natgillin/translations-raw huggingface dataset:
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95
97
London, den 26. juni 2008 Referencedokument:
Ref.
EMEA/ 545135/ 2008
EMEA/ 306731/ 2008
SPØRGSMÅL OG SVAR I FORBINDELSE MED TILBAGETRÆKNING AF MARKEDSFØRINGSANSØGNINGEN for AFLUNOV Fællesnavn:
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for AFLUNOV Common name:
Præpandemisk influenzavaccine (H5N1) (overfladeantigen, inaktiveret, adjuveret) (A/ VietNam/ 1194/ 2004)
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) (A/ VietNam/ 1194/ 2004)
Novartis Vaccines and Diagnostics S. r. l. meddelte den 13. juni 2008 officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at det ønsker at trække sin ansøgning om en markedsføringstilladelse for Aflunov til profylakse af H5N1 fugleinfluenza hos voksne og ældre tilbage.
On 13 June 2008, Novartis Vaccines and Diagnostics S. r. l. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Aflunov, for the prophylaxis of H5N1 avian influenza in adults and the elderly.
Det består af en suspension til injektion, som indeholder nogle dele (den ydre membran) af influenzavirusstammen A/ VietNam/ 1194/ 2004.
It consists of a suspension for injection that contains some parts (outer membranes) of the influenza (flu) virus strain called A/ VietNam/ 1194/ 2004.
Man havde forventet, at Aflunov skulle anvendes til beskyttelse af voksne og ældre mod influenza forårsaget af H5N1- stammen (type) af influenzavirus A.
Aflunov was expected to be used in adults and the elderly to protect against flu caused by the H5N1 strain (type) of the influenza A virus.
Aflunov er en præpandemisk vaccine.
Aflunov is a ‘ prepandemic’ vaccine.
Udbrud af en influenzapandemi forekommer, når der opstår en ny stamme af en influenzavirus, der let smitter fra menneske til menneske, fordi mennesker ikke er immune over for den.
A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it.
En pandemi kan berøre de fleste lande og regioner i hele verden.
A pandemic can affect most countries and regions around the world.
Sundhedseksperter er bekymrede for, at den næste influenzapandemi kan forårsages af H5N1- stammen af virussen.
Health experts are concerned that the next flu pandemic could be caused by the H5N1 strain of the virus.
Vacciner virker ved at "lære" immunsystemet (kroppens naturlige forsvar), hvordan det skal forsvare kroppen mod sygdommen.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against a disease.
Når man bliver vaccineret, opfatter immunsystemet de dele af influenzavirussen, som vaccinen indeholder, som "fremmede" og producerer antistoffer mod dem.
When a person is given the vaccine, the immune system recognises the parts of the flu virus it contains as ‘ foreign’ and makes antibodies against them.
Aflunov indeholder mindre dele af H5N1- stammen af influenzavirussen.
Aflunov contains small parts of the H5N1 strain of the flu virus.
Derefter blev de ydre membraner, som indeholder "overfladeantigener" (proteiner på virussens ydre membran, som kroppen opfatter som fremmede) udvundet og renset, før de blev tilsat vaccinen.
Then, the outer membranes that contain the ‘ surface antigens’ (proteins on the outer membrane of the virus that the body recognises as foreign) were extracted and purified before being included in the vaccine.
Aflunov indeholder desuden et "adjuvans" (et olieholdigt stof), der forventes at forstærke immunresponsen.
Aflunov also contains an ‘ adjuvant’ (a compound containing oil), which is expected to stimulate a better response.
I dette forsøg blev Aflunovs sikkerhed og dets evne til at stimulere produktionen af antistoffer ("immunogenicitet") sammenlignet med en tilsvarende vaccine mod sæsonbestemt influenza.
It compared Aflunov’ s safety and its ability to stimulate the production of antibodies (‘ immunogenicity’) with those of a similar vaccine against seasonal flu.
Når CHMP har fremsat en udtalelse, går der som regel cirka to måneder, før Europa- Kommissionen udsteder en markedsføringstilladelse.
Following the CHMP’ s opinion, it usually takes around two months for the European Commission to grant a licence.
Hvad var CHMP' s anbefaling på det pågældende tidspunkt?
What was the recommendation of the CHMP at that time?
Baseret på gennemgang af data og virksomhedens svar på CHMP' s liste over spørgsmål på tidspunktet for tilbagetrækning havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Aflunov ikke kunne være blevet godkendt til profylakse af H5N1 fugleinfluenza.
Based on the review of the data and the company’ s response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Aflunov could not have been approved for the prophylaxis of H5N1 avian influenza.
Hvad var CHMP' s største betænkeligheder?
What were the main concerns of the CHMP?
En inspektion af nogle af forsøgslokaliteterne viste, at forsøget ikke var blevet gennemført i overensstemmelse med "god klinisk praksis" (GCP).
An inspection of some of the study sites showed that the study had not been conducted in compliance with ‘ good clinical practice’ (GCP).
Som følge heraf var den kliniske database for vurdering af vaccinens sikkerhed ikke tilstrækkelig til at opfylde kravene i EMEA' s retningslinjer om præpandemiske vacciner.
As a result, the size of the clinical database for the assessment of the vaccine’ s safety was not sufficient to fulfil the requirements of the EMEA’ s guidelines on prepandemic vaccines.
Derfor kunne CHMP ikke på tidspunktet for tilbagetrækningen drage nogen konklusioner om benefit/ risk- forholdet ved Aflunov.
Therefore, at the time of the withdrawal, the CHMP could not conclude on the benefit-risk balance of Aflunov.
Kapsler, bløde Oral anvendelse
Capsule, soft
Flaske (HDPE)
bottle (HDPE)
Hvis du ønsker yderligere oplysninger om baggrunden for CHMP’ s anbefalinger, kan du læse de faglige drøftel - ser (også en del af denne EPAR).
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Det fås som cremefarvede kapsler (50 og 150 mg amprenavir) og som oral opløsning (15 mg/ ml).
It is available as cream capsules (50 and 150 mg) and as an oral solution (15 mg/ ml).
Agenerase er et antiviralt lægemiddel.
Agenerase is an antiviral medicine.
Dette virus er årsag til aids (erhvervet immundefektsyndrom).
It is used in combination with other antiviral medicines to treat adults and children over four years of age who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Agenerase bør kun anvendes til pati - enter, der tidligere er blevet behandlet med medicin af samme type som Agenerase (proteasehæmme - re).
Agenerase should only be used in patients who have previously been treated with the same type of medicine as Agenerase (protease inhibitors).
Til voksne gives Agenerase kapsler sædvanligvis sammen med lave doser af ritonavir (et andet antiviralt lægemiddel).
In adults, Agenerase capsules are usually given with low-dose ritonavir (another antiviral medicine).
Den orale opløsning kan dog ikke gives sammen med ritonavir, da sikkerheden af denne kombination ikke er blevet undersøgt.
Although Agenerase oral solution is available for patients who cannot swallow the capsules, it cannot be given with ritonavir because the safety of this combination has not been assessed.
Lægen bør først ordinere Agenerase efter at have undersøgt, hvilken antiviral medicin patienten tidli - gere har fået og efter at have vurderet sandsynligheden for, at medicinen virker på det pågældende virus.
Doctors should prescribe Agenerase after they have looked at the antiviral medicines the patient has taken before and the likelihood that the virus will respond to the medicine.
Behandling med Agenerase bør startes af en læge med erfaring i behandling af hiv- infektion.
Treatment with Agenerase should be started by a doctor who has experience in the management of HIV infection.
Den anbefalede dosis til patienter over 12 år er 600 mg to gange dagligt, som tages sammen med 100 mg ritonavir to gange dagligt og med andre antivirale lægemidler.
The recommended dose for patients over 12 years of age is 600 mg twice a day, taken with 100 mg ritonavir twice a day and with other antiviral medicines.
Agenerase kan indtages sammen med et måltid eller mellem måltiderne.
Agenerase can be taken with or without food.
Da amprenavir ikke optages lige så let fra den orale opløsning som fra kaps - lerne, kan de to formuleringer ikke erstatte hinanden milligram for milligram.
Because amprenavir is less easily absorbed with the oral solution than with the capsules, the two formulations are not interchangeable on a milligram-by-milligram basis.
Det blokerer et enzym kaldet protea - se, der medvirker ved formeringen af hiv.
It blocks an enzyme called protease, which is involved in the reproduction of HIV.
Ritonavir er en anden proteasehæmmer, der bruges som "for - stærker".
Ritonavir is another protease inhibitor that is used as a ‘ booster’.
Når Agenerase anvendes i kombination med andre antivirale lægemidler, mindsker det hiv- mængden i blodet og holder den nede.
Agenerase, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Agenerase helbreder ikke hiv- infektion eller aids, men kan sinke den skade på immunsystemet og de infektioner og sygdomme, der er forbundet med aids.
Agenerase does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Agenerase har i kombination med andre antivirale lægemidler, men uden ritonavir, været genstand for to hovedundersøgelser af 736 voksne, der var inficeret med hiv og ikke tidligere var blevet behandlet med proteasehæmmere.
Agenerase, in combination with other antiviral medicines but without ritonavir, has been studied in two main studies including 736 HIV-infected adults who had not previously been treated with protease inhibitors.
I undersøgelserne blev Agenerase sammenlignet med placebo (en virkningsløs behandling) og med invirase (en anden proteasehæmmer).
In these studies, Agenerase was compared with placebo (a dummy treatment) and with invirase (another protease inhibitor).
Agenerase er desuden blevet undersøgt hos 268 hiv- inficerede børn i alderen seks måneder til 18 år.
Agenerase has also been studied in 268 HIV-infected children aged between six months and 18 years.
Alle børnene havde tidligere fået medicin mod hiv- infektion, og 135 af dem havde fået proteasehæmmere.
All of the children had previously taken treatment for HIV infection, and 135 of them had been treated with protease inhibitors.
Virkningen af Agenerase forstærket med lave doser af ritonavir blev desuden sammenlignet med virk - ningen af andre proteasehæmmere hos 206 voksne, der tidligere havde fået proteasehæmmere.
Agenerase boosted with low-dose ritonavir has been compared with other protease inhibitors in 206 adults who had taken protease inhibitors in the past.
Hos de 43 var hiv resistent over for fire andre proteasehæmmere.
Of these, 43 had HIV that was resistant to four other protease inhibitors.
Behandlingens virkning blev hovedsagelig bedømt ved den andel af patienterne, hos hvem der efter behandling ikke fandtes påviselige mængder af hiv i blodet.
The main measures of effectiveness were the proportion of patients with undetectable levels of HIV in the blood (viral load) or the change in viral load after treatment.
I undersøgelserne af patienter, der ikke tidligere havde fået proteasehæmmere, opnåede en større del af de patienter, der fik Agenerase, et virusindhold på under 400 kopier/ ml efter 48 uger, end af dem, der fik placebo, men Agenerase var ikke så effektivt som indinavir.
In the studies of patients who had not previously taken protease inhibitors, more patients taking Agenerase had viral loads below 400 copies/ ml than those taking placebo after 48 weeks, but Agenerase was less effective than indinavir.
Agenerase mindskede også virusind - holdet hos børn, selvom meget få af de børn, der tidligere havde fået proteasehæmmere, responderede på behandlingen.
Agenerase also reduced viral loads in children, although very few of the children who had taken protease inhibitors in the past responded to treatment.
I undersøgelserne deltog kun meget få børn under fire år.
The studies included very few children aged below four years.
Patienter, hos hvem hiv var resistent over for fire andre proteasehæmmere, opnåede efter fire uger større fald i virusindholdet ved at få Agenerase kombineret med ritonavir end ved at fortsætte med de proteasehæmmere, de tidligere havde fået:
In the study of adults who had taken protease inhibitors in the past, Agenerase boosted with ritonavir was as effective as other protease inhibitors in reducing viral loads after 16 weeks of treatment: around two thirds of the patients in both groups had viral loads below 400 copies/ ml.
Dette var ikke tilfældet hos nogen af dem, der fortsatte med at tage de samme proteasehæmmere.
In the patients with HIV that was resistant to four other protease inhibitors, patients taking Agenerase with ritonavir had a greater fall in viral load after four weeks than those continuing to take their previous protease inhibitors: half of those taking Agenerase with ritonavir had viral loads below 400 copies/ ml, compared with none of those continuing to take their previous protease inhibitors.
De hyppigste bivirkninger ved Agenerase (som optræder hos flere end 1 ud af 10 patienter) er hoved - pine, diarré, tarmluft, kvalme, opkastning, udslæt og træthed.
The most common side effects with Agenerase (seen in more than 1 patient in 10) are headache, diarrhoea, flatulence (gas), nausea (feeling sick), vomiting, rash and fatigue (tiredness).
Den fuldstændige liste over de indberet - tede bivirkninger for Agenerase fremgår af indlægssedlen.
For the full list of all side effects reported with Agenerase, see the Package Leaflet.
Agenerase bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for ampre - navir eller andre af indholdsstofferne.
Agenerase should not be used in people who may be hypersensitive (allergic) to amprenavir or any of the other ingredients.
Amprenavir må ikke anvendes til patienter, der får perikum (et naturlægemiddel, der anvendes til behandling af depression) eller lægemidler, der nedbrydes på sam - me måde som Agenerase og er skadelige, hvis koncentrationen i blodet bliver for høj.
Agenerase must not be used in patients who are taking St John’ s wort (a herbal preparation used to treat depression) or medicines that are broken down in the same way as Agenerase and are harmful at high levels in the blood.
Agenerase forstærket med ritonavir må heller ikke anvendes af patienter, der har alvorlige leversyg - domme, eller af patienter, der får rifampicin (anvendes til behandling af tuberkulose) eller lægemidler, der nedbrydes på samme måde som ritonavir, f. eks. flecainid og propafenon (anvendes til behandling af uregelmæssig hjerterytme).
Agenerase boosted with ritonavir must not be taken by patients who have severe problems with their liver, or by patients taking rifampicin (used to treat tuberculosis) or medicines that are broken down in the same way as ritonavir, such as flecainide and propafenone (used to correct irregular heartbeat).
Også ved anvendelse af flere andre lægemidler sammen med Agenerase bør forsigtighed udvises.
Caution is needed when Agenerase is taken at the same time as some other medicines.
Som med anden hiv- medicin kan patienter, der får Agenerase, få lipodystrofi (ændret fedtfordeling i kroppen), osteonekrose (knoglevævsdød) eller immunreaktiveringssyndrom (infektionslignende symp - tomer, der skyldes, at immunsystemet genvinder sin funktion).
As with other anti-HIV medicines, patients taking Agenerase may be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
2/ 3 Hvorfor blev Agenerase godkendt?
2/ 3 Why has Agenerase been approved?
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Agenerase op - vejer risiciene, når det anvendes i kombination med andre antiretrovirale lægemidler til behandling af hiv1- inficerede voksne og børn over fire år, som tidligere er behandlet med proteasehæmmere.
The Committee for Medicinal Products for Human Use (CHMP) decided that Agenerase’ s benefits are greater than its risks for use in combination with other antiretroviral agents in the treatment of protease inhibitor experienced HIV-1 infected adults and children above the age of four years.
Udvalget konstaterede imidlertid, at Agenerase ikke er påvist at have nogen fordel, når det anvendes sammen med ritonavir hos patienter, der ikke tidligere har fået proteasehæmmere.
It is normally taken with the pharmacokinetic enhancer ritonavir, but the Committee noted that the benefit of Agenerase taken with ritonavir has not been demonstrated in patients who have not taken protease inhibitors in the past.
Udvalget anbefalede udstedelse af mar - kedsføringstilladelse for Agenerase.
The Committee recommended that Agenerase be given marketing authorisation.
Agenerase blev oprindelig godkendt "under særlige omstændigheder", da der af faglige årsager på godkendelsestidspunktet kun forelå begrænsede oplysninger.
Agenerase was originally authorised under ‘ Exceptional Circumstances’, because, for scientific reasons, limited information was available at the time of approval.
Efter at virksomheden havde forelagt de anmodede supplerende oplysninger, blev de "særlige omstændigheder" ophævet den 10. marts 2004.
As the company had supplied the additional information requested, the ‘ Exceptional Circumstances ’ ended on 10 March 2004.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Agenerase til Glaxo Group Limited den 20. oktober 2000.
The European Commission granted a marketing authorisation valid throughout the European Union for Agenerase to Glaxo Group Limited on 20 October 2000.
Markedsføringstilladelsen blev fornyet den 20. oktober 2005.
The marketing authorisation was renewed on 20 October 2005.
Den fuldstændige EPAR for Agenerase kan ses her.
The full EPAR for Agenerase can be found here.
Dette sammendrag blev sidst ajourført i 11- 2008.
This summary was last updated in 11-2008.
Hjælpestoffer: d- sorbitol (E420)
Excipients: d-sorbitol (E420)
Alle hjælpestoffer er anført under afsnit 6. 1.
For a full list of excipients, see section 6.1.
Aflange, uigennemsigtige, off- white til flødefarvede og mærket "GX CC1".
Oblong, opaque, off-white to cream coloured, printed with ‘ GX CC1’.
Agenerase, i kombination med andre antiretrovirale midler, er indiceret til behandling af HIV- 1 - inficerede voksne og børn over 4 år, som tidligere er behandlet med proteasehæmmere (PI’ er).
Agenerase, in combination with other antiretroviral agents, is indicated for the treatment of protease inhibitor (PI) experienced HIV-1 infected adults and children above the age of 4 years.
Agenerase kapsler bør normalt administreres sammen med en lav dosis af ritonavir for at booste effekten af amprenavir (se afsnit 4. 2 og 4. 5).
Agenerase capsules should normally be administered with low dose ritonavir as a pharmacokinetic enhancer of amprenavir (see sections 4.2 and 4.5).
Valget af amprenavir bør baseres på individuel testning af virusresistens og patientens tidligere behandling (se afsnit 5. 1).
The choice of amprenavir should be based on individual viral resistance testing and treatment history of patients (see section 5.1).
Fordelen ved Agenerase sammen med en booster dosis af ritonavir er ikke påvist hos patienter, som ikke tidligere er behandlet med proteasehæmmere (se afsnit 5. 1).
The benefit of Agenerase boosted with ritonavir has not been demonstrated in PI naïve patients (see section 5.1)
Behandlingen bør indledes af en læge med erfaring i behandling af HIV- infektion.
Therapy should be initiated by a physician experienced in the management of HIV infection.
Agenerase administreres peroralt og kan tages med eller uden mad.
Agenerase is administered orally and can be taken with or without food.
Agenerase kapsler og oral opløsning kan derfor ikke erstatte hinanden på basis af milligram til milligram (se afsnit 5. 2).
Amprenavir is 14% less bioavailable from the oral solution than from the capsules; therefore, Agenerase capsules and Agenerase oral solution are not interchangeable on a milligram per milligram basis (see section 5.2).
Den anbefalede dosis af Agenerase kapsler er 600 mg 2 gange daglig sammen med 100 mg ritonavir 2 gange daglig og i kombination med andre antiretrovirale midler.
Adults and adolescents of 12 years of age and older (greater than 50 kg body weight): the recommended dose of Agenerase capsules is 600 mg twice daily with ritonavir, 100 mg twice daily, in combination with other antiretroviral agents.
Den anbefalede dosis Agenerase kapsler er 20 mg/ kg legemsvægt 2 gange daglig i kombination med andre antiretrovirale midler, uden at den totale daglige dosis overstiger 2400 mg (se afsnit 5. 1).
2 Children (4 to 12 years) and patients less than 50 kg body weight: the recommended dose of Agenerase capsules is 20 mg/ kg body weight twice a day, in combination with other antiretroviral agents, without exceeding a total daily dose of 2400 mg (see section 5.1).
Børn under 4 år:
Children less than 4 years of age:
Agenerase bør ikke anvendes til børn under 4 år p. g. a. manglende dokumentation for sikkerhed og virkning (se afsnit 5. 2).
Agenerase is not recommended in children below 4 years due to lack of data on safety and efficacy (see section 5.2).
Farmakokinetikken, effekten og sikkerheden af amprenavir er ikke undersøgt hos patienter over 65 år (se afsnit 5. 2).
Elderly: the pharmacokinetics, efficacy and safety of amprenavir have not been studied in patients over 65 years of age (see section 5.2).
Dosisjustering vurderes ikke at være nødvendig hos patienter med nedsat nyrefunktion (se afsnit 5. 2).
Renal impairment: no dose adjustment is considered necessary in patients with renal impairment (see section 5.2).
Den primære metaboliseringsvej for amprenavir er via leveren.
Hepatic impairment: the principal route of metabolism of amprenavir is via the liver.
Der kan ikke gives doseringsanbefalinger til børn med nedsat leverfunktion (se afsnit 5. 2).
No dose recommendation can be made in children with hepatic impairment (see section 5.2).
Samtidig administration af ovennævnte bør anvendes med forsigtighed til patienter med mild og moderat nedsat leverfunktion og er kontraindiceret til patienter med svært nedsat leverfunktion (se afsnit 4. 3).
Concomitant administration should be used with caution in patients with mild and moderate hepatic impairment and is contraindicated in patients with severe hepatic impairment (see section 4.3).