FrancophonIA/ELRC3.0 huggingface dataset:
English: In one study involving 25 patients with non-dystrophic myotonia, Namuscla was shown to be more effective than placebo (a dummy treatment) at reducing muscle stiffness.
Maltese: Fi studju wieħed li kien jinvolvi 25 pazjent li jbatu minn mijotonja mhux distrofika, Namuscla ntwera li hu iktar effettiv mill-plaċebo (kura finta) biex titnaqqas l-ebusija tal-muskoli.
English: The dose can be increased up to 3 capsules a day, depending on the intensity of the symptoms and how the patient responds to treatment.
Maltese: Id-doża tista' tiżdied sa 3 kapsuli kuljum, skont l-intensità tas-sintomi u kif il-pazjent jirrispondi għall-kura.
English: As for all medicines, data on the use of Namuscla are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Namuscla hija ssorveljata kontinwament.
English: Tuberculosis e
Maltese: Tuberkulosi e
English: (64.2% versus 38.5%).
Maltese: (64.2% kontra 38.5%).
English: Novartis Farmacéutica S.A. Ronda de Santa Maria 158 08210 Barberà del Vallès, Barcelona Spain
Maltese: Novartis Farmacéutica S.A. Ronda de Santa Maria 158 08210 Barberà del Vallès, Barcelona Spanja
English: 168 tablets (3x56)
Maltese: 168 pillola (3x56)
English: c grade 1
Maltese: c grad 1
English: 90429 Nuremberg Germany
Maltese: 90429 Nuremberg
English: Hydroxypropylcellulose 300 to 600 cps Lactose monohydrate
Maltese: Hydroxypropylcellulose 300 sa 600 cps Lactose monohydrate
English: c grade 1 and 2
Maltese: c gradi 1 u 2
English: Polycythaemia vera (PV)
Maltese: Poliċitemija vera (PV)
English: P value: < .0001 Odds ratio (ruxolitinib/BAT) and 95% CI:
Maltese: Valur p: < .0001 Proporzjon tal-probabbiltajiet (ruxolitinib/BAT) u 95% CI:
English: c grade 3 (> 5x - 20 x ULN)
Maltese: c grad 3 (> 5x - 20 x ULN)
English: Cellulose, microcrystalline Magnesium stearate Silica, colloidal anhydrous Sodium starch glycolate (Type A) Povidone K30
Maltese: Cellulose, microcrystalline Magnesium stearate Silica, colloidal anhydrous Sodium starch glycolate (Tip A) Povidone K30
English: Raised aspartate aminotransferase b
Maltese: Żieda fl-aspartat aminotransferasi b
English: JAK mutation status
Maltese: Stat ta' mutazzjoni JAK
English: Anaemia b
Maltese: Anemija b
English: Table 1 Frequency category of adverse drug reactions reported in the phase 3 studies (COMFORT-I, COMFORT-II, RESPONSE, RESPONSE 2)
Maltese: Tabella 1 Il-kategorija tal-frekwenza tar-reazzjonijiet avversi għall-mediċina rrapportati filfażi 3 tal-istudji (COMFORT-I, COMFORT-II, RESPONSE, RESPONSE 2)
English: Placebo (N=153)
Maltese: Plaċebo (N=153)
English: BAT was selected by the investigator on a patient-bypatient basis and included hydroxyurea (59.5%), interferon/pegylated interferon (11.7%), anagrelide (7.2%), pipobroman (1.8%) and observation (15.3%).
Maltese: Il-BAT intgħażlet mill-investigatur skont ilpazjent individwali u kienet tinkludi hydroxyurea (59.5%), interferon/pegylated interferon (11.7%), anagrelide (7.2%), pipobroman (1.8%) u osservazzjoni (15.
English: COMFORT-II was an open-label, randomised study in 219 patients.
Maltese: COMFORT-II kien studju open-label, randomizzat fost 219-il pazjent.
English: Polycythaemia vera
Maltese: Poliċitemija vera
English: Best available therapy (N=72)
Maltese: L-aħjar terapija possibbli (N=72)
English: Common Terminology Criteria for Adverse Events (CTCAE) version 3.0; grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening d
Maltese: Il-Kriterji ta' Terminoloġija Komuni għal Avvenimenti Avversi (CTCAE) verżjoni 3.0; grad 1 = ħafif, grad 2 = moderat, grad 3 = gravi, grad 4 = theddida għall-ħajja d
English: Multipack: 168 (3 packs of 56) tablets.
Maltese: Pakkett b'ħafna: 168 (3 pakketti ta' 56) pillola.
English: 56 tablets.
Maltese: 56 pillola.
English: - Rifabutin or rifampicin, medicines used to treat tuberculosis (TB).
Maltese: - Rifabutin jew rifampicin, mediċini użati biex jittrattaw it-tuberkolożi (TB).
English: Date of first authorisation: 23 August 2012 Date of latest renewal: 24 April 2017
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 23 Awissu 2012
English: ≥35% reduction in spleen volume
Maltese: Tnaqqis ta' ≥35% fil-volum talmilsa
English: Uncommon (may affect up to 1 in 100 people): - tuberculosis
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100): - tuberkulosi
English: Activating mutations in JAK2 (V617F or exon 12) are found in >95% of PV patients.
Maltese: Mutazzjonijiet ta' attivazzjoni f'JAK2 (V617F jew exon 12) jinstabu f'>95% tal-pazjenti b'PV.
English: Frequency is based on adverse event data.
Maltese: Il-frekwenza tissejjes fuq dejta ta' avvenimenti avversi.
English: Ruxolitinib is eliminated through metabolism catalysed by CYP3A4 and CYP2C9.
Maltese: Ruxolitinib jiġi eleminat permezz tal-metaboliżmu katalizzat b'CYP3A4 u CYP2C9.
English: - The other ingredients are: microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica, sodium starch glycolate, povidone, hydroxypropylcellulose, lactose monohydrate.
Maltese: - Is-sustanzi l-oħra huma: microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica, sodium starch glycolate, povidone, hydroxypropylcellulose, lactose monohydrate.
English: Progressive multifocal leukoencephalopathy
Maltese: Lewkoenċefalopatija Multifokali Progressiva
English: c grade 3 (<8.0 - 6.5g/dl)
Maltese: c grad 3 (<8.0 - 6.5g/dl)
English: c grade 3 (50,000 - 25,000/mm
Maltese: c grad 3 (50,000 - 25,000/mm
English: Lipid abnormalities/elevations
Maltese: Elevazzjonijiet/anormalitajiet tal-lipidi
English: Cytoreductive therapies
Maltese: Terapiji ċitoreduttivi
English: c grade 4 (<6.5g/dl)
Maltese: c grad 4 (<6.5g/dl)
English: At clinically relevant concentrations, ruxolitinib does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A4 and is not a potent inducer of CYP1A2, CYP2B6 or CYP3A4 based on in vitro studies.
Maltese: F'konċentrazzjonijiet relevanti klinikament, ruxolitinib ma jinibixxix CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 jew CYP3A4 u mhuwiex induttur potenti ta' CYP1A2, CYP2B6 jew CYP3A4 skont studji in vitro.
English: Number (%) of subjects with spleen volume reduced by ≥35% 95% confidence intervals p-value
Maltese: Numru (%) ta' pazjenti b'volum tal-milsa mnaqqas b'≥35% 95% ta' intervalli ta' kunfidenza valur-p
English: Of 301 patients, 111 (36.9%) had a baseline platelet count of between 100,000/mm and 200,000/mm and 190 (63.1%) had a baseline platelet count of
Maltese: Minn fost 301 pazjent, 111 (36.9%) kellhom ammont bażi ta' plejtlits ta' bejn 100,000/mm u 200,000/mm u 190 (63.1%) kellhom ammont bażi ta' plejtlits ta' >200,000/mm
English: Tuberculosis has been reported in patients receiving Jakavi.
Maltese: It-tuberkulosi kienet irrappurtata f'pazjenti li rċevew Jakavi.
English: Infections and infestations Urinary tract infections a,d
Maltese: Infezzjonijiet u infestazzjonijiet Infezzjonijiet tal-passaġġ urinarju a,d
English: Myelofibrosis (MF)
Maltese: Mjelofibrożi (MF)
English: Starting dose
Maltese: Id-doża inizjali
English: Hypercholesterolaemia b
Maltese: Iperkolesterolemija b
English: The safety and effectiveness of Jakavi in paediatric patients have not been established (see section 5.1, “Paediatric population”).
Maltese: Is-sigurtà u l-effettività ta' Jakavi f'pazjenti pedjatriċi ma ġewx stabbiliti (ara sezzjoni 5.1, “Popolazzjoni pedjatrika”).
English: At week 32, 49% and 64% of patients treated with ruxolitinib achieved a ≥50% reduction in TSS-14 and TSS-5, respectively, compared to only 5% and 11% of patients on BAT.
Maltese: Fit-32 ġimgħa, 49% u 64% tal-pazjenti kkurati b'ruxolitinib kisbu tnaqqis ta' ≥50% fit-TSS-14 u fit-TSS-5, rispettivament, imqabbel ma' 5% u 11% biss tal-pazjenti fuq BAT.
English: COMFORT-I was a double-blind, randomised, placebo-controlled study in 309 patients who were refractory to or were not candidates for available therapy.
Maltese: COMFORT-I kien studju double-blind, randomizzat, ikkontrollat bi plaċebo fost 309 pazjenti li kienu refrattarji għat-terapija disponibbli jew ma kenux kandidati għaliha.
English: Ruxolitinib is a selective inhibitor of the Janus Associated Kinases (JAKs) JAK1 and JAK2 (IC50 values of 3.3 nM and 2.8 nM for JAK1 and JAK2 enzymes, respectively).
Maltese: Ruxolitinib hu inibitur selettiv ta' Kinasi Assoċjat ma' Janus (JAKs) JAK1 u JAK2 (valuri IC50 ta' 3.3 nM u 2.8 nM għall-enzimi
English: Anaemia or thrombocytopenia CTCAE grade 3 and 4 were reported in respectively 1.1% or 3.3%.
Maltese: Kienu rrapportati anemija jew tromboċitopenija fil-gradi 3 u 4 ta' CTCAE f'1.1% jew 3.3% tal-pazjenti, rispettivament.
English: Bruising events were more frequently reported in patients taking ruxolitinib compared with the reference treatments (21.3% versus 11.6%).
Maltese: Episodji ta' tbenġil kienu rrappurtati b'aktar frekwenza f'pazjenti li jieħdu ruxolitinib mqabbel mat-trattamenti ta' referenza (21.3% kontra 11.6%).
English: The three most frequent non-haematological laboratory abnormalities were raised alanine aminotransferase (27.2%), raised aspartate aminotransferase (19.9%) and hypercholesterolaemia (16.9%).
Maltese: L-aktar tliet anormalitajiet mhux ematoloġiċi frekwenti fil-laboratorju kienu żieda fl-alanina aminotransferasi (27.2%), żieda fl-aspartat aminotransferasi (19.9%) u iperkolesterolemija (16.9%).
English: What Jakavi contains - The active substance of Jakavi is ruxolitinib.
Maltese: X'fih Jakavi - Is-sustanza attiva ta' Jakavi hi ruxolitinib.
English: Jakavi 5 mg tablets Jakavi 10 mg tablets Jakavi 15 mg tablets Jakavi 20 mg tablets
Maltese: Jakavi 5 mg pilloli Jakavi 10 mg pilloli Jakavi 15 mg pilloli Jakavi 20 mg pilloli
English: Headache a
Maltese: Uġigħ ta' ras a
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE18
Maltese: Aġenti antineoplastiċi, inibituri tal-proteina tal-kinasi, Kodiċi ATC:
English: There was a 31% reduction in the risk of death in the ruxolitinib arm as compared to placebo (HR 0.69; 95% CI 0.50-0.96; p=0.025).
Maltese: Kien hemm tnaqqis ta' 31% fir-riskju ta' mewt fil-grupp mogħti ruxolitinib imqabbel mal-plaċebo (HR 0.69; 95% CI 0.50-0.96; p=0.025).
English: In addition, the corresponding frequency category for each adverse drug reaction is based on 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).
Maltese: Barra minn hekk, ilkategorija ta' frekwenza korrispondenti għal kull reazzjoni avversa tal-mediċina tissejjes fuq ilkonvenzjoni 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).
English: c grade 3 (<1,000 - 500/mm
Maltese: c grad 3 (<1,000 - 500/mm
English: One patient (0.3%) discontinued treatment because of anaemia.
Maltese: Pazjent wieħed (0.3%) waqqaf it-trattament minħabba anemija.
English: MF patients exhibit dysregulated JAK signalling regardless of JAK2V617F mutation status.
Maltese: Pazjenti b'MF juru sinjali ta' disregulazzjoni ta' JAK indipendentament mill-istat ta' mutazzjoni ta' JAK2V617F.
English: Gastrointestinal bleeding
Maltese: Fsada gastrointestinali
English: Mean ruxolitinib Cmax and total exposure (AUC) increased proportionally over a single dose range of 5-200 mg.
Maltese: Is-Cmax medju ta' ruxolitinib u l-espożizzjoni totali (AUC) żdiedu proporzjonalment wara lgħoti ta' doża singola ta' bejn 5-200 mg.
English: Patients were randomised 2:1 to ruxolitinib versus best available therapy.
Maltese: Il-pazjenti kienu randomizzati 2:1 b'ruxolitinib kontra l-aħjar terapija disponibbli.
English: The safety of Jakavi was assessed in 184 patients with PV in two open-label, randomised, controlled studies, the phase 3 RESPONSE study and the phase 3b RESPONSE 2 study.
Maltese: Is-sigurtà ta' Jakavi ġiet ivvalutata f'184 pazjenti b'PV f'żewġ studji open-label, randomised u kkontrollati, l-istudju ta' fażi 3 RESPONSE u l-istudju ta' fażi 3b RESPONSE 2.
English: Two randomised phase 3 studies (COMFORT-I and COMFORT-II) were conducted in patients with MF (primary MF, post-polycythaemia vera MF or post-essential thrombocythaemia MF).
Maltese: Saru żewġ studji randomizzati f'fażi 3 (COMFORT-I u COMFORT-II) f'pazjenti b'MF (MF primarja, MF post-poliċitemija vera jew MF post-tromboċitemija essenzjali).
English: c grade 4 (<500/mm
Maltese: c grad 4 (<500/mm
English: Effects of age, gender or race
Maltese: L-effetti tal-età, is-sess jew ir-razza
English: In the PV population, the CTCAE grade 3 and 4 events were reported in 2.7%, while in the MF patients the frequency was 42.56%.
Maltese: Fil-popolazzjoni ta' pazjenti b'PV, ġew irrappurtati avvenimenti ta' CTCAE gradi 3 u 4 f'2.7% tagħhom, filwaqt li fil-pazjenti b'MF il-frekwenza kienet ta' 42.56%.
English: In the best available therapy arm, 47% of patients received hydroxyurea and 16% of patients received glucocorticoids.
Maltese: Fost il-pazjenti mogħtija l-aħjar terapija disponibbli, 47% tal-pazjenti ngħataw hydroxyurea u 16% tal-pazjenti ngħataw glucocorticoids.
English: Ruxolitinib inhibits JAK-STAT signalling and cell proliferation of cytokine-dependent cellular models of haematological malignancies, as well as of Ba/F3 cells rendered cytokine-independent by expressing the JAK2V617F mutated protein, with IC50 ranging from 80-320 nM.
Maltese: Ruxolitinib jinibixxi s-sinjali ta' JAK-STAT u l-proliferazzjoni taċ-ċellola ta' mudelli ċellulari dipendenti miċ-ċitokina ta' tumuri malinni ematoloġiċi, kif ukoll ta' ċelloli Ba/F3 li jispiċċaw indipendenti miċ-ċitokina billi jesebixxu l-proteina mibdula JAK2V617F, b'IC50 mifrux fuq 80-320 nM.
English: In phase 3 clinical studies sepsis was reported in 3.0% of patients.
Maltese: Fi studji kliniċi ta' fażi 3 sepsis kien irrappurtat fi 3.0% tal-pazjenti.
English: 14 tablets 56 tablets
Maltese: 14-il pillola 56 pillola
English: Enzyme inducers
Maltese: Indutturi tal-enzimi
English: Excipient with known effect Each tablet contains 71.45 mg lactose monohydrate.
Maltese: Eċċipjent b'effett magħruf Kull pillola fiha 71.45 mg lattosju monoidrat.
English: The sum total of all active metabolites contributes to 18% of the overall pharmacodynamics of ruxolitinib.
Maltese: Is-somma totali talmetaboliti attivi kollha tikkontribwixxi għal 18% tal-farmakodinamiċità sħiħa ta' ruxolitinib.
English: c grade 4 (<25,000/mm
Maltese: c grad 4 (<25,000/mm
English: In vitro data indicate that ruxolitinib may inhibit P-gp and BCRP.
Maltese: Dejta in vitro turi li ruxolitinib jista' jinibixxi P-gp u BCRP.
English: Anaemia, thrombocytopenia and neutropenia are dose-related effects.
Maltese: L-anemija, it-tromboċitopenija u n-newtropenija huma effetti marbuta mad-doża.
English: - Nefazodone, a medicine to treat depression.
Maltese: - Nefazodone, mediċina biex tittratta d-dipressjoni.
English: Haematological adverse drug reactions (any Common Terminology Criteria for Adverse Events [CTCAE] grade) included anaemia (82.4%), thrombocytopenia (69.8%) and neutropenia (16.6%).
Maltese: Ir-reazzjonijiet avversi ematoloġiċi tal-mediċina (kull grad ta' Kriterji ta' Terminoloġija Komuni għal Episodji Avversi [CTCAE]) kienu jinkludu l-anemija (82.4%), it-tromboċitopenija (69.8%) u nnewtropenija (16.6%).
English: Hepatobiliary disorders Raised alanine aminotransferase b
Maltese: Żieda fl-alanina aminotransferasi b
English: Other bleeding events (including events such as epistaxis, post-procedural haemorrhage and haematuria) were reported in 13.3% of patients treated with ruxolitinib and 10.3% treated with reference treatments.
Maltese: Kienu rrappurtati episodji oħrajn ta' fsada (inkluż episodji bħalma huma epistassi, emorrarġija wara operazzjonijiet u ematurja) fi 13.3% tal-pazjenti kkurati b'ruxolitinib u f'10.3% kkurati bi trattamenti ta' referenza.
English: In the randomised period of the pivotal studies, anaemia was less frequent in PV patients than in MF patients (40.8% versus 82.4%).
Maltese: Fil-perjodu randomizzat tal-istudji pivotali, l-anemija kienet inqas frekwenti f'pazjenti b'PV milli f'pazjenti b'MF (40.8% versus 82.4%).
English: - Phenytoin, carbamazepine or phenobarbital and other anti-epileptics used to stop seizures or fits.
Maltese: - Phenytoin, carbamazepine jew phenobarbital u anti-epilettiċi oħrajn użati biex iwaqqfu l aċċessjonijiet.
English: Intracranial bleeding was reported in 1% of patients exposed to ruxolitinib and 0.9% exposed to reference treatments.
Maltese: Kienet irrappurtata fsada intrakranjali f'1% tal-pazjenti esposti għal ruxolitinib u f'0.9% esposti għal trattamenti ta' referenza.
English: Haematological adverse reactions (any CTCAE grade) included anaemia (40.8%) and thrombocytopenia (16.8%).
Maltese: Ir-reazzjonijiet avversi ematoloġiċi (kwalunkwe grad ta' CTCAE) kienu jinkludu l-anemija (40.8%) u t-tromboċitopenija (16.8%).
English: Two major and active metabolites are present in plasma representing 25% and 11% of parent AUC.
Maltese: Żewġ metaboliti maġġuri u attivi jinsabu filplażma li jirrappreżentaw 25% u 11% tal-AUC ewlieni.
English: Dual CYP2C9 and CYP3A4 inhibitors
Maltese: Inibituri doppji ta' CYP2C9 u ta' CYP3A4
English: There was a 33% reduction in risk of death in the ruxolitinib arm compared to the BAT arm (HR 0.67; 95% CI 0.44-1.02; p=0.062).
Maltese: Kien hemm tnaqqis ta' 33% fir-riskju ta' mewt fil-grupp mogħti ruxolitinib imqabbel mal-grupp BAT (HR 0.67; 95% CI 0.44-1.02; p=0.062).
English: The rate of herpes zoster was similar in PV (4.3%)
Maltese: Ir-rata ta' herpes zoster kienet simili f'pazjenti b'PV (4.3%) u f'pazjenti b'MF (4.0%).
English: These include medicines used to treat fungal diseases (such as ketoconazole, itraconazole, posaconazole, fluconazole and voriconazole), medicines used to treat certain types of bacterial infections (antibiotics such as clarithromycin, telithromycin, ciprofloxacin, or erythromycin), medicines to treat viral infections, including HIV infection/AIDS (such as amprenavir, atazanavir, indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir), medicines to treat hepatitis C (boceprevir, telaprevir).
Maltese: Dawn jinkludu mediċini użati biex wieħed jittratta l-mard tal-moffa (bħalma huma ketoconazole, itraconazole, posaconazole, fluconazole u voriconazole), mediċini użati biex wieħed jittratta ċerti tipi ta' infezzjonijiet batteriċi (antibijotiċi bħalma huma clarithromycin, telithromycin, ciprofloxacin, jew erythromycin), mediċini biex jittrattaw infezzjonijiet virali, li jinkludu infezzjoni tal-HIV/AIDS (bħalma huma amprenavir, atazanavir, indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir), mediċini biex jittrattaw l-epatite Ċ (boceprevir, telaprevir).
English: Ruxolitinib has been evaluated in safety pharmacology, repeated dose toxicity, genotoxicity and reproductive toxicity studies and in a carcinogenicity study.
Maltese: Ruxolitinib ġie evalwat fi studji dwar is-sigurtà farmakoloġika, it-tossiċità minħabba dożi ripetuti, ilġenotossiċità u t-tossiċità riproduttiva u fi studju dwar il-karċinoġenetiċità.
English: The frequency of severe (i.e. CTCAE grade 3 and 4) thrombocytopenia was lower in PV (2.7%) than in MF (11.6%) patients.
Maltese: Il-frekwenza ta' tromboċitopenija gravi (jiġifieri CTCAE gradi 3 u 4) kienet aktar baxxa f'pazjenti b'PV (2.7%) milli f'pazjenti b'MF (11.6%).
English: Blood and lymphatic system disorders b,d
Maltese: Disturbi tad-demm u tassistema limfatika b,d
English: Excipient with known effect Each tablet contains 214.35 mg lactose monohydrate.
Maltese: Eċċipjent b'effett magħruf Kull pillola fiha 214.35 mg lattosju monoidrat.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of ruxolitinib and its metabolites in milk (see section 5.3).
Maltese: Dejta farmakodinamika/tossikoloġika disponibbli minn fost l-annimali wriet l-eliminazzjoni ta' ruxolitinib u tal-metaboliti tiegħu mill-ħalib (ara sezzjoni 5.3).
English: This may result in increased sytemic exposure of substrates of these transporters, such as dabigatran etexilate, ciclosporin, rosuvastatin and potentially digoxin.
Maltese: Dan jista' jwassal għal żieda fl-espożizzjoni sistemika tas-substrati ta' dawn it-trasportaturi, bħalma huma dabigatran etexilate, ċiklosporina, rosuvastatin u probabbilment digoxin.
English: Nervous system disorders Dizziness a
Maltese: Disturbi fis-sistema nervuża Sturdament a
English: Jakavi 15 mg tablets EU/1/12/773/007-009
Maltese: Jakavi 15 mg pilloli EU/1/12/773/007-009
English: The mean volume of distribution at steady state is approximately 75 litres in MF and PV patients.
Maltese: Il-volum medju tad-distribuzzjoni fi stat stabbli huwa ta' bejn wieħed u ieħor 75 litru f'pazjenti b'MF u b'PV.
English: Other side effects with Jakavi
Maltese: Effetti sekondarji oħrajn b'Jakavi
English: Jakavi 10 mg tablets EU/1/12/773/014-016
Maltese: Jakavi 10 mg pilloli EU/1/12/773/014-016
English: Based on unbound AUC, the exposure at the NOAEL (no observed adverse effect level) in juvenile rats treated as early as postnatal day 7 was 0.3-fold that of adult patients at 25 mg twice daily, while reduced bone growth and fractures occurred at exposures that were 1.5- and 13-fold that of adult patients at 25 mg twice daily, respectively.
Maltese: Skont AUC li ma jeħilx, l-espożizzjoni f'NOAEL (livell ta' ebda effett avvers osservat) f'firien mhux adulti sa mis-7 jum wara t-twelid kienet ta' 0.3 drabi aktar minn dik ta' pazjenti adulti mogħtija 25 mg darbtejn kuljum, filwaqt li kien hemm tnaqqis fit-tkabbir u l-ksur tal-għadam f'espożizzjonijiet li kienu 1.5 drabi u 13-il darba minn dik ta' pazjenti adulti mogħtija 25 mg darbtejn kuljum, rispettivament.
English: Excipient with known effect Each tablet contains 142.90 mg lactose monohydrate.
Maltese: Eċċipjent b'effett magħruf Kull pillola fiha 142.90 mg lattosju monoidrat.
English: Jakavi 20 mg tablets EU/1/12/773/010-012
Maltese: Jakavi 20 mg pilloli EU/1/12/773/010-012
English: Primary composite endpoint at week 32
Maltese: Endpoint kompost primarju fit32 ġimgħa
English: Non-melanoma skin cancer
Maltese: Kanċer tal-ġilda non-melanoma
English: Progressive multifocal leukoencephalopathy (PML) has been reported with Jakavi treatment.
Maltese: Lewkoenċefalopatija Multifokali Progressiva (PML) kienet irrappurtata waqt kura b'Jakavi.
English: Neutropenia (absolute neutrophil count <500) was generally reversible and was managed by temporarily withholding Jakavi (see sections 4.2 and 4.8).
Maltese: In-newtropenija (ammont assolut ta' newtropenija <500) kienet ġeneralment riversibbli u kienet immaniġġjata permezz ta' twaqqif temporanju ta' Jakavi (ara sezzjonijiet 4.2 u 4.8).
English: CYP3A4 inducers (such as, but not limited to, avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin (rifampicin), St.John's wort (Hypericum perforatum)) Patients should be closely monitored and the dose titrated based on safety and efficacy (see section 4.2).
Maltese: (bħalma huma, imma mhux biss, avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin (rifampicin), St.John's wort (Hypericum perforatum))
English: The median age was 60 years (range 33 to 90 years).
Maltese: Letà medja kienet 60 sena (b'firxa minn 33 sa 90 sena).
English: The terminal elimination half-life was prolonged in patients with hepatic impairment compared to healthy controls (4.1-5.0 hours versus 2.8 hours).
Maltese: Il-half-life tal-eliminazzjoni terminali twal f'pazjenti b'indeboliment epatiku mqabbel ma' kontrolli b'saħħithom (4.1-5.0 sigħat kontra 2.8 sigħat).
English: Treatment with Jakavi has been associated with increases in lipid parameters including total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides.
Maltese: It-trattament b'Jakavi ġie assoċjat ma' żieda fil-parametri tal-lipidi li tinkludi l-kolesterol kollu, ilkolesterol tal-lipoproteina b'densità għolja (HDL), il-kolesterol tal-liproproteina b'densità baxxa (LDL), u t-trigliċeridi.
English: Long-term safety:
Maltese: Sigurtà fit-tul: