FrancophonIA/ELRC3.0 huggingface dataset:
English: Arthralgia, arthritis, back pain, muscular weakness, musculoskeletal chest pain, musculoskeletal stiffness, neck pain, pain in extremity
Maltese: Artralġja, artrite, uġigħ fid-dahar, dgħjufija muskolari, uġigħ muskuloskeletali fis-sider, ebusija muskuloskeletali, uġigħ fl-għonq, uġigħ fl-estremitajiet
English: Aseptically withdraw the volume needed for the required dose (based on 5.8 mg/ml concentration) and transfer to a 250 ml infusion bag of sodium chloride 9 mg/ml (0.9%) solution for injection.
Maltese: Iġbed b'mod asettiku l-volum meħtieġ għad-doża meħtieġa (ibbażata fuq konċentrazzjoni ta' 5.8 mg/ml) u ttrasferixxi ġo borża ta' infużjoni ta' 250 ml ta' klorur tas-sodju 9 mg/ml (0.9%) ta' soluzzjoni għallinjezzjoni.
English: log rank p-value = 0.005 HR = 0.60 (95% CI 0.42, 0.86)
Maltese: (95% CI 0.42, 0.86)
English: Pixuvri belongs to a pharmacotherapeutic group of medicines known as ‘antineoplastic agents'.
Maltese: Pixuvri jappartjeni għal grupp ta' mediċini farmakoterapewtiċi magħrufa bħala ‘aġenti antineoplastiċi'.
English: Patients in PIX 301 were required to have been sensitive to prior anthracycline therapy (confirmed or unconfirmed CR or PR).
Maltese: Il-pazjenti f'PIX 301 riedu jkunu sensittivi għal terapija preċedenti b'antraċiklini (CR jew PR
English: The final concentration of pixantrone in the infusion bag should be less than 580 microgram /ml based upon input of reconstituted medicinal product.
Maltese: Il-konċentrazzjoni finali ta' pixantrone fil-borża tal-infużjoni għandha tkun inqas minn 580 mikrogramma /ml ibbażata fuq it-tidħil tal-prodott mediċinali rikostitwit.
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: • Rapporti Perjodiċi ta' Aġġornament dwar is-Sigurtà Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tadDirettiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: Vascular disorders
Maltese: tromboċitopenja
English: Pixuvri is not recommended for use in patients with severe excretory hepatic impairment, (see section 4.3).
Maltese: Pixuvri mhuwiex irrakkomandat għall-użu f'pazjenti b'indeboliment epatiku eskretali sever, (ara sezzjoni 4.3).
English: Comparator Agents
Maltese: Aġenti Komparaturi
English: The dose modifications should be considered (see section 4.2).
Maltese: Prodott, sezzjoni 4.2).
English: All initial treatment with Pixuvri should be preceded by a careful baseline assessment of blood counts, serum levels of total bilirubin, serum levels of total creatinine, and cardiac function as measured by left ventricular ejection fraction (LVEF).
Maltese: 4.4 Twissijiet speċjali u prekawzjonijiet għall-użu Kull kura inizjali b'Pixuvri għandha tkun preċeduta minn valutazzjoni bażika b'attenzjoni tal-għadd tad demm, tal-livelli tas-serum tal-bilirubina totali, tal-livelli tas-serum tal-kreatinina totali, u tal-funzjoni kardijaka kif imkejla permezz tal-frazzjoni ta' ħruġ ventrikolari tax-xellug (left ventricular ejection fractionLVEF).
English: Upon reconstitution and dilution, this medicinal product contains approximately 1g (43 mmol) sodium per dose, equivalent to 50% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Mar-rikostituzzjoni u d-dilwizzjoni, dan il-prodott mediċinali fih madwar 1g (43 mmol) sodju f'kull doża, ekwivalenti għal 50 % tat-teħid massimu ta' kuljum rakkomandat mill-WHO ta' 2 g sodju għal adult.
English: Pixuvri is used for the treatment of adult patients with multiply relapsed or refractory aggressive Non-Hodgkin Lymphomas.
Maltese: Pixuvri jintuża fil-kura ta' pazjenti adulti b'Limfomi Mhux Hodgkin aggressivi rikaduti jew refrattarji multipli.
English: Table 3 Adverse drug reactions reported related to Pixuvri in completed Pixuvri single agent studies by frequency System Organ Class
Maltese: Pixuvri fi studji kompluti b'Pixuvri b'aġent waħdieni skont ilfrekwenza Sistema tal-Klassifika tal-Organi
English: ANC count
Maltese: ANNESS III
English: Experience with pixantrone is limited to patients with LVEF ≥ 45% with most patients having values ≥ 50%.
Maltese: L-esperjenza b'pixantrone hija limitata għal pazjenti b'LVEF ≥ 45% bil-parti l-kbira tal-pazjenti jkollhom valuri ta' ≥ 50%.
English: < 1.0 - 0.5 x 109/l Delay treatment until recovery to platelet count ≥ 50 x 109/l and ANC** ≥ 1.0 x 109/l.
Maltese: ≥ 1.0 x 109/l u l-għadd tal-plejtlits għal ≥ 75 x 109/l.
English: In addition, caution should be taken when pixantrone is continuously co-administered with efflux transport inducers such as rifampicin, carbamazepin and glucocorticoids, as pixantrone excretion might be increased with a consequent decrease of systemic exposure.
Maltese: Barra minn hekk, għandha tintuża kawtela meta pixantrone jingħata kontinwament flimkien ma' indutturi tattrasport tal-effluss bħal rifampicin, carbamazepin u glukokortikojdi, minħabba li t-tneħħija ta' pixantrone tista' tiżdied b'konsegwenza ta' nuqqas ta' espożizzjoni sistemika.
English: Pack size of 1 vial.
Maltese: PAKKETT TA' BARRA
English: Blood and lymphatic system disorders*
Maltese: Disturbi tad-demm u tassistema limfatika *
English: Pixuvri caused maternal and foetal toxicity in rats and rabbits, even at a dose as low as 1.8 mg/kg given on days 9-11 of pregnancy, higher doses resulting in abortions and total embryo resorption.
Maltese: Pixuvri kkawża tossiċità għall-omm u għall-fetu fil-firien u fil-fniek, anki f'doża daqstant baxxa ta'1.8 mg/kg mogħtija fid-9-11-il jum ta' tqala, filwaqt li dożi akbar irriżultaw f'aborti u assorbiment totali tal-embriju.
English: After reconstitution, each ml of concentrate contains pixantrone dimaleate equivalent to 5.8 mg pixantrone.
Maltese: Wara r-rikostituzzjoni, kull ml ta' konċentrat fih pixantrone dimaleate ekwivalenti għal 5.8 mg pixantrone.
English: The reconstituted and diluted solution is stable for up to 24 hours at room temperature (15°C to 25°C) and daylight exposure in standard polyethylene (PE) infusion bags.
Maltese: Is-soluzzjoni rikostitwita u dilwita hija stabbli għal 24 siegħa f'temperatura ambjentali (15°C sa 25°C) u f'espożizzjoni għad-dawl tax-xemx f'boroż tal-infużjoni standard tal-polyethylene (PE).
English: Pixantrone had only a weak or no capability to inhibit P-gp, BCRP, and BSEP transport mechanism in vitro.
Maltese: Pixantrone kellu biss ftit jew xejn kapaċità li jinibixxi P-gp, BCRP, u l-mekkaniżmu ta' trasport BSEP in vitro.
English: The Fisher exact test was used to compare proportions in the Pixuvri and comparator chemotherapeutic groups.
Maltese: Intuża t-test ta' preċiżjoni Fisher sabiex jitqabblu l-proporzjonijiet fil-gruppi kemoterapewtiċi ta' Pixuvri u tal-komparatur
English: A comprehensive retrospective population PK/PD analysis of Phase 1 trials and combination regimens (Phase 1/2) demonstrated that progression-free survival and Grade 2-3 neutropenia were related to Pixuvri exposure.
Maltese: (Fażi 1/2) urew li s-sopravvivenza mingħajr progressjoni u n-newtropenja ta' Grad 2-3 kienu relatati mal espożizzjoni għal Pixuvri.
English: The recommended dose is 50 mg/m2 of pixantrone on days 1, 8, and 15 of each 28-day cycle for up to
Maltese: Id-doża rakkomandata hija 50 mg/m2 ta' pixantrone fl-ewwel, it-tmien u l-15-il jum ta' kull ċiklu ta' 28 jum sa mhux aktar minn 6 ċikli.
English: In 11 Pixuvri-treated patients, these events were grade 1-2 and in 2 patients they were grade 3; these events were transient and not Pixuvri dose related.
Maltese: Fi 11-il pazjent ikkurat b'Pixuvri, dawn l-avvenimenti kienu ta' grad 1-2 u f'żewġ pazjenti kienu ta' grad 3; dawn lavvenimenti kienu temporanji u mhux relatati mad-doża ta' Pixuvri.
English: somnolence
Maltese: Infezzjoni
English: Pixuvri was mutagenic in the Ames test, increased the number of chromosomal aberrations in human lymphocytes, and increased the frequency of micronuclei in vivo.
Maltese: Pixuvri kien mutaġeniku fit-test ta' Ames, żied l-għadd ta' aberazzjonijiet kromożomali fil limfoċiti tal-bniedem, u żied il-frekwenza ta' mikronuklei in vivo.
English: Type I glass vial with grey butyl rubber stopper with aluminium seal and red plastic cap containing 50 mg pixantrone dimaleate equivalent to 29 mg pixantrone.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Kunjett tal-ħġieġ tat-Tip I b'tapp griż tal-lastku butyl b'siġill tal-aluminju u għatu tal-plastik aħmar li fih 50 mg pixantrone dimaleate ekwivalenti għal 29 mg pixantrone.
English: Extravasation
Maltese: Assorbiment
English: Other medicines and Pixuvri
Maltese: Mediċini oħra u Pixuvri
English: READ ENTIRE PREPARATION INSTRUCTIONS PRIOR TO RECONSTITUTION
Maltese: AQRA L-ISTRUZZJONIJIET KOLLHA DWAR IL-PREPARAZZJONI QABEL IRRIKOSTITUZZJONI
English: Common Dyspnoea, cough Uncommon Pleural effusion, pneumonitis, rhinorrhoea
Maltese: Komuni ħafna Newtropenja, lewkopenja, limfopenja, anemija,
English: Blood uric acid levels, potassium, calcium phosphate, and creatinine should be evaluated after treatment in patients at high risk for tumour lysis (elevated LDH, high tumour volume, high baseline uric acid or serum phosphate levels).
Maltese: Il-livelli tal-aċidu uriku fid-demm, il-potassju, il-fosfat tal-kalċju, u l-kreatinina għandhom jiġu vvalutati wara l-kura f'pazjenti f'riskju għoli ta' lisi tat-tumur ((LDH għoli, volum għoli tat-tumur, livelli għoli tal-aċidu uriku bażiku jew tal-fosfat fis-serum).
English: Aseptically reconstitute each 29 mg vial with 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Maltese: Rikostituzzjoni u dilwizzjoni Irrikostitwixxi b'mod asettiku kull kunjett ta' 29 mg b'5 ml ta' klorur tas-sodju 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni.
English: In the clinical trial program, there has been one report of overdose with Pixuvri with no reported concomitant adverse events.
Maltese: Fil-programm tal-prova klinika, kien hemm rapport wieħed ta' doża eċċessiva b'Pixuvri bl-ebda avveniment avvers konkomitanti rrappurtat.
English: A baseline cardiac evaluation with a MUGA scan or an ECHO is recommended, especially in patients with risk factors for increased cardiac toxicity.
Maltese: Hija rrakkomandata valutazzjoni kardijaka bażika bi skan MUGA jew ECHO, b'mod speċjali f'pazjenti b'fatturi ta' riskju akbar ta' tossiċità kardijaka.
English: Pixantrone did inhibit OCT1-mediated metformin transport in vitro, but is not expected to inhibit OTC1 in vivo at clinically relevant concentrations.
Maltese: Pixantrone inibixxa t-trasport tal-metformin medjat minn OCT1 in vitro, iżda mhux mistenni li jinibixxi
English: Using sterile procedures, reconstitute each 29 mg vial with 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Maltese: Permezz ta' proċeduri sterili, irrikostitwixxi kull kunjett ta' 29 mg b'5 ml klorur tas-sodju 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni.
English: Patients treated with Pixuvri are likely to experience myelosuppression (neutropenia, leukopenia, anaemia, thrombocytopenia, and lymphopenia) with the predominant manifestation being neutropenia.
Maltese: (newtropenja, lewkopenja, anemija, tromboċitopenja, u limfopenja) bil-manifestazzjoni predominanti tkun in-newtropenja.
English: It appears as a dark blue powder which comes in vials containing 29 mg of pixantrone.
Maltese: Huwa trab blu skur li jiġi f'kunjetti li fihom 29 mg ta' pixantrone.
English: In vitro inhibition studies
Maltese: Studji ta' inibizzjoni in vitro
English: Common Erythema, nail disorder, pruritus Uncommon Night sweats, petechiae, rash macular, skin ulcer
Maltese: Għaraq bil-lejl, tbenġil, raxx makulari, ulċeri fil-ġilda
English: Bilirubin urine, blood phosphorus increased, blood urea increased, gamma-glutamyltransferase increased, neutrophil count increased, weight decreased
Maltese: Żieda tal-bilirubina fl-awrina, żieda fil-fosfru fid demm, żieda fl-urea tad-demm, żieda tal-gammaglutamyltransferase, żieda fl-għadd ta' newtrofili,
English: Warfarin is partially metabolised by CYP1A2, therefore, a theoretical concern exists with regard to co-administration of this medicinal product and the effect inhibition of its metabolism might have on its intended action.
Maltese: Warfarin huwa parzjalment metabolizzat permezz ta' CYP1A2, u għaldaqstant, jeżisti tħassib teoretiku fir rigward tal-għoti fl-istess waqt ta' dan il-prodott mediċinali u l-effett li l-inibizzjoni tal-metaboliżmu tiegħu jista' jkollha fuq l-azzjoni maħsuba tiegħu.
English: Amitriptyline, haloperidol, clozapine, ondansetron and propranolol are metabolised by CYP1A2, and therefore, a theoretical concern exists that co-administration of Pixuvri may increase blood levels of this medicinal product.
Maltese: Amitriptyline, haloperidol, clozapine, ondansetron u propranolol huma metabolizzati permezz ta' CYP1A2,
English: Effects on hepatic or renal function were minimal.
Maltese: L-effetti fuq il-funzjoni epatika jew renali kienu minimi.
English: However, in vitro, conversion of pixantrone into the acetylated metabolites by either NAT1 or NAT2 was very limited.
Maltese: Madankollu, in vitro, il konverżjoni ta' pixantrone fil-metaboliti aċetilati kemm permezz ta' NAT1 kif ukoll permezz ta' NAT2 kienet limitata ħafna.
English: Distribution Pixuvri has a large volume of distribution of 25.8 l and is approximately 50% bound to plasma proteins.
Maltese: 8 l u huwa madwar 50% marbut mal-proteini tal-plażma.
English: Pharmacotherapeutic group: Antineoplastic agents, anthracyclines, and related substances.
Maltese: Aġenti antineoplastiċi, antraċiklini, u sustanzi relatati Kodiċi ATC:
English: Pixuvri is given on days 1, 8, and 15 of each 28-day cycle for up to 6 cycles.
Maltese: Pixuvri jingħata fl-ewwel, fit-tmien u fil-15-il jum ta' kull ċiklu ta' 28 jum sa 6 ċikli.
English: As metabolism appears to be limited, biliary excretion of unchanged pixantrone may be the major elimination pathway.
Maltese: Minħabba li l-metaboliżmu jidher li huwa limitat, ittneħħija biljari ta' pixantrone mhux mibdul tista' tkun il-passaġġ ta' eliminazzjoni ewlenija.
English: Uncommon: may affect up to 1 in 100 people - severe infections such as septic shock, bronchitis, pneumonia, candidiasis, cellulitis, meningitis,
Maltese: infezzjonijiet severi bħal xokk settiku, bronkite, pulmonite, kandidjasi, ċellulite, meninġite,
English: There is currently no information on the safety and efficacy of patients with poor performance status (ECOG > 2).
Maltese: Fil-preżent m'hemm l-ebda informazzjoni dwar is-sigurtà u l-effikaċja ta' pazjenti bi status ta' rendiment batut (ECOG > 2).
English: The safety and efficacy of Pixuvri as single-agent therapy were evaluated in a multicentre, randomised, active controlled trial in patients with relapsed or refractory aggressive NHL after receiving at least two prior therapies.
Maltese: Is-sigurtà u l-effikaċja ta' Pixuvri bħala terapija b'aġent waħdieni kienu evalwati fi prova, aleatorja, u kkontrollata attiva f'diversi ċentri f'pazjenti b'NHL aggressiv rikadut jew refrattarju wara li rċevew millinqas żewġ terapiji preċedenti (PIX301).
English: Use gloves, masks, and protective eyewear when handling and during decontamination procedures.
Maltese: Uża ingwanti, maskri, u nuċċali ta' protezzjoni meta tużah u waqt il-proċeduri ta' dekontaminazzjoni.
English: This effect has not been evaluated in humans.
Maltese: Tista' tieħu infezzjoni aktar faċilment wara li tkun ingħatajt Pixuvri.
English: - taste disturbances - abnormal sensations of the skin such as numbness, tingling, pricking (paraesthesia) - headache - sleepiness - tiredness - inflammation of the eyes (conjunctivitis) - diarrhoea - pain in the abdomen - inflammation and/or ulceration of the throat and the mouth - dry mouth, constipation, indigestion, loss of appetite - skin changes such as redness and itching of the skin, nail changes - damage to the heart, decrease in heart's ability to pump blood, blockage of electrical signals in your heart, uneven or fast heartbeat.
Maltese: dijarea uġigħ fl-addome infjammazzjoni u/jew ulċeri fil-gerżuma u fil-ħalq nixfa fil-ħalq, stitikezza, indiġestjoni, nuqqas ta' aptit bidliet fil-ġilda bħal ħmura u ħakk fil-ġilda, bidliet fid-dwiefer ħsara lill-qalb, tnaqqis fl-abbiltà tal-qalb li tippompja d-demm, imblukkar ta' sinjali elettriċi f'qalbek, taħbit tal-qalb irregolari jew mgħaġġel.
English: - if you have very severe liver problems.
Maltese: - jekk għandek problemi serji ħafna tal-fwied.
English: Any grade 3 or 4 NYHA* cardiovascular toxicity or persistent LVEF** decline
Maltese: NYHA* jew tnaqqis persistenti f'LVEF**
English: Elderly
Maltese: Gidy
English: For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara r-rikostituzzjoni u d-dilwizzjoni tal-prodott mediċinali, ara sezzjoni 6.3. 6.5
English: Patient demographics and baseline disease characteristics were well balanced between the treatment groups, and no statistically significant differences were noted.
Maltese: Id-demografija tal-pazjenti u l-karatteristiċi bażiċi tal-mard kienu bbilanċjati tajjeb bejn il-gruppi kkurati, u ma kienet innotata l-ebda differenza statistikament sinifikanti.
English: Common Anorexia, hypophosphataemia Uncommon Hyperuricaemia, hypocalcaemia, hyponatraemia,
Maltese: Iperurikemija, ipokalċemija, iponatremija,
English: Three Pixuvri patients (4.4%) had tachycardia, arrhythmia, sinus tachycardia, supraventricular tachycardia or bradycardia.
Maltese: arritmija, takikardija tas-sinus, takikardija supraventrikulari jew bradikardija.
English: oedema
Maltese: KUNJETT
English: Table 1 and Table 2 are recommended as guides to dosage adjustments for days 8 and 15 of the 28- day cycles.
Maltese: It-Tabella 1 u t-Tabella 2 huma rrakkomandati bħala gwidi għall-aġġustamenti tad-doża għat-8 u l-15-il jum taċ-ċikli ta' 28 jum.
English: Common Left ventricular dysfunction, cardiac disorder, cardiac failure congestive, bundle branch block, tachycardia Uncommon Arrhythmia
Maltese: insuffiċjenza konġestiva tal-qalb, imblukkar tal-bundle branch, takikardija
English: cysts and polyps)
Maltese: hawn taħt).
English: Using sterile procedures, withdraw the volume needed for the required dose (based on 5.8 mg/ml concentration) and further dilute with sodium chloride 9 mg/ml (0.9%) solution for injection to a final volume of 250 ml.
Maltese: 5.8 mg/ml) u kompli ddilwixxi bi klorur tas-sodju 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni sa volum finali ta' 250 ml.
English: Pixuvri must be administered by physicians who are familiar with the use of antineoplastic agents and have the facilities for regular monitoring of clinical, haematological, and biochemical parameters during and after treatment (see section 6.6).
Maltese: Pixuvri għandu jingħata minn tobba li jafu jużaw l-aġenti antineoplastiċi u li għandhom il-faċilitajiet għallmonitoraġġ regolari tal-parametri kliniċi, ematoloġiċi u bijokimiċi waqt u wara l-kura (ara sezzjoni 6.6).
English: - Hypersensitivity to pixantrone dimaleate, or to any of the excipients listed in section 6.1 - Immunisation with live virus vaccines - Profound bone marrow suppression - Severe abnormal hepatic function.
Maltese: - Sensittività eċċessiva għal pixantrone dimaleate, jew għal kwalunkwe sustanza mhux attiva elenkata fis sezzjoni 6.1
English: Patients with impaired hepatic function
Maltese: Pazjenti b'indeboliment tal-funzjoni epatika
English: Use gloves, masks, and protective eyewear when handling Pixuvri and during decontamination procedures.
Maltese: Uża ingwanti, maskri, u nuċċali ta' protezzjoni meta tuża Pixuvri u waqt il-proċeduri ta' dekontaminazzjoni.
English: Due to this unique structure, pixantrone produced minimal cardiotoxicity in animal models compared with doxorubicin or mitoxantrone.
Maltese: Minħabba din l-istruttura unika, pixantrone ipproduċa kardjotossiċità minima fil-mudelli tal annimali meta mqabbel ma' doxorubicin jew mitoxantrone.
English: Coagulation parameters, specifically international normalised ratio (INR), should be monitored in the days immediately following the initiation of Pixuvri concurrent therapy.
Maltese: Il-parametri ta' koagulazzjoni, b'mod speċifiku l-proporzjon normalizzat internazzjonali (INR), għandhom ikunu ssorveljati fil-jiem immedjatament wara l-bidu tat terapija fl-istess waqt b'Pixuvri.
English: Although a risk to inhibition of pixantrone towards CYP2C8 could not be ascertained, caution should be observed when co-administering substances that are primarily metabolised via CYP2C8, such as repaglinide, rosiglitazone, or paclitaxel e.g. by careful monitoring for side effects.
Maltese: Għalkemm ir-riskju ta' inibizzjoni ta' pixantrone għal CYP2C8 ma setax ikun żgurat, għandha tintuża kawtela meta wieħed jagħti fl-istess waqt sustanzi li jkunu primarjament metabolizzati permezz ta' CYP2C8, bħal repaglinide, rosiglitazone, jew paclitaxel eż. permezz ta' monitoraġġ bir-reqqa għall-effetti sekondarji.
English: Skin and subcutaneous tissue disorders*
Maltese: Disturbi fil-ġilda u fit-tessuti ta'
English: Pixantrone may induce hyperuricaemia as a consequence of the extensive purine catabolism that accompanies drug-induced rapid lysis of neoplastic cells (tumour lysis syndrome) and can lead to electrolyte imbalances, which can result in kidney damage.
Maltese: Pixantrone jista' jikkawża iperuriċemija b'konsegwenza tal-kataboliżmu estensiv tal-purina li jakkumpanja llisi rapida ta' ċelloli neoplastiċi kkawżata mill-mediċina (sindrome tal-lisi tat-tumur) u jista' jwassal għal żbilanċ fl-elettroliti, li jista' joħloq ħsara fil-kliewi.
English: Immunisation with live virus vaccines is contraindicated due to the immunosuppression associated with Pixuvri therapy (see section 4.3).
Maltese: It-tilqim b'virusijiet ħajjin mhuwiex indikat minħabba l-immunosoppressjoni assoċjata mat-terapija b'Pixuvri (ara sezzjoni 4.3).
English: The safety and efficacy of Pixuvri in children aged < 18 years has not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Pixuvri fit-tfal ta' inqas minn 18-il sena ma ġewx determinati s'issa.
English: Very common Chromaturia
Maltese: Komuni ħafna Kromaturja Komuni
English: Pixuvri may be metabolised in the liver and/or excreted in the bile.
Maltese: Pixuvri jista' jkun metabolizzat fil-fwied u/jew imneħħi fil-bili.
English: Common Proteinuria, haematuria Uncommon Oliguria
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: dry mouth, dyspepsia,
Maltese: Nuqqas ta' mudullun, esinofilja
English: In dogs, Pixuvri given at 0.5 to 0.9 mg/kg for six cycles did not cause mortality or severe clinical signs, including ECG or body weight changes.
Maltese: Fil-klieb, Pixuvri mogħti f'0.5 sa 0.9 mg/kg għal sitt ċikli ma kkawżax mewt jew sinjali kliniċi severi, inklużi bidliet fl-ECG jew fil-piż tal-ġisem.
English: How Pixuvri is given
Maltese: Pixuvri ma' ikel u xorb
English: Uncommon Vertigo
Maltese: TAGĦRIF
English: Blood counts should be closely monitored when co-administered with agents which inhibit such transporters such as cyclosporine A or tacrolimus, commonly used to control chronic graft-versus-host disease, and the anti-HIV agents ritonavir, saquinavir, or nelfinavir.
Maltese: mard kroniku tat-trapjant kontra l-ospitant, u l-aġenti ta' kontra l-HIV ritonavir, saquinavir, jew nelfinavir.
English: Description of selected adverse reactions
Maltese: Deskrizzjoni ta' reazzjonijiet avversi partikolari
English: One vial contains 39 mg sodium.
Maltese: Kunjett wieħed fih 39 mg sodju.
English: Invented name Strength Pharmaceutical Form Route of administration
Maltese: Numru ta' l-EU Isem inventat Qawwa Gamla farmaewtika
English: Content (concentration) Package size
Maltese: Kontenut (konentrazzjoni) Daqs tal-pakkett
English: 120 capsules
Maltese: 120 kapsula
English: Capsule, soft bottle (HDPE)
Maltese: Kapsula, ratba flixkun (HDPE)
English: Oral solution bottle (glass)
Maltese: Soluzzjoni orali flixkun (ħġieġ)
English: Invented name Strength Pharmaceutical Form Route of Administration Packaging Content
Maltese: Kontenut Daqs tal-pakkett
English: Package size
Maltese: Għamla farmaċewtika