natgillin/translations-raw huggingface dataset:
• Safety advice relevant to all patients o Description and management of neutropenia and thrombocytopenia including incidence rates from clinical trials o Description and management of thromboembolic risk including incidence rates from clinical trials and post-marketing experience o Use in patients with hepatic and/or renal impairment o Disposal of unwanted medicine o Local country specific arrangements for a prescription for Revlimid to be dispensed o Description of risk of hypothyroidism o Explanation of unknown risk of neuropathy with long term use
• varnostne nasvete, primerne za vse bolnike: o opis ter obravnavanje nevtropenije in trombocitopenije, vključno s stopnjo incidence v kliničnih študijah, o opis in obravnavanje trombemboličnega tveganja, vključno s stopnjo incidence v kliničnih študijah in izkušnje po začetku trženja, o uporabo pri bolnikih z jetrno in/ali ledvično okvaro, o odstranjevanje odvečnega zdravila, o lokalne, za državo značilne dogovore za predpisovanje in izdajanje zdravila Revlimid, o opis tveganja hipotiroidizma, o razlaga neznanega tveganja nevropatije pri dolgotrajni uporabi;
• National or other applicable specific arrangements for a prescription for Revlimid to be dispensed
• državne in druge ustrezne dogovore za predpisovanje in izdajanje zdravila Revlimid;
• The need to stop Revlimid immediately upon suspicion of pregnancy
• potrebo po takojšnji prekinitvi zdravljenja z zdravilom Revlimid pri sumu na nosečnost;
• Requirements in the event of pregnancy o Instructions to stop Revlimid immediately upon suspicion of pregnancy o Need to refer to physician specialised or experienced in dealing with teratology and its diagnosis for evaluation and advice o Local contact details for reporting of any suspected pregnancy o Pregnancy reporting form
• zahteve v primeru nosečnosti: o navodila za takojšnjo prekinitev zdravljenja z zdravilom Revlimid pri sumu na nosečnost, o potrebo po napotitvi k zdravniku specialistu za teratologijo ali z izkušnjami v teratologiji na diagnozo, oceno in posvet, o podrobnosti za stike za poročanje kakršnegakoli suma na nosečnost, o obrazec za poročanje nosečnosti;
Direct Healthcare Professional Communication
Neposredno obvestilo zdravstvenim delavcem
• Safety advice for women of childbearing potential o The need to avoid foetal exposure o Description of the PPP o Need for adequate contraception (even if woman has amenorrhoea) and definition of adequate contraception o Pregnancy test regime Advice on suitable tests Before commencing treatment During treatment based on method of contraception After finishing treatment o Need to stop Revlimid immediately upon suspicion of pregnancy o Need to tell treating doctor immediately upon suspicion of pregnancy
• varnostne nasvete za ženske v rodni dobi: o potrebo po izogibanju fetalni izpostavljenosti, o opis PPN-ja, o potrebo po ustrezni kontracepciji (tudi, če ima ženska amenorejo) in opredelitev ustrezne kontracepcije, o režim testov nosečnosti: nasvete za ustrezne teste, pred začetkom zdravljenja, med zdravljenjem, glede na kontracepcijsko metodo, po končanem zdravljenju, o potrebo po takojšnji prekinitvi zdravljenja z zdravilom Revlimid pri sumu na nosečnost, o potrebo po takojšnjem obveščanju lečečega zdravnika pri sumu na nosečnost;
• Pregnancy test regime o Before commencing treatment o During treatment every 4 weeks except in case of confirmed tubal sterilisation o After finishing treatment
o med zdravljenjem vsake 4 tedne razen v primeru sterilizacije jajcevodov,
• Obligations of the health care professional in relation to the prescribing of Revlimid o Need to provide comprehensive advice and counselling to patients o That patients should be capable of complying with the requirements for the safe use of Revlimid o Need to provide patients with appropriate patient educational brochure and patient card
o bolniki morajo biti sposobni upoštevati zahteve za varno uporabo zdravila Revlimid, o bolnikom je treba priskrbeti ustrezno izobraževalno brošuro in kartico bolnika;
• A core text as agreed by the CHMP.
• osrednjega besedila, ki ga odobri Odbor za uporabo zdravil v humani medicini (CHMP)
• That if his partner becomes pregnant he should inform his treating doctor immediately
• opozorilo, da mora takoj obvestiti lečečega zdravnika, če partnerica zanosi.
• Safety advice for men o The need to avoid foetal exposure o The need to use condoms if sexual partner is pregnant or a WCBP (even if man has had a vasectomy) During Revlimid treatment For one week following final dose.
• varnostne nasvete za moške: o potrebo po izogibanju fetalni izpostavljenosti, o potrebo po uporabi kondomov, če je spolna partnerica noseča ali ŽRD (tudi, če je moški imel vazektomijo): med zdravljenjem z zdravilom Revlimid, še en teden po zadnjem odmerku, o če partnerica zanosi, medtem ko bolnik jemlje zdravilo Revlimid ali kmalu po prenehanju jemanja zdravila Revlimid, mora takoj obvestiti lečečega zdravnika;
• Posology
• odmerjanje;
March 2021
Marec 2021
Some of these side effects may be serious and may lead to hospitalization.
Nekateri od teh neželenih učinkov so lahko resni in povzročijo hospitalizacijo.
Studies in animals have not been performed.
Študij na živalih niso izvedli.
The clinical study report should be submitted by March 2021.
Poročilo o klinični študiji je treba predložiti do marca 2021.
What to check before infusion
Kaj je treba preveriti pred infundiranjem
MARKETING AUTHORISATION NUMBER EU/1/16/1121/001
ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/16/1121/001
Progress updates should be submitted yearly with the annual renewal.
Posodobitve o napredovanju je treba predložiti letno z letnimi pregledi.
This may be because of manufacturing issues.
Razlog za so težave v izdelavi.
No specific paediatric group has been studied at present.
Pediatrična populacija Zaenkrat specifične pediatrične skupine niso preučevali.
This will ensure that the cells can be eliminated before they can cause damage to the patient's cells.
S tem se zagotovi, da se celice uničijo, preden poškodujejo bolnikove celice.
This medicinal product contains genetically-modified cells.
To zdravilo vsebuje gensko spremenjene celice.
• The Certificate of Analysis is marked as rejected.
• je analizni certifikat označen kot zavrnjen,
Currently, no data are available for these patients.
Trenutno podatkov za te bolnike ni na voljo.
There were no GvHD-related deaths or long-term complications.
Smrtnih primerov ali dolgotrajnih zapletov, povezanih z GvHD, ni bilo.
• You have not received the Certificate of Analysis.
• niste prejeli analiznega certifikata,
Additional infusions are given once a month, for up to 4 months.
Dodatne infuzije se dajejo enkrat na mesec do največ 4 mesece.
The safety and efficacy in children and adolescents (less than 18 years) have not been established.
Varnost in učinkovitost zdravila pri otrocih in mladostnikih (mlajših od 18 let), nista bili dokazani.
However, the risk of transmitting infectious viruses to healthcare professionals cannot be totally excluded.
Kljub temu tveganja za prenos kužnih virusov na zdravstvene delavce ni možno povsem izključiti.
Your doctor will closely supervise the treatment therapy.
Vaš zdravnik bo zdravljenje natančno spremljal.
It is unlikely that you will be given too much.
Ni verjetno, da bi prejeli preveč zdravila.
Chronic GvHD
kronična GvHD
Non clinical safety data obtained in two different immunedeficient animal models for GvHD did not indicate special hazards for humans, but allowed only a very limited safety assessment.
Predklinični podatki o varnosti, pridobljeni v dveh različnih živalskih modelih z imunsko pomanjkljivostjo za GvHD niso pokazali posebnega tveganja za človeka, vendar je bila mogoča le zelo omejena ocena varnosti.
• Put the bag into two plastic envelopes (double envelopment) to avoid direct contact with water.
• Vrečo vstavite v dve plastični ovojnini (dvojni ovoj), da preprečite neposredni stik z vodo.
Patient code:
Koda bolnika:
Please inform your doctor if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Severity of acute GvHD was grade 1 in one case (3%), grade 2 in seven (23%), grade 3 in one (3%) and grade 4 in one (3%).
Resnost akutne GvHD je bila v enem primeru 1. stopnje (3 %), v sedmih primerih 2. stopnje (23 %), v enem primeru 3. stopnje (3 %) in v enem primeru 4. stopnje (3 %).
The bag is put in a second bag (intermediate container) and this one is placed in an aluminium box (outer container).
Vreča je vstavljena v drugo vrečo (vmesni vsebnik), ta pa se položi v aluminijasto škatlo (zunanji vsebnik).
This medicine is prescribed by a doctor and given in a hospital under strict survelliance and predetermined schedule so that you cannot forget your dose.
To zdravilo predpiše zdravnik in se daje v bolnišnici pod natančnim spremljanjem in vnaprej določenem načrtu, zato na odmerek ne morete pozabiti.
However, you should pay attention to your overall status when considering performing tasks that require judgment, motor or cognitive skills.
Vendar pa bodite pozorni na svoje splošno stanje, če želite opravljati naloge, pri katerih morate biti presodni ali uporabljati motorične in kognitivne spretnosti.
Annex IV Conclusions on the granting of the conditional marketing authorisation and similarity presented by the European Medicines Agency
PRILOGA IV SKLEPNE UGOTOVITVE O PRIDOBITVI POGOJNEGA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER PODOBNOSTI, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
This strategy allows the direct targeting of those T lymphocytes that are initiating the GvHD response.
Ta strategija omogoča neposredno ciljanje limfocitov T, ki sprožijo odziv GvHD.
One patient with grade 1 acute GvHD did not receive any treatment.
En bolnik z akutno GvHD 1. stopnje ni prejel nobenega zdravljenja.
Both acute and chronic GvHD events developed only in patients who had achieved immune reconstitution.
Tako akutni kot kronični dogodki GvHD so se razvili le pri bolnikih, ki so dosegli imunsko reaktivacijo.
Women of childbearing potential have to provide a negative pregnancy test (serum or urine) within 14 days prior to start the treatment.
Ženske v rodni dobi morajo predložiti negativen test nosečnosti (serumski ali urinski), opravljen v roku 14 dni pred začetkom zdravljenja.
The amount of cells to be administered depends on your body weight.
Količina celic, ki jih boste prejeli, je odvisna od vaše telesne mase.
In addition to T cells, NK cells and residual levels of monocytes and of B cells may be present.
Poleg celic T so lahko prisotne tudi celice NK in rezidualne ravni monocitov in B-celic.
The nature and the intended use of the product are such that conventional studies on pharmacokinetics including absorption, distribution, metabolism and excretion are not applicable.
Narava in namen uporabe zdravila je taka, da običajne študije farmakokinetike, vključno z absorpcijo, porazdelitvijo, presnovo in izločanjem, niso smiselne.
There was no significant difference regarding leukaemia free survival and the chance for relapse.
Značilne razlike glede preživetja brez levkemije in možnosti za recidiv ni bilo.
Donors are tested for transmissible infectious agents in line with applicable local requirements.
Darovalci so testirani za povzročitelje nalezljivih bolezni v skladu z veljavnimi lokalnimi zahtevami.
Acute GvHD (33% of patients)
Bolezni imunskega sistema akutna GvHD (33 % bolnikov)
The whole package is secured in a liquid nitrogen container designed to maintain the appropriate transportation and storage temperature until the time of infusion.
Celotna pošiljka se vstavi v vsebnik s tekočim dušikom, kar zagotavlja ustrezen prevoz in temperaturo shranjevanja do trenutka infundiranja.
Pharmacotherapeutic group: Other antineoplastic agents, ATC code: not yet assigned
Farmakoterapevtska skupina: druga zdravila proti novotvorbam, oznaka ATC: še ni bila dodeljena
The hospital staff are responsible for the correct storage of the product both before and during its use, as well as for correct disposal.
Za pravilno shranjevanje zdravila pred in med uporabo ter za pravilno odstranjevanje je odgovorno osebje v bolnišnici.
Seven patients needed to add an immunosuppressive treatment consisting of steroids, mycophenolate and/or cyclosporine.
Sedem bolnikov je potrebovalo dodatno imunosupresivno zdravljenje, sestavljeno iz steroidov, mikofenolata in/ali ciklosporina.
Tel +39-02-212771 Fax +39-02-21277220 info@molmed.com
20132 Milano Italija tel. (+39) -02-212771 faks +39-02-21277220 e-pošta info@molmed.com
Remarks on the importance of reporting ADRs and encourage patients to be enrolled into study TK011 (linked with the EBMT registry)
Opombe o pomenu poročanja neželenih učinkov in spodbujanja bolnikov, da se vključijo v študijo TK011 (povezana z registrom EBMT)
Via Olgettina 58 20132 Milano Italy e-mail: info@molmed.com
Via Olgettina 58 20132 Milano Italija e-pošta: info@molmed.com
In this case, Zalmoxis may be administered after an adequate wash out period (the time necessary to remove a medicine from your body).
V tem primeru se lahko zdravilo Zalmoxis daje po ustreznem obdobju izpiranja (čas, potreben za odstranitev zdravila iz telesa).
Q4 2022
4. četrtletje 2022
The bag should be removed from the liquid nitrogen, put in a double bag container and thawed in a pre-warmed water bath at 37 °C.
Vrečo je treba vzeti iz tekočega dušika, položiti v vsebnik z dvojno vrečo in odtajati v vodni kopeli pri 37 °C.
Via Olgettina 58 20132 Milano Italy
Via Olgettina 58 20132 Milano Italija
Very common side effects (may affect more than 1 in 10 people)
Pogosti neželeni učinki (prizadenejo lahko največ 1 od 10 bolnikov)
Haploidentical means that the cells have been obtained from a donor whose tissues partially match the patient's tissue.
Haploidentično pomeni, da so bile celice pridobljene od darovalca s tkivom, ki se je z bolnikovim tkivom ujemajo le delno.
In vitro evaluation of oncological potential indicate that the risk of malignant transformation is low.
Ocene kancerogenega potenciala in vitro kažejo, da je tveganje za maligno transformacijo majhno.
Work surfaces and material which have potentially been in contact with Zalmoxis must be decontaminated with appropriate disinfectant.
Delovno površino in material, ki sta bila morda v stiku z zdravilom Zalmoxis, je treba dekontaminirati z ustreznim razkužilom.
In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted immediately.
V primeru prevelikega odmerjanja je treba pri bolnikih skrbno spremljati znake ali simptome neželenih učinkov in takoj uvesti ustrezno simptomatsko zdravljenje.
In some cases you may not be able to receive a scheduled infusion of Zalmoxis.
V nekaterih primerih morda ne boste mogli prejeti načrtovane infuzije zdravila Zalmoxis.
Results from a matched-pair analyses that included 36 Zalmoxis patients (22 from TK007 trial and 14 from the ongoing phase III TK008 trial) and 127 control patients, showed that the Zalmoxis treated patients that had survived the first 3 weeks post-transplant without relapse benefited in terms of 1 year overall survival (OS) (40% vs 51% (p=0.03)) and 1-year NRM (42% vs 23% (p=0.04)).
Rezultati analize usklajenih parov z vključenimi 36 bolniki, ki so dobivali zdravilo Zalmoxis (22 s preskušanja TK007 in 14 s preskušanja TK008 III. faze, ki še poteka) in 127 kontrolnih bolnikov je pokazala, da so imeli bolniki, zdravljeni z zdravilom Zalmoxis, ki so preživeli prve 3 tedne po presaditvi brez recidiva, koristi v smislu enoletnega celokupnega preživetja (OS-overall survival) (40 % v primerjavi z 51 % (p = 0,03)) in enoletnega NRM (42 % v primerjavi s 23 % (p = 0,04)).
A Detailed step-by step description of Zalmoxis administration procedure, also focusing on:
Podroben opis postopka dajanja zdravila Zalmoxis po korakih, ki se osredotoča tudi na:
• Zalmoxis must be used be immediately after removal from the shipping container.
• Zdravilo Zalmoxis je treba uporabiti takoj po odstranitvi iz transportnega vsebnika.
It is important that you read the entire content of this procedure prior to administering Zalmoxis.
Pomembno je, da preberete celotno vsebino tega postopka, preden bolniku aplicirate zdravilo Zalmoxis.
The clinical study report should be submitted by Q4 2022.
Poročilo o klinični študiji je treba predložiti do 4. četrtletja 2022.
All acute GvHD events fully resolved after a median duration of 12 days.
Vsi akutni dogodki GvHD so povsem izzveneli z mediano trajanja 12 dni.
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.
Primarni cilj študije TK007 je bilo oceniti incidenco in čas do imunske reaktivacije, kar je bilo opredeljeno kot število CD3+ ≥ 100/μl v obtoku v dveh zaporednih opažanjih, in incidenco GvHD ter odgovorom na GCV.
• Zalmoxis is prepared from human blood of a specific donor and it consists of genetically modified cells.
• Zdravilo Zalmoxis je pripravljeno iz humane krvi določenega darovalca in sestavljeno iz gensko spremenjenih celic.
Accordingly, healthcare professionals should take appropriate precautions (e.g. wearing gloves and glasses) when handling Zalmoxis.
Zato morajo zdravstveni delavci pri ravnanju z zdravilom Zalmoxis uporabljati ustrezne varnostne ukrepe (npr. nositi rokavice in očala).
• While holding the top of the envelope bag out of the water, put it in a 37±1°C water bath being careful not to allow water to penetrate the seal.
• Vrhnji konec ovojne vreče držite nad vodo, medtem ko jo vstavite v vodno kopel temperature 37 ± 1 °C; pazite, da voda ne prodre skozi tesnilo.
If the bag appears to have clear breaks or to be non-intact, do not use the product.
Če ima vreča vidne razpoke ali ni nepoškodovana, zdravila ne uporabljajte.
Each bag contains approximately 13.3 mmol (305.63 mg) of sodium per dose.
Ena vreča vsebuje približno 13,3 mmol (305,63 mg) natrija na odmerek.
The course of treatment is a maximum of four infusions at approximately one month intervals.
Potek zdravljenja sestavljajo največ štiri infuzije v približno enomesečnih intervalih.
• The expiry date has passed.
• se je rok uporabnosti iztekel,
• The entire volume of the bag must be infused.
• Infundirati je treba celotno količino vreče.
The use of Zalmoxis is not recommended for children and adolescents under the age of 18.
Uporaba zdravila Zalmoxis se ne priporoča pri otrocih in mladostnikih, starih manj kot 18 let.
If GvHD occurs, GCV/VCV will be administered.
Če se pojavi GvHD, bolnik prejme GCV/VCV.
The decision to proceed with the next treament is determined by your physician/doctor and is related to your immune status.
Odločitev o nadaljevanju z zdravljenjem je povezana z vašim imunskim stanjem in jo sprejme vaš zdravnik.
Undesirable effects recorded in the clinical study TK007 are listed in Table 1 by system organ class and by frequency of occurrence.
Neželeni učinki, zabeleženi v klinični študiji TK007, so našteti v preglednici 1 po organskih sistemih in pogostnosti.
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.
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.
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.
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.
In case of IR achievement, documented by two consecutive CD3+ cell counts ≥ 100/µL, Zalmoxis treatment has to be stopped.
Če je dosežena IR, kar dokumentirata dve zaporedni števili celic CD3+ ≥ 100/μl, je treba zdravljenje z zdravilom Zalmoxis ustaviti.
Given the intended clinical use in the context of a haploidentical bone marrow transplantation, a need for treatment during pregnancy is not expected.
Zaradi nameravane klinične uporabe pri haploidentični presaditvi kostnega mozga se potreba po zdravljenju med nosečnostjo ne pričakuje.
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.
Močno se priporoča, da se ob koncu infundiranja zdravila Zalmoxis nalepka zdravila odstrani z vreče in vstavi v bolnikovo kartoteko.
Criteria for receiving Zalmoxis infusions included the lack of both immune reconstitution and GvHD.
Kriteriji za prejemanje infuzij zdravila Zalmoxis so vključevali izostanek imunske reaktivacije in GvHD.
- If you have any further questions, ask your doctor, or a physician experienced in the medical treatment of blood cancer.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali z zdravnikom z izkušnjami v zdravljenju krvnega raka z zdravili.
OTHER MolMed SpA
DRUGI PODATKI MolMed SpA
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.
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.
Relevant information about the safety concern of Concomitant immunosuppressive therapy
Pomembne informacije glede varnosti sočasne uporabe imunosupresivov
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.
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.
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).
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).
Any unused medicine or waste should be disposed of as biological hazard material containing genetically modified organisms and in accordance with local requirements.
Neuporabljeno zdravilo ali odpadni material zavrzite kot biološko nevarno snov, ki vsebuje gensko spremenjene organizme, v skladu z lokalnimi predpisi.
The cellular composition and the final cell number will vary according to the weight of the patient.
Celična zgradba in končno število celic se med bolniki razlikujejo glede na telesno maso.
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.
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.
CONTENTS OF THE PACK AND OTHER INFORMATION What Zalmoxis contains
VSEBINA PAKIRANJA IN DODATNE INFORMACIJE Kaj vsebuje zdravilo Zalmoxis
Conventional toxicology, carcinogenicity, mutagenicity and reproductive toxicology studies have not been performed.
Običajnih študij toksičnosti, kancerogenosti, mutagenosti ali študij vpliva na sposobnost razmnoževanja niso opravili.