FrancophonIA/ELRC3.0 huggingface dataset:
English: Thus patients receiving Abraxane should be vigilantly monitored by physicians for the occurrence of cardiac events.
Maltese: Għaldaqstant, il-pazjenti li jkunu qed jingħataw Abraxane, għandhom ikunu mmonitorjati bl-attenzjoni għal xi avvenimenti kardijaċi.
English: This may be followed by storage in the infusion bag for 4 hours below 25°C.
Maltese: Dan jista' jiġi segwit minn ħażna fil-borża tal-infużjoni għal 4 sigħat f'temperaturi taħt 25°C.
English: Rare: Cystoid macular oedema2
Maltese: Edema makulari ċistojde
English: Reconstituted Abraxane suspension is administered intravenously using an infusion set incorporating a 15 µm filter.
Maltese: Agħti s-suspensjoni rikostitwita ta' Abraxane ġol-vina billi tuża sett tal-infużjoni li jinkorpora filtru ta' 15 µm.
English: Each vial contains 100 mg or 250 mg of paclitaxel formulated as albumin bound nanoparticles.
Maltese: Kull kunjett fih 100 mg jew 250 mg ta' paclitaxel ifformulat bħala nanopartikuli mwaħħla malalbumina.
English: This multi-centre trial was conducted in patients with metastatic breast cancer, who were treated every 3 weeks with single-agent paclitaxel, either as solvent-based paclitaxel 175 mg/m2 given as a 3-hour infusion with premedication to prevent hypersensitivity (N = 225), or as Abraxane 260 mg/m2 given as a
Maltese: Din il-prova klinika f'ħafna ċentri saret f'pazjenti b'kanċer metastatiku tas-sider, li kienu kkurati kull 3 ġimgħat b'paclitaxel waħdu, jew bħala paclitaxel ibbażat fuq is-solvent 175 mg/m mogħti bħala infużjoni ta' 3 sigħat bi premedikazzjoni biex tiġi evitata s-sensittività eċċessiva (N = 225), jew bħala Abraxane 260 mg/m mogħti bħala infużjoni ta' 30 minuta mingħajr premedikazzjoni (N = 229).
English: Grade 4 neutropenia (< 500 cells/mm3) occurred in 9% of patients treated with Abraxane.
Maltese: 3) f'9% tal-pazjenti kkurati b'Abraxane.
English: Uncommon: Productive cough, exertional dyspnoea, sinus congestion, decreased breath sounds, pleural effusion, allergic rhinitis, hoarseness, nasal congestion, nasal dryness, wheezing, pulmonary emboli, pulmonary thromboembolism
Maltese: Mhux komuni: Sogħla bil-katarru, qtugħ ta' nifs bl-istrapazz, konġestjoni tas-sinus, tnaqqis fil-ħsejjes tan-nifs, ħruġ ta' likwidu mill-plewra, rinite allerġika, tinħanaq, konġestjoni nażali, nixfa nażali, tħarħir, emboli pulmonari, tromboemboliżmu pulmonari
English: There was no statistically significant difference in progression-free survival (by blinded radiologist assessment) and overall survival between the two treatment arms.
Maltese: Ma kien hemm ebda differenza statistikament sinifikanti fis-sopravivenza ħielsa mill-progressjoni (permezz ta' evalwazzjoni blinded minn radjologu) u s-sopravivenza globali bejn iż-żewġ partijiet talistudju dwar il-kura.
English: Table 3: Dose modifications for other adverse drug reactions in patients with pancreatic adenocarcinoma Adverse Drug Reaction (ADR)
Maltese: Tabella 3: Modifikazzjonijiet fid-doża għal reazzjonijiet avversi oħrajn għall-mediċini f'pazjenti b'adenokarċinoma tal-frixa Reazzjoni Avversa għallMediċina (ADR)
English: Uncommon: Contusion
Maltese: Komuni: Kolanġite
English: Febrile Neutropenia: Grade 3 or 4
Maltese: Mukożite ta' Grad 3
English: CNS metastases are generally not well controlled by systemic chemotherapy.
Maltese: Il-metastasijiet tas-CNS mhumiex ġeneralment ikkontrollati tajjeb bil-kimoterapija sistemika.
English: Because of potential serious adverse reactions in breast-feeding infants, Abraxane is contraindicated during lactation.
Maltese: Minħabba li jista' jkun hemm reazzjonijiet avversi serji fit-trabi li jkunu qed jerdgħu, Abraxane hu kontra-indikat waqt it-treddigħ.
English: Abraxane monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated (see section 4.4).
Maltese: Bħala mediċina waħidha, Abraxane hu indikat għall-kura ta' kanċer metastatiku tas-sider f'pazjenti adulti fejn il-kura inizjali tkun falliet u li għalihom it-terapija standard li jkun fiha anthracycline ma tkunx indikata (ara sezzjoni 4.4).
English: Following Abraxane administration to patients with solid tumours, paclitaxel is evenly distributed into blood cells and plasma and is highly bound to plasma proteins (94%).
Maltese: Wara l-għoti ta' Abraxane lil pazjenti b'tumuri solidi, paclitaxel jiġi ddistribwit b'mod konsistenti ġoċ-ċelluli tad-demm u l-plażma u jeħel ħafna mal-proteini tal-plażma (94%).
English: The recommended dose of Abraxane is 260 mg/m2 administered intravenously over 30 minutes every 3 weeks.
Maltese: Id-doża rrakkomandata ta' Abraxane hi ta' 260 mg/m li tingħata fil-vina fuq perijodu ta' 30 minuta kull 3 ġimgħat.
English: Monitor patients closely for signs and symptoms of pneumonitis.
Maltese: Immonitorja mill-qrib il-pazjenti kollha għal sinjali u sintomi ta' pulmonite.
English: Patients who have baseline neutrophil counts <1500 cells/mm3.
Maltese: Kien hemm newtropenija ta' Grad 4 (<500 ċellula/mm
English: *Survival [95% CI] (weeks)
Maltese: *Sopravivenza [95% CI] (ġimgħat)
English: 100 mg vial: Using a sterile syringe, 20 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should slowly be injected into a vial of Abraxane over a minimum of 1 minute.
Maltese: Kunjett ta' 100 mg: Bl-użu ta' siringa sterili, 20 ml ta' sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-infużjoni għandhom ikunu injettati bil-mod fil-kunjett ta' Abraxane fuq perijodu minimu ta' minuta.
English: For patients with total bilirubin > 5 x ULN or AST > 10 x ULN, there are insufficient data to permit dosage recommendations regardless of indication (see sections 4.4 and 5.2).
Maltese: Għal pazjenti b'bilirubina totali ta' > 5 x ULN jew AST ta' > 10 x ULN, m'hemmx biżżejjed dejta biex tippermetti rakkomandazzjonijiet dwar id-dożaġġ irrispettivament mill-indikazzjoni (ara sezzjonijiet 4.4 u 5.2).
English: Death or progression, n (%) Median PFS (95% CI) (months) HRA/T (95% CI)
Maltese: Globali, xhur (95% CI) HRA+G/G (95% CI)
English: A non-inferiority analysis was conducted for PFS and OS, with a pre-specified non-inferiority margin of 15%.
Maltese: Analiżi sussegwenti tan-noninferjorità twettqet għal PFS u OS, b'marġni ta' noninferjorità speċifikata minn qabel ta' 15%.
English: Following the analysis of case reports of scleroderma, published in literature during the reporting period, describing the temporal relationship with administration of the drug or reduction of the dose, a causal association for nab-paclitaxel is considered likely.
Maltese: Wara l-analiżi ta' rapporti tal-każijiet ta' skleroderma, ippubblikata fil-letteratura waqt il-perjodu ta' rappurtar, li tiddeskrivi r-relazzjoni temporali mal-għoti tal-mediċina jew it-tnaqqis tad-doża, assoċjazzjoni kawżali għal nab-paclitaxel hija meqjusa probabbli.
English: Uncommon: Dysuria, pollakiuria, haematuria, nocturia, polyuria, urinary incontinence
Maltese: Komuni ħafna: Newropatija periferali, newropatija, ipoestesija, parestesija
English: Paclitaxel belongs to a group of medicines called “taxanes” used in cancer.
Maltese: Paclitaxel jappartieni għal grupp ta' mediċini msejħa ‘taxanes' li jintużaw għall-kura tal-kanċer.
English: 2 Pneumonitis is evaluated using the SMQ interstitial lung disease (broad scope)
Maltese: Il-pnewmonite tiġi evalwata bl-użu ta' SMQ mard interstizjali tal-pulmuni (skop wiesgħa)
English: This should be taken into consideration if you are on a controlled sodium diet.
Maltese: Dan għandu jitqies jekk int tikkontrolla lammont ta' sodium li tieħu fid-dieta.
English: Very common: Neutropenia, anaemia, leukopenia, thrombocytopenia, lymphopenia, bone marrow suppression Common: Febrile neutropenia
Maltese: Komuni ħafna: Newtropenija, anemija, lewkopenja, tromboċitopenja, limfopenja, soppressjoni tal-mudullun
English: For treatment of non-small cell lung cancer Abraxane is given once every week (i.e. on days 1, 8 and 15 of a 21 day cycle), with carboplatin being given once every three weeks (i.e. only on day 1 of each 21-day cycle), immediately after the Abraxane dose has been given.
Maltese: Għal kura ta' kanċer tal-pulmun ta' ċelluli mhux żgħar, Abraxane jingħata darba f'ġimgħa (i.e. f'jiem 1, 8 u 15 ta' ċiklu ta' 21 jum), b'carboplatin li jingħata darba kull tliet ġimgħat (i.e. biss f'jum 1 ta' kull ċiklu ta' 21 jum), immedjatament wara li tkun ingħatat id-doża ta' Abraxane.
English: Abraxane in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.
Maltese: Abraxane flimkien ma' gemcitabine huwa indikat għall-kura primarja f'pazjenti adulti b'adenokarċinoma metastatika tal-frixa.
English: Blood and lymphatic system disorders1
Maltese: Disturbi tad-demm u tas-sistema limfatika
English: Abraxane was administered to patients (N=521) as an intravenous infusion over 30 minutes at a dose of 100 mg/m2 on Days 1, 8 and
Maltese: Abraxane ingħata lill-pazjenti (N=521) bħala infużjoni ġol-vini fuq perjodu ta' 30 minuta f'doża ta' 100 mg/m
English: Myalgia occurred in 24% of patients on Abraxane and was severe in 7% of cases.
Maltese: Ilmajalġja seħħet f'24% tal-pazjenti li kienu fuq Abraxane, u kienet severa f'7% tal-każijiet.
English: Stability of the reconstituted suspension in the infusion bag Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C-8°C followed by 4 hours at 25°C, protected from light.
Maltese: L-istabbiltà tas-suspensjoni rikostitwita fil-borża tal-infużjoni L-istabbiltà kimika u fiżika waqt l-użu ntweriet għal 24 siegħa f'temperatura ta' 2°C - 8°C segwiti minn 4 sigħat f'temperatura ta' 25°C, protetta mid-dawl.
English: Data from 106 patients accrued in two single-arm open-label studies and from 454 patients treated in a randomised Phase III comparative study are available to support the use of Abraxane in metastatic breast cancer.
Maltese: Informazzjoni fuq 106 pazjent li nġabret minn żewġ studji ta' fergħa waħda open-label u minn 454 pazjent mhux magħżula li kienu kkurati fi studju komparattiv ta' Fażi
English: There is limited experience of Abraxane/carboplatin use in patients 75 years or older.
Maltese: Hemm esperjenza limitata dwar l-użu ta' Abraxane/carboplatin f'pazjenti li għandhom 75 sena jew aktar.
English: • Abraxane is used together with a medicine called gemcitabine if you have metastatic cancer of the pancreas.
Maltese: • Abraxane jintuża flimkien ma' mediċina msejħa gemcitabine jekk għandek kanċer metastatiku tal-frixa.
English: Single-arm open-label studies
Maltese: Abraxane ingħata lill-pazjenti
English: Paclitaxel and/or its metabolites were excreted into the milk of lactating rats.
Maltese: Paclitaxel u/jew il-metaboliti tiegħu ġew imneħħija fil-ħalib ta' firien li jkunu qed ireddgħu.
English: Therefore, in the absence of a PK drug-drug interaction study, caution should be exercised when administering paclitaxel concomitantly with medicines known to inhibit either CYP2C8 or CYP3A4 (e.g. ketoconazole and other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, clopidogrel, cimetidine, ritonavir, saquinavir, indinavir, and nelfinavir) because toxicity of paclitaxel may be increased due to higher paclitaxel exposure.
Maltese: (eż. ketoconazole u antifungali oħrajn ta' imidazole, erythromycin, fluoxetine, gemfibrozil, clopidogrel, cimetidine, ritonavir, saquinavir, indinavir, u nelfinavir) minħabba li t-tossiċità ta' paclitaxel tista' tiżdied minħabba esponiment ta' paclitaxel ikbar.
English: Resume Abraxane at reduced dose when peripheral neuropathy improves to Grade 0 or 1 (see section 4.2).
Maltese: Erġa' kompli b'Abraxane b'doża mnaqqsa meta n-newropatija periferali titjieb għal Grad 0 jew 1 (ara sezzjoni 4.2).
English: Table 2: Dose modifications for neutropenia and/or thrombocytopenia at the start of a cycle or within a cycle for patients with pancreatic adenocarcinoma
Maltese: Tabella 2: Modifikazzjonijiet tad-doża għal newtropenija u/jew tromboċitopenija fil-bidu ta' ċiklu jew matul ċiklu għal pazjenti b'adenokarċinoma tal-frixa Ġurnata taċ
English: Pronounced hair loss ≥50% is expected for the majority of patients who experience alopecia.
Maltese: Telf notevoli ta' xagħar ≥ 50% hu mistenni għall-maġġoranza ta' pazjenti li jkollhom alopeċja.
English: Stability of the reconstituted suspension in the vial Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C-8°C in the original carton, protected from light.
Maltese: L-istabbiltà tas-suspensjoni rikostitwita fil-kunjett L-istabbiltà kimika u fiżika waqt l-użu ntweriet għal 24 siegħa f'temperatura ta' 2°C - 8°C fil-kaxxa tal-kartun oriġinali, protetta mid-dawl.
English: Of the 514 patients with non-small cell lung cancer in the randomized study who received Abraxane in combination with carboplatin, 31% were 65 years or older and 3.5% were 75 years or older.
Maltese: Mill-514-il pazjent b'kanċer tal-pulmun ta' ċelluli mhux żgħar fi studju li fih il-parteċipanti ntgħażlu b'mod każwali li rċivew Abraxane flimkien ma' carboplatin, 31% kellhom 65 sena jew aktar u 3.5% kellhom 75 sena jew aktar.
English: Very common: Diarrhoea, vomiting, nausea, constipation
Maltese: Komuni ħafna: Deidrazzjoni, tnaqqis fl-aptit, ipokalemija
English: The uncommon side effects may affect up to 1 in 100 people:
Maltese: L-effetti sekondarji mhux komuni jistgħu jaffettwaw sa 1 minn kull 100 persuna:
English: Population pharmacokinetic analyses for Abraxane indicate that gender, race (Asian vs. White), and type of solid tumours do not have a clinically important effect on systemic exposure (AUC and Cmax) of paclitaxel.
Maltese: Bajda), u t-tip ta' tumuri solidi m'għandhomx effett klinikament importanti fuq lesponiment sistemiku (AUC u Cmax) ta' paclitaxel.
English: Table 8 provides the frequency and severity of haematologic laboratory-detected abnormalities for patients treated with Abraxane in combination with gemcitabine or with gemcitabine.
Maltese: Tabella 8 tipprovdi l-frekwenza u s-severità tal-anormalitajiet ematoloġiċi osservati fil-laboratorju għal pazjenti kkurati b'Abraxane flimkien ma' gemcitabine jew b'gemcitabine waħdu.
English: Common: Pneumonia, bronchitis, upper respiratory tract infection, urinary tract infection
Maltese: Komuni: Pnewmonja, bronkite, infezzjonifil-parti ta' fuq tal-passaġġ respiratorju, infezzjoni tal-passaġġ urinarju
English: The following are the most common and important incidences of adverse reactions related to 421 patients with metastatic adenocarcinoma of the pancreas who were treated with 125 mg/m2 Abraxane in combination with gemcitabine at a dose of 1000 mg/m2 given on Days 1, 8 and 15 of each 28-day cycle in the phase III clinical study.
Maltese: Dawn li ġejjin huma l-inċidenzi l-aktar komuni u importanti tar-reazzjonijiet avversi marbuta ma' 421 pazjent b'adenokarċinoma metastatika tal-frixa li ġew ikkurati b'125 mg/m ta' Abraxane flimkien ma' gemcitabine b'doża ta' 1000 mg/m li ngħatat fi Ġranet 1, 8 u 15 ta' kull ċiklu ta' 28-ġurnata fil fażi
English: Table 6 lists adverse reactions associated with the administration of Abraxane to patients from studies in which Abraxane has been administered as monotherapy at any dose in any indication (N = 789).
Maltese: Tabella 6 telenka reazzjonijiet avversi wara l-għoti ta' Abraxane lil pazjenti, fi studji li fihom ingħata biss Abraxane bħala monoterapija fi kwalunkwe doża fi kwalunkwe indikazzjoni (N = 789).
English: After reconstitution, each ml of suspension contains 5 mg of paclitaxel formulated as albumin bound nanoparticles.
Maltese: Wara rrikostituzzjoni, kull ml ta' suspensjoni jkun fih 5 mg ta' paclitaxel ifformulat bħala nanopartikuli mwaħħla mal-albumina.
English: Pharmacokinetic/pharmacodynamic modelling using data from 125 patients with advanced solid tumours indicates that patients ≥ 65 years of age may be more susceptible to development of neutropenia within the first treatment cycle, although the plasma paclitaxel exposure is not affected by age.
Maltese: Mudell ta' farmakokinetika/farmakodinamika bl-użu ta' dejta minn 125 pazjent b'tumuri solidi avvanzati jindika li pazjenti ≥ 65 sena jafu jkunu iktar suxxettibbli għall-iżvilupp ta' newtropenija matul l-ewwel ċiklu ta' kura, għalkemm l-esponiment ta' paclitaxel fil-plażma mhuwiex affettwat mill-età.
English: Patients with pancreatic adenocarcinoma aged 75 years and older should be carefully assessed for their ability to tolerate Abraxane in combination with gemcitabine with special consideration to performance status, co-morbidities and increased risk of infections (see section 4.2 and 4.8).
Maltese: Pazjenti b'adenokarċinoma tal-frixa li għandhom 75 u iktar għandhom jiġu evalwati bir-reqqa għall-abbiltà tagħhom li jittolleraw Abraxane flimkien ma' gemcitabine b'konsiderazzjoni speċjali għall-istat ta' prestazzjoni, komorbożitajiet u riskju ogħla ta' infezzjonijiet (ara sezzjoni 4.2 u 4.8)
English: Very common: Weight decreased, alanine aminotransferase increased Common: Aspartate aminotransferase increased, blood bilirubin increased, blood creatinine increased
Maltese: Tnaqqis fil-piż, żieda f'alanine aminotransferase Komuni: Żieda f'aspartate aminotransferase, żieda fil-bilirubina fid-demm, żieda fil-krejatinina fid-demm
English: Common: Haemoptysis, epistaxis, cough
Maltese: Komuni: Takikardija, arritmija, takikardija supraventrikulari
English: Pharmacokinetic/pharmacodynamic modeling indicates that there is no correlation between hepatic function (as indicated by the baseline albumin or total bilirubin level) and neutropenia after adjusting for Abraxane exposure.
Maltese: Immudellar farmakokinetiku/farmakodinamiku jindika li m'hemm l-ebda korrelazzjoni bejn ilfunzjoni tal-fwied (kif indikat mill-albumina fil-linja bażi jew il-livell ta' bilirubina) u newtropenija wara li tiġi aġġustata għall-esponiment ta' Abraxane.
English: Common: Decreased weight, increased alanine aminotransferase, increased aspartate aminotransferase, decreased haematocrit, decreased red blood cell count, increased body temperature, increased gamma-glutamyltransferase, increased blood alkaline phosphatase
Maltese: Tnaqqis fil-piż, żieda fl-alanine aminotransferase, żieda fl-aspartate aminotransferase, tnaqqis fl-ematokrit, tnaqqis fl-għadd taċ-ċelluli ħomor tad-demm, żieda fit-temperatura tal-ġisem, żieda fil-gamma-glutamyltransferase, żieda fl-alkaline phosphatase fid-demm
English: Of the 421 patients with pancreatic adenocarcinoma in the randomized study who received Abraxane in combination with gemcitabine, 41% were 65 years and older and 10% were 75 years and older.
Maltese: Mill-421 pazjent b'adenokarċinoma tal-frixa fl-istudju li fih il-parteċipanti ntgħażlu b'mod każwali, li rċivew Abraxane flimkien ma' gemcitabine, 41% kellhom 65 sena u iktar u 10% kellhom 75 sena u iktar.
English: Pneumonitis occurred in 1% of patients when Abraxane was used as monotherapy and in 4% of patients when Abraxane was used in combination with gemcitabine.
Maltese: Kien hemm pulmonite f'1% tal-pazjenti meta Abraxane intuża bħala monoterapija u f'4% meta Abraxane intuża flimkien ma' gemcitabine.
English: Abraxane should not be administered on Day 1 of a cycle until absolute neutrophil count (ANC) is ≥1500 cells/mm3 and platelet count is ≥100,000 cells/mm3.
Maltese: Abraxane m'għandux jingħata f'Jum 1 ta' ċiklu sakemm l-għadd assolut tan-newtrofili (ANC - absolute neutrophil count) ikun ta' ≥1500 ċellula/mm u l-għadd tal-plejtlits ikun ta' ≥100,000
English: Reduce doses 1 dose level
Maltese: Ara Tabella 1 għat-tnaqqis fil-livelli ta' doża
English: Common: Peripheral sensory neuropathy, headache, dysgeusia, dizziness, peripheral motor neuropathy, ataxia, sensory disturbance, somnolence
Maltese: Komuni: Newropatija sensorja periferali, uġigħ ta' ras, disturb fis-sens tattogħma, sturdament, newropatija tal-moviment tad-dirgħajn u s-saqajn, atassja, disturb tas-sensi, ngħas tqil
English: Each ml of Abraxane contains approximately 4.2 mg of sodium.
Maltese: Kull ml ta' Abraxane fih madwar 4.2 mg ta' sodium.
English: The reconstituted suspension in the intravenous drip may be stored in a refrigerator (2°C-8°C) for up to 24 hours protected from light.
Maltese: Is-suspensjoni rrikostitwita fid-dripp li jingħata fil-vina tista' tinħażen fi friġġ (2 °C - 8 °C) sa 24 siegħa protetta mid-dawl.
English: Proporti on of
Maltese: Okkorrenz a
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Celgene Europe B.V.
Maltese: Celgene Distribution B.V.
English: The usual dose is for breast cancer is 260 mg/m2 of body surface area given over a 30 minute period.
Maltese: Id-doża li ssoltu tingħata għall-kanċer tas-sider hija ta' 260 mg/m ta' erja tas-superfiċje tal-ġisem mogħtija fuq perijodu ta' 30 minuta.
English: • Blood clot
Maltese: x ULN.
English: For Grade 3 sensory neuropathy, withhold treatment until resolution to Grade 1 or 2, followed by a dose reduction for all subsequent courses.
Maltese: Għal newropatija sensorja ta' Grad 3, waqqaf il-kura sakemm il-marda ssir ta' Grad 1 jew 2, imbagħad naqqas id-doża għall-bqija talkorsijiet kollha tal-kura.
English: Unopened vials of Abraxane are stable until the date indicated on the package when the vial is kept in the outer carton in order to protect from light.
Maltese: Kunjetti mhux miftuħa ta' Abraxane huma stabbli sad-data indikata fuq il-pakkett meta l-kunjett jibqa' fil-kartuna ta' barra biex tipproteġih mid-dawl.
English: The concurrent recommended dose of gemcitabine is 1000 mg/m2 administered intravenously over 30 minutes immediately after the completion of Abraxane administration on Days 1, 8 and 15 of each 28-day cycle.
Maltese: Id-doża rrakkomandata fl-istess ħin ta' gemcitabine hi ta' 1000 mg/m li tingħata ġol-vina fuq 30 minuta eżatt wara li jingħata Abraxane fi Ġranet 1, 8 u 15 ta' kull ċiklu ta' 28-ġurnata.
English: Abraxane (260 mg/m2)
Maltese: (260 mg/m
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/428/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/0/428/001
English: Common: Infection, urinary tract infection, folliculitis, upper respiratory tract infection, candidiasis, sinusitis
Maltese: Infezzjoni, infezzjoni fl-apparat urinarju, follikulite, infezzjoni fl-apparat respiratorju ta' fuq, kandidijasi, sinusite
English: Common: Dehydration, decreased appetite, hypokalaemia Uncommon: Hypophosphataemia, fluid retention, hypoalbuminaemia, polydipsia, hyperglycaemia, hypocalcaemia, hypoglycaemia, hyponatraemia
Maltese: Komuni: Deidrazzjoni, nuqqas t'aptit, ipokalemja Mhux komuni: Ipofosfatemija, akkumulazzjoni tal-fluwidu, ipoalbuminemja, polidipsja, ipergliċemja, ipokalċimja, ipogliċemja, iponatremja
English: The effect of hepatic impairment on population pharmacokinetics of Abraxane was studied in patients with advanced solid tumours.
Maltese: L-effett tal-indeboliment tal-fwied fuq il-farmakokinetika tal-popolazzjoni ta' Abraxane ġie studjat f'pazjenti b'tumuri solidi avvanzati.
English: A multicenter, randomized, open-label study was conducted in 1052 chemotherapy-naive patients with Stage IIIb/IV non-small cell lung cancer.
Maltese: Twettaq studju multiċentriku, li fih il-parteċipanti ntgħażlu b'mod każwali, open-label, fuq 1052 pazjent li qatt ma rċivew kimoterapija fil-passat, b'kanċer tal-pulmun ta' ċelluli mhux żgħar fi Stadju IIIb/IV.
English: Based on non-compartmental PK analysis, the plasma clearance of paclitaxel with Abraxane was larger (43%) than that following a solvent-based paclitaxel injection and its volume of distribution was also higher (53%).
Maltese: Ibbażat fuq analiżi PK mhux kompartimentali, it-tneħħija ta' paclitaxel mill-plażma b'Abraxane kienet ikbar (43%) minn dik b'injezzjoni ta' paclitaxel ibbażata fuq is-solvent, u l-volum tad-distribuzzjoni tiegħu kien ukoll ogħla (53%).
English: • medicine used for heartburn or stomach ulcers (e.g. cimetidine)
Maltese: • mediċina li jintużaw għal qrusa fl-istonku jew ulċeri fl-istonku (eż. cimetidine)
English: Each vial contains 100 mg of paclitaxel formulated as albumin bound nanoparticles.
Maltese: Kull kunjett fih 100 mg ta' paclitaxel ifformulat bħala nanopartikuli mwaħħla mal-albumina.