FrancophonIA/ELRC3.0 huggingface dataset:
English: The number of patients experiencing the co-primary endpoint (CV death, MI, stroke or refractory ischaemia) was 1,035 (16.5%) in the clopidogrel-treated group and 1,187 (18.8%) in the placebo-treated group, a 14% relative risk reduction (95% CI of 6%-21%, p=0.0005) for the clopidogrel-treated group.
Danish: Antallet af patienter, som oplevede det primære endpoint [kardiovaskulært dødsfald, myokardieinfarkt, slagtilfælde eller refraktær iskæmi] var 1035 (16,5 %) i clopidogrelgruppen og 1187 (18,8 %) i placebogruppen, hvilket giver en relativ risikoreduktion på 14 % (95 % CI: 6 % - 21 %; p=0,0005) for clopidogrelgruppen.
English: Do not take Clopidogrel Teva Pharma B.V.
Danish: Tag ikke Clopidogrel Teva Pharma B.V.
English: • Omeprazole, esomeprazole or cimetidine, medicines to treat upset stomach.
Danish: • omeprazol, esomeprazol eller cimetidin til behandling af for meget mavesyre
English: + ASA treatment group compared to the placebo + ASA group (1.4% versus 0.8%, respectively).
Danish: Der var flere intrakranielle blødninger i clopidogrel + ASA-gruppen sammenlignet med placebo + ASA-gruppen (1,4% versus 0,8%, henholdsvis).
English: Within each system organ class, adverse drug reactions are presented in order of decreasing seriousness.
Danish: Inden for hver gruppe af bivirkninger med samme frekvens er bivirkningerne opstillet efter, hvor alvorlige bivirkningerne er.
English: The number of patients who reached the primary endpoint (time to first occurrence of stroke, MI, non-CNS systemic embolism or vascular death) was 832 (22.1%) in the group treated with clopidogrel + ASA and 924 (24.4%) in the placebo + ASA group (relative risk reduction of 11.1%; 95% CI of 2.4% to 19.1%; p=0.013), primarily due to a large reduction in the incidence of strokes.
Danish: Antallet af patienter, der nåede det primære endepunkt (tid til første forekomst af apopleksi, MI, nonCNS systemisk emboli eller vaskulær død) var 832 (22,1%) i gruppen behandlet med clopidogrel + ASA og 924 (24,4%) i placebo + ASA-gruppen (relativ risikoreduktion 11,1%; 95% CI 2,4% til 19,1%, p = 0,013).
English: What you need to know before you take Clopidogrel Teva Pharma B.V.
Danish: Det skal du vide, før du begynder at tage Clopidogrel Teva Pharma B.V.
English: Due to the irreversible binding, platelets exposed are affected for the remainder of their lifespan (approximately 7-10 days) and recovery of normal platelet function occurs at a rate consistent with platelet turnover.
Danish: Clopidogrel binder sig irreversibelt til trombocytternes ADP-receptor, hvorfor trombocytaggregationen hæmmes i resten af trombocytternes levetid (ca. 710 dage), og normal trombocytfunktion generhverves med den hastighed, hvormed trombocytterne omsættes.
English: Finnland ratiopharm Oy Sími: +358 20 180 5900
Danish: Sími: +358 20 180 5900.
English: Clopidogrel Teva Pharma B.V. 75 mg film-coated tablets clopidogrel
Danish: 75 mg filmovertrukne tabletter clopidogrel
English: Rare side effects (may affect up to 1 in 1000 people):
Danish: Sjældne bivirkninger (kan påvirke op til 1 ud af 1.000 patienter):
English: • Renal impairment Therapeutic experience is limited in patients with renal impairment (see section 4.4).
Danish: Der er kun begrænset terapautisk erfaring med behandling af patienter med nedsat nyrefunktion (se pkt.
English: Reduced levels of certain white blood cells which increases the risk of infection (neutropenia) Vertigo (dizziness accompanied by a whirling sensation) Bleeding inside the abdomen
Danish: • Reducerede niveauer af visse hvide blodlegemer, hvilket øger risikoen for infektion (neutropeni)
English: If you forget to take Clopidogrel Teva Pharma B.V.
Danish: Hvis du har glemt at tage Clopidogrel Teva Pharma B.V.
English: As a precaution concomitant use of strong or moderate CYP2C19 inhibitors should be discouraged (see sections 4.4 and 5.2).
Danish: Som forholdsregel frarådes samtidig anvendelse af stærke eller intermediate CYP2C19 (se pkt.
English: • Diarrhoea, abdominal pain, indigestion or heartburn
Danish: • Diarré, mavesmerter, fordøjelsesbesvær eller halsbrand.
English: If a dose is missed: - Within less than 12 hours after regular scheduled time: patients should take the dose immediately and then take the next dose at the regular scheduled time.
Danish: − Mindre end 12 timer efter planlagt administration: patienten skal straks tage den glemte dosis og tage den næste dosis som planlagt
English: There was an excess of intracranial bleeding in the clopidogrel
Danish: øget blødning på stedet for et stiksår
English: Headache and dizziness
Danish: Nyrer og urinveje
English: However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 4 ‘Possible Side Effects')
Danish: Hvis du er bekymret over din blødning, skal du omgående kontakte din læge (se pkt.
English: If you forget to take a dose of Clopidogrel Teva Pharma B.V., but remember within 12 hours of the missed dose, take your tablet straight away and then take your next tablet at the usual time.
Danish: til sædvanlig tid, men kommer i tanke om det i løbet af 12 timer, skal du omgående tage tabletten og dernæst tage den næste tablet til sædvanlig tid.
English: Then, the usual dose is one 75-mg tablet of Clopidogrel Teva Pharma B.V. per day
Danish: Derefter er den anbefalede dosis 1 tablet Clopidogrel Teva Pharma B.V.
English: • Bruising, haematoma (unusual bleeding under the skin), nose bleeds, bleeding in the stomach or bowels, increased bleeding at the site of a puncture wound
Danish: • Blå mærker, hæmatom (usædvanlig blødning under huden), næseblod, blødning i mave eller tarm,
English: - Perforated blisters contain 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablet.
Danish: - De perforerede blistere indeholder 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 eller 100x1 filmovertrukket tablet.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Danish: indeholder lactose: Kontakt lægen, før du tager denne medicin, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter
English: • 30 tablets bottle: 30 days
Danish: 30 tabletter i HDPE-flaske: Skal kasseres 30 dage efter åbning
English: • Ticlopidine, other antiplatelet agent.
Danish: • ticlopidin, der er anden medicin mod blodpropper.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING BOTTLE LABEL (30 or 100 film-coated tablets)
Danish: ETIKET PÅ FLASKE (30 eller 100 filmovertrukne tabletter)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablet)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER (14x1, 28x1, 30x1, 50x1, 84x1, 90x1 eller 100x1 filmovertrukket tablet)
English: Other medicines and Clopidogrel Teva Pharma B.V.
Danish: Brug af anden medicin sammen med Clopidogrel Teva Pharma B.V.
English: How to store Clopidogrel Teva Pharma B.V.
Danish: Brug af Clopidogrel Teva Pharma B.V.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Clopidogrel Teva Pharma B.V. 75 mg film-coated tablets clopidogrel oral use
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Clopidogrel Teva Pharma B.V.
English: - Peelable perforated blisters contain 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablet.
Danish: - De perforerede blistere, hvor folien kan trækkes af, indeholder 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 eller 100x1 filmovertrukket tablet.
English: INFORMATION IN BRAILLE Clopidogrel Teva Pharma B.V. 75 mg
Danish: INFORMATION I BRAILLESKRIFT Clopidogrel Teva Pharma B.V.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON of blisters (14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablet)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE med blistere (14x1, 28x1, 30x1, 50x1, 84x1, 90x1 eller 100x1 filmovertrukket tablet)
English: - If you have any side effects, including any side effects not listed in this leaflet, talk your doctor or pharmacist.
Danish: Tal med lægen eller apotekspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke fremgår af denne indlægsseddel.
English: Symptoms may include altered behaviour, headaches, coma, visual disturbances, seizures (fitting), kidney failure, fever, extreme tiredness, weakness, or bleeding into the stomach, bowels or skin (including small red spots or large bruised areas)
Danish: feber, ekstrem træthed, svaghed eller blødning i mave, tarm eller hud (herunder små røde prikker eller store områder med blå mærker)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON of peelable blisters (14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablet)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE med blistere, hvor folien kan trækkes af (14x1, 28x1, 30x1, 50x1, 84x1, 90x1 eller 100x1 filmovertrukket tablet)
English: Teva Pharma - Produtos Farmacêuticos Lda Tel: (351) 21 476 75 50
Danish: Tel: (351) 21 476 75 50
English: How to take Clopidogrel Teva Pharma B.V.
Danish: Sådan skal du tage Clopidogrel Teva Pharma B.V.
English: Ulcers in the stomach and small intestine, nausea, vomiting, constipation, flatulence (wind) and inflammation of the stomach leading to sickness, loss of appetite and discomfort after eating Reduction in blood platelets which makes bleeding or bruising more likely Blood disorders including a reduction in the number of white blood cells which makes infections more likely.
Danish: • Sår i maven og tyndtarmen, kvalme, opkastning, forstoppelse, flatulens (luft i maven) og betændelse i maven, der fører til kvalme, appetitløshed og ubehag efter spisning
English: If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed clopidogrel in combination with acetylsalicylic acid, a substance used to relieve pain and lower fever.
Danish: Hvis du har haft alvorlige smerter i brystet (hjertekrampe (ustabil angina pectoris) eller hjerteanfald), kan din læge ordinere Clopidogrel Teva Pharma B.V.
English: Clopidogrel Teva Pharma B.V. contains lactose.
Danish: Clopidogrel Teva Pharma B.V.
English: Uncommon side effects (may affect up to 1 in 100 people):
Danish: Ikke almindelige bivírkninger (kan påvirke op til 1 ud af 100 patienter):
English: Renal and urinary disorders
Danish: Blod i urinen
English: RoActemra received a marketing authorisation valid throughout the EU on 16 January 2009.
Danish: RoActemra fik en markedsføringstilladelse med gyldighed i hele EU den 16. januar 2009.
English: Further information on RoActemra can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/RoActemra.
Danish: Yderligere information om RoActemra findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/RoActemra.
English: Patients were allowed to continue treatment with methotrexate during the study.
Danish: Patienterne fik lov til at fortsætte behandlingen med methotrexat i løbet af studiet.
English: RoActemra must not be used in patients who have an active, severe infection.
Danish: RoActemra må ikke anvendes til patienter, som har en aktiv, svær infektion.
English: As for all medicines, data on the use of RoActemra are continuously monitored.
Danish: Som for alle lægemidler, er data vedrørende brug af RoActemra løbende overvåget.
English: By preventing interleukin-6 attaching to its receptors, tocilizumab reduces the inflammation and other symptoms of these diseases.
Danish: Ved at forhindre interleukin-6 i at binde sig til sine receptorer reducerer tocilizumab betændelsen og andre symptomer på disse sygdomme.
English: All patients were also treated with a corticosteroid, which was stopped after reducing the dose gradually over 6 or 12 months.
Danish: Alle patienterne blev også behandlet med et kortikosteroid, der blev nedtrappet gradvist over seks eller 12 måneder.
English: What measures are being taken to ensure the safe and effective use of RoActemra?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af RoActemra?
English: The pack will also include a patient alert card with key safety information for patients.
Danish: Informationsmaterialet skal også omfatte et patientkort med de væsentligste sikkerhedsoplysninger.
English: An overview of RoActemra and why it is authorised in the EU
Danish: En oversigt over RoActemra og hvorfor det er godkendt i EU
English: RoActemra is a medicine used to treat:
Danish: RoActemra er et lægemiddel til behandling af:
English: For more information about using RoActemra, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af RoActemra, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Side effects reported with RoActemra are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for RoActemra vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: The European Medicines Agency decided that RoActemra's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved RoActemra opvejer risiciene, og det kan godkendes til anvendelse i EU.
English: Almost 4,000 patients from these 5 studies went on to enter studies looking at the long-term effects of RoActemra treatment and results showed that response to RoActemra is maintained for at least 2 years.
Danish: Næsten 4 000 patienter fra disse fem studier deltog efterfølgende i studier af langtidsvirkningerne af RoActemra, og resultaterne viste, at behandlingsresponsen på RoActemra opretholdtes i mindst 2 år.
English: What is RoActemra and what is it used for?
Danish: Hvad er RoActemra, og hvad anvendes det til?
English: Tocilizumab attaches to the receptor for a messenger molecule or ‘cytokine' called interleukin-6.
Danish: Tocilizumab binder sig til receptoren for et såkaldt cytokin (et signalmolekyle), der hedder interleukin-6.
English: Why is RoActemra authorised in the EU?
Danish: Hvorfor blev RoActemra godkendt i EU?
English: Doctors should monitor patients carefully for signs of infection during treatment, and should prescribe RoActemra with caution in patients who have had recurring or long-term infections, or diseases that could increase the risk of infections, such as diverticulitis or diabetes.
Danish: Lægen bør overvåge patienten nøje for symptomer på infektion under behandlingen og bør ordinere RoActemra med forsigtighed til patienter, som har tilbagevendende eller langvarige infektioner eller sygdomme, som kan øge risikoen for infektioner, såsom divertikulitis (en tarmsygdom) eller diabetes.
English: Studies show RoActemra is effective at reducing symptoms of several inflammatory conditions.
Danish: Studier har vist, at RoActemra er effektivt til at mindske symptomerne ved en række inflammatoriske sygdomme.
English: The most serious side effects are serious infections, complications of diverticulitis (a disease affecting the gut) and hypersensitivity (allergic) reactions.
Danish: De alvorligste bivirkninger er alvorlige infektioner, komplikationer af divertikulitis (sygdom i tarmen) og overfølsomhed (allergiske reaktioner).
English: The company that markets RoActemra must supply all doctors expected to prescribe the medicine with an educational pack containing important information on the safety and correct use of RoActemra.
Danish: Den virksomhed, der markedsfører RoActemra, skal sørge for, at alle læger, som forventes at ordinere lægemidlet, modtager en informationsmateriale med vigtige oplysninger om brugen af og sikkerheden ved RoActemra.
English: RoActemra can only be obtained with a prescription and treatment should be started by a doctor who has experience in the diagnosis and treatment of the relevant condition.
Danish: RoActemra udleveres kun efter recept, og behandlingen bør indledes af en læge med erfaring i diagnosticering og behandling af den pågældende sygdom.
English: RoActemra can also be used in adults and children from 2 years of age for the treatment of severe or life-threatening cytokine release syndrome (CRS, a condition that can cause nausea, vomiting, pain and low blood pressure).
Danish: RoActemra kan også anvendes til voksne og til børn fra toårsalderen til behandling af svær eller livstruende cytokinfrigivelsessyndrom (CRS, en tilstand, der kan forårsage kvalme, opkastning, smerter og lavt blodtryk).
English: RoActemra contains the active substance tocilizumab.
Danish: RoActemra indeholder det aktive stof tocilizumab.
English: One of the studies, which involved 1,196 patients, also showed that the combination of RoActemra and methotrexate slowed down the damage to the joints and improved physical function after up to 2 years, when compared with the combination of placebo and methotrexate.
Danish: Ét af studierne, som omfattede 1 196 patienter, viste også, at kombinationen af RoActemra og methotrexat bremsede ledskaderne og forbedrede den fysiske funktion efter op til to år sammenlignet med kombinationen af placebo og methotrexat.
English: The active substance in RoActemra, tocilizumab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a specific target (called an antigen) in the body.
Danish: Det aktive stof i RoActemra, tocilizumab, er et monoklonalt antistof, dvs. en type protein, der er opbygget, så det genkender og binder sig til et specifikt mål (et antigen) i kroppen.
English: What are the risks associated with RoActemra?
Danish: Hvilke risici er der forbundet med RoActemra?
English: RoActemra is used in combination with methotrexate for these conditions but it can be used on its own in patients for whom methotrexate is inappropriate.
Danish: RoActemra anvendes sammen med methotrexat ved disse sygdomme, men kan også anvendes alene hos patienter, som ikke har gavn af methotrexat.
English: RoActemra, on its own or in combination with methotrexate, was compared with placebo (a dummy treatment) plus methotrexate.
Danish: RoActemra givet alene eller sammen med methotrexat blev sammenlignet med placebo (en uvirksom behandling) plus methotrexat.
English: Other information about RoActemra:
Danish: Andre oplysninger om RoActemra
English: RoActemra given by infusion was considered to be effective at treating severe CRS based on a review of data from 66 patients who experienced this condition after they were given CAR-T cell medicines to treat a blood cancer.
Danish: RoActemra givet som infusion blev vurderet at være effektivt til behandling af svær cytokinfrigivelsessyndrom baseret på en gennemgang af data fra 66 patienter, som oplevede denne tilstand, efter at de havde fået CAR-T-cellelægemidler til behandling af blodkræft.
English: The main measure of effectiveness was based on the number of patients whose CRS resolved within 14 days of the first dose of RoActemra, and who needed no more than two doses of the medicine, and no additional treatment other than corticosteroid medicines.
Danish: Virkningen blev hovedsagelig målt på antallet af patienter, hvis cytokinfrigivelsessyndrom fortog sig inden for 14 dage efter den første dosis RoActemra, og som kun behøvede mere end to doser af lægemidlet og ingen anden tillægsbehandling end kortikosteroider.
English: The most common side effects (occurring in up to 1 patient in 10) with RoActemra are upper respiratory tract infections (nose and throat infection), nasopharyngitis (inflammation of the nose and throat), headache, hypertension (high blood pressure) and abnormal liver function tests.
Danish: De hyppigste bivirkninger ved RoActemra (som forekommer hos op til 1 ud af 10 patienter) er infektioner i de øvre luftveje (næse og hals), nasofaryngitis (betændelse i næse og hals), hovedpine, hypertension (forhøjet blodtryk) og unormale resultater af leverfunktionsprøver.
English: In the first study, RoActemra was more effective than placebo in treating rheumatoid arthritis: after 6 months of treatment with RoActemra, 61% of patients responded to treatment compared with 32% on placebo.
Danish: I det første studie var RoActemra mere effektivt end placebo til behandling af leddegigt: Efter 6 måneders behandling med RoActemra responderede 61 % af patienterne på behandlingen sammenlignet med 32 % ved behandling med placebo.
English: Giant cell arteritis
Danish: Kæmpecellearteritis
English: Another study involving 51 children from 1 year of age showed that RoActemra given by injection under the skin had a similar distribution in the body and effect on the disease to that previously seen with RoActemra given by infusion.
Danish: Et andet studie med 51 børn fra etårsalderen viste, at RoActemra givet som injektion under huden gav den samme fordeling i kroppen og samme virkning på sygdommen, som tidligere var set ved RoActemra givet som infusion.
English: One year after starting treatment, 56% of patients treated with RoActemra once a week did not have symptoms compared with 14% patients receiving placebo.
Danish: Et år efter behandlingsstart var 56 % af de patienter, der fik RoActemra én gang om ugen, symptomfrie, sammenlignet med 14 % af de patienter, der fik placebo.
English: The fifth study involving 673 patients showed that patients receiving RoActemra on its own were more likely to respond than those taking methotrexate on its own.
Danish: Af det femte studie, der omfattede 673 patienter, fremgik det, at der hos patienter, som fik RoActemra alene, var større sandsynlighed for behandlingsrespons end hos dem, der fik methotrexat alene.
English: How RoActemra is given, its dose and how often it is given depends on the condition it is used to treat.
Danish: Indgivelsesmåde, dosis og indgivelseshyppighed afhænger af den sygdom, der skal behandles.
English: Out of 51 patients who had CRS after being given the CAR-T cell medicine tisagenlecleucel, 39 responded to treatment with RoActemra (76.5%), while 8 out 15 patients (53.3%) who had CRS after being given axicabtagene ciloleucel responded.
Danish: Ud af de 51 patienter, som havde cytokinfrigivelsessyndrom efter at have fået CAR-T-cellelægemidlet tisagenlecleucel, responderede 39 på behandlingen med RoActemra (76,5 %), mens 8 ud af 15 patienter (53,3 %), der havde cytokinfrigivelsessyndrom efter at have fået axicabtagenciloleucel, responderede.
English: For the full list of side effects of RoActemra, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved RoActemra fremgår af indlægssedlen.
English: In three of these studies, RoActemra was compared with placebo, as an add-on to failing treatment with conventional rheumatoid arthritis medicines in a total of over 3,000 patients.
Danish: I tre af disse studier blev RoActemra sammenlignet med placebo som tillægsbehandling til en resultatløs behandling med konventionelle lægemidler mod leddegigt hos i alt over 3 000 patienter.
English: CRS is a side effect of certain cancer treatments and RoActemra is used for CRS caused by chimeric antigen receptors (CAR) T-cell medicines.
Danish: Cytokinfrigivelsessyndrom er en bivirkning ved visse kræftbehandlinger, og RoActemra anvendes til cytokinfrigivelsessyndrom, som skyldes kimærisk antigenreceptor-protein (CAR) T-cellelægemidler.
English: This messenger is involved with inflammation and is found at high levels in patients with rheumatoid arthritis, systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis and CRS.
Danish: Dette signalmolekyle er en medvirkende årsag til betændelse og findes i store mængder hos patienter med leddegigt (rheumatoid artritis), systemisk børneleddegigt (systemisk juvenil idiopatisk artritis), børneleddegigt i mange led (juvenil idiopatisk polyartritis), kæmpecellearteritis og cytokinfrigivelsessyndrom.
English: Juvenile idiopathic arthritis
Danish: Børneleddegigt (juvenil idiopatisk artritis)
English: RoActemra is also used to treat adults with giant cell arteritis, a disease in which arteries, usually of the head, are swollen.
Danish: RoActemra anvendes også til behandling af voksne med såkaldt kæmpecellearteritis, dvs. blodårebetændelse, hvor arterierne (blodårerne), typisk i hovedet, er hævede.