FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Zalmoxis in one or more subsets of the paediatric population in the following condition: adjunctive treatment in haematopoietic cell transplantation (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Zalmoxis u jednoj ili više podskupina pedijatrijske populacije u sljedećem stanju: pomoćno liječenje kod transplantacije hematopoetskih stanica (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: All signs and symptoms of grade 2 to 4 acute and extensive chronic GvHD fully resolved after a median treatment duration of GCV or VCV of 15 days.
Croatian: Svi znakovi i simptomi akutnog i opsežnog kroničnog GvHD-a 2. do 4. stupnja u potpunosti su se povukli nakon medijana trajanja liječenja GCV-om ili VCV-om od 15 dana.
English: In the TK007 clinical study only one 66-year-old female was treated with one infusion of Zalmoxis.
Croatian: U kliničkom ispitivanju TK007 samo je jedna 66-godišnja žena bila liječena jednom infuzijom Zalmoxisa.
English: Primary aims of the TK007 study were to evaluate incidence and time to immune reconstitution, defined by the number of circulating CD3+ ≥ 100/μL for two consecutive observations, and incidence of GvHD and response to GCV.
Croatian: Primarni ciljevi ispitivanja TK007 bili su procjena incidencije i vremena do imunološke rekonstitucije, definirane brojem cirkulirajućih CD3+ ≥100/μl za dva uzastopna promatranja, te incidencije GvHD-a i odgovora na GCV.
English: Any unused medicine or waste should be disposed of as biological hazard material containing genetically modified organisms and in accordance with local requirements.
Croatian: Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti kao biološki opasan materijal koji sadrži genetski modificirane organizme te u skladu s lokalnim propisima.
English: Relevant information about the safety concern of Concomitant immunosuppressive therapy
Croatian: Relevantne informacije o sigurnosnim pitanjima o istodobnoj primjeni terapije imunosupresivima
English: Healthcare professionals handling Zalmoxis should therefore take appropriate precautions (wearing gloves and glasses) to avoid potential transmission of infectious diseases.
Croatian: Zdravstveni bi radnici, stoga, pri rukovanju lijekom Zalmoxis trebali primijeniti prikladne mjere opreza (nositi rukavice i naočale) kako bi izbjegli mogući prijenos zaraznih bolesti.
English: Via Olgettina 58 20132 Milano Italy e-mail: info@molmed.com
Croatian: MolMed S.p.A. Via Olgettina 58 20132 Milano Italija e-pošta: info@molmed.com
English: If the medicinal product is not immediately prepared for infusion, transfer the bag in liquid nitrogen vapour.
Croatian: Ako se lijek ne priprema odmah za infuziju, premjestite vrećicu u paru tekućeg dušika.
English: The whole package is secured in a liquid nitrogen container designed to maintain the appropriate transportation and storage temperature until the time of infusion.
Croatian: Cijelo pakiranje zaštićeno je unutar spremnika tekućeg dušika koji je izrađen tako da održava odgovarajuću temperaturu tijekom transporta i čuvanja do same primjene infuzije.
English: - If you have previously experienced any adverse reaction following Zalmoxis administration and this has not been resolved within 30 days after its occurrence.
Croatian: - ako ste prethodno već iskusili neku nuspojavu nakon primjene Zalmoxisa te se ista nije povukla unutar 30 dana od njenog javljanja.
English: Zalmoxis is given intravenously (into a vein) as a drip infusion over approximately 20-60 minutes at a time interval of 21-49 days from transplantation.
Croatian: Zalmoxis se daje intravenski (u venu) u obliku infuzije (kapanjem) tijekom približno 20-60 minuta između 21.-49. dana od transplantacije.
English: Opaque, off-white frozen dispersion.
Croatian: Neprozirna, bjelkasta, smrznuta disperzija.
English: Globally, acute episodes of GvHD occurred in 10 patients (33%) with a median time to onset of 90 days after HSCT and 42 days after last infusion of Zalmoxis cells.
Croatian: Općenito, akutne epizode GvHD-a pojavile su se u 10 bolesnika (33%), s medijanom vremena do nastupa od 90 dana nakon HSCT-a i 42 dana nakon posljednje infuzije stanica Zalmoxisa.
English: The package is checked for the presence of any abnormality in the outer box and the label is checked for patient/donor correspondance.
Croatian: Pakiranje se pregledava radi eventualnih nepravilnosti na vanjskoj kutiji, a naljepnica radi provjere podudarnosti podataka između bolesnika i donora.
English: • Zalmoxis is prepared from human blood of a specific donor and it consists of genetically modified cells.
Croatian: • Zalmoxis se dobiva iz ljudske krvi određenog donora i sastoji se od genetski modificiranih stanica.
English: The MAH shall ensure that in each Member State where Zalmoxis is marketed, all HCPs who are expected to prescribe, dispense, and administer Zalmoxis are provided with a guidance document containing the following key elements:
Croatian: Nositelj odobrenja mora osigurati da u svakoj državi članici u kojoj je lijek Zalmoxis stavljen na tržište, svi zdravstveni radnici za koje se očekuje da će propisivati, izdavati i primjenjivati Zalmoxis dobiju dokument sa smjernicama u kojem su navedeni sljedeći ključni elementi:
English: Triphosphate GCV competitively, inhibits incorporation of deoxyguanosine triphosphate (dGTP) into elongating DNA, thus killing the proliferating cells.
Croatian: GCV trifosfat kompetitivno inhibira inkorporaciju deoksigvanozin trifosfata (dGTP) u produžujuću DNK, te tako ubija stanice u proliferaciji.
English: The decision to proceed with a new treatment depends on the immune reconstitution status of the patient achieved when a circulating T lymphocyte count is equal to or more than 100 per µL.
Croatian: Odluka o nastavku s novom terapijom ovisi o statusu imunološke rekonstitucije bolesnika koja je postignuta kada je broj cirkulirajućih T-limfocita jednak ili veći od 100 po µl.
English: Remarks on the importance of reporting ADRs and encourage patients to be enrolled into study TK011 (linked with the EBMT registry)
Croatian: Napomene o važnosti prijavljivanja nuspojava i poticanju bolesnika da se uključe u ispitivanje TK011 (povezano s registrom Europskog društva za transplantaciju koštane srži (EBMT))
English: The entire volume of the bag has to be infused.
Croatian: Mora se infundirati cijeli volumen vrećice.
English: 6.6 Special precautions for disposal and other handling Zalmoxis is a patient specific medicinal product.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Zalmoxis je lijek namijenjen za primjenu kod određenog bolesnika.
English: If you have any questions about symptoms or side effects, or if any symptoms concern you
Croatian: Ako imate pitanja o simptomima ili nuspojavama ili ako Vas bilo koji simptomi zabrinjavaju →odmah razgovarajte s liječnikom.
English: • The unique patient information on the infusion bag does not match that of the scheduled patient.
Croatian: • Jedinstveni podaci o bolesniku koji se nalaze na vrećici za infuziju ne odgovaraju podacima naručenog bolesnikua.
English: • The entire volume of the bag must be infused.
Croatian: • Mora se infundirati čitav volumen vrećice.
English: GvHD requiring systemic immunosupressive therapy.
Croatian: GvHD koja zahtijeva sustavnu imunosupresivnu terapiju.
English: In such cases your physician will be informed and may still consider preferable to give the treatment or may select an alternative treatment for you.
Croatian: Vaš će liječnik o tome biti informiran i može smatrati da je ipak bolje primijeniti liječenje ili odabrati zamjensko liječenje za Vas.
English: Intestinal haemorrhage
Croatian: Intestinalno krvarenje
English: In particular, at immune reconstitution Zalmoxis represents a high proportion of the circulating lymphocytes, while at later time points the proportion of Zalmoxis progressively decreases and untransduced lymphocytes expand from donor-derived precursors.
Croatian: Osobito, pri imunološkoj rekonstituciji Zalmoxis predstavlja visok udio cirkulirajućih limfocita, dok se kasnije udio Zalmoxisa progresivno smanjuje i netransducirani limfociti se šire od prekursora koji potječu od donora.
English: Relevant information about the safety concern of Concomitant administration of Ganciclovir and Valganciclovir
Croatian: Relevantne informacije o sigurnosnim pitanjima o istodobnoj primjeni ganciklovira i valganciklovira
English: If the infusion must be interrupted, it should not be resumed if the infusion bag has been held at room temperature (15 °C-30 °C) for more than 2 hours.
Croatian: Ako se infuziju mora prekinuti, ne smije se nastaviti ako je infuzijska vrećica stajala na sobnoj temperaturi (15 °C -30 °C) dulje od 2 sata.
English: The use of Zalmoxis is not recommended for children and adolescents under the age of 18.
Croatian: Primjena Zalmoxisa se ne preporučuje djeci i adolescentima mlađima od 18 godina.
English: Patients characterized by condition a) could be administered Zalmoxis 24 hours following the antiviral therapy discontinuation; patients characterized by conditions b) and c) could be administered Zalmoxis after an adequate wash out period.
Croatian: Bolesnici sa stanjem a) mogu primiti Zalmoxis 24 sata nakon prekida antivirusne terapije; bolesnici sa stanjem b) i c) mogu primiti Zalmoxis nakon odgovarajućeg razdoblja ispiranja.
English: It is important that you read the entire content of this procedure prior to administering Zalmoxis.
Croatian: Važno je da pročitate čitav sadržaj u vezi postupanja s lijekom prije same primjene Zalmoxisa.
English: BATCH NUMBER, DONATION AND PRODUCT CODES Batch:
Croatian: BROJ SERIJE, OZNAKE DONACIJE I PROIZVODA Serija:
English: The clinical status of the patient and the ADR profile of Zalmoxis should be born in mind when considering the patient's ability to perform tasks that require judgement, motor or cognitive skills.
Croatian: Potrebno je imati u vidu klinički status bolesnika te profil nuspojava Zalmoxisa prilikom razmatranja sposobnosti bolesnika da obavlja radnje koje zahtijevaju prosuđivanje te korištenje motoričkih ili kognitivnih vještina.
English: The patient did not experience any adverse reactions.
Croatian: Bolesnica nije imala nikakvih nuspojava.
English: These cells will be genetically modified by introducing a “suicide” gene (HSV-TK Mut2) in their genetic code which can be activated later on in case of graft-versus-host disease.
Croatian: Te stanice će biti genetski modificirane uvođenjem gena „samoubojice“ (HSV-TK Mut2) u njihov genetski kod koji se kasnije može aktivirati u slučaju reakcije presatka protiv primatelja.
English: It is recommended not to breast-feed during or after treatment with Zalmoxis therapy.
Croatian: Ne preporučuje se dojenje tijekom ili nakon liječenja Zalmoxisom.
English: Women of childbearing potential have to use effective contraception during and up to 6 months after treatment with Zalmoxis.
Croatian: Žene u reproduktivnoj dobi moraju koristiti učinkovitu kontracepciju tijekom i do 6 mjeseci nakon liječenja Zalmoxisom.
English: For treating Zalmoxis-related GvHD through activation of the suicide gene, patients received GCV intravenously or VCV orally, for better patient convenience.
Croatian: Za liječenje sa Zalmoxisom povezanog GvHD-a putem aktivacije samoubilačkog gena bolesnici su primili GCV intravenski ili VCV peroralno, radi bolje praktičnosti za bolesnika.
English: • Check that the patient identity matches the essential and unique patient information reported on the Zalmoxis bag and on the Certificate of Analysis.
Croatian: • Provjerite odgovara li identitet bolesnika ključnim i jedinstvenim podacima o bolesniku navedenima na vrećici Zalmoxisa i na certifikatu o analizi.
English: Human serum albumine, dimethyl sulphoxide, sodium chloride.
Croatian: Ljudski serumski albumin, dimetilsulfoksid, natrijev klorid.
English: • At the end of infusion, wash the bag 2 or 3 times with a physiological solution using a sterile technique, in order to completely administer Zalmoxis.
Croatian: • Na kraju infuzije isperite vrećicu 2 ili 3 puta fiziološkom otopinom primjenom sterilne tehnike kako bi se Zalmoxis potpuno primijenio.
English: In case of GvHD progression after 3 days of treatment with ganciclovir or valganciclovir alone, a standard immunosuppressive therapy has to be added.
Croatian: U slučaju progresije GvHD-a nakon tri dana liječenja samo ganciklovirom ili valganciklovirom, treba dodati standardnu terapiju imunosupresivima.
English: The treating physician must ensure that patients do not receive ganciclovir or valganciclovir within 24 hours prior to the administration of Zalmoxis.
Croatian: Nadležni liječnik mora osigurati da bolesnici ne prime ganciklovir ili valganciklovir unutar 24 sata prije primjene lijeka Zalmoxis.
English: Even if donors are preliminary tested and found negative for transmissible infectious disease, precautions should be employed when handling Zalmoxis (see section 4.4).
Croatian: Čak i ako su donori preliminarno ispitani i bili negativni na prijenosne zarazne bolesti, potrebno je primijeniti mjere opreza pri rukovanju lijekom Zalmoxis (vidjeti dio 4.4).
English: If leakage occurs during thawing, do not use the product.
Croatian: Ako dođe do istjecanja tijekom odmrzavanja, lijek nemojte koristiti.
English: Zalmoxis is obtained by donor blood cells.
Croatian: Zalmoxis se dobiva od donorskih krvnih stanica.
English: Criteria for receiving Zalmoxis infusions included the lack of both immune reconstitution and GvHD.
Croatian: Kriteriji za primanje infuzija Zalmoxisa bili su izostanak i imunološke rekonstitucije i GvHD-a.
English: Zalmoxis has no or negligible influence on the ability to drive and use machines.
Croatian: Zalmoxis ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: In absence of IR, an additional Zalmoxis dose has to be administered with an interval of 30 days up to a maximum number of four doses.
Croatian: U odsutnosti imunološke rekonstitucije, mora se primijeniti dodatna doza lijeka Zalmoxis s razmakom od 30 dana, do najviše četiri doze.
English: The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the conditional marketing authorisation as further explained in the European Public Assessment Report.
Croatian: Nakon razmatranja zahtjeva, mišljenje je CHMP (Povjerenstvo za humane lijekove) da je omjer rizika i koristi povoljan te se može preporučiti izdavanje uvjetnog odobrenja za stavljanje gotovog lijeka u promet, a što je dodatno objašnjeno u Europskom javnom izvješću o ocjeni lijeka.
English: Only one patient (3%) developed an extensive chronic GvHD that occurred 159 days and 129 days from HSCT and last infusion, respectively, and fully resolved after 107 days.
Croatian: Samo u jednog bolesnika (3%) razvio se opsežni kronični GvHD, koji se pojavio 159 dana nakon HSCT-a i 129 dana nakon posljednje infuzije,
English: Patient code:
Croatian: Oznaka bolesnika:
English: This allows the selective killing of dividing cells upon administration of the pro-drug GCV, which is enzymatically phosphorylated to an active triphosphate analogue by HSV-TK.
Croatian: To omogućava selektivno ubijanje stanica u diobi nakon primjene prolijeka GCV-a, koji se enzimski fosforilira u aktivni trifosfatni analog putem HSV-TK-a.
English: • Zalmoxis has a shelf life of 18 months when stored in liquid nitrogen vapour.
Croatian: • Zalmoxis ima rok valjanosti od 18 mjeseci kada se čuva u pari tekućeg dušika.
English: In case of IR achievement, documented by two consecutive CD3+ cell counts ≥ 100/µL, Zalmoxis treatment has to be stopped.
Croatian: U slučaju postizanja imunološke rekonstitucije, dokumentirane dvama uzastopnim mjerenjima broja CD3+ stanica ≥ 100/μl, liječenje lijekom Zalmoxis mora se prekinuti.
English: Treatment should be discontinued in case of occurrence of any 3-4 grade event related to Zalmoxis administration or grade 2 adverse event not resolving in a grade 1 or less in the next 30 days.
Croatian: Liječenje treba prekinuti u slučaju pojave bilo kojeg događaja 3. - 4. stupnja povezanog s primjenom lijeka Zalmoxis ili nuspojave 2. stupnja koja ne prolazi do 1. stupnja ili manje u sljedećih 30 dana.
English: Immunosuppressive therapy also affects immunocompetent cells as such infused with Zalmoxis.
Croatian: Terapija imunosupresivima također utječe na imunokompetentne stanice koje su infuzijom primljene s lijekom Zalmoxis.
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.
Croatian: U sklopu kliničkog ispitivanja TK007, 30 bolesnika s hematološkim zloćudnim bolestima visokog rizika podvrgnutih HSCT-u dobivalo je Zalmoxis jednom mjesečno do najviše četiri infuzije.
English: When Zalmoxis cannot be given
Croatian: Kada se Zalmoxis ne može primijeniti
English: The other ingredients are sodium chloride, human serum albumin and dimethyl sulfoxide (see section
Croatian: Drugi sastojci su natrijev klorid, ljudski serumski albumin i dimetilsulfoksid (vidjeti dio 2).
English: There are no data on the effect of Zalmoxis treatment on fertility.
Croatian: Nema podataka o utjecaju liječenja Zalmoxisom na plodnost.
English: It is strongly recommended that, at the end of Zalmoxis infusion, the product label is removed from the bag and placed in the patient record sheet.
Croatian: Izričito se preporučuje da se nakon završetka infuzije Zalmoxisa skine naljepnica lijeka s vrećice te se zalijepi u karton bolesnika.
English: Both male and female patients (to be) treated with Zalmoxis and their partners need to use effective contraception during and up to 6 months after treatment with Zalmoxis.
Croatian: Bolesnici kao i bolesnice (koji će biti) liječeni Zalmoxisom te njihovi partneri moraju koristiti učinkovitu kontracepciju tijekom i sve do 6 mjeseci nakon liječenja Zalmoxisom.
English: The clinical study report should be submitted by Q4 2022.
Croatian: Izvješće o kliničkom ispitivanju potrebno je podnijeti do četvrtog tromjesečja 2022.
English: One year post-Zalmoxis administration the newly reconstituted T cell repertoire is dominated by untransduced cells of donor origin which displayed a polyclonal pattern comparable to healthy individuals.
Croatian: Godinu dana nakon primjene Zalmoxisa, nanovo rekonstituiranim repertoarom T-stanica dominiraju netransducirane stanice koje potječu od donora, a pokazuju poliklonalni uzorak usporediv sa zdravim osobama.
English: Zalmoxis is intended for use in adults with certain tumours of the blood known as high-risk haemotological malignancies.
Croatian: Zalmoxis je namijenjen odraslima s određenim vrstama raka krvi poznatima kao hematološke zloćudne bolesti visokog rizika.
English: However myeloablative conditioning regimens performed in the context of a haploidentical bone marrow transplantation is associated with sterility.
Croatian: Ipak, mijeloablativni režimi kondicioniranja izvedeni u kontekstu haploidentične transplantacije koštane srži dovode se u vezu sa sterilnošću.
English: The bag should appear as an opaque, off-white frozen cell dispersion.
Croatian: Vrećica mora izgledati kao neprozirna, bjelkasta, smrznuta disperzija stanica.
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.
Croatian: Neintervencijsko ispitivanje sigurnosti primjene lijeka nakon davanja odobrenja za stavljanje lijeka u promet (PASS): Kako bi se ispitala sigurnost i učinkovitost u stvarnoj kliničkoj praksi kao i dugoročna sigurnosti i učinkovitost u svih bolesnika liječenih lijekom Zalmoxis, nositelj odobrenja treba provesti ispitivanje TK011 i podnijeti rezultate tog ispitivanja pomoću registra EBMT koji uključuje sve bolesnike liječene lijekom Zalmoxis.
English: Frequency and Adverse reactions Very common
Croatian: Učestalosti i nuspojave Vrlo često
English: Prior to launch of Zalmoxis in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials for the Health Care Professionals (HCPs), with the National Competent Authority.
Croatian: Prije stavljanja lijeka Zalmoxis u promet u svakoj državi članici nositelj odobrenja mora s nacionalnim nadležnim tijelom usuglasiti sadržaj i format edukacijskih materijala namijenjenih zdravstvenim radnicima.
English: As a precautionary measure, Zalmoxis must not be administered during pregnancy and in women of childbearing potential not using contraception.
Croatian: Kao mjera opreza, Zalmoxis se ne smije primjenjivati tijekom trudnoće te u žena reprodukcijske dobi koje ne koriste kontracepciju.
English: A longer interval might apply in case of renal failure.
Croatian: Dulji interval može se primijeniti u slučaju zatajenja bubrega.
English: • Shelf life after thawing is of 2 hours.
Croatian: • Rok valjanosti nakon odmrzavanja je 2 sata.
English: Zalmoxis is indicated as adjunctive treatment in haploidentical haematopoietic stem cell transplantation (HSCT) of adult patients with high-risk haematological malignancies (see section 5.1).
Croatian: Zalmoxis je indiciran kao pomoćno liječenje kod haploidentične transplantacije hematopoetskih matičnih stanica (HSCT, engl. haematopoietic stem cell transplantation) u odraslih bolesnika s hematološkim zloćudnim bolestima visokog rizika (vidjeti dio 5.1).
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.
Croatian: slučaju trudnoće nakon liječenja Zalmoxisom, ne očekuju se štetni učinci na trudnoću i razvoj fetusa budući da limfociti ne prelaze posteljicu.
English: Zalmoxis should not have any effects on your ability to drive and use machines.
Croatian: Zalmoxis ne bi trebao imati nikakav utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
English: Even if donors are preliminary tested and found negative for transmissible infectious disease, precautions should be employed when handling Zalmoxis.
Croatian: Čak i ako su donori preliminarno ispitani i bili negativni na prijenosne zarazne bolesti, potrebno je primijeniti mjere opreza pri rukovanju lijekom Zalmoxis.
English: High-risk haematological malignancies treated with Zalmoxis included acute myeloid leukaemia (AML), secondary AML, acute lymphoblastic leukaemia, myelodysplastic syndrome and non-Hodgkin lymphoma.
Croatian: Hematološke zloćudne bolesti visokog rizika liječene lijekom Zalmoxis uključivale su akutnu mijeloičnu leukemiju (AML), sekundarnu AML, akutnu limfoblastičnu leukemiju, mijelodisplastični sindrom i ne
English: - You suffer from infections requiring administration of ganciclovir (GCV) or valganciclovir (VCV) (antiviral) at the time of infusion.
Croatian: - bolujete li od infekcija koje zahtijevaju primjenu ganciklovira (GCV) ili valganciklovira (VCV)
English: In addition to T cells, NK cells and residual levels of monocytes and of B cells may be present.
Croatian: Uz T-stanice mogu biti prisutne i NK stanice te ostatne količine monocita i B-stanica.
English: • Once the patient is prepared for infusion, inspect the Zalmoxis bag for integrity.
Croatian: • Jednom kada je bolesnik spreman za infuziju provjerite je li vrećica Zalmoxisa čitava i neoštećena.
English: If not used immediately, transfer the Zalmoxis bag from the shipping container to liquid nitrogen vapour.
Croatian: Ukoliko je nećete odmah koristiti, vrećicu Zalmoxisa premjestite iz spremnika za dostavu u paru tekućeg dušika.
English: In some cases you may not be able to receive a scheduled infusion of Zalmoxis.
Croatian: U nekim slučajevima možda nećete moći primiti infuziju Zalmoxisa prema dogovorenom rasporedu.