FrancophonIA/ELRC3.0 huggingface dataset:
English: Activyl is used to treat and prevent flea infestations in dogs and cats and to treat flea allergy dermatitis (an allergic reaction to flea bites).
Danish: Activyl anvendes til behandling og forebyggelse af loppeangreb hos hunde og katte og til behandling af loppeforårsaget dermatitis (en allergisk reaktion på loppebid).
English: The effectiveness against the specified parasites was investigated in both laboratory studies and in five field studies (four for the spot-on for cats or dogs only and one for both cats and dogs).
Danish: Produktets virkning over for de angivne parasitter blev undersøgt i laboratorieundersøgelser såvel som i fem feltundersøgelser (fire for spot-on-pipetterne kun til katte eller hunde og én for spot-on-pipetter til både katte og hunde).
English: The active substance in Activyl, indoxacarb, is an ectoparasiticide.
Danish: Det aktive stof i Activyl, indoxacarb, er et ektoparasitdræbende middel.
English: This is thought to be the result of licking the application site straight after treatment.
Danish: Man mener, dette sker, når dyret slikker sig på påføringsstedet umiddelbart efter behandlingen.
English: Animals should not be stroked, groomed or allow to groom each other, until the application site is dry, and they should not be allowed to swim or treated with shampoo within 48 hours after treatment.
Danish: Dyrene bør desuden ikke vaskes med shampoo eller tillades at svømme i de første 48 timer efter behandling.
English: The studies also showed that Activyl helps with the management of allergic flea dermatitis.
Danish: Undersøgelserne viste desuden, at Activyl hjælper med at kontrollere loppeforårsaget dermatitis.
English: It is available as a clear, colourless to yellow solution presented as a ‘spot-on' in pipettes already filled with the correct amount of Activyl needed to treat one cat or dog depending on its weight (5 sizes of pipettes for different dog weights and 2 sizes of pipettes for different cat weights).
Danish: Det fås som en klar, farveløs til gul opløsning i form af spot-on-pipetter, der allerede er fyldt med den rette mængde Activyl til behandling af én kat eller én hund, afhængig af dyrets vægt (pipetterne leveres i forskellige størrelser til forskellige vægtklasser, fem for hunde og to for katte).
English: For a full list of all side-effects reported with Activyl, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Activyl fremgår af indlægssedlen.
English: The effectiveness was measured by counting of fleas, flea allergy dermatitis assessment, observations on local reactions at the application site after treatment.
Danish: Virkningen blev målt ved at tælle lopper, vurdere forekomsten af loppeforårsaget dermatitis og observere forekomsten af lokale reaktioner på påføringsstedet efter behandling.
English: What is Activyl?
Danish: Hvad er Activyl?
English: There might also be some temporary itchiness, inflammation or hair loss at the place where the product has been applied to the skin.
Danish: Der kan også forekomme forbigående kløe, betændelse og hårtab på påføringsstedet.
English: What benefit has Activyl shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Activyl?
English: What is Activyl used for?
Danish: Hvad anvendes Activyl til?
English: They should not smoke, eat or drink, and should wash their hands thoroughly after use.
Danish: Brugeren bør ikke ryge eller indtage mad og drikke og bør efter brug vaske hænderne grundigt.
English: How has Activyl been studied?
Danish: Hvordan blev Activyl undersøgt?
English: A reduction in symptoms of flea allergy dermatitis was recorded in both target species.
Danish: Hos begge de undersøgte arter observeredes der en reduktion i symptomerne på loppeforårsaget dermatitis.
English: After application, indoxacarb is eaten by the insects and activated in their gut into an active compound.
Danish: fortæres det af insekterne, hvorefter det aktiveres i deres tarme og danner et aktivt stof.
English: How does Activyl work?
Danish: Hvordan virker Activyl?
English: Moreover, the intended use does not require medical supervision.
Danish: Desuden kræver den tilsigtede anvendelse ikke lægeligt opsyn.
English: The plant is cultivated or gathered to obtain the seeds for medicinal use.
Danish: Planten dyrkes eller indsamles for at indhente frøene til medicinsk anvendelse.
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Danish: at disse plantelægemidler har en virkning, og der er dokumentation for, at de har været anvendt sikkert på denne måde i mindst 30 år (herunder mindst 15 år i EU).
English: Guarana seed should only be used in adults.
Danish: Guaranafrø bør kun anvendes til voksne.
English: At the time of the HMPC assessment, no side effects had been reported with these medicines.
Danish: På tidspunktet for HMPC's vurdering var der ikke indberettet bivirkninger for disse lægemidler.
English: Guarana seed is the common name for the seed of the plant Paulinia cupana Kunth ex H.B.K.
Danish: Guaranafrø er fællesnavnet for frø fra planten Paulinia cupana Kunth ex H.B.K.
English: What is guarana seed?
Danish: Hvad er guaranafrø?
English: Guarana seed
Danish: Guaranafrø
English: Guarana seed EMA/HMPC/284498/2013
Danish: Guaranafrø EMA/HMPC/284498/2013
English: Herbal medicines containing guarana seed are usually available in solid forms to be taken by mouth.
Danish: Plantelægemidler med guaranafrø, er normalt tilgængelige i fast form, der skal tages gennem munden.
English: The HMPC recommended that these medicines should not be used in patients with stomach and gut ulcers, hyperthyroidism (overactive thyroid gland) or cardiovascular problems, such as hypertension (high blood pressure) and arrhythmias (heart rhythm problems).
Danish: HMPCanbefaler at disse lægemidler ikke anvendes til patienter med sår i mave- og tarm-regionen, overaktiv skjoldbruskkirtel (hyperthyroidisme) eller hjerte-kar sygdomme såsom forhøjet blodtryk (hypertension) og uregelmæssig hjerterytme (arytmier).
English: For detailed information on the studies assessed by the HMPC, see the HMPC assessment report.
Danish: Nærmere oplysninger om de undersøgelser, HPMC har vurderet, findes i HMPC's vurderingsrapport.
English: Guarana seed can also be found in combination with other herbal substances in some herbal medicines.
Danish: Guaranafrø findes også sammen med andre droger i visse plantelægemidler.
English: Information on the use and licensing of guarana seed medicines in EU Member States should be obtained from the relevant national authorities.
Danish: Oplysninger om anvendelse og godkendelse i EU's medlemsstater af lægemidler, der indeholder guaranafrø, skal indhentes fra de relevante nationale myndigheder.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of guarana seed.
Danish: Dette er et sammendrag af Udvalget for Plantelægemidlers (HMPC) videnskabelige konklusioner vedrørende den medicinske anvendelse af guaranafrø.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing guarana seed.
Danish: EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder guaranafrø.
English: Any applications for the licensing of medicines containing guarana seed have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Danish: Ansøgninger om godkendelse af lægemidlermed guaranafrø, skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner.
English: Detailed instructions on how to take guarana seed medicines and who can use them can be found in the package leaflet that comes with the medicine.
Danish: Detaljerede anvisninger for, hvordan lægemidlermed guaranafrø skal anvendes, og hvem der kan bruge dem, findes i indlægssedlen, der ligger i lægemiddelpakningen.
English: Further information on the risks associated with guarana seed medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om risici forbundet med lægemidler indeholdende guaranafrø, herunder passende forholdsregler, som skal følges med henblik på sikker anvendelse, findes i monografien under fanebladet "All documents" på agenturets websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Further information on the HMPC assessment of guarana seed medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om HMPC's vurdering af lægemidler, der indeholder guaranafrø, herunder nærmere oplysninger om udvalgets konklusioner, findes under "All documents" på agenturets websted under ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Other information about guarana seed medicines
Danish: Andre oplysninger om lægemidler, der indeholder guaranafrø
English: This summary is not intended to provide practical advice on how to use medicines containing guarana seed.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder guaranafrø, anvendes.
English: If symptoms persist for longer than one week during the use of Guarana seed, a qualified healthcare practitioner should be consulted.
Danish: Hvis symptomerne varer længere end en uge, når du bruger guaranafrø, bør der søges råd hos en læge eller på apoteket.
English: How are guarana seed medicines approved in the EU?
Danish: Hvordan godkendes lægemidler, der indeholder guaranafrø, i EU?
English: What are the risks associated with guarana seed medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder guaranafrø?
English: The HMPC concluded that, on the basis of its long-standing use, guarana seed can be used for the relief of symptoms of fatigue (tiredness) and weakness.
Danish: HPMC konkluderede, at guaranafrø på baggrund af den mangeårige brug kan anvendes til lindring af symptomer på træthed og svaghed.
English: The HMPC conclusions on the use of guarana seed medicines for fatigue and weakness are based on their ‘traditional use'.
Danish: HMPC's konklusioner vedrørende brugen af lægemidler med guaranafrø er baseret på lægemidlernes "traditionelle brug" mod træthed og svaghed.
English: What evidence supports the use of guarana seed medicines?
Danish: Hvilken dokumentation underbygger den medicinske anvendelse af lægemidler med guaranafrø?
English: EMA/HMPC/284498/2013
Danish: EMA/HMPC/284498/2013 Udvalget for Plantelægemidler (HMPC)
English: For more information about treatment with guarana seed medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med lægemidler, der indeholder guaranafrø, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: In its assessment, the HMPC considered studies on the effects of guarana seed on behaviour, which showed that it had a stimulant effect and led to improvements in symptoms of fatigue.
Danish: Undersøgelserne viste, at guaranafrø havde en stimulerende virkning og medførte en bedring af symptomer på træthed.
English: For practical information about using guarana seed medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktiske oplysninger om anvendelsen af lægemidler med guaranafrø, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: Guarana seed preparations are obtained by drying and powdering the seeds.
Danish: Guaranafrø anvendes i form af tørrede, pulveriserede frø.
English: Intravenous use vial (plastic)
Danish: hætteglas (plastik)
English: Intravenous use vial (glass)
Danish: Pakningsstørrelse hætteglas (glas)
English: Pharmaceutical Form Route of Administration
Danish: Styrke Lægemiddelform Administration Emballage Indhold (Koncentration)
English: --1 Cell-associated live recombinant turkey herpesvirus expressing the fusion protein of Newcastle disease virus and the VP2 protein of infectious bursal disease virus: 103.3 - 104.6 PFU* * PFU: plaque forming units.
Danish: --1 Celleassocieret levende, rekombinant kalkunherpesvirus, der udviser fusionsprotein Newcastle disease virus og VP2 protein over for infektiøs bursal disease virus:
English: Invented name Strength Pharmaceutical form
Danish: Styrke Lægemiddelform Dyrearter, som lægemidlet er beregnet til
English: The European Commission granted a marketing authorisation valid throughout the European Union for Exubera on 24 January 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse for Exubera med gyldighed i hele Den Europæiske Union den 24. januar 2006.
English: For the full description of the side effects reported with
Danish: Den fuldstændige beskrivelse af de indberettede bivirkninger for
English: Smokers must have stopped smoking for at least 6 month before they can take Exubera.
Danish: Rygere skal have ophørt med rygningen i mindst 6 måneder, før de må bruge Exubera.
English: Exubera is given within 10 minutes before the start of a meal.
Danish: Exubera gives inden for 10 minutter før, patienten begynder på et måltid.
English: How has Exubera been studied?
Danish: Hvordan er Exubera blevet undersøgt?
English: Patients with poor or unstable lung function, such as asthma, emphysema or chronic bronchitis, should not use Exubera.
Danish: Patienter med dårlig eller ustabil lungefunktion, således astma, emfysem eller kronisk bronkitis, må ikke bruge Exubera.
English: When inhaled, some of the insulin is absorbed into the blood (the rest is broken down in the lungs).
Danish: Når insulinet inhaleres, vil noget af det blive optaget i blodet (resten nedbrydes i lungerne).
English: By controlling the level of blood sugar, the symptoms and complications of diabetes are reduced.
Danish: Gennem regulering af blodsukkeret mindskes symptomerne og komplikationerne ved sukkersygen.
English: It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Danish: Formålet er at forklare, hvordan Udvalget for Humanmedicinske Lægemidlers (CHMP) vurdering af de gennemførte undersøgelser førte til, at man anbefalede at anvende lægemidlet
English: This depends on the patient's response and requirements (e.g. diet, physical activity and life-style).
Danish: Lægen afgør dette ud fra, hvordan behandlingen virker på patienten, og ud fra patientens behov (f.eks. kost, fysisk aktivitet og livsstil).
English: To take a dose, the patient places the blister in the inhaler, and inhales it through the mouth into the lungs.
Danish: For at tage en dosis sætter patienten blisteren i inhalatoren og indånder den i lungerne gennem munden.
English: The company that makes Exubera will carry out studies to further test its safety, particularly in patients who might have an increased risk of side effects, such as patients with asthma or chronic obstructive pulmonary disease.
Danish: Firmaet, der fremstiller Exubera, skal foretage supplerende undersøgelser af midlets sikkerhed, specielt hos patienter med forhøjet risiko for bivirkninger, f.eks. patienter med astma eller kronisk obstruktiv lungesygdom.
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part
Danish: Hvis du ønsker yderligere oplysninger på grundlag af CHMPs anbefalinger, kan du læse den faglige
English: If a patient already has lung disease, it is not clear how the use of Exubera affects their lungs or how the lung disease affects the intake of insulin from the lungs.
Danish: Har patienten i forvejen en lungesygdom, er det ikke klart, hvordan brug af Exubera påvirker lungerne, eller hvordan lungesygdommen påvirker optagelsen af insulin fra lungerne.
English: The most common side effects of Exubera are hypoglycaemia (low blood glucose) and cough.
Danish: De almindeligste bivirkninger ved Exubera er hypoglykæmi (for lavt blodsukker) og hoste.
English: Exubera has been studied in patients with type 2 or type 1 diabetes.
Danish: Exubera er undersøgt hos patienter med type 2- og type 1-sukkersyge.
English: So Exubera is not suitable when small (less than 3 IU) adjustments of insulin are necessary (for example in patient with low body weight).
Danish: Exubera er derfor ikke velegnet, når det er nødvendigt med små justeringer (mindre end 3 IE) af dosis - for eksempel til patienter med lav
English: If a patient starts or resumes smoking when treated with Exubera, they must use another anti-diabetic treatment immediately.
Danish: Hvis en patient begynder at ryge eller genoptager rygningen under behandlingen med Exubera, skal vedkommende straks skifte til anden sukkersygebehandling.
English: A doctor decides for each patient the starting doses and the timing of the doses, and the dose adjustment schedule.
Danish: Lægen afgør for den enkelte patient, hvad startdosis skal være, hvornår medicinen skal tages, og hvordan dosis skal justeres.
English: Diabetes is a disease in which the body does not produce enough insulin to control the level of blood sugar.
Danish: Sukkersyge er en sygdom, hvor kroppen ikke producerer tilstrækkeligt med insulin til at regulere blodsukkeret.
English: What is the risk associated with Exubera?
Danish: Hvilken risiko er der forbundet med Exubera?
English: The studies measured the level in the blood of glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Danish: I forsøgene har man målt blodets indhold af et glykosyleret hæmoglobin (HbA1c), der fortæller, hvor godt blodets sukkerindhold bliver reguleret.
English: They will also look at the development of insulin antibodies (proteins that are produced in response to treatment with Exubera).
Danish: Desuden skal det undersøges, om patienterne kan danne antistoffer mod insulinet (proteiner, der produceres som reaktion på behandlingen med Exubera).
English: During the studies, Exubera showed a small negative effect on lung function that may disappear when Exubera is stopped.
Danish: Undersøgelserne har vist, at Exubera har en lille negativ virkning på lungefunktionen, hvilket muligvis ophører, når behandlingen med Exubera standses.
English: If a patient smokes, the amount of insulin that is absorbed from the lungs greatly increases and this may increase the risk of hypoglycaemia.
Danish: Hvis patienten er ryger, optages der betydeligt mere insulin fra lungerne, hvilket kan øge risikoen for hypoglykæmi.
English: Exubera is a replacement insulin which is identical to the insulin made by the pancreas.
Danish: Exubera er et erstatningsinsulin, der er identisk med det insulin, der produceres af bugspytkirtlen.
English: Three 1 mg doses should not be used instead of one 3 mg dose because this gives a higher insulin dose and may increase the risk of hypoglycaemia.
Danish: Man må ikke tage tre 1 mg blistre som erstatning for én 3 mg blister, da det giver en højere insulindosis og kan øge risikoen for hypoglykæmi.
English: Exubera should not be used in people who may be hypersensitive (allergic) to human insulin or any of
Danish: Exubera må ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for humant
English: The Committee for Medicinal products for Human Use (CHMP) decided that Exubera's benefits are greater than its risks in certain adult patients with diabetes when used as described in the Product information, and recommended that Exubera be given marketing authorisation.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Exubera er større end risiciene til behandling af sukkersyge hos visse voksne patienter, når produktet anvendes som beskrevet i produktresuméet.
English: Exubera is a fast-acting insulin powder for inhalation (breathing in).
Danish: Exubera er hurtigtvirkende insulin i pulverform til inhalation (indånding).
English: What are the measures to minimise the risk associated with Exubera?
Danish: Hvilke foranstaltninger kan mindske risikoen ved Exubera til det mindst mulige?
English: Exubera is used only with its insulin inhaler.
Danish: Exubera anvendes kun ved hjælp af den tilhørende insulininhalator.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) EXUBERA EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) EXUBERA
English: Exubera works in type 1 diabetes, when the pancreas cannot produce enough insulin, and in type 2 diabetes when the body is unable to use insulin effectively.
Danish: Exubera virker ved type 1-sukkersyge, hvor bugspytkirtlen ikke kan producere nok insulin, og ved type 2-sukkersyge, hvor kroppen ikke kan udnytte insulinet effektivt.
English: Exubera is an insulin used for the treatment of adults with type 2 diabetes, when it is not properly controlled with anti-diabetes tablets.
Danish: Exubera er et insulin, der anvendes til behandling af voksne med type 2 sukkersyge (diabetes), når sukkersygen ikke kan reguleres tilstrækkeligt med tabletter.
English: Patients must not smoke while taking Exubera.
Danish: Rygere må ikke bruge Exubera.
English: The company will also monitor side effects, provide educational material, and improve the design of the blister packs so that it is easier to tell the
Danish: Firmaet skal endvidere overvåge bivirkninger, udlevere informationsmateriale og forbedre blisterpakningens udformning, så det er lettere at se forskel på 1 mg og 3 mg enkeltdosisblister.
English: Before starting Exubera, a doctor or a nurse must explain to the patient how to use the inhaler properly to minimise risk and ensure that the patient gets the best benefit from their treatment.
Danish: Før start af behandlingen med Exubera skal en læge eller sygeplejerske forklare patienten, hvordan inhalatoren bruges korrekt.
English: Overall, in studies in type 1 and type 2 diabetes, Exubera gave similar blood glucose control to that given by fast-acting subcutaneous human insulin.
Danish: Samlet gav Exubera i undersøgelser af type 1- og type 2-sukkersyge lige så god blodsukkerkontrol som hurtigtvirkende humant insulin indgivet subkutant.
English: The insulin in Exubera is produced by a method known as ‘recombinant DNA technology' which means that the insulin is made by a bacterium which has received a gene (DNA) that makes it able to produce the insulin.
Danish: Det vil sige, at insulinet produceres af en bakterie, der har fået indsat et gen (dna), som gør den i stand til at producere insulin.
English: Exubera can also be used for certain adults with type 1 diabetes, who can benefit from replacing fast-acting subcutaneous insulin by this inhaled insulin, taking into
Danish: Exubera kan desuden bruges til nogle voksne med type 1 sukkersyge, som kan have gavn af at bruge inhalationspulveret i stedet for indsprøjtninger af hurtigtvirkende insulin under huden, når de mulige risici tages i betragtning.
English: In type 2 diabetes, Exubera was compared to subcutaneous insulin, and to oral anti-diabetes medicines.
Danish: Ved type 2-sukkersyge blev Exubera sammenlignet med subkutant insulin og med tabletter mod sukkersyge (orale antidiabetika).
English: In type 1 diabetes, Exubera was compared to subcutaneous (injected) insulin.
Danish: Ved type 1-sukkersyge blev Exubera sammenlignet med subkutant insulin (indsprøjtet under huden).
English: Exubera contains 1 mg or 3 mg of
Danish: Exubera findes i to styrker, der indeholder henholdsvis 1 mg og 3 mg af det aktive stof, humant insulin.