natgillin/translations-raw huggingface dataset:
Savene should not be administered if you are pregnant. 
Zdravila Savene vam ne smejo dajati, če ste noseči.
5 How to store Savene Contents of the pack and other information 
5 Shranjevanje zdravila Savene Vsebina pakiranja in dodatne informacije
Clinical efficacy and safety The clinical programme for Savene (dexrazoxane) included two open, single-arm, multicentre studies. 
Klinična učinkovitost in varnost Klinični program za zdravilo Savene (deksrazoksan) je obsegal dve odprti multicentrični študiji brez primerjalne skupine.
There are limited fertility data from animal studies available, but testicular changes were observed in rats and rabbits following repeat dosing. 
Na voljo so omejeni podatki o plodnosti iz študij na živalih, vendar so bile pri podganah in kuncih pri ponavljajočih se odmerkih opazne spremembe na modih.
Do not use this medicine after the expiry date which is stated on the carton, powder vial label, and solvent bottle label after ‘EXP'. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini, nalepki viale s praškom in nalepki steklenice z vehiklom poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
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. 
Vehikel zdravila Savene vsebuje tudi 1,61 g natrija v 500 ml steklenici, kar je enako 81 % največjega dnevnega vnosa natrija za odrasle osebe, ki ga priporoča SZO in znaša 2 g.
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. 
3.1 Priprava praška Savene za pripravo koncentrata 3.1.1 Z injekcijsko brizgo, ki ima nameščeno iglo, aseptično povlecite 25 ml iz steklenice z vehiklom
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). 
Ledvične okvare Pri bolnikih z zmerno do hudo okvaro ledvic (očistek kreatinina < 40 ml/min) je treba odmerek Savene zmanjšati za 50 % (oglejte si poglavji 4.4 in 5.2).
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. 
4.2 Po rekonstituciji in redčenju: - Dokazali so, da je zdravilo po rekonstituciji in redčenju v vehiklu kemično in fizikalno stabilno do 4 ure, če se shranjuje pri temperaturi 2 do 8 °C.
Treatment should be given once daily for 3 consecutive days. 
Odmerjanje Zdravljenje traja 3 zaporedne dni, enkrat dnevno.
In study TT02, 57 patients entered the study and received the first dose of Savene. 
V študiji TT02 so vključili 57 bolnikov, ki so prejeli prvi odmerek zdravila Savene.
• Phenytoin: cytotoxic agents may reduce the absorption of phenytoin leading to an exacerbation of convulsions. 
• Fenitoin: sočasna uporaba citotoksičnega zdravila lahko zmanjša absorpcijo fenitoina, kar lahko poslabša epileptične krče.
Other medicines and Savene Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines. 
Obvestite zdravnika ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Incidence of laboratory abnormalities in TT01 and TT02 (n=80 patients) Lab test 
Pojavnost nenormalnosti rezultatov laboratorijskih preiskav v TT01 in TT02 (n=80 bolnikov) Laboratorijska preiskava
Patients treated with anticoagulants should be monitored more frequently as cytotoxic agents may interact with oral anticoagulants. 
Bolnike, ki se zdravijo z antikoagulanti je treba pogosteje spremljati, saj lahko pride do interakcije med cititoksičnimi zdravili in peroralnimi antikoagulanti.
Infection Neutropenic infection 
Okužbe nevtropenična okužba
Thus, dimethylsulfoxide (DMSO) should not be used in patients who are administered dexrazoxane to treat anthracycline extravasation. 
Zato se dimetilsulfoksid (DMSO) ne sme uporabiti pri bolnikih, ki za zdravljenje antraciklinske ekstravazacije prejemajo deksrazoksan.
Clinical trial TT04 was conducted on 6 female patients undergoing treatment for anthracycline extravasations. 
Klinična raziskava TT04 je vključevala 6 bolnic, ki so se zdravile zaradi antraciklinskih ekstravazacij.
To be used within 4 hours after dilution when stored at 2-8 °C. 
Raztopino uporabite v 4 urah po razredčitvi, shranjeno pri temperaturi od 2-8 °C.
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. 
Vehikel Savene vsebuje 98 mg kalija v 500 ml steklenici, ki je lahko škodljiv za osebe na dieti z nadzorovanim vnosom kalija ali bolnike z levičnimi težavami.
When tested in five major cytochrome P450 isoenzymes CYP1A, CYP2C9, CYP2C19, CYP2D6 and CYP3A4, none of these were inhibited by dexrazoxane. 
Pri preizkušanju petih glavnih izoencimov citokroma P450 (CYP1A, CYP2C9, CYP2C19, CYP2D6 in
• Inflammation of a blood vessel just under the skin, often with a small blood clot 
• vnetje krvne žile na mestu zdravljenja (flebitis), • vnetje krvne žile tik pod kožo, pogosto z majhnim krvnim strdkom,
3.1.5 Keep and store the opened solvent bottle under aseptic conditions because it is needed for dilution of the concentrate. 
3.1.5 Odprte steklenice z vehiklom shranjujte pod aseptičnimi pogoji, ker boste vehikel potrebovali za redčenje koncentrata.
Treatment with Savene had to be started within 6 hours from the incident and was repeated after 24 and 48 hours. 
Zdravljenje so ponovili po 24 ter 48 urah.
The dose will depend on your height, weight and kidney function. 
Odmerek je odvisen od telesne višine, mase in delovanja ledvic.
In studies, dexrazoxane did not affect the pharmacokinetics of doxorubicin. 
V raziskavah deksrazoksan ni vplival na farmakokinetiko doksorubicina.
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). 
Na voljo so omejeni podatki o plodnosti iz študij na živalih, vendar so bile pri podganah in kuncih pri ponavljajočih se odmerkih opazne spremembe na modih (glejte poglaje 5.3).
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. 
Raziskave toksičnosti ponavljajočih se odmerkov deksrazoksana kažejo, da so bila najprej prizadeta tkiva s hitro delitvijo celic: kostni mozeg, limfna tkiva, testisi in prebavni trakt.
- If you have liver problems, your doctor will monitor your liver function during treatment. 
- Če imate težave z jetri, bo zdravnik med zdravljenjem spremljal delovanje jeter.
In study TT01, 23 patients were entered and received treatment with Savene. 
V študiji TT01 so vključili 23 bolnikov, ki so prejeli zdravilo Savene.
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. 
Skupni razpon in povprečne vrednosti AUC0-24 med posameznimi dnevi so zelo podobne, kar kaže na zanemarljivo stopnjo kopičenja deksrazoksana.
• Pneumonia (lung infection) 
• pljučnica (okužba pljuč),
3.2 Dilution of the concentrate 3.2.1 Up to four vials containing Savene concentrate may be necessary to obtain the required dose for the patient. 
3.2 Redčenje koncentrata 3.2.1 Da dosežete potreben odmerek za bolnika, boste morda potrebovali do štiri viale koncentrata zdravila Savene.
The solution must not be mixed with any other medicines. 
Raztopine ne smete mešati z nobenim drugim zdravilom.
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) 
Pojavnost neželenih učinkov (MedDRA) v študijah TT01 in TT02 (n=80 bolnikov) (Številke za „Bolezni krvi in limfatičnega sistema“ so navedene v ločeni tabeli laboratorijskih preiskav)
Dexrazoxane has not been studied in patients with impaired hepatic function and its use in such patients is not recommended (see section 4.4). 
Deksrazoksana niso preučevali pri bolnikih z okvaro jeter, zato uporaba zdravila pri teh bolnikih ni priporočljiva (glejte poglavje 4.4).
Occasionally an accident occurs and the medicine is infused outside the vein and into the surrounding tissue or leaks from the vein into the surrounding tissue. 
V določenih primerih se zdravilo nenamerno infundira izven vene v okolnje tkivo, oziroma izteče iz vene v okoljnje tkivo.
Continuous monitoring Local examination should be performed on a regular basis after treatment until resolution. 
Po zdravljenju je treba prizadeto področje redno pregledovati, dokler stanje ne preneha.
Dexrazoxane displays biphasic elimination kinetics. 
Izločanje Deksrazoksan ima dvofazno kinetiko izločanja.
Tissue distribution is rapid, with the highest levels of unchanged parent compound and hydrolysed product appearing in liver and kidneys. 
nespremenjena starševska spojina ima najvišjo koncentracijo, v jetrih in ledvicah se pojavijo hidrolizirani produkti.
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). 
Ker lahko, zlasti po odmerkih deksrazoksana nad 1.000 mg/m2, pride do disfunkcije jeter (zvišane vrednosti transaminaz in bilirubina), je pri bolnikih z dokazano okvaro jeter priporočljivo opraviti redne preiskave jetrne funkcije pred vsakim odmerkom deksrazoksana (glejte poglavje 4.2).
Savene will be given to you under the control of a doctor experienced in the use of anti-cancer treatments. 
Zdravilo Savene boste prejeli pod nadzorom zdravnika, ki ima izkušnje pri uporabi zdravil proti raku.
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. 
Ledvična okvara V primerjavi z zdravimi poskusnimi osebami (očistek kreatinina (CLCR) > 80 ml/min), je bila izpostavljenost pri osebah z zmerno (CLCR 30-50 ml/min) do hudo (CLCR < 30 ml/min) okvaro ledvic 2-krat večja.
3.2.5 As with all parenteral products, Savene concentrate and infusion solution should be inspected visually for particulate matter and discoloration prior to administration. 
3.2.5 Kot vsa parenteralna zdravila je treba koncentrat zdravila Savene in raztopino zdravila Savene za infundiranje pred uporabo s prostim očesom preveriti na prisotnost delcev ali razbarvanje.
Dexrazoxane should not be administered to pregnant women unless clearly necessary. 
Deksrazoksana ne smete dajati nosečnicam, razen če je nujno potrebno.
This risk is increased in subjects who are already immunosuppressed by their underlying disease or by concomitant chemotherapy. 
To tveganje je večje pri osebah, ki imajo zaradi obstoječe bolezni ali hkratne kemoterapije oslabljeno delovanje imunskega sistema.
Concentrate and diluted solution may be stored at 2 to 8 °C for 4 hours. 
Koncentrat in razredčena raztopina se lahko hrani 4 ure pri 2 do 8 °C.
Contains cytotoxics. 
Vsebuje citotoksike.
Interaction specific to dexrazoxane: 
Interakcija, specifična za deksrazoksan:
Solvent bottle: 
Steklenica z vehiklom:
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)). 
Ker lahko moteno delovanje ledvic zniža stopnjo izločanja deksrazoksana, je treba pri bolnikih z motenim delovanjem ledvic spremljati znake hematološke toksičnosti (oglejte si poglavje 4.2, ki vsebuje priporočila za odmerjanje pri bolnikih z zmerno do hudo okvaro ledvic (očistek kreatinina < 40 ml/min)).
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. 
Ko so miši z eksperimentalno izzvano daunorubicinsko ekstravazacijo zdravili s sistemskim deksrazoksanom in zunanjo uporabo DMSO na delu kože, prizadetem zaradi daunorubicina, so se pri 67 % miši pojavile majhne kožne ranice.
Savene is used to treat anthracyline extravasation in adults. 
Zdravilo Savene se uporablja za zdravljenje ekstravazacije antraciklina pri odraslih.
Savene solvent contains 98 mg potassium per 500 ml bottle. 
Vehikel zdravila Savene vsebuje 98 mg kalija v 500 ml steklenici.
If the powder or solution contacts the skin or mucous membranes, wash immediately and thoroughly with water. 
Če prašek ali raztopina prideta v stik s kožo ali sluznicami, prizadeto področje nemudoma temeljito sperite z vodo.
Common: may affect up to 1 in 10 people 
Pogosti: pojavijo se pri največ 1 od 10 bolnikov
4.6 Fertility, pregnancy and lactation 
4.6 Plodnost, nosečnost in dojenje Ženske v rodni dobi / kontracepcija pri moških in ženskah
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. 
Karcinogenega potenciala deksrazoksana še niso raziskali, vendar je dolgoročno dajanje razoksana (racemno zmes deksrazoksana in levrazoksana), povezano s pojavom malignih tvorb pri miših (limfatične neoplazme) in podganah (maternični karcinomi).
Solutions containing a precipitate should be discarded. 
Raztopine, ki vsebujejo oborino, morate zavreči.
3.2.3 Mix the solution by agitating gently the infusion bottle. 
3.2.3 Raztopino premešajte z rahlim stresanjem infuzijske steklenice.
This leaflet was last revised in MM/YYYY 
Navodilo je bilo nazadnje revidirano dne MM/LLLL Drugi viri informacij
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), 
Povprečni razpolovni čas izločanja je za odprti intermediat z enim obročem B 0,9-3,9 h (n=5), za odprti intermediat z enim obročem C pa 0,5-0,8 h (n=3).
The safety and efficacy of Savene in children below the age of 18 years have not been established and no data are available. 
Pediatrična populacija Varnost in učinkovitost zdravila Savene pri otrocih, mlajših od 18 let, nista bili dokazani.
The adverse reactions were those typically seen with standard chemotherapy and also with 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). 
Opazili so neželene učinke, značilne za standardno kemoterapijo in deksrazoksan: slabost/bruhanje so opazili pri približno tretjini bolnikov, nevtropenijo in trombocitopenijo pri približno polovici bolnikov,
For intravenous use after reconstitution and dilution. 
Za intravensko uporabo po rekonstituciji in razredčenju.
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. 
Pred dajanjem je treba prašek Savene pripraviti s 25 ml vehikla Savene, da dobite koncentrat, ki ga je treba dodatno razredčiti v preostanku vehikla Savene.
White to off-white lyophilisate. 
bel do belkast liofilizat.
How to use Savene 
Kako uporabljati zdravilo Savene
Savene must be administered under the supervision of a physician experienced in the use of anticancer medicinal products. 
Zdravilo Savene je treba uporabiti pod nadzorom zdravnika, ki ima izkušnje pri uporabi zdravil proti raku.
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. 
Porazdelitveni volumen v stanju dinamičnega ravnovesja deksrazoksana je znašal 30,5 l ±11,1 za 1. dan in 35,8 l ±19,7 za 2. dan. Razpolovni čas terminalne eliminacije je bil konsistenten od 1. do 3. dne (2,1-2,2 h).
The elimination half-life of the two-ring opened metabolite ADR-925 is not given in literature. 
925 v literaturi ni objavljen.
Postoperative infection 
Zelo pogosti postoperativne okužbe
Talk to your doctor or nurse before using Savene: - Savene should only be given to you if you have an extravasation in connection with anthracycline-containing chemotherapy. 
Opozorila in previdnostni ukrepi - Zdravilo Savene lahko prejmete le, če je pri vas prišlo do ekstravazacije v zvezi s kemoterapijo,
• Allergic reactions, symptoms of which could be itching (pruritis), rash, facial/throat swelling, 
• alergijske reakcije s simptomi, kot so srbenje (pruritus), izpuščaj, otekanje obraza/žrela,
• Dry mouth 
• vnetje ust,
Excipients with known effects: Solvent bottle: 
Pomožne snovi z znanimi učinki:
Savene solvent: 500 ml solution in bottles made of Type-I (Ph.Eur.) 
500 ml raztopina v steklenicah iz stekla tipa I (po Evropski farmakopeji).
In particular, tell your doctor or nurse if you are taking or may take any of the following medicines: - Vaccines: you must not use Savene if you are going to receive yellow fever vaccine and it is not recommended that you use Savene if you are going to receive a vaccine containing live virus particles. 
- Cepiva: zdravila Savene ne smete prejeti, če boste cepljeni proti rumeni mrzlici, hkrati pa uporaba zdravila Savene ni priporočljiva, če boste prejeli cepivo, ki vsebuje delce živih virusov.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING KIT BOX (1 KIT CONSISTING OF 10 POWDER VIALS AND 3 SOLVENT BOTTLES) 
PODATKI NA ZUNANJI OVOJNINI KOMPLET V ŠKATLI (KOMPLET VSEBUJE 10 VIAL S PRAŠKOM IN 3 STEKLENICE
Before infusion, Savene powder must be reconstituted with 25 ml Savene solvent to give a concentration of 20 mg dexrazoxane per ml. 
Pred infundiranjem je treba prašek Savene pripraviti s 25 ml vehikla Savene, da nastane koncentracija 20 mg deksrazoksana na ml.
After reconstitution with 25 ml Savene solvent, 1 ml of concentrate contains 20 mg dexrazoxane. 
Po pripravi s 25 ml vehikla Savene, 1 ml koncentrata vsebuje 20 mg deksrazoksana.
wheezing, breathlessness or difficult breathing, changes in levels of consciousness, hypotension, 
piskanje v prsih, zasoplost ali težave pri dihanju, spremembe stopnje zavesti, hipotenzija (nizek krvni tlak), nenadna omedlevica.
OTHER SPECIAL WARNING(S), IF NECESSARY To be administered under the supervision of a physician experienced in the use of cytotoxic agents. 
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Uporabiti pod nadzorom zdravnika, ki ima izkušnje pri uporabi citotoksičnih zdravil.
The concentration of dexrazoxane following reconstitution with 25 ml Savene solvent is 20 mg/ml. 
Koncentracija deksrazoksana po rekonstituciji s 25 ml vehikla Savene je 20 mg/ml.
What you need to know before you use Savene 
Kaj morate vedeti, preden boste uporabili zdravilo Savene Ne uporabljajte zdravila Savene:
B-1420 Braine-L'Alleud Belgium 
Rue de la Papyrée 2-4-6 B-1420 Braine-L'Alleud Belgija
Savene must only be administered intravenously. 
Zdravilo Savene lahko uporabljate le intravensko.
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). 
(mediana 0,34 h), končni razpolovni časi izločanja pa 1,9-9,1 h (mediana 2,8 h).
One emergency kit contains 10 vials of Savene powder and 3 bottles of Savene solvent supplied with 3 bottle hangers. 
En komplet za nujno uporabo vsebuje 10 vial praška Savene in 3 steklenice vehikla Savene s 3 obešali za steklenice.
• Dimethylsulfoxide (DMSO) should not be used in patients who are administered dexrazoxane to treat anthracycline extravasation (see section 5.3) 
• Bolniki, ki za zdravljenje antraciklinske ekstravazacije prejmejo deksrazoksan, ne smejo prejeti dimetilsulfoksida (DMSO) (glejte poglavje 5.3).
Savene powder for concentrate Solvent for Savene 
prašek za koncentrat Savene vehikel Savene
It is not known whether dexrazoxane is excreted in human milk. 
Ni znano, ali se deksrazoksan izloča v materino mleko.
Each ml contains 20 mg of dexrazoxane after reconstitution with 25 ml of Savene solvent. 
En ml vsebuje 20 mg deksrazoksana po rekonstituciji s 25 ml vehikla Savene.
• Weight loss, loss of appetite 
• izguba telesne mase, izguba teka,
METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use after reconstitution and dilution. 
POSTOPEK IN POT(I) UPORABE ZDRAVILA Intravenska uporaba po rekonstituciji in redčenju.
Skin reactions have been reported following contact with dexrazoxane. 
Po stiku z deksrazoksanom so poročali o kožnih reakcijah.
Adverse reactions reported are listed according to the following frequency: 
Pogostnost neželenih učinkov je opisana sledeče:
- The other ingredient(s) are: The solvent which contains sodium chloride, potassium chloride, magnesium chloride hexahydrate, sodium acetate trihydrate, sodium gluconate, sodium hydroxide and water for injections. 
- Druge sestavine zdravila so: Vehikel, ki vsebuje natrijev klorid, kalijev klorid, magnezijev klorid heksahidrat, natrijev acetat trihidrat, natrijev glukonat, natrijev hidroksid in vodo za injekcije.
Women of child-bearing potential/Contraception in males and females Since dexrazoxane possesses mutagenic activity and is used with anthracyclines known to have cytotoxic, mutagenic and embryotoxic properties, both sexually active men and women of childbearing potential should be advised not to father a child/become pregnant and must use effective contraceptive measures during and up to 6 months after treatment. 
da imajo citotoksične, mutagene in embriotoksične lastnosti, je treba spolno aktivnim moškim in ženskam v rodni dobi svetovati, da ne zaplodijo otroka/zanosijo ter naj uporabljajo učinkovito kontracepcijo med zdravljenjem in do 6 mesecev po njem.
• Reduction in the number of white blood cells and platelets 
• zmanjšano število levkocitov in trombocitov,
Savene powder: Amber-coloured, 36-ml, glass type I vial with stopper made of chlorobutyl rubber and a flip-off cap. 
36 ml viala tipa I jantarne barve z zamaškom iz klorobutilne gume in izvlečno zaporko.
The recommended dose is: Day 1: 1000 mg/m2 
Priporočeni odmerek je: prvi dan: 1.000 mg/m2 drugi dan: 1.000 mg/m2
Savene is available as an emergency kit consisting of 10 vials of Savene powder and 3 bottles of Savene solvent supplied with 3 bottle hangers. 
Zdravilo Savene je na voljo v kompletu za nujno uporabo z 10 vialami praška Savene in 3 steklenicami vehikla Savene s 3 obešali za steklenice.
Clear isotonic solution (295 mOsml/l, pH approx. 7.4). 
Steklenica z vehiklom: bistra izotonična raztopina (295 mOsml/l, pH pribl.
Powder vial: 
Viala s praškom:
Dexrazoxane has minor influence on the ability to drive and use machines. 
Deksrazoksan ima blag vpliv na sposobnost vožnje in upravljanja s stroji.
No of patients with post baseline value 
Št. bolnikov s preiskavo po izhodiščni vrednosti
For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3. 
Za pogoje shranjevanja po rekonstituciji ali redčenju zdravila glejte poglavje 6.3. 6.5 Vrsta ovojnine in vsebina
Each vial contains 500 mg dexrazoxane (589 mg dexrazoxane hydrochloride). 
Ena viala vsebuje 500 mg deksrazoksana (589 mg deksrazoksan klorida).
OTHER SPECIAL WARNING(S), IF NECESSARY Contains cytotoxics after dilution with concentrate. 
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Po redčenju koncentrata v vehiklu vsebuje citotoksike.
Dexrazoxane is not recommended in combination with phenytoin. 
Deksrazoksan ni priporočljiv ob sočasnem zdravljenju s fenitoinom.
What Savene looks like and contents of the emergency kit The Savene kit consists of Savene powder for concentrate (white to off-white powder) and Savene solvent. 
Komplet zdravila Savene je sestavljen iz (belega do umazano belega) praška za koncentrat Savene in vehikla Savene.