FrancophonIA/ELRC3.0 huggingface dataset:
English: If the LVEF has declined as indicated in section 4.2 and has not improved, or has declined further at the subsequent assessment, discontinuation of Perjeta and trastuzumab should be strongly considered, unless the benefits for the individual patient are deemed to outweigh the risks.
Maltese: Jekk l-LVEF jonqos kif indikat fis-sezzjoni 4.2 u ma jitjiebx, jew ikompli jonqos fl-evalwazzjoni sussegwenti, twaqqif ta' Perjeta u trastuzumab għandu jiġi kkunsidrat bis-serjetà, sakemm il-benefiċċji għall-pazjent individwali ma jkunux meqjusa akbar mir-riskji.
English: The incidence of symptomatic LVD (congestive heart failure) was 1.3% in the group treated with Perjeta plus trastuzumab and docetaxel following FEC (this excludes a patient who experienced symptomatic LVD
Maltese: L-inċidenza ta' LVD sintomatika (insuffiċjenza konġestiva tal-qalb) kienet ta' 1.3% fil-grupp ikkurat b'Perjeta flimkien ma' trastuzumab u docetaxel wara FEC (dan jeskludi pazjenta li kellha LVD sintomatika waqt kura b'FEC qabel ma rċiviet Perjeta flimkien ma' trastuzumab u docetaxel) u wkoll 1.3% fil-grupp ikkurat b'Perjeta flimkien ma' TCH.
English: Pertuzumab exposure was reported in offspring from all treated groups, at levels of 29% to 40% of maternal serum levels at
Maltese: Esponiment għal pertuzumab kien irrappurtat fil-frieħ mill-gruppi kkurati kollha, f'livelli ta' 29% sa 40% tal-livelli fisserum tal-omm f'GD100.
English: In patients receiving an anthracycline-based regimen, Perjeta and trastuzumab should be administered following completion of the entire anthracycline regimen (see section 4.4).
Maltese: F'pazjenti li jirċievu kors ibbażat fuq anthracycline, Perjeta u trastuzumab għandhom jingħataw wara t-tlestija tal-kors sħiħ ta' anthracycline (ara sezzjoni 4.4).
English: Constipation
Maltese: Sirdat
English: Paronychia Upper respiratory tract infection
Maltese: Newtropenija bid-deni* Newtropenija Lewkopenija Anemija
English: Alternatively, docetaxel can be given at 100 mg/m2 on a 3 weekly schedule from the start, again depending on the chosen regimen.
Maltese: Alternattivament, docetaxel jista' jingħata b'doża ta' 100 mg/m fuq skeda ta' 3 ġimgħat mill-bidu, ukoll skont il-kors ta' dożaġġ magħżul.
English: In BERENICE, 4.1% (16/392) of the patients treated with Perjeta tested positive for ADA.
Maltese: F'BERENICE, 4.1% (16/392) tal-pazjenti kkurati b'Perjeta kellhom riżultat pożittiv għal ADA. Lebda wieħed minn dawn il-pazjenti ma kellu reazzjonijiet anafilattiċi/ta' sensittività eċċessiva li kienu relatati b'mod ċar ma' ADA.
English: When administered with Perjeta in the adjuvant setting, the recommended dose of paclitaxel is 80 mg/m2 once weekly for 12 weekly cycles.
Maltese: Meta jingħata ma' Perjeta f'ambjent adjuvant, id-doża rakkomandata ta' paclitaxel hija ta' 80 mg/m darba fil-ġimgħa għal 12-il ċiklu ta'
English: • a drop in LVEF to less than 50% associated with a fall of ≥ 10% points below pre-treatment values.
Maltese: • tnaqqis fl-LVEF għal inqas minn 50% assoċjat ma' tnaqqis ta' > 10% punti taħt il-valuri ta'
English: Patients should have a pre-treatment LVEF of ≥ 55% (≥ 50% after completion of the anthracycline component of chemotherapy, if given).
Maltese: Il-pazjenti għandu jkollhom LVEF qabel it-trattament ta' ≥ 55% (≥ 50% wara li jitlesta l-komponent ta' anthracycline tal-kimoterapija, jekk jingħata).
English: The majority of rash events were Grade 1 or 2.
Maltese: Il-maġġoranza tal-avvenimenti ta' raxx kienu ta' Grad 1 jew 2.
English: Symptoms may include kidney problems (weakness, shortness of breath, fatigue and confusion), heart problems (fluttering of the heart of a faster or slower heartbeat), seizures, vomiting or diarrhoea and tingling in the mouth, hands or feet
Maltese: Is-sintomi jistgħu jinkludu problemi fil-kliewi (dgħjufija, qtugħ ta' nifs, għeja u konfużjoni), problemi fil-qalb (rata mhux normali tal-qalb li tista' tikkonsisti minn taħbit tal-qalb aktar mgħaġġel jew aktar bil-mod), aċċessjonijiet, rimettar jew dijarea u tingiż fil-ħalq, fl-idejn jew fis-saqajn
English: Anaphylactic reaction°,
Maltese: Reazzjoni anafilattika°,
English: NAME OF THE MEDICINAL PRODUCT Perjeta 420 mg concentrate for solution for infusion
Maltese: Perjeta 420 mg konċentrat għal soluzzjoni għall-infużjoni
English: Neutropenia
Maltese: Kontraċezzjoni
English: The application was withdrawn at ‘day 120'.
Maltese: L-applikazzjoni ġiet irtirata fil-‘jum 120'.
English: What is Docetaxel Mylan?
Maltese: X'inhu Docetaxel Mylan?
English: Withdrawal of the marketing authorisation application for Docetaxel Mylan (docetaxel) EMA/166011/2010
Maltese: Irtirar tal-applikazzjoni għat-tqegħid fis-suq għal Docetaxel Mylan (docetaxel) EMA/352879/2010
English: Docetaxel Mylan is a medicine that contains the active substance docetaxel.
Maltese: Docetaxel Mylan huwa mediċina li fiha s-sustanza attiva docetaxel.
English: The active substance in Docetaxel Mylan, docetaxel, belongs to the group of anticancer medicines known as the taxanes.
Maltese: Is-sustanza attiva f'Docetaxel Mylan, docetaxel, tappartjeni għall-grupp ta' mediċini kontra l-kanċer msejħin taxanes.
English: Withdrawal of the marketing authorisation application for Docetaxel Mylan (docetaxel)
Maltese: Irtirar tal-applikazzjoni għat-tqegħid fis-suq għal Docetaxel Mylan (docetaxel)
English: This means that the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Maltese: Dan ifisser li s-CHMP ivvaluta d-dokumentazzjoni inizjali pprovduta mill-kumpanija u fformula lista ta' mistoqsijiet.
English: Docetaxel Mylan was developed as a ‘generic medicine'.
Maltese: Docetaxel Mylan ġie żviluppat bħala ‘mediċina ġenerika'.
English: Docetaxel blocks the ability of cells to destroy the internal ‘skeleton' that allows them to divide and multiply.
Maltese: Docetaxel jimblokka l-abbiltà taċ-ċelloli li jeqirdu l-‘iskeletru' intern li jippermettilhom jinqasmu u jimmultiplikaw.
English: Docetaxel Mylan was expected to be used to treat breast cancer, non-small-cell lung cancer, prostate cancer, gastric adenocarcinoma (a type of stomach cancer) and head and neck cancer.
Maltese: Docetaxel Mylan kien mistenni li jintuża biex jikkura kanċer tas-sider, kanċer tal-pulmun b'ċelloli mhux żgħar, kanċer tal-prostata, adenokarċinoma gastrika u kanċer tar-ras u tal-għonq.
English: officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Docetaxel Mylan intended to be used to treat breast cancer, non-small-cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.
Maltese: Fit-8 ta' Marzu 2010, Mylan S.A.S. innotifikat uffiċjalment lill-Kumitat għal Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni tagħha għal awtorizzazzjoni għat-tqegħid fis-suq għal Docetaxel Mylan maħsub sabiex jintuża fil-kura ta' kanċer tas-sider, kanċer tal-pulmun b'ċelloli mhux żgħar, kanċer tal-prostata, adenokarċinoma gastrika u kanċer tar-ras u tal-għonq.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Docetaxel Mylan could not have been approved.
Maltese: Skont ir-reviżjoni tad-dejta, fil-ħin tal-irtirar, is-CHMP kellu xi tħassib u kien tal-opinjoni provviżorja li Docetaxel Mylan ma setax jiġi approvat.
English: Because Docetaxel Mylan contains the same active substance as Taxotere and was to be given directly into a vein, the company did not consider additional studies on the Docetaxel Mylan to be necessary according to EU rules.
Maltese: Minħabba li Docetaxel Mylan fih l-istess sustanza attiva bħal Taxotere u kellu jingħata direttament fil-vina, il-kumpanija ma qisitx li studji addizzjonali dwar Docetaxel Mylan huma neċessarji skont ir-regoli tal-UE.
English: What was Docetaxel Mylan expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża Docetaxel Mylan?
English: For more information on generic medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini ġeneriċi, ara d-dokument ta' mistoqsija-u-tweġiba hawnhekk.
English: Because of this and the complex nature of micelles themselves, the Committee had concluded that additional studies on Docetaxel Mylan were necessary, including studies on how the medicine would be treated by the body and its safety.
Maltese: Minħabba dan u minħabba n-natura kumplessa tal-miċelli nfushom, il-Kumitat ikkonkluda li kien hemm bżonn ta' studji addizzjonali fuq Docetaxel Mylan, inkluż studji dwar kif il-mediċina tiġi ttrattata mill-ġisem u s-sigurtà tagħha.
English: This means that Docetaxel Mylan was intended to be similar to a ‘reference medicine' already authorised in the European Union called Taxotere.
Maltese: Dan ifisser li Docetaxel Mylan kien maħsub sabiex ikun simili għal 'mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea imsejħa Taxotere.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom26 September 2014
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom26 ta' Settembru 2014
English: The full European Public Assessment Report for Javlor 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: What is Javlor?
Maltese: X'inhu Javlor?
English: Refusal of a change to the marketing authorisation for Javlor (vinflunine) EMA/587197/2014
Maltese: Rifjut ta' bidla fl-awtorizzazjoni għat-tqegħid fis-suq ta' Javlor (vinflunine) EMA/587197/2014
English: The company that applied for the change to the authorisation is Pierre Fabre Médicament.
Maltese: Il-kumpanija li applikat għall-bidla fl-awtorizzazzjoni kienet Pierre Fabre Médicament.
English: Compared with patients given capecitabine alone, more patients receiving Javlor plus capecitabine experienced side effects including neutropenia (abnormally low blood levels of white blood cells), gastrointestinal events such as constipation, nausea and vomiting and stomach ache, fatigue and nervous system disorders such as damage to the nerves in the extremities.
Maltese: Meta mqabbel ma' pazjenti li ngħataw capecitabine waħdu, iktar pazjenti li rċevew Javlor flimkien ma' capecitabine esperjenzaw effetti sekondarji inklużi newtropenija (livelli baxxi mhux normali ta' ċelloli tad-demm bojod fid-demm), avvenimenti gastrointestinali bħal stitikezza, dardir u rimettar u uġigħ ta' żaqq, għeja u disturbi fissistema nervuża bħal ħsara lin-nervituri fl-estremitajiet.
English: Javlor contains the active substance vinflunine and is available as a concentrate for solution for infusion (drip) into a vein.
Maltese: Javlor fih is-sustanza attiva vinflunine u huwa disponibbli bħala konċentrat għal soluzzjoni għal infużjoni (dripp) fil-vina.
English: The active substance in Javlor, vinflunine, belongs to the group of cancer medicines known as ‘vinca alkaloids'.
Maltese: Is-sustanza attiva f'Javlor, vinflunine, tagħmel parti minn grupp ta' mediċini kontra l-kanċer magħrufin bħala ‘vinca alkaloids'.
English: On 25 September 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a change to the marketing authorisation for the medicinal product Javlor.
Maltese: Fil-25 ta' Settembru 2014, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, fejn irrakkomanda r-rifjut ta' bidla fl-awtorizzazjoni għat-tqegħid fis-suq għallprodott mediċinali Javlor.
English: It may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.
Maltese: Hija tista' titlob eżaminazzjoni mill-ġdid tal-opinjoni fi żmien 15-il ġurnata minn meta tirċievi notifikazzjoni ta' din lopinjoni negattiva.
English: What was Javlor expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Javlor?
English: Javlor was also expected to be used in combination with the cancer medicine capecitabine for the treatment of adult patients with locally advanced or metastatic breast cancer.
Maltese: Javlor kien mistenni wkoll li jintuża flimkien mal-mediċina kontra l-kanċer capecitabine għall-kura ta' pazjenti adulti b'kanċer tas-sider lokalment avvanzat jew metastatiku.
English: It is already used to treat adults with advanced or metastatic ‘transitional-cell carcinoma of the urothelial tract' (a cancer that affects the lining of the bladder and the rest of the urinary tract).
Maltese: Diġà tintuża għall-kura ta' adulti b'‘karċinoma taċ-ċelloli transitorji tal-passaġġ uroteljali' (kanċer li jaffettwa r-rita tal-bużżieqa tal-awrina u l-bqija tal-passaġġ urinarju) avvanzat u metastatiku. ‘Metastatiku' tfisser li l-kanċer infirex għal partijiet oħrajn tal-ġisem.
English: Javlor is a cancer medicine that has been authorised in the EU since September 2009.
Maltese: Javlor huwa mediċina tal-kanċer li ilha awtorizzata fl-UE minn Settembru 2009.
English: How is Javlor expected to work?
Maltese: Kif inhu mistenni li jaħdem Javlor?
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Javlor.
Maltese: Il-kumpanija infurmat lis-CHMP li ma hemm ebda konsegwenza għal pazjenti li bħalissa huma inklużi fi provi kliniċi b'Javlor.
English: The company presented the results of a main study involving 770 patients with advanced breast cancer previously treated with or resistant to an anthracycline and who are taxane resistant.
Maltese: Il-kumpanija pprovdiet ir-riżultati ta' studju ewlieni li involva 770 pazjent b'kanċer tas-sider avvanzat li kienu ġew ikkurati qabel bi jew li huma reżistenti għal anthracycline u li huma reżistenti għal taxane.
English: It attaches to a cell protein called tubulin, which is important in the formation of the internal ‘skeleton' that cells need to allow them to divide.
Maltese: Hija teħel ma' proteina taċ-ċellola msejħa tubulin, li hija importanti filformazzjoni tal-‘iskeletru' intern li ċ-ċelloli għandom bżonn biex ikunu jistgħu jiddividu ruħhom.
English: The CHMP noted that the effectiveness of Javlor in combination with capecitabine had not been sufficiently demonstrated.
Maltese: Is-CHMP innota li l-effikaċja ta' Javlor flimkien ma' capecitabine ma ntweritx b'mod suffiċjenti.
English: EMA/156994/2016 EMEA/H/C/001144
Maltese: EMA/156994/2016 EMA/H/C/001144
English: The European Commission granted a marketing authorisation valid throughout the EU for DuoCover on 15 March 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal DuoCover fil15 ta' Marzu 2010.
English: 1 Previously known as DuoCover.
Maltese: 1 Preċedentement magħruf bħala DuoCover.
English: This summary was last updated in 03-2016.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'03-2016.
English: The full EPAR for Clopidogrel/Acetylsalicylic acid Zentiva 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 most common side effects with Clopidogrel/Acetylsalicylic acid Zentiva (seen in between 1 and 10 patients in 100) are haematoma (a collection of blood under the skin), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), diarrhoea, abdominal pain (stomach ache), dyspepsia (heartburn), bruising, and bleeding where the skin is punctured.
Maltese: L-effetti sekondarji l-aktar komuni ta' Clopidogrel/Acetylsalicylic acid Zentiva (li dehru f'bejn 1 u 10 pazjenti minn kull 100) huma ematoma (ġbir ta' demm taħt il-ġilda), epistassi (fġir tal-imnieħer), emorraġija gastrointestinali (ħruġ ta' demm fiż-żaqq jew fil-musrana), dijarrea, uġigħ addominali (uġigħ fl-istonku), dispepsija (indiġestjoni), tbenġil u ħruġ ta' demm minn fejn il-ġilda tkun ittaqqbet.
English: It is available as tablets containing 75 mg clopidogrel, either with 75 mg or 100 mg acetylsalicylic acid.
Maltese: Jiġi f'pilloli li jkun fihom 75 mg klopidogrel, flimkien ma' jew 75 mg jew 100 mg ta' aċidu aċetilsaliċiliku.
English: The name of the medicine was changed to Clopidogrel/Acetylsalicylic acid Zentiva on 15 January 2016.
Maltese: L-isem tal-mediċina inbidel u sar Clopidogrel/Acetylsalicylic acid Zentiva fil-15 ta' Jannar 2016.
English: This reduces the production of a substance called thromboxane, which normally helps clots to form by attaching platelets together.
Maltese: Dan inaqqas il-produzzjoni ta' sustanza msejħa trombossanu, li normalment tgħin fil-formazzjoni tal-emboli billi tgħaqqad il-pjastrini flimkien.
English: Clopidogrel/Acetylsalicylic acid Zentiva clopidogrel / acetylsalicylic acid
Maltese: Clopidogrel/Acetylsalicylic acid Zentiva1
English: • patients who have unstable angina (a severe type of chest pain) or who have had a heart attack with no ‘ST-segment elevation' (an abnormal reading on the ECG or electrocardiogram), including those who are having a stent (a short tube) inserted into an artery to prevent it from closing up;
Maltese: • pazjenti li jkollhom anġina instabbli (tip ta' uġigħ sever fis-sider) jew kellhom attakk tal-qalb b'ebda ‘elevazzjoni tas-segment ST' (qari anormali fuq l-ECG jew elettrokardjogramma), inklużi dawk li qegħdin ikollhom stent (tubu qasir) inserit fl-arterja biex jipprevjeniha milli tagħlaq;
English: Other information about Clopidogrel/Acetylsalicylic acid Zentiva:
Maltese: Informazzjoni oħra dwar Clopidogrel/Acetylsalicylic acid Zentiva:
English: Clopidogrel/Acetylsalicylic acid Zentiva must not be used in people who are hypersensitive (allergic) to clopidogrel, non steroidal anti-inflammatory drugs (such as acetylsalicylic acid) or any of the other ingredients in Clopidogrel/Acetylsalicylic acid Zentiva.
Maltese: Clopidogrel/Acetylsalicylic acid Zentiva ma għandux jintuża minn persuni li huma ipersensittivi (allerġiċi) għall-klopidogrel, għal mediċini antiinfjammatorji mhux sterojdi (bħall-aċidu aċetilsaliċiliku) jew għal kwalunkwe ingredjent ieħor ta' Clopidogrel/Acetylsalicylic acid Zentiva.
English: It can be used in the following groups of patients who have a condition known as ‘acute coronary syndrome':
Maltese: Jintuża fil-gruppi ta' pazjenti li ġejjin li jkollhom kundizzjoni magħrufa bħala ‘sindromu koronarju akut':
English: Clopidogrel/Acetylsalicylic acid Zentiva is a medicine that contains two active substances, clopidogrel and acetylsalicylic acid (also known as aspirin).
Maltese: Clopidogrel/Acetylsalicylic acid Zentiva huwa mediċina li fiha żewġ sustanzi attivi, il-klopidogrel u laċidu aċetilsaliċiliku (magħruf ukoll bħala aspirina).
English: This document is a summary of the European Public Assessment Report (EPAR) for Clopidogrel/Acetylsalicylic acid Zentiva.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Clopidogrel/Acetylsalicylic acid Zentiva.
English: Acetylsalicylic acid stops the platelets sticking together by blocking an enzyme called prostaglandin cyclo-oxygenase.
Maltese: L-aċidu aċetilsaliċiliku jwaqqaf il-pjastrini milli jeħlu flimkien billi jimblokka enzima msejħa prostaglandina ciklo-oksiġenażi.
English: Clopidogrel/Acetylsalicylic acid Zentiva is used to prevent problems caused by blood clots, such as a heart attack, in adults who are already taking both clopidogrel and acetylsalicylic acid as separate tablets.
Maltese: Clopidogrel/Acetylsalicylic acid Zentiva jintuża biex jipprevjeni problemi kkawżati minn emboli taddemm, bħal attakki tal-qalb, f'adulti li diġà qegħdin jieħdu kemm il-klopidogrel kif ukoll l-aċidu aċetilsaliċiliku bħala pilloli separati.
English: The CHMP noted that Clopidogrel/Acetylsalicylic acid Zentiva is comparable to clopidogrel and acetylsalicylic acid tablets taken separately, and concluded that combining both active substances in a single Clopidogrel/Acetylsalicylic acid Zentiva tablet simplifies treatment for patients as they will need to take fewer tablets.
Maltese: Is-CHMP innota li Clopidogrel/Acetylsalicylic acid Zentiva huwa kumparabbli mal-pilloli tal-klopidogrel u tal-aċidu aċetilsaliċiliku meħuda b'mod separat, u kkonkluda li l-kombinazzjoni taż-żewġ sustanzi flimkien f'pillola waħda ta' Clopidogrel/Acetylsalicylic acid Zentiva tissimplifika l-kura għall-pazjenti peress li jkollhom jieħdu inqas pilloli.
English: What is Clopidogrel/Acetylsalicylic acid Zentiva?
Maltese: Kid ġie studjat Clopidogrel/Acetylsalicylic acid Zentiva?
English: It must not be used in patients who have severely reduced liver or kidney function, or who have a medical condition that includes a combination of asthma, rhinitis (stuffy and runny nose) and nasal polyps (growths in the lining of the nose).
Maltese: Lanqas ma għandu jintuża fuq pazjenti bi tnaqqis gravi fil-funzjoni tal-fwied jew tal-kliewi, jew li jkollhom kundizzjoni medika li tinkludi taħlita ta' ażma, rinite (imnieħer miżdud) u polipi nażali (forom li jitrabbew fir-rita tal-imnieħer).
English: It also presented the results of 3 previous studies involving over 61,000 patients with unstable angina or who had had a heart attack.
Maltese: Ippreżentat ukoll ir-riżultati ta' 3 studji preċedenti li kienu jinvolvu aktar minn 61,000 pazjenti b'anġina instabbli jew li kellhom attakk tal-qalb.
English: What is the risk associated with Clopidogrel/Acetylsalicylic acid Zentiva?
Maltese: X'inhuma r-riskji assoċjati ma' Clopidogrel/Acetylsalicylic acid Zentiva?
English: Clopidogrel/Acetylsalicylic acid Zentiva was shown to be comparable to clopidogrel and acetylsalicylic acid taken separately, and can therefore be used in place of the clopidogrel and acetylsalicylic acid tablets that the patients have already been taking.
Maltese: Clopidogrel/Acetylsalicylic acid Zentiva jittieħed bħala pillola waħda darba kuljum minflok il-pilloli talklopidogrel u tal-aċidu aċetilsaliċiliku li l-pazjenti jkunu diġà qed jieħu b'mod separat.
English: Both active substances in Clopidogrel/Acetylsalicylic acid Zentiva, clopidogrel and acetylsalicylic acid, are antiplatelet medicines.
Maltese: Iż-żewġ sustanzi attivi fi Clopidogrel/Acetylsalicylic acid Zentiva, il-klopidogrel u l-aċidu aċetilsaliċiliku, huma mediċini kontra l-pjastrini.
English: How is Clopidogrel/Acetylsalicylic acid Zentiva used?
Maltese: Kif jintuża Clopidogrel/Acetylsalicylic acid Zentiva?
English: The full EPAR for Clopidogrel Zentiva can be found on the Agency's: website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal Clopidogrel Zentiva jinstab fis-sit elettroniku tal-Aġenzija: website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Clopidogrel Zentiva clopidogrel
Maltese: Clopidogrel Zentiva klopidogrel
English: This corresponds to a relative reduction in risk of 9% compared with aspirin.
Maltese: Dan jikkorrispondi għal tnaqqis relattiv fir-riskju ta' 9% apparagun mal-aspirina.
English: In CAPRIE, there were 939 events in the Clopidogrel Zentiva group, and 1,020 in the aspirin group.
Maltese: Fl-istudju CAPRIE kien hemm 939 każ fil-grupp ta' Clopidogrel Zentiva u 1,020 fil-grupp tal-aspirina.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Clopidogrel Winthrop on 16 July 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Clopidogrel Winthrop fis-16 ta' Lulju 2008.
English: The most common side effects with Clopidogrel Zentiva (seen in between 1 and 10 patients in 100) are haematoma (a collection of blood under the skin), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), diarrhoea, abdominal pain (stomach ache), dyspepsia (heartburn), bruising and bleeding where the skin is punctured.
Maltese: L-effetti sekondarji l-iżjed komuni ta' Clopidogrel Zentiva (li dehru f'bejn 1 u 10 pazjenti minn kull 100) huma ematoma (ġbir ta' demm taħt il-ġilda), epistassi (fsid tal-imnieħer), emorraġija gastrointestinali (ħruġ ta' demm fiż-żaqq jew fil-musrana), dijarrea, uġigħ addominali (fiż-żaqq), dispepsija (indiġestjoni), tbenġil u ħruġ ta' demm minn fejn il-ġilda tkun ittaqqbet.