FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are switched to permanent prophylaxis with oral anticoagulants, protein C replacement is to be discontinued only when stable anticoagulation is obtained (see “Important information about some of the ingredients of CEPROTIN”).
Danish: Hvis De er skiftet til permanent profylaktisk behandling med orale antikoagulanter, skal protein C erstatningen kun afbrydes, når stabil antikoagulation er opnået (se ”Vigtige oplysninger om nogle af indholdsstofferne i CEPROTIN”).
English: Protein C is a vitamin K-dependent anticoagulant glycoprotein which is synthesised in the liver.
Danish: Protein C er et vitamin K afhængigt antikoagulations glycoprotein, som syntetiseres i leveren.
English: It is strongly recommended that every time you receive a dose of CEPROTIN the name and batch number of the product are recorded in order to maintain a record of the batches used.
Danish: Det anbefales kraftigt at notere navn og batch nummer på produktet hver gang De får en dosis af CEPROTIN for at bevare en fortegnelse over de anvendte batcher.
English: As the quantity of sodium in the maximum daily dose may exceed 200 mg, this should be taken into consideration by patients on a controlled sodium diet.
Danish: Da mængden af natrium i den maksimale daglige dosis kan overstige 200 mg, kan det være skadeligt for personer på en lav natriumdiæt.
English: The dose, administration frequency and duration of treatment depend on the severity of the protein C deficiency as well as on your clinical condition and on your plasma level of protein C. They should be adjusted accordingly on the basis of clinical effectiveness and laboratory assessment.
Danish: Dosering, hyppighed for indgivelse og varighed af behandlingen afhænger både af, hvor alvorlig protein C manglen er, og af Deres kliniske tilstand samt Deres plasmaniveau af protein C. De bør justeres på basis af den kliniske effekt og resultater af laboratorieprøver i det enkelte tilfælde.
English: In patients with combined severe congenital protein C deficiency and with APC resistance, there are limited clinical data to support the safety and efficacy of CEPROTIN.
Danish: Hos patienter med kombineret alvorlig medfødt protein C mangel og med APC resistens findes der begrænsede kliniske data til underbygning af CEPROTIN's sikkerhed og effekt.
English: What you need to know before you use CEPROTIN
Danish: Det skal De vide, før De begynder at bruge CEPROTIN
English: The reconstituted solution should be administered immediately by intravenous injection.
Danish: Det opløste præparat bør indgives straks ved intravenøs injektion.
English: Do not use CEPROTIN
Danish: Brug ikke CEPROTIN:
English: WATER FOR INJECTIONS
Danish: VAND TIL INJEKTIONSVÆSKER
English: CEPROTIN has no influence on the ability to drive and use machines.
Danish: CEPROTIN påvirker ikke evnen til at føre motorkøretøj og betjene maskiner.
English: Furthermore CEPROTIN is indicated for short-term prophylaxis in patients with severe congenital protein C deficiency if one or more of the following conditions are met:
Danish: Endvidere er CEPROTIN indiceret til korttidsprofylakse hos patienter med alvorlig medfødt protein C mangel, hvis et eller flere af følgende forhold er opfyldt:
English: It is given to you under close supervision of your doctor who is experienced in substitution therapy of coagulation factors/inhibitors and where monitoring of protein C activity is possible.
Danish: Det gives til Dem under tilsyn af en læge med erfaring i erstatningsbehandling med koagulationsfaktorer/inhibitorer, og når overvågning af protein C aktivitet er mulig.
English: Furthermore CEPROTIN is used to prevent thrombosis in patients with severe congenital protein C deficiency if one or more of the following conditions are met:
Danish: Endvidere anvendes CEPROTIN til at forebygge tromboser hos patienter med alvorlig medfødt protein C mangel, hvis et eller flere af følgende forhold er opfyldt:
English: If you stop using CEPROTIN
Danish: Hvis De holder op med at bruge CEPROTIN
English: Although Warfarin-induced skin necrosis can occur in any patient during the initiation of oral anticoagulant therapy, individuals with congenital protein C deficiency are particularly at risk.
Danish: Selvom warfarin-induceret hudnekrose kan forekomme hos enhver patient i løbet af initieringen af oral antikoagulationsbehandling, har personer med medfødt protein C mangel specielt høj risiko (se pkt.
English: If you forget to use CEPROTIN
Danish: Hvis De har glemt at bruge CEPROTIN
English: Human albumin Sodium chloride Sodium citrate.
Danish: Humant albumin Natriumchlorid Natriumcitratdihydrat
English: Protein C from human plasma purified by mouse monoclonal antibodies.
Danish: Protein C fra humant plasma oprenset af monoklonale antistoffer fra mus.
English: Frequency and duration of treatment depend on the severity of your protein C deficiency, on the results of determination of protein C levels in your plasma as well as on the location and extent of thrombosis.
Danish: Hyppighed og varighed af behandling afhænger både af, hvor alvorlig Deres protein C mangel er, resultaterne fra bestemmelse af protein C niveauer i plasma, og hvor tromboserne findes, samt hvor udbredte de er.
English: As with any intravenous protein product, allergic type hypersensitivity reactions are possible.
Danish: Som med andre intravenøse protein produkter er der mulighed for allergiske overfølsomhedsreaktioner.
English: As the risk of an allergic type hypersensitivity reaction cannot be excluded, patients should be informed of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Danish: Da risikoen for en allergisk overfølsomhedsreaktion ikke kan udelukkes, bør patienter informeres om de tidlige tegn på overfølsomhedsreaktioner inklusiv nældefeber, generel urticaria, tæthed for brystkassen, hiven efter vejret, hypotension og anafylaksi.
English: Symptoms of allergy include rash, hives, breathing difficulties, low blood pressure, tightness of chest, and shock.
Danish: Allergiske symptomer omfatter udslæt, nældefeber, vejrtrækningsbesvær, lavt blodtryk, tæthed for brystkassen og shock.
English: Parvovirus B 19 infection may be serious for pregnant women (fetal infection) and for individuals whose immune system is depressed or who have some types of anaemia (e.g. sickle cell disease or haemolytic anaemia).
Danish: Parvovirus B19- infektion kan være alvorlig for gravide kvinder (føtal infektion) og for personer, hvis immunsystem er hæmmet eller som har visse typer af anæmi (f.eks. seglcelleanæmi eller hæmolytisk anæmi).
English: Parvovirus B19 infection may be serious for pregnant women (fetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g. haemolytic anaemia).
Danish: Parvovirus B19 infektion kan være alvorlig for gravide kvinder (føtal infektion) og for personer med immundefekt eller forøget erytropoiese (f.eks. hæmolytisk anæmi).
English: CEPROTIN is used in the treatment and prevention of thrombotic and haemorrhagic skin lesions (named purpura fulminans) in patients with severe congenital protein C deficiency.
Danish: CEPROTIN anvendes til behandling og forebyggelse af trombotiske og hæmoragiske hud læsioner (kaldet purpura fulminans) hos patienter med alvorlig medfødt protein C mangel.
English: The measurement of protein C activity using chromogenic substrates is recommended for the determination of the patient's plasma level for protein C before and during treatment with CEPROTIN.
Danish: Bestemmelsen af protein C aktivitet ved anvendelse af kromogene substrater anbefales til bestemmelse af patientens plasma niveau for protein C inden og under behandling med CEPROTIN.
English: What CEPROTIN contains
Danish: CEPROTIN indeholder:
English: In patients receiving prophylactic administration of protein C, higher trough levels may be warranted in situations of an increased risk of thrombosis (such as infection, trauma, or surgical intervention).
Danish: Hos patienter, der behandles profylaktisk med protein C, kan højere forekomst af lave niveauer være berettiget i situationer med forøget risiko for trombose (som infektion, traume eller kirurgiske indgreb).
English: • one transfer needle • one filter needle
Danish: • en overføringskanyle • en filterkanyle
English: • when coumarin therapy is not feasible.
Danish: • når coumarin terapi alene ikke er gennemførlig.
English: If the preparation is used in patients with severe congenital protein C deficiency, antibodies inhibiting protein C may develop that can inhibit protein C and therefore diminish the effect of the preparation.
Danish: Såfremt præparatet bruges til patienter med alvorlig medfødt protein C mangel, kan der udvikles antistoffer, som hæmmer protein C. Dette kan hæmme protein C og derfor formindske virkningen af produktet.
English: The measurement of protein C activity using chromogenic substrates is recommended for the determination of your plasma level for protein C before and during treatment with CEPROTIN.
Danish: Bestemmelsen af protein C aktivitet ved anvendelse af kromogene substrater anbefales til bestemmelse af Deres plasma niveau for protein C inden og under behandling med CEPROTIN.
English: Powder and solvent for solution for injection One transfer needle and one filter needle
Danish: Pulver og solvens til injektionsvæske, opløsning En overføringskanyle og en filterkanyle
English: The product reconstituted with 10 ml of Sterilised Water for Injections contains approximately 100 IU/ml human protein C.
Danish: Efter opløsning i 10 ml sterilt vand til injektionsvæsker indeholder produktet cirka 100 IE/ml human protein C.
English: If you receive prophylactic administration of protein C, higher trough levels may be warranted in situations of an increased risk of thrombosis (such as infection, trauma, or surgical intervention).
Danish: Hvis De får permanent profylaktisk behandling med protein C, kan højere forekomst af lave niveauer være berettiget i situationer med forøget risiko for trombose (som infektion, traume eller kirurgiske indgreb).
English: Administration
Danish: ADMINISTRATIONSMÅDE
English: System Organ Class Adverse Reaction
Danish: Systemorganklasse Bivirkning
English: 5 ml Sterilised Water for Injections
Danish: 5 ml sterilt vand til injektionsvæsker
English: CEPROTIN 500 IU* is prepared as a powder containing nominally 500 IU human protein C per container.
Danish: CEPROTIN 500 IE* er fremstillet som et pulver indeholdende nominelt 500 IE human protein C per hætteglas.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to mouse protein or heparin, except for control of life-threatening thrombotic complications.
Danish: 6.1, museprotein eller heparin, undtagen ved kontrol af livstruende trombotiske komplikationer.
English: CEPROTIN 1000 IU* is prepared as a powder containing nominally 1000 IU human protein C per container.
Danish: CEPROTIN 1000 IE* er fremstillet som et pulver indeholdende nominelt 1000 IE human protein C per hætteglas.
English: The product reconstituted with 5 ml of Sterilised Water for Injections contains approximately 100 IU/ml human protein C.
Danish: Efter opløsning i 5 ml sterilt vand til injektionsvæsker indeholder produktet cirka 100 IE/ml human protein C.
English: 10 ml Sterilised Water for Injections
Danish: 10 ml sterilt vand til injektionsvæsker
English: If the patient is switched to permanent prophylaxis with oral anticoagulants, protein C replacement is to be discontinued only when stable anticoagulation is obtained (see section 4.5).
Danish: Hvis patienten er skiftet til permanent profylakse med orale antikoagulanter, skal protein C erstatningen kun afbrydes, når stabil antikoagulation er opnået (se pkt.
English: If the preparation is used in patients with severe congenital protein C deficiency, antibodies inhibiting protein C may develop.
Danish: Såfremt præparatet bruges til patienter med alvorlig medfødt protein C mangel, kan der udvikles antistoffer, som hæmmer protein C.
English: Baxter AG A-1221 Vienna, Austria
Danish: Baxter AG A-1221 Wien, Østrig
English: Solvent Sterilised Water for Injections
Danish: Solvens Sterilt vand til injektionsvæsker
English: Nevertheless, please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Hvis De tager eller for nylig har taget andre lægemidler, bør De oplyse Deres læge eller apotek herom, også hvis der er tale om ikke-receptpligtige lægemidler.
English: CEPROTIN is indicated in purpura fulminans and coumarin induced skin necrosis in patients with severe congenital protein C deficiency.
Danish: CEPROTIN er indiceret til purpura fulminans og coumarin-induceret hudnekrose hos patienter med alvorlig medfødt protein C mangel.
English: As with any intravenous product allergic type hypersensitivity reactions are possible.
Danish: Som med ethvert intravenøst produkt er der risiko for allergiske reaktioner.
English: The protein C plasma activity was measured by chromogenic assay.
Danish: Protein C plasma aktivitet blev bestemt ved kromogen analyse.
English: One vial provides 100 IU per ml of human protein C when reconstituted as recommended.
Danish: Et hætteglas indeholder 100 IU per ml af humant protein C efter opløsning ifølge de anbefalede anvisninger.
English: This leaflet was last approved in
Danish: Denne indlægsseddel blev senest ændret den .
English: Patients should be informed of the early signs of hypersensitivity reactions, which may include angioedema, burning and stinging at the injection site, chills, flushing, rash, pruritus, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting and wheezing.
Danish: Patienter bør informeres om tidlige tegn på overfølsomhedsreaktioner, hvilke kan inkludere angioødem, forbrændinger og brænden på injektionsstedet, forkølelse, rødme, udslæt, pruritus, generel urticaria, hovedpine, nældefeber, hypotension, letargi, kvalme, rastløshed, tachykardi, tæthed for brystkassen, prikkende fornemmelse, opkastning og hiven efter vejret.
English: You should be aware of the early signs of allergic reactions such as burning and stinging at the injection site, chills, flushing, rash, hives, breathing difficulty, nausea, headache, lethargy, low blood pressure, and tightness of the chest.
Danish: De bør være opmærksom på tidlige tegn på allergiske reaktioner som forbrændinger og brænden på injektionsstedet, forkølelse, rødme, udslæt, nældefeber, vejrtrækningsbesvær, kvalme, hovedpine, apati, for lavt blodtryk og tæthed for brystkassen.
English: Powder and solvent for solution for injection Human Protein C
Danish: Pulver og solvens til injektionsvæske, opløsning Humant protein C
English: Human albumin, sodium chloride and sodium citrate.2H2O
Danish: Humant albumin, natriumklorid og natriumcitratdihydrat
English: How to use CEPROTIN
Danish: Sådan skal De bruge CEPROTIN
English: Baxter AG Industriestrasse 67 A-1221 Vienna Austria
Danish: BAXTER AG Industriestrasse 67 A-1221 Wien Østrig
English: Reconstitute lyophilised CEPROTIN powder for solution for injection, with the supplied solvent (Sterilised Water for Injections) using the sterile transfer needle.
Danish: Opløs frysetørret CEPROTIN pulver til injektionsvæske, opløsning i den medfølgende solvens (sterilt vand til injektionsvæsker) ved hjælp af den sterile overføringskanyle.
English: For this reason, if the patient is switched to oral anticoagulants, protein C replacement must be continued until stable anticoagulation is obtained.
Danish: Af denne grund skal protein C substitutionen fortsættes, indtil stabil antikoagulation er opnået, hvis patienten stilles om til orale antikoagulanter.
English: The quantity of sodium in the maximum daily dose may exceed 200 mg.
Danish: Da mængden af natrium i den maksimale daglige dosis kan overstige 200 mg, kan det være skadeligt for personer på lav natriumdiæt.
English: • As with any product administered by infusion into a vein allergic reactions including severe and potentially life-threatening reactions (anaphylaxis) are possible.
Danish: • Som med ethvert produkt, der bliver indgivet ved infusion i en vene, er der risiko for allergiske reaktioner.
English: Psychiatric disorders restlessness
Danish: Psykiske forstyrrelser uro
English: Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded.
Danish: På trods af disse forholdsregler kan muligheden for overførsel af smitte ikke helt udelukkes, når der indgives lægemidler fremstillet af humant blod eller plasma.
English: BAXTER AG Industriestrasse 67 A-1221 Vienna Austria
Danish: Baxter AG Industriestrasse 67 A - 1221 Wien Østrig
English: After reconstitution, the solution is drawn through the sterile filter needle into a sterile disposable syringe.
Danish: Efter opløsning overføres opløsningen til den sterile engangssprøjte ved hjælp af den sterile filterkanyle.
English: Sodium chloride: 88 mg/vial Sodium citrate.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Natriumchlorid: 88 mg/hætteglas Natriumcitratdihydrat: 44 mg/hætteglas
English: Sodium chloride: 44 mg/vial Sodium citrate.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Natriumchlorid: 44 mg/hætteglas Natriumcitratdihydrat: 22 mg/hætteglas
English: CEPROTIN is administered by intravenous injection after reconstitution of the powder for solution for injection with Sterilised Water for Injections.
Danish: CEPROTIN gives ved intravenøs injektion efter opløsning af pulveret til injektionsvæske, opløsning i sterilt vand til injektionsvæsker.
English: CEPROTIN should be administered at a maximum injection rate of 2 ml per minute except for children with a body weight of < 10 kg, where the injection rate should not exceed a rate of 0.2 ml/kg/min.
Danish: Hos børn med en legemsvægt på < 10 kg bør injektionshastigheden ikke overstige 0,2 ml/kg/min.
English: CEPROTIN will be administered to you by intravenous injection after reconstitution of the powder for solution for injection with Sterilised Water for Injections.
Danish: CEPROTIN indgives til Dem ved intravenøs injektion efter pulveret til injektionsvæske, opløsning er opløst i sterilt vand til injektionsvæsker.
English: Hypersensitivity Rash
Danish: Overfølsomhed Udslæt
English: CEPROTIN 1000 IU Powder for solution for injection Human Protein C IV
Danish: CEPROTIN 1000 IU Pulver til injektionsvæske, opløsning Human Protein C
English: The intravenous administration of CEPROTIN provides for an immediate but temporary increase in plasma levels of protein C. Replacement of protein C in protein C deficient patients is expected to control or - if given prophylactically - prevent thrombotic complications.
Danish: Ved substitution af protein C hos patienter med protein C mangel forventes, at trombosekomplikationer kontrolleres, eller - hvis det indgives profylaktisk - at trombosekomplikationer forebygges.
English: CEPROTIN 500 IU Powder for solution for injection Human Protein C IV
Danish: CEPROTIN 500 IU Pulver til injektionsvæske, opløsning Human Protein C
English: Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Danish: På trods af dette kan muligheden for overførsel af smitstoffer ikke helt udelukkes, når der indgives lægemidler fremstillet af humant blod eller plasma.
English: What CEPROTIN is and what it is used for What you need to know before you use CEPROTIN How to use CEPROTIN
Danish: Det skal De vide, før De begynder at bruge CEPROTIN Sådan skal De bruge CEPROTIN Bivirkninger
English: The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV and for the non-enveloped virus HAV.
Danish: Forholdsreglerne anses for at være effektive for kapsel vira som HIV, HBV og HCV samt for ikke-kapsel vira HAV. Forholdsreglerne kan være af begrænset værdi over for ikke-kapsel vira som parvovirus B19.
English: The solution is drawn through the sterile filter needle into a sterile disposable syringe.
Danish: Væsken overføres til den sterile engangssprøjte ved hjælp af den sterile filterkanyle.
English: CEPROTIN 500 IU powder and solvent for solution for injection
Danish: CEPROTIN 500 IE Pulver og solvens til injektionsvæske, opløsning.
English: Based on the limited clinical experience in children from reports and studies covering 83 patients, dosing guidelines for adult subjects are considered valid for neonatal and paediatric patient population (see section 5.1).
Danish: Den begrænsede kliniske erfaring fra rapporter og studier omfatter 83 patienter.
English: Sterilised Water for Injections is used.
Danish: Som solvens anvendes sterilt vand til injektionsvæsker.
English: CEPROTIN 1000 IU powder and solvent for solution for injection
Danish: CEPROTIN 1000 IE pulver og solvens til injektionsvæske, opløsning.
English: Intravenous use
Danish: INDRE PAKNING
English: Marketing Authorisation Holder
Danish: Indehaver af markedsføringstilladelsen:
English: If you use more CEPROTIN than you should
Danish: Hvis De har brugt for meget CEPROTIN
English: You should not do both.
Danish: Du bør ikke gøre begge dele.
English: • you are more than 75 years old,
Danish: • du er over 75 år,
English: • feeling tired,
Danish: • du føler dig træt,
English: Statins should be used with caution.
Danish: Statiner bør anvendes med forsigtighed.
English: Date of first authorisation: 26 November 2009 Date of latest renewal:
Danish: Dato for første markedsføringstilladelse: 26. november 2009 Dato for seneste fornyelse:
English: Both compounds bind mainly to albumin.
Danish: Begge stoffer binder hovedsageligt til albumin.
English: • your skin being more sensitive to the sun,
Danish: • din hud bliver mere følsom over for sollys,
English: Take the medicine pack with you.
Danish: Tag medicinpakningen med dig.
English: The following risks:
Danish: Følgende risici:
English: Your heart might beat very slowly or you may feel dizzy.
Danish: Dit hjerte kan slå meget langsomt, eller du kan føle dig svimmel.
English: • Your doctor may also do other blood tests.
Danish: • Din læge kan også tage andre blodprøver.
English: The educational material is a Prescriber Guide to:
Danish: Uddannelsesmaterialet består af en ordinationsvejledning til:
English: • Co-administration with dabigatran
Danish: • Co-administration med dabigatran
English: PC: SN: NN:
Danish: SN: NN:
English: This effect is considered specific to this species and not relevant to humans.
Danish: Denne effekt betragtes som specifik for denne art, og derfor ikke relevant for mennesker.
English: MULTAQ is used only in adults.
Danish: MULTAQ bruges kun af voksne.
English: In most patients this increase occurs early after treatment initiation and reaches a plateau after 7 days.
Danish: Denne stigning forekommer hos de fleste patienter tidligt efter opstart af behandlingen og når et plateau efter 7 dage.
English: There is no specific antidote available.
Danish: Der findes er ingen specifik antidot.
English: Contact immediately your doctor or the nearest emergency department or hospital.
Danish: Kontakt straks din læge eller nærmeste skadestue/hospital.
English: Efficacy and safety were comparable in elderly patients who did not suffer from other cardiovascular diseases and younger patients.
Danish: Effekt og sikkerhed var sammenlignelige hos ældre patienter, der ikke led af andre kardiovaskulære sygdomme, og hos yngre patienter.
English: The following side effects have been reported with this medicine:
Danish: Følgende bivirkninger ved denne medicin er blevet indberettet:
English: Each of these factors has a limited influence on dronedarone.
Danish: Hver af disse faktorer har begrænset indflydelse på dronedaron.
English: Tell your doctor about all the medicines you take.
Danish: Fortæl din læge om al den medicin du tager.
English: Twenty five percent (25%) had AF at baseline.
Danish: 25 % havde AF ved baseline.