FrancophonIA/ELRC3.0 huggingface dataset:
English: Jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions (for example, overall sensation of heat with sudden general discomfort until fainting); swelling in the mouth; blisters of the skin; skin allergy; sore mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in taste of food.
Danish: generelle allergiske reaktioner (f.eks. varmefølelse over hele kroppen med pludselig almen utilpashed og eventuel besvimelse); hævelse i munden; blærer på huden; hudallergi; ømhed i munden (stomatitis); blodtryksfald; forvirring; hallucinationer; ledsmerter; muskelsmerter; smagsforstyrrelser.
English: If you forget to take Clopidogrel Teva Pharma
Danish: Hvis du har glemt at tage Clopidogrel Teva Pharma
English: You should specifically tell your doctor if you take - medicines that may increase your risk of bleeding such as: o oral anticoagulants, medicines used to reduce blood clotting, o a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints, o heparin or any other injectable medicine used to reduce blood clotting, o ticlopidine, other antiplatelet agent, o a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression, - omeprazole or esomeprazole, medicines to treat upset stomach,
Danish: Det er særlig vigtigt, at du fortæller det til din læge, hvis du tager: - medicin, der kan øge risikoen for blødning, såsom: o blodfortyndende medicin, der tages gennem munden for at nedsætte dannelse af blodpropper o en type smertestillende medicin (nonsteroide antiinflammatoriske lægemidler, NSAID'er), som normalt gives til behandling af smertefulde og/eller betændelseslignende tilstande i muskler eller led o heparin eller anden medicin til indsprøjtning for at nedsætte dannelse af blodpropper o ticlopidin, der er anden medicin mod blodpropper o selektive serotoningenoptagelseshæmmere (herunder, men ikke begrænset til fluoxetin og fluvoxamin), der normalt anvendes mod depression - omeprazol eller esomeprazol til behandling af for meget mavesyre - fluconazol eller voriconazol, der anvendes til behandling af svampeinfektioner - efavirenz, der anvendes til behandling af hiv- (humant immundefektvirus) infektion - carbamazepin, der anvendes mod bestemte former for epilepsi - moclobemid, medicin mod depression - repaglinid, medicin til behandling af diabetes - paclitaxel, medicin til behandling af kræft.
English: While you are taking Clopidogrel Teva Pharma:
Danish: Mens du er i behandling med Clopidogrel Teva Pharma:
English: Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction): clopidogrel treatment should be initiated with a single 300-mg loading dose and then continued at 75 mg once a day (with acetylsalicylic acid (ASA) 75 mg-325 mg daily).
Danish: Hos patienter med akut koronarsyndrom: - akut koronarsyndrom uden elevation af ST-segmentet (ustabil angina pectoris eller myokardieinfarkt uden forekomst af Q-takker): Behandling med clopidogrel bør indledes med en enkelt initial mætningsdosis på 300 mg, hvorefter behandlingen består af 75 mg en gang daglig (sammen med acetylsalicylsyre (ASA) 75 mg - 325 mg/dag).
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder
Danish: Hvis du ønsker yderligere oplysninger om Clopidogrel Teva Pharma, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Other medicines and Clopidogrel Teva Pharma Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.
Danish: Brug af anden medicin sammen med Clopidogrel Teva Pharma Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nyligt.
English: EU/1/09/561/001 Cartons of 7 film-coated tablets in OPA/Al/PVC - Al blisters
Danish: EU/1/09/561/001 Æsker med 7 filmovertrukne tabletter i OPA/Al/PVC - Al-blistere
English: Clopidogrel Teva Pharma 75 mg film-coated tablets Clopidogrel
Danish: Clopidogrel Teva Pharma 75 mg filmovertrukne tabletter Clopidogrel
English: • if you have a risk of bleeding such as - a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer) - a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body).
Danish: • hvis du har risiko for blødning f.eks på grund af: - en medicinsk lidelse, der medfører risiko for indre blødninger (så som et mavesår) - en blødningsforstyrrelse, der giver dig tendens til indre blødning (blødning i et af kroppens væv, organer eller led) - en nylig alvorlig skade - en nylig operation (herunder tandoperation) - en planlagt operation (herunder tandoperation) inden for de næste 7 dage.
English: What you need to know before you take Clopidogrel Teva Pharma
Danish: Det skal du vide, før du begynder at tage Clopidogrel Teva Pharma
English: EU/1/09/561/011 Cartons of 50x1 film-coated tablets in OPA/Al/PVC - Al perforated unit-dose blisters
Danish: EU/1/09/561/011 Æsker med 50x1 filmovertrukne tabletter i OPA/Al/PVC - Al-perforerede
English: Do not stop the treatment unless your doctor tells you so.
Danish: Hvis du holder op med at tage Clopidogrel Teva Pharma Du må ikke stoppe behandlingen, medmindre din læge fortæller dig, at du skal gøre det.
English: Calendar days Mon
Danish: Kalenderdage Man
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, non-CNS 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: Clopidogrel has no or negligible influence on the ability to drive and use machines.
Danish: 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner Clopidogrel påvirker ikke, eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
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: INFORMATION IN BRAILLE Clopidogrel Teva Pharma 75 mg
Danish: Clopidogrel Teva Pharma 75 mg
English: Do not throw away any medicines via wastewater or household waste.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet.
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 endepunkt [kardiovaskulært dødsfald, myokardieinfarkt, apopleksi 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=0,00005) for clopidogrelgruppen.
English: Fertility Clopidogrel was not shown to alter fertility in animal studies.
Danish: I dyreforsøg blev det ikke vist, at Clopidogrel ændrer fertiliteten.
English: However, patients entered into clinical trials with clopidogrel received a variety of concomitant medicinal products including diuretics, beta blockers, ACEI, calcium antagonists, cholesterol lowering agents, coronary vasodilators, antidiabetic agents
Danish: Imidlertid fik de patienter, som indgik i kliniske studier med clopidogrel, en lang række lægemidler samtidigt, såsom diuretika, beta-blokkere, ACE-hæmmere, calciumantagonister, kolesterolsænkende midler, dilatatorer med effekt på koronarkarrene, antidiabetika (inklusive insulin), antiepileptika samt GPIIb/IIIa-hæmmere, uden at der blev påvist klinisk signifikante uønskede interaktioner.
English: Tel: +44(0) 1977 628500
Danish: United Kingdom Teva UK Limited Tel: +44(0) 1977 628500
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel Teva Pharma 75 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Clopidogrel Teva Pharma 75 mg filmovertrukne tabletter
English: There was no statistically significant difference in the rates of fatal bleeding (1.1% in the clopidogrel + ASA group and 0.7% in the placebo +ASA group) and haemorrhagic stroke (0.8% and 0.6%, respectively) between groups.
Danish: ASA-gruppen og 0,7 % i placebo + ASA-gruppen) og hæmoragisk apopleksi (henholdsvis 0,8 % og 0,6 %) mellem grupperne.
English: Breast-feeding
Danish: Clopidogrel
English: What Clopidogrel Teva Pharma looks like and contents of the pack The film-coated tablets are pink, round and slightly convex.
Danish: De filmovertrukne tabletter er lyserøde, runde og let hvælvede.
English: How to take Clopidogrel Teva Pharma
Danish: Sådan skal du tage Clopidogrel Teva Pharma
English: What Clopidogrel Teva Pharma is and what it is used for What you need to know before you take Clopidogrel Teva Pharma How to take Clopidogrel Teva Pharma Possible side effects
Danish: Det skal du vide, før du begynder at tage Clopidogrel Teva Pharma Sådan skal du tage Clopidogrel Teva Pharma Bivirkninger
English: • Tablet core: microcrystalline cellulose, colloidal anhydrous silica, crospovidone (type A), macrogol 6000 and hydrogenated castor oil
Danish: - De øvrige indholdsstoffer er: - Tabletkernen: mikrokrystallinsk cellulose, vandfri kolloid silica, crospovidon (type A),
English: Bleeding at puncture site
Danish: INFORMATION I BRAILLESKRIFT
English: Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, sensation of tingling and numbness.
Danish: Ikke almindelige bivirkninger (kan påvirke op til 1 ud af 100 patienter): Hovedpine, mavesår, opkastninger, kvalme, forstoppelse, luft i maven eller tarmene, udslæt, kløe, svimmelhed, prikkende fornemmelse og følelsesløshed.
English: LIST OF EXCIPIENTS It also contains hydrogenated castor oil.
Danish: Indeholder hydrogeneret ricinusolie.
English: This medicinal product contains hydrogenated castor oil which may cause stomach upset and diarrhoea.
Danish: Det kan give mavebesvær eller diarré.
English: Thu
Danish: Tors
English: Polska
Danish: България
English: Pharmachemie B.V. Swensweg 5, 2031 GA Haarlem The Netherlands
Danish: 2031 GA Haarlem Holland
English: Method of administration For oral use
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E)
English: Powder: 220 mg Solvent:5 ml
Danish: Pulver: 220 mg Solvens:5 ml
English: Powder and solvent for solution for injection
Danish: Pulver og solvens til opløsning, injektion
English: 4 vials powder+ 4 vials solvent + 8 disposable 3 ml syringes + 8 disposable 27-gauge, ½ inch needles
Danish: 4 hætteglas med pulver+ 4 hætteglas med solvens + 8 engangssprøjter på 3 ml + 8 27-gauge, ½ inch engangskanyler
English: Subcutaneous use Powder: vial (glass) Solvent: LDPE vial
Danish: Pulver: hætteglas (glas) Solvens: LDPE hætteglas
English: - First data-lock point is 30 days later.
Danish: - Første data-lock point er 30 dage senere.
English: CZ-281 63 Kostelec nad Cernymi lesy Czech Republic
Danish: CZ-281 63 Kostelec nad Cernymi lesy Tjekkiet
English: Day 42 a
Danish: Dag 42 a
English: The following principles should be followed when compiling the data:
Danish: Følgende principper bør følges, når data indsamles:
English: Based on the assumption that product name will not be provided in a significant proportion of cases.
Danish: Baseret på antagelsen, at produktnavn ikke vil blive angivet i et signifikant antal hændelser.
English: AESIs will be defined as follows:
Danish: AESI'er vil blive defineret således:
English: - Reporting to be monthly for the first 6 months.
Danish: - Rapportering skal sker månedligt de første 6 måneder.
English: The following age groups will be used: < 2 years, 2-8 years, ≥ 9 years.
Danish: Følgende aldersgrupper skal anvendes: < 2 år, 2-8 år, > 9 år.
English: • if you have a severe infection with a high temperature (over 38°C).
Danish: • hvis du har en alvorlig infektion med høj temperatur (over 38 °C).
English: SPECIAL STORAGE CONDITIONS Store in refrigerator.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i køleskab.
English: The vaccine works by helping the body to produce its own protection (antibodies) against the disease.
Danish: Vaccinen virker ved at hjælpe kroppen med at producere sin egen beskyttelse (antistoffer) mod sygdommen.
English: If this applies to you then your vaccination will usually be postponed until you are feeling better.
Danish: Er dette tilfældet, vil vaccinationen som regel blive udsat, indtil du har det bedre.
English: Depending on and after implementation of vaccine when first pandemic will take place.
Danish: Afhængig af og efter implementering af vaccine, når den første pandemi finder sted.
English: Day 180
Danish: Dag 180
English: The results indicate an overall decline in antibody levels over time.
Danish: Resultaterne indikerer et samlet fald i antistofniveau over tid.
English: • pain in arms and or legs (in the majority of cases reported as pain in the vaccination arm)
Danish: • smerte i arme og/eller ben (i størstedelen af tilfældene rapporteret som smerte i den vaccinerede arm)
English: Product-specific data can be evaluated during signal work-up.
Danish: Produktspecifikke data kan vurderes under signalundersøgelse.
English: Read all of this leaflet carefully, before you are vaccinated because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du vaccineres, da den indeholder vigtige oplysninger.
English: narrow SMQ “Demyelination” (as GBS is also included in this SMQ, there will be an overlap in the number of cases for these two categories).
Danish: snæver SMF ”Demyelinisering” (da GBS også er inkluderet i denne SMF, vil der være en overlapning i antal hændelser for disse to kategorier).
English: Pandemic flu is a type of influenza that occurs every few decades and which spreads rapidly to affect most countries and regions around the world.
Danish: Pandemisk influenza er en type influenza, der kommer med et par årtiers mellemrum og hurtigt spredes for til sidst at berøre de fleste lande og regioner verden over.
English: Format of the simplified PSUR
Danish: Format for den forenklede PSUR
English: - The clock should start from the first Monday after shipment of the first batch of vaccine.
Danish: - Uret bør startes den første mandag efter afsendelse af den første vaccinebatch.
English: - A line listing of fatal cases will be provided in an Annex.
Danish: - En liste over dødelige hændelser skal gives i et Bilag.
English: The frequency cannot be estimated from the available data.
Danish: Hyppigheden kan ikke vurderes ud fra de tilgængelige data.
English: In the event of multiple signals, signal work-up may be prioritised and appropriate timelines for submission of a full signal evaluation report should be provided.
Danish: I tilfælde af flere signaler kan signalundersøgelse prioriteres, og passende tidslinjer for indsendelse af en fuldstændig evalueringsrapport bør angives.
English: - All tables will be based on generic and not product-specific data1.
Danish: - Alle tabeller skal være baseret på generiske og ikke-produktspecifikke data1.
English: All control animals succumbed to the infection.
Danish: Alle kontroldyrene døde af infektionen.
English: - “Cumulatively” means since the use of the vaccine; events not reported during the period of interest should not be presented in the tables.
Danish: - ”Kumuleret” betyder siden anvendelse af vaccinen; hændelser, som ikke er rapporteret i løbet af den aktuelle periode, skal ikke præsenteres i tabellerne.
English: In accordance with Article 114 Directive 2001/83/EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Danish: I henhold til artikel 114 i direktiv 2001/83/EC foretages den officielle batchfrigivelse af et statsligt laboratorium eller et laboratorium udpeget hertil.
English: - All non-medically confirmed events are those that have been entered into the database by the data-lock point.
Danish: - Alle ikke-medicinsk bekræftede hændelser er de hændelser, som er lagt ind i databasen på tidspunktet for data-lock point.
English: 60 years and above
Danish: 60 år og derover
English: Moreover, a 6-monthly cycle may be too long to allow assessment of the safety of a vaccine for which high levels of exposure are expected within a short period of time.
Danish: Desuden kan en 6-måneders cyklus være for lang til vurdering af sikkerheden af en vaccine, som mange kan forventes at blive eksponeret for i løbet af kort tid.
English: This should include data from ongoing studies, or actual use if applicable, of the ‘mock-up' strains.
Danish: Dette bør inkludere data fra igangværende studier eller, hvis muligt, faktisk brug af mock-up-stammerne.
English: The transient false positive reactions could be due to the IgM response by the vaccine.
Danish: De forbigående falsk positive resultater kan skyldes IgM-respons mod vaccinen.
English: Those which have not yet been entered should be reported in the following S-PSUR.
Danish: De hændelser, som endnu ikke er lagt ind, skal rapporteres i den følgende S-PSUR.
English: There were fewer side effects after the second vaccination compared with the first.
Danish: Der var færre bivirkninger efter den anden vaccination end efter den første.
English: • allergic reactions, including severe reactions leading to a dangerous decrease in blood pressure which, if untreated, may lead to shock.
Danish: • allergiske reaktioner, herunder alvorlige reaktioner, der fører til et faretruende fald i blodtryk, der, hvis det ikke behandles, kan medføre shock.
English: A short summary should be provided in which validated signals and areas of concern are highlighted, taking into account information arising from the prospective cohort study described in 4.5.
Danish: Der bør udarbejdes et kort resumé, hvor validerede signaler og problemstillinger markeres, idet der tages højde for information fra det prospektive kohortestudie, som er beskrevet i 4.5.
English: When it has been agreed by the CHMP that the S-PSUR is no longer necessary, a full PSUR covering the period since the data lock point of the last routine PSUR will be submitted within a time frame to be agreed with the Rapporteur.
Danish: Når det er blevet aftalt med CHMP, at S-PSUR'en ikke længere er nødvendig, skal en fuld PSUR, som dækker perioden siden data-lock point for den sidste normale PSUR, indsendes inden for en tidsfrist, som aftales med Rapporteur.
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Danish: Dette er en godkendelse under særlige omstændigheder, og i henhold til artikel 14(8) i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme udføre følgende foranstaltninger:
English: Adults, older people and special risk groups
Danish: Voksne, ældre og særlige risikogrupper
English: Preferred MedDRA Term
Danish: Foretrukken MedDRA-term
English: • if you are having a blood test to look for evidence of infection with certain viruses.
Danish: • hvis du skal have taget en blodprøve for at se efter tegn på infektion med visse vira.
English: The most frequently occurring side effect was injection site pain, which was usually mild.
Danish: Den hyppigste bivirkning var smerter på injektionsstedet, og disse var som regel lette.
English: Only spontaneously reported data should be included in the S-PSUR.
Danish: Kun spontant rapporterede data skal inkluderes i S-PSUR'en.
English: The report should include the following Tables of aggregate data (using the pre-defined templates attached in Annex 2).
Danish: Rapporten bør omfatte følgende tabeller over de samlede data (de foruddefinerede skabeloner, vedhæftet i Bilag 2, skal anvendes).
English: Therefore, 6-monthly or annual PSURs falling within the pandemic period will be replaced by monthly “simplified PSURs” (S-PSUR) accompanied by a summary of vaccine distribution.
Danish: Derfor vil 6-måneders eller årlige PSUR'er, som skal indsendes inden for pandemiperioden, blive erstattet af månedlige, ”forenklede” PSUR'er (S-PSUR), ledsaget af et sammendrag af vaccinedistributionen.
English: These antigens can be considered as ‘novel' antigens and simulate a situation where the target population for vaccination is immunologically naïve.
Danish: Disse antigener kan kaldes ”nye” antigener og simulerer en situation, hvor målpopulationen for vaccination er immunologisk naive.
English: Tested against
Danish: Testet imod
English: The symptoms (signs) of pandemic flu are similar to those of an ‘ordinary' flu but are usually more severe.
Danish: Symptomerne (tegnene) på pandemisk influenza er de samme som ved en ‘almindelig' influenza, men er normalt alvorligere.
English: Frequency of submission
Danish: Hyppighed for indsendelse
English: Children and adolescents aged 3 to 17 years:
Danish: Børn og unge i alderen fra 3 til 17 år:
English: Prior to administration, visually inspect the suspension for any foreign particulate matter and/or abnormal physical appearance.
Danish: Før administration skal suspensionen undersøges visuelt for eventuelle fremmede partikler og/eller unormalt udseende.
English: Pandemic influenza vaccine should be used in accordance with official guidance.
Danish: Pandemisk influenzavaccine bør anvendes i overensstemmelse med officielle retningslinjer.
English: During a pandemic situation, the resources must be concentrated on a timely and effective monitoring of the safety profile of the influenza vaccines used during the pandemic.
Danish: I en pandemisituation skal ressourcerne koncentreres på en rettidig og effektiv monitorering af sikkerhedsprofilen for de influenzavacciner, som anvendes under pandemien.
English: Adults and older people:
Danish: Voksne og ældre personer:
English: • The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Danish: • Det immunologiske respons kan nedsættes, hvis patienten er i immunsupprimerende behandling.
English: - S-PSUR submission to the Rapporteur and CHMP members on Day 45.
Danish: - S-PSUR indsendes til Rapporteur og CHMP-medlemmer på dag 45.
English: PT “Neuritis”
Danish: FT ”Neuritis”
English: • Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Danish: • Antistofdannelse hos patienter med endogen eller iatrogen immunosuppression kan være utilstrækkelig.
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 October 2009
Danish: Dato for første markedsføringstilladelse: 16. oktober 2009
English: • If the pandemic situation allows, immunisation shall be postponed in patients with severe febrile illness or acute infection.
Danish: • Hvis den pandemiske situation tillader det, skal immuniseringen af patienter med alvorlig febril sygdom eller akut infektion udsættes.
English: However, chemical and physical in-use stability has been demonstrated for 3 hours at room temperature.
Danish: Der er påvist kemisk og fysisk holdbarhed i op til 3 timer ved stuetemperatur.
English: However, in a pandemic situation, your doctor may recommend to give the vaccine.
Danish: Under en pandemi kan din læge måske alligevel anbefale at give dig denne vaccine.
English: This vaccine complies with the WHO recommendation and EU decision for the pandemic.
Danish: Denne vaccine opfylder WHO's og EU's anbefalinger for en pandemisk vaccine.