FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT Bondronat 6 mg concentrate for solution for infusion ibandronic acid
Danish: LÆGEMIDLETS NAVN Bondronat 6 mg koncentrat til infusionsvæske, opløsning
English: angioedema†, anaphylactic reaction/shock†
Danish: Overfølsomhed†, bronkospasme †, angioødem† anafylaktisk reaktion/shock
English: use
Danish: ANVENDELSE
English: If you take more Bondronat than you should
Danish: Hvis du har taget for meget Bondronat
English: Marketing Authorisation Holder Atnahs Pharma Netherlands B.V. Strawinskylaan 3127
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Atnahs Pharma Netherlands B.V.
English: For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) or severe renal impairment (CLcr <30 mL/min) being treated for the prevention of skeletal events in patients with breast cancer and metastatic bone disease the following dosing recommendations should be followed (see section
Danish: For patienter med brystkræft og knoglemetastaser med moderat nedsat nyrefunktion (kreatininclearance ≥ 30 og < 50 ml/min) eller svært nedsat nyrefunktion (kreatininclearance < 30 ml/min), som behandles for at forebygge knoglerelaterede hændelser, skal følgende dosisrekommendationer følges (se pkt.
English: • high levels of urea or high levels of parathyroid hormone in your blood
Danish: • forhøjet koncentration i blodet af urinsyre eller hormoner fra biskjoldbruskkirtlen
English: What Bondronat is and what it is used for What you need to know before you take Bondronat How to take Bondronat
Danish: Det skal du vide, før du begynder at tage Bondronat Sådan skal du tage Bondronat Bivirkninger
English: system in rats (see section 5.2).
Danish: Pædiatrisk population (se pkt.
English: What Bondronat is and what it is used for What you need to know before you receive Bondronat How to receive Bondronat
Danish: Det skal du vide, før du begynder at få Bondronat Sådan får du Bondronat
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRIDUCT
Danish: D. BETINGLESER ELLER BEGRÆNSNINGER VEDRØRENDE SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: Otherwise, some of the medicine could leak back into your food pipe/gullet (oesophagus)
Danish: Hvis du ikke forbliver oprejst, kan noget af medicinen løbe tilbage i spiserøret
English: In reproductive studies in rats by the oral route effects on fertility consisted of increased preimplantation losses at dose levels of 1 mg/kg/day and higher.
Danish: Der fandtes ikke tegn på direkte føtal toksisk eller teratogen effekt af ibandronsyre hos intravenøst behandlede rotter og kaniner I reproduktionsstudier hos rotter var effekten på fertiliteten øget præimplantationstab ved orale doser på 1 mg/kg/døgn og derover.
English: • If you have any further questions, ask your doctor or pharmacist
Danish: • Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide
English: Pharmaceutical Form Route of Administration
Danish: Lægemiddelform Indgivelsesvej Emballage
English: It should not be used in pregnant women.
Danish: Det bør ikke anvendes til gravide
English: This summary was last updated in 02-2007.©EMEA 2007
Danish: Dette sammendrag blev sidst ajourført i 02-2007.©EMEA 2007
English: The marketing authorisation was renewed on 14 February 2002 and 14 February 2007.
Danish: Markedsføringstilladelsen blev forlænget den 14. februar 2002 og den 14. februar 2007.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for LeukoScan to Immunomedics GmbH on 14 February 1997.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for LeukoScan til Immunomedics GmbH den 14. februar 1997.
English: LeukoScan has been studied in two main studies.
Danish: LeukoScan blev undersøgt i to hovedundersøgelser.
English: The radiolabelled solution is given as an intravenous injection, and a scintigraphy is carried out 1 to 8 hours later.
Danish: Den radioaktivt mærkede opløsning gives som en intravenøs injektion, og der udføres en scintigrafi 1 til 8 timer senere.
English: This radiolabelled medicine is for diagnostic use.
Danish: Dette radioaktivt mærkede lægemiddel er til diagnostisk brug.
English: Scintigraphy is a scanning method that uses a special camera (gamma camera) that can detect radioactivity.
Danish: Scintigrafi er en scanningsmetode, der anvender et specielt kamera (gammakamera), der kan påvise radioaktivitet.
English: What is the risk associated with LeukoScan?
Danish: Hvilken risiko er der forbundet med LeukoScan?
English: They recommended that LeukoScan be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for LeukoScan.
English: LeukoScan is not used on its own, but must be radiolabelled before use.
Danish: LeukoScan anvendes ikke alene, men skal radiomærkes inden brug.
English: Because LeukoScan has not been studied in patients aged 21 years or younger, doctors should carefully weigh the benefits and the risks of its use before administering it to a patient in this age group.
Danish: Da LeukoScan ikke er blevet undersøgt hos patienter i alderen 21 år eller derunder, bør lægen omhyggeligt afveje fordele og risici ved brugen af LeukoScan, inden behandlingen gives til en patient i denne aldersgruppe.
English: The full EPAR for LeukoScan is available here.
Danish: Den fuldstændige EPAR om LeukoScan findes her.
English: LeukoScan should not be used in people who may be hypersensitive (allergic) to sulesomab, mouse proteins, or any of the other ingredients.
Danish: LeukoScan bør ikke anvendes til mennesker, der kan være overfølsomme (allergiske) over for sulesomab, museproteiner eller et af de øvrige indholdsstoffer.
English: LeukoScan was more effective than the standard technique of radiolabelled white blood cells, with a higher sensitivity (detection of 88% of the infections with LeukoScan, compared to 73% with the radiolabelled white blood cells).
Danish: LeukoScan var mere effektiv end standardteknikken med radioaktivt mærkede hvide blodlegemer og havde en større følsomhed (påvisning af 88 % af infektionerne med LeukoScan, sammenlignet med 73 % med radioaktivt mærkede hvide blodlegemer).
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found in certain cells in the body.
Danish: Et monoklonalt antistof er et antistof (en slags protein), der er blevet udviklet til at genkende og binde sig til en specifik struktur (som kaldes et antigen), som findes i visse celler i kroppen.
English: When the results of both studies were looked at together, LeukoScan was shown to be as effective in diagnosing bone infections as the biopsy and culture technique.
Danish: Når man sammenlignede resultaterne af begge undersøgelser, viste LeukoScan sig at være lige så effektiv til at diagnosticere knogleinfektioner som biopsi og dyrkningsteknik.
English: The active substance in LeukoScan, sulesomab, is a monoclonal antibody.
Danish: Det aktive stof i LeukoScan, sulesomab, er et monoklonalt antistof.
English: Sulesomab has been designed to target an antigen called NCA90, which is present on the surface of granulocytes (a type of white blood cell).
Danish: Sulesomab er blevet udviklet til at målrette sig mod et antigen, der kaldes NCA90, og som findes på overfladen af granulocytter (en type hvide blodlegemer).
English: Among these 232 patients, 158 had also undergone a scan using a standard scintigraphy technique (when the patient receives a specially prepared injection of their own white blood cells radiolabelled with a suitable radioactive marker).
Danish: Blandt disse 232 patienter havde 158 endvidere fået udført en scanning ved brug af rutinemæssig scintigrafiteknik (hvor patienten får en specielt klargjort injektion af deres egne hvide blodlegemer, der er blevet radioaktivt mærket med en egnet radioaktiv markør).
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part
Danish: Hvis du ønsker yderligere oplysninger om baggrunden for CHMP's anbefalinger, kan du læse de faglige drøftelser (også en del af denne EPAR).
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) LEUKOSCAN EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) LEUKOSCAN
English: Radiolabelled LeukoScan treatment should only be handled and given by someone who is authorised to use radioactive medicines.
Danish: Behandlingen med radioaktivt mærket LeukoScan bør kun udføres af personale, der er autoriseret til at anvende radioaktive lægemidler.
English: How has LeukoScan been studied?
Danish: Hvordan blev LeukoScan undersøgt?
English: Radiolabelling is a technique where a substance is tagged (labelled) with a radioactive compound.
Danish: Radioaktiv mærkning er en teknik, hvor et stof ”mærkes” med et radioaktivt præparat.
English: The main measure of effectiveness was the comparison of the diagnosis made using LeukoScan imaging with the diagnosis from bone biopsy histopathology and microbial culture (when a bone sample is taken and grown in a laboratory to see if it is carrying an infection).
Danish: Det vigtigste mål for effekt var sammenligningen af den diagnose, der blev stillet ved brug af LeukoScan-scanningen, med den diagnose, der blev stillet via histopatologisk undersøgelse af knoglebiopsi og mikrobiel dyrkning (hvor der udtages en knogleprøve, der dyrkes i et laboratorium for at se, om den er bærer af en
English: The Committee for Medicinal products for Human Use (CHMP) decided that LeukoScan's benefits are greater than its risks for determining the location and extent of infection/inflammation in bone in patients with suspected osteomyelitis, including patients with diabetic foot ulcers.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at LeukoScan's fordele er større end risiciene ved bestemmelse af lokalisering og udstrækning af infektion/betændelse i knogler hos patienter med formodet osteomyelitis, herunder patienter med diabetiske fodsår.
English: When LeukoScan is radiolabelled, the radioactive compound technetium-99 (99mTc) becomes attached to sulesomab.
Danish: Når LeukoScan radiomærkes, sætter det radioaktive stof technetium-99 (99mTc) sig fast på sulesomab.
English: LeukoScan is radiolabelled by mixing it with a solution of radioactive technetium (99mTc).
Danish: LeukoScan radiomærkes ved, at det blandes med en opløsning af radioaktivt technetium (99mTc).
English: The second study investigated LeukoScan in 130 patients with suspected long bone osteomyelitis.
Danish: I den anden undersøgelse undersøgtes LeukoScan hos 130 patienter med formodet osteomyelitis i de lange rørknogler.
English: Rare side effects are eosinophilia (increase in eosinophils, a type of white blood cells) and facial rash.
Danish: Sjældne bivirkninger er eosinofili (en stigning i antallet af eosinofiler, der er en type hvide blodlegemer) samt udslæt i ansigtet.
English: When the radiolabelled medicine is injected into the patient, the monoclonal antibody carries the radioactivity to the target antigen on the granulocytes.
Danish: Når det radioaktivt mærkede lægemiddel injiceres i patienten, bærer det monoklonale antistof radioaktiviteten hen til NCA90-antigenet på granulocytterne.
English: LeukoScan is a vial containing a powder to be made into a solution for injection.
Danish: LeukoScan findes i et hætteglas, som indeholder et pulver, der omdannes til en injektionsvæske, opløsning.
English: LeukoScan is used to find the site and extent of infection or inflammation in patients with suspected osteomyelitis (bone infection), including patients
Danish: LeukoScan anvendes til at bestemme lokalisering og udstrækning af infektion og inflammation (betændelse) hos patienter med formodet osteomyelitis (knogleinfektion), herunder patienter med diabetiske fodsår.
English: The first investigated LeukoScan in the detection of osteomyelitis in 102 patients with diabetic foot ulcers.
Danish: I den første undersøgelse så man nærmere på LeukoScans evne til at påvise osteomyelitis hos 102 patienter med diabetiske fodsår.
English: What benefit has LeukoScan shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved LeukoScan?
English: As large numbers of granulocytes gather at the site of an infection, the radioactivity will accumulate where there is an infection, and it can be detected using special scanning techniques, such as scintigraphy or SPECT (single photon emission computed tomography).
Danish: Dette kan vises ved brug af specielle scanningsteknikker, såsom scintigrafi eller SPECT (single photon emission computed tomography).
English: For the full list of all side effects reported with LeukoScan, see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved
English: London, 15 October 2009 EMEA/608943/2009
Danish: London, den 15. oktober 2009 EMEA/608943/2009
English: Marketing Authorisations were granted in 18 Member States of the European Union via different authorisation procedures (mutual recognition procedures or national procedures).
Danish: Der er udstedt markedsføringstilladelser i 18 af Den Europæiske Unions medlemsstater via forskellige godkendelsesprocedurer (gensidige anerkendelsesprocedurer eller nationale procedurer).
English: The final opinion was converted into a Decision by the European Commission on 15 October 2009.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 15.oktober 2009.
English: A revised Opinion, necessitated by purely administrative changes, was adopted by written procedure in July 2009.
Danish: Der blev vedtaget en revideret udtalelse, som var nødvendig på grund af de rent administrative ændringer, ved skriftlig procedure i juli 2009.
English: Tilmicosin is a chemically modified macrolide antibiotic with properties broadly similar to other macrolides.
Danish: Tilmicosin er et kemisk modificeret makrolidantibiotikum med egenskaber, der stort set svarer til andre macrolider.
English: The referral procedure started on 16 September 2008.
Danish: Proceduren for indbragte sager indledtes den 16. september 2008.
English: Due to divergences (i.e. target species, indications for use, withdrawal periods, shelf life and environmental properties) amongst the nationally authorised Summary of Product Characteristics for Pulmotil AC and associated names, Germany referred the matter to the EMEA on 30 July 2008, under Article 34 of Directive 2001/82/EC.
Danish: På grund af forskelle mellem de nationalt godkendte produktresuméer (hvad angår de tilsigtede arter, indikationer for anvendelse, tilbageholdelsesperioder, holdbarhedsperiode og miljømæssige egenskaber) for Pulmotil AC og tilknyttede navne indbragte Tyskland sagen for EMEA den 30. juli 2008 i henhold til artikel 34 i direktiv 2001/82/EF.
English: Based on evaluation of currently available data and the rapporteur's assessment report, the CVMP considered that the benefit/risk profile of Pulmotil AC and associated names is positive subject to the recommended changes to the Summary of Product Characteristics and product information and therefore adopted an Opinion in May 2009 recommending amendments of the Marketing Authorisations.
Danish: På grundlag af vurderingen af de aktuelt foreliggende oplysninger og evalueringsrapporten fra rapportøren var CHMP af den opfattelse, at risk/benefit-forholdet for Pulmotil AC og tilknyttede navne var positivt under forudsætning af de anbefalede ændringer i produktresumeet og produktoplysningerne og vedtog derfor en udtalelse i maj 2009, hvori det anbefalede at markedsføringstilladelserne ændres.
English: Oral explanations were given by the Marketing Authorisation Holder on 15 April 2009
Danish: Indehaveren af markedsføringstilladelsen afgav mundtlige redegørelser den 15. april 2009.
English: OPINION FOLLOWING AN ARTICLE 341 REFERRAL Pulmotil AC and associated names
Danish: Pulmotil AC og tilknyttede navne
English: Pulmotil AC and associated names is a concentrate for oral solution whose active ingredient is tilmicosin with a strength of 250 mg/ml.
Danish: Det aktive stof er tilmicosin med en styrke på 250 mg/ml.
English: Written explanations were provided by the Marketing Authorization Holder on 12 January 2009 and supplementary information was submitted on 16 March 2009.
Danish: Indehaverne af markedsføringstilladelsen fremsendte skriftlige redegørelser den 12. januar 2009.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zontivity on 19 January 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union den 19. januar 2015.
English: This is a summary of the European public assessment report (EPAR) for Zontivity.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Zontivity.
English: The full EPAR and risk management plan summary for Zontivity can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Zontivity findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Zontivity
Danish: Andre oplysninger om Zontivity
English: Nearly all patients also took aspirin and/or another medicine to prevent atherothrombotic events, and were treated for at least a year.
Danish: Næsten alle patienterne fik også aspirin og/eller et andet lægemiddel til at forebygge aterotrombotiske hændelser, og de blev behandlet gennem mindst et år.
English: What measures are being taken to ensure the safe and effective use of Zontivity?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Zontivity?
English: Zontivity is available as tablets (2 mg) and can only be obtained with a prescription.
Danish: Zontivity fås som tabletter (2 mg) og udleveres kun efter recept.
English: For patients who have had a heart attack, treatment with Zontivity should start from 2 weeks after and preferably within one year of the occurrence of the heart attack.
Danish: For patienter, der tidligere har haft et hjerteanfald, bør behandlingen med Zontivity påbegyndes fra 2 uger efter og helst ikke senere end et år efter hjerteanfaldet .
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Zontivity's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Zontivity overstiger risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Zontivity was more effective than placebo at reducing the occurrence of atherothrombotic events.
Danish: Zontivity viste sig at være mere effektivt end placebo til at nedsætte forekomsten af aterotrombotiske hændelser.
English: The most common side effect with Zontivity (which may affect up to 1 in 10 people) is bleeding, particularly nosebleed.
Danish: Den hyppigste bivirkning ved Zontivity (som kan forekomme hos op til 1 ud af 10 personer) er blødning, navnlig næseblødning.
English: It is not intended to provide practical advice on how to use Zontivity.
Danish: Det er ikke en praktisk vejledning i, hvordan Zontivity bør anvendes.
English: For patients with peripheral arterial disease, treatment with Zontivity may be started at any time.
Danish: For patienter med perifer arteriesygdom kan behandlingen påbegyndes når som helst.
English: Vorapaxar blocks the PAR-1 receptors (known as ‘thrombin receptors') on the surface of the platelets.
Danish: Vorapaxar blokerer PAR-1-receptorerne (også kaldet "trombinreceptorerne") på blodpladernes overflade.
English: Why is Zontivity approved?
Danish: Hvorfor blev Zontivity godkendt?
English: What is Zontivity and what is it used for?
Danish: Hvad er Zontivity, og hvad anvendes det til?
English: It therefore considered it appropriate to restrict the use to patients who have not had a stroke.
Danish: Udvalget fandt det derfor hensigtsmæssigt at begrænse brugen til patienter, der ikke har haft et slagtilfælde.
English: Zontivity contains the active substance vorapaxar.
Danish: Zontivity indeholder det aktive stof vorapaxar.
English: What are the risks associated with Zontivity?
Danish: Hvilke risici er der forbundet med Zontivity?
English: The medicine has been shown to be beneficial in reducing the number of atherothrombotic events in patients who had had a heart attack.
Danish: Lægemidlet er påvist at være fordelagtig til at nedsætte antallet af aterotrombotiske hændelser hos patienter, der har haft et hjerteanfald.
English: It must also not be used in patients who have had intracranial haemorrhage (bleeding in the brain) or who are actively bleeding, nor in patients with severely reduced liver function.
Danish: Det må heller ikke anvendes til patienter, der har haft en blødning i kraniet (intrakraniel blødning) eller som bløder aktivt, eller hos patienter med svært nedsat leverfunktion.
English: For more information about treatment with Zontivity, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Zontivity, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Zontivity must not be used together with prasugrel or ticagrelor, two other medicines that help to prevent platelets from sticking together.
Danish: Zontivity må ikke anvendes sammen med prasugrel eller ticagrelor, to andre lægemidler, der bidrager til at forebygge sammenklumpning af blodpladerne.
English: However, as patients with peripheral arterial disease have a high risk of atherothrombotic events and the treatment options for prevention of these events are limited, the CHMP considered that Zontivity's benefits are greater than its risks for this condition.
Danish: Da patienter med perifær arteriesygdom har en høj risiko for aterotrombotiske hændelser, og behandlingsmulighederne for at forebygge disse hændelser er begrænsede, fandt CHMP imidlertid, at fordelene opvejer risiciene for denne sygdom.
English: Thrombin is one of the substances involved in the clotting process, and when it attaches to the PAR-1 receptor it causes the platelets to become ‘sticky', helping the blood clot to form.
Danish: Trombin er et af de stoffer, der medvirker ved størkningsprocessen, og når det bindes til PAR-1 receptoren, bliver blodpladerne "klæbrige", så blodproppen lettere kan dannes.
English: Zontivity was compared with placebo (a dummy treatment) in a main study involving over 26,000 adults who had had a heart attack or other atherothrombotic event or who had peripheral arterial disease.
Danish: Zontivity blev sammenlignet med en virkningsløs behandling (placebo) i en hovedundersøgelse der omfattede over 26 000 voksne, der havde haft et hjerteanfald eller en anden aterotrombotisk hændelse, eller som havde perifer arteriesygdom.
English: In patients with peripheral arterial disease, the data showed a benefit for patients taking Zontivity, although the number of atherothrombotic events reported during the main study was not large enough to enable conclusive results.
Danish: For patienter med perifær arteriesygdom viste dataene en fordel for patienter, der fik Zontivity, selv om antallet af rapporterede aterotrombotiske hændelser ikke var stort nok til at skabe afgørende resultater.
English: Heart attacks and some types of strokes result from blood clots in arteries.
Danish: Årsagen til hjerteanfald nogle typer slagtilfælde er blodpropper i arterierne.
English: Zontivity must not be used in patients who have had a stroke or mini stroke.
Danish: Zontivity må ikke anvendes til patienter, der har haft slagtilfælde eller forbigående slagtilfælde.