FrancophonIA/ELRC3.0 huggingface dataset:
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.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Clopidogrel HCS, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: This document is a summary of the European Public Assessment Report (EPAR) for Clopidogrel Teva Pharma.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Clopidogrel HCS.
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.
Danish: Den fuldstændige EPAR for Clopidogrel ratiopharm findes på agenturets websted: EMA website/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel HCS on 21 September 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Clopidogrel HCS den 28. oktober 2010.
English: • recently had a myocardial infarction (heart attack).
Danish: • patienter, som for nylig har haft myokardieinfarkt (hjerteanfald).
English: The standard dose of Clopidogrel Teva Pharma is one 75-mg tablet once a day.
Danish: Standarddosis af Clopidogrel HCS er én tablet a 75 mg én gang dagligt.
English: This means that Clopidogrel Teva Pharma is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Danish: Det betyder, at Clopidogrel HCS er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union, og som hedder Plavix.
English: • peripheral arterial disease (problems with blood flow in the arteries);
Danish: • patienter med perifere kredsløbsforstyrrelser (problemer med blodgennemstrømningen i arterierne)
English: Clopidogrel Teva Pharma can be started between a few days and 35 days after the attack;
Danish: Behandling med Clopidogrel HCS kan påbegyndes mellem få dage og 35 dage efter anfaldet
English: It is used in those patients who have at least one risk factor for vascular events such as a heart attack or stroke, cannot take vitamin K antagonists (other medicines that prevent blood clots) and are at low risk of bleeding.
Danish: Det anvendes til patienter, som har mindst én risikofaktor for hændelser såsom hjerteanfald eller slagtilfælde, som ikke kan tage vitamin K-antagonister (andre lægemidler, der forebygger blodpropper), og som har en lille blødningsrisiko.
English: • atrial fibrillation (irregular rapid contractions of the upper chambers of the heart), when it should be given with aspirin.
Danish: • patienter med atrieflimren (uregelmæssige hurtige sammentrækninger af de øverste hjertekamre), hvor det bør gives sammen med aspirin.
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.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Clopidogrel HCS er af sammenlignelig kvalitet og er bioækvivalent med Plavix.
English: What are the benefit and risk of Clopidogrel Teva Pharma?
Danish: Hvilke fordele og risici er der forbundet med Clopidogrel HCS?
English: Clopidogrel Teva Pharma can be started between seven days and six months after the stroke;
Danish: Behandling med Clopidogrel HCS kan påbegyndes mellem syv dage og seks måneder efter slagtilfældet
English: • recently had an ischaemic stroke (stroke caused by failure of the blood supply to part of the brain).
Danish: • patienter, som for nylig har haft et iskæmisk slagtilfælde (et slagtilfælde, som skyldes manglende blodforsyning til en del af hjernen).
English: In acute coronary syndrome, treatment generally starts with a loading dose of four 75-mg tablets.
Danish: Ved akut koronart syndrom indledes behandlingen normalt med en startdosis på fire tabletter.
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.
Danish: Da Clopidogrel HCS er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Clopidogrel Teva Pharma is used to prevent problems caused by blood clots in adults who have:
Danish: Clopidogrel HCS anvendes til forebyggelse af problemer forårsaget af blodpropper hos voksne.
English: Clopidogrel Teva Pharma is a ‘generic medicine'.
Danish: Clopidogrel HCS er et "generisk lægemiddel".
English: Clopidogrel Teva Pharma is a medicine that contains the active substance clopidogrel.
Danish: Clopidogrel HCS er et blodfortyndende lægemiddel, der indeholder det aktive stof clopidogrel.
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.
Danish: Da Clopidogrel HCS er et generisk lægemiddel, har personundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Plavix.
English: The active substance in Clopidogrel Teva Pharma, clopidogrel, is an inhibitor of platelet aggregation.
Danish: Det aktive stof i Clopidogrel HCS, clopidogrel, er et blodpladeaggregationshæmmende middel.
English: Why has Clopidogrel Teva Pharma been approved?
Danish: Hvorfor blev Clopidogrel HCS godkendt?
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.
Danish: Ved akut koronart syndrom og atrieflimren anvendes Clopidogrel HCS sammen med aspirin.
English: The Committee recommended that Clopidogrel Teva Pharma be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Clopidogrel HCS.
English: 1 Previously known as Clopidogrel HCS.
Danish: Clopidogrel HCS
English: • a condition known as ‘acute coronary syndrome', when it should be given with aspirin (another medicine that prevents blood clots).
Danish: • patienter, der lider af akut koronarsyndrom (nedsat blodforsyning til hjertet), hvor det bør gives sammen med aspirin (et andet lægemiddel, som forebygger blodpropper), herunder patienter, der har fået indsat en stent (et kort rør, der anbringes i arterien for at forhindre den i at tillukkes).
English: How has Clopidogrel Teva Pharma been studied?
Danish: Hvordan blev Clopidogrel HCS undersøgt?
English: Other information about Clopidogrel Teva Pharma:
Danish: Andre oplysninger om Clopidogrel HCS
English: Clopidogrel Teva Pharma clopidogrel
Danish: clopidogrel
English: What is Clopidogrel Teva Pharma used for?
Danish: Hvad anvendes Clopidogrel HCS til?
English: What is Clopidogrel Teva Pharma?
Danish: Hvad er Clopidogrel HCS?
English: How is Clopidogrel Teva Pharma used?
Danish: Hvordan anvendes 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).
Danish: Det kan også anvendes til patienter uden en sådan unormal visning på elektrokardiogrammet, hvis de har ustabil angina (en alvorlig form for brystsmerter) eller har haft myokardieinfarkt uden forekomst af Q-takker
English: How does Clopidogrel Teva Pharma work?
Danish: Hvordan virker Clopidogrel HCS?
English: Patients should be carefully monitored during treatment for the emergence of possible serious and opportunistic infections.
Danish: Patienterne skal nøje overvåges i løbet af behandlingen for eventuelle alvorlige og opportunistiske infektioner.
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.
Danish: Alvorlige infektioner såsom lungebetændelse, stafylokokbakteriæmi, sepsis/septisk chok, (herunder tilfælde med letal udgang) og herpes zoster, Cytomegalovirus (CMV) (reaktivering) og opportunistiske infektioner, f.eks. Pneumocystis jiroveci-pneumoni og oral candidiasis, er blevet indberettet hos patienter behandlet med brentuximab vedotin.
English: Brentuximab vedotin - Cytomegalovirus (CMV) reactivation (EPITT no 18789)
Danish: Brentuximab vedotin - Reaktivering af Cytomegalovirus (CMV) (EPITT nr. 18789)
English: Adopted at the 2-5 May 2017 PRAC
Danish: Vedtaget på PRAC's møde 2.-5. maj 2017
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/252868/2017
Danish: Ny ordlyd af produktinformation - uddrag af PRAC's anbefalinger vedrørende signaler EMA/PRAC/306029/2017
English: Uncommon side effects (affects less than 1 in 100 people) - new or recurring cytomegalovirus (CMV) infection
Danish: Ikke almindelige (forekommer hos færre end 1 ud af 100) - Nye eller tilbagevendende cytomegalovirusinfektioner (CMV)
English: Frequency ‘uncommon': Cytomegalovirus infection or reactivation
Danish: Infektioner og parasitære sygdomme Hyppighed "Ikke almindelig": Cytomegalovirusinfektion eller reaktivering
English: Undesirable effects
Danish: Produktresumé
English: From a microbiological point of view, the product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt bør produktet anvendes straks.
English: You might have any of these symptoms and/or conditions.
Danish: Du vil muligvis kunne opleve nogle af disse symptomer og/eller tilstande.
English: Not known: frequency cannot be estimated from the available data
Danish: Ikke kendt: hyppigheden kan ikke vurderes ud fra forhåndenværende data
English: You should usually receive your infusion once every 3 weeks.
Danish: Du vil normalt få infusionen én gang hver tredje uge.
English: • Thirst and increased water consumption
Danish: Tørst og øget vandforbrug
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC: {number}
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA PC: {number}
English: - if you have recently received or are about to receive a vaccine against yellow fever.
Danish: - hvis du for nylig er blevet eller snart skal vaccineres mod gul feber.
English: Read all of this leaflet carefully before you start receiving this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, før du begynder at bruge dette lægemiddel, da den indeholder vigtige oplysninger.
English: Be careful when driving a car or using machines.
Danish: Vær derfor forsigtig, hvis du kører bil eller betjener maskiner.
English: You must contact your doctor immediately if you notice any of the following:
Danish: Du skal omgående kontakte din læge, hvis du mærker nogle af følgende bivirkninger:
English: Your doctor will use this body surface area to work out the right dose for you.
Danish: Din læge vil bruge dette mål på overfladeareal til at bestemme den rette dosis til dig.
English: The doctor or hospital pharmacist will work out the dose you need based on your height and weight.
Danish: Lægen eller hospitalsfarmaceuten beregner den nødvendige dosis ud fra din højde og vægt.
English: 1526 Ljubljana Slovenia
Danish: 1526 Ljubljana Slovenien
English: Frequency estimate: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from available data).
Danish: Hyppighed: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Based on the planned date of your infusion of Pemetrexed Sandoz and/or on the status of your kidney function, your doctor needs to advise you on which medicines you can take and when you can take them.
Danish: Ud fra den planlagte dato for din infusion af Pemetrexed Sandoz og/eller status for din nyrefunktion skal din læge fortælle dig, hvilke typer medicin du må tage, og hvornår du må tage dem.
English: Pemetrexed total systemic exposure (AUC) and maximum plasma concentration increase proportionally with dose.
Danish: Pemetrexeds samlede systemiske eksponering (AUC) og maksimale plasma- koncentration er proportionalt stigende med dosis.
English: Between-patient variability in clearance is moderate at 19.3 %.
Danish: Der er en moderat variation i clearance blandt patienterne på 19,3 %.
English: The 1 year and 2 year survival rates for patients on pemetrexed were 58% and 32% respectively, compared to 45% and 21% for patients on placebo.
Danish: Den 1-årige og 2- årige overlevelsesrate for patienterne i behandling med pemetrexed var henholdsvis 58 % og 32 % sammenlignet med 45 % og 21 % for patienterne i placebo-behandling.
English: In vitro studies indicate that pemetrexed is actively secreted by OAT3 (organic anion transporter).
Danish: In vitro-studier indikerer, at pemetrexed udskilles ved aktiv sekretion via OAT3 (organisk anion-transporter).
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution / dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis det ikke anvendes straks, er opbevaringstiden- og betingelserne ved brug brugerens ansvar, og vil normalt ikke være mere end 24 timer ved 2-8° C, med mindre rekonstitution/fortyndingen er udført under kontrollerede og validerede aseptiske betingelser.
English: Do not use this medicine if you notice particles or a discolouration.
Danish: Brug ikke dette lægemiddel, hvis der observeres partikler eller misfarvning.
English: Elderly: In clinical studies, there has been no indication that patients 65 years of age or older are at increased risk of adverse events compared to patients younger than 65 years old.
Danish: Ældre: Der er i kliniske studier ikke fundet tegn på, at patienter på 65 år eller ældre har forøget risiko for bivirkninger sammenlignet med patienter under 65 år.
English: If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor.
Danish: Hvis du er gravid, har mistanke om, at du er gravid eller planlægger at blive gravid, skal du fortælle det til din læge.
English: Randomised and treated patients Fully supplemented patients
Danish: Randomiseret og behandlet Patienter
English: Your doctor will discuss with you the potential risk of taking Pemetrexed Sandoz during pregnancy.
Danish: Din læge vil sammen med dig drøfte den potentielle risiko ved at tage Pemetrexed Sandoz under graviditet.
English: The resulting solution is clear and ranges in colour from colourless to pale yellow without adversely affecting product quality.
Danish: Opløsningen bliver derefter klar og kan variere i farve fra farveløs til lysegul, uden at det har negativ indflydelse på produktets kvalitet.
English: Do not use Pemetrexed Sandoz: - if you are allergic (hypersensitive) to pemetrexed or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Pemetrexed Sandoz: - hvis du er overfølsom (allergisk) over for pemetrexed eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: Pack of 1 vial with protective plastic overwrap.
Danish: Pakning med 1 hætteglas med beskytttende plastik-indpakning.
English: a Statistically significant for non-inferiority, with the entire confidence interval for HR well below the 1.17645 non-inferiority margin (p < 0.001).
Danish: a Statistisk signifikans for non-inferiøritet med hele konfidensintervallet for HR pænt under 1,17645 for non- inferiøritet-margin (p <0,001).
English: Very common Anorexia
Danish: Meget almindelig Anoreksi
English: This medicine is given to you to reduce the frequency and severity of skin reactions that you may experience during your anticancer treatment.
Danish: Du får dette lægemiddel for at reducere hyppigheden og sværhedsgraden af eventuelle hudreaktioner, som du kan opleve under kræftbehandlingen.
English: Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after the infusion of Pemetrexed Sandoz has finished.
Danish: Cisplatin indgives også ved infusion i en af dine blodårer, cirka 30 minutter efter at infusionen med Pemetrexed Sandoz er afsluttet.
English: The European Medicines Agency has waived the obligation to submit the results of studies with pemetrexed in all subsets of the paediatric population in the granted indications (see section 4.2).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med pemetrexed i alle undergrupper af den pædiatriske population for de godkendte indikationer (se pkt
English: The efficacy analyses using PQ population are consistent with the analyses for the ITT population and support the non-inferiority of AC versus GC.
Danish: Effektalyser med brug af PQ-populationen er konsistente med analyser for ITTpopulationen og understøtter non- inferiøriteten af AC mod GC.
English: There are no data from the use of pemetrexed in pregnant women; but pemetrexed, like other antimetabolites, is suspected to cause serious birth defects when administered during pregnancy.
Danish: Der er ingen data fra anvendelse af pemetrexed til gravide kvinder, men ligesom andre anti-metabolitter formodes pemetrexed at kunne forårsage alvorlige misdannelser, hvis det indgives under graviditeten.
English: Pemetrexed Sandoz has minor influence on the ability to drive and use machines as it has been reported that pemetrexed may cause fatigue.
Danish: Pemetrexed Sandoz kan have en mindre virkning af evnen til at køre bil eller betjene maskiner, da det er blevet rapporteret, at pemetrexed kan forårsage træthed.
English: Upon recovery, patients should be re-treated using the guidelines in Tables 1, 2, and 3, which are applicable for Pemetrexed Sandoz used as a single agent or in combination with cisplatin.
Danish: Efter rekonvalescens skal patienter efterbehandles ud fra retningslinjerne i tabel 1, 2 og 3, der gælder for brug af Pemetrexed Sandoz som enkeltstof eller i kombination med cisplatin.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald herfra bør bortskaffes i overensstemmelse med lokale krav.
English: You will always receive Pemetrexed Sandoz by infusion into one of your veins.
Danish: Du vil altid få Pemetrexed Sandoz ved infusion i en af dine blodårer.
English: In the event of neurotoxicity, the recommended dose adjustment for Pemetrexed Sandoz and cisplatin is documented in Table 3.
Danish: I tilfælde af neurotoksicitet er den anbefalede dosisjustering for Pemetrexed Sandoz og cisplatin angivet i tabel 3.
English: If you would like to father a child during the treatment or in the 6 months following receipt of treatment, seek advice from your doctor or pharmacist.
Danish: Hvis du ønsker at gøre en kvinde gravid under behandlingsforløbet, eller tidligere end 6 måneder efter behandlingen er stoppet, skal du søge vejledning hos din læge eller hos apotekspersonalet.
English: Your doctor may decide to change the dose or delay treating you depending on your general condition and if your blood cell counts are too low.
Danish: Din læge kan beslutte at ændre dosen eller udskyde behandlingen, afhængigt af din generelle tilstand, og hvis dine blodtal er for lave.
English: Results from in vitro studies with human liver microsomes indicated that pemetrexed would not be predicted to cause clinically significant inhibition of the metabolic clearance of drugs metabolised by CYP3A, CYP2D6, CYP2C9, and CYP1A2.
Danish: Resultaterne af in vitro-forsøg med humane leverrmikrosomer tyder på, at pemetrexed ikke burde forårsage en klinisk signifikant inhibition af den metaboliske clearance af lægemidler, der metaboliseres af CYP3A, CYP2D6, CYP2C9 og CYP1A2.
English: It is not known whether pemetrexed is excreted in human milk, and adverse reactions on the suckling child cannot be excluded.
Danish: Det er ukendt, om pemetrexed udskilles i modermælk, og en påvirkning af ammede børn kan ikke udelukkes.
English: After reconstitution and infusion:
Danish: Efter rekonsitution og infusion
English: At the time of this final survival analysis, 28.7% of patients were alive or lost to follow up on the pemetrexed arm versus 21.7% on the placebo arm.
Danish: På tidspunktet for den endelige analyse af den totale overlevelse var 28,7 % af patienterne i pemetrexed-armen i live eller kunne ikke følges op versus 21,7 % i placebo-armen.
English: Pharmacotherapeutic group: Antineoplastic agents, folic acid analogues, ATC code: L01BA04
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, Folsyreanaloger, ATC-kode L01BA04
English: Use aseptic technique during the reconstitution and further dilution of pemetrexed for intravenous infusion administration.
Danish: Anvend aseptisk teknik ved rekonstituering og yderligere fortynding af pemetrexed til intravenøs infusion.
English: Vitamin B12 and folic acid are given to you to reduce the possible toxic effects of the anticancer treatment.
Danish: Du får B12-vitamin og folsyre for at mindske risikoen for mulige toksiske virkninger af kræftbehandlingen.
English: Efficacy and safety were measured from the time of randomisation after completion of first-line (induction) therapy.
Danish: Virkning og sikkerhed blev målt fra randomiseringstidspunktet efter fuldførelse af 1. linje-behandlingen (induktionsbehandlingen).
English: Therefore, patients should be cautioned against driving or operating machines if this event occurs.
Danish: Patienten skal derfor advares mod at køre bil eller betjene maskiner, hvis han/hun oplever træthed.
English: If you are also receiving cisplatin, your doctor will make sure that you are properly hydrated and receive appropriate treatment before and after receiving cisplatin to prevent vomiting.
Danish: Hvis du også får cisplatin, vil din læge kontrollere, at du får tilstrækkelig med væske og får den rette behandling før og efter indgivelse af cisplatin for at forebygge opkastning.
English: **In the pemetrexed/cisplatin arm, randomised and treated (N=225) and fully supplemented (N=167).
Danish: ** I pemetrexed/cisplatin-armen, randomiseret og behandlet (n = 225) og fuldt tilskud (n = 167)
English: This dose may be adjusted, or treatment may be delayed depending on your blood cell counts and on your general condition.
Danish: Denne dosis skal muligvis justeres, eller behandlingen skal udskydes, afhængigt af dit blodtal og generelle tilstand.
English: Before each infusion you will have samples of your blood taken to evaluate if you have sufficient kidney and liver function and to check that you have enough blood cells to receive Pemetrexed Sandoz.
Danish: Før hver indgivelse vil du få taget blodprøver til vurdering af, om din nyre- og leverfunktion er tilstrækkelig god, og for at kontrollere, om du har blodlegemer nok til at få Pemetrexed Sandoz.
English: Prior to each chemotherapy administration, blood chemistry tests should be collected to evaluate renal and hepatic function.
Danish: Inden hver administration af kemoterapi skal der indsamles laboratorieanalyser af blodet til evaluering af nyre- og leverfunktion.
English: These differences were likely due to differences in the patient population, since the Phase 2 studies included both chemonaive and heavily pre-treated breast cancer patients with pre-existing liver metastases and/or abnormal baseline liver function tests.
Danish: Disse forskelle skyldtes sandsynligvis forskelle i patientpopulationen, eftersom fase 2-studierne både omfattede patienter, som ikke tidligere havde modtaget kemoterapi, og intensivt forbehandlede brystcancer- patienter med eksisterende levermetastaser og/eller unormale leverfunktionsanalyser ved baseline.