FrancophonIA/ELRC3.0 huggingface dataset:
English: If rapid protection against hepatitis B is required, the standard three dose regimen of the combined vaccine containing 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen is recommended.
Maltese: Jekk ikun hemm ħtieġa ta' protezzjoni ta' malajr kontra l-epatite B, hi rakkomandata il-kura standard ta' tliet dożi tat-tilqima kombinata li jkun fiha 360 Unitajiet ELISA tal-virus ta' l-epatite A inattivat bil-formalina u 10 mikrogrammi ta' antiġen tal-wiċċ ta' l-epatite B rikombinanti.
English: • Ambirix can only help to protect you against infections with hepatitis A or B viruses.
Maltese: • Ambirix jista' biss jgħin biex jipproteġi lilek kontra l-virus tal-epatite A jew B.
English: NAME OF THE MEDICINAL PRODUCT Ambirix - Suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Maltese: TAL-PRODOTT MEDIĊINALI Ambirix- Suspensjoni għall-injezzjoni f'siringa mimlija għal-lest Vaċċin (adsorbit) ta' l-epatite A (inattivat) u epatite B(r DNA) (HAB)
English: Upon storage, a fine white deposit with a clear colourless layer above may be observed.
Maltese: Id-data ta' meta jiskadi tirreferi għall-aħħar ġurnata ta' dak ix-xahar.
English: NAME OF THE MEDICINAL PRODUCT Ambirix suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed).
Maltese: Ambirix suspensjoni għal injezzjoni f'siringa mimlija għal-lest Tilqima (adsorbita) ta' l-epatite A (inattivata) u epatite B (rDNA) (HAB).
English: Very rare (These may occur with up to 1 in 10,000 doses of the vaccine): • hives (urticaria)
Maltese: Rari ħafna (Dawn jistgħu jseħħu f'sa doża 1 minn kull 10,000 doża tal-vaċċin) • ħorriqija (urtikarja)
English: Rare (These may occur with up to 1 in 1,000 doses of the vaccine) :
Maltese: Rari (Dawn jistgħu jseħħu f'sa doża 1 minn kull 1,000 doża tal-vaċċin)
English: LIST OF EXCIPIENTS Sodium chloride Water for injections
Maltese: TA' EĊĊIPJENTI Sodium chloride Ilma għall-injezzjonijiet
English: • a degenerative disease of the brain (encephalopathy)
Maltese: • marda deġenerattiva tal-moħħ (enċefalopatija)
English: • Ambirix is available in packs of 1 and 10 pre-filled syringes (with or without needles) and in pack sizes of 50 pre-filled syringes without needles.
Maltese: • Ambirix huwa disponibbli f'pakketti b'siringa waħda mimlija għal-lest u b'10 siringi mimlija għal lest (b'labar jew mingħajr labar) u f'daqsijiet ta' pakkett ta' 50 siringa mimlija għal-lest mingħajr labar.
English: For the 289 subjects evaluable for immunogenicity, seroprotection rates (SP in the table below) against hepatitis B were significantly higher at months 2 and 6 with the three-dose vaccine than with Ambirix.
Maltese: Għall-289 individwu li ġew evalwati għal immuoġeniċità, ir-rati ta' seroprotezzjoni (SP fit-tabella t'hawn taħt) kontra l-epatite B kienu sostanzjalment ogħla fix-xhur numru 2 u numru 6 meta ngħataw t-tilqima ta' tlirt dożi ta` vaċċin milli meta ngħataw Ambirix.
English: It is used to prevent two diseases: hepatitis A and hepatitis B.
Maltese: Jintuża biex jipprevjeni żewġ mardiet: l-epatite A u l-epatite B.
English: Age group
Maltese: Grupp ta' etajiet
English: • swollen glands in the neck, armpit or groin (lymphadenopathy)
Maltese: • nefħa fil-wiċċ, ħalq u griżmejn (edima anġjonewrotika)
English: General disorders and administration site conditions Very common: fatigue, pain and redness at the injection site Common: fever, swelling at the injection site
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni ħafna: għeja, uġigħ u ħmura fis-sit tal-injezzjoni Komuni: deni, nefħa fis-sit tal-injezzjoni
English: • joint pain (arthralgia)
Maltese: • tingiż (paresteżija)
English: The most commonly reported adverse reactions following Ambirix administration are pain and fatigue occurring in an approximated per dose frequency of 50% and 30% respectively.
Maltese: L-aktar reazzjonijiet avversi rrappurtati b'mod komuni wara għoti ta' Ambirix huma uġigħ u għeja li jseħħu bi frekwenza ta' madwar 50% u 30% rispettivament minn kull doża li tingħata.
English: Vascular disorders Vasculitis
Maltese: Grupp tal-vaċċin
English: Tel: + 31 (0)30 69 38 100 nlinfo@gsk.com
Maltese: GlaxoSmithKline BV Tel: + 31 (0)30 69 38 100 nlinfo@gsk.com
English: Side effects that occurred during routine use of Ambirix were as follows:
Maltese: Effetti sekondarji li seħħew waqt użu normali ta' Ambirix kienu kif ġej:
English: Package Leaflet: Information for the user Ambirix suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Maltese: Informazzjoni għall-utent Ambirix suspensjoni għall-injezzjoni f'siringa mimlija għal-lest Vaċċin (adsorbit) ta' l-epatite A (inattivat) u l-epatite B (rDNA) (HBV)
English: • stomach and digestive problems
Maltese: • problemi fl-istonku u fis-sistema diġestiva
English: The following adverse reactions were reported during clinical trials with Ambirix.
Maltese: Ir-reazzjonijiet avversi li ġejjin kienu rrappurtati waqt provi kliniċi b'Ambirix.
English: Infections and infestations Meningitis
Maltese: Disturbi gastro-intestinali
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline Biologicals s.a.
Maltese: Isem u indirizz tal-manifattur tas-sustanzi bijoloġiċi attivi
English: How to store Ambirix
Maltese: Kif jaħdem Ambirix
English: The virus is usually caught from another infected person.
Maltese: Il-virus ġeneralment jittieħed minn persuna infettata oħra.
English: 3Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4Adsorbed on aluminium phosphate,
Maltese: 0.05 milligrammi Al3+ 3Magħmul f'ċelluli tal-ħmira (Saccharomyces cerevisiae) b'teknoloġija rikombinanti tad-DNA Adsorbit fuq aluminium phosphate,
English: Ambirix should only be used during breast-feeding when the possible advantages outweigh the potential risks.
Maltese: Ambirix għandu jintuża waqt it-treddigħ biss meta l-vantaġġi possibbli huma akbar mir-riskji potenzjali.
English: • swelling of the face, mouth and throat (angioneurotic oedema)
Maltese: • dijarea, tħossok imdardar (tqalligħ)
English: • Ambirix is a white, slightly milky liquid presented in a glass 1 ml pre-filled syringe.
Maltese: • Ambirix jgħin lill-ġisem jipproduċi l-protezzjoni tiegħu stess (antikorpi) kontra dan il-mard.
English: When the first dose of Ambirix was administered concomitantly with a booster dose of a combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (DTPa-IPV+Hib) or with the first dose of a combined Measles-Mumps-Rubella vaccine in the second year of life, immune responses to all antigens were satisfactory.
Maltese: Meta ngħatat l-ewwel doża ta'Ambirix flimkien ma doża ta' rinforz ta` vaċċin kombinat tad-difterite, tetnu, pertussis aċellulari, poljomelite inattivat u Haemophilus influenzae tat-tip b (DTPa-IPV+Hib) jew ma' l-ewwel doża ta` vaċċin kombinat kontra il-Ħożba, il-Ġidri u r-Rubella fit-tieni sena mittwelid, ir-rispons immuni għall-antiġeni kollha kien kif mixtieq.
English: In 2 comparative trials in subjects aged 1-15 years, the incidences of local and general solicited symptoms after a two dose regimen of Ambirix was overall similar to that seen with the three dose combined vaccine containing 360 ELISA Units of HAV and 10 µg of HBsAg.
Maltese: F'2 provi komparattivi f'individwi li għandhom minn 1-15-il sena, l-inċidenzi ta' sintomi lokali u ġenerali mfittxija wara skeda ta' żewġ dożi ta' Ambirix kienet globalment tixbah lil dik li dehret bi tliet dożi tat-tilqima mħallta li fiha 360
English: 3Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4Adsorbed on aluminium phosphate
Maltese: 0.05 milligramma Al3+ 3Magħmul f'ċelluli tal-ħmira (Saccharomyces cerevisiae) b'teknoloġija rikombinanti tad-DNA Adsorbit fuq aluminium phosphate
English: - Hepatitis B surface antigen 3,4
Maltese: - Antiġen tal-wiċċ ta' l-epatite B
English: Musculoskeletal and connective tissue disorders Uncommon: myalgia
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi
English: Adverse reactions reported are listed according to the following frequency: Very common:
Maltese: Ir-reazzjonijiet avversi rrappurtati huma elenkati skont il-frekwenza li ġejja:
English: • a temporary inflammation of the nerves, causing pain, weakness and paralysis in the arms and legs and often progressing to the chest and face (Guillain-Barré syndrome)
Maltese: • infjammazzjoni temporanja tan-nervaturi, li tikkawża uġigħ, dgħufija, u paraliżi fid-dirgħajn u r riġlejn u li ħafna drabi tinfirex għas-sider u l-wiċċ (sindrome ta' Guillain-Barré)
English: • They will take care that Ambirix is not given into a vein.
Maltese: • Huma se jieħdu ħsieb li Ambirix ma jingħatax ġo vina.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING 1 PRE-FILLED SYRINGE WITHOUT NEEDLE 1 PRE-FILLED SYRINGE WITH 1 NEEDLE 10 PRE-FILLED SYRINGES WITHOUT NEEDLES 10 PRE-FILLED SYRINGES WITH 10 NEEDLES 50 PRE-FILLED SYRINGES WITHOUT NEEDLES
Maltese: Pakketti b'siringa waħda jew b'10 siringi mimlija għal-lest bil-labar jew mingħajr labar u pakkett b'50 siringa mimlija għal-lest mingħajr labar.
English: Missing a dose
Maltese: Twissijiet u prekawzjonijiet
English: Pregnancy
Maltese: Vaskulite
English: In haemodialysis patients and persons with an impaired immune system, adequate anti-HAV and anti-HBs antibody titers may not be obtained after the primary immunisation course.
Maltese: F'pazjenti fuq dijaliżi tad-demm u oħrajn li għandhom problemi fis-sistema immuni, titri adegwati ta' antikorpi ta' kontra l-HAV u l-HBs jistgħu ma jinkisbux wara l-kors primarju ta' tilqim.
English: HAB vaccine
Maltese: KLINIKU
English: However, exceptionally Ambirix can be administered subcutaneously to subjects with thrombocytopenia or bleeding disorders since bleeding may occur following an intramuscular administration to these subjects.
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Uġigħ, tingiż u sensazzjoni ta' ħruq fis-sit immedjat tal-injezzjoni.
English: • headache
Maltese: • rimettar
English: • If you/your child gets any side effects, talk to your doctor, nurse or pharmacist.
Maltese: • Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib, lill-infermier jew lill-ispiżjar tiegħek.
English: Side effects that occurred during clinical trials with Ambirix were as follows:
Maltese: Effetti sekondarji li seħħew waqt provi kliniċi b'Ambirix kienu kif ġej:
English: • feeling dizzy
Maltese: • tħossok imħeddel
English: Hepatitis B surface antigen3,4
Maltese: Antiġen tal-wiċċ ta' l-epatite B
English: The vaccine does not contain live virus (see section 6 for the content of the vaccine) and therefore cannot cause hepatitis A or B infections.
Maltese: Ilvaċċin ma fihx il-virus ħaj (ara sezzjoni 6 għall-kontenut tal-vaċċin) u għalhekk ma jistax jikkawża infezzjonijiet tal-epatite A jew B.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted.
Maltese: Il-Ġustifikazzjoni biex ma' jkunx inkluż il-Braille hija aċċettata.
English: - Booster dose
Maltese: MINGHAJR LABAR
English: - Hepatitis A virus (inactivated) 1,2
Maltese: - Virus ta' l-epatite A (inattivat)
English: Concomitant vaccines should always be administered at separate injection sites and preferably into different limbs.
Maltese: Tilqim li jingħata flimkien għandu dejjem jingħata f`postijiet ta' injezzjoni differenti u preferibbilment fid-driegħ jew f'riġlejn differenti.
English: It is not yet fully established whether immunocompetent individuals who have responded to hepatitis A vaccination will require booster doses as protection in the absence of detectable antibodies may be ensured by immunological memory.
Maltese: Għad mhux stabbilit għal kollox jekk individwi immunokompetenti li fihom tkun ħadmet it-tilqima ta' l-epatite A jkollhomx bżonn ta' dożi ta' rinforz għax meta ma jkunx jidher li hemm antikorpi, ilprotezzjoni tista' tiġi assigurata permezz ta' memorja immunoloġika.
English: B. PACKAGE LEAFLET
Maltese: B'MOD INTRAVASKULARI
English: • Ambirix may not protect you from being ill if you have already caught the hepatitis A or B virus.
Maltese: • Ambirix jista' ma jipproteġix lilek milli timrad jekk inti diġà ħadt l-epatite A jew B.
English: If you are not sure, talk to your doctor, nurse or pharmacist before having Ambirix.
Maltese: Jekk m'intix ċert, kellem littabib, lill-infermier jew lill-ispiżjar qabel ma tieħu Ambirix.
English: • abnormal test results relating to the liver
Maltese: • reazzjonijiet fejn ingħatat l-injezzjoni
English: 10 November 2017 EMA/736863/2017 EMEA/H/C/003874
Maltese: 10 ta' Novembru 2017 EMA/736863/2017 EMEA/H/C/003874
English: The company that applied for authorisation is Nektar Therapeutics UK Limited.
Maltese: Il-kumpanija li applikat għal awtorizzazzjoni hija Nektar Therapeutics UK Limited.
English: What is Onzeald?
Maltese: X'inhu Onzeald?
English: Refusal of the marketing authorisation for Onzeald (etirinotecan pegol)
Maltese: Onzeald (etirinotecan pegol)
English: The active substance in Onzeald, etirinotecan pegol, consists of irinotecan (a cancer medicine that belongs to the group ‘topoisomerase inhibitors') that has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Maltese: Is-sustanza attiva f'Onzeald, l-etirinotekan pegol, tikkonsisti minn irinotekan (mediċina kontra l-kanċer li tappartjeni għall-grupp “inibituri ta' topojsomerażi”) li ġiet “pegilata” (twaħħlet ma' kimika li tissejjaħ polietilenglikol).
English: Onzeald is a cancer medicine that contains the active substance etirinotecan pegol.
Maltese: Onzeald huwa mediċina kontra l-kanċer li fih is-sustanza attiva l-etirinotekan pegol.
English: After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorisation on 9 November 2017.
Maltese: Wara li kkunsidra r-raġunijiet għal din it-talba, is-CHMP reġa' eżamina l-opinjoni, u kkonferma r-rifjut tal-awtorizzazzjoni għattqegħid fis-suq fid-9 ta' Novembru 2017.
English: On 20 July 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Onzeald, intended for the treatment of advanced breast cancer that has spread to the brain.
Maltese: Fl-20 ta' Lulju 2017, il-Kumitat għal Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, li fiha rrakkomanda r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq għall-prodott mediċinali Onzeald, maħsub għall-kura ta' kanċer tas-sider avvanzat li jkun infirex għall-moħħ.
English: What was Onzeald expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Onzeald?
English: Refusal of the marketing authorisation for Onzeald (etirinotecan pegol) EMA/736863/2017
Maltese: EMA/736863/2017
English: Irinotecan blocks topoisomerase I, an enzyme that is involved in copying cell DNA, which is needed to make new cells.
Maltese: Irinotecan jimblokka t-topojsomerażi I, enzima li hija involuta fl-ikkupjar tad-DNA taċċelluli, li huwa meħtieġ biex isiru ċelluli ġodda.
English: The claim of effectiveness relied on data from a subgroup of patients from a main study which, overall, failed to convincingly show the effectiveness of Onzeald.
Maltese: L-affermazzjoni tal-effikaċja ddependiet minn data minn sottogrupp ta' pazjenti minn studju ewlieni, li b'mod globali, ma werietx b'mod konvinċenti l-effikaċja ta' Onzeald.
English: Irinotecan has been authorised in the EU for a number of years for the treatment of colorectal cancer.
Maltese: Irinotecan ġie awtorizzat fl-UE għal numru ta' snin għall-kura ta' kanċer kolorettali.
English: The company presented the results of one main study involving 852 patients with breast cancer that had spread to other parts of the body who had been treated with at least 2 other cancer medicines.
Maltese: Il-kumpanija ppreżentat ir-riżultati ta' studju ewlieni wieħed li involva 852 pazjent b'kanċer tas-sider li kien infirex għal partijiet oħra tal-ġisem li ġew ikkurati b'tal-inqas 2 mediċini kontra l-kanċer oħra.
English: The Committee considered that the data from this subgroup, which were not supported by additional studies, were not sufficient to prove the effectiveness of Onzeald, even when analysed by different methods.
Maltese: Il-Kumitat ikkunsidra li d-data minn dan is-sottogrupp, li ma ġietx appoġġjata minn studji addizzjonali, ma kinitx biżżejjed biex turi l-effikaċja ta' Onzeald, anki meta ġiet analizzata b'metodi differenti.
English: It was to be available as a powder to be made into a solution for infusion (drip) into a vein.
Maltese: Dan kellu jiġi bħala trab biex isir soluzzjoni għall-infużjoni (dripp) ġo vina.
English: The company informed the CHMP that patients receiving the medicine in clinical trials will continue to do so as planned.
Maltese: Jekk inti qed tipparteċipa fi prova klinika u teħtieġ aktar informazzjoni dwar il-kura tiegħek, ikkuntattja lit-tabib li jkun qed jagħtik il-kura.
English: The mutual recognition procedure (UK/V/0354/001/MR) started on 26 November 2009.
Maltese: Il-proċedura ta' rikonoxximent reċiproku (UK/V/0354/001/MR) inbdiet fis-26 ta' Novembru 2009.
English: Oral explanations were given on 12 January 2011.
Maltese: L-ispjegazzjonijiet orali ngħataw fit-12 ta' Jannar 2011.
English: Written explanations were provided by the marketing authorisation holder on 13 September 2011 and 10 March 2011.
Maltese: Ingħataw spjegazzjonijiet bil-miktub mid-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq fit-13 ta' Settembru 2011 u fl-10 ta' Marzu 2011.
English: Combimox Lactating Cow Intramammary Suspension (Combimox) is an intramammary suspension containing amoxicillin, clavulanic acid and prednisolone.
Maltese: Combimox Sospensjoni Intramammarja għal Baqar li Jreddgħu (Combimox) hija sospensjoni intramammarja li fiha amoxicillin, clavulanic acid u prednisolone.
English: The marketing authorisation holder, Norbrook Laboratories Ltd, submitted an application for Combimox via a mutual recognition procedure in Ireland on the basis of the marketing authorisation granted by the United Kingdom.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq, Norbrook laboratories Ltd, issottometta applikazzjoni għal Combimox permezz ta' proċedura ta' rikonoxximent reċiproku fl-Irlanda abbażi talawtorizzazzjoni għat-tqegħid fis-suq mogħtija mir-Renju Unit.
English: On 2 July 2010, the United Kingdom, as Reference Member State, referred the matter to the European Medicines Agency under Article 33(4) of Directive 2001/82/EC, due to concerns raised by the Concerned Member State, Ireland, that the safety and efficacy of the product had not been sufficiently demonstrated.
Maltese: Fit-2 ta' Lulju 2010, ir-Renju Unit, bħala l-Istat Membru ta' Referenza, irrefera l-kwistjoni lill-Aġenzija Ewropea għall-Mediċini skont l-Artikolu 33(4) tad-Direttiva 2001/82/KE, minħabba tħassib imqajjem mill-Istat Membru Kkonċernat, l-Irlanda, li s-sigurtà u l-effikaċja tal-prodott ma kinux intwerew b'mod suffiċjenti.
English: The final opinion was converted into a Decision by the European Commission on 5 August 2011.
Maltese: L-opinjoni finali hija konvertita f'Deċiżjoni mill-Kummissjoni Ewropea fil-5 ta' Awwissu 2011.
English: EMA/660645/2015 EMEA/H/C/002611
Maltese: EMA/660645/2015 EMA/H/C/002611
English: The full EPAR and risk management plan summary for Numient 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: Other information about Numient
Maltese: Informazzjoni oħra dwar Numient
English: Numient levodopa / carbidopa
Maltese: Sommarju tal-EPAR għall-pubbliku levodopa / carbidopa
English: It contains the active substances levodopa and carbidopa.
Maltese: Fih is-sustanzi attivi levodopa u carbidopa.
English: Patients who took placebo had an average improvement of 0.6 points.
Maltese: Il-pazjenti li ħadu plaċebo kellhom titjib medju ta' 0.6 punti.
English: This is a summary of the European public assessment report (EPAR) for Numient.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Numient.
English: Why is Numient approved?
Maltese: Għaliex ġie approvat Numient?
English: What are the risks associated with Numient?
Maltese: X'inhuma r-riskji assoċjati ma' Numient?
English: 95 mg/23.75 mg, 145 mg/36.25 mg, 195 mg/48.75 mg and 245 mg/61.25 mg. For further information on how to use Numient, see the summary of product characteristic (also part of the EPAR).
Maltese: Numient jista' jinkiseb b'riċetta ta' tabib u huwa disponibbli bil-qawwiet li ġejjin: 95 mg/23.75 mg, 145 mg/36.25 mg, 195 mg/48.75 mg u 245 mg/61.25 mg.
English: The most frequent side effects with Numient are nausea in (12% of patients), dizziness, headache and involuntary movements (each occurring in 8% of patients), and insomnia (in 6% of patients).
Maltese: L-effetti sekondarji l-aktar frekwenti b'Numient huma nawsja (fi 12% tal-pazjenti), sturdament, uġigħ ta' ras u movimenti involontarji (li kull wieħed minnhom isseħħ fi 8% tal-pazjenti), u insomnja (f'6% tal-pazjenti).
English: After 30 weeks, patients taking Numient had their symptoms improve by an average of between 11.7 and 14.9 points (depending on dose) on a standard symptom scale (Unified Parkinson's Disease Rating Scale, UPDRS Part II and Part III).
Maltese: Wara 30 ġimgħa, il-pazjenti li kienu qegħdin jieħdu Numient kellhom titjib fis-sintomi tagħhom b'medja ta' bejn 11.7 u 14.9 punti (skont id-doża) fuq skala standard ta' sintomi (Skala Unifikata tal-Klassifikazzjoni tal-Marda ta' Parkinson, Parti II u Parti III talUPDRS).
English: A second study compared Numient with another treatment containing levodopa and carbidopa in 393 patients with advanced Parkinson's disease.
Maltese: Studju ieħor qabbel lil Numient ma' kura oħra li tinkludi levodopa u carbidopa fi 393 pazjent b'marda avvanzata ta' Parkinson.
English: Both groups had off periods of about 36-37% at the start of the study.
Maltese: Iż-żewġ gruppi kellhom off periods ta' madwar 36-37% fil-bidu tal-istudju.
English: The starting dose for patients who have not previously taken levodopa is one capsule containing 95 mg of levodopa and 23.75 mg of carbidopa, three times daily for the first three days.
Maltese: Id-doża tal-bidu għall-pazjenti li ma ħadux qabel levodopa hija kapsula kuljum li fiha 95 mg ta' levodopa u 23.75 mg ta' carbidopa, tliet darbiet kuljum għall-ewwel tlett ijiem.
English: Numient must not be used in patients with narrow angle glaucoma (an eye disorder) or pheochromocytoma (a tumour of the adrenal glands).
Maltese: Numient ma għandux jintuża f'pazjenti b'glawkoma b'angolu dejjaq (disturb fl-għajnejn) jew fejokromoċitoma (tumur tal-glandoli adrenali).
English: In Numient, a portion of the active substances is released immediately, while the remaining is released gradually, leading to more steady levodopa levels.
Maltese: F'Numient, parti mis-sustanzi attivi tiġi rilaxxata immedjatament, filwaqt li l-parti l-oħra li jifdal tiġi rilaxxata gradwalment, u dan iwassal għal livelli iktar stabbli ta' levodopa.
English: These types of capsules are known as modifiedrelease capsules.
Maltese: Dawn it-tipi ta' kapsuli huma magħrufin bħala kapsuli li jerħu l-mediċina b'mod modifikat.
English: The combination of levodopa and carbidopa is used in other medicines for Parkinson's disease.
Maltese: Il-kombinazzjoni ta' levodopa u carbidopa tintuża f'mediċini oħra għall-marda tal-Parkinson.
English: Numient is used in adults to treat the symptoms of Parkinson's disease, a progressive brain disorder that causes shaking and muscular stiffness and slows down movement.
Maltese: Numient jintuża fl-adulti biex jikkura s-sintomi tal-marda ta' Parkinson, disturb mentali progressiv li jikkawża rogħda u ebusija fil-muskoli u jdewwem il-moviment.
English: A risk management plan has been developed to ensure that Numient is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Numient jintuża bl-aktar mod sigur possibbli.