FrancophonIA/ELRC3.0 huggingface dataset:
English: Data on concomitant administration of Fendrix with specific hepatitis B immunoglobulin (HBIg) have not been generated.
Danish: Der findes ikke data vedrørende samtidig administration af Fendrix med specifik hepatitis Bimmunoglobulin (HBIg).
English: At month 3, Geometric Mean Titres (GMT) were 223.0 mIU/ml and 50.1 mIU/ml in the Fendrix and control groups respectively, with 41.0% and 15.9% of subjects with anti-HBs antibody titres ≥100 mIU/ml respectively.
Danish: Ved 3. måned var geometrisk-middel-titer (GMT) henholdsvis 223,0 mIE/ml og 50,1 mIE/ml i Fendrix og kontrolgruppen, mens henholdsvis 41,0 % og 15,9 % af personerne havde anti-HB antistoftiter ≥ 100 mIE/ml.
English: At month 7, GMTs were 3559.2 mIU/ml and 933.0 mIU/ml in the Fendrix and control groups who received the commercially available hepatitis B vaccine respectively, with 83.1% and 67.5% of subjects with anti-HBs antibody titres ≥100 mIU/ml respectively.
Danish: Ved 7. måned var GMSs henholdsvis 3559,2 mIE/ml og 933,0 mIE/ml i Fendrix og kontrolgruppen, som modtog en kommercielt tilgængelig hepatitis B-vaccine, mens henholdsvis 83,1 % og 67,5 % af personerne havde anti-HB antistoftiter ≥ 100 mIE/ml.
English: For adjuvants, see section 2.
Danish: Vand til injektionsvæske For adjuvans, se pkt 2.
English: Nervous system disorders: Very common: headache
Danish: Nervesystemet: Meget almindelig: hovedpine
English: Pre-haemodialysis and haemodialysis patients
Danish: Præ-hæmodialyse og hæmodialyse patienter
English: • infection caused by a virus
Danish: • virusinfektion
English: In pre-haemodialysis and haemodialysis patients:
Danish: Præ-hæmodialyse- og hæmodialysepatienter:
English: How to store Fendrix
Danish: Sådan gives Fendrix
English: Muskuloskeletal and connective tissue disorders: Rare: tendinitis, back pain
Danish: Knogler, led, muskler og bindevæv: Sjælden: tendinitis, rygsmerter
English: At month 36, GMTs were 154.1 mIU/ml and 111.9 mIU/ml in the Fendrix and control groups respectively, with 58.7% and 38.5% of subjects with anti-HBs antibody titres ≥100 mIU/ml respectively.
Danish: Ved 36. måned var GMTs henholdsvis 154,1 mIE/ml og 111,9 mIE/ml i Fendrix og kontrolgruppen, mens henholdsvis 58,7 % og 38,5 % af personerne havde anti-HB-antistoftiter ≥ 100 mIE/ml.
English: • Carriers of the virus are likely to get serious liver problems, such as “cirrhosis” or liver cancer.
Danish: • Hepatitis B-smittebærere har risiko for at få alvorlige leversygdomme, f.eks. cirrhose
English: General disorders and administration site conditions: Very common: injection site swelling, fatigue, pain, redness Common: fever
Danish: Almene symptomer og reaktioner på administrationsstedet: Meget almindelig: hævelse på injektionsstedet, træthed, smerte, rødme Almindelig: feber
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Fendrix suspension for injection
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Fendrix injektionsvæske, suspension i.m.
English: Nervous system disorders: Common: headache
Danish: Nervesystemet: Almindelig: hovedpine
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive indholdsstof eller over for et eller flere af hjælpestofferne anført i pkt.
English: General disorders and administration site conditions: Very common: fatigue, pain Common: fever, injection site swelling, redness
Danish: Almene symptomer og reaktioner på administrationsstedet: Meget almindelig: træthed, smerte Almindelig: feber, hævelse på injektionsstedet, rødme
English: Fendrix can also be used as a booster after a course of a different type of hepatitis B vaccine.
Danish: Fendrix kan også anvendes som boosterinjektion efter et fuldendt primært vaccinationsprogram med andre typer hepatitis B-vacciner.
English: Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)
Danish: Fendrix injektionsvæske, suspension Hepatitis B (rDNA)-vaccine (adjuveret, adsorberet)
English: How Fendrix is given How the vaccine is given
Danish: Sådan gives vaccinen
English: Antibody persistence
Danish: Antistof-persistens
English: 10 pre-filled syringes 1 dose (0.5 ml)
Danish: 10 fyldte injektionssprøjter 1 dosis (0,5 ml)
English: Very common (these may occur with more than 1 in 10 doses of the vaccine)
Danish: Meget almindelig (kan forekomme ved flere end 1 ud af 10 vaccinedoser)
English: - Second injection - 1 month after the first injection.
Danish: - på en udvalgt dato i samråd med din læge - Anden injektion - 1 måned efter den første injektion - Tredje injektion
English: • redness or swelling where the injection was given
Danish: • rødme eller hævelse på injektionsstedet
English: 1 pre-filled syringe 1 separate needle 1 dose (0.5 ml)
Danish: 1 fyldt injektionssprøjte 1 separat kanyle 1 dosis (0,5 ml)
English: NAME OF THE MEDICINAL PRODUCT Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).
Danish: LÆGEMIDLETS NAVN Fendrix injektionsvæske, suspension Hepatitis B (rDNA)-vaccine (adjuveret, adsorberet).
English: NAME OF THE MEDICINAL PRODUCT Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)
Danish: LÆGEMIDLETS NAVN Fendrix injektionsvæske, suspension Hepatitis B (rDNA)-vaccine (adjuveret, adsorberet)
English: Rare (these may occur with up to 1 in 1,000 doses of the vaccine)
Danish: Sjælden (kan forekomme ved op til 1 ud af 1.000 vaccinedoser)
English: - Fourth injection - 6 months after the first injection.
Danish: - 6 måneder efter den første injektion
English: • chills
Danish: • kramper
English: 1 pre-filled syringe 1 dose (0.5 ml)
Danish: 1 fyldt injektionssprøjte 1 dosis (0,5 ml)
English: Uncommon (these may occur with up to 1 in 100 doses of the vaccine)
Danish: Ikke almindelig (kan forekomme ved op til 1 ud af 100 vaccinedoser)
English: The following information is intended for healthcare professionals only: Upon storage, a fine white deposit with a clear colourless supernatant can be observed.
Danish: 6.6 Regler for bortskaffelse og anden håndtering Efter opbevaring kan et fint hvidt bundfald med en klar farveløs supernatant observeres.
English: Common (these may occur with up to 1 in 10 doses of the vaccine)
Danish: Almindelig (kan forekomme ved op til 1 ud af 10 vaccinedoser)
English: Very rare (these may occur with up to 1 in 10,000 doses of the vaccine)
Danish: Meget sjælden (kan forekomme ved færre end 1 ud af 10.000 vaccinedoser)
English: Fendrix should not be given to subjects suffering from acute severe febrile illness.
Danish: Fendrix må ikke gives til personer, der har vist sig overfølsomme for andre hepatitis B-vacciner Fendrix må ikke gives til personer med akut alvorlig febril lidelse.
English: What Fendrix looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: PREFILLED SYRINGE
Danish: • forstyrrelser i synsnerven
English: List of adverse reactions
Danish: Liste over bivirkninger
English: Abseamed received a marketing authorisation valid throughout the EU on 28 August 2007.
Danish: Abseamed fik en markedsføringstilladelse med gyldighed i hele EU den 28. august 2007.
English: Abseamed must not be used in the following groups:
Danish: Abseamed må ikke anvendes til følgende grupper:
English: Further information on Abseamed can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Yderligere information om Abseamed findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The iron levels of all patients should be checked to make sure that they are not too low, and iron supplements given if necessary.
Danish: Jernindholdet bør kontrolleres hos alle patienter for at sikre, at det ikke er for lavt, og der bør om nødvendigt gives jerntilskud.
English: Other information about Abseamed
Danish: Andre oplysninger om Abseamed
English: This means that Abseamed is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Danish: Det betyder, at Abseamed i høj grad svarer til et andet biologisk lægemiddel ("referencelægemidlet"), der allerede er godkendt i EU.
English: As for all medicines, data on the use of Abseamed are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Abseamed løbende overvåget.
English: An overview of Abseamed and why it is authorised in the EU
Danish: En oversigt over Abseamed, og hvorfor det er godkendt i EU
English: Flu-like illness may occur especially at the start of treatment.
Danish: Der kan opstå influenzalignende symptomer, navnlig ved behandlingens start.
English: What measures are being taken to ensure the safe and effective use of Abseamed?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Abseamed?
English: Abseamed is a medicine used for the following:
Danish: Abseamed er et lægemiddel, der anvendes til:
English: What is Abseamed and what is it used for?
Danish: Hvad er Abseamed, og hvad anvendes det til?
English: The most common side effects with Abseamed (which may affect more than 1 in 10 people) are nausea (feeling sick), diarrhoea, vomiting, fever and headache.
Danish: De hyppigste bivirkninger ved Abseamed (der kan forekomme hos mere end 1 ud af 10 patienter) er kvalme, diarré, opkastning, feber og hovedpine.
English: When Abseamed is used for autologous blood transfusion, the restrictions normally associated with this type of transfusion should be observed.
Danish: Når Abseamed anvendes til autolog blodtransfusion, skal de begrænsninger, der normalt gælder for denne form for transfusion, overholdes.
English: Side effects reported with Abseamed are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Abseamed vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: following treatment with any erythropoietin;
Danish: efter behandling med et erytropoietin
English: For more information about using Abseamed, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Abseamed, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: For these patients, the lowest dose that provides adequate control of symptoms should be used.
Danish: Den laveste dosis, som giver tilstrækkelig kontrol med symptomerne, bør anvendes hos disse patienter.
English: Why is Abseamed authorised in the EU?
Danish: Hvorfor blev Abseamed godkendt i EU?
English: What are the risks associated with Abseamed?
Danish: Hvilke risici er der forbundet med Abseamed?
English: For patients with chronic kidney failure, myelodysplastic syndromes, or receiving chemotherapy, haemoglobin levels should remain within the recommended range (between 10 and 12 grams per decilitre in adults and between 9.5 and 11 g/dl in children).
Danish: Hos patienter med kronisk nyresvigt, myelodysplastisk syndrom og patienter i kemoterapi bør hæmoglobinniveauet holdes inden for det anbefalede interval (10-12 g/dl hos voksne og 9,5-11 g/dl hos børn).
English: • patients who have developed pure red cell aplasia (reduced or stopped red blood cell production)
Danish: • patienter, der har fået "pure red cell aplasia" (nedsat eller ophørt dannelse af røde blodlegemer)
English: Abseamed contains the active substance epoetin alfa and is a ‘biosimilar medicine'.
Danish: Abseamed indeholder det aktive stof epoetin alfa og er et "biosimilært lægemiddel".
English: Abseamed 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: Abseamed 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: • patients with high blood pressure that is not controlled;
Danish: • patienter med forhøjet blodtryk, der ikke er velreguleret
English: The main measure of effectiveness was the change in the levels of haemoglobin between the start of the study and the evaluation period, between weeks 25 and 29.
Danish: Virkningen blev hovedsagelig målt på ændringen i blodets indhold af hæmoglobin fra studiets start til vurderingsperioden, dvs. fra uge 25 til 29.
English: Abseamed, injected into a vein, was compared with the reference medicine in one main study involving 479 patients with anaemia caused by kidney problems.
Danish: Abseamed injiceret i en blodåre blev sammenlignet med referencelægemidlet i et hovedstudie, som omfattede 479 patienter med anæmi forårsaget af nyreproblemer.
English: • patients undergoing surgery who cannot receive medicines for the prevention of blood clots;
Danish: • patienter, der gennemgår kirurgiske indgreb, og som ikke må få lægemidler til forebyggelse af blodpropper
English: How is Abseamed used?
Danish: Hvordan anvendes Abseamed?
English: In these cases, epoetin alfa is used to increase red blood cell counts.
Danish: I disse tilfælde anvendes epoetin alfa til at øge antallet af røde blodlegemer.
English: Abseamed is available in pre-filled syringes of various strengths and is given as an injection into a vein or as an injection under the skin, depending on the condition for which the patient is being treated.
Danish: Abseamed fås i fyldte sprøjter med forskellig styrke og indgives som injektion i en blodåre eller som injektion under huden, alt efter hvilken sygdom patienten behandles for.
English: The reference medicine for Abseamed is Eprex/Erypo.
Danish: Referencelægemidlet for Abseamed er Eprex/Erypo.
English: • to treat anaemia in adults receiving chemotherapy for certain types of cancer and to reduce the need for blood transfusions;
Danish: • behandling af anæmi hos voksne, som får kemoterapi for visse former for kræft, og til nedsættelse af behovet for blodtransfusioner
English: All of the patients had been receiving Eprex/Erypo injected into a vein for at least 8 weeks before they were either switched to Abseamed or remained on Eprex/Erypo.
Danish: Alle patienterne havde fået Eprex/Erypo som injektion i en blodåre i mindst 8 uger, inden de enten skiftede til Abseamed eller fortsatte med Eprex/Erypo.
English: Abseamed 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 Abseamed is used for.
Danish: Abseamed udleveres kun efter recept, og behandlingen skal iværksættes under tilsyn af en læge, der har erfaring i behandling af patienter med de sygdomme, som Abseamed er beregnet til.
English: • patients about to undergo major orthopaedic surgery who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke.
Danish: • patienter, der skal have foretaget større ortopædkirurgiske indgreb, og som har alvorlige hjerte kar-problemer, herunder nyligt hjerteanfald eller slagtilfælde.
English: Because Abseamed is a biosimilar medicine, the studies on effectiveness and safety of epoetin alfa carried out with Eprex/Erypo do not all need to be repeated for Abseamed.
Danish: Da Abseamed er et biosimilært lægemiddel, behøver de studier af epoetin alfas virkning og sikkerhed, der er udført for Eprex/Erypo, ikke at blive gentaget for Abseamed.
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: Abseamed 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 som forventes at miste 9001.800 ml blod.
English: • to increase the amount of blood that can be taken in adult patients with moderate anaemia and normal blood iron levels who are going to have an operation and donate their own blood before surgery (autologous blood transfusion);
Danish: • at øge mængden af blod, som kan tappes hos voksne patienter med moderat anæmi og normalt jernindhold i blodet, der skal opereres, og som skal donere deres eget blod inden det kirurgiske indgreb (autolog blodtransfusion)
English: • to treat anaemia in adults with myelodysplastic syndromes (conditions in which the production of healthy blood cells is defective).
Danish: • behandling af anæmi hos voksne med myelodysplastisk syndrom (tilstand, hvor dannelsen af raske blodlegemer er nedsat).
English: Epoetin alfa is also used before surgery to increase the number of red blood cells and help minimise the consequences of blood loss.
Danish: Epoetin alfa anvendes også forud for et kirurgisk indgreb til at øge antallet af røde blodlegemer og afbøde virkningerne af blodtab.
English: • to treat anaemia (low red blood cell counts) that is causing symptoms in patients with chronic kidney failure (long-term, progressive decrease in the ability of the kidneys to work properly) or other kidney problems;
Danish: • behandling af anæmi (lavt antal røde blodlegemer), som giver symptomer hos patienter med kronisk nyresvigt (langvarig, fremadskridende nedsættelse af nyrefunktionen) eller andre nyreproblemer
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Abseamed 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 Abseamed har en struktur, renhed og biologisk aktivitet, der svarer til Eprex/Erypos, og at det fordeles i kroppen på samme måde.
English: The active substance in Abseamed, epoetin alfa, is a copy of a hormone called erythropoietin, and works in exactly the same way as the natural hormone to stimulate the production of red blood cells in the bone marrow.
Danish: Det aktive stof i Abseamed, epoetin alfa, er en kopi af det menneskelige hormon erytropoietin og har nøjagtigt samme stimulerende virkning på dannelsen af røde blodlegemer i rygmarven som det naturlige hormon.
English: Patients switching to Abseamed maintained haemoglobin levels to the same extent as those continuing with Eprex/Erypo.
Danish: Patienter, der skiftede til Abseamed, fastholdt niveauet af hæmoglobin i samme omfang som dem, der fortsatte med Eprex/Erypo.
English: For the full list of side effects of Abseamed, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Abseamed fremgår af indlægssedlen.
English: What benefits of Abseamed have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Abseamed?
English: • to reduce the need for blood transfusions in adults with moderate anaemia who are about to undergo major orthopaedic (bone) surgery, such as hip surgery.
Danish: • at mindske behovet for blodtransfusioner hos voksne med moderat anæmi, som skal gennemgå større ortopædkirurgiske indgreb, f.eks. hofteoperation.
English: Laboratory studies comparing Abseamed with the reference medicine Eprex/Erypo have shown that the active substance in Abseamed is highly similar to that in Eprex/Erypo in terms of structure, purity and biological activity.
Danish: Laboratoriestudier, der sammenligner Abseamed med referencelægemidlet Eprex/Erypo, har vist, at det aktive stof i Abseamed 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 Abseamed outweighs the identified risk and it can be authorised.
Danish: Det var derfor agenturets opfattelse, at fordelene ved Abseamed opvejer de identificerede risici, som for Eprex/Erypo, og at det kan godkendes.
English: Studies have also shown that giving Abseamed produces similar levels of the active substance in the body to giving Eprex/Erypo.
Danish: Studier har også vist, at indgivelse af Abseamed giver samme niveau af det aktive stof i kroppen som indgivelse af Eprex/Erypo.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Abseamed 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 Abseamed.
English: In addition, Abseamed was shown to be as effective as Eprex/Erypo at increasing and maintaining red blood cell counts in several studies.
Danish: Desuden er det i adskillige studier påvist, at Abseamed er lige så effektivt som Eprex/Erypo til at øge og fastholde antallet af røde blodlegemer.
English: A further study showed that Abseamed was safe and effective when given under the skin in 416 patients with chronic kidney failure.
Danish: Et yderligere studie hos 416 patienter med kronisk nyresvigt viste, at Abseamed var sikkert og effektivt, når det blev injiceret under huden.
English: Another study showed that Abseamed injected under the skin was as effective in maintaining haemoglobin levels as Eprex/Erypo in 114 cancer patients who were receiving chemotherapy.
Danish: Et andet studie hos 114 kræftpatienter, som var i kemoterapi, viste, at Abseamed injiceret under huden var lige så effektivt som Eprex/Erypo til at fastholde hæmoglobinniveauet.
English: The dose, the frequency of injection and how long it is used for also depend on why Abseamed is being used and on the patient's bodyweight, and are adjusted according to how well the medicine is working.
Danish: Injektionen under huden kan indgives af patienterne selv eller deres omsorgspersoner, hvis de har lært at gøre det. Dosen, injektionshyppigheden og behandlingsvarigheden beregnes ud fra, hvad Abseamed anvendes til og hvor meget patienten vejer, og skal desuden tilpasses patientens respons.
English: How does Abseamed work?
Danish: Hvordan virker Abseamed?
English: --1 Equine influenza virus strains: A/equine-2/South Africa/4/03 strain
Danish: --1 Equin influenzavirus stammer: A/equine-2/Sydafrika/4/03 stamme
English: Vial (type I glass) closed with a halogenobutyl rubber stopper and aluminium cap
Danish: Intramuskulær Hætteglas (Type I glas) lukket med en halogenobutyl gummiprop og aluminiumshætte.
English: 40 Lf/ml
Danish: ≥ 30 IE/ml
English: A/equine-2/Newmarket/2/93 strain
Danish: A/equine-2/Newmarket/2/93 stamme 50 AE/ml Tetanus toksoid
English: List of the names, pharmaceutical form, strength of the medicinal product, route of administration, applicant / marketing authorisation holder in the Member States
Danish: Fortegnelse over lægemidlernes navne, lægemiddelform, styrke, indgivelsesvej, ansøger/indehaver af markedsføringstilladelse i Medlemsstaterne
English: The application was submitted to Ireland as reference Member State and Austria, Bulgaria, Denmark, Spain, Finland, France, Hungary, the Netherlands, Poland, Portugal, Romania, Sweden, Slovenia as concerned Member States, as well as Iceland and Norway.
Danish: Ansøgningen blev indgivet i Irland, som var referencemedlemsstat, og de berørte medlemsstater var Østrig, Bulgarien, Danmark, Spanien, Finland, Frankrig, Ungarn, Nederlandene, Polen, Portugal, Rumænien, Sverige og Slovenien samt Island og Norge.
English: The applicant, Pfizer Limited, has submitted an application for a decentralised procedure for the above mentioned veterinary medicinal product in the framework of Article 32 of Directive 2001/82/EC, as amended.
Danish: Ansøgeren, Pfizer Limited, har indgivet en ansøgning efter den decentrale procedure for ovennævnte veterinærlægemiddel i henhold til artikel 32 i direktiv 2001/82/EØF, som ændret.
English: Potential serious risks were identified during the decentralised procedure by two concerned Member States regarding the environmental risk assessment (the Netherlands and France).
Danish: Under den decentrale procedure påpegede to berørte medlemsstater (Nederlandene og Frankrig) potentielle alvorlige risici vedrørende miljørisikovurderingen.