FrancophonIA/ELRC3.0 huggingface dataset:
English: - Do not administer in conjunction with other medicinal products.
Maltese: - Tamministrax ma prodotti oħra mediċinali.
English: Broached vial: 3 hours.
Maltese: Kunjett miftuħ: 3 sigħat.
English: 1 OJ No L 290 of 05.12.95 2 OJ No L 110 of 26.04.97 3 OJ No L 272 of 25.10.96 4 OJ No L 290 of 05.12.95 5 OJ No L 143 of 27.06.95
Maltese: 2 OJ Numru L 110 tas-26.04.97 3 OJ Numru L 272 tal-25.
English: In sows and gilts, the vaccine induces the specific seroconversion of vaccinated animals; piglets are passively immunised by intake of colostrum and milk containing adhesin-specific antibodies.
Maltese: Fil-majjaliet u fil-qażqużiet, il-vaċċin jinduċi seroconversion speċifiku tal-annimali imlaqqma; id-drafeġ huma immunizzati passivament billi jieħdu il-colostrum u l-ħalib li fih adhesin-specific antibodies.
English: 250 doses =100 ml vial.
Maltese: 50 doża kunjett ta' 100 ml
English: *: 1 SA.U: quantity sufficient to obtain an agglutinating antibody titre of 1 log10 in the guinea pig.
Maltese: 1 SA.U: kwantita' suffiċjenti biex ikollok titolu ta' agglutinating antibody ta' 1 log 10 fil-fenek ta' l-Indi.
English: Vaccination may cause a slight hyperthermia (less than 1.5°C during a maximum period of 24 hours).
Maltese: Il-vaċċin jista jikkaġuna hyperthermia ħafifa (inqas minn 1.5 ċentigradi waqt perjodu massimu ta' 24 siegħa).
English: EU/2/98/008/002 20 ml vial.
Maltese: EU/2/98/008/001 kunjett ta' 10 ml EU/2/98/008/002 kunjett ta' 20 ml EU/2/98/008/003 kunjett ta' 50 ml EU/2/98/008/004 kunjett ta' 100 ml
English: Aluminium (as hydroxide) .................................................................................... 1.4 mg
Maltese: Aluminju (bħala hydroxide) .......................................................................................................... 1.4 mg
English: Store and transport at 2°C - 8°C, protected from light.
Maltese: Aħżen u ttrasporta f'temperatura ta' 2°C - 8°C, protett mid-dawl.
English: No information is available on the compatibility of this vaccine with any other.
Maltese: M'hemm l-ebda informazzjoni dwar il-kompatibilità ta' dan il-vaċċin ma xi ieħor.
English: All food producing species For use only as a preservative in multidose vaccines at a concentration not exceeding 0.02%
Maltese: Biex jintuża biss bħala preservattiv fil-vaċċini multidoża b'konċentrat ta' mhux iżjed minn 0.02%.
English: Shelf-life: 18 months at 2 - 8 °C.
Maltese: Aħżen u ttrasporta f'temperatura ta' bejn 2 °C u 8°C protett mid-dawl.
English: The vaccine contains the inactivated strains of E. coli expressing the adhesins F4ab, F4ac, F4ad, F5, F6 and F41, which cause neonatal enterotoxicosis in piglets, in aluminium hydroxide adjuvant.
Maltese: Il-vaċċin fih l-istrains inattivati tal-E.coli li jesprimu l-adhesins F4ab, F4ac, F4ad, F5, F6 u F41, li jikkaġunaw enterotoxicosis fid-drafeġ tat-twelid, fl-adjuvant ta' l-aluminju hydroxide.
English: F4 (F4ab, F4ac, F4ad), at least .................................................................................................... 2.1 SA.U*
Maltese: E.coli adhesin F4 (F4ab, F4ac, F4ad), mill-inqas ....................................................................... 2.1 SA.
English: Adjuvant: Aluminium (as hydroxide) ............................................................................................................. 1.4 mg
Maltese: Aluminju (bħala hydroxide) ......................................................................................................... 1.4 mg
English: NAME OF THE VETERINARY MEDICINAL PRODUCT
Maltese: - Tamministrax ma prodotti oħra mediċinali
English: Adjuvanted inactivated vaccine for the reduction of neonatal enterotoxicosis of piglets, caused by E. coli strains, expressing the adhesins F4ab, F4ac, F4ad, F5, F6 and F41.
Maltese: Vaċċin inattivat bl-adjuvant għat-tnaqqis ta' enterotoxicosi fid-drafeġ tat-twelid, ikkaġunat mil istrains tal-E.coli li jesprimu l-adhesins F4ab, F4ac, F4ad, F5, F6 u F41.
English: D. STATEMENT OF THE MRLs WHICH ARE, ACCEPTED IN ACCORDANCE WITH COUNCIL REGULATION (EEC) No 2377/90
Maltese: Anness II tar-Regolament tal-Kunsill (KE) Nru 2377/90 Sustanza(i)
English: MARKETING AUTHORISATION HOLDER Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY
Maltese: Isem u indirizz tal-manufattur(i) tas-sustanza(i) bioloġika(ċi) attiva(i) Boehringer Ingelheim Vetmedica GmbH 55216
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances:
Maltese: TAS-SUSTANZA ATTIVA / SUSTANZI ATTIVI
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinstab fuq il-websajt ta' l-Aġenzija Ewropea għall-Mediċini http://ema.europa.eu
English: Pigs (sows and gilts)
Maltese: INDIKAZZJONI(JIET)
English: 2 ml = 1 dose 25 d
Maltese: 2 ml = doża 5d kunjett ta' 10 ml 2ml = doża 10d kunjett ta' 20 ml 2 ml = doża 25d kunjett ta' 50 ml
English: QUANTITY OF THE ACTIVE SUBSTANCE(S)
Maltese: TAS-SUSTANZA(I) BIOLOĠIKA(ĊI) ATTIVA(I)
English: E. coli adhesin F4 (F4ab, F4ac, F4ad), at least....................................................... 2.1 SA U* E. coli adhesin F5, at least ...................................................................................... 1.7 SA.U* E. coli adhesin F6, at least ...................................................................................... 1.4 SA.U* E. coli adhesin F41, at least .................................................................................... 1.7 SA.U*
Maltese: E. coli adhesin F4 (F4ab, F4ac, F4ad), mill-inqas ...................................................................... 2.1 SA.
English: Reduction of neonatal enterotoxicosis of piglets, caused by E. coli strains, expressing the adhesins F4ab, F4ac, F4ad, F5, F6 and F41, during the first days of life.
Maltese: Tnaqqis ta' enterotoxicosi fid-drafeġ tat-twelid, ikkaġunat mil-istrains tal-E.coli li jesprimu l-adhesins F4ab, F4ac, F4ad, F5, F6 u F41, fl-ewwel ftit jiem tal-ħajja.
English: Per dose of 2 ml:
Maltese: 1.4 mg
English: Primary vaccination:
Maltese: ATĊ kodiċi veterinarju:
English: MARKETING AUTHORISATION NUMBER(S)
Maltese: farmakoloġikament attiva(i)
English: F5, at least ................................................................................................................................... 1.7 SA.U*
Maltese: Thiomersal ................................................................................................................................... 0.2 mg Għal-lista sħiħa ta' l-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: PACKAGE LEAFLET Neocolipor
Maltese: KWALITAJIET IMMUNOLOĠIĊI
English: 10 ml vial
Maltese: MILL-HRUĠ TAL-LOTT
English: F6, at least ................................................................................................................................... 1.4 SA.U*
Maltese: U* E. coli adhesin F6, mill-inqas ...................................................................................................... 1.4 SA.
English: Intramuscular injection
Maltese: TAL-PRODOTT MEDIĊINALI
English: Veterinary medicinal product subject to prescription.
Maltese: Prodott mediċinali veterinarju li jingħata bil-preskrizzjoni.
English: 20 ml vial
Maltese: MILL-ĦRUĠ TAL-LOTT
English: For animal treatment only - to be supplied only on veterinary prescription.
Maltese: U L-UŻU Prodott mediċinali veterinarju mogħti biss bi preskrizzjoni.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA(I) BIOLOĠIKA(/BIOLOĠIĊI)
English: EU (MA) Number
Maltese: Numru tal-MA (EU) Isem (ivvintat)
English: Fresenius Kabi Oncology Plc, Lion Court, Farnham Road, Bordon, Hampshire, GU35 0NF, United Kingdom
Maltese: Fresenius Kabi Oncology Plc, Lion Court, Farnham Road, Bordon, Hampshire, GU35 0NF, Ir-Renju Unit
English: (CrCL=20-39 ml/min/1.73 m2, n=9), and Severe (CrCL < 20 ml/min/1.73 m2, n=3).
Maltese: (CrCL=20-39 ml/min/1.73 m2, n=9), u Qawwi (CrCL < 20 ml/min/1.73 m2, n=3).
English: d p-value from the Cochran Mantel-Haenszel chi-square test adjusted for the stratification factors; analysis by line of therapy excludes stratification for therapeutic history * CR+PR+MR **CR=CR, (IF-); nCR=CR (IF+)
Maltese: d valur-p mit-test chi-square Cochran Mantel-Haenszel aġġustat għal fatturi stratifikati; analiżi skont il-linja tat-terapija teskludi stratifikazzjoni għall-istorja terapewtika * CR+PR+MR**CR=CR, (IF-); nCR=CR (IF+)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1397/001
Maltese: EU/1/19/1397/001
English: Uncommon Fall, Contusion Rare
Maltese: Mhux komuni Waqgħa, Kontużjoni Rari
English: Higher incidences were also noted for infections with grade ≥ 3 neutropenia (24% versus 19% in Block 1 and 22% versus 11% in Block 2), increased ALT (17% versus 8% in Block 2), hypokalaemia (18% versus 6% in Block 1 and 21% versus 12% in Block 2) and hyponatraemia (12% versus 5% in Block 1 and 4% versus 0 in Block 2).
Maltese: Inċidenzi ogħla ġew ukoll innutati għal infezzjonijiet b'newtropenija bi grad ≥ 3 (24% versus 19% fi Blokk 1 u 22% versus 11% fi Blokk 2), żieda fl-ALT (17% versus 8% fi Blokk 2), ipokalimja (18% versus 6% fi Blokk 1 u 21% versus 12% fi Blokk 2) u iponatrimja (12% versus 5% fi Blokk 1 u 4% versus 0 fi Blokk 2).
English: For dose adjustments, see table 5 below.
Maltese: Għal aġġustamenti fid-doża, ara Tabella 5 taħt.
English: p-value d
Maltese: Valur p d
English: Intent to Treat Population b n=74
Maltese: Popolazzjoni Maħsuba għal Trattament b n=74
English: An odds ratio (OR) > 1 indicates an advantage for BR-CAP.
Maltese: Proporzjon ta' probabbiltà (OR - odds ratio) > 1 jindika vantaġġ għal BR-CAP.
English: (95% CI) p-value c
Maltese: (95% CI) Valur-p c
English: n: ITT patients Progression free survival (IRC)
Maltese: n: pazjenti ITT Sopravivenza ħielsa mill-progressjoni (IRC)
English: * Grouping of more than one MedDRA preferred term.
Maltese: * Aggruppament ta' aktar minn terminu wieħed ta' MedDRA huwa preferut
English: The analysis demonstrated improved ORR (CR+PR) (odds ratio 3.769; 95% CI 2.045-6.947; p < 0.001), PFS (hazard ratio 0.511; 95% CI 0.309-0.845; p=0.008), TTP (hazard ratio 0.385; 95% CI 0.212-0.698; p=0.001) for bortezomib in combination with dexamethasone over bortezomib monotherapy.
Maltese: p < 0.001), PFS (proporzjon ta' periklu 0.511; 95% CI 0.309-0.845; p=0.008), TTP (proporzjon ta' periklu 0.385; 95% CI 0.212-0.698; p=0.001) għal bortezomib f'kombinazzjoni ma' dexamethasone fuq il-monoterapija b'bortezomib.
English: Based on Kaplan-Meier product limit estimates.
Maltese: Stima Kaplan-Meier.
English: -- -- Day
Maltese: Jum -
English: IV on day 1; cyclophosphamide 750 mg/m
Maltese: cyclophosphamide 750 mg/m
English: Antiviral prophylaxis was administered to 137 of 240 patients (57%) in the BR-CAP arm.
Maltese: Profilassi antivirali ngħatat lill-137 minn 240 pazjent (57%) fil-fergħa ta' VcR-CAP.
English: This interim analysis showed a TTP risk reduction of 45% (95% CI; 29-57%, p < 0.0001) for patients treated with combination therapy of bortezomib and pegylated liposomal doxorubicin.
Maltese: Dan l-analiżi interim wera tnaqqis fir-riskju ta' TTP ta' 45 % (95 % CI; 29-57 %, p < 0.0001) għal pazjenti trattati b'terapija ta' kombinazzjoni ta' bortezomib u pegylated liposomal doxorubicin.
English: Day 1, 2, 3, 4 Day 8, 9, 10, 11Cycles 2 to 4
Maltese: Jum1, 2, 3, 4 Jum 8, 9, 10, 11Ċikli 2 sa 4
English: This medicine contains the active substance bortezomib, a so-called ‘proteasome inhibitor'.
Maltese: Din il-mediċina fiha s-sustanza attiva bortezomib, hekk imsejjaħ ‘impeditur ta' proteasome'.
English: Uncommon Cardiac tamponade
Maltese: Mhux komuni Tamponad kardijaku
English: A statistically significant benefit (p < 0.001) in favour of the BR-CAP treatment group over the R-CHOP group was observed for TTP (median 30.5 versus 16.1 months), TNT (median 44.5 versus 24.8 months) and TFI (median 40.6 versus 20.5 months).
Maltese: Benefiċċju statistikament sinifikanti (p < 0.001) favur il-grupp ta' trattament ta' VcR-CAP fuq il-grupp ta' R-CHOP ġie osservat għal TTP (medjan 30.5 versus 16.1 xhur), TNT (medjan 44.5 versus 24.8 xhur) u TFI (medjan 40.6 versus 20.5 xhur).
English: Once weekly bortezomib (cycles 5-9)
Maltese: Bortezomib darba fil-ġimgħa (ċikli 5-9)
English: What Bortezomib Fresenius Kabi contains - The active substance is bortezomib.
Maltese: X'fih Bortezomib Fresenius Kabi - Is-sustanza attiva hi bortezomib.
English: One single autologous stem cell transplant was received by 105 (81%) patients and 78 (61%) patients in the BTDx and TDx groups, respectively.
Maltese: Trapjanti ta' ċelluli steminali awtologi ġew mogħtija lil 105 (81%) u 78 (61%) pazjent fil-gruppi VcTDx u TDx, rispettivament.
English: p-value g=0.275
Maltese: 749; 2.722) valur p g=0.275
English: The overall best response rate (CR+PR), to retreatment in 130 patients was 38.5% (95% CI: 30.1,
Maltese: Ir-rata tal-aħjar rispons globali (CR + PR), għal trattament mill-ġdid lil 130 pazjent kien 38.5% (95% CI: 30.1, 47.4).
English: - Flush the peripheral or intravenous catheter with sterile, sodium chloride 9 mg/ml (0.9%) solution.
Maltese: - Aħsel il-kateter periferali jew fil-vina b'soluzzjoni sterili ta' 9 mg/ml (0.9%) ta' sodium chloride.
English: The AUClast geometric mean ratio was 0.99 and 90% confidence intervals were 80.18%-122.80%.
Maltese: last kien ta' 0.99 u l-intervalli ta' kunfidenza ta' 90% kienu 80.
English: Patients in the BTDx and TDx groups respectively had a median age of 57 versus 56 years, 99% versus 98% patients were Caucasians, and 58% versus 54% were males.
Maltese: Pazjenti fil-gruppi ta' trattament ta' BTDx u TDx rispettivament kellhom età medjana tal-pazjenti fl-istudju kienet ta' 57 sena kontra 56 sena, 99 % tal-pazjenti kienu Kawkasi, u 58 % kontra 54 % kienu rġiel.
English: Based on the limited contribution (7%) of CYP2D6 to the metabolism of bortezomib, the CYP2D6 poor metaboliser phenotype is not expected to affect the overall disposition of bortezomib.
Maltese: Skont il-kontribuzzjoni limitata (7 %) ta' CYP2DG għallmetaboliżmu ta' bortezomib, il-metabolizzatur batut b'fenotip CYP2D6 mhux mistenni li jaffettwa ddispożizzjoni ġenerali ta' bortezomib.
English: Uncommon Pulmonary embolism, Pleural effusion, Pulmonary oedema (inc acute), Pulmonary alveolar haemorrhage
Maltese: Mhux komuni Emboliżmu pulmonarju, Effużjoni plewrali, Edema pulmonari (li tista' tkun akuta), Bronkospażmu, Emorraġija alveolari pulmonari
English: A statistically significant survival benefit in favour of the B+M+P treatment group was observed (HR=0.695; p=0.00043) despite subsequent therapies including bortezomib-based regimens.
Maltese: Kien osservat benefiċċju ta' sopravivenza sinifikanti b'mod statistiku favur il-grupp ta' trattament B+M+P (HR=0.695; p=0.00043) minkejja terapiji sussegwenti li kienu jinkludu programmi ta' trattament ibbażati fuq Bortezomib.
English: Refers to response rate after second transplant for subjects who received a second transplant (42/240 [18%] in BDx group and 52/242 [21%] in VDDx group).
Maltese: Jirreferi għar-rata ta' rispons wara t-tieni trapjant għal individwi li rċevew it-tieni trapjant (42/240 [18%] fil-grupp ta' VcDx u 53/242 [21%] fil-grupp ta' VDDx)
English: #, Acne*, Blister*, Pigmentation disorder*
Maltese: #, Akne*, Infafet, Disturb fil pigmentazzjoni*
English: Very common Thrombocytopenia*, Neutropenia*, Anaemia* Common
Maltese: Komuni ħafna Tromboċitopenija*, Newtropenija*, Anemija* Komuni
English: Grade 1 with pain or grade 2 (moderate symptoms; limiting instrumental Activities of Daily Living (ADL)**)
Maltese: Grad 1 bl-uġigħ jew grad 2 (sintomi moderati: li jirristrinġu l-Attivitajiet strumentali tal-Ħajja ta' Kuljum (ADL - Activities of Daily Living))
English: In the BR-CAP group, 22.5% of patients received platelet transfusions compared to 2.9% of patients in the R-CHOP group.
Maltese: Filgrupp ta' BR-CAP, 22.5% tal-pazjenti rċivew trasfużjonijiet tal-plejtlets meta mqabbla ma' 2.9% talpazjenti fil-grupp ta' R-CHOP.
English: Discontinue bortezomib
Maltese: Mediċini oħra u bortezomib
English: Additional adverse drug reactions identified associated with the use of the combination therapy (BR-CAP) were hepatitis B infection (< 1%) and myocardial ischaemia (1.3%).
Maltese: Reazzjonijiet avversi addizjonali għall-mediċina li kienu identifikati u assoċjati mal-użu tat-terapija ta' kombinazzjoni (BR-CAP) kienu infezzjoni bl-epatite B (< 1%) u iskemija mijokardijaka (1.3%).
English: The incidence of herpes zoster among patients in the B+M+P treatment group was 17% for patients not administered antiviral prophylaxis compared to 3% for patients administered antiviral prophylaxis.
Maltese: L-inċidenza ta' herpes zoster fost pazjenti fil-grupp tat-trattament b'B+M+P kienet ta' 17 % għal pazjenti li ma ngħatawx profilassi antivirali meta mqabbel ma' 3 % għal pazjenti li ngħataw profilassi antivirali.
English: CR=Complete Response; nCR=near Complete response PR=Partial Response; MR=Minimal response
Maltese: CR = Rispons Kompleta (Complete Response); nCR= viċin ir-Rispons Kompleta (near Complete Response) PR = Rispons Parzjali (Partial Response);
English: 42.9% and 10.4% of patients in the BR-CAP arm were in the range 65-74 years and ≥ 75 years of age, respectively.
Maltese: 4% tal-pazjenti fil-fergħa ta' BR-CAP kienu fil-firxa ta' età bejn 65-74 sena u ≥ 75 sena, rispettivament.
English: a Intent to Treat (ITT) population b p-value from the stratified log-rank test; analysis by line of therapy excludes stratification for therapeutic history; p < 0.0001
Maltese: b valur-p mit-test log-rank stratifikat, analiżi skont il-linja ta' terapija teskludi l-istratifikazzjoni għall-istorja terapewtika; p<0.0001
English: In trials in which bortezomib was administered as induction treatment in combination with dexamethasone (study IFM-2005-01), and dexamethasone-thalidomide (study MMY-3010), the incidence of peripheral neuropathy in the combination regimens is presented in the table below:
Maltese: Fil-provi li fihom bortezomib ingħata bħala trattament ta' induzzjoni f'kombinazzjoni ma' dexamethasome (studju IFM-2005-01), u dexamethasone-thalidomide (studju MMY-3010), linċidenza ta' newropatija periferali fil-programmi ta' trattament ikkombinat qed jiġu ppreżentati fittabella t'hawn isfel:
English: Overall survival* Events (deaths) n (%) Median a
Maltese: Sopravivenza totali* Każijiet (imwiet) n (%) Medjan a
English: In patients with MCL (study LYM-3002), the incidence of herpes zoster infection was 6.7% in the BR-CAP arm and 1.2% in the R-CHOP arm (see section 4.8).
Maltese: F'pazjenti b'MCL (studju LYM-3002), l-inċidenza ta' infezzjoni b'herpes zoster kienet 6.7% filfergħa ta' BR-CAP u 1.2% fil-fergħa ta' R-CHOP (ara sezzjoni 4.8).
English: Retreatment of patients with relapsed multiple myeloma In a study in which bortezomib retreatment was administered in 130 patients with relapsed multiple myeloma, who previously had at least partial response on a bortezomib-containing regimen, the most common all-grade adverse events occurring in at least 25% of patients were thrombocytopenia (55%), neuropathy (40%), anaemia (37%), diarrhoea (35%), and constipation (28%).
Maltese: Fi studju li fih trattamenti konsekuttivi bi bortezomib ngħataw lil 130 pazjent b'majeloma multipla li rkadiet, li qabel kellhom tal-anqas rispons parzjali bi programm ta' trattament li kien fih bortezomib, l-aktar każijiet avversi ta' kull grad li seħħew f'tal-anqas 25% tal-poazjenti kienu tromboċitopenija (55 %), newropatija (40 %), anemija (37 %), dijarea (35 %) u stitikezza (28 %).
English: N=130 (ITT population) N=127 (ITT population)
Maltese: N=130 (popolazzjoni ITT)
English: Median survival for the B+M+P treatment group was 56.4 months compared to 43.1 for the M+P treatment group.
Maltese: Is-sopravivenza medjana fil-grupp ta' trattament B+M+P kienet 56.4 xhur ikkumparat ma' 43.1 fil-grupp ta' trattament M+P.
English: In the Phase III study in patients with previously untreated multiple myeloma, the overall incidence of herpes zoster reactivation was more common in patients treated with Bortezomib+Melphalan+Prednisone compared with Melphalan+Prednisone (14% versus 4% respectively).
Maltese: III f'pazjenti b'majeloma multipla li qatt ma kienet ittrattata qabel, l-inċidenza globali ta' riattivazzjoni ta' herpes zoster kien aktar komuni f'pazjenti ttrattati bi bortezomib +Melphalan+Prednisolone meta mqabbel ma' Melphalan+Prednisolone (14 % kontra 4 % rispettivament).
English: Uncommon Cushing's syndrome*, Hyperthyroidism*, Inappropriate antidiuretic hormone secretion
Maltese: Mhux komuni Sindromu ta' Cushing*, Ipertajroidiżmu*, Tnixxija mhux adattata tal-ormon antidijuretiku
English: The incidence of herpes zoster among patients in the BR-CAP arm was 10.7% for patients not administered antiviral prophylaxis compared to 3.6% for patients administered antiviral prophylaxis (see section 4.4).
Maltese: 7% għall-pazjenti li ma ngħatawx profilassi antivirali meta mqabbel ma' 3.6% għall-pazjenti li ngħataw profilassi antivirali (ara sezzjoni 4.4).
English: Progressive multifocal leukoencephalopathy (PML) Very rare cases with unknown causality of John Cunningham (JC) virus infection, resulting in PML and death, have been reported in patients treated with bortezomib.
Maltese: Lewkoenċefalopatija progressiva u multifokali (PML) Każijiet rari ħafna fejn mhux magħruf il-kawża għal infezjoni bil-virus John Cunningham (JC), li irriżultaw f'PML u mewt, ġew irrappurtati f'pazjenti li ġew trattati bi bortezomib.
English: • Risk management plan (RMP)
Maltese: • Pjan tal-Ġestjoni tar-Riskju (RMP)
English: In study IFM-2005-01 bortezomib combined with dexamethasone [BDx, n=240] was compared to vincristine-doxorubicin-dexamethasone [VDDx, n=242].
Maltese: Fl-istudju IFM-2005-01 bortezomib flimkien ma' dexamethasone [BDx, n=240] ġie mqabbel ma' vincristine-doxorubicin-dexamethasone [VDDx, n=242].
English: The two treatment groups were similar with regard to the overall incidence of all-grade bleeding events (6.3% in the BR-CAP group and 5.0% in the R-CHOP group) as well as grade 3 and higher bleeding events (BR-CAP: 4 patients [1.7%]; R-CHOP: 3 patients [1.2%]).
Maltese: Iż-żewġ gruppi ta' trattament kienu jixxiebhu f'dik li hija inċidenza totali ta' każijiet ta' fsada tal-gradi kollha (6.3% fil-grupp ta' BR-CAP u 5.0% fil-grupp ta' R-CHOP) kif ukoll każijiet ta' fsada ta' Grad 3 jew aktar (BR-CAP: 4 pazjenti [1.7%]; R-CHOP: 3 pazjenti [1.2%]).
English: Autologous stem cell transplants were received by 198 (82%) patients and 208 (87%) patients in the VDDx and BDx groups respectively; the majority of patients underwent one single transplant procedure.
Maltese: Trapjanti ta' ċelluli steminali awtologi ġew mogħtija f'198 (83%) u 208 (87%) tal-pazjenti fil-gruppi VDDx u BDx, rispettivament.
English: Note: Bortezomib is a cytotoxic agent.
Maltese: Nota: Bortezomib huwa sustanza ċitotossika.
English: Fertility Fertility studies were not conducted with bortezomib (see section 5.3).
Maltese: Fertilità Ma sarux studji dwar il-fertilità bi bortezomib (ara sezzjoni 5.3).
English: Disseminated intravascular coagulation, Thrombocytosis*, Hyperviscosity syndrome, Platelet disorder NOS, Thrombotic microangiopathy (including thrombocytopenic purpura)
Maltese: Koagulazzjoni intravaskulari mifruxa, Tromboċitosi*, Sindromu ta' Iperviskosità, Disturb fil-plejtlits NOS, Mikroanġiopatija trombotika (li jinkludi purpura tromboċitopenika)
English: • different reconstitution requirements for bortezomib 3.5 mg IV or SC use
Maltese: • ħtiġijiet ta' rikostituzzjoni differenti għall-użu ta' bortezomib 3.5 mg IV jew SC
English: Subcutaneous use: Add 1.4 ml sodium chloride 0.9% to make 2.5 mg/ml final concentration.
Maltese: Żid 1.4 ml ta' 0.9% sodium chloride sabiex tagħmel konċentrazzjoni finali ta' 2.5 mg/ml.
English: Hazard ratio b
Maltese: Proporzjon ta' periklu b