FrancophonIA/ELRC3.0 huggingface dataset:
English: Antihistamine premedication (e.g. hydroxyzine or diphenhydramine) should be administered by intravenous injection approximately 20 minutes before starting each dinutuximab infusion.
Maltese: Premedikazzjoni b'antihistamine (eż. hydroxyzine jew diphenhydramine) għandha tingħata permezz ta' injezzjoni ġol-vini madwar 20 minuta qabel tibda kull infużjoni b'dinutuximab.
English: Table 5 summarizes adverse drug reactions reported when dinutuximab was administered in combination with GM-CSF, IL-2, and isotretinoin.
Maltese: Tabella 5 tiġbor fil-qosor ir-reazzjonijiet avversi tal-mediċina rrappurtati meta dinutuximab ingħata flimkien ma' GM-CSF, IL-2, u isotretinoin.
English: Leukopaenia
Maltese: Lewkopenija
English: In this study, 27 children with high-risk neuroblastoma (age: 3.9 ± 1.9 years) received up to 5 cycles of Unituxin at 17.5 mg/m2/day as an intravenous infusion over 10 to 20 hours for 4 consecutive days every 28 days.
Maltese: F'dan l-istudju, 27 tifel/tifla b'newroblastoma ta' riskju għoli (età: 3.9 ± 1.9 snin) irċivew sa 5 ċikli ta' Unituxin b'rata ta' 17.5 mg/m2/jum bħala infużjoni ġol-vini fuq perjodu ta' minn 10 sa
English: • If abnormalities remain stable or improve before the next course administer dinutuximab at 0.875 mg/m2/h and full dose GM-CSF or IL-2.
Maltese: • Jekk l-anormalitajiet jibqgħu stabbli jew imorru għall-aħjar qabel il-kors li jkun imiss, agħti dinutuximab f'rata ta' 0.875 mg/m2/siegħa u doża sħiħa ta' GM-CSF jew IL-2.
English: • Start GM-CSF or IL-2 at 50 % of the dose when administered with dinutuximab.
Maltese: • Kompli GM-CSF jew IL-2 il-jum wara b'rata ta' 50% tad-doża sal-aħħar doża ta' dinutuximab għal dak il-kors.
English: Pyrexia, pain1, face oedema
Maltese: - stitikezza, demm fl-ippurgar
English: If tolerated, increase GM-CSF or
Maltese: Awmentazzjoni ta' ADCC fil-preżenza ta' GM-CSF u
English: The primary intent-to-treat (ITT) analysis found an improvement in EFS associated with dinutuximab immunotherapy plus isotretinoin, as compared to isotretinoin alone.
Maltese: L-analiżi tal-intenzjoni li tikkura (ITT) primarja sabet titjib f'EFS assoċjat mal-immunoterapija b'dinutuximab flimkien ma' isotretinoin, meta mqabbla ma' isotretinoin waħdu.
English: - atypical haemolytic uraemic syndrome (aHUS) - an illness that affects the blood system and kidney symptoms may include flu-like symptoms that do not go away, confusion, lethargy, loss of appetite, or dark coloured urine.
Maltese: - sindrome uremiku emolitiku atipiku (aHUS) - marda li taffettwa s-sistema tad-demm u l-kliewi - is sintomi jistgħu jinkludu sintomi li jixbhu l-influwenza li ma jfiqux, konfużjoni, letarġija, telf ta' aptit,
English: Serious infusion reactions requiring urgent intervention including blood pressure support, bronchodilator therapy, corticosteroids, infusion rate reduction, infusion interruption, or permanent discontinuation of Unituxin included facial and upper airway oedema, dyspnoea, bronchospasm, stridor, urticaria, and hypotension.
Maltese: Reazzjonijiet allerġiċi Reazzjonijiet serji tal-infużjoni jeħtieġu intervent urġenti li jinkludi appoġġ tal-pressjoni tad-demm, terapija bil-bronkodilatur, kortikosterojdi, tnaqqis fir-rata tal-infużjoni, interruzzjoni tal-infużjoni, jew it-twaqqif permanenti ta' Unituxin li jinkludi edema tal-wiċċ u n-naħa ta' fuq tal-passaġġ respiratorju, dispnea,
English: Granulocyte macrophage colony-stimulating factor (GM-CSF): 250 μg/m2/day, administered by either subcutaneous injection (strongly recommended) or intravenous infusion over 2 hours.
Maltese: Fattur li jistimula kolonji tal-makrofagi tal-granuloċiti (GM-CSF): 250 μg/m2/jum, mogħtija jew permezz ta'
English: This means it is essentially ‘sodium free'.
Maltese: Dan ifisser li hi essenzjalment ‘ħielsa mis-sodium'.
English: • If tolerated without worsening symptoms, administer dinutuximab at 1.75 mg/m2/h for subsequent courses.
Maltese: • Jekk ikun ittollerat mingħajr ma s-sintomi jmorru għall-agħar, agħti dinutuximab f'rata ta' 1.75 mg/m2/siegħa għal korsijiet sussegwenti.
English: The treatment regimen consists of dinutuximab, GM-CSF, IL-2, and isotretinoin, administered over six consecutive courses.
Maltese: Is-sintomi jerġgħu jseħħu • Waqqaf dinutuximab, GM-CSF u IL-2 għall-bqija tal-korsijiet.
English: Grade 4(life-threatening) Onset of symptoms
Maltese: Grad 4 (ta' theddida għall-ħajja)
English: No clinical signs of CNS toxicity were observed.
Maltese: Ma ġew osservati l-ebda sinjali kliniċi ta' tossiċità fis-CNS.
English: Unituxin is used with three other medicines: - Isotretinoin - GM-CSF - IL-2
Maltese: Unituxin jintuża ma' tliet mediċini oħrajn imsejħa:
English: Other medicines and Unituxin
Maltese: Mediċini oħra u Unituxin
English: • Permanently discontinue dinutuximab and GM-CSF or IL-2.
Maltese: • Waqqaf dinutuximab u GM-CSF jew IL-2 b'mod permanenti.
English: If morphine is not tolerated, then fentanyl or hydromorphone may be utilised.
Maltese: Jekk il-morfina ma tkunx ittollerata, allura fentanyl jew hydromorphone jistgħu jintużaw.
English: GM-CSF for remainder of IL-2 courses.
Maltese: GM-CSF jew IL-2
English: Supplemental oxygen, respiratory support, and albumin replacement therapy should be used as necessary according to clinical response.
Maltese: Ossiġnu supplimentari, appoġġ respiratorju, u terapija ta' sostituzzjoni tal-albumina għandhom jintużaw kif meħtieġ skont ir-rispons kliniku.
English: • If capillary leak syndrome occurred during GM-CSF course, administer dinutuximab alone for subsequent GM-CSF courses.
Maltese: • Jekk is-sindrome ta' tnixxija kapillari ikun seħħ matul kors b'GM-CSF, agħti dinutuximab waħdu għal korsijiet sussegwenti b'GM-CSF.
English: • If GM-CSF is not tolerated at 50 % of the dose, administer dinutuximab alone for the remainder of the GM-CSF courses.
Maltese: • Jekk GM-CSF ma jiġix ittollerat fir-rata ta' 50% tad-doża, agħti dinutuximab waħdu għall-bqija tal-korsijiet b'GM-CSF.
English: Prior to starting each treatment course, refer to Table 3 for a list of criteria that must be evaluated.
Maltese: Qabel ma tibda kull kors ta' kura, irreferi għal Tabella 3 għal lista ta' kriterji li jridu jiġu evalwati.
English: • Delay course initiation until dyspnoea at rest has been resolved and/or peripheral oxygen saturation is at least 94 % on room air. Renal dysfunction
Maltese: • Dewwem il-bidu tal-kors sakemm dispnea waqt li l-persuna tkun mistrieħa tkun fieqet, u/jew issaturazzjoni tal-ossiġnu periferali tkun ta' mill-inqas 94% fl-arja tal-kamra.
English: Uncommon side effects (may affect up to 1 in 100 people ): - unequal pupils - fluid in or around the lungs - kidney failure - over-active thyroid - serum sickness - an illness similar to an allergy - abnormal heart rhythm - swelling in the back part of the brain (Posterior Reversible Encephalopathy Syndrome) - symptoms may include high blood pressure, headache, fits, change in vision or behaviour, feeling drowsy or tired.
Maltese: riskju għoli (li tinkludi s-sistema nervuża ċentrali u periferali, il-prevalenza ta' disfunzjoni tal-organi, l-effetti fit-tul fuq it-tkabbir u l-iżvilupp endokrinali, telf tas-smigħ, tossiċità kardijaka u dejta dwar is-sopravivenza), l-applikant għandu jwettaq u jissottometti r riżultati ta' reġistru dwar is-sigurtà.
English: • Discontinue dinutuximab and intravenous GM-CSF or IL-2.
Maltese: • Jekk is-sintomi jerġgħu jseħħu, waqqaf dinutuximab, GM-CSF u IL-2
English: Capillary leak syndrome is more likely when dinutuximab is co-administered with IL-2.
Maltese: Effetti sekondarji oħra li jista' jkollok b'din il-mediċina jinkludu:
English: Adverse reactions reported for subjects receiving dinutuximab in combination with GM-CSF, IL-2, and isotretinoin are summarised in Table 5.
Maltese: Reazzjonijiet avversi rrappurtati għal individwi li jirċievu dinutuximab flimkien ma' GM-CSF, IL-2, u isotretinoin qed jintwerew fil-qosor f'Tabella 5.
English: In a population pharmacokinetic analysis, the geometric mean volume of distribution at steady state was estimated at 5.2 L.
Maltese: F'analiżi farmakokinetika talpopolazzjoni, il-volum medju ġeometriku tad-distribuzzjoni fl-istat kien stmat li hu 5.2 L.
English: • Resume dinutuximab at 0.875 mg/m2/h once BP is stable.
Maltese: • Erġa' ibda dinutuximab b'rata ta' 0.875 mg/m2/siegħa ġaladarba l-BP
English: Table 4: Dose modification guidance for the management of treatment-emergent adverse reactions during administration of dinutuximab in combination with GM-CSF, IL-2 and isotretinoin.
Maltese: Tabella 4: Gwida għal modifikazzjoni tad-doża għall-immaniġġjar ta' reazzjonijiet avversi li jiżviluppaw mill-kura waqt l-għoti ta' dinutuximab flimkien ma' GM-CSF, IL-2 u isotretinoin.
English: Subgroup analyses of EFS and OS response indicated that patients with minimal residual disease, DNA hyperploidy, and those having received a purged bone marrow may not have benefited from dinutuximab immunotherapy.
Maltese: Analiżijiet ta' sottogruppi ta' rispons EFS u OS indikaw li pazjenti b'mard residwu minimu, DNA
English: Eye disorders may occur, especially with repeated courses (see section 4.8).
Maltese: Jistgħu jseħħu disturbi tal-għajnejn, speċjalment b'korsijiet ripetuti (ara sezzjoni 4.8).
English: How to store Unituxin
Maltese: Kif jaħdem Unituxin
English: • You will be given isotretinoin to take by mouth for the last 14 days of each course.
Maltese: • Inti se tingħata isotretinoin biex tieħdu mill-ħalq għall-aħħar 14-il jum ta' kull kors.
English: What Unituxin is
Maltese: X'inhu Unituxin
English: Table 5: Adverse reactions that have occurred during studies in high risk neuroblastoma patients receiving dinutuximab in combination with GM-CSF, IL-2, and isotretinoin.
Maltese: Tabella 5: Reazzjonijiet avversi li seħħew matul l-istudji f'pazjenti f'riskju għoli ta' newroblastoma li kienu qed jirċievu dinutuximab flimkien ma' GM-CSF, IL-2, u isotretinoin.
English: Electrolyte abnormalities have been reported in patients who received Unituxin.
Maltese: Anormalitajiet fl-elettroliti ġew irrappurtati f'pazjenti li rċivew Unituxin.
English: High-risk neuroblastoma was based on the patient age (greater than 12 months) and tumour stage at diagnosis and / or the presence of biological risk factors, such as MYCN amplification.
Maltese: Newroblastoma ta' riskju għoli kienet ibbażata fuq l-età talpazjent (iktar minn 12-il xahar) u l-istadju tat-tumur meta saret id-dijanjosi u/jew il-preżenza ta' fatturi ta' riskju bijoloġiċi, bħal amplifikazzjoni ta' MYCN.
English: Patients typically have a central venous catheter in situ and as a consequence of prior ASCT are likely to be immunocompromised during therapy, and therefore, at risk of developing systemic infection.
Maltese: Il-pazjenti tipikament ikollhom kateter venuż ċentrali in situ u bħala konsegwenza ta' ASCT fil-passat, x'aktarx li se jkunu immunokompromessi matul it-terapija, u għalhekk, f'riskju li jiżviluppaw infezzjoni sistematika.
English: Constipation, lower gastrointestinal haemorrhage
Maltese: enċefaloptija riversibbli posterjuri
English: In addition, it has been shown to induce both antibody dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity in vitro.
Maltese: Barra minn hekk, intwera li jinduċi kemm ċitotossiċità medjata miċ-ċellula dipendenti fuq l-antikorpi (ADCC) u ċitotossiċità dipendenti fuq il-komplement in vitro.
English: increase the dinutuximab infusion to 1.75 mg/m2/h.
Maltese: Id-doża rakkomandata hija ta' 17.5 mg/m2.
English: These adverse reactions are presented by MedDRA system organ class and frequency.
Maltese: Dawn ir-reazzjonijiet huma ppreżentati skont is-sistema tal klassifika tal-organi MedDRA u l-frekwenza.
English: Hypokalaemia, hyponatraemia, hypocalcaemia, hypophosphataemia, hypoalbuminaemia, hyperglycaemia, decreased appetite
Maltese: Żieda f'gamma glutamyltransferase, żieda fil-kreatinina fid demm, żieda fil-piż
English: • Resume GM-CSF or IL-2 the following day at 50 % of the dose if BP
Maltese: • Ibda GM-CSF jew IL-2 b'rata ta' 50% tad-doża, żid għad-doża sħiħa jekk
English: Like all medicines, this medicine, which is given with GM-CSF, IL-2 and isotretinoin can cause side effects, although not everybody gets them.
Maltese: Riskju għal interazzjonijiet ma' prodotti mediċinali użati fl-istess ħin ma jistax jiġi eskluż.
English: Supportive measures should be instituted including control of hydration status, electrolyte abnormalities, hypertension, and anaemia.
Maltese: Miżuri ta' appoġġ għandhom jinbdew, li jinkludu l-kontroll tal-istat ta' idratazzjoni, anormalitajiet fl-elettroliti, pressjoni għolja, u anemija.
English: Allergic reactions
Maltese: sensittività eċċessiva
English: Central nervous system (CNS) toxicity
Maltese: Il-konċentrazzjoni massima medja (± devjazzjoni standard)
English: Unituxin should be discontinued if pain is not adequately controlled despite infusion rate reduction and institution of maximum supportive measures (see sections 4.2 and 4.8).
Maltese: Unituxin għandu jitwaqqaf jekk l-uġigħ ma jiġix ikkontrollat b'mod adegwat minkejja t-tnaqqis fir-rata tal-infużjoni u l-bidu ta' miżuri massimi ta' appoġġ (ara sezzjonijiet 4.2 u 4.8).
English: • Resume infusion at the original rate.
Maltese: • Kompli l-infużjoni bir-rata oriġinali.
English: Dinutuximab was administered at a dose equivalent to 17.5 mg/m2/day on four consecutive days (Days 4-7) of Courses 1-5.
Maltese: Dinutuximab ingħata f'doża ekwivalenti għal 17.5 mg/m2/jum fuq perjodu ta' erbat ijiem konsekuttivi (Jiem
English: For instructions on dilution of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq id-dilwizzjoni tal-prodott mediċinali qabel l-amministrazzjoni, ara sezzjoni 6.6
English: For severe pain, the Unituxin infusion rate should be decreased to 0.875 mg/m2/hour.
Maltese: Għal uġigħ sever, ir-rata tal-infużjoni ta' Unituxin għandha titnaqqas għal 0.875 mg/m2/siegħa.
English: - higher risk of getting infections especially from the devices used to give you the medicine, blood or gut infections - skin problems where the injection was given, a red rash with small bumps - abnormal blood tests such as low levels of magnesium, glucose, high level of acids or creatinine.
Maltese: - problemi tal-ġilda fejn tkun ingħatat l-injezzjoni, raxx aħmar b'ħafas żgħar - testijiet tad-demm b'riżultat mhux normali bħal livelli baxxi ta' magnesium, glucose, livell għoli ta' aċidi jew kreatinina
English: Dinutuximab has been shown to bind to neuroblastoma cell lines known to express GD2 in vitro.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall
English: Classical biotransformation studies have not been performed.
Maltese: Ma twettqux studji klassiċi dwar il-bijotrasformazzjoni.
English: • Delay course initiation until CNS toxicity is Grade 1 or resolved and/or seizure disorder is well controlled Hepatic dysfunction
Maltese: • Dewwem il-bidu tal-kors sakemm it-tossiċità tas-CNS tkun ta' Grad 1 jew tgħaddi u/jew id-disturb tal-aċċessjonijiet ikun ikkontrollat tajjeb
English: 28108 Madrid SPAIN
Maltese: 28108 Madrid SPANJA
English: • Physical function (HAQ-DI)
Maltese: • Funzjoni fiżika (HAQ-DI)
English: C-reactive protein
Maltese: Proteina reattiva C
English: • Radiographic progression (mTSS)
Maltese: • Progressjoni radjugrafika (mTSS)
English: Haemoglobin (Hb)
Maltese: Emoglobina (Hb)
English: • iron oxide red (E172)
Maltese: • iron oxide aħmar (E172)
English: Pharmacotherapeutic group: Selective immunosuppressants, ATC code: L04AA37
Maltese: Immunosoppressanti selettivi, Kodiċi ATC: L04AA37
English: RA-BUILD cDMARD-IR patients
Maltese: RA-BUILD pazjenti cDMARD-IR
English: Olumiant 2 mg film-coated tablets EU/1/16/1170/001
Maltese: Olumiant 2 mg pilloli miksijin b'rita EU/1/16/1170/001
English: * p ≤ 0.05; ** p ≤ 0.01; *** p ≤ 0.001 vs. placebo (vs. MTX for study RA-BEGIN)
Maltese: * p ≤ 0.05; ** p ≤ 0.01; *** p ≤ 0.001 vs. plaċebo (vs. MTX għall-istudju RA-BEGIN)
English: RA-BEACON TNF-IR patients
Maltese: RA-BEACON pazjenti TNF-IR
English: Immunoglobulins
Maltese: Immunoglobulini
English: - The other ingredients are: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, mannitol, iron oxide red (E172), lecithin (soya) (E322), macrogol, poly (vinyl alcohol), talc and titanium dioxide (E171).
Maltese: - Is-sustanzi l-oħra huma: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, mannitol, iron oxide aħmar (E172), lecithin (soja) (E322), macrogol, poly (vinyl alcohol), talc u titanium dioxide (E171).
English: Immunomodulatory medicinal products may increase the risk of malignancies including lymphoma.
Maltese: Prodotti mediċinali immunomodulatorji jistgħu jżidu r-riskju ta' tumuri malinni inkluż limfoma.
English: Transporters
Maltese: Trasportaturi
English: In isolated enzyme assays, baricitinib inhibited the activities of JAK1, JAK2, Tyrosine Kinase 2 and JAK3 with IC50 values of 5.9, 5.7, 53 and > 400 nM, respectively.
Maltese: F'analiżi ta' enzimi iżolati, baricitinib inibixxa l-attivitajiet ta' JAK1, JAK2, Tyrosine Kinase 2 u JAK3 b'valuri IC50 ta' 5.9, 5.7, 53 u > 400 nM, rispettivament.
English: Frequency estimate: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000
Maltese: Komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100).
English: Abbreviations: QD = Once daily; Q2W = Once every 2 weeks; SC = Subcutaneously; ACR = American College of Rheumatology; SDAI = Simplified Disease Activity Index; HAQ-DI = Health Assessment Questionnaire-Disability Index; mTSS = modified Total Sharp Score
Maltese: QD =Darba kuljum; Q2W =Darba kull ġimagħtejn; SC = Taħt il-ġilda; ACR = American College of Rheumatology; SDAI (Simplified Disease Activity Index) = Indiċi simplifikati tal-Attività tal-Marda; HAQ-DI (Health Assessment Questionnaire-Disability Index) = Kwestjonarju ta' Stima tas-Saħħa -Indiċi ta' Diżabilità; mTSS (modified Total Sharp Score) = Punteġġ totali ta' Sharp modifikat
English: Baricitinib treatment was associated with dose-dependent increases in lipid parameters including total cholesterol, triglycerides, LDL cholesterol, and HDL cholesterol.
Maltese: Trattament b'baricitinib kien assoċjat ma' żidiet li jiddependu mid-doża fil-parametri tal-lipidi inkluż kolesterol totali, trigliċeridi, kolesterol LDL, u kolesterol HDL.
English: • Placebo
Maltese: • Plaċebo
English: Abbreviations: ADA = adalimumab; MTX = methotrexate; OLU = Olumiant; PBO = Placebo * p ≤ 0.05; ** p ≤ 0.01; *** p ≤ 0.001 vs. placebo (vs. MTX for study RA-BEGIN) † p ≤ 0.05; †† p ≤ 0.01; ††† p ≤ 0.001 vs. adalimumab
Maltese: OLU = Olumiant; PBO = Plaċebo * p ≤ 0.05; ** p ≤ 0.01; *** p ≤ 0.001 vs. plaċebo (vs. MTX għall-istudju RA-BEGIN) † p ≤ 0.05; †† p ≤ 0.01; ††† p ≤ 0.001 vs. adalimumab
English: Film coating
Maltese: Żieda fil-piż
English: Pulmonary embolism
Maltese: Emboliżmu pulmonarju
English: Polyvinylchloride/polyethylene/polychlorotrifluoroethylene - aluminium blisters in cartons of 14, 28, 35, 56, 84 or 98 film-coated tablets.
Maltese: Folji tal-aluminju u tal-polyvinylchloride/polyethylene/polychlorotrifluoroethylene f'kartuna ta' 14, 28, 35, 56, 84 jew 98 pillola miksija b'rita.
English: In July 2019 VTE reporting rate was 0,13% compared to 0,09% in February 2019.
Maltese: F'Lulju 2019 ir-rata ta' rapurtaġġ ta' VTE kienet ta' 0,13% meta mqabbla ma' 0,09% fi Frar 2019.
English: Hepatic transaminases
Maltese: Transaminases epatiċi
English: Reporting rates for Olumiant compared to placebo for the infection-related ADRs were: Upper respiratory tract infections (14.7 % vs. 11.7 %), urinary tract infections (3.4 % vs. 2.7 %), gastroenteritis (1.6 % vs. 0.8 %), herpes simplex (1.8 % vs. 0.7 %), and herpes zoster (1.4 % vs. 0.4 %).
Maltese: Infezzjonijiet fil-parti ta' fuq tal-apparat tan-nifs (14.7% vs. 11.7%), infezzjonijiet fl-apparat talawrina (3.4% vs.2.7 %), gastroenterite (1.6% vs. 0.8%), erpete simplex (1.8% vs. 0.7%), u erpete zoster (1.4% vs. 0.4%).
English: Hypercholesterolaemiac
Maltese: Iperkolesterolemijac
English: Table 4: Response, Remission and Physical Function Study
Maltese: Tabella 4: Rispons, Remissjoni u Funzjoni Fiżika
English: ALT increased ≥3 x ULNc AST increased ≥3 x ULNc
Maltese: Żieda ta' ≥3 x ULN fl
English: Population (Number)
Maltese: Popolazzjoni (Numru)
English: RA-BEAM MTX-IR patients
Maltese: RA-BEAM pazjenti MTX-IR
English: Olumiant 2 mg and 4 mg are available in blister packs of 14, 28, 35, 56, 84 and 98 tablets in calendar blisters and 28 x 1 and 84 x 1 tablets in perforated unit dose blisters.
Maltese: Olumiant 2 mg u 4 mg huma disponibbli f'folji f'pakketti ta' 14, 28, 35, 56, 84 u 98 pillola f'folji kalendarju u 28 x 1 u 84 x 1 pillola f'folji b'sarbut toqob biex tinqata' doża waħda.
English: • Increased triglycerides ≥ 5.65 mmol/L: 0.4 % vs. 0.5 %, respectively
Maltese: • Żieda ≥ 5.65 mmol/L fit-triġliċeridi: 0.4% vs. 0.5%, rispettivament
English: Baricitinib is a selective and reversible inhibitor of Janus kinase (JAK)1 and JAK2.
Maltese: Baricitinib huwa inibitur selettiv u riversibbli ta' Janus kinase (JAK)1 u JAK2.
English: Cytochrome P450 enzymes
Maltese: Enzimi taċ-ċitokrom P450
English: In vitro, baricitinib is a substrate for organic anionic transporter (OAT)3, P-glycoprotein (Pgp), breast cancer resistance protein (BCRP) and multidrug and toxic extrusion protein (MATE)2-K.
Maltese: In vitro, baricitinib huwa sustrat għat-trasportatur tal-anjoni organiċi (OAT, organic anionic transporter) 3, għall-glikoproteina P (Pgp, P-glycoprotein), għall-proteina ta' reżistenza tal-kanċer tas sider (BCRP, breast cancer resistance protein) u għall-proteina ta' estrużjoni ta' ħafna mediċini u tossini (MATE, multidrug and toxic extrusion) 2-K.
English: • Increased HDL cholesterol ≥ 1.55 mmol/L: 42.7 % vs. 13.8 %, respectively
Maltese: • Żieda ≥ 1.55 mmol/L fil-kolesterol HDL: 42.7% vs. 13.8%, rispettivament
English: Neutropaenia <1 x 109 cells/Lc
Maltese: Newtropenija <1 x 109 ċelluli/Lc
English: For the total population, pneumococcal vaccination resulted in a satisfactory IgG immune response in 68.0 % (95 % CI: 58.4 %, 76.2 %) of the patients.
Maltese: Għall-popolazzjoni kollha, it-tilqim bil-vaċċin tal pnewmokokku rriżulta f'rispons immunitarju IgG sodisfaċenti f'68.0 % (95 % CI: 58.4 %, 76.2 %)
English: INFORMATION IN BRAILLE Olumiant 2 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Olumiant 2 mg
English: Week 24 0.14 0.06 0.03 0.29 0.12** Week 52 0.21 0.25 0.06 0.58 0.21*** 0.19** Proportion of patients with no radiographic progressionb:
Maltese: Ġimgħa 24 0.14 0.06 0.03 0.29 0.12** Ġimgħa 52 0.21 0.25 0.06 0.58 0.21*** 0.19** Proporzjon ta' pazjenti mingħajr l-ebda progressjoni radjugrafikab:
English: INFORMATION IN BRAILLE Olumiant 4 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Olumiant 4 mg
English: MARKETING AUTHORISATION HOLDER Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands.
Maltese: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, L-Olanda.
English: Swelling face (n=23) and urticaria (n=20) were also frequently reported.
Maltese: Nefħa fil-wiċċ (n=23) u urtikarja (n=20) kienu wkoll irrapportati b'mod frekwenti.
English: Herpes zoster, Herpes simplexb Gastroenteritis Urinary tract infections Pneumonia
Maltese: Erpete zoster Erpete simplexb Gastroenterite Infezzjonijiet fl-apparat tal-awrina
English: Week 24 68 % 76 % 81 %** 70 % 81 %*** 83 %*** 74 % 72 % 80 % Week 52 66 % 69 % 80 %** 70 % 79 %** 81 %**
Maltese: Ġimgħa 24 68 % 76 % 81 %** 70 % 81 %*** 83 %*** 74 % 72 % 80 % Ġimgħa 52 66 % 69 % 80 %** 70 % 79 %** 81 %** Taqsiriet:
English: Olumiant may be used as monotherapy or in combination with methotrexate (see sections 4.4, 4.5 and 5.1 for available data on different combinations).
Maltese: Olumiant jista' jintuża bħala monoterapija jew flimkien ma' methotrexate (ara sezzjonijiet 4.4, 4.5 u 5.1 għal dejta disponibbli dwar kombinazzjonijiet differenti).
English: Inhibition of IL-6 induced STAT3 phosphorylation
Maltese: Inibizzjoni tal-fosforilazzjoni ta' STAT3 ikkaġunata minn IL-6
English: tacrolimus or ciclosporin - other medicines belonging to the group of Janus kinase inhibitors, such as ruxolitinib
Maltese: tacrolimus jew ciclosporin - mediċini oħra li jagħmlu parti mill-grupp ta' inibitui ta' Janus kinase, bħal ruxolitinib
English: On background cDMARDs5
Maltese: Fuq cDMARDs5 fl-isfond