FrancophonIA/ELRC3.0 huggingface dataset:
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).
Maltese: Għalhekk, REYATAZ ma' ritonavir huwa kontra-indikat ma' prodotti mediċinali li huma sottosratti ta' CYP3A4 u għandhom indiċi terapewtiku limitat: quetiapine, lurasidone, alfuzosin, astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, triazolam, midazolam mogħti mill-ħalq, u alkalojdi ergot, partikolarment ergotamine u dihydroergotamine (ara sezzjoni 4.3).
English: Co-administration of nevirapine with REYATAZ/ritonavir is not recommended (see section 4.4)
Maltese: REYATAZ/ritonavir mhuwiex rakkomandat (ara sezzjoni 4.4)
English: Patients with moderate to severe hepatic insufficiency (see sections 4.2 and 4.4).
Maltese: Pazjenti b'insuffiċjenza tal-fwied moderata sa severa (ara sezzjonijiet 4.2 u 4.4).
English: Co-administration of REYATAZ/ritonavir and indinavir is not recommended (see section 4.4).
Maltese: REYATAZ/ritonavir mhuwiex rakkomandat (ara sezzjoni 4.4).
English: CD4 Mean Change from Baseline, cells/mm by Baseline Characteristic
Maltese: Bidla Medja fil-CD4 mill-Linja Bażi, ċelluli/mm skont il-Karatteristiċi tal-Linja Bażi
English: Buprenorphine, once daily, stable maintenance dose (atazanavir 300 mg once daily with ritonavir 100 mg once daily)
Maltese: Buprenorphine, darba kuljum, doża ta' manteniment stabbli (atazanavir 300 mg darba kuljum ma' ritonavir 100 mg darba kuljum)
English: 100 mgd a The same recommendations regarding the timing and maximum doses of concomitant proton pump inhibitors and H2receptor antagonists in adults also apply to paediatric patients (see section 4.5).
Maltese: 100 mgd a L-istess rakkomandazzjonijiet dwar l-iskedar u d-dożi massimi tal-inibituri ta' proton pump konkomitanti u l-antagonisti tar-riċettur H2 fl-adulti japplikaw għall-pazjenti pedjatriċi (ara sezzjoni 4.5).
English: Atazanavir Cmax ↔5% (↓17% ↑8.4%)* Atazanavir Cmin ↔1.3% (↓10% ↑15)*
Maltese: Atazanavir AUC ↔2.3% (↓13% Cmax ta' Atazanavir ↔5% (↓17% Cmin ta' Atazanavir ↔1.3% (↓10%
English: Opaque blue and white capsule printed with white and blue inks, with "BMS 100 mg" on one half and with "3623" on the other half.
Maltese: Kapsula opaka blu u bajda stampata b'inka bajda u blu, b'“BMS 100 mg” fuq nofs u b'“3,623” fuq innofs l-ieħor.
English: NAME OF THE MEDICINAL PRODUCT REYATAZ 300 mg hard capsules atazanavir
Maltese: TAL-PRODOTT MEDIĊINALI REYATAZ 300 mg kapsuli ibsin atazanavir
English: 60 hard capsules: EU/1/03/267/005
Maltese: 60 kapsuli ibsin: EU/1/03/267/005
English: Co-administration with medicinal products that are substrates of the CYP3A4 isoform of cytochrome P450 and have narrow therapeutic windows (e.g., quetiapine, alfuzosin, astemizole, terfenadine, cisapride, pimozide, quinidine, lurasidone, bepridil, triazolam, midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5), and ergot alkaloids, particularly, ergotamine, dihydroergotamine, ergonovine, methylergonovine) (see section 4.5).
Maltese: L-għoti flimkien ma' prodotti mediċinali li huma sottostrati ta' isoform CYP3A4 ta' cytochrome P450 u li għandhom meded terapewtiċi dojoq (eż., quetiapine, alfuzosin, astemizole, terfenadine, cisapride, pimozide, quinidine, lurasidone, bepridil, triazolam, midazolam mogħtija mill-ħalq (għal midazolam parenterali, ara sezzjoni 4.5), u ergot alkaloids, b'mod partikolari ergotamine, dihydroergotamine, ergonovine, methylergonovine) (ara sezzjoni 4.5).
English: Among experienced patients treated with REYATAZ 300 mg once daily with 100 mg ritonavir once daily for a median duration of 95 weeks, 53% had Grade 3-4 total bilirubin elevations.
Maltese: Fost il-pazjenti li kienu rċevew il-kura, ikkurati bi REYATAZ 300 mg darba kuljum ma' 100 mg ritonavir darba kuljum għal żmien medju ta' 95 ġimgħa, 53 % kellhom żidiet totali ta' bilirubin ta' Grad 3-4.
English: Patients should be warned about these possible side effects when using PDE5 inhibitors for erectile dysfunction with REYATAZ (see section 4.4).
Maltese: Il-pazjenti għandhom jiġu mwissija dwar dawn l-effetti sekondarji li jista' jkun hemm meta jintużaw inibituri PDE5 għal disfunzjoni erettili b'REYATAZ (ara sezzjoni 4.4).
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).
Maltese: Għalhekk, REYATAZ huwa kontra-indikat ma' prodotti mediċinali li huma substrati ta' CYP3A4 u li għandhom indiċi terapewtiku limitat: quetiapine, lurasidone, alfuzosin, astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, triazolam, midazolam mogħti mill-ħalq, u alkalojdi ergot, partikolarment ergotamine u dihydroergotamine (ara sezzjoni 4.3).
English: If the combination is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of REYATAZ to 400 mg with 100 mg of ritonavir; doses of proton pump inhibitors comparable to omeprazole 20 mg should not be exceeded (see section 4.4).
Maltese: 400 mg ma' 100 mg ta' ritonavir; dożi ta' inibituri talproton pump komparabbli ma' omeprazole 20 mg m'għandhomx jinqabżu (ara sezzjoni 4.4).
English: HIV RNA Mean Change from Baseline, log10 copies/ml All patients
Maltese: Bidla Medja fl-HIV RNA mil-Linja Bażi, log10 kopji/ml Il-pazjenti kollha
English: At Week 48 there were 134 paediatric patients aged 3 months to less than 11 years that received REYATAZ oral powder with ritonavir that were evaluated for efficacy.
Maltese: Fil-Ġimgħa 48 kien hemm 134 pazjent pejatriku li kellhom bejn 3 xhur u inqas minn 11-il sena li rċevew REYATAZ trab orali ma' ritonavir li kienu evalwati għall-effikaċja.
English: PDE5 inhibitors used for the treatment of erectile dysfunction: particular caution should be used when prescribing PDE5-inhibitors (sildenafil, tadalafil, or vardenafil) for the treatment of erectile dysfunction in patients receiving REYATAZ with concomitant low-dose ritonavir.
Maltese: Inibituri PDE5 użati għall-kura ta' disfunzjoni erettili: għandha tingħata attenzjoni partikolari meta jingħataw inibituri-PDE5 (sildenafil, tadalafil, jew vardenafil) b'riċetta ta' tabib għall-kura ta' disfunzjoni erettili f'pazjenti li jirċievu REYATAZ ma' ritonavir f'doża baxxa konkomitanti.
English: Two percent of patients treated with REYATAZ experienced concurrent Grade 3-4 ALT/AST and Grade 3-4 total bilirubin elevations.
Maltese: Tnejn fil-mija tal-pazjenti taħt il-kura b'REYATAZ kellhom fl-istess ħin ALT/AST Grad 3-4 u bilirubin totali ta' Grad 3-4 elevati.
English: REYATAZ capsules may be used by adults and children 6 years of age and older.
Maltese: Il-kapsuli REYATAZ jistgħu jintużaw minn adulti u tfal li mhumiex iżgħar minn 6 snin.
English: PHARMACOLOGICAL PROPERTIES
Maltese: Parametru Farmakokinetiku
English: Famotidine 20 mg twice daily Atazanavir AUC ↓18% (↓25% ↑1%) Atazanavir Cmax ↓20% (↓32% ↓7%)
Maltese: AUC ta' Atazanavir ↓18 % (↓25 % Cmax ta' Atazanavir ↓20% (↓32% ↓7%) Cmin ta' Atazanavir ↔1% (↓16%
English: NAME OF THE MARKETING AUTHORISATION HOLDER BRISTOL-MYERS SQUIBB PHARMA EEIG
Maltese: TAD-DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ BRISTOL-MYERS SQUIBB PHARMA EEIG
English: REYATAZ should not be used in combination with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index.
Maltese: REYATAZ m'għandux jintuża f'kombinazzjoni ma' prodotti mediċinali li huma substrati ta' CYP3A4 u li għandhom indiċi terapewtiku dejjaq.
English: If a higher dose of an H2-receptor antagonist is required (eg, famotidine 40 mg twice daily or equivalent) an increase of the REYATAZ/ritonavir dose from 300/100 mg to 400/100 mg can be considered.
Maltese: Jekk tkun meħtieġa doża ogħla ta' antagonista ta' riċettur ta' H2 (eż. famotidine 40 mg darbtejn kuljum jew ekwivalenti), tista' tiġi kkunsidrata żieda fid-doża ta' REYATAZ/ritonavir minn 300/100 mg għal 400/100 mg.
English: Co-administration of voriconazole and REYATAZ with ritonavir is not recommended unless an assessment of the benefit/risk to the patient justifies the use of voriconazole (see section 4.4).
Maltese: REYATAZ/ritonavir ma' ritonavir mhuwiex rakkomandat sakemm valutazzjoni talbenefiċċju/riskju għall-pazjent ma tiġġustifikax l-użu ta' voriconazole (ara sezzjoni 4.4).
English: Interactions with other medicinal products The combination of REYATAZ with atorvastatin is not recommended (see section 4.5).
Maltese: Prodotti mediċinali li ma jaqblux ma' din il-mediċina Il-kombinazzjoni ta' REYATAZ ma' atorvastatin mhijiex rakkomandata (ara sezzjoni 4.5).
English: Opaque red and blue capsule printed with white ink, with "BMS 300 mg" on one half and with "3622" on the other half.
Maltese: Kapsula opaka blu u bajda stampata b'inka bajda u blu, b'“BMS 300 mg” fuq nofs u b'“3,622” fuq innofs l-ieħor.
English: The most frequently reported laboratory abnormality in paediatric patients receiving REYATAZ was elevation of total bilirubin (≥ 2.6 times ULN, Grade 3-4) which occurred in 45% of patients.
Maltese: L-aktar anormalità fil-laboratorju frekwenti rrappurtata f'pazjenti pedjatriċi li kienu qed jirċievu REYATAZ kienet livelli ogħla ta' bilirubina totali (≥2.6 darbiet aktar mil-livelli normali ta' fuq (ULN), Grad 3-4) li seħħet f'45 % tal-pazjenti.
English: Efficacy data observed in the 41 paediatric patients aged 6 years to less than 18 years that received REYATAZ capsules with ritonavir are presented in Table 7.
Maltese: Dejta dwar effikaċja osservata fil-41 pazjent pedjatriku li kellhom minn 6 snin sa mhux aktar minn 18il sena li ħadu l-kapsuli ta' REYATAZ hi ppreżentata f'Tabella 7.
English: For patients not taking tenofovir, if REYATAZ 300 mg/ritonavir 100 mg and H2-receptor antagonists are coadministered, a dose equivalent to famotidine 20 mg twice daily should not be exceeded.
Maltese: Għal pazjenti li mhux qed jieħdu tenofovir, jekk REYATAZ 300 mg/ritonavir 100 mg u antagonisti ta' riċettur H2 jingħataw flimkien, m'għandhiex tinqabeż doża ekwivalenti għal famotidine 20 mg darbtejn kuljum.
English: The compound selectively inhibits the virus-specific processing of viral Gag-Pol proteins in HIV-1 infected cells, thus preventing formation of mature virions and infection of other cells.
Maltese: Is-sustanza tinibixxi b'mod selettiv ilproċessar speċifiku għall-virus tal-proteini virali Gag-Pol fiċ-ċelluli infettati bl-HIV-1, b'hekk ifixkel il-formazzjoni ta' virjoli maturi u l-infezzjoni ta' ċelluli oħra.
English: When REYATAZ and ritonavir are co-administered, the metabolic drug interaction profile for ritonavir may predominate because ritonavir is a more potent CYP3A4 inhibitor than atazanavir.
Maltese: Meta REYATAZ u ritonavir jingħataw flimkien, il-profil metaboliku ta' interazzjoni ta' ritonavir jista' jippredomina għax ritonavir huwa inibitur ta' CYP3A4 iktar qawwi minn atazanavir.
English: Co-administration of efavirenz with REYATAZ/ritonavir is not recommended (see section 4.4)
Maltese: L-għoti fl-istess ħin ta' efavirenz u REYATAZ/ritonavir mhuwiex rakkomandat (ara sezzjoni 4.4)
English: Co-administration of REYATAZ with nevirapine or efavirenz is not recommended (see section 4.5).
Maltese: L-għoti fl-istess ħin ta' REYATAZ ma' nevirapine jew efavirenz mhuwiex rakkomandat (ara sezzjoni 4.5).
English: 60 hard capsules: EU/1/03/267/004
Maltese: 60 kapsuli ibsin: EU/1/03/267/004
English: 60 hard capsules: EU/1/03/267/006
Maltese: 60 kapsuli ibsin: EU/1/03/267/006
English: Race: a population pharmacokinetic analysis of samples from Phase II clinical trials indicated no effect of race on the pharmacokinetics of atazanavir.
Maltese: Razza: skond l-analiżi farmakokinetika fuq popolazzjoni minn kampjuni ta' provi kliniċi ta' Fażi
English: The pharmacokinetics of atazanavir exhibit a non-linear disposition.
Maltese: Il-farmakokinetiċi ta' atazanavir juru dispożizzjoni mhux lineari.
English: What REYATAZ looks like and contents of the pack Each capsule of REYATAZ 200 mg contains 200 mg atazanavir.
Maltese: Kull kapsula ta' REYATAZ 200 mg fiha 200 mg atazanavir.
English: Body weight (kg)
Maltese: Piż tal-Ġisem (kg)
English: Nephrolithiasis has been reported in patients receiving REYATAZ (see section 4.8).
Maltese: Nefrolitjażi ġiet irrapportata f'pazjenti li kienu qed jirċievu REYATAZ (ara sezzjoni 4.8).
English: Polyester film/Aluminum/Polyethylene sealant film sachet.
Maltese: Hemm bżonn ta' aktar monitoraġġ kliniku u fil-laboratorju għat-trażżin talHIV.
English: 60 hard capsules: EU/1/03/267/002
Maltese: 60 kapsuli ibsin: EU/1/03/267/002
English: The risk of a further decrease in atazanavir exposure is expected when atazanavir is given with medicinal products known to reduce its exposure (e.g., tenofovir disoproxil or H2-receptor antagonists).
Maltese: Ir-riskju ta' aktar tnaqqis fl-espożizzjoni ta' atazanavir huwa mistenni meta atazanavir jingħata ma' prodotti mediċinali magħrufin li jnaqqsu l-espożizzjoni tiegħu (eż. tenofovir disoproxil fumarate jew antagonisti tar-riċettur ta' H2).
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Maltese: Id-data ta' meta tiskadi tirreferi għall-aħħar ġurnata ta' dak ix-xahar.
English: Ritonavir is administered immediately following REYATAZ powder administration.
Maltese: Tfal li jirċievu REYATAZ jista' jkollhom bżonn li qalbhom tiġi mmonitorjata.
English: 60 hard capsules: EU/1/03/267/001
Maltese: 60 kapsuli ibsin: EU/1/03/267/001
English: For patients who are taking tenofovir disoproxil fumarate, if REYATAZ/ritonavir with both tenofovir disoproxil and an H2-receptor antagonist are coadministered,a dose increase of REYATAZ to 400 mg with 100 mg of ritonavir is recommended.
Maltese: REYATAZ/ritonavir kemm ma' tenofovir disoproxil kif ukoll ma' antagonist ta' riċettur H2 jingħataw flimkien, hija rakkomandata żieda fid-doża ta' REYATAZ għal 400 mg ma' 100 mg ta' ritonavir.
English: What REYATAZ looks like and contents of the pack Each capsule of REYATAZ 100 mg contains 100 mg atazanavir.
Maltese: Kull kapsula ta' REYATAZ 100 mg fiha 100 mg atazanavir.
English: 60 hard capsules: EU/1/03/267/003
Maltese: 60 kapsuli ibsin: EU/1/03/267/003
English: How to take REYATAZ 4.
Maltese: Kif għandek tieħu REYATAZ 4.
English: Co-administration of REYATAZ/ritonavir with alfuzosin is contraindicated (see section 4.3)
Maltese: L-għoti fl-istess ħin ta' REYATAZ/ritonavir ma' alfuzosin huwa kontra-indikat (ara sezzjoni 4.3)
English: REYATAZ/ritonavir may increase plasma levels of carbamazepine due to CYP3A4 inhibition.
Maltese: REYATAZ/ritonavir jista' jżid il-livelli ta' carbamazepine fil-plasma minħabba inibizzjoni ta' CYP3A4.
English: Co-administration of REYATAZ with other hormonal contraceptives or oral contraceptives containing progestogens other than norgestimate or norethindrone has not been studied, and therefore should be avoided (see section 4.5).
Maltese: L-għoti flimkien ta' REYATAZ ma' kontraċettivi ormonali oħrajn li jkun fihom progestogens, ħlief norgestimate jew norethindrone ma ġiex studjat, u għalhekk għandu jiġi evitat (ara sezzjoni 4.5).
English: Atazanavir, dosed 1 hr after ddI+d4T (fasted)
Maltese: Atazanavir (pm): kollha mogħtija malikel
English: HIV RNA <50 copies/ml by select baseline PI substitutions,c % (responder/evaluabled) NA
Maltese: HIV RNA <50 kopja/ml, % Il-pazjenti kollhad Stima tad-differenza [95% CI]d
English: PHARMACEUTICAL FORM AND CONTENTS Oral Powder
Maltese: U KONTENUT Trab Orali
English: Co-administration of lurasidone with REYATAZ is contrandicated as this may increase lurasidone-related toxicity (see section 4.3).
Maltese: Hemm riskju ta' telf taleffett terapewtiku u ta' żvilupp ta' reżistenza (ara sezzjoni 4.3).
English: e Number of patients evaluable.
Maltese: e Numru ta' pazjenti evalwabbli.
English: grazoprevir-containing products, including elbasvir/grazoprevir fixed dose combination, and glecaprevir/pibrentasvir fixed dose combination (used to treat chronic hepatitis C infection)
Maltese: triazolam u midazolam orali (tittieħed mill-ħalq) (użat biex igħin wieħed jorqod/itaffi lansjetà) simvastatin u lovastatin (biex ibaxxu l-kolesterol fid-demm). prodotti li fihom grazoprevir, inkluż doża fissa kombinata ta' elbasvir/grazoprevir, u doża fissa kombinata ta' glecaprevir/pibrentasvir (jintużaw biex jikkura infezzjoni tal-epatite C kronika)
English: When compared to atazanavir 300 mg with ritonavir 100 mg without tenofovir, atazanavir concentrations are expected to be additionally decreased by about 20%.
Maltese: Meta mqabbel ma' atazanavir 300 mg ma' ritonavir 100 mg mingħajr tenofovir, il-konċentrazzjonijiet ta' atazanavir huma mistennija li jonqsu b'mod addizzjonali b'madwar 20 %.
English: Orange vanilla flavour
Maltese: F'dan il-fuljett
English: None of the de novo substitutions (see Table 4) are specific to atazanavir and may reflect reemergence of archived resistance on atazanavir + ritonavir in Study 045 treatment-experienced population.
Maltese: L-ebda sostituzzjoni de novo (ara Tabella 4) ma hi speċifika għal atazanavir u għandha mnejn tirrifletti l-ħruġ mill-ġdid ta' reżistenza arkivjata fuq atazanavir + ritonavir fi Studju 045 ta' popolazzjoni li għaddiet minn kura.
English: If you develop a rash inform your doctor immediately.
Maltese: Ara l-fuljett għal aktar informazzjoni.
English: Accord Healthcare Polska Sp. z o.o.
Maltese: Accord Healthcare Polska Sp. z o.o. Teл.:
English: Acute graft versus host disease Chronic graft versus host disease
Maltese: Graft versus host disease akuta Graft versus host disease kronika
English: The duration of treatment can last up to 5 days.
Maltese: It-tul tat-trattament jista' jdum sa 5 ijiem.
English: Date of first authorisation: 15 March 2010 Date of latest renewal: 15 March 2015
Maltese: Data tal-aħħar tiġdid: 15 ta' Marzu, 2015
English: - The active substance is thiotepa.
Maltese: - Is-sustanza attiva hi thiotepa.
English: RIEMSER Pharma GmbH Bahnhofstraße 44b 17489 Greifswald Germany
Maltese: RIEMSER Pharma GmbH Bahnhofstraße 44b 17489 Greifswald
English: PC: {number}] SN: {number} NN: {number} [
Maltese: {numru} NN: {numru}
English: Solid tumours
Maltese: Tumuri solidi
English: Accord Healthcare S.L.U.
Maltese: Accord Healthcare S.
English: The total clearance of thiotepa ranged from 11.4 to 23.2 l/h/m2.
Maltese: It-tneħħija totali ta' thiotepa kienet tvarja minn 11.4 sa 23.2 l/h/m2.
English: The action of succinyl-choline can be prolonged by 5 to 15 minutes.
Maltese: L-azzjoni ta' succinyl-choline tista' tiġi mtawwla b'5 minuti sa 15-il minuta.
English: GvHD (graft versus host disease): all conditioning treatments evaluated assured a low incidence of acute GvHD grade III-IV (from 4% to 24%).
Maltese: GvHD (graft versus host disease): il-kuri kollha ta' kondizzjonament evalwati żguraw inċidenza baxxa ta' GvHD akuta ta' grad III-IV (minn 4% sa 24%).
English: SICKLE CELL ANAEMIA
Maltese: ANEMIJA SICKLE CELL
English: 20867 Caponago (MB) Italy
Maltese: 20867 Caponago (MB) L-Italja
English: Alkylating chemotherapeutic agents, including thiotepa, inhibit plasma pseudocholinesterase by 35% to 70%.
Maltese: Sustanzi kemoterapewtiċi alkilanti, inkluż thiotepa, jinibixxu l-pseudocholinesterase fil-plażma b'35% sa 70%.
English: CNS TUMOURS
Maltese: TUMURI CNS
English: The elimination half-life varied from 1.5 to 4.1 hours.
Maltese: Il-half-life ta' eliminazzjoni kienet tvarja minn 1.5 sa 4.1 sigħat.
English: In some cases, relapse rates of 35% and of 45% have been reported at 5 years and 6 years respectively.
Maltese: F'ċerti każi, ġew irrappurtati rati ta' rikaduta ta' 35% u ta' 45% wara 5 snin u 6 snin rispettivament.
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.
Maltese: Il-frazzjoni li ma tintrabatx mal-proteini fil-plażma hija ta' 70-90%; ġie rrappurtat irbit insinifikanti ta' thiotepa mal-gamma globulin u rbit minimu mal albumin (10-30%).
English: 20867 Caponago (MB) Italy adienne@adienne.com
Maltese: 20867 Caponago (MB) L-Italja adienne@adienne.com
English: Thiotepa appears to be metabolised via CYP2B6 and CYP3A4.
Maltese: Thiotepa jidher li huwa metabolizzat permezz ta' CYP2B6 u CYP3A4.
English: PC: {number} SN: {number} NN: {number}
Maltese: {numru} SN:
English: 20867 Caponago (MB) Italy Tel: +39-02 40700445 adienne@adienne.com
Maltese: 20867 Caponago (MB) L-Italja Tel.+39-02 40700445 adienne@adienne.com
English: Agency http://www.ema.europa.eu.
Maltese: Ewropea għall-Mediċini http://www.ema.europa.eu
English: Each infusion will last 2-4 hours.
Maltese: Kull infużjoni ddum 2-4 sigħat.
English: Menopausal symptoms Infertility female Infertility male
Maltese: Infertilità femminili Infertilità maskili
English: Overall Survival (OS): OS ranged from 17% to 84% with a follow-up ranging from 12.3 up to 99.6 months.
Maltese: Sopravvivenza globali (OS): l-OS kien ivarja minn 17% sa 84% b'segwitu li jvarja minn 12.3 sa 99.6 xhur.
English: Delirium Nervousness Hallucination Agitation
Maltese: Nervożità Alluċinazzjoni Aġitazzjoni
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.
Maltese: L-aktar reazzjonijiet avversi komuni rrapportati fil-kuri differenti ta' kondizzjonament inkluż thiotepa huma: infezzjonijiet, ċitopenja, GvHD akuta u GvHD kronika, disturbi gastro-intestinali, ċistite emorraġika, infjammazzjoni mukożali.
English: Pharmacotherapeutic group: Antineoplastic agents, Alkylating Agents, ATC code: L01AC01
Maltese: Aġenti antineoplastiċi, Aġenti Alkylating,, Kodiċi ATC:
English: Overall Survival: OS ranged from 30% to 87% with a follow-up ranging from 11.7 up to 87 months.
Maltese: Sopravvivenza Globali: l-OS kien ivarja minn 30% sa 87% b'segwitu li jvarja minn 11.7 sa 87 xahar.
English: Thiotepa is a polyfunctional cytotoxic agent related chemically and pharmacologically to the nitrogen mustard.
Maltese: Thiotepa huwa sustanza ċitotossika polifunzjonali relatata kimikament u farmakoloġikament malmustarda tan-nitroġenu.
English: Overall Survival (OS): OS ranged from 50% to 100% with a follow-up ranging from 9.4 up to 121 months.
Maltese: Sopravvivenza globali (OS): l-OS kien ivarja minn 50% sa 100% b'segwitu li jvarja minn 9.4 sa 121 xahar.
English: MULTIPLE MYELOMA
Maltese: MAJELOMA MULTIPLA
English: Cardiomyopathy Myocarditis
Maltese: Insuffiċjenza kardijaka kardjomijopatija Mijokardite
English: Severe toxic skin reactions including cases of StevensJohnson syndrome and toxic epidermal necrolysis
Maltese: Reazzjonijiet tossiċi severi talġilda li jinkludu każijiet tas sindrome ta' Stevens-Johnson u nekrolisi epidermali tossika
English: Thiotepa undergoes oxidative desulphuration via the cytochrome P450 CYP2B and CYP3A isoenzyme families to the major and active metabolite TEPA (triethylenephosphoramide).
Maltese: Thiotepa jgħaddi minn desulfurazzjoni ossidattiva permezz tal-familji iżoenżimi taċ-ċitokroma P450 CYP2B u CYP3A għall-akbar u l-aktar metabolit attiv TEPA (triethylenephosphoramide).
English: Live attenuated vaccines (except yellow fever): risk of systemic, possibly fatal disease.
Maltese: Vaċċini ħajjin attenwati (minbarra d-deni l-isfar): riskju ta' mard sistematiku, possibbilment fatali.
English: Frequencies are defined as: very common (≥1/10), common ((≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma definiti bħala: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).