FrancophonIA/ELRC3.0 huggingface dataset:
English: Skin and hair changes Skin thickening, moles and abnormal hair texture have been seen with mecasermin treatment.
Maltese: Bidliet fil-gilda u fix-xagħar Ħxuna tal-ġilda, moles, u x-xagħar jinħass mhux normali dehru bi trattament b'mecasermin
English: Doses greater than 0.12 mg/kg given twice daily have not been evaluated in children with severe Primary IGFD.
Maltese: 12 mg/kg mgħotija darbtejn kuljum ma ġewx evalwati fi tfal b'IGFD primarja severa.
English: Annual results for height velocity, height velocity SDS, and height SDS until year 8 are shown in Table 2.
Maltese: Riżultati annwali għal veloċità tat-tul, SDS tal-veloċità tat-tul u SDS tat-tul sat-8 sena jidhru fitTabella 2.
English: In post-marketing experience in patients treated with INCRELEX, cases of hypersensitivity, urticaria, pruritus and erythema have been reported.
Maltese: Wara l-kummerċjalizzazzjoni, fil-pazjenti ttrattati bl-INCRELEX, ġew irrapportati każijiet ta' ipersensitività, urtikarja, ħakk u eritema.
English: It is important that you have a well-balanced diet including protein and fat such as meat and cheese in addition to sugarcontaining foods.
Maltese: Huwa importanti li inti jkollok dieta bilanċjata tajjeb li tinkludi proteini u grass bħal laħam u ġobon flimkien ma' ikel li fih iz-zokkor.
English: The absolute subcutaneous bioavailability of mecasermin in severe Primary IGFD subjects has not been determined.
Maltese: Il-bijodisponibiltà assoluta ta' mecasermin mogħti taħt il-ġilda f'suġġetti b'IGFD primarja severa ma ġietx determinata.
English: The safety and efficacy of mecasermin in children below age of 2 have not been established (see section 5.1).
Maltese: Is-sigurtà u l-effikaċja ta' mecasermin fit-tfal ta' età taħt is-2 ma ġewx determinati s'issa (ara sezzjoni 5.1).
English: Mecasermin may cause hypoglycaemia (very common side effect, see section 4) that may impair your ability to drive and use machines because your ability to concentrate or react may be reduced.
Maltese: Mecasermin jista' jikkawża ipogliċemija (effett sekondarju komuni ħafna, ara sezzjoni 4) li tista' xxekkel l-abilità tiegħek li ssuq jew tuża maġni għaliex tista' tonqos l-abilità tiegħek li tikkonċentra jew tirreaġġixxi.
English: The height velocities for years 2 through 8 remained statistically greater than baseline.
Maltese: Il-veloċitajiet tat-tul għas-snin 2 sa 8 baqgħu statistikament akbar mil-linja bażi.
English: At the time of initial prescription, physicians should educate parents on the signs, symptoms and treatment of hypoglycaemia, including injection of glucagon.
Maltese: Waqt iż-żmien li tingħata l-ewwel riċetta, it-tobba għandhom jgħallmu lill-ġenituri s-sinjali, sintomi u trattament ta' ipogliċemija, inkluża l-injezzjoni ta' glukagon.
English: If it is present, your doctor may decide to temporarily reduce or discontinue mecasermin therapy.
Maltese: Jekk preżenti, it-tabib tiegħek jista' jiddeċiedi li temporanjament inaqqas jew iwaqqaf it-terapija b'mecasermin.
English: Do not use this medicine after the expiry date which is stated on the carton and label after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u t-tikketta wara
English: Figure B: Press (don't rub) with gauze or cotton
Maltese: Figura B: Agħfas (togħrokx) b'garża jew tajjara
English: If you take INCRELEX, you should avoid participating in high risk activities (such as vigorous physical activity) within 2 to 3 hours after INCRELEX injection, especially at the beginning of INCRELEX treatment.
Maltese: Jekk tieħu INCRELEX, għandek tevita li tipparteċipa f'attivitajiet ta' riskju għoli (bħal attività fiżika vigoruża) fi żmien 2 sa 3 sigħat wara l-injezzjoni ta' INCRELEX, speċjalment fil-bidu ta' trattament b'INCRELEX.
English: The most frequently occurring side effects with mecasermin are: low blood sugar (hypoglycemia), vomiting, injection site reactions, headache and middle ear infections.
Maltese: L-effetti sekondarji l-aktar komuni li jseħħu b'mecasermin huma: zokkor fid-demm baxx (ipogliċemija), rimettar, reazzjonijiet fis-sit tal-injezzjoni, uġigħ ta' ras u infezzjonijiet fil-parti tannofs tal-widna.
English: For the 21 treatment naïve subjects with near-adult height, the mean (± SD) of the difference between observed increase in height versus that expected from Laron was approximately 13 cm (± 8 cm) after an average of 11 years of treatment.
Maltese: Għall-21 individwu li qatt ma kienu ħadu l-kura qabel b'tul ta' kważi dak ta' adult, il-medja (± SD) tad-differenza bejn iż-żieda osservata fit-tul kontra dik mistenija minn Laron kienet madwar 13 ċm (± 8 ċm) wara medja ta' 11-il sena ta' kura.
English: Hypoacusis (hearing loss), ear pain and fluid in the middle ear have been observed with mecasermin treatment.
Maltese: Ipoakusi (telf ta' smigħ), uġigħ fil-widnejn u fluwidu fil-parti tan-nofs tal-widna ġew osservati b'kura b'mecasermin.
English: Mean (SD) -3.4 (1.6) 1.7
Maltese: IGF-1 (ng/ml): 24.5 
English: Blood and lymphatic system disorders
Maltese: Disturbi tad-demm u fis-sistema limfatika
English: The recommended starting dose of mecasermin is 0.04 mg/kg of body weight twice daily by subcutaneous injection.
Maltese: Id-doża tal-bidu ta' mecasermin rakkomandata hija ta' 0.04 mg/kg tal-piż tal-ġisem darbtejn kuljum taħt il-ġilda.
English: The MAH must ensure that, at launch, all physicians who are expected to prescribe INCRELEX are provided with a “physician information pack” containing the following:
Maltese: L-MAH għandu jiżgura li, mal-illanċjar, it-tobba kollha li mistennija jippreskrivu INCRELEX jiġu provduti b'"pakkett ta' informazzjoni għat-tabib" li fih dan li ġej:
English: EMEA/H/C/000109
Maltese: EMA/234576/2016 EMEA/H/C/000109
English: The full EPAR for Rilutek 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: Rilutek riluzole
Maltese: Rilużolu
English: It is available as 50 mg tablets.
Maltese: Jiġi bħala pilloli ta' 50mg.
English: Rilutek is used in patients with amyotrophic lateral sclerosis (ALS).
Maltese: Rilutek jintuża f'pazjenti li għandhom sklerosi amijotrofika laterali (ALS).
English: The active substance in Rilutek, riluzole, acts on the nervous system.
Maltese: Is-sustanza attiva f'Rilutek, ir-rilużolu, taġixxi fuq is-sistema nervuża.
English: This is a summary of the European public assessment report (EPAR) for Rilutek.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Rilutek.
English: Across the studies, Rilutek was given as 50, 100 or 200 mg per day, and for up to 18 months.
Maltese: Waqt l-istudju, Rilutek ingħata bħala 50, 100 jew 200 mg kuljum, u sa 18-il xahar.
English: Other information about Rilutek
Maltese: Informazzjoni oħra dwar Rilutek
English: Rilutek 50 mg/day was no more effective than placebo and 200 mg/day was no more effective than 100 mg/day.
Maltese: Rilutek 50 mg/kuljum ma kienx aktar effettiv mill-plaċebo u 200 mg/kuljum ma kienx aktar effettiv minn 100 mg/kuljum.
English: The most common side effects seen with Rilutek (in more than 1 patient in 10) are nausea (feeling sick), asthenia (weakness) and abnormal liver tests.
Maltese: L-effetti sekondarji l-aktar komuni li dehru b'Rilutek (f'aktar minn pazjent 1 f'10) huma dardir (tħossok ma tiflaħx), astenja (debolezza) u testijiet tal-fwied anormali.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rilutek on 10 June 1996.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Rilutek 10 ta' Ġunju 1996.
English: Rilutek has been compared with placebo (a dummy treatment) in three studies involving a total of 1,282 patients.
Maltese: Rilutek tqabbel ma'plaċebo (kura finta) fi tliet studji li kienu jinvolvu total ta' 1,282 pazjent.
English: Why has Rilutek been approved?
Maltese: Għaliex ġie approvat Rilutek?
English: ALS is a form of motor neuron disease where the nerve cells responsible for sending instructions to the muscles gradually deteriorate, leading to weakness, muscle wasting and paralysis.
Maltese: ALS hija forma ta' marda tannewroni motorili meta n-nervituri responsabbli biex jibagħtu messaġġi lill-muskoli jiddeterjoraw gradwalment, iwasslu għal dgħjufija, tpaħpiħ muskolari u paraliżi.
English: Rilutek is a medicine containing the active substance riluzole.
Maltese: Rilutek hija mediċina li fiha s-sustanza attiva rilużolu.
English: The recommended dose is 100 mg per day (given as one 50 mg tablet every 12 hours).
Maltese: Id doża rakkomandata hija ta' 100 mg kuljum (mogħtija bħala pinnola ta' 50 mg kull 12-il siegħa).
English: What is Rilutek?
Maltese: Kif jintuża Rilutek?
English: The CHMP decided that Rilutek's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Rilutek huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: For the full list of all side effects reported with Rilutek, see the package leaflet.
Maltese: Għal-lista sħiħa tal- effetti sekondarji rrapportati b'Rilutek, ara l-fuljett ta' tagħrif.
English: The medicine was not more effective than placebo in the late stages of ALS.
Maltese: Ilmediċina ma kinetx aktar effettiva mill-plaċebo fl-aħħar stadji ta' ALS.
English: • phaeochromocytoma (a tumour of the adrenal gland);
Maltese: • feokromoċitoma (tumur tal-glandola adrenali);
English: It is available as a range of tablets in seven strengths, containing 50 to 200 mg levodopa and 12.5 to 50 mg carbidopa.
Maltese: Jiġi f'diversi pilloli b'seba' qawwiet differenti, minn 50 sa 200 mg ta' levodopa u 12.5 sa 50mg ta' karbidopa.
English: The maximum daily dose of Levodopa/Carbidopa/Entacapone Orion is 10 tablets, except for the tablets containing 175 mg levodopa and 43.75 mg carbidopa, for which the maximum daily dose is eight tablets, and those containing 200 mg levodopa and 50 mg carbidopa, for which it is seven tablets.
Maltese: Id-doża massima ta' Levodopa/Carbidopa/Entacapone Orion hija 10 pilloli kuljum, għajr għall-pilloli li fihom 175 mg levodopa u 43,75 mg karbidopa, li għalihom id-doża massima hija tmien pilloli kuljum u dawk li fihom 200mg levodopa u 50 mg karbidopa li għalihom hija seba' pilloli kuljum.
English: The full EPAR for Levodopa/Carbidopa/Entacapone Orion 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: • a history of neuroleptic malignant syndrome (a dangerous nervous system disorder usually caused by antipsychotic medicines) or rhabdomyolysis (breakdown of muscle fibres).
Maltese: • storja ta' sindromu newrolettiku malinn (disturb nervuż perikoluż li s-soltu jkun ikkawżat minn mediċini antipsikotiċi) jew rabdomjoliżi (tkissir tal-fibri muskolari).
English: Entacapone has been authorised in the European Union (EU) as Comtess/Comtan since 1998.
Maltese: Lentakapone ilha awtorizzata fl-Unjoni Ewropea (UE) mill-1998 bħala Comtess/Comtan.
English: EPAR summary for the public levodopa/carbidopa/entacapone
Maltese: Sommarju tal-EPAR għall-pubbliku levodopa/carbidopa/entacapone
English: Levodopa/Carbidopa/Entacapone Orion is a medicine that contains three active substances: levodopa, carbidopa and entacapone.
Maltese: Levodopa/Carbidopa/Entacapone Orion huwa mediċina li fiha tliet sustanzi attivi: il-levodopa, ilkarbidopa u l-entakapone.
English: Levodopa/Carbidopa/Entacapone Orion must not be used together with other medicines that belong to the group ‘monoamine oxidase inhibitors' (a type of antidepressant).
Maltese: Levodopa/Carbidopa/Entacapone Orion ma għandux jintuża flimkien ma' mediċini oħrajn li jappartjenu lill-grupp tal-‘inibituri tal-monoaminoossidażi' (tip ta' antidepressiv).
English: This authorisation was based on the authorisation granted to Stalevo in 2003 (‘informed consent').
Maltese: Din l-awtorizzazzjoni kienet ibbażata fuq l-awtorizzazzjoni mogħtija lil Stalevo fl-2003 (‘kunsens infurmat').
English: This is a summary of the European public assessment report (EPAR) for Levodopa/Carbidopa/Entacapone Orion.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Levodopa/Carbidopa/Entacapone Orion.
English: The company carried out ‘bioequivalence' studies to show that taking Levodopa/Carbidopa/Entacapone Orion produces the same levels of levodopa, carbidopa and entecapone in the blood as taking separate tablets containing entacapone and the combination of levodopa and carbidopa.
Maltese: Il-kumpanija għamlet studji ta' ‘bijoekwivalenza‘ biex turi li t-teħid ta' f'Levodopa/Carbidopa/Entacapone Orion jipproduċi l-istess livelli tas-sustanzi attivi levodopa, karbidopa u entakapone fid-demm daqs it-teħid b'mod separat ta' pilloli li jkun fihom l-entakapone u kombinazzjoni tal-levodopa u l-karbidopa.
English: The most common side effects with Levodopa/Carbidopa/Entacapone Orion (seen in more than 1 patient in 10) are dyskinesia (uncontrollable movements), muscle pain, diarrhoea and nausea (feeling sick) and harmless urine discoloration.
Maltese: L-effetti sekondarji l-aktar komuni b'Levodopa/Carbidopa/Entacapone Orion (li feġġu f'iżjed minn pazjent wieħed minn kull 10) huma diskineżija (movimenti bla kontroll), uġigħ fil-muskoli, dijarrea u nawżja (dardir) u telf tal-kulur tal-urina li ma jagħmilx ħsara.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Levodopa/Carbidopa/Entacapone Orion on 24 August 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Levodopa/Carbidopa/Entacapone Orion fl-24 ta' Awwissu 2011.
English: • narrow-angle glaucoma (increased pressure within the eye);
Maltese: • glawkoma b'angolu dejjaq (żieda fil-pressjoni tal-għajnejn);
English: Serious side effects which have been reported much less often include gastrointestinal haemorrhage (bleeding in the gut) and angioedema (swelling under the skin of face or limbs).
Maltese: Effetti sekondarji serji li huma rrappurtati inqas spiss jinkludu emorraġija gastrointestinali (fsada fl-imsaren) and anġjoedema (nefħa taħt il-ġilda tal-wiċċ jew fid-dirgħajn u r-riġlejn).
English: Both carbidopa and entacapone block some of the enzymes that are involved in the breakdown of levodopa in the body: carbidopa blocks the enzyme dopa decarboxylase, and entacapone blocks the enzyme catechol-O-methyl transferase (COMT).
Maltese: Kemm il-karbidopa u kemm l-entakapone jimblukkaw l-enzimi li huma involuti fid-dekompożizzjoni tal-levodopa fil-ġisem: ckarbidopa timblokka l-enzima dopa dekarbossilażi filwaqt li entakapone timblokka l-enzima katekol-O-metil transferażi (catechol-Omethyl transferase, COMT).
English: All of the tablets contain 200 mg entacapone.
Maltese: Il-pilloli kollha fihom 200mg entakapone.
English: The studies showed that Levodopa/Carbidopa/Entacapone Orion is bioequivalent to the separate tablets.
Maltese: L-istudji wrew li Levodopa/Carbidopa/Entacapone Orion huwa bijoekwivalenti għall-pilloli separati.
English: What is Levodopa/Carbidopa/Entacapone Orion?
Maltese: X'inhu Levodopa/Carbidopa/Entacapone Orion?
English: Levodopa/Carbidopa/Entacapone Orion is used in patients who are being treated with a combination of levodopa and an inhibitor of dopa decarboxylase (two standard treatments for Parkinson's disease) but are having ‘fluctuations' towards the end of the period between two doses of their medication.
Maltese: Levodopa/Carbidopa/Entacapone Orion jintuża f'pazjenti li jkunu qed jiġu ttrattati b'taħlita tal-levodopa u tal-inibitur tad-dopa dekarbossilażi (żewġ trattamenti standard għall-kura tal-marda ta' Parkinson) u li jkollhom ‘varjazzjonijiet' lejn tmiem il-perjodu ta' bejn żewġ dożi tal-kura tagħhom.
English: Other information about Levodopa/Carbidopa/Entacapone Orion
Maltese: Aktar tagħrif dwar Levodopa/Carbidopa/Entacapone Orion
English: The company used some of the data from Comtess/Comtan to support the use of Levodopa/Carbidopa/Entacapone Orion and presented data from the published literature for levodopa and carbidopa.
Maltese: Il-kumpanija użat diversi siltiet mit-tagħrif dwar Comtess/Comtan biex tappoġġja l-użu ta' Levodopa/Carbidopa/Entacapone Orion u ppreżentat dejta mid-dokumentazzjoni li kienet ġiet ippubblikata dwar il-levodopa u l-karbidopa.
English: They should be used with caution in patients with mild to moderately reduced liver function or severely reduced kidney function.
Maltese: Dawn għandhom jittieħdu b'attenzjoni minn pazjenti li jbatu minn tnaqqis ħafif għal moderat fil-funzjoni talfwied jew tnaqqis gravi fil-funzjoni tal-kliewi.
English: Parkinson's disease is a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
Maltese: Il-marda ta' Parkinson hija disturb progressiv fil-moħħ li jikkawża rogħda, dewmien filmovimenti u ebusija fil-muskoli.
English: All of the active substances in Levodopa/Carbidopa/Entacapone Orion work to restore the levels of dopamine in the parts of the brain that control movement and co-ordination.
Maltese: Is-sustanzi attivi kollha f'Levodopa/Carbidopa/Entacapone Orion jaħdmu biex iġibu lura l-livelli tad-dopamina meħtieġa filpartijiet tal-moħħ li jikkontrollaw il-moviment u l-koordinazzjoni.
English: The CHMP decided that Levodopa/Carbidopa/Entacapone Orion's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Levodopa/Carbidopa/Entacapone Orion huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: What is the risk associated with Levodopa/Carbidopa/Entacapone Orion?
Maltese: X'inhu r-riskju assoċjat ma' Levodopa/Carbidopa/Entacapone Orion?
English: 3 pre-filled pens
Maltese: 3 pinen mimlijin għal-lest
English: 1 pre-filled pen
Maltese: Għamla farmaċewtika
English: Invented name Strength Pharmaceutical Form Route of administration
Maltese: Mnejn jingħata Il-pakkett
English: n/N^ [95% CI]
Maltese: [95% CI]
English: Common (≥1% - <10%)
Maltese: Komuni (≥1% - <10%)
English: Study Total number (adolescents)
Maltese: Studju Numru totali (adolexxenti)
English: België/Belgique/Belgien, България, Česká republika, Danmark, Eesti, Ελλάδα, España, Hrvatska, Ireland, Ísland, Κύπρος, Latvija,
Maltese: België/Belgique/Belgien, България, Česká republika, Danmark, Eesti, Ελλάδα, España, Hrvatska, Ireland, Ísland, Κύπρος, Latvija, Lietuva, Luxembourg/Luxemburg, Magyarország, Malta, Norge, Österreich, Polska, Portugal, România, Slovenija, Slovenská republika, Suomi/Finland, Sverige bluebird bio (Netherlands) B.V/.
English: See section 2, Sodium content.
Maltese: Ara sezzjoni 2, Kontenut tas-sodium.
English: • premature menopause
Maltese: • menopawsa prematura
English: Date of first authorisation: 29 May 2019
Maltese: Data tal-ewwel awtorizzazzjoni: 29 ta' Mejju 2019
English: Each dose contains 391-1564 mg sodium.
Maltese: Kull doża fiha 391-1564 mg ta' sodium.
English: o The importance of annual check-ups.
Maltese: o L-importanza ta' check-ups annwali.
English: WA Hb during TI (g/dL)
Maltese: WA Hb waqt TI (g/dL)
English: Protocol submission:
Maltese: Sottomissjoni tal-protokoll:
English: Splenomegaly, Leukocytosis
Maltese: Splenomegalija, Lewkoċitosi
English: apceth Biopharma GmbH Haidgraben 5
Maltese: Manifattur apceth Biopharma GmbH Haidgraben 5
English: • irregular menstruation
Maltese: • mestruwazzjoni irregolari
English: • decreased testosterone
Maltese: • tnaqqis fit-testosteron
English: Events were mild and included abdominal pain, hot flush, dyspnoea, and non-cardiac chest pain in 9.5%, 2.4%, 2.4%, and 2.4% of patients, respectively.
Maltese: L-avvenimenti kienu ħfief u inkludew uġigħ addominali, fwawar, dispnea, u wġigħ mhux kardijaku fis-sider f'9.5%, 2.4%, 2.4%,
English: Hb = Total Hb. WA Hb = Weighted average Hb.
Maltese: WA Hb = Medja ppiżata (weighted average) ta' Hb.
English: Also contains Cryostor CS5 and sodium chloride.
Maltese: Fih ukoll Cryostor CS5 u sodium chloride.
English: CD34+ Cells
Maltese: CD34+
English: Cardiac T2* at baseline was >20 msec.
Maltese: T2* Kardijaku fil-linja bażi kien >20 msec.
English: The median (min, max) busulfan dose was 3.50 (2.5, 5.0) mg/kg/day (N=32).
Maltese: Id-doża medjana (min, mass) ta' busulfan kienet 3.50 (2.5, 5.0) mg /kg/jum (N=32).
English: Five patients are evaluable for assessment of TI. Of these, 4/5 (80.0%, 95% CI 28.4-99.5%) achieved TI at last follow-up.
Maltese: Minn dawn, 4/5 (80.0%, 95% CI 28.4-99.5%) kisbu TI fl-aħħar segwitu.
English: Frozen: 1 year at ≤-140°C.
Maltese: Sena f'≤-140°C.
English: Duration of TI
Maltese: META TAGĦTI
English: Gastrointestinal disorders
Maltese: Infjammazzjoni gastrointestinali,
English: Hypoxia, Epistaxis
Maltese: Ipossija, Epistassi
English: Bars represent interquartile ranges.
Maltese: Bars jirrappreżentaw meded interkwartili.
English: n median (min, max)
Maltese: n medjan (min, mass)
English: Anti-retroviral and hydroxyurea use
Maltese: Użu antiretrovirali u ta' hydroxyurea
English: Bag ID:
Maltese: ID COI:
English: Once thawed: maximum 4 hours at room temperature (20°C-25°C).
Maltese: Ladarba jinħall: massimu ta' 4 sigħat f'temperatura ambjentali (20°C-25°C).
English: Patients seropositive for human immunodeficiency virus (HIV) or human T-lymphotropic virus (HTLV)
Maltese: Pazjenti seropożittivi għall-virus tal-immunodefiċjenza umana (HIV) jew għall-virus T‑limfotropiku uman (HTLV, human T‑lymphotropic virus)
English: Name (Last, First):
Maltese: Isem (Kunjom, Isem):
English: • increase in female hormones
Maltese: • żieda fl-ormoni femminili
English: Previous treatment with HSC gene therapy.
Maltese: Kura preċedenti bit-terapija tal-ġene HSC.
English: A total of 28.6% of patients (12/42; HGB-204, HGB-205, HGB-207, HGB-212) received G-CSF within 21 days after Zynteglo infusion.
Maltese: Total ta' 28.6% tal-pazjenti (12/42; HGB-204, HGB-205, HGB-207, HGB-212) irċivew G-CSF fi żmien 21 jum wara l-infużjoni ta' Zynteglo.
English: Final results: December 2021
Maltese: Diċembru 2021
English: • piles (haemorrhoids)
Maltese: • murliti (emorrojdi)
English: The most serious adverse reaction attributed to Zynteglo was thrombocytopenia (2.4%).
Maltese: Ir-reazzjoni avversa l-aktar serja attribwita lil Zynteglo kienet tromboċitopenija (2.4%).
English: Risk of insertional oncogenesis
Maltese: Riskju ta' onkoġeneżi inserzjali
English: An in vitro immortalisation (IVIM) assay conducted with BB305 LVV-transduced mouse bone marrow cells (BMCs) showed minimal mutagenic potential (Fitness Score ≈ 0.1 × 10-4).
Maltese: Assaġġ tal-immortalizzazzjoni in vitro (IVIM) imwettaq b'ċelluli tal-mudullun tal-ġrieden (BMCs) BB305 trasdotti b'LVV uriet potenzjal mutaġeniku minimu (Punteġġ ta' Idoneità ≈ 0.1 × 10)-4).
English: Zynteglo 1.2-20 × 106 cells/mL dispersion for infusion.
Maltese: Zynteglo 1.2-20 × 106 ċelluli/mL dispersjoni għall-infużjoni.
English: In HGB-207 and HGB-212 prophylaxis for VOD/hepatic sinusoidal obstruction syndrome was required per institutional practice with ursodeoxycholic acid or defibrotide.
Maltese: F'HGB-207 u HGB-212 kienet meħtieġa profilassi għall-VOD/sindrome ta' ostruzzjoni sinusojdali tal-fwied għal kull prattika istituzzjonali b'ursodeoxycholic acid jew defibrotide.
English: 2.2 Qualitative and quantitative composition
Maltese: Għamla kwalitattiva u kwantitattiva
English: Prophylaxis for hepatic veno-occlusive disease (VOD) is recommended.
Maltese: Hija rrakkomandata profilassi għall-marda veno-okklussiva tal-fwied (VOD, hepatic veno-occlusive disease).
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Maltese: FARMAĊEWTIKU Lista ta' eċċipjenti
English: Zynteglo has not been studied in patients >65 years of age.
Maltese: Zynteglo ma ġiex studjat f'pazjenti li għandhom >65 sena.
English: Hypokalaemia, Hypomagnesaemia
Maltese: Iponatremija, Ipofosfatemija
English: Very Common (≥10%)
Maltese: Komuni Ħafna (≥10%)