FrancophonIA/ELRC3.0 huggingface dataset:
English: Infections
Maltese: EFFETTI
English: Headache was the most frequent of the flu-like symptoms.
Maltese: Uġigħ ta' ras kien l-iktar frekwenti minn dawn is-simptomi.
English: One case of JC virus infection resulting in PML has been reported in post-marketing surveillance in a patient with psoriasis receiving Raptiva (see section 4.8).
Maltese: Każ wieħed ta' infezzjoni tal-JC virus riżultanti f ' PML ġie rrapurtat waqt is-sorveljanza wara ttpoġġija fis-suq, f'pazjent li jsofri bil-psorijasi u li kien qed jieħu Raptiva (ara sezzjoni 4.8).
English: Raptiva is a selective immunosuppressor that alters T-lymphocyte function and may affect host defences against infections.
Maltese: Raptiva huwa immunosuppressor selettiv li għandu effett fuq il-funzjoni ta' T-lymphocytes u għalhekk jista' jaffetwa id-defenzi tal-ġisem kontra infezzjonijiet.
English: Efalizumab is a recombinant humanized monoclonal antibody produced in genetically engineered Chinese Hamster Ovary (CHO) cells.
Maltese: Efalizumab huwa monoclonal antikorpu umanizzat rikombinat li jiġi magħmul fiċ-ċelloli ta' l-ovarji tal-ħamster Ċiniż (CHO) li għandhom materjal ġenetiku mibdul.
English: Raptiva can be used in combination with topical corticosteroids.
Maltese: Raptiva jista' jintuża ma' cotrticosterojdi topikali.
English: The efficacy of Raptiva versus other systemic therapies in patients with moderate to severe psoriasis has not been evaluated in studies directly comparing Raptiva with other systemic therapies.
Maltese: L-effikaċja ta' Raptiva kontra terapiji sistemiċi oħrajn f'pazjienti b'psorjażi moderata - severa, għadu ma ġiex evaluat fi studji li jikkomparaw direttament Raptiva ma' terapiji sistemiċi oħrajn.
English: - If you have been diagnosed as having a disorder of your immune system.
Maltese: - Jekk ġejt dianostikat bi diżordni tas-sistemi immuni.
English: When taking Raptiva you might be more vulnerable to infections (see Take special care with Raptiva) this effect might be enhanced by other medicines that are used to treat psoriasis and that also make you more vulnerable to infections.
Maltese: Meta qed tieħu Raptiva, tista jsir iktar vulnerabbli għal infezzjonijiet (ara ‘Qogħod attent ma' Raptiva).
English: In the first 12 weeks of placebo-controlled studies, the rate of psoriasis adverse events was 3.2% in the Raptiva-treated patients and 1.4% in the placebo-treated patients.
Maltese: Fl-ewwel 12-il ġimgħa ta' studji kontrollati minn plaċebo, ir-rata ta effetti mhux mixtieqa ta' psorjażi kien 3.2% f'dawk il-pazjienti taħt il-kura ma' Raptiva u 1.4% fil-pazjienti kkurati minn plaċebo.
English: As regards serious infections, the overall incidence in both controlled and uncontrolled studies of up to 12 weeks was 2.8 per 100 patient-years for Raptiva-treated patients compared with 1.4 per 100 patient-years for placebo-treated patients.
Maltese: 7% knotra 22.3% f'pazjienti fuq plaċebo. , F'każijiet ta' infezzjonijiet serji, fuq kollox, fi studji kontrollati kif ukoll dawk li ma kienux kontrollati, sa 12-il sena, kien 2.8/ 100 patientyears għal dawk il-pazjienti fuq Raptiva, ikkomparat ma' 1.4/100 patient-years għal pazjienti fuq plaċebo.
English: Investigations
Maltese: Disturbi
English: Symptoms that might indicate that you have an infection are fever, wounds, feeling tired, dental problems, a bad cough that lasts longer than 2 weeks, pain in the chest or coughing up blood or sputum.
Maltese: Sintomi li jistgħu jindikaw li għandhek infezzjoni huma d-deni, ferita, tħossok għajjien, problemi bi snien, sogħla li jdum aktar minn ġimgħatejn, uġigħ f'sidrek jew tisgħol bid-demm jew sputum.
English: There are no comparative data with Raptiva versus other systemic psoriasis therapies.
Maltese: Ma hemx informazzjoni li tikkompara Raptiva ma' terapiji sistemiċi oħra għal psorjażi.
English: (n=529) b contraindicated to, or intolerant to two or
Maltese: (n=529) b
English: Leucocytosis and lymphocytosis: in large placebo-controlled and in long-term clinical studies, between 40 and 50% of patients developed sustained asymptomatic lymphocytosis during Raptiva therapy.
Maltese: Fi studji kliniċi kbar ikkontrollati minn plaċebo u fit-tul taz-żmien, bejn 40 u 50% ta' pazjienti zviluppaw limfoċitosi minn simpotmi sostnat, waqt kura ma' Raptiva.
English: HOW TO STORE RAPTIVA
Maltese: Reazzjonijiet avversi tal-klassi
English: Other therapies that alter T-lymphocyte function have been associated with increased risk of developing serious infections.
Maltese: Terapiji oħrajn li għandhom effett fuq il-funzjoni ta' limfoċiti T, ġew assoċjati ma' riskju akbar għal lizvilupp ta' infezzonijiet serji.
English: Analysis following long-term use in a cohort of 339 patients with moderate to severe psoriasis receiving Raptiva 1 mg/kg/week, of which 166 patients have been treated for more than 2 years and up to 3 years, did not show any noteworthy differences in frequency of adverse events as compared to 12 weeks of exposure to Raptiva.
Maltese: Analiżi li seħħ wara l-użu fit-tul f'grupp ta' 339 pazjienti b'psorjażi moderat- sever li rrċevew Raptiva 1mg/kg/week ,minn liema 166 pazjienti kienu taħt il-kura għal aktar minn sentejn sa tlett snin, ma wrex xi differenżi partikolari fil-frekwenza ta' effetti avversi, meta jiġi kkomparat ma' 12-il ġimgħa
English: A pneumococcal vaccine administered 6 weeks after discontinuation of Raptiva yielded normal results.
Maltese: Tilqima tal-pnemuococcal li ngħata 6 ġimgħat wara li twqqaf ir-Raptiva tagħ rizultati normali.
English: About 5.7% of patients developed elevation in ALT during Raptiva therapy compared to 3.5% in placebo.
Maltese: Madwar 5.7% ta pazjienti sviluppaw elevazzjoni ta ALT waqt il-kura ma' Raptiva, meta dan jiġi ikkomparat ma' dawk fuq plaċebo.
English: Four of these patients had clinical signs of thrombocytopenia.
Maltese: Erbgħa minn dawn il-pazjienti kellhom sinjali kliniċi ta' tromboċitopenja.
English: Lymphocyte count returned to baseline after therapy discontinuation.
Maltese: TAGĦTIHIEX lil persuni oħra.
English: Excretion of efalizumab in human milk has not been investigated, however immunoglobulins are expected to be excreted in human milk.
Maltese: Eskrezzjoni ta' efalizumab fil-ħalib uman ma ġiex studjat, pero immunoglobulini huma mistennija li jiġu eskrezzjati fil-ħalib uman.
English: Anaphylaxis is a more serious allergic reaction that may involve dizziness, vomiting, low blood pressure, and difficulty with breathing.
Maltese: Anafilassi huwa reazzjoni allerġika iktar serja u jista jinvolvi sturdament, rimettar, pressjoni baxxa, u diffikolta' fin-nifs.
English: In this small number of patients no differences were observed in pharmacokinetics, pharmacodynamics, clinically noteworthy adverse events or clinical efficacy.
Maltese: F'dan in-numru zgħar ta' pazjienti ma ġew osservati l-ebda differenzi fil- farmakokinetiku, farmakodinamiku, effetti mhux mixtieqa ta'
English: Monoclonal antibodies are proteins that recognise and bind to other specific proteins of the human body.
Maltese: Dawn huma proteini li jagħrfu u jintrabtu ma' proteini speċifiċi oħra tal-ġisem uman.
English: • Gently tap the syringe to make any bubbles rise to the top of the syringe.
Maltese: • Tinnota ipersensittivita' eċċessiva jew reazzjonijiet allerġiċi, bħal anafilassi.
English: • Fever or if you think that you have an infection.
Maltese: • Deni jew taħseb li għandek infezzjoni.
English: Patients with specific forms of psoriasis like guttate, erythrodermic or pustular psoriasis as sole or
Maltese: Pazjienti b'formi speċifii ta' psorajiżi bħal guttate, erythrodermic jew pustular psorajiżi, bħala l-uniku
English: Inhibitory effects were observed on the humoral and T-cell dependent immune responses.
Maltese: Effetti ħabitarji kienu osservati fuq ir-rispoti immuni li huma dipendenti fuq ċelluli-T u humoral.
English: Page 2/2
Maltese: Paġna 2/3
English: Dr Ondřej Slanař (Czech Republic)
Maltese: Dr Ondřej Slanař (ir-Repubblika Ċeka)
English: Prof János Borvendég (Hungary)
Maltese: Prof János Borvendég (l-Unġerija)
English: Ref.: EMEA/CHMP/675340/2009 rev. EMEA/H/A-29/1118
Maltese: EMEA/CHMP/675340/2009 rev.
English: London, 09 August 2010 Doc.
Maltese: Londra, 9 ta' Awwissu 2010
English: What is Myderison?
Maltese: X'inhu Myderison?
English: Company responses provided on: 4 May 2009 Opinion date:
Maltese: Ir-risposti tal-kumpanija ġew provduti nhar l-4 ta' Mejju 2009 Data tal-opinjoni:
English: 1 Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health
Maltese: 1 Artikolu 29 tad-Direttiva 2001/83/KE kif emendat, riferiment abbażi ta' riskju potenzjalment serju għas-saħħa pubblika.
English: Questions and answers on the referral for Myderison tablets containing tolperisone hydrochloride 50 and 150 mg
Maltese: Mistoqsijiet u tweġibiet dwar ir-riferiment għal Myderison pilloli li fihom tolperisone hydrochloride 50 u 150 mg
English: Myderison is a medicine that is used to treat skeletal muscle spasticity (stiffness of voluntary muscles).
Maltese: Myderison huwa mediċina li tintuża biex tiġi trattata spastiċità fil-muskolu skeletali (ebusija talmuskoli volontarji).
English: The review was carried out under an ‘Article 29' referral1.
Maltese: Ir-reviżjoni saret skont ir-riferiment tal-‘Artikolu 29'1.
English: Why was Myderison reviewed?
Maltese: Għalxiex ġie rivedut Myderison?
English: The active substance in Myderison, tolperisone, is a centrally acting muscle relaxant.
Maltese: Is-sustanza attiva f'Myderison, tolperisone, hija rilassant tal-muskolu li jaħdem b'mod ċentrali.
English: • the company had not presented sufficient information on the way the medicine is dealt with by the body (pharmacokinetics);
Maltese: • il-kumpanija ma ppreżentatx informazzjoni biżżejjed dwar il-mod kif il-mediċina tiġi trattata millġisem (farmakokinetiċi);
English: Meditop Pharmaceutical Co. Ltd submitted Myderison for mutual recognition on the basis of the initial authorisation granted by Hungary on 28 March 2006.
Maltese: Meditop Pharmaceutical Co. Ltd. issottomettiet Myderison għal rikonoxximent reċiproku abbażi talawtorizzazzjoni inizjali mogħtija mill-Ungerija fit-28 ta' Marzu 2006.
English: By reducing these impulses, tolperisone is expected to reduce muscle contraction, helping to relieve the stiffness.
Maltese: Bittnaqqis ta' dawn l-impulsi, tolperisone mistenni li jnaqqas il-kontrazzjoni tal-muskoli, u jgħin biex titnaqqas l-ebusija.
English: The company wanted the authorisation to be recognised in the Czech Republic, Germany, Lithuania, Poland and Slovakia (the concerned Member States).
Maltese: Il-kumpanija riedet li lawtorizzazzjoni tkun rikonoxxuta fir-Repubblika Ċeka, il-Ġermanja, il-Litwanja, il-Polonja u sSlovakkja (l-Istati Membri kkonċernati).
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Myderison.
Maltese: L-Aġenzija Ewropea għall-Mediċini temmet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost l-Istati Membri tal-Unjoni Ewropea (UE) rigward l-awtorizzazzjoni tal-mediċina Myderison.
English: • interactions with other medicines had not been adequately evaluated in pre-clinical and clinical studies.
Maltese: • l-interazzjonijiet ma' mediċini oħra ma ġewx evalwati b'mod adegwat fl-istudji prekliniċi u kliniċi.
English: The exact way tolperisone works is not known, but it is thought to act in the brain and spinal cord to reduce the nerve impulses that make the muscles contract and become rigid.
Maltese: Mhux magħruf il-mod eżatt kif jaħdem tolperisone, iżda huwa maħsub li jaħdem fil-moħħ u fis-sinsla taddahar biex inaqqas l-impulsi tan-nervituri li jġiegħelu lill-muskoli biex jinġibdu u jsiru riġidi.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Myderison do not outweigh its risks, and therefore the marketing authorisation should not be granted in the concerned Member States.
Maltese: Il-Kumitat għall-Prodottti Mediċinali għall-Użu mill-Bniedem tal-Aġenzija (CHMP) ikkonkluda li l-benefiċċji ta' Myderison ma jisbqux ir-riskji tiegħu, u l-awtorizzazzjoni għat-tqegħid fis-suq mogħtija fl-Ungerija ma tistax tiġi rikonoxxuta fi Stati Membri oħrajn tal-UE.
English: However, the Member States were not able to reach an agreement and the Hungarian medicines regulatory agency referred the matter to the CHMP for arbitration on 20 December 2008.
Maltese: Madankollu, l-Istati Membri ma setgħux jilħqu qbil u laġenzija Ungeriża li tirregola l-mediċini rreferiet il-kwistjoni lis-CHMP għal arbitraġġ fl-20 ta' Diċembru 2008.
English: Further information on Tovanor Breezhaler can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: Aktar informazzjoni dwar Tovanor Breezhaler tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Tovanor Breezhaler (glycopyrronium bromide) EMA/326862/2018
Maltese: Tovanor Breezhaler (bromur tal-glikopirronju)EMA/326862/2018
English: Tovanor Breezhaler (glycopyrronium bromide)
Maltese: Tovanor Breezhaler (bromur tal-glikopirronju)
English: Other information about Tovanor Breezhaler
Maltese: Informazzjoni oħra dwar Tovanor Breezhaler
English: Tovanor Breezhaler was found to be more effective than placebo (a dummy treatment) at relieving symptoms of COPD in two main studies involving a total of 1,888 patients with COPD.
Maltese: Tovanor Breezhaler instab li kien aktar effettiv mill-plaċebo (kura finta) fit-taffija tas-sintomi ta' COPD f'żewġ studji ewlenin li involvew total ta' 1,888 pazjent b'COPD.
English: The most common side effects with Tovanor Breezhaler (seen in more than 1 patient in 100) are dry mouth, nasopharyngitis (inflammation of the nose and throat), insomnia (difficulty sleeping), muscle and bone pain and gastroenteritis (diarrhoea and vomiting).
Maltese: L-effetti sekondarji l-aktar komuni b'Tovanor Breezhaler (li dehru f'aktar minn pazjent 1 minn 100) huma ħalq xott, nasofarinġite (infjammazzjoni tal-imnieħer u tal-gerżuma), insomnja (diffikultà flirqad), uġigħ fl-għadam u fil-muskoli u gastroenterite (dijarrea u remettar).
English: The active substance in Tovanor Breezhaler, glycopyrronium bromide, is a muscarinic receptor antagonist.
Maltese: Is-sustanza attiva f'Tovanor Breezhaler, il-bromur tal-glikopirronju, hija antagonista tar-riċettur muskariniku.
English: Tovanor Breezhaler contains the active substance glycopyrronium bromide.
Maltese: Tovanor Breezhaler fih is-sustanza attiva bromur tal-glikopirronju.
English: Tovanor Breezhaler received a marketing authorisation valid throughout the EU on 28 September
Maltese: Tovanor Breezhaler irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-28 ta' Settembru
English: Tovanor Breezhaler is a medicine that is used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Maltese: Tovanor Breezhaler huwa mediċina li tintuża biex ittaffi s-sintomi tal-marda pulmonari ostruttiva kronika (COPD) fl-adulti.
English: As for all medicines, data on the use of Tovanor Breezhaler are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Tovanor Breezhaler hija ssorveljata kontinwament.
English: After 12 weeks of treatment, Tovanor Breezhaler increased FEV1 by 97 ml more than with placebo in the first study, and by 108 ml more in the second study.
Maltese: Wara 12-il ġimgħa ta' kura, Tovanor Breezhaler żied FEV1 b'97 ml aktar mill-plaċebo fl-ewwel studju, u b'108 ml aktar fit-tieni studju.
English: In addition, there were no major safety concerns with Tovanor Breezhaler, with side effects similar to other muscarinic receptor antagonist medicines.
Maltese: Barra minn dan, ma kien hemm ebda tħassib maġġuri dwar is-sigurtà b'Tovanor Breezhaler, b'effetti sekondarji li huma simili għal mediċini antagonisti tar-riċettur muskariniku.
English: Tovanor Breezhaler is used for maintenance (regular) treatment.
Maltese: Tovanor Breezhaler jintuża għall-kura ta' manutenzjoni (regolari).
English: What are the risks associated with Tovanor Breezhaler?
Maltese: X'inhuma r-riskji assoċjati ma' Tovanor Breezhaler?
English: How does Tovanor Breezhaler work?
Maltese: Kif jaħdem Tovanor Breezhaler?
English: Why is Tovanor Breezhaler authorised in the EU?
Maltese: Għaliex Tovanor Breezhaler ġie awtorizzat fl-EU?
English: Side effects reported with Tovanor Breezhaler are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Tovanor Breezhaler huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: The full EPAR for Parsabiv 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: It contains the active substance etelcalcetide.
Maltese: Fih is-sustanza attiva etelcalcetide.
English: In the third study, Parsabiv was found to be at least as effective as cinacalcet: in 68% (232 out of 340) patients given Parsabiv compared with 58% (198 out of 343) patients given cinacalcet.
Maltese: Fit-tielet studju, Parsabiv instab li kien tal-anqas effettiv daqs cinacalcet: fi 68% (232 minn 340) tal-pazjenti li ngħataw Parsabiv meta mqabbla ma' 58% (198 minn 343) tal-pazjenti li ngħataw cinacalcet.
English: The active substance in Parsabiv, etelcalcetide, is a calcimimetic.
Maltese: Is-sustanza attiva f'Parsabiv, etelcalcetide, huwa kalċimimetiku.
English: In the first two studies, Parsabiv was effective in 75% (380 out of 509) of patients compared with 9% (46 out of 514) of patients given placebo.
Maltese: Fl-ewwel żewġ studji, Parsabiv kien effettiv f'75% (380 minn 509) tal-pazjenti meta mqabbla ma' 9% (46 minn 514) tal-pazjenti li ngħataw plaċebo.
English: Other information about Parsabiv
Maltese: Informazzjoni oħra dwar Parsabiv
English: This is a summary of the European public assessment report (EPAR) for Parsabiv.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Parsabiv.
English: Parsabiv has been investigated in three main studies involving 1,706 patients on haemodialysis who had long-term kidney disease and secondary hyperparathyroidism.
Maltese: Parsabiv ġie investigat fi tliet studji ewlenin li fihom ħadu sehem 1,706 pazjenti fuq emodijalisi li kellhom mard tal-kliewi fit-tul u iperparatirojdiżmu sekondarju.
English: Why is Parsabiv approved?
Maltese: Għaliex ġie approvat Parsabiv?
English: The most common side effects with Parsabiv (which may affect more than 1 in 10 people) are low calcium level in the blood, muscle spasm, diarrhoea, nausea (feeling sick) and vomiting.
Maltese: L-effetti sekondarji l-aktar komuni b'Parsabiv (li jistgħu jaffettwaw aktar minn 1 minn kull 10) huma livell baxx ta' kalċju fid-demm, spażmi fil-muskoli, dijarea, nawżja (dardir) u rimettar.
English: What are the risks associated with Parsabiv?
Maltese: X'inhuma r-riskji assoċjati ma' Parsabiv?
English: Parathyroid hormone is produced by the parathyroid glands in the neck and regulates calcium and phosphate levels.
Maltese: L-ormon tal-paratirojde jiġi prodott fil-glandoli tal-paratirojde fl-għonq u jirregola l-livelli tal-kalċju u tal-fosfat.
English: Parsabiv etelcalcetide
Maltese: Sommarju tal-EPAR għall-pubbliku etelcalcetide
English: The main measure of effectiveness was a reduction in parathyroid hormone by more than 30% after at least 20 weeks of treatment.
Maltese: Il-kejl ewlieni tal-effikaċja kien tnaqqis ta' aktar minn 30% fl-ormon tal-paratirojde wara tal-anqas20 ġimgħa ta' kura.
English: Parsabiv is a medicine used to reduce the levels of parathyroid hormone in adults who have high levels of this hormone because of their long-term kidney disease (secondary hyperparathyroidism).
Maltese: Parsabiv huwa mediċina li tintuża biex tnaqqas il-livelli tal-ormon tal-paratirojde fl-adulti li għandhom livelli għoljin ta' dan l-ormon minħabba l-marda tal-kliewi fit-tul tagħhom (iperparatirojdiżmu sekondarju).
English: The medicine has been found effective for reducing parathyroid hormone in the blood in patients with kidney disease being treated with haemodialysis and its side effects are those expected of a calcimimetic substance.
Maltese: Il-mediċina nstabet li hija effettiva fit-tnaqqis tal-ormon tal-paratirojde fid-demm f'pazjenti b'mard tal-kliewi li jkunu qegħdin jingħataw kura b'emodijalisi u l-effetti sekondarji tagħha huma dawk mistennija minn sustanza kalċimimetika.
English: Parsabiv is used in patients on haemodialysis (a technique for removing waste products from the blood using a blood filtration machine).
Maltese: Parsabiv jintuża fuq pazjenti fuq emodijalisi (teknika għall-purifikazzjoni tad-demm permezz ta' magna li tiffiltra d-demm).
English: How is Parsabiv used?
Maltese: Kif jaħdem Parsabiv?
English: In some circumstances, it can be given by injection into a vein.
Maltese: F'ċerti ċirkostanzi, jista' jingħata permezz ta' injezzjoni f'vina.
English: High levels of parathyroid hormone can cause loss of calcium from the bones, bone pain and fractures, and heart and circulation problems.
Maltese: Livelli għoljin tal-ormon tal-paratirojde jistgħu jikkawżaw telf ta' kalċju millgħadam, uġigħ u ksur fl-għadam, u problemi tal-qalb u fiċ-ċirkolazzjoni.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Parsabiv's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Parsabiv huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: London, 19 March 2008 Doc.
Maltese: Londra, 19 ta' Marzu 2008 Dok. Ref.
English: Ref. EMEA/CHMP/145497/2008
Maltese: EMEA/224469/2008
English: What is CIMZIA?
Maltese: X'inhu CIMZIA?
English: International non-proprietary name (INN): certolizumab pegol
Maltese: Denominazzjoni Komuni Internazzjonali (INN): certolizumab pegol
English: The active substance in CIMZIA, certolizumab pegol, is an immunosuppressant medicine.
Maltese: Is-sustanza attiva hija CIMZIA, certolizumab pegol, hija mediċina immunosuppressanti.
English: On 15 November 2007, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product CIMZIA 200 mg powder and solvent for solution for injection, intended for the treatment of severe, active Crohn's disease.
Maltese: Fil-15 ta' Novembru 2007, il-Kumitat għal Prodotti Mediċinali għal Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, u rrikmanda r-rifjut ta' l-awtorizzazzjoni tat-tqegħid fis-suq għall-prodott mediċinali CIMZIA 200 mg fi trab u solvent għas-soluzzjoni f'forma ta' injezzjoni, intiża għattrattament tal-marda attiva ta' Crohn f'forma severa.
English: It contains the active substance certolizumab pegol.
Maltese: Fih issustanza attiva eculizumab pegol.
English: In November 2007, the CHMP was concerned that there was insufficient evidence to show a benefit of CIMZIA.
Maltese: F'Novembru 2007, is-CHMP kienet konċernata li ma kienx hemm evidenza biżżejjed li turi lbenefiċċji ta' CIMZIA.
English: The second study looked at the maintenance of the medicine's effects in 428 patients who had responded to an initial six-week course of CIMZIA.
Maltese: It-tieni studju ħares lejn iż-żamma ta' l-effetti tal-mediċina f'428 pazjent li rrispondew għal kors inizjali ta' sitt ġimgħat ta' CIMZIA.
English: The company that applied for authorisation is UCB Pharma SA.
Maltese: Il-kumpanija li applikat għall-awtorizzazzjoni hija UCB Pharma
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found in the body.
Maltese: Antikkorp monoklonali hu tip ta' antikorp (tip ta' proteina) li ġiet immarkata biex tagħraf u teħel ma' struttura speċifika (magħrufa bħala antiġen) li tinstab fil-ġisem.
English: It includes certolizumab, which is part of a monoclonal antibody.
Maltese: Fih iċcertolizumab, li hija parti monoklonali ta' antikorp.