FrancophonIA/ELRC3.0 huggingface dataset:
English: Furthermore, during the initiation of oral anticoagulant therapy it is advisable to start with a low dose and adjust this incrementally, rather than use a standard loading dose.
Danish: Endvidere tilrådes det under påbegyndelsen af oral antikoagulationsbehandling at begynde med en lav dosis og justere denne gradvist stigende frem for at anvende en standard 'loading' dosis.
English: If you have kidney and/or liver disease, please inform your doctor, because he may have to adjust your treatment accordingly.
Danish: Hvis De har nyre og/eller lever sygdom, oplys da venligst Deres læge om dette, fordi Deres behandling så måske skal justeres.
English: Difference between the recipient species and human Protein C will inevitably result in an immune response with antibody formation.
Danish: Forskellen mellem modtager arter og human protein C vil nødvendigvis resultere i en immun reaktion med antistof dannelse.
English: This transient effect may be explained by the fact that protein C, itself a vitamin K dependent plasma protein, has a shorter half-life than most of the vitamin K dependent proteins (i.e. II, IX and X).
Danish: Denne forbigående tilstand kan forklares ved det faktum, at protein C, som også er et vitamin K afhængigt plasmaprotein, har en kortere halveringstid end de fleste vitamin K afhængige proteiner (f.eks. II, IX og X).
English: 3 years The reconstituted solution should be used immediately.
Danish: 3 år Det opløste præparat skal anvendes omgående.
English: Take special care with CEPROTIN if symptoms of allergy occur.
Danish: Vær særlig forsigtig med at anvende CEPROTIN hvis allergiske symptomer opstår.
English: The dosage should be determined on the basis of laboratory measurements of the protein C activity.
Danish: Doseringen bør bestemmes på basis af laboratoriebestemmelser af protein C aktiviteten.
English: The preparation may contain traces of heparin and/or mouse protein as a result of the manufacturing process.
Danish: Produktet kan indeholde spormængder af heparin og/eller museprotein efter fremstillingsprocessen.
English: Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses.
Danish: Fremstillere af disse produkter inkluderer også trin i behandlingen af blod eller plasma, som kan inaktivere eller fjerne vira.
English: CEPROTIN proved to have no mutagenic potential in the Ames test performed.
Danish: CEPROTIN viste ikke-mutagenicitet i udført Ames test.
English: Patients treated during the acute phase of their disease may display much lower increases in protein C activity.
Danish: Patienter behandlet under den akutte fase af deres sygdom kan udvise meget lavere stigning i protein C aktivitet.
English: Single dose toxicity testing showed that even doses of several times the recommended human dosage per kilogram body weight (10-fold) did not result in toxic effects on rodents.
Danish: Endotoksicitetstest viste at selv doser, der var flere gange den dosis der anbefales mennesker pr. kg legemsvægt (10 gange), ikke førte til toksiske effekter hos gnavere.
English: CEPROTIN may contain trace amounts of heparin.
Danish: CEPROTIN kan indeholde spormængder af heparin.
English: Twelve courses of short-term prophylaxis prior to surgery or invasive therapy and 7 courses of long-term prophylaxis were included in the efficacy analyses.
Danish: Tolv forløb med korttids profylakse inden kirurgisk eller invasiv terapi og 7 forløb af langtids profylakse var indeholdt i effektanalyserne.
English: It is converted by thrombin/thrombomodulin-complex on the endothelial surface to activated protein C (APC).
Danish: Det er konverteret af thrombin/thrombomodulin-kompleks på den endotele overflade til aktiveret protein C (APC).
English: This also applies to unknown or emerging viruses and other pathogens.
Danish: Dette gælder også for hidtil ukendte eller nye vira og andre patogener.
English: The dose should be adjusted on the basis of laboratory assessment for each individual case.
Danish: Dosering bør justeres på basis af resultater af laboratorieprøver i det enkelte tilfælde.
English: White or cream coloured powder or friable solid.
Danish: Hvidt eller cremefarvet pulver eller sprødt fast stof.
English: - if you are allergic to Human Protein C or any of the other ingredients of this medicine (listed in section 6) including mouse protein or heparin.
Danish: - hvis De er allergisk over for human protein C eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6) inklusiv museprotein eller heparin.
English: This also applies to any unknown or emerging viruses or other types of infections.
Danish: Dette gælder også for hidtil ukendte eller nye vira eller andre typer af smitte.
English: The distribution of the related ADRs is as follows:
Danish: Fordelingen af de relaterede bivirkninger er følgende:
English: Gently rotate the vial until all powder is dissolved.
Danish: Rotér forsigtigt hætteglasset, indtil alt pulver er opløst.
English: However, in the case of life-threatening thrombotic complications your doctor may still decide to continue treatment with CEPROTIN.
Danish: Imidlertid kan Deres læge i tilfælde af livstruende trombotiske komplikationer alligevel beslutte at fortsætte behandling med CEPROTIN.
English: Dosages of the above studies, covering 83 patients, indicate that dosing guidelines for adult subjects are also valid for neonatal and paediatric patient population.
Danish: Doseringer i de nævnte studier omfattende 83 patienter indikerer, at dosisvejledninger for voksne personer også gælder for nyfødte og pædiatriske patienter.
English: If such symptoms occur during the administration of CEPROTIN, injection should be stopped.
Danish: Hvis sådanne reaktioner forekommer under indgivelsen af CEPROTIN bør injektionen stoppes.
English: Additionally, CEPROTIN may be used to treat a rare complication of a blood thinner medication (anticoagulant medication named coumarin) which may result in severe skin lesion (necrosis).
Danish: Derudover kan CEPROTIN måske anvendes til behandling af sjældne komplikationer fra en blodfortyndende medicin (antikoaguleringsmedicin kaldet coumarin), som måske kan resultere i alvorlig hud læsion (nekrose).
English: These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections.
Danish: Disse omfatter omhyggelig udvælgelse af blod og plasma donorer for at sikre de med risiko for at være bærere af smitte udelukkes, samt kontrol af hver donation og plasma pools for tegn på vira/smitte.
English: APC is a serine protease with potent anticoagulant effects, especially in the presence of its cofactor protein S. APC exerts its effect by the inactivation of the activated forms of factors V and VIII which leads to a decrease in thrombin formation.
Danish: APC er en serin protease med potent antikoagulationseffekt, specielt ved tilstedeværelse af dets cofaktor protein S. APC udøver sin virkning ved inaktivering af de aktiverede former af faktorer V og VIII, som fører til nedsættelse af thrombin dannelse.
English: In the case of an acute thrombotic event these should be performed every 6 hours until the patient is stabilised, thereafter twice a day and always immediately before the next injection.
Danish: I tilfælde af en akut trombotisk hændelse bør disse udføres hver 6. time, indtil patienten er stabiliseret, derefter to gange om dagen og altid straks før næste injektion.
English: The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
Danish: Forholdsreglerne kan være af begrænset værdi over for ikke-kapsel vira som parvovirus B19.
English: In patients with HIT, symptoms such as arterial and venous thrombosis, disseminated intravascular coagulation (DIC), purpura, petechiae and gastrointestinal bleeding (melena), may occur.
Danish: Hos patienter med HIT kan symptomer som arteriel eller venøs thrombose, dissemineret intravaskulær koagulation (DIC), purpura, petecchie og gastrointestinal blødning (melena) måske forekomme.
English: In case of acute thrombosis CEPROTIN may be administered to you every 6 hours.
Danish: I tilfælde af akut trombose kan CEPROTIN indgives hver 6. time.
English: Skin and subcutaneous tissue disorders hyperhydrosis
Danish: Hud og subkutane væv hyperhidrose
English: An initial dose of 60 to 80 IU/kg should be administered.
Danish: En initial dosis på 60 til 80 IE/kg bør indgives.
English: Such symptoms may constitute an allergic reaction to any of the components, to mouse protein or heparin.
Danish: Sådanne symptomer kan udgøre en allergisk reaktion over for et af indholdsstofferne, museprotein eller heparin.
English: When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients.
Danish: Når lægemidler er fremstillet af humant blod eller plasma, er der indført bestemte forholdsregler for at undgå smitte overføres til patienter.
English: In the case of an acute thrombotic event these should be performed every 6 hours until your condition is stabilised, thereafter twice a day and always immediately before the next injection.
Danish: I tilfælde af en akut trombotisk hændelse bør disse udføres hver 6. time, indtil Deres forhold er stabiliseret, derefter to gange om dagen og altid straks før næste injektion.
English: Frequency Category by infusions
Danish: Hyppigheds kategori efter infusion
English: Concurrent anticoagulant medication (such as heparin) may have been responsible for these bleeding episodes.
Danish: Samtidig antikoagulations medicinering (som heparin) kan have været ansvarlig for disse blødningsepisoder.
English: Powder: - The active substance is human protein C - The other ingredients are human albumin, sodium chloride and sodium citrate.2H2O.
Danish: Pulver: - Det aktive stof er human protein C - De øvrige indholdsstoffer er humant albumin, natriumchlorid og natriumcitratdihydrat.
English: The study is a randomized, double-blind, placebo-controlled dose-finding study, in the indication of acquired protein C deficiency due to meningococcal sepsis (IMAG 112).
Danish: Studiet er et randomiseret, dobbelt blindt, placebokontrolleret dosis-resultat studie og det er til indikation af erhvervet protein C mangel, som skyldes meningokok sepsis (IMAG 112).
English: All unused solution, empty vials and used needles and syringes must be discarded appropriately.
Danish: Alle rester af opløsningen, tomme hætteglas og brugte kanyler samt sprøjter skal bortskaffes på passende vis.
English: An initial dose of 60 to 80 IU/kg for determination of recovery and half-life is advised.
Danish: En initial dosis på 60 til 80 IE/kg til bestemmelse af genfinding og halveringstid anbefales.
English: Important information about some of the ingredients of CEPROTIN
Danish: Vigtige oplysninger om nogle af indholdsstofferne i CEPROTIN:
English: Appropriate vaccination (hepatitis A and B) should be considered for patients in regular / repeated receipt of human plasma-derived Protein C products.
Danish: Passende vaccination (hepatitis A og B) bør overvejes for patienter i regelmæssig / gentagen behandling med humane plasmaudvundne Protein C produkter.
English: Identifying HIT is complicated by the fact that these symptoms may already be present in acute phase patients with severe congenital protein C deficiency.
Danish: Identifikation af HIT er kompliceret ved det faktum, at disse symptomer allerede kan være til stede i den akutte fase hos patienter med alvorlig medfødt protein C mangel.
English: • In the postmarketing experience there have been reports of restlessness, excessive sweating, and pain and redness at the injection site.
Danish: • Fra erfaring efter markedsføring af produktet har der været rapporter om rastløshed, forøget sveddannelse samt smerte og rødme på injektionsstedet.
English: In patients starting treatment with oral anticoagulants belonging to the class of vitamin K antagonists (e.g. warfarin), a transient hypercoagulable state may arise before the desired anticoagulant effect becomes apparent.
Danish: Hos patienter, der påbegynder behandling med orale antikoagulanter hørende til gruppen af vitamin K antagonister (f.eks. warfarin), kan der forekomme en forbigående hyperkoagulationstilstand, inden den ønskede antikoagulationseffekt indtræffer.
English: During clinical studies with CEPROTIN, a total of 3 non-serious adverse drug reactions (ADRs) were reported in 1 of 67 patients enrolled (rash and pruritus (grouped as hypersensitivity), and dizziness).
Danish: Under kliniske studier med CEPROTIN blev der rapporteret i alt 3 ikke-alvorlige bivirkninger (ADR'er) hos 1 ud af 67 inkluderede patienter (udslæt og pruritus (grupperet som overfølsomhed) og svimmelhed).
English: The solvent comes in vials of neutral glass of hydrolytic type I. The product and the solvent vials are closed with butyl rubber stoppers.
Danish: Solvenset leveres i hætteglas af neutralt glas af hydrolytisk type I. Produkt og solvens hætteglassene er lukket med butyl gummipropper.
English: The potency (IU) is determined using a chromogenic substrate method against the World Health Organisation (WHO) International standard.
Danish: Styrken (IE) fastsættes ved en kromogen substrat metode over for WHO's internationale standard.
English: In children with a body weight of less than 10 kg, the injection rate should not exceed a rate of 0.2 ml/kg/min.
Danish: Hos børn med en legemsvægt på mindre end 10 kg bør injektionshastigheden ikke overstige 0,2 ml/kg/min.
English: If you change to treatment with oral anticoagulants, treatment with CEPROTIN must continue until the blood level of the oral anticoagulation is adequate and stable.
Danish: Hvis De ændrer til at blive behandlet med orale antikoagulanter, skal behandlingen med CEPROTIN fortsættes, indtil niveauet af den orale antikoagulation i blodet er passende og stabil.
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection, and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Danish: Standard forholdsregler for at undgå smitte som følge af anvendelsen af lægemidler fremstillet af humant blod eller plasma omfatter udvælgelse af donorer, screening af enkeltdonationer og plasma pools for specifikke smittemarkører og inkludering af effektive fremstillingstrin for inaktivering/fjernelse af vira.
English: CEPROTIN belongs to a class of medicines called antithrombotics.
Danish: CEPROTIN hører til typen af medicin kaldet antitrombotisk medicin.
English: Other experience with CEPROTIN covers case reports and a clinical study in overall 69 paediatric patients with acquired protein C deficiency.
Danish: Anden erfaring med CEPROTIN omfatter sygejournaler og et klinisk studie, i alt 69 pædiatriske patienter, med erhvervet protein C mangel.
English: Although CEPROTIN has been used safely in the treatment of pregnant protein C-deficient women, its safety for use in human pregnancy has not been established in controlled clinical trials.
Danish: Selvom CEPROTIN har været anvendt sikkert i behandling af gravide kvinder med protein C mangel, er sikkerheden ved brug i forbindelse med graviditet hos mennesker endnu ikke påvist i kontrollerede, kliniske forsøg.
English: Indication was prevention and treatment of purpura fulminans and thrombotic disease, enrolling overall 14 subjects of 2 days old throughout adolescence.
Danish: Indikation var forebyggelse og behandling af purpura fulminans og trombotisk sygdom, og der var i alt 14 forsøgspersoner i en alder fra 2 dage til unge.
English: Protein C contained in CEPROTIN is a normal constituent of human plasma and acts like endogenous protein C. Therefore experimental studies on tumorigenic or mutagenic effects - particularly in heterologous species - are not considered necessary.
Danish: Protein C, som er indeholdt i CEPROTIN, findes naturligt i humant plasma og virker som endogent protein C. Derfor anses eksperimentelle studier af tumorfremkaldende eller mutagene effekter - særligt hos heterologe arter - ikke for at være nødvendige.
English: The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A virus.
Danish: Forholdsreglerne anses for at være effektive for kapsel vira som human immundefekt virus (HIV), hepatitis B virus og hepatitis C virus samt for ikke-kapsel hepatitis A virus.
English: General disorders and administration site conditions injection site reaction
Danish: Almene symptomer og reaktioner på administrationsstedet reaktion på injektionsstedet
English: For the events that allergic symptoms arise which are of an acute and life-threatening nature, administration should be made within reach of life-supporting facilities.
Danish: I det tilfælde, at der opstår allergiske symptomer, som er af akut og livstruende natur, bør indgivelsen udføres med livsopretholdende udstyr inden for rækkevidde.
English: In rare and exceptional cases, subcutaneous infusion of 250-350 IU/kg was able to produce therapeutic protein C plasma levels in patients with no intravenous access.
Danish: I sjældne og usædvanlige tilfælde var det muligt at frembringe terapeutiske protein C plasmaniveauer ved subkutan infusion af 250-350 IE/kg hos patienter, som ikke havde intravenøs adgang.
English: • The following side effects were rarely observed during clinical studies (less than 1 case in 1000 administrations given to patients): itching (pruritus), rash and dizziness.
Danish: • Under kliniske forsøg blev følgende bivirkninger observeret i sjælden grad (dvs. i mindre end 1 tilfælde ud af 1.000 indgivelser til patienter): kløe (pruritus), udslæt og svimmelhed.
English: No formal clinical study in either paediatric or neonatal population with severe congenital protein C deficiency was ever conducted.
Danish: Der har aldrig været udført noget formelt klinisk studie hos hverken pædiatriske eller nyfødte patienter med alvorlig medfødt protein C mangel.
English: 21 asymptomatic subjects with homozygous or double heterozygous protein C deficiency were evaluated for pharmacokinetic data.
Danish: 21 asymptomatiske forsøgspersoner med homozygot eller dobbelt heterozygot protein C mangel blev evalueret for farmakokinetiske data.
English: The solution should be discarded if particulate matter is visible.
Danish: Opløsningen skal kasseres, hvis den indeholder synlige partikler.
English: Protein C plays a major role in prevention of excessive clot formation thus, prevent and/or treat intravascular thrombosis.
Danish: Protein C spiller en hovedrolle i forebyggelse af for megen størkningsdannelse og dermed forebyggelse og/eller behandling af intravaskulær trombose.
English: CEPROTIN is intended for intravenous administration (infusion into a vein).
Danish: CEPROTIN er beregnet til intravenøs indgivelse (infusion ind i en vene).
English: Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly/repeatedly receive human plasma-derived Protein C products.
Danish: Deres læge vil anbefale, at De overvejer vaccination mod hepatitis A og B, hvis De er i regelmæssig / gentagen behandling med humane plasmaudvundne Protein C produkter.
English: * One International Unit (IU) of protein C corresponds to the amidolytically measured activity of protein C in 1 ml of normal plasma.
Danish: * 1 International Enhed (IE) af protein C svarer til den amidolytisk bestemte aktivitet af protein C i 1 ml normal plasma.
English: This medicine contains Protein C, a natural protein that is made in the liver and is present in your blood.
Danish: Denne medicin indeholder Protein C, et naturligt protein, som er dannet i leveren og findes i Deres blod.
English: You may notice any of the following side effects after administration of CEPROTIN:
Danish: De kan måske få nogen af følgende bivirkninger efter indgivelse af CEPROTIN:
English: CEPROTIN has no influence on your ability to drive or to operate machines.
Danish: CEPROTIN har ingen indflydelse på Deres evne til at køre bil eller betjene maskiner.
English: • when coumarin therapy alone is not sufficient
Danish: • når coumarin terapi alene ikke er tilstrækkelig
English: CEPROTIN should be administered at a maximum injection rate of 2 ml per minute.
Danish: CEPROTIN bør indgives ved en injektionshastighed på højst 2 ml pr. minut.
English: • while initiating coumarin therapy
Danish: • under påbegyndelse af coumarin terapi
English: After reconstitution the solution is colourless to slightly yellowish and clear to slightly opalescent and essentially free from visible particles.
Danish: Efter opløsning er opløsningen farveløs til let gullig og klar til let opaliserende og væsentlig fri for synlige partikler.
English: It is strongly recommended that every time that CEPROTIN is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Danish: Det anbefales kraftigt at notere navn og batch nummer på produktet hver gang CEPROTIN indgives til en patient for at bevare en forbindelse mellem patienten og batchen af produktet.
English: It should be kept in mind that the half-life of protein C may be severely shortened in certain clinical conditions such as acute thrombosis with purpura fulminans and skin necrosis.
Danish: Man bør huske på, at halveringstiden for protein C kan være alvorligt forkortet under visse kliniske forhold som akut trombose med purpura fulminans og hudnekroser.
English: In patients with acute thrombotic disease, both the incremental increase in protein C plasma levels as well as half-life may be considerably reduced.
Danish: Hos patienter med akut thrombotisk sygdom kan både den gradvist voksende stigning i protein C plasma niveauer såvel som halveringstiden reduceres betragteligt.
English: Patients with renal and/or hepatic impairment should be monitored more closely.
Danish: Patienter med nyre og/eller lever svækkelse bør overvåges mere nøje (se pkt.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: De kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmesidehttp://www.ema.europa.eu.
English: 1221 Vienna
Danish: 1221 Wien
English: Other medicines and CEPROTIN
Danish: Brug af anden medicin sammen med CEPROTIN
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) AF DET (DE) BIOLOGISK AKTIVE STOF(FER) OG FREMSTILLER(E) ANSVARLIGE FOR BATCHFRIGIVELSE
English: A separate unused filter needle must be used to withdraw each vial of reconstituted CEPROTIN.
Danish: En separat uanvendt filterkanyle skal anvendes til at overføre hvert hætteglas opløst CEPROTIN.
English: Treatment with CEPROTIN should be initiated under the supervision of a physician experienced in substitution therapy with coagulation factors/inhibitors where monitoring of protein C activity is feasible.
Danish: Behandling med CEPROTIN bør påbegyndes under overvågning af en læge med erfaring i substitutionsterapi med koagulationsfaktorer/inhibitorer, hvor overvågning af protein C aktivitet er mulig.
English: • while initiating coumarin (anticoagulant medication, blood thinner) therapy
Danish: • under påbegyndelse af coumarin behandling (antikoaguleringsmedicin, blodfortyndende)
English: CEPROTIN is presented as powder and solvent for solution for injection and is a white or cream coloured powder or friable solid.
Danish: CEPROTIN leveres som pulver og solvens til injektionsvæske, opløsning og er et hvidt eller cremefarvet pulver eller sprødt stof.
English: The reconstituted solution should be used immediately.
Danish: Tilberedt opløsning bør anvendes omgående.