qanastek/EMEA-V3 huggingface dataset:
Both 70 mg and 50 mg vials are available.
Huma disponibbli kunjetti kemm ta ’ 70 mg kif ukoll ta ’ 50 mg.
CANCIDAS should be given as a single daily infusion.
CANCIDAS għandu jingħata bħala infużjoni waħda kuljum.
Dosage in adult patients A single 70 mg loading dose should be administered on Day-1, followed by 50 mg daily thereafter.
Dożaġġ f’ pazjenti anzjani Fl- ewwel jum għandha tingħata loading dose waħda ta ’ 70 mg, li mbagħad tkun segwita minn 50 mg kuljum.
In patients weighing more than 80 kg, after the initial 70 mg loading dose, CANCIDAS 70 mg daily is recommended (see section 5.2).
F’ pazjenti li jiżnu aktar minn 80 kg, wara l- loading dose inizjali ta ’ 70 mg, huwa rakkomandat CANCIDAS 70 mg kuljum (ara sezzjoni 5. 2).
Doses higher than 70 mg daily have not been adequately studied.
Għadhom ma ġewx studjati dożi akbar minn 70 mg kuljum.
No dosage adjustment is necessary based on gender or race (see section 5.2).
M’ hemmx bżonn ta ’ aġġustament fid- doża bbażat fuq is- sess tal- persuna jew ir- razza (ara sezzjoni 5. 2).
2 Dosage in paediatric patients (12 months to 17 years) In paediatric patients (12 months to 17 years of age), dosing should be based on the patient’ s body surface area (see Instructions for Use in Paediatric Patients, Mosteller 1 Formula).
2 Dożaġġ f’ pazjenti pedjatriċi (12- il xahar sa 17- il sena) F’ pazjenti pedjatriċi (12- il xahar sa 17- il sena), id- doża għandha tkun ibbażata fuq l- arja tas- superfiċje tal- ġisem tal- pazjent (ara l- Istruzzjonijiet għall- Użu f’ Pazjenti Pedjatriċi, Formula Mosteller 1).
For all indications, a single 70-mg/ m2 loading dose (not to exceed an actual dose of 70 mg) should be administered on Day 1, followed by 50 mg/ m2 daily thereafter (not to exceed an actual dose of 70 mg daily).
Għall - indikazzjonijiet kollha, għandha tingħata loading dose waħda ta ’ 70- mg/ m2 (li ma taqbiżx doża attwali ta ’ 70 mg), segwita wara b’ 50 mg/ m2 kuljum (li m’ għandhiex taqbeż doża attwali ta ’ 70 mg kuljum).
If the 50- mg/ m2 daily dose is well tolerated but does not provide an adequate clinical response, the daily dose can be increased to 70 mg/ m2 daily (not to exceed an actual daily dose of 70 mg).
Jekk id- doża ta ’ 50- mg/ m2 kuljum tkun ittollerata tajjeb iżda ma tipprodix rispons kliniku adegwat, id - doża tal- ġurnata tista ’ tiżdied għal 70 mg/ m2 (li m’ għandhiex taqbeż doża attwali ta ’ 70 mg kuljum).
The efficacy and safety of CANCIDAS have not been sufficiently studied in clinical trials involving neonates and infants below 12 months of age.
L- effikaċja u s- sigurtà ta ’ CANCIDAS ma ġewx studjati biżżejjed fi provi kliniċi li kienu jinvolvu trabi għadhom jitwieldu u trabi ta ’ inqas minn 12- il xahar.
Caution is advised when treating this age group.
Hija rakkomandata kawtela fit - trattament ta ’ dan il- grupp ta ’ età.
Limited data suggest that CANCIDAS at 25 mg/ m2 daily in neonates and infants (less than 3 months of age) and 50 mg/ m2 daily in young children (3 to 11 months of age) can be considered (see section 5.2).
Tagħrif limitat jissuġġerixxi li CANCIDAS f’ doża ta ’ 25 mg/ m2 kuljum fi trabi għadhom jitwieldu u trabi (ta ’ inqas minn 3 xhur) u 50 mg/ m2 kuljum fi tfal żgħar (3 sa 11- il xahar) jista ’ jiġi kkunsidrat (ara sezzjoni 5. 2).
Duration of treatment Duration of empirical therapy should be based on the patient’ s clinical response.
Tul tat- trattament It- tul tat- terapija empirika għandu jkun ibbażat fuq ir- rispons kliniku tal- pazjent.
Therapy should be continued until up to 72 hours after resolution of neutropaenia (ANC≥ 500).
It- terapija għandha tissokta sa 72 siegħa wara s- solvien tan- newtropenija (ANC≥500).
Patients found to have a fungal infection should be treated for a minimum of 14 days and treatment should continue for at least 7 days after both neutropaenia and clinical symptoms are resolved.
Il- pazjenti misjuba li għandhom infezzjoni fungali għandhom jiġu kkurati għal minimu ta ’ 14- il jum u t- trattament għandu jissokta għal mill- anqas 7 ijiem wara li kemm in- newtropenija kif ukoll is- sintomi kliniċi jitilqu.
Duration of treatment of invasive candidiasis should be based upon the patient’ s clinical and microbiological response.
It- tul tat- trattament ta ’ kandidjasi invażiva għandu jkun ibbażat fuq ir- rispons kliniku u mikrobijoloġiku tal- pazjent.
After signs and symptoms of invasive candidiasis have improved and cultures have become negative, a switch to oral antifungal therapy may be considered.
Wara li s- sinjali u s- sintomi ta ’ kandidjasi invażiva jitjiebu u l- kulturi jkunu saru negattivi, tista ’ tiġi kkunsidrata bidla għal terapija antifungali orali.
In general, antifungal therapy should continue for at least 14 days after the last positive culture.
B’ mod ġenerali, it - terapija antifungali għandha tissokta għal mill- anqas 14- il jum wara l- aħħar kultura pożittiva.
Duration of treatment of invasive aspergillosis is determined on a case by case basis and should be based upon the severity of the patient’ s underlying disease, recovery from immunosuppression, and clinical response.
It- tul tat- trattament ta ’ asperġillożi invażiva jiġi determinat fuq il- bażi ta ’ kull każ individwali u għandu jkun ibbażat fuq is- severità tal- marda sottostanti tal- pazjent, l- irkupru mill - immunosuppressjoni, u r- rispons kliniku.
In general, treatment should continue for at least 7 days after resolution of symptoms.
B’ mod ġenerali, it- trattament għandu jissokta għal mill - anqas 7 ijiem wara l- għibien tas- sintomi.
Dosage in elderly patients In elderly patients (65 years of age or more), the area under the curve (AUC) is increased by approximately 30%.
Dożaġġ f’ pazjenti anzjani Fil- pazjenti adulti (65 sena jew aktar), l- erja taħt il- kurva (AUC) tiżdied b’ madwar 30%.
However, no systematic dosage adjustment is required.
Madankollu, m’ hemm bżonn ta ’ ebda aġġustament sistematiku fid- doża.
There is limited treatment experience in patients 65 years of age and older.
Hemm esperjenza limitata ta ’ trattament f’ pazjenti ta ’ 65 sena u aktar.
Dosage in patients with renal impairment No dosage adjustment is necessary based on renal impairment (see section 5.2).
Dożaġġ f’ pazjenti b’ indeboliment tal- kliewi M’ hemmx bżonn ta ’ aġġustament fid- doża minħabba indeboliment tal- kliewi (ara sezzjoni 5. 2).
Dosage in patients with hepatic insufficiency For adult patients with mild hepatic insufficiency (Child-Pugh score 5 to 6), no dosage adjustment is needed.
Dożaġġ f’ pazjenti b’ insuffiċjenza tal- fwied M’ hemmx bżonn ta ’ aġġustament fid- doża għal pazjenti adulti b’ insuffiċjenza epatika ħafifa (punteġġ Child- Pugh 5 sa 6).
For adult patients with moderate hepatic insufficiency (Child-Pugh score 7 to 9), CANCIDAS 35 mg daily is recommended based upon pharmacokinetic data.
Fil- każ ta ’ pazjenti adulti b’ insuffiċjenza epatika moderata (punteġġ Child- Pugh 7 sa 9), huwa rakkomandat CANCIDAS 35 mg kuljum skont informazzjoni farmakokinetika.
An initial 70 mg loading dose should be administered on Day-1.
Fl- ewwel jum għandha tingħata doża inizjali ta ’ 70 mg.
(see section 4.4).
M’ hemmx esperjenza klinika f’ pazjenti adulti b’ insuffiċjenza epatika severa (punteġġ Child- Pugh akbar minn 9) u f’ pazjenti pedjatriċi bi kwalunkwe livell ta ’ insuffiċjenza tal- fwied (ara sezzjoni 4. 4).
Co-administration with inducers of metabolic enzymes Limited data suggest that an increase in the daily dose of CANCIDAS to 70 mg, following the 70 mg loading dose, should be considered when co-administering CANCIDAS in adult patients with certain inducers of metabolic enzymes (see section 4.5).
Għoti fl- istess ħin ma ’ indutturi ta ’ enzimi metaboliċi Informazzjoni limitata tissuġġerixxi li għandha tiġi kkunsidrata żieda fid- doża ta ’ kuljum ta ’ CANCIDAS għal 70 mg, wara l- loading dose ta ’ 70 mg, meta CANCIDAS jingħata f’ pazjenti adulti fl- istess ħin ma ’ ċerti indutturi ta ’ enzimi metaboliċi (ara sezzjoni 4. 5).
When CANCIDAS is co-administered to paediatric patients (12 months to 17 years of age) with these same inducers of metabolic enzymes (see section 4.5), a CANCIDAS dose of 70-mg/ m2 daily (not to exceed an actual daily dose of 70 mg) should be considered.
Meta CANCIDAS jingħata lil pazjenti pedjatriċi (12- il xahar sa 17- il sena) fl- istess ħin ma ’ dawn l- istess indutturi ta ’ enzimi metaboliċi (ara sezzjoni 4. 5), għandha tiġi kkunsidrata doża ta ’ CANCIDAS ta ’ 70- mg/ m2 kuljum (li m’ għandhiex taqbeż doża attwali ta ’ 70 mg kuljum).
3 4.3 Contraindications
3 4. 3 Kontra- indikazzjonijiet
Limited data suggest that less common non-Candida yeasts and non-Aspergillus moulds are not covered by caspofungin.
Informazzjoni limitata tissuġġerixxi li ħmejjer mhux Candida u mofof mhux Aspergillus inqas komuni mhumiex koperti minn caspofungin.
The efficacy of caspofungin against these fungal pathogens has not been established.
L- effikaċja ta ’ caspofungin kontra dawn il- patoġeni fungali ma ġietx stabbilita.
Concomitant use of CANCIDAS with cyclosporin has been evaluated in healthy adult volunteers and in adult patients.
L- użu konkomitanti ta ’ CANCIDAS ma ’ cyclosporin ġie evalwat f’ voluntiera adulti b’ saħħithom u f’ pazjenti adulti.
Some healthy adult volunteers who received two 3 mg/ kg doses of cyclosporin with caspofungin showed transient increases in alanine transaminase (ALT) and aspartate transaminase (AST) of less than or equal to 3-fold the upper limit of normal (ULN) that resolved with discontinuation of the treatment.
Xi voluntiera adulti b’ saħħithom li rċevew żewġ dożi ta ’ 3 mg/ kg ta ’ cyclosporin ma ’ caspofungin urew żidiet għaddiena fl- alanine transaminase (ALT) u fl- aspartate transaminase (AST) ta ’ inqas minn jew ugwali għal tliet darbiet il- limitu ta ’ fuq tan- normal (ULN) li telqu bit- twaqqif tat - trattament.
In a retrospective study of 40 patients treated during marketed use with CANCIDAS and cyclosporin for 1 to 290 days (median 17.5 days), no serious hepatic adverse events were noted.
Fi studju retrospettiv ta ’ 40 pazjent ittrattati waqt l- użu kummerċjalizzat b’ CANCIDAS u cyclosporin għal 1 sa 290 ġurnata (medjan 17. 5 ġurnata), ma ġew innotati ebda episodji avversi serji fil- fwied.
These data suggest that CANCIDAS can be used in patients receiving cyclosporin when the potential benefit outweighs the potential risk.
Din l- informazzjoni tissuġġerixxi li CANCIDAS jista ’ jintuża f’ pazjenti li jkunu qegħdin jirċievu cyclosporin meta l- benefiċċju li jista ’ jkun hemm ikun akbar mir- riskju li jista ’ jkun hemm.
Close monitoring of liver enzymes should be considered if CANCIDAS and cyclosporin are used concomitantly.
Għandu jiġi kkunsidrat monitoraġġ mill- viċin tal- enzimi tal- fwied jekk CANCIDAS u cyclosporin jintużaw flimkien.
In adult patients with mild and moderate hepatic impairment, the AUC is increased about 20 and 75%, respectively.
F’ pazjenti adulti b’ indeboliment ħafif u moderat tal- fwied, l- AUC tiżdied madwar 20 u 75%, rispettivament.
A reduction of the daily dose to 35 mg is recommended for adults with moderate hepatic impairment.
Huwa rakkomandat tnaqqis fid- doża ta ’ kuljum għal 35 mg għall- adulti li jkollhom indeboliment moderat tal- fwied.
There is no clinical experience in adults with severe hepatic insufficiency or in paediatric patients with any degree of hepatic insufficiency.
M’ hemmx esperjenza klinika f’ pazjenti adulti b’ insuffiċjenza epatika severa jew f’ pazjenti pedjatriċi b’ xi livell ta ’ insuffiċjenza tal- fwied.
A higher exposure than in moderate hepatic insufficiency is expected and CANCIDAS should be used with caution in these patients (see sections 4.2 and 5.2).
Huwa mistenni esponimen akbar milli f’ insuffiċjenza tal- fwied moderata u CANCIDAS għandu jintuża b’ kawtela f’ dawn il- pazjenti (ara sezzjonijiet 4. 2 u 52.).
The safety information on treatment durations longer than 4 weeks is limited.
L- informazzjoni dwar is- sigurtà fir- rigward ta ’ trattamenti ta ’ iżjed minn 4 ġimgħat hija limitata.
This medicinal product contains sucrose.
Dan il- prodott mediċinali fih is- sucrose.
Patients with rare hereditary problems of fructose intolerance or sucrase– isomaltase insufficiency should not take this medicinal product.
Pazjenti bi problemi ereditarji rari ta ’ intolleranza għall - fructose jew insuffiċjenza ta ’ sucrase- isomaltase m’ għandhomx jieħdu dan il- prodott mediċinali.
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 affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Studies in vitro show that caspofungin acetate is not an inhibitor of any enzyme in the cytochrome P450 (CYP) system.
Studji in vitro juru li l- aċetat ta ’ caspofungin ma huwa inibitur tal- ebda enzima fis- sistema taċ - ċitokromu P450 (CYP).
In clinical studies, caspofungin did not induce the CYP3A4 metabolism of other substances.
Fi studji kliniċi, caspofungin ma induċiex il- metaboliżmu CYP3A4 ta ’ sustanzi oħra.
Caspofungin is not a substrate for P-glycoprotein and is a poor substrate for cytochrome P450 enzymes.
Caspofungin mhuwiex substrat għall- P- glikoproteina u huwa substrat fqir għall- enzimi taċ- ċitokromu P450.
However, caspofungin has been shown to interact with other medicinal products in pharmacological and clinical studies (see below).
Madankollu, caspofungin intwera li jinteraġixxi ma ’ prodotti mediċinali oħra fi studji farmakoloġiċi u kliniċi (ara taħt).
In two clinical studies performed in healthy adult subjects, cyclosporin A (one 4 mg/ kg dose or two 3 mg/ kg doses 12 hours apart) increased the AUC of caspofungin by approximately 35%.
F’ żewġ studji kliniċi li saru fuq individwi adulti b’ saħħithom, cyclosporin A (doża waħda ta ’ 4 mg/ kg jew żewġ dożi ta ’ 3 mg/ kg 12- il siegħa ’ l bogħod minn xulxin) żied l- AUC ta ’ caspofungin b’ madwar 35%.
These AUC increases are probably due to reduced uptake of caspofungin by the liver.
Dawn iż- żidiet fl- AUC huma probabbilment dovuti għal teħid imnaqqas ta ’ caspofungin mill - fwied.
CANCIDAS did not increase the plasma levels of cyclosporin.
CANCIDAS ma żiedx il- livelli fil- plażma ta ’ cyclosporin.
There were transient increases in liver ALT and AST of less than or equal to 3-fold the upper limit of normal (ULN) when CANCIDAS and cyclosporin were co-administered, that resolved with discontinuation of the medicinal products.
Kien hemm żidiet għaddiena fl- ALT u l- AST fil- fwied ta ’ inqas minn jew ugwali għal tliet darbiet il- limitu ta ’ fuq tan- normal (ULN) meta CANCIDAS u cyclosporin ingħataw flimkien, li marru bit- twaqqif tal- prodotti mediċinali.
In a retrospective study of 40 patients treated during marketed use with CANCIDAS and cyclosporin for 1 to 290 days (median 17.5 days), no serious hepatic adverse events were noted (see section 4.4).
Fi studju retrospettiv ta ’ 40 pazjent ittrattati waqt l- użu kummerċjalizzat b’ CANCIDAS u cyclosporin għal 1 sa 290 ġurnata (medjan 17. 5 ġranet), ma ġew innotati ebda episodji avversi serji fil- fwied (ara sezzjoni 4. 4).
Close monitoring of liver enzymes should be considered if the two medicinal products are used concomitantly.
Għandu jiġi kkunsidrat monitoraġġ mill- qrib tal- enzimi tal- fwied jekk iż- żewġ prodotti mediċinali jintużaw flimkien.
CANCIDAS reduced the trough concentration of tacrolimus by 26% in healthy adult volunteers.
CANCIDAS naqqas il- konċentrazzjoni ta ’ isfel ta ’ tacrolimus b’ 26% f’ voluntiera adulti b’ saħħithom.
For patients receiving both therapies, standard monitoring of tacrolimus blood concentrations and appropriate tacrolimus dosage adjustments are mandatory.
Fil- każ ta ’ pazjenti li jirċievu ż- żewġ terapiji, huma obbligatorji monitoraġġ standard tal - konċentrazzjonijiet ta ’ tacrolimus fid- demm u aġġustamenti xierqa fid- dożaġġ ta ’ tacrolimus.
4 rifampicin or mycophenolate mofetil.
4 Studji kliniċi fuq voluntiera adulti b’ saħħithom juru li l- farmakokinetiċi ta ’ CANCIDAS ma jinbidlux b’ mod klinikament sinifikanti b’ itraconazole, amphotericin B, mycophenolate, nelfinavir, jew tacrolimus.
Although safety data are limited it appears that no special precautions are needed when amphotericin B, itraconazole, nelfinavir or mycophenolate mofetil are co-administered with caspofungin.
Għalkemm l- informazzjoni dwar is- sigurtà hija limitata, jidher li m’ hemmx bżonn prekawzjonijiet speċjali meta amphotericin B, itraconazole, nelfinavir jew mycophenolate mofetil jingħataw fl- istess ħin ma ’ caspofungin.
Rifampicin caused a 60% increase in AUC and 170% increase in trough concentration of caspofungin on the first day of co-administration when both medicinal products were initiated together in healthy adult volunteers.
Rifampicin ikkaġuna żieda ta ’ 60% fl- AUC u żieda ta ’ 170% fl- inqas konċentrazzjoni ta ’ caspofungin fl- ewwel jum ta ’ għoti flimkien meta ż- żewġ prodotti mediċinali ġew mibdija flimkien f’ voluntiera adulti b’ saħħithom.
Caspofungin trough levels gradually decreased upon repeated administration.
L- inqas livelli ta ’ caspofungin naqsu b’ mod gradwali wara għoti ripetut.
After two weeks’ administration rifampicin had limited effect on AUC, but trough levels were 30% lower than in adult subjects who received caspofungin alone.
Wara ġimagħtejn għoti, rifampicin kellu effett limitat fuq l- AUC, iżda l- inqas livelli kienu 30% iżjed baxxi milli f’ individwi adulti li rċevew caspofungin waħdu.
The mechanism of interaction could possibly be due to an initial inhibition and subsequent induction of transport proteins.
Il- mekkaniżmu tal- interazzjoni jista ’ jkun dovut għal inibizzjoni inizjali u induzzjoni suċċessiva ta ’ enzimi tat- trasport.
A similar effect could be expected for other medicinal products that induce metabolic enzymes.
Jista ’ jkun mistenni effett simili għal prodotti mediċinali oħra li jinduċu l- enzimi metaboliċi.
Limited data from population pharmacokinetics studies indicate that concomitant use of CANCIDAS with the inducers efavirenz, nevirapine, rifampicin, dexamethasone, phenytoin, or carbamazepine may result in a decrease in caspofungin AUC.
Informazzjoni limitata minn studji farmakokinetiċi fuq il- popolazzjoni tindika li l- użu konkomitanti ta ’ CANCIDAS mal- indutturi efavirenz, nevirapine, rifampicin, dexamethasone, phenytoin, jew carbamazepine jista ’ jirriżulta fi tnaqqis fl- AUC ta ’ caspofungin.
When co-administering inducers of metabolic enzymes, an increase in the daily dose of CANCIDAS to 70 mg, following the 70 mg loading dose, should be considered in adult patients (see section 4.2).
Meta jingħataw fl- istess ħin indutturi tal- enzimi metaboliċi, għandha tiġi kkunsidrata żieda fid- doża ta ’ kuljum ta ’ CANCIDAS għal 70 mg fil- pazjenti adulti wara l- loading dose ta ’ 70 mg (ara sezzjoni 4. 2).
In paediatric patients, results from regression analyses of pharmacokinetic data suggest that co-administration of dexamethasone with CANCIDAS may result in clinically meaningful reductions in caspofungin trough concentrations.
F’ pazjenti pedjatriċi, ir- riżultati minn analiżijiet ta ’ rigressjoni ta ’ informazzjoni farmakokinetika jissuġġerixxu li l- għoti ta ’ dexamethasone ma ’ CANCIDAS jista ’ jirriżulta fi tnaqqis kliniku sinifikanti fl- inqas konċentrazzjonijiet ta ’ caspofungin.
This finding may indicate that paediatric patients will have similar reductions with inducers as seen in adults.
Din is- sejba tista ’ tindika li pazjenti pedjatriċi se jkollhom tnaqqis simili bl- indutturi kif jidher fl- adulti.
When CANCIDAS is co-administered to paediatric patients (12 months to 17 years of age) with inducers of drug clearance, such as rifampicin, efavirenz, nevirapine, phenytoin, dexamethasone, or carbamazepine, a CANCIDAS dose of 70-mg/ m2 daily (not to exceed an actual daily dose of 70 mg) should be considered.
Meta CANCIDAS jingħata lil pazjenti pedjatriċi (12- il xahar sa 17- il sena) fl- istess ħin ma ’ indutturi tat- tneħħija tal- mediċina, bħal rifampicin, efavirenz, nevirapine, phenytoin, dexamethasone, jew carbamazepine, għandha tiġi kkunsidrata doża ta ’ CANCIDAS ta ’ 70- mg/ m2 kuljum (li m’ għandhiex taqbeż doża attwali ta ’ 70 mg kuljum).
For CANCIDAS, no clinical data on exposed pregnancies are available.
Għal CANCIDAS, m’ hemmx tagħrif kliniku dwar l- użu waqt it- tqala.
Caspofungin should not be used during pregnancy unless clearly necessary.
Caspofungin m’ għandux jintuża waqt it- tqala jekk ma jkunx hemm bżonn ċar.
There are no adequate data from the use of caspofungin in pregnant women.
M’ hemmx informazzjoni adegwata mill- użu ta ’ caspofungin f’ nisa tqal.
Developmental studies in animals have shown adverse effects (see section 5.3).
Studji tal- iżvilupp fuq l- annimali wrew effetti ħżiena (ara sezzjoni 5. 3).
Caspofungin has been shown to cross the placental barrier in animal studies.
Caspofungin intwera li jgħaddi mill- barriera tal- plaċenta.
The potential risk to the human foetus is unknown.
Mhux magħruf ir- riskju li jista ’ jkun hemm għall- fetu uman.
Caspofungin is excreted in milk of lactating animals.
Caspofungin jitneħħa fil- ħalib ta ’ annimali jreddgħu.
It is not known whether it is excreted in human milk.
Mhux magħruf jekk jitneħħiex fil- ħalib uman.
Women receiving caspofungin should not breast-feed.
Nisa li jkunu qegħdin jirċievu caspofungin m’ għandhomx ireddgħu.
Adult patients In clinical studies, 1440 adult individuals received single or multiple doses of CANCIDAS:
Pazjenti adulti Fi studji kliniċi, 1440 individwu adult ingħataw dożi waħdiena jew multipli ta ’ CANCIDAS:
564 febrile neutropaenic patients (empirical therapy study), 125 patients with invasive candidiasis, 72 patients with invasive aspergillosis, 285 patients with localised Candida infections, and 394 individuals enrolled in Phase I studies.
564 pazjent newtropeniku bid- deni (studju ta ’ terapija empirika), 125 pazjent b’ kandidjasi invażiva, 72 pazjent b’ asperġillożi invażiva, 285 pazjent b’ infezzjonijiet Candida lokalizzati, u 394 individwu rreġistrati fi studji ta ’ Fażi I.
In the empirical therapy study patients had received chemotherapy for malignancy or had undergone hematopoietic stem-cell transplantation (including 39 allogeneic transplantations).
Fl- istudji tat- terapija empirika, il- pazjenti kienu rċevew kemjoterapija għal tumuri malinni jew kienu sottosposti għal trapjant ematopoetiku tal- istem- cells (fosthom 39 trapjant alloġeneiku).
In the studies involving patients with documented Candida infections, the majority of the patients with invasive Candida infections had serious underlying medical conditions (e. g., haematologic or other malignancy, recent major surgery, HIV) requiring multiple concomitant medications.
Fl- istudji li kienu jinvolvu pazjenti b’ infezzjonijiet Candida dokumentati, il - maġġoranza tal- pazjenti b’ infezzjonijiet Candida invażivi kellhom kundizzjonijiet mediċi sottostanti (eż. tumuri tad- demm jew oħrajn, operazzjoni maġġuri riċenti, HIV) li kienu jeħtieġu diversi medikazzjonijiet konkomitanti.
Patients in the non-comparative Aspergillus study often had serious predisposing medical conditions (e. g., bone marrow or peripheral stem cell transplants, haematologic malignancy, solid tumours or organ transplants) requiring multiple concomitant medications.
Il- pazjenti fl- istudju mhux komparattiv dwar l- Aspergillus sikwit kellhom kundizzjonijiet mediċi serji ta ’ predispożizzjoni (eż. trapjanti tal- mudullun jew tal- istem cells
Phlebitis was a commonly reported local injection-site adverse reaction in all patient populations.
5 periferali, tumuri ematoloġiċi, tumuri solidi jew trapjanti tal- organi) li kienu jeħtieġu diversi medikazzjonijiet konkomitanti.
Other local reactions included erythema, pain/ tenderness, itching, discharge, and a burning sensation.
Reazzjonijiet lokali oħra kienu jinkludu eritema, uġigħ/ irtubija, ħakk, tnixxija, u sensazzjoni ta ’ ħruq.
5 Reported clinical and laboratory abnormalities among all adult patients treated with CANCIDAS (total 989) were typically mild and rarely led to discontinuation.
L- anormalitajiet kliniċi u tal- laboratorju li ġew irrappurtati fost il- pazjenti adulti ttrattati b’ CANCIDAS (total 989) kienu ġeneralment ħfief u rari wasslu għal twaqqif tal- kura.
The following adverse reactions were reported:
Ġew irrappurtati r- reazzjonijiet avversi li ġejjin:
[Very common (≥ 1/ 10), Common (≥ 1/ 100, < 1/ 10)]
[Komuni ħafna (≥1/ 10), Komuni (≥1/ 100, < 1/ 10)]
Blood and lymphatic system disorders:
Disturbi tad- demm u tas- sistema limfatika:
Common: anaemia
Komuni: anemija
Common: headache
Komuni: uġigħ ta ’ ras
Common: tachycardia
Komuni: takikardija
Common: phlebitis/ thrombophlebitis, flushing
Komuni: flebite/ tromboflebite, fwawar
Common: dyspnoea
Komuni: dispneja
Common: abdominal pain, nausea, diarrhoea, vomiting
Komuni: uġigħ addominali, dardir, dijarea, rimettar
Common: rash, pruritus, sweating
Komuni: raxx, ħakk, għaraq
General disorders and administration site conditions:
Disturbi ġenerali u kundizzjonijiet ta ’ mnejn jingħata:
Very common: fever Common: pain, chills, infused-vein complications
Komuni ħafna: deni Komuni: uġigħ, tertir, kumplikazzjonijiet fil- vina infuża
Common: elevated liver values (AST, ALT, alkaline phosphatase, direct and total bilirubin), increased serum creatinine, decreased haemoglobin, decreased haematocrit, blood potassium decreased, hypomagnesaemia, low albumin, decreased white blood cells, increased eosinophils, platelet count decreased, decreased neutrophils, increased urinary red blood cells, increased partial thromboplastin time, decreased total serum protein, increased urinary protein, increased prothrombin time, blood sodium decreased, increased urinary white blood cells and low calcium.
Komuni: żidiet fil- valuri tal- fwied (AST, ALT, alkaline phosphatase, bilirubina diretta u totali), żieda ta ’ kreatinina fis- serum, tnaqqis fl- emoglobina, tnaqqis fl- ematokrit, tnaqqis ta ’ potassju fid- demm, ipomanjesimja, albumina baxxa, tnaqqis fiċ- ċelloli bojod tad- demm, żieda fl- esonifili, tnaqqis fl- għadd tal- plejtlits, tnaqqis fin- newtrofili, żieda fiċ- ċelloli ħomor tad- demm fl- awrina, żieda fil- ħin parzjali tat- thromboplastin, tnaqqis fil- proteina totali fis- serum, żieda fil- proteina fl- awrina, żieda fil- ħin għall - koagulazzjoni tad- demm, tnaqqis ta ’ sodju fid- demm, żieda fiċ- ċelloli bojod tad- demm fl- awrina u livell baxx ta ’ kalċju.
High calcium has been reported as uncommon (≥ 1/ 1000, < 1/ 100).
Livell għoli ta ’ kalċju ġie rrappurtat bħala mhux komuni (≥1/ 1000, < 1/ 100).
Possible histamine-mediated symptoms have been reported including reports of rash, facial swelling, pruritus, sensation of warmth, or bronchospasm.
Ġew irrappurtati sintomi li jistgħu jkunu medjati mill- istamina fosthom rapporti ta ’ raxx, nefħa fil - wiċċ, ħakk, sensazzjoni ta ’ sħana, jew bronkospażmu.
Anaphylaxis has been reported during administration of CANCIDAS.
Kienet irrappurtata anafilassi waqt l- għoti ta ’ CANCIDAS.
Also reported in patients with invasive aspergillosis were pulmonary oedema, adult respiratory distress syndrome (ARDS), and radiographic infiltrates.
F’ pazjenti b’ asperġillożi invażiva kienu rrappurtati wkoll edema pulmonari, is- sindrome tad- diqa respiratorja fl- adulti (ARDS – adult respiratory distress syndrome), u infiltrate radjografiċi.
Paediatric Patients In clinical studies, 171 paediatric patients received single or multiple doses of CANCIDAS:
Pazjenti pedjatriċi Fi studji kliniċi, 171 pazjent pedjatriku rċevew dożi waħdiena jew multipli ta ’ CANCIDAS:
104 febrile, neutropenic patients; 56 patients with invasive candidiasis; 1 patient with esophageal candidiasis; and 10 patients with invasive aspergillosis.
104 pazjenti b’ newtropenija febbrili; 56 pazjent b’ kandidjasi invażiva; pazjent wieħed b’ kandidjasi
The overall safety profile of CANCIDAS in paediatric patients is generally comparable to that in adult patients.
Il- profil ġenerali tas- sigurtà ta ’ CANCIDAS f’ pazjenti pedjatriċi huwa ġeneralment komparabbli ma ’ dak fil- pazjenti adulti.
The following adverse reactions were reported:
Ġew irrappurtati dawn ir- reazzjonijiet avversi:
6 [Very common (≥ 1/ 10), Common (≥ 1/ 100, < 1/ 10)]
[Komuni ħafna (≥1/ 10), Komuni (≥1/ 100, < 1/ 10)]
Common: flushing, hypotension
Komuni: fwawar, pressjoni baxxa
Hepatobiliary disorders:
Disturbi fil- fwied u fil- marrara:
Elevated liver enzyme levels (AST, ALT)
Żieda fil- livelli tal- enzimi fil- fwied (AST, ALT)
Common: rash, pruritus
Komuni: raxx, ħakk
Very Common: fever Common: chills, catheter site pain
Komuni ħafna: deni Komuni: tertir, uġigħ fis- sit tal- kateter
Common: decreased potassium, hypomagnesemia, increased glucose, decreased phosphorus, increased phosphorus, and increased eosinophils.
Komuni: tnaqqis fil- potassju, ipomanjesimja, żieda fil- glukożju, tnaqqis fil- fosfru, żieda fil- fosfru, u żieda fl- esinofili.
As in adult patients, similar histamine-mediated symptoms have also been reported in paediatric patients.
L- istess bħal fil- pazjenti adulti, sintomi simili medjati mill- istamina ġew irrappurtati wkoll f’ pazjenti pedjatriċi.
Post-Marketing experience:
Esperjenza ta ’ wara t- tqegħid fis- suq:
The following post-marketing adverse events have been reported:
Ġew irrappurtati dawn l- episodji avversi ta ’ wara t- tqegħid fis- suq:
Hepatic dysfunction
Disfunzjoni tal- fwied
Swelling and peripheral oedema
Nefħa u edema periferali
Hypercalcaemia
Iperkalċimija
Inadvertent administration of up to 140 mg of caspofungin in one day has been reported.
Kien hemm rapporti ta ’ għoti aċċidentali ta ’ dożi sa 140 mg ta ’ caspofungin f’ ġurnata waħda.
These occurrences did not result in clinically important adverse experiences.
Dawn l - inċidenzi ma rriżultawx f’ esperjenzi avversi klinikament sinfikanti.
Caspofungin is not dialysable.
Caspofungin mhuwiex dijalizzabbli.
Pharmacotherapeutic group: antimycotics for systemic use, ATC Code:
Kategorija farmakoterapewtika: antimikotiċi għall- użu sistemiku, Kodiċi ATC:
Caspofungin acetate is a semi-synthetic lipopeptide (echinocandin) compound synthesised from a fermentation product of Glarea lozoyensis.
L- aċetat ta ’ caspofungin huwa kompost ta ’ lipopeptide (echinocandin) semisintetiku sintetizzat minn prodott ta ’ fermentazzjoni ta ’ Glarea lozoyensis.
Caspofungin acetate inhibits the synthesis of beta (1,3)-D-glucan, an essential component of the cell wall of many filamentous fungi and yeast.
L- aċetat ta ’ caspofungin jimpedixxi s- sinteżi ta ’ beta (1, 3) - D- glucan, komponent essenzjali tal- ħajt taċ- ċelloli ta ’ ħafna fungi u ħmira li fihom fibri qishom ħjut.
Beta (1,3)-D-glucan is not present in mammalian cells.
Beta (1, 3) - D- glucan mhuwiex preżenti fiċ- ċelloli mammiferi.
7 Fungicidal activity with caspofungin has been demonstrated against Candida yeasts.
L- attività fungiċida b’ caspofungin ġiet murija kontra ħmejjer Candida.
Studies in vitro and in vivo demonstrate that exposure of Aspergillus to caspofungin results in lysis and death of hyphal apical tips and branch points where cell growth and division occur.
Studji in vitro u in vivo juru li l- esponiment tal- Aspergillus għal caspofungin jirriżulta f’ lisi u mewt tal- ponot apikali tal- filamenti fil - miċelju ta ’ fungu u tal- fergħat fejn iseħħu t- tkabir u l- qsim taċ- ċelloli.
Caspofungin has in vitro activity against Aspergillus species (Aspergillus fumigatus [N = 75], Aspergillus flavus [N = 111], Aspergillus niger [N = 31], Aspergillus nidulans [N = 8], Aspergillus terreus [N = 52], and Aspergillus candidus [N = 3]).
Caspofungin għandu attività in vitro kontra l- ispeċijiet Aspergillus (Aspergillus fumigatus [N = 75], Aspergillus flavus [N = 111], Aspergillus niger [N = 31], Aspergillus nidulans [N = 8], Aspergillus terreus [N = 52], u Aspergillus candidus [N = 3]).
Caspofungin also has in vitro activity against Candida species (Candida albicans [N = 1032], Candida dubliniensis [N = 100], Candida glabrata [N = 151], Candida guilliermondii [N = 67], Candida kefyr [N = 62], Candida krusei [N = 147], Candida lipolytica [N = 20], Candida lusitaniae [N = 80], Candida parapsilosis [N = 215], Candida rugosa [N = 1], and Candida tropicalis [N = 258]), including isolates with multiple resistance transport mutations and those with acquired or intrinsic resistance to fluconazole, amphotericin B, and 5-flucytosine.
Caspofungin għandu wkoll attività in vitro kontra l - ispeċijiet Candida (Candida albicans [N = 1032], Candida dubliniensis [N = 100], Candida glabrata [N = 151], Candida guilliermondii [N = 67], Candida kefyr [N = 62], Candida krusei [N = 147], Candida lipolytica [N = 20], Candida lusitaniae [N = 80], Candida parapsilosis [N = 215], Candida rugosa [N = 1], u Candida tropicalis [N = 258]), fosthom iżolati b’ multiple resistance transport mutations u dawk b’ reżistenza akkwiżita jew intrinsika għal fluconazole, amphotericin B, u 5 - flucytosine.
Susceptibility testing was performed according to a modification of both the Clinical and Laboratory Standards Institute (CLSI, formerly known as the National Committee for Clinical Laboratory Standards [NCCLS]) method M38-A (for Aspergillus species) and method M27-A (for Candida species).
L- ittestjar tas- suxxettibilità sar skont modifika kemm tal- metodu M38- A (għall- ispeċijiet Aspergillus) tal- Istitut għall- Istandards Kliniċi u tal- Laboratorju (CLSI, li qabel kien magħruf bħala l - Kumitat Nazzjonali għall- Istandards tal- Laboratorji Kliniċi [NCCLS]) kif ukoll tal- metodu M27- A (għall- ispeċijiet Candida).
Mutants of Candida with reduced susceptibility to caspofungin have been identified in some patients during treatment.
Mutanti ta ’ Candida b’ suxxettibilità mnaqqsa għal caspofungin ġew identifikati f’ xi pazjenti waqt it- trattament.
However, standardised techniques for susceptibility testing for antifungal agents, including beta (1,3)-D-glucan synthesis inhibitors, have not been established.
Madankollu, ma kinux stabbiliti metodi standardizzati għall- ittestjar tas- suxxettibilità għal sustanzi antifungali, inklużi inibituri tas- sintesi ta ’ beta (1, 3) - D- glucan.
MIC values for caspofungin should not be used to predict clinical outcome, since a correlation between MIC values and clinical outcome has not been established.
Il- valuri MIC għal caspofungin m’ għandhomx jintużaw biex jiġi mbassar l- eżitu kliniku, minħabba li ma ġietx stabbilita korrelazzjoni bejn il- valuri MIC u l- eżitu kliniku.
Development of in vitro resistance to caspofungin by Aspergillus species has not been identified.
Ma ġiex identifikat żvilupp ta ’ reżistenza in vitro għal caspofungin mill- ispeċijiet Aspergillus.
In limited clinical experience, resistance to caspofungin in patients with invasive aspergillosis has not been observed.
F’ esperjenza klinika limitata, ma ġietx osservata reżistenza għal caspofungin f’ pazjenti b’ asperġillożi invażiva.
The incidence of resistance to caspofungin by various clinical isolates of Candida and Aspergillus is unknown.
L - inċidenza tar- reżistenza għal caspofungin mid- diversi iżolati kliniċi ta ’ Candida u Aspergillus mhijiex magħrufa.
Invasive Candidiasis in Adult Patients:
Kandidjasi Invażiva f’ Pazjenti Adulti:
Two hundred thirty-nine patients were enrolled in a study to compare caspofungin and amphotericin B for the treatment of invasive candidiasis.
Mitejn u disgħa u tletin pazjent ġew irreġistrati fi studju li qabbel caspofungin ma ’ amphotericin B għat- trattament ta ’ kandidjasi invażiva.
Twenty-four patients had neutropaenia.
Erbgħa u għoxrin pazjent kellhom newtropenija.
The most frequent diagnoses were bloodstream infections (candidaemia) (77%, n=186) and Candida peritonitis (8%, n=19); patients with Candida endocarditis, osteomyelitis, or meningitis were excluded from this study.
L- aktar sejbiet frekwenti kienu infezzjonijiet fin- nixxiegħa tad- demm (candidaemia) (77%, n=186) u peritonite Candida (8%, n=19); pazjenti b’ endokardite, osteomjelite, jew meninġite Candida kienu esklużi minn dan l- istudju.
Caspofungin 50 mg once daily was administered following a 70 mg loading dose, while amphotericin B was administered at 0.6 to 0.7 mg/ kg/ day to non-neutropaenic patients or 0.7 to 1.0 mg/ kg/ day to neutropaenic patients.
Caspofungin 50 mg darba kuljum ingħata wara loading dose ta ’ 70 mg, filwaqt li amphotericin B ingħata f’ doża ta ’ 0. 6 sa 0. 7 mg/ kg/ kuljum lil pazjenti mhux newtropeniċi jew 0. 7 sa 1. 0 mg/ kg/ kuljum lil pazjenti newtropeniċi.
The mean duration of intravenous therapy was 11.9 days, with a range of 1 to 28 days.
It- tul medju tat - terapija fil- vini kien ta ’ 11. 9 ġranet, b’ medda ta ’ 1 sa 28 ġurnata.
A favourable response required both symptom resolution and microbiological clearance of the Candida infection.
Rispons favorevoli kien jeħtieġ kemm għibien tas- sintomi kif ukoll tneħħija mikrobijoloġika tal- infezzjoni Candida.
Two hundred twenty-four patients were included in the primary efficacy analysis (MITT analysis) of response at the end of IV study therapy; favourable response rates for the treatment of invasive candidiasis were comparable for caspofungin (73% [80/ 109]) and amphotericin B (62% [71/ 115]) [% difference 12.7 (95.6% CI -0.7, 26.0)].
Mitejn u erbgħa u għoxrin pazjent kienu inklużi fl- analiżi primarja tal- effikaċja (analiżi MITT) tar- rispons fit- tmiem tat - terapija ta ’ studju fil- vini; ir- rati ta ’ rispons favorevoli għat- trattament ta ’ kandidjasi invażiva kienu komparabbli għal caspofungin (73% [80/ 109]) u amphotericin B (62% [71/ 115]) [% differenza 12. 7 (95. 6% CI - 0. 7, 26. 0)].
Among patients with candidaemia, favourable response rates at the end of IV study therapy were comparable for caspofungin (72% [66/ 92]) and amphotericin B (63% [59/ 94]) in the primary efficacy analysis (MITT analysis) [% difference 10.0 (95.0% CI -4.5, 24.5)].
Fost il- pazjenti b’ candidaemia, ir- rati ta ’ rispons favorevoli fit- tmiem tat - terapija ta ’ studju fil- vini kienu komparabbli għal caspofungin (72% [66/ 92]) u amphotericin B (63% [59/ 94]) fl- analiżi primarja tal- effikaċja (MITT analysis) [% difference 10. 0 (95. 0% CI - 4. 5, 24. 5)].
Data in patients with non-blood sites of infection were more limited.
L- informazzjoni minn pazjenti b’ siti ta ’ infezzjoni mhux fid- demm kienet iżjed limitata.
Favourable response rates in neutropaenic patients were 7/ 14 (50%) in the caspofungin group and 4/ 10 (40%) in the amphotericin B group.
Ir- rati ta ’ rispons favorevoli f’ pazjenti newtropeniċi kienu 7/ 14 (50%) fil- grupp ta ’ caspofungin u 4/ 10 (40%) fil- grupp ta ’ amphotericin B.
These limited data are supported by the outcome of the empirical therapy study.
Din l- informazzjoni limitata hija appoġġata mill- eżitu tal- istudju dwar it - terapija empirika.
Invasive Aspergillosis in Adult Patients:
8 Asperġillożi Invażiva f’ Pazjenti Adulti:
Sixty-nine adult patients (age 18-80) with invasive aspergillosis were enrolled in an open-label, non-comparative study to evaluate the safety, tolerability, and efficacy of caspofungin.
Disgħa u sittin pazjent adult (18- 80 sena) b’ asperġillożi invażiva ġew irreġistrati fi studju open- label, mhux komparattiv biex jiġu evalwati s- sigurtà, it - tollerabilità u l- effikaċja ta ’ caspofungin.
Patients had to be either refractory to (disease progression or failure to improve with other antifungal therapies given for at least 7 days) (84% of the enrolled patients) or intolerant of (16% of enrolled patients) other standard antifungal therapies.
Il- pazjenti riedu jkunu jew refrattorji għal (progressjoni tal - marda jew nuqqas ta ’ titjib b’ terapiji antifungali oħra mogħtija għal mill- anqas 7 ijiem) (84% tal - pazjenti rreġistrati) jew intolleranti (16% tal- pazjenti rreġistrati) għal terapiji antifungali oħra standard.
Most patients had underlying conditions (haematologic malignancy [N = 24], allogeneic bone marrow transplant or stem cell transplant [N = 18], organ transplant [N = 8], solid tumour [N = 3], or other conditions [N = 10]).
Il- biċċa l- kbira tal- pazjenti kellhom kundizzjonijiet sottostanti (tumuri ematoloġiċi [N = 24], trapjant alloġeneiku tal- mudullun jew trapjant ta ’ stem cells [N = 18], trapjant ta ’ organi [N = 8], tumur solidu [N = 3], jew kundizzjonijiet oħra [N = 10]).
Stringent definitions, modelled after the Mycoses Study Group Criteria, were used for diagnosis of invasive aspergillosis and for response to therapy (favourable response required clinically significant improvement in radiographs as well as in signs and symptoms).
Intużaw definizzjonijiet strinġenti, immudellati wara l- Kriterji tal- Grupp ta ’ Studju dwar il- Mikożi, għad- dijanjosi tal- asperġillożi invażiva u għar- rispons għat- terapija (rispons favorevoli kien jeħtieġ kemm titjib kliniku sinifikanti fir- radjografs kif ukoll fis- sinjali u s- sintomi).
The mean duration of therapy was 33.7 days, with a range of 1 to 162 days.
It- terapija damet medja ta ’ 33. 7 ġranet, b’ medda ta ’ 1 sa 162 ġurnata.
An independent expert panel determined that 41% (26/ 63) of patients receiving at least one dose of caspofungin had a favourable response.
Panel ta ’ esperti indipendenti stabbilixxa li 41% (26/ 63) tal- pazjenti li rċevew mill- anqas doża waħda ta ’ caspofungin kellhom rispons favorevoli.
For those patients who received more than 7 days of therapy with caspofungin, 50% (26/ 52) had a favourable response.
Fil- każ ta ’ dawk il- pazjenti li rċevew iżjed minn 7 ijiem ta ’ terapija b’ caspofungin, 50% (26/ 52) kellhom rispons favorevoli.
8 were 36% (19/ 53) and 70% (7/ 10), respectively.
Ir- rati ta ’ rispons favorevoli għall- pazjenti li kienu jew refrattorji jew intolleranti għal terapiji preċedenti kienu 36% (19/ 53) u 70% (7/ 10), rispettivament.
Although the doses of prior antifungal therapies in 5 patients enrolled as refractory were lower than those often administered for invasive aspergillosis, the favourable response rate during therapy with caspofungin was similar in these patients to that seen in the remaining refractory patients (2/ 5 versus 17/ 48, respectively).
Għalkemm id- dożi tat- terapiji antifungali preċedenti f’ 5 pazjenti rreġistrati bħala refrattorji kienu iżjed baxxi minn dawk li sikwit jingħataw għal asperġillożi invażiva, ir- rata ta ’ rispons favorevoli matul it- terapija b’ caspofungin f’ dawn il- pazjenti kienet simili għal dik li dehret fil- bqija tal- pazjenti refrattorji (2/ 5 kontra 17/ 48, rispettivament).
The response rates among patients with pulmonary disease and extrapulmonary disease were 47% (21/ 45) and 28% (5/ 18), respectively.
Ir- rati ta ’ rispons fost pazjenti b’ mard pulmonari u mard ekstrapulmonari kienu 47% (21/ 45) u 28% (5/ 18), rispettivament.
Among patients with extrapulmonary disease, 2 of 8 patients who also had definite, probable, or possible CNS involvement had a favourable response.
Fost il - pazjenti b’ mard ekstrapulmonari, 2 minn 8 pazjenti li kellhom ukoll involviment definittiv, probabbli, jew possibbli tal- CNS kellhom rispons favorevoli.
Empirical Therapy in Febrile, Neutropaenic Adult Patients:
Terapija Empirika f’ Pazjenti Newtropeniċi Febbrili Adulti:
A total of 1111 patients with persistent fever and neutropaenia were enrolled in a clinical study and treated with either caspofungin 50 mg once daily following a 70 mg loading dose or liposomal amphotericin B 3.0 mg/ kg/ day.
Total ta ’ 1111- il pazjent b’ deni persisteni u newtropenija ġew irreġistrati fi studju kliniku u ttrattati b’ caspofungin 50 mg darba kuljum wara loading dose ta ’ 70 mg jew b’ amphotericin B liposomali 3. 0 mg/ kg/ kuljum.
Eligible patients had received chemotherapy for malignancy or had undergone hematopoietic stem-cell transplantation, and presented with neutropaenia (< 500 cells/mm3 for 96 hours) and fever (> 38.0°C) not responding to ≥ 96 hours of parenteral antibacterial therapy.
Il- pazjenti eliġibbli kienu rċevew kemjoterapija għal tumuri jew kienu sottoposti għal trapjant ematopoetiku tal- istem cells, u ppreżentaw newtropenija (< 500 ċellola/ mm3 għal 96 siegħa) u deni (> 38. 0°C) li ma rrispondewx għal ≥96 siegħa ta ’ terapija antibatterika parenterali.
Patients were to be treated until up to 72 hours after resolution of neutropaenia, with a maximum duration of 28 days.
Il- pazjenti kellhom jiġu kkurati sa 72 siegħa wara li titlaq in- newtropenija, b’ dewmien massimu ta ’ 28 ġurnata.
However, patients found to have a documented fungal infection could be treated longer.
Madankollu, pazjenti misjuba li għandhom infezzjoni fungali dokumentata setgħu jiġu ttrattati għal perjodu itwal.
If the drug was well tolerated but the patient’ s fever persisted and clinical condition deteriorated after 5 days of therapy, the dosage of study drug could be increased to 70 mg/ day of caspofungin (13.3% of patients treated) or to 5.0 mg/ kg/ day of liposomal amphotericin B (14.3% of patients treated).
Jekk il- mediċina kienet ittollerata sewwa iżda d- deni tal- pazjent ippersista u l- kundizzjoni klinika ddeterjorat wara 5 ijiem ta ’ terapija, id- doża tal- mediċina tal- istudju setgħet tiżdied għal 70 mg/ kuljum ta ’ caspofungin (13. 3% tal - pazjenti ttrattati) jew għal 5. 0 mg/ kg/ kuljum ta ’ amphotericin B liposomali (14. 3% tal- pazjenti ttrattati).
There were 1095 patients included in the primary Modified Intention-To-Treat (MITT) efficacy analysis of overall favourable response; caspofungin (33.9%) was as effective as liposomal amphotericin B (33.7%) [% difference 0.2 (95.2% CI – 5.6, 6.0)].
Kien hemm 1095 pazjent inklużi fl- analiżi primarja tal- effikaċja Modified Intention- To- Treat (MITT) tar- rispons favorevoli globali; caspofungin (33. 9%) kien effettiv daqs amphotericin B liposomali (33. 7%) [% differenza 0. 2 (95. 2% CI – 5. 6, 6. 0)].
An overall favourable response required meeting each of 5 criteria:
Rispons favorevoli globali kien jeħtieġ li jiġu sodisfatti kull wieħed minn 5 kriterji:
(1) successful treatment of any baseline fungal infection (caspofungin 51.9% [14/ 27], liposomal amphotericin B 25.9% [7/ 27]), (2) no breakthrough fungal infections during administration of study drug or within 7 days after completion of treatment (caspofungin 94.8% [527/ 556], liposomal amphotericin B 95.5% [515/ 539]), (3) survival for 7 days after completion of study therapy (caspofungin 92.6% [515/ 556], liposomal amphotericin B 89.2% [481/ 539]), (4) no discontinuation from the study drug because of drug-related toxicity or lack of efficacy (caspofungin 89.7% [499/ 556], liposomal amphotericin B 85.5% [461/ 539]), and (5) resolution of fever during the period of neutropaenia (caspofungin 41.2% [229/ 556], liposomal amphotericin B 41.4% [223/ 539]).
(1) trattament b’ suċċess ta ’ kwalunkwe infezzjoni fungali fil- linja bażi (caspofungin 51. 9% [14/ 27], amphotericin B liposomali 25. 9% [7/ 27]), (2) ebda infezzjonijiet fungali ġodda waqt l- għoti tal- mediċina tal- istudju jew sa 7 ijiem wara t- tlestija tat - trattament (caspofungin 94. 8% [527/ 556], amphotericin B liposomali 95. 5% [515/ 539]), (3) sopravivenza għal 7 ijiem wara t- tlestija tat- terapija tal- istudju (caspofungin 92. 6% [515/ 556], amphotericin B liposomali 89. 2% [481/ 539]), (4) ebda twaqqif mill- mediċina tal- istudju minħabba effett tossiku relatat mal- mediċina jew nuqqas ta ’ effikaċja (caspofungin 89. 7% [499/ 556], amphotericin B liposomali 85. 5% [461/ 539]), u (5) tluq tad- deni matul il- perjodu ta ’ newtropenija (caspofungin 41. 2% [229/ 556], amphotericin B liposomali 41. 4% [223/ 539]).
Response rates to caspofungin and liposomal amphotericin B for baseline infections caused by Aspergillus species were, respectively, 41.7% (5/ 12) and 8.3% (1/ 12), and by Candida species were 66.7% (8/ 12) and 41.7% (5/ 12).
Ir- rati ta ’ rispons għal caspofungin u amphotericin B liposomali għall- infezzjonijiet tal- linja bażi kkawżati mill- ispeċijiet Aspergillus kienu, rispettivament, 41. 7% (5/ 12) u 8. 3% (1/ 12), u mill- ispeċijiet Candida kienu 66. 7% (8/ 12) and 41. 7% (5/ 12).
Trichosporon species (1), Fusarium species (1), Mucor species (1), and Rhizopus species (1).
Pazjenti fil- grupp ta ’ caspofungin esperjenzaw infezzjonijiet ġodda minħabba dawn il- ħmejjer u mofof mhux komuni: speċi Trichosporon (1), speċi Fusarium (1), speċi Mucor (1), u speċi Rhizopus (1).
Paediatric Patients The safety and efficacy of CANCIDAS was evaluated in paediatric patients 3 months to 17 years of age in two prospective, multicenter clinical trials.
Pazjenti pedjatriċi Is- sigurtà u l- effikaċja ta ’ CANCIDAS ġiet evalwata f’ pazjenti pedjatriċi minn 3 xhur sa 17- il sena f’ żewġ provi kliniċi prospettivi multiċentri.
The study design, diagnostic criteria, and criteria for efficacy assessment were similar to the corresponding studies in adult patients (see section 5.1).
Id- disinn tal- istudju, il- kriterji dijanjostiċi, u l- kriterji għall- valutazzjoni tal- effikaċja kienu simili għall- istudji korrispondenti f’ pazjenti adulti (ara sezzjoni 5. 1).