FrancophonIA/ELRC3.0 huggingface dataset:
English: High-risk haematological malignancies treated with Zalmoxis included acute myeloid leukaemia (AML), secondary AML, acute lymphoblastic leukaemia, myelodysplastic syndrome and non-Hodgkin lymphoma.
Slovenian: Zelo tvegane hematološke malignosti, zdravljene z zdravilom Zalmoxis, vključjejo akutno mieloično levkemijo (AML), sekundarno AML, akutno limfoblastno levkemijo, mielodisplastični sindrom in ne-Hodgkinov limfom.
English: If you forget to use Zalmoxis
Slovenian: Če ste pozabili vzeti zdravilo Zalmoxis
English: o The room requirements for Zalmoxis administration o Storage, transport and thawing of Zalmoxis bag o Surveillance of Zalmoxis efficacy (Immune reconstitution - IR)
Slovenian: o Prostorske zahteve pri dajanju zdravila Zalmoxis o Shranjevanje, transport in tajanje vreče, ki vsebuje zdravilo Zalmoxis o Nadzorovanje učinkovitosti zdravila Zalmoxis (imunska rekonstitucija - IR)
English: • The cryobag and any unused product or waste material contains genetically modified organisms and should be disposed of in accordance with local requirements.
Slovenian: • Zamrzovalno vrečo in neuporabljeno zdravilo ali odpadni material, ki vsebuje gensko spremenjene organizme, zavrzite v skladu z lokalnimi predpisi.
English: • Check that the patient identity matches the essential and unique patient information reported on the Zalmoxis bag and on the Certificate of Analysis.
Slovenian: • Potrditi je treba, da se identiteta bolnika ujema z bistveno edinstveno informacijo o bolniku na vreči z zdravilom Zalmoxis in na analiznem certifikatu.
English: An adequate wash-out period shall be applied prior to infusion of this medicinal product.
Slovenian: Pred infundiranjem tega zdravila je potrebno ustrezno obdobje izpiranja.
English: Patients could be treated with Zalmoxis 24 hours after the antiviral or immunosuppressive therapy discontinuation.
Slovenian: Bolnike je možno z zdravilom Zalmoxis zdraviti 24 ur po prekinitvi antivirusnega ali imunosupresivnega zdravljenja.
English: • Once the patient is prepared for infusion, inspect the Zalmoxis bag for integrity.
Slovenian: • Ko je bolnik pripravljen na infundiranje, je treba pregledati, ali je vreča z zdravilom Zalmoxis nepoškodovana.
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.
Slovenian: 2 ali več ali kronična GvHD, je treba bolnika 14 dni zdraviti intravensko z ganciklovirjem v odmerku 10 mg/kg/dan razdeljeno na 2 odmerka ali peroralno z valganciklovirjem 900 mg dvakrat na dan.
English: Zalmoxis is obtained by donor blood cells.
Slovenian: Zdravilo Zalmoxis se pridobi iz krvnih celic darovalcev.
English: Immune reconstitution defined as circulating T lymphocytes ≥100 per μL at the day of planned infusion after haploidentical HSCT.
Slovenian: Imunska reaktivacija je opredeljena kot limfociti T v obtoku ≥ 100 na μl na dan načrtovanega infundiranja po haploidentični HSCT.
English: The other ingredients are sodium chloride, human serum albumin and dimethyl sulfoxide (see section
Slovenian: Druge sestavine zdravila so natrijev klorid, humani serumski albumin in dimetil sulfoksid (glejte poglavje 2).
English: Non Interventional PASS: In order to investigate the safety and effectiveness in real clinical practice as well as long-term safety and effectiveness in all patients treated with Zalmoxis, the MAH should conduct and submit the results of study TK011 using the EBMT registry including all patients treated with Zalmoxis.
Slovenian: Neintervencijska študija o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PASS): Za preučitev varnosti in učinkovitosti med dejansko klinično uporabo, kot tudi dolgotrajne varnosti in učinkovitosti pri vseh bolnikih, zdravljenih z zdravilom Zalmoxis, mora imetnik dovoljenja za promet z zdravilom s pomočjo registra EBMT izvesti študijo TK011, v katero bo vključil vse bolnike, zdravljene z zdravilom Zalmoxis,
English: 18 months when stored in liquid nitrogen vapour.
Slovenian: 18 mesecev pri shranjevanju v hlapih tekočega dušika.
English: However myeloablative conditioning regimens performed in the context of a haploidentical bone marrow transplantation is associated with sterility.
Slovenian: Vendar pa je režim mieloablativnega kondicioniranja, izveden pri haploidentični presaditvi kostnega mozga, povezan s sterilnostjo.
English: In this case treatment with Zalmoxis should be delayed until 24 hours after the end of the antiviral therapy.
Slovenian: V tem primeru je treba zdravljenje z zdravilom Zalmoxis prestaviti za 24 ur po koncu zdravljenja s protivirusnimi zdravili.
English: Post transplant lymphoproliferative disorder
Slovenian: potransplantacijska limfoproliferativna bolezen
English: In the event of pregnancy following Zalmoxis treatment adverse effect on pregnancy and the developing foetus are not expected as lymphocytes do not pass the placenta.
Slovenian: V primeru nosečnosti po zdravljenju z zdravilom Zalmoxis se neželeni učinki na nosečnost in razvoj zarodka ne pričakujejo, saj limfociti ne prehajajo v posteljico.
English: Zalmoxis should be administered after a 24-hour discontinuation period of ganciclovir or valganciclovir and immunosuppressive therapy.
Slovenian: Zdravilo Zalmoxis je treba dati po 24-urnem obdobju prekinitve dajanja ganciklovirja ali valganciklovirja in imunosupresivnega zdravljenja.
English: GvHD requiring systemic immunosupressive therapy.
Slovenian: GvHD, zaradi katere je potrebno sistemsko imunosupresivno zdravljenje.
English: In the clinical study TK007, 30 patients with high-risk haematological malignancies undergoing HSCT received Zalmoxis monthly up to a maximum of four infusions.
Slovenian: V klinični študiji TK007 je 30 bolnikov z velikim tveganjem za hematološke malignosti, pri katerih so izvedli HSCT, enkrat na mesec največ štirikrat prejelo infuzije zdravila Zalmoxis.
English: Zalmoxis is a patient specific product and should under no circumstances be administered to other patients.
Slovenian: Zdravilo Zalmoxis je zdravilo, specifično za bolnika, in ga v nobenih okoliščinah ni dovoljeno dajati drugim bolnikom.
English: Zalmoxis should not be administered if the circulating T lymphocytes are ≥100 per μL at the day of planned infusion after haploidentical HSCT.
Slovenian: Zdravila Zalmoxis se ne sme dati, če so T-limfociti v obtoku ≥ 100 na μl na dan načrtovanega infundiranja po haploidentični HSCT.
English: PHARMACEUTICAL FORM Dispersion for infusion.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA disperzija za infundiranje
English: Frequency and Adverse reactions Very common
Slovenian: Pogostnost in neželeni učinki
English: EXP: Shelf life after thawing: 2 hours at room temperature (15 °C - 30 °C)
Slovenian: EXP: Rok uporabnosti po odtajanju: 2 uri pri sobni temperaturi (15 °C do 30 °C)
English: The infusion solution should be used immediately after thawing.
Slovenian: Raztopino za infundiranje je treba infundirati takoj po odtajanju.
English: Zalmoxis 5-20 x 106 cells/mL cell dispersion for infusion contains 13.3 mmol (305.63 mg) of sodium per dose.
Slovenian: Zdravilo Zalmoxis 5 do 20 x 106 celic/ml celična disperzija za infundiranje vsebuje 13,3 mmol (305,63 mg) natrija na odmerek.
English: As this medicine is prescribed by a doctor, each dose is prepared for you only and each preparation consists of a single dose.
Slovenian: Če ste prejeli večji odmerek zdravila Zalmoxis, kot bi smeli Ker to zdravilo predpiše zdravnik, se vsak odmerek pripravi samo za vas; vsakič se pripravi le en odmerek.
English: Before handling or administering Zalmoxis
Slovenian: Pred ravnanjem z zdravilom ali dajanjem zdravila Zalmoxis
English: Do not infuse Zalmoxis if
Slovenian: Ne uporabljajte zdravila Zalmoxis, če
English: Zalmoxis is supplied as one individual treatment dose in a 50-500 mL ethylene-vinyl-acetate cryo bags.
Slovenian: Zdravilo Zalmoxis se dobavi kot odmerek za individualno zdravljenje v 50- do 500-ml zamrzovalnih vrečah iz etilen-vinil-acetata.
English: - If you suffer from graft-versus-host disease which requires the use of medicines to suppress your immune system.
Slovenian: - če trpite zaradi reakcije presadka proti gostitelju, zaradi katere morate uporabljati zdravila za zaviranje vašega imunskega sistema.
English: To monitor IR, the quantification analyses of CD3+ cells should be performed weekly during the first month after Zalmoxis administration.
Slovenian: Za spremljanje IR je treba prvi mesec po dajanju zdravila Zalmoxis tedensko izvajati analize kvantifikacije celic CD3+ .
English: If not used immediately, transfer the Zalmoxis bag from the shipping container to liquid nitrogen vapour.
Slovenian: Če se zdravilo Zalmoxis ne uporabi takoj, je treba vrečo iz transportnega vsebnika prestaviti v hlape tekočega dušika.
English: Dispersion for infusion Bag volume:___________mL Dose: 1x107 cells /kg Concentration: _____x10x cells/mL Total cell number: _____x10X
Slovenian: Odmerek: 1 x 107 celic/kg Koncentracija: _____x 10x celic/ml Skupno število celic: _____x 10X
English: Zalmoxis must be administered under the supervision of a physician experienced in HSCT for haematological malignancies.
Slovenian: Zdravilo Zalmoxis je treba dajati pod nadzorom zdravnika z izkušnjami v HSCT pri hematoloških malignostih.
English: • Upon completion of washing, the patient specific label on the bag should be removed and adhered to the patient specific file.
Slovenian: • Po končanem izplaknjenju je treba nalepko na infuzijski vrečki, specifično za bolnika, odlepiti in nalepiti v bolnikovo kartoteko.
English: You should tell your doctor before using Zalmoxis if:
Slovenian: Pred uporabo zdravila Zalmoxis zdravniku povejte, če:
English: The package is checked for the presence of any abnormality in the outer box and the label is checked for patient/donor correspondance.
Slovenian: Preveriti je treba, da je zunanja škatla nepoškodovana, in da se bolnik/darovalec na nalepki ujemata.
English: Zalmoxis is constituted of donor's T lymphocytes genetically modified to express the HSV-TK Mut2, as suicide gene.
Slovenian: Zdravilo Zalmoxis sestavljajo limfociti T darovalcev, ki so gensko spremenjeni tako, da kot samomorilski gen izražajo HSV-TK Mut2.
English: Zalmoxis must not be used in pregnant and breast-feeding women.
Slovenian: Zdravilo Zalmoxis se ne sme uporabljati pri nosečnicah in doječih ženskah.
English: • The unique patient information on the infusion bag does not match that of the scheduled patient.
Slovenian: • se edinstvena informacija o bolniku na infuzijski vrečki ne ujema z bolnikovimi podatki, na kakršenkoli način ni več zagotovljena celovitost zdravila.
English: Zalmoxis can only be prescribed and administered in a hospital by a doctor or a nurse who is trained in administering this medicine.
Slovenian: KAKO BOSTE DOBILI ZDRAVILO ZALMOXIS Zdravilo Zalmoxis lahko v bolnišnici predpiše in da samo zdravnik ali medicinska sestra, usposobljena za dajanje tega zdravila.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Total cell number: ____x10X
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT Skupno število celic: _____ x 10 X
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.
Slovenian: Celice so humanega izvora in so gensko spremenjene z replikacijsko okvarjenim γretrovirusnim vektorjem, ki kodira gene HSV-TK in ΔLNGFR, tako da se ta zaporedja vgradijo v genom gostiteljskih celic.
English: There are no data from the use of Zalmoxis in pregnant women.
Slovenian: Ni zadostnih podatkov o uporabi zdravila Zalmoxis pri nosečnicah.
English: The bag should appear as an opaque, off-white frozen cell dispersion.
Slovenian: Vreča mora vsebovati neprosojno, belkasto zamrznjeno celično disperzijo.
English: - Decreased platelet count (reduction of the number of platelets in the blood) - Bronchitis (lung infection) - Pyrexia (fever)
Slovenian: - zmanjšana raven hemoglobina (zmanjšanje števila rdečih krvnih celic) - zmanjšano število trombocitov (zmanjšanje števila krvnih ploščic) - bronhitis (okužba pljuč)
English: In-use storage times and conditions should not exceed 2 hours at room temperature (15 °C - 30 °C).
Slovenian: Čas in pogoji shranjevanja zdravila, ki se ne uporabi takoj, ne sme biti daljši kot 2 ure pri sobni temperaturi (15 °C do 30 °C).
English: Immune-reconstituted patients reached a CD3+ cell count ≥ 100/μL at a median of 77 days after
Slovenian: Bolniki z imunsko reaktivacijo so dosegli število celic CD3+ ≥ 100/μl v mediani časa 77 dni po haploidentični presaditvi krvotvornih matičnih celic.
English: When Zalmoxis cannot be given
Slovenian: Kdaj zdravila Zalmoxis ne smete prejeti
English: Zalmoxis is solely for use as patient specific medicinal product to be administered after HSCT and it is administered by intravenous infusion.
Slovenian: Način uporabe Zdravilo Zalmoxis se uporablja samo kot zdravilo, specifično za bolnika, po HSCT in se daje v obliki intravenske infuzije.
English: Women of childbearing potential / Contraception in males and females The risk on virus shedding vertical viral transmission is theoretically negligible however not excluded.
Slovenian: Tveganje za vertikalni prenos virusa zaradi izločanja virusa je teoretično zanemarljivo, ni pa izključeno.
English: As a precautionary measure, Zalmoxis must not be administered during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Zaradi previdnosti zdravila Zalmoxis ni dovoljeno uporabljati pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
English: SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
Slovenian: Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet Opis
English: Cases in which Zalmoxis cannot be supplied / infused In some cases, the patient may be unable to receive Zalmoxis because of manufacturing issues.
Slovenian: V nekaterih primerih bolniki zdravila Zalmoxis morda ne bodo mogli prejeti zaradi težav pri izdelavi.
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.
Slovenian: • Preveriti je treba, da je imetnik dovoljenja za promet z zdravilom poslal analizni certifikat, ki vsebuje identifikatorje za bolnika, datum izteka roka uporabnosti in odobritev za infundiranje.
English: Once the bag is infused, it is flushed 2 to 3 times with sodium chloride solution in order to completely administer Zalmoxis.
Slovenian: Po infundiranju se vreča 2- do 3-krat splakne z raztopino natrijevega klorida, da se zagotovi dajanje celotne količine zdravila Zalmoxis.
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.
Slovenian: Pomembne informacije glede varnosti pri reakciji presadka proti gostitelju (GvHD) Med zdravljenjem z zdravilom Zalmoxis in po njem se mora zdravnik ob vsakem trenutku zavedati akutnih in kroničnih znakov in simptomov GvHD in zagotoviti, da sta na oddelku za zgodnje zdravljenje GvHD na voljo ganciklovir ali valganciklovir.
English: In addition updates on recruitment should be submitted within the PSURs.
Slovenian: V PSUR je treba vključevati tudi posodobitve o vključevanju.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Zalmoxis Vsebina pakiranja in dodatne informacije
English: - You suffer from graft-versus-host disease which requires the use of medicines to suppress your immune system.
Slovenian: - Če trpite zaradi reakcije presadka proti gostitelju, zaradi katere morate uporabljati zdravila za zaviranje vašega imunskega sistema.
English: One bag contains donor T cells genetically modified to express HSV-TK and ΔLNGFR at the concentration of 5-20 x 106 cells/mL.
Slovenian: Ena vreča vsebuje donatorske celice T, ki so bile gensko spremenjene tako, da izražajo HSV-TK in ΔLNGFR v koncentraciji 5-20 x 106 celic/ml.
English: In the TK007 clinical study only one 66-year-old female was treated with one infusion of Zalmoxis.
Slovenian: Druge posebne populacije V klinični študiji TK007 je bila z eno infuzijo zdravila Zalmoxis zdravljena le ena 66-letna bolnica.
English: No adverse reactions were reported for this patient.
Slovenian: T. Za tega bolnika niso poročali o neželenih učinkih.
English: Zalmoxis contains sodium
Slovenian: Zdravilo Zalmoxis vsebuje natrij
English: The MAH shall complete, within the stated timeframe, the below measures:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okvirju izvesti naslednje ukrepe:
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.
Slovenian: Klinična učinkovitost in varnost Zdravilo Zalmoxis so ovrednotili v klinični študiji (TK007) faze I/II pri odraslih bolnikih s hematološkimi malignosti, pri katerih je bilo tveganje za ponovitev veliko, in ki so jim presadili matične celice darovalca z neujemajočim humanim levkocitnim antigenom (HLA) (haploidentičnega darovalca).
English: Zalmoxis has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Zalmoxis nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje ali upravljanja strojev.
English: Local biosafety guidelines applicable for such products should be followed for unused medicinal product or waste material.
Slovenian: Za neuporabljeno zdravilo ali odpadni material morate upoštevati lokalna navodila za biološko varnost, ki veljajo za ta zdravila.
English: The treating physician must ensure that patients do not receive ganciclovir or valganciclovir within 24 hours prior to the administration of Zalmoxis.
Slovenian: Pomembne informacije glede varnosti sočasne uporabe ganciklovirja in valganciklovirja Lečeči zdravnik mora zagotoviti, da bolnik ganciklovirja ali valganciklovirja ne prejme v 24 urah pred začetkom zdravljenja z zdravilom Zalmoxis.
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).
Slovenian: Zelo pogosti neželeni učinki (prizadenejo lahko več kot 1 od 10 bolnikov) Akutna reakcija presadka proti gostitelju (zaplet, ki se lahko pojavi po presaditvi matičnih celic ali kostnega mozga, ko na novo presajene darovalske celice napadajo bolnikovo telo).
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.
Slovenian: Zdravilo Zalmoxis je celična disperzija za infundiranje, ki ima videz neprosojne, belkaste zamrznjene celične disperzije.
English: Zalmoxis should not have any effects on your ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Zalmoxis ne bi smelo vplivati na vašo sposobnost vožnje ali upravljanja strojev.
English: Shelf life and special precautions for storage
Slovenian: Rok uporabnosti in posebni previdnostni ukrepi za shranjevanje zdravila
English: Zalmoxis consists of white blood cells called T cells that are obtained from the donor.
Slovenian: KAJ JE ZDRAVILO ZALMOXIS IN ZA KAJ GA UPORABLJAMO Zdravilo Zalmoxis sestavljajo bele krvne celice, imenovane celice T, ki so pridobljene od darovalca.
English: o Onset of GVHD requiring systemic immunosuppressive therapy o Ongoing systemic immunosuppressive therapy or administration of granulocyte colony stimulating factor (G-CSF) after haploidentical hematopoietic stem-cell transplantation
Slovenian: Bolniki zdravila Zalmoxis ne smejo prejeti v primeru: o nastopa GvHD, zaradi katere je potrebno sistemsko imunosupresivno zdravljenje o potekajočega sistemskega imunosupresivnega zdravljenja ali dajanja granulocitne kolonije spodbujajočega faktorja (G-CSF) po haploidentični presaditvi krvotvornih matičnih celic
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.
Slovenian: Skupaj je bil mediani čas, v katerem je 30 bolnikov, zdravljenih v klinični študiji TK007, prejelo prvo infuzijo celic zdravila Zalmoxis, 43 dni od datuma haploidentične presaditve krvotvornih matičnih celic.
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)
Slovenian: - kronična reakcija presadka proti gostitelju (zaplet, ki se lahko pojavi po presaditvi matičnih celic ali kostnega mozga, ko na novo presajene darovalske celice napadajo bolnikovo telo) - intestinalna hemoragija (krvavitev v prebavila) - odpoved jeter (nedelovanje jeter)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BAG
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
English: How to store Zalmoxis
Slovenian: SHRANJEVANJE ZDRAVILA ZALMOXIS
English: Practical information for handling and administration of Zalmoxis for the doctor or nurse can be found at the end of this leaflet.
Slovenian: Zalmoxis za zdravnike ali medicinske sestre so na koncu tega navodila.
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.
Slovenian: a) okužba, zaradi katere je treba dajati ganciklovir (GCV) ali valganciklovir (VCV) v času infundiranja; b) GvHD, zaradi katere je potrebno sistemsko imunosupresivno zdravljenje;
English: Healthcare professionals handling Zalmoxis should therefore take appropriate precautions (wearing gloves and glasses) to avoid potential transmission of infectious diseases.
Slovenian: (nošenje rokavic in očal) preprečiti možni prenos prenosljivih bolezni.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu, kjer so na voljo tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenjih.
English: One individual treatment dose in 50-500 mL ethylene-vinyl-acetate cryo bag, inside a plastic bag and then a metal box.
Slovenian: 6.5 Vrsta ovojnine in vsebina ter posebna oprema za uporabo, dajanje ali implantacijo En odmerek za individualno zdravljenje v 50- do 500-ml zamrzovalni vreči iz etilen-vinil-acetata v plastični vreči in nato v kovinski škatli.
English: - If you are taking medicines to suppress your immune system or you are taking G-CSF (that stimulates the bone marrow to produce blood cells) after receiving stem-cell transplantation .
Slovenian: - Če jemljete zdravila za zaviranje imunskega sistema ali če po presaditvi matičnih celic jemljete