “TMC” fuq in-naħa l-oħra.
English: Take the dose of PREZISTA.
Maltese: Ħu d-doża ta' PREZISTA.
English: Ethinylestradiol (3 mg/0.02 mg once daily)
Maltese: Drospirenone Ethinylestradiol (3 mg/0.
English: - The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, crospovidone, magnesium stearate, hypromellose.
Maltese: - Is-sustanzi mhux attivi l-oħra huma microcrystalline cellulose, colloidal anhydrous silica, crospovidone, magnesium stearate, hypromellose.
English: According to the TLOVR non-virologic failure censored algorithm 24 (30.0%) patients experienced virological failure, of which 17 (21.3%) patients were rebounders and 7 (8.8%) patients were non-responders.
Maltese: Skont l-algoriżmu ċċensurat ta' falliment mhux viroloġiku ta' TLOVR 24 (30.0%) pazjent esperjenzaw falliment viroloġiku, li minnhom 17 -il pazjent (21.3%) reġgħu lura għal li kienu u 7 (8.8%) pazjenti ma rrispondewx għall-kura.
English: PREZISTA 400 mg film-coated tablets PREZISTA 800 mg film-coated tablets
Maltese: PREZISTA 400 mg pilloli miksijin b'rita PREZISTA 800 mg pilloli miksijin b'rita
English: Metabolism and nutrition disorders common anorexia, diabetes mellitus, hypercholesterolaemia, hypertriglyceridaemia, hyperlipidaemia
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni komuni anoressija, dijabete mellitus, iperkolesterolemija, ipertrigliċeridemija, iperlipidemija
English: Orange oval shaped tablet of 17.3 mm, debossed with “300MG” on one side and “TMC114” on the other side.
Maltese: Pillola oranġjo b'forma ovali ta' 17.3 mm, imnaqqxa b'“300MG” fuq naħa waħda u “TMC114” fuq in-naħa l-oħra.
English: 380 mg (3.8 ml) PREZISTA/50 mg (0.6 ml) ritonavir twice daily
Maltese: 380 mg (3.8 ml) PREZISTA/50 mg (0.6 ml) ritonavir darbtejn kuljum
English: White oval shaped tablet of 13.7 mm, debossed with “150” on one side and “TMC” on the other side.
Maltese: Pillola bajda b'forma ovali ta' 13.7 mm, imnaqqxa b'“150” fuq naħa waħda u “TMC” fuq in-naħa loħra.
English: How to store PREZISTA
Maltese: Mediċini oħra u PREZISTA
English: ≥ 15 kg-< 30 kg 600 mg PREZISTA/100 mg ritonavir once daily
Maltese: ≥ 15 kg-< 30 kg 600 mg PREZISTA/100 mg ritonavir darba kuljum
English: 460 mg (4.6 ml) PREZISTA/60 mg (0.8 ml) ritonavir twice daily
Maltese: 460 mg (4.6 ml) PREZISTA/60 mg (0.8 ml) ritonavir darbtejn kuljum
English: more than 40 kilograms
Maltese:  40 kg
English: b PREZISTA/100 mg (1.2 ml) ritonavir once daily
Maltese: b PREZISTA/100 mg (1.2 ml) ritonavir darba kuljum
English: TITAN is a randomised, controlled, open-label Phase III trial comparing PREZISTA co-administered with ritonavir (600/100 mg twice daily) versus lopinavir/ritonavir (400/100 mg twice daily) in ART-experienced, lopinavir naïve HIV-1 infected adult patients.
Maltese: TITAN hija prova tal-Fażi III randomised, ikkontrollata, open-label, li tqabbel PREZISTA mogħti flimkien ma' ritonavir (600/100 mg darbtejn kuljum) versus lopinavir/ritonavir (400/100 mg darbtejn kuljum) f'pazjenti adulti infettati bl-HIV-1 li ġieli ħadu ART qabel iżda qatt ma ħadu lopinavir.
English: PREZISTA 75 mg, 150 mg and 600 mg film-coated tablets 3 years
Maltese: PREZISTA 75 mg, 150 mg u 600 mg pilloli miksijin b'rita 3 snin
English: PREZISTA oral suspension contains sodium methyl parahydroxybenzoate (E219) which may cause allergic reactions (possibly delayed).
Maltese: PREZISTA suspensjoni orali fih sodium methyl parahydroxybenzoate (E219) li jista' jikkawża reazzjonijiet allerġiċi (possibbilment li joħorġu wara ż-żmien).
English: ritonavir oral solution: 80 milligram per milliliter
Maltese: soluzzjoni orali ta' ritonavir: 80 milligramma f'kull millilitru
English: ANTINEOPLASTICS Dasatinib
Maltese: ANTINEOPLASTIĊI
English: Amber-coloured multiple-dose glass bottle for 200 ml suspension with a polypropylene closure with LDPE liner packaged with a 6 ml oral dosing pipette with 0.2 ml gradations.
Maltese: Flixkun tal-ħġieġ ta' lewn safrani li fih dożi multipli għal suspensjoni ta' 200 ml b'tapp tal-polypropylene b'inforra ta' LDPE ippakkjat b'pipetta tad-dożaġġ orali ta' 6 ml bi gradazzjonijiet ta' 0.2 ml.
English: ANTIBIOTIC Clarithromycin 500 mg twice daily clarithromycin AUC ↑ 57% clarithromycin Cmin ↑ 174% clarithromycin Cmax ↑ 26% darunavir AUC ↓ 13% darunavir Cmin ↑ 1% darunavir Cmax ↓ 17% 14-OH-clarithromycin concentrations were not detectable when combined with PREZISTA/ritonavir.
Maltese: ANTIBIJOTIKU Clarithromycin 500 mg darbtejn kuljum clarithromycin AUC ↑ 57% clarithromycin Cmin ↑ 174% clarithromycin Cmax ↑ 26% darunavir AUC ↓ 13% darunavir Cmin ↑ 1% darunavir Cmax ↓ 17% Konċentrazzjonijiet ta' 14-OH-clarithromycin ma kinux b'tali mod li setgħu jiġu identifikati meta ngħata flimkien ma' PREZISTA/ritonavir. (↑ clarithromycin minn impediment ta' CYP3A u x'aktarx minn impediment ta' P-gp)
English: PREZISTA co-administered with low dose ritonavir and amiodarone, bepridil, dronedarone, ivabradine, quinidine, or ranolazine is contraindicated (see section 4.3).
Maltese: PREZISTA mogħti flimkien ma' doża baxxa ta' ritonavir u amiodarone, bepridil, dronedarone, ivabradine, quinidine, jew ranolazine huwa kontraindikat (ara sezzjoni 4.3).
English: Ethinylestradiol Norethindrone 35 g/1 mg once daily drospirenone AUC ↑ 58% drospirenone Cmin ND drospirenone Cmax ↑ 15% ethinylestradiol AUC  30% ethinylestradiol Cmin ND ethinylestradiol Cmax  14% with darunavir/cobicistat ethinylestradiol AUC ↓ 44% ethinylestradiol Cmin ↓ 62% ethinylestradiol Cmax ↓ 32% norethindrone AUC ↓ 14% norethindrone Cmin ↓ 30% norethindrone Cmax ↔ with darunavir/ritonavir
Maltese: Ethinylestradiol Norethindrone 35 g/1 darba kuljum drospirenone AUC ↑ 58% drospirenone Cmin ND drospirenone Cmax ↑ 15% ethinylestradiol AUC  30% ethinylestradiol Cmin ND ethinylestradiol Cmax  14% b'darunavir/cobicistat
English: Treatment of overdose with PREZISTA 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' PREZISTA jikkonsisti f'miżuri ġenerali ta' għajnuna inkluż monitoraġġ tas-sinjali vitali u osservazzjoni ta' l-istat kliniku tal-pazjent.
English: Each milliliter contains 100 milligram of darunavir (as ethanolate).
Maltese: Kull millitru fih 100 milligramma ta' darunavir (bħala ethanolate).
English: Darunavir binds predominantly to 1-acid glycoprotein.
Maltese: Darunavir jintrabat b'mod predominanti mal-1-glikoproteina aċida.
English: See the Summary of Product Characteristics for PREZISTA 75 mg, 150 mg, 300 mg and 600 mg tablets (see section 4.5).
Maltese: Ara s-Sommarju tal-Karattersitiċi talProdott għall-pilloli PREZISTA 75 mg, 150 mg, 300 mg u 600 mg (ara sezzjoni 4.5).
English: Ritonavir inhibits the transporters P-glycoprotein, OATP1B1 and OATP1B3, and co-administration with substrates of these transporters can result in increased plasma concentrations of these compounds (e.g. dabigatran etexilate, digoxin, statins and bosentan; see the Interaction table below).
Maltese: Ritonavir jinibixxi t-trasportaturi glikoproteina P, OATP1B1 u OATP1B3, u l-għoti flimkien ma' sustrati ta' dawn it-trasportaturi jista' jwassal għal żieda fil-konċentrazzjonijiet ta'dawn is-sustanzi filplażma (eż. dabigatran etexilate, digoxin, statins u bosentan; ara t-Tabella ta' interazzjoni taħt).
English: 100 milligram ritonavir oral solution: 80 milligram per milliliter
Maltese: 100 milligramma soluzzjoni orali ta' ritonavir: 80 milligramma f'kull millilitru
English: The film-coating contains poly(vinyl alcohol) - partially hydrolysed, macrogol 3350, titanium dioxide (E171), talc.
Maltese: Il-kisja tar-rita fiha poly(vinyl alkoħol) - parzjalment idrolizzat, macrogol 3350, titanium dioxide (E171), terra.
English: see section 4.5) - sildenafil - when used for the treatment of pulmonary arterial hypertension, avanafil - simvastatin, lovastatin, lomitapide (see section 4.5) - dabigatran, ticagrelor (see section 4.5).
Maltese: - simvastatin, lovastatin u lomitapide (ara sezzjoni 4.5) - dabigatran, ticagrelor (ara sezzjoni 4.5).
English: PREZISTA suspension is administered orally.
Maltese: PREZISTA suspensjoni orali hi disponibbli wkoll.
English: - The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, crospovidone, magnesium stearate.
Maltese: - Is-sustanzi mhux attivi l-oħra huma microcrystalline cellulose, colloidal anhydrous silica, crospovidone, magnesium stearate.
English: - Buprenorphine/naloxone (medicines to treat opioid dependence) - Salmeterol (medicine to treat asthma) - Artemether/lumefantrine (a combination medicine to treat malaria) - Dasatinib, everolimus, irinotecan, nilotinib, vinblastine, vincristine (to treat cancer) - Sildenafil, tadalafil, vardenafil (for erectile dysfunction or to treat a heart and lung disorder called pulmonary arterial hypertension) - Glecaprevir/pibrentasvir, simeprevir (to treat hepatitis C infection) - Fentanyl, oxycodone, tramadol (to treat pain) - Fesoterodine, solifenacin (to treat urologic disorders).
Maltese: - Buprenorphine/naloxone (mediċini biex tikkura d-dipendenza fuq l-opjojdi) - Salmeterol (mediċina biex tikkura l-ażma) - Artemether/lumefantrine (mediċina kombinata għal kura tal-malarja) - Dasatinib, everolimus, irinotecan, nilotinib, vinblastine, vincristine (biex tikkura l-kanċer) - Sildenafil, tadalafil, vardenafil (għall-impotenza jew biex tikkura disturb tal-qalb u tal-pulmun imsejjaħ pressjoni għolja fil-pulmuni tal-arterji) - Glecaprevir/pibrentasvir, simeprevir (biex titratta infezzjoni tal-epatite C) - Fentanyl, oxycodone, tramadol (biex jittrattaw l-uġigħ)
English: PREZISTA might increase the risk for elevated potassium levels by drospirenone.
Maltese: PREZISTA jista' jżid ir-riskju ta' żieda fil-livelli tal-potassium minn drospirenone.
English: Number of mutations from the list of mutations associated with a diminished response to PREZISTA/ritonavir (V11I, V32I, L33F, I47V, I50V, I54L or M, T74P, L76V, I84V or L89V) fold change in EC50 “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 “Patients with naïve use of ENF” are patients who used ENF for the first time
Maltese: Numru ta' tibdiliet ġenetiċi mill-lista ta' tibdiliet ġenetiċi assoċjati ma' nuqqas ta' rispons għall-PREZISTA/ritonavir (V11I, V32I, L33F, I47V, I50V, I54L jew M, T74P, L76V, I84V jew L89V) drabi ta' bidla fl-EC50 “Pazjenti li ma użawx ENF jew li użaw ENF qabel” huma pazjenti li ma użawx ENF jew li wżaw ENF iżda mhux għallewwel darba “Pazjenti li qatt ma użaw ENF” huma pazjenti li wżaw ENF għall-ewwel darba
English: 100 milligram (1.2 milliliter)
Maltese: 600 milligramma (6 millilitri) 100 milligramma (1.2 millilitri)
English: An increase of systemic exposure to darunavir was observed when PREZISTA co-administered with 100 mg ritonavir was co-administered with rifabutin (150 mg once every other day).
Maltese: Żieda fl-esponiment sistemiku għal darunavir kienet osservata meta PREZISTA mogħti flimkien ma' 100 mg ritonavir ingħata flimkien ma' rifabutin (150 mg ġurnata iva u oħra le).
English: TLOVR non-VF censored algorithm based on HIV-1 RNA < 50 copies/ml, except for TITAN (HIV-1 RNA < 400 copies/ml) IAS-USA lists
Maltese: Algoritmu ċċensurat TLOVR mhux-VF ibbażat fuq HIV-1 RNA < 50 kopja/ml, minbarra għal TITAN (HIV-1 RNA < 400 kopja/ml)
English: One dose is between 15 and 30 kilograms 375 milligram PREZISTA + 50 milligram ritonavir twice a day between 30 and 40 kilograms 450 milligram PREZISTA + 60 milligram ritonavir twice a day more than 40 kilograms*
Maltese: 375 milligramma PREZISTA + 50 milligramma ritonavir darbtejn kuljum bejn 30 u 40 kilogramma
English: Excipient with known effect: Each tablet contains a maximum of 2.750 mg sunset yellow FCF (E110).
Maltese: Kull pillola fiha massimu ta' 2.750 mg sunset yellow FCF (E110).
English: PREZISTA tablets contain sunset yellow FCF (E110) which may cause allergic reactions.
Maltese: Il-pilloli PREZISTA fihom sunset yellow FCF (E110) li jista' jikkawża reazzjoni allerġika.
English: 800 mg (8 ml) PREZISTA/100 mg (1.2 ml) ritonavir once daily
Maltese: 800 mg (8 ml) PREZISTA/100 mg (1.2 ml) ritonavir darba kuljum
English: Interactions between PREZISTA/ritonavir and antiretroviral and non-antiretroviral medicinal products are listed in the table below.
Maltese: Interazzjonijiet bejn PREZISTA/ritonavir u prodotti mediċinali antiretrovirali u li ma humiex antiretrovirali huma elenkati fit-tabella t'hawn taħt.
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) - Buspirone, clorazepate, diazepam, estazolam, flurazepam, midazolam when used as injection,
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: PREZISTA/ ritonavir 600/100 mg twice daily n=131
Maltese: PREZISTA/ ritonavir 600/100 mg darbtejn kuljum n=131
English: The combination of avanafil and boosted PREZISTA is contraindicated (see section 4.3).
Maltese: Il-kombinazzjoni ta' avanafil u PREZISTA intensifikat hija kontraindikata (ara sezzjoni 4.3).
English: PREZISTA with low dose ritonavir with triazolam or oral midazolam is contraindicated (see section 4.3)
Maltese: PREZISTA ma' doża baxxa ta' ritonavir ma' triazolam jew midazolam orali huwa kontraindikat (ara sezzjoni 4.3)
English: Orange oval shaped tablet of 21.1 mm, debossed with “600MG” on one side and “TMC” on the other side.
Maltese: Pillola oranġjo b'forma ovali ta' 21.1 mm, imnaqqxa b'“600MG” fuq naħa waħda u “TMC” fuq innaħa l-oħra.
English: PREZISTA 75 mg film-coated tablets darunavir
Maltese: PREZISTA 75 mg pilloli miksijin b'rita darunavir
English: 800 mg PREZISTA/100 mg ritonavir once daily ritonavir oral solution: 80 mg/ml
Maltese: 800 mg PREZISTA/100 mg ritonavir darba kuljum soluzzjoni orali ta' ritonavir: 80 mg/ml
English: 450 mg PREZISTA/60 mg ritonavir twice daily
Maltese: 450 mg PREZISTA/60 mg ritonavir darbtejn kuljum
English: Avoid exposure to excessive heat.
Maltese: Evita l-espożizzjoni għal sħana eċċessiva.
English: Contains sunset yellow FCF (E110).
Maltese: Fih sunset yellow FCF (E110).
English: Co-administration of boosted PREZISTA and amiodarone, bepridil, dronedarone, ivabradine, quinidine, or ranolazine is contraindicated (see section 4.3).
Maltese: L-għoti ta' PREZISTA intensifikat flimkien ma' amiodarone, bepridil, dronedarone, ivabradine, quinidine, jew ranolazine huwa kontraindikat (ara sezzjoni 4.3).
English: PREZISTA oral suspension is available in packs of one bottle.
Maltese: PREZISTA suspensjoni orali huwa disponibbli f'pakketti ta' flixkun wieħed.
English: Concomitant use of PREZISTA with low dose ritonavir and elbasvir/grazoprevir is contraindicated (see section 4.3).
Maltese: L-użu ta' PREZISTA flimkien ma' doża baxxa ta' ritonavir u elbasvir/grazoprevir huwa kontraindikat (ara sezzjoni 4.3).
English: 600 mg PREZISTA/100 mg ritonavir twice daily ritonavir oral solution: 80 mg/ml
Maltese: 600 mg PREZISTA/100 mg ritonavir darbtejn kuljum b'soluzzjoni orali ta' ritonavir: 80 mg/ml
English: During the clinical development program (N=2,613 treatment-experienced subjects who initiated therapy with PREZISTA/ritonavir 600/100 mg twice daily), 51.3% of subjects experienced at least one adverse reaction.
Maltese: Waqt il-programm ta' żvilupp kliniku (N=2,613 individwu li kienu diġà ħadu kura qabel u li bdew terapija bi PREZISTA/ritonavir 600/100 mg darbtejn kuljum), 51.3% tal-individwi ħassew mill-anqas reazzjoni avversa waħda.
English: < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 10
Maltese: CD4+ ≥ 100 ċelluli x 10
English: Virologic failures were defined as: never suppressed: confirmed HIV-1 RNA < 1 log10 reduction from baseline and ≥ 50 copies/ml at the week-8; rebound: HIV-1 RNA < 50 copies/ml followed by confirmed HIV-1 RNA to ≥ 400 copies/ml or confirmed > 1 log10 HIV-1 RNA increase from the nadir; discontinuations with HIV-1 RNA ≥ 400 copies/ml at last visit IAS-USA lists
Maltese: Fallimenti viroloġiċi kienu ddefiniti bħala: qatt ma kienu soppressi: tnaqqis ikkonfermat ta'< 1 log10 ta' RNA ta' HIV-1 mill-linja bażi u ≥ 50 kopja/ml fil-ġimgħa 8; reġgħu ġew lura: < 50 kopja/ml ta' RNA ta' HIV-1 segwiti minn RNA ta' HIV-1 ikkonfermat sa ≥ 400 kopja/ml jew żieda kkonfermata ta' > 1 log10 ta' RNA ta' HIV-1 mill-inqas punt; ma komplewx b'≥ 400 copies/ml b'ta' RNA ta' HIV fl-aħħar vista Listi