FrancophonIA/ELRC3.0 huggingface dataset:
English: In AML and ASM, SM-AHN and MCL patients, population pharmacokinetic estimates for clearance of midostaurin at steady state were 5.9 l/h and 4.4 l/h, respectively.
Maltese: F'pazjenti b'AML u ASM, SM-AHN u MCL, l-istimi tal-farmakokinetiċi tal popolazzjoni għat-tneħħija ta' midostaurin fi stat fiss kienu ta' 5.9 l/h u 4.4 l/h, rispettivament.
English: In vitro evaluation of drug-drug interaction potential
Maltese: Evalwazzjoni in vitro tal-potenzjal ta' interazzjoni bejn mediċina u oħra
English: The most frequent Grade 3/4 ADRs were febrile neutropenia (83.5%), lymphopenia (20.0%), device-related infection (15.7%), exfoliative dermatitis (13.6%), hyperglycaemia (7.0%) and nausea (5.8%).
Maltese: L-aktar ADRs frekwenti fi Grad 3/4 kienu newtropenja febbrili (83.5%), limfopenija (20.0%), infezzjoni minħabba t-tagħmir użat (15.7%), dermatite esfoljattiva (13.6%), ipergliċemija (7.0%) u dardir (5.8%).
English: Females 95% CI
Maltese: Rġiel 95% CI
English: MIDOSTAURIN - SCT PLACEBO - SCT MIDOSTAURIN - no SCT PLACEBO - no SCT
Maltese: MIDOSTAURIN - SCT PLAĊEBO - SCT MIDOSTAURIN - l-ebda SCT PLAĊEBO - l-ebda SCT
English: For EFS, considering complete remissions within 60 days of study treatment start, the HR was 0.602 (95% CI: 0.372, 0.974) for patients with SCT and 0.827 (95% CI: 0.689, 0.993) for patients without SCT, favouring midostaurin.
Maltese: Għal EFS, meta jitqiesu r-remissjonijiet sħaħ fi żmien 60 jum mit-tnedija tal-istudju dwar it-trattament, l-HR kien 0.602 (95% CI: 0.372, 0.974) għal pazjenti b'SCT u 0.827 (95% CI: 0.689, 0.993) għal pazjenti mingħajr SCT, li jiffavorixxi midostaurin.
English: Two major metabolites have been identified in murine models and humans, i.e. CGP62221 and CGP52421.
Maltese: Ġew identifikati żewġ metaboliti ewlenin f'mudelli murini u fil-bnedmin, i.e. CGP62221 u CGP52421.
English: In addition, midostaurin inhibits several other receptor tyrosine kinases such as PDGFR (platelet-derived growth factor receptor) or VEGFR2 (vascular endothelial growth factor receptor 2), as well as members of the serine/threonine kinase family PKC (protein kinase C).
Maltese: Barra minn hekk, midostaurin jinibixxi bosta riċetturi oħrajn tat-tyrosine kinase fosthom PDGFR (riċettur tal-fattur tat-tkabbir derivat mill-plejtlits) jew il-VEGFR2 (riċettur 2 tal-fattur tat-tkabbir talendoteljali vaskulari), kif ukoll membri tal-familja ta' serine/threonine kinase PKC (proteina tal-kinasi C).
English: Final CSR: June 2023
Maltese: Ġunju 2023
English: On day 1, the AUC0-12 and Cmax were 8130 ng*h/ml and 1206 ng/ml, respectively, for healthy subjects.
Maltese: Fl-1 ġurnata, l-AUC0-12 u s-Cmax kienu 8130 ng*h/ml u 1206 ng/ml, rispettivament, għal suġġetti b'saħħithom.
English: Forty-six percent of patients had a decrease in bone marrow infiltration that exceeded 50% and 58% had a decrease in serum tryptase levels that exceeded 50%.
Maltese: Sitta u erbgħin fil-mija tal-pazjenti kellhom tnaqqis fl-infiltrazzjoni tal-mudullun li qabżet il-50% u 58% kellhom tnaqqis fil-livelli tat-triptasi tas-serum li qabeż il-50%.
English: Cytochrome P450 induction
Maltese: Inibizzjoni taċ-ċitokromu P450
English: The most frequent Grade 3/4 ADRs were fatigue (8.5%), sepsis (7.7%), pneumonia (7%), febrile neutropenia (7%), and diarrhoea (6.3%).
Maltese: L-aktar ADRs frekwenti bi Grad 3/4 kienu għeja (8.5%), sepsis (7.7%), pnewmonja (7%), newtropenja bid-deni (7%) u dijarrea (6.3%).
English: Strong CYP3A4 inducers decrease exposure of midostaurin and its active metabolites (CGP52421 and CGP62221).
Maltese: Indutturi qawwija ta' CYP3A4 jnaqqsu l-espożizzjoni ta' midostaurin u tal-metaboliti attivi tiegħu (CGP52421 u CGP62221).
English: Absolute lymphocyte decreased*
Maltese: Tnaqqis tal-limfoċiti assoluti*
English: Oral herpes
Maltese: Erpite orali
English: The dimensions of the capsule are approximately 25.4 x 9.2 mm.
Maltese: x 9.2 mm.
English: The overall median duration of exposure was 42 days (range 2 to 576 days) for patients in the Rydapt plus standard chemotherapy arm versus 34 days (range 1 to 465 days) for patients in the placebo plus standard chemotherapy arm. For the 205 patients (120 in Rydapt arm and 85 in placebo arm) who entered the maintenance phase, the median duration of exposure in maintenance was 11 months for both arms (16 to 520 days for patients in the Rydapt arm and 22 to 381 days in the placebo arm).
Maltese: Għall-205 pazjenti (120 fil-grupp mogħti Rydapt u 85 filgrupp mogħti l-plaċebo) li ssieħbu fil-fażi ta' manutenzjoni, it-tul ta' żmien medjan ta' espożizzjoni waqt il-manutenzjoni kien ta' 11-il xahar għaż-żewġ gruppi (16 sa 520 jum għall-grupp mogħti Rydapt u ta' 22 sa 381 jum għall-grupp mogħti l-plaċebo).
English: The most frequent (incidence ≥1%) were febrile neutropenia, nausea, vomiting and pleural effusion.
Maltese: L-aktar frekwenti (inċidenza ta' ≥1%) kienu newtropenja febbrili, dardir, rimettar u effużjoni plewrali.
English: Because of the potential for serious adverse reactions in breast-feeding infants from Rydapt, women should discontinue breast-feeding during treatment with Rydapt and for at least 4 months after stopping treatment (see section 4.6).
Maltese: Minħabba li jista' jkun hemm reazzjonijiet avversi fi trabi mreddgħa minħabba Rydapt, in-nisa għandhom jieqfu jreddgħu matul it-trattament b'Rydapt u għal mill-inqas 4 xhur wara li jitwaqqaf ittrattament (ara sezzjoni 4.6).
English: The median duration of exposure to Rydapt was 11.4 months (range: 0 to 81 months).
Maltese: Iddewmien medju tal-espożizzjoni għal Rydapt kien ta' 11.4 xhur (firxa: minn 0 sa 81 xahar).
English: Based on in vitro data, midostaurin and/or its metabolites have the potential to induce CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 and CYP3A4/5 enzymes.
Maltese: Skont dejta in vitro, midostaurin u/jew il-metaboliti tiegħu għandhom il-potenzjal li jinduċu l-enzimi CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, u CYP3A4/5.
English: The most frequent Grade 3/4 laboratory abnormalities were absolute lymphocyte count decreased (45.8%), ANC decreased (26.8%), hyperglycaemia (19%), and lipase increased (17.6%).
Maltese: Laktar anormalitajiet frekwenti bi Grad 3/4 li dehru fil-laboratorju kienu t-tnaqqis tal-ammont assolut ta' limfoċiti (45.8%), u tnaqqis tal-ANC (26.8%), ipergliċemija (19%), u żieda tal-lipase (17.6%).
English: Rydapt is also used in adults to treat aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM-AHN), or mast cell leukaemia (MCL).
Maltese: Rydapt jintuża wkoll f'adulti biex jittrattaw marda msejħa mastoċitożi sistemika aggressiva (ASM), mastoċitożi sistemika b'neoplażma ematoloġika assoċjata (SM-AHN), jew lewkimja tal-mast cell (MCL).
English: Safety pharmacology studies indicate that midostaurin is unlikely to interfere with vital functions of the central nervous system.
Maltese: Studji farmakoloġiċi dwar is-sigurtà jindikaw li midostaurin ma jidhirx li se jinterferixxi ma' funzjonijiet vitali tas-sistemi nervużi respiratorji u ċentrali.
English: The combination of data on in vivo midostaurin auto-induction upon repeated dosing and increase in plasma 4β-OH cholesterol levels suggest that midostaurin may be at least a moderate CYP3A4 inducer in vivo.
Maltese: It-tlaqqigħ ta' dejta minn midostaurin in vivo awtoinduzzjoni wara doża ripetuta u żieda fil-livelli ta' kolesterol 4β-OH fil-plażma jissuġerixxi li midostaurin jista' jkun tal-inqas induttur moderat ta' CYP3A4 in vivo.
English: Overall 95% CI
Maltese: Globali 95% CI
English: A dedicated hepatic impairment study assessed the systemic exposure of midostaurin after oral administration of 50 mg twice daily for 6 days in subjects with baseline mild or moderate hepatic impairment (Child-Pugh Class A or B, respectively) and control subjects with normal hepatic function.
Maltese: Studju ddedikat għall-indeboliment tal-fwied evalwa l-espożizzjoni sistemika ta' midostaurin wara lgħoti mill-ħalq ta' 50 mg darbtejn kuljum għal 6 ijiem f'suġġetti b'indeboliment epatiku ħafif jew moderat fil-linja bażi (Child-Pugh A jew B, rispettivament) u f'suġġetti ta' kontroll b'funzjoni epatika normali.
English: On day 7, AUCCtrough (exposure under the curve of Ctrough from day 1 to day 7) was 5410 ng*h/ml in healthy subjects and was decreased by 35% and 20% in subjects with mild and moderate hepatic impairment, respectively.
Maltese: Fis-7 jum, l-AUCCtrough (espożizzjoni taħt il-kurva ta' Ctrough mill-1 jum sas-7 jum) kien 5410 ng*h/ml f'suġġetti b'saħħithom u niżel b'35% u 20% f'suġġetti b'ideboliment epatiku ħafif u moderat, rispettivament.
English: Caution is warranted in patients at risk of QTc prolongation (e.g. due to concomitant medicinal products and/or electrolyte disturbances).
Maltese: Hija meħtieġa attenzjoni f'pazjenti b'riskju ta' titwil QTc (eż. minħabba prodotti mediċinali konkomitanti u/jew disturbi flelettroliti).
English: 9/l, then resume at 50 mg twice daily.
Maltese: 9/l, u wara ssokta b'50 mg darbtejn kuljum.
English: The primary endpoint was overall response rate (ORR).
Maltese: L-endpoint primarju kien ir-rata globali ta' rispons (ORR).
English: Rydapt 25 mg soft capsules midostaurin
Maltese: Rydapt 25 mg kapsuli rotob midostaurin
English: Response to Rydapt was determined using a computational algorithm applied without any adjudication.
Maltese: Ir-rispons għal Rydapt kien iddeterminat permezz ta' algoritmu ta' komputazzjoni applikat mingħajr ebda aġġudikazzjoni.
English: Single doses of up to 600 mg have been given with acceptable acute tolerability.
Maltese: Ingħataw dożi singoli sa 600 mg b'tollerrabbiltà akuta aċċettabbli.
English: The most frequent Grade 3/4 adverse reaction leading to discontinuation in the Rydapt arm was exfoliative dermatitis (1.2%).
Maltese: L-aktar reazzjoni avversa frekwenti fi Grad 3/4 li wasslet għat-twaqqif għal kollox fil-grupp mogħti Rydapt kienet id-dermatite esfoljattiva (1.2%).
English: - The other ingredients are: macrogolglycerol hydroxystearate, gelatin, macrogol, glycerol, ethanol anhydrous, maize oil mono-di-triglycerides, titanium dioxide (E171), all-rac-alpha-tocopherol, iron oxide yellow (E172), iron oxide red (E172), carmine (E120), hypromellose, propylene glycol, purified water.
Maltese: all-rac-alpha-tocopherol, iron oxide yellow (E172), iron oxide red (E172), carmine (E120),
English: Soft capsule (capsule).
Maltese: GĦAMLA FARMAĊEWTIKA Kapsula ratba (kapsula).
English: Nausea, vomiting and diarrhoea were observed in AML, ASM, SM-AHN and MCL patients.
Maltese: Dardir, rimettar u dijarea kienu osservati f'pazjenti AML, ASM, SM-AHN u MCL.
English: Stable disease, n (%) Progressive disease, n
Maltese: Rispons parzjali, n (%) Mard stabbli, n (%) Mard progressiv, n (%) Endpoints sekondarji
English: Discontinue Rydapt if low ANC persists for >21 days and is suspected to be related to Rydapt.
Maltese: Waqqaf Rydapt jekk ANC baxx jippersisti għal >21 jum u huwa ssuspettat li huwa relatat ma' Rydapt.
English: No impact of hepatic impairment could be identified in patients with mild or moderate hepatic impairment in the ASM, SM-AHN, MCL and AML populations.
Maltese: Ma setax jiġi identifikat impatt mill-indeboliment epatiku f'pazjenti b'indeboliment epatiku minn ħafif sa moderat fil-popolazzjoni b'ASM, SM-AHN, MCL u b'AML.
English: There are no differences in the pharmacokinetic profile between Caucasian and Black subjects.
Maltese: M'hemmx differenzi fil-profil farmakoknetiku bejn suġġetti Kawkażjatiċi u Suwed.
English: Renal elimination is a minor route of elimination for midostaurin.
Maltese: Ma sarx studju iddedikat lillindeboliment renali għal midostaurin.
English: Investigations Haemoglobin decreased*
Maltese: Investigazzjonijiet Tnaqqis tal-emoglobina*
English: Overall survival probability, %
Maltese: Globali %
English: In a study with 36 healthy subjects, co-administration of the strong CYP3A4 inhibitor ketoconazole to steady state with a single dose of 50 mg midostaurin led to a significant increase in midostaurin exposure (1.8-fold Cmax increase and 10-fold AUCinf increase) and 3.5-fold increase in AUCinf of CGP62221, while the Cmax of the active metabolites (CGP62221 and CGP52421) decreased by half (see section 5.2).
Maltese: Fi studju b'36 suġġett b'saħħithom, l-għoti tal-inibitur qawwi CYP3A4 ketoconazole fi stat fiss flimkien ma' doża singola ta' 50 mg midostaurin wassal għal żieda qawwija fl-espożizzjoni ta' midostaurin (żieda tas-Cmax ta' 1.8 darba u żieda tal- AUCinf b'10 darbiet) u żieda tal-AUCinf ta' CGP62221 bi 3.5 drabi, filwaqt li s-Cmax tal-metaboliti attivi (CGP62221 u CGP52421) niżlu bin-nofs (ara sezzjoni 5.2).
English: Dizziness
Maltese: Sinużite
English: median (95% CI)
Maltese: medjan (95% CI)
English: Clinical experience in patients with severe renal impairment is limited and no data are available in patients with end-stage renal disease (see sections 4.4 and 5.2).
Maltese: Lesperjenza klinika f'pazjenti b'indeboliment tal-kliewi sever hi limitata u ma teżistix dejta għal pazjenti b'mard tal-kliewi fl-aħħar stadju (ara sezzjonijiet 4.4 u 5.2).
English: N=72
Maltese: N=72 N=21
English: Midostaurin in combination with chemotherapeutic agents (cytarabine, doxorubicin, idarubicin and daunorubicin) resulted in synergistic growth inhibition in FLT3-ITD expressing AML cell lines.
Maltese: Midostaurin flimkien ma' aġenti kimoterapewtiċi (cytarabine, doxorubicin, idarubicin u daunorubicin) wassal għal inibizzjoni tat-tkabbir sinerġistiku f'linji ċellulari AML li jesprimu FLT3-ITD.
English: In the ASM, SM-AHN and MCL population, 25.4% of patients had at least one ECG measurement with a QTcF greater than 450 ms and 4.7% greater than 480 ms.
Maltese: 4% tal-pazjenti kellhom mill-inqas kejl wieħed bl-ECG bi QTcF akbar minn 450 ms u 4.7% akbar minn 480 ms.
English: ANC decreased*
Maltese: Tnaqqis tal-ANC*
English: The safety of Rydapt (100 mg twice daily) as a single agent in patients with ASM, SM-AHN and MCL was evaluated in 142 patients in two single-arm, open-label, multicentre studies.
Maltese: Is-sigurtà ta' Rydapt (100 mg darbtejn kuljum) bħala aġent waħdieni f'pazjenti b'ASM, SM-AHN u MCL kienet evalwata f'142 pazjent waqt studji b'żewġ gruppi singoli, open-label u multiċentriċi.
English: The most frequent Grade 3/4 laboratory abnormalities were ANC decreased (85.8%), haemoglobin decreased (78.5%), ALT increased (19.4%) and hypokalaemia
Maltese: L-aktar anormalitajiet frekwenti fil-laboratorju fi Grad 3/4 kienu tnaqqis fl-ANC (85.8%), tnaqqis fl-emoglobina (78.5%), żieda fl-ALT (19.4%) u ipokalemija (13.9%).
English: In a study in healthy subjects, co-administration of the strong CYP3A4 inducer rifampicin (600 mg daily) to steady state with a 50 mg single dose of midostaurin decreased midostaurin Cmax by 73% and AUCinf by 96% on average, respectively.
Maltese: Waqt studju fost suġġetti b'saħħithom l-għoti flimkien talinduttur qawwi CYP3A4 rifampicin (600 mg kuljum) fi stat fiss flimkien ma' doża waħda ta' 50 mg midostaurin bis-Cmax ta' midostaurin imnaqqas bi 73% u l-AUCinf b'96% bħala medja, rispettivament.
English: Severe neutropenia (ANC <0.5 x 10
Maltese: Normalment każijiet ta' newtropenja severa (ANC <0.5 x 10
English: Capsule content
Maltese: Il-kontenut tal-kapsula
English: Approximately one third (36%) received prior anti-neoplastic therapy for ASM, SM-AHN or MCL.At baseline in the primary efficacy population, 65% of the patients had >1 measurable C finding (thrombocytopenia, hypoalbuminaemia, anaemia, high total bilirubin, transfusion-dependent anaemia, weight loss, neutropenia, high ALT or high AST).
Maltese: Fil-linja bażi fil-popolazzjoni li tivverifika leffikaċja primarja, 65% tal-pazjenti kellhom sejba C li tista' titkejjel ta' >1 (tromboċitopenija, ipoalbuminemija, anemija, l-ammont sħiħ ta' bilirubina għoli, anemija dipendenti minn trasfużjoni, telf ta' piż, newtropenja, ALT għoli jew AST għoli).
English: Patients were stratified by FLT3 mutation status: TKD, ITD with allelic ratio <0.7, and ITD with allelic ratio ≥0.7.
Maltese: TKD, ITD bi proporzjon allelika ta' <0.7, u b'ITD bi proporzjon allelika ta' ≥0.7.
English: Tell your doctor or pharmacist if you are taking any of the following medicines: - some medicines used to treat infections, such as ketoconazole or clarithromycin; - some medicines used to treat HIV, such as ritonavir or efavirenz; - nefazadone, a medicine used to treat depression; - some medicines used to stop the body from rejecting organ transplants, such as tacrolimus; - some medicines used to treat cancer, such as paclitaxel or cyclophosphamide; - some medicines used to control levels of fat in your blood, such as atorvastatin; - digoxin, a medicine used to treat heart failure; - warfarin, a medicine used to treat and prevent thrombosis; - tizanidine, a medicine used to relax muscles; - codeine, a medicine used to treat pain; - omeprazole, a medicine to treat excessive stomach acid, ulcers and heartburn; - chlorzoxazone, a medicine used for treating discomfort caused by muscle spasms.
Maltese: Għid lit-tabib jew l-ispiżjar tiegħek jekk qed tieħu xi waħda minn dawn il-mediċini: - xi mediċini użati biex jittrattaw infezzjonijiet, bħal ketoconazole jew clarithromycin; - xi mediċini użati biex jittrattaw l-HIV, bħal ritonavir jew efavirenz; - nefazadone, mediċina użata biex tittratta d-dipressjoni; - xi mediċini użati biex iwaqqfu l-ġisem milli jirriġetta trapjanti ta' organi, bħal tacrolimus - xi mediċini użati biex jittrattaw il-kankru, bħal paclitaxel jew cyclophosphamide; - xi mediċini użati biex jikkontrollaw il-livelli ta' xaħam fid-demm tiegħek, bħal atorvastatin; - digoxin, mediċina użata biex tittratta l-insuffiċjenza tal-qalb; - warfarin, mediċina użata biex tittratta u tipprevjeni trombożi; - tizanidine, mediċina użata biex tirrilassa l-muskoli; - codeine, mediċina użata biex tittratta l-uġigħ; - omeprazole, mediċina li tittratta l-aċidu żejjed fl-istonku, l-ulċeri u l-ħruq ta' stonku; - chlorzoxazone, mediċina użata biex tittratta skumdità kkawżata minn spażmi fil-muskoli.
English: The most frequent serious ADR in both arms was febrile neutropenia (16%).
Maltese: L-aktar ADR serju frekwenti fiż-żewġ gruppi kienet in-newtropenja febbrili (16%).
English: In vivo studies have not been conducted for the investigation of induction and inhibition of enzymes and transporters by midostaurin and the active metabolites.
Maltese: Ma twettqux studji in vivo għall-investigazzjoni ta' induzzjoni u inibizzjoni tal-enzimi u t-trasportaturi b'midostaurin u l-metaboliti attivi.
English: Disease Free Survival (DFS)
Maltese: Ħielsa minn kull Mard (DFS)
English: Based on population pharmacokinetic analyses no significant impact of age on the pharmacokinetics of midostaurin and its two active metabolites was identified for patients aged between 65 and 85 years.
Maltese: Skont analiżi tal-farmakokinetiku tal-popolazzjoni ma kienx identifikat impatt sinifikanti tal-età fuq ilfarmakokinetiċi ta' midostaurin u taż-żewġ metaboliti tiegħu għal pazjenti li kellhom bejn 65 u 85 sena.
English: In ASM, SM-AHN and MCL patients these events led to dose adjustment or interruption in 26% and to discontinuation in 4.2% of the patients.
Maltese: F'pazjenti ASM, SM-AHN u MCL, dawn l-avvenimenti wasslu għal aġġustament jew interruzzjoni fid-doża f'26% u għal twaqqif f'4.2% tal-pazjenti.
English: The most frequent adverse drug reactions (ADRs) in the Rydapt arm were febrile neutropenia (83.4%), nausea (83.4%), exfoliative dermatitis (61.6%), vomiting (60.7%), headache (45.9%), petechiae (35.8%) and pyrexia (34.5%).
Maltese: L-iktar reazzjonijiet avversi komuni tal-mediċina (ADRs) fil-grupp mogħti Rydapt kienu newtropenja bid-deni (83.4%), dardir (83.4%), dermatite esfoljattiva (61.6%), rimettar (60.7%), uġigħ ta' ras (45.9%), petechiae (35.
English: The following medicines must be avoided during treatment with Rydapt: - medicines used to treat tuberculosis, such as rifampicin; - medicines used to treat epilepsy, such as carbamazepine or phenytoin; - enzalutamide, a medicine used to treat prostate cancer; - St. John's Wort (also known as Hypericum perforatum), a herbal medicine used to treat depression.
Maltese: Il-mediċini li ġejjin għandhom jiġu evitati waqt it-trattament b'Rydapt: - mediċini użati biex jittrattaw it-tuberkolożi, bħal rifampicin; - mediċini użati biex jittrattaw l-epilessija, bħal carbamazepine jew phenytoin; - enzalutamide, mediċina użata biex tittratta kanċer tal-prostata;
English: Common (may affect up to 1 in every 10 people) - upper respiratory tract infection - nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle weakness and twitching (signs of high levels of calcium in the blood, known as hypercalcaemia) - fainting - involuntary shaking of the body - headache, dizziness (high blood pressure) - fast heart beat (sinus tachycardia) - collection of fluid around the heart, which, if severe, can decrease the heart's ability to pump blood (pericardial effusion) - fluid collection in the lungs/chest cavity, which, if severe, could make you breathless (pleural effusion) - sore throat and a runny nose - swelling of the eyelid - discomfort in the anus and rectum - abdominal pain, nausea, vomiting, constipation (abdominal discomfort) - dry skin - eye pain, blurred vision, intolerance to light (keratitis) - neck pain - bone pain - pain in limbs - increased weight - blood clotted in the catheter - abnormal blood test results which can indicate to your doctor how well certain parts of your body are functioning: high levels of uric acid
Maltese: Komuni (jistgħu jaffettwaw sa persuna waħda minn kull 10) - infezzjoni fin-naħa ta' fuq tal-passaġġ respiratorju - dardir, rimettar, konsitpazzjoni, uġigħ fl-istonku, tagħmel l-awrina spiss, għatx, muskoli dgħajfa u bugħawwiġ (sinjali ta' livelli għolja ta' kalċju fid-demm, magħrufin bħala iperkalċemija) - mejt - tregħid involuntarju tal-ġisem - uġigħ ta' ras, sturdament (pressjoni għolja fid-demm) - taħbit tal-qalb mgħaġġel (takikardija tas-sinus) - fluwidu miġmugħ madwar il-qalb, li, jekk ikun sever, jista' jnaqqas il-ħila tal-qalb li tippompja d-demm (effużjoni perikardjali) - fluwidu miġmugħ fil-pulmun/qafas ta' sidrek, li, jekk ikun sever, jista' jħallik bla nifs (effużjoni plewrali) - griżmejn misluħin u flissjoni - kpiepel tal-għajnejn minfuħin - skumdità fl-anus u r-rektum - uġigħ fl-addome, dardir, rimettar, konstipazzjoni (skumdità addominali) - ġilda xotta - uġigħ fl-għajn, viżta mċajpra, intolleranza għad-dawl (keratite) - uġigħ fl-għonq - uġigħ fl-għadam - uġigħ fid-dirgħajn u r-riġlejn - żieda fil-piż - demm maqgħqud fil-catheter - riżultati tat-testijiet tad-demm mhux normali li jistgħu jindikaw lit-tabib tiegħek kemm ċerti partijiet ta' ġismek qed jaħdmu tajjeb: livelli għoljin ta' aċidu uriku
English: Patients should be monitored for pulmonary symptoms indicative of ILD or pneumonitis and Rydapt discontinued in patients who experience pulmonary symptoms indicative of ILD or pneumonitis that are ≥Grade 3 (NCI CTCAE).
Maltese: Il-pazjenti għandhom ikunu mmonitorati għal sintomi pulmonari indikattivi ta' ILD jew pnewmonite u Rydapt għandu jitwaqqaf għal kollox f'pazjenti li jġarrbu sintomi pulmonari indikattivi ta' ILD jew pnewmonite li huma fi ≥Grad 3 (NCI CTCAE).
English: Rydapt may reduce fertility in men and women.
Maltese: Rydapt jista' jnaqqas il-fertilità fl-irġiel u n-nisa.
English: Most of the side effects are mild to moderate and will generally disappear after a few weeks of treatment.
Maltese: Ħafna mill-effetti sekondarji huma bejn ħfief u moderati u normalment jitilqu wara ftit ġimgħat mittrattament.
English: CIR (CR induction) (HR) *Odds ratio calculated as (No complete remission in treatment/Complete remission in treatment) / (No complete remission in placebo/complete remission in placebo) HR= Hazard ratio; OR=odds ratio
Maltese: CIR (induzzjoni CR) (HR) *Il-probabbiltajiet ta' kisbiet inħadmu bħala (Ebda remissjoni sħiħa bit-trattament/Remissjoni sħiħa bit-trattament) / (Ebda remissjoni sħiħa bil-plaċebo/Remissjoni sħiħa bil-plaċebo) HR= Probabbiltà ta' riskju; OR=Probabbiltà ta' kisba