FrancophonIA/ELRC3.0 huggingface dataset:
English: • Need for periodic blood counts and dose adjustment
Lithuanian: • Perspėjimas dėl periodinio kraujo ląstelių kiekio nustatymo ir dozės koregavimo;
English: • Management of adverse drug reactions
Lithuanian: • Informacija apie nepageidaujamų vaisto reakcijų gydymą
English: The MAH must implement this educational plan nationally, prior to marketing, and as agreed with the competent authorities in the Member States
Lithuanian: Prieš pateikdamas šį preparatą kiekvienos valstybės narės rinkai, rinkodaros teisės turėtojas turi suderinti mokomosios medžiagos turinį ir formatą su nacionaline kompetentingąja institucija.
English: • Growth follow-up of treated children
Lithuanian: • Perspėjimas dėl tolesnio gydymo kursą gavusių vaikų augimo stebėjimo;
English: • Need for periodic blood counts
Lithuanian: • Perspėjimas dėl periodinio kraujo ląstelių kiekio nustatymo;
English: • Treatment guide for physicians
Lithuanian: • Gydymo vadovas gydytojui;
English: • Package leaflet
Lithuanian: • Pakuotės lapelis;
English: • Risk of medication error due to the availability of two different strengths The patient information pack should contain the following key elements:
Lithuanian: Paciento informacijos rinkinyje turi būti nurodyti šie pagrindiniai dalykai:
English: This summary was last updated in 02-2016.
Lithuanian: Ši santrauka paskutinį kartą atnaujinta 2015-06.
English: The full EPAR for Clopidogrel Teva Pharma can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Lithuanian: Išsamų Clopidogrel HCS EPAR rasite agentūros interneto svetainėje adresu: EMA website/Find medicine/Human medicines/European Public Assessment Reports.
English: • recently had a myocardial infarction (heart attack).
Lithuanian: • neseniai miokardo infarktą (širdies smūgį) patyrusiems pacientams.
English: The standard dose of Clopidogrel Teva Pharma is one 75-mg tablet once a day.
Lithuanian: Standartinė Clopidogrel HCS dozė yra viena 75 mg tabletė kartą per parą.
English: For more information about treatment with Clopidogrel Teva Pharma, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Lithuanian: Daugiau informacijos apie gydymą Clopidogrel HCS rasite pakuotės lapelyje (taip pat EPAR dalis) arba teiraukitės savo gydytojo ar vaistininko.
English: This is then followed by the standard 75-mg dose once a day for at least four weeks (in ‘ST-segment-elevation' myocardial infarction) or for up to 12 months (in unstable angina or ‘non-Q-wave' myocardial infarction).
Lithuanian: Po to gydymas tęsiamas skiriant standartinę 75 mg kartą per parą dozę mažiausiai keturias savaites (miokardo infarkto su ST segmento pakilimu atveju) arba iki 12 mėnesių (nestabilios anginos arba miokardo infarkto be Q bangos atveju).
English: This means that Clopidogrel Teva Pharma is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Lithuanian: Tai reiškia, kad jis panašus į referencinį vaistą Plavix, kurio rinkodaros leidimas Europos Sąjungoje (ES) jau suteiktas.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Clopidogrel Teva Pharma.
Lithuanian: Jame paaiškinama, kaip Žmonėms skirtų vaistinių preparatų komitetas (CHMP) įvertinęs vaistą priėmė nuomonę, kuria rekomenduoja suteikti Clopidogrel HCS rinkodaros leidimą ir pateikia jo vartojimo rekomendacijas.
English: The CHMP concluded that, in accordance with EU requirements, Clopidogrel Teva Pharma has been shown to have comparable quality and to be bioequivalent to Plavix.
Lithuanian: CHMP nusprendė, kad pagal ES reikalavimus įrodyta, jog Clopidogrel HCS yra panašios kokybės kaip Plavix ir yra jam biologiškai ekvivalentiškas.
English: In acute coronary syndrome and atrial fibrillation, Clopidogrel Teva Pharma is used together with aspirin, the dose of which should not be higher than 100 mg.
Lithuanian: Ūminiu vainikinių arterijų sindromu ir prieširdžių virpėjimu sergantiems pacientams Clopidogrel HCS skiriama kartu su aspirinu, kurio dozė negali būti didesnė kaip 100 mg.
English: Because Clopidogrel Teva Pharma is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine's.
Lithuanian: Kadangi Clopidogrel HCS yra generinis vaistas ir įrodytas jo biologinis ekvivalentiškumas referenciniam vaistui, manoma, kad jo nauda ir rizika yra tokia pat kaip ir referencinio vaisto.
English: Clopidogrel Teva Pharma can be started between a few days and 35 days after the attack;
Lithuanian: Clopidogrel HCS galima pradėti gerti praėjus kelioms dienoms, bet ne daugiau kaip 35 dienoms po širdies smūgio;
English: This document is a summary of the European Public Assessment Report (EPAR) for Clopidogrel Teva Pharma.
Lithuanian: Šis dokumentas yra Clopidogrel HCS Europos viešo vertinimo protokolo (EPAR) santrauka.
English: • peripheral arterial disease (problems with blood flow in the arteries);
Lithuanian: • pacientams, sergantiems periferinių arterijų liga (kurių kraujotaka arterijomis sutrikusi);
English: • recently had an ischaemic stroke (stroke caused by failure of the blood supply to part of the brain).
Lithuanian: • neseniai išeminį insultą (smūgį, kuris ištiko nutrūkus dalies smegenų aprūpinimui krauju) patyrusiems pacientams.
English: • atrial fibrillation (irregular rapid contractions of the upper chambers of the heart), when it should be given with aspirin.
Lithuanian: • pacientams, kurie serga prieširdžių virpėjimu (nereguliarūs greiti viršutinių širdies kamerų susitraukimai), kartu su aspirinu.
English: What are the benefit and risk of Clopidogrel Teva Pharma?
Lithuanian: Kokia yra Clopidogrel HCS nauda ir rizika?
English: Clopidogrel Teva Pharma is used to prevent problems caused by blood clots in adults who have:
Lithuanian: Clopidogrel HCS skiriamas siekiant išvengti kraujo krešulių sukeliamų problemų suaugusiems pacientams.
English: Why has Clopidogrel Teva Pharma been approved?
Lithuanian: Kodėl Clopidogrel HCS buvo patvirtintas?
English: The Committee recommended that Clopidogrel Teva Pharma be given marketing authorisation.
Lithuanian: Komitetas rekomendavo suteikti Clopidogrel HCS rinkodaros leidimą.
English: Because Clopidogrel Teva Pharma is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Lithuanian: Kadangi Clopidogrel HCS yra generinis vaistas, su žmonėmis atlikti tik tyrimai, skirti jo biologiniam ekvivalentiškumui referenciniam vaistui Plavix įrodyti.
English: Clopidogrel Teva Pharma can be started between seven days and six months after the stroke;
Lithuanian: Clopidogrel HCS galima pradėti gerti praėjus ne mažiau kaip septynioms dienoms ir ne daugiau kaip šešiems mėnesiams po insulto;
English: The active substance in Clopidogrel Teva Pharma, clopidogrel, is an inhibitor of platelet aggregation.
Lithuanian: Clopidogrel HCS veiklioji medžiaga klopidogrelis yra trombocitų agregacijos inhibitorius.
English: Clopidogrel Teva Pharma is a medicine that contains the active substance clopidogrel.
Lithuanian: Clopidogrel HCS - tai kraują skystinantis vaistas, kurio sudėtyje yra veikliosios medžiagos klopidogrelio.
English: In acute coronary syndrome, treatment generally starts with a loading dose of four 75-mg tablets.
Lithuanian: Ūminiu vaininkinių arterijų sindromu sergantiems pacientams gydymas paprastai pradedamas įsotinamąja keturių tablečių doze.
English: 1 Previously known as Clopidogrel HCS.
Lithuanian: Kita informacija apie Clopidogrel HCS
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel HCS on 21 September 2009.
Lithuanian: suteikė visoje Europos Sąjungoje galiojantį Clopidogrel HCS rinkodaros leidimą.
English: Clopidogrel Teva Pharma is a ‘generic medicine'.
Lithuanian: Clopidogrel HCS yra generinis vaistas.
English: • a condition known as ‘acute coronary syndrome', when it should be given with aspirin (another medicine that prevents blood clots).
Lithuanian: • pacientams, kuriems diagnozuotas vadinamasis ūminis vainikinių arterijų sindromas (liga, kai sutrinka širdies aprūpinimas krauju), kartu su aspirinu (kitu kraujo krešuliams susidaryti neleidžiančiu vaistu), taip pat pacientams, kuriems įstatytas stentas (į arteriją įvestas trumpas vamzdelis, neleidžiantis arterijai užsikimšti).
English: How has Clopidogrel Teva Pharma been studied?
Lithuanian: Kaip buvo tiriamas Clopidogrel HCS?
English: How does Clopidogrel Teva Pharma work?
Lithuanian: Kaip veikia Clopidogrel HCS?
English: How is Clopidogrel Teva Pharma used?
Lithuanian: Kaip vartoti Clopidogrel HCS?
English: Acute coronary syndrome is a group of heart problems that include heart attacks and unstable angina (a severe type of chest pain).
Lithuanian: Vaistą galima vartoti ir kai nėra EKG pakitimų, jei pacientui pasireiškia nestabilioji krūtinės angina (stiprus skausmas krūtinės srityje) ar yra ištikęs miokardo infarktas be Q bangos;
English: What is Clopidogrel Teva Pharma used for?
Lithuanian: Kam vartojamas Clopidogrel HCS?
English: What is Clopidogrel Teva Pharma?
Lithuanian: Kas yra Clopidogrel HCS?
English: Clopidogrel Teva Pharma clopidogrel
Lithuanian: Clopidogrel HCS
English: Other information about Clopidogrel Teva Pharma:
Lithuanian: Clopidogrel HCS galima skirti:
English: Serious infections such as pneumonia, staphylococcal bacteraemia, sepsis/septic shock (including fatal outcomes) and herpes zoster, Cytomegalovirus (CMV) (reactivation) and opportunistic infections such as Pneumocystis jiroveci pneumonia and oral candidiasis have been reported in patients treated with brentuximab vedotin.
Lithuanian: Buvo pranešta apie sunkias infekcijas, tokias kaip plaučių uždegimas, stafilokokinė bakteriemija, sepsis ir (arba) sepsinis šokas (taip pat mirtini) ir herpes zoster, citomegaloviruso (CMV) (reaktyvacija) bei oportunistines infekcijas, tokias kaip Pneumocystis jiroveci pneumonija ir burnos kandidozė pacientams, gydomiems brentuksimabo vedotinu.
English: Uncommon side effects (affects less than 1 in 100 people) - new or recurring cytomegalovirus (CMV) infection
Lithuanian: Nedažnas šalutinis poveikis (pasireiškia mažiau nei 1 iš 100 žmonių) - nauja arba pasikartojanti citomegaloviruso (CMV) infekcija.
English: Brentuximab vedotin - Cytomegalovirus (CMV) reactivation (EPITT no 18789)
Lithuanian: Brentuksimabo vedotinas - Citomegaloviruso (CMV) reaktyvacija (EPITT Nr.
English: Frequency ‘uncommon': Cytomegalovirus infection or reactivation
Lithuanian: Dažnis nežinomas: citomegaloviruso infekcija arba reaktyvacija.
English: Adopted at the 2-5 May 2017 PRAC
Lithuanian: gegužės 2-5 d. posėdyje
English: You may need to read it again.
Lithuanian: Potrebbe aver bisogno di leggerlo di nuovo.
English: • At the request of the European Medicines Agency;
Lithuanian: • su richiesta dell'Agenzia europea per i medicinali;
English: From a microbiological point of view, the product should be used immediately.
Lithuanian: Da un punto di vista microbiologico, il prodotto deve essere usato immediatamente.
English: You might have any of these symptoms and/or conditions.
Lithuanian: Lei potrebbe presentare uno di questi sintomi e/o condizioni.
English: You should usually receive your infusion once every 3 weeks.
Lithuanian: Di solito lei deve ricevere l'infusione una volta ogni 3 settimane.
English: DATE OF REVISION OF THE TEXT
Lithuanian: DATA DI REVISIONE DEL TESTO
English: An updated RMP should be submitted:
Lithuanian: Il RMP aggiornato deve essere presentato:
English: If necessary, creatinine clearance should be closely monitored.
Lithuanian: Se necessario, la clearance della creatinina deve essere monitorata attentamente.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Lithuanian: COMPOSIZIONE QUALITATIVA E QUANTITATIVA
English: Not known: frequency cannot be estimated from the available data
Lithuanian: Non nota: la frequenza non può essere definita sulla base dei dati disponibili
English: Treatment may be delayed to allow sufficient time for recovery.
Lithuanian: Il trattamento può essere ritardato per consentire un periodo sufficiente di recupero.
English: The use of gloves is recommended.
Lithuanian: E' raccomandato l'uso dei guanti.
English: The following information is intended for healthcare professionals only:
Lithuanian: Le informazioni seguenti sono destinate esclusivamente agli operatori sanitari:
English: The pH of the reconstituted solution is between 6.6 and 7.8.
Lithuanian: Il pH della soluzione ricostituita è tra 6,6 e 7,8.
English: Further dilution is required.
Lithuanian: E' necessaria un'ulteriore diluizione.
English: Treatment should be resumed according to the guidelines in Table 2.
Lithuanian: Il trattamento deve essere ricominciato secondo le linee guida indicate nella Tabella 2.
English: Calea Floreasca nr. 169A, Cladirea A, etaj 1, sector 1, Bucure ti
Lithuanian: 169A, Cladirea A, etaj 1, sector 1, Bucure ti
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Lithuanian: Questo medicinale non deve essere miscelato con altri medicinali ad eccezione di quelli menzionati nel paragrafo 6.6.
English: This combination should be used with caution.
Lithuanian: Questa associazione deve essere usata con cautela.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Lithuanian: 4.5 Interazioni con altri medicinali ed altre forme d'interazione
English: - Keep this leaflet.
Lithuanian: - Conservi questo foglio.
English: Be careful when driving a car or using machines.
Lithuanian: Faccia attenzione quando guida un veicolo o utilizza macchinari.
English: • Risk Management Plan (RMP)
Lithuanian: • Piano di gestione del rischio (RMP)
English: Read all of this leaflet carefully before you start receiving this medicine because it contains important information for you.
Lithuanian: Legga attentamente questo foglio prima di ricevere questo medicinale perché contiene importanti informazioni per lei.
English: Date of first authorisation: 18 September 2015
Lithuanian: DATA DELLA PRIMA AUTORIZZAZIONE/ RINNOVO DELL'AUTORIZZAZIONE Data della prima autorizzazione:18 Settembre 2015
English: 6.5 Nature and contents of container
Lithuanian: 6.5 Natura e contenuto del contenitore
English: 6.2 Incompatibilities
Lithuanian: 6.2 Incompatibilità
English: Package leaflet: Information for the user
Lithuanian: Foglio illustrativo: informazioni per l'utilizzatore
English: Contraceptive measures or abstinence are recommended.
Lithuanian: Si raccomandano misure contraccettive o l'astinenza.
English: - if you have recently received or are about to receive a vaccine against yellow fever.
Lithuanian: - se è stato sottoposto recentemente o sta per essere sottoposto alla vaccinazione per la febbre gialla.
English: Additional medicines:
Lithuanian: Medicinali aggiuntivi:
English: • Periodic safety update reports
Lithuanian: • Rapporti periodici di aggiornamento sulla sicurezza
English: *Definition of frequency terms: Very common - ≥ 10%; Common - > 5% and < 10%.
Lithuanian: *Definizione della frequenza: Molto comune - ≥ 10%; Comune - > 5% e < 10%.
English: The infusion will last approximately 10 minutes.
Lithuanian: L'infusione durerà circa 10 minuti.
English: There are many sorts of NSAIDs with different durations of activity.
Lithuanian: Ci sono molti tipi di FANS con diversa durata di attività.
English: 4.8 Undesirable effects
Lithuanian: 4.8 Effetti indesiderati
English: ANNEX II
Lithuanian: ALLEGATO II
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Lithuanian: • ogni volta che il sistema di gestione del rischio è modificato, in particolare a seguito del ricevimento di nuove informazioni che possono portare a un cambiamento significativo del profilo beneficio/rischio o al risultato del raggiungimento di un importante obiettivo (di farmacovigilanza o di minimizzazione del rischio).
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Lithuanian: Come tutti i medicinali, questo medicinale può causare effetti indesiderati sebbene non tutte le persone li manifestino.
English: No dose reductions other than those recommended for all patients are necessary.
Lithuanian: Non sono necessarie riduzioni della dose oltre a quelle raccomandate per tutti i pazienti.
English: The doctor or hospital pharmacist will work out the dose you need based on your height and weight.
Lithuanian: Il medico o il farmacista ospedaliero calcolerà la dose di cui ha bisogno in base alla sua altezza e al suo peso.
English: The primary efficacy analysis was based on the ITT population.
Lithuanian: L'analisi primaria di efficacia si basava sulla popolazione ITT.
English: Summary of the safety profile
Lithuanian: Sommario del profilo di sicurezza
English: Infection (sepsis) may be severe and could lead to death.
Lithuanian: L'infezione (sepsi) può essere grave e potrebbe portare alla morte.
English: The resulting solution is clear and ranges in colour from colourless to pale yellow without adversely affecting product quality.
Lithuanian: La soluzione così ottenuta è chiara ed è variabile da incolore a giallo chiaro senza influenzare negativamente la qualità del prodotto.
English: Superiority p-value
Lithuanian: Superiorità p-value
English: Your doctor will use this body surface area to work out the right dose for you.
Lithuanian: Il medico userà questa superficie corporea per calcolare la dose giusta per lei.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Lithuanian: Per ulteriori informazioni su questo medicinale, contatti il rappresentante locale del titolare dell'autorizzazione all'immissione in commercio:
English: Monitoring
Lithuanian: Monitoraggio
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
Lithuanian: CONDIZIONE GENERALE DI FORNITURA Medicinale soggetto a prescrizione medica.
English: Very common
Lithuanian: Molto comune
English: Any diarrhoea requiring hospitalisation (irrespective of grade) or Grade 3 or 4 diarrhoea
Lithuanian: Qualsiasi diarrea che ha richiesto ospedalizzazione (indipendentemente dal grado) o diarrea di grado 3 o 4.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Lithuanian: Agli operatori sanitari è richiesto di segnalare qualsiasi reazione avversa sospetta tramite il sistema nazionale di segnalazione riportato nell'Allegato V.
English: • Thirst and increased water consumption
Lithuanian: ● Sete e aumentato consumo d'acqua
English: Particular attention should be paid to these patients, and caution exercised with use of other radiosensitising agents.
Lithuanian: Deve essere posta particolare attenzione a questi pazienti, così come all'uso di altri agenti radiosensibilizzanti.
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Lithuanian: ALTRA(E) AVVERTENZA(E) PARTICOLARE(I), SE NECESSARIO Citotossico
English: No statistically significant differences in any other individual Grade 3/4/5 adverse reactions were seen with longer exposure.
Lithuanian: Non sono state osservate differenze statisticamente significative in nessuna altra reazione avversa individuale di Grado 3/4/5 con una esposizione più lunga.
English: 4.7 Effects on ability to drive and use machines
Lithuanian: 4.7 Effetti sulla capacità di guidare veicoli e sull'uso di macchinari
English: Female fertility was not investigated.
Lithuanian: L'effetto sulla fertilità femminile non è stato studiato.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Lithuanian: Lei può inoltre segnalare gli effetti indesiderati direttamente tramite il sistema nazionale di segnalazione riportato nell'Allegato V. Segnalando gli effetti indesiderati lei può contribuire a fornire maggiori informazioni sulla sicurezza di questo medicinale.
English: Increases in adverse reactions (all grades) were observed with longer exposure.
Lithuanian: Aumenti delle reazioni avverse (tutti i gradi di tossicità) sono stati osservati con una esposizione più lunga.
English: Your height and weight are measured to work out the surface area of your body.
Lithuanian: La sua altezza e il suo peso vengono misurati per calcolare la sua superficie corporea.
English: The results of these analyses of efficacy are summarised in the table below.
Lithuanian: I risultati di queste analisi di efficacia sono riassunti nella seguente tabella:
English: Read the package leaflet before use.
Lithuanian: Leggere il foglio illustrativo prima dell'uso.
English: PFS data were partially confirmed by an independent review (400/1725 patients were randomly selected for review).
Lithuanian: I dati di PFS sono stati parzialmente confermati da una revisione indipendente (400/1.725 pazienti sono stati selezionati in maniera casuale per la revisione).
English: 4.2 Posology and method of administration
Lithuanian: 4.2 Posologia e modo di somministrazione
English: Rarely, skin reactions may be severe and could lead to death.
Lithuanian: Raramente, le reazioni cutanee possono essere gravi e potrebbero portare alla morte.
English: You must contact your doctor immediately if you notice any of the following:
Lithuanian: Deve immediatamente contattare il medico se nota uno qualsiasi dei seguenti effetti indesiderati:
English: Sensitivity analyses of main efficacy endpoints were also assessed on the Protocol Qualified (PQ) population.
Lithuanian: Anche le analisi di sensibilità dei principali obiettivi di efficacia sono state valutate sulla popolazione Protocol Qualified (PQ).
English: The infusion of cisplatin will last approximately 2 hours.
Lithuanian: L'infusione di cisplatino durerà circa 2 ore.
English: Contents of the pack and other information
Lithuanian: Contenuto della confezione e altre informazioni
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Lithuanian: Medicinale soggetto a prescrizione medica limitativa (vedere allegato I: Riassunto delle Caratteristiche del Prodotto, paragrafo 4.2).
English: Mannitol (E421)
Lithuanian: Mannitolo (E421)
English: 4.6 Fertility, pregnancy and lactation
Lithuanian: 6 Fertilità, gravidanza e allattamento
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Lithuanian: PRECAUZIONI PARTICOLARI PER LO SMALTIMENTO DEL MEDICINALE NON UTILIZZATO O DEI RIFIUTI DERIVATI DA TALE MEDICINALE, SE NECESSARIO
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Lithuanian: All'interno di ciascuna classe di frequenza, gli effetti indesiderati sono riportati in ordine decrescente di gravità.
English: Animal studies have shown reproductive toxicity (see section 5.3).
Lithuanian: Studi su animali hanno dimostrato una tossicità riproduttiva (vedere paragrafo 5.3).
English: The pemetrexed maintenance safety profiles from the two studies JMEN and PARAMOUNT were similar.
Lithuanian: I profili di sicurezza del trattamento di mantenimento con pemetrexed nei due studi JMEN e PARAMOUNT sono risultati essere simili.
English: 5.3 Preclinical safety data
Lithuanian: 5.3 Dati preclinici di sicurezza