FrancophonIA/ELRC3.0 huggingface dataset:
English: a. infusion-related reaction (drug hypersensitivity, anaphylactic reaction, anaphylactoid reaction, hypersensitivity and cytokine release syndrome) b. hypothyroidism (myxoedema) c. adrenal insufficiency (Addison's disease, adrenocortical insufficiency acute, secondary adrenocortical insufficiency) d. hypophysitis (hypopituitarism) e. thyroiditis (autoimmune thyroiditis and thyroid disorder) f.
Maltese: It-termini li ġejjin jirrappreżentaw grupp ta' avvenimenti relatati li jiddeskrivu kondizzjoni medika aktar milli avveniment waħdu. a. reazzjoni marbuta mal-infużjoni (sensittività eċċessiva għall-mediċina, reazzjoni anafilattika, reazzjoni anafilaktojd,
English: Pembrolizumab doses of 2 mg/kg every 3 weeks, 10 mg/kg every 3 weeks, and 10 mg/kg every 2 weeks were evaluated in melanoma or previously treated NSCLC clinical trials.
Maltese: Dożi ta' pembrolizumab ta' 2 mg/kg kull 3 ġimgħat, 10 mg/kg kull 3 ġimgħat, u 10 mg/kg kull ġimagħtejn ġew evalwati fil-provi kliniċi ta' melanoma jew ta' NSCLC li kienet ġiet ittrattata qabel.
English: PD-L1 positive
Maltese: negattivi għal PD-L1
English: The median duration was 1.6 months (range 1 day to 27.3+ months).
Maltese: Il-medjan tat-tul ta' żmien kien ta' 1.6 xhur (firxa minn jum 1 sa 27.3+ xhur).
English: Pembrolizumab may be restarted within 12 weeks after last dose of KEYTRUDA if the adverse reaction remains at Grade ≤ 1 and corticosteroid dose has been reduced to ≤ 10 mg prednisone or equivalent per day.
Maltese: Pembrolizumab jista' jinbeda mill-ġdid fi żmien 12-il ġimgħa wara l-aħħar doża ta' KEYTRUDA jekk ir-reazzjoni avversa tibqa' ta' Grad ≤ 1 u d-doża tal-kortikosterojd tkun tnaqqset għal ≤ 10 mg ta' prednisone jew ekwivalenti kuljum.
English: Secondary efficacy outcome measures were duration of response, PFS, and OS. Table 21 summarises the key efficacy measures for the study population at the final analysis based on a median follow-up time of 11.4 months (range: 0.1, 41.2 months) for all patients.
Maltese: Tabella 21 tiġbor fil-qosor il-miżuri tal-effikaċja l-aktar importanti għall-popolazzjoni tal-istudju flanaliżi finali abbażi ta' żmien medjan ta' segwitu ta' 11.4 xhur (medda: 0.1, 41.2 xhur) għall-pazjenti kollha.
English: Uncommon hepatitis hepatitis
Maltese: Mhux komuni epatitep epatitep
English: Pneumonitis occurred more frequently in patients with a history of prior thoracic radiation (8.1%) than in patients who did not receive prior thoracic radiation (3.4%).
Maltese: Il-pulmonite seħħet aktar frekwenti f'pazjenti bi storja ta' radjazzjoni toraċika preċedenti (8.1%) milli f'pazjenti li ma rċivewx radjazzjoni toraċika preċedenti (3.4%).
English: OS and PFS benefits were observed regardless of PD-L1 expression level.
Maltese: Il-benefiċċji ta' OS u PFS ġew osservati irrispettivament mill-livell ta' espressjoni ta' PD-L1.
English: Figure 1: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-006 (intent to treat population)
Maltese: Kaplan-Meier għas-sopravivenza totali skont il-fergħa ta' trattament f' KEYNOTE-006 (popolazzjoni bl-intenzjoni li tiġi ttrattata)
English: * Hazard ratio (pembrolizumab compared to ipilimumab) based on the stratified Cox proportional hazard model
Maltese: * Proporzjon ta' periklu (pembrolizumab imqabbel mal-kimoterapija) ibbażat fuq il-mudell ta' periklu proporzjonali stratifikat ta' Cox †
English: The safety profile in these paediatric patients was generally similar to that seen in adults treated with pembrolizumab.
Maltese: Il-profil tas-sigurtà f'dawn il-pazjenti pedjatriċi b'mod ġenerali kien simili għal dak li deher f'adulti ttrattati b'pembrolizumab.
English: All prescribers of KEYTRUDA must be familiar with the Physician Information and Management Guidelines.
Maltese: Dan ser jippermetti identifikazzjoni ta' malajr ta' informazzjoni ġdida dwar is-sigurtà.
English: leukocytes); decrease in the number of platelets (bruising or bleeding more easily) - reaction related to the infusion of the medicine - inflammation of the pituitary gland situated at the base of the brain; inflammation of the thyroid; decreased secretion of hormones produced by the adrenal glands - decreased potassium, sodium or calcium in the blood - trouble sleeping - dizziness; lack of energy; inflammation of the nerves causing numbness, weakness, tingling or burning pain of the arms and legs - dry eye - abnormal heart rhythm - inflammation of the lungs - inflammation of the intestines; dry mouth - red raised rash, sometimes with blisters; acne-like skin problem; inflammation of the skin; dry,
Maltese: tnaqqis fis-sekrezzjoni tal-ormoni magħmula mill-glandoli adrenali - tnaqqis fil-potassium, fis-sodium jew fil-calcium fid-demm - diffikultà biex torqod - sturdament; nuqqas ta' enerġija; infjammazzjoni tan-nervituri li tikkawża titrix, dgħufija, tingiż jew uġigħ jaħraq fl-idejn u s-saqajn - għajn xotta - ritmu ta' taħbit tal-qalb mhux normali - infjammazzjoni tal-pulmun
English: The effect of renal impairment on the clearance of pembrolizumab was evaluated by population pharmacokinetic analyses in patients with mild or moderate renal impairment compared to patients with normal renal function.
Maltese: L-effett ta' indeboliment tal-kliewi fuq it-tneħħija ta' pembrolizumab ġie ivvalutat permezz ta' analiżi ta' farmakokinetika ta' popolazzjoni f'pazjenti b'indeboliment minn ħafif sa moderat tal-kliewi mqabbla ma' pazjenti b'funzjoni normali tal-kliewi.
English: Table 20: OS by PD-L1 Expression
Maltese: OS skont l-Espressjoni ta' PD-L1
English: The major efficacy outcome measures (ORR and CRR) were assessed by blinded independent central review according to the 2007 revised International Working Group (IWG) criteria.
Maltese: Il-miżuri maġġuri tar-riżultat tal-effikaċja (ORR u CRR) ġew stmati permezz ta' analiżi indipendenti ċentrali blinded skont il-kriterji riveduti tal-2007 tal-Grupp Internazzjonali ta' Ħidma (IWGInternational Working Group).
English: The safety of pembrolizumab was evaluated in a 1-month and a 6-month repeat-dose toxicity study in Cynomolgus monkeys administered intravenous doses of 6, 40 or 200 mg/kg once a week in the 1-month study and once every two weeks in the 6-month study, followed by a 4-month treatment-free period.
Maltese: Is-sigurtà ta' pembrolizumab ġiet ivvalutata fi studju ta' tossiċità minn dożi ripetuti ta' xahar u ta' 6 xhur f'xadini Cynomolgus li ngħataw dożi ta' 6, 40 jew 200 mg/kg mill-vini darba fil-ġimgħa flistudju ta' xahar u darba kull ġimagħtejn fl-istudju ta' 6 xhur, segwiti minn perjodu ta' 4 xhur mingħajr trattament.
English: Uncommon (may affect up to 1 in 100 people) - a decreased number of white blood cells (neutrophils, leukocytes, and eosinophils) - an immune disorder that can affect the lungs, skin, eyes and/or lymph nodes (sarcoidosis) - inflammation of the pituitary gland situated at the base of the brain; decreased secretion of hormones produced by the adrenal glands; inflammation of the thyroid - type 1 diabetes - seizure - inflammation of the eyes; eye pain, irritation, itchiness or redness; uncomfortable sensitivity to light; seeing spots - inflammation of the covering of the heart; accumulation of fluid around the heart - inflammation of the pancreas - inflammation of the liver - thickened, sometimes scaly, skin growth; inflammation of the skin; hair colour changes; small skin bumps, lumps or sores - inflammation of the sheath that surrounds tendons - inflammation of the kidneys - increased level of amylase, an enzyme that breaks down starch
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100) - tnaqqis fin-numru ta' ċelluli bojod tad-demm (limfoċiti u eosinofili) - dijabete tat-tip 1 - kundizzjoni li fiha l-muskolu jsir dgħajjef u jgħejja malajr - infjammazzjoni tal-muskolu tal-qalb, li tista' tidher bħala qtugħ ta' nifs, taħbit irregolari tal qalb, tħossok għajjien/a, jew uġigħ fis-sider - infjammazzjoni fl-għajnejn; uġigħ fl-għajn, irritazzjoni, ħakk jew ħmura; sensittività skomda għad-dawl; tara dbabar tondi - infjammazzjoni tal-frixa - bidliet fil-kulur tax-xagħar; tkabbir fil-ġilda li jeħxien u xi drabi jkun bil-qoxra; ħotob, boċċi jew selħiet żgħar fil-ġilda; rqajja' li jitilfu l-kulur fil-ġilda - żieda fil-livell ta' amylase, enzima li tiddiżintegra l-lamtu
English: Overall response rate ORR
Maltese: Differenza fl-ORR,
English: Following administration of pembrolizumab 200 mg every 3 weeks in patients with cHL, the observed median Cmin at steady-state was up to 40% higher than that in other tumour types treated with the same dosage; however, the range of trough concentrations is similar.
Maltese: Wara l-għoti ta' pembrolizumab 200 mg kull 3 ġimgħat f'pazjenti b'cHL, il-medjan tas-Cmin osservat fi stat fiss kien sa 40% ogħla minn dak f'tipi ta' tumuri oħra ttrattati bl-istess dożaġġ; madankollu ilfirxa tal-inqas konċentrazzjonijiet hija simili.
English: KEYNOTE-407: Controlled trial of combination therapy in squamous NSCLC patients naïve to treatment
Maltese: KEYNOTE-361 huwa prova klinika kkontrollata ta' Fażi
English: The primary efficacy outcomes were OS and PFS as assessed by BICR using RECIST v1.1.
Maltese: Ir-riżultati primarji tal-effikaċja kienu OS u PFS stmati permezz ta' BICR bl-użu ta' RECIST v1.1.
English: Prior to launch of KEYTRUDA in each Member State the MAH must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: Qabel l-introduzzjoni ta' KEYTRUDA fis-suq f'kull Stat Membru l-MAH għandu jaqbel malAwtorità Nazzjonali Kompetenti fuq il-kontenut u l-preżentazzjoni tal-programm ta' edukazzjoni, inkluż il-mezzi ta' komunikazzjoni, il-modi ta' distribuzzjoni u kwalunkwe aspett ieħor tal-programm.
English: However, systemic corticosteroids or other immunosuppressants can be used after starting pembrolizumab to treat immune-related adverse reactions (see section 4.4).
Maltese: Madankollu, wara li wieħed jibda pembrolizumab kortikosterojdi sistemiċi jew immunosoppressanti oħra jistgħu jintużaw biex jiġu ttrattati reazzjonijiet avversi marbuta malimmunità (ara sezzjoni 4.4).
English: 1Q 2021
Maltese: It-tielet kwart tal-2021
English: Table 7: Efficacy results by BRAF mutation status in KEYNOTE-006
Maltese: Riżultati ta' effikaċja skont l-istat ta' mutazzjoni BRAF f' KEYNOTE-006
English: Based on the modelling and simulation of dose/exposure relationships for efficacy and safety for pembrolizumab, there are no clinically significant differences in efficacy or safety among the doses of 200 mg every 3 weeks, 2 mg/kg every 3 weeks, and 400 mg every 6 weeks as monotherapy (see section 4.2).
Maltese: Abbażi ta' mudellar u simulazzjoni tar-relazzjonijiet bejn id-doża/l-esponiment għall-effikaċja u ssigurtà ta' pembrolizumab, ma kien hemm l-ebda differenzi sinifikanti b'mod kliniku fl-effikaċja jew fis-sigurtà fost id-dożi ta' 200 mg kull 3 ġimgħat, 2 mg/kg kull 3 ġimgħat, u 400 mg kull 6 ġimgħat bħala monoterapija (ara sezzjoni 4.2).
English: Eighty-seven percent of patients had visceral metastases, including 34% with liver metastases.
Maltese: Sebgħa u tmenin fil-mija tal-pazjenti kellhom metastasi fil-vixxri, inkluż 34% li kellhom metastasi filfwied.
English: The primary efficacy outcome was OS in the ITT population.
Maltese: Mhux komuni nefritez Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata
English: A total of 67 patients in the placebo plus chemotherapy arm crossed over to receive monotherapy pembrolizumab at the time of disease progression and 18 additional patients received a checkpoint inhibitor as subsequent therapy.
Maltese: Total ta' 67 pazjent filfergħa tal-plaċebo flimkien mal-kimoterpija qalbu biex bdew jirċievu monoterapija b'pembrolizumab fiż-żmien tal-progressjoni tal-marda u 18-il pazjenti addizzjonali rċivew inibitur checkpoint bħala terapija sussegwenti.
English: The following factors had no clinically important effect on the clearance of pembrolizumab: age (range 15-94 years), gender, race, mild or moderate renal impairment, mild hepatic impairment and tumour burden.
Maltese: Il-fatturi li ġejjin ma kellhom l-ebda effett importanti b'mod kliniku fuq it-tneħħija ta' pembrolizumab: età (firxa minn 15-94 sena), sess, razza, indeboliment ħafif jew moderat tal-kliewi, indeboliment ħafif tal-fwied u l-kwantità ta' tumur fil-ġisem.
English: myasthenic syndrome h,
Maltese: Żmien f'Xhur
English: Complications, including graft-versus-host-disease (GVHD), in people with bone marrow (stem cell) transplant that uses donor stem cells (allogeneic).
Maltese: Komplikazzjonijiet ta' Trapjant Ematopoetiku ta' Ċelluli Stem (HSCT - Haematopoietic Stem Cell Transplant) alloġenejku
English: Treatment with pembrolizumab may increase the risk of rejection in solid organ transplant recipients.
Maltese: It-trattament b'pembrolizumab jista' jżid ir-riskju ta' rifjut f'persuni li jkunu rċevew trapjant ta' organu solidu.
English: Elevated liver enzymes when pembrolizumab is combined with axitinib in RCC In a clinical study of previously untreated patients with RCC receiving pembrolizumab in combination with axitinib, a higher than expected incidence of Grades 3 and 4 ALT increased (20%) and AST increased (13%) were observed.
Maltese: Fi studju kliniku ta' pazjenti b'RCC li ma kinux ġew ittrattati qabel li kienu qed jirċievu pembrolizumab flimkien ma' axitinib, ġiet osservata inċidenzi ogħla minn dik mistennija ta' żidiet flALT (20%) u fl-AST (13%) ta' Gradi 3 u 4.
English: This 96 hour total hold from reconstitution may include up to 6 hours at room temperature (at or below 25°C).
Maltese: Din iż-żamma totali ta' 96 siegħa mir-rikostituzzjoni tista' tinkludi sa 6 sigħat f'temperatura tal-kamra (ta' 25°C jew anqas).
English: Median follow-up time of 10.1 months Median follow-up time of 52.8 months Assessed by blinded independent central review according to the 2007 revised International Working Group (IWG) criteria by PET CT scans Based on patients (n=145) with a response by independent review Based on patients (n=18) with a response by independent review Based on Kaplan-Meier estimation; includes 31 patients with responses of 6 months or longer Based on Kaplan-Meier estimation; includes 9 patients with responses of 6 months or longer Based on Kaplan-Meier estimation; includes 7 patients with responses of 12 months or longer
Maltese: Internazzjonali ta' Ħidma (IWG) permezz ta' skans CT PET d Abbażi ta' pazjenti (n=145) b'rispons permezz ta' analiżi indipendenti e Abbażi ta' pazjenti (n=18) b'rispons permezz ta' analiżi indipendenti f Abbażi tal-istima Kaplan-Meier; tinkludi 31 pazjent b'ripsonsi ta' 6 xhur jew aktar g Abbażi tal-istima Kaplan-Meier; tinkludi 9 pazjenti b'riponsi ta' 6 xhur jew aktar h Abbażi tal-istima Kaplan-Meier; tinkludi 7 pazjenti b'riponsi ta' 12-il xahar jew aktar
English: Before you get KEYTRUDA, tell your doctor if you: - have an autoimmune disease (a condition where the body attacks its own cells) - have pneumonia or inflammation of your lungs (called pneumonitis) - were previously given ipilimumab, another medicine for treating melanoma, and experienced serious side effects because of that medicine - had an allergic reaction to other monoclonal antibody therapies - have or have had chronic viral infection of the liver, including hepatitis B (HBV) or hepatitis C (HCV) - have human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS) - have liver damage - have kidney damage - have had a solid organ transplant or a bone marrow (stem cell) transplant that used donor stem cells (allogeneic)
Maltese: Qabel jingħatalek KEYTRUDA, għid lit-tabib tiegħek jekk inti: - għandek marda awtoimmuni (kundizzjoni fejn il-ġisem jattakka ċ-ċelluli tiegħu stess) - għandek pnewmonja jew infjammazzjoni tal-pulmuni (msejħa pulmonite) - ngħatajt ipilimumab qabel, mediċina oħra biex titratta l-melanoma, u kellek effetti sekondarji serji minħabba dik il-mediċina - kellek reazzjoni allerġika għal terapiji b'antikorpi monoklonali oħra - għandek jew kellek infezzjoni kronika tal-fwied b'virus, inkluż epatite B (HBV - hepatitis B
English: Hepatitis has been reported in patients receiving pembrolizumab (see section 4.8).
Maltese: Ġiet irrappurtata epatite f'pazjenti li kienu qed jirċievu pembrolizumab (ara sezzjoni 4.8).
English: Patients receiving placebo plus chemotherapy who experienced independently-verified progression of disease were offered pembrolizumab as monotherapy.
Maltese: Il-pazjenti li kienu qed jirċievu plaċebo flimkien ma' kimoterapija li kellhom progressjoni tal-marda vverifikata b'mod indipendenti ġew offruti pembrolizumab bħala monoterpija.
English: itchy skin; hair loss - inflammation of the liver - muscle pain, aches or tenderness; joint or muscle pain with swelling; inflammation of the sheath that surrounds tendons - sudden kidney damage; inflammation of the kidneys - swelling; flu-like illness; chills - increased calcium in the blood; increased liver enzyme levels in the blood
Maltese: tieklok; jaqa' x-xagħar; problema fil-ġilda tixbah lill-akne - uġigħ, weġgħat jew sensittività fil-muskoli; uġigħ fid-dirgħajn jew fir-riġlejn; uġigħ fil-ġogi flimkien ma' nefħa - tkexkix ta' bard; mard jixbaħ lill-influwenza - żieda fil-livelli ta' enzimi tal-fwied fid-demm; żieda fil-kalċju fid-demm; riżultat mhux normali għal test tal-funzjoni tal-kliewi
English: Adrenal insufficiency led to discontinuation of pembrolizumab in 4 (0.1%) patients.
Maltese: Insuffiċjenza tal-glandoli adrenali wasslet għat-twaqqif ta' pembrolizumab f'4 (< 0.1%) pazjenti.
English: Figure 4: Kaplan-Meier curve for recurrence-free survival by treatment arm in KEYNOTE-054 (intent to treat population)
Maltese: Kaplan-Meier għas-sopravivenza mingħajr rikorrenza skont il-fergħa tattrattament f'KEYNOTE-054 (popolazzjoni bl-intenzjoni li tiġi ttratata)
English: Post-authorisation efficacy study (PAES): The MAH should submit the final study report for study P426: A Phase III Randomised, Open-label Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in combination with Axitinib versus Sunitinib Monotherapy as a First-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC)
Maltese: III biex Jevalwa l-Effikaċja u s-Sigurta ta' Pembrolizumab (MK-3475) flimkien ma' Axitinib versus Monoterapija b'Sunitinib bħala tTrattament tal-Ewwel Għażla għal Karċinoma taċ-Ċelluli Renali Avanzata b'Mod Lokali jew Metastatika (mRCC - Metastatic Renal Cell Carcinoma)
English: type 1 diabetes mellitus (diabetic ketoacidosis) g. Guillain-Barré syndrome (axonal neuropathy and demyelinating polyneuropathy) h. myasthenic syndrome (myasthenia gravis, including exacerbation) i.
Maltese: Il-pazjenti ntagħżlu b'mod arbitrarju (2:1) biex jirċievu waħda mill-iskedi li ġejjin:
English: Table 24: Efficacy results for pembrolizumab as monotherapy in KEYNOTE-048 with PD-L1 expression (CPS ≥ 1)
Maltese: Riżultati tal-effikaċja għal pembrolizumab bħala monoterapija f'KEYNOTE-048 b'espressjoni ta' PD-L1 (CPS ≥ 1)
English: Pneumonitis has been reported in patients receiving pembrolizumab (see section 4.8).
Maltese: Ġiet irrappurtata pulmonite f'pazjenti li kienu qed jirċievu pembrolizumab (ara sezzjoni 4.8).
English: Post-authorisation efficacy study (PAES): The MAH should submit the final study report for study P407: A Randomised, Double-Blind, Phase III Study of Carboplatin - Paclitaxel/Nab-Paclitaxel Chemotherapy with or without Pembrolizumab (MK-3475) in First Line Metastatic Squamous Non-small Cell Lung Cancer Subjects - Final Study Report
Maltese: III ta' Kimoterapija b'Carboplatin - Paclitaxel/NabPaclitaxel flimkien ma' Pembrolizumab (MK-3475) jew mingħajru bħala tTerapija Ppreferuta f'Individwi b'Kanċer tal-Pulmun Skwamuż Metastatiku Mhux taċ-Ċelluli ż-żgħar - Rapport Finali tal-Istudju
English: Corticosteroids should be administered for Grade ≥ 2 events (initial dose of 1-2 mg/kg/day prednisone or equivalent followed by a taper) and, based on severity of creatinine elevations, pembrolizumab should be withheld for Grade 2, and permanently discontinued for Grade 3 or Grade 4 nephritis (see section 4.2).
Maltese: Il-kortikosterojdi għandhom jingħataw għal każijiet ta' Grad ≥ 2 jew aktar (doża tal-bidu ta' 1-2 mg/kg/jum prednisone jew ekwivalenti segwit bi tnaqqis bil-ftit il-ftit għal xejn), u, abbażi tas-severità ta' kemm huma għoljin il-livelli tal-kreatinina, pembrolizumab m'għandux jingħata f'nefrite ta' Grad 2, u għandu jitwaqqaf għalkollox f'nefrite ta' Grad 3 jew Grad 4 (ara sezzjoni 4.2).
English: Figure 12: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-045 (intent to treat population)
Maltese: Kaplan-Meier għal sopravivenza globali skont il-fergħa ta' trattament f'KEYNOTE-045 (popolazzjoni bl-intenzjoni li tiġi ttrattata)
English: Pembrolizumab 2 mg/kg every 3 weeks
Maltese: Pembrolizumab 2 mg/kg kull 3 ġimgħat
English: Each carton contains one vial.
Maltese: - Treddax waqt li tkun qed tieħu KEYTRUDA.
English: Grade 1 - 2
Maltese: Grad 1-2
English: ≥ 20,000/µL, haemoglobin > 8.0 g/dL
Maltese: 000/µL, emoglobina > 8.0 g/dL
English: • adequate liver function: alanine aminotransferase (ALT)/ aspartate aminotransferase (AST)
Maltese: • funzjoni adegwata tal-fwied: alanina aminotransferażi (ALT)/ aspartataminotransferażi (AST)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1191/001
Maltese: EU/1/17/1191/001
English: Date of first authorisation: 08 May 2017
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 8 ta' Mejju 2017
English: < 5 times upper limit of normal (ULN)
Maltese: < 5 darbiet il-limitu ta᾽ fuq tan-normal (ULN)
English: INFORMATION IN BRAILLE Qarziba
Maltese: INFORMAZZJONI BIL-BRAILLE Qarziba
English: • respiratory failure, fluid in the lungs
Maltese: • insuffiċjenza respiratorja, fluwidu fil-pulmun
English: • The active substance is dinutuximab beta.
Maltese: • Is-sustanza attiva hija dinutuximab beta.
English: • itching, rash
Maltese: • ħakk, raxx
English: Intravenous immunoglobulin
Maltese: Immunoglobulina ġol-vina
English: System organ class Very common
Maltese: Sistema talklassifika tal-organi
English: Study 1 N=15
Maltese: Studju 1 N=15
English: Recommended dose modifications for dinutuximab beta Adverse reaction Severity
Maltese: Modifiki fid-doża rakkomandati għal dinutuximab beta Reazzjoni avversa Severità
English: per course.
Maltese: JIS.
English: with IL-2 N=107
Maltese: b᾽IL-2 N=107
English: Musculoskeletal and connective tissue disorders muscle spasms
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi spażmi fil-muskoli
English: Dose modification of dinutuximab beta
Maltese: Modifikazzjoni fid-doża ta᾽ dinutuximab beta
English: Serious anaphylactic reactions occurred in 3.5% of the patients.
Maltese: Seħħew reazzjonijiet anafilattiċi serji fi 3.5 % tal-pazjenti.
English: Capillary leak syndrome (CLS)
Maltese: Sindrome ta᾽ tnixxija kapillari (CLS)
English: • Risk management plan (RMP)
Maltese: • Pjan tal-gestjoni tar-riskju (RMP)
English: Safety profile with and without IL-2
Maltese: Profil tas-sigurtà bi jew mingħajr IL-2
English: The daily dose is 10 mg/m2.
Maltese: Id-doża ta᾽ kuljum hija 10 mg/m2.
English: Study 1 N=29
Maltese: Studju 1 N=29
English: The combination of Qarziba with IL-2 increases the risk of adverse drug reactions compared to Qarziba without IL-2, especially for pyrexia (92% vs. 79%), CLS (50% vs. 25%), pain related to dinutuximab beta (75% vs. 63%), hypotension (43% vs. 26%), and peripheral neuropathy (14% vs. 7%), respectively.
Maltese: Il-kombinazzjoni ta᾽ Qarziba ma᾽ IL-2 żżid ir-riskju ta᾽ reazzjonijiet avversi tal-mediċini meta mqabbla ma᾽ Qarziba mingħajr IL-2, speċjalment għal deni (92 % vs 79 %), CLS (50 % vs 25 %), uġigħ relatat ma᾽ dinutuximab beta (75 % vs 63 %), pressjoni baxxa (43 % vs 26 %), u newropatija periferali (14 % vs 7 %), rispettivament.
English: with IL-2 N=76
Maltese: b᾽IL-2 N=76
English: • pulse oximetry > 94% on room air
Maltese: • ossimetrija tal-polz > 94 % fuq arja tal-kamra
English: Study 2 N=19
Maltese: Studju 2 N=19