FrancophonIA/ELRC3.0 huggingface dataset:
English: • myelodysplastic or myeloproliferative diseases (MD/MPD), a group of diseases in which the body produces large numbers of abnormal blood cells.
Maltese: • mard mjelodisplastiku jew mjeloproliferativ (MD/MPD), grupp ta' mard fejn il-ġisem jipproduċi numri kbar ta' ċelloli tad-demm anormali.
English: • dermatofibrosarcoma protuberans (DFSP), a type of cancer (sarcoma) in which cells in the tissue beneath the skin divide uncontrollably.
Maltese: • dermatofibrosarkoma protuberans (DFSP), tip ta' kanċer (sarkoma) li fih iċ-ċelloli fit-tessut ta' taħt il-ġilda jinqasmu b'mod inkontrollabbli.
English: Imatinib Teva is used to treat adults with HES or CEL who have a specific re-arrangement of two genes called FIP1L1 and PDGFRα;
Maltese: Imatinib Teva jintuża għall-kura tal-adulti bl-HES jew bis-CEL li għandhom- arranġament mill-ġdid speċifiku ta' żewġ ġeni msejħa FIP1L1 u PDGFRα;
English: How has Imatinib Teva been studied?
Maltese: Kif ġie studjat Imatinib Teva?
English: Because Imatinib Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Imatinib Teva huwa mediċina ġenerika u bijoekwivalenti għall-mediċina ta' referenza, jitqies li l-benefiċċji u r-riskji tiegħu huma l-istess bħal dawk tal-mediċina ta' referenza.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Imatinib Teva has been shown to have comparable quality and to be bioequivalent to Glivec.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li, b'mod konformi marrekwiżiti tal-UE, Imatinib Teva wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Glivec.
English: What are the benefits and risks of Imatinib Teva?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Imatinib Teva?
English: Imatinib Teva is used to treat adults with DFSP that cannot be removed with surgery, and in adults who are not eligible for surgery when the cancer has returned after treatment or has spread to other parts of the body.
Maltese: Imatinib Teva jintuża għall-kura tal-adulti b'DFSP li ma jistax jitneħħa b'intervent kirurġiku, u f'adulti li ma jkunux eliġibbli għal intervent kirurġiku meta lkanċer ikun reġa' tfaċċa wara l-kura jew meta dan ikun infirex f'partijiet oħra tal-ġisem.
English: How is Imatinib Teva used?
Maltese: Kif jaħdem Imatinib Teva?
English: It is also used in adults and children in the ‘chronic phase' of the disease if it is not responding to interferon alpha (another cancer medicine), and in more advanced phases of the disease (‘accelerated phase' and ‘blast crisis');
Maltese: Jintuża wkoll f'adulti u tfal li jinsabu fil‘fażi kronika' tal-marda jekk ma tkunx qed tirrispondi għall-interferon alfa (mediċina oħra kontra lkanċer), u f'fażijiet oħra aktar avvanzati tal-marda (‘fażi aċċellerata' u ‘terminali');
English: Strength Pharmaceutical Form
Maltese: Forma Farmaċewtika
English: Route of administration
Maltese: Mod t'amministrazzjoni
English: EU - Number Invented name
Maltese: Numru tal-UE Isem ivvintat Saħħa
English: Target Species
Maltese: Żmien ta' iżmim
English: EPAR summary for the public mercaptopurine
Maltese: Sommarju tal-EPAR għall-pubbliku merkaptopurina
English: The full EPAR for Xaluprine can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Xaluprine can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għal Prodotti Mediċinali Orfni għal Xaluprine jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
English: It is available as an oral suspension.
Maltese: Tiġi f'suspensjoni orali.
English: This summary was last updated in 09-2012.
Maltese: Is-sommarju ġie aġġornat l-aħħar f': 09-2012.
English: This is a summary of the European public assessment report (EPAR) for Xaluprine.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Xaluprine.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xaluprine on 9 March 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Xaluprine fil-9 ta' Marzu 2012.
English: Because the number of patients with ALL is low, the disease is considered ‘rare', and Xaluprine was designated an ‘orphan medicine' (a medicine used in rare diseases) on 30 April 2009.
Maltese: Minħabba li għadd ta' pazjenti li għandhom ALL huwa baxx, il-marda titqies ‘rari', u fit-30 ta' April 2009 Xaluprine ġie kklassifikat bħala ‘mediċina orfni' (mediċina li tintuża kontra mard rari).
English: The active substance in this medicine, mercaptopurine has a similar chemical structure to purine, which is one of the fundamental chemicals that make up DNA.
Maltese: Is-sustanza attiva f'din il-mediċina, il-merkaptopurina, għandha struttura kimika simili bħall-purina, li hija waħda mill-kimiċi fundamentali li jsawru d-DNA.
English: Other information about Xaluprine
Maltese: Informazzjoni oħra dwar Xaluprine
English: Xaluprine is a medicine that contains the active substance mercaptopurine.
Maltese: Xaluprine hija mediċina li fiha s-sustanza attiva merkaptopurina.
English: The most common side effects with mercaptopurine (seen in more than 1 patient in 10) are leucopenia (low white blood cell counts) and thrombocytopenia (low blood platelet counts).
Maltese: L-aktar effetti sekondarji komuni bil-merkaptopurina (li dehru f'aktar minn pazjent 1 minn kull 10) huma lewkopenija (livell baxx ta' ċelloli bojod fid-demm) u tromboċitopenija (livelli baxxi ta' pjastrini fid-demm).
English: Xaluprine is used to treat children, adolescents and adults who have acute lymphoblastic leukaemia (ALL), a cancer of the lymphocytes (a type of white blood cell).
Maltese: Xaluprine jintuża biex jikkura t-tfal, l-adoloxxenti u l-adulti li jkollhom lewkemja limfoblastika akuta (ALL), li hija kanċer tal-limfoċiti (tip ta' ċellola bajda tad-demm).
English: Why has Xaluprine been approved?
Maltese: Għaliex ġie approvat Xaluprine?
English: The medicine can only be obtained with a prescription.
Maltese: Il-mediċina tinkiseb biss bi preskrizzjoni medika.
English: What is Xaluprine?
Maltese: X'inhu Xaluprine?
English: What is the risk associated with Xaluprine?
Maltese: X'inhu r-riskju assoċjat ma' Xaluprine?
English: In the body, 6-mercaptopurine is converted within cells into a substance that interferes with the production of new DNA.
Maltese: Fil-ġisem, 6-merkaptopurina tibidel ġewwa ċċelloli f'sustanza li tinterferixxi mal-produzzjoni ta' DNA ġdid.
English: The CHMP noted that mercaptopurine is established as an important treatment for ALL and that the only authorised form in the EU is a 50 mg tablet, making it difficult to adjust the dose for smaller children.
Maltese: Is-CHMP osserva li l-merkaptopurina hija stabbilita bħala kura importanti għal ALL u li l-unika għamla awtorizzata fl-UE hija pillola ta' 50 mg, u dan jagħmilha diffiċli biex id-doża tiġi aġġustata għal tfal iżgħar.
English: The Committee considered that an oral suspension allows more accurate dosing and is more convenient for children unable to swallow tablets.
Maltese: Sar ukoll studju li qabbel il-bijodisponibbiltà ta' Xaluprine, li hija sospensjoni orali, ma' dik tal-pillola.
English: How has Xaluprine been studied?
Maltese: Kif ġie studjat Xaluprine?
English: 6mercaptopurine prevents them from dividing and they eventually die, thereby slowing down the progression of the leukaemia.
Maltese: Is-6-merkaptopurina xxekkilhom milli jinqasmu u maż-żmien dawn imutu.
English: How does Xaluprine work?
Maltese: Għal xiex jintuża Xaluprine?
English: The effectiveness of 6-mercaptopurine in slowing down the progression of ALL is already well known since it has been used for many years.
Maltese: L-effikaċja tas-6-merkaptopurina fit-tnaqqis tal-veloċità tal-progressjoni ta' ALL diġà hija magħrufa sew minħabba li ilha tintuża bosta snin.
English: The bioavailability study showed that Xaluprine is comparable to the tablets, but it works in a more predictable way and has a higher rate of absorption, for which reason the dose will need to be adjusted when a patient switches from one formulation to the other.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati bi Xaluprine, ara l-fuljett ta' tagħrif.
English: Days 2 to 3
Maltese: Jiem 2 sa 3
English: Days 2 to 4
Maltese: Jiem 2 sa 4
English: EU/1/15/1001/001 EU/1/15/1001/002
Maltese: EU/1/15/1001/002
English: Netupitant tablets Microcrystalline cellulose (E460) Sucrose lauric acid esters Povidone K-30
Maltese: Pilloli netupitant Microcrystalline cellulose (E460) Sucrose lauric acid esters Povidone K-30
English: Croscarmellose sodium Colloidal hydrated silica Sodium stearyl fumarate Magnesium stearate
Maltese: Colloidal hydrated silica Sodium stearyl fumarate Magnesium stearate
English: EU/1/15/1001/001 1 hard capsule EU/1/15/1001/002 4x1 hard capsules
Maltese: EU/1/15/1001/001 1 kapsula iebsa EU/1/15/1001/002 4x1 kapsuli ibsin
English: Glycerol monocaprylocaproate (type I) Glycerol
Maltese: Kontenut tal-kapsula Glycerol monocaprylocaproate (tip I) Glycerol
English: The usual dose is 1 capsule.
Maltese: Id-doża normali hi ta' 1 kapsula.
English: Erythromycin and Midazolam
Maltese: Erythromycin u Midazolam
English: 1 hard capsule 4x1 hard capsules
Maltese: 1 kapsula iebsa 4x1 kapsuli ibsin
English: Netupitant is a selective antagonist of human substance P/neurokinin 1 (NK1) receptors.
Maltese: Netupitant hu antagonist selettiv tas-sustanza umana, riċetturi ta' P/neurokinin 1 (NK1).
English: Shellac glaze (partially esterified) Black iron oxide (E172) Propylene glycol (E1520)
Maltese: Shellac glaze (parzjalment esterifikat) Black iron oxide (E172) Propylene glycol (E1520)
English: Vifor France Tél: +33 (0)1 41 06 58 90
Maltese: Tél: +33 (0)1 41 06 58 90
English: moxifloxacin, haloperidol, chlorpromazine, quetiapine, thioridazine or domperidone
Maltese: quinidine, moxifloxacin, haloperidol, chlorpromazine, quetiapine, thioridazine jew domperidone
English: Pharmacotherapeutic group: Antiemetics and antinauseants, serotonin (5-HT3) antagonists; ATC code: A04AA55
Maltese: Antiemetiċi u antinawseanti, antagonisti ta' serotonin (5-HT3); Kodiċi ATC:
English: Palonosetron soft capsule
Maltese: Palonosetron kapsula ratba
English: Common (≥1/100 to <1/10),
Maltese: Komuni (≥1/100 sa <1/10),
English: Netupitant was shown to cross the blood brain barrier with a NK1 receptor occupancy of 92.5%, 86.5%, 85.0%, 78.0%, and 76.0% in striatum at 6, 24, 48, 72, and 96 hours, respectively, after administration of 300 mg netupitant.
Maltese: Intwera li netupitant jaqsam il-barriera demm-moħħ b'okkupanza tar-riċettur ta' NK1 ta' 92.5%, 86.5%, 85.0%, 78.0%, u 76.0% fl-istriatum wara 6, 24, 48, 72, u 96 siegħa, rispettivament, wara lgħoti ta' 300 mg ta' netupitant.
English: Three metabolites have been detected in human plasma at netupitant oral doses of 30 mg and higher (the desmethyl derivative, M1; the N-oxide derivative, M2; the OH-methyl derivative, M3).
Maltese: Tliet metaboliti ġew osservati fil-plażma umana f'dożi orali ta' netupitant ta' 30 mg u ogħla (idderivattiv ta' desmethyl, M1; id-derivattiv ta' N-oxide, M2; id-derivattiv ta' OH-methyl, M3).
English: Helsinn Birex Pharmaceuticals Ltd. Damastown, Mulhuddart Dublin 15,
Maltese: Damastown, Mulhuddart Dublin 15,
English: Interaction between oral netupitant and oral palonosetron:
Maltese: Interazzjoni bejn netupitant orali u palonosetron orali:
English: • The other ingredients are microcrystalline cellulose (E460), sucrose lauric acid esters, povidone K-30, croscarmellose sodium, colloidal hydrated silica, sodium stearyl fumarate, magnesium stearate, glycerol monocaprylocaproate (type I), glycerol, polyglyceryl oleate, purified water, butylhydroxyanisole (E320), gelatin, sorbitol, 1,4 sorbitan, titanium dioxide (E171), shellac glaze (partially esterified), yellow, red and black iron oxide (E172), propylene glycol (E1520).
Maltese: • Is-sustanzi mhux attivi l-oħra huma microcrystalline cellulose (E460), sucrose lauric acid esters, povidone K-30, croscarmellose sodium, colloidal hydrated silica, sodium stearyl fumarate, magnesium stearate, glycerol monocaprylocaproate (tip I), glycerol, polyglyceryl oleate, ilma ppurifikat, butylhydroxyanisole (E320), ġelatina, sorbitol, 1,4 sorbitan, titanium dioxide (E171),
English: such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram or escitalopram
Maltese: serotonin) - bħal fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram jew escitalopram
English: The AUC0-24 (Day 1), the AUC24-36 (Day 2) and the AUC84-108 and AUC84-∞ (Day 4) of dexamethasone increased 2.4-fold, with co-administration of 300 mg netupitant.
Maltese: (Jum 1), l-AUC24-36 (Jum 2) u l-AUC84-108 u l-AUC84-∞ (Jum 4) ta' dexamethasone żdiedu bi 2.4 darbiet, bl-għoti flimkien ta' 300 mg ta' netupitant.
English: • rifampicin - to treat tuberculosis (TB) and other infections.
Maltese: • rifampicin - biex jikkura t-tuberkulożi (TB) u infezzjonijiet oħrajn.
English: Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu.
Maltese: Mediċini http://www.ema.europa.eu/.
English: * p-value from Cochran-Mantel-Haenszel test, stratified by age class and region.
Maltese: Fażi globali * valur-p mill-Cochran-Mantel-Haenszel test, stratifikat skont l-età, klassi u reġjun.
English: Caution is recommended when netupitant is combined with an oral substrate of this enzyme (e.g.zidovudine, valproic acid, morphine).
Maltese: Il-kawtela hi rakkomandata meta netupitant jiġi kkombinat ma' substrat orali ta' din l-enzima (eż. zidovudine, valproic acid, morfina).
English: • ketoconazole - to treat Cushing's syndrome
Maltese: • ketoconazole - biex tikkura s-sindrome ta' Cushing
English: Interaction with CYP3A4 substrates:
Maltese: Interazzjoni ma' substrati ta' CYP3A4:
English: There was a supra-proportional increase in Cmax and AUC parameters for doses from 10 mg to 300 mg.
Maltese: Kien hemm żieda supraproporzjonali fil-parametri tas-Cmax u l-AUC għal dożi minn 10 mg sa 300 mg.
English: Date of first authorisation: 27 May 2015 Date of latest renewal:
Maltese: Data tal-ewwel awtorizzazzjoni: 27 Mej 2015
English: Each hard capsule contains 7 mg of sorbitol and 20 mg of sucrose.
Maltese: Kull kapsula iebsa fiha 7 mg ta' sorbitol u 20 mg ta' sucrose.
English: Netupitant is not mutagenic.
Maltese: Netupitant mhuwiex mutaġeniku.
English: In a study performed in healthy volunteers, netupitant does not affect the exposure of digoxin, a P-gp substrate, whereas it increases its Cmax by 1.09 fold [90%CI 0.9-1.31].
Maltese: Fi studju li twettaq f'voluntiera b'saħħithom, netupitant ma affettwax l-esponiment ta' digoxin, substrat ta' P-gp, filwaqt li żied is-Cmax tiegħu b'1.09 darbiet [90%CI 0.9-1.31].
English: • high levels of creatine phosphokinase/ creatine phosphokinase MB - which indicates sudden decreased blood flow to the heart muscle (shown in blood tests)
Maltese: • livelli għolja ta' creatine phosphokinase/creatine phosphokinase MB - li jindikaw tnaqqis f'daqqa tal-fluss tad-demm lejn il-muskolu tal-qalb (li jidhru fit-testijiet tad-demm)
English: • heart valve disorder (mitral valve incompetence)
Maltese: • disturb fil-valv tal-qalb (inkompetenza tal-valv mitrali)
English: Common adverse reactions reported with netupitant/palonosetron capsules were headache (3.6%), constipation (3.0%) and fatigue (1.2%).
Maltese: Reazzjonijiet avversi komuni rrappurtati b'kapsuli ta' netupitant/palonosetron kienu wġigħ ta' ras (3.6%), stitikezza (3.0%) u għeja (1.2%).
English: Table 2: Oral Antiemetic treatment regimen -- HEC study
Maltese: Tabella 2: Kors ta' kura Antiemetiku Orali -- Studju HEC
English: All patients were additionally treated with either doxorubicin (68.0%) or epirubicin (32.0%).
Maltese: Il-pazjenti kollha ġew ikkurati b'mod addizzjonali jew b'doxorubicin (68.0%) jew b'epirubicin (32.0%).
English: Approximately 62% of palonosetron is bound to plasma proteins.
Maltese: Madwar 62% ta' palonosetron jeħel mal-proteini tal-plażma.
English: The third major metabolite, M2, is > 97% bound to plasma proteins.
Maltese: It-tielet metabolit maġġuri, M2, jeħel f'ammont ta' > 97% mal-proteini tal-plażma.
English: Post-marketing data indicates that the adverse reactions profile is generally similar to that seen in clinical trials.
Maltese: Data miġbura wara t-tqegħid fis-suq tindika li l-profil tar-reazzjonijiet avversi huwa ġeneralment simili għal dak li deher fil-provi kliniċi.
English: In a separate study, a total of 413 patients undergoing initial and repeat cycles of chemotherapy (including carboplatin, cisplatin, oxaliplatin, and doxorubicin regimens), were randomized to receive either Akynzeo (n=309) or aprepitant and palonosetron (n=104).
Maltese: Fi studju separat, total ta' 413-il pazjent li kien qed ikollhom ċikli inizjali u ripetuti ta' kimoterapija (li jinkludu korsijiet ta' carboplatin, cisplatin, oxaliplatin, u doxorubicin), intgħażlu b'mod każwali biex jirċievu jew Akynzeo (n=309) jew aprepitant u palonosetron (n=104).
English: A total of 1450 patients (Akynzeo n=725; Palonosetron n=725) received study medication.
Maltese: Total ta' 1450 pazjent (Akynzeo n=725; Palonosetron n=725) irċivew il-medikazzjoni tal-istudju.
English: In 82 healthy subjects given a single oral dose of netupitant 300 mg, maximum plasma netupitant concentration (Cmax) was 486 ±268 ng/mL (mean ± SD) and median time to maximum concentration (Tmax) was 5.25 hours, the AUC was 15032 ± 6858 h.ng/mL.
Maltese: Fi 82 individwu b'saħħithom li ngħataw doża waħda orali ta' netupitant 300 mg, il-konċentrazzjoni massima ta' netupitant fil-plażma (Cmax) kienet ta' 486 ± 268 ng/mL (medja ± SD) u l-medjan tal-ħin sal-konċentrazzjoni massima (Tmax) kien ta' 5.25 sigħat, l-AUC kien ta' 15032 ± 6858 h.ng/mL.
English: Acute phase: 0 to 24 hours after anthracycline and cyclophosphamide regimen Delayed phase: 25 to 120 hours after anthracycline and cyclophosphamide regimen Overall: 0 to 120 hours after anthracycline and cyclophosphamide regimen
Maltese: Fażi akuta: 0 sa 24 siegħa wara l-kors ta' anthracycline u cyclophosphamide Fażi li tittardja: 25 sa 120 siegħa wara l-kors ta' anthracycline u cyclophosphamide Globali: 0 sa 120 siegħa wara l-kors ta' anthracycline u cyclophosphamide
English: Of these, 1438 patients (98.8%) completed cycle 1 and 1286 patients (88.4%) continued treatment in the multiple-cycle extension.
Maltese: Minn dawn, 1438 pazjent (98.8%) lestew ċiklu 1, u 1286 pazjent (88.4%) komplew il-kura estensjoni ta' ċikli multipli.
English: However, clinical pharmacokinetic parameters are not significantly different between poor and extensive metabolizers of CYP2D6 substrates.
Maltese: Madankollu, il-parametri farmakokinetiċi kliniċi mhumiex differenti b'mod sinifikanti bejn metabolizzaturi batuti u estensivi tas-substrati ta' CYP2D6.
English: Opaque gelatin capsule of size “0” (length 21.7 mm) with white body and caramel cap with “HE1” printed on the body.
Maltese: Kapsula ta' ġelatina opaka ta' daqs “0” (tul 21.7 mm) b'korp abjad u għatu lewn il-karamella b'“HE1” stampata fuq il-korp.
English: Netupitant/palonosetron capsules, when given with a single oral dose of 60 μg ethinylestradiol and 300 μg levonorgestrel had no significant effect on the AUC of ethinylestradiol and increased the AUC of levonorgestrel by 1.4-fold; clinical effects on the efficacy of hormonal contraception are unlikely.
Maltese: Kapsuli ta' netupitant/palonosetron, meta ngħataw ma' doża orali waħda ta' 60 μg ta' ethinylestradiol u 300 μg ta' levonorgestrel, ma kellhom l-ebda effett sinifikanti fuq l-AUC ta' ethinylestradiol, u żiedu l-AUC ta' levonorgestrel b'1.4 darbiet; effetti kliniċi fuq l-effikaċja ta' kontraċezzjoni ormonali mhumiex probabbli.
English: A risk to the suckling child cannot be excluded.
Maltese: Irriskju gћat-tarbija li tkun qed terda' mhux eskluż.
English: This medicine contains sucrose, sorbitol, sodium and may contain soya - see section 2 for more information.
Maltese: Din il-mediċina fiha sucrose, sorbitol, sodium u jista' jkun fiha s-sojja - ara sezzjoni 2 għal aktar informazzjoni.
English: - such as venlafaxine or duloxetine.
Maltese: noradrenaline) - bħal venlafaxine jew duloxetine.
English: Table 4: Oral Antiemetic treatment regimen - MEC study
Maltese: Tabella 4: Kors ta' kura Antiemetiku Orali - Studju MEC
English: • erythromycin - to treat bacterial infections
Maltese: • erythromycin - biex jikkura infezzjonijiet batterjali
English: Akynzeo 300 mg/0.5 mg hard capsules netupitant/palonosetron
Maltese: Akynzeo 300 mg/0.5 mg kapsuli ibsin netupitant / palonosetron
English: M1, M2 and M3 metabolites were all shown to be pharmacologically active in an animal pharmacodynamic model, where M3 was most potent and M2 least active.
Maltese: Intwera li lmetaboliti M1, M2 u M3 kienu kollha farmakoloġikament attivi f'mudell farmakodinamiku talannimali, fejn M3 kien l-iktar qawwi u M2 l-inqas attiv.
English: Netupitant/palonosetron capsules are unlikely to interact with medicinal products which are P-gp substrates.
Maltese: Il-kapsuli ta' netupitant/palonosetron mhux probabbli li jinteraġixxu ma' prodotti mediċinali li huma substrati ta' P-gp.
English: Netupitant is a moderate inhibitor of CYP3A4 and can increase the exposure of chemotherapeutic agents that are substrates for CYP3A4 e.g. docetaxel (see section 4.5).
Maltese: Netupitant hu inibitur moderat ta' CYP3A4 u jista' jżid l-esponiment ta' sustanzi kimoterapewtiċi li huma substrati għal CYP3A4, eż. docetaxel (ara sezzjoni 4.5).
English: Exposure to netupitant (Cmax, AUC0-t and AUC0-∞) compared to matching healthy subjects was 11%, 28% and 19% higher in mild and 70%, 88% and 143% higher in moderate hepaticallyimpaired subjects, respectively.
Maltese: L-esponiment għal netupitant (Cmax, AUC0-t u AUC0-∞) meta pparagunat ma' individwi f'saħħithom mqabbla, kien ta' 11%, 28% u 19% ogħla f'individwi b'indeboliment ħafif tal-fwied, u 70%, 88% u 143% ogħla f'individwi b'indeboliment moderat talfwied, rispettivament.
English: • ECG (electrocardiogram) problems (called ‘QT and PR interval prolongation', ‘conduction disorder', ‘tachycardia' and ‘atrioventricular block first degree')
Maltese: • problemi fl-ECG (elettrokardjogramma) (imsejħa ‘titwil tal-intervall tal-QT u PR', ‘disturb fil konduzzjoni', ‘takikardija' u ‘imblokk atrijoventrikulari tal-ewwel grad')
English: • The active substances are palonosetron and netupitant.
Maltese: • Is-sustanzi attivi huma palonosetron u netupitant.
English: Chemotherapeutic agents that are substrates for CYP3A4
Maltese: Sustanzi kimoterapewtiċi li huma substrati għal CYP3A4
English: • medicines with a narrow therapeutic range that are primarily metabolized by CYP3A4, such as cyclosporine, tacrolimus, sirolimus, everolimus, alfentanil, diergotamine, ergotamine, fentanyl,
Maltese: • mediċini b'firxa terapewtika dejqa li huma metabolizzati primarjament minn CYP3A4, bħal cyclosporine, tacrolimus, sirolimus, everolimus, alfentanil, diergotamine, ergotamine, fentanyl jew quinidine
English: Akynzeo contains two medicines (‘active substances') called:
Maltese: Akynzeo fiha żewġ mediċini (‘sustanzi attivi') li jisimhom:
English: At a dose of 300 mg in humans, netupitant is a substrate and moderate inhibitor of CYP3A4.
Maltese: F'doża ta' 300 mg fil-bnedmin, netupitant hu substrat u inibitur moderat ta' CYP3A4.
English: Constipation Abdominal distension
Maltese: Stitikezza Distensjoni addominali
English: Akynzeo 300 mg/0.5 mg hard capsules
Maltese: Akynzeo 300 mg/0.5 mg kapsuli ibsin
English: Uncommon (≥1/1,000 to <1/100),
Maltese: Mhux komuni (≥1/1,000 sa <1/100), Rari (≥1/10,000 sa <1/1,000),
English: In vitro data show that netupitant is a P-gp inhibitor.
Maltese: Dejta in vitro data turi li netupitant hu inibitur ta' P-gp.
English: There have also been reports of serotonin syndrome.
Maltese: Kien hemm ukoll rapporti ta' sindrome ta' serotonin.