FrancophonIA/ELRC3.0 huggingface dataset:
English: Each pack of KOGENATE Bayer 1000 IU contains a vial and a pre-filled syringe with a separate plunger rod, as well as a vial adapter, a venipuncture set (for injection into a vein), two alcohol swabs, two dry swabs and two plasters.
Danish: Hver pakning med KOGENATE Bayer 1000 IE indeholder et hætteglas og en fyldt injektionssprøjte med en separat stempelstang samt et forbindelsesstykke til hætteglas, et injektionssæt (til insprøjtning i en blodåre), to sterile spritservietter, to sterile kompresser og to plastre.
English: This summary was last updated in 02-2019.
Danish: Dette sammendrag blev sidst ajourført i 02-2019.
English: Silapo received a marketing authorisation valid throughout the EU on 18 December 2007.
Danish: Silapo fik en markedsføringstilladelse med gyldighed i hele EU den 18. december 2007.
English: Haemoglobin levels were maintained at around 11.4 g/dl in both groups.
Danish: Hæmoglobinniveauerne forblev på omkring 11,4 g/dl i begge grupper.
English: Other information about Silapo:
Danish: Andre oplysninger om Silapo:
English: For these patients, the lowest dose that controls the symptoms well enough should be used.
Danish: Til disse patienter bør der den laveste dosis, som giver tilstrækkelig kontrol med symptomerne, anvendes.
English: The iron levels of all patients should be checked and iron supplements given if necessary.
Danish: Jernindholdet bør kontrolleres hos alle patienter, og der bør om nødvendigt gives jerntilskud.
English: An overview of Silapo and why it is authorised in the EU
Danish: En oversigt over Silapo, og hvorfor det er godkendt i EU
English: This means that Silapo is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Danish: Det betyder, at Silapo i høj grad svarer til et andet biologisk lægemiddel ("referencelægemidlet"), der allerede er godkendt i EU.
English: The most common side effects with Silapo (which may affect more than 1 in 100 people) are headache and increased blood pressure.
Danish: De hyppigste bivirkninger ved Silapo (som optræder hos mere end 1 ud af 100 personer) er hovedpine og forhøjet blodtryk.
English: Further information on Silapo can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/Silapo
Danish: Yderligere information om Silapo findes på agenturets websted under: ema.europa.eu/en/medicines/human/EPAR/Silapo
English: Silapo is a medicine used for the following:
Danish: Silapo er et lægemiddel, der anvendes til:
English: What measures are being taken to ensure the safe and effective use of Silapo?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Silapo?
English: As for all medicines, data on the use of Silapo are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Silapo løbende overvåget.
English: During the last 4 weeks of the study haemoglobin levels were around 11.6 g/dl, having risen from around 8.0 g/dl before treatment.
Danish: I løbet af de sidste 4 uger af studiet var hæmoglobinniveauerne ca. 11,6 g/dl, hvilket var en stigning fra ca. 8,0 g/dl før behandlingen.
English: For more information about using Silapo, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Silapo, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: What is Silapo and what is it used for?
Danish: Hvad er Silapo, og hvad anvendes det til?
English: Side effects reported with Silapo are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Silapo vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: Why is Silapo authorised in the EU?
Danish: Hvorfor blev Silapo godkendt i EU?
English: The dose, how often it is given and how long it is used for also depend on why Silapo is being used and on the patient's bodyweight, and are adjusted according to how well the medicine is working.
Danish: Dosisstørrelse, hvor ofte det gives, og hvor længe det anvendes, afhænger også af, hvad Silapo anvendes til, og af patientens kropsvægt og skal tilpasses, afhængigt af hvor godt lægemidlet virker.
English: What are the risks associated with Silapo?
Danish: Hvilke risici er der forbundet med Silapo?
English: It is used in patients with normal blood iron levels who could experience complications from a blood transfusion, if they do not donate their own blood before surgery and are expected to lose 900 to 1,800 ml of blood;
Danish: Det anvendes til patienter med normalt jernindhold i blodet, hos hvem der vil kunne opstå komplikationer ved blodtransfusion, hvis de ikke inden operationen får tappet blod til eget brug og forventes at miste 900-1 800 ml blod.
English: Silapo is used when patients are at low or intermediate risk of developing acute myeloid leukaemia and have low levels of the natural hormone erythropoietin.
Danish: Silapo anvendes, når patienterne har lav eller mellemstor risiko for at udvikle akut myeloid leukæmi og har et lavt niveau af det naturlige hormon erytropoietin.
English: The injection under the skin may be given by the patient or a carer if they have been trained.
Danish: Injektionen under huden kan indgives af patienterne selv eller en omsorgsperson, hvis denne er blevet instrueret heri.
English: All of the patients in the second study had received treatment with Eprex/Erypo for at least 3 months before they were either switched to Silapo or remained on Eprex/Erypo for 12 weeks.
Danish: Alle patienterne i det andet studie var blevet behandlet med Eprex/Erypo i mindst tre måneder, inden de skiftede over til Silapo eller fortsatte behandlingen med Eprex/Erypo i 12 uger.
English: In these cases, epoetin zeta is used to increase red blood cell counts.
Danish: I disse tilfælde anvendes epoetin zeta til at øge antallet af røde blodlegemer.
English: Silapo contains the active substance epoetin zeta and is a ‘biosimilar' medicine.
Danish: Silapo indeholder det aktive stof epoetin zeta og er et "biosimilært lægemiddel".
English: Silapo can only be obtained with a prescription and treatment must be started under the supervision of a doctor who has experience in the management of patients with the conditions that Silapo is approved for.
Danish: Silapo udleveres kun efter recept, og behandlingen skal iværksættes under tilsyn af en læge, der har erfaring i behandling af patienter med de sygdomme, som Silapo er beregnet til.
English: The company also presented the results of two studies showing that Silapo injected under the skin is as effective as other epoetin medicines: one study involved 261 cancer patients receiving chemotherapy, and the other compared Silapo with Eprex/Erypo in 462 patients with anaemia caused by kidney problems.
Danish: Virksomheden fremlagde også resultaterne af to studier, der viste, at Silapo injiceret under huden er lige så effektivt som andre epoetinlægemidler: et studie omfattede 261 kræftpatienter, der fik kemoterapi, og det andet sammenlignede Silapo med Eprex/Erypo hos 462 patienter med anæmi forårsaget af nyreproblemer.
English: For patients with kidney failure, myelodysplastic syndromes or who are receiving chemotherapy, haemoglobin levels should remain within the recommended range.
Danish: Hos patienter med nyresvigt, myelodysplastiske syndromer, eller som får kemoterapi, bør hæmoglobinniveauerne holdes inden for det anbefalede interval.
English: In patients receiving chemotherapy or with kidney problems, anaemia can be caused by a lack of erythropoietin, or by the body not responding well enough to natural erythropoietin.
Danish: Hos patienter i kemoterapi eller patienter med nyreproblemer kan der opstå anæmi, fordi de mangler erytropoietin, eller fordi kroppen ikke reagerer tilstrækkeligt på det naturlige erytropoietin.
English: • to treat anaemia in adults with myelodysplastic syndromes (conditions in which the production of healthy blood cells is defective).
Danish: at behandle anæmi hos voksne med myelodysplastisk syndrom (tilstand, hvor dannelsen af raske blodlegemer ikke fungerer).
English: The reference medicine for Silapo is Eprex/Erypo, which contains epoetin alfa.
Danish: Referencelægemidlet for Silapo er Eprex/Erypo, som indeholder epoetin alfa.
English: Because Silapo is a biosimilar medicine, the studies on effectiveness and safety of epoetin carried out with Eprex/Erypo do not all need to be repeated for Silapo.
Danish: Da Silapo er et biosimilært lægemiddel, behøver de studier af epoetins virkning og sikkerhed, der er udført for Eprex/Erypo, ikke at blive gentaget for Silapo.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Silapo has a highly similar structure, purity and biological activity to Eprex/Erypo and is distributed in the body in the same way.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Silapo har en struktur, renhed og biologisk aktivitet, der svarer til Eprex'/Erypos, og at det fordeles i kroppen på samme måde.
English: Epoetin zeta is also used before surgery to increase the number of red blood cells and help minimise the consequences of blood loss.
Danish: Epoetin zeta anvendes også forud for en operation til at øge antallet af røde blodlegemer og afbøde virkningerne af blodtab.
English: For the full list of side effects of Silapo, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Silapo fremgår af indlægssedlen.
English: The active substance in Silapo, epoetin zeta, is a copy of a hormone called erythropoietin, and works in the same way as the natural hormone to stimulate the production of red blood cells in the bone marrow.
Danish: Det aktive stof i Silapo, epoetin zeta, er en kopi af det menneskelige hormon erytropoietin og har samme stimulerende virkning på dannelsen af røde blodlegemer i rygmarven som det naturlige hormon.
English: Silapo, injected into a vein, was as effective as Eprex/Erypo in correcting and maintaining red blood cell counts in two main studies involving 922 patients who had anaemia associated with chronic renal failure requiring haemodialysis (a procedure for removing waste products from the blood).
Danish: Silapo injiceret i en vene var ligeså effektivt som Eprex/Erypo til at korrigere og opretholde røde blodlegemer i to hovedstudier, hvori der indgår 922 patienter, der havde anæmi efter langvarig nyresygdom, som nødvendiggjorde behandling med hæmodialyse (en teknik til at fjerne affaldsstoffer fra blodet).
English: Studies have also shown that giving Silapo produces similar levels of the active substance in the body to giving Eprex/Erypo.
Danish: Studier har også vist, at Silapo danner tilsvarende niveauer af det aktive stof i kroppen som Eprex/Erypo.
English: Silapo is available in pre-filled syringes and is injected either into a vein or under the skin, depending on the condition for which the patient is being treated.
Danish: Silapo fås i fyldte sprøjter og indgives som en injektion i en blodåre eller under huden, alt efter hvilken sygdom patienten behandles for.
English: All these data were considered sufficient to conclude that Silapo will behave in the same way as Eprex/Erypo in terms of effectiveness and safety in its authorised uses.
Danish: Disse oplysninger blev anset for tilstrækkelige til at konkludere, at Silapo vil have de samme egenskaber som intravenøs Eprex/Erypo hvad angår sikkerhed og virkning ved de godkendte anvendelser.
English: How is Silapo used?
Danish: Hvordan anvendes Silapo?
English: For more information on biosimilar medicines, see here.
Danish: Der kan indhentes yderligere oplysninger om biosimilære lægemidler, seher.
English: In addition, studies have shown that the effects of the medicine are equivalent to those of Eprex/Erypo in increasing and maintaining blood cell counts in patients with chronic kidney failure or undergoing chemotherapy.
Danish: Desuden har studier vist, at lægemidlet er lige så effektivt som Eprex/Erypo til at øge og fastholde antallet af røde blodlegemer hos patienter, der har kronisk nyresvigt, eller som er i kemoterapi.
English: What benefits of Silapo have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Silapo?
English: Laboratory studies comparing Silapo with Eprex/Erypo have shown that the active substance in Silapo is highly similar to that in Eprex/Erypo in terms of structure, purity and biological activity.
Danish: Laboratoriestudier, der sammenligner Silapo med referencelægemidlet Eprex/Erypo, har vist, at det aktive stof i Silapo svarer til det aktive stof i Eprex/Erypo hvad angår struktur, renhed og biologisk aktivitet.
English: Therefore the Agency's view was that, as for Eprex/Erypo, the benefit of Silapo outweighs the identified risk and it can be authorised.
Danish: Det var derfor agenturets opfattelse, at fordelene ved Silapo opvejer de identificerede risici, som for Eprex/Erypo, og at det kan godkendes.
English: The second study compared the effects of Silapo with those of Eprex/Erypo in maintaining red blood cell counts in 313 patients.
Danish: I det andet studie sammenlignedes Silapos og Eprex'/Erypos evne til at fastholde antallet af røde blodlegemer hos 313 patienter.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Silapo have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Silapo.
English: The first study compared the effects of Silapo with those of Eprex/Erypo in correcting red blood cell counts in 609 patients over 24 weeks.
Danish: I det første studie blev Silapos og Eprex'/Erypos evne til at øge antallet af røde blodlegemer sammenlignet hos 609 patienter i 24 uger.
English: How does Silapo work?
Danish: Hvordan virker Silapo?
English: • patients about to have surgery, including major orthopaedic surgery, and who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke.
Danish: Silapo må ikke anvendes til følgende grupper: patienter, der har fået "pure red cell aplasia" (nedsat eller ophørt dannelse af røde blodlegemer) efter behandling med et epoetin patienter med forhøjet blodtryk, der ikke er velreguleret patienter, der ikke kan få lægemidler til forebyggelse af blodpropper patienter, der skal have foretaget en operation, herunder større ortopædiske operationer, og som har svære hjerte-kar-problemer, herunder nyligt hjerteanfald eller slagtilfælde.
English: • to increase the amount of blood that patients with moderate anaemia can self-donate before surgery, so that their own blood can be given back to them during or after surgery;
Danish: at behandle anæmi (lavt antal røde blodlegemer), som giver symptomer hos patienter med kronisk nyreinsufficiens (langvarig forringelse af nyrernes evne til at fungere, som de skal) eller andre nyreproblemer at behandle anæmi hos voksne, som får kemoterapi for visse kræftformer, og til at mindske behovet for blodtransfusioner at øge den mængde blod, som patienter med moderat anæmi kan give sig selv før en operation, så de kan få deres eget blod tilbage under eller efter operationen at mindske behovet for blodtransfusioner hos voksne med moderat anæmi, som skal gennemgå en større ortopædisk (knogle-) operation, f.eks. hofteoperation.
English: Special warnings and precautions for use Dyskinesia
Danish: Særlige advarsler og forsigtighedsregler vedrørende brugen Dyskinesi
English: Talk to your doctor before taking <product name>.
Danish: Kontakt lægen, før du tager <produktnavn>.
English: Tell your doctor if you have (had) or develop any medical conditions or symptoms, especially any of the following:
Danish: Fortæl det til lægen, hvis du har/har haft eller udvikler medicinske tilstande eller symptomer, navnlig følgende:
English: - Dyskinesia
Danish: - Dyskinesi
English: Pramipexole - Dystonia (EPITT no 18866)
Danish: Pramipexol - dystoni (EPITT nr. 18866)
English: - Dystonia2 (inability of keeping your body and neck straight and upright (axial dystonia)).
Danish: - Dystoni2 (manglende evne til at holde din krop og nakke lige og oprejst (aksial dystoni)).
English: Rare side effects • Increased sensitivity of your skin to sun and ultraviolet light (photosensitivity).
Danish: Sjældne bivirkninger • Øget hudfølsomhed over for sollys og ultraviolet lys (lysfølsomhed).
English: Undesirable effects Skin and subcutaneous tissue disorders Frequency ‘rare': Photosensitivity* *see section c)
Danish: Hud og subkutane væv Hyppighed "sjælden": Lysfølsomhed* * Se punkt c)
English: More severe reactions are reported in patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema.
Danish: Der er indberettet flere svære reaktioner hos patienter med præeksisterende hudlidelser som f.eks. atopisk dermatitis og atopisk eksem.
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/406998/2017
Danish: Ny ordlyd af produktinformation - uddrag af PRAC's anbefalinger vedrørende signaler EMA/PRAC/600978/2017
English: Package leaflet 4.
Danish: Indlægsseddel 4.
English: Adopted at the 29 August-1 September 2017 PRAC
Danish: Vedtaget af PRAC 29. august-1.
English: Mesalazine - Risk of photosensitivity reactions (EPITT no
Danish: Mesalazin - risiko for lysfølsomhedsreaktioner (EPITT nr. 18869)
English: The age and general condition of the patient should also be taken into account.
Danish: Patientens alder og almene tilstand bør ligeledes tages i betragtning.
English: The European Commission issued a decision on this opinion on 22/9/16.
Danish: Europa-Kommissionen traf en afgørelse om denne udtalelse 22/9/16.
English: The patch should be replaced every 3 days.
Danish: Plastret skal skiftes hver 3. dag.
English: These patients should be closely monitored for side effects.
Danish: Sådanne patienter skal overvåges nøje for bivirkninger.
English: The company that markets these medicines is Janssen-Cilag and associated companies.
Danish: Den virksomhed, der markedsfører disse lægemidler, er Janssen-Cilag og tilknyttede virksomheder.
English: The dose should be re-assessed regularly during treatment and the lowest effective dose should be used.
Danish: Dosis skal regelmæssigt på ny vurderes under behandlingen, og der skal vælges den laveste effektive dosis.
English: The CMDh is a medicines regulatory body representing the European Union (EU) Member States, Iceland, Liechtenstein and Norway
Danish: CMDh er en lægemiddelmyndighed, der repræsenterer EU's medlemsstater, Island, Liechtenstein og Norge.
English: Durogesic has been authorised in the EU via national procedures.
Danish: Durogesic er godkendt i EU via nationale procedurer.
English: What is Durogesic?
Danish: Hvad er Durogesic?
English: This section also contains other warnings, including warnings about the risk of respiratory depression, dependence and potential for abuse, and use in children and elderly patients.
Danish: Dette afsnit indeholder også andre advarsler, herunder om risikoen for vejrtrækningsbesvær, afhængighed og muligheden for misbrug, samt anvendelse hos børn og ældre.
English: The Committee also harmonised other sections of the SmPC including sections 4.6 (fertility, pregnancy and lactation), 4.8 (side effects), and 4.9 (overdose).
Danish: Udvalget harmoniserede desuden andre punkter i produktresuméet, herunder punkt 4.6 (Fertilitet, graviditet og amning), 4.8 (Bivirkninger) og 4.9 (Overdosering).
English: The appropriate starting dose should be chosen according to the patient's current use of opioid medicines.
Danish: Startdosis bør vælges svarende til patientens nuværende brug af opioide lægemidler.
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Danish: Dette har ført til afvigelser mellem medlemsstaterne i den måde, lægemidlet kan anvendes på, som det ses af forskellene mellem produktresuméer, etikettering og indlægssedler i de lande, hvor lægemidlet markedsføres.
English: Patients who have serious side effects with Durogesic should be monitored for at least 24 hours after removal of the patch, depending on their symptoms, because the active substance fentanyl remains in the blood for some time and its level only declines slowly (by about half after 24 hours).
Danish: Patienter, som får alvorlige bivirkninger med Durogesic, skal alt efter symptomerne overvåges mindst 24 timer efter fjernelse af plastret, da det aktive stof fentanyl forbliver i blodet i stykke tid, og da koncentrationen kun falder langsomt (til ca. det halve efter 24 timer).
English: Durogesic is available in the EU under various trade names including Durogesic DTrans and Durogesic Matrix.
Danish: Durogesic fås i EU under forskellige handelsnavne, herunder Durogesic DTrans og Durogesic Matrix.
English: On 21 July 2016, the European Medicines Agency completed a review of Durogesic.
Danish: Den 21. juli 2016 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af Durogesic.
English: Therefore, the patches must be kept out of the sight and reach of children, before and after use.
Danish: Plastrene skal derfor opbevares utilgængeligt for børn både før og efter brugen.
English: Why was Durogesic reviewed?
Danish: Hvorfor blev Durogesic vurderet igen?
English: On 15 September 2015, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Durogesic in the EU2.
Danish: Den 15. september 2015 indbragte Europa-Kommissionen sagen for CHMP med henblik på harmonisering af markedsføringstilladelserne for Durogesic i EU2.
English: Also, it must not be used in patients with severe respiratory depression (breathing problems), or in those allergic to fentanyl or any other ingredients of Durogesic.
Danish: Desuden må det ikke bruges hos patienter med svært vejrtrækningsbesvær (respirationsdepression) eller hos patienter, der er allergiske over for fentanyl eller nogen af hjælpestofferne i Durogesic.
English: Fentanyl is an opioid (a pain medicine related to morphine).
Danish: Fentanyl er et smertestillende lægemiddel, der er beslægtet med morphin (et opioid).
English: The use of Durogesic is not recommended in patients who have not taken opioid medicines before.
Danish: Brug af Durogesic frarådes hos patienter, der ikke før har fået opioide lægemidler.
English: 2 This referral procedure did not cover other fentanyl formulations such as tablets, nasal sprays or solutions for injection
Danish: Denne indbringelsesprocedure omfattede ikke andre formuleringer af fentanyl såsom tabletter, næsespray eller injektionsvæske
English: In children treated with Durogesic, the patch should be applied on the upper back to prevent the child from removing the patch.
Danish: Hos børn, der behandles med Durogesic skal plastret anbringes øverst på ryggen for at forhindre barnet i at fjerne det.
English: Having harmonised the indication, the CHMP also harmonised the recommendations on how to use Durogesic.
Danish: Efter harmonisering af anvendelsen (indikationen) harmoniserede CHMP desuden anbefalingerne for brug af Durogesic.
English: It contains the active substance fentanyl and is available as a transdermal patch (a patch that gradually delivers the medicine through the skin).
Danish: Det indeholder det aktive stof fentanyl og leveres som et plaster, der afgiver lægemidlet gennem huden (depotplaster).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Durogesic in the European Union (EU).
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at der er behov for harmonisering af ordineringsoplysningerne for Durogesic i EU.