FrancophonIA/ELRC3.0 huggingface dataset:
English: WBC counts during consolidation were not as high as during induction treatment and were < 10 x 103/μl, except in one patient who had a WBC count of 22 x 103/μl during consolidation.
Maltese: L-għadd tal-WBC matul il-konsolidazzjoni ma kinux għoljin daqshekk matul it-trattament tal-induzzjoni u kienu < 10 x 103/μL, barra fil-każ ta' pazjent wieħed li kellu għadd ta' WBC ta' 22 x 103/μL matul ilkonsolidazzjoni.
English: The safety and efficacy of Arsenic trioxide in children aged up to 17 years has not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Arsenic trioxide fit-tfal ta' età sa 17-il sena għadhom ma ġewx determinati s'issa.
English: In one newly diagnosed patient induction treatment was terminated because of severe prolongation of the QTc interval and electrolyte abnormalities on day 3 of induction treatment.
Maltese: F'pazjent wieħed it-trattament ta' induzzjoni twaqqaf minħabba titwil sever talintervall QTc u anormalitajiet tal-elettroliti f'jum 3.
English: Concentrate for solution for infusion Sterile, clear, colourless, aqueous solution, free from particles having a pH range of 7.7 - 8.3.
Maltese: Soluzzjoni sterili, ċara, bla kulur, milwima, mingħajr frak li għandha medda ta' pH ta' 7.7 - 8.3.
English: The arsenic in Arsenic trioxide Accord passes into breast milk.
Maltese: Arsenic trioxide Accord irid jiġi dilwit qabel ma jingħata.
English: In the presence of coagulopathy, the oral administration of the chelating agent dimercaptosuccinic acid succimer (DCI) 10 mg/kg or 350 mg/m2 every 8 hours during 5 days and then every 12 hours during 2 weeks is recommended.
Maltese: Meta jkun hemm kojagulopatija, l-għoti mill-ħalq ta' aġent ta' kelazzjoni dimercaptosuccinic acid succimer (DCI) 10 mg/kg jew 350 mg/m2 kull 8 sigħat matul 5 ijiem u imbagħad kull 12-il siegħa matul 2 ġimgħat hu rrakkomandat.
English: In newly diagnosed patients with low to intermediate risk APL 63.2 % developed grade 3 or 4 hepatic toxic effects during induction or consolidation treatment with arsenic trioxide in combination with ATRA (see section 4.8).
Maltese: F'pazjenti ddijanjostikati għall-ewwel darba b'APL ta' riskju baxx sa intermedju, 63.2 % żviluppaw effetti ta' tossiċità epatika ta' grad 3 jew 4 matul it-trattament ta' induzzjoni jew konsolidazzjoni b' arsenic trioxide flimkien ma' ATRA (ara sezzjoni 4.8).
English: Not known (frequency cannot be estimated from the available data): - lung infection, infection in the blood - inflammation of the lungs which causes chest pain and breathlessness, cardiac failure - dehydration, confusion
Maltese: Mhux magħruf (ma tistax tittieħed stima mid-data disponibbli): - infezzjoni fil-pulmun, infezzjoni fid-demm - infjammazzjoni tal-pulmun li tikkawża wġigħ fis-sider u qtugħ ta' nifs, insuffiċjenza kardijaka - deidratazzjoni (nixfa), konfużjoni
English: Arsenic trioxide is indicated for induction of remission, and consolidation in adult patients with:
Maltese: Arsenic trioxide hu indikat għall-induzzjoni tar-remissjoni, u l-konsolidazzjoni f'pazjent adulti li jbatu minn:
English: Very common (may affect more than 1 in 10 people): - fatigue (weariness), pain, fever, headache - nausea, vomiting, diarrhoea - dizziness, muscle pain, numbness or tingling - rash or itching, increased blood sugar, oedema (swelling due to excess fluid) - shortness of breath, fast heart beat, abnormal ECG heart tracing - reduced potassium or magnesium in the blood, liver function tests abnormal including presence of excess bilirubin or gamma-glutamyltransferase in the blood
Maltese: Komuni ħafna (jistgħu jaffettwaw lil iktar minn persuna 1 minn kull 10): - għeja kbira, uġigħ, deni, uġigħ ta' ras - nawseja, rimettar, dijarea - sturdament, uġigħ fil-muskoli, tmewwit jew tnemnim - raxx jew ħakk, żieda fil-livell ta' zokkor fid-demm, edema (nefħa minħabba ammont eċċessiv ta' fluwidu), - qtugħ ta' nifs, rata mgħaġla ta' taħbit tal-qalb, intraċċar anormali ta' ECG tal-qalb - tnaqqas fil-livell tal-potassium jew magnesium fid-demm, testijiet tal-funzjoni tal-fwied li jagħtu riżultat mhux normali li jinkludu l-preżenza ta' bilirubina jew gamma glutamyltransferase żejda fid-demm
English: Relapsed/refractory APL
Maltese: APL li tirkadi/refrattarja
English: In newly diagnosed patients with low to intermediate risk APL 63.2 % developed grade 3 or 4 hepatic toxic effects during induction or consolidation treatment with arsenic trioxide in combination with ATRA.
Maltese: F'pazjenti ddijanjostikati għall-ewwel darba, b'APL ta' riskju baxx sa intermedju 63.2% żviluppaw effetti ta' tossiċità epatika ta' grad 3 jew 4 matul it-trattament ta' induzzjoni jew konsolidazzjoni b'arsenic trioxide flimkien ma' ATRA.
English: p = 0.11
Maltese: L01XX27
English: In these studies, leukocytosis was not treated with chemotherapeutic medicinal products.
Maltese: F'dawn l-istudji, il-lewkoċitożi ma kinitx ikkurata permezz ta' prodotti mediċinali kemoterapewtiċi.
English: This syndrome can be fatal.
Maltese: Dan issindrome jista' jkun fatali.
English: One ml of concentrate for solution for infusion contains 1 mg of arsenic trioxide.
Maltese: U KWANTITATTIVA mL wieħed ta' konċentrat għal soluzzjoni għall-infużjoni fih 1 mg ta' arsenic trioxide.
English: Your doctor will take the following precautions: - Tests will be performed to check the amount of potassium, magnesium, calcium and creatinine in your blood before your first dose of Arsenic trioxide Accord.
Maltese: - Se jsiru testijiet biex jiċċekkjaw l-ammont ta' potassium, magnesium, calcium u krejatinina fiddemm tiegħek qabel ma tingħata l-ewwel doża ta' Arsenic trioxide Accord.
English: In order to prevent the development of the APL differentiation syndrome during induction treatment, prednisone (0.5 mg/kg body weight per day throughout induction treatment) may be administered from day 1 of arsenic trioxide application to the end of induction therapy in APL patients.
Maltese: Sabiex jiġi evitat l-iżvilupp tas-sindrome ta' divrenzjar ta' APL matul it-trattament ta' induzzjoni, prednisone (0.5 mg/kg ta' piż tal-ġisem kuljum matul it-trattament ta' induzzjoni) jista' jingħata minn jum 1 tal-applikazzjoni ta' arsenic trioxide sat-tmiem tat-terapija ta' induzzjoni f'pazjenti b'APL.
English: Cytogenetics after arsenic trioxide therapy
Maltese: Mediċini oħra u Arsenic trioxide Accord
English: All grades
Maltese: Remissjoni kompleta
English: The influence of arsenic trioxide on the efficacy of other antileukaemic medicinal products is unknown.
Maltese: L-influwenza ta' arsenic trioxide fuq l-effikaċja ta' prodotti mediċinali oħra antilewkemiċi mhix magħrufa.
English: Medicinal products known to cause hepatotoxic effects Hepatotoxic effects may occur during the treatment with arsenic trioxide, caution is advised when arsenic trioxide is coadministered with other medicinal products known to cause hepatotoxic effects (see section 4.4 and 4.8).
Maltese: Prodotti mediċinali magħrufa li jikkawżaw effetti epatotossiċi Matul it-trattament b'arsenic trioxide jistgħu jseħħu effetti epatotossiċi, attenzjoni hija rakkomandata meta arsenic trioxide jingħata flimkien ma' prodotti mediċinali oħra magħrufa li jikkawżaw effetti epatotossiċi (ara sezzjoni 4.4 u 4.8).
English: Metabolism and nutrition disorders
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Ipergliċemija
English: Hematologic complete remission (HCR)
Maltese: Remissjoni ematoloġika kompleta (HCRHematologic p=0.
English: 1000 mg four times a day
Maltese: 1,000 mg erba' darbiet kuljum
English: How to store Arsenic trioxide Accord Contents of the pack and other information
Maltese: Kif taħżen Arsenic trioxide Accord Kontenut tal-pakkett u informazzjoni oħra
English: In newly diagnosed APL patients treated with arsenic trioxide and ATRA, APL differentiation syndrome was observed in 19 % including 5 severe cases.
Maltese: F'pazjenti b'APL iddijanjostikata għall-ewwel darba ttrattati b'ATRA, ġie osservat sindrome ta' divrenzjar ta' APL fi 19 % inklużi 5 każijiet severi.
English: Clinically unstable APL patients are especially at risk and will require more frequent monitoring of electrolyte and glycaemia levels as well as more frequent haematologic, hepatic, renal and coagulation parameter tests.
Maltese: Pazjenti APL li mhumiex klinikalment stabbli huma aktar u aktar fir-riskju u ser ikollhom bżonn ta' monitoraġġ ta' spiss tal-livelli ta' elettroliti u tal-gliċemija u testijiet ta' spiss tal-paremetri ematoloġiċi, epatiċi, renali u ta' koagulazzjoni.
English: However, toxic effects resolved with temporary discontinuation of either arsenic trioxide, ATRA or both (see section 4.4).
Maltese: Madankollu, l-effetti tossiċi għaddew permezz ta' twaqqif temporanju ta' arsenic trioxide, ATRA jew it-tnejn li huma (ara sezzjoni 4.4).
English: Induction treatment schedule
Maltese: TAL-PRODOTT MEDIĊINALI
English: Dilution of Arsenic trioxide Accord
Maltese: Dilwizzjoni ta' Arsenic trioxide Accord
English: Patients with hepatic impairment Since no data are available across all hepatic impairment groups and hepatotoxic effects may occur during the treatment with arsenic trioxide caution is advised in the use of arsenic trioxide in patients with hepatic impairment (see section 4.4 on hepatotoxicity and section 4.8).
Maltese: Peress li ma hemmx tagħrif disponibbli tul il-gruppi kollha ta' indeboliment epatiku u jistgħu jseħħu effetti epatotossiċi matul it-trattament b'arsenic trioxide, attenzjoni hija rakkomandata fl-użu ta' arsenic trioxide f'pazjenti b'indeboliment epatiku (ara sezzjoni 4.4 dwar l-epatotossiċità u sezzjoni 4.8).
English: Three patients from the single institution study and 15 patients from the multicentre study had stem cell transplants after completing arsenic trioxide.
Maltese: Tlett pazjenti millistudju ta' istituzzjoni unika u 15-il pazjent mill-istudju multiċentriku ngħataw trapjanti ta' ċelluli staminali wara t-tmiem ta' arsenic trioxide.
English: Your doctor will decide exactly how long you must continue on therapy with Arsenic trioxide Accord.
Maltese: It-tabib tiegħek ser jiddeċiedi eżattament kemm għandek tkompli tingħata t-terapija Arsenic trioxide Accord.
English: If complete remission has not occurred by day 50, dosing must be discontinued.
Maltese: Jekk ma jkun hemm l-ebda remissjoni kompleta saljum 50, id-dożaġġ għandu jitwaqqaf.
English: Procedure for proper disposal
Maltese: complete remission)
English: Treatment with arsenic trioxide must be discontinued before the scheduled end of therapy at any time that a hepatotoxicity grade 3 or greater on the National Cancer Institute Common Toxicity Criteria is observed.
Maltese: It-trattament b'arsenic trioxide għandu jitwaqqaf qabel it-tmiem skedat tat-terapija kull meta tiġi osservata epatotossiċità ta' grad 3 jew akbar fuq il-Kriterji ta' Tossiċità Komuni tal-Istitut Nazzjonali tal-Kanċer.
English: Treatment with arsenic trioxide must be temporarily interrupted before the scheduled end of therapy at any time that a toxicity grade 3 or greater on the National Cancer Institute Common Toxicity Criteria is observed and judged to be possibly related to Arsenic trioxide treatment.
Maltese: It-trattament b'arsenic trioxide għandu jkun interrott temporanjament qabel it-tmiem skedat tat-terapija fi kwalunkwe ħin meta t-tossiċità grad 3 jew ogħla skont il-Kriterji tat-Tossiċità Komuni tal-Istitut Nazzjonali tal-Kanċer tkun innotata u meqjusa li hi probabbli marbuta mat-trattament b'Arsenic trioxide.
English: If your disease responds to Arsenic trioxide Accord, you will be given 4 additional treatment cycles of 20 doses given 5 days per week (followed by 2 days interruption) for 4 weeks followed by 4 weeks interruption.
Maltese: Jekk il-marda tiegħek tirrispondi għal Arsenic trioxide Accord, int ser tingħata 4 ċikli ta' trattament addizzjonali ta' 20 doża mogħtija 5 ijiem kull ġimgħa (segwiti minn jumejn ta' interuzzjoni) għal 4 ġimgħat segwiti minn 4 ġimgħat ta' interruzzjoni.
English: is large (>400 L) indicating significant distribution into the tissues with negligible protein binding.
Maltese: Il-volum ta' distribuzzjoni (Vd) għal AsIII huwa kbir (>400 L) u dan jindika distribuzzjoni sinifikanti ġewwa t-tessuti bi twaħħil negliġibbli mal-proteini.
English: Arsenic trioxide Accord must be diluted with a solution containing glucose or a solution containing sodium chloride.
Maltese: Arsenic trioxide Accord irid jiġi dilwit b'soluzzjoni li jkun fiha glucose jew soluzzjoni li jkun fiha sodium chloride.
English: Caution is advised when arsenic trioxide is coadministered with other medicinal products known to cause QT/QTc interval prolongation such as macrolide antibiotics, the antipsychotic thioridazine, or medicinal products known to cause hypokalemia or hypomagnesaemia.
Maltese: Wieħed irid joqgħod attent meta arsenic trioxide jingħata flimkien ma' prodotti mediċinali oħra li huma magħrufa li jikkawżaw titwil tal-intervall Qt/QTc bħal ngħidu aħna antibijotiċi makrolidi, l-antipsychotic thioridazine, jew prodotti mediċinali magħrufa li jikkawżaw ipokalimja jew ipomanjesimja.
English: Hypermagnesaemia
Maltese: Edema tal-wiċċ
English: No clear trend toward an increase in systemic exposure to AsIII, AsV, MMAV or DMAV was observed with decreasing level of hepatic function as assessed by dose-normalized (per mg dose) AUC.
Maltese: Ma kienet osservata l-ebda tendenza ċara lejn żieda fl-esponiment sistemiku għal AsIII, AsV, MMAV jew DMAV bi tnaqqis fil-livell ta' funzjoni epatika kif stmat mill-AUC ta' doża normalizzata (kull mg ta' doża).
English: Complete remission (CR) was defined as the absence of visible leukaemic cells in the bone marrow and peripheral recovery of platelets and white blood cells.
Maltese: Remissjoni kompleta (RK) kienet definita bħala n-nuqqas ta' ċelluli lewkemiċi viżibbli fil-mudullun tal-għadma u rkupru periferali tal-plejtlits u lewkoċiti.
English: Arsenic trioxide is to be administered intravenously at a dose of 0.15 mg/kg/day for 25 doses given 5 days per week, followed by 2 days interruption, repeated for 5 weeks.
Maltese: Arsenic trioxide għandu jingħata ġol-vina b'doża ta' 0.15 mg/kg/kuljum għal 25 doża mogħtija matul 5 ġranet kull ġimgħa, segwiti minn waqfien ta' 2 ġranet, u ripetuti għal 5 ġimgħat.
English: One patient treated under a compassionate use program died from cerebral infarct due to leukocytosis, following treatment with chemotherapeutic medicinal products to lower WBC count.
Maltese: Pazjent wieħed li kien ikkurat skont programm tal-użu b'kompassjoni miet b'infart ċerebrali minħabba l-lewkoċitożi wara t-trattament bil-prodotti mediċinali kemoterapewtiċi biex ibaxxu l-għadd WBC.
English: At the first signs that could suggest the syndrome (unexplained fever, dyspnoea and/or weight gain, abnormal chest auscultatory findings or radiographic abnormalities), treatment with arsenic trioxide must be temporarily discontinued and high-dose steroids (dexamethasone 10 mg intravenously twice a day) must be immediately initiated, irrespective of the leukocyte count and continued for at least 3 days or longer until signs and symptoms have abated.
Maltese: Malli jidhru l-ewwel sinjali li jistgħu jissuġġerixxu s-sindrome (deni, qtugħ ta' nifs u/jew żieda fil-piż, każi awskultatori abnormali fis-sider jew abnormalitajiet radjugrafiċi mingħajr spjegazzjoni), it-trattament b'arsenic trioxide għandu jitwaqqaf temporanjament u għandhom jingħataw minnufih dożi għoljin ta' sterojdi (10 mg ta' dexamethasone ġol-vina darbtejn kuljum) hu x'inhu l-għadd tal-lewkoċiti u jitkomplew sa tal-anqas 3 ijiem jew aktar sakemm is-sinjali u sintomi jonqsu.
English: CTC grade 3-4
Maltese: CTC grad 3-4
English: B-1420 Braine-L'Alleud Belgium
Maltese: B-1420 Braine-L'Alleud Il-Belġju
English: Potassium 98 mg/500 ml or 5.0 mmol/l Sodium 1.61 g/500 ml or 140 mmol/l
Maltese: Potassju 98 mg/500 ml jew 5.0 mmol/l Sodju 1.61 g/500 ml jew 140 mmol/l
English: The apparent volumes of distribution are 0.13-1.3 l/kg (median 0.49 l/kg).
Maltese: Il-volumi evidenti taddistribuzzjoni huma 0.13-1.3 l/kg (punt medjan 0.49 l/kg).
English: Clear isotonic solution (295 mOsml/l, pH approx. 7.4).
Maltese: Soluzzjoni isotonika ċara (295 mOsml/l, pH ta' madwar 7.4).
English: PHARMACEUTICAL FORM AND CONTENTS 500 ml solvent
Maltese: 500 ml solvent
English: Date of latest renewal: 18 July 2011
Maltese: Data tal-aħħar tiġdid: 18 ta' Lulju 2011
English: Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000)
Maltese: Mhux komuni (≥1/1,000 sa <1/100) Rari (≥1/10,000 sa <1/1,000)
English: The terminal elimination half-life was consistent throughout days 1 - 3 (2.1 - 2.2 h).
Maltese: Il-half life taleliminazzjoni finali kienet konsistenti matul jiem 1 - 3 (2.1 - 2.2 s).
English: Calcium Total (Hypo)
Maltese: Calcium Totali (Aktar baxx)
English: Sodium (Hypo) Potassium (Hypo) Potassium (Hyper) Alkaline Phosphatase Bilirubin
Maltese: Sodium (Aktar baxx) Potassium (Aktar baxx) Potassium (Aktar għoli) Alkaline Phosphatase Bilirubin
English: Incidence of laboratory abnormalities in TT01 and TT02 (n=80 patients) Lab test
Maltese: Inċidenza ta' anormalitajiet tal-laboratorju fit-TT01 u TT02 (n=80 pazjent) Test tal-laboratorju
English: No of patients with post baseline value
Maltese: Nru ta' pazjenti b'valur post baseline
English: The steady-state volume of distribution of dexrazoxane was 30.5 L ± 11.1 for day 1 and 35.8 L ± 19.7 for day 2.
Maltese: Il-volum ta' distribuzzjoni fi stat fiss ta' dexrazoxane kien ta' 30.5 L ± 11.1 għal jum 1 u ta' 35.8 L ± 19.7 għal jum 2.
English: Interaction specific to dexrazoxane:
Maltese: Interazzjoni speċifika għal dexrazoxane:
English: Total urinary recovery of unchanged dexrazoxane is 34-60 %.
Maltese: L-irkupru totali fl-awrina ta' dexrazoxane mhux mibdul huwa 34-60 %.
English: The recommended adult dose (with normal kidney function) is:
Maltese: Id-doża rakkomandata għall-adulti (b'funzjoni tal-kliewi normali) hija:
English: Day 3: 500 mg/m2
Maltese: Ġurnata 3: 500 mg/m2
English: • Reduction in any of your senses (sight, smell, hearing, touch, taste)
Maltese: • Tnaqqis f'xi wieħed mis-sensi tiegħek (vista, xamm, smigħ, mess, togħma)
English: • Pneumonia (lung infection)
Maltese: • Pnewmonja (infezzjoni fil-pulmun)
English: The systemic clearances were similar between day 1 (9.9 L/h ± 3.1) and day 2 (11.1 L/h ± 4.5), and did not differ from those reported in the literature.
Maltese: It-tneħħijiet sistemiċi kienu simili bejn jum 1 (9.9 L/s ± 3.1) u jum 2 (11.1 L/s ± 4.5), u ma kinux differenti minn dawk irrappurtati fil-letteratura.
English: Pack sizes:
Maltese: Tużax Savene:
English: • Other live attenuated vaccines: risk of systemic, possible fatal disease.
Maltese: • Vaċċini attenwati ħajjin oħra: riskju ta' mard sistemiku, possibbilment fatali.
English: It contains no antibacterial preservative.
Maltese: Ma fiha ebda preservattiv antibatteriku.
English: Anaphylactic reaction including angioedema, skin reactions, bronchospasm, respiratory distress, hypotension and loss of consciousness have been observed in patients treated with dexrazoxane and anthracyclines (see section 4.8).
Maltese: Reazzjoni anafilattika inkluż anġjoedema, reazzjonijiet tal-ġilda, bronkospażmi, diffikultajiet respiratorji, pressjoni baxxa u telfien tas-sensi ġew osservati f'pazjenti kkurati b'dexrazoxane u b'anthracyclines (ara sezzjoni 4.8).
English: When tested in five major cytochrome P450 isoenzymes CYP1A, CYP2C9, CYP2C19, CYP2D6 and CYP3A4, none of these were inhibited by dexrazoxane.
Maltese: Meta ttestjat f'ħames isoenżimi cytochrome P459 prinċipali: CYP1A, CYP2C9, CYP2C19, CYP2D6 u CYP3A4, l-ebda wieħed minnhom ma ġie impedut minn dexrazoxane.
English: AUCs were dose-proportional.
Maltese: L-AUCs kienu proporzjonali mad-doża.
English: NN: {number} [national reimbursement number or other national number identifying the medicinal product]>
Maltese: {numru} [numru tar-rimborż nazzjonali jew numru nazzjonali tal-identifikazzjoni ieħor għallprodott mediċinali]>
English: ADR-925 is reported to increase three-fold within 15 min after infusion of 1500 mg/m2 and remain relatively constant on a plateau for 4 hours and then decreased to about half at 24 hours.
Maltese: ADR-925 huwa rrapportat li jiżdied bi tliet darbiet sa 15-il minuta wara infużjoni ta' 1500 mg/m2 u jibqa' relattivament stabbli mingħajr ma jinbidel għal 4 sigħat u mbagħad jonqos għal madwar in-nofs wara 24 siegħa.
English: Day 1: 1000 mg/m2 Day 2: 1000 mg/m2 Day 3: 500 mg/m2
Maltese: Ġurnata 1: 1000 mg/m2 Ġurnata 2: 1000 mg/m2 Ġurnata 3: 500 mg/m2
English: The toxicity in combination with doxorubicin was additive and not synergistic.
Maltese: It-tossiċità flimkien ma' doxorubicin kienet additiva u mhux sinerġetika.
English: Creatinine
Maltese: Krejatinina
English: Initial elimination half lives (alpha) are 0.18-1 h (median 0.34 h) and terminal elimination half lives 1.9-9.1 h (median 2.8 h).
Maltese: Il-half lives inizjali ta' l-eliminazzjoni (alfa) huma 0.18-1 siegħa (punt medjan 0.34 siegħa) u l-half lives finali tat-tneħħija 1.9-9.1 sigħat
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28 July 2006
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 28 ta' Lulju 2006
English: Co-administration of doxorubicin (50 to 60 mg/m2) or epirubicin (60 to 100 mg/m2) did not affect dexrazoxane pharmacokinetics significantly.
Maltese: L-għoti flimkien ta' doxorubicin (50 sa 60 mg/m2) jew ta' epirubicin (60 sa 100 mg/m2) ma affettwax il-farmakokinetika ta' dexrazoxane b'mod sinifikanti.
English: About 2% of dexrazoxane is protein-bound.
Maltese: Madwar 2 % ta' dexrazoxane huwa marbut mal-proteini.
English: What Savene contains - The active substance is dexrazoxane.
Maltese: X'fih Savene - Is-sustanza attiva hija dexrazoxane.
English: Savene powder for concentrate Solvent for Savene
Maltese: Savene trab għal konċentrat Solvent għal Savene
English: Savene solvent contains 98 mg potassium per 500 ml bottle.
Maltese: Is-solvent ta' Savene fih 98 mg potassju f'kull flixkun ta' 500 ml.
English: Savene solvent also contains 1.61 g sodium per 500 ml bottle, equivalent to 81% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Savene solvent fih ukoll 1.61 g sodju f'kull flixkun ta' 500 ml, ekwivalenti għal 81 % tat-teħid massimu rakkomandat ta' kuljum tal-WHO ta' 2 g sodju għal adult.
English: 4.1 Before reconstitution and dilution: - Store below 25 °C.
Maltese: 4.1 Qabel ir-rikostituzzjoni u d-dilwizzjoni: - Aħżen f'temperatura taħt 25 °C.
English: Compared with normal subjects (creatinine clearance (CLCR) >80 mL/min), exposure was 2- fold greater in subjects with moderate (CLCR of 30 to 50 mL/min) to severe (CLCR <30 mL/min) renal impairment.
Maltese: Meta mqabbel ma' pazjenti normali (tneħħija ta' krejatinina (CLCR) >80 mL/min), l-espożizzjoni kienet darbtejn akbar f'pazjenti b'indeboliment renali moderat (CLCR ta' 30 sa 50 mL/min) sa sever (CLCR <30 mL/min).
English: Alopecia Pruritus
Maltese: Alopeċja Prurite
English: Infection Neutropenic infection
Maltese: Infezzjoni Infezzjoni newtropenika
English: The mean elimination half-lives of the one-ring opened metabolite B and metabolite C are 0.9-3.9 h (n=5) and 0.5-0.8 h (n=3),
Maltese: Il-half lives medji tat-tneħħija tal-metabolit b'ċirku wieħed miftuħ B u tal-metabolit Ċ huma 0.9-3.9 sigħat (n=5) u 0.5-0.8 siegħa (n=3), rispettivament.
English: Most common adverse reactions are nausea/vomiting, bone marrow suppression (neutropenia, thrombocytopenia), injection site reactions, diarrhoea, stomatitis and increase in hepatic transaminases (ALT/AST).
Maltese: L-aktar reazzjonijiet avversi komuni huma nnawseja/rimettar, it-trażżin suppressjoni tal-mudullun (newtropenja, tromboċitopenja), reazzjonijiet marbuta mas-sit tal-injezzjoni, dijarea, stomatite u żieda fit-transaminases tal-fwied (ALT/AST).
English: Savene solvent also contains 1.61 g sodium (main component of cooking/table salt) in each 500 ml bottle.
Maltese: Savene solvent fih ukoll 1.61 g sodju (komponent ewlieni tal-melħ tat-tisjir/tal-mejda) f'kull flixkun ta' 500 ml.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/350/001
Maltese: NUMRU TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/06/350/001