FrancophonIA/ELRC3.0 huggingface dataset:
English: However, caution is recommended (see sections 4.4 and 5.2).
Maltese: Madankollu, hija rrakkomandata kawtela (ara sezzjonijiet 4.4 u 5.2).
English: All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety hood.
Maltese: preferibbilment billi jintuża vertical laminar flow safety hood.
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskoluskeletali u tat-tessuti konnettivi
English: Co-administration with inhibitors of CYP2B6 (for example clopidogrel and ticlopidine) or CYP3A4 (for example azole antifungals, macrolides like erythromycin, clarithromycin, telithromycin, and protease inhibitors) may increase the plasma concentrations of thiotepa and potentially decrease the concentrations of the active metabolite TEPA.
Maltese: L-għoti flimkien ma' inibituri ta' CYP2B6 (pereżempju clopidogrel u ticlopidine) jew CYP3A4 (pereżempju antifungali azole, makrolidi bħal erythromycin, clarithromycin, telithromycin, u inibituri protease) jista' jżid ilkonċentrazzjonijiet ta' thiotepa fil-plażma u potenzjalment inaqqas il-konċentrazzjonijiet tal-metabolit attiv TEPA.
English: CYP2B6 catalyzes the metabolic conversion of cyclophosphamide to its active form 4-hydroxycyclophosphamide (4-OHCP) and co-administration of thiotepa may therefore lead to decreased concentrations of the active 4-OHCP.
Maltese: CYP2B6 jikkatalizza l-konverżjoni metabolika ta' cyclophosphamide għall-forma attiva tiegħu 4-hydroxycyclophosphamide (4-OHCP) u l-koamministrazzjoni ta' thiotepa tista' għalhekk twassal għal tnaqqis fil-konċentrazzjonijiet tal-4-OHCP attiv.
English: Store and transport refrigerated (2°C - 8°C).
Maltese: Aħżen u ġorr fi friġġ (2°C - 8°C).
English: The apparent volume of distribution of thiotepa appears independent of the administered dose.
Maltese: Il-volum apparenti ta' distribuzzjoni ta' thiotepa jidher indipendenti mid-doża amministrata.
English: Endocrine disorders
Maltese: Disturbi endokrinarji
English: LYMPHOMA
Maltese: LIMFOMA
English: Overall Survival: OS ranged from 31% to 81% with a follow-up ranging from 7.3 up to 120 months.
Maltese: Sopravvivenza Globali: l-OS kien ivarja minn 31% sa 81% b'segwitu li jvarja minn 7.3 sa 120 xahar.
English: Enteritis Intestinal obstruction
Maltese: Enterite Ostruzzjoni intestinali
English: LYMPHOMA The recommended dose ranges from 125 mg/m2/day (3.38 mg/kg/day) to 300 mg/m2/day
Maltese: LIMFOMA Id-doża rakkomandata tvarja minn 125 mg/m2/jum (3.38 mg/kg/jum) sa 300 mg/m2/jum
English: Pregnancy and lactation (see section 4.6).
Maltese: Fertilità, tqala u treddigħ (ara sezzjoni 4.6).
English: Thiotepa might induce pulmonary toxicity that may be additive to the effects produced by other cytotoxic agents (busulfan, fludarabine and cyclophosphamide) (see section 4.8).
Maltese: Thiotepa jista' jikkawża tossiċità pulmonari li tista' tiżdied mal-effetti prodotti minn sustanzi ċitotossiċi oħrajn (busulfan, fludarabine u cyclophosphamide) (ara sezzjoni 4.8).
English: Immune system disorders
Maltese: Disturbi tas-sistema immunitarja
English: Thiotepa is a highly lipophilic compound.
Maltese: Thiotepa huwa kompost lipofiliku ħafna.
English: After reconstitution, each ml contains 10 mg thiotepa (10 mg/ml).
Maltese: 1 ml ikun fih 10 mg thiotepa (10 mg/ml).
English: Pancytopenia Granulocytopenia
Maltese: Popolazzjoni pedjatrika
English: The mean urinary recovery of thiotepa and its metabolites is 0.5% for the unchanged medicinal product and monochlorotepa, and 11% for TEPA and thiotepa-mercapturate.
Maltese: L-irkupru medju fl-awrina ta' thiotepa u l-metaboliti tiegħu huwa ta' 0.5% għall-prodott mediċinali mhux mibdul u monochlorotepa, u 11% għal TEPA u thiotepa-mercapturate.
English: During conversion of GSH conjugates to N-acetylcysteine conjugates, GSH, cysteinylglycine, and cysteine conjugates are formed.
Maltese: jiffurmaw konjugati GSH, cysteinylglycine, u cysteine.
English: TEPADINA is indicated, in combination with other chemotherapy medicinal products:
Maltese: TEPADINA huwa indikat, flimkien ma' prodotti mediċinali għall-kemoterapija oħrajn:
English: The total excreted amount of thiotepa and its identified metabolites accounts for 54-100% of the total alkylating activity, indicating the presence of other alkylating metabolites.
Maltese: L-ammont totali mneħħi ta' thiotepa u l-metaboliti identifikati tiegħu huwa responsabbli għal 54-100% tal-attività alkilanti totali, li jindika l-preżenza ta' metaboliti alkilanti oħrajn.
English: The concomitant use of thiotepa and other myelosuppressive or myelotoxic agents (i.e. cyclophosphamide, melphalan, busulfan, fludarabine, treosulfan) may potentiate the risk of haematologic adverse reactions due to overlapping toxicity profiles of these medicinal products.
Maltese: L-użu konkomitanti ta' thiotepa u sustanzi majelosoppressivi jew majelotossiċi oħrajn (jiġifieri cyclophosphamide, melphalan, busulfan, fludarabine, treosulfan) jista' jżid ir-riskju ta' reazzjonijiet avversi ematoloġiċi minħabba l-profili simili ta' tossiċità ta' dawn il-prodotti mediċinali.
English: Blood bilirubin increased Transaminases increased Blood creatinine increased Aspartate aminotransferase increased Alanine aminotransferase increased
Maltese: Żieda fl-aspartate aminotransferase Żieda fl-alanine aminotransferase
English: One vial contains 15 mg thiotepa.
Maltese: Kunjett wieħed fih 15 mg thiotepa.
English: PRESENTATION
Maltese: LISTA
English: TRM values ranged from 0% to 7.4% confirming the safety of the conditioning treatment including thiotepa for autologous HPCT in adult patients with solid tumours.
Maltese: Il-valuri TRM kienu jvarjaw minn 0% sa 7.4% li jikkonferma s sigurtà tal-kuri ta' kondizzjonament li jinkludu thiotepa għal HPCT awtologu f'pazjenti adulti b'tumuri solidi.
English: Teл.
Maltese: Xejn.
English: The safety of thiotepa has been examined through a review of adverse events reported in published data from clinical trials.
Maltese: Is-sigurtà ta' thiotepa ġiet eżaminata permezz ta' reviżjoni tal-avvenimenti avversi rrappurtati f'dejta ppubblikata minn provi kliniċi.
English: Phenytoin: risk of exacerbation of convulsions resulting from the decrease of phenytoin digestive absorption by cytotoxic medicinal product or risk of toxicity enhancement and loss of efficacy of the cytotoxic medicinal product due to increased hepatic metabolism by phenytoin.
Maltese: Phenytoin: riskju ta' taħrix ta' konvulżjonijiet li jirriżultaw mit-tnaqqis tal-assorbiment diġestiv ta' phenytoin minn prodott mediċinali ċitotossiku jew riskju ta' żieda ta' tossiċità u telf tal-effikaċja talprodott mediċinali ċitotossiku minħabba żieda fil-metaboliżmu epatiku permezz ta' phenytoin.
English: Overall Survival (OS): OS ranged from 29% to 87% with a follow-up ranging from 22 up to 63 months.
Maltese: Sopravvivenza Globali (Oversall Survival - OS): L-OS kien ivarja minn 29% sa 87% b'segwitu li jvarja minn 22 sa 63 xahar.
English: One vial contains 100 mg thiotepa.
Maltese: Kunjett wieħed fih 100 mg thiotepa.
English: Thrombocytopenic purpura
Maltese: Purpura tromboċitopenika
English: Pulmonary arterial hypertension
Maltese: Edema pulmonarja
English: Leukopenia Thrombocytopenia Febrile neutropenia Anaemia
Maltese: Newtropenja febbrili Anemija
English: Engraftment: Engraftment has been achieved (92%-100%) in all reported conditioning treatments and it was considered to occur at the expected time.
Maltese: It-trapjant inkiseb (92%-100%) fil-kuri kollha ta' kondizzjonament u ġie kkunsidrat li seħħ fiż-żmien mistenni.
English: For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.
Maltese: Għall-kundizzjonijiet ta' ħażna tal-prodott mediċinali rikostitwit u dilwit, ara sezzjoni 6.3. 6.5
English: Gastrointestinal ulcer
Maltese: Ulċera gastro intestinali
English: Prophylactic or empiric use of anti-infectives (bacterial, fungal, viral) should be considered for the prevention and management of infections during the neutropenic period.
Maltese: L-użu profilattiku jew empiriku ta' anti-infettivi (batteriċi, fungali, virali) għandu jiġi kkunsidrat għall prevenzjoni u l-immaniġġjar ta' infezzjonijiet waqt il-perijodu newtropeniku.
English: Idiopathic pneumonia syndrome Pulmunary haemorrage Pulmonary oedema
Maltese: Emorraġija pulmonari Edema pulmonari Epistassi
English: White crystalline powder.
Maltese: Trab abjad kristallin.
English: These metabolites are not found in urine, and, if formed, are probably excreted in bile or as intermediate metabolites rapidly converted into thiotepa-mercapturate.
Maltese: jekk jiffurmaw, probabbilment jitneħħew fil-bili jew bħala metaboliti intermedji kkonvertiti rapidament f' thiotepa-mercapturate.
English: Cardiac disorders
Maltese: Insuffiċjenza kardijaka
English: 4.5 Interactions with other medicinal products and other forms of interaction
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni
English: The identified metabolites TEPA, monochlorotepa and thiotepa-mercapturate are all excreted in the urine.
Maltese: Il-metaboliti identifikati TEPA, monochlorotepa u thiotepa-mercapturate kollha jitneħħew fl-awrina.
English: Regimen Related Mortality (RRM) and Transplant Related Mortality (TRM): RRM values ranging from 2.5% to 29% have been reported.
Maltese: Mortalità Relatata mal-Kors (Regimen Related Mortality - RRM) u Mortalità Relatata mat-Trapjant (Transplant Related Mortality - TRM) : ġew irrappurtati valuri ta' RRM li jvarjaw minn 2.5% sa 29%.
English: REFRACTORY CYTOPENIA
Maltese: ĊITOPENIJA REFRATTORJA
English: Chemical and physical in-use stability after reconstitution has been demonstrated for 8 hours when stored at 2°C-8°C.
Maltese: Intweriet stabilità kimika u fiżika waqt l-użu wara r-rikostituzzjoni għal 8 sigħat meta jinżamm maħżun f'temperatura ta' 2°C-8 °C.
English: Posology in adults
Maltese: Il-pożoloġija fl-adulti
English: For instructions on reconstitution and further dilution prior to administration, see section 6.6.
Maltese: Għal istruzzjonijiet dwar ir-rikostituzzjoni u d-dilwizzjoni ulterjuri qabel ma jingħata, ara sezzjoni 6.6.
English: Regimen Related Mortality (RRM) and Transplant Related Mortality (TRM): RRM values ranging from 0% to 26.7% have been reported.
Maltese: Mortalità Relatata mal-Kors (RRM) u Mortalità Relatata mat-Trapjant (TRM): ġew irrappurtati valuri ta' RRM li jvarjaw minn 0% sa 26.
English: Investigation
Maltese: Investigazzjoni
English: - inflammation and exfoliation of the skin (erythrodermic psoriasis) - delirium, nervousness, hallucination, agitation - gastrointestinal ulcer - inflammation of the muscular tissue of the heart (myocarditis) - abnormal heart condition (cardiomyopathy)
Maltese: - ulċera gastro-intestinali - infjammazzjoni fit-tessut muskulari tal-qalb (mijokardite) - kundizzjoni mhux normali tal-qalb (kardjomijopatija)
English: Accord Healthcare B.V. Tel: +31 30 850 6014
Maltese: Tel: +31 30 850 6014
English: Relapse: In all the reported conditioning regimens containing thiotepa, the relapse rate was in the range of 15% - 44%.
Maltese: Fil-korsijiet ta' kondizzjonament kollha rrappurtati li fihom thiotepa, ir-rata ta' rikaduta kienet bejn il-15% - 44%.
English: Disease Free Survival (DFS): An estimated 43% at five years has been reported, confirming that conditioning treatments containing thiotepa following autologous HPCT are effective therapeutic strategies for treating patients with haematological diseases.
Maltese: Sopravvivenza Mingħajr Mard (Disease Free Survival - DFS): ġie rrappurtat għal madwar 43% wara ħames snin, li jikkonferma li l-kuri ta' kondizzjonament li fihom thiotepa wara HPCT awtologu huma strateġiji terapewtiċi effettivi għall-kura ta' pazjenti b'mard ematoloġiku.
English: TEPADINA must be delivered after the completion of any cyclophosphamide infusion (see section 4.5).
Maltese: TEPADINA għandu jingħata wara li titlesta kwalunkwe infużjoni b'cyclophosphamide (ara sezzjoni 4.5).
English: Hepatic impairment The effects of hepatic impairment on thiotepa metabolism and elimination have not been assessed.
Maltese: L-effetti tan-nuqqas ta' funzjoni epatika fuq il-metaboliżmu u l-eliminazzjoni ta' thiotepa ma ġewx evalwati.
English: Engraftment: It has been achieved with all evaluated conditioning regimens including thiotepa with a success rate of 96% - 100%.
Maltese: Dan inkiseb bil-korsijiet ta' kondizzjonament kollha evalwati li jinkludu thiotepa b'rata ta' suċċess ta' 96% - 100%.
English: During the concomitant use of thiotepa and inhibitors of CYP2B6 or CYP3A4, patients should be carefully monitored clinically (see section 4.5).
Maltese: Waqt l-użu konkomitanti ta' thiotepa u inibituri ta' CYP2B6 jew CYP3A4, il-pazjenti għandhom ikunu mmonitorjati b'attenzjoni klinikament (ara sezzjoni 4.5).
English: The volume of distribution of thiotepa is large and it has been reported as ranging from 40.8 l/m2 to 75 l/m2, indicating distribution to total body water.
Maltese: Il-volum ta' distribuzzjoni ta' thiotepa huwa kbira u ġie rrappurtat li jvarja minn 40.8 l/m2 sa 75 l/m2,
English: Type I clear glass vial with a rubber stopper (bromobutyl or chlorobutyl), containing 15 mg thiotepa.
Maltese: Kunjett tal-ħġieġ ċar tat-Tip I b'tapp tal-lasktu (bromobutyl jew chlorobutyl), li fih 15 mg thiotepa.
English: Regimen Related Mortality (RRM) and Transplant Related Mortality (TRM): RRM values ranging from 0% to 2% have been reported.
Maltese: Mortalità Relatata mal-Kors (RRM) u Mortalità Relatata mat-Trapjant (TRM): ġew irrappurtati valuri ta' RRM li jvarjaw minn 0% sa 2%.
English: Uncommon side effects (may affect up to 1 in 100 people) - inflammation and exfoliation of the skin (erythrodermic psoriasis) - delirium, nervousness, hallucination, agitation - gastrointestinal ulcer - inflammation of the muscular tissue of the heart (myocarditis) - abnormal heart condition (cardiomyopathy)
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa 1 minn kull 100 persuna) - infjammazzjoni u tqaxxir tal-ġilda (psorjasi eritrodermika) - thewdin, nervożiżmu, alluċinazzjoni, aġitazzjoni
English: (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: (8.10 mg/kg/jum) bħala infużjoni waħda kuljum, li tingħata minn 2 sa 4 t'ijiem konsekuttivi qabel lHPCT awtologu skont il-kombinazzjoni ma' prodotti mediċinali kemoterapewtiċikemoterapewtiċi oħrajn, mingħajr ma tinqabeż id-doża kumulattiva massima totali ta' 900 mg/m2 (24.32 mg/kg), matul il-perijodu kollu ta' kura ta' kondizzjonament.
English: After intravenous administration, CSF medicinal product exposure is nearly equivalent to that achieved in plasma; the mean ratio of AUC in CSF to plasma for thiotepa is 0.93.
Maltese: Wara l-għoti minn ġol-vini, l-espożizzjoni CSF għall-prodott mediċinali hija kważi ekwivalenti għal dik miksuba fil-plażma; il-proporzjon medju ta' AUC fis-CSF għall-plażma għal thiotepa huwa 0.93.
English: Stomatitis Oesophagitis Vomiting Diarrhoea Dyspepsia Abdominal pain Enteritis Colitis
Maltese: Thiotepa għandu l-ablazzjoni tal-mudullun bħala t-tossiċità li tillimita d-doża, li tippermetti żieda sinifikanti fid-doża bl-infużjoni ta' HPCT awtologu.
English: Ataxia
Maltese: Ipoksja
English: Relapse: In all the reported conditioning regimens containing thiotepa, relapse rates at 12 to 57 months ranged from 33% to 57%.
Maltese: Fil-korsijiet ta' kondizzjonament kollha rrappurtati li fihom thiotepa, ir-rati ta' rikaduta minn 12 sa 57 xahar kienu jvarjaw minn 33% sa 57%.
English: The reconstituted solution is hypotonic and must be further diluted prior to administration with 500 ml sodium chloride 9 mg/ml (0.9%) solution for injection (1000 ml if the dose is higher than 500 mg) or with an appropriate volume of sodium chloride 9 mg/ml (0.9%) in order to obtain a final TEPADINA concentration between 0.5 and 1 mg/ml.
Maltese: Is-soluzzjoni rikostitwita hija ipotonika u għandha tiġi dilwita aktar qabel ma tingħata b'soluzzjoni għall-injezzjoni ta' 500 ml ta' 9 mg/ml (0.9%) sodium chloride (1000 ml kemm-il darba d-doża hi ogħla minn 500 mg) jew b'volum xieraq ta' 9 mg/ml (0.9%) soluzzjoni ta' sodium chloride għallinjezzjoni sabiex tinkiseb konċentrazzjoni finali ta' TEPADINA ta' bejn 0.5 u 1 mg/ml.
English: Regimen Related Mortality (RRM) and Transplant Related Mortality (TRM): low values have been reported, confirming the safety of the conditioning treatments including thiotepa for allogeneic HPCT in adult patients with haematological diseases.
Maltese: Mortalità Relatata mal-Kors (RRM) u Mortalità Relatata mat-Trapjant (TRM): ġew irrappurtati valuri baxxi, li jikkonferma s-sigurtà tal-kuri ta' kondizzjonament li jinkludu thiotepa għal HPCT alloġeneiku f'pazjenti adulti b'mard ematoloġiku.
English: Toxic shock syndrome
Maltese: Sindromu ta' xokk tossiku
English: Idiopathic pneumonia syndrome Epistaxis
Maltese: Sindromu ta' pnewmonja idjopatika Epistassi
English: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Maltese: Neoplażmi beninni, malinni u mhux speċifikati (inklużi ċesti u polipi)
English: TEPADINA must be administered by a qualified healthcare professional as a 2-4 hours intravenous infusion via a central venous catheter.
Maltese: TEPADINA għandu jingħata minn professjonist ikkwalifikat fil-kura tas-saħħa bħala infużjoni ġolvini ta' 2-4 sigħat permezz ta' kateter venuż ċentrali.
English: THALASSEMIA
Maltese: TALASSEMIJA
English: Arrhythmia
Maltese: PREŻENTAZZJONI
English: Immedica Pharma AB Tlf: +46 (0)8 533 39 500
Maltese: Tlf: +46 (0)8 533 39 500
English: Cataract
Maltese: Takikardija
English: There is no known antidote for thiotepa.
Maltese: kondizzjonament ibbażati fuq thiotepa.
English: Dose modification is not recommended for transient alterations of hepatic parameters (see section 4.4).
Maltese: It-tibdil fid-doża mhuwiex rakkomandat għal alterazzjonijiet temporanji ta' parametri epatiċi (ara sezzjoni 4.4).
English: • with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients;
Maltese: • bi u mingħajr irradjazzjoni totali tal-ġisem (TBI), bħala trattament ta' kondizzjonament qabel ittrapjant alloġeneiku jew awtologu taċ-ċelluli ematopojetiċi proġenitriċi (haematopoietic progenitor cell transplantation - HPCT) f'mard ematoloġiku fl-adulti u fil-pazjenti pedjatriċi;
English: In these studies, a total of 6,588 adult patients and 902 paediatric patients received thiotepa for conditioning treatment prior to haematopoietic progenitor cell transplantation.
Maltese: F'dawn l-istudji, total ta' 6588 pazjent adult u 902 pazjenti pedjatriċi irċevew thiotepa għall-kura ta' kondizzjonament qabel it-trapjant taċ-ċelloli ematopojetiċi proġenitriċi.
English: Venoocclusive liver disease Hepatomegaly Jaundice
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Constipation Gastrointestinal perforation Ileus
Maltese: Stitikezza Perforazzjoni gastro-intestinali
English: Cytotoxic.
Maltese: Ċitotossiku.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il portal elettroniku Ewropew tal-mediċini.
English: As most alkylating agents, thiotepa might impair male or female fertility.
Maltese: Bħall-parti l-kbira tas-sustanzi alkilanti, thiotepa jista' jfixkel il-fertilità maskili jew femminili.
English: - increased susceptibility to infection - whole-body inflammatory state (sepsis) - decreased counts of white blood cells, platelets and red blood cells (anaemia) - the transplanted cells attack your body (graft versus host disease) - dizziness, headache, blurred vision - uncontrolled shaking of the body (convulsion) - sensation of tingling, pricking or numbness (paraesthesia) - partial loss of movement - cardiac arrest - nausea, vomiting, diarrhoea - inflammation of the mucosa of the mouth (mucositis) - irritated stomach, gullet, intestine - inflammation of the colon - anorexia, decreased appetite - high glucose in the blood - skin rash, itching, shedding - skin colour disorder (do not confuse with jaundice - see below) - redness of the skin (erythema) - hair loss - back and abdominal pain, pain - muscle and joint pain - abnormal electrical activity in the heart (arrhythmia) - inflammation of lung tissue - enlarged liver - altered organ function - blocking of a liver vein (Veno-Occlusive Disease, VOD) - yellowing of the skin and eyes (jaundice) - hearing impaired - lymphatic obstruction - high blood pressure - increased liver, renal and digestive enzymes - abnormal blood electrolytes - weight gain - fever, general weakness, chills - bleeding (haemorrhage) - nasal bleeding - general swelling due to fluid retention (oedema) - pain or inflammation at the injection site - eye infection (conjunctivitis) - decreased sperm cell count - vaginal bleeding - absence of menstrual periods (amenorrhea) - memory loss - delaying in weight and height increase - bladder disfunction - underproduction of testosterone - insufficient production of thyroid hormone - deficient activity of the pituitary gland - confusional state
Maltese: - tnaqqis fl-għadd ta' ċelloli bojod tad-demm, plejtlits u ċelloli ħomor tad-demm (anemija) - iċ-ċelloli trapjantati jattakkaw il-ġisem tiegħek (graft versus host disease) - sturdament, uġigħ ta' ras, vista mċajpra - tregħid mhux ikkontrollat tal-ġisem (konvulżjoni) - sensazzjoni ta' tnemnim, tingiż jew tirżiħ (parasteżija)
English: The recommended dose ranges from 200 mg/m2/day (8 mg/kg/day) to 250 mg/m2/day (10 mg/kg/day) divided in two daily infusions, administered before allogeneic HPCT without exceeding the total maximum cumulative dose of 250 mg/m2 (10 mg/kg), during the time of the entire conditioning treatment.
Maltese: Id-doża rakkomandata tvarja minn 200 mg/m2/ġurnata (8 mg/kg/ġurnata) sa 250 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' 250 mg/m2 (10 mg/kg), matul il-perjodu tat trattament sħiħ ta' kundizzjonament.
English: After reconstitution with 10 ml of water for injections, each ml of solution contains 10 mg thiotepa (10 mg/ml).
Maltese: Wara r-rikostituzzjoni ma' 10 ml ilma għall-injezzjonijiet, kull ml tas-soluzzjoni fih 10 mg thiotepa (10 mg/ml).
English: TEPADINA is a white crystalline powder supplied in a glass vial containing 100 mg thiotepa.
Maltese: TEPADINA huwa trab kristallin abjad li jiġi f'kunjett tal-ħġieġ li fih 100 mg thiotepa.
English: Transaminases increased
Maltese: Transaminases
English: Erythema Desquamation Pigmentation disorder
Maltese: Distrubi filpigmentazzjoni Psorjasi eritrodermika
English: After reconstitution with 1.5 ml of water for injections, each ml of solution contains 10 mg thiotepa (10 mg/ml).
Maltese: Wara r-rikostituzzjoni ma' 1.5 ml ilma għall-injezzjonijiet, kull ml tas-soluzzjoni fih 10 mg thiotepa (10 mg/ml).
English: Using a syringe fitted with a needle, aseptically withdraw 10 ml of sterile water for injection.
Maltese: TEPADINA għandha tiġi rikostitwita b' 10 ml ilma sterili għall-injezzjonijiet.
English: Allogeneic HPCT
Maltese: HPCT awtologu
English: Type I clear glass vial with a rubber stopper (bromobutyl or buthyl), containing 100 mg thiotepa.
Maltese: Kunjett tal-ħġieġ ċar tat-Tip I b'tapp tal-lasktu (bromobutyl jew butyl), li fih 100 mg thiotepa.
English: Metabolism and nutrition disorders Anorexia Hyperglycaemia
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Anoressja
English: Gammaglutamyltransferase increased
Maltese: Żieda fil-gamma glutamyltransferas e