FrancophonIA/ELRC3.0 huggingface dataset:
English: CEPROTIN is a powder and solvent, which are mixed together to form a solution for injection.
Danish: CEPROTIN er pulver og solvens, der blandes til en opløsning til injektion.
English: CEPROTINCEPROTINOther information about CEPROTIN:
Danish: Andre oplysninger om CEPROTIN:
English: The results in the treatment of other types of clotting disorders, and of patients with other protein C deficiencies, were not sufficient to assess completely the use of CEPROTIN in these groups.
Danish: Resultaterne ved behandling af andre typer koagulationsforstyrrelser og af patienter med andre former for protein C-mangel var ikke tilstrækkelige til at foretage en fuldstændig vurdering af anvendelsen af CEPROTIN hos disse grupper.
English: CEPROTIN treatment should only be started by a doctor who has experience in this type of therapy and where it is possible to measure protein C activity.
Danish: Behandling med CEPROTIN bør kun igangsættes af en læge med erfaring i denne type behandling, og kun når der er mulighed for måling af protein C-aktiviteten.
English: When patients start receiving other anticoagulant medicines, such as warfarin, special care is needed and CEPROTIN treatment must be continued until the warfarin treatment is adjusted.
Danish: Når en patient påbegynder behandling med anden antikoagulerende medicin som warfarin, skal der udvises særlig forsigtighed, og behandlingen med CEPROTIN skal fortsætte, indtil warfarinbehandlingen er blevet justeret.
English: What is the risk associated with CEPROTIN?
Danish: Hvilken risiko er der forbundet med CEPROTIN?
English: Protein C slows down the production of thrombin, and therefore slows down further clotting.
Danish: Protein C nedsætter produktionen af trombin og hæmmer derfor yderligere koagulation af blodet.
English: The Committee for Medicinal products for Human Use (CHMP) decided that CEPROTIN's benefits are greater than its risks for patients with severe congenital protein C deficiency.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) fandt, at de gavnlige virkninger af Ceprotin er større end risiciene for patienter med medfødt svær protein C-mangel.
English: CEPROTIN has been studied in a total of 79 patients, 22 of whom had a diagnosis of the more severe forms of congenital protein C deficiency.
Danish: CEPROTIN er blevet undersøgt hos i alt 79 patienter, af hvilke 22 havde fået diagnosticeret medfødt protein C-mangel af sværere grad.
English: Why has CEPROTIN been approved?
Danish: Hvorfor blev CEPROTIN godkendt?
English: The main measures of the study were normalisation of protein C levels and other indicators of coagulation (clotting) activation.
Danish: Hovedmålene for forsøget var normalisering af protein C-niveauet og af andre tegn på aktivering af blodets koagulation.
English: An injection of CEPROTIN gives an immediate but temporary increase in levels of protein C. Replacement of protein C in protein C deficient patients should control or prevent thrombotic (clotting) problems in these patients.
Danish: En indsprøjtning af CEPROTIN bevirker en øjeblikkelig, men midlertidig stigning i indholdet af protein C. Erstatning af protein C hos patienter med protein C-mangel skulle kunne begrænse eller forhindre problemer med koagulation af blodet.
English: CEPROTIN contains human protein C, extracted and purified from human plasma (the liquid part of the blood).
Danish: CEPROTIN indeholder ekstraheret og renset humant protein C fra humant plasma (blodets væskeformige del).
English: CEPROTIN should not be used in people who may be hypersensitive (allergic) to human protein C, mouse protein or to heparin, except in life-threatening complications.
Danish: CEPROTIN bør ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for humant protein C, museprotein eller heparin, medmindre der er livstruende komplikationer.
English: CEPROTIN is used in patients with severe congenital (hereditary) protein C deficiency to treat purpura fulminans (extensive clotting of blood within the blood vessels, which causes the death of the tissues just beneath the skin, often leading to organ failure and amputations) and coumarin-induced skin necrosis (a complication of anticoagulant treatment with medicines such as warfarin, causing skin death).
Danish: CEPROTIN anvendes hos patienter med svær nedarvet protein C-mangel, dels til behandling af purpura fulminans (udbredt koagulation af blodet i blodkarrene, der medfører, at vævet lige under huden dør, ofte med organsvigt og amputationer til følge), dels til behandling af hudnekrose fremkaldt af kumarin (en komplikation, der kan optræde ved behandling med antikoagulerende stoffer som warfarin, og som medfører, at huden dør).
English: In patients with severe congenital protein C deficiency, CEPROTIN improved all 16 cases of purpura fulminans and all six episodes of coumarin-induced skin necrosis.
Danish: Hos patienter med medfødt svær protein C-mangel bevirkede CEPROTIN bedring i alle 16 tilfælde af purpura fulminans og i alle seks episoder af nekrose (henfald) af huden fremkaldt af kumarin.
English: In the body, protein C controls the generation of thrombin, one of the substances (factors) involved in blood clotting.
Danish: I kroppen kontrollerer protein C dannelsen af trombin, som hører til de stoffer (faktorer), der medvirker ved blodets koagulation.
English: It contains the active substance human protein C.
Danish: Det aktive stof i CEPROTIN er human protein C.
English: What is CEPROTIN?
Danish: Hvad er CEPROTIN?
English: Protein C is a natural substance in the blood that controls clotting.
Danish: Protein C er et stof, der findes naturligt i blodet og kontrollerer blodets koagulation (størkning).
English: How has CEPROTIN been studied?
Danish: Hvordan blev CEPROTIN undersøgt?
English: What is CEPROTIN used for?
Danish: Hvad anvendes CEPROTIN til?
English: What benefit has CEPROTIN shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved CEPROTIN?
English: CEPROTIN is also used for the short-term prevention of clotting in patients with severe congenital protein C deficiency in certain situations when there is an increased risk of clotting, such as surgery or when treatment with a coumarin is not sufficient or possible.
Danish: CEPROTIN anvendes desuden til kortsigtet forebyggelse af koagulation hos patienter med svær nedarvet protein C-mangel i visse situationer, hvor der er forhøjet risiko for koagulation.
English: If CEPROTIN is used in patients with severe congenital protein C deficiency, antibodies inhibiting protein C may develop.
Danish: Hvis CEPROTIN anvendes hos patienter med medfødt svær protein C-mangel, kan der udvikles antistoffer, der hæmmer virkningen af protein C. En fuldstændig liste over de indberettede bivirkninger ved CEPROTIN fremgår af indlægssedlen.
English: How does CEPROTIN work?
Danish: Hvordan virker CEPROTIN?
English: How is CEPROTIN used?
Danish: Hvordan anvendes CEPROTIN?
English: Cutaneous use Tube (alu)
Danish: Kutan anvendelse Tube (alu)
English: as well as hybrids of both species (equivalent to 0.5 - 1.0 g birch bark), corresponding to 72-88 mg betulin.
Danish: eller hybrider heraf, cortex (birkebark) svarende til 0,5-1 g birkebark, svarende til 72-88 mg betulin.
English: Extraction solvent: n-Heptane
Danish: Ekstraktionsmiddel: n-heptan
English: 1g of gel contains: 100 mg extract (as dry extract) from birch bark from Betula pendula Roth, Betula pubescens Ehrh.
Danish: --1 1 g gel indeholder 100 mg ekstrakt (som tørekstrakt) af Betula pendula Roth., Betula pubescens Ehrh.
English: MA (EU) number (Invented) name
Danish: MF (EU)-nummer (Særnavn) Navn Styrke Lægemiddelform Administration Emballage Indhold (koncentration)
English: Further information on Esperoct can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/esperoct.
Danish: Yderligere information om Esperoct findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/esperoct.
English: Other information about Esperoct
Danish: Andre oplysninger om Esperoct
English: As for all medicines, data on the use of Esperoct are continuously monitored.
Danish: Som for alle lægemidler er data vedrørende brug af Esperoct løbende overvåget.
English: Hypersensitivity (allergic) reactions can occur with Esperoct and are uncommon (affecting up to 1 in 100 people).
Danish: Overfølsomhedsreaktioner (allergiske reaktioner) kan forekomme med Esperoct og er ikke almindelige (kan forekomme hos op til 1 ud af 100 personer).
English: Esperoct can be used in adults and children from 12 years of age.
Danish: Esperoct kan anvendes til voksne og børn over 12 år.
English: Patients or their carers may be able to inject Esperoct themselves at home once they have been trained appropriately.
Danish: Patienten eller dennes omsorgsperson kan selv injicere Esperoct derhjemme efter at have fået passende oplæring.
English: When bleeding episodes occurred, they were successfully treated with one or two further injections in 94% of cases.
Danish: Når blødningsepisoderne opstod, kunne de behandles med et eller to yderligere indsprøjtninger i 94 % af tilfældene.
English: What measures are being taken to ensure the safe and effective use of Esperoct?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Esperoct?
English: For more information about using Esperoct, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Esperoct, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Since this could potentially cause problems especially in children below 12 years of age, Esperoct is only approved for use in adults and children from 12 years of age.
Danish: Da dette potentielt kan medføre problemer, især hos børn under 12 år, er Esperoct kun godkendt til voksne og børn i alderen 12 år og derover.
English: The European Medicines Agency decided that Esperoct's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Esperoct opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Side effects reported with Esperoct are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Esperoct vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Very rarely, patients may develop antibodies against hamster protein in the medicine and have allergic reactions.
Danish: Meget sjældent kan patienter udvikle antistoffer mod hamsterprotein i lægemidlet og få allergiske reaktioner.
English: The dose, frequency and duration of treatment depend on whether it is used to treat or prevent bleeding, as well as on the severity of the haemophilia, the extent and location of the bleeding and the patient's condition and weight.
Danish: Dosis, hyppighed og behandlingsvarighed afhænger af, om det skal anvendes til behandling eller til forebyggelse af blødning, sygdommens sværhedsgrad, blødningsomfang og sted samt patientens tilstand og vægt.
English: An overview of Esperoct and why it is authorised in the EU
Danish: En oversigt over Esperoct og hvorfor det er godkendt i EU
English: What is Esperoct and what is it used for?
Danish: Hvad er Esperoct, og hvad anvendes det til?
English: These include swelling, burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, low blood pressure, lethargy, nausea and vomiting, restlessness, a rapid heartbeat, tightness of the chest, tingling and wheezing.
Danish: Disse omfatter hævelse, brændende og stikkende fornemmelse på injektionsstedet, kulderystelser, rødme af huden, kløende udslæt, hovedpine, nældefeber, lavt blodtryk, sløvhed, kvalme og opkastning, rastløshed, hurtig hjerterytme, trykken for brystet, stikkende fornemmelse og hvæsende vejrtrækning.
English: Why is Esperoct authorised in the EU?
Danish: Hvorfor blev Esperoct godkendt i EU?
English: In such cases, a specialised haemophilia centre should be contacted.
Danish: I disse tilfælde bør man kontakte en specialafdeling for hæmofili.
English: The company that markets Esperoct will carry out a study to investigate the potential effects of PEG accumulation in the choroid plexus of the brain and other tissues and organs.
Danish: Virksomheden, der markedsfører Esperoct, skal gennemføre et studie af de mulige virkninger af PEGophobning i hjernens plexus choroideus og andre væv og organer.
English: Esperoct is given as an injection into a vein.
Danish: Esperoct gives ved indsprøjtning i en vene.
English: In a study involving patients between 12 and 66 years of age, 175 patients given Esperoct every 4 days or twice weekly as preventive treatment had, on average, around 4 bleeding episodes a year, achieving the target of the study, which was less than 8.5 episodes a year.
Danish: I et studie, der omfattede patienter mellem 12 og 66 år, havde 175 patienter, der fik Esperoct hver 4. dag eller to gange om ugen som forebyggende behandling, gennemsnitligt ca. 4 blødningsepisoder om året, og nåede dermed studiets mål, som var under 8,5 episoder om året.
English: These patients had on average around 32 bleeding episodes a year and Esperoct was successful at stopping the bleeds 97% of the time after 1 or 2 injections.
Danish: Disse patienter havde i gennemsnit ca. 32 blødningsepisoder om året, og med Esperoct lykkedes det at standse deres blødninger i 97 % af tilfældene efter 1 eller 2 indsprøjtninger.
English: Twelve further patients in this study did not receive preventive treatment but were given Esperoct for treating bleeding ‘on demand'.
Danish: Yderligere tolv patienter i dette studie fik ikke forebyggende behandling, men fik Esperoct til at behandle de blødninger, der opstod.
English: Studies have found that Esperoct is effective at preventing and treating bleeding in patients with haemophilia A. Because Esperoct is ‘pegylated', patients on this medicine could also have fewer or less frequent injections than they would on conventional FVIII products.
Danish: Studier har vist, at Esperoct er effektivt til at forebygge og behandle blødning hos patienter med hæmofili A. Eftersom Esperoct er "pegyleret", kan patienter, der får dette lægemiddel, også nøjes med færre eller mindre hyppige indsprøjtninger, end de ville få med konventionelle faktor VIII-produkter.
English: Part of the active substance is a chemical called polyethylene glycol (PEG), which is added to help the medicine remain in the body for longer and thereby prolong its action.
Danish: En del af det aktive stof er et kemisk stof kaldet polyethylenglycol (PEG), der er tilføjet, så lægemidlet bliver længere i kroppen og dermed virker længere.
English: What are the risks associated with Esperoct?
Danish: Hvilke risici er der forbundet med Esperoct?
English: Esperoct can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of haemophilia.
Danish: Esperoct udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af hæmofili.
English: The active substance in Esperoct, turoctocog alfa pegol, works in the body in the same way as human factor VIII.
Danish: Det aktive stof i Esperoct, turoctocog alfa pegol, virker på samme måde i kroppen som kroppens egen faktor VIII.
English: For the full list of side effects and restrictions with Esperoct, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Esperoct fremgår af indlægssedlen.
English: It replaces the missing factor VIII, thereby helping the blood to clot and giving temporary control of the bleeding disorder.
Danish: Det erstatter den manglende faktor VIII og får derfor blodet til at størkne, så der opnås midlertidig kontrol med blødningsforstyrrelsen.
English: In a second study in 68 children aged below 12 years, Esperoct given as preventive treatment reduced the number of bleeding episodes to around 2 episodes a year.
Danish: I et andet studie med 68 børn under 12 år reducerede Esperoct som forebyggende behandling antallet af blødningsepisoder til ca. 2 episoder om året.
English: Following treatment with factor VIII products, including Esperoct, some patients may develop inhibitors (antibodies) against factor VIII, causing the medicine to stop working and resulting in a loss of bleeding control.
Danish: Efter behandling med faktor VIII-lægemidler, herunder Esperoct, kan nogle patienter danne antistoffer mod faktor VIII, hvilket medfører, at lægemidlet ikke længere virker, og at kontrollen med blødning svigter.
English: Esperoct must not be used in patients with allergy to hamster proteins.
Danish: Esperoct må ikke gives til patienter, som er allergiske over for hamsterproteiner.
English: Esperoct contains the active substance turoctocog alfa pegol.
Danish: Esperoct indeholder det aktive stof turoctocog alfa pegol.
English: Esperoct has been shown to be effective at preventing and treating bleeding episodes in patients with severe haemophilia who were previously treated with other factor VIII products.
Danish: Det påvist, at Esperoct forebygger og behandler blødningsepisoder hos patienter med svær hæmofili, som tidligere blev behandlet med andre faktor VIII-produkter.
English: Esperoct is a medicine used to treat and prevent bleeding in patients with haemophilia A, an inherited bleeding disorder caused by the lack of a clotting protein known as factor VIII.
Danish: Esperoct er et lægemiddel til behandling og forebyggelse af blødning hos patienter med den arvelige blødningsforstyrrelse hæmofili A, der skyldes mangel på blodstørkningsproteinet faktor VIII.
English: How is Esperoct used?
Danish: Hvordan anvendes Esperoct?
English: What benefits of Esperoct have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Esperoct?
English: Patients with haemophilia A lack factor VIII, a protein needed for normal clotting of the blood, and as a result, they bleed readily.
Danish: Patienter med hæmofili A mangler faktor VIII, der er et protein, som er nødvendigt for, at blodet kan størkne normalt, og de har derfor en øget tendens til blødning.
English: How does Esperoct work?
Danish: Hvordan virker Esperoct?
English: However, part of the active substance in Esperoct (called PEG) may accumulate in the body, including in a structure in the brain called the choroid plexus, following long-term treatment.
Danish: Efter langvarig behandling kan en del af det aktive stof i Esperoct (det såkaldte PEG) imidlertid ophobes i kroppen, herunder i årenettet (plexus choroideus) i hjernen.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Esperoct have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Esperoct.
English: Continue your morning activities.
Danish: Fortsæt med dine morgenaktiviteter.
English: • you have cancer,
Danish: • Du har kræft,
English: Date of first authorisation: 16 October 2009 Date of latest renewal: 18 September 2014
Danish: Dato for første markedsføringstilladelse: 16. oktober 2009 Dato for seneste fornyelse: 18. september 2014
English: • you are or have been a smoker (as this may increase the risk of dental problems).
Danish: • Du er eller har været ryger (da det kan øge risikoen for tandproblemer).
English: Follow these instructions carefully.
Danish: Følg disse instruktioner nøje.
English: • Risk Management Plan (RMP)
Danish: • Risikostyringsprogram (RMP)
English: Total body BMD also increased significantly.
Danish: Total BMD øgedes også signifikant.
English: Do not take two tablets on the same day.
Danish: Tag ikke to tabletter på samme dag.
English: Protein binding in human plasma is approximately 78 %.
Danish: Proteinbindingen i humant plasma er ca. 78 %.
English: You can sit, stand or walk - just stay fully upright.
Danish: Du kan sidde, stå eller gå - blot du forbliver oprejst.
English: Like muscles, bones need exercise to stay strong and healthy.
Danish: Ligesom musklerne har knoglerne brug for motion for at forblive stærke og sunde.
English: Further hydroxylation occurs prior to elimination.
Danish: Yderligere hydroxylering forekommer før elimination.
English: (malabsorption syndrome),
Danish: (malabsorptionssyndrom),
English: This adverse reaction was identified through post-marketing surveillance.
Danish: Denne bivirkning blev identificeret via post-marketing overvågning.
English: The time to onset of symptoms varied from one day to several months after starting treatment.
Danish: Tiden til symptomdebut varierede fra én dag til adskillige måneder efter behandlingsstart.
English: • rash made worse by sunlight,
Danish: • Udslæt forværret af sollys.
English: Therefore, it is important that you follow the advice given in section 3.
Danish: Det er derfor vigtigt, at du følger instruktionen i punkt 3.
English: To permit adequate absorption of alendronate:
Danish: For at sikre tilstrækkelig absorption af alendronat:
English: Please read it carefully.
Danish: Læs denne omhyggeligt.
English: Plasma concentrations fell by more than 95 % within six hours following intravenous administration.
Danish: Plasmakoncentrationen falder med mere end 95 % inden for 6 timer efter intravenøs administration.
English: Supplemental vitamin D reduces these risks and their consequences.
Danish: D-vitamintilskud reducerer disse risici og deres konsekvenser.
English: Do not make yourself vomit, and do not lie down.
Danish: Fremkald ikke opkastning og læg dig ikke ned.
English: If you experience any of these side effects you should not drive until you feel better.
Danish: Hvis du får nogle af disse bivirkninger, må du ikke køre bil, før du får det bedre.
English: While on treatment, these patients should avoid invasive dental procedures if possible.
Danish: Mens de er i behandling, bør disse patienter om muligt undgå invasive dentale indgreb.
English: - It is particularly important to understand the information in section 3 before taking this medicine.
Danish: - Det er især vigtigt, at du forstår oplysningerne i punkt 3, før du tager dette lægemiddel.
English: The frequency of rare was estimated based on relevant clinical trials.
Danish: Hyppigheden sjælden blev estimeret ud fra relevante kliniske forsøg.
English: The two treatment groups were also similar with regard to BMD increases at other skeletal sites.
Danish: De to behandlingsgrupper var også ens med hensyn til stigninger i BMD andre steder.
English: As well as your treatment with VANTAVO, your doctor may suggest you make changes to your lifestyle to help your condition, such as:
Danish: Såvel som behandling med VANTAVO kan din læge foreslå, at du foretager nogle ændringer i din livsstil, som kan hjælpe dig i din tilstand, for eksempel:
English: What is vitamin D?
Danish: Hvad er D-vitamin?
English: Since it is not known how long you should take VANTAVO, you should discuss the need to stay on this medicine with your doctor periodically to determine if VANTAVO is still right for you.
Danish: Da det er ukendt, hvor lang tid du skal tage VANTAVO, skal du med jævne mellemrum diskutere behovet for at fortsætte med dette lægemiddel med din læge for at afgøre, om VANTAVO stadig er rigtigt for dig.
English: Children and adolescents VANTAVO should not be given to children and adolescents less than 18 years of age.
Danish: Børn og unge VANTAVO bør ikke gives til børn og unge under 18 år.
English: Frequencies are defined as: very common (≥1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000)
Danish: Frekvenserne er defineret således: Meget almindelig (≥1/10), almindelig (1/100 til <1/10), ikke almindelig (1/1.000 til <1/100), sjælden (1/10.000 til <1/1.000), meget sjælden (<1/10.000).
English: VANTAVO is effective only if taken when your stomach is empty.
Danish: VANTAVO er kun effektivt, hvis det tages på tom mave.