FrancophonIA/ELRC3.0 huggingface dataset:
English: This means that it is similar to a ‘reference medicine' containing the same active substance, tobramycin; however, Vantobra has a higher amount of the active substance.
Danish: Det betyder, at det er identisk med et "referencelægemiddel", som indeholder det samme aktive stof, men Vantobra har et højere indhold af det aktive stof.
English: What measures are being taken to ensure the safe and effective use of Vantobra?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Vantobra?
English: The results of the study showed that Vantobra can be considered comparable to Tobi.
Danish: Resultaterne af studiet viste, at Vantobra kan betragtes som sammenligneligt med Tobi.
English: The European Medicines Agency decided that Vantobra's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Vantobra opvejer risiciene, og det kan godkendes til anvendelse i EU.
English: The active substance in Vantobra, tobramycin, belongs to the group of antibiotics known as ‘aminoglycosides'.
Danish: Det aktive stof i Vantobra, tobramycin, tilhører en gruppe af antibiotika kaldet aminoglykosider.
English: The reference medicine for Vantobra is Tobi.
Danish: Referencelægemidlet for Vantobra er Tobi.
English: An overview of Vantobra and why it is authorised in the EU
Danish: En oversigt over Vantobra, og hvorfor det er godkendt i EU
English: It works by interfering the production of proteins that P. aeruginosa needs to build its cell walls, resulting in damage to the bacteria, which eventually kills them.
Danish: Det virker ved at gribe ind i produktionen af de proteiner, som P. aeruginosa har brug for til at bygge sine cellevægge, og dét beskadiger bakterierne tilstrækkeligt til, at de til sidst dør.
English: In addition, it takes less time to inhale Vantobra than other tobramycin nebulisers and the time it takes is comparable to the time it takes to inhale the dry powder.
Danish: Desuden er det mindre tidskrævende at inhalere Vantobra end andre tobramycin-nebulisatorer, og den tid, det tager, er sammenlignelig med den tid, det tager at inhalere tørpulveret.
English: If the patient is also receiving other inhaled treatments or chest physiotherapy, it is recommended that Vantobra is used last.
Danish: Hvis patienten modtager enten andre lægemidler til inhalering eller respirationsfysioterapi, anbefales det, at Vantobra anvendes til sidst.
English: What is Vantobra and what is it used for?
Danish: Hvad er Vantobra, og hvad anvendes det til?
English: Why is Vantobra authorised in the EU?
Danish: Hvorfor blev Vantobra godkendt i EU?
English: P. aeruginosa is a frequent cause of infections in cystic fibrosis patients.
Danish: P. aeruginosa er en hyppig årsag til infektioner hos patienter med cystisk fibrose.
English: In addition, a ‘bioequivalence' study in 58 patients with cystic fibrosis aged 6 years and above determined whether Vantobra produces similar levels of the active substance in the body as the reference medicine, Tobi.
Danish: Desuden gennemførtes et studie af bioækvivalensen hos 58 patienter i alderen 6 år og opefter, der led af cystisk fibrose, for at bestemme om Vantobra frembringer samme indhold af det aktive stof i kroppen som referencelægemidlet Tobi.
English: 1 Previously known as Tobramycin PARI.
Danish: 1 Tidligere kaldet Tobramycin PARI
English: Cystic fibrosis is an inherited disease in which thick mucus builds up in the lungs that allows bacteria to grow more easily, causing infections.
Danish: Cystisk fibrose er en arvelig sygdom, hvor tyk slim ophobes i lungerne, hvilket gør det lettere for bakterier at formere sig, således at der opstår infektioner.
English: For these patients Vantobra, which is inhaled as a solution from a nebuliser, would be a useful alternative.
Danish: For disse patienter ville Vantobra, i form af en opløsning til nebulisator, være et brugbart alternativ.
English: What are the risks associated with Vantobra?
Danish: Hvilke risici er der forbundet med Vantobra?
English: The Agency noted that inhaled tobramycin was the ‘gold standard' for treating P. aeruginosa infection in patients with cystic fibrosis and that some patients cannot use the dry powder form because of unacceptable side effects.
Danish: Agenturet bemærkede, at inhaleret tobramycin var den gyldne standard for behandling af P. aeruginosa-infektioner hos patienter med cystisk fibrose, og at nogle patienter ikke kan anvende tørpulveret på grund af uacceptable bivirkninger.
English: Vantobra is an antibiotic used for treating long-term lung infection caused by the bacteria Pseudomonas aeruginosa in patients aged six years and older who have cystic fibrosis.
Danish: Vantobra er et antibiotikum til behandling af langvarig lungeinfektion forårsaget af bakterien Pseudomonas aeruginosa hos patienter i alderen seks år og opefter, som har cystisk fibrose.
English: Tobramycin has been used for several years to treat P. aeruginosa infection in patients with cystic fibrosis and the applicant submitted data from the literature to support the use of Vantobra.
Danish: Tobramycin er blevet anvendt i flere år til at behandle P. aeruginosa-infektioner hos patienter med cystisk fibrose, og ansøgeren fremlagde data fra faglitteraturen til underbygning af anvendelsen af Vantobra.
English: Side effects with Vantobra are not common.
Danish: Bivirkninger ved Vantobra optræder ikke hyppigt.
English: Vantobra is inhaled using a device called Tolero nebuliser, which converts the solution in the ampoule into a fine mist.
Danish: Vantobra inhaleres med Tolero-nebulisatorsystemet, der omdanner opløsningen i ampullerne til en fin tåge.
English: How is Vantobra used?
Danish: Hvordan anvendes Vantobra?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vantobra have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Vantobra.
English: Vantobra is available as a nebuliser solution in single-dose ‘ampoules'.
Danish: Vantobra fås som opløsning til nebulisator i enkeltdosisbeholdere (ampuller).
English: What benefits of Vantobra have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Vantobra?
English: How does Vantobra work?
Danish: Hvordan virker Vantobra?
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration and marketing authorisation holders in the member states
Danish: Bilag I Liste over lægemidlets navne, lægemiddelformer, styrker, indgivelsesvej samt indehavere af markedsføringstilladelse i medlemsstaterne
English: Promixin nasal use
Danish: Promixin nasal anvendelse
English: Colixin 1 milijun IU prašak za otopinu za injekciju powder for solution for injection
Danish: Colixin 1 milijun IU prašak za otopinu za injekciju
English: COLIMYCINE 1.000.000 U.I., poudre et solvant pour solution injectable powder and solvent for solution for injection
Danish: COLIMYCINE 1.000.000 U.I., poudre et solvant pour solution injectable
English: ColiFin 2 Mio.
Danish: ColiFin 2 Mio. I.E.
English: COLIMYCINE 1 MUI, poudre et solvant pour inhalation par nébuliseur powder and solvent for nebuliser solution
Danish: COLIMYCINE 1 MUI, poudre et solvant pour inhalation par nébuliseur
English: Forest Pharma B.V. Newtonlaan 115
Danish: Forest Pharma B.V.
English: Colistimethate sodium 1 million international units powder for solution for injection or infusion powder for solution for injection/infusion
Danish: Colistimethate sodium 1 million international units powder for solution for injection or infusion
English: Colistimetato de sodio GES 1 MUI polvo para solución inyectable/para inhalación por nebulizador powder for solution for injection, powder for nebuliser solution
Danish: Colistimetato de sodio GES 1 MUI polvo para solución inyectable/para inhalación por nebulizador
English: Colixin 1 MUI polvo para solución inyectable o para solución para inhalación por nebulizador powder for solution for injection, powder for nebuliser solution
Danish: Colixin 1 MUI polvo para solución inyectable o para solución para inhalación por nebulizador
English: Colomycin Injection 2 million international units powder for soln for inj, infusion or inhalation powder for solution for injection
Danish: Colomycin Injection 2 million international units powder for soln for inj, infusion or inhalation
English: powder for solution for injection/infusion/ inhalation
Danish: Powder for solution for injection, infusion or inhalation
English: ColiFin 1 Mio.
Danish: ColiFin 1 Mio. I.E.
English: Pulver zur Herstellung einer Lösung für einer Infusionslösung powder for solution for infusion
Danish: Pulver zur Herstellung einer Lösung für einer Infusionslösung
English: powder for solution for infusion
Danish: powder for solution for injection
English: Pulver zur Herstellung einer Injektions-/Infusionslösung powder for solution for injection/infusion
Danish: Pulver zur Herstellung einer Injektions-/Infusionslösung
English: Colistin ForestTrockenstechampullen mit Lösungsmittel powder and solvent for suspension for injection, nebuliser solution intramuscular use, intravenous use, inhalation use
Danish: 1000000 IE Pulver og solvens til injektionsvæske, suspension, inhalationsvæske til nebulisator, opløsning intramuskulær anvendelse, intravenøs anvendelse, til inhalation
English: Colomycin Injection 1million International Units powder for solution for injection, infusion or inhalation powder for solution for injection/infusion/ inhalation
Danish: Colomycin Injection 1million International Units powder for solution for injection, infusion or inhalation
English: Colistimethat-Natrium Infectopharm I.E. Pulver zur Herstellung einer Injektionsoder Infusionslösung powder for solution for injection/infusion
Danish: Colistimethat-Natrium Infectopharm I.E.
English: powder for solution for injection, injection or inhalation intramuscular use, intravenous use, inhalation use
Danish: 1000000 IE pulver til injektionsvæske, infusionsvæske eller inhalationsvæske, opløsning intramuskulær anvendelse, intravenøs anvendelse, til inhalation
English: powder for solution for injection/infusion, powder for nebuliser solution
Danish: 2000000 IE pulver til injektionsvæske/infusion svæske, opløsning, pulver til opløsning til nebulisator
English: Colomycin Injection 1 million international units powder for soln for inj, infusion or inhalation powder for solution for injection, infusion or inhalation intramuscular use, intravenous use, inhalation use
Danish: Colomycin Injection 1 million international units powder for soln for inj, infusion or inhalation
English: Colistin Xellia powder for solution for injection/infusion
Danish: Colistimethatnatrium "Xellia" 1000000 IE pulver til injektions/infusionsvæske, opløsning
English: Promixin 1 million international units (IU) powder for solution for infusion powder for solution for injection intramuscular use, intravenous use
Danish: Promixin 1 million international units (IU) powder for solution for infusion
English: It is transmitted by mosquitoes and is most common in Asia, particularly in rural areas.
Danish: Den overføres af myg og er mest almindelig i Asien, især i landdistrikter.
English: • The third main study involved 1,869 children aged between 2 months and 18 years.
Danish: • Det tredje hovedstudie omfattede 1.869 børn mellem to måneder og 18 år.
English: Vaccination must be postponed in people with recent severe fever.
Danish: Vaccinationen skal udsættes hos personer, der for nyligt har haft høj feber.
English: Ixiaro received a marketing authorisation valid throughout the EU on 31 March 2009.
Danish: Ixiaro fik en markedsføringstilladelse med gyldighed i hele EU den 31. marts 2009.
English: They also showed that a booster dose might be needed to maintain high levels of protection, which may be necessary for people at high risk of exposure to the virus.
Danish: De viste også, at en boosterdosis kan være påkrævet for at opretholde høje beskyttelsesniveauer, hvilket kan være nødvendigt for personer med høj risiko for at blive udsat for virusset.
English: The antibodies will help to protect against the disease.
Danish: Antistofferne medvirker til at beskytte mod sygdommen.
English: The second dose should be given at least one week before potential exposure to the virus.
Danish: Den anden dosis bør gives mindst én uge inden en potentiel eksponering for virusset.
English: Further information on Ixiaro can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Ixiaro.
Danish: Yderligere information om Ixiaro findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Ixiaro.
English: This was compared with 94% of the people receiving the comparator vaccine (347 out of 370).
Danish: Til sammenligning var procentandelen 94 % for de personer, som fik sammenligningsvaccinen (347 ud af 370).
English: Before vaccination, most of the people in the study had no protective levels of antibodies against the virus.
Danish: Inden vaccinationen havde de fleste af personerne i studiet ingen beskyttende antistofmængder mod virusset.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend against a disease.
Danish: Vacciner virker ved at "lære" immunsystemet (kroppens naturlige forsvar), hvordan det skal forsvare sig mod en sygdom.
English: Long-term antibody levels were similar with both schedules.
Danish: De langsigtede antistofniveauer påvist i begge forløb var identiske.
English: The 7-day accelerated vaccination course did not produce lower protection than the standard 4-week vaccination course.
Danish: Det syvdages accelererede vaccinationsforløb gav ikke ringere beskyttelse end standardvaccinationsforløbet på fire uger.
English: In adults, the second dose can be given up to 11 months after the first.
Danish: Hos voksne kan den anden dosis gives op til 11 måneder efter den første.
English: Japanese encephalitis can be fatal or lead to long-term disability.
Danish: Japansk encephalitis kan være dødelig eller føre til langvarig invaliditet.
English: Other information about Ixiaro
Danish: Andre oplysninger om Ixiaro
English: As for all medicines, data on the use of Ixiaro are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Ixiaro løbende overvåget.
English: When a person is given the vaccine, the immune system identifies the inactivated virus as ‘foreign' and makes antibodies against it.
Danish: Når en person vaccineres, opfatter immunsystemet det inaktiverede virus som "fremmed" og danner antistoffer mod det.
English: This means that the virus is fixed onto aluminium compounds, to stimulate a better response.
Danish: Dette betyder, at virusset er bundet til aluminiumholdige forbindelser, hvorved reaktionen forstærkes.
English: For more information about using Ixiaro, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Ixiaro, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Side effects reported with Ixiaro are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Ixiaro vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: The virus in Ixiaro is grown in mammal cells (‘Vero cells') under laboratory conditions.
Danish: Virusset i Ixiaro er dyrket i pattedyrceller ("Vero-celler") under laboratorieforhold.
English: The European Medicines Agency decided that Ixiaro's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Ixiaro opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Ixiaro?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ixiaro?
English: The Agency noted that the production of the only other vaccine for protection against Japanese encephalitis that was in use outside Asia had been discontinued.
Danish: Agenturet bemærkede, at fremstillingen af den eneste anden vaccine mod japansk encephalitis i brug uden for Asien var ophørt.
English: Four weeks after the final injection, 96% of these people who received both doses of Ixiaro had developed protective levels of antibodies (352 out of 365).
Danish: Fire uger efter den sidste injektion havde 96 % af de personer, som havde fået begge doser af Ixiaro, udviklet beskyttende antistofmængder (352 ud af 365).
English: Vaccination with Ixiaro should be considered for people who are at risk of exposure to the Japanese encephalitis virus through travel or work.
Danish: Vaccination med Ixiaro bør overvejes af personer, som har risiko for at blive udsat for japansk encephalitisvirus via rejser eller arbejde.
English: Ixiaro (Japanese encephalitis vaccine (inactivated, adsorbed))
Danish: Ixiaro (Japansk encephalitisvaccine (inaktiveret, adsorberet))
English: Adults from 18 to 65 years can also receive a rapid vaccination course, where the second dose is given seven days after the first dose.
Danish: Voksne mellem 18 og 65 år kan også gennemgå et hurtigt vaccinationsforløb, hvor den anden dosis gives syv dage efter den første.
English: These additional studies showed that protection against Japanese encephalitis virus lasted for at least 2 to 3 years in most people vaccinated with Ixiaro.
Danish: Disse supplerende studier viste, at beskyttelsen mod japansk encephalitisvirus varede mindst to-tre år hos størsteparten af de personer, der var vaccineret med Ixiaro.
English: In addition, the company presented the results of studies looking at the level of protection in adults and in children for up to 3 years after vaccination with Ixiaro, and at the response to booster doses.
Danish: Derudover fremlagde virksomheden resultaterne af studier vedrørende beskyttelsesniveauet hos voksne og børn i op til tre år efter vaccination med Ixiaro og på reaktionen på boosterdoser.
English: • The second main study in 660 adults compared a rapid vaccination course (2 doses given 7 days apart) with the standard vaccination course (2 doses given 4 weeks apart).
Danish: • Det andet studie omfattende 660 voksne, og der blev her foretaget en sammenligning af et hurtigt vaccinationsforløb (to doser med syv dages mellemrum) med standardvaccinationsforløbet (to doser med fire ugers mellemrum).
English: It is recommended that individuals who receive the first dose of Ixiaro should receive both doses.
Danish: Det anbefales, at personer, som får den første dosis af Ixiaro, modtager begge doser.
English: Ixiaro can only be obtained with a prescription.
Danish: Ixiaro udleveres kun efter recept.
English: Children and adolescents may also receive a booster dose one to two years after the initial vaccination.
Danish: Børn og unge kan også modtage en boosterdosis ét eller to år efter den første vaccination.
English: An overview of Ixiaro and why it is authorised in the EU
Danish: En oversigt over Ixiaro, og hvorfor det er godkendt i EU
English: In future, the immune system will be able to produce antibodies quickly and in large numbers when it is exposed to Japanese encephalitis virus again.
Danish: Efterfølgende vil immunsystemet være i stand til hurtigere og i store mængder at danne antistoffer, når det udsættes for japansk encephalitisvirus igen.
English: The most common side effects with Ixiaro in adults (which may affect more than 1 in 10 people) are headache, myalgia (muscle pain), pain and tenderness at the injection site and tiredness.
Danish: De hyppigste bivirkninger ved Ixiaro hos voksne (som optræder hos mere end én ud af 10 patienter) er hovedpine, myalgi (muskelsmerter), smerter og ømhed på injektionsstedet og træthed.
English: On average, the levels of antibodies were over 2 times higher in the people receiving Ixiaro than in those receiving the comparator vaccine.
Danish: Gennemsnitligt var antistofmængden mere end to gange højere hos de personer, der fik Ixiaro, end hos dem, som fik sammenligningsvaccinen.
English: Adults from 18-65 years who are likely to be exposed to the Japanese encephalitis virus again or who are at continuous risk of the disease should receive a booster dose of Ixiaro one to two years later and a second booster dose 10 years after the first booster.
Danish: Voksne mellem 18-65 år, der forventes at blive udsat for japansk encephalitisvirus igen, eller som konstant har risiko for at få sygdommen, bør modtage en boosterdosis af Ixiaro et eller to år senere og en anden boosterdosis 10 år efter den første booster.
English: Anyone who has an allergic reaction after the first dose of Ixiaro should not receive the second dose.
Danish: Personer, som oplever en allergisk reaktion efter den første dosis af Ixiaro, bør ikke få den anden dosis.
English: Ixiaro contains small amounts of the virus that causes Japanese encephalitis, which has been inactivated (killed) so that it cannot cause the disease.
Danish: Ixiaro indeholder små mængder af det virus, der forårsager japansk encephalitis, og som er blevet inaktiveret (dræbt), så det ikke forårsager sygdommen.
English: Why is Ixiaro authorised in the EU?
Danish: Hvorfor blev Ixiaro godkendt i EU?
English: Ixiaro is given by injection into a muscle, preferably into the shoulder muscle, or into the thigh muscle in young children.
Danish: Ixiaro gives som en injektion i en muskel, fortrinsvis i skuldermusklen, eller i lårmusklen hos små børn.
English: Ixiaro must not be used in people who are hypersensitive (allergic) to any residual substances in the vaccine such as protamine sulphate.
Danish: Ixiaro må ikke anvendes hos personer, som er overfølsomme (allergiske) over for eventuelle reststoffer i vaccinen, såsom protaminsulfat.
English: A booster dose should also be considered for adults aged above 65 years before any further exposure to the Japanese encephalitis virus.
Danish: Det bør også overvejes at give voksne over 65 år en boosterdosis før yderligere udsættelse for japansk encephalitisvirus.
English: What is Ixiaro and what is it used for?
Danish: Hvad er Ixiaro, og hvad anvendes det til?
English: 99% to 100% of children who received both doses of Ixiaro had developed protective levels of antibodies against the Japanese encephalitis virus 4 weeks after the final injection.
Danish: 99 % til 100 % af de børn, der fik begge doser Ixiaro, havde udviklet beskyttende antistofmængder mod japansk encephalitisvirus fire uger efter den sidste injektion.
English: Ixiaro (given as 2 doses 4 weeks apart) was as effective as the comparator vaccine at triggering the production of antibodies against the Japanese encephalitis virus.
Danish: Ixiaro (givet som to doser med fire ugers mellemrum) var lige så effektivt som sammenligningsvaccinen til at udløse produktionen af antistoffer mod japansk encephalitisvirus.
English: • The first study involved 867 healthy adults and compared Ixiaro with another vaccine for Japanese encephalitis containing viruses grown in mouse brains.
Danish: • Det første studie omfattede 867 raske voksne, og Ixiaro blev her sammenlignet med en anden vaccine mod japansk encephalitis, som indeholdt virus dyrket i musehjerner.
English: Ixiaro can be injected under the skin in people who have a bleeding disorder such as low blood platelet counts or haemophilia.
Danish: Ixiaro kan injiceres under huden på personer, som har en blødningsforstyrrelse, som f.eks. lavt blodpladetal eller hæmofili.
English: What are the risks associated with Ixiaro?
Danish: Hvilke risici er der forbundet med Ixiaro?
English: In adults, including those aged above 65 years, and children aged 3 years and older, a full dose of Ixiaro (0.5 ml) should be given, and an additional 0.5 ml dose should be given four weeks later.
Danish: Hos voksne, herunder personer over 65 år, og børn på tre år og derover bør der gives en fuld dosis af Ixiaro (0,5 ml) efterfulgt af en yderligere dosis på 0,5 ml fire uger senere.