qanastek/EMEA-V3 huggingface dataset:
The effectiveness of Diractin was studied in one main study involving 866 patients with osteoarthritis of the knee.
L- effikaċja ta ’ Diractin ġiet studjata fi studju wieħed prinċipali li jinvolvi 866 pazjent b’ osteoartrite tal- irkoppa.
The study compared the effectiveness of three different doses of Diractin (25 mg, 50 mg and 100 mg twice a day) with that of placebo (a dummy treatment).
L- istudju qabbel l- effikaċja ta ’ tliet dożi differenti ta ’ Diractin (25 mg, 50 mg u 100 mg darbtejn kuljum) ma ’ dak ta ’ plaċebo (kura finta).
The main measure of effectiveness was the change in the severity of pain after 12 weeks of treatment.
Il- miżura ewlenija tal- effikaċja kienet il- bidla fis- severità tal- uġigħ wara 12- il ġimgħa ta ’ kura.
How far into the evaluation was the application when it was withdrawn?
Sa fejn kienet waslet l- evalwazzjoni tal- applikazzjoni qabel ma din ġiet irtirata?
The application was at day 181 when the company withdrew.
L- applikazzjoni kienet f’ jum 181 meta l- kumpanija rtiratha.
After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Wara li s- CHMP ivvaluta t- tweġibiet mill - kumpanija għal lista ta ’ mistoqsijiet, kien għad hemm xi kwistjonijiet pendenti mhux riżolti.
The CHMP normally takes up to 210 days to evaluate a new application.
Is- CHMP normalment jieħu sa 210 ġranet sabiex jevalwa applikazzjoni ġdida.
Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Fuq il- bażi tar- reviżjoni tad- dokumentazzjoni inizjali, is- CHMP iħejji lista ta 'mistoqsijiet fil- jum 120, li mbagħad tintbagħat lill- kumpanija.
Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Ladarba l- kumpanija tkun ippreżentat it- tweġibiet tagħha għall- mistoqsijiet imressqa, is- CHMP jirrevedihom u jista ’, qabel ma jagħti opinjoni, jitlob għal xi mistoqsijiet oħra fil- jum 180.
Following the CHMP’ s opinion, it usually takes around two months for the European Commission to grant a license.
Wara l- opinjoni tas- CHMP, normalment il- Kummissjoni Ewropea ddum madwar xahrejn sakemm toħroġ l- awtorizzazzjoni.
Reproduction is authorised provided the source is acknowledged. could not have been approved for the treatment of the symptoms of inflammation and pain associated with osteoarthritis.
X' kienet ir- rakkomandazzjoni tas- CHMP dak iż- żmien?
What were the main concerns of the CHMP at that time?
X' kienet ir- rakkomandazzjoni tas- CHMP dak iż- żmien?
The CHMP was concerned that the effectiveness of Diractin had not been sufficiently demonstrated in the single main study: compared with placebo, Diractin did not reduce pain levels to an extent that would be relevant for patients.
Is- CHMP kien imħasseb li l- effikaċja ta ’ Diractin ma ntwerietx b’ mod suffiċjenti fl- istudju prinċipali waħdieni: meta mqabbel mal- plaċebo, Diractin ma naqqasx il- livelli ta ’ uġigħ sal- punt li jkun relevanti għall- pazjenti.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that any benefits of Diractin did not outweigh the identified risks.
Għalhekk, fi żmien l- irtirar, l- opinjoni tas- CHMP kienet li l- benefiċċju ta 'Diractin ma kienx jegħleb ir- riskji identifikati.
What were the reasons given by the company to withdraw the application?
X' kienu r- raġunijiet mogħtija mill- kumpanija għall- irtirar tal- applikazzjoni?
The letter from the company notifying the EMEA of the withdrawal of the application is available here.
L- ittra mill- kumpanija li tgħarraf lill- EMEA dwar l- irtirar tal- applikazzjoni tinsab hawn.
What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Diractin?
X’ inhuma l- konsegwenzi tal- irtirar għal dawk il- pazjenti li jkunu involuti fi provi kliniċi jew programmi ta ’ użu b’ kumpassjoni bl- użu ta ’ Diractin?
The company informed the CHMP that there are no consequences for patients currently included in clinical trials.
Il- kumpanija għarrfet lis- CHMP li ma kienx hemm konsegwenzi għall- pazjenti li jkunu għaddejjin minn provi kliniċi.
No compassionate use programmes with Diractin are being conducted.
Ma sar ebda programm ta ’ użu b’ kumpassjoni b’ Diractin.
If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Jekk inti qed tieħu sehem fi studju kliniku jew fi programm ta 'użu b’ kumpassjoni u trid iżjed tagħrif dwar it- trattament tiegħek, ikkuntattja lit- tabib li jkun qed jagħtik dan it- trattament.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Fih jinsab spjegat kif il- Kumitat għall- prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l- istudji mwettqa sabiex jagħti rakkomandazzjonijiet ta ’ kif din il- mediċina għandha tintuża.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk teħtieġ aktar informazzjoni dwar il- kundizzjoni medika jew it- trattament tiegħek, aqra l- Fuljett ta ’ Illustrazzjoni (li jagħmel ukoll parti mill- EPAR) jew ikkuntattja t- tabib jew l- ispiżjar tiegħek.
What is Docetaxel Winthrop?
X’ inhu Docetaxel Winthrop?
Docetaxel Winthrop is a concentrate and solvent to be made up into a solution for infusion (drip into a vein).
Docetaxel Winthrop fih konċentrat u kunjett li fih solvent li flimkien jiffurmaw soluzzjoni għall - infużjoni (dripp fil- vina).
It contains the active substance docetaxel.
Fih is- sustanza attiva docetaxel.
This medicine is the same as TAXOTERE, which is already authorised in the European Union.
Din il- mediċina hija simili ta ’ TAXOTERE, li hija diġà awtorizzata fl- Unjoni Europea.
The company that makes TAXOTERE has agreed that its scientific data can be used for Docetaxel Winthrop.
Il- kumpanija li tagħmel TAXOTERE qablet li l- informazzjoni xjentifika tagħha tista ’ tintuża għal Docetaxel Winthrop.
What is Docetaxel Winthrop used for?
Għal xiex jintuża Docetaxel Winthrop?
Docetaxel Winthrop is an anticancer medicine.
Docetaxel Winthrop huwa mediċina kontra l- kanċer.
It is used in: • breast cancer.
Jintuża fil- każijiet li jmiss: • kanċer tas- sider.
It can be used on its own after other treatments have failed.
Jista ’ jintuża waħdu wara li trattamenti oħra ma jkunux ħadmu.
It can also be used with other anticancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated. • non-small cell lung cancer.
Dan jiddependi mit- tip u l- istadju tal- kanċer fis- sider li jkun qed jiġi trattat. • kanċer tal- pulmun mhux ta ’ l- għamla ta ’ ċelluli żgħar.
It can also be used with cisplatin (another anticancer medicine) in patients who have not yet received any treatment for their cancer. • prostate cancer, when the cancer does not respond to hormonal treatment.
Jista ’ jintuża ma ’ cisplatin (mediċina oħra contra l- kanċer) f’ pazjenti li ma jkunux għadhom irċevew l- ebda trattament għall- kanċer tagħhom. • kanċer tal- prostata, meta l- kanċer ma jirrispondix għall- kura bl- orrmoni.
It is used with prednisone or prednisolone (anti-inflammatory medicines). • gastric adenocarcinoma (a type of stomach cancer) in patients who have not yet received any treatment for their cancer.
Jista ’ jintuża ma ’ prednisone jew prednisolone (mediċini anti- infjammatorji). • adenocarcinoma ta ’ l- istonku (tip ta ’ kanċer fl- istonku) f’ pazjenti li għadhom ma rċevew l - ebda trattament għall- kanċer tagħhom.
It is used with cisplatin and 5-fluorouracil (other anticancer medicines). • head and neck cancer in patients whose cancer is advanced.
Jista ’ jintuża ma ’ cisplatin u 5fluorouracil (mediċini oħra kontra l- kanċer). • kanċer tar- ras u ta ’ l- għonq f’ pazjenti li għandhom kanċer avvanzat.
It is used with cisplatin and 5-fluorouracil.
Jista ’ jintuża ma ’ cisplatin u 5fluorouracil.
See the Summary of Product Characteristics, also part of the EPAR, for full details.
Ara s- Sommarju tal- Karatteristiċi tal- Prodott li jagħmel wkoll parti mill- EPAR, għal aktar dettalji.
How is Docetaxel Winthrop used?
Kif jintuża Docetaxel Winthrop?
Docetaxel Winthrop should be used in specialised chemotherapy wards and it should only be given under the supervision of a doctor who is qualified in the use of anticancer chemotherapy.
Docetaxel Winthrop għandu jintuża fi swali tal- kimoterapija speċjalizzati u għandu jingħata biss taħt is- sorveljanza ta ’ tabib li jkun kwalifikat fl- użu tal- kimoterapija kontra l- kanċer.
Docetaxel Winthrop is only used when the neutrophil count (a type of white blood cell) is at least 1,500 cells/ mm3.
Docetaxel Winthrop jintuża biss meta n- numru ta ’ neutrophil (tip ta ’ ċelloli bojod fid- demm) ikun minn ta ’ l- inqas 1, 500 ċellola/ mm3.
Treatment with dexamethasone (an anti-inflammatory medicine) should be given to the patient on the day before treatment (for prostate cancer) or the day before and the two days after treatment (for other types of cancers).
It- trattament b’ dexamethasone (mediċina anti- infjammatorja) għandu jingħata lill - pazjent fil- ġurnata ta ’ qabel it- trattament (għal kanċer tal- prostata) jew għal ġurnata waħda qabel jew jumejn wara t- trattament (għat- tipi ta ’ kanċer oħrajn).
Docetaxel Winthrop is given as a one-hour infusion every three
Docetaxel Winthrop jingħata bħala infużjoni ta ’
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The dose, length of treatment, and its use with other medicines depend on the type of cancer being treated.
Id- doża, it- tul tat- trattament u l- użu tiegħu ma ’ mediċini oħra jiddependi mit - tip ta ’ kanċer li jkun qed jiġi trattat.
For more information, see the Summary of Product Characteristics.
Għal iktar tagħrif, ara s- Sommarju tal- Karatteristiċi tal- Prodott.
How does Docetaxel Winthrop work?
Kif jaħdem Docetaxel Winthrop?
The active substance in Docetaxel Winthrop, docetaxel, belongs to the group of anticancer medicines known as the taxanes.
Is- sustanza attiva f’ Docetaxel Winthrop, docetaxel tagħmel parti mill- grupp ta ’ mediċini ta ’ kontra l - kanċer magħrufa bħala taxanes.
Docetaxel blocks the ability of cells to destroy the internal ‘ skeleton ’ that allows them to divide and multiply.
Docetaxel jimblokka l- abilità taċ- ċellola li teqred l - ‘ istruttura ’ interna li jippermettilhom sabiex jiddividu u jimmoltiplikaw ruħhom.
With the skeleton still in place, the cells cannot divide and they eventually die.
Jekk l- istruttura tkun għada sħiħa, iċ - ċelloli ma jkunux jistgħu jiddividu ruħhom u eventwalment imutu.
Docetaxel also affects non-cancer cells such as blood cells, which can cause side effects.
Docetaxel jaffetwa wkoll ċelloli mhux tal- kanċer bħaċ- ċelloli tad- demm u dan jista ’ jikkawża xi effetti sekondarji.
How has Docetaxel Winthrop been studied?
Kif ġie studjat Docetaxel Winthrop?
Docetaxel Winthrop has been studied in a total of around 3,000 breast cancer patients, around 1,900 lung cancer patients, around 1,000 prostate cancer patients, 445 stomach cancer patients and 897 in head and neck cancer patients.
Docetaxel Winthrop ġie studjat f’ total ta ’ madwar 3000 pazjent morda bil- kanċer tas- sider, madwar 1, 900 pazjent b’ kanċer fil- pulmun, madwar 1, 000 pazjent b’ kanċer fil- prostata, 445 pazjent b’ kanċer fl- istonku u 897 pazjent b’ kanċer fir- ras u l- għonq.
In most of these studies, Docetaxel Winthrop was combined with other anticancer treatments and compared with combinations of different treatments or the same treatment without Docetaxel Winthrop.
Fil- biċċa l- kbira ta ’ dawn l- istudji, Docetaxel Winthrop ingħata flimkien ma ’ trattamenti oħra għal kontra l- kanċer u ġie pparagunat ma ’ taħlita ta ’ trattamenti differenti jew ma ’ l- istess trattament mingħajr Docetaxel Winthrop.
The main measure of effectiveness were the response rates (percentage of patients whose cancer responded to treatment), the time taken for the disease to progress and the increase in survival time.
Il- miżura ewlenija ta ’ kemm il- prodott huwa effikaċi kienu r- rati ta ’ rispons (il- perċentwal tal- pazjenti li l- kanċer tagħhom irrisponda għat- trattament), iż- żmien li ħadet il- marda biex tiprogressa u ż- żieda fiż- żmien ta ’ għajxien.
What benefit has Docetaxel Winthrop shown during the studies?
Liema benefiċċju wera Docetaxel Winthrop waqt l- istudji li ġew mwettqa?
The addition of Docetaxel Winthrop to other anticancer treatments produced significant increases in response rates, disease progression or survival, in all five types of cancer (breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma and head and neck cancer).
It- taħlita ta ’ Docetaxel Winthrop ma ’ trattamenti oħra kontra l- kanċer ġabet magħha żidiet importanti fir- rati ta ’ rispons, il- progressjoni tal- marda jew is- sopravivenza fil- ħames tipi ta ’ kanċer (kanċer tas - sider, kanċer tal- pulmun mhux ta ’ għamla ta ’ ċelloli żgħar, kanċer tal- prostata, adenocarcinoma ta ’ l - istonku u kanċer tar- ras u ta ’ l- għonq).
Used on its own in breast cancer, Docetaxel Winthrop was at least as effective as, and sometimes more effective than the comparator medicines.
Meta ntuża waħdu fil- kanċer tas- sider, Docetaxel Winthrop kien effikaċji daqs jew xi drabi iktar mill- mediċini li magħhom ġie pparagunat.
It was more effective than best supportive care therapy in lung cancer.
Kien iktar effikaċji mill- aħjar terapija ta ’ kura fil- kanċer tal- pulmun.
What is the risk associated with Docetaxel Winthrop?
X’ inhu r- riskju assoċjat ma ’ Docetaxel Winthrop?
The most common side effects in patients receiving Docetaxel Winthrop (seen in more than 1 patient in 10) are neutropenia (reduced white blood cell counts), anaemia (reduced red blood cell counts), thrombocytopenia (low blood platelet counts), febrile neutropenia (neutropenia with fever), peripheral sensory neuropathy (damage to the nerves causing numbness, tingling and pain in the hands and feet), peripheral motor neuropathy (damage to the nerves causing difficulty co-ordinating movements), dysgeusia (taste disturbances), dyspnoea (shortness of breath), stomatitis (inflammation of the lining of the mouth), diarrhoea, nausea (feeling sick), vomiting, alopecia (hair loss), skin reactions, nail disorders, myalgia (muscle pain), anorexia (loss of appetite), infections, fluid retention, asthenia (weakness), pain and hypersensitivity (allergic reactions).
L- aktar effetti sekondarji komuni fil- pazjenti li jirċievu Docetaxel Winthrop (muri f’ aktar minn pazjent minn kull 10) waħdu huma neutropenia (numru mnaqqas ta ’ ċelloli bojod tad- demm), anemia (numru mnaqqas ta ’ ċelloli ħomor tad- demm), thrombocytopenja (tnaqqis fil- għadd ta ’ platelets fid - demm), febrile neutropenia (newtropenja bid- deni), newropatija sensorjali periferali (ħsara fin - nervituri li tikkawża tgħarix, textix u uġigħ fl- idejn u s- saqajn), newropatija motorjali periferali (ħsara lin- nervituri li ġġib magħha diffikultà fil- koordinazjoni tal- movimenti), dysgeusia (disturbi fit - togħma), dyspnoea (diffikultà fit- teħid tan- nifs), stomatitis (infjamazzjoni fir- rita tal- ħalq), dijarea, nawżeja (tħossok ma tiflaħx), rimettar, alopecia (telf tax- xagħar), reazzjonijiet fil- ġilda, problemi fid - dwiefer, myalgia (uġigħ fil- muskoli), anoressija (telf ta ’ l- aptit), infezzjonijiet, żamma ta ’ fluwidi, astenja (dgħjufija), uġigħ u allerġiji (reazzjonijiet allerġiċi).
These side effects may be more severe when Docetaxel Winthrop is used with other anticancer medicines.
Dawn l- effetti sekondarji jistgħu jkunu iktar gravi meta Docetaxel Winthrop jintuża ma ’ mediċini oħra kontra l- kanċer.
For the full list of all side effects reported with Docetaxel Winthrop, see the Package Leaflet.
Għal- lista sħiħa ta ’ l - effetti sekondarji kollha rrapportati b’ Docetaxel Winthrop, ara l- Fuljett ta ’ Illustrazzjoni.
Docetaxel Winthrop should not be used in people who may be hypersensitive (allergic) to docetaxel or any of the other ingredients.
Docetaxel Winthrop m’ għandux jintuża f’ persuni li jistgħu jkunu sensittivi ż- żejjed (allerġiċi) għal docetaxel jew kull wieħed mill- ingredjenti l- oħra.
Docetaxel Winthrop should not be used in patients who have a neutrophil count of less than 1,500 cells/ mm3, in pregnant or breast-feeding women, or in patients who have severe liver disease.
Docetaxel Winthrop m’ għandux jintuża f’ pazjenti li għandhom numru ta ’ neutrophil li huwa inqas minn 1, 500 ċellola/ mm3, f’ nisa tqal jew li qed ireddgħu, jew f’ pazjenti li għandhom marda gravi tal- fwied.
Why has Docetaxel Winthrop been approved?
Għaliex ġie approvat Docetaxel Winthrop?
The Committee for Medicinal Products for Human Use (CHMP) decided that Docetaxel Winthrop’ s benefits are greater than its risks for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma and squamous cell head and neck cancer.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Docetaxel Winthrop jisbqu r- riskji tiegħu għat- trattament ta ’ kanċer tas- sider, kanċer tal- pulmun mhux ta ’ l- għamla ta ’ ċelluli żgħar, kanċer tal- prostata, adenocarcinoma ta ’ l- istonku u kanċer tat- tip ta ’ ċellola squamous tar- ras u ta ’ l- għonq.
The Committee recommended that Docetaxel Winthrop be given marketing authorisation.
Il- Kumitat irrakkomanda li Docetaxel Winthrop jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Docetaxel Winthrop:
Informazzjoni oħra dwar Docetaxel Winthrop:
The European Commission granted a marketing authorisation valid throughout the European Union for Docetaxel Winthrop to Aventis Pharma S. A. on 20 April 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Docetaxel Winthrop lil Aventis Pharma S. A fil - 20 ta ’ April 2007.
The full EPAR for Docetaxel Winthrop is available here.
L- EPAR sħiħ għal Docetaxel Winthrop jista ’ jinstab hawnhekk.
This summary was last updated in 11-2007.
Dan is- sommarju kien aġġornat l- aħħar fi 11- 2007.
Concentrate and solvent for solution for infusion
Konċentrat u solvent għal Użu għal ġol- vini soluzzjoni għall- infużjoni.
Concentrate: vial (glass); Solvent: vial (glass)
Konċentrat: kunjett (ħġieġ) Solvent: kunjett (ħġieġ)
Concentrate:
Konċentrat:
0.5 ml; Solvent:
0. 5ml Solvent:
Docetaxel Winthrop 20 mg concentrate and solvent for solution for infusion
Docetaxel Winthrop 20 mg konċentrat u solvent għal soluzzjoni għall- infużjoni
Each single-dose vial of Docetaxel Winthrop 20 mg concentrate contains docetaxel which is a trihydrate corresponding to 20 mg of docetaxel (anhydrous).
Kull kunjett b’ doża waħda ta ’ Docetaxel Winthrop 20 mg, konċentrat, li fih docetaxel li huwa tri- idrat, korrispondenti għal 20 mg ta ’ docetaxel (anidru).
The viscous solution contains 40 mg/ ml docetaxel (anhydrous).
Is- soluzzjoni magħquda fiha 40 mg/ ml ta ’ docetaxel (anidru).
Each single-dose vial of solvent contains 13% (w/ w) ethanol 95% in water for injection.
Kull kunjett b’ doża waħda ta ’ solvent huwa magħmul minn 13% (w/ w) t’ ethanol 95% fl- ilma għall- injezzjonijiet
Concentrate and solvent for solution for infusion.
Konċentrat u solvent għal soluzzjoni għall- infużjoni.
The concentrate is a clear viscous, yellow to brown-yellow solution.
Il- konċentrat huwa soluzzjoni ċara u magħquda, ta ’ kulur isfar għall- dak isfar jagħti fil- kanella.
The solvent is a colourless solution.
Is- solvent huwa soluzzjoni mingħajr kulur.
Breast cancer
Kanċer tas- sider
Docetaxel Winthrop in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node- positive breast cancer.
Docetaxel Winthrop flimkien ma ’ doxorubicin u cyclophosphamide huwa indikat għat- trattament miżjud f’ pazjenti li għandhom kanċer operabbli, u li nfirex fil- glandoli limfatiċi, tas- sider.
Docetaxel Winthrop in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.
Docetaxel Winthrop flimkien ma ’ doxorubicin huwa indikat għat- trattament ta ’ pazjenti b’ kanċer tas - sider lokalment avvanzat jew dak metastatiku, li ma kienux ħadu qabel terapija ċitotossika għal din il - marda.
Docetaxel Winthrop monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
Docetaxel Winthrop meta jingħata waħdu huwa indikat għat- trattament ta ’ pazjenti b’ kanċer tas- sider, lokalment avvanzat jew dak metastatiku, wara l- falliment ta ’ terapija ċitotossika.
Previous chemotherapy should have included an anthracycline or an alkylating agent.
It- terapija preċedenti kellha tinkludi xi anthracycline jew xi sustanza alkilika.
Docetaxel Winthrop in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress HER2 and who previously have not received chemotherapy for metastatic disease.
Docetaxel Winthrop flimkien ma ’ trastuzumab huwa indikat għat- trattament ta’ pazjenti b’ kanċer metastatiku tas- sider, liema tumuri jesprimu bil- qawwa HER2, u li preċedentement ma kienux ħadu kimoterapija għall- mard metastatiku.
Docetaxel Winthrop in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
Docetaxel Winthrop flimkien ma ’ capecitabine huwa indikat għat- trattament ta ’ pazjenti b’ kanċer tas - sider lokalment avvanzat jew dak metastatiku, wara l- falliment tal- kimoterapija ċitotossika.
Previous therapy should have included an anthracycline.
It- terapija preċedenti kellha tinkludi xi anthracycline.
Non-small cell lung cancer
Kanċer tal- pulmun mhux ta ’ l- għamla ta ’ ċelluli żgħar
Docetaxel Winthrop is indicated for the treatment of patients with locally advanced or metastatic non- small cell lung cancer after failure of prior chemotherapy.
Docetaxel Winthrop huwa indikat għat- trattament ta ’ pazjenti b’ kanċer tal- pulmun lokalment avvanzat jew dak metastatiku li mhux ta ’ ċelluli żgħar wara falliment ta ’ kimoterapija ċitotossika li ngħatat qabel.
Docetaxel Winthrop in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition.
2 Docetaxel Winthrop flimkien ma ’ cisplatin huwa indikat għat- trattament ta ’ pazjenti b’ kanċer tal - pulmun lokalment avvanzat jew dak metastatiku li mhux ta ’ ċelluli żgħar u li ma jistax jitneħħa f’ pazjenti li ma kinux ħadu qabel terapija ċitotossika għal din il- marda.
2 Prostate cancer
Kanċer tal- prostata
Docetaxel Winthrop in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
Docetaxel Winthrop flimkien ma ’ prednisone jew prednisolone huwa indikat għat- trattament tal - kanċer metastatiku tal- prostata, li ma jirrispondix għall- kura bl- ormoni.
Gastric adenocarcinoma
Adenokarċinoma ta ’ l- istonku
Docetaxel Winthrop in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.
Docetaxel Winthrop flimkien ma ’ cisplatin u 5- fluorouracil huwa indikat fit- trattament ta ’ pazjenti li għandhom adenokarċinoma metastatika ta ’ l- istonku, inkluż l- adenokarċinoma tal- parti fejn l- istonku jingħaqad ma ’ l- esofagu, u li ma kienux ħadu l- kimoterapija qabel, għal mard metastatiku.
Head and neck cancer
Kanċer tar- ras u ta ’ l- ghonq
Docetaxel Winthrop in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
Docetaxel Winthrop flimkien ma ’ cisplatin u 5- fluorouracil huwa indikat għat- trattament induttiv f’ pazjenti b’ kanċer tat- tip squamous tal- ġilda, lokalment avvanzat, tar- ras u l- għonq.
The use of docetaxel should be confined to units specialised in the administration of cytotoxic chemotherapy and it should only be administered under the supervision of a physician qualified in the use of anticancer chemotherapy (see section 6.6).
L- użu ta ’ docetaxel għandu jkun limitat biss f’ oqsma speċjaliżżati fl- għoti tal- kimoterapija ċitotossika u għandu jingħata biss taħt is- superviżjoni ta ’ tabib imħarreġ fl- użu tal- kimoterapija kontra l- kanċer (ara sezzjoni 6. 6).
Recommended dose
Doża rrakkomandat:
For breast, non-small cell lung, gastric, and head and neck cancers, premedication consisting of an oral corticosteroid, such as dexamethasone 16 mg per day (e. g.
Għall- każijiet ta ’ kanċer tas- sider, ta ’ l- istonku, tal- pulmun fejn iċ- ċelluli mhux żgħar, u tar- ras u ta ’ l - għonq, il- premedikazzjoni, b’ corticosteroid orali bħal dexamethasone 16 mg kuljum (e. g.
8 mg BID) for 3 days starting 1 day prior to docetaxel administration, unless contraindicated, can be used (see section 4.4).
8 mg BID) għal 3 ijiem, mibdija jum 1 qabel it- teħid ta ’ docetaxel, sakemm mhux kontra- indikat, tista ’ tintuża (ara sezzjoni 4. 4).
Prophylactic G-CSF may be used to mitigate the risk of hematological toxicities.
Il- profilassi b’ G- CSF tista ’ tintuża biex tnaqqas ir- riskju ta ’ effetti tossiċi ematoloġiċi.
For prostate cancer, given the concurrent use of prednisone or prednisolone the recommended premedication regimen is oral dexamethasone 8 mg, 12 hours, 3 hours and 1 hour before the docetaxel infusion (see section 4.4).
Għall- kanċer tal- prostata, sakemm l- użu konkomittanti ta ’ prednisone jew prednisolone jista ’ jsir, il - mod irrakkomandat tal- premedikazzjoni, huwa t- teħid ta ’ 8 mg dexamethasone oralment, 12- il siegħa, 3 sigħat u siegħa 1, qabel l- infużjoni ta ’ docetaxel (ara sezzjoni 4. 4).
Docetaxel is administered as a one-hour infusion every three weeks.
Docetaxel jingħata bħala infużjoni tul siegħa kull tliet ġimgħat.
Breast cancer In the adjuvant treatment of operable node-positive breast cancer, the recommended dose of docetaxel is 75 mg/ m2 administered 1-hour after doxorubicin 50 mg/ m2 and cyclophosphamide 500 mg/ m2 every 3 weeks for 6 cycles (see also Dose adjustments during treatment).
Kanċer tas- sider Fil- każ ta ’ trattament miżjud ta ’ kanċer operabbli tas- sider, li nfirex fil- glandoli limfatiċi, id- doża ta ’ docetaxel hija ta ’ 75 mg/ m2 li trid tingħata siegħa qabel doxorubicin 50 mg/ m2 u cyclophosphamide 500 mg/ m2, kull 3 ġimgħat għal 6 ċikli (ara ukoll l- aġġustamenti fid- Doża waqt it- trattament).
For the treatment of patients with locally advanced or metastatic breast cancer, the recommended dose of docetaxel is 100 mg/ m2 in monotherapy.
Fit- trattament ta ’ pazjenti li għandhom kanċer tas- sider lokalment avvanzat jew dak metastatiku, id - doża irrakkomandat ta ’ docetaxel huwa 100 mg/ m2 meta jintuża waħdu.
In first-line treatment, docetaxel 75 mg/ m2 is given in combination therapy with doxorubicin (50 mg/ m2).
Meta jintuża għall- kura preferita, docetaxel 75 mg/ m2 jingħata flimkien ma ’ doxorubicin (50 mg/ m2).
In combination with trastuzumab the recommended dose of docetaxel is 100 mg/ m2 every three weeks, with trastuzumab administered weekly.
Flimkien ma ’ trastuzumab, id- doża irrakkomandata ta ’ docetaxel hija 100 mg/ m2 kull tliet ġimgħat, b’ trastuzumab jingħata darba fil- ġimgħa.
In the pivotal trial the initial docetaxel infusion was started the day following the first dose of trastuzumab.
Fil- prova tal- pern l- infuzjoni inizjali ta ’ docetaxel inbdiet l - għada ta ’ l- ewwel doża ta ’ trastuzumab.
The subsequent docetaxel doses were administered immediately after completion of the trastuzumab infusion, if the preceding dose of trastuzumab was well tolerated.
Id- dożi sussegwenti ta ’ docetaxel kienu ngħataw immedjatament wara t- teħid komplet tal- infużjoni ta ’ trastuzumab, jekk id- doża ta ’ qabel ta ’ trastuzumab kienet ittollerata sew.
For trastuzumab dose and administration, see trastuzumab summary of product characteristics.
Għad- doża ta ’ trastuzumab u ta ’ kif għandu jingħata, ara s - sommarju tal- karatteristiċi tal- prodott ta ’ trastuzumab.
In combination with capecitabine, the recommended dose of docetaxel is 75 mg/ m2 every three weeks, combined with capecitabine at 1250 mg/ m2 twice daily (within 30 minutes after a meal) for 2 weeks followed by 1-week rest period.
Flimkien ma ’ capecitabine, id- doża irrakkomandata ta ’ docetaxel hija 75 mg/ m2 kull tliet ġimgħat, flimkien ma ’ capecitabine 1250 mg/ m2 darbtejn kuljum (fi żmien ta ’ 30 minuta wara l- ikel) għal
For capecitabine dose calculation according to body surface area, see capecitabine summary of product characteristics.
Biex tkun ikkalkulata d- doża ta ’ capecitabine skond l- erja tal- wiċċ tal- ġisem, ara l- karatteristiċi tal- prodott fil- qosor ta ’ capecitabine.
For treatment
Kanċer tal- pulmun fejn iċ ċelluli m’ humiex żgħar F’ pazjenti li qatt ma ħadu l- kimoterapija qabel u li qed jiġu ikkurati għall- kanċer tal- pulmun li mhux ta ’ ċelluli żgħar, is- sistema tad- dożi irrakkomandata hija docetaxel 75 mg/ m2 segwit immedjatament b’ cisplatin 75 mg/ m2 fuq perjodu ta ’ bejn 30 u 60 minuta.
3 after failure of prior platinum-based chemotherapy, the recommended dose is 75 mg/ m² as a single agent.
Għall- kura fejn il- kimoterapija preċedenti ibbażata fuq il- platinum falliet, id- doża irrakkomandata hija ta ’ 75 mg/ m2 bħala sustanza waħda.
Prostate cancer The recommended dose of docetaxel is 75 mg/ m2.
Kanċer tal- prostata Id- doża irrakkomandata ta ’ docetaxel hija 75 mg/ m2.
Prednisone or prednisolone 5 mg orally twice daily is administered continuously (see section 5.1).
Prednisone jew prednisolone meħud orali f’ doża ta ’ 5 mg darbtejn kuljum, jingħata bla waqfien (ara sezzjoni 5. 1).
Treatment is repeated every three weeks.
Adenokarċinoma ta ’ l- istonku Id- doża irrakkomandata ta ’ docetaxel hija 75 mg/ m2 mogħtija bħala infużjoni tul siegħa, segwita minn cisplatin 75 mg/ m2, bħala infuzjoni tul ta ’ 1 sa 3 sigħat (it- tnejn fl- ewwel jum biss), segwita minn 5 - fluorouracil 750 mg/ m2kuljum, mogħti bħala infużjoni kontinwa fuq medda ta ’ 24 siegħa għal 5 ijiem, mibdija fit- tmiem ta ’ l- infużjoni ta ’ cisplatin. It- trattament għandu jiġi ripetut kull tlett ġimgħat.
Patients must receive premedication with antiemetics and appropriate hydration for cisplatin administration.
Il - pazjenti għandhom jirċievu il- premedikazzjoni bl- anti- emetiċi u l- idratazzjoni xierqa qabel jingħata cisplatin.
Prophylactic G-CSF should be used to mitigate the risk of hematological toxicities (see also Dose adjustments during treatment).
Il- profilassi bil- G- CSF għandha tintuża biex tnaqqas ir- riskju ta ’ effetti tossiċi ematoloġiċi (Ara ukoll l- aġġustamenti fid- Doża waqt it- trattament).
Head and neck cancer Patients must receive premedication with antiemetics and appropriate hydration (prior to and after cisplatin administration).
Kanċer tar- ras u ta ’ l- għonq Il- pazjenti għandhom jirċievu il- premedikazzjoni bl- anti- emetiċi u l- idratazzjoni xierqa (qabel u wara li jingħata cisplatin).
All patients on the docetaxel-containing arm of the TAX 323 and TAX 324 studies, received prophylactic antibiotics.
Il- pazjenti kollha tal- fergħa ta ’ docetaxel ta ’ l- istudji TAX323 u TAX324 irċevew profilassi bl- antibijotiċi
• Induction chemotherapy followed by radiotherapy (TAX 323) For the induction treatment of inoperable locally advanced squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/ m2 as a 1 hour infusion followed by cisplatin 75 mg/ m2 over 1 hour, on day one, followed by 5-fluorouracil as a continuous infusion at 750 mg/ m2 per day for five days.
• Kimoterapija Induttiva segwita bi radjuterapija (TAX323) Fit- trattament induttiv ta ’ kanċer inoperabbli tat- tip squamous cell tal- ġilda, li huwa lokalment avvanzat, fir- ras u fl- għonq (SCCHN), id- doża irrakkomandata ta ’ docetaxel hija 75 mg/ m2 bħala infużjoni tul ta ’ siegħa, segwita minn cisplatin 75 mg/ m2 f’ tul ta ’ siegħa, fl- ewwel jum, segwit minn 5- fluorouracil bħala infużjoni mingħajr waqfien ta ’ 750 mg/ m2 kuljum għal ħamest ijiem.
This regimen is administered every 3 weeks for 4 cycles.
Dan ir- reġim jingħata kull 3 ġimgħat għal 4 ċikli.
Following chemotherapy, patients should receive radiotherapy.
Wara l- kimoterapija il- pazjenti għandhom jirċievu r- radjuterapija.
• Induction chemotherapy followed by chemoradiotherapy (TAX 324) For the induction treatment of patients with locally advanced (technically unresectable, low probability of surgical cure, and aiming at organ preservation) squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/ m2 as a 1 hour intravenous infusion on day 1, followed by cisplatin 100 mg/ m2 administered as a 30-minute to 3 hour infusion, followed by 5-fluorouracil 1000 mg/ m2/ day as a continuous infusion from day 1 to day 4.
• Kimoterapija Induttiva segwita bi kimoradjuterapija (TAX324) It- trattament induttiv ta ’ pazjenti li kellhom kanċer tat- tip squamous cell tar- ras u l- għonq (SCCHN) lokalment avvanzat (li teknikalment ma jistax jitneħħa, bi probabilita baxxa ta ’ kura kirurġika u bi skop ta ’ preservazzjoni ta ’ l- organi), id- doża rrakkomandata ta ’ docetaxel hija 75 mg/ m2 bħala infużjoni tul ta ’ siegħa, segwita minn cisplatin 100 mg/ m2 f’ tul ta ’ 30- minuta sa 3 sigħat, segwit minn 5- fluorouracil bħala infużjoni mingħajr waqfien ta ’ 1000 mg/ m2 kuljum minn jum 1 sa jum 4.
This regimen is administered every 3 weeks for 3 cycles.
Dan ir- reġim jingħata kull 3 ġimgħat għal 3 ċikli.
Following chemotherapy, patients should receive chemoradiotherapy.
Wara l - kimoterapija il- pazjenti għandhom jirċievu l- kimoradjuterapija.
For cisplatin and 5-fluorouracil dose modifications, see the corresponding summary of product characteristics.
Għall- modifikazzjonijiet fid- dożi ta ’ cisplatin u 5- fluorouracil, ara s- sommarju tal- karatteristiċi tal - prodott li tikkorrispondi.
Dose adjustments during treatment
Bidla fid- doża waqt il- kura:
General Docetaxel should be administered when the neutrophil count is ≥ 1,500 cells/ mm3.
Ġenerali Docetaxel għandu jingħata meta l- għadd taċ- ċelluli newtrofiliċi fid- demm huwa ≥ 1, 500 ċelluli/ mm3.
In patients who experienced either febrile neutropenia, neutrophil < 500 cells/ mm3 for more than one week, severe or cumulative cutaneous reactions or severe peripheral neuropathy during docetaxel therapy, the dose of docetaxel should be reduced from 100 mg/ m2 to 75 mg/ m2 and/ or from 75 to 60 mg/ m².
F’ pazjenti li kellhom jew id- deni flimkien man- newtropenija, b’ numru ta ’ < 500 ċelluli/ mm3 għal aktar minn ġimgħa, jew reazzjonijiet severi jew kumulattivi fil- ġilda, jew newropatija severa u periferika, waqt it- terapija bid- docetaxel, id- doża ta ’ docetaxel trid titnaqqas minn 100 mg/ m2 għal 75 mg/ m2 u/ jew minn 75 għal 60 mg/ m2.
If the patient continues to experience these reactions at 60 mg/ m², the treatment should be discontinued.
Jekk il- pazjent ikollu xorta dawn ir- reazzjonijiet b’ doża ta ’ 60 mg/ m2, it- trattament għandu jitwaqqaf.
Adjuvant therapy for breast cancer In the pivotal trial in patients who received adjuvant therapy for breast cancer and who experienced complicated neutropenia (including prolonged neutropenia, febrile neutropenia, or infection), it was recommended to use G-CSF to provide prophylactic coverage (eg, day 4 to 11) in all subsequent cycles.
4 Terapija miżjuda għal kanċer tas- sider Fil- prova tal- pern f’ pazjenti li ħadu terapija miżjuda għall- kanċer tas- sider u li kellhom newtropenija b’ komplikazzjonijiet (inklużi n- newtropenija fit- tul u n- newtrpenija akkompanjata bid- deni, jew l - infezzjoni), kien irrakkomandat l- użu ta ’ G- CSF biex jipprovdi protezzjoni profilattika (e. g. ir- 4 jum sal- 11- il jum) fiċ - ċikli kollha sussegwenti.
Patients who continued to experience this reaction should remain on G-CSF and have their docetaxel dose reduced to 60 mg/ m².
Il- pazjenti li baqgħu jkollhom din ir- reazzjoni għandhom jibqgħu fuq G- CSF u jkollhom id- doża tagħhom ta ’ docetaxel imnaqqsa għal 60 mg/ m2.
4 However, in clinical practice neutropenia could occur earlier.
Madankollu, fil- prattika klinika, in- newtropenija tista ’ tiġri qabel.
Thus the use of G-CSF should be considered function of the neutropenic risk of the patient and current recommendations.
Għalhekk, l- użu ta ’ G- CSF għandu jitqies bħala miżura fl- immaniġġar ta ’ dawk il- pazjenti li qegħdin f’ riskju u bħala parti mir - rakkomandazzjonijiet preżenti.
Patients who experience Grade 3 or 4 stomatitis should have their dose decreased to 60 mg/ m².
Il- pazjenti li jiżviluppaw stomatite ta ’ Grad 3 jew 4 għandhom jieħdu doża mnaqqsa għal 60 mg/ m2.
In combination with cisplatin For patients who are dosed initially at docetaxel 75 mg/ m2 in combination with cisplatin and whose nadir of platelet count during the previous course of therapy is < 25,000 cells/ mm3, or in patients who experience febrile neutropenia, or in patients with serious non-hematologic toxicities, the docetaxel dose in subsequent cycles should be reduced to 65 mg/ m2.
Meta jintuża flimkien ma ’ cisplatin F’ dawk il- pazjenti li fil- bidu qegħdin jieħdu docetaxel 75 mg/ m2, flimkien ma ’ cisplatin, u meta l - għadd tal- plejtlits laħaq il- livell baxx (in- nadir) ta ’ < 25, 000 ċelluli/ mm3, waqt il- kors preċedenti ta ’ terapija, jew f’ pazjenti li jiżviluppaw id- deni flimkien ma ’ newtropenija, jew f’ dawk il- pazjenti li għandhom effetti tossiċi u serji mhux ematoloġiċi, id- doża ta ’ docetaxel f ’ sussegwenti għandha titnaqqas għal 65 mg/ m2.
For cisplatin dose adjustments, see the corresponding summary of product characteristics.
Għall- bidla fid- doża ta ’ cisplatin, ara sommarju tal- karatteristiċi tal- prodott li tikkorrispondi.
In combination with capecitabine • For capecitabine dose modifications, see capecitabine summary of product characteristics. • For patients developing the first appearance of a Grade 2 toxicity, which persists at the time of the next docetaxel/ capecitabine treatment, delay treatment until resolved to Grade 0-1, and resume at 100% of the original dose. • For patients developing the second appearance of a Grade 2 toxicity, or the first appearance of a Grade 3 toxicity, at any time during the treatment cycle, delay treatment until resolved to Grade 0-1, then resume treatment with docetaxel 55 mg/ m². • For any subsequent appearances of toxicities, or any Grade 4 toxicities, discontinue the docetaxel dose.
Meta jintuża flimkien ma ’ capecitabine • Għat- tibdil fid- doża ta ’ capecitabine, ara sommarju tal- karatteristiċi tal- prodott ta ’ capecitabine. • Għal dawk il- pazjenti li titfaċċalhom l- ewwel darba t- tossiċità ta ’ Grad 2, li tippersisti saż- żmien meta jerġa ’ jkun imiss it- trattament b ’ docetaxel/ capecitabine, ittardja l- kura sakemm it- tossiċità tinżel għal Grad 0 sa 1, u mbagħad, erġa ’ ibda b’ 100% tad- doża oriġinali. • Għal dawk il- pazjenti li titfaċċalhom għat- tieni darba t- tossiċità ta ’ Grad 2, jew it- tossiċità ta ’ Grad 3 għall- ewwel darba, f’ kwalunkwe ħin waqt iċ- ċiklu tat- trattament, ittardja it- trattament sakemm it- tossiċità tinżel għal Grad 0 sa 1, u mbagħad kompli t- trattament b’ docetaxel 55 mg/ m2. • Għal kull grad ta ’ tossiċità li titfaċċa sussegwentement, jew għal- kwalunkwe tossiċità ta ’ Grad 4, waqqaf id- doża ta ’ docetaxel.
For trastuzumab dose modifications, see trastuzumab summary of product characteristics.
Għall- modifikazzjonijiet fid- doża ta ’ trastuzumab, ara s- sommarju tal- karatteristiċi tal- prodott.
In combination with cisplatin and 5-fluorouracil If an episode of febrile neutropenia, prolonged neutropenia or neutropenic infection occurs despite G-CSF use, the docetaxel dose should be reduced from 75 to 60 mg/ m2.
Jekk tinqala ’ episodju ta ’ newtropenija bid- deni, newtropenija fit- tul jew newtropenija assoċjata ma ’ infezzjoni, minkejja l- użu ta ’ G- CSF, id- doża ta ’ docetaxel trid titnaqqas minn 75 għal 60 mg/ m2.
If subsequent episodes of complicated neutropenia occur the docetaxel dose should be reduced from 60 to 45 mg/ m2.
Jekk jinqalgħu episodji oħra sussegwenti ta ’ newtropenija b ’ komplikazzjonijiet, id- doża ta ’ docetaxel għandha tiġi mnaqqsa minn 60 għal 45 mg/ m2.
In case of Grade 4 thrombocytopenia the docetaxel dose should be reduced from 75 to 60 mg/ m2.
Fil- każ ta ’ tromboċitopenija ta ’ Grad 4 id- doża ta ’ docetaxel għandha titnaqqas minn 75 għal 60 mg/ m2.
Patients should not be retreated with subsequent cycles of docetaxel until neutrophils recover to a level > 1,500 cells/ mm3 and platelets recover to a level > 100,000 cells/ mm3.
Il- pazjenti m’ għandhomx ikunu ittrattati b’ ċikli sussegwenti ta ’ docetaxel sakemm iċ- ċelluli newtrofiliċi tad- demm jirkupraw fl- għadd ta ’ > 1, 500 celloli/ mm3 u l- għadd tal- plejtlits jirkupra għal > 100, 000 ċelluli/ mm3.
(See section 4.4).
It- trattament għandu jitwaqqaf jekk dawn l- effetti tossiċi jippersistu (ara sezzjoni 4. 4).
Recommended dose modifications for toxicities in patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (5-FU):
Il- modifikazzjonijiet tad- dożi li huma irrakkomandati f’ pazjenti b’ tossiċita gastrointestinali ittrattati b’ docetaxel meta jintuża flimkien ma ’ cisplatin u 5- fluorouracil (5- FU):
Toxicity
5
Diarrhea grade 3
Tossiċità Dijarrea ta ’ grad 3
First episode: reduce 5-FU dose by 20%.
Aġġustament tad- doża L- ewwel episodju: naqqas id- doża ta ’ 5- FU b’ 20%.
Second episode: then reduce docetaxel dose by 20%.
It- tieniepisodju: imbagħad naqqas id- doża ta ’ docetaxel b’ 20%.
Diarrhea grade 4
Dijarrea ta ’ grad 4
First episode: reduce docetaxel and 5-FU doses by 20%.
L- ewwel episodju: naqqas id- dożi ta ’ docetaxel u 5- FU b’ 20%.
Second episode: discontinue treatment.
It- tieni episodju: waqqaf it- trattament.
Stomatitis/ mucositis grade 3
Stomatite/ mukożite ta ’ grad 3
First episode: reduce 5-FU dose by 20%.
L- ewwel episodju: naqqas id- doża ta ’ 5- FU b’ 20%.
Third episode: reduce docetaxel dose by 20%.
It- tieniepisodju: waqqaf 5- FU biss, fil- korsijiet kollha sussegwenti It- tielet episodju: naqqas id- doża ta ’ docetaxel b’ 20%.
Stomatitis/ mucositis grade 4
Stomatite/ mukożite ta ’ grad 4
Second episode: reduce docetaxel dose by 20%.
L- ewwel episodju: waqqaf 5- FU biss, fil- korsijiet kollha sussegwenti It- tieni episodju: naqqas id- doża ta ’ docetaxel b’ 20%.
For cisplatin and 5-fluorouracil dose adjustments, see the corresponding summary of product characteristics.
Għal aġġustamenti fid- dożi, fil- każ ta ’ cisplatin u 5- fluorouracil, ara s- sommarji tal- karatteristiċi tal - prodotti.
In the pivotal SCCHN trials patients who experienced complicated neutropenia (including prolonged neutropenia, febrile neutropenia, or infection), it was recommended to use G-CSF to provide prophylactic coverage (eg, day 6-15) in all subsequent cycles.
Fil- provi tal- pern SCCHN, il- pazjenti li kellhom newtropenija b ’ komplikazzjonijiet (li jinkludu newtropenija fit- tul, newtropenija bid- deni, jew infezzjoni), kien irrakkomandat l- użu ta ’ G- CSF biex jipprovdi protezzjoni profilattika (e. g. is- 6 jum sal- 15) fiċ - ċikli kollha sussegwenti.
5 Special populations
Pazjenti speċjali:
Patients with hepatic impairment Based on pharmacokinetic data with docetaxel at 100 mg/ m² as single agent, patients who have both elevations of transaminase (ALT and/ or AST) greater than 1.5 times the upper limit of the normal range (ULN) and alkaline phosphatase greater than 2.5 times the ULN, the recommended dose of docetaxel is 75 mg/ m2 (see sections 4.4 and 5.2).
Ibbażat fuq tagħrif farmakokinetiku bid- docetaxel f’ doża ta ’ 100 mg/ m2 meta mogħti waħdu, il- pazjenti li għandhom livelli għoljin ta ’ l- enżimi trasaminażi (ALT u/ jew AST) aktar minn 1. 5 drabi ta ’ l- ogħla livell tal- firxa normali (ULN) u l- livell tal- enzima alkaline phosphatase aktar minn 2. 5 drabi ta ’ l- ULN, id- doża irrakkomandata ta ’ docetaxel hija 75 mg/ m2 (ara - sezzjonijiet 4. 4 u 5. 2).
For those patients with serum bilirubin > ULN and/ or ALT and AST > 3.5 times the ULN associated with alkaline phosphatase > 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 tal- bilirubin fid- demm > ULN u/ jew l- ALT u l- AST > 3. 5 drabi ta ’ l- ULN, assoċjati ma ’ livelli ta ’ alkaline phosphatase ta ’ > 6 darbiet l - ULN, ma jistax jkun irrakkomandat it- tnaqqis fid- doża, u d- docetaxel m’ għandux jintuża sakemm huwa 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.
L- użu flinkien ma ’ cisplatin u 5- fluorouracil għat- trattament ta’ pazjenti b’ adenokarċinoma ta ’ l - istonku, l- istudju tal- pern eskluda pazjenti b’ ALT u/ jew AST > 1. 5 x ULN, assoċjat ma ’ alkaline phosphatase ta ’ > 2. 5 x ULN, u bilirubin > 1 x ULN; għal dawn il- pazjenti, tnaqqis fid- dożi ma jistgħux ikunu irrakkomandati u docetaxel m’ għandux jintuża, sakemm hu 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 b’ indeboliment tal- fwied ittrattati b’ docetaxel flimkien ma ’ l - indikazzjonijiet l- oħra.
Children and adolescents The experience in children is limited.
L- esperjenza fit- tfal hija limitata..
Elderly Based on a population pharmacokinetic analysis, there are no special instructions for use in the elderly.
M’ hemmx struzzjonijiet speċjali fuq l- użu fl- anzjani, ibbażati fuq analiżi farmakokinetika tal - popolazzjoni.
In combination with capecitabine, for patients 60 years of age or more, a starting dose reduction of capecitabine to 75% is recommended (see capecitabine summary of product characteristics).
Meta jintuża flimkien ma ’ capecitabine, għal pazjenti ta ’ 60 sena jew akbar fl- età, huwa irrakkomandat li l- ewwel doża ta ’ capecitabine tkun imnaqqsa għal 75% (ara s- sommarju tal- karatteristiċi tal- prodott ta ’ capecitabine).
Docetaxel must not be used in patients with baseline neutrophil count of < 1,500 cells/ mm3.
Docetaxel ma jistax jintuża f’ pazjenti fejn il- livell basiku tan- numru taċ- ċelluli newtrofiliċi fid- demm huwa < 1, 500 ċelluli/ mm3.
Docetaxel must not be used in pregnant or breast-feeding women.
Docetaxel ma jistax jintuża fit- tqala jew f’ nisa li qegħdin ireddgħu.
Docetaxel must not be used in patients with severe liver impairment since there is no data available (see sections 4.2 and 4.4).
6 Docetaxel ma jistax jintuża f’ pazjenti b’ indeboliment serju tal- fwied għaliex m’ hemmx data dwar dan (ara sezzjonijiet 4. 2 u 4. 4).
Contraindications for other medicinal products also apply, when combined with docetaxel.
Il- kontra- indikazzjonijet għall- prodotti mediċinali oħra japplikaw ukoll, meta jkunu użati flimkien ma ’ docetaxel.
For breast and non-small cell lung cancers, premedication consisting of an oral corticosteroid, such as dexamethasone 16 mg per day (e. g.
Għal kanċer tas- sider u dak tal- pulmun li mhux ta ’ l- għamla ta ’ ċelluli żgħar,, trid tingħata l - premedikazzjoni li tikkonsisti f’ corticsteroid orali, bħal dexamethasone 16 mg kuljum (e. g.