FrancophonIA/ELRC3.0 huggingface dataset:
English: 95% confidence intervals for the differences in change scores between methotrexate and adalimumab c Based on rank analysis d
Maltese: 95% intervall ta' konfidenza ghad-differenza bejn il-punteġġi ta' methotrexate u adalimumab.
English: Expiration date
Maltese: Punt Finali
English: CARTON PRE-FILLED PEN
Maltese: Avvenimenti fil-fwied u fil-marrara
English: Week 12 results showed statistically significant improvement of the signs and symptoms of active non-radiographic axial spondyloarthritis in patients treated with adalimumab compared to placebo (table 9).
Maltese: Ir-riżultati ta' ġimgħa 12 wrew titjib statistikament sinifikanti tas-sinjali u ssintomi ta' axial spondyloarthritis attiva mhux radjografika f'pazjenti kkurati b'adalimumab meta mqabbla mal-plaċebo (tabella 9).
English: The European Medicines Agency has deferred the obligation to submit the results of the studies with adalimumab in one or more subsets of the paediatric population in ulcerative colitis and non-infectious uveitis, see section 4.2 for information on paediatric use.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddifferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'adalimumab f'wieħed jew iktar kategoriji tal-popolazzjoni pedjatrika b'kolite ulċerattiva u uveite mhux infettiva, ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku.
English: Of those in clinical response at week 4, 48% had been previously exposed to other TNF-antagonists.
Maltese: Minn dawk li kellhom rispons kliniku f'Ġimgħa 4, 48% kienu ġew esponuti għal kura oħra ta' antagonisti tat-TNF fil-passat.
English: The benefits and risks of continued weekly therapy should be carefully reconsidered in a patient with an inadequate response after the increase in dosing frequency (see section 5.1).
Maltese: Il-benefiċċji u r-riskji ta' terapija kontinwa ta' kull ġimgħa għandhom jiġu kkunsidrati mill-ġdid b'attenzjoni f'pazjent bi rispons mhux adegwat wara ż-żieda fil-frekwenza tad-dożaġġ (ara sezzjoni 5.1).
English: The needle cover of the pre-filled syringe is made from dry natural rubber (a derivative of latex) (see section 4.4).
Maltese: L-għatu tal-labra tal-pinna mimlija għal-lest huwa magħmul minn lastku naturali niexef (derivattiv tal-latex) (ara sezzjoni 4.4).
English: In RA studies I-IV, all individual components of the ACR response criteria (number of tender and swollen joints, physician and patient assessment of disease activity and pain, disability index (HAQ) scores and CRP (mg/dL) values) improved at 24 or 26 weeks compared to placebo.
Maltese: Fl-Istudji RA minn I-IV, il-komponenti kollha tal-kriterji tar-rispons għall-ACR (numru ta' ġogi bl-uġigħ u minfuħa, l-istima tal-attività tal-mard u tal-uġigħ magħmula mit-tabib u mill-pazjent, il-punti tal-indiċi ta' diżabilità (HAQ) u valuri tas-CRP (mg/dl)) marru għall-aħjar fir-24 u fis-26 ġimgħa meta pparagunati mal-plaċebo.
English: a HR of adalimumab versus placebo from proportional hazards regression with treatment as factor.
Maltese: HR ta' adalimumab vs plaċebo minn rigressjoni ta' perikli li huma proporzjonali mat-trattament bħala fattur.
English: Steroid-free remission for ≥ 90 days
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET RIGWARD ILPROVVISTA
English: Cough
Maltese: JEW
English: Adalimumab treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment as measured by change from baseline in mTSS (mean ± SD) 0.8 ± 2.5 in the placebo group (at week 24) compared with 0.0 ± 1.9; (p < 0.001) in the adalimumab group (at week 48).
Maltese: Il-kura b'adalimumab naqqset ir-rata li biha tipprogressa l-ħsara fil-ġogi periferali meta mqabbla malkura bil-plaċebo, kif imkejla mit-tibdil li kien hemm mil-linja bażi fil-punteġġ mTSS (medja ± SD) 0.8 ± 2.5 fil-grupp tal-plaċebo (f'Ġimgħa 24) meta mqabbel ma' 0.0 ± 1.9; (p < 0.001) fil-grupp ta' adalimumab (f'Ġimgħa 48).
English: Very common Leucopaenia (including neutropaenia and agranulocytosis), Anaemia
Maltese: Sensittività eċċessiva, Allerġiji (li jinkludu l-allerġija assoċjata mal-istaġuni)
English: The safety and efficacy of adalimumab were studied in adult patients with chronic plaque psoriasis (≥ 10% BSA involvement and Psoriasis Area and Severity Index (PASI) ≥ 12 or ≥ 10) who were candidates for systemic therapy or phototherapy in randomised, double-blind studies.
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab ġew studjati f'pazjenti adulti li jbatu minn Psorjasi kronika li tikkawża qoxra mhux normali fuq il-ġilda (≥ 10% involviment tal-BSA u l-Indiċi tal-Parti milquta millPsorjasi u s-Severità tagħha (PASI) ≥ 12 jew ≥ 10) li kienu kandidati għat-terapija sistemika jew għallfototerapija fi studji double-blind magħżula b'ordni addoċċ. 73% tal-pazjenti miktuba fl-Istudji talPsorjasi I u II kienu diġà irċevew terapija sistemika jew fototerapija.
English: No malignancies were observed in 249 paediatric patients with an exposure of 655.6 patient-years during adalimumab trials in patients with juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis).
Maltese: Ma ġewx osservati l-ebda tumuri malinni f'249 pazjenti pedjatriċi ta eta' bejn is sentejn u 17-il sena b'espożizzjoni ta' 655.6 sena ta' pazjent waqt provi b'adalimumab f'pazjenti b'artrite idjopatika taż-żagħżagħ (artrite idjopatika poliartikulari taż-żagħżagħ u artrite relatata mal-entesite).
English: Methotrexate should be continued during treatment with SOLYMBIC.
Maltese: Methotrexate għandu jitkompla waqt it-trattament b'SOLYMBIC.
English: SOLYMBIC is also used to treat severe plaque psoriasis in children and adolescents weighing either 23 to 28 kg or 47 kg or greater for whom topical therapy and phototherapies have either not worked very well or are not suitable.
Maltese: SOLYMBIC jintuża wkoll biex jittrata psorjasi tal-plakka severa fit-tfal u adolexxenti li jiżnu 23 sa 28 kg jew 47 kg jew aktar li għalihom terapija topika u fototerapiji jew ma ħadmux tajjeb ħafna jew mhumiex adattati.
English: paleness.
Maltese: SOLYMBIC.
English: PsA study I
Maltese: Studju RA I
English: In RA study III, where adalimumab-treated patients had a mean duration of rheumatoid arthritis of approximately 11 years, structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (TSS) and its components, the erosion score and joint space narrowing score.
Maltese: Fi Studju RA III, fejn pazjenti kkurati b'adalimumab kienu ilhom ibatu mill-artrite rewmatika għal medja ta' 11 -il sena, il-ħsara strutturali fil-ġogi kienet stimata radjografikament u ġiet espressa bħala bidla fil-Punteġġ Totali Sharp (TSS) u l-komponenti tiegħu, il-punteġġ relatat ma' erożjoni u tnaqqis fl-ispazju fil- ġogi.
English: With the needle cap off, insert the syringe into your skin at 45 to 90 degrees.
Maltese: Bl-għatu tal-labra mneħħi, daħħal is-siringa fil-ġilda b'angolu ta' 45 sa 90 grad.
English: Greater improvements at week 12 from baseline compared to placebo were demonstrated in skinspecific health-related quality of life, as measured by the Dermatology Life Quality Index (DLQI; Studies HS-I and HS-II), patient global satisfaction with medication treatment as measured by the Treatment Satisfaction Questionnaire-medication (TSQM; Studies HS-I and HS-II), and physical health as measured by the physical component summary score of the SF-36 (study HS-I).
Maltese: Studji HS-I u HS-II), u s-saħħa fiżika kif imkejla minn l-għadd sommarju ta' komponent fiżiku tal-SF-36 (Studju HS-I).
English: SOLYMBIC is only available as 20 mg and 40 mg pre-filled syringe and 40 mg pre-filled pen.
Maltese: Ir-reġim tad-doża tas-soltu huwa 80 mg fil-bidu segwit minn 40 mg ġimagħtejn wara.
English: Patients taking TNF-antagonists are more susceptible to serious infections.
Maltese: antagonisti ta' TNF oħra.
English: PsA study I with 24 week duration, treated 313 adult patients who had an inadequate response to non-steroidal anti-inflammatory drug therapy and of these, approximately 50% were taking methotrexate.
Maltese: Studju PsA I li dam 24 ġimgħa, tratta 313 pazjent adult li kellhom rispons mhux adegwat għall-kura b'mediċina anti-infjammatorja mhux sterojdi, u minn dawn, bejn wieħed u ieħor 50% kienu qegħdin jieħdu methotrexate.
English: Some subjects who experience insufficient response may benefit from an increase in dosing frequency to 20 mg SOLYMBIC every week.
Maltese: Xi pazjenti li jesperjenzaw tnaqqis fir-rispons tagħhom jistgħu jibbenifikaw minn żieda fil-frekwenza tad-doża għal 20 mg SOLYMBIC kull ġimgħa.
English: The observed rate of nonmelanoma skin cancers is approximately 9.6 per 1,000 patient-years, and the observed rate of lymphomas is approximately 1.3 per 1,000 patient-years.
Maltese: Ir-rata osservata ta' kanċer tal-ġilda li m'humiex melanoma hija ta' bejn wieħed u ieħor 9.6 kull 1,000 sena ta' pazjent, u r-rata osservata ta' limfomi hija ta' bejn wieħed u ieħor 1.3 kull 1,000 sena ta' pazjent.
English: Re-introduction of SOLYMBIC after discontinuation for 70 days or longer should result in the same magnitudes of clinical response and similar safety profile as before dose interruption.
Maltese: Jekk terġa' tingħata SOLYMBIC wara li tkun twaqqfet għal 70 gurnata jew aktar għandha twassal għall-istess rispons kliniku u profil ta' sigurta' li jixbaħ lil dak ta' qabel ma twaqqfet id-doża.
English: • sicca syndrome (including dry eyes and dry mouth);
Maltese: • vaskulite tal-ġilda (infjammazzjoni tal-vini tal-ġilda);
English: Concomitant administration of SOLYMBIC with other biologic DMARDS (e.g. anakinra and abatacept) or other TNF-antagonists is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions (see section
Maltese: L-għoti flimkien ta' SOLYMBIC ma' DMARDS bijoloġiċi oħra (e.ż. anakinra u abatacept) jew antagonisti ta' TNF oħra, mhux rakkomandat fuq bażi ta' żieda possibli fir-riskju ta' infezzjonijiet, inkluż infezzjonijiet serji u interazzjonijiet oħra ta' potenzjal farmakoloġiku.
English: Adalimumab 40 mg every other week was assessed in 393 patients in two randomised, 24 week double-blind, placebo-controlled studies in patients with active ankylosing spondylitis (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.3 in all groups) who have had an inadequate response to conventional therapy.
Maltese: It-teħid ta' 40 mg adalimumab ġimgħa iva u ġimgħa le kien stimat fi 393 pazjent f'żewġ studji doubleblind, kontrollati bil-plaċebo li ħadu 24 ġimgħa u li saru b'ordni addoċċ fuq pazjenti li jbatu minn infjammazzjoni tal-vertebri li jirriżulta fil-vertebri jitwaħħlu flimkien (ankylosing spondylitis) (il-punt medju tal-linja bażi tal-attività tal-mard [l-Indiċi tal-Attività tal-Mard Ankylosing Spondylitis (BASDAI)] kien 6.3 fil-gruppi kollha) li ma kellhomx rispons adegwata għat-terapija konvenzjonali.
English: Week 26 Placebo-controlled
Maltese: Ikkontrollat bi Plaċebo
English: Psoriatic arthritis is an inflammation of the joints associated with psoriasis.
Maltese: L-artrite psorjatika hija infjammazzjoni tal-ġogi assoċjata mal-psorjasi.
English: • neurological infections (including viral meningitis);
Maltese: • infezzjonijiet newroloġiċi (li jinkludu meninġite virali)
English: Evra norelgestromin / ethinylestradiol
Maltese: Evra norelgestromin / etinilestradiol
English: The full EPAR for Evra 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: This gives Evra a ‘Pearl Index' of 0.90.
Maltese: Dan jagħti lil Evra ‘Indiċi tal-Perla' ta' 0.90.
English: Other information about Evra
Maltese: Informazzjoni oħra dwar Evra
English: The Pearl Indices for the oral contraceptives were 0.57 (monophasic) and 1.28 (triphasic).
Maltese: L-Indiċi tal-Perla għall-kontrċettivi orali kienu 0.57 (monofastiċi) u 1.28 (trifasiċi).
English: Evra has been shown to be an effective contraceptive.
Maltese: Intwera li Evra kien kontraċettiv effettiv.
English: Evra is a transdermal patch version of ‘the pill' (combined oral contraceptive tablet).
Maltese: Evra hija verżjoni tal-garża transdermali tal-‘pill' (pillola kontraċettiva orali kkombinata).
English: It contains two active substances: norelgestromin (6 mg) and ethinylestradiol (600 micrograms).
Maltese: Evra fiha żewġ sustanzi attivi: norelgestromin (6 mg) u etinilestradiol (600 mikrogrammi).
English: This is a summary of the European public assessment report (EPAR) for Evra.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Evra.
English: Its safety and effectiveness have been studied in women aged 18 to 45 years.
Maltese: Is-sigurtà u l-effikaċja ta' Evra ġew studjata f'nisa ta' bejn it-18 u l-45 sena.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Evra on 22 August 2002.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Evra fit-22 ta' Awwissu 2002.
English: Why is Evra approved?
Maltese: Għaliex ġie approvat Evra?
English: The Pearl Index is a standard way of measuring the effectiveness of contraceptives, which measures how many unwanted pregnancies occur in 100 woman-years (corresponding to 1,300 cycles), with lower values indicating more effective contraception.
Maltese: L-Indiċi tal-Perla huwa mod standard ta' kif tkejjel l-effikaċja tal-kontraċettivi, li jkejjel l-okkorrenza ta' tqaliet mhux mixtieqa f'100 mara-sena (li jikkorrispondu għal 1,300 ċiklu mestrwali), b'valuri iktar baxxi li jindikaw kontraċezzjoni iktar effettiva.
English: It must also not be used together with certain antiviral medicines containing the active substances ombitasvir, paritaprevir, ritonavir and dasabuvir.
Maltese: Lanqas ma għandu jintuża flimkien ma' ċerti mediċini antivirali li fihom s-sustanzi attivi ombitasvir, paritaprevir, ritonavir u dasabuvir.
English: The active substances in Evra are two hormones, ethinylestradiol (an oestrogen) and norelgestromin (a progestogen).
Maltese: Is-sustanzi attivi f'Evra huma żewġ ormoni, l-etinilestradiol (oestroġenu) u norelgestromin (proġestogen).
English: Five of the pregnancies were in women weighing over 90 kg.
Maltese: Ħamsa mit-tqaliet kienu f'nisa li jiżnu iktar minn 90 kg.
English: What are the risks associated with Evra?
Maltese: X'inhuma r-riskji assoċjati ma' Evra?
English: It was studied in three main studies in over 3,000 women, which determined the number of women who became pregnant while taking the medicine.
Maltese: Evra ġie studjat fi tliet studji ewlenin f'iktar minn 3,000 mara, li ddetermina n-numru ta' nisa li ħarġu tqal waqt li kienu qed jieħdu l-mediċina.
English: Evra is a transdermal patch (a patch that delivers a medicine across the skin).
Maltese: Evra huwa garża transdermika (garża (patch) li tagħti l-mediċina minn ġol-ġilda).
English: Evra must not be used when a woman has, or has had blood clots in the veins or arteries including a stroke or a heart attack or when a woman has risk factors for blood clots (such as severe high blood pressure, diabetes with damage to the blood vessels, high cholesterol levels, or a family history of thrombosis).
Maltese: Evra ma għandux jintuża meta mara jkollha, jew kellha emboli tad-demm fil-vażi jew l-arterji inklużi attakki ta' puplesija jew attakk tal-qalb jew meta mara jkollha fatturi ta' riskju għall-emboli tad-demm (bħal pressjoni tad-demm għolja ħafna, diabete bi ħsara għall-vażi tad-demm, livelli ta' kolesterol għolja, jew passat fil-familja ta' trombożi).
English: In two studies, Evra was compared with combined oral contraceptives: in one study, the comparator was a ‘monophasic' contraceptive (pill containing the same amounts of active substances over the first three weeks of the treatment cycle) and in the other study, they were ‘triphasic' (with the amount of the active substances in the pills varying through the treatment cycle).
Maltese: F'żewġ studji, Evra tqabbel ma' kontraċettivi orali kkombinati: fi studju minnhom, il-komparatur kien kontraċettiv ‘monofasiku' (pill li fiha l-istess ammonti tas-sustanzi attivi matul l-ewwel tliet ġimgħat taċ-ċiklu talkura) u fl-istudju l-ieħor, kieku ‘trifasiku' (bl-ammont ta' sustanzi attivi fil-pills li jvarjaw permezz taċċiklu ta' kura).
English: Evra is a contraceptive used to prevent pregnancy.
Maltese: Evra huwa kontraċettiv użat biex jipprevjeni t-tqala.
English: Overall in the three studies, 15 pregnancies occurred in women taking Evra, 12 of which were the result of a ‘method failure' (when a pregnancy occurs despite the contraceptive being used correctly).
Maltese: B'kollox fit-tliet studji, kien hemm 15-il tqala f'nisa li kienu qed jieħdu Evra, 12 minnhom kienu riżultat ta' ‘falliment tal-metodu' (meta jkun hemm tqala minkejja li l-kontraċettiv jintuża kif suppost).
English: The medicine can only be obtained with a prescription.
Maltese: It-tielet studju ma qabbilx Evra ma' mediċini oħra.
English: Evra may work less well in women weighing 90 kg or more.
Maltese: Evra jista' jaħdem inqas tajjeb f'nisa li jiżnu 90 kg jew iktar.
English: It must not be used in women who have migraine with aura (unusual visual or other sensory experiences), severe liver problems, liver tumours or a history of liver tumours, some types of cancer or abnormal bleeding from the genital area whose cause has not been diagnosed.
Maltese: Ma għandux jintuża f'nisa li jbatu bl-emigranja bl-awra (esperjenzi viżwali mhux tas-soltu jew sensorjali), problemi serji fil-fwied, tumuri fil-fwied jew passat b'tumuri fil-fwied, ċerti tipi ta' kanċer, jew fsada anormali mill-parti ġenitali li l-kawża tagħha ma ġietx dijanjostikata.
English: Ethinylestradiol has been in use extensively in oral contraceptives for many years, and norelgestromin is very similar to another progestogen, which is also used in some oral contraceptives.
Maltese: L-etinilestradiol ilu jintuża b'mod estensiv bħala kontraċezzjoni orali għal ħafna snin, u norelgestromin huwa simili ħafna għall-progestogen ieħor, li jintuża wkoll f'xi kontraċettivi orali.
English: The patch-free interval must not be longer than seven days; otherwise, additional nonhormonal contraceptive methods must be used, such as condoms.
Maltese: L-intervall mingħajr garża ma għandux ikun itwal minn sebat ijiem; inkella, jridu jintużaw metodi kontraċettivi mhux ormonali addizzjonali bħall-kondoms.
English: How is Evra used?
Maltese: Kif jaħdem Evra?
English: The company that markets Evra will perform a study to further investigate the risk of blood clots.
Maltese: Il-kumpanija li tqiegħed Evra fis-suq ser tkompli tistudja biex tinvestiga iktar ir-riskju tal-emboli taddemm.
English: The most common side effects with Evra (seen in more than 1 patient in 10) were headache, nausea (feeling sick) and breast tenderness.
Maltese: L-effetti sekondarji l-aktar komuni b'Evra (li dehru f'aktar minn pazjent 1 minn 10) huma wġigħ ta' ras, nawżja (dardir) u rtubija tas-sider.
English: 50 ml (20 mg/ml) 1 vial l t o r
Maltese: 50 ml (20 mg/ml) 1 vial
English: 196 (2 x 98) tablets l t o r
Maltese: 196 (2 x 98) pillola t x
English: Further information on the orphan designation can be found on here: ema.europa.eu/medicines/human/orphan-designations/eu304227.
Maltese: ema.europa.eu/medicines/human/orphan-designations/eu304227.
English: Further information on Mozobil can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/mozobil.
Maltese: ema.europa.eu/en/medicines/human/EPAR/mozobil.
English: Mozobil contains the active substance plerixafor.
Maltese: Mozobil fih is-sustanza attiva plerixafor.
English: Other information about Mozobil
Maltese: Informazzjoni oħra dwar Mozobil
English: • adults with lymphoma or multiple myeloma (types of blood cancer);
Maltese: • adulti b'linfoma jew majeloma multipla (tipi ta' kanċer fid-demm);
English: The active substance in Mozobil, plerixafor, works by blocking the activity of a protein called the ‘CXCR4 chemokine receptor'.
Maltese: Is-sustanza attiva f'Mozobil, il-plerixafor, taħdem billi timblokka l-attività ta' proteina li tissejjaħ ir-”riċettur tal-kimokina CXCR4”.
English: Mozobil is used together with G-CSF.
Maltese: Mozobil jintuża flimkien mal-G-CSF.
English: Among the adults with multiple myeloma, 72% (106 out of 148) of those receiving Mozobil achieved the target number of stem cells within 4 collection days, compared with 34% (53 out of 154) of the patients receiving placebo.
Maltese: Fost l-adulti b'mijeloma multipla, 72 % (106 minn 148) ta' dawk li rċevew Mozobil kisbu n-numru fil-mira ta' ċelloli staminali fi żmien erbat ijiem ta' ġbir, meta mqabbla ma' 34 % (53 minn 154) tal-pazjenti li ngħataw il-plaċebo.
English: Among the adults with lymphoma, 59% (89 out of 150) of those receiving Mozobil achieved the target number of stem cells within 4 collection days, compared with 20% (29 out of 148) of the patients receiving placebo.
Maltese: Fost l-adulti bil-linfoma, 59 % (89 minn 150) ta' dawk li rċevew Mozobil kisbu n-numru fil-mira ta' ċelloli staminali fi żmien erbat ijiem tal-ġbir, meta mqabbla ma' 20 % (29 minn 148) tal-pazjenti li ngħataw il-plaċebo.
English: In two main studies involving 298 adults with non-Hodgkin's lymphoma and 302 adults with multiple myeloma, more patients who received Mozobil achieved the target number of stem cells and had successful engraftment of stem cells (the cells started growing and producing normal blood cells after transplantation) than patients who received placebo (a dummy treatment).
Maltese: F'żewġ studji ewlenin, li involvew 298 adult li jbatu bil-linfoma ta Hodgkin u 302 adulti li jbatu minn mijeloma multipla, aktar pazjenti li rċivew Mozobil kisbu n-numru fil-mira ta' ċelloli staminali u kellhom tilqim b'suċċess taċ-ċelloli staminali (iċ-ċelloli bdew jikbru u jipproduċu ċelloli tad-demm normali wara t-trapjant) meta mqabbla mal-pazjenti li rċivew il-plaċebo (kura finta).
English: In a main study involving 45 children with lymphoma or solid tumours, 80% (24 out of 30) of patients who received Mozobil had at least a doubling of the number of stem cells in the blood, compared with 29% (4 out of 14) patients who received standard mobilisation treatment alone.
Maltese: Fi studju ewlieni li involva 45 tifel u tifla b'linfoma jew tumuri solidi, 80 % (24 minn 30) tal-pazjenti li rċevew Mozobil kellhom mill-inqas id-doppju tan-numru ta' ċelloli staminali fid-demm, meta mqabbla ma' 29 % (4 minn 14) tal-pazjenti li rċevew trattament ta' mobilizzazzjoni standard biss.
English: G-CSF is used on its own for 4 days before Mozobil is added.
Maltese: G-CSF jintuża waħdu erbat ijiem qabel jiżdied Mozobil.
English: What are the risks associated with Mozobil?
Maltese: X'inhuma r-riskji assoċjati ma' Mozobil?
English: • children from 1 year of age who have lymphoma or solid tumours.
Maltese: • tfal li għandhom sena jew aktar li għandhom linfoma jew tumuri solidi.
English: The number of patients that need mobilisation and collection of haematopoietic stem cells for transplantation is low and Mozobil was designated an ‘orphan medicine' (a medicine used in rare diseases) on 20 October 2004.
Maltese: In-numru ta' pazjenti li jeħtieġu l-mobilizzazzjoni u l-ġbir ta' ċelloli staminali ematopojetiċi għal trapjant huwa baxx u Mozobil ġie kklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fl20 ta' Ottubru 2004.
English: Mozobil received a marketing authorisation valid throughout the EU on 31 July 2009.
Maltese: Mozobil ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fil-31 ta' Lulju 2009.
English: The most common side effects with Mozobil (which may affect more than 1 patient in 10) are diarrhoea, nausea (feeling sick) and reactions at the site of injection.
Maltese: L-effetti sekondarji l-aktar komuni b'Mozobil (li jistgħu jaffettwaw aktar minn pazjent 1 minn kull 10) huma dijarea, nawżja (tħossok ma tiflaħx) u reazzjonijiet fis-sit tal-injezzjoni.