FrancophonIA/ELRC3.0 huggingface dataset:
English: Nervous system disorders Common (≥ 1/100 to < 1/10)
Danish: Nervesystemet Almindelig (≥ 1/100 til < 1/10)
English: Dilution of the reconstituted product with sodium chloride 0.9%, solution for injection
Danish: Fortynding af det rekonstituerede produkt med 0,9% natriumchlorid-injektionsvæske
English: Pull the plunger to draw the solvent into the syringe.
Danish: Træk stemplet tilbage for at trække solvensen ind i sprøjten.
English: NovoThirteen 2500 IU powder for injection catridecacog
Danish: NovoThirteen 2500 IE pulver til injektionsvæske catridecacog i.v.
English: Push the plunger slowly to inject the solvent into the powder vial.
Danish: Tryk stemplet langsomt ind for at overføre solvensen til hætteglasset med pulver.
English: The dose volume for the reconstituted NovoThirteen diluted with 6 ml sodium chloride 0.9%, solution for injection can be calculated from this formula:
Danish: Dosismængden af det opblandede NovoThirteen der er fortyndet med 6 ml 0,9% natriumchloridinjektionsvæske, kan beregnes ud fra følgende formel:
English: Tell your doctor if you are using, have recently used or might use any other medicines.
Danish: Brug af anden medicin sammen med NovoThirteen Fortæl altid lægen, hvis du bruger anden medicin eller har gjort det for nylig.
English: If you forget to use NovoThirteen
Danish: Hvis du har glemt at bruge Novo Thirteen
English: To dilute the reconstituted NovoThirteen the following tools are needed: a vial containing sodium chloride 0.9%, solution for injection, a 10 ml syringe and alcohol swabs.
Danish: Til fortynding af det rekonstituerede NovoThirteen skal følgende redskaber bruges: et hætteglas med med 0,9% natriumchlorid-injektionsvæske, en 10 ml sprøjte og alkoholservietter.
English: The signs may include: hives, itching, swelling, difficulty breathing, low blood pressure (signs include paleness and coldness of skin, rapid heartbeat), feeling dizzy and sweating.
Danish: • Hvis du får en allergisk reaktion (er overfølsom) over for NovoThirteen, kan symptomerne være: Nældefeber, kløe, hævelser, vejrtrækningsproblemer, lavt blodtryk (symptomer inkluderer bleg og kold, hurtig hjerterytme), svimmelhed og svedafsondring.
English: Carefully draw exactly 6 ml sodium chloride 0.9%, solution for injection, into the 10 ml syringe.
Danish: Træk omhyggeligt præcist 6 ml 0,9% natriumchlorid-injektionsvæske ind i 10 ml sprøjten.
English: NovoThirteen 2500 IU powder and solvent for solution for injection catridecacog (recombinant coagulation factor XIII)
Danish: NovoThirteen 2500 IE pulver og solvens til injektionsvæske, opløsning catridecacog (rekombinant koagulationsfaktor XIII)
English: Attach the vial adapter to the solvent vial (water for injections).
Danish: Sæt hætteglasadapteren på hætteglasset med solvens (vand til injektionsvæsker).
English: Remove the empty solvent vial by tipping the syringe with the vial adapter.
Danish: Fjern det tomme hætteglas til solvens ved at vippe sprøjten med hætteglasadapteren.
English: Thromboembolic risk:
Danish: Tromboemboliske risici
English: Considering that the posology and the FXIII concentration in NovoThirteen are different from those of the other FXIII containing products, careful attention should be paid to the calculation of the appropriate dose for the individual patient (see dose volume formula provided in section 4.2).
Danish: Der skal foretages omhyggelig beregning af en passende dosis til den enkelte patient, således at der tages højde for, at dosering og koncentration af FXIII i NovoThirteen er forskellig fra andre produkter indeholdende FXIII (se den angivede formel på dosisvolumen i pkt 4.2.
English: In case a dilution of the reconstituted NovoThirteen is needed proceed to the section ‘Dilution of the reconstituted product with sodium chloride 0.9%, solution for injection'.
Danish: I tilfælde af at der er behov for at fortynde det opblandede NovoThirteen, skal du gå videre til afsnittet 'Fortynding af det opblandede produkt med 0,9% natriumchlorid-injektionsvæske
English: The dose volume in millilitres should be calculated based on body weight for each patient using the following formula: Dose volume in ml = 0.042 x subject bw (kg) if bw > 24 kg or dose volume in ml = 0.117 x bw (kg) if bw < 24 kg).
Danish: Dosisvolumen til injektion (i milliliter) skal beregnes til den enkelte patient ud fra legemsvægt efter nedenstående formel: Dosisvolumen i milliliter = 0,042 x personens legemsvægt (kg).
English: Musculoskeletal and connective tissue disorders Common (≥ 1/100 to < 1/10)
Danish: Knogler, led, muskler og bindevæv Almindelig (≥ 1/100 til < 1/10)
English: Dose volume in ml = 0.042 x subject bw (kg)
Danish: Dosismængde i ml = 0,042 x personens legemsvægt (kg)
English: What NovoThirteen looks like and contents of the pack NovoThirteen is supplied as a powder and solvent for solution for injection (2500 IU powder in a vial and 3.2 ml solvent in a vial, with a vial adapter).
Danish: NovoThirteen leveres som pulver og solvens til injektionsvæske, opløsning (2500 IE pulver i et hætteglas og 3,2 ml solvens i et hætteglas, med en hætteglasadapter).
English: For children weighing less than 24 kg the reconstituted NovoThirteen should be further diluted with 6 ml of sodium chloride 0.9%, solution for injection to be able to handle the dosing of small children.
Danish: For børn der vejer under 24 kg, skal det opblandede NovoThirteen fortyndes med yderligere 6 ml 0,9% natriumchlorid-injektionsvæske, for at håndtere doseringen til små børn.
English: • Warning and precautions regarding anaphylaxis
Danish: • Advarsler og forholdsregler vedrørende anafylakse
English: Inhibitor formation:
Danish: Udvikling af inhibitorer
English: Remove the protective paper from the vial adapter without taking the vial adapter out of the protective cap.
Danish: Fjern beskyttelsespapiret fra hætteglasadapteren, og lad beskyttelseslåget sidde på hætteglasadapteren.
English: Hold the syringe slightly tilted with the vial facing downwards.
Danish: Hold sprøjten let skråt med hætteglasset nedad.
English: Dose volume in millilitres = 0.117 x body weight in kilograms.
Danish: Dosismængden i milliliter = 0,117 x legemsvægt i kilogram.
English: Slowly inject the 6 ml sodium chloride 0.9%, solution for injection, into the reconstituted NovoThirteen vial.
Danish: Injicér langsomt de 6 ml 0,9% natriumchlorid-injektionsvæske ned i hætteglasset med det opblandede NovoThirteen.
English: Animal studies are insufficient with respect to reproductive toxicity (see section 5.3) as NovoThirteen has not been studied in pregnant animals.
Danish: 5.3), da NovoThirteen ikke er undersøgt hos drægtige dyr.
English: One vial contains catridecacog (recombinant coagulation factor XIII) (rDNA): 2500 IU per 3 ml, after reconstitution corresponding to a concentration of 833 IU/ml.
Danish: Et hætteglas indeholder catridecacog (rekombinant koagulationsfaktor XIII) (rDNA): 2500 IE per 3 ml, svarende til en koncentration på 833 IE/ml efter rekonstitution.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag 1: Produktresumé, pkt.
English: Click the vial adapter, still attached to the syringe onto the powder vial.
Danish: Klik hætteglasadapteren fast på hætteglasset med pulver, mens den stadig sidder fast på sprøjten.
English: Although expressed in the same unit (IU), the posology of NovoThirteen is different from the dosing schedule of the other FXIII containing products (see section 4.4).
Danish: Doseringen af NovoThirteen er forskellig fra doseringsregimer for andre produkter indeholdende FXIII, selv om det er udtrykt i samme enhed (IE) (se pkt.
English: NAME OF THE MEDICINAL PRODUCT NovoThirteen 2500 IU powder and solvent for solution for injection catridecacog (rDNA factor XIII)
Danish: NovoThirteen 2500 IE pulver og solvens til injektionsvæske, opløsning catridecacog (rDNA faktor XIII)
English: How to use NovoThirteen
Danish: Sådan skal du bruge NovoThirteen
English: One vial contains catridecacog (recombinant coagulation factor XIII) (rDNA) 2500 IU per 3 ml, after reconstitution corresponding to a concentration of 833 IU/ml.
Danish: Et hætteglas indeholder catridecacog (rekombinant koagulationsfaktor XIII) (rDNA) 2500 IE per 3 ml, svarende til en koncentration på 833 IE/ml efter opblanding.
English: If the patient weighs less than 24 kg, the reconstituted NovoThirteen should be diluted with 6 ml of sodium chloride 0.9%, solution for injection (refer to the section Use in the paediatric population for further detailed instructions on the dilution step).
Danish: Hvis patienten vejer mindre end 24 kg, skal det opblandede NovoThirteen fortyndes med 6 ml 0,9% natriumchlorid-injektionsvæske (se under punktet Brug hos den pædiatriske population for yderligere instruktion i hvordan det fortyndes).
English: IV use after reconstitution
Danish: anvendelse efter opblanding
English: Dose volume in millilitres = 0.042 x your body weight in kilograms.
Danish: Dosismængde i milliliter = 0,042 x personens legemsvægt i kilogram.
English: Dose volume in ml = 0.117 x body weight in kilograms.
Danish: Dosisvolumen i ml = 0,117 x legemsvægt i kilogram.
English: Safely dispose of the syringe, vial adapter, infusion set and vials.
Danish: Sprøjte, hætteglasadapter, infusionssæt og hætteglas kasseres på en forsvarlig måde.
English: If you forget an injection of NovoThirteen, talk to your doctor.
Danish: Kontakt lægen, hvis du har glemt en injektion med NovoThirteen.
English: If you have any further questions on the use of this medicine, ask your doctor.
Danish: Spørg lægen, hvis der er noget, du er i tvivl om i forbindelse med brugen af dette lægemiddel.
English: Screw the syringe tightly onto the vial adapter on the solvent vial.
Danish: Skru sprøjten godt fast på hætteglasadapteren på hætteglasset med solvens.
English: The diluted solution is a clear, colourless solution.
Danish: Opblandet NovoThirteen er en klar, farveløs opløsning.
English: • Summary of Product Characteristics.
Danish: • Produktresumé.
English: Inhibitor formation to NovoThirteen therapy has not been detected in clinical trials.
Danish: Der er ikke under kliniske studier påvist udvikling af inhiberende antistoffer mod behandling med NovoThirteen.
English: FXIII containing products (the recommended dose of NovoThirteen is 35 IU/kg body weight
Danish: • Advarsel omkring forskelle i både dosering og koncentration mellem NovoThirteen og andre produkter indeholdende FXIII (den anbefalede dosis er 35 IE/kg legemsvægt en gang månedligt, givet som en intravenøs bolusinjektion.
English: Any residual material of the diluted product has to be discarded immediately.
Danish: Eventuelt resterende injektionsvæske skal straks kasseres.
English: • Package Leaflet.
Danish: • Indlægsseddel.
English: Gently swirl the vial to mix the solution.
Danish: Sving forsigtigt hætteglasset for at rekonstituere opløsningen.
English: If the paediatric patient weighs less than 24 kg, the reconstituted NovoThirteen should be diluted with 6 ml of sodium chloride 0.9%, solution for injection to be able to handle the dosing of small children (see section 4.2 ‘Posology and method of administration - Paediatric population').
Danish: Hvis den pædiatriske patient vejer mindre end 24 kg, skal det rekonstituerede NovoThirteen fortyndes med 6 ml 0,9% natriumchlorid-injektionsvæske, for at kunne håndtere doseringen til små børn (se pkt.
English: What NovoThirteen is and what it is used for What you need to know before you use NovoThirteen How to use NovoThirteen
Danish: Det skal du vide, før du begynder at bruge NovoThirteen Sådan skal du bruge NovoThirteen Bivirkninger
English: Posology
Danish: Se punkt
English: What NovoThirteen is
Danish: NovoThirteen
English: These symptoms may be a sign of a serious allergic reaction.
Danish: Disse symptomer kan være tegn på en alvorlig allergisk reaktion.
English: Date of first authorisation: 31 July 2013
Danish: Dato for første markedsføringstilladelse: 31. juli 2013
English: In this case, your doctor will postpone the vaccination until you are feeling better.
Danish: I dette tilfælde vil din læge udskyde vaccinationen, indtil du har det bedre.
English: Status to be reported annually within each annual reassessment application
Danish: Status skal rapporteres årligt i hver årlig genvurderingsansøgning
English: • if you are ill with a high temperature.
Danish: • hvis du er syg med høj feber.
English: ACAM2000 was administered via scarification.
Danish: ACAM2000 blev administreret via skarifikation.
English: Seroconversion by ELISA and PRNT were as follows:
Danish: Serokonversion med ELISA og PRNT var følgende:
English: Therefore, dose intervals of less than 4 weeks should be avoided.
Danish: Derfor skal dosisintervaller på under 4 uger undgås.
English: Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du får denne vaccine, da den indeholder vigtige oplysninger.
English: The following information is intended for healthcare professionals only: Instructions for preparation and administration of the vaccine:
Danish: Nedenstående oplysninger er til læger og sundhedspersonale: Instruktioner i forberedelse og administration af vaccinen:
English: The use of this vaccine should be in accordance with official recommendations.
Danish: Denne vaccine bør anvendes i overensstemmelse med officielle retningslinjer.
English: Contact a doctor immediately, or go immediately to the emergency department of your nearest hospital if you experience any of the following symptoms:
Danish: Kontakt straks en læge eller tag øjeblikkeligt på skadestuen på dit nærmeste hospital, hvis du oplever nogle af de følgende symptomer:
English: Expiry date depends on storage temperature.
Danish: Udløbsdatoen afhænger af opbevaringstemperaturen.
English: Adverse reactions from all clinical trials are listed according to the following frequency:
Danish: Bivirkninger fra alle kliniske studier er anført i henhold til følgende frekvens:
English: Pack size of 20.
Danish: Pakningsstørrelse på 20.
English: There are inadequate data to determine the appropriate timing of booster doses.
Danish: Der foreligger utilstrækkelige data til at bestemme den hensigtsmæssige timing af booster-doser.
English: If you are a pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask to your doctor for advice.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds.
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Danish: Dette er en godkendelse under særlige omstændigheder, og i henhold til artikel 14, stk. 8, i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. det er i det væsentlige natrium-frit.
English: Visually inspect the suspension prior to administration.
Danish: Inspicer suspensionen visuelt før administration.
English: The most common side effects reported were at the site of injection.
Danish: De mest almindeligt rapporterede bivirkninger var på injektionsstedet.
English: • spinning sensation (vertigo),
Danish: • snurrende fornemmelse (vertigo),
English: Denmark tel fax +45 3326 8380 e-mail regulatory@bavarian-nordic.com
Danish: Danmark tlf. fax +45 3326 8380 e-mail regulatory@bavarian-nordic.com
English: Tell your doctor or nurse if you are taking or have recently taken any other medicines or if you have recently received any other vaccine.
Danish: Fortæl altid lægen eller sundhedspersonalet, hvis du tager anden medicin eller har gjort det for nylig, eller hvis du for nylig har fået andre vacciner.
English: • You will receive one injection.
Danish: • Du vil få én injektion.
English: When a person is given the vaccine, the immune system (the body's natural defence system) will produce its own protection in the form of antibodies against the smallpox virus.
Danish: Når en person får vaccinen, vil immunsystemet (kroppens naturlige forsvarssystem) producere dens egen beskyttelse i form af antistoffer mod koppevirus.
English: Immunisation should be postponed in individuals suffering from an acute severe febrile illness or acute infection.
Danish: Immunisering bør udskydes hos personer, der lider af akut, svær, febril sygdom eller akut infektion.
English: Efficacy in animals
Danish: Virkning hos dyr
English: *represents seropositivity rates
Danish: *viser seropositivitetsrater
English: If you already have atopic dermatitis, you may experience more intense local skin reactions (such as redness, swelling and itching) and other general symptoms (such as headache, muscle pain, feeling sick or tired), as well as a flare-up or worsening of your skin condition.
Danish: Hvis du allerede har atopisk dermatitis, kan du opleve mere intense lokale hudreaktioner (såsom rødme, hævelse og kløe) samt andre generelle symptomer (såsom hovedpine, muskelsmerter, kvalme eller træthed), eller en opblussen eller forværring af din hudsygdom.
English: No interaction studies with other vaccines or medicinal products have been performed.
Danish: Der er ikke udført interaktionsstudier med andre vacciner eller lægemidler.
English: The vaccine will be injected under the skin, preferably into the upper arm, by your doctor or a nurse.
Danish: Denne vaccine vil indsprøjtes under huden, helst i overarmen, af din læge eller sundhedspersonale.
English: Pharmacotherapeutic group: Vaccine, other viral vaccines, ATC code: J07BX
Danish: Farmakoterapeutisk klassifikation: Vaccine, andre virale vacciner, ATC-kode: J07BX
English: This means that because of scientific reasons it has been impossible to get complete information on this medicine.
Danish: Det betyder, at det på grund af videnskabelige årsager ikke har været muligt at opnå fuldstændig dokumentation for lægemidlet.
English: • Make sure you complete the vaccination course of two injections.
Danish: • Sørg for, at du gennemfører vaccinationsprogrammet med to injektioner.
English: • if you have HIV infection or any other condition or treatment leading to a weakened immune system.
Danish: • hvis du har hiv-infektion eller har andre sygdomme eller får anden behandling, der fører til et svækket immunsystem
English: Non-clinical data reveal no special hazard for humans based on repeated dose toxicity, local tolerance, female fertility, embryo-foetal and postnatal toxicity.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra toksicitet efter gentagne doser, lokal tolerance, kvindelig fertilitet, embryoføtal- og postnatal toksicitet.
English: Individuals with atopic dermatitis (AD)
Danish: Personer med atopisk dermatitis (AD)
English: If a booster dose is considered necessary then a single dose of 0.5 ml should be administered.
Danish: Hvis en booster-dosis anses for nødvendig, skal der administreres en enkelt dosis på 0,5 ml.
English: Peripheral sensory neuropathy Somnolence
Danish: Migræne Perifer sensorisk neuropati Somnolens
English: Long-term immunogenicity in humans
Danish: Langvarig immunogenicitet hos mennesker
English: However, your doctor will assess whether the possible benefit in terms of preventing smallpox would outweigh the potential risks of giving you this vaccine.
Danish: Din læge vil imidlertid vurdere, om de mulige fordele med hensyn til at forebygge kopper vil opveje de mulige risici ved at give dig vaccinen.
English: You can be given this vaccine whether or not you have received smallpox vaccination in the past.
Danish: Du kan få denne vaccine uanset om du tidligere har fået koppevaccine.
English: The presence of a minor infection, such as a cold, should not require postponement of the vaccination, but talk to your doctor or nurse first.
Danish: Tilstedeværelsen af en mindre infektion, såsom en forkølelse, bør ikke gøre det nødvendigt at udskyde vaccinationen, men tal først med lægen eller sundhedspersonalet.
English: Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000)
Danish: Almindelig (≥ 1/100 til < 1/10) Ikke almindelig (≥ 1/1.000 til < 1/100) Sjælden (≥ 1/10.000 til < 1/1.000)
English: The presence of a minor infection and/or low-grade fever should not result in the deferral of vaccination.
Danish: Tilstedeværelsen af mild infektion og/eller lav feber bør ikke føre til, at vaccinationen udskydes.
English: It must not be injected into a blood vessel.
Danish: Den må ikke indsprøjtes i en blodåre.
English: • You will receive two injections.
Danish: • Du vil få to injektioner.
English: There is no information on the effect of IMVANEX on your ability to drive or use machines.
Danish: Der er ingen information om virkningen af IMVANEX på din evne til at føre motorkøretøj eller betjene maskiner.
English: The other ingredients are: trometamol, sodium chloride, and water for injections.
Danish: Øvrige indholdsstoffer: trometamol, natriumchlorid og vand til injektionsvæsker.
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
Danish: Som ved alle vacciner til injektion, skal relevant lægebehandling og overvågning altid være til umiddelbar rådighed i tilfælde af sjældne anafylaktiske reaktioner efter administration af vaccinen.
English: The suspension should be visually inspected for particulate matter and discoloration before use.
Danish: Suspensionen bør inspiceres visuelt for partikler og misfarvning før brug.
English: Gently swirl for at least 30 seconds.
Danish: Svinges forsigtigt rundt i mindst 30 sekunder.
English: The concomitant administration of the vaccine with any immunoglobulin including Vaccinia Immune Globulin (VIG) has not been studied and should be avoided.
Danish: Samtidig administration af vaccinen og andre immunoglobuliner, herunder Vaccinia Immune Globulin (VIG) er ikke undersøgt og bør undgås.
English: Most of them were mild to moderate in nature and resolved without any treatment within seven days.
Danish: De fleste af dem var lette til moderate og forsvandt uden behandling i løbet af 7 dage.
English: There are limited data (less than 300 pregnancy outcomes) from the use of IMVANEX in pregnant women.
Danish: Der er ikke tilstrækkelige data (mindre end 300 gravide forsøgspersoner) fra anvendelse at IMVANEX til gravide kvinder.
English: To ensure adequate monitoring of safety and/or effectiveness, the applicant should perform the following studies to collect data where IMVANEX is used as a prophylactic vaccine and/or use in case of re-emergence of circulating smallpox.
Danish: For at sikre tilstrækkelig overvågning af sikkerhed og/eller virkning, skal ansøgeren udføre de følgende studier for at indsamle data, hvor IMVANEX anvendes som en profylaktisk vaccine og/eller anvendelse, hvis cirkulerende kopper dukker op igen.
English: If you miss a scheduled injection, tell your doctor or nurse and arrange another visit.
Danish: Hvis du glemmer en skemalagt injektion, skal du fortælle det til lægen eller sundhedspersonalet, og arrangere et andet besøg.
English: Booster Dose
Danish: Booster-dosis
English: Individuals with atopic dermatitis developed more local and general symptoms after vaccination (see section 4.8)
Danish: Personer med atopisk dermatitis udviklede mere lokale og generelle symptomer efter vaccination (se pkt.
English: Primary immunisation
Danish: Primær immunisering
English: Adverse Reactions Reported in Completed Clinical Trials with IMVANEX (N = 7,082 subjects)
Danish: Bivirkninger rapporteret i gennemførte kliniske studier med IMVANEX (N = 7.082 personer)