FrancophonIA/ELRC3.0 huggingface dataset:
English: N-acetyl-gamma-calicheamicin dimethylhydrazide (the cytotoxic agent released from inotuzumab ozogamicin) was mutagenic in an in vitro bacterial reverse mutation (Ames) assay.
Maltese: N-acetyl-gammacalicheamicin dimethylhydrazide (l-aġent ċitotossiku li jiġi rilaxxat minn inotuzumab ozogamicin) kien mutaġeniku f'assaġġ ta' mutazzjoni bil-maqlub (reverse) ta' batterji in vitro (Ames).
English: Hepatic impairment
Maltese: Mediċini oħra u BESPONSA
English: No data are available.
Maltese: L-ebda dejta mhux disponibbli.
English: Infusion related reaction (10%)
Maltese: Infezzjonijiet u infestazzjonijiet Infezzjoni (48%)
English: Your doctor will take an electrocardiogram (ECG) and blood tests to measure electrolytes (e.g., calcium, magnesium, potassium) before the first dose of BESPONSA and repeat these tests during treatment.
Maltese: It-tabib tiegħek ser jieħu elettrokardjogramma (ECG) u testijiet taddemm biex ikejjel elettroliti (eż, kalċju, manjesju, potassju) qabel l-ewwel doża ta' BESPONSA u jirrepeti dawn it-testijiet waqt it-trattament.
English: Patients should be monitored closely during and for at least 1 hour after the end of infusion for the potential onset of infusion related reactions, including symptoms such as hypotension, hot flush, or breathing problems.
Maltese: Pazjenti għandhom ikunu mmonitorjati mill-qrib waqt u għal mill-inqas siegħa wara t-tmiem talinfużjoni għall-bidu potenzjali ta' reazzjonijiet relatati mal-infużjoni, inklużi sintomi bħal ipotensjoni, fwawar ta' sħana, jew problemi fin-nifs.
English: Median DoRg; months [95% CI]
Maltese: OS medjana; xhur [95% CI]
English: In repeat dose toxicity studies in rats and monkeys, female reproductive findings included atrophy of ovaries, uterus, vagina, and mammary gland.
Maltese: Fi studji dwar effett tossiku minn dożi ripetuti fil-firien u x-xadini is-sejbiet riproduttivi ta' dawk femminili kienu jinkludu atrofija talovarju, l-utru, il-vaġina u l-glandola mammarja.
English: • Fatigue
Maltese: • Stitikezza
English: VOD/SOS was also reported in 18 patients after a subsequent HSCT.
Maltese: Il-VOD/SOS kienu wkoll irrappurtat fi 18-il pazjent wara HSCT sussegwenti.
English: • tumour lysis syndrome (see section 2); this may be associated with a variety of symptoms in the stomach and intestines (for example, nausea, vomiting, diarrhoea), heart (for example, changes in the rhythm), kidney (for example, decreased urine, blood in urine), and nerves and muscles (for example, muscular spasms, weakness, cramps).
Maltese: • sindrome magħruf bħala sindrome ta' lisi tat-tumur (ara sezzjoni 2); li jista' jiġi assoċjat ma' varjeta ta' sintomi fl-istonku u fl-imsaren (pereżempju dardir, rimettar, dijarea), fil-qalb (pereżempju, bidliet fir-ritmu), fil-kliewi (pereżempju, tnaqqis fl-awrina, demm fl-awrina), u fin-nervituri u fil-muskoli (pereżempju, spażmi muskolari, dgħufija, bugħawwieġ).
English: Management of severe infection, bleeding/haemorrhage and other effects of myelosuppression, including severe neutropenia or thrombocytopenia, may require a dosing interruption, dose reduction, or discontinuation of treatment (see section 4.2).
Maltese: Il-ġestjoni ta' infezzjoni severa, fsada/emorraġija u effetti oħra ta' majelosoppressjoni, inkluż newtropenija jew tromboċitopenija severi, tista' tkun teħtieġ interruzzjoni tad-dożaġġ, tnaqqis fiddoża, jew twaqqif tal-kura (ara sezzjoni 4.2).
English: a, b, c, d, e, f For definition, see Table 6 (with the exception that CR/CRi was not per EAC for Study 2)
Maltese: Għad-definizzjoni, ara t-Tabella 6 (bl-eċċezzjoni li CR/CRi ma kienx għal kull EAC għall-Istudju 2)
English: • infusion related reaction (see section 2); signs and symptoms include fever and chills or breathing problems during or shortly after the BESPONSA infusion.
Maltese: • reazzjoni relatata mal-infużjoni (ara sezzjoni 2); sinjali u sintomi jinkludu deni u tertir ta' bard waqt jew ftit wara l-infużjoni ta' BESPONSA.
English: Patients should be observed during, and for at least 1 hour after the end of infusion for symptoms of infusion related reactions (see section 4.4).
Maltese: Il-pazjenti għandhom jiġu osservati waqt, u mill-inqas siegħa wara t-tmiem tal-infużjoni għal sintomi ta' reazzjonijiet relatati mal-infużjoni (ara sezzjoni 4.4).
English: Median PFSe, f; months [95% CI]
Maltese: DoR medjan f; xhur [95% CI]
English: Nonclinical data suggest that the anticancer activity of BESPONSA is due to the binding of the ADC to CD22-expressing tumour cells, followed by internalisation of the ADC-CD22 complex, and the intracellular release of N-acetyl-gamma-calicheamicin dimethylhydrazide via hydrolytic cleavage of the linker.
Maltese: It-tagħrif mhux kliniku jissuġġerixxi li l-attività kontra l-kanċer ta' BESPONSA hija minħabba l-irbit tal-ADC maċ-ċelluli tat-tumur li jesprimu s-CD22, segwit mill-internalizzazzjoni tal-kumpless ADC-CD22, u r-rilaxx intraċellulari ta' N-acetyl-gamma-calicheamicin dimethylhydrazide permezz tal-qtugħ (cleavage) idrolitiku tal-linker.
English: Patients should be monitored for increases in amylase and lipase.
Maltese: Il-pazjenti għandhom ikunu mmonitorjati għal żidiet fl-amylase u fil-lipase.
English: BESPONSA is used to treat adults with acute lymphoblastic leukaemia.
Maltese: BESPONSA jintuża biex jikkura adulti b'lewkimja limfoblastika akuta.
English: A third cycle may be considered for those patients who do not achieve a complete remission (CR) or complete remission with incomplete haematological recovery (CRi) and minimal residual disease (MRD) negativity after 2 cycles (see section 4.4).
Maltese: Jista' jitqies it-tielet ċiklu għal dawk ilpazjenti li ma jiksbux remissjoni sħiħa (CR, complete remission) jew remissjoni sħiħa b'irkupru ematoloġiku mhux komplut (Cri, incomplete haematological recovery) u negattività tar-residwu minimu tal-marda (MRD, minimal residual disease) wara 2 ċikli (ara sezzjoni 4.4).
English: For clinical management of infections, see section 4.4.
Maltese: Għall-ġestjoni klinika tal-infezzjonijiet, ara sezzjoni 4.4.
English: Among the 79 patients who proceeded to a subsequent HSCT (8 of whom received additional salvage therapy after treatment with BESPONSA before proceeding to HSCT), VOD/SOS was reported in 18 (23%) patients.
Maltese: Fost is79 pazjent li pproċedew għal HSCT sussegwenti (8 minnhom irċevew terapija ta' salvataġġ addizzjonali wara l-kura b'BESPONSA qabel ipproċedew għall-HSCT), VOD/SOS ġiet irrappurtata fi 18 (23%)-il pazjent.
English: BESPONSA 1 mg powder for concentrate for solution for infusion
Maltese: BESPONSA 1 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
English: Tumour lysis syndrome is associated with a variety of symptoms in the stomach and intestines (for example, nausea, vomiting, diarrhoea), heart (for example, changes in the rhythm), kidney (for example, decreased urine, blood in urine), and nerves and muscles (for example, muscular spasms, weakness, cramps).
Maltese: Is-sindrome ta' lisi tat-tumur huwa assoċjat ma' varjetà ta' sintomi flistonku u fl-imsaren (pereżempju dardir, rimettar, dijarea), fil-qalb (pereżempju, bidliet fir-ritmu), filkliewi (pereżempju, tnaqqis fl-awrina, demm fl-awrina), u fin-nervituri u fil-muskoli (pereżempju, spażmi muskolari, dgħufija, bugħawwieġ).
English: In patients who tested positive for anti-inotuzumab ozogamicin antibodies, no effect on clearance of BESPONSA was detected based on population-pharmacokinetic analysis.
Maltese: F'pazjenti li ttestjaw pożittivi għal antikorpi anti-inotuzumab ozogamicin, ma ġie identifikat l-ebda effett fuq it-tneħħija ta' BESPONSA abbażi tal-analiżi farmakokinetika tal-popolazzjoni.
English: In vitro, N-acetyl-gamma-calicheamicin dimethylhydrazide was primarily metabolised via nonenzymatic reduction.
Maltese: In vitro, N-acetyl-gamma-calicheamicin dimethylhydrazide ġie primarjament metabolizzati permezz tat-tnaqqis mhux enzimatiku.
English: • Bleeding
Maltese: Treddigħ
English: Dose modifications for non-haematological toxicities at any time during treatment Non-haematological toxicity Dose modification(s) VOD/SOS or other severe liver toxicity
Maltese: Modifikazzjoni(jiet) fit-tossiċità u fid-doża
English: N-acetyl-gamma-calicheamicin is covalently attached to the antibody via an acid-cleavable linker.
Maltese: N-acetyl-gamma-calicheamicin hija marbuta b'mod kovalenti mal-antikorp permezz ta' acid-cleavable linker.
English: The dose of inotuzumab ozogamicin is administered based on body surface area (see section 4.2).
Maltese: Id-doża ta' inotuzumab ozogamicin tingħata abbażi tal-erja tas-superfiċje tal-ġisem (ara sezzjoni 4.2).
English: b CRi, per EAC, was defined as < 5% blasts in the bone marrow and the absence of peripheral blood leukaemic blasts, partial recovery of peripheral blood counts (platelets < 100 × 109/L and/or ANC < 1 × 109/L) and resolution of any extramedullary disease.
Maltese: CRi, għal kull EAC, ġiet definita bħala < 5% tal-blasts fil-mudullun u n-nuqqas ta' blasts lewkemiċi taddemm periferali, irkupru mhux komplut tal-għadd tad-demm periferali (plejtlits tad-demm < 100 × 10
English: The active ingredient in BESPONSA is inotuzumab ozogamicin.
Maltese: L-ingredjent attiv f'BESPONSA huwa inotuzumab ozogamicin.
English: • The diluted solution must be used immediately, stored at room temperature (20 °C-25 °C) or in a refrigerator (2 °C-8 °C).
Maltese: • Is-soluzzjoni dilwita għandha tintuża immedjatament, tinħażen f'temperatura ambjentali (20°C-25°C) jew fi friġġ (2°C-8°C).
English: For the first cycle, the recommended total dose of BESPONSA for all patients is 1.8 mg/m2 per cycle, given as 3 divided doses on Days 1 (0.8 mg/m2), 8 (0.5 mg/m2), and 15 (0.5 mg/m2).
Maltese: Għall-ewwel ċiklu, id-doża totali rakkomandata għall-pazjenti kollha hija ta' 1.8 mg/m 2 għal kull ċiklu, mogħtija bħala 3 dożi maqsuma f'Jiem 1 (0.8 mg/m 2), 8 (0.5 mg/m 2), u 15 (0.5 mg/m 2).
English: All patients were required to have ≥ 5% bone marrow blasts and to have received 1 or 2 prior induction chemotherapy regimens for ALL.
Maltese: Il-pazjenti kollha kienu jeħtieġu li jieħdu blasts tal-mudullun ≥ 5% u li jkunu rċevew kors 1 jew 2 ta' qabel il-kimoterapija tal-induzzjoni għal ALL.
English: In the pivotal study (N=164), TLS, which may be life-threatening or fatal, was reported in 4/164 (2%) patients.
Maltese: Fl-istudju importanti ħafna (N=164), ġie rrappurtat TLS, li jista' jkun ta' periklu għall-ħajja jew fatali f'4/164 (2%) pazjent.
English: The recommended BESPONSA dose was determined to be 1.8 mg/m2/cycle administered at a dose of 0.8 mg/m2 on Day 1 and 0.5 mg/m2 on Days 8 and 15 of a 28-day cycle with a dose reduction upon achieving CR/CRi.
Maltese: Id-doża rakkomandata ta' BESPONSA ġiet determinata li hija ta' 1.8 mg/m 2/ċiklu mogħtija f'doża ta' 0.8 mg/m 2 f'Jum 1 u 0.5 mg/m 2 f'Jiem 8 u 15 taċ-ċiklu ta'
English: In patients receiving inotuzumab ozogamicin, TLS, which may be life-threatening or fatal, was reported (see section 4.8).
Maltese: F'pazjenti li qed jirċievu inotuzumab ozogamicin, ġie rrappurtat TLS, li jista' jkun ta' periklu għallħajja jew fatali (ara sezzjoni 4.8).
English: In the clinical study, the sensitivity of some local tests was lower than the central laboratory test.
Maltese: Fl-istudju kliniku, is-sensittività ta' xi testijiet lokali kien aktar baxx mit-test tal-laboratorju ċentrali.
English: BESPONSA should be administered with caution in patients who have a history of, or predisposition to QT interval prolongation, who are taking medicinal products that are known to prolong QT interval (see section 4.5) and in patients with electrolyte disturbances.
Maltese: BESPONSA għandu jingħata b'kawtela f'pazjenti li għandhom storja ta', jew predispożizzjoni għal titwil fl-intervall tal-QT, li qed jieħdu prodotti mediċinali li huma magħrufa li jtawlu l-intervall tal-QT (ara sezzjoni 4.5) u f'pazjenti b'disturbi fl-elettroliti.
English: Among patients who proceeded to HSCT after BESPONSA treatment, VOD/SOS was reported in 5/11 (46%) patients who received an HSCT both prior to and after BESPONSA treatment and 13/68 (19%) patients who only received an HSCT after BESPONSA treatment.
Maltese: Fost il-pazjenti li pproċedew għall-HSCT wara t-trattament b'BESPONSA, VOD / SOS kien irrappurtat fi 5/11 (46%) pazjent li rċevew HSCT kemm qabel kif ukoll wara t-trattament b'BESPONSA u 13/68 (19%) pazjent li rċevew biss HSCT wara trattament b'BESPONSA.
English: In addition, inotuzumab ozogamicin and N-acetyl-gamma-calicheamicin dimethylhydrazide are unlikely to alter the exposure of substrates of CYP enzymes, and N-acetyl-gamma-calicheamicin dimethylhydrazide is unlikely to alter the exposure of substrates of UGT enzymes or major drug transporters.
Maltese: Barra minn hekk inotuzumab ozogamicin u N-acetyl-gamma-calicheamicin dimethylhydrazide x'aktarx li mhux se jbiddlu l-esponiment ta' substrati tal-enzimi CYP, u N-acetyl-gamma-calicheamicin dimethylhydrazide x'aktarx li mhux se jbiddel l-esponiment ta' substrati ta' enzimi CYP jew trasportaturi tal-mediċini maġġuri.
English: Day 15a c CR is defined as < 5% blasts in the bone marrow and the absence of peripheral blood leukaemic blasts, full recovery of peripheral blood counts (platelets ≥ 100 × 109/L and ANC ≥ 1 × 109/L) and resolution of any extramedullary disease.
Maltese: CR hija definita bħala < 5% tal-blasts fil-mudullun u n-nuqqas ta' blasts lewkemiċi tad-demm periferali, irkupru sħiħ tal-għadd tad-demm periferali (plejtlits tad-demm ≥ 100 × 10
English: Febrile neutropenia, which may be life-threatening, was reported in 43 (26%) patients.
Maltese: Newtropenija bid-deni, li tista' tkun ta' periklu għall-ħajja, ġiet irrappurtata f'43 (26%) pazjent.
English: No patients had an increase in QTcF interval > 500 msec. Grade 2 QT interval prolongation was reported in 2/164 (1%) patients.
Maltese: Ġie rrappurtat titwil fl intervall tal-QT ta' Grad 2 fi 2/164 (1%) pazjent.
English: Inotuzumab ozogamicin pharmacokinetics were well characterised by a 2-compartment model with linear and time-dependent clearance components.
Maltese: Il-farmakokinetiċi ta' inotuzumab ozogamicin kienu kkaratterizzati sew minn mudell b'żewġ kompartimenti b'komponenti ta' tneħħija lineari u dipendenti fuq il-ħin.
English: Dose modification of BESPONSA may be required based on individual safety and tolerability (see section 4.4).
Maltese: Il-modifika tad-doża ta' BESPONSA tista' tkun meħtieġa fuq il-bażi tas-sigurtà u t-tollerabilità individwali (ara sezzjoni 4.4).
English: Treatment with BESPONSA may prolong QT interval (a change in electrical activity of the heart that can cause serious irregular heart rhythms).
Maltese: Il-kura b'BESPONSA jista' jtawwal l-intervall tal-QT (bidla fl-attività elettrika tal-qalb li jista' jikkawża ritmi tal-qalb irregolari).
English: In humans, the total volume of distribution of inotuzumab ozogamicin was approximately 12 L.
Maltese: Fil-bnedmin, il-volum totali tad-distribuzzjoni ta' inotuzumab ozogamicin kien madwar 12 L.
English: b Pancytopenia includes the following reported preferred terms: Bone marrow failure, Febrile bone marrow aplasia, and Pancytopenia.
Maltese: Insuffiċjenza tal-mudullun, Aplasija talmudullun febrili, u Panċitopenija.
English: Name and address of the manufacturer(s) of the biological active substance(s)
Maltese: Isem u indirizz tal-manifattur(i) tas-sustanza(i) bijoloġika(ċ)i attiva/i
English: Management of some adverse drug reactions may require dosing interruptions and/or dose reductions, or permanent discontinuation of BESPONSA (see sections 4.4 and 4.8).
Maltese: Il-ġestjoni ta' xi reazzjonijiet avversi tal-mediċina tista' tkun teħtieġ interruzzjonijiet fid-dożaġġ u/jew tnaqqis fid-doża, jew twaqqif permanenti ta' BESPONSA (ara ssezzjonijiet 4.4 u 4.8).
English: Alternatively, CD22 expression was assessed using immunohistochemistry in patients with an inadequate bone marrow aspirate and insufficient circulating blasts.
Maltese: Inkella, l-espressjoni tas-CD22 ġiet ivvalutata bl-użu ta' immunoistokimika f'pazjenti b'aspirat tal-mudullun mhux adegwat u bi blasts li jiċċirkolaw mhux suffiċjenti.
English: Renal impairment
Maltese: Reazzjoni relatata mal-infużjoni
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali urew effetti tossiċi fuq is-sistema riproduttiva (ara 5.3).
English: Grade ≥ 2a non-haematological toxicity (BESPONSA-related)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: BESPONSA should not be administered as an intravenous push or bolus.
Maltese: Tagħtix BESPONSA bħala injezzjoni push jew bolus ġol-vini.
English: Pregnancy
Maltese: Tilqim
English: No patients tested positive for neutralising anti-inotuzumab ozogamicin antibodies.
Maltese: L-ebda pazjent ma ttestja pożittiv għal antikorpi anti-inotuzumab ozogamicin newtralizzanti.
English: CRa/CRib; n (%) [95% CI] CRa; n (%) [95% CI] CRib; n (%) [95% CI] Median DoRf; months [95% CI]
Maltese: rata d (%) [95% CI] PFS medjana e; xhur [95% CI]
English: If severe VOD/SOS occurs, the patient should be treated according to standard medical practice.
Maltese: Jekk iseħħu VOD/SOS severi, il-pazjent għandu jkun ikkurat skont il-prattika medika standard.
English: If a 25% decrease in the total dose followed by a decrease to 2 doses per cycle is not tolerated, then permanently discontinue treatment.
Maltese: Jekk ma jiġix ittollerat ittnaqqis ta' 25% fid-doża totali segwit minn tnaqqis ta' 2 dożi għal kull ċiklu, waqqaf il-kura b'mod permanenti.
English: Possible side effects 5.
Maltese: Effetti sekondarji possibbli 5.
English: Dublin 15, D15 T867
Maltese: D15 T867
English: The absolute bioavailability is 86±18%.
Maltese: Il-bijodisponibilità assoluta hija ta' 86±18%.
English: Instructions for preparation, see section 6.6.
Maltese: Struzzjonijiet għall-preparazzjoni, ara sezzjoni 6.6.
English: LIST OF EXCIPIENTS Sucrose and preservatives (E218 and E216)
Maltese: TA' EĊĊIPJENTI Sucrose u preservattivi (E218 u E216)
English: Date of last renewal: 20 April 2011
Maltese: Data tal-aħħar tiġdid: 20 ta' April 2011
English: Patient weight 26-50 ml/min
Maltese: Piż tal-pazjent 26-50 ml/min
English: uncommon: arthralgia, myalgia
Maltese: mhux komuni: artralġja, mijalġja
English: ≤ 25 ml/min (including dialysis dependence*)
Maltese: ≤ 25 ml/min (tinkludi dawk dipendenti fuq id dijaliżi*)
English: Store below 25°C (aclar/alu blisters).
Maltese: Aħżen f'temperatura taħt 25°C (folji aclar/alu).
English: The mother-infant pairs were randomised to receive either stavudine (N= 91), didanosine (N= 94), stavudine + didanosine (N= 88) or zidovudine (N= 89).
Maltese: Il-pari omm-tarbija ġew magħżulin b'mod każwali biex jirċievu jew stavudine (N= 91), didanosine (N= 94), stavudine+didanosine (N= 88) jew zidovudine (N= 89).
English: Methylhydroxybenzoate (E218) Propylhydroxybenzoate (E216) Silicon dioxide
Maltese: Togħma taċ-ċirasa Methylhydroxybenzoate (E218) Propylhydroxybenzoate (E216) Silicon dioxide
English: Table 1: Efficacy Outcomes at Week 48 (Studies AI455-099 and AI455-096)
Maltese: Tabella 1: Riżultati tal-Effikaċja f'Ġimgħa 48 (Studji AI455-099 u AI455-096)
English: Lactose intolerance: the hard capsule contains lactose.
Maltese: Intolleranza għal-lactose: il-kapsula iebsa fiha lactose.
English: Zerit contains lactose
Maltese: TA' EĊĊIPJENTI Lactose
English: 95% Confidence intervals for the mother-to-child-transmission rates were 5.4-19.3% (stavudine), 5.2-18.7% (didanosine); 1.3-11.2% (stavudine + didanosine); and 1.9-12.6% for zidovudine.
Maltese: Intervalli tal-kunfidenza ta' 95% għar-rata ta' trasmissjoni tal-marda mill-omm għat-tarbija kienu ta' 5.4-19.3% (stavudine), 5.2-18.7% (didanosine); 1.3-11.2% (stavudine+didanosine); u 1.9-12.6% għal zidovudine.
English: PHARMACEUTICAL FORM AND CONTENTS 56 hard capsules
Maltese: FARMAĊEWTIKA U KONTENUT 56 kapsula iebsa
English: The ingredients of the capsule shell are gelatine, iron oxide colorant (E172), silicon dioxide, sodium laurilsulphate and titanium dioxide colorant (E171).
Maltese: Il-parti ta' barra tal-kapsula fiha ġelatina, kulur iron oxide (E172), silicon dioxide, sodium laurilsulphate u kulur titanium dioxide (E171).
English: The results of AI455-099 and AI455-096 are presented in Table 1.
Maltese: Ir-riżultati ta' AI455-099 u AI455-096 huma mniżżla f'Tabella 1.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 08 May 1996
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 8 ta' Mejju 1996
English: Blanchardstown Corporate Park 2 Dublin 15, D15 T867
Maltese: Blanchardstown Corporate Park 2 Dublin 15
English: PHARMACEUTICAL FORM AND CONTENTS 60 hard capsules
Maltese: FARMAĊEWTIKA U KONTENUT 60 kapsula iebsa
English: SPECIAL STORAGE CONDITIONS Store below 25°C.
Maltese: Aħżen f'temperatura taħt 25°C.
English: UNIQUE IDENTIFIER - 2D BARCODE Outer carton: 2D barcode carrying the unique identifier included.
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D Kartuna ta' barra: barcode 2D li jkollu l-identifikatur uniku inkluż.
English: Iron oxide colorant (E172)
Maltese: Kulur iron oxide (E172)
English: Clinical experience in pregnant women is limited, but congenital anomalies and abortions have been reported.
Maltese: L-esperjenza klinika f'nisa tqal hija limitata, imma ġew irrappurtati anomaliji konġenitali u abort.
English: Stavudine does not inhibit the major cytochrome P450 isoforms CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A4; therefore, it is unlikely that clinically significant drug interactions will occur with medicines metabolised through these pathways.
Maltese: Stavudine ma' jnaqqasx l-effett ta' l-iżoformi maġġuri taċ-ċitokromju P450 CYP1A2, CYP2C9, CYP2C19, CYP2D6 u CYP3A4; għalhekk, m'huwiex probabbli li stavudine jirreaġixxi b'mod klinikament sinifikanti ma' mediċini li jiġu metabolizzati b'dawn il-metodi.
English: The other ingredients of the powder are: cherry flavour, methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), silicon dioxide, simethicone, sodium carmellose, sorbic acid, stearate emulsifiers and sucrose.
Maltese: L-ingredjenti l-oħra tat-trab huma: benna taċ-ċirasa, methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), silicon dioxide, simethicone, sodium carmellose, sorbic acid, stearate emulsifiers u sucrose.
English: Binding of stavudine to serum proteins was negligible over the concentration range of 0.01 to 11.4 µg/ml.
Maltese: L-irbit ta' stavudine mal-proteini tas-serum kien negliġibbli fejn il-konċentrazzjoni kienet tvarja minn 0.01 sa 11.4 µg/ml.
English: At least 14 days old and < 30 kg ≥ 30 kg
Maltese: Għallinqas 14-il ġurnata u < 30 kg ≥ 30 kg
English: Pharmacotherapeutic group: antivirals for systemic use, nucleoside and nucleotide reverse transcriptase inhibitors, ATC code: J05AF04
Maltese: Kategorija farmakoterapewtika: antivirali għal użu sistemiku, inibituri nucleoside u nucleotide reverse transcriptase, kodiċi ATC:
English: rare: anaemia* very rare: neutropenia *, thrombocytopenia*
Maltese: rari: anemija* rari ħafna: newtropenija*, tromboċitopenija*
English: For storage conditions of the reconstituted medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħżin tal-prodott mediċinali rikostitwit, ara t-taqsima 6.3.
English: The powder contains 200 mg stavudine.
Maltese: It-trab fih 200 mg stavudine.
English: The AUC(inf) for stavudine was 61% of the AUC(inf) of the total circulating radioactivity.
Maltese: L-AUC(inf) għal stavudine kienet ta' 61 % tal-AUC(inf) tar-radjuattività totali li kienet tiċċirkola.
English: A MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release Bristol-Myers Squibb S.r.l., Contrada Fontana del Ceraso, 03012 Anagni (FR), Italy Aesica Queenborough Limited, North Road, Queenborough, Kent, ME11 5EL, United Kingdom The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Maltese: MILL-ĦRUĠ TAL-LOTT Isem u indirizz tal-manifattur(i) responsabbli mill-ħruġ tal-lott Bristol-Myers Squibb S.r.l., Contrada Fontana del Ceraso, 03012 Anagni (FR), L-Italja Aesica Queenborough Limited, North Road, Queenborough, Kent, ME11 5EL, Ir-Renju Unit Fuq il-fuljett ta' tagħrif tal-prodott mediċinali għandu jkun hemm l-isem u l-indirizz tal-manifattur responsabbli mill-ħruġ tal-lott ikkonċernat.