FrancophonIA/ELRC3.0 huggingface dataset:
English: In a post-hoc subgroup of patients with symptomatic angina at randomisation (n = 1,507), no safety signal was identified regarding cardiovascular death, hospitalisation for acute MI or heart failure (ivabradine 12.0% versus placebo 15.5%, p = 0.05).
Danish: I en post-hoc undergruppe, der omfattede patienter med symptomatisk angina pectoris ved randomiseringen (n=1.507), sås ingen faresignaler for så vidt angår kardiovaskulær død, indlæggelse pga.
English: Pink colour, round, beveled edge, biconvex film-coated tablets, approximately 6.65 mm in diameter debossed with “Ι 7” on one side and “M” on other side of the tablet.
Danish: Ivabradine JensonR 7,5 mg filmovertrukne tabletter Pink-farvede, runde med afskåret kant, bikonvekse filmovertrukne tabletter, der er ca. 6,65 mm i diameter og præget med “Ι 7” på den ene side og “M” på den anden side af tabletten.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG
English: itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin or erythromycin given orally), medicines to treat HIV infections (such as nelfinavir, ritonavir) or nefazodone (medicine to treat depression) or diltiazem, verapamil (used for high blood pressure or angina pectoris); - if you are a woman able to have children and not using reliable contraception; - if you are pregnant or trying to become pregnant; - if you are breast-feeding.
Danish: - malariamidler (fx mefloquin eller halofantrin) - intravenøs erythromycin (et antibiotikum) - pentamidin (et lægemiddel mod parasitter) - cisaprid (mod mavesyre-reflux fra mavesæk til spiserør) - nogle typer vanddrivende medicin (diuretika), der kan medføre nedsat kaliumniveau i blodet, såsom furosemid, hydrochlorthiazid, indapamid (anvendt til at behandle ødemer og højt blodtryk)
English: If you think that the effect of Ivabradine JensonR is too strong or too weak, talk to your doctor or pharmacist.
Danish: Tal med Deres læge eller apoteket, hvis De mener, at virkningerne af Ivabradine JensonR er for kraftige eller for svage.
English: NAME OF THE MEDICINAL PRODUCT Ivabradine JensonR 7.5 mg film-coated tablets ivabradine
Danish: LÆGEMIDLETS NAVN Ivabradine JensonR 7,5 mg filmovertrukne tabletter ivabradin
English: Hepatic impairment
Danish: Filmovertræk Hypromellose
English: Drug-drug interaction studies have established that CYP3A4 inhibitors increase ivabradine plasma concentrations, while inducers decrease them.
Danish: Hæmmere og induktorer af CYP3A4 er tilbøjelige til at interagere med ivabradin og påvirke dets metabolisme og farmakokinetik i klinisk signifikant grad. Lægemiddelinteraktionsstudier har vist, at CYP3A4-hæmmere øger plasmakoncen- trationen af ivabradin, mens induktorer nedsætter den.
English: A therapeutic scheme higher than the approved posology was used (starting dose 7.5 mg b.i.d.
Danish: Der blev anvendt et terapeutisk skema med højere doser end de godkendte (startdosis 7,5 mg to gange dagligt (5 mg to gange dagligt, hvis alderen er ≥ 75 år) og titreret op til 10 mg to gange dagligt).
English: mefloquine, halofantrine, pentamidine, cisapride, intravenous erythromycin).
Danish: - quinidin, disopyramid, ibutilid, sotalol, amiodaron (til behandling af forstyrrelser af
English: Angioedema Rash
Danish: Mylan dura GmbH
English: Muscle cramps
Danish: Arcana Arzneimittel GmbH
English: AV 1st degree block (ECG prolonged PQ interval) Ventricular extrasystoles Atrial fibrillation Palpitations, supraventricular extrasystoles
Danish: Palpitationer, supraventrikulære ekstrasystoler
English: Headache, generally during the first month of treatment Dizziness, possibly related to bradycardia
Danish: Hovedpine, specielt i den første behandlingsmåned
English: It is used in combination with standard therapy, including beta-blocker therapy or when beta-blockers are contraindicated or not tolerated.
Danish: Ivabradine JensonR bruges sammen med standardbehandling med betablokker, eller når patienten ikke må
English: Package leaflet: Information for the patient
Danish: Hjælpestof, som behandleren skal være opmærksom på:
English: Suspension (inactivated)
Danish: Solvens (inaktiveret)
English: --1 Lyophilisate (live attenuated) Canine distemper virus, strain CDV Bio 11/A
Danish: --1 Lyofilisat (levende svækket) Hundesygevirus, stamme CDV Bio 11/A
English: Package size Withdrawal period
Danish: Tilbageholdelsestid
English: Leptospira interrogans serogroup Australis serovar Bratislava, strain MSLB
Danish: Leptospira interrogans serogruppe Australis serovar Bratislava, stamme MSLB 1088
English: Leptospira interrogans serogroup Canicola serovar Canicola, strain MSLB
Danish: Leptospira interrogans serogruppe Canicola serovar Canicola, stamme MSLB 1090
English: This summary was last updated in 11-2010.
Danish: Dette sammendrag blev sidst ajourført i 11-2010.
English: These levels were maintained in over 93% of the children after two years.
Danish: Disse niveauer var fastholdt hos mere end 93 % af børnene efter to år.
English: Ambirix is a vaccine.
Danish: Ambirix er en vaccine.
English: The full EPAR for Ambirix can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Ambirix findes på agenturets websted på ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The vaccine should never be injected into a vein.
Danish: Vaccinen må aldrig injiceres i en blodåre.
English: The vaccine is ‘adsorbed'.
Danish: Vaccinen er ”adsorberet”.
English: This is a summary of the European public assessment report (EPAR) for Ambirix.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ambirix.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Danish: Vacciner fungerer ved at ”lære” kroppens naturlige forsvar (immunsystemet), hvordan det forsvarer sig mod en sygdom.
English: The European Commission granted a marketing authorisation valid throughout the EU for Ambirix to GlaxoSmithKline Biologicals s.a. on 30 August 2002.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ambirix til GlaxoSmithKline Biologicals s.a. den 30. august 2002.
English: Other information about Ambirix
Danish: Andre oplysninger om Ambirix
English: The CHMP decided that Ambirix's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Ambirix er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ambirix.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Ambirix.
English: For more information about treatment with Ambirix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ambirix, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: This means that the viruses and surface antigens are fixed onto aluminium compounds, to stimulate a better response.
Danish: Det vil sige, at vira og overfladeantigener er bundet til aluminiumsforbindelser for at fremkalde en bedre reaktion.
English: Three main studies of Ambirix were carried out in a total of 615 children from one year of age.
Danish: Der blev gennemført tre hovedundersøgelser af Ambirix hos i alt 615 børn fra 1 år og opefter.
English: The most common side effects with Ambirix (seen in more than one in 10 doses of the vaccine) are loss of appetite, irritability, headache, fatigue (tiredness) and pain and redness at the site of injection.
Danish: De mest almindelige bivirkninger ved Ambirix (set ved flere end 1 ud af 10 doser vaccine) er appetitløshed, irritabilitet, hovedpine, træthed samt smerter og rødme omkring injektionsstedet.
English: However, full protection against hepatitis B did not develop until the second dose of Ambirix had been given.
Danish: Der blev dog ikke opnået fuld beskyttelse mod hepatitis B, før den anden dosis Ambirix var givet.
English: Individuals who receive the first injection should complete the course with Ambirix.
Danish: De personer, der får den første injektion, bør gennemføre hele Ambirix-programmet.
English: Because Ambirix and Twinrix Adult contain identical ingredients, some of the data used to support the use of Twinrix Adult were used to support the use of Ambirix.
Danish: Da Ambirix og Twinrix Voksen har de samme indholdsstoffer, er nogle af de oplysninger, der blev brugt til at understøtte anvendelsen af Twinrix Voksen, også anvendt til at understøtte anvendelsen af Ambirix.
English: The three vaccines are used to protect against the same diseases, but Twinrix Adult and Twinrix Paediatric are given as a three-dose schedule.
Danish: De tre vacciner anvendes til at beskytte mod de samme sygdomme, men Twinrix Voksen og Twinrix Pædiatrisk gives som et tredosisprogram.
English: Ambirix was as effective as other vaccines against hepatitis A and B once the full vaccination course had been completed.
Danish: Ambirix var lige så effektiv som andre vacciner mod hepatitis A og B, når først hele vaccinationsprogrammet var blevet gennemført.
English: Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Danish: Hepatitis A (inaktiveret) og hepatitis B (rDNA) (HAB)-vaccine (adsorberet)
English: All of the children received two doses of Ambirix six months apart.
Danish: Alle børnene fik to doser Ambirix med seks måneders mellemrum.
English: An additional study in 208 children compared the vaccine's effectiveness when a six-month or a 12-month interval was used between the two injections.
Danish: I en yderligere undersøgelse med 208 børn sammenlignede man vaccinens virkning, når de to injektioner blev givet med henholdsvis 6 og 12 måneders mellemrum.
English: The active substances in Ambirix have been available in other vaccines authorised in the European Union (EU): Ambirix contains the same ingredients as Twinrix Adult, which has been authorised since 1996, and as Twinrix Paediatric, which has been authorised since 1997.
Danish: De aktive stoffer i Ambirix har været anvendt i andre vacciner, der er godkendt i EU, og Ambirix har de samme indholdsstoffer som Twinrix Voksen, der har været godkendt siden 1996, og som Twinrix Pædiatrisk, der har været godkendt siden 1997.
English: Because of this, Ambirix should only be used when there is a low risk of hepatitis B infection during the vaccination course, and when it is certain that the two-dose vaccination course can be completed.
Danish: Ambirix bør derfor kun anvendes, når risikoen for infektion med hepatitis B er lav i løbet af vaccinationsprogrammet, og kun når det er sikkert, at todosis-vaccinationsprogrammet kan gennemføres.
English: Ambirix should not be used in people who may be hypersensitive (allergic) to any of the active substances, to any of the other ingredients or to neomycin (an antibiotic).
Danish: Ambirix bør ikke anvendes af personer, der kan være overfølsomme over for et af de aktive stoffer, et af de andre indholdsstoffer eller antibiotikummet neomycin.
English: Ambirix is given as two injections six to 12 months apart into the muscle of the upper arm, or into the thigh in very young children.
Danish: Ambirix gives som to injektioner med 6-12 måneders mellemrum i overarmsmusklen (eller i låret hos meget små børn).
English: Ambirix is used as a two-dose schedule and protection against hepatitis B may not be obtained until after the second dose.
Danish: Ambirix gives som et todosisprogram, og beskyttelsen mod hepatitis B opnås muligvis først efter den anden dosis.
English: Two of the studies compared Ambirix with other vaccines against hepatitis A and B. The main measure of effectiveness was the proportion of vaccinated children who developed protective levels of antibodies one month after the last injection.
Danish: I to af undersøgelserne blev Ambirix sammenlignet med andre vacciner mod hepatitis A og B. Det primære mål for virkningen var andelen af vaccinerede børn, som havde udviklet en beskyttende antistofmængde en måned efter den sidste injektion.
English: For the full list of all side effects reported with Ambirix, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Ambirix fremgår af indlægssedlen.
English: What is the risk associated with Ambirix?
Danish: Hvilken risiko er der forbundet med Ambirix?
English: Ambirix is a vaccine that contains inactivated (killed) hepatitis A virus and parts of the hepatitis B virus as active substances.
Danish: Ambirix er en vaccine, der indeholder inaktiveret (dræbt) hepatitis A-virus og dele af hepatitis B-virus som aktive stoffer.
English: The additional study showed that the levels of protection with Ambirix were similar with a six- and a 12-month gap between injections.
Danish: Den yderligere undersøgelse viste, at beskyttelsesniveauet med Ambirix var omtrent det samme, når der gik henholdsvis 6 og 12 måneder mellem injektionerne.
English: When a child is given the vaccine, the immune system recognises the viruses and surface antigens as ‘foreign' and makes antibodies against them., The immune system will then be able to make antibodies more quickly when exposed to the viruses again.
Danish: Når et barn bliver vaccineret, opfatter immunsystemet vira og overfladeantigener som fremmede og danner antistoffer mod dem.
English: Ambirix contains small amounts of inactivated hepatitis A viruses and the ‘surface antigen' (proteins from the surface) of the hepatitis B virus.
Danish: Ambirix indeholder små mængder inaktiveret hepatitis Avirus og proteiner fra overfladen af hepatitis B-virus, såkaldte overfladeantigener.
English: Ambirix led to the development of protective levels of antibodies against hepatitis A and B in between 98 and 100% of the vaccinated children one month after the last injection.
Danish: Ambirix bevirkede, at mellem 98 og 100 % af de vaccinerede børn udviklede beskyttende niveauer af antistoffer mod hepatitis A og B en måned efter den sidste injektion.
English: Why has Ambirix been approved?
Danish: Hvorfor blev Ambirix godkendt?
English: What benefit has Ambirix shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Ambirix?
English: How has Ambirix been studied?
Danish: Hvordan blev Ambirix undersøgt?
English: Where a booster dose of hepatitis A or B is desired, Ambirix, or a separate hepatitis A or B vaccine may be given.
Danish: Der kan gives Ambirix eller en særskilt hepatitis A- eller B-vaccine i de tilfælde, hvor man ønsker at give en boosterdosis (forstærkningsdosis) af hepatitis A- eller B-vaccine.
English: The antibodies will help to protect against the diseases caused by these viruses.
Danish: Når immunsystemet efterfølgende udsættes for sådanne vira, vil det være i stand til hurtigere at producere antistoffer mod dem. Antistofferne hjælper med at beskytte mod de sygdomme, der fremkaldes af disse vira.
English: What is Ambirix used for?
Danish: Hvad anvendes Ambirix til?
English: How is Ambirix used?
Danish: Hvordan anvendes Ambirix?
English: What is Ambirix?
Danish: Hvad er Ambirix?
English: Ambirix is used to protect against hepatitis A and hepatitis B (diseases that affect the liver) in children between one and 15 years of age who are not already immune to these two diseases.
Danish: Den bruges til børn mellem 1 og 15 år, der ikke allerede er immune over for disse to sygdomme.
English: Vaccination with Ambirix should be postponed in patients with a severe sudden fever.
Danish: der har haft en overfølsomhedsreaktion efter at være blevet vaccineret mod hepatitis A eller hepatitis B. Vaccination med Ambirix skal udskydes hos patienter med pludseligt opstået, alvorlig feber.
English: How does Ambirix work?
Danish: Hvordan virker Ambirix?
English: 1 In the context of a referral procedure under Article 31 of Directive 2001/83/EC.
Danish: 1 Ved en indbringelsesprocedure i henhold til artikel 31 i direktiv 2001/83/EF.
English: The average dose used was 600 to 800 mg per day.
Danish: Den gennemsnitlige dosis var 600-800 mg dagligt.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ketoconazole HRA on 19 November 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ketoconazole HRA den 19. november 2014.
English: In addition the CHMP considered that additional treatment options are needed for this rare disease.
Danish: Desuden fandt CHMP, at der er behov for yderligere behandlingsmuligheder for denne sjældne sygdom.
English: The most serious side effects are liver problems which can be detected early through regular monitoring.
Danish: De alvorligste bivirkninger er leverproblemer, der ved regelmæssig overvågning lader sig påvise tidligt.
English: The patient's liver function should be checked with blood tests before treatment is started and regularly for the following 6 months.
Danish: Patientens leverfunktion bør kontrolleres ved blodprøver før påbegyndelse af behandlingen og derefter regelmæssigt i de efterfølgende seks måneder.
English: However, oral formulations (used by mouth) for the treatment of fungal infections were suspended in July 2013 because of the risk of liver injury.1
Danish: Formuleringer til indtagelse gennem munden (orale formuleringer) til behandling af svampeinfektioner blev dog midlertidigt taget af markedet i juli 2013 pga. risikoen for leverskade1
English: Ketoconazole treatment was shown to normalise urine cortisol levels in 43 to 80% of patients.
Danish: Behandling med ketoconazol blev påvist at normalisere kortisolindholdet i urinen hos 43-80 % af patienterne.
English: Regarding its safety the CHMP considered that the risk of liver problems can be managed through appropriate measures.
Danish: Vedrørende sikkerheden fandt CHMP, at risikoen for leverproblemer kan håndteres ved passende foranstaltninger.
English: It must also not be used in pregnant or breastfeeding women or patients who have QTc prolongation (disruption of the electrical activity of the heart).
Danish: Det må heller ikke bruges hos gravide eller ammende kvinder eller hos patienter med forstyrrelse i hjertets elektriske aktivitet (QTc-forlængelse).
English: The usual treatment dose is between 400 mg and 1,200 mg per day taken in two or three divided doses.
Danish: Den sædvanlige dosis er 400-1 200 mg dagligt, fordelt på to eller tre doser.
English: The dose is adjusted according to the levels of cortisol in the body, which is measured by regular checks of the urine or blood.
Danish: Dosis tilpasses efter kroppens indhold af kortisol, som måles ved regelmæssig kontrol af urinen eller blodet.
English: This is a summary of the European public assessment report (EPAR) for Ketoconazole HRA.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ketoconazole HRA.
English: Because the number of patients with Cushing's syndrome is low, the disease is considered ‘rare', and Ketoconazole HRA was designated an ‘orphan medicine' (a medicine used in rare diseases) on 23 April 2012.
Danish: Da antallet af patienter med Cushings sygdom er lavt, betragtes sygdommen som “sjælden”, og Ketoconazole HRA blev udpeget som “lægemiddel til sjældne sygdomme” den 23. april 2012.
English: Blocking cortisol production will help to reduce cortisol levels in the body, thereby relieving the symptoms of the disease.
Danish: Blokering af kortisolproduktionen nedsætter kortisolindholdet i kroppen og letter derfor symptomerne på sygdommen.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Ketoconazole HRA'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) afgjorde, at fordelene ved Ketoconazole HRA overstiger risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Ketoconazole blocks the activity of a group of enzymes in the adrenal glands involved in the production of cortisol, such as 17 alpha-hydroxylase or 11β-hydroxylase.
Danish: Ketoconazol blokerer aktiviteten af en gruppe enzymer i binyrerne, der medvirker ved produktionen af kortisol, såsom 17α-hydroxylase eller 11β-hydroxylase.
English: A risk management plan has been developed to ensure that Ketoconazole HRA is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Ketoconazole HRA anvendes så sikkert som muligt.
English: Ketoconazole HRA is available as tablets (200 mg).
Danish: Ketoconazole HRA leveres som tabletter (200 mg).
English: Because ketoconazole is a well-known substance, and its use in Cushing's syndrome is well established, the applicant presented data from the published literature on more than 800 patients with Cushing's syndrome who were treated with ketoconazole either alone or in combination with other treatments.
Danish: Da ketoconazol er et velkendt stof og er anerkendt til behandling af Cushings syndrom, fremlagde ansøgeren data fra den publicerede litteratur om mere end 800 patienter med Cushings syndrom, der var behandlet med ketoconazol enten alene eller i kombination med andre lægemidler.
English: It can only be obtained with a prescription and treatment must be started and supervised by a doctor experienced in treating patients with Cushing syndrome who has access to appropriate facilities to assess the patient's response.
Danish: Lægemidlet fås kun på recept, og behandlingen skal påbegyndes og ske under opsyn af en læge, som har erfaring i behandling af patienter med Cushings syndrom og råder over egnede faciliteter til at vurdere behandlingens virkning.
English: Ketoconazole HRA is a medicine used to treat adults and children above the age of 12 years with Cushing's syndrome.
Danish: Ketoconazole HRA er et lægemiddel, der anvendes til at behandle voksne og børn over 12 år med Cushings syndrom.
English: The full EPAR and risk management plan summary for Ketoconazole HRA 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 Ketoconazole HRA findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The most common side effects with Ketoconazole HRA are adrenal insufficiency (too low a level of the hormones produced by the adrenal gland), nausea (feeling sick), vomiting, abdominal pain (stomach ache), diarrhoea, pruritus (itching), rash and increase in blood levels of liver enzymes.
Danish: De hyppigste bivirkninger med Ketoconazole HRA er for lavt indhold af de hormoner, der produceres af binyrerne (binyreinsufficiens), kvalme, opkastning, mavesmerter, diarré, kløe (pruritus), udslæt og stigning i blodets indhold af leverenzymer.
English: The company will also set up a registry of patients treated with Ketoconazole HRA in order to monitor the safety and effectiveness of the medicine.
Danish: Virksomheden skal desuden oprette et register over patienter behandlet med Ketoconazole HRA for at overvåge lægemidlets sikkerhed og virkning.
English: Ketoconazole HRA must also not be used together with certain medicines that may increase the risk of serious side effects.
Danish: Ketoconazole HRA må ikke anvendes sammen med visse andre lægemidler, der kan øge risikoen for alvorlige bivirkninger.