FrancophonIA/ELRC3.0 huggingface dataset:
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented: The Member States shall agree the details of a Patient Alert Card (PAC) with the MAH, who must provide this PAC directly to the pharmacy with each Ranexa shipment.
Danish: Medlemsstaterne skal aftale de nærmere detaljer vedrørende et alarmkort med indehaveren af markedsføringstilladelsen, som skal levere alarmkortet direkte til apoteket sammen med hver Ranexa-forsendelse.
English: • That prior to Ranexa treatment the patient should tell their doctor if they have any of the following:
Danish: • Patienten skal informere sin læge, før han/hun begynder at tage Ranexa, hvis en eller flere af følgende omstændigheder gør sig gældende:
English: • Is taking the herbal remedy St John's Wort
Danish: • Patienten tager plantelægemidlet prikbladet perikon
English: • To refer to the Ranexa package leaflet for more information.
Danish: • For yderligere oplysninger skal patienten læse indlægssedlen til Ranexa.
English: EU/1/15/1084/001 Portrazza
Danish: EU/1/15/1084/001
English: 50 ml (16 mg/ml) 1 vial
Danish: 50 ml (16 mg/ml) 1 hætteglas
English: Intravenous use Vial (glass)
Danish: Intravenøs brug Hætteglas (glas)
English: 800 mg Concentrate for solution for infusion
Danish: Portrazza 800 mg koncentrat til infusionsvæske, opløsning
English: The capsules must never be swallowed.
Danish: Kapslerne må aldrig synkes.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Bronchitol on 13 April 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Bronchitol den 13. april 2012.
English: FEV1 is the maximum volume of air a person can breathe out in one second.
Danish: FEV1 er den størst mulige mængde luft, som en person kan udånde på ét sekund.
English: This is a summary of the European public assessment report (EPAR) for Bronchitol.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Bronchitol.
English: The evening dose should be taken two to three hours before bedtime.
Danish: Aftendosis skal tages to-tre timer før sengetid.
English: The effects of Bronchitol were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Bronchitol blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: This means that it can promote osmosis (the flow of liquid across a membrane).
Danish: Det betyder at det fremmer osmose (væskestrømning gennem en membran).
English: In order to obtain further information on effectiveness and safety of Bronchitol in children and adolescents with cystic fibrosis the CHMP requested the company to carry out a study in this patient group.
Danish: For at skaffe mere viden om virkningen og sikkerheden af Bronchitol hos børn og unge med cystisk fibrose anmodede CHMP virksomheden om at udføre en undersøgelse hos denne patientgruppe.
English: Other information about Bronchitol
Danish: Andre oplysninger om Bronchitol
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Bronchitol.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Bronchitol.
English: For more information about treatment with Bronchitol, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Bronchitol, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Because the number of patients with cystic fibrosis is low, the disease is considered ‘rare', and Bronchitol was designated an ‘orphan medicine' (a medicine used in rare diseases) on 7 November
Danish: Da antallet af patienter med cystisk fibrose er lavt, betragtes sygdommen som “sjælden”, og Bronchitol blev udpeget som “lægemiddel til sjældne sygdomme” den 7. november 2005.
English: The most common side effect with Bronchitol (seen in more than 1 patient in 10) is cough.
Danish: Den almindeligste bivirkning ved brug af Bronchitol (som ses hos flere end 1 ud af 10 patienter) er hoste.
English: Bronchitol was tested in two main studies involving 642 patients between six and 56 years of age with mild or moderate cystic fibrosis.
Danish: Bronchitol blev undersøgt i to hovedundersøgelser med 642 patienter mellem 6 og 56 år med let til moderat cystisk fibrose.
English: The recommended dose is 400 mg (which requires the inhalation of the content of 10 capsules loaded individually into the inhaler) twice a day in the morning and in the evening.
Danish: Den anbefalede dosis er 400 mg (svarende til at man indånder indholdet af ti kapsler, der enkeltvis er anbragt i inhalatoren) to gange dagligt: morgen og aften.
English: Some patients also received additional treatment with rhDNase (another treatment for cystic fibrosis).
Danish: Nogle patienter blev desuden behandlet med rhDNase (et andet middel, der anvendes ved cystisk fibrose).
English: Patients overall showed an improvement of approximately 2-3% in FEV1 adjusted for age, height and sex when compared with placebo over 26 weeks of treatment with Bronchitol.
Danish: Patienterne fik en samlet forbedring på ca. 2-3 % i FEV1, korrigeret for alder, højde og køn, i forhold til placebo i løbet af 26 ugers behandling med Bronchitol.
English: This leads to problems with the digestion and absorption of food, resulting in poor growth, and long-term infection and inflammation of the lungs because of excess mucus not being cleared away.
Danish: Dette medfører problemer med fordøjelsen og optagelsen af næringsstoffer fra føden, hvilket fører til dårlig vækst og langvarig inflammation af lungerne, fordi overskydende slim ikke skaffes af vejen.
English: Regarding the safety of Bronchitol, the CHMP considered that sufficient measures have been proposed by the company to reduce the risks of bronchospasm and haemoptysis.
Danish: Hvad angår sikkerheden af Bronchitol, fandt CHMP, at virksomheden har foreslået tilstrækkelige foranstaltninger til at nedsætte risikoen for bronkospasme og blodopspyt.
English: The company that makes Bronchitol must ensure that all healthcare professionals expected to prescribe the medicine are provided with important safety information including information on the risk of narrowing of the airways in the lungs and the coughing of blood and how to manage this risk.
Danish: Den virksomhed, der fremstiller Bronchitol, skal sikre, at alle sundhedspersoner, der forventes at ordinere lægemidlet, får vigtig sikkerhedsinformation om risikoen for forsnævring af luftvejene i lungerne og blodspytning og om, hvad de skal gøre over for denne risiko.
English: Bronchitol is a medicine that contains the active substance mannitol.
Danish: Bronchitol er et lægemiddel, der indeholder det aktive stof mannitol.
English: The full EPAR for Bronchitol can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige europæiske offentlige vurderingsrapport for Bronchitol findes på agenturets websted under: : ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Bronchitol must not be used in people who are hypersensitive (allergic) to mannitol.
Danish: Bronchitol må ikke anvendes hos personer, der er overfølsomme (allergiske) over for mannitol.
English: It is available as capsules (40 mg) containing a dry powder for inhalation using an inhaler device.
Danish: Det leveres som kapsler (40 mg), der indeholder et inhalationspulver, der inhaleres (indåndes) ved hjælp af en inhalator.
English: Bronchitol is used for the treatment of cystic fibrosis in adults in addition to best standard of care.
Danish: Bronchitol anvendes til behandling af cystisk fibrose hos voksne som tillæg til bedste standardbehandling.
English: The exact way in which Bronchitol works in cystic fibrosis is not known.
Danish: Det vides ikke nøjagtigt, hvordan Bronchitol virker ved cystisk fibrose.
English: The most serious side effect with Bronchitol is bronchospasm (narrowing of the airways of the lung) during the initiation dose assessment and haemoptysis (coughing of blood) during treatment with Bronchitol.
Danish: Den alvorligste bivirkning med Bronchitol er bronkospasme (forsnævring af luftvejene i lungerne) under bestemmelsen af begyndelsesdosis samt blodspytning under behandlingen med Bronchitol.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Bronchitol can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Bronchitol findes på EMA's websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
English: What measures are being taken to ensure the safe use of Bronchitol?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Bronchitol?
English: The active substance in Bronchitol, mannitol, is a naturally occurring polyol (a sugar alcohol) that is widely used as an osmotic agent.
Danish: Det aktive stof i Bronchitol, mannitol, er en naturligt forekommende sukkeralkohol, der har udbredt anvendelse som osmotisk middel.
English: The Committee took the view that although the improvement in FEV1 shown by the studies was small Bronchitol may be of benefit in patients with cystic fibrosis if used in addition to best standard of care.
Danish: Udvalget indtog den holdning, at skønt undersøgelserne kun havde vist en lille bedring i FEV1, kan Bronchitol være til fordel for patienter med cystisk fibrose, hvis det anvendes som tillæg til bedste standardbehandling.
English: The CHMP therefore concluded that the benefits of Bronchitol in addition to best standard of care outweigh its risks for adult patients with cystic fibrosis and recommended that it be granted marketing authorisation.
Danish: CHMP konkluderede derfor, at fordelene ved Bronchitol overstiger risiciene som tillæg til bedste standardbehandling af voksne patienter med cystisk fibrose, og anbefalede udstedelse af markedsføringstilladelse.
English: In cystic fibrosis these fluids become thick and viscous, blocking the airways and the flow of digestive juices.
Danish: Ved cystisk fibrose bliver disse væsker tykke og seje, så de blokerer for luftvejene og passagen af fordøjelsesvæsker.
English: Patients who show bronchial hyperresponsiveness must not be treated with Bronchitol.
Danish: Patienter, der viser sig at have hyperreaktivitet af bronkierne, må ikke få Bronchitol.
English: Why has Bronchitol been approved?
Danish: Hvorfor blev Bronchitol godkendt?
English: Bronchitol is inhaled using the inhaler device provided.
Danish: Bronchitol inhaleres ved hjælp af den medfølgende inhalator.
English: Cystic fibrosis is an inherited disease that affects the cells in the lungs and the glands in the gut and pancreas that secrete fluids such as mucus and digestive juices.
Danish: Cystisk fibrose er en arvelig sygdom, der angriber cellerne i lungerne og de kirtelceller i tarmen og bugspytkirtlen, der udskiller slim og fordøjelsesvæsker.
English: For the full list of all side effects reported with Bronchitol, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger med Bronchitol fremgår af indlægssedlen.
English: In both studies the patients received either 400 mg of inhaled Bronchitol twice daily or 50 mg of inhaled Bronchitol twice daily (which was considered ineffective and hence intended as placebo (dummy treatment)).
Danish: I begge undersøgelser fik patienterne enten 400 mg inhaleret Bronchitol to gange dagligt eller 50 mg inhaleret Bronchitol to gange dagligt.
English: What is the risk associated with Bronchitol?
Danish: Hvilken risiko er der forbundet med Bronchitol?
English: Bronchitol must also not be used in patients with bronchial hyperresponsiveness.
Danish: Bronchitol må ikke anvendes hos patienter med hyperreaktivitet af bronkierne.
English: For more information on how to use Bronchitol, see the instructions in the package leaflet.
Danish: Yderligere oplysninger om brugen af Bronchitol er givet i anvisningerne i indlægssedlen.
English: The main measure of effectiveness was based on the improvement in patients' forced expiratory volume in one second (FEV1) adjusted for the patients age, height and sex, measured over 26 weeks in both studies.
Danish: Behandlingens virkning blev hovedsagelig bedømt på bedringen i patienternes FEV1, dvs. forceret udåndingsvolumen i første sekund, korrigeret for alder, højde og køn.
English: What is Bronchitol?
Danish: Hvad er Bronchitol?
English: This first dose of 400 mg Bronchitol should only be given under the supervision of a qualified healthcare professional in a setting where the patient's breathing can be properly monitored and facilities for resuscitation are available.
Danish: Den første dosis på 400 mg af Bronchitol må kun gives under opsyn af uddannet medicinsk personale.
English: How has Bronchitol been studied?
Danish: Hvordan blev Bronchitol undersøgt?
English: What is Bronchitol used for?
Danish: Hvad anvendes Bronchitol til?
English: What benefit has Bronchitol shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Bronchitol?
English: After being inhaled, Bronchitol is believed to cause the inflow of fluid into the airway secretions in the lungs, making them less viscous and therefore easier to be cleared away.
Danish: Man mener, at når Bronchitol indåndes, medfører det væsketilstrømning til sekretet i lungerne.
English: How is Bronchitol used?
Danish: Hvordan anvendes Bronchitol?
English: How does Bronchitol work?
Danish: Hvordan virker Bronchitol?
English: Before initiating treatment with Bronchitol, patients need to undergo an initiation dose assessment during which they are challenged with an increasing dose of Bronchitol up to 400 mg in total to detect bronchial hyperresponsiveness (a state in which the airways of the lungs narrow easily).
Danish: De bliver herunder belastet med en stigende dosis af Bronchitol på op til 400 mg.
English: The vaccine has been authorised under ‘exceptional circumstances'.
Danish: Vaccinen er blevet godkendt under ”særlige omstændigheder”.
English: This will help to protect against the disease caused by the virus.
Danish: Dette er med til at beskytte mod den sygdom, som forårsages af virusset.
English: The full EPAR for Pumarix can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Pumarix findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Dosing recommendations are only available for adults.
Danish: De anbefalede doseringer er kun tilgængelige for voksne.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pumarix to GlaxoSmithKline Biologicals s.a. on 4 March 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Pumarix til GlaxoSmithKline Biologicals s.a. den 4. marts 2011.
English: Adults should be given a dose of 0.5 ml followed by a second dose after an interval of at least three weeks.
Danish: Voksne skal have en dosis på 0,5 ml efterfulgt af en yderligere dosis efter en periode på mindst tre uger.
English: This is a summary of the European public assessment report (EPAR) for Pumarix.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Pumarix.
English: The virus has first been inactivated so that it does not cause any disease.
Danish: Virusset er først blevet inaktiveret, så det ikke er sygdomsfremkaldende.
English: However, it may be appropriate to give the vaccine to these patients during a pandemic, as long as facilities for resuscitation are available.
Danish: Det kan dog være hensigtsmæssigt at vaccinere sådanne patienter under en pandemi, forudsat at der er genoplivningsudstyr til rådighed.
English: The effects of Pumarix were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Pumarix blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: It contains parts of influenza (flu) viruses that have been inactivated (killed).
Danish: Den indeholder dele af influenzavira, som er blevet inaktiveret (dræbt).
English: Instead, they can prepare a vaccine that contains a strain of flu virus specifically chosen because very few people have been exposed to it, and to which very few people are immune.
Danish: I stedet kan de fremstille en vaccine, som indeholder en influenzavirusstamme, der specifikt udvælges, fordi meget få personer har været udsat for den, og fordi meget få er immune over for den.
English: Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.
Danish: Hvert år gennemgår Det Europæiske Lægemiddelagentur alle nye oplysninger, der måtte foreligge, og
English: In the second main study, 4,560 adults were given either Pumarix or placebo (a dummy vaccine).
Danish: I den anden hovedundersøgelse fik 4 560 voksne enten Pumarix eller placebo (en virkningsløs vaccine).
English: Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Danish: pandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret)
English: This vaccine contains small amounts of haemagglutinins (proteins from the surface) of a virus called H5N1.
Danish: Denne vaccine indeholder små mængder af hæmagglutininer (overfladeproteiner) fra en virus kaldet H5N1.
English: The vaccine is given by injection into muscle, preferably into shoulder or thigh muscle.
Danish: Vaccinen gives ved injektion i en muskel, helst skulder- eller lårmusklen.
English: What information is still awaited for Pumarix?
Danish: Hvilke oplysninger afventes der stadig for Pumarix?
English: A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world.
Danish: En influenzapandemi forekommer, når der opstår en ny stamme af en influenzavirus, der let spredes fra en person til en anden, fordi mennesker ikke har nogen immunitet over for den. En pandemi kan berøre de fleste lande og regioner i verden.
English: The emulsion contains the ‘adjuvant' to enhance the immune response.
Danish: Emulsionen indeholder adjuvanset til forbedring af immunresponsen.
English: When the company that makes the vaccine includes in it the flu strain responsible for a pandemic, it will collect information on the safety and effectiveness of the final pandemic vaccine, and submit this to the CHMP for evaluation.
Danish: Når virksomheden, som fremstiller vaccinen, inkluderer den influenzastamme, som er ansvarlig for pandemien, i vaccinen, skal den indsamle oplysninger om sikkerhed og virkning af den endelige pandemivaccine og forelægge disse for CHMP til evaluering.
English: Before use, the vaccine will be made up by mixing together a suspension that contains the virus particles with an emulsion.
Danish: Inden brug skal vaccinen gøres klar ved at blande en suspension, der indeholder viruspartiklerne, med en emulsion.
English: People who have previously been vaccinated with a vaccine that contains the same adjuvant (a substance added to enhance the immune response) and a flu strain similar to the one causing the pandemic will only need one single dose.
Danish: Personer, der tidligere har modtaget en vaccine indeholdende samme adjuvans (et tilsætningsstof, der øger immunresponsen) og en influenzastamme svarende til den influenzastamme, der forårsager pandemien, behøver kun en enkelt dosis.
English: One main study involving 680 adults compared Pumarix given as two doses three weeks apart with Pandemrix H5N1 (another pandemic influenza vaccine) and also compared Pumarix given with and without an adjuvant.
Danish: I en hovedundersøgelse af 680 voksne sammenlignede man Pumarix givet som to doser med tre ugers mellem med Pandemrix H5N1 (en anden pandemisk influenzavaccine), og man sammenlignede desuden virkningen af Pumarix givet med og uden et adjuvans.
English: Pumarix should not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at trace levels in the vaccine, such as egg or chicken protein, ovalbumin (a protein in egg white), formaldehyde and sodium deoxycholate.
Danish: Pumarix må ikke gives til patienter, der har haft en anafylaktisk reaktion (en alvorlig allergisk reaktion) på nogen af vaccinens indholdsstoffer eller på nogen af de sporstoffer, den indeholder, f.eks. æggeeller kyllingeprotein, ovalbumin (et protein i æggehvide), formaldehyd og natriumdeoxycholat.
English: The study also showed that Pumarix triggered the production of more antibodies when given with an adjuvant than when given without.
Danish: Undersøgelsen viste desuden, at Pumarix udløste dannelse af flere antistoffer, når det blev givet med et adjuvans, end når det blev givet uden.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Pumarix.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om
English: Pumarix is a vaccine that is given by injection.
Danish: Pumarix er en vaccine, der gives ved injektion.
English: It should only be used once a flu pandemic has been officially declared by the World Health Organization (WHO) or European Union (EU).
Danish: Det er en vaccine, der kun må bruges, når Verdenssundhedsorganisationen eller Den Europæiske Union (EU) officielt har erklæret, at der er udbrudt en pandemi.
English: Pumarix is a vaccine to protect against ‘pandemic' flu.
Danish: Pumarix er en vaccine til beskyttelse mod ”pandemisk” influenza.
English: The second study showed that Pumarix was able to trigger the production of antibodies to a level high enough to meet CHMP criteria.
Danish: Den anden undersøgelse viste, at Pumarix kunne udløse dannelse af antistoffer i så høj en grad, at det overholder CHMP's kriterier.
English: Why has Pumarix been approved?
Danish: Hvorfor blev Pumarix godkendt?
English: The most common side effects with Pumarix (seen in more than 1 patient in 10) are headache, joint pain, muscle ache, pain at injection site and fatigue (tiredness).
Danish: De hyppigste bivirkninger ved Pumarix (som optræder hos flere end 1 ud af 10 patienter) er hovedpine, ledsmerter, muskelsmerter, smerte på injektionsstedet og træthed.
English: The CHMP decided that the vaccine's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved vaccinen opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Pumarix.
English: This is a special type of vaccine that can be developed to help with the management of a future pandemic.
Danish: En modelvaccine er en særlig vaccinetype, der kan udvikles for at kontrollere en fremtidig pandemi.
English: For more information about treatment with Pumarix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Pumarix, kan du læse indlægssedlen (også en del af denne EPAR) eller