FrancophonIA/ELRC3.0 huggingface dataset:
English: if you have had a clot in an artery of your brain (ischaemic stroke) which occurred within the if you have kidney or liver disease.
Danish: • hvis du har haft en blodprop i en åre (arterie) i hjernen (iskæmisk apopleksi), inden for de
English: - a planned surgery (including dental) in the next seven days.
Danish: en blødningslidelse, der giver dig tendens til indre blødning (blødning inde i et af et nyligt kirurgisk indgreb (gælder også tandoperationer) et planlagt kirurgisk indgreb (gælder også tandoperationer) inden for de næste 7 dage
English: Clopidogrel Acino 75 mg
Danish: INFORMATION I BRAILLESKRIFT Clopidogrel Acino 75 mg
English: predisposition to falling or head trauma, or specific risk of bleeding; for 26% of the patients, the physician's decision was based on the patient's unwillingness to take VKA.
Danish: For 26 % af patienterne var lægens beslutning baseret på patientens modvilje mod at tage VKA.
English: What you need to know before you take Clopidogrel Acino
Danish: Oversigt over indlægssedlen: Det skal du vide, før du begynder at tage Clopidogrel Acino
English: For any information about this medicine, please contact the Marketing Authorisation Holder.
Danish: Hvis du ønsker yderligere oplysninger om Clopidogrel Acino, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28 July 2009
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel Acino 75 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Clopidogrel Acino 75 mg filmovertrukne tabletter
English: You have a condition of hardening of arteries (also known as atherosclerosis), and You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease (disturbed blood flow in arms or legs caused by vascular
Danish: Du har fået recept på Clopidogrel Acino til forebyggelse af blodpropper og nedsættelse af risikoen for disse alvorlige hændelser, fordi: - du lider af åreforkalkning (også kaldet aterosklerose) - og - du tidligere har haft et hjerteanfald, apopleksi eller en tilstand kaldet perifer arteriel sygdom (kredsløbsforstyrrelser i arme eller ben, forårsaget af vaskulær okklusion), eller - du har haft en alvorlig form for smerter i brystet, som kaldes hjertekrampe (ustabil angina pectoris) eller hjerteanfald (myokardieinfarkt).
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel Acino 75 mg film-coated tablets Clopidogrel
Danish: LÆGEMIDLETS NAVN Clopidogrel Acino 75 mg filmovertrukne tabletter Clopidogrel
English: 4.1 Therapeutic indications Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: Patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial
Danish: • Patienter med myokardieinfarkt (fra få dage, men ikke over 35 dage), iskæmisk slagtilfælde (fra 7 dage, men ikke over 6 måneder) eller påviste perifere
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,
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 (inklusive, 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: Read the package leaflet before use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ (E) Læs indlægssedlen inden brug.
English: You have been prescribed Clopidogrel Acino to help prevent blood clots and reduce the risk of these severe events because:
Danish: Clopidogrel er indiceret hos voksne til forebyggelse af aterotrombotiske hændelser hos:
English: What Clopidogrel Acino contains The active substance is clopidogrel.
Danish: Hjælpestoffer Clopidogrel Acino indeholder hydrogeneret ricinusolie.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Danish: Brug af anden medicin sammen med Clopidogrel Acino Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nyligt.
English: - a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues,
Danish: en medicinsk lidelse, der medfører risiko for indre blødninger (såsom et mavesår)
English: These may be due to rare decrease of some blood
Danish: Dette kan ske på grund af et
English: Other medicines and Clopidogrel Acino
Danish: Pakningsstørrelser og yderligere oplysninger Clopidogrel Acino indeholder:
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE
English: Posology
Danish: Øjne
English: Marketing Authorisation Holder and Manufacturer
Danish: Indehaver af markedsføringstilladelsen og fremstiller Acino AG
English: This summary was last updated in June 2013.
Danish: Dette sammendrag blev sidst ajourført i juni 2013.
English: If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).
Danish: Hvis du ønsker yderligere oplysninger på grundlag af CVMP's anbefalinger, kan du læse den faglige drøftelse (der ligeledes er en del af EPAR).
English: For cats 9 weeks and older, two doses are given at an interval of 3 to 4 weeks.
Danish: Til katte, der er 9 uger eller derover, gives to doser med 3 til 4 ugers mellemrum.
English: The Package Leaflet should be taken to the doctor.
Danish: Indlægssedlen skal vises til lægen.
English: Information on the prescription status of this product may be found on the outer package.
Danish: Oplysninger om udleveringsbestemmelser for produktet findes på den ydre emballage.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Fevaxyn Pentofel on 5 February 1997.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Fevaxyn Pentofel den 5. februar 1997.
English: If someone is accidentally injected with this product, they must seek immediate medical advice even if only a very small amount is injected.
Danish: Hvis man ved et uheld sprøjter produktet i sig, skal man straks søge lægehjælp, selv om den indsprøjtede mængde er meget lille.
English: The benefit-risk balance may be found in the scientific discussion of this EPAR.
Danish: En afvejning af fordele og risici fremgår af videnskabelige diskussion af denne EPAR.
English: In the trial to observe side effects, there were no side effects in 94.2 % of cats for the first vaccination and no side effects observed for 99 % of cats for the second vaccination.
Danish: I undersøgelsen af forekomsten af bivirkninger var der ingen bivirkninger hos 94,2 % af kattene efter første vaccination og ingen bivirkninger hos 99 % af kattene efter anden vaccination.
English: When injected, this small exposure helps the cat's immune system to recognise and attack the viruses and bacterium.
Danish: Når katten får injektionen, vil denne lille påvirkning bevirke, at kattens immunsystem genkender og angriber de pågældende virus og bakterier.
English: When exposed to any of these viruses and bacterium later in life, the cat will either not become infected or will have a much less serious infection.
Danish: Når katten senere udsættes for sådanne virus og bakterier, vil katten enten ikke blive inficeret, eller også bliver infektionen ikke nær så alvorlig.
English: The contents of the prefilled syringe are shaken and given by subcutaneous (under the skin) injection.
Danish: Indholdet af den forfyldte sprøjte omrystes og gives ved subkutan injektion (indsprøjtning under huden).
English: Fevaxyn Pentofel is then given once every year.
Danish: Derefter gives Fevaxyn Pentofel en gang om året.
English: Fevaxyn Pentofel contains small amounts of four inactivated viruses and one inactivated bacterium.
Danish: Fevaxyn Pentofel indeholder små mængder af fire inaktiverede virus og én inaktiveret bakterie.
English: Fevaxyn Pentofel contains mineral oil.
Danish: Fevaxyn Pentofel indeholder mineralsk olie.
English: Accidental injection may cause severe pain and swelling, particularly if injected into a joint or finger - rarely causing the loss of a finger.
Danish: Selvinjektion ved uheld kan forårsage stærk smerte og hævelse, navnlig ved injektion i led eller fingre - i sjældne tilfælde med tab af fingeren til følge.
English: In addition, studies in cats of various breeds were carried out to observe any side effects of Fevaxyn Pentofel after the first and second vaccinations.
Danish: Derudover er der indsamlet oplysninger fra undersøgelser hos forskellige katteracer med henblik på forekomsten af bivirkninger efter første og anden vaccination med Fevaxyn Pentofel.
English: Other information about Fevaxyn Pentofel:
Danish: Andre oplysninger om Fevaxyn Pentofel:
English: An additional dose is recommended for kittens living in high-risk areas for feline leukaemia virus whose first dose was administered before 12 weeks of age.
Danish: En ekstra vaccination anbefales til killinger i områder med høj risiko for felin leukæmivirus, hvis killingen har fået den første vaccination inden 12-ugers alderen.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Fevaxyn Pentofel are greater than any risks to immunise healthy cats of 9 weeks or older against feline viruses.
Danish: Udvalget for Veterinærlægemidler (CVMP) fandt, at fordelene ved Fevaxyn Pentofel opvejer eventuelle risici til immunisering af raske katte på 9 uger eller derover mod feline virus.
English: Occasionally there is swelling, pain, pruritus (itching) or hair loss at the injection site.
Danish: Undertiden kommer der hævelse, smerte, kløe eller hårtab på injektionsstedet.
English: Fevaxyn Pentofel is a vaccine for cats which is a solution for injection in a prefilled syringe.
Danish: Fevaxyn Pentofel er en vaccine til katte og leveres som injektionsvæske (opløsning) i en fyldt sprøjte.
English: In very rare cases there is an anaphylactic reaction (severe allergy) with oedema (fluid under the skin), pruritus, respiratory and cardiac distress, severe gastrointestinal signs or shock during the first hours after vaccination.
Danish: I meget sjældne tilfælde udvikles der i løbet af de første timer efter vaccinationen overfølsomhedsreaktioner med væskeansamling i huden, kløe, åndedræts- og hjertesvigt, alvorlige symptomer fra mavetarmsystemet eller chok.
English: Why has Fevaxyn Pentofel been approved?
Danish: Hvorfor blev Fevaxyn Pentofel godkendt?
English: Some vaccinated cats may develop reactions to the vaccine, which include temporary fever, vomiting, anorexia (not eating), and/or depression, which usually disappear within 24 hours.
Danish: Hos nogle katte kan vaccinationen bevirke reaktioner bestående i forbigående feber, opkastning, nedsat ædelyst og/eller depression.
English: How has the effectiveness of Fevaxyn Pentofel been studied?
Danish: Hvordan blev virkningen af Fevaxyn Pentofel undersøgt?
English: They recommended that Fevaxyn Pentofel should be given a marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Fevaxyn Pentofel.
English: What are the side effects of Fevaxyn Pentofel?
Danish: Hvilke bivirkninger har Fevaxyn Pentofel?
English: What is Fevaxyn Pentofel?
Danish: Hvad er Fevaxyn Pentofel?
English: Fevaxyn Pentofel is used to immunise healthy cats of 9 weeks or older against feline panleukopenia and feline leukaemia and against respiratory diseases caused by feline rhinotracheitis virus, feline calicivirus and feline Chlamydophila felis.
Danish: Fevaxyn Pentofel anvendes til immunisering af raske katte fra 9-ugers alderen mod felin panleukopenivirus og felin leukæmivirus samt mod luftvejssygdomme forårsaget af felin rhinotracheitisvirus, felin calicivirus og felin Chlamydophila felis.
English: Fevaxyn Pentofel contains the following inactivated viruses: feline panleukopenia virus, feline rhinotracheitis virus, feline calicivirus, feline leukaemia virus, and the inactivated bacterium feline Chlamydophila felis.
Danish: Fevaxyn Pentofel indeholder følgende inaktiverede (dræbte) vira: felin (katte-) panleukopenivirus, felin rhinotracheitisvirus, felin calicivirus, felin leukæmivirus og den inaktiverede bakterie Chlamydophila felis.
English: What is Fevaxyn Pentofel used for?
Danish: Hvad anvendes Fevaxyn Pentofel til?
English: Fevaxyn Pentofel has been shown to be effective against Feline Leukaemia, against respiratory diseases caused by feline rhinotracheitis virus, feline calicivirus and feline Chlamydophila felis, as well as against disease caused by feline panleukopenia virus.
Danish: Fevaxyn Pentofel er påvist at være effektiv mod felin leukæmivirus, mod luftvejssygdomme forårsaget af felin rhinotracheitisvirus, felin calicivirus og felin Chlamydophila felis samt mod sygdom forårsaget af felin panleukopenivirus.
English: How does Fevaxyn Pentofel work?
Danish: Hvordan virker Fevaxyn Pentofel?
English: Fevaxyn Pentofel has been studied against Feline Leukaemia, against respiratory diseases caused by feline rhinotracheitis virus, feline calicivirus and feline Chlamydophila felis, as well as against disease caused by feline panleukopenia virus.
Danish: Fevaxyn Pentofel blev undersøgt over for felin leukæmivirus, over for luftvejssygdomme forårsaget af felin rhinotracheitisvirus, felin calicivirus og felin Chlamydophila felis samt over for sygdom forårsaget af felin panleukopenivirus.
English: What benefit has Fevaxyn Pentofel shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Fevaxyn Pentofel?
English: Inactivated Bordetella pertussis strain** ≥ 4 IU Hepatitis B virus surface Antigen recombinant** (S protein)*** 10 micrograms * adsorbed on aluminium oxide hydrated Total: 0.26 milligrams Al ** adsorbed on aluminium phosphate Total: 0.37 milligrams Al3+
Danish: Inaktiv Bordetella pertussis stamme** ≥ 4 IU Hepatitis B virus overflade Antigen rekombinant** (S protein)*** 10 mikrogram * adsorberet på aluminium oxid hydrat Total: 0.26 milligram Al3+ ** adsorberet på aluminium fosfat Total: 0.37 milligram Al3+ *** fremstillet af genetisk modificerede gær celler (Saccharomyces cerevisiae)
English: Invented name Strength Pharmaceutical Form Route of administration
Danish: Styrke Lægemiddelform Indgivelsesvej
English: Diphtheria toxoid* ≥ 30 IU Tetanus toxoid*
Danish: Tetanus toxoid*
English: 1 dose (0.5 ml) contains:
Danish: 1 dosis (0.5 ml) indeholder: Diphtheria toxoid*
English: Frequently Asked Questions
Danish: Ofte stillede spørgsmål
English: This can happen.
Danish: Dette kan forekomme.
English: Date of first authorisation: 19 September 2013 Date of latest renewal: 22 May 2018
Danish: Dato for første markedsføringstilladelse: 19. september 2013 Dato for seneste fornyelse: 22. maj 2018
English: Breathe in quickly and as deeply as you can.
Danish: Tag en hurtig og så dyb indånding som muligt.
English: Supportive and symptomatic treatment is indicated.
Danish: Understøttende og symptomatisk behandling er indiceret.
English: Hold breath Hold your breath for up to 5 seconds.
Danish: Hold vejret Hold vejret i op til 5 sekunder.
English: This makes breathing difficult.
Danish: Dette gør det svært at trække vejret.
English: Information on the potential for interactions is based on the potential for each of its two active substances.
Danish: Oplysning om potentialet for interaktioner er baseret på potentialet for hver af de to aktive stoffer.
English: This is because it has not been studied in this age group.
Danish: Dette skyldes, at medicinen ikke har været undersøgt i denne aldersgruppe.
English: Do not give this medicine to children or adolescents below the age of 18 years.
Danish: Denne medicin må ikke gives til børn eller unge under 18 år.
English: Why didn't the inhaler make a noise when I inhaled?
Danish: Hvorfor lavede inhalatoren ikke en lyd, da jeg inhalerede?
English: Daily activities
Danish: Daglige aktiviteter
English: You have not received enough of your medicine.
Danish: Du har ikke fået en tilstrækkelig mængde af din medicin.
English: Some side effects may be serious:
Danish: Nogle bivirkninger kan være alvorlige:
English: It did not suggest any difference between ethnic subgroups in this population.
Danish: Den antydede ingen forskelle mellem etniske undergrupper i denne population.
English: In serious cases, patients should be hospitalised.
Danish: I alvorlige tilfælde skal patienten behandles på hospitalet.
English: Patients should be instructed not to take more than one dose in a day.
Danish: Patienterne skal informeres om, at de ikke må tage mere end én dosis om dagen.
English: Place the mouthpiece in your mouth and close your lips firmly around it.
Danish: Tag mundstykket i munden, og luk læberne tæt omkring det.
English: As long as the capsule is empty you have received enough of your medicine.
Danish: Så længe at kapslen er tom, har du fået en tilstrækkelig mængde af din medicin.
English: No difference between ethnic subgroups was identified.
Danish: Der er ikke identificeret forskelle mellem etniske subgrupper.
English: During inhalation you will hear a whirring noise.
Danish: Under inhalationen vil du høre en snurrende lyd.
English: There are no data on the use of this medicine in pregnant women and it is not known whether the active substances of this medicine pass into human milk.
Danish: Der er ingen data om brug af dette lægemiddel til gravide kvinder, og det vides ikke, hvorvidt det aktive stof i denne medicin udskilles i human mælk.
English: Metabolic and transporter based interactions
Danish: Metaboliske og transporterbaserede interaktioner
English: Patients who do not experience improvement in breathing should be asked if they are swallowing the medicinal product rather than inhaling it.
Danish: Patienter, der ikke oplever en forbedring i vejrtrækningen, skal spørges om de sluger lægemidlet i stedet for at inhalere det.
English: These patients should be monitored closely for potential adverse reactions.
Danish: Disse patienter skal monitoreres nøje for potentielle bivirkninger.
English: However, this medicine may cause dizziness (see section 4).
Danish: Dette lægemiddel kan dog forårsage svimmelhed (se punkt 4).
English: All these findings occurred at exposures sufficiently in excess of those anticipated in humans.
Danish: Alle disse resultater blev observeret ved eksponeringer, der i væsentlig grad overstiger de, der forventes hos mennesker.
English: • voice alteration (hoarseness).
Danish: • stemmeforandringer (hæshed).
English: Patients should be instructed on how to administer the medicinal product correctly.
Danish: Patienter skal informeres om korrekt administration af lægemidlet.
English: These belong to a group of medicines called bronchodilators.
Danish: De tilhører en gruppe af lægemidler, der kaldes bronkodilatatorer.
English: If you use this medicine once a day, it will help to reduce the effects of COPD on your everyday life.
Danish: Hvis du tager dette lægemiddel én gang daglig, vil det hjælpe med at mindske påvirkningen af KOL i din dagligdag.
English: The chances of the capsule breaking into small pieces will be increased if the capsule is pierced more than once.
Danish: Risikoen for at kapslen går i små stykker forøges, hvis kapslen perforeres mere end én gang.
English: If a dose is missed, it should be taken as soon as possible on the same day.
Danish: Hvis en dosis glemmes, skal den tages så hurtigt som muligt samme dag.
English: Each blister contains either 6 or 10 hard capsules.
Danish: Hver blister indeholder enten 6 eller 10 kapsler.
English: This medicine contains lactose (23.5 mg per capsule).
Danish: Dette lægemiddel indeholder lactose (23,5 mg pr. kapsel).
English: If you get any of these serious side effects, seek medical help immediately.
Danish: Hvis du oplever en af disse bivirkninger, skal du øjeblikkeligt søge lægehjælp.
English: Elderly (age 75 years and over) You can use this medicine if you are aged 75 years and over at the same dose as for other adults.
Danish: Ældre (75 år og derover) Du kan tage denne medicin ved samme dosis som for andre voksne, hvis du er 75 år eller ældre.
English: Do not inhale more than one dose on the same day.
Danish: Inhalér ikke mere end én dosis på samme dag.
English: I coughed after inhaling - does this matter?
Danish: Jeg hostede efter jeg inhalerede - betyder det noget?
English: In case such effects occur with this medicinal product, treatment may need to be discontinued.
Danish: Hvis sådanne virkninger forekommer med dette lægemiddel, kan det muligvis være nødvendigt at seponere behandlingen.
English: The maximal effect on blood glucose was 0.67 mmol/l.
Danish: Den maksimale virkning på blodglucose var 0,67 mmol/l.
English: Do not use more than your doctor tells you to use.
Danish: Tag ikke mere end den dosis lægen anbefaler dig at bruge.
English: • swollen hands, ankles and feet.
Danish: • hævede hænder, ankler og fødder.
English: For instructions on use of the medicinal product before administration, see section 6.6.
Danish: For instruktioner om brug af lægemidlet før administration, se pkt.
English: - medicines that lower the amount of potassium in your blood.
Danish: medicin, som nedsætter mængden af kalium i blodet.
English: Biliary clearance contributes to the non-renal clearance, but the majority of non-renal clearance is thought to be due to metabolism.
Danish: Biliær clearance bidrager til ikke-renal clearance, men størstedelen af ikke-renal clerance menes at skyldes metabolisme.
English: You may taste the medicine as you inhale.
Danish: Du kan muligvis smage medicinen mens du inhalerer.
English: Lean body weight (which is a function of weight and height) was identified as a covariate.
Danish: Fedt-fri legemsvægt (som er en funktion af vægt og højde) blev identificeret som en kovariant.
English: Description of selected adverse reactions Cough was common, but usually of mild intensity.
Danish: Beskrivelse af udvalgte bivirkninger Hoste var almindelig men sædvanligvis af mild sværhedsgrad.
English: A hydroxylated derivative was the most prominent metabolite in serum.
Danish: Et hydroxyleret derivat var den mest fremtrædende metabolit i serum.
English: Needles and springs are made from stainless steel.
Danish: Nåle og fjedre er fremstillet af rustfrit stål.
English: Medical attention may be needed.
Danish: Behandling kan være nødvendig.