FrancophonIA/ELRC3.0 huggingface dataset:
English: You must contact your doctor immediately if you have any of the following early symptoms of allergic reactions: - rash, hives, wheals, generalised itching, - swelling of lips and tongue, - difficulty in breathing, wheezing, tightness in the chest, - general feeling of being unwell, - dizziness and loss of consciousness.
Maltese: Għandek tikkuntattja lit-tabib tiegħek minnufih jekk ikollok xi sintomi bikrija ta' reazzjonijiet allerġiċi li ġejjin: - raxx, ħorriqija, pustoli, ħakk ġenerali, - nefħa tax-xofftejn u l-ilsien, - diffikultà biex tieħu n-nifs, tħarħir, is-sider jingħafas,
English: • Do not try to administer the injection unless you have received special training from your doctor or nurse.
Maltese: • Tipprovax tagħti l-injezzjoni jekk ma ngħatajtx taħriġ speċjalizzat mit-tabib jew l-infermier/a tiegħek.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL FOR THE SOLVENT (BAXJECT III SYSTEM)
Maltese: Ż-ŻGĦAR EWLENIN TIKKETTA TAL-KUNJETT GAS-SOLVENT (SISTEMA BAXJECT III)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/004
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/03/271/004
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.
Maltese: Il-pazjenti għandhom ikunu mgħarrfa dwar sinjali bikrija ta' reazzjonijiet ta' sensittività eċċessiva li jinkludu ħorriqija, urtikarja ġeneralizzata, għafis tas-sider, tħarħir, pressjoni baxxa u anafilassi.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 1500 IU octocog alfa and 1 vial with 2 ml sterilised water for injections preassembled in BAXJECT III system.
Maltese: U KONTENUT Trab u solvent għal soluzzjoni għall-injezzjoni Kontenut: 1 kunjett b'1500 IU ta' octocog alfa u 1 kunjett b'2 ml ta' ilma sterilizzat għallinjezzjonijiet immuntati minn qabel f'sistema BAXJECT III.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 1000 IU octocog alfa and 1 vial with 2 ml sterilised water for injections preassembled in BAXJECT III system.
Maltese: U KONTENUT Trab u solvent għal soluzzjoni għall-injezzjoni Kontenut: 1 kunjett b'1000 IU ta' octocog alfa u 1 kunjett b'2 ml ta' ilma sterilizzat għallinjezzjonijiet immuntati minn qabel f'sistema BAXJECT III.
English: For the prevention of bleeding in children under the age of 6, doses of 20 to 50 IU per kg body weight 3 to 4 times weekly are recommended.
Maltese: F'pazjenti li għandhom inqas minn 6 snin, huma rrakkomandati d-dożi ta' 20 sa 50
English: IV use
Maltese: Għal użu IV
English: Do not use ADVATE - if you are allergic to octocog alfa or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to mouse or hamster proteins
Maltese: Tiħux ADVATE - jekk int allerġiku għal octocog alfa jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis-sezzjoni 6). - jekk int allerġiku/a għal proteini tal-ġurdien jew tal-ħamster.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 250 IU octocog alfa and 1 vial with 2 ml sterilised water for injections preassembled in BAXJECT III system.
Maltese: U KONTENUT Trab u solvent għal soluzzjoni għall-injezzjoni Kontenut: 1 kunjett b'250 IU ta' octocog alfa u 1 kunjett b'2 ml ta' ilma sterilizzat għallinjezzjonijiet immuntati minn qabel f'sistema BAXJECT III.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (BAXJECT II DEVICE)
Maltese: Ż-ŻGĦAR EWLENIN TIKKETTA TAL-KUNJETT GAS-SOLVENT (STRUMENT BAXJECT II)
English: Powder
Maltese: Sfurija
English: Pyrexia
Maltese: Rimettar
English: Place the ADVATE on a flat surface with the solvent vial on top (Fig. 1).
Maltese: Poġġi l-ADVATE fuq wiċċ ċatt bil-kunjett bis-solvent fuq (Fig. 1).
English: Disconnect the syringe.
Maltese: Aqla' s-siringa.
English: - submission of the variation by the Marketing Authorisation Holders of methadone tablets containing povidone of low molecular weight (K25 or K30)
Maltese: - preżentazzjoni tal-varjazzjoni midDetenturi tal-Awtorizzazzjoni għatTqegħid fis-Suq tal-pilloli talmethadone li fihom povidon b'piż molekulari baxx (K25 jew K30)
English: July 2014 CMDh meeting
Maltese: Laqgħa tas-CMDh Lulju 2014
English: 23 August 2014
Maltese: 23 ta' Awwissu 2014
English: Implementation of the agreement by the Member States: - suspension of the marketing authorisations of methadone oral solutions containing povidone of high molecular weight (K90)
Maltese: - sospensjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq tassoluzzjonijiet orali ta' methadone li fihom povidon b'piż molekulari għoli (K90)
English: Adoption of CMDh agreement:
Maltese: Implimentazzjoni tal-ftehim millIstati Membri:
English: Transmission to National Competent Authorities of the translations of the annexes to the agreement:
Maltese: Trażmissjoni lill-Awtoritajiet Nazzjonali Kompetenti tattraduzzjonijiet tal-annessi malftehim:
English: Protocol:
Maltese: Protokoll:
English: NL-2333 CB Leiden The Netherlands
Maltese: NL-2333 CB Leiden L-Olanda
English: See section 4.
Maltese: Ara t-taqsima 4.
English: 2333 CB Leiden The Netherlands
Maltese: 2333 CB Leiden L-Olanda
English: Siltuximab+BSC* Placebo+BSC 95% CIa
Maltese: Siltuximab+BSC* Plaċebo+BSC 95% CIa
English: (N/A; N/A)b
Maltese: (N/A; N/
English: 70 days
Maltese: 70 days c
English: Store in a refrigerator (2°C - 8°C).
Maltese: Aħżen fi friġġ (2°C sa 8°C).
English: Subgroup analyses
Maltese: Analiżi tas-sottogruppi
English: Janssen Sciences Ireland UC
Maltese: Janssen Sciences Ireland UC Barnahely
English: Siltuximab+BSC* Placebo+BSC P-valuea
Maltese: Siltuximab+BSC* Plaċebo+BSC Valur Pa
English: Date of first authorisation: 22 May 2014 Date of latest renewal: 2 April 2019
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 22 Mejju 2014
English: • The active substance is siltuximab.
Maltese: • Is-sustanza attiva hija siltuximab.
English: Excipients: histidine, histidine hydrochloride monohydrate, polysorbate 80, sucrose.
Maltese: TA' EĊĊIPJENTI Eċċipjenti: histidine, histidine hydrochloride monohydrate, polysorbate 80, sucrose
English: Johannes Vermeerplein 11 1071 DV
Maltese: Johannes Vermeerplein 11
English: Hypoglobulinaemia was observed in 4 to 11.3% of patients in the clinical study.
Maltese: Ipoglobulinemija kienet osservata f'minn 4 sa 11.3% tal-pazjenti fl-istudju kliniku.
English: In non-clinical studies, interleukin-6 (IL-6) is known to decrease the activity of cytochrome P450 (CYP450).
Maltese: Fi studji li mhumiex kliniċi, interleukin-6 (IL-6) huwa magħruf li jnaqqas l-attività taċ-ċitokroma P450 (CYP450 - cytochrome P450).
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa ta' eċċipjenti, ara t-taqsima 6.1.
English: SYLVANT should remain at room temperature for the duration of the preparation.
Maltese: SYLVANT għandu jibqa' f'temperatura tal-kamra matul il-preparazzjoni kollha.
English: 3 weeks.
Maltese: 3 snin
English: (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8)
Maltese: human immunodeficiency virus) u negattivi għall-virus tal-erpete 8 umana (HHV-8 - human herpesvirus-8).
English: Infusion related reactions and hypersensitivity
Maltese: Reazzjonijiet marbuta mal-infużjoni u sensittività eċċessiva
English: Neutropenia, thrombocytopenia
Maltese: Newtropenija, tromboċitopenija
English: Table 3: Efficacy endpoints from study 1 Efficacy endpoints
Maltese: Tabella 3: Skopijiet finali ta' effikaċja minn studju 1 Skopijiet finali ta' effikaċja
English: ECOG performance status score (0/1/2) at baseline was 42%/45%/13% in the siltuximab arm and 39%/62%/0% in the placebo arm, respectively.
Maltese: Il-punteġġ tal-istat ta' eżekuzzjoni ECOG (0/1/2) fil-linja bażi kien 42%/45%/13% fil-fergħa ta' siltuximab u 39%/62%/0% fil-fergħa tal-plaċebo, rispettivament.
English: Use aseptic technique.
Maltese: Uża teknika asettika.
English: Localised oedema
Maltese: Edima lokalizzata
English: Siltuximab is a chimeric (human-murine) immunoglobulin G1κ (IgG1κ) monoclonal antibody produced in a Chinese hamster ovary (CHO) cell line by recombinant DNA technology.
Maltese: Siltuximab huwa antikorp monoklonali immunoglobulina G1κ (IgG1κ) kimeriku (uman-murine) manifatturat f'linja ta' ċelluli tal-ovarju tal-ħamster Ċiniż (CHO - Chinese hamster ovary) permezz ta' teknoloġija ta' DNA rikombinata.
English: In Study 1 a statistically significant difference in independently reviewed durable tumour and symptomatic response rate in the siltuximab arm compared with the placebo arm (34% vs. 0%, respectively; 95% CI: 11.1, 54.8; p = 0.0012) was observed.
Maltese: Fi Studju 1 kienet osservata differenza sinifikanti b'mod statistiku, b'analiżi indipendenti, fir-rata ta' rispons li jdum iservi għat-tumur u għas-sintomi fil-fergħa ta' siltuximab meta mqabbla mal-fergħa tal-plaċebo (34% vs. 0%, rispettivament; 95% CI: 11.1, 54.8; p = 0.0012).
English: • Use aseptic technique.
Maltese: • Uża teknika asettika.
English: A total score of all symptoms (referred to as the MCD-related Overall Symptom Score) is the sum of the severity grades (NCI-CTCAE grade) of the MCD-related signs and symptoms [general MCD-related (fatigue, malaise, hyperhidrosis, night sweats, fever, weight loss, anorexia, tumour pain, dyspnea, and pruritus), autoimmune phenomena, fluid retention, neuropathy, and skin disorders].
Maltese: Punteġġ totali tas-sintomi kollha (imsejjaħ il-Punteġġ tas-Sintomi Kollha marbuta ma' MCD) huwa l-għadd tal-gradi ta' severità (grad NCI-CTCAE) tas-sinjali u s-sintomi marbuta ma' MCD [ġenerali marbuta ma' MCD (għeja, tħossok ma tiflaħx mingħajr kawża partikolari, iperidrosi, għaraq bil-lejl, deni, telf ta' piż, anoressija, uġigħ tat-tumur, qtugħ ta' nifs u ħakk), fenomeni awtoimmuni, żamma tal-fluwidu, newropatija, u disturbi fil-ġilda].
English: SYLVANT 400 mg powder for concentrate for solution for infusion EU/1/14/928/002
Maltese: SYLVANT 400 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni EU/1/14/928/002
English: Histological subtype was similar in both treatment arms, with 33% hyaline vascular subtype, 23% plasmacytic subtype and 44% mixed subtype.
Maltese: Is-sottotip istoloġiku kien jixxiebah fiżżewġ fergħat ta' kura, bi 33% b'sottotip hyaline vaskulari, 23% b'sottotip plażmaċitiku u 44% b'sottotip imħallat.
English: Siltuximab (9.2 and 46 mg/kg/week) did not produce any toxicity of the reproductive tract in cynomolgus monkeys.
Maltese: Siltuximab (9.2 u 46 mg/kg/ġimgħa) ma pproduċa l-ebda tossiċità fil-passaġġ riproduttiv ta' xadini cynomolgus.
English: SYLVANT may mask signs and symptoms of acute inflammation including suppression of fever and of acute-phase reactants, such as C-reactive protein (CRP).
Maltese: SYLVANT jista' jaħbi sinjali u sintomi ta' infjammazzjoni akuta inkluż soppressjoni ta' deni u ta' prodotti ta' reazzjonijiet tal-fażi akuta, bħall-proteina C reattiva (CRP - C-reactive protein).
English: Histidine hydrochloride monohydrate Polysorbate 80
Maltese: Histidine hydrochloride monohydrate
English: 30/11/2015 (aligned with expected PSUR cycle)
Maltese: 30/11/2015 (fl-istess żmien taċ-ċiklu mistenni tal-PSUR)
English: Pharmacotherapeutic group: Immunosuppresants, interleukin inhibitors, ATC code: L04AC11.
Maltese: Immunosoppressanti, inibituri ta' interleukin, Kodiċi ATC:
English: UNIQUE IDENTIFIER - 2D BARCODE
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D < barcode 2D li jkollu l-identifikatur uniku inkluż.>
English: At baseline, 55% of patients in the siltuximab arm and 65% of patients in the placebo arm had received prior systemic therapies for MCD and 30% of patients in the siltuximab arm and 31% in the placebo arm were using corticosteroids.
Maltese: Fil-linja bażi, 55% tal-pazjenti fil-fergħa ta' siltuximab u 65% tal-pazjenti fil-fergħa tal-plaċebo kienu rċivew terapiji sistemiċi qabel għal MCD u 30% tal-pazjenti fil-fergħa ta' siltuximab u 31% fil-fergħa tal-plaċebo kienu qed jużaw kortikosterojdi.
English: Siltuximab is a monoclonal antibody (a specialised type of protein) that binds selectively to an antigen (a target protein) in the body called interleukin-6 (IL-6).
Maltese: Siltuximab huwa antikorp monoklonali (tip ta' proteina speċjalizzata) li jintrabat b'mod selettiv ma' antiġen (proteina fil-mira) fil-ġisem imsejjaħ interleukin-6 (IL-6).
English: Infections (including upper respiratory tract infections), pruritus, rash, arthralgia, and diarrhoea were the most common adverse reactions , occurring in > 20% of siltuximab-treated patients in Castleman's disease (CD) clinical studies.
Maltese: Infezzjonijiet (inkluż infezzjonijiet tan-naħa ta' fuq tal-apparat tan-nifs), ħakk, raxx, artralġja, u dijarea kienu l-aktar reazzjonijiet avversi komuni, li seħħew f'> 20% tal-pazjenti ttrattati b'siltuximab fi studji kliniċi tal-marda ta' Castleman (CD - Castleman's disease).
English: • cyclosporin, used during and after organ transplants
Maltese: • cyclosporin, jintuża waqt u wara trapjanti ta' organi
English: HR 0.418
Maltese: L04AC11.
English: In long-term treatment of MCD patients with siltuximab at the recommended dosage of 11 mg/kg every 3 weeks, infusion related reactions or hypersensitivity reactions occurred at a frequency of 6.3% (1.3% for severe reactions).
Maltese: Fit-trattament fit-tul ta' pazjenti b'MCD b'siltuximab bid-dożaġġ rrakkomandat ta' 11-il mg/kg kull 3 ġimgħat, reazzjonijiet relatati mal-infużjoni jew reazzjonijiet ta' sensittività eċċessiva seħħew bi frekwenza ta' 6.3% (1.3% għal reazzjonijiet severi).
English: SYLVANT is a medicine that contains the active substance siltuximab.
Maltese: SYLVANT huwa mediċina li fiha s-sustanza attiva siltuximab.
English: A statistically significant difference (61.3% vs. 0% respectively; p = 0.0002) in the haemoglobin response in the siltuximab arm compared with the placebo arm was observed.
Maltese: Kienet osservata differenza sinifikanti b'mod statistiku (61.3% vs. 0% rispettivament; p = 0.0002) fir-rispons tal-emoglobina fil-fergħa ta' siltuximab meta mqabbla mal-fergħa tal-plaċebo.
English: Immune system disorders common
Maltese: Disturbi fis-sistema immuni komuni
English: The highest total amount of siltuximab administered in any clinical trial so far per dose was 2,190 mg (11 mg/kg).
Maltese: L-ogħla ammont totali ta' siltuximab li ngħata fi kwalunkwe prova klinika sal-lum f'kull doża kien ta' 2,190 mg (11 mg/kg).
English: For patients with baseline alanine transaminase up to 3.7 times the upper limit of normal baseline albumin ranging from 15 to 58 g/L, and baseline bilirubin ranging from 1.7 to 42.8 mg/dL there was no meaningful effect on siltuximab PK.
Maltese: Għal pazjenti b'linja bażi ta' alanine transaminase sa 3.7 drabi l-ogħla limitu tan-normal, llinja bażi tal-albumina fuq medda minn 15 sa 58 g/L, u l-linja bażi tal-bilirubin fuq medda minn 1.7 sa 42.8 mg/dL ma kien hemm l-ebda effett ta' sinifikat fuq il-PK ta' siltuximab.
English: • urinary tract infection
Maltese: • infezzjoni tal-passaġġ urinarju
English: • Allow vial(s) of SYLVANT to come to room temperature (15°C to 25°C) over approximately 30 minutes.
Maltese: • Ħalli l-kunjett(i) ta' SYLVANT jilħaq(qu) it-temperatura tal-kamra (15°C sa 25°C) fuq perjodu ta' madwar 30 minuta.
English: Highest total dose in clinical trials
Maltese: L-ogħla doża totali fi provi kliniċi
English: Table 4: Select efficacy endpoints for hyaline vascular subgroup from study 1 Efficacy endpoints
Maltese: Tabella 4: Skopijiet finali ta' effikaċja magħżula għas-sottogrupp ta' hyaline vaskulari minn studju 1
English: The immunogenicity of siltuximab has been evaluated using antigen-bridging enzyme immunoassay (EIA) and electrochemiluminescence (ECL)-based immunoassay (ECLIA)
Maltese: L-immunoġeniċità ta' siltuximab kienet stmata bl-użu tal-metodi ta' immunoassaġġ b'enzima li tintrabat ma' antigen (EIA - enzyme immunoassay) u immunoassaġġ (ECLIA) abbażi ta' electrochemiluminescence (ECL).
English: Analyses for both primary and secondary endpoints on various subgroups including age (< 65 years and ≥ 65 years); race (White and Non-White); region (North America, Europe, Middle East and Africa, and Asia Pacific); baseline corticosteroid use (yes and no); prior therapy (yes and no); and MCD histology (plasmatic and mixed histology) consistently showed that the treatment effect favoured the siltuximab arm except for the hyaline vascular subgroup in which no patient achieved the definition of the primary endpoint.
Maltese: Analiżi kemm għall-iskopijiet finali primarji kif ukoll sekondarji fuq diversi sottogruppi fosthom l-età (< 65 sena u ≥ 65 sena); ir-razza (Bojod u Mhux Bojod); ir-reġjun (l-Amerika ta' Fuq, l-Ewropa, ilLvant Nofsani u l-Afrika, u l-pajjiżi fl-Asja-Paċifiku); l-użu ta' kortikosterojdi fil-linja bażi (iva u le); terapija qabel (iva u le); u l-istoloġija ta' MCD (istoloġija plasmatika u mħallta) urew b'mod konsistenti li l-effett tal-kura ffavorixxa l-fergħa ta' siltuximab ħlief għas-sottogrupp tal-hyaline vaskulari li fih l-ebda pazjent ma kiseb id-definizzjoni tal-iskop finali primarju.
English: Haemoglobina
Maltese: Emoglobinaa
English: The population PK of siltuximab were analysed to evaluate the effects of demographic characteristics.
Maltese: Il-PK tal-popolazzjoni ta' siltuximab kienet analizzata biex jiġu stmati l-effetti tal-karatteristiċi demografiċi.
English: Allow vial(s) of SYLVANT to come to room temperature (15°C to 25°C) over approximately 30 minutes.
Maltese: Ħalli l-kunjett(i) ta' SYLVANT jilħaq(u) t-temperatura tal-kamra (15°C sa 25°C) fuq perjodu ta' madwar 30 minuta.
English: Serious infections, including pneumonia and sepsis, were observed during clinical studies (see section 4.8).
Maltese: Infezzjonijiet serji, fosthom pulmonite u sepsi, kienu osservati waqt studji kliniċi (ara t-taqsima 4.8).
English: Nervous system disorders very common
Maltese: Disturbi fis-sistema nervuża komuni ħafna
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit web tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu.
English: It is well established that IL-6 stimulates the acute-phase expression of C-reactive protein (CRP).
Maltese: Huwa fatt stabbilit li IL-6 jistimula l-espressjoni fil-fażi akuta tal-proteina reattiva C (CRP - Creactive protein).
English: IL-6 has been shown to be involved in diverse normal physiologic processes such as induction of immunoglobulin secretion, initiation of hepatic acute phase protein synthesis, and stimulation of hematopoietic precursor cell proliferation and differentiation.
Maltese: IL-6 intwera li huwa involut f'varjetà ta' proċessi fiżjoloġiċi normali bħal induzzjoni ta' sekrezzjoni ta' immunoglobulina, bidu tal-fażi akuta ta' sintesi ta' proteini mill-fwied, u stimulu tal-proliferazzjoni u d-divrenzjar taċċelluli prekursuri ta' dawk ematopoetiċi.
English: Infections and infestations very common
Maltese: Infezzjonijiet u infestazzjonijiet komuni ħafna
English: The recommended needle for preparation is 21-gauge 1½ inch (38 mm).
Maltese: Il-labra rrakkomandata għall-preparazzzjoni hija 21-gauge tal-pulzier u nofs (38 mm).
English: Nausea, abdominal pain, vomiting, constipation, diarrhoea, gastroesophageal reflux disease, mouth ulceration
Maltese: Nawsja, uġigħ fl-addome, rimettar, stitikezza, dijarea, marda ta' rifluss gastrosefagali, ulċeri fil-ħalq
English: In this study 37 patients with CD (35 MCD patients) were treated with siltuximab.
Maltese: F'dan l-istudju 37 pazjent b'CD (35 pazjent b'MCD) ġew ikkurati b'siltuximab.
English: • warfarin, a blood thinner
Maltese: • warfarin, iraqqaq id-demm
English: Other medicines and SYLVANT
Maltese: Mediċini oħra u SYLVANT
English: SYLVANT is used to treat multicentric Castleman's disease (MCD) in adult patients who do not have human immunodeficiency virus (HIV) or human herpesvirus-8 (HHV-8) infection.
Maltese: SYLVANT jintuża biex jikkura l-marda multiċentrika ta' Castleman (MCD - multicentric Castleman's disease) f'pazjenti adulti li m'għandhomx il-virus tal-immunodefiċjenza umana (HIV - human immunodeficiency virus) jew il-virus tal-erpete 8 umana (HHV-8 - human herpesvirus-8).
English: • Dilute the total volume of the reconstituted solution dose to 250 mL with sterile dextrose 5%, by withdrawing a volume equal to the volume of reconstituted SYLVANT from the dextrose 5%, 250 mL bag.
Maltese: • Iddilwi l-volum totali tad-doża tas-soluzzjoni rrikostitwita sa 250 mL b'dextrose 5% sterili, billi mill-borża ta' 250 mL tas-soluzzjoni ta' dextrose 5%, tiġbed volum li huwa daqs il-volum ta' SYLVANT irrikostitwit.
English: Decreases in total IgG, IgA, or IgM levels below normal were observed in the range of 4 to 11%
Maltese: Kien osservat tnaqqis fil-livelli totali ta' IgG, IgA, jew IgM taħt in-normal ivarja f'minn 4 sa 11% ta' pazjenti fil-prova tal-MCD (Studju 1).
English: Musculoskeletal and connective tissue disorders very common
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi komuni ħafna
English: In this study, 16 of the 35 MCD patients were hyaline vascular subtype; 31% of these patients had a radiologic response based on independent review and 88% showed clinical benefit response as defined in the protocol.
Maltese: F'dan l-istudju, 16 mill-35 pazjent b'MCD kienu tas-sottotip hyaline vaskulari; 31% minn dawn il-pazjenti kellhom rispons radjoloġiku abbażi ta' analiżi indipendenti u 88% urew rispons ta' benefiċċju kliniku kif iddefinit fil-protokoll.
English: Infusion bags (250 mL) must contain Dextrose 5% and must be made of polyvinyl chloride (PVC), or polyolefin (PO), or polypropylene (PP), or polyethylene (PE).
Maltese: Boroż tal-infużjoni (250 mL) għandu jkun fihom Dextrose 5% u għandhom jkunu magħmulin mill-polyvinyl chloride (PVC), jew polyolefin (PO), jew polypropylene (PP), jew polyethylene (PE).
English: • During the infusion with SYLVANT, you will be monitored for side effects.
Maltese: • Waqt l-infużjoni b'SYLVANT, inti se tiġi ssorveljat għal effetti sekondarji.
English: In clinical studies, siltuximab was associated with an infusion related reaction or hypersensitivity reaction in 5.1% (severe reaction in 0.8%) of patients treated with siltuximab monotherapy.
Maltese: Fi studji kliniċi, siltuximab kien assoċjat ma' reazzjoni marbuta mal-infużjoni jew reazzjoni ta' sensittività eċċessiva f'5.1% (reazzjoni qawwija f'0.8%) tal-pazjenti kkurati b'monoterapija ta' siltuximab.
English: Following the single dose administration at the recommended dose regimen (11 mg/kg given once every 3 weeks), the clearance was 3.54 ± 0.44 mL/kg/day and half-life was 16.3 ± 4.2 days.
Maltese: Wara l-għoti ta' doża waħda bl-iskeda ta' għoti tad-doża rrakkomandata (11-il mg/kg mogħtija darba kull 3 ġimgħat), it-tneħħija kienet 3.54 ± 0.44 mL/kg/jum u l-half-life kienet ta' 16.3 ± 4.2 jum.
English: Investigations very common
Maltese: Investigazzjonijiets komuni ħafna
English: Binding bioactive IL-6 by siltuximab may result in increased metabolism of CYP450 substrates, because CYP450 enzyme activity will normalise.
Maltese: L-irbit ta' IL-6 bijoattiv minn siltuximab jista' jwassal għal żieda fil metaboliżmu ta' sustrati ta' CYP450, minħabba li l-attività tal-enżima CYP450 tiġi lura għan-normal.
English: Haemoglobin increase > 15 g/L (0.9 mmol/L) at Week 13/haemoglobin response-evaluable population Durable complete symptomatic responsed
Maltese: Żieda fl-emoglobina > 15 g/L (0.9 mmol/L) fil-Ġimgħa 13/popolazzjoni b'rispons għall-emoglobina li jista' jitkejjel
English: Table 2: Adverse reactions in siltuximab treated patients in MCD clinical studies a
Maltese: Tabella 2: Reazzjonijiet avversi f'pazjenti kkurati b'siltuximab fi studji kliniċia ta' MCD Klassi tas-sistemi u tal-organi
English: Respiratory, thoracic and mediastinal disorders very common
Maltese: Disturbi respiratorji, toraċiċi u medjastinali komuni ħafna