qanastek/EMEA-V3 huggingface dataset:
For use of cisplatin in treatment of advanced ovarian carcinoma and non-small cell lung carcinoma, please consult the Summary of Product Characteristics of Cisplatin for information.
Għal użu ma ’ cisplatin fil- kura ta 'karsinoma ta ’ l- ovarju avvanzata u f' karsinoma non small cell lung jekk jogħġbok ikkonsulta l- Karatteristiċi tal- Prodott fil- Qosor għal aktar tagħrif.
2 AIDS-related Kaposi’ s sarcoma:
Sarkoma ta ’ Kaposi relatata ma ’ AIDS:
The recommended dose of Paxene is 100 mg/ m2 administered as a 3 hour intravenous infusion every two weeks.
Id- doża rakkomandata ta ’ Paxene hija ta ’ 100 mg/ m2 mogħtija bħala infużjoni ta ’ 3 sigħat ġol- vina kull ġimagħtejn.
Metastatic breast and ovarian cancer (second-line treatment):
Kanċer tas- sider fi stat metastatiku u kanċer ta ’ l- ovarju fi stat metastatiku (bħala t- tieni kura preferuta):
The recommended dose of Paxene is 175 mg/ m2 administered as a 3 hour intravenous infusion every three weeks.
Id- doża rakkomandata ta ’ Paxene hija ta ’ 175 mg/ m2 mogħtija bħala infużjoni ta ’ 3 sigħat ġol- vina kull tlett ġimgħat.
Advanced ovarian carcinoma (first-line treatment):
Kanċer ta ’ l- ovarju avvanzat (kura preferuta):
Although other dosage regimens/ combinations are under investigation, a combination regimen of Paxene and cisplatin is recommended.
Għalkemm dożaġġi b’ reġimeni/ kombinazzjonijiet oħra qed jiġu mistħarrġa, huwa rakkomandat li jintuża reġimen ikkombinat b’ Paxene u cisplatin.
According to the duration of infusion, two dosage regimes of Paxene are recommended:
Skond kemm iddum l- infużjoni, żewġ reġimi ta ’ dożi b’ Paxene huma rakkomandati:
Paxene 175 mg/ m2 administered as a 3 hour intravenous infusion, followed by cisplatin 75 mg/ m2 every three weeks or Paxene 135 mg/ m2 as a 24 hour infusion, followed by cisplatin 75 mg/ m2 every three weeks.
Paxene 175 mg / m2 mogħti bħala infużjoni ta ’ 3 sigħat, sussegwit b’ cisplatin 75 mg/ m2 kull tlett ġimgħat jew Paxene 135 mg/ m2 bħala infużjoni ta ’ 24 siegħa, sussegwit b’ cisplatin 75 mg/ m2 kull tlett ġimgħat.
The recommended dose of Paxene is 175 mg/ m2 administered as a 3 hour intravenous infusion, followed by cisplatin at a dose of 80 mg/ m2 every three weeks.
Karsinoma non- small cell lung avvanzata Id- doża rakkomandata ta ’ Paxene hi ta ’ 175/ mg/ m2 mogħtija bħala infużjoni ta ’ tlett sigħat sussegwita b’ cisplatin f’ doża ta ’ 80 mg/ m2 kull tlett ġimgħat.
Dosage adjustments during treatment
Aġġustamenti tad- doża waqt il- kura
Metastatic breast carcinoma, ovarian cancer and non-small cell lung carcinoma:
Karsinoma tas- sider fi- istat metastatiku u kanċer ta ’ l- ovarju u karsinoma non- small cell lung:
Courses of Paxene should not be repeated until the neutrophil count is at least 1,500 cells/ mm3 and the platelet count is at least 100,000 cells/ mm3.
Korsijiet ta ’ Paxene m’ għandhomx jiġu ripetuti qabel ma l- għadd ta ’ newtrofili jkun ta ’ l- anqas 1, 500 ċelluli/ mm3 u l- għadd ta ’ plejtlets jkun ta ’ l- anqas 100, 000 ċellula/ mm3.
Patients who experience severe neutropenia (neutrophils < 500 cells/ mm3 for a week or longer) or severe peripheral neuropathy during Paxene therapy should have their dosage reduced by 20% (NSCLC and first-line treatment of ovarian cancer) or 25% (MBC and MOC) for subsequent courses of Paxene.
Pażjenti li jkollhom newtropenija serja (newtrofili < 500 ċellula/ mm3 għal ġimgħa jew aktar) jew newropatija periferali serja waqt terapija b’ Paxene għandu jkollhom id- doża mnaqqsa għal 20% (NSCLC u l- kura preferuta għal kanċer ta ’ l- ovarju jew 25% (MBC u MOC) għal korsijiet sussegwenti ta ’ Paxene.
Patients who experience mucositis (Grade 2 or worse) during Paxene therapy should have their dosage reduced by 25% for subsequent courses of Paxene.
Pazjenti li jkollhom mukosite (Grad 2 jew agħar) waqt it- terapija b’ Paxene għandu jkollhom id- doża mnaqqsa b’ 25% għal korsijiet sussegwenti ta ’ Paxene.
Courses of Paxene should not be repeated until the neutrophil count is at least 1,000 cells/ mm3 and the platelet count is at least 75,000 cells/ mm3.
Sarkoma ta ’ Kaposi relatata ma ’ l- AIDS Korsijiet ta ’ Paxene m’ għandomx jiġu ripetuti kemm- il darba l- għadd ta ’ newtrofili jkun ta ’ l- anqas, 1, 000 ċellula/ mm3 u l- għadd ta ’ plejtlets huwa ta ’ l- anqas 3
Patients who experience severe neutropenia (neutrophils < 500 cells/ mm3 for a week or longer), severe peripheral neuropathy or mucositis (Grade 3 or worse) during Paxene therapy should have their dosage reduced by 25% to 75 mg/ m2 for subsequent courses of Paxene.
b’ newtropenija serja (< 500 ċellula/ mm newtrofili għal ġimgħa jew aktar), newropatija periferika serja jew mukosite (Grad 3 jew agħar) waqt terapija b’ Paxene għandu jkollhom d- doża mnaqqsa b’ 25% sa 75 mg/ m2 għal korsijiet sussegwenti ta ’ Paxene.
Patients with impaired hepatic function:
Pazjenti li għandhom il- funzjoni tal- fwied indebolita:
Adequate data are not available to recommend dosage alterations in patients with mild to moderate hepatic impairment (see 4.4 and 5.2).
M’ hemmx tagħrif disponibbli biżżejjed biex jirrakkomanda bidliet fid- dożaġġ f’ pazjenti li għandhom indeboliment minn ħafif sa moderat fil- funzjoni tal- fwied (ara 4. 4 u 5. 2).
Patients with severe hepatic dysfunction should not be treated with paclitaxel.
Pazjenti li għandhom tnaqqis serju fil- funzjoni tal- fwied m’ għandhomx jiġu kkurati b’ paclitaxel.
Studies in patients with impaired renal function have not been performed and there are insufficient data to permit dosage recommendations (see 5.2).
Ma twettqux studji fuq pazjenti li għandhom indeboliment fil- funzjoni tal- kliewi u m’ hemmx biżżejjed tagħrif li jippermetti li jkun hemm rakkomandazzjonijiet fuq id- doża (ara 5. 2).
Paediatric use:
3 Użu fit- tfal:
Safety and efficacy in children (under 18 years) has not been established.
Is- sigurtà u l- effikaċja fit- tfal (taħt 18- il sena) ma ġewx stabbiliti.
Therefore, paclitaxel is not recommended for paediatric use.
Għalhekk, paclitaxel m’ hux rakkomandat għal użu fit- tfal.
History of severe hypersensitivity reaction to paclitaxel or polyethoxylated castor oil.
Storja medika ta ’ reazzjoni eċċessiva serja għal paclitaxel jew polyethoxylated castor oil.
Severe hepatic impairment.
Indeboliment epatiku serju.
3 Baseline neutrophil count < 1,500 cells/ mm3 (< 1,000 cells/ mm3 for AIDS-KS).
Għadd ta ’ newtrofili < 1, 500 ċellula / mm3 (< 1, 000 ċellula/ mm3 għal pazjenti b’ AIDS- KS).
Concurrent, serious, uncontrolled infections.
Infezzjonijiet mhux ikkontrollati, serji konkurrenti.
Pregnancy and lactation.
Tqala u treddigħ.
Paxene contains polyethoxylated castor oil, which can cause an allergic reaction.
Paxene fih polyoxylated castor oil, li jista ’ jikkaġuna reazzjoni allerġika.
Paxene should be given before cisplatin when used in combination (see 4.5).
Il- pazjenti għandhom jibdew jiġu kkurati regolarment b’ kortikosterojd, anti- istamin u antagonista ta ’ riċettur- H2 qabel ma ’ jingħata Paxene biex jiġi evitat li jkun hemm reazzjoni eċċessiva serja (ara 4. 2).
Hypersensitivity reactions
Paxene għandu jingħata qabel cisplatin meta dawn jintużaw flimkien (ara 4. 5).
Minor symptoms such as flushing or skin reactions do not require interruption of therapy.
Reazzjonijiet ta ’ sensittività eċċessiva Sintomi żgħar bħal fwawar jew reazzjonijiet fuq il- ġilda m’ għandhomx iwaqqfu t- terapija.
However, severe reactions, such as hypotension requiring treatment, dyspnoea requiring bronchodilators, angio- oedema or generalised urticaria require immediate discontinuation of paclitaxel and aggressive symptomatic therapy.
Madankollu, f’ każijiet ta ’ reazzjoni serja, bħal pressjoni baxxa li tinħtieġ kura, dispneja li tinħtieġ wessiegħa tal- bronki, anġjodema jew urtikarja ġeneralizzata jkun hemm bżonn li paclitaxel jitwaqqaf minnufih u tingħata terapija aggressiva ta ’ appoġġ.
Patients experiencing severe reactions should not be rechallenged with the product.
Pazjenti li jkunu għaddew minn reazzjonijiet serji m’ għandhomx jingħataw il- prodott mill- ġdid.
Patients should be observed closely during the initial cycles of treatment.
Il- pazjenti għandhom jiġu osservati b’ attenzjoni waqt iċ- ċikli inizjali ta ’ trattament.
Appropriate supportive therapies should be readily available in case of a severe hypersensitivity reaction.
Terapiji ta ’ appoġġ adattati għandhom ikunu disponibbli faċilment f’ każ ta ’ reazzjoni ta ’ sensittività eċċessiva.
Paclitaxel causes bone marrow suppression (particularly neutropenia).
Ematoloġija Paclitaxel jikkaġuna trażżin fil- mudullun (b’ mod partikolari newtropenija).
Therefore, frequent complete blood counts should be performed on all patients during treatment.
Għalhekk, waqt il- kura kull pazjent għandu jittieħidlu l- għadd sħiħ ta ’ ċelluli ta ’ demm b’ mod regolari.
Patients with baseline neutrophil counts < 1,500 cells/ mm3 (< 1,000 cells/ mm3 for AIDS-KS) should not receive paclitaxel.
Pazjenti li għandhom l- għadd ta ’ newtrofili bħala referenza bażi < 1, 500 ċellula/ mm3 (< 1, 000 ċellula/ mm3 għal pazjenti b’ AIDS- KS) m’ għandhomx jieħdu paclitaxel.
Patients should not be re-treated with subsequent cycles of paclitaxel until neutrophil counts recover to ≥ 1,500 cells/ mm3 (≥ 1,000 cells/ mm3 for AIDS-KS patients) and platelets recover to a level of ≥ 100,000 cells/ mm3 (≥ 75,000 cells/ mm3 for AIDS-KS patients).
Pazjenti m’ għandhomx jiġu kkurati mill- ġdid b’ ċikli sussegwenti ta ’ paclitaxel sakemm l- għadd ta ’ newtrofili jirkupra għal livell ta ’ ≥1, 500 ċellula/ mm3 (≥1, 000 ċellula/ mm3 għal pazjenti b’ KS- AIDS) u l- plejtlets jirkupraw għal livell ta ’ ≥100, 000 ċellula/ mm3 (≥75, 000 ċellula/ mm3 għal pazjenti b’ AIDS- KS).
Patients with severe neutropenia (< 500 cells/ mm3 for 7 days or more) during a course of paclitaxel or neutropenic sepsis should have their dose of paclitaxel reduced for subsequent courses of Paxene therapy (see 4.2).
Pazjenti li għandhom newtropenja serja (< 500 ċellula/ mm3 għal 7 ijiem jew aktar) waqt kors ta ’ paclitaxel jew sepsis newtropeniku għandu jkollhom id- doża tagħhom ta ’ paclitaxel mnaqqsa għal korsijiet sussegwenti ta ’ terapija ta ’ Paxene (ara 4. 2)
Moderate to severe mucositis is uncommon with the recommended dose and schedule of Paxene.
Mukosite Mukosite minn moderata għal serja mhix komuni bid- doża rakkomandata u skedata ta ’ Paxene.
However, if treatment is to be continued in the event of moderate or severe reactions, the dose of paclitaxel should be reduced for subsequent courses of Paxene (see 4.2).
Madankollu, jekk il- kura għandha titkompla fil- każ ta ’ reazzjonijiet minn moderati sa serji, id- doża ta ’ paclitaxel għandha tiġi mnaqqsa f’ korsijiet sussegwenti ta ’ Paxene (ara 4. 2).
Neuropathy, primarily peripheral sensory neuropathy, occurs very commonly and is usually of mild to moderate intensity.
Newropatija Newropatija, prinċipalment newropatija sensorjali periferika sseħħ b’ mod komuni ħafna u ġeneralment tkun ta ’ intensità minn ħafifa sa moderata.
Severe peripheral neuropathy occurred in 3% of patients treated with the recommended dose and schedule of Paxene.
Newropatija periferika serja seħħet fi 3% tal - pazjenti kkurati bid- doża rakkomandata u skedata ta ’ Paxene.
In the treatment of NSCLC and the first-line treatment of ovarian cancer, the administration of paclitaxel as a 3 hour infusion in combination with cisplatin resulted in a greater incidence of severe neurotoxicity than both single-agent paclitaxel and cyclophosphamide followed by cisplatin.
4 ppreferuta fil- kanċer ta ’ l- ovarju, l- għoti ta ’ paclitaxel bħala infużjoni ta ’ 3 sigħat flimkien ma ’ cisplatin irriżulta f’ inċidenza ogħla ta ’ newrotossiċità serja aktar milli kieku ttieħed paclitaxel u cyclophosphamide bħala mediċina weħida segwita minn cisplatin.
If severe peripheral neuropathy occurs the benefit of continued treatment should be weighed against the risks.
Jekk ikun hemm newropatija periferika serja, il- benefiċċju li jista ’ joħroġ bl- issoktar tal- kura għandu jiġi mwieżen kontra r- riskji.
However, if treatment is to be continued, the dose of paclitaxel should be reduced for all subsequent courses of Paxene (see 4.2).
Madankollu, jekk il- kura għandha tissokta d- doża ta ’ paclitaxel għandha titnaqqas f’ kull kors sussegwenti ta ’ Paxene (ara 4. 2).
In patients treated with paclitaxel severe conduction abnormalities are rare.
Anormalitajiet fit- trasmissjoni kardijaka u aritmiji F’ pazjenti kkurati b’ paclitaxel anormalitajiet fit- trasmissjoni huma rari.
Mild electrocardiogram changes have been observed during administration of paclitaxel.
Bidliet ħfief fl - elettrokardjogramma ġew osservati waqt l- għoti ta ’ paclitaxel.
Cardiac monitoring is not recommended except in patients with serious conduction abnormalities or arrhythmias.
Monitoraġġ kardijaku mhux rakkomandat ħlief f’ pazjenti li għandhom abnormalitajiet serji fit- trasmissjoni jew aritimi.
In the rare event of serious conduction abnormalities or arrhythmias, appropriate therapy and continuous cardiac monitoring is recommended during subsequent cycles of therapy.
Fis - sitwazzjoni rari ta ’ abnormalitajiet serji fit- trasmissjoni jew arritimi, għandha tingħata terapija xierqa u monitoraġġ kardijaku kontinwu huwa rakkomandat waqt ċikli sussegwenti ta ’ terapija.
Hypotension, hypertension and bradycardia have been observed during administration of paclitaxel but patients are usually asymptomatic and do not require therapy.
Waqt l- għoti ta ’ paclitaxel ġew osservati l- kundizzjonijiet ta ’ pressjoni baxxa fid- demm, pressjoni għolja u bradikardja iżda l- pazjenti ġeneralment ikunu asimptomatiċi u ma jkunx hemm bżonn ta ’ terapija.
Additionally, in Paxene MBC and MOC studies tachycardia, palpitation and syncopes were observed.
Barra minn hekk, fi studji b’ MBC u MOC b’ Paxene ġew osservati li kien hemm takikardja, palpitazzjoni u sinkope.
Therefore, frequent monitoring of vital signs during the first hours of Paxene infusion is recommended.
Għalhekk monitoraġġ ta ’ spiss ta ’ sinjali vitali fl- ewwel siegħat ta ’ infużjoni ta ’ Paxene huwa rakkomandat.
In the MBC and MOC studies a total of two patients experienced Grade 4 congestive heart failure.
Fl- istudji ta ’ MBC u MOC żewġ pazjenti kellhom insuffiċjenza tal- qalb konġestiva ta ’ Grad 4.
A single case of heart failure related to Paxene was seen in the AIDS-KS clinical study.
Kien hemm każ wieħed ta ’ insuffiċjenza tal- qalb b’ Paxene fl- istudju kliniku ta ’ AIDS- KS
Severe cardiovascular events were observed more frequently in patients with NSCLC than breast or ovarian carcinoma.
Każijiet kardjovaskulari serji ġew osservati bi frekwenza akbar f’ pazjenti li għandhom NSCLC milli f’ pazjenti b’ karsinoma tas- sider jew ta ’ l- ovarju.
Hepatic impairment
Indeboliment fil- funzjoni tal- fwied
Patients with hepatic impairment may be at increased risk of toxicity, particularly Grade 3-4 myelosuppression.
Pazjenti b’ indeboliment fil- funzjoni tal- fwied jistgħu jkunu f’ riskju ogħla ta ’ tossiċità, partikolarment trażżin tal- mudullun ta ’ Grad 3- 4.
There is no evidence that the toxicity of paclitaxel is increased when given as a 3 hour infusion to patients with mildly abnormal liver function.
M’ hemm l- ebda evidenza li t- tossiċità ta ’ paclitaxel tiżdied meta mogħti bħala infużjoni ta ’ 3 sigħat lil pazjenti li għandhom funzjoni tal- fwied li hi moderatament anormali.
When given as a longer infusion, increased myelosuppression may be seen in patients with moderate to severe hepatic impairment.
Meta mogħti bħala infużjoni itwal, żjieda fit- trażżin tal- mudullun tista ’ tidher f’ pazjenti li għandhom indeboliment minn moderat sa serju fil- funzjoni tal- fwied.
Patients should be closely monitored for the development of profound myelosuppression (see 4.2).
Il- pazjenti għandhom ikunu osservati mill- qrib għall- iżvilupp ta ’ trażżin tal- mudullun profond (ara 4. 2).
Adequate data are not available to recommend dosage alterations in patients with mild to moderate hepatic impairments (see 5.2).
M’ hemmx tagħrif disponibbli biżżejjed biex jirrakkomanda bidliet fid- dożaġġ f’ pazjenti li għandhom indeboliment minn ħafif sa moderat fil- funzjoni tal- fwied (ara 5. 2).
No data are available for patients with severe baseline cholestasis.
L- ebda tagħrif m’ hu disponibbli dwar pazjenti b’ linja ta ’ riferiment għall- kolestasi serja.
Patients with severe hepatic impairment should not be treated with paclitaxel.
Il- pazjenti b’ indeboliment tal- fwied serju m’ għandhomx jiġu ttrattati bil- paclitaxel.
Gastrointestinal
Gastrointestinali
Pseudomembranous colitis has been rarely reported including cases in patients who have not been concomitantly treated with antibiotics.
Kolite psewdomembranuża ġiet rapportata b’ mod rari inkluż f’ każijiet meta pazjenti ma ġewx trattati konġuntivament b’ antibijotiċi wkoll.
This reaction should be considered in the differential diagnosis of cases of severe or persistent diarrhoea occurring during or shortly after treatment with paclitaxel.
Din ir- reazzjoni għandha tiġi kkonsidrata fid- dijanjosi differenzjali ta ’ każijiet ta’ dijarrea serja jew persistenti li sseħħ waqt jew ftit wara trattament b’ paclitaxel.
As Paxene contains ethanol (392 mg/ ml), possible effects on the CNS and other effects should be considered (see 4.7).
Effetti possibbli fuq is- Sistema Nervuża Ċentrali u effetti oħrajn għnandhom jiġu kkonsidrati billi Paxene fih l- ethanol (392 mg/ ml).
Paclitaxel, particularly in combination with radiation of the lung and/ or gemcitabine, irrespective of their chronological order, may contribute to the development of interstitial pneumonitis.
Paclitaxel, b’ mod partikolari meta jkun ikkombinat mar- radjazzjoni tal- pulmun u/ jew gemcitabine, irrespetivament mill- ordni kronoloġika, jista ’ jikkontribwixxi għall- iżvilupp ta ’ pnewmonite ta ’ l - interstizju.
Like other genotoxic cytostatics, paclitaxel can have genotoxic effects.
5 Bħal ċitostatiċi ġenotossiċi oħrajn, paclitaxel jista ’ jkollu effetti ġenotossiċi.
Male patients treated with Paxene are advised not to father a child during and up to six months after treatment.
Pazjenti rġiel trattati b’ Paxene huma rakkomandati li jevitaw kull rapport li jista ’ jwassal għat- twelid ta ’ tarbija matul u fis - sitt xhur ta ’ wara t- trattament.
Formal clinical drug interaction studies have not been performed with Paxene.
Studji formali ta ’ interazzjoni klinika fuq id- droga ma twettqux b’ Paxene.
When administered as part of a combination regimen with cisplatin, it is recommended that Paxene is given before cisplatin.
Meta mogħti bħala parti minn reġimen flimkien ma ’ cisplatin, huwa rakkomandat li Paxene jingħata qabel cisplatin.
When paclitaxel is given before cisplatin, the safety profile of paclitaxel is consistent with that reported for single-agent use.
Meta paclitaxel jingħata qabel cisplatin, il- profil tas- sigurtà ta ’ paclitaxel ikun konsistenti ma ’ dak rapportat meta tintuża mediċina waħda.
When paclitaxel was given after cisplatin, patients showed a more profound myelosuppression and an approximately 20% decrease in paclitaxel clearance.
Meta paclitaxel ingħata wara cisplatin, il - pazjenti wrew majelosuppressjoni aktar profonda u kellhom tnaqqis ta ’ madwar 20% fir- rata ta ’ l - eliminazzjoni ta ’ paclitaxel.
5 Since elimination of doxorubicin and its active metabolites may be reduced when paclitaxel and doxorubicin are used in combination, paclitaxel should be administered 24 hours after doxorubicin.
Peress li t- tneħħija ta 'doxorubicin u l- metaboliti attivi jistgħu jitnaqqsu meta' paclitaxel u doxorubicin jintużaw flimkien, Paclitaxel għandu jingħata 24 siegħa wara doxorubicin.
Since paclitaxel is metabolised by cytochrome P450 isoenzymes CYP 3A4 and 2C8, caution should be exercised with other drugs known to inhibit (e. g. erythromycin, fluoxetine, gemfibrozil, imidazole antifungals) or induce (e. g. rifampicin, carbamazepine, phenytoin, phenobarbital, efavirenz, nevirapine) these enzymes as they may affect the pharmacokinetics of paclitaxel.
Billi paclitaxel huwa metabolizzat b’ isoenzimi CYP 3A4 u 2C8 tas- cytochrome P450, attenzjoni għandha tingħata b’ mediċini oħrajn magħrufa li jimpedixxu (eż. erythromycin, fluoxetine, gemfibrozil, u antifungali ta ’ imidazole) jew li jissensittizzaw (eż. rifampicin, carbamazepine, phenytoin, phenobarbital, efavirenz, nevirapine) dawn l- enżimi billi jistgħu jaffetwaw l- farmakokineta ta ’ paclitaxel.
Concurrent administration of ketoconazole, a known potent inhibitor of CYP3A4, does not inhibit the elimination of paclitaxel in patients; thus, both medicinal products may be administered together without dosage adjustment.
L- għoti fl- istess ħin ta ’ ketoconazole, li hu inibitur potenti magħruf ta ’ CYP3A4, ma jimpedixxiex l- eliminazzjoni ta ’ paclitaxel fil- pazjenti; għalhekk, iż- żewġ prodotti mediċinali jistgħu jiġu mogħtija flimkien mingħajr aġġustament fid- dożagg.
Further data on the potential of drug interactions between paclitaxel and other CYP3A4 substrates/ inhibitors are limited.
Tagħrif addizzjonali dwar effetti oħrajn potenzjali tal- mediċina bejn paclitaxel u inibituri u sottostrati oħrajn ta ’ CYP3A4 huwa ristrett.
Studies conducted in AIDS-KS patients who were taking Paxene and multiple concomitant medications suggest that the systemic clearance of paclitaxel was significantly lower (p < 0.05) in the presence of nelfinavir and ritonavir, but not with indinavir.
Studji mwettqa f’ pazjenti li għandhom AIDS- KS li kienu qed jieħdu Paxene u mediċini diversi miegħu jindikaw li r- rata ta ’ eliminazzjoni sistematika ta ’ paclitaxel kienet sinifikament anqas (p < 0. 05) fil - preżenza ta ’ nelfinavir u ritonavir, imma mhux għal indinavir.
Insufficient information is available on interactions with other protease inhibitors.
M’ hemmx biżżejjed informazzjoni disponibbli fuq interazzjonijiet ma ’ impedituri ta ’ protease oħrajn.
Consequently, Paxene should be administered with caution in patients receiving protease inhibitors as concomitant therapy.
Sussegwentement, Paxene għandu jingħata b’ attenzjoni f’ pazjenti li qed jirċievu impedituri ta ’ protease bħala terapija konġunta.
Paclitaxel at an intravenous dose of 0.6 mg/ kg/ day produced reproductive and foetal developmental toxicity in rats.
Paclitaxel f’ doża ta ’ 0. 6 mg/ kg/ jum mogħtija ġol- vina kkaġunat tossiċità fl- iżvilupp tal- fetu u tossiċità riproduttiva fil- firien.
Paxene is contraindicated for use in pregnancy.
Paxene huwa kontra- indikat waqt it- tqala.
Women should be advised to use effective means of contraception to avoid becoming pregnant during therapy with Paxene and to inform the treating physician immediately should this occur.
Huma għandhom jinfurmaw minnufih lit- tabib li qed jikkurhom jekk jinqabdu tqal.
Paxene is contraindicated during lactation.
Paxene huwa kontra- indikat waqt l- irdigħ.
It is unknown whether paclitaxel is excreted in human milk.
Mhux magħruf jekk paclitaxel jiġix eliminat fil- ħalib tal - bniedem.
Therefore, breast-feeding should be discontinued for the duration of Paxene therapy.
Għalhekk, l- irdigħ għandu jitwaqqaf fil- perjodu ta ’ kemm iddum sejra t- terapija b’ Paxene.
Following an infusion of Paxene, the patients’ performance at skilled tasks (driving, operating machinery, etc.) may be impaired due to the alcohol content of Paxene (see 4.4 and 6.1).
Wara infużjoni f’ Paxene, il- ħila tal- pazjenti fuq xogħol (eż. sewqan, ħdim ta ’ makkinarju eċċ.) jista ’ jiġi mfixkel minħahha l- kontenut ta ’ alkoħol ta ’ Paxene (ara 4. 4 u 6. 1)
The following adverse reactions relate to 166 MBC and 120 MOC patients treated with 175 mg/ m2 Paxene administered as a 3 hour infusion as second-line chemotherapy in two clinical studies and were considered possibly or probably related to Paxene.
Ir- reazzjonijiet avversi li ġejjin jirrelataw għal 166 pazjent b’ MBC u 120 pazjent b’ MOC li kienu kkurati b’ 175 mg/ m2 Paxene mogħti bħala infużjoni ta ’ 3 sigħat bħala t- tieni kura kemoterapewtika ppreferuta, f’ żewġ studji kliniċi u kienu kkonsidrati li possibilment jew probabbilment huma relatati
As the AIDS-KS population is very specific, safety data from a clinical study of 107 AIDS-KS patients are presented separately at the end of Section 4.8.
Billi l- popolazzjoni ta ’ pazjenti b’ AIDS- SK hija speċifika ħafna, t- tagħrif ta ’ sigurtà minn studju kliniku ta ’ 107 pazjenti b’ AIDS- SK huwa ppreżentat separatament fl- aħħar ta ’ Sezzjoni 4. 8.
Bone marrow suppression was the major dose-limiting toxicity of Paxene.
L- aktar effett tossiku komuni ta ’ Paxene kien it- trażżin tal- mudllun ta ’ l- għadam.
Severe neutropenia (< 500 cells/ mm3) occurred in 26% of patients treated with Paxene during the entire treatment period.
Newtropenija serja (< 500 ċellula/ mm3) seħħet f’ 26% ta ’ pazjenti kkurati b’ Paxene matul il- perijodu kollu.
19% of patients had severe neutropenia for > 7 days.
19% tal- pazjenti kellhom newtropenija serja għal > 7 ijiem.
Thrombocytopenia was observed in 6% of patients.
Tromboċitopenija ġiet osservata f’ 6% tal- pazjenti.
Two percent of patients had a platelet count nadir < 50,000 cells/ mm3.
Tnejn fil- mija tal- pazjenti kellhom l- għadd ta plejtets l- aktar baxx f’ livell ta ’ < 50, 000 ċellula/ mm3.
Anaemia (Hb < 11 g/ dl) was observed in approximately 9% of treated patients but was severe in less than 1% (Hb < 8 g/ dl).
L- anemija (Hb < 11 g/ dl) ġiet osservata f’ madwar 9% tal- pazjenti kkurati imma kienet preżenti b’ mod serju f’ inqas minn 1% (Hb < 8 g/ dl).
Neuropathy occurred in 18% of patients treated with Paxene.
In- newropatija seħħet fi 18% tal- pazjenti kkurati b’ Paxene.
Paraesthesia was observed in 48% of patients.
Il- parasteżija ġiet osservata fi 48% tal - pazjenti.
Severe neuropathy and severe paraesthesia occurred in 3% and 5% of patients, respectively.
Newropatija serja u parasteżija serja seħħew fi 3% u 5% tal- pazjenti, rispettivament.
Peripheral neuropathy can occur following the first course and can worsen with increasing exposure to paclitaxel.
In - newtropatija periferali tista ’ isseħħ wara l- ewwel kors u tista ’ taggrava b’ esposizzjoni akbar għal paclitaxel.
Peripheral neuropathy was the cause of paclitaxel discontinuation in a few cases.
In- newtropatija periferika kienet il- kawża tal- waqfin ta ’ paclitaxel fi ftit każijiet.
Sensory symptoms have usually improved or resolved within months of paclitaxel discontinuation.
Sintomi sensorjali ġeneralmet tjiebu jew irrisolvew fi ftit xhur minn meta jkun twaqqaf paclitaxel.
Pre-existing neuropathies resulting from prior therapies are not a contraindication for paclitaxel therapy.
Newropatiji pre- eżistenti li kienu rriżutaw minn terapiji li ttieħdu qabel m’ humiex kontraindikati għat- terapija b’ paclitaxel
6 The other most commonly reported nervous system disorder is somnolence, which affected 14% of patients.
Barra minn dawn, il- ħedla kienet id- disturb l- ieħor l- aktar komuni rraportat li affetwa s- sistema nervuża u li affettwa 14% tal- pazjenti
Arthralgia was reported in 32% of all patients (5% severe) and myalgia in 47% (6% severe).
L- artralġja kienet irrappurtata f’ 32% tal- pazjenti kollha (5% serji) u l- majalġja f’ 47% (6% serji).
Injection site reactions including reactions secondary to extravasation were usually mild and consisted of erythema, tenderness, skin discoloration, or swelling at the injection site but can result in cellulitis.
Reazzjonijiet fis- sit ta ’ l- injezzjoni, li jinkludu reazzjonijiet sekondarji għall- estravażjoni kienu ġeneralment ħfief u jikkonsistu minn eritema, tenerezza tal- ġilda, telf tal- kulur tal- ġilda jew infiħ fis - sit ta ’ l- injezzjoni iżda jista ’ jirriżulta f’ ċellulite.
There is no known specific treatment for extravasation reactions.
Ir- rikorrenza tar- reazzjonijiet fuq il- ġilda fis- sit ta ’ estravażjoni preċedenti wara l- amministrazzjoni ta ’ paclitaxel f’ punt differenti, jiġifieri “ reazzjoni mill- ġdid ” ġiet rapportata b’ mod rari.. M’ hemm l- ebda trattament speċifiku magħruf għal reazzjonijiet ta ’ estravażjoni.
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*.
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.
Where event incidence differed between Paxene and other paclitaxel clinical studies, the most frequent incidence is presented.
Fejn kien hemm differenza fl- inċidenza bejn Paxene u studji kliniċi oħrajn b’ paclitaxel, l- ogħla inċidenza qed tiġi ppreżentata.
The frequency of undesirable effects listed below is defined using the following convention:
Il- frekwenza ta ’ l- effetti mhux mixtieqa huma elenkati hawn isfel, u huma mfissra skond il - konvenzjoni li ġejja:
Very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000), including isolated reports.
Komuni ħafna (≥1/ 10); komuni (≥1/ 100, < 1/ 10); mhux komuni (≥1/ 1. 000, < 1/ 100); rari (≥1/ 10. 000, < 1/ 1. 000); rari ħafna (< 1/ 10. 000), inklużi rapporti iżolati.
Very common: infection (including herpes simplex, oral candidiasis, pharyngitis, rhinitis)
Komuni ħafna: infezzjoni (li jinkludi herpes simplex, kandidjasi orali, farinġite, rinite)
Common: flu syndrome
Komuni: sindromu ta’ l- influwenza
Uncommon: severe infections, septic shock
Mhux komuni: infezzjonijiet serji, xokk settiku
Rare*: pneumonia Blood and lymphatic system disorders:
Rari *: pulmonite
Very common: severe neutropenia, severe leucopenia, thrombocytopenia, anaemia, myelosuppression
Komuni ħafna: newtropenja serja, lewkopenja serja, Disturbi tad- demm u tas- sistema tromboċitopenija, anemija, majelosoppressjoni limfatika:
Common: neutropenic fever
Komuni: deni newtropeniku
Uncommon: severe anaemia
7 Mhux komuni: anemija serja
Very rare*: acute myeloid leukaemia, myelodysplastic syndrome Immune system disorders:
Rari ħafna *: lewkimja majelojde akuta, sindromu majelodisplastika Disturbi tas- sistema immunitarja:
Very common: minor hypersensitivity reactions (mainly flushing and rash)
Komuni ħafna: reazzjonijiet ta ’ sensittività eċċessiva minuri (prinċìpalment ħmura u raxx)
(delayed) hypersensitivity, significant hypersensitivity reactions requiring therapy (e. g., hypotension, angioneurotic oedema, respiratory distress, generalised urticaria)
Mhux komuni: reazzjonijiet ta ’ sensittività eċċessiva( mdewma), reazzjonijiet ta sensittività eċċessiva li jinħtieġu l- kura (p. e., pressjoni baxxa, edema anġjonewrotika, disturb respiratorju, urtikarja ġeneralizzata)
Rare*: anaphylactic reactions
Rari *: reazzjonijiet anafilatiċi
Very rare*: anaphylactic shock (including fatal hypersensitivity) Metabolism and nutrition disorders:
Rari ħafna *: xokk anafilattiku (li tinkludi sensittività eċċessiva li twassal għal mewt)
Very common: anorexia Uncommon: dehydration, weight loss and gain
Komuni ħafna: anoreksja Mhux komuni: diżidrattazzjoni, telf jew żieda fil- piż
Very rare*: confusional state
Rari ħafna *: stat ta ’ konfużjoni
7 Nervous system disorders:
Disturbi tas- sistema nervuża
Very common: neuropathy (mainly peripheral), paraesthesia, somnolence
Komuni ħafna: newropatija (prinċipalment periferali), paraestesija, ngħas
Common: severe neuropathy (mainly peripheral), dizziness, nervousness, insomnia, depression, abnormal thinking, hypokinesia, abnormal gait, hypaesthesia, taste perversion, headache
Komuni: newropatija serja (prinċipalment periferali), sturdament, nervi, nuqqas ta ’ rqad, depressjoni, ħsibijiet mhux normali, ipokinesja, pass mhux normali, ipestesja, bidla fit- togħma, uġigħ ta ’ ras.
Rare*: motor neuropathy (with resultant minor distal weakness)
Rari: newropatija motorili (b’ riżultat ta dgħjufija minuri fil - parti distali)
Very rare*: acute encephalopathy, autonomic neuropathy (resulting in paralytic ileus and orthostatic hypotension), seizures
Rari ħafna *: enċefalopatija akuta; newropatija awtonomika (li tirriżulta f’ ilju paralitiku u ipotensjoni ortostatika), aċċessjonijiet
Uncommon: dry eyes, amblyopia, visual field defect
Mhux komuni: għajnejn xotti, ambliopija, disturbi fil- vista
Very rare*: optic nerve and/ or visual disturbances (scintillating scotoma), particularly in patients who have received higher doses than recommended
Rari ħafna: disturbi tan- nerv ottiku u/ jew disturbi viżwali (skotomata xintillanti) b’ mod partikolari f’ pazjenti li rċevew dożi ogħla minn dawk rakkomandati.
Ear and labyrinth disorders:
Disturbi fil- widnejn u sistema labrintika:
Very rare*: sensorineural hearing loss, vertigo
Komuni: tinnitu Rari ħafna *: telf tas- smiegħ sensorinewrali, vertigo
Common: tachycardia, palpitation, bradycardia, syncope
Komuni: takikardja, palpitazzjoni, bradikardja, sinkope.
Uncommon: congestive heart failure, cardiomyopathy, asymptomatic ventricular tachycardia, tachycardia with bigeminy, AV block and syncope, myocardial infarction
Mhux komuni: insuffiċjenza tal- qalb konġestiva, kardjomijopatija, takikardja asimptomatika ventrikulari, takikardja b’ biġemini, Blokk AV u sinkope, infart mijokardijaku
Very rare*: atrial fibrillation Vascular disorders:
Rari ħafna *: fibrillazzjoni atrijali Disturbi vaskulari
Very common: hypotension
Komuni ħafna: pressjoni baxxa
Common: vasodilatation (flushing)
8 Komuni: vażodilazzjoni (ħmura)
Uncommon: thrombophlebitis, hypertension, thrombosis
Mhux komuni: tromboflebite, pressjoni għolja, trombożi
Very rare*: shock Respiratory, thoracic and mediastinal disorders:
Rari ħafna *: xokk Disturbi respiratorji, toraċiċi u medjastinali:
Common: dyspnoea, epistaxis Rare: pleural effusion, lung fibrosis
Komuni: dispneja, epistassi Rari: nixxiegħa mill- plewre, Fibrożi tal- pulmun
Very rare*: cough, pulmonary hypertension
Rari ħafna *: sogħla, pressjoni pulmonari għolja ħafna
Very common: nausea, vomiting, diarrhoea, mucosal inflammation, constipation, stomatitis, abdominal pain
Komuni ħafna: tqalligħ, rimettar, dijarrea, infjammazzjoni tal- mukosa, stitikezza, stomatite, uġigħ fl- addome
Common: dry mouth, mouth ulceration, melaena, dyspepsia
Komuni: ħalq xott, ulċerazzjoni fil- ħalq, melena, dispepsja
Very rare*: bowel obstruction, bowel perforation, pseudomembranous colitis, ischemic colitis, mesenteric thrombosis, necrotising enterocolitis, oesophagitis, ascites, acute pancreatitis
Rari ħafna *: sadd ta ’ l- imsaren, imsaren ipperforati, kolite psewdomembranja, kolite iskemika, trombosi meżentrika, eneterokolite nekrotizzanti, esofagite, axxite, pankreatite akuta
Hepatobiliary disorders:
Disturbi fil- fwied u l- marrara:
Very rare*: hepatic necrosis, hepatic encephalopathy
Rari ħafna: nekrosi ħepatika; enċefalopatija ħepatika
8
Disturbi tal- ġilda u t- tessuti taħta:
Skin and subcutaneous tissue disorders:
Komuni ħafna: alopeċja
Very common: alopecia Common: transient skin change, dry skin, exfoliative dermatitis, pruritis, rash, acne, transient and mild nail changes
Komuni: bdil għaddieni fil- ġilda, ġilda xotta, dermatite eksfoljattiva, dermatite, ħakk, raxx, akne, bdil ħafif fid - dwiefer li jgħaddi
Uncommon: changes in nail pigmentation or discoloration of nail bed
Mhux komuni: bidla fil- pigmentazzjoni tad- dwiefer jew tal - bażi tad- difer)
Rare*: erythema
Rari *: eritema
Stevens-Johnson syndrome, epidermal necrolysis, erythema multiforme, urticaria, onycholysis (patients on therapy should wear sun protection on hands and feet)
Rari ħafna: sindromu ta ’ Stevens- Johnson, nekroliżi epidermali, eritema multiforme, urtikarja, onikolożi (pazjenti fuq it- terapija għandhom jilbsu protezzjoni kontra x- xemx fuq l- idejn u r- riġlejn)
Musculoskeletal and connective tissue disorders:
Disturbi muskolu- skeletriċi u tat - tessut konnettiv:
Very common: arthralgia, myalgia Common: bone pain, leg cramps, myasthenia, back pain
Komuni ħafna: artalġja, uġigħ fil- muskoli Komuni: uġigħ fl- għadam, bugħawwieġ fir- riġlejn, mijastenja uġigħ fid- dahar
Common: dysuria
Komuni: disurja
General disorders and administration site conditions:
Disturbi ġenerali u kundizzjonijiet ta 'mnejn jittieħed:
Common: mild injection site reactions (erythema, tenderness, skin discoloration or swelling, pain, extravasation, can result in cellulitis and skin ulceration), malaise, chest pain, chills, pyrexia
Komuni ħafna: astenja, uġigħ, edema inkluża periferali u tal - wiċċ Komuni: reazzjonijiet ħfief fis- sit ta ’ l- injezzjoni (eritema, tenerezza tal- ġilda, telf tal- kulur jew infieħ tal- ġilda, uġigħ, estravażjoni, jista ’ jirriżulta f’ ċellolite u ulċerazzjoni tal - ġilda), telqa tal- ġisem, uġigħ fis- sider, sirdat, deni
Investigations:
Stħarriġ:
Common: severe elevation in transaminases, severe elevation in alkaline phosphatase
Komuni: il- livell ta ’ transaminases għola b’ mod qawwi; il - livell ta alkaline phosphatase għola b’ mod qawwi
Uncommon: severe elevation in bilirubin
Bilirubin għola b’ mod serju
Combination therapy
Terapija Kombinata
The following discussion refers to two major trials for the first-line chemotherapy of ovarian cancer (paclitaxel + cisplatin: over 1050 patients) and two Phase III trials for the treatment of advanced NSCLC (paclitaxel + cisplatin: over 360 patients) (see section 5.1).
Id- diskussjoni li ġejja tirreferi għal żewġ provi kliniċi ewlenin li saru għall- kemoterapija bħala l- kura preferuta tal- kanċer ta ’ l- ovarju (paclitaxel + cisplatin: 'l fuq minn 1050 pazjent) u żewġ provi kliniċi ta ’ Fażi III għall- kura avvanzata ta ’ NSCLC (paclitaxel + cisplatin:' l fuq minn 360 pazjent) (ara sezzjoni 5. 1).
When administered as a 3 hour infusion for the first-line chemotherapy of ovarian cancer, neurotoxicity, arthralgia/ mayalgia, and hypersensitivity were reported as more frequent and severe by patients treated with paclitaxel followed by cisplatin than patients treated with cyclophosphamide followed by cisplatin.
Meta mogħti bħala infużjoni ta ’ 3 sigħat bħala l- kemoterapija fil- kura preferuta għal kanċer ta ’ l - ovarju, il- frekwenza ta ’ rapporti minn pazjenti għal newrotossiċità, artralġja/ majalġja u sensittività eċċessiva kienu ogħla u kienu aktar serji meta dawn kienu kkurati b’ paclitaxel segwit minn cisplatin aktar milli għal pazjenti kkurati b’ cyclophosphamide segwit minn cisplatin.
Myelosuppression appeared to be less frequent and severe with paclitaxel as a 3 hour infusion followed by cisplatin compared with cyclophosphamide followed by cisplatin.
Il- majelosoppressjoni dehret li hi inqas frekwenti u serja meta paclitaxel ingħata bħala infużjoni fuq tlett sigħat segwita minn cisplatin meta mqabbla ma ’ cyclophosphamide segwit minn cisplatin.
Neurotoxicity, mainly peripheral neuropathy, appeared to be more frequent and severe with a 175 mg/ m2 3 hour infusion (85% neurotoxicity, 15% severe) than with a 135 mg/ m2 24 hour infusion (25% peripheral neuropathy, 3% severe) when paclitaxel was combined with cisplatin.
In- newrotossiċità, prinċipalment in- newropatija periferika dehret li hi aktar frekwenti u serja 2 b’ infużjoni ta’ 175 mg/ m mogħtija fuq 3 sigħat (85% newrotossiċità, 15% serja) milli b’ infużjoni ta ’ 2 135 mg/ m mogħtija fuq 24 siegħa (25% newropatija periferali, 3% serja) meta paclitaxel ingħata flimkien ma’ cisplatin.
In NSCLC and ovarian cancer patients treated with paclitaxel over 3 hours followed by cisplatin, there is an apparent increase in the incidence of severe neurotoxicity.
F’ pazjenti b’ NSCLC u b’ kanċer ta ’ l- ovarju kkurati b’ paclitaxel fuq tlett sigħat segwit minn cisplatin, hemm żieda apparenti fl- inċidenza ta ’ newrotossiċità serja.
Peripheral neuropathy can occur following the first course and can worsen with increasing exposure to paclitaxel.
Newropatija periferali tista ’ sseħħ wara l- ewwel kors ta ’ kura u tista ’ tiggrava b’ esponiment akbar għal paclitaxel.
Peripheral neuropathy was the cause of paclitaxel discontinuation in a few cases.
In- newropatija periferali kienet il- kawża tal- waqfin ta paclitaxel fi ftit każijiet.
Sensory symptoms have usually improved or resolved within months of paclitaxel discontinuation.
Sintomi sensorjali ġeneralment marru għal aħjar jew irrisolvew rwieħom xhur wara li twaqqaf paclitaxel.
Pre-existing neuropathies resulting from prior therapies are not a contraindication for paclitaxel therapy.
Newropatiji li kienu jeżistu minn qabel, li rriżultaw minn terapiji mogħtija qabel, mhumiex kontraindikazzjoni għat - terapija b’ paclitaxel.
9 In eight published clinical trials (8 Phase III trials) including 4735 patients with advanced ovarian cancer and in twelve published clinical trials (one large Phase II and eleven Phase III trials) including 4315 NSCLC patients treated with paclitaxel and platinum-containing regimens, similar undesirable effects were observed compared to single-agent paclitaxel treatment.
Fi tmien provi kliniċi ppubblikati (8 provi ta ’ Fażi III) li kienu jinkludu 4735 pazjent b’ kanċer ta ’ l - ovarju avvanzat u fi tnax- il prova klinika ppubblikata (prova kbira ta ’ Fażi II u ħdax- il prova ta ’ Fażi III) li kienu jinkludu 4315- il pazjent b’ NSCLC, pazjenti kkurati b’ paclitaxel u reġimeni li kien fihom il- platinu, effetti mhux mixtieqa bħal dawn kienu osservati meta mqabbla mal- kura mogħtija b’ paclitaxel biss.
Additionally ileus, effects on creatinine clearance, abnormal electrolytes (e. g. hyponatremia, hypomagnesemia), hyperglycaemia, cough and pneumonia occurred very rarely.
Barra minn hekk, ilejus, effetti fuq ir- rata ta ’ l- eliminazzjoni tal- krejatinina, elettroliti anormali (p. e. iponatremja, ipomagnesemja) ipergliċemija, sogħla, u pulmonite kienu rari ħafna.
Pneumonitis in patients receiving concomitant radiotherapy and/ or gemcitabine has been reported very rarely.
Rapporti ta’ pnewmonite f’ pazjenti li kienu qed jirċievu radjoterapija flimkien ma ’ / jew gemcitabine kienu rari.
AIDS related Kaposi’ s sarcoma
Sarkoma ta ’ Kaposi relatata ma ’ l- AIDS
The following undesirable effects relate to 107 AIDS-KS patients treated with 100 mg/ m2 Paxene administered as a 3 hour infusion as second-line chemotherapy in a clinical study, and were considered possibly or probably related to Paxene.
Ir- reazzjonijiet mhux mixtieqa li ġejjin jirrelataw għal 107 pazjenti b’ AIDS- KS kkurati b’ 100 mg / m2 Paxene mogħti bħala infużjoni ta 3 sigħat bħala t- tieni kura kemjoterapewtika ppreferuta fi studju kliniku u kienu kkonsidrati li possibilment jew probabilment huma relatati ma ’ Paxene.
Except for haematological and hepatic events (see below), generally the frequency and severity of undesirable effects in AIDS-KS patients were similar to those noted in patients with other solid tumours treated with paclitaxel monotherapy.
Ħlief f’ każijiet ematoloġiċi u ħepatiċi (ara isfel), ġeneralment il- frekwenza u s- severittà ta ’ effetti mhux mixtieqa f ’ pazjenti li jbatu minn AIDS- KS kienu bħal dawk notati f’ pazjenti li għandhom tumuri solidi oħrajn, ikkurati b ’ paclitaxel bħala monoterapija.
Severe neutropenia (< 500 cells/ mm3) occurred in 20% and 39% of patients during the first course of treatment and the entire treatment period respectively.
Newtropenja serja (< 500 ċellula/ mm3) seħħet f’ 20% u f’ 39% ta ’ pazjenti kkurati b’ Paxene fl- ewwel kors ta ’ kura u għal tul il- perijodu kollu rispettivament.
Neutropenia was present for > 7 days in 41% and for 30-35 days in 8% of patients.
In - newtropenja kienet preżenti għal > 7 ijiem f’ 41% u għal 30- 35 jum fi 8% tal- pazjenti.
Neutropenia resolved in 35 days in all patients who were followed.
In- newtropenja għaddiet f’ 35 jum fil- pazjenti kollha li ġew segwiti.
The incidence of Grade 4 neutropenia lasting 7 days or more was 22%.
L- inċidenza ta ’ newtropenija ta ’ Grad 4 li ddum 7ijiem jew aktar kienet ta ’ 22%.
Neutropenic fever related to Paxene was reported in 14% of patients.
Id- deni newtropeniku relatat ma ’ Paxene kien rapportat f’ 14% tal - pazjenti.
There were three septic episodes (2.8%) during Paxene administration related to the medicinal product that proved fatal.
Ken hemm tlett każijiet (2. 8%) ta ’ sepsis relatati mal- prodott mediċinali li rriżultaw fil- mewt.
Thrombocytopenia was observed in 50% of patients, and was severe (< 50,000 cells/ mm3) in 9%.
It- tromboċitopenja kienet osservata f’ 50% tal- pazjenti u kienet serja (< 50, 000 ċellula/ mm3) f’ 9% minnhom.
Anaemia (Hb < 11 g/ dL) was observed in 61% of patients and was severe (Hb < 8 g/ dL) in 10%.
Każijiet ta ’ fsada relatati ma ’ Paxene kienu rapportati f ’ < 3% tal- pazjenti u l- fsada kienet lokalizzata. L- anemija (Hb < 11 g/ dl) ġiet osservata f’ 61% tal- pazjenti u kienet preżenti b’ mod serju (Hb < 8 g/ dl) f’ 10%.
Red cell transfusions were required in 21% of patients.
F’ 21% tal- pazjenti kien hemm bżonn ta ’ trasfużjonijiet taċ- ċelluli l- ħomor.
Among patients (> 50% on protease inhibitors) with normal baseline liver function, 28%, 43% and 44% had elevations in bilirubin, alkaline phosphatase and AST (SGOT), respectively.
10 Fost il- pazjenti (> 50% ta ’ impedituri ta ’ protease) li kellhom livell normali ta ’ referenza bażi għal funzjoni tal- fwied 28%, 43% u 44% kellhom livelli ogħla ta ’ bilirubin, alkaline phosphatase u AST (SGOT) rispettivament.
For each of these parameters, the increases were severe in 1% of cases.
Għal kull wieħed minn dawn il- parametri, iż- żiedet kienu serji f’ 1% tal - każijiet
No known antidote exists for Paxene overdose.
L- ebda antidot magħruf ma jeżisti għal doża eċċessiva ta ’ Paxene.
In the event of an overdose, the patient should be closely monitored.
Fil- każ ta ’ doża eċċessiva, il - pazjent għandu jiġi osservat mill- qrib.
Treatment should be directed at the major anticipated toxicities, which are bone marrow suppression, mucositis and peripheral neuropathy.
It- trattament għandu jkun dirett lejn it- tossiċitajiet maġġuri antiċipati, li huma t- trażżin tal- mudullun, mukosite u newropatija periferika.
Antineoplastic agents (taxanes), ATC code:
Aġenti antinejoplastiċi (taxanes), Kodiċi ATC:
The active substance of Paxene is paclitaxel.
Is- sustanza attiva ta ’ Paxene hija paclitaxel.
The exact mechanism of the antitumour activity of paclitaxel is not known.
Il- mekkaniżmu eżatt ta ’ l- attività anti- tumurili ta ’ paclitaxel mhix magħrufa.
It is generally believed that paclitaxel promotes the assembly of microtubules from tubulin dimer and prevents depolymerisation.
Huwa ġeneralment emnut li paclitaxel iqanqal il- muntaġġ ta ’ mikrotubi mid- dimer ta ’ tubilin u jimpedixxi depolimerizzazzjoni.
Stabilisation results in the inhibition of the normal dynamic reorganisation of the microtubular network that is essential for vital interphase and mitotic cellular functions.
L- istabilizzazzjoni tirriżulta fl- impediment tar- re- organizzazzjoni dinamika tax- xibka mikrotubulari li hi meħtieġa għal funzjonijiet ta ’ interfażi vitali u ċellulari mitotiċi.
In addition, paclitaxel induces bundles of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis.
Barra minn hekk, paclitaxel jissensitizza soror ta ’ mikrotubi waqt iċ- ċiklu taċ- ċellula u asters multipli ta ’ mikrotubi waqt il- mitosi.
Metastatic breast cancer:
Kanċer tas- sider fl- istat metastatiku:
10 The efficacy and safety of Paxene (175 mg/ m² over 3 hours at 3-week intervals) in refractory metastatic breast cancer were investigated in 172 women in a multicentre, open-label Phase III trial.
L- effikaċja u sigurtà ta ’ Paxene (175 mg/ m² mogħtija fuq 3 sigħat f’ intervalli ta’ tlett ġimgħat) f’ kanċer tas- sider fi stat metastatiku refrattorju ġie investigat f’ 172 mara fi prova ta ’ Fażi III multiċentrali, bit - tikketta murija.
The clinical response rate was 18.5%, median time to progression was 2.8 months (CI:
Ir- rata ta ’ rispons kliniku kienet ta ’ 18. 5%, iż- żmien medjan ta ’ firxa kienet ta ’ 2. 8 xhur (CI:
2.1 - 3.3 months) and the median survival time was 9.9 months (CI:
2. 1 – 3. 3 xhur) u ż- żmien medjan ta ’ sopravivenza kienet ta ’ 9. 9 xhur (CI:
7.8 - 13.1 months).
7. 8 – 13. 1 xhur).
The results obtained with Paxene are closely similar to those of published paclitaxel Phase III trials.
Ir- riżultati miksuba b’ Paxene kienu jixbħu ħafna lil dawk ippublikati għal paclitaxel fil- provi kliniċi ta ’ Fażi III.
Advanced ovarian cancer (first-line treatment):
Kanċer ta ’ l- ovarju avvanzat (il- kura preferuta)