FrancophonIA/ELRC3.0 huggingface dataset:
English: • Grade ≤1;
Maltese: • Grad ≤1;
English: Grading according to CTCAE 4.0.
Maltese: Klassifikazzjoni skont CTCAE 4.0.
English: CTCAE=Common Terminology Criteria for Adverse Events.
Maltese: CTCAE=Common Terminology Criteria for Adverse Events (Kriterji ta' Terminoloġija Komuni għallAvvenimenti
English: Date of first authorisation: 09 November 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 09 Novembru 2016
English: 75 mg/day*
Maltese: 75 mg/jum*
English: • Rifampin used to treat tuberculosis (TB).
Maltese: • Rifampin użat sabiex jittratta t-tuberkulożi (TB).
English: Do not take IBRANCE:
Maltese: Tiħux IBRANCE:
English: A more mature update of efficacy data is reported in Table 8.
Maltese: Aġġornament aktar matur dwar id-data tal-effikaċja huwa rrappurtat f'Tabella 8.
English: Capsule shell: gelatin, red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171).
Maltese: Qoxra tal-kapsula: gelatin, red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171).
English: - use of preparations containing St. John's Wort should be avoided while you are taking IBRANCE.
Maltese: - Użu ta' preparazzjonijiet li fihom St John's Wort għandu jiġi evitat waqt li qed tieħu IBRANCE.
English: (Cyprus Branch) Tηλ+357 22 817690
Maltese: Pfizer Ελλάς Α.Ε. (Cyprus Branch) Tηλ+357 22 817690
English: Tel.: +420-283-004-111
Maltese: s r.o. Tel.: +420-283-004-111
English: Grade 3 ANCb (<1000 to 500/mm3) + Fever ≥38.5 ºC and/or infection
Maltese: ANC ta' Grad 3b (<1000 sa 500/mm + Deni ≥38.5ºC u/jew infezzjoni
English: In vitro, palbociclib is not an inhibitor of CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, and 2D6, and is not an inducer of CYP1A2, 2B6, 2C8, and 3A4 at clinically relevant concentrations.
Maltese: In vitro, palbociclib mhuwiex inibitur ta' CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, u 2D6, u mhuwiex induttur ta' CYP1A2, 2B6, 2C8, u 3A4 f'konċentrazzjonijiet klinikament rilevanti.
English: PAL=palbociclib; LET=letrozole; PCB=placebo.
Maltese: PAL=palbociclib; LET=letrozole; PCB=plaċebo.
English: System Organ Class Frequency Preferred Terma
Maltese: Sistema tal-Klassifika tal-Organi Frekwenza
English: Neutropeniac Leukopeniad Anaemiae Thrombocytopeniaf
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u Manifattur
English: Use of preparations containing St. John's Wort (see section 4.5).
Maltese: John's Wort (ara sezzjoni 4.5).
English: Palbociclib is not a substrate of OATP1B1 or OATP1B3.
Maltese: Palbociclib mhux sustrat ta OATP1B1 jew OATP1B3.
English: In vitro studies with transporters
Maltese: Studji bit-trasportaturi in vitro
English: • Voriconazole, itraconazole, ketoconazole, and posaconazole used to treat fungal infections.
Maltese: • Voriconazole, itraconazole, ketoconazole u posaconazole użati sabiex jittrattaw infezzjonijiet fungali.
English: A total of 405 PFS events were observed; 245 events (55.2%) in the palbociclib plus letrozole arm and 160 (72.1%) in the comparator arm respectively.
Maltese: Total ta' 405 avvenimenti ta' PFS ġew osservati; 245 avveniment (55.2%) fil-parti tal-istudju dwar palbociclib flimkien ma' letrozole u 160 (72.1%) fil-parti tal-istudju dwar il-komparatur rispettivament.
English: The capsule length is 21.7 ± 0.3 mm.
Maltese: It-tul tal-kapsula huwa ta' 21.7 ± 0.3 mm.
English: The capsule length is 19.4 ± 0.3 mm.
Maltese: It-tul tal-kapsula huwa ta' 19.4 ± 0.3 mm.
English: b ANC: Grade 1: ANC < LLN - 1500/mm3; Grade 2: ANC 1000 - <1500/mm3;
Maltese: Grad 1: ANC < LLN - 1500/mm 3; Grad 2: ANC 1000 - <1500/mm 3; Grad 3: ANC 500
English: Frequency categories are defined as: very common (≥1/10), common (≥1/100 to <1/10), and uncommon (≥1/1,000 to
Maltese: Il-kategoriji tal-frekwenzi huma definiti bħala: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), u mhux komuni (≥1/1,000 sa <1/100).
English: *If further dose reduction below 75 mg/day is required, discontinue the treatment.
Maltese: *Jekk ikun meħtieġ aktar tnaqqis tad-doża taħt 75 mg/jum, waqqaf it-trattament.
English: Data from a pharmacokinetic trial in subjects with varying degrees of renal function indicate that total palbociclib exposure (AUCinf) increased by 39%, 42%, and 31% with mild (60 mL/min≤CrCl<90 mL/min), moderate (30 mL/min≤CrCl <60 mL/min), and severe (CrCl <30 mL/min) renal impairment, respectively, relative to subjects with normal (CrCl ≥90 mL/min) renal function.
Maltese: Data minn prova farmakokinetika f'individwi bi gradi li jvarjaw ta' funzjoni tal-kliewi tindika li lesponiment totali għal palbociclib (AUCinf) żdied b'39%, bi 42%, u b'31% b'indeboliment tal-kliewi ħafif (60 mL/min≤CrCl<90 mL/min), moderat (30 mL/min≤CrCl <60 mL/min), u sever (CrCl <30 mL/min), rispettivament, fir-rigward ta' individwi b'funzjoni tal-kliewi normali (CrCl ≥90 mL/min).
English: 125 mg/day
Maltese: 125 mg/jum
English: The capsule length is 18.0 ± 0.3 mm.
Maltese: It-tul tal-kapsula huwa ta' 18.0 ± 0.3 mm.
English: * Adverse Drug Reaction (ADR) identified post-marketing.
Maltese: Reazzjoni Avversa tal-Mediċina (ADR - adverse drug reaction) identifikata wara t-tqegħid fis-suq.
English: • Lopinavir, indinavir, nelfinavir, ritonavir, telaprevir, and saquinavir used to treat HIV
Maltese: • Lopinavir, indinavir, nelfinavir, ritonavir, telaprevir, u saquinavir użati sabiex jittrattaw infezzjoni tal-HIV/AIDS.
English: Across clinical trials (PALOMA-1, PALOMA-2, PALOMA-3), 1.4% of IBRANCE-treated patients had ILD/pneumonitis of any grade, 0.1% had Grade 3, and no Grade 4 or fatal cases were reported.
Maltese: Fil-provi kliniċi (PALOMA-1, PALOMA-2, PALOMA-3), 1.4% tal-pazjenti ttrattati b'IBRANCE kellhom ILD/pulmonite ta' kwalunkwe grad, 0.1% kellhom Grad 3, u ma ġew irrappurtati l-ebda każijiet ta' Grad 4 jew fatali.
English: The relevant Kaplan-Meier plots are shown in Figures 2 and 3, respectively.
Maltese: Id-dijagrammi Kaplan-Meier rilevanti huma murija f'Figuri 2 u 3, rispettivament.
English: 100 mg/day
Maltese: 100 mg/jum
English: Febrile neutropenia has been reported in about 2% of patients exposed to IBRANCE across the overall clinical programme.
Maltese: In-newtropenija bid-deni ġiet irrappurtata f'madwar 2% tal-pazjenti esposti għal IBRANCE filprogramm kliniku ġenerali.
English: Grade 3: ANC 500 - <1000/mm3; Grade 4: ANC <500/mm3.
Maltese: <1000/mm 3; Grad 4: ANC <500/mm
English: IBRANCE plus Letrozole (N = 444)
Maltese: IBRANCE flimkien ma' Letrozole (N = 444)
English: Printing ink: shellac, titanium dioxide (E171), ammonium hydroxide (28% solution), propylene glycol, simeticone (see section 2 “IBRANCE contains lactose”).
Maltese: Inka tal-istampar: shellac, titanium dioxide (E171), ammonium hydroxide, propylene glycol, simeticone (ara sezzjoni 2 “IBRANCE fih lactose”).
English: IBRANCE 100 mg hard capsules EU/1/16/1147/003
Maltese: IBRANCE 100 mg kapsuli ibsin EU/1/16/1147/003
English: MARKETING AUTHORISATION HOLDER Pfizer Europe MA EEIG
Maltese: Pfizer Europe MA EEIG
English: IBRANCE 125 mg hard capsules EU/1/16/1147/005
Maltese: IBRANCE 125 mg kapsuli ibsin EU/1/16/1147/005
English: IBRANCE plus fulvestrant (N=141)
Maltese: IBRANCE flimkien ma' fulvestrant (N=141)
English: FUL=fulvestrant; PAL=palbociclib; PCB=placebo.
Maltese: PAL=palbociclib; PCB=plaċebo.
English: • Clarithromycin and telithromycin antibiotics used to treat bacterial infections.
Maltese: • Antibijotiċi clarithromycin u telithromycin li jintużaw għat-trattament ta' infezzjonijiet batteriċi.
English: Withhold IBRANCE until recovery to Grade ≤2.
Maltese: Waqqaf IBRANCE sal-irkupru għal Grad ≤2.
English: • Enzalutamide to treat prostate cancer.
Maltese: • Enzalutamide għat-trattament ta' kanċer tal-prostata.
English: IBRANCE plus fulvestrant (N=206)
Maltese: IBRANCE flimkien ma' fulvestrant (N=206)
English: With repeated once daily administration, palbociclib accumulates with a median accumulation ratio of 2.4 (range 1.5-4.2).
Maltese: B'għoti ripetut ta' darba kuljum, palbociclib jakkumula bi proporzjon t'akkumulazzjonim medja ta' 2.4 (medda 1.5-4.2).
English: In vitro evaluations indicate that palbociclib has low potential to inhibit the activities of organic anion transporter (OAT)1, OAT3, organic cation transporter (OCT)2, organic anion transporting polypeptide (OATP)1B1, OATP1B3, and bile salt export pump (BSEP) at clinically relevant concentrations.
Maltese: Evalwazzjonijiet in vitro jindikaw li palbociclib għandu potenzjal baxx sabiex jinibixxi l-attivitajiet tat-trasportatur anijonu organiku (OAT)1, OAT3, tat-trasportatur katjoniku organiku (OCT)2, talpolypeptide trasportanti anijoniku organiku (OATP)1B1, OATP1B3, u tal-pompa ta' esportazzjoni talmelħ tal-bila (BSEP) f'konċentrazzjonijiet klinikament rilevanti.
English: These systemic toxicities were generally observed at clinically relevant exposures based on AUC.
Maltese: Dawn l-effetti tossiċi sistemiċi kienu ġeneralment osservati f'esponimenti klinikament rilevanti abbażi tal-AUC.
English: The concomitant use of strong CYP3A inhibitors including, but not limited to: clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, saquinavir, telaprevir, telithromycin, voriconazole, and grapefruit or grapefruit juice, should be avoided (see sections 4.2 and 4.4).
Maltese: L-użu fl-istess ħin ta' inibituri qawwija ta' CYP3A jinkludu, iżda mhumiex limitati għal: clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, saquinavir, telaprevir, telithromycin, voriconazole, u l-grejpfrut jew il-meraq talgrejpfrut, għandu jiġi evitat (ara sezzjoni 4.2 u 4.4).
English: g Stomatitis includes the following PTs: Aphthous stomatitis, Cheilitis, Glossitis, Glossodynia, Mouth ulceration, Mucosal inflammation, Oral pain, Oropharyngeal discomfort, Oropharyngeal pain, Stomatitis.
Maltese: Stomatite aphthous, Cheilitis, Glossite, Glossodinja, Ulċera fil-ħalq, Infjammazzjoni tal-mukoża, Uġigħ orali, Skumdità orofarinġeali, Uġigħ orofarinġeali, Stomatite. .
English: Therefore, IBRANCE should be taken with food, preferably a meal (see sections 4.2 and 5.2).
Maltese: Għaldaqstant, IBRANCE għandu jittieħed mal-ikel, preferibbilment ma' ikla (ara sezzjonijiet 4.2 u 5.2).
English: Drug-drug interaction between palbociclib and oral contraceptives
Maltese: Interazzjoni bejn Palbociclib u kontraċettivi orali
English: Day 15 of first 2 cycles:
Maltese: Jum 15 tal-ewwel 2 ċikli:
English: Strong inhibitors of CYP3A4 may lead to increased toxicity (see section 4.5).
Maltese: Inibituri qawwija ta' CYP3A4 jistgħu jwasslu għal żieda fit-tossiċità (ara sezzjoni 4.5).
English: Concomitant treatment with inhibitors or inducers of CYP3A4
Maltese: Trattament fl-istess ħin b'inibituri jew indutturi ta' CYP3A4
English: The mean absolute bioavailability of palbociclib after an oral 125 mg dose is 46%.
Maltese: Ilbijodisponibbiltà assoluta medja ta' palbociclib wara doża orali ta' 125 mg hija ta' 46%.
English: DDI studies of palbociclib with oral contraceptives have not been conducted (see section 4.6).
Maltese: Ma twettqux studji ta' interazzjoni bejn il-mediċini ta' palbociclib ma' kontraċettivi orali (ara sezzjoni 4.6).
English: IBRANCE is an anticancer medicine containing the active substance palbociclib.
Maltese: IBRANCE huwa mediċina ta' kontra l-kanċer li fiha s-sustanza attiva palbociclib.
English: h Rash includes the following PTs: Rash, Rash maculo-papular, Rash pruritic, Rash erythematous, Rash papular, Dermatitis, Dermatitis acneiform, Toxic skin eruption.
Maltese: Raxx jinkludi l-PTs li ġejjin: Raxx, Raxx makulopapulari, Raxx pruritiku, Raxx papulari, Raxx eritematuż, Raxx papulari, Dermatite, Dermatite acneiform, Eruzzjoni tossika tal-ġilda.
English: The dose of sensitive CYP3A substrates with a narrow therapeutic index (e.g., alfentanil, cyclosporine, dihydroergotamine, ergotamine, everolimus, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus) may need to be reduced when coadministered with IBRANCE as IBRANCE may increase their exposure.
Maltese: Id-doża ta' sottostrati sensittivi ta' CYP3A b'indiċi terapewtiku dejjaq (eż., alfentanil, cyclosporine, dihydroergotamine, ergotamine, everolimus, fentanyl, pimozide, quinidine, sirolimus, u tacrolimus) jista' jkun hemm bżonn li titnaqqas meta tingħata flimkien ma' IBRANCE minħabba li IBRANCE jista' jżid l-esponiment tagħhom.
English: IBRANCE hard capsules come in different strengths.
Maltese: IBRANCE kapsuli ibsin jiġu f'qawwiet differenti.
English: • Cyclosporine, everolimus, tacrolimus, and sirolimus used in organ transplantation to prevent rejection.
Maltese: • Cyclosporine, everolimus, tacrolimus, sirolimus użati fit-trapjanti tal-organi sabiex jipprevjenu r-rifjut.
English: - The other ingredients are: Capsule content: microcrystalline cellulose, lactose monohydrate, sodium starch glycolate type A, colloidal anhydrous silica, magnesium stearate.
Maltese: Kontenut tal-kapsula: microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE33.
Maltese: Sustanzi antineoplastiċi, inibituri ta' protein kinase, Kodiċi ATC:
English: PVC/PCTFE/PVC/Al blister strip containing 7 hard capsules (one capsule per cell).
Maltese: Strixxi bil-folji tal-PVC/PCTFE/PVC/Al li fihom 7 kapsuli iebsin (kapsula waħda għal kull ċellula).
English: Available clinical data are reported in the clinical efficacy and safety section (see section
Maltese: Data klinika disponibbli huma rrappurtati fit-taqsima effikaċja klinika u sigurta (ara sezzjoni 5.1).
English: The safety and efficacy of IBRANCE in children and adolescents <18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' IBRANCE fit-tfal u adolexxenti <18-il sena ma ġewx determinti s'issa.
English: Benefit was also observed regardless of lines of prior therapy in the metastatic setting, whether 0 (HR of 0.59 [95% CI: 0.37, 0.93]), 1 (HR of 0.46 [95% CI: 0.32, 0.64]), 2 (HR of 0.48 [95% CI: 0.30, 0.76]), or ≥3 lines (HR of 0.59 [95% CI: 0.28, 1.22]).
Maltese: Kien osservat ukoll benefiċċju irrispettivament mil-linji ta' terapija minn qabel fl-isfond metastatiku, kemm jekk 0 (HR ta' 0.59 [95% CI: 0.37-0.93]), 1 (HR ta' 0.46 [95% CI: 0.32-0.64]), 2 (HR ta' 0.48 [95% CI: 0.30-0.76]), jew ≥3 linji (HR ta' 0.59 [95% CI: 0.28-1.22]).
English: For the 51 patients IHC negative for Rb expression, the difference between treatment arms was not statistically significant (HR of 0.868 [95% CI: 0.424, 1.777], mPFS 23.2 versus 18.5 months) for the palbociclib plus letrozole arm versus the placebo plus letrozole arm, respectively.
Maltese: Għal 51 pazjent b'IHC negattiv għall-espressjoni Rb, id-differenza bejn ittrattament ma kinitx statistikament sinifikanti (HR ta' 0.868 [95% CI: 0.424, 1.777], mPFS 23.2 kontra 18.5 -il xhar) għal palbociclib flimkien ma' letrozole kontra l-plaċebo plus letrozole, rispettivament.
English: Binding of palbociclib to human plasma proteins in vitro was ~85%, with no concentration dependence.
Maltese: L-irbit ta' palbociclib ma' proteini fil-plażma tal-bniedem in vitro kien ~85%, mingħajr dipendenza ta' konċentrazzjoni.
English: Laboratory abnormalities
Maltese: Anormalitajiet tallaboratorju
English: Red iron oxide (E172)
Maltese: Red iron oxide (E172) Yellow iron oxide (E172) Titanium dioxide (E171)
English: Day 1 of cycle:
Maltese: Jum 1 taċ-ċiklu:
English: The most common (≥2%) Grade ≥3 adverse reactions of palbociclib were neutropenia, leukopenia, infections, anaemia, aspartate aminotransferase (AST) increased, fatigue, and alanine aminotransferase (ALT) increased.
Maltese: L-aktar reazzjonijiet avversi tal-mediċina komuni (≥2%) ta' Grad ≥3 ta' palbociclib kienu n-newtropenija, il-lewkopenija, infezzjonijiet, l-anemija, żieda f'aspartate aminotransferase (AST- aspartate aminotransferase), lgħeja u żieda f'alanine aminotransferase (ALT - alanine aminotransferase).
English: Secondary endpoints included OR, CBR, overall survival (OS), safety, and time-to-deterioration (TTD) in pain endpoint.
Maltese: Il-punti aħħari sekondarji inkludew OR, CBR, sopravivenza globali (OS - overall survival), sigurtà, u l-punt aħħari kompost taż-żmien għad-deterjorazzjoni.
English: Grade 3 n (%)
Maltese: n (%)
English: Kaplan-Meier plot of overall survival (intent-to-treat population) - PALOMA-3 study (13 April 2018 cutoff)
Maltese: Figura 3 Dijagramma Kaplan-Meier ta' sopravivenza globali (popolazzjoni bl-intenzjoni li tiġi ttrattata) - studju PALOMA-3 (13 ta' April 2018 data tal-għeluq tad-data)
English: Data from a pharmacokinetic trial in subjects with varying degrees of hepatic function indicate that palbociclib unbound exposure (unbound AUCinf) decreased by 17% in subjects with mild hepatic impairment (Child-Pugh class A), and increased by 34% and 77% in subjects with moderate (Child-Pugh class B) and severe (Child-Pugh class C) hepatic impairment, respectively, relative to subjects with normal hepatic function.
Maltese: Data minn prova farmakokinetika f'individwi bi gradi li jvarjaw ta' funzjoni tal-fwied tindika li lesponiment mhux marbut ta' palbociclib (AUCinf mhux marbut) naqas bi 17% f'individwi b'indeboliment tal-fwied (Klassi A ta' Child-Pugh), u żdied b'34% u b'77% f'individwi b'indeboliment tal-fwied moderat (Klassi B ta' Child-Pugh) u sever (Klassi Ċ ta' Child-Pugh), rispettivament, fir-rigward ta' individwi b'funzjoni tal-fwied normali.
English: Progression-free survival (PFS) Number of events (%) Median [months (95% CI)] Hazard ratio (95% CI) and p-value
Maltese: Sopravivenza Bla Progressjoni Numru ta' avvenimenti (%) Medja [xhur (95% CI)] Proporzjon ta' periklu (95% CI) u valur-p
English: 4.5 Interaction with other medicinal products and other forms of interaction Palbociclib is primarily metabolised by CYP3A and sulphotransferase (SULT) enzyme SULT2A1.
Maltese: Palbociclib hu primarjament metabolizzat minn CYP3A u l-enzima SULT2A1 ta' sulfotransferase (SULT).
English: OR* [% (95% CI)] OR* measurable disease [% (95% CI)] CBR* [% (95% CI)] N=number of patients; CI=confidence interval; NE=not estimable; OR=objective response; CBR=clinical benefit response; PFS=progression-free survival.
Maltese: OR* [% (95% CI)] OR* marda li titkejjel [% (95% CI)] CBR* [% (95% CI)] N=numru ta' pazjenti; CI=intervall ta' kunfidenza; NE=ma jistax jiġi stmat;
English: Secondary efficacy endpoints included objective response (OR), clinical benefit response (CBR), safety, and change in quality of life (QoL).
Maltese: Punti aħħarin dwar l-effikaċja sekondarja inkludew ir-rispons oġġettiv (OR, objective response), rispons ta' benefiċċju kliniku, sigurtà, u bidla fil-kwalità tal-ħajja (QoL, quality of life).
English: Permanently discontinue IBRANCE in patients with severe interstitial lung disease (ILD)/pneumonitis (see section 4.4).
Maltese: Waqqaf IBRANCE b'mod permanenti f'pazjenti b'marda interstizjali tal-pulmun (ILD - interstitial lung disease)/pulmonite severa (ara sezzjoni 4.4).
English: • Pimozide used to treat schizophrenia and chronic psychosis.
Maltese: • Pimozide użat sabiex jittratta l-iskiżofrenija u l-psikożi kronika.
English: Peak palbociclib exposure (Cmax) was increased by 17%, 12%, and 15% for mild, moderate, and severe renal impairment, respectively, relative to subjects with normal renal function.
Maltese: L-esponiment massimu għal palbociclib (Cmax) żdied bi 17%, bi 12%, u bi 15% għal indeboliment tal-kliewi, ħafif, moderat u sever, rispettivament, fir-rigward ta' individwi b'funzjoni tal-kliewi normali.
English: Based on in vitro data, palbociclib is predicted to inhibit intestinal P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) mediated transport.
Maltese: Abbażi ta' data in vitro, palbociclib huwa mbassar li jinibixxi P-glycoprotein (P-gp) intestinali u ttrasport medjat tal-proteina tar-reżistenza tal-kanċer tas-sider (BCRP, breast cancer resistance protein).
English: • Sulfasalazine used to treat rheumatoid arthritis.
Maltese: • Sulfasalazine użat sabiex jittratta l-artrite rewmatika.
English: Placebo plus Letrozole (N = 222)
Maltese: Plaċebo flimkien ma' Letrozole (N = 222)
English: Patient-reported symptoms were assessed using the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 and its Breast Cancer Module (EORTC QLQ-BR23).
Maltese: Is-sintomi rrappurtati mill-pazjenti kienu evalwati bl-użu tal-kwestjonarju dwar il-kwalità tal-ħajja (QLQ)-C30 tal-Organizzazzjoni Ewropea għar-Riċerka u t-Trattament tal-Kanċer (EORTC, European Organisation for Research and Treatment of Cancer) u l-Modulu tal-Kanċer tas-Sider (EORTC QLQBR23).
English: Other medicines and IBRANCE
Maltese: Mediċini oħra u IBRANCE
English: Updated Analysis (31 May 2017 Cutoff)
Maltese: Analiżi Aġġornata (Data ta' għeluq 31 ta' Mejju 2017)
English: IBRANCE 75 mg, 100 mg, and 125 mg are available in blister packs of 21 or 63 hard capsules and in plastic bottles of 21 hard capsules.
Maltese: IBRANCE 75 mg, 100 mg u 125 mg huma disponibbli bħala folji ta' 21 jew 63 kapsula iebsa u fi fliexken tal-plastik b'21 kapsula iebsa.
English: s r.o.
Maltese: HR = 0.
English: Similarly, a reduction in the risk of disease progression or death in the palbociclib plus letrozole arm was observed in 512 patients whose tumour tested positive for Rb protein expression by immunohistochemistry (IHC) (HR of 0.543 [95% CI: 0.433, 0.681], mPFS 27.4 months versus 13.7 months).
Maltese: Bl-istess mod, ġie osservat tnaqqis fir-riskju ta' progressjoni tal-marda jew mewt fl-istudju dwar palbociclib flimkien ma' letrozole f'512 pazjent li kellhom tumor li ttestja pożittiv għal espressjoni talproteina Rb mill-immunoħistokemistrija (IHC) (HR ta' 0.543 [95% CI: 0.433, 0.681], mPFS 27.4 xhur kontra 13.7 xhur)].
English: Placebo plus fulvestrant (N=105)
Maltese: Plaċebo flimkien ma' fulvestrant (N=105)
English: WBC decreased Neutrophils decreased Anaemia
Maltese: WBC imnaqqsa Newtrofili mnaqqsa Anemija
English: Efficacy results - PALOMA-3 study (investigator assessment, intent-to-treat population)
Maltese: Tabella 8 - Riżultati dwar l-effikaċja - PALOMA-3 (evalwazzjoni tal-investigatur, popolazzjoni bl-intenzjoni li titratta)
English: Drug-drug interaction between palbociclib and fulvestrant
Maltese: Interazzjoni bejn palbociclib u fulvestrant
English: Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported (see section 4.8).
Maltese: Ġew osservati każijiet addizzjonali ta' ILD/pulmonite fil-kuntest ta' wara t-tqegħid fis-suq, b'rapporti ta' mwiet (ara sezzjoni 4.8).
English: ANC=absolute neutrophil counts; CTCAE=Common Terminology Criteria for Adverse Events; LLN=lower limit of normal.
Maltese: Avversi); LLN=lower limit of normal (limitu t'isfel tan-normal)
English: IBRANCE 75 mg hard capsules IBRANCE 100 mg hard capsules IBRANCE 125 mg hard capsules
Maltese: IBRANCE 75 mg kapsuli ibsin IBRANCE 100 mg kapsuli ibsin IBRANCE 125 mg kapsuli ibsin
English: Ammonium hydroxide (28% solution)
Maltese: Titanium dioxide (E171) Ammonium hydroxide (28% soluzzjoni) Propylene glycol
English: Palbociclib was negative for carcinogenicity in transgenic mice at doses up to 60 mg/kg/day (No Observed Effect Level [NOEL] approximately 11 times human clinical exposure based on AUC).
Maltese: Palbociclib kien negattiv għall-karċinoġeniċità fil-ġrieden transġeniċi f'dożi sa 60 mg/kg/jum (Livell tal-Ebda Effett Osservat [No Observed Effect Level, NOEL] bejn wieħed u ieħor 11-il darba l-esponiment kliniku fil-bniedem abbażi tal-AUC).
English: Palbociclib may decrease fertility in men.
Maltese: Palbociclib jista' jnaqqas il-fertilità fl-irġiel.
English: Interstitial lung disease/pneumonitis
Maltese: Marda interstizjali tal-pulmun/pulmonite
English: Placebo plus fulvestrant (N=69)
Maltese: Plaċebo flimkien ma' fulvestrant (N=69)