FrancophonIA/ELRC3.0 huggingface dataset:
English: In these cases, a fourth injection is recommended 12 months after the first dose.
Danish: I disse tilfælde anbefales det at give en fjerde injektion 12 måneder efter den første dosis.
English: Twinrix Adult has been studied in three main studies involving 843 healthy people aged between 18 and 60 years, most of whom were under 40 years of age.
Danish: Twinrix Voksen blev undersøgt i tre hovedundersøgelser med 843 raske personer mellem 18 og 60 år, hvoraf de fleste var under 40 år.
English: In exceptional cases, the three injections can be given over three weeks for adults needing rapid protection before travelling.
Danish: De tre injektioner kan undtagelsesvis gives over tre uger til voksne, der har behov for hurtigt at opnå beskyttelse, før de skal ud at rejse.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Danish: Vacciner fungerer ved at lære kroppens naturlige forsvar (immunsystemet), hvordan det forsvarer sig mod en sygdom.
English: This means that the viruses and surface antigens are fixed onto aluminium compounds, to stimulate a better response.
Danish: Dvs. at virus og overfladeantigener er bundet til aluminiumsforbindelser for at fremkalde en bedre reaktion.
English: Each person received Twinrix Adult doses at months 0, 1 and 6.
Danish: Hver person fik en dosis Twinrix Voksen ved måned 0, 1 og 6.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) TWINRIX ADULT EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) TWINRIX VOKSEN EPAR - sammendrag for offentligheden
English: The recommended vaccination schedule for Twinrix Adult is three doses, with a gap of one month between the first two doses and a gap of five months between the second and third.
Danish: Det anbefalede vaccinationsprogram for Twinrix Voksen er tre doser med en måneds mellemrum mellem de to første doser og fem måneders mellemrum mellem den anden og den tredje dosis.
English: It is used in adults and adolescents from 16 years of age who are not already immune to these two diseases and who are at risk of contracting both of them.
Danish: Den anvendes til voksne og unge fra 16 år og derover, som ikke allerede er immune over for disse to sygdomme, og som er i risiko for at få dem. Lægemidlet udleveres kun efter recept.
English: It should never be injected into a vein.
Danish: Injektionen må aldrig gives i en blodåre.
English: The European Commission granted a marketing authorisation valid throughout the EU to GlaxoSmithKline Biologicals s.a. for Twinrix Adult on 20 September 1996.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Twinrix Voksen til GlaxoSmithKline Biologicals s.a. den 20. september 1996.
English: For hepatitis B, antibodies were detected in 71% of adults after the first dose, 97% after the second dose and 99.7% after the third dose.
Danish: Der blev påvist antistoffer mod hepatitis B hos 71 % af de voksne efter den første dosis, 97 % efter den anden dosis og 99,7 % efter den tredje dosis.
English: When a person is given the vaccine, the immune system recognises the viruses and surface antigens as ‘foreign' and makes antibodies against them.
Danish: Når en person bliver vaccineret, opfatter immunsystemet vira og overfladeantigener som fremmede og danner antistoffer mod dem.
English: The most common side effects with Twinrix Adult (seen in more than 1 in 10 doses of the vaccine) are headache, pain and redness at the injection site, and fatigue (tiredness).
Danish: De almindeligste bivirkninger ved Twinrix Voksen (set ved flere end 1 ud af 10 doser vaccine) er hovedpine, ømhed og rødme på injektionsstedet og træthed.
English: Twinrix Adult should not be used in people who may be hypersensitive (allergic) to any of the active substances, to any of the other ingredients or to neomycin (an antibiotic).
Danish: Twinrix Voksen bør ikke anvendes af personer, der kan være overfølsomme (allergiske) over for et af de aktive stoffer, et af de øvrige indholdsstoffer eller antibiotikummet neomycin.
English: It is recommended that individuals who receive the first dose should complete all doses of Twinrix Adult.
Danish: Det anbefales, at personer, der får den første dosis, gennemfører hele Twinrix Voksen-programmet.
English: The studies showed that for hepatitis A, antibodies were detected in 94% of adults after the first dose, 99.5% after the second dose and 100% after the third dose.
Danish: Undersøgelserne viste, at der blev påvist antistoffer mod hepatitis A hos 94 % af de voksne efter den første dosis, 99,5 % efter den anden dosis og 100 % efter den tredje dosis.
English: Twinrix Adult is a vaccine.
Danish: Twinrix Voksen er en vaccine.
English: Other information about Twinrix Adult:
Danish: Andre oplysninger om Twinrix Voksen:
English: The full EPAR for Twinrix Adult can be found here.
Danish: Den fuldstændige EPAR for Twinrix Voksen findes her.
English: Twinrix Adult is a vaccine, which is available as a suspension for injection.
Danish: Twinrix Voksen er en vaccine, der fås som en suspension til injektion.
English: The active substances in Twinrix Adult have been available in the European Union (EU) for a number of years in separate vaccines: Havrix Adult for protection against hepatitis A and Engerix-B for protection against hepatitis B.
Danish: De aktive stoffer i Twinrix Voksen har været på markedet i EU i en årrække i forskellige vacciner, f.eks. Havrix Voksen til beskyttelse mod hepatitis A og Engerix-B til beskyttelse mod hepatitis B.
English: The vaccine is injected into the muscle of the upper arm.
Danish: Vaccinen gives som en injektion i overarmsmusklen.
English: A booster dose of Twinrix Adult, or of a separate hepatitis A or B vaccine may be given, according to official recommendations.
Danish: Der kan gives en boosterdosis (forstærkningsdosis) af Twinrix Voksen eller af en separat vaccine mod hepatitis A eller B i overensstemmelse med officielle anbefalinger.
English: It is available in a 1 ml vial and in a 1 ml prefilled syringe.
Danish: Vaccinen fås i hætteglas med 1 ml og som en fyldt injektionssprøjte med 1 ml.
English: Twinrix Adult is used to protect against hepatitis A and hepatitis B infection (diseases that affect the liver).
Danish: Twinrix Voksen anvendes til at beskytte mod infektion med hepatitis A og hepatitis B, der begge er sygdomme, som påvirker leveren.
English: It contains inactivated (killed) hepatitis A viruses and parts of the hepatitis B virus as active substances.
Danish: Som aktive stoffer indeholder den inaktiveret (dræbt) hepatitis A-virus og dele af hepatitis B-virus.
English: The three-week vaccination schedule also led to the production of antibodies in around 83% of patients, rising to around 89% after the booster dose at month 12.
Danish: Treugers-vaccinationsprogrammet medførte også produktion af antistoffer hos omkring 83 % af patienterne.
English: Twinrix Adult contains small amounts of inactivated hepatitis A viruses and the ‘surface antigen' (proteins from the surface) of the hepatitis B virus.
Danish: Twinrix Voksen indeholder små mængder inaktiveret hepatitis A-virus og proteiner fra overfladen af hepatitis B-virus, såkaldte overfladeantigener.
English: For the full list of all side effects reported with Twinrix Adult, see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Twinrix Voksen fremgår af indlægssedlen.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Twinrix Adult's benefits are greater than its risks for use in non-immune adults and adolescents of 16 years of age and above who are at risk of both hepatitis A and hepatitis B infection.
Danish: Udvalget for Humanmedicinske Lægemidler konkluderede, at fordelene ved Twinrix Voksen opvejer risiciene ved anvendelse til ikke-immune voksne og unge fra 16 år og derover, som har risiko for at få en infektion med hepatitis A og hepatitis B. Udvalget anbefalede udstedelse af markedsføringstilladelse for Twinrix Voksen.
English: Further studies looked at the persistence of antibodies after vaccination in adults and adolescents, and at the schedule for vaccinating adults over three weeks when rapid protection is required.
Danish: Det primære mål for virkningen var andelen af personer, der udviklede antistoffer mod hepatitis A og B. I yderligere undersøgelser så man nærmere på persistensen af antistoffer hos voksne og unge efter vaccinationen og på vaccinationsprogrammet over tre uger for voksne med behov for hurtig beskyttelse.
English: Why has Twinrix Adult been approved?
Danish: Hvorfor blev Twinrix Voksen godkendt?
English: What is the risk associated with Twinrix Adult?
Danish: Hvilken risiko er der forbundet med Twinrix Voksen?
English: The surface antigens of the hepatitis B virus are produced by a method known as ‘recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
Danish: Dvs. at de produceres af en gærart, der har fået indsat et gen (dna), som gør den i stand til at producere proteinerne.
English: It should also not be used in people who have had an allergic reaction after being given hepatitis A or hepatitis B vaccines.
Danish: Den bør heller ikke anvendes til personer, der har haft en overfølsomhedsreaktion efter at være blevet vaccineret mod hepatitis A eller hepatitis B. Vaccination med Twinrix Voksen skal udskydes hos patienter med pludseligt opstået, alvorlig feber.
English: The antibodies will help to protect against diseases caused by these viruses.
Danish: Når immunsystemet efterfølgende udsættes for disse vira, vil det være i stand til hurtigere at producere antistoffer mod dem. Antistofferne hjælper med at beskytte mod de sygdomme, der fremkaldes af disse vira.
English: How has Twinrix Adult been studied?
Danish: Hvordan blev Twinrix Voksen undersøgt?
English: What is Twinrix Adult?
Danish: Hvad er Twinrix Voksen?
English: What is Twinrix Adult used for?
Danish: Hvad anvendes Twinrix Voksen til?
English: How is Twinrix Adult used?
Danish: Hvordan anvendes Twinrix Voksen?
English: What benefit has Twinrix Adult shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Twinrix Voksen?
English: How does Twinrix Adult work?
Danish: Hvordan virker Twinrix Voksen?
English: The application was submitted in the concerned member state (UK) under the mutual recognition procedure.
Danish: Ansøgningen blev indgivet til den berørte medlemsstat (Det Forenede Kongerige) i henhold til den gensidige anerkendelsesprocedure.
English: Canazole clotrimazole cream was authorised in Ireland on 8 December 2000 under Article 4.8 (a) (iii) of Directive 65/65/EEC.
Danish: Canazol clotrimazol creme blev godkendt i Irland den 8. december 2000 i henhold til artikel 4, stk. 8, litra a), punkt iii), i direktiv 65/65/EØF.
English: It is therefore considered that the particulars submitted in support of the application do not comply with article 10 of Directive 2001/83/EC as amended.
Danish: Det konkluderedes derfor, at de oplysninger, der blev fremsendt til støtte for ansøgningen, ikke var i overensstemmelse med artikel 10 i direktiv 2001/83/EF med senere ændringer.
English: In addition, the CHMP considered that the preservative efficacy test lacked the methodological details which would allow a correct interpretation.
Danish: Desuden mente CHMP, at den bevarende effektivitetstest manglede de metodologiske detaljer, der ville kunne muliggøre en korrekt fortolkning.
English: It was not possible to discuss variability between and within batches of the test and reference products as information on the necessary batches of each product was not provided.
Danish: Det var ikke muligt at drøfte variabiliteten mellem og inden for batcher af test- og referencelægemidler, da der ikke blev fremlagt information om de nødvendige bachter for hvert lægemiddel.
English: The totality of data submitted does not support the conclusion that the product is therapeutically equivalent.
Danish: De samlede fremsendte data støtter ikke konklusionen om, at lægemidlet er terapeutisk ækvivalent.
English: Canazole Clotrimazole Cream 1% w/w is an anti-fungal agent indicated for the treatment of superficial fungal skin and mucous membrane infections, such as candidiasis, dermatophytoses and commensal yeast infections.
Danish: Canazol Clotrimazol creme 1 % w/w er et lægemiddel mod svampeinfektioner indiceret til behandling af overfladiske svampeinfektioner i hud og slimhinder som f.eks. candidainfektioner, dermatofyter og kommensale gærinfektioner.
English: At the time of the initial authorisation, the need for therapeutic equivalence studies was waived based on quality data demonstrating that the proposed formulation was similar to the reference product with respect to formulation (except the benzyl alcohol concentration), pH and viscosity of the cream, globule size of the dispersed oil phase and size of the active substance present as particles.
Danish: På tidspunktet for den oprindelige godkendelse blev der dispenseret fra kravet om terapeutiske ækvivalensundersøgelser på grundlag af kvalitetsdata, der viste, at den foreslåede formulering svarede til referencelægemidlet med hensyn til formulering (med undtagelse af benzylalkoholkoncentrationen), cremens pH og viskositet, dråbestørrelsen i den opløste oliefase og størrelsen af det aktive stof, der findes som partikler.
English: Differences in droplets size and their possible effect in tissue penetration were not explained.
Danish: Forskelle i dråbestørrelse og deres mulige virkning på vævspenetrationen var ikke forklaret.
English: Comparative in vitro microbial tests to investigate the antimicrobial nature of the drug product were not provided.
Danish: Komparative, mikrobiologiske in vitro test til undersøgelse af lægemidlets antimikrobielle karakter blev ikke fremsendt.
English: The Committee further considered that it is not possible, on the basis of the data submitted in support of this application, to establish a positive benefit-risk balance for this product and, in these circumstances, the marketing of the product constitutes a risk to public health.
Danish: CHMP mente desuden ikke, at det var muligt på grundlag af de fremsendte data til støtte for denne ansøgning at etablere et positivt benefit/risk-forhold for dette lægemiddel, og at markedsføringen af lægemidlet under disse omstændigheder udgør en risiko for folkesundheden.
English: An appropriate skin permeation or similar in vitro studies should have been performed to investigate this matter.
Danish: En passende undersøgelse af hudpermeabilitet eller tilsvarende in vitro undersøgelser burde have været gennemført for at undersøge dette spørgsmål.
English: Key pharmaceutical parameters, such as the dissolution of drug substance in the oily phase were not appropriately validated.
Danish: Farmaceutiske nøgleparametre såsom opløsning af lægemiddelstoffet i oliefasen var ikke valideret korrekt.
English: The CHMP considered the comparative quality data and a preservative efficacy test (in vitro) to demonstrate comparable anti-fungal activity provided.
Danish: CHMP vurderede de fremsendte komparative kvalitetsdata og en bevarende effektivitetstest (in vitro) til påvisning af en sammenlignelig svampeinfektionsbekæmpende aktivitet.
English: The CHMP noted that inconsistent data were provided regarding the state of the drug substance in the drug product and critical quality attributes were not satisfactorily addressed.
Danish: CHMP bemærkede, at der var fremlagt inkonsekvente data vedrørende lægemiddelstoffets form i lægemidlet, og kritiske kvalitetselementer var ikke behandlet tilfredsstillende.
English: The comparative quality data provided and the preservative efficacy test were, therefore, not considered sufficient to justify a waiver of the need to demonstrate therapeutic equivalence by clinical studies or other validated model, and these were therefore deemed necessary in this case to prove equivalence.
Danish: De fremsendte komparative kvalitetsdata og den bevarende effektivitetstest blev derfor ikke anset for at være tilstrækkelige til at berettige en dispensation fra kravet om at påvise terapeutisk ækvivalens ved hjælp af kliniske undersøgelser eller andre validerede modeller, og disse blev derfor anset for at være nødvendige i dette tilfælde for at bevise ækvivalensen.
English: However, the need for a therapeutic equivalence study or other validated model for the formulation to prove equivalence was considered essential by the concerned member state and the matter was referred to the CHMP.
Danish: Den berørte medlemsstat fandt dog en terapeutisk ækvivalensundersøgelse eller en anden valideret model for formuleringen, der kunne bevise ækvivalensen, nødvendig, og sagen blev indbragt for CHMP.
English: This overview was last updated in February 2019.
Danish: Dette sammendrag blev senest ajourført i februar 2019.
English: It is recommended to treat cats in the evening.
Danish: Det anbefales at behandle katte om aftenen.
English: The medicine must be kept in its packaging until use, in order to prevent access by children.
Danish: Lægemidlet skal opbevares i emballagen, indtil det skal bruges, for at forhindre børn i at få adgang til det.
English: On the day of treatment, treated cats must not be allowed to sleep in the same bed as their owner, especially children.
Danish: På behandlingsdagen må behandlede katte ikke sove i samme seng som deres ejer, navnlig børn.
English: Children must not be allowed to play with treated cats for 4 hours after treatment.
Danish: Børn må ikke lege med behandlede katte i fire timer efter behandlingen.
English: Used pipettes of the medicine must be disposed of immediately.
Danish: Brugte lægemiddelpipetter skal straks bortskaffes.
English: The strength and number of pipettes used depends on the weight of the cat being treated.
Danish: Styrken og antallet af pipetter, der anvendes, afhænger af den behandlede kats vægt.
English: Felisecto Plus received a marketing authorisation valid throughout the EU on 26 April 2019.
Danish: Felisecto Plus fik en markedsføringstilladelse med gyldighed i hele EU den 26/04/2019.
English: This small volume of liquid is absorbed through the skin and has an effect throughout the animal's body.
Danish: Denne lille mængde væske absorberes gennem huden og virker i hele dyrets krop.
English: This medicine is the same as Stronghold Plus, which is already authorised in the European Union (EU).
Danish: Lægemidlet er identisk med Stronghold Plus, som allerede er godkendt i Den Europæiske Union (EU).
English: Treated animals must not be touched until the application area is dry.
Danish: Behandlede dyr må ikke berøres, før påføringsstedet er tørt.
English: In case of skin or eye contact, the affected area should be rinsed immediately with water.
Danish: I tilfælde af hud- eller øjenkontakt skal det berørte område omgående skylles med vand.
English: Further information on Felisecto Plus can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/felisecto-plus.
Danish: Yderligere oplysninger om Felisecto Plus findes på agenturets websted under: ema.europa.eu/medicines/veterinary/EPAR/felisecto-plus.
English: This authorisation was based on the authorisation granted to Stronghold Plus in 2017 (‘informed consent').
Danish: Markedsføringstilladelsen var baseret på den tilladelse, som blev udstedt for Stronghold Plus i 2017 ("informeret samtykke").
English: It can also be used as part of a treatment for flea allergy dermatitis (an allergic reaction to flea bites)
Danish: Det kan desuden anvendes som led i behandling af loppebetinget allergisk dermatitis (en allergisk reaktion på loppebid)
English: Because ticks must start feeding on the cat in order to be killed by the medicine, the risk of transmission of diseases that they may carry cannot be excluded.
Danish: Da flåter skal begynde at suge næring fra katten for at blive dræbt af lægemidlet, kan det ikke udelukkes, at de kan overføre sygdomme, som de kan være inficeret med.
English: If the product is accidentally swallowed by a person, the advice of a doctor should be sought immediately.
Danish: Hvis en person utilsigtet indtager lægemidlet, bør der straks søges læge.
English: Sarolaner is effective against ticks and fleas.
Danish: Sarolaner er effektivt mod flåter og lopper.
English: The company that makes Stronghold Plus has agreed that its scientific data can be used for Felisecto Plus (‘informed consent').
Danish: Virksomheden, som fremstiller Stronghold Plus, har indvilget i, at dens videnskabelige oplysninger må anvendes for Felisecto Plus ("informeret samtykke").
English: Use of the medicine may result in mild and short-lived itching at the application site.
Danish: Brugen af lægemidlet kan medføre en let og forbigående kløe på påføringsstedet.
English: Felisecto Plus must only be used when there is a need to treat ticks and one or more of the above parasites.
Danish: Felisecto Plus må kun anvendes, når det er nødvendigt at behandle for flåter og en eller flere af ovennævnte parasitter.
English: Felisecto Plus must not be used in cats suffering from other diseases or in cats that are weak and underweight (for their age).
Danish: Felisecto Plus må ikke anvendes til katte, der lider af andre sygdomme, eller som er svage og undervægtige (i forhold til deres alder).
English: People with sensitive skin or who are hypersensitive (allergic) to selamectin or sarolaner should handle Felisecto Plus with caution.
Danish: Personer med følsom hud, eller som er overfølsomme (allergiske) over for selamectin eller sarolaner, bør håndtere Felisecto Plus med forsigtighed.
English: Felisecto Plus is highly flammable and should be kept away from heat, sparks, any open flame or other sources of ignition.
Danish: Felisecto Plus er meget brandfarligt og skal holdes på afstand af varme, gnister, enhver form for åben ild eller andre antændelseskilder.
English: The European Medicines Agency decided that Felisecto Plus's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur afgjorde, at fordelene ved Felisecto Plus opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: The most common side effects with Felisecto Plus (which may affect up to 1 in 100 cats) are mild to moderate alopecia (hair loss) at the application site, erythema (reddening of the skin) and drooling.
Danish: De hyppigste bivirkninger ved Felisecto Plus (som kan optræde hos op til 1 ud af 100 dyr) er let til moderat alopeci (hårtab) på påføringsstedet, erytem (rødme i huden) og savlen.
English: In order to be exposed to selamectin and sarolaner, fleas and ticks must commence feeding on the cat's blood.
Danish: For at lopper og flåter kan blive udsat for selamectin og sarolaner, skal de først begynde at tage næring fra kattens blod.
English: Other information about Felisecto Plus
Danish: Andre oplysninger om Felisecto Plus
English: The effectiveness of Felisecto Plus was investigated in a field study in cats naturally infested with fleas.
Danish: Virkningen af Felisecto Plus blev undersøgt i et feltstudie med katte, der var naturligt angrebet af lopper.
English: Felisecto Plus is a medicine used to treat mixed infestations with both ticks and other parasites that may be found on the skin or fur of cats, such as fleas, ear mites and lice and/or worms that can enter and infect the body.
Danish: Felisecto Plus er et lægemiddel, der anvendes til behandling af blandede angreb med både flåter og andre parasitter, som kan findes på kattes hud eller pels, såsom lopper, øremider og lus og/eller orm, der kan trænge ind i kroppen og inficere den. Lægemidlet kan anvendes til:
English: • to treat and prevent flea infestations.
Danish: • behandling og forebyggelse af loppeangreb.
English: This results in uncontrolled activity of the nervous system and the paralysis and death of the parasites.
Danish: Dette medfører ukontrolleret aktivitet i nervesystemet, så parasitterne lammes og dør.