FrancophonIA/ELRC3.0 huggingface dataset:
English: 6 to 11 months of age
Danish: Aldersgruppe 6 til 11 måneder
English: Serum bactericidal antibody responses at 1 month following the third dose of Bexsero given at 2, 3, 4 or 2, 4, 6 months of age
Danish: Serum-baktericidt antistofrespons en måned efter den tredje dosis Bexsero givet i 2-, 3- og 4- eller 2-, 4- og 6-måneders-alderen
English: When given concomitantly with other vaccines Bexsero must be administered at separate injection sites (see section 4.2).
Danish: Ved administration samtidig med andre vacciner skal vaccinerne administreres på separate injektionssteder (se pkt.
English: Injection site reactions like extensive swelling of the vaccinated limb, blisters at or around the injection site and hard lump at the injection site (which may persist for more than one month).
Danish: Reaktioner på injektionsstedet med omfattende hævelse af den/det vaccinerede arm/ben, blærer på eller omkring injektionsstedet og en hård knude på injektionsstedet (som kan være tilstede i mere end en måned).
English: Bexsero suspension for injection in pre-filled syringe Meningococcal group B Vaccine (rDNA, component, adsorbed)
Danish: Bexsero injektionsvæske, suspension i fyldt injektionssprøjte Meningokok gruppe B-vaccine (rDNA, komponent, adsorberet)
English: Not known: fever, injection site reactions (including extensive swelling of the vaccinated limb, blisters at or around the injection site and injection site nodule which may persist for more than one month)
Danish: Ikke kendt: feber, reaktioner på injektionsstedet (herunder omfattende hævelse af den/det vaccinerede arm/ben, blærer på eller omkring injektionsstedet og noduli ved injektionsstedet, som kan være tilstede mere end en måned).
English: There was no evidence of maternal or foetal toxicity, and no effects on pregnancy, maternal behaviour, female fertility, or postnatal development in a study in which female rabbits received Bexsero at approximately 10 times the human dose equivalent based on body weights.
Danish: I et studie, hvor hunkaniner fik Bexsero ækvivalent til ca. ti gange den humane dosis baseret på kropsvægt, fandtes ingen tegn på maternel eller føtal toksicitet og ingen effekt på graviditet, maternel adfærd, fertilitet hos hundyr eller postnatal udvikling.
English: Not known: injection site reactions (including extensive swelling of the vaccinated limb, blisters at or around the injection site and injection site nodule which may persist for more than one month)
Danish: Ikke kendt: reaktioner på injektionsstedet (herunder omfattende hævelse af den/det vaccinerede arm/ben, blærer på eller omkring injektionsstedet og noduli ved injektionsstedet, som kan være tilstede mere end en måned).
English: Even if you or your child have been vaccinated with Bexsero you or your child remain at increased risk of disease caused by the Neisseria meningitidis group B bacteria.
Danish: Selvom du eller dit barn er blevet vaccineret med Bexesro, er du og dit barn stadig i øget risiko for sygdom forårsagt af Neisseria meningitidis bakterien gruppe B. - hvis dit barn er født for tidligt (før eller ved 28. uge af graviditeten), især hvis barnet havde vejrtrækningsproblemer.
English: Bexsero (0.5 ml) will be given to you or your child by a doctor or nurse.
Danish: Bexsero (0,5 ml) gives til dig eller dit barn af lægen eller sundhedspersonalet.
English: Fever (adolescents from 11 years of age and adults).
Danish: Feber (unge fra 11 år og opefter, og voksne)
English: Adolescents (from 11 years of age) and adults
Danish: Unge (fra 11 år) og voksne
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Hjælpestoffer Natriumchlorid
English: - A booster will be given after an interval of 12 to 23 months from the second injection.
Danish: - Intervallet mellem injektionerne skal være mindst 2 måneder - Boosteren gives med et interval på mellem 12 til 23 måneder efter den anden injektion.
English: ** % seropositive = the percentage of subjects who achieved an hSBA ≥ 1:5.
Danish: ** % seropositive = procentdel af forsøgspersoner, der opnåede hSBA ≥1:5.
English: Infants 6 months to 11 months of age at the time of first dose
Danish: Spædbørn fra 6 til 11 måneder på tidspunktet for første dosis
English: * % seropositive = the percentage of subjects who achieved an hSBA ≥ 1:4.
Danish: * % seropositive = procentdelen af forsøgspersoner, der opnåede hSBA ≥1:4.
English: Serum bactericidal antibody responses at 1 month following the second dose of Bexsero given to children 2-10 years of age following a 0, 1-month schedule
Danish: Serum-bactericidt antistofrespons 1 måned efter den anden dosis af Bexsero givet til børn i alderen 2-10 år, efter et 0, 1-månedes-regime.
English: Age at first dose Primary Immunisation
Danish: Sammendrag af dosering Alder ved første dosis
English: Musculoskeletal and connective tissue disorders Very common: arthralgia
Danish: Knogler, led, muskler og bindevæv Meget almindelige: artralgi
English: Serum bactericidal antibody responses at 1 month following the second dose of Bexsero given to children 2-10 years of age following a 0, 2-month schedule
Danish: Serum-bactericidt antistofrespons 1 måned efter anden dosis af Bexsero givet til børn i alderen 2-10 år, efter et 0, 2-måneders-regime
English: Bexsero is given to individuals from 2 months of age and older to help protect against disease caused by the Neisseria meningitidis group B bacteria.
Danish: Bexsero er indiceret til aktiv immunisering af personer i alderen fra 2 måneder og derover mod invasiv meningokoksygdom forårsaget af Neisseria meningitidis gruppe B.
English: pre-vaccination titer ≥1:4
Danish: præ-vaccinationstiter præ-vaccinationstiter
English: NAME OF THE MEDICINAL PRODUCT Bexsero suspension for injection in pre-filled syringe Meningococcal group B Vaccine (rDNA, component, adsorbed)
Danish: Indlægsseddel: Information til brugeren Bexsero injektionsvæske, suspension i fyldt injektionssprøjte Meningokok gruppe B-vaccine (rDNA, komponent, adsorberet)
English: These bacteria can cause serious, and sometimes life-threatening, infections such as meningitis (inflammation of the covering of the brain and spinal cord) and sepsis (blood poisoning).
Danish: Bexsero gives til personer fra 2-måneders-alderen og derover til at hjælpe med at beskytte mod sygdom forårsaget af bakterien Neisseria meningitidis gruppe B. Denne bakterie kan forårsage alvorlige og til tider livstruende infektioner som meningitis (betændelse i hjernehinden og rygmarven) og sepsis (blodforgiftning).
English: Side effects that have been reported during marketed use include:
Danish: Følgende bivirkninger er forekommet, efter vaccinen kom på markedet:
English: Gastrointestinal disorders Very common: nausea
Danish: Mave-tarm-kanalen Meget almindelige: kvalme
English: Talk to your doctor or nurse first.
Danish: Tal med lægen eller sundhedspersonalet før du bruger dette lægemiddel.
English: Bexsero is indicated for active immunisation of individuals from 2 months of age and older against invasive meningococcal disease caused by Neisseria meningitidis group B. The impact of invasive disease in different age groups as well as the variability of antigen epidemiology for group B strains in different geographical areas should be considered when vaccinating.
Danish: Ved vaccination skal der tages hensyn til betydningen af invasiv sygdom i forskellige aldersgrupper og de lokale epidemiologisk geografiske variationer i gruppe B-stammers antigensammensætning.
English: % seropositive (95% CI) hSBA GMT (95% CI) 18-23 months after 2nd dose
Danish: % seropositive (95 % CI) hSBA GMT (95 % CI) 18-23 måneder efter 2. dosis
English: % seropositive* (95% CI) hSBA GMT** (95% CI) 18-23 months after 2nd dose
Danish: % seropositive* (95 % CI) hSBA GMT** (95 % CI) 18-23 måneder efter 2. dosis
English: Recombinant Neisseria meningitidis group B fHbp fusion protein 1, 2, 3
Danish: Rekombinant Neisseria meningitidis gruppe B fHbp-fusionsprotein 1, 2, 3
English: 12 months after booster % seropositive (95% CI) hSBA GMT (95% CI)
Danish: 12 måneder efter booster % seropositive (95 % CI) hSBA-GMT (95 % CI)
English: % seropositive* (95% CI) hSBA GMT** (95% CI) 12 months after 2nd dose
Danish: % seropositive* (95 % CI) hSBA-GMT** (95 % CI) 12 måneder efter anden dosis
English: GlaxoSmithKline GmbH & Co. KG Tel: +49 (0)89 36044 8701 de.impfservice@gsk.com
Danish: KG Tel: +49 (0)89 36044 8701 de.impfservice@gsk.com
English: % seropositive (95% CI) hSBA GMT (95% CI) 12 months after 2nd dose
Danish: % seropositive (95 % CI) hSBA-GMT (95 % CI) 12 måneder efter anden dosis
English: Recombinant Neisseria meningitidis group B NHBA fusion protein 1, 2, 3
Danish: Rekombinant Neisseria meningitidis gruppe B NHBA-fusionsprotein 1, 2, 3
English: 1 month after booster % seropositive (95% CI) hSBA GMT (95% CI)
Danish: En måned efter booster % seropositive (95 % CI) hSBA-GMT (95 % CI)
English: Adolescents received two doses of Bexsero with one, two or six month intervals between doses; these data are summarised in Tables 7 and 8.
Danish: Unge modtog to doser Bexsero med en, to eller seks måneders mellemrum mellem doserne.
English: Infants, 2 months to 5 months a
Danish: Spædbørn, 2 til 5 månedera
English: The vaccination schedules of two doses administered with an interval of one or two months showed similar immune responses in both adults and adolescents.
Danish: Immunresponset var sammenligneligt hos voksne og unge ved anvendelse af to-dosis-vaccinationsprogrammer administreret med et interval på en eller to måneder.
English: % 4-fold increase after 2nd dose
Danish: % firedobbelt stigning efter 2. dosis (95 % CI)
English: Recombinant Neisseria meningitidis group B NadA protein 1, 2, 3
Danish: Rekombinant Neisseria meningitidis gruppe B NadA-protein 1, 2, 3
English: % seropositive* after 2nd dose
Danish: % seropositive* efter 2. dosis (95 % CI)
English: pre-booster % seropositive (95% CI) hSBA GMT (95% CI)
Danish: præbooster % seropositive (95 % CI) hSBA-GMT (95 % CI)
English: At approximately 4 years after the two-dose primary series, the percentages of subjects with hSBA ≥ 1:5 generally declined from a range across strains of 68% to 100% after the second dose to a range across strains of 9% to 84%.
Danish: generelt fra et interval på tværs af stammer på 68 % til 100 % efter anden dosis, til et interval på tværs af stammer på 9 % til 84 %.
English: If you have any further questions on Bexsero, ask your doctor or nurse.
Danish: Spørg lægen eller sundhedspersonalet, hvis der er noget, du er i tvivl om vedrørende Bexsero.
English: The company who applied is Novartis Europharm Limited.
Danish: Firmaet, der har indgivet ansøgningen, er Novartis Europharm Limited.
English: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea.eu.int http://www.emea.eu.int©EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Danish: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
English: International Non-proprietary Name (INN): tegaserod
Danish: Internationalt fællesnavn (INN): tegaserod
English: Treatments were double blinded (neither the patients nor the doctors knew which treatment had been given until the end of the study).
Danish: Behandlingerne var dobbeltblindet (dvs. hverken patienterne eller lægerne vidste, hvilken behandling der var blevet givet, før undersøgelsen var afsluttet).
English: European Medicines Agency Post-authorisation Evaluation of Medicines for Human Use
Danish: European Medicines Agency
English: These effects are expected to relieve the symptoms described.
Danish: Disse virkninger forventes at mildne de beskrevne symtomer.
English: What is Zelnorm?
Danish: Hvad er Zelnorm?
English: They also potentially reduce the sensitivity of the bowel.
Danish: Muligvis mindsker de også tarmens følsomhed.
English: The effects of Zelnorm were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Zelnorm er først testet i forsøgsmodeller, inden de er undersøgt hos mennesker.
English: If you are in a Zelnorm clinical trial for irritable bowel syndrome or any other indication under development and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse med Zelnorm til irritabel tyktarmssyndrom eller en anden indikation, der er ved at blive udformet, og du har behov for flere oplysninger om din behandling, bedes du kontakte den læge, der giver dig behandlingen.
English: It activates receptors in the body, known as 5-hydroxytryptamine (5HT) type 4 receptors.
Danish: I kroppen aktiverer den nogle receptorer, der kaldes 5-hydroxytryptamin (5HT) type 4-receptorer.
English: The main study in humans was done in 2660 women aged 18 to 65 years, and with symptoms of irritable bowel syndrome with constipation.
Danish: Hovedundersøgelsen på mennesker omfattede 2 660 kvinder, der var i alderen 18 til 65 år og havde symptomer på irritabel tyktarmssyndrom med forstoppelse.
English: The study compared Zelnorm 6 mg to placebo (a dummy treatment).
Danish: I undersøgelsen blev Zelnorm 6 mg sammenlignet med placebo (virkningsløs behandling).
English: What was Zelnorm expected to be used for?
Danish: Hvad forventedes Zelnorm anvendt til?
English: QUESTIONS AND ANSWERS ON RECOMMENDATION FOR REFUSAL OF MARKETING APPLICATION for ZELNORM
Danish: SPØRGSMÅL OG SVAR VEDRØRENDE ANBEFALINGEN AF AFSLAG PÅ ANSØGNINGEN OM MARKEDSFØRINGSTILLADELSE for ZELNORM
English: Which documentation has been presented by the Company to support the application to the CHMP?
Danish: Hvilken dokumentation har firmaet fremlagt i forbindelse med ansøgningen til CHMP?
English: It contains 6 mg of the active ingredient tegaserod.
Danish: Den indeholder 6 mg af det aktive stof, tegaserod.
English: It causes abnormal bowel function and makes the intestines more sensitive to normal stimulation, resulting in the above-mentioned symptoms.
Danish: Den medfører abnorm tarmfunktion og gør tarmene mere følsomme over for normal stimulation, hvilket forårsager de nævnte symptomer.
English: What are the consequences of the refusal for patients undergoing clinical trials with Zelnorm?
Danish: Hvilke konsekvenser har afslaget for patienter, der deltager i kliniske undersøgelser med Zelnorm?
English: The CHMP was of the opinion that Zelnorm's benefits are not greater than its risks.
Danish: CHMP var af den opfattelse, at fordelene ved Zelnorm ikke opvejer risiciene.
English: Tegaserod, the active ingredient in Zelnorm, is a receptor agonist.
Danish: Tegaserod, det aktive stof i Zelnorm, er en receptoragonist.
English: When these receptors are activated in the bowels, peristalsis that moves food along the bowels is stimulated.
Danish: Når disse receptorer bliver aktiveret i tarmene, stimulerer de tarmbevægelserne, der fører føden gennem tarmene.
English: These symptoms include pain or discomfort in the stomach or abdomen and a feeling of bloating.
Danish: Symptomerne er smerter eller ubehag i maven og en fornemmelse af oppustethed.
English: How is Zelnorm expected to work?
Danish: Hvordan forventes Zelnorm at virke?
English: Which were the major concerns, which lead to the refusal of the marketing authorisation by the CHMP?
Danish: Hvori bestod de vigtigste betænkeligheder, som førte til, at CHMP nægtede udstedelse af markedsføringstilladelse?
English: The CHMP was concerned that the results of the study would not translate into real benefit to the patient treated to relieve the symptoms of this disorder in standard health care setting.
Danish: CHMP fandt det betænkeligt, at undersøgelsens resultater ikke kunne tolkes som en reel fordel for de behandlede patienter i form af mildning af symptomerne i et normalt sundhedsplejemiljø.
English: Zelnorm is a tablet to be swallowed.
Danish: Zelnorm er en kapsel, der skal synkes.
English: EMEA/CHMP/109088/2006
Danish: EMEA/H/C/621
English: Zelnorm is approved outside the European Union for the treatment of irritable bowel syndrome and chronic constipation.
Danish: Zelnorm er uden for EU godkendt til behandling af IBSsyndrom (irritabel tyktarm) og kronisk forstoppelse.
English: The study looked at the effectiveness of Zelnorm to relieve the overall symptoms of the disease and discomfort or pain in the stomach or abdomen.
Danish: I undersøgelsen blev det registreret, hvor effektivt Zelnorm afhjalp de samlede symptomer på sygdommen eller ubehaget i maven.
English: Hence, the CHMP recommended that Zelnorm be refused marketing authorisation.
Danish: CHMP anbefalede derfor afslag på ansøgning om markedsføringstilladelse for Zelnorm.
English: Irritable bowel syndrome with constipation is a common disorder of the lower digestive system.
Danish: Irritabel tyktarmssyndrom med forstoppelse er en almindeligt forekommende funktionsforstyrrelse i den nedre del af mavetarmsystemet.
English: On 15 December 2005 the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Zelnorm 6 mg tablets.
Danish: Den 15. december 2005 vedtog Udvalget for Humanmedicinske Lægemidler (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgning om markedsføringstilladelse for lægemidlet Zelnorm, tabletter, 6 mg. På begæring af ansøgeren tog CHMP udtalelsen op til fornyet overvejelse og fastholdt sit tidligere standpunkt den 23. marts 2006.
English: Zelnorm was expected to be used to relieve the symptoms of irritable bowel syndrome with constipation in women.
Danish: Zelnorm forventedes anvendt til at mildne symptomerne på irritabel tyktarmssyndrom med forstoppelse hos kvinder.
English: Zelnorm aims to relieve the symptoms of irritable bowel syndrome with constipation in women.
Danish: Zelnorm er beregnet til at lette symptomerne på irritabel tyktarm med forstoppelse hos kvinder.
English: EMEA/CHMP/109088/2006 0.8, CURRENT ©EMEA 2006
Danish: ©EMEA 2007
English: No consequences for patients undergoing clinical trials have been identified by the CHMP.
Danish: CHMP finder ikke, at afslaget får konsekvenser for patienter, der deltager i kliniske undersøgelser.
English: • You are elderly.
Danish: • Du er ældre.
English: throughout the day.
Danish: hele dagen.
English: This could be dangerous to yourself and others.
Danish: Det kan være farligt for dig selv og andre.
English: Open here
Danish: Åben her
English: • You have had diabetes for a long time.
Danish: • Du har haft diabetes i lang tid.
English: You may need to talk about:
Danish: Du kan måske have behov for at tale om:
English: Need help?
Danish: Har du brug for hjælp?
English: • You drink alcohol - especially when you have not eaten much.
Danish: • Du drikker alkohol - især hvis du ikke spiser ret meget.
English: • How much Suliqua you need each day and at what time.
Danish: • Hvor meget Suliqua, du skal have hver dag og på hvilket tidspunkt af dagen.
English: Be especially aware of the following:
Danish: Vær især opmærksom på følgende:
English: Events per patient-year, n
Danish: Hændelser pr. patientår, n
English: ATC Code: A10AE54.
Danish: ATC-kode: A10AE54.
English: Frequency Very common Common
Danish: Hyppighed Meget almindelig Almindelig
English: • The possible effects of changing to different time zones.
Danish: • Mulige påvirkninger ved at skifte til andre tidszoner.
English: This must always be treated by a doctor, normally in a hospital.
Danish: Det skal altid behandles af en læge og foregår normalt på hospitalet.
English: • When you may need a higher or lower dose.
Danish: • Hvornår du eventuelt skal have en højere eller lavere dosis.
English: Talk to your doctor before travelling.
Danish: Tal med din læge, før du rejser.
English: The first signs may be in your body generally.
Danish: De første tegn optræder i kroppen generelt.
English: The information given below is based on studies with the monocomponents.
Danish: Nedenstående oplysninger er baseret på studier med monokomponenterne.
English: Most minor reactions to insulins usually disappear in a few days to a few weeks.
Danish: De fleste lette reaktioner på insulin forsvinder som regel i løbet af et par dage til et par uger.
English: Your concentration may be affected.
Danish: Din koncentrationsevne kan blive påvirket.
English: This may damage it.
Danish: Det kan beskadige den.
English: A. Choose a place to inject as shown in the picture above.
Danish: A. Vælg et injektionssted som vist på ovenstående billede.
English: Age, Race, Gender and Body weight
Danish: Alder, race, køn og kropsvægt
English: Turn your pen several times with your other hand to remove the needle.
Danish: Drej pennen flere gange med den anden hånd for at fjerne nålen.
English: • Any health risks in the countries you will visit.
Danish: • Sundhedsrisici i de lande, som du skal besøge.
English: Do not try to repair the pen.
Danish: Du må ikke forsøge at reparere pennen.
English: • You have recently had too low blood sugar (for example the day before).
Danish: • Du for nyligt har haft for lavt blodsukker (f.eks. dagen før).
English: Take a new pen out of the refrigerator at least 1 hour before you inject.
Danish: Tag en ny pen ud af køleskabet mindst 1 time før, du skal injicere.
English: Lixisenatide has a low level (55%) of binding to human proteins.
Danish: Lixisenatid har en lav bindingsgrad (55 %) til humane proteiner.
English: The median duration of study follow-up was 6.2 years.
Danish: Den mediane opfølgningsperiode var 6,2 år.
English: • You are doing less exercise than usual.
Danish: • Du dyrker mindre motion, end du plejer.
English: You also need to be careful when you stop taking a medicine.
Danish: Vær også forsigtig, når du holder op med at tage et lægemiddel.
English: • if there are particles in the Suliqua.
Danish: • hvis der er partikler i Suliqua.
English: This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or using machines).
Danish: Dette kan udgøre en risiko i situationer, hvor disse færdigheder er af særlig betydning (f.eks. ved bilkørsel eller betjening af maskiner).
English: • Your pen does not work properly.
Danish: • Din pen ikke virker rigtigt.
English: Extra items you will need:
Danish: Ting, som du har brug for:
English: Do not leave the pen in a car on an exceptionally warm or cold day.
Danish: Du må ikke lade pennen ligge i en bil på særligt varme eller kolde dage.
English: If the pen is damaged, has not been stored correctly, if you are not sure that it is working properly or you notice that your blood sugar control is unexpectedly getting worse:
Danish: Hvis pennen er beskadiget, ikke har været opbevaret korrekt, hvis du ikke er sikker på, at den virker korrekt, eller hvis du bemærker, at dit blodsukker uventet kontrolleres dårligere:
English: It is important to avoid dehydration by drinking plenty of fluids, especially during the first weeks of treatment with Suliqua.
Danish: Det er vigtigt at undgå dehydrering ved at drikke rigeligt med væske, især i de første ugers behandling med Suliqua.
English: STEP 1: Check your pen
Danish: TRIN 1: Kontrol af din pen
English: Close glucose monitoring is recommended during the transfer and in the following weeks.
Danish: Tæt glucosemonitorering anbefales under skiftet og i de efterfølgende uger.
English: • Never share your pen - it is only for you
Danish: • Du må aldrig låne din pen ud - den er kun til dig
English: If you find it difficult to recognise your warning signs, you should avoid situations (such as driving a car) in which you or others would be put at risk by hypoglycaemia.
Danish: Hvis du synes, det er svært at genkende dine advarselstegn, skal du undgå situationer (såsom bilkørsel), hvor du selv eller andre kan bringes i fare på grund af hypoglykæmi.
English: In such cases, you may develop severe hypoglycaemia (and even pass out) before you know what is happening.
Danish: I sådanne tilfælde kan du udvikle alvorlig hypoglykæmi (og endda besvime), før du selv bliver klar over, hvad der sker.