FrancophonIA/ELRC3.0 huggingface dataset:
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).
Croatian: Dostupni su ograničeni podaci o plodnosti iz ispitivanja na životinjama, no nakon ponavljanih doza u štakora i kunića uočene su promjene na testisima (vidjeti dio 5.3).
English: • Inflammation of the blood vessel where the treatment is given (phlebitis)
Croatian: • Upala krvne žile u koju je ubrizgan lijek (flebitis)
English: If you are sexually active, you are advised to use effective birth control to prevent pregnancy during and for six months after treatment, whether you are male or female (see section 2 ‘Do not use Savene').
Croatian: Ako ste spolno aktivni, savjetuje Vam se primjena učinkovite kontracepcije kako bi se spriječila trudnoća tijekom liječenja i šest mjeseci nakon liječenja, bez obzira na to jeste li muškarac ili žena
English: Concentrate and diluted solution may be stored at 2 to 8 °C for 4 hours.
Croatian: Koncentrat i razrijeđena otopina mogu se čuvati 4 sata na temperaturi od 2 do 8 °C.
English: Caution must be exercised during reconstitution and dilution and the normal procedures for proper handling of cytotoxic medicinal products should be adopted.
Croatian: Morate biti oprezni prilikom rekonstitucije i razrjeđivanja te trebate primjenjivati uobičajene postupke za ispravno rukovanje citotoksičnim lijekovima.
English: 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.
Croatian: 3.2 Razrjeđivanje koncentrata 3.2.1 Kako bi se dobila doza potrebna za bolesnika, može biti nužno upotrijebiti do četiri bočice s koncentratom lijeka Savene.
English: The concentrate contains 20 mg dexrazoxane per ml and should be used immediately for further dilution.
Croatian: Koncentrat sadrži 20 mg deksrazoksana po ml i treba ga odmah dodatno razrijediti.
English: Other possible side effects are listed below:
Croatian: Druge moguće nuspojave navedene su u nastavku:
English: There are limited fertility data from animal studies available, but testicular changes were observed in rats and rabbits following repeat dosing.
Croatian: Dostupni su ograničeni podaci o plodnosti iz ispitivanja na životinjama, no nakon ponavljanih doza u štakora i kunića uočene su promjene na testisima.
English: What Savene contains - The active substance is dexrazoxane.
Croatian: Što Savene sadrži - Djelatna tvar je deksrazoksan.
English: Adverse reactions reported are listed according to the following frequency:
Croatian: Zabilježene nuspojave su navedene prema sljedećoj učestalosti:
English: In both studies dexrazoxane treatment prevented the development of necrosis, allowed cancer treatment to continue as scheduled in the majority of patients (70.4 %), and reduced the occurrence of sequelae (only few and mild long-term sequelae were observed).
Croatian: U oba ispitivanja, kod većine bolesnika (70,4%) liječenje deksrazoksanom spriječilo je razvoj nekroze, omogućilo nastavak planiranog liječenja raka te smanjilo pojavu sekvele (uočeno je samo nekoliko blagih dugotrajnih sekvela).
English: Clinical trial TT04 was conducted on 6 female patients undergoing treatment for anthracycline extravasations.
Croatian: Kliničko ispitivanje TT04 provedeno je na šest bolesnica koje su primale terapiju kod ekstravazacije antraciklina.
English: Interaction specific to dexrazoxane:
Croatian: Interakcije specifične za deksrazoksan:
English: Savene will be given to you under the control of a doctor experienced in the use of anti-cancer treatments.
Croatian: Savene će Vam biti dan pod nadzorom liječnika iskusnog u liječenju raka.
English: Savene is an anti-cancer agent and the normal procedures for proper handling and disposal of anticancer medicines should be adopted, namely: - Personnel should be trained to reconstitute the medicine - Pregnant staff should be excluded from working with this medicine - Personnel handling this medicine during reconstitution should wear protective clothing including mask, goggles and gloves - Accidental contact with the skin or eyes should be treated immediately and thoroughly with copious amounts of water
Croatian: - osoblje treba proći obuku za rekonstituciju lijeka - trudne radnice ne smiju rukovati ovim lijekom - osoblje koje rukuje ovim lijekom tijekom rekonstitucije treba nositi zaštitnu odjeću, uključujući masku, naočale i rukavice - u slučaju nehotičnog kontakta s kožom ili očima, potrebno ih je odmah i temeljito isprati obilnim količinama vode
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.
Croatian: Prašak Savene mora se rekonstituirati u 25 ml otapala lijeka Savene radi dobivanja koncentrata koji se mora dodatno razrijediti u preostalom otapalu lijeka Savene prije primjene.
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).
Croatian: Zbog potencijalnih ozbiljnih nuspojava u dojenih beba izloženih deksrazoksanu, tijekom liječenja lijekom Savene dojenje je kontraindicirano (vidjeti dio 4.3).
English: • Feeling tired, feeling sleepy, feeling dizzy, sudden fainting
Croatian: • Osjećaj umora, osjećaj pospanosti, osjećaj vrtoglavice, nagla nesvjestica
English: For study purposes, patients with extravasations from a central venous access device (CVAD) were not included in the efficacy evaluation.
Croatian: U svrhu ispitivanja, u procjenu učinkovitosti nisu bili uključeni bolesnici s ektravazacijom iz katetera za centralni venski pristup (CVK).
English: • Pneumonia (lung infection)
Croatian: • Upala pluća (plućna infekcija)
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)).
Croatian: S obzirom da se zbog disfunkcije bubrega može smanjiti brzina eliminacije deksrazoksana, bolesnike koji već imaju oštećenu funkciju bubrega treba pratiti kako bi se uočili znakovi hematološke toksičnosti (vidjeti dio 4.2 za preporuke za doziranje u bolesnika s umjerenim do teškim oštećenjem funkcije bubrega (klirens kreatinina <40 ml/min)).
English: Dyspnoea Pneumonia
Croatian: Dispneja Upala pluća
English: Savene solvent contains 98 mg potassium per 500 ml bottle.
Croatian: Otapalo lijeka Savene sadrži 98 mg kalija po boci od 500 ml.
English: Superficial thrombophlebitis Venous thrombosis limb
Croatian: Površinski tromboflebitis Venska tromboza uda
English: UNIQUE IDENTIFIER - 2D BARCODE <Not applicable.>
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD
English: Savene must be administered under the supervision of a physician experienced in the use of anticancer medicinal products.
Croatian: Savene se mora primjenjivati pod nadzorom liječnika s iskustvom u uporabi antitumorskih lijekova.
English: - Phenytoin (a treatment against seizures) (Savene may reduce the effectiveness of this medicine).
Croatian: - Lijek DMSO (to je krema za liječenje nekih kožnih bolesti) - Fenitoin (terapija protiv napadaja) (Savene može smanjiti djelotvornost ovog lijeka).
English: OTHER SPECIAL WARNING(S), IF NECESSARY To be administered under the supervision of a physician experienced in the use of cytotoxic agents.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Mora se primjenjivati uz nadzor liječnika s iskustvom u uporabi citotoksičnih lijekova.
English: Day 3: 500 mg/m2
Croatian: Treći dan: 500 mg/m2
English: Dexrazoxane has been shown to possess mutagenic activity.
Croatian: Deksrazoksan pokazuje mutagenu aktivnost.
English: Based on the required dose for the patient expressed in mg, withdraw aseptically the corresponding volume containing 20 mg dexrazoxane per ml from the appropriate number of vials containing concentrate.
Croatian: Ovisno o potrebnoj dozi za bolesnika izraženoj u mg, aseptički izvucite odgovarajući volumen s 20 mg deksrazoksana po ml iz odgovarajućeg broja bočica s koncentratom.
English: In study TT01, 23 patients were entered and received treatment with Savene.
Croatian: U ispitivanje TT01 uključena su 23 bolesnika koji su primili terapiju lijekom Savene.
English: Previous history of allergy to dexrazoxane should be carefully considered prior to administration (see section 4.3).
Croatian: Prije primjene treba temeljito razmotriti povijest alergija na deksrazoksan (vidjeti dio 4.3).
English: Solvent bottle:
Croatian: Boca s otapalom:
English: 3.2.2 Inject the required volume back into the opened Savene solvent bottle (see point 3.1.5).
Croatian: 3.2.2 Ubrizgajte odgovarajući volumen natrag u otvorenu bocu otapala lijeka Savene (vidjeti stavku
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.
Croatian: Međutim, zabilježeno je da je razoksan (racemična smjesa deksrazoksana i levrazoksana) povezan s razvojem zloćudnih tumora u miševa (limfatičke neoplazme) i štakora (karcinomi maternice) nakon dulje primjene.
English: Signs and symptoms of overdosage are likely to consist of leucopenia, thrombocytopenia, nausea, vomiting, diarrhoea, skin reactions and alopecia.
Croatian: Znakovi i simptomi predoziranja najčešće su leukopenija, trombocitopenija, mučnina, povraćanje, dijareja, reakcije na koži i alopecija.
English: In study TT02, 57 patients entered the study and received the first dose of Savene.
Croatian: U ispitivanjeTT02 uključeno je 57 bolesnika koji su primili prvu dozu lijeka Savene.
English: 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.
Croatian: Žene u reproduktivnoj dobi / kontracepcija kod muškaraca i žena Budući da deksrazoksan ima mutagenu aktivnost i da se upotrebljava s antraciklinima za koje se zna da imaju citotoksična, mutagena i embriotoksična svojstva, spolno aktivnim muškarcima i ženama u reproduktivnoj dobi mora se savjetovati da ne začnu dijete / da ne zatrudne i da upotrebljavaju učinkovite kontraceptivne mjere tijekom liječenja i do šest mjeseci nakon liječenja.
English: Incidence of laboratory abnormalities in TT01 and TT02 (n=80 patients) Lab test
Croatian: Incidencija odstupanja u rezultatima laboratorijskih testova u ispitivanjima TT01 i TT02 (n=80 bolesnika)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING SOLVENT BOTTLE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU BOCA OTAPALA
English: 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.
Croatian: Kao što je opisano u nekoliko ispitivanja, vjerojatno je kelirajuće svojstvo odgovorno za povećano izlučivanje željeza i cinka u urinu te za smanjenje serumske koncentracije kalcija.
English: 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.
Croatian: 3.2.5 Kao i kod svih parenteralnih lijekova, prije primjene potrebno je vizualno provjeriti ima li u koncentratu lijeka Savene i otopini infuzije čestica i je li došlo do promjene boje.
English: • Swelling in arms or legs (oedema)
Croatian: • Oticanje ruku i nogu (edem)
English: Calcium Total (Hypo)
Croatian: Ukupni kalcij (snižen)
English: 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.
Croatian: Savene je dostupan kao set za hitne slučajeve koji sadrži 10 bočica praška Savene i 3 boce otapala lijeka Savene koji se isporučuje s tri vješalice za boce.
English: Chemical and physical in-use stability has been demonstrated for 4 hours when stored at 2 to 8 °C.
Croatian: Kemijska i fizikalna stabilnost u uporabi dokazana je tijekom 4 sata ako se čuva na temperaturi od 2
English: 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.
Croatian: Set lijeka Savene sadrži Savene prašak za koncentrat (bijeli do bjelkasti prah) i otapalo lijeka Savene.
English: Excipients with known effects: Solvent bottle:
Croatian: Pomoćne tvari s poznatim učinkom:
English: Skin reactions have been reported following contact with dexrazoxane.
Croatian: Nakon kontakta s deksrazoksanom prijavljene su reakcije na koži.
English: Day 2: 1000 mg/m2
Croatian: Drugi dan: 1000 mg/m2
English: Most common adverse reactions are nausea/vomiting, bone marrow suppression (neutropenia, thrombocytopenia), injection site reactions, diarrhoea, stomatitis and increase in hepatic transaminases (ALT/AST).
Croatian: Najčešće nuspojave su mučnina/povraćanje, supresija koštane srži (neutropenija, trombocitopenija), reakcije na mjestu uboda injekcije, dijareja, stomatitis i porast jetrenih transaminaza (ALT/AST).
English: 3.2.3 Mix the solution by agitating gently the infusion bottle.
Croatian: 3.2.3 Miješajte otopinu laganim miješanjem boce infuzije.
English: Marketing Authorisation Holder Clinigen Healthcare B.V.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet i proizvođač Nositelj odobrenja za stavljanje lijeka u promet Clinigen Healthcare B.V.
English: • Dimethylsulfoxide (DMSO) should not be used in patients who are administered dexrazoxane to treat anthracycline extravasation (see section 5.3)
Croatian: • U bolesnika kojima se za liječenje ekstravazacije antraciklina daje deksrazoksan, ne smije se upotrebljavati dimetilsulfoksid (DMSO) (vidjeti dio 5.3)
English: Anaphylactic reaction including angioedema, skin reactions, bronchospasm, respiratory distress, hypotension and loss of consciousness have been observed in patients treated with dexrazoxane and anthracyclines (see section 4.8).
Croatian: U bolesnika liječenih deksrazoksanom i antraciklinima uočena je anafilaktička reakcija uključujući angioedem, reakcije na koži, bronhospazam, respiratorni distres, hipotenziju i gubitak svijesti (vidjeti dio 4.8).
English: One emergency kit contains 10 vials of Savene powder and 3 bottles of Savene solvent supplied with 3 bottle hangers.
Croatian: Set za hitne slučajeve sadrži 10 bočica praška Savene i 3 boce otapala lijeka Savene isporučene s tri vješalice za boce.
English: • Dry mouth
Croatian: Stomatitis Suha usta
English: Injection site phlebitis Injection site erythema Fatigue
Croatian: Flebitis na mjestu injiciranja Eritem na mjestu injiciranja
English: Dexrazoxane may cause foetal harm when administered to pregnant women.
Croatian: Deksrazoksan može izazvati oštećenja ploda ako se primjenjuje u trudnica.
English: Note that in these studies dexrazoxane was administered prior to anthracyline administration.
Croatian: Potrebno je napomenuti da je u ovim ispitivanjima deksrazoksan primijenjen prije primjene antraciklina.
English: Savene is indicated in adults for the treatment of anthracycline extravasation.
Croatian: Savene je indiciran u odraslih osoba za liječenje ekstravazacije antraciklina.
English: Before infusion, Savene powder must be reconstituted with 25 ml Savene solvent to give a concentration of 20 mg dexrazoxane per ml.
Croatian: Prije infuzije, prašak Savene mora se rekonstituirati s 25 ml otapala lijeka Savene kako bi se dobila koncentracija od 20 mg deksrazoksana po ml.
English: Use a graduated syringe filled with a needle.
Croatian: Upotrijebite štrcaljku s oznakama volumena na kojoj je igla.
English: Common: may affect up to 1 in 10 people
Croatian: Česte: mogu se pojaviti u do 1 korisnika na njih 10 • Povraćanje
English: Savene contains the active substance dexrazoxane, which acts as an antidote to anti-cancer medicines called anthracyclines.
Croatian: Što je Savene i za što se koristi Savene sadrži djelatnu tvar deksrazoksan koja djeluje kao protulijek za antikancerogene lijekove antracikline.
English: The preparation should not be handled by pregnant staff.
Croatian: Trudne radnice ne smiju rukovati pripravkom.
English: Do not use Savene: - If you are allergic to dexrazoxane or any of the other ingredients of this medicine (listed in section 6) - If you are planning to become pregnant and do not use adequate contraceptive measures - If you are breast-feeding - If you are given yellow-fever vaccine
Croatian: Što morate znati prije nego počnete primjenjivati Savene Nemojte uzimati Savene: - ako ste alergični na deksrazoksan ili neki drugi sastojak ovog lijeka (naveden u dijelu 6) - ako planirate ostati trudni i ne primjenjujete odgovarajuće kontraceptivne mjere
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 mg dexrazoxane
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 500 mg deksrazoksana
English: - 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.
Croatian: - Drugi sastojci su: Otapalo koje sadrži natrijev klorid, kalijev klorid, magnezijev klorid heksahidrat, natrijev acetat trihidrat, natrijev glukonat, natrijev hidroksid i vodu za injekcije.
English: After reconstitution with 25 ml Savene solvent, 1 ml of concentrate contains 20 mg dexrazoxane.
Croatian: Nakon rekonstitucije s 25 ml otapala lijeka Savene, 1 ml koncentrata sadrži 20 mg deksrazoksana.
English: Hepatic and renal-function monitoring
Croatian: Praćenje funkcija jetre i bubrega
English: Keep in the outer carton in order to protect from light.
Croatian: Čuvati u vanjskoj kutiji radi zaštite od svjetlosti.
English: Savene powder for concentrate Solvent for Savene
Croatian: Savene prašak za koncentrat otapalo za lijek Savene
English: Savene contains potassium and sodium
Croatian: Sadržaj kalija i natrija
English: • Wound complications
Croatian: • Komplikacije s ranama
English: Dizziness, somnolence and syncope have been reported in a few patients included in Savene studies TT01 and TT02 (see section 4.8).
Croatian: Kod nekoliko bolesnika uključenih u TT01 i TT02 ispitivanja lijeka Savene prijavljene su vrtoglavica, pospanost i sinkopa (vidjeti dio 4.8).
English: Savene solvent also contains 1.61 g sodium per 500 ml bottle, equivalent to 81% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Croatian: Otapalo lijeka Savene također sadrži 1,61 g natrija po boci od 500 ml, što odgovara 81 %
English: Alopecia Pruritus
Croatian: Alopecija
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use after dilution with concentrate.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Za intravensku primjenu nakon razrjeđivanja koncentrata.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS POWDER VIAL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE BOČICA S PRAŠKOM
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use after reconstitution and dilution.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Intravenska primjena nakon rekonstitucije i razrjeđivanja.
English: • Vaginal bleeding
Croatian: • Vaginalno krvarenje
English: The concentration of dexrazoxane following reconstitution with 25 ml Savene solvent is 20 mg/ml.
Croatian: Koncentracija deksrazoksana nakon pripreme s 25 ml otapala lijeka Savene je 20 mg/ml.
English: Vaginal haemorrhage
Croatian: Vaginalno krvarenje
English: PHARMACEUTICAL FORM Powder and solvent for concentrate for solution for infusion.
Croatian: Prašak i otapalo za koncentrat za otopinu za infuziju.
English: Day 1: 1000 mg/m2 Day 2: 1000 mg/m2 Day 3: 500 mg/m2
Croatian: Prvi dan: 1000 mg/m2 Drugi dan: 1000 mg/m2
English: The recommended dose is: Day 1: 1000 mg/m2
Croatian: Preporučena doza za odrasle (s normalnom funkcijom bubrega) je: Prvi dan: 1000 mg/m2
English: Solutions containing a precipitate should be discarded.
Croatian: Otopine s talogom treba baciti.
English: Contains cytotoxics.
Croatian: Sadrži citotoksične tvari.
English: Each vial contains 500 mg dexrazoxane (589 mg dexrazoxane hydrochloride).
Croatian: Jedna bočica sadrži 500 mg deksrazoksana (589 mg deksrazoksanklorida).
English: Preparation guide for use with Savene 20 mg/ml powder and solvent for concentrate for solution for infusion
Croatian: Upute za pripremu za uporabu Savene 20 mg/ml praška i otapala za koncentrat za otopinu za infuziju
English: Your doctor may reduce your dose if you have kidney problems.
Croatian: Treći dan: 500 mg/m2 Liječnik Vam može smanjiti dozu ako imate problema s bubrezima.
English: Dizziness Sensory loss Syncope Tremor
Croatian: Sinkopa Tremor
English: Sodium chloride Potassium chloride Magnesium chloride hexahydrate Sodium acetate trihydrate Sodium gluconate Sodium hydroxide Water for injections
Croatian: natrijev klorid kalijev klorid magnezijev klorid heksahidrat natrijev acetat trihidrat natrijev glukonat natrijev hidroksid voda za injekcije
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.
Croatian: Ukupni rasponi i srednja vrijednost za AUC0-24 tijekom dana bili su vrlo slični.
English: Injection site induration Injection site swelling Peripheral oedema Somnolence
Croatian: Induracija na mjestu injiciranja Oteklina na mjestu injiciranja Periferni edem
English: Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate, Sodium acetate trihydrate, Sodium gluconate, Sodium hydroxide, Water for injections.
Croatian: natrijev klorid, kalijev klorid, magnezijev klorid heksahidrat, natrijev acetat trihidrat, natrijev glukonat, natrijev hidroksid, voda za injekcije.
English: Savene 20 mg/ml powder and solvent for concentrate for solution for infusion Dexrazoxane
Croatian: Savene 20 mg/ml prašak i otapalo za koncentrat za otopinu za infuziju deksrazoksan
English: Sodium (Hypo) Potassium (Hypo) Potassium (Hyper) Alkaline Phosphatase Bilirubin
Croatian: Alkalna fosfataza Bilirubin AST
English: White to off-white lyophilisate.
Croatian: Bočica s praškom: Bijeli do bjelkasti liofilizat.
English: Thus, dimethylsulfoxide (DMSO) should not be used in patients who are administered dexrazoxane to treat anthracycline extravasation.
Croatian: U bolesnika kojima se za liječenje ekstravazacije antraciklina daje deksrazoksan, ne smije se upotrebljavati dimetilsulfoksid (DMSO).
English: Immune system disorders
Croatian: Poremećaji imunološkog sustava Nije poznato
English: LDH
Croatian: Kreatinin LDH
English: Cenexi-Laboratoires Thissen SA Rue de la Papyrée 2-4-6
Croatian: Cenexi-Laboratoires Thissen SA
English: Savene powder: Amber-coloured, 36-ml, glass type I vial with stopper made of chlorobutyl rubber and a flip-off cap.
Croatian: Prašak Savene: Bočica volumena 36 ml, jantarne boje, od stakla tipa
English: Each vial contains 500 mg dexrazoxane as 589 mg dexrazoxane hydrochloride.
Croatian: Jedna bočica sadrži 500 mg deksrazoksana u obliku 589 mg deksrazoksanklorida.
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet Cenexi-Laboratoires Thissen SA
English: Keep vials and bottles in the outer carton in order to protect from light.
Croatian: Bočice i boce čuvati u vanjskoj kutiji radi zaštite od svjetlosti.
English: No of patients with post baseline value
Croatian: Broj bolesnika s vrijednostima nakon početka ispitivanja
English: Savene solvent: 500 ml solution in bottles made of Type-I (Ph.Eur.)
Croatian: 500 ml otopine u staklenim bocama tipa