FrancophonIA/ELRC3.0 huggingface dataset:
English: • Information that atypical/opportunistic infections, and in particular PML, may occur with TYSABRI and include: o That the risk of PML increases with increasing duration of treatment and that treatment beyond 24 months carries additional risk o Other factors associated with an increased risk for the development of PML Immunosuppressant treatment prior to the use of Tysabri Presence of anti-JC virus antibodies o A stratification of the risk of developing PML based on the three identified risk factors o Diagnosis of PML including differentiation between PML and MS relapse o PML management algorithm o Possibility of other opportunistic infections o The recommendation that patients should have MRI scans at the following times Within 3 months prior to starting TYSABRI Annually during treatment with TYSABRIi At the first sign of any symptoms indicative of the possibility of PML.
Maltese: • Informazzjoni li infezzjonijiet mhux tipiċi/opportunistiċi, b'mod partikolari PML, jistgħu jseħħu b'TYSABRI inkluż: o Li r-riskju ta' PML jiżdied hekk kif jiżdied it-tul ta' kura u li kura ta' aktar minn 24
English: The Member States shall discuss and agree the physician pack with the MAH and ensure that:
Maltese: MEMBRI l-Awtoritajiet Kompetenti Nazzjonali f'kull Stat Membru għandhom jiddiskutu u jiftiehmu mad
English: The physician information about TYSABRI shall contain the following key elements:
Maltese: L-informazzjoni għat-tobba dwar TYSABRI irid ikollha dawn l-elementi prinċipali li ġejjin:
English: A copy of the treatment initiation form A patient alert card including a core text agreed by the CHMP o If treatment is to be continued for longer than 24 months, the need to inform patients about the increased risk of PML and provide them with a copy of the treatment continuation form o The need to inform the National Competent Authority about any cases of PML
Maltese: kontinwazzjoni tal-kura o Il-ħtieġa li l-Awtorità Kompetenti Nazzjonali jiġu informati dwar kull każ ta' PML
English: The National Competent Authorities in each Member State shall discuss and agree with the Marketing Authorisation Holder (MAH ) measures to enhance further the monitoring of patients treated with Tysabri (e.g. registries, post-marketing surveillance studies) as appropriate and must ensure that the MAH implements the agreed measures within an agreed time frame.
Maltese: Detentur ta' l-Awtorizzazzjoni għat-tqegħid fis-Suq (MAH) dwar miżuri biex itejbu aktar issorveljanza ta' pazjenti kkurati b'Tysabri (eż. reġistri, studji ta' sorveljanza wara t-tqegħid fis-suq) kif jixraq u għandhom jiżguraw li l-MAH jimplimenta l-miżuri mifthiema għas-sorveljanza fiż-żmien miftiehem.
English: Further information on Semintra can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The target SBP is between 120 and 140 mmHg.
Maltese: Is-SBP fil-mira hija bejn 120 u 140 mmHg.
English: This overview was last updated in March 2018.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f' Marzu 2018.
English: Semintra received a marketing authorisation valid throughout the EU, on 13 February 2013.
Maltese: Semintra rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha, fit-13 ta' Frar 2013.
English: In a second field study involving 294 cats with hypertension with average age 13 years, 194 cats given Semintra once a day for 28 days had a reduction of SBP of 25 mmHg at day 28 compared to 11 mmHg for 100 cats given placebo (a dummy treatment).
Maltese: Fit-tieni studju fuq il-post li involva 294 qattus b'ipertensjoni b'età medja ta' 13-il sena, 194 qattus li ngħataw Semintra darba kuljum għal 28 jum kellhom tnaqqis tas-SBP ta' 25 mmHg f'jum 28 meta mqabbel ma' 11 mmHg għal 100 qattus li ngħataw plaċebo (kura finta).
English: Two different strengths are available: 4 mg/ml to reduce proteinuria and 10 mg/ml to treat high blood pressure.
Maltese: Hemm disponibbli żewġ qawwiet differenti: 4 mg/ml biex tnaqqas il-proteinurja u 10 mg/ml biex tikkura pressjoni tad-demm għolja.
English: What are the risks associated with Semintra?
Maltese: X'inhuma r-riskji assoċjati ma' Semintra?
English: Other information about Semintra:
Maltese: Informazzjoni oħra dwar Semintra
English: The recommended dose to reduce proteinuria is 1 mg telmisartan per kg bodyweight.
Maltese: Id-doża rrakkomandata biex titnaqqas il-proteinurja hija 1 mg telmisartan għal kull kg talpiż tal-ġisem.
English: After 4 weeks the dose can be reduced in cats with systolic blood pressure (SBP) of less than 140 mmHg.
Maltese: Wara 4 ġimgħat, id-doża tista' titnaqqas fi qtates bi pressjoni tad-demm sistolika (SBP, systolic blood pressure) ta' inqas minn 140 mmHg.
English: In a field study involving 224 cats with chronic kidney disease, aged mainly over 11 years, Semintra was as effective as benazepril, another veterinary medicine used to reduce proteinuria, in reducing proteinuria.
Maltese: Fi studju fuq il-post li involva 224 qattus b'marda tal-kliewi kronika, li prinċipalment kellhom aktar minn 11-il sena, Semintra kien effettiv daqs benazepril, mediċina veterinarja oħra li tintuża biex
English: At the end of the 28 days Semintra treated cats continued to be treated for an additional 92 days and these cats had a reduction of SBP of more than 20 mmHg for the entire 4 month study period.
Maltese: Fl-aħħar tat-28 jum, il-qtates ikkurati b'Semintra baqgħu jiġu kkurati għal 92 jum addizzjonali u dawn il-qtates kellhom tnaqqis tasSBP ta' aktar minn 20 mmHg għall-perjodu ta' studju sħiħ ta' 4 xhur.
English: Proteinuria can occur with chronic (long-term) kidney disease in cats, a common disease in elderly cats characterised by a progressive deterioration of kidney function over time.
Maltese: Il-proteinurja tista' sseħħ ma' marda tal-kliewi kronika (fit-tul) fil-qtates, marda komuni fi qtates kbar fl-età kkaratterizzata minn deterjorazzjoni progressiva talfunzjoni tal-kliewi maż-żmien.
English: Semintra is a veterinary medicine used in cats to reduce proteinuria (protein in the urine) and to treat high blood pressure.
Maltese: Semintra hija mediċina veterinarja li tintuża fil-qtates biex tnaqqas il-proteinurja (proteina fl-awrina) u biex tikkura pressjoni tad-demm għolja.
English: The most common side effects seen with Semintra are mild and short-lived vomiting and diarrhoea (which may affect up to 1 in 10 cats treated with the 10 mg/ml strength solution).
Maltese: L-effetti sekondarji l-aktar komuni li dehru b'Semintra huma rimettar u dijarea ħfief u li ma jdumux (li jistgħu jaffettwaw sa 1 minn kull 10 qtates ikkurati bis-soluzzjoni ta' qawwa ta' 10 mg/ml).
English: High blood pressure is also a long term problem of ageing cats which can occur with chronic kidney disease, hyperthyroidism (overactive thyroid gland) and other conditions.
Maltese: Pressjoni tad-demm għolja hija wkoll problema fit-tul ta' qtates li qed jikbru li tista' sseħħ ma' marda tal-kliewi kronika, ipertirojdiżmu (glandola tat-tirojde attiva żżejjed) u kondizzjonijiet oħra.
English: Why is Semintra authorised in the EU?
Maltese: Għalfejn Semintra huwa awtorizzat fl-UE?
English: The active substance in Semintra, telmisartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Maltese: Is-sustanza attiva f'Semintra, telmisartan, hija “antagonista tar-riċettur ta' anġjotensina
English: To treat high blood pressure an initial dose of 2 mg telmisartan per kg bodyweight is used.
Maltese: Sabiex tiġi kkurata pressjoni tad-demm għolja, tintuża doża inizjali ta' 2 mg telmisartan għal kull kg tal-piż tal-ġisem.
English: How is Semintra used?
Maltese: Kif jintuża Semintra?
English: This allows blood pressure to drop with a resulting decrease in protein in the urine which may slow down progression of kidney disease.
Maltese: tnaqqas il-proteinurja, fit-tnaqqis tal-proteinurja.
English: For a full list of all side effects reported with Semintra, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Semintra, ara l-fuljett ta' tagħrif.
English: How does Semintra work?
Maltese: Kif jaħdem Semintra?
English: At risk : Events
Maltese: F'riskju : Episodji
English: dihydroergotamine).
Maltese: (ergotamine, dihydroergotamine).
English: Table 6 Kinase profile of nilotinib (phosphorylation IC50 nM)
Maltese: Tabella 6 Profil kinase ta' nilotinib (fosforilazzjoni IC50 nM)
English: Date of first authorisation: 19 November 2007 Date of latest renewal: 19 November 2012
Maltese: Data tal-aħħar tiġdid: 19 ta' Novembru 2012
English: Total gastrectomy
Maltese: Gastrektomija totali
English: Figure 1 Cumulative incidence of MMR
Maltese: Figura 1 Inċidenza akkumulattiva ta' MMR
English: Final CSR: April 2021
Maltese: April 2021
English: <1 Common
Maltese: <1 Komuni
English: Cumulative incidence of MMR, %
Maltese: Inċidenza kumulattiva ta'MMR, %
English: Rifampicin, a potent CYP3A4 inducer, decreases nilotinib Cmax by 64% and reduces nilotinib AUC by 80%.
Maltese: Rifampicin, induttur CYP3A4 potenti, inaqqas nilotinib Cmax b'64% u inaqqas nilotinib AUC b'80%.
English: Body Surface Area (BSA)
Maltese: Area tas-Superfiċi tal-Ġisem (BSA)
English: Grade
Maltese: Gradi
English: By 5 years
Maltese: Sa 5 snin
English: Similar events were observed in post-marketing reports.
Maltese: Kienu osservati episodji simili miġbura f'rapporti wara t-tqegħid tal-prodott fis-suq.
English: Intoleran t (n=95)
Maltese: Intollera nti (n=95)
English: Response (95% CI) No response
Maltese: Risponse (95% CI)
English: In vitro, nilotinib is a relatively strong inhibitor of CYP3A4, CYP2C8, CYP2C9, CYP2D6 and UGT1A1, with Ki value being lowest for CYP2C9 (Ki=0.13 microM).
Maltese: In vitro, nilotinib huwa inibitur relattivament qawwi ta' CYP3A4, CYP2C8, CYP2C9, CYP2D6 and UGT1A1, bil-valur ta' Ki fost l-aktar baxxi għal CYP2C9 (Ki=0.
English: Intoleran t (n=27)
Maltese: Intollera nti (n=27)
English: 1 Common
Maltese: 1 Komuni
English: 392 hard capsules
Maltese: 392 kapsula iebsa
English: Localised oedema
Maltese: Edema lokalizzata
English: No major differences were observed for safety and efficacy in patients ≥65 years of age as compared to adults aged 18 to 65 years.
Maltese: Ma deherx li kien hemm differenzi kbar fis-sigurtà u l-effikaċja f'pazjenti ≥65 sena kif imqabbla ma' adulti ta' bejn 18 u 65 sena.
English: Table 5 Grade 3-4 laboratory abnormalities*
Maltese: Anormalitajiet tal-laboratorju ta' Grad 3-4*
English: Overall, 73% of patients were imatinib-resistant, while 27% were imatinib-intolerant.
Maltese: B'mod globali, 73% tal-pazjenti kienu reżistenti għal imatinib, filwaqt li 27% kienu intolleranti għal imatinib.
English: Haematological Response (%) Overall (95%CI) Complete NEL
Maltese: Ematoloġiku (%) (95%CI) Globali Komplet
English: Toxic hepatitis
Maltese: Epatite tossika
English: Table 12 Response in CML
Maltese: Tabella 12 Rispons f'CML
English: Capsule content Lactose monohydrate Crospovidone Type A Poloxamer 188
Maltese: Kontenut tal-kapsula Lactose monohydrate Crospovidone Type A Poloxamer 188
English: Biochemical adverse drug reactions include alanine aminotransferase increased (24%), hyperbilirubinaemia (16%), aspartate aminotransferase increased (12%), lipase increased (11%), blood bilirubin increased (10%), hyperglycaemia (4%), hypercholesterolaemia (3%) and hypertriglyceridaemia (<1%).
Maltese: Reazzjonijiet bijokimiċi avversi tal-mediċina jinkludu żieda ta' alanine aminotransferase (24%), iperbilirubinemija (16%), żieda ta' aspartate aminotransferase (12%), żieda ta' lipase (11%), żieda ta' bilirubina fid-demm (10%), ipergliċemija (4%), iperkolesterolemija (3%) u ipertrigliċeridemija (<1%).
English: Nilotinib is a moderate CYP3A4 inhibitor.
Maltese: Nilotinib huwa inibitur moderat ta' CYP3A4.
English: One hard capsule contains 117.08 mg lactose monohydrate.
Maltese: Kapsula iebsa waħda fiha 117.08 mg lattosju monoidrat.
English: Resistant (n=109)
Maltese: Reżistenti (n=109)
English: CMLCP n=321 Grade
Maltese: CMLFK n=321 Gradi
English: Resistant (n=226)
Maltese: Reżistenti (n=226)
English: Myelosuppression - Neutropenia - Thrombocytopenia - Anaemia
Maltese: Mijelosoppressjoni - Newtropenja - Tromboċitopenja - Anemija
English: Table 3 Non-haematological adverse reactions (≥5% of all patients)*
Maltese: Tabella 3 Reazzjonijiet avversi mhux ematoloġiċi (≥5% tal-pazjenti kollha)*
English: The predicted steady-state Cmax of nilotinib showed an increase of 29%, 18% and 22%, respectively.
Maltese: It-tbassir tas-Cmax ta' nilotinib fl-istat fiss wera żieda ta' 29%, 18% u 22%, rispettivament.
English: Bioavailability/bioequivalence studies
Maltese: Studji ta' bijodisponibilità/bijoekwivalenza
English: Gastrointestinal and CNS haemorrhage were reported in 1% and <1% of patients, respectively.
Maltese: Emorraġġiji gastro-intestinali u tas-CNS kienu rrappurtati f'1% u <1% tal-pazjenti, rispettivament.
English: 120 hard capsules
Maltese: 120 kapsula iebsa
English: Disorientation, confusional state, amnesia, dysphoria Nervous system disorders Common:
Maltese: Disorjentament, stat konfużjonali, amneżija, disforja Disturbi fis-sistema nervuża Komuni:
English: Frequency All grades
Maltese: Frekwenza Gradi kollha
English: The MCyR rate in 321 CP patients was 51%.
Maltese: Ir-rata ta' MCyR f'321 pazjent CP kienet 51%.
English: The bioavailability of nilotinib might be reduced in patients with total gastrectomy (see section 5.2).
Maltese: Il-bijodisponibiltà ta' nilotinib tista' tonqos f'pazjenti b'gastrektomija totali (ara sezzjoni 5.2).
English: Prior interferon
Maltese: Ingħataw interferon qabel
English: Table 1 Paediatric dosing scheme of nilotinib 230 mg/m twice daily
Maltese: Tabella 1 Skema ta' dożaġġ pedjatriku għal nilotinib 230 mg/m darbtejn kuljum
English: Follow all the doctor's instructions carefully.
Maltese: Jista' jkun hemm bżonn attenzjoni medika.
English: By 6 years
Maltese: Sa 6 snin
English: - The other ingredients are lactose monohydrate, crospovidone type A, poloxamer 188, colloidal anhydrous silica, magnesium stearate.
Maltese: - Is-sustanzi mhux attivi l-oħra huma lactose monohydrate , crospovidone Type A, poloxamer 188, colloidal anhydrous silica, magnesium stearate.
English: Leukopenia, eosinophilia, lymphopenia
Maltese: Lewkopenija, eosinofilija, limfopenija
English: What Tasigna contains - The active substance is nilotinib.
Maltese: X'fih Tasigna - Is-sustanza attiva hi nilotinib.
English: Subsequent analyses reflect when patients completed 24, 36, 48, 60 and 72 months of treatment (or discontinued earlier).
Maltese: Analiżi sussegwenti tirrifletti meta l-pazjenti temmew 24, 36, 48, 60 u 72 xahar ta' trattament (jew waqfu qabel).
English: Table 7 MMR rate
Maltese: Tabella 7 Ir-rata tal-MMR
English: Nilotinib is also a substrate for the multi-drug efflux pump, P-glycoprotein (P-gp).
Maltese: Nilotinib huwa sottostrat ukoll għall-pompa ta' effluss ta' ħafna mediċini, glikoproteina-P (P-gp - P-glycoprotein).
English: Table 4 Adverse reactions in adult patients in Tasigna clinical studies (<5% of all patients)
Maltese: Tabella 4 Reazzjonijiet avversi f'pazjenti adulti waqt studji kliniċi b'Tasigna (<5% tal-pazjenti kollha)
English: Shellac (E904) Dehydrated alcohol Isopropyl alcohol Butyl alcohol Propylene glycol Strong ammonia solution Potassium hydroxide Red iron oxide (E172)
Maltese: Dehydrated alcohol Isopropyl alcohol Butyl alcohol Propylene glycol Strong ammonia solution Potassium hydroxide Red iron oxide (E172)
English: As compared to an oral drink solution (pH of 1.2 to 1.3), relative bioavailability of nilotinib capsule is approximately 50%.
Maltese: Meta mqabbla ma' soluzzjoni mill-ħalq bħala xarba (pH ta' 1.2 sa 1.3), il-bijodisponibbilta` relattiva ta' kapsula ta' nilotinib hija ta' madwar 50%.
English: By 4 years
Maltese: Sa 4 snin
English: Plasma protein binding is approximately 98% on the basis of in vitro experiments.
Maltese: It-twaħħil mal-proteina tal-plażma huwa madwar 98% fuq bażi ta' esperimenti in vitro.
English: Treatment-emergent haematological toxicities include myelosuppression: thrombocytopenia (31%), neutropenia (17%) and anaemia (14%).
Maltese: Tossiċitajiet ematoloġiċi li ħarġu mill-kura jinkludu mijelosoppressjoni: tromboċitopenja (31%), newtropenja (17%) u anemija (14%).
English: Table 10 Duration of exposure with nilotinib
Maltese: Tabella 10 Tul tal-esponiment b'nilotinib
English: Nilotinib is primarily metabolised by CYP3A4, with possible minor contribution from CYP2C8.
Maltese: Nilotinib huwa metabolizzat l-aktar permezz ta' CYP3A4, u jista' jkun hemm kontribuzzjoni minuri minn CYP2C8.
English: - Risk Management Plan (RMP)
Maltese: • Pjan tal-Ġestjoni tar-Riskju (RMP)
English: Nilotinib is a potent inhibitor of the ABL tyrosine kinase activity of the BCR-ABL oncoprotein both in cell lines and in primary Philadelphia-chromosome positive leukaemia cells.
Maltese: Nilotinib huwa inibitur potenti tal-attività ABL tyrosine kinase tal-BCR-ABL onkoproteina sew fil-linji ta' ċelluli u fiċ-ċelluli tal-lewkemija pożittivi għall-kromosoma ta' Filadelfja primarja.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE08
Maltese: Sustanzi antineoplastiċi, inibituri tal-protein kinase, Kodiċi ATC:
English: *ANC = absolute neutrophil count
Maltese: *ANC = għadd assolut tan-newtrofili
English: Nilotinib absorption (relative bioavailability) might be reduced by approximately 48% and 22% in patients with total gastrectomy and partial gastrectomy, respectively.
Maltese: L-assorbiment (il-bijodisponibiltà relattiva) ta' nilotinib tista' tonqos b'madwar 48% u 22% f'pazjenti b'gastrektomija totali jew gastrektomija parzjali, rispettivament.
English: Median duration of MCyR was 32.7 months.
Maltese: It-tul ta' żmien medjan għal MCyR kien 32.7 xhur.
English: Treatment-emergent haematological toxicities include myelosuppression: thrombocytopenia (18%), neutropenia (15%) and anaemia (8%).
Maltese: Tossiċitajiet ematoloġiċi li ħarġu mill-kura jinkludu mijelosoppressjoni: tromboċitopenja (18%), newtropenja (15%) u anemija (8%).
English: Tasigna is available in packs containing 28 or 40 hard capsules and in multipacks of 112 hard capsules (comprising 4 cartons, each containing 28 hard capsules), 120 hard capsules (comprising 3 cartons, each containing 40 hard capsules) or 392 hard capsules (comprising 14 cartons, each containing 28 hard capsules).
Maltese: Tasigna jiġi f'pakketti li fihom 28 jew 40 kapsula iebsa u f'pakketti multipli ta' 112-il kapsula iebsa (li jinkludu 4 kartuniet, kull waħda fiha 28 kapsula iebsa), 120 kapsula iebsa (li jinkludu 3 kartuniet, kull waħda fiha 40 kapsula iebsa) jew 392 kapsula iebsa (li jinkludu 14-il kartuna, kull waħda fiha 28 kapsula iebsa).
English: • Unit packs containing 28 hard capsules in a wallet.
Maltese: • Il-pakketti li fihom 28 kapsula iebsa f'wolit.
English: Use in adults - The recommended dose is 800 mg per day.
Maltese: Uzu fl-adulti - Id-doża rakkomandata hija 800 mg kuljum.
English: The rates of MMR at 3, 6, 9 and 12 months were 8.9%, 33.0%, 43.3% and 44.3% for nilotinib 300 mg twice daily, 5.0%, 29.5%, 38.1% and 42.7% for nilotinib 400 mg twice daily and 0.7%, 12.0%, 18.0% and 22.3% for imatinib 400 mg once daily.
Maltese: Ir-rati tal-MMR fi żmien 3, 6, 9 u 12-il xahar kienu 8.9%, 33.0%, 43.3% u 44.3% fil-każ ta' 300 mg nilotinib darbtejn kuljum, 5.0%, 29.5%, 38.1% u 42.7% fil-każ ta' 400 mg nilotinib darbtejn kuljum u 0.7%, 12.0%, 18.0% u 22.3% fil-każ ta' 400 mg imatinib darba kuljum.
English: CMLAP n=137 Grade
Maltese: CMLFA n=137 Gradi
English: Administration of Tasigna 30 minutes or 2 hours after food increased bioavailability of nilotinib by 29% or 15%, respectively (see sections 4.2, 4.4 and 4.5).
Maltese: L-għotja ta' Tasigna 30 minuta jew sagħtejn wara l-ikel iżid il-bijodisponibilità ta' nilotinib b'29% jew 15%, rispettivament (ara sezzjonijiet 4.2, 4.4 u 4.5).
English: In this clinical study with a median on-therapy time of 60.5 months, Grade 3-4 cardiovascular events included peripheral arterial occlusive disease (1.4% and 1.1% at 300 mg and 400 mg nilotinib twice daily, respectively), ischaemic heart disease (2.2% and 6.1% at 300 mg and 400 mg nilotinib twice daily, respectively) and ischaemic cerebrovascular events (1.1% and 2.2% at 300 mg and 400 mg nilotinib twice daily, respectively).
Maltese: F'dan l-istudju kliniku b'ħin medju ta' terapija attiva ta' 60.5 xhur, episodji kardjovaskulari fi Grad 3-4 kienu jinkludu mard okklussiv arterjali periferali (1.4% u 1.1% bi 300 mg u 400 mg nilotinib darbtejn kuljum, rispettivament), mard iskemiku tal-qalb (2.2% u 6.1% bi 300 mg u 400 mg nilotinib darbtejn kuljum, rispettivament) u episodji ċelebrovaskulari iskemiċi (1.1% u 2.2% bi 300 mg u 400 mg nilotinib darbtejn kuljum, rispettivament).
English: Haematoma, peripheral artery stenosis Respiratory, thoracic and mediastinal disorders Common:
Maltese: Ematoma, stenożi tal-arterja periferali Disturbi respiratorji, toraċiċi u medjastinali Komuni:
English: Pancreatitis, gastritis, sensitivity of teeth
Maltese: Pankreatite, gastrite, sensittività tas-snien
English: Intermittent claudication, peripheral arterial occulsive disease, arteriosclerosis
Maltese: Klawdikazzjoni intermittenti, mard okklussiv tal-arterji periferali, arterijosklerożi
English: After imatinib failure, 24 different BCR-ABL mutations were noted in 42% of chronic phase and 54% of accelerated phase CML patients who were evaluated for mutations.
Maltese: Wara li imatinib falla, 24 mutazzjonijiet BCR-ABL differenti kienu nnutati f'42% tal-fażi kronika u 54% tal-fażi aċċelerata tal-pazjenti b'CML li kienu evalwati għall-mutazzjonijiet.
English: 40 hard capsules.
Maltese: 40 kapsula iebsa.
English: Table 2 Dose adjustments for neutropenia and thrombocytopenia
Maltese: Tabella 2 Aġġustamenti tad-doża għal newtropenja u tromboċitopenja
English: Table 9 Best CCyR rate
Maltese: Tabella 9 L-aħjar rata ta' CCyR
English: Imatinib-resistant or intolerant CML-CP and CML-AP 400 mg twice daily n=458
Maltese: Pazjenti b'reżistenza għal imatinib jew CML-CP u CML-AP intolleranti 400 mg darbtejn kuljum n=458
English: Accelerated phase (n=137)*
Maltese: Fażi aċċellerata (n=137)*
English: Chronic phase (n=321)
Maltese: Fażi kronika (n=321)
English: No episodes of torsade de pointes were observed in clinical studies.
Maltese: Ma dehrux episodji ta' torsade de pointes fl-istudji kliniċi.
English: In a retrospective analysis, 91% (234/258) of patients on nilotinib 300 mg twice daily achieved BCR-ABL levels ≤10% at 3 months of treatment compared to 67% (176/264) of patients on imatinib 400 mg once daily.
Maltese: Skont analiżi retrospettiva, 91% (234/258) tal-pazjenti mogħtija 300 mg nilotinib darbtejn kuljum kisbu livelli tal-BCR-ABL ta' ≤10% wara 3 xhur ta' trattament imqabbel mas-67% (176/264) tal-pazjenti mogħtija 400 mg imatinib darbtejn kuljum.
English: The adverse reactions are ranked under heading of frequency using the following convention: very common (≥1/10), common (≥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) and not known (cannot be estimated from the available data).
Maltese: Ir-reazzjonijiet avversi huma elenkati taħt it-titlu tal-frekwenza bil-konvenzjoni li ġejja: 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) u mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: 28 hard capsules 40 hard capsules
Maltese: 28 kapsula iebsa 40 kapsula iebsa
English: The KM estimated MMR and MR4.5 rates at 24 weeks of re-initiation were 98.8% (95% CI: 94.2, 99.9) and 90.9% (95% CI: 83.2, 96.0), respectively.
Maltese: Ir-rati stmati skont il-KM ta' MMR u MR4.5 fl-24 ġimgħa minn mindu reġa' nbeda t-trattament kien ta' 98.8 % (95% CI: 94.2, 99.9) u 90.9 % (95% CI: 83.2, 96.0), rispettivament.
English: Table 4 Adverse reactions in adult patients in the Tasigna Phase III study (<5% of all patients)
Maltese: Tabella 4 Reazzjonijiet avversi f'pazjenti adulti waqt studji f'Fażi III b'Tasigna (<5% tal-pazjenti kollha)
English: Pleural effusion
Maltese: Gradi kollha