natgillin/translations-raw huggingface dataset:
Afslutningsvis bemærkede CHMP, at der ikke blev fremlagt nye data af ansøgeren under proceduren, men var uenig med ansøgeren i, at yderligere data om klinisk effekt og sikkerhed ikke er nødvendige.
In conclusion, the CHMP noted that no new data was provided by the Applicant during the procedure but disagreed with the Applicant point of view that further clinical efficacy and safety data are not needed, indeed the justification relies entirely on a bridging strategy that assumes that the bioavailability obtained with Rapinyl is twice higher than that obtained with Actiq at the same molar dose.
Almindelig: Opkastning, mavesmerter, diaré, obstipation, mavegener, dyspepsi, xerostomi
Common: Vomiting, abdominal pain, diarrhoea, constipation, stomach discomfort, dyspepsia, dry mouth
Rapinyl 800 µg sublinguale resoribletter
Rapinyl 800 µg sublingual tablets
Vedligeholdelsesbehandling:
Maintenance therapy:
Indtagelse af medicinen
Taking the medicine
SÅDAN SKAL DE TAGE RAPINYL
HOW TO TAKE RAPINYL
Vær ekstra forsigtig med at tage Rapinyl
Take special care with Rapinyl
Rapinyl 400 µg sublinguale resoribletter
Rapinyl 400 µg sublingual tablets
SÅDAN OPBEVARER DE RAPINYL
HOW TO STORE RAPINYL
Rapinyl 600 µg sublinguale resoribletter
Rapinyl 600 µg sublingual tablets
Rapinyl 600 mikrogram sublinguale resoribletter
Rapinyl 600 microgram sublingual tablets
Ikke almindelig: Hypoventilation, astma, dyspnø
Respiratory thoracic and mediastinal disorders Uncommon: Hypoventilation, asthma, dyspnoea, Very rare: Apnoea, haemoptysis
Rapinyl 100 µg sublinguale resoribletter
Rapinyl 100 µg sublingual tablets
Rapinyl 800 mikrogram sublinguale resoribletter
Rapinyl 800 microgram sublingual tablets
Rapinyl 300 µg sublinguale resoribletter
Rapinyl 300 µg sublingual tablets
Rapinyl 400 mikrogram sublinguale resoribletter
Rapinyl 400 microgram sublingual tablets
Hjerte
Whereas
Rapinyl 200 µg sublinguale resoribletter
Rapinyl 200 µg sublingual tablets
Hud og subkutane væv
Skin and subcutaneous tissue disorders Very common: Sweating
800 mikrogram fentanyl (som citrat)
800 micrograms fentanyl (as citrate)
Almindelig: Udslæt, pruritus
Skin and subcutaneous tissue disorders Common: Rash, pruritus
200 mikrogram fentanyl (som citrat)
200 micrograms fentanyl (as citrate)
Aktivt stof: Fentanyl.
The active substance is fentanyl.
300 mikrogram fentanyl (som citrat)
300 micrograms fentanyl (as citrate)
400 mikrogram fentanyl (som citrat)
400 micrograms fentanyl (as citrate)
600 mikrogram fentanyl (som citrat)
600 micrograms fentanyl (as citrate)
Resoriblet, sublingual
Sublingual use.
Medlemsstat Indehaver af marketingsgodkendelse
Marketing Authorisation Holder
Rapinyl 200 mikrogram sublinguale resoribletter
Rapinyl 200 microgram sublingual tablets
Ikke almindelig: Uro, depersonalisation, emotionel labilitet
Psychiatric disorders Common: Depression, anorexia, concentration impaired, euphoria
Rapinyl 300 mikrogram sublinguale resoribletter
Rapinyl 300 microgram sublingual tablets
Rapinyl 100 mikrogram sublinguale resoribletter
Rapinyl 100 microgram sublingual tablets
Lad derfor være med at give Rapinyl til andre.
Do not pass it on to others.
EU-nummer (markedsføringstilla delsesnummer)
EU (MA) Number
Bilag I Fortegnelse over lægemidlernes navne, lægemiddelform, styrker, administyrationsvej, indehavere af markedsføringstilladelser i medlemsstaterne
Annex I List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, Marketing Authorisation Holders in the Member States
Sanofi-Aventis Netherlands B.V.
Netherlands Sanofi-Aventis Netherlands B.V.
Kampenringweg 45 D-E Gouda Holland
Kampenringweg 45 D-E Gouda Netherlands
Der blev gennemført fem hovedstudier.
Five main studies were carried out.
Hvert år gennemgår agenturet alle nye oplysninger, der måtte foreligge, og opdaterer om nødvendigt denne oversigt.
Every year, the Agency will review any new information that becomes available and this overview will be updated as necessary.
Det vides endnu ikke, hvor længe beskyttelsen varer.
It is not yet known how long the protection will last.
Imvanex fik en markedsføringstilladelse med gyldighed i hele EU den 31. juli 2013.
Imvanex received a marketing authorisation valid throughout the EU on 31 July 2013.
Kopper blev officielt erklæret udryddet i 1980 med det sidst kendte tilfælde af sygdommen i 1977.
Smallpox was officially declared eradicated in 1980 with the last known case of the disease occurring in 1977.
Imvanex er blevet godkendt under "særlige omstændigheder".
Imvanex has been authorised under ‘exceptional circumstances'.
Yderligere information om Imvanex findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/imvanex.
Further information on Imvanex can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/imvanex.
Vaccinen fås kun på recept.
The vaccine can only be obtained with a prescription.
Det vides dog ikke, hvor længe beskyttelsen varer.
However, the duration of protection is not known.
Denne vaccine vil blive anvendt, når det skønnes nødvendigt for at beskytte mod kopper i henhold til de officielle anbefalinger.
This vaccine will be used when it is considered necessary to protect against smallpox in accordance with official recommendations.
Når personen igen kommer i kontakt med dette eller et lignende virus, vil disse antistoffer sammen med andre komponenter i immunsystemet være i stand til at dræbe viraene og hjælpe med at beskytte mod sygdommen.
When the person comes into contact again with this or a similar virus, these antibodies together with other components of the immune system will be able to kill the viruses and help protect against the disease.
Vacciner virker ved at "lære" immunsystemet, hvordan det skal forsvare sig mod en sygdom.
Vaccines work by ‘teaching' the immune system how to defend itself against a disease.
Det skyldes, at det ikke har været muligt at indhente fyldestgørende oplysninger om Imvanex, fordi sygdommen er sjælden.
This is because it has not been possible to obtain complete information about Imvanex due to the rarity of the disease.
Imvanex (levende modificeret vaccinia Ankara-virus)
Imvanex (live modified vaccinia ankara virus)
Som for alle lægemidler bliver data vedrørende brugen af Imvanex løbende overvåget.
As for all medicines, data on the use of Imvanex are continuously monitored.
De hyppigste bivirkninger ved Imvanex (som kan forekomme hos mere end 1 ud af 10 personer) er hovedpine, kvalme, muskelsmerter (myalgi), træthed og reaktioner på injektionsstedet (smerte, rødme, hævelse, hærdning og kløe).
The most common side effects with Imvanex (which may affect more than 1 in 10 people) are headache, nausea, myalgia (muscle pain), tiredness and injection site reactions (pain, redness, swelling, hardening and itching).
Studierne omfattede over 2.000 voksne, herunder patienter med hiv og atopisk dermatitis (en kløende hudlidelse forårsaget af et overaktivt immunsystem) og personer, der tidligere var blevet vaccineret mod kopper.
The studies involved over 2,000 adults, including patients with HIV and atopic dermatitis (an itchy skin condition caused by an overactive immune system) and people who had been vaccinated against smallpox in the past.
Da Imvanex er blevet godkendt under særlige omstændigheder, vil den virksomhed, der markedsfører Imvanex, fremskaffe data om vaccinens fordele og risici ved at gennemføre observationsstudier med patienter, der får vaccinen, samt hvis der skulle komme et udbrud af sygdommen i fremtiden.
Since Imvanex has been authorised under exceptional circumstances, the company that markets Imvanex will provide data on the vaccine's benefits and risks from observational studies in patients who are given the vaccine, and if ever there is an outbreak of the disease in the future.
I to af studierne blev der specifikt set på effektiviteten af Imvanex som booster.
Two of the studies specifically looked at the effectiveness of Imvanex as a booster.
Imvanex må ikke anvendes til patienter, der er overfølsomme (allergiske) over for det aktive stof eller et af de øvrige stoffer, der findes på sporstofniveau, såsom kyllingeprotein, benzonase og gentamicin.
Imvanex must not be used in patients who are hypersensitive (allergic) to the active substance or any of the substances found at trace levels, such as chicken protein, benzonase and gentamicin.
En oversigt over Imvanex, og hvorfor det er godkendt i EU
An overview of Imvanex and why it is authorised in the EU
Imvanex vil derfor være gavnligt for personer, der ikke må få vacciner med replikerende vira, f.eks. patienter med et svækket immunsystem.
Imvanex would therefore be beneficial for people who cannot be given vaccines containing replicating viruses, such as patients with a weakened immune system.
Hvis du ønsker mere information om anvendelsen af Imvanex, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
For more information about using Imvanex, see the package leaflet or contact your doctor or pharmacist.
Når en person vaccineres, opfatter immunsystemet virusset i vaccinen som "fremmed" og danner antistoffer mod det.
When a person is given the vaccine, the immune system recognises the virus in the vaccine as ‘foreign' and makes antibodies against it.
Andre oplysninger om Imvanex
Other information about Imvanex
I et efterfølgende studie med 433 personer, der ikke var blevet vaccineret før, blev det observeret, at niveauet af beskyttende antistoffer efter vaccination med Imvanex var mindst lige så højt som ved en traditionel koppevaccine.
A subsequent study in 433 people who had not been vaccinated before found that the level of protective antibodies after vaccination with Imvanex was at least as high as with a conventional smallpox vaccine.
De indberettede bivirkninger ved Imvanex vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Imvanex are carefully evaluated and any necessary action taken to protect patients.
Hvis en boosterdosis er nødvendig for personer, der tidligere er blevet vaccineret mod kopper, bør der gives en enkelt 0,5 ml-dosis, undtagen hos patienter med et svækket immunsystem (kroppens naturlige forsvar), der bør have to boosterdoser, hvor den anden dosis gives mindst 28 dage efter den første.
If a booster dose is necessary for those who have been vaccinated against smallpox in the past, a single 0.5 ml dose should be given except for patients with a weakened immune system (the body's natural defences) who should receive two booster doses, with the second dose given at least 28 days after the first.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Imvanex?
What measures are being taken to ensure the safe and effective use of Imvanex?
Vaccinia-virusset i Imvanex kan ikke replikere i humane celler og har derfor mindre sandsynlighed for at give bivirkninger end traditionelle koppevacciner.
The vaccinia virus in Imvanex cannot replicate in human cells and hence is less likely to cause side effects than conventional smallpox vaccines.
Imvanex er en vaccine, der anvendes til beskyttelse mod kopper hos voksne.
Imvanex is a vaccine used to protect against smallpox in adults.
Vacciner indeholdende vaccinia-vira var effektive i kampen mod kopper.
Vaccines containing vaccinia viruses were effective in the campaign to eradicate smallpox.
Det indeholder en levende modificeret form for vaccinia-virus kaldet "vaccinia Ankara", som er i familie med koppevirus.
It contains a live modified form of the vaccinia virus called ‘vaccinia Ankara', which is related to the smallpox virus.
Imvanex indeholder en modificeret form for vaccinia Ankara-virus, som ikke forårsager sygdom hos mennesker, og som ikke kan replikere (formere sig) i menneskeceller.
Imvanex contains a modified form of the vaccinia virus called vaccinia Ankara, which does not cause disease in humans and cannot replicate (reproduce) in human cells.
Hvorfor er Imvanex godkendt i EU?
Why is Imvanex authorised in the EU?
Hvad er Imvanex, og hvad anvendes det til?
What is Imvanex and what is it used for?
Da dette virus ligner koppevirusset, forventes de antistoffer, der produceres mod det, også at beskytte mod kopper.
Because of its similarity to the smallpox virus, antibodies produced against this virus are also expected to protect against smallpox.
Hvilke oplysninger afventes der stadig for Imvanex?
What information is still awaited for Imvanex?
Det Europæiske Lægemiddelagentur vurderer, at Imvanex er effektivt til at anspore til produktion af antistoffer mod kopper i et omfang, som giver en beskyttelse, der er mindst lige så høj som ved traditionelle koppevacciner.
The European Medicines Agency considered that Imvanex is effective at triggering the production of antibodies against smallpox to a level that provides protection at least as high as that from conventional smallpox vaccines.
Hvilke risici er der forbundet med Imvanex?
What are the risks associated with Imvanex?
Det er i studier blevet påvist, at Imvanex er effektivt til at anspore produktion af antistoffer i et omfang, der forventes at yde beskyttelse mod kopper.
Imvanex was shown in studies to be effective at triggering the production of antibodies to a level expected to provide protection against smallpox.
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Imvanex.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Imvanex have been included in the summary of product characteristics and the package leaflet.
Personer, der ikke tidligere er blevet vaccineret mod kopper, bør have to 0,5 ml-doser, hvor den anden dosis gives mindst 28 dage efter den første.
Imvanex is given by injection under the skin, preferably in the upper arm. People who have not been previously vaccinated against smallpox should receive two 0.5 ml doses, with the second dose given at least 28 days after the first.
Hvordan anvendes Imvanex?
How is Imvanex used?
Hvordan virker Imvanex?
How does Imvanex work?
Hvilke fordele viser studierne, at der er ved Imvanex?
What benefits of Imvanex have been shown in studies?
• Bioækvivalens med et EU-referencelægemiddel er blevet påvist på grundlag af relevante data i overensstemmelse med kravene i artikel 10 i direktiv 2001/83/EF (f.eks. en bioækvivalensundersøgelse udført med EU-referencelægemidlet).
• Bioequivalence vis-à-vis an EU reference medicinal product has been demonstrated, based on relevant data, in accordance with the requirements of Article 10 of Directive 2001/83/EC (e.g. a bioequivalence study conducted vis-à-vis the EU reference medicinal product).
Betingelse for at ophæve suspenderingen af markedsføringstilladelserne
Condition for lifting the suspension of the marketing authorisations
For at kunne ophæve suspenderingen af markedsføringstilladelserne i bilag IB skal de kompetente myndigheder i EU's medlemsstater sikre, at nedenstående betingelse er opfyldt af markedsføringstilladelsesindehaveren/-indehaverne.
For the suspension of the marketing authorisations referred to in annex IB to be lifted, the competent authorities of the EU Member States shall ensure that the below condition has been completed by the marketing authorisation holder(s)
Bilag III Betingelse for at ophæve suspenderingen af markedsføringstilladelserne
Annex III Condition for lifting the suspension of the marketing authorisations
Det anvendes sammen med diæt og motion.
It is used in addition to diet and exercise.
Det fås som tabletter (15, 30 og 45 mg).
It is available as tablets (15, 30 and 45 mg).
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Sepioglin den 9. marts 2012.
The European Commission granted a marketing authorisation valid throughout the European Union for Sepioglin on 9 March 2012.
Tabletterne sluges med vand.
The tablets should be swallowed with water.
Den anbefalede startdosis af Sepioglin er 15 eller 30 mg en gang dagligt.
The recommended starting dose of Sepioglin is 15 or 30 mg once a day.
Den fuldstændige EPAR for Sepioglin findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Sepioglin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Sepioglin.
This is a summary of the European public assessment report (EPAR) for Sepioglin.
Andre oplysninger om Sepioglin
Other information about Sepioglin
Det betyder, at Sepioglin er identisk med et ‘referencelægemiddel', som allerede er godkendt i Den Europæiske Union (EU), og som hedder Actos.
This means that Sepioglin is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
Behandlingen med Sepioglin skal tages op til fornyet vurdering efter tre til seks måneder og afbrydes hos patienter, der ikke har tilstrækkelig gavn af behandlingen.
Treatment with Sepioglin should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit.
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 hvordan Sepioglin skal anvendes.
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 Sepioglin.
Hvis du ønsker yderligere oplysninger om behandling med Sepioglin, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Sepioglin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Det aktive stof i Sepioglin, pioglitazon, gør cellerne (fedt, muskel og lever) mere følsomme over for insulin, hvilket betyder, at kroppen bedre udnytter den insulin, den selv danner.
The active substance in Sepioglin, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Denne dosis skal muligvis øges til 45 mg en gang dagligt efter en til to uger, hvis der er behov for en bedre kontrol af glukosekoncentrationen (blodsukkerkoncentrationen) i blodet.
This dose may need to be increased after one or two weeks to up to 45 mg once a day if better blood glucose (sugar) control is needed.
EPAR - sammendrag for offentligheden pioglitazon
EPAR summary for the public pioglitazone
Sepioglin er et ‘generisk lægemiddel'.
Sepioglin is a ‘generic medicine'.
Sepioglin anvendes til behandling af type 2-diabetes hos voksne (på 18 år og derover), især overvægtige.
Sepioglin is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight.
Hvilken fordel og risiko er der forbundet med Sepioglin?
What are the benefits and risks of Sepioglin?
Udvalget anbefalede udstedelse af markedsføringstilladelse for Sepioglin.
The Committee recommended that Sepioglin be given marketing authorisation.
CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Sepioglin er af sammenlignelig kvalitet og er bioækvivalent med Actos.
The CHMP concluded that, in accordance with EU requirements, Sepioglin has been shown to have comparable quality and to be bioequivalent to Actos.
Sepioglin er et lægemiddel, der indeholder det aktive stof pioglitazon.
Sepioglin is a medicine that contains the active substance pioglitazone.
Lægen skal ved efterfølgende kontroller bekræfte, at patienten stadig har gavn af behandlingen.
At subsequent reviews prescribers should confirm that benefits to patients are maintained.
Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Actos.
Therefore, the CHMP's view was that, as for Actos, the benefit outweighs the identified risk.
Sepioglin bør ikke anvendes til patienter i dialyse (en blodrensningsteknik, som anvendes hos personer med nyresygdom).
Sepioglin should not be used in patients on dialysis (a blood clearance technique used in people with kidney disease).
Da Sepioglin er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
Because Sepioglin is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Da Sepioglin er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Actos.
Because Sepioglin is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Hvorfor er Sepioglin blevet godkendt?
Why has Sepioglin been approved?
Sepioglin kan også anvendes sammen med insulin til patienter, som ikke er tilfredsstillende reguleret med insulin alene, og som ikke kan tage metformin.
Sepioglin can also be used together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.
Sepioglin anvendes som enebehandling til patienter, hos hvem metformin (et andet lægemiddel mod diabetes) ikke er egnet.
Sepioglin is used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable.
Hvad er Sepioglin?
What is Sepioglin?
Sepioglin kan desuden anvendes sammen med både metformin og et sulfonylurinstof til patienter, som ikke er tilfredsstillende reguleret trods dobbeltterapi med orale lægemidler (‘tredobbelt terapi').
Sepioglin can also be used together with both metformin and a sulphonylurea in patients who are not satisfactorily controlled despite dual therapy by mouth (‘triple therapy').
Sepioglin kan også anvendes i kombination med metformin til patienter, som ikke er tilfredsstillende reguleret med metformin alene, eller sammen med et sulfonylurinstof (en anden type lægemiddel mod diabetes), hvor metformin ikke er egnet (‘dobbeltterapi').
Sepioglin can also be used in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of antidiabetes medicine) when metformin is not suitable (‘dual therapy').
Hvordan er Sepioglin blevet undersøgt?
How has Sepioglin been studied?
Hvad anvendes Sepioglin til?
What is Sepioglin used for?
Hvordan anvendes Sepioglin?
How is Sepioglin used?
Hvordan virker Sepioglin?
How does Sepioglin work?
1 fyldt pen + 1 fyldt pen
1 pre-filled pen + 1 pre-filled pen
Dette sammendrag blev senest ajourført i 09-2015.
This summary was last updated in 09-2015.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for BeneFIX den 27. august 1997.
The European Commission granted a marketing authorisation valid throughout the European Union for BeneFIX on 27 August 1997.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for BeneFIX.
This document is a summary of the European Public Assessment Report (EPAR) for BeneFIX.
Den fuldstændige EPAR for BeneFIX findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for BeneFIX can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Lægen skal under behandlingen regelmæssigt tage blodprøver for at tilpasse dosen, der skal gives.
During treatment, the doctor should regularly carry out blood tests to adjust the dose to be given.
Ud af 972 infusioner blev 84 % vurderet til at have en "god" eller "særdeles god" virkning.
Out of 972 infusions, 84% were rated as bringing about ‘good' or ‘excellent' responses.
Hos de tidligere behandlede patienter forsvandt 82 % af de 693 blødningsepisoder, der blev behandlet, efter en enkelt infusion af BeneFIX.
In previously treated patients, 82% of the 693 bleeding episodes treated resolved after a single infusion of BeneFIX.