FrancophonIA/ELRC3.0 huggingface dataset:
English: The terminal half-life of paclitaxel after Apealea infusion varied about 5-fold between the subjects, 5-23 hours.
Maltese: Il-half life terminali terminali ta' paclitaxel wara infużjoni ta' Apealea varjat madwar 5 darbiet bejn l-individwi, 5-23 siegħa.
English: This amounted to a 14% decline in an 86-year-old patient compared to one aged 56.
Maltese: Dan ammonta għal tnaqqis ta' 14 % f'pazjent ta' 86 sena meta mqabbel ma' wieħed ta' 56 sena.
English: Apealea contains sodium
Maltese: Apealea fih is-sodium
English: Apealea is not recommended for children and adolescents under 18 years, because it has not been studied in this age group.
Maltese: Apealea mhuwiex irrakkomandat għal tfal u adolexxenti taħt it-18-il sena peress li ma ġiex studjat f'dan il-grupp ta' età.
English: In the clinical study, the proportion of patients receiving six treatment cycles was 81% in the group treated with paclitaxel micellar and 87% in the group receiving solvent-based paclitaxel.
Maltese: Fl-istudju kliniku, il-proporzjon ta' pazjenti li rċevew sitt ċikli ta' trattament kien 81 % fil-grupp ittrattat b'paclitaxel miċellari u 87 % fil-grupp li rċieva paclitaxel ibbażat fuq solvent.
English: • fluoxetine: a medicine to treat depression
Maltese: • fluoxetine: mediċina biex tittratta d-dipressjoni
English: When reconstituted, this medicinal product contains up to approximately 1.6 g sodium per dose (0.9 g/m2 BSA; 3.6 mg per mL), equivalent to 80% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Meta jiġi rikostitwit, dan il-prodott mediċinali fih sa madwar 1.6 g sodium għal kull doża (0.9 g/m2 BSA; 3.6 mg għal kull mL), ekwivalenti għal 80% tat-teħid massimu rakkomandat ta' kuljum tal-WHO ta' 2 g sodium għal adult.
English: Other associated reactions were reported in 10% of the patients and were mostly (98%) mild to moderate (CTCAE grade ≤ 2).
Maltese: Reazzjonijiet assoċjati oħra ġew irrappurtati f'10 % tal-pazjenti u kienu l-aktar (98 %) ħfief sa moderati (CTCAE grad ≤ 2).
English: Apealea in combination with carboplatin is indicated for the treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer (see section 5.1).
Maltese: Apealea flimkien ma' carboplatin huwa indikat għat-trattament ta' pazjenti adulti bl-ewwel rikaduta ta' kanċer tal-ovarji epiteljali sensittiv għall-platinu, kanċer peritoneali primarju u kanċer tat-tubu fallopjan (ara sezzjoni 5.1).
English: Apealea 60 mg powder for solution for infusion.
Maltese: Apealea 60 mg trab għal soluzzjoni għall-infużjoni.
English: Pharmacotherapeutic group: Antineoplastic agents, taxanes, ATC code: L01CD01 Mechanism of action
Maltese: Sustanzi antineoplastiċi, taxanes, Kodiċi ATC:
English: dehydration, decreased appetite
Maltese: Dispnea, konġestjoni nażali
English: Administering paclitaxel concomitantly with medicines known to induce either CYP2C8 or CYP3A4 (e.g. rifampicin, carbamazepine, phenytoin, efavirenz, nevirapine) is not recommended because efficacy may be compromised because of lower paclitaxel exposures.
Maltese: L-għoti ta' paclitaxel flimkien ma' mediċini magħrufa li jinibixxu jew CYP2C8 jew CYP3A4 (eż. rifampicin, carbamazepine, phenytoin, efavirenz, nevirapine)
English: Haematological toxicityb neutrophil count < 1.5 × 109/L or platelet count < 100 × 109/L or febrile neutropenia
Maltese: Tossiċità ematoloġikab għadd tan-newtrofili < 1.5 × 109/L jew għadd tal-pjastrini < 100 × 109/L jew newtropenija bid-deni
English: Based on literature data, no clinically relevant pharmacokinetic interaction between paclitaxel and carboplatin is expected.
Maltese: Abbażi ta' data mil-letteratura, mhija mistennija l-ebda interazzjoni farmakokinetika klinikament rilevanti bejn paclitaxel u carboplatin.
English: Apealea is indicated to be used in combination with carboplatin (see section 4.1).
Maltese: Apealea huwa indikat biex jintuża flimkien ma' carboplatin (ara sezzjoni 4.1).
English: Apealea 60 mg powder for solution for infusion paclitaxel
Maltese: Apealea 60 mg trab għal soluzzjoni għall-infużjoni paclitaxel
English: • skin infections, including infections at the infusion site
Maltese: • infezzjonijiet tal-ġilda, inkluż infezzjonijiet fis-sit tal-infużjoni
English: Listing of adverse reactions System Organ Class
Maltese: Elenkar ta' reazzjonijiet avversi Sistema tal-Klassifika talOrgani
English: − sodium hydroxide (for pH adjustment) See section 2 “Apealea contains sodium”.
Maltese: Ara sezzjoni 2 “Apealea fih is-sodium”.
English: Excipients: N-(all-trans-retinoyl)-L-cysteic acid methyl ester sodium salt, N-(13-cis-retinoyl)-L-cysteic acid methyl ester sodium salt, sodium hydroxide.
Maltese: N-(all-trans-retinoyl)-L-cysteic acid methyl ester sodium salt, N-(13-cis-retinoyl)-L-cysteic acid methyl ester sodium salt, sodium hydroxide.
English: Paclitaxel causes myelosuppression (primarily neutropenia).
Maltese: Paclitaxel jikkawża majelosoppressjoni (primarjament newtropenija).
English: After reconstitution, each mL of solution contains up to approximately 3.60 mg (0.157 mmol) sodium.
Maltese: Wara r-rikostituzzjoni, kull mL ta' soluzzjoni fih sa madwar 3.60 mg (0.157 mmol) sodium.
English: Limited data are available on use in patients ≥ 75 years.
Maltese: Hemm data limitata disponibbli dwar l-użu f'pazjenti ta' ≥ 75 sena.
English: Probability of survival
Maltese: Probabbiltà ta' sopravivenza
English: • efavirenz, nevirapine, ritonavir, saquinavir, indinavir, nelfinavir: medicines to treat HIV
Maltese: • cimetidine: mediċina biex tnaqqas l-aċidu fl-istonku • efavirenz, nevirapine, ritonavir, saquinavir, indinavir, nelfinavir: mediċini biex jittrattaw infezzjoni tal-HIV
English: Of the 391 patients with ovarian cancer in the randomised study who received Apealea in combination with carboplatin, 13% were between 65 and 74 years old.
Maltese: Apealea flimkien ma' carboplatin, 13 % kellhom bejn 65 u 74 sena.
English: General disorders and administration site conditions Asthenia and fatigue were very common and occurred in 23% and 11% of patients, respectively.
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Astenija u għeja kienu komuni ħafna u seħħew fi 23 % u 11 % tal-pazjenti, rispettivament.
English: • low muscle tone, facial palsy
Maltese: • ton tal-muskolu baxx, paraliżi tal-wiċċ
English: Other metabolites are 3'-p-hydroxypaclitaxel and 6α,3'-p-dihydroxypaclitaxel.
Maltese: 6α,3'-p-dihydroxypaclitaxel.
English: PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties
Maltese: .1 Karatteristiċi farmakodinamiċi
English: Uncommon: Cardiac arrest, cardiac failure chronic, cyanosis, atrial fibrillation, sinus tachycardia, palpitations, sinus bradycardia
Maltese: Mhux komuni: Attakk tal-qalb, insuffiċjenza kardijaka kronika, ċijanożi, fibrillazzjoni atrijali, takikardija tas-sinus,
English: • taste disturbance
Maltese: Disturbi vaskulari
English: Other medicines and Apealea
Maltese: Mediċini oħra u Apealea
English: For CTCAE grade ≥ 2 sensory or motor neuropathy withhold treatment until resolution to < grade 2, followed by a dose reduction for all subsequent courses (see section 4.2).
Maltese: Għal newropatija sensorja jew motorika ta' CTCAE grad ≥ 2, waqqaf it-trattament sa riżoluzzjoni għal < grad 2, segwita minn tnaqqis fid-doża għall-korsijiet sussegwenti kollha (ara sezzjoni 4.2).
English: Based on limited data, Cmax and AUC increased with dose after 1-hour infusions of Apealea in doses ranging from 150 to 275 mg/m2.
Maltese: Abbażi ta' data limitata, is-Cmax u l-AUC żdiedu bid-doża wara infużjonijiet ta' siegħa ta' Apealea b'dożi li jvarjaw minn 150 sa 275 mg/m2.
English: A population pharmacokinetics study with albumin-bound paclitaxel demonstrated that patients with mild hepatic impairment (total bilirubin > 1 to ≤ 1.5 × ULN) have an elimination rate in the normal range.
Maltese: Studju tal-farmakokinetika tal-popolazzjoni b'paclitaxel marbut ma' albumina wera li pazjenti b'indeboliment tal-fwied ħafif (bilirubina totali > 1 sa ≤ 1.5 × ULN) għandhom rata ta' eliminazzjoni fil-medda normali.
English: Each carton contains 1 glass vial with powder equivalent to 60 mg of paclitaxel.
Maltese: Kull kartuna fiha kunjett tal-ħġieġ 1 bi trab ekwivalenti għal 60 mg ta' paclitaxel.
English: Compatibility with administration sets made of DEHP-free PVC (i.e. polyvinyl chloride without the plasticizer di-(2-ethylhexyl) phthalate) has been demonstrated.
Maltese: Intweriet kompatibbiltà ma' settijiet tal-għoti magħmula minn PVC mingħajr DEHP (jiġifieri polyvinyl chloride mingħajr il-plastifikant di-(2-ethylhexyl) phthalate).
English: • ketoconazole, or other medicines to treat fungal infections
Maltese: • ketoconazole, jew mediċini oħra biex jittrattaw infezzjonijiet fungali
English: Second 71 59
Maltese: Kollha 311 179
English: Erythema, rash, pruritus, urticaria
Maltese: Komuni ħafna: Dijareaa, nawsjaa, rimettara
English: Premedication may be considered in patients who have previously experienced gastrointestinal symptoms when being treated with cytotoxic medicinal products.
Maltese: Il-premedikazzjoni tista' tiġi kkunsidrata f'pazjenti li preċedentement esperjenzaw sintomi gastrointestinali meta kienu qed jiġu ttrattati bi prodotti mediċinali ċitotossiċi.
English: Paclitaxel is an antimicrotubule agent that promotes the assembly of microtubules from tubulin dimers and stabilises microtubules by preventing depolymerisation.
Maltese: Paclitaxel huwa sustanza antimikrotubula li tippromwovi l-ġbir ta' mikrotubuli minn dimeri tattubulina u tistabbilizza l-mikrotubuli billi tipprevjeni d-depolimerizzazzjoni.
English: Approximately 86% of patients experienced adverse reactions.
Maltese: Madwar 86 % tal-pazjenti esperjenzaw reazzjonijiet avversi.
English: Hazard Ratio (95% CI)
Maltese: Xhur medjana (CI ta' 95 %)
English: * Can persist beyond 6 months of paclitaxel discontinuation.
Maltese: * Tista' tippersisti għal aktar minn 6 xhur minn meta jitwaqqaf paclitaxel.
English: Peripheral sensory neuropathy and peripheral neuropathy are very common adverse reactions.
Maltese: Newropatija sensorja periferika u newropatija periferika huma reazzjonijiet avversi komuni ħafna.
English: After preparation, each millilitre of solution contains 1 mg of paclitaxel (micellar).
Maltese: kull millilitru ta' soluzzjoni fih 1 mg ta' paclitaxel (miċellari).
English: Forest plot for PFS by relapse (PP population)
Maltese: Figura 3. Forest plot għal PFS skont ir-rikaduta (popolazzjoni PP)
English: • lung inflammation, influenza, tonsil inflammation
Maltese: • infjammazzjoni fil-pulmun, influwenza, infjammazzjoni fit-tunsilli
English: Disseminated intravascular coagulation (DIC), often in association with sepsis or multi-organ failure, has been reported.
Maltese: Ġiet irrappurtata koagulazzjoni intravaskulari mxerrda (DIC), spiss f'assoċjazzjoni ma' sepsis jew insuffiċjenza ta' ħafna organi.
English: Unopened vial
Maltese: n Avveni menti
English: The paclitaxel infusion was followed by carboplatin after an interval of 30 minutes in both treatment arms.
Maltese: L-infużjoni ta' paclitaxel ġiet segwita minn carboplatin wara intervall ta' 30 minuta fiż-żewġ fergħat ta' trattament.
English: In studies with Apealea, 45% of patients reported alopecia during therapy.
Maltese: Fi studji b'Apealea, 45 % tal-pazjenti rrapurtaw alopeċja waqt it-terapija.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu
English: Patients with severe renal impairment (GFR < 30 mL/min) should not be treated with paclitaxel (see section 5.2).
Maltese: Pazjenti b'indeboliment tal-kliewi sever (GFR < 30 mL/min) m'għandhomx jiġu ttrattati b'paclitaxel (ara sezzjoni 5.2).
English: This was in agreement with the mean fu after albumin-bound paclitaxel infusion which varied between 5.5% and 4.5% over time.
Maltese: albumina li varja bejn 5.5 % u 4.5 % maż-żmien.
English: Clear type I glass vial with a silicon coated butyl rubber stopper, an aluminium overseal and a plastic flip-off cap containing powder equivalent to 60 mg of paclitaxel.
Maltese: Kunjett tal-ħġieġ ċar tat-tip I b'tapp tal-gomma butyl miksi bis-silikon, siġill tal-aluminju u tapp tat-tip flip-off tal-plastik li fih trab ekwivalenti għal 60 mg ta' paclitaxel.
English: Therefore, 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: Għalhekk, għandha tiġi eżerċitata kawtela meta paclitaxel jingħata flimkien ma' mediċini magħrufa li jinibixxu jew CYP2C8 jew CYP3A4 (eż. ketoconazole u antifungali ta' imidazole oħra, erythromycin, fluoxetine, gemfibrozil, clopidogrel, cimetidine, ritonavir, saquinavir, indinavir, u nelfinavir) għax it-tossiċità ta' paclitaxel tista' tiżdied minħabba esponiment ogħla għal paclitaxel.
English: Non-inferiority analyses on PFS and OS in a randomised trial in patients with recurrent epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer (PP population)a
Maltese: Analiżi ta' nuqqas ta' inferjorità fuq PFS u OS fi prova fejn il-pazjenti ntgħażlu b'mod każwali f'pazjenti b'kanċer tal-ovarji epiteljali rikorrenti, kanċer peritoneali primarju u kanċer tat-tubu fallopjan (popolazzjoni PP)a
English: Uncommon: Respiratory failure, epistaxis, cough, rhinorrhoea, oropharyngeal pain, pharyngeal disorder, asphyxia, bronchospasm, dysphonia, rhinitis allergic, allergic cough, oropharyngeal discomfort Gastrointestinal disorders Very common: Diarrhoeaa, nauseaa, vomitinga
Maltese: Mhux komuni: Insuffiċjenza respiratorja, epistassi, sogħla, rinorea, uġigħ orofarinġeali, disturb farinġeali, asfissija, bronkospażmu, disfonija, rinite allerġika, sogħla allerġika, skumdità orofarinġeali
English: Not known:
Maltese: Tnaqqis fid-doża:
English: Uncommon: Alanine aminotransferase increased a See Description of selected adverse reactions.
Maltese: Mhux komuni: Żieda fl-alalanineaminotrasferase a Ara Deskrizzjoni ta' reazzjonijiet avversi magħżula.
English: One vial contains 60 mg of paclitaxel.
Maltese: Kunjett wieħed ta' trab fih 60 mg paclitaxel.
English: Uncommon: Haemarthrosis, musculoskeletal discomfort, sensation of heaviness
Maltese: Mhux komuni: Emartrożi, skumdità muskoloskeletali, sensazzjoni ta' toqol
English: The most common clinically significant adverse reactions associated with the use of Apealea are neutropenia, gastrointestinal disorders, peripheral neuropathy, arthralgia/myalgia, and infusion site reactions.
Maltese: Sommarju tal-profil tas-sigurtà Ir-reazzjonijiet avversi klinikament sinifikanti l-aktar komuni assoċjati mal-użu ta' Apealea huma newtropenija, disturbi gastrointestinali, newropatija periferika, artralġja/mijalġija, u reazzjonijiet fis-sit tal-infużjoni.
English: Hypotension, flushing, phlebitis, vein pain, hyperaemia
Maltese: Ipotensjoni, fwawar, flebite, uġigħ fil-vini, iperemija
English: • low body temperature
Maltese: • temperatura tal-ġisem baxxa
English: Breast-feeding must be discontinued for the duration of therapy.
Maltese: It-treddigћ gћandu jieqaf tul it-terapija.
English: Forest plot for OS by relapse (PP population)
Maltese: Forest plot għal OS skont ir-rikaduta (popolazzjoni PP)
English: Uncommon: Metastatic pain
Maltese: Mhux komuni: Uġigħ metastiku
English: The median number of cycles with administration of GCSF was 3 (1;6) and the mean value 3.1, each in both groups.
Maltese: In-numru medjan ta' ċikli bl-għoti ta' GCSF kien 3 (1;6) u l-valur medju kien 3.1, kull wieħed fiż-żewġ gruppi.
English: The non-inferiority criterion was met for PFS with the upper bound limit of the one-sided 97.5% confidence interval (CI) for the associated hazard ratio being less than 1.2.
Maltese: Il-kriterju ta' nuqqas ta' inferjorità ntlaħaq għall-PFS bil-limitu superjuri ta' 97.5 % intervall ta' kunfidenza (CI) minn naħa waħda għall-proporzjon ta' periklu assoċjat li jkun inqas minn 1.2.
English: Peripheral sensory neuropathy represented the most common reaction and was reported in 16% of patients.
Maltese: Newropatija sensorja periferika rrappreżentat ir-reazzjoni l-aktar komuni u ġiet irrappurtata f'16 % tal-pazjenti.
English: • symptoms of allergic reaction during the infusion, such as:
Maltese: • sintomi ta' reazzjoni allerġika waqt l-infużjoni, bħal:
English: • cisplatin: a medicine to treat cancer
Maltese: • cisplatin: mediċina biex tittratta l-kanċer
English: The pH of lactated or acetated Ringer's solution must be in the range of 5.0 to 7.5, and acceptable ion concentrations of calcium and magnesium are listed below (Table 5).
Maltese: Il-pH tas-soluzzjoni lattata jew aċetata ta' Ringer trid tkun fil-medda ta' 5.0 sa 7.5, u konċentrazzjonijiet ta' jone aċċettabbli ta' calcium u magnesium huma elenkati hawn taħt (Tabella 5).
English: In this limited number of patients, anorexia, fatigue, myalgia, arthralgia, peripheral sensory neuropathy, and diarrhoea were observed more frequently compared to patients younger than 65 years.
Maltese: pazjenti, ġew osservati anoressija, għeja, mijalġija, artralġja, newropatija sensorja periferika, u dijarea b'mod aktar frekwenti meta mqabbel ma' pazjenti iżgħar minn 65 sena.
English: Heart failure has been observed in some patients receiving Apealea.
Maltese: Insuffiċjenza kardijaka ġiet osservata f'xi pazjenti li rċevew Apealea.
English: A population pharmacokinetics study with albumin-bound paclitaxel demonstrated that patients with mild and moderate renal impairment (creatinine clearance ≥ 30 to < 90 mL/min) have an elimination rate similar to that of patients with normal renal function.
Maltese: Studju talfarmakokinetika tal-popolazzjoni b'paclitaxel marbut ma' albumina wera li pazjenti b'indeboliment tal-kliewi ħafif u moderat (tneħħija tal-kreatinina ≥ 30 sa < 90 mL/min) għandhom rata ta' eliminazzjoni simili għal dik ta' pazjenti b'funzjoni tal-fwied normali.
English: tingling, rash, bleeding
Maltese: raxx, fsada
English: No clinical studies in patients with hepatic impairment have been undertaken with Apealea (see sections 4.2 and 4.4).
Maltese: Ma sar l-ebda studju kliniku f'pazjenti b'indeboliment tal-fwied b'Apealea (ara sezzjonijiet 4.2 u 4.4).
English: Uncommon: Circulatory collapse, venous thrombosis, vasculitis, thrombosis, hypertension, deep vein thrombosis, lymphoedema, phlebitis superficial, thrombophlebitis, blood pressure fluctuation, haemorrhage, angiopathy, hot flush, pallor
Maltese: Mhux komuni: Kollass ċirkolatorju, trombożi venuża, vaskulite, trombożi, ipertensjoni, trombożi profonda tal-vini, limfoedema, flebite superfiċjali, tromboflebite, ċaqliq fil-pressjoni tad-demm, emorraġija, anġjopatija, fwawar ta' sħana, pallidità
English: To reach room temperature, let the vials stand protected from light for approximately 15 to 20 minutes not above 25 °C.
Maltese: Sabiex jilħqu temperatura ambjentali, ħalli l-kunjetti jibqgħu protetti mid-dawl għal madwar 15 sa 20 minuta f'temperatura mhux 'il fuq minn 25 °C.
English: In the pivotal clinical study, patients were either treated with Apealea (paclitaxel micellar) at a dose of 250 mg/m2 in combination with carboplatin or with solvent-based paclitaxel at a dose of 175 mg/m2 in combination with carboplatin (N = 391 in each arm).
Maltese: Il-pazjenti ġew ittrattati kull tliet ġimgħat għal sitt ċikli, jew b'Apealea 250 mg/m2 mogħti bħala infużjoni ġol-vini għal siegħa (N = 391) jew b'paclitaxel ibbażat fuq solvent 175 mg/m2 mogħti bħala infużjoni għal tliet sigħat (N = 391).
English: Acceptable ion concentrations for calcium and magnesium in lactated and acetated Ringer's solutions suitable for reconstitution
Maltese: Konċentrazzjonijiet ta' jone aċċettabbli għal calcium u magnesium f'soluzzjonijiet ta'
English: Anaemia as serious adverse event occurred in 5% of the patients, thrombocytopenia and leukopenia in 3% and 6% of the patients, respectively.
Maltese: tromboċitopenja u lewkopenija fi 3 % u 6 % tal-pazjenti, rispettivament.
English: Steps 3 to 6 should not be more than 30 minutes.
Maltese: Passi 3 sa 6 m'għandhomx idumu aktar minn 30 minuta.
English: Very common: Arthralgiaa, myalgiaa Common:
Maltese: Komuni ħafna: Artralġjaa, mijalġijaa Komuni:
English: 5.3 Preclinical safety data
Maltese: 5.3 Data preklinika dwar is-sigurtà
English: Package leaflet: Information for the user Apealea 60 mg powder for solution for infusion paclitaxel
Maltese: Informazzjoni għall-utent Apealea 60 mg trab għal soluzzjoni għall-infużjoni paclitaxel
English: For appropriate use of carboplatin, the prescriber is advised to consult the prescribing information for carboplatin as well.
Maltese: carboplatin, huwa rakkomandat li min se jippreskrivih jikkonsulta l-informazzjoni tal-preskrizzjoni għal carboplatin ukoll.
English: Only reconstitute Apealea using one of the following commercially available solutions for reconstitution: - sodium chloride 9 mg/mL (0.9%) solution suitable for infusion; - lactated Ringer's solution suitable for infusion; - acetated Ringer's solution suitable for infusion.
Maltese: - soluzzjoni xierqa għall-infużjoni ta' 9 mg/mL (0.9 %) sodium chloride; - soluzzjoni lattata ta' Ringer xierqa għall-infużjoni;
English: Hypoaesthesia, dizziness, paraesthesia, peripheral motor neuropathy, dysgeusia, headache
Maltese: Ipoesteżija, sturdament, paresteżija, newropatija motorika periferika, disgewżja, uġigħ ta' ras
English: The tissue distribution is extensive, with a volume of distribution on the terminal elimination phase of about 155 L/m2 corresponding to about 280 L for an average patient with a body surface area of 1.8 m2.
Maltese: Id-distribuzzjoni tat-tessut hija estensiva, b'volum ta' distribuzzjoni fuq il-fażi ta' eliminazzjoni terminali ta' madwar 155 L/m2 li jikkorrispondi għal madwar 280 L għal pazjent medju b'erja tas-superfiċje tal-ġisem ta' 1.8 m2. Għalhekk, madwar 1 % biss tal-paclitaxel fil-ġisem jitqiegħed fil-plażma waqt il-fażi ta' eliminazzjoni.
English: The biotransformation and elimination of paclitaxel have been reported in published studies; paclitaxel is mainly eliminated by hepatic metabolism and biliary excretion.
Maltese: Il-bijotrasformazzjoni u l-eliminazzjoni ta' paclitaxel ġew irrappurtati fi studji ppubblikati; paclitaxel jiġi eliminat prinċipalment minn metaboliżmu tal-fwied u eskrezzjoni biljari.
English: b The dose of carboplatin should be reduced by 1 AUC unit for treatment cycles following the occurrence of febrile neutropenia or low platelet count (< 75 × 109/L).
Maltese: b Id-doża ta' carboplatin għandha titnaqqas b'unità 1 ta' AUC għal ċikli ta' trattament wara l okkorrenza ta' newtropenija bid-deni jew għadd baxx tal-pjastrini (< 75 × 109/L).
English: Patients treated with paclitaxel and cisplatin may have an increased risk of renal failure as compared to cisplatin alone in gynaecological cancers.
Maltese: Pazjenti ttrattati b'paclitaxel u cisplatin jista' jkollhom riskju miżjud ta' insuffiċjenza tal-kliewi meta mqabbel ma' cisplatin waħdu f'kanċers ġinekoloġiċi.
English: Infections and infestations Uncommon: Sepsis, abscess, pneumonia, influenza, respiratory tract infection viral, herpes simplex, infusion site cellulitis, tonsillitis, urinary tract infection, skin infection, cystitis
Maltese: Mhux komuni: Sepsis, axxess, pulmonite, influwenza, infezzjoni virali fl-apparat respiratorju, herpes simplex, ċellulite fis-sit tal-infużjoni, tonsillite, infezzjoni fl apparat tal-awrina, infezzjoni tal-ġilda, ċistite
English: Apealea should be administered first, then carboplatin.
Maltese: L-ewwel għandu jingħata Apealea, imbagħad carboplatin.