FrancophonIA/ELRC3.0 huggingface dataset:
English: • If you are taking topical formulations of ketoconazole (such as creams, ointments and shampoos), you can continue your treatment, as the amount of ketoconazole absorbed throughout the body is very low with these formulations.
Maltese: • Jekk qed tieħu formulazzjonijiet topiċi ta' ketoconazole (bħal kremi, ingwenti u shampoos) tista' tkompli l-kura tiegħek, peress li l-ammont ta' ketoconazole assorbit mill-ġisem huwa wieħed baxx ħafna b'dawn il-formulazzjonijiet.
English: • Topical ketoconazole formulations have very low systemic absorption and may continue to be used as currently approved.
Maltese: • Il-formulazzjonijiet ta' ketoconazole topikali għandhom assorbiment sistemiku baxx ħafna u jistgħu jibqgħu jintużaw kif approvat attwalment.
English: • Although the potential for hepatotoxicity is a class effect with azole antifungals, the data assessed show that the incidence and seriousness of hepatotoxicity is higher with ketoconazole than with other antifungal agents.1 Reported cases of hepatotoxicity included hepatitis, cirrhosis and liver failure with fatal outcomes or requiring liver transplantation.
Maltese: • Minkejja li l-potenzjal għal epatotossiċità huwa effett tal-klassi bl-antifungali azole, id-dejta vvalutata wriet li l-inċidenza u l-gravità ta' epatotissiċità hija ogħla b'ketoconazole milli b'aġenti antifungali oħrajn.1
English: The Agency's recommendations are based on a review by the Committee for Medicinal Products for Human Use (CHMP), which looked at available data on the benefits of oral ketoconazole and the risk of hepatotoxicity from pre-clinical and clinical studies, post-marketing spontaneous case reports, epidemiological studies and the scientific literature.
Maltese: Ir-rakkomandazzjonijiet tal-Aġenzija huma bbażati fuq reviżjoni mill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP), li ta ħarsa lejn id-dejta disponibbli dwar il-benefiċċji ta' ketoconazole u r-riskju ta' epatotossiċità minn studji prekliniċi u kliniċi, rapporti spontanji ta' każijiet wara t-tqegħid fis-suq, studji epidemoloġiċi u d-dokumentazzjoni xjentifika.
English: The European Medicines Agency is aware that ketoconazole is used off-label for treating patients with Cushing's syndrome.
Maltese: L-Aġenzija Ewropea għall-Mediċini hija konxja li ketoconazole jintuża ‘off-label' fil-kura ta' pazjenti bissindromu ta' Cushing.
English: The French medicine agency, the National Agency for the Safety of Medicine and Health Products (ANSM), concluded that the benefit-risk balance of oral ketoconazole was negative because of a high level of liver injury associated with the medicine and in view of the currently available alternative treatments, which are deemed to be safer.
Maltese: Laġenzija tal-mediċini Franċiża, l-Aġenzija Nazzjonali għas-Sigurtà tal-Mediċini u l-Prodotti tas-Saħħa (ANSM), ikkonkludiet li l-bilanċ bejn il-benefiċċju u r-riskju ta' ketoconazole orali kien negattiv minħabba l-livell għoli ta' ħsara fil-fwied assoċjat mal-mediċina u fid-dawl tal-kuri alternattivi disponibbli attwalment, li huma meqjusa bħala aktar siguri.
English: Taking into account the increased rate of liver injury and the availability of alternative antifungal treatments, the CHMP concluded that the benefits did not outweigh the risks.
Maltese: B'kont meħud taż-żieda fir-rata ta' ħsara fil-fwied u d-disponibbiltà ta' kuri antifungali alternattivi, isCHMP ikkonkluda li l-benefiċċji ma kinux akbar mir-riskji.
English: • Oral (by mouth) ketoconazole has been suspended following a review of data showing higher liver toxicity with this medicine compared with other antifungal medicines.
Maltese: • Ketoconazole orali (li jittieħed mill-ħalq) ġie sospiż wara reviżjoni tad-dejta li turi livell ogħla ta' tossiċità fil-fwied b'din il-mediċina meta mqabbel ma' mediċini antifungali oħra.
English: Topical formulations of ketoconazole (such as creams, ointments and shampoos) can continue to be used as the amount of ketoconazole absorbed throughout the body is very low with these formulations.
Maltese: Il-formulazzjonijiet topiċi ta' ketoconazole (bħal kremi, ingwenti u shampoos) jistgħu jibqgħu jintużaw peress li l-ammont ta' ketoconazole assorbit mill-ġisem huwa wieħed baxx ħafna b'dawn il-formulazzjonijiet.
English: Suspension of marketing authorisations for oral ketoconazole
Maltese: Aktar dwar il-mediċina
English: • The efficacy studies on oral ketoconazole are limited and have not been carried out in line with the most recently agreed guidelines2.
Maltese: • L-istudji dwar l-effikaċja ta' ketoconazole orali huma limitati u ma twettqux f'konformità mal-linji gwida maqbula l-aktar reċentement2.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision valid throughout the EU.
Maltese: L-opinjoni tas-CHMP intbagħtet lill-Kummissjoni Ewropea, li ħarġet deċiżjoni finali li torbot legalment u valida madwar l-UE kollha.
English: Having assessed the available data on the risks with oral ketoconazole, the CHMP concluded that, although liver injury such as hepatitis is a known side effect of antifungal medicines, the incidence and the seriousness of liver injury with oral ketoconazole were higher than with other antifungals.
Maltese: Wara li vvaluta d-dejta disponibbli dwar ir-riskji b'ketoconazole orali, is-CHMP ikkonkluda li, minkejja li l-ħsara fil-fwied bħal epatite huwa effett sekondarju magħruf tal-mediċini antifungali, l-inċidenza u lgravità tal-ħsara fil-fwied b'ketoconazole orali kienu ogħla milli b'antifungali oħrajn.
English: On 25 July 2013, the European Medicines Agency's Committee on Medicinal Products for Human Use (CHMP) recommended that the marketing authorisations of oral ketoconazole-containing medicines should be suspended throughout the European Union (EU).
Maltese: Fil-25 ta' Lulju 2013, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija Ewropea għall-Mediċini, irrakkomanda li l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-mediċini li fihom ketoconazole orali għandhom jiġu sospiżi madwar l-Unjoni Ewropea (UE) kollha.
English: The Committee also concluded that the clinical benefit of oral ketoconazole is uncertain as data on its effectiveness are limited and do not meet current standards, and alternative treatments are available.
Maltese: Il-Kumitat ikkonkluda wkoll li l-benefiċċju kliniku ta' ketoconazole orali mhuwiex wieħed ċert peress li d-dejta dwar l-effikaċja hija limitata u ma tissodisfax l-istandards attwali, u huma disponibbli kuri alternattivi.
English: ** RED80: Rabbit effective dose in 80% of the animals (serology).
Maltese: Doża effettiva għall-fniek fi 80% tal-annimali (seroloġija).
English: * RED60: Rabbit effective dose in 60% of the animals (serology).
Maltese: * RED60:
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 August 2018 EMA/133231/2018
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 ta' Awwissu 2018 EMA/133231/2018
English: More information on Amglidia can be found on the Agency's website: ema.europa.eu/Find medicine.
Maltese: ema.europa.eu/Find medicine.
English: Amglidia is effective in patients with specific genetic mutations (beta-cell ATP-sensitive potassium channel and chromosome 6q24).
Maltese: Amglidia huwa effettiv f'pazjenti b'mutazzjonijiet ġenetiċi speċifiċi (kanal tal-potassju sensittiv għal ATP taċ-ċellola beta u kromożoma 6q24).
English: − strength of Amglidia,
Maltese: − il-qawwa ta' Amglidia,
English: − daily dose of Amglidia in ml,
Maltese: − id-doża ta' kuljum ta' Amglidia f'ml,
English: The active substance in Amglidia, glibenclamide, is a diabetes medicine that belongs to the class of sulfonylureas.
Maltese: Is-sustanza attiva f'Amglidia, il-glibenclamide, hija mediċina tad-dijabete li tappartjeni għall-klassi tassulfonylureas.
English: • Amglidia is an oral suspension available in two strengths: 0.6 mg/ml and 6 mg/ml.
Maltese: • Amglidia huwa sospensjoni orali li tiġi f'żewġ qawwiet: 0.6 mg/ml u 6 mg/ml.
English: Amglidia is available as an oral suspension in two strengths: 0.6 mg/ml and 6 mg/ml, and each strength is available in two presentations: either with a 1-ml oral syringe or with a 5-ml oral syringe.The strength and the size of the oral syringe to be used depends on the dose prescribed.
Maltese: Amglidia jiġi bħala sospensjoni orali f'żewġ qawwiet: 0.6 mg/ml u 6 mg/ml, u kull qawwa tiġi f'żewġ preżentazzjonijiet: jew b'siringa orali ta' 1 ml jew b'siringa orali ta' 5 ml.
English: It works on insulin-producing cells in the pancreas and attaches to special channels on their surface called ATP-sensitive potassium channels (KATP channels), through which potassium ions normally enter the cells and trigger the release of insulin.
Maltese: Din taħdem fuq ċelloli li jipproduċu l-insulina fil-frixa u teħel ma' kanali speċjali fuq ilwiċċ tagħhom li jissejħu kanali tal-potassju sensittivi għal ATP (kanali KATP), li permezz tagħhom iljoni tal-potassju normalment jidħlu fiċ-ċelloli u jiskattaw ir-rilaxx tal-insulina.
English: This is to limit the exposure to the sodium benzoate excipient.
Maltese: Dan sabiex jiġi limitat l-esponiment għall-eċċipjent benżoat tas-sodju.
English: It is a liquid to be given by mouth and is available in two strengths: 0.6 mg/ml and 6 mg/ml.
Maltese: Dan huwa likwidu li jingħata mill-ħalq u jiġi f'żewġ qawwiet: 0.6 mg/ml u 6 mg/ml.
English: • The choice of the oral syringe depends on the volume per dose:
Maltese: • Il-preskrizzjoni għandha tinkludi d-dettalji kollha li ġejjin:
English: The dose is prescribed in millilitre (ml) according to body weight.
Maltese: Id-doża tiġi preskritta f'millilitri (ml) skont il-piż tal-ġisem.
English: It is important that only the syringe provided with the pack is used to measure Amglidia.
Maltese: Huwa importanti li tintuża biss is-siringa pprovduta mal-pakkett biex jitkejjel Amglidia.
English: Once Amglidia is started, it is usually possible to reduce and even stop the dose of insulin the patient is already receiving.
Maltese: Hekk kif jinbeda Amglidia, normalment ikun possibbli li titnaqqas u saħansitra titwaqqaf id-doża tal-insulina li l-pazjent ikun diġà qiegħed jirċievi.
English: • Amglidia 0.6 mg/ml strength should only be used for doses up to 0.6 mg/kg daily.
Maltese: • Il-qawwa ta' Amglidia 0.6 mg/ml għandha tintuża biss għal dożi sa 0.6 mg/kg kuljum.
English: Amglidia 6 mg/ml should be used for doses higher than 0.6 mg/kg daily.
Maltese: Amglidia 6 mg/ml għandu jintuża għal dożi ogħla minn 0.6 mg/kg kuljum.
English: • Amglidia is given twice a day.
Maltese: • Amglidia jingħata darbtejn kuljum.
English: • Parents and carers should use only the oral syringe provided with the package to measure the dose of Amglidia.
Maltese: • Għandha tintuża biss is-siringa orali pprovduta mal-pakkett biex titkejjel id-doża ta' Amglidia.
English: − If the volume per dose is equal to or less than 1 ml, the 1-ml oral syringe should be prescribed;
Maltese: − Jekk il-volum għal kull doża jkun daqs jew inqas minn 1 ml, għandha tiġi preskritta s-siringa orali ta' 1 ml;
English: There are two presentations for each strength: one with an oral syringe of 1 ml and one with an oral syringe of 5 ml (see picture above).
Maltese: Hemm żewġ preżentazzjonijiet għal kull qawwa: waħda b'siringa orali ta' 1 ml u waħda b'siringa orali ta' 5 ml (ara l-istampa ta' hawn fuq).
English: Guide to be given to prescribers to ensure Amglidia is used correctly
Maltese: Aktar informazzjoni dwar Amglidia tinstab fis-sit elettroniku tal-Aġenzija:
English: Healthcare professionals should also explain that the dose is to be given with the oral syringe graduated in ml, provided in the pack.
Maltese: Il-professjonisti tal-kura tas-saħħa għandhom jispjegaw ukoll li d-doża għandha tingħata bis-siringa orali gradwata f'ml, ipprovduta fil-pakkett.
English: (see Section 4.4).
Maltese: (ara Sezzjoni 4.4).
English: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne-Billancourt France
Maltese: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne-Billancourt Franza
English: • fluconazole (antifungal)
Maltese: • fluconazole (antifungali)
English: Nodal Status
Maltese: Status Nodali
English: UNIQUE IDENTIFIER - 2D BARCODE
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D Kartuna :
English: • carbamazepine, phenobarbital, phenytoin (antiepileptics)
Maltese: • carbamazepine, phenobarbital, phenytoin (antiepilettiċi)
English: Carton nerlynx 40 mg
Maltese: nerlynx 40 mg
English: Tablet coating Polyvinyl alcohol Titanium dioxide (E171) Macrogol
Maltese: Kisja tal-pillola Polyvinyl alcohol Titanium dioxide (E171) Macrogol
English: Tablet dimensions are 10.5 mm x 4.3 mm with thickness of 3.1 mm.
Maltese: 5 mm x 4.3 mm bi ħxuna ta' 3.1 mm.
English: Date of first authorisation: 31st August 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 31 ta' Awwissu 2018
English: • erythromycin (antibiotic)
Maltese: • erythromycin (antibijotiku)
English: 26 vs. 55
Maltese: 26 kontra 55
English: 9 vs. 28
Maltese: 9 kontra 28
English: - The active substance is neratinib.
Maltese: - Is-sustanza attiva hi neratinib.
English: There is no data in patients ≥85 years of age.
Maltese: M'hemm l-ebda data f'pazjenti ta' età ta' ≥85 sena.
English: Mannitol (E421) Microcrystalline cellulose Crospovidone Povidone
Maltese: Qalba tal-pillola Mannitol (E421) Microcrystalline cellulose Crospovidone Povidone
English: Severe hepatic impairment (Child-Pugh C).
Maltese: Indeboliment tal-fwied sever (Child-Pugh C).
English: • St John's wort (Hypericum perforatum) (herbal product)
Maltese: • St John's wort (Hypericum perforatum) (prodott erbali) • rifampicin (antimikobatteriku)
English: 19 vs. 35
Maltese: 19 kontra 35
English: 16 vs. 23
Maltese: 16 kontra 23
English: - The other ingredients are: - Tablet core: mannitol (E421), microcrystalline cellulose, crospovidone, povidone, colloidal anhydrous silica, magnesium stearate - Tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, iron oxide red (E172)
Maltese: - Qalba tal-pillola: mannitol (E421), microcrystalline cellulose, crospovidone, povidone, colloidal anhydrous silica, magnesium stearate - Kisja tal-pillola: polyvinyl alcohol, titanium dioxide(E171), macrogol, talc, irox oxide red (E172)
English: 7 vs. 20
Maltese: 7 kontra 20
English: P-glycoprotein transporters
Maltese: Trasportaturi ta' glikoproteina P
English: ULN=Upper Limit Normal; ALT= Alanine Aminotransferase * Per CTCAE v4.0
Maltese: ULN=Limitu ta' Fuq tan-Normal; ALT= Alanina Aminotransferażi
English: 1 vs. 4
Maltese: 1 kontra 4
English: • diltiazem, verapamil (calcium-channel blockers)
Maltese: • diltiazem, verapamil (antagonisti tal-kalċju)
English: Carton 2D barcode carrying the unique identifier included.
Maltese: barcode 2D li jkollu l-identifikatur uniku inkluż.
English: For the full list of excipients, see Section 6.1.
Maltese: Għal-lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1.
English: • Diarrhoea recurs to Grade 2 or higher at 120 mg per day
Maltese: • Id-dijarea tirrikorri għal Grad 2 jew aktar b'120 mg kuljum
English: Carton PC:
Maltese: PC:
English: Placebo) HR (95% CI)
Maltese: HR (95% CI)
English: P-value3
Maltese: Valur p3
English: Severity of diarrhoea*
Maltese: Severità tad-dijarea*
English: Circulating metabolites include neratinib pyridine N-oxide (M3), N-desmethyl neratinib (M6), neratinib dimethylamine N-oxide (M7) and traces of
Maltese: Metaboliti li jiċċirkolaw jinkludu neratinib pyridine N-oxide (M3), N-desmethyl neratinib (M6), neratinib dimethylamine Noxide (M7) u traċċi ta' hydroxyl neratinib N-oxide u neratinib bis-N-oxide (M11).
English: Neratinib metabolites M3, M6, M7 and M11 are negative in the standard battery of in vitro genotoxicity studies.
Maltese: Il-metaboliti ta' neratinib M3, M6, M7 u M11 kienu negattivi fis-sensiela standard ta' studji in vitro dwar il-ġenotossiċità.
English: Very Common Rash2 Common
Maltese: Komuni Ħafna Raxx2
English: • Adjust anti-diarrhoeal treatment
Maltese: • Aġġusta trattament kontra d-dijarea
English: Diarrhoea has been reported during treatment with Nerlynx (see Section 4.2 and Section 4.8).
Maltese: Ġiet irrappurtata dijarea waqt trattament b'Nerlynx (ara Sezzjoni 4.2 u Sezzjoni 4.8).
English: Nerlynx contains the active substance ‘neratinib'.
Maltese: Nerlynx fih is-sustanza attiva “neratinib”.
English: The recommended dose of Nerlynx is 6 tablets once a day (a total of 240 mg).
Maltese: Id-doża rakkomandata ta' Nerlynx hija 6 pilloli darba kuljum (total ta' 240 mg).
English: The frequency of Grade 3 events was similar between Asians and Caucasians (1.6% vs. 1.0%).
Maltese: Il-frekwenza ta' avvenimenti ta' Grad 3 kienet simili bejn l-Asjatiċi u l-Kawkasi (1.6% kontra 1.0%).
English: Alanine aminotransferase increased, and aspartate aminotransferase increased
Maltese: Żieda fl-alanina aminotransferażi, u żieda fl-aspart ataminotransferażi
English: Nerlynx (N=670)
Maltese: (N=670)
English: INFORMATION IN BRAILLE
Maltese: INFORMAZZJONI BIL-BRAILLE Kartuna :
English: Nerlynx dose
Maltese: Nerlynx.
English: Neratinib bound predominantly to HSA and human alpha-1 acid glycoprotein (AAG).
Maltese: Neratinib weħel b'mod predominanti ma' HSA u glikoproteina alpha-1 aċidu (AAG) tal-bniedem.
English: The most common TEAEs in the Skin SOC that occurred more frequently in Asian patients than in Caucasian patients were rash (29.4% vs. 13.5%), Palmar-plantar erythrodysaesthesia syndrome (9.9% vs. 1.0%), and dermatitis acneiform (6.0 vs. 1.0%).
Maltese: ItTEAEs l-aktar komuni fis-SOC Ġilda li seħħew b'mod aktar frekwenti f'pazjenti Asjatiċi milli f'pazjenti Kawkasi kienu raxx (29.4% kontra 13.5%), sindrome tal-palmar-plantar erythrodysaesthesia (9.9% kontra 1.0%), u dermatite akneiforma (6.0 kontra 1.0%).
English: The incidence of Grade 1 and Grade 2 was 6.2% and 1.4% respectively.
Maltese: L-inċidenza ta' Grad 1 u Grad 2 kienet 6.2 % u 1.4 % rispettivament.
English: Placebo (N=1420)
Maltese: (N=1420)
English: 2 Includes rash, rash erythematous, rash follicular, rash generalised, rash pruritic, and rash pustular.
Maltese: 2 Jinkludi raxx, raxx eritematuż, raxx follikulari, raxx ġeneralizzat, raxx pruritiku, u raxx pustulari.
English: Adverse reactions reported as serious included diarrhoea (1.9%), vomiting (1.3%), dehydration (1.1%), nausea (0.5%), alanine aminotransferase increased (0.4%), aspartate aminotransferase increased (0.4%), abdominal pain (0.3%), fatigue (0.3%) and decreased appetite (0.2%).
Maltese: Ir-reazzjonijiet avversi rrappurtati bħala serji kienu jinkludu dijarea (1.9%), rimettar (1.3%), deidrazzjoni (1.1%), nawsja (0.5%), żieda fl-alanina aminotransferażi (0.4%), żieda fl-aspartat aminotransferażi (0.4%), uġigħ addominali (0.3%), għeja (0.3%) u tnaqqis fl-aptit (0.2%).
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, protein kinase inhibitors, ATC code: L01XE45
Maltese: Aġenti antineoplastiċi, aġenti antineoplastiċi oħra, inibituri talproteina kinażi, Kodiċi ATC:
English: • Stop Nerlynx until recovery to ≤ Grade 1
Maltese: • Waqqaf Nerlynx sal-irkupru għal ≤ Grad 1
English: 1 Includes stomatitis, aphthous stomatitis, mouth ulceration, oral mucosal blistering, and mucosal inflammation.
Maltese: 1 Tinkludi stomatite, stomatite aftuża, ulċerazzjoni fil-ħalq, infafet mukożali orali, u infjammazzjoni mukożali.
English: • Grade 3 ALT (>5-20 x ULN)
Maltese: • ALT ta' Grad 3 (>5-20 x ULN)
English: 240 mg daily
Maltese: 240 mg kuljum
English: Neratinib produced inhibitory activity in OCT1 uptake transporter, with an IC50 of 2.9 µM.
Maltese: Neratinib ipproduċa attività inibitorja fi trasportatur tat-teħid OCT1, b'IC50 ta' 2.9 µM.
English: Nerlynx is for oral use.
Maltese: Nerlynx huwa għal użu orali.
English: Neratinib is an irreversible pan-erythroblastic leukaemia viral oncogene homolog (ERBB) tyrosine kinase inhibitor (TKI) that blocks mitogenic growth factor signal transduction through covalent, high affinity binding to the ATP binding site of 3 epidermal growth factor receptors (EGFRs): EGFR (encoded by ERBB1), HER2 (encoded by ERBB2), and HER4 (encoded by ERBB4) or their active heterodimers with HER3 (encoded by ERBB3).
Maltese: Neratinib huwa omologu onkoġenu virali tal-lewkimja paneritroblastiku irriversibbli (ERBB), inibitur tat-tirożina kinażi (TKI) (irreversible pain-ertyhtoblastic leukaemia viral oncogene homolog tyrosine kinase inhibitor) li jimblokka t-transduzzjoni ta' sinjal tal-fattur ta' tkabbir mitoġeniku permezz ta' twaħħil kovalenti ta' affinità għolja mas-sit ta' twaħħil ATP ta' 3 riċetturi tal-fattur ta' tkabbir epidermali (EGFRs): EGFR (ikkodifikat minn ERBB1), HER2 (ikkodifikat minn ERBB2), u HER4
English: 52.3 years (59.9% was ≥50 years old, 12.3% was ≥65 years old); 81.0% were Caucasian, 2.6% black or African American, 13.6% Asian and 2.9% other.
Maltese: L-età medjana fil-popolazzjoni b'intenzjoni ta' trattament (ITT) kienet 52.3 snin (59.9% kellhom ≥50 sena, 12.3 % kellhom ≥65sena); 81.0 % kienu Kawkasi, 2.6 % suwed jew Afrikani Amerikani, 13.6 % Asjatiċi u 2.9 %
English: • Fluid intake of ~2 L should be maintained to avoid dehydration
Maltese: • Għandu jinżamm teħid ta' fluwidu ta' ~2 L sabiex tiġi evitata deidrazzjoni
English: It is currently unknown whether Nerlynx reduces the effectiveness of systemically acting hormonal contraceptives.
Maltese: Bħalissa mhux magħruf jekk Nerlynx inaqqasx l-effikaċja ta' kontraċettivi ormonali li jaħdmu sistemikament.
English: Concomitant treatment with inhibitors of CYP3A4 and P-gp Concomitant treatment with strong CYP3A4 and P-gp inhibitors should be avoided due to risk of increased exposure to neratinib (see Section 4.2 and Section 4.5).
Maltese: Trattament konkomitanti ma' inibituri ta' CYP3A4 u P-gp Kura konkomitanti ma' inibituri qawwija ta' CYP3A4 u P-gp għandha tiġi evitata minħabba riskju għal esponiment miżjud għal neratinib (ara Sezzjoni 4.2 u Sezzjoni 4.5).
English: This pre-systemic interaction of neratinib with digoxin might be clinically relevant for P-gp substrates with a narrow therapeutic window (e.g. dabigatran, digoxin, and fexofenadine).
Maltese: tkun klinikament rilevanti għal substrati ta' P-gp b'medda terapewtika dejqa (eż. dabigatran, digoxin, u fexofenadine).
English: In vitro studies demonstrated that neratinib is a substrate for P-glycoprotein (P-gp).
Maltese: Fi studji in-vitro, neratinib huwa inibitur ta' substrati ta' glikoproteina P (P-gp).
English: • Grade 2 diarrhoea [increase of 4-6 stools per day over baseline] lasting < 5 days
Maltese: • Dijarea ta' Grad 2 [żieda ta' 4-6 ippurgar kuljum aktar mil-linja bażi] li ddum < 5 ijiem
English: Clinical studies with BCRP substrates have not been conducted.
Maltese: Ma twettqux studji kliniċi b'substrati ta' BCRP.
English: In the pivotal phase III study, ExteNET (3004), the frequency of Treatment Emergent Adverse Events (TEAEs) in the Skin and Subcutaneous Disorders System Organ Class (SOC) in Asian patients treated with Nerlynx was higher than in Caucasian patients (56.4% vs. 34.5%) but comparable in placebo patients (24.9% vs. 22.8%).
Maltese: III, ExteNET (3004), il-frekwenza ta' Avvenimenti Avversi li Dehru mittrattament (TEAEs) fis-Sistema tal-Klassifika tal-Organi (SOC) għad-Disturbi fil-Ġilda u fit-Tessuti ta' Taħt il-Ġilda f'pazjenti Asjatiċi ttrattati b'Nerlynx kienet ogħla minn dik f'pazjenti Kawkasi (56.4% kontra 34.5%) iżda komparabbli f'pazjenti fuq plaċebo (24.9% kontra 22.8%).
English: Grade 3 diarrhoea was reported in 37.5% of Nerlynx patients.
Maltese: Dijarea ta' Grad 3 ġiet irrappurtata f'37.5 % tal-pazjenti b' Nerlynx.
English: • Remark on importance of reading the PIL • Remarks on the importance of reporting ADRs
Maltese: • Rimarki dwar l-importanza tar-rappurtar ta' ADRs
English: OR
Maltese: Ara
English: Effect of race
Maltese: Effett tar-razza
English: In patients that were hormone receptor negative, regardless of time from trastuzumab therapy, the hazard ratio for iDFS at 2 years was 0.93, with 95% CI (0.60, 1.43).
Maltese: F'pazjenti li kienu negattivi għar-riċettur tal-ormon, irrispettivament miż-żmien minn terapija bi trastuzumab, il-proporzjon ta' periklu għal iDFS sa sentejn kien 0.93, b'95% CI (0.60, 1.43).
English: Observations with missing data were censored at the last date of assessment.
Maltese: Osservazzjonijiet b'data nieqsa ġew iċċensurati fl-aħħar data ta' valutazzjoni.