natgillin/translations-raw huggingface dataset:
50 mikrogram2adsorberet på aluminiumphosphat (0,5 milligram Al3+ totalt) 3produceret på gærceller (Saccharomyces cerevisiae) ved hjælp af rekombinant DNA-teknologi.
2adsorbed on aluminium phosphate (0.5 milligrams Al3+ in total) 3produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology.
Primært vaccinationsprogram:
Primary immunisation:
Der findes ikke data vedrørende samtidig administration af Fendrix med specifik hepatitis Bimmunoglobulin (HBIg).
Data on concomitant administration of Fendrix with specific hepatitis B immunoglobulin (HBIg) have not been generated.
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.
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.
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.
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.
Vand til injektionsvæske For adjuvans, se pkt 2.
For adjuvants, see section 2.
Nervesystemet: Meget almindelig: hovedpine
Nervous system disorders: Very common: headache
Præ-hæmodialyse og hæmodialyse patienter
Pre-haemodialysis and haemodialysis patients
• virusinfektion
• infection caused by a virus
Præ-hæmodialyse- og hæmodialysepatienter:
In pre-haemodialysis and haemodialysis patients:
Sådan gives Fendrix
How to store Fendrix
Knogler, led, muskler og bindevæv: Sjælden: tendinitis, rygsmerter
Muskuloskeletal and connective tissue disorders: Rare: tendinitis, back pain
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.
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.
• Hepatitis B-smittebærere har risiko for at få alvorlige leversygdomme, f.eks. cirrhose
• Carriers of the virus are likely to get serious liver problems, such as “cirrhosis” or liver cancer.
Almene symptomer og reaktioner på administrationsstedet: Meget almindelig: hævelse på injektionsstedet, træthed, smerte, rødme Almindelig: feber
General disorders and administration site conditions: Very common: injection site swelling, fatigue, pain, redness Common: fever
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Fendrix injektionsvæske, suspension i.m.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Fendrix suspension for injection
Nervesystemet: Almindelig: hovedpine
Nervous system disorders: Common: headache
Overfølsomhed over for det aktive indholdsstof eller over for et eller flere af hjælpestofferne anført i pkt.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Almene symptomer og reaktioner på administrationsstedet: Meget almindelig: træthed, smerte Almindelig: feber, hævelse på injektionsstedet, rødme
General disorders and administration site conditions: Very common: fatigue, pain Common: fever, injection site swelling, redness
Fendrix kan også anvendes som boosterinjektion efter et fuldendt primært vaccinationsprogram med andre typer hepatitis B-vacciner.
Fendrix can also be used as a booster after a course of a different type of hepatitis B vaccine.
Fendrix injektionsvæske, suspension Hepatitis B (rDNA)-vaccine (adjuveret, adsorberet)
Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)
Sådan gives vaccinen
How Fendrix is given How the vaccine is given
Antistof-persistens
Antibody persistence
10 fyldte injektionssprøjter 1 dosis (0,5 ml)
10 pre-filled syringes 1 dose (0.5 ml)
Meget almindelig (kan forekomme ved flere end 1 ud af 10 vaccinedoser)
Very common (these may occur with more than 1 in 10 doses of the vaccine)
- på en udvalgt dato i samråd med din læge - Anden injektion - 1 måned efter den første injektion - Tredje injektion
- Second injection - 1 month after the first injection.
• rødme eller hævelse på injektionsstedet
• redness or swelling where the injection was given
1 fyldt injektionssprøjte 1 separat kanyle 1 dosis (0,5 ml)
1 pre-filled syringe 1 separate needle 1 dose (0.5 ml)
LÆGEMIDLETS NAVN Fendrix injektionsvæske, suspension Hepatitis B (rDNA)-vaccine (adjuveret, adsorberet).
NAME OF THE MEDICINAL PRODUCT Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).
LÆGEMIDLETS NAVN Fendrix injektionsvæske, suspension Hepatitis B (rDNA)-vaccine (adjuveret, adsorberet)
NAME OF THE MEDICINAL PRODUCT Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)
Sjælden (kan forekomme ved op til 1 ud af 1.000 vaccinedoser)
Rare (these may occur with up to 1 in 1,000 doses of the vaccine)
- 6 måneder efter den første injektion
- Fourth injection - 6 months after the first injection.
• kramper
• chills
1 fyldt injektionssprøjte 1 dosis (0,5 ml)
1 pre-filled syringe 1 dose (0.5 ml)
Ikke almindelig (kan forekomme ved op til 1 ud af 100 vaccinedoser)
Uncommon (these may occur with up to 1 in 100 doses of the vaccine)
6.6 Regler for bortskaffelse og anden håndtering Efter opbevaring kan et fint hvidt bundfald med en klar farveløs supernatant observeres.
The following information is intended for healthcare professionals only: Upon storage, a fine white deposit with a clear colourless supernatant can be observed.
Almindelig (kan forekomme ved op til 1 ud af 10 vaccinedoser)
Common (these may occur with up to 1 in 10 doses of the vaccine)
Meget sjælden (kan forekomme ved færre end 1 ud af 10.000 vaccinedoser)
Very rare (these may occur with up to 1 in 10,000 doses of the vaccine)
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.
Fendrix should not be given to subjects suffering from acute severe febrile illness.
Udseende og pakningsstørrelser
What Fendrix looks like and contents of the pack
• forstyrrelser i synsnerven
PREFILLED SYRINGE
Liste over bivirkninger
List of adverse reactions
Abseamed fik en markedsføringstilladelse med gyldighed i hele EU den 28. august 2007.
Abseamed received a marketing authorisation valid throughout the EU on 28 August 2007.
Abseamed må ikke anvendes til følgende grupper:
Abseamed must not be used in the following groups:
Yderligere information om Abseamed findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Further information on Abseamed can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Jernindholdet bør kontrolleres hos alle patienter for at sikre, at det ikke er for lavt, og der bør om nødvendigt gives jerntilskud.
The iron levels of all patients should be checked to make sure that they are not too low, and iron supplements given if necessary.
Andre oplysninger om Abseamed
Other information about Abseamed
Det betyder, at Abseamed i høj grad svarer til et andet biologisk lægemiddel ("referencelægemidlet"), der allerede er godkendt i EU.
This means that Abseamed is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Som for alle lægemidler bliver data vedrørende brug af Abseamed løbende overvåget.
As for all medicines, data on the use of Abseamed are continuously monitored.
En oversigt over Abseamed, og hvorfor det er godkendt i EU
An overview of Abseamed and why it is authorised in the EU
Der kan opstå influenzalignende symptomer, navnlig ved behandlingens start.
Flu-like illness may occur especially at the start of treatment.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Abseamed?
What measures are being taken to ensure the safe and effective use of Abseamed?
Abseamed er et lægemiddel, der anvendes til:
Abseamed is a medicine used for the following:
Hvad er Abseamed, og hvad anvendes det til?
What is Abseamed and what is it used for?
De hyppigste bivirkninger ved Abseamed (der kan forekomme hos mere end 1 ud af 10 patienter) er kvalme, diarré, opkastning, feber og hovedpine.
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.
Når Abseamed anvendes til autolog blodtransfusion, skal de begrænsninger, der normalt gælder for denne form for transfusion, overholdes.
When Abseamed is used for autologous blood transfusion, the restrictions normally associated with this type of transfusion should be observed.
Bivirkninger rapporteret for Abseamed vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Abseamed are carefully evaluated and any necessary action taken to protect patients.
efter behandling med et erytropoietin
following treatment with any erythropoietin;
For mere information om brug af Abseamed, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
For more information about using Abseamed, see the package leaflet or contact your doctor or pharmacist.
Den laveste dosis, som giver tilstrækkelig kontrol med symptomerne, bør anvendes hos disse patienter.
For these patients, the lowest dose that provides adequate control of symptoms should be used.
Hvorfor blev Abseamed godkendt i EU?
Why is Abseamed authorised in the EU?
Hvilke risici er der forbundet med Abseamed?
What are the risks associated with Abseamed?
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).
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).
• patienter, der har fået "pure red cell aplasia" (nedsat eller ophørt dannelse af røde blodlegemer)
• patients who have developed pure red cell aplasia (reduced or stopped red blood cell production)
Abseamed indeholder det aktive stof epoetin alfa og er et "biosimilært lægemiddel".
Abseamed contains the active substance epoetin alfa and is a ‘biosimilar medicine'.
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.
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.
• patienter med forhøjet blodtryk, der ikke er velreguleret
• patients with high blood pressure that is not controlled;
Virkningen blev hovedsagelig målt på ændringen i blodets indhold af hæmoglobin fra studiets start til vurderingsperioden, dvs. fra uge 25 til 29.
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.
Abseamed injiceret i en blodåre blev sammenlignet med referencelægemidlet i et hovedstudie, som omfattede 479 patienter med anæmi forårsaget af nyreproblemer.
Abseamed, injected into a vein, was compared with the reference medicine in one main study involving 479 patients with anaemia caused by kidney problems.
• patienter, der gennemgår kirurgiske indgreb, og som ikke må få lægemidler til forebyggelse af blodpropper
• patients undergoing surgery who cannot receive medicines for the prevention of blood clots;
Hvordan anvendes Abseamed?
How is Abseamed used?
I disse tilfælde anvendes epoetin alfa til at øge antallet af røde blodlegemer.
In these cases, epoetin alfa is used to increase red blood cell counts.
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.
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.
Referencelægemidlet for Abseamed er Eprex/Erypo.
The reference medicine for Abseamed is Eprex/Erypo.
• behandling af anæmi hos voksne, som får kemoterapi for visse former for kræft, og til nedsættelse af behovet for blodtransfusioner
• to treat anaemia in adults receiving chemotherapy for certain types of cancer and to reduce the need for blood transfusions;
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.
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.
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.
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.
• patienter, der skal have foretaget større ortopædkirurgiske indgreb, og som har alvorlige hjerte kar-problemer, herunder nyligt hjerteanfald eller slagtilfælde.
• patients about to undergo major orthopaedic surgery who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke.
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.
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.
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.
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;
• 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)
• 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);
• behandling af anæmi hos voksne med myelodysplastisk syndrom (tilstand, hvor dannelsen af raske blodlegemer er nedsat).
• to treat anaemia in adults with myelodysplastic syndromes (conditions in which the production of healthy blood cells is defective).
Epoetin alfa anvendes også forud for et kirurgisk indgreb til at øge antallet af røde blodlegemer og afbøde virkningerne af blodtab.
Epoetin alfa is also used before surgery to increase the number of red blood cells and help minimise the consequences of blood loss.
• behandling af anæmi (lavt antal røde blodlegemer), som giver symptomer hos patienter med kronisk nyresvigt (langvarig, fremadskridende nedsættelse af nyrefunktionen) eller andre nyreproblemer
• 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;
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.
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.
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.
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.
Patienter, der skiftede til Abseamed, fastholdt niveauet af hæmoglobin i samme omfang som dem, der fortsatte med Eprex/Erypo.
Patients switching to Abseamed maintained haemoglobin levels to the same extent as those continuing with Eprex/Erypo.
Den fuldstændige liste over bivirkninger ved Abseamed fremgår af indlægssedlen.
For the full list of side effects of Abseamed, see the package leaflet.
Hvilke fordele viser studierne, at der er ved Abseamed?
What benefits of Abseamed have been shown in studies?
• at mindske behovet for blodtransfusioner hos voksne med moderat anæmi, som skal gennemgå større ortopædkirurgiske indgreb, f.eks. hofteoperation.
• 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.
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.
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.
Det var derfor agenturets opfattelse, at fordelene ved Abseamed opvejer de identificerede risici, som for Eprex/Erypo, og at det kan godkendes.
Therefore the Agency's view was that, as for Eprex/Erypo, the benefit of Abseamed outweighs the identified risk and it can be authorised.
Studier har også vist, at indgivelse af Abseamed giver samme niveau af det aktive stof i kroppen som indgivelse af Eprex/Erypo.
Studies have also shown that giving Abseamed produces similar levels of the active substance in the body to giving Eprex/Erypo.
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.
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.
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.
In addition, Abseamed was shown to be as effective as Eprex/Erypo at increasing and maintaining red blood cell counts in several studies.
Et yderligere studie hos 416 patienter med kronisk nyresvigt viste, at Abseamed var sikkert og effektivt, når det blev injiceret under huden.
A further study showed that Abseamed was safe and effective when given under the skin in 416 patients with chronic kidney failure.
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.
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.
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.
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.
Hvordan virker Abseamed?
How does Abseamed work?
--1 Equin influenzavirus stammer: A/equine-2/Sydafrika/4/03 stamme
--1 Equine influenza virus strains: A/equine-2/South Africa/4/03 strain
Intramuskulær Hætteglas (Type I glas) lukket med en halogenobutyl gummiprop og aluminiumshætte.
Vial (type I glass) closed with a halogenobutyl rubber stopper and aluminium cap
≥ 30 IE/ml
40 Lf/ml
A/equine-2/Newmarket/2/93 stamme 50 AE/ml Tetanus toksoid
A/equine-2/Newmarket/2/93 strain
Fortegnelse over lægemidlernes navne, lægemiddelform, styrke, indgivelsesvej, ansøger/indehaver af markedsføringstilladelse i Medlemsstaterne
List of the names, pharmaceutical form, strength of the medicinal product, route of administration, applicant / marketing authorisation holder in the Member States
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.
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.
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.
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.
Under den decentrale procedure påpegede to berørte medlemsstater (Nederlandene og Frankrig) potentielle alvorlige risici vedrørende miljørisikovurderingen.
Potential serious risks were identified during the decentralised procedure by two concerned Member States regarding the environmental risk assessment (the Netherlands and France).
Prontax, pour-on opløsning, 5 mg/ml, til kvæg (og relaterede navne) indeholder doramectin.
Prontax 5 mg/ml pour-on solution for cattle (and associated names) contains doramectin.
På grundlag af de foreliggende data anså CVMP benefit/risk-forholdet for at være positivt for Prontax, pour-on opløsning, 5 mg/ml, forudsat at der i produktoplysningerne tilføjes de anbefalede foranstalt
Based on evaluation of the currently available data, the CVMP considered that the benefit-risk profile of Prontax 5 mg/ml pour-on solution for cattle and associated names is deemed to be positive provided that the recommended risk mitigation measures are added to the product information regarding risk to aquatic organisms and dung fauna.
1, for Prontax, pour-on opløsning til kvæg, 5 mg/ml, og relaterede navne
referral for Prontax 5 mg/ml pour-on solution for cattle and associated names
Udtalelse efter en indbringelse i henhold til artikel 33, stk. 4F F, for Prontax, pour-on opløsning til kvæg, 5 mg/ml, og relaterede navne EMA/421633/2012
Opinion following an Article 33(4)F F referral for Prontax 5 mg/ml pour-on solution for cattle and associated names
Den 8. februar 2012 vedtog CVMP derfor en positiv udtalelse og anbefalede udstedelse af markedsføringstilladelse for Prontax, pour-on opløsning, 5 mg/ml, til kvæg, og relaterede navne.
recommending the granting of a Marketing Authorisation for Prontax 5 mg/ml pour-on solution for cattle and associated names.