FrancophonIA/ELRC3.0 huggingface dataset:
English: Thereby, non-inferiority was shown in the ITT population for PFS, but not for OS. At the time of analysis of the OS data, death had occurred in 56% of the patients in the group treated with paclitaxel micellar compared to 60% in the group treated with solvent-based paclitaxel (ITT population).
Maltese: Meta saret l-analiżi tad-data ta'OS, 56 % tal-pazjenti fil-grupp ittrattati b'paclitaxel miċellari kienu mietu meta mqabbla ma' 60 % fil-grupp ittrattati b'paclitaxel ibbażat fuq solvent (popolazzjoni ITT).
English: In the absence of in vivo studies addressing inhibition of CYP2B6 and CYP2C9, the concomitant use of Apealea and substances metabolised primarily by these CYP enzymes should be exercised with caution.
Maltese: Fin-nuqqas ta' studji in vivo li jindirizzaw l-inibizzjoni ta' CYP2B6 u CYP2C9, l-użu konkomitanti ta' Apealea u sustanzi metabolizzati primarjament minn dawn l-enzimi CYP għandu jiġi eżerċitat b'kawtela.
English: Unopened vials: Store in a refrigerator (2 °C - 8 °C).
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna Aħżen fi friġġ (2 °C - 8 °C).
English: Alternatively, the vial may be placed on a shaker and rotated for up to 20 minutes, while being protected from light (orbital shake pattern; 200-250 rpm).
Maltese: tħawwid orbitali; 200-250 rpm).
English: For patients with total bilirubin > 5 × ULN or AST > 10 × ULN, there are insufficient data to permit dosage recommendations (see sections 4.4 and 5.2).
Maltese: Għal pazjenti b'bilirubina totali > 5 × ULN jew AST > 10 × ULN, m'hemmx biżżejjed data biex jiġu permessi rakkomandazzjonijiet għad-dożaġġ (ara sezzjonijiet 4.4 u 5.2).
English: • low blood levels of potassium, magnesium or sodium
Maltese: • livelli baxxi ta' potassium, magnesium jew sodium • telf eċċessiv ta' ilma (deidrazzjoni)
English: Uncommon: Status epilepticus, coma, cerebrovascular accident, peripheral sensorimotor neuropathy, lethargy, hypotonia, neurotoxicity, polyneuropathy, polyneuropathy in malignant disease, burning sensation, somnolence, cognitive disorder, facial palsy, encephalopathy, hydrocephalus
Maltese: Mhux komuni: Status epilepticus, koma, aċċident ċerebrovaskulari, newropatija sensorimotorika periferika, letarġija, ipotonija, newrotossiċità, polinewropatija,
English: • a heart rhythm disorder causing irregular rapid activity in the upper heart chambers
Maltese: • disturb tar-ritmu tal-qalb li jikkawża attività rapida irregolari fil-kompartimenti ta' fuq tal-qalb
English: • depression, sleeplessness, anxiety
Maltese: Mhux komuni: Dipressjoni, insonnja, ansjetà
English: Compared to patients with normal hepatic function, hepatically impaired patients with total bilirubin > 1.5 × ULN have an increase in mean paclitaxel AUC of approximately 20%.
Maltese: Meta mqabbel ma' pazjenti b'funzjoni tal-fwied normali, pazjenti indeboliti fil-fwied b'bilirubina totali > 1.5 × ULN għandhom żieda fl-AUC medja ta' paclitaxel ta' madwar 20 %.
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 1).
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 1).
English: During and after infusion of Apealea, paclitaxel rapidly leaves the plasma compartment with a distribution half-life of about 0.6 hours.
Maltese: Waqt u wara l-infużjoni ta' Apealea, paclitaxel jitlaq malajr mill-kompartiment tal-plażma b'half life ta' distribuzzjoni ta' madwar 0.6 sigħat.
English: The solution should be administered by an intravenous infusion over approximately one hour (120−140 drops/min).
Maltese: Is-soluzzjoni għandha tingħata permezz ta' infużjoni ġol-vini għal madwar siegħa (120−140 qatra/min).
English: In vitro studies using human microsomes have shown these derivatives to have inhibitory activity on CYP2B6, CYP2C8, CYP2C9, and to a lesser extent on CYP2D6.
Maltese: CYP2C8, CYP2C9, u sa livell inqas fuq CYP2D6.
English: Apealea is a cancer medicine containing the active substance paclitaxel, which belongs to a group of medicines called taxanes.
Maltese: Apealea huwa mediċina kontra l-kanċer li fih is-sustanza attiva paclitaxel, li tappartjeni għal grupp ta' mediċini msejħa taxanes.
English: Patients who experience neutropenia (neutrophil count < 1.5 × 109/L), febrile neutropenia or thrombocytopenia (platelet count < 100 × 109/L) during treatment should have the next treatment cycle delayed until neutrophil counts recover to ≥ 1.5 × 109/L and platelets recover to ≥ 100 × 109/L.
Maltese: Pazjenti li jesperjenzaw newtropenija (għadd tan-newtrofili < 1.5 × 109/L), newtropenija bid-deni jew tromboċitopenja (għadd tal-pjastrini < 100 × 109/L) waqt it-trattament għandhom ikollhom iċ-ċiklu ta'
English: When solvent-based paclitaxel was given after cisplatin, patients showed a more profound myelosuppression and an approximately 20% decrease in paclitaxel clearance.
Maltese: Meta paclitaxel ibbażat fuq solvent ingħata wara cisplatin, il-pazjenti wrew majelosoppressjoni aktar profonda u tnaqqis ta' madwar 20 %
English: Continue to swirl the vial until the powder is completely dissolved., Alternatively, the vial may be placed on a shaker and rotated for up to 20 minutes, while being protected from light (orbital shake pattern; 200-250 rpm).
Maltese: B'mod alternattiv, il-kunjett jista' jitqiegħed fuq shaker u jiddawwar sa 20 minuta, filwaqt li jiġi protett mid-dawl (mudell ta'
English: These patients should be vigilantly monitored by physicians for the occurrence of cardiac events.
Maltese: Dawn il-pazjenti għandhom jiġu mmonitorjati b'attenzjoni għall-okkorrenza ta' avvenimenti kardijaċi.
English: Febrile neutropeniaa, leukopeniaa, thrombocytopeniaa, granulocytopenia, anaemiaa
Maltese: tromboċitopenjaa, granuloċitopenja, anemijaa
English: After reconstitution, each mL of solution contains 1 mg of paclitaxel (micellar).
Maltese: Wara r-rikostituzzjoni, kull mL ta' soluzzjoni fih 1 mg ta' paclitaxel (miċellari).
English: Gastrointestinal adverse reactions are very common.
Maltese: Sintomi gastrointestinali Reazzjonijiet avversi gastrointestinali huma komuni ħafna.
English: In the study, 35% of the patients in the paclitaxel micellar group and 30% of the patients in the solvent-based paclitaxel group, respectively, received GCSF to treat neutropenia.
Maltese: Antiemetiċi u antinawsjanti Fl-istudju, 35 % tal-pazjenti fil-grupp ta' paclitaxel miċellari u 30 % tal-pazjenti fil-grupp ta'
English: Median time to death or disease progression [months] (95% CI)
Maltese: Żmien medjan għal mewt jew progressjoni tal-marda [xhur] (95 % CI) Proporzjon ta' periklu (95 % CI)
English: EXP After reconstitution: use immediately.
Maltese: EXP Wara r-rikostituzzjoni: uża immedjatament.
English: If neuropathy is observed, follow dose reduction recommendations in Table 1.
Maltese: Jekk tiġi osservata newropatija, segwi r-rakkomandazzjonijiet għat-tnaqqis fid-doża f'Tabella 1.
English: N-(all-trans-retinoyl)-L-cysteic acid methyl ester sodium salt N-(13-cis-retinoyl)-L-cysteic acid methyl ester sodium salt Sodium hydroxide (for pH adjustment)
Maltese: N-(all-trans-retinoyl)-L-cysteic acid methyl ester sodium salt N-(13-cis-retinoyl)-L-cysteic acid methyl ester sodium salt
English: The median number of cycles with paclitaxel/carboplatin treatment for patients receiving GCSF was 6 in both groups.
Maltese: In-numru medjan ta' ċikli bit-trattament b'paclitaxel/carboplatin għall-pazjenti li rċevew GCSF kien 6 fiż-żewġ gruppi.
English: Do not shake.
Maltese: Neoplażmi beninni,
English: Based on the published literature, in vitro studies indicate that the presence of cimetidine, ranitidine, dexamethasone, or diphenhydramine does not affect protein binding of paclitaxel.
Maltese: Abbażi tal letteratura ppubblikata, studji in vitro jindikaw li l-preżenza ta' cimetidine, ranitidine, dexamethasone, jew diphenhydramine ma taffettwax l-irbit mal-proteina ta' paclitaxel.
English: During the course of the pivotal study, 46% of the peripheral neuropathies as well as the majority (78%) of the associated reactions resolved.
Maltese: Matul l-istudju pivotali, 46 % tan-newropatiji periferika kif ukoll il-maġġoranza (78 %) tar-reazzjonijiet assoċjati ġew riżolti.
English: Delay of next cycle Apealea/carboplatin
Maltese: Dewmien taċ-ċiklu li jmiss Apealea/carboplatin
English: Apealea should not be interchanged with other paclitaxel formulations.
Maltese: Apealea m'għandux jintuża minflok formulazzjonijet oħra ta' paclitaxel.
English: Administration sets containing a 15 µm polyamide fluid filter should be used.
Maltese: Għandhom jintużaw settijiet tal-għoti li fihom filtru tal-fluwidu ta' polyamide ta' 15 µm.
English: There are limited data of Apealea in non-Caucasian patients and current data is insufficient to recommend additional dose adjustments (see section 4.4).
Maltese: Hemm data limitata ta' Apealea f'pazjenti mhux Kawkasi u d-data attwali mhijiex biżżejjed biex jiġu rrakkomandati aġġustamenti fid-doża addizzjonali (ara sezzjoni 4.4).
English: Withhold treatment until recovery to < grade 2
Maltese: Waqqaf it-trattament sal-irkupru għal < grad 2
English: Apealea has been given as monotherapy in a total of 132 patients at doses ranging between 90 mg/m2 in a 3-week regimen to weekly doses of 250 mg/m2 for various indications.
Maltese: Apealea ngħata bħala monoterapija f'total ta' 132 pazjent b'dożi li jvarjaw bejn 90 mg/m2 f'reġimen ta' 3 ġimgħat għal dożi kull ġimgħa ta' 250 mg/m2 għal diversi indikazzjonijiet.
English: Severe reactions, such as hypotension requiring treatment, dyspnoea requiring bronchodilators, angioedema or generalised urticaria require immediate discontinuation of paclitaxel and initiation of symptomatic treatment.
Maltese: Reazzjonijiet severi, bħal ipotensjoni li jeħtieġu trattament, dispnea li teħtieġ bronkodilaturi, anġjoedema jew urtikarja ġeneralizzata jeħtieġu twaqqif immedjat ta' paclitaxel u bidu ta' trattament sintomatiku.
English: All
Maltese: Tqala
English: Repeat dose toxicity studies have shown non-reversible, toxic effects on male reproductive organs.
Maltese: Studji ta' effett tossiku minn dożi ripetuti juru effetti tossiċi mhux riversibbli fuq l-organi riproduttivi tal-irġiel.
English: • If you have any further questions, ask your doctor or nurse.
Maltese: • Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib jew lill-infermier tiegħek.
English: • headache
Maltese: • puplesija
English: • skin reddening, rash, itching, nettle-rash
Maltese: • ħmura tal-ġilda, raxx, ħakk, ħorriqija
English: In addition, a study with a crossover design compared total and unbound paclitaxel concentrations in plasma after a 1-hour infusion of Apealea 260 mg/m2 with those after a 1-hour infusion of albumin-bound paclitaxel at the same dose.
Maltese: Barra minn hekk, studju bi tfassil inkroċjat qabbel konċentrazzjonijiet totali u mhux marbuta ta' paclitaxel fil-plażma wara infużjoni ta' siegħa ta' Apealea 260 mg/m2 ma' dawk wara infużjoni ta' siegħa ta' paclitaxel marbut ma' albumina bl-istess doża.
English: The formation of these metabolites is catalysed by CYP2C8 and CYP3A4.
Maltese: Il-formazzjoni ta' dawn il-metaboliti tiġi kkatalizzata minn CYP2C8 u
English: Median time to death [months] (95% CI)
Maltese: Żmien medjan għal mewt [xhur] (95 % CI)
English: From a microbiological point of view, unless the method of opening and reconstituting precludes the risks of microbial contamination, the product should be used immediately.
Maltese: Mil-lat mikrobijoloġiku, il-prodott għandu jintuża immedjatament, sakemm il-metodu ta' ftuħ u ta' rikostituzzjoni ma jipperkludix irriskji ta' kontaminazzjoni mikrobijoloġika.
English: Any grade 3 toxicity except nausea, vomiting and diarrhoea
Maltese: Kwalunkwe tossiċità ta' grad 3 ħlief nawsja, rimettar u dijarea
English: There is no relevant use of paclitaxel in the paediatric population for the indications of epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer.
Maltese: M'hemm l-ebda użu rilevanti ta' paclitaxel fil-popolazzjoni pedjatrika għal indikazzjonijiet ta' kanċer tal-ovarji epiteljali, kanċer peritoneali primarju u kanċer tat-tubu fallopjan.
English: • blood vessel disorders, such as:
Maltese: • disturbi tal-vażi, bħal:
English: There are limited data on the use of Apealea in non-Caucasian patients.
Maltese: Hemm data limitata dwar l-użu ta' Apealea f'nisa pazjenti mhux Kawkasi.
English: • rapid heartbeat
Maltese: • fsada f'ġog
English: With regard to age, the population model indicated an approximate 5% decline in paclitaxel elimination rate for each 10-year increase in age compared to the median age of 56 years of the study.
Maltese: 10 snin fl-età meta mqabbel mal-età medjana ta' 56 sena tal-istudju.
English: However, a population pharmacokinetics study of 168 patients (86 males and 82 females) treated with solvent-based paclitaxel has been reported.
Maltese: (86 irġiel u 82 nisa) ittrattati b'paclitaxel ibbażat fuq solvent.
English: Neutropenia is a dose-dependent and dose-limiting adverse reaction.
Maltese: Newtropenija hija reazzjoni avversa li tiddependi mid-doża u hija limitata mid-doża.
English: Treatment should be directed at the major anticipated toxicities, which are nausea, vomiting, diarrhoea, myelosuppression, peripheral sensory neuropathy and peripheral neuropathy.
Maltese: It-trattament għandu jiġi iffukat lejn it-tossiċitajiet antiċipati maġġuri, li huma nawsja, rimettar, dijarea, majelosoppressjoni, newropatija sensorja periferika u newropatija periferika.
English: Alopecia is a very common adverse reaction and occurs early in treatment.
Maltese: Alopeċja hija reazzjoni avversa komuni ħafna u sseħħ kmieni fit-trattament.
English: Haematology
Maltese: Ċitotossiku
English: Limited data are available on use in patients ≥ 75 years (2% of the patients in the study).
Maltese: Hemm data limitata disponibbli dwar l-użu f'pazjenti ta' ≥ 75 sena (2 % tal-pazjenti fl-istudju).
English: How to store Apealea
Maltese: X'fih Apealea
English: • tissue swelling caused by excess fluid
Maltese: • ġilda xotta, disturb tad-difer
English: Very common: Astheniaa, fatiguea, infusion site reactiona,d Common:
Maltese: Komuni ħafna: Astenijaa, għejaa, reazzjoni fis-sit tal-infużjonia,d Komuni:
English: Immune system disorders Common:
Maltese: Disturbi fis-sistema immuni
English: Uncommon: Death, multi-organ failure, oedema, administration site pain, catheter site haemorrhage, catheter site oedema, local swelling, generalised oedema, hernia, chest pain, influenza like illness, localised oedema, hypothermia, chills, feeling hot
Maltese: Mhux komuni: Mewt, insuffiċjenza ta' ħafna organi, edema, uġigħ fis-sit tal-għoti, emorraġija fis-sit tal-kateter, edema fis-sit tal-kateter, nefħa lokali, edema ġeneralizzata, ernja, uġigħ fis-sider, mard bħall-influwenza, edema lokalizzata, ipotermja, sirdat, tħoss is-sħana
English: Moderate cases may require premedication with corticosteroids, antihistamines and/or H2 antagonists for the following treatment cycles.
Maltese: Każijiet moderati jistgħu jeħtieġu premedikazzjoni b'kortikosterojdi, antistamini u/jew antagonisti ta' H2 għaċ-ċikli ta' trattament li jmiss.
English: d Includes the following preferred terms: infusion site pain, infusion site phlebitis, infusion site reaction, infusion site discolouration, infusion site erythema, infusion site extravasation, infusion site inflammation, infusion site oedema, infusion site paraesthesia, infusion site irritation, and infusion site rash.
Maltese: d Tinkludi t-termini ppreferuti li ġejjin: uġigħ fis-sit tal-infużjoni, flebite fis-sit tal-infużjoni, reazzjoni fis-sit tal-infużjoni, skulurament fis-sit tal-infużjoni, eritema fis-sit tal-infużjoni, estravażazzjoni fis-sit tal-infużjoni, infjammazzjoni fis-sit tal-infużjoni, edema fis-sit tal-infużjoni, paresteżija fis-sit talinfużjoni, irritazzjoni fis-sit tal-infużjoni, u raxx fis-sit tal-infużjoni.
English: After reconstitution, this medicine contains approximately up to 1.6 g sodium (component of cooking salt) per dose.
Maltese: Wara r-rikostituzzjoni, din il-mediċina fiha sa madwar 1.6 g sodium (komponent ta' melħ tat-tisjir)
English: Most hypersensitivity reactions related to Apealea were mild to moderate (see section 4.4).
Maltese: Il-biċċa l-kbira tar-reazzjonijiet ta' sensittività eċċessiva relatati ma' Apealea kienu ħfief sa moderati (ara sezzjoni 4.4).
English: • regular blood tests to ensure it is safe for you to continue treatment
Maltese: • testijiet tad-demm regolari sabiex jiġi żgurat li huwa sigur għalik biex tkompli t-trattament
English: In comparison to the patients receiving solvent-based paclitaxel, there were more patients in the group receiving paclitaxel micellar who experienced haematological toxicities with grade 3 and 4.
Maltese: Bi tqabbil mal-pazjenti li rċevew paclitaxel ibbażat fuq solvent, kien hemm aktar pazjenti fil-grupp li rċevew paclitaxel miċellari li esperjenzaw tossiċitajiet ematoloġiċi bi grad 3 u 4.
English: Inject the required amount of reconstituted Apealea into an empty, sterile ethylene-vinyl acetate (EVA) bag.
Maltese: Injetta l-ammont meħtieġ ta' Apealea rikostitwit f'borża ta' ethylene-vinyl acetate (EVA) sterili vojta.
English: PFS and OS results in the PP population are summarised in Figures 3 and 4.
Maltese: Ir-riżultati tal-PFS u l-OS fil-popolazzjoni PP huma miġbura filqosor fil-Figuri 3 u 4.
English: There were more reports of infusion site pain in the group receiving paclitaxel micellar as compared to the group treated with solvent-based paclitaxel (8% and 1%, respectively).
Maltese: Kien hemm aktar rapporti ta' wġigħ fis-sit tal-infużjoni fil-grupp li kien qed jirċievi paclitaxel miċellari meta mqabbel mal-grupp ittrattat b'paclitaxel ibbażat fuq solvent (8 % u 1 %,
English: Patients that have total bilirubin > 5 × ULN or AST > 10 × ULN should not be treated with paclitaxel.
Maltese: Pazjenti li jkollhom bilirubina totali > 5 × ULN jew AST > 10 × ULN m'għandhomx jiġu ttrattati b'paclitaxel.
English: • sensation of heaviness in the legs
Maltese: • sensazzjoni ta' toqol fir-riġlejn
English: In vitro studies using different cell systems have shown paclitaxel to be clastogenic inducing chromosomal aberrations, micronuclei and DNA damage.
Maltese: Studji in vitro permezz ta' sistemi ta' ċelluli differenti wrew li paclitaxel huwa klastoġeniku billi jinduċi aberrazzjonijiet kromożomiċi, mikronuklei u ħsara fid-DNA.
English: Uncommon: Disseminated intravascular coagulationa, pancytopenia, haematotoxicity, coagulopathy
Maltese: panċitopenija, ematotossiċità, koagulopatija
English: • Periodic safety update reports (PSURs)
Maltese: • Rapporti perjodiċi ta' aġġornament dwar is-sigurtà (PSURs) Ir-rekwiżiti biex jiġu ppreżentati
English: Most of the patients enrolled in the study had ECOG performance status of 0 or 1 (≥ 96%), in similar proportions between the treatment arms.
Maltese: Il-biċċa l-kbira tal-pazjenti li rreġistraw fl-istudju kellhom status tal-prestazzjoni ECOG ta' 0 jew 1 (≥ 96 %), fi proporzjonijiet simili bejn il-fergħat ta' trattament.
English: Apealea is given to you by a doctor or nurse by a slow drip (infusion) into a vein.
Maltese: Apealea jingħatalek minn tabib jew infermier permezz ta' dripp bil-mod (infużjoni) ġo vina.
English: Ensure that the solution is clear and place a light protective-bag over the EVA infusion bag.
Maltese: Kun ċert li s-soluzzjoni tkun ċara u poġġi borża li tipproteġi mid-dawl fuq il-borża tal-infużjoni EVA.
English: Cytotoxic Apealea should not be interchanged with other paclitaxel formulations.
Maltese: Ladarba jinfetaħ, Apealea huwa rrakkomandat li jintuża immedjatament.
English: Paclitaxel is distributed equally between plasma and blood as described in published in vitro data.
Maltese: Paclitaxel jiġi distribwit b'mod indaqs bejn il-plażma u d-demm kif deskritt f'data in vitro ippubblikata.
English: Using a sterile syringe, inject 60 mL of solution for reconstitution per vial.
Maltese: Billi tuża siringa sterili, injetta 60 mL ta' soluzzjoni għar-rikostituzzjoni għal kull kunjett.
English: Hypersensitivity Uncommon: Anaphylactic shock, drug hypersensitivity
Maltese: Mhux komuni: Xokk anafilattiku, sensittività eċċessiva għal mediċina
English: Paclitaxel is excreted in human milk.
Maltese: carboplatin ma jistgħux jiġu esklużi.
English: • epileptic fit lasting longer than five minutes or more than one fit within five minutes
Maltese: • aċċessjoni epilettika li ddum iktar minn ħames minuta jew aktar minn aċċessjoni waħda f'ħames minuti
English: Uncommon: Angioedema, rash generalised, skin discolouration, hyperhidrosis, rash papular, dermatitis bullous, swelling face, pigmentation disorder, dry skin, cold sweat, livedo reticularis, nail disorder, pruritus allergic, skin disorder
Maltese: Mhux komuni: Anġjoedema, raxx ġeneralizzat, telf ta' kulur talġilda, iperidrożi, raxx papulari, dermatite bulluża, nefħa fil-wiċċ, disturb tal-pigmentazzjoni, ġilda xotta, għaraq kiesaħ, livedo retikulari, disturb tad difer, ħakk allerġiku, disturb tal-ġilda
English: • epithelial ovarian cancer - a cancer of the ovary, the organ that produces a woman's egg cells
Maltese: • kanċer tal-ovarji epiteljali - kanċer tal-ovarju, l-organu li jipproduċi ċ-ċelluli tal-bajda tal-mara
English: • abnormally high levels of nitrogen-containing compounds in the blood
Maltese: • livelli għoljin b'mod anormali ta' komposti li fihom nitroġenu fid-demm
English: Uncommon: Vaginal haemorrhage, pelvic pain, breast pain
Maltese: Mhux komuni: Emorraġija vaġinali, uġigħ fil-pelvis, uġigħ fis-sider
English: There is very little information available on whether the elimination of paclitaxel differs between races.
Maltese: Hemm ftit ferm informazzjoni disponibbli dwar jekk l-eliminazzjoni ta' paclitaxel tvarjax bejn ir-razez.
English: Local reactions at the infusion site are very common during Apealea infusions.
Maltese: Reazzjonijiet lokali fis-sit tal-infużjoni huma komuni ħafna waqt l-infużjonijiet ta' Apealea.
English: Abdominal pain, constipation, abdominal pain upper, flatulence, dry mouth, stomatitis
Maltese: Uġigħ addominali, stitikezza, uġigħ addominali finnaħa ta' fuq, flatulenza, ħalq xott, stomatite
English: Administration in patients with hepatic impairment defined as total bilirubin > 1 to ≤ 5 × ULN and AST ≤ 10 × ULN (see section 4.2) should therefore be performed with caution and they should be closely monitored with regard to increased liver impairment and myelosuppression.
Maltese: L-għoti f'pazjenti b'inbedoliment tal-fwied definit bħala bilirubina totali > 1 sa ≤ 5 × ULN u AST ≤ 10 × ULN (ara sezzjoni 4.2) għandu jsir b'kawtela u għalhekk dawn għandhom jiġu mmonitorjati mill-qrib fir-rigward ta' indeboliment tal-fwied miżjud u majelosoppressjoni.
English: Uncommon: Hyponatraemia, hypokalaemia, hypomagnesaemia,
Maltese: ħruq, sonnolenza, disturb konjittiv, paraliżi tal-wiċċ, enċefalopatija, idroċefalu
English: Probability of progression-free survival
Maltese: Probabbiltà ta' sopravivenza mingħajr progressjoni
English: Uncommon: Azotaemia
Maltese: Mhux komuni: Ażotemija
English: A non-inferiority analysis was conducted for PFS in the per-protocol (PP) population with pre-specified non-inferiority margin.
Maltese: Saret analiżi ta' nuqqas ta' inferjorità għall-PFS fil-popolazzjoni skont il-protokoll (PP, per-protocol) b'marġni ta' nuqqas ta' inferjorità speċifikata minn qabel.
English: The dose-dependency of frequency and severity of neurotoxicity was not studied for Apealea, but has been observed for other paclitaxel formulations in other indications.
Maltese: Apealea, iżda ġiet osservata għal formulazzjonijiet oħra ta' paclitaxel f'indikazzjonijiet oħra.
English: Uncommon: Vision blurred, eye irritation, ocular discomfort, lacrimation increased
Maltese: dispepsja, fikaloma, disturb funzjonali intestinali,
English: For patients with moderate to severe impairment (total bilirubin > 1.5 to ≤ 5 × ULN and AST ≤ 10 × ULN), a 20% reduction in dose is recommended.
Maltese: Għal pazjenti b'indeboliment moderat sa sever (bilirubina totali > 1.5 sa ≤ 5 × ULN u