qanastek/EMEA-V3 huggingface dataset:
The indicated dose should be administered as an intravenous infusion over 1-2 hours into a large vein in extremity/ area other than the one affected by the extravasation.
Id- doża indikata għandha tingħata bħala infużjoni ġol- vina fuq perijodu ta ’ siegħa sa sagħtejn ġo vina kbira f’ estremità/ żona differenti minn dik affettwata mill- ekstravażjoni.
The first infusion should be initiated as soon as possible and within the first six hours after the accident.
L- ewwel infużjoni għandha tinbeda mill- aktar fis possibbli u fl- ewwel sitt sigħat wara l- aċċident.
Cooling procedures such as ice packs should have been removed from the area at least 15 min before the Savene administration in order to allow sufficient blood flow.
Proċeduri ta ’ tkessiħ bħal pakketti tas- silġ għandhom ikunu tneħħew miż- żona mill- anqas 15- il minuta qabel l- għoti ta ’ Savene sabiex jippermettu fluss suffiċjenti tad- demm.
Treatment Day 2 and Day 3 should start at the same hour (+/ - 3 hours) as on the first day.
It- tieni u t- tielet ġurnata tat- trattament għandhom jibdew fl- istess ħin (+ / - 3 sigħat) ta ’ l- ewwel ġurnata.
2 Before infusion, Savene powder must be reconstituted with 25 ml sterile water to give a concentration of 20 mg dexrazoxane per ml sterile water.
2 Qabel l- infużjoni, it- trab ta ’ Savene jrid jiġi rikonstitwit b’ 25 ml ta ’ ilma sterili biex tinkiseb konċentrazzjoni ta ’ 20 mg dexrazoxane għal kull ml ta ’ ilma sterili.
After reconstitution the solution should be further diluted in the bag with the Savene diluent.
Wara r- rikonstituzzjoni, is- soluzzjoni għandha tiġi dilwita aktar fil- borża bid- dilwent ta ’ Savene.
(See section 6.6).
(Ara sezzjoni 6. 6).
Paediatric patients Savene is not recommended for use in children due to a lack of data on safety and efficacy.
Pazjenti pedjatriċi Savene mhuwiex rakkomandat sabiex jintuża fuq it- tfal minħabba nuqqas ta ’ informazzjoni dwar is - sigurtà u l- effikaċja.
Patients with renal impairment Savene has not been studied in patients with impaired renal function and its use in such patients is not recommended (see section 4.4).
Pazjenti b’ indeboliment renali Savene ma ġiex studjat f’ pazjenti li għandhom funzjoni renali indebolita u l- użu tiegħu mhuwiex rakkomandat f’ dawn il- pazjenti (ara sezzjoni 4. 4).
Decreased renal function may lead to decreased rate of elimination and prolonged systemic exposure.
Funzjoni renali mnaqqsa tista ’ twassal għal rata mnaqqsa ta ’ eliminazzjoni u espożizzjoni sistemika mtawwla.
Patients with hepatic impairment Savene has not been studied in patients with impaired hepatic function and its use in such patients is not recommended (see section 4.4).
Pazjenti b’ indeboliment epatiku Savene ma ġiex studjat f’ pazjenti li għandhom funzjoni epatika indebolita u l- użu tiegħu mhuwiex rakkomandat f’ dawn il- pazjenti (ara sezzjoni 4. 4).
Elderly patients Safety and efficacy have not been evaluated in the elderly.
Pazjenti anzjani Is- sigurtà u l- effikaċja ma ġewx evalwati fost l- anzjani.
4.3 Contraindications
4. 3 Kontra indikazzjonijiet
Women of childbearing potential not using contraceptive measures (see section 4.4 and 4.6).
Nisa b’ potenzjal li jwelldu li ma jużawx miżuri ta ’ kontraċezzjoni (ara sezzjoni 4. 4 u 4. 6).
Concomitant vaccination with yellow fever vaccine (see section 4.5).
Tilqim fl- istess ħin mat- tilqim kontra d- deni isfar (ara sezzjoni 4. 5).
Local examination should be performed on regular basis after treatment until resolution.
Għandha ssir eżami lokali fuq bażi regolari wara t- trattament sakemm jgħaddi għal kollox.
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 reaction from these compounds.
Jekk ikun hemm suspett ta ’ ekstravażjoni b’ sustanzi li jikkawżaw il- bżieżaq għajr anthracyclines mill - istess aċċess IV, eżempju vincristine, mitomycin, u vinorelbine, Savene ma jkunx effettiv kontra r - reazzjoni minn dawn is- sustanzi.
Savene will be administered to patients undergoing cytotoxic therapy with anthracycline containing chemotherapy and its cytotoxic potential (especially resulting in reversible haematological toxicity with a nadir occurring on days 11-12) will therefore be added to that of the other chemotherapy administered.
Savene jingħata lil pazjenti li jkunu qegħdin jieħdu terapija ċitotossika b’ kimoterapija li fiha anthracycline u l- potenzjal ċitotossiku tiegħu (li jirriżulta speċjalment f’ tossiċità ematoloġika riversibbli bl- inqas punt iseħħ fil- jiem 11- 12) għalhekk se jiżdied ma ’ dak tal- kimoterapija l- oħra mogħtija.
Haematological monitoring should therefore be undertaken regularly.
Għalhekk għandu jsir monitoraġġ ematoloġiku b’ mod regolari.
Patients with neutropenia and thrombocytopenia > Common Toxicity Criteria (CTC) grade 1 have not been included in the clinical studies.
Pazjenti b’ newtropenja u tromboċitopenja > Kriterji Komuni tat- Tossiċità (CTC – Common Toxicity Criteria) ta ’ l- ewwel grad ma ġewx inklużi fl- istudji kliniċi.
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 are performed before each administration of dexrazoxane in patients with known liver function disorders.
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.
Since renal dysfunction may decrease the rate of elimination of dexrazoxane, patients with initial impaired renal function should be monitored for signs of haematological toxicity.
Billi mard fil- funzjoni renali jista ’ jnaqqas ir- rata ta ’ eliminazzjoni ta ’ dexrazoxane, pazjenti b’ indeboliment inizjali tal- funzjoni renali għandhom jiġu mmonitorjati għal sinjali ta ’ tossiċità ematoloġika.
As dexrazoxane possesses mutagenic activity, men being treated with dexrazoxane are advised not to father a child during and up to three months after treatment.
Billi dexrazoxane għandu attività mutaġenika, l- irġiel li jkunu qed jiġu ttrattati b’ dexrazoxane huma mogħtija parir biex ma jnisslux tfal waqt jew sa tliet xhur wara t- trattament.
Women of childbearing potential must use contraceptive measures during treatment.
Nisa b’ potenzjal li jinqabdu tqal iridu jużaw miżuri ta ’ kontraċezzjoni waqt it- trattament.
This product is generally not recommended in combination with live attenuated vaccines, or with phenytoin (see section 4.5).
3 Ġeneralment dan il- prodott mhuwiex rakkomandat flimkien ma ’ vaċċini attenwati ħajjin, jew ma ’ phenytoin (ara sezzjoni 4. 5).
3 Dimethylsulfoxide (DMSO) should not be used in patients who are administered dexrazoxane to treat anthracycline-induced extravasation.
Dimethylsulfoxide (DMSO) m’ għandux jintuża f’ pazjenti li jingħataw dexrazoxane għat- trattament ta ’ ekstravażjoni kkawżata minn anthracycline.
As the Savene diluent contains potassium (98 mg/ 500 ml) the plasma potassium level of the patient must be closely monitored in patients at risk of hyperkalaemia.
Billi d- dilwent ta ’ Savene fih il- potassju (98 mg/ 500 ml), il- livell ta ’ potassju fil- plażma tal- pazjent irid jiġi mmonitorjat bir- reqqa f’ pazjenti b’ riskju ta ’ iperkalemija.
It also contains sodium (1.61 g/ 500 ml) which may be harmful to patients on a low sodium diet.
Huwa fih ukoll is- sodju (1. 61 g/ 500 ml) li jista ’ jkun ta ’ ħsara għal pazjenti fuq dieta ta ’ teħid baxx ta ’ sodju.
Due to increase of thrombotic risk in patients with malignant diseases, the use of anticoagulants treatment is frequent.
Minħabba ż- żieda fir- riskju ta ’ trombożi f’ pazjenti b’ mard malinn, l- użu ta ’ trattament kontra l - koagulazzjoni tad- demm huwa wieħed frekwenti.
Cytotoxic agents may interact with oral anticoagulants.
L- aġenti ċitotossiċi jistgħu jinteraġixxu ma ’ sustanzi orali kontra l- koagulazzjoni tad- demm.
Patients treated with anticoagulant should be monitored more frequently.
Pazjenti ttrattati b’ sustanza kontra l- koagulazzjoni tad- demm għandhom jiġu mmonitorjati aktar sikwit.
Concomitant use contraindicated:
Użu flimkien ma ’ sustanzi oħra huwa kontra- indikat:
Yellow fever vaccine:
Vaċċin kontra d- deni isfar:
Risk of fatal generalised vaccinial disease (see section 4.3).
Riskju ta ’ mard tal- ġidri fatali ġeneralizzat (ara sezzjoni 4. 3).
Concomitant use not recommended:
Użu flimkien ma ’ sustanzi oħra mhuwiex rakkomandat:
Live attenuated vaccines: risk of systemic, possible fatal disease.
Vaċċini attenwati ħajjin: mard sistemiku, possibbilment fatali.
This risk is increased in subjects who are already immunosuppressed by their underlying disease Phenytoin: concomitant use of cytotoxic medicinal products may reduce the absorption of phenytoin leading to an exacerbation of convulsions.
Dan ir- riskju huwa akbar f’ pazjenti li diġà huma immunosuppressi mill- marda prinċipali tagħhom Phenytoin: - użu flimkien ta ’ prodotti mediċinali ċitotossiċi ma ’ sustanzi oħra jista ’ jnaqqas l - assorbiment ta ’ phenytoin li jwassal għal taħrix tal- konvulżjonijiet.
Use an inactivated vaccine where this exists (poliomyelitis).
Uża vaċċin mhux attivat fejn dan jeżisti (poljomajelite).
Concomitant use to take into consideration:
Użu flimkien ma ’ sustanzi oħra li għandu jiġi kkunsidrat:
Excessive immunosuppression with risk of lymphoproliferative disease.
Immunosuppressjoni eċċessiva b’ riskju ta ’ mard limfoproliferattiv.
Interaction specific to dexrazoxane:
Interazzjoni speċifika għal dexrazoxane:
When tested in five major cytochrome P450 isoenzymes:
Meta ttestjat f’ ħames isoenżimi cytochrome P459 prinċipali:
CYP1A, CYP2C9, CYP2C19, CYP2D6 and CYP3A4, none of these were inhibited by dexrazoxane.
CYP1A, CYP2C9, CYP2C19, CYP2D6 u CYP3A4, l- ebda wieħed minnhom ma ġie impedut minn dexrazoxane.
Savene may add to the toxicity induced by the chemotherapy cycle during which the accident took place, requiring careful monitoring of haematological parameters.
Savene jista ’ jżid mat- tossiċità kkawżata miċ- ċiklu ta ’ kimoterapija li matulu seħħ l- inċident, li jitlob monitoraġġ attent tal- parametri ematoloġiċi.
There are no data from the use of dexrazoxane in pregnant women.
M’ hemm l- ebda tagħrif dwar l- użu ta ’ dexrazoxane f’ nisa tqal.
Savene may cause foetal harm when administered to pregnant women.
Savene jista ’ jikkawża ħsara fil- fetu meta jingħata lil nisa tqal.
Few pre-clinical data are available with respect to reproductive toxicity (see section 5.3).
Teżisti ftit informazzjoni ta ’ qabel l- użu kliniku rigward it- tossiċità riproduttiva (ara sezzjoni 5. 3).
Savene should not be administered to pregnant women unless clearly necessary.
Savene m’ għandux jingħata lil nisa tqal sakemm dan ma jkunx meħtieġ b’ mod evidenti.
Women of childbearing potential should use contraceptive measures during treatment and should inform their doctor immediately if they become pregnant.
Nisa li jistgħu jinqabdu tqal għandhom jużaw miżuri ta ’ kontraċezzjoni waqt it - trattament u għandhom jinfurmaw lit- tabib tagħhom minnufih jekk jinqabdu tqal.
(See section 4.3) As dexrazoxane possesses mutagenic activity, male patients should use contraceptives during treatment and for 3 months after treatment with dexrazoxane has been concluded (see section 4.4).
(Ara sezzjoni 4. 3) Billi dexrazoxane għandu attività mutaġenika, il- pazjenti rġiel għandhom jużaw kontraċettivi matul it - trattament u għal 3 xhur wara li jkun intemm it- trattament b’ dexrazoxane (ara sezzjoni 4. 4).
It is not known whether dexrazoxane is excreted in human milk.
M’ huwiex magħruf jekk dexrazoxane joħroġx fil- ħalib uman.
Because of the potential for serious adverse reactions in nursing infants exposed to dexrazoxane, mothers should discontinue nursing during Savene therapy.
Minħabba l- potenzjal ta ’ reazzjonijiet negattivi serji fit- treddigħ ta ’ trabi esposti għal dexrazoxane, l- ommijiet għandhom jieqfu mit- treddigħ waqt terapija b’ Savene.
(See section 4.3)
(Ara sezzjoni 4. 3)
4 4.8 Undesirable effects
4 Ma saru l- ebda studji dwar l- effetti fuq il- ħila biex issuq u tħaddem magni iżda mhux probabbli li Savene għandu jaffettwa din il- funzjoni, billi rari ġie assoċjat ma ’ xi indeboliment tas- sistema nervuża ċentrali bħal konfużjoni.
A number of published reports comprising more than 1000 patients have demonstrated a uniform pattern of dose dependant adverse reactions such as nausea/ vomiting, diarrhoea, stomatitis, bone marrow suppression (neutropenia, thrombocytopenia) and affected liver function (increased ALT/ AST).
Numru ta ’ rapporti ppubblikati li jinvolvu aktar minn 1000 pazjent urew mudell konsistenti ta ’ reazzjonijiet avversi dipendenti fuq id- doża bħal nawseja/ rimettar, dijarea, stomatiti, suppressjoni tal - mudullun (newtropenja, tromboċitopenja) u funzjoni tal- fwied affettwata (ALT/ AST akbar).
All adverse reactions have been rapidly reversible.
Ir - reazzjonijiet avversi kollha kienu riversibbli malajr.
The following information is based on two clinical studies, TT01 and TT02, of Savene administered to extravasation patients already receiving cycles of chemotherapeutic agents.
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.
The adverse reactions are those typically seen with standard chemotherapy and also with dexrazoxane:
Ir- reazzjonijiet avversi huma dawk li tipikament jidhru b’ kimoterapija standard u anki b’ dexrazoxane:
Nausea/ vomiting in about one third of the patients, neutropenia and thrombocytopenia in about half of the patients, more rarely increased concentration of liver enzymes (ALT/ AST).
Nawseja/ rimettar f’ madwar terz tal- pazjenti, newtropenja u tromboċitopenja f’ madwar nofs il- pazjenti, aktar rari konċentrazzjoni akbar ta ’ enzimi tal- fwied (ALT/ AST).
The treatment related adverse events observed in the clinical studies are listed below.
L- episodji avversi relatati mat- trattament li ġew osservati fl- istudji kliniċi huma elenkati hawn taħt.
Incidence of adverse reactions (MedDRA) in studies TT01 and TT02 that are related or possible related to treatment.
Inċidenza ta ’ reazzjonijiet avversi (MedDRA) fl- istudji TT01 u TT02 li huma relatati jew possibbilment relatati mat- trattament.
(Note that numbers for Blood and Lymphatic System Disorders are described in a separate table of laboratory examinations) Adverse reactions described as very common were experienced in more than 1 in 10 patients (≥ 1/ 10).
(Innota li l- figuri għall- Mard tad- Demm u tas- Sistema Limfatika huma deskritti f’ tabella separata ta ’ eżamijiet tal- laboratorju) Reazzjonijiet avversi deskritti bħala komuni ħafna seħħew f’ iżjed minn pazjent wieħed minn kull għaxra (≥ 1/ 10).
Adverse reactions described as common were experienced by up to 1 in 10 patients (> 1/ 100 to < 1/ 10).
Reazzjonijiet avversi deskritti bħala komuni seħħew f’ mhux aktar minn pazjent wieħed minn kull għaxra (> 1/ 100 sa < 1/ 10).
(Number of patients = 80) System Organ Classes (SOC)
(Numru ta ’ pazjenti = 80) Sistema tal - Klassifika ta ’ l - organi (SOC)
Preferred Terms (PT)
Termini preferiti (PT)
All grades
Il- gradi kollha
Gastrointestinal Very common disorders
Disturbi gastro - intestinali
15 (18.8%)
15 (18. 8%)
Vomiting Diarrhoea Stomatitis Dry mouth
Rimettar Dijarea Stomatiti Ħalq xott
6 (7.5%) 3 (3.8%) 2 (2.5%) 1 (1.3%)
6 (7. 5%) 3 (3. 8%) 2 (2. 5%) 1 (1. 3%)
0 (0%) 1 (1.3%) 2 (2.5%) 0 (0%)
0 (0%) 1 (1. 3%) 2 (2. 5%) 0 (0%)
General Very common disorders and
Disturbi ġenerali u kondizzjonijiet ta '
Injection site pain
Uġigħ fil- post ta ’ l- injezzjoni
13 (16.3%)
13 (16. 3%)
1 (1.3%)
1 (1. 3%)
administration site conditions
mnejn jingħata
Pyrexia Injection site phlebitis
Deni Flebite fil- post ta ’ l- injezzjoni
6 (7.5%) 5 (6.3%)
6 (7. 5%) 5 (6. 3%)
2 (2.5%) 0 (0%)
2 (2. 5%) 0 (0%)
3 (3.8%)
Eritema fil- post 3 ta ’ l- injezzjoni
2 (2.5%)
2 (2. 5%)
Injection site induration
Ebusija fil- post ta ’ l- injezzjoni
Injection site swelling
Nefħa fil- post ta ’ l- injezzjoni
Oedema peripheral
Edima periferali 1
1 (1.3%)
(1. 3%)
Somnolence
Ħedla tan- ngħas
Infections and Very common infestations
Infezzjonijiet u infestazzjonijiet
Postoperative infection
Infezzjoni ta ’ wara l - operazzjoni
8 (10.0%)
8 (10. 0%)
3 (3.8%)
3 (3. 8%)
Infection Neutropenic infection
Infezzjoni
1 (1.3%) 1 (1.3%)
1 (1. 3%)
0 (0%) 1 (1.3%)
0 (0%)
Injury, Common poisoning and procedural complications
5 Sistema tal - Klassifika ta ’ l - organi (SOC)
Wound complication
Termini preferiti (PT)
3 (3.8%)
1 (1. 3%)
0 (0%)
1 (1. 3%)
Investigations Common
Komuni
Weight decreased
Komplikazzjoni tal- ferita
1 (1.3%)
3 (3. 8%)
5 System Organ Classes (SOC)
Investigazzjonijiet
Frequency
Komuni
Preferred Terms (PT)
Tnaqqis fil- piż
All grades
1 (1. 3%)
Decreased appetite
Tnaqqis fl- aptit
Myalgia
Uġigħ fil - muskoli
Dizziness Sensory loss Syncope Tremor
Sturdament Telf tas- sensi Sinkope Rogħda
2 (2.5%) 1 (1.3%) 1 (1.3%) 1 (1.3%)
2 (2. 5%) 1 (1. 3%) 1 (1. 3%) 1 (1. 3%)
1 (1.3%) 0 (0%) 1 (1.3%) 0 (0%)
1 (1. 3%) 0 (0%) 1 (1. 3%) 0 (0%)
Vaginal haemorrhage
Emorraġija vaġinali
Respiratory, thoracic and
Disturbi respiratorji, toraċiċi
mediastinal disorders
u medjastinali
Alopecia Pruritus
Twaqqigħ tax - xagħar
5 (6.3%) 1 (1.3%)
5 (6. 3%)
Phlebitis Thrombophlebit is superficial
Flebite Tromboflebite superfiċjali
2 (2.5%) 1 (1.3%)
2 (2. 5%) 1 (1. 3%)
Venous thrombosis limb
Trombożi venuża tas - saqajn
Incidence of laboratory abnormalities (all patients) in TT01 and TT02
Inċidenza ta ’ anormalitajiet tal- laboratorju (il- pazjenti kollha) fit- TT01 u TT02 CTC grad 3- 4 Nru ta ’ pazjenti
No of pts with post
Test tal- laboratorju
baseline value
b’ valur post baseline
WBC Neutrophils Platelets Sodium (Hypo) Potassium (Hypo) Potassium (Hyper) Alkaline Phosphatase Bilirubin AST ALT Creatinine LDH Calcium Total (Hypo)
WBC Newtrofili Plejtlits Sodium (Aktar baxx) Potassium (Aktar baxx) Potassium (Aktar għoli) Alkaline Phosphatase Bilirubin AST ALT Krejatinina LDH Calcium Totali (Aktar
45.0% 46.2% 21.3% 6.3% 2.5% 0.0% 0.0% 1.3% 3.5% 3.9% 2.6% 0.0% 7.1%
45. 0% 46. 2% 21. 3% 6. 3% 2. 5% 0. 0% 0. 0% 1. 3% 3. 5% 3. 9% 2. 6% 0. 0% 7. 1%
4.9 Overdose
baxx)
Detoxifying agents for antineoplastic agents, ATC code:
Aġenti ta ’ diżintossifikazzjoni għal aġenti antineoplastiċi, Kodiċi ATC:
Two pharmacodynamic properties of dexrazoxane, its antineoplastic effect and its use in the prevention of anthracycline cardiotoxicity, are described in the literature.
Żewġ kwalitajiet farmakodinamiċi ta ’ dexrazoxane, l- effett antineoplastiku tiegħu u l- użu tiegħu fil - prevenzjoni ta ’ tossiċità minn anthracycline huma deskritti fil- letteratura.
Mechanism of action Dexrazoxane has two major mechanisms of action:
Mekkaniżmu ta ’ azzjoni Dexrazoxane għandu żewġ mekkaniżmi prinċipali ta ’ azzjoni:
Prevention of anthracycline cardiotoxicity: chelation of iron especially through its ring-opened metabolite reduces the iron-dependant free radical oxidative stress associated with anthracycline- induced cardiotoxicity.
Prevenzjoni ta ’ kardjotossiċità minn anthracycline: il- kelazzjoni tal- ħadid speċjalment permezz tal - metabolit biċ- ċirku miftuħ tiegħu tnaqqas l- istress ossidattiv tar- radikali ħielsa dipendenti fuq il- ħadid assoċjat ma ’ kardjotossiċità kkawżata minn anthracycline.
Antineoplastic effect: inhibition of topoisomerase II.
Effett antineoplastiku: inibizzjoni ta ’ topoisomerase II.
It is not known to which extent each of these mechanisms contributes to the protective effect of tissue destruction following anthracycline extravasation.
Mhux magħruf safejn kull wieħed minn dawn il- mekkaniżmi jikkontribwixxi għall- effett protettiv tal - qerda tat- tessut wara ekstravażjoni minn anthracycline.
The chelating property is probably also responsible for an increased urinary excretion of iron and zinc and a decreased serum concentration of calcium as described in a few studies.
Il- karatteristika ta ’ kelazzjoni probabbli hija responsabbli wkoll għal tneħħija akbar ta ’ ħadid u żingu fl- awrina u konċentrazzjoni anqas ta ’ kalċju fis- serum kif deskritt f’ xi studji.
The following efficacy data relate to Savene used as treatment of anthracycline extravasation.
Id- data segwenti dwar l- effikaċja għandha x’ taqsam ma ’ Savene użat bħala trattament għal ekstravażjoni minn anthracycline.
The clinical programme for Savene (dexrazoxane) included two open, single arm, multicentre studies.
Il- programm kliniku għal Savene (dexrazoxane) kien jinkludi żewġ studji multiċentriċi, miftuħa fuq driegħ wieħed.
The overall purpose of each trial was to investigate the efficacy of intravenous Savene in preventing tissue damage from accidentally extravasated anthracycline, and thus preventing the patients from undergoing the routinely used surgical excision of the affected tissue.
L- iskop globali ta ’ kull test kien li tiġi investigata l- effikaċja ta ’ Savene mogħti ġol- vini fil - prevenzjoni ta ’ ħsara fit- tessut mill- ekstravażjoni aċċidentali ta ’ anthracycline, u b’ hekk tevita milli l - pazjenti jkollhom jgħaddu mit- tneħħija kirurġika użata sikwit tat- tessut affettwat.
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) In both studies, the dosage regimen was the same.
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) Fiż- żewġ studji, ir- reġim tad- dożaġġ kien l- istess.
Treatment with Savene had to be started within 6 hours from the incident and was repeated after 24 and 48 hours.
It- trattament b’ Savene kellu jinbeda fi żmien 6 sigħat mill- inċident u ġie ripetut wara 24 u 48 siegħa.
The first and second doses were at 1000 mg/ m2 and the third was 500 mg/ m2.
L- ewwel u t- tieni doża kienu ta ’ 1000 mg/ m2 u t - tielet waħda kienet ta ’ 500 mg/ m2.
A requirement for inclusion in the efficacy part of the study was that the anthracycline extravasation was proven by fluorescence microscopy of one or more biopsies.
Rekwiżit għall- inklużjoni fil- parti dwar l- effikaċja ta ’ l- istudju kien li l- ekstravażjoni minn anthracycline tkun ippruvata b’ mikroskopija fluworexxenti ta ’ bijopsija waħda jew aktar.
Patients with neutropenia and thrombocytopenia > CTC grade 1 have not been included in the clinical studies.
Pazjenti b’ newtropenja u tromboċitopenja > CTC ta ’ l- ewwel grad ma ġewx inklużi fl- istudji kliniċi.
In study TT01 23 patients were entered and received treatment with Savene.
Fl- istudju TT01 iddaħħlu u ngħataw trattament b’ Savene, 23 pazjent.
Eighteen were evaluable for efficacy and safety and a further five patients were evaluable for toxicity only.
Tmintax ġew evalwati għall - effikaċja u s- sigurtà u ħamsa oħra ġew evalwati għat- tossiċità biss.
None of the patients required surgical intervention.
L- ebda pazjent ma kien jeħtieġ intervent kirurġiku.
In study TT02, 57 patients entered the study and received the first dose of Savene.
Fl- istudju TT02, daħlu fl- istudju u rċievew l- ewwel doża ta ’ Savene, 57 pazjent.
36 patients were evaluable for efficacy.
36 pazjent ġew evalwati għall- effikaċja.
Only one of the 36 patients required surgery.
Pazjent wieħed biss mis- 36 kien jeħtieġ kirurġija.
In both studies all patients had received anthracycline.
Fiż- żewġ studji, il- pazjenti kollha kienu rċievew anthracycline.
Overall, the most commonly received anthracycline was epirubicin (56% of the patients).
Kollox ma ’ kollox, l- aktar anthracycline użat b’ mod komuni kien epirubicin (56% tal- pazjenti).
Patients with extravasations from a central venous access device (CVAD) were not included in the efficacy evaluation.
Pazjenti b’ ekstravazzjonijiet minn apparat t’ aċċess venuż ċentrali (CVAD) ma kinux inklużi fl - evalwazzjoni ta ’ l- effikaċja.
In both studies dexrazoxane treatment prevented the development of necrosis, allowed cancer treatment to continue as scheduled in the majority of patients, and reduced the occurrence of sequelae (only few and mild long-term sequelae were observed).
7 Fiż- żewġ studji t- trattament b’ dexrazoxane impedixxa l- iżvilupp ta ’ nekrosi, ippermetta li t- trattament kontra l- kanċer jitkompla kif skedat fil- maġġoranza tal- pazjenti, u naqqas kundizzjonijiet ta ’ wara l - marda (kienu osservati biss ftit kundizzjonijiet ħfief fuq perijodu fit- tul).
Savene is only administered intravenously.
Savene jingħata biss minn ġol- vini.
The apparent volumes of
Tagħrif biblijografiku juri li l- kinetika fis- serum ta ’ dexrazoxane wara għoti ġol- vini, issegwi mudell miftuħ ta ’ żewġ kompartimenti indipendenti mill- iskeda u d- doża.
7 distribution are 0.13-1.3 l/ kg (median 0.49 l/ kg).
Il- volumi evidenti tad - distribuzzjoni huma 0. 13- 1. 3 l/ kg (punt medjan 0. 49 l/ kg).
Volume of distribution is independent of dose.
Il- volum tad- distribuzzjoni huwa indipendenti mid- doża.
AUCs were dose-proportional.
L- AUCs kienu proporzjonali mad- doża.
Tissue distribution is rapid, with the highest levels of unchanged parent compound and hydrolysed product appearing in liver and kidneys.
Id- distribuzzjoni fit- tessut hija rapida, bl- ogħla livelli ta ’ sustanza prinċipali mhux mibdula u prodott idrolizzat jidhru fil- fwied u l- kliewi.
About 2% of dexrazoxane is protein-bound.
Madwar 2% ta ’ dexrazoxane huwa marbut mal- proteini.
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.
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 għall- EDTA u hija kelatur qawwi tal- ħadid u ketajins bivalenti bħall- joni tal- kalċju.
Dexrazoxane displays biphasic elimination kinetics.
Dexrazoxane jippreżenta kinetika ta ’ tneħħija b’ żewġ fażijiet.
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).
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 (punt medjan 2. 8 sigħat).
Total urinary recovery of unchanged dexrazoxane is 34%-60%.
L- irkupru totali fl- awrina ta ’ dexrazoxane mhux mibdul huwa 34% - 60%.
Systemic clearance is independent of dose.
It- tneħħija sistemika hija indipendenti mid- doża.
The pharmacokinetics of the metabolites is derived from a single study with five patients.
Il- farmakokinetika tal- metaboliti hija derivata minn studju wieħed b’ ħames pazjenti.
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), respectively.
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.
The elimination half-life of the two-ring opened metabolite ADR-925 is not given in literature.
Il - half life tat- tneħħija tal- metabolit b’ żewġ ċrieki miftuħin ADR- 925 mhux mogħti fil- letteratura.
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 h.
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.
Clearance may be reduced in patients with low creatinine clearance.
L- eliminazzjoni tista ’ tkun anqas f’ pazjenti bi tneħħija baxxa ta ’ krejatinina.
In vitro studies on dexrazoxane when tested in human microsomes have shown high stability of dexrazoxane indicating that major metabolism via cytochrome P450 is unlikely
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
There is insufficient data available to draw any definite conclusions regarding intrinsic pharmacokinetic factors such as age, gender, race and weight.
M’ hemmx biżżejjed tagħrif disponibbli biex wieħed jiġbed konklużjonijiet preċiżi dwar fatturi farmakokinetiċi bażiċi bħall- età, is- sess, ir- razza u l- piż.
Inter- and intraindividual pharmacokinetic variabilities have not been studied systematically.
Il- varjabilitajiet farmakokinetiċi fl- istess persuna u bejn persuni differenti ma ġewx studjati b’ mod sistematiku.
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.
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.
Dexrazoxane has been shown to possess mutagenic activity.
Dexrazoxane nstab li għandu attività mutaġenika.
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 secondary malignancies in mice (lymphoid neoplasms) and rats (uterine carcinomas) after administration for a prolonged period of time.
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 sekondarji fil- ġrieden (neoplasmi tal- limfa) u l- firien (karċinomi ta ’ l- utru) wara għoti għal perijodu ta ’ żmien fit- tul.
Both of these effects are expected for this class of compound.
Dawn iż- żewġ effetti huma mistennija għal din il- klassi ta ’ taħlita.
Repeat-dose toxicity studies have shown that primary target organs were tissues that undergo rapid cell division: bone marrow, lymphoid tissue, testes and digestive tract.
Studji tat- tossiċità b’ doża ripetuta wrew 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 ta ’ l- ikel.
Myelosuppression is thus common.
Il - mjelosuppressjoni hija għalhekk komuni.
The apparent effects were greater during chronic administration than acute.
L- effetti evidenti kienu akbar waqt għoti kroniku milli akut.
The toxicity in combination with doxorubicin was additive and not synergistic.
It- tossiċità flimkien ma ’ doxorubicin kienet additiva u mhux sinerġetika.
The related razoxane has been demonstrated to be embryotoxic in mice, rats and rabbits and teratogenic in rats and mice.
Ir- razoxane relatat instab li huwa embrijotossiku fil- ġrieden, firien u fniek u teratoġeniku fil- firien u l - ġrieden.
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, Thus, DMSO should not be used in patients treated with dexrazoxane to prevent anthracycline extravasation.
Għalhekk,
Savene powder Hydrochloric acid
Savene trab Hydrochloric acid
8 Savene diluent Sodium chloride Potassium chloride Magnesium chloride hexahydrate Sodium acetate trihydrate Sodium gluconate Sodium hydroxide Water for injections
Sodium chloride Potassium chloride Magnesium chloride hexahydrate Sodium acetate trihydrate Sodium gluconate Sodium hydroxide Ilma għall- injezzjonijiet
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Minħabba li ma sarux studji li juru liema huma l- prodotti li ma jaqblux miegħu, dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti medicinali oħra.
Vials and bags:
Kunjetti u boroż:
After reconstitution and dilution:
Wara rikonstituzzjoni u dilwizzjoni:
Chemical and physical in-use stability has been demonstrated for 4 hours when stored at 2 to 8°C.
L- istabbilità kimika u fiżika waqt l- użu ntweriet għal 4 sigħat meta maħżun f’ temperatura ta ’ bejn 2 °C u 8 °C.
From a microbiological point of view the product should be used immediately.
Minn lat mikrobijoloġiku, il- prodott għandu jintuża minnufih.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 4 hours at 2 to 8°C.
Jekk ma jintużax minnufih, il- ħinijiet u l- kondizzjonijiet effettivi ta ’ ħażna qabel l- użu jkunu fir - responsabbiltà ta ’ l- utent u ġeneralment ma jkunux aktar minn 4 sigħat f’ temperatura ta ’ bejn 2 °C u 8 °C.
Store below 25°C.
Aħżen f’ temperatura taħt 25 °C.
Keep the vials and bags in the outer carton in order to protect from light.
Żomm il- kunjetti u l- boroż fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
Amber coloured glass type I vial with rubber stopper made of chlorobutyl and a flip- off or tear off cap.
Kunjett tal- ħġieġ ta ’ tip I kulur- ambra b’ tapp tal- gomma magħmul minn chlorobutyl u b’ kappa tat- tip flip- off jew li tiċċarrat.
Bags made of polyolefin/ polyamide co-extruded plastic and over wrapped with a protective plastic bag composed of polyamide/ polypropylene.
Boroż magħmulin minn plastic ko- estruż polyolefin/ polyamide u mgeżwer minn barra b’ borża tal- plastik protettiva magħmula minn polyamide/ polypropylene.
Pack sizes:
Daqs tal- pakketti:
Savene is available in a box consisting of 10 vials of Savene powder containing 500 mg dexrazoxane and 3 bags of 500 ml Savene diluent.
Savene huwa disponibbli f’ kaxxa li fiha 10 kunjetti ta ’ Savene trab li fihom 500 mg dexrazoxane u 3 boroż ta ’ 500 ml Savene dilwent.
Before infusion, Savene powder must be reconstituted with 25 ml sterile water to give a concentration of 20 mg dexrazoxane per ml sterile water.
9 Qabel l- infużjoni, it- trab ta ’ Savene jrid jiġi rikonstitwit b’ 25 ml ta ’ ilma sterilizzat biex tinkiseb konċentrazzjoni ta ’ 20 mg dexrazoxane għal kull ml ta ’ ilma sterilizzat.
The reconstituted solution is slightly yellow.
Is- soluzzjoni rikonstitwita hija kemmxejn safranija.
The reconstituted solution should then be diluted in 500 ml Savene diluent.
Is- soluzzjoni rikonstitwita għandha tiġi dilwita f’ 500 ml Savene dilwent.
Caution must be exercised when handling and preparing the reconstituted solution and the normal procedures for proper handling of cytotoxic medicinal products should be adopted.
Għandha tingħata attenzjoni meta jkun qed isir maniġġ u preparazzjoni tas- soluzzjoni rikonstitwita u għandhom jiġu adottati l- proċeduri normali għal maniġġ xieraq ta ’ prodotti mediċinali ċitotossiċi.
If the powder or solution contacts the skin or mucous membranes, wash immediately and thoroughly with water.
Jekk it- trab jew is- soluzzjoni tiġi f’ kuntatt mal- ġilda jew mal- membrani mukużi, laħlaħ minnufih u sewwa bl- ilma.
TopoTarget A/ S Fruebjergvej 3 DK – 2100 Copenhagen Denmark
TopoTarget A/ S Fruebjergvej 3 DK – 2100 Copenhagen Id- Danimarka
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. eu. int/
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. eu. int /
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L - UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
• OTHER CONDITIONS The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market and for as long as the marketed product remains in use.
• KUNDIZZJONIJIET OĦRA Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza tkun fis- seħħ u li din tkun qegħda taħdem qabel ma l- prodott jitpoġġa fis- suq u għall- perijodu ta ’ żmien sakemm il- prodott ikkummerċjalizzat jibqa ’ jintuża.
14 PARTICULARS TO APPEAR ON THE OUTER PACKAGING Box (Pack of 10 vials and 3 bags of diluent)
14 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA Kaxxa (Pakkett ta ’ 10 kunjetti u 3 boroż ta ’ dilwent)
Savene 20 mg/ ml powder for concentrate and diluent for solution for infusion Dexrazoxane
Savene 20 mg/ ml trab għall- konċentrat u dilwent għal soluzzjoni għall- infużjoni Dexrazoxane
STATEMENT OF ACTIVE SUBSTANCE(S)
DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA( i)
Each vial contains 500 mg dexrazoxane (as hydrochloride) Each ml contains 20 mg of dexrazoxane after reconstitution with 25 ml of water for injections
Kull kunjett fih 500 mg dexrazoxane (bħala hydrochloride) Kull ml fih 20 mg ta ’ dexrazoxane wara rikonstituzzjoni b’ 25 ml ta ’ ilma għall- injezzjonijiet
Hydrochloric acid
Hydrochloric acid
Sodium chloride Potassium chloride Magnesium chloride hexahydrate Sodium acetate trihydrate Sodium gluconate Sodium hydroxide Water for injections
Sodium chloride Potassium chloride Magnesium chloride hexahydrate Sodium acetate trihydrate Sodium gluconate Sodium hydroxide Ilma għall- injezzjonijiet
Powder for concentrate and diluent for solution for infusion 10 vials of 500 mg dexrazoxane 3 bags of 500 ml diluent
Trab għal konċentrat u dilwent għal soluzzjoni għall- infużjoni 10 kunjetti ta ’ 500 mg dexrazoxane 3 boroż ta ’ 500 ml dilwent
Intravenous use after reconstitution and dilution Read the package leaflet before use
Użu għal ġol- vini wara rikonstituzzjoni u dilwizzjoni Aqra l- fuljett ta 'tagħrif qabel l- użu
To be administered under the supervision of a physician experienced in the use of cytotoxic agents
Għandu jingħata taħt is- superviżjoni ta ’ tabib b’ esperjenza fl- użu ta ’ aġenti ċitotossiċi
Store below 25°C Reconstituted and diluted solution may be stored at 2 to 8°C for 4 hours Keep vials and bags in the outer carton in order to protect from light
15 Aħżen f’ temperatura taħt 25 °C Soluzzjoni rikonstitwita u dilwita tista ’ tinħażen f’ temperatura ta ’ 2 °C għal 8 °C għal 4 sigħat Żomm il- kunjetti u l- boroż fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl
Contains cytostatics.
Fih cytostatics.
Emergency kit for Anthracycline Extravasation
Kitt ta ’ emerġenza għal ekstravażjoni minn Anthracycline
No information in Braille is available.
M’ hemm ebda tagħrif bil- Braille disponibbli.
Savene powder Dexrazoxane Powder for concentrate Intravenous use after reconstitution and dilution
Savene trab Dexrazoxane Trab għal konċentrat Użu għal ġol- vini wara rikonstituzzjoni u dilwizzjoni
17 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
17 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
Infusion bag
Borża ta ’ infużjoni
Savene diluent
Savene dilwent:
Diluent for solution for infusion 500 ml
Dilwent għal soluzzjoni għal infusjoni 500 ml
Keep in the outer carton in order to protect from light
Żomm fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl
Contains after reconstitution and dilution cytostatics Any unused product or waste material should be disposed of in accordance with local requirements
Wara rikonstituzzjoni u dilwizzjoni fih cytostatics
18 11.
18 Kull fdal tal- prodott li ma jiġix użat jew skart li jibqa 'wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali
No information in Braille is available
M’ hemm ebda tagħrif bil- Braille disponibbli
20 PACKAGE LEAFLET:
20 FULJETT TA 'TAGĦRIF:
Savene 20 mg/ ml powder for concentrate and diluent for solution for infusion
Savene 20 mg/ ml trab għall- konċentrat u dilwent għal soluzzjoni għall- infużjoni
Read all of this leaflet carefully before you start using this medicine
Aqra sew dan il- fuljett kollu qabel tibda tieħu din il- mediċina
please tell your doctor.
imsemmijin f' dan il- fuljett, jekk jogħġbok, għid lit- tabib tiegħek.
What Savene is and what it is used for 2.
X' inhu Savene u għalxiex jintuża 2.
Before you are given Savene 3.
Qabel ma tieħu Savene 3.
How to use Savene 4.
Kif għandek tuża Savene 4.
Possible side effects 5 How to store Savene 6.
Effetti sekondarji li jista ’ jkollu 5 Kif taħżen Savene 6.
WHAT SAVENE IS AND WHAT IT IS USED FOR
X' INHU SAVENE U GĦALXIEX JINTUŻA
Savene is a detoxifying agent for anti-cancer treatment.
Savene huwa aġent ta ’ diżintossifikazzjoni għat- trattament kontra l- kanċer.
Most anti-cancer medicines are administered intravenously.
Il- biċċa l- kbira tal- mediċini kontra l- kanċer jingħataw fil- vini.
Occasionally an accident occurs and the medicine is infused outside the vein and into the surrounding tissue.
Kultant iseħħ inċident u l- mediċina tiġi infuża barra l- vina u fit- tessut tal- madwar.
This event is called extravasation.
Dan l- episodju jissejjaħ ekstravażjoni.
It is a serious complication as it can cause severe tissue damage.
Huwa komplikazzjoni serja billi tista ’ tikkawża ħsara serja fit- tessut.
Savene is used as an antidote to treat extravasations caused by the group of anti-cancer medicines called anthracyclines.
Savene jintuża bħala antidotu biex jiġu ttrattati ekstravażjonijiet ikkawżati mill- grupp ta ’ mediċini għal kontra l- kanċer imsejħa anthracyclines.
BEFORE YOU ARE GIVEN SAVENE
QABEL MA TIEĦU SAVENE
Savene will not be used:
Tieħux Savene:
- If you are allergic (hypersensitive) to dexrazoxane or any of the other ingredients of Savene
- Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal dexrazoxane jew sustanzi oħra ta '
- If you are planning to become pregnant and do not use adequate contraceptive measures
- Jekk qed tippjana li tinqabad tqila u ma tużax miżuri adegwati ta ’ kontraċezzjoni
- If you are breast-feeding
- Jekk qiegħda tredda ’
- If you are given yellow fever vaccine
- Jekk tingħata vaċċin kontra d- deni isfar
Special care with Savene should be taken
Oqgħod attent ħafna b’ Savene
- Savene should only be given to you if you have had an extravasation in connection with
- Savene għandu jingħatalek biss jekk ikollok ekstravażjoni b’ rabta ma ’ kimoterapija li fiha
anthracycline-containing chemotherapy.
anthracycline.
- During treatment with Savene you will have blood tests taken regularly to check your blood
- Waqt trattament b’ Savene, isirulek testijiet tad- demm b’ mod regolari sabiex jiġu kkontrollati ċ -
cells.
ċelloli tad- demm tiegħek.
- If you have liver dysfunction your doctor will monitor your liver function during treatment
- Jekk ikollok disturb tal- funzjoni tal- fwied, it- tabib tiegħek għandu jimmonitorja l- funzjoni tal -
- If you have kidney dysfunction your doctor will monitor for signs of changes to your blood
- Jekk ikollok disturb tal- funzjoni tal- kliewi, it- tabib tiegħek għandu joqgħod attent għal sinjali
cells.
ta ’ bidliet fiċ- ċelloli tad- demm tiegħek.
- Men being treated with dexrazoxane are advised not to father a child during and up to three
- L- irġiel li jkunu qed jiġu ttrattati b’ dexrazoxane huma mogħtija l- parir biex ma jnisslux tfal
months after treatment.
matul jew sa tliet xhur wara t- trattament.
- Women of childbearing potential must use contraceptive measures during treatment.
- Nisa b’ potenzjal li jinqabdu tqal iridu jużaw miżuri ta ’ kontraċezzjoni waqt it- trattament.
- If you receive live attenuated vaccines or phenytoin (anti-epileptic medicines).
- Jekk tingħata vaċċini attenwati ħajjin jew phenytoin (mediċini kontra l- epilessija).
- Savene should not be administered to children.
- Savene m’ għandux jingħata lit- tfal.
Taking other medicines Savene should not be mixed with any other medicines during the infusion.
Meta tużu mediċini oħra Savene m’ għandux jitħallat ma ’ mediċini oħra waqt l- infużjoni.
21 Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
21 Mhux rakkomandat li tuża xi trattament mediku ieħor mingħajr ma tinforma lit- tabib tiegħek billi jista ’ jkun hemm interazzjonijiet bejn Savene u mediċini oħra.
Pregnancy and breast-feeding Savene should not be administered if you are pregnant.
Tqala u Treddigħ Savene m’ għandux jingħata lil nisa tqal.
If you are a man, you must take adequate contraceptive precautions during therapy and for at least three months after treatment.
Jekk inti raġel, għandek tieħu prekawzjonijiet ta ’ kontraċezzjoni adegwati matul it- terapija u għal mill- inqas tliet xhur wara t- trattament.
You must not breast-feed while you are treated with Savene.
M’ għandekx tredda ’ waqt li tkun qed tiġi ttrattata b’ Savene.
Ask your doctor or pharmacist for advice before taking any medicine.
Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tibda tieħu xi mediċina.
Driving and using machines No studies on the effects on the ability to drive and use machines have been performed but it is unlikely that Savene will affect this function.
Sewqan u tħaddim ta 'magni Ma sarux studji dwar l- effetti fuq il- ħila biex issuq u tħaddem magni iżda mhux probabbli li Savene jaffettwa din il- funzjoni.
Important information about some of the ingredients of Savene The Savene diluent contains potassium (98 mg/ 500 ml) which may be harmful to people on a low potassium diet.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Savene Id- dilwent ta ’ Savene fih potassium (98 mg/ 500 ml) li jista ’ jkun ta ’ ħsara għal persuni fuq dieta b’ teħid baxx ta ’ potassium.
It also contains sodium (1.61 g/ 500 ml) which may be harmful to people on a low sodium diet.
Huwa fih ukoll sodium (1. 61 g/ 500 ml) li jista ’ jkun ta ’ ħsara għal persuni fuq dieta b’ teħid baxx ta ’ sodium.
HOW TO USE SAVENE
KIF GĦANDEK TUŻA SAVENE
Usual dose The dose will depend on your height and weight.
Doża normali Id- doża tiddependi fuq it- tul u l- piż tiegħek.
Your doctor will calculate your body surface area in square meter (m2) and will determine the dose you should receive.
It- tabib tiegħek jikkalkula l- erja tas- superfiċje ta ’ ġismek f’ metri kwadri (m2) u jistabbilixxi d- doża li għandek tirċievi.
The usual adult dose is Day 1 and Day 2:
Id- doża normali għall- adulti hija Jum 1 u Jum 2:
1000 mg/ m2 Day 3:
1000 mg/ m2 Jum 3:
Savene will be given by infusion into one of your veins.
Savene jingħata b’ infużjoni f’ waħda mill- vini tiegħek.
The infusion will last 1-2 hours.
L- infużjoni ddum bejn siegħa u sagħtejn.
Before infusion, Savene powder is reconstituted with 25 ml sterile water to give a concentration of 20 mg dexrazoxane per ml sterile water.
Qabel l- infużjoni, it- trab ta ’ Savene jiġi rikonstitwit b’ 25ml ilma sterilizzat biex tinkiseb konċentrazzjoni ta ’ 20 mg dexrazoxane għal kull ml ta ’ ilma sterilizzat.
Frequency of administration You will receive your infusion once daily for 3 consecutive days.
Frekwenza ta ’ l- għoti Inti se tingħata l- infużjoni tiegħek darba kuljum għal 3 ijiem konsekuttivi.
The first infusion will be given as soon as possible, and within the first six hours, after extravasation with an anthracycline medicine.
L- ewwel infużjoni se tingħata mill- aktar fis, u fl- ewwel sitt sigħat, wara ekstravażjoni b’ mediċina anthracycline.
Like all medicines, Savene can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Savene jista 'jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Side effects described as very common were experienced by more than 1 in 10 patients.
L- effetti sekondarji deskritti bħala komuni ħafna kienu esperjenzati minn aktar minn 1 minn kull 10 pazjenti.
Side effects described as common were experienced by up to 1 in 10 patients.
L- effetti sekondarji deskritti bħala komuni kienu esperjenzati sa 1 minn kull 10 pazjenti.
The very common (more than 1 in 10 patients) side effects are:
L- effetti sekondarji komuni ħafna (aktar minn 1 minn kull 10 pazjenti) huma:
Nausea.
Nawseja.
Pain in the blood vessel where the treatment is given.
Uġigħ fil- vina fejn tingħata t- trattament.
Very common side effects are furthermore a temporary lowering of the white blood cells, neutrophils and the platelets, side effects which also are caused by the chemotherapy you receive for your disease.
Effetti sekondarji komuni ħafna jistgħu jinkludu wkoll tnaqqis temporanju taċ- ċelloli bojod tad- demm, newtrofils u l- plejtlits, effetti sekondarji li huma kkawżati wkoll mill- kimoterapija li tirċievi għall- marda tiegħek.