natgillin/translations-raw huggingface dataset:
Grundlaget for indbringelsen var harmonisering af produktresuméet, etiketteringen og indlægssedlen På grundlag af den dokumentation, der er forelagt af indehaveren af markedsføringstilladelsen, vurderingsrapporterne fra rapportøren og co-rapportøren samt de faglige drøftelser i udvalget anså CHMP benefit/risk-forholdet for Femara og relaterede navne for positivt.
Having considered the data submitted by the Marketing Authorisation Holder, the rapporteur and co-rapporteur assessment reports and the scientific discussions within the Committee, the CHMP was of the opinion that the benefit-risk ratio of Femara and associated names is favourable.
Femara blev først gang godkendt i EU i 1996 og dispenseres som en filmovertrukken tablet i styrken 2,5 mg. Femara er godkendt til en række indikationer i tilknytning til behandling af brystkræft hos postmenopausale kvinder med progression af sygdommen.
Femara was first approved in the European Union (EU) in 1996 and is available as a 2.5 mg film-coated tablet.
CHMP anså indikationen for at være almindeligt anerkendt og fandt det af hensyn til både virkning og sikkerhed berettiget, at patientens postmenopausale endokrine status bekræftes før initiering af behandlingen, da undersøgelser har vist, at kvinder med artificiel menopausal status ikke nødvendigvis har postmenopausal endokrin status.
The CHMP considered the indication to be well-established and that confirmation of postmenopausal endocrine status of women before initiation of treatment is justified for both efficacy and safety reasons, as studies have shown that women with induced menopausal status may not be of postmenopausal endocrine status.
CHMP var desuden af den opfattelse, at virkningen af letrozol må formodes at være ringere hos kvinder, der er præmenopausale eller perimenopausale.
The CHMP was also of the opinion that there is a concern of reduced efficacy of letrozole in premenopausal or perimenopausal women.
”Punkt 4.1 - Terapeutiske indikationer
“Section 4.1 - Therapeutic indications
• Det produktresumé og den etikettering og indlægsseddel, der er foreslået af indehaveren af markedsføringstilladelsen, blev vurderet på grundlag af den forelagte dokumentation og de videnskabelige drøftelser i udvalget anbefalede CHMP ændring af markedsføringstilladelserne.
• the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holders have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Femara and associated names (see Annex I).
Vedrørende neoadjuverende behandling viser nylige undersøgelser af behandlingsvarigheden, at der efter 4-8 måneder opnås højere responsrate, og at et øget antal patienter bliver egnede til brystbevarende operation.
Regarding neoadjuvant treatment, recent studies investigating duration of therapy show higher response rates and more patients becoming suitable for BCS at 4-8 months, with very little incremental benefit beyond that and that the minimum duration is 4-6 months.
4) Fremskreden mammacancer efter recidiv eller progression af sygdommen hos kvinder, der har naturlig eller artificiel postmenopausal endokrin status og tidligere er blevet behandlet med antiøstrogener.
4) Advanced breast cancer after relapse or disease progression, in women with natural or artificially induced postmenopausal endocrine status, who have previously been treated with anti-oestrogens.
• Indbringelsen vedrørte harmoniseringen af produktresuméet, etiketteringen og indlægssedlen.
• the scope of the referral was the harmonisation of the summary of products characteristics, labelling and package leaflet
CHMP anså indikationen for at være almindeligt anerkendt og konstaterede, at ordlyden var i overensstemmelse med ordlyden i de fleste nationalt godkendte produktresuméer.
The CHMP considered this indication to be well-established and noted that the wording was consistent with the wording in the nationally approved SmPCs.
2) Forlænget adjuverende behandling af hormonafhængig, invasiv mammacancer hos postmenopausale kvinder, som forud har modtaget adjuverende standardbehandling med tamoxifen i fem år.
2) Extended adjuvant treatment of hormone-dependent invasive breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy for 5 years.
• Fremskreden mammacancer efter recidiv eller progression af sygdommen hos kvinder, som har naturlig eller artificiel postmenopausal endokrin status og tidligere er blevet behandlet med antiøstrogener.
Advanced breast cancer after relapse or disease progression, in women with natural or artificially induced postmenopausal endocrine status, who have previously been treated with antioestrogens.
5) Neoadjuverende behandling af hormonreceptorpositiv, HER-2-negativ mammacancer hos postmenopausale kvinder, hvor kemoterapi ikke er hensigtsmæssig og øjeblikkelig operation ikke er indiceret.
5) Neo-adjuvant treatment of postmenopausal women with hormone receptor positive, HER-2 negative breast cancer where chemotherapy is not suitable and immediate surgery not indicated.
• Neoadjuverende behandling af hormonreceptorpositiv, HER-2-negativ mammacancer hos postmenopausale kvinder, hvor kemoterapi ikke er hensigtsmæssig og øjeblikkelig operation ikke er indiceret.
Neo-adjuvant treatment of postmenopausal women with hormone receptor positive, HER-2 negative breast cancer where chemotherapy is not suitable and immediate surgery not indicated.
Punkt 4.2 - Dosering og indgivelsesmåde
Section 4.2 - Posology and Method of Administration
CHMP bemærkede endvidere, at ordlyden var i overensstemmelse med ordlyden i de fleste nationalt godkendte produktresuméer.
The CHMP also noted that the wording was consistent with the wording in most nationally approved SmPCs.
CHMP konstaterede endvidere, at ordlyden i det væsentlige var i overensstemmelse med de nationalt godkendte produktresuméer.
The CHMP also noted that the wording was largely consistent with the nationally approved SmPCs.
• Forlænget adjuverende behandling af hormonafhængig, invasiv mammacancer hos postmenopausale kvinder, som har fået adjuverende standardbehandling med tamoxifen i fem år.
Extended adjuvant treatment of hormone-dependent invasive breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy for 5 years.
1) Adjuverende behandling af hormonreceptorpositiv, invasiv mammacancer i tidligt stadium hos postmenopausale kvinder.
1) Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer.
3) Førstevalgsbehandling af hormonafhængig, fremskreden mammacancer hos postmenopausale kvinder.
3) First-line treatment in postmenopausal women with hormone-dependent advanced breast cancer.
Hvad angår nedsat leverfunktion bemærkede CHMP, at undersøgelserne har vist, at Femara kan anvendes uden risiko ved let til moderat leverinsufficiens, men at der er begrænsede erfaringer ved svært nedsat leverfunktion og hos non-cancer patienter med levercirrose og/eller leverinsufficiens af Child-Pugh klasse C. Da fordobling af eksponeringen for det aktive stof ikke medfører sikkerhedsmæssige betænkeligheder, og da undereksponering bør undgås fordi virkningen er vist at være dosisafhængig, konkluderede CHMP, at dosisjustering ikke er nødvendig for patienter med svært nedsat leverfunktion, men at der bør indsættes en advarsel herom i punkt 4.4.
Regarding hepatic impairment, the CHMP noted that studies have shown that Femara is safe in mild to moderate hepatic insufficiency but that there is limited experience of use in patients with severely impaired hepatic function, non-cancer patients with liver cirrhosis and/or Child-Pugh stage C liver insufficiency.
• Førstevalgsbehandling af hormonafhængig, fremskreden mammacancer hos postmenopausale kvinder.
First-line treatment in postmenopausal women with hormone-dependent advanced breast cancer.
• Adjuverende behandling af hormonreceptorpositiv, invasiv mammacancer i tidligt stadium hos postmenopausale kvinder.
Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer.
Den virksomhed, der ansøgte om tilladelse, er Laboratoires SMB s.a.
The company that applied for authorisation is Laboratoires SMB s.a.
Hvad er Labazenit?
What is Labazenit?
Virkningerne af Labazenit blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Labazenit were first tested in experimental models before being studied in humans.
De to aktive stoffer i Labazenit er velkendte og findes i flere lægemidler, der anvendes til astmabehandling, enten alene eller i kombination med andre lægemidler.
The two active substances in Labazenit are well known and are present in several medicines used to treat asthma, either alone or in combination with other medicines.
Hvad forventedes Labazenit anvendt til?
What was Labazenit expected to be used for?
FEV1 er det maksimale rumfang luft, som en person kan udånde på 1 sekund, mens PEF er den maksimale hastighed, som en person kan udånde luften med.
FEV1 is the maximum volume of air a person can breathe out in one second, while PEF is the maximum speed at which a person can expel air from their lungs.
Det var hensigten, at det skulle leveres som kapsler med inhalationspulver.
It was to be available as capsules containing powder for inhalation.
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.
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.
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.
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.
Hvordan forventes Labazenit at virke?
How is Labazenit expected to work?
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.
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.
CHMP's hovedbetænkelighed var, at den undersøgelse, hvor Labazenit blev sammenlignet med budesonid alene, ikke viste, at den antiinflammatoriske virkning af Labazenit var tilstrækkelig.
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.
CHMP konkluderede derfor, at fordelene ved Labazenit ikke var påvist at overstige risiciene, og anbefalede afslag på ansøgningen om markedsføringstilladelse.
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.
Labazenit er et lægemiddel, der indeholder de to aktive stoffer budesonid og salmeterol.
Labazenit is a medicine that contains the active substances budesonide and salmeterol.
Virkningen blev først og fremmest bedømt på patienternes forcerede ekspirationsvolumen (FEV1) og maksimalstrøm under udåndingen (PEF) efter behandlingen.
The primary measures of effectiveness were based on the patients' forced expiratory volumes (FEV1) or peak expiratory flow (PEF) after treatment.
Virksomheden har til CHMP oplyst, at der på tidspunktet for udtalelsen fra CHMP ikke var nogen igangværende kliniske undersøgelser med Labazenit i Europa.
The company informed the CHMP that there were no ongoing clinical trials with Labazenit in Europe at the time of the CHMP's opinion.
Salmeterol er en langtidsvirkende beta-2 agonist, der virker ved at bindes til beta-2-receptorer i muskulaturen i luftvejene.
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.
Når det inhaleres, nedsætter det inflammationen i luftvejene og holder på denne måde luftvejene åbne, så patienten får lettere ved at trække vejret.
When inhaled, it reduces inflammation in the airways, thereby helping to keep the patients' airways clear and allowing them to breathe more easily.
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.
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.
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.
Two larger supportive studies involving 601 patients were also conducted, comparing Labazenit with other corticosteroid-beta-2 agonist combination treatments.
Når det bindes til receptorerne, får det musklerne til at afslappes, så luftvejene holdes frie, og patienten får lettere ved at trække vejret.
When it attaches to these receptors, it causes the muscles to relax, which keeps the airways open and helps with the patient's breathing.
Desuden viste en anden undersøgelse, at Labazenit muligvis tilfører lavere mængder af budesonid.
In addition, data from another study indicated that lower amounts of budesonide may reach the lungs when Labazenit is used.
Budesonid er et binyrebarkhormon, der virker antiinflammatorisk (betændelsesdæmpende).
Budesonide is a corticosteroid that works as an anti-inflammatory agent.
Flere bivirkninger blev fremprovokeret i de kliniske studier, og de er angivet med symbolet (
Several adverse events were solicited in the clinical studies and are designated with the symbol (
Dato for første markedsføringstilladelse: 6. april 2006 Dato for seneste fornyelse:16. december 2015
Date of first authorisation: 06 April 2006 Date of latest renewal: 16 December 2015
Komplikationer associeret med varicella
Complications associated with varicella
Seroprotektionsrater [95 % CI]
Seroprotection rates [95% CI]
Tidspunktet for og antallet af indsprøjtninger fastsættes af din læge i henhold til de officielle retningslinjer.
The appropriate time and number of injections will be determined by your doctor in accordance with official recommendations.
Hyppigheden af disse uønskede hændelser er anført som “ikke kendt”, når den ikke kan estimeres ud fra forhåndenværende data.
The frequency of these adverse events is qualified as "not known" when it cannot be estimated based on the available data.
Symptomerne kan vare i flere måneder og i sjældne tilfælde i årevis.
Symptoms may persist for a matter of months or on rare occasions for years.
d. Andre særlige populationer
d. Other special populations
ProQuad skal anvendes i overensstemmelse med de officielle anbefalinger.
ProQuad should be used in accordance to official recommendations.
Tilfælde af herpes zoster i kliniske studier
Cases of herpes zoster in clinical studies
• En allergisk reaktion over for æg eller noget, der indeholdt æg.
• An allergic reaction to eggs or anything that contained egg.
Samtidig brug af andre vacciner:
Concomitant use with other vaccines:
Disse data blev bekræftet ved et observationsstudie efter markedsføring, som var sponsoreret af U.S. Centers for Disease Control and Prevention.
These data were confirmed by a post-marketing observational study sponsored by the U.S. Centers for Disease Control and Prevention.
Antistofferne er med til at beskytte mod sygdomme, der skyldes disse virus.
The antibodies help protect against diseases caused by these viruses.
Vaccinen kan gives til personer, fra de er 12 måneder.
The vaccine may be administered to persons from 12 months of age.
Børnene i disse studier fik enten den nuværende køleskabs-stabile formulering eller en tidligere formulering af ProQuad.
The children in these studies received either the current refrigerator-stable formulation or an earlier formulation of ProQuad.
* Se afsnit c c. Beskrivelse af udvalgte bivirkninger
* See section c c. Description of selected adverse reactions
• Personer yngre end 9 måneder
• Individuals less than 9 months of age
• Personer med nedsat modstandskraft over for sygdom.
• Individuals with a lowered resistance to diseases.
Børnene i disse studier blev fulgt i seks uger efter vaccinationen.
Children in these studies were monitored for six weeks post vaccination.
Generelt tåler selv ældre kvinder (35-45 år) reaktionerne godt, og de påvirker sjældent det normale aktivitetsniveau.
Even in older women (35 to 45 years), these reactions are generally well tolerated and rarely interfere with normal activities.
Vaccinationen bør udsættes i tilfælde af sygdom med feber >38,5 C.
Vaccination should be postponed during any illness with fever >38.5C.
Da der ikke foreligger forligelighedsstudier, må vaccinen ikke blandes med andre lægemidler.
In the absence of compatibility studies, the vaccine must not be mixed with other medicinal products.
Sociale forhold Påvirkning af dagligdagens aktiviteter
Social circumstances Activities of daily living impaired
Din læge afgør, hvornår den manglende dosis skal gives.
Your doctor will decide when to give the missed dose.
[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)]
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)
Læs denne indlægsseddel grundigt, inden du eller dit barn bliver vaccineret, da den indeholder vigtige oplysninger.
Read all of this leaflet carefully before you or your child is vaccinated because it contains important information for you.
• Personer 12 måneder og ældre
• Individuals 12 months of age and older
Bestemmelse af serologisk status kan afklare, om der er behov for yderligere doser af vaccinen.
Serologic status may be evaluated to determine whether or not additional doses of vaccine are needed.
Medium 199 med Hanks salte MEM (minimum essential medium), Eagle Neomycin
Medium 199 with Hanks' Salts Minimum Essential Medium, Eagle (MEM) Neomycin
Udbredelsen af et totrins vaccinationsprogram i USA og lande såsom Finland og Sverige har reduceret incidensen af hver af de tre målsygdomme med >99 %.
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.
ProQuads sikkerhed og virkning hos børn under 9 måneder er ikke klarlagt.
The safety and efficacy of ProQuad in children under 9 months of age have not been established.
ProQuad gives som indsprøjtning som følger:
ProQuad is given by injection as follows:
ProQuad er ikke indikeret til denne undergruppe af den pædiatriske population.
ProQuad is not indicated in this subset of the paediatric population.
Tilfældene af varicella og zoster var sædvanligvis lette.
Breakthrough varicella and zoster cases were usually mild.
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.
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.
• Hvis personen, der skal vaccineres, har et svækket immunsystem på grund af sygdom (inklusive aids).
• If the person to be vaccinated has a weakened immune system because of a disease (including AIDS).
Det vides ikke, om ProQuad kan skade fostret, når det gives til en gravid kvinde, eller om det påvirker reproduktionsevnen.
It is not known whether ProQuad can cause foetal harm when administered to a pregnant woman or affect reproduction capacity.
Interferens med laboratorietester: se pkt.
Interference with laboratory tests: see section 4.5.
Der bør altid være umiddelbar adgang til passende medicinsk behandling og overvågning i tilfælde af en sjælden anafylaktisk reaktion efter administration af vaccinen.
Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine.
Denne vaccine indeholder spor af neomycin.
This vaccine contains a trace amount of neomycin.
Efter vaccination af børn er ledreaktioner generelt usædvanlige (0-3 %) og kortvarige.
Following vaccination in children, reactions in joints are generally uncommon (0 to 3%) and of brief duration.
Sikkerhedsprofilen efter dosis 1 og 2 var generelt sammenlignelig i alle aldersgrupper.
The safety profile post-dose 1 and 2 was generally comparable for all age cohorts.
Derfor bør man undgå administration af ethvert præparat af denne type i 1 måned efter en dosis ProQuad, med mindre det skønnes nødvendigt.
Therefore, administration of any of these products should be avoided within 1 month after a dose of ProQuad unless considered to be essential.
Patienter med arvelig fructoseintolerans bør ikke anvende denne vaccine.
Patients with rare hereditary problems of fructose intolerance should not take this vaccine.
Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all vaccines and medicines, this vaccine can cause side effects, although not everybody gets them.
• Hvis personen, der skal vaccineres, har aktiv, ubehandlet tuberkulose.
• If the person to be vaccinated has active untreated tuberculosis.
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.
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).
Den langvarige virkning af varicella-vaccinen på incidensen af herpes zoster kendes imidlertid ikke på nuværende tidspunkt.
However, the long term effect of varicella vaccination on the incidence of herpes zoster is unknown at present.
Der er rapporteret andre bivirkninger efter indgivelse af ProQuad, og nogle af disse var alvorlige.
Other side effects have been reported following administration of ProQuad and some of these were serious.
Vejledning i rekonstitution af vaccinen beregnet for læger og sundhedspersonale er anført sidst i indlægssedlen
Reconstitution instructions intended for medical and healthcare professionals are included at the end of the leaflet
• Spædbørn mellem 9 og 12 måneder: ProQuad kan indgives fra 9-måneders alderen.
• Infants between 9 and 12 months of age: ProQuad may be administered from 9 months of age.
I løbet af den tiårige observationsperiode var den kumulative forekomst af skoldkopper 7,5 % efter 1 dosis og 2,2 % efter 2 doser.
Over the 10-year observation period, the cumulative rate of varicella was 7.5% after 1 dose and 2.2% after 2 doses.