FrancophonIA/ELRC3.0 huggingface dataset:
English: Each box contains 28, 56 or
Maltese: Kull kaxxa jkun fiha 28, 56 jew 112-il kapsula.
English: Mean data shown for convenience, categorical analysis performed using van Elteren test ITT: Intent-To-Treat; RDO: Retrieved Drop Outs; LOCF: Last Observation Carried Forward
Maltese: Għall-konvenjenza qed tintwera l-medja tad-dejta, l-analiżi kategorika saret bit-test Elteren ITT: Intenzjoni li jingħata t-trattament;
English: Prometax 4.6 mg/24 h transdermal patch Prometax 9.5 mg/24 h transdermal patch Prometax 13.3 mg/24 h transdermal patch rivastigmine
Maltese: Prometax 9.5 mg/24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda rivastigmine
English: EU/1/98/092/025 60 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/026 90 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/037 60 transdermal patches (sachet: paper/PET/PE/alu/PA) EU/1/98/092/038 90 transdermal patches (sachet: paper/PET/PE/alu/PA)
Maltese: EU/1/98/092/037 60 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda (qartas: karta/PET/PE/alu/PA) EU/1/98/092/038 90 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda (qartas: karta/PET/PE/alu/PA)
English: Absorption of rivastigmine from Prometax transdermal patches is slow.
Maltese: Is-sustanza attiva f'Prometax hija rivastigmine.
English: Clinically relevant improvement in these studies was defined a priori as at least 4-point improvement on the ADAS-Cog, improvement on the CIBIC-Plus, or at least a 10% improvement on the PDS.
Maltese: F'dawn listudji, it-titjib klinikament rilevanti kien definit a priori bħala mill-anqas titjib b'4 punti fl-ADASCog, bħala titjib fis-CIBIC-Plus, jew titjib b'tal-anqas 10% fil-PDS.
English: Off-white to slightly yellow powder in a capsule with yellow cap and yellow body, with red imprint “ENA 713 1,5 mg” on body.
Maltese: Trab offwajt li jagħti ħarira fl-isfar, f'kapsula b'għatu isfar u korp isfar, u stampata bl-aħmar “ENA 713 1.5 mg” fuq il-korp.
English: EU/1/98/092/021 60 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/022 90 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/033 60 transdermal patches (sachet: paper/PET/PE/alu/PA) EU/1/98/092/034 90 transdermal patches (sachet: paper/PET/PE/alu/PA)
Maltese: EU/1/98/092/033 60 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda (qartas: karta/PET/PE/alu/PA) EU/1/98/092/034 90 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda (qartas: karta/PET/PE/alu/PA)
English: • Uneven heart rate (e.g. fast heart rate)
Maltese: • Deidrazzjoni (titlef ħafna ilma)
English: Anxiety, depression, delirium, agitation
Maltese: Ansjetà, depressjoni, thewdin, aġitazzjoni
English: Prometax is used for the treatment of adult patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Maltese: Prometax jintuża għat-trattament ta' pazjenti adulti b'dimenzja ta' Alzheimer minn ħafifa sa moderata, disturb progressiv tal-moħħ li bil-mod il-mod jaffettwa l-memorja, l-ħila intellettwali u l-imġiba.
English: EU/1/98/092/023 7 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/024 30 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/035 7 transdermal patches (sachet: paper/PET/PE/alu/PA) EU/1/98/092/036 30 transdermal patches (sachet: paper/PET/PE/alu/PA)
Maltese: EU/1/98/092/035 7 garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda (qartas: karta/PET/PE/alu/PA) EU/1/98/092/036 30 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda (qartas: karta/PET/PE/alu/PA)
English: Dose titration: Adverse reactions (e.g. hypertension and hallucinations in patients with Alzheimer's dementia and worsening of extrapyramidal symptoms, in particular tremor, in patients with dementia associated with Parkinson's disease) have been observed shortly after dose increase.
Maltese: Ġew osservati reazzjonijiet avversi (eż. pressjoni għolja u alluċinazzjonijiet f'pazjenti b'dimenzja ta' Alzheimer u sintomi ekstrapiramidali marru għall-agħar, l-aktar tregħid, f'pazjenti b'dimenzja assoċjata mal-marda ta' Parkinson) ftit wara li ġiet miżjuda d-doża.
English: Application site skin reactions (usually mild to moderate application site erythema), are the most frequent adverse reactions observed with the use of Prometax transdermal patch.
Maltese: Reazzjonijiet tal-ġilda fis-sit tal-applikazzjoni (normalment eritema minn ħafifa sa moderata fis-sit talapplikazzjoni), huma l-aktar reazzjonijiet avversi frekwenti osservati bl-użu tal-garża Prometax li tipprovdi mediċina li tgħaddi minn ġol-ġilda.
English: • Patients with body weight below 50 kg may experience more adverse reactions and may be more likely to discontinue due to adverse reactions (see section 4.2).
Maltese: • Pazjenti li jkollhom piż taħt il-50 kg jista' jkollhom aktar reazzjonijiet avversi u hemm aktar ċans li jwaqqfuh minħabba r-reazzjonijiet avversi (ara sezzjoni 4.2).
English: Transdermal patch
Maltese: Tregħid
English: • Treatment usually starts with Prometax 4.6 mg/24 h.
Maltese: • Il-kura s-soltu tibda b'Prometax 4.6 mg/24 siegħa.
English: • A patient on a dose of 6 mg/day oral rivastigmine can be switched to 4.6 mg/24 h transdermal patches.
Maltese: • Pazjent fuq doża ta' 6 mg/jum rivastigmine orali jistgħu jinqalbu għal 4.6 mg/24 siegħa garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda.
English: EU/1/98/092/019 7 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/020 30 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/031 7 transdermal patches (sachet: paper/PET/PE/alu/PA) EU/1/98/092/032 30 transdermal patches (sachet: paper/PET/PE/alu/PA)
Maltese: EU/1/98/092/031 7 garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda (qartas: karta/PET/PE/alu/PA) EU/1/98/092/032 30 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda (qartas: karta/PET/PE/alu/PA)
English: Filling the syringe
Maltese: Żieda fid-doża
English: 1 transdermal patch per sachet
Maltese: mixi b'saqajn ikaxkru
English: EU/1/98/092/027 7 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/028 30 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/039 7 transdermal patches (sachet: paper/PET/PE/alu/PA) EU/1/98/092/040 30 transdermal patches (sachet: paper/PET/PE/alu/PA)
Maltese: EU/1/98/092/039 7 garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda (qartas: karta/PET/PE/alu/PA) EU/1/98/092/040 30 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda (qartas: karta/PET/PE/alu/PA)
English: Pruritus, allergic dermatitis (disseminated) General disorders and administration site conditions Common
Maltese: Ħakk, dermatite allerġika (mifruxa)
English: Allergic dermatitis (disseminated) General disorders and administration site conditions Very common
Maltese: Dermatite allerġika (mifruxa)
English: Prometax 4.6 mg/24 h transdermal patch Prometax 9.5 mg/24 h transdermal patch Prometax 13.3 mg/24 h transdermal patch
Maltese: • Pazjent fuq doża ta' 12 mg/24 siegħa rivastigmine orali jista' jinqaleb għal 9.5 mg/24 siegħa garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda.
English: If you are pregnant, the benefits of using Prometax must be assessed against the possible effects on your unborn child. Prometax should not be used during pregnancy unless clearly necessary.
Maltese: Jekk ħriġt tqila, il-benefiċċji ta' Prometax għandhom jiġu evalwati kontra l-effetti li jista' jkun hemm fuq it-tarbija li għadha ma twelditx.
English: - Blister of clear PVC tray with blue lidding foil with 14 capsules.
Maltese: - Folja bi trej ċar tal-PVC bil-wiċċ tal-fojl blu b'14-il kapsula.
English: Rivastigmine is an acetyl- and butyrylcholinesterase inhibitor of the carbamate type, thought to facilitate cholinergic neurotransmission by slowing the degradation of acetylcholine released by functionally intact cholinergic neurones.
Maltese: Pazjenti b'indeboliment epatiku klinikament sinifikanti jista' jkollhom aktar reazzjonijiet avversi dipendenti fuq id-doża.
English: • A patient on a dose of 3 mg/day oral rivastigmine can be switched to 4.6 mg/24 h transdermal patches.
Maltese: • Pazjent fuq doża ta' 3 mg/jum rivastigmine orali jistgħu jinqalbu għal 4.6 mg/24 siegħa garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda.
English: Based on ANCOVA with treatment and country as factors and baseline ADAS-Cog as a covariate.
Maltese: Ibbażat fuq ANCOVA bil-kura u l-pajjiż bħala fatturi u l-linja bażi ADAS-Cog bħala kovarjant.
English: This summary was last updated in 11-2017.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 11-2017.
English: The full EPAR for Zytiga 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 Zytiga
Maltese: Informazzjoni oħra dwar Zytiga
English: This is a summary of the European public assessment report (EPAR) for Zytiga.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Zytiga.
English: Zytiga is available as tablets (250 and 500 mg) and can only be obtained with a prescription.
Maltese: Zytiga jiġi bħala pilloli (250 u 500 mg) u jista' jinkiseb biss b'riċetta ta' tabib.
English: The most common side effects with Zytiga (seen in more than 1 patient in 10) are urinary tract infection, hypokalaemia (low blood potassium levels), high blood pressure, peripheral oedema (swelling of the limbs due to fluid retention) and increases in liver enzymes.
Maltese: L-effetti sekondarji l-aktar komuni b'Zytiga (li dehru f'aktar minn pazjent 1 minn kull 10) kienu infezzjoni fl-apparat urinarju, ipokalemija (livelli baxxi ta' potassju fid-demm), pressjoni tad-demm għolja u edema periferali (nefħa fid--dirgħajn u r-riġlejn minħabba żamma ta' fluwidu) u żieda flenzimi tal-fwied Effetti sekondarji importanti oħra jinkludu problemi fil-qalb, problemi fil-fwied, ksur u alveoliti allerġika (reazzjoni tal-pulmun li tikkawża sogħla u nuqqas ta' nifs).
English: Why is Zytiga approved?
Maltese: Għaliex ġie approvat Zytiga?
English: Zytiga abiraterone acetate
Maltese: Zytiga aċetat tal-abirateron
English: One study involved 1,209 patients with newly diagnosed, high-risk, hormone-sensitive, metastatic prostate cancer.
Maltese: Studju minnhom involva 1,209 pazjenti dijanjostikati ġodda b'kanċer metasatiku fil-prostata, b'riskju għoli u sensittiv għall-ormoni.
English: Zytiga is a medicine used to treat cancer of the prostate (a gland of the male reproductive system) in adult men when the cancer is metastatic (has spread to other parts of the body).
Maltese: Zytiga jintuża fil-kura tal-kanċer tal-prostata (glandola fis-sistema riproduttiva tar-raġel) fi rġiel adulti meta l-kanċer ikun metastatiku (infirex ma' partijiet oħra tal-ġisem).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zytiga on 5 September 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Zytigafil-5 ta' Settembru 2011.
English: Zytiga contains the active substance abiraterone acetate.
Maltese: Zytiga fih is-sustanza attiva aċetat tal-abirateron.
English: What are the risks associated with Zytiga?
Maltese: X'inhuma r-riskji assoċjati ma' Zytiga?
English: • when medical or surgical castration and chemotherapy containing docetaxel have not worked or no longer work.
Maltese: • meta kastrazzjoni medika jew intervent kirurġiku u l-kimoterapija li jkun fihom id-docetaxel ma jkunux ħadmu jew ma baqgħux jaħdmu.
English: • when the cancer is newly diagnosed, high risk and still sensitive to hormones; Zytiga is then used in combination with a treatment called androgen deprivation therapy;
Maltese: • meta l-kanċer ikun dijanjostikat bħala ġdid, b'riskju għoli u jkun għadu sensittiv għall-ormoni; Zytiga jintuża flimkien ma' kura li tissejjaħ terapija ta' deprivazzjoni ta' androġen;
English: The active substance in Zytiga, abiraterone acetate, is changed in the body to abiraterone which stops the body producing testosterone, a male hormone.
Maltese: Is-sustanza attiva f'Zytiga, l-aċetat tal-abirateron, tinbidel fil-ġisem f'abirateron li twaqqaf lill-ġisem milli jipproduċi t-testosteron, ormon maskili.
English: Abiraterone does this by blocking an enzyme called CYP17 found in the testes and elsewhere in the body.
Maltese: L-abirateron tagħmel dan billi timblokka enzima msejħa CYP17 li tinstab fit-testikoli u f'partijiet oħra tal-ġisem.
English: In a third study involving 1,195 men with metastatic prostate cancer whose disease had got worse despite surgical or medical castration treatment and chemotherapy with docetaxel, the main measure of effectiveness was overall survival (how long the patients lived).
Maltese: Fit-tielet studju li involva 1,195 raġel bil-kanċer metastatiku fil-prostata li l-marda tagħhom marret għall-agħar minkejja l-kura ta' kastrazzjoni medika jew kirurġika u kimoterapija b'docetaxel, il-kejl ewlieni tal-effikaċja kien is-sopravivenza globali (kemm għexu l-pazjenti).
English: Zytiga is well tolerated and its risks are considered manageable.
Maltese: Zytiga huwa ttollerat tajjeb u r-riskji tiegħu huma meqjusa maniġġabbli.
English: The recommended dose of Zytiga is 1,000 mg taken once a day at least two hours after eating and at least one hour before further food.
Maltese: Id-doża rakkomandata ta' Zytiga hija 1,000 mg meħuda darba kuljum mill-inqas sagħtejn wara l-ikel u mill-inqas siegħa qabel jittieħed aktar ikel.
English: • when medical castration (using medicines to stop the production of male hormones) with an androgen deprivation therapy has not worked or no longer works in men who have either no symptoms or only mild symptoms of the disease, and who do not yet need chemotherapy (cancer medicines);
Maltese: • meta kastrazzjoni medika (it-twaqqif tal-produzzjoni tal-ormoni maskili fil-ġisem bl-użu ta' mediċini) permezz ta' terapija tad-deprivazzjoni tal-androġen ma tkunx ħadmet jew ma baqgħatx taħdem fi rġiel li, jew ma għandhomx sintomi jew għandhom sintomi ħfief biss tal-marda, u li għad ma għandhomx bżonn tal-kimoterapija (mediċini kontra l-kanċer);
English: Zytiga is used together with the medicines prednisone or prednisolone in the following situations:
Maltese: Zytiga jintuża flimkien mal-mediċini prednisone jew prednisolone fis-sitwazzjonijiet li ġejjin:
English: Because the cancer needs a supply of testosterone to survive and grow, by reducing the production of testosterone, Zytiga may slow the growth of the prostate cancer.
Maltese: Minħabba li l-kanċer jeħtieġ provvista ta' testosteron biex jgħix u jikber, bit-tnaqqis fil-produzzjoni tat-testoteron, Zytiga jista' jittardja t-tkabbir tal-kanċer tal-prostata.
English: Patients treated with Zytiga lived for an average of 33 months without their disease getting worse, compared with around 15 months for patients given placebo.
Maltese: Il-pazjeti kkurati b' Zytiga għexu medja ta' 33-il xahar mingħajr ma lmarda aggravat, meta mqabbla ma' 15-il xahar f'pazjenti li ħadu l-plaċebo.
English: The second study involved 1,088 men with metastatic prostate cancer who had either no symptoms or only mild symptoms of the disease and for whom castration treatment had not worked or had stopped working.
Maltese: It-tieni studju involva 1,088 raġel li kellhom kanċer metastatiku fil-prostata li ma kellhomx sintomi jew kellhom biss sintomi ħfief tal-marda u li għalihom il-kura ta' kastrazzjoni ma ħadmitx jew ma baqgħetx taħdem.
English: For the full list of all side effects reported with Zytiga, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtata b'Zytiga, ara l-fuljett ta' tagħrif.
English: How does Zytiga work?
Maltese: Kif jintuża Zytiga?
English: What measures are being taken to ensure the safe and effective use of Zytiga?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Zytiga?
English: In the studies, patients were also treated with prednisone or prednisolone.
Maltese: Fl-istudji, il-pazjenti ġew ikkurati wkoll bi prednisone jew prednisolone.
English: Patients treated with Zytiga lived for an average of around 16 months without their disease getting worse, compared with around 8 months in patients given placebo.
Maltese: Il-pazjeti li ngħataw Zytiga għexu medja ta' 16-il xahar mingħajr ma l-marda aggravat, meta mqabbla ma' 8 xhur f'pazjenti li ħadu l-plaċebo.
English: Iron sucrose; iron carboxymaltose; iron isomaltoside; iron dextran; sodium ferric gluconate - Arteriospasm coronary (EPITT no 19408)
Maltese: Sukrożju tal-ħadid; karbossimaltożju tal-ħadid; isomaltoside tal-ħadid; dekstran tal-ħadid; glukonat ferriku tas-sodju - Arterjospasma koronarja (EPITT nru 19408)
English: There have been reports of hypersensitivity reactions which progressed to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction, see section 4.8).
Maltese: Kien hemm rapporti ta' reazzjonijiet ta' sensittività eċċessiva li wasslu għas-sindrome ta' Kounis (arterjospasma koronarja allerġika akuta li tista' tirriżulta f'infart mijokardijaku, ara sezzjoni 4.8).
English: Frequency ‘Not known': Kounis syndrome
Maltese: Sindrome ta' Kounis
English: And chest pain which can be a sign of a potentially serious allergic reaction called Kounis syndrome.
Maltese: U wġigħ fis-sider li jista' jkun sinjal ta' reazzjoni allerġika potenzjalment serja msejħa sindrome ta' Kounis.
English: Parenterally administered iron preparations can cause hypersensitivity reactions including serious and potentially fatal anaphylactic/anaphylactoid reactions.
Maltese: Preparazzjonijiet li fihom ħadid li jingħataw b'mod parenterali jistgħu jikkawżaw reazzjonijiet ta' sensittività eċċessiva inkluż reazzjonijiet anafilattiċi/anafilattojdi serji u potenzjalment fatali.
English: Hypersensitivity reactions
Maltese: Reazzjonijiet allerġiċi
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/580133/2019
Maltese: Formulazzjoni ġdida tal-kliem tal-informazzjoni dwar prodott - Siltiet mirrakkomandazzjonijiet tal-PRAC dwar is-sinjali EMA/PRAC/601860/2019
English: Adopted at the 28-31 October 2019 PRAC
Maltese: Adottata fil-PRAC ta' bejn it-28 u l-31 ta' Ottubru 2019
English: Ref. EMEA/CHMP/384875/2008
Maltese: EMEA/CHMP/674028/2008
English: London, 02 December 2008 Doc.
Maltese: Londra, 2 ta' Diċembru 2008 Dok. Ref.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Efexor and associated names International Non-Proprietary Name (INN): venlafaxine
Maltese: GĦALL-UŻU MILL-BNIEDEM (CHMP) OPINJONI WARA REFERENZA SKONT L-ARTIKOLU 30 GĦAL Efexor u ismijiet assoċjati Denominazzjoni Komuni Internazzjonali (DKI): venlafaxine
English: Efexor, 25 mg, 37.5 mg, 50 mg, 75 mg, tablets, is an antidepressant indicated for the treatment of major depressive episodes and for the prevention of recurrence of major depressive episodes.
Maltese: Efexor, disponibbli f'pilloli ta' 25 mg, 37.5 mg, 50 mg u 75 mg, huwa antidepressiv indikat fit-trattament ta' episodji depressivi qawwijin u għall-prevenzjoni ta' rikorrenza ta' episodji depressivi qawwijin. Fit-3 ta' Mejju 2007, il-Kummissjoni Ewropea ppreżentat referenza lill-EMEA skont l-Artikolu 30 tadDirettiva 2001/83/KE, kif emendata, sabiex tarmonizza s-Sommarji tal-Karatteristiċi tal-Prodott (SPC) u tTikketta u l-Fuljett ta' Tagħrif tal-prodott mediċinali Efexor.
English: This medicinal product belongs to the 2007 list of products identified for SPC harmonisation.
Maltese: Dan il-prodott mediċinali jappartjeni għal-lista ta' prodotti tal-2007 li huma identifikati għallarmonizzazzjoni tal-SPC.
English: The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Efexor approved across EU Member States, with respect to the treatment of major depressive episodes and for the prevention of recurrence of major depressive episodes.
Maltese: Ir-referenza kienet ibbażata fuq diverġenzi fis-Sommarji tal-Karatteristiċi tal-Prodott (SPC) ta' Efexor approvati fl-Istati Membri tal-UE, f'dak li għandu x'jaqsam mat-trattament ta' episodji depressivi qawwijin u l-prevenzjoni ta' rikorrenza ta' episodji depressivi qawwijin.
English: The procedure started on 24 May 2007.
Maltese: Il-proċedura bdiet fl-24 ta' Mejju 2007.
English: The CHMP gave a positive opinion on 24 July 2008 with a subsequent revision on 25 September 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet for Efexor.
Maltese: Is-CHMP ta opinjoni pożittiva fl-24 ta' Lulju 2008 b'reviżjoni sussegwenti fil-25 ta' Settembru 2008 li kienet tirrakkomanda l-armonizzazzjoni tal-SPC, it-Tikketta u l-Fuljett ta' Tagħrif għal Efexor.
English: The Marketing Authorisation Holder provided supplementary information on 26 September 2007.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq ipprovda tagħrif supplimentari fis-26 ta' Settembru 2007.
English: During its July 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package Leaflet was acceptable and that they should be amended.
Maltese: Waqt il-laqgħa tiegħu f'Lulju 2008, is-CHMP, fid-dawl tad-dejta kumplessiva mressqa u d-diskussjoni xjentifika li saret fi ħdan il-Kumitat, kien tal-opinjoni li l-proposta għall-armonizzazzjoni tal-SPC, itTikketta u l-Fuljett ta' Tagħrif kienet aċċettabbli u li dawn għandhom jiġu emendati.
English: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, United Kingdom: Plendil
Maltese: L-Awstrija, il-Belġju, il-Bulgarija, il-Kroazja, Ċipru, ir-Repubblika Ċeka, id-Danimarka, l-Estonja, ilFinlandja, il-Greċja, l-Ungerija, l-Islanda, l-Irlanda, l-Italja, il-Latvja, il-Litwanja, il-Lussemburgu, Malta, il-Pajjiżi l-Baxxi, in-Norveġja, il-Polonja, il-Portugall, ir-Rumanija, is-Slovakkja, Spanja, lIsvezja, ir-Renju Unit: Plendil
English: [Plendil 5 mg and 10 mg] Carnauba wax
Maltese: [Plendil 5 mg u 10 mg] Carnauba wax
English: {Name and address} <{tel}> <{fax}> <{e-mail}>
Maltese: {Isem u indirizz} <{tel}> <{fax}> <{e-mail}>
English: Table 1 Undesirable effects System organ class
Maltese: Tabella 1 Effetti mhux mixtieqa Sistema tal-klassifika talorgani
English: {Name and Address} {tel} {fax} {e-mail}
Maltese: {Isem u Indirizz} {tel} {fax} {e-mail}
English: Uncommon ≥ 1/1,000 to < 1/100 Rare ≥ 1/10,000 to < 1/1,000
Maltese: Mhux komuni ≥ 1/1,000 sa <1/100 Rari ≥1/ 10,000 sa <1/1,000
English: Impotence/sexual dysfunction
Maltese: Impotenza/disfunzjoni sesswali
English: Very rare < 1/10,000
Maltese: Rari ħafna < 1/10,000
English: - The active substance felodipine.
Maltese: Is-sustanza attiva hi felodipine.
English: Additional interactions
Maltese: Interazzjonijiet addizzjonali
English: Plendil contains lactose.
Maltese: Plendil fih lactose.
English: Plendil contains lactose and castor oil
Maltese: Plendil fih lactose u castor oil
English: • Palpitations
Maltese: • Palpitazzjonijiet
English: The study showed benefits of lowering SBP and DBP down to 139 and 83 mmHg, respectively.
Maltese: L-istudju wera l-benefiċċji tattnaqqis ta' SBP u DBP sa 139 u 83 mmHg, rispettivament.
English: Arthralgia, myalgia
Maltese: Artralġja, mijalġja
English: Common ≥ 1/100 to < 1/10
Maltese: Komuni ≥ 1/100 sa <1/10
English: Angina pectoris
Maltese: Anġina pectoris
English: A total of 18,790 hypertensive patients (DBP 100-115 mmHg), aged 50-80 years were followed for a mean period of 3.8 years (range 3.3-4.9).
Maltese: Total ta' 18,790 pazjent bi pressjoni għolja (DBP 100-115 mmHg), li kellhom bejn 50 u 80 sena ġew segwiti għal perjodu medju ta' 3.8 snin (medda 3.3-4.9).
English: Germany: Modip Italy: Feloday, Prevex Portugal: Preslow Sweden: Felodipin AstraZeneca
Maltese: Feloday, Prevex Il-Portugall: Preslow L-Isvezja:
English: 4.3 Contraindications
Maltese: 4.3 Kontraindikazzjonijiet • Tqala
English: Carnauba wax Iron oxide yellow (E172) Hypromellose 6 mPa·s Macrogol 6000
Maltese: Kisja tal-pillola Carnauba wax Iron oxide yellow (E172) Hypromellose 6 mPa·s Macrogol 6000