FrancophonIA/ELRC3.0 huggingface dataset:
English: Safety was demonstrated in 3-week-old and adult chickens treated with overdoses of up to 5 times the recommended dose for 3 times the recommended duration of treatment.
Danish: Sikkerhed er påvist hos 3 uger gamle kyllinger og fuldvoksne kyllinger, som fik en overdosis på op til 5 gange den anbefalede dosis i 3 gange den anbefalede behandlingsvarighed.
English: Exzolt 10 mg/ml solution for use in drinking water for chickens fluralaner
Danish: Exzolt, 10 mg/ml, opløsning til anvendelse i drikkevand til kyllinger fluralaner
English: Exzolt 10 mg/ml solution for use in drinking water for chickens
Danish: Exzolt, 10 mg/ml, opløsning til anvendelse i drikkevand til kyllinger
English: Withdrawal periods:
Danish: 10. TILBAGEHOLDELSESTIDER
English: No adverse reactions were observed following the treatment of 3-week old and adult chickens dosed with up to 5 times the recommended dose for 3 times the recommended duration of treatment.
Danish: Der blev ikke observeret bivirkninger efter behandlingen af 3 uger gamle kyllinger og fuldvoksne kyllinger, som fik en dosis på op til 5 gange den anbefalede dosis i 3 gange den anbefalede behandlingsvarighed.
English: No negative effects on egg production were observed when layer hens were treated with up to 5 times the recommended dose for 3 times the recommended duration of treatment.
Danish: Der blev ikke observeret uønskede påvirkninger af ægproduktionen ved behandling af æglæggende høns med op til 5 gange den anbefalede dosis i 3 gange den anbefalede behandlingsvarighed.
English: No negative effects on egg production were observed when layer hens were treated with overdoses of up to 5 times the recommended dose for 3 times the recommended duration of treatment.
Danish: Der blev ikke observeret uønskede påvirkninger af ægproduktionen hos æglæggende høns, der blev behandlet med en overdosis på op til 5 gange den anbefalede dosis i 3 gange den anbefalede behandlingsvarighed.
English: There were no adverse effects on reproductive performance when breeding chickens were treated with 3 times the recommended dose for twice the recommended duration of treatment.
Danish: Der var ingen uønskede påvirkninger af reproduktionsevnen ved behandling af avlskyllinger med 3 gange den anbefalede dosis i 2 gange den anbefalede behandlingsvarighed.
English: There were no adverse effects on reproductive performance when breeding chickens were treated with overdoses of 3 times the recommended dose for twice the recommended duration of treatment.
Danish: Der var ingen uønskede påvirkninger af reproduktionsevnen hos avlskyllinger, der blev behandlet med en overdosis på 3 gange den anbefalede dosis i 2 gange den anbefalede behandlingsvarighed.
English: Lot:
Danish: Nyre
English: b Based on 6 patients only.
Danish: b Baseret på kun 6 patienter.
English: Date of first authorisation: 13 November 2013 Date of latest renewal: 30 July 2018
Danish: Dato for første markedsføringstilladelse: 13. november 2013 Dato for seneste fornyelse: 30. juli 2018
English: You can do this by holding them in your hands until they feel as warm as your hands.
Danish: Du kan gøre dette ved at holde dem i dine hænder, indtil de føles lige så varme som dine hænder.
English: Chemical and physical in-use stability have been demonstrated for:
Danish: Der er påvist kemisk og fysisk stabilitet i:
English: Use a new package instead.
Danish: Brug i stedet en ny pakning.
English: Elderly There is no experience in patients >65 years.
Danish: Der er ingen erfaring hos ældre patienter > 65 år.
English: Check the name, strength and colour of the package, to make sure it contains the correct product.
Danish: Kontrollér navnet, styrken og farven på pakningen for at sikre, at den indeholder det rigtige produkt.
English: You must contact your doctor immediately if you have one of the following early symptoms:
Danish: Kontakt straks lægen, hvis du har et af følgende tidlige symptomer:
English: Always use an aseptic technique.
Danish: Anvend altid aseptisk teknik.
English: The following side effects may occur with this medicine.
Danish: De følgende bivirkninger kan forekomme ved dette lægemiddel.
English: t½ (h)
Danish: t½ (t)
English: The injection is given every 2 to 3 days.
Danish: Injektionen gives hver 2. til 3. dag.
English: Incorrect dose administered
Danish: Forkert dosis administreret
English: Frequency of doses (hours)/Duration of therapy (days)
Danish: Hyppighed af doser (timer)/Behandlingsvarighed (dage)
English: Your doctor will calculate your dose for you.
Danish: Din læge vil beregne din dosis.
English: Do not use the powder if the colour has changed.
Danish: Brug ikke pulveret hvis farven er forandret.
English: Do not use NovoEight if either of the above applies to you.
Danish: Brug ikke NovoEight hvis et eller flere af ovenstående gælder for dig.
English: • low blood pressure (having pale and cold skin, fast heartbeat).
Danish: • lavt blodtryk (har bleg og kold hud, hurtig hjertebanken).
English: No other factors were significantly associated with inhibitor development.
Danish: Ingen andre faktorer var signifikant forbundet med inhibitorudvikling.
English: Treatment with NovoEight was shown to be safe and had the intended haemostatic and preventive effect.
Danish: Behandling med NovoEight viste sig at være sikkert og havde den forventede hæmostatiske og forebyggende virkning.
English: In case of shock, standard medical treatment for shock should be implemented.
Danish: I tilfælde af chok skal standard medicinsk behandling for chok følges.
English: The study showed that comparable and consistent results were obtained for both products and that NovoEight can be reliably measured in plasma without the need of a separate NovoEight standard.
Danish: Studiet viste at sammenlignelige og konsistente resultater blev opnået for begge produkter, og at NovoEight kan måles stabilt i plasma uden behov for en separat NovoEight standard.
English: Thrombin then converts fibrinogen into fibrin and a clot can be formed.
Danish: Trombin omdanner herefter fibrinogen til fibrin og en prop kan dannes.
English: 188 out of 238 previously treated patients continued into the safety extension trial.
Danish: 188 ud af 238 tidligere behandlede patienter fortsatte ind i det udvidede sikkerhedsstudie.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than as stated above, unless reconstitution has taken place in controlled and validated aseptic conditions.
Danish: Hvis produktet ikke anvendes straks, er opbevaringstid og opbevaringsbetingelser brugerens ansvar og er normalt ikke mere end angivet ovenfor, medmindre rekonstitutionen har fundet sted under kontrollerede og validerede aseptiske forhold.
English: In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske lægemidler skal det administrerede produkts navn og batchnummer tydeligt registreres.
English: Check the expiry date.
Danish: Kontrollér udløbsdatoen.
English: Talk to your doctor if you are on a controlled sodium diet.
Danish: Tal med din læge, hvis du er på en kontrolleret natriumdiæt.
English: This is of importance particularly when changing the laboratory and/or reagents used in the assay.
Danish: Dette er især vigtigt ved skift af laboratorie og/eller ændring af de reagenser, der anvendes i analysen.
English: You should tell your doctor if you have been previously treated with factor VIII products, especially if you developed inhibitors, since there might be a higher risk that it happens again.
Danish: Du skal fortælle det til din læge, hvis du tidligere er blevet behandlet med et faktor VIII produkt, især hvis du har udviklet inhibitorer, da der kan være en højere risiko for at dette sker igen.
English: BW: Body weight, SD: Standard deviation a Success is defined as either 'Excellent' or 'Good'.
Danish: BW: Legemsvægt, SD: Standardafvigelse a Succes er defineret som enten 'Meget god' eller 'God'.
English: In such cases, it is recommended that a specialised haemophilia centre is contacted.
Danish: Ved sådanne tilfælde anbefales det at kontakte et specialiseret hæmofilicenter.
English: These inhibitors, especially at high levels, stop the treatment working properly and you or your child will be monitored carefully for the development of these inhibitors.
Danish: Disse inhibitorer stopper behandlingen i at virke korrekt, især ved høje niveauer, og du eller dit barn vil blive overvåget nøje for udvikling af disse inhibitorer.
English: If you are pregnant or breastfeeding, think that you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
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, før du bruger dette lægemiddel.
English: The side effects observed in children and adolescents are the same as observed in adults.
Danish: Bivirkningerne observeret hos børn og unge er de samme som dem, der er observeret hos voksne.
English: During storage, the product may be kept at:
Danish: Indenfor opbevaringstiden må produktet opbevares ved:
English: Please record the beginning of storage and the storage temperature on the product carton.
Danish: Notér venligst påbegyndelsen af opbevaringen og opbevaringstemperaturen på produktets karton.
English: If this happens you may need a higher dose of NovoEight or a different medicine to control your bleed.
Danish: Hvis dette sker, har du måske brug for en højere dosis af NovoEight eller en anden type medicin til at kontrollere din blødning.
English: Place the vial on a flat and solid surface.
Danish: Placer hætteglasset på en flad og fast overflade.
English: Wash your hands and dry them properly using a clean towel or air dry.
Danish: Vask dine hænder og tør dem af i et rent håndklæde eller lufttør dem.
English: Of note, annualised bleeding rate (ABR) is not comparable between different factor concentrates and between different clinical studies.
Danish: Det bemærkes, at den årlige blødningsrate (ABR) ikke er sammenlignelig mellem forskellige faktorkoncentrater og mellem forskellige kliniske studier.
English: • blood tests showing changes in the way the liver functions • reactions (redness and itching) around the site where you injected the medicine.
Danish: • blodanalyser der påviser forandringer i leverfunktionen • reaktioner (rødmen og kløe) omkring det sted, hvor du injicerer medicinen.
English: Once the product has been taken out of the refrigerator, the product must not be returned to the refrigerator.
Danish: Når først produktet er blevet taget ud af køleskabet, må det ikke sættes tilbage i køleskabet.
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Danish: Tabel over bivirkninger Nedenstående tabel er i henhold til MedDRA organsystem klassifikationen (SOC og Preferred Term Level).
English: Do not use the equipment without proper training from your doctor or nurse.
Danish: Brug ikke udstyret uden ordentlig undervisning fra din læge eller sygeplejerske.
English: Inject slowly over 2 to 5 minutes.
Danish: Injicér langsomt over 2 til 5 minutter.
English: Do not use the equipment if you suspect it is contaminated.
Danish: Anvend ikke udstyret hvis du har mistanke om, at det er forurenet.
English: It is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells, and prepared without the addition of any human or animal derived protein in the cell culture process, purification or final formulation.
Danish: Det er produceret ved rekombinant DNA teknologi i kinesisk hamsterovarie celler (CHO), og fremstillet uden tilsætning af nogen human- eller animalderiverede proteiner i cellekultur processen, oprensning eller endelig formulering.
English: All pharmacokinetic (PK) studies with NovoEight were conducted after i.v.
Danish: Alle farmakokinetiske (PK) studier med NovoEight blev udført efter i.v.
English: You should contact your doctor if you have missed a dose and do not know how to compensate for this.
Danish: Kontakt lægen, hvis du har glemt en dosis, og du ikke ved, hvordan man kompenserer for dette.
English: If severe, sudden allergic reactions (anaphylactic reactions) occur (very rare), the injection must be stopped immediately.
Danish: Hvis en pludselig allergisk reaktion (anafylaktisk reaktion) opstår (meget sjældent), skal injektionen straks ophøre.
English: If such inhibitors occur, the condition will manifest itself as an insufficient clinical response.
Danish: Hvis sådanne inhibitorer forekommer, vil tilstanden manifestere sig ved et utilstrækkeligt klinisk respons.
English: From a microbiological point of view, the medicinal product should be used immediately after reconstitution.
Danish: Ud fra et mikrobiologisk synspunkt bør produktet anvendes straks efter rekonstitution.
English: Do not open the equipment until you are ready to use it. Do not use the equipment if it has been dropped, or if it is damaged.
Danish: Åbn ikke udstyret før du er klar til at bruge det. Anvend ikke udstyret hvis det har været tabt, eller det er ødelagt.
English: • increased blood pressure
Danish: • forhøjet blodtryk
English: If this happens to you or your child´s medicines may stop working properly and you or your child may experience persistent bleeding.
Danish: Hvis dette sker for dig eller dit barn, kan medicinen stoppe med at virke korrekt, og du eller dit barn kan opleve vedvarende blødning.
English: The specific activity of NovoEight is approximately 8,300 IU/mg protein.
Danish: Den specifikke aktivitet af NovoEight er cirka 8.300 IE/mg protein.
English: A total of 30 surgeries were performed in 25 patients of which 26 were major surgeries and 4 were minor.
Danish: Der blev i alt udført 30 operationer hos 25 patienter, hvoraf 26 var store operationer og 4 var mindre.
English: Intravenous use Read the package leaflet before use
Danish: Intravenøs brug Læs indlægssedlen før brug
English: The assay performance of NovoEight in FVIII:C assays was evaluated and compared to a marketed full length recombinant FVIII product.
Danish: Analysepræstationen af NovoEight i FVIII:C undersøgelsen blev evalueret og sammenlignet med et markedsført fuld længde rekombinant FVIII produkt.
English: The risk of developing inhibitors is correlated to the severity of the disease as well as the exposure to factor VIII, this risk being highest within the first 50 exposure days but continues throughout life although the risk is uncommon.
Danish: Risikoen for udvikling af inhibitorer er relateret til sygdommens sværhedsgrad samt eksponering af faktor VIII, da denne risiko er størst i løbet af de første 50 eksponeringsdage, men fortsætter livet ud, selvom risikoen er ikke almindelig.
English: If, at any point, there is too much air in the syringe, inject the air back into the vial.
Danish: Hvis der på noget tidspunkt er for meget luft i sprøjten skal luften injiceres tilbage i hætteglasset.
English: Haemostasis was successful in all surgeries and no treatment failures were reported.
Danish: Hæmostase var vellykket ved alle operationer og ingen behandlingssvigt blev rapporteret.
English: High risk genetic mutations were identified in 92.3% of the overall and 93.8% of the high titre confirmed inhibitors.
Danish: Genetiske højrisikomutationer blev identificeret hos 92,3% overordnet, og 93,8% af bekræftede højtiterinhibitorer.
English: Surgery There is limited experience of surgery in paediatric patients.
Danish: Der er begrænset erfaring med kirurgi hos pædiatriske patienter.
English: The recommended infusion rate for NovoEight is 1-2 ml/min.
Danish: Den anbefalede infusionsrate for NovoEight er 1-2 ml/min.
English: This will depend on your weight and what the medicine is being used for.
Danish: Din dosis afhænger af din legemsvægt, og hvilken behandling medicinen anvendes til.
English: Follow the instructions for proper use for your connector and CVAD in consultation with your doctor or nurse.
Danish: Følg instruktionen i brug af din forbindelse og CVAD i samråd med din læge eller sygeplejerske.
English: Frequencies have been evaluated according to the following convention: 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
Danish: Hyppigheden er angivet efter følgende konvention: 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), og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: For paediatric patients above the age of 12 the dose recommendations are the same as for adults.
Danish: For pædiatriske patienter over 12 år er anbefalingerne de samme som for voksne.
English: When you prepare and inject medicine directly into the veins, it is important to use a clean and germ free (aseptic) technique.
Danish: Når du klargør og injicerer lægemidlet direkte ind i en vene, er det vigtigt at bruge en ren og bakteriefri (aseptisk) metode.
English: The pharmacokinetic parameters were comparable between paediatric patients below 6 years of age and the paediatric patients from 6 to below 12 years of age.
Danish: De farmakokinetiske parametre var sammenlignelige mellem de pædiatriske patienter under 6 år og de pædiatriske patienter fra 6 til under 12 år.
English: Four multi-centre, open-labelled, non-controlled trials have been conducted to evaluate the safety and efficacy of NovoEight in the prevention and treatment of bleeds and during surgery in patients with severe haemophilia A (FVIII activity ≤1%).
Danish: Fire multicenter, open label, non-kontrollerede studier har været udført for at evaluere sikkerhed og virkningsevne af NovoEight i forebyggelse og behandling af blødninger og under kirurgi i patienter med svær hæmofili A (FVIII aktivitet ≤1%).
English: NovoEight can be used in children of all ages.
Danish: NovoEight kan anvendes til børn i alle aldre.
English: Some variation was observed in the pharmacokinetic parameters of NovoEight between paediatric and adult patients.
Danish: Der blev observeret nogle forskelle i de farmakokinetiske parametre af NovoEight mellem pædiatriske og voksne patienter.
English: In general, all patients treated with coagulation factor VIII products should be carefully monitored for the development of inhibitors by appropriate clinical observation and laboratory test.
Danish: Generelt bør alle patienter i behandling med koagulationsfaktor VIII omhyggeligt overvåges for udvikling af inhibitorer ved passende kliniske observationer og laboratorietests.
English: In adults and adolesents (>12 years) a less frequent regimen (40-60 IU/kg every third day or twice weekly) may be applicable.
Danish: Hos voksne og unge (>12 år) kan det være relevant med et mindre hyppigt behandlingsregime (40-60 IE/kg hver tredje dag eller to gange ugentligt).
English: Factor VIII is a protein naturally found in the blood that helps it to clot.
Danish: Faktor VIII er et protein der findes naturligt i blodet og er medhjælpende til, at det størkner.
English: Locate a suitable site and slowly inject NovoEight into the vein over a period of 2-5 minutes.
Danish: Find et passende sted og injicér NovoEight langsomt i en vene over en periode på 2-5 minutter.
English: Do not use the equipment if it is expired.
Danish: Anvend ikke udstyret hvis det er udløbet.
English: In patients with existing cardiovascular risk factors, substitiution therapy with FVIII may increase the cardiovascular risk.
Danish: Hos patienter med eksisterende kardiovaskulære risikofaktorer kan substitutionsbehandling med FVIII øge den kardiovaskulære risiko.
English: Abbreviations: AUC = area under the factor VIII activity time profile; CL = clearance; t1/2 = terminal half-life; Vss = volume of distribution at steady-state; Cmax = maximum factor VIII activity.
Danish: Forkortelser: AUC = areal under tidsprofil for faktor VIII aktivitet; CL = clearance; t1/2 = terminal halveringstid; Vss = distributionsvolumen ved steady state; Cmax = maksimal faktor VIII-aktivitet.
English: If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for factor VIII inhibitor presence should be performed.
Danish: Hvis det forventede faktor VIII plasmaniveau ikke opnås, eller hvis blødningen ikke er under kontrol med en passende dosis, skal der testes for tilstedeværelse af faktor VIII inhibitorer.
English: OTHER SPECIAL WARNINGS, IF NECESSARY EXPIRY DATE
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER UDLØBSDATO
English: Prepare the vial and the syringe Take out the number of NovoEight packages you need.
Danish: Klargøring af hætteglas og sprøjte Tag det antal NovoEight pakninger, du behøver.
English: Taken out of refrigerator: _____________Stored at ≤30°C __ Stored at 30°C up to 40°C __
Danish: Taget ud af køleskabet: _____________Opbevaret ved ≤30°C __ Opbevaret ved 30°C til 40°C __
English: Individual patients may vary in their response to factor VIII, demonstrating different half-lives and recoveries.
Danish: Patienter kan individuelt variere i deres respons på faktor VIII og udvise forskellige halveringstider og genfinding.
English: • feeling dizzy or loss of consciousness
Danish: • føler dig svimmel eller mister bevidstheden
English: • heart attack.
Danish: • hjerteanfald.
English: Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy and breastfeeding is not available.
Danish: På grund af den sjældne forekomst af hæmofili A hos kvinder er der ingen erfaring med hensyn til anvendelsen af faktor VIII under graviditet og amning.
English: The powder in the vial appears as a white or slightly yellow powder.
Danish: Pulveret i hætteglasset fremstår som et hvidt eller lettere gult pulver.
English: Table 3 Consumption of NovoEight and haemostatic success rates in previously untreated patients (PUP) and previously treated patients (PTP)
Danish: Tabel 3 Forbrug af NovoEight og hæmostatisk succes-rate hos tidligere ubehandlede patienter (PUP) og tidligere behandlede patienter (PTP)
English: Do not disassemble the equipment before disposal.
Danish: Skil ikke udstyret ad før bortskaffelse.
English: The most frequently reported adverse reactions were injection site reactions, incorrect dose administered and hepatic enzymes increased.
Danish: De hyppigst rapporterede bivirkninger var reaktioner ved injektionsstedet, forkert dosis administreret og øgede hepatiske enzymer.
English: This is equivalent to 1.5% of the recommended maximum dietary intake of sodium for an adult.
Danish: Dette svarer til 1,5% af det højst anbefalede indtag af natrium i kosten for en voksen.
English: The factor VIII/von Willebrand factor complex consists of two molecules (factor VIII and von Willebrand factor) with different physiological functions.
Danish: Faktor VIII/von Willebrand faktor komplekset består af to molekyler (faktor VIII og von Willebrand faktor) med forskellige fysiologiske funktioner.
English: Adolescents (above the age of 12) can use the same dose as adults.
Danish: Unge (over 12 år) kan bruge den samme dosis som voksne.
English: Administration of the reconstituted solution
Danish: Administration af den rekonstituerede opløsning
English: Of the 3,293 reported bleeds observed in 298 of the patients, 2,902 (88.1%) of the bleeds were resolved with 1-2 infusions of NovoEight.
Danish: Ud af de 3.293 rapporterede blødninger observeret hos 298 af patienterne, var 2.902 (88,1%) af blødningerne stoppet med 1 til 2 infusioner af NovoEight.
English: Do not use this medicine if you notice that it is cloudy or contains visible particles.
Danish: Brug ikke lægemidlet hvis du opdager, at det er uklart eller indeholder synlige partikler.
English: The higher CL and the shorter t½ seen in paediatric patients compared to adult patients with haemophilia A may be due in part to the known higher plasma volume per kilogram body weight in younger patients.
Danish: Den højere CL og kortere t½ set hos pædiatriske patienter sammenlignet med voksne patienter med hæmofili A kan til dels være på grund af det velkendte højere plasmavolumen per kilogram kropsvægt hos yngre patienter.