FrancophonIA/ELRC3.0 huggingface dataset:
English: However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Madankollu, id-detentur tal-awtorizzazzjoni fis-suq għandu jissottometti rapporti perjodiċi ta' aġġornament tas-sigurta' għal dan il-prodott mediċinali jekk ilprodott jiġi inkluż fil-lista ta 'dati ta' referenza tal-Unjoni (lista EURD) previsti taħt l-Artikolu 107c (7)
English: Herpes zoster, herpes simplex, nasopharyngitis, pneumonia1, sinusitis, cellulitis, upper respiratory tract infection, influenza, urinary tract infection, gastroenteritis, sepsis
Maltese: Herpes zoster, herpes simplex, nasofarinġite, pulmonite1, sinużite, ċellulite, infezzjoni tan-naħa ta' fuq tal-passaġġ respiratorju, influwenza, infezzjoni tal-passaġġ tal-awrina, gastro-enteretite, sepsi
English: Intensification block 1 (9 weeks)
Maltese: Blokk 1 ta' intensifikazzjoni
English: Maintenance (8-week cycles) Cycle 5
Maltese: Manteniment (ċikli ta' 8 ġimgħat)
English: Capsule shell: hypromellose, titanium dioxide (E171), yellow iron oxide (E172).
Maltese: Qoxra tal-kapsula: hypromellose, titanium dioxide (E171), yellow iron oxide (E172).
English: Eye irritation, eye pain, orbital oedema, scleral haemorrhage, retinal haemorrhage, blepharitis, macular oedema
Maltese: Irritazzjoni ta' l-għajnejn, uġigħ fl-għajnejn, edema orbitali, emorraġija fl isklera, emorraġija fir-retina, blefarite, edema makulari
English: Imatinib Actavis 400 mg hard capsules EU/1/13/825/020
Maltese: Imatinib Actavis 400 mg kapsuli iebsin EU/1/13/825/020
English: Tumour lysis syndrome
Maltese: Sindrome tad-diżintegrazzjoni tat-tumur
English: VCR (1.5 mg/m2/day, IV): days 1, 29
Maltese: VCR (1.5 mg/m2, IV): jiem 1, 29
English: Clinical studies in DFSP One phase II, open label, multicentre clinical trial (study B2225) was conducted including 12 patients with DFSP treated with imatinib 800 mg daily.
Maltese: II, open label, f'ħafna ċentri (studju B2225) kienet imwettaqa b'12-il pazjent b'DFSP kurata b'imatinib 800 mg kuljum.
English: Imatinib Actavis 50 mg capsules imatinib
Maltese: Imatinib Actavis 50 mg kapsuli imatinib
English: Imatinib Actavis 400 mg tablets imatinib
Maltese: Imatinib Actavis 400 mg pilloli imatinib
English: When given with a high-fat meal, the rate of absorption of imatinib was minimally reduced (11% decrease in Cmax and prolongation of tmax by 1.5 h), with a small reduction in AUC (7.4%) compared to fasting conditions.
Maltese: Meta ingħata fl-istess ħin ma' ikla li kien fiha ħafna xaħam, ir-rata li biha imatinib ġie assorbit tnaqqset b'ammont minimu (tnaqqis bi 11% fis-Cmax u titwil tat-tmax b' 1.5 sigħat), bi tnaqqis żgħir fl-AUC (7.4%) meta mqabbla ma' dawk ta' pazjenti sajmin.
English: - adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.
Maltese: - pazjenti adulti u pedjatriċi li jkunu għadhom kif ġew dijanjostikati pożittivi għal-lewkimja limfoblastika akuta b'kromosoma ta' Filadelfja (Ph+ ALL), integrata mal-kemoterapija.
English: - adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement.
Maltese: (HES)) u/jew lewkimja kronika eżinofolika (chronic eosinophilic leukaemia (CEL)) b'bidla fl arranġament ta' FIP1L1-PDGFRα.
English: (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000),
Maltese: Il-kategoriji tal-frekwenzi huma definiti bl-użu ta' din il-konvenzjoni li jmiss: 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).
English: The 23 patients enrolled in this registry received imatinib at a median daily dose of 264 mg (range: 100 to 400 mg) for a median duration of 7.2 years (range 0.1 to 12.7 years).
Maltese: It-23 pazjent rreġistrati f'dan ir-reġistru rċevew imatinib f'doża medja ta' 264mg kuljum (firxa: 100 għal 400 mg) għal tul medju ta' 7.2 sena (medda 0.1 sa 12.7 sena).
English: - Itching.
Maltese: tinqasam.
English: Imatinib Actavis 400 mg capsules imatinib
Maltese: Imatinib Actavis 400 mg kapsuli imatinib
English: Each capsule contains 50 mg imatinib (as mesilate).
Maltese: Kull kapsula fiha 50 mg imatinib (bħal mesilate).
English: Imatinib Actavis 50 mg hard capsules EU/1/13/825/001
Maltese: Imatinib Actavis 50 mg kapsuli iebsin EU/1/13/825/001
English: (1 h), days 26, 46; Ara-C 75 mg/m2 i.v.
Maltese: CP 1 g/m2 i.v. (siegħa), jum 26, 46; Ara-C 75 mg/m2 i.v. (siegħa), jum 28
English: - Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL).
Maltese: - Lewkemija limfoblastika akuta pożittiva għall-kromosomu Philadelphia (Ph+ ALL).
English: Pretreatment with multiple doses of rifampicin 600 mg followed by a single 400 mg dose of imatinib resulted in decrease in Cmax and AUC(0-∞) by at least 54% and 74%, of the respective values without rifampicin treatment.
Maltese: Meta ngħata trattament minn qabel b'numru ta' dożi ta' rifampicin 600 mg li mbagħad kien segwit b'doża waħda ta' imatinib 400 mg, dan irriżulta fi tnaqqis fis-Cmax u fl-AUC(0∞) b'mill-inqas 54% u 74% tal-valuri rispettivi għal meta ma ngħatax rifampicin.
English: 10 film-coated tablets 20 film-coated tablets 30 film-coated tablets 60 film-coated tablets 90 film-coated tablets 120 film-coated tablets 180 film-coated tablets
Maltese: 10 pilloli miksija b'rita 20 pilloli miksija b'rita 30 pilloli miksija b'rita 60 pilloli miksija b'rita 90 pilloli miksija b'rita 120 pilloli miksija b'rita 180 pilloli miksija b'rita
English: Stop imatinib until ANC ≥ 1.5 x 109/L and platelets ≥ 75 x 10
Maltese: Waqqaf imatinib sakemm l-ANC ≥ 1.5 x 109/L u l-plejtlets ≥ 75 x 109/L.
English: Clinical studies in chronic myeloid leukaemia
Maltese: Studji kliniċi fil-lewkimja majelojd kronika
English: L-ASP (6000 IUnits/m2, IM): day 44
Maltese: IUnitajiet/m2, IM): jum 44
English: Renal pain, haematuria, renal failure acute, urinary frequency increased
Maltese: Uġigħ renali, demm fl-awrina, insuffiċjenza renali akuta, żieda fil-frekwenza ta' l-awrina
English: This medicinal product contains lecithin (soya).
Maltese: Dan il-prodott mediċinali fih lecithin (soya).
English: In newly diagnosed chronic phase CML grade 4 neutropenia (ANC < 0.5 x 109/L) and thrombocytopenia (platelet count < 10 x 109/L) were observed in 3.6% and < 1% of patients, respectively.
Maltese: F'CML, fil-fażi l-kronika, li kienet għada kif ġiet dijanjostikata, kien hemm newtropinja tar-4 grad (ANC < 0.5 x 109/L) u tromboċitopenja (għadd tal-plejtlets < 10 x 109/L) f' 3.6% u f' < 1% tal-pazjenti, rispettivament.
English: Periorbital oedema, dermatitis/eczema/rash
Maltese: Edema mad-dawra ta' l-għajnejn, dermatite/ekżema/raxx
English: The pharmacokinetics of imatinib have been evaluated over a dosage range of 25 to 1,000 mg.
Maltese: Il-farmakokinetiċi ta' imatinib Il-farmakokinetiċi ta' imatinib kienu stmati għal dożaġġ li jvarja minn 25 sa 1,000 mg.
English: The age of these patients ranged from 3 months to 4 years and imatinib was given at dose 50 mg daily or doses ranging from 92.5 to 340 mg/m2 daily.
Maltese: L-età ta' dawn il-pazjenti kienet minn 3 xhur sa 4 snin u imatinib ingħata f'doża ta' 50 mg kuljum jew f'dożi li jvarjaw minn 92.5 sa 340 mg/m2 kuljum.
English: Imatinib was administered intermittently in cohorts 1-5, with increasing duration and earlier start of imatinib from cohort to cohort; cohort 1 receiving the lowest intensitiy and cohort 5 receiving the highest intensity of imatinib (longest duration in days with continuous daily imatinib dosing during the first chemotherapy treatment courses).
Maltese: Imatinib ingħata b'mod intermittenti f'koorti ta' 1-5, b'żieda fid-dewmien u bi tnedija bikrija ta' imatinib minn koorti għal koorti; koorti 1 jingħata lanqas intensità u koorti 5 jingħata l-ogħla intensità ta' imatinib (l-iktar dewmien fi ġranet b'dożaġġ ta' imatinib kuljum b'mod kontinwu matul l-ewwel korsijiet ta' trattament b'kimotarapija).
English: Ara-C: cytosine arabinoside; CP: cyclophosphamide; DEX: dexamethasone; MTX: methotrexate; 6-MP: 6-mercaptopurine; VM26: Teniposide; VCR: vincristine; IDA: idarubicine; i.v.
Maltese: cytarabine, CPM = cyclophosphamide, VCR = vincristine, DEX = dexamethasone, DAUN = daunorubicin, 6-MP = 6-mercaptopurine, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG
English: Hyper-CVAD regimen: CP 300 mg/m2 i.v.
Maltese: Reġimen iper-CVAD: CP 300 mg/m2 i.v. (3 siegħat, q 12-il siegħa),
English: The total daily dose in children must not exceed 800 mg with CML and 600 mg with Ph+ALL.
Maltese: Id-doża totali kuljum fit-tfal ma tistax taqbeż it-800 mg f' CML u 600 mg b'Ph+ALL.
English: Imatinib Actavis 100 mg tablets imatinib
Maltese: Imatinib Actavis 100 mg pilloli imatinib
English: Imatinib Actavis 100 mg hard capsules EU/1/13/825/003
Maltese: Imatinib Actavis 100 mg kapsuli iebsin EU/1/13/825/003
English: The results observed in a population of 211 newly diagnosed Ph+ ALL patients in four uncontrolled clinical studies (AAU02, ADE04, AJP01 and AUS01) are consistent with the results described above.
Maltese: f'erba' studji kliniċi mux ikontrollati (AAU02, ADE04, AJP01 u AUS01) huma konsistenti marriżultati deskritti hawn fuq.
English: The dose is 800 mg per day (2 capsules), to be taken as one capsule in the morning and a second capsule in the evening.
Maltese: Id-doża hi 800mg kuljum (2 kapsuli), li jittieħdu bhala kapsula waħda filgħodu u it-tieni kapsula filgħaxija.
English: Dose adjustments for neutropenia and thrombocytopenia:
Maltese: Tibdil fid-doża meta jkun hemm newtropenja u tromboċitopenja:
English: 4 cycles
Maltese: Ċiklu 5
English: Capsule shell Hypromellose Titanium dioxide (E171) Iron oxide yellow (E172)
Maltese: Qoxra tal-kapsula Hypromellose Titanium dioxide (E171) Iron oxide yellow (E172)
English: Methotrexate (5 g/m2 over 24 hours, IV): days 1 and 15 Leucovorin (75 mg/m2 at hour 36, IV; 15 mg/m2 IV or PO q6h x 6 doses)iii:
Maltese: Methotrexate (5 g/m2 fuq medda ta' 24 siegħa, IV): jiem 1 u 15 Leucovorin (75 mg/m2 fis-36 siegħa, IV; 15 mg/m2 IV jew PO q6h x
English: 5 patients responded, 3 completely and 2 partially.
Maltese: Ħames (5) pazjenti urew rispons, 3 komplet u 2 parzjali.
English: Imatinib Actavis is also a treatment for adults for: - Myelodysplastic/myeloproliferative diseases (MDS/MPD).
Maltese: Mard majelodisplastiku/majeloproliferattiv (MDS / MPD).
English: Pharmacokinetics in paediatric population
Maltese: Farmakokinetiċi fil-popolazzjoni pedjatrika
English: The recommended dose of imatinib is 600 mg/day for adult patients with Ph+ ALL.
Maltese: Id-doża rakkomandata ta' imatinib għal pazjenti adulti b'Ph+ALL hija ta' 600 mg/jum.
English: There is very limited experience in children with MDS/MPD, DFSP, and HES/CEL.
Maltese: Hemm esperjenza limitata ħafna dwar l-użu fit-tfal b'MDS/MPD, DFSP, u HES/CEL.
English: Excipients(s)
Maltese: NUMRU(I)
English: Remission induction DEX 10 mg/m2 oral, days 6-7, 13-16; VCR 1 mg i.v., days 7, 14; IDA 8 mg/m2 i.v.
Maltese: DEX 10 mg/m2 orali, jum 6-7, 13-16; VCR 1 mg i.v., jum 7, 14;
English: VCR (1.5 mg/m2/day, IV): days 1, 8, and 15
Maltese: VCR (1.5 mg/m2/kuljum, IV): jiem 1, 8, u 15
English: Paediatric patients: A total of 26 paediatric patients of age < 18 years with either chronic phase CML (n=11) or CML in blast crisis or Ph+ acute leukaemias (n=15) were enrolled in a dose-escalation phase I trial.
Maltese: B'kollox 26-il pazjent pedjatriku ta' età ta' < 18-il sena li jew kellhom CML filfażi l-kronika (n=11) jew kellhom CML fi blast crisis jew lewkimji akuti (n=15) b'Ph+ kienu reklutati fi prova ta' fażi I li fiha d-doża kienet tiżdied.
English: VCR (1.5 mg/m2/day, IV): days 1, 8 and 15
Maltese: VCR (1.5 mg/m2/kuljum, IV): jiem 1, 8 u 15
English: One open label, multicentre, phase II clinical trial (study B2225) was conducted testing imatinib in diverse populations of patients suffering from life-threatening diseases associated with Abl, Kit or PDGFR protein tyrosine kinases.
Maltese: II (studju B2225) kienet imwettaqa billi imatinib kien ittestjat f'popolazzjonijiet diversi ta' pazjenti li jsofru minn mard li jheddu l-ħajja assoċjati ma' Abl, Kit jew PDGFR proteini tyrosine kinases.
English: The overall survival is 65 months since diagnosis (range 25-234).
Maltese: (medda ta' 25-234).
English: 8 to 10 g (single dose): Vomiting and gastrointestinal pain have been reported.
Maltese: 8 sa10 g (doża waħda):
English: - Chronic renal failure.
Maltese: - Insuffiċjenza kronika tal-kliewi.
English: Paediatric patients: In study I2301, a total of 93 paediatric, adolescent and young adult patients (from 1 to 22 years old) with Ph+ ALL were enrolled in an open-label, multicentre, sequential cohort, non-randomised phase III trial, and were treated with imatinib (340 mg/m2/day) in combination with intensive chemotherapy after induction therapy.
Maltese: III open-label, multiċentrika, b'koorti sekwenzjali, mhux randomised, u ngħataw trattament b'imatinib (340 mg/m2/jum) flimkien ma' kimoterapija intensiva wara terapija ta' induzzjoni.
English: Triple IT therapy (age-adjusted): day 1
Maltese: Terapija IT tripla (aġġustata skont l-età): jiem 1 u 15
English: Each tablet contains 100 mg imatinib (as mesilate).
Maltese: Kull pillola fiha 100 mg imatinib (bħal mesilate).
English: Hyperbilirubinaemia, hepatitis, jaundice
Maltese: Iperbilirubinemija, epatite, suffejra
English: Mild to moderate increases in transaminases and slight decreases in cholesterol, triglycerides, total protein and albumin levels were observed in both species.
Maltese: Kien hemm żiediet żgħar għal moderati fil-livelli tat-transaminases u kien hemm xi tnaqqis żgħir fil-livelli tal-kolesterol, tat triglycerides, proteini totali, u ta' l-albumina fiż-żewġ speċi.
English: Actavis Ltd. Tel: +356 21693533
Maltese: Tel: +356 21693533
English: Flushing, haemorrhage
Maltese: Fwawar, emorraġija
English: Posology for DFSP The recommended dose of imatinib is 800 mg/day for adult patients with DFSP.
Maltese: Pożoloġija għal DFSP Id-doża rakkomandata ta' imatinib għal pazjenti adulti b'DFSP hija ta' 800 mg/jum.
English: The starting dose is 600 mg to be taken as one capsule of 400 mg plus 2 capsules of 100 mg once a day.
Maltese: Id-doża tal-bidu tas-soltu hi 600mg li ttieħed bhala kapsula waħda ta' 400 mg u 2 kapsuli ta 100 mg darba kuljum.
English: Maximal plasma concentrations of imatinib in patients are 2-4 μmol/L, consequently an inhibition of CYP2D6 and/or CYP3A4/5-mediated metabolism of co-administered drugs is possible.
Maltese: L-ogħla konċentrazzjonijiet fil-plażma ta' imatinib filpazjenti jvarjaw minn 2-4 µmol/l, u għaldaqstant huwa possibbli li jinibixxi l-metaboliżmu permezz ta' CYP2D6 u/ jew CYP3A4/5 ta' mediċini li jingħataw fl-istess ħin miegħu.
English: The same publication reported long term follow-up data from 12 MDS/MPD patients with PDGFR gene rearrangements (5 patients from study B2225).
Maltese: b'tibdil fil-ġene PDGFR (5 pazjenti minn studju B2225).
English: Neoplasm benign, malignant and unspecified (including cysts and polyps)
Maltese: Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi)
English: Newly diagnosed Ph+ ALL: In a controlled study (ADE10) of imatinib versus chemotherapy induction in 55 newly diagnosed patients aged 55 years and over, imatinib used as single agent induced a significantly higher rate of complete haematological response than chemotherapy (96.3% vs. 50%; p=0.0001).
Maltese: sena ‘l fuq, imatinib użat waħdu wassal għal rispons ematoloġiku komplet b'rata ogħla mill kimoterapija (96.3% vs 50%; p=0.001).
English: Hypertension, haematoma, subdural haematoma, peripheral coldness, hypotension, Raynaud's phenomenon
Maltese: Pressjoni għolja, ematoma, ematoma subdurali, kesħa periferali, pressjoni baxxa, fenomenu ta' Raynaud
English: Each tablet contains 400 mg imatinib (as mesilate).
Maltese: Kull pillola fiha 400 mg imatinib (bħal mesilate).
English: Therefore, caution is recommended when administering imatinib with CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporine, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel and quinidine).
Maltese: sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel u quinidine).
English: The renal adenoma/carcinoma, the urinary bladder and urethra papilloma, the small intestine adenocarcinomas, the parathyroid glands adenomas, the benign and malignant medullary tumours of the adrenal glands and the non-glandular stomach papillomas/carcinomas were noted at 60 mg/kg/day, representing approximately 1.7 or 1 times the human daily exposure (based on AUC) at 400 mg/day or 800 mg/day, respectively, and 1.2 times the daily exposure in children (based on AUC) at 340 mg/m2/day.
Maltese: l-imsaren, l-adenomi tal-glandoli paratajrojd, it-tumuri benini u malinni tal-mudullun tal-glandoli adrenali u tal-papillomi/karċinomi ta' l-istonku mingħajr il-glandoli dehru b'60 mg/kg/jum, li jiġu madwar 1.7-il darba jew darba 1 l-esponiment ta' kuljum fil-bniedem (bażat fuq l-AUC) b'400 mg/jum jew 800 mg/jum, rispettivament, u 1.2-il darba l-esponiment ta' kuljum fit-tfal (bażat fuq l-AUC) b'340 mg/m2/jum.
English: The plasma AUC for imatinib decreased by 73% compared to patients not on EIAEDs.
Maltese: L-AUC fil plażma għal imatinib naqset b'73% meta mqabbla ma pazjenti li ma kienux qed jieħdu EIAED's.
English: Imatinib Actavis 100 mg film-coated tablets EU/1/13/825/008
Maltese: Imatinib Actavis 100 mg pilloli miksija b'rita EU/1/13/825/008
English: Imatinib Actavis 50 mg hard capsules Imatinib Actavis 100 mg hard capsules Imatinib Actavis 400 mg hard capsules
Maltese: Imatinib Actavis 50 mg kapsuli iebsin Imatinib Actavis 100 mg kapsuli iebsin Imatinib Actavis 400 mg kapsuli iebsin
English: Papilloma/carcinoma of the preputial/clitoral gland were noted from 30 mg/kg/day onwards, representing approximately 0.5 or 0.3 times the human daily exposure (based on AUC) at 400 mg/day or 800 mg/day, respectively, and 0.4 times the daily exposure in children (based on AUC) at 340 mg/m2/day.
Maltese: Papilloma/karċinoma tal-glandola tal-prepuzju/klitoris dehru mat-30 mg/kg/jum ‘l quddiem, li jiġi madwar 0.5 jew 0.3-il darba ta' l-esponiment ta' kuljum fil-bniedem (bażat fuq l-AUC) b'400 mg/jum jew 800 mg/jum, rispettivament, u 0.
English: MTX (5 g/m2 over 24 hours, IV): day 1 Leucovorin (75 mg/m2 at hour 36, IV; 15 mg/m2 IV or PO q6h x 6 doses)iii:
Maltese: MTX (5 g/m2 fuq medda ta' 24 siegħa, IV): jum 1 Leucovorin (75 mg/m2 fis-36 siegħa, IV; 15 mg/m2 IV jew PO q6h x 6
English: Capsule shell Hypromellose Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172)
Maltese: Hypromellose Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172)
English: The compound selectively inhibits proliferation and induces apoptosis in Bcr-Abl positive cell lines as well as fresh leukaemic cells from Philadelphia chromosome positive CML and acute lymphoblastic leukaemia (ALL) patients.
Maltese: Din is-sutanza tinpedixxi b'mod selettiv il proliferazzjoni u tistimola apoptożi f'linji ta' ċelluli li jkunu pożittivi għal Bcr-Abl kif ukoll f'ċelluli lewkimiċi friski li jinstabu f'pazjenti li jkollhom CML li tkun pożittiva għall-kromosoma ta' Filadelfja u f'pazjenti b'acute lymphoblastic leukaemia (ALL).
English: The age of these patients ranged from newborn to 14 years and imatinib was given at dose 50 mg daily or doses ranging from 400 to 520 mg/m2 daily.
Maltese: L-età ta' dawn il-pazjenti kienet minn trabi tat-twelid sa 14-il sena u imatinib ingħata f'doża ta'50 mg kuljum jew f'dożi li jvarjaw minn 400 sa 520 mg/m2 kuljum.
English: If anti-ADAMTS13-antibody is elevated in conjunction with low ADAMTS13 activity, treatment with Imatinib Actavis should not be resumed.
Maltese: Jekk antikorp kontra ADAMTS13 jiġi elevat flimkien ma' attività baxxa ta' ADAMTS13, it-trattament b'Imatinib Actavis m'għandux jinbeda millġdid.
English: Imatinib Actavis 400 mg film-coated tablets Pack containing either 10, 30, 60 or 90 film-coated tablets
Maltese: Imatinib Actavis 400 mg pilloli miksija b'rita Pakketti li fihom 10, 30, 60 jew 90 pilloli miksija b'rita.
English: Methotrexate (5 g/m2 over 24 hours, IV): day 1 Leucovorin (75 mg/m2 at hour 36, IV; 15 mg/m2 IV or PO q6h x 6 doses)iii:
Maltese: Methotrexate (5 g/m2 fuq medda ta' 24 siegħa, IV): jum 1 Leucovorin (75 mg/m2 fis-36 siegħa, IV; 15 mg/m2 IV jew PO q6h x
English: Hypersensitivity to soya or peanut.
Maltese: Sensittività eċċessiva għas-soya jew tal-karawett.
English: days 3-5; MTX 15 mg intrathecal, day 1;
Maltese: MTX 15 mg għal ġot-teka l, jum 1;
English: Imatinib Actavis 400 mg film-coated tablets EU/1/13/825/015
Maltese: Imatinib Actavis 400 mg pilloli miksija b'rita EU/1/13/825/015
English: This may be a sign of damage to blood vessels known as thrombotic microangiopathy (TMA).
Maltese: Dawn jistgħu jkunu sinjali ta' ħsara fil-kanali tad-demm magħrufa bħala mikroanġjopatija trombotika (TMA - thrombotic microangiopathy).
English: There was a significant increase in exposure to imatinib (the mean Cmax and AUC of imatinib rose by 26% and 40%, respectively) in healthy subjects when it was co-administered with a single dose of ketoconazole (a CYP3A4 inhibitor).
Maltese: Kien hemm żieda sinifikanti fl-ammont ta' Imatinib esponut (is-Cmax intermedju u l-AUC għal imatinib għolew b'26% u 40% rispettivament) f'persuni f'saħħithom, meta imatinib ingħata flimkien ma' doża waħda ta' ketoconazole (sustanza li tinibixxi sCYP3A4).
English: Tel: +386 15890390
Maltese: Pliva Ljubljana d.o.o. Tel: +386 15890390
English: Pack sizes: The capsules are supplied in aluminium blister packs of 30 or 90 capsules.
Maltese: Il-kapsuli huma fornuti f'pakketti bil-folji tal-aluminju li fihom 30 jew 90 kapsula.
English: Posology for MDS/MPD The recommended dose of imatinib is 400 mg/day for adult patients with MDS/MPD.
Maltese: Id-doża rakkomandata ta' imatinib għal pazjenti adulti b'MDS/MPD hija ta' 400 mg/jum.
English: Three (3) patients with HES and CEL associated with PDGFR gene re-arrangements were reported in 3 publications.
Maltese: Kienu rrappurtati 3 pazjenti b'HES u CEL b'assoċjazzjoni ma' riarranġamenti tal-ġene PDGFR fi 3 pubblikazzjonijiet.
English: Imatinib Actavis is a treatment for:
Maltese: Imatinib Actavis huwa kura għal:
English: Hard capsule of size 00 with orange opaque colour cap and body imprinted with “400 mg” in black ink.
Maltese: Kapsula iebsa ta' daqs 00 b' għatu u korp oranġjo opak mmarkata b' "400 mg" bl-inka sewda.
English: Excipients
Maltese: Epatotossiċità
English: Stomatitis, mouth ulceration, gastrointestinal haemorrhage7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis, dysphagia, pancreatitis
Maltese: Ipokalimija, żieda fl-aptit, ipofosfatemija, nuqqas ta' aptit, deidrazzjoni, gotta, iperuriċemija, iperkalċimija, ipergliċimija, iponatrimija
English: An observational registry (study L2401) was conducted to collect long-term safety and efficacy data in patients suffering from myeloproliferative neoplasms with PDGFR- β rearrangement and who were treated with imatinib.
Maltese: Sar reġistru tal-osservazzjoni (studju L2401) biex tinġabar id-data tas-sikurezza u l-effikaċja fit-tul f'pazjenti li jbatu minn neoplażmi majeloproliferattiv b'arranġament PDGFR- β u li kienu kkurati b'imatinib.
English: Of a panel of potential comedications (acetaminophen, aciclovir, allopurinol, amphotericin, cytarabine, erythromycin, fluconazole, hydroxyurea, norfloxacin, penicillin V) only erythromycin (IC50 50 µM) and fluconazole (IC50 118 µM) showed inhibition of imatinib metabolism which could have clinical relevance.
Maltese: hydroxyurea, norfloxacin, penicillin V), kienu biss erythromycin (IC50 50 µM) u fluconazole (IC50
English: The dose is 800 mg per day (16 capsules), to be taken as 8 capsules in the morning and 8 capsules in the evening.
Maltese: Id-doża hija 800 mg kuljum (16-il kapsula), li għandha tittieħed bħala 8 kapsuli filgħodu u 8 kapsuli filgħaxija.
English: Tablet core
Maltese: Qoxra tal-kapsula