FrancophonIA/ELRC3.0 huggingface dataset:
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 80 mg/5 mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP Blister med 7 tabletter - 80 mg/5 mg
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 80 mg/10 mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP Blister med 7 tabletter - 80 mg/10 mg
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 40 mg/10 mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP Blister med 7 tabletter - 40 mg/10 mg
English: Musculoskeletal and connective tissue disorders Common ankle swelling
Danish: Knogler, led, muskler og bindevæv: Almindelige ankelhævelse
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 40 mg/5 mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP Blister med 7 tabletter - 40 mg/5 mg
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister of 10 tablets - 80 mg/5 mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP Unit dose-blister af 10 tabletter - 80 mg/5 mg
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister of 10 tablets - 40 mg/10 mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP Unit dose-blister af 10 tabletter - 40 mg/10 mg
English: Each tablet contains 40 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
Danish: Hver tablet indeholder 40 mg telmisartan og 5 mg amlodipin (som amlodipinbesilat).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister of 10 tablets - 80 mg/10 mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP Unit dose-blister af 10 tabletter - 80 mg/10 mg
English: Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
Danish: Hver tablet indeholder 80 mg telmisartan og 5 mg amlodipin (som amlodipinbesilat).
English: Each tablet contains 40 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
Danish: Hver tablet indeholder 40 mg telmisartan og 10 mg amlodipin (som amlodipinbesilat).
English: Each tablet contains 80 mg telmisartan and 10 mg amlodipine (as amlodipine besilate).
Danish: Hver tablet indeholder 80 mg telmisartan og 10 mg amlodipin (som amlodipinbesilat).
English: Package leaflet: Information for the user Twynsta 80 mg/10 mg tablets Telmisartan/Amlodipine
Danish: Indlægsseddel: Information til brugeren Twynsta 80 mg /10 mg tabletter telmisartan/amlodipin
English: Package leaflet: Information for the user Twynsta 40 mg/5 mg tablets Telmisartan/Amlodipine
Danish: Indlægsseddel: Information til brugeren Twynsta 40 mg /5 mg tabletter telmisartan/amlodipin
English: Package leaflet: Information for the user Twynsta 40 mg/10 mg tablets Telmisartan/Amlodipine
Danish: Indlægsseddel: Information til brugeren Twynsta 40 mg /10 mg tabletter telmisartan/amlodipin
English: Package leaflet: Information for the user Twynsta 80 mg/5 mg tablets Telmisartan/Amlodipine
Danish: Indlægsseddel: Information til brugeren Twynsta 80 mg /5 mg tabletter telmisartan/amlodipin
English: What Twynsta looks like and contents of the pack Twynsta 80 mg/5 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A3 and the company logo on the white layer.
Danish: Twynsta 80 mg/5 mg tabletter er blå og hvide ovale tolagstabletter præget med produktkoden A3 og firmalogo på den hvide side.
English: Twynsta 40 mg/10 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg alone.
Danish: Twynsta 40 mg/10 mg tabletter kan ordineres til patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret med 10 mg amlodipin alene.
English: What Twynsta looks like and contents of the pack Twynsta 40 mg/5 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A1 and the company logo on the white layer.
Danish: Twynsta 40 mg/5 mg tabletter er blå og hvide ovale tolagstabletter præget med produktkoden A1 og firmalogo på den hvide side.
English: EU/1/10/648/001 (14 tablets) EU/1/10/648/002 (28 tablets) EU/1/10/648/003 (30 x 1 tablets) EU/1/10/648/004 (56 tablets) EU/1/10/648/005 (90 x 1 tablets) EU/1/10/648/006 (98 tablets)
Danish: EU/1/10/648/001 (14 tabletter) EU/1/10/648/002 (28 tabletter) EU/1/10/648/003 (30 x 1 tabletter) EU/1/10/648/004 (56 tabletter) EU/1/10/648/005 (90 x 1 tabletter) EU/1/10/648/006 (98 tabletter)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister of 10 tablets - 40 mg/5 mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP Unit dose-blister med 10 tabletter - 40 mg/5 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/648/007 (360 (4 x 90 x 1) tablets)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/10/648/007 (360 (4 x 90 x 1) tabletter)
English: What Twynsta looks like and contents of the pack Twynsta 40 mg/10 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A2 and the company logo on the white layer.
Danish: Twynsta 40 mg/10 mg tabletter er blå og hvide ovale tolagstabletter præget med produktkoden A2 og firmalogo på den hvide side.
English: EU/1/10/648/001 (14 tablets) EU/1/10/648/002 (28 tablets) EU/1/10/648/003 (30 x 1 tablets) EU/1/10/648/004 (56 tablets) EU/1/10/648/005 (90 x 1 tablets) EU/1/10/648/006 (98 tablets) EU/1/10/648/007 (360 (4 x 90 x 1) tablets)
Danish: EU/1/10/648/001 (14 tabletter) EU/1/10/648/002 (28 tabletter) EU/1/10/648/003 (30 x 1 tabletter) EU/1/10/648/004 (56 tabletter) EU/1/10/648/005 (90 x 1 tabletter) EU/1/10/648/006 (98 tabletter) EU/1/10/648/007 (360 (4 x 90 x 1) tabletter)
English: What Twynsta looks like and contents of the pack Twynsta 80 mg/10 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A4 and the company logo on the white layer.
Danish: Twynsta 80 mg/10 mg tabletter er blå og hvide ovale tolagstabletter præget med produktkoden A4 og firmalogo på den hvide side.
English: NAME OF THE MEDICINAL PRODUCT Twynsta 40 mg/5 mg tablets telmisartan/amlodipine
Danish: LÆGEMIDLETS NAVN Twynsta 40 mg/5 mg tabletter telmisartan/amlodipin
English: Uncommon visual impairment
Danish: Ikke almindelige nedsat syn
English: EU/1/10/648/022 (14 tablets) EU/1/10/648/023 (28 tablets) EU/1/10/648/024 (30 x 1 tablets) EU/1/10/648/025 (56 tablets) EU/1/10/648/026 (90 x 1 tablets) EU/1/10/648/027 (98 tablets)
Danish: EU/1/10/648/022 (14 tabletter) EU/1/10/648/023 (28 tabletter) EU/1/10/648/024 (30 x 1 tabletter) EU/1/10/648/025 (56 tabletter) EU/1/10/648/026 (90 x 1 tabletter) EU/1/10/648/027 (98 tabletter)
English: NAME OF THE MEDICINAL PRODUCT Twynsta 80 mg/5 mg tablets telmisartan/amlodipine
Danish: LÆGEMIDLETS NAVN Twynsta 80 mg/5 mg tabletter telmisartan/amlodipin
English: EU/1/10/648/008 (14 tablets) EU/1/10/648/009 (28 tablets) EU/1/10/648/010 (30 x 1 tablets) EU/1/10/648/011 (56 tablets) EU/1/10/648/012 (90 x 1 tablets) EU/1/10/648/013 (98 tablets)
Danish: EU/1/10/648/008 (14 tabletter) EU/1/10/648/009 (28 tabletter) EU/1/10/648/010 (30 x 1 tabletter) EU/1/10/648/011 (56 tabletter) EU/1/10/648/012 (90 x 1 tabletter) EU/1/10/648/013 (98 tabletter)
English: EU/1/10/648/015 (14 tablets) EU/1/10/648/016 (28 tablets) EU/1/10/648/017 (30 x 1 tablets) EU/1/10/648/018 (56 tablets) EU/1/10/648/019 (90 x 1 tablets) EU/1/10/648/020 (98 tablets)
Danish: EU/1/10/648/015 (14 tabletter) EU/1/10/648/016 (28 tabletter) EU/1/10/648/017 (30 x 1 tabletter) EU/1/10/648/018 (56 tabletter) EU/1/10/648/019 (90 x 1 tabletter) EU/1/10/648/020 (98 tabletter)
English: NAME OF THE MEDICINAL PRODUCT Twynsta 80 mg/10 mg tablets telmisartan/amlodipine
Danish: LÆGEMIDLETS NAVN Twynsta 80 mg /10 mg tabletter telmisartan/amlodipin
English: EU/1/10/648/022 (14 tablets) EU/1/10/648/023 (28 tablets) EU/1/10/648/024 (30 x 1 tablets) EU/1/10/648/025 (56 tablets) EU/1/10/648/026 (90 x 1 tablets) EU/1/10/648/027 (98 tablets) EU/1/10/648/028 (360 (4 x 90 x 1) tablets)
Danish: EU/1/10/648/022 (14 tabletter) EU/1/10/648/023 (28 tabletter) EU/1/10/648/024 (30 x 1 tabletter) EU/1/10/648/025 (56 tabletter) EU/1/10/648/026 (90 x 1 tabletter) EU/1/10/648/027 (98 tabletter) EU/1/10/648/028 (360 (4 x 90 x 1) tabletter)
English: EU/1/10/648/008 (14 tablets) EU/1/10/648/009 (28 tablets) EU/1/10/648/010 (30 x 1 tablets) EU/1/10/648/011 (56 tablets) EU/1/10/648/012 (90 x 1 tablets) EU/1/10/648/013 (98 tablets) EU/1/10/648/014 (360 (4 x 90 x 1) tablets)
Danish: EU/1/10/648/008 (14 tabletter) EU/1/10/648/009 (28 tabletter) EU/1/10/648/010 (30 x 1 tabletter) EU/1/10/648/011 (56 tabletter) EU/1/10/648/012 (90 x 1 tabletter) EU/1/10/648/013 (98 tabletter) EU/1/10/648/014 (360 (4 x 90 x 1) tabletter)
English: Blue and white oval shaped two layer tablets engraved with the product code A1 and the company logo on the white layer.
Danish: Tablet Blå og hvide ovale tolagstabletter præget med produktkoden A1 og firmalogo på den hvide side.
English: NAME OF THE MEDICINAL PRODUCT Twynsta 40 mg /10 mg tablets telmisartan/amlodipine
Danish: LÆGEMIDLETS NAVN Twynsta 40 mg /10 mg tabletter telmisartan/amlodipin
English: EU/1/10/648/015 (14 tablets) EU/1/10/648/016 (28 tablets) EU/1/10/648/017 (30 x 1 tablets) EU/1/10/648/018 (56 tablets) EU/1/10/648/019 (90 x 1 tablets) EU/1/10/648/020 (98 tablets) EU/1/10/648/021 (360 (4 x 90 x 1) tablets)
Danish: EU/1/10/648/015 (14 tabletter) EU/1/10/648/016 (28 tabletter) EU/1/10/648/017 (30 x 1 tabletter) EU/1/10/648/018 (56 tabletter) EU/1/10/648/019 (90 x 1 tabletter) EU/1/10/648/020 (98 tabletter) EU/1/10/648/021 (360 (4 x 90 x 1) tabletter)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/648/014 (360 (4 x 90 x 1) tablets)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/10/648/014 (360 (4 x 90 x 1) tabletter)
English: Blue and white oval shaped two layer tablets engraved with the product code A3 and the company logo on the white layer.
Danish: Tablet Blå og hvide ovale tolagstabletter præget med produktkoden A3 og firmalogo på den hvide side.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF THE MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) - WITHOUT BLUE BOX - 80 mg/5 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Inderpakning til multipakning med 360 tabletter (4 pakninger af 90 x 1 tabletter) - uden Blue Box - 80 mg/5 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF THE MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) - WITHOUT BLUE BOX - 40 mg/5 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Inderpakning til multipakning med 360 tabletter (4 pakninger af 90 x 1 tabletter) - uden Blue Box - 40 mg/5 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/648/021 (360 (4 x 90 x 1) tablets)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/10/648/021 (360 (4 x 90 x 1) tabletter)
English: Blue and white oval shaped two layer tablets engraved with the product code A4 and the company logo on the white layer.
Danish: Tablet Blå og hvide ovale tolagstabletter præget med produktkoden A4 og firmalogo på den hvide side.
English: Blue and white oval shaped two layer tablets engraved with the product code A2 and the company logo on the white layer.
Danish: Tablet Blå og hvide ovale tolagstabletter præget med produktkoden A2 og firmalogo på den hvide side.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/648/028 (360 (4 x 90 x 1) tablets)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/10/648/028 (360 (4 x 90 x 1) tabletter)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL ON MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) BUNDLEDINCLUDING THE BLUE BOX - 40 mg/10 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre etiket til bundtet multipakning med 360 tabletter (4 pakninger af 90 x 1 tabletter) - med Blue Box - 40 mg/10 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL ON MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) BUNDLEDINCLUDING THE BLUE BOX - 40 mg/5 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre etiket på bundtet multipakning med 360 tabletter (4 pakninger af 90 x 1 tabletter) - med Blue Box - 40 mg/5 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF THE MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) - WITHOUT BLUE BOX - 40 mg/10 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Inderpakning til bundtet multipakning med 360 tabletter (4 pakninger af 90 x tabletter) - uden Blue Box - 40 mg/10 mg
English: If you take more Twynsta than you should
Danish: Hvis du har taget for mange Twynsta
English: The three main studies involved a total of almost 113,000 people.
Danish: De tre hovedundersøgelser omfattede i alt næsten 113 000 mennesker.
English: The company also presented data from the published literature.
Danish: Virksomheden har også fremlagt data fra den offentliggjorte litteratur.
English: This subunit is not toxic by itself.
Danish: Denne subunit er ikke i sig selv giftig.
English: The course should be completed at least one week before potential exposure to cholera.
Danish: Forløbet bør være afsluttet mindst én uge inden en potentiel eksponering for kolera.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Dukoral on 28 April 2004.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Dukoral den 28. april 2004.
English: This document is a summary of the European public assessment report (EPAR) for Dukoral.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Dukoral.
English: Dukoral cholera vaccine (inactivated, oral)
Danish: Dukoral koleravaccine (inaktiveret, oral)
English: The studies took place in areas where cholera is found.
Danish: Undersøgelserne fandt sted i områder, hvor der findes kolera.
English: The full EPAR for Dukoral can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Dukoral findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In adults, two vaccine doses were shown to be as effective as three.
Danish: Hos voksne viste det sig, at to vaccinedoser var lige så effektive som tre.
English: Dukoral is a vaccine.
Danish: Dukoral er en vaccine.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to protect itself against a disease.
Danish: Vacciner virker ved at ”lære” immunsystemet (kroppens naturlige forsvar), hvordan det skal beskytte sig mod en sygdom.
English: Food, drink and other medicines taken by mouth should be avoided for one hour before and one hour after each dose of Dukoral.
Danish: Mad, drikke og anden medicin, som indtages via munden, bør undgås i én time før og én time efter hver dosis Dukoral.
English: Once prepared, the suspension should be drunk within two hours.
Danish: Når suspensionen er klargjort, skal den drikkes inden for to timer.
English: Because Dukoral has been in use in Sweden since 1991, the company presented the results of three main studies that had already been carried out in order to support the use of Dukoral.
Danish: Da Dukoral har været anvendt i Sverige siden 1991, har virksomheden fremlagt resultater fra tre hovedundersøgelser, som allerede er blevet gennemført for at understøtte brugen af Dukoral.
English: The CHMP noted that the risk of cholera for regular tourists is minor, but that Dukoral could be important for certain groups, such as healthcare workers in cholera epidemics.
Danish: CHMP bemærkede, at risikoen for kolera for almindelige turister er mindre betydelig, men at Dukoral kan være vigtig for visse grupper såsom sundhedspersonale under koleraepidemier.
English: The people in the final study also received a booster dose 10 to 12 months later.
Danish: Personerne i den sidste undersøgelse fik også en boosterdosis 10 til 12 måneder senere.
English: Dukoral should not replace standard protective measures against cholera, including advice on diet and hygiene.
Danish: Dukoral bør ikke erstatte beskyttende standardforanstaltninger mod kolera, herunder råd om kost og hygiejne.
English: Dukoral is used in adults, adolescents and children from two years of age who will be visiting high-risk areas.
Danish: Dukoral anvendes til voksne, unge og børn fra toårsalderen, som skal besøge højrisikoområder.
English: Other information about Dukoral:
Danish: Andre oplysninger om Dukoral
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Dukoral.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Dukoral skal anvendes.
English: For more information about treatment with Dukoral, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Dukoral, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Dukoral must not be used in people who may be hypersensitive (allergic) to any of the active substances, to any of the other ingredients or to formaldehyde.
Danish: Dukoral må ikke anvendes hos personer, som kan være overfølsomme (allergiske) over for nogen af de aktive stoffer, andre af indholdsstofferne eller formaldehyd.
English: A further study was carried out to show that Dukoral could produce antibodies in people who do not come from areas where cholera is found.
Danish: Endnu en undersøgelse blev foretaget for at vise, at Dukoral kunne producere antistoffer hos mennesker, som ikke kommer fra områder, hvor der findes kolera.
English: Dukoral is used to protect against cholera (a very serious disease caused by V. cholerae, which is caught from contaminated food or water and causes severe diarrhoea).
Danish: Dukoral anvendes til at beskytte imod kolera (en meget alvorlig sygdom, der skyldes V. cholerae, som man får af forurenet mad eller vand, og som giver alvorlig diarré).
English: The vaccine contains four different inactivated strains (types) of the bacterium Vibrio cholerae (V. cholerae) serotype O1, and part of a toxin from one of these strains as active substances.
Danish: Vaccinen indeholder fire forskellige inaktiverede stammer (typer) af bakterien Vibrio cholerae (V. cholerae) serotype O1 og en del af et toksin fra en af disse stammer som aktive stoffer.
English: The granules are dissolved in water and mixed with the vaccine before intake.
Danish: Granulatet opløses i vand og blandes med vaccinen inden indtagelsen.
English: The course should be repeated in adults who have not been given a booster within two years and in children not given a booster within six months.
Danish: Forløbet bør gentages hos voksne, som ikke har fået en booster inden to år, og hos børn, som ikke har fået en booster inden seks måneder.
English: The first study involved over 89,000 people in Bangladesh and compared Dukoral with the same vaccine without the toxin and with placebo.
Danish: Den første undersøgelse omfattede over 89 000 mennesker i Bangladesh og sammenlignede Dukoral med samme vaccine uden toksinet og med placebo.
English: In the future, the immune system will be able to produce antibodies more quickly when it is exposed to cholera bacteria.
Danish: Herefter vil immunsystemet være i stand til at producere antistoffer hurtigere, når det bliver udsat for kolerabakterier.
English: Dukoral is a vaccine that is given by mouth.
Danish: Dukoral er en vaccine, der tages gennem munden.
English: The company also presented information on the use of Dukoral for the prevention of a severe type of traveller's diarrhoea caused by a bacterium called ‘enterotoxigenic Escherichia coli'.
Danish: Virksomheden fremlagde også oplysninger om brug af Dukoral til forebyggelse af en alvorlig type turistdiarré forårsaget af en bakterie ved navn ”enterotoksigen Escherichia coli”.
English: What is the risk associated with Dukoral?
Danish: Hvilken risiko er der forbundet med Dukoral?
English: The information presented was not sufficient to support the use of Dukoral in traveller's diarrhoea.
Danish: De fremlagte oplysninger var ikke tilstrækkelige til at understøtte brugen af Dukoral til turistdiarré.
English: These antibodies will help to protect against cholera by preventing the bacteria and the toxins from attaching to the walls of the gut and entering the body's cells.
Danish: Disse antistoffer hjælper med at beskytte imod kolera ved at forhindre bakterierne og toksinerne i at angribe tarmvæggene og trænge ind i kroppens celler.
English: Its use should be postponed in patients with a short-lived illness affecting the stomach or gut, or with a fever.
Danish: Brug af Dukoral bør udsættes hos patienter med en kortvarig sygdom, som påvirker mave eller tarm, eller patienter, som har feber.
English: For continuous protection against cholera, a single booster dose is recommended within two years for people from six years of age, and within six months for children aged between two and six years.
Danish: For at opretholde beskyttelsen imod kolera anbefales en enkelt boosterdosis inden to år for personer fra seksårsalderen og inden seks måneder for børn i alderen fra to til seks år.
English: The Committee decided that Dukoral's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget fandt, at fordelene ved Dukoral opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Dukoral.
English: The other two studies compared Dukoral (containing recombinant cholera toxin) with placebo in over 22,000 people in Peru.
Danish: De andre to undersøgelser sammenlignede Dukoral (indeholdende rekombinant koleratoksin) med placebo hos mere end 22 000 mennesker i Peru.
English: When a person is given the vaccine, the immune system recognises the bacteria and the toxin, and makes antibodies against them.
Danish: Når en person vaccineres, genkender immunsystemet bakterierne og toksinet og reagerer ved at danne antistoffer imod dem.
English: Why has Dukoral been approved?
Danish: Hvorfor blev Dukoral godkendt?
English: It is available as a suspension in a bottle together with effervescent granules in a sachet.
Danish: Det fås som suspension i en flaske sammen med et brev med brusegranulat.
English: In all three studies, Dukoral, given as either two or three doses, was compared with placebo (a dummy vaccine).
Danish: I alle tre undersøgelser blev Dukoral, givet som enten to eller tre doser, sammenlignet med placebo (en virkningsløs behandling).
English: Children aged between two and six years should receive three doses, with an interval of one to six weeks between each dose.
Danish: Børn i alderen fra to til seks år skal have tre doser med et interval på en til seks uger imellem hver dosis.
English: Dukoral contains small amounts of inactivated (killed) cholera bacteria and a part of the cholera toxin called the ‘B subunit'.
Danish: Dukoral indeholder små mængder af inaktiverede (døde) kolerabakterier og en del af det koleratoksin, som kaldes ”B subunit”.
English: The vaccine is made up by dissolving the granules in a glass of water to prepare an effervescent (sparkling) solution, and adding the contents of the bottle.
Danish: Vaccinen klargøres ved at opløse granulatet i et glas vand for at få en brusende opløsning, og tilsætte indholdet af flasken.
English: In this study, Dukoral was made using cholera toxin extracted from cholera bacteria in place of the newer recombinant toxin.
Danish: I denne undersøgelse blev Dukoral fremstillet ved hjælp af koleratoksin udtrukket fra kolerabakterier i stedet for det nyere rekombinante toksin.
English: In adults and children from six years of age, Dukoral is given as two doses, one to six weeks apart.
Danish: Hos voksne og børn fra seksårsalderen gives Dukoral som to doser med én til seks ugers mellemrum.