FrancophonIA/ELRC3.0 huggingface dataset:
English: Further information on Rubraca can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Rubraca.
Maltese: ema.europa.eu/medicines/human/EPAR/Rubraca.
English: This overview was last updated in 02-2019.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar fi 02-2019.
English: Rubraca received a conditional marketing authorisation valid throughout the EU on 24 May 2018.
Maltese: Rubraca rċieva awtorizzazzjoni kkundizzjonata għat-tqegħid fis-suq valida fl-UE fl-24 ta' Mejju 2018.
English: Rubraca contains the active substance rucaparib.
Maltese: Rubraca fih is-sustanza attiva rukaparib.
English: The most common side effects with Rubraca (which may affect more than 1 in 5 people) are tiredness or weakness, nausea (feeling sick), increased levels of creatinine (which may indicate kidney problems) and liver enzymes in the blood (which may indicate liver damage), vomiting, anaemia (low red blood cell counts), decreased appetite, dysgeusia (taste disturbances), diarrhoea, thrombocytopenia (low levels of platelets) and abdominal pain (belly ache).
Maltese: L-effetti sekondarji l-aktar komuni b'Rubraca (li jistgħu jaffettwaw aktar minn 1 minn kull 5) huma għeja jew dgħufija, dardir (tħossok ma tiflaħx), żieda fil-livelli tal-kreatinina (li tista' tindika problemi fil-kliewi) u tal-enzimi tal-fwied fid-demm (li tista' tindika ħsara fil-fwied), rimettar, anemija (għadd baxx taċ-ċelloli ħomor tad-demm), tnaqqis fl-aptit, disgewżja (disturbi fit-togħma), dijarea, tromboċitopenja (livelli baxxi tal-pjastrini) u wġigħ addominali (uġigħ ta' żaqq).
English: Other information about Rubraca
Maltese: Informazzjoni oħra dwar Rubraca
English: What are the risks associated with Rubraca?
Maltese: X'inhuma r-riskji assoċjati ma' Rubraca?
English: The recommended dose of Rubraca is 600 mg twice a day.
Maltese: Id-doża rrakkomandata ta' Rubraca hija ta' 600 mg darbtejn kuljum.
English: Rubraca is a cancer medicine for treating high-grade cancers of the ovary, fallopian tubes (the tubes connecting ovaries to the uterus) and the peritoneum (the membrane lining the abdomen).
Maltese: Rubraca huwa mediċina kontra l-kanċer biex tikkura kanċers ta' grad għoli tal-ovarji, tat-tubi fallopjani (it-tubi li jgħaqqdu l-ovarji mal-utru) u tal-peritonew (il-membrana li tiksi l-addome).
English: Rubraca as maintenance treatment was investigated in a study of 564 patients with ovarian cancer which had cleared (partially or completely) after treatment with platinum-based cancer medicines.
Maltese: Rubraca bħala kura ta' manteniment ġie investigat fi studju ta' 564 pazjent b'kanċer tal-ovarji li kien tneħħa (parzjalment jew kompletament) wara kura b'mediċini kontra l-kanċer ibbażati fuq il-platinu.
English: The active substance in Rubraca, rucaparib, blocks the activity of a family of proteins called poly(ADPribose) polymerases (PARPs) that help to repair damaged DNA in cells (both normal and cancer cells).
Maltese: Is-sustanza attiva f'Rubraca, ir-rukaparib, timblokka l-attività ta' familja ta' proteini msejħa polimerażijiet poli(ADP-ribose) (PARPs) li jgħinu biex isewwu DNA bi ħsara fiċ-ċelloli (kemm ċelloli normali kif ukoll tal-kanċer).
English: What information is still awaited for Rubraca?
Maltese: Liema informazzjoni għadha mistennija għal Rubraca?
English: Of the 79 patients whose disease had responded in the past to platinumbased medicines, 65% (51 patients) had a response to treatment with Rubraca and the response lasted on average 294 days (around 10 months).
Maltese: Mid-79 pazjent li l-marda tagħhom fil-passat kienet irrispondiet għal mediċini bbażati fuq il-platinu, 65 % (51 pazjent) kellhom rispons għal kura b'Rubraca u r-rispons dam bħala medja għal 294 jum (madwar 10 xhur).
English: Since Rubraca has been given conditional authorisation, the company that markets the medicine will provide the results from an ongoing study comparing Rubraca with chemotherapy (another cancer medicine) in patients with high-grade epithelial cancer of the ovary, of the fallopian tubes or of the peritoneum with BRCA mutation whose cancer has come back after chemotherapy treatments.
Maltese: Minħabba li Rubraca ngħata awtorizzazzjoni kkundizzjonata, il-kumpanija li tqiegħed il-mediċina fis-suq se tipprovdi r-riżultati minn studju li għadu għaddej li jqabbel Rubraca mal-kimoterapija (mediċina talkanċer oħra) f'pazjenti b'kanċer epiteljali ta' grad għoli tal-ovarju, tat-tubi fallopjani jew tal-peritonew b'mutazzjoni BRCA li l-kanċer tagħhom irritorna wara kuri bil-kimoterapija.
English: The company will also provide further data on maintenance treatment, including data on how long patients survived with Rubraca.
Maltese: Il-kumpanija se tipprovdi wkoll data ulterjuri dwar il-kura ta' manteniment, inkluż data dwar kemm damu ħajjin il-pazjenti b'Rubraca.
English: Two other studies looked at 106 patients with ovarian cancer and BRCA mutation whose cancer had come back following at least 2 previous cancer treatments, including in many cases treatment with platinum-based medicines.
Maltese: Żewġ studji oħra ħarsu lejn 106 pazjenti b'kanċer tal-ovarji u b'mutazzjoni BRCA li l-kanċer tagħhom kien irritorna wara tal-inqas 2 kuri għall-kanċer preċedenti, inkluż f'ħafna każijiet kura b'mediċini bbażati fuq il-platinu.
English: For the full list of side effects of Rubraca, see the package leaflet.
Maltese: Aktar informazzjoni fuq Rubraca tinstab fis-sit web tal-Aġenzija:
English: For such patients, tests for a genetic mutation (BRCA mutation) should be carried out first to see if Rubraca is likely to work for them.
Maltese: Dan il-benefiċċju deher f'pazjenti bi jew mingħajr il-mutazzjoni BRCA.
English: For maintenance treatment, Rubraca should be used no later than 8 weeks after the patient has finished their treatment with platinum-based medicine.
Maltese: Għal kura ta' manteniment, Rubraca għandu jintuża mhux aktar tard minn 8 ġimgħat wara li l-pazjent ikun temm il-kura tiegħu b'mediċina bbażata fuq il-platinu.
English: As for all medicines, data on the use of Rubraca are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Rubraca hija ssorveljata kontinwament.
English: EMA/637201/2014 EMEA/H/C/000254
Maltese: EMEA/H/C/000254
English: The full EPAR for Renagel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is available as tablets (400 and 800 mg).
Maltese: Jiġi bħala pilloli (400 u 800 mg).
English: Renagel sevelamer hydrochloride
Maltese: Renagel sevelamer kloridrat
English: The second, which did not compare Renagel with any other medicines, included 172 patients.
Maltese: Fit-tieni studju, li ma qabbilx Renagel ma' mediċini oħra, inkluda 172 pazjent.
English: This is a summary of the European public assessment report (EPAR) for Renagel.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Renagel.
English: In the study of patients undergoing peritoneal dialysis, the patients receiving Renagel had similar falls in phosphate as the patients receiving calcium acetate (0.52 and 0.58 mmol/l, respectively).
Maltese: Fl-istudju ta' pazjenti li kienu qed jagħmlu d-dijaliżi peritoneali, il-pazjenti li kienu qed jirċievu Renagel kellhom tnaqqis fil-livelli tal-fosfat simili għal dawk li kienu qed jirċievu l-kalċju aċetat (0.52 u 0.58 mmol/l, rispettivament).
English: The recommended starting dose of Renagel depends on the level of phosphate in the blood and ranges from 800 to 1,600 mg three times a day.
Maltese: Id-doża inizjali rakkomandata ta' Renagel tiddependi mil-livell ta' fosfat fid-demm u tvarja bejn 800 u 1,600 mg tliet darbiet kuljum.
English: In the third, there was an average fall of 0.71 mmol/l over 44 weeks.
Maltese: Fit-tielet studju kien hemm tnaqqis medju ta' 0.71 mmol/l fuq perjodu ta' 44 ġimgħa.
English: In the comparative study of patients undergoing haemodialysis, there was an average fall of 0.65 mmol/l over the eight weeks of Renagel treatment, compared with 0.68 mmol/l when the patients were taking calcium acetate.
Maltese: Fl-istudju kumparattiv ta' pazjenti li għaddejjin minn emodijaliżi, ġie irreġistrat tnaqqis medju ta' 0.65 mmol/l fuq il-perjodu ta' tmien ġimgħat tat-trattament b'Renagel, meta mqabbla ma' 0.68 mmol/l meta l-pazjenti kienu qed jieħdu l-kalċju aċetat.
English: Renagel is used to control hyperphosphataemia (high blood phosphate levels) in adults on dialysis (a blood clearance technique used in patients with kidney disease).
Maltese: Renagel jintuża fil-kontroll tal-iperfosfatemija (livelli għoljin ta' fosfat fid-demm) f'adulti bid-dialiżi (teknika tat-tisfija tad-demm użata f'pazjenti b'mard fil-kliewi).
English: Renagel is a medicine that contains the active substance sevelamer hydrochloride.
Maltese: Renagel huwa mediċina li fiha s-sustanza attiva sevelamer kloridrat (sevelamer hydrochloride).
English: Why has Renagel been approved?
Maltese: Għaliex ġie approvat Renagel?
English: The active substance in Renagel, sevelamer hydrochloride, is a phosphate binder.
Maltese: Issustanza attiva f'Renagel, is-sevelamer kloridat, teħel mal-fosfat.
English: What is Renagel?
Maltese: X'inhu Renagel?
English: For the full list of all side effects reported with Renagel, see the package leaflet.
Maltese: Għal-lista sħiħa ta' effetti sekondarji rrappurtati b'Renagel, ara l-fuljett ta' tagħrif.
English: A risk management plan has been developed to ensure that Renagel is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Renagel jintuża bl-aktar mod sigur possibbli.
English: The dose of Renagel should be adjusted to ensure that the blood phosphate level stays below 1.76 mmol/l.
Maltese: Id-dożaġġ ta' Renagel għandu jkun aġġustat biex jassigura li l-livelli ta' fosfat fid-demm jibqgħu anqas minn 1.76 mmol/l.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Renagel on 28 January 2000.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Renagel fit-28 ta' Jannar 2000.
English: The first study compared Renagel with calcium acetate (another phosphate-lowering medicine) in 84 patients.
Maltese: L-ewwel studju qabbel Renagel mal-kalċju aċetat (calcium acetate, mediċina oħra li tbaxxi l-livell tal-fosfat) f'84 pazjent.
English: In haemodialysis, Renagel has been studied in two short-term studies lasting eight weeks and one longer study lasting 44 weeks.
Maltese: Fl-emodijaliżi, Renagel ġie studjat f'żewġ studji b'terminu ta' żmien qasir li damu 8 ġimgħat u wieħed itwal li dam 44 ġimgħa.
English: How has Renagel been studied?
Maltese: Kif ġie studjat Renagel?
English: What is the risk associated with Renagel?
Maltese: X'inhuma r-riskji assoċjati ma' Renagel?
English: Patients taking Renagel had a similar fall in phosphate levels in the second study.
Maltese: Il-pazjenti li kienu qed jieħdu Renagel kellhom tnaqqis simili tal-livelli ta' fosfat fit-tieni studju.
English: Renagel produced a significant decrease in serum phosphate in all of the studies.
Maltese: Renagel wassal għal tnaqqis sinifikanti tal-livelli tas-serum ta' fosfat fl-istudji kollha.
English: In peritoneal dialysis, there has been one study comparing Renagel with calcium acetate in 143 patients over 12 weeks.
Maltese: Fid-dijaliżi peritoneali, kien hemm biss studju wieħed ta' Renagel li qabbel l-effikaċja tiegħu ma' dik talkalċju aċetat f'143 pazjent fuq perjodu ta' 12-il ġimgħa.
English: The most common side effects with Renagel (seen in more than 1 patient in 10) are nausea (feeling sick) and vomiting.
Maltese: L-effetti sekondarji l-aktar komuni b'Renagel (li dehru f'aktar minn pazjent 1 minn 10) huma nawżja (dardir) u remettar.
English: It can be used in patients undergoing haemodialysis (dialysis using a blood filtration machine) or peritoneal dialysis (where fluid is pumped into the abdomen and an internal body membrane filters the blood).
Maltese: Jista' jintuża f'pazjenti li jagħmlu lemodijaliżi (bl-użu ta' magna li tiffiltra d-demm) jew dijaliżi peritoneali (fejn il-fluwidu jiġi ppumpjat fiż-żaqq u d-demm jiġi ffiltrat permezz ta' membrana ġol-ġisem).
English: The CHMP decided that Renagel's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Renagel huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: List of the names, pharmaceutical forms, strength of the medicinal product, route of administration, marketing authorisation holder in the Member States
Maltese: Lista ta` ismijiet, għamliet farmaċewtiċi, qawwa tal-prodott mediċinali, mnejn jingħata, id-detentur ta` l-awtorizzazzjoni għat-tqegħid fis-suq flistati membri
English: Goserelin Novosis 3,6 mg Implantat implant, pre-filled syringe subcutaneous use
Maltese: Goserelin Novosis 3,6 mg Implantat impjant, siringa mimlija għal-lest
English: United Kingdom Acino AG Am Windfeld 35
Maltese: Ir-Renju Unit
English: 83714 Miesbach
Maltese: Mnejn jingħata
English: 50 ml (10 mg/ml) 1 vial
Maltese: Numru tal-EMA Isem (ivvintat) Qawwa Għamla farmaċewtika
English: EMA Number
Maltese: Mnejn għandu jingħata
English: Date of opening:____________
Maltese: Data tal-ftuħ:____________
English: TAD Pharma GmbH Heinz-Lohmann-Straße 5 27472 Cuxhaven Germany
Maltese: TAD Pharma GmbH Heinz-Lohmann-Straße 5 27472 Cuxhaven
English: Systemic lidocaine, Quinidine
Maltese: Amiodarone, Systemic lidocaine, Quinidine
English: 25-O-desacetyl-rifabutin AUC 25-O-desacetyl-rifabutin cmax 25-O-desacetyl-rifabutin cmin
Maltese: AUC ta' 25-O-desacetyl-rifabutin cmax ta' 25-O-desacetyl-rifabutin cmin ta' 25-O-desacetyl-rifabutin
English: Capsule contents lactose monohydrate crospovidone (type A) magnesium stearate
Maltese: Kontenut tal-kapsula lactose monohydrate crospovidone (tip A) magnesium stearate
English: Per protocol analysise
Maltese: Analiżi skont il protokolle
English: Desacetyl-diltiazem AUC ↑165% Desacetyl-diltiazem cmax ↑172% Desacetyl-diltiazem cmin ↑121%
Maltese: cmax ta' Desacetyl-diltiazem ↑172 % cmin ta' Desacetyl-diltiazem ↑121 %
English: КРКА България ЕООД Teл.
Maltese: България КРКА България ЕООД
English: Sofosbuvir 400 mg / velpatasvir 100 mg /voxilaprevir 100 mg single dose*
Maltese: Sofosbuvir 400 mg / velpatasvir 100 mg /voxilaprevir 100 mg doża waħda*
English: The M184I/V substitution emerged in 5/26 atazanavir /ritonavir and 7/26 lopinavir/ritonavir virologic failure patients, respectively.
Maltese: Is-sostituzzjoni ta' M184I/V ħarġet f'5/26 atazanavir/ritonavir u 7/26 pazjenti lopinavir/ritonavir/viroloġiċi li fallew, rispettivament.
English: ANTI-RETROVIRALS
Maltese: ANTIRETROVIRALI
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1353/003 30 hard capsules EU/1/19/1353/004 90 (3 x 30) hard capsules
Maltese: EU/1/19/1353/003 30 kapsula iebsa EU/1/19/1353/004 90 (3 x 30) kapsula iebsa
English: Each hard capsule contains 79.43 mg lactose monohydrate.
Maltese: Kull kapsula iebsa fiha 79.43 mg lactose monohydrate.
English: Time-averaged difference ATV/RTV-LPV/RTV [97.5% CI d]
Maltese: LPV/RTV [97.5 % CId]
English: Capsule contents: lactose monohydrate, crospovidone (type A) and magnesium stearate.
Maltese: Kontenut tal-kapsula: lactose monohydrate. crospovidone (tip A) u magnesium stearate.
English: Table 2: Interactions between atazanavir and other medicinal products Medicinal products by therapeutic area
Maltese: Tabella 2: Interazzjonijiet bejn atazanavir u prodotti mediċinali oħra
English: The proportion of patients with HIV RNA < 400 copies/ml were 53% and 43% for ATV/RTV and 54% and 46% for LPV/RTV at weeks 48 and 96 respectively.
Maltese: <400 kopja/ml kienu 53 % u 43 % għal ATV/RTV u 54 % u 46 % għal LPV/RTV fil-ġimgħat 48 u 96 rispettivament.
English: Each hard capsule contains 158.86 mg lactose monohydrate.
Maltese: Kull kapsula iebsa fiha 158.86 mg ta' lactose monohydrate.
English: Atazanavir Krka contains lactose monohydrate
Maltese: Krka fih lactose monohydrate
English: atazanavir AUC ↓ 35% atazanavir cmax ↓ 25% atazanavir cmin ↓ 49%
Maltese: atazanavir AUC ↓ 35% cmax ta' atazanavir ↓ 25% cmin ta' atazanavir ↓ 49%
English: (n=90
Maltese: (n=90e)
English: Difference estimate [95% CI]
Maltese: Stima tad-differenza [95% CI]d
English: Cmin ng/mLb
Maltese: Cmax ng/mL
English: Norbuprenorphine AUC ↑105% Norbuprenorphine cmax ↑61% Norbuprenorphine cmin ↑101%
Maltese: AUC ta' Norbuprenorphine ↑105 % cmax ta' Norbuprenorphine ↑61 % cmin ta' Norbuprenorphine ↑101 %
English: Frequency de novo PI substitution (n=35)a,b M36, M46, I54, A71, V82 L10, I15, K20, V32, E35, S37, F53, I62, G73, I84, L90
Maltese: Frekwenza de novo PI sostituzzjoni (n=35)a,b M36, M46, I54, A71, V82 L10, I15, K20, V32, E35, S37, F53, I62, G73, I84, L90
English: Buprenorphine AUC ↑67% Buprenorphine cmax ↑37% Buprenorphine cmin ↑69%
Maltese: AUC ta' Buprenorphine ↑67 % cmax ta' Buprenorphine ↑37 % cmin ta' Buprenorphine ↑69%
English: boceprevir AUC ↔5% boceprevir cmax ↔7% boceprevir cmin ↔18%
Maltese: AUC ta' Boceprevir ↔5% cmax ta' Boceprevir ↔7% cmin ta' Boceprevir ↔18%
English: 400 mg with ritonavir 100 mg with TDM may be considered (see sections 4.6 and 5.2).
Maltese: Krka 400 mg ma' ritonavir 100 mg b'TDM (ara sezzjonijiet 4.6 u 5.2).
English: Atazanavir, simultaneous administration with ddI+d4T (fasted)
Maltese: Atazanavir, iddożat siegħa wara ddI+d4T (fi stat sajjem)
English: Body: titanium dioxide (E171) and gelatine
Maltese: Korp: titanium dioxide (E171) u gelatine
English: Clarithromycin AUC ↑94% (↑75% Clarithromycin cmax ↑50% (↑32% Clarithromycin cmin ↑160%
Maltese: AUC ta' Clarithromycin ↑94 % cmax ta' Clarithromycin ↑50% (↑32% cmin ta' Clarithromycin ↑160 %
English: Voriconazole AUC ↑561% Voriconazole cmax ↑438% (↑355% Voriconazole cmin ↑765% (↑571%
Maltese: AUC ta' Voriconazole ↑561 % cmax ta' Voriconazole ↑438 % (↑355 % cmin ta' Voriconazole ↑765 % (↑571 %
English: c PI major L24I, D30N, V32I, L33F, M46IL, I47AV, G48V, I50LV, F53LY, I54ALMSTV, L76V, V82AFLST, I84V,
Maltese: L24I, D30N, V32I, L33F, M46IL, I47AV, G48V, I50LV, F53LY, I54ALMSTV, L76V, V82AFLST, I84V,
English: f,g
Maltese: (e.ż.,
English: 14-OH clarithromycin cmax ↓72% 14-OH clarithromycin cmin ↓62%
Maltese: AUC ta' 14-OH clarithromycin ↓70 % cmax ta' 14-OH clarithromycin ↓72 % cmin ta' 14-OH clarithromycin ↓62 %
English: G73, V82, I84, and L90 (0-2, 3, 4 or more) at baseline.
Maltese: L63, A71, G73, V82, I84, u L90 (0-2, 3, 4 jew aktar) fil-linja bażi.
English: Rifabutin AUC ↑48% (↑19% Rifabutin cmax ↑149% (↑103% Rifabutin cmin ↑40% (↑5% ↑87%)
Maltese: AUC ta' Rifabutin ↑48 % (↑19 % cmax ta' Rifabutin ↑149 % (↑103 % cmin ta' Rifabutin ↑40 % (↑5 % ↑87 %)
English: Nevirapine AUC ↑26% (↑17% Nevirapine cmax ↑21% (↑11% Nevirapine cmin ↑35% (↑25%
Maltese: AUC ta' Nevirapine ↑26 % (↑17 % cmax ta' Nevirapine ↑21 % (↑11 % cmin ta' Nevirapine ↑35 % (↑25 %
English: Other marked clinical laboratory abnormalities (Grade 3 or 4) reported in ≥ 2% of patients receiving regimens containing atazanavir and one or more NRTIs included: elevated creatine kinase (7%), elevated alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/SGPT) (5%), low neutrophils (5%), elevated aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT) (3%), and elevated lipase (3%).
Maltese: Anormalitajiet oħra tal-laboratorju (Grad 3 jew 4) li ġew irrapportati f'≥2 % tal-pazjenti li jirċievu lkura b' atazanavir flimkien ma' NRTI wieħed jew iżjed inkludew: kreatina kinasi elevata (7 %), serum aminotransferasi/glutamikpiruvik transaminasi elevata (ALT/SGPT) (5 %), newtrofili baxxi (5 %), serum aspartate aminotransferasi/glutamic-oxaloacetic transaminasi (AST/SGOT) (3 %) u lipadosi elevati (3 %).
English: common: rash; uncommon: erythemia multiformea,b, toxic skin eruptionsa,b, drug rash with eosinophilia and systemic symptoms (DRESS) syndrome a,b angioedemaa, urticaria, alopecia, pruritus; rare: Stevens-Johnson syndrome a,b
Maltese: komuni: raxx; mhux komuni: eritema multiformea,b, eruzzjonijiet tossiċi tal-ġildaa,b, sindromu ta' raxx dovut għall-mediċina b'esinofilja u sintomi sistemiċi (DRESS - drug rash with eosinophilia and systemic symptoms)a,b, anġjoedemaa,
English: Ethinyloestradiol AUC ↑48% Ethinyloestradiol cmax ↑15% (↓1% Ethinyloestradiol cmin ↑91%
Maltese: AUC ta' Ethinyloestradiol ↑48 % cmax ta' Ethinyloestradiol ↑15 % (↓1 % cmin ta' Ethinyloestradiol ↑91 %
English: The mechanism of interaction between atazanavir/ritonavir and sofosbuvir/velpatasvir/voxilaprevir is inhibition of OATP1B, Pgp, and CYP3A.
Maltese: Il-mekkaniżmu ta' interazzjoni bejn atazanavir/ritonavir u sofosbuvir/velpatasvir/voxilaprevir huwa l-inibizzjoni ta' OATP1B, Pgp, u CYP3A.
English: The fluticasone propionate plasma levels increased significantly, whereas the intrinsic cortisol levels decreased by approximately 86% (90% confidence interval 82%89%).
Maltese: filwaqt li l-livelli intrinsiċi tal-cortisol naqsu b'madwar 86 % (90 % intervall ta' fiduċja 82%89 %).
English: N88DS, L90M; PI minor: L10CFIRV, V11I, E35G, K43T, Q58E, A71ILTV, G73ACST, T74P, N83D, L89V.
Maltese: L10CFIRV, V11I, E35G, K43T, Q58E, A71ILTV, G73ACST, T74P, N83D, L89V.
English: Atazanavir Krka is an antiviral (or antiretroviral) medicine.
Maltese: Krka huwa mediċina antivirali (jew antiretrovirali).
English: - grazoprevir-containing products, including elbasvir/grazoprevir fixed dose combination and glecaprevir/pibrentasvir fixed dose combination (used to treat chronic hepatitis C infection)
Maltese: - prodotti li fihom grazoprevir, inkluż doża fissa kombinata ta' elbasvir/grazoprevir, u doża fissa kombinata ta' glecaprevir/pibrentasvir (li jintużaw biex jikura infezzjoni tal epatite C kronika)
English: The geometric mean (CV%) for atazanavir cmin and AUC was 654 (76%) ng/ml and 44185 (51%) ng•h/ml, respectively.
Maltese: Il-medja ġeometrika (CV %) għal atazanavir cmin u AUC kienet 654 (76 %) ng/ml u 44,185 (51 %) ng•h/ml, rispettivament.
English: 60 hard capsules
Maltese: Kapsula iebsa 60 kapsula iebsa
English: 30 hard capsules: EU/1/19/1353/003 90 (3 x 30) hard capsules: EU/1/19/1353/004
Maltese: EU/1/19/1353/003 90 (3 x 30) kapsula iebsa:
English: Norgestimate AUC ↑85% (↑67% Norgestimate cmax ↑68% (↑51% Norgestimate cmin ↑102% (↑77%
Maltese: AUC ta' Norgestimate ↑85 % (↑67 % cmax ta' Norgestimate ↑68 % (↑51 % cmin ta' Norgestimate ↑102 % (↑77 %
English: Diltiazem AUC ↑125% (↑109% Diltiazem cmax ↑98% (↑78% Diltiazem cmin ↑142% (↑114%
Maltese: AUC ta' Diltiazem ↑125 % (↑109 % cmax ta' Diltiazem ↑98 % (↑78 % cmin ta' Diltiazem ↑142 % (↑114 %
English: Sildenafil, tadalafil and vardenafil are metabolised by CYP3A4.
Maltese: Sildenafil, tadalafil, vardenafil Sildenafil, tadalafil u vardenafil huma metabolizzati minn CYP3A4.
English: b Ten patients had baseline phenotypic resistance to atazanavir + ritonavir (fold change [FC]>5.2).
Maltese: b Għaxar pazjenti kellhom reżistenza fenotipika tal-linja bażi għal atazanavir + ritonavir (bidla fit-tiwja [FC]>5.2).
English: Ethinyloestradiol AUC ↓19% Ethinyloestradiol cmax ↓16% Ethinyloestradiol cmin ↓37%
Maltese: AUC ta' Ethinyloestradiol↓19 % cmax ta' Ethinyloestradiol ↓16 % cmin ta' Ethinyloestradiol ↓37 %
English: Atazanavir (without ritonavir) has been studied in adult subjects with moderate-to-severe hepatic impairment (14 Child-Pugh Class B and 2 Child-Pugh Class C subjects) after a single 400 mg dose.
Maltese: Atazanavir (mingħajr ritonavir) ġie studjat fuq individwi adulti b'indeboliment epatiku ta' natura moderata sa severa (14-il individwu b'Child-Pugh tal-Klassi B u żewġ individwi b'Child-Pugh tal-Klassi C) wara doża unika ta' 400 mg.
English: Total rifabutin and 25-O-desacetylrifabutin AUC ↑119% (↑78%
Maltese: rifabutin u AUC ta' 25-O-desacetyl rifabutin ↑119 % (↑78 % ↑169 %).
English: Raltegravir AUC ↑41% Raltegravir cmax ↑24% Raltegravir c12hr ↑77% The mechanism is UGT1A1 inhibition.
Maltese: AUC ta' Raltegravir ↑41 % cmax ta' Raltegravir ↑24 % c12hr ta' Raltegravir ↑77 %
English: Didanosine (buffered tablets) 200 mg/stavudine 40 mg, both single dose (atazanavir 400 mg single dose)
Maltese: Didanosine (pilloli buffered) 200 mg/stavudine 40 mg, it tnejn doża waħda