FrancophonIA/ELRC3.0 huggingface dataset:
English: Dizziness, somnolence and syncope have been reported in a few patients included in Savene studies TT01 and TT02 (see section 4.8).
Maltese: Sturdamenti, ħedla u sinkope ġew rapportati fi ftit pazjenti li ġew inklużi fl-istudji TT01 u TT02 ta' Savene (ara sezzjoni 4.8).
English: Solvent bottle:
Maltese: Trab u solvent:
English: 3.1 Reconstitution of Savene powder to prepare a concentrate 3.1.1 Using a syringe fitted with a needle, withdraw aseptically 25 ml from the Savene solvent bottle.
Maltese: PREPARAZZJONI GĦALL-GĦOTI ĠOL-VINA 3.1 Rikonstituzzjoni tat-trab Savene sabiex tipprepara l-konċentrat 3.1.1 Permezz ta' siringa mlibbsa bil-labra, islet b'mod asettiku 25 ml mill-flixkun ta' Savene solvent.
English: Marketing Authorisation Holder Clinigen Healthcare B.V.
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq Clinigen Healthcare B.V.
English: • Muscle pain, tremor (uncontrolled muscle movement)
Maltese: • Uġigħ fil-muskoli, rogħda (moviment tal-muskoli mhux ikkontrollat)
English: Modelling suggested that equivalent exposure (AUC0-inf) could be achieved if dosing were reduced by 50% in subjects with CLCR less than 40 mL/min compared with control subjects (CLCR >80 mL/min) (see section 4.2).
Maltese: L-immudellar issuġġerixxa li tista' tinkiseb espożizzjoni ekwivalenti (AUC0-inf) jekk id-dożaġġ jitnaqqas b'50 % f'pazjenti b'CLCR inqas minn 40 mL/min meta mqabbel ma' pazjenti ta' kontroll (CLCR >80 mL/min) (ara sezzjoni 4.2).
English: Clinical trial TT04 was conducted on 6 female patients undergoing treatment for anthracycline extravasations.
Maltese: Il-prova klinika TT04 saret fuq 6 pazjenti nisa li kienu għaddejjin minn trattament għal ekstravazzazzjonijiet ta' anthracycline.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjentielenkati fis-sezzjoni 6.1.
English: Incidence of adverse reactions (MedDRA) in studies TT01 and TT02 (n=80 patients) (Note that numbers for Blood and Lymphatic System Disorders are described in a separate table of laboratory examinations)
Maltese: Inċidenza ta' reazzjonijiet avversi (MedDRA) fl-istudji TT01 u TT02 (n=80 pazjent) (Innota li l-figuri għad-Disturbi tad-Demm u tas-Sistema Limfatika huma deskritti f'tabella separata ta' eżamijiet tal-laboratorju)
English: In patients with moderate to severe renal impairment (creatinine clearance <40 mL/min) the Savene dose should be reduced by 50% (see section 4.4 and 5.2).
Maltese: F'pazjenti b'indeboliment renali moderat sa sever (tneħħija ta' krejatinina <40 mL/min) id-doża ta' Savene għandha titnaqqas b'50 % (ara sezzjoni 4.4 u 5.2).
English: Pharmacotherapeutic group: Detoxifying agents for antineoplastic agents, ATC code: V03AF02
Maltese: Aġenti ta' diżintossifikazzjoni għal aġenti antineoplastiċi, Kodiċi ATC:
English: In-vitro studies on dexrazoxane in human microsomes have shown high stability of dexrazoxane indicating that major metabolism via cytochrome P450 is unlikely.
Maltese: Studji in vitro dwar dexrazoxane meta ttestjat f'mikrosomi umani wrew stabbiltà għolja ta' dexrazoxane li tindika li mhuwiex probabbli metaboliżmu maġġuri permezz taċ-ċitokromu P450.
English: - Ciclosporin or tacrolimus (both treatments lower the body's immune system and are used to prevent organ rejection after an organ transplant).
Maltese: - Ciclosporin jew tacrolimus (iż-żewġ trattamenti jbaxxu s-sistema immunitarja tal-ġisem u jintużaw sabiex jipprevjenu li jkun hemm riġetazzjoni tal-organu wara trapjant ta' organu).
English: Each vial contains 500 mg dexrazoxane (589 mg dexrazoxane hydrochloride).
Maltese: Kull kunjett fih 500 mg dexrazoxane (589 mg dexrazoxane hydrochloride).
English: In study TT01, 23 patients were entered and received treatment with Savene.
Maltese: Fl-istudju TT01 iddaħħlu u ngħataw trattament b'Savene, 23 pazjent.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 500 mg dexrazoxane (589 mg dexrazoxane hydrochloride).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(i) Kull kunjett fih 500 mg dexrazoxane (589 mg bħala dexrazoxane hydrochloride).
English: This event is called extravasation.
Maltese: Dan l-episodju jissejjaħ ekstravażjoni.
English: Savene powder: Amber-coloured, 36-ml, glass type I vial with stopper made of chlorobutyl rubber and a flip-off cap.
Maltese: Kunjett tal-ħġieġ ta' tip I ta' 36 ml ta; kulur ambra b'tapp tal-lastku magħmul minn chlorobutyl u b'kappa tat-tip flip-off.
English: Women must inform their doctor immediately if they become pregnant (see section 4.3 and 4.6).
Maltese: In-nisa għandhom jinfurmaw lit-tabib tagħhom immedjatament jekk joħorġu tqal (ara sezzjoni 4.3 u 4.6).
English: Decreased appetite
Maltese: Aptit imnaqqas
English: Sodium chloride Potassium chloride Magnesium chloride hexahydrate Sodium acetate trihydrate Sodium gluconate Sodium hydroxide Water for injections
Maltese: Potassium chloride Magnesium chloride hexahydrate Sodium acetate trihydrate Sodium gluconate
English: Day 2: 1000 mg/m2
Maltese: Ġurnata 1: 1000 mg/m2 Ġurnata 2: 1000 mg/m2
English: There is limited evidence from studies that suggests epirubicin clearance may be increased when dexrazoxane is pre-administered, this occurred at high doses of epirubicin (120-135 mg/m2).
Maltese: Hemm evidenza limitata mill-istudji li tissuġġerixxi li t-tneħħija ta' epirubicin tista' tiżdied meta dexrazoxane jingħata minn qabel, dan seħħ b'dożi għoljin ta' epirubicin (120-135 mg/m2).
English: • Phenytoin: cytotoxic agents may reduce the absorption of phenytoin leading to an exacerbation of convulsions.
Maltese: • Phenytoin: sustanzi ċitotossiċi jistgħu jnaqqsu l-assorbiment ta' phenytoin li jwassal għal taħrix tal-konvulżjonijiet.
English: This is equivalent to 81% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 81 % tat-teħid fid-dieta massimu rakkomandat ta' kuljum ta' sodju għal adult.
English: Since renal dysfunction may decrease the rate of elimination of dexrazoxane, patients with impaired renal function should be monitored for signs of haematological toxicity (see section 4.2 for dosing recommendations in patients with moderate to severe renal impairment (creatinine clearance <40 mL/min)).
Maltese: Billi mard fil-funzjoni renali jista' jnaqqas ir-rata ta' eliminazzjoni ta' dexrazoxane, pazjenti b'indeboliment tal-funzjoni renali għandhom jiġu mmonitorjati għal sinjali ta' tossiċità ematoloġika (ara sezzjoni 4.2 għal rakkomandazzjonijiet dwar id-dożaġġ f'pazjenti b'indeboliment renali moderat sa sever (tneħħija ta' krejatinina <40 mL/min)).
English: After reconstitution and dilution:
Maltese: Wara rikonstituzzjoni u dilwizzjoni:
English: Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate, Sodium acetate trihydrate, Sodium gluconate, Sodium hydroxide, Water for injections.
Maltese: Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate, Sodium acetate trihydrate, Sodium gluconate, Sodium hydroxide, Ilma għall-injezzjonijiet.
English: Since liver dysfunction (increases in transaminases and bilirubin) may occur (especially after doses of above 1 000 mg/m2 dexrazoxane), it is recommended that routine liver function tests be performed before each administration of dexrazoxane in patients with known liver function disorders (see section 4.2).
Maltese: Billi jista' jkun hemm mard fil-funzjoni tal-fwied (żidiet fit-transaminases u bilirubin) (speċjalment wara dożi ta' aktar minn 1 000 mg/m2 ta' dexrazoxane), huwa rakkomandat li jitwettqu testijiet ta' rutina tal-funzjoni tal-fwied qabel kull għoti ta' dexrazoxane f'pazjenti b'mard magħruf fil-funzjoni tal-fwied (ara sezzjoni 4.2).
English: The overall ranges and mean of AUC0-24 between days were very similar; it does not appear that there is any significant accumulation of dexrazoxane.
Maltese: Il-meded globali u l-medja tal-AUC0-24 bejn il-jiem kienu simili ħafna; ma jidhirx li hemm xi akkumulazzjoni sinifikanti ta' dexrazoxane.
English: Savene contains the active substance dexrazoxane, which acts as an antidote to anti-cancer medicines called anthracyclines.
Maltese: Savene fih is-sustanza attiva dexrazoxane, li taġixxi bħala antidotu għal mediċini kontra l-kanċer li jissejħu anthracyclines.
English: Dizziness Sensory loss Syncope Tremor
Maltese: Nuqqas t'aptit Telf sensorjali Sinkope Rogħda
English: Overall, the most commonly received anthracycline was epirubicin (56 % of the patients).
Maltese: Kollox ma' kollox, l-aktar anthracycline użat b'mod komuni kien epirubicin (56 % tal-pazjenti).
English: 3.1.2 Inject the entire contents of the syringe into the vial containing the Savene powder.
Maltese: 3.1.2 Injetta l-kontenut kollu tas-siringa fil-kunjett li fih Savene trab.
English: Haemoglobin WBC
Maltese: WBC
English: One emergency kit contains 10 vials of Savene powder and 3 bottles of Savene solvent supplied with 3 bottle hangers.
Maltese: Kitt ta' emerġenza waħda fih 10 kunjetti ta' trab ta' Savene u 3 fliexken ta' solvent ta' Savene fornut bi 3 grampuni tal-fliexken.
English: When mice with experimental daunorubicin extravasation were treated with dexrazoxane systemically combined with topical treatment with DMSO on the daunorubicin-affected skin area, 67 % of the mice developed small skin wounds, whereas dexrazoxane treatment alone completely prevented the daunorubicin-induced skin necrosis in another group of mice.
Maltese: 67 % tal-ġrieden żviluppaw feriti żgħar tal-ġilda, filwaqt li trattament b'dexrazoxane waħdu evita għal kollox in-nekrosi tal-ġilda kkawżata minn daunorubicin fi grupp ieħor ta' ġrieden.
English: • Concomitant vaccination with yellow fever vaccine (see section 4.5).
Maltese: • Tilqim fl-istess ħin mat-tilqim kontra d-deni isfar (ara sezzjoni 4.5).
English: Savene 20 mg/ml powder and solvent for concentrate for solution for infusion Dexrazoxane
Maltese: Savene 20 mg/ml trab u solvent għall-konċentrat għal soluzzjoni għall-infużjoni Dexrazoxane
English: Clinical efficacy and safety The clinical programme for Savene (dexrazoxane) included two open, single-arm, multicentre studies.
Maltese: Il-programm kliniku għal Savene (dexrazoxane) kien jinkludi żewġ studji multiċentriċi, miftuħa fuq driegħ wieħed.
English: Volume of distribution is independent of dose.
Maltese: Il-volum tad-distribuzzjoni huwa indipendenti mid-doża.
English: Signs and symptoms of overdosage are likely to consist of leucopenia, thrombocytopenia, nausea, vomiting, diarrhoea, skin reactions and alopecia.
Maltese: Is-sinjali u s-sintomi ta' dożaġġ eċċessiv aktarx li jikkonsistu minn lewkopenja, tromboċitopenja, nawseja, rimettar, dijarea, reazzjonijiet tal-ġilda u alopeċja.
English: Superficial thrombophlebitis Venous thrombosis limb
Maltese: Tromboflebite superfiċjali Trombożi venuża fir-riġel jew iddriegħ
English: Each vial contains 500 mg dexrazoxane as 589 mg dexrazoxane hydrochloride.
Maltese: Kull kunjett fih 500 mg dexrazoxane bħala 589 mg dexrazoxane hydrochloride.
English: Patients with neutropenia and thrombocytopenia > CTC grade 1 (Common Toxicity Criteria) have not been included in the clinical studies.
Maltese: Pazjenti b'newtropenja u tromboċitopenja > CTC ta' l-ewwel grad ma ġewx inklużi fl-istudji kliniċi.
English: Based on a limited number of patients, interindividual variability calculated as the coefficient of variation (CV %) was estimated to be approximately 30 % for the main pharmacokinetic parameters.
Maltese: Fuq il-bażi ta' numru limitat ta' pazjenti, il-varjabilità bejn persuni differenti kkalkulata bħala l-koeffiċjent ta' varjazzjoni (CV %), kienet stmata li hija madwar 30 % għall-parametri farmakokinetiċi prinċipali.
English: Powder vial:
Maltese: Kunjett tat-trab:
English: White to off-white lyophilisate.
Maltese: - Żomm dan il-fuljett.
English: Systemic clearance is independent of dose.
Maltese: Ittneħħija sistemika hija indipendenti mid-doża.
English: • Infection (after an operation or other infections)
Maltese: • Infezzjoni (wara operazzjoni jew infezzjonijiet oħra)
English: • Dimethylsulfoxide (DMSO) should not be used in patients who are administered dexrazoxane to treat anthracycline extravasation (see section 5.3)
Maltese: • Dimethylsulfoxide (DMSO) m'għandux jintuża f'pazjenti li ngħataw dexrazoxane sabiex jittrattaw l-ekstravazzazzjoni ta' anthracycline (ara sezzjoni 5.3)
English: For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Maltese: Għall-istruzzjonijiet dwar rikostituzzjoni u dilwazzjoni tal-prodott mediċinali qabel ma jingħata, ara sezzjoni 6.6.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for concentrate for solution for infusion 10 vials of 500 mg dexrazoxane 3 bottles of 500 ml solvent and 3 bottle hangers Emergency kit for the treatment of anthracycline extravasation
Maltese: 3 flixken ta' 500 ml solvent u 3 grampuni tal-fliexken Kitt ta' emerġenza għat-trattament ta' ekstravazzazzjoni minħabba anthracycline
English: The following information is based on two clinical studies, TT01 and TT02, of Savene administered to extravasation patients already receiving cycles of chemotherapeutic agents.
Maltese: L-informazzjoni li ġejja hija bbażata fuq żewġ studji kliniċi, TT01 u TT02, ta' Savene mogħti lil pazjenti b'ekstravażjoni li diġà kienu qegħdin jirċievu ċikli ta' aġenti tal-kimoterapija.
English: It is important that you read the entire content of this procedure prior to the preparation of Savene.
Maltese: Huwa importanti li taqra l-kontenut kollu ta' din il-proċedura qabel il-preparazzjoni ta' Savene.
English: The concentration of dexrazoxane following reconstitution with 25 ml Savene solvent is 20 mg/ml.
Maltese: Il-konċentrazzjoni ta' dexrazoxane wara r-rikostituzzjoni b'25 ml ta' solvent ta' Savene hija ta' 20 mg/ml.
English: The Savene solvent contains 98 mg potassium in each 500 ml bottle which may be harmful to people on a low-potassium diet or who have kidney problems.
Maltese: Is-solvent ta' Savene fih 98 mg potassju f'kull flixkun ta' 500 ml li jista' jkun ta' ħsara għal persuni fuq dieta b'teħid baxx ta' potassju jew li għandhom problemi fil-kliewi.
English: Dexrazoxane undergoes intracellular hydrolysis first to its two one-ring open intermediates (B and C) and then to the two-ring opened form (ADR-925) which has a structure similar to EDTA and is a strong chelator of iron and divalent cations as calcium ions.
Maltese: Dexrazoxane jgħaddi minn idrolisi intraċellulari l-ewwel għaż-żewġ intermedji biċ-ċirku miftuħ tiegħu (B u Ċ) u mbagħad għall-forma b'żewġ ċrieki miftuħin (ADR-925) li għandha struttura simili għallEDTA u hija kelatur qawwi tal-ħadid u ketajins bivalenti bħall-joni tal-kalċju.
English: If there is suspicion of extravasation by vesicant compounds other than anthracyclines through the same IV access, e.g. vincristine, mitomycin, and vinorelbine, Savene would not be effective against the effects from these compounds.
Maltese: Jekk ikun hemm suspett ta' ekstravażjoni b'sustanzi li jikkawżaw il-bżieżaq għajr anthracyclines millistess aċċess IV, eżempju vincristine, mitomycin, u vinorelbine, Savene ma jkunx effettiv kontra leffetti minn dawn is-sustanzi.
English: • Dexrazoxane may add to the toxicity induced by the chemotherapy cycle during which the accident took place, requiring careful monitoring of haematological parameters (see section 4.4).
Maltese: • Dexrazoxane jista' jżid mat-tossiċità kkawżata miċ-ċiklu ta' kimoterapija li matulu seħħ linċident, li jitlob monitoraġġ attent tal-parametri ematoloġiċi (ara sezzjoni 4.4)
English: There are limited fertility data from animal studies available, but testicular changes were observed in rats and rabbits following repeat dosing (see section 5.3).
Maltese: Hemm dejta dwar il-fertilità limitata minn studji f'annimali disponibbli, iżda ġie osservat tibdil testikolari fil-firien u l-fniek wara dożaġġ ripetut (ara sezzjoni 5.3).
English: Because of the potential for serious adverse reactions in breast-fed infants exposed to dexrazoxane, breast-feeding is contraindicated during Savene therapy (see section 4.3).
Maltese: Minħabba lpotenzjal ta' reazzjonijiet avversi serji fit-treddigħ ta' trabi esposti għal dexrazoxane, it-treddigħ hu kontra-indikat waqt terapija b'Savene (ara sezzjoni 4.3).
English: Savene powder must be reconstituted in 25 ml Savene solvent to obtain a concentrate that must be further diluted in the remaining Savene solvent prior to administration.
Maltese: It-trab Savene għandu jiġi rikonstitwit f'25 ml ta' Savene solvent sabiex iġġib il-konċentrat li irid ikun dilwit iżjed fis-Savene solvent li jibqa' qabel l-għoti.
English: Savene is indicated in adults for the treatment of anthracycline extravasation.
Maltese: Savene huwa indikat f'adulti għall-kura ta' ekstravażjoni minn anthracycline.
English: System Organ Classes (SOC)
Maltese: Sistema tal-Klassifika tal-organi (SOC) Frekwenza Reazzjonijiet Avversi Infezzjonijiet u infestazzjonijiet
English: The elimination half-life of the two-ring opened metabolite ADR-925 is not given in literature.
Maltese: Il-half life tattneħħija tal-metabolit b'żewġ ċrieki miftuħin ADR-925 mhux mogħti fil-letteratura.
English: The related razoxane has been demonstrated to be embryotoxic in mice, rats and rabbits and teratogenic in rats and mice.
Maltese: Ir-razoxane relatat instab li huwa embrijotossiku fil-ġrieden, firien u fniek u teratoġeniku fil-firien u lġrieden.
English: Chemical and physical in-use stability has been demonstrated for 4 hours when stored at 2 to 8 °C.
Maltese: L-istabbilità kimika u fiżika waqt l-użu ntweriet għal 4 sigħat meta maħżun f'temperatura ta' bejn 2 °C u 8 °C.
English: 36 patients were evaluable for efficacy.
Maltese: 36 pazjent ġew evalwati għall-effikaċja.
English: The carcinogenic potential of dexrazoxane has not been investigated, however, razoxane (the racemic mixture of dexrazoxane and levrazoxane) has been reported to be associated with the development of malignancies in mice (lymphoid neoplasms) and rats (uterine carcinomas) after administration for a prolonged period of time.
Maltese: Il-potenzjal karċinoġenu ta' dexrazoxane ma ġiex studjat, madankollu, razoxane, (it-taħlita racemic ta' dexrazoxane u levrazoxane), kien irrapportat li huwa assoċjat ma' l-iżvilupp ta' tumuri malinni fil-ġrieden (neoplasmi tal-limfa) u l-firien (karċinomi ta' l-utru) wara għoti għal perijodu ta' żmien fit-tul.
English: Two pharmacodynamic properties of dexrazoxane are described in the literature: Prevention of anthracycline cardiotoxicity, and Antineoplastic action
Maltese: Il-prevenzjoni ta' kardjotossiċità minħabba anthracycline, u Azzjoni antineoplastika
English: Caution must be exercised during reconstitution and dilution and the normal procedures for proper handling of cytotoxic medicinal products should be adopted.
Maltese: Għandha tingħata attenzjoni waqt ir-rikonstituzzjoniu d-dilwazzjoni u għandhom jiġu adottati lproċeduri normali għal maniġġ xieraq ta' prodotti mediċinali ċitotossiċi.
English: A number of published reports comprising more than 1000 patients have demonstrated a uniform pattern of dose dependent adverse reactions.
Maltese: Numru ta' rapporti ppubblikati li jinvolvu aktar minn 1000 pazjent urew mudell konsistenti ta' reazzjonijiet avversi dipendenti fuq id-doża.
English: • Due to an increased thrombotic risk in patients with malignant diseases, the use of anticoagulants treatment is frequent.
Maltese: • Minħabba r-riskju trombotiku ogħla f'pazjenti b'mard malinn, l-użu ta' trattamenti b'antikoagulanti guwa frekwenti.
English: If you receive more Savene than you should, you will be closely monitored with specific attention to your blood cells, potential gastro-intestinal signs, skin reactions and hair loss.
Maltese: Jekk tirċievi Savene aktar milli suppost, inti ser tiġi monitorat mill-qrib b'attenzjoni speċifika fuq iddemm tiegħek, sinjali gastrointestinali, reazzjonijiet fil-ġilda u telf ta' xagħar
English: Before infusion, Savene powder must be reconstituted with 25 ml Savene solvent to give a concentration of 20 mg dexrazoxane per ml.
Maltese: Qabel l-infużjoni, it-trab ta' Savene jrid jiġi rikonstitwit b'25 ml ta' Savene solvent biex tinkiseb konċentrazzjoni ta' 20 mg dexrazoxane għal kull ml.
English: Potassium and sodium contents
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT
English: Injection site phlebitis Injection site erythema Fatigue
Maltese: Twebbis fis-sit tal-injezzjoni Edema periferali
English: Do not use this medicine after the expiry date which is stated on the carton, powder vial label, and solvent bottle label after ‘EXP'.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna, it-tikketta tal-kunjett tattrab, u t-tikketta tal-flixkun tas-solvent wara “JIS”.
English: 3.1.4 Allow the vial with the concentrate to stand for 5 minutes at room temperature and check if the solution is homogenous and clear.
Maltese: Ħalli l-kunjett konċentrat joqgħod għal 5 minuti f'temperatura ambjentali u ara jekk issoluzzjoni hijiex omoġenja u ċara.
English: Due to the rarity of the condition only historical data could be used for comparison (demonstrating surgical rates of 35-50 %, in one country 100% in biopsy proven cases).
Maltese: Minħabba r-rarità tal-kondizzjoni setgħet tintuża biss data storika għal tqabbil (li turi rati kirurġiċi ta' 35-50 %, f'pajjiż minnhom 100 % f'każijiet ippruvati b'bijopsija).
English: Patients treated with anticoagulants should be monitored more frequently as cytotoxic agents may interact with oral anticoagulants.
Maltese: Pazjenti trattati b'antikoagulanti għandhom jiġu monitorati b'mod aktar frekwenti peress li s-sustanzi ċitotossiċi jistgħu jirreaġixxu ma antikoagulanti orali.
English: Concentrate and diluted solution may be stored at 2 to 8 °C for 4 hours.
Maltese: Il-konċentrat u soluzzjoni dilwita tista' tinħażen f'temperatura ta' 2 °C għal 8 °C għal 4 sigħat.
English: The pharmacokinetics of the metabolites is derived from a single study with five patients.
Maltese: Il-farmakokinetika tal-metaboliti hija derivata minn studju wieħed b'ħames pazjenti.
English: 4.2 After reconstitution and dilution: - Chemical and physical in-use stability after reconstitution and subsequent dilution in the solvent has been demonstrated for 4 hours when stored at 2 to 8 °C.
Maltese: - L-istabbiltà kimika u fiżika wara r-rikostituzzjoni u d-dilwizzjoni suċċessiva fis-solvent intweriet għal 4 sigħat meta jinħażen f'temperatura ta' 2 sa 8 °C.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 mg dexrazoxane
Maltese: INDIVIDWALI 500 mg dexrazoxane
English: NAME OF THE MEDICINAL PRODUCT Solvent for Savene
Maltese: Mediċini oħra u Savene
English: Repeat-dose toxicity studies with dexrazoxane have shown that primary target organs were tissues that undergo rapid cell division: bone marrow, lymphoid tissue, testes and digestive tract.
Maltese: Studji tat-tossiċità b'doża ripetuta b'dexrazoxane urew li l-organi li jintlaqtu l-ewwel kienu t-tessuti li jgħaddu minn qsim rapidu taċ-ċelloli: mudullun, it-tessut tal-limfa, it-testikoli u l-kanal tal-ikel.
English: Savene solvent: 500 ml solution in bottles made of Type-I (Ph.Eur.)
Maltese: Flixken ta' 500 ml magħmulin minn ħġieġ tat-Tip-I (Ph.Eur).
English: To be used within 4 hours after dilution when stored at 2-8 °C.
Maltese: Biex jintuża fi żmien 4 sigħat wara d-dilwazzjoni meta maħżun f'temperatura ta' bejn 2-8 °C.
English: Concomitant use contraindicated: Yellow fever vaccine: Risk of fatal generalised vaccinial disease (see section 4.3).
Maltese: Riskju ta' mard vaċċinijali ġeneralizzat fatali (ara sezzjoni 4.3).
English: Since Savene will be administered to patients undergoing cytotoxic therapy with anthracyclines its cytotoxic potential (especially resulting in reversible haematological toxicity with a nadir occurring on days 11-12) will therefore add to that of the other chemotherapy administered.
Maltese: Peress li Savene jingħata lil pazjenti li jkunu qegħdin jieħdu terapija ċitotossika b'anthracyclines il-potenzjal ċitotossiku tiegħu (li jirriżulta speċjalment f'tossiċità ematoloġika riversibbli bl-inqas punt iseħħ fil-jiem 11-12) għalhekk ser jiżdied ma' dak tal-kimoterapija l-oħra mogħtija.