FrancophonIA/ELRC3.0 huggingface dataset:
English: The median duration of exposure to study treatment was 4.6 months (range: 0.1-24.1 months).
Danish: (spredning: 0,1-24,1 måneder).
English: EU/1/15/1023/007 6 capsules EU/1/15/1023/008 12 capsules EU/1/15/1023/009 24 capsules
Danish: Farydak 20 mg hårde kapsler EU/1/15/1023/007-009
English: - Keep this medicine out of the sight and reach of children.
Danish: • Opbevar lægemidlet utilgængeligt for børn.
English: Given its cytostatic/cytotoxic mode of action, breast-feeding is contraindicated during Farydak treatment (see section 4.3).
Danish: Amning er kontraindiceret under behandling med Farydak på grund af den cytostatiske/cytotoksiske virkningsmekanisme (se pkt.
English: • rash of small fluid-filled blisters, appearing on reddened skin, mouth or gums (signs of a potentially severe viral infection)
Danish: • udslæt med små væskefyldte blærer, som opstår på rødmende hud, i munden eller på gummerne
English: Platelet transfusions may be required as clinically indicated (see sections 4.2 and 4.8).
Danish: Trombocyttransfusioner kan være nødvendige som klinisk indiceret (se pkt.
English: How to store Farydak
Danish: Anvendelse af Farydak
English: Results showed that:
Danish: Resultaterne viste følgende:
English: This summary was last updated in 06-2017.
Danish: Dette sammendrag blev sidst ajourført i 06-2017.
English: The recommended dose is 5 mg once a day.
Danish: Den anbefalede dosis er 5 mg én gang dagligt.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Onglyza on 1 October 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Onglyza den 1. oktober 2009.
English: This is a summary of the European public assessment report (EPAR) for Onglyza.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Onglyza.
English: The full EPAR for Onglyza can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Onglyza findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Regarding safety, Onglyza is generally well tolerated.
Danish: Hvad angår sikkerheden, tåles Onglyza sædvanligvis godt.
English: The dose of Onglyza should be reduced to 2.5 mg once a day in patients with moderate or severe kidney problems.
Danish: Dosis af Onglyza bør reduceres til 2,5 mg en gang dagligt hos patienter med moderat eller svær nyresygdom.
English: Onglyza is available as tablets (2.5 and 5 mg) and can only be obtained with a prescription.
Danish: Onglyza fås som tabletter (2,5 og 5 mg) og udleveres kun efter recept.
English: Other information about Onglyza
Danish: Andre oplysninger om Onglyza
English: It works by blocking the breakdown of incretin hormones in the body.
Danish: Det virker ved at blokere nedbrydningen af inkretinhormoner i kroppen.
English: The European Medicine Agency therefore decided that Onglyza's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Onglyza opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Onglyza.
English: What measures are being taken to ensure the safe and effective use of Onglyza?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Onglyza?
English: It is used either on its own in patients who cannot take metformin (another diabetes medicine) or as ‘add-on' to other diabetes medicines, including insulin.
Danish: Det bruges enten alene hos patienter, der ikke kan tage metformin (et andet diabeteslægemiddel), eller som tillægsbehandling til andre diabeteslægemidler, herunder insulin.
English: This gives an indication of how well the blood glucose is controlled.
Danish: Dette giver en indikation af, hvor godt glukosen i blodet reguleres.
English: However, the results were not considered to be clinically relevant and the company withdrew its application for the use of saxagliptin as an initial combination medicine in previously untreated patients.
Danish: Resultaterne ansås imidlertid ikke for at være klinisk relevante, og virksomheden tilbagetrak sin ansøgning om anvendelse af saxagliptin som et initialt kombinationslægemiddel hos ikke tidligere behandlede patienter.
English: Saxagliptin does not work when the blood glucose is low.
Danish: Saxagliptin virker ikke, når blodsukkeret er lavt.
English: Onglyza contains the active substance saxagliptin.
Danish: Onglyza indeholder det aktive stof saxagliptin.
English: Together, these processes reduce blood glucose levels and help to control type 2 diabetes.
Danish: Sammenlagt sænker disse processer blodsukkerniveauet og er derved med til at kontrollere type 2diabetes.
English: If used in combination with a sulphonylurea (medicines that make the body produce insulin) or insulin, the dose of these medicines may need to be reduced to avoid hypoglycaemia (low blood sugar levels).
Danish: Hvis det tages med et sulfonylurinstof (lægemidler, der får kroppen til at producere insulin) eller insulin, er det muligvis nødvendigt at nedsætte dosis af disse lægemidler for at undgå hypoglykæmi (lave blodsukkerniveauer).
English: Saxagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Danish: Saxagliptin reducerer også den mængde glukose, der produceres af leveren, ved at øge insulinniveauet og mindske niveauet af hormonet glukagon.
English: It is not intended to provide practical advice on how to use Onglyza.
Danish: Det er ikke en praktisk vejledning i, hvordan Onglyza bør anvendes.
English: Why is Onglyza approved?
Danish: Hvorfor blev Onglyza godkendt?
English: The most common side effects with Onglyza (seen in more than 5 patients in 100) are upper respiratory tract infection (nose and throat infection), urinary tract infection and headache.
Danish: De hyppigste bivirkninger ved Onglyza (som optræder hos flere end 5 ud af 100 patienter), er infektioner i de øvre luftveje (næse- og halsinfektioner), urinvejsinfektioner og hovedpine.
English: What is Onglyza and what is it used for?
Danish: Hvad er Onglyza, og hvad anvendes det til?
English: For more information about treatment with Onglyza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Onglyza, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The active substance in Onglyza, saxagliptin, is a dipeptidyl peptidase 4 (DPP-4) inhibitor.
Danish: Det aktive stof i Onglyza, saxagliptin, er en dipeptidylpeptidase 4-hæmmer (DPP-4-hæmmer).
English: The main measure of effectiveness was the reduction in blood levels of a substance called glycosylated haemoglobin (HbA1c) after 24 weeks of treatment.
Danish: Virkningen blev hovedsagelig bedømt på faldet i blodets indhold af stoffet glykosyleret hæmoglobin (HbA1c) efter 24 ugers behandling.
English: In type 2 diabetes, the pancreas does not make enough insulin to control the level of glucose in the blood or the body is unable to use insulin effectively.
Danish: Ved type 2-diabetes er bugspytkirtlen ikke i stand til at producere tilstrækkeligt insulin til at regulere indholdet af glukose i blodet, eller også er kroppen ikke i stand til at udnytte insulin effektivt.
English: HbA1c levels were on average around 9% at the start of the study.
Danish: HbA1cniveauet lå gennemsnitligt på ca. 9 % ved undersøgelsens start.
English: HbA1c levels were around 8% at the start of the study.
Danish: HbA1c-niveauet lå på ca. 8 % ved undersøgelsens start.
English: A further study compared saxagliptin with metformin in patients who had not previously received substantial treatment with diabetes medicines.
Danish: I en yderligere undersøgelse blev saxagliptin sammenlignet med metformin hos patienter, der ikke tidligere havde fået væsentlig behandling med diabeteslægemidler.
English: What are the risks associated with Onglyza?
Danish: Hvilke risici er der forbundet med Onglyza?
English: Onglyza must not be used in people who are hypersensitive (allergic) to saxagliptin, any of the other ingredients or who have ever had a serious allergic reaction to any DPP-4 inhibitor.
Danish: Onglyza må ikke anvendes hos patienter, som er overfølsomme (allergiske) over for saxagliptin eller andre af indholdsstofferne, eller som tidligere har haft en alvorlig allergisk reaktion over for en DPP-4hæmmer.
English: By increasing levels of incretin hormones in the blood, saxagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high.
Danish: Ved at øge koncentrationerne af inkretinhormoner i blodet stimulerer saxagliptin bugspytkirtlen til at producere mere insulin, når blodsukkerniveauet er højt.
English: Onglyza has been shown to be effective at controlling blood glucose levels both on its own and as addon to other diabetes medicines.
Danish: Det er blevet påvist, at Onglyza er effektivt til at regulere blodsukkerniveauet, både alene og som tillægsbehandling til andre diabeteslægemidler.
English: Adding dapagliflozin to metformin reduced HbA1c levels by 1.2 percentage points.
Danish: Når dapagliflozin blev føjet til metformin, faldt HbA1c-niveauet med 1,2 procentpoint.
English: For the full list of all side effects reported with Onglyza, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Onglyza fremgår af indlægssedlen.
English: For practical information about using Onglyza, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Onglyza, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: In these studies saxagliptin was used as an ‘add-on' to other diabetes medicines in patients in whom previous treatment had failed.
Danish: Saxagliptin blev i disse undersøgelser anvendt som tillægsbehandling til andre diabeteslægemidler hos patienter, der ikke havde haft effekt af tidligere behandling.
English: Onglyza is a diabetes medicine used with diet and exercise to treat adults with type 2 diabetes to control their blood glucose (sugar) level.
Danish: Onglyza er et lægemiddel mod diabetes, der anvendes sammen med diæt og motion til at regulere blodsukkeret hos voksne med type 2-diabetes.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Onglyza 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 Onglyza.
English: How is Onglyza used?
Danish: Hvordan anvendes Onglyza?
English: What benefits of Onglyza have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Onglyza?
English: How does Onglyza work?
Danish: Hvordan virker Onglyza?
English: • In 257 patients who took saxagliptin with metformin and a sulphonylurea, HbA1c levels fell by around 0.7 percentage points, compared with a fall of 0.1 percentage points in patients who were given placebo in place of saxagliptin.
Danish: • Hos 257 patienter, som tog saxagliptin sammen med metformin og et sulfonylurinstof, faldt HbA1c-niveauet med ca. 0,7 procentpoint sammenlignet med et fald på 0,1 procentpoint hos patienter, som fik placebo i stedet for saxagliptin.
English: Saxagliptin, the active substance in Onglyza, has been shown to be more effective than placebo (a dummy treatment) at controlling blood glucose in 8 main studies in over 3,900 patients.
Danish: Det er i otte hovedundersøgelser med over 3 900 patienter blevet påvist, at det aktive stof i Onglyza, saxagliptin, er mere effektivt end placebo (en virkningsløs behandling) til at regulere blodsukkeret.
English: • In 534 patients not satisfactorily controlled with metformin alone, adding saxagliptin reduced HbA1c levels by around 0.9 percentage points and adding saxagliptin and dapagliflozin reduced HbA1c levels by 1.5 percentage points.
Danish: • Hos 534 patienter, som ikke kunne reguleres tilstrækkeligt med metformin alene, bevirkede tillægsbehandling med saxagliptin, at HbA1c-niveauet faldt med ca. 0,9 procentpoint, og tillægsbehandling med saxagliptin og dapagliflozin nedbragte HbA1c-niveauet med 1,5 procentpoint.
English: This leads to high levels of glucose in the blood.
Danish: Dette medfører forhøjet blodsukker.
English: • In 315 patients not satisfactorily controlled with metformin and dapagliflozin, adding saxagliptin to treatment with dapagliflozin and metformin reduced HbA1c levels by 0.5 percentage points, compared with a reduction of 0.2 percentage points when placebo was added to dapagliflozin and metformin.
Danish: • Hos 315 patienter, som ikke kunne reguleres tilstrækkeligt med metformin og dapagliflozin, bevirkede tilføjelse af saxagliptin til behandlingen med metformin og dapagliflozin et fald i HbA1cniveauet på 0,5 procentpoint sammenlignet med et fald på 0,2 procentpoint, når placebo blev tilføjet behandlingen med dapagliflozin og metformin.
English: • In 320 patients not controlled with metformin and saxagliptin, adding dapagliflozin to saxagliptin and metformin reduced HbA1c levels by 0.8 percentage points, compared with a reduction of 0.1 percentage points when placebo was added to saxagliptin and metformin.
Danish: • Hos 320 patienter, som ikke kunne reguleres med metformin og saxagliptin, bevirkede tilføjelse af dapagliflozin til behandlingen med saxagliptin og metformin et fald i HbA1c-niveauet på 0,8 procentpoint sammenlignet med et fald på 0,1 procentpoint, når placebo blev tilføjet behandlingen med saxagliptin og metformin.
English: • In 743 patients not satisfactorily controlled on metformin alone, HbA1c levels fell by around 0.7 percentage points (from around 8.1% to around 7.4%) in patients adding saxagliptin compared with a rise of around 0.1 percentage points in patients adding placebo.
Danish: • Hos 743 patienter, som ikke kunne reguleres tilstrækkeligt med metformin alene, faldt HbA1cniveauet med ca. 0,7 procentpoint (fra ca. 8,1 % til ca. 7,4 %) hos patienter, som fik tillægsbehandling med saxagliptin, sammenlignet med en stigning på ca. 0,1 procentpoint hos patienter, som fik tillægsbehandling med placebo.
English: • In 457 patients not satisfactorily controlled on insulin (with or without metformin), HbA1c levels fell by around 0.7 percentage points in patients adding saxagliptin compared with a fall of around 0.3 percentage points in patients adding placebo.
Danish: • Hos 457 patienter, som ikke kunne reguleres tilstrækkeligt med insulin (med eller uden metformin), faldt HbA1c-niveauet med ca. 0,7 procentpoint hos patienter, som fik saxagliptin som tillægsbehandling, sammenlignet med et fald på ca. 0,3 procentpoint hos patienter, som fik placebo som tillægebehandling.
English: • In 768 patients not satisfactorily controlled on a sulphonylurea, HbA1c levels fell by around 0.6 percentage points in patients adding saxagliptin compared with a rise of around 0.1 percentage points in patients who added placebo.
Danish: • Hos 768 patienter, som ikke kunne reguleres tilstrækkeligt med et sulfonylurinstof, faldt HbA1cniveauet med ca. 0,6 procentpoint hos patienter, som fik tillægsbehandling med saxagliptin, sammenlignet med en stigning på ca. 0,1 procentpoint hos patienter, som fik tillægsbehandling med placebo.
English: • In 565 patients not satisfactorily controlled on a thiazolidinedione (diabetes medicines such as pioglitazone and rosiglitazone), HbA1c levels fell by around 0.9 percentage points in patients adding saxagliptin compared with a fall of around 0.3 percentage points in patients who added placebo.
Danish: • Hos 565 patienter, som ikke kunne reguleres tilstrækkeligt med et thiazolidindion (diabeteslægemidler såsom pioglitazon og rosiglitazon), faldt HbA1c-niveauet med ca.
English: Saxagliptin given on its own has also been shown to be more effective than placebo at controlling blood glucose in four studies: in patients given saxagliptin HbA1c levels fell by around 0.5 percentage points more than in patients given placebo.
Danish: Hos de patienter, som fik saxagliptin, faldt HbA1c-niveauet med ca. 0,5 procentpoint mere end hos de patienter, der fik placebo.
English: Where necessary, cats can be re-treated at 12-week intervals.
Danish: Om nødvendigt kan katte genbehandles med 12 ugers mellemrum.
English: Each cardboard box contains 1 or 2 pipettes.
Danish: Hver æske indeholder 1 eller 2 pipetter.
English: ATCvet code: QP54AB52.
Danish: ATCvet-kode: QP54AB52.
English: Date of first authorisation: 08/05/2018
Danish: Dato for første markedsføringstilladelse: 08/05/2018
English: It takes up to 48 hours for the application site to become dry but it will be noticeable for longer.
Danish: Det tager op til 48 timer, før applikationsstedet er tørt, men det vil være synligt i længere tid.
English: Within each weight band, the content of one whole pipette should be used.
Danish: Inden for hver vægtgruppe skal indholdet af en hel pipette anvendes.
English: This includes cuddling the animal and sharing a bed with the animal.
Danish: Dette gælder også at kæle med dyret og dele seng med det.
English: This product can cause eye irritation.
Danish: Dette produkt kan forårsage øjenirritation.
English: The period between treatment and return from the endemic areas should not exceed 60 days.
Danish: Perioden mellem behandling og tilbagevenden fra det endemiske område bør ikke overstige 60 dage.
English: Butylhydroxytoluene Dimethylacetamide Glycofurol
Danish: Butylhydroxytoluen Dimethylacetamid Glycofurol
English: Diethyltoluamide (DEET) Acetone
Danish: Diethyltoluamid (DEET) Acetone
English: Do not allow recently treated animals to groom each other.
Danish: Tillad ikke nyligt behandlede dyr at slikke på hinanden.
English: Fluralaner is an acaricide and insecticide.
Danish: Fluralaner er et acaricid og insekticid.
English: Do not use this veterinary medicinal product after the expiry date stated on the packaging after EXP.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på emballagen efter forkortelsen 'EXP'.
English: This product is for topical use and should not be administered orally.
Danish: Dette produkt er beregnet til topikal anvendelse og må ikke administreres oralt.
English: Step 3: Squeeze the pipette gently and apply the entire contents directly to the cat's skin.
Danish: Trin 3: Klem forsigtigt på pipetten og påfør hele indholdet direkte på kattens hud.
English: Intervet Productions Rue de Lyons 27460 Igoville FRANCE
Danish: Intervet Productions Rue de Lyons 27460 Igoville FRANKRIG
English: In some cases, soap and water is not sufficient to remove the product spilled on the fingers, therefore gloves must be used.
Danish: I nogle tilfælde er vand og sæbe ikke tilstrækkeligt til at fjerne produktet fra fingrene, derfor skal der anvendes handsker.
English: In the absence of available data, treatment of kittens less than 9 weeks of age and cats less than 1.2 kg bodyweight is not recommended.
Danish: På grund af manglende data anbefales produktet ikke til behandling af killinger, som er under 9 uger gamle, og katte, der vejer mindre end 1,2 kg.
English: A used pipette should immediately be disposed of.
Danish: Den brugte pipette skal smides ud med det samme.
English: Contact may occur either directly, when handling the product, or when handling the treated animal.
Danish: Der kan være tale om enten direkte kontakt, når produktet håndteres, eller kontakt med det behandlede dyr.
English: The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
Danish: Produktet kan anvendes som del af en behandlingsstrategi ved loppebetinget allergisk dermatitis (FAD).
English: For the prevention of heartworm disease caused by Dirofilaria immitis for 8 weeks.
Danish: Til forebyggelse af hjerteormsinfektion forårsaget af Dirofilaria immitis i 8 uger.
English: The effect on Dirofilaria immitis larvae has been shown to last over a period of 60 days after treatment with the product.
Danish: Effekten på Dirofilaria immitis larver er påvist at vare i en periode på 60 dage efter behandling med produktet.
English: An in vitro study also demonstrated that very low concentrations of fluralaner stop the production of viable eggs by fleas.
Danish: Et in vitrostudie viste også, at meget lave koncentrationer af fluralaner forhindrer produktionen af levedygtige æg fra lopper.
English: Weight of cat (kg)
Danish: Kattens vægt (kg)
English: Intervet UK Limited Walton Manor Walton
Danish: Intervet UK Limited Walton Manor
English: Do not allow treated animals to come into contact with untreated animals until the application site is dry.
Danish: Lad ikke behandlede dyr komme i kontakt med ubehandlede dyr, før påføringsstedet er tørt.
English: Macrocyclic lactones including moxidectin have been shown to be substrates for p-glycoprotein.
Danish: Makrocykliske laktoner, herunder moxidectin, er blevet påvist at være substrater af P-glykoprotein.
English: It is important to apply the dose as indicated to prevent the animal from licking and ingesting the product.
Danish: Det er vigtigt at påføre den anbefalede dosis som angivet for at forhindre dyret i at slikke produktet af og indtage det.
English: Parasite control is recommended throughout the period of potential infestation risk.
Danish: Parasitkontrol anbefales i hele den periode, hvor der er risiko for infestation.
English: The pipette is open and ready for application when the breaking of the seal is felt.
Danish: Pipetten er åben og klar til brug, når man mærker, at forseglingen er brudt.
English: Pregnancy, lactation and fertility:
Danish: Drægtighed, diegivning og fertilitet:
English: If skin contact does occur, wash the affected area immediately with soap and water.
Danish: I tilfælde af kontakt med huden skal det berørte område straks vaskes med vand og sæbe.
English: The safety of the veterinary medicinal product has not been established in pregnant or lactating animals and therefore use in such animals is not recommended.
Danish: Sikkerheden af veterinærlægemidlet er ikke fastlagt hos drægtige eller diegivende dyr; derfor anbefales det ikke til brug hos sådanne dyr.
English: The product binds to skin and may also bind to surfaces after spillage of the product.
Danish: Produktet bindes til huden; det kan også bindes til overflader efter spild.
English: No therapeutic effect against adult Dirofilaria immitis has been established.
Danish: Der er ikke påvist nogen behandlingsmæssig virkning mod voksne Dirofilaria immitis.
English: Seek further veterinary examination (i.e. otoscopy) 28 days after treatment to determine whether there is re-infestation requiring additional treatment.
Danish: Yderligere veterinær undersøgelse (dvs. otoskopi) skal foretages 28 dage efter behandling for konstatering af eventuel reinfestation, som kræver yderligere behandling.
English: The flea life cycle is broken due to the rapid onset of action and long lasting efficacy against adult fleas on the animal and the absence of viable egg production.
Danish: Loppens livscyklus brydes på grund af den hurtigt indsættende virkning og langvarige effekt over for voksne lopper på dyret og manglende produktion af levedygtige æg.
English: People with a sensitive skin or known allergy in general e.g. to other veterinary medicinal products of this type should handle the veterinary medicinal product as well as treated animals with caution.
Danish: Personer med sart hud eller kendt allergi i almindelighed, fx over for andre veterinærlægemidler af denne type, skal håndtere veterinærlægemidlet og behandlede dyr med forsigtighed.
English: Step 2: The cat should be standing or lying with its back horizontal for easy application.
Danish: Trin 2: Katten skal stå eller ligge med ryggen i vandret stilling for at lette påføringen.
English: Clear colourless to yellow solution.
Danish: Klar, farveløs til gul opløsning.