FrancophonIA/ELRC3.0 huggingface dataset:
English: Saxagliptin/dapagliflozin combination: Cardiovascular (CV) events that were adjudicated and confirmed as CV events were reported in a total of 1.0 % of subjects in the saxagliptin plus dapagliflozin plus metformin group, 0.6 % in the saxagliptin plus metformin group, and 0.9 % in the dapagliflozin plus metformin group.
Danish: Saxagliptin/dapagliflozin-kombination: Kardiovaskulære (CV) bivirkninger, der blev vurderet og bekræftet som værende CV-bivirkninger, blev rapporteret hos i alt 1,0 % af forsøgspersonerne i saxagliptin plus dapagliflozin plus metformin-gruppen, hos 0,6 % i saxagliptin plus metformin-gruppen og hos 0,9 % i dapagliflozin plus metformin-gruppen.
English: Add-on therapy with dapagliflozin in patients inadequately controlled on saxagliptin plus metformin A 24-week randomised, double-blind, placebo-controlled study compared the sequential addition of 10 mg dapagliflozin to 5 mg saxagliptin and metformin to the addition of placebo to 5 mg saxagliptin (DPP-4 inhibitor) and metformin in patients with type 2 diabetes mellitus and inadequate glycaemic control (HbA1c ≥ 7% and ≤ 10.5%).
Danish: Et randomiseret, dobbeltblindt, placebokontrolleret studie af 24 ugers varighed sammenlignede efterfølgende tillæg af 10 mg dapagliflozin til 5 mg saxagliptin og metformin med tillæg af placebo til 5 mg saxagliptin (DPP-4-hæmmer) og metformin hos patienter med type 2-diabetes mellitus og utilstrækkelig glykæmisk kontrol (HbA1c ≥ 7 % og ≤ 10,5 %).
English: The adverse reactions of Qtern are presented in table 1 based on the summarized data from the saxagliptin/dapagliflozin combination clinical trials pooled safety data.
Danish: De er baseret på sammenfattede data fra puljede sikkerhedsdata fra kliniske studier med kombinationen saxagliptin/dapagliflozin.
English: Therefore, in keeping with routine care of the diabetic patient, monitoring for skin disorders, such as blistering, ulceration or rash, is recommended.
Danish: Derfor anbefales det at monitorere for hudlidelser f.eks. blærer, ulcerationer eller udslæt i forbindelse med de normale kontroller af diabetespatienter.
English: (sinusitis) - inflamed nose or throat (nasopharyngitis) (signs of this may include a cold or a sore throat) - stomach ache and indigestion (dyspepsia) - nausea - diarrhoea - inflamed stomach or gut usually caused by an infection (gastroenteritis) - headache, muscle pain (myalgia) - vomiting, inflammation of the stomach (gastritis) - changes in laboratory tests (for example creatinine renal clearance decreased or haematocrit increased).
Danish: - øgning af antal røde blodlegemer (ses i blodprøver) - nedsat kreatininclearance (ses i blodprøver) - svimmelhed - træthed - mavepine - svære ledsmerter - infektion i den øvre del af brystet eller lungerne - bihulebetændelse med en følelse af smerte og hævelse bag kinder og øjne - betændelse i næse eller svælg (tegn på dette kan omfatte forkølelse eller ondt i halsen) - mavepine og fordøjelsesbesvær (dyspepsi) - kvalme - diarré - betændelse i mave eller tarme, der normalt skyldes en infektion (gastroenteritis) - hovedpine, muskelsmerter - opkastning, mavekatar - ændringer i laboratorieprøver (for eksempel nedsat udskillelse af kreatinin fra nyrerne eller forhøjet hæmatokrit) - udslæt.
English: Ulcerative and necrotic skin lesions have been reported in extremities of monkeys in non-clinical toxicology studies with saxagliptin (see section 5.3).
Danish: I prækliniske toksikologi-studier med saxagliptin er der blevet rapporteret tilfælde af ulcerative og nekrotiske hudlæsioner på ekstremiteter hos aber (se pkt.
English: Use in patients with hepatic impairment
Danish: Anvendelse til patienter med nedsat leverfunktion
English: Post-marketing reports of rash have been described in the DPP-4 inhibitor class.
Danish: Efter markedsføring er udslæt indberettet i forbindelse med DPP-4-hæmmere (klasseeffekt).
English: Dysuria, polyuria
Danish: Dysuri, polyuri
English: While a causal relationship between dapagliflozin and bladder cancer is unlikely (see sections 4.8 and 5.3), as a precautionary measure, Qtern is not recommended for use in patients concomitantly treated with pioglitazone.
Danish: 4.8 og 5.3), bør Qtern af forsigtighedsmæssige hensyn ikke anvendes til patienter, der er i behandling med pioglitazon.
English: If any of the above apply to you (or if you are not sure), talk to your doctor before taking Qtern.
Danish: Tal med lægen, før du tager Qtern, hvis noget af ovenstående gælder for dig (eller hvis du er i tvivl).
English: (sulphonylurea), a reduction in the dose of sulphonylurea may be required to minimize the risk of hypoglycaemia (see section 4.8).
Danish: Hvis Qtern anvendes i kombination med et insulinsekretionsfremmende middel (sulfonylurinstof), kan det derfor være nødvendigt at reducere dosis af sulfonylurinstoffet for at minimere risikoen for hypoglykæmi (se pkt.
English: Add-on therapy with saxagliptin in patients inadequately controlled on dapagliflozin plus metformin A 24-week randomised, double-blind, placebo-controlled study conducted on patients with type 2 diabetes mellitus and inadequate glycaemic control (HbA1c ≥ 7 % and ≤ 10.5 %) on metformin and dapagliflozin alone, compared the sequential addition of 5 mg saxagliptin to 10 mg dapagliflozin and metformin, to the addition of placebo to 10 mg dapagliflozin and metformin, 153 patients were randomised into the saxagliptin added to dapagliflozin plus metformin treatment group, and 162 patients were randomised into the placebo added to dapagliflozin plus metformin treatment group.
Danish: I et randomiseret, dobbeltblindt, placebokontrolleret studie af 24 ugers varighed udført hos patienter med type 2-diabetes mellitus og utilstrækkelig glykæmisk kontrol (HbA1c ≥ 7 % og ≤ 10,5 %) på metformin og dapagliflozin alene blev efterfølgende tillæg af 5 mg saxagliptin til 10 mg dapagliflozin og metformin sammenlignet med tillæg af placebo til 10 mg dapagliflozin og metformin.
English: • Prior to initiation of this medicinal product and at least yearly, thereafter (see sections 4.2, 4.8, 5.1 and 5.2).
Danish: • Før behandlingsstart og mindst én gang årligt derefter (se pkt.
English: It is not recommended for use in patients with severe hepatic impairment (see section 4.4).
Danish: Det frarådes til patienter med svært nedsat leverfunktion (se pkt.
English: This medicinal product is not recommended for use in patients at risk of volume depletion (e.g. receiving loop diuretics) (see section 4.5) or who are volume depleted, e.g. due to acute illness (such as acute gastrointestinal illness with nausea, vomiting or diarrhoea).
Danish: 4.5), eller som er volumendepleterede, fx på grund af akut sygdom (såsom akut gastrointestinal sygdom med kvalme, opkastning eller diarré).
English: What Qtern is and what it is used for What you need to know before you take Qtern How to take Qtern
Danish: Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du begynder at tage Qtern Sådan skal du tage Qtern Bivirkninger
English: - Symptoms of a serious allergic reaction seen rarely, (may affect up to 1 in 1,000 people), which may include: - Rash - Raised red patches on your skin (hives) - Swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.
Danish: Tegnene kan omfatte: - Udslæt - Hævede røde pletter/plamager på huden (nældefeber) - Hævelse af ansigt, læber, tunge og svælg, som kan forårsage vejrtræknings- eller synkebesvær.
English: This may be used to treat fungal infections.
Danish: - Ketoconazol, der anvendes til at behandle svampeinfektioner.
English: How to take Qtern
Danish: Sådan skal du tage Qtern
English: Tel.: +36 1 883 6500
Danish: AstraZeneca Kft. Tel.: +36 1 883 6500
English: - if you have a history of serious heart disease.
Danish: • hvis du har eller tidligere har haft en alvorlig hjertesygdom.
English: F, blood urea increased, weight decreased
Danish: Forhøjet blodkreatinin forhøjet urinstof i blodet, vægttab
English: Saxagliptin/dapagliflozin combination: In the pooled safety analysis, the incidence of adverse events related to decreased renal function was 2.0 % subjects in the saxagliptin plus dapagliflozin plus metformin group, 1.8 % subjects in the saxagliptin plus metformin group, and 0.6 % subjects in the dapagliflozin plus metformin group.
Danish: Saxagliptin/dapagliflozin-kombination: I den puljede sikkerhedsanalyse forekom bivirkninger, relateret til nedsat nyrefunktion, hos 2,0 % af forsøgspersonerne i saxagliptin plus dapagliflozin plus metformin-gruppen, hos 1,8 % af forsøgspersonerne i saxagliptin plus metformin-gruppen og hos 0,6 % af forsøgspersonerne i dapagliflozin plus metformin-gruppen.
English: Placebo + saxagliptin 5 mg + metformin (N=160)
Danish: Placebo + saxagliptin 5 mg + metformin
English: HbA1c irrespective of baseline HbA1c compared with saxagliptin or dapagliflozin alone added to metformin.
Danish: Kombinationen af saxagliptin og dapagliflozin som tillæg til metformin udviste konsekvent større reduktioner i HbA1c uanset baseline-HbA1c i sammenligning med saxagliptin eller dapagliflozin alene som tillæg til metformin.
English: Dyslipidaemia
Danish: Dyslipidæmi
English: Use in patients at risk for volume depletion, hypotension and/or electrolyte imbalances Due to dapagliflozin's mechanism of action, Qtern increases diuresis associated with a modest decrease in blood pressure (see section 5.1), which may be more pronounced in patients with very high blood glucose concentrations.
Danish: På grund af dapagliflozins virkningsmekanisme øger Qtern diuresen, hvilket er forbundet med et moderat blodtryksfald (se pkt.
English: Preferred terms reported in dapagliflozin clinical trials included in order of frequency: rash, rash generalised, rash pruritic, rash macular, rash maculo-papular, rash pustular, rash vesicular, and rash erythematous.
Danish: De foretrukne termer i kliniske studier med dapagliflozin inkluderer efter hyppighed: udslæt, generaliseret udslæt, kløende udslæt, makuløst udslæt, makulopapuløst udslæt, pustuløst udslæt, vesikulært udslæt og erytematøst udslæt.
English: In male and female rats, dapagliflozin showed no effects on fertility at any dose tested.
Danish: Der er ikke påvist virkninger af dapagliflozin på fertiliteten hos han- eller hunrotter ved nogen af de testede doser.
English: Mechanism of action for dapagliflozin
Danish: Virkningsmekanisme for dapagliflozin
English: - if you have or develop nausea (feeling sick), vomiting or fever or if you are not able to eat or drink.
Danish: • hvis du har eller får kvalme, opkastning eller feber, eller hvis du ikke kan spise eller drikke.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Qtern, and during treatment: - if you have “type 1 diabetes” (the type that usually starts when you are young, and your body does not produce any insulin).
Danish: • hvis du har type 1-diabetes (den type diabetes, der normalt starter, når du er ung, og din krop ikke producerer insulin).
English: In patients where DKA is suspected or diagnosed, treatment with Qtern should be discontinued immediately.
Danish: Dapagliflozin skal straks seponeres hos patienter med mistænkt eller verificeret DKA.
English: - Dexamethasone - a steroid medicine.
Danish: - Dexamethason - et steroid, der anvendes til at behandle betændelseslignende tilstande (inflammation) forskellige steder i kroppen.
English: This medicinal product is not recommended for use in patients with severe hepatic impairment (see section 4.2).
Danish: Det frarådes at anvende dette lægemiddel til patienter med risiko for volumendepletering (fx patienter, som får loop-diuretika) (se pkt.
English: Haematocrit increase was observed with dapagliflozin treatment, (see section 4.8); therefore, caution in patients with already elevated haematocrit is warranted.
Danish: Der er blevet observeret forhøjet hæmatokrit i forbindelse med behandling med dapagliflozin (se pkt.
English: vomiting
Danish: Amning
English: Danmark
Danish: Magyarország
English: respectively.
Danish: Lør.
English: pruritus
Danish: Udslæt
English: United Kingdom
Danish: Česká republika
English: If you are not sure, talk to your doctor, pharmacist, or nurse before taking Qtern.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Qtern og under behandlingen:
English: This overview was last updated in November 2018.
Danish: Denne oversigt blev sidst ajourført i november 2018.
English: This will help to protect them against the disease.
Danish: Dette er med til at beskytte dem mod sygdommen.
English: The second injection is given 3 weeks after the first.
Danish: Den anden injektion gives tre uger efter den første.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Danish: Vacciner virker ved at "lære" immunsystemet (kroppens naturlige forsvar), hvordan det skal forsvare sig mod en sygdom.
English: The withdrawal period for meat and milk from sheep and cattle treated with Syvazul BRV is ‘zero' days, which means that there is no mandatory waiting time.
Danish: Tilbageholdelsestiden for kød og mælk fra får og kvæg, der behandles med Syvazul BRV, er "nul" dage, hvilket vil sige, at der ikke er nogen påkrævet ventetid.
English: Further information on Syvazul BTV can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/syvazul-btv.
Danish: Yderligere information om Syvazul BTV findes på agenturets websted under: ema.europa.eu/medicines/veterinary/EPAR/syvazul-btv.
English: The vaccine is given as a single injection under the skin to sheep from 3 months of age.
Danish: Vaccinen gives som en enkelt injektion under huden til får fra 3-måneders alderen.
English: Revaccination is required after 1 year.
Danish: Revaccination er nødvendig efter ét år.
English: In the future, if the animals are exposed to the bluetongue virus, their immune system will be able to produce antibodies more quickly.
Danish: Hvis dyrene fremover udsættes for bluetonguevirus, vil deres immunsystem kunne producere antistoffer hurtigere.
English: People who are hypersensitive (allergic) to aluminium hydroxide, thiomersal or saponins should avoid contact with Syvazul BTV.
Danish: Personer, der er overfølsomme (allergiske) over for aluminiumhydroxid, thiomersal eller saponiner, bør undgå kontakt med Syvazul BTV.
English: Syvazul BTV is a vaccine.
Danish: Syvazul BTV er en vaccine.
English: Revaccination with one injection is required after 1 year.
Danish: Revaccination med én indsprøjtning er nødvendig efter ét år.
English: The vaccine also contains ‘adjuvants' (aluminium hydroxide and saponin) that enhance the response of the immune system.
Danish: Vaccinen indeholder også "adjuvanser" (aluminiumhydroxid og saponin), som giver en bedre immunrespons.
English: The European Medicines Agency decided that Syvazul BTV's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur besluttede, at fordelene ved Syvazul BTV opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: The main measure of effectiveness was the presence of virus in the blood and the studies have shown that the vaccine is effective in producing protective antibodies in sheep and cattle.
Danish: Virkningen blev hovedsagelig målt på forekomsten af virus i blodet, og undersøgelserne har vist, at vaccinen er effektiv til at producere beskyttende antistoffer hos får og kvæg.
English: The most common side effects with Syvazul BTV (which may affect more than 1 in 10 animals) are local injection site reactions, erythema (reddening of the skin) with mild to moderate swelling 1 to 6 days after vaccination, a painless nodule (up to 3.8 cm diameter in sheep and 7 cm diameter in cattle) 2 to 6 days after vaccination and a short-lived increase in body temperature of no more than 2.3˚C in the 48 hours after vaccination.
Danish: De hyppigste bivirkninger ved Syvazul BTV (som kan optræde hos mere end 1 ud af 10 dyr) er lokale reaktioner på injektionsstedet, erytem (rødmen af huden) med mild til moderat hævelse 1 til 6 dage efter vaccination, en smertefri knude (op til 3,8 cm i diameter hos får og 7 cm i diameter hos kvæg) 2 til 6 dage efter vaccinationen og en kortvarig stigning i kropstemperaturen på højst 2,3 °C i 48 timer efter vaccinationen.
English: The vaccine contains inactivated (killed) bluetongue viruses.
Danish: Vaccinen indeholder inaktiverede (dræbte) bluetonguevira.
English: Other information about Syvazul BTV
Danish: Andre oplysninger om Syvazul BTV
English: When it is given to sheep and cattle, the animals' immune systems recognise the viruses as ‘foreign' and make antibodies against them.
Danish: Når kvæg og får vaccineres, registrerer dyrenes immunsystem viraene som "fremmede" og reagerer ved at danne antistoffer imod dem.
English: Syvazul BTV contains bluetongue viruses that have been inactivated so that they cannot cause the disease.
Danish: Syvazul BTV indeholder bluetonguevira, der er blevet inaktiveret, så de ikke kan fremkalde sygdommen.
English: The vaccine is available as an injection and can only be obtained with a prescription.
Danish: Vaccinen fås som injektionsvæske og udleveres kun efter recept.
English: Syvazul BTV is a vaccine used in sheep and cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges.
Danish: Syvazul BTV er en vaccine, der anvendes til får og kvæg for at beskytte dem mod sygdommen bluetongue, en infektion forårsaget af bluetonguevirus, som overføres gennem mitter.
English: For more information about using Syvazul BTV, see the package leaflet or contact your veterinarian or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelsen af Syvazul BTV, kan du læse indlægssedlen eller kontakte din dyrlæge eller apoteket.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Syvazul BTV, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Danish: Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Syvazul BTV, herunder passende forholdsregler, som skal følges af sundhedspersoner og den, der er ejer af eller ansvarlig for dyret.
English: An overview of Syvazul BTV and why it is authorised in the EU
Danish: Oversigt over Syvazul BTV, og hvorfor det er godkendt i EU
English: The vaccine is given as two injections into a muscle to calves from 2 months of age if the calves have no immunity to bluetongue virus or from 3 months of age in calves born to mothers already immune to the disease.
Danish: Vaccinen gives som to injektioner til kalve fra 2-måneders alderen, hvis kalvene ikke har nogen immunitet over for bluetonguevirus, eller fra 3-måneders alderen hos kalve, hvis mødre allerede er immune over for sygdommen.
English: For the full list of side effects and restrictions of Syvazul BTV, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Syvazul BTV fremgår af indlægssedlen.
English: Laboratory studies were conducted in which sheep and cattle vaccinated with Syvazul BTV were exposed to BTV serotype 1, 4 or 8.
Danish: Der blev gennemført laboratorieundersøgelser, hvor får og kvæg, der var vaccineret med Syvazul BTV, blev eksponeret for bluetonguevirusserotype 1, 4 eller 8.
English: Syvazul BTV contains bluetongue virus of one or two types selected from serotypes 1, 4 and 8.
Danish: Syvazul BTV indeholder bluetonguevirus af en eller to typer udvalgt fra serotyperne 1, 4 og 8.
English: No field studies were provided with BTV-4 in sheep or cattle, however, the laboratory studies were considered sufficient to show effectiveness of the BTV-4 vaccine.
Danish: Der blev ikke fremlagt feltundersøgelser med bluetonguevirus 4 hos får eller kvæg, men laboratorieundersøgelserne blev anset for at være tilstrækkelige til at påvise bluetonguevirus 4vaccinens effektivitet.
English: What is Syvazul BTV and what is it used for?
Danish: Hvad er Syvazul BTV, og hvad anvendes det til?
English: Syvazul BTV received a marketing authorisation valid throughout the EU on 9 January 2019.
Danish: Syvazul BTV modtog en markedsføringstilladelse med gyldighed i hele Den Europæiske Union den
English: What are the risks associated with Syvazul BTV?
Danish: Hvilke risici er der forbundet med Syvazul BTV?
English: Why is Syvazul BTV authorised in the EU?
Danish: Hvorfor blev Syvazul BRV godkendt i EU?
English: In a field study, 3 groups of 35 lambs from 3 months of age (with no antibodies to bluetongue virus) received vaccination with vaccines containing BTV-1, BTV-8 and BTV 1+8.
Danish: I et feltstudie blev tre grupper af 35 lam fra 3måneders alderen (uden antistoffer mod bluetonguevirus) vaccineret med vacciner indeholdende bluetonguevirus 1, bluetonguevirus 8 og bluetonguevirus 1+8.
English: Effectiveness was measured by comparing antibody levels at 21 and 42 days after completing the initial vaccination course with levels from laboratory studies.
Danish: Virkningen blev målt ved at sammenligne antistofniveauerne på dag 21 og 42 efter afslutningen af det indledende vaccinationsforløb med niveauer fra laboratorieundersøgelser.
English: Effectiveness was measured by comparing antibody levels to the virus at days 35 and 63 after vaccination with levels from laboratory studies.
Danish: Virkningen blev målt ved at sammenligne antistofniveauerne for virusset på dag 35 og 63 efter vaccination med niveauer fra laboratorieundersøgelser.
English: Groups of 25 calves from 2 months of age (with no antibodies to bluetongue virus) were vaccinated with vaccines containing BTV-1, BTV-8 and BTV 1+8 in a field study.
Danish: Grupper af 25 kalve over 2måneders alderen (uden antistoffer mod bluetonguevirus) blev vaccineret med vacciner indeholdende bluetonguevirus 1, bluetonguevirus 8 og bluetonguevirus 1+8 i en feltundersøgelse.
English: How is Syvazul BTV used?
Danish: Hvordan anvendes Syvazul BTV?
English: The data showed that antibody levels at day 42 after vaccination for each group remained at levels similar to day 21 after vaccination and above levels from the laboratory studies.
Danish: Dataene viste, at antistofniveauet på dag 42 efter vaccination hos hver gruppe lå på samme niveau som på dag 21 efter vaccination og over niveauet fra laboratorieundersøgelserne.
English: The data showed that antibody levels at day 63 after vaccination for each group remained at levels similar to day 35 after vaccination and above levels from the laboratory studies.
Danish: Dataene viste, at antistofniveauet på dag 63 efter vaccination hos hver gruppe lå på samme niveau som på dag 35 efter vaccination og over niveauet fra laboratorieundersøgelserne.
English: Laboratory studies showed that in cattle the vaccine starts to be effective 21 days after completion of the initial vaccination course and protection lasts one year.
Danish: Laboratorieundersøgelserne viste, at hos kvæg begyndte vaccinerne at virke 21 dage efter afslutningen af det indledende vaccinationsforløb, og at beskyttelsen varer ét år.
English: The vaccine starts to be effective 21 days after completion of the initial vaccination course and protection lasts one year.
Danish: Vaccinen begynder at virke 21 dage efter, at det oprindelige vaccinationsforløb er afsluttet, og beskyttelsen varer ét år.
English: The variety (serotype) of the virus in the vaccine is selected depending on which serotypes are circulating and causing disease at the time of manufacture, so it may contain serotype 1, 4 or 8 or a combination of any two of these.
Danish: Virusarten (serotypen) i vaccinen udvælges afhængigt af, hvilke serotyper der cirkulerer og forårsager sygdommen på fremstillingstidspunktet.
English: The vaccine starts to be effective 39 days after vaccination and protection lasts for 1 year.
Danish: Vaccinen begynder at virke 39 dage efter vaccinationen, og beskyttelsen varer i ét år.
English: What benefits of Syvazul BTV have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Syvazul BTV?