FrancophonIA/ELRC3.0 huggingface dataset:
English: A risk management plan has been developed to ensure that Caspofungin Accord is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Caspofungin Accord jintuża bl-aktar mod sigur possibbli.
English: No additional studies in humans were needed as Caspofungin Accord is a generic medicine that is given by infusion and contains the same active substance as Cancidas.
Maltese: Ma kien meħtieġ ebda studju addizzjonali peress li Caspofungin Accord huwa mediċina ġenerika mogħtija permezz ta' infużjoni u fiha l-istess sustanza attiva bħal Cancidas.
English: • suspected fungal infections (such as due to Candida or Aspergillus) when the patient is febrile
Maltese: • suspett ta' infezzjonijiet fungali (bħal dawk dovuti għal Candidajew Aspergillus) meta l-pazjent ikollu d-deni u jkun newtropeniku (ikollu nuqqas ta' ċelloli tad-demm bojod).
English: Why is Caspofungin Accord approved?
Maltese: Għaliex ġie approvat Caspofungin Accord?
English: Because Caspofungin Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Caspofungin Accord huwa mediċina ġenerika, il-benefiċċji u r-riskji tiegħu huma meqjusin listess bħal dawk tal-mediċina ta' referenza.
English: The list of fungi against which Caspofungin Accord is active can be found in the summary of product characteristics (also part of the EPAR).
Maltese: Il-lista ta' fungi li Caspofungin Accord huwa attiv kontrihom tinsab fis-sommarju tal-karatteristiċi tal-prodott (parti wkoll mill-EPAR).
English: Caspofungin Accord is a powder that is made up into a solution for infusion (drip) into a vein.
Maltese: Caspofungin Accord huwa trab li jsir soluzzjoni għall-infużjoni (dripp) fil-vina.
English: Caspofungin Accord should be used with caution in children below 12 months of age, because it has not been studied sufficiently in this age group.
Maltese: Caspofungin Accord għandu jintuża b'kawtela fit-tfal iżgħar minn 12-il xahar, minħabba li għadu ma ġiex studjat b'mod suffiċjenti f'dan il-grupp ta' età.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Caspofungin Accord has been shown to be comparable to Cancidas.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Caspofungin Accord wera li huwa komparabbli ma' Cancidas.
English: In patients between 12 months and 17 years of age, the dose depends on body surface area (calculated using the patient's height and weight).
Maltese: F' pazjenti ta' bejn 12-il xahar u 17-il sena, id-doża tiddependi mill-erja tas-superfiċje tal-ġisem (ikkalkulata mit-tul u l-piż tal-pazjent).
English: What are the benefits and risks of Caspofungin Accord?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Caspofungin Accord?
English: Caspofungin Accord can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of invasive fungal infections.
Maltese: Caspofungin Accord jista' jinkiseb biss b'riċetta ta' tabib u l-kura għandha tinbeda u tkun taħt issuperviżjoni ta' tabib b'esperjenza fl-immaniġġjar tal-infezzjonijiet fungali invażivi.
English: Therefore, the CHMP's view was that, as for Cancidas, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal fil-każ ta' Cancidas, il-benefiċċju huwa akbar mir-riskju identifikat.
English: This means that Caspofungin Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Cancidas.
Maltese: Dan ifisser li Caspofungin Accord huwa simili għall‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem ta' Alimta.
English: Fungal cells treated with Caspofungin Accord have incomplete or defective cell walls, making them fragile, unable to grow and causing their death.
Maltese: Iċ-ċelluli fungali trattati b'Caspofungin Accord għandhom ħitan taċ-ċelluli mhux kompluti jew difettużi, li jagħmilhom fraġli, mhumiex kapaċi jikbru u jikkawża l-mewt tagħhom.
English: Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmith Kline
Maltese: Vaċċin għal influwenza prepandemika (H5N1) (virjon maqsum, mhux attivat, supplimentat) GlaxoSmithKline Biologicals
English: 3.75 µg HA Suspension and Emulsion for emulsion for injection
Maltese: 3.75 µg HA Suspensjoni u emulsjoni għal emulsjoni għallinjezzjoni
English: 2.5 ml (suspension) 2.5 ml (emulsion)
Maltese: 2.5 ml; emulsjoni:
English: Packaging
Maltese: suspensjoni:
English: Intramuscular use suspension (H5N1): vial (glass) emulsion (adjuvant): vial (glass)
Maltese: Użu għal ġolmuskolu emulsjoni: kunjett (ħġieġ); suspensjoni: kunjett (ħġieġ)
English: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/02/news_detail_001446.jsp&mid=WC0b01ac058004d5c1
Maltese: 2 L-Aġenzija Ewropea għall-Mediċini tirrakkomanda kontradikazzjonijiet u twissijiet ġodda għal mediċini li fihom aliskiren, http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/02/news_detail_001446.jsp&mid=WC 0b01ac058004d5c1
English: RAS-acting agents include angiotensinconverting enzyme inhibitors (ACE-inhibitors) such as benazepril, captopril, cilazapril, delapril, enalapril, fosinopril, imidapril, lisinopril, moexipril, perindopril, quinapril, ramipril, spirapril, trandolapril and zofenopril), angiotensin receptor blockers (ARBs) such as candesartan, telmisartan, valsartan, irbesartan, eprosartan, olmesartan, losartan and azilsartan and direct renin inhibitors such as aliskiren.
Maltese: L-aġenti b'azzjoni RAS jinkludu inibituri tal-enzima li tikkonverti angiotensin (inibituri ACE) bħal benazepril, captopril, cilazapril, delapril, enalapril, fosinopril, imidapril, lisinopril, moexipril, perindopril, quinapril, ramipril, spirapril, trandolapril u zofenopril), imblokkaturi tar-riċettur ta' angiotensin (ARBs) bħal candesartan, telmisartan, valsartan, irbesartan, eprosartan, olmesartan, losartan u azilsartan u inibituri diretti ta' renin bħal aliskiren.
English: BMJ.
Maltese: Anness I
English: 1 Makani H, Bangalore S, Desouza KA, Shah A, Messerli FH.
Maltese: 1 Makani H, Bangalore S, Desouza KA, Shah A, Messerli FH. Efficacy and safety of dual blockade of the reninangiotensin system: meta-analysis of randomized trials.
English: The PRAC was also of the opinion that the contraindication based on the ALTITUDE5 study data regarding the concomitant use of ACEinhibitors or ARBs with aliskiren-containing products in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) < 60 ml/min/1.73 m2) was confirmed by the additional data reviewed and that it should also be implemented in the product information of ARBs and ACE-inhibitors.
Maltese: Il-PRAC kien ukoll tal-opinjoni li lkontraindikazzjoni bbażata fuq id-dejta tal-istudju ALTITUDE5 dwar l-użu konkomitanti ta' inibituri-ACE jew ARBs bi prodotti li fihom aliskiren f'pazjenti b'dijabete mellitus jew indeboliment tal-kliewi (rata ta' filtrazzjoni glomerulari (GFR) < 60 ml/min/1.73 m2) kienet ikkonfermata mid-dejta addizzjonali rriveduta u li għandha wkoll tkun implimentata fl-informazzjoni dwar il-prodott tal-ARBs u l-inibituri ACE.
English: The PRAC reviewed the totality of the available data, including clinical trials, meta-analysis and publications, the MAHs' responses as well as the report from the Scientific Advisory Group in Cardiovascular Issues (SAG CVS).
Maltese: Il-PRAC irreveda d-dejta disponibbli kollha, inkluż provi kliniċi, metaanaliżijiet u pubblikazzjonijiet, irrisponsi tal-MAHs kif ukoll ir-rapport mill-Grupp Xjentifiku Konsulattiv fi Kwistjonijiet Kardjovaskulari (CVS tal-SAG).
English: Changes were made to the heart failure indication in section 4.4 for candesartan-containing products and in sections 4.2 and 4.4 for valsartan-containing products, in order to further harmonise the wording for the two substances.
Maltese: Saru bidliet fl-indikazzjoni ta' insuffiċjenza tal-qalb fis-sezzjoni 4.4 għal prodotti li fihom candesartan u fis-sezzjonijiet 4.2 u 4.4 għal prodotti li fihom valsartan, sabiex tiġi armoizzata ulterjorment il-formulazzjoni għaż-żewġ sustanzi.
English: In particular, the publication of a metaanalysis by Makani et al1 involving over 68,000 patients raised concerns that combining several RAS-acting agents may be associated with an increased risk of hyperkalaemia, hypotension and kidney failure, compared with the single use of one RAS-acting agent.
Maltese: B'mod partikolari, il-pubblikazzjoni ta' metaanaliżi minn Makani et al1 li involviet aktar minn 68,000 pazjent qajmet tħassib li l-kombinazzjoni ta' diversi aġenti b'azzjoni RAS tista' tkun assoċjata ma' riskju akbar ta' iperkalemija, ipotensjoni u insuffiċjenza tal-kliewi, meta mqabbel mal-użu waħdieni ta' aġent wieħed b'azzjoni RAS.
English: Having considered the new available evidence from the scientific literature and given the seriousness of the identified safety concerns, the Italian Medicines Agency (AIFA) decided to initiate a review under Article 31 of Council Directive 2001/83/EC on 17 April 2013, referring the matter to the Pharmacovigilance Risk Assessment Committee (PRAC) and requesting the PRAC to issue a recommendation on the benefit-risk of dual RAS blockade therapy through the combined use of ACE-inhibitors, ARBs or aliskiren and whether any regulatory measures should be taken on the marketing authorisations of the products involved in this procedure.
Maltese: Wara li kkunsidrat l-provi l-ġodda disponibbli mid-dokumentazzjoni xjentifika u minħabba s-serjetà talproblemi tas-sigurtà identifikati, l-Aġenzija tal-Mediċini Taljana (AIFA) iddeċidiet li tibda reviżjoni skont l-Artikolu 31 tad-Direttiva tal-Kunsill 2001/83/KE fis-17 ta' April 2013, u rriferiet il-kwistjoni lill-Kumitat tal-Evalwazzjoni tar-Riskju tal-Farmakoviġilanza (PRAC) u talbet lill-PRAC biex joħroġ rakkomandazzjoni dwar il-benefiċċju-riskju ta' terapija tal-imblokk RAS doppja permezz tal-użu kkombinat ta' inibituri ACE, ARBs jew aliskiren u jekk għandhomx jittieħdu xi miżuri regolatorji fuq l-awtorizzazzjonijiet għattqegħid fis-suq tal-prodotti involuti f'din il-proċedura.
English: It was noted that the Committee for Medicinal Products for Human Use (CHMP) had already conducted a review2 under Article 20 of Regulation (EC) No 726/2004 for aliskiren-containing products, concluding that these products should be contraindicated in patients with diabetes mellitus or moderate to severe renal impairment who take ACE-inhibitors or ARBs.
Maltese: Ġie nnotat li l-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) diġà wettaq reviżjoni2 skont lArtikolu 20 tar-Regolament (KE) Nru 726/2004 għal prodotti li fihom aliskiren, li kkonkludiet li dawn ilprodotti għandhom jiġu kontraindikati f'pazjenti b'dijabete mellitus jew b'indeboliment renali moderat sa sever li jieħdu inibituri ACE jew ARBs.
English: RAS-acting agents act by blocking different stages of the renin-angiotensin system, lowering blood pressure and their use in the treatment of hypertension and its complications (including acute myocardial infarction, congestive heart failure and chronic kidney disease) is recommended in many current clinical guidelines.
Maltese: L-aġenti b'azzjoni RAS jaġixxu billi jwaqqfu l-istadji differenti tas-sistema ta' reninangiotensin, it-tnaqqis tal-pressjoni tad-demm u l-użu tagħhom fil-kura ta' ipertensjoni u lkumplikazzjonijiet tagħha (inkluż infart mijokardijaku akut, insuffiċjenza tal-qalb konġestiva u mard talkliewi kroniku) huwa rrakkomandat f'diversi linji gwida kliniċi attwali.
English: In particular the contraindication statements recommended by the PRAC were deleted from sections 5.1 (where proposed) and from section 4.4 for aliskiren, as these were already proposed in section 4.3 and therefore considered redundant.
Maltese: B'mod partikolari, iddikjarazzjonijiet ta' kontraindikazzjoni rrakkomandati mill-PRAC tħassru mis-sezzjonijiet 5.1 (fejn propost) u mis-sezzjoni 4.4 għal aliskiren, peress li dawn kienu proposti fis-sezzjoni 4.3 u għalhekk huma kkunsidrati żejda.
English: The PRAC therefore concluded that dual RAS blockade therapy should not be routinely used in the treatment of heart failure and is not recommended in the general population although it may benefit certain patients who remain symptomatic while receiving monotherapy or who cannot otherwise use alternative therapies, including potentially patients with diabetic nephropathy.
Maltese: Għalhekk, il-PRAC ikkonkluda li t-terapija ta' imblokk RAS doppja ma għandhiex tintuża bħala rutina fil-kura ta' insuffiċjenza tal-qalb u mhijiex irrakkomandata fil-popolazzjoni ġenerali għalkemm jaf tkun ta' benefiċċju għal ċerti pazjenti li jibqgħu sintomatiċi meta jkunu qegħdin jirċievu monoterapija jew li inkella ma jistgħux jużaw terapiji alternattivi, inkluż pazjenti b'potenzjal ta' newroterapija dijabetika.
English: • The PRAC considered that the available efficacy data indicates that dual RAS blockade therapy does not provide significant benefit in the general patient population although certain patient subpopulations may benefit from treatment, provided that it occurs only under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure;
Maltese: • Il-PRAC ikkunsidra li d-dejta disponibbli dwar l-effikaċja tindika li t-terapija ta' imblokk RAS doppja ma tipprovdix benefiċċju sinifikanti fil-popolazzjoni ġenerali tal-pazjenti, għalkemm ċerti sottopopolazzjonijiet ta' pazjenti jafu jibbenefikaw mill-kura, sakemm issir biss taħt superviżjoni ta' speċjalista u soġġett għal sorveljanza mill-qrib frekwenti tal-funzjoni renali, l-elettroliti u l-pressjoni tad-demm;
English: For candesartan- and valsartan-containing products, which are also authorised in the treatment of heart failure, additional information was agreed upon to reflect the fact that dual RAS blockade therapy in combination with an ACE-inhibitor may be of benefit in certain patients who cannot use other heart failure treatments, provided that they are used under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure.
Maltese: Għal prodotti li fihom candesartan u valsartan, li huma wkoll awtorizzati fil-kura ta' insuffiċjenza tal-qalb, intlaħaq ftehim biex jiġi rifless il-fatt li terapija ta' imblokk RAS doppja flimkien ma' inibitur ACE tista' tkun ta' benefiċċju f'ċerti pazjenti li ma jistgħux jużaw kuri għal insuffiċjenza tal-qalb, sakemm jintużaw taħt superviżjoni ta' speċjalista u soġġett għal sorveljanza mill-qrib frekwenti talfunzjoni tal-kliewi, l-elettroliti u l-pressjoni tad-demm.
English: The PRAC was of the opinion that there is considerable evidence from large clinical trials and meta-analyses which conclusively demonstrates that dual RAS blockade therapy through the combined use of ACE-inhibitors, ARBs or aliskiren is associated with an increased risk of adverse events, including hypotension, hyperkalaemia and
Maltese: Il-PRAC kien tal-opinjoni li kien hemm evidenza konsiderevoli minn provi kliniċi u metaanaliżijiet kbar li b'mod konklużiv juru li t-terapija ta' imblokk RAS doppja permezz tal-użu kkombinat ta' inibituri ta' ACE, ARBs jew aliskiren hija assoċjata ma' riskju akbar ta' avvenimenti avversi, inkluż ipotensjoni, iperkalemija u insuffiċjenza tal-kliewi meta mqabbla ma' monoterapija, b'mod partikolari f'pazjenti b'nefropatija dijabetika.
English: The PRAC considered that the available efficacy data indicates that dual RAS blockade therapy does not provide significant benefit in the general patient population, although there is evidence to suggest that some selected patient subpopulations may benefit from this dual RAS blockade therapy.
Maltese: Il-PRAC ikkunsidra li d-dejta disponibbli dwar l-effikaċja tindika li t-terapija ta' imblokk RAS doppja ma tipprovdix benefiċċju sinifikanti fil-popolazzjoni ġenerali tal-pazjenti, għalkemm hemm provi li jissuġġerixxu li xi sottopopolazzjonijiet ta' pazjenti magħżula jistgħu jibbenefikaw minn din it-terapija ta' imblokk RAS doppja.
English: Type AE
Maltese: Tip AE
English: Type C
Maltese: Tip C
English: Lidocaine (systemic) Mexiletine
Maltese: Lidocaine (sistemiku) Mexiletine
English: Oral suspension 200 ml
Maltese: Suspensjoni orali 200 ml
English: PREZISTA/ritonavir 10 kg to < 15 kg N=5
Maltese: PREZISTA/ritonavir 10 kg sa < 15 kg N=5
English: Date of first authorisation: 12 February 2007 Date of latest renewal: 19 September 2013
Maltese: 12 ta' Frar 2007 Data tal-aħħar tiġdid: 19 ta' Settembru 2013
English: Latvija UAB "JOHNSON & JOHNSON" filiāle Latvijā
Maltese: JOHNSON" filiāle Latvijā
English: Ethinylestradiol Norethindrone 35 g/1 mg once daily
Maltese: Ethinylestradiol Norethindrone 35 g/1 darba kuljum
English: Lietuva UAB "JOHNSON & JOHNSON"
Maltese: UAB "JOHNSON &
English: Janssen-Cilag Polska Sp. z o.o.
Maltese: Polska Janssen-Cilag Polska Sp. z o.o.
English: ≥ 30 kg to < 40 kg 675 mg (6.8 ml)
Maltese: ≥ 30 kg sa < 40 kg 675 mg (6.8 ml)
English: Manufacturer Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium
Maltese: Manifattur Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Il-Belġju
English: PREZISTA 100 mg/ml oral suspension darunavir
Maltese: PREZISTA 100 mg/ml suspensjoni orali darunavir
English: 150 mg once every other day rifabutin AUC rifabutin Cmin
Maltese: 150 mg ġurnata iva u oħra le rifabutin AUC rifabutin Cmin
English: België/Belgique/Belgien Janssen-Cilag NV
Maltese: België/Belgique/Belgien Janssen-Cilag NV Tel/Tél:
English: However, unbound darunavir concentrations were approximately 55% (Child-Pugh Class A) and 100% (Child-Pugh Class B) higher, respectively.
Maltese: Madankollu, konċentrazzjonijiet ta' darunavir mhux imwaħħla mal-proteini kienu bejn wieħed u ieħor 55% (Child-Pugh Klassi A) u 100% (Child-Pugh Klassi B) ogħla rispettivament.
English: Contains sodium methyl parahydroxybenzoate (E219).
Maltese: Fih sodium methyl parahydroxybenzoate (E219).
English: sum of active moieties of rifabutin (parent drug + 25-O-desacetyl metabolite)
Maltese: total tan-nofsijiet attivi ta' rifabutin (mediċina oriġinali + il-metabolit 25-O-desacetyl)
English: Poly(vinyl alcohol) - partially hydrolysed Macrogol 3350
Maltese: Rita ta' barra tal-pillola Poly(vinyl alcohol) - parzjalment idrolizzat Macrogol 3350
English: PREZISTA 100 mg/ml oral suspension
Maltese: PREZISTA 100 mg/ml suspensjoni orali
English: PREZISTA oral suspension contains sodium methyl parahydroxybenzoate.
Maltese: PREZISTA suspensjoni orali fih sodium methyl parahydroxybenzoate.
English: 480 tablets in a plastic bottle.
Maltese: 480 pillola fi flixkun tal-plastik.
English: HIV RNA < 50 copies/ml
Maltese: HIV RNA < 50 kopja/ml
English: Imputations according to the TLOVR algorithm Last Observation Carried Forward imputation 95% confidence intervals.
Maltese: Imputazzjonijiet skont l-algoriżmu TLOVR Imputazzjoni ta' Last Observation Carried Forward Intervalli ta' kunfidenza ta' 95%.
English: What PREZISTA contains - The active substance is darunavir.
Maltese: X'fih PREZISTA - Is-sustanza attiva hi darunavir.
English: Excipient with known effect: sodium methyl parahydroxybenzoate (E219) 3.43 mg/ml.
Maltese: Eċċipjent(i) b'effett magħruf: sodium methyl parahydroxybenzoate (E219) 3.43 mg/ml.
English: based on published data with darunavir/ritonavir rosuvastatin AUC ↑ 93% rosuvastatin Cmax ↑ 277% rosuvastatin Cmin ND
Maltese: ibbażat fuq dejta publikata b'darunavir/ritonavir rosuvastatin AUC ↑ 93% rosuvastatin Cmax ↑ 277% rosuvastatin Cmin ND
English: DRESS (Drug Rash with Eosinophilia and Systemic Symptoms) and Stevens-Johnson Syndrome has been rarely (< 0.1%) reported, and during post-marketing experience toxic epidermal necrolysis and acute generalised exanthematous pustulosis have been reported.
Maltese: DRESS (Drug Rash with Eosinophilia and Systemic Symtoms) u s-Sindrome ta' Sevens-Johnson kien irrappurtat b'mod rari (< 0.1%), u waqt l-esperjenza ta' wara t-tqegħid fis-suq ġew irrappurtati nekroliżi epidermali tossika u reazzjoni akuta ta' bżieżaq b'materja mifruxa.
English: EU/1/06/380/007 - 30 film-coated tablets EU/1/06/380/008 - 90 film-coated tablets (3 x 30)
Maltese: EU/1/06/380/007 - 30 pilloli miksijin b'rita EU/1/06/380/008 - 90 pilloli miksijin b'rita (3 x 30)
English: - The other ingredients are hydroxypropylcellulose, microcrystalline cellulose and carmellose sodium, citric acid monohydrate, sucralose, strawberry cream flavour, masking flavour, sodium methyl parahydroxybenzoate (E219), hydrocholoric acid (for pH adjustment), purified water.
Maltese: - Is-sustanzi mhux attivi l-oħra huma hydroxypropylcellulose, microcrystalline cellulose u carmellose sodium, citric acid monohydrate, sucralose, strawberry cream flavour, masking flavour, sodium methyl parahydroxybenzoate (E219), hydrocholoric acid (għal aġġustament talpH), ilma ppurifikat.
English: Tenofovir disoproxil 245 mg once daily tenofovir AUC ↑ 22% tenofovir Cmin ↑ 37% tenofovir Cmax ↑ 24% darunavir AUC ↑ 21% darunavir Cmin ↑ 24% darunavir Cmax ↑ 16% (↑ tenofovir from effect on MDR-1 transport in the renal tubules)
Maltese: Tenofovir disoproxil 245 mg darba kuljum tenofovir AUC ↑ 22% tenofovir Cmin ↑ 37% tenofovir Cmax ↑ 24% darunavir AUC ↑ 21% darunavir Cmin ↑ 24% darunavir Cmax ↑ 16% (↑ tenofovir milleffett fuq it-trasport b'MDR-1 fit-tubi żżgħar tal-kilwa)
English: Lopinavir/ritonavir 533/133.3 mg twice daily lopinavir AUC ↑ 9% lopinavir Cmin ↑ 23% lopinavir Cmax ↓ 2% darunavir AUC ↓ 38% darunavir Cmin ↓ 51% darunavir Cmax ↓ 21% lopinavir AUC ↔ lopinavir Cmin ↑ 13% lopinavir Cmax ↑ 11% darunavir AUC ↓ 41% darunavir Cmin ↓ 55% darunavir Cmax ↓ 21%
Maltese: Lopinavir/ritonavir 533/133.3 mg darbtejn kuljum lopinavir AUC ↑ 9% lopinavir Cmin ↑ 23% lopinavir Cmax ↓ 2% darunavir AUC ↓ 38% darunavir Cmin ↓ 51% darunavir Cmax ↓ 21% lopinavir AUC ↔ lopinavir Cmin ↑ 13% lopinavir Cmax ↑ 11% darunavir AUC ↓ 41% darunavir Cmin ↓ 55% darunavir Cmax ↓ 21%
English: Do not combine PREZISTA with products that contain St John's wort (Hypericum perforatum).
Maltese: Tikkombinax PREZISTA ma' prodotti li fihom St John's wort (Hypericum perforatum).
English: based on published data with darunavir/ritonavir
Maltese: ibbażat fuq dejta publikata b'darunavir/ritonavir
English: Sodium methyl parahydroxybenzoate (E219) Hydrocholoric acid (for pH adjustment) Purified water
Maltese: Sodium methyl parahydroxybenzoate (E219) Hydrocholoric acid (għal aġġustament tal-pH) Ilma ppurifikat
English: Imputations according to the TLOVR algorithm Last Observation Carried Forward imputation
Maltese: Imputazzjonijiet skont l-algoriżmu TLOVR Imputazzjoni ta' Last Observation Carried Forward
English: • antiretroviral therapy (ART)-naïve (see section 4.2).
Maltese: • qatt ma ħadu kura b'antiretrovirali (ART), qabel (ara sezzoni 4.2).
English: * DRV-RAMs: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V and L89V
Maltese: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, u L89V
English: Manufacturer Janssen-Cilag SpA, Via C. Janssen, Borgo San Michele, 04100 Latina, Italy
Maltese: Janssen, Borgo San Michele, 04100 Latina, l-Italja
English: Fluticasone: in a clinical study where ritonavir 100 mg capsules twice daily were co-administered with 50 g intranasal fluticasone propionate (4 times daily) for 7 days in healthy subjects, fluticasone propionate plasma concentrations increased significantly, whereas the intrinsic cortisol levels decreased by approximately 86% (90% CI 82-89%).
Maltese: Fluticasone: fi studju kliniku fejn kapsuli ta' 100 mg ritonavir darbtejn kuljum ingħataw flimkien ma' 50 µg fluticasone propionate mogħti ġol-imnieħer (4 darbiet kuljum) għal 7 ijiem f'pazjenti b'saħħithom, il-konċentrazzjonijiet ta' fluticasone propionate fil-plażma żdiedu b'mod sinifikanti filwaqt li l-livelli intrinsiċi tal-cortisol naqsu b'bejn wieħed u ieħor 86% (90% CI 82 - 89%).
English: Boosted PREZISTA may increase the exposure to grazoprevir.
Maltese: PREZISTA intensifikat jista' jżid lesponiment għal grazoprevir.