FrancophonIA/ELRC3.0 huggingface dataset:
English: Moderate (creatinine clearance 31 to 49 mL/min), advanced (creatinine clearance 5 to 30 mL/min), and end-stage (creatinine clearance <10 mL/min and dialysis dependent) renal impairment moderately increased caspofungin plasma concentrations after single-dose administration (range: 30 to 49 % for AUC).
Maltese: Indeboliment renali moderat (tneħħija tal-kreatinina ta' 31 sa 49 mL/min), avanzat (tneħħija tal-kreatinina ta' 5 sa 30 mL/min), u tal-aħħar stadju (tneħħija talkreatinina ta' <10 mL/min u dipendenti fuq id-dijalisi) żied moderatament il-konċentrazzjonijiet ta' caspofungin fil-plażma wara l-għoti ta' doża waħda (medda: 30 sa 49 % għall-AUC).
English: • Inflammation of the vein
Maltese: • Infjammazzjoni tal-vina
English: Succinic acid
Maltese: Sucrose Mannitol Succinic acid
English: In patients weighing more than 80 kg, after the initial 70 mg loading dose, caspofungin 70 mg daily is recommended (see section 5.2).
Maltese: F'pazjenti li jiżnu aktar minn 80 kg, wara l-loading dose inizjali ta' 70 mg, huwa rakkomandat caspofungin 70 mg kuljum (ara sezzjoni 5.2).
English: In a multiple-dose study, a dose reduction of the daily dose to 35 mg in adult patients with moderate hepatic impairment has been shown to provide an AUC similar to that obtained in adult subjects with normal hepatic function receiving the standard regimen (see section 4.2).
Maltese: Fi studju ta' dożi multipli, tnaqqis fid-doża għal 35 mg kuljum f'pazjenti adulti b'indeboliment moderat tal-fwied intwera li jipprovdi AUC simili għal dik miksuba f'suġġetti adulti b'funzjoni tal-fwied normali li kienu qegħdin jirċievu t-terapija standard (ara sezzjoni 4.2).
English: 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.
Maltese: 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.
English: The distribution into tissues peaked at 1.5 to 2 days after dosing when 92 % of the dose was distributed into tissues.
Maltese: Id-distribuzzjoni fit-tessuti laħqet l-ogħla livell ma' 1.5 sa 2 ġranet wara l-għoti tad-doża meta 92% tad-doża kien distribwit fittessuti.
English: In clinical studies, caspofungin did not induce or inhibit the CYP3A4 metabolism of other medicinal products.
Maltese: Fi studji kliniċi, caspofungin ma kkawżax jew impedixxa l-metaboliżmu CYP3A4 ta' prodotti mediċinali oħra.
English: Overall, the available pharmacokinetic, efficacy, and safety data are limited in patients 3 to 10 months of age.
Maltese: B'mod ġenerali, l-informazzjoni disponibbli dwar il-farmakokinetika, l-effikaċja u s-sigurtà hija limitata f'pazjenti ta' bejn 3 u 10 xhur.
English: 564 febrile neutropaenic patients (empirical therapy study), 382 patients with invasive candidiasis, 228 patients with invasive aspergillosis, 297 patients with localised Candida infections, and 394 individuals enrolled in Phase I studies.
Maltese: Fi studji kliniċi, 1,865 individwu adult ingħataw dożi waħdiena jew multipli ta' caspofungin: 564 pazjent newtropeniku bid-deni (studju ta' terapija empirika), 382 pazjent b'kandidjasi invażiva, 228 pazjent b'asperġillożi invażiva, 297 pazjent b'infezzjonijiet Candida lokalizzati, u 394 individwu rreġistrati fi studji ta' Fażi I.
English: Renal impairment: In a clinical study of single 70 mg doses, caspofungin pharmacokinetics were similar in adult volunteers with mild renal impairment (creatinine clearance 50 to 80 mL/min) and control subjects.
Maltese: Fi studju kliniku ta' dożi waħdiena ta' 70 mg, il-farmakokinetiċi ta' caspofungin kienu simili fil-voluntiera adulti b'indeboliment renali ħafif (tneħħija tal-kreatinina ta' 50 sa 80 mL/min) u s-suġġetti ta' kontroll.
English: Reported clinical and laboratory abnormalities among all adults treated with caspofungin (total 1,780) were typically mild and rarely led to discontinuation.
Maltese: L-anormalitajiet kliniċi u tal-laboratorju li ġew irrappurtati fost l-adulti ttrattati b'caspofungin (total 1,780) kienu ġeneralment ħfief u rari wasslu għal twaqqif tal-kura.
English: 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.
Maltese: 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.
English: Mechanism of action
Maltese: • darba kuljum
English: In clinical studies, caspofungin did not induce the CYP3A4 metabolism of other substances.
Maltese: Fi studji kliniċi, caspofungin ma induċiex il-metaboliżmu CYP3A4 ta' sustanzi oħra.
English: Other medicines and Caspofungin Accord
Maltese: Mediċini oħra u Caspofungin Accord
English: Fungicidal activity with caspofungin has been demonstrated against Candida yeasts.
Maltese: L-attività fungiċida b'caspofungin ġiet murija kontra ħmejjer Candida.
English: Skin and subcutaneous tissue disorders rash, pruritus, erythema, hyperhidrosis erythema multiforme, rash macular, rash maculo-papular, rash pruritic, urticaria, dermatitis allergic, pruritus generalised, rash erythematous, rash generalised, rash morbilliform, skin lesion
Maltese: Disturbi fil-ġilda u fittessuti ta' taħt il-ġilda raxx, ħakk, eritema, iperidrożi eritema multiforme, raxx makulari, raxx makulo-papulari, raxx bil-ħakk, urtikarja, dermatite allerġika, ħakk ġeneralizzat, raxx eritematuż, raxx ġeneralizzat, raxx morbilliforme, leżjoni fil-ġilda
English: A short alpha-phase occurs immediately post-infusion, followed by a beta-phase with a halflife of 9 to 11 hours.
Maltese: Fażi alpha qasira sseħħ immedjatament wara l-infużjoni, segwita minn fażi beta b'half-life ta' 9 sa 11-il siegħa.
English: Invasive Aspergillosis in Adult Patients: 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.
Maltese: Disgħa u sittin pazjent adult (18-80 sena) b'asperġillożi invażiva ġew irreġistrati fi studju open-label, mhux komparattiv biex jiġu evalwati s-sigurtà, ittollerabilità u l-effikaċja ta' caspofungin.
English: 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)].
Maltese: Fost il-pazjenti b'candidaemia, ir-rati ta' rispons favorevoli fit-tmiem tatterapija ta' studju fil-vini kienu komparabbli għal caspofungin (72 % [66/92]) u amphotericin B (63 % [59/94]) fl-analiżi primarja tal-effikaċja (analiżi MITT) [% differenza 10.
English: Therapy should be continued until up to 72 hours after resolution of neutropaenia (ANC≥500).
Maltese: It-terapija għandha tissokta sa 72 siegħa wara s-solvien tan-newtropenija (ANC≥500).
English: The favourable overall response rates at the end of caspofungin therapy were similar in the 2 treatment groups: 72 % (73/102) and 78 % (74/95) for the caspofungin 50-mg and 150-mg treatment groups, respectively (difference 6.3 % [95 % CI -5.9, 18.4]).
Maltese: 72 % (73/102) u 78 % (74/95) għallgruppi ta' kura ta' caspofungin 50 mg u 150 mg, rispettivament (differenza 6.3 % [95 % CI -5.9,
English: Limited data from population pharmacokinetics studies indicate that concomitant use of caspofungin with the inducers efavirenz, nevirapine, rifampicin, dexamethasone, phenytoin, or carbamazepine may result in a decrease in caspofungin AUC.
Maltese: Informazzjoni limitata minn studji farmakokinetiċi fuq il-popolazzjoni tindika li l-użu konkomitanti ta' caspofungin mal-indutturi efavirenz, nevirapine, rifampicin, dexamethasone, phenytoin, jew carbamazepine jista' jirriżulta fi tnaqqis fl-AUC ta' caspofungin.
English: However, available data suggest that caspofungin continues to be well tolerated with longer courses of therapy (up to 162 days in adult patients and up to 87 days in paediatric patients).
Maltese: Madankollu, dejta disponibbli tissuġġerixxi li caspofungin ikompli jkun ittollerat tajjeb b'korsijiet itwal ta' terapija (sa 162 ġurnata f'pazjenti adulti u sa 87 ġurnata f'pazjenti pedjatriċi).
English: Paediatric patients (12 months to 17 years)
Maltese: Pazjenti pedjatriċi (12-il xahar sa 17-il sena)
English: Preparation notes:
Maltese: Noti dwar il-preparazzjoni:
English: INSTRUCTIONS FOR USE IN ADULT PATIENTS (Caspofungin Accord 50 mg)
Maltese: ADULTI (Caspofungin Accord 50 mg)
English: Metabolism and nutrition disorders hypokalemia fluid overload, hypomagnesaemia, anorexia, electrolyte imbalance, hyperglycaemia, hypocalcaemia, metabolic acidosis
Maltese: Disturbi filmetaboliżmu u nnutrizzjoni ipokalemija ammont żejjed ta' fluwidu, ipomanjeżamija, anoreksja, żbilanċ fl-elettroliti, ipergliċemija, ipokalċemija, aċidożi metabolika
English: The safety and efficacy of caspofungin was evaluated in paediatric patients 3 months to 17 years of age in two prospective, multicentre clinical trials.
Maltese: Is-sigurtà u l-effikaċja ta' caspofungin ġiet evalwata f'pazjenti pedjatriċi minn 3 xhur sa 17-il sena f'żewġ provi kliniċi prospettivi multiċentri.
English: Caspofungin acetate is a semi-synthetic lipopeptide (echinocandin) compound synthesised from a fermentation product of Glarea lozoyensis.
Maltese: L-aċetat ta' caspofungin huwa kompost ta' lipopeptide (echinocandin) semisintetiku sintetizzat minn prodott ta' fermentazzjoni ta' Glarea lozoyensis.
English: PREPARATION OF THE SOLUTION FOR INFUSION IN ADULTS
Maltese: PREPARAZZJONI TAS-SOLUZZJONI GĦAL INFUŻJONI FL-ADULTI
English: • Changes in some laboratory blood tests (including increased values of some liver tests)
Maltese: • Tibdiliet f'xi testijiet tad-demm tal-laboratorju (inkluż żieda fil-valuri ta' xi testijiet tal-fwied)
English: General disorders and administration site conditions pyrexia, chills, infusion-site pruritus pain, catheter site pain, fatigue, feeling cold, feeling hot, infusion site erythema, infusion site induration, infusion site pain, infusion site swelling, injection site phlebitis, oedema peripheral, tenderness, chest discomfort, chest pain, face oedema, feeling of body temperature change, induration, infusion site extravasation, infusion site irritation, infusion site phlebitis, infusion site rash, infusion site urticaria, injection site erythema, injection site oedema, injection site pain, injection site swelling, malaise, oedema
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata deni, tkexkix ta' bard, ħakk fis-sit tal-infużjoni uġigħ, uġigħ fis-sit tal-katiter, għeja, bard, sħana, eritema fis-sit ta' infużjoni, twebbis tas-sit ta' infużjoni, uġigħ fis-sit ta' infużjoni, flebite fis-sit tal-injezzjoni, edema periferali, sensittività, skumdità fissider, uġigħ fis-sider, edema filwiċċ, ħass ta' bidla fit-temperatura tal-ġisem, twebbis, ekstravażazzjoni fis-sit ta' infużjoni, irritazzjoni tassit ta' infużjoni, flebite tas-sit ta' infużjoni, raxx fis-sit ta' infużjoni, urtikarja fis-sit ta' infużjoni, eritema tas-sit ta' injezzjoni, edema fis-sit ta' injezzjoni, uġigħ fis-sit ta' injezzjoni, nefħa fis-sit ta' injezzjoni, telqa, edema
English: In elderly patients (65 years of age or more), the area under the curve (AUC) is increased by approximately 30 %.
Maltese: Fil-pazjenti adulti (65 sena jew aktar), l-erja taħt il-kurva (AUC) tiżdied b'madwar 30%.
English: • Caspofungin Accord has not been studied in pregnant women.
Maltese: • Caspofungin Accord ma ġiex studjat f'nisa tqal.
English: 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.
Maltese: 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 tattrattament.
English: 35 mg for moderate hepatic impairment (from one 70 mg vial)
Maltese: 35 mg għal indeboliment epatiku moderat (minn kunjett wieħed ta' 70 mg)
English: Reconstitution of Caspofungin Accord
Maltese: Tużax Caspofungin Accord
English: Therefore, elimination occurs in the absence of a distribution equilibrium, and a true estimate of the volume of distribution of caspofungin is currently impossible to obtain.
Maltese: Għaldaqstant, isseħħ eliminazzjoni fin-nuqqas ta' ekwilibriju ta' distribuzzjoni, u stima reali tal-volum ta' distribuzzjoni ta' caspofungin hija attwalment impossibbli li tinkiseb.
English: Concomitant use of caspofungin with cyclosporin has been evaluated in healthy adult volunteers and in adult patients.
Maltese: L-użu konkomitanti ta' caspofungin ma' cyclosporin ġie evalwat f'voluntiera adulti b'saħħithom u f'pazjenti adulti.
English: • serious fungal infections in your tissues or organs (called ‘invasive candidiasis').
Maltese: • infezzjonijiet serji kkawżati minn fungu fit-tessuti jew fl-organi tiegħek (imsejħa kandidjasi invażiva).
English: There were 1,095 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)].
Maltese: 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.
English: All adolescents received doses >50 mg daily, and, in fact, 6 of 8 received the maximum dose of 70 mg/day.
Maltese: L-adoloxxenti kollha rċevew dożi ta' >50 mg kuljum, u, fil-fatt, 6 minn 8 irċevew id-doża massima ta' 70 mg/kuljum.
English: 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)].
Maltese: Mitejn u erbgħa u għoxrin pazjent kienu inklużi fl-analiżi primarja tal-effikaċja (analiżi MITT) tar-rispons fit-tmiem tatterapija 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.
English: Hepatic impairment: In adult patients with mild and moderate hepatic impairment, the AUC is increased about 20 and 75 %, respectively.
Maltese: F'pazjenti adulti b'indeboliment ħafif u moderat tal-fwied, l-AUC tiżdied madwar 20% u 75%, rispettivament.
English: • The other ingredients are sucrose, mannitol, succinic acid and sodium hydroxide (please see section 2.
Maltese: • Is-sustanzi l-oħra huma: sucrose, mannitol, succinic acid, u sodium hydroxide (jekk jogħġbok ara sezzjoni 2.
English: Cases of Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported after post-marketing use of caspofungin.
Maltese: Każijiet tas-Sindrome ta' Stevens-Johnson (SJS) u nekrolożi epidermali tossika (TEN) ġew irrapportati wara l-użu ta' caspofungin wara t-tqegħid fis-suq.
English: For those patients who received more than 7 days of therapy with caspofungin, 50 % (26/52) had a favourable response.
Maltese: Fil-każ ta' dawk il-pazjenti li rċevew iżjed minn 7 ijiem ta' terapija b'caspofungin, 50 % (26/52) kellhom rispons favorevoli.
English: Elderly: A modest increase in AUC (28 %) and C24h (32 %) was observed in elderly male subjects compared with young male subjects.
Maltese: Kienet osservata żieda modesta fl-AUC (28 %) u l-C24h (32 %) f'individwi rġiel anzjani meta mqabbel ma' rġiel żgħażagħ.
English: Accord
Maltese: LISTA
English: The mean duration of therapy was 33.7 days, with a range of 1 to 162 days.
Maltese: It-terapija damet medja ta' 33.7 ġranet, b'medda ta' 1 sa 162 ġurnata.
English: 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]).
Maltese: Ilbiċċa 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]).
English: Equilibrate the refrigerated vial of Caspofungin Accord to room temperature.
Maltese: Ġib il-kunjett imkessaħ ta' Caspofungin Accord għat-temperatura tal-kamra.
English: Empirical Therapy in Febrile, Neutropaenic Adult Patients: A total of 1,111 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.
Maltese: Total ta' 1111-il pazjent b'deni persistenti 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.
English: 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).
Maltese: 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% talpazjenti ttrattati) jew għal 5.0 mg/kg/kuljum ta' amphotericin B liposomali (14.3 % tal-pazjenti ttrattati).
English: Stability data have shown that the product can be used within 24 hours when stored at 25°C or less, or within 48 hours when the intravenous infusion bag (bottle) is stored refrigerated (2 to 8°C) and diluted with sodium chloride solution 9 mg/mL (0.9 %), 4.5 mg/mL (0.45 %), or 2.25 mg/mL (0.225 %) for infusion, or lactated Ringer's solution.
Maltese: Informazzjoni dwar listabilità wriet li l-prodott jista' jintuża fi żmien 24 siegħa meta jinħażen f'temperatura ta' 25°C jew inqas, jew fi żmien 48 siegħa meta l-borża (flixkun) tal-infużjoni fil-vini tinħażen fi friġġ (2 sa 8°C) u tkun dilwita b'soluzzjoni ta' klorur tas-sodju 9 mg/mL (0.9 %), 4.5 mg/mL (0.45 %), jew 2.25 mg/mL (0.225 %) għal infużjoni, jew soluzzjoni lactated ta' Ringer.
English: Calculation of Body Surface Area (BSA) for paediatric dosing
Maltese: Kalkulazzjoni tal-Arja tas-Superfiċje tal-Ġisem (BSA) għal dożaġġ pedjatriku
English: Caspofungin Accord contains a medicine called caspofungin.
Maltese: Caspofungin Accord fih mediċina msejħa caspofungin.
English: Of these, 37 had invasive candidiasis, 10 had invasive aspergillosis, and 1 patient had esophageal candidiasis.
Maltese: Minn dawn, 37 kellhom kandidjasi invażiva, 10 kellhom asperġillożi invażiva, u pazjent wieħed kellu kandidjasi esofagali.
English: • Changes in some laboratory blood tests.
Maltese: • Tkexkix ta' bard • Tibdil f'xi testijiet tad-demm tal-laboratorju
English: This infection is caused by a mould called Aspergillus.
Maltese: Din l-infezzjoni hija kkawżata minn moffa msejħa Aspergillus.
English: 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-A2 (for Aspergillus species) and method M27-A3 (for Candida species).
Maltese: L-ittestjar tas-suxxettibilità sar skont modifika kemm tal-metodu M38-A2 (għall-ispeċijiet Aspergillus) tal-Istitut għall-Istandards Kliniċi u tal-Laboratorju (CLSI, li qabel kien magħruf bħala lKumitat Nazzjonali għall-Istandards tal-Laboratorji
English: • Decreased blood albumin (a type of protein) in your blood, decreased potassium or low potassium levels in the blood
Maltese: • Tnaqqis fl-albumina (tip ta' proteina) fid-demm tiegħek, tnaqqis fil-livelli jew livelli baxxi ta'
English: • Catheter site pain, injection site complaints (redness, hard lump, pain, swelling, irritation, rash, hives, leaking of fluid from the catheter into the tissue), inflammation of vein at injection site
Maltese: • Uġigħ fis-sit tal-kateter, ilmenti fis-sit tal-injezzjoni (ħmura, għoqda iebsa, uġigħ, nefħa, irritazzjoni, raxx, ħorriqija, tnixxija ta' fluwidu mill-kateter għal ġot-tessut), infjammazzjoni ta' vina fil-post tal-injezzjoni
English: Co-administration with inducers of metabolic enzymes Limited data suggest that an increase in the daily dose of caspofungin to 70 mg, following the 70 mg loading dose, should be considered when co-administering caspofungin in adult patients with certain inducers of metabolic enzymes (see section 4.5).
Maltese: Għoti fl-istess ħin ma' indutturi ta' enzimi metaboliċi Informazzjoni limitata tissuġġerixxi li għandha tiġi kkunsidrata żieda fid-doża ta' kuljum ta' caspofungin għal 70 mg, wara l-loading dose ta' 70 mg, meta caspofungin jingħata f'pazjenti adulti flistess ħin ma' ċerti indutturi ta' enzimi metaboliċi (ara sezzjoni 4.5).
English: The elimination of caspofungin from plasma is slow with a clearance of 10-12 mL/min.
Maltese: L-eliminazzjoni ta' caspofungin mill-plażma sseħħ bil-mod bi tneħħija ta' 10-12 mL/min.
English: The unbound fraction of caspofungin in plasma varies from 3.5 % in healthy volunteers to 7.6 % in patients with invasive candidiasis.
Maltese: Il-frazzjoni mhux imwaħħla ta' caspofungin filplażma tvarja minn 3.5% f'voluntiera b'saħħithom għal 7.6% f'pazjenti b'kandidjasi invażiva.
English: Similarly, C. parapsilosis isolates intermediate to anidulafungin and micafungin can be regarded intermediate to caspofungin.
Maltese: B'mod simili iżolati ta' C. parapsilosis intermedji għal anidulafunginu micafungin jistgħu jitqiesu intermedji għal caspofungin.
English: The concentrations of the reconstituted vials will be 5.2 mg/mL.
Maltese: Il-konċentrazzjoni tal-kunjetti rikostitwiti se tkun 5.2 mg/mL.
English: Caspofungin Accord 70 mg powder for concentrate for solution for infusion 10 mL Type I clear glass vial with bromobutyl rubber stopper and orange aluminium seal with transparent plastic flip off button.
Maltese: Caspofungin Accord 70 mg għal trab konċentrat għal soluzzjoni għal infużjoni Kunjett tal-ħġieġ ċar ta' Tip I ta' 10 mL b'tapp tal-lastku tal-bromobutyl u siġill tal-aluminju oranġjo b'buttuna tal-plastik trasparenti li tista' tinqala'.
English: Respiratory, thoracic and mediastinal disorders dyspnoea nasal congestion, pharyngolaryngeal pain, tachypnoea, bronchospasm, cough, dyspnoea paroxysmal nocturnal, hypoxia, rales, wheezing
Maltese: Disturbi respiratorji, toraċiċi u medjastinali dispneja konġestjoni nasali, uġigħ farinġolarinġeali, takipnea, bronkospasmi, sogħla, dispnea parossimali notturnali, ipoksja, ħsejjes tal-pulmun, tħarħir
English: cholestasis, hepatomegaly, hyperbilirubinaemia, jaundice, hepatic function abnormal, hepatotoxicity, liver disorder, gamma-glutamyltransferase increased
Maltese: kolestażi, epatomegalija, iperbilirubinemija, suffejra, funzjoni tal-fwied anormali, tossiċità talfwied, disturbi fil-fwied, żieda filgamma-glutamyltransferase
English: Weight: Weight was found to influence caspofungin pharmacokinetics in the population pharmacokinetic analysis in adult candidiasis patients.
Maltese: Piż: Il-piż instab li jaffettwa l-farmakokinetiċi ta' caspofungin fl-analiżi farmakokinetika talpopolazzjoni f'pazjenti adulti f'kandidjasi.