FrancophonIA/ELRC3.0 huggingface dataset:
English: Considering that all patients were treated for high risk solid tumours, DFS results confirm that conditioning treatments containing thiotepa following autologous HPCT are effective therapeutic strategies for treating paediatric patients with solid tumours.
Maltese: Meta wieħed iqis li l-pazjenti kollha kienu kkurati għal tumuri solidi ta' riskju għoli, ir-riżultati ta' DFS jikkonfermaw li l-kuri ta' kondizzjonament li fihom thiotepa wara HPCT awtologu huma strateġiji terapewtiċi effettivi għall-kura ta' pazjenti pedjatriċi b'tumuri solidi.
English: Haemorrhage Embolism
Maltese: Emorraġija vaġinali
English: In pre-clinical studies thiotepa, as most alkylating agents, has been shown to cause embryofoetal lethality and teratogenicity (see section 5.3).
Maltese: Fi studji prekliniċi thiotepa, bħall-parti lkbira tas-sustanzi alkilanti, intwera li jikkawża l-mewt tal-embriju u teratoġeniċità (ara sezzjoni 5.3).
English: Special populations
Maltese: diversi organi
English: Chemical and physical in-use stability after dilution has been demonstrated for 24 hours when stored at 2°C -8°C and for 4 hours when stored at 25°C.
Maltese: Intweriet stabilità kimika u fiżika waqt l-użu wara r-rikostituzzjoni għal 24 siegħa meta jinżamm maħżun f'temperatura ta' 2°C-8°C u għal 4 sigħat meta miżmum f'temperatura ta' 25 °C.
English: The high intra-individual variability of the coagulation state during malignancy, and the potential interaction between oral anticoagulants and anticancer chemotherapy require, if it is decided to treat the patient with oral anticoagulants, to increase the frequency of the INR (International Normalised Ratio) monitoring.
Maltese: jekk jiġi deċiż li l-pazjent għandu jingħata kura orali kontra l-koagulazzjoni, li tiżdied il-frekwenza tal monitoraġġ INR (Poporzjoni Normalizzat Internazzjonali - International Normalised Ratio).
English: The recommended dose in solid tumours ranges from 120 mg/m2/day (3.24 mg/kg/day) to 250 mg/m2/day (6.76 mg/kg/day) divided in one or two daily infusions, administered from 2 up to 5 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 800 mg/m2 (21.62 mg/kg), during the time of the entire conditioning treatment.
Maltese: Id-doża rakkomandata fit-tumuri solidi tvarja minn 120 mg/m2/ġurnata (3.24 mg/kg/ġurnata) sa 250 mg/m2/ġurnata (6.76 mg/kg/ġurnata) maqsuma f'infużjoni waħda jew tnejn kuljum, mogħtija minn 2 sa 5 ijiem wara xulxin qabel HPCT awtologu skont il-kombinazzjoni ma' prodotti mediċinali kimoterapewtiċi oħra, mingħajr ma tinqabeż id-doża massima kumulattiva totali ta' 800 mg/m2 (21.62 mg/kg), matul il-perjodu tat-trattament sħiħ ta' kundizzjonament.
English: The recommended dose in haematological diseases ranges from 125 mg/m2/day (5 mg/kg/day) to 250 mg/m2/day (10 mg/kg/day) divided in one or two daily infusions, administered from 1 up to 3 consecutive days before allogeneic HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 375 mg/m2 (15 mg/kg), during the time of the entire conditioning treatment.
Maltese: Id-doża rakkomandata f'mard ematoloġiku tvarja minn 125 mg/m2/jum (5 mg/kg/jum) sa 250 mg/m2/jum (10 mg/kg/jum) maqsuma f'infużjoni waħda jew f'żewġ infuzjonijiet kuljum, li jingħataw minn ġurnata sa 3 ijiem konsekuttivi qabel l-HPCT alloġeneiku skont il-kombinazzjoni ma' prodotti mediċinali kemoterapewtiċi oħrajn, mingħajr ma tinqabeż id-doża kumulattiva massima totali ta' 375 mg/m2 (15 mg/kg), matul il-perijodu kollu ta' kura ta' kondizzjonament.
English: In children, if the dose is lower than 250 mg, an appropriate volume of sodium chloride 9 mg/ml (0.9%) solution for injection may be used in order to obtain a final TEPADINA concentration between 0.5 and 1 mg/ml.
Maltese: Fi tfal, jekk id-doża hi inqas minn 250 mg, volum xieraq ta' 9 mg/ml (0.9%) soluzzjoni ta' sodium chloride għall-injezzjoni tista' tintuża sabiex tinkiseb konċentrazzjoni finali ta' TEPADINA ta' bejn 0.5 u 1 mg/ml.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Ewropea għall-Mediċini http://www.ema.europa.eu.
English: Lymphoedema Hypertension
Maltese: MARD ĠENETIKU
English: The conditioning treatment must provide cytoreduction and ideally disease eradication.
Maltese: Il-kura ta' kondizzjonament għandha tipprovdi ċitoriduzzjoni u idealment l-eliminazzjoni tal-marda.
English: Co-administration of inducers of cytochrome P450 (such as rifampicin, carbamazepine, phenobarbital) may increase the metabolism of thiotepa leading to increased plasma concentrations of the active metabolite.
Maltese: Il-ko-amministrazzjoni ta' indutturi ta' cytochrome P450 (bħal rifampicin, carbamazepine,
English: - anxiety, confusion - abnormal bulging outward of one of the arteries in the brain (intracranial aneurysm) - creatinine elevated - allergic reactions - occlusion of a blood vessel (embolism) - heart rhythm disorder - heart inability - cardiovascular inability - oxygen deficiency - fluid accumulation in the lungs (pulmonary oedema) - pulmonary bleeding - respiratory arrest - blood in the urine (haematuria) and moderate renal insufficiency - inflammation of the urinary bladder - discomfort in urination and decrease in urine output (disuria and oliguria) - increase in the amount of nitrogen components in the blood stream (BUN increase) - cataract - inability of the liver - cerebral haemorrhage - cough - constipation and upset stomach - obstruction of the bowel - perforation of stomach - changes in muscle tone - gross lack of coordination of muscle movements - bruises due to a low platelet count - menopausal symptoms - cancer (second primary malignancies) - abnormal brain function - male and female infertility
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa 1 minn kull 10 persuni) - ansjetà, konfużjoni - tqabbiż abnormali 'l barra ta' waħda mill-arterji fil-moħħ (anewriżma ġol-kranju) - livell għoli ta' kreatinina - reazzjonijiet allerġiċi - okklużjoni ta' vina jew arterja (emboliżmu)
English: Azoospermia Amenorrhoea Vaginal haemorrhage
Maltese: Disturbi vaskulari Limfoedema
English: TEPADINA 100 mg powder for concentrate for solution for infusion Thiotepa
Maltese: Informazzjoni għall-utent TEPADINA 100 mg trab għal konċentrat għal soluzzjoni għal infużjoni thiotepa
English: After dilution the product is stable for 24 hours when stored at 2°C -8°C and for 4 hours when stored at 25°C.
Maltese: Wara diluzzjoni, il-prodott huwa stabbli għal 24 siegħa meta jinħażen f'temperatura ta' 2°C -8°C u għal 4 sigħat meta jinżamm f'temperatura ta' 25°C.
English: The recommended dose in solid tumours ranges from 150 mg/m2/day (6 mg/kg/day) to 350 mg/m2/day (14 mg/kg/day) as a single daily infusion, administered from 2 up to 3 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 1050 mg/m2 (42 mg/kg), during the time of the entire conditioning treatment.
Maltese: Id-doża rakkomandata f'tumuri solidi tvarja minn 150 mg/m2/jum (6 mg/kg/jum) sa 350 mg/m2/jum (14 mg/kg/jum) bħala infużjoni waħda kuljum, li tingħata minn jumejn sa 3 ijiem konsekuttivi qabel lHPCT awtologu skont il-kombinazzjoni ma' prodotti mediċinali kemoterapewtiċikemoterapewtiċi oħrajn, mingħajr ma tinqabeż id-doża kumulattiva massima totali ta' 1050 mg/m2 (42 mg/kg), matul il perijodu kollu ta' kura ta' kondizzjonament.
English: The recommended dose ranges from 125 mg/m2/day (3.38 mg/kg/day) to 300 mg/m2/day (8.10 mg/kg/day) as a single daily infusion, administered from 2 up to 4 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 900 mg/m2 (24.32 mg/kg), during the time of the entire conditioning treatment.
Maltese: Id-doża rakkomandata tvarja minn 125 mg/m2/ġurnata (3.38 mg/kg/ġurnata) sa 300 mg/m2/ġurnata (8.10 mg/kg/ġurnata) bħala infużjoni waħda kuljum, mogħtija minn 2 sa 4 ijiem wara xulxin qabel HPCT awtologu skont il-kombinazzjoni ma' prodotti mediċinali kimoterapewtiċi oħra, mingħajr ma tinqabeż id-doża massima kumulattiva totali ta' 900 mg/m2 (24.32 mg/kg), matul il-perjodu tattrattament sħiħ ta' kundizzjonament.
English: Concomitant use to take into consideration Ciclosporine, tacrolimus: excessive immunosuppression with risk of lymphoproliferation.
Maltese: Użu konkomitanti li għandu jiġi kkunsidrat Ciclosporine, tacrolimus: immunosoppressjoni eċċessiva b'risku ta' proliferazzjoni tal-limfomi.
English: Thiotepa is a weak inhibitor for CYP2B6, and may thereby potentially increase plasma concentrations of substances metabolised via CYP2B6, such as ifosfamide, tamoxifen, bupropion, efavirenz and cyclophosphamide.
Maltese: Thiotepa huwa inibitur dgħajjef għal CYP2B6, u minħabba f'hekk jista' potenzjalment iżid ilkonċentrazzjonijiet fil-plażma ta' sustanzi metabolizzati permezz ta' CYP2B6, bħal ifosfamide,
English: Thiotepa has not been studied in patients with hepatic impairment.
Maltese: Thiotepa ma ġiex studjat f'pazjenti b'indeboliment epatiku.
English: TRM values ranged from 0% to 18% confirming the safety of the conditioning treatments including thiotepa for autologous HPCT in paediatric patients with solid tumours.
Maltese: Il-valuri TRM kienu jvarjaw minn 0% sa 18% li jikkonferma s-sigurtà tal-kuri ta' kondizzjonament li jinkludu thiotepa għal HPCT awtologu f'pazjenti pedjatriċi b'tumuri solidi.
English: TEPADINA 15 mg powder for concentrate for solution for infusion
Maltese: TEPADINA 15 mg trab għal konċentrat għal soluzzjoni għal infużjoni
English: TEPADINA is administered at different doses in combination with other chemotherapeutic medicinal products in patients prior to conventional haematopoietic progenitor cell transplantation (HPCT) for haematological diseases or solid tumours.
Maltese: Kalkulazzjoni tad-doża ta' TEPADINA TEPADINA jingħata f'dożi differenti flimkien ma' prodotti mediċinali kimoterapewtiċi oħra lill pazjenti qabel trapjant konvenzjonali ta' ċelluli proġenituri ematopoitiċi (HPCT) għal mard taddemm jew tumuri solidi.
English: The recommended dose in haematological diseases ranges from 185 mg/m2/day (5 mg/kg/day) to 481 mg/m2/day (13 mg/kg/day) divided in one or two daily infusions, administered from 1 up to 3 consecutive days before allogeneic HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 555 mg/m2 (15 mg/kg), during the time of the entire conditioning treatment.
Maltese: Id-doża rakkomandata f'mard ematoloġiku tvarja minn 185 mg/m2/jum (5 mg/kg/jum) sa 481 mg/m2/jum (13 mg/kg/jum) maqsuma f'infużjoni waħda jew f'żewġ infuzjonijiet kuljum, li jingħataw minn jum sa 3 ijiem konsekuttivi qabel l-HPCT alloġeniku skont il-kombinazzjoni ma' prodotti mediċinali kemoterapewtiċikemoterapewtiċi oħrajn, mingħajr ma tinqabeż id-doża kumulattiva massima totali ta' 555 mg/m2 (15 mg/kg), matul il-perijodu kollu ta' kura ta' kondizzjonament.
English: Thiotepa was shown to impair fertility and interfere with spermatogenesis in male mice, and to impair ovarian function in female mice.
Maltese: Thiotepa intwera li jfixkel il-fertilità u jinterferixxi mal-produzzjoni tal-isperma fil-ġrieden maskili, u li jfixkel il-funzjoni tal-ovarji fil-ġrieden femminili.
English: The recommended dose in haematological diseases ranges from 125 mg/m2/day (3.38 mg/kg/day) to 300 mg/m2/day (8.10 mg/kg/day) as a single daily infusion, administered from 2 up to 4 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 900 mg/m2 (24.32 mg/kg), during the time of the entire conditioning treatment.
Maltese: Id-doża rakkomandata fil-mard tad-demm tvarja minn 125 mg/m2/ġurnata (3.38 mg/kg/ġurnata) sa 300 mg/m2/ġurnata (8.10 mg/kg/ġurnata) bħala infużjoni waħda kuljuum mogħtija minn 2 sa 4 ijiem wara xulxin qabel HPCT awtologu skont il-kombinazzjoni ma' prodotti mediċinali kimoterapewtiċi oħra, mingħajr ma tinqabeż id-doża massima kumulattiva totali ta' 900 mg/m2 (24.32 mg/kg), matul ilperjodu tat-trattament sħiħ ta' kundizzjonament.
English: - Keep this leaflet.
Maltese: li sseħħ fil-pazjenti kollha.
English: Concomitant use with yellow fever vaccine and with live virus and bacterial vaccines (see section 4.5).
Maltese: L-użu konkomitanti mal-vaċċin tad-deni l-isfar u mal-virus ħaj u vaċċini batteriċi (ara sezzjoni 4.5). 4.4
English: TEPADINA must be reconstituted with 1.5 ml of sterile water for injection.
Maltese: TEPADINA għandu jiġi rikostitwit b'1.5 ml ta' ilma sterili għall-injezzjonijiet.
English: The recommended dose ranges from 120 mg/m2/day (3.24 mg/kg/day) to 250 mg/m2/day (6.76 mg/kg/day) as a single daily infusion, administered from 3 up to 5 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 800 mg/m2 (21.62 mg/kg), during the time of the entire conditioning treatment.
Maltese: Id-doża rakkomandata tvarja minn 120 mg/m2/ġurnata (3.24 mg/kg/ġurnata) sa 250 mg/m2/ġurnata (6.76 mg/kg/ġurnata) bħala infużjoni waħda kuljum, mogħtija minn 3 sa 5 ijiem wara xulxin qabel HPCT awtologu skont il-kombinazzjoni ma' prodotti mediċinali kimoterapewtiċi oħra, mingħajr ma tinqabeż id-doża massima kumulattiva totali ta' 800 mg/m2 (21.62 mg/kg), matul il-perjodu tattrattament sħiħ ta' kundizzjonament.
English: TEPADINA 100 mg powder for concentrate for solution for infusion
Maltese: TEPADINA 100 mg trab għal konċentrat għal soluzzjoni għal infużjoni
English: The results of published clinical studies supporting the efficacy of thiotepa are summarised:
Maltese: Ir-riżultati ta' studji kliniċi ppublikati li jappoġġjaw l-effikaċja ta'thiotepa huma mqassra:
English: (10 mg/kg), during the time of the entire conditioning treatment.
Maltese: 27 mg/kg), matul il perjodu tat-trattament sħiħ ta' kundizzjonament.
English: The recommended dose in lymphoma is 370 mg/m2/day (10 mg/kg/day) divided in two daily infusions before allogeneic HPCT, without exceeding the total maximum cumulative dose of 370 mg/m2
Maltese: Id-doża rakkomandata hija ta' 370 mg/m2/jum (10 mg/kg/jum) maqsuma f'żewġ infuzjonijiet kuljum, qabel l-HPCT alloġeneiku, mingħajr ma tinqabeż id-doża kumulattiva massima totali ta' 370 mg/m2
English: Dizziness Headache Vision blurred Encephalopathy Convulsion Paraesthesia
Maltese: Uġigħ ta' ras Vista mċajpra Enċefalopatija Konvulżjoni Paresteżija
English: After reconstitution with 1.5 ml of water for injection, each ml contains 10 mg thiotepa.
Maltese: Wara li jiġi rikostitwit b'1.5 ml ta' ilma għall-injezzjoni, kull 1 ml ikun fih 10 mg thiotepa.
English: The recommended dose ranges from 185 mg/m2/day (5 mg/kg/day) to 481 mg/m2/day (13 mg/kg/day) divided in one or two daily infusions, administered from 1 up to 2 consecutive days before allogeneic HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 555 mg/m2 (15 mg/kg), during the time of the entire conditioning treatment.
Maltese: Id-doża rakkomandata tvarja minn 185 mg/m2/ġurnata (5 mg/kg/ġurnata) sa 481 mg/m2/ġurnata (13 mg/kg/ġurnata) maqsuma f'infużjoni waħda jew tnejn kuljum, mogħtija minn jum sa jumejn wara xulxin qabel HPCT alloġeneiku skont il-kombinazzjoni ma' prodotti mediċinali terapewtiċi oħra, mingħajr ma tinqabeż id-doża massima kumulattiva totali ta' 555 mg/m2 (15 mg/kg), matul il-perjodu tat-trattament sħiħ ta' kundizzjonament.
English: TEPADINA is supplied as 100 mg powder for concentrate for solution for infusion.
Maltese: TEPADINA jiġi bħala 100 mg trab għal konċentrat għal soluzzjoni għal infużjoni.
English: Male patients should seek for sperm cryopreservation before therapy is started and should not father a child while treated and during the year after cessation of treatment (see section 4.6).
Maltese: Ilpazjenti maskili għandhom jistaqsu dwar il-krijopreservazzjoni tal-isperma qabel tibda l-kura u m'għandhomx inisslu tfal waqt il-kura u matul is-sena wara li tieqaf il-kura (ara sezzjoni 4.6).
English: Hearing impaired
Maltese: Disturbi vaskulari
English: The recommended dose is 370 mg/m2/day (10 mg/kg/day) divided in two daily infusions, administered before allogeneic HPCT, without exceeding the total maximum cumulative dose of 370 mg/m2 (10 mg/kg), during the time of the entire conditioning treatment.
Maltese: Id-doża rakkomandata hija 370 mg/m2/ġurnata (10 mg/kg/ġurnata) maqsuma f'żewġ infużjonijiet kuljum, mogħtija qabel HPCT alloġeneiku, mingħajr ma tinqabeż id-doża massima kumulattiva totali ta' 370 mg/m2 (10 mg/kg), matul il-perjodu tat-trattament sħiħ ta' kundizzjonament.
English: Urinary excretion of thiotepa and TEPA is nearly complete after 6 and 8 hours respectively.
Maltese: It-tneħħija fl-awrina ta' thiotepa u ta' TEPA tkun kważi kompluta wara 6 u 8 sigħat rispettivament.
English: The recommended dose in lymphoma is 370 mg/m2/day (10 mg/kg/day) divided in two daily infusions before allogeneic HPCT, without exceeding the total maximum cumulative dose of 370 mg/m2 (10 mg/kg), during the time of the entire conditioning treatment.
Maltese: Id-doża rakkomandata fil-limfoma hija ta' 370 mg/m2/jum (10 mg/kg/jum) maqsuma f'żewġ infuzjonijiet kuljum qabel l-HPCT alloġeneiku, mingħajr ma tinqabeż id-doża kumulattiva massima totali ta' 370 mg/m2 (10 mg/kg), matul il-perijodu kollu ta' kura ta' kondizzjonament.
English: Pigmentation disorder Erythrodermic psoriasis
Maltese: Żieda fl-alkaline phosphatase fiddemm
English: Posology in paediatric patients
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI
English: TEPADINA posology is reported, in adult and paediatric patients, according to the type of HPCT (autologous or allogeneic) and disease.
Maltese: Il-pożoloġija ta' TEPADINA hija rrappurtata, f'pazjenti adulti u pedjatriċi, skont it-tip ta' HPCT (awtologu jew alloġeneiku) u l-marda.
English: Immedica Pharma AB Sími: +46 (0)8 533 39 500
Maltese: Sími: +46 (0)8 533 39 500
English: Side effects of TEPADINA may occur with certain frequencies, which are defined as follows:
Maltese: L-effetti sekondarji ta' TEPADINA jistgħu jseħħu b'ċerti frekwenzi, li huma definiti kif ġej:
English: In some of the conditioning treatments evaluated, relapse rates lower than 60% have also been reported at 5 years.
Maltese: F'xi wħud mill-kuri ta' kondizzjonament evalwati, ġew irrappurtati wkoll rati ta' rikaduta aktar baxxi minn 60% wara 5 snin.
English: Generalised oedema
Maltese: Indeboliment eptiku
English: Uncommon side effects (may affect up to 1 in 100 people)
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa 1 minn kull 100 persuna)
English: Haemorrhage
Maltese: Oligurja
English: TEPADINA is a white crystalline powder supplied in a glass vial containing 15 mg thiotepa.
Maltese: TEPADINA huwa trab kristallin abjad li jiġi f'kunjett tal-ħġieġ li fih 15-il mg thiotepa.
English: Treatment related second malignancy
Maltese: Tumur malinn sekondarju relatat mal-kura
English: Remove the syringe and the needle and mix manually by repeated inversions.
Maltese: Neħħi s-siringa u l-labra u ħallat manwalment permezz ta' qlib ripetut.
English: Not known
Maltese: Insuffiċjenza ta'
English: Dysuria Oliguria Renal failure Cystitis Haematuria
Maltese: Kull kartuna fiha kunjett wieħed.
English: Thiotepa undergoes rapid and extensive hepatic metabolism and metabolites could be detected in urine within 1 hour after infusion.
Maltese: Thiotepa jgħaddi minn metaboliżmu epatiku rapidu u estensiv u jistgħu jinstabu metaboliti fl-awrina fi żmien siegħa wara l-infużjoni.
English: Pyrexia
Maltese: Tinnitus
English: EXP
Maltese: Thiotepa
English: Male patients should seek for sperm cryopreservation before therapy is started and should not father a child while treated and during the year after cessation of treatment (see section 5.3).
Maltese: Ilpazjenti maskili għandhom jistaqsu dwar il-krijopreservazzjoni tal-isperma qabel tibda l-kura u m'għandhomx inisslu tfal waqt il-kura u matul is-sena wara li tieqaf il-kura (ara sezzjoni 5.3).
English: Using a syringe fitted with a needle, aseptically withdraw 1.5 ml of sterile water for injection.
Maltese: Billi tuża siringa b'labra mwaħħla, iġbed b'mod asettiku 1.5 ml ta' ilma sterili għall-injezzjonijiet.
English: Epistaxis Hypoxia
Maltese: Hypopituitarism Hypogonadism Hypothyroidism
English: Thiotepa is unreliably absorbed from the gastrointestinal tract: acid instability prevents thiotepa from being administered orally.
Maltese: Dan inkiseb bil-korsijiet kollha ta' kondizzjonament irrappurtati li jinkludu thiotepa.
English: Intracranial aneurysm Extrapyramidal disorder
Maltese: Disturb ekstrapiramidali
English: Women of childbearing potential
Maltese: - inabilità kardjovaskulari
English: The recommended dose ranges from 150 mg/m2/day (4.05 mg/kg/day) to 250 mg/m2/day (6.76 mg/kg/day) as a single daily infusion, administered for 3 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 750 mg/m2 (20.27 mg/kg), during the time of the entire conditioning treatment.
Maltese: Id-doża rakkomandata tvarja minn 150 mg/m2/ġurnata (4.05 mg/kg/ġurnata) sa 250 mg/m2/ġurnata (6.76 mg/kg/ġurnata) bħala infużjoni waħda kuljum, mogħtija għal 3 ijiem wara xulxin qabel HPCT awtologu skont il-kombinazzjoni ma' prodotti mediċinali kimoterapewtiċi oħra, mingħajr ma tinqabeż id-doża massima kumulattiva totali ta' 750 mg/m2 (20.
English: TEPADINA 15 mg powder for concentrate for solution for infusion Thiotepa
Maltese: IL-PRODOTT MEDIĊINALI TEPADINA 15 mg trab għal konċentrat għal-soluzzjoni għall-infużjoni
English: The recommended dose is 185 mg/m2/day (5 mg/kg/day) as a single daily infusion before allogeneic HPCT, without exceeding the total maximum cumulative dose of 185 mg/m2 (5 mg/kg), during the time of the entire conditioning treatment.
Maltese: Id-doża rakkomandata hija 185 mg/m2/ġurnata (5 mg/kg/ġurnata) bħala infużjoni waħda kuljum qabel HPCT alloġeneiku, mingħajr ma tinqabeż id-doża massima kumulattiva totali ta' 185 mg/m2 (5 mg/kg),
English: CENTRAL NERVOUS SYSTEM (CNS) LYMPHOMA The recommended dose is 185 mg/m2/day (5 mg/kg/day) as a single daily infusion, administered for 2 consecutive days before autologous HPCT, without exceeding the total maximum cumulative dose of 370 mg/m2 (10 mg/kg), during the time of the entire conditioning treatment.
Maltese: Id-doża rakkomandata hija ta' 185 mg/m2/jum (5 mg/kg/jum) bħala infużjoni waħda kuljum, li tingħata għal jumejn konsekuttivi qabel l-HPCT awtologu, mingħajr ma tinqabeż id-doża kumulattiva massima totali ta' 370 mg/m2 (10 mg/kg), matul il-perijodu kollu ta' kura ta' kondizzjonament.
English: AUTOLOGOUS HPCT
Maltese: HPCT ALLOĠENEIKU
English: Autologous HPCT
Maltese: HPCT alloġeneiku
English: The recommended dose is 250 mg/m2/day (6.76 mg/kg/day) as a single daily infusion, administered in 2 consecutive days before autologous HPCT, without exceeding the total maximum cumulative dose of 500 mg/m2 (13.51 mg/kg), during the time of the entire conditioning treatment.
Maltese: Id-doża rakkomandata hija ta' 250 mg/m2/jum (6.76 mg/kg/jum) bħala infużjoni waħda kuljum, li tingħata f'jumejn konsekuttivi qabel l-HPCT awtologu, mingħajr ma tinqabeż id-doża kumulattiva massima totali ta' 500 mg/m2 (13.51 mg/kg), matul il-perijodu kollu ta' kura ta' kondizzjonament.