FrancophonIA/ELRC3.0 huggingface dataset:
English: What benefits of Infanrix hexa have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Infanrix hexa?
English: How does Infanrix hexa work?
Danish: Hvordan virker Infanrix hexa?
English: 5 x (1 x 10 ml) vials
Danish: 5 x (1x10 ml) hætteglas
English: EU number Invented name Strength Pharmaceutical form Route of administration Packaging Content (concentration)
Danish: Særnavn Styrke Lægemiddelform Indgivelsesvej
English: • At the request of the European Medicines Agency;
Danish: • På anmodning fra Det Europæiske Lægemiddelagentur,
English: It is used in certain groups of people:
Danish: Det anvendes hos bestemte grupper af mennesker:
English: You can do this by holding them in your hands until they feel as warm as your hands.
Danish: ved at holde dem i dine hænder, indtil de føles lige så varme som dine hænder.
English: Your doctor might change the dose.
Danish: Din læge kan ændre dosis.
English: • Take out the number of NovoSeven packages you need.
Danish: • Tag det antal NovoSeven pakninger, du behøver.
English: Date of first authorisation: 23 February 1996 Date of latest renewal: 23 February 2006
Danish: Dato for første markedsføringstilladelse: 23. februar 1996 Dato for seneste fornyelse: 23. februar 2006
English: Always wash your hands and ensure that the area around you is clean.
Danish: Vask altid dine hænder og sørg for, at området omkring dig er rent.
English: This should be done right after step J.
Danish: Dette skal gøres umiddelbart efter trin J.
English: From a microbiological point of view, the product should be used immediately.
Danish: Set fra et mikrobiologisk synspunkt bør produktet anvendes straks.
English: Two dosing regimens can be recommended:
Danish: To doseringsregimer anbefales:
English: Positive status indicates at least one positive test at any admission.
Danish: Positiv status angiver mindst én positiv test ved enhver indlæggelse.
English: Clearance appears related with age, therefore in younger patients clearance may be increased by more than 50%.
Danish: Clearance forekommer at være relateret til alder, hvorfor den hos yngre patienter kan være øget med mere end 50%.
English: Monitoring of treatment - laboratory tests
Danish: Monitorering af behandlingen - laboratorieundersøgelser
English: Use a new package instead.
Danish: Brug en ny pakning i stedet.
English: • Check the name, strength and colour of the package, to make sure it contains the correct product.
Danish: • Kontrollér navn, styrke og farve på pakningen for at sikre at den indeholder det rigtige produkt.
English: The mean in vivo plasma recovery was approximately 20%.
Danish: Den gennemsnitlige in vivo plasma recovery var ca. 20%.
English: As a precautionary measure, it is preferable to avoid use of NovoSeven during pregnancy.
Danish: Som en sikkerhedsforanstaltning foretrækkes det at undgå brug af NovoSeven under graviditet.
English: Before treatment with NovoSeven, make sure your doctor knows:
Danish: Inden behandling med NovoSeven, skal du sikre dig, at din læge har kendskab til:
English: In each of these situations, the potential benefit of treatment with NovoSeven should be weighed against the risk of these complications.
Danish: I hver af disse situationer, bør det potentielle udbytte af behandling med NovoSeven opvejes mod risikoen for disse komplikationer.
English: Patients should be informed of the early signs of hypersensitivity reactions.
Danish: Patienter skal informeres om de tidlige tegn på overfølsomhedsreaktioner.
English: In the same registry 3 out of 91 surgical patients experienced thromboembolic events.
Danish: I det samme register oplevede 3 ud af 91 kirurgiske patienter tromboemboliske hændelser.
English: If such symptoms occur, the patient should be advised to discontinue use of the product immediately and contact their physician.
Danish: Hvis sådanne symptomer forekommer, skal patienten rådes til at stoppe brugen af produktet straks og kontakte sin læge.
English: The pharmacokinetic profiles indicated dose proportionality.
Danish: Den farmakokinetiske profil indikerede dosisproportionalitet.
English: However, there is no medical reason to think that it would affect your ability.
Danish: Der er ingen medicinsk årsag til at tro, at det vil påvirke din evne.
English: This reduces the need for hospitalisation and days absent from work and school.
Danish: Det reducerer behovet for indlæggelse og fraværsdage fra skole og arbejde.
English: Current clinical experience does not warrant a general differentiation in dosing between children and adults, although children have faster clearance than adults.
Danish: Nuværende klinisk erfaring giver ikke basis for en generel differentiering i doseringen mellem børn og voksne, selvom børn har en hurtigere clearance end voksne.
English: Invasive procedure/surgery
Danish: Invasiv procedure/kirurgi
English: In some cases, the antibodies showed inhibitory effect in vitro.
Danish: I nogle tilfælde viste antistofferne inhibitorisk effekt in vitro.
English: The dose schedule should not be intentionally increased above the recommended doses due to the absence of information on the additional risk that may be incurred.
Danish: Den planlagte dosis må ikke bevidst øges over de rekommenderede doser, på grund af den manglende information om den yderligere risiko, der kan pådrages.
English: • All steps should be completed under controlled and validated aseptic conditions by adequately trained staff.
Danish: • Alle trin skal udføres under kontrollerede og validerede aseptiske forhold af tilstrækkelligt uddannet personale.
English: • Lack of effect or decreased response to treatment.
Danish: • Manglende virkning eller nedsat respons på behandling.
English: Safety and efficacy of NovoSeven have not been established outside the approved indications and therefore NovoSeven should not be used.
Danish: Sikkerhed og virkning af NovoSeven er ikke påvist uden for de godkendte indikationer, hvorfor NovoSeven ikke bør anvendes.
English: The reconstituted solution has a pH of approximately 6.0.
Danish: Den rekonstituerede opløsning har en pH på ca. 6,0.
English: - Pruritus and urticaria
Danish: - Pruritus og urticaria
English: • The infusion pump must only be operated by trained hospital personnel.
Danish: • Infusionspumpen må kun betjenes af uddannet hospitalspersonale.
English: NovoSeven is a blood coagulation factor.
Danish: NovoSeven er en blodkoagulationsfaktor.
English: Pharmacotherapeutic group: Blood coagulation factors, ATC code: B02BD08
Danish: Farmakoterapeutisk klassifikation: Blodkoagulationsfaktorer, ATC kode: B02BD08
English: The frequencies of both serious and non-serious adverse drug reactions are listed by system organ classes in the table below
Danish: Frekvensen af både alvorlige og ikke alvorlige bivirkninger er anført ud fra systemorganklasser i tabellen nedenfor
English: The risk of a potential interaction between NovoSeven and coagulation factor concentrates is unknown.
Danish: Risikoen for potentiel interaktion imellem NovoSeven og koagulationsfaktorkoncentrater kendes ikke.
English: - Do not freeze.
Danish: - Må ikke fryses.
English: You will usually need hospital care.
Danish: Hospitalsbehandling vil normalt være nødvendig.
English: • Do not use this medicine after the expiry date that is stated on the carton.
Danish: • Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen.
English: In such cases treatment with antihistamines i.v.
Danish: I sådanne tilfælde skal man overveje behandling med antihistaminer i.v.
English: It must be colourless.
Danish: Den skal være farveløs.
English: Safely dispose of the used materials.
Danish: Bortskaf de brugte materialer sikkert.
English: • Each time you use NovoSeven, tell your doctor or hospital as soon as possible.
Danish: • Hver gang du bruger NovoSeven skal du hurtigst muligt indberette dette til din læge eller hospitalet.
English: Do not use NovoSeven at the same time as prothrombin complex concentrates or rFXIII.
Danish: Brug ikke NovoSeven samtidigt med protrombin-kompleks-koncentrater eller rFXIII.
English: In case of shock, standard medical treatment for shock should be implemented.
Danish: I tilfælde af shock skal lægebehandling mod shock gennemføres.
English: • In cases of a mild or moderate bleed, you should treat yourself as early as possible, ideally at home.
Danish: • I tilfælde af svag eller moderat blødning, skal du behandle dig selv så hurtigt som muligt, ideelt i hjemmet.
English: • Do not freeze.
Danish: • Må ikke fryses.
English: Distribution, elimination and linearity
Danish: Fordeling, elimination og linearitet
English: • If bleeding is not controlled within 24 hours, contact your doctor immediately.
Danish: • Hvis blødningen ikke er under kontrol indenfor 24 timer, skal du straks kontakte din læge.
English: * Lack of efficacy (therapeutic response decreased) has been reported.
Danish: * Manglende virkning (nedsat terapeutisk respons) har været rapporteret.
English: MedDRA system organ class
Danish: MedDRA Systemorganklasser
English: • Wash your hands and dry them properly using a clean towel or air dry.
Danish: • Vask dine hænder og tør dem i et rent håndklæde eller lufttør dem.
English: The shelf life for the product packed for sale is 3 years when the product is stored below 25°C.
Danish: Produktets opbevaringstid, pakket med henblik på salg, er 3 år, når produktet opbevares ved temperaturer under 25ºC.
English: For single dose injection
Danish: Til enkeltdosis injektion
English: If allergic or anaphylactic-type reactions occur, the administration should be discontinued immediately.
Danish: Hvis der opstår allergiske eller en type af anafylaktiske reaktioner, skal administration ophøre straks.
English: Start treatment of a bleed as early as possible, ideally within 2 hours.
Danish: Påbegynd behandling af en blødning så hurtigt som muligt, ideelt indenfor 2 timer.
English: The duration of home therapy should not exceed 24 hours.
Danish: Varigheden af patientens “hjemmebehandling” bør ikke overstige 24 timer.
English: • Inject slowly over 2 to 5 minutes.
Danish: • Injicér langsomt over 2-5 minutter.
English: • If you are allergic to eptacog alfa (active compound of NovoSeven) or any of the other ingredients in this medicine (listed in section 6).
Danish: • Hvis du er allergisk over for eptacog alfa (det aktive stof i NovoSeven) eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: A theoretical risk for the development of systemic activation of the coagulation system in patients suffering from underlying diseases predisposing them to DIC cannot be totally excluded.
Danish: En teoretisk risiko for udvikling af systemisk aktivering af koagulationssystemet hos patienter, der lider af en underliggende sygdom, der prædisponerer dem for DIC, kan ikke helt udelukkes.
English: Simultaneous use of prothrombin complex concentrates, activated or not, should be avoided.
Danish: Samtidig brug af protrombinkomplekskoncentrater (aktiverede eller ej) bør undgås.
English: All findings in the preclinical safety programme were related to the pharmacological effect of rFVIIa.
Danish: Alle resultater i det prækliniske sikkerhedsprogram kunne relateres til den farmakologiske effekt af rFVIIa.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you use NovoSeven.
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 anvender NovoSeven.
English: Do not use the equipment if you suspect it is contaminated.
Danish: Brug ikke udstyret hvis du har mistanke om, at det er forurenet.
English: • Changes in some liver and blood tests.
Danish: • Forandringer i nogle lever- og blodanalyser.
English: 1 KIU equals 1,000 IU (International Units).
Danish: 1 KIE svarer til 1.000 IE (internationale enheder).
English: • If you are prone to disseminated intravascular coagulation (DIC, a condition where blood clots develop throughout the blood stream) you must be carefully monitored.
Danish: • Hvis du har vist tendens til dissemineret intravaskulær koagulation (DIC, en tilstand, hvor der udvikles blodpropper overalt i blodbanen), skal du være under omhyggelig overvågning.
English: The dose should be repeated after 2 hours and then at 2 - 3 hour intervals for the first 24 - 48 hours depending on the intervention performed and the clinical status of the patient.
Danish: Doseringen skal gentages efter 2 timer og derefter med 2-3 timers interval de første 24-48 timer alt efter operationen og patientens kliniske status.
English: Based on a non-clinical study (see section 5.3) it is not recommended to combine rFVIIa and rFXIII.
Danish: På baggrund af et ikke-klinisk studie (se pkt 5.3) anbefales det ikke at kombinere rFVIIa og rFXIII.
English: This results in the conversion of prothrombin into large amounts of thrombin independently of tissue factor.
Danish: Dette medfører omdannelse af protrombin til store mængder trombin uafhængigt af vævsfaktor.
English: - Increased fibrin degradation products
Danish: - Øget mængde nedbrydningsprodukt af fibrin
English: In syringe (50 ml polypropylene) in hospital settings only Reconstitution must take place in controlled and validated aseptic conditions by adequately trained staff.
Danish: I sprøjte (50 ml polypropylen), kun i hospitalsregi Rekonstitution skal foregå under kontrollerede og validerede aseptiske forhold af tilstrækkeligt uddannet personale.
English: Talk to your doctor about when to use the injections and how long to keep using them.
Danish: Tal med din læge om, hvornår du skal tage injektionerne, og hvor lang tid behandlingen skal vare.
English: The solvent is a histidine solution.
Danish: Solvensen er en histidin opløsning.
English: The only complication reported in connection with an overdose was a slight transient increase in blood pressure in a 16 year-old patient receiving 24 mg rFVIIa instead of 5.5 mg.
Danish: Den eneste rapporterede komplikation i forbindelse med en overdosis var en lille kortvarig stigning i blodtrykket hos en 16-årig patient, der fik 24 mg rFVIIa i stedet for 5,5 mg.
English: ► If you notice any of these serious side effects, get medical help immediately.
Danish: ► Hvis du opdager nogle af disse alvorlige bivirkninger, skal du søge lægehjælp øjeblikkeligt.
English: Remind your doctor if you have a history of allergic reactions as you may need to be monitored more carefully.
Danish: Fortæl altid lægen, hvis du tidligere har haft allergiske reaktioner, da du måske skal følges mere omhyggeligt.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Danish: Dyrestudier indikerer ikke direkte eller indirekte skadelige virkninger med hensyn til graviditet, embryonal-/fosterudvikling, fødsel eller postnatal udvikling (se pkt.
English: Factor VII deficiency
Danish: Faktor VII-mangel
English: The mean terminal half-life ranged from 3.9 to 6.0 hours.
Danish: Den gennemsnitlige terminale halveringstid varierede fra 3,9 til 6 timer.
English: There is no clinical experience in people over 65 using this single dose.
Danish: Der er ingen klinisk erfaring med patienter over 65 år, der anvender denne dosis.
English: • Place the vial on a flat and solid surface.
Danish: • Placér hætteglasset på en flad og fast overflade.
English: When you prepare and inject medication directly into the vein, it is important to use a clean and germ free (aseptic) technique.
Danish: Når du klargør og injicerer et lægemiddel direkte ind i venen, er det vigtigt at anvende en ren og bakteriefri (aseptisk) fremgangsmetode.
English: An initial dose of 90 µg per kg body weight is recommended and could be administered on the way to the hospital where the patient is usually treated.
Danish: Der anbefales en initialdosis på 90 µg pr. kg legemsvægt, og denne kan administreres på vej til det hospital, hvor patienten normalt behandles.
English: See overleaf for detailed instructions.
Danish: Se næste side for en detaljeret instruktion.
English: • If you have an increased risk of blood clots (thrombosis)
Danish: • Hvis du har en forhøjet risiko for blodpropper (trombose)
English: • Allergic, hypersensitivity or anaphylactic reactions.
Danish: • Allergi, overfølsomhed eller anafylaktiske reaktioner.
English: Treatment with NovoSeven, alone or in combination with antifibrinolytics and/or platelets, was defined as effective when bleeding was stopped for at least 6 hours.
Danish: Behandling med NovoSeven, alene eller i kombination med antifibrinolytika og/eller trombocytter, blev defineret som effektiv, når blødningen blev stoppet i mindst 6 timer.
English: There are no clinical data available on interaction between rFVIIa and rFXIII.
Danish: Der foreligger ingen kliniske data om interaktion mellem rFVIIa og rFXIII.
English: If devices other than those supplied by Novo Nordisk are used, ensure the use of an adequate filter with a pore size of 25 micrometer.
Danish: Hvis der anvendes udstyr, som ikke leveres fra Novo Nordisk, skal der bruges et passende filter med en porestørrelse på 25 mikrometer.
English: • An in-line filter with a 5 micrometer pore size must be ensured for administration.
Danish: • Et in-line-filter med en porestørrelse på 5 mikrometer er nødvendigt til administration.
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with NovoSeven should be made taking into account the benefit of breast-feeding to the child and the benefit of NovoSeven therapy to the woman.
Danish: Ved beslutning om at fortsætte/ophøre med at amme eller fortsætte/seponere behandling med NovoSeven, skal der tages hensyn til barnets fordele ved amningen og kvindens gavn af behandling med NovoSeven.
English: • If you are allergic to mouse, hamster or cow proteins (such as cows' milk).
Danish: • Hvis du er allergisk over for muse-, hamster- eller okseproteiner (såsom komælk).
English: Handling procedures for both presentations are described below.
Danish: Håndteringsvejledning for begge pakninger er beskrevet nedenfor.
English: Thromboembolic events may lead to cardiac arrest.
Danish: Tromboemboliske hændelser kan medføre hjertestop.
English: Calcium chloride dihydrate Glycylglycine
Danish: Kalciumchloriddihydrat Glycylglycin
English: Haemophilia A or B with inhibitors or expected to have a high anamnestic response
Danish: Hæmofili A eller B med inhibitorer eller forventet at have høj anamnetisk respons
English: The equipment in this package is designed to reconstitute and inject NovoSeven.
Danish: Udstyret i denne pakning er designet til at opblande og injicere NovoSeven.
English: Adverse drug reactions reported post-marketing only (i.e. not in clinical trials) are presented with a frequency of ‘not known'.
Danish: Bivirkinger som kun er rapporteret post-marketing (dvs. ikke i kliniske studier) er angivet med frekvensen `ikke kendt´.
English: Store below 25°C Do not freeze
Danish: Opbevares under 25 °C Må ikke fryses
English: • If not reconstituted, pooled or used as recommended the in-use times and conditions prior to use are the responsibility of the user.
Danish: • Hvis produktet ikke rekonstitueres, pooles eller anvendes som anbefalet, er opbevaringstidentiden og -betingelserne før anvendelse brugerens ansvar.
English: • Reconstitute the product as described above under Reconstitution for relevant product presentation.
Danish: • Rekonstituér produktet som beskrevet ovenfor under Rekonstitution for den relevante variant af produktet.
English: The excretion of rFVIIa in milk has not been studied in animals.
Danish: Udskillelsen af rFVIIa i mælk er ikke undersøgt hos dyr.
English: In most cases of blood clots, the patients were predisposed to blood clotting disorders.
Danish: I de fleste tilfælde af blodpropper havde patienterne i forvejen tendens til blodpropslidelser.
English: Explain that you have been using NovoSeven.
Danish: Fortæl at du har brugt NovoSeven.
English: The mechanism of action includes the binding of factor VIIa to exposed tissue factor.
Danish: Virkningsmekanismen inkluderer en binding af faktor VIIa til eksponeret vævsfaktor.
English: Dosing frequency should initially be every second hour until clinical improvement is observed.
Danish: Dosisfrekvensen bør initialt være hver 2. time, indtil klinisk effekt er observeret.
English: NovoSeven is supplied as a powder.
Danish: NovoSeven leveres som pulver.
English: At least three doses should be administered to secure effective haemostasis.
Danish: Der bør gives mindst 3 doser for at opnå effektiv hæmostase.
English: To achieve the best results, follow the prescribed dose carefully.
Danish: For at opnå den bedste behandling, skal du følge den ordinerede dosis nøje.
English: Therefore, higher doses of rFVIIa may be needed in paediatric patients to achieve similar plasma concentrations as in adult patients (see section
Danish: Derfor kan det være nødvendigt at indgive en højere dosis af rFVIIa til pædiatriske patienter for at opnå en plasmakoncentration, der svarer til den hos voksne (se pkt.
English: Injecting the solution H
Danish: Injektion H
English: • Repeat the above procedure with the remaining vials with reconstituted product, to obtain the desired volume in the syringe.
Danish: • Gentag ovenstående procedure med de resterende hætteglas med rekonstitueret produkt for at opnå det ønskede volumen i sprøjten.
English: It is unknown whether rFVIIa is excreted in human breast milk.
Danish: Det vides ikke, hvorvidt rFVIIa udskilles i human mælk.
English: If bleeding is not kept under control hospital care is mandatory.
Danish: Hvis blødningen ikke holdes under kontrol, er hospitalsbehandling nødvendig.
English: Usually severe bleeds are treated at the hospital and you can give yourself the first NovoSeven dose on the way there.
Danish: Normalt behandles alvorlige blødninger på hospitalet, og du kan injicere den første NovoSeven dosis på vejen dertil.
English: Administer the solution as an intravenous bolus injection over 2 - 5 minutes.
Danish: Giv opløsningen som intravenøs bolusinjektion over 2-5 minutter.
English: Ensure that the syringe, the infusion tube and the in-line filter are primed and free of air before administration.
Danish: Sørg for, at sprøjten, infusionsslangen og in-line-filteret er klargjort og fri for luft inden administration.
English: This complex activates factor IX into factor IXa and factor X into factor Xa, leading to the initial conversion of small amounts of prothrombin into thrombin.
Danish: Dette kompleks aktiverer faktor IX til faktor IXa og faktor X til faktor Xa, som initierer omdannelsen af små mængder protrombin til trombin.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Indenfor hver grupperet frekvens er bivirkninger angivet i forhold til aftagende alvorlighed.
English: • If you have Factor VII deficiency
Danish: • Hvis du har faktor VII-mangel
English: Data from non-clinical studies as well as post-marketing data show no indication that rFVIIa has a harmful effect on male or female fertility.
Danish: Data fra ikke-kliniske studier såvel som post-marketing data viser ingen indikation på at rFVIIa har en skadelig effekt på fertiliteten hos begge køn.
English: Although NovoSeven will be stable for 24 hours after it has been mixed, you should use it at once to avoid infection.
Danish: Selvom NovoSeven er holdbart i 24 timer efter blanding, bør det anvendes straks for at undgå infektion.
English: After administration of rFVIIa, prothrombin time (PT) and activated partial thromboplastin time (aPTT) have been shown to shorten, however no correlation has been demonstrated between PT and aPTT and clinical efficacy of rFVIIa.
Danish: Efter indgivelse af rFVIIa har protrombin-tid (PT) og aktiveret partiel tromboplastin-tid (aPTT) vist sig at blive forkortede, men der er ikke påvist nogen korrelation mellem PT og aPTT og den kliniske effekt af rFVIIa.
English: - Coagulopathy
Danish: - Koagulopati