FrancophonIA/ELRC3.0 huggingface dataset:
English: On 21 March 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Labazenit, intended for the treatment of asthma.
Danish: Den 21. marts 2013 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgningen om markedsføringstilladelse for lægemidlet Labazenit til astmabehandling.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 27 June 2013.
Danish: Efter at have gennemgået begrundelsen for anmodningen foretog CHMP en fornyet overvejelse af den første udtalelse og fastholdt den 27. juni 2013 afslaget på ansøgningen om markedsføringstilladelse.
English: How is Labazenit expected to work?
Danish: Hvordan forventes Labazenit at virke?
English: The company presented results of two main studies that compared Labazenit with salmeterol alone in a total of 83 asthma patients, and one main study comparing Labazenit with budesonide alone in 375 patients.
Danish: Virksomheden forelagde resultaterne af to hovedundersøgelser, der sammenlignede Labazenit med salmeterol alene hos i alt 83 astmapatienter, og én hovedundersøgelse, der sammenlignede Labazenit med budesonid alene hos 375 patienter.
English: The CHMP's main concern was that the study comparing Labazenit with budesonide alone did not prove that the anti-inflammatory effect of Labazenit was sufficient.
Danish: CHMP's hovedbetænkelighed var, at den undersøgelse, hvor Labazenit blev sammenlignet med budesonid alene, ikke viste, at den antiinflammatoriske virkning af Labazenit var tilstrækkelig.
English: The CHMP therefore concluded that the benefits of the medicine had not been shown to outweigh its risks and recommended that it be refused marketing authorisation.
Danish: CHMP konkluderede derfor, at fordelene ved Labazenit ikke var påvist at overstige risiciene, og anbefalede afslag på ansøgningen om markedsføringstilladelse.
English: Labazenit is a medicine that contains the active substances budesonide and salmeterol.
Danish: Labazenit er et lægemiddel, der indeholder de to aktive stoffer budesonid og salmeterol.
English: The primary measures of effectiveness were based on the patients' forced expiratory volumes (FEV1) or peak expiratory flow (PEF) after treatment.
Danish: Virkningen blev først og fremmest bedømt på patienternes forcerede ekspirationsvolumen (FEV1) og maksimalstrøm under udåndingen (PEF) efter behandlingen.
English: The company informed the CHMP that there were no ongoing clinical trials with Labazenit in Europe at the time of the CHMP's opinion.
Danish: Virksomheden har til CHMP oplyst, at der på tidspunktet for udtalelsen fra CHMP ikke var nogen igangværende kliniske undersøgelser med Labazenit i Europa.
English: Salmeterol is a long-acting beta-2 agonist and it works by attaching to receptors known as beta-2 receptors found in the muscles of the airways.
Danish: Salmeterol er en langtidsvirkende beta-2 agonist, der virker ved at bindes til beta-2-receptorer i muskulaturen i luftvejene.
English: When inhaled, it reduces inflammation in the airways, thereby helping to keep the patients' airways clear and allowing them to breathe more easily.
Danish: Når det inhaleres, nedsætter det inflammationen i luftvejene og holder på denne måde luftvejene åbne, så patienten får lettere ved at trække vejret.
English: Labazenit was expected to be used in the treatment of asthma in adults for whom a combination product containing an inhaled corticosteroid and long-acting beta-2 agonist is required.
Danish: Labazenit forventedes anvendt til behandling af astma hos voksne med behov for at anvende et kombinationsprodukt til inhalation, der indeholder et binyrebarkhormon og en langtidsvirkende beta-2agonist.
English: Two larger supportive studies involving 601 patients were also conducted, comparing Labazenit with other corticosteroid-beta-2 agonist combination treatments.
Danish: Der blev desuden gennemført to større støttende undersøgelser med 601 patienter, hvor Labazenit blev sammenlignet med andre kombinationer af et binyrebarkhormon og en beta-2-agonist.
English: When it attaches to these receptors, it causes the muscles to relax, which keeps the airways open and helps with the patient's breathing.
Danish: Når det bindes til receptorerne, får det musklerne til at afslappes, så luftvejene holdes frie, og patienten får lettere ved at trække vejret.
English: In addition, data from another study indicated that lower amounts of budesonide may reach the lungs when Labazenit is used.
Danish: Desuden viste en anden undersøgelse, at Labazenit muligvis tilfører lavere mængder af budesonid.
English: Budesonide is a corticosteroid that works as an anti-inflammatory agent.
Danish: Budesonid er et binyrebarkhormon, der virker antiinflammatorisk (betændelsesdæmpende).
English: Several adverse events were solicited in the clinical studies and are designated with the symbol (
Danish: Flere bivirkninger blev fremprovokeret i de kliniske studier, og de er angivet med symbolet (
English: Date of first authorisation: 06 April 2006 Date of latest renewal: 16 December 2015
Danish: Dato for første markedsføringstilladelse: 6. april 2006 Dato for seneste fornyelse:16. december 2015
English: Complications associated with varicella
Danish: Komplikationer associeret med varicella
English: Seroprotection rates [95% CI]
Danish: Seroprotektionsrater [95 % CI]
English: The appropriate time and number of injections will be determined by your doctor in accordance with official recommendations.
Danish: Tidspunktet for og antallet af indsprøjtninger fastsættes af din læge i henhold til de officielle retningslinjer.
English: The frequency of these adverse events is qualified as "not known" when it cannot be estimated based on the available data.
Danish: Hyppigheden af disse uønskede hændelser er anført som “ikke kendt”, når den ikke kan estimeres ud fra forhåndenværende data.
English: Symptoms may persist for a matter of months or on rare occasions for years.
Danish: Symptomerne kan vare i flere måneder og i sjældne tilfælde i årevis.
English: d. Other special populations
Danish: d. Andre særlige populationer
English: ProQuad should be used in accordance to official recommendations.
Danish: ProQuad skal anvendes i overensstemmelse med de officielle anbefalinger.
English: Cases of herpes zoster in clinical studies
Danish: Tilfælde af herpes zoster i kliniske studier
English: • An allergic reaction to eggs or anything that contained egg.
Danish: • En allergisk reaktion over for æg eller noget, der indeholdt æg.
English: Concomitant use with other vaccines:
Danish: Samtidig brug af andre vacciner:
English: These data were confirmed by a post-marketing observational study sponsored by the U.S. Centers for Disease Control and Prevention.
Danish: Disse data blev bekræftet ved et observationsstudie efter markedsføring, som var sponsoreret af U.S. Centers for Disease Control and Prevention.
English: The antibodies help protect against diseases caused by these viruses.
Danish: Antistofferne er med til at beskytte mod sygdomme, der skyldes disse virus.
English: The vaccine may be administered to persons from 12 months of age.
Danish: Vaccinen kan gives til personer, fra de er 12 måneder.
English: The children in these studies received either the current refrigerator-stable formulation or an earlier formulation of ProQuad.
Danish: Børnene i disse studier fik enten den nuværende køleskabs-stabile formulering eller en tidligere formulering af ProQuad.
English: * See section c c. Description of selected adverse reactions
Danish: * Se afsnit c c. Beskrivelse af udvalgte bivirkninger
English: • Individuals less than 9 months of age
Danish: • Personer yngre end 9 måneder
English: • Individuals with a lowered resistance to diseases.
Danish: • Personer med nedsat modstandskraft over for sygdom.
English: Children in these studies were monitored for six weeks post vaccination.
Danish: Børnene i disse studier blev fulgt i seks uger efter vaccinationen.
English: Even in older women (35 to 45 years), these reactions are generally well tolerated and rarely interfere with normal activities.
Danish: Generelt tåler selv ældre kvinder (35-45 år) reaktionerne godt, og de påvirker sjældent det normale aktivitetsniveau.
English: Vaccination should be postponed during any illness with fever >38.5C.
Danish: Vaccinationen bør udsættes i tilfælde af sygdom med feber >38,5 C.
English: In the absence of compatibility studies, the vaccine must not be mixed with other medicinal products.
Danish: Da der ikke foreligger forligelighedsstudier, må vaccinen ikke blandes med andre lægemidler.
English: Social circumstances Activities of daily living impaired
Danish: Sociale forhold Påvirkning af dagligdagens aktiviteter
English: Your doctor will decide when to give the missed dose.
Danish: Din læge afgør, hvornår den manglende dosis skal gives.
English: Very common (≥1/10); Common (≥1/100, <1/10); Uncommon (≥1/1,000, <1/100); Rare (≥1/10,000, <1/1,000); Not known (cannot be estimated from the available data)
Danish: [Meget almindelig, (≥ 1/10), Almindelig (≥ 1/100, < 1/10), Ikke almindelig (≥ 1/1.000 < 1/100), Sjælden (≥ 1/10.000, < 1/1.000) og Meget sjælden (< 1/10.000), Ikke kendt (kan ikke estimeres ud fra forhåndenværende data)]
English: Read all of this leaflet carefully before you or your child is vaccinated because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du eller dit barn bliver vaccineret, da den indeholder vigtige oplysninger.
English: • Individuals 12 months of age and older
Danish: • Personer 12 måneder og ældre
English: Serologic status may be evaluated to determine whether or not additional doses of vaccine are needed.
Danish: Bestemmelse af serologisk status kan afklare, om der er behov for yderligere doser af vaccinen.
English: Medium 199 with Hanks' Salts Minimum Essential Medium, Eagle (MEM) Neomycin
Danish: Medium 199 med Hanks salte MEM (minimum essential medium), Eagle Neomycin
English: Widespread use of a 2-dose vaccination schedule in the United States and countries such as Finland and Sweden has led to a >99% reduction in the incidence of each of the 3 targeted diseases.
Danish: Udbredelsen af et totrins vaccinationsprogram i USA og lande såsom Finland og Sverige har reduceret incidensen af hver af de tre målsygdomme med >99 %.
English: The safety and efficacy of ProQuad in children under 9 months of age have not been established.
Danish: ProQuads sikkerhed og virkning hos børn under 9 måneder er ikke klarlagt.
English: ProQuad is given by injection as follows:
Danish: ProQuad gives som indsprøjtning som følger:
English: ProQuad is not indicated in this subset of the paediatric population.
Danish: ProQuad er ikke indikeret til denne undergruppe af den pædiatriske population.
English: Breakthrough varicella and zoster cases were usually mild.
Danish: Tilfældene af varicella og zoster var sædvanligvis lette.
English: It is important to use a separate sterile syringe and needle for each individual to prevent transmission of infectious agents from one individual to another.
Danish: Det er vigtigt at anvende en separat steril injektionssprøjte og nål til hver enkelt person for at forebygge transmission af smitsomme stoffer fra den ene til den anden.
English: • If the person to be vaccinated has a weakened immune system because of a disease (including AIDS).
Danish: • Hvis personen, der skal vaccineres, har et svækket immunsystem på grund af sygdom (inklusive aids).
English: It is not known whether ProQuad can cause foetal harm when administered to a pregnant woman or affect reproduction capacity.
Danish: Det vides ikke, om ProQuad kan skade fostret, når det gives til en gravid kvinde, eller om det påvirker reproduktionsevnen.
English: Interference with laboratory tests: see section 4.5.
Danish: Interferens med laboratorietester: se pkt.
English: Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine.
Danish: Der bør altid være umiddelbar adgang til passende medicinsk behandling og overvågning i tilfælde af en sjælden anafylaktisk reaktion efter administration af vaccinen.
English: This vaccine contains a trace amount of neomycin.
Danish: Denne vaccine indeholder spor af neomycin.
English: Following vaccination in children, reactions in joints are generally uncommon (0 to 3%) and of brief duration.
Danish: Efter vaccination af børn er ledreaktioner generelt usædvanlige (0-3 %) og kortvarige.
English: The safety profile post-dose 1 and 2 was generally comparable for all age cohorts.
Danish: Sikkerhedsprofilen efter dosis 1 og 2 var generelt sammenlignelig i alle aldersgrupper.
English: Therefore, administration of any of these products should be avoided within 1 month after a dose of ProQuad unless considered to be essential.
Danish: Derfor bør man undgå administration af ethvert præparat af denne type i 1 måned efter en dosis ProQuad, med mindre det skønnes nødvendigt.
English: Patients with rare hereditary problems of fructose intolerance should not take this vaccine.
Danish: Patienter med arvelig fructoseintolerans bør ikke anvende denne vaccine.
English: Like all vaccines and medicines, this vaccine 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: • If the person to be vaccinated has active untreated tuberculosis.
Danish: • Hvis personen, der skal vaccineres, har aktiv, ubehandlet tuberkulose.
English: Traditional non-clinical studies were not performed, but there are no non-clinical concerns considered relevant to clinical safety beyond data included in other sections of the Summary of Product Characteristics (SmPC).
Danish: Der er ikke udført konventionelle ikke-kliniske studier, men der foreligger ingen ikke-kliniske spørgsmål af relevans for den kliniske sikkerhed ud over de data, der er medtaget i produktresuméets øvrige afsnit.
English: However, the long term effect of varicella vaccination on the incidence of herpes zoster is unknown at present.
Danish: Den langvarige virkning af varicella-vaccinen på incidensen af herpes zoster kendes imidlertid ikke på nuværende tidspunkt.
English: Other side effects have been reported following administration of ProQuad and some of these were serious.
Danish: Der er rapporteret andre bivirkninger efter indgivelse af ProQuad, og nogle af disse var alvorlige.
English: Reconstitution instructions intended for medical and healthcare professionals are included at the end of the leaflet
Danish: Vejledning i rekonstitution af vaccinen beregnet for læger og sundhedspersonale er anført sidst i indlægssedlen
English: • Infants between 9 and 12 months of age: ProQuad may be administered from 9 months of age.
Danish: • Spædbørn mellem 9 og 12 måneder: ProQuad kan indgives fra 9-måneders alderen.
English: Over the 10-year observation period, the cumulative rate of varicella was 7.5% after 1 dose and 2.2% after 2 doses.
Danish: I løbet af den tiårige observationsperiode var den kumulative forekomst af skoldkopper 7,5 % efter 1 dosis og 2,2 % efter 2 doser.
English: Observational studies of long-term effectiveness of varicella vaccine Surveillance data from two U.S. observational effectiveness studies confirmed that widespread varicella vaccination reduces the risk of varicella by approximately 90% and that protection is maintained over at least 15 years both in vaccinated and unvaccinated individuals.
Danish: Observationelle studier af varicella-vaccinens langvarige virkning Overvågningsdata fra to amerikanske observationelle effektivitetsstudier bekræftede, at udbredt varicellavaccination reducerer risikoen for varicella med ca. 90 %, og at beskyttelsen opretholdes i mindst 15 år hos både vaccinerede og ikke-vaccinerede personer.
English: To reconstitute the vaccine, use only the solvent supplied, because it is free of preservatives or other antiviral substances, which might inactivate the vaccine.
Danish: Til rekonstitution af vaccinen må kun anvendes den medfølgende solvens, idet den er uden konserveringsmidler eller andre antivirale stoffer, som kunne inaktivere vaccinen.
English: Tell the doctor if your child has recently received a vaccine or if one is scheduled to be given in the near future.
Danish: Fortæl din læge, hvis dit barn er vaccineret for nylig, eller hvis der er planer om vaccination i den nærmeste fremtid.
English: If you forget to take ProQuad
Danish: Hvis du glemmer at få ProQuad
English: In women, incidence rates for arthritis and arthralgia are generally higher than those seen in children (12 to 20%), and the reactions tend to be more marked and of longer duration.
Danish: Hos kvinder er incidensen af artritis og artralgi generelt højere end hos børn (12-20 %), og reaktionerne synes at være mere markante og vare længere.
English: Results showed a gradual decline of varicella rates by an overall 90% to 95% (approximately 10- to 20-fold) from 1995 to 2009 in all age groups, both in vaccinated and unvaccinated children and adolescents.
Danish: Resultaterne viste et gradvist samlet fald i hyppigheden af varicella på 90 % til 95 % (ca. 10 til 20 gange lavere) fra 1995 til 2009 i alle aldersgrupper, både hos vaccinerede og uvaccinerede børn og unge.
English: Other than the increase in febrile seizure after the first dose, no safety concerns after the first or second dose were identified.
Danish: Bortset fra stigningen i feberkramper efter første dosis, blev der ikke identificeret sikkerhedsmæssige risici efter indgivelse af første eller anden dosis.
English: ProQuad is expected to have no or negligible influence on the ability to drive and use machines.
Danish: Det forventes, at ProQuad har ingen eller ubetydelig indflydelse på evnen til at føre motorkøretøj eller betjene maskiner.
English: Postdose 1 Postdose 2
Danish: Post dosis 1 Post dosis 2
English: Current immunosuppressive therapy (including high doses of corticosteroids) (see section 4.8).
Danish: Aktuel immunsuppressiv behandling (inklusive høje doser af kortikosteroider) (se pkt.
English: Some of these cases may have resulted from unrecognized measles in the first year of life or possibly from the measles vaccination.
Danish: Nogle af disse tilfælde kan skyldes ikke-diagnosticerede mæslinger i barnets første leveår eller eventuelt mæslingevaccinationen.
English: The immunogenicity of the current refrigerator-stable formulation was shown to be similar to the immunogenicity of the earlier formulation of ProQuad six weeks after a single dose of the vaccine.
Danish: Immungeniciteten af den nuværende køleskabs-stabile formulering viste sig at være den samme som immungeniciteten af den tidligere formulering af ProQuad seks uger efter en enkelt dosis af vaccinen.
English: • An infection with Human Immunodeficiency Virus (HIV) without showing symptoms of HIV disease.
Danish: • Er hiv-positiv (hiv = human immundefektvirus) uden symptomer på hiv-infektion.
English: These data also suggest that varicella vaccination may reduce the risk of herpes zoster in vaccinated individuals.
Danish: Disse data tyder også på, at varicellavaccination kan reducere risikoen for herpes zoster hos vaccinerede personer.
English: • If the person to be vaccinated is allergic to any of the components of this vaccine (including neomycin or any of the other ingredients listed in section 6).
Danish: • Hvis personen, der skal vaccineres, er allergisk over for de aktive stoffer eller et af de øvrige indholdsstoffer i denne vaccine (inklusive neomycin eller et af de øvrige indholdsstoffer angivet i afsnit 6).
English: Vaccination may be considered in patients with selected immune deficiencies where the benefits outweigh the risks (asymptomatic HIV patients, IgG subclass deficiencies, congenital neutropenia, chronic granulomatous disease, and complement deficiency diseases).
Danish: Vaccination kan overvejes hos patienter med udvalgte immundefekter, når fordelene opvejer risiciene (asymptomatiske hiv-patienter, IgG-subklasse-defekt, kongenit neutropeni, kronisk granulomatøs sygdom og komplementdefekter).
English: The safety profiles were comparable for the two different formulations after a single dose.
Danish: Sikkerheden af de to forskellige formuleringer var sammenlignelig efter en enkelt dosis.
English: The preferred injection sites are the anterolateral area of the thigh in younger children and the deltoid area in older children, adolescents, and adults.
Danish: De foretrukne injektionssteder er regio femoralis anterior hos yngre børn og regio deltoidea hos ældre børn, unge og voksne.
English: There are insufficient data to support the use of ProQuad with any other vaccines.
Danish: Der foreligger ikke tilstrækkelige data til at understøtte brug af ProQuad sammen med andre vacciner.
English: Children who received a second dose of ProQuad
Danish: Børn, som fik anden dosis ProQuad
English: If you or your child have an allergic reaction, call your doctor right away.
Danish: Hvis du eller dit barn får en allergisk reaktion, skal du omgående søge læge.
English: ProQuad has not been evaluated for potential to impair fertility.
Danish: ProQuad er ikke blevet evalueret med hensyn til potentiel forringelse af fertiliteten.
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE AF DE BIOLOGISK AKTIVE STOFFER OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: In the 30-day timeframe following vaccination, no increased risk of febrile seizures was observed (see section 5.1).
Danish: I perioden 30 dage efter vaccination observeredes der ingen øget risiko for feberkramper (se pkt.
English: Hydrochloric acid (to adjust pH) Sodium hydroxide (to adjust pH) Urea
Danish: Saltsyre (til justering af pH) Natriumhydroxid (til justering af pH) Urinstof
English: Arthralgia and/or arthritis
Danish: Artralgi og/eller artritis
English: There are no long-term data currently available with ProQuad (see section 5.1).
Danish: Der foreligger p.t. ingen langtidsdata for ProQuad (se pkt.
English: Discard if reconstituted vaccine is not used within 30 minutes.
Danish: Den rekonstituerede vaccine bortskaffes, hvis den ikke kan anvendes i løbet af 30 minutter.
English: In a large case-control study, the vaccine was estimated to be 85% effective against all forms of varicella and 97% effective against moderately severe and severe disease.
Danish: I et stort case-kontrolstudie vurderedes vaccinen til at have en effekt på 85 % mod alle former for skoldkopper og 97 % mod moderat til svær sygdom.
English: Method of administration The vaccine is to be injected intramuscularly (IM) or subcutaneously (SC).
Danish: Indgivelsesmåde Vaccinen gives intramuskulært (IM) eller subkutant (SC).
English: • If the person to be vaccinated is receiving treatment or taking medications that may weaken the immune system (except low-dose corticosteroid therapy for asthma or replacement therapy).
Danish: • Hvis personen, der skal vaccineres, er i behandling eller får medicin, der kan svække immunsystemet (undtagen lave doser af kortikosteroider mod astma eller som substitutionsterapi).
English: If the person to be vaccinated has experienced any of the following, talk to the doctor or pharmacist before ProQuad is given:
Danish: Hvis personen, der skal vaccineres, har været udsat for følgende problemer, skal du tale med lægen eller apoteket før vaccination med ProQuad:
English: More than 518 million doses of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. have been distributed worldwide (1978 to 2007).
Danish: Over 518 millioner doser af MFR-vaccinen fremstillet af Merck & Co., Inc. er distribueret på verdensplan (1978-2007).
English: Once vaccinated, the person vaccinated should attempt to avoid for up to 6 weeks following vaccination, whenever possible, close association with the following individuals:
Danish: Når personen er blevet vaccineret, bør vedkommende så vidt muligt i op til 6 uger efter vaccinationen undgå tæt kontakt med følgende personer: