FrancophonIA/ELRC3.0 huggingface dataset:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 July 1996.
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: 1 ml of suspension in a vial (type I glass) for 2 doses with a plunger stopper (rubber butyl) - pack size of
Danish: 1 ml suspension i hætteglas (type I glas) til 2 doser, med en propstopper (butylgummi)
English: 3 Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology
Danish: 3produceret på gærceller (Saccharomyces cerevisiae) ved recombinant DNA teknologi
English: Tritanrix HepB, suspension for injection
Danish: Tritanrix HepB, suspension til injektion
English: Tritanrix HepB, suspension for injection, multidose
Danish: Tritanrix HepB, suspension, injektion, flerdosis
English: Diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)
Danish: Difteria (D), tetanus (T), pertussis (helcelle) (Pw) og hepatitis B (rDNA) (HBV) vaccine (adsorberet)
English: The administration of Tritanrix HepB should be postponed in subjects suffering from acute severe
Danish: Som for andre vacciner bør indgift af Tritanrix HepB udsættes hos personer, der lider af akut alvorlig
English: Thiomersal
Danish: DTPw
English: PHARMACEUTICAL PARTICULARS
Danish: BIVIRKNINGER
English: This HBsAg expressed in yeast cells is purified by several physico-chemical steps.
Danish: Dette HBsAg udtrykt i gærceller er oprenset ved flere fysisk-kemiske trin. HBsAg´et samles spontant uden kemisk behandling til sfæriske partikler med en gennemsnitlig diameter på 20 nm.
English: - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
Danish: - Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du bemærker bivirkninger,
English: Tritanrix HepB suspension for injection, multidose Diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)
Danish: Tritanrix HepB injektion, suspension, flerdosis Difteria (D), tetanus (T), pertussis (helcelle) (Pw) og hepatitis B (rDNA) (HBV) vaccine (adsorberet)
English: ♦ Uncommon (side effects which may occur in less than 1 per 100 but more than 1 per 1,000 doses of
Danish: ♦ Ikke almindelig (bivirkninger som optræder ved mindre en 1 ud af 100 doser af vaccinen, men
English: Tritanrix HepB suspension for injection Diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)
Danish: Tritanrix HepB injektion, suspension Difteria (D), tetanus (T), pertussis (helcelle) (Pw) og hepatitis B (rDNA) (HBV) vaccine (adsorberet)
English: ♦ Common (side effects which may occur in less than 1 per 10 but more than 1 per 100 doses of
Danish: ♦ Almindelig (bivirkninger som optræder ved mindre en 1 ud af 10 doser af vaccinen, men ved
English: 0.37 milligrams Al3+
Danish: 0,37 milligram Al3+
English: 0.26 milligrams Al3+
Danish: 0,26 milligram Al3+
English: Lietuva GlaxoSmithKline Lietuva UAB
Danish: Malta GlaxoSmithKline Malta
English: Tel: + 44 (0)808 100 9997 customercontactuk@gsk.com
Danish: GlaxoSmithKline UK Tel: + 44 (0)808 100 9997 customercontactuk@gsk.com
English: I.M.
Danish: KG
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
Danish: Emballage og eventuelt ikke anvendt lægemiddel tilbageleveres til apotek/leverandør eller kommunal
English: 6.1 List of excipients
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Hjælpestoffer Thiomersal
English: 1 Adsorbed on aluminium hydroxide, hydrated
Danish: - Øvrige indholdstoffer: thiomersal, natriumklorid og vand til injektion.
English: Deutschland
Danish: United Kingdom
English: What Tritanrix HepB looks like and contents of the pack
Danish: TRITANRIX HepBS VIRKNING OG HVAD DU SKAL BRUGE DET TIL
English: ∗ Notes: the information given in this document and its annexes reflects only the CHMP opinion dated 26 June 2008.
Danish: * Bemærkninger: Oplysningerne i dette dokument og bilagene afspejler udelukkende CHMP's udtalelse af 23. juni 2005.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, the amended product information in Annex III and the conditions of the marketing authorisation in Annex IV.
Danish: Listen over de pågældende lægemiddelnavne fremgår af bilag I. De faglige konklusioner findes i bilag II og det ændrede produktresumé i bilag III.
English: London, 23 October 2008 EMEA/542169/2008
Danish: 28. november 2005 EMEA/CHMP/383082/2005
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 31(2) REFERRAL Etoricoxib containing medicinal products International non-proprietary name (INN): etoricoxib BACKGROUND INFORMATION *
Danish: Internationalt fællesnavn ( INN): ETORICOXIB
English: Written explanations were provided by the MAHs on 14 December 2008, 5 May 2008, 12 June 2008 and 20 June 2008.
Danish: Indehaveren af markedsføringstilladelsen for etoricoxib fremsendte skriftlige redegørelser den 10. januar og den 10. maj 2005.
English: The final opinion was converted into a decision by the European Commission on 9 September 2008.
Danish: Europa-Kommissionen traf en afgørelse den 28. november 2005 på grundlag af CHMP's udtalelse.
English: As these concerns were not resolved during the course of the procedure, and since the 90mg dose of etoricoxib was used in both RA and AS, a notification of an official referral for arbitration under Article 31(2) of Directive 2001/83, as amended to the CHMP was made by France on 19 September 2007.
Danish: CHMP udvidede derfor, den 20. april 2005 efter anmodning fra Europa-Kommissionen og i henhold til artikel 31 i direktiv 2001/83/EF, med senere ændringer, og gennemgangen af CHMP i henhold til artikel 18 i Rådets forordning (EF) nr. 2309/93, formålet med proceduren til ud over de kardiovaskulære sikkerhedsaspekter også at omfatte vurderingen af oplysninger om alvorlige hudreaktioner.
English: France considered that a review of the benefit/risk profile of etoricoxib containing medicinal products was of Community interest.
Danish: Heri anbefalede CHMP at opretholde markedsføringstilladelserne for lægemidler indeholdende etoricoxib for indikationerne i produktresuméet, jf. bilag III.
English: Etoricoxib is a selective inhibitor of COX-2 (cyclooxygenase 2) indicated in the symptomatic relief of osteoarthritis (OA, 30-60mg once daily (od)), rheumatoid arthritis (RA, 90mg od) and the pain and signs of inflammation associated with acute gouty arthritis (120mg od).
Danish: COX-2 hæmmerne celecoxib, etoricoxib, lumiracoxib, parecoxib, rofecoxib og valdecoxib udgør en forholdsvis ny gruppe stoffer, hvis fælles farmakologiske virkning er selektiv hæmning af cyclooxygenase-2.
English: There was little direct comparative safety data for individual non-steroidal anti-inflammatory drugs (NSAIDs) other than diclofenac and naproxen.
Danish: COX-2-hæmmere er blevet indført i klinisk praksis til behandling af patienter med kroniske inflammatoriske degenerative sygdomme som reumatoid arthritis og osteoartrose.
English: It was therefore difficult to determine risks for etoricoxib compared with ibuprofen, ketoprofen or other less-commonly used NSAIDs.
Danish: FOR SAMTLIGE LÆGEMIDLER INDEHOLDENDE CELECOXIB, ETORICOXIB, LUMIRACOXIB, PARECOXIB OG VALDECOXIB
English: The CHMP concluded that the data confirmed the known renovascular safety profile of etoricoxib (hypertension, oedema and congestive heart failure).
Danish: I september 2004 underrettede indehaveren af markedsføringstilladelsen for rofecoxib EMEA om, at oplysninger fra en ny klinisk undersøgelse (APPROVe) af rofecoxib havde vist risiko for thrombotiske kardiovaskulære hændelser.
English: On 26 June 2008, the CHMP, having considered the data provided by the MAHs, recommended the granting of the variation to the marketing authorisations.
Danish: Den 18. november 2004 anmodede CHMP om omfattende oplysninger vedrørende den kardiovaskulære sikkerhed ved disse lægemidler.
English: The referral procedure was initiated on 20 September 2007 with the adoption of a CHMP list of questions that were to be addressed by the marketing authorisation holders (MAHs).
Danish: Den 20. april 2005 fremlagde Pfizer under en høring oplysninger om alvorlige hudreaktioner i forbindelse med valdecoxib.
English: At the end of the mutual recognition procedure for the variation to extend the indication to include AS, there was a discrepancy between different European Union (EU) Member States regarding the safety of etoricoxib at the 90mg dose.
Danish: Disse oplysninger førte til, at indehaveren af markedsføringstilladelsen den 30. september 2004 trak rofecoxib (Vioxx) tilbage fra verdensmarkedet, og satte spørgsmålstegn ved den kardiovaskulære sikkerhed ved andre Cox-2-hæmmere.
English: Ebymect received a marketing authorisation valid throughout the EU on 15 November 2015.
Danish: Ebymect fik en markedsføringstilladelse med gyldighed i hele EU den 15. november 2015.
English: The majority of these data had already been used in the authorisation of Forxiga.
Danish: Størstedelen af dataene var allerede blevet brugt ved godkendelsen af Forxiga.
English: This authorisation was based on the authorisation granted to Xigduo in 2014 (‘informed consent').
Danish: Markedsføringstilladelsen var baseret på den tilladelse, som blev udstedt for Xigduo i 2014 ("informeret samtykke").
English: Further information on Ebymect can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/ebymect.
Danish: Yderligere information om Ebymect findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/ebymect.
English: Ebymect contains two different active substances, which work in different ways:
Danish: Ebymect indeholder to forskellige aktive stoffer, der virker på hver sin måde:
English: Ebymect must not be used in:
Danish: Ebymect må ikke anvendes hos:
English: Other information about Ebymect
Danish: Andre oplysninger om Ebymect
English: As for all medicines, data on the use of Ebymect are continuously monitored.
Danish: Som for alle lægemidler er data vedrørende brug af Ebymect løbende overvåget.
English: The European Medicines Agency decided that Ebymect's benefits are greater than its risks and recommended that it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Ebymect opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Ebymect?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ebymect?
English: Side effects reported with Ebymect are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Ebymect vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: An overview of Ebymect and why it is authorised in the EU
Danish: En oversigt over Ebymect, og hvorfor det er godkendt i EU
English: HbA1c is a substance in the blood which gives an indication of how well the blood glucose is controlled.
Danish: HbA1c er et stof i blodet, der fortæller, hvor godt blodsukkeret er reguleret.
English: For further information about using Ebymect, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Ebymect, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: Why is Ebymect authorised in the EU?
Danish: Hvorfor er Ebymect godkendt i EU?
English: Ebymect can also be used to replace dapagliflozin and metformin taken as separate tablets.
Danish: Ebymect kan derudover anvendes til at erstatte dapagliflozin og metformin som separate tabletter.
English: What is Ebymect and what is it used for?
Danish: Hvad er Ebymect, og hvad anvendes det til?
English: • patients with diabetic pre-coma (a dangerous condition that can occur in diabetes);
Danish: patienter med diabetisk prækoma (en farlig tilstand, der kan forekomme ved diabetes)
English: Dapagliflozin in combination with metformin was evaluated in 6 main studies involving 3,200 adults with type 2 diabetes.
Danish: Dapagliflozin kombineret med metformin blev vurderet i 6 hovedstudier med 3.200 voksne med type 2-diabetes.
English: • metformin works mainly by reducing glucose production and reducing its absorption from the gut.
Danish: Metformin virker hovedsagelig ved at reducere produktionen af glukose og mindske dets optagelse i tarmen.
English: The study indicated that dapagliflozin's effects were in line with those of other diabetes medicines that also work by blocking SGLT2.
Danish: Studiet viste, at dapagliflozins virkninger svarede til virkningerne af andre diabeteslægemidler, som også virkede ved at blokere SGLT2.
English: When Ebymect is added to treatment with insulin or a medicine that helps the body to produce insulin, such as a sulphonylurea, the doctor may need to lower the dose of insulin or sulphonylurea to prevent hypoglycaemia (low blood sugar levels).
Danish: Når Ebymect tilføjes til en behandling med insulin eller et lægemiddel, der hjælper kroppen med at producere insulin, f.eks. et sulfonylurinstof, kan lægen være nødt til at nedsætte dosen af insulin eller sulfonylurinstoffer for at forhindre hypoglykæmi (lavt blodsukker).
English: What are the risks associated with Ebymect?
Danish: Hvilke risici er der forbundet med Ebymect?
English: This leads to high levels of glucose in the blood.
Danish: Det medfører et forhøjet indhold af glukose i blodet.
English: Ebymect is available as tablets containing 5 mg of dapagliflozin with 850 mg of metformin and as 5 mg of dapagliflozin with 1,000 mg of metformin.
Danish: Ebymect fås som tabletter indeholdende 5 mg dapagliflozin med 850 mg metformin og som 5 mg dapagliflozin med 1.000 mg metformin.
English: Ebymect is a diabetes medicine that is used, together with diet and exercise in adults with type 2 diabetes.
Danish: Ebymect er et lægemiddel mod diabetes (sukkersyge), som anvendes sammen med diæt og motion til voksne med type 2-diabetes.
English: A long-term study, involving over 17,000 patients with type 2 diabetes, looked at the effects of dapagliflozin on cardiovascular (heart and circulation) disease.
Danish: Et studie, der omfattede over 17.000 patienter med type 2-diabetes, så på virkningerne af dapagliflozin på hjerte-karsygdomme.
English: • patients with any form of acute metabolic acidosis (build up of acid in the blood), such as diabetic ketoacidosis (high blood levels of acids called ketones) or lactic acidosis (build-up of lactic acid in the body);
Danish: patienter med en hvilken som helst form for akut metabolisk acidose (ophobning af syre i blodet), f.eks. diabetisk ketoacidose (høj koncentration i blodet af syrer kaldet ketoner) eller mælkesyreacidose (ophobning af mælkesyre i kroppen)
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the amount of glucose (sugar) in the blood or when the body cannot use insulin effectively.
Danish: Ved type 2-diabetes producerer bugspytkirtlen enten ikke nok insulin til at regulere mængden af glukose (sukker) i blodet, eller også kan kroppen ikke udnytte insulinet effektivt.
English: The most common side effects with Ebymect (which may affect more than 1 in 10 people) are hypoglycaemia (when used together with insulin or a sulphonylurea) and gastrointestinal symptoms (symptoms affecting the stomach and gut).
Danish: De hyppigste bivirkninger ved Ebymect (som kan forekomme hos mere end 1 ud af 10 personer), er for lavt blodsukker (hypoglykæmi) (ved brug sammen med insulin eller et sulfonylurinstof) og symptomer, der påvirker mave-tarm-kanalen (gastrointestinale symptomer).
English: For the full list of side effects with Ebymect, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Ebymect fremgår af indlægssedlen.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ebymect 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 Ebymect.
English: Further studies confirmed that different doses of dapagliflozin with metformin decreased HbA1c more than placebo plus comparable doses of metformin, and that dapagliflozin plus metformin was at least as effective in reducing HbA1c levels as the diabetes medicine glipizide (a type of medicine known as a sulphonylurea).
Danish: Yderligere studier bekræftede, at forskellige doser dapagliflozin med metformin nedbragte HbA1c mere end placebo plus tilsvarende doser af metformin, og at dapagliflozin plus metformin var mindst lige så effektivt til at nedbringe HbA1c som diabeteslægemidlet glipizid (et lægemiddel af typen sulfonylurinstoffer).
English: How is Ebymect used?
Danish: Hvordan anvendes Ebymect?
English: In one main study, when dapagliflozin was used at a dose of 5 mg twice a day in addition to metformin (the same combination as in Ebymect), it decreased HbA1c (glycosylated haemoglobin) levels by 0.65% after 16 weeks, compared with a reduction of 0.30% with placebo (a dummy treatment) and metformin.
Danish: I ét hovedstudie, hvor dapagliflozin blev anvendt i en dosis på 5 mg to gange dagligt som supplement til metformin (samme kombination som i Ebymect), nedsatte det koncentrationen af HbA1c (glykosyleret hæmoglobin) med 0,65 % efter 16 uger sammenholdt med en reduktion på 0,30 % med placebo (en uvirksom behandling) og metformin.
English: How does Ebymect work?
Danish: Hvordan virker Ebymect?
English: What benefits of Ebymect have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Ebymect?
English: By blocking the action of SGLT2, dapagliflozin causes the kidneys to pass out more glucose in the urine, thereby reducing the levels of glucose in the blood.
Danish: Ved at blokere virkningen af SGLT2 får dapagliflozin nyrerne til at udskille mere glukose gennem urinen, så glukoseindholdet i blodet falder.
English: • dapagliflozin blocks the action of a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2).
Danish: Dapagliflozin blokerer virkningen af proteinet natrium-glukose-kotransporter 2 (SGLT2) i nyrerne.
English: Two other studies showed that dapagliflozin taken with metformin and another diabetes medicine, sitagliptin or insulin, for 24 weeks, further decreased HbA1c: the dapagliflozin combination decreased HbA1c levels by 0.40% more than placebo and metformin when added to sitagliptin, and by 0.61% more than placebo and metformin when added to insulin.
Danish: To andre studier viste, at dapagliflozin, anvendt i 24 uger sammen med metformin og et andet diabeteslægemiddel, sitagliptin eller insulin, nedsatte HbA1c endnu mere: Dapagliflozin-kombinationen nedbragte her HbA1c-koncentrationen 0,40 % mere end placebo og metformin som tillægsbehandling til sitagliptin, og 0,61 % mere end placebo og metformin som tillægsbehandling til insulin.
English: One study showed that after 24 weeks of treatment, patients taking dapagliflozin plus metformin had an average reduction in body weight of around 2 kg more than those taking placebo plus metformin.
Danish: Ét studie viste, at patienter på dapagliflozin plus metformin efter 24 ugers behandling i gennemsnit tabte sig ca. 2 kg mere end dem, der fik placebo plus metformin.
English: The recommended dose is 1 tablet taken twice a day with a meal; the strength should be chosen so that in total, patients receive 10 mg of dapagliflozin each day and the same (or almost the same) dose of metformin they were taking before starting Ebymect.
Danish: Der skal vælges en styrke, så patienten i alt får 10 mg dapagliflozin dagligt, og den samme (eller næsten samme) dosis metformin, som patienten allerede fik inden behandlingen med Ebymect.
English: • patients with diseases that could cause tissue hypoxia (reduced levels of oxygen in body tissues), such as heart or lung failure (where the heart and lungs do not work as well as they should), recent heart attack or shock;
Danish: patienter med nedsat leverfunktion patienter med svært nedsat nyrefunktion eller med tilstande, der kan ændre nyrefunktionen, såsom dehydrering, svær infektion eller chok patienter med sygdomme, der kan forårsage vævshypoksi (lavt iltniveau i kropsvævet), som f.eks. hjerte- eller lungesvigt (hvor hjertet og lungerne ikke virker så godt, som de bør), og med nylige hjerteanfald eller chok patienter, som er påvirket af alkohol (berusede), eller som jævnligt drikker meget store mængder alkohol.
English: • in combination with other diabetes medicines when these medicines together with metformin are not controlling the diabetes well enough.
Danish: Ebymect anvendes: som enebehandling hos patienter, hvis sygdom ikke reguleres tilstrækkeligt med metformin alene i kombination med andre lægemidler mod diabetes, når disse lægemidler sammen med metformin ikke kan regulere diabetes tilstrækkeligt.
English: The Agency considered Ebymect to be effective for treating type 2 diabetes; it also leads to weight loss, which is considered beneficial in patients with diabetes.
Danish: Agenturet fandt, at Ebymect var effektivt til behandling af type 2-diabetes.
English: When should I not have Blitzima?
Danish: Hvornår må jeg ikke få Blitzima?
English: Do not have Blitzima if you have an active infection or a serious problem with your immune system.
Danish: Du må ikke få Blitzima, hvis du har en aktiv infektion eller alvorlige problemer med dit immunsystem.
English: Do not have Blitzima if any of the above apply to you.
Danish: Du må ikke få Blitzima, hvis ét eller flere af ovenstående punkter gælder for dig.
English: Your doctor may decide to treat you longer with Blitzima (up to 5 years), depending on how you respond to the medicine.
Danish: Din læge kan beslutte at behandle dig i længere tid med Blitzima (op til 5 år), alt efter hvor godt du reagerer på medicinen.
English: Blitzima may be used for the treatment of several different conditions in adults.
Danish: Blitzima kan anvendes til behandling af flere forskellige tilstande hos voksne.
English: Before you are given Blitzima, you will be given other medicines (pre-medication) to prevent or reduce possible side effects.
Danish: Inden du får Blitzima, vil du få anden medicin (præmedicin), der forebygger eller mindsker mulige bivirkninger.
English: Blitzima is a biosimilar medicinal product.
Danish: Blitzima er et biosimilært lægemiddel.
English: Blitzima is indicated in adults for the following indications:
Danish: Blitzima er indiceret hos voksne til følgende indikationer:
English: Patients should receive Blitzima for at least 24 months after achievement of remission (absence of clinical signs and symptoms).
Danish: Patienter skal gives Blitzima i mindst 24 måneder efter opnåelse af remission (fravær af kliniske symptomer).
English: See the Blitzima package leaflet for more information.
Danish: Se indlægssedlen i Blitzima-pakken for mere information.
English: Some vaccines should not be given at the same time as Blitzima or in the months after you receive Blitzima.
Danish: Nogle vaccinationer bør ikke gives på samme tid som Blitzima eller i månederne efter du har fået Blitzima.
English: • The need to monitor patients for infections, especially PML, during and after Blitzima treatment
Danish: • Nødvendigheden af at overvåge patienterne for infektioner, især PML, under og efter behandling med Blitzima
English: • Show this card to any doctor, nurse or dentist you see - not just the specialist who prescribes your Blitzima.
Danish: • Vis dette kort til enhver læge, sygeplejerske eller tandlæge, som er involveret i din behandling - og ikke kun til den læge, der udskriver Blitzima til dig
English: Blitzima in combination with chemotherapy destroys these cells which are gradually removed from the body by biological processes.
Danish: Blitzima anvendt sammen med kemoterapi ødelægger disse celler, som gradvis fjernes fra kroppen ved biologiske processer.