FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be closely observed for signs and symptoms of hypersensitivity reactions during and for at least 30 minutes following each injection of an intravenous iron medicine.
Maltese: Il-pazjenti għandhom jiġu ċċekkjati sew għal sinjali u sintomi ta' sensittività eċċessiva matul u għal tal-anqas 30 minuta wara kull injezzjoni ta' mediċina tal-ħadid li tingħata ġol-vina.
English: Although the data show a clear association of intravenous iron medicines and hypersensitivity reactions, the data cannot be used to detect any differences in the safety profile of the different iron medicines.
Maltese: Minkejja li d-dejta turi assoċjazzjoni ċara bejn il-mediċini tal-ħadid li jingħataw ġol-vina u r-reazzjonijiet ta' sensittività eċċessiva, id-dejta ma tistax tintuża biex jiġu identifikati xi differenzi fil-profil ta' sigurtà tal-mediċini tal-ħadid differenti.
English: • In view of the limitations of the data the Committee recommended further activities, including yearly reviews of allergic reaction reports and a study to confirm the safety of intravenous iron medicines.
Maltese: • Fid-dawl tal-limitazzjonijiet tad-dejta, il-Kumitat irrakkomanda attivitajiet ulterjuri, inkluż reviżjonijiet annwali ta' rapporti ta' reazzjonijiet allerġiċi u studju biex tiġi kkonfermata s-sigurtà tal-mediċini tal-ħadid li jingħataw ġol-vina.
English: • If you have signs of an allergic reaction (such as feeling dizzy, swelling of your face and difficulty breathing), you should tell your doctor or nurse straight away.
Maltese: • Jekk għandek sinjali ta' reazzjoni allerġika (bħal sturdament, nefħa fil-wiċċ u diffikultà biex tieħu nifs), għandek tgħid lit-tabib jew lill-infermier tiegħek minnufih.
English: • The risk of hypersensitivity is increased in patients with known allergies or immune or inflammatory conditions and in patients with a history of severe asthma, eczema or other atopic allergy.
Maltese: • Ir-riskju ta' sensittività eċċessiva huwa akbar f'pazjenti b'allerġiji magħrufa jew b'kondizzjonijiet immunitarji jew infjammatorji u f'pazjenti bi storja medika ta' ażżma severa, ekżema jew allerġija atopika oħra.
English: If you are receiving intravenous iron medicines your doctor will closely observe you for any allergic reactions during and for at least 30 minutes after the injection.
Maltese: Jekk qed tirċievi mediċini tal-ħadid li jingħataw ġol-vina, it-tabib tiegħek ser jiċċekkja sew jekk għandekx xi reazzjoni allerġika matul u tal-anqas għal 30 minuta wara l-injezzjoni.
English: You should also tell your doctor if you have certain conditions affecting the immune system and involving inflammation (such as rheumatoid arthritis), a history of asthma, eczema or other allergies, as this may make an allergic reaction to intravenous iron preparations more likely.
Maltese: Għandek tinforma lit-tabib tiegħek jekk għandek ċerti kundizzjonijiet li jaffettwaw lis-sistema immunitarja u li jinvolvu infjammazzjoni (bħal artrite rewmatojde), storja medika ta' ażżma, ekżema jew allerġiji oħrajn, peress li dawn probabbilment jistgħu jwasslu għal reazzjoni allerġika għall-preparazzjonijiet tal-ħadid li jingħataw ġol-vina.
English: • As there are data indicating that allergic reactions may still occur in patients who have not reacted to a test dose, a test dose is no longer recommended.
Maltese: • Peress li hemm dejta li tindika li xorta waħda jistgħu jseħħu reazzjonijiet allerġiċi f'pazjenti li ma kellhomx reazzjoni għal doża tat-test, ma għadux irrakkomandat li tingħata doża tat-test.
English: Strength Pharmaceutical Form
Maltese: Numru ta' l-UE Isem ivvintat Qawwa Għamla Farmaċewtika
English: (Invented) name Strength Pharmaceutical form Route of administration
Maltese: Qawwa Għamla farmaċewtika
English: Method of administration
Maltese: Metodu ta 'amministrazzjoni
English: Complete (Confirmed3) [95% CI] Partial
Maltese: Komplet (Konfermati3) [95% CI] Parzjali
English: Contains lecithin (soya) (E322).
Maltese: Fih lecithin (soya) (E322).
English: Confusional state
Maltese: Stat konfużjonali
English: Study AAU02
Maltese: Studju AAU02
English: Consolidation (de novo Ph+ ALL)
Maltese: Konsolidazzjoni (de novo Ph+ ALL)
English: Days 2, 3, 16, and 17
Maltese: Jiem 2, 3, 16, u 17
English: Study AJP01
Maltese: Studju AJP01
English: Pericarditis*, cardiac tamponade*
Maltese: Perikardite*, tamponade kardijaku*
English: Consolidation therapy I, III, V
Maltese: Terapija ta' konsolidazzjoni I, III, V
English: Polyvinyl alchol part. hydrolised Talc
Maltese: Qoxra tal-pillola Polyvinyl alchol part. hydrolised Talc
English: Study AUS01
Maltese: Studju AUS01
English: Date of first authorisation: 17 April 2013
Maltese: Data tal-ewwel awtorizzazzjoni: 17 ta' April 2013
English: Study ADE04
Maltese: Studju ADE04
English: Consolidation therapy II, IV
Maltese: Terapija ta' konsolidazzjoni II, IV
English: One blister contains 10 tablets.
Maltese: Folja waħda fiha 10 pilloli.
English: Bilirubin elevation was below 3%.
Maltese: Iż-żieda fil-bilirubin kienet taħt 3%.
English: Induction therapy (de novo Ph+ ALL)
Maltese: Terapija ta' induInduction therapy (de novo Ph+ ALL)
English: CML in blast crisis and Ph+ ALL (starting dose 600 mg)
Maltese: CML fil-blast crisis u Ph+ ALL (doża tal-bidu 600 mg)
English: IJsland/Islande/Island Tél/Tel: +354 5503300
Maltese: Islande/Island Tél/Tel: +354 5503300
English: Cellulose microcrystalline Copovidone
Maltese: Kontenut tal-kapsula Cellulose microcrystalline Copovidone
English: <2D barcode carrying the unique identifier included.>
Maltese: <Barcode 2D li jkollu l-identifikatur uniku inkluż.>
English: Study 0102 38-month data Myeloid blast crisis (n=260) % of patients (CI95%)
Maltese: Studju 0102 Dejta ta' 38 xahar Majelojd blast crisis (n=260) % tal-pazjenti (CI95%)
English: In vitro, imatinib inhibits paracetamol O-glucuronidation with Ki value of 58.5 micromol/L.
Maltese: In-vitro, imatinib jinibixxi paracetamol O-glucuronidation b'valur Ki ta' 58.5 mikromol/L.
English: Lymphoid blast crisis: a limited number of patients were enrolled in phase I studies (n=10).
Maltese: Limfojd blast crisis: numru limitat ta' pazjenti kienu reklutati fi studji ta' fażi I (n=10).
English: Ileus/intestinal obstruction*, gastrointestinal perforation*, diverticulitis*, gastric antral vascular ectasia (GAVE)*
Maltese: Ileus/imblukkar tal-imsaren*, titqib gastro-intestinali*, divertikulite*, ektażja vaskulari tal-antrum tal-istonku (GAVE)*
English: Vascular disorders4
Maltese: Disturbi vaskulari4
English: Myeloid blast crisis: 260 patients with myeloid blast crisis were enrolled.
Maltese: Majelojd blast crisis: 260 pazjent b'majelojd blast crisis kienu reklutati.
English: 11 Ion Mihalache Blvd Bucharest
Maltese: Sindan-Pharma S.R.L. 11 Ion Mihalache Blvd Bucharest
English: In GIST patients (study B2222), 6.8% of grade 3 or 4 ALT (alanine aminotransferase) elevations and 4.8% of grade 3 or 4 AST (aspartate aminotransferase) elevations were observed.
Maltese: F'pazjenti b'GIST (studju B2222), żiediet ta' 6.8% tal-grad 3 jew 4 ALT (alanine aminotransferase) u żiediet ta' 4.8% ta' grad 3 jew 4 AST (aspartate aminotransferase) kienu evidenti.
English: Do not take Imatinib Actavis:
Maltese: Tiħux Imatinib Actavis:
English: DAUN (45 mg/m2/day bolus, IV): days 1 and 2
Maltese: DAUN (45 mg/m2/kuljum bolus, IV): jiem 1 u 2
English: Cytogenetic abnormalities were evaluated in 117 of the total population of 176 patients.
Maltese: Anormalitajiet ċitoġenetiċi kienu evalwati f'117, mill popolazzjoni totali ta' 176 pazjent.
English: PEG-ASP (2500 IUnits/m2, IM): day 4
Maltese: PEG-ASP (2500 IUnitajiet/m2, IM): jum 4
English: MDS/MPD (starting dose 400 mg)
Maltese: MSD/MPD (doża tal bidu 400 mg)
English: - adult patients with Ph+ CML in blast crisis.
Maltese: - pazjenti adulti b'Ph+ CML li jkunu fi blast crisis.
English: - Chronic myeloid leukaemia (CML).
Maltese: - Lewkimja majelojd kronika (chronic myeloid leukaemia (CML)).
English: BM = bone marrow, PB = peripheral blood
Maltese: BM = Mudullun, PB = demm fil-periferiji
English: Total bilirubin: >1.5-3.0 ULN AST: any
Maltese: Bilirubin totali: >1.5-3.0 ULN
English: Triple IT therapy (age-adjusted): days 1, 29 VCR (1.5 mg/m2, IV): days 1, 29
Maltese: Terapija IT tripla (aġġustata skont l-età): jiem 1, 29 VCR (1.5 mg/m2, IV): jiem 1, 29
English: HES/CEL (starting dose 100 mg)
Maltese: HES/CEL (doża tal bidu 100 mg
English: - The active substance is imatinib (as mesilate).
Maltese: - Is-sustanza attiva hi imatinib (bħala mesilate).
English: 1800 to 3200 mg (as high as 3200 mg daily for 6 days): Weakness, myalgia, increased creatine phosphokinase, increased bilirubin, gastrointestinal pain.
Maltese: 1800 sa 3200 mg (sa doża għolja ta' 3200 mg kuljum għal 6 ijiem): Dgħufija, majalġja, żieda filcreatine phosphokinase, żieda fil-bilirubin, uġigħ gastrointestinali.
English: Palmoplantar erythrodysesthesia syndrome*, lichenoid keratosis*, lichen planus*, toxic epidermal necrolysis*, drug rash with eosinophilia and systemic symptoms (DRESS)*, pseudoporphyria*
Maltese: Sindrome ta' eritrodisasteżija palmoplantari*, keratożi lichenoid*, lichen planus*, nekrolisi tossika tal-epidermide*, raxx ikkawżat mill-mediċina b'eosinofilja u sintomi sistemiċi (DRESS - drug rash with eosinophilia and systemic symptoms)*, psewdoporfirja*
English: Total bilirubin: = 1.5 ULN
Maltese: Bilirubin totali: = 1.5
English: When the response rate is calculated from patients with at least one valid assessment, the response rate for CHR, CCyR and MR was 20/22 (90.9%), 9/9 (100%) and 11/17 (64.7%), respectively.
Maltese: Meta rrata ta' rispons huwa kkalkulat minn pazjenti li għandhom ta' l-inqas stima waħda valida, ir-rata ta' rispons għal CHR, CCyR u MR kien 20/22 (90.9%), 9/9 (100%) u 11/17 (64.7%), rispettivament .
English: The plasma protein binding of the N-demethylated metabolite is similar to that of the parent compound.
Maltese: Il-proteina tal-plażma tal metabolit N-demethylated huwa simili għal dak tal-komponent prinċipali.
English: days 2 and 3
Maltese: dożi)iii: jiem 2 u 3
English: Triple IT therapy (age-adjusted): days 1 and 22
Maltese: Terapija IT tripla (aġġustata skont l-età): jiem 1 u 22
English: methylprednisolone 40 mg intrathecal, day 1
Maltese: methylprednisolone 40 mg għal ġot-teka, jum 1
English: - Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL).
Maltese: - Sindrome ipereżinofilika (Hypereosinophilic syndrome (HES)) u/jew Lewkimja eżinofilika kronika (chronic eosinophilic leukaemia (CEL)).
English: 24 hard capsules 48 hard capsules 60 hard capsules 96 hard capsules 120 hard capsules 180 hard capsules
Maltese: 24 kapsuli iebsin 48 kapsuli iebsin 60 kapsuli iebsin 96 kapsuli iebsin 120 kapsuli
English: 2 Cytogenetic response criteria:
Maltese: 2 Kriterji għar-risponsijiet ċitoġenetiċi:
English: Imatinib Actavis contains lecithin (soya)
Maltese: Imatinib Actavis fih lecithin (soya)
English: EU/1/13/825/001 30 capsules EU/1/13/825/002 90 capsules
Maltese: EU/1/13/825/001 30 kapsuli EU/1/13/825/002 90 kapsuli
English: - Rash.
Maltese: Raxx.
English: Acute respiratory failure11*, interstitial lung disease*
Maltese: Insuffiċjenza respiratorja akuta11*, marda tal-interstizju tal-pulmun*
English: Hyperkalaemia, hypomagnesaemia
Maltese: Iperkalimija, ipomagneżimja
English: One blister contains 10 capsules.
Maltese: Folja waħda fiha 10 kapsuli.
English: Pack containing either 10, 30, 60, or 90 capsules.
Maltese: Pakketi li fihom 10, 30, 60 jew 90 kapsuli.
English: Pack containing either 24, 48, 60, 96, 120 or 180 capsules
Maltese: Pakketi li fihom 24, 48, 60, 96, 120 jew 180 kapsuli.
English: G-CSF (5 μg/kg, SC): days 27-36 or until ANC > 1500 post nadir ARA-C (3 g/m2, q12h, IV): days 43, 44
Maltese: G-CSF (5 μg/kg, SC): jiem 27-36 jew sa ANC > 1500 post nadir ARA-C (3 g/m2, q12h, IV): jiem 43, 44
English: The translocation t(17:22)[(q22:q13)], or its gene product, was present in nearly all responders to imatinib treatment.
Maltese: Ittranslokazzjoni t(17:22)[(q22:q13)], jew il-prodott tal-ġene tiegħu, instab fil-pazjenti kollha li urew rispons għall-kura b'imatinib.
English: The active substance imatinib demonstrates an environmental risk for sediment organisms.
Maltese: Is-sustanza attiva imatinib uriet riskju ambjentali għall-organiżmi sedimentali.
English: CPM (300 mg/m2, IV): days 29-33
Maltese: CPM (300 mg/m2, IV): jiem 29-33
English: Mean absolute bioavailability for imatinib is 98%.
Maltese: Il-biodisponibiltà assoluta medja għall-imatinib hi ta' 98%.
English: Methotrexate (20 mg/m2/week, PO): days 1, 8, 15, 22, 29, 36, 43, 50
Maltese: Methotrexate (20 mg/m2/ġimgħa, PO): jiem 1, 8, 15, 22, 29, 36, 43, 50
English: Methotrexate (20 mg/m2/week, PO): days 8, 15, 22 VP-16 (100 mg/m2, IV): days 29-33
Maltese: Methotrexate (20 mg/m2/ġimgħa, PO): jiem 8, 15, 22 VP-16 (100 mg/m2, IV): jiem 29-33
English: Imatinib did not interfere with the biotransformation of 5-fluorouracil, but it inhibited paclitaxel metabolism as a result of competitive inhibition of CYP2C8 (Ki - 34.7 µM).
Maltese: Imatinib ma fixkilx ilbiotrasformazzjoni ta' 5-fluoruracil, iżda inibixxa l-metaboliżmu ta' paclitaxel billi inibixxa b'mod kompetittiv lill-CYP2C8 (Ki=34.7 µM).
English: In adults the dose should be reduced from 400 to 300 mg or from 600 to 400 mg, or from 800 mg to 600 mg, and in children from 340 to 260 mg/m2/day.
Maltese: F' adulti id-doża għandha titnaqqas minn 400 mg għal 300 mg jew minn 600 mg għal 400 mg, jew minn 800 mg għal 600 mg, u fit-tfal minn 340 għal 260 mg/m2/jum.
English: Haemolytic anaemia, thrombotic microangiopathy
Maltese: Anemija emolitika, mikroanġjopatija trombotika
English: Hepatitis B reactivation*
Maltese: Riattivazzjoni tal-epatite B*
English: Tumour haemorrhage/tumour necrosis*
Maltese: Emorraġija mit-tumur/nekrożi tat-tumur*
English: Consolidation therapy
Maltese: Terapija ta' konsolidazzjoni
English: (1 h), days 28-31, 35-38, 42-45; 6-MP 60 mg/m2 oral, days 26-46
Maltese: 31, 35-38, 42-45; 6-MP 60 mg/m2 orali, jum 26-46
English: 6-MP (75 mg/m2/day, PO): days 11-56 (Withhold 6-MP during the 6-10 days of cranial irradiation beginning on day 1 of Cycle 5.
Maltese: 6-MP (75 mg/m2/kuljum, PO): jiem 11-56 (Miżmuma 6-MP matul is6-10 ijiem ta' irradjazzjoni kranjali mibdija fl-1 ġurnata ta' Ċiklu 5.
English: 6-MP (75 mg/m2/day, PO): days 1-56
Maltese: 6-MP (75 mg/m2/kuljum, PO): jiem 1-56
English: Al/PVC/Aclar blister.
Maltese: Folji ta' l-aluminium/PVC/Aclar.
English: • Periodic safety update reports
Maltese: • Rapporti perjodiċi ta 'aġġornament tas-sigurtà
English: - The other ingredients are cellulose microcrystalline, copovidone, crospovidone, sodium stearyl fumarate, silica (colloidal hydrophobe and colloidal anhydrous), polyvinyl alcohol partly hydrolysed, talc, yellow iron oxide (E172), titanium dioxide (E171), red iron oxide (E172), lecithin (soya) (E322), xanthan gum (E415).
Maltese: - Is-sustanzi l-oħra huma microcrystalline cellulose, copovidone, crospovidone, sodium stearyl fumarate, silica (colloidal hydrophobe u colloidal anhydrous), polyvinyl alcohol partly hydrolysed, talc, yellow iron oxide (E172), titanium dioxide (E171), red iron oxide (E172), lecithin (soya) (E322), xanthan gum (E415).
English: G-CSF = granulocyte colony stimulating factor, VP-16 = etoposide, MTX = methotrexate, IV = intravenous, SC = subcutaneous, IT = intrathecal, PO = oral, IM = intramuscular, ARA-C = cytarabine, CPM = cyclophosphamide, VCR = vincristine, DEX = dexamethasone, DAUN = daunorubicin, 6-MP = 6-mercaptopurine, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2-mercaptoethane sulfonate sodium, iii= or until MTX level is < 0.1 µM, q6h = every 6 hours, Gy= Gray
Maltese: cytarabine, CPM = cyclophosphamide, VCR = vincristine, DEX = dexamethasone, DAUN = daunorubicin, 6-MP = 6-mercaptopurine, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2-mercaptoethane sulfonate sodium, iii= jew sa meta l-livell ta' MTX ikun < 0.1 µM, q6h = kull 6 sigħat, Gy= Gray
English: BCR-ABL tyrosine kinase inhibitors (TKIs) have been associated with thrombotic microangiopathy (TMA), including individual case reports for Imatinib Actavis (see section 4.8).
Maltese: mikroanġjopatija trombotika (TMA - thrombotic microangiopathy), inklużi rapporti ta' każijiet individwali għal Imatinib Actavis (ara sezzjoni 4.8).
English: Specifar ABEE Τηλ: +30 2105401500
Maltese: Ελλάδα Τηλ: +30 2105401500
English: 30 hard capsules 90 hard capsules
Maltese: 30 kapsuli iebsin 90 kapsuli iebsin
English: Patients were treated at doses of imatinib of 260 mg/m2/day (n=5), 340 mg/m2/day (n=9), 440 mg/m2/day (n=7) and 570 mg/m2/day (n=5).
Maltese: 340 mg/m2/jum (n=9), 440 mg/m2/jum (n=7), u 570 mg/m2/jum (n=5).
English: VCR 1.3 g/m2 i.v., day 1; prednisolone 60 mg/m2 oral, days 1-5
Maltese: VCR 1.3 g/m2 i.v., jum 1; prednisolone 60 mg/m2 orali, jum 1-5
English: Ifosfamide (1.8 g/m2/day, IV): days 1-5
Maltese: Ifosfamide (1.8 g/m2/kuljum, IV): jiem 1-5
English: A further 162 patients with HES/CEL, reported in 35 published case reports and case series received imatinib at doses from 75 mg to 800 mg daily.
Maltese: 162 pazjent ieħor b'HES/CEL, rappurtati f'35 rapporti ta' każijiet u serje ta' każijiet li ġew publikati irċevew imatinib b'dożi ta' bejn 75 mg sa 800 mg kuljum.
English: 10 hard capsules 30 hard capsules 60 hard capsules 90 hard capusles
Maltese: 10 kapsuli iebsin 30 kapsuli iebsin 60 kapsuli iebsin 90 kapsuli iebsin
English: In the clinical study 38% of patients were ≥ 60 years of age and 12% of patients were ≥ 70 years of age.
Maltese: Fl-istudju kliniku 38% tal-pazjenti kellhom ≥ 60 sena u 12% tal-pazjenti kellhom ≥ 70 sena.
English: VP-16 (100 mg/m2/day, IV): days 1-5
Maltese: VP-16 (100 mg/m2/kuljum, IV): jiem 1-5
English: Capsule content: cellulose microcrystalline, copovidone, crospovidone, sodium stearyl fumarate, silica (colloidal hydrophobic and colloidal anhydrous).
Maltese: Kontenut tal-kapsula: microcrystalline cellulose, copovidone, crospovidone, sodium stearyl fumarate, silica (colloidal hydrophobic u colloidal anhydrous).
English: When assuming conservatively that patients with missing data were non-responders, CHR was observed in 20/23 (87%) patients, CCyR in 9/23 (39.1%) patients, and MR in 11/23 (47.8%) patients, respectively.
Maltese: Meta wieħed jassumi b'mod konservattiv li l-pazjenti b'dejta nieqsa kienu ma rrispondewx, CHR kien osservat f'20/23 (87%) pazjent, CCyR f'9/23 (39.1%) pazjent, u MR fi 11/23 (47.8%) pazjent, rispettivament .
English: Total bilirubin: >3-10 ULN AST: any ULN = upper limit of normal for the institution AST = aspartate aminotransferase
Maltese: ULN = il-limitu ta' fuq in-normal ta' l-instituzzjoni AST = aspartate aminotransferase
English: - Bruising.
Maltese: - Tbenġil.
English: The complete molecular response rate was 48% (49 out of 102 evaluable patients).
Maltese: Ir-rata kompleta ta' rispons molekulari kienet ta' 48% (49 minn 102 pazjent li setgħu jkunu evalwati).
English: ARA-C (3 g/m2/dose q 12 h x 4, IV): days 2 and 3 G-CSF (5 μg/kg, SC): days 4-13 or until ANC > 1500 post nadir
Maltese: ARA-C (3 g/m2/doża q 12 h x 4, IV): jiem 2 u 3 G-CSF (5 μg/kg, SC): jiem 4-13 jew sa ANC > 1500 post nadir
English: 11th Ion Mihalache Ave, The 1st district, RO-011171 Bucharest
Maltese: RO-011171 Bucharest Romania
English: Additionally, partial cytogenetic response (PCyR) was observed in 16% for a MCyR of 81%.
Maltese: Minbarra hekk, rispons ċitoġenetiku parzjali (PCyR) kien evidenti f'16% għal MCyR ta' 81%.
English: MESNA (150 mg/m2/day, IV): days 22-26
Maltese: MESNA (150 mg/m2/kuljum, IV): jiem 22-26
English: Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitor, ATC code: L01XE01
Maltese: Aġenti anti-neoplastiċi, inibitur tal-proteina kinase, Kodiċi ATC:
English: aANC < 0.5 x 109/L and/or platelets < 10 x 109/L
Maltese: aANC < 0.5 x 109/L u/jew plejtelets < 10 x 109/L
English: DEX (6 mg/m2/day, PO): days 1-7 and 15-21
Maltese: DEX (6 mg/m2/kuljum, PO): jiem 1-7 u 15-21
English: CPM (250 mg/m2/dose q12h x 4 doses, iv): Days 3 and 4
Maltese: CPM (250 mg/m2/doża q12h x 4 dożi, iv): Jiem 3 u 4
English: In eleven patients PDGFR gene rearrangements was detected, 9 of them achieved a CHR and 1 PHR.
Maltese: tibdil fil-ġene PDGFR kien misjub, 9 minnhom kisbu CHR u 1 PHR.
English: An additional four HES patients were found to be FIP1L1-PDGFRα-positive in other 3 published reports.
Maltese: Erba' pazjenti oħra instabu posittivi għal FIP1L1-PDGFRα f'3 rapporti oħra li ġew publikati.
English: Improvements were reported in cardiac, nervous, skin/subcutaneous tissue, respiratory/thoracic/mediastinal, musculoskeletal/connective tissue/vascular, and gastrointestinal organ systems.
Maltese: Titjieb kienu rappurtati fis-sistemi kardijaċi, nervużi, ġilda/tessut ta' taħt il-ġilda, respiratorju/toraċiku/medjastinali/muskolu skeletrali/ tessut konnettiv/vaskulari, u organi gastro-intestinali.
English: terfenadine, bortezomib, docetaxel, quinidine) or warfarin and other coumarin derivatives (see section 4.5).
Maltese: diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel, quinidine) jew warfarin jew derivattivi oħrajn ta' coumarin (ara sezzjoni 4.5).
English: DFSP (at dose 800 mg) ANC < 1.0 x 109/L and/or platelets < 50 x 109/L
Maltese: DFSP (f'doża 800 mg) ANC < 1.0 x 109/L u/jew plejtelets < 50 x 9/L
English: Ki values in human liver microsomes were 27, 7.5 and 7.9 μmol/L, respectively.
Maltese: Il-valuri Ki fil-mikrosomi tal-fwied tal-bniedem kienu 27, 7.5 u 7.9 µmol/l, rispettivament.
English: Acute febrile neutrophilic dermatosis (Sweet's syndrome), nail discolouration, angioneurotic oedema, rash vesicular, erythema multiforme, leucocytoclastic vasculitis, Stevens-Johnson syndrome, acute generalised exanthematous pustulosis (AGEP)
Maltese: Dermatożi newtrofilika bid-deni akuta (sindrome ta' Sweet), telf ta' kulur fiddwiefer, edima anġionewrotika, raxx bl-infafet, eritema multiforme, vaskulite lewkoklastika, sindrome ta' Stevens-Johnson, pustulożi ekżantematuża mifruxa akuta (AGEP)
English: Vitreous haemorrhage*
Maltese: Emorraġija fil-vitriju*
English: The median time to progression in the overall population of 411 patients with relapsed/refractory Ph+ ALL ranged from 2.6 to 3.1 months, and median overall survival in the 401 evaluable patients ranged from 4.9 to 9 months.
Maltese: Il-ħin medjan għall-progressjoni fil-popolazzjoni ġenerali ta' 411 pazjent b' Ph+ ALL li jirkadi/rifrattorju kienet bejn 2.6 u 3.1 xhur, u s-sopravivenza medja globali fil-401 pazjent li setgħu jiġu evalwati kienet bejn 4.9 u 9 xhur.
English: Imatinib in combination with chemotherapy induction (see Table 3) resulted in a complete haematological response rate of 93% (147 out of 158 evaluable patients) and in a major cytogenetic response rate of 90% (19 out of 21 evaluable patients).
Maltese: Imatinib flimkien ma' induzzjoni b'kemoterapija (ara Tabella 3) irriżulta f'rata ta' rispons ematoloġiku komplet ta' 93% (147 minn 158 pazjent li setgħu jkunu evalwati) u f'rata ta' rispons citoġenetika maġġuri ta' 90% (19 minn 21 pazjent li setgħu jkunu evalwati).
English: - adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
Maltese: tkabbir derivat minn plejtlets (platelet-derived growth factor receptor (PDGFR)).
English: Printing ink: shellac, black iron oxide (E172), propylene glycol, ammonia solution, potassium hydroxide.
Maltese: Inka ta' listampar: shellac, black iron oxide (E172), propylene glycol, ammonia solution, potassium hydroxide.
English: Printing ink: shellac glaze-45%, black iron oxide (E172), propylene glycol, ammonium Hydroxide 28%.
Maltese: Inka ta' l-istampar: shellac glaze-45%, black iron oxide (E172), propylene glycol, ammonium hydroxide 28%.
English: EU/1/13/825/003 24 capsules EU/1/13/825/004 48 capsules EU/1/13/825/019 60 capsules EU/1/13/825/005 96 capsules EU/1/13/825/006 120 capsules EU/1/13/825/007 180 capsules
Maltese: EU/1/13/825/003 24 kapsuli EU/1/13/825/004 48 kapsuli EU/1/13/825/019 60 kapsuli EU/1/13/825/005 96 kapsuli EU/1/13/825/006 120 kapsuli EU/1/13/825/007 180 kapsuli
English: Other medicines and Imatinib Actavis
Maltese: Mediċini oħra u Imatinib Actavis
English: Pleural effusion5, pharyngolaryngeal pain, pharyngitis
Maltese: Effużjoni fil-plewra5, uġigħ fil-farinġi u fil-larinġi, farinġite