FrancophonIA/ELRC3.0 huggingface dataset:
English: How is Gilenya used?
Maltese: Kif jintuża Gilenya?
English: Side effects reported with Gilenya are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Gilenya huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: An overview of Gilenya and why it is authorised in the EU
Maltese: Ħarsa ġenerali lejn Gilenya u għalfejn huwa awtorizzat fl-UE
English: The checklist includes information on the tests and monitoring in patients before and during treatment with Gilenya.
Maltese: Il-lista tinkludi informazzjoni dwar ittestijiet u s-sorveljanza li għandha titwettaq f'pazjenti qabel u matul il-kura b'Gilenya.
English: The company that markets Gilenya will provide results from a study to assess the risk of side effects on the heart and circulation.
Maltese: Il-kumpanija li tqiegħed Gilenya fis-suq se twettaq studju biex tevalwa r-riskju tal-effetti sekondarji fuq il-qalb u ċ-ċirkolazzjoni.
English: In a study involving 215 children, Gilenya was compared with interferon beta-1a for up to 2 years.
Maltese: Fi studju li involva 215-il tifel u tifla, Gilenya tqabbel ma' interferon beta-1a fuq perjodu ta' mhux aktar minn sentejn.
English: On 8 February 2018, while the review was ongoing, the PRAC issue temporary recommendations.
Maltese: Fit-8 ta' Frar 2018, filwaqt li r-reviżjoni għadha għaddejja, il-PRAC ħareġ rakkomandazzjonijiet temporanji.
English: Ulipristal acetate is also the active substance of a single-dose medicine authorised for emergency contraception, ellaOne.
Maltese: L-aċetat ulipristal hija wkoll is-sustanza attiva ta' mediċina ta' doża waħda awtorizzata għal kontraċettiv ta' emerġenza, ellaOne.
English: The review of Esmya was initiated at the request of European Commission on 30 November 2017, under Article 20 of Regulation (EC) No 726/2004.
Maltese: Ir-reviżjoni ta' Esmya nbdiet fuq talba tal-Kummissjoni Ewropea fit-30 ta' Novembru 2017, skont lArtikolu 20 tar-Regolament (KE) Nru 726/2004.
English: • For any patient with signs or symptoms consistent with liver injury (such as nausea, vomiting, right hypochondrial pain, anorexia, asthenia, jaundice), check transaminase levels immediately.
Maltese: • Għal kull pazjenta b'sinjali jew b'sintomi konsistenti ma' ħsara fil-fwied (bħal dardir, rimettar, uġigħ ipokondriku fin-naħa tal-lemin, uġigħ, anoressija, astenija, suffejra), ivverifika l-livelli tattransaminażi immedjatament.
English: These recommendations are temporary measures to protect patients' health, pending the conclusion of the review of Esmya which started on 30 November 2017.
Maltese: Dawn irrakkomandazzjonijiet huma miżuri temporanji sabiex jipproteġu s-saħħa tal-pazjenti, sakemm ilkonklużjoni tar-reviżjoni ta' Esmya li bdiet fit-30 ta' Novembru 2017 għadha pendenti.
English: Following reports of liver injury and hepatic failure with Esmya, EMA has made the following temporary recommendations:
Maltese: Wara rapporti ta' ħsara fil-fwied u insuffiċjenza tal-fwied b'Esmya, l-EMA għamlet irrakkomandazzjonijiet temporanji li ġejjin:
English: Esmya was authorised in the EU in 2012 for the treatment of moderate to severe symptoms of uterine fibroids, which are non-cancerous (benign) tumours of the womb, in women who have not reached the menopause.
Maltese: Esmya ġie awtorizzat fl-UE fl-2012 għall-kura ta' sintomi moderati sa severi ta' fibrojdi fl-utru, li huma tumuri mhux kanċerużi (beninni) fl-utru, f'nisa li ma waslux sal-menopawża.
English: EMA's Pharmacovigilance Risk Assessment Committee (PRAC) is currently reviewing the benefits and risks with Esmya, following reports of serious liver injury, including liver failure leading to transplantation.
Maltese: Il-Kumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC) tal-EMA bħalissa qiegħed jirrevedi l-benefiċċji u r-riskji b'Esmya, wara rapporti ta' ħsara serja fil-fwied, inkluż insuffiċjenza talfwied li wasslet għal trapjant.
English: Since progesterone may promote the growth of fibroids, by preventing the effects of progesterone ulipristal acetate reduces the size of the fibroids.
Maltese: Peress li l-proġesteron jista' jippromwovi t-tkabbir tal-fibrojdi, billi jipprevjeni l-effetti talproġesteron, l-aċetat ulipristal tnaqqas id-daqs tal-fibrojdi.
English: If the tests indicate that you have a liver problem, your treatment will be stopped.
Maltese: Jekk it-testijiet jindikaw li għandek problema fil-fwied, il-kura tiegħek ser titwaqqaf.
English: If the test is abnormal (liver enzyme levels more than 2 times the upper limit of normal), the healthcare professional should stop treatment and closely monitor the patient.
Maltese: Jekk it-test ikun anormali (livelli tal-enzimi tal-fwied aktar minn darbtejn tallimitu massimu tan-normal), il-professjonista tal-kura tas-saħħa għandu jwaqqaf il-kura u jimmonitorja l-pazjenta mill-qrib.
English: The active substance in Esmya, ulipristal acetate, works by attaching to the targets on cells (receptors) that the hormone progesterone normally attaches to, preventing progesterone from having its effect.
Maltese: Is-sustanza attiva f'Esmya, l-aċetat ulipristal, taħdem billi teħel mal-miri fuq iċ-ċelloli (riċetturi) li lormon tal-proġesteron normalment jeħel magħhom, li b'hekk tipprevjeni milli l-proġesteron ikollu leffett tiegħu.
English: If transaminase levels are more than 2 times the upper limit of normal, stop treatment and closely monitor the patient.
Maltese: Jekk il-livelli tat-transaminażi jkunu aktar minn darbtejn il-limitu massimu tan-normal, waqqaf il-kura u mmonitorja l-pazjenta mill-qrib.
English: Liver test should be repeated 2 to 4 weeks after stopping treatment.
Maltese: It-test tal-fwied għandu jiġi ripetut ġimagħtejn sa 4 ġimgħat wara t-twaqqif tal-kura.
English: • Esmya, used to treat uterine fibroids, is being reviewed because cases of serious liver problems have occurred in women taking the medicine.
Maltese: • Esmya, li jintuża biex jikkura fibrojdi fl-utru, qiegħed jiġi rrevedut minħabba każijiet ta' problemi serji fil-fwied li seħħew f'nisa li kienu qegħdin jieħdu l-mediċina.
English: The PRAC's final recommendations will be forwarded to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt an opinion.
Maltese: Ir-rakkomandazzjonijiet finali tal-PRAC ser jintbagħtu lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP), responsabbli għal mistoqsijiet dwar il-mediċini għal użu mill-bniedem, li ser jadotta opinjoni finali.
English: • Advise your patients about the signs and symptoms of liver injury.
Maltese: • Informa lill-pazjenti tiegħek dwar is-sinjali u s-sintomi ta' ħsara fil-fwied.
English: • If you have nausea (feeling sick), vomiting, upper belly pain, lack of appetite, tiredness or yellowing of the eyes or skin, contact your doctor immediately as these could be signs of liver problems.
Maltese: • Jekk ikollok dardir (tħossok ma tiflaħx), rimettar, uġigħ fil-parti ta' fuq taż-żaqq, nuqqas ta' aptit, għeja jew sfurija tal-għajnejn jew tal-ġilda, ikkuntattja lit-tabib tiegħek immedjatament peress li dawn jistgħu jkunu sinjali ta' problemi fil-fwied.
English: If the patient develops transaminase levels more than 2 times the upper limit of normal, stop treatment and monitor the patient closely.
Maltese: Jekk il-pazjenta tiżviluppa livelli ta' transaminażi aktar minn darbtejn illimitu massimu tan-normal, waqqaf il-kura u mmonitorja l-pazjenta mill-qrib.
English: • Perform liver function tests at least once a month for all patients taking Esmya.
Maltese: • Agħmel testijiet tal-funzjoni tal-fwied tal-inqas darba fix-xahar għall-pazjenti kollha li jkunu qegħdin jieħdu Esmya.
English: • If you were about to start treatment with Esmya or start a new course of treatment, your doctor will put your treatment on hold until EMA's review of the medicine is complete.
Maltese: • Jekk ser tibda kura b'Esmya jew ser tibda kors ġdid ta' kura, it-tabib tiegħek ser jippostponi l-kura tiegħek sakemm ir-reviżjoni tal-EMA tal-mediċina tkun lesta.
English: More information on Esmya can be found here.
Maltese: Aktar informazzjoni dwar Esmya tista' tinsab hawn.
English: Zypadhera olanzapine
Maltese: Zypadhera olanzapina
English: The full EPAR for Zypadhera 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: The active substance in Zypadhera, olanzapine, is an antipsychotic medicine.
Maltese: Is-sustanza attiva f'Zypadhera, l-olanzapina, hija mediċina antipsikotika.
English: Zypadhera is given at doses of 150, 210 or 300 mg every two weeks, or 300 or 405 mg every four weeks.
Maltese: Zypadhera jingħata f'dożi ta' 150, 210 jew 300 mg kull ġimagħtejn, jew f'dożi ta' 300 jew 405 mg kull erba' ġimgħat.
English: Three of the doses of Zypadhera were ‘high' (300 mg and 150 mg every two weeks, and 405 mg every four weeks) and one was ‘low' (45 mg every four weeks).
Maltese: Tliet mid-dożi ta' Zypadhera kienu ‘għoljin' (300 mg u 150 mg kull ġimagħtejn, u 405 mg kull erba' ġimgħat) filwaqt li waħda kienet ‘baxxa' (45 mg kull erba' ġimgħat).
English: Olanzapine has been authorised in the European Union (EU) since 1996.
Maltese: L-olanzapina ilha awtorizzata fl-Unjoni Ewropea (UE) mill-1996.
English: Zypadhera is a medicine that contains the active substance olanzapine.
Maltese: Zypadhera huwa mediċina li fiha s-sustanza attiva olanzapina.
English: This is a summary of the European public assessment report (EPAR) for Zypadhera.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Zypadhera.
English: It is available as tablets, orodispersible tablets (tablets that dissolve in the mouth) and rapidly acting injections in Zyprexa, Zyprexa Velotab and other medicines.
Maltese: Tiġi bħala pilloli, pilloli orodispersibbli (pilloli li jinħallu fil-ħalq) u f'injezzjonijiet b'azzjoni rapida f'Zyprexa, Zyprexa Velotab u mediċini oħra.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zypadhera on 19 November 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Zypadhera valida fl-Unjoni Ewropea kollha fid-19 ta' Novembru 2008.
English: Symptom scores were around 100 points at the start of the study, but had fallen by around 25 points in the patients receiving Zypadhera after eight weeks, compared with around 9 points in the patients receiving placebo.
Maltese: Ilpunteġġi relatati mas-sintomi kienu madwar 100 punt fil-bidu tal-istudju iżda fil-pazjenti ttrattati b'Zypadhera kienu naqsu b'madwar 25 punt wara tmien ġimgħat, meta mqabbla ma' madwar 9 punti fil-pazjenti ttrattati bil-plaċebo.
English: It is thought that olanzapine's beneficial effect is due to it blocking receptors for the neurotransmitters 5-hydroxytrypamine (also called serotonin) and dopamine.
Maltese: Hu maħsub li l-effett benefiku tal-olanzapina huwa dovut għall-imblokkar tar-riċetturi għan-newrotrażmettituri 5idrossitripamina (5-hydroxytrypamine, imsejħa wkoll serotonina) u dopamina.
English: The most common side effects with Zypadhera (seen in more than 1 patient in 10) are weight gain, somnolence (sleepiness), orthostatic hypotension (sudden drop in blood pressure on standing up) and raised levels of prolactin (a hormone).
Maltese: L-effetti sekondarji l-aktar komuni b'Zypadhera (li dehru f'iktar minn pazjent wieħed minn kull 10) huma żieda fil-piż, somnolenza (ngħas), ipotensjoni ortostatika (il-pressjoni tad-demm titbaxxa f'daqqa mal-qawmien bil-wieqfa) u żieda fil-livelli tal-prolaktin (ormon).
English: • the study of initial treatment compared the effects of three doses of Zypadhera with those of placebo (dummy injections) in 404 patients.
Maltese: • l-istudju fuq it-trattament inizjali qabbel l-effetti ta' tliet dożi ta' Zypadhera ma' dawk ta' plaċebo (injezzjonijiet finti) fuq 404 pazjenti.
English: Symptoms of overdose include sedation (sleepiness) and delirium (confusion).
Maltese: Fost is-sintomi ta' dożaġġ eċċessiv hemm sedazzjoni (ħedla) u delirju (stat ta' konfużjoni).
English: However, patients aged between 65 and 75 years or patients with kidney or liver problems may use Zypadhera if an effective and welltolerated dose of oral olanzapine has been found.
Maltese: Madankollu, il-pazjenti ta' età bejn 65 u 75 sena jew il-pazjenti bi problemi fil-kliewi jew fil-fwied jistgħu jużaw Zypadhera jekk tiġi osservata doża effikaċi u tollerata sew ta' olanzapina mill-ħalq.
English: • the study of maintenance treatment compared the effects of four doses of Zypadhera with those of olanzapine taken by mouth in 1,065 patients.
Maltese: • l-istudju fuq it-trattament ta' żamma qabbel l-effetti ta' erba' dożi ta' Zypadhera ma' dawk talolanzapina meħuda mill-ħalq f'1,065 pazjent.
English: Why has Zypadhera been approved?
Maltese: Għaliex ġie approvat Zypadhera?
English: The ‘high' doses of Zypadhera were more effective at preventing a worsening of symptoms than the ‘low' dose.
Maltese: Id-dożi ‘għoljin' ta' Zypadhera rriżultaw aktar effikaċi fil-prevenzjoni tal-iggravar tas-sintomi meta mqabbla mad-doża ‘baxxa'.
English: Zypadhera has been studied in two main studies involving adults with schizophrenia.
Maltese: Zypadhera ġie eżaminat f'żewġ studji ewlenin li involvew adulti li jbatu minn skiżofrenija.
English: What is Zypadhera?
Maltese: X'inhu Zypadhera?
English: Because olanzapine has already been authorised in the EU as Zyprexa, the company used some of the data from Zyprexa to support the use of Zypadhera.
Maltese: Billi l-olanzapina diġà hija awtorizzata fl-UE bħala Zyprexa, il-kumpanija użat parti mid-dejta dwar Zyprexa biex tappoġġja l-użu ta' Zypadhera.
English: The company that makes Zypadhera will provide an educational programme for doctors, nurses and pharmacists and a card for patients in all Member States, reminding them of how to use the medicine safely.
Maltese: Il-kumpanija li tipproduċi Zypadhera se tipprovdi programm edukattiv għat-tobba, l-infermiera u lispiżjara kif ukoll skeda għall-pazjenti tal-Istati Membri kollha li fiha jitfakkru l-modi ta' użu sikur talmediċina.
English: In the study of the initial treatment of schizophrenia, Zypadhera was more effective than placebo.
Maltese: Fl-istudju fuq it-trattament inizjali tal-iskiżofrenija, Zypadhera rriżulta aktar efficaci mill-plaċebo.
English: In the study looking at the maintenance of response to olanzapine treatment, Zypadhera was as effective as olanzapine taken by mouth: 10% of the patients receiving Zypadhera every two weeks had a worsening of symptoms, compared with 7% of those taking olanzapine by mouth.
Maltese: Fl-istudju fuq iż-żamma tar-rispons għat-trattament b'olanzapina, Zypadhera rriżulta effikaċi daqs lolanzapina meħuda mill-ħalq: 10% tal-pazjenti ttrattati b'Zypadhera kull ġimagħtejn iggravawlhom issintomi meta mqabbla mas-7% ta' dawk ittrattati bl-olanzapina mill-ħalq.
English: Zypadhera is given by deep injection into the buttock muscle by a doctor or nurse who has been trained in giving this type of injection.
Maltese: Zypadhera jingħata b'injezzjoni fonda fil-muskolu tal-gluteu (warrani) minn tabib jew infermier imħarreġ f'dan it-tip ta' injezzjoni.
English: Zypadhera is not recommended for patients over 65 years of age.
Maltese: Zypadhera mhuwiex rakkomandat għall-pazjenti ta' età ‘l fuq minn 65 sena.
English: How has Zypadhera been studied?
Maltese: Kif ġie studjat Zypadhera?
English: For the full list of all side effects reported with Zypadhera, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Zypadhera, ara l-fuljett ta' tagħrif.
English: What is the risk associated with Zypadhera?
Maltese: Għal xiex jintuża Zypadhera?
English: However, it noted that prolonged-release injections are not suitable for use as initial treatment, because the medicine takes at least a week to reduce symptoms and patients may need rapid control of symptoms.
Maltese: Madankollu, innota li l-injezzjonijiet b'rilaxx fit-tul mhumiex adatti bħala trattament inizjali billi t-tnaqqis tas-sintomi ma jibdiex qabel ġimgħa, filwaqt li lpazjent jistgħu jkunu jenħtieġu kontroll rapidu tas-sintomi.
English: The first looked at the initial treatment of schizophrenia and the second looked at the maintenance of response to olanzapine treatment:
Maltese: L-ewwel wieħed eżamina t-trattament inizjali tal-iskiżofrenija filwaqt li t-tieni wieħed eżamina ż-żamma tarrispons għat-trattament bl-olanzapina:
English: It must also not be used in patients at risk of narrow-angle glaucoma (raised pressure inside the eye).
Maltese: Lanqas ma għandu jintuża f'pazjenti li jkollhom riskju ta' glawkoma b'angolu dejjaq (żieda fil-pressjoni fl-għajnejn).
English: In rare cases, patients receiving Zypadhera may experience symptoms of olanzapine overdose after injection if the medicine is accidentally injected into a vein.
Maltese: F'każijiet rari l-pazjenti ttrattati b'Zypadhera jistgħu jesperjenzaw sintomi ta' dożaġġ eċċessiv ta' olanzapina wara l-injezzjoni, jekk ilmediċina tiġi injettata aċċidentalment fil-vina.
English: Other information about Zypadhera
Maltese: Aktar tagħrif dwar Zypadhera
English: Zypadhera is used to maintain the improvement in symptoms in patients with schizophrenia who have already been stabilised on an initial course of olanzapine taken by mouth.
Maltese: Is-CHMP innota li Zypadhera huwa effikaċi kemm fit-trattament inizjali tal-iskiżofrenija kif ukoll fiżżamma ta' rispons għat-trattament fl-iskizofrenija.
English: [Copy-paste from the relevant paragraphs of section (Final assessment conclusions and actions) of the PSUR PRAC AR, with regards to the scientific grounds recommending the variation to the terms of the Marketing Authorisation(s).Avoid the use of abbreviations].
Maltese: [Copy-paste from the relevant paragraphs of section (Final assessment conclusions and actions) of the PSUR PRAC AR, with regards to the scientific grounds recommending the variation to the terms of the Marketing Authorisation(s).
English: Taking into account the PRAC Assessment Report on the PSUR(s) for {name of active substance(s)}, the scientific conclusions of the CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal {sustanza/sustanzi attiva/attivi}, il-konklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: On the basis of the scientific conclusions for {name of active substance(s)} the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing {name of active substance(s)} is unchanged subject to the proposed changes to the product information.
Maltese: Abbażi tal-konklużjonijiet xjentifiċi għal {isem tas-sustanza/sustanzi attiva/attivi} is-CHMP huwa tal-fehma li l-bilanċ bejn il-benefiċċju u r-riskju ta' prodott(i) mediċinali li fih/fihom {isem tas-sustanza/sustanzi attiva/attivi} huwa favorevoli suġġett għall-bidliet proposti għall-informazzjoni tal-prodott.
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS
Maltese: U RAĠUNIJIET GĦALL-VARJAZZJONI GĦAT-TERMINI
English: 16 September 2011
Maltese: 16 Settembru 2011
English: EMA/CHMP/477156/2011 Rev. 1 EMEA/H/A-36/1295
Maltese: EMA/CHMP/477156/2011 Rev.
English: Outcome of a procedure under Article 36 of Directive 2001/83/EC as amended
Maltese: Riżultat ta' proċedura skont l-Artikolu 36 tad-Direttiva 2001/83/KE kif emendata
English: What is Goserelin?
Maltese: X'inhu Goserelin?
English: What are the conclusions of the CHMP?
Maltese: X'kienu l-konklużjonijiet tas-CHMP?
English: The European Medicines Agency has completed a review of the clinical studies that were submitted as part of the marketing authorisation application of the hybrid (a type of generic) medicinal products Novosis Goserelin, Goserelin Cell Pharm, Novimp and associated names (goserelin, 3.6 mg implant).
Maltese: L-Aġenzija Ewropea għall-Mediċini lestiet reviżjoni ta' studji kliniċi li ġew sottomessi bħala parti millapplikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq tal-prodotti mediċinali ibridi (tip ta' prodott mediċinali ġeneriku) Novosis Goserelin, Goserelin Cell Pharm, Novimp u ismijiet assoċjati (goserelin, 3.6 mg impjant).
English: Goserelin is marketed as a hybrid of Zoladex under the names Novimp, Goserelin Cell Pharma, Novosis Goserelin and associated names.
Maltese: Goserelin huwa mqiegħed fis-suq bħala ibridu ta' Zoladex bl-ismijiet Novimp, Goserelin Cell Pharma, Novosis Goserelin u ismijiet assoċjati.
English: Why was Goserelin reviewed?
Maltese: Għalfejn ġie rivedut Goserelin?
English: Goserelin is used to treat patients with advanced prostate cancer.
Maltese: Goserelin jintuża għall-kura ta' pazjenti b'kanċer tal-prostata avvanzat.
English: It is a copy of the natural hormone (luteinizing hormone-releasing hormone) that regulates many processes in the body.
Maltese: Huwa kopja ta' ormon naturali (ormon li jirrillaxxa l-ormon lutinizzanti) li jirregola ħafna proċessi fil-ġisem.
English: The German medicines regulatory agency considered that a suspension of the marketing authorisation of the already authorised medicines was necessary as therapeutic equivalence with the reference medicinal product could not be guaranteed.
Maltese: tal-awtorizzazzjoni għat-tqegħid fis-suq tal-mediċini diġà awtorizzati kienet meħtieġa minħabba li lekwivalenza terapewtika mal-prodott mediċinali ta' referenza ma kinitx iggarantita.
English: Following an inspection, the German medicines regulatory agency found that the clinical studies performed as part of the marketing authorisation applications for some goserelin containing medicines were not conducted in accordance with Good Clinical Practice (GCP) and questioned whether their results could be relied on.
Maltese: Wara spezzjoni, l-aġenzija regolatorja tal-mediċini Ġermaniża sabet li l-istudji kliniċi li kienu saru bħala parti mill-applikazzjonijiet għall-awtorizzazzjoni għat-tqegħid fis-suq għal xi mediċini li fihom ilgoserelin ma sarux skont Prattika Klinika Tajba (GCP) u ddubitat kemm ir-riżultati tagħhom humia ta' min wieħed joqgħod fuqhom.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that these medicines have not be shown to be equivalent to the reference medicine (Zoladex) and therefore the marketing authorisation should be suspended until therapeutic equivalence has been demonstrated.
Maltese: Il-Kumitat tal-Aġenzija għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li ma ntweriex li dawn il-mediċini huma ekwivalenti għall-mediċina ta' referenza (Zoladex) u li għalhekk l-awtorizzazzjoni għat-tqegħid fis-suq għandha tkun sospiża sakemm tintwera ekwivalenza terapewtika.
English: • The risk of serious infections, including opportunistic bacterial, viral and fungal infections in patients treated with Cimzia,
Maltese: • Ir-riskju ta' infezzjonijiet serji, inkluż infezzjonjiet batterjali, virali u fungali opportunistiċi f'pazjenti li huma trattati b' Cimzia,
English: • The contraindication of Cimzia in patients with history of moderate to severe heart failure (NYHA III/IV), and potential risk of congestive heart failure being worsened by Cimzia,
Maltese: • IL-kontraindikazzjonijiet ta' Cimzia f'pazjenti b'storja ta' insuffiċjenza tal-qalb moderata għal severa (NYHA II/IV), u ir-riskju potenzjali li tiggrava l-insuffiċjenza tal-qalb konġestiva b'Cimzia,
English: • Patient Alert Card
Maltese: • Informazzjoni għat-tobba
English: • The risk of acute injection-related reactions and delayed serious systemic hypersensitivity reactions, the need for instructing patients on techniques for administration, and guidance for Health Care Professionals on how to report administration errors,
Maltese: • Ir-riskju ta' reazzjonijiet akuti relatati mal-injezzjoni u reazzjonijiet serji u sistemiċi ta' sensittivita` eccessiva, il-bżonn li tgħallem il-pazjenti dwar it-teknika ta' teħid, u gwida għall-Professjonisti tal-Kura tas-Saħħa dwar kif tirraporta żbalji fit-teħid,
English: • The Summary of Product Characteristics
Maltese: • Sommarju tal- Karatteristiċi tal-Prodott