natgillin/translations-raw huggingface dataset:
REYATAZ may increase plasma levels of carbamazepine due to CYP3A4 inhibition.
Zdravilo REYATAZ lahko z zaviranjem CYP3A4 zviša vrednosti karbamazepina v plazmi.
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 300 mg of atazanavir (as sulphate).
NAVEDBA ENE ALI VEČ UČINKOVIN Ena kapsula vsebuje 300 mg atazanavirja (v obliki sulfata).
However, REYATAZ is not recommended in patients undergoing haemodialysis (see sections 4.2 and 5.2).
Pri bolnikih, ki se zdravijo s hemodializo, uporaba zdravila REYATAZ ni priporočljiva (glejte poglavji 4.2 in 5.2).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS REYATAZ 50 mg ORAL POWDER - FOIL SACHET 1.
REYATAZ 50 mg PERORALNI PRAŠEK - FOLIJA VREČICE
REYATAZ 100 mg hard capsules are supplied in bottles of 60 capsules.
REYATAZ 100 mg trde kapsule so na voljo v plastenkah s 60 kapsulami.
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 150 mg of atazanavir (as sulphate).
NAVEDBA ENE ALI VEČ UČINKOVIN Ena kapsula vsebuje 150 mg atazanavirja (v obliki sulfata).
REYATAZ 100 mg hard capsules are also supplied in blister strips in packs of 60 capsules.
REYATAZ 100 mg trde kapsule so na voljo tudi v pretisnih omotih s 60 kapsulami.
Co-administration of REYATAZ with products containing St. John's wort is contraindicated.
Sočasna uporaba zdravila REYATAZ in pripravkov s šentjanževko je kontraindicirana.
Aspartame (E951)
6.1 Seznam pomožnih snovi aspartam (E951) saharoza aroma pomaranče in vanilije
What REYATAZ looks like and contents of the pack Each capsule of REYATAZ 200 mg contains 200 mg atazanavir.
Ena kapsula zdravila REYATAZ 200 mg vsebuje 200 mg atazanavirja.
STATEMENT OF ACTIVE SUBSTANCE(S) Each sachet contains 50 mg of atazanavir (as sulphate).
NAVEDBA ENE ALI VEČ UČINKOVIN Ena vrečica vsebuje 50 mg atazanavirja (v obliki sulfata).
Co-administration of nevirapine and REYATAZ is not recommended (see section 4.4)
Sočasne uporabe nevirapina in zdravila REYATAZ ne priporočamo (glejte poglavje 4.4).
Co-administration of salmeterol with REYATAZ/ritonavir is not recommended (see section 4.4).
REYATAZ/ritonavirja se ne priporoča (glejte poglavje 4.4).
c LPV/RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily).
c LPV/RTV skupaj z dizoproksiltenofovirijevim fumaratom/emtricitabinom (fiksni odmerek 300 mg/200 mg tablete enkrat na dan).
REYATAZ with ritonavir is not recommended in patients undergoing haemodialysis (see sections 4.4 and 5.2).
Pri bolnikih, ki se zdravijo s hemodializo, uporaba zdravila REYATAZ z ritonavirjem ni priporočljiva (glejte poglavji 4.4 in 5.2).
ANTI-HCV AGENTS Grazoprevir 200 mg once daily (atazanavir 300 mg / ritonavir 100 mg once daily)
Grazoprevir 200 mg enkrat na dan (atazanavir 300 mg / ritonavir 100 mg enkrat na dan)
REYATAZ oral powder should be stored in the original sachet and should not be opened until ready to use.
Zdravilo REYATAZ peroralni prašek shranjujte v originalni vrečici.
See the "Instructions for use" at the end of the package leaflet for how to prepare and give a dose of REYATAZ oral powder.
Za pripravo in dajanje odmerka zdravila REYATAZ peroralni prašek glejte "Navodila za uporabo" na koncu tega navodila.
For treatment-naive paediatric patients, the mean baseline CD4 cell count was 930 cells/mm3 (range: 46 to 2291 cells/mm3) and mean baseline plasma HIV-1 RNA was 4.81 log10 copies/ml (range: 3.4 to 5.9 log10 copies/ml).
CD4 v izhodišču znašalo 930 celic/mm3 (razpon od 46 do 2.291 celic/mm3), srednja vrednost plazemske HIV-1 RNA v izhodišču pa 4,81 log10 kopij/ml (razpon od 3,4 do 5,9 log10 kopij/ml).
b REYATAZ/RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily).
b Zdravilo REYATAZ/RTV skupaj z dizoproksiltenofovirijevim fumaratom/emtricitabinom (fiksni odmerek 300 mg/200 mg tablete enkrat na dan).
Reduced plasma concentrations of atazanavir may be the consequence of increased gastric pH if antacids, including buffered medicinal products, are administered with REYATAZ.
Pri sočasni uporabi zdravila REYATAZ in antacidov, vključno z zdravili, ki vsebujejo pufre, se zaradi zvišanja vrednosti pH želodčne vsebine lahko zmanjšajo koncentracije atazanavirja.
REYATAZ with ritonavir has not been studied in patients with hepatic impairment.
Pri bolnikih z okvaro jeter uporabe zdravila REYATAZ z ritonavirjem niso proučevali.
What REYATAZ looks like and contents of the pack Each capsule of REYATAZ 100 mg contains 100 mg atazanavir.
Ena kapsula zdravila REYATAZ 100 mg vsebuje 100 mg atazanavirja.
However, REYATAZ with ritonavir is not recommended in patients undergoing haemodialysis (see sections 4.2 and 5.2).
Pri bolnikih, ki se zdravijo s hemodializo, uporaba zdravila REYATAZ z ritonavirjem ni priporočljiva (glejte poglavji 4.2 in 5.2).
229 (n=14
229 (n=14 b)
Phenobarbital and phenytoin should be used with caution in combination with REYATAZ/ritonavir.
Fenobarbital in fenitoin je treba v kombinaciji z zdravilom
ANTIMYCOBACTERIAL Rifabutin 150 mg twice weekly (atazanavir 300 mg and ritonavir 100 mg once daily)
ZDRAVILA ZA ZDRAVLJENJE OKUŽB Z MIKOBAKTERIJAMI Rifabutin 150 mg dvakrat na teden (atazanavir 300 mg in ritonavir 100 mg enkrat na dan)
What REYATAZ looks like and contents of the pack Each capsule of REYATAZ 150 mg contains 150 mg atazanavir.
Izgled zdravila REYATAZ in vsebina pakiranja Ena vrečica zdravila REYATAZ 50 mg peroralni prašek vsebuje 50 mg atazanavirja.
Phenylketonuria
Pomožne snovi Fenilketonurija
No dose adjustment is needed for REYATAZ/ritonavir.
REYATAZ/ritonavirja ni treba prilagajati.
No dosage adjustment is necessary if methadone is coadministered with REYATAZ and ritonavir.
Pri sočasni uporabi metadona, zdravila REYATAZ in ritonavirja odmerkov ni treba prilagajati.
60 hard capsules: EU/1/03/267/004
Pakiranje v pretisnem omotu: 60 trdih kapsul: EU/1/03/267/004
60 hard capsules: EU/1/03/267/006
Pakiranje v pretisnem omotu: 60 trdih kapsul: EU/1/03/267/006
Concentrations of these immunosuppressants may be increased when co-administered with REYATAZ/ritonavir due to CYP3A4 inhibition.
Pri sočasni uporabi z zdravilom REYATAZ/ritonavirjem se zaradi zavrtja CYP3A4 lahko koncentracije teh imunosupresivov povečajo.
60 hard capsules: EU/1/03/267/003
Pakiranje v plastenki: 60 trdih kapsul: EU/1/03/267/003
With Tenofovir disoproxil fumarate 300 mg once daily (equivalent to 245 mg tenofovir disoproxil) In HIV-infected patients with atazanavir/ritonavir at the recommended dose of 300/100 mg once daily
Z dizoproksiltenofovirijevim fumaratom v odmerku 300 mg enkrat na dan (kar ustreza 245 mg dizoproksiltenofovirata)
Also see PULMONARY ATERIAL HYPERTENSION in this table for further information regarding co-administration of REYATAZ/ritonavir with sildenafil.
Za nadaljnje informacije o sočasni uporabi zdravila REYATAZ/ritonavirja in sildenafila glejte tudi PLJUČNA ARTERIJSKA HIPERTENZIJA v tej preglednici.
REYATAZ is expected to increase plasma levels of lurasidone due to CYP3A4 inhibition.
Zdravilo REYATAZ lahko z zaviranjem CYP3A4 zviša vrednosti lurasidona v plazmi.
3 x 30 hard capsules: EU/1/03/267/010
30 trdih kapsul: EU/1/03/267/008 3 x 30 trdih kapsul: EU/1/03/267/010
60 hard capsules: EU/1/03/267/002
Pakiranje v pretisnem omotu: 60 trdih kapsul: EU/1/03/267/002
60 hard capsules: EU/1/03/267/001
Pakiranje v plastenki: 60 trdih kapsul: EU/1/03/267/001
There was no evidence of pathologic jaundice and six of
O znakih patološke zlatenice niso poročali.
Sofosbuvir AUC : ↑40% (↑25% ↑57%) Sofosbuvir Cmax :↑29% (↑9% ↑52%) Velpatasvir AUC: ↑93% (↑58% Velpatasvir Cmax : ↑29% (↑7% ↑56%) Voxilaprevir AUC : ↑331% (↑276% Voxilaprevir Cmax : ↑342% (↑265%
Velpatasvir AUC: ↑93% (↑58% ↑136%) Velpatasvir Cmax: ↑29% (↑7% ↑56%)
Your doctor will discuss this risk with you.
Vaš zdravnik vam bo svetoval glede tega tveganja.
The following information is intended for healthcare professionals only.
Naslednje informacije so namenjene samo zdravstvenemu osebju.
Unopened vial 18 months.
Neodprta viala 18 mesecev
The duration of treatment can last up to 5 days.
Zdravljenje lahko traja do 5 dni.
You will receive your infusions every 12 or 24 hours.
Infuzijo boste prejeli vsakih 12 ali 24 ur.
Some cases had a fatal outcome.
Nekateri primeri so se končali s smrtnim izidom.
Date of first authorisation: 15 March 2010 Date of latest renewal: 15 March 2015
Datum prve odobritve: 15. marec 2010 Datum zadnjega podaljšanja: 15. marec 2015
The haematological recovery is in the expected time.
Hematološka ozdravitev je v pričakovanem času.
The action of succinyl-choline can be prolonged by 5 to 15 minutes.
Delovanje sukcinilholina je mogoče podaljšati za 5 do 15 minut.
Frequency of administration and duration of treatment depend on your disease.
Pogostost uporabe in trajanje zdravljenja sta odvisna od vaše bolezni.
These effects were seen at doses lower than those used in humans.
Ti učinki so bili opaženi pri odmerkih, manjših od odmerkov, uporabljenih pri ljudeh.
However, in clinical studies, a proportion of patients over the age of 65 received the same cumulative dose as the other patients.
V kliničnih študijah pa je delež bolnikov, starejših od 65 let, prejemal enak kumulativni odmerek kot drugi bolniki.
However, caution is recommended (see sections 4.4 and 5.2).
Vendar je potrebna previdnost (glejte poglavji 4.4 in 5.2).
Clinical safety and efficacy
Klinična učinkovitost in varnost
An inactivated virus vaccine should be used instead, whenever possible (poliomyelitis).
Kjer je mogoče, se uporabi inaktivirano virusno cepivo (poliomielitis).
Your doctor will calculate the dose according to your body surface or weight and your disease.
Zdravnik bo izračunal odmerek glede na vašo telesno površino ali telesno maso in vašo bolezen.
No dose adjustment was deemed necessary.
Prilagoditev odmerka se ni zdela potrebna.
TEPADINA may cause another type of cancer in the future.
Zdravilo TEPADINA lahko v prihodnosti povzroči drugo vrsto raka.
The results of published clinical studies supporting the efficacy of thiotepa are summarised:
Rezultati objavljenih kliničnih študij, ki podpirajo učinkovitost tiotepe, so povzeti v nadaljevanju:
This risk is increased in subjects who are already immunosuppressed by their underlying disease.
Tveganje je večje pri osebah, ki so že imunsko oslabljeni zaradi osnovne bolezni.
Further dilution in the infusion bag
Nadaljnje redčenje v infuzijski vrečki
Filtering does not alter solution potency.
Filtriranje ne spremeni učinkovitosti raztopine.
In these studies, a total of 6,588 adult patients and 902 paediatric patients received thiotepa for conditioning treatment prior to haematopoietic progenitor cell transplantation.
V teh študijah je 6 588 odraslih bolnikov in 902 pediatrična bolnika prejelo tiotepo kot pripravljalno zdravljenje pred presaditvijo krvotvornih matičnih celic.
Therefore, thiotepa is contraindicated during pregnancy.
Zato je tiotepa kontraindicirana med nosečnostjo.
The apparent volume of distribution of thiotepa appears independent of the administered dose.
Navidezni volumen porazdelitve tiotepe se zdi neodvisen od uporabljenega odmerka.
The haematological status needs to be closely monitored and vigorous supportive measures instituted as medically indicated.
Hematološki status je treba pozorno spremljati in vzpostaviti učinkovite podporne ukrepe, kadar so prisotne zdravstvene indikacije.
Engraftment: Engraftment has been achieved (92%-100%) in all reported conditioning treatments and it was considered to occur at the expected time.
Sprejem presadka: sprejem je bil dosežen (92 % do 100 %) pri vseh pripravljalnih zdravljenjih, o katerih so poročali, in veljalo je, da je do njega prišlo v pričakovanem času.
Each infusion will last 2-4 hours.
Vsako infundiranje traja 2 do 4 ure.
The pharmacokinetics of high dose thiotepa in children between 2 and 12 years of age do not appear to vary from those reported in children receiving 75 mg/m2 or adults receiving similar doses.
Farmakokinetika tiotepe v visokih odmerkih pri otrocih starih 2 do 12 let ne razlikuje od tiste, o kateri so poročali pri otrocih, ki so prejemali 75 mg/m2 , ali odraslih, ki so prejemali podobne odmerke.
This enables the transplantation of new bone marrow cells (haematopoietic progenitor cells), which in turn enable the body to produce healthy blood cells.
To omogoči presaditev novih celic kostnega mozga (krvotvornih matičnih celic), ki v telesu omogočijo nastajanje zdravih krvnih celic.
The safety of thiotepa has been examined through a review of adverse events reported in published data from clinical trials.
Varnost tiotepe je bila preverjena s pregledom neželenih učinkov, o katerih so poročali v objavljenih podatkih iz kliničnih študij.
The elimination half-life varied from 1.5 to 4.1 hours.
Razpolovna doba eliminacije je bila od 1,5 do 4,1 ure.
It is not known whether this medicinal product is excreted in breast milk.
Ni znano, ali se to zdravilo izloča v materino mleko.
Due to the increase of thrombotic risk in case of malignancy, the use of anticoagulative treatment is frequent.
Zaradi povečanega tveganja za trombozo v primeru malignosti je antikoagulacijsko zdravljenje pogosto.
In order to prevent and manage infections, you will be given anti-infectives.
Za preprečevanje in obvladovanje okužb boste dobili zdravila proti okužbam.
The fraction unbound to proteins in plasma is 70-90%; insignificant binding of thiotepa to gamma globulin and minimal albumin binding (10-30%) has been reported.
Nevezane frakcije na beljakovine v plazmi je 70-90 %; poročali so o nepomembni vezavi tiotepe na gama globulin in o minimalni vezavi na albumin (10-30 %).
If you get any side effects, talk to your doctor or nurse.
Če opazite kateri koli izmed neželenih učinkov, se posvetujte z zdravnikom ali medicinsko sestro.
During the concomitant use of thiotepa and inhibitors of CYP2B6 or CYP3A4, patients should be carefully monitored clinically (see section 4.5).
Med sočasno uporabo tiotepe in zaviralcev CYP2B6 ali CYP3A4 je treba bolnike pozorno klinično spremljati (glejte poglavje 4.5).
Thiotepa is a highly lipophilic compound.
Tiotepa je močno lipofilna spojina.
You must tell your doctor if you are pregnant or you think you may be pregnant before you receive TEPADINA.
Obvestite svojega zdravnika, če ste noseči ali menite, da ste, preden prejmete zdravilo TEPADINA.
Serious toxicities involving the haematologic, hepatic and respiratory systems were considered as expected consequences of the conditioning regimen and transplant process.
Hude toksičnosti v povezavi s hematološkim, jetrnim in dihalnim sistemom so bile pričakovane posledice režima pripravljalnega zdravljenja in procesa presaditve.
There is no known antidote for thiotepa.
Za tiotepo ni znanega antidota.
Inject the content of the syringe into the vial through the rubber stopper.
Injicirajte vsebino brizge v vialo skozi gumijasti zamašek.
Prophylactic or empiric use of anti-infectives (bacterial, fungal, viral) should be considered for the prevention and management of infections during the neutropenic period.
Preventivna ali empirična uporaba zdravil proti okužbam (bakterijskim, glivičnim, virusnim) je priporočljiva za preprečevanje in obvladovanje okužb v obdobju nevtropenije.
Dose modification is not recommended for transient alterations of hepatic parameters (see section 4.4).
Prilagoditev odmerka ni potrebna pri prehodnih spremembah jetrnih parametrov (glejte poglavje 4.4).
- 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.
- če ste noseči ali menite, da ste, - če dojite, - če prejemate cepivo za rumeno mrzlico, cepiva z živimi virusi in bakterijska cepiva.
Remove the syringe and the needle and mix manually by repeated inversions.
Odstranite brizgo in iglo ter ročno premešajte tako, da vialo večkrat obrnete.
The metabolites are active alkylating agents but the role they play in the antitumor activity of thiotepa remains to be elucidated.
Metaboliti so aktivne alkilirajoče snovi, a vlogo, ki jo imajo pri protitumorski aktivnosti tiotepe, je treba še pojasniti.
Women of childbearing potential have to use effective contraception during treatment and a pregnancy test should be performed before treatment is started.
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem, pred vsakim zdravljenjem pa je treba opraviti test nosečnosti.
These metabolites are not found in urine, and, if formed, are probably excreted in bile or as intermediate metabolites rapidly converted into thiotepa-mercapturate.
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.
Concomitant use with yellow fever vaccine and with live virus and bacterial vaccines (see section 4.5).
Sočasna uporaba s cepivom za rumeno mrzlico in z živimi virusnimi in bakterijskimi cepivi (glejte poglavje 4.5).
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.
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.
Both women and men using TEPADINA must use effective contraceptive methods during treatment.
Ženske in moški, ki uporabljajo zdravilo TEPADINA, morajo med zdravljenjem uporabljati učinkovite metode kontracepcije.
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.
Povprečni urinarni izplen tiotepe in njenih presnovkov je 0,5 % za nespremenjeno zdravilo in monoklorotepo ter 11 % za TEPA in tiotepo-merkapturat.
Urinary excretion of thiotepa and TEPA is nearly complete after 6 and 8 hours respectively.
Izločanje tiotepe in TEPA v urinu je skoraj popolno po 6 oziroma 8 urah.
RIEMSER Pharma GmbH Bahnhofstraße 44b 17489 Greifswald Germany
RIEMSER Pharma GmbH Bahnhofstraße 44b 17489 Greifswald
These data support the efficacy of conditioning regimens based on thiotepa in all haematological diseases.
Ti podatki potrjujejo učinkovitost režimov pripravljalnega zdravljenja na osnovi tiotepe pri vseh hematoloških boleznih.
After intravenous administration, plasma concentrations of the active substance fit a two compartment model with a rapid distribution phase.
Po intravenskem dajanju koncentracije zdravilne učinkovine v plazmi ustrezajo modelu z dvema predelkoma s hitro fazo porazdelitve.
There are no data on the use of thiotepa during pregnancy.
Ni podatkov o uporabi tiotepe med nosečnostjo.
Reconstituted solutions may occasionally show opalescence; such solutions can still be administered.
Rekonstituirane raztopine so lahko občasno opalescentne, vendar jih lahko kljub temu uporabite.
The total clearance of thiotepa ranged from 11.4 to 23.2 l/h/m2.
Celotni očistek tiotepe je bil med 11,4 do 23,2 l/h/m2.
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.
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.
GENETIC DISEASES
GENETSKE BOLEZNI
Previous brain irradiation or craniospinal irradiation may contribute to severe toxic reactions (e.g. encephalopathy).
Predhodno obsevanje možganov ali kraniospinalnega predela lahko pripomore k hudim toksičnim učinkom (npr. encefalopatiji).
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.
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.
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.
Skupna izločena količina tiotepe in njenih ugotovljenih metabolitov predstavljajo 54-100 % vse alkilirajoče aktivnosti, kar kaže na prisotnost še drugih alkilirajočih metabolitov.
TEPADINA can be used in adults and children and adolescents.
Zdravilo TEPADINA se uporablja pri odraslih, otrocih in mladostnikih.
Your doctor will monitor your blood counts and liver enzymes regularly to detect and manage these events.
- zapleti pri dihanju Zdravnik bo redno nadziral vašo krvno sliko in jetrne encime za odkrivanje in obvladovanje teh učinkov.
For instructions on reconstitution and further dilution prior to administration, see section 6.6.
Za dodatna navodila glede rekonstitucije in nadaljnjega razredčevanja pred dajanjem glejte poglavje 6.6.
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).
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).
Thiotepa was shown to be genotoxic in vitro and in vivo, and carcinogenic in mice and rats.
Tiotepa se je izkazala za genotoksično in vitro in in vivo ter karcinogeno pri miših in podganah.
In some cases, relapse rates lower than 40% have also been reported at 5 years and 10 years.
V nekaterih primerih so poročali tudi o stopnjah ponovitve, nižjih od 40 %, za obdobje pet in deset let.
GvHD (graft versus host disease): all conditioning treatments evaluated assured a low incidence of acute GvHD grade III-IV (from 4% to 24%).
GvHD (reakcija presadka proti gostitelju): vsa ocenjena pripravljalna zdravljenja so zagotovila majhen pojav akutne GvHD stopnje III-IV (od 4 do 24 %).
(10 mg/kg), during the time of the entire conditioning treatment.
(42 mg/kg) v času celotnega pripravljalnega zdravljenja.
Do not use TEPADINA after the expiry date which is stated on the carton and vial label, after EXP.
Tega zdravila ne smete uporabljajti po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki na viali, poleg oznake „EXP“.
The infusion solution must be administered to patients using an infusion set equipped with a 0.2 µm in-line filter.
Raztopino za infudiranje bolnikom je treba odmeriti s pomočjo infuzijskega kompleta, opremljenega z linijskim filtrom, velikosti 0,2 µm.
The most important adverse reactions expected in case of overdose is myeloablation and pancytopenia.
Najpomembnejša neželena učinka v primeru prevelikega odmerjanja sta mieloablacija in pancitopenija.
Alkylating chemotherapeutic agents, including thiotepa, inhibit plasma pseudocholinesterase by 35% to 70%.
Alkilirajoči citostatiki, vključno s tiotepo, zavirajo plazemsko psevdoholinesterazo za 35 do 70 %.
Concomitant use with live attenuated vaccines (except yellow fever vaccines), phenytoin and fosphenytoin is not recommended (see section 4.5).
Sočasna uporaba z živimi atenuiranimi cepivi (razen cepivi za rumeno mrzlico), fenitoinom in fosfenitoinom ni priporočljiva (glejte poglavje 4.5).
Pulmonary arterial hypertension
Pljučna arterijska hipertenzija
Thiotepa undergoes rapid and extensive hepatic metabolism and metabolites could be detected in urine within 1 hour after infusion.
Tiotepa se v jetrih hitro in v veliki meri presnovi, metabolite je v urinu mogoče zaznati v eni uri po infundiranju.
What TEPADINA is and what it is used for
Kaj je zdravilo TEPADINA in za kaj ga uporabljamo