qanastek/EMEA-V3 huggingface dataset:
(See Storing Your BYETTA Pen in Section 1 of this user manual for more information.) • When it is time for your next routine dose, go to Section 3, Step 1, and repeat Steps 1 - 7.
(Għal aktar informazzjoni, ara Il- Ħażna Tal- Pinna ta ’ BYETTA Tiegħek f’ Sezzjoni 1 ta ’ dan il- manwal) • Meta jasal il- waqt għad- doża ta ’ rutina li jmiss, mur f’ Sezzjoni 3, Proċedura 1, u rrepeti l - Proċeduri 1 - 7.
COMMONLY ASKED QUESTIONS
Sezzjoni 4 MISTOQSIJIET MAGĦMULA TA ’ SPISS
Do I need to do the New Pen Setup before every dose? • No.
Għandi għalfejn nagħmel it- Tħejija ta 'Pinna Ġdida qabel kull doża? • Le.
The New Pen Setup is done only once, just before each new pen is used for the first time. • The purpose of the setup is to make sure that your BYETTA pen is ready to use for the next 30 days. • If you repeat the New Pen Setup before each routine dose, you will not have enough BYETTA for 30 days.
It- Tħejija ta 'Pinna Ġdida issir darba biss, eżatt qabel ma tiġi użata għall- ewwel darba kull pinna ġdida. • L- iskop tat- tħejija hu li tiżgura li l- pinna BYETTA tkun lesta biex tintuża għat- 30 ġurnata li jmiss. • Jekk tirrepeti t- Tħejija ta' Pinna Ġdida qabel kull doża ta 'rutina ma jkollokx biżżejjed BYETTA għal 30 ġurnata.
The small amount of BYETTA used in the New Pen Setup will not affect the 30-day supply of BYETTA.
L- ammont żgħir ta 'BYETTA li jintuża fit- Tħejija ta' Pinna Ġdida mhux ser jaffettwa l- provvista ta 'BYETTA għal 30 ġurnata.
Why are there air bubbles in the cartridge? • A small air bubble is normal.
Għaliex hemm il- bżieżaq ta 'l- arja fl- iskartoċċ? • Huwa normali li jkun hemm bużżieqa żgħira ta' l- arja.
It will not harm you or affect your dose. • If the pen is stored with a needle attached, air bubbles may form in the cartridge.
Din mhix ser tagħmillek ħsara jew taffettwalek id- doża. • Jekk taħzen il- pinna b' labra mwaħħla, jistgħu jiffurmaw bżieżaq ta 'l- arja fl- iskartoċċ.
Do not store the pen with the needle attached.
Taħżinx il- pinna bil- labra mwaħħla.
What should I do if BYETTA does not come out of the needle tip after four tries during New Pen Setup? • Remove the needle by carefully putting the outer needle shield back over the needle.
X' għandi nagħmel jekk waqt it- Tħejija ta 'Pinna Ġdida BYETTA ma joħroġx mill- ponta tal - labra wara li nkun ippruvajt għal erba' darbiet? • Neħħi l- labra billi terġa 'tpoġġi bil- mod fuqha l- għatu ta' barra tal- labra.
Unscrew and dispose of properly. • Attach a new needle and repeat New Pen Setup, Steps B – E, in Section 2 of this user manual.
Ħoll u armi kif suppost. • Waħħal labra ġdida u rrepeti t- Tħejija ta 'Pinna Ġdida, Proċeduri B – E, f' Sezzjoni 2 ta' dan il- manwal.
Once you see several drops or a stream of liquid coming out of the tip of the needle, the setup is complete.
Malli tara li mill- ponta tal- labra ħerġin diversi qtar jew nixxiegħa ta 'likwidu, it - tħejija tkun kompleta.
Why do I see BYETTA leaking from my needle after I have finished my injection?
Għaliex nara li BYETTA qed inixxi mil- labra wara li nlesti l- injezzjoni?
It is normal for a single drop to remain on the tip of your needle after your injection is complete.
Huwa normali li tibqagħlek qatra waħda fuq il- ponta tal- labra wara li l- injezzjoni tkun kompleta.
If you see more than one drop: • You may not have received your full dose.
Jekk tara aktar minn qatra waħda: • Tista 'ma tkunx ħadt id- doża kollha.
Do not inject another dose.
Tinjettax doża oħra.
Consult with your healthcare professional about how to handle a partial dose. • To prevent this, for your next dose, firmly push and hold the injection button in and slowly count to 5 (see Section 3, Step 4:
Kellem lill- professjonist/ a tal- kura tas- saħħa tiegħek dwar kif għandek tagħmel minħabba doża parzjali. • Biex tevita dan, għad- doża li jmissek tieħu, agħfas u żomm sew il- buttuna ta 'l- injezzjoni u għodd bil- mod sa 5 (ara Sezzjoni 3, Proċedura 4:
Inject the Dose).
Injetta d- Doża).
What do the arrows mean?
X’ jfissru l- vleġeġ?
The arrows mean you are ready for the next step.
Il- vleġeġ ifissru li inti lest għall- proċedura li jmiss.
These turn the dose knob in the next step.
Dawn il- vleġeġ tiġbed jew iddawwar is- selettur tad- doża fil- proċedura li jmiss.
This symbol ready to reset.
Dan is- simbolu
arrows means the dose knob
juru d- direzzjoni biex jfisser li s- selettur
show the direction to pull or is pushed in and the pen is
tad- doża huwa magħfus ’ il ġewwa u l- pinna hija lesta biex terġa ’ tiġi ssettjata.
How can I tell when the injection is complete?
Kif inkun naf li l- injezzjoni tkun kompleta?
The injection is complete when:
L- injezzjoni tkun kompleta meta:
• You have firmly pushed the injection button in all the way until it stops and • You have slowly counted to 5 while you are still holding the injection button in and the needle is still in your skin and •
50 • Tkun għafast sew il- buttuna ta 'l- injezzjoni kollha ’ l ġewwa sakemm tieqaf u • Tkun għoddejt bil- mod sa 5 filwaqt li tkun għadek qed tagħfas il- buttuna ta' l- injezzjoni u l - labra tkun għadha fil- ġilda u •
The
Is -
is in the centre of the dose window.
ikun fin- nofs tat- tieqa tad- dożaġġ.
Where should I inject BYETTA?
Fejn għandi nagħmel l- injezzjoni ta ’ BYETTA?
BYETTA should be injected into your abdomen, thigh, or upper arm using the injection technique recommended by your healthcare professional.
BYETTA għandu jiġi injettat fl- addome, fil- koxxa jew fil- parti ta 'fuq tad- driegħ tiegħek billi tuża t - teknika ta' injezzjoni rrakkomandata mill- professjonist/ a tal- kura tas- sahħa tiegħek.
Front Back
Quddiem
What if I cannot pull, turn, or push the dose knob?
X' nagħmel jekk ma nkunx nista 'niġbed, indawwar jew nagħfas is- selettur tad- doża?
Check the symbol in the dose window.
Iċċekkja s- simbolu fit- tieqa tad- dożaġġ.
Follow the steps next to the matching symbol.
Segwi l- proċeduri li jidhru ħdejn is- simbolu korrispondenti.
If is in the dose window:
fit- tieqa tad- dożaġġ:
Pull the dose knob out until
Iġbed is- selettur tad- doża ’ l barra sakemm tara s -
appears.
Jekk tara s -
If is in the dose window and the dose knob will not turn: • The cartridge in your BYETTA pen may not have enough liquid to deliver a full dose.
• L- iskartoċċ fil- pinna ta 'BYETTA jista' ma jkollux biżżejjed likwidu biex tingħata doża sħiħa.
A small amount of BYETTA will always remain in the cartridge.
Dejjem ser jibqa 'ammont żgħir ta' BYETTA fl- iskartoċċ.
If the cartridge contains a small amount or looks empty, obtain a new BYETTA pen.
Jekk l- iskartoċċ fih ammont żgħir ta 'BYETTA jew jidher vojt, uża pinna ta' BYETTA ġdida.
If
Jekk s - jingħafas:
and part of the
u parti min -
are in the dose window and the dose knob cannot be pushed in:
qegħdin fit- tieqa tad- dożaġġ u s- selettur tad- doża ma jistax
• The dose knob was not turned all the way.
• Is- selettur tad- doża ma ġiex imdawwar kollu.
Continue turning the dose knob clockwise until is in the centre of the dose window.
Kompli dawwar is- selettur tad- doża lejn in- naħa
If part of
Jekk parti min - jingħafas:
and part of
u parti mis -
• The needle may be clogged, bent, or incorrectly attached. • Attach a new needle.
• Il- labra tista 'tkun misduda, mgħawġa jew imwaħħla ħażin. • Waħħal labra ġdida.
Make sure needle is on straight and screwed on all the way. • Firmly push the injection button in all the way.
Kun żgur li l- labra tkun imwaħħla dritta u ssikkata sew. • Agħfas sew il- buttuna ta 'l- injezzjoni kollha ’ l ġewwa.
BYETTA should come from needle tip.
BYETTA għandu joħroġ mill- ponta tal - labra.
If is in the dose window and the dose knob will not turn: • The injection button was not pushed in all the way and a complete dose was not delivered.
fit- tieqa tad- dożaġġ u s- selettur tad- doża ma jdurx: ta 'l- injezzjoni ma ġietx magħfusa sa ġewwa nett u ma ngħatatx doża kompleta.
Consult with your healthcare professional about how to handle a partial dose. • Follow these steps to reset your pen for your next injection:
Kellem lill- professjonist/ a tal- kura tas- saħħa tiegħek dwar kif għandek tagħmel minħabba doża parzjali • Segwi dawn il- proċeduri li gejjin sabiex tissettja mill- ġdid il- pinna tiegħek għall- injezzjoni li jmiss:
- Firmly push the injection button in all the way until it stops.
- Agħfas sew il- buttuna ta 'l- injezzjoni kollha ’ l ġewwa sakemm tista ’.
Keep holding the injection button
Ibqa 'agħfas il- buttuna
in and slowly count to 5.
ta 'l- injezzjoni u għodd bil- mod sa 5.
Then turn the dose knob clockwise until window.
Imbagħad dawwar is- selettur tad- doża lejn in- naħa tal -
appears in the dose
lemin sakemm is -
- If you cannot turn the dose knob, the needle may be clogged.
- Jekk ma tkunx tista 'ddawwar is- selettur tad- doża, il- labra tista' tkun misduda.
Replace the needle and repeat
Ibdel il- labra u
the step above. • For your next dose, be sure to firmly push and hold the injection button in and slowly count to 5 before removing needle from skin.
rrepeti l- proċedura ta 'hawn fuq. • Għad- doża li jmissek tieħu, kun żgur li tagħfas u żżom sew il- buttuna ta' l- injezzjoni ’ l ġewwa u għodd bil- mod sa 5 qabel ma tneħħi l- labra mill- ġilda.
Please see the accompanying Package Leaflet.
Jekk jogħġbok ara l- Fuljett ta 'Tagħrif mehmuż.
For additional information contact your healthcare professional.
Għal aktar tagħrif kellem lill- professjonist/ a tal- kura tas- saħħa tiegħek.
51 PEN USER MANUAL
52 MANWAL GĦAL MIN SE JAGĦMEL UŻU MILL- PINNA
BYETTA 10 micrograms solution for injection, pre-filled pen (exenatide)
BYETTA 10 mikrogrammi soluzzjoni għall- injezzjoni, pinna mimlija għal- lest (exenatide)
Do not reuse needles. • Remove the needle immediately after each injection.
53 • Neħħi l- labra minnufih wara kull injezzjoni.
52 How do I throw away my needles? • Throw away used needles in a puncture-resistant container or as recommended by your healthcare professional. • Do not throw away the pen with a needle attached.
Kif narmi l- labar tiegħi? • Armi labar użati f' kontenitur reżistenti għall- perforazzjoni jew kif irrakkomandat mill - professjonist/ a tal- kura tas- saħħa tiegħek. • Tarmix il- pinna bil- labra mwaħħla.
53 BYETTA PEN PARTS
54 PARTIJIET TAL- PINNA TA ’ BYETTA
DOSE WINDOW SYMBOLS ready to pull dose knob out ready to turn to dose position ready to inject 10 µg
SIMBOLI TAT- TIEQA TAD- DOŻA lest biex toħroġ is- selettur tad- doża ’ l barra lest biex iddawwar għall- pożizzjoni tad- doża lest biex tinjetta 10 µg
• Wash hands prior to use. • Check pen label to make sure it is your 10 µg pen. • Pull off the blue pen cap.
• Aħsel idejk qabel l- użu. • Iċċekkja t- tikketta tal- pinna biex tkun żgur li hija l- pinna ta ’ 10 µg tiegħek. • Neħħi l- kappa blu tal- pinna.
54 • Pull off outer needle shield.
55 • Neħħi l- għatu ta ’ barra tal- labra.
Turn dose knob clockwise until it stops at in the centre of the dose window.
Dawwar is- selettur tad- doża lejn in- naħa tal- lemin sakemm jieqaf fin - n- numru 10 bil- linja taħtu qiegħed fiċ- ċentru tat- tieqa tad- dożaġġ.
Make sure that the 10 with the line under it is
Aċċerta ruħek li
STEP D Prepare the Pen
56 PROĊEDURA D Ipprepara l- Pinna
55 • Point the needle of the pen up and away from you.
• Ipponta l- labra tal- pinna ’ l fuq u l- bogħod minnek.
PUSH & HOLD • Use thumb to firmly push the injection button in until it stops, then continue holding the injection button in while slowly counting to 5. • If you do not see a stream or several drops come from the needle tip, repeat Steps C & D.
AGĦFAS U ŻOMM • Permezz tas- saba ’ l kbir, agħfas sew il ġewwa l- buttuna ta ’ l- injezzjoni sakemm tista ’, imbagħad kompli żomm il- buttuna ta ’ l- injezzjoni ’ l ġewwa waqt li tgħodd bil- mod sa 5. • Jekk mill- ponta tal- labra ma tarax nixxiegħa ta ’ likwidu jew ħafna qtar, irrepeti l - Proċeduri Ċ & D.
Section 3.
57 Sezzjoni 3.
STEP 1 Check the Pen
PROĊEDURA 1 Iċċekkja l- Pinna
56 • Wash hands prior to use. • Check pen label to make sure it is your 10 µg pen. • Pull off the blue pen cap.
• Aħsel idejk qabel l- użu. • Iċċekkja t- tikketta tal- pinna biex tkun żgur li hija l- pinna ta ’ 10 µg tiegħek. • Neħħi l- kappa blu tal- pinna.
• Pull off inner needle shield and throw away.
58 • Neħħi l- għatu ta ’ ġewwa tal- labra u armih.
STEP 3 Dial the Dose
PROĊEDURA 3 Isselezzjona d- Doża
If not, turn dose knob clockw ise until it stops and the w indow.
Jekk le, dawwar is- selettur tad- doża lejn in- naħa
PUSH & HOLD • Use thumb to firmly push injection button in until it stops, then continue holding the injection button in while slowly counting to 5 in order to get a full dose. • Remove needle from skin.
59 AGĦFAS U ŻOMM • Permezz tas- saba ’ l kbir, agħfas sew il ġewwa l- buttuna ta ’ l- injezzjoni sakemm tista ’, imbagħad kompli żomm il- buttuna ta ’ l- injezzjoni ’ l ġewwa waqt li tgħodd bil- mod sa 5, sabiex tieħu d- doża kollha. • Neħħi l- labra mill- ġilda.
• Throw away needles in a puncture-resistant container or as recommended by your healthcare professional.
60 • Armi l- labar f' kontenitur reżistenti għall- perforazzjoni jew kif irrakkomandat mill - professjonist/ a tal- kura tas- saħħa tiegħek.
59 Section 4.
Sezzjoni 4.
COMMONLY ASKED QUESTIONS
MISTOQSIJIET MAGĦMULA TA ’ SPISS
Why do I see BYETTA leaking from my needle after I have fin ished my injection?
Għaliex nara li BYETTA qed inixxi mil- labra wara li nlesti l- injezzjoni?
• You have firmly pushed the injection button in all the way until it stops and • You have slowly counted to 5 while you are still holding the injection button in and the needle is still in your skin and •
61 • Tkun għafast sew il- buttuna ta 'l- injezzjoni kollha’ l ġewwa sakemm tieqaf u • Tkun għoddejt bil- mod sa 5 filwaqt li tkun għadek qed tagħfas il- buttuna ta' l- injezzjoni u l - labra tkun għadha fil- ġilda u •
If is in the dose window and the dose knob will not turn: • The injection button was not pushed in all the way and a complete dose was not delivered.
• Il- buttuna ta 'l- injezzjoni ma ġietx magħfusa sa ġewwa nett u ma ngħatatx doża kompleta.
Consult with your healthcare professional about how to handle a partial dose. • Follow these steps to reset your pen for your next injection:
Kellem lill- professjonist/ a tal- kura tas- saħħa tiegħek dwar kif għandek tagħmel minħabba doża parzjali • Segwi dawn il- proċeduri li ġejjin sabiex tissettja mill- ġdid il- pinna tiegħek għall- injezzjoni li jmiss:
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
RAPPORT TAL- VALUTAZZJONI PUBBLIKA EWROPEA (EPAR)
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk trid aktar informazzjoni abbażi tar- rakkomandazzjonijiet ta ’ CHMP, aqra d - Diskussjoni Xjentifika (ukoll parti mill- EPAR
What is Caelyx?
X' inhu Caelyx?
Caelyx is concentrate to be made up into a solution for infusion (drip into a vein).
Caelyx huwa konċentrat biex jitħallat f' soluzzjoni għal infużjoni (drip ġol- vina).
It contains the active substance doxorubicin hydrochloride (2 mg/ ml).
Huwa fih is- sustanza attiva doxorubicin hydrochloride (2 mg/ ml).
What is Caelyx used for?
Għal xiex jintuża Caelyx?
Caelyx is used to treat the following types of cancer: • metastatic breast cancer in patients at risk of heart problems. ‘ Metastatic’ means the cancer has spread to other parts of the body.
'Metastatiku' tfisser li l- kanċer infirex għal partijiet oħra tal- ġisem.
Caelyx is used on its own for this disease; • advanced ovarian cancer (cancer of the ovary) in women whose previous treatment including a platinum-based anticancer medicine has stopped working; • Kaposi’ s sarcoma (a cancer of the blood vessels) in patients with acquired immune deficiency syndrome (AIDS) who have very damaged immune systems and extensive sarcoma on the skin, the moist body surfaces or the internal organs.
Għal din il- marda Caelyx jintuża waħdu; • Kanċer ta 'l- ovarji fi stadju avvanzat (kanċer ta' l- ovarji) f' nisa li t- trattament ta 'qabel tagħhom inkluda mediċina kontra l- kanċer abbażi tal- platinu li kellhiex aktar effett; • Sarkoma ta' Kaposi (kanċer tal- vażi tad- demm) f' pazjenti bis- sindromu minn immunodefiċjenza akkwiżita (AIDS) li għandhom sistema immunitarja ferm imħassra u sarkoma estensiva fuq il - ġilda, l- uċuħ umidi tal- ġisem jew ta 'l- organi interni.
It is used when other treatments have stopped working or were not tolerated; • multiple myeloma (a cancer of the cells in the bone marrow), in patients with progressive disease who have received at least one other treatment in the past and are unsuitable for a bone marrow transplant.
Huwa jintuża meta trattamenti oħrajn waqfu jkollhom effett jew mhumiex tollerati; • Mjeloma multipla (kanċer taċ- ċelloli tal- mudullun), f' pazjenti b' mard progressiv li rċevew ta 'l - anqas trattament ieħor fil- passat jew li mhumiex tajbin għal trapjant tal- mudullun.
Caelyx is used in combination with bortezomib (another anticancer medicine).
Caelyx jintuża f' kombinazzjoni ma 'bortezomib (mediċina oħra kontra l- kanċer).
How is Caelyx used?
Kif jintuża Caelyx?
Caelyx should be given under the supervision of a doctor who is qualified in the use of cytotoxic (cell- killing) medicines.
Caelyx għandu jingħata taħt sorveljanza ta 'tabib li jkun ikkwalifikat fl- użu ta' mediċini ċitotossiċi (li joqtlu ċ- ċelloli).
It cannot be interchanged with other medicines containing doxorubicin hydrochloride.
Ma jistax jiġi sostitwit b' mediċini oħra li fihom doxorubicin hydrochloride.
The recommended starting dose of Caelyx for breast or ovarian cancer is 50 mg per square metre body surface area (calculated using the patient ’ s height and weight) every four weeks for as long as the disease does not get worse and the patient can tolerate the treatment.
Id- doża rrakkomandata tal- bidu ta 'Caelyx għal kanċer tas- sider jew ta' l- ovarji hija 50 mg kull metru kwadru ta 'piż tal- ġisem (ikkalkulat bl- użu tat- tul u l- piż tal- pazjent) kull erba' ġimgħat sakemm il - marda ma tmurx għall- agħar u diment li l- pazjent jista 'jittollera t- trattament.
For Kaposi’ s sarcoma, the dose is 20 mg/ m2 every two to three weeks for two to three months, and for multiple myeloma, it is 30 mg/ m2 on day four of each three-week cycle of bortezomib treatment, for as long as the patient continues to benefit from the treatment and can tolerate it.
Għal sarkoma ta 'Kaposi, id- doża hija 20 mg/ m2 kull ġimagħtejn sa tlieta għal xahrejn sa tliet xhur, u għal mjeloma multipla, hija 30 mg/ m2 f' jum numru erbgħa ta' kull ċiklu ta 'tliet ġimgħat ta' trattament bil- bortezomib, għal tul ta 'żmien sakemm il- pazjent jibqa' jibbenefika mit- trattament u jista 'jittollerah.
Treatment should be stopped or the dose reduced in patients who experience certain side effects or who have liver problems.
It- trattament għandu jieqaf jew id- doża titnaqqas f' pazjenti li jesperjenzaw ċerti effetti sekondarji jew li għandhom problemi tal- fwied.
Caelyx is not recommended for patients whose spleen has been removed or for children.
Caelyx mhuwiex rakkomandat għal pazjenti li tneħħitilhom il- milsa jew għat- tfal.
For more information, see the Package Leaflet.
Għal aktar tagħrif, ara l- Fuljett ta 'Tagħrif.
How does Caelyx work?
Kif jaħdem Caelyx?
The active substance in Caelyx, doxorubicin hydrochloride, is a cytotoxic medicine that belongs to the group ‘ anthracyclines’.
Is- sustanza attiva f' Caelyx, doxorubicin hydrochloride, hija mediċina ċitotossika li tappartjeni għall - grupp 'antraċiklini'.
It works by interfering with the DNA within cells, preventing them from making more copies of DNA and making proteins.
Hija taħdem billi tintervjeni fid- DNA fi ħdan iċ- ċelloli, timpedixxi r- riproduzzjoni ta 'DNA u l- produzzjoni tal- proteini.
This means that cancer cells cannot divide and eventually die.
Dan ifisser li ċ- ċelloli tal- kanċer ma jistgħux jinqasmu u eventwalment imutu.
Caelyx accumulates in areas in the body where the blood vessels have an abnormal shape, such as within tumours, where its action is concentrated.
Caelyx jakkumula f' żoni tal- ġisem fejn iċ- ċelloli għandhom forma anomala, bħal fi ħdan it- tumuri, fejn l- azzjoni tiegħu hija kkonċentrata.
Doxorubicin hydrochloride has been available since the 1960s.
Doxorubicin hydrochloride ilu disponibbli sa mis- snin Sittin.
In Caelyx, it is contained in ‘ pegylated liposomes’ (tiny fatty spheres that are coated with a chemical called polyethylene glycol).
F' Caelyx, jinsab ġewwa lipożomi peġilati (pegylated liposomes, sferi żgħar li fihom ix- xaħam miksijin b' sustanza kimika msejħa polyethylene glycol).
This reduces the rate at which the active substance is broken down, allowing it to circulate in the blood for longer.
Dan inaqqas ir- rata ta 'tkissir tas- sustanza attiva, u jħalliha tiċċirkola fid- demm għal żmien itwal.
It also reduces its effects on non-cancer tissues and cells, so it is less likely to cause some side effects.
Inaqqas ukoll l- effetti tiegħu fuq tessuti u ċelloli mhux tal- kanċer, għalhekk x' aktarx jikkaġuna inqas effetti sekondarji.
How has Caelyx been studied?
Kif ġie studjat Caelyx?
Caelyx has been studied in a total of 2,512 patients in seven main studies.
Caelyx ġie studjat f' total ta '2, 512- il pazjent f' seba' studji ewlenin.
For metastatic breast cancer, Caelyx has been compared with standard doxorubicin in one main study involving 509 women.
Għal kanċer metastatikutas- sider, Caelyx tqabbel ma 'doxorubicin standard fi studju wieħed ewlieni li involva 509 nisa.
For advanced ovarian cancer, Caelyx has been compared with topotecan (another anticancer medicine) in one study involving 474 women who had received platinum-based chemotherapy in the past.
Għal kanċer ta 'l- ovarji fi stadju avvanzat, Caelyx tqabbel ma' topotecan (mediċina oħra kontra l - kanċer) fi studju wieħed li nvolva 474 mara li fil- passat kienu rċevew kemjoterapija bbażata fuq il - platinu.
For AIDS-related Kaposi’ s sarcoma, the effectiveness of Caelyx was studied in two main studies involving 384 patients, including 77 who had received treatment before.
Għal sarkoma ta 'Kaposi relatata ma' l- AIDS, l- effikaċja ta 'Caelyx ġiet studjata f' żewġ studji ewlenin li involvew 384 pazjent, inklużi 77 li kienu rċevew trattament qabel.
Further studies compared Caelyx with the combination of doxorubicin, bleomycin and vincristine (other anticancer medicines) in 258 patients and with the combination of bleomycin and vincristine in 241 patients.
Aktar studji qabblu Caelyx ma 'kombinazzjoni ta' doxorubicin, bleomycin u vincristine (mediċini oħra kontra l- kanċer) f' 258 pazjent u bil- kombinazzjoni ta 'bleomycin u vincristine f' 241 pazjent.
For multiple myeloma, the effectiveness of the combination of Caelyx and bortezomib was compared with that of bortezomib alone in 646 patients.
Għal mjeloma multipla, l- effikaċja tal- kombinazzjoni ta 'Caelyx u bortezomib tqabblet ma' dik ta 'bortezomib waħdu f' 646 pazjent.
The main measure of effectiveness was time until the disease got worse or, for Kaposi’ s sarcoma, the number of patients who responded to treatment.
Il- kejl ewlieni ta 'l- effikaċja kien iż- żmien sakemm il- marda marret għall- agħar jew, għal sarkoma ta' Kaposi, in- numru ta 'pazjenti li rrispondew għat- trattament.
What benefit has Caelyx shown during the studies?
X' benefiċċju wera Caelyx waqt l- istudji?
In the treatment of breast cancer, Caelyx was as effective as standard doxorubicin: the time until the disease got worse was around 7.5 months in both groups.
Fil- kura tal- kanċer tas- sider, Caelyx kien effikaċi daqs doxorubicin standard: iż- żmien sakemm il - marda marret għall- agħar kien ta 'madwar 7 xhur u nofs fiż- żewġ gruppi.
However, patients receiving Caelyx were less likely to experience heart problems.
Madankollu, pazjenti li kienu qegħdin jirċievu Caelyx x' aktarx esperjenzaw inqas problemi tal- qalb.
For ovarian cancer, Caelyx was as effective as topotecan in extending time until the disease got worse.
Għal kanċer ta 'l- ovarji, Caelyx kien effikaċi daqs topotecan f' li jestendi ż- żmien sakemm il- marda tmur għall- agħar.
For Kaposi’ s sarcoma, around 70% of the patients had a complete or partial response to treatment, with similar results in the study of patients who had been treated before.
Għal sarkoma ta 'Kaposi, madwar 70% tal- pazjenti kellhom reazzjoni kompluta jew parzjali għat - trattament, b' riżultati simili fl- istudju ta' pazjenti li kienu ġew ittrattati qabel.
The additional studies showed that Caelyx was also more effective than the comparator combinations.
L- istudji addizzjonali wrew li Caelyx kien aktar effikaċi mill- kombinazzjonijiet ta 'tqabbil.
For multiple myeloma, adding Caelyx to bortezomib increased the time until the disease got worse from 6.5 to 9.3 months.
Għall- mjeloma multipla, iż- żieda ta 'Caelyx ma' bortezomib żiedet iż- żmien sakemm il- marda marret għall- agħar minn 6. 5 sa 9. 3 xhur.
What is the risk associated with Caelyx?
X' inhu r- riskju assoċjat ma 'Caelyx?
The side effects with Caelyx depend on the type of cancer being treated.
L- effetti sekondarji b' Caelyx jiddependu fuq it- tip ta 'kanċer li jkun qiegħed jiġi ttrattat.
The most common side effect seen in all types of cancer (in more than 1 patient in 10) is nausea (feeling sick).
L- aktar effetti sekondarji komuni li jidhru fit- tipi kollha ta 'kanċers (f' aktar minn pazjent 1 minn kull 10) huma nawżea (dardir).
Other very common side effects include palmar-plantar erythrodysaesthesia syndrome (redness and pain on the hands and feet), vomiting, stomatitis (inflammation of the lining of the mouth), rash, asthenia (weakness), low blood cell counts, anorexia (loss of appetite), alopecia (hair loss), fatigue (tiredness), diarrhoea, constipation and mucositis (inflammation of the mouth and throat).
Effetti sekondarji komuni ħafna oħrajn jinkludu sindromu ta 'eritrodisestesija palmo - plantari (ħmura u wġigħ fuq l- idejn u s- saqajn), rimettar, stomatite (infjammazzjoni tal- kisi tal- ħalq), raxx, astenija (dgħjufija), għadd baxx taċ- ċelloli tad- demm, anoressija (nuqqas ta' aptit), alopeċja (telf ta 'xagħar), għeja kbira, dijarrea, stitikezza u mukożite (infjammazzjoni tal- ħalq u l- gerżuma).
For the full list of all side effects reported with Caelyx, see the Package Leaflet.
Għal - lista sħiħa ta 'l- effetti sekondarji kollha rrapportati b' Caelyx, ara l- Fuljett ta' Tagħrif.
Caelyx should not be used in people who may be hypersensitive (allergic) to doxorubicin hydrochloride or any of the other ingredients.
Caelyx m' għandux jintuża f' nies li jistgħu jkunu ipersensittivi (allerġiċi) għal doxorubicin hydrochloride jew għal kwalunkwe sustanza oħra tiegħu.
Caelyx must not be used to treat Kaposi’ s sarcoma that could be treated effectively with ‘ local ’ treatments that only affect the site of the tumour or with whole-body alfa interferon treatment.
Caelyx m' għandux jintuża biex jittratta s - sarkoma ta 'Kaposi li tista' tiġi ttrattata b' mod effikaċi bi trattamenti 'lokali' li jaffettwaw biss is- sit tat - tumur jew bi trattament alfa- interferon li jaffettwa l- ġisem kollu.
Why has Caelyx been approved?
Għalfejn ġie approvat Caelyx?
The Committee for Medicinal Products for Human Use (CHMP) decided that Caelyx’ s benefits are greater than its risks for the treatment of metastatic breast cancer, advanced ovarian cancer, progressive multiple myeloma in combination with bortezomib and AIDS-related Kaposi’ s sarcoma.
Il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Caelyx huma akbar mir- riskji tiegħu għat- trattament ta' kanċer metastatikutas- sider, il- kanċer ta 'l - 2/ 3 ovarji fi stadju avvanzat, il- mjeloma multipla progressiva u f' kombinazzjoni ma' bortezomib u s - sarkoma ta 'Kaposi relatata ma' l- AIDS.
The Committee recommended that Caelyx be given marketing authorisation.
Il- Kumitat irrakkomanda li Caelyx jingħata awtorizzazzjoni għat- tqegħid fis- suq.
2/ 3 Other information about Caelyx:
Tagħrif ieħor dwar Caelyx:
The European Commission granted a marketing authorisation valid throughout the European Union for Caelyx on 21 June 1996.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq għal Caelyx, valida fl- Unjoni Ewropea kollha fil- 21 ta 'Ġunju 1996.
The marketing authorisation holder is SP Europe.
Id- detentur ta 'l- awtorizzazzjoni għat- tqegħid fis- suq huwa SP Europe.
The marketing authorisation was renewed on 21 June 2001 and on 21 June 2006.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fil- 21 ta 'Ġunju 2001 u fil- 21 ta' Ġunju 2006.
The full EPAR for Caelyx can be found here.
L- EPAR sħiħ għal Caelyx huwa disponibbli minn hawn.
This summary was last updated in 02-2008.
Dan is- sommarju ġie aġġornat l- aħħar fi:
Caelyx 2 mg/ ml concentrate for solution for infusion
Caelyx 2 mg/ ml konċentrat għal soluzzjoni għall- infużjoni
One ml of Caelyx contains 2 mg doxorubicin hydrochloride in a pegylated liposomal formulation.
ml wieħed ta ’ Caelyx fih 2 mg doxorubicin hydrochloride b' formulazzjoni ta 'liposoma pegilata.
Caelyx, a liposome formulation, is doxorubicin hydrochloride encapsulated in liposomes with surface- bound methoxypolyethylene glycol (MPEG).
Caelyx, formulazzjoni ta ’ liposoma, huwa doxorubicin hydrochloride enkapsulat f' liposomi li għandhom methoxypolyethylene glycol marbut fil- wiċċ tagħhom (MPEG).
This process is known as pegylation and protects liposomes from detection by the mononuclear phagocyte system (MPS), which increases blood circulation time.
Dan il- proċess huwa magħruf bħala pegilazzjoni u jħares il- liposomi milli jinqabdu mis- sistema ta 'fagoċiti mononukleari (MPS) u dan iżid fil- ħin ta' ċirkolazzjoni fid- demm.
Concentrate for solution for infusion
Konċentrat għal soluzzjoni għall- infużjoni.
The suspension is sterile, translucent and red.
Is- suspensjoni hija sterili, jgħaddi d- dawl minnha u ta ’ kulur aħmar.
Caelyx is indicated:
Caelyx huwa indikat għal:
- As monotherapy for patients with metastatic breast cancer, where there is an increased cardiac
- Monoterapija għal pazjenti b' kanċer tas- sider metastatiku meta jkun hemm riskju kardijaku
risk.
akbar.
- For treatment of advanced ovarian cancer in women who have failed a first-line platinum-based
- Trattament għall- kanċer avvanzat ta ’ l- ovarji f' nisa li jkunu fallew l- kura preferita, reġim ta '
chemotherapy regimen.
kemoterapija bbażat fuq il- platinum.
- In combination with bortezomib for the treatment of progressive multiple myeloma in patients
- Flimkien ma ’ bortezomib għall- kura ta ’ majeloma multipla progressiva f’ pazjenti li rcievew
who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant.
mill- anqas terapija waħda qabel u li diġà kellhom trapjant jew ma jistax ikollhom trapjant tal - mudullun.
- For treatment of AIDS-related Kaposi’ s sarcoma (KS) in patients with low CD4 counts
- Trattament ta 'sarcoma ta' Kaposi (KS) relatata ma 'l- AIDS f' pazjenti b' għadd ta ’ CD4 baxx
(< 200 CD4 lymphocytes/ mm3) and extensive mucocutaneous or visceral disease.
(< 200 CD4 limfoċiti/ mm3) u b' mard mukokutanju jew vixxerali estensiv.
Caelyx may be used as first-line systemic chemotherapy, or as second line chemotherapy in AIDS-KS patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline).
Caelyx jista 'jintuża bħala kemoterapija tal- kura preferita, jew bħala kemoterapija tal- kura tat - tieni preferenza f' pazjenti AIDS- KS b' mard li baqa' jinfirex minkejja kimoterapija sistemika kkombinata li fiha mill- inqas tnejn mis- sustanzi li ġejjin: alkaloid vinka, bleomycin, u doxorubicin standard (jew anthracycline ieħor) jew li huma intolleranti għaliha.
Caelyx should only be administered under the supervision of a qualified oncologist specialised in the administration of cytotoxic agents.
Caelyx għandu jingħata biss taħt superviżjoni minn onkologu kwalifikat speċjaliżżat fl- għoti ta 'sustanzi ċitotossiċi.
Caelyx exhibits unique pharmacokinetic properties and must not be used interchangeably with other formulations of doxorubicin hydrochloride.
Caelyx għandu karatteristiċi farmakokinetiċi uniċi u m' għandux jingħata bħala sostitut ta 'formulazzjonijiet oħra ta' doxorubicin hydrochloride.
Breast cancer/ Ovarian cancer:
Kanċer tas- sider/ Kanċer ovarju:
Caelyx is administered intravenously at a dose of 50 mg/ m2 once every 4 weeks for as long as the disease does not progress and the patient continues to tolerate treatment.
Caelyx jingħata fil- vina b' doża ta '50 mg/ m2 darba kull 4 ġimgħat sakemm il- marda ma tibqax tipprogressa u sakemm il- pazjent jibqa' jittollera t- trattament.
Multiple Myeloma:
Majeloma Multipla:
Caelyx is administered at 30 mg/ m² on day 4 of the bortezomib 3 week regimen as a 1 hour infusion administered immediately after the bortezomib infusion.
Caelyx jingħata b’ 30 mg/ m2 f’ jum 4 tar- reġimen ta ’ 3 ġimgħat b’ bortezomib bħala infużjoni ta ’ siegħa 1 mogħtija eżattament wara l- infużjoni ta ’ bortezomib.
The bortezomib regimen
Ir- reġimen ta ’
2 consists of 1.3 mg/ m² on days 1, 4, 8, and 11 every 3 weeks.
2 bortezomib jikkonsisti f’ 1. 3 mg/ m2 f’ jiem 1, 4, 8, u 11 kull 3 ġimgħat.
The dose should be repeated as long as patients respond satisfactorily and tolerate treatment.
Id- doża għandha tiġi ripetuta sakemm il- pazjent ikollu rispons b’ mod sodisfaċenti u jkun jiflaħ għall- kura.
Day 4 dosing of both medicinal products may be delayed up to 48 hours as medically necessary.
Jum 4 tad- dożaġġi taż - żewġ prodotti mediċinali jista ’ jkun ittardjat sa 48 siegħa hekk kif ikun meħtieġ mill- lat mediku.
Doses of bortezomib should be at least 72 hours apart.
Id - doża ta ’ bortezomib għandha tkun mill- anqas 72 siegħa ‘ l bogħod.
For doses < 90 mg: dilute Caelyx in 250 ml 5% (50 mg/ ml) glucose solution for infusion.
Għal dożi < 90 mg: ħallat Caelyx ma '250 ml 5% (50 mg/ ml) soluzzjoni tal- glucose għall- infużjoni.
For doses ≥ 90 mg: dilute Caelyx in 500 ml 5% (50 mg/ ml) glucose solution for infusion.
Għal dożi ≥ 90 mg: ħallat Caelyx ma '500 ml 5% (50 mg/ ml) soluzzjoni tal- glucose għall- infużjoni.
To minimize the risk of infusion reactions, the initial dose is administered at a rate no greater than 1 mg/ minute.
Biex jonqsu r- riskji ta 'reazzjonijiet mill- infużjoni, l- ewwel doża tingħata b' rata mhux akbar minn 1 mg/ minuta.
If no infusion reaction is observed, subsequent Caelyx infusions may be administered over a 60-minute period.
Jekk ma jkunx jidher li hemm reazzjoni għall- infuzjoni, l- infużjonijiet b’ Caelyx li jingħataw wara din jistgħu jingħataw fuq medda ta '60 minuta.
In those patients who experience an infusion reaction, the method of infusion should be modified as follows:
F' dawk il- pazjenti li jkollhom reazzjoni għall- infużjoni, il- metodu ta 'infużjoni għandu jinbidel kif ġej:
5% of the total dose should be infused slowly over the first 15 minutes.
5% tad- doża kollha għandha tiġi infuża bil- mod fl- ewwel 15- il minuta.
If tolerated without reaction, the infusion rate may then be doubled for the next 15 minutes.
Jekk din tkun tollerata mingħajr reazzjoni, ir- rata ta 'infużjoni tista' tiġi rduppjata għall- 15- il minuta ta 'wara.
If tolerated, the infusion may then be completed over the next hour for a total infusion time of 90 minutes.
Jekk dan ikun tollerat, l- infużjoni tista 'titlesta fis- siegħa li jkun imiss b' żmien totali ta' l- infużjoni ta '90 minuta.
Caelyx is administered intravenously at 20 mg/ m2 every two-to-three weeks.
SK relatata ma 'l- AIDS Caelyx jingħata fil- vina b' doża ta' 20 mg/ m2 kull żewġ jew tlett ġimgħat.
Avoid intervals shorter than 10 days as medicinal product accumulation and increased toxicity cannot be ruled out.
Evita intervalli iqsar minn 10 ijiem peress li wieħed ma jistax jeskludi li jseħħ kumulu tal- prodott mediċinali u żjieda fit- tossiċità.
Treatment of patients for two-to-three months is recommended to achieve a therapeutic response.
It- trattament tal- pazjenti għal xahrejn jew tlett xhur huwa rrakkomandat biex jinkiseb rispons terapewtiku.
Continue treatment as needed to maintain a therapeutic response.
Kompli bit- trattament kif ikun jeħtieġ biex jinżamm ir- rispons terapewtiku.
The dose of Caelyx is diluted in 250 ml 5% (50 mg/ ml) glucose solution for infusion and administered by intravenous infusion over 30 minutes.
Id- doża ta’ Caelyx titħallat f' 250 ml 5% (50 mg/ ml) soluzzjoni tal- glucose għall- infużjoni u tingħata bħala infużjoni fil- vina fuq medda ta '30 minuta.
If the patient experiences early symptoms or signs of infusion reaction (see sections 4.4 and 4.8), immediately discontinue the infusion, give appropriate premedications (antihistamine and/ or short acting corticosteroid) and restart at a slower rate.
Għall- pazjenti kollha Jekk il- pazjent ikollu sintomi jew sinjali ta 'reazzjoni għall- infużjoni bikrin (ara sezzjonijiet 4. 4 u 4. 8), waqqaf l- infużjoni immedjatament, agħti premedikamenti xierqa (anti- istaminiċi u/ jew kortikosterojdi li jaħdmu malajr) u erġa' ibda t- trattament b' rata mnaqqsa.
Do not administer Caelyx as a bolus injection or undiluted solution.
Tagħtix Caelyx bħala injezzjoni bolus jew bħala soluzzjoni mhix dilwita.
It is recommended that the Caelyx infusion line be connected through the side port of an intravenous infusion of 5% (50 mg/ ml) glucose to achieve further dilution and minimise the risk of thrombosis and extravasation.
Huwa rakkomandat li l- linja ta 'l- infużjoni ta’ Caelyx titqabbad mill- port tal- ġenb ta' infużjoni fil- vina ta '5% (50 mg/ ml) glucose biex tiġi dilwita aktar u biex jitnaqqas ir- riskju ta' trombożi u ta 'fsada f’ xi tessut.
The infusion may be given through a peripheral vein.
L- infużjoni tista 'tingħata minn vina periferali.
Do not use with in-line filters.
Tużahax flimkien ma 'filtri tal- pajp tad- dripp.
Caelyx must not be given by the intramuscular or subcutaneous route (see section 6.6).
Caelyx m' għandux jingħata b' rotta intramuskolari jew fit- tessuti ta ’ taħt il- ġilda (ara sezzjoni 6. 6).
To manage adverse events such as palmar-plantar erythrodysesthesia (PPE), stomatitis or haematological toxicity, the dose may be reduced or delayed.
Biex timmaniġġja avvenimenti mhux mixtieqa bħal ma hi l- palmar- plantar erythrodysesthesia (PPE), stomatite jew tossiċità ematoloġika, id- doża tista 'titnaqqas jew tiġi ttardjata.
Guidelines for Caelyx dose modification secondary to these adverse effects are provided in the tables below.
Linji gwida għat- tibdil tad- dożaġġ ta’ Caelyx minħabba dawn l- effetti mhux mixtieqa jinstabu fit- tabelli hawn taħt.
The toxicity grading in these tables is based on the National Cancer Institute Common Toxicity Criteria (NCI-CTC).
Il - gradazzjoni ta 'tossiċità f' dawn it- tabelli hija bbażata fuq il- Kriterja tat- Tossiċità ta ’ l- Istitut Nazzjonali tal- Kanċer (NCI- CTC).
The tables for PPE (Table 1) and stomatitis (Table 2) provide the schedule followed for dose modification in clinical trials in the treatment of breast or ovarian cancer (modification of the recommended 4 week treatment cycle): if these toxicities occur in patients with AIDS related KS, the recommended 2 to 3 week treatment cycle can be modified in a similar manner.
It- tabelli għall- PPE (Tabella 1) u għall- istomatite (Tabella 2) jagħtu l- iskeda segwita għal tibdil fid - doża f' provi kliniċi fit- trattament ta 'pazjenti b' kanċer tas- sider jew ta ’ l- ovarji (tibdil taċ- ċiklu ta' trattament ta '4 ġimgħat): jekk dawn it- tossiċitajiet iseħħu f' pazjenti bil- KS relatata ma' l- AIDS, iċ - ċiklu ta ’ 2 jew 3 ġimgħat rakkomandat jista 'jinbidel b' mod simili.
The table for haematological toxicity (Table 3) provides the schedule followed for dose modification in clinical trials in the treatment of patients with breast or ovarian cancer only.
It- tabella għal tossiċità ematoloġika (Tabella 3) tagħti l- iskeda segwita għal tibdil fid- doża f' provi kliniċi fit- trattament ta 'pazjenti b' kanċer tas- sider jew ta ’ l- ovarji biss.
Dose modification in patients with AIDS-KS is addressed in 4.8.
It- tibdil tad- dożaġġ għal pazjenti b' AIDS- KS jitfisser f' 4. 8.
3 Guidelines For Caelyx Dose Modification
3 Linji gwida Għal Tibdil Tad- Dożaġġ Ta ’ Caelyx
PALMAR – PLANTAR ERYTHRODYSESTHESIA Week After Prior Caelyx Dose
PALMAR – PLANTAR ERYTHRODYSESTHESIA Gimgħa Wara D- Doża Caelyx Ta 'Qabel
Toxicity Grade At
Grad Ta 'Tossiċità Bl- Istimi Kurrenti
Week 4
Gimgħa 4
Week 5
Gimgħa 5
Week 6
Gimgħa 6
Redose unless Redose unless
Erġa agħti d- doża Erġa agħti d- doża
Decrease dose by
Naqqas id- doża
(mild erythema,
(ħmura tal- ġilda
patient has patient has
sakemm sakemm
25%; return to
b' 25%; erġa 'lura
swelling, or
ħafifa, nefħa, jew
experienced a experienced a
il- pazjent ma jkunx il- pazjent ma jkunx
4 week interval
għal intervalli ta '
desquamation not
deskwamazzjoni li ma ġarrab tfixkilx l- attivitajiet ta 'kuljum)
previous Grade 3 or
qabel tossiċità ġarrab tal- ġilda ta 'grad 3 jew 4, f' liema każ stenna ġimgħa oħra.
4 skin toxicity, in
qabel tossiċità tal- ġilda ta 'grad 3 jew 4, f' liema każ stenna ġimgħa oħra.
4 skin toxicity, in
4 ġimgħat.
Wait an additional Wait an additional
Stenna Ġimgħa Stenna Ġimgħa
(erythema,
(ħmura tal- ġilda,
week week
Oħra Oħra
desquamation, or
deskwamazzjoni, jew nefha li tfixkel, iżda li ma żżommx mill - attivitajiet normali; nfafet żgħar, ulċerazzjonijiet ta 'anqas minn 2 cm fid - dijametru)
4 week interval
għal intervalli ta '4 ġimgħat.
Withdraw patient
Aqta 'l- pazjent mit -
(blistering, ulceration, or swelling interfering with walking or normal daily activities; cannot wear regular clothing)
(infafet, ulċerazzjoni, jew nefha li tfixkel il - mixi jew l- attivitajiet normali ta 'kuljum; ma tistax tilbes il- ħwejjeġ tas- soltu)
week
Oħra Oħra
week
trattament
(diffuse or local process causing infectious
(proċess lokalizzat jew mifrux li jikkawża kumplikazzjonijiet infettivi jew li jwassal il- pazjent fis- sodda jew fi sptar)
STOMATITIS Week after Prior Caelyx Dose Toxicity Grade At Current Assessment
STOMATITE Ġimgħa Wara D- Doża Caelyx Ta 'Qabel Grad Ta' Tossiċità Bl- Istima Kurrenti
(painless ulcers,
(ulċeri li ma
erythema, or mild
jweġġgħux, ħmura tal -
experienced a experienced a
ġarrab qabel ġarrab qabel
4 week interval or
4 ġimgħat jew aqta '
soreness)
stomatite ta 'Grad 3
previous Grade 3 or previous Grade 3 or 4 stomatitis in which 4 stomatitis in which case wait an case wait an additional week additional week
stomatite ta ’ Grad 3
withdraw patient per physician’ s assessment
stenna ġimgħa oħra stenna ġimgħa oħra
(painful erythema,
(ħmura tal- ġilda bl - uġigħ, edima, jew ulċeri, iżda tista 'tiekol)
25%; return to
Oħra Oħra
4 week interval or withdraw patient per physician’ s assessment
b' 25%; erġa 'lura għal intervalli ta' 4 ġimgħat jew aqta 'l- pazjent mit - trattament skond l - istima tat- tabib
Grade 3 (painful erythema, edema, or ulcers, but cannot eat)
Grad 3
Wait an additional Wait an additional week week
Stenna Ġimgħa Stenna Ġimgħa
Grade 4 (requires parenteral or enteral support)
Grad 4
HAEMATOLOGICAL TOXICITY (ANC OR PLATELETS) – MANAGEMENT OF PATIENTS WITH BREAST OR OVARIAN CANCER
TOSSIĊITÁ EMATOLOĠIKA (ANC JEW PLEJTLETS) – IMMANIĠĠJAR TA 'PAZJENTI B' KANĊER TAS- SIDER JEW TA ’ L- OVARJI
PLATELETS
PLEJTLETS
MODIFICATION
TIBDIL
Resume treatment with no dose reduction.
1, 500 – 1, 900 75, 000 – 150, 000
Wait until ANC ≥ 1,500 and platelets ≥ 75,000; redose with no dose reduction.
Erġa 'ibda t- trattament mingħajr tnaqqis tad- doża.
500 – < 1,000
Stenna sakemm ANC ≥ 1, 500 u
25,000 – < 50,000
1, 000 – < 1, 500 50, 000 – < 75, 000 Grad 2 plejtlets ≥ 75, 000; erġa 'ddoża mingħajr tnaqqis tad- doża.
Wait until ANC ≥ 1,500 and platelets ≥ 75,000; redose with no dose reduction.
Stenna sakemm ANC ≥ 1, 500 u 500 – < 1, 000 25, 000 – < 50, 000 Grad 3 plejtlets ≥ 75, 000; erġa 'ddoża mingħajr tnaqqis tad- doża Stenna sakemm ANC ≥ 1, 500 u
< 25,000
< 25, 000
Wait until ANC ≥ 1,500 and platelets ≥ 75,000; decrease dose by 25% or continue full dose with growth factor support.
plejtlets ≥ 75, 000; naqqas id- doża b' 25% jew kompli bid- doża sħiħa u appoġġ tal- fattur tat- tkabbir.
For multiple myeloma patients treated with Caelyx in combination with bortezomib who experience PPE or stomatitis, the Caelyx dose should be modified as described in Table 1 and 2 above respectively.
Għall- pazjenti b’ majeloma multipla ikkurati b’ Caelyx flimkien ma ’ bortezomib li jkollhom PPE jew stomatite, id- doża ta ’ Caelyx għandha tikun mibdula hekk kif spjegat f’ Tabelli 1 u 2 hawn fuq rispettivament.
Table 4, below provides the schedule followed for other dose modifications in the clinical trial in the treatment of patients with multiple myeloma receiving Caelyx and bortezomib combination therapy.
Tabella 4 hawn taħt tipprovdi l- iskeda li tiġi segwita għal bidliet fid- dożi oħrajn fil - prova klinika fil- kura ta ’ pazjenti b’ majeloma multipla li jkunu qed jirċievu terapija b’ taħlita ta ’ Caelyx u bortezomib.
For more detailed information on bortezomib dosing and dosage adjustments, see the SPC for bortezomib.
Għal informazzjoni aktar dettaljata dwar id- dożi ta ’ bortezomib u aġġustamenti tad- dożaġġi, ara l- SPC ta ’ bortezomib.
DOSAGE ADJUSTMENTS FOR CAELYX + BORTEZOMIB COMBINATION THERAPY - PATIENTS WITH MULTIPLE MYELOMA
AĠĠUSTAMENTI TAD DOŻAĠĠI GĦAL TERAPIJA KOMIBNATA B’ CAELYX + BORTEZOMIB – PAZJENTI B’ MAJELOMA MULTIPLA
Patient Status
Stat tal- pazjent ○
Fever ≥ 38○ C and ANC < 1,000/ mm3
Deni ≥ 38 C u ANC < 1, 000/ mm3
Do not dose this cycle if before Day 4; if after Day 4, reduce next dose by 25%.
Tiddożax dan iċ- ċiklu jekk qabel ir- 4 Jum; jekk wara ir - 4 Jum, naqqas id- doża li jmiss b’ 25%.
Reduce next dose by 25%.
Naqqas id- doża li jmiss b’ 25%.
On any day of medicine administration after Day 1 of each cycle:
F’ kwalunkwe jum ta ’ l- għotja tal- mediċina wara Jum 1 ta ’ kull ċiklu:
Platelet count < 25,000/ mm3 Hemoglobin < 8 g/ dl ANC < 500/ mm3
Għadd tal- plejtlets < 25, 000/ mm3 Emoglobina < 8 g/ dl ANC < 500/ mm3
Do not dose this cycle if before Day 4; if after Day 4 reduce next dose by 25% in the following cycles if bortezomib is reduced for hematologic toxicity. *
Tiddożax dan iċ- ċiklu jekk qabel ir- 4 Jum; jekk wara ir - 4 Jum, naqqas id- doża li jmiss b’ 25% fiċ- ċikli li jmiss jekk bortezomib ikun imnaqqas minħabba tossiċità ematoloġika. *
Do not dose; if 2 or more doses are not given in a cycle, reduce dose by 25% in following cycles.
Tiddożax; jekk żewġ dożi jew aktar ma jingħatawx f’ ċiklu, naqqas id- doża b’ 25% fiċ - ċikli li jkun imiss.
Grade 3 or 4 non-hematologic medicine related toxicity
Grad 3 jew 4
Do not dose until recovered to Grade < 2 and reduce dose by 25% for all subsequent doses.
doża b’ 25% għad- dożi kollha doża b’ 25% għad- dożi kollha sussegwenti. sussegwenti.
Neuropathic pain or peripheral neuropathy
Uġigħ newropatiku jew newropatija periferali
No dosage adjustments.
L- ebda tibdil fid- dożaġġi.
See the SPC for bortezomib.
Ara l- SPC għal bortezomib.
*for more information on bortezomib dosing and dosage adjustment, see the SPC for bortezomib
* għal aktar informazzjoni dwar l- aġġustamenti fid- dożi u dożaġġi ta ’ bortezomib, ara l- SPC ta ’ bortezomib
Patients with impaired hepatic function:
Pazjenti b' funzjoni epatika dgħajfa:
Caelyx pharmacokinetics determined in a small number of patients with elevated total bilirubin levels do not differ from patients with normal total bilirubin; however, until further experience is gained, the Caelyx dosage in patients with impaired hepatic function should be reduced based on the experience from the breast and ovarian clinical trial programs as follows: at initiation of therapy, if the bilirubin is between 1.2 - 3.0 mg/ dl, the first dose is reduced by 25%.
Il- farmakokinetika ta ’ Caelyx ippruvata f' numru żgħir ta 'pazjenti b' livelli ta' bilirubin totali għolja ma kinitx differenti minn dik f' pazjenti b' bilirubin totali normali; madankollu sakemm ma tinkisibx aktar esperjenza, id- dożaġġ f' pazjenti li jbatu minn funzjoni epatika dgħajfa għandu jitnaqqas skond l- esperjenza miksuba mill- programmi ta 'provi kliniċi tas- sider jew ta ’ l- ovarji kif ġej: fil- bidu tat- terapija, jekk il- bilirubin ikun bejn 1. 2 - 3. 0 mg/ dl, l- ewwel doża titnaqqas b' 25%.
If the bilirubin is > 3.0 mg/ dl, the first dose is reduced by 50%.
Jekk il- bilirubin ikun > 3. 0 mg/ dl, l- ewwel doża titnaqqas b' 50%.