FrancophonIA/ELRC3.0 huggingface dataset:
English: There were no effects on fertility in animal studies.
Danish: Í dýrarannsóknum komu engin áhrif á frjósemi fram.
English: Not applicable.
Danish: Á ekki við.
English: Musculoskeletal and connective tissue disorders
Danish: Tengsl lyfjahvarfa og lyfhrifa
English: Nervous system disorders
Danish: Sýking í efri öndunarvegi Mæði
English: Gastrointestinal disorders Nausea Vomiting
Danish: Lenging QT-bils og sleglasláttarglöp vegna blóðkalsíumlækkunar
English: General
Danish: Almennt
English: Anorexia Decreased appetite
Danish: Lystarleysi Minnkuð matarlyst
English: Fertility
Danish: Dreifing
English: • muscle spasms
Danish: c) Lýsing á völdum aukaverkunum
English: The recommended dose is two inhalations twice a day.
Danish: Den anbefalede dosis er to inhalationer to gange dagligt.
English: Riarify received a marketing authorisation valid throughout the EU on 23 April 2018.
Danish: Riarify fik en markedsføringstilladelse med gyldighed i hele EU den 23. april 2018.
English: This medicine is the same as Trimbow, which is already authorised in the EU.
Danish: Lægemidlet er identisk med Trimbow, som allerede er godkendt i EU.
English: The company that makes Trimbow has agreed that its scientific data can be used for Riarify (‘informed consent').
Danish: Virksomheden, som fremstiller Trimbow, har indvilget i, at dens videnskabelige oplysninger må anvendes for Riarify ("informeret samtykke").
English: As for all medicines, data on the use of Riarify is continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Riarify løbende overvåget.
English: Further information on Riarify can be found on the Agency's website: https://www.ema.europa.eu/en/medicines/human/EPAR/riarify-previously-chf-5993-chiesifarmaceutici-spa.
Danish: Yderligere information om Riarify findes på agenturets websted under: https://www.ema.europa.eu/en/medicines/human/EPAR/riarify-previously-chf-5993-chiesifarmaceutici-spa.
English: Other information about Riarify
Danish: Andre oplysninger om Riarify
English: For more information about using Riarify, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Riarify, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: An overview of Riarify and why it is authorised in the EU
Danish: En oversigt over Riarify, og hvorfor det er godkendt i EU
English: What measures are being taken to ensure the safe and effective use of Riarify?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Riarify?
English: The European Medicines Agency therefore decided that Riarify's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Riarify opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Side effects reported with Riarify are carefully evaluated and any necessary action taken to protect patients.
Danish: Indberettede bivirkninger ved Riarify vurderes omhyggeligt, og der tages de nødvendig forholdsregler for at beskytte patienterne.
English: It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system.
Danish: Det virker på samme måde som naturligt forekommende kortikosteroidhormoner og mindsker immunsystemets aktivitet.
English: Riarify (beclomethasone / formoterol / glycopyrronium bromide)
Danish: Riarify (beclometason/formoterol/glycopyrroniumbromid)
English: What is Riarify and what is it used for?
Danish: Hvad er Riarify, og hvad anvendes det til?
English: Why is Riarify authorised in the EU?
Danish: Hvorfor blev Riarify godkendt i EU?
English: Beclometasone belongs to anti-inflammatory medicines known as corticosteroids.
Danish: Beclometason hører ind under de antiinflammatoriske lægemidler, der kaldes kortikosteroider.
English: What are the risks associated with Riarify?
Danish: Hvilke risici er der forbundet med Riarify?
English: In this study, Riarify was as effective as tiotropium plus a combination of beclometasone and formoterol at reducing the number of exacerbations.
Danish: I dette studie var Riarify lige så effektivt som tiotropium plus en kombination af beclometason og formoterol til at reducere antallet af symptomforværringer.
English: No major safety concerns have been reported with Riarify, with side effects being manageable and similar to other COPD medicines.
Danish: Der er ikke indberettet væsentlige sikkerhedsproblemer ved Riarify, idet bivirkningerne er håndterbare og ligner bivirkningerne ved andre KOL-lægemidler.
English: It attaches to receptors (targets) known as beta-2 receptors in the muscles of the airways.
Danish: Det binder sig til receptorer (mål), de såkaldte beta2-receptorer i musklerne i luftvejene.
English: By comparison, the FEV1 increased by 1 and 145 ml before and after dosing in patients treated with a medicine containing only 2 of the active substances found in Riarify (beclometasone plus formoterol).
Danish: Til sammenligning steg FEV1 med 1 ml og 145 ml før og efter en dosis hos patienter, der blev behandlet med et lægemiddel, som indeholdt blot to af de aktive stoffer, der findes i Riarify (beclometason plus formoterol).
English: Beta-2 agonists and muscarinic receptor antagonists help to widen the airways; corticosteroids reduce inflammation in the airways and lungs.
Danish: Beta-2-agonister og muskarinreceptorantagonister bidrager til at udvide luftvejene, og kortikosteroider mindsker betændelse i luftvejene og lungerne.
English: Side effects with Riarify include oral candidiasis (a fungal infection of the mouth caused by a yeast called Candida), muscle spasms and dry mouth.
Danish: Bivirkningerne ved Riarify omfatter oral candidiasis (en svampeinfektion i munden forårsaget af gærsvampen Candida), muskelspasmer og mundtørhed.
English: Riarify is a medicine used in adults to relieve the symptoms of moderate to severe chronic obstructive pulmonary disease (COPD).
Danish: Riarify er et lægemiddel, der anvendes hos voksne til at lindre symptomerne på moderat til svær kronisk obstruktiv lungesygdom (KOL).
English: Glycopyrronium bromide is a long-acting muscarinic receptor antagonist.
Danish: Glycopyrroniumbromid er en langtidsvirkende muskarinreceptorantagonist.
English: Patients should be shown how to use the inhaler correctly by a doctor or another healthcare professional, who should also regularly check that the patient's inhalation technique is correct.
Danish: En læge eller en anden sundhedsperson skal vise patienterne, hvordan de anvender inhalatoren korrekt, og regelmæssigt tjekke, om de anvender den rigtige inhalationsteknik.
English: For the full list of side effects and restrictions with Riarify, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Riarify fremgår af indlægssedlen.
English: It opens the airways by blocking muscarinic receptors in muscle cells in the lungs.
Danish: Det udvider luftvejene ved at blokere muskarinreceptorer i muskelceller i lungerne.
English: Riarify contains the active substances beclometasone, formoterol and glycopyrronium bromide.
Danish: Riarify indeholder de aktive stoffer beclometason, formoterol og glycopyrroniumbromid.
English: In the first study lasting a year, after 26 weeks of treatment Riarify improved patients' FEV1 (the maximum volume of air a person can breathe out in one second) by 82 ml before a dose and 261 ml after a dose.
Danish: I det første studie, der varede et år, havde Riarify efter 26 ugers behandling forbedret patienternes FEV1 (den maksimale luftvolumen, der kan udåndes på ét sekund) med 82 ml før en dosis og 261 ml efter en dosis.
English: Riarify has been shown to be effective at relieving symptoms of COPD in three main studies involving over 5,500 patients whose symptoms were not controlled well enough either by combinations of two other COPD medicines or by a muscarinic receptor antagonist alone.
Danish: Riarify har vist sig effektivt til at lindre symptomerne på KOL i tre hovedstudier med over 5.500 patienter, hvis symptomer ikke var tilstrækkeligt reguleret med enten en kombination af to andre KOLlægemidler eller med en muskarinreceptorantagonist alene.
English: COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing.
Danish: KOL er en kronisk sygdom, hvor luftvejene og lungeblæresækkene bliver beskadigede eller blokerede, så vejrtrækningen vanskeliggøres.
English: Riarify is used for maintenance (continuing) treatment in patients whose disease is not adequately controlled despite treatment with a combination of two COPD medicines consisting of a long-acting beta-2 agonist plus either an inhaled corticosteroid or a long-acting muscarinic receptor antagonist.
Danish: Riarify anvendes til vedligeholdelsesbehandling (løbende behandling) af patienter, hvis sygdom ikke er tilstrækkeligt kontrolleret på trods af behandling med en kombination af to KOL-lægemidler bestående af en langtidsvirkende beta-2-agonist plus enten et inhaleret kortikosteroid eller en langtidsvirkende muskarinreceptorantagonist.
English: How is Riarify used?
Danish: Hvordan anvendes Riarify?
English: Riarify is effective at reducing the frequency of exacerbations and improving lung function of patients with COPD.
Danish: Riarify er effektivt til at nedsætte hyppigheden af symptomforværringer og forbedre lungefunktionen hos patienter med KOL.
English: Riarify is available as a liquid in a portable inhaler device.
Danish: Riarify fås som væske i en bærbar inhalator.
English: In the second study lasting a year, patients treated with Riarify had 20% fewer exacerbations (flareups of symptoms) per year than patients treated with tiotropium (a long-acting muscarinic receptor antagonist).
Danish: I det andet studie, der varede et år, havde patienter, der blev behandlet med Riarify, 20 % færre symptomforværringer om året end de patienter, der blev behandlet med tiotropium (en langtidsvirkende muskarinreceptorantagonist).
English: What benefits of Riarify have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Riarify?
English: This leads to a reduction in the release of substances involved in the inflammation process, such as histamine, thereby helping to keep the airways clear and allowing the patient to breathe more easily.
Danish: Dette mindsker frigivelsen af stoffer, der medvirker i inflammationsprocessen, såsom histamin, hvorved luftvejene bedre kan holdes frie, så patienten får lettere ved at trække vejret.
English: In the third study lasting a year, patients treated with Riarify had 15% fewer exacerbations a year than patients treated with a combination of indacaterol (a long-acting beta-2 agonist) and glycopyrronium bromide.
Danish: I det tredje studie, der varede et år, havde patienter, der blev behandlet med Trimbow, 15 % færre symptomforværringer om året end de patienter, der blev behandlet med en kombination af indacaterol (en langtidsvirkende beta-2-agonist) og glycopyrroniumbromid.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Riarify 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 Riarify.
English: The three active substances in Riarify work in different ways to reduce inflammation and keep the airways open, allowing the patient to breathe more easily.
Danish: De tre aktive stoffer i Riarify virker på forskellige måder ved at reducere betændelsestilstande og holde luftvejene åbne, hvilket gør det lettere for patienten at trække vejret.
English: Because these receptors help control the contraction of the airway muscles, blocking them causes the muscles to relax, helping to keep the airways open and allowing the patient to breathe more easily.
Danish: Da disse receptorer er med til at styre muskelsammentrækningen i luftvejene, vil blokeringen af dem få musklerne til at løsnes, hvorved luftvejene holdes åbne, og patienten får lettere ved at trække vejret.
English: By attaching to these receptors, it causes the muscles to relax, which keeps the airways open and helps with the patient's breathing.
Danish: Ved at binde sig til disse receptorer får det musklerne til at slappe af, så luftvejene holdes frie, og patienten lettere kan trække vejret.
English: These usually disappear without any treatment.
Danish: Disse forsvinder normalt uden behandling.
English: Contact with the skin, eyes or mouth should be avoided.
Danish: Kontakt med hud, øjne eller mund bør undgås.
English: Hands should be thoroughly washed immediately after use.
Danish: Hænderne bør vaskes grundigt umiddelbart efter brug.
English: Vectra Felis received a marketing authorisation valid throughout the EU on 6 June 2014.
Danish: Vectra Felis modtog en markedsføringstilladelse med gyldighed i hele EU den 6. juni 2014.
English: Used applicators should be disposed of immediately and not left within the sight or reach of children.
Danish: Brugte applikatorer bør bortskaffes med det samme og ikke efterlades inden for børns syns- eller rækkevidde.
English: Further information on Vectra Felis can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/vectra-felis.
Danish: Yderligere oplysninger om Vectra Felis findes på agenturets websted under: ema.europa.eu/medicines/veterinary/EPAR/vectra-felis.
English: People must not handle treated cats for at least eight hours after application of the veterinary medicine.
Danish: Personer må ikke komme i berøring med den behandlede kat i mindst otte timer efter påføringen af veterinærlægemidlet.
English: Treated cats should not be permitted to sleep with their owners, especially children, on the day of treatment.
Danish: På behandlingsdagen bør den behandlede kat ikke tillades at sove sammen med sin ejer, navnlig børn.
English: This means that it kills parasites that occur on the skin or in the fur of animals, such as fleas that feed on the animal's skin.
Danish: Det vil sige, at det dræber parasitter på dyrets hud eller pels, såsom lopper, der får næring fra dyrets hud.
English: Vectra Felis must not be used in cats or kittens weighing less than 0.6 kg.
Danish: Vectra Felis må ikke anvendes til katte eller killinger på under 0,6 kg.
English: Dinotefuran is an insecticide which kills insects by acting on receptors (targets) in their nervous system called nicotinic acetylcholine receptors.
Danish: Dinotefuran er et insekticid, der dræber insekter ved at påvirke receptorer (mål) i deres nervesystem kaldet nikotinerge acetylcholinreceptorer.
English: Vectra Felis was as effective as the comparator product and reduced flea counts by 91% over the 84 day study period.
Danish: Vectra Felis var lige så effektivt som sammenligningsproduktet og nedsatte antallet af lopper med 91 % i løbet af det 84 dage lange studie.
English: People with known hypersensitivity (allergy) to any of the ingredients should avoid contact with the product.
Danish: Personer med kendt overfølsomhed (allergi) over for et eller flere af indholdsstofferne bør undgå kontakt med produktet.
English: The effectiveness of Vectra Felis against fleas was investigated in a large number of laboratory studies and in one field study.
Danish: Virkningen af Vectra Felis mod lopper blev undersøgt i en lang række laboratorieundersøgelser og i ét feltstudie.
English: The need to re-treat cats and the time interval between treatments requires veterinary assessment.
Danish: Behovet for ombehandling af katten og tidsintervallet mellem behandlingerne bygger på dyrlægens skøn.
English: Other information about Vectra Felis
Danish: Andre oplysninger om Vectra Felis
English: It also prevents fleas from hatching and developing in the cat's environment.
Danish: Det forhindrer også lopper i at udklækkes og udvikles i kattens omgivelser.
English: If accidental exposure to the eyes occurs, the eyes should be rinsed with water with the eyelids open and for a sufficient length of time.
Danish: Ved utilsigtet øjenkontakt, bør øjnene skylles med vand, med øjenlågene åbne og i tilstrækkelig lang tid.
English: Vectra Felis acts as an ectoparasiticide.
Danish: Vectra Felis virker som et ektoparasiticid.
English: If skin or eye irritation persists, or if the veterinary medicine is accidentally swallowed, immediate medical advice should be sought and the package leaflet or label shown to the doctor.
Danish: Ved vedvarende hud- eller øjenirritation, eller hvis lægemidlet utilsigtet indtages, bør der straks søges lægehjælp, og indlægssedlen eller etiketten vises til lægen.
English: The European Medicines Agency decided that Vectra Felis' benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur besluttede, at fordelene ved Vectra Felis opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: The most common side effects with Vectra Felis (which may affect up to 1 in 1000 cats) are a slight scaling of the skin, temporary redness and itching or temporary hair loss at the application site.
Danish: De hyppigste bivirkninger ved Vectra Felis (som kan forekomme hos op til 1 ud af 1.000 katte) er let skældannelse, midlertidig rødme og kløe eller midlertidigt hårtab på applikationsstedet.
English: In case of accidental spillage onto skin, the area should be washed off immediately with soap and water.
Danish: Ved utilsigtet hudkontakt bør området straks vaskes med sæbe og vand.
English: An overview of Vectra Felis and why it is authorised in the EU
Danish: Oversigt over Vectra Felis, og hvorfor det er godkendt i EU
English: Vectra Felis is a veterinary medicine used to treat and prevent flea infestations in cats.
Danish: Vectra Felis er et lægemiddel til dyr, som anvendes til behandling og forebyggelse af loppeangreb hos katte.
English: Vectra Felis is available as a spot-on solution in an applicator and can be obtained without a prescription.
Danish: Vectra Felis findes som spot-on opløsning i en applikator og udleveres uden recept.
English: After a single treatment, Vectra Felis prevents fleas for one month and blocks the flea life cycle so preventing infestation in the cat's environment for three months.
Danish: Efter én behandling forhindrer Vectra Felis loppeforekomster i en måned og blokerer loppens livscyklus, hvorved angreb i kattens omgivelser forebygges i tre måneder.
English: The content of one full Vectra Felis applicator is applied directly to the cat's skin, after parting its fur, at the base of the cat's head.
Danish: Indholdet af en fuld applikator med Vectra Felis påføres direkte på huden nederst på kattens hoved, efter at pelsen er delt.
English: What is Vectra Felis and what is it used for?
Danish: Hvad er Vectra Felis, og hvad anvendes det til?
English: Why is Vectra Felis authorised in the EU?
Danish: Hvorfor er Vectra Felis godkendt i EU?
English: The field study involved 129 cats with flea infestations that were treated once a month for three consecutive months either with Vectra Felis or with another spot-on product containing two different substances, fipronil and (S)-methoprene, that control fleas.
Danish: Kattene blev behandlet én gang om måneden i tre på hinanden følgende måneder, enten med Vectra Felis eller med et andet spot-on produkt, der indeholder to andre stoffer mod lopper, nemlig fipronil og (S)-methopren.
English: What are the risks associated with Vectra Felis?
Danish: Hvilke risici er der forbundet med Vectra Felis?
English: For a full list of all side-effects reported with Vectra Felis, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger med Vectra Felis fremgår af indlægssedlen.
English: How is Vectra Felis used?
Danish: Hvordan anvendes Vectra Felis?
English: How does Vectra Felis work?
Danish: Hvordan virker Vectra Felis?
English: What benefits of Vectra Felis have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Vectra Felis?
English: Pyriproxyfen is an insect growth regulator which stops the flea life cycle by causing production of infertile eggs as well as by blocking the development of immature flea stages into adults.
Danish: Pyriproxyfen regulerer insekters vækst.
English: * adsorbed on aluminium phosphate
Danish: *adsorberet på aluminiumphosphat
English: 1 conjugated to protein D (derived from non-typeable Haemophilus influenzae) carrier protein
Danish: 1 konjugeret til protein D (fra ikke-kapselbærende Haemophilus influenzae)-bærerprotein
English: --1 1 dose (0.5 ml) contains: Pneumococcal polysaccharide serotype 1* 1
Danish: --1 1 dosis (0,5 ml) indeholder: Pneumokokpolysaccharid serotype 1* 1
English: 2 conjugated to tetanus toxoid carrier protein
Danish: 2 konjugeret til tetanus-toksoid-bærerprotein
English: Pneumococcal polysaccharide serotype 18C* 2
Danish: Pneumokokpolysaccharid serotype 18C* 2
English: 3 conjugated to diphtheria toxoid carrier protein
Danish: 3 konjugeret til difteri-toksoid-bærerprotein
English: 10 pre-filled syringes + 10 needles
Danish: 10 fyldte injektionssprøjter + 10 kanyler
English: Pneumococcal polysaccharide serotype 9V* 1
Danish: Pneumokokpolysaccharid serotype 9V* 1
English: Pneumococcal polysaccharide serotype 6B* 1
Danish: Pneumokokpolysaccharid serotype 6B* 1
English: The European Commission issued a decision on 13 July 2010.
Danish: Europa-Kommissionen traf en afgørelse den 13. juli 2010.
English: • essential hypertension;
Danish: • essentiel hypertension
English: Atacand is authorised in the EU via national procedures.
Danish: Atacand er godkendt i EU efter nationale procedurer.
English: Dr Pieter de Graeff (The Netherlands)
Danish: Dr. Pieter de Graeff (Nederlandene)
English: Why was Atacand reviewed?
Danish: Hvorfor blev Atacand vurderet igen?
English: Dr Alar Irs (Estonia)
Danish: Dr. Alar Irs (Estland)
English: There were little differences among Member States in the special warnings section.
Danish: Der var mindre forskelle mellem medlemsstaterne i afsnittet om særlige advarsler.
English: The CHMP recommended that Atacand should be used to treat adult patients with:
Danish: CHMP anbefalede, at Atacand skulle bruges til behandling af voksne patienter med:
English: What is Atacand?
Danish: Hvad er Atacand?
English: This helps blood pressure to drop, which also makes it easier for the heart to pump out blood.
Danish: Dette medvirker til at sænke blodtrykket, hvilket også gør det lettere for hjertet at pumpe blod rundt i kroppen.
English: The European Medicines Agency has completed a review of Atacand and associated names.
Danish: Det Europæiske Lægemiddelagentur (EMA) har foretaget en revurdering af Atacand og relaterede navne.
English: Atacand is also available in the EU under other trade names: Amias, Blopress, Kenzen, Parapres, Racanda and Ratacand.
Danish: Atacand markedsføres ligeledes i EU under andre særnavne: Amias, Blopress, Kenzen, Parapres, Racanda og Ratacand.
English: On 16 July 2009, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Atacand in the EU.
Danish: Den 16. juli 2009 henviste Europa-Kommissionen sagen til CHMP med henblik på harmonisering af markedsføringstilladelserne for Atacand i EU.
English: Some Member States had not approved the 32 mg dose for treating hypertension and there were differences in how heart failure was defined.
Danish: Visse medlemsstater havde ikke godkendt dosis på 32 mg til behandling af hypertension, og der var forskel på, hvordan hjerteinsufficiens blev defineret.
English: Atacand is a medicine used to treat essential hypertension (high blood pressure) in adults.
Danish: Atacand er et lægemiddel, der anvendes til behandling af essentiel hypertension (højt blodtryk) hos voksne.
English: It must also not be given to women in their second or third trimesters of pregnancy or to patients with severe liver impairment or cholestasis (problems with the elimination of bile).
Danish: Det må heller ikke gives til kvinder under andet og tredje trimester af graviditeten eller til patienter med svær leverinsufficiens eller kolestase (problemer med udskillelse af galde).