FrancophonIA/ELRC3.0 huggingface dataset:
English: Levels of the extractable plasticiser DEHP [di-(2-ethylhexyl)phthalate] increase with time and concentration when dilutions are prepared in PVC containers.
Maltese: Livelli ta' plastiżer li jlissi ta' DEHP [di-(2-ethylhexyl)phthalate] jiżdid mal-ħin u konċentrazzjoni meta t-tgħammid isir f'reċipjenti tal-PVC.
English: The other ingredients are polyoxyl castor oil, citric acid (anhydrous) and ethanol.
Maltese: Polyoxylated castor oil Citric acid (anidru) ethanol.
English: In the second study, 599 patients with stage IIIB or IV disease were randomised to receive cisplatin (75 mg/m2) and etoposide (100 mg/m2; n= 200), or cisplatin (75 mg/m2) and low-dose paclitaxel (135 mg/m2; n= 198), or cisplatin (75 mg/m2) and high-dose paclitaxel (250 mg/m2) with G-CSF (n= 201).
Maltese: Fit-tieni studju, 599 pazjent bil-marda fi stadju IIIB jew IV kienu magħżula bl-addoċċ biex jircievu cisplatin (75 mg/m2) u etoposide (100 mg/m2; n=200) jew cisplatin (75 mg/m2) u doża baxxa ta' paclitaxel (135 mg/m2; n=198), jew cisplatin (75 mg/m2) u doża għolja ta' paclitaxel (250 mg/m2) b'G-CSF (n=201).
English: Tel.: +34 93 480 88 33
Maltese: Combino Pharm, S.L. Tel.: +34 93 480 88 33
English: Common: dry mouth, mouth ulceration, melaena, dyspepsia
Maltese: Komuni: ħalq xott, ulċerazzjoni fil-ħalq, melaena, dispepsja
English: Very common: infection (including herpes simplex, oral candidiasis, pharyngitis, rhinitis) Common: flu syndrome
Maltese: Komuni ħafna: infezzjoni (li jinkludi herpes simplex, kandidjasi orali, farinġite, rinite)
English: The median time to progression in the core population was 468 days (95 % CI 257-NE).
Maltese: Iż-żmien medjan għal firxa fil-popolazzjoni ewlenija kien ta' 468 jum (95 % CI 257-NE).
English: Rare: pleural effusion, lung fibrosis Very rare*: cough, pulmonary hypertension
Maltese: Rari: nixxiegħa mill-plewre, fibrożi tal-pulmun Rari ħafna*: sogħla, pressjoni pulmonari għolja ħafna
English: BATCH NUMBER Batch Number:
Maltese: NUMRU TAL-LOTT Lott:
English: Neuropathy, primarily peripheral sensory neuropathy, occurs very commonly and is usually of mild to moderate intensity.
Maltese: Newropatija, prinċipalment newropatija sensorjali periferika sseħħ b'mod komuni ħafna u ġeneralment tkun ta' intensità minn ħafifa sa moderata.
English: EXPIRY DATE Use by:
Maltese: DATA META JISKADI Uża sa:
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 150 mg/25 ml
Maltese: U KONTENUT Konċentrat għal soluzzjoni għall-infużjoni 150 mg/25 ml
English: Further data on the potential of drug interactions between paclitaxel and other CYP 3A4 substrates/inhibitors are limited.
Maltese: Tagħrif addizzjonali dwar effetti oħrajn potenzjali tal-mediċina bejn paclitaxel u inibituri u sottostrati oħrajn ta' CYP 3A4 huwa ristrett.
English: There was no advantage in survival (9.5 vs. 9.9 months) or progression free survival (5.1 vs. 5.0 months) with cisplatin/paclitaxel vs cisplatin/tenoposide.
Maltese: Ma kienx hemm vantaġġ fis-sopravivenza (9.5 vs 9.9 xhur) jew sopravivenza mingħajr ma jkompli jinfirex (5.1 vs 5.0 xhur) b'cisplatin /paclitaxel vs cisplatin/tenoposide.
English: Based on in vitro studies, the degree of plasma protein binding has been reported to range from 88 to 98 %.
Maltese: Msejsa fuq studji in vitro, il-grad ta' rabta ta' proteina fil-plażma ġie rapportat li jinsab fil-firxa ta' bejn 88 sa 98 %.
English: The clinical response rate was 21.7 % (CI: 14.7 - 31.1 %), median time to progression was 4.1 months (CI: 3.3 - 4.9 months) and the median survival time was 13.4 months (CI: 11.5 - 15.0 months).
Maltese: Ir-rata ta' rispons kliniku kienet ta' 21,7 % (CI: 14.7 - 31.1%), iżżmien medjan għal firxa kienet ta' 4.1 xhur (CI: 3.3 - 4.9 xhur) u ż-żmien ta' sopravivenza medjan kien ta' 13.4 xhur (CI: 11.5 - 15.
English: The overall success rate (complete or partial response) after 15 cycles of treatment was 57 % (CI: 44 - 70 %) in liposomal anthracycline-resistant patients.
Maltese: Ir-rata ta suċċess globali (rispons sħiħ jew parzjali) wara 15-il ċiklu ta' kura kienet ta'57 % (CI 44 - 70%) f'pazjenti, reżistenti għal liposomali t'anthracycline.
English: Although the two different paclitaxel posologies were not compared with each other directly, in both trials patients treated with paclitaxel in combination with cisplatin had a significantly longer time to progression (Study 1: median 15.3 months vs 11.5 months, p< 0.001; Study 2: median 17 months vs 13 months, p< 0.001), and longer survival time (Study 1: median 36 months vs 26 months, p= 0.0016; Study 2: median 36 months vs 24 months, p< 0.001), and in Study 1 a significantly higher response rate (Study 1: 59 % vs 45 %, p= 0.014; Study 2: 60 % vs 50 %, NS), when compared with standard therapy.
Maltese: Studju 2: medjan 36 xahar vs 24 xahar, p<0.001), u fi Studju 1, rata ta' rispons sinifikament ogħla (Studju 1: 59 % vs 45 %, p=0.014; Studju 2: 60 % vs 50 %, NS) meta paragunat mat-terapija standard.
English: over 3 hours) followed by cisplatin (75 mg/m2) or control.
Maltese: (75 mg/m2) jew kontroll.
English: Severe neuropathy and severe paraesthesia occurred in 3 % and 5 % of patients, respectively.
Maltese: Newropatija severa u parasteżija severa seħħew fi 3 % u 5 % tal-pazjenti, rispettivament.
English: Paxene administered as a 3-hour infusion as second-line chemotherapy in two clinical studies and were considered possibly or probably related to Paxene.
Maltese: Paxene mogħti bħala infużjoni ta 3 sigħat bħala t-tieni kura kimjoterapewtika ppreferuta fi studju kliniku u kienu kkonsidrati li possibilment jew probabilment huma relatati ma' Paxene.
English: Insufficient information is available on interactions with other protease inhibitors.
Maltese: M'hemmx biżżejjed informazzjoni disponibbli fuq interazzjonijiet ma' impedituri ta' protease oħrajn.
English: In the first study, 332 patients with locally advanced or metastatic NSCLC were randomised to receive cisplatin (80 mg/m2) in combination with teniposide (100 mg/m2; n= 166), or cisplatin (80 mg/m2) and paclitaxel (175 mg/m2; n= 166).
Maltese: Fl-ewwel studju, 332 pazjent li jbatu minn NSCLC avvanzat lokalment jew li kien jinsab fi stadju metastatiku kienu magħżula b'addoċċ biex jirċievu cisplatin (80 mg/m2) flimkien ma' teniposide (100 mg/m2, n-166), jew cisplatin (80 mg/m2) u paclitaxel (175 mg/m2; n=166).
English: Paxene should be diluted in sodium chloride 9 mg/ml (0.9%) solution for injection, glucose 50 mg/ml (5%) solution for infusion, or glucose 50 mg/ml (5%) in Ringer's solution for injection to a final concentration of 0.3 to 1.2 mg/ml.
Maltese: Paxene għandu jiġi dilwit f'9 mg/ml (0.9 %) w/v klorur tas-sodju għall-infużjoni, 50 mg/ml (5 %) glukows, soluzzjoni għall-infużjoni, jew 50 mg/ml (5 %) glukows għal soluzzjoni għal injezzjoni ta' Ringer għal konċentrazzjoni finali ta' 0.3 sa 1.2 mg/ml.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 100 mg/16.7 ml
Maltese: U KONTENUT Konċentrat għal soluzzjoni għall-infużjoni. 100 mg/16.7 ml
English: Others
Maltese: DETENTURI
English: Paxene should be administered through an in-line filter with a microporous membrane not greater than 0.22 µm.
Maltese: Paxene għandu jiġi mogħti f'filtru fil-pajp b'membrana mikroporuża li mhiex akbar minn 0.22 µm.
English: Severe neutropenia (< 500 cells/mm3) occurred in 26 % of patients treated with Paxene during the entire treatment period.
Maltese: Newtropenija serja (<500 ċellula/mm3) seħħet f'26 % ta' pazjenti kkurati b'Paxene matul il-perijodu kollu.
English: Paxene 6 mg/ml concentrate for solution for infusion Paclitaxel
Maltese: Paxene 6 mg/ml konċentrat għal soluzzjoni għall-infużjoni paclitaxel
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 6 mg/ml of paclitaxel (30 mg of paclitaxel in 5 ml or 100 mg of paclitaxel in 16.7 ml or 150 mg of paclitaxel in 25 ml or 300 mg of paclitaxel in 50 ml).
Maltese: U KWANTITATTIVA Kunjett wieħed biss li fih 6 mg/ml ta' paclitaxel (30 mg ta' paclitaxel f'5 ml jew 100 mg ta' paclitaxel f'16.7 ml jew 150 mg ta' paclitaxel f'25 ml jew 300 mg ta' paclitaxel f'50 ml).
English: Use by::
Maltese: Tel.:
English: The incidence of Grade 4 neutropenia lasting 7 days or more was 22 %.
Maltese: L-inċidenza ta' newtropenija ta' Grad 4 li ddum 7ijiem jew aktar kienet ta' 22 %.
English: Excipients
Maltese: Opava
English: Response rates strongly favoured the paclitaxel-containing arms [13 %, 30 % and 26 % for the etoposide/cisplatin, high-dose paclitaxel (p< 0.001 vs etoposide/cisplatin) and low-dose paclitaxel regimens (p= 0.003 vs etoposide/cisplatin), respectively].
Maltese: 001 vs etoposidecisplatin) u doża baxxa ta' reġimeni b'paclitaxel (p=0.003 vs etoposide/cisplatin) rispettivament].
English: Paclitaxel at low doses of 0.6 mg/kg/day was associated with low fertility and foetal toxicity in rats.
Maltese: Paclitaxel f'dożi baxxi ta' 0.6 mg/kg/jum kien assoċjat ma' fertilità baxxa u tossiċità fil-fetu fil-firien.
English: • Problems with your lungs including swelling and fluid accumulation, which may cause breathing problems
Maltese: • Problemi fil-pulmun tiegħek li jinkludu nefħa u akkumulazzjoni tal-fluwidu, li jista' jikkawża problemi tan-nifs.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 300 mg/50 ml
Maltese: U KONTENUT Konċentrat għal soluzzjoni għall-infużjoni 300 mg/50 ml
English: Rare*: motor neuropathy (with resultant minor distal
Maltese: Rari*: newropatija motorili (b'riżultat ta dgħufija minuri filparti distali)
English: Pseudomembranous colitis has been rarely reported including cases in patients who have not been concomitantly treated with antibiotics.
Maltese: Kolite psewdomembranuża ġiet rapportata b'mod rari inkluż f'każijiet meta pazjenti ma ġewx trattati konġuntivament b'antibijotiċi wkoll.
English: The table below lists undesirable effects associated with the administration of single agent paclitaxel as a 3 hour infusion in the metastatic setting (286 patients treated in Paxene clinical studies and 812 patients treated in other paclitaxel clinical studies), and those reported in the postmarketing surveillance of paclitaxel*.
Maltese: It-tabella ta' hawn isfel turi l-effetti mhux mixtieqa assoċjati ma' paclitaxel meta ngħata waħdu f'infużjoni ta' 3 sigħat f'ambjent metastatiku (286 pazjent ikkurat fl-istudji kliniċi b'Paxene u 812-il pazjent kkurat fi studji kliniċi oħrajn b'paclitaxel), u dawk rapportati fis-sorveljanza ta' wara t-tqegħid ta' paclitaxel* fis-suq.
English: In order to minimise patient exposure to the plasticiser DEHP [di-(2-ethylhexyl)phthalate], which may be leached from PVC infusion bags or sets, diluted Paxene solutions should be stored in bottles (glass, polypropylene) or plastic bags (polypropylene, polyolefin) and administered through polyethylene-lined administration sets.
Maltese: Sabiex titnaqqas lespożizzjoni tal-pazjent għal plastiċizzur DEHP [di-(2-ethylhexyl)phthalate], li jista' jilissa mill-boroż ta' infużjoni ta' PVC, soluzzjonijiet ta' Paxene dilwit għandu jiġi maħżun fi fliexken (ħġieġ, polypropylene) jew boroż tal-plastik (polypropylene, polyolefin) u mogħtija minn settijiet b'inforra tal-polyethylene.
English: Paxene should only be administered under the supervision of a qualified oncologist in units specialised in the administration of cytotoxic agents (see section 6.6).
Maltese: Paxene għandu jingħata biss taħt is-superviżjoni ta' onkoloġista kwalifikat f'taqsimiet speċjalizzati fl-għoti ta' sustanzi ċitotossiċi (ara sezzjoni 6.6)
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 30 mg/5 ml
Maltese: U KONTENUT Konċentrat għal soluzzjoni għall-infużjoni 30 mg/5ml
English: The active substance is paclitaxel 6 mg/ml (30 mg/5 ml, 100 mg/16.7 ml, 150 mg/25 ml or 300 mg/50 ml).
Maltese: Is-sustanza attiva hi paclitaxel 6 mg/ml(30 mg/5 ml, 100 mg/16.
English: HOW TO STORE PAXENE
Maltese: Tieħux Paxene
English: Neuropathy occurred in 18 % of patients treated with Paxene.
Maltese: In-newropatija seħħet fi 18 % tal-pazjenti kkurati b'Paxene.
English: • Fits (convulsions, seizures)
Maltese: • Attakki tal-qamar (konvulżjonijiet, attakki ta' puplesija)
English: Common: transient skin change, dry skin, exfoliative dermatitis, pruritis, rash, acne, transient and mild nail
Maltese: Komuni: bdil għaddieni fil-ġilda, ġilda xotta, dermatite eksfoljattiva, dermatite, ħakk, raxx, akne, bdil ħafif fid-dwiefer li jgħaddi
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 6 mg/ml of paclitaxel (100 mg of paclitaxel in 16.7 ml)
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kunjett wieħed fih 6 mg/ml paclitaxel (100 mg ta' paclitaxel f'16.7 ml)
English: The clinical response rate was 18.5 %, median time to progression was 2.8 months (CI: 2.1 - 3.3 months) and the median survival time was 9.9 months (CI: 7.8 - 13.1 months).
Maltese: Ir-rata ta' rispons kliniku kienet ta' 18.5 %, iż-żmien medjan ta' firxa kienet ta' 2.8 xhur (CI: 2.1 - 3.3 xhur) u ż-żmien medjan ta' sopravivenza kienet ta' 9.9 xhur (CI: 7.8 - 13.1 xhur).
English: However, the higher response rates (37 % vs. 26 %), lesser overall side effects and improved short term QoL with cisplatin/paclitaxel vs cisplatin/tenoposide were considered important results in a palliative population.
Maltese: Madankollu, ir-rati ta' rispons ogħla (37 % vs 26 %), il-fatt li kien hemm inqas effetti sekondarji u t-titjieb fit-terminu qasir fil-kwalità talħajja b'cisplatin/paclitaxel vs cisplatin/tenoposide kienu kkonsidrati riżultati importanti f'popolazzjoni paljattiva.
English: • Eating disorders including anorexia
Maltese: • Disturbi marbuta mat-teħid ta' ikel li jinkludu anoreksja
English: AIDS-related Kaposi's sarcoma, the maximum concentrations ranged from 761 to 2,860 ng/ml (mean 1,530) and average area under the plasma concentration vs. time curve (AUC) was 5,619 ng/h/ml (range 2,609 - 9,428).
Maltese: Wara li ngħatat doża ġol-vina ta'100 mg/m2 b'infużjoni ta' 3 sigħat lil 19-il pazjent li jbatu minn sarkoma ta' Kaposi relatata mal-AIDS, il-konċentrazzjonijiet massimi varjaw minn 761 sa 2,860 ng/ml (medja 1,530) u l-erja medja taħt il-konċentrazzjoni tal-plażma kontra l-kurva tal-ħin (AUC) kienet ta' 5,619 ng/h/ml (medda ta' bejn 2,609 - 9,428).
English: Pharmacokinetic parameters of paclitaxel at 175 mg/m2 given over 3 hours in 5 patients with breast cancer and 3 patients with ovarian cancer were as follows: maximum concentration (Cmax) was 4,213 ng/ml, area under the plasma concentration vs. time curve (AUClast) was 12,603 ng·h/ml and clearance (CL) was 20.4 l/h/m2.
Maltese: Parametri farmakokinetiċi ta' paclitaxel f'doża ta' 175 mg/m2 mogħtija fuq perijodu ta' tliet sigħat f'5 pazjenti bil-kanċer tas-sider u 3 pazjenti bil-kanċer ovarjan kienu kif ġej: konċentrazzjoni massima (Cmax) kienet ta' 4,213 ng/ml, erja taħt il-kurva ta' konċentrazzjoni fil-plażma kontra ħin (AUClast) kienet ta' 12,603 ng·h/ml u rata ta' tneħħija kienet ta' 20.
English: When paclitaxel was given after cisplatin, patients showed a more profound myelosuppression and an approximately 20 % decrease in paclitaxel clearance.
Maltese: Meta paclitaxel ingħata wara cisplatin, ilpazjenti wrew majelosuppressjoni aktar profonda u kellhom tnaqqis ta' madwar 20 % fir-rata taleliminazzjoni ta' paclitaxel.
English: Common: dyspnoea, epistaxis
Maltese: Komuni: disurja
English: Uncommon: (delayed) hypersensitivity, significant hypersensitivity reactions requiring therapy (e.g., hypotension, angioneurotic oedema, respiratory distress, generalised urticaria)
Maltese: Mhux komuni: reazzjonijiet ta' sensittività eċċessiva (mdewma), reazzjonijiet ta sensittività eċċessiva sinifikanti li jinħtieġu l-kura (eż., pressjoni baxxa, edema anġjonewrotika, disturb respiratorju, urtikarja ġeneralizzata)
English: Paclitaxel causes bone marrow suppression (particularly neutropenia).
Maltese: Paclitaxel jikkaġuna trażżin fil-mudullun (b'mod partikolari newtropenija).
English: It is generally believed that paclitaxel promotes the assembly of microtubules from tubulin dimer and prevents depolymerisation.
Maltese: Huwa ġeneralment emnut li paclitaxel iqanqal il-muntaġġ ta' mikrotubi mid-dimer ta' tubulin u jimpedixxi depolimerizzazzjoni.
English: Tel: + 33 1 41 11 28 50
Maltese: Mayne Pharma (France) SAS Tel: + 33 1 41 11 28 50
English: This medicine contains approximately 50 % by volume of alcohol.
Maltese: Din il-mediċina fiha madwar 50 % bil-volum ta' alkoħol.
English: Pharmacokinetic parameters of paclitaxel at 175 mg/m2 given over 3 hours in 13 patients with breast cancer were as follows: maximum concentration (Cmax) was 3,890 ng/ml, area under the plasma concentration vs. time curve (AUClast) was 14,090 ng/h/ml and clearance (CL) was 13.3 l/h/m2.
Maltese: 13-il pazjent b'kanċer tas-sider kienu kif ġej: konċentrazzjoni massima (Cmax) kienet ta' 3,890 ng/ml, erja taħt il-kurva ta' konċentrazzjoni ta' plażma kontra ħin (AUClast) kienet ta' 14,090 ng/h/ml u rata ta' tneħħija (CL) kienet ta' 13.3 l/h/m2.
English: An in-line filter with a microporous membrane not greater than 0.22 µm should be attached to the intravenous tubing during infusion of Paxene (see section 6.6).
Maltese: Filter ġol-pajp b'rita mikroporusa li mhix akbar minn 0.22 µm għandha titwaħħal mal-pajp ġol-vina matul l-infużjoni ta' Paxene (ara sezzjoni 6.6).
English: The usual dose of Paxene is 175 mg/m2 of body surface area.
Maltese: Ġeneralment, id-doża ta' Paxene hija ta' 175 mg/m2 tal-erja superfiċjali tal-ġisem.
English: The second major trial evaluated a maximum of 6 courses of either paclitaxel (135 mg/m² over 24 hours) followed by cisplatin (75 mg/m²) or control in over 400 patients with stage III/IV primary ovarian cancer, with a > 1 cm residual disease after staging laparotomy, or with distant metastases.
Maltese: Fit-tieni prova klinika ewlenija saret evalwazzjoni massima ta' 6 korsijiet jew ta' paclitaxel (135 mg/m² fuq 24 siegħa) segwit minn cisplatin (75mg/m²) jew kontroll f'aktar minn 400 pazjent li kienu jinsabu fl-istadju III/IV tal-kanċer tal-ovarju, b'> 1 ċm ta' fdal marradi wara l-laparotomija jew b'metastasi mbegħda.
English: • Itching, red skin rash
Maltese: • Ħakk, raxx aħmar fuq ġilda
English: 19 % of patients had severe neutropenia for > 7 days.
Maltese: 19 % tal-pazjenti kellhom newtropenija severa għal > 7 ijiem.
English: In this leaflet:
Maltese: Uża sa:
English: The frequency of possible side-effects listed below is defined using the following convention: very common (affects more than 1 person in 10) common (affects 1 to 10 persons in 100) uncommon (affects 1 to 10 persons in 1,000)
Maltese: Il-frekwenza ta' effetti kollaterali possibbli huma elenkati hawn isfel u huma mfissra skont ilkonvenzjoni li ġejja: komuni ħafna (jaffettwa aktar minn persuna f'10) komuni (jaffettwa minn 1 sa 10 persuni f'100) mhux komuni (jaffettwa minn 1 sa 10 persuni f'1,000) rari (jaffettwa minn 1 sa 10 persuni f'10,000) rari ħafna (jaffettwa anqas minn persuna waħda f'10,000) mhux magħruf (il-frekwenza ma tistax tiġi stmata mit-tagħrif disponibbli
English: Two doses of Paxene may be given: Paxene 175 mg/m2 of body surface area administrated as a 3 hour infusion into a vein, followed by another medicine, cisplatin, every three weeks; alternatively Paxene 135 mg/m2 given as a 24 hour infusion, followed by cisplatin, every three weeks.
Maltese: Paxene 175 mg/m2 tal-erja superfiċjali tal-ġisem mogħti bħala infużjoni ta' 3 sigħat ġol-vina, segwit minn mediċina oħra msejħa cisplatin kull tliet ġimgħat; inkella Paxene 135 mg/m2 mogħti bħala infużjoni fuq 24 siegħa, segwit minn cisplatin, kull tliet ġimgħat.
English: The major elimination pathway is metabolism followed by biliary excretion; in six patients 39 % to 87 % of an intravenous dose (175 mg/m2) was excreted in faeces and, on average, only 10 % of the dose was excreted as unchanged paclitaxel.
Maltese: Il-metaboliżmu huwa l-mezz ewlieni segwit b'eliminazzjoni mill-bili tal-marrara; f'sitt pazjenti 39 % sa 87 % tad-doża mogħtija ġol-vina (175 mg/m2) ġiet eliminata fl-ipurgar u, fuq medja, 10 % biss tad-doża ta' paclitaxel baqgħet l-istess.
English: In the rare event of serious conduction abnormalities or arrhythmias, appropriate therapy and continuous cardiac monitoring is recommended during subsequent cycles of therapy.
Maltese: Fis-sitwazzjoni rari ta' abnormalitajiet serji fit-trasmissjoni jew arritmiji, għandha tingħata terapija xierqa u monitoraġġ kardijaku kontinwu huwa rakkomandat waqt ċikli sussegwenti ta' terapija.
English: Common side-effects are listed below:
Maltese: Effetti sekondarji komuni huma elenkati isfel:
English: Common: severe neuropathy (mainly peripheral), dizziness, nervousness, insomnia, depression, abnormal thinking, hypokinesia, abnormal gait, hypaesthesia, taste perversion,
Maltese: Komuni: newropatija severa (prinċipalment periferali), sturdament, nervi, nuqqas ta' rqad, depressjoni, ħsibijiet mhux normali, ipokinesja, pass mhux normali, ipestesja, bidla fit-togħma, uġigħ ta' ras.
English: The terminal elimination half-life averaged 23.7 hours
Maltese: Il-half-life terminali għall-eliminazzjoni kienet f'medja ta 23.7 sigħat (medda 12-33).
English: 4.4 Special warnings and special precautions for use Patients must be routinely premedicated with a corticosteroid, an antihistamine, and an H2-receptor antagonist prior to Paxene to prevent severe hypersensitivity reactions (see section 4.2).
Maltese: Il-pazjenti għandhom jibdew jiġu kkurati regolarment b'kortikosterojd, antiistamin u antagonista ta' riċettur-H2 qabel ma' jingħata Paxene biex jiġi evitat li jkun hemm reazzjoni eċċessiva serja (ara sezzjoni 4.2).
English: Concurrent, serious, uncontrolled infections.
Maltese: Infezzjonijiet mhux ikkontrollati, serji fl-istess żmien.
English: Four pack sizes are available: 30 mg/5 ml vial, 100 mg/16.7 ml vial, 150 mg/25 ml vial and 300 mg/50 ml vial packaged in a carton.
Maltese: 7 ml, kunjett ta' 150 mg/25 ml u kunjett ta' 300 mg/50 ml ippakkettati f'kartuna.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON TEXT FOR PAXENE 100 mg/16.7 ml
Maltese: Ż-ŻGĦAR EWLENIN KITBA FUQ IL-KUNJETT TA' PAXENE 100 mg/16.7 ml
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON TEXT FOR PAXENE 300 mg/50 ml
Maltese: Ż-ŻGĦAR EWLENIN KITBA FUQ IL-FJALA GĦAL PAXENE 300 mg/50 ml
English: Advanced ovarian cancer (first-line therapy)
Maltese: Kanċer tal-ovarju avvanzat (kura preferuta)
English: The efficacy and safety of Paxene (175 mg/m² over 3 hours repeated at 3-week intervals) in advanced metastatic ovarian cancer were investigated in 120 women in a multicentre, open-label extended Phase II trial.
Maltese: L-effikaċja u s-sigurtà ta' Paxene (175 mg/m² fuq 3 sigħat ripetuti f'intervalli kull 3 ġimgħat) f'kanċer ovarjan fl-istat metastatiku avvanzat ġew investigati f'120 mara fi prova estiża ta' Fażi
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 6 mg/ml of paclitaxel (150 mg of paclitaxel in 25 ml)
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kunjett wieħed fih 6 mg/ml paclitaxel (150 mg ta' paclitaxel f'25 ml)
English: • Abnormal heart rhythm
Maltese: • Ritmu mhux normali tal-qalb
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 6 mg/ml of paclitaxel (30 mg of paclitaxel in 5 ml).
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kunjett wieħed fih 6 mg/ml paclitaxel (30 mg ta' paclitaxel f'5 ml)
English: In liposomal anthracycline-resistant patients, the response rates were comparable for patients who had never received a protease inhibitor (55.6 %) and those who received one at least 2 months prior to treatment with Paxene (60.9 %).
Maltese: F'pazjenti reżistenti għal anthracycline liposomali, ir-rati ta risponsi kienu paragunabbli ma dawk ta' pazjenti li qatt ma ħadu impeditur tal-protease (55.6 %) u dawk li rċevew tal-anqas wieħed fi żmien xahrejn qabel ma bdiet il-kura b'Paxene (60.9 %).
English: • Advanced ovarian cancer when certain other treatments (platinum-containing combination therapy without taxanes) have been tried but have not worked (as second-line treatment).
Maltese: • Kanċer tal-ovarju fl-istadju avvanzat meta mediċini speċifiċi oħrajn (terapija kombinata li fiha lplatinu mingħajr taxanes) ġew ippruvati imma ma ħadmux (bħala t-tieni kura preferuta).
English: Patients with severe hepatic impairment should not be treated with paclitaxel.
Maltese: Sintomi sensorjali ġeneralment marru għal aħjar jew irrisolvew rwieħom xhur wara li twaqqaf paclitaxel.