FrancophonIA/ELRC3.0 huggingface dataset:
English: The study involved patients with type 2 diabetes who already had cardiovascular disease (such as angina, heart attack and stroke).
Danish: Undersøgelsen omfattede patienter med type 2-diabetes, som allerede led af hjerte-kar-sygdomme (såsom angina, hjerteanfald eller slagtilfælde).
English: It contains the active substances empagliflozin and metformin.
Danish: Det indeholder de aktive stoffer, empagliflozin og metformin.
English: The main measure of effectiveness was the occurrence of one of three major cardiovascular events: stroke, heart attack or death caused by cardiovascular disease.
Danish: Virkningen blev hovedsageligt bedømt på forekomsten af én af tre alvorlige hjerte-karhændelser: slagtilfælde, hjerteanfald eller dødsfald forårsaget af hjerte-kar-sygdom.
English: Metformin works mainly by reducing the production of glucose in the body and reducing its absorption from the gut.
Danish: Metformin virker hovedsageligt ved sænke produktionen af glukose i kroppen og mindske dets optagelse fra tarmene.
English: The benefits of empagliflozin in combination with metformin have been shown in 3 main studies involving 1,679 patients with type 2 diabetes whose blood sugar was not adequately controlled by metformin, alone or combined with other diabetes medicines (such as pioglitazone or a type of diabetes medicine called a sulphonylurea).
Danish: Fordelene ved empagliflozin i kombination med metformin er påvist i tre hovedundersøgelser hos 1 679 patienter med type 2-sukkersyge, hvis blodsukker ikke kunne reguleres tilfredsstillende med metformin alene eller i kombination med andre lægemidler mod sukkersyge (såsom pioglitazon eller sulfonylurinstoffer).
English: • severely reduced kidney function or conditions that could affect the kidneys such as dehydration, severe infection or a steep fall in blood pressure;
Danish: • svært nedsat nyrefunktion eller tilstande, der kan påvirke nyrerne såsom dehydrering, svær infektion eller et brat fald i blodtrykket
English: For more information about treatment with Synjardy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Synjardy, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: • in combination with other diabetes medicines in patients whose diabetes is not sufficiently controlled on these medicines plus metformin;
Danish: • i kombination med andre lægemidler mod diabetes hos patienter, hvis diabetes ikke reguleres tilstrækkeligt med disse lægemidler plus metformin
English: In those receiving empagliflozin, cardiovascular events occurred in 10.5% (490 out of 4,687) of patients compared with 12.1% (282 out of 2,333) of patients receiving placebo.
Danish: Der opstod hjerte-kar-hændelser hos 10,5 % (490 ud af 4 687) af de patienter, der fik empagliflozin, sammenholdt med 12,1 % (282 ud af 2 333) af dem, der fik placebo.
English: The CHMP concluded that the medicine could help produce a clinically meaningful reduction in blood glucose in patients with type 2 diabetes, and the benefits and risks were in line with those of the individual active substances.
Danish: CHMP konkluderede, at lægemidlet kunne give en klinisk betydningsfuld reduktion i indholdet af glukose i blodet hos patienter med type 2-sukkersyge, og at fordelene og risiciene var de samme som ved hvert aktive stof for sig.
English: Empagliflozin works by blocking a protein in the kidneys (called sodium-glucose co-transporter 2 or SGLT2).
Danish: Empagliflozin virker ved at blokere et protein i nyrerne (kaldet natrium-glukose-kotransporter 2 (SGLT2)).
English: • in patients whose diabetes is not sufficiently controlled by metformin alone;
Danish: • hos patienter, hvis diabetes ikke reguleres tilstrækkeligt med metformin
English: Overall, the additional reduction was 0.58 percentage points with a combination providing 5 mg of empagliflozin twice daily, and 0.62 percentage points with the 12.5 mg dose, and these reductions were considered clinically relevant.
Danish: Overordnet udgjorde den yderligere reduktion 0,58 procentpoint ved brug af kombinationen med 5 mg empagliflozin to gange dagligt, og 0,62 procentpoint med 12,5 mg.
English: The most common side effects with Synjardy are hypoglycaemia (low blood sugar levels) when the medicine is taken with a sulphonylurea or insulin, infections of the urinary tract and genitals, and increased urination.
Danish: De hyppigste bivirkninger ved Synjardy er hypoglykæmi (lavt blodsukker), når lægemidlet tages sammen med et sulfonylurinstof eller insulin, infektioner i urinvejene eller kønsdelene og øget vandladning.
English: If Synjardy is used in combination with insulin or a sulphonylurea (a medicine that increases the body's production of insulin), the doses of these medicines may need to be lowered to avoid hypoglycaemia (low blood sugar levels).
Danish: Hvis Synjardy bruges sammen med insulin eller sulfonylurinstoffer (lægemidler, der øger insulinproduktionen), kan det være nødvendigt at nedsætte dosis af disse lægemidler for at undgå for lavt blodsukker (hypoglykæmi).
English: Another main study showed that adding empagliflozin (one of the active substances of Synjardy) to usual treatment reduced adverse cardiovascular (heart and blood vessels) effects.
Danish: En anden hovedundersøgelse viste, at tilføjelse af empagliflozin (et af de aktive stoffer i Synjardy) til den sædvanlige behandling gav færre hjerte-kar-bivirkninger.
English: In type 2 diabetes the body does not make enough insulin to control the level of glucose (sugar) in the blood or the body is unable to use insulin effectively.
Danish: Ved type 2-diabetes er kroppen ikke i stand enten til at producere nok insulin til at regulere indholdet af glukose i blodet (blodsukkeret) eller til at udnytte insulin effektivt.
English: The two active substances in Synjardy, empagliflozin and metformin, work in different ways to lower blood glucose, and thus to control symptoms of the disease.
Danish: De to aktive stoffer i Synjardy, empagliflozin og metformin, medvirker på forskellig vis til at sænke indholdet af glukose i blodet og dermed til at kontrollere sygdomssymptomerne.
English: • a condition that could reduce the supply of oxygen to body tissues (such as in patients with worsening heart failure, recent heart attack, breathing difficulty or a steep fall in blood pressure);
Danish: • en tilstand, der kan medføre nedsat ilttilførsel til kroppens væv (f.eks. hos patienter, der har forværret hjerteinsufficiens, der for nylig har haft et hjerteanfald, der har åndedrætsbesvær, eller som oplever et brat fald i blodtrykket
English: Studies also indicated Synjardy was as effective as empagliflozin and metformin taken separately, and that the combination helped reduce HbA1c when added to treatment including insulin.
Danish: Undersøgelserne viste desuden, at Synjardy var lige så effektivt som empagliflozin og metformin taget hver for sig, og at kombinationen nedsatte HbA1c som tillægsbehandling også til insulin.
English: Synjardy was also shown to reduce cardiovascular events in patients with type 2 diabetes who already had cardiovascular disease.
Danish: Synjardy viste sig desuden at reducere hjerte-kar-hændelser hos patienter med type 2-diabetes og allerede eksisterende hjerte-kar-sygdom.
English: Synjardy is available as tablets containing 5 or 12.5 mg of empagliflozin with 850 or 1,000 mg of metformin, and can only be obtained with a prescription.
Danish: Synjardy fås som tabletter indeholdende 5 mg eller 12,5 mg empagliflozin med 850 mg eller 1 000 mg metformin.
English: For practical information about using Synjardy, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Synjardy, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The studies showed a greater reduction in HbA1c when empagliflozin plus metformin was given, compared with placebo plus metformin.
Danish: Undersøgelserne viste en større reduktion i HbA1c med empagliflozin plus metformin end med placebo plus metformin.
English: For the full list of all side effects reported with Synjardy, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Synjardy fremgår af indlægssedlen.
English: How is Synjardy used?
Danish: Hvordan anvendes Synjardy?
English: The studies compared the effect of empagliflozin plus metformin versus placebo (a dummy treatment) with metformin.
Danish: I undersøgelserne blev virkningen af empagliflozin plus metformin sammenlignet med virkningsløs medicin (placebo) med metformin.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Synjardy 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 Synjardy.
English: In addition, the results indicated that the combination was associated with a beneficial decrease in body weight and blood pressure.
Danish: Kombinationen medførte desuden vægttab og sænkede blodtrykket til gavn for patienterne.
English: How does Synjardy work?
Danish: Hvordan virker Synjardy?
English: What benefits of Synjardy have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Synjardy?
English: Some of these were continuations of the main studies that suggested the benefits of the combination continued with longer therapy.
Danish: De viste, at fordelene ved kombinationen holdt sig ved længere tids behandling.
English: By blocking the action of SGLT2, empagliflozin causes more glucose to be removed in the urine, thereby reducing the levels of glucose in the blood.
Danish: Empagliflozin blokerer virkningen af SGLT2 og bevirker derved, at der udskilles mere sukker gennem urinen, så indholdet af sukker i blodet falder.
English: It should be used in combination with safer sex practices, such as use of condoms.
Danish: Det bør anvendes i kombination med sikrere sex, hvor der f.eks. anvendes kondomer.
English: Emtricitabine/Tenofovir disoproxil Zentiva received a marketing authorisation valid throughout the EU on 9 November 2016.
Danish: Emtricitabine/Tenofovir disoproxil Zentiva fik en markedsføringstilladelse med gyldighed i hele EU den 9. november 2016.
English: The company also carried out a study that showed that it is ‘bioequivalent' to the reference medicine.
Danish: Virksomheden gennemførte også et studie, der viste, at lægemidlet er "bioækvivalent" med referencelægemidlet.
English: In addition it may be used from the age of 12 years in adolescents with HIV that is resistant to first-line treatments or who cannot take them because of side effects.
Danish: Desuden kan det anvendes fra 12-årsalderen hos unge med hiv, som er resistente over for førstevalgsbehandlinger, eller som ikke kan få disse på grund af bivirkninger.
English: Further information on Emtricitabine/Tenofovir disoproxil Zentiva can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/emtricitabinetenofovir-disoproxil-zentiva.
Danish: Yderligere information vedrørende Emtricitabine/Tenofovir disoproxil Zentiva findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/emtricitabinetenofovir-disoproxil-zentiva.
English: Studies on the benefits and risks of the active substances in the authorised uses have already been carried out with the reference medicine, Truvada, and do not need to be repeated for Emtricitabine/Tenofovir disoproxil Zentiva.
Danish: Der er allerede foretaget studier af de aktive stoffers fordele og risici ved godkendt brug med referencelægemidlet, Truvada, og de behøver ikke blive gentaget for Emtricitabine/Tenofovir disoproxil Zentiva.
English: Side effects reported with Emtricitabine/Tenofovir disoproxil Zentiva are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Emtricitabine/Tenofovir disoproxil Zentiva vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Emtricitabine/Tenofovir disoproxil Zentiva does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Emtricitabine/Tenofovir disoproxil Zentiva helbreder ikke hivinfektion eller aids, men kan udsætte den skade på immunsystemet og de infektioner og sygdomme, der er forbundet med aids.
English: Both emtricitabine and tenofovir work in similar ways by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses.
Danish: Emtricitabin og tenofovir virker begge ved at blokere revers transkriptase, et enzym frembragt af hiv, der gør det muligt for virusset at smitte celler og producere flere virusser.
English: If patients with HIV1 infection need to stop taking emtricitabine or tenofovir, or need to take different doses, they will need to take medicines containing emtricitabine or tenofovir disoproxil separately.
Danish: Hvis patienter med hiv-infektion-1 skal holde op med at tage emtricitabin eller tenofovir eller skal have ændret dosis, skal de tage medicin indeholdende emtricitabin eller tenofovirdisoproxil hver for sig.
English: Because Emtricitabine/Tenofovir disoproxil Zentiva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Emtricitabine/Tenofovir disoproxil Zentiva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Emtricitabine/Tenofovir disoproxil Zentiva contains two active substances, emtricitabine (200 mg) and tenofovir disoproxil (245 mg).
Danish: Emtricitabine/Tenofovir disoproxil Zentiva indeholder to aktive stoffer, emtricitabin (200 mg) og tenofovirdisoproxil (245 mg).
English: Healthcare professionals will also receive a brochure and reminder card to hand out to individuals receiving the medicine for pre-exposure prophylaxis.
Danish: Sundhedspersoner vil også modtage en brochure og et huskekort til uddeling til personer, der tager lægemidlet som profylakse før eksponering.
English: Emtricitabine/Tenofovir disoproxil Zentiva is also used to help prevent sexually transmitted HIV-1 infection in adults and adolescents who are at high risk of being infected (pre-exposure prophylaxis or PrEP).
Danish: Emtricitabine/Tenofovir disoproxil Zentiva anvendes også til forebyggelse af seksuelt overført hiv-1infektion hos voksne og unge, som har høj risiko for at blive smittet (profylakse før eksponering eller PrEP).
English: For more information about using Emtricitabine/Tenofovir disoproxil Zentiva, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Emtricitabine/Tenofovir disoproxil Zentiva, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: Emtricitabine/Tenofovir disoproxil Zentiva can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing HIV infection.
Danish: Emtricitabine/Tenofovir disoproxil Zentiva fås kun på recept, og behandlingen bør indledes af en læge med erfaring i behandling af hivinfektioner.
English: The company that markets Emtricitabine/Tenofovir disoproxil Zentiva will provide an information pack to doctors, which covers the potential harmful effects of Emtricitabine/Tenofovir disoproxil Zentiva on kidney function, and information about use in adults for pre-exposure prophylaxis.
Danish: Virksomheden, der markedsfører Emtricitabine/Tenofovir disoproxil Zentiva, vil forsyne lægerne med en informationspakke, som omhandler de mulige skadelige virkninger af Emtricitabine/Tenofovir disoproxil Zentiva på nyrefunktionen samt information om brug hos voksne i forbindelse med profylakse før eksponering.
English: Therefore, the Agency's view was that, as for Truvada, the benefits of Emtricitabine/Tenofovir disoproxil Zentiva outweigh the identified risks and it can be authorised for use in the EU.
Danish: Det var derfor agenturets opfattelse, at fordelene ved Emtricitabine/Tenofovir disoproxil Zentiva opvejer de identificerede risici, som for Truvada, og at det kan godkendes til anvendelse i EU.
English: Emtricitabine/Tenofovir disoproxil Zentiva is used in combination with at least one other HIV medicine to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Emtricitabine/Tenofovir disoproxil Zentiva anvendes sammen med mindst ét andet hiv-lægemiddel til behandling af voksne, som er smittet med humant immundefektvirus type 1 (hiv-1, et virus, som forårsager erhvervet immundefektsyndrom (aids)).
English: Tenofovir is a nucleotide reverse transcriptase inhibitor.
Danish: Tenofovir er en nukleotidrevers transkriptasehæmmer.
English: As for every medicine, the company provided studies on the quality of Emtricitabine/Tenofovir disoproxil Zentiva.
Danish: Som for alle lægemidler fremlagde virksomheden undersøgelser af kvaliteten af Emtricitabine/Tenofovir disoproxil Zentiva.
English: As for all medicines, data on the use of Emtricitabine/Tenofovir disoproxil Zentiva are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Emtricitabine/Tenofovir disoproxil Zentiva løbende overvåget.
English: An overview of Emtricitabine/Tenofovir disoproxil Zentiva and why it is authorised in the EU
Danish: Oversigt over Emtricitabine/Tenofovir disoproxil Zentiva, og hvorfor det er godkendt i EU
English: For pre-exposure prophylaxis of HIV-1 infection, it is expected that Emtricitabine/Tenofovir disoproxil Zentiva in the blood will stop the virus from multiplying and spreading from the site of infection in case the individual is exposed to the virus.
Danish: Ved profylakse før eksponering for hiv-1-infektion forventes Emtricitabine/Tenofovir disoproxil Zentiva i blodet at forhindre virusset i at formere og sprede sig fra infektionsstedet, hvis personen eksponeres for virusset.
English: This means that Emtricitabine/Tenofovir disoproxil Zentiva contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Truvada.
Danish: Det betyder, at Emtricitabine/Tenofovir disoproxil Zentiva er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Truvada.
English: Emtricitabine/Tenofovir disoproxil Zentiva contains two active substances: emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘prodrug' of tenofovir.
Danish: Emtricitabine/Tenofovir disoproxil Zentiva indeholder to aktive stoffer: emtricitabin, der er en nukleosidrevers transkriptasehæmmer, og tenofovirdisoproxil, der er et "prodrug" til tenofovir.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Emtricitabine/Tenofovir disoproxil Zentiva has been shown to have comparable quality and to be bioequivalent to Truvada.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at Emtricitabine/Tenofovir disoproxil Zentiva er påvist at være af samme kvalitet som Truvada og er bioækvivalent med dette i overensstemmelse med EU-reglerne.
English: Other information about Emtricitabine/Tenofovir disoproxil Zentiva
Danish: Andre oplysninger om Emtricitabine/Tenofovir disoproxil Zentiva
English: Emtricitabine/Tenofovir disoproxil Zentiva (emtricitabine / tenofovir disoproxil)
Danish: Emtricitabine/Tenofovir disoproxil Zentiva (emtricitabin/tenofovirdisoproxil)
English: What measures are being taken to ensure the safe and effective use of Emtricitabine/Tenofovir disoproxil Zentiva?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Emtricitabine/Tenofovir disoproxil Zentiva?
English: Emtricitabine/Tenofovir disoproxil Zentiva is available as tablets.
Danish: Emtricitabine/Tenofovir disoproxil Zentiva findes som tabletter.
English: What is Emtricitabine/Tenofovir disoproxil Zentiva and what is it used for?
Danish: Hvad er Emtricitabine/Tenofovir disoproxil Zentiva, og hvad anvendes det til?
English: What are the benefits and risks of Emtricitabine/Tenofovir disoproxil Zentiva?
Danish: Hvilke fordele og risici er der forbundet med Emtricitabine/Tenofovir disoproxil Zentiva?
English: Both active substances have been authorised in the EU since the early 2000s: emtricitabine was authorised as Emtriva in 2003, and tenofovir disoproxil was authorised as Viread in 2002.
Danish: Begge aktive stoffer har været godkendt i Den Europæiske Union (EU) siden årene efter 2000.
English: Why is Emtricitabine/Tenofovir disoproxil Zentiva authorised in the EU?
Danish: Hvorfor er Emtricitabine/Tenofovir disoproxil Zentiva godkendt i EU?
English: For the treatment of HIV-1 infection, Emtricitabine/Tenofovir disoproxil Zentiva, taken in combination with at least one other HIV medicine, reduces the amount of HIV in the blood and keeps it at a low level.
Danish: Ved behandling af hiv-1-infektion nedsætter Emtricitabine/Tenofovir disoproxil Zentiva hivmængden i blodet og holder den nede, når det anvendes i kombination med mindst ét andet antiviralt lægemiddel.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Emtricitabine/Tenofovir disoproxil Zentiva have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Emtricitabine/Tenofovir disoproxil Zentiva.
English: How has Emtricitabine/Tenofovir disoproxil Zentiva been studied?
Danish: Hvordan blev Emtricitabine/Tenofovir disoproxil Zentiva undersøgt?
English: How is Emtricitabine/Tenofovir disoproxil Zentiva used?
Danish: Hvordan anvendes Emtricitabine/Tenofovir disoproxil Zentiva?
English: How does Emtricitabine/Tenofovir disoproxil Zentiva work?
Danish: Hvordan virker Emtricitabine/Tenofovir disoproxil Zentiva?
English: SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Danish: PRODUKTRESUME, ETIKETTERING OG INDLÆGSSEDDEL
English: 1 Previously known as Nymusa.
Danish: 1 Tidligere kendt som Nymusa.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nymusa on 02 July 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Nymusa den 2. juli 2009.
English: The name of the medicine was changed to Peyona on 24 November 2010.
Danish: Navnet blev ændret til Peyona den 24. november 2010.
English: Primary means that the apnoea has no obvious cause.
Danish: Primær betyder, at apnøen ikke har nogen indlysende årsag.
English: This is a summary of the European public assessment report (EPAR) for Peyona.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Peyona.
English: The solution can also be given by mouth.
Danish: Opløsningen kan også indgives oralt.
English: This study looked at how long the babies survived and whether or not they had neurological disabilities after 18 months.
Danish: I denne undersøgelse så man på, hvor længe børnene overlevede, og på, om de havde nogen neurologiske lidelser efter 18 måneder.
English: Other information about Peyona
Danish: Andre oplysninger om Peyona
English: A risk management plan has been developed to ensure that Peyona is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Peyona anvendes så sikkert som muligt.
English: This reduces the effect of adenosine, stimulating the brain to resume breathing.
Danish: Dette nedbringer virkningen af adenosin og stimulerer hjernen til at genoptage vejrtrækningen.