qanastek/EMEA-V3 huggingface dataset:
8 mg BID) for 3 days starting 1 day prior to docetaxel administration, unless contraindicated, can reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions.
Dan jista ’ jnaqqas l- inċidenza u s- severità taż- żamm ta ’ fluwidu kif ukoll is- severità ta ’ reazzjonijiet ta ’ sensittività eċċessiva.
For prostate cancer, the premedication is oral dexamethasone 8 mg, 12 hours, 3 hours and 1 hour before the docetaxel infusion (see section 4.2).
Għal kanċer tal- prostata, il- premedikazzjoni hija t- teħid orali ta ’ dexamethasone ta ’ 8 mg, 12- il siegħa, 3 sigħat u siegħa qabel l- infużjoni ta’ docetaxel (ara sezzjoni 4. 2).
Neutropenia is the most frequent adverse reaction of docetaxel.
In- newtropenija hija l- aktar reazzjoni avversa u komuni ta ’ docetaxel.
Neutrophil nadirs occurred at a median of 7 days but this interval may be shorter in heavily pre-treated patients.
In- nadir taċ- ċelluli newtrofiliċi ġraw f’ medjan ta ’ 7 ijiem, iżda dan l- intervall jaf ikun iqsar f’ dawk il- pazjenti li kienu diġa ikkurati b’ doża qawwija qabel.
Frequent monitoring of complete blood counts should be conducted on all patients receiving docetaxel.
Moniteraġġ frekwenti permezz ta ’ l- għadd sħiħ taċ- ċelluli tad- demm hu xieraq li ssir fil- pazjenti kollha li qegħdin jirċievu docetaxel.
Patients should be retreated with docetaxel when neutrophils recover to a level ≥ 1,500 cells/ mm3 (see section 4.2).
Il- pazjenti għandhom jerġgħu jkunu ikkurati mill- ġdid b’ docetaxel meta ċ- ċelluli newtrofiliċi jirkupraw biex jilħqu livell ta ’ ≥ 1, 500 ċelluli/ mm3 (ara sezzjoni 4. 2).
In the case of severe neutropenia (< 500 cells/ mm3 for seven days or more) during a course of docetaxel therapy, a reduction in dose for subsequent courses of therapy or the use of appropriate symptomatic measures are recommended (see section 4.2).
F’ każi ta ’ newtropenija severa (< 500 ċelluli/ mm3 għal sebat ijiem jew aktar) waqt kors ta ’ terapija b’ docetaxel, it- tnaqqis fid- doża għall- korsijiet sussegwenti ta ’ terapija jew it- teħid ta ’ miżuri sintommatiċi adatti huwa irrakkomandat (ara sezzjoni 4. 2).
6 In patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (TCF), febrile neutropenia and neutropenic infection occurred at lower rates when patients received prophylactic G-CSF.
F’ pazjenti ittrattati b’ docetaxel flimkien ma ’ cisplatin u 5- fluorouracil (TCF), in- newtropenija bid- deni jew in- newtropenija assoċjata ma ’ infezzjoni ġraw f’ rati aktar baxxi f’ pazjenti li ngħataw il- profilassi bil- G- CSF.
Patients treated with TCF should receive prophylactic G-CSF to mitigate the risk of complicated neutropenia (febrile neutropenia, prolonged neutropenia or neutropenic infection).
Il- pazjenti ittrattati b’ TCF għandhom jingħataw il- profilassi b’ G- CSF biex jonqos ir- riskju tan- newtropenija komplikata (newtropenija bid- deni, newtropenija fit- tul jew in- newtropenija assoċjata ma ’ infezzjoni).
Patients receiving TCF should be closely monitored (see sections 4.2 and 4.8).
Il- pazjenti li qed jieħdu TCF għandhom ikunu immoniterjati mill- qrib (ara sezzjonijiet 4. 2 u 4. 8).
Hypersensitivity reactions
Reazzjonijiet ta ’ sensittività eċċessiva
Patients should be observed closely for hypersensitivity reactions especially during the first and second infusions.
Il- pazjenti għandhom ikunu osservati mill- qrib għal reazzjonijiet ta ’ sensittvità eċċessiva speċjalment waqt l- ewwel u t- tieni infużjoni.
Hypersensitivity reactions may occur within a few minutes following the initiation of the infusion of docetaxel, thus facilities for the treatment of hypotension and bronchospasm should be available.
Ir- reazzjonijet ta ’ sensittività eċċessiva jistgħu jiġru fi żmien ftit minuti wara l- bidu ta ’ l- infużjoni ta ’ docetaxel, għalhekk, faċilitajiet għat- trattament tal- pressjoni baxxa u l- ispażmu tal- bronki jridu jkunu disponibbli.
If hypersensitivity reactions occur, minor symptoms such as flushing or localised cutaneous reactions do not require interruption of therapy.
Jekk ikun hemm reazzjonijiet ta ’ sensittività eċċessiva, sintomi minuri bħall- fwawar jew reazzjonijiet lokalizzati fil- ġilda, ma jirrikjedux l - interruzzjoni tat- terapija.
However, severe reactions, such as severe hypotension, bronchospasm or generalised rash/ erythema require immediate discontinuation of docetaxel and appropriate therapy.
Madankollu, reazzjonijiet severi bħall- pressjoni baxxa u severa tad- demm, spażmu tal- bronki jew raxx/ ħmura ġeneralizzat/ a jirrikjedu il- waqfa minnufih ta ’ docetaxel u li tingħata terapija adatta.
Patients who have developed severe hypersensitivity reactions should not be re-challenged with docetaxel.
Il- pazjenti li żviluppaw reazzjonijiet ta ’ sensittività eċċessiva severi m’ għandux jerġa ’ jingħatalhom docetaxel.
Cutaneous reactions
Reazzjonijiet fil- ġilda
Localised skin erythema of the extremities (palms of the hands and soles of the feet) with oedema followed by desquamation has been observed.
Ħmura lokaliżżata tal- ġilda fl- estremitajiet (il- pali ta ’ l- idejn u tas- saqajn) flimkien ma ’ nefħa, segwiti mid- deskwamazzjoni tal- ġilda kienu osservati.
Severe symptoms such as eruptions followed by desquamation which lead to interruption or discontinuation of docetaxel treatment were reported (see section 4.2).
Sintomi severi bħal msiemer fil- ġilda segwit b’ deskwamazzjoni li jwasslu għall- interuzzjoni jew il- waqfien tat- trattament b’ docetaxel kienu irrapportati (ara sezzjoni 4. 2).
Fluid retention
7 Iż- żamm ta ’ fluwidu
Patients with severe fluid retention such as pleural effusion, pericardial effusion and ascites should be monitored closely.
Pazjenti li għandhom żamm sever ta ’ fluwidu bħall- effużjoni fil- kavità tal- plewra, effużjoni fil - perikardju u l- axxite, għandhom ikunu immoniterjati mill- qrib.
Patients with liver impairment
Pazjenti b’ indeboliment tal- fwied
In patients treated with docetaxel at 100 mg/ m2 as single agent who have serum transaminase levels (ALT and/ or AST) greater than 1.5 times the ULN concurrent with serum alkaline phosphatase levels greater than 2.5 times the ULN, there is a higher risk of developing severe adverse reactions such as toxic deaths including sepsis and gastrointestinal haemorrhage which can be fatal, febrile neutropenia, infections, thrombocytopenia, stomatitis and asthenia.
F’ pazjenti ikkurati b’ docetaxel waħdu b’ doża ta ’ 100 mg/ m2, u li għandhom livelli ta ’ l- enzimi transaminase (l- ALT u/ jew l- AST) fis- serum tad- demm aktar minn 1. 5 drabi l- ULN, flimkien ma ’ livelli ta ’ l- enżima alkaline phosphatase fis- serum aktar minn 2. 5 drabi l- ULN, ghandhom riskju akbar li jiżviluppaw reazzjonijiet avversi u severi, bħall- mewt ta ’ natura tossika inkluża s- sepsis, emoraġija gastro- intestinali li tista ’ tkun fatali, newtropenija bid- deni, infezzjonijiet, tromboċitopenija, stomatite, u astenja.
Therefore, the recommended dose of docetaxel in those patients with elevated liver function test (LFTs) is 75 mg/ m2 and LFTs should be measured at baseline and before each cycle (see section 4.2).
Għalhekk, id- doża irrakkomandata ta ’ docetaxel f’ dawk il- pazjenti li għandhom livelli għolja fit- testijiet tal- funzjoni tal- fwied (LFTs) huwa 75 mg/ m2 u l- LFTs irid jiġi meqjus fil- bidu u qabel kull ċiklu ta ’ trattament (arasezzjoni 4. 2).
For patients with serum bilirubin levels > ULN and/ or ALT and AST > 3.5 times the ULN concurrent with serum alkaline phosphatase levels > 6 times the ULN, no dose-reduction can be recommended and docetaxel should not be used unless strictly indicated.
Għal dawk il- pazjenti li għandhom livelli ta ’ bilirubin fis- serum > ULN u/ jew l- ALT u l- AST > 3. 5 drabi mill- ULN, flimkien ma ’ livelli ta ’ alkaline phosphotase fis- serum tad- demm huwa > 6 drabi l - ULN, ebda tnaqqis fid- doża ma jista ’ jkun irrakkomandat, u docetaxel m’ għandux jintuża sakemm mhux strettament indikat.
In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical trial excluded patients with ALT and/ or AST > 1.5 × ULN associated with alkaline phosphatase > 2.5 × ULN, and bilirubin > 1 x ULN; for these patients, no dose-reductions can be recommended and docetaxel should not be used unless strictly indicated.
Meta cisplatin u 5- fluorouracil intużaw flimkien għat- trattament ta ’ pazjenti li kellhom adenokarċinoma ta ’ l- istonku, il- prova tal- pern eskludiet pazjenti b’ ALT u/ jew AST > 1. 5 x ULN assoċjat ma ’ alkaline phosphatase ta ’ > 2. 5 x ULN, u bilirubin ta ’ > 1 x ULN; għal dawn il- pazjenti ma jistgħux ikunu irrakkomandati tnaqqis fid- dożi u docetaxel m’ għandux jintuża sakemm mhux strettament indikat.
No data are available in patients with hepatic impairment treated by docetaxel in combination in the other indications.
M’ hemmx data f’ pazjenti li għandhom indebolimenttal- fwied ittrattati b’ docetaxel flimkien ma ’ sustanza( i) oħra( ohrajn) fl- indikazzjonijiet l- oħra.
Patients with renal impairment
Pazjenti b’ indeboliment tal- kliewi
There are no data available in patients with severely impaired renal function treated with docetaxel.
M’ hemmx data disponibbli f’ pazjenti li għandhom indeboliment sever fil- funzjoni tal- kliewi u li kienu ittrattati b’ docetaxel.
Nervous system
Sistema nervuża
The development of severe peripheral neurotoxicity requires a reduction of dose (see section 4.2).
L- iżvilupp ta ’ newrotossiċità severa periferika jirrikjedi tnaqqis fid- doża (ara sezzjoni 4. 2).
7 Cardiac toxicity
Tossiċità kardijaka
Heart failure has been observed in patients receiving docetaxel in combination with trastuzumab, particularly following anthracycline (doxorubicin or epirubicin)-containing chemotherapy.
Insuffiċjenza tal- qalb intweriet f’ pazjenti li hadu docetaxel flimkien ma ’ trastuzumab, specjalment wara l- kimoterapija li fiha anthracycline (doxorubicin jew epirubicin).
This may be moderate to severe and has been associated with death (see section 4.8).
Din tista ’ tkun moderata għal severa u kienet assoċjata mal- mewt (ara sezzjoni 4. 8).
When patients are candidates for treatment with docetaxel in combination with trastuzumab, they should undergo baseline cardiac assessment.
Meta jkun xieraq li pazjenti jieħdu it- trattament ta ’ docetaxel flimkien ma ’ trastuzumab, ghandha tkun assessjata l- linja bażi tal- funzjoni tal- qalb.
Cardiac function should be further monitored during treatment (e. g. every three months) to help identify patients who may develop cardiac dysfunction.
Il- funzjoni kardijaka għandha tkun immoniterjata ukoll waqt it- trattament (e. g. kull tliet xhur) biex tgħin ħalli l- pazjenti li jistghu jiżviluppaw problemi fil - funzjoni kardijaka jkunu identifikati.
For more details see summary of product characteristics of trastuzumab.
Għal aktar dettalji ara s- sommarju tal- karatteristiċi tal- prodott ta ’ trastuzumab.
Others
Oħrajn
Contraceptive measures must be taken during and for at least three months after cessation of therapy.
Miżuri kontraċettivi għandhom jittieħdu waqt u mhux inqas minn tliet xhur wara t- twaqqif tat- terapija.
Additional cautions for use in adjuvant treatment of breast cancer Complicated neutropenia For patients who experience complicated neutropenia (prolonged neutropenia, febrile neutropenia or infection), G-CSF and dose reduction should be considered (see section 4.2).
Miżuri oħra ta ’ kawtela fl- użu tat- trattament miżjud tal- kanċer tas- sider Newtropenija Komplikata Ghal dawk il- pazjenti li jiżviluppaw newtropenija komplikata (newtropenija fit- tul, newtropenija bid - deni jew b’ infezzjoni), għandhom jitqiesu l- użu ta ’ G- CSF u t- tnaqqis fid- doża (ara sezzjoni 4. 2).
Gastrointestinal reactions Symptoms such as early abdominal pain and tenderness, fever, diarrhea, with or without neutropenia, may be early manifestations of serious gastrointestinal toxicity and should be evaluated and treated promptly.
8 Reazzjonijiet gastro- intestinali Sintomi bħal uġigħ addominali bikri u sensibilità, deni, dijarea, bin- newtropenija u mingħajrha, jistgħu jkunu l- ewwel sinjali ta ’ tossiċità serja gastro- intestinali u għandhom ikunu evalwati u ittrattati fil - pront.
Congestive heart failure Patients should be monitored for symptoms of congestive heart failure during therapy and during the follow up period.
Insuffiċjenza konġestiva tal- qalb Il- pazjenti għandhom ikunu immoniterjati għal sintomi ta ’ insuffiċjenza konġestiva tal- qalb waqt it - terapija u waqt il- perijodu ta ’ wara t- trattament.
Leukemia In the docetaxel, doxorubicin and cyclophosphamide (TAC) treated patients, the risk of delayed myelodysplasia or myeloid leukemia requires haematological follow-up.
Lewkimja Fil- pazjenti ittrattati b’ docetaxel, doxorubicin u cyclophosphamide (TAC), ir- riskju li jiżviluppaw myelodysplasia jew lewkimija tat- tip myeloid, fit- tard, jirrikjedi l- immoniterjar ematoloġiku wara t - trattament.
Patients with 4+ nodes The benefit/ risk ratio for TAC in patients with 4+ nodes was not defined fully at the interim analysis (see section 5.1).
Pazjenti b ’ 4+ glandoli Il- benefiċċju mqabbel mar- riskju ghal TAC f’ pazjenti li għandhom 4+glandoli ma kienx delinejat sew fl- analisi ta ’ dak iż- żmien.
Elderly There are no data available in patients > 70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide.
Anzjani M’ hemmx data disponibbli f’ pazjenti li ghandhom > 70 sena u li kienu fuq docetaxel flimkien ma ’ doxorubicin u cyclophosphamide.
Of the 333 patients treated with docetaxel every three weeks in a prostate cancer study, 209 patients were 65 years of age or greater and 68 patients were older than 75 years.
Minn 333 pazjent ittrattati b’ docetaxel kull tliet ġimgħat fi studju fiq il- kanċer tal- prostata, 209 pazjent kellhom 65 sena jew aktar u 68 pazjent kienu akbar minn 75 sena.
In patients treated with docetaxel every three weeks, the incidence of related nail changes occurred at a rate ≥ 10% higher in patients who were 65 years of age or greater compared to younger patients.
F’ pazjenti ittrattati b ’ docetaxel kull tliet ġimgħat, ir- rata relatata ma ’ kambjamenti fid- dwiefer kienet ≥ 10% ogħla f’ pazjenti li kellhom 65 sena jew aktar meta mqabbel ma ’ dawk iżgħar minn 65 sena.
The incidence of related fever, diarrhea, anorexia, and peripheral edema occurred at rates ≥ 10% higher in patients who were 75 years of age or greater versus less than 65 years.
L- Incidenza relatata ma’ deni, dijarrea, anoreksja u edima periferika li ġraw b’ rati ≥ 10% ogħla fil- pazjenti li kellhom 75 sena jew aktar kontra dawk iżgħar minn 65 sena.
Among the 300 (221 patients in the phase III part of the study and 79 patients in the phase II part) patients treated with docetaxel in combination with cisplatin and 5-fluorouracil in the gastric cancer study, 74 were 65 years of age or older and 4 patients were 75 years of age or older.
Fost 300 pazjent (li 221 minnhom kienu fil fażi III ta ’ l- istudju u 79 pazjent fil- fażi II) ittrattati b’ docetaxel flimkien ma ’ cisplatin u 5- fluorouracil fl- istudju fuq il- kanċer ta ’ l- istonku, 74 pazjenti kellhom 65 sena jew aktar u 4 pazjenti kellhom 75 sena jew aktar.
The incidence of serious adverse events was higher in the elderly patients compared to younger patients.
L- inċidenza ta ’ ġrajjiet avversi u serji kien ogħla fil- pazjenti anzjani meta mqabbla ma ’ pazjenti iżgħar.
The incidence of the following adverse events (all grades): lethargy, stomatitis, neutropenic infection occurred at rates ≥ 10% higher in patients who were 65 years of age or older compared to younger patients.
L- inċidenza tal- ġrajjiet avversi li jmissu (fil- gradi kollha): telqa, stomatite u infezzjonijiet assoċjati man- newtropenija, graw f’ rati ta ’ ≥ 10% ogħla f’ pazjenti li kellhom 65 sena jew aktar, meta mqabbla ma ’ pazjenti iżgħar.
Elderly patients treated with TCF should be closely monitored.
Il- pazjenti anzjani ittrattati b’ TCF għandhom ikunu immoniterjati mill- qrib.
8 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
In vitro studies have shown that the metabolism of docetaxel may be modified by the concomitant administration of compounds which induce, inhibit or are metabolised by (and thus may inhibit the enzyme competitively) cytochrome P450-3A such as ciclosporine, terfenadine, ketoconazole, erythromycin and troleandomycin.
Studji in vitro urew li l- metaboliżmu ta ’ docetaxel jista ’ jkun immodifikat meta jittieħed ma ’ sustanzi oħrajn li jinduċu, jew jinibixxu, jew huma metaboliżżati (u, għalhekk, jistgħu jinibixxu l- enzima kompetittivament) minn ċitokroma P450- 3A, bħal ciclosporine, terfenadine, ketoconazole, erythromycin u troleandomycin.
As a result, caution should be exercised when treating patients with these medicinal products as concomitant therapy since there is a potential for a significant interaction.
B’ riżultat ta ’ dan, għandha tkun eżerċitata l- kawtela waqt it - trattament ta ’ pazjenti b’ dawn il- prodotti mediċinali meta jingħataw ma ’ docetaxel, imħabba l- potenzjal li hemm interazzjoni sinifikanti.
Docetaxel is highly protein bound (> 95%).
Docetaxel huwa marbut b’ ogħla seww mal- proteina (> 95%).
In addition, dexamethasone did not affect protein binding of docetaxel.
Għalkemm il- possibbiltà t’ interazzjoni in vivo ta ’ docetaxel ma ’ mediċini oħra li ngħatat konkomittantement ma kienux investigati formalment, l- interazzjonijiet in- vitro b’ sustanzi li huma marbuta sew mal- proteina bħal erythromycin, diphenhydramine, propranolol, propafenone, phenytoin, salicylate, sulfamethoxazole, u sodium valproate, m’ effetwawx ir- rabta ta ’ docetaxel mal- proteina; hekk ukoll dexamethasone m’ effetwawx l - effetti fuq ir- rabta ta ’ Docetaxel mal- proteina.
Docetaxel did not influence the binding of digitoxin.
Docetaxel ma kellux effetti fuq ir- rabta ta ’ digitoxin mal- proteina.
The pharmacokinetics of docetaxel, doxorubicin and cyclophosphamide were not influenced by their coadministration.
Il- komportament farmakokinetiku ta ’ docetaxel, doxorubicin u cyclophosphamide ma kienx effetwat meta ngħataw flimkien.
Limited data from a single uncontrolled study were suggestive of an interaction between docetaxel and carboplatin.
Data limitat minn studju wieħed mhux ikkontrollat, issuġġerixxa xi interazzjoni bejn docetaxel u carboplatin.
When combined to docetaxel, the clearance of carboplatin was about 50% higher than values previously reported for carboplatin monotherapy.
Meta carboplatin ingħata ma ’ docetaxel, it- tneħħija ta ’ carboplatin kienet madwar 50% ogħla mill- istimi irrapportati qabel għat- terapija b’ carboplatin waħdu.
Docetaxel pharmacokinetics in the presence of prednisone was studied in patients with metastatic prostate cancer.
9 Il- komportament farmakokinetinu ta ’ Docetaxel fil- preżenza ta ’ prednisone kien studjat f’ pazjenti b’ kanċer metastatiku tal- prostata.
Docetaxel is metabolised by CYP3A4 and prednisone is known to induce CYP3A4.
Docetaxel huwa metaboliżżat minn CYP3A4 u l- prednisone huwa magħruf li jinduċi CYP3A4.
No statistically significant effect of prednisone on the pharmacokinetics of docetaxel was observed.
Ma kienx hemm effett statistikament sinifikanti ta ’ prednisone fuq il - komportament famakokinetiku ta ’ Docetaxel.
A drug interaction study performed in patients receiving ketoconazole and docetaxel showed that the clearance of docetaxel was reduced by half by ketoconazole, probably because the metabolism of docetaxel involves CYP3A4 as a major (single) metabolic pathway.
Docetexal għandu jingħata b’ kawtela f’ pazjenti li fl- istess ħin qegħdin jirċievu inibituri qawwijin ta ’ CYP3A4 (eż inibituri ta ’ protease bħal ritonavir, mediċini antifungali tat- tip azole bħal ketoconazole jew itraconazole). Studju ta ’ interazzjoni bejn il- mediċini magħmul f’ pazjenti li qegħdin jirċievu ketoconazole u docetaxel wera li t- tneħħija ta ’ docetaxel tnaqqas bin- nofs minħabba ketoconazole u dan probabbilment għaliex il- metaboliżmu ta ’ docetaxel jinvolvi lil CYP3A4 bħala l- mezz ewlieni (waħdieni) ta ’ metaboliżmu.
Reduced tolerance of docetaxel may occur, even at lower doses.
It- tollerabbilità ta ’ docetaxel tista ’ tonqos anki b’ dożi baxxi.
There is no information on the use of docetaxel in pregnant women.
M’ hemmx informazzjoni fuq l- użu ta ’ docetaxel f’ nisa tqal.
Docetaxel has been shown to be both embryotoxic and foetotoxic in rabbits and rats, and to reduce fertility in rats.
Docetaxel intwera li huwa tossiku kemm għall- embriju kif ukoll għall- fetu fil- fniek u l- firien, u li naqqas il- fertilità fil- firien.
As with other cytotoxic medicinal products, docetaxel may cause foetal harm when administered to pregnant women.
Bħal ma jiġri b’ prodotti mediċinali ċitotossiċi oħrajn, docetaxel jista ’ jikkawża ħsara lill- fetu meta jingħata lin- nisa waqt it- tqala.
Therefore, docetaxel must not be used during pregnancy.
Għalhekk, docetaxel m’ għandux jintuża waqt it- tqala.
Women of childbearing age receiving docetaxel should be advised to avoid becoming pregnant, and to inform the treating physician immediately should this occur.
Nisa f’ età li jista ’ jkollhom it- tfal u li qegħdin jirċievu docetaxel għandhom jingħataw parir biex jevitaw li joħorġu tqal, u biex jinformaw lit- tabib kuranti tagħhom immedjatament jekk dan iseħħ.
Docetaxel is a lipophilic substance but it is not known whether it is excreted in human milk.
Docetaxel huwa sustanza lipofilika iżda mhux magħruf jekk joħroġx għal ġol- ħalib tal- mara.
Consequently, because of the potential for adverse reactions in nursing infants, breast feeding must be discontinued for the duration of docetaxel therapy.
Imħabba dan, peress li jeżisti l- potenzjal li jista ’ jkun hemm effetti mhux mixtieqa fit- trabi li qegħdin ikunu mreddgħin, it- treddigħ għandu jitwaqqaf waqt iż- żmien tat- terapija b’ docetaxel.
The adverse reactions considered to be possibly or probably related to the administration of docetaxel have been obtained in: • 1312 and 121 patients who received 100 mg/ m² and 75 mg/ m² of docetaxel as a single agent respectively. • 258 patients who received docetaxel in combination with doxorubicin. • 406 patients who received docetaxel in combination with cisplatin. • 92 patients treated with docetaxel in combination with trastuzumab.
Ir- reazzjonijiet avversi li jitqiesu possibbilment jew probabilment relatati mat- teħid ta ’ docetaxel inġabru minn:
9 • 255 patients who received docetaxel in combination with capecitabine. • 332 patients who received docetaxel in combination with prednisone or prednisolone (clinically important treatment related adverse events are presented). • 744 patients who received docetaxel in combination with doxorubicin and cyclophosphamide (clinically important treatment related adverse events are presented). • 300 gastric adenocarcinoma patients (221 patients in the phase III part of the study and 79 patients in the phase II part) who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically important treatment related adverse events are presented). • 174 and 251 head and neck cancer patients who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically important treatment related adverse events are presented).
1312 u 121 pazjent li ħadu 100 mg/ m2 u 75 mg/ m2 ta ’ docetaxel bħala sustanza waħedha, • rispettivament. • 258 pazjent li ħadu docetaxel flimkien ma ’ doxorubicin. • 406 pazjent li ħadu docetaxel flimkien ma ’ cisplatin. • 92 pazjent ittrattati b’ docetaxel flimkien ma ’ trastuzumab. • 255 pazjent li ħadu docetaxel flimkien ma ’ capecitabine. • 332 pazjent li ħadu docetaxel flimkien ma ’ prednisone jew prednisolone (effetti avversi klinikament importanti relatati mat- trattament huma irrapportati). • 744 pazjent li ħadu docetaxel flimkien ma ’ doxorubicin u cyclophosphamide (effetti avversi klinikament importanti relatati mat- trattament huma irrapportati). • 300 pazjent b’ adenokarċinoma ta ’ l- istonku (221 pazjent fil- fażi III ta ’ l- istudju u 79 pazjent fil - fażi II), li ħadu docetaxel flimkien ma ’ cisplatin u 5- fluorouracil (effetti avversi klinikament importanti relatati mat- trattament huma irrapportati). • 174 u 251pazjent b’ kanċer tar- ras u ta ’ l- għonq li ħadu docetaxel flimkien ma’ cisplatin u 5 - fluorouracil (effetti avversi klinikament importanti relatati mat- trattament huma irrapportati).
These reactions were described using the NCI Common Toxicity Criteria (grade 3 = G3; grade 3-4 = G3/ 4; grade 4 = G4) and the COSTART terms.
Dawn ir- reazzjonijiet kienu deskritti bl- użu ta ’ NCI Kriterji ta ’ Tossiċità Komuni (grad 3 = G3; grad 3- 4 = G3/ 4; grad 4=G4) u t- terminoloġija COSTART.
Frequencies are defined as: 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).
Il- frekwenzi huma kif spjegat: komuni ħafna (≥ 1/ 10); komuni (≥ 1/ 100, < 1/ 10); mhux komuni (≥ 1/ 1000, < 1/ 100); rari (≥ 1/ 10, 000, < 1/ 1, 000); rari ħafna (< 1/ 10, 000).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżla skond is- serjeta tagħhom, bl- aktar serji jitniżżlu l- ewwel.
The most commonly reported adverse reactions of docetaxel alone are: neutropenia (which was reversible and not cumulative; the median day to nadir was 7 days and the median duration of severe neutropenia (< 500 cells/ mm3) was 7 days), anemia, alopecia, nausea, vomiting, stomatitis, diarrhea and asthenia.
10 Ir- reazzjonijiet avversi l- aktar komunement irrapportati ta ’ docetaxel innifsu huma: newtropenija (li kienet riversibbli u mhux kumulattiva: il- jum medjan biex jintlaħaq in- nadir kien ta ’ 7 ijiem u ż- żmien medju ta ’ dewmien tan- newtropenija severa (< 500 ċelluli/ mm3) kien ta ’ 7 ijiem), anemija, alopeċja, tqalligħ, rimettar, stomatite, dijarea u astenja.
The severity of adverse events of docetaxel may be increased when docetaxel is given in combination with other chemotherapeutic agents.
Is severità tal- ġrajjiet avversi ta ’ docetaxel tista ’ tiżdied meta docetaxel jingħata flimkien ma ’ sustanzi kimoterapewtiċi oħra.
For combination with trastuzumab, adverse events (all grades) reported in ≥ 10% are displayed.
Meta jintuża flimkien ma ’ trastuzumab, il- ġrajjiet avversi (il- gradi kollha) irrapportati f ’ > 10% qed jingħataw.
23%) in the trastuzumab combination arm compared to docetaxel monotherapy.
Kien hemm żieda fl- inċidenza ta ’ SAEs (40% kontra 31%) u Grad 4 AEs (34% kontra 23%) fil- fergħa ta ’ dawk li ħadu iż- żewġ sustanzi meta mqabbla ma ’ dik li ħadu docetaxel waħdu.
For combination with capecitabine, the most frequent treatment-related undesirable effects (≥ 5%) reported in a phase III trial in breast cancer patients failing anthracycline treatment are presented (see capecitabine summary of product characteristics).
Meta jintuża flimkien ma ’ capecitabine, l- effetti mhux mixtieqa l- aktar komuni assoċjati mat - trattament (≥ 5%) rapportati fil- fażi III ta ’ l- istudji fil- pazjenti li kellhom kanċer tas- sider, meta l- kura b’ anthracycline falliet, qed jingħataw (ara s- sommarju tal- karatteristiċi tal- prodott ta ’ capecitabine).
The following adverse reactions are frequently observed with docetaxel:
Ir- reazzjonijiet avversi li jmissu huma ikkaġunati spiss b’ docetaxel:
Nervous system disorders
Disturbi fis- sistema nervuża:
The development of severe peripheral neurotoxicity requires a reduction of dose (see sections 4.2 and 4.4).
L- iżvilupp ta’ newrotossiċità periferika u severa jirrikjedi tnaqqis fid- doża (ara sezzjonijiet 4. 2 u 4. 4).
Mild to moderate neuro-sensory signs are characterised by paresthesia, dysesthesia or pain including burning.
Effetti newro- sensorji ħfief għal dawk moderati huma ikkaratteriżżati minn parasteżija, disteżija jew l - uġigħ inkluż il- ħruq.
Neuro-motor events are mainly characterised by weakness.
Effetti fuq is– sistema nervuża li tikkontrolla l- movimenti huma prinċipalment ikkaratteriżżati minn dgħjufija.
Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda:
Reversible cutaneous reactions have been observed and were generally considered as mild to moderate.
Reazzjonijiet tal- ġilda riversibbli kienu innotati u kienu ġeneralment meqjusa bħala ħfief għal dawk moderati.
Eruptions generally occurred within one week after the docetaxel infusion.
Ir- reazzjonijiet kienu ikkaratteriżżati minn raxxijiet, li jinkludu msiemer fil - ġilda lokaliżżati prinċipalment fis- saqajn u l- idejn (u li jinkludi is- sindrome ta ’ l- Id u s- Sieq severa), iżda ukoll fuq id - dirgħajn, wiċċ u t- toraċi, u ta ’ spiss assoċjati mal- ħakk. l - imsiemer fil - ġilda x’ aktarx tfaċċaw fi żmien ġimgħa wara l- infużjoni ta’ docetaxel.
Less frequently, severe symptoms such as eruptions followed by desquamation which rarely lead to interruption or discontinuation of docetaxel treatment were reported (see sections 4.2 and 4.4).
Anqas spiss, sintomi qawwija bħal raxxijiet segwiti minn msiemer tal- ġilda li jitqaxxru kienu innotati li rarament wassal għal interruzjoni jew waqfien fit - trattament ta ’ docetaxel (ara sezzjonijiet 4. 2 u 4. 4).
Severe nail disorders are characterised by hypo- or hyperpigmentation and sometimes pain and onycholysis.
Mard sever tad- dwiefer huma ikkaratteriżżati minn ipo - jew iperpigmentazzjoni b’ xi drabi uġigħ u onikoliżi.
General disorders and administration site conditions
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata:
Infusion site reactions were generally mild and consisted of hyper pigmentation, inflammation, redness or dryness of the skin, phlebitis or extravasation and swelling of the vein.
Reazzjonijiet tas- sit ta ’ l- infużjoni kienu ġeneralment ħfief u jikkonsistu b’ iperpigmentazzjoni zejda, infjammazzjoni, ħmura u ġilda xotta, flebite jew nefħa u ħruġ ta ’ likwidu mill- vina.
The peripheral oedema usually starts at the lower
Iz- żamm tal- fluwidu jinkludi ġrajjiet bħan- nefħa tal- periferiji u anqas komuni l- effużjoni tal- plewra., tal- perikardju, axxitekif ukoll żieda fil- piż.
10 extremities and may become generalised with a weight gain of 3 kg or more.
In- nefħa periferika x’ aktarx tibda fl- estremitajiet t’ isfel u tista ’ issir ġeneraliżżata b’ żieda fil- piż ta ’ 3 kg jew aktar.
Fluid retention is cumulative in incidence and severity (see section 4.4).
Iż- żamm tal- fluwidu jista ’ jkun kumulattiv fl- inċidenza u s- severità (ara sezzjoni 4. 4).
Immune system disorders
Disturbi fis- sistema immuni:
Hypersensitivity reactions have generally occurred within a few minutes following the start of the infusion of docetaxel and were usually mild to moderate.
Reazzjonijiet ta ’ sensittività eċċessiva ġeneralment ġraw fi żmien ftit minuti mill- bidu ta ’ l- infużjoni ta ’ docetaxel u li soltu kienu ħfief għal moderati.
The most frequently reported symptoms were flushing, rash with or without pruritus, chest tightness, back pain, dyspnoea and fever or chills.
Is- sintomi l- aktar frekwentement rapportati kienu l - fwawar, raxx bil- ħakk jew mingħajru, nifs tqil, uġigħ tad- dahar, qtugħ ta ’ nifs u deni dovut għal mediċini, jew tkexix ta ’ bard.
Severe reactions were characterised by hypotension and/ or bronchospasm or generalized rash/ erythema (see section 4.4).
Reazzjonijiet qawwija kienu ikkaratteriżżati minn pressjoni baxxa u/ jew spasmu tal- bronki bi qtugħ ta ’ nifs jew raxx/ ħmura ġeneraliżżat( a) (ara sezzjoni 4. 4).
Docetaxel Winthrop 100 mg/ m² single agent
11 Docetaxel Winthrop 100 mg/ m2 bħala sustanza użata waħedha:
MedDRA System Organ classes Investigations
Database MedDRA Investigazzjonijiet
Very common adverse Common adverse reactions reactions ≥ 10% of patients ≥ 1 to < 10% of patients G3/ 4 Blood bilirubin increased (< 5%); G3/ 4 Blood alkaline phosphatase increased (< 4%); G3/ 4 AST increased (< 3%); G3/ 4 ALT increased (< 2%)
> 1 sa < 10% tal - pazjenti G3/ 4 Żieda fil - bilirubina fid- demm (< 5%); G3/ 4 Żieda fl - alkaline phosphatase fid- demm (< 4%); G3/ 4 Żieda fl- AST (< 3%); G3/ 4 Żieda fl- ALT (< 2%)
Uncommon adverse reactions ≥ 0.1 to < 1% of patients
< 1% tal- pazjenti
Arrhythmia (G3/ 4:
Arritmija (G3/ 4:
0.7%)
0. 7%)
Cardiac failure
Insuffiċjenza tal- qalb
Blood and lymphatic system disorders
Disturbi tad- demm u tas - sistema limfatika
Neutropenia (G4:
Newtropenija (G4:
76.4%); 0.2%) Anaemia (G3/ 4:
76. 4%); Anemija (G3/ 4:
8.9%); Febrile neutropenia
8. 9%); Newtropenija bid- deni
Peripheral sensory neuropathy (G3:
Newropatija periferika tas - sensazzjoni (G3:
4.1%); Peripheral motor neuropathy (G3/ 4:
4. 1%); Newropatija periferika tal - movimenti (G3/ 4:
4%); Dysgeusia (severe:
4%); Disgewżja( severa:
0.07%)
0. 07%)
Dyspnoea (severe:
Qtugħ ta ’ nifs (sever:
2.7%)
2. 7%)
Constipation (severe:
5. 3%); Dijarea (G3/ 4:
5.3%); 0.2%); Diarrhoea (G3/ 4:
4%); Tqalligħ (G3/ 4:
4%); (severe:
(severa: 0. 2%); Uġigħ ta ’ żaqq (sever:
1%); Vomiting (G3/ 4:
1%); emoraġija gastro - intestinali (severa:
0.3%)
0. 3%)
0.4%)
0. 4%).
Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u tat - tessuti ta ’ taħt il- ġilda
Alopecia; Skin reaction (G3/ 4:
Alopeċja; Reazzjonijiet tal- ġilda (G3/ 4:
5.9%); Nail disorders (severe:
5. 9%); Mard tad- dwiefer (sever:
2.6%)
2. 6%)
Musculoskeletal and connective tissue disorders
Disturbi muskolu - skeletrali, tal- connective tissue
Myalgia (severe:
Majalġja (severa:
1.4%) Arthralgia
1. 4%)
Metabolism and
Artralġja
Infections (G3/ 4:
Infezzjonijiet (G3/ 4:
5.7%; Infection associated including sepsis and with G4 neutropenia pneumonia, fatal in (G3/ 4:
Infezzjoni assoċjata ma ’ G4 newtropenija (G3/ 4:
4.6%) 1.7%)
4. 6%)
Hypotension; Hypertension; Haemorrhage
Pressjoni baxxa; Pressjoni għolja; Emoraġija Reazzjoni fis- sit ta ’
Fluid retention (severe:
Żamm tal- fluwidu (sever:
Infusion site reaction; 6.5%); Non-cardiac chest pain Asthenia (severe:
l- infuzjoni;
(severe:
Astenja (severa:
0.4%) 11.2%); Pain
11. 2%); Uġigħ
Hypersensitivity (G3/ 4:
Sensittività eċċessiva (G3/ 4:
5.3%)
5. 3%)
Blood and lymphatic system disorders Rare: bleeding episodes associated with grade 3/ 4 thrombocytopenia.
Rari: ġrajjiet emorraġiċi assocjati ma ’ grad 3/ 4 ta ’ tromboċitopenija
Nervous system disorders Reversibility data are available among 35.3% of patients who developed neurotoxicity following docetaxel treatment at 100 mg/ m² as single agent.
Data ta ’ riversibbiltà hija disponibbli f’ 35. 3% tal- pazjenti li żviluppaw newrotossiċità wara t - trattament b’ docetaxel waħdu f’ doża ta ’ 100 mg/ m².
The events were spontaneously reversible within 3 months.
Il- ġrajjiet imsemmija kienu riversibbli waħedhom fi żmien 3 xhur.
Skin and subcutaneous tissue disorders Very rare: one case of alopecia non-reversible at the end of the study.
Rari ħafna: każ wieħed ta ’ alopeċja mhux riversibbli fit- tmiem ta ’ l- istudju.
73% of the cutaneous reactions were reversible within 21 days.
73% tar- reazzjonijiet tal - ġilda kienu riversibbli fi żmien 21 jum.
General disorders and administration site conditions The median cumulative dose to treatment discontinuation was more than 1,000 mg/ m2 and the median time to fluid retention reversibility was 16.4 weeks (range 0 to 42 weeks).
Id- doża medjana kumulattiva għall- waqfien tat- trattament kienet aktar minn 1, 000 mg/ m2, u z- żmien medjan għar- riversibbilità taż- żamm tal- fluwidu kien ta ’ 16. 4 ġimghat (medda 0 sa 42 ġimghat).
The onset of moderate and severe retention is delayed (median cumulative dose:
Il - bidu taż- żamm moderat u sever ittardja (doża kumulattiva medjana:
818.9 mg/ m2) in patients with premedication compared with patients without premedication (median cumulative dose:
818. 9 mg/ m2) f’ pazjenti li ħadu l - premedikazzjoni, meta mqabbel ma ’ dawk li ma ħadux il- premedikazzjoni (doża kumulattiva medjana:
489.7 mg/ m2); however, it has been reported in some patients during the early courses of therapy.
Madankollu, dan kien irrapportat f’ xi pazjenti waqt il- korsijiet bikrija tat- terapija.
12 Docetaxel Winthrop 75 mg/ m² single agent
Docetaxel Winthrop 75 mg/ m² bħala sustanza użata waħedha:
MedDRA System Organ classes
Sistema tal- Klassifika tal -- Organi fid- Database
Very common adverse reactions ≥ 10% of patients
Reazzjonijiet avversi komuni > 1 sa < 10% tal- pazjenti
Common adverse reactions ≥ 1 to < 10% of patients
≥ 10% tal- pazjenti
G3/ 4 Blood bilirubin increased (< 2%)
G3/ 4 Żieda fil- bilirubin fid- demm (< 2%)
Arrhythmia (no severe)
Arritmija (mhux severa) Newtropenija bid- deni
54.2%); Anaemia (G3/ 4:
54. 2%); Anemija (G3/ 4:
10.8%); Thrombocytopenia (G4:
10. 8%); Tromboċitopenija (G4:
1.7%)
1. 7%)
Peripheral sensory neuropathy (G3/ 4:
Newropatija periferika tas - sensazzjoni (G3/ 4:
0.8%)
0. 8%);
Peripheral motor neuropathy (G3/ 4:
Newropatija periferika tal - movimenti (G3/ 4:
2.5%)
2. 5%); Stitikezza
Nausea (G3/ 4:
Tqalligħ (G3/ 4:
3.3%); Stomatitis (G3/ 4:
3. 3%); Stomatite (G3/ 4:
1.7%); Vomiting (G3/ 4:
1. 7%); Rimettar (G3/ 4:
0.8%); Diarrhea (G3/ 4:
0. 8%) Dijarea (G3/ 4:
1.7%)
1. 7%);
Skin and subcutaneous tissue disorders Musculoskeletal and connective tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Nail disorders (severe:
Mard tad- dwiefer (sever:
0.8%) Myalgia
Majalġja
Metabolism and nutrition disorders
Disturbi fil- metaboliżmu u n - nutrizzjoni
Infections and infestations Vascular disorders General disorders and administration site conditions
Disturbi vaskulari Infezzjonijiet u infestazzjonijiet
5%) Asthenia (severe:
Astenja (severa:
12.4%); Fluid retention (severe:
12. 4%); Żamm tal- fluwidu (sever:
0.8%); Pain
0. 8%) 13
Hypotension
Reazzjonijiet avversi komuni > 1 sa < 10% tal- pazjenti
Immune system disorders
jingħata Disturbi fis- sistema immuni
Hypersensitivity (no severe)
Sensittività eċċessiva (mhux severa)
13 Docetaxel Winthrop 75 mg/ m² in combination with doxorubicin
Docetaxel Winthrop 75 mg/ m² użat flimkien ma ’ doxorubicin:
MedDRA System Organ classes
Sistema tal- Klassifika tal- Organi fid- Database MedDRA
Very common adverse Common adverse reactions reactions ≥ 10% of patients ≥ 1 to < 10% of patients
Reazzjonijiet avversi komuni ħafna ≥ 10% tal- pazjenti
Uncommon adverse reactions ≥ 0.1 to < 1% of patients
Reazzjonijiet avversi komuni > 1 to < 10% tal -
G3/ 4 Blood bilirubin increased (< 2.5%); G3/ 4 Blood alkaline phosphatase increased (< 2.5%)
G3/ 4 Żieda fil- bilirubin fid- demm (< 2. 5%);
G3/ 4 AST increased (< 1%); G3/ 4 ALT increased (< 1%)
G3/ 4 Żieda fl- AST (< 1%);
Cardiac disorders
G3/ 4 Żieda fl- alkaline G3/ 4 Żieda fl- ALT (< phosphatase fid- demm 1%) (< 2. 5%) Disturbi fil- qalb
Cardiac failure; Arrhythmia (no severe)
Insuffiċjenza tal- qalb; Arritmija (mhux severa)
91.7%); Anaemia (G3/ 4:
91. 7%); Anemija (G3/ 4:
9.4%); Febrile neutropenia; Thrombocytopenia (G4:
9. 4%); Newtropenija bid- deni; Tromboċitopenija (G4:
0.8%)
0. 8%)
Nervous system disorders
Disturbi fis- sistema nervuża Disturbi gastro- intestinali
Peripheral sensory Peripheral motor neuropathy (G3:
Newropatija periferika tas- sensazzjoni (G3:
0.4%) neuropathy (G3/ 4:
0. 4%) Tqalligħ (G3/ 4:
Gastrointestinal disorders
7. 8%); Dijarea (G3/ 4:
Nausea (G3/ 4:
6. 2%); Rimettar (G3/ 4:
5%); Stomatitis (G3/ 4:
5%); Stitikezza
7.8%); Diarrhoea (G3/ 4:
Newropatija periferika tal- movimenti (G3/ 4:
6.2%); Vomiting (G3/ 4:
0. 4%)
Alopecia; Nail disorders (severe:
Alopeċja; Mard tad- dwiefer (sever:
0.4%); Skin reaction (no severe)
0. 4%); Reazzjoni tal- ġilda (mhux severa)
Musculoskeletal and connective tissue disorders
Disturbi muskolu - skeletrali u tal- connective tissue
Infection (G3/ 4:
Infezzjoni (G3/ 4:
7.8%)
7. 8%)
Vascular disorders General disorders and administration site conditions
Reazzjoni fis- sit ta ’ l -
Asthenia (severe:
Astenja (severa:
1.2%); Pain
8. 1%);
Hypotension
infuzjoni
14 Docetaxel Winthrop 75 mg/ m² in combination with cisplatin
14 Docetaxel Winthrop 75 mg/ m² użat flimkien ma ’ cisplatin:
MedDRA System Organ classes
Sistema tal- Klassifika tal - Organi fid- Database MedDRA
Very common adverse reactions ≥ 10% of patients
Reazzjonijiet Avversi komuni ħafna ≥ 10% tal- pazjenti
Common adverse reactions ≥ 1 to < 10% of patients
Reazzjonijiet Avversi komuni > 1 to < 10% tal- pazjenti
Uncommon adverse reactions ≥ 0.1 to < 1% of patients
Reazzjonijiet Avversi mhux komuni > 0. 1 to < 1% tal - pazjenti G3/ 4 Żieda fl- AST
G3/ 4 Blood bilirubin increased (2.1%); G3/ 4 ALT increased (1.3%)
G3/ 4 Żieda fil- bilirubin fid- demm (2. 1%); G3/ 4 Żieda fl- ALT (1. 3%)
G3/ 4 AST increased (0.5%); G3/ 4 Blood alkaline phosphatase increased (0.3%)
(0. 5%); G3/ 4 Żieda fl- alkaline phosphatase fid- demm (0. 3%)
0.7%)
0. 7%) Newtropenija bid- deni
Anaemia (G3/ 4:
51. 5%); Anemija (G3/ 4:
6.9%); Thrombocytopenia (G4:
6. 9%); Tromboċitopenija (G4:
0.5%) Nervous system disorders
0. 5%)
Peripheral sensory neuropathy (G3:
Disturbi fis- sistema nervuża Newropatija periferika tas - sensazzjoni (G3:
2%)
3. 7%); Newropatija periferika tal - movimenti (G3/ 4:
Gastrointestinal disorders
2%) Stitikezza Disturbi gastro- intestinali
9.6%); Vomiting (G3/ 4:
9. 6%); Rimettar (G3/ 4:
7.6%); Diarrhoea (G3/ 4:
7. 6%); Dijarea (G3/ 4:
6.4%); Stomatitis (G3/ 4:
6. 4%); Stomatite (G3/ 4:
0.7%); Skin reaction (G3/ 4:
0. 7%); Reazzjoni tal- ġilda (G3/ 4:
0.2%)
0. 2%)
0.5%)
Disturbi muskolu- skeletrali u Majalġja (severa:
Metabolism and nutrition disorders
0. 5%) tal- connective tissue Disturbi fil- metaboliżmu u n - Anoreksja nutrizzjoni Infezzjonijiet u infestazzjonijiet
5.7%)
5. 7%)
Hypotension (G3/ 4:
Pressjoni baxxa (G3/ 4:
0.7%)
0. 7%) Reazzjoni fis- sit ta ’ l -
General disorders and administration site
Disturbi ġenerali u
9.9%);
9. 9%);
Infusion site reaction; Pain
infuzjoni;
conditions
kondizzjonijiet ta ’ mnejn
0.7%); Fever (G3/ 4:
0. 7%); Deni (G3/ 4:
2.5%)
2. 5%)
15 Docetaxel Winthrop 100 mg/ m² in combination with trastuzumab
Docetaxel Winthrop 100 mg/ m² użat flimkien ma ’ trastuzumab:
Very common adverse reactions ≥ 10% of patients
Reazzjonijiet Avversi komuni hafna ≥ 10% tal- pazjenti
Common adverse reactions ≥ 1 to < 10% of patients
Reazzjonijiet Avversi Komuni > 1% sa < 10% tal- pazjenti
Investigations Cardiac disorders Blood and lymphatic system disorders
Investigazzjonijiet Disturbi fil- qalb Disturbi tad- demm u tas- sistema limfatika
Weight increased Neutropenia (G3/ 4:
Żieda fil- piż Newtropenija (G3/ 4:
32%); Febrile neutropenia (includes neutropenia associated with fever and antibiotic use) or neutropenic sepsis
32%); Newtropenija bid- deni (tinkludi n - newtropenija assoċjata mad- deni u l- użu ta ’ l- antibijotiċi) jew newtropenija bis - sepsis
Nervous system disorders
15 Sistema tal- Klassifika tal - Organi fid- Database MedDRA
Paresthesia; Headache; Dysgeusia; Hypoaesthesia
Reazzjonijiet Avversi Komuni > 1% sa < 10% tal- pazjenti
Eye disorders
Disturbi fis- sistema nervuża
Lacrimation increased; Conjunctivitis
Parasteżija; Ugigħ ta ’ ras; Disgewżja; Ipoestesija
Respiratory, thoracic and mediastinal disorders
Disturbi fl- għajnejn Disturbi repiratorji, toraċiċi u medjastinali
Epistaxis; Pharyngolaryngeal pain; Nasopharyngitis; Dyspnoea; Cough; Rhinorrhoea
Tidmigħ miżjud; Konġuntivite Fġir l- imnieħer; Uġigh fil farinġi u l - larinġi; Farinġite tal- parti nażali; Qtugħ ta ’ nifs; Sogħla; Tnixxija mill- imnieħer
Nausea; Diarrhoea; Vomiting; Constipation; Stomatitis; Dyspepsia; Abdominal pain
Tqalligħ; Dijarea; Rimettar; Stitikezza; Stomatite; Dispepsja; Uġigħ addominali
Skin and subcutaneous tissue disorders Musculoskeletal and connective tissue disorders Metabolism and nutrition disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Alopecia; Erythema; Rash; Nail disorders Myalgia; Arthralgia; Pain in extremity; Bone pain; Back pain Anorexia
Alopeċja; Eritema; Raxx; Mard tad - dwiefer
Vascular disorders
Disturbi muskolu- skeletrali u tal - Majalġja; Artralġja; Uġigħ fl- estremitajiet; Uġigħ fl- għadam; Uġigħ tad- dahar connective tissue Disturbi fil- metaboliżmu u n - nutrizzjoni
Lymphoedema
Anoreksja
General disorders and administration site conditions
Disturbi vaskulari Disturbi ġenerali u
Asthenia; Oedema peripheral; Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills
Edima limfatika Astenja; Edima periferika; Deni; Għejja;
Psychiatric disorders
kondizzjonijiet ta ’ mnejn jingħata Infjammazzjoni tal- mukoża; Uġigħ; Mard bħall- influwenza; Uġigħ fis- sider; Riħ bid - deni Disturbi psikjatriċi
Cardiac disorders
Disturbi fil -- qalb:
Symptomatic cardiac failure was reported in 2.2% of the patients who received docetaxel plus trastuzumab compared to 0% of patients given docetaxel alone.
Insuffiċjenza tal- qalb sintomatika kienet irrapportata f’ 2. 2% tal- pazjenti li ħadu Docetaxel Winthrop flimkien ma ’ trastuzumab meta mqabbel ma ’ 0% tal- pazjenti li ngħataw Docetaxel Winthrop wahdu.
In the docetaxel plus trastuzumab arm, 64% had received a prior anthracycline as adjuvant therapy compared with 55% in the docetaxel arm alone.
Fil- qasam ta ’ l- istudji fejn Docetaxel Winthrop intuża flimkien ma ’ trastuzumab, 64% kienu ħadu qabel anthracycline bħala terapija miżjuda, meta mqabbel ma ’ 55% tal- fergħa ta ’ docetaxel biss.
Blood and lymphatic system disorders Very common:
Disturbi tad- demm u tas- sistema limfatika:
Haematological toxicity was increased in patients receiving trastuzumab and docetaxel, compared with docetaxel alone (32% grade 3/ 4 neutropenia versus 22%, using NCI-CTC criteria).
Tossiċità ematoloġika żdiedet f’ pazjenti li ħadu trastuzumab u docetaxel, meta mqabbla ma ’ docetaxel waħdu (32% grad 3/ 4 newtropenija kontra 22%, meta ntużaw il- kriterji NCI - CTC).
Note that this is likely to be an underestimate since docetaxel alone at a dose of 100 mg/ m2 is known to result in neutropenia in 97% of patients, 76% grade 4, based on nadir blood counts.
Innota li din hija probabbli stima baxxa għax docetaxel waħdu f’ doża ta’ 100 mg/ m2 hu magħruf li jġib in- newtropenija f’ 97% tal- pazjenti, 76% fi grad 4, meta ibbażata fuq in- nadir ta ’ l- għadd taċ - ċelluli fid- demm.
The incidence of febrile neutropenia/ neutropenic sepsis was also increased in patients treated with Herceptin plus docetaxel (23% versus 17% for patients treated with docetaxel alone).
L- inċidenza tan- newtropenija bid- deni/ tan- newtropenija bis- sepsis kienet żdiedet ukoll f’ pazjenti ittrattati b’ Herceptin flimkien ma ’ docetaxel (23% kontra 17% għal pazjenti ittrattati b’ docetaxel biss).
16 Docetaxel Winthrop 75 mg/ m² in combination with capecitabine
Docetaxel Winthrop 75 mg/ m² użat flimkien ma ’ capecitabine:
MedDRA System Organ classes
Sistema tal- Klassifika tal- Organi fid - Database MedDRA
Weight decreased; G3/ 4 Blood bilirubin increased (9%)
Tnaqqis fil- piż; G3/ 4 Żieda fil- bilirubin fid - demm (9%)
Neutropenia (G3/ 4:
Newtropenija (G3/ 4:
63%); Anaemia (G3/ 4:
63%); Anemija (G3/ 4:
Thrombocytopenia (G3/ 4:
Tromboċitopenija (G3/ 4:
Dysgeusia (G3/ 4: < 1%); Paraesthesia (G3/ 4: < 1%)
Disgewżja (G3/ 4: < 1%); Parasteżija (G3/ 4: < 1%)
Dizziness; Headache (G3/ 4: < 1%); Neuropathy peripheral
Sturdament; Uġigħ ta ’ ras (G3/ 4: < 1%); Newropatija periferika
Lacrimation increased
Tidmigħ miżjud
Pharyngolaryngeal pain (G3/ 4:
Uġigh fil- farinġi u l- larinġi (G3/ 4:
Dyspnoea (G3/ 4:
Qtugħ ta ’ nifs (G3/ 4:
1%); Cough (G3/ 4: < 1%); Epistaxis (G3/ 4: < 1%)
1%); Sogħla (G3/ 4: < 1%); Fġir l- imnieħer (G3/ 4: < 1%)
18%); Diarrhoea (G3/ 4:
18%); Dijarrea (G3/ 4:
14%); Nausea (G3/ 4:
14%); Tqalligħ (G3/ 4:
6%); Vomiting (G3/ 4:
6%); Rimettar (G3/ 4:
4%); Constipation (G3/ 4:
4%); Stitikezza (G3/ 4:
1%); Abdominal pain (G3/ 4:
1%); Uġigħ ta ’ żaqq (G3/ 4:
2%); Dyspepsia
2%); Dispepsja
Abdominal pain upper; Dry mouth
Ħalq xott Dermatite;
Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il -
Hand-foot syndrome (G3/ 4:
(G3/ 4:
24%); Alopecia (G3/ 4:
24%) Alopeċja (G3/ 4:
6%); Nail disorders (G3/ 4:
6%); Mard tad- dwiefer (G3/ 4:
Dermatitis; Rash erythematous (G3/ 4: < 1%); Nail discolouration; Onycholysis (G3/ 4:
Bidla fil- kulur tad- dwiefer; onikolizi( G3/ 4:
Musculoskeletal and connective tissue disorders Metabolism and nutrition disorders Infections and infestations
Disturbi muskolu- skeletral u tal - connective tissue
Myalgia (G3/ 4:
Majalġja (G3/ 4:
2%); Arthralgia (G3/ 4:
2%); Artralġja (G3/ 4:
1%) Anorexia (G3/ 4:
Anoreksja( G3/ 4:
1%); Decreased appetite
1%); Tnaqqis fl- aptit
1%) Dehydration (G3/ 4:
2%);
2%) Oral candidiasis (G3/ 4: < 1%)
Candidiasis orali( G3/ 4: < 1%) Letarġija;
General disorders and administration site conditions
Disturbi ġenerali u kondizzjonijiet ta ’
Asthenia (G3/ 4:
Astenja (G3/ 4: