qanastek/EMEA-V3 huggingface dataset:
If the patient tolerates the first dose without an increase in serum bilirubin or liver enzymes, the dose for cycle 2 can be increased to the next dose level, i. e., if reduced by 25% for the first dose, increase to full dose for cycle 2; if reduced by 50% for the first dose, increase to 75% of full dose for cycle 2.
6 tiżdied għall- livell ta 'dożaġġ li jmiss, jiġifieri, jekk imnaqqas b' 25% għall- ewwel doża, jiżdied għad - doża sħiħa għaċ- ċiklu 2, jekk imnaqqsa b' 50% għall- ewwel doża, jiżdied sa 75% tad- doża sħiħa għaċ- ċiklu 2.
The dosage can be increased to full dose for subsequent cycles if tolerated.
Id- dożaġġ jista 'jiżdied sad- dożaġġ sħiħ għaċ- ċikli ta' wara jekk ikun ittollerat.
Caelyx can be administered to patients with liver metastases with concurrent elevation of bilirubin and liver enzymes up to 4 x the upper limit of
Caelyx jista 'jingħata lil pazjenti b' metastasi fil- fwied u li għandhom żieda ta' bilirubin u enzimi tal- fwied 4 darbiet l- ogħla limitu tal- medda normali.
Prior to Caelyx administration, evaluate hepatic function using conventional clinical laboratory tests such as ALT/ AST, alkaline phosphatase, and bilirubin.
Qabel jingħata Caelyx, irid jitqies il- funzjoni tal- fwied billi jintużaw it- testijiet kliniċi konvenzjonali tal- laboratorju bħalma huma ALT/ AST, alkaline phosphotase u bilirubin.
Patients with impaired renal function:
Pazjenti b' funzjoni tal- kliewi dgħajfa:
As doxorubicin is metabolised by the liver and excreted in the bile, dose modification should not be required.
Peress illi doxorubicin jiġi metabolizzat fil- fwied u jitneħħa mill- ġisem mal- bajl, m' għandux ikun meħtieġ tibdil fid- doża.
Population pharmacokinetic data (in the range of creatinine clearance tested of 30 - 156 ml/ min) demonstrate that Caelyx clearance is not influenced by renal function.
Informazzjoni farmakokinetika tal - popolazzjoni (fil- medda ta 'creatinine clearance ittestjata ta' 30- 156 ml/ min) turi li l- clearance ta’ Caelyx mhix affettwata mit- tħaddim tal- kliewi.
No pharmacokinetic data are available in patients with creatinine clearance of less than 30 ml/ min.
M’ hemmx informazzjoni dwar pazjenti b' clearance tal- krejatinina ta 'anqas minn 30 ml/ min.
AIDS-KS patients with splenectomy:
Pazjenti AIDS- KS li tkun tneħħitilhom il- milsa:
As there is no experience with Caelyx in patients who have had splenectomy, treatment with Caelyx is not recommended.
Peress illi mhemmx esperjenza ta 'pazjenti li tkun tneħħitilhom il- milsa t- trattament b’ Caelyx mhux rakkomandat.
Paediatric patients:
Pazjenti pedjatriċi:
The experience in children is limited.
L- esperjenza fit- tfal hija limitata.
Caelyx is not recommended in patients below 18 years of age.
Caelyx mhux rakkomandat fi tfal taħt it- 18- il sena.
Population based analysis demonstrates that age across the range tested (21 – 75 years) does not significantly alter the pharmacokinetics of Caelyx.
Analiżi bbażata fuq popolazzjoni turi li fil- medda ttestjata (21 – 75 sena) l- età ma tibdilx il- farmakokinetiċi ta ’ Caelyx.
• Hypersensitivity to the active substance or to any of the excipients.
• sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi
Caelyx must not be used to treat AIDS-KS that may be treated effectively with local therapy or systemic alfa-interferon.
Caelyx m' għandux jintuża għat- trattament ta 'l- AIDS- KS li jista' jiġi ttrattat b’ mod effettiv b' terapija lokali jew sistematika ta ’ alfa- interferon.
Cardiac toxicity:
Tossiċità kardijaka:
It is recommended that all patients receiving Caelyx routinely undergo frequent ECG monitoring.
Huwa rakkomandat li l- pazjenti kollha li jkunu qed jieħdu Caelyx isirilhom monitoraġġ ECG frekwenti u ta 'rutina.
Transient ECG changes such as T-wave flattening, S-T segment depression and benign arrhythmias are not considered mandatory indications for the suspension of Caelyx therapy.
Tibdil ta 'l- ECG li ma jdumux bħal ċċattjar tat- T- wave, dipressjoni tas- segment S- T u arrittmiji beninji mhumiex meqjusa bħala sinjali li bilfors għandha titwaqqaf it- terapija b’ Caelyx.
However, reduction of the QRS complex is considered more indicative of cardiac toxicity.
Madankollu tnaqqis tal- QRS complex jitqies li hu iżjed indikattiv ta 'tossiċità kardijaka.
If this change occurs, the most definitive test for anthracycline myocardial injury, i. e., endomyocardial biopsy, must be considered.
Jekk isseħħ din il- bidla, għandu jiġi kkunsidrat it- test l- iżjed definittiv għad- dannu mijokardijaku anthracycline jiġifieri bijopsija endomijokardika.
More specific methods for the evaluation and monitoring of cardiac functions as compared to ECG are a measurement of left ventricular ejection fraction by echocardiography or preferably by Multigated Angiography (MUGA).
Metodi iżjed speċifiċi għall- evalwazzjoni u monitoraġġ tat- tħaddim tal- qalb meta mqabbla ma 'l- ECG huma l- kejl tal- frazzjoni tal- ħruġ ventrikolari tax- xellug permezz ta' ekokardjografija jew preferibbilment permezz ta 'Anġografija Multigated (MUGA).
These methods must be applied routinely before the initiation of Caelyx therapy and repeated periodically during treatment.
Dawn il- metodi għandhom jintużaw b’ rutina qabel ma tinbeda t- terapija b’ Caelyx u jerġgħu isiru perijodikament waqt it- trattament.
The evaluation of left ventricular function is considered to be mandatory before each additional administration of Caelyx that exceeds a lifetime cumulative anthracycline dose of 450 mg/ m2.
L - evalwazzjoni tat- tħaddim ventrikolari tax- xellug titqies bħala mandatorja qabel ma jingħata aktar Caelyx li jaqbeż id- doża kumulattiva tul il- ħajja ta 'anthracycline ta' 450 mg/ m2.
ECG monitoring, measurement of left ventricular ejection fraction, endomyocardial biopsy.
It- testijiet u l- metodi ta 'evalwazzjoni imsemmija hawn fuq rigward il- monotoraġġ tat- tħaddim tal- qalb waqt it- terapija b' anthracycline għandhom isiru fl- ordni li ġej: monitoraġġ ECG, kejl tal- frazzjoni tal - ħruġ ventrikolari tax- xellug, bijopsija endomijokardika.
If a test result indicates possible cardiac injury associated with Caelyx therapy, the benefit of continued therapy must be carefully weighed against the risk of myocardial injury.
Jekk xi test juri dannu lill- qalb li jista ’ jkun marbut mat- terapija b’ Caelyx, il- benefiċċju li titkompla t- terapija għandu jitqies bir- reqqa f' konfront mar- riskju ta 'dannu mijokardijaku.
In patients with cardiac disease requiring treatment, administer Caelyx only when the benefit outweighs the risk to the patient.
F' pazjenti b' mard tal- qalb li jeħtieġu trattament, agħti Caelyx biss meta l- benefiċċju jegħleb ir- riskju lill- pazjent.
Exercise caution in patients with impaired cardiac function who receive Caelyx.
Oqgħod attent għal pazjenti b' tħaddim tal- qalb dgħajjef li jkunu qed jieħdu Caelyx.
Whenever cardiomyopathy is suspected, i. e., the left ventricular ejection fraction has substantially decreased relative to pre-treatment values and/ or left ventricular ejection fraction is lower than a prognostically relevant value (e. g. < 45%), endomyocardial biopsy may be considered and the benefit of continued therapy must be carefully evaluated against the risk of developing irreversible cardiac damage.
7 Meta jkun hemm suspett ta 'kardjomijopatija, jiġifieri l- frazzjoni ta' ħruġ ventrikolari tax- xellug ikun naqas sostanzjalment meta mqabbel mal- valuri ta 'qabel it- trattament u/ jew meta l- frazzjoni tal- ħruġ ventrikolari tax- xellug ikun anqas minn valur pronjostikament rilevanti (eż. < 45%), il- bijopsija endimijokardika tista' tiġi kkunsidrata u l- benefiċċju ta 'tkomplija tat- terapija għandu jitqies bir- reqqa fil- konfront mar- riskju ta' żvilupp ta 'dannu irreversibli fil- qalb.
7 Congestive heart failure due to cardiomyopathy may occur suddenly, without prior ECG changes and may also be encountered several weeks after discontinuation of therapy.
Insuffiċjenza tal- qalb konġestiva minħabba kardjomijopatija tista 'sseħħ għall- arrieda, mingħajr tibdil fl- ECG minn qabel u jista ’ jseħħ ukoll wara bosta ġimgħat li tkun intemmet it- terapija.
Caution must be observed in patients who have received other anthracyclines.
Wieħed għandu joqgħod attent rigward pazjenti li jkunu ngħataw anthrocyclines oħra.
The total dose of doxorubicin hydrochloride must also take into account any previous (or concomitant) therapy with cardiotoxic compounds such as other anthracyclines/ anthraquinones or e. g.
Id- doża totali ta 'doxorubicin hydrochloride għandha tinkludi wkoll kull terapija preċedenti (jew konkomitanti) li fiha sustanzi kardjotossiċi bħalma huma anthracyclines/ anthraquinones jew p. eż.
Cardiac toxicity also may occur at cumulative anthracycline doses lower than 450 mg/ m2 in patients with prior mediastinal irradiation or in those receiving concurrent cyclophosphamide therapy.
Il - kardjotossiċità tista 'sseħħ ukoll f' dożi kumulattivi ta' anthracycline ta 'anqas minn 450 mg/ m2 f' pazjenti li jkunu ħadu l- irradjazzjoni medjastinali jew dawk li jkunu qegħdin jieħdu wkoll terapija b’ cyclophosphamide.
The cardiac safety profile for the dosing schedule recommended for both breast and ovarian cancer (50 mg/ m2) is similar to the 20 mg/ m2 profile in patients with AIDS-KS (see section 4.8).
Il- profil ta 'sigurtà kardijaka għall- iskeda ta' dożaġġ irrakkomandata kemm għall- kanċer tas- sider kemm għal dak ta ’ l- ovarji (50 mg/ m2) hu simili għall- profil ta '20 mg/ m2 f' pazjenti bl- AIDS- KS (ara sezzjoni 4. 8)
Myelosuppression:
Majelosoppressjoni:
Many patients treated with Caelyx have baseline myelosuppression due to such factors as their pre-existing HIV disease or numerous concomitant or previous medications, or tumours involving bone marrow.
Ħafna pazjenti li jieħdu Caelyx ikollhom linja bażika ta ’ majelosoppressjoni minħabba fatturi bħalma huma mard HIV pri- eżistenti jew għadd kbir ta 'medikamenti konkomitanti jew preċedenti jew tumuri li jaffettwaw il- mudullun.
In the pivotal trial in patients with ovarian cancer treated at a dose of 50 mg/ m2, myelosuppression was generally mild to moderate, reversible, and was not associated with episodes of neutropaenic infection or sepsis.
Fil- provi pivitali f' pazjenti b' kanċer ovarju li ħadu trattament b' doża ta '50 mg/ m2, il- majelosoppressiv kien ġeneralment ħafif jew moderat, reversibbli u ma kienx marbut ma' episodji ta 'infezzjoni newtropenika jew sepsis.
Moreover, in a controlled clinical trial of Caelyx vs. topotecan, the incidence of treatment related sepsis was substantially less in the Caelyx-treated ovarian cancer patients as compared to the topotecan treatment group.
Barra minn dan f' provi kliniċi kkontrollati ta’ Caelyx vs. topotecan, l- inċidenza ta 'sepsis relatata mat- trattament kienet sostanzjalment anqas fil- pazjent b' kanċer ovarju ttrattati b’ Caelyx meta mqabbla mal- kategorija ta' pazjenti li ngħataw trattament b’ topotecan.
A similar low incidence of myelosuppression was seen in patients with metastatic breast cancer receiving Caelyx in a first-line clinical trial.
Inċidenza baxxa simili ta 'majelosoppressiv instab f' pazjenti b' kanċer tas- sider metastatiku li ngħataw Caelyx f' prova klinika tal- kura preferita.
In contrast to the experience in patients with breast cancer or ovarian cancer, myelosuppression appears to be the dose-limiting adverse event in patients with AIDS-KS (see section 4.8).
B' kuntrast ma 'l- esperjenza f' pazjenti li jbatu minn kanċer tas- sider jew ta ’ l- ovarji, il- majelosoppressjoni jidher li huwa l- effett mhux mixtieq li jillimita d- dożaġġ f' pazjenti bl- AIDS- KS (ara sezzjoni 4. 8).
Because of the potential for bone marrow suppression, periodic blood counts must be performed frequently during the course of Caelyx therapy, and at a minimum, prior to each dose of Caelyx.
Minħabba l - potenzjal ta 'soppressjoni tal- mudullun, l- għadd perijodiku taċ- ċelluli tad- demm għandu jsir ta' spiss waqt it- trattament b’ Caelyx, u ta 'l- anqas qabel kull doża ta' Caelyx.
Persistent severe myelosuppression, may result in superinfection or haemorrhage.
Majelosoppressjoni gravi u persistenti tista 'twassal għal superinfezzjoni jew fsada.
In controlled clinical studies in patients with AIDS-KS against a bleomycin/ vincristine regimen, opportunistic infections were apparently more frequent during treatment with Caelyx.
Fi studji kliniċi kkontrollati f' pazjenti bl- AIDS- KS mqabbla ma 'oħrajn ittrattati b' reġim ta' bleomycin/ vincristine, l- infezzjonijiet opportunistiċi dehru li kienu iżjed frekwenti fit- trattament b’ Caelyx.
Patients and doctors must be aware of this higher incidence and take action as appropriate.
Il- pazjenti u t- tobba għandhom ikunu konxji ta 'din l- inċidenza ogħla u jieħdu l- passi meħtieġa.
As with other DNA-damaging antineoplastic agents, secondary acute myeloid leukemias and myelodysplasias have been reported in patients having received combined treatment with doxorubicin.
Bħal ma jiġri b' sustanzi antinejoplastiċi oħra li jagħmlu ħsara fid- DNA, ġew rappurtati lewċemiji sekondarji majelodiċi akuti u majelojdisplażji f' pazjenti li jkunu ħadu trattament ikkombinat ma’ doxorubicin.
Therefore, any patient treated with doxorubicin should be kept under haematological supervision.
Għalhekk, kwalunkwe pazjent li jkun qed jingħata doxorubicin għandu jinżamm taħt superviżjoni ematoloġika.
Given the difference in pharmacokinetic profiles and dosing schedules, Caelyx should not be used interchangeably with other formulations of doxorubicin hydrochloride.
Minħabba d- differenza fil- profili farmakokinetiċi u skedi ta 'dożaġġ, Caelyx m' għandux jiġi sostitwit bl- istess mod ma ’ formulazzjonijiet oħra ta' doxorubicin hydrochloride.
Infusion-associated reactions:
Reazzjonijiet marbuta ma 'l- infużjoni:
Serious and sometimes life-threatening infusion reactions, which are characterised by allergic-like or anaphylactoid-like reactions, with symptoms including asthma, flushing, urticarial rash, chest pain, fever, hypertension, tachycardia, pruritus, sweating, shortness of breath, facial oedema, chills, back pain, tightness in the chest and throat and/ or hypotension may occur within minutes of starting the infusion of Caelyx.
Reazzjonijiet serji marbuta ma 'l- infużjoni u li xi kultant jheddu l- ħajja li huma kkaratteriżżati minn rejazzjonijiet bħal ta' l- allerġiji jew ta 'anafilaktojdiċi, b' sintomi li fosthom insibu l- ażżma, fwawar, raxx b’ urtikarja, uġigħ fis- sider, deni, pressjoni għolja, takikardija, ħakk, għaraq, qtugħ ta' nifs, edima fil- wiċċ, dehxiet, uġigħ fid- dahar, tagħfis fis- sider u fil- grieżem u/ jew pressjoni baxxa jistgħu jseħħu f' temp ta 'minuti minn meta tinbeda l- infużjoni b’ Caelyx.
Very rarely, convulsions also have been observed in relation to infusion reactions (see section 4.8).
Rari ħafna, konvulsjonijiet kienu relatati ma ’ reazzjonijiet ta ’ l- infużjoni (ara sezzjoni 4. 8).
Temporarily stopping the infusion usually resolves these symptoms without further therapy.
Il- waqfien ta 'l - infużjoni għal xi ħin is- soltu isib tarf dawn is- sintomi mingħajr terapija oħra.
However, medications to treat these symptoms (e. g., antihistamines, corticosteroids, adrenaline, and anticonvulsants), as well as emergency equipment should be available for immediate use.
Madankollu għandu jkun hemm lesti għall- użu immedjat il- mediċini għat- trattament ta 'dawn is- sintomi (eż. anti- istaminiċi,
In most patients treatment can be resumed after all symptoms have resolved, without recurrence.
Fil - biċċa l- kbira tal- pazjenti t- trattament jista 'jerġa jinbeda wara li s- sintomi kollha jkunu għebu, mingħajr ma jerġgħu jseħħu.
Infusion reactions rarely recur after the first treatment cycle.
Ir- reazzjonijiet għall- infużjoni rari jseħħu wara l- ewwel ċiklu ta 'trattament.
To minimise the risk of infusion reactions, the initial dose should be administered at a rate no greater than 1 mg/ minute (see section 4.2).
Biex jitnaqqas kemm jista 'jkun ir- riskju ta' reazzjonijiet għall- infużjoni l- ewwel doża għandha tingħata b' rata ta 'mhux aktar minn 1 mg/ minuta (ara sezzjoni 4. 2).
Diabetic patients:
Pazjenti dijabetiċi:
Please note that each vial of Caelyx contains sucrose and the dose is administered in 5% (50 mg/ ml) glucose solution for infusion.
Jekk jogħġbok innota illi kull kunjett ta 'Caelyx ikun fiha s- sucrose u li d- doża tingħata f' soluzzjoni ta' 5% (50 mg/ ml) glucose għall- infużjoni.
For common adverse events which required dose modification or discontinuation see section 4.8.
Għal każijiet avversi komuni li jeħtieġu tibdil fid- doża jew twaqqif ara sezzjoni 4. 8.
8 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
No formal medicinal product interaction studies have been performed with Caelyx, although phase II combination trials with conventional chemotherapy agents have been conducted in patients with gynaecological malignancies.
Ma sarux studji formali dwar nuqqas ta ’ qbil bejn prodotti mediċinali ma ’ Caelyx għalkemm provi ta 'kombinament tal- fażi II ma' sustanzi tal- kemoterapija konvenzjonali twettqu f' pazjenti b' forom ta ’ kanċer ġinekoloġiku.
Exercise caution in the concomitant use of medicinal products known to interact with standard doxorubicin hydrochloride.
Oqgħod attent meta jintuża flimkien ma 'prodotti mediċinali magħrufa li ma jaqblux ma’ doxorubicin hydrochloride standard.
Caelyx, like other doxorubicin hydrochloride preparations, may potentiate the toxicity of other anti-cancer therapies.
Bħal preparazzjonijiet b’ doxorubicin hydrochloride oħra, Caelyx jista 'jippotenzja t- tossiċità ta' terapiji kontra l- kanċer oħrajn.
During clinical trials in patients with solid tumours (including breast and ovarian cancer) who have received concomitant cyclophosphamide or taxanes, no new additive toxicities were noted.
F' provi kliniċi f' pazjenti li kellhom tumuri solidi (fosthom fis- sider u ovarji) li ngħataw fl- istess żmien cyclophosphamide jew taxanes, ma rriżultawx tossiċitajiet oħra ġodda.
In patients with AIDS, exacerbation of cyclophosphamide-induced haemorrhagic cystitis and enhancement of the hepatotoxicity of 6-mercaptopurine have been reported with standard doxorubicin hydrochloride.
F' pazjenti bl- AIDS ġie rrappurtat li tiħrax iċ- ċistite emorraġika indotta minn cyclophosphamide u żjieda fl- epatotossiċità ta ’ 6- mercatopurine meta jintuża doxorubicin hydrochloride standard.
Caution must be exercised when giving any other cytotoxic agents, especially myelotoxic agents, at the same time.
Wieħed għandu joqgħod attent meta jingħataw sustanzi ċitotossiċi oħra, speċjalment sustanzi majelotossiċi, fl- istess żmien.
Doxorubicin hydrochloride is suspected to cause serious birth defects when administered during pregnancy.
Huwa maħsub li doxorubicin hydrochloride jikkawża difetti gravi tat- twelid meta jingħata waqt it- tqala.
Therefore, Caelyx should not be used during pregnancy unless clearly necessary.
Għalhekk Caelyx m' għandux jintuża waqt it- tqala sakemm mhux meħtieġ.
Women of child-bearing potential must be advised to avoid pregnancy while they or their male partner are receiving Caelyx and in the six months following discontinuation of Caelyx therapy (see section 5.3).
Nisa ta 'età li jistgħu joħorġu tqal għandhom jitwissew biex jevitaw it- tqala waqt li huma jew seħibhom ikunu qed jieħdu Caelyx u fis- sitt xhur wara li jtemmu t- terapija b’ Caelyx (ara sezzjoni 5. 3).
Lactation:
Treddigħ:
It is not known whether Caelyx is excreted in human milk.
Mhux magħruf jekk Caelyx joħroġx mal- ħalib tas- sider.
Because many medicinal products, including anthracyclines, are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants, therefore mothers must discontinue nursing prior to beginning Caelyx treatment.
Minħabba li ħafna prodotti mediċinali, inklużi anthracyclines, joħorġu mal- ħalib tas- sider u minħabba li jista 'jkun hemm effetti mhux mixtieqa gravi fit- trabi li jkunu qed jitreddgħu, l- ommijiet għandhom jieqfu milli jreddgħu qabel ma jibdew trattament b’ Caelyx.
Health experts recommend that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Esperti tas- saħħa jirrakkomandaw illi nisa infettati bl- HIV ma jreddgħux lill- uliedhom f' kwalunkwe ċirkostanza biex ma jgħaddulhomx l- infezzjoni ta 'l- HIV.
Caelyx has no or negligible influence on the ability to drive and use machines.
Caelyx m’ għandu l- ebda effett, jew ftit li xejn għandu effett fuq il- ħila biex issuq u tħaddem magni.
However, in clinical studies to date, dizziness and somnolence were associated infrequently (< 5%) with the administration of Caelyx.
Madankollu, fl- istudji kliniċi li saru s' issa, l- istrudament u n- ngħas ġew assoċjati ma 'l- użu ta ’ Caelyx b' mod mhux frekwenti (< 5%).
Patients who suffer from these effects must avoid driving and operating machinery.
Pazjenti li jbatu minn dawn l- effetti għandhom jevitaw li jsuqu jew li jħaddmu magni.
The most common undesirable effect reported in breast/ ovarian clinical trials (50 mg/ m2 every 4 weeks) was palmar-plantar erythrodysesthesia (PPE).
L- effett mhux mixtieq l- iżjed komuni li ġie rrappurtat fil- provi kliniċi sider/ ovarji (50 mg/ m2 kull 4 ġimgħat) kien palmar- plantar erythrodysesthesia (PPE).
The overall incidence of PPE reported was 44.0% - 46.1%.
B' kollox l- inċidenza ta 'PPE rrappurtata kienet ta' 44. 0% - 46. 1%.
These effects were mostly mild, with severe (Grade III) cases reported in 17% - 19.5%.
Fil- biċċa l- kbira dawn l- effetti kienu ħfief, b' 17% - 19. 5% tal- każi rappurtati gravi (Grad III).
The reported incidence of life-threatening (Grade IV) cases was < 1%.
L- inċidenza ta 'każijiet li jheddu l- ħajja (Grad IV) kien < 1%.
PPE infrequently resulted in permanent treatment discontinuation (3.7% - 7.0%).
B' mod mhux frekwenti l- PPE wasslet għall- waqfien permanenti tat- trattament (3. 7% - 7. 0%).
PPE is characterised by painful, macular reddening skin eruptions.
Il- PPE hija kkaratteriżżata minn msiemer li jweġġgħu b' dbajja 'ħomor fil- ġilda.
In patients experiencing this event, it is generally seen after two or three cycles of treatment.
F' pazjenti li jġarrbu dan l- effett, narawh iseħħ ġeneralment wara żewġ ċikli jew tlieta ta 'trattament.
Improvement usually occurs in one - two weeks, and in some cases, may take up to 4 weeks or longer for complete resolution.
Iseħħ titjib is- soltu wara ġimgħa jew ħmistax, u f' xi każi jista ’ jdum sa 4 ġimgħat jew iżjed sakemm igħib għal kollox.
Pyridoxine at a dose of 50 - 150 mg per day and corticosteroids have been used for the prophylaxis and treatment of PPE, however, these therapies have not been evaluated in phase III trials.
Strateġiji oħra biex wieħed jagħti
Other strategies to prevent and treat PPE, which may be initiated for 4 to 7 days after treatment with Caelyx include keeping hands and feet cool, by exposing them to cool water (soaks, baths, or swimming), avoiding excessive heat/ hot water and keeping them unrestricted (no socks, gloves, or shoes that are tight fitting).
9 trattament jew jevita l- PPE u li jistgħu jinbdew minn 4 sa 7 ijiem wara trattament b’ Caelyx huma li l - idejn u s- saqajn jinżammu bierda billi jixxarbu bl- ilma kiesaħ (ħasil, banjijiet, għum), li jiġu evitati sħanat/ misħun żejjed u li jinżammu ħielsa (ma jintlibsux peduni, ingwanti jew żraben issikkati).
PPE appears to be primarily related to the dose schedule and can be reduced by extending the dose interval 1 - 2 weeks (see section 4.2).
Il - PPE jidher li hi marbuta primarjament ma 'l- iskeda tad- dożaġġ u tista' titaffa billi jittawwal l- intervall tad- dożaġġ b’ 1 - 2 ġimgħat (ara sezzjoni 4. 2).
However, this reaction can be severe and debilitating in some patients and may require discontinuation of treatment.
Madankollu dan l- effett jista 'jkun gravi f' xi pazjenti u jista' jkun jeħtieġ waqfien tat- trattament.
Stomatitis/ mucositis and nausea were also commonly reported in breast/ ovarian cancer patient populations, whereas the AIDS-KS Program (20 mg/ m2 every 2 weeks), myelosuppression (mostly leukopaenia) was the most common side effect (see AIDS-KS).
Stomatite/ mukożite u dardir ġew rappurtati komunement minn popolazzjonijiet ta 'pazjenti b' kanċer tas- sider/ ovarji waqt li fil- Programm AIDS- KS (20 mg/ m2 kull ħmistax) l- effett mhux mixtieq l- iżjed komuni kien il- majelosoppressjoni (prinċipalment lewkopenija) (ara AIDS- KS).
PPE was reported in 16% of multiple myeloma patients treated with Caelyx plus bortezomib combination therapy.
PPE kienet irrappurtata f’ 16% tal- pazjenti b’ majeloma multipla ikkurati b’ terapija kombinata ta ’ Caelyx flimkien ma ’ bortezomib.
Grade 3 PPE was reported in 5% of patients.
PPE ta ’ Grad 3 kienet irrappurtata f’ 5% tal - pazjenti.
The most frequently reported
L- ebda PPE ta ’ grad 4 ma kien irrappurtat.
9 (medicine-related treatment-emergent) adverse events in combination therapy (Caelyx + bortezomib) were nausea (40%), diarrhoea (35%), neutropaenia (33%), thrombocytopaenia (29%), vomiting (28%), fatigue (27%), and constipation (22%).
L- aktar każijiet avversi frekwenti li kienu rrappurtati (relatati mal- mediċina u ħarġu mal- kura) bit- terapija kombinata (Caelyx + bortezomib) kienu dardir (40%), dijarea (35%), newtropenija (33%), tromboċitopenija (29%), remettar (28%), għeja (27%), u stitikezza (22%).
Breast cancer program:
Programm Kanċer Tas- Sider:
37%; Grade III/ IV 5% vs.
509 pazjent b' kanċer tas- sider avvanzat li ma kienux ingħataw kemoterapija preċedenti għall- mard metastatiku, ngħataw trattament b’ Caelyx (n=254) b' doża ta '50 mg/ m2 kull 4 ġimgħat, jew doxorubicin (n=255) b' doża ta' 60 mg/ m2 kull 3 ġimgħat, f' prova klinika ta ’ fażi III (197- 328).
2%).
L- effetti mhux mixtieqa komuni li ġejjin ġew irrappurtati iżjed spiss b’ doxorubicin milli b’ Caelyx: dardir (53% vs 37%; Grad III/ IV 5% vs 3%), rimettar (31% vs 19%; Grad III/ IV 4% vs anqas minn 1%), alopeċja (66% vs 20%), alopeċja b’ mod evidenti (54% vs 7%) u newtropenja (10% vs 4% Grad III/ IV 8% vs 2%).
2%) were reported more commonly with Caelyx than with doxorubicin.
Il- mukożite (23% vs 13%; Grad III/ IV 4% vs 2%) u stomatite (22% vs 15%; Grad III/ IV 5% vs 2%) ġew irrappurtati iżjed spiss b’ Caelyx milli b’ doxorubicin.
The average duration of the most common severe (Grade III/ IV) events for both groups was 30 days or less.
It- tul ta ’ żmien medju ta 'l- avvenimenti l- iżjed komuni u gravi (Grad III/ IV) għaż- żewġ kategoriji kien ta' 30 jum jew anqas.
See Table 5 for complete listing of undesirable effects reported in Caelyx-treated patients.
Ara Tabella 5 għall- lista sħiħa ta 'effetti mhux mixtieqa rappurtati f' ≥ 5% tal- pazjenti ttrattati b’ Caelyx.
The incidence of life threatening (Grade IV) haematologic effects was < 1.0% and sepsis was reported in 1% of patients.
L- inċidenza ta 'effetti ematoloġiċi li jheddu l- ħajja (Grad IV) kienet < 1. 0% u sepsis ġie rrappurtat f' 1% tal- pazjenti.
Growth factor support or transfusion support was necessary in 5.1% and 5.5% of patients, respectively (see section 4.2).
Appoġġ tal- fattur tat- tkabbir jew appoġġ ta 'trasfużjoni kien meħtieġ f' 5. 1% u 5. 5% tal- pazjenti rispettivament (ara sezzjoni 4. 2).
Clinically significant laboratory abnormalities (Grades III and IV) in this group was low with elevated total bilirubin, AST and ALT reported in 2.4%, 1.6% and < 1% of patients respectively.
Anormalitajiet ta 'laboratorju klinikament sinifikanti (Gradi III u IV) f' dan il- grupp kienu baxxi, bil - bilirubin totali, AST u ALT għoljin rappurtati f' 2. 4%, 1. 6% u < 1% tal- pazjenti rispettivament.
No clinically significant increases in serum creatinine were reported.
L - ebda żidiet klinikament sinifikanti ta 'krejatinina fis- serum ma ġew irrappurtati.
10
10 Tabella 5.
Treatment Related Undesirable Effects Reported in Breast Cancer Clinical Trials (50 mg/ m2 every 4 weeks) (Caelyx-treated patients) by Severity, MedDRA System Organ Class and Preferred Term
Effetti mhux Mixtieqa Relatati mat- Trattament Rappurtati fi Provi Kliniċi ta 'Kanċer Tas- Sider (50 mg/ m2 kull 4 ġimgħat) (pazjenti trattati b’ Caelyx) skond is- Severità, Sistema MedDRA tal- Klassi ta ’ l- Organi tal- Ġisem u Terminoloġija Preferita Komuni ħafna (≥ 1/ 10); Komuni (≥ 1/ 100, < 1/ 10); Mhux komuni (≥ 1/ 1, 000, < 1/ 100) CIOMS III AE skond is- sistema
Very Common (≥ 1/ 10); Common (≥ 1/ 100, < 1/ 10); Uncommon (≥ 1/ 1,000, < 1/ 100) CIOMS III AE by body system
Kanċer tas- Sider Kanċer tas- Sider
Breast Cancer All Severities n=254
Kanċer tas- Sider
Breast Cancer Grades III/ IV n=254
Gradi III/ IV
previously reported in clinical trials
provi kliniċi
Common
infestazzjonijiet
Pharyngitis
Farinġite
Folliculitis, fungal infection, cold sores (non-herpetic), upper respiratory tract infection
Follikulite, infezzjoni
Uncommon Blood and lymphatic system disorders
Komuni Mhux komuni Disturbi tad- demm u tas- sistema limfatika Komuni
Common
tal- moffa, qsim tax - xofftejn (mhux bl- erpe), infezzjoni tas- sistema respiratorja tal- parti ta ’ fuq
Leukopaenia, anaemia, neutropaenia, thrombocytopaenia
Lewkopenja, anemija, newtropenja, tromboċitopenja
Leukopaenia, anaemia
Lewkopenja, anemija
Thrombocythemia
Tromboċitopenja
Uncommon Metabolism and nutrition disorders
Mhux komuni
Neutropaenia
Newtropenja
Very Common
Disturbi fil - metaboliżmu u n - nutrizzjoni Komuni ħafna
Anorexia
Anoressja
Common Nervous system disorders
Komuni Disturbi fis- sistema nervuża
Paresthesia
Parasteżija
Peripheral neuropathy
Newropatija periferika
Uncommon Eye Disorders
Mhux komuni Disturbi fl- għajnejn
Somnolence
Ngħas
Common Cardiac disorders
Komun Disturbi fil- qalb
Lacrimation, blurred vision
Dmugħ, viżjoni mċajpra
Common Respiratory, thoracic and mediastinal disorders
Komuni Disturbi respiratorji, toraċiċi u medjastinali Komuni
Ventricular arrhythmia
Arritmiji ventrikolari Faġra
11 Gastrointestinal disorders Very Common
11 Disturbi gastro - intestinali Komuni ħafna
Nausea, stomatitis, vomiting
Tqallih, stomatite, rimettar
Abdominal pain, constipation, diarrhoea, dyspepsia, mouth ulceration
Uġigħ addominali, stitikezza, dijarrea, dispepsja, ulċeri fil- ħalq
Abdominal pain, diarrhoea, nausea, stomatitis
Uġigħ addominali, dijarrea, tqallih, stomatite
Oral pain
Uġigħ fil- ħalq
Uncommon Skin and subcutaneous tissue disorders
Ulċeri fil- ħalq, Mhux komuni Disturbi fil- ġilda u fit - tessuti ta ’ taħt il- ġilda
Mouth ulceration, constipation, Vomiting
stitikezza, rimettar
Very Common
Komuni ħafna
PPE*, alopecia, rash
PPE *, alopeċja, raxx
Dry skin, skin discolouration, pigmentation abnormal, erythema
Ġilda xotta, il- ġilda titlef il- kulur, lewn tal - ġilda anormali, ħmura
Rash
Raxx
Bullous eruption, dermatitis, erythematous rash, nail disorder, scaly skin
Raxx b’ infafet u materja, dermatite, raxx bi ħmura, mard tad - dwiefer, ġilda bil- qxur
Uncommon Musculoskeletal and connective tissue disorders
Mhux komuni Disturbi muskolu - skeletrali u tal - connective tissue Komuni Disturbi fis- sistema riproduttiva u fis- sider Komuni Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata
Pigmentation abnormal, erythema
Lewn tal- ġilda mhux normali, ħmura
Leg cramps, bone pain, musculoskeletal pain
Bugħawwieġ, uġigħ fl - għadam, uġigħ muskolu- skeletali Uġigħ tas- sider
Asthenia, fatigue, mucositis NOS
Astenja, għejja, mard tal- membrana tal - mukoża NOS
Weakness, fever, pain
Dgħjufija, deni, uġigħ
Asthenia, mucositis NOS
Astenja, mard tal - membrana tal- mukoża, NOS
Oedema, leg oedema.
Edima, edema fir- riġlejn
Uncommon * palmar-plantar erythrodysesthesia (Hand- foot syndrome).
Mhux komuni
Fatigue, weakness, pain
Għejja, dgħjufija, uġigħ
Ovarian cancer program:
Programm Kanċer ta ’ l- ovarji:
512 patients with ovarian cancer (a subset of 876 solid tumour patients) were treated with Caelyx at a dose of 50 mg/ m2 in clinical trials.
512 pazjenta b' kanċer ta ’ l- ovarji (kategorija partikolari minn 867 pazjent b' tumuri solidi) ġew ittrattati b’ Caelyx b' doża ta '50 mg/ m2 f' provi kliniċi.
See Table 6 for undesirable effects reported in Caelyx-treated patients.
Ara Tabella 6 għall- effetti mhux mixtieqa rrappurtati f 'tal- pazjenti ttrattati b’ Caelyx.
Table 6 Treatment Related Undesirable Effects Reported in Ovarian Cancer Clinical Trials (50 mg/ m2 every 4 weeks) (Caelyx-treated patients) by Severity, MedDRA System Organ Class and Preferred Term Very Common (≥ 1/ 10); Common (≥ 1/ 100, < 1/ 10); Uncommon (≥ 1/ 1,000, < 1/ 100) CIOMS III
12 Tabella 6 Effetti mhux Mixtieqa Relatati mat- Trattament Rappurtati fi Provi Kliniċi tal- Kanċer Ovarju (50 mg/ m2 kull 4 ġimgħat) (Pazjenti ttrattati b’ Caelyx) Skond is- Severità, Sistema tal- Klassi ta’ l- Organi MedDRA u Terminoloġija Preferita Komuni ħafna (≥ 1/ 10); Komuni (≥ 1/ 100, < 1/ 10); Mhux komuni (≥ 1/ 1, 000, < 1/ 100) CIOMS III AE skond is -
12 AE by body system
sistema tal- ġisem
Ovarian Cancer n=512 (1-5%)
Infezzjonijiet u
Infections and infestations
infestazzjonijiet
Common
Farinġite
Pharyngitis
Komuni
Infection, oral moniliasis, herpes zoster, urinary tract infection
orali, herpes zoster, infezzjoni fis- sistema ta ’ l- awrina
Uncommon Blood and lymphatic system disorders
Mhux komuni Disturbi tad- demm u tas- sistema limfatika
Leukopaenia, anaemia, thrombocytopaenia
Lewkopenja, anemija, tromboċitopenja
Hypochromic anaemia
Anemija ipokromika
Immune system disorders
Disturbi fis- sistema immuni Komuni Disturbi fil - metaboliżmu u n - nutrizzjoni
Dehydration, cachexia
Disidratazzjoni, cachexia
Uncommon Psychiatric disorders
Mhux Komuni Disturbi psikjatriċi Komuni Disturbi fis- sistema nervuża
Anxiety, depression, insomnia
Ansjetà, dipressjoni, nuqqas ta ’ rqad
Paresthesia, somnolence
Parasteżija, ngħas
Headache, dizziness, neuropathy, hypertonia
Uġigħ ta ’ ras, sturdament, newropatija, ipertonija
Uncommon Eye disorders
Mhux komuni Disturbi fl- għajnejn Komuni Disturbi fil- qalb
Conjunctivitis
Konġunktivite
Vasodilatation
Mard kardjovaskulari
13 Respiratory, thoracic and mediastinal disorders Common
13 Disturbi vaskulari Komuni Disturbi respiratorji, toraċiċi u medjastinali
Dyspnoea, increased cough
Vażodilatazzjoni
Gastrointestinal disorders
Komuni
Constipation, diarrhoea, nausea, stomatitis, vomiting
Stitikezza, dijarrea, tqallih, stomatite, rimettar
Abdominal pain, dyspepsia, mouth ulceration
Uġigħ addominali, dispepsja, ulċeri fil- ħalq
Nausea, stomatitis, vomiting, abdominal pain, diarrhoea
Tqallih, stomatite, rimettar, uġigħ addominali, dijarrea
Mouth ulceration, esophagitis, nausea and vomiting, gastritis, dysphagia, dry mouth, flatulence, gingivitis, taste perversion
Ulċeri fil- ħalq, esofagite, tqallih u rimettar, gastrite, disfaġja, ħalq xott, gass fl- istonku, ġenġivite, perverżjoni tat- togħma
Uncommon Skin and subcutaneous tissue disorders
Mhux komuni Disturbi fil- ġilda u fit- tessuti ta ’ taħt il - ġilda
Constipation, dyspepsia, mouth ulceration
Stitikezza, dispepsja, ulċeri fil- ħalq
Common Musculoskeletal and connective tissue disorders
Komuni Disturbi muskolu - skeletrali u tal - connective tissue Komuni Disturbi fil- kliewi u fis- sistema urinarja Komuni Disturbi fis- sistema riproduttiva u fis - sider Komuni
Dry skin, skin discolouration
Ġilda xotta, il- ġilda titlef il- kulur
Alopecia, rash
Alopeċja, raxx
Vesiculobullous rash, pruritus, exfoliative dermatitis, skin disorder, maculopapular rash, sweating, acne, skin ulcer
Raxx b’ infafet u materja, ħakk, dermatite esfoljattiva, mard tal- ġilda, raxx makulopapulari, għaraq, akne, ulċera tal - ġilda Uġigħ fid- dahar, majalġja Tbatija biex tgħaddi l - awrina Vaġinite
Common General disorders and administration site conditions
14 Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata Komuni ħafna
Asthenia, mucous membrane disorder
Astenja, mard tal - membrana tal- mukoża
Fever, pain
Deni, uġigħ
Asthenia, mucous membrane disorder, pain
Astenja, mard tal - membrana tal- mukoża, uġigħ
Chills, chest pain, malaise, peripheral oedema
Dehxiet, uġigħ tas - sider, ħass ħażin, edima periferali
Uncommon
Mhux komuni Deni Investigazzjonijiet Komuni
14 Investigations Common
Nuqqas fil- piż tal - ġisem
* palmar-plantar erythrodysesthesia (Hand- foot syndrome).
* palmar- plantar erythrodysesthesia (Sindrome ta’ l- Id u tal- pala tas- Sieq).
Myelosuppression was mostly mild or moderate and manageable.
Majelosopprissjoni kienet fil- biċċa l- kbira ħafifa jew moderata u maniġġevoli.
Sepsis related to leukopaenia was observed infrequently (< 1%).
Sepsis relatata mal - lewkopenja dehret b’ mod mhux frekwenti (< 1%).
Growth factor support was required infrequently (< 5%) and transfusion support was required in approximately 15% of patients (see section 4.2).
Support b’ fattur tat- tkabbir kien meħtieġ b’ mod mhux frekwenti (< 5%) u support b’ trasfużjoni kien meħtieġ f’ madwar 15% tal- pazjenti (ara sezzjoni 4. 2).
In a subset of 410 patients with ovarian cancer, clinically significant laboratory abnormalities occurring in clinical trials with Caelyx included increases in total bilirubin (usually in patients with liver metastases) (5%) and serum creatinine levels (5%).
F' kategorija partikolari 410 pazjenta b' kanċer ta ’ l- ovarji, l- abnormalitajiet tal- laboratorju klinikament sinifikanti li seħħu f' provi kliniċi b’ Caelyx kienu jinkludu żieda ta 'bilirubin totali (ġeneralment f' pazjenti b' metastasi fil- fwied) (5%) u żjieda fil- livelli ta ’ krejatinina fis- serum (5%).
Increases in AST were less frequently (< 1%) reported.
Żiediet fl- AST kienu rrappurati anqas frekwenti (< 1%).
Solid tumour patients: in a larger cohort of 929 patients with solid tumours (including breast cancer and ovarian cancer) predominantly treated at a dose of 50 mg/ m2 every 4 weeks, the safety profile and incidence of adverse effects are comparable to those of the patients treated in the pivotal breast cancer and ovarian cancer trials.
Pazjenti b' tumuri solidi: f' grupp akbar ta '929 pazjent b' tumuri solidi (fosthom kanċer tas- sider u ovarju) il- biċċa l- kbira ttrattati b' doża ta' 50 mg/ m2 kull 4 ġimgħat, il- profil ta 'sigurtà u inċidenza ta' effetti mhux mixtieqa jistgħu jitqabblu ma 'dawk ta' pazjenti ttrattati f' provi kliniċi pivotali dwar kanċer tas- sider u ta ’ l- ovarji.
Multiple Myeloma program:
Programm Majeloma Multipla:
Of 646 patients with multiple myeloma who have received at least 1 prior therapy, 318 patients were treated with combination therapy of Caelyx 30 mg/ m2 as a one hour intravenous infusion administered on day 4 following bortezomib which is administered at 1.3 mg/ m² on days 1, 4, 8, and 11, every three weeks or with bortezomib monotherapy in a phase III clinical trial.
Mis- 646 pazjent b’ majeloma multipla li rċevew mill- anqas terapija waħda minn qabel, 318- il pazjent kienu ikkurati b’ terapija kombinata b’ Caelyx 30 mg/ m2 bħala infużjoni ġol- vina ta ’ siegħa mogħtija f’ jum 4 wara bortezomib li jingħata b’ 1. 3 mg/ m2 f’ jiem 1, 4, 8, u 11, kull tlett ġimgħat jew b’ monoterapija b’ bortezomib fi prova klinika ta ’ fażi III.
See Table 7 for adverse effects reported in ≥ 5% patients treated with combination therapy of Caelyx plus bortezomib.
Ara Tabella 7 għall- effetti avversi irrappurtati f’ ≥ 5% tal- pazjenti kkurati b’ terapija kombinata b’ Caelyx ma ’ bortezomib.
Neutropaenia, thrombocytopaenia, and anaemia were the most frequently reported hematologic events reported with both combination therapy of Caelyx plus bortezomib and bortezomib monotherapy.
Newtropenija, tromboċitopenija, u anemija kienu l- każijiet ematoloġiċi rrapurtati bl- aktar mod frekwenti kemm b’ terapija kombinata b’ Caelyx ma ’ bortezomib kif ukoll b’ monoterapija b’ bortezomib.
The incidence of grade 3 and 4 neutropaenia was higher in the combination therapy group than in the monotherapy group (28% vs.
L- inċidenza ta ’ newtropenija ta ’ grad 3 u 4 kienet ogħla fil- grupp b’ terapija kombinata milli fil- grupp b’ monoterapija (28% vs.
The incidence of grade 3 and 4 thrombocytopaenia was higher in the combination therapy group than in the monotherapy group (22% vs.
L- inċidenza ta ’ tromboċitopenija ta ’ grad 3 u 4 kienet ogħla fil- grupp b’ terapija kombinata milli fil- grupp b’ monoterapija (22% vs.
The incidence of anaemia was similar in both treatment groups (7% vs.
L- inċidenza ta ’ anemija kienet simili fiż- żewġ gruppi ta ’ kura (7% vs.
Stomatitis was reported more frequently in the combination therapy group (16%) than in the monotherapy group (3%), and most cases were grade 2 or less in severity.
Stomatite kienet irrappurtata b’ mod aktar frekwenti fil- grupp b ’ terapija kombinata (16%) milli fil - grupp b’ monoterapija (3%), u fil- parti l- kbira, l- każijiet kellhom severità ta ’ grad 2 jew anqas.
Grade 3 stomatitis was reported in 2% of patients in the combination therapy group.
Stomatite ta ’ grad 3 kienet irrappurtata f’ 2% tal- pazjenti fil- grupp b’ terapija kombinata.
No grade 4 stomatitis was reported.
L- ebda stomatite ta ’ grad 4 ma kienet irrappurtata.
Nausea and vomiting were reported more frequently in the combination therapy group (40% and 28%) than in the monotherapy group (32% and 15%) and were mostly grade 1 and 2 in severity.
Dardir u rimettar kienu rrappurtati b’ mod aktar frekwenti fil- grupp b’ terapija kombinata (40% u 28%) milli fil- grupp b’ monoterapija (32% u 15%) u kienu l- aktar ta ’ grad 1 u 2 fis- severità tagħhom.
Treatment discontinuation of one or both agents due to adverse events was seen in 38% of patients.
Twaqqif tal- kura ta ’ wieħed jew iż- żewġ aġenti minħabba każijiet avversi dehret f’ 38% tal- pazjenti.
Common adverse events which led to treatment discontinuation of bortezomib and Caelyx included PPE, neuralgia, peripheral neuropathy, peripheral sensory neuropathy, thrombocytopaenia, decreased ejection fraction, and fatigue.
15 nevralġja, newropatija periferali, newropatija sensorjali periferali, tromboċitopenija, tnaqqis fil - frazzjoni tal- ħruġ, u għeja.
Table 7.
Tabella 7
Treatment Related Undesirable Effects Reported in Multiple Myeloma Clinical Trial (Caelyx 30 mg/ m2 in combination with bortezomib every 3 weeks) by Severity, MedDRA System Organ Class and Preferred Term Very Common (≥ 1/ 10); Common (≥ 1/ 100, < 1/ 10); Uncommon (≥ 1/ 1,000, < 1/ 100) CIOMS III AE by body system
b’ Majeloma Multipla Caelyx 30 mg/ m2 f’ kombinazzjoni ma ’ bortezomib kull 3 ġimgħat) skond is- Severità, Klassi tas- Sistema ta ’ l- Organi MedDRA u Terminu Preferit Komuni ħafna (≥ 1/ 10); Komuni (≥ 1/ 100, < 1/ 10); Mhux komuni (≥ 1/ 1, 000, < 1/ 100) CIOMS III AE skond is- sistema
All Severities n=318
Is- severitajiet kollha
Grades III/ IV** n=318
Gradi III/ IV **
All
tal- ġisem
15 Infections and infestations Common Blood and lymphatic system disorders
Komuni Disturbi tad- demm u tas- sistema limfatika
Pneumonia, nasopharyngitis, upper respiratory tract infection, oral candidiasis
Pulmonite, nażofarinġite, infezzjoni fil- passaġġ respiratorju ta ’ fuq, kandidijażi orali
Anaemia, neutropaenia, thrombocytopaenia
Anemija, newtropenja, tromboċitopenja
Neutropaenia, thrombocytopaenia
Newtropenja, tromboċitopenja
Common Metabolism and Nutrition disorders
Komuni Disturbi fil - metaboliżmu u n - nutrizzjoni
Leukopaenia
Lewkopenja
Anaemia, leukopaenia
Anemija, lewkopenija
Febrile neutropaenia, lymphopaenia
Newtropenja bid- deni, limfopenija
Anorexia
Anoressija
Decreased appetite
L- aptit jonqos
Dehydration, hypokalaemia, hyperkalaemia, hypomagnesaemia, hyponatraemia, hypocalcaemia
Deidrazzjoni, ipokalimja, iperkalimja, ipomagneżimja, iponatrimja, ipokalċemija
Uncommon Psychiatric disorders
Mhux komuni Disturbi psikjatriċi
Anxiety
Ansjetà
Peripheral sensory neuropathy, neuralgia, headache
Newropatija sensorjali periferali, nevralġja, uġigħ ta ’ ras
Neuropathy peripheral, neuropathy, paraesthesia, polyneuropathy, dizziness, dysgeusia
Newropatija periferali, newropatija, parasteżija, polinewropatija, sturdament, tibdil fit - togħma
Neuralgia, peripheral neuropathy, neuropathy
Nevralġja, newropatija periferali, newropatija
Lethargy, hypoaesthesia, syncope, dysaesthesia
Letarġija, ipoesteżija, sinkope, disesteżija
Uncommon Eye disorders
Mhux komuni Disturbi fl- għajnejn Komuni
Headache, peripheral sensory neuropathy, paraesthesia, dizziness
Uġigħ ta ’ ras, newropatija sensorjali periferali, parasteżija, sturdament
16 Respiratory, thoracic, and mediastinal disorders Common
16 Disturbi vaskulari Komuni Disturbi respiratorji, toraċiċi u medjastinali
Dyspnoea
Komuni
Cough, epistaxis exertional dyspnoea
Sogħla, epistassi, qtugħ ta ’ nifs bl- isforz
Uncommon Gastrointestinal disorders
Mhux komuni Disturbi gastro - intestinali
Dyspnoea
Qtugħ ta ’ nifs
Nausea, diarrhoea, vomiting, constipation, stomatitis
Dardir, dijarea, rimettar, stitikezza, stomatite
Abdominal pain, dyspepsia
Uġigħ fil- parti ta ’ fuq ta ’ l -
Nausea, diarrhoea, vomiting, stomatitis
rimettar, stomatite
Upper abdominal pain, mouth ulceration, dry mouth, dysphagia, aphthous stomatitis
addome, ulċeri fil- ħalq, ħalq xott, uġigħ meta tibla ’, stomatite bi dbabar
Constipation, abdominal pain, dyspepsia
Stitikezza, uġigħ fl - addome, dispepsja
PPE*, rash
PPE *, raxx
Dry skin
Ġilda xotta
Pruritus, papular rash, allergic dermatitis, erythema, skin hyperpigmentation, petechiae, alopecia, medicine eruption
Ħakk, raxx papulari, dermatite allerġika, ħmura, iperpigmentazzjoni tal - ġilda, ponot ħomor, alopeċja, eruzzjoni tal - mediċina
Uncommon Musculoskeletal and connective tissue disorders
Mux komuni Disturbi muskolu - skeletrali u tal - connective tissue
Common Reproductive system and breast disorders
Komuni
Pain in extremity
Uġigħ fl- estremitajiet
Arthralgia, myalgia, muscle spasms, muscular weakness, musculoskeletal pain, musculoskeletal chest pain
Artralġja, mijalġja, spasmi fil- muskoli, dgħjufija fil - muskoli, uġigħ muskoluskeletali, uġigħ muskoluskeletali fis- sider
Common General disorders and administration site conditions
Disturbi fis- sistema riproduttiva u fis - sider Komuni
Scrotal erythema
Ħmura ta’ l- iskrotu
Very Common
17 Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata Komuni ħafna
Asthenia, fatigue, pyrexia
Astenja, għeja, deni
Asthenia, fatigue
Astenja, għeja
Peripheral oedema, chills, influenza-like illness, malaise, hyperthermia
Edema periferali, dehxiet, mard bħal influwenza, tħossok ma tiflaħx, ipertermija
Uncommon
Mhux komuni Investigazzjonijiet
Pyrexia
Deni
17 Investigations Common
Komuni
Weight decreased
Tnaqqis tal- piż
Aspartate aminotransferase increased, ejection fraction decreased, blood creatinine increased, alanine aminotransferase increased
Żieda ta ’ aspartate aminotransferase, tnaqqis fil- frazzjoni tal- ħruġ, żieda tal- krejatinina fid- demm, żieda ta ’ l- alanine aminotransferase
* Palmar-plantar erythrodysesthesia (Hand-foot syndrome). ** Grade 3/ 4 adverse events are based on the adverse event terms of all severities with an overall incidence ≥ 5% (see adverse events listed in first column).
* Palmar- plantar erythrodysesthesia (Sindrome ta ’ l- Id- Sieq). ** Każijiet avversi ta ’ Grad 3/ 4 huma bbażati fuq it- termini tal- każijiet avversi tas- severitajiet kollha b’ inċidenza globali ta ’ > 5% (ara l- każijiet avversi elenkati fl- ewwel kolonna).
AIDS-KS program:
Programm AIDS- KS:
Clinical studies on AIDS-KS patients treated at 20 mg/ m2 with Caelyx show that myelosuppression was the most frequent undesirable effect considered related to Caelyx occurring very commonly (in approximately one-half of the patients).
Studji kliniċi fuq pazjenti bl- AIDS- KS ittrattati b' 20 mg/ m2 ta’ Caelyx juru li l - majelosoppressjoni kien l- effett mhux mixtieq l- iżjed frekwenti meqjuż li kien relatat ma’ Caelyx li seħħ l- aktar (f' bejn wieħed u ieħor, nofs il- pazjenti).
Leukopaenia is the most frequent undesirable effect experienced with Caelyx in this population; neutropaenia, anaemia and thrombocytopaenia have been observed.
Lewkopenja hija l- effett mhux mixtieq l- iżjed frekwenti li ġarrbet din il- popolazzjoni b’ Caelyx; newtropenja, anemija u trombocitopenja ġew osservati.
These effects may occur early on in treatment.
Dawn l- effetti jistgħu jseħħu fil- parti bikrija tat- trattament.
Haematological toxicity may require dose reduction or suspension or delay of therapy.
It- tossiċità ematoloġika tista 'tinħtieġ tnaqqis fid- doża jew waqfien jew tlajjar tat - terapija.
Temporarily suspend Caelyx treatment in patients when the ANC count is < 1,000/ mm3 and/ or the platelet count is < 50,000/ mm3.
Waqqaf it- trattament b’ Caelyx temporanjament f' pazjenti li jkollhom l- għadd ANC < 1, 000/ mm3 u/ jew l- għadd tal- plejtlets ikun < 50, 000/ mm3.