FrancophonIA/ELRC3.0 huggingface dataset:
English: People with known hypersensitivity to maropitant should administer the veterinary medicinal product with caution.
Maltese: Nies li huma sensittivi għal maropitant għandhom jamministraw il-prodott mediċinali veterinarju b'kawtela.
English: Vomiting can be associated with serious, severely debilitating conditions and the cause should be investigated.
Maltese: Ir-remettar jista' jkun assoċjat ma' kondizzjonijiet serji debilitanti severament u l-kawża għandha tiġi investigata.
English: PHARMACEUTICAL FORM Solution for injection A clear, colourless to light yellow solution
Maltese: GĦAMLA FARMAĊEWTIKA Soluzzjoni għall-injezzjoni
English: No data have been presented on overdoses in adult cats.
Maltese: L-ebda data ma ġiet ippreżentata dwar dożi eċċessivi fi qtates adulti.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Prevomax 10 mg/ml solution for injection for dogs and cats
Maltese: VETERINARJU Prevomax 10 mg/ml soluzzjoni għall-injezzjoni għall-klieb u l-qtates
English: For administration by subcutaneous injection, see also “special precautions for use in animals” (section 4.5).
Maltese: Għal għoti b'injezzjoni taħt il-ġilda, ara wkoll “prekawzjonijiet speċjali għall-użu fl-annimali” (sezzjoni 4.5).
English: Maropitant has been shown to be a potential eye irritant, and in the case of accidental eye exposure, flush the eyes with plenty of water and seek medical attention.
Maltese: Maropitant ntwera li huwa irritant tal għajnejn potenzjali, u f'każ li tesponi għajnejk b'mod aċċidentali, laħlaħ għajnejk b'ħafna ilma u fittexattenzjoni medika.
English: Maropitant is metabolised in the liver and therefore should be used with caution in dogs and cats with liver disease.
Maltese: Maropitant jiġi metabolizzat fil-fwied u għaldaqstant għandu jintuża b'kawtela f'pazjenti b'mard epatiku.
English: Increases of approximately 10% in the QT interval of the ECG were observed in a study on healthy Beagle dogs administered 8 mg/kg orally; however, such an increase is unlikely to be of clinical significance.
Maltese: Il-prodott mediċinali veterinarju għandu jintuża b'kawtela f'annimali li jsofru minn jew bi predispożizzjoni għal mard tal-qalb peress li maropitant għandu affinità mal-kanali Ca- u K-ion. Fi studju fuq klieb Beagle b'saħħithom li ngħataw 8 mg/kg mill-ħalq, ġew osservati żidiet ta' madwar 10 % fl-intervall tal-QT tal-ECG; madankollu, tali żieda aktarx m'għandhiex sinifikanza klinika.
English: The veterinary medicinal product should be used with caution in animals suffering from or with predisposition for cardiac diseases as maropitant has affinity to Ca- and K-ion channels.
Maltese: Kwalunkwe prodott mediċinali veterinarju li ma ġiex użat jew materjal għar-rimi li huwa derivat minn dan il-prodott mediċinali veterinarju għandhom jintremew skont kif jitolbu r-rekwiżiti tal-pajjiż.
English: PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: Antiemetics.
Maltese: KWALITAJIET FARMAKOLOĠIĊI
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Maltese: Rekwiżiti speċifiċi ta' farmakoviġilanza:
English: Prilaz baruna Filipovica 25 10000 Zagreb
Maltese: Prilaz baruna Filipovica 25 10000
English: Imatinib vs placebo
Maltese: Imatinib vs plaċebo
English: - Gastrointestinal stromal tumours (GIST).
Maltese: (GIST: Gastrointestinal Stromal Tumours).
English: All doses (n=147) 400 mg (n=73) 600 mg (n=74) n (%)
Maltese: 400 mg (n=73) 600 mg (n=74)
English: TEVA Pharmaceutical Works Private Limited Company
Maltese: Teva Pharmaceutical Works Private Limited Company Pallagi út 13
English: Teva Pharmaceuticals Ireland, L-Irlanda Tel: +353 51 321740
Maltese: Teva Pharmaceuticals Ireland Tel: +353 51 321740
English: Teva Pharmaceuticals Polska Sp. z o.o.
Maltese: Teva Operations Poland Sp. z o.o. ul.
English: Brampton Road, Hampden Park, Eastbourne, East Sussex,
Maltese: Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG
English: - The tablet coating is made of polyvinyl alcohol partially hydrolysed, macrogol, iron oxide yellow
Maltese: Polyvinyl alcohol partially hydrolysed Macrogol
English: Ara-C 60 mg/m2 i.v., days 22-25, 29-32
Maltese: Ara-C 60 mg/m2 i.v., jum 22-25, 29-32
English: Total bilirubin: >3-10 ULN AST: any
Maltese: Bilirubin totali: >3-10 ULN
English: Overall hazard ratio (95% CI)*
Maltese: Proporzjon globali ta' periklu (95%CI)*
English: The length of the capsule is from 19.1 mm to 19.7 mm and the width is 6.91 mm.
Maltese: It-tul tal-kapsula huwa minn 19.1 mm għal 19.7 mm u l-wisa' hija 6.91 mm.
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: Tlf: +47 66 77 55 90
Maltese: Teva Norway AS Tlf: +47 66 77 55 90
English: Mitotic index data were available for 556 of the 713 intention-to-treat (ITT) population.
Maltese: Data dwar indiċi mitotiċi kienet disponibbli għal 556 mill-popolazzjoni ta' 713-il pazjent ta' intenzjoni li tikkura (ITT).
English: The length of the capsule is from 23.0 mm to 23.6 mm and the width is 8.53 mm.
Maltese: It-tul tal-kapsula huwa minn 23.0 mm sa 23.6 mm u l-wisa 'hija 8.53 mm.
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: platelets < 10 x 109/l
Maltese: plejtelets < 10 x 109/L
English: At one year the overall RFS was significantly better for imatinib (97.7%) vs. placebo (82.3%), (p<0.0001).
Maltese: Wara sena l-RFS globali kien aħjar b'mod sinifikanti għal imatinib (97.7%) vs. plaċebo (82.3%), (p<0.0001).
English: days 3-5;
Maltese: jum 1-3;
English: Table 1 Tabulated summary of adverse reactions
Maltese: Tabella 1 Sommarju f'tabella ta' reazzjonijiet avversi
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: VCR 1 mg i.v., days 7, 14;
Maltese: VCR 1 mg i.v., jum 7, 14;
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 nqisu b'mod konservattiv li l pazjenti b'data nieqsa kienu pazjenti li ma rrispondewx, is-CHR kien osservat f'20/23 (87%) pazjent, isCCyR f'9/23 (39.1%) pazjent, u l-MR fi 11/23 (47.8%) pazjent, rispettivament.
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 fil-creatine phosphokinase, żieda fil-bilirubin, uġigħ gastrointestinali.
English: Table 5 Best tumour response in trial STIB2222 (GIST)
Maltese: L-aqwa rispons tat-tumur fil-prova STIB2222 (GIST)
English: (Confirmed3) [95% CI] Partial
Maltese: Komplet (Konfermati3) [95% CI]
English: Mitoxantrone 10 mg/m2 i.v.
Maltese: Mitoxantrone 10 mg/m2 i.v. jum 3-5;
English: The printing ink is composed of shellac, iron oxide black (E172) and propylene glycol.
Maltese: L-inka hija magħmula minn shellac, iron oxide black (E172) and propylene glycol.
English: Not known (frequency cannot be estimated from the available data):
Maltese: Mhux magħruf (frekwenza ma tistax tiġi stmata mid-data disponibbli):
English: Vindesine 3 mg/m2 i.v., day 1;
Maltese: Vindesine 3 mg/m2 i.v., jum 1;
English: Daunorubicin 30 mg/m2 i.v., days 1-3, 15-16;
Maltese: Daunorubicin 30 mg/m2 i.v., jum 1-3, 15-16;
English: Table 7 12-month and 36-month imatinib treatment (SSGXVIII/AIO Trial)
Maltese: Tabella7 Trattament ta' 12-il xahar u 36 xahar bi imatinib (Prova SSGXVIII/AIO)
English: Posology for Ph+ ALL in adult patients
Maltese: Pożoloġija għall-Ph+ ALL f' pazjenti adulti
English: • Adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement.
Maltese: • Pazjenti adulti li jkollhom sindrome ipereżinofilika avvanzata (HES) u/jew lewkimja kronika eżinofolika (CEL) b'tibdil FIP1L1-PDGFRα.
English: VCR 2 mg i.v., days 6, 13, 20;
Maltese: VCR 2 mg i.v., jum 6, 13, 20;
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 il-biotrasformazzjoni ta' 5-fluoruracil, iżda inibixxa l-metaboliżmu ta' paclitaxel billi inibixxa b'mod kompetittiv lill-CYP2C8 (Ki=34.7 μM).
English: (starting dose 340 mg/m2)
Maltese: • (doża tal bidu 340 mg/m
English: Table 6 Summary of Z9001 trial RFS analyses by NIH and AFIP risk classifications
Maltese: Tabella 6 Sommarju tal-prova Z9001 tal-analiżi ta' RFS permezz tal-klassifikazzjonijiet tarriskju NIH u AFIP
English: - Myelodysplastic/myeloproliferative diseases (MDS/MPD).
Maltese: • Mard majelodisplastiku/majeloproliferattiv (MDS/MPD).
English: 18 Gy in 10 fractions for patients that are CNS3 at diagnosis
Maltese: 18 Gy f'10 frazzjonijiet għal pazjenti li huma CNS3 waqt id dijanjosi
English: The Kaplan-Meier estimate for survival after 36-month follow-up is 68%.
Maltese: L-istima tas-sopravivenza Kaplan-Meier wara 36-xahar ta' follow-up hija 68%.
English: Imatinib Teva B.V. is a treatment for: - Chronic myeloid leukaemia (CML).
Maltese: Imatinib Teva B.V. huwa kura għall-: - Lewkimja majelojd kronika (chronic myeloid leukaemia (CML)).
English: MTX 15 mg intrathecal, day 1; Methylprednisolone 40 mg intrathecal, day 1
Maltese: MTX 15 mg għal ġot-teka l, jum 1; Methylprednisolone 40 mg għal ġot-teka, jum 1
English: Daunorubicin 45 mg/m2 i.v., days 6-7, 13-14
Maltese: Daunorubicin 45 mg/m2 i.v., jum 6-7, 13-14
English: Mean absolute bioavailability for the capsule formulation is 98%.
Maltese: Il-biodisponibiltà assoluta medja għall-formulazzjoni f'għamla ta' kapsula hija ta' 98%.
English: Study 0102 38-month data Myeloid blast crisis (n=260)
Maltese: Studju 0102 Dejta ta' 38 xahar Majelojd blast crisis
English: • Adult patients with Ph+ CML in blast crisis.
Maltese: - Pazjenti adulti b'Ph+ CML li jkunu fi blast crisis.
English: DEX 10 mg/m2 oral, days 6-7, 13-16;
Maltese: DEX 10 mg/m2 orali, jum 6-7, 13-16;
English: VCR 2 mg total dose i.v., days 1, 8, 15, 22; CP 750 mg/m2 i.v., days 1, 8;
Maltese: VCR 2 mg dosa totali i.v., jum 1, 8, 15, 22; CP 750 mg/m2 i.v., jum 1, 8;
English: Confusional state Nervous system disorders Very common:
Maltese: Stat konfużjonali Disturbi fis-sistema nervuża Komuni ħafna
English: Thirty-six (36) months of imatinib treatment significantly prolonged RFS compared to 12 months of imatinib treatment (with overall Hazard Ratio (HR) = 0.46 [0.32, 0.65], p<0.0001) (Table 7, Figure 1).
Maltese: Sitta u tletin (36) xahar ta' kura bi imatinib tawlet b'mod sinifikanti l-RFS imqabbel mat-12-il xahar ta' trattament bi imatinib (bil-proporzjoni totali ta' periklu (HR) = 0.46 [0.32, 0.65], p<0.0001) (Tabella 7, Figura 1).
English: 100 vs. 98.7 100 vs. 95.5 0.59 (0.17; 2.10) 100 vs. 94.8 97.8 vs. 89.5 44.8 21/140 vs. 51/127 0.29 (0.18; 0.49) 94.8 vs. 64.0 80.7 vs. 46.6 N.E.
Maltese: 44.8 21/140 vs. 51/127 0.29 (0.18; 0.49) 94.8 vs. 64.0 80.
English: Pharmacotherapeutic group: Protein kinase inhibitors, ATC code: L01XE01
Maltese: Aġenti anti-neoplastiċi, inibitur tal-proteina kinase, Kodiċi ATC:
English: DEX 10 mg/m2 oral, days 1-5;
Maltese: DEX 10 mg/m2 orali, jum 1-5;
English: - Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL).
Maltese: • Sindrome ipereżinofilika (HES) u/jew Lewkimja eżinofilika kronika (CEL).
English: (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: <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: Methylprednisolone 40 mg intrathecal, days 1, 8, 15, 22
Maltese: Methylprednisolone 40 mg għal ġot-teka, jum 1, 8, 15, 22
English: See section 4
Maltese: Tabella 5
English: 0.16 (0.03; 0.70) 97.9 vs. 90.8 97.9 vs. 73.3 0.27 (0.15; 0.48) 98.7 vs. 56.1 79.9 vs. 41.5
Maltese: 0.27 (0.15; 0.48) 98.7 vs. 56.1 79.9 vs.
English: Imatinib and the N-demethyl metabolite together accounted for about 65% of the circulating radioactivity (AUC(0-48h)).
Maltese: Imatinib u l-metabolu N-demethyl flimkien kienu jgħoddu għal xi 65% tar-radjuattività fiċ-ċirkolazzjoni (AUC(0-48h)).
English: Paediatric accelerated phase CML and blast crisis (starting dose 340 mg/m2)
Maltese: CML fil-fażi aċċelerata pedjatrika u blast crisis (doża tal-bidu 340 mg/m2)
English: Methotrexate (20 mg/m2/week, PO): days 8, 15, 22, 29, 36, 43, 50
Maltese: Methotrexate (20 mg/m2/ġimgħa, PO): jiem 8, 15, 22, 29, 36, 43,
English: The median time of follow-up was 54 months (from date of randomisation to data cut-off), with a total of 83 months between the first patient randomised and the cut-off date.
Maltese: 54 xahar (mid-data ta' randomizzazzjoni sad-data tat-twaqqif), b'total ta' 83 xahar bejn l-ewwel pazjent randomizzat u d-data tat-twaqqif.
English: Population pharmacokinetics
Maltese: Effetti farmakodinamiċi
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
Maltese: (acetaminophen, aciclovir, allopurinol, amphoteracin, cytarabine, erythromycin, fluconazole, hydroxyurea, norfloxacin, penicillin V), kienu biss erythromycin (IC50 50 μM) u fluconazole (IC50 118 μM) li inibixxew il metaboliżmu ta' imatinib b'mod li seta' kellu xi relevanza klinika.
English: EU/1/17/1243/001 20x1 film-coated tablets EU/1/17/1243/002 60 film-coated tablets EU/1/17/1243/003 60x1 film-coated tablets EU/1/17/1243/004 120 film-coated tablets EU/1/17/1243/005 120x1 film-coated tablets EU/1/17/1243/006 180x1 film-coated tablets EU/1/17/1243/007 20x1 film-coated tablets EU/1/17/1243/008 60 film-coated tablets EU/1/17/1243/009 60x1 film-coated tablets EU/1/17/1243/010 120 film-coated tablets EU/1/17/1243/011 120x1 film-coated tablets EU/1/17/1243/012 180x1 film-coated tablets imatinib teva b.v. 100 mg film-coated tablets
Maltese: EU/1/17/1243/001 20x1 pilloli miksijin b'rita EU/1/17/1243/002 60 pilloli miksijin b'rita EU/1/17/1243/003 60x1 pilloli miksijin b'rita EU/1/17/1243/004 120 pilloli miksijin b'rita EU/1/17/1243/005 120x1 pilloli miksijin b'rita EU/1/17/1243/006 180x1 pilloli miksijin b'rita EU/1/17/1243/007 20x1 pilloli miksijin b'rita EU/1/17/1243/008 60 pilloli miksijin b'rita EU/1/17/1243/009 60x1 pilloli miksijin b'rita EU/1/17/1243/010 120 pilloli miksijin b'rita EU/1/17/1243/011 120x1 pilloli miksijin b'rita EU/1/17/1243/012 180x1 pilloli miksijin b'rita
English: Pack sizes of 20x1, 60x1, 120x1 or 180x1 hard capsules in perforated unit dose blisters.
Maltese: Pakketti ta' 20x1, 60x1, 120x1 or 180x1 kapsuli iebsin f' ‘perforated unit dose blisters'.
English: This is because Imatinib Teva B.V.
Maltese: Tiħux Imatinib Teva B.V.
English: AST: >ULN (can be normal or < ULN if total bilirubin is > ULN)
Maltese: >ULN (jista' jkun normali jew <ULN il-bilirubin totali jkun >ULN)
English: Other medicines and Imatinib Teva B.V.
Maltese: Mediċini oħra u Imatinib Teva B.V.
English: (q
Maltese: (CHR)
English: Common:
Maltese: AST:
English: Non transparent orange capsules with black marking 7629 on capsule body and black marking TEVA on capsule cap.
Maltese: Kapsuli oranġjo mhux trasparenti b'marka sewda 7629 fuq il-korp tal-kapsula u TEVA immarkata sewda fuq għatu tal-kapsula.
English: dysphagia, pancreatitis
Maltese: Katarretti, glawkoma, papilledema
English: (E172), talc, titanium dioxide (E171) and iron oxide red (E172))
Maltese: Titanium dioxide (E171) Iron oxide red (E172)
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)* Disturbi fil-fwied u fil-marrara
English: i.v.
Maltese: B.V.
English: MTX 12 mg intrathecal, day 1
Maltese: MTX 12 mg għal ġot-teka, jum 1
English: Methotrexate (20 mg/m2/week, PO): days 8, 15, 22
Maltese: Methotrexate (20 mg/m2/ġimgħa, PO): jiem 8, 15, 22
English: Iron oxide black (E172)
Maltese: Iron oxide yellow (E172) Talc
English: Imatinib was shown in vitro to be a competitive inhibitor of marker substrates for CYP2C9, CYP2D6 and CYP3A4/5.
Maltese: Ir-riżultati in vitro wrew li imatinib jinibixxi b'mod kompetittiv lis-sustanzi markaturi li fuqhom jaħdmu lenzimi CYP2C9, CYP2D6 u CYP3A4/5.
English: EU/1/17/1243/025 30 film-coated tablets EU/1/17/1243/026 30x1 film-coated tablets EU/1/17/1243/027 90 film-coated tablets EU/1/17/1243/028 90x1 film-coated tablets EU/1/17/1243/029 30 film-coated tablets EU/1/17/1243/030 30x1 film-coated tablets EU/1/17/1243/031 90 film-coated tablets EU/1/17/1243/032 90x1 film-coated tablets imatinib teva b.v. 400 mg film-coated tablets
Maltese: EU/1/17/1243/025 30 pillola miksija b'rita EU/1/17/1243/026 30x1 pillola miksija b'rita EU/1/17/1243/027 90 pillola miksija b'rita EU/1/17/1243/028 90x1 pillola miksija b'rita EU/1/17/1243/029 30 pillola miksija b'rita EU/1/17/1243/030 30x1 pillola miksija b'rita EU/1/17/1243/031 90 pillola miksija b'rita EU/1/17/1243/032 90x1 pillola miksija b'rita
English: Liver function tests
Maltese: Testijiet tal-laboratorju
English: Stop imatinib until ANC ≥ 1.5 x 109/l and platelets ≥ 75 x 109/l.
Maltese: Waqqaf imatinib sakemm ANC ≥ 1.5 x 109/L u plejtlets ≥ 75 x 109/L.
English: Based on preliminary population pharmacokinetic analysis in GIST patients, there were three variables (albumin, WBC and bilirubin) found to have a statistically significant relationship with imatinib pharmacokinetics.
Maltese: Skond analiżi farmakokinetika preliminari tal-popolazzjoni f' pazjenti b'GIST, jidher li kien hemm tlett varjanti (albumina, WBC, u bilirubin) li kellhom relazzjoni mal farmakokinetiċi ta' imatinib li kienet statistikament sinifikanti.
English: Clinical studies in DFSP
Maltese: Pożoloġija għal DFSP
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 = 6mercaptopurine, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2mercaptoethane sulfonate sodium, iii= or until MTX level is < 0.1 µM, q6h = every 6 hours, Gy= Gray
Maltese: cyclophosphamide, VCR = vincristine, DEX = dexamethasone, DAUN = daunorubicin, 6-MP = 6mercaptopurine, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2mercaptoethane sulfonate sodium, iii= jew sa meta l-livell MTX ikun < 0.1 μM, q6h = kull 6 sigħat, Gy= Gray
English: Immunohistochemistry was routinely performed with Kit antibody (A-4502, rabbit polyclonal antiserum, 1:100; DAKO Corporation, Carpinteria, CA) according to analysis by an avidin-biotin-peroxidase complex method after antigen retrieval.
Maltese: Bħala rutina, kienu dejjem isiru testijiet ta' l immunoistokimika b'anti-korpi Kit (A-4502, anti-serum poliklonali tal-fenek, 1;100; Korporazzjoni DAKO,
English: (1 h), days 28-31, 35-38, 42-45; 6-MP 60 mg/m2 oral, days 26-46
Maltese: Ara-C 75 mg/m2 i.v. (siegħa), jum 28-31, 35-38, 42-45; 6-MP 60 mg/m2 orali, jum 26-46
English: - The other ingredients are calcium hydrogen phosphate anhydrous, crospovidone and magnesium stearate.
Maltese: Calcium hydrogen phosphate, anhydrous Crospovidone
English: Imatinib is a small molecule protein-tyrosine kinase inhibitor that potently inhibits the activity of the Bcr-Abl tyrosine kinase (TK), as well as several receptor TKs: Kit, the receptor for stem cell factor (SCF) coded for by the c-Kit proto-oncogene, the discoidin domain receptors (DDR1 and DDR2), the colony stimulating factor receptor (CSF-1R) and the platelet-derived growth factor receptors alpha and beta (PDGFR-alpha and PDGFR-beta).
Maltese: kkodifikat bis-c-Kit proto-oncogene, id-discoidin domain receptors (DDR1 u DDR2), il-colony stimulating factor receptor (CSF-1R) u l-platelet-derived growth factor receptors alpha u beta (PDGFR-alpha u
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/ connective tissue/vaskulari, u gastro-intestinali.
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,
English: % of patients (CI95%)
Maltese: (n=260) % tal-pazjenti (CI95%)
English: Non transparent orange capsules with black marking 7630 on capsule body and black marking TEVA on capsule cap.
Maltese: Kapsuli oranġjo mhux trasparenti b'marka sewda 7630 fuq il-korp tal-kapsula u TEVA immarkata sewda fuq għatu tal-kapsula.
English: Some side effects may be serious.
Maltese: Effetti sekondarji possibbli
English: At clinically relevant concentrations of imatinib, binding to plasma proteins was approximately 95% on the basis of in vitro experiments, mostly to albumin and alpha-acid-glycoprotein, with little binding to lipoprotein.
Maltese: 95% bażati fuq esperimenti li saru in vitro, l-aktar ma' l-albumina u ma' alpha acid glycoprotein, bi ftit li xejn irbit mal-lipoprotein.
English: Treatment was discontinued permanently because of liver laboratory abnormalities in less than 1% of CML patients.
Maltese: minħabba abnormalitajiet fit-testijiet tal-laboratorju fuq il-funzjoni tal-fwied, f'inqas minn 1% tal-pazjenti b'CML.
English: The capsule shell is composed of gelatin, titanium dioxide (E171), iron oxide yellow (E172) and iron oxide red (E172).
Maltese: Titanium dioxide (E171) Iron oxide, yellow (E172) Iron oxide, red (E172)
English: DEX 10 mg/m2 oral, days 1-5; CP 200 mg/m2 i.v., days 3, 4, 5;
Maltese: DEX 10 mg/m2 orali, jum 1-5; CP 200 mg/m2 i.v., jum 3, 4, 5;
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: Fil-kbar id-doża għandha titnaqqas minn 400 mg għal 300 mg jew inkella minn 600 mg għal 400 mg, jew minn 800 mg għal 600 mg, u fit-tfal minn 340 għal 260 mg/m2/jum.
English: The plasma AUC for this metabolite was found to be only 16% of the AUC for imatinib.
Maltese: L-AUC tal-plażma għal dan il-metabolu kienet biss 16% ta' l-AUC għal imatinib.
English: Patients were treated with imatinib 340 mg/m2/day, with no interruptions in the absence of dose limiting toxicity.
Maltese: Ilpazjenti kienu kurati b'imatinib 340 mg/m2/jum, mingħajr interuzzjonijiet jekk ma jkunx hemm tossiċita li tillimita d-doża.
English: MESNA (360 mg/m2/dose q3h, x 8 doses/day, IV): days 1-5 G-CSF (5 μg/kg, SC): days 6-15 or until ANC > 1500 post nadir IT Methotrexate (age-adjusted): day 1 ONLY Triple IT therapy (age-adjusted): day 8, 15
Maltese: MESNA (360 mg/m2/doża q3h, x 8 dożi/kuljum, IV): jiem 1-5 G-CSF (5 μg/kg, SC): jiem 6-15 jew sa ANC > 1500 postnadir
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates 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 il-prodott jiġi inkluż fil-lista ta 'dati ta' referenza tal-Unjoni (lista EURD) previsti taħt l-Artikolu 107c (7) tad-Direttiva 2001/83/EC u pubblikata fuq il-web-portal tal-mediċini tal-Ewropa.