FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, REYATAZ is contraindicated with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index: quetiapine, lurasidone, alfuzosin, astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, triazolam, orally administered midazolam, and ergot alkaloids, particularly ergotamine and dihydroergotamine (see section 4.3).
Slovenian: Zato je kontraindicirana uporaba zdravila REYATAZ z zdravili, ki so substrati za CYP3A4 in imajo ozek terapevtski indeks, npr. kvetiapin, lurasidon, alfuzosin, astemizol, terfenadin, cisaprid, pimozid, kinidin, bepridil, triazolam, peroralne oblike midazolama in alkaloidi ergot, zlasti ergotamin in dihidroergotamin (glejte poglavje 4.3).
English: REYATAZ/ritonavir, especially when commencing therapy.
Slovenian: REYATAZ/ritonavirjem priporočamo skrben nadzor vrednosti INR, še posebej ob uvedbi zdravljenja.
English: Atazanavir Cmax ↔5% (↓17% ↑8.4%)* Atazanavir Cmin ↔1.3% (↓10% ↑15)*
Slovenian: Atazanavir AUC ↔2,3% (↓13% ↑10%)* Atazanavir Cmax ↔5% (↓17% ↑8,4%)* Atazanavir Cmin ↔1,3% (↓10% ↑15%) *
English: NAME OF THE MEDICINAL PRODUCT REYATAZ 200 mg hard capsules atazanavir
Slovenian: IME ZDRAVILA REYATAZ 200 mg trde kapsule atazanavir
English: REYATAZ 100 mg hard capsules atazanavir
Slovenian: REYATAZ 100 mg trde kapsule atazanavir
English: Co-administration of REYATAZ/ritonavir and indinavir is not recommended (see section 4.4).
Slovenian: Sočasne uporabe zdravila REYATAZ/ritonavirja in indinavirja se ne priporoča (glejte poglavje 4.4).
English: Co-administration of alfuzosin with REYATAZ is contraindicated (see section 4.3)
Slovenian: Sočasna uporaba alfuzosina z zdravilom REYATAZ je kontraindicirana (glejte poglavje 4.3).
English: REYATAZ 200 mg hard capsules atazanavir
Slovenian: REYATAZ 200 mg trde kapsule atazanavir
English: HCV Protease Inhibitors Boceprevir 800 mg three times daily (atazanavir 300 mg/ritonavir 100 mg once daily)
Slovenian: Zaviralci HCV proteaz Boceprevir 800 mg trikrat na dan (atazanavir
English: Each capsule contains 300 mg of atazanavir (as sulphate).
Slovenian: Ena kapsula vsebuje 300 mg atazanavirja (v obliki sulfata).
English: REYATAZ 200 mg hard capsules are also supplied in blister strips in packs of 60 capsules.
Slovenian: REYATAZ 200 mg trde kapsule so na voljo tudi v pretisnih omotih s 60 kapsulami.
English: Each capsule contains 100 mg of atazanavir (as sulphate).
Slovenian: Ena kapsula vsebuje 100 mg atazanavirja (v obliki sulfata).
English: The residual mixture is drawn up into the syringe and administered into either the right or left inner cheek of the infant.
Slovenian: Preostalo mešanico izvlecite v brizgo in jo iztisnite otroku v usta v smeri proti desnemu ali levemu licu.
English: No recommendation regarding dose reduction can be made; therefore, caution should be exercised if
Slovenian: Priporočil za zmanjšanje odmerka ne moremo podati.
English: the mean baseline CD4 cell count was 344 cells/mm3 (range: 2 to 800 cells/ mm3) and mean baseline plasma HIV-1 RNA was 4.67 log10 copies/ml (range: 3.70 to 5.00 log10 copies/ml).
Slovenian: 344 celic/mm3 (območje: 2 do 800 celic/mm3) in povprečna začetna plazemska vrednost HIV-1 RNA 4,67 log10 kopij/ml (območje: 3,70 do 5,00 log10 kopij/ml).
English: Cholelithiasis has been reported in patients receiving REYATAZ (see section 4.8).
Slovenian: Pri bolnikih, ki so se zdravili z zdravilom REYATAZ, so poročali o pojavu holelitiaze (glejte poglavje 4.8).
English: REYATAZ 300 mg hard capsules atazanavir
Slovenian: REYATAZ 300 mg trde kapsule atazanavir
English: NAME OF THE MEDICINAL PRODUCT REYATAZ 300 mg hard capsules atazanavir
Slovenian: IME ZDRAVILA REYATAZ 300 mg trde kapsule atazanavir
English: Voriconazole 50 mg twice daily (atazanavir 300 mg/ritonavir 100 mg once daily)
Slovenian: Vorikonazol 50 mg dvakrat na dan (atazanavir 300 mg/ritonavir 100 mg enkrat na dan)
English: NAME OF THE MEDICINAL PRODUCT REYATAZ 100 mg hard capsules atazanavir
Slovenian: IME ZDRAVILA REYATAZ 100 mg trde kapsule atazanavir
English: ANTIFUNGALS Ketoconazole 200 mg once daily (atazanavir 400 mg once daily)
Slovenian: ZDRAVILA ZA ZDRAVLJENJE GLIVIČNIH OKUŽB Ketokonazol 200 mg enkrat na dan (atazanavir 400 mg enkrat na dan)
English: The mean baseline CD4 cell count was 214 cells/mm3 (range: 2 to 810 cells/mm3) and mean baseline plasma HIV-1 RNA was 4.94 log10 copies/ml (range: 2.6 to 5.88 log10 copies/ml).
Slovenian: Srednje število celic CD4 v izhodišču je bilo 214 celic/mm3 (razpon od 2 do 810 celic/mm3), srednja vrednost plazemske HIV-1 RNA v izhodišču pa 4,94 log10 kopij/ml (razpon od 2,6 do 5,88 log10 kopij/ml).
English: For treatment-naive paediatric patients,
Slovenian: Pri predhodno nezdravljenih pediatričnih bolnikih je srednje število celic
English: b ATV/RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily).
Slovenian: b ATV/RTV skupaj z dizoproksiltenofovirijevim fumaratom/emtricitabinom (fiksni odmerek 300 mg/200 mg tablete enkrat na dan).
English: Therefore, REYATAZ with ritonavir is contraindicated with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index: quetiapine, lurasidone, alfuzosin, astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, triazolam, orally administered midazolam, and ergot alkaloids, particularly ergotamine and dihydroergotamine (see section 4.3).
Slovenian: Zato je kontraindicirana uporaba kombinacije zdravila REYATAZ in ritonavirja z zdravili, ki so substrati za CYP3A4 in imajo ozek terapevtski indeks, npr. kvetiapin, lurasidon, alfuzosin, astemizol, terfenadin, cisaprid, pimozid, kinidin, bepridil, triazolam, peroralne oblike midazolama in alkaloidi ergot, zlasti ergotamin in dihidroergotamin (glejte poglavje 4.3).
English: Voriconazole 200 mg twice daily (atazanavir 300 mg/ritonavir 100 mg once daily)
Slovenian: Vorikonazol 200 mg dvakrat na dan (atazanavir 300 mg/ritonavir 100 mg enkrat na dan)
English: REYATAZ 150 mg hard capsules are supplied in bottles of 60 capsules.
Slovenian: REYATAZ 150 mg trde kapsule so na voljo v plastenkah s 60 kapsulami.
English: Also see PULMONARY ARTERIAL HYPERTENSION in this table for further information regarding coadministration of REYATAZ with sildenafil.
Slovenian: Za nadaljnje informacije o sočasni uporabi zdravila REYATAZ in sildenafila glejte tudi PLJUČNA ARTERIJSKA HIPERTENZIJA v tej preglednici.
English: Each capsule contains 150 mg of atazanavir (as sulphate).
Slovenian: Ena kapsula vsebuje 150 mg atazanavirja (v obliki sulfata).
English: Co-administration of REYATAZ/ritonavir with products containing St. John's wort is contraindicated.
Slovenian: Sočasna uporaba zdravila REYATAZ/ritonavirja in pripravkov s šentjanževko je kontraindicirana.
English: Blister pack:
Slovenian: Pakiranje v plastenki:
English: Nephrolithiasis has been reported in patients receiving REYATAZ (see section 4.8).
Slovenian: Pri bolnikih, ki so se zdravili z zdravilom REYATAZ, so poročali o pojavu nefrolitiaze (glejte poglavje 4.8).
English: c Lopinavir/RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily).
Slovenian: c Lopinavir/RTV skupaj z dizoproksiltenofovirijevim fumaratom/emtricitabinom (fiksni odmerek 300 mg/200 mg tablete enkrat na dan).
English: Co-administration of salmeterol with REYATAZ is not recommended (see section 4.4).
Slovenian: Sočasna uporaba salmeterola in zdravila REYATAZ ni priporočljiva (glejte poglavje 4.4).
English: ANTIEPILEPTICS
Slovenian: HORMONSKI KONTRACEPTIVI
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 200 mg of atazanavir (as sulphate).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena kapsula vsebuje 200 mg atazanavirja (v obliki sulfata).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 100 mg of atazanavir (as sulphate).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena kapsula vsebuje 100 mg atazanavirja (v obliki sulfata).
English: REYATAZ with ritonavir should be used with caution in patients with mild hepatic impairment.
Slovenian: Pri bolnikih z blago okvaro jeter je treba zdravilo REYATAZ z ritonavirjem uporabljati previdno.
English: Atazanavir AUC ↑43% (↑30% ↑57%) Atazanavir Cmax ↑12% (↑1% ↑24%) Atazanavir Cmin ↑23% (↑13% ↑134%) Grazoprevir AUC: ↑958% (↑678% Grazoprevir Cmax: ↑524% (↑342% Grazoprevir Cmin: ↑1064% (↑696%
Slovenian: Grazoprevir AUC: ↑958% (↑678% ↑1339%) Grazoprevir Cmax: ↑524% (↑342% ↑781%) Grazoprevir Cmin: ↑1064% (↑696% ↑1602%)
English: Co-administration of REYATAZ with voxilaprevir-containing regimens is not recommended.
Slovenian: Sočasna uporaba zdravila REYATAZ in zdravil, ki vsebujejo voksilaprevir, ni priporočljiva.
English: REYATAZ 200 mg hard capsules are supplied in bottles of 60 capsules.
Slovenian: REYATAZ 200 mg trde kapsule so na voljo v plastenkah s 60 kapsulami.
English: REYATAZ may increase plasma levels of carbamazepine due to CYP3A4 inhibition.
Slovenian: Zdravilo REYATAZ lahko z zaviranjem CYP3A4 zviša vrednosti karbamazepina v plazmi.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 300 mg of atazanavir (as sulphate).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena kapsula vsebuje 300 mg atazanavirja (v obliki sulfata).
English: However, REYATAZ is not recommended in patients undergoing haemodialysis (see sections 4.2 and 5.2).
Slovenian: Pri bolnikih, ki se zdravijo s hemodializo, uporaba zdravila REYATAZ ni priporočljiva (glejte poglavji 4.2 in 5.2).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS REYATAZ 50 mg ORAL POWDER - FOIL SACHET 1.
Slovenian: REYATAZ 50 mg PERORALNI PRAŠEK - FOLIJA VREČICE
English: REYATAZ 100 mg hard capsules are supplied in bottles of 60 capsules.
Slovenian: REYATAZ 100 mg trde kapsule so na voljo v plastenkah s 60 kapsulami.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 150 mg of atazanavir (as sulphate).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena kapsula vsebuje 150 mg atazanavirja (v obliki sulfata).
English: REYATAZ 100 mg hard capsules are also supplied in blister strips in packs of 60 capsules.
Slovenian: REYATAZ 100 mg trde kapsule so na voljo tudi v pretisnih omotih s 60 kapsulami.
English: Co-administration of REYATAZ with products containing St. John's wort is contraindicated.
Slovenian: Sočasna uporaba zdravila REYATAZ in pripravkov s šentjanževko je kontraindicirana.
English: Aspartame (E951)
Slovenian: 6.1 Seznam pomožnih snovi aspartam (E951) saharoza aroma pomaranče in vanilije
English: What REYATAZ looks like and contents of the pack Each capsule of REYATAZ 200 mg contains 200 mg atazanavir.
Slovenian: Ena kapsula zdravila REYATAZ 200 mg vsebuje 200 mg atazanavirja.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each sachet contains 50 mg of atazanavir (as sulphate).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena vrečica vsebuje 50 mg atazanavirja (v obliki sulfata).
English: Co-administration of nevirapine and REYATAZ is not recommended (see section 4.4)
Slovenian: Sočasne uporabe nevirapina in zdravila REYATAZ ne priporočamo (glejte poglavje 4.4).
English: Co-administration of salmeterol with REYATAZ/ritonavir is not recommended (see section 4.4).
Slovenian: REYATAZ/ritonavirja se ne priporoča (glejte poglavje 4.4).
English: c LPV/RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily).
Slovenian: c LPV/RTV skupaj z dizoproksiltenofovirijevim fumaratom/emtricitabinom (fiksni odmerek 300 mg/200 mg tablete enkrat na dan).
English: REYATAZ with ritonavir is not recommended in patients undergoing haemodialysis (see sections 4.4 and 5.2).
Slovenian: Pri bolnikih, ki se zdravijo s hemodializo, uporaba zdravila REYATAZ z ritonavirjem ni priporočljiva (glejte poglavji 4.4 in 5.2).
English: ANTI-HCV AGENTS Grazoprevir 200 mg once daily (atazanavir 300 mg / ritonavir 100 mg once daily)
Slovenian: Grazoprevir 200 mg enkrat na dan (atazanavir 300 mg / ritonavir 100 mg enkrat na dan)
English: REYATAZ oral powder should be stored in the original sachet and should not be opened until ready to use.
Slovenian: Zdravilo REYATAZ peroralni prašek shranjujte v originalni vrečici.
English: See the "Instructions for use" at the end of the package leaflet for how to prepare and give a dose of REYATAZ oral powder.
Slovenian: Za pripravo in dajanje odmerka zdravila REYATAZ peroralni prašek glejte "Navodila za uporabo" na koncu tega navodila.
English: 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).
Slovenian: 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).
English: b REYATAZ/RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily).
Slovenian: b Zdravilo REYATAZ/RTV skupaj z dizoproksiltenofovirijevim fumaratom/emtricitabinom (fiksni odmerek 300 mg/200 mg tablete enkrat na dan).
English: Reduced plasma concentrations of atazanavir may be the consequence of increased gastric pH if antacids, including buffered medicinal products, are administered with REYATAZ.
Slovenian: Pri sočasni uporabi zdravila REYATAZ in antacidov, vključno z zdravili, ki vsebujejo pufre, se zaradi zvišanja vrednosti pH želodčne vsebine lahko zmanjšajo koncentracije atazanavirja.
English: REYATAZ with ritonavir has not been studied in patients with hepatic impairment.
Slovenian: Pri bolnikih z okvaro jeter uporabe zdravila REYATAZ z ritonavirjem niso proučevali.
English: Famotidine 20 mg twice daily Atazanavir AUC ↓18% (↓25% ↑1%) Atazanavir Cmax ↓20% (↓32% ↓7%)
Slovenian: Atazanavir AUC ↓18% (↓25% ↑1%) Atazanavir Cmax ↓20% (↓32% ↓7%) Atazanavir Cmin ↔1% (↓16% ↑18%)
English: What REYATAZ looks like and contents of the pack Each capsule of REYATAZ 100 mg contains 100 mg atazanavir.
Slovenian: Ena kapsula zdravila REYATAZ 100 mg vsebuje 100 mg atazanavirja.
English: However, REYATAZ with ritonavir is not recommended in patients undergoing haemodialysis (see sections 4.2 and 5.2).
Slovenian: Pri bolnikih, ki se zdravijo s hemodializo, uporaba zdravila REYATAZ z ritonavirjem ni priporočljiva (glejte poglavji 4.2 in 5.2).
English: 229 (n=14
Slovenian: 229 (n=14 b)
English: Phenobarbital and phenytoin should be used with caution in combination with REYATAZ/ritonavir.
Slovenian: Fenobarbital in fenitoin je treba v kombinaciji z zdravilom
English: ANTIMYCOBACTERIAL Rifabutin 150 mg twice weekly (atazanavir 300 mg and ritonavir 100 mg once daily)
Slovenian: ZDRAVILA ZA ZDRAVLJENJE OKUŽB Z MIKOBAKTERIJAMI Rifabutin 150 mg dvakrat na teden (atazanavir 300 mg in ritonavir 100 mg enkrat na dan)
English: What REYATAZ looks like and contents of the pack Each capsule of REYATAZ 150 mg contains 150 mg atazanavir.
Slovenian: Izgled zdravila REYATAZ in vsebina pakiranja Ena vrečica zdravila REYATAZ 50 mg peroralni prašek vsebuje 50 mg atazanavirja.
English: Phenylketonuria
Slovenian: Pomožne snovi Fenilketonurija
English: No dose adjustment is needed for REYATAZ/ritonavir.
Slovenian: REYATAZ/ritonavirja ni treba prilagajati.
English: No dosage adjustment is necessary if methadone is coadministered with REYATAZ and ritonavir.
Slovenian: Pri sočasni uporabi metadona, zdravila REYATAZ in ritonavirja odmerkov ni treba prilagajati.
English: 60 hard capsules: EU/1/03/267/004
Slovenian: Pakiranje v pretisnem omotu: 60 trdih kapsul: EU/1/03/267/004
English: 60 hard capsules: EU/1/03/267/006
Slovenian: Pakiranje v pretisnem omotu: 60 trdih kapsul: EU/1/03/267/006
English: Concentrations of these immunosuppressants may be increased when co-administered with REYATAZ/ritonavir due to CYP3A4 inhibition.
Slovenian: Pri sočasni uporabi z zdravilom REYATAZ/ritonavirjem se zaradi zavrtja CYP3A4 lahko koncentracije teh imunosupresivov povečajo.
English: 60 hard capsules: EU/1/03/267/003
Slovenian: Pakiranje v plastenki: 60 trdih kapsul: EU/1/03/267/003
English: 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
Slovenian: Z dizoproksiltenofovirijevim fumaratom v odmerku 300 mg enkrat na dan (kar ustreza 245 mg dizoproksiltenofovirata)
English: Also see PULMONARY ATERIAL HYPERTENSION in this table for further information regarding co-administration of REYATAZ/ritonavir with sildenafil.
Slovenian: Za nadaljnje informacije o sočasni uporabi zdravila REYATAZ/ritonavirja in sildenafila glejte tudi PLJUČNA ARTERIJSKA HIPERTENZIJA v tej preglednici.
English: REYATAZ is expected to increase plasma levels of lurasidone due to CYP3A4 inhibition.
Slovenian: Zdravilo REYATAZ lahko z zaviranjem CYP3A4 zviša vrednosti lurasidona v plazmi.
English: 3 x 30 hard capsules: EU/1/03/267/010
Slovenian: 30 trdih kapsul: EU/1/03/267/008 3 x 30 trdih kapsul: EU/1/03/267/010
English: 60 hard capsules: EU/1/03/267/002
Slovenian: Pakiranje v pretisnem omotu: 60 trdih kapsul: EU/1/03/267/002
English: 60 hard capsules: EU/1/03/267/001
Slovenian: Pakiranje v plastenki: 60 trdih kapsul: EU/1/03/267/001
English: There was no evidence of pathologic jaundice and six of
Slovenian: O znakih patološke zlatenice niso poročali.
English: 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%
Slovenian: Velpatasvir AUC: ↑93% (↑58% ↑136%) Velpatasvir Cmax: ↑29% (↑7% ↑56%)
English: Your doctor will discuss this risk with you.
Slovenian: Vaš zdravnik vam bo svetoval glede tega tveganja.
English: The following information is intended for healthcare professionals only.
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju.
English: Unopened vial 18 months.
Slovenian: Neodprta viala 18 mesecev
English: The duration of treatment can last up to 5 days.
Slovenian: Zdravljenje lahko traja do 5 dni.
English: You will receive your infusions every 12 or 24 hours.
Slovenian: Infuzijo boste prejeli vsakih 12 ali 24 ur.
English: Some cases had a fatal outcome.
Slovenian: Nekateri primeri so se končali s smrtnim izidom.
English: Date of first authorisation: 15 March 2010 Date of latest renewal: 15 March 2015
Slovenian: Datum prve odobritve: 15. marec 2010 Datum zadnjega podaljšanja: 15. marec 2015
English: The haematological recovery is in the expected time.
Slovenian: Hematološka ozdravitev je v pričakovanem času.
English: The action of succinyl-choline can be prolonged by 5 to 15 minutes.
Slovenian: Delovanje sukcinilholina je mogoče podaljšati za 5 do 15 minut.
English: Frequency of administration and duration of treatment depend on your disease.
Slovenian: Pogostost uporabe in trajanje zdravljenja sta odvisna od vaše bolezni.
English: These effects were seen at doses lower than those used in humans.
Slovenian: Ti učinki so bili opaženi pri odmerkih, manjših od odmerkov, uporabljenih pri ljudeh.
English: However, in clinical studies, a proportion of patients over the age of 65 received the same cumulative dose as the other patients.
Slovenian: V kliničnih študijah pa je delež bolnikov, starejših od 65 let, prejemal enak kumulativni odmerek kot drugi bolniki.
English: However, caution is recommended (see sections 4.4 and 5.2).
Slovenian: Vendar je potrebna previdnost (glejte poglavji 4.4 in 5.2).
English: Clinical safety and efficacy
Slovenian: Klinična učinkovitost in varnost
English: An inactivated virus vaccine should be used instead, whenever possible (poliomyelitis).
Slovenian: Kjer je mogoče, se uporabi inaktivirano virusno cepivo (poliomielitis).
English: Your doctor will calculate the dose according to your body surface or weight and your disease.
Slovenian: Zdravnik bo izračunal odmerek glede na vašo telesno površino ali telesno maso in vašo bolezen.
English: No dose adjustment was deemed necessary.
Slovenian: Prilagoditev odmerka se ni zdela potrebna.
English: TEPADINA may cause another type of cancer in the future.
Slovenian: Zdravilo TEPADINA lahko v prihodnosti povzroči drugo vrsto raka.
English: The results of published clinical studies supporting the efficacy of thiotepa are summarised:
Slovenian: Rezultati objavljenih kliničnih študij, ki podpirajo učinkovitost tiotepe, so povzeti v nadaljevanju:
English: This risk is increased in subjects who are already immunosuppressed by their underlying disease.
Slovenian: Tveganje je večje pri osebah, ki so že imunsko oslabljeni zaradi osnovne bolezni.
English: Further dilution in the infusion bag
Slovenian: Nadaljnje redčenje v infuzijski vrečki
English: Filtering does not alter solution potency.
Slovenian: Filtriranje ne spremeni učinkovitosti raztopine.
English: 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.
Slovenian: V teh študijah je 6 588 odraslih bolnikov in 902 pediatrična bolnika prejelo tiotepo kot pripravljalno zdravljenje pred presaditvijo krvotvornih matičnih celic.
English: Therefore, thiotepa is contraindicated during pregnancy.
Slovenian: Zato je tiotepa kontraindicirana med nosečnostjo.
English: The apparent volume of distribution of thiotepa appears independent of the administered dose.
Slovenian: Navidezni volumen porazdelitve tiotepe se zdi neodvisen od uporabljenega odmerka.
English: The haematological status needs to be closely monitored and vigorous supportive measures instituted as medically indicated.
Slovenian: Hematološki status je treba pozorno spremljati in vzpostaviti učinkovite podporne ukrepe, kadar so prisotne zdravstvene indikacije.
English: Engraftment: Engraftment has been achieved (92%-100%) in all reported conditioning treatments and it was considered to occur at the expected time.
Slovenian: 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.
English: Each infusion will last 2-4 hours.
Slovenian: Vsako infundiranje traja 2 do 4 ure.
English: 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.
Slovenian: 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.
English: This enables the transplantation of new bone marrow cells (haematopoietic progenitor cells), which in turn enable the body to produce healthy blood cells.
Slovenian: To omogoči presaditev novih celic kostnega mozga (krvotvornih matičnih celic), ki v telesu omogočijo nastajanje zdravih krvnih celic.
English: The safety of thiotepa has been examined through a review of adverse events reported in published data from clinical trials.
Slovenian: Varnost tiotepe je bila preverjena s pregledom neželenih učinkov, o katerih so poročali v objavljenih podatkih iz kliničnih študij.
English: The elimination half-life varied from 1.5 to 4.1 hours.
Slovenian: Razpolovna doba eliminacije je bila od 1,5 do 4,1 ure.
English: PRESENTATION
Slovenian: PREDSTAVITEV
English: It is not known whether this medicinal product is excreted in breast milk.
Slovenian: Ni znano, ali se to zdravilo izloča v materino mleko.
English: Due to the increase of thrombotic risk in case of malignancy, the use of anticoagulative treatment is frequent.
Slovenian: Zaradi povečanega tveganja za trombozo v primeru malignosti je antikoagulacijsko zdravljenje pogosto.
English: 20867 Caponago (MB) Italy
Slovenian: 20867 Caponago (MB) Italija
English: In order to prevent and manage infections, you will be given anti-infectives.
Slovenian: Za preprečevanje in obvladovanje okužb boste dobili zdravila proti okužbam.
English: 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.
Slovenian: 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 %).