FrancophonIA/ELRC3.0 huggingface dataset:
English: Zalmoxis is given to prevent a complication of transplantations that are not fully matched known as ‘graft-versus-host disease' whereby the cells of the donor attack the patient's own cells.
Croatian: Zalmoxis se primjenjuje u svrhu sprečavanja komplikacija transplantacija s nepotpunim podudaranjem, poznatim kao „reakcija presatka protiv primatelja“, gdje stanice donora napadaju stanice bolesnika.
English: Once the bag is infused, it is flushed 2 to 3 times with sodium chloride solution in order to completely administer Zalmoxis.
Croatian: Kad je vrećica infundirana, 2 do 3 puta se ispere otopinom natrijeva klorida kako bi se primijenio sav Zalmoxis.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Total cell number: ____x10X
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA Ukupan broj stanica: ____x 10X
English: Undesirable effects recorded in the clinical study TK007 are listed in Table 1 by system organ class and by frequency of occurrence.
Croatian: Nuspojave zabilježene u sklopu kliničkog ispitivanja TK007 navedene su u Tabeli 1 prema organskim sustavima i učestalosti pojavljivanja.
English: Zalmoxis should not be administered if the circulating T lymphocytes are ≥100 per μL at the day of planned infusion after haploidentical HSCT.
Croatian: Zalmoxis se ne smije primjenjivati ako su cirkulirajući T-limfociti ≥100 po µl na dan za kada je planirana infuzija nakon haploidentične HSCT.
English: One individual treatment dose in 50-500 mL ethylene-vinyl-acetate cryo bag, inside a plastic bag and then a metal box.
Croatian: Jedna doza za liječenje pojedinog bolesnika u krio-vrećici od etilenvinilacetata od 50-500 ml, unutar plastične vrećice koja je u metalnoj kutiji.
English: The infusion solution should be used immediately after thawing.
Croatian: Infuzijska otopina mora se primijeniti odmah nakon odmrzavanja.
English: No specific paediatric group has been studied at present.
Croatian: Pedijatrijska populacija Trenutno nema ispitivanja u posebnim pedijatrijskim skupinama.
English: Dispersion for infusion Bag volume:___________mL Dose: 1x107 cells /kg Concentration: _____x10x cells/mL Total cell number: _____x10X
Croatian: Doza: 1 x 107 stanica/kg Koncentracija: _____x 10x stanica/ml Ukupan broj stanica: _____x 10X
English: Zalmoxis contains sodium
Croatian: Zalmoxis sadrži natrij
English: Immune reconstitution defined as circulating T lymphocytes ≥100 per μL at the day of planned infusion after haploidentical HSCT.
Croatian: Imunološka rekonstitucija definirana kao broj cirkulirajućih T-limfocita ≥100 po μl na dan planirane infuzije nakon haploidentične HSCT.
English: Practical information for handling and administration of Zalmoxis for the doctor or nurse can be found at the end of this leaflet.
Croatian: Praktične informacije o rukovanju i primjeni Zalmoxisa za liječnika ili medicinsku sestru pronaći ćete na kraju ove upute o lijeku.
English: • The cryobag and any unused product or waste material contains genetically modified organisms and should be disposed of in accordance with local requirements.
Croatian: • Krio-vrećica kao i neiskorišteni lijek ili otpadni materijal sadrže genetski modificirane organizme te ih je potrebno zbrinuti u skladu s nacionalnim propisima.
English: Immune-reconstituted patients reached a CD3+ cell count ≥ 100/μL at a median of 77 days after
Croatian: Imunološki rekonstituirani bolesnici dosegli su broj CD3+ stanica ≥100/μl u medijanu od 77 dana nakon HSCT-a.
English: Do not infuse Zalmoxis if
Croatian: Nemojte infundirati Zalmoxis ako:
English: Zalmoxis is a patient specific product and should under no circumstances be administered to other patients.
Croatian: Zalmoxis je isključivo lijek za određenog bolesnika i ne smije se ni pod kojim uvjetima primjenjivati u drugih bolesnika.
English: Women of childbearing potential / Contraception in males and females The risk on virus shedding vertical viral transmission is theoretically negligible however not excluded.
Croatian: Rizik izlučivanja virusa i vertikalnog prijenosa virusa je teoretski zanemariv, no ipak se ne isključuje.
English: Shelf life after thawing: 2 hours
Croatian: Rok valjanosti nakon odmrzavanja: 2 sata
English: Zalmoxis is therefore not recommended for use in children and adolescent below 18 years.
Croatian: Stoga se Zalmoxis ne preporučuje za primjenu u djece i adolescenata mlađih od
English: It must not be administered if the following conditions occur: a) infections requiring administration of ganciclovir (GCV) or valganciclovir (VCV) at the time of infusion; b) GvHD requiring systemic immunosupressive therapy; c) ongoing systemic immunosupressive therapy or administration of granulocyte colony stimulating factor (G-CSF) after haploidentical HSCT.
Croatian: a) infekcije koje zahtijevaju primjenu ganciklovira (GCV) ili valganciklovira (VCV) za vrijeme infuzije; b) GvHD koja zahtijeva sustavnu imunosupresivnu terapiju; c) sustavna imunosupresivna terapija ili primjena faktora stimulacije granulocitnih kolonija (G-CSF) koja je u tijeku nakon haploidentične HSCT.
English: Zalmoxis shall not be administered to patients with concurrent systemic immunosuppressive therapy as the efficacy of Zalmoxis treatment in early immune reconstitution may be reduced.
Croatian: Zalmoxis se smije primjenjivati u bolesnika s istodobnom sustavnom terapijom imunosupresivima jer je moguće smanjenje djelotvornosti liječenja lijekom Zalmoxis u ranoj imunološkoj rekonstituciji.
English: Zalmoxis should be administered after a 24-hour discontinuation period of ganciclovir or valganciclovir and immunosuppressive therapy.
Croatian: Zalmoxis treba primijeniti nakon 24-satnog razdoblja prekida terapije ganciklovirom ili valganciklovirom i imunosupresivima.
English: - If you get any side effects, talk to your doctor, or a physician experienced in the medical treatment of blood cancer.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili liječnika s iskustvom u liječenju raka krvi.
English: Zalmoxis has been manufactured specifically for you and cannot be administered to any other patient.
Croatian: Zalmoxis je proizveden isključivo za Vas te njegova primjena nije moguća u drugih bolesnika.
English: Zalmoxis 5-20 x 106 cells/mL cell dispersion for infusion contains 13.3 mmol (305.63 mg) of sodium per dose.
Croatian: Zalmoxis 5-20 x 106 stanica/ml stanična disperzija za infuziju sadrži 13,3 mmol (305,63 mg) natrija po dozi.
English: Via Olgettina 58 20132 Milano Italy
Croatian: MolMed S.p.A. Via Olgettina 58 20132 Milano Italija
English: Zalmoxis was evaluated in a phase I/II clinical study (TK007) in adult patients with haematological malignancies at high risk of relapse who have received a stem-cell transplantation from a human leukocyte antigen (HLA) mismatched (haploidentical) donor.
Croatian: Zalmoxis je ocjenjivan u kliničkom ispitivanju faze I/II (TK007) u odraslih bolesnika s hematološkim zloćudnim bolestima s visokim rizikom od relapsa koji su prošli transplantaciju matičnih stanica od donora nepodudarnog humanog leukocitnog antigena (HLA) (haploidentičnih donora).
English: Patients could be treated with Zalmoxis 24 hours after the antiviral or immunosuppressive therapy discontinuation.
Croatian: Bolesnici se mogu liječiti lijekom Zalmoxis 24 sata nakon prekida terapije antiviroticima ili imunosupresivima.
English: • The outer and intermediate package should be checked to verify the product and patient-specificlabel located on the top of the box and on the intermediate bag.
Croatian: • Vanjsko i intermedijarno pakiranje potrebno je provjeriti kako bi se potvrdilo da se radi o odgovarajućem lijeku i da naljepnica koja se nalazi na gornjoj strani kutije te na intermedijarnoj vrećici odgovara određenom bolesniku.
English: There are no data from the use of Zalmoxis in pregnant women.
Croatian: Nema podataka o primjeni Zalmoxisa u trudnica.
English: In-use storage times and conditions should not exceed 2 hours at room temperature (15 °C - 30 °C).
Croatian: Vrijeme i uvjeti čuvanja ne smiju prelaziti 2 sata pri sobnoj temperaturi (15 °C-30 °C).
English: If you forget to use Zalmoxis
Croatian: Ako ste zaboravili primijeniti Zalmoxis
English: 18 months when stored in liquid nitrogen vapour.
Croatian: 18 mjeseci kad se čuva u pari tekućeg dušika.
English: • Upon completion of washing, the patient specific label on the bag should be removed and adhered to the patient specific file.
Croatian: • Po završetku ispiranja, naljepnicu s podacima o određenom bolesniku koja se nalazi na vrećici potrebno je skinuti i zalijepiti u karton tog bolesnika.
English: Before handling or administering Zalmoxis
Croatian: Upute za rukovanje Prije rukovanja ili primjene Zalmoxisa
English: No implications on the use of Zalmoxis in patients of 65 and older have been established.
Croatian: Zalmoxisa u bolesnika u dobi od 65 godina i starijih.
English: The decision to proceed with the next treament is determined by your physician/doctor and is related to your immune status.
Croatian: Odluku o daljnjem nastavku s liječenjem donosi Vaš liječnik ovisno o Vašem imunološkom sustavu.
English: - Post-transplantation lymphoproliferative disorder (increase in the number of white blood cells in the blood after a transplantation) - Chronic graft-versus-host disease (a complication that can occur after a stem-cell or bone marrow transplantation in which the newly transplanted donor cells attack the patient's body) - Intestinal haemorrage (bleeding in the gut) - Hepatic failure (liver malfunction) - Febrile neutropenia (fever associated with reduction of the number of white blood cells) - Decreased haemoglobin (reduction of the number of red blood cells)
Croatian: Česte nuspojave (mogu se javiti u manje od 1 na 10 osoba) - Post-transplantacijski limfoproliferativni poremećaj (povećanje broja bijelih krvnih stanica u krvi nakon transplantacije) - Kronična reakcija presatka protiv primatelja (komplikacija koja se može javiti nakon transplantacije matičnih stanica ili koštane srži pri kojoj netom transplantirane donorske stanice napadaju tijelo bolesnika) - Intestinalno krvarenje (krvarenje u crijevima) - Zatajenje jetre (oštećenje funkcije jetre)
English: Shelf life and special precautions for storage
Croatian: Rok valjanosti i posebne mjere opreza u vezi čuvanja
English: - If you suffer from graft-versus-host disease which requires the use of medicines to suppress your immune system.
Croatian: - ako bolujete od reakcije presatka protiv primatelja, koja zahtijeva primjenu lijekova za supresiju imunološkog sustava.
English: Zalmoxis is supplied as one individual treatment dose in a 50-500 mL ethylene-vinyl-acetate cryo bags.
Croatian: Zalmoxis se isporučuje kao jedna doza za liječenje pojedinog bolesnika u krio-vrećicama od etilenvinilacetata od 50-500 ml.
English: • Check that the Certificate of Analysis containing the patient identifiers, expiry date and approval for infusion has been received from the Marketing Authorization Holder.
Croatian: • Uvjerite se da je nositelj odobrenja za stavljanje lijeka u promet dostavio certifikat o analizi, koji sadrži identifikatore bolesnika, rok valjanosti i odobrenje za infuziju.
English: Zalmoxis is solely for use as patient specific medicinal product to be administered after HSCT and it is administered by intravenous infusion.
Croatian: Način primjene Zalmoxis je namijenjen isključivo kao lijek za primjenu kod određenog bolesnika nakon HSCT-a, a primjenjuje se intravenskom infuzijom.
English: WHAT ZALMOXIS IS AND WHAT IT IS USED FOR
Croatian: Što se nalazi u ovoj uputi Što je Zalmoxis i za što se koristi Što morate znati prije nego
English: What Zalmoxis looks like and contents of the pack Zalmoxis is a cell dispersion for infusion appearing as opaque, off-white frozen dispersion of cells.
Croatian: Zalmoxis je stanična disperzija za infuziju koja izgleda kao neprozirna, bjelkasta, smrznuta disperzija stanica.
English: Zalmoxis must be administered under the supervision of a physician experienced in haematopoietic stem cell transplantation for haematological malignacies.
Croatian: Zalmoxis se mora primjenjivati pod nadzorom liječnika s iskustvom u transplantaciji hematopoetskih matičnih stanica zbog hematoloških zloćudnih bolesti.
English: Treatment plan consisted of the administration of genetically modified donor's T lymphocytes (ranging from 1 x 106 to 1 x 107 cells/kg body weight).
Croatian: Plan liječenja sastojao se od primjene genetski modificiranih T-limfocita donora (u rasponu od 1 x 106
English: - You suffer from graft-versus-host disease which requires the use of medicines to suppress your immune system.
Croatian: - bolujete li od reakcije presatka protiv primatelja, koja zahtijeva primjenu lijekova za supresiju imunološkog sustava.
English: Febrile neutropenia Haemoglobin decreased Platelet count decreased
Croatian: Febrilna neutropenija Smanjena razina hemoglobina Smanjen broj trombocita
English: E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures: Description
Croatian: Uredbe (EZ) br. 726/2004, nositelj odobrenja dužan je unutar navedenog vremenskog roka provesti sljedeće mjere:
English: Zalmoxis must not be used in pregnant and breast-feeding women.
Croatian: Zalmoxis se ne smije primjenjivati u trudnica i žena koje doje.
English: Maximum time elapsed from thawing and infusion is 2 hours at room temperature (15 °C - 30 °C).
Croatian: Maksimalno vrijeme proteklo od odmrzavanja do infuzije je 2 sata pri sobnoj temperaturi (15 °C-30 °C).
English: The activated, transduced T lymphocytes that are causing the GvHD should convert the GCV to its toxic form and thereby undergo apoptosis.
Croatian: GvHD trebali bi pretvoriti GCV u njegov toksičan oblik te tako podlijeći apoptozi.
English: Precautions to be taken before handling or administering the medicinal product Before infusion it must be confirmed that the patient identity matches the essential unique information reported on the Zalmoxis bag label and on the related Certificate of Analysis (CoA).
Croatian: Prije infuzije mora se potvrditi da identitet bolesnika odgovara ključnim jedinstvenim podacima zabilježenim na naljepnici vrećice sa Zalmoxisom i na pripadajućem certifikatu o analizi.
English: In order to confirm the efficacy and safety of Zalmoxis as an adjunctive treatment in haploidentical haematopoietic stem-cell transplantation of adult patients with high-risk haematological malignancies, the MAH should submit the results of study TK008, a randomized phase III trial of haploidentical HCT with an add back strategy of HSV-Tk donor lymphocytes in patients with high risk acute leukaemia.
Croatian: Nositelj odobrenja dužan je, u naznačenom vremenskom roku, ispuniti mjere navedene u nastavku: Kako bi se potvrdila djelotvornost i sigurnost lijeka Zalmoxis kao pomoćnog liječenja kod haploidentične transplantacije hematopoetskih matičnih stanica u odraslih bolesnika s hematološkim zloćudnim bolestima visokog rizika, nositelj odobrenja treba podnijeti rezultate ispitivanja TK008, randomiziranog ispitivanja faze III haploidentične transplantacije hematopoetskih stanica sa strategijom dodavanja HSV-Tk donorskih limfocita u bolesnika s akutnom leukemijom visokog rizika.
English: The cells are of human origin and genetically modified with a replicationdefective γ-retroviral vector coding for the HSV-TK and ΔLNGFR genes so that these sequences are integrated in the genome of the host cells.
Croatian: Stanice su ljudskog podrijetla te su genetski modificirane γ-retrovirusnim vektorom bez svojstva replikacije koji kodira gene za HSV-TK i ΔLNGFR tako da se te sekvence ugrade u genom stanica domaćina.
English: Zalmoxis consists of white blood cells called T cells that are obtained from the donor.
Croatian: ŠTO JE ZALMOXIS I ZA ŠTO SE KORISTI Zalmoxis se sastoji od bijelih krvnih stanica zvanih T-stanice, koje se dobivaju od donora.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BAG
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
English: The safe use of Zalmoxis has not been demonstrated during pregnancy and breast-feeding.
Croatian: Trudnoća i dojenje Sigurna primjena Zalmoxisa za vrijeme trudnoće i dojenja nije dokazana.
English: Haploidentical means that the cells have been obtained from a donor whose tissues partially match the patient's tissue.
Croatian: Primjenjuje se nakon haploidentične transplantacije koštane srži (transplantacija hematopoetskih stanica). „Haploidentične“ znači da su stanice dobivene od donora čije se tkivo djelomično podudara s tkivom bolesnika.
English: You should tell your doctor before using Zalmoxis if:
Croatian: ŠTO MORATE ZNATI PRIJE NEGO VAM SE DA ZALMOXIS Nemojte primjenjivati Zalmoxis:
English: An adequate wash-out period shall be applied prior to infusion of this medicinal product.
Croatian: Prije infuzije ovog lijeka mora se primijeniti prikladno razdoblje ispiranja.
English: Zalmoxis is constituted of donor's T lymphocytes genetically modified to express the HSV-TK Mut2, as suicide gene.
Croatian: Zalmoxis se sastoji od donorskih T-limfocita koji su genetski modificirani kako bi eksprimirali HSV
English: The product should be administered immediately after thawing.
Croatian: Lijek se mora primijeniti odmah nakon odmrzavanja.
English: HOW TO STORE ZALMOXIS
Croatian: KAKO ČUVATI ZALMOXIS
English: The shipping is performed in liquid nitrogen vapour.
Croatian: Isporuka se vrši u pari tekućeg dušika.
English: In this case treatment with Zalmoxis should be delayed until 24 hours after the end of the antiviral therapy.
Croatian: U tom slučaju liječenje Zalmoxisom potrebno je odgoditi 24
English: - Decreased platelet count (reduction of the number of platelets in the blood) - Bronchitis (lung infection) - Pyrexia (fever)
Croatian: - Bronhitis (infekcija pluća) - Vrućica
English: Obligation to complete post-authorisation measures
Croatian: • Obveza provođenja mjera nakon davanja odobrenja
English: If at any time during or after treatment with Zalmoxis an acute GvHD of grade equal to or greater than 2 or a chronic GvHD develop, the patient has to be treated with ganciclovir at a dose of 10 mg/kg/day divided into 2 administrations intravenously, or valganciclovir 900 mg two times per day orally for 14 days.
Croatian: Ako u bilo koje vrijeme tijekom ili nakon liječenja lijekom Zalmoxis dođe do razvoja akutnog GvHD 2. stupnja ili višeg ili do razvoja kroničnog GvHD, bolesnika treba liječiti ganciklovirom u dozi od 10
English: Acute graft-versus-host disease (a complication that can occur after a stem-cell or bone marrow transplantation in which the newly transplanted donor cells attack the patient's body).
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) Akutna reakcija presatka protiv primatelja (komplikacija koja se može javiti nakon transplantacije matičnih stanica ili koštane srži pri kojoj netom transplantirane donorske stanice napadaju tijelo bolesnika).
English: Relevant information about the safety concerns of Graft versus Host Disease (GvHD)
Croatian: Relevantne informacije o sigurnosnim pitanjima o reakciji presatka protiv primatelja (GvHD, engl.
English: EXP: Shelf life after thawing: 2 hours at room temperature (15 °C - 30 °C)
Croatian: Rok valjanosti: Rok valjanosti nakon odmrzavanja: 2 sata na sobnoj temperaturi (15 °C - 30 °C)
English: Pyrexia
Croatian: Zalmoxisa.
English: • Conditional marketing authorisation
Croatian: • Uvjetno odobrenje za stavljanje gotovog lijeka u promet
English: Package leaflet: Information for the patient Zalmoxis 5-20 x 106 cells/mL dispersion for infusion
Croatian: Uputa o lijeku: Informacije za bolesnika Zalmoxis 5-20 x 106 stanica/ml disperzija za infuziju
English: Zalmoxis adverse reactions recorded in TK007 study
Croatian: Tabela 1. Nuspojave Zalmoxisa zabilježene u sklopu kliničkog ispitivanja TK007 Klasifikacija organskih sustava
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING PLASTIC BAG
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU
English: No interaction studies have been performed.
Croatian: Nisu utvrđene nikakve implikacije primjene
English: The most common adverse reaction reported by patients treated with Zalmoxis in clinical trial TK007 was acute GvHD.
Croatian: Najčešća nuspojava prijavljena od strane bolesnika liječenih Zalmoxisom u kliničkom ispitivanju
English: Overall, in the clinical study TK007, the 30 treated patients received their first infusion of Zalmoxis cells at a median time of 43 days from the date of HSCT.
Croatian: Sveukupno, u kliničkom ispitivanju TK007, 30 liječenih bolesnika primilo je prvu infuziju stanica
English: Only one 17-year-old male, affected by T lymphoblastic lymphoma, was treated in the TK007 trial with two infusions of Zalmoxis.
Croatian: T-limfoblastičnim limfomom, bio liječen u sklopu kliničkog ispitivanja TK007 s dvije infuzije
English: NAME OF THE MEDICINAL PRODUCT Zalmoxis 5-20 x 106 cells/mL dispersion for infusion
Croatian: NAZIV LIJEKA Zalmoxis 5-20 x 106 stanica/ml disperzija za infuziju
English: There are no data on the use of Zalmoxis during breast-feeding.
Croatian: Dojenje Nema podataka o primjeni Zalmoxisa tijekom dojenja.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Zalmoxis 5-20x106 cells/mL dispersion for infusion Intravenous use
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Zalmoxis 5-20 x 106 stanica/ml disperzija za infuziju Primjena u venu
English: SPECIAL STORAGE CONDITIONS Store in liquid nitrogen vapour.
Croatian: POSEBNE MJERE ČUVANJA Čuvati u pari tekućeg dušika.
English: During and after treatment with Zalmoxis the physician must be aware of acute and chronic sign and symptoms of GvHD at any time and ensure that either ganciclovir or valganciclovir is available at ward for early treatment of GvHD.
Croatian: Tijekom i nakon liječenja lijekom Zalmoxis, liječnici u svakom trenutku moraju paziti na akutne i kronične znakove i simptome
English: OTHER SPECIAL WARNING(S), IF NECESSARY Patient specific product not to be administered to other patients
Croatian: Lijek za određenog bolesnika, ne smije se primijeniti drugim bolesnicima
English: The recommended dose and schedule is 1 ± 0.2 x 107 cells/kg given as an intravenous infusion at a time interval of 21-49 days from transplantation, in the absence of spontaneous immune reconstitution and/or development of graft-versus-host disease (GvHD).
Croatian: između 21.-49. dana od transplantacije, u odsutnosti spontane imunološke rekonstitucije i/ili razvoja reakcije presatka protiv primatelja (GvHD, engl. graft-versus-host disease).
English: WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ZALMOXIS Do not use Zalmoxis: - If you are allergic to the active substance or any of the ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na djelatnu tvar ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: It is given after haploidentical bone marrow transplantation (haematopoietic cell transplantation).
Croatian: (G-CSF) koja je u tijeku nakon haploidentične transplantacije hematopoetskih matičnih stanica
English: Annex IV Conclusions on the granting of the conditional marketing authorisation and similarity presented by the European Medicines Agency
Croatian: ZAKLJUČCI EUROPSKE AGENCIJE ZA LIJEKOVE O IZDAVANJU UVJETNOG
English: Each bag contains a volume of 10-100 mL of frozen dispersion at a concentration of 5-20 x 106 cells/mL.
Croatian: Svaka vrećica sadrži volumen od 10-100 ml smrznute disperzije u koncentraciji 5-20 x 106 stanica/ml.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Sodium chloride
Croatian: 6.1 Popis pomoćnih tvari natrijev klorid ljudski serumski albumin dimetilsulfoksid
English: See leaflet for further information.
Croatian: Za daljnje informacije pogledajte uputu o lijeku.
English: Each bag of Zalmoxis contains a volume of 10-100 mL of frozen dispersion at the concentration of 5-20 x 106 cells/mL.
Croatian: Svaka vrećica Zalmoxisa sadrži volumen od 10-100 ml smrznute disperzije pri koncentraciji od 5-20 x