FrancophonIA/ELRC3.0 huggingface dataset:
English: 10 pre-filled syringes + 10 needles 10 x 1 dose (1 ml)
Danish: 10 fyldte injektionssprøjter +10 kanyler 10 x 1 dosis (1ml)
English: Hepatitis A virus (inactivated)1,2
Danish: Hepatitis A-virus (inaktiveret)
English: Nervous system disorders Uncommon: dizziness Rare: paraesthesia
Danish: Nervesystemet Ikke almindelig: svimmelhed Sjælden: paræstesi
English: Nervous system disorders Very common: headache Common: drowsiness
Danish: Nervesystemet Meget almindelig: hovedpine Almindelig: døsighed
English: Skin and subcutaneous tissue disorders Rare: pruritus, rash
Danish: Hud og subkutane væv Sjælden: pruritus, udslæt Meget sjælden: urticaria
English: How to store Ambirix
Danish: Sådan gives Ambirix
English: 10 x 1 dose (1 ml)
Danish: 10 x 1 dosis (1ml)
English: They may be very tired, and have dark urine, pale faeces, yellowish skin or eyes (jaundice).
Danish: Nogle kan føle voldsom træthed, have mørkfarvet urin, lys afføring og gullig hudfarve eller øjne (gulsot).
English: Musculoskeletal and connective tissue disorders Arthritis, muscular weakness
Danish: Knogler, led, muskler og bindevæv Artritis, muslelsvaghed
English: • Clinical trial data
Danish: • Data fra kliniske studier
English: The virus is found in body fluids such as faeces, serum or saliva.
Danish: Virus findes i kropsvæsker såsom afføring, blod og spyt.
English: Immune system disorders Allergic reactions including mimicking serum sickness, angioneurotic oedema
Danish: Immunsystemet Allergiske reaktioner omfattende serumsyge-lignende sygdom, angioødem
English: It is not known exactly how long protection against infection with hepatitis A and B viruses will last, although protection against the hepatitis A virus probably lasts about 10 years.
Danish: Beskyttelsen mod hepatitis A-virus vil formodentlig vare ca. 10 år.
English: For adjuvants, see section 2.
Danish: Alle hjælpestoffer er anført under se pkt.
English: Very common (These may occur with more than 1 in 10 doses of the vaccine) :
Danish: Meget almindelig (kan forekomme ved flere end 1 ud af 10 vaccinedoser):
English: Anti-HBs Month 2 SP (%)
Danish: Anti-HBs Måned 2 SP (%)
English: Additional side effects that have been reported during clinical trials with very similar combined hepatitis A and hepatitis B vaccines, include:
Danish: Yderligere er følgende bivirkninger set i kliniske studier med lignende kombinerede hepatitis Aog hepatitis B-vacciner:
English: Anti-HBs Month 7 SP (%)
Danish: Anti-HBs Måned 7 SP (%)
English: Additional side effects that occurred during routine use of very similar combined or individual hepatitis A and hepatitis B vaccines were as follows:
Danish: Følgende bivirkninger er yderligere set ved rutinemæssig brug af lignende vacciner mod hepatitis A og hepatitis B-infektion enkeltvist eller i kombination:
English: Anti-HBs Month 6 SP (%)
Danish: Anti-HBs Måned 6 SP (%)
English: 1-5 yrs old
Danish: 1-5 år
English: Package Leaflet: Information for the user Ambirix suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Danish: Indlægsseddel: Information til brugeren Ambirix, injektionsvæske, suspension i fyldt injektionssprøjte Hepatitis A (inaktiveret)- og hepatitis B (rDNA) (HAB)-vaccine (adsorberet)
English: General disorders and administration site conditions Immediate injection site pain, stinging and burning sensation
Danish: Almene symptomer og reaktioner på administrationsstedet Smerte på injektionsstedet umiddelbart efter injektionen, sviende og brændende fornemmelse.
English: • swelling where the injection was given
Danish: • hævelse hvor injektionen blev givet
English: The following adverse reactions were reported during post-marketing surveillance following vaccination with Ambirix.
Danish: Efter markedsføring er følgende bivirkninger rapporteret efter vaccination med Ambirix:
English: Rare (These may occur with up to 1 in 1,000 doses of the vaccine) :
Danish: Sjælden (kan forekomme ved op til 1 ud af 1.000 vaccinedoser):
English: • abnormal test results relating to the liver
Danish: • unormale leverprøver
English: • flu-like symptoms, such as high temperature, sore throat, runny nose, cough and chills
Danish: • hævede lymfekirtler i hals, armhuler eller lyske • influenza-lignende symptomer f.eks. høj feber, ondt i halsen, løbenæse, hoste og kulderystelser
English: NAME OF THE MEDICINAL PRODUCT Ambirix - Suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Danish: Ambirix - injektionsvæske, suspension i fyldt injektionssprøjte Hepatitis A- (inaktiveret) og hepatitis B (rDNA) (HAB)-vaccine (adsorberet)
English: 3Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4Adsorbed on aluminium phosphate
Danish: Produceret på gærceller (Saccharomyces cerevisiae) ved rekombinant DNA teknologi Adsorberet til aluminumphosphat
English: Side effects that occurred during clinical trials with Ambirix were as follows:
Danish: Følgende bivirkninger er set i kliniske studier med Ambirix:
English: GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 dk-info@gsk.com
Danish: GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00
English: The need for a booster dose of hepatitis B vaccine in healthy individuals who have received a full primary vaccination course has not been established.
Danish: Behovet for en boosterdosis med hepatitis B-vaccine hos raske personer, som har fået et fuldt primært vaccinationsprogram, er ikke blevet fastlagt; dog indeholder nogle officielle vaccinationsprogrammer en anbefaling for booster-dosis af hepatitis B-vaccine, hvilket skal respekteres.
English: Protection against hepatitis B infections may not be obtained until after the second dose (see section Therefore: - Ambirix should be used only when there is a relatively low risk of hepatitis B infection during the vaccination course.
Danish: Beskyttelse mod hepatitis B-infektioner vil først opnås efter 2. dosis (se pkt.
English: United Kingdom GlaxoSmithKline UK Tel: +44 (0)800 221 441 customercontactuk@gsk.com
Danish: United Kingdom GlaxoSmithKline UK Tel: +44 (0)800 221 441
English: - Hepatitis B surface antigen 3,4
Danish: - Hepatitis B-overfladeantigen
English: Musculoskeletal and connective tissue disorders Uncommon: myalgia
Danish: Knogler, led, muskler og bindevæv Ikke almindelig: myalgi Sjælden: artralgi
English: • fits or seizures
Danish: • mave- og fordøjelsesgener
English: NAME OF THE MEDICINAL PRODUCT Ambirix suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed).
Danish: Ambirix, injektionsvæske, suspension i fyldt injektionssprøjte Hepatitis A (inaktiveret)- og hepatitis B (rDNA) (HAB)-vaccine (adsorberet).
English: Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopenia or bleeding disorders.
Danish: Hos patienter med thrombocytopeni eller blødningsforstyrrelse kan vaccinen undtagelsesvis administreres subkutant.
English: GlaxoSmithKline Latvia SIA Tel: + 371 67312687 lv-epasts@gsk.com
Danish: GlaxoSmithKline Latvia SIA Tel: + 371 67312687
English: Uncommon (These may occur with up to 1 in 100 doses of the vaccine) :
Danish: Ikke almindelig (kan forekomme ved op til 1 ud af 100 vaccinedoser):
English: Hepatobiliary disorders Abnormal liver function tests
Danish: Lever og galdeveje Unormale leverfunktionsprøver
English: The percentages with anti-HBs antibody ≥10 mIU/ml at this time point for subjects vaccinated at the 0, 6 and 0, 12
Danish: Procentdelen af børn med anti-HBs-antistof ≥ 10 mIE/ml var på dette tidspunkt 84,8 % og 92,9 % for hhv. børn vaccineret efter 0, 6 måneders-vaccinationsprogrammet og efter 0, 12 måneders-vaccinationsprogrammet.
English: Common (These may occur with up to 1 in 10 doses of the vaccine) :
Danish: Almindelig (kan forekomme ved op til 1 ud af 10 vaccinedoser):
English: • If you have any further questions, ask your doctor, nurse or pharmacist.
Danish: Er du i tvivl, så spørg lægen, sundhedspersonalet eller apotekspersonalet.
English: At 10 years following the initiation of a 0, 6 month schedule of Ambirix in children aged 1-15 years,
Danish: 10 år efter indledningen af et 0, 6 måneders-vaccinationsprogram med Ambirix til børn i alderen 1-15 år havde alle børn stadig ≥ 15 mIE/ml anti-HAV-antistof.
English: • If you/your child gets any side effects, talk to your doctor, nurse or pharmacist.
Danish: • Kontakt lægen, sundhedspersonalet eller apotekspersonalet, hvis en bivirkning bliver værre, eller du eller dit barn får bivirkninger, som ikke er nævnt her.
English: • disease mainly affecting the joints with pain and swelling (arthritis), muscular weakness
Danish: • ledsmerter og hævede led på grund af betændelse, muskelsvaghed
English: HAB vaccine
Danish: Sådan gives vaccinationen
English: • swelling of the face, mouth and throat (angioneurotic oedema)
Danish: • hævelse af ansigt, mund og svælg
English: • numbness or weakness of the arms and legs (neuropathy)
Danish: • føleforstyrrelser eller svaghed i arme og ben pga. nervebetændelse
English: Tel: + 31 (0)30 69 38 100 nlinfo@gsk.com
Danish: GlaxoSmithKline BV Tel: + 31 (0)30 69 38 100 nlinfo@gsk.com
English: Ambirix should not be given if any of the above apply.
Danish: Hvis noget af ovennævnte er gældende, må du ikke få Ambirix.
English: • swelling or infection of the brain (encephalitis)
Danish: • hævelse eller infektion i hjernen
English: • reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia),
Danish: • øget risiko for blødning og blå mærker, samt blåviolette eller rødbrune mærker på huden på grund af forandringer i blodet (nedsat antal blodplader)
English: What Ambirix looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: • inflammation of the nerves (neuritis)
Danish: • nervebetændelse
English: Posology
Danish: Dosis
English: ≥ 1/1,000 to < 1/100
Danish: Ikke almindelig: ≥ 1/1.000 til < 1/100 Sjælden:
English: • inflammation of some blood vessels (vasculitis)
Danish: • betændelse i blodkar
English: Very common: appetite lost
Danish: Metabolisme og ernæring Meget almindelig: appetitløshed
English: What was Onzeald expected to be used for?
Danish: Hvad forventedes Onzeald anvendt til?
English: The company that applied for authorisation is Nektar Therapeutics UK Limited.
Danish: Den virksomhed, der søgte om tilladelse, var Nektar Therapeutics UK Limited.
English: The CHMP refusal was confirmed after re-examination.
Danish: CHMP's afslag blev bekræftet efter revurderingen.
English: What is Onzeald?
Danish: Hvad er Onzeald?
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse og har behov for mere information om din behandling, kan du kontakte din behandlende læge.
English: The company requested a re-examination of the initial opinion.
Danish: Virksomheden anmodede om en revurdering af udtalelsen.
English: The company informed the CHMP that patients receiving the medicine in clinical trials will continue to do so as planned.
Danish: Virksomheden har til CHMP oplyst, at de patienter, der får lægemidlet i kliniske undersøgelser, vil fortsætte med dette som planlagt.
English: In this study, Onzeald was compared with standard cancer medicines chosen by the treating doctor, and the main measure of effectiveness was overall survival (how long the patients lived).
Danish: I denne undersøgelse blev Onzeald sammenlignet med standardlægemidler mod kræft, der var valgt af den behandlende læge, og virkningen blev hovedsagelig målt på den samlede overlevelse (hvor længe patienterne levede).
English: On 20 July 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Onzeald, intended for the treatment of advanced breast cancer that has spread to the brain.
Danish: Den 20. juli 2017 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse, hvori det anbefalede afslag på ansøgningen om markedsføringstilladelse for lægemidlet Onzeald, der er beregnet til behandling af fremskreden brystkræft, der har bredt sig til hjernen.
English: Refusal of the marketing authorisation for Onzeald (etirinotecan pegol) EMA/736863/2017
Danish: Afslag på ansøgningen om markedsføringstilladelse for Onzeald (etirinotecan pegol) EMA/736863/2017
English: 10 November 2017 EMA/736863/2017 EMEA/H/C/003874
Danish: Den 10. november 2017 EMA/736863/2017
English: The Committee considered that the data from this subgroup, which were not supported by additional studies, were not sufficient to prove the effectiveness of Onzeald, even when analysed by different methods.
Danish: Udvalget fandt, at dataene fra denne undergruppe, som ikke var understøttet af supplerende undersøgelser, ikke var tilstrækkelige til at påvise virkningen af Onzeald, selv når de blev analyseret på forskellige måder.
English: By blocking the enzyme, cancer cells are prevented from multiplying and they eventually die.
Danish: Ved at blokere enzymet forhindres kræftcellerne i at formere sig og dør til sidst.
English: The company presented the results of one main study involving 852 patients with breast cancer that had spread to other parts of the body who had been treated with at least 2 other cancer medicines.
Danish: Virksomheden fremlagde resultaterne af en hovedundersøgelse med 852 patienter med brystkræft, der havde bredt sig til andre dele af kroppen, og som var blevet behandlet med mindst to andre kræftlægemidler.
English: Therefore, the CHMP was of the opinion that the study did not provide enough evidence on the benefits of Onzeald and recommended that the marketing authorisation be refused.
Danish: CHMP var derfor af den opfattelse, at undersøgelsen ikke i tilstrækkelig grad dokumenterede fordelene ved Onzeald, og anbefalede at give afslag på ansøgningen om markedsføringstilladelse.
English: Irinotecan has been authorised in the EU for a number of years for the treatment of colorectal cancer.
Danish: Irinotecan har i en årrække været godkendt i EU til behandling af kræft i tyktarmen og endetarmen.
English: Because it is pegylated in etirinotecan pegol, the medicine is removed from the body at a slower rate, allowing the medicine to be given less often.
Danish: Da det er pegyleret i etirinotecan pegol, udskilles lægemidlet langsommere, og det behøver derfor ikke gives så ofte.
English: Onzeald is a cancer medicine that contains the active substance etirinotecan pegol.
Danish: Onzeald er et kræftlægemiddel, der indeholder det aktive stof etirinotecan pegol.
English: Refusal of the marketing authorisation for Onzeald (etirinotecan pegol)
Danish: Afslag på ansøgningen om markedsføringstilladelse for Onzeald (etirinotecan pegol)
English: After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorisation on 9 November 2017.
Danish: CHMP gennemgik begrundelsen for anmodningen og revurderede udtalelsen, og bekræftede den 9. november 2017 afslaget på ansøgningen om markedsføringstilladelse.
English: The active substance in Onzeald, etirinotecan pegol, consists of irinotecan (a cancer medicine that belongs to the group ‘topoisomerase inhibitors') that has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Danish: Det aktive stof i Onzeald, etirinotecan pegol, består af irinotecan (et kræftlægemiddel, som tilhører gruppen "topoisomerasehæmmere"), der er blevet "pegyleret" (knyttet til et kemikalie kaldet polyethylenglycol).
English: The claim of effectiveness relied on data from a subgroup of patients from a main study which, overall, failed to convincingly show the effectiveness of Onzeald.
Danish: Den påståede virkning var understøttet af data fra en undergruppe af patienter i en hovedundersøgelse, som overordnet ikke påviste Onzealds virkning overbevisende.
English: How does Onzeald work?
Danish: Hvordan virker Onzeald?
English: Irinotecan blocks topoisomerase I, an enzyme that is involved in copying cell DNA, which is needed to make new cells.
Danish: Irinotecan blokerer enzymet topoisomerase I, som medvirker til at kopiere celleDNA, hvilket er nødvendigt for at danne nye celler.
English: It was to be available as a powder to be made into a solution for infusion (drip) into a vein.
Danish: Det var hensigten, at det skulle markedsføres som et pulver, der blandes til en opløsning til infusion (drop) i en vene.
English: The CHMP considered that the benefit of Onzeald in the treatment of advanced breast cancer that had spread to the brain and other parts of the body had not been sufficiently demonstrated.
Danish: CHMP vurderede, at fordelene ved Onzeald til behandling af fremskreden brystkræft, der har bredt sig til hjernen og andre dele af kroppen, ikke var tilstrækkeligt påvist.
English: Onzeald was expected to be used to treat adults with advanced breast cancer that had spread to the brain and other parts of the body and who have already received other treatments.
Danish: Onzeald forventedes anvendt til behandling af voksne med fremskreden brystkræft, der har bredt sig til hjernen og andre dele af kroppen, og som allerede har fået anden behandling.
English: The final opinion was converted into a Decision by the European Commission on 5 August 2011.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 5. august 2011.
English: The mutual recognition procedure (UK/V/0354/001/MR) started on 26 November 2009.
Danish: Den gensidige anerkendelsesprocedure (UK/V/0354/001/MR) indledtes den 26. November 2009.
English: On 2 July 2010, the United Kingdom, as Reference Member State, referred the matter to the European Medicines Agency under Article 33(4) of Directive 2001/82/EC, due to concerns raised by the Concerned Member State, Ireland, that the safety and efficacy of the product had not been sufficiently demonstrated.
Danish: Den 2. juli 2010 indbragte Det Forenede Kongerige som referencemedlemsstat sagen for Det Europæiske Lægemiddelagentur i henhold til artikel 33, stk. 4, i direktiv 2001/82/EF, eftersom den berørte medlemsstat, Irland, havde udtrykt bekymring for, at der ikke var fremlagt tilstrækkelig dokumentation for produktets sikkerhed og virkning.
English: negative, and therefore adopted an opinion on 6 April 2011 recommending the refusal of the granting of the marketing authorisation and suspension of the existing marketing authorisation.
Danish: negativ, og vedtog derfor den 6. april 2011 en udtalelse, der anbefaler afslag på ansøgningen om markedsføringstilladelse og suspendering af den eksisterende markedsføringstilladelse.
English: The marketing authorisation holder, Norbrook Laboratories Ltd, submitted an application for Combimox via a mutual recognition procedure in Ireland on the basis of the marketing authorisation granted by the United Kingdom.
Danish: Indehaveren af markedsføringstilladelsen, Norbrook Laboratories Ltd, indgav en ansøgning vedrørende Combimox via en gensidig anerkendelsesprocedure i Irland på grundlag af den markedsføringstilladelse, der er udstedt af Det Forenede Kongerige.
English: Based on the evaluation of the rapporteur's assessment of the currently available data, the CVMP considered that the benefit/risk profile of Combimox Lactating Cow Intramammary Suspension is
Danish: På grundlag af evalueringen af rapportørens vurdering af de aktuelt foreliggende data var CVMP af den opfattelse, at risk/benefit-forholdet for Combimox Lactating Cow Intramammary Suspension er
English: Combimox is intended for the treatment of mastitis in lactating cows.
Danish: Combimox er beregnet til behandling af mastitis hos diegivende kvæg.
English: Combimox Lactating Cow Intramammary Suspension (Combimox) is an intramammary suspension containing amoxicillin, clavulanic acid and prednisolone.
Danish: Combimox Lactating Cow Intramammary Suspension (Combimox) er en intramammær suspension, der indeholder amoxicillin, clavulansyre og prednisolon.
English: Both groups had off periods of about 36-37% at the start of the study.
Danish: Begge grupper havde off-perioder på 36-37 % ved undersøgelsens begyndelse.
English: Other information about Numient
Danish: Andre oplysninger om Numient
English: This is a summary of the European public assessment report (EPAR) for Numient.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Numient.
English: The full EPAR and risk management plan summary for Numient can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Numient findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: A risk management plan has been developed to ensure that Numient is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Numient anvendes så sikkert som muligt.
English: The patient should then swallow the food immediately without chewing.
Danish: Patienterne skal derefter straks synke maden uden at tygge den.
English: Numient capsules are taken with a glass of water.
Danish: Kapslerne med Numient skal tages med et glas vand.
English: They can be taken with or without food, but should not be taken at the same time as high protein meals, which can reduce absorption.
Danish: De kan tages sammen med et måltid eller mellem måltiderne, men bør ikke tages sammen med et proteinrigt måltid, da dette kan nedsætte absorptionen.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Numient's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Numient opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: These types of capsules are known as modifiedrelease capsules.
Danish: Denne type kapsler kaldes kapsler med modificeret udløsning.
English: Patients who took placebo had an average improvement of 0.6 points.
Danish: Hos de patienter, der fik placebo, var bedringen i gennemsnit 0,6 point.
English: What is Numient and what is it used for?
Danish: Hvad er Numient, og hvad anvendes det til?
English: The starting dose for patients who have not previously taken levodopa is one capsule containing 95 mg of levodopa and 23.75 mg of carbidopa, three times daily for the first three days.
Danish: Startdosis for patienter, der ikke før har fået levodopa, er én kapsel indeholdende 95 mg levodopa og 23,75 mg carbidopa tre gange dagligt i de første tre dage.
English: After 13 weeks, patients taking Numient had off periods of about 24% of their waking hours compared with 30% of waking hours in patients taking the comparator medicine.
Danish: Efter 13 uger havde de patienter, der fik Numient, off-perioder i omkring 24 % af deres vågne tid, sammenholdt med 30 % af den vågne tid hos de patienter, der fik sammenligningslægemidlet.
English: What measures are being taken to ensure the safe and effective use of Numient?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Numient?
English: Why is Numient approved?
Danish: Hvorfor er Numient blevet godkendt?
English: The most frequent side effects with Numient are nausea in (12% of patients), dizziness, headache and involuntary movements (each occurring in 8% of patients), and insomnia (in 6% of patients).
Danish: Den hyppigste bivirkning ved Numient er kvalme (hos 12 % af patienterne), svimmelhed, hovedpine og ufrivillige bevægelser (der hver optræder hos 8 % af patienterne) og søvnløshed (insomni) (hos 6 % af patienterne).
English: For patients already taking levodopa, the doctor will determine the dose of Numient based on their current treatment.
Danish: For patienter, der allerede får levodopa, ville lægen fastsætte en dosis af Numient på grundlag af den aktuelle behandling.