FrancophonIA/ELRC3.0 huggingface dataset:
English: If you get any side effects, talk to your doctor or nurse.
Slovenian: Če opazite kateri koli izmed neželenih učinkov, se posvetujte z zdravnikom ali medicinsko sestro.
English: During the concomitant use of thiotepa and inhibitors of CYP2B6 or CYP3A4, patients should be carefully monitored clinically (see section 4.5).
Slovenian: Med sočasno uporabo tiotepe in zaviralcev CYP2B6 ali CYP3A4 je treba bolnike pozorno klinično spremljati (glejte poglavje 4.5).
English: Thiotepa is a highly lipophilic compound.
Slovenian: Tiotepa je močno lipofilna spojina.
English: You must tell your doctor if you are pregnant or you think you may be pregnant before you receive TEPADINA.
Slovenian: Obvestite svojega zdravnika, če ste noseči ali menite, da ste, preden prejmete zdravilo TEPADINA.
English: Serious toxicities involving the haematologic, hepatic and respiratory systems were considered as expected consequences of the conditioning regimen and transplant process.
Slovenian: Hude toksičnosti v povezavi s hematološkim, jetrnim in dihalnim sistemom so bile pričakovane posledice režima pripravljalnega zdravljenja in procesa presaditve.
English: There is no known antidote for thiotepa.
Slovenian: Za tiotepo ni znanega antidota.
English: Inject the content of the syringe into the vial through the rubber stopper.
Slovenian: Injicirajte vsebino brizge v vialo skozi gumijasti zamašek.
English: Prophylactic or empiric use of anti-infectives (bacterial, fungal, viral) should be considered for the prevention and management of infections during the neutropenic period.
Slovenian: Preventivna ali empirična uporaba zdravil proti okužbam (bakterijskim, glivičnim, virusnim) je priporočljiva za preprečevanje in obvladovanje okužb v obdobju nevtropenije.
English: Dose modification is not recommended for transient alterations of hepatic parameters (see section 4.4).
Slovenian: Prilagoditev odmerka ni potrebna pri prehodnih spremembah jetrnih parametrov (glejte poglavje 4.4).
English: - if you are allergic to thiotepa, - if you are pregnant or think you may be pregnant, - if you are breast-feeding, - if you are receiving yellow fever vaccination, live virus and bacterial vaccines.
Slovenian: - če ste noseči ali menite, da ste, - če dojite, - če prejemate cepivo za rumeno mrzlico, cepiva z živimi virusi in bakterijska cepiva.
English: Remove the syringe and the needle and mix manually by repeated inversions.
Slovenian: Odstranite brizgo in iglo ter ročno premešajte tako, da vialo večkrat obrnete.
English: The metabolites are active alkylating agents but the role they play in the antitumor activity of thiotepa remains to be elucidated.
Slovenian: Metaboliti so aktivne alkilirajoče snovi, a vlogo, ki jo imajo pri protitumorski aktivnosti tiotepe, je treba še pojasniti.
English: Women of childbearing potential have to use effective contraception during treatment and a pregnancy test should be performed before treatment is started.
Slovenian: Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem, pred vsakim zdravljenjem pa je treba opraviti test nosečnosti.
English: These metabolites are not found in urine, and, if formed, are probably excreted in bile or as intermediate metabolites rapidly converted into thiotepa-mercapturate.
Slovenian: Teh metabolitov ne najdemo v urinu, in se, če se oblikujejo, verjetno izločijo v žolč ali se kot vmesni metaboliti hitro pretvorijo v tiotepo-merkapturat.
English: Concomitant use with yellow fever vaccine and with live virus and bacterial vaccines (see section 4.5).
Slovenian: Sočasna uporaba s cepivom za rumeno mrzlico in z živimi virusnimi in bakterijskimi cepivi (glejte poglavje 4.5).
English: After intravenous administration, CSF medicinal product exposure is nearly equivalent to that achieved in plasma; the mean ratio of AUC in CSF to plasma for thiotepa is 0.93.
Slovenian: Po intravenskem dajanju je izpostavljenost zdravilu s CSF (colony stimulating factor) skoraj enaka tisti, doseženi v plazmi; povprečno razmerje med AUC v CSF in plazmi za tiotepo je 0,93.
English: Both women and men using TEPADINA must use effective contraceptive methods during treatment.
Slovenian: Ženske in moški, ki uporabljajo zdravilo TEPADINA, morajo med zdravljenjem uporabljati učinkovite metode kontracepcije.
English: The mean urinary recovery of thiotepa and its metabolites is 0.5% for the unchanged medicinal product and monochlorotepa, and 11% for TEPA and thiotepa-mercapturate.
Slovenian: Povprečni urinarni izplen tiotepe in njenih presnovkov je 0,5 % za nespremenjeno zdravilo in monoklorotepo ter 11 % za TEPA in tiotepo-merkapturat.
English: Urinary excretion of thiotepa and TEPA is nearly complete after 6 and 8 hours respectively.
Slovenian: Izločanje tiotepe in TEPA v urinu je skoraj popolno po 6 oziroma 8 urah.
English: RIEMSER Pharma GmbH Bahnhofstraße 44b 17489 Greifswald Germany
Slovenian: RIEMSER Pharma GmbH Bahnhofstraße 44b 17489 Greifswald
English: These data support the efficacy of conditioning regimens based on thiotepa in all haematological diseases.
Slovenian: Ti podatki potrjujejo učinkovitost režimov pripravljalnega zdravljenja na osnovi tiotepe pri vseh hematoloških boleznih.
English: After intravenous administration, plasma concentrations of the active substance fit a two compartment model with a rapid distribution phase.
Slovenian: Po intravenskem dajanju koncentracije zdravilne učinkovine v plazmi ustrezajo modelu z dvema predelkoma s hitro fazo porazdelitve.
English: There are no data on the use of thiotepa during pregnancy.
Slovenian: Ni podatkov o uporabi tiotepe med nosečnostjo.
English: Reconstituted solutions may occasionally show opalescence; such solutions can still be administered.
Slovenian: Rekonstituirane raztopine so lahko občasno opalescentne, vendar jih lahko kljub temu uporabite.
English: The total clearance of thiotepa ranged from 11.4 to 23.2 l/h/m2.
Slovenian: Celotni očistek tiotepe je bil med 11,4 do 23,2 l/h/m2.
English: The radiomimetic action of thiotepa is believed to occur through the release of ethylene imine radicals that, as in the case of irradiation therapy, disrupt the bonds of DNA, e.g. by alkylation of guanine at the N-7, breaking the linkage between the purine base and the sugar and liberating alkylated guanine.
Slovenian: Do radiomimetičnega delovanja tiotepe naj bi prišlo zaradi sproščanja radikalov etilen imina, ki kot pri zdravljenju z obsevanjem prekine vezi DNK, npr. z alkilacijo gvanina na mestu N-7, kar prekine vez med purinsko bazo in sladkorjem ter sprosti alkiliran gvanin.
English: GENETIC DISEASES
Slovenian: GENETSKE BOLEZNI
English: Previous brain irradiation or craniospinal irradiation may contribute to severe toxic reactions (e.g. encephalopathy).
Slovenian: Predhodno obsevanje možganov ali kraniospinalnega predela lahko pripomore k hudim toksičnim učinkom (npr. encefalopatiji).
English: The high intra-individual variability of the coagulation state during malignancy, and the potential interaction between oral anticoagulants and anticancer chemotherapy require, if it is decided to treat the patient with oral anticoagulants, to increase the frequency of the INR (International Normalised Ratio) monitoring.
Slovenian: Visoka intraindividualna variabilnost stanja koagulacije med malignostjo in potencialna interakcija med peroralnimi antikoagulanti in kemoterapijo proti raku zahtevata povečanje pogostnosti spremljanja internacionalnega normaliziranega razmerja (INR), če se bolnik zdravi z peroralnimi antikoagulanti.
English: The total excreted amount of thiotepa and its identified metabolites accounts for 54-100% of the total alkylating activity, indicating the presence of other alkylating metabolites.
Slovenian: Skupna izločena količina tiotepe in njenih ugotovljenih metabolitov predstavljajo 54-100 % vse alkilirajoče aktivnosti, kar kaže na prisotnost še drugih alkilirajočih metabolitov.
English: TEPADINA can be used in adults and children and adolescents.
Slovenian: Zdravilo TEPADINA se uporablja pri odraslih, otrocih in mladostnikih.
English: Your doctor will monitor your blood counts and liver enzymes regularly to detect and manage these events.
Slovenian: - zapleti pri dihanju Zdravnik bo redno nadziral vašo krvno sliko in jetrne encime za odkrivanje in obvladovanje teh učinkov.
English: For instructions on reconstitution and further dilution prior to administration, see section 6.6.
Slovenian: Za dodatna navodila glede rekonstitucije in nadaljnjega razredčevanja pred dajanjem glejte poglavje 6.6.
English: Patients who have received prior radiation therapy, greater than or equal to three cycles of chemotherapy, or prior progenitor cell transplant may be at an increased risk of hepatic veno-occlusive disease (see section 4.8).
Slovenian: Bolniki, ki so prejeli predhodno zdravljenje z obsevanjem, daljše ali enako trem ciklom kemoterapije, ali predhodno presaditev matičnih celic, so lahko bolj izpostavljeni venookluzivni bolezni jeter (glejte poglavje 4.8).
English: Thiotepa was shown to be genotoxic in vitro and in vivo, and carcinogenic in mice and rats.
Slovenian: Tiotepa se je izkazala za genotoksično in vitro in in vivo ter karcinogeno pri miših in podganah.
English: In some cases, relapse rates lower than 40% have also been reported at 5 years and 10 years.
Slovenian: V nekaterih primerih so poročali tudi o stopnjah ponovitve, nižjih od 40 %, za obdobje pet in deset let.
English: GvHD (graft versus host disease): all conditioning treatments evaluated assured a low incidence of acute GvHD grade III-IV (from 4% to 24%).
Slovenian: GvHD (reakcija presadka proti gostitelju): vsa ocenjena pripravljalna zdravljenja so zagotovila majhen pojav akutne GvHD stopnje III-IV (od 4 do 24 %).
English: (10 mg/kg), during the time of the entire conditioning treatment.
Slovenian: (42 mg/kg) v času celotnega pripravljalnega zdravljenja.
English: Do not use TEPADINA after the expiry date which is stated on the carton and vial label, after EXP.
Slovenian: Tega zdravila ne smete uporabljajti po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki na viali, poleg oznake „EXP“.
English: The infusion solution must be administered to patients using an infusion set equipped with a 0.2 µm in-line filter.
Slovenian: Raztopino za infudiranje bolnikom je treba odmeriti s pomočjo infuzijskega kompleta, opremljenega z linijskim filtrom, velikosti 0,2 µm.
English: The most important adverse reactions expected in case of overdose is myeloablation and pancytopenia.
Slovenian: Najpomembnejša neželena učinka v primeru prevelikega odmerjanja sta mieloablacija in pancitopenija.
English: Alkylating chemotherapeutic agents, including thiotepa, inhibit plasma pseudocholinesterase by 35% to 70%.
Slovenian: Alkilirajoči citostatiki, vključno s tiotepo, zavirajo plazemsko psevdoholinesterazo za 35 do 70 %.
English: Concomitant use with live attenuated vaccines (except yellow fever vaccines), phenytoin and fosphenytoin is not recommended (see section 4.5).
Slovenian: Sočasna uporaba z živimi atenuiranimi cepivi (razen cepivi za rumeno mrzlico), fenitoinom in fosfenitoinom ni priporočljiva (glejte poglavje 4.5).
English: Pulmonary arterial hypertension
Slovenian: Pljučna arterijska hipertenzija
English: Thiotepa undergoes rapid and extensive hepatic metabolism and metabolites could be detected in urine within 1 hour after infusion.
Slovenian: Tiotepa se v jetrih hitro in v veliki meri presnovi, metabolite je v urinu mogoče zaznati v eni uri po infundiranju.
English: What TEPADINA is and what it is used for
Slovenian: Kaj je zdravilo TEPADINA in za kaj ga uporabljamo
English: Phenytoin: risk of exacerbation of convulsions resulting from the decrease of phenytoin digestive absorption by cytotoxic medicinal product or risk of toxicity enhancement and loss of efficacy of the cytotoxic medicinal product due to increased hepatic metabolism by phenytoin.
Slovenian: Fenitoin: tveganje poslabšanja konvulzij zaradi slabše absorpcije fenitoina s citotoksičnim zdravilom ali tveganje povečane toksičnosti in izgube učinkovitosti citotoksičnega zdravila zaradi povečane jetrne presnove s fenitoinom.
English: Thiotepa appears to be metabolised via CYP2B6 and CYP3A4.
Slovenian: Zdi se, da se tiotepa presnavlja preko CYP2B6 in CYP3A4.
English: Thiotepa is a weak inhibitor for CYP2B6, and may thereby potentially increase plasma concentrations of substances metabolised via CYP2B6, such as ifosfamide, tamoxifen, bupropion, efavirenz and cyclophosphamide.
Slovenian: Tiotepa je šibak zaviralec CYP2B6 in lahko zato v plazmi potencialno zviša koncentracije snovi, ki se presnavljajo s CYP2B6, kot so ifosfamid, tamoksifen, bupropion, efavirenz in ciklofosfamid.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
English: Severe granulocytopenia, thrombocytopenia, anaemia or any combination thereof may develop.
Slovenian: Razvijejo se lahko huda granulocitopenija, trombocitopenija, anemija ali kombinacija teh.
English: No conventional acute and repeat dose toxicity studies were performed.
Slovenian: Običajne študije akutne toksičnosti in toksičnosti pri ponavljajočih se odmerkih niso bile izvedene.
English: Mental disorder due to a general medical condition
Slovenian: Psihiatrične motnje duševne motnje duševne motnje zaradi splošnega zdravstvenega stanja
English: These include infection and Graft-versus host disease (GvHD) which, although not directly related, were the major causes of morbidity and mortality, especially in allogeneic HPCT.
Slovenian: Posledice zajemajo okužbo in reakcijo presadka proti gostitelju (GVHD: Graft-versus host disease), ki sta bili, čeprav ne neposredno povezani, glavna vzroka obolevnosti in umrljivosti, zlasti pri alogenski PKMC.
English: The identified metabolites TEPA, monochlorotepa and thiotepa-mercapturate are all excreted in the urine.
Slovenian: Ugotovljeni metaboliti TEPA, monoklorotepa in tiotepa-merkapturat se vsi izločajo v urinu.
English: Engraftment: It has been achieved with all evaluated conditioning regimens including thiotepa with a success rate of 96% - 100%.
Slovenian: Sprejem presadka: dosežen je bil pri vseh ocenjenih režimih pripravljalnega zdravljenja s tiotepo, s stopnjo uspešnosti 96 do 100 odstotkov.
English: Contents of the pack and other information What TEPADINA contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo TEPADINA
English: Due to its lack of extramedullary toxicity despite dose escalation beyond myelotoxic doses, thiotepa has been used for decades in combination with other chemotherapy medicinal products prior to autologous and allogeneic HPCT.
Slovenian: Zaradi netoksičnosti izven kostnega mozga kljub stopnjevanju odmerka, ki presega mielotoksične odmerke, se tiotepa že desetletja uporablja v kombinaciji z drugimi kemoterapevtiki pred avtologno in alogensko PKMC.
English: Only colourless solutions, without any particulate matter, must be used.
Slovenian: Uporabijo se lahko le brezbarvne raztopine, brez vidnih delcev.
English: What you need to know before you use TEPADINA Do not use TEPADINA
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo TEPADINA Ne uporabljajte zdravila TEPADINA
English: TEPADINA is for single use only.
Slovenian: Zdravilo TEPADINA je samo za enkratno uporabo.
English: Cases of leukoencephalopathy have been observed following treatment with thiotepa in adult and paediatric patients with multiple previous chemotherapies, including methotrexate and radiotherapy.
Slovenian: Primeri levkoencefalopatije po zdravljenju s tiotepo so bili opaženi pri odraslih in otrocih, ki so v preteklosti prejeli več kemoterapij, vključno z metotreksatom in radioterapijo.
English: As thiotepa and its metabolites are poorly excreted in the urine, dose modification is not recommended in patients with mild or moderate renal insufficiency.
Slovenian: Ker se tiotepa in njeni presnovki slabo izločajo z urinom, prilagoditev odmerka ni potrebna pri bolnikih z blago ali srednjo ledvično insuficienco.
English: As a precautionary measure, women must not breast-feed during treatment with TEPADINA.
Slovenian: Iz previdnostnih razlogov ženske med zdravljenjem z zdravilom TEPADINA ne smejo dojiti.
English: TEPADINA may have major influence on the ability to drive and use machines.
Slovenian: Zdravilo TEPADINA ima lahko pomemben vpliv na sposobnost vožnje in upravljanja s stroji.
English: Live attenuated vaccines (except yellow fever): risk of systemic, possibly fatal disease.
Slovenian: Živa atenuirana cepiva (razen cepiva proti rumeni mrzlici): tveganje sistemske, lahko tudi smrtno nevarne bolezni.
English: Due to its highly myeloablative characteristics, thiotepa enhances recipient immunosuppression and myeloablation, thus strengthening engraftment; this compensates for the loss of the GvHD-related GvL effects.
Slovenian: Zaradi močnih mieloablativnih lastnosti tiotepa okrepi imunosupresijo in mieloablacijo prejemnika, zaradi česar je sprejem presadka okrepljen; to nadomesti izgubo učinka presadka proti levkemiji (učinek GvL), povezanega z GvHD.
English: Not known: frequency cannot be estimated from the available data - increased blood pressure in the arteries (blood vessels) of the lungs (pulmonary arterial hypertension) - severe skin damage (e.g. severe lesions, bullae, etc.) potentially involving the full body surface which can be even life-threatening - damage to a component of the brain (the so called white matter) which can be even lifethreatening (leukoencephalopathy).
Slovenian: Neznana pogostnost: pogostnosti ni mogoče oceniti iz razpoložljivih podatkov - zvišan krvni tlak v arterijah (krvnih žilah) v pljučih (pljučna arterijska hipertenzija) - huda poškodba kože (npr. hude razjede, mehurji itd.), ki lahko vključuje celotno površino telesa in je lahko celo življenjsko nevarna - poškodba dela možganov (t. i. bela možganovina), ki je lahko celo življenjsko nevarna (levkoencefalopatija).
English: Due to its pharmacological properties and its potential toxicity for breast-fed newborns/infants, breast-feeding is contraindicated during treatment with thiotepa.
Slovenian: Zaradi farmakoloških lastnosti in potencialne toksičnosti za dojene novorojenčke/otroke je dojenje kontraindicirano med zdravljenjem s tiotepo.
English: The volume of distribution of thiotepa is large and it has been reported as ranging from 40.8 l/m2 to 75 l/m2, indicating distribution to total body water.
Slovenian: Volumen porazdelitve tiotepe je velik in po poročanju niha med 40,8 l/m2 do 75 l/m2, kar kaže na porazdelitev v vse tekočine v telesu.
English: 20867 Caponago (MB) Italy adienne@adienne.com
Slovenian: 20867 Caponago (MB) Italija adienne@adienne.com
English: TEPADINA should be aseptically administered as a 2-4 hours infusion under room temperature (about 25°C) and normal light conditions.
Slovenian: Zdravilo TEPADINA se daje aseptično kot 2- do 4-urna infuzija pri sobni temperaturi (okrog 25 °C) in pod običajnimi svetlobnimi pogoji.
English: Pharmacotherapeutic group: Antineoplastic agents, Alkylating Agents, ATC code: L01AC01
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), alkilirajoči citostatiki, oznaka ATC: L01AC01
English: It is unknown whether thiotepa is excreted in human milk.
Slovenian: Ni znano, ali se tiotepa izloča v materino mleko.
English: Solid tumours
Slovenian: Čvrsti tumorji
English: Each carton contains 1 vial.
Slovenian: Pakiranje vsebuje 1 vialo.
English: TEPADINA is indicated, in combination with other chemotherapy medicinal products:
Slovenian: Zdravilo TEPADINA se uporablja v kombinaciji z drugimi kemoterapevtiki:
English: Intravenous use, after reconstitution and dilution.
Slovenian: intravenska uporaba, po rekonstituciji in redčenju
English: The conditioning treatment must provide cytoreduction and ideally disease eradication.
Slovenian: Pripravljalno zdravljenje mora zagotoviti citoredukcijo in, v idealnih okoliščinah, izkoreninjenje bolezni.
English: • when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients.
Slovenian: • ko je kemoterapija z visokimi odmerki s podporo PKMC primerna za zdravljenje čvrstih tumorjev pri odraslih in pediatričnih bolnikih.
English: After reconstitution, use within 8 hours when stored in a refrigerator.
Slovenian: Po rekonstituciji uporabite v 8 urah, če je zdravilo shranjeno v hladilniku.
English: After dilution, use within 24 hours when stored in a refrigerator.
Slovenian: Po redčenju uporabite v 24 urah, če je zdravilo shranjeno v hladilniku.
English: For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja rekonstituiranega zdravila in zdravila po redčenju glejte poglavje 6.3.
English: Considering that all patients suffer of recurrence or poor prognosis solid tumours, these rates support the efficacy of conditioning regimens based on thiotepa.
Slovenian: Ob upoštevanju, da je pri vseh bolnikih možna ponovitev čvrstih tumorjev ali gre za čvrste tumorje s predvidenim slabim izidom, te stopnje potrjujejo učinkovitost režimov pripravljalnega zdravljenja na osnovi tiotepe.
English: Posology in paediatric patients
Slovenian: Odmerjanje pri pediatričnih bolnikih
English: The most frequently adverse reactions reported in the different conditioning treatments including thiotepa are: infections, cytopenia, acute GvHD and chronic GvHD, gastrointestinal disorders, haemorrhagic cystitis, mucosal inflammation.
Slovenian: Najpogostejše neželene reakcije pri različnih pripravljalnih zdravljenjih, vključno s tiotepo, o katerih so poročali, so: okužbe, citopenija, akutna GvHD in kronična GvHD, bolezni prebavil, hemoragični cistitis, vnetje sluznice.
English: All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety hood.
Slovenian: Pri vseh prenosih morate strogo upoštevati aseptične pogoje in po možnosti uporabiti zaščitno komoro z navpičnim laminarnim tokom zraka.
English: When treating such patients it is recommended that serum transaminase, alkaline phosphatase and bilirubin are monitored regularly following transplant, for early detection of hepatotoxicity.
Slovenian: Pri zdravljenju takšnih bolnikov se zaradi zgodnjega odkrivanja hepatotoksičnosti priporoča redno spremljanje transaminaze, alkalne fosfataze in bilirubina v serumu po presaditvi.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: In pre-clinical studies thiotepa, as most alkylating agents, has been shown to cause embryofoetal lethality and teratogenicity (see section 5.3).
Slovenian: Predklinične študije so pokazale, da tiotepa, kot večina alkilirajočih učinkovin, povzroča smrt zarodka in plodu in ima teratogene učinke (glejte poglavje 5.3).
English: During conversion of GSH conjugates to N-acetylcysteine conjugates, GSH, cysteinylglycine, and cysteine conjugates are formed.
Slovenian: Med pretvorbo konjugatov GSH (growthstimulating hormone) v konjugate N-acetilcisteina se oblikujejo GSH, cisteinilglicin in konjugati cisteina.
English: Frequency of administration
Slovenian: Pogostost uporabe
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: Ime in naslov proizvajalca (proizvajalcev), odgovornega (odgovornih) za sproščanje serij RIEMSER Pharma GmbH
English: Procedures for proper handling and disposal of anticancer medicinal products must be considered.
Slovenian: Upoštevati morate postopke za pravilno ravnanje in odstranjevanje zdravil proti raku.
English: 20867 Caponago (MB) Italy Tel: +39-02 40700445 adienne@adienne.com
Slovenian: 20867 Caponago (MB) Italija Tel. +39-02 40700445 adienne@adienne.com