FrancophonIA/ELRC3.0 huggingface dataset:
English: The antiviral activity of palivizumab was assessed in a microneutralization assay in which increasing concentrations of antibody were incubated with RSV prior to addition of the human epithelial cells HEp-2.
Maltese: L-attività antivirali ta' palivizumab kienet evalwata fl-assaġġ tal-mikronewtralizzazzjoni, RSV kien inkubat ma' medda ta' żidiet fil-konċentrazzjonijiet tal-antikorp qabel ma kien miżjud maċ-ċelloli epiteljali tal-bniedem HEP -2.
English: Synagis 50 mg powder and solvent for solution for injection
Maltese: Synagis 50 mg trab u solvent għal soluzzjoni għall-injezzjoni
English: The RSV hospitalisation rate observed in patients enrolled with a diagnosis of CLDP was 28/723 (3.9%) and in patients enrolled with a diagnosis of prematurity without CLDP was 34/2583 (1.3%).
Maltese: Ir-rata ta' dħul fl-isptar minħabba RSV kienet osservata f' 28/723 (3.9%) pazjenti li qed jieħdu sehem fl-istudju b'dijanjosi ta' CLDP u 34/2583 (1.3%) pazjenti qed jieħdu sehem fl-istudju b'dijanjosi ta' prematurità mingħajr CLDP.
English: Studies using liquid palivizumab
Maltese: .2 Indikazzjonijiet terapewtiċi
English: Palivizumab binds a highly conserved region on the extracellular domain of mature RSV F protein, referred to as antigenic site II or A antigenic site, which encompasses amino acids 262 to 275.
Maltese: RSV F, imsejjaħ bħala s-sit antiġeniku II jew is-sit antiġeniku A, li jinkludi l-aċidi amminiċi 262 sa 275.
English: It has potent neutralising and fusion-inhibitory activity against both RSV subtype A and B strains.
Maltese: Għandu attivita b'saħħitha biex jinnewtraliżża u jinibixxi fużjoni kontra l-istrains tas-sottotipi A u B tal-RSV.
English: Since the monoclonal antibody is specific for RSV, palivizumab is not expected to interfere with the immune response to vaccines.
Maltese: Peress li l-anti-korp monoklonali hu specifiku għal RSV, palivizumab ma huwiex mistenni li jfixkel ir-rispons ta' immunita' għat-tilqim.
English: A total of 222 children were enrolled in two separate studies to examine the safety of palivizumab when it is administered for a second RSV season.
Maltese: Total ta' 222 tifel/tifla ġew reġistrati f'żewġ studji separati biex tiġi eżaminata s-sigurta' ta' palivizumab meta dan jingħata għat-tieni staġun ta' RSV.
English: Each vial contains 50 mg palivizumab*, providing 100 mg/ml of palivizumab when reconstituted as recommended.
Maltese: Kull kunjett fih 50 mg palivizumab*, li, meta jitħallat kif inhu rrakkommandat, jipproduċi 100 mg/ml ta' palivizumab.
English: Each vial contains 100 mg palivizumab*, providing 100 mg/ml of palivizumab when reconstituted as recommended.
Maltese: Kull kunjett fih 100 mg palivizumab*, li, meta jitħallat kif inhu rrakkommandat, jipproduċi 100 mg/ml ta' palivizumab.
English: • Children born at 35 weeks of gestation or less and less than 6 months of age at the onset of the RSV season.
Maltese: • Tfal li fil-bidu tal-istaġun ta' RSV ikunu twieldu wara 35 gimgħa jew inqas ta' gestazzjoni fittqala jew ikunu ta' eta' ta' inqas minn 6 xhur.
English: Assay interference could lead to false-negative RSV diagnostic test results.
Maltese: Din l-interferenza fit-testijiet tista' twassal għal-riżultati negattivi ħżiena f'testijiet dijanjostiċi tal-RSV.
English: Common adverse reactions occurring with palivizumab are fever, rash, and injection site reaction.
Maltese: Reazzjonijiet avversi komuni li seħħew b'palivizumab kienu deni, raxx u reazzjoni fil-post tal-injezzjoni.
English: Transient, low levels of antipalivizumab antibody were observed in one child after the second dose of palivizumab that dropped to undetectable levels at the fifth and seventh dose.
Maltese: Livelli tranżjenti baxxi ta' anti-korpi ta' palivizumab, ġew osservati f'tifel wieħed wara t-tieni doża ta palivizumab li waqgħet f'livelli li ma' tistax taqrhom fil-ħames u s-seba' doża.
English: - Each 1 ml vial contains 100 mg of palivizumab.
Maltese: - Kull kunjett ta' 1 ml fih 100 mg a' palivizumab.
English: 100 mg of powder in a 10 ml vial (type I glass) with a stopper (butyl rubber) and a flip-off seal (aluminium).
Maltese: 100 mg ta' trab f' kunjett (tal-ħġieġ tat-tip I) li jesa' 10 ml, b'tapp (tal-lastku butyl) u siġill (ta' laluminju) li tiftħu b'daqqa ta' saba`.
English: There was no association observed between the presence of antibody and adverse events.
Maltese: Ma kien hemm l-ebda osservazzjoni li tassoċja il-preżenza tal-antikorp ma avvenimenti avversi.
English: On this basis, the absolute risk reduction is 5.8% which means the number needed to treat is 17 to prevent one hospitalisation.
Maltese: Abbażi ta' dan, it-tnaqqis assolut tar-riskju huwa 5.8% li jfisser li n-numru li wieħed irid jikkura biex jiġi evitat każ ta' sptar wieħed, huwa ta' 17.
English: The volume (expressed in ml) of // Palivizumab // to be administered at one-monthly intervals = [patient weight in kg] multiplied by 0.15.
Maltese: Il-volum (f'ml) ta' Palivizumab li jrid jiġi amministrat f'intervalli ta' xahar = [il-piż tal-pazjent f'kg] immultiplikat b'0.15.
English: Tekturna is a medicine that contains the active substance aliskiren.
Maltese: Tekturna hu mediċina li fiha s-sustanza attiva aliskiren.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tekturna to Novartis Europharm Limited on 22 August 2007.
Maltese: Il-Kummissjoni Ewropea tat l-awtorizzazzjoni għat-tqegħid fis-suq għal Tekturna lil Novartis Europharm Limited fit-22 ta' Awwissu 2007.
English: When the results of the five studies comparing Tekturna taken alone with placebo were looked at together, patients aged under 65 years had an average fall in diastolic blood pressure of 9.0 mmHg after eight weeks of taking 150 mg Tekturna, from an average of 99.4 mmHg at the start of the study.
Maltese: Meta r-riżultati tal-ħames studji li qabblu Tekturna meħud waħdu ma' plaċebo ġew studjati flimkien, il-pazjenti li kellhom inqas minn 65 sena kellhom tnaqqis medju fil-pressjoni dijastolika ta' 9.0 mmHg wara tmien ġimgħat jieħdu 150 mg Tekturna, minn medja ta' 99.4 mmHg filbidu tat-trattament.
English: Combination studies looked at Tekturna used with an angiotensin converting enzyme inhibitor (ramipril), an angiotensin receptor blocker (valsartan), a beta-blocker (atenolol), a calcium-channel blocker (amlodipine) and a diuretic (hydrochlorothiazide).
Maltese: L-istudji tat-tqabbil eżaminaw l-effett ta' Tekturna użat flimkien ma' inibitur tal-enzima li jikkonverti l-anġjotensina (ramipril), ma' sustanza li timblokka r-riċettur tal-anġjotensina (valsartan), ma' beta-blocker (atenolol), u ma' sustanza li timblokka l-kanali tal-kalċju (amlodipina) u sustanza djuretika (idroklorotijażide).
English: The active substance in Tekturna, aliskiren, is a renin inhibitor.
Maltese: Is-sustanza attiva f'Tekturna, aliskiren, hi inibitur tar-renina.
English: EMEA/H/C/852
Maltese: EMEA/H/C/852 RAPPORT PUBBLIKU EWROPEW TA' VALUTAZZJONI (EPAR) TEKTURNA Sommarju tal-EPAR għall-pubbliku
English: Tekturna was studied in 14 main studies involving over 10,000 patients with essential hypertension.
Maltese: Tekturna ġie studjat f'14-il studju ewlieni li fihom ħadu sehem iktar minn 10,000 pazjent b'ipertensjoni essenzjali.
English: Tekturna must also not be taken with ciclosporin (a medicine that reduces the activity of the immune system), quinidine (used to correct irregular heartbeat) or verapamil (used to treat heart problems).
Maltese: Tekturna m'għandux jittieħed ma' ciclosporin (mediċinia li tnaqqas l-attività tas-sistema immunitarja), quinidine (użat biex jirregola taħbit tal-qalb li jkun irregolari) jew verapamil (użat fit-trattament ta' problemi tal-qalb).
English: What is Tekturna?
Maltese: X'inhu Tekturna?
English: The most common side effect with Tekturna (seen in between 1 and 10 patients in 100) is diarrhoea.
Maltese: L-iktar effett sekondarju komuni ta' Tekturna (li deher f'bejn pazjent wieħed u 10 minn kull 100) hu dijarrea.
English: What is the risk associated with Tekturna?
Maltese: X'inhu r-riskju assoċjat ma' Tekturna?
English: How does Tekturna work?
Maltese: Għal xiex jintuża Tekturna?
English: The effects of Tekturna were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Tekturna għall-ewwel ġew ittestjati f'mudeli sperimentali qabel ma ġew studjati filbnedmin.
English: Larger falls were seen in patients aged 65 years or over and those taking higher doses of Tekturna.
Maltese: Fil-pazjenti li kellhom 65 sena jew iktar u f'dawk li kienu qed jieħdu dożi ogħla ta' Tekturna kien hemm tnaqqis ikbar fil-pressjoni.
English: Tekturna, taken alone or in combination with other medicines, was also compared with other medicines for hypertension.
Maltese: Tekturna waħdu kien iktar effikaċi mill-plaċebo u kien effikaċi daqs it-trattamenti komparattivi fittnaqqis tal-pressjoni.
English: The full EPAR for Tekturna can be found here.
Maltese: Għaliex ġie approvat Tekturna?
English: The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Tekturna are greater than its risks for the treatment of essential hypertension.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Tekturna fit-trattament tal-ipertensjoni essenzjali huma ikbar mir-riskji tiegħu.
English: The dose of Tekturna may be increased to 300 mg once a day in patients whose blood pressure is not adequately controlled.
Maltese: Id-doża ta' Tekturna tista' tiżdied għal 300 mg darba kuljum fil-pazjenti li l-pressjoni tagħhom ma tkunx tista' tiġi kkontrollata adegwatament.
English: The recommended dose of Tekturna is 150 mg once a day, either taken alone or in combination with other medicines for hypertension.
Maltese: Id-doża rrakkomandatata ta' Tekturna hi 150 mg darba kuljum, jew waħedha jew flimkien ma' mediċini oħra għall-ipertensjoni.
English: Do not use in pregnant animals, which are intended to produce milk for human consumption, within 2 months of expected parturition.
Maltese: Tużax f'annimali waqt it-tqala li huma intenzjoni li jipproduċu l-ħalib għall-konsum tal-bniedem, fi żmien 2 xhur mit-twelid mistenni.
English: Not authorised for use in lactating animals producing milk for human consumption.
Maltese: L-użu mhuiex awtorizzat f'annimali li jiproduċu ħalib għall-konsum tal-bniedem.
English: Each transdermal patch contains 6 mg norelgestromin (NGMN) and 600 micrograms ethinyl estradiol (EE).
Maltese: Kull garża li terħi l- mediċina minn ġol- ġilda fiha 6 mg norelgestromin (NGMN) u 600 mikrogramma ethinyl estradiol (EE).
English: Each transdermal patch releases 203 micrograms of NGMN and 33.9 micrograms of EE per 24 h.
Maltese: Kull garża li terħi l- mediċina minn ġol- ġilda terħi 203 mikrogramma ta' NGMN u 33.9 mikrogramma ta' EE kull 24 siegħa.
English: Packaging
Maltese: Il- Pakkett
English: Strength Pharmaceutical Form Route of Administration
Maltese: Qawwa Għamla Farmaċewtika Mnejn Jingħata
English: Intrinsa testosterone
Maltese: Intrinsa testosteronu
English: The marketing authorisation holder is Warner Chilcott UK Ltd.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq huwa Warner Chilcott UK Ltd.
English: The patch releases 300 micrograms of the active substance testosterone over 24 hours.
Maltese: Ir-roqgħa tirrilaxxa 300 mikrogramma tas-sustanza attiva testosteronu f'24 siegħa.
English: Other information about Intrinsa:
Maltese: Informazzjoni oħra dwar Intrinsa:
English: The two main studies involved 1,095 women with an average age of 49 years who received Intrinsa for up to a year.
Maltese: Fiż-żewġ studji ewlenin ħadu sehem 1,095 mara b'età medja ta' 49 sena li ngħataw Intrinsa għal mhux iktar minn sena.
English: Intrinsa was more effective than placebo.
Maltese: Intrinsa kien iktar effettiv mill-plaċebo.
English: This document is a summary of the European public assessment report (EPAR) for Intrinsa.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Intrinsa.
English: What is the risk associated with Intrinsa?
Maltese: X'inhu r-riskju assoċjat ma' Intrinsa?
English: Why has Intrinsa been approved?
Maltese: Għaliex ġie approvat Intrinsa?
English: The active substance in Intrinsa, testosterone, is a natural sex hormone produced in men and, to a lesser extent, in women.
Maltese: Is-sustanza attiva f'Intrinsa, jiġifieri t-testosteronu, hija ormon sesswali naturali li jiġi prodott mill-irġiel u wkoll, għad illi bi kwantitajiet iżgħar, min-nisa.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Intrinsa on 28 July 2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Intrinsa fit-28 ta' Lulju 2006.
English: Intrinsa is a transdermal patch (a patch that delivers a medicine across the skin).
Maltese: Intrinsa huwa roqgħa transdermali (roqgħa li tagħti mediċina minn ġol-ġilda).
English: Women using Intrinsa should also use oestrogens, but not of the type known as ‘conjugated oestrogens' because the combination of these with Intrinsa is not as effective as the combination of other types of oestrogen with Intrinsa.
Maltese: In-nisa li jkunu qegħdin jużaw Intrinsa għandhom jużaw estroġeni wkoll, iżda mhux tat-tip magħruf bħala ‘estroġeni konġugati' għax il-kombinazzjoni tagħhom ma' Intrinsa mhijiex effettiva daqs ilkombinazzjoni ta' tipi ta' estroġeni oħrajn ma' Intrinsa.
English: Intrinsa releases testosterone through the skin into the bloodstream to produce testosterone levels that match the levels seen before removal of the womb and ovaries.
Maltese: Intrinsa jirrilaxxa t-testosteronu minn ġol-ġilda għal ġod-demm u jipproduċi livelli ta' testosteronu illi jkunu daqs il-livelli li kien hemm qabel it-tneħħija tal-utru u tal-ovajri.
English: Because testosterone is a male sex hormone, women who are taking Intrinsa should be monitored to see if they develop any ‘androgenic' side effects (development of male characteristics) such as hair growth on the face, deepening of the voice or hair loss.
Maltese: Billi t-testosteronu huwa ormon sesswali maskili, in-nisa li jkunu qed jieħdu Intrinsa għandhom jiġu sorveljati biex ikun magħruf jekk jiżviluppawx effetti sekondarji ‘androġeniċi' (l-iżvilupp ta' karatteristiċi maskili) bħal xagħar fil-wiċċ, tħaxxin tal-leħen jew telf ta' xagħar.
English: The most common side effects with Intrinsa (seen in more than 1 patient in 10) are hirsutism (increased hair growth, especially on the chin and upper lip) and reactions at the site of application of the patch (redness and itching).
Maltese: L-iktar effetti sekondarji komuni ta' Intrinsa (li dehru f'iktar minn pazjent 1 minn kull 10) huma żieda fix-xagħar (speċjalment fuq il-geddum u fix-xoffa ta' fuq) u reazzjonijiet fil-post li fuqu titqiegħed irroqgħa (ħmura u ħakk).
English: Intrinsa was compared with placebo (a patch containing no active substance).
Maltese: Intrinsa tqabbel ma' plaċebo (roqgħa li ma jkun fiha l-ebda sustanza attiva).
English: The company that makes Intrinsa will monitor some of the side effects of Intrinsa closely, such as its androgenic side effects.
Maltese: Il-kumpanija li tagħmel Intrinsa se tissorvelja mill-qrib uħud mill-effetti sekondarji ta' Intrinsa, bħalleffetti sekondarji androġeniċi tiegħu.
English: The CHMP decided that Intrinsa's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Intrinsa huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: How has Intrinsa been studied?
Maltese: Kif ġie studjat Intrinsa?
English: The company will review all of the ongoing studies with Intrinsa to look at potential long-term risks including breast cancer, endometrial cancer (cancer of the lining of the womb) and side effects affecting the heart and blood vessels.
Maltese: Il-kumpanija se tirrevedi l-istudji li għaddejjin bħalissa b'Intrinsa biex tosserva r-riskji possibbli fit-tul fosthom il-kanċer tas-sider, il-kanċer endometrijali (kanċer fil-kisi tal-utru) u l-effetti sekondarji li jaffettwaw il-qalb u l-arterji u l-vini.
English: When the results of the two studies were looked at together, the women who used Intrinsa had an average of 1.07 more satisfying sexual episodes than the women who used placebo over a four-week period.
Maltese: Meta r-riżultati taż-żewġ studji ġew analizzati flimkien, in-nisa li użaw Intrinsa kellhom medja ta' 1.07 episodji sesswali sodisfaċenti iktar min-nisa li ngħataw il-plaċebo matul perjodu ta' erba' ġimgħat.
English: Low testosterone levels have been linked to low sexual desire and to reduced sexual thoughts and arousal.
Maltese: Diversi studji wrew li livelli baxxi ta' testosteronu għandhom rabta ma' xewqa sesswali baxxa u ma' tnaqqis fil-ħsibijiet u fl-eċitament sesswali.
English: Post-hoc analysis.
Maltese: Analiżi post-hoc.
English: Study 19 (D0810C00019)
Maltese: Studju 19 (D0810C00019)
English: Chemotherapy n=97
Maltese: Kimoterapija n=97
English: ECOG performance status (%)
Maltese: Status tal-prestazzjoni ECOG (%)
English: Do not take Lynparza:
Maltese: Tiħux Lynparza:
English: • Capsule content: lauroyl macrogol-32 glycerides.
Maltese: • Kontenut tal-kapsula: lauroyl macrogol-32 glycerides.
English: Macrogol 400
Maltese: Hypromellose Macrogol 400
English: - - - - - - - - - Placebo bd --------------Olaparib 300 mg bd
Maltese: - - - - - - - - - Plaċebo bd --------------Olaparib 300 mg bd
English: HR= Hazard Ratio.
Maltese: HR= Proporzjon ta' Periklu.
English: • Tablet core: copovidone, silica colloidal anhydrous, mannitol, sodium stearyl fumarate.
Maltese: • Qalba tal-pillola: copovidone, silica colloidal anhydrous, mannitol, sodium stearyl fumarate.
English: Capsule content Lauroyl macrogol-32 glycerides
Maltese: Kontenut tal-kapsula Lauroyl macrogol-32 glycerides
English: PFS (63% maturity)
Maltese: PFS (maturità ta' 63%)
English: Uncommon Hypersensitivity a, Dermatitis
Maltese: Mhux komuni Sensittività eċċessiva a, Dermatite
English: AstraZeneca UK Limited Silk Road Business Park Macclesfield, Cheshire, SK10 2NA United Kingdom
Maltese: AstraZeneca UK Limited Silk Road Business Park Macclesfield, Cheshire, SK10 2NA Ir-Renju Unit
English: Pack sizes:
Maltese: Pakketti tad-daqsijiet:
English: Figure 7 PFS (BICR), Forest plot, by prespecified subgroup
Maltese: Figura 7 PFS (BICR), Plot Forest, skont sottogrupp speċifikat minn qabel
English: --------------Placebo bd - - - - - - - - - Olaparib 400 mg bd
Maltese: --------------Plaċebo bd - - - - - - - - - Olaparib 400 mg bd
English: AUC by 170% (90% CI: 144-197%).
Maltese: 33-52%) u l-AUC medja b'170 % (90% CI: 144-197%).
English: The metabolism of olaparib is extensive.
Maltese: Il-metaboliżmu ta' olaparib huwa estensiv.
English: • protease inhibitors boosted with ritonavir or cobicistat, boceprevir, telaprevir, nevirapine,
Maltese: • inibituri tal-protease intensifikati b'ritonavir jew cobicistat, boceprevir, telaprevir, nevirapine,
English: • rifampicin, rifapentine, rifabutin - used for bacterial infections, including tuberculosis (TB)
Maltese: • rifampicin, rifapentine, rifabutin - użati għal infezzjonijiet batteriċi, inkluż tuberkolożi (TB)
English: Chemotherapy (N = 97) Olaparib 300 mg twice daily (N = 205)
Maltese: Kemoterapija (N = 97) Olaparib 300 mg darbtejn kuljum (N = 205)
English: Seven male patients were randomised (5 olaparib and 2 comparator).
Maltese: Ġew randomised seba' pazjenti rġiel (5 olaparib u 2 komparatur).
English: New metastatic breast cancer (%) Hormone receptor status (%) HR+
Maltese: Status tar-riċettur tal-ormon (%) HR+
English: Olaparib 400 mg bd 49/74 (66) Placebo
Maltese: Olaparib 400 mg bd 49/74 (66) Plaċebo
English: Table 1 Tabulated list of adverse reactions
Maltese: Tabella 1 Lista tabulata ta' reazzjonijiet avversi
English: months 0 6 12 18 24 30 36 42 48 54 60 66 72 78 84 90 96 nolaparib nplacebo
Maltese: xhur 0 6 12 18 24 30 36 42 48 54 60 66
English: Based on stratified log-rank test.
Maltese: Ibbażat fuq test log-rank stratifikat
English: A value <1 favours olaparib.
Maltese: Valur <1 jiffavorixxi olaparib.
English: The incidence of MDS/AML cases was similar among gBRCA1m and gBRCA2m patients (1.7% and 1.4%, respectively).
Maltese: L-inċidenza ta' każijiet MDS/AML kienet simili fost pazjenti gBRCA1m u gBRCA2m (1.7% u 1.4%, rispettivament).
English: There are limited clinical data in patients aged 75 years and over.
Maltese: Hemm data klinika limitata f'pazjenti li għandhom 75 sena u aktar.
English: TNBC gBRCA mutation type (%) gBRCA1 gBRCA2 gBRCA1 and gBRCA2 ≥2 Metastatic sites (%) Location of the metastasis (%) Bone only
Maltese: Tip ta' mutazzjoni gBRCA (%) gBRCA1 gBRCA2 gBRCA1 u gBRCA2 ≥2 Siti metastatiċi (%) Post tal-metastasi (%) Għadam biss
English: Common Stomatitis
Maltese: Komuni Stomatite
English: Detection of BRCA mutation
Maltese: Detezzjoni ta' mutazzjoni ta' BRCA
English: * (2-sided)
Maltese: * (miżżewġ naħat)
English: Important differences in posology between Lynparza capsules and tablets
Maltese: Differenzi importanti fil-pożoloġija bejn Lynparza kapsuli u pilloli
English: Table 7 Patient demographic and baseline characteristics in OlympiAD
Maltese: Tabella 7 Karatteristiċi demografiċi u tal-linja bażi tal-pazjent f'OlympiAD
English: Capsule shell Hypromellose Titanium dioxide (E171) Gellan gum (E418) Potassium acetate
Maltese: Qoxra tal-kapsula Hypromellose Titanium dioxide (E171) Gomma ġellan (E418) Potassium acetate
English: • itraconazole, fluconazole - used for fungal infections
Maltese: • itraconazole, fluconazole - użati għal infezzjonijiet fungali
English: Locally advanced
Maltese: Lokalment avvanzata
English: Previous anthracycline and taxane treatment
Maltese: Trattament preċedenti b'anthracycline u taxane
English: EU/1/14/959/002 EU/1/14/959/003 EU/1/14/959/004 EU/1/14/959/005
Maltese: EU/1/14/959/002 EU/1/14/959/003 EU/1/14/959/004
English: efavirenz - used for viral infections, including HIV
Maltese: efavirnez - użati għal infezzjonijiet virali, inkluż l-HIV
English: Age - year (median)
Maltese: Età - sena (medjana)
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista ta' eċċipjenti, ara sezzjoni 6.1.
English: Hard capsule 112 capsules
Maltese: Kapsula iebsa 112-il kapsula.
English: PFS - DCO 30 June 2010
Maltese: PFS - DCO 30 ta' Ġunju 2010
English: The active substance is olaparib.
Maltese: Is-susstanza attiva hi olaparib.
English: Component of a multipack, not to be sold separately.
Maltese: Komponent ta' pakkett multiplu, m'għandux jinbiegħ separatament.
English: • telithromycin, clarithromycin, erythromycin - used for bacterial infections
Maltese: • telithromycin, clarithromycin, erythromycin - użati għal infezzjonijiet batteriċi
English: • Printing ink: shellac, iron oxide black (E172).
Maltese: • Linka tal-Istampar tal-kapsula: shellac, iron oxide black (E172).
English: It cannot be excluded that olaparib may increase the exposure to substrates of BCRP (e.g. methotrexate, rosuvastatin), OATP1B1 (e.g. bosentan, glibenclamide, repaglinide, statins and valsartan), OCT1 (e.g. metformin), OCT2 (e.g. serum creatinine), OAT3 (e.g. furosemide and methotrexate), MATE1 (e.g. metformin) and MATE2K (e.g. metformin).
Maltese: Ma jistax jiġi eskluż li olaparib jista' jżid l-espożizzjoni għas-sottostrati BCRP (eż. methotrexate, rosuvastatin), OATP1B1 (eż. bosentan, glibenclamide, repaglinide, statins u valsartan), OCT1 (eż. metformin), OCT2 (eż. serum creatinine), OAT3 (eż. furosemide u methotrexate), MATE1 (eż. metformin) u MATE2K (eż. metformin).
English: gBRCA1/2-mutated HER2-negative metastatic breast cancer OlympiAD (Study D0819C00003)
Maltese: Kanċer tas-sider metastiku negattiv għall-HER2 mutat gBRCA1/2 OlympiAD (Studju D0819C00003)
English: • Tablet coating: hypromellose, macrogol 400, titanium dioxide (E171), iron oxide yellow
Maltese: • Kisja tal-pillola: hypromellose, macrogol 400, titanium dioxide (E171), iron oxide isfar (E172),
English: PFS (77% maturity) - DCO 09 December 2016
Maltese: PFS (maturità ta' 77%) - DCO 09 ta' Diċembru 2016
English: Olaparib is a type of cancer medicine called a PARP inhibitor (poly [adenosine diphosphate-ribose] polymerase inhibitor).
Maltese: Olaparib huwa tip ta' mediċina kontra l-kanċer imsejħa inibitur PARP (inibitur ta' poly [adenosine diphosphate-ribose] polymerase).