FrancophonIA/ELRC3.0 huggingface dataset:
English: The primary analysis showed that 80% of patients in the Mozobil arm experienced at least a doubling of the PB CD34+ count, observed from the morning of the day preceding the first planned apheresis to the morning prior to apheresis, versus, 28.6 % of patients in the control arm (p=0.0019).
Maltese: L-analiżi primarja wriet li 80% tal-pazjenti fil-fergħa ta' Mozobil kellhom mill-inqas irduppjar tal-għadd ta' PB CD34+, osservat minn filgħodu tal-ġurnata qabel l-ewwel afereżi ppjanata sa filgħodu ta' qabel l-afereżi kontra, 28.6 % tal-pazjenti fil-fergħa ta' kontroll (p=0.0019).
English: VIAL
Maltese: Paasheuvelweg
English: Each ml contains 20 mg plerixafor.
Maltese: Kull ml ta' soluzzjoni għall-injezzjoni fiha 20 mg ta' plerixafor.
English: Lack of temporal relationship in 8 of 9 patients coupled with the risk profile of patients with myocardial infarction does not suggest Mozobil confers an independent risk for myocardial infarction in patients who also receive G-CSF.
Maltese: Nuqqas ta' relazzjoni temporali fi 8 minn 9 pazjenti, flimkien mal-profil tar-riskju ta' pazjenti b'infart mijokardijaku ma jissuġġerixxix li Mozobil jikkawża riskju indipendenti għal infart mijokardijaku f'pazjenti li jirċievu G-CSF ukoll.
English: cells/kg in ≤ 2 apheresis days with Mozobil and G-CSF (n=106; 71.6%) than with placebo and G-CSF (n=53; 34.4%), p<0.001; statistically significantly more patients achieved ≥ 6 x 10
Maltese: (n=106; 71.6%) milli bil-plaċebo u G-CSF (n=53; 34.4%), p<0.001; aktar pazjenti b'mod statistikament sinfikanti kisbu ≥ 6 x 106 ċelluli/kg f'≤ 4 ijiem ta' aferesi b'Mozobil u G-CSF (n=112; 75.7%) milli bil-plaċebo u G-CSF (n=79; 51.3%),
English: Very common Diarrhoea, nausea
Maltese: Komuni ħafna Dijarea, dardir
English: Plerixafor inhibited tumour growth in in vivo models of non-Hodgkin's lymphoma, glioblastoma, medulloblastoma, and acute lymphoblastic leukaemia when dosed intermittently.
Maltese: Plerixafor inibixxa t-tkabbir ta' tumuri f'mudelli in vivo ta' limfoma mhux ta' Hodgkin, glioblastoma, medulloblastoma u lewkimja limfoblastika akuta, meta ngħatat doża intermittenti.
English: Body weight of 83 kg was selected as the cut-off point to transition patients from fixed to weight based dosing (83 kg x 0.24 mg = 19.92 mg/kg).
Maltese: Ġie magħżul piż ta' 83 kg bħala l-punt fejn pazjenti jgħaddu minn dożaġġ fiss għal wieħed ibbażat fuq il-piż (83 kg x 0.24 mg = 19.
English: In two Phase III randomised-controlled studies patients with non-Hodgkin's lymphoma or multiple myeloma received Mozobil 0.24 mg/kg or placebo on each evening prior to apheresis.
Maltese: III, pazjenti b'limfoma mhux ta' Hodgkin jew b'majeloma multipla, irċivew Mozobil 0.24 mg/kg jew plaċebo kull filgħaxija qabel l-aferesi.
English: Plerixafor did not act as a substrate or inhibitor of P-glycoprotein in an in vitro study with MDCKII and MDCKII-MDR1 cell models.
Maltese: Mozobil fih is-sustanza attiva plerixafor li timblokka proteina fuq il-wiċċ ta' ċelluli staminali taddemm.
English: Safety pharmacology studies with intravenously administered plerixafor in rats showed respiratory and cardiac depressant effects at systemic exposure slightly above the human clinical exposure, whilst subcutaneous administration elicited respiratory and cardiovascular effects only at higher systemic levels.
Maltese: Studji dwar is-sigurtà farmakoloġika b'plerixafor mogħti minn ġol-vina fil-firien urew effetti dipressanti fuq is-sistema respiratorja u kardijaka f'espożizzjonijiet sistemiċi li kienu ftit aktar millespożizzjoni klinka fil-bniedem, filwaqt li meta ġie mogħti minn taħt il-ġilda l-effetti dipressanti fuq is-sistema respiratorja u dik kardjovaskulari dehru biss b'livelli sistemiċi ogħla.
English: For transplanted patients in the Phase III studies, median time to neutrophil engraftment (10-11 days), median time to platelet engraftment (18-20 days) and graft durability up to 12 months post-transplantation were similar across the Mozobil and placebo groups.
Maltese: III, iż-żmien medjan għall-engraftment tan-newtrofili (10-11-il jum), iż-żmien medjan għall-engraftment tal-plejtlits (18-20 jum) u żmien kemm dam effettiv ittrapjant sa 12-il xahar wara t-trapjant, kienu simili fil-gruppi kollha ta' Mozobil u l-plaċebo.
English: Adverse reactions are listed by System Organ Class and frequency.
Maltese: Ir-reazzjonijiet avversi huma mniżżla skont is-Sistema tal-Klassifika tal-Organi u l-frekwenza.
English: From chemotherapy/ablative treatment in preparation of transplantation through 12 months post-transplantation, no significant differences in the incidence of adverse reactions were observed across treatment groups.
Maltese: Mill-kura kimoterpewtika/ablativa bħala preparazzjoni għat-trapjant, sa 12-il xahar wara t-trapjant, ma kienu osservati l-ebda differenzi sinifikanti fl-inċidenza ta' reazzjonijiet fil-gruppi tal-kura.
English: These findings suggest that plerixafor has a low potential for involvement in P450-dependent drug-drug interactions.
Maltese: Dawn is-sejbiet jissuġġerixxu li plerixafor għandu potenzjal baxx għal involviment f'interazzjonijiet bejn mediċina u oħra li jiddependu fuq P450.
English: Additionally, two female oncology patients in the compassionate use programme experienced myocardial infarction following haematopoietic stem cell mobilisation with plerixafor and G-CSF.
Maltese: Flimkien ma' dan, żewġ pazjenti tal-onkoloġija nisa, filprogramm għall-użu kompassjonali, kellhom infart mijokardijaku wara mobilizzazzjoni taċ-ċelluli staminali ematopojetiċi bi plerixafor u G-CSF.
English: The recommended adult dose is either a 20 mg (fixed dose) or 0.24 mg/kg body weight/day.
Maltese: Id-doża rrakkomandata fl-adulti hija ta' jew 20 mg (doża fissa) jew 0.24 mg/kg ta' piż talġisem/kuljum.
English: In pharmacodynamic studies in healthy volunteers of plerixafor alone, peak mobilisation of CD34+ cells was observed from 6 to 9 hours after administration.
Maltese: Fi studji farmakodinamiċi b'plerixafor mogħti waħdu f'voluntiera b'saħħithom, l-ogħla mobilizzazzjoni taċ-ċelluli CD34+ kienet osservata minn 6 sa 9 sigħat wara l-għoti.
English: Systemic Exposure (AUC0-10h) comparisons of fixed and weight based regimens
Maltese: Paragun ta' Espożizzjonijiet Sistemiċi (AUC0-10h) ta' skedi ta' dożaġġ fiss u bbażat fuq il-piż
English: Additional effects of plerixafor consistently noted in repeated dose animal studies included increased levels of circulating white blood cells and increased urinary excretion of calcium and magnesium in rats and dogs, slightly higher spleen weights in rats, and diarrhoea and tachycardia in dogs.
Maltese: Effetti addizzjonali ta' plerixafor li kienu osservati b'mod konsistenti fi studji b'dożi ripetuti fl-annimali kienu jinkludu żieda fil-livelli ta' ċelluli bojod taddemm fiċ-ċirkolazzjoni u żieda fl-ammont ta' tneħħija ta' calcium u magnesium mill-awrina fil-firien u l-klieb, piżijiet ftit ogħla tal-milsa fil-firien u dijarea u takikardija fil-klieb.
English: For the purpose of haematopoietic stem cell mobilisation, plerixafor may cause mobilisation of leukaemic cells and subsequent contamination of the apheresis product.
Maltese: Għall-iskop tal-mobilizzazzjoni taċ-ċelluli staminali ematopojetiċi, plerixafor jista' jikkawża l-mobilizzazzjoni ta' ċelluli lewkemiċi u kontaminazzjoni sussegwenti tal-prodott tal-aferesi.
English: Plerixafor dose and treatment of patients weighing more than 175% of ideal body weight have not been investigated.
Maltese: Id-doża ta' Plerixafor u l-kura ta' pazjenti li jiżnu iktar minn 175% tal-piż ideali tal-ġisem ma kinux investigati.
English: Mobilisation and engraftment data from supportive Phase II studies (plerixafor 0.24 mg/kg dosed on the evening or morning prior to apheresis) in patients with non-Hodgkin's lymphoma, Hodgkin's disease, or multiple myeloma were similar to those data for the Phase III studies.
Maltese: Id-dejta dwar il-mobilizzazzjoni u l-engraftment minn studji ta' appoġġ ta' Fażi II (doża ta' plerixafor ta' 0.24 mg/kg mogħtija filgħaxija jew filgħodu qabel l-aferesi) f'pazjenti b'limfoma mhux ta' Hodgkin, bil-marda ta' Hodgkin, jew b'majeloma multipla, kienu simili għad-dejta tal-istudji ta' Fażi
English: Do not use Mozobil
Maltese: Tużax Mozobil
English: Hyperleukocytosis
Maltese: Indeboliment tal-kliewi
English: cells/kg by apheresis day in non-Hodgkin's lymphoma patients
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Renal impairment had no effect on Cmax..
Maltese: L-indeboliment tal-kliewi ma kellu l-ebda effett fuq is-Cmax.
English: One ml of solution contains 20 mg plerixafor.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull ml fih 20 mg ta' plerixafor.
English: During that 24-hour period, the first dose of plerixafor 0.24 mg/kg or placebo was administered 10-11 hours prior to apheresis.
Maltese: Matul dak il-perijodu ta' 24 siegħa, l-ewwel doża ta' plerixafor 0.24 mg/kg jew plaċebo ngħatat 10-11-il siegħa qabel l-aferesi.
English: CD34+ cells/kg was 3 days for both treatment groups, and the safety profile between the groups was similar.
Maltese: Iż-żmien medjan sabiex jintlaħaq ≥ 5 × 106 CD34+ cells/kg kien ta' 3 ijiem għaż-żewġ gruppi ta' trattament, u l-profil ta' sigurtà bejn il-gruppi kien simili.
English: Eesti sanofi-aventis Estonia OÜ Tel. +372 6 273 488
Maltese: Slovenija sanofi-aventis d.o.o. Tel: +386 1 560 4800
English: cells/kg) numbers of CD34+ cells/kg within a given number of days, as well as the primary composite endpoints which incorporated successful engraftment are presented in Tables 3 and 5; the proportion of patients reaching optimal numbers of CD34+ cells/kg by apheresis day are presented in Tables 4 and 6.
Maltese: L-aħjar ammonti (5 jew 6 x 106 ċelluli/kg) u l-inqas ammont (2 x 106 ċelluli/kg) ta' ċelluli CD34+/kg f'perijodu ta' numru stabbilit ta' jiem, kif ukoll varji endpoints primarji, li kienu jinkorporaw engraftment li rnexxa, huma ppreżentati f'Tabella 3 u 5; il-proporzjon ta' pazjenti li kisbu l-aħjar ammonti ta' ċelluli CD34+/kg sal-jum tal-aferesi huma ppreżentati f'Tabella 4 u 6.
English: Safety data for Mozobil in conjunction with G-CSF in oncology patients with lymphoma and multiple myeloma were obtained from 2 placebo-controlled Phase III studies (301 patients) and 10 uncontrolled Phase II studies (242 patients).
Maltese: III kkontrollati bil-plaċebo (301 pazjenti) u 10 studji mhux ikkontrollati ta' Fażi
English: Thrombocytopenia
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: 9/L.
Maltese: U L-UŻU.
English: Common Hyperhidrosis, erythema Musculoskeletal and connective tissue disorders Common Arthralgia, musculoskeletal pain General disorders and administration site conditions Very common Injection and infusion site reactions Common Fatigue, malaise
Maltese: Jekk il-mobilizzazzjoni hija fqira, Mozobil jintuża biex jgħin jiġbor iċ-ċelluli staminali tad-demm millpazjent, għal ġbir, ħażna u re-introduzzjoni (trapjant),
English: cells/kg in ≤ 4 apheresis days with Mozobil and G-CSF (n=112; 75.7%) than with placebo and G-CSF (n=79; 51.3%), p<0.001; statistically significantly more patients achieved ≥ 2 x 10
Maltese: ċelluli/kg f'≤ 4 ijiem ta' aferesi u engraftment li rnexxa a valur p ikkalkulat bl-użu ta' Pearson's Chi-Squared test b Aktar pazjenti b'mod statistikament sinfikanti kisbu ≥ 5 x 106 ċelluli/kg fi ≤ 4 ijiem ta' aferesi b'Mozobil u G-CSF (n=89; 59.3%) milli bil-plaċebo u G-CSF (n=29; 19.6%), p<0.001; aktar pazjenti b'mod statistikament sinfikanti kisbu ≥ 2 x 106 ċelluli/kg fi ≤ 4 ijiem ta' aferesi b'Mozobil u G-CSF (n=130; 86.7%) milli bil-plaċebo u G-CSF (n=70; 47.
English: cells/kg in ≤ 4 apheresis days and successful engraftment Patients achieving ≥ 2 x 10
Maltese: ċelluli/kg f'≤ 4 ijiem ta' aferesi u engraftment li rnexxa
English: Mozobil and G-CSF (n = 148)
Maltese: (n = 148)
English: No complications or clinical symptoms of leukostasis were observed.
Maltese: Ma kienu osservati l-ebda kumplikazzjonijiet jew sintomi kliniċi ta' lewkostasi.
English: Of these patients, 55 % (34 out of 62) mobilised ≥ 2 x10
Maltese: Minn dawn ilpazjenti, 55% (34 minn 62) immobilizzaw ≥ 2 x106/kg ċelluli CD34+ u kellhom engrafting b'suċċess.
English: There was an imbalance between treatment arms in peripheral blood CD34+ counts on the day prior to first apheresis (i.e. prior to administration of plerixafor), with less circulating PB CD34+ in the plerixafor arm.
Maltese: Kien hemm żbilanċ bejn il-fergħat ta' trattament fl-għadd ta' CD34+ fid-demm periferali fil-ġurnata qabel l-ewwel afereżi (jiġifieri qabel l-għoti ta' plerixafor), b'inqas PB CD34+ fiċċirkolazzjoni fil-fergħa ta' plerixafor.
English: Tumour cell mobilisation in patients with lymphoma and multiple myeloma When Mozobil is used in conjunction with G-CSF for haematopoietic stem cell mobilisation in patients with lymphoma or multiple myeloma‚ tumour cells may be released from the marrow and subsequently collected in the leukapheresis product.
Maltese: Meta Mozobil jintuża flimkien ma' G-CSF għal mobilizzazzjoni ta' ċelluli staminali ematopojetiċi f'pazjenti b'limfoma jew majeloma multipla‚ ċelluli tat-tumur jistgħu jintreħew mill-mudullun u sussegwentement jinġabru fil-prodott tal-lewkaferesi.
English: In clinical studies, the dose of plerixafor has been calculated based on body weight in patients up to 175% of ideal body weight.
Maltese: Fi studji kliniċi, id-doża ta' plerixafor kienet ikkalkulata bbażata fuq il-piż talġisem f'pazjenti li kellhom sa 175% tal-piż ideali tal-ġisem.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Maltese: Deskrizzjoni ta' reazzjonijiet avversi partikulari
English: Proportion a in Mozobil and G-CSF (n=147
Maltese: Proporzjona f'Mozobil u G-CSF
English: cells/kg by apheresis day in multiple myeloma patients
Maltese: 6.3 Żmien kemm idum tajjeb il-prodott mediċinali Kunjett mhux miftuħ
English: There is insufficient clinical experience to make alternative posology recommendations for patients with a creatinine clearance <20 ml/min, as well as to make posology recommendations for patients on haemodialysis.
Maltese: Hemm esperjenza klinika insuffiċjenti biex isiru rakkomandazzjonijiet dwar pożoloġija alternattiva għal pazjenti bi tneħħija tal-krejatinina ta' < 20 ml/min, kif ukoll biex isiru rakkomandazzjonijiet dwar pożoloġija għal pazjenti fuq l-emodijalisi.
English: Administration of Mozobil in conjunction with G-CSF increases circulating leukocytes as well as haematopoietic stem cell populations.
Maltese: G-CSF ser jgħin lil Mozobil biex jaħdem kif suppost ġo ġismek.
English: Mozobil has been uncommonly associated with potential systemic reactions related to subcutaneous injection such as urticaria, periorbital swelling, dyspnoea, or hypoxia (see section 4.8).
Maltese: Mozobil kien assoċjat b'mod mhux komuni mal-possibbiltà ta' reazzjonijiet sistemiċi marbuta ma' injezzjoni minn taħt il-ġilda bħal urtikarja, nefħa periorbitali, qtugħ ta' nifs, jew nuqqas ta' ossiġnu (ara sezzjoni 4.8).
English: Further information on Veyvondi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Veyvondi contains the active substance vonicog alfa.
Maltese: Veyvondi fih is-sustanza attiva vonicog alfa.
English: The most common side effects with Veyvondi (which may affect up to 1 in 10 patients) are dizziness, vertigo (a spinning sensation), dysgeusia (taste disturbances), tremor, rapid heartbeat, deep venous thrombosis (blood clot in a deep vein, usually in the leg), hypertension (high blood pressure), hot flush, vomiting, nausea (feeling sick), pruritus (itching), chest discomfort, sensations like numbness, tingling, pins and needles at the site of infusion, and an abnormal reading on the electrocardiogram (ECG).
Maltese: L-effetti sekondarji l-aktar komuni b'Veyvondi (li jistgħu jaffettwaw sa pazjent 1 minn kull 10) huma sturdament, vertiġini (sensazzjoni ta' tidwir), diżgewżja (disturbi tat-togħma), rogħda, taħbit tal-qalb mgħaġġel, trombożi venuża profonda (koagulazzjoni f'vina fonda, normalment fir-riġel), ipertensjoni (pressjoni tad-demm għolja), fwawar, rimettar, nawżja (tħossok ma tiflaħx), pruritu (ħakk), skumdità fis-sider, sensazzjonijiet bħal tnemnim, tingiż, tarrix fissit tal-infużjoni, u qari anormali fuq l-elettrokardjogramma (ECG).
English: Other information about Veyvondi
Maltese: Informazzjoni oħra dwar Veyvondi
English: The second study involved 15 patients who were given Veyvondi to prevent bleeding during surgery, including major surgery such as knee replacement.
Maltese: It-tieni studju involva 15-il pazjent li ngħataw Veyvondi biex jipprevjeni fsada waqt kirurġija, inkluż kirurġija maġġuri bħal sostituzzjoni tal-irkoppa.
English: Treatment with Veyvondi was successful in 95% of patients (20 out of 22).
Maltese: Il-kura b'Veyvondi kienet ta' suċċess f'95 % tal-pazjenti (20 minn 22).
English: As for all medicines, data on the use of Veyvondi are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Veyvondi hija ssorveljata kontinwament.
English: A total of 193 bleeding episodes were recorded, and Veyvondi was rated ‘excellent' or ‘good' at treating around 98% of bleedings.
Maltese: Ġew irreġistrati total ta' 193 episodju ta' fsada, u Veyvondi tqies bħala “eċċellenti” jew “tajjeb” fil-kura ta' madwar 98 % ta' fsada.
English: The following side effects may occur during treatment with Veyvondi: hypersensitivity (allergic) reactions, thromboembolic events (problems due to the formation of blood clots in the blood vessels), development of inhibitors (antibodies) against von Willebrand factor, causing the medicine to stop working and resulting in a loss of bleeding control.
Maltese: L-effetti sekondarji li ġejjin jistgħu jseħħu waqt kura b'Veyvondi: reazzjonijiet ta' ipersensittività (allerġiċi), avvenimenti tromboemboliċi (problemi minħabba l-formazzjoni ta' emboli tad-demm filvażi), żvilupp ta' inibituri (antikorpi) kontra l-fattur von Willebrand, li jikkawża l-mediċina tieqaf taħdem u jirriżulta f'telf ta' kontroll tal-fsada.
English: What are the risks associated with Veyvondi?
Maltese: X'inhuma r-riskji assoċjati ma' Veyvondi?
English: The active substance in Veyvondi, vonicog alfa, works in the body in the same way as natural von Willebrand factor.
Maltese: Is-sustanza attiva f'Veyvondi, vonicog alfa, taħdem fil-ġisem bl-istess mod ta' kif jaħdem il-fattur von Willebrand naturali.
English: The benefits of Veyvondi in controlling bleeding have been shown in two main studies involving 52 patients with von Willebrand disease.
Maltese: Il-benefiċċji ta' Veyvondi fil-kontroll tal-fsada ntwerew f'żewġ studji ewlenin li involvew 52 pazjent bilmarda ta' von Willebrand.
English: Veyvondi was shown to be effective in treating bleeding episodes in patients with von Willebrand disease.
Maltese: Veyvondi ntwera li huwa effettiv biex jikkura episodji ta' fsada f'pazjenti bil-marda ta' von Willebrand.
English: Veyvondi was also effective for preventing and treating bleeding related to surgery.
Maltese: Veyvondi kien effettiv ukoll fil-prevenzjoni u fil-kura ta' fsada relatata ma' kirurġija.
English: How is Veyvondi used?
Maltese: Veyvondi?
English: Patients with von Willebrand disease lack von Willebrand factor, a protein needed for normal clotting of the blood, and as a result, they bleed readily.
Maltese: Pazjenti bil-marda ta' von Willebrand għandhom nuqqas ta' fattur von Willebrand, proteina meħtieġa għall-koagulazzjoni normali tad-demm, u bħala riżultat, ikollhom fsada faċilment.
English: In the 15 major and minor surgeries that occurred during the study, Veyvondi was rated as excellent or good at preventing bleeding episodes for all 15 surgeries.
Maltese: Fil-15-il kirurġija maġġuri u minuri li seħħew waqt listudju, Veyvondi ġie kklassifikat bħala eċċellenti jew tajjeb biex jipprevjeni episodji ta' fsada għall-15il kirurġija kollha.
English: For the full list of side effects of Veyvondi, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji ta' Veyvondi, ara l-fuljett ta' tagħrif.
English: The first study involved 37 patients who were given Veyvondi for the treatment of bleeding episodes.
Maltese: L-ewwel studju involva 37 pazjent li ngħataw Veyvondi għall-kura ta' episodji ta' fsada.
English: Veyvondi is available as a powder and solvent that are mixed together to make a solution for injection into a vein.
Maltese: Veyvondi jiġi bħala trab u solvent li jitħalltu flimkien biex jagħmlu soluzzjoni għall-injezzjoni ġo vina.
English: Veyvondi is a medicine used to control bleeding in patients with von Willebrand disease (an inherited bleeding disorder), who cannot be treated with another medicine called desmopressin or when desmopressin is ineffective.
Maltese: Veyvondi huwa mediċina li tintuża biex tikkontrolla fsada f'pazjenti bil-marda ta' von Willebrand (disturb tal-fsada li jintiret), li ma jistgħux jiġu kkurati b'mediċina oħra msejħa desmopressin jew meta desmopressin ma jkunx effettiv.
English: Rash (including dermatitis)
Maltese: Raxx (inkluż dermatite)
English: 30 Minutes
Maltese: 30 Minuta
English: Date of first authorisation: 21 May 2007 Date of latest renewal: 21 May 2012
Maltese: Data tal-ewwel awtorizzazzjoni: 21 ta' Mejju 2007 Data tal-aħħar tiġdid: 21 ta' Mejju 2012
English: The active substance is abatacept.
Maltese: Is-sustanza attiva hija abatacept.
English: Estimate of difference (95% CI)
Maltese: Stima ta' differenza (95% CI)
English: Study SC-II: abatacept versus adalimumab
Maltese: Studju SC-II: abatacept kontra adalimumab
English: Blue Indicator
Maltese: Indikatur Blu
English: leflunomide, azathioprine, gold, and anakinra.
Maltese: leflunomide, azathioprine, deheb, u anakinra.
English: Activation Button (BLUE)
Maltese: Buttuna ta' Attivazzjoni (BLU)
English: Bristol-Myers Squibb Co. 38 Jackson Road Devens, MA 01434 USA
Maltese: Bristol-Myers Squibb Co. 38 Jackson Road Devens, MA 01434
English: Month 12 43%‡
Maltese: Xahar 12 43%‡
English: Period Cb (day 1765)
Maltese: Perjodu Ċb (jum 1765)
English: Month 12 57%‡
Maltese: Xahar 12 57%‡
English: Doctor's Phone: ____________________
Maltese: Telefon tat-Tabib: ____________________
English: Uncommon Amenorrhea, menorrhagia
Maltese: Mhux komuni Amenorrea, menorraġija
English: b Concurrent DMARDs included one or more of the following: methotrexate, chloroquine/hydroxychloroquine, sulfasalazine,
Maltese: b DMARDs konkurrenti inkludew wieħed jew aktar milli ġej: methotrexate, chloroquine/hydroxychloroquine, sulfasalazine,
English: 1,000 mg a Approximating 10 mg/kg.
Maltese: 1,000 mg a Bejn wieħed u ieħor 10 mg/kg.
English: ACR30 65 ACR50 50 ACR70 28 ACR90 13 Inactive disease
Maltese: ACR70 28 ACR90 13 Marda inattiva
English: Structural response
Maltese: Rispons strutturali
English: Month 12 41%‡
Maltese: Xahar 12 41%‡
English: During Periods A, B, and C, acute infusion-related reactions occurred at a frequency of 4%, 2%, and 4%, respectively, and were consistent with the types of reactions reported in adults.
Maltese: Matul Perjodi A, B, u Ċ, reazzjonijiet akuti marbuta mal-infużjoni seħħew fi frekwenza ta' 4%, 2%, u 4%, rispettivament, u kienu konsistenti mat-tipi ta' reazzjonijiet irrappurtati fl-adulti.
English: Inactive disease*
Maltese: Marda inattiva*
English: a DAS28-defined remission (DAS28-CRP <2.6) b SDAI criterion (SDAI ≤ 3.3)
Maltese: a Remissjoni definita minn DAS28 (DAS28-CRP < 2.6) b Kriterju ta' SDAI (SDAI ≤ 3.3)
English: ACR 20 47.5%* 19.0% 28.7 (9.4, 48.0) ACR 50 25.0% 2.4% 22.7 (8.6, 36.9) ACR 70 12.5% 0% 12.5 (2.3, 22.7)
Maltese: 5%* 19.0% 28.7 (9.4, 48.0) ACR 50 25.0% 2.4% 22.7 (8.6, 36.9) ACR 70 12.5% 0% 12.5 (2.3, 22.7)
English: Placebo N=42
Maltese: Plaċebo N = 42
English: Study SC-I
Maltese: Studju SC-I
English: Month 6 Month 12 76%‡
Maltese: Xahar 12 76%‡
English: EXP XXXXX
Maltese: JIS XXXXX
English: Serious infections were reported in 0.8% (1/119), 3.4% (4/116) and 0% (0/116) patients.
Maltese: Infezzjonijiet serji kienu rrapportati fi 0.8% (1/119), 3.4% (4/116) u 0% (0/116) tal-pazjenti.
English: Study V: abatacept or infliximab versus placebo
Maltese: Studju V: abatacept jew infliximab kontra plaċebo
English: Note: It is normal to see a drop of fluid leaving the needle.
Maltese: Nota: Huwa normali li tara qatra ta' fluwidu ħierġa mil-labra.
English: Placebo N=211
Maltese: Plaċebo N = 211