qanastek/EMEA-V3 huggingface dataset:
If you answer yes to any of the following questions talk to your doctor before you start to take Myfenax:
Jekk it- tweġiba hija iva għal xi waħda mill- mistoqsijiet li ġejjin kellem lit- tabib tiegħek qabel ma tibda ’ tieħu Myfenax:
44
51
Myfenax may cause spontaneous abortions or damage, including problems with development of the ears, to your unborn baby.
Dan għaliex Myfenax jista ’ jikkaġuna abort spontanju jew ħsara li jinkludu problemi fl- iżvilupp tal- widnejn tat- tarbija tiegħek li għadha ma twellditx.
No data are available to recommend the use of Myfenax in children and adolescents who have received a heart transplant.
L- ebda tagħrif ma hu disponibbli sabiex Myfenax jiġi rakkomandat fi tfal u adoloxxenti li rċevew trapjant tal- qalb.
The first dose of oral Myfenax will be given to you at least 4 days after the transplant operation and when you are able to swallow oral medicines.
52 L- ewwel doża ta ’ Myfenax li tittieħed mill- ħalq għandha tingħatalek ta ’ lanqas 4 ijiem wara l - operazzjoni ta ’ trapjant u meta tkun kapaci tibla ’ l- mediċini mill- ħalq.
The recommended daily dose is 6 tablets (3 g of the 45 active ingredient) taken as 2 separate doses.
Id- doża rakkomandata ta ’ kuljum hi ta ’ 6 pilloli (3 g tas- sustanza attiva) li tittieħed f’ żewġ dożi separati.
No data are available to recommend the use of Myfenax in children and adolescents who have received a liver transplant.
L- ebda tagħrif ma hu disponibbli sabiex Myfenax jiġi rakkomandat fi tfal li rċevew trapjant tal- fwied.
If you take more Myfenax than you should It is important not to take too many tablets.
Jekk tieħu aktar Myfenax milli suppost Huwa importanti li ma tieħux aktar pilloli milli suppost.
Stopping your treatment with Myfenax may increase the chance of rejection of your transplanted organ.
Jekk twaqqaf it- trattament tiegħek b’ Myfenax jista ’ jiżdied iċ- ċans għal riġezzjoni tal- organu trapjantat.
Common side effects likely to affect less than 1 in 10, but more than 1 in 100 people: • Changes in different laboratory parameters, including increase in liver enzymes, renal parameters such as creatinine, potassium, blood sugar, blood lipids, cholesterol, phosphates, magnesium, calcium and uric acid • Kidney problems with increased levels of urea • Disorders of the digestive system such as constipation, indigestion, flatulence, belching, inflammation of the mouth, oesophagus, stomach, intestine, liver or pancreas and gastrointestinal bleeding • Convulsions, increased tension in the muscles, shaking and muscle weakness, joint pain • Sleeplessness dizziness and headache, tingling or numbness, change of the sense of taste, loss of appetite, weight loss • Inflammation and infections of the respiratory and gastrointestinal tract, sore throat, inflammation of the sinuses, runny and itchy nose • Skin cancer or non cancerous growth of the skin and fungal infections of the skin and vagina • Changes in blood pressure, faster heart beat, dilation of blood vessels • Fluid retention in the body, fever, discomfort, lethargy and weakness
Effetti sekondarji komuni li x’ aktax jaffettwaw anqas minn persuna 1 f’ kull 10 imma aktar minn 1 f’ kull 100 persuna. • Bidliet fil- parametri tal- laboratorju, li jinkludi żieda fl- enżimi tal- fwied, parametric tal- kliewi bħal kreatinin u urea, potassjum, iz- zokkor fid- demm, lipidi fid- demm, kolesterol, phosphates, manjesju, kalċju u aċidu uriku • Disturbi tal- kliewi b’ żieda fil- livelli ta ’ l- urea • Disturbi fis- sistema diġestiva bħal stitikezza, indiġestjoni, gass fl- istonku, tifwieq, infjammazzjoni tal- ħalq, l- esofagu, l- istonku, l- imsaren, il- fwied jew il- frixa u emorraġija gastrointestinali. • Aċċessjonijiet, żieda fit- tensjoni tal- muskoli, rogħda u debolezza muskolari, uġigħ fil- ġogi • Nuqqas ta ’ rqad, stordamenti u uġigħ ta ’ ras, tnemin jew tirżiħ, bidla fis- sensazzjoni ta ’ togħma, nuqqas t’ aptit, nuqqas fil- piż
46 • Inflammation of the liver, yellowing of the skin and whites of the eyes
53 • Infjammazzjoni u infezzjonijiet fl- apparat respiratorju u gastrointestinali, uġigħ fil- griżmejn, infjammazzjoni tas- sinus, imnieħer iqattar jew bil- ħakk • Kanċer tal- ġilda jew żvilupp mhux kanċeroġeniku u infezzjonijiet fungali tal- ġilda u l- vaġina • Bidliet fil- pressjoni tad- demm, il- qalb tħabbat aktar malajr, jitwessgħu l- vażi tad- demm • Żamma ta ’ fluwidu fil- ġisem, deni, skonfort, letarġija u debbolezza • Infjammazzjoni tal- fwied, ġilda u l- abjad tal- għajnejn li jisfaru
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
Madankollu, m’ għandekx tieqaf tieħu l- mediċina qabel ma tkun iddiskutejtha mat- tabib tiegħek.
The active substance is 500 mg mycophenolate mofetil.
- Is- sustanza attiva hi 500 mg mycophenolate mofetil.
Hypromellose (HPMC 2910) Titanium dioxide (E171) Macrogol (PEG 400) Talc Indigo carmine aluminium lake (E132) Iron oxide black (E172) Iron oxide red (E172)
Hypromellose (HPMC 2910) Titanium dioxide (E171) Macrogol (PEG 400) Talc Indigo carmine aluminium lake (E132) Iron oxide black (E172)
What Myfenax looks like and contents of the pack
54 Iron oxide red (E172)
Film-coated tablets:
Id- dehra ta ’ Myfenax u d- daqs tal- pakkett Pilloli Myfenax miksija b’ rita:
Pale purple, oval shaped film-coated tablet, debossed with "M500" on one side and plain on the other side.
Pilloli miksija b’ rita ta ’ lewn il- lavanda pallida, f’ għamla ovali, intaljati “ M500 ” fuq naħa waħda u bla ebda disinn fuq in- naħa l- oħra.
47 Myfenax 500 mg film-coated tablets is available in PVC/ PVdC – aluminium blisters in pack sizes of 50 or 150 tablets per carton.
Il- pilloli miksija b’ rita ta ’ Myfenax 500 mg jiġu f’ pakketti tal- folji ta ’ PVC/ PVdC – aluminju li d - daqsijiet tagħhom huma ta ’ 50 jew 150 pillola f’ kull kartuna
Computerweg 10 3542 DR Utrecht The Netherlands
Computerweg 10, 3542 DR Utrecht l- Olanda
Teva Pharmaceuticals Works Private Limited Company H-2100 Gödöll ő, Táncsics Mihály ut 82 Hungary
Teva Pharmaceuticals Works Private Limited Company H- 2100 Gödöllő,, Táncsics Mihály t 82 L- Ungerija
What is Myocet?
X’ inhu Myocet?
Myocet is a powder and solutions to be made up into a solution for infusion (drip into a vein).
Myocet huwa trab u soluzzjonijiet li jitħalltu f’ soluzzjoni għal infużjoni (drip ġol- vina).
It contains the active substance doxorubicin hydrochloride.
Huwa fih is - sustanza attiva doxorubicin hydrochloride.
What is Myocet used for?
Għal x’ hiex jintuża Myocet?
Myocet is used with cyclophosphamide (an anticancer medicine) for the treatment of metastatic breast cancer in women. ‘ Metastatic ’ means the cancer that has spread to other parts of the body.
Myocet jintuża ma ’ cyclophosphamide (mediċina kontra l- kanċer) għall- kura ta ’ kanċer tas- sider metastatiku fin- nisa. ‘ Metastatiku ’ ifisser li l- kanċer infirex għall- partijiet oħra tal- ġisem.
How is Myocet used?
Kif jintuża Myocet?
Myocet should be used in units specialised in giving cytotoxic chemotherapy (cell-killing cancer treatments) under the supervision of a doctor who is qualified in the use of chemotherapy.
Myocet għandu jintuża f’ units speċjalizzati fl- għoti ta ’ kimoterapija ċitotossika (kuri li joqtlu ċ- ċelloli tal- kanċer) taħt superviżjoni ta ’ tabib ikkwalifikat fl- għoti ta ’ kimoterapija.
Myocet needs to be made up before use by mixing the separate components supplied in the pack and using a special heater or a water bath.
Myocet jeħtieġ li jitħallat qabel l- użu billi jitħalltu l- komponenti separati fornuti fil- pakkett u bl- użu ta ’ ħiter speċjali jew banju bl- ilma.
The recommended starting dose of Myocet is 60 to 75 mg per square metre body surface area (calculated using the patient’ s weight and height).
Id- doża tal- bidu ta ’ Myocet irrakkomandata hija 60 sa 75 mg kull metru kwadru ta ’ erja tal- wiċċ korporali (ikkalkulata permezz tal- piż u t- tul tal- pazjent).
It is given every three weeks by infusion into a vein over a period of one hour.
Jingħata kull tliet ġimgħat permezz ta ’ infużjoni ġol- vina fuq perijodu ta ’ siegħa.
The patient ’ s liver and bone marrow should be monitored during treatment using blood tests.
Il- fwied u l- mudullun tal- pazjenta għandhom jiġu sorveljati waqt il- kura permezz ta ’ testijiet tad- demm.
Treatment should be interrupted or the dose reduced if signs of liver problems or certain other side effects develop.
Il- kura għandha tiġi interotta jew id- doża għandha titnaqqas jekk jiżviluppaw sinjali ta ’ problemi tal- fwied jew ċerti effetti sekondarji.
How does Myocet work?
Kif jaħdem Myocet?
The active substance in Myocet, doxorubicin hydrochloride, is a cytotoxic (cell-killing) medicine that belongs to the group ‘ anthracyclines’.
Is- sustanza attiva f’ Myocet, doxorubicin hydrochloride, hija mediċina ċitotossika (toqtol iċ- ċelloli) li tappartieni għall- grupp ‘ anthracyclines ’.
It works by interfering with the DNA within cells, preventing them from making more copies of DNA and making proteins.
Hija taħdem billi tostakola d- DNA fi ħdan iċ- ċelloli, timpedixxihom milli jagħmlu aktar kopji ta ’ DNA u jagħmlu proteini.
Myocet accumulates in tumours, where its action can be concentrated.
Myocet jakkumula fit- tumuri, fejn l- azzjoni tiegħu tista ’ tkun konċentrata.
Doxorubicin hydrochloride has been available since the 1960s.
Doxorubicin hydrochloride ilu disponibbli sa mis- snin sittin.
In Myocet, doxorubicin hydrochloride is contained in microscopic fat particles called ‘ liposomes’.
F’ Myocet, doxorubicin hydrochloride jinsab f’ partikoli tax- xaħam mikroskopiċi msejħin ‘ lipożomi ’.
This reduces its negative effects on the heart and the gut, making it less likely to cause side effects.
Dan inaqqas l- effetti negattivi tiegħu fuq il- qalb u l- musrana, u għalhekk jagħmlu inqas probabbli li jikkawża effetti sekondarji.
Reproduction is authorised provided the source is acknowledged. combination with cyclophosphamide, in 297 women.
Fl- ewwel studju, Myocet tqabbel ma ’ doxorubicin (mhux lipożomali) standard, it- tnejn f’ kumbinazzjoni ma ’ cyclophosphamide, f’ 297 mara.
In the second study, Myocet alone was compared with standard doxorubicin alone in 224 women.
Fit- tieni studju, Myocet waħdu tqabbel ma ’ doxorubicin standard waħdu f’ 224 mara.
The third study compared the effects of Myocet with epirubicin (another anthracycline anticancer medicine), both in combination with cyclophosphamide in 160 women.
It- tielet studju qabbel l- effetti ta ’ Myocet ma ’ epirubicin (mediċina anthracycline kontra l- kanċer oħra), it- tnejn f’ kumbinazzjoni ma ’ cyclophosphamide f’ 160 mara.
In all three studies, the main measure of effectiveness was the proportion of patients who had responded to treatment after six weeks.
Fit- tliet studji kollha l- miżura ewlenija ta ’ l- effettività kienet il- proporzjon ta ’ pazjenti li rrispondew għall- kura wara sitt ġimgħat.
What benefit has Myocet shown during the studies?
X’ benefiċċju wera Myocet waqt l- istudji?
Myocet was as effective as the comparator medicines in all three studies.
Myocet kien effettiv daqs il- mediċini ta ’ tqabbil fit- tliet studji kollha.
In the first study, 43% of the patients receiving Myocet or standard doxorubicin in combination with cyclophosphamide responded to treatment, while in the study of Myocet or standard doxorubicin alone, 26% of each group responded.
Fl- ewwel studju, 43% tal- pazjenti li kienu qegħdin jirċievu Myocet jew doxorubicin standard f’ kumbinazzjoni ma ’ cyclophosphamide irrispondew għall- kura, waqt li fl- istudju ta ’ Myocet jew doxorubicin standard waħdu, irrispondew 26% ta ’ kull grupp.
In the third study, 46% of the patients taking Myocet in combination with cyclophosphamide responded to treatment, compared with 39% of those receiving epirubicin in combination with cyclophosphamide.
Fit- tielet studju, 46% tal- pazjenti li kienu qegħdin jieħdu Myocet f’ kombinazzjoni ma ’ cyclophosphamide irrispondew għall- kura, meta mqabbla ma ’ 39% ta ’ dawk li kienu qegħdin jirċievu epirubicin f’ kombinazzjoni ma ’ cyclophosphamide.
Patients receiving Myocet were less likely to experience heart problems than those receiving standard doxorubicin.
Pazjenti li kienu qegħdin jirċievu Myocet esperjenzaw inqas problemi tal- qalb minn dawk li kienu qegħdin jirċievu doxorubicin standard.
What is the risk associated with Myocet?
X’ inhu r- riskju assoċjat ma ’ Myocet?
The most common side effects with Myocet (seen in more than 1 patient in 10) are infection, neutropenic fever (fever associated with low white blood cell counts), neutropenia (low white blood cell counts), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), nausea (feeling sick) or vomiting, stomatitis (inflammation of the lining of the mouth) or mucositis (inflammation of the mouth and throat), diarrhoea, alopecia (hair loss), skin effects such as rash and dry skin, and fatigue, malaise (feeling unwell) or asthenia (weakness).
L- aktar effetti sekondarji komuni b’ Myocet (dehru f’ aktar minn pazjent 1 minn kull 10) huma infezzjoni, deni newtropiniku (deni assoċjat ma ’ għadd baxx taċ- ċelloli tad- demm), newtropenija (għedd baxx taċ- ċelloli tad- demm bojod), tromboċitopenija (għadd baxx ta ’ pjastrini tad- demm), anemija (għadd baxx taċ- ċelloli ħomor tad- demm), nawżja (dardir) jew remettar, stomatite (infjammazzjoni ta ’ l- inforra tal- ħalq) jew mukożite (infjammazzjoni tal- ħalq u tal- ġerżuma), dijarea, alopexija (telf ta ’ xagħar), effetti fil- ġilda bħal ma huma raxx jew ġilda xotta, u għeja kbira, tħossok ma tiflaħx jew astenja (djugħfija).
For the full list of all side effects reported with Myocet, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrapportati b’ Myocet, ara l- Fuljett ta ’ Tagħrif.
Myocet should not be used in people who may be hypersensitive (allergic) to doxorubicin or any of the other ingredients.
Myocet m’ għandux jintuża f’ nies li jistgħu jkunu sensittivi żżejjed (allerġiċi) għal doxorubicin jew għal kwalunkwe sustanza oħra tiegħu.
Why has Myocet been approved?
Għalfejn ġie approvat Myocet?
The Committee for Medicinal Products for Human Use (CHMP) noted that Myocet has a lower risk of heart problems than conventional doxorubicin, while both medicines have similar levels of effectiveness.
Il- Kumitat għal Prodotti Mediċinali għal Użu tal- Bniedem (CHMP) innota li Myocet għandu riskju aktar baxx ta ’ problemi tal- qalb milli doxorubicin konvenzjonali, waqt li ż- żewġ mediċini għandhom livelli simili ta ’ effettività.
Therefore, the Committee decided that Myocet’ s benefits are greater than its risks, in combination with cyclophosphamide, for the first-line treatment of metastatic breast cancer in women.
Għaldaqstant il- Kumitat iddeċieda li l- benefiċċji ta ’ Myocet f’ kombinazzjoni ma ’ cyclophoshamide, huma akbar mir- riskji tiegħu, għat- trattament ta ’ l- ewwel għażla ta ’ kanċer tas- sider metastatiku fin- nisa.
The Committee recommended that Myocet be given marketing authorisation.
Il- Kumitat irrakkomanda li Myocet jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Myocet:
Tagħrif ieħor dwar Myocet:
The European Commission granted a marketing authorisation valid throughout the European Union for Myocet on 13 July 2000.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq għal Myocet valida fl- Unjoni Ewropea kollha fit- 13 ta ’ Lulju 2000.
The marketing authorisation was renewed on 13 July 2005.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fit- 13 ta ’ Lulju 2005.
The marketing authorisation holder is Cephalon Europe.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq huwa Cephalon Europe.
The full EPAR for Myocet can be found here.
L- EPAR sħiħ għal Myocet jista ’ jinstab hawnhekk.
EU/ 1/ 00/ 141/ 001
Numru ta ’ l- EU EU/ 1/ 00/ 141/ 001
Myocet
Isem inventat Myocet
50 mg
Qawwa 50 mg
Powder and pre-admixtures for concentrate for liposomal dispersion for infusion
Għamla farmaċewtika Trab u sustanzi ta ’ qabel ma jsir it- taħlit għal konċentrat għat - tixrid liposomali għall- infużjoni
Intravenous use
Mnejn jingħata Għal użu ġol- vini
Powder: vial (glass) Pre-admixtures:
Il- pakkett Trab: fjala (ħġieġ) Sustanzi ta ’ qabel ma jsir it- taħlit:
Vial (glass) + Vial (glass)
Fjala (ħġieġ) + Fjala (ħġieġ)
2 sets of 3 vials
Daqs tal- pakkett 2 settijiet ta ’ 3 fjali
Myocet 50 mg powder and pre-admixtures for concentrate for liposomal dispersion for infusion
Myocet 50 mg trab u taħlita ta ’ qabel għal konċentrat għat- tixrid liposomali għall- infużjoni
Liposome– encapsulated doxorubicin– citrate complex corresponding to 50 mg doxorubicin HCl.
Kumpless ta ’ doxorubicin- citrate enkapsulat f’ liposoma li jikkorispondi għal 50 mg doxorubicin HCl.
Powder and pre-admixtures for concentrate for liposomal dispersion for infusion
Trab u taħlita ta ’ qabel għal konċentrat għat- tixrid liposomali għall- infużjoni.
Myocet is supplied as a three-vial system:
Myocet huwa provdut bħala sistema bi 3 fjali:
Myocet doxorubicin HCl (a red lyophilised powder), Myocet liposomes (a white to off-white, opaque and homogeneous solution), Myocet buffer (a clear colourless solution).
Myocet doxorubicin HCl (trab aħmar lajofilizzat), Myocet liposomi (soluzzjoni bajda tagħti fl- offwajt, opaka u omoġena), Myocet baffer (soluzzjoni ċara ta ’ bla kulur).
Myocet, in combination with cyclophosphamide, is indicated for the first line treatment of metastatic breast cancer in women.
Myocet, flimkien ma ’ cyclophosphamide, huwa intiż bħala l- ewwel fazi fil- kura ta ’ kanċer tas- sider fl - istadju metastatiku fin- nisa.
The use of Myocet should be confined to units specialised in the administration of cytotoxic chemotherapy and should only be administered under the supervision of a physician experienced in the use of chemotherapy.
Myocet għandu jingħata biss f’ entitajiet li huma speċjalizzati fl- għoti ta ’ kemjoterapija ċitotossika, u għandu jingħata biss taħt superviżjoni ta ’ tabib b’ experjenza fl- użu ta ’ kemjoterapija.
Dosage When Myocet is administered in combination with cyclophosphamide (600 mg/ m2) the initial recommended dose of Myocet is 60-75 mg/ m2 every three weeks.
Dożaġġ Meta Myocet jiġi mogħti flimkien ma ’ cyclophosphamide (600 mg/ m2) d- doża inizjali rrakkomandata ta ’ Myocet hi ta ’ 60- 75 mg/ m2 darba kull tlett ġimgħat.
Administration Myocet must be reconstituted and further diluted prior to administration (see section 6.6).
Kif għandu jingħata Myocet għandu jiġi rikostitwit u dilwit aktar qabel l- għotja (ara sezzjoni 6. 6).
A final concentration of between 0.4 to 1.2 mg/ ml doxorubicin HCl, is required.
Konċentrazzjoni finali ta ’ bejn 0. 4 sa 1. 2 mg/ ml doxorubicin HCl, hija meħtieġa.
Myocet is administered by intravenous infusion over a period of 1 hour.
Myocet jiġi mogħti b’ infużjoni intravenuża fuq perijodu ta ’ siegħa.
Myocet must not be administered by the intramuscular or subcutaneous route or as a bolus injection.
Myocet m’ għandux jingħata ġol- muskolu jew subkutanju jew bħala injezzjoni bolus.
Paediatric patients The safety and efficacy of Myocet has not yet been established in paediatric patients (below 18 years of age).
Pazjenti tfal Is- sigurtà u effikaċja ta ’ Myocet għadha ma ġietx stabbilita f’ pazjenti tfal (taħt l- età ta ’ 18- il sena).
Elderly patients Safety and efficacy of Myocet have been assessed in 61 patients with metastatic breast cancer, age 65 and over.
Pazjenti anzjani Is- sigurtà u l- effikaċja ta ’ Myocet ġew studjati f’ 61 pazjent li kellhom 65 sena jew aktar, b’ kanċer fis - sider fl- istadju metastatiku.
Data from randomised controlled clinical trials show that the efficacy and cardiac safety of Myocet in this population was comparable to that observed in patients less than 65 years old.
Informazzjoni miġbura minn randomised controlled clinical trtials turi li l- effikaċja u s- sigurtà kardijaka ta ’ Myocet f’ din il- popolazzjoni kienu paragunabbli ma ’ dawk osservati f’ pazjenti li għandhom inqas minn 65 sena.
Use in patients with impaired hepatic function As metabolism and excretion of doxorubicin occurs primarily by the hepatobiliary route, evaluation of hepatobiliary function should be performed before and during therapy with Myocet.
Użu f’ pazjenti b’ indeboliment fil- funzjoni epatika Billi l- metaboliżmu u l- eskrezzjoni ta ’ doxorubicin iseħħu primarjament mir- rotta epatobiljari, għandu jkun hemm evalwazzjoni tal- funzjoni epatobiljari qabel u waqt it- terapija b’ Myocet.
2 Based on limited data in patients with liver metastases, it is recommended that the initial dose of Myocet is reduced in accordance with the following table
2 Mit- tagħrif ristrett li nġib minn pazjenti b’ metastasi tal- fwied, huwa rakkomandat li d- doża inizjali ta ’ Myocet għandha titnaqqas skond it- tabella li ġejja
Liver function tests
Testijiet ta ’ kif qed jaħdem il- fwied
Bilirubin < ULN and normal AST Bilirubin< ULN and raised AST Bilirubin> ULN but< 50 μmol/l Bilirubin > 50 μmol/l
Bilirubin > ULN imma < 50 μmol/ l Bilirubin > 50 μmol/ l
Standard dose of 60 - 75mg/ m2 Consider a 25% dose reduction 50% dose reduction 75% dose reduction
Tnaqqis b’ 50% tad- doża Tnaqqis b’ 75% tad- doża
If possible, Myocet should be avoided in patients with bilirubin > 50 μ mol/ l as the recommendation is based mainly on extrapolations.
Jekk ikun possibbli, Myocet m’ għandux jintuża f’ pazjenti li l- bilirubin tagħhom hu > 50 μmol/ l billi r - rakkomandazzjoni hija bbażżata biss fuq estrapolazzjonijiet.
For dose reductions due to other toxicity, see section 4.4.
Għal tnaqqis ta ’ dożi minħabba tossiċitajiet oħrajn, ara sezzjoni 4. 4.
Use in patients with impaired renal function Doxorubicin is metabolised largely by the liver and excreted in the bile.
Użu f’ pazjenti b’ indeboliment fil- funzjoni renali Doxorubicin huwa prinċipalment metabolizzat fil- fwied u eliminat fil- bila.
Therefore dose modification is not required for patients with renal function impairment.
Għalhekk, tibdil fid- doża m’ huwiex meħtieġ għal pazjenti b’ indeboliment fil- funzjoni renali.
Hypersensitivity to the active substance, to the pre-admixtures or to any of the excipients.
Sensittività eċċessiva għas- sustanza attiva, għat- taħlitiet ta ’ qabel jew għal xi sustanzi mhux attivi.
Myelosuppression Therapy with Myocet causes myelosuppression.
Majelosoppressjoni Terapija b’ Myocet tikkaġuna majelosoppressjoni.
Myocet should not be administered to individuals with absolute neutrophil counts (ANC) lower than 1,500 cells/μ l or platelets less than 100,000/μ l prior to the next cycle.
Myocet m’ għandux jingħata lil individwi li għandhom għadd assolut ta ’ newtrofili (ANC) ta ’ inqas minn 1, 500 ċelluli/ μl jew plejtlets li l- għadd tagħhom huwa inqas minn 100, 000/ μl qabel iċ- ċiklu li jmiss.
Careful haematological monitoring (including white blood cell and platelet count, and haemoglobin) should be performed during therapy with Myocet.
Għandu jkun hemm monitoraġġ ematoloġiku kawt (li jinkludi l- għadd ta ’ ċelloli bojod tad- demm u tal- plejtlets, u l- emaglobina) waqt terapija b’ Myocet.
Haematological as well as other toxicity may require dose reductions or delays.
Jista ’ ikun hemm bżonn tnaqqis fid- dożi jew dewmien minħabba raġunijiet ematoloġiċi jew tossiċitajiet oħrajn.
The following dosage modifications are recommended during therapy and should be performed in parallel for both Myocet and cyclophosphamide.
Il- modifikazzjonijiet fid- dożi segwenti huma rrakkomandati waqt it- terapija u għandhom jitwettqu b’ mod parallel kemm għal Myocet u għal cyclophosphamide.
Dosing subsequent to a dose reduction is left to the discretion of the physician in charge of the patient.
Id- dożaġġ wara kull tnaqqis fid- doża huwa fid- diskrezzjoni tat- tabib li qed jieħu ħsieb il- pazjent.
Haematological Toxicity Grade
Tossiċità Ematoloġika Tibdil L- Għadd l- Aktar Baxx ta ’ Grad L- Għadd Assolut l - Plejtlets Aktar Baxx ta ’ ANC (celluli / μl) (celluli / μl)
Nadir ANC (cells/μ l)
1500 – 1900 1000 – Inqas minn 1500
Nadir Platelet Count (cells/μ l)
75, 000 – 150, 000 50, 000 – inqas minn 75, 000
Modification
Xejn Xejn
75,000 – 150,000 50,000 – Less than 75,000 25,000 – Less than 50,000
25, 000 – inqas minn 50, 000
None None Wait until ANC 1500 or more and/ or platelets 100,000 or more then redose at 25% dose reduction
Stenna sakemm l- ANC ta ’ 1500 jew aktar u / jew plejtlets ta ’ 100, 000 jew aktar imbagħad iddoża mill - ġdid bi tnaqqis ta ’ 25% fid - doża.
Less than 500
Inqas minn 500
Less than 25,000
Inqas minn 25, 000
Wait until ANC 1500 and/ or platelets 100,000 or more then redose at 50% dose reduction
Stenna sakemm l- ANC 1500 ta ’ u / jew plejtlets ta ’ 100, 000 jew aktar imbagħad iddoża mill- ġdid bi tnaqqis ta ’ 50% fid- doża
If myelotoxicity delays treatment to greater than 35 days after the first dose of the previous cycle, then consideration should be given to stopping treatment.
Jekk il- majelotossiċità ttellef il- kura għal aktar minn 35 jum wara l- ewwel doża taċ- ċiklu preċedenti, għandu jiġi kkunsidrat it- twaqqif tal- kura.
3 Mucositis Grade
Mukosite Tibdil
Modification
Sintomi
Painless ulcers, erythema, or mild soreness.
Ulċeri mingħajr uġigħ żgħir.
Painful erythema, oedema or ulcers but can eat.
Eritema b’ uġigħ, edema jew ulċeri imma tista tiekol.
Wait one week and if the symptoms improve redose at 100% dose
Stenna ġimgħa u jekk is- sintomi jitjiebu ddoża mill- ġdid b’ 100% tad- doża
Painful erythema, oedema or ulcers and cannot eat
Eritema b’ uġigħ, edema jew ulċeri u ma tistax tiekol
Wait one week and if symptoms improve redose at 25% dose reduction
Stenna ġimgħa u kemm- il darba s- sintomi mmorru għal aħjar, iddoża mill- ġdid bi tnaqqis ta ’ 25% fid- doża
Requires parenteral or enteral support
Tinħtieġ appoġġ parenterali jew enterali
Wait one week and if symptoms improve redose at 50% dose reduction
Stenna ġimgħa u kemm- il darba s- sintomi jmorru għal aħjar, iddoża mill- ġdid bi tnaqqis ta ’ 50% fid- doża
For dose reduction of Myocet due to liver function impairment, see section 4.2.
Għal tnaqqis fid- doża ta ’ Myocet minħabba indeboliment fil- funzjoni tal- fwied, ara sezzjoni 4. 2.
Cardiac toxicity Doxorubicin and other anthracyclines can cause cardiotoxicity.
Tossiċità kardijaka Doxorubicin u anthracyclines oħrajn jistgħu jikkaġunaw tossiċità kardijaka.
The risk of toxicity rises with increasing cumulative doses of those medicinal products and is higher in individuals with a history of cardiomyopathy, or mediastinal irradiation or pre-existing cardiac disease.
Ir- riskju ta ’ tossiċità jiżdied ma ’ żjidiet akkumulattivi fid- dożi ta ’ dawk il- prodotti mediċinali. Huma ogħla f’ individwi bi storja ta ’ kardjomijopatija, jew irradjazzjoni medjastinali jew li diġà kellhom mard tal- qalb.
Analyses of cardiotoxicity in clinical trials have shown a statistically significant reduction in cardiac events in patients treated with Myocet compared to patients treated with conventional doxorubicin at the same dose in mg.
Analiżi ta ’ kardjotossiċità fi provi kliniċi wrew tnaqqis statistikament sinjifikanti f’ każi kardijaċi f’ pazjenti kkurati b’ Myocet meta mqabbla ma ’ pazjenti kkurati b’ doxorubicin konvenzjonali fl- istess doża f’ mg.
The full clinical relevance of these findings is currently unclear.
Ir- rilevanza sħiħa klinika ta ’ dawn ir- riżultati s’ issa għadha m’ hiex ċara.
In a phase III study in combination with cyclophosphamide (CPA) comparing Myocet (60 mg/ m2) + CPA (600 mg/ m2) versus doxorubicin (60 mg/ m2) + CPA (600 mg/ m2), 6% versus 21% of patients, respectively, developed a significant decrease in left ventricular ejection fraction (LVEF).
Fi studju ta ’ fażi III flimkien ma ’ cyclophosphamide (CPA) meta ġie mqabbel Myocet (60 mg/ m2) + CPA (600 mg/ m2) ma doxorubicin (60 mg/ m2) + CPA (600 mg/ m2), f’ 6% kontra 21% tal- pazjenti, rispettivament, kien hemm żvilupp ta ’ tnaqqis sinifikanti fil- left ventricular ejection fraction (LVEF).
In a phase III study comparing single-agent Myocet (75 mg/ m2) versus single-agent doxorubicin (75 mg/ m2), 12% versus 27% of patients, respectively developed a significant decrease in LVEF.
Fi studju ta ’ fażi III meta ġie mqabbel Myocet waħdu (75 mg/ m2) ma ’ doxorubicin waħdu (75 mg/ m2), 12% kontra 27% tal- pazjenti rispettivament żviluppaw tnaqqis sinifikanti fl- LVEF.
The corresponding figures for congestive heart failure (CHF), which was less accurately assessed, were 0% for Myocet + CPA versus 3% for doxorubicin + CPA, and 2% for Myocet versus 8% for doxorubicin.
Il- figuri korrispondenti għal insuffiċjenza tal- qalb konġestiva (CHF) li ma kienetx studjata b’ daqshekk preċiżjoni, kienu 0% għal Myocet + CPA kontra 3% għal doxorubicin + CPA, u 2% għal Myocet kontra 8% għal doxorubicin.
The median lifetime cumulative dose of Myocet in combination with CPA to a cardiac event was > 1260 mg/ m2, compared to 480 mg/ m2 for doxorubicin combination with CPA.
Id- doża medjana kumulattiva f’ ħajjet iż- żmien ma ’ Myocet b’ CPA għal xi każ kardijaku kien ta ’ > 1260 mg/ m2, meta mqabbel ma ’ 480 mg/ m2 għal doxorubicin flimkien ma ’ CPA.
There is no experience with Myocet in patients with a history of cardiovascular disease, e. g. myocardial infarction within 6 months prior to treatment.
M’ hemmx tagħrif dwar Myocet f’ pazjenti bi storja ta ’ mard kardjovaskulari, eż. infart mijokardijaku fi żmien 6 xhur qabel kura.
Thus, caution should be exercised in patients with impaired cardiac function.
Għalhekk, attenzjoni għandha tintwera f’ pazjenti li għandhom indeboliment tal- funzjoni kardijaka.
The cardiac function of the patients treated concomitantly with Myocet and trastuzumab must be appropriately monitored as described below.
Il- funzjoni kardijaka ta ’ pazjenti kkurati b’ Myocet u trastuzumab fl- istess waqt għandha tiġi sorveljata b’ mod xieraq kif deskritt hawn taħt.
The total dose of Myocet should also take into account any previous, or concomitant, therapy with other cardiotoxic compounds, including anthracyclines and anthraquinones.
Id- doża kollha ta ’ Myocet għandha tingħata fil- konsapevolezza ta ’ kull terapija li ttieħdet qabel jew flimkien ma ’ sustanzi kardjotossiċi oħra, inklużi anthracyclines u anthraquinones.
Before initiation of Myocet therapy a measurement of left ventricular ejection fraction (LVEF) is routinely recommended, either by Multiple Gated Arteriography (MUGA) or by echocardiography.
Qabel ma ’ tibda terapija b’ Myocet huwa rrakkomandat li kull tant żmien jittieħed il- kejl tal- left ventricular ejection fraction (LVEF), jew permezz ta ’ Multiple Grated Arteriography (MUGA) jew b’ ekokardjografija.
These methods should also be applied routinely during Myocet treatment.
Dawn il- metodi għandhom jiġu applikati wkoll waqt kura b’ Myocet.
The evaluation of left ventricular function is considered mandatory before each additional administration of Myocet once a patient exceeds a lifetime cumulative anthracycline dose of 550 mg/ m2 or whenever cardiomyopathy is suspected.
L - evalwazzjoni tal- funzjoni ventrikulari tax- xellug hija kkunsidrata mandatorja qabel kull għoti ta ’ Myocet la darba pazjent jaqbeż id- doża akkumulattiva u ta ’ dejjem ta ’ anthracycline ta ’ 550 mg/ m2 jew kull meta hemm suspett ta ’ kardjomijopatija.
If LVEF has decreased substantially from baseline e. g. by > 20 points to a final value > 50% or by > 10 points to a final value of < 50%, the benefit of continued therapy must be carefully evaluated against the risk of producing irreversible cardiac damage.
Jekk ikun hemm tnaqqis ta ’ LVEF sostanzjali mill - livell ta ’ referenza bażi eż. b ’ > 20 punt għal valur finali ta ’ > 50% jew b ’ > 10 punti għal valur finali ta ’ < 50%, il- benefiċċju li t- terapija titkompla għandha tiġi evalwata b’ attenzjoni kontra r- riskju ta ’ ħsara irriversibbli kardijaka.
However, the most definitive test for anthracycline myocardial injury, i. e., endomyocardial biopsy, should be considered.
Madankollu, għandha tiġi kkunsidrata bijopsija endomijokardjali bħala test definittiv għal ferita mijokardjali ta ’ anthracycline.
All patients receiving Myocet should also routinely undergo ECG monitoring.
4 Il- pazjenti kollha fuq Myocet għandhom ta ’ spiss ikollhom monitoraġġ b’ ECG.
Transient ECG changes such as T-wave flattening, S-T segment depression and benign arrhythmias are not considered mandatory indications for the cessation of Myocet therapy.
Bidliet għaddiena f ’ ECG bħal l- illivellar tal- mewġa- T, depressjoni fis- settur S- T u arritmiji beninni m’ humiex ikkunsidrati indikazzjonijiet mandatorji għat- twaqqif tat- terapija b’ Myocet.
However, reduction of the QRS complex is considered more indicative of cardiac toxicity.
Madankollu, tnaqqis tal- kumpless QRS huwa kkunsidrat iktar indikattiv ta ’ tossiċità kardijaka.
Congestive heart failure due to cardiomyopathy may occur suddenly, and may also be encountered after discontinuation of therapy.
Insuffiċjenza tal- qalb konġestiva minħabba kardjomijopatija għandha mnejn iseħħ f’ daqqa, u għandha mnejn tiġri wkoll wara waqfien ta ’ terapija.
4 Injection site reactions Myocet should be considered an irritant and precautions should be taken to avoid extravasation.
Reazzjoni fil- post ta ’ l- injezzjoni Myocet għandu jiġi kkunsidrat bħala irritant u għandhom jittieħdu l- prekawzjonijiet meħtieġa sabiex tiġi evitata extravasation.
If extravasation occurs, the infusion should be immediately terminated.
Jekk extravasation isseħħ, l- infużjoni għandha titwaqqaf minnufih.
Ice may be applied to the affected area for approximately 30 minutes.
Għandu mnejn jitqiegħed is- silġ fuq ż- żona affetwata għal madwar nofs siegħa.
Subsequently, the Myocet infusion should be restarted in a different vein than that in which the extravasation has occurred.
Sussegwentement, l- infużjoni b’ Myocet għandha tibda mill- ġdid f’ vina differenti minn dik li fiha seħħet extravasation.
Note that Myocet may be administered through a central or peripheral vein.
Myocet jista ’ jingħata permezz ta ’ vina ċentrali jew periferika.
In the clinical program, there were nine cases of accidental extravasation of Myocet, none of which were associated with severe skin damage, ulceration or necrosis.
Fil- programm kliniku, kien hemm disa ’ każijiet ta ’ extravasation aċċidentali b’ Myocet, li l- ebda wieħed minnhom ma kien assoċjat ma ’ ħsara serja fil - ġilda, ulċerazzjoni jew nekrosi.
Infusion associated reactions When infused rapidly acute reactions associated with liposomal infusions have been reported.
Reazzjonijiet assoċjati ma ’ l- infużjoni Meta jiġi mogħti malajr kien hemm rapporti ta ’ reazzjonijiet akuti assoċjati ma ’ infużjonijiet liposomali.
Reported symptoms have included flushing, dyspnoea, fever, facial swelling, headache, back pain, chills, tightness in the chest and throat, and/ or hypotension.
Sintomi li ġew irraportati kienu jinkludu ħmura tal- wiċċ, dispneja, deni, tinfih tal- wiċċ, uġigħ ta ’ ras, uġigħ fid- dahar, sirdat, is- sider u l- griżmejn jinħassu issikati u/ jew pressjoni baxxa.
These acute phenomena may be avoided by using a 1-hour infusion time.
Dawn l- effetti akuti jistgħu jiġu evitati jekk l- infużjoni ddum sejra għal xi siegħa.
Other For precautions regarding the use of Myocet with other medicinal products, see section 4.5.
Oħrajn Għal prekawzjonijiet rigward l- użu ta ’ Myocet ma ’ prodotti mediċinali oħrajn, ara sezzjoni 4. 5.
Efficacy and safety of Myocet in the adjuvant treatment of breast cancer have not been determined.
Effikaċja u sigurtà ta ’ Myocet fil- kura miżjuda f ’ kanċer tas- sider ma ġewx stabbiliti.
The importance of apparent differences in tissue distribution between Myocet and conventional doxorubicin has not been elucidated with respect to long-term antitumour efficacy.
L- importanza ta ’ differenzi li jidhru fid- distribuzzjoni tat- tessuti bejn Myocet u doxorubicin konvenzjonali għadha ma ġietx spjegata fir- rigward ta ’ effikaċja anti- tumurali għat- tul.
Specific drug compatibility studies have not been performed with Myocet.
Studji ta ’ kompatibilità ma ’ prodotti mediċinali speċifiċi ma ’ sarux b’ Myocet.
Myocet is likely to interact with substances that are known to interact with conventional doxorubicin.
X’ aktarx li jkun hemm effetti interattivi bejn Myocet u sustanzi oħrajn li huma magħrufa li joħolqu interazzjoni b ’ doxorubin konvenzjonali.
Plasma levels of doxorubicin and its metabolite, doxorubicinol, may be increased when doxorubicin is administered with cyclosporin, verapamil, paclitaxel or other agents that inhibit P-glycoprotein (P-Gp).
Livelli fil- plażma ta ’ doxorubicin u l- metabolit tiegħu, doxorubicinol, għandhom mnejn jogħlew meta doxorubicin jiġi mogħti ma’ cyclosporin, verapamil, paclitaxel u sustanzi oħrajn li jimpedixxu P- glycoprotein (P- Gp).
Interactions with doxorubicin have also been reported for streptozocin, phenobarbital, phenytoin and warfarin.
Ġew irrapportati wkoll interazzjonijiet ma ’ doxorubicin għal streptozocin, phenobarbital, phenytoin u warfarin.
Studies of the effect of Myocet on other substances are also lacking.
Studji fuq l- effett ta ’ Myocet fuq sustanzi oħrajn huma ukoll nieqsa.
However, doxorubicin may potentiate the toxicity of other antineoplastic agents.
Madankollu, doxorubicin għandu mnejn jkabbar it- tossiċità ta ’ aġenti anti - neoplastiċi oħrajn.
Concomitant treatment with other substances reported to be cardiotoxic or with cardiologically active substances (e. g. calcium antagonists) may increase the risk for cardiotoxicity.
Kura konkomitanti ma ’ sustanzi oħrajn rapportati li huma kardjotossiċi jew ma ’ sustanzi attivi kardjoloġikament (eż. antagonisti tal- kalċju) għandhom mnejn jżidu r- riskju ta ’ kardjotossiċità.
Concomitant therapy with other liposomal or lipid-complexed substances or intravenous fat emulsions could change the pharmacokinetic profile of Myocet.
Terapija konkomitanti ma ’ sustanzi liposomali oħrajn jew kumplessi b ’ lipidi jew emulsjonijiet żejtnija ġol- vina jistgħu jibdlu l- profil farmakokinetiku ta ’ Myocet.
Due to the known cytotoxic, mutagenic and embryotoxic properties of doxorubicin, Myocet should not be used during pregnancy unless clearly necessary.
Minħabba l- karatteristiċi ċitotossiċi, mutaġeniċi u embrijotossiċi magħrufa ta ’ doxorubicin, Myocet m’ għandux jintuża waqt it- tqala ħlief meta hemm bżonn speċifiku.
Women of childbearing potential should use an effective contraceptive during treatment with Myocet and up to 6 months following discontinuation of therapy.
Nisa li jistgħu joħorġu tqal għandhom jużaw kontraċettiv effettiv waqt il- kura b’ Myocet u sa 6 xhur wara l- waqfien tat- terapija.
Women receiving Myocet should not breastfeed.
Nisa li jkunu fuq Myocet m’ għandhomx ireddgħu.
4.7 Effect on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
Myocet has been reported to cause dizziness.
Myocet ġie rapportat li jikkaġuna sturdamenti.
Patients who suffer from this should avoid driving and operating machinery.
Pazjenti li jbatu minn dan għandhom jevitaw li jsuqu u jħaddmu magni.
Clinical Program
Programm Kliniku
Adverse drug reactions (ADR) data obtained from 323 patients with metastatic breast cancer in three randomised phase III trials of Myocet as a single agent and in combination with Cyclophosphamide (CPA) have been provided in Table 1 as pooled data.
Tagħrif miksub mir- reazzjonijiet avversi tad- droga (ADR) għal Myocet bħala l- mediċina ewlenija u wkoll flimkien ma ’ Cyclophosphamide (CPA) minn fuq 323 pazjent b’ kanser tas- sider fi stat metastatiku fi tlett provi randomized tat- III fażi qed jiġu mogħtija fl- 1el Tabella bħala tagħrif ipuljat.
Treatment cycles were every three weeks in each trial and G-CSF was used in 38-56% of the cycles.
Iċ- ċikli ta ’ kura kienu kull tlett ġimgħat u l- G- CSF kien użat f’ 38- 56% taċ- ċikli.
Adverse reactions from pooled study results of three randomised Phase III clinical trials of Myocet as a single agent and in combination with Cyclophosphamide (CPA).
Reazzjonijiet avversi minn riżultati ipuljati fi tlett provi kliniċi randomized ta ’ Fażi III ta ’ Myocet bħala l- mediċina ewlenija u b’ kombinazzjoni ma ’ Cyclophosphamide (CPA).
System Organ Class
Reazzjonijiet Avversi 1, 2
Frequency (as percentage)
Frekwenza (bħala perċentwal)
Adverse Reactions1,2
Infezzonijiet u Infestazzjonijiet
Infections and Infestations
Infezzjoni
Infection (All Grades) (Grade ≥ 3) Neutropenic Fever3
(Kull Grad) (Grad ≥3)
Blood and Lymphatic System
Disturbi tad- Demm u tas -
11 9
Newtropenija
ANC< 500 & fever > 38˚C 3,4 ANC> 500 & fever > 38˚ C 3,4 Neutropenia
Sistema Limfatika
< 2000/ µl < 500/ µl < 500/ µl for ≥ 7 days Thrombocytopenia
< 500/ µl għal ≥ 7 t’ ijiem Tromboċitopenija
(All Grades) (Grade ≥ 3) Diarrhoea
(Kull Grad) (Grad ≥3) Dijarrea
(All Grades) (Grade ≥ 3)
(Kull Grad) (Grad ≥3)
Skin and Subcutaneous Tissue
Disturbi fil- Ġilda u fit- Tessuti
Alopecia - Pronounced
Alopeċja – Tidher sew
Disorders
ta ’ taħt il- Ġilda
Skin Related Toxicities (e. g. rash, dry skin)
Disturbi Ġenerali u
(All Grades) (Grade ≥ 3)
(Kull Grad) (Grad ≥3) Għejja/ Telqa/ Astenija
General Disorders and
Kundizzjonijiet ta ’ Mnejn Jingħata
(All Grades) (Grade ≥ 3) Injection Site Toxicity
(Kull Grad) (Grad ≥3) Tossiċità fil- lok ta ’ l - injezzjoni
Incidence of the adverse reaction considered at least possibly related by the investigator, from pooled clinical trials involving 323 patients taking the medicinal product.
6 1 L- inċidenza tar- reazzjoni avversa hija kkonsidrata li tista ’ tkun possibbilment relatata mir- riċerkatur, minn provi kliniċi ppuljati li kienu jinvolvu 323 pazjent li ħadu l- prodott mediċinali.
2 all adverse reactions have been ranked by frequency within each system organ class.
2 Ir- reazzjonijiet avversi kollha ġew irrankjati skond il- frekwenza tas- sistema tal- klassifikazzjoni ta ’ l - organi.
3 with IV antibiotics and/ or hospitalisation 4 absolute neutrophil counts (ANC)
3 b’ antibijotiċi IV u/ jew żamma fl- isptar 4 għadd assolut ta ’ newtrofili (ANC)
The following clinically relevant grade 3/ 4 adverse reactions with an incidence of < 5% were also observed from clinical trials involving 948 patients with solid tumours.
Ir- reazzjonijiet klinikament rilevanti ta ’ grad 3/ 4 li ġejjin u li għandhom inċidenza ta ’ < 5% kienu osservati wkoll fi provi kliniċi li kienu jinvolvu 948 pazjent f’ tumuri solidi.
AIDS patients with Kaposi’ s sarcoma were not included.
Pazjenti bl- AIDS bis - Sarkoma ta ’ Kaposi ma kienux inklużi.
Incidence of less than 5% (Grade 3 or 4, possibly, probably, or definitely related):
Inċidenza ta ’ inqas minn 5% (Grad 3 jew 4, li jistgħu jkunu relatati b’ mod possibbli, b’ mod probabbli jew b’ mod definittiv):
6 Infections and Infestations: fever, Herpes Zoster, injection site infection, sepsis
Infezzjoni u Infestazzjoni: deni, Herpes Zoster, infezzjoni fil- lok ta ’ l- injezzjoni, sepsis
Blood and Lymphatic System Disorders: leukopenia, lymphopenia, neutropenic sepsis, purpura
Disturbi tad- Demm u tas- Sistema Limfatika: lewkopenija, limfopenija, sepsis newtropeniku, purpura
Metabolism and Nutrition Disorders: anorexia, dehydration, hypokalaemia, hyperglycaemia
Disturbi fil- Metaboliżmu u n- Nutrizzjoni: anoreksja, diżidrazzjoni, ipokalemija ipergliċeemija
Psychiatric Disorders: agitation
Disturbi Psikjatriċi: aġitazzjoni
Nervous System Disorders: abnormal gait, dysphonia, insomnia, somnolence
Disturbi fis- Sistema Nervuża: pass anormali, disfonja, nuqqas ta ’ rqad, ngħas
Cardiac Disorders: arrhythmia, cardiomyopathy, congestive cardiac failure, pericardial effusion
Disturbi fil- Qalb: arritmija, kardjomijopatija, insuffiċjenza tal- qalb konġestiva, tnixxija perikardjali
Vascular Disorders: hot flushes, hypotension
Disturbi Vaskulari: ħmurija sħuna, pressjoni baxxa ħafna
Respiratory, Thoracic and Mediastinal Disorders: chest pain, dyspnoea, epistaxis, haemoptysis, pharyngitis, pleural effusion, pneumonitis
Disturbi Respiratorji, Toraċiċi u Medjastinali: uġigħ fis- sider, dispnea, epistassi, emoptassi, farinġite tnixxija plewrali, pnewmonite
Gastrointestinal Disorders: constipation, gastric ulcer, oesophagitis
Disturbi Gastro- intestinali: stitikezza, ulċeri fl- istonku, esofaġite
Hepato-Biliary Disorders: increased hepatic transaminases, increased alkaline phosphatase, increased serum bilirubin, jaundice
Disturbi fil- Fwied u fil- Marrara: transaminases epatiċi ogħla, alkaline phosphatase ogħla, bilirubin fis- serum ogħla, suffejra
Musculoskeletal, Connective Tissue and Bone Disorders: back pain, muscle weakness, myalgia
Disturbi Muskolu- skeltrali, tal- Connective Tissue u tal- Għadam: uġigħ fid- dahar, dgħjufija fil - muskoli, majalġja
Skin and Subcutaneous Tissue Disorders: folliculitis, nail disorder, pruritus,
Disturbi fil- Ġilda u fit- Tessuti ta ’ taħt il- Ġilda: follikulite, mard tad- dwiefer, ħakk
Renal and Urinary Disorders: haemorrhagic cystitis, oliguria
Disturbi fil- Kliewi u fis- Sistema Urinarja: ċistite emorraġika, oligurja
General Disorders and Administration Site Conditions: dizziness, headache, injection site reaction, pain, rigors, weight loss
Disturbi Ġenerali u Kundizzjonijiet ta ’ Mnejn Jingħata: stordament, uġigħ ta ’ ras, reazzjoni fis- sit ta ’ l- injezzjoni, uġigħ, tertir, telf fil- piż
Post-Marketing
Wara t- tqegħid fis- Suq
Relevant adverse reactions obtained from post marketing surveillance have been tabulated in Table 2.
Ir- reazzjonijiet avversi rilevanti miksuba minn sorvelljanza magħmula wara t- tqegħid fis- suq ġew tabellati f’ Tabella 2.
Adverse reactions obtained from post-marketing surveillance (4.5 years data).
Reazzjonijiet avversi miksuba mis- sorvelljanza magħmula wara t- tqegħid fis- suq tal - prodott (tagħrif miġbur fuq 4. 5 snin)
System Organ Class
Sistema tal- Klassifika tal- Organi
Adverse Reactions
Reazzjonijiet Avversi
Blood and Lymphatic System Disorders
Disturbi tad- Demm u tas - Sistema Limfatika
Pancytopenia
Panċitopenija
Acute overdose with Myocet will worsen toxic side effects.
Doża eċċessiva akuta b’ Myocet ser tħarrax effetti tossiċi oħrajn.
Treatment of acute overdose should focus on supportive care for expected toxicity and may include hospitalisation, antibiotics, platelet and granulocyte transfusions and symptomatic treatment of mucositis.
Il- kura ta ’ doża eċċessiva akuta għandha tkun immirata fuq kura ta ’ appoġġ għat- tossiċità mistennija u għandha mnejn tinkludi żamma fi sptar, antibijotiċi, trasfużjonijiet ta ’ plejtlets u granuloċiti u kura sintomatika għal mukosite.
Cytotoxic agents (anthracyclines and related substances), ATC code:
Sustanzi ċitotossiċi (anthracyclines u sustanzi relatati), Kodiċi ATC:
7 The active substance in Myocet is doxorubicin HCl.
Is- sustanza attiva f ’ Myocet hija doxorubicin HCl.
Doxorubicin may exert its antitumour and toxic effects by a number of mechanisms including inhibition of topoisomerase II, intercalation with DNA and RNA polymerases, free radical formation and membrane binding.
Doxorubicin għandu mnejn jeżerċita l- effetti ta ’ kontra t- tumur u l- effetti tossiċi b’ numru ta ’ mekkaniżmi li jinkludu l- impediment ta ’ topoisomerase II, interkalazzjoni b ’ DNA u RNA polymerases, formazzjoni ta ’ radikali ħielsa u tirbit mar- riti.
Liposomal-encapsulated compared with conventional doxorubicin was not found more active in doxorubicin resistant cell lines in vitro.
Doxorubicin enkapsulat fil- liposomi meta mqabbel ma ’ doxorubicin konvenzjonali ma ntweriex li hu aktar attiv f’ razzez ta ’ ċelluli reżistenti ta ’ doxorubicin in vitro.
In animals, liposome-encapsulated doxorubicin reduced the distribution to heart and gastrointestinal mucosa compared with conventional doxorubicin, while antitumoural efficacy in experimental tumours was maintained.
F’ annimali, doxorubicin enkapsulat fil- liposomi naqqas il- firxa fil- mukosa tal- qalb u dik gastro- intestinali, meta mqabbel ma ’ doxorubicin konvenzjonali, waqt li l- effikaċja anti- tumorali f’ tumuri sperimentali baqgħet sostnuta.
Myocet (60 mg/ m2) + CPA (600 mg/ m2) was compared with conventional doxorubicin + CPA (at the same doses) and Myocet (75 mg/ m2) + CPA (600 mg/ m2) was compared to epirubicin + CPA (at the same doses).
Myocet (60 mg/ m2) + CPA (600 mg/ m2) kienu pparagunati ma ’ doxorubicin konvenzjonali + CPA (fl - istess dożi) u Myocet (75 mg/ m2) + CPA (600 mg/ m2) kienu pparagunati ma ’ epirubicin + CPA (fl - istess dożi).
In a third trial, Myocet (75 mg/ m2) monotherapy was compared with conventional doxorubicin monotherapy (at the same dose).
Fit- tielet prova, monoterapija b’ Myocet (75 mg/ m2) ġiet mqabbla ma ’ monoterapija konvenzjonali b’ doxorubicin (fl- istess doża).
Findings regarding response rate and progression-free survival are provided in Table 3.
Riżultati rigward rati ta ’ rispons u sopravivenza mingħajr progress huma provduti fit- Tabella 3.