qanastek/EMEA-V3 huggingface dataset:
- yellowing of the skin and eye (jaundice)
- il- ġilda u l- għajnejn jisfaru (suffejra)
- hypersensitivity
- sensittività eċċessiva
HOW TO STORE XARELTO
KIF TAĦŻEN XARELTO
Do not use Xarelto after the expiry date which is stated on the carton and on each blister after EXP.
Tużax Xarelto wara d- data ta ’ skadenza, li tidher fuq il- kaxxa tal- kartun u fuq il- folja wara “ EXP ”.
What Xarelto contains
X' fih Xarelto
- The active substance is rivaroxaban.
- Is- sustanza attiva hi rivaroxaban.
Each tablet contains 10 mg of rivaroxaban.
Kull pillola fiha 10 mg ta 'rivaroxaban.
Tablet core: microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, hypromellose, sodium laurilsulfate, magnesium stearate.
Il- qalba tal- pillola: microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, hypromellose, sodium laurilsulfate, magnesium stearate.
Film coat: macrogol 3350, hypromellose, titanium dioxide (E171), iron oxide red (E172).
Kisja b’ rita: macrogol 3350, hypromellose, titanium dioxide (E171), iron oxide aħmar (E172).
What Xarelto looks like and contents of the pack The film-coated tablets are light red, round and marked with the BAYER-cross on one side and "10" and a triangle on the other side.
Id- Dehra ta 'Xarelto u l- kontenuti tal- pakkett Il- pilloli miksija b’ rita huma ta' kulur aħmar ċar, tondi, immarkati bis- salib tal- BAYER fuq naħa waħda, u bin - numru “ 10 ” u trijangolu fuq in- naħa l- oħra.
They come in blisters in cartons of 5, 10, 30 and 100 tablets.
Huma disponibbli f' folji f’ pakketti ta '5, 10, 30 u 100 pillola.
24 Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- Manifattur:
For more information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
24 Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l - Awtorizzazzjoni għat- Tqegħid fis- Suq:
EPAR summary for the public
XELEVIA Sommarju ta ’ l- EPAR għall- pubbliku
What is Xelevia?
X' inhi Xelevia?
Xelevia is a medicine containing the active substance sitagliptin.
Xelevia hija mediċina li fiha s- sustanza attiva sitagliptin.
It is available as round tablets.
Disponibbli bħala pilloli tondi.
What is Xelevia used for?
Għal x' hiex tintuża Xelevia?
Xelevia is used to treat patients with type 2 diabetes, to improve control of blood sugar levels.
Xelevia tintuża għat- trattament ta 'pazjenti bid- dijabete tat- tip 2, sabiex ittejjeb il- kontroll tal- livelli taz- zokkor fid- demm.
It is used with diet and exercise, together with one or more antidiabetes medicines: • in combination with metformin, in patients who are not satisfactorily controlled on metformin alone; • in combination with a sulphonylurea in patients who are not satisfactorily controlled with a sulphonylurea alone and in whom metformin is not suitable; • in combination with both metformin and a sulphonylurea, when both medicines are not sufficient to give satisfactory control of the patient ’ s diabetes; • in combination with a PPAR gamma agonist, such as a thiazolidinedione, in patients who are not satisfactorily controlled on the PPAR gamma agonist alone.
Tintuża ma 'dieta u eżerċizzju, flimkien ma' mediċina waħda jew aktar oħra kontra d- dijabete: • f' kombinazzjoni mal- metformina [metformin], f' pazjenti li mhumiex ikkontrollati biżżejjed bil - metformina biss; • f' kombinazzjoni mas- sulfonilurea [sulphonylurea] f' pazjenti li mhumiex ikkontrollati biżżejjed bis- sulfonilurea biss u li għalihom il- metformina mhijiex adegwata; • f' kombinazzjoni mal- metformina u s- sulfonilurea, meta ż- żewġ mediċini mhumiex biżżejjed biex jikkontrollaw b' mod sodisfaċenti d- dijabete ta 'pazjent; • f' kombinazzjoni ma' agonista PPAR- gamma [PPAR gamma agonist], bħat- thiazolidinedione, f' pazjenti li mhumiex ikkontrollati b' mod sodisfaċenti bl- agonista PPAR- gamma biss..
How is Xelevia used?
Kif tintuża Xelevia?
Xelevia is taken at a dose of 100 mg once a day, with or without food.
Xelevia tittieħed b' doża ta '100 mg darba kuljum, waħedha jew ma' l- ikel.
There is no need to change the doses of the other medicines Xelevia is taken with, except when Xelevia is taken with a sulphonylurea.
Mhuwiex meħtieġ li jiġu modifikati d- dożi tal- mediċini l- oħra li magħhom tittieħed Xelevia, ħlief meta Xelevia tittieħed ma 'sulfonilurea.
In such cases, the dose of the sulphonylurea may be lowered to reduce the risk of hypoglycaemia (low blood sugar levels).
F' każijiet bħal dawn, huwa possibbli li titnaqqas id- doża ta 'sulfonilurea biex jitbaxxa r - riskju ta' ipogliċemija (livelli baxxi ta 'zokkor fid- demm).
Xelevia is not recommended for use in patients who have moderate or severe problems with their kidneys, or in patients aged less than 18 years.
L- użu ta 'Xelevia mhuwiex rakkomandat għal pazjenti li għandhom problemi bil- kliewi moderati jew gravi, jew f' pazjenti li għandhom inqas minn 18- il sena.
How does Xelevia work?
Kif taħdem Xelevia?
The active substance in Xelevia, sitagliptin, is a dipeptidyl peptidase 4 (DPP-4) inhibitor.
Is- sustanza attiva f' Xelevia, sitagliptin, hija inibitur tat- tip tad- dipeptidil- peptidażi 4 (DPP- 4, dipeptidyl peptidase 4).
It works by blocking the breakdown of ‘ incretin’ hormones in the body.
Taħdem billi timblokka d- degradazzjoni ta 'l- ormoni ta' l - 'inkretina' fil- ġisem.
By increasing levels of incretin hormones in the blood, sitagliptin stimulates the pancreas to produce more insulin when blood sugar levels are high.
Billi żżid il - livelli ta 'l- ormoni ta' l- inkretina fid- demm, sitagliptin jistimula l- frixa sabiex tipproduċi aktar insulina meta l- livelli taz- zokkor fid- demm ikunu għoljin.
Sitagliptin does not work when the blood sugar is low.
Sitaglipin ma jaħdimx meta l- livell ta 'zokkor fid - demm huwa baxx.
Sitagliptin also reduces the amount of sugar made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Sitagliptin inaqqas ukoll l- ammont ta 'zokkor prodott mill- fwied, billi jżid il- livelli
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. ta 'l- insulina u jnaqqas il- livelli ta' l- ormon glukagon.
How has Xelevia been studied?
Kif ġiet studjata Xelevia?
The effects of Xelevia were first tested in experimental models before being studied in humans.
Għall- ewwel, l- effetti ta 'Xelevia ġew ittestjati f' mudelli sperimentali qabel ġew studjati fuq il - bnedmin.
Xelevia was studied in five main studies lasting up to a year, involving almost 4,000 patients with type 2 diabetes whose blood sugar levels were not adequately controlled.
Xelevia ġiet studjata f’ ħames studji prinċipali li damu sa sena, u li involvew kważi 4, 000 pazjent bid- dijabete tat- tip 2 li l- livelli ta 'zokkor fid- demm tagħhom ma kinux ikkontrollati b' mod adegwat.
Four of the studies compared Xelevia to placebo (a dummy treatment), either taken alone (two studies involving 1,262 patients), or as an add-on to metformin (in 702 patients) or to the PPAR gamma agonist pioglitazone (in 353 patients).
Erbgħa mill- istudji qabblu Xelevia mal- plaċebo (trattament finta), jew meta tittieħed waħedha (żewġ studji li involvew 1, 262 pazjent), jew meta miżjuda mal- metformina (f' 702 pazjenti) jew mal- pioglitazone agonista tal- PPAR- gamma (fi 353 pazjent).
The fifth study compared Xelevia to glipizide (a sulphonylurea), as an add-on to metformin in 1,172 patients.
Il- ħames studju qabbel Xelevia ma 'glipizide (sulfonilurea), bħala żieda mal- metformina f' 1, 172 pazjent.
An additional study compared Xelevia to placebo, when used as an add-on to treatment with glimepiride (another sulphonylurea), with or without metformin, in 441 patients.
Studju addizzjonali qabbel Xelevia ma 'plaċebo, meta użat bħala żieda mat- trattament bil- glimepiride (sulfonilurea oħra), bil - metformina jew mingħajrha, f' 441 pazjent.
What benefit has Xelevia shown during the studies?
X’ benefiċċju wriet Xelevia matul l- istudji?
Xelevia was more effective than placebo when it was taken alone or in combination with other antidiabetes medicines.
Xelevia kienet aktar effikaċi mill- plaċebo meta ttieħdet waħedha jew flimkien ma 'mediċina oħra kontra d- dijabete.
In combination with metformin, a daily dose of 100 mg Xelevia reduced HbA1c by 0.70% (from 7.96 to 7.26%) after 24 weeks, compared to a fall of 0.08% in the patients adding placebo.
F' kombinazzjoni mal- metformina, doża ta 'kuljum ta' 100 mg Xelevia naqset l- HbA1c b' 0. 70% (minn 7. 96 għal 7. 26%) wara 24 ġimgħa, meta mqabbla ma 'tnaqqis ta' 0. 08% fil- pazjenti li ħadu wkoll il - plaċebo.
In combination with pioglitazone, 100 mg Xelevia reduced HbA1c levels by 0.88% after 24 weeks, compared to 0.18% in the patients adding placebo.
F' kombinazzjoni mal- pioglitazone, doża ta '100mg Xelevia naqset il- livelli ta' HbA1c b' 0. 88% wara 24 ġimgħa, meta mqabbla ma 'tnaqqis ta' 0. 18% fil- pazjenti li ħadu wkoll il- plaċebo.
In the study comparing Xelevia and glipizide as an add-on to metformin, glipizide was initially more effective than Xelevia in reducing HbA1c levels.
Fl - istudju li jqabbel Xelevia u glipizide miżjud mal- metformina, fil- bidu, glipizide kien aktar effikaċi minn Xelevia fit- tnaqqis tal- livelli ta 'HbA1c.
However, in patients continuing to take Xelevia or glipizide, the two medicines had similar levels of effectiveness after a year of treatment.
Madankollu, f' pazjenti li baqgħu jieħdu Xelevia jew glipizide, iż- żewġ mediċini kellhom livelli simili ta 'effikaċja wara sena ta' trattament.
Xelevia was also more effective than placebo when it was added to glimepiride (with and without metformin).
Xelevia kien ukoll aktar effikaċi mill- plaċebo meta żdiedet ma 'glimepiride (bil- metformina jew mingħajrha).
This reduced HbA1c levels after 24 weeks by 0.30% in patients receiving Xelevia and glimepiride, and by 0.60% in the patients who were also taking also taking metformin in addition to Xelevia and glimepiride.
Wara 24 siegħa, dan naqqas il- livelli ta 'HbA1c b' 0. 30% fil- pazjenti li ħadu Xelevia jew glimepiride u b' 0. 60% f' pazjenti li ħadu wkoll il- metformina flimkien ma' Xelevia u glimepiride.
What is the risk associated with Xelevia?
X’ inhu r- riskju assoċjat ma ’ Xelevia?
This is seen in more than 1 patient in 10 when Xelevia is taken with a sulphonylurea (with or without metformin) and in between 1 and 10 patients in 100 when Xelevia is taken with a PPAR gamma agonist.
L- aktar effett sekondarju komuni meta Xelevia tittieħed ma 'mediċini oħra huwa l- ipogliċemija, osservata f' aktar minn pazjent wieħed minn għaxra meta Xelevia tittieħed mas- sulfonilurea (bil - metformina jew mingħajrha) u bejn pazjent wieħed u għaxra minn 100 meta Xelevia tittieħed ma' agonista PPAR- gamma.
When Xelevia is taken with metformin only, the most common side effect (seen in between 1 and 100 patients in 100) is nausea (feeling sick).
Meta Xelevia tittieħed mal- metformina biss, l- aktar effett sekondarju komuni (osservat f' bejn wieħed u għaxar pazjenti minn 100) hija n- nawżea (dardir).
For the full list of all side effects reported with Xelevia, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji kollha rrapportati b' Xelevia, ara l- Fuljett ta' Tagħrif.
Xelevia should not be used in people who may be hypersensitive (allergic) to sitagliptin or any of the other ingredients.
Xelevia ma għandhiex tintuża f' persuni li aktarx ikun ipersensittivi (allerġiċi) għal sitagliptin jew għal xi sustanza oħra.
Why has Xelevia been approved?
Għaliex Xelevia ġiet approvata?
The Committee recommended that Xelevia be given marketing authorisation.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Xelevia huma aktar mir- riskji tagħha għat- trattament ta 'pazjenti bid- dijabete mellitu tat- tip 2 sabiex ittejjeb il- kontroll gliċemiku f' kombinazzjoni mal- metformina u/ jew sulfonilurea, jew agonista PPAR - gamma, meta dieta u eżerċizzju flimkien ma' mediċina waħda ma jipprovdux kontroll gliċemiku adegwat.
Other information about Xelevia:
Tagħrif ieħor dwar Xelevia:
The European Commission granted a marketing authorisation valid throughout the European Union for Xelevia to Merck Sharp & Dohme Ltd. on 21 March 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha, għal Xelevia lil Merck Sharp & Dohme Ltd fil- 21 ta 'Marzu 2007.
The full EPAR for Xelevia can be found here.
EPAR sħiħ għal Xelevia huwa disponibbli minn hawn.
What is Xeloda?
X’ inhu Xeloda?
Xeloda is a medicine that contains the active substance capecitabine.
Xeloda huwa mediċina li fiha s- sustanza attiva kapeċitabina (capecitabine).
It is available as peach-coloured tablets (150 and 500 mg).
Huwa disponibbli f’ pilloli lewn il- ħawħ (150 u 500 mg).
What is Xeloda used for?
Għal xiex jintuża Xeloda?
Xeloda is an anticancer medicine.
Xeloda huwa mediċina kontra l- kanċer.
It is used to treat: • colon (large bowel) cancer.
Jintuża għat- trattament ta ’: • kanċer tal- kolon (tal- musrana l- għamja).
Xeloda is used with or without other anticancer medicines in patients who have had surgery for ‘ stage III’ or ‘ Dukes’ stage C’ colon cancer; • metastatic colorectal cancer (cancer of the large bowel that has spread to other parts of the body).
Xeloda jintuża waħdu jew ma ’ mediċini oħra kontra l - kanċer f’ pazjenti li kienu sottoposti għal intervent kirurġiku għal kanċer tal- kolon tal - ‘ fażi III ’ jew ‘ fażi C ta ’ Dukes ’; • kanċer kolorettali metastatiku (kanċer tal- musrana l- għamja li jkun infirex għal partijiet oħra tal - ġisem).
Xeloda is used with or without other anticancer medicines; • advanced gastric (stomach) cancer.
Xeloda jintuża waħdu jew ma ’ mediċini oħra kontra l- kanċer; • kanċer gastriku (fl- istonku) fi stadju avvanzat.
Xeloda is used with other anticancer medicines, including a platinum-containing anticancer medicine such as cisplatin; • locally advanced or metastatic breast cancer (breast cancer that has begun to spread to other parts of the body).
Xeloda jintuża flimkien ma ’ medicini oħra kontra l - kanċer, inklużi mediċini kontra l- kanċer li jkun fihom il- platinu bħaċ- ċisplatina; • kanċer tas- sider lokalment avvanzat jew metastatiku (kanċer tas- sider li beda jinfirex ma ’ partijiet oħra tal- ġisem).
Xeloda is used with docetaxel (another anticancer medicine) after treatment with anthracyclines (another type of anticancer medicine) has failed.
Xeloda jintuża ma ’ docetaxel (mediċina oħra kontra l- kanċer) wara li jkun falla trattament bl- antraċiklini (anthracyclines) (tip ieħor ta ’ mediċini kontra l- kanċer).
It can also be used on its own when treatment with both anthracyclines and taxanes (another type of anticancer medicine) has failed or when repeat treatment with anthracyclines is not suitable for the patient.
Jista ’ jintuża wkoll waħdu meta jkun falla t- trattament kemm bl- antraċiklini kif ukoll bit- tassani (taxanes) (tip ieħor ta ’ mediċina kontra l- kanċer) jew meta trattament ripetut bl- antraċiklini ma jkunx adegwat għall- pazjent.
How is Xeloda used?
Kif jintuża Xeloda?
Xeloda should only be prescribed by a doctor who is qualified in the use of anticancer medicines.
Xeloda għandu jingħata biss minn tabib li jkun ikkwalifikat fl- użu tal- mediċini kontra l- kanċer.
Xeloda is taken twice a day at doses between 625 and 1,250 mg per square metre body surface area (calculated using the patient ’ s height and weight).
Xeloda jittieħed darbtejn kuljum b’ dożi ta ’ bejn 625 u 1, 250 mg għal kull metru kwadru tas- superfiċje tal- ġisem (li jiġi kkalkulat permezz tat- tul u l- piż tal- pazjent).
The dose depends on the type of cancer being treated.
Id- doża tiddependi mit- tip ta ’ kanċer li jkun qed jiġi ttrattat.
The doctor will calculate the number of 150- and 500-mg tablets the patient needs to take.
It- tabib jikkalkula n- numru ta ’ pilloli ta ’ 150 mg jew ta ’ 500 mg li jkollu bżonn jieħu l- pazjent.
Xeloda tablets should be swallowed with water within the 30 minutes after a meal.
Il- pazjent għandu jibla ’ l- pilloli ta ’ Xeloda mal- ilma sa 30 minuta wara l- ikel.
Treatment is continued for six months after colon surgery.
It- trattament jitkompla għal sitt xhur wara l- intervent kirurġiku fil- kolon.
For other types of cancer, treatment is stopped if the disease gets worse or the patient cannot tolerate the treatment.
F’ każijiet ta ’ tipi oħra ta ’ kanċer, it- trattament jitwaqqaf jekk tiggrava l- marda jew jekk il- pazjent ma jistax jittollera t- trattament.
Doses need to be adjusted for patients with liver or kidney disease and for patients who develop certain side effects.
Id- dożi għandhom jiġu aġġustati għal pazjenti b’ mard tal- fwied jew tal- kliewi u għal pazjenti li jkunu żviluppaw ċerti effetti sekondarji.
Full details are available in the Summary of Product Characteristics (also part of the EPAR).
Aktar dettalji huma disponibbli fis- Sommarju tal- Karatteristiċi tal- Prodott (parti wkoll mill- EPAR).
How does Xeloda work?
Kif jaħdem Xeloda?
The active substance in Xeloda, capecitabine, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group ‘ anti-metabolites’.
Is- sustanza attiva f’ Xeloda, kapeċitabina, hija mediċina ċitotossika (mediċina li toqtol iċ- ċelloli li jkunu qed jimmultiplikaw, bħaċ- ċelloli tal- kanċer) li jkunu parti mill- grupp tal - ‘ antimetaboliti ’.
Capecitabine is a ‘ prodrug ’ that is converted to 5-fluorouracil (5-FU) in the body, but more is converted in tumour cells than in normal tissues.
Il - kapeċitabina hija ‘ promediċina ’ li tiġi metabolizzata fil- ġisem bħala f’ 5- fluorouracil (5- FU), iżda fiċ - ċelloli tat- tumuri din tiġi kkonvertita iktar f’ ċelloli tal- kanċer milli f’ tessuti b’ saħħithom.
It is taken as tablets, while 5-FU normally needs to be injected.
Tittieħed bħala pilloli, filwaqt li 5- FU normalment tkun trid tiġi injettata.
5-FU is an analogue of pyrimidine.
5- FU hu analogu tal- pirimidina (pyrimidine).
Pyrimidine is part of the genetic material of cells (DNA and RNA).
Il- pirimidina hi parti mill- materjal ġenetiku taċ- ċelloli (DNA u RNA).
In the body, 5-FU takes the place of pyrimidine and interferes with the enzymes involved in making new DNA.
Fil- ġisem, 5- FU jissostitwixxi l- pirimidina u jinterferixxi mal- enzimi li jieħdu sehem fil- produzzjoni ta ’ DNA ġdid.
As a result, it inhibits the growth of tumour cells and eventually kills them.
Minħabba f’ hekk, jinibixxi t- tkabbir taċ- ċelloli tal- kanċer u eventwalment joqtolhom.
How has Xeloda been studied?
Kif ġie studjat Xeloda?
In colon cancer, Xeloda on its own has been compared with the combination of 5-FU and folinic acid (a medicine that enhances the effects of 5-FU) in 1,987 patients who had previously had surgery for their cancer.
Fil- kanċer tal- kolon, Xeloda waħdu tqabbel ma ’ kombinazzjoni ta ’ 5- FU u ta ’ aċidu foliniku (mediċina li ttejjeb l- effetti ta ’ 5- FU) f’ 1, 987 pazjent li kienu preċedentement sottoposti għal intervent kirurġiku għall- kanċer tagħhom.
In metastatic colorectal cancer, Xeloda taken on its own has been compared with the combination of 5-FU and folinic acid in two studies involving 1,207 patients.
Fil- kanċer kolorettali metastatiku, Xeloda waħdu tqabbel mal- kombinazzjoni ta ’ 5- FU u aċidu foliniku f’ żewġ studji li fihom ħadu sehem 1, 207 pazjenti.
Xeloda has also been compared with the combination of 5-FU and folinic acid, both in combination with oxaliplatin (another anticancer medicine), in two studies: the first involved 2,035 patients who had not been treated before, and the second involved 627 patients who had failed previous treatment with irinotecan and a fluoropyrimidine (a group of anticancer medicines that includes 5-FU).
Xeloda tqabbel ukoll mal- kombinazzjoni ta ’ 5- FU u aċidu foliniku, fejn it- tnejn ittieħdu flimkien mal- ossaliplatina (oxaliplatin - mediċina oħra kontra l - kanċer), f’ żewġ studji: l- ewwel wieħed kien jinvolvi 2, 035 pazjent li ma kinux ġew ittrattati qabel, u t - tieni wieħed kien jinvolvi 627 pazjent li kienu fallew it- trattament preċedenti b’ irinotecan u fluworopirimidina (fluoropyrimidine) (grupp ta ’ mediċini kontra l- kanċer li jinkludi 5- FU).
In advanced gastric cancer, Xeloda with cisplatin has been compared with a combination of 5-FU and cisplatin in one study involving 316 patients.
Fil- kanċer gastriku avvanzat, Xeloda maċ- ċisplatina tqabbel ma ’ kombinazzjoni ta ’ 5- FU u ċisplatina fi studju wieħed li fih ħadu sehem 316- il pazjent.
The company also presented the results of a published study involving 1,002 patients, which compared the effects of Xeloda and 5-FU, taken in combination with platinum-containing medicines and epirubicin (another anticancer medicine).
Il- kumpanija ppreżentat ukoll ir- riżultati ta ’ studju ppubblikat li fih ħadu sehem 1, 002 pazjenti, li qabblu l- effetti ta ’ Xeloda u 5- FU, meħudin flimkien ma ’ mediċini li jkun fihom il- platinu u l- epirubiċina (epirubicin - mediċina oħra kontra l- kanċer).
In locally advanced or metastatic breast cancer, Xeloda with docetaxel has been compared with docetaxel on its own in 511 women.
Fil- kanċer tas- sider lokalment avvanzat jew metastatiku, Xeloda flimkien ma ’ docetaxel tqabbel ma ’ docetaxel waħdu f’ 511- il mara.
Two smaller studies (238 patients) have also looked at the effectiveness of Xeloda after failure of treatment with taxanes and anthracyclines.
Żewġ studji fuq skala iżgħar (238 pazjent) eżaminaw ukoll l- effikaċja ta ’ Xeloda wara l- falliment tat- trattament bit- tassani u l- antraċiklini.
The main measures of effectiveness were the number of patients whose cancer responded to treatment, how long it took for the disease to progress, how long the patients remained disease-free or how long they survived.
Il- kejl ewlieni tal- effikaċja kien l- għadd ta ’ pazjenti li l- kanċer tagħhom irrisponda għat- trattament, iż - żmien li l- marda ħadet biex tagħmel progress, iż- żmien li fih il- pazjenti baqgħu ħielsa mill- marda jew iż- żmien tas- sopravivenza.
What benefit has Xeloda shown during the studies?
Liema benefiċċju wera Xeloda waqt l- istudji mwettqa?
In colon cancer, Xeloda was also as effective as 5-FU and folinic acid, with about two-thirds of the patients remaining disease-free throughout the 3.8 years of the study.
Fil- kanċer tal- kolon, Xeloda rriżulta wkoll effikaċi daqs 5- FU u l- aċidu foliniku, b’ madwar żewġ terzi tal- pazjenti jibqgħu ħielsa mill- marda matul it- 3. 8 snin tal- istudju.
In metastatic colorectal cancer, Xeloda was as effective as the combination of 5-FU and folinic acid.
Fil- kanċer kolorettali metastatiku, Xeloda kien effikaċi daqs il- kombinazzjoni ta ’ 5- FU u l- aċidu foliniku.
When taken alone, between 19 and 25% of patients responded to Xeloda, and 12 to 15% responded to the comparator combination.
Meta meħud waħdu, bejn 19 u 25% tal- pazjenti rrispondew għal Xeloda, u bejn 12 u 15% rrispondew għall- kombinazzjoni tat- tqabbil.
When either Xeloda or 5-FU and folinic acid were taken with oxaliplatin, it took an average of eight months for the disease to get worse in patients who had not been treated before, and five months in patients whose previous treatment had failed.
Meta Xeloda jew 5- FU u l- aċidu folinku ttieħdu mal - ossaliplatina, il- marda ggravat f’ medja ta ’ tmien xhur fil- pazjenti li ma kinux sottoposti għall- ebda trattament qabel, u ħames xhur fil- pazjenti li kien fallielhom it- trattament preċedenti.
In advanced gastric cancer, Xeloda with cisplatin was as effective as 5-FU and cisplatin.
Fil- kanċer gastriku avvanzat, Xeloda maċ- ċisplatina kien effikaċi daqs 5- FU u ċ- ċisplatina.
It took 5.6 months for the disease to get worse in patients taking Xeloda and cisplatin, and 5.0 months in patients receiving 5-FU and cisplatin.
Fil - pazjenti ttrattati bi Xeloda u ċ- ċisplatina, il- marda damet 5. 6 xhur biex tiggrava filwaqt li fil- pazjenti ttrattati b’ 5- FU u ċ- ċisplatina damet 5. 0 xhur.
The published study showed that patients taking combinations of medicines that included Xeloda survived for a similar length of time as those taking combinations including 5-FU.
L- istudju ppubblikat wera li l- pazjenti ttrattati b’ kombinazzjoni ta ’ mediċini li kienu jinkludu Xeloda ssopravivew għal tul ta ’ żmien simili għal dawk ittrattati b’ kombinazzjonjiet li kienu jinkludu 5- FU.
In locally advanced or metastatic breast cancer, Xeloda combined with docetaxel was more effective that docetaxel on its own in increasing how long it took for the disease to get worse (186 days compared with 128 days).
Fil- kanċer tas- sider lokalment avvanzat jew metastatiku, Xeloda flimkien ma ’ docetaxel kien aktar effikaċi minn docetaxel meħud waħdu biex itawwal iż- żmien biex tiggrava l- marda (186 jum meta mqabbla ma ’ 128 jum).
What is the risk associated with Xeloda?
X’ riskji huma assoċjati ma ’ Xeloda?
The most common side effects with Xeloda (seen in more than 1 patient in 10) are anorexia (loss of appetite), diarrhoea, vomiting, nausea (feeling sick), stomatitis (sores in the mouth), abdominal (tummy) pain, palmar-plantar erythrodysaesthesia syndrome (‘ hand-foot syndrome’, a skin reaction with rash and pain on the hands and feet), fatigue (tiredness) and asthenia (weakness).
L- effetti sekondarji l- aktar komuni bi Xeloda (li dehru f’ iktar minn pazjent 1 minn 10) kienu anoressija (telf ta ’ aptit), dijarrea, remettar, nawżea (dardir), stomatite (selħiet fil- ħalq), uġigħ addominali (ta ’ żaqq), sindromu tal- eritrodisestesija palmo- plantari (‘ sindromu id- sieq ’, reazzjoni fil - ġilda b’ raxx u wġigħ fl- idejn u s- saqajn), għeja u astenija (debbulizza).
For the full list of all side effects reported with Xeloda, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji kollha rrapportati bi Xeloda, ara l- Fuljett ta ’ Tagħrif.
Xeloda should not be used in people who may be hypersensitive (allergic) to capecitabine, to any of the other ingredients, or to fluorouracil.
2/ 3 Xeloda ma għandux jintuża f’ persuni li jistgħu jkunu ipersensittivi (allerġiċi) għall- kapeċitabina, għal xi sustanza oħra tiegħu jew għal fluorouracil.
Xeloda should also not be used in the following groups: • patients who have had severe and unexpected reactions to fluoropyrimidine therapy (a group of anticancer medicines); 2/ 3 • patients with dihydropyrimidine dehydrogenase deficiency (low levels of an enzyme); • pregnant or breast-feeding women; • patients with severe leucopenia, neutropenia, or thrombocytopenia (low levels of white cells or platelets in the blood); • patients with severe liver or kidney disease; • patients treated with sorivudine or similar anticancer medicines such as brivudine within the last four weeks.
Xeloda lanqas ma għandu jintuża f’ dawn is - sitwazzjonijiet: • f’ pazjenti bi storja ta ’ reazzjonijiet gravi jew mhux mistennija għat- terapija bi fluworopirimidina (grupp ta ’ mediċini kontra l- kanċer); • f’ pazjenti b’ defiċjenza ta ’ diidropirimidina deidroġenażi (dihydropyrimidine dehydrogenase - livelli baxxi ta ’ enzima); • matul it- tqala jew it- treddigħ; • f’ pazjenti li jbatu minn forom gravi ta ’ lewkopenija, newtropenija jew tromboċitopenija (livelli baxxi ta ’ ċelloli bojod jew ta ’ platelets fid- demm); • f’ pazjenti li jbatu minn mard gravi tal- fwied jew tal- kliewi; • f’ pazjenti ttrattati bis- sorivudina (sorivudine) jew mediċini kontra l- kanċer simili bħall- brivudina (brivudine) sal- aħħar erba ’ ġimgħat.
Why has Xeloda been approved?
Għaliex ġie approvat Xeloda?
The Committee for Medicinal Products for Human Use (CHMP) decided that Xeloda’ s benefits are greater than its risks for: • the adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer; • the treatment of metastatic colorectal cancer; • first-line treatment of advanced gastric cancer in combination with a platinum-based regimen; • the treatment of patients with locally advanced or metastatic breast cancer either in combination with docetaxel after failure of anthracycline chemotherapy, or as monotherapy after failure of both anthracycline and taxane chemotherapy or when further anthracycline therapy is not indicated.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Mill- Bniedem (CHMP) iddeċieda li l- benefiċċju ta ’ Xeloda huma ogħla mir- riskji tiegħu għal: • trattament addizzjonali ta ’ pazjenti sottoposti għal intervent kirurġiku għal kanċer tal- kolon fil - fażi III (fażi C ta ’ Dukes); • trattament ta ’ kanċer kolorettali metastatiku; • trattament tal- ewwel linja (‘ first- line treatment ’) għall- kanċer gastriku avvanzat flimkien ma ’ reġim ibbażat fuq il- platinu; • trattament ta ’ pazjenti b’ kanċer tas- sider lokalment avvanzat jew metastatiku jew flimkien ma ’ docetaxel wara falliment tal- kemjoterapija bl- antraċiklina, jew bħala monoterapija wara falliment taż- żewġ kemjoterapiji bl- antraċiklina u bit- tassani jew meta t- tkomplija tat- terapija bl - antraċiklina ma tkunx indikata.
The Committee recommended that Xeloda be given marketing authorisation.
Il- Kumitat irrakkomanda li Xeloda jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Xeloda:
Aktar tagħrif dwar Xeloda:
The European Commission granted a marketing authorisation valid throughout the European Union for Xeloda to Roche Registration Limited on 2 February 2001.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Xeloda lil Roche Registration Limited fit- 2 ta ’ Frar 2001.
The marketing authorisation was renewed on 2 February 2006.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fit- 2 ta ’ Frar 2006.
The full EPAR for Xeloda is available here.
L- EPAR sħiħ għal Xeloda jista ’ jiġi kkonsultat hawn.
EU-number
Isem inventat
Pharmaceutical form
EU/ 1/ 00/ 163/ 001
Route of administration
Pillola miksija b’ rita
Package size
60 pillola
Blisters (PVC/ PE/ PVDC) Blisters (PVC/ PE/ PVDC)
Folji tal (PVC/ PVDC)
60 120
120 pillola
Xeloda 150 mg film-coated tablets.
Xeloda pilloli 150 mg miksija b’ rita.
150 mg capecitabine.
150 mg capecitabine.
15.6 mg anhydrous lactose.
15. 6 mg anhydrous lactose.
Light peach film-coated tablet of biconvex, oblong shape with the marking ‘ 150’ on the one side and ‘ Xeloda’ on the other side.
Pillola miksija b’ rita ta ’ lewn aħmar fl- isfar ċar, ibbużżati fuq iż- żewġ naħat, ta ’ forma oblung bil - marka ‘ 150 ’ fuq naħa waħda u ‘ Xeloda ’ fuq in- naħa l- oħra.
Xeloda is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer (see section 5.1).
Xeloda huwa indikat għall- kura awżiljarja ta ’ pazjenti wara kirurġija ta ’ kanċer tal- kolon ta ’ stadju III (stadu ta ’ Dukes ’ C) (ara sezzjoni 5. 1).
Xeloda is indicated for the treatment of metastatic colorectal cancer (see section 5.1).
Xeloda huwa indikat għall- kura ta ’ kanċer metastatiku tal- kolorektum (ara sezzjoni 5. 1).
Xeloda is indicated for first-line treatment of advanced gastric cancer in combination with a platinum- based regimen (see section 5.1).
Xeloda huwa indikat bħala kura primarja ta ’ kanċer avvanzat fl- istonku f’ taħlita ma ’ programm ta ’ kura ibbażat fuq il- platinu (ara sezzjoni 5. 1).
Xeloda in combination with docetaxel (see section 5.1) is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
Xeloda flimkien ma ’ docetaxel (ara sezzjoni 5. 1) huwa indikat għall- kura ta ’ pazjenti b’ kanċer tas - sider lokalment avvanzat jew metastatiku wara l- falliment ta ’ kemjoterapija ċitotossika.
Previous therapy should have included an anthracycline.
It- terapija preċedenti kellha tinkludi anthracycline.
Xeloda is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline- containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
Xeloda huwa wkoll indikat bħala kura li tittieħed waħidha għall- kura ta ’ pazjenti b’ kanċer tas- sider lokalment avvanzat jew metastatiku wara l- falliment ta ’ taxanes u ta ’ kors ta ’ kemjoterapija li jkun fih anthracycline, jew għal dawk il- pazjenti li għalihom ma jistax jitkompla l- użu ta ’ anthracycline.
Xeloda should only be prescribed by a qualified physician experienced in the utilisation of anti- neoplastic agents.
Xeloda għandu jiġi preskritt biss minn tobba kkwalifikati b’ esperjenza fl- użu ta ’ sustanzi anti - neoplastiċi.
Xeloda tablets should be swallowed with water within 30 minutes after a meal.
Pilloli Xeloda għandhom jinbelgħu ma ’ l- ilma sa 30 minuta wara ikla.
Treatment should be discontinued if progressive disease or intolerable toxicity is observed.
Il- kura għandha titwaqqaf jekk tiġi osservata progressjoni tal- marda jew tossiċità li mhix ittollerata.
Standard and reduced dose calculations according to body surface area for starting doses of Xeloda of 1250 mg/ m2 and 1000 mg/ m2 are provided in tables 1 and 2, respectively.
Kalkulazzjonijiet tad- doża stàndard jew doża mnaqqsa skond l- erja tas- superfiċje tal- ġisem għad- dożi tal- bidu ta ’ Xeloda ta ’ 1250 mg/ m2 u 1000 mg/ m2 hma pprovduti f’ tabelli 1 u 2 rispettivament.
Recommended posology (see section 5.1):
Posoloġija rakkomandata (ara sezzjoni 5. 1):
Monotherapy Colon, colorectal and breast cancer Given as single agent, the recommended starting dose for Xeloda in the adjuvant treatment of colon cancer, in the treatment of metastatic colorectal cancer or of locally advanced or metastatic breast cancer is 1250 mg/ m2 administered twice daily (morning and evening; equivalent to 2500 mg/ m2 total daily dose) for 14 days followed by a 7-day rest period.
Monoterapija Kanċer tal- kolon, tal- kolorektum u tas- sider Mogħti bħala sustanza waħedha, d- doża rakkomandata tal- bidu ta ’ Xeloda fil- kura awżiljarja tal - kanċer tal- kolon, fil- kura ta ’ kanċer tal- kolorektum li mmetastatizza jew ta ’ kanċer tas- sider lokalment avvanzat jew li mmetastatizza hija ta ’ 1250 mg/ m2 mogħtija darbtejn kuljum (fil- għodu u fil- għaxija; ekwivalenti għal doża totali ta ’ kuljum ta ’ 2500 mg/ m2) għal 14- il ġurnata segwit minn
Adjuvant treatment in patients with stage III colon cancer is recommended for a total of 6 months.
Kura awżiljarja f’ pazjenti b’ kanċer tal- kolon ta ’ stadju III hija rakkomandata għal total ta ’ 6 xhur.
The inclusion of biological agents in a combination regimen has no effect on the starting dose of Xeloda.
Terapija kombinata Kanċer tal- kolorektum u ta ’ l- istonku F’ terapija kombinata, id- doża rrakkomandata tal- bidu ta ’ Xeloda għandha titnaqqas għal 800 – 1000 mg/ m2 meta mogħti darbtejn kuljum għal 14- il ġurnata segwit minn perjodu ta ’ waqfien ta ’ 7 t ’ ijiem, jew għal 625 mg/ m2 darbtejn kuljum meta mogħti b’ mod kontinwu (ara sezzjoni 5. 1). l - inklużjoni ta ’ sustanzi bioloġiċi f’ kors ta ’ taħlita ma kellu l- ebda effett fuq id- doża tal- bidu ta ’ Xeloda.
Premedication to maintain adequate hydration and anti-emesis according to the cisplatin summary of product characteristics should be started prior to cisplatin administration for patients receiving the Xeloda plus cisplatin combination.
Medikazzjoni minn qabel biex tinżamm idratazzjoni u effett kontra r- rimettar skond is- sommarju tal - karattersitiċi tal- prodott ta ’ cisplatin għandha tinbeda qabel l- għotja ta ’ cisplatin għall- pazjenti li qed jirċievu taħlita ta ’ Xeloda flimkien ma ’ cisplatin.
Breast cancer In combination with docetaxel, the recommended starting dose of Xeloda in the treatment of metastatic breast cancer is 1250 mg/ m2 twice daily for 14 days followed by a 7-day rest period, combined with docetaxel at 75 mg/ m2 as a 1 hour intravenous infusion every 3 weeks.
Kanċer tas- sider F’ taħlita ma ’ docetaxel, id- doża tal- bidu rakkomandata ta ’ Xeloda fil- kura ta ’ kanċer metastatiku tas - sider hija ta ’ 1250 mg/ m2 darbtejn kuljum għal 14- il jum segwita minn perjodu ta ’ waqfien ta ’ sebat ijiem, flimkien ma ’ 75 mg/ m2 docetaxel mogħti bħala infużjoni fil- vini fuq perjodu ta ’ siegħa kull 3 ġimgħat.
Pre-medication with an oral corticosteroid such as dexamethasone according to the docetaxel summary of product characteristics should be started prior to docetaxel administration for patients receiving the Xeloda plus docetaxel combination.
Medikazzjoni minn qabel b’ corticosteroid orali bħal dexamethasone skond is- sommarju tal - karatteristiċi tal- prodott ta ’ docetaxel għandu jinbeda qabel l- għotja ta ’ docetaxel għall- pazjenti li qed jirċievu taħlita ta ’ Xeloda flimkien ma ’ docetaxel.
Xeloda Dose Calculations
Kalkulazzjonijiet tad- Doża ta ’ Xeloda
Table 1 Standard and reduced dose calculations according to body surface area for a starting dose of Xeloda of 1250 mg/ m2 2 Dose level 1250 mg/ m (twice daily)
Kalkulazzjonijiet għad- doża stàndard jew imnaqqsa skond l- erja tas- superfiċje tal- ġisem, għad- doża tal- bidu ta ’ Xeloda ta ’ 1250 mg/ m2 2 Livell ta ’ doża ta ’ 1250 mg/ m (darbtejn kuljum)
Full dose
Erja tas - Superfiċje
Number of 150 mg tablets and/ or 500 mg tablets per
Doża kull Doża kull għotja Doża kull għotja tal - għotja (mg) 150 mg 500 mg (mg) (mg)
Reduced dose (75%)
2 Ġisem (m)
Reduced dose (50%)
≤1. 26
1250 mg/ m2
1150
administration (each administration to be given morning and evening)
800
950 mg/ m2
1. 27 - 1.
625 mg/ m2
38
Dose per
1650
Dose per
1
Dose per
3
150 mg
1. 39 - 1. 52
500
1800 2 3 1450
mg administration (mg)
39 - 1. 52 1800 2 3
administration (mg)
1. 53 1. 67 1. 79 1. 93 2. 07
≤ 1.26 1.27 - 1.38 1.39 - 1.52 1.53 - 1.66 1.67 - 1.78 1.79 - 1.92 1.93 - 2.06 2.07 - 2.18 ≥ 2.19
- 1. 66 - 1. 78 - 1. 92 - 2. 06 - 2. 18
3 Table 2 Standard and reduced dose calculations according to body surface area for a starting dose of Xeloda of 1000 mg/ m2 2 Dose level 1000 mg/ m (twice daily)
≥
Full dose
2. 19
Reduced dose (75%)
2800 2
Reduced dose (50%)
5
1000 mg/ m2
2150
750 mg/ m2
1450
500 mg/ m2
3 Tabella 2
Body Surface 2
Kalkulazzjonijiet għad- doża stàndard jew imnaqqsa skond l- erja tas- superfiċje tal- ġisem, għad- doża tal- bidu ta ’ Xeloda ta ’ 1000 mg/ m2 2 Livell ta ’ doża ta ’ 1000 mg/ m (darbtejn kuljum)
Dose per
Doża mnaqqsa Doża kollha Numru ta ’ pilloli ta ’ Doża mnaqqsa (75%) 150 mg u/ jew pilloli (50%) ta ’ 500 mg kull 1000 mg/ m2 750 mg/ m2 500 mg/ m2 għotja (kull għotja għandha tingħata filgħodu u filgħaxija)
Dose per
Erja tas - Superfiċje
Dose per
Doża kull Doża kull għotja Doża kull għotja tal - għotja (mg) 150 mg 500 mg (mg) (mg)
Area (m)
2 Ġisem (m)
administration (mg)
≤1. 26
150 mg
1150 1 2 800
500
1.
mg administration (mg)
26 1150 1 2
≤ 1.26 1.27 - 1.38 1.39 - 1.52 1.53 - 1.66 1.67 - 1.78 1.79 - 1.92 1.93 - 2.06 2.07 - 2.18 ≥ 2.19
1. 27 - 1. 38
1150 1300 1450 1600 1750 1800 2000 2150 2300
1300 2 2 1000
1 2 3 4 5 2 - 1 2
27 - 1. 38 1300 2 2
Posology adjustments during treatment:
Aġġustamenti tal- pożoloġija waqt il- kura:
General Toxicity due to Xeloda administration may be managed by symptomatic treatment and/ or modification of the dose (treatment interruption or dose reduction).
Ġenerali It- tossiċità kkawżata meta jittieħed Xeloda tista ’ tiġi kkurata b’ kura sintomatiku u/ jew tibdil fid- doża (interruzzjoni tal- kura jew tnaqqis fid- doża).
Once the dose has been reduced, it should not be increased at a later time.
La darba d- doża tiġi mnaqqsa, m’ għandhiex tiġi miżjuda aktar tard.
For those toxicities considered by the treating physician to be unlikely to become serious or life-threatening, e. g. alopecia, altered taste, nail changes, treatment can be continued at the same dose without reduction or interruption.
Għal dawk it- tossiċitajiet ikkunsidrati mit- tabib li qed jikkura bħala mhux probabbli li jsiru serji jew ta ’ periklu għall- ħajja, e. ż. alopeċja, tibdil fit- togħma, tibdil fid- dwiefer, il- kura tista ’ titkompla bl- istess doża mingħajr tnaqqis jew interruzzjoni.
Patients taking Xeloda should be informed of the need to interrupt treatment immediately if moderate or severe toxicity occurs.
Pazjenti li qed jieħdu Xeloda għandhom jiġu nfurmati dwar il- ħtieġa li titwaqqaf il- kura minnufiħ jekk tidher tossiċità moderata jew severa.
Doses of Xeloda omitted for toxicity are not replaced.
Dożi ta ’ Xeloda maqbużin minħabba t- tossiċità m’ għandhomx jiġu sostitwiti.
The following are the recommended dose modifications for toxicity:
Dawn li ġejjin huma l - modifikazzjonijiet fid- doża rakkomandati f’ każ ta ’ tossiċità:
4 Table 3 Xeloda Dose Reduction Schedule (3-weekly Cycle or Continuous Treatment)
Tabella 3 Skeda tat- Tnaqqis fid- Doża ta ’ Xeloda (Ċiklu ta ’ 3 ġimgħat jew kura kontinwa) Gradi ta ’ tossiċità
Toxicity grades*
Tibdiliet
Dose changes within a treatment cycle
fid- doża f’ ċiklu ta ’ kura
Dose adjustment for next cycle/ dose (% of starting dose)
ċiklu/ doża li jmiss (% tad- doża tal- bidu)
Maintain dose level
Żomm il- livell tad- doża
Maintain dose level
Żomm il- livell tad - doża
• Grade 2
- L- ewwel dehra
Interrupt until resolved to grade 0-1
Interrompi sakemm riżolta għal grad 0- 1
-4th appearance
- It- tieni dehra
Discontinue treatment permanently
- It- tielet dehra
applicable
Ma jgħoddx f’ dan il - każ
• Grade 3
Grad 3
-1st appearance -2nd appearance
- L- ewwel dehra - It- tieni dehra
-3rd appearance
- It- tielet dehra
Discontinue treatment permanently
Waqqaf il- kura għal kollox
Not applicable
Ma jgħoddx f’ dan il -
-1st appearance
Gradi ta ’ tossiċità
Discontinue
* • Grad 4
permanently or
Tibdiliet fid- doża f’ ċiklu ta ’ kura
50%
- L- ewwel dehra
If physician deems it to be in the patient’ s best interest to continue, interrupt until resolved to grade 0-1
Waqqaf għal kollox jew Jekk it- tabib huwa tal- fehma li huwa fl- aħjar interess tal - pazjent li jkompli, interrompi sakemm riżolta għal grad 0- 1
-2nd appearance
- It- tieni dehra
Discontinue permanently
Waqqaf il- kura għal kollox
Not applicable
Ma jgħoddx f’ dan il - każ
*According to the National Cancer Institute of Canada Clinical Trial Group (NCIC CTG) Common Toxicity Criteria (version 1) or the Common Terminology Criteria for Adverse Events (CTCAE) of the Cancer Therapy Evaluation Program, US National Cancer Institute, version 3.0.
* Skond il- Kriterji Komuni tat- Tossiċità (verżjoni 1) tal- Grupp ta ’ Provi Kliniċi ta ’ l- Istitut Nazzjonali tal- Kanċer tal- Kanada (NCIC CTG), jew Il- Kriterji ta ’ Terminoloġija Komuni għall- Avvenimenti Avversi (CTCAE) versjoni 3. 0 tal- Programm ta ’ Valutazzjoni tat- Terapija tal- Kanċer, Istitut Nazzjonali tal- Kanċer ta ’ l- Istati Uniti.
For hand-foot syndrome and hyperbilirubinemia, see section 4.4.
Għas- sindrome ta ’ l- idejn u s- saqajn u iperbilirubinimja, ara sezzjoni 4. 4.
Patients with baseline neutrophil counts of < 1.5 x 109/ L and/ or thrombocyte counts of < 100 x 109/ L should not be treated with Xeloda.
Pazjenti b’ għadd ta ’ newtrofili fil- linja bażi ta ’ < 1. 5 x 109/ L u/ jew b’ għadd ta ’ tromboċiti ta ’ < 100 x 109/ L m’ għandhomx jiġu kkurati b’ Xeloda.
If unscheduled laboratory assessments during a treatment cycle show that the neutrophil count drops below 1.0 x 109/ L or that the platelet count drops below 75 x 109/ L, treatment with Xeloda should be interrupted.
Jekk valutazzjonijiet tal- laboratorju mhux ipprogrammati waqt ċiklu ta ’ kura juru li l- għadd tan- newtrofili waqa ’ taħt 1. 0 x 109/ L jew jekk l - għadd tal- plejtlits jaqa ’ taħt 75 x 109/ L, kura b’ Xeloda għandha titwaqqaf.
Dose modifications for toxicity when Xeloda is used as a 3 weekly cycle in combination with other agents:
Modifikazzjonijiet fid- doża għat- tossiċità meta Xeloda jintuża bħala ċiklu ta ’ 3 ġimgħat f’ taħlita ma ’ sustanzi oħra:
Dose modifications for toxicity when Xeloda is used as a 3 weekly cycle in combination with other agents should be made according to Table 3 above for Xeloda and according to the appropriate summary of product characteristics for the other agent(s).
Modifikazzjonijiet fid- doża għat- tossiċità meta Xeloda jintuża bħala ċiklu ta ’ 3 ġimgħat f’ taħlita ma ’ sustanzi oħra għandhom isiru skond Tabella 3 fuq għal Xeloda u skond is- sommarju tal- karatteristiċi tal- prodott xieraq tas- sustanza( i) l- oħra.
At the beginning of a treatment cycle, if a treatment delay is indicated for either Xeloda or the other agent(s), then administration of all agents should be delayed until the requirements for restarting all drugs are met.
Fil- bidu taċ- ċiklu tal- kura, jekk ikun indikat dewmien fil- kura għal Xeloda jew għas- sustanza( i) l- oħra, l- għotja tas- sustanzi kollha għandha tiġi ttardjata sakemm jintlaħqu il- ħtiġijiet għal bidu mill- ġdid tal - mediċini kollha.
During a treatment cycle for those toxicities considered by the treating physician not to be related to Xeloda, Xeloda should be continued and the dose of the other agent should be adjusted according to the appropriate Prescribing Information.
Waqt ċiklu ta ’ kura għal dawk it- tossiċitajiet ikkunsidrati mit- tabib li qed jikkura li mhux relatati ma ’ Xeloda, Xeloda għandu jitkompla u d- doża tas- sustanza l- oħra għandha tiġi aġġustata skond it- Tagħrif xieraq ta ’ kif Tippreskrivi.
If the other agent(s) have to be discontinued permanently, Xeloda treatment can be resumed when the requirements for restarting Xeloda are met.
Jekk is- sustanza( i) l- oħra ser ikollhom jiġu mwaqqfa għal kollox, kura b’ Xeloda tista ’ titkompla meta jintlaħqu l- ħtiġijiet għal bidu mill- ġdid ta ’ Xeloda.
This advice is applicable to all indications and to all special populations.
Dan il- parir jgħodd għall- indikazjonijiet kollha u għall- popolazzjonijiet speċjali kollha.
5 Dose modifications for toxicity when Xeloda is used continuously in combination with other agents:
Modifikazzjonijiet fid- doża għal tossiċitajiet meta Xeloda jintuża kontinwament f’ taħlita ma ’ sustanzi oħra:
Dose modifications for toxicity when Xeloda is used continuously in combination with other agents should be made according to Table 3 above for Xeloda and according to the appropriate summary of product characteristics for the other agent(s).
Modifikazzjonijiet fid- doża għal tossiċitajiet meta Xeloda jintuża kontinwament f’ taħlita ma ’ sustanzi oħra għandhom isiru skond Tabella 3 fuq għal Xeloda u skond is- sommarju tal- karatteristiċi tal - prodott xieraq tas- sustanza( i) l- oħra.
Posology adjustments for special populations:
Aġġustamenti fil- pożoloġija għall- popolazzjonijiet speċjali:
Hepatic impairment: insufficient safety and efficacy data are available in patients with hepatic impairment to provide a dose adjustment recommendation.
Indeboliment tal- fwied: m’ hemmx informazzjoni biżżejjed dwar is- sigurtà u l- effikaċja f’ pazjenti b’ indeboliment tal- fwied biex tipprovdi rakkomandazzjoni dwar l- aġġustament fid- doża.
No information is available on hepatic impairment due to cirrhosis or hepatitis.
M’ hemmx tagħrif dwar indeboliment tal- fwied minħabba ċirrosi jew epatite.
Renal impairment:
5 Indeboliment tal- kliewi:
Xeloda is contraindicated in patients with severe renal impairment (creatinine clearance below 30 ml/ min [Cockcroft and Gault] at baseline).
Xeloda huwa kontra- indikat f’ pazjenti b’ indeboliment serju tal- kliewi (tneħħija tal- krejatinina taħt it- 30 ml/ min [Cockcroft u Gault] fil- linja bażi).
The incidence of grade 3 or 4 adverse reactions in patients with moderate renal impairment (creatinine clearance 30-50 ml/ min at baseline) is increased compared to the overall population.
L- inċidenza ta ’ reazzjonijiet avversi ta ’ grad 3 jew 4 f’ pazjenti b’ indeboliment moderat tal- kliewi (tneħħija tal - krejatinina ta ’ 30- 50 ml/ min fil- linja bażi) hija ikbar meta mqabba mal- populazzjoni totali.
In patients with moderate renal impairment at baseline, a dose reduction to 75% for a starting dose of 1250 mg/ m2 is recommended.
F’ pazjenti b’ indeboliment moderat tal- kliewi fil- linja bażi, tnaqqis fid- doża ta ’ 75% għal doża tal- bidu ta ’ 1250 mg/ m2 huwa rakkomandat.
In patients with moderate renal impairment at baseline, no dose reduction is required for a starting dose of 1000 mg/ m2.
F’ pazjenti b ’ indeboliment moderat tal- kliewi fil- linja bażi, m’ hemm bżonn ta ’ l- ebda tnaqqis fid- doża għad- doża tal- bidu ta ’ 1000 mg/ m2.
In patients with mild renal impairment (creatinine clearance 51-80 ml/ min at baseline) no adjustment of the starting dose is recommended.
F’ pazjenti b’ indeboliment ħafif tal- kliewi (tneħħija tal- krejatinina ta ’ 51- 80 ml/ min fil- linja bażi) mhux rakkomandat li jsir l- ebda aġġustament fid- doża tal- bidu.