FrancophonIA/ELRC3.0 huggingface dataset:
English: Other concomitant therapy: Since clopidogrel is metabolised to its active metabolite partly by CYP2C19, use of medicinal products that inhibit the activity of this enzyme would be expected to result in reduced drug levels of the active metabolite of clopidogrel.
Danish: Anden samtidig behandling: Anden samtidig behandling: Da clopidogrel til dels metaboliseres til dets aktive metabolit af CYP2C19 kan anvendelse af medicin, der hæmmer aktiviteten af dette enzym, forventes at resultere i nedsat niveau af clopidogrels aktive metabolit.
English: Then, the usual dose is one 75 mg tablet of Clopidogrel HEXAL per day to be taken orally with or without food, and at the same time each day.
Danish: Derefter er den normale dosis 1 tablet Clopidogrel HEXAL à 75 mg daglig, som indtages gennem munden alene eller i forbindelse med et måltid.
English: INFORMATION IN BRAILLE Clopidogrel HEXAL 75 mg
Danish: INFORMATION I BRAILLE-SKRIFT Clopidogrel HEXAL 75 mg
English: Do not stop the treatment unless your doctor tells you so.
Danish: Hvis De holder op med at tage Clopidogrel HEXAL De må ikke ophøre med behandlingen, medmindre Deres læge fortæller Dem, at De skal gøre det.
English: Patients were randomised to clopidogrel (300 mg loading dose followed by 75 mg/day, N = 6,259) or placebo (N = 6,303), both given in combination with ASA (75-325 mg once daily) and other standard therapies.
Danish: Patienterne blev randomiseret til clopidogrel (300 mg initial mætningsdosisefterfulgt af 75 mg/dag, N=6.259) eller placebo (N=6.303), begge i kombination med ASA (75-325 mg en gang daglig) samt anden standardbehandling.
English: HEXAL S.p.A. c/o Sandoz S.p.A. Largo Umberto Boccioni 1 I-21040 Origgio / VA Tel: + 39-02-96 541
Danish: Largo Umberto Boccioni 1 I-21040 Origgio / VA Tel: + 39-02-96 541
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: • very rare (affects less than 1 user in 10,000)
Danish: • Meget sjælden (påvirker færre end 1 ud af 10.000 patienter)
English: Patients received clopidogrel (300 mg loading dose, followed by 75 mg/day, n=1752) or placebo (n=1,739), both in combination with ASA (150 to 325 mg as a loading dose, followed by 75 to 162 mg/day), a fibrinolytic agent and, when appropriate, heparin.
Danish: Patienterne fik clopidogrel (300 mg loading dose efterfulgt af 75 mg daglig, n=1.752) eller placebo (n=1.739) begge i kombination med ASA (150-325 mg som loading dose, herefter 75-162 mg daglig), et fibrinolytisk middel samt heparin, når det var hensigtsmæssigt.
English: signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion (see section 2 ‘Take special care with Clopidogrel HEXAL').
Danish: Dette kan ske på grund af et sjældent fald i visse blodlegemer - tegn på leverproblemer såsom gulning af huden og/eller øjnene (gulsot), uanset om det sker i forbindelse med blødninger, som viser sig under huden som små røde prikker, og/eller forvirring (se afsnit 2'Vær ekstra forsigtig med at tage Clopidogrel HEXAL) - hævelser i munden eller hudproblemer såsom udslæt og kløe, blister på huden.
English: • very common (affects more than 1 user in 10)
Danish: • Meget almindelig (påvirker flere end 1 ud af 10 patienter)
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis De du vil have yderligere oplysninger om {navn}, skal De du henvende dig til den lokale repræsentant:
English: While you are taking Clopidogrel HEXAL:
Danish: Mens De er i behandling med Clopidogrel HEXAL:
English: If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel HEXAL: 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 nogen af følgende situationer gælder for Dem, skal De oplyse det til Deres læge, før De tager Clopidogrel HEXAL: Hvis de har risiko for blødninger f.eks. på grund af: en medicinsk lidelse, der medfører risiko for indre blødninger (såsom et mavesår) en blødningslidelse, der giver Dem tendens til indre blødning (blødning inde i et af kroppens væv, organer eller led) en nylig alvorlig kvæstelse et nyligt kirurgisk indgreb (gælder også tandoperationer) et planlagt kirurgisk indgreb (gælder også tandoperationer) inden for de næste 7 dage
English: Clopidogrel HEXAL 75 mg film-coated tablets Clopidogrel
Danish: Clopidogrel HEXAL 75 mg filmovertrukne tabletter Clopidogrel
English: What Clopidogrel HEXAL is and what it is used for Before you take Clopidogrel HEXAL How to take Clopidogrel HEXAL Possible side effects
Danish: Det skal De vide, før De begynder at tage Clopidogrel HEXAL Sådan skal De tage Clopidogrel HEXAL Bivirkninger
English: • rare (affects 1 to 10 users in 10,000)
Danish: • Sjælden (påvirker 1 til 10 ud af 10.000 patienter)
English: • uncommon (affects 1 to 10 users in 1,000)
Danish: • Ikke-almindelig (påvirker 1 til 10 ud af 1.000 patienter)
English: Take special care with Clopidogrel HEXAL:
Danish: Vær ekstra forsigtig med at bruge Clopidogrel HEXAL:
English: HOW TO TAKE CLOPIDOGREL HEXAL
Danish: SÅDAN SKAL DE TAGE CLOPIDOGREL HEXAL
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 occlusions) or
Danish: De har fået recept på Clopidogrel HEXAL til forebyggelse af blodpropper og nedsættelse af risikoen for disse alvorlige hændelser, fordi: - De lider af åreforkalkning (også kaldet aterosklerose) - og - De tidligere har haft et hjerteanfald, apopleksi eller en tilstand kaldet perifer arteriel sygdom (kredsløbsforstyrrelser i arme eller ben, forårsaget af vaskulær okklusion), eller - De har haft en alvorlig form for smerter i brystet, som kaldes hjertekrampe (ustabil angina pectoris) eller hjerteanfald (myokardieinfarkt).
English: • common (affects 1 to 10 users in 100)
Danish: • Almindelig (påvirker mellem 1 og 10 ud af 100 patienter)
English: Box 53158-3301 Limassol, Cyprus
Danish: For P. T. Hadjigeorgiou co ltd Postal address: P.O. Box 53158-3301 Limassol, Cyprus
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel HEXAL 75 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Clopidogrel HEXAL 75 mg filmovertrukne tabletter
English: Cellulose, microcrystalline (E460) Crospovidone type A
Danish: Mikrokrystallinsk cellulose (E460)
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel HEXAL 75 mg film-coated tablets Clopidogrel NAME OF THE MARKETING AUTHORISATION HOLDER Acino Pharma GmbH EXPIRY DATE
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Acino Pharma GmbH
English: a recent serious injury a recent surgery (including dental) a planned surgery (including dental) in the next seven days if you have had a clot in an artery of your brain (ischaemic stroke) which occurred within the last seven days if you have kidney or liver disease
Danish: • hvis De har haft en blodprop i en åre (arterie) i hjernen (iskæmisk apopleksi), inden for de seneste 7 dage
English: HOW TO STORE CLOPIDOGREL HEXAL
Danish: Clopidogrel HEXAL.
English: BEFORE YOU TAKE CLOPIDOGREL HEXAL
Danish: DET SKAL DE VIDE, FØR DE BEGYNDER AT TAGE CLOPIDOGREL HEXAL
English: Posology
Danish: Hjælpestoffer
English: Lucentis received a marketing authorisation valid throughout the EU on 22 January 2007.
Danish: Lucentis fik en markedsføringstilladelse med gyldighed i hele EU den 22. januar 2007.
English: All of the patients were over 50 years of age and had not been treated for wet AMD before.
Danish: Alle patienterne var over 50 år og var ikke tidligere blevet behandlet for våd AMD.
English: Further information on Lucentis can be found on the Agency's website:ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Yderligere information om Lucentis findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Other information about Lucentis
Danish: Andre oplysninger om Lucentis
English: The interval between two injections of Lucentis into the same eye must be at least four weeks.
Danish: Intervallet mellem to injektioner af Lucentis i det samme øje skal være på mindst fire uger.
English: As for all medicines, data on the use of Lucentis are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Lucentis løbende overvåget.
English: Treatment with Lucentis should be stopped if the patient is not benefitting from it.
Danish: Behandlingen med Lucentis bør ophøre, hvis patienten ikke har gavn af den.
English: What measures are being taken to ensure the safe and effective use of Lucentis?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Lucentis?
English: The recommended dose for Lucentis is 0.5 mg given as a single intravitreal injection.
Danish: Den anbefalede dosis Lucentis er 0,5 mg, givet som en enkelt intravitreal injektion.
English: The conditions Lucentis is used to treat are:
Danish: Lucentis bruges til at behandle følgende tilstande:
English: Choroidal neovascularisation
Danish: Koroidal neovaskularisering
English: The European Medicines Agency decided that Lucentis'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 Lucentis opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Ranibizumab has been designed to attach to and block a substance called vascular endothelial growth factor A (VEGF-A).
Danish: Ranibizumab er designet til at binde til og blokere et stof, der kaldes vaskulær endotelial vækstfaktor A (VEGF-A).
English: The active substance in Lucentis, ranibizumab, is a small piece of a monoclonal antibody.
Danish: Det aktive stof i Lucentis, ranibizumab, er et lille stykke monoklonalt antistof.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific target (called an antigen) that is found in certain cells in the body.
Danish: Et monoklonalt antistof er en type protein, der er designet til at genkende og binde til et særligt mål (et antigen), som findes i visse celler i kroppen.
English: For more information about using Lucentis, see the package leaflet or contact your doctor or pharmacist
Danish: For mere information om brug af Lucentis, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Side effects reported with Lucentis are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Lucentis vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: An overview of Lucentis and why it is authorised in the EU
Danish: En oversigt over Lucentis, og hvorfor det er godkendt i EU
English: Why is Lucentis authorised in the EU?
Danish: Hvorfor blev Lucentis godkendt i EU?
English: Three main studies of Lucentis involved 1,323 patients with the wet form of AMD.
Danish: Tre hovedstudier af Lucentis omfattede 1 323 patienter med den våde form af AMD.
English: In both studies, the improvement in vision was maintained over the course of the study.
Danish: I begge studier bevaredes synsforbedringen under hele forløbet.
English: Before each injection, a local anaesthetic is given to reduce or prevent any pain from the injection, and the eye, eyelid and skin around the eye are disinfected.
Danish: Før hver injektion gives lokalbedøvelse for at mindske eller forebygge eventuelle smerter ved injektionen, og øjet, øjenlåget og huden omkring øjet desinficeres.
English: • the ‘wet' form of age-related macular degeneration (AMD).
Danish: • den "våde" form af aldersbetinget makuladegeneration (AMD).
English: After one year, between 94 and 96% of the AMD patients receiving Lucentis every month experienced no significant worsening of their vision, compared with 62% of those receiving sham injections and 64% of those treated with verteporfin PDT.
Danish: Efter ét år oplevede mellem 94 % og 96 % af de AMD-patienter, der fik Lucentis hver måned, ingen væsentlige forringelser af synet, sammenholdt med 62 % af dem, der fik skininjektioner, og 64 % af dem, der fik fotodynamisk terapi med verteporfin.
English: What is Lucentis and what is it used for?
Danish: Hvad er Lucentis, og hvad anvendes det til?
English: The most common side effects with Lucentis (seen in more than 1 in 10 patients) are increased intraocular pressure (pressure within the eye), headache, vitritis (inflammation in the eye), vitreous detachment (separation of the vitreous from the back of the eye), retinal haemorrhage (bleeding at the back of the eye), visual disturbance, eye pain, vitreous floaters (spots in the vision), conjunctival haemorrhage (bleeding at the front of the eye), eye irritation, sensation of a foreign body in the eye, increased lacrimation (tear production), blepharitis (inflammation of the eyelids), dry eye, ocular hyperaemia (red eye), eye pruritis (itching), arthralgia (joint pain) and nasopharyngitis (inflammation of the nose and throat).
Danish: De hyppigste bivirkninger ved Lucentis (der kan forekomme hos flere end 1 ud af 10 patienter) er øget tryk i øjet, hovedpine, betændelse i øjet, glaslegemeløsning (forskydning af glaslegemet i den bageste del af øjet), nethindeblødning (blødning bagest i øjet), synsforstyrrelser, øjensmerter, pletter i synsfeltet ("flyvende fluer"), konjunktival blødning (blødning forrest i øjet), øjenirritation, fornemmelsen af at have noget i øjet, øget tåreproduktion, øjenlågsbetændelse, tørre øjne, røde øjne, kløe i øjnene, ledsmerter og betændelse i næse og svælg.
English: In both studies, the main measure of effectiveness was the change in vision in the affected eye, measured by comparing the number of letters that the patient could see at the end of the treatment period with the number before starting treatment.
Danish: I begge studier var det primære mål for virkning ændringen af synet i det pågældende øje målt ved sammenligning af antallet af bogstaver, som patienten kunne se ved behandlingsperiodens afslutning, med antallet inden behandlingsstart.
English: The company that makes Lucentis will provide information packs to patients to help them prepare for Lucentis treatment, recognise serious side effects and know when to seek urgent attention from their doctor.
Danish: Den virksomhed, der markedsfører Lucentis, skal udarbejde informationsmateriale til patienterne, så de kan forberede sig på behandlingen med Lucentis, genkende alvorlige bivirkninger og vide, hvornår de skal søge akut lægehjælp.
English: It can only be obtained with a prescription and must be given by a qualified eye doctor who is experienced in giving intravitreal injections.
Danish: Det udleveres kun efter recept og skal indgives af en øjenlæge med erfaring i intravitreal injektion.
English: What are the risks associated with Lucentis?
Danish: Hvilke risici er der forbundet med Lucentis?
English: The macula provides the vision needed to see detail for everyday tasks such as driving, reading and recognising faces.
Danish: Makula giver det skarpsyn, som man bruger i hverdagen, f.eks. når man fører motorkøretøj, læser og genkender ansigter.
English: • other sight problems associated with choroidal neovascularisation;
Danish: • andre synsforstyrrelser forbundet med koroidal neovaskularisering
English: The patients cannot tell whether they received Lucentis or the sham procedure.
Danish: Patienterne kan ikke mærke, om de har fået Lucentis eller en skininjektionen.
English: VEGF-A is a protein that makes blood vessels grow and leak fluid and blood, damaging the macula.
Danish: VEGF-A er et protein, som får blodkarrene til at vokse og lække væske og blod, der skader den gule plet.
English: Two of the studies compared Lucentis with a sham injection ( a procedure similar to a Lucentis injection, in which the syringe is pressed against the surface of the eye but no actual injection is carried out).
Danish: To af studierne sammenlignede Lucentis-injektion med en skininjektion (en procedure, som svarer til en injektion, hvor injektionssprøjten sættes mod øjets overflade, men hvor der i virkeligheden ikke gives nogen injektion).
English: Lucentis was more effective at improving vision than its comparison treatments.
Danish: Lucentis var mere effektivt til at forbedre synet end sammenligningsbehandlingerne.
English: It is given by intravitreal injection (injection into the vitreous humour, the jelly-like fluid in the eye).
Danish: Det gives ved intravitreal injektion (injektion i glaslegemet, den geléagtige væske i øjet).
English: • macular oedema caused by occlusion (blockage) of the veins behind the retina.
Danish: • makulaødem forårsaget af okklusion (blokering) af venerne bag retina.
English: The third study compared Lucentis with verteporfin photodynamic therapy (PDT, another treatment for AMD).
Danish: I det tredje studie blev Lucentis sammenlignet med fotodynamisk terapi med verteporfin (en anden behandling for AMD).
English: By blocking this factor, ranibizumab reduces the growth of the blood vessels and controls the leakage and swelling.
Danish: Ved at blokere denne faktor mindsker ranibizumab væksten i blodkarrene og begrænser udsivningen og hævelsen.
English: • macular oedema (swelling of the macula) caused by diabetes;
Danish: • makulaødem (hævelse af makula) forårsaget af diabetes
English: Lucentis was more effective at preventing a worsening of vision than the comparison treatment.
Danish: Lucentis var mere effektivt til at forebygge forringelse af synet end sammenligningspræparaterne.
English: The wet form of AMD is caused by choroidal neovascularisation (abnormal growth of blood vessels beneath the retina, which may leak fluid and blood and cause swelling);
Danish: Den våde form af AMD skyldes såkaldt koroidal neovaskularisering (unormal dannelse af blodkar under nethinden, som kan afgive væske og blod og medføre hævelse)
English: For diabetic macular oedema, Lucentis was studied in two main studies involving a total of 454 patients.
Danish: Ved diabetisk makulaødem blev behandling med Lucentis undersøgt i to hovedstudier med i alt 454 patienter.
English: Lucentis is a medicine used to treat adults with certain sight problems caused by damage to the retina (the light-sensing layer at the back of the eye), and more specifically its central region, known as the macula.
Danish: Lucentis er et lægemiddel til behandling af voksne med visse synsforstyrrelser, der skyldes beskadigelse af nethinden (det lysfølsomme lag bagest i øjet), nærmere betegnet dens centrum (der også kaldes makula eller den gule plet).
English: Lucentis was more effective than a sham injection: patients receiving Lucentis at the 0.5 mg dose for six months could see around 11 letters more than patients receiving a sham injection in one study and 14 letters more in the other study.
Danish: Lucentis var mere effektivt end en skininjektion: I det ene studie kunne de patienter, som fik Lucentis i en dosis på 0,5 mg i seks måneder, se ca. 11 bogstaver mere end de patienter, der fik en skininjektion, og 14 bogstaver mere i det andet studie.
English: Treatment with Lucentis is started with one injection every month, with regular checks of the patient's vision and the appearance of the back of the eye, until maximum vision is achieved and/or there are no signs of disease activity; the monitoring and treatment intervals should then be determined by the treating doctor depending on the patient's condition and response.
Danish: Behandlingen med Lucentis indledes med én injektion hver måned, med regelmæssige kontroller af patientens syn og bageste del af øjet, indtil det maksimale syn er nået, og/eller der ikke er tegn på sygdomsaktivitet.
English: The prefilled syringe contains more than the recommended dose, therefore when preparing the injection, the doctor must expel the excess volume and ensure the injection of the correct dose.
Danish: Ved forberedelse af injektionen skal lægen derfor trykke den overskydende mængde ud af sprøjten og sørge for at injicere den korrekte dosis.
English: For choroidal neovascularisation other than that associated with wet AMD, Lucentis has been studied in 2 main studies each lasting a year.
Danish: Ved koroidal neovaskularisering, som ikke er forbundet med våd AMD, er behandling med Lucentis blevet undersøgt i to hovedstudier af hver ét års varighed.
English: A second study involved 178 patients with choroidal neovascularisation associated with other conditions, and compared Lucentis with a sham injection.
Danish: I det andet studie, der omfattede 178 patienter med koroidal neovaskularisering forbundet med andre tilstande, blev Lucentis sammenlignet med en skininjektion.
English: The first study compared Lucentis with a sham injection.
Danish: I det første studie blev Lucentis sammenlignet med en skininjektion.
English: How is Lucentis used?
Danish: Hvordan anvendes Lucentis?
English: For the full list of all side effects of Lucentis, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Lucentis fremgår af indlægssedlen.
English: The main measure of effectiveness was the change in vision in the affected eye after a year of treatment, using a standard eye test with a letter chart.
Danish: Det primære mål for virkning var ændringen af synet på det pågældende øje efter et års behandling, målt ved hjælp af en almindelig synstavle.
English: Macular oedema due to occlusion of retinal veins
Danish: Makulaødem som følge af retinal veneokklusion
English: One study compared Lucentis with verteporfin PDT in 277 patients with choroidal neovascularisation associated with pathologic myopia (a severe type of short sightedness).
Danish: I det ene studie blev Lucentis sammenlignet med verteporfin PDT hos 277 patienter med koroidal neovaskularisering forbundet med patologisk nærsynethed.
English: What benefits of Lucentis have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Lucentis?
English: Lucentis is available as a solution for injection in prefilled syringes or vials, for single use.
Danish: Lucentis fås som injektionsvæske i fyldte sprøjter eller hætteglas til engangsbrug.
English: The second study compared Lucentis, given on its own or as an add-on to laser photocoagulation (a treatment for diabetic macular oedema using a laser), with laser photocoagulation on its own.
Danish: Det andet studie sammenlignede Lucentis givet enten alene eller som tillægsbehandling til laserfotokoagulation (en type laserbehandling) med laserfotokoagulation alene.
English: For macular oedema due to retinal vein occlusion, Lucentis was looked at in two main studies involving a total of 789 patients, where Lucentis was compared with a sham injection.
Danish: Der blev set nærmere på Lucentis til behandling af makulaødem som følge af retinal veneokklusion i to hovedstudier med i alt 789 patienter, hvor Lucentis blev sammenlignet med en skininjektion.
English: Rarely, endophthalmitis (an infection inside the eye), blindness, serious damage to the retina and cataract (clouding of the lens) can occur.
Danish: I sjældne tilfælde kan der opstå betændelse i øjets indre strukturer, blindhed, alvorlig beskadigelse af retina og grå stær (uklarhed i øjets linse).