FrancophonIA/ELRC3.0 huggingface dataset:
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 bi darunavir/cobicistat m'għandhiex tinbeda waqt it-tqala, u nisa li joħorġu tqal waqt it-terapija bi darunavir/cobicistat għandhom jinqalbu għal skeda alternattiva (ara sezzjonjiet 4.2 u 4.4).
English: Analyses of data through 96 weeks of treatment in the POWER trials demonstrated sustained antiretroviral efficacy and immunologic benefit.
Maltese: Analiżi tad-dejta matul is-96 ġimgħa ta' kura fil-provi POWER uriet effikaċja antiretrovirali u benefiċċju immunoloġiku li nżammu.
English: Endocrine disorders uncommon hypothyroidism, increased blood thyroid stimulating hormone
Maltese: Disturbi fis-sistema endokrinarja mhux komuni ipotirojdiżmu, żieda fl-ormon li jistimula it-tirojde fiddemm
English: C-darunavir with ritonavir showed that approximately 7.7% of the administered dose of darunavir is excreted in the urine unchanged.
Maltese: C-darunavir ma' ritonavir wera li bejn wieħed u ieħor 7.7% tad-doża ta' darunavir amministrata titneħħa fl-awrina mingħajr ma tinbidel.
English: The interaction profile of darunavir depends on whether ritonavir or cobicistat is used as pharmacokinetic enhancer.
Maltese: Il-profil ta' interazzjoni ta' darunavir jiddependi fuq jekk jintużax ritonavir bħala intensifikatur farmakokinetiku.
English: Concominant administration of darunavir with low dose ritonavir and lurasidone, pimozide or sertindole is contraindicated (see section 4.3).
Maltese: L-għoti fl-istess waqt ta' darunavir flimkien ma' doża baxxa ta' ritonavir u lurasidone, pimozide jew sertindole huwa kontraindikat (ara sezzjoni 4.3).
English: Some side effects are typical for anti-HIV medicines in the same family as Darunavir Krka.
Maltese: Xi effetti sekondarji huma tipiċi għall-mediċini kontra l-HIV li jagħmlu parti mill-familja ta' Darunavir Krka.
English: Pharmacokinetic results of total darunavir after administration of darunavir/ritonavir at 600/100 mg twice daily as part of an antiretroviral regimen, during the second trimester of pregnancy, the third trimester of pregnancy and postpartum
Maltese: Riżultati farmakokinetiċi ta' darunavir totali wara għoti ta' darunavir/ritonavir biddoża ta' 600/100 mg darbtejn kuljum bħala parti minn kors antiretrovirali terapewtiku, waqt it-tieni trimestru tat-tqala, it-tielet trimestru tat-tqala u wara ttwelid
English: If antidepressants are co-administered with darunavir with low dose ritonavir, the recommended approach is a dose titration of the antidepressant based on a clinical assessment of antidepressant response.
Maltese: Jekk jingħataw antidepressanti flimkien ma' darunavir intensifikat, il-mod li bih huwa rrakkomandat li dan għandu jsir huwa titrazzjoni tal-antidepressant abbażi ta' stima klinika tar-rispon tal-antidepressant.
English: For information on cobicistat pharmacokinetic properties, consult the cobicistat Summary of Product Characteristics.
Maltese: Għal aktar informazzjoni dwar cobicistat, fittex fis-Sommarju talKaratteristiċi tal-Prodott ta' cobicistat.
English: The recommended dose of emtricitabine/tenofovir alafenamide is 200/10 mg once daily when used with darunavir with low dose ritonavir.
Maltese: Id-doża rrakkomandata ta' emtricitabine/tenofovir alafenamide hija 200/10 mg darba kuljum meta jintuża ma' darunavir b'doża baxxa ta' ritonavir.
English: ARTEMIS
Maltese: Flecainide
English: Respiratory, thoracic and mediastinal disorders uncommon dyspnoea, cough, epistaxis, throat irritation rare rhinorrhoea
Maltese: Disturbi respiratorji, toraċiċi u medjastinali mhux komuni rari qtugħ ta' nifs, sogħla, epistassi, irritazzjoni filgerżuma rinorea
English: With baseline CD4+ cell count <
Maltese: 6/l ta' CD4+.
English: Resistance
Maltese: ANTIDEPRESSANTI
English: EU/1/17/1249/009 30 film-coated tablets EU/1/17/1249/010 90 film-coated tablets
Maltese: EU/1/17/1249/009 90 pillola miksijin b'rita:
English: Based upon the findings, the carbamazepine dose may need to be reduced by 25% to 50% in the presence of darunavir/ritonavir.
Maltese: Fuq bażi tas-sejbiet, id-doża ta' carbamazepine tista' tkun teħtieġ tnaqqis b'25% sa 50% filpreżenza ta' darunavir/ritonavir.
English: 800 mg film-coated tablets:
Maltese: 800 mg pilloli miksjin b'rita:
English: Darunavir must always be given orally with low dose ritonavir as a pharmacokinetic enhancer and in combination with other antiretroviral medicinal products.
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.
English: NARCOTIC ANALGESICS / TREATMENT OF OPIOID DEPENDENCE
Maltese: ANALĠEŻIĊI NARKOTIĊI/KURA TA' DIPENDENZA FUQ L-OPJOJDI
English: β-BLOCKERS Carvedilol Metoprolol Timolol
Maltese: Naloxegol biex tittratta stitikezza kkawżata mill-opiojdi
English: These active substances include e.g.: alfuzosin amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine astemizole, terfenadine colchicine when used in patients with renal and/or hepatic impairment (see section 4.5) ergot derivatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine) elbasvir/grazoprevir cisapride dapoxetine domperidone naloxegol lurasidone, pimozide, quetiapine, sertindole (see section 4.5) triazolam, midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5) sildenafil - when used for the treatment of pulmonary arterial hypertension, avanafil simvastatin, lovastatin and lomitapide (see section 4.5) dabigatran, ticagrelor (see section 4.5).
Maltese: methylergonovine) - elbasvir/grazoprevir - cisapride dapoxetine domperidone naloxegol - lurasidone, pimozide, quetiapine, sertindole (ara sezzjoni 4.5) - triazolam, midazolam mogħti mill-ħalq (għal attenzjoni dwar midazolam li jingħata b'mod parenterali, ara sezzjoni 4.5)
English: Brownish red, oval, biconvex film-coated tablets (tablets), engraved with a mark S3 on one side.
Maltese: Pilloli ħamor fil-kannella, b'forma ovali, bikonvessi, miksija b'rita (pilloli), imnaqqxa b'marka S3 fuq naħa waħda.
English: Darunavir Krka 400 mg film-coated tablets:
Maltese: Darunavir Krka 400 mg pilloli miksijin b'rita:
English: Darunavir Krka 800 mg film-coated tablets darunavir
Maltese: Darunavir Krka 800 mg pilloli miksijin b'rita darunavir
English: (CYP3A and/ or P-gp inhibition)
Maltese: (impediment ta' CYP3A u/jew ta' Pgp)
English: Boceprevir (hepatitis C infection)
Maltese: Saquinavir (infezzjoni bl-HIV).
English: Hence, concomitant use of darunavir coadministered with low dose ritonavir and the combination product lopinavir/ritonavir is contraindicated (see section 4.3).
Maltese: Għalhekk, l-użu konkomitanti ta' darunavir intensifikat u t-taħlita tal-prodott lopinavir/ritonavir hija kontraindikata (ara sezzjoni 4.3).
English: In the virologic failures of the ARTEMIS trial no cross-resistance with other PIs was observed.
Maltese: Fil-fallimenti viroloġiċi tal-prova ARTEMIS l-ebda reżistenza inkroċjata ma' PIs oħra ma kienet osservata.
English: The exposure to total darunavir and ritonavir after intake of darunavir/ritonavir 600/100 mg twice daily and darunavir/ritonavir 800/100 mg once daily as part of an antiretroviral regimen was generally lower during pregnancy compared with postpartum.
Maltese: L-esponiment għal darunavir u ritonavir totali wara t-teħid ta' darunavir/ritonavir 600/100 mg darbtejn kuljum u darunavir/ritonavir 800/100 mg darba kuljum bħala parti minn kors terapewtiku antiretrovirali kien ġeneralment inqas waqt it-tqala meta mqabbel ma' wara t-twelid.
English: Concomitant use of salmeterol and boosted darunavir is not recommended.
Maltese: L-użu konkomitanti ta' salmeterol u darunavir intensifikat mhuwiex irrakkomandat.
English: Other tablet strengths and formulations of darunavir are available.
Maltese: Hemm disponibbli qawwiet u formulalzzjonijiet oħra tal-pillola ta' darunavir.
English: Darunavir Krka might increase the risk for elevated potassium levels by drospirenone.
Maltese: Darunavir Krka jista' żżid irriskju tal-fsada.
English: This dose must not exceed the recommended adult dose, which is 600 milligram Darunavir Krka together with 100 milligram of ritonavir two times per day or 800 milligram Darunavir Krka together with 100 milligram ritonavir once a day.
Maltese: Din id-doża m'għandiex tkun aktar mid-doża rrakkomandata għall-adulti, li hija ta' 600 milligrama Darunavir Krka flimkien ma' 100 milligrama ritonavir darbtejn kuljum jew 800 milligramma Darunavir Krka flimkien ma' 100 milligramma ritonavir darba kuljum.
English: What Darunavir Krka looks like and contents of the pack Film-coated tablets (tablets) are orangish brown, oval, biconvex, engraved with a mark S2 on one side.
Maltese: Il-pilloli miksijin b'rita (pilloli) huma kannella fl-oranġjo, ovali, bikonvessi, imnaqqxa b'marka S2 fuq naħa waħda.
English: Adverse reactions observed with darunavir/cobicistat in adult patients
Maltese: Reazzjonijiet avversi osservati b'darunavir/cobicistat f'pazjenti adulti
English: Treatment with darunavir/cobicistat 800/150 mg during pregnancy results in low darunavir exposure (see sections 4.4 and 5.2).
Maltese: It-trattament b'darunavir/cobicistat 800/150 mg waqt it-tqala jwassal għal esponiment baxx għal darunavir (ara sezzjonijiet 4.4 u 5.2).
English: Metabolism and nutrition disorders common uncommon diabetes mellitus, hypertriglyceridaemia, hypercholesterolaemia, hyperlipidaemia gout, anorexia, decreased appetite, decreased weight, increased weight, hyperglycaemia, insulin resistance, decreased high density lipoprotein, increased appetite, polydipsia, increased blood lactate dehydrogenase
Maltese: gotta, anoreksja, tnaqqis fl-aptit, tnaqqis fil-piż, żieda fil-piż, ipergliċemija, reżistenza għallinsulina, tnaqqis fil-lipoproteina ta' densità għolja, żieda fl-aptit, polidipsja, żieda fil-lactate dehydrogenase fid-demm
English: There are currently inadequate data to determine whether co-administration of tenofovir disoproxil and cobicistat is associated with a greater risk of renal adverse reactions compared with regimens that include tenofovir disoproxil without cobicistat.
Maltese: Bħalissa m'hemmx dejta adegwata biex tistma jekk l-għoti flimkien ta' tenofovir disoproxil u cobicistat huwiex assoċjat ma' riskju akbar ta' reazzjonijiet avversi filkliewi meta mqabbla ma' skedi li jinkludu tenofovir disoproxil mingħajr cobicistat.
English: Therefore, darunavir must only be used in combination with a pharmacokinetic enhancer (see sections 4.4 and 5.2).
Maltese: Għalhekk darunavir għandu jintuża biss flimkien ma' intensifikatur farmakokinetiku (ara sezzjonijiet 4.4 u 5.2).
English: Orangish brown, oval, biconvex film-coated tablets, engraved with a mark S2 on one side.
Maltese: Pilloli miksijin b'rita kannella fl-oranġjo, ovali, bikonvessi, imnaqqxa b'marka S2 fuq naħa waħda.
English: Limited data is available in patients with HIV-1 clades other than B.
Maltese: Hija disponibbli dejta limitata f'pazjenti bi grupp ta'virusis HIV-1 ġejjin mill-istess antenat li mhumiex B.
English: No dose adjustment is required for darunavir/ritonavir in patients with renal impairment (see sections 4.4 and 5.2).
Maltese: Ma hemm bżonn l-ebda aġġustament tad-doża għal darunavir/ritonavir f'pazjenti b'indeboliment renali (ara sezzjonijiet 4.4 u 5.2).
English: For clinical trial results in ART-naïve paediatric patients aged 12 to 17 years, refer to the Summary of Product Characteristics for Darunavir Krka 400 mg and 800 mg tablets.
Maltese: Għar-riżultati mill-provi kliniċi f'pazjenti pedjatriċi bejn it-12 sa 17-il sena li ma ngħatawx kura b'ART, irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott għal Darunavir Krka pilloli ta' 400 mg u 800 mg.
English: At the highest tested doses, the systemic exposures (based on AUC) to darunavir were between 0.4- and 0.7-fold (mice) and 0.7- and 1-fold (rats), relative to those observed in humans at the recommended therapeutic doses.
Maltese: Flogħla dożi ittestjati, l-esponimenti sistemiċi (ibbażati fuq l-AUC) għal darunavir kienu bejn 0.4 darbiet u 0.7 darbiet (ġrieden) u 0.7 darbiet u darba aktar (fil-firien) meta mqabbla ma' dawk osservati fil-bnedmin fid-dożi terapewtiċi rrakkomandati.
English: The pharmacokinetics of darunavir in combination with ritonavir taken once daily in 12 ART-naïve paediatric patients, aged 12 to < 18 years and weighing at least 40 kg, showed that darunavir /ritonavir 800/100 mg once daily results in darunavir exposure that was comparable to that achieved in adults receiving darunavir /ritonavir 800/100 mg once daily.
Maltese: Il-farmakokinetiċi ta' darunavir flimkien ma' ritonavir li ttieħed darbta kuljum fi 12-il-pazjent pedjatriku mhux ikkurati b'ART, ta' bejn 12 sa < 18-il sena u li kienu jiżnu mill-inqas 40 kg, urew li darunavir/ritonavir 800/100 mg darba kuljum irriżulta f'esponiment għal darunavir li kien komparabbli ma dak miksub f'adulti li rċevew darunavir/ritonavir 800/100 mg darba kuljum.
English: Repeated administration of darunavir to rats caused hepatic microsomal enzyme induction and increased thyroid hormone elimination, which predispose rats, but not humans, to thyroid neoplasms.
Maltese: L-amministrazzjoni ripetuta ta' darunavir lill-firien ikkawżat induzzjoni tal-enzimi epatiċi mikrosomali u żiedet l-eliminazzjonni tal-ormon tat-tirojde, li jippredisponi lill-firien, iżda mhux lill-bnedmin, għal neoplażmi tat-tirojde.
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: Darunavir contains a sulphonamide moiety.
Maltese: - Dejjem ħu Darunavir Krka flimkien ma' ritonavir.
English: Bottle (HDPE), child resistant temper evident PP closure with a desiccant: - 30 tablets: 1 bottle of 30 film-coated tablets, - 60 tablets: 2 bottles of 30 film-coated tablets, - 90 tablets: 3 bottles of 30 film-coated tablets, - 180 tablets: 6 bottles of 30 film-coated tablets.
Maltese: 2 fliexken ta' 30 pillola miksijin b'rita, 90 pillola: 3 fliexken ta' 30 pillola miksijin b'rita, 180 pillola: 6 fliexken ta' 30 pillola miksijin b'rita.
English: ODIN is a Phase III, randomised, open-label trial comparing darunavir/ritonavir 800/100 mg once daily versus darunavir/ritonavir 600/100 mg twice daily in ART-experienced HIV-1 infected patients with screening genotype resistance testing showing no darunavir RAMs (i.e. V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V) and a screening HIV-1 RNA > 1,000 copies/ml.
Maltese: Il-pilloli Darunavir Krka 400 mg u 800 mg jistgħu jintużaw biex jipprovdu skedi ta' għoti ta' dożi xierqa għat-trattament ta' infezzjoni ta' HIV-1 f'pazjenti adulti u pedjatriċi minn età ta' 3 snin u b'tal-anqas 40 kg ta' piż tal-ġisem li: - qatt ma ħadu kura b'antiretrovirali (ART), qabel (ara sezzoni 4.2). - jkunu diġà ħadu ART mingħajr ma jkollhom mutazzjonijiet assoċjati ma' reżistenza għal darunavir (DRV-RAMs) u li għandhom < 100,000 kopja/ml ta' HIV-1 RNA u għadd ta' ċelluli CD4+ ≥ 100 ċelluli x 106/l fil-plażma.
English: No new safety findings were identified in the 192 week analysis of the treatment-naïve subjects in which the mean treatment duration of darunavir/ritonavir 800/100 mg once daily was 162.5 weeks.
Maltese: Ma ġewx identifikati sejbiet oħra ta' sigurtà fil-192 ġimgħa ta' analiżi f'individwi li qatt ma ħadu kura qabel li kellhom medja ta' tul ta' kura b'darunavir/ritonavir 800/100 mg darba kuljum ta' 162.5 ġimgħat.
English: Each film-coated tablet contains 800 mg darunavir.
Maltese: Kull pillola miksija b'rita fiha 800 mg darunavir.
English: ART-experienced paediatric patients (3 to 17 years of age and weighing at least 40 kg)
Maltese: Pazjenti pedjatriċi li ma ħadux kura b'ART (3 snin sa 17-il sena u li jiżnu anqas minn 40 kg)
English: Out of the 59 patients who responded with complete viral suppression (< 50 copies/ml) at week 48, 47 patients (80% of the responders at week 48) remained responders at week 96.
Maltese: Mill-59 pazjenti li rrispondew b'suppressjoni virali kompleta (< 50 kopja/ml ) fit-48 ġimgħa, 47 pazjent (80% ta' dawk li rrispondew fit-48 ġimgħa) baqgħu jirrispondu fis-96 ġimgħa.
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, lAUC24h u s- Cmin ta' darunavir totali kienu 37%, 50% u 89% aktar baxxi rispettivament, meta mqabbla ma' wara t-twelid.
English: Clinical monitoring for central nervous system toxicity associated with increased exposure to efavirenz may be indicated when darunavir coadministered with low dose ritonavir is given in combination with efavirenz.
Maltese: Fil-kelb, l-ebda sejbiet ta' tossiċità maġġuri jew organi mimsusa ma' kienu identifikati sa esponimenti ekwivalenti għal esponiment kliniku fid-doża rrakkomandata.
English: (CYP3A and/or P-gp inhibition)
Maltese: (inibizzjoni ta' CYP3A u/jew P-gp)
English: Gastrointestinal disorders very common diarrhoea common vomiting, nausea, abdominal pain, increased blood amylase, dyspepsia, abdominal distension, flatulence uncommon pancreatitis, gastritis, gastrooesophageal reflux disease, aphthous stomatitis, retching, dry mouth, abdominal discomfort, constipation, increased lipase, eructation, oral dysaesthesia rare stomatitis, haematemesis, cheilitis, dry lip, coated tongue
Maltese: Disturbi gastrointestinali komuni ħafna komuni mhux komuni dijarea, nawsja rimettar, uġigħ fl-addome, nefħa fl-addome, dispepsja, gass, żieda fil-livell tal-enzimi tal-frixa pankreatite akuta
English: Patients with pre-existing liver dysfunction, including chronic active hepatitis B or C, have an increased risk for liver function abnormalities including severe and potentially fatal hepatic adverse reactions.
Maltese: Pazjenti li diġà kellhom disfunzjoni tal-fwied qabel, li jinkludu dawk b'epatite B jew Ċ kronika attiva, għandhom riskju akbar ta' anormalitajiet fil-funzjoni tal-fwied li jinkludu reazzjonijiet epatiċi avversi qawwija u li jistgħu jkunu fatali.
English: The effects on co-administered medicinal products may thus be underestimated and clinical monitoring o safety may be indicated.
Maltese: L-effetti fuq prodotti mediċinali mogħtija flimkien jista' għalhekk ikun stmat anqas milli veru huwa u jista' jkun indikat monitoraġġ kliniku tas-sigurtà.
English: Boosted darunavir may increase the exposure to grazoprevir.
Maltese: Darunavir intensifikat jista' jżid lesponiment għal grazoprevir.
English: darunavir/ ritonavir darunavir/ ritonavir 800/100 mg darunavir/ ritonavir darunavir/ ritonavir 600/100 mg
Maltese: L-użu ta' darunavir/ritonavir u darunavir/cobicistat flimkien ma' lopinavir/ritonavir,
English: 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, zoldipem (sedative agents)
Maltese: Rifabutin (kontra infezzjonijiet batterjali) - Sildenafil, vardenafil, tadalafil(għal anormalità erettili jew pressjonigħolja 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' uġigħ fin-nervituri) Colchicine (biex tikkura l-gotta jew deni Mediterranju familjali) Bosentan (biex tikkura pressjoni għolja fiċ-ċirkolazzjoni tal-pulmuni) - Buspirone, clorazepate, diazepam, estazolam, flurazepam, midazolam meta jintuża bħala injezzjoni, zoldipem (sustanzi sedattivi) Perphenazine, risperidone, thioridazine (biex tikkura kundizzjonijiet psikjatriċi).
English: Isolates with baseline FC ≤ 10 are susceptible; isolates with FC > 10 to 40 have decreased susceptibility; isolates with FC > 40 are resistant (see Clinical results).
Maltese: Iżolati bil-linja bażi ta' FC ≤ 10 huma suxxettibbli; iżolati b' FC > 10 sa 40 għandhom suxxettibiltà mnaqqsa, iżolati b'FC > 40 huma reżistenti (ara Riżultati kliniċi).
English: Breast-feeding
Maltese: TAL-PLEJTLITS
English: The use of carbamazepine with darunavir co-administered with cobicistat is contraindicated (see section 4.3).
Maltese: L-użu ta' carbamazepine ma' darunavir mogħti flimkien ma' cobicistat huwa kontraindikat (ara sezzjoni 4.3).
English: Based on theoretical considerations boosted darunavir may increase the exposure to glecaprevir and pibrentasvir.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi darunavir intensifikat jista' jżid ilkonċentrazzjonijiet ta' dawn lanalżeġiċi fil-plażma.
English: Changes were observed in liver (hepatocyte hypertrophy, vacuolation, increased liver enzymes) and thyroid (follicular hypertrophy).
Maltese: Bidliet ġew osservati fil-fwied (ipertrofija tal-epatoċiti, vakwolazzjoni, żieda flenzimi tal-fwied) u t-tirojde (ipertrofija follikulari).
English: St John's wort is expected to decrease the plasma concentrations of darunavir or its pharmacoenhancers.
Maltese: St John's wort huwa mistenni li jnaqqas ilkonċentrazzjonijiet ta' darunavir jew ilfarmakointensifkaturi tiegħu filplażma.
English: Each film-coated tablet contains 400 mg or 800 mg darunavir.
Maltese: Kull pillola miksija b'rita fiha 400 mg jew 800 mg darunavir.
English: For additional clinical study results in ART-experienced adults and paediatric patients, refer to the Summary of Product Characteristics for Darunavir Krka 600 mg tablets.
Maltese: Għal riżultati addizzjonali ta' studji kliniċi f'pazjenti adulti u pedjatriċi li digà ħadu ART, ara s-Sommarju ta' Karatterisiċi tal-Prodott għal Darunavir Krka pilloli ta' 600 mg.
English: During the clinical development program of raltegravir in treatment-experienced patients, rash, irrespective of causality, was more commonly observed with regimens containing darunavir/ritonavir + raltegravir compared to those containing darunavir/ritonavir without raltegravir or raltegravir without darunavir/ritonavir.
Maltese: M'hemm bżonn tal-ebda prekawzjonijiet speċjali jew aġġustament tad-doża għal darunavir/ritonavir f'pazjenti b'indeboliment renali.
English: Yellowish brown, oval, biconvex film-coated tablets (tablets), engraved with a mark S1 on one side.
Maltese: Pilloli kannella fl-isfar, b'forma ovali, bikonvessi, miksija b'rita (pilloli), imnaqqxa b'marka S1 fuq naħa waħda.
English: At 48 weeks, virologic response, defined as the percentage of patients with plasma HIV-1 RNA level < 50 copies/ml, with darunavir/ritonavir 800/100 mg once daily treatment was demonstrated to be non-inferior (at the pre-defined 12% non-inferiority margin) compared to darunavir/ritonavir 600/100 mg twice daily for both ITT and OP populations.
Maltese: Fil-ġimgħa 48, rispons viroloġiku ddefinit bħala l-perċentwal ta' pazjenti b'livell ta' HIV-1 RNA < 50 kopja/ml fil-plażma, b'darunavir/ritonavir 800/100 mg darba kuljum intwera li ma kienx inferjuri (bil-marġini ta' non-inferjorità ta' 12% ddefiniti minn qabel) meta mqabbel ma' darunavir/ritonavir 600/100 mg darbtejn kuljum kemm għall-popolazzjonijiet ITT kif ukoll OP.
English: The use of these medicines with darunavir/cobicistat is contraindicated (see section 4.3).
Maltese: L-użu ta' dawn il-mediċini ma' darunavir/cobicistat huwa kontraindikat (ara sezzjoni 4.3).