FrancophonIA/ELRC3.0 huggingface dataset:
English: To avoid the risk of potentially life-threatening air or gas embolism EVICEL should be sprayed using pressurized CO2 gas only (see table below).
Danish: For at undgå risiko for potentielt livstruende luft- eller gasemboli må EVICEL kun sprayes på ved hjælp af CO2-gas under tryk (se nedenstående skema).
English: 1 vial containing 5 ml of human clottable protein 1 vial containing 5 ml of human thrombin
Danish: 1 hætteglas indeholdende 5 ml humant koagulerbart protein 1 hætteglas indeholdende 5 ml humant trombin
English: EVICEL is intended for epilesional use only.
Danish: EVICEL er udelukkende beregnet til anvendelse på læsioner.
English: 1 vial containing 2 ml human clottable protein 1 vial containing 2 ml of human thrombin
Danish: 1 hætteglas indeholdende 2 ml humant koagulerbart protein 1 hætteglas indeholdende 2 ml humant trombin
English: Intracranial hypotension (CSF leakage)
Danish: Intrakraniel hypotension (lækage af cerebrospinalvæske) Cerebrospinalvæske-rinoré Hovedpine
English: Signs of such reactions include hives, rash, tightness of the chest, wheezing, drop in blood pressure and anaphylaxis.
Danish: Tegn på sådanne reaktioner kan være nældefeber, udslæt, sammensnøret bryst, hiven efter vejret, blodtryksfald og anafylaksi.
English: 1 vial containing 1 ml of human clottable protein 1 vial containing 1 ml of human thrombin
Danish: 1 hætteglas indeholdende 1 ml humant koagulerbart protein 1 hætteglas indeholdende 1 ml humant trombin
English: Most serious side effects - Watery fluid coming out of your wound or nose (CSF leakage/CSF rhinorrhea) - Headache, nausea, and vomiting (due to Subdural Hygroma, which is accumulation of CSF in the subdural space) - Fever, or prolonged constipation, flatulence (due to abdominal abscess)
Danish: - Hovedpine, kvalme og opkastning (grundet subduralt hygrom, som er ophobning af cerebrospinalvæske (hjernevæske) under den hårde hjernehinde) - Feber, længerevarende forstoppelse, luft i maven (på grund af byld i maven)
English: EVICEL is a fibrin sealant.
Danish: EVICEL er en vævsklæber med fibrin fra mennesker.
English: Adverse reactions - vascular surgery
Danish: Bivirkninger - karkirurgi
English: Each contains 1 ml, 2 ml or 5 ml solution of human fibrinogen and human thrombin, respectively.
Danish: Det leveres i en pakning med to hætteglas, der hver indeholder 1 ml, 2 ml eller 5 ml opløsning (henholdsvis humant fibrinogen og humant trombin).
English: To avoid the risk of potentially life-threatening air or gas embolism EVICEL should be sprayed using pressurised CO2 gas only.
Danish: For at undgå risikoen for potentielt livstruende luft- eller gasemboli må EVICEL kun påsprøjtes ved brug af CO2-gas under tryk.
English: Meningitis
Danish: Dosering
English: - Numbness or pain in your extremities, change in skin colour (due to Graft Occlusion or Thrombosis) The frequency of this effect was uncommon (may affect up to 1 in 100 people).
Danish: - Følelsesløshed eller smerter i lemmerne, ændring i hudfarve (på grund af tilstopning af stent eller blodprop)
English: Haematoma
Danish: Natriumcitrat
English: Do not apply intravascularly
Danish: Må ikke anvendes intravaskulært.
English: Component 1: Human clottable protein containing mainly fibrinogen and fibronectin (50 - 90 mg/ml) Component 2: Human thrombin (800 - 1,200 IU/ml)
Danish: Komponent 1: Humant koagulerbart protein indeholder hovedsageligt fibrinogen og fibronectin (50-90 mg/ml)
English: Once drawn up into the application device, they must be used immediately.
Danish: Skal anvendes straks, når det er opsuget i applikatoren.
English: Component 1: 1 vial containing 5 ml of human clottable protein (50 - 90 mg/ml) Component 2: 1 vial containing 5 ml of human thrombin (800 - 1200 IU/ml).
Danish: Komponent 1: 1 hætteglas indeholdende 5 ml humant koagulerbart protein (50-90 mg/ml) Komponent 2: 1 hætteglas indeholdende 5 ml humant trombin (800-1.200 IE/ml).
English: To avoid the risk of potentially life-threatening air or gas embolism EVICEL should be sprayed using pressurised CO2 only.
Danish: For at undgå risikoen for potentielt livstruende luft-eller gasemboli må EVICEL kun sprayes ved brug af CO2 under tryk.
English: o requirement to dry the wound using standard techniques (e.g., intermittent application of compresses, swabs, use of suction devices) prior to using the product o requirement to closely monitor blood pressure, pulse rate, oxygen saturation, and end tidal CO2 when spraying the product, for the occurrence of gas embolism.
Danish: • Undervisningsmateriale til sundhedspersonale skal informere om o risiko for livstruende gasemboli, hvis produktet sprayes forkert o udelukkende brug af CO2 under tryk o begrænsning til åben og laparoskopisk kirurgi, minimum-spray-afstande skal overholdes: åben kirurgi - minimum 10 cm laparoskopisk kirurgi - minimum 4 cm, hvis spray-afstanden kan bedømmes nøjagtigt o korrekt tryk og afstand til væv afhængigt af operationstype (åben eller laparoskopisk) o krav om at tørre såret ved brug af standardteknikker (f.eks. intermitterende applikation af kompres, tamponerbrug af sugeanordninger), før produktet anvendes o krav om tæt monitorering af blodtryk, puls, iltmætning og slut-tidal-CO2 under sprayning af produktet for forekomst af gasemboli o hvilke(n) regulator(er), der skal anvendes, i overensstemmelse med producentens anbefalinger og brugsanvisningen i produktresumeet
English: EVICEL solutions for sealant
Danish: EVICEL vævsklæber, opløsninger
English: Component 1: 1 vial containing 1 ml of human clottable protein (50 - 90 mg/ml) Component 2: 1 vial containing 1 ml of human thrombin (800 - 1200 IU/ml).
Danish: Komponent 1: 1 hætteglas indeholdende 1 ml humant koagulerbart protein (50-90 mg/ml) Komponent 2: 1 hætteglas indeholdende 1 ml humant trombin (800-1.200 IE/ml).
English: Component 1: 1 vial containing 2 ml of human clottable protein (50 - 90 mg/ml) Component 2: 1 vial containing 2 ml of human thrombin (800 - 1200 IU/ml).
Danish: Komponent 1: 1 hætteglas indeholdende 2 ml humant koagulerbart protein (50-90 mg/ml) Komponent 2: 1 hætteglas indeholdende 2 ml humant trombin (800-1.200 IE/ml).
English: Evicel is for epilesional use.
Danish: Evicel er til anvendelse på læsioner.
English: 35 cm rigid tip
Danish: 35 cm stiv spids
English: EVICEL is for epilesional use only.
Danish: EVICEL er kun til anvendelse på læsioner.
English: Adverse reactions in vascular surgery study Infections and infestations
Danish: Bivirkninger rapporteret i forbindelse med vaskulær kirurgi studie Infektioner og parasitære sygdomme Graftinfektion, stafylokokinfektion Ikke almindelig Vaskulære sygdomme
English: • To avoid the risk of potentially fatal air or gas embolism EVICEL should be sprayed using pressurised CO2 gas only.
Danish: • For at undgå risikoen for en mulig dødelig luft- eller gasemboli (luftbobler i blodet) må EVICEL kun sprayes på ved brug af CO2-gas.
English: 10 - 15 cm (4 - 6 in)
Danish: 4-10 cm
English: Signs of allergic reactions include hives, rash, tightness of the chest, wheezing, drop in blood pressure, and breathing difficulties.
Danish: Nældefeber, udslæt, trykken i brystet, hiven efter vejret, blodtryksfald og vejrtrækningsproblemer kan være tegn på overfølsomhedsreaktioner.
English: When spraying EVICEL, changes in blood pressure, pulse, oxygen saturation and end tidal CO2 should be monitored because of the possibility of occurrence of gas embolism.
Danish: Ved påføring af EVICEL bør ændringer i blodtryk, puls, iltmætning og slut-tidal CO2 monitoreres på grund af muligheden for forekomst af gasembolisme.
English: When spraying EVICEL, changes in blood pressure, pulse, oxygen saturation, and end tidal CO2 should be monitored because of the possibility of occurrence of air or gas embolism.
Danish: Ved påføring af EVICEL bør ændringer i blodtryk, puls, iltmætning og slut-tidal CO2 monitoreres på grund af muligheden for forekomst af lufteller gasembolisme.
English: Keep upright.
Danish: Opbevares opretstående.
English: What EVICEL looks like and contents of the pack
Danish: EVICELS udseende og pakningsstørrelse
English: Preparation
Danish: Klargøring
English: Do not use any other liquid.
Danish: Brug ikke nogen anden væske.
English: Date of first authorisation: 28 April 2004 Date of latest renewal: 25 March 2009
Danish: Dato for første markedsføringstilladelse: 28. april 2004 Dato for seneste fornyelse: 25. marts 2009
English: Chlorinated water can be used.
Danish: Kloreret vand kan anvendes.
English: Number (Age groups)
Danish: Antal (aldersgruppe)
English: Contact a doctor immediately if you experience the following serious side effects:
Danish: Kontakt straks en læge, hvis De får følgende alvorlige bivirkninger:
English: Efficacy against cholera
Danish: Effektivitet over for kolera
English: In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose
Danish: I henhold til artikel 114 i direktiv 2001/83/EF foretages den officielle batchfrigivelse af et statsligt laboratorium eller et laboratorium udpeget hertil.
English: Other side effects (frequency cannot be estimated from the available data)
Danish: Andre bivirkninger (hyppigheden kan ikke vurderes ud fra tilgængelige data)
English: Peru, military
Danish: Peru, militær
English: Using Dukoral with food and drink
Danish: Brug af Dukoral sammen med mad og drikke
English: Dukoral should not replace standard protective measures.
Danish: Dukoral må ikke erstatte beskyttende standardforanstaltninger.
English: Data on overdose are limited.
Danish: Data vedrørende overdosering er begrænsede.
English: Active substances: 1 dose contains
Danish: Aktive stoffer: 1 dosis indeholder
English: 1 dose (3 ml)
Danish: 1 dosis (3 ml)
English: Each dose of vaccine suspension (3 ml) contains:
Danish: Hver dosis vaccinesuspension (3 ml) indeholder:
English: Children less than 2 years
Danish: Børn under 2 år
English: In the event of diarrhoea measures of rehydration should be instituted.
Danish: I tilfælde af diaré skal foranstaltninger til rehydrering iværksættes.
English: In the majority of studies adverse events were assessed by passive surveillance.
Danish: I de fleste af studierne blev bivirkningerne vurderet ved hjælp af passiv overvågning.
English: During a mass-vaccination campaign conducted in Zanzibar, 196 pregnant women had received at least one dose of Dukoral.
Danish: Under en massevaccinationskampagne, der blev gennemført i Zanzibar, fik 196 gravide kvinder mindst én dosis Dukoral.
English: Over 94,000 doses of Dukoral were administered during the clinical trials.
Danish: Mere end 94.000 doser Dukoral blev indgivet under de kliniske studier.
English: Read all of this leaflet carefully before you start using this vaccine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden De begynder at tage vaccinen, da den indeholder vigtige oplysninger.
English: At the end of this period the product should be used or discarded.
Danish: Efter denne periode skal præparatet anvendes eller kasseres.
English: Immunisation should be completed at least 1 week prior to potential exposure to V. cholerae O1.
Danish: Immuniseringen skal være fuldført mindst 1 uge inden en potentiel eksponering for V. cholerae O1.
English: Formaldehyde is used during the manufacturing process and trace amounts may be present in the final product.
Danish: Der er anvendt formaldehyd i fremstillingsprocessen, og spormængder kan forekomme i det færdige produkt.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene til fremsendelse af periodiske, opdaterede sikkerhedsberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD-list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: In addition to the direct protection, it was shown that Dukoral provides significant indirect (herd) protection in the studied setting.
Danish: Udover den direkte beskyttelse blev det vist, at Dukoral yder betydelig indirekte beskyttelse (flokbeskyttelse) i det undersøgte miljø.
English: Cholera Bangladesh 1985-88 3 doses at 6 week intervals
Danish: Kolera Bangladesh 1985-88 3 doser med 6 ugers interval
English: • if you take a medical treatment that affects the immune system
Danish: • hvis De tager et lægemiddel, der påvirker immunsystemet
English: Evaluation of safety varied between trials with respect to mode of surveillance, definition of symptoms and time of follow-up.
Danish: Vurderingen af sikkerheden varierede fra studie til studie for så vidt angår overvågningsmetode, symptomdefinition samt tidspunkt for opfølgning.
English: The third study, a field trial conducted in Peru, failed to show any protective efficacy against cholera during the first year.
Danish: Det tredje studie, et feltstudie, der blev gennemført i Peru, viste ingen beskyttende effekt mod kolera i det første år.
English: Drink the entire mixture within 2 hours.
Danish: Drik hele blandingen inden for 2 timer.
English: Food and/or drink will increase acid production in the stomach and the effect of the vaccine may be impaired.
Danish: Indtagelse af føde- og/eller drikkevarer vil forøge syreproduktionen i maven, og vaccinens effekt kan derved forringes.
English: Therefore, Dukoral is not recommended to be used in children less than 2 years of age.
Danish: Derfor anbefales det ikke, at Dukoral anvendes til børn under 2 år.
English: However, an effectiveness study in a population with high HIV prevalence showed similar protection as in other populations.
Danish: Et studie til undersøgelse af effekt i en population med høj hiv-forekomst viste dog en beskyttelse på niveau med den i andre populationer.
English: The two toxins cross-react immunologically.
Danish: De to toksiner krydsreagerer immunologisk.
English: There are only very limited data on protective efficacy of the vaccine in subjects aged 65 years and more.
Danish: Der er kun meget begrænsede data vedrørende vaccinens beskyttende effekt hos personer på 65 år og derover.
English: Do not give this vaccine to children younger than 2 years since the protection has not been studied in this group.
Danish: Denne vaccine må ikke gives til børn under 2 år, da beskyttelsen ikke er undersøgt i denne gruppe.
English: Only half of the amount of the buffer solution should be mixed with the vaccine.
Danish: Kun halvdelen af bufferopløsningen skal blandes med vaccinen.
English: Like all medicines, Dukoral can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: 1994 2 doses 7-11 days apart
Danish: 1994 2 doser med 7-11 dages interval
English: The vaccine may provide you with a lower level of protection than it does for people with healthy immune systems.
Danish: Vaccinen kan give Dem et lavere beskyttelsesniveau, end det giver personer med et rask immunsystem.
English: The use of Dukoral should be determined on the basis of official recommendations taking into consideration the variability of epidemiology and the risk of contracting disease in different geographical areas and travelling conditions.
Danish: Beslutningen om at anvende Dukoral skal træffes på baggrund af de officielle anbefalinger og under hensyntagen til den epidemiologiske foranderlighed samt risikoen for at pådrage sig sygdom i forskellige geografiske områder og under forskellige rejsebetingelser.
English: • serious allergic reactions causing swelling of the face or throat and breathlessness
Danish: • alvorlige allergiske reaktioner, der medfører hævelse i ansigt eller hals samt åndedrætsbesvær
English: The number of patients enrolled, dosage regimens and follow-up periods are shown in the following table.
Danish: Antal deltagende personer, doseringsregimer samt opfølgningsperioder er vist i nedenstående tabel.
English: Locally produced secretory IgA antibodies in the intestine probably mediate protective immunity.
Danish: Lokalt producerede sekretoriske IgA-antistoffer i intestina medierer sandsynligvis en beskyttende immunitet.
English: (18-65 years)
Danish: (18-65 år)
English: 31.25x109 bacteria*
Danish: 31,25x109 bakterier*
English: * Bacterial count before inactivation.
Danish: *bakterieindhold inden inaktivering
English: • if you have a disease of the immune system (including HIV infection).
Danish: • hvis De har en sygdom i immunsystemet (f.eks. hiv-infektion).
English: There was no statistically significant evidence of a harmful effect of Dukoral exposure during pregnancy.
Danish: Der var ingen statistisk signifikant evidens for en skadelig virkning af eksponering for Dukoral under graviditet.
English: DUKORAL suspension Oral use.
Danish: DUKORAL suspension Oral anvendelse.
English: If you are pregnant, think you may be pregnant or are planning to have a baby or are breast-feeding, ask your doctor before taking the vaccine.
Danish: Hvis De er gravid eller ammer, har mistanke om, at De er gravid eller planlægger at blive gravid, skal De spørge Deres læge til råds, før De tager vaccinen.
English: Doses are to be administered at intervals of at least one week.
Danish: Doserne skal indgives med intervaller på mindst 1 uge.
English: The duration of the immunological memory was estimated to last for at least 2 years in adults.
Danish: Den immunologiske hukommelses varighed blev vurderet til at være mindst 2 år for voksne.
English: No other vaccines/ medicinal products, including oral polio vaccine and antimalarials, have been given simultaneously with Dukoral in clinical studies.
Danish: Ingen andre vacciner/lægemidler, herunder oral poliovaccine og malariamidler, er blevet givet samtidig med Dukoral i kliniske undersøgelser.
English: Immunisation does not protect against V. cholerae serogroup O139 or other species of Vibrio.
Danish: Immuniseringen beskytter ikke mod V. cholerae serogruppe O139 eller andre arter af Vibrio.
English: Dukoral has been given to children between 1 and 2 years of age in safety and immunogenicity studies, but the protective efficacy has not been studied in this age group.
Danish: Dukoral er givet til børn i alderen 1 til 2 år i undersøgelser af sikkerheden og immunogeniciteten, men den beskyttende effekt er endnu ikke undersøgt i denne aldersgruppe.
English: − A total of 1.25x1011 bacteria of the following strains:
Danish: − I alt 1,25x1011 bakterier af følgende stammer:
English: • if you have an acute stomach disorder or infection with fever (vaccination should be delayed).
Danish: • hvis De lider af akut mavesygdom eller infektion med feber (vaccinationen skal så udsættes).
English: Serum vibriocidal antibodies against the bacterial components were seen in 35-55% of vaccinated subjects and antitoxic antibodies in 78-87% of vaccinated subjects.
Danish: Vibriocide antistoffer i serum mod de bakterielle komponenter blev set hos 35-55% af de vaccinerede personer og antitoksiske antistoffer hos 78-87% af de vaccinerede personer.
English: The vaccine is intended for oral use.
Danish: Vaccinen er beregnet til oral anvendelse.
English: The heat-labile toxin (LT) of enterotoxigenic E. coli (ETEC ) is structurally, functionally and immunologically similar to CTB.
Danish: Det varmelabile toksin (LT) af enterotoksigen E. coli (ETEC) ligner CTB strukturelt, funktionelt og immunologisk.
English: Protective effectiveness against cholera was evaluated during two mass-vaccination campaigns conducted in Mozambique (December 2003 - January 2004) and Zanzibar (February 2009 - May
Danish: Den beskyttende virkning mod kolera blev undersøgt i forbindelse med to massevaccinationskampagner, der blev gennemført i Mozambique (december 2003 til januar 2004) og Zanzibar (februar 2009 til maj 2010).
English: EU/1/03/263/001 1 dose EU/1/03/263/002 2x1 dose EU/1/03/263/003 20x1 dose
Danish: EU/1/03/263/001 1 dosis EU/1/03/263/002 2x1 dosis EU/1/03/263/003 20x1 dosis
English: Product in the unopened vial and sachet, stored in the outer carton, is stable at temperatures up to 25oC for a period of 14 days.
Danish: I uåbnet hætteglas og brev og opbevaret i den ydre karton er præparatet stabilt ved temperaturer op til 25oC i en periode på 14 dage.
English: 1993-95 2 doses 2 weeks apart with a booster dose 1 year later
Danish: 1993-95 2 doser med 2 ugers interval og en booster-dosis 1 år efter
English: Pharmacotherapeutic group: Bacterial vaccines, ATC-code: J07AE01
Danish: Farmakoterapeutisk klassifikation: Bakterielle vacciner, ATC-kode: J07AE01
English: Antibody response in vaccinees with endogenous or iatrogenic immunosuppression may be insufficient.
Danish: Antistofrespons hos vaccinerede personer med endogen eller iatrogen immunsuppression kan være utilstrækkelig.
English: Bacterial strains of both Inaba and Ogawa serotypes and of El Tor and Classical biotypes are included in the vaccine.
Danish: Bakteriestammer af både Inaba og Ogawa serotyper samt af El Tor og klassiske biotyper er indeholdt i vaccinen.
English: An exploratory analysis suggested that 2 vaccine doses seemed as effective as 3 doses in adults.
Danish: En forberedende analyse indikerede, at 2 vaccinedoser var lige så effektive som 3 vaccinedoser til voksne.
English: (2-65 years)
Danish: (2-65 år)
English: The vaccine induced intestinal antitoxin IgA responses in 70-100% of vaccinated subjects.
Danish: Vaccinen inducerede antitoksine IgA-reaktioner i intestina hos 70-100% af de vaccinerede personer.
English: The vaccine acts by inducing antibodies against both the bacterial components and CTB.
Danish: Vaccinen virker ved at inducere antistoffer mod både de bakterielle komponenter og CTB.
English: The vaccine protects adults and children from 2 years of age against cholera.
Danish: Vaccinen beskytter voksne og børn fra 2-års-alderen mod kolera.
English: Dukoral contains approximately 1.1 g sodium per dose, which should be taken into consideration by patients on a controlled sodium diet.
Danish: Dukoral indeholder ca. 1,1 g natrium pr. dosis, hvilket der skal tages højde for hos patienter på en kontrolleret natriumdiæt.
English: - suspension for oral suspension:
Danish: - suspension til oral suspension:
English: The immune response to live typhoid vaccine was not investigated in this study.
Danish: Immunreaktionen på levende tyfusvaccine blev ikke undersøgt i denne undersøgelse.
English: If you forget to take Dukoral.
Danish: Hvis De har glemt at tage Dukoral
English: Adverse reactions reported are consistent with those seen after the recommended dosing.
Danish: De indberettede bivirkninger svarer til dem, der ses efter den anbefalede dosering.
English: Dukoral confers protection specific to Vibrio cholerae serogroup O1.
Danish: Dukoral giver beskyttelse specifikt mod Vibrio cholerae serogruppe O1.
English: No animal data on reproduction toxicity are available.
Danish: Der findes ingen data fra dyrestudier vedrørende reproduktionstoksiciteten.
English: • High blood pressure
Danish: • Forhøjet blodtryk.
English: (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Klassificering af hyppighed: Meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: 2D barcode carrying the unique identifier included.
Danish: Der er anført en 2D-stregkode, som indeholder en unik identifikator.
English: Immunisation of HIV infected subjects could result in transient increases of viral load.
Danish: Immunisering af HIV-inficerede personer kan medføre midlertidige stigninger i virusmængden.
English: Talk to your doctor before taking Dukoral
Danish: Kontakt lægen, før De tager Dukoral