FrancophonIA/ELRC3.0 huggingface dataset:
English: The effervescent granules are filled in an amount of 5.6 g in sachets with an inner layer of polyester/LD-polyethylene and an outer layer of aluminium/LD-polyethylene.
Danish: Brusegranulatet er i mængder a 5,6 g fyldt i breve med et indvendigt lag af polyester/LD-polyethylen og et udvendigt lag af aluminium/LD-polyethylen.
English: The vaccine does not provide complete protection and it is important to adhere additionally to standard protective measures to avoid cholera.
Danish: Vaccinen giver ikke fuldstændig beskyttelse, og det er vigtigt også at overholde de beskyttende standardforanstaltninger til forebyggelse af kolera.
English: Dukoral causes your body to produce its own protection against cholera.
Danish: Dukoral får kroppen til at danne sin egen beskyttelse mod kolera.
English: Pack sizes: 1x1 dose, 2x1 dose, 20x1 dose Not all pack sizes may be marketed.
Danish: Pakningsstørrelser: 1x1 dosis, 2x1 dosis, 20x1 dosis Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: The standard primary course of vaccination with Dukoral against cholera consists of 2 doses for adults and children from 6 years of age.
Danish: Det primære standardforløb med vaccination med Dukoral mod kolera består af 2 doser til voksne og børn fra 6 år.
English: Dukoral is available in packs of 1, 2 and 20 doses.
Danish: Dukoral fås i pakninger med 1, 2 og 20 doser.
English: 6 months-5 years
Danish: 6 mdr.-5 år
English: Preliminary results from a clinical study including a limited number of volunteers showed no interaction with the antibody response to Dukoral when a live oral vaccine (enterocapsules) against typhoid was given simultaneously with Dukoral.
Danish: De foreløbige resultater af en klinisk undersøgelse, hvor et begrænset antal frivillige forsøgspersoner deltog, viste ingen interaktion med antistofreaktionen på Dukoral, da en levende oral vaccine (enterokapsler) mod tyfus blev givet samtidig med Dukoral.
English: To be used with DUKORAL.
Danish: Skal anvendes sammen med DUKORAL.
English: Administration of Dukoral should be postponed for subjects suffering from acute gastrointestinal illness or acute febrile illness.
Danish: Administrationen af Dukoral bør udsættes, hvis personen, der skal vaccineres, lider af akut gastrointestinal sygdom eller akut sygdom med feber.
English: Primary vaccination schedule
Danish: Primært vaccinationsforløb
English: Similarly, a yellow fever vaccine was given concomitantly with Dukoral, and there was no interaction observed with the immune response to the yellow fever vaccine.
Danish: En vaccine mod gul feber blev også givet samtidig med Dukoral, og der blev ikke observeret nogen interaktion med immunreaktionen på vaccinen mod gul feber.
English: Dukoral is indicated for active immunisation against disease caused by Vibrio cholerae serogroup O1 in adults and children from 2 years of age who will be visiting endemic/epidemic areas.
Danish: Dukoral er indiceret til aktiv immunisering mod sygdomme, der skyldes Vibrio cholerae serogruppe O1, af voksne og børn fra 2 år, som skal rejse til endemiske/epidemiske områder.
English: Dosage regimen
Danish: Doseringsregimen
English: The vaccine does not provide complete protection and it is important to adhere to dietary and hygiene advice to avoid diarrhoeal diseases.
Danish: Vaccinen giver ikke fuldstændig beskyttelse, og det er vigtigt at overholde anbefalingerne vedrørende kost og hygiejne for at undgå diaré.
English: • severe diarrhoea with loss of water from the body
Danish: • kraftig diaré med væsketab fra kroppen
English: Sodium dihydrogen phosphate dihydrate 2.0 mg, disodium hydrogen phosphate dihydrate 9.4 mg, sodium chloride 26 mg, sodium hydrogen carbonate 3600 mg, sodium carbonate anhydrous 400 mg, saccharin sodium 30 mg, sodium citrate 6 mg.
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på Natriumdihydrogenphosphatdihydrat 2,0 mg, dinatriumhydrogenphosphatdihydrat 9,4 mg, natriumchlorid 26 mg, natriumhydrogencarbonat 3.600 mg, vandfri natriumcarbonat 400 mg, saccharinnatrium 30 mg, natriumcitrat 6 mg.
English: You can take the 2nd dose of Dukoral up to 6 weeks after the 1st dose (children of 2 to below 6 years have to take 3 doses).
Danish: De kan tage den anden dosis af Dukoral op til 6 uger efter den første dosis (børn fra 2 til under 6 år skal tage 3 doser).
English: Metabolism and nutrition disorder Rare
Danish: Metabolisme og ernæring Sjælden
English: - Make sure to mix the vaccine with buffer solution as described in this leaflet.
Danish: - Vaccinen skal blandes med bufferopløsningen som beskrevet i denne indlægsseddel.
English: Please tell your doctor if you are taking or have recently taken any other medicines.
Danish: Fortæl det altid til lægen, hvis De bruger anden medicin eller har gjort det for nylig.
English: Children 2 to below 6 years of age should receive 3 doses.
Danish: Børn i alderen fra 2 til under 6 år skal have 3 doser.
English: Valneva Sweden AB, Sweden
Danish: Valneva Sweden AB, Sverige
English: Efficacy against cholera was assessed in three randomised double-blind placebo-controlled clinical trials conducted in Bangladesh (endemic region) and in Peru (non-endemic region).
Danish: Effektiviteten over for kolera blev vurderet i tre randomiserede, dobbeltblinde, placebokontrollerede kliniske studier, der blev gennemført i Bangladesh (endemisk område) og Peru (ikke-endemisk område).
English: It is important to use the buffer solution, as it protects the vaccine from the gastric acid.
Danish: Det er vigtigt at bruge bufferopløsningen, da den beskytter vaccinen mod mavesyren.
English: There is a poor correlation between serum antibody responses, including vibriocidal antibody response, and protection.
Danish: Der er ringe sammenhæng mellem antistofreaktionerne i serum (herunder den vibriocide antistofreaktion) og beskyttelsen.
English: The immune responses to Dukoral were not studied.
Danish: Immunreaktionerne på Dukoral blev ikke undersøgt.
English: Vaccine protective efficacy has not been studied.
Danish: Vaccinens beskyttende effekt er ikke undersøgt.
English: Year
Danish: År
English: There are no reasons to suspect that Dukoral will affect your ability to drive or handle machines
Danish: Der er ikke grund til at tro, at Dukoral vil påvirke Deres evne til at føre motorkøretøj elle betjene maskiner.
English: • Swelling irritation inside the nose, and cough.
Danish: • Hævelse og irritation i næsen samt hoste.
English: Dukoral may not induce protective antibody levels in subjects with advanced HIV disease.
Danish: Dukoral inducerer muligvis ikke beskyttende antistofniveauer hos personer med fremskreden HIV.
English: Do not use Dukoral after the expiry date which is stated on the carton after EXP.
Danish: Brug ikke Dukoral efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Caution should be taken in subjects with known hypersensitivity to formaldehyde.
Danish: Der skal udvises forsigtighed ved anvendelse af vaccinen til personer med kendt overfølsomhed over for formaldehyd.
English: Additional adverse reactions reported during post-marketing surveillance are listed below.
Danish: Yderligere bivirkninger, der blev indberettet under overvågningen efter markedsføring af vaccinen, er beskrevet i nedenstående.
English: Pour the content of the Dukoral® suspension vial into the glass of buffer solution (see 1).
Danish: Hæld indholdet af hætteglasset med Dukoral® suspension i glasset med bufferopløsning (se 1).
English: After the effervescent granules have been dissolved in water and the vaccine suspension has been added, the mixture should be drunk within 2 hours.
Danish: Når brusegranulatet er opløst i vand, og vaccinesuspensionen er tilsat, skal blandingen drikkes inden for 2 timer.
English: There is no evidence of an effect on the ability to drive and use machines.
Danish: Der er ikke påvist nogen påvirkning af evnen til at føre motorkøretøj eller betjene maskiner.
English: The vaccine contains killed whole V. cholerae O1 bacteria and the recombinant non-toxic B-subunit of the cholera toxin (CTB).
Danish: Vaccinen indeholder hele dræbte V. cholerae O1 -bakterier og den rekombinante non-toksiske Bsubenhed af koleratoksinet (CTB).
English: No established immunological correlates of protection against cholera after oral vaccination have been identified.
Danish: Der er ikke fundet nogen anerkendte immunologiske korrelater for beskyttelse mod kolera efter oral vaccination.
English: Loss of /or poor appetite Very rare Dehydration
Danish: Ingen appetit/mangel på appetit Meget sjældne Dehydrering
English: 3 ml of suspension in a vial.
Danish: 3 ml suspension i et hætteglas.
English: The antibacterial intestinal antibodies prevent the bacteria from attaching to the intestinal wall thereby impeding colonisation of V. cholerae O1.
Danish: De antibakterielle antistoffer i tarmene forhindrer bakterierne i at hæfte på tarmvæggen og hæmmer dermed kolonisering af V. cholerae O1.
English: The most frequently reported adverse reactions, such as gastrointestinal symptoms including abdominal pain, diarrhoea, loose stools, nausea and vomiting, occurred at similar frequencies in vaccine and placebo groups.
Danish: De hyppigst indberettede bivirkninger, såsom gastrointestinale symptomer og herunder mavesmerter, diaré, tynd afføring, nausea og opkastninger, forekom med ensartet hyppighed i grupperne, der fik henholdsvis vaccine og placebo.
English: 3 ml of suspension in a vial and 5.6 g of effervescent granules in a sachet.
Danish: 3 ml suspension i et hætteglas og 5,6 g brusegranulat i et brev.
English: Dukoral is an oral vaccine against cholera that stimulates the immunological defence in the gut.
Danish: Dukoral er en oral vaccine mod kolera, der stimulerer immunforsvaret i tarmen.
English: If more than 2 years have elapsed since the last vaccination (more than 6 months for children aged 2 to below 6 years) the primary course should be repeated.
Danish: Hvis mere end 2 år er forløbet siden seneste vaccination (mere end 6 måneder for børn i alderen fra 2 til under 6 år), bør det primære forløb gentages.
English: The vaccine vial should be shaken gently and the vaccine suspension should then be added to the buffer solution and mixed well to get the colourless slightly opalescent oral suspension.
Danish: Hætteglasset med vaccinen skal rystes forsigtigt, og vaccinesuspensionen sættes herefter til bufferopløsningen og blandes grundigt, så man får en farveløs, let opaliserende oral suspension.
English: The safety of Dukoral was assessed in clinical trials, including both adults and children from 2 years of age, conducted in endemic and non-endemic countries for cholera and enterotoxigenic Escherichia coli (ETEC) producing heat-labile enterotoxin (LT).
Danish: Sikkerheden ved Dukoral blev vurderet i kliniske studier med deltagelse af såvel voksne som børn på 2 år og opefter, der blev gennemført i lande, der var både endemiske og ikke-endemiske for kolera og enterotoksigen Escherichia coli (ETEC), der producerer varmelabile enterotoksiner (LT).
English: One dose contains approximately 1.1 g sodium.
Danish: Én dosis indeholder ca. 1,1 g natrium.
English: PACKAGE LEAFLET: INFORMATION FOR THE USER DUKORAL suspension and effervescent granules for oral suspension
Danish: Indlægsseddel: Information til brugeren DUKORAL suspension og brusegranulat til oral suspension
English: For storage conditions after first opening of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter første åbning af præparatet, se pkt.
English: A booster dose elicited an anamnestic response indicative of an immune memory.
Danish: En booster-dosis udløste en anamnestisk reaktion, hvilket kan tyde på en immunhukommelse.
English: Following careful benefit/risk assessment the vaccine may be administered during pregnancy and to breast-feeding women although no specific clinical studies have been performed to address this issue.
Danish: Efter nøje vurdering af fordele kontra risici kan vaccinen gives til gravide og ammende kvinder, om end der ikke er foretaget nogen kliniske undersøgelser af vaccinens anvendelse til denne gruppe.
English: The suspension should then be mixed with the buffer solution and drunk within 2 hours.
Danish: Suspensionen skal derefter blandes med bufferopløsningen og drikkes inden for 2 timer.
English: Duration of vaccine protection differed by age, lasting for 6 months in children and for 2 years in adults (see table below).
Danish: Varigheden af vaccinens beskyttelse varierede efter alder: 6 måneder for børn og 2 år for voksne (se nedenstående tabel).
English: For continuous protection against cholera a single booster dose is recommended within 2 years for adults and children from 6 years of age, and within 6 months for children aged 2 to below 6 years.
Danish: For kontinuerlig beskyttelse mod kolera anbefales en enkelt booster-dosis inden for 2 år for voksne og børn fra 6 år og opefter, og inden for 6 måneder for børn i alderen fra 2 til under 6 år.
English: 6 months 1st year 2nd year
Danish: 1. år 2. år
English: What you need to know before you use Dukoral Do not use Dukoral
Danish: Det skal De vide, før De begynder at tage Dukoral Tag ikke Dukoral
English: Drink the entire mixture within 2 hours after mixing with the buffer solution.
Danish: Hele blandingen skal drikkes inden for 2 timer efter opblanding med bufferopløsningen.
English: The effervescent granules should be dissolved in approximately 150 ml of cool water to get the buffer solution.
Danish: Brusegranulatet skal opløses i cirka 150 ml koldt vand for at få bufferopløsningen.
English: The vaccine suspension is filled in a volume of 3 ml in vials (type I glass) with a rubber stopper (bromobutyl rubber) and a screw cap.
Danish: Vaccinesuspensionen er i mængder a 3 ml fyldt i hætteglas (type I-glas) med gummiprop (brombutylgummi) og skruelåg.
English: If more than 6 weeks have elapsed between doses, the primary immunisation course should be re-started.
Danish: Hvis mere end 6 uger er forløbet mellem de enkelte doser, skal det primære immuniseringsforløb startes forfra.
English: Dukoral is presented as a suspension and effervescent granules for oral suspension.
Danish: Dukoral leveres som en suspension og brusegranulat til oral suspension.
English: Following a booster dose 10-12 months after primary immunisation, the protective efficacy during the second year was 60.5% (95%CI: 28,79).
Danish: Efter en booster-dosis 10-12 måneder efter den primære immunisering var den beskyttende effekt i det andet år 60,5% (95% CI: 28, 79).
English: • The other ingredients in the vaccine suspension are sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium chloride and water for injections.
Danish: • Øvrige indholdsstoffer i vaccinesuspensionen: natriumdihydrogenphosphat, dinatriumhydrogenphosphat, natriumchlorid og vand til injektionsvæsker.
English: Do not take other medicine starting 1 hour before until 1 hour after taking the vaccine.
Danish: Tag ikke anden medicin fra 1 time før indtil 1 time efter indtagelse af vaccinen.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Sodium hydrogen carbonate 5.6 g, sachet
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Natriumhydrogencarbonat 5,6 g brev
English: The effervescent granules are white with a raspberry flavour and are supplied in a sachet.
Danish: Brusegranulatet er hvidt med hindbæraroma og leveres i et brev.
English: Other medicines and Dukoral
Danish: Brug af anden medicin sammen med Dukoral
English: • Difficulty in sleeping
Danish: • Søvnbesvær.
English: The effervescent granules should be dissolved in a glass of cool water, and the resulting buffer solution should be mixed with the suspension.
Danish: Brusegranulatet skal opløses i et glas koldt vand, og suspensionen skal blandes med den dermed fremstillede bufferopløsning.
English: The sodium hydrogen carbonate is supplied as effervescent granules, which should be dissolved in a glass of cool water (approx. 150 ml).
Danish: Natriumhydrogencarbonatet leveres som brusegranulat i et brev, der skal opløses i et glas koldt vand (cirka 150 ml).
English: Valneva Sweden AB S-105 21 Stockholm Sweden infodukoral@valneva.com
Danish: Valneva Sweden AB S-105 21 Stockholm Sverige infodukoral@valneva.com
English: Dukoral contains sodium
Danish: Dukoral indeholder natrium
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Dukoral contains approximately 1.1 g sodium per dose.
Danish: Dukoral indeholder ca. 1,1 g natrium pr. dosis.
English: If you had your last dose of vaccine less than 2 years ago a single dose will renew your protection.
Danish: Hvis De har fået Deres sidste dosis af vaccinen mindre end 2 år tidligere, vil en enkelt dosis kunne forny beskyttelsen.
English: No clinical data on protective efficacy of Dukoral against cholera after administration of booster doses are available.
Danish: Der findes ingen kliniske data vedrørende den beskyttende effekt af Dukoral mod kolera efter administration af booster-doser.
English: Dizziness Very rare Drowsiness, insomnia, fainting, reduced sense of taste
Danish: Svimmelhed Meget sjælden Omtågethed, insomni, besvimelse, nedsat smagssans
English: Table: Protective efficacy against cholera in the Bangladesh study (per-protocol analysis) Protective efficacy, % (95% CI) Adults and children >6 year
Danish: Tabel: Beskyttende effekt mod kolera i studiet i Bangladesh (per-protocol-analyse) Beskyttende effekt, % (95% CI) Voksne og børn > 6 år Børn 2-6 år:
English: The anti-toxin intestinal antibodies prevent the cholera toxin from binding to the intestinal mucosal surface thereby preventing the toxin-mediated diarrhoeal symptoms.
Danish: De antitoksine antistoffer i tarmene forhindrer koleratoksinet i at binde til tarmenes slimhindeoverflade og forebygger derved de toksinmedierede symptomer på diaré.
English: Follow up
Danish: Opfølgning
English: • Diarrhoea, stomach pain, stomach cramps, gurgling stomach, bloated stomach, stomach gas and general stomach discomfort
Danish: • Diaré, mavepine, mavekramper, skvulpen i maven, oppustet mave, luft i maven, generelt ubehag i maven
English: Adults and children from 6 years of age: The primary vaccination is 2 doses taken orally (by mouth) at least 1 week (up to 6 weeks) apart.
Danish: Voksne og børn fra 6 år: Den primære vaccination er 2 doser, der skal tages oralt (gennem munden) med mindst 1 uges (og op til 6 ugers) mellemrum.
English: Children 2 to below 6 years of age: half of the buffer solution is poured away and the remaining part (approx. 75 ml) is mixed with the entire contents of the vaccine vial.
Danish: Børn fra 2 til under 6 år: Halvdelen af bufferopløsningen kasseres, og den resterende del (cirka 75 ml) blandes med hele indholdet af hætteglassetmed vaccine.
English: Very rare side effects (may affect up to 1 in a 10,000 people)
Danish: Meget sjældne bivirkninger (kan ramme op til 1 ud af 10.000 personer)
English: This leaflet was last revised in MM/YYYY Other sources of information
Danish: Denne indlægsseddel blev senest ændret MM/ÅÅÅÅ
English: • if you are allergic to any ingredient of the vaccine or to formaldehyde.
Danish: • hvis De er allergisk over for et af indholdsstofferne i vaccinen (angivet i afsnit 6) eller formaldehyd.
English: General disorders and administration site conditions Rare
Danish: Almene symptomer og reaktioner på administrationsstedet Sjælden
English: Children of 2 to below 6 years of age: The primary vaccination is 3 doses taken orally (by mouth) at least 1 week (up to 6 weeks) apart.
Danish: Børn fra 2 til under 6 år: Den primære vaccination er 3 doser, der skal tages oralt (gennem munden) med mindst 1 uges (og op til 6 ugers) mellemrum.
English: Suspension and effervescent granules for oral suspension: - Suspension for oral suspension
Danish: Suspension og brusegranulat til oral suspension: - Suspension til oral suspension.
English: Rare side effects (may affect up to 1 in a 1,000 people)
Danish: Sjældne bivirkninger (kan ramme op til 1 ud af 1.000 personer)
English: Each dose of vaccine is supplied as one vial of suspension together with one sachet of effervescent granules.
Danish: Hver dosis vaccine leveres som et hætteglas med suspension sammen med 1 brev brusegranulat.
English: Protective efficacy of Dukoral against cholera has not been studied following repeated booster vaccination.
Danish: Den beskyttende effekt af Dukoral mod kolera efter gentagelse med en booster-vaccination er ikke undersøgt.
English: In the Bangladesh field trial, protective efficacy of Dukoral in the overall population was 85% (95%CI: 56, 95, per-protocol analysis) for the initial 6 months of follow-up.
Danish: I feltstudier i Bangladesh var den beskyttende effekt af Dukoral i den samlede population 85% (95% CI: 56, 95, Per-protocol-analyse) i de første 6 måneder af opfølgningsperioden.
English: Oral administration of other medicinal products should be avoided within 1 hour before and 1 hour after administration of Dukoral.
Danish: Oral administration af andre præparater bør undgås i 1 time før og 1 time efter administration af Dukoral.
English: Shake the Dukoral® suspension vial (1 vial = 1 dose).
Danish: Hætteglasset med Dukoral® suspension omrystes (1 hætteglas = 1 dosis).
English: In the second trial, conducted in Peru and enrolling military recruits, the short-term protective efficacy against cholera after 2 vaccine doses was 85% (95%CI: 36, 97, per-protocol analysis).
Danish: I det andet studie, der blev gennemført i Peru med deltagelse af rekrutter fra militæret, var den kortsigtede beskyttende effekt mod kolera efter 2 vaccinedoser 85% (95% CI: 36, 97, per-protocolanalyse).
English: Vibrio cholerae O1 Ogawa, classical biotype (formalin inactivated) 31.25x109 bacteria*
Danish: Vibrio cholerae O1 Ogawa, klassisk biotype (formalin-inaktiveret) 31,25x109 bakterier*
English: Dukoral is taken orally with bicarbonate buffer, which protects the antigens from the gastric acid.
Danish: Dukoral administreres oralt med bicarbonatbuffer, som beskytter antigenerne mod mavesyre.
English: • The effervescent granules contain sodium hydrogen carbonate, citric acid, sodium carbonate, saccharin sodium, sodium citrate and raspberry flavour.
Danish: • Brusegranulatet indeholder natriumhydrogencarbonat, citronsyre, natriumcarbonat, saccharinnatrium, natriumcitrat og hindbæraroma.
English: For children of 2 to below6 years: pour away half of the buffer solution.
Danish: Til børn i alderen fra 2 til under 6 år: Halvdelen af bufferopløsningen kasseres.
English: No preclinical safety testing with the vaccine has been conducted.
Danish: Det er ikke foretaget nogen undersøgelse af de prækliniske sikkerhedsdata for vaccinen.
English: In the longitudinal cohort-analysis conducted during the mass-vaccination campaign in Zanzibar, protective effectiveness after 2 doses of Dukoral was 79% (95% CI, 47, 92) for a follow-up period of 15 months.
Danish: I den longitudinelle kohorteanalyse, der blev gennemført i forbindelse med massevaccinationskampagnen i Zanzibar, var den beskyttende virkning efter 2 doser Dukoral 79% (95% CI 47-92) for en opfølgningsperiode på 15 måneder.
English: Children 2 to below 6 years of age: half of the buffer solution is poured away and the remaining part (approx. 75 ml) is mixed with the entire contents of the vial.
Danish: Børn fra 2 til under 6 år: Halvdelen af bufferopløsningen kasseres, og den resterende del (cirka 75 ml) blandes med al suspensionen i hætteglasset.
English: However, immunological and duration of protection data suggest that if up to 2 years have elapsed since the last vaccination for adults and up to 6 months for children aged 2 to below 6 years a single booster dose should be given.
Danish: Immunologiske data og data vedrørende varigheden af beskyttelse tyder dog på, at en enkelt booster-dosis bør gives, hvis der er forløbet op til 2 år siden seneste vaccination for voksne og op til 6 måneder for børn i alderen fra 2 til under 6 år.
English: 20x1 dose.
Danish: 20x1 dosis.
English: The suspension is a whitish suspension supplied in a vial.
Danish: Suspensionen er en hvidlig suspension i et hætteglas.