FrancophonIA/ELRC3.0 huggingface dataset:
English: Savene will be given by infusion into one of your veins.
Croatian: Savene će Vam biti dan infuzijom u jednu od vena.
English: 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.
Croatian: Obratite se svom liječniku ili medicinskoj sestri prije nego uzmete Savene: - Savene Vam se treba dati samo ako ste imali ekstravazaciju povezanu s terapijom koja sadrži antraciklin.
English: The first and second doses were 1000 mg/m2 and the third was 500 mg/m2.
Croatian: Prva i druga doza bile su 1000 mg/m2 a treća je bila 500 mg/m2.
English: Cenexi-Laboratoires Thissen SA Rue de la Papyrée 2-4-6 B-1420 Braine-L'Alleud Belgium
Croatian: Rue de la Papyrée 2-4-6 B-1420 Braine-L'Alleud Belgija
English: Safety and efficacy have not been evaluated in the elderly and the use of dexrazoxane in such patients is not recommended.
Croatian: Nisu procijenjene sigurnost i djelotvornost u starijih osoba te se uporaba deksrazoksana ne preporučuje u takvih bolesnika.
English: The treatment is considered to have a limited influence on the ability to drive and use machines.
Croatian: Smatra se da terapija ima ograničeni utjecaj na sposobnost upravljanja vozilima i strojevima.
English: Very common: may affect more than 1 in 10 people
Croatian: Vrlo česte: mogu se pojaviti u više od 1 korisnika na njih 10
English: Concomitant use contraindicated: Yellow fever vaccine: Risk of fatal generalised vaccinial disease (see section 4.3).
Croatian: Kontraindicirana je istodobna uporaba s: cjepivom za žutu groznicu: rizik od smrtonosne generalizirane vakcinalne bolesti (vidjeti dio 4.3).
English: The concentrate is slightly yellow.
Croatian: Koncentrat je žućkast.
English: Interactions common to all cytotoxics:
Croatian: Interakcije koje su uobičajene za sve citotoksične lijekove:
English: Women must inform their doctor immediately if they become pregnant (see section 4.3 and 4.6).
Croatian: Žene moraju odmah obavijestiti svojeg liječnika ako zatrudne (vidjeti dijelove 4.3 i 4.6).
English: Chelation of iron, especially through its ring-opened metabolite thus reducing the irondependent oxidative stress causing anthracycline-induced cardiotoxicity.
Croatian: Kelacija željeza, posebno putem njegovog prstenasto otvorenog metabolita, tako smanjujući oksidativni stres ovisan o željezu koji dovodi do kardiotoksičnosti uzrokovane antraciklinom.
English: Concomitant use to assess carefully: Ciclosporin, tacrolimus: Excessive immunosuppression with risk of lymphoproliferative disease.
Croatian: Pažljivo procijeniti istovremenu uporabu sa sljedećim: ciklosporin, takrolimus: prekomjerna imunosupresija s rizikom od limfoproliferativne bolesti.
English: If the powder or solution contacts the skin or mucous membranes, wash immediately and thoroughly with water.
Croatian: Ako prašak ili otopina dođu u kontakt s kožom ili sluznicom, isperite ih odmah i temeljito s vodom.
English: There is limited evidence from studies that suggests epirubicin clearance may be increased when dexrazoxane is pre-administered, this occurred at high doses of epirubicin (120-135 mg/m2).
Croatian: Postoje ograničeni dokazi iz ispitivanja koji upućuju na to da se klirens epirubicina može povećati ako je deksrazoksan prethodno primijenjen, što se pojavilo pri visokim dozama epirubicina (120-135 mg/m2).
English: • Phenytoin: cytotoxic agents may reduce the absorption of phenytoin leading to an exacerbation of convulsions.
Croatian: • Fenitoin: citotoksične tvari mogu smanjiti apsorpciju fenitoina što može dovesti do pogoršanja konvulzija.
English: Savene must only be administered intravenously.
Croatian: Savene se mora davati isključivo intravenski.
English: Savene solvent also contains 1.61 g sodium (main component of cooking/table salt) in each 500 ml bottle.
Croatian: Otapalo lijeka Savene također sadrži 1,61 g natrija (glavni sastojak kuhinjske/stolne soli) u svakoj boci od 500 ml.
English: 3.1.4 Allow the vial with the concentrate to stand for 5 minutes at room temperature and check if the solution is homogenous and clear.
Croatian: 3.1.4 Ostavite koncentrat u bočici 5 minuta pri sobnoj temperaturi i provjerite je li otopina homogena i bistra.
English: How to use Savene
Croatian: Kako čuvati Savene
English: The related razoxane has been demonstrated to be embryotoxic in mice, rats and rabbits and teratogenic in rats and mice.
Croatian: Srodni razoksan pokazao se embriotoksičan u miševa, štakora i zečeva te teratogen u štakora i miševa.
English: Women must inform their doctor immediately if they become pregnant (see section 4.3).
Croatian: Žene moraju odmah obavijestiti svojeg liječnika ako zatrudne (vidjeti dio 4.3).
English: The first infusion will be given as soon as possible and within the first six hours after extravasation of an anthracycline medicine.
Croatian: Prva infuzija će biti dana što je moguće prije i unutar prvih šest sati nakon ekstravazacije lijeka antraciklina.
English: Use an inactivated vaccine where this exists (poliomyelitis).
Croatian: Upotrijebite inaktivno cjepivo u tim slučajevima (poliomijelitis)
English: Myelosuppression is thus common.
Croatian: Zbog toga je česta mijelosupresija.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/350/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/06/350/001
English: Bibliographical data demonstrate that serum kinetics of dexrazoxane after intravenous administration follow an open two-compartment model independent of schedule and dose.
Croatian: Bibliografski podaci pokazuju da kinetika deksrazoksana u serumu nakon intravenske primjene slijedi otvoreni model s dva odjeljka neovisan o rasporedu i dozi.
English: If you receive more Savene than you should, you will be closely monitored with specific attention to your blood cells, potential gastro-intestinal signs, skin reactions and hair loss.
Croatian: Ako primite više lijeka Savene nego što trebate, bit ćete pod stalnim nadzorom posebno prateći Vaše krvne stanice, moguće probavne znakove, kožne reakcije i gubitak kose.
English: • Women of childbearing potential not using contraceptive measures (see section 4.6).
Croatian: • Žene u reproduktivnoj dobi koje ne upotrebljavaju kontracepciju (vidjeti dio 4.6).
English: Concomitant use not recommended:
Croatian: Ne preporučuje se istovremena uporaba s:
English: • Difficulties in breathing
Croatian: • Otežano disanje
English: • Dexrazoxane may add to the toxicity induced by the chemotherapy cycle during which the accident took place, requiring careful monitoring of haematological parameters (see section 4.4).
Croatian: • Deksrazoksan može povećati toksičnost izazvanu ciklusom kemoterapije tijekom koje je došlo do nezgode, što zahtijeva pažljivo praćenje hematoloških parametara (vidjeti dio 4.4).
English: Patients treated with anticoagulants should be monitored more frequently as cytotoxic agents may interact with oral anticoagulants.
Croatian: Bolesnike koji primaju lijekove protiv zgrušavanja treba češće nadzirati jer citotoksične tvari mogu imati interakciju s oralnim antikoagulansima.
English: Initial elimination half lives (alpha) are 0.18-1 h (median 0.34 h) and terminal elimination half lives 1.9-9.1 h (median 2.8 h).
Croatian: Početno poluvrijeme eliminacije (alfa) iznosi 0,18-1 h (medijan 0,34 h), a završno poluvrijeme eliminacije 1,9-9,1 h (medijan 2,8 h).
English: 3.1.5 Keep and store the opened solvent bottle under aseptic conditions because it is needed for dilution of the concentrate.
Croatian: 3.1.5 Otvorenu bocu s otapalom pohranite u aseptičkim uvjetima jer je potrebna za razrjeđivanje koncentrata.
English: The aim was to examine the pharmacokinetics of a 3-day dosing regimen of dexrazoxane and its efficacy in patients for anthracycline extravasation.
Croatian: Cilj je bio pregledati farmakokinetiku trodnevnog režima doziranja deksrazoksana i njegovu djelotvornost u bolesnika kod ekstravazacije antraciklina.
English: 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.
Croatian: Povremeno može doći do nezgode te se lijek primijeni izvan vene u okolno tkivo ili curi iz vene u okolno tkivo.
English: Healthcare professionals are asked to report any suspected adverse reaction via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava: navedenog u
English: It can reduce the amount of tissue damage caused by anthracycline extravasation.
Croatian: Može smanjiti oštećenje tkiva koje uzrokuje ekstravazacija antraciklina.
English: The concentrate should then be diluted further in the remaining Savene solvent.
Croatian: Nakon toga koncentrat treba dodatno razrijediti u preostalom otapalu lijeka Savene.
English: Co-administration of doxorubicin (50 to 60 mg/m2) or epirubicin (60 to 100 mg/m2) did not affect dexrazoxane pharmacokinetics significantly.
Croatian: Istodobna primjena doksorubicina (50 do 60 mg/m2) ili epirubicina (60 do 100 mg/m2) nije značajno utjecala na farmakokinetiku deksrazoksana.
English: Clear isotonic solution (295 mOsml/l, pH approx. 7.4).
Croatian: Bistra izotonična otopina (295 mOsml/l, pH približno 7,4).
English: Since Savene will be administered to patients undergoing cytotoxic therapy with anthracyclines its cytotoxic potential (especially resulting in reversible haematological toxicity with a nadir occurring on days 11-12) will therefore add to that of the other chemotherapy administered.
Croatian: S obzirom da će se Savene davati bolesnicima koji primaju citotoksičnu terapiju antraciklinima, njegov će se citotoksični potencijal (osobito rezultirajući reverzibilnom hematološkom toksičnošću s najnižom vrijednosti 11.-12. dan) zbrojiti s onim od druge primijenjene kemoterapije.
English: The steady-state volume of distribution of dexrazoxane was 30.5 L ± 11.1 for day 1 and 35.8 L ± 19.7 for day 2.
Croatian: Volumen distribucije u stanju dinamičke ravnoteže deksrazoksana bio je 30,5 l ± 11,1 za prvi dan te 35,8 l ± 19,7 za drugi dan.
English: - If the medicine is not used immediately, it should be kept at a temperature of 2 to 8 °C (in the refrigerator) and no longer than 4 hours.
Croatian: - Ako se lijek ne upotrijebi odmah, treba ga čuvati pri temperaturi od 2 do 8 °C (u hladnjaku)
English: The terminal elimination half-life was consistent throughout days 1 - 3 (2.1 - 2.2 h).
Croatian: Terminalno poluvrijeme eliminacije bilo je dosljedno od prvog do trećeg dana (2,1 - 2,2 h).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28 July 2006
Croatian: Datum prvog odobrenja: 28. srpnja 2006.
English: You will receive your infusion once daily for 3 consecutive days.
Croatian: Učestalost primjene Infuziju ćete primati jednom dnevno, 3 uzastopna dana.
English: The following information is based on two clinical studies, TT01 and TT02, of Savene administered to extravasation patients already receiving cycles of chemotherapeutic agents.
Croatian: Sljedeći podaci se temelje na dva klinička ispitivanja, TT01 i TT02, o primjeni lijeka Savene u bolesnika s ekstravazacijom koji već primaju kemoterapijske cikluse.
English: You must not breast-feed while you are treated with Savene.
Croatian: Ne smijete dojiti dok se liječite lijekom Savene.
English: There are no data from the use of dexrazoxane in pregnant women.
Croatian: Ne postoje podaci o korištenju deksrazoksana tijekom trudnoće.
English: 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.
Croatian: Glavna svrha svakog ispitivanja je bila ispitati djelotvornost intravenski primijenjenog lijeka Savene u sprječavanju oštećenja tkiva pri slučajnoj ektravazaciji antraciklina, sprječavajući tako podvrgavanje bolesnika rutinskom kirurškoj eksciziji zahvaćenog tkiva.
English: 3.2.4 Savene should be administered aseptically as a 1-2 hours infusion under room temperature and normal light conditions.
Croatian: 3.2.4 Savene treba primijeniti aseptički kao infuziju koja traje 1-2 sata pri sobnoj temperaturi uz uobičajene uvjete osvjetljenja.
English: When mice with experimental daunorubicin extravasation were treated with dexrazoxane systemically combined with topical treatment with DMSO on the daunorubicin-affected skin area, 67 % of the mice developed small skin wounds, whereas dexrazoxane treatment alone completely prevented the daunorubicin-induced skin necrosis in another group of mice.
Croatian: Kad se miševe s eksperimentalnom ekstravazacijom daunorubicina sistemski liječilo deksrazoksanom u kombinaciji s lokalnom primjenom DMSO-a na područje kože zahvaćeno daunorubicinom, kod 67% miševa pojavile su se male rane na koži, dok se kod druge grupe miševa, gdje je primijenjen samo deksrazoksan, u potpunosti spriječeno pojavljivanje nekroze izazvane daunorubicinom.
English: In-vitro studies on dexrazoxane in human microsomes have shown high stability of dexrazoxane indicating that major metabolism via cytochrome P450 is unlikely.
Croatian: In-vitro ispitivanja deksrazoksana na ljudskim mikrosomima su pokazala njegovu visoku stabilnost što ukazuje na to da je mala vjerojatnost da se glavni metabolizam odvija putem citokroma P450.
English: • Due to an increased thrombotic risk in patients with malignant diseases, the use of anticoagulants treatment is frequent.
Croatian: • zbog povećanog rizika od tromboze u bolesnika oboljelih od malignih bolesti, česta je uporaba lijekova protiv zgrušavanja.
English: - If you have kidney problems, your doctor will monitor for signs of changes to your blood cells.
Croatian: - Ako imate problema s bubrezima, Vaš će liječnik pratiti znakove promjena krvnih stanica.
English: • Concomitant vaccination with yellow fever vaccine (see section 4.5).
Croatian: • Istovremeno cijepljenje cjepivom protiv žute groznice (vidjeti dio 4.5).
English: Adverse reactions observed in the two studies are listed below.
Croatian: U nastavku su navedene nuspojave uočene u ta dva ispitivanja.
English: The solution must not be mixed with any other medicines.
Croatian: Otopina se ne smije miješati s drugim lijekovima.
English: Dizziness, tiredness and sudden fainting have been reported in a few patients treated with Savene.
Croatian: Omaglica, umor i iznenadna nesvjestica uočeni su u nekoliko bolesnika liječenih lijekom Savene.
English: Plasma potassium level must be closely monitored in patients at risk of hyperkalaemia.
Croatian: Treba pažljivo kontrolirati razinu kalija u plazmi u bolesnika s rizikom od razvoja hiperkalemije.
English: Dexrazoxane should not be administered to pregnant women unless clearly necessary.
Croatian: Deksrazoksan se ne smije davati trudnicama osim ako je jasno neophodno.
English: The Savene solvent contains 98 mg potassium in each 500 ml bottle which may be harmful to people on a low-potassium diet or who have kidney problems.
Croatian: Otapalo lijeka Savene sadrži 98 mg kalija u svakoj boci od 500 ml, koji može biti štetan za bolesnike na prehrani s ograničenjem unosa kalija ili koji imaju problema s bubrezima.
English: For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Croatian: Za upute o rekonstituciji i razrjeđivanju lijeka prije primjene, vidjeti dio 6.6.
English: Patients with neutropenia and thrombocytopenia > CTC grade 1 (Common Toxicity Criteria) have not been included in the clinical studies.
Croatian: Bolesnici s neutropenijom i trombocitopenijom stupnja > 1 prema uobičajenim kriterijima toksičnosti (CTC) nisu bili uključeni u klinička ispitivanja.
English: Since liver dysfunction (increases in transaminases and bilirubin) may occur (especially after doses of above 1 000 mg/m2 dexrazoxane), it is recommended that routine liver function tests be performed before each administration of dexrazoxane in patients with known liver function disorders (see section 4.2).
Croatian: S obzirom da može doći do disfunkcije (porast transaminaza i bilirubina) jetre (osobito nakon doza većih od 1000 mg/m2 deksrazoksana), preporuča se rutinski raditi testove jetrene funkcije prije svakog davanja deksrazoksana bolesnicima koji imaju poznati poremećaj funkcije jetre (vidjeti dio 4.2).
English: Clinical efficacy and safety The clinical programme for Savene (dexrazoxane) included two open, single-arm, multicentre studies.
Croatian: Klinička djelotvornost i sigurnost Klinički program za Savene (deksrazoksan) je uključivao dva otvorena ispitivanja jedne skupine u više centara.
English: The following serious side effect has been reported in patients during treatment with Savene (frequency not known):
Croatian: Sljedeće ozbiljne nuspojave prijavljene su u bolesnika tijekom liječenja lijekom Savene (učestalost nije poznata):
English: The mean elimination half-lives of the one-ring opened metabolite B and metabolite C are 0.9-3.9 h (n=5) and 0.5-0.8 h (n=3),
Croatian: Srednje poluvrijeme eliminacije otvorenog jednoprstenastog metabolita B iznosi 0,9-3,9 h (n=5), a metabolita C 0,5-0,8 h (n=3).
English: If there is suspicion of extravasation by vesicant compounds other than anthracyclines through the same IV access, e.g. vincristine, mitomycin, and vinorelbine, Savene would not be effective against the effects from these compounds.
Croatian: Ako postoji sumnja da je kroz isti intravenski pristup došlo do ekstravazacije drugih spojeva koji izazivaju mjehuriće, a ne antraciklina, primjerice, vinkristina, mitomicina i vinorelbina, Savene neće biti učinkovit u liječenju učinaka tih spojeva.
English: Systemic clearance is independent of dose.
Croatian: Sistemski klirens je neovisan o dozi.
English: • Inflammation in the mouth
Croatian: • Upala u ustima
English: 3.1.3 Remove the syringe and needle and mix manually by repeated inversions until the powder is fully dissolved.
Croatian: 3.1.3 Uklonite štrcaljku i iglu te ručno izmiješajte višekratnim mijenjanjem smjera dok se prašak potpuno ne otopi.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Contains cytotoxics after dilution with concentrate.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Sadrži citotoksične tvari nakon razrjeđivanja koncentrata.
English: Savene is used to treat anthracyline extravasation in adults.
Croatian: Savene se koristi za liječenje ekstravazacije antraciklina u odraslih.
English: Modelling suggested that equivalent exposure (AUC0-inf) could be achieved if dosing were reduced by 50% in subjects with CLCR less than 40 mL/min compared with control subjects (CLCR >80 mL/min) (see section 4.2).
Croatian: Modeliranje pokazuje da bi se istovjetna izloženost (AUC0-inf) mogla postići kad bi se doziranje kod ispitanika s CLCR-om manjim od 40 ml/min smanjilo za 50 % u odnosu na kontrolne ispitanike (CLCR >80 ml/min) (vidjeti dio 4.2).
English: In studies, dexrazoxane did not affect the pharmacokinetics of doxorubicin.
Croatian: U ispitivanjima deksrazoksan nije utjecao na farmakokinetiku doksorubicina.
English: Do not use this medicine after the expiry date which is stated on the carton, powder vial label, and solvent bottle label after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, naljepnici bočice s praškom i naljepnici boce s otapalom iza oznake „Rok valjanosti“.
English: Continuous monitoring Local examination should be performed on a regular basis after treatment until resolution.
Croatian: Nakon liječenja treba redovito raditi lokalni pregled do izlječenja.
English: How to store Savene
Croatian: Kako primjenjivati Savene
English: Compared with normal subjects (creatinine clearance (CLCR) >80 mL/min), exposure was 2- fold greater in subjects with moderate (CLCR of 30 to 50 mL/min) to severe (CLCR <30 mL/min) renal impairment.
Croatian: U usporedbi s normalnim ispitanicima (klirens kreatinina (CLCR) >80 ml/min), izlaganje je bilo dvostruko veće u ispitanika s umjerenim (CLCR od 30 do 50 ml/min) do teškim (CLCR <30 ml/min) oštećenjem funkcije bubrega.
English: Repeat-dose toxicity studies with dexrazoxane have shown that primary target organs were tissues that undergo rapid cell division: bone marrow, lymphoid tissue, testes and digestive tract.
Croatian: Ispitivanja toksičnosti ponavljanih doza s deksrazoksanom pokazala su da su glavni ciljni organi bila tkiva čije se stanice brzo dijele: koštana srž, limfatično tkivo, testisi i probavni trakt.
English: This leaflet was last revised in MM/YYYY
Croatian: Ova uputa je zadnji put revidirana u MM/GGGG Ostali izvori informacija
English: 4.2 After reconstitution and dilution: - Chemical and physical in-use stability after reconstitution and subsequent dilution in the solvent has been demonstrated for 4 hours when stored at 2 to 8 °C.
Croatian: Nakon rekonstitucije i razrjeđivanja: - Kemijska i fizikalna stabilnost u uporabi nakon rekonstitucije i naknadnog razrjeđivanja u otapalu dokazana je tijekom 4 sata ako se čuva na temperaturi od 2 do 8 °C.
English: Infection Neutropenic infection
Croatian: Neutropenijska infekcija
English: 3.1 Reconstitution of Savene powder to prepare a concentrate 3.1.1 Using a syringe fitted with a needle, withdraw aseptically 25 ml from the Savene solvent bottle.
Croatian: 3.1 Rekonstitucija praška Savene za pripremu koncentrata 3.1.1 Koristeći štrcaljku s iglom, aseptički izvucite 25 ml iz boce otapala lijeka Savene.
English: Wound complication
Croatian: Komplikacija rane
English: In patients with moderate to severe renal impairment (creatinine clearance <40 mL/min) the Savene dose should be reduced by 50% (see section 4.4 and 5.2).
Croatian: U bolesnika s umjerenim do teškim oštećenjem funkcije bubrega (klirens kreatinina <40 ml/min), potrebno je smanjiti dozu lijeka Savene za 50 % (vidjeti dio 4.4. i 5.2).
English: To be used within 4 hours after dilution when stored at 2-8 °C.
Croatian: Mora se upotrijebiti unutar 4 sata nakon razrjeđivanja, kada se čuva pri temperaturi od 2 do 8 °C.
English: 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).
Croatian: Nuspojave su bile tipične za standardnu kemoterapiju i deksrazoksan: mučnina/povraćanje u oko trećine bolesnika, neutropenija i trombocitopenija u oko polovine bolesnika te puno rjeđe povišena koncentracija jetrenih enzima (ALT/AST).
English: Incidence of adverse reactions (MedDRA) in studies TT01 and TT02 (n=80 patients) (Note that numbers for Blood and Lymphatic System Disorders are described in a separate table of laboratory examinations)
Croatian: Incidencija nuspojava (MedDRA) u ispitivanjima TT01 i TT02 (n=80 bolesnika) (Uočite da su brojevi za poremećaje krvožilnog i limfnog sustava opisani u posebnoj tablici laboratorijskih ispitivanja)
English: This must be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
Croatian: To treba uzeti u obzir u bolesnika sa smanjenom funkcijom bubrega ili u bolesnika na prehrani s ograničenjem unosa kalija.
English: Dexrazoxane has not been studied in patients with impaired hepatic function and its use in such patients is not recommended (see section 4.4).
Croatian: Deksrazoksan nije ispitan u bolesnika s oštećenjem funkcije jetre i njegova se uporaba u takvih bolesnika ne preporučuje (vidjeti dio 4.4).
English: 3.1.2 Inject the entire contents of the syringe into the vial containing the Savene powder.
Croatian: 3.1.2 Ubrizgajte sav sadržaj štrcaljke u bočicu s praškom Savene.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING KIT BOX (1 KIT CONSISTING OF 10 POWDER VIALS AND 3 SOLVENT BOTTLES)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA SETA (1 SET SADRŽI 10 BOČICA PRAŠKA I 3 BOCE OTAPALA)