FrancophonIA/ELRC3.0 huggingface dataset:
English: The use of Zalmoxis is not recommended for children and adolescents under the age of 18.
Slovenian: Uporaba zdravila Zalmoxis se ne priporoča pri otrocih in mladostnikih, starih manj kot 18 let.
English: If GvHD occurs, GCV/VCV will be administered.
Slovenian: Če se pojavi GvHD, bolnik prejme GCV/VCV.
English: The decision to proceed with the next treament is determined by your physician/doctor and is related to your immune status.
Slovenian: Odločitev o nadaljevanju z zdravljenjem je povezana z vašim imunskim stanjem in jo sprejme vaš zdravnik.
English: Undesirable effects recorded in the clinical study TK007 are listed in Table 1 by system organ class and by frequency of occurrence.
Slovenian: Neželeni učinki, zabeleženi v klinični študiji TK007, so našteti v preglednici 1 po organskih sistemih in pogostnosti.
English: For the patients who achieved immune reconstitution, a nonrelapse mortality (NRM) of 17% was reported, with 35% of these patients being disease free at 5 years and 34% alive at 10 years.
Slovenian: so poročali o smrtnosti brez ponovitve pri 17 %, pri čemer je bilo 35 % od teh bolnikov 5 let preživelo brez bolezni in 34 % pa jih je bilo po 10 letih živih.
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.
Slovenian: Zdravilo Zalmoxis se daje za preprečevanje zapletov pri presadkih, ki se ne ujemajo popolnoma, znana kot "reakcija presadka proti darovalcu", kjer celice darovalca napadajo bolnikove lastne celice.
English: In case of IR achievement, documented by two consecutive CD3+ cell counts ≥ 100/µL, Zalmoxis treatment has to be stopped.
Slovenian: Če je dosežena IR, kar dokumentirata dve zaporedni števili celic CD3+ ≥ 100/μl, je treba zdravljenje z zdravilom Zalmoxis ustaviti.
English: Given the intended clinical use in the context of a haploidentical bone marrow transplantation, a need for treatment during pregnancy is not expected.
Slovenian: Zaradi nameravane klinične uporabe pri haploidentični presaditvi kostnega mozga se potreba po zdravljenju med nosečnostjo ne pričakuje.
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.
Slovenian: Močno se priporoča, da se ob koncu infundiranja zdravila Zalmoxis nalepka zdravila odstrani z vreče in vstavi v bolnikovo kartoteko.
English: Criteria for receiving Zalmoxis infusions included the lack of both immune reconstitution and GvHD.
Slovenian: Kriteriji za prejemanje infuzij zdravila Zalmoxis so vključevali izostanek imunske reaktivacije in GvHD.
English: - If you have any further questions, ask your doctor, or a physician experienced in the medical treatment of blood cancer.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom ali z zdravnikom z izkušnjami v zdravljenju krvnega raka z zdravili.
English: OTHER MolMed SpA
Slovenian: DRUGI PODATKI MolMed SpA
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.
Slovenian: Vsi znaki in simptomi akutne in obširne kronične GvHD 2. do 4. stopnje so po mediani trajanja zdravljenja z GCV ali VCV 15 dni povsem izzveneli.
English: Relevant information about the safety concern of Concomitant immunosuppressive therapy
Slovenian: Pomembne informacije glede varnosti sočasne uporabe imunosupresivov
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.
Slovenian: Odločitev o nadaljevanju z novim zdravljenjem je odvisna od stanja imunske reaktivacije, ki ga bolnik doseže, ko je število limfocitov T v obtoku 100 na µl ali več.
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).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Zalmoxis za eno ali več podskupin pediatrične populacije za naslednjo bolezen: dodatno zdravljenje pri presaditvi krvotvornih celic (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Any unused medicine or waste should be disposed of as biological hazard material containing genetically modified organisms and in accordance with local requirements.
Slovenian: Neuporabljeno zdravilo ali odpadni material zavrzite kot biološko nevarno snov, ki vsebuje gensko spremenjene organizme, v skladu z lokalnimi predpisi.
English: The cellular composition and the final cell number will vary according to the weight of the patient.
Slovenian: Celična zgradba in končno število celic se med bolniki razlikujejo glede na telesno maso.
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.
Slovenian: Le pri enem bolniku (3 %) se je razvila obširna kronična GvHD, ki se je pojavila 159 dni po haploidentični presaditvi krvotvornih matičnih celic in 129 dni po zadnjem infundiranju, po 107 dneh pa je povsem izzvenela.
English: CONTENTS OF THE PACK AND OTHER INFORMATION What Zalmoxis contains
Slovenian: VSEBINA PAKIRANJA IN DODATNE INFORMACIJE Kaj vsebuje zdravilo Zalmoxis
English: Conventional toxicology, carcinogenicity, mutagenicity and reproductive toxicology studies have not been performed.
Slovenian: Običajnih študij toksičnosti, kancerogenosti, mutagenosti ali študij vpliva na sposobnost razmnoževanja niso opravili.
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.
Slovenian: Zlasti pri imunski reaktivaciji predstavlja zdravilo Zalmoxis velik delež limfocitov v obtoku, medtem ko se kasneje delež zdravila Zalmoxis progresivno zmanjšuje, netransducirani limfociti pa se razširijo iz predhodnikov darovalcev.
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.
Slovenian: Bolniki s stanjem a) lahko dobijo zdravilo Zalmoxis 24 ur po prekinitvi protivirusne terapije; bolniki s stanjem b) in c) lahko dobijo zdravilo Zalmoxis po ustreznem obdobju izpiranja.
English: The entire volume of the bag has to be infused.
Slovenian: Infundirati je treba celotno količino vreče.
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:
Slovenian: Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bodo v vseh državah članicah, kjer je zdravilo Zalmoxis na trgu, vsi zdravstveni delavci, za katere se pričakuje, da bodo zdravilo Zalmoxis predpisovali, izdajali in dajali, prejeli dokument s smernicami, ki bo vseboval naslednje ključne elemente:
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.
Slovenian: V takih primerih bo obveščen vaš zdravnik, ki se lahko kljub temu odloči za zdravljenje ali za vas izbere alternativno zdravljenje.
English: Of 30 patients receiving Zalmoxis, 23 patients (77%) obtained immune reconstitution, with a median time of 31 days after the first infusion.
Slovenian: Od 30 bolnikov, ki so prejeli zdravilo Zalmoxis, je pri 23 bolnikih (77 %) prišlo do imunske reaktivacije z mediano časa 31 dni od prve infuzije.
English: No detrimental effects on such activities are predicted from the pharmacology of the medicinal product.
Slovenian: Na podlagi farmakologije zdravila škodljivi učinki na te aktivnosti ne predvidevajo.
English: • Shelf life after thawing is of 2 hours.
Slovenian: • Rok uporabnosti po odtajanju je 2 uri.
English: Women of childbearing potential have to use effective contraception during and up to 6 months after treatment with Zalmoxis.
Slovenian: Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem in še do 6 mesecev po zdravljenju z zdravilom Zalmoxis.
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).
Slovenian: Previdnostni ukrepi, potrebni pred ravnanjem z zdravilom ali dajanjem zdravila Pred infundiranjem je treba potrditi, da se identiteta bolnika ujema z bistveno edinstveno informacijo o bolniku na nalepki vreče z zdravilom Zalmoxis in na zadevnem analiznem certifikatu (CoA
English: It has been shown that Zalmoxis cells may circulate for years after the last administration.
Slovenian: Pokazalo se je, da so lahko celice v zdravilu Zalmoxis v obtoku še več let po zadnjem dajanju.
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.
Slovenian: Zdravljenje je treba prekiniti ob pojavu katerih koli dogodkov 3. do 4. stopnje, povezanih z dajanjem zdravila Zalmoxis, ali neželenimi učinki 2. stopnje, ki v naslednjih 30. dneh ne izzvenijo do 1. stopnje.
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.
Slovenian: Te celice bodo gensko spremenjene z uvedbo "samomorilskega" gena (HSV-TK Mut2) v genetski kod, ki se lahko kasneje aktivira v primeru reakcije presadka proti gostitelju.
English: In case of GvHD progression after 3 days of treatment with ganciclovir or valganciclovir alone, a standard immunosuppressive therapy has to be added.
Slovenian: V primeru napredovanja GvHD po 3 dneh zdravljenja samo z ganciklovirjem ali valganciklovirjem je treba dodati standardno imunosupresivno zdravljenje.
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.
Slovenian: Zdravilo Zalmoxis se daje intravensko (v žilo) v obliki kapalne infuzije, ki traja približno 20 do 60 minut, v časovnem intervalu 21 do 49 dni po presaditvi.
English: Zalmoxis adverse reactions recorded in TK007 study
Slovenian: Neželeni učinki zdravila Zalmoxis, ki so jih zabeležili v študiji TK007
English: Upon full cell dispersion thawing, the bag is dried, disinfected and ready to be infused at a rate prescribed by the physician.
Slovenian: Po popolnem odtajanju disperzije celic je vreča po osušitvi in razkužitvi pripravljena na infundiranje s hitrostjo, ki jo predpiše zdravnik.
English: - You suffer from infections requiring administration of ganciclovir (GCV) or valganciclovir (VCV) (antiviral) at the time of infusion.
Slovenian: - Imate okužbo, zaradi katere dobivate ganciklovir (GCV) ali valganciklovir (VCV) (protivirusna zdravila) v času infundiranja.
English: The activated, transduced T lymphocytes that are causing the GvHD should convert the GCV to its toxic form and thereby undergo apoptosis.
Slovenian: Aktivirani, transducirani limfociti T, ki povzročajo GvHD, GCV pretvorijo v njegovo toksično obliko, kar povzroči apoptozo.
English: Triphosphate GCV competitively, inhibits incorporation of deoxyguanosine triphosphate (dGTP) into elongating DNA, thus killing the proliferating cells.
Slovenian: Trifosfat GCV kompetitivno zavira vgrajevanje deoksigvanozin-trifosfata (dGTP) v podaljšujočo DNA, s čimer ubija množeče se celice.
English: For treating Zalmoxis-related GvHD through activation of the suicide gene, patients received GCV intravenously or VCV orally, for better patient convenience.
Slovenian: Za zdravljenje GvHD zaradi zdravila Zalmoxis z aktiviranjem samomorilskega gena so bolniki intravensko prejeli GCV ali peroralno VCV, kot je bilo za bolnika primerneje.
English: Zalmoxis should be infused intravenously over a period of 20-60 minutes.
Slovenian: Zdravilo Zalmoxis je treba intravensko infundirati 20 do 60 minut.
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.
Slovenian: Eno leto po dajanju zdravila Zalmoxis v na novo rekonstitutiranem repertoarju celic T prevladujejo netransducirane celice darovalskega izvora, ki kažejo poliklonsko strukturo, primerljivo s tisto pri zdravih posameznikih.
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.
Slovenian: • Ob koncu infundiranja vrečo 2- ali 3-krat izplaknite s fiziološko raztopino s sterilno tehniko, da zagotovite uporabo celotnega zdravila Zalmoxis.
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
Slovenian: Ker gre za pogojno dovoljenje za promet z zdravilom in ob upoštevanju člena 14(7) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet z zdravilom v določenem časovnem okviru izvesti naslednje ukrepe: Opis
English: BATCH NUMBER, DONATION AND PRODUCT CODES Batch:
Slovenian: ŠTEVILKA SERIJE, ENOTNE OZNAKE DAROVANJA IN IZDELKOV Številka serije:
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.
Slovenian: Če je treba infundiranje zdravila Zalmoxis prekiniti, se ne sme ponovno začeti, če je infuzijska vreča stala pri sobni temperaturi (15 °C do 30 °C) več kot 2 uri.
English: • Proceed with the infusion as quickly as possible, avoiding keeping the bag in the water bath after thawing.
Slovenian: • Infundirajte takoj, ko lahko, in vreče po odtajanju ne puščajte v vodni kopeli.
English: If you have any questions about symptoms or side effects, or if any symptoms concern you
Slovenian: Če imate kakršna koli vprašanja o simptomih ali neželenih učinkih ali vas zadevajo kateri koli simptomi → se takoj posvetujte z zdravnikom.
English: What Zalmoxis is and what it is used for What you need to know before you are given Zalmoxis How Zalmoxis is given to you Possible side effects
Slovenian: Kaj je zdravilo Zalmoxis in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo Zalmoxis Kako boste dobili zdravilo Zalmoxis
English: The most common adverse reaction reported by patients treated with Zalmoxis in clinical trial TK007 was acute GvHD.
Slovenian: Najpogostejši neželeni učinek, o katerem so poročali pri bolnikih, zdravljenih z zdravilom Zalmoxis v kliničnem preskušanju TK007, je bila akutna GvHD.
English: Additional infusions are administered at approximately one month intervals for a maximum of four times, until a circulating T lymphocyte count is equal to or more than 100 per µL.
Slovenian: Dodatne infuzije se dajejo v približno enomesečnih intervalih največ štirikrat, dokler ni število limfocitov T v obtoku 100 na µl ali več.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Patient specific product not to be administered to other patients
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Zdravila, specifičnega za bolnika, se ne sme dati drugim bolnikom.
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.
Slovenian: • Zunanjo in vmesno ovojnino je treba pregledati in se prepričati, da je na vrhu škatle in na vmesni vreči nalepka, specifična za bolnika.
English: • Zalmoxis is shipped directly to the medical facility where the infusion will be administered.
Slovenian: • Zdravilo Zalmoxis se pošlje neposredno zdravstveni ustanovi, kjer bo bolnik prejel infuzijo.
English: There may be cases in which the treating physician may still consider preferable to give the treatment or select an alternative treatment.
Slovenian: V nekaterih primerih bo lečeči zdravnik kljub temu presodil, da je bolje zdraviti ali izbrati alternativno zdravljenje.
English: Symptoms of overdose are not known.
Slovenian: 4.9 Preveliko odmerjanje Simptomi prevelikega odmerjanja niso znani.
English: The recommended infusion time is around 20-60 minutes
Slovenian: Priporočeni čas infundiranja je približno 20 do
English: • Zalmoxis has a shelf life of 18 months when stored in liquid nitrogen vapour.
Slovenian: • Rok uporabnosti zdravila Zalmoxis je 18 mesecev, če se shranjuje v hlapih tekočega dušika.
English: The primary mechanism of action of Zalmoxis relies on its ability to engraft and stimulate immunereconstitution.
Slovenian: Primarni mehanizem delovanja zdravila Zalmoxis temelji na njegovi sposobnosti, da se "prime" in stimulira imunsko reaktivacijo.
English: A longer interval might apply in case of renal failure.
Slovenian: V primeru ledvične odpovedi bo morda interval daljši.
English: Immunosuppressive therapy also affects immunocompetent cells as such infused with Zalmoxis.
Slovenian: Imunosupresivno zdravljenje lahko vpliva tudi na same imunokompetentne celice, infundirane z zdravilom Zalmoxis.
English: No implications on the use of Zalmoxis in patients of 65 and older have been established.
Slovenian: Vplivov uporabe zdravila Zalmoxis pri bolnikih, starih 65 let ali več, niso dokazali.
English: Zalmoxis has been manufactured specifically for you and cannot be administered to any other patient.
Slovenian: Zdravilo Zalmoxis je bilo izdelano poseben za vas, zato se ga ne sme dati nobenemu drugemu bolniku.
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).
Slovenian: Načrt zdravljenja je bil sestavljen iz dajanja gensko spremenjenih limfocitov T darovalca (v razponu od 1 x 106 do 1 x 107 celic/kg telesne mase).
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).
Slovenian: Zdravilo Zalmoxis je indicirano kot dodatno zdravljenje pri haploidentični presaditvi krvotvornih matičnih celic (HSCT-haematopoietic stem cell transplantation) odraslih bolnikov z velikim tveganjem za hematološke malignosti (glejte poglavje 5.1).
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.
Slovenian: Zdravila Zalmoxis se ne sme dajati bolnikom s sočasnim sistemskim imunosupresivnim zdravljenjem, saj lahko to zmanjša učinkovitost zdravljenja z zdravilom Zalmoxis pri zgodnji imunski rekonstituciji.
English: Even if donors are preliminary tested and found negative for transmissible infectious disease, precautions should be employed when handling Zalmoxis.
Slovenian: Kljub predhodnemu testiranju darovalcev in negativnim izvidom za prenosljive bolezni je pri ravnanju z zdravilom Zalmoxis potrebna previdnost.
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.
Slovenian: Tako bolniki kot bolnice, ki se zdravijo (bodo zdravili) z zdravilom Zalmoxis, in njihovi partnerji morajo med zdravljenjem z zdravilom Zalmoxis in še do 6 mesecev po njem uporabljati učinkovito kontracepcijo.
English: • When completely thawed, remove the Zalmoxis bag out from the double envelopment, dry it off and disinfect the outside.
Slovenian: • Vrečo s povsem odtajanim zdravilom Zalmoxis vzemite iz dvojnega ovoja, jo osušite in razkužite njeno zunanjost.
English: - If you get any side effects, talk to your doctor, or a physician experienced in the medical treatment of blood cancer.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali z zdravnikom z izkušnjami v zdravljenju krvnega raka z zdravili.
English: - If, before infusion, the value of CD3+ lymphocytes in your tests is equal to or more than 100 per μL.
Slovenian: - če je bila pred infundiranjem vrednost limfocitov v testih CD3+ 100 na μl ali več.
English: There are no data on the effect of Zalmoxis treatment on fertility.
Slovenian: Ni podatkov o vplivu zdravila Zalmoxis na plodnost.
English: It is given after haploidentical bone marrow transplantation (haematopoietic cell transplantation).
Slovenian: Daje se po haploidentični presaditvi kostnega mozga (presaditev krvotvornih celic).
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.
Slovenian: To omogoča selektivno ubijanje celic, ki se delijo, po dajanju predzdravila GCV, ki se s pomočjo HSV-TK encimatsko fosforilira do analoga aktivnega trifosfata.
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.
Slovenian: Za potrditev učinkovitosti in varnosti zdravila Zalmoxis kot dodatnega zdravljenja pri haploidentični presaditvi krvotvornih matičnih celic odraslih bolnikov z velikim tveganjem za hematološke malignosti mora imetnik dovoljenja za promet z zdravilom predložiti rezultate za študijo TK008, randomizirano preskušanje III. faze haploidentične presaditve krvotvornih matičnih celic z dodatno strategijo limfocitov HSV-Tk darovalcev pri bolnikih z velikim tveganjem za akutno levkemijo.
English: The dose corresponds to 1 ± 0.2 x 107 cells/kg.
Slovenian: 0,2 x 107 celic/kg.
English: If the medicinal product is not immediately prepared for infusion, transfer the bag in liquid nitrogen vapour.
Slovenian: Če se zdravilo ne pripravi takoj za infundiranje, vrečo prenašajte v hlapih tekočega dušika.
English: INSTRUCTIONS ON USE Not applicable
Slovenian: NAVODILA ZA UPORABO Navedba ni potrebna
English: Shelf life after thawing: 2 hours
Slovenian: Rok uporabnosti po odtajanju: 2 uri
English: The median interval time between the first and the subsequent infusions of Zalmoxis cells was 30 days.
Slovenian: Mediana časovnega intervala med prvo in naslednjo infuzijo celic zdravila Zalmoxis je bila
English: The identity of the patient must be matched with the essential unique donor information prior to infusion.
Slovenian: Ujemanje identitete bolnika je treba pred infundiranjem preveriti z bistveno edinstveno informacijo darovalca.
English: Zalmoxis is intended for use in adults with certain tumours of the blood known as high-risk haemotological malignancies.
Slovenian: Zdravilo Zalmoxis se uporablja pri odraslih z nekaterimi tumorji krvi, znanimi kot hematološke malignosti z velikim tveganjem.
English: - If you have previously experienced any adverse reaction following Zalmoxis administration and this has not been resolved within 30 days after its occurrence.
Slovenian: - Če ste predhodno imeli kakršne koli neželene učinke po dajanju zdravila Zalmoxis, ki niso izzveneli v 30 dneh od pojava.