FrancophonIA/ELRC3.0 huggingface dataset:
English: The benefits of Rixubis in treating and preventing bleeding episodes have been shown in three main studies involving patients with severe or moderately severe haemophilia B. None of the studies compared the effectiveness of Rixubis directly with another medicine.
Danish: Fordelene ved Rixubis til behandling og forebyggelse af blødningsepisoder er påvist i tre hovedundersøgelser med patienter med svær eller moderat svær hæmofili B. Ingen af undersøgelserne sammenlignede virkningen af Rixubis direkte med andre lægemidler.
English: Rixubis can only be obtained with a prescription and treatment should be started under the supervision of a doctor who has experience in the treatment of haemophilia.
Danish: Rixubis udleveres kun efter recept, og behandlingen bør iværksættes under opsyn af en læge med erfaring i behandling af hæmofili.
English: What are the risks associated with Rixubis?
Danish: Hvilke risici er der forbundet med Rixubis?
English: Rixubis can therefore be used to replace the missing factor IX, giving temporary control of the bleeding disorder.
Danish: Rixubis kan derfor anvendes som erstatning for den manglende faktor IX og giver midlertidig kontrol med blødningsforstyrrelsen.
English: For more information about treatment with Rixubis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Rixubis, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: In some cases, reactions become severe (anaphylaxis) and may be associated with dangerously steep falls in blood pressure.
Danish: I nogle tilfælde kan reaktionerne være svære (anafylakse) og medføre pludseligt og farligt blodtryksfald.
English: The Committee considered that Rixubis had been shown to be effective in preventing and treating bleeding episodes in adults and children with haemophilia B, and was also effective in allowing them to undergo surgery safely.
Danish: Udvalget fandt, at Rixubis er påvist at være effektivt til forebyggelse og behandling af blødningsepisoder hos voksne og børn med hæmofili B, og at det også var effektivt til at muliggøre sikre operationer hos sådanne patienter.
English: Rixubis is a medicine used to treat and prevent bleeding in patients with haemophilia B, an inherited bleeding disorder caused by lack of factor IX.
Danish: Rixubis er et lægemiddel til behandling og forebyggelse af blødning hos patienter med hæmofili B, som er en arvelig blødningsforstyrrelse, der skyldes mangel på faktor IX.
English: For the full list of all side effects with Rixubis see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Rixubis fremgår af indlægssedlen.
English: Rixubis is available as a powder and solvent that are mixed together to make a solution for injection into a vein.
Danish: Rixubis leveres som et pulver med opløsningsvæske (solvens), der blandes sammen til en opløsning, som gives ved injektion i en vene.
English: Patients with haemophilia B lack factor IX, which is needed for blood to clot properly.
Danish: Patienter med hæmofili B mangler faktor IX, der er nødvendig for blodets størkning.
English: What benefits of Rixubis have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Rixubis?
English: For practical information about using Rixubis, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Rixubis, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Rixubis used?
Danish: Hvordan anvendes Rixubis?
English: The dose and frequency of treatment depend on the patient's bodyweight and whether Rixubis is used to treat or prevent bleeding, as well as the seriousness of the haemophilia, the extent and location of the bleeding and the patient's age and health.
Danish: Dosis og hyppighed af behandlingen afhænger af patientens legemsvægt, og af, om Rixubis skal anvendes til behandling eller forebyggelse af blødning.
English: How does Rixubis work?
Danish: Hvordan virker Rixubis?
English: A second study involved 23 children aged from just under 2 to nearly 12 years of age, who experienced 26 bleeding episodes during the study: treatment of bleeding episodes was rated as excellent in 50% of cases and good in another 46%, and the average bleeding rate was reduced from 6.8 to 2.7 bleeds per year.
Danish: Behandlingen af blødningsepisoderne blev bedømt som meget god i 50 % af tilfældene og god i 46 %, og den gennemsnitlige forekomst af blødninger blev mindsket fra 6,8 til 2,7 blødninger årligt.
English: In a third study, Rixubis was given to 14 patients undergoing surgery; treatment with Rixubis kept blood loss during the surgery to levels expected in patients without haemophilia B.
Danish: Ved behandling med Rixubis forblev blodtabet under operationen på samme niveau som den, der forventes hos patienter uden hæmofili B.
English: Nonacog gamma is not extracted from human blood but is made by a method known as ‘recombinant DNA technology': it is made by hamster cells into which a gene (DNA) has been introduced that makes the cells able to produce the human clotting factor.
Danish: Det produceres af hamsterceller, der har fået indsat et gen (DNA), som gør dem i stand til at producere den menneskelige koagulationsfaktor.
English: For full details, see the package leaflet.
Danish: Fuldstændige oplysninger fremgår af indlægssedlen.
English: In particular, only 13 patients (10% of the FVIII arm) received a third generation rFVIII product.
Danish: Navnlig fik kun 13 patienter (10 % af FVIIIarmen) et tredjegenerations rFVIII-produkt.
English: The pdFVIII class consists of products with or without Von Willebrand Factor (VWF), and those with VWF contain a range of VWF levels.
Danish: PdFVIII-klassen består af produkter med eller uden Von Willebrand-faktor (VWF), og produkter med VWF indeholder forskellige mængder af VWF.
English: PRAC also considered grounds submitted by LFB Biomedicaments as basis for their request for re-examination of the PRAC recommendation and the views of two experts meetings held on 22 February and 3 August 2017.
Danish: desuden begrundelsen fra LFB Biomedicaments for dettes anmodning om fornyet overvejelse af PRAC's henstilling, og synspunkterne på to ekspertmøder afholdt den 22. februar og 3. august 2017,
English: • Patient-related risk factors include type of F8 gene mutation, severity of haemophilia, ethnicity, family history of inhibitor development and possibly HLA-DR (Human Leukocyte Antigenantigen D Related) constitution.
Danish: • Til patientrelaterede risikofaktorer hører mutation af F8-genet, hæmofiliens sværhedsgrad, etnicitet, familiær anamnese vedrørende inhibitordannelse, og muligvis HLA-DR-konstitution (Human Leukocyt Antigen-antigen D-relateret konstitution).
English: However, despite the lack of robust evidence to support differential risks between rFVIII products, differential risks cannot be excluded, as this is a heterogeneous product class with differences in composition and formulations.
Danish: Trods den manglende substantielle evidens til underbygning af forskelle i risici mellem forskellige rFVIII-produkter kan forskelle i risiko dog ikke udelukkes, da der er tale om en sammensat produktklasse med forskelle i sammensætning og formulering.
English: Although this became non-significant when UK patients (also included in the RODIN/Pednet study were excluded.
Danish: Denne forskel blev dog ikke-signifikant, når man udelukkede patienter i Det Forenede Kongerige (også dem, der indgik i RODIN/Pednet-undersøgelsen).
English: Like the UKHCDO study, the FranceCoag study also found no statistically significant increased risk for any rFVIII products vs Advate when French patients (also in the RODIN/Pednet study) were excluded.
Danish: Ligesom i UKHCDO-undersøgelsen fandtes der i FranceCoag-undersøgelsen ikke for noget rFVIII-produkt statistisk signifikant højere risiko end for Advate, når man udelukkede franske patienter (også dem, der indgik i RODIN/Pednet-undersøgelsen).
English: Treatment with both pdFVIII and rFVIII can lead to development of inhibitors (tested with the Nijmegen method of the Bethesda assay and defined as ≥0.6 Bethesda units (BU) for “a low titre” inhibitor and >5 BU for a “high-titre” inhibitor).
Danish: Både med pdFVIII og rFVIII kan behandlingen medføre dannelse af inhibitorer (som, ved testning med Nijmegen-metoden i Bethesda-assayet, er defineret som ≥0,6 Bethesda-enheder (BU) for en "lavtiter"inhibitor og > 5 BU for en "højtiter"-inhibitor).
English: Therefore, there is a high degree of uncertainty around extrapolating the SIPPET findings to the entire rFVIII class, particularly for more recently-authorised rFVIII products which were not included in the SIPPET trial.
Danish: Der er derfor stor usikkerhed forbundet med at ekstrapolere resultaterne af SIPPET til hele rFVIII-klassen, især til senere godkendte rFVIII-produkter, der ikke er omfattet af SIPPET-undersøgelsen.
English: However the PRAC is of the view that there are uncertainties with regards to the findings of the SIPPET study which preclude the conclusion that there is a higher risk of inhibitor development in PUPs treated with rFVIII products than pdFVIII products studied in this clinical trial, as detailed below:
Danish: PRAC finder imidlertid, at der er usikkerheder omkring SIPPETundersøgelsens resultater, som udelukker en konklusion om, at risikoen for inhibitordannelse hos tidligere ubehandlede patienter er højere ved behandling med rFVIII-produkter end med de pdFVIIIprodukter, der er anvendt i denne kliniske undersøgelse; dette uddybes nærmere i det følgende:
English: The additional points of clarification provided by the SIPPET authors do not fully resolve this uncertainty.
Danish: Denne usikkerhed ophæves ikke helt af de supplerende præciseringer, der er givet af SIPPET-forfatterne.
English: For high-titre inhibitors, the hazard ratio was 1.69 (95% CI, 0.96 to 2.98).
Danish: For højtiter-inhibitorer var risikoforholdet 1,69 med 95 % SI [0,96; 2,98]).
English: The CANAL study2 found no evidence of a class difference, including pdFVIII products with considerable quantities of von Willebrand factor; for ‘clinically relevant' inhibitors the adjusted hazard ratio was 0.7 (95% CI 0.4-1.1), and for high titre inhibitors (≥5 BU) was 0.8 (95% CI 0.4-1.3).
Danish: I CANAL-undersøgelsen2 fandtes ingen tegn på en klasseforskel, herunder pdFVIII-produkter med betydelige mængder von Willebrand-faktor; for "klinisk relevante" inhibitorer var det justerede risikoforhold 0,7 (med 95 % SI [0,4; 1,1]), og for højtiterhæmmere (≥ 5 BU) 0,8 (med 95 % SI [0,4;
English: The PRAC considered that as a prospective randomised trial, the SIPPET study avoided many of the design limitations of the observational and registry-based studies undertaken so far to evaluate the risk of inhibitor development in PUPs.
Danish: PRAC fandt, at SIPPET-undersøgelsen i kraft af, at den er en prospektiv, randomiseret undersøgelse, har undgået mange af de designbetingede begrænsninger ved de observationsundersøgelser og
English: The SIPPET study was an open-label, randomized, multi-centre, multi-national trial investigating the incidence of neutralising allo-antibodies in patients with severe congenital haemophilia A (plasma FVIII
Danish: SIPPET-undersøgelsen var en åben, randomiseret multinational multicenterundersøgelse af forekomsten af neutraliserende alloantistoffer hos patienter med svær kongenit hæmofili A (FVIIIkoncentration i plasma <1 %) ved anvendelse af enten pdFVIII- eller rFVIII-koncentrat.
English: Many of these studies were small and not specifically designed to evaluate the inhibitor risk in PUPs with severe haemophilia A. The studies were mostly single arm and do not provide data to perform comparative analysis (either between pdFVIII and rFVIII as a class comparison, or within the rFVIII class).
Danish: Undersøgelserne var for størstedelen enkeltarmede og tilvejebringer ikke data til en komparativ analyse (hverken mellem pdFVIII og rFVIII som klassevurdering, eller inden for rFVIII-klassen).
English: (another 3rd generation rFVIII) vs Advate, but only for all inhibitor development.
Danish: Der var desuden evidens for højere risiko med Refacto AF (endnu et 3. generations rFVIII) end med Advate, men kun for al inhibitordannelse.
English: However, the study found evidence of an increased risk of inhibitors (all and high titre) for 2nd generation rFVIII octocog alfa (Kogenate FS/Helixate NexGen) compared with 3rd generation rFVIII octocog alfa (which was driven solely by data for Advate).
Danish: ) for 2. generations rFVIII octocog alfa (Kogenate FS/Helixate NexGen) end for 3. generations rFVIII octocog alfa (dette skyldtes udelukkende data for Advate).
English: This trial, known as the SIPPET study (“Survey of Inhibitors in Plasma-Product Exposed Toddlers”) was conducted to evaluate the relative risk of inhibitors in patients treated with pdFVIII compared to rFVIII.
Danish: Denne undersøgelse er kendt som SIPPET-undersøgelsen ("Survey of Inhibitors in PlasmaProduct Exposed Toddlers") (undersøgelse af inhibitorer hos småbørn, der eksponeres for plasmaprodukter).
English: Results of clinical studies not sufficiently robust (e.g. suffering from methodolical
Danish: Resultater af kliniske undersøgelser, som ikke er tilstrækkeligt substantielle (f.eks. som følge af metodologiske begrænsninger), bør ikke afspejles i produktinformationen for FVIIII-produkter.
English: Inhibitors are less likely to occur in previouslytreated patients (PTPs).
Danish: Hos tidligere behandlede patienter (PTP) er der mindre tendens til forekomst af inhibitorer.
English: • The SIPPET study was not designed to evaluate the risk of inhibitor development for individual products, and included a limited number of FVIII products.
Danish: • SIPPET-undersøgelsens design var ikke beregnet til at vurdere risikoen for inhibitordannelse for de enkelte produkter, og undersøgelsen omfattede kun et begrænset antal FVIII-produkter.
English: The findings from the SIPPET study, as well as those from the individual clinical trials and observational studies, are not sufficient to confirm any consistent statistically and clinically meaningful differences in inhibitor risk between the rFVIII and pdFVIII product classes.
Danish: Resultaterne af SIPPETundersøgelsen såvel som af de enkelte kliniske forsøg og observationsundersøgelser er ikke tilstrækkelige til at bekræfte gennemgående statistisk og klinisk betydningsfulde forskelle i inhibitorrisiko mellem produktklasserne rFVIII og pdFVIII.
English: It found that patients treated with rFVIII products had an 87% higher incidence of all inhibitors than those treated with pdFVIII (which contained VWF) (hazard ratio, 1.87; 95% CI, 1.17 to 2.96).
Danish: 1 F. Peyvandi et al. “A Randomized Trial of Factor VIII and Neutralizing Antibodies in Hemophilia A” N Engl J Med. 2016 May behandlet med rFVIII-produkter, var forekomsten af alle inhibitorer 87 % højere end hos dem, der blev behandlet med pdFVIII (som indeholdt VWF) (risikoforhold 1,87 med 95 % SI [1,17; 2,96]).
English: ATC vet code: QI07AJ06.
Danish: ATCvet-kode: QI07AJ06.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/14/163/001
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/14/163/001
English: Pharmacotherapeutic group: Immunologicals for canidae, live and inactivated viral and inactivated bacterial vaccines.
Danish: Farmakoterapeutisk gruppe: Immunologiske midler til canidae - levende og inaktiverede virus- og inaktiverede bakterievacciner.
English: EXPIRY DATE EXP {month/year}
Danish: UDLØBSDATO EXP måneder/år}
English: Annual re-vaccination is required for Parainfluenza and Leptospira components.
Danish: Årlige revaccinationer er påkrævet for parainfluenza og Leptospira komponenter.
English: Suspension (inactivated) : L. interrogans serovar Icterohaemorrhagiae
Danish: Suspension (inaktiveret): L. interrogans serovar Icterohaemorrhagiae
English: In case of travelling to risk areas or outside the EU, veterinary surgeons may wish to give additional rabies vaccinations after 12 weeks of age to ensure that the vaccinated dogs have an antibody titre of ≥ 0.5 IU/ml, which is generally regarded as sufficiently protective and that they meet the travel test requirements (antibody titres ≥ 0.5 IU/ml).
Danish: I tilfælde af rejser til risikoområder eller ved rejser uden for EU, kan dyrlægen give en ekstra rabiesvaccination efter 12ugers alderen for at sikre, at de vaccinerede hunde har et antistoftiter på ≥ 0,5 IE/ml som generelt anses for tilstrækkelig beskyttelse, og at det opfylder testkrav for rejser(antistoftiter på ≥ 0,5 IE/ml).
English: Two doses of Versican Plus DHPPi/L4R 3-4 weeks apart from 8-9 weeks of age.
Danish: To doser af Versican Plus DHPPi/L4R med 3 til 4 ugers mellemrum fra 8-9-ugers alderen.
English: At least three years following the primary vaccination course for canine distemper virus, canine adenovirus type 1, canine adenovirus type 2, canine parvovirus and rabies.
Danish: Mindst 3 år efter basisvaccination for hundesygevirus, hundeadenovirus type 1, hundeadenovirus type 2, hundeparvovirus og rabies.
English: A single dose of Versican Plus DHPPi/L4R should be given every 3 years.
Danish: En enkeltdosis af Versican Plus DHPPi/L4R bør indgives hvert 3. år.
English: The vaccine is intended for the active immunisation of healthy puppies and dogs against diseases caused by canine distemper virus, canine parvovirus, canine adenovirus type 1 and 2, canine parainfluenza virus, Leptospira interrogans serogroup Australis serovar Bratislava, Leptospira interrogans serogroup Canicola serovar Canicola, Leptospira kirschneri serogroup Grippotyphosa serovar Grippotyphosa, Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, and rabies virus.
Danish: Vaccinen er beregnet til aktiv immunisering af raske hvalpe og hunde mod sygdomme forårsaget af hundesygevirus, hundeparvovirus, hundeadenovirus type 1 og 2, hundeparainfluenzavirus, Leptospira interrogans serogruppe Australis serovar Bratislava, Leptospira interrogans serogruppe Canicola serovar Canicola, Leptospira kirschneri serogruppe Grippotyphosa serovar Grippotyphosa og Leptospira interrogans serogruppe Icterohaemorrhagiae serovar Icterohaemorrhagiae samt rabiesvirus.
English: ADVICE ON CORRECT ADMINISTRATION Aseptically reconstitute the lyophilisate with suspension.
Danish: OPLYSNINGER OM KORREKT ANVENDELSE Rekonstituer lyofilisat med suspension aseptisk.
English: In case of need, dogs younger than 8 weeks can be vaccinated as safety of this product has been demonstrated in 6 weeks old dogs.
Danish: Ved behov kan hunde under 8-uger vaccineres, da sikkerheden af Versican Plus DHPPi/L4R er påvist hos hunde i 6-ugers alderen.
English: At least one year following the primary vaccination course for canine parainfluenza virus and Leptospira components.
Danish: Mindst 1 år efter basisvaccination for CpiV og Leptospira komponenter.
English: PACKAGE LEAFLET: Versican Plus DHPPi/L4R lyophilisate and suspension for suspension for injection for dogs
Danish: INDLÆGSSEDDEL Versican Plus DHPPi/L4R lyofilisat og suspension til injektionsvæske, suspension til hund
English: In this case the second vaccination with Versican Plus DHPPi/L4R should not be given before 12 weeks.
Danish: Den første dosis kan derfor administreres med Versican Plus DHPPi/L4, I så tilfælde bør den anden dosis med Versican Plus DHPPi/L4R ikke administreres tidligere end 12 ugers alderen.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus DHPPi/L4R lyophilisate for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN Versican Plus DHPPi/L4R - lyofilisat - til hund
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus DHPPi/L4R suspension for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN Versican Plus DHPPi/L4R - suspension - til hund
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus DHPPi/L4R lyophilisate and suspension for suspension for injection for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN Versican Plus DHPPi/L4R lyofilisat og suspension til injektionsvæske, suspension til hund
English: Australis serovar Bratislava, - to prevent clinical signs and urinary excretion and reduce infection caused by L. interrogans serogroup Canicola serovar Canicola and L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, - to prevent clinical signs and reduce infection and urinary excretion caused by L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa and - to prevent mortality, clinical signs and infection caused by rabies virus.
Danish: − for at forebygge kliniske symptomer og udskillelse i urinen og reducere infektion forårsaget af L. interrogans serogruppe Canicola og L. interrogans serogruppe Icterohaemorrhagiae serovar Icterohaemorrhagiae
English: Type I glass vial containing 1 dose of lyophilisate closed with a bromobutyl rubber stopper and aluminium cap.
Danish: 6.5 Den indre emballages art og indhold Vaccinen leveres i hætteglas Type I. Hætteglassene med lyofilisat er lukket med en prop af brombutylgummi og et aluminiumlåg.
English: Australis serovar Bratislava, - to prevent clinical signs and urinary excretion and reduce infection caused by L. interrogans serogroup Canicola serovar Canicola and L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, - to prevent clinical signs and reduce infection and urinary excretion caused by L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa, and - to prevent mortality, clinical signs and infection caused by rabies virus.
Danish: − for at forebygge kliniske symptomer og reducere infektion og udskillelse i urinen forårsaget af L. kirschneri serogruppe Grippotyphosa serovar Grippotyphosa og
English: Onset of immunity: - 2 weeks after a single vaccination from 12 weeks of age for rabies, - 3 weeks after the first vaccination for CDV, CAV, CPV, - 3 weeks after completion of the primary course for CPiV and - 4 weeks after completion of the primary course for Leptospira components.
Danish: − 3 uger efter første vaccination for CDV, CAV, CPV
English: The expected benefits of Thymanax are to reduce and gradually remove the symptoms related to your depression.
Danish: De forventede fordele af Thymanax er at reducere og gradvist fjerne symptomer relateret til Deres depression.
English: Thymanax should therefore not be used in these patients.
Danish: Thymanax bør derfor ikke anvendes til disse patienter.
English: The calendar printed on the blister containing the tablets should help you remembering when you last took a tablet of Thymanax.
Danish: Kalenderen, der er trykt på blisterkortet med tabletterne, kan hjælpe Dem til at huske, hvornår De sidst har taget en Thymanax tablet.
English: During your treatment with Thymanax :
Danish: Under Deres behandling med Thymanax:
English: You must not use Thymanax if your liver does not work properly.
Danish: De må ikke tage Thymanax, hvis Deres lever ikke fungerer ordentligt.
English: Thymanax should not be used in children and adolescents (under 18 years old).
Danish: Børn og unge Thymanax bør ikke anvendes til børn og unge (under 18 år).
English: Some patients may get increased levels of liver enzymes in their blood during treatment with Thymanax.
Danish: Nogle patienter kan få forhøjede leverenzymer i blodet under behandling med Thymanax.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Thymanax therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Danish: Der skal tages beslutning om at ophøre med amning eller at seponere/afstå fra behandling med Thymanax under hensyntagen til fordelen for barnet ved amning og fordelen ved behandling for kvinden.
English: 9 DATE OF THE FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation : 19 February 2009
Danish: Dato for første markedsføringstilladelse: 19. februar 2009 Dato for seneste fornyelse af tilladelsen: 7. januar 2019