natgillin/translations-raw huggingface dataset:
I begge undersøgelser blev kombinationen af Erbitux med platinbaseret kemoterapi sammenlignet med platinbaseret kemoterapi uden Erbitux.
In both studies, the combination of Erbitux with platinum-based chemotherapy was compared with platinum based chemotherapy without Erbitux.
Erbitux skulle have været anvendt i kombination med platinbaseret kemoterapi (en kombination af lægemidler mod kræft, som omfatter et lægemiddel såsom cisplatin eller carboplatin).
Erbitux was to be used in combination with platinum-based chemotherapy (a combination of anticancer medicines that includes a medicine such as cisplatin or carboplatin).
Virksomheden informerede CHMP om, at afslaget ikke får konsekvenser for patienter, der på nuværende tidspunkt deltager i kliniske undersøgelser med Erbitux.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Erbitux.
Cetuximab er opbygget, så det binder sig til EGFR, der kan findes på overfladen af visse tumorceller.
Cetuximab has been designed to attach to EGFR, which can be found on the surface of some tumour cells.
• ‘pladecelle-'kræft i hoved og hals.
• ‘squamous cell' cancers of the head and neck.
Hvilke konsekvenser har afslaget for patienter, der deltager i kliniske undersøgelser med Erbitux?
What are the consequences of the refusal for patients in clinical trials using Erbitux?
Hvordan forventes Erbitux at virke?
How is Erbitux expected to work?
Erbitux er en opløsning til infusion (drop i en vene), der indeholder det aktive stof cetuximab.
Erbitux is a solution for infusion (drip into a vein) that contains the active substance cetuximab.
Den fuldstændige EPAR for Erbitux findes her.
The full European Public Assessment Report for Erbitux is available here.
CHMP anbefalede derfor at give afslag på ansøgningen om ændring af markedsføringstilladelsen.
Hence, the CHMP recommended that the change to the marketing authorisation be refused.
Erbitux kan anvendes, når kræften er lokalt fremskreden (når tumoren er vokset, men ikke har spredt sig), når kræften er recidiverende
Erbitux can be used when the cancer is locally advanced (when the tumour has grown but has not spread), recurrent (when it has come back after previous treatment) or metastatic.
Ref.: EMEA/756630/2009 EMEA/H/C/264
Ref.: EMA/756630/2009 EMEA/H/C/264
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.
Andre oplysninger om Agenerase:
Other information about Agenerase:
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.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Agenerase.
The Committee recommended that Agenerase be given marketing authorisation.
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 amprenavir EPAR - sammendrag for offentligheden
Agenerase amprenavir EPAR summary for the public
Hvis du ønsker yderligere oplysninger om baggrunden for CHMP's anbefalinger, kan du læse de faglige drøftelser (også en del af denne EPAR).
If you want more information on the basis for the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Agenerase er et lægemiddel, der indeholder det aktive stof amprenavir.
Agenerase is a medicine that contains the active substance amprenavir.
Til børn mellem fire og 12 år og til patienter, der vejer under 50 kg, afhænger den anbefalede dosis Agenerase af legemsvægten.
In children aged between four and 12 years and in patients who weigh less than 50 kg, the recommended dose of Agenerase depends on body weight.
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.
Da amprenavir ikke optages lige så let fra den orale opløsning som fra kapslerne, 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-for-milligram basis.
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.
Den fuldstændige EPAR for Agenerase findes her: her.
The full EPAR for Agenerase can be found here.
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 of Agenerase 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.
Når enzymet blokeres, formerer viruset sig ikke normalt, så infektionen breder sig langsommere.
When the enzyme is blocked, the virus does not reproduce normally, slowing down the spread of infection.
Det aktive stof i Agenerase, amprenavir, er en proteasehæmmer.
The active substance in Agenerase, amprenavir, is a protease inhibitor.
Hvilken risiko er der forbundet med Agenerase?
What is the risk associated with Agenerase?
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).
Hvis patienten ikke skal have ritonavir, skal der bruges større dosis Agenerase (1 200 mg to gange dagligt).
If ritonavir is not used, Agenerase is taken at a higher dose (1,200 mg twice a day).
Ritonavir er en anden proteasehæmmer, der bruges som "forstærker".
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.
Lægen bør først ordinere Agenerase efter at have undersøgt, hvilken antiviral medicin patienten tidligere har fået og efter at have vurderet sandsynligheden for, at medicinen virker på den 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.
I undersøgelsen af voksne, der tidligere havde fået proteasehæmmere, var Agenerase uden ritonavir mere effektivt end placebo men ikke så effektivt som indinavir.
In the studies of adults who had not previously taken protease inhibitors, Agenerase taken without ritonavir was more effective than placebo but less effective than indinavir.
Agenerase bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for amprenavir eller andre af indholdsstofferne.
Agenerase should not be used in people who may be hypersensitive (allergic) to amprenavir or any of the other ingredients.
Den fuldstændige liste over de indberettede bivirkninger for Agenerase fremgår af indlægssedlen.
For the full list of all side effects reported with Agenerase, see the Package Leaflet.
I undersøgelsen af voksne, der tidligere havde fået proteasehæmmere, var Agenerase, forstærket med ritonavir, lige så effektivt som andre proteasehæmmere til at nedsætte virusindholdet efter 16 ugers behandling: Ca. to tredjedele af patienterne i begge grupper havde et virusindhold på mindre end 400 kopier/ml..
In 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.
Agenerase bør kun anvendes til patienter, der tidligere er blevet behandlet med medicin af samme type som Agenerase (proteasehæmmere).
Agenerase should only be used in patients who have previously been treated with the same type of medicine as Agenerase (protease inhibitors).
Hvorfor blev Agenerase godkendt?
Why has Agenerase been approved?
Agenerase anvendes sammen med andre antivirale lægemidler til behandling af patienter over fire år, som er inficeret med humant immundefektvirus type 1(hiv-1).
Agenerase is used in combination with other antiviral medicines to treat patients 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).
Den mindsker nedbrydningshastigheden af amprenavir, der derfor får højere koncentration i blodet.
It slows down the rate at which amprenavir is broken down, increasing the levels of amprenavir in the blood.
De hyppigste bivirkninger ved Agenerase (som optræder hos flere end 1 ud af 10 patienter) er hyperkolesterolæmi (forhøjet koncentration af kolesterol i blodet), hovedpine, diarré, tarmluft, kvalme, opkastning, udslæt og træthed.
The most common side effects with Agenerase (seen in more than 1 patient in 10) are hypercholesterolaemia (high blood cholesterol levels), headache, diarrhoea, flatulence (gas), nausea (feeling sick), vomiting, rash and fatigue (tiredness).
Som med anden hiv-medicin kan patienter, der får Agenerase, få lipodystrofi (ændret fedtfordeling i kroppen), osteonekrose (knoglevævsdød) eller immunreaktiveringssyndrom (infektionslignende symptomer, 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).
Hos 43 heraf var hiv resistent over for fire andre proteasehæmmere.
Of these, 43 had HIV that was resistant to four other protease inhibitors.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Agenerase opvejer risiciene, men at Agenerase ikke er påvist at have nogen fordel, når det anvendes sammen med ritonavir hos patienter, der ikke tidligere har fået proteasehæmmere.
The Committee for Medicinal Products for Human Use (CHMP) decided that Agenerase benefits are greater than its risks, but noted that the benefit of Agenerase taken with ritonavir has not been demonstrated in patients who have not taken protease inhibitors in the past.
På denne måde fås samme virkning med en lavere dosis amprenavir.
This allows a lower dose of amprenavir to be used for the same effect.
Agenerase forstærket med ritonavir må heller ikke anvendes af patienter, der har alvorlige leversygdomme, 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).
Hvad er Agenerase?
What is Agenerase?
Hvilken fordel viser undersøgelserne, at der er ved Agenerase?
What benefit has Agenerase shown during the studies?
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 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.
En fuldstændig liste over sådanne lægemidler fremgår af indlægssedlen.
See the Package Leaflet for the full list of these medicines.
Behandlingens virkning blev hovedsagelig bedømt på den andel af patienterne, hos hvem der efter behandling ikke fandtes påviselige mængder af hiv i blodet og ændringen af virusindholdet i blodet efter behandling.
The main measures of effectiveness were the number of patients with undetectable levels of HIV in the blood (viral load) and the change in viral load after treatment.
Hvad anvendes Agenerase til?
What is Agenerase used for?
Hvordan blev Agenerase undersøgt?
How has Agenerase been studied?
Virkningen af Agenerase forstærket med lave doser af ritonavir blev desuden sammenlignet med virkningen 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.
Amprenavir må ikke anvendes til patienter, der får perikum (et naturlægemiddel, der anvendes til behandling af depression) eller lægemidler, der nedbrydes på samme 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.
Hos børn bør der ikke anvendes ritonavir sammen med Agenerase.
Taking Agenerase with ritonavir should be avoided in children.
Agenerase mindskede også virusindholdet hos børn og unge, selvom meget få af de børn, der tidligere havde fået proteasehæmmere, responderede på behandlingen.
Agenerase reduced viral loads in children and adolescents, although very few of those who had taken protease inhibitors in the past responded to treatment and there were very few children aged below four years.
Hvordan anvendes Agenerase?
How is Agenerase used?
Agenerase er desuden blevet undersøgt hos 268 hiv-inficerede børn og unge i alderen seks måneder til 18 år.
Agenerase without ritonavir has also been studied in 268 HIV-infected children and adolescents aged between six months and 18 years, all of whom had previously taken treatment for HIV infection, and 135 of whom had been treated with protease inhibitors.
Hos patienter med leverproblemer kan anvendelse af Agenerase øge risikoen for leverskade.
Patients who have problems with their liver may be at an elevated risk of liver damage when taking Agenerase.
Patienter, der ikke kan synke kapslerne, kan i stedet anvende Agenerase i oral opløsning.
The oral solution is for patients who cannot swallow the capsules but it cannot be given with ritonavir.
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 som ikke tidligere var blevet behandlet med proteasehæmmere.
Agenerase without ritonavir has also been compared with placebo (a dummy treatment) and with invirase (another protease inhibitor) in 736 HIV-infected adults who had not previously been treated with protease inhibitors.
Hvordan virker Agenerase?
How does Agenerase work?
Til patienter med svære leverproblemer bør Agenerase anvendes uden ritonavir.
The dose of Agenerase should be reduced in patients who have problems with their liver, and it should be taken without ritonavir by patients who have severe liver problems.
6.6 for information om administration.
See section 6.6 for information on administration.
1 gang dagligt
Once Daily
Lyrica og anden medicin kan påvirke hinanden (interaktion).
Lyrica and certain other medicines may influence each other (interaction).
• Din læge vil fortælle, at du enten skal tage Lyrica 2 gange eller 3 gange dagligt.
• Your doctor will tell you to take Lyrica either twice or three times a day.
Hvis du er ældre (over 65 år), skal du tage Lyrica som normalt, medmindre du har nyreproblemer.
If you are an elderly patient (over 65 years of age), you should take Lyrica normally except if you have problems with your kidneys.
Lyrica er ikke beregnet til at blive brugt alene, men skal altid anvendes i kombination med anden behandling mod epilepsi.
Lyrica is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment.
Lyrica bør ikke anvendes under graviditet, medmindre det er klart nødvendigt (hvis fordelene for moderen klart opvejer den mulige risiko for fosteret/det nyfødte barn).
Lyrica should not be used during pregnancy unless clearly necessary (if the benefit to the mother clearly outweighs the potential risk to the foetus).
Underdelen er også mærket med et sort bånd.
The body is also marked with a black band.
Din læge vil udskrive Lyrica til behandling af din epilepsi, hvis din nuværende behandling ikke kan kontrollere din tilstand.
Your doctor will prescribe Lyrica for you to help treat your epilepsy when your current treatment is not controlling your condition.
Biotilgængeligheden af oral pregabalin anslås at være  90%, og er ikke dosisafhængig.
Pregabalin oral bioavailability is estimated to be  90% and is independent of dose.
Oral opløsning Pfizer Service Company Hoge Wei 10
Oral Solution Pfizer Service Company Hoge Wei 10
Fortsæt med at tage Lyrica, indtil din læge beder dig om at stoppe.
Continue taking Lyrica until your doctor tells you to stop.
Pregabalin bindes til en hjælpeundergruppe (2- protein) i de spændingsafhængige calciumkanaler i centralnervesystemet.
Pregabalin binds to an auxiliary subunit (2- protein) of voltage-gated calcium channels in the central nervous system.
Lyrica indeholder en lille mængde alkohol (ethanol), mindre end 100 mg/ml.
Lyrica oral solution contains small amounts of ethanol (alcohol), less than 100 mg/ml.
Lægemidler, der påvirker centralnervesystemet Pregabalin kan potensere virkningerne af ethanol og lorazepam.
Central nervous system influencing medical products Pregabalin may potentiate the effects of ethanol and lorazepam.
Du skal tage Lyrica sammen med din nuværende behandling.
You should take Lyrica in addition to your current treatment.
Lyrica er kun til oral anvendelse.
Lyrica is for oral use only.
Graden af svimmelhed, søvnighed og nedsat koncentrationsevne kan øges, når Lyrica tages sammen med lægemidler, der indeholder:
The degree of dizziness, sleepiness and decreased concentration may be increased if Lyrica is taken together with medicines containing:
473 ml oral opløsning
473 ml oral solution
Lyricas sikkerhed og virkning hos børn under 12 år og unge (12-17 år) er ikke klarlagt.
The safety and efficacy of Lyrica in children below the age of 12 years and in adolescents (12-17 years of age) have not been established.
* Forhøjet alaninaminotransferase (ALAT) og forhøjet aspartataminotransferase (ASAT).
* Alanine aminotransferase increased (ALT) and aspartate aminotransferase increased (AST).
Dette produkt indeholder lactosemonohydrat: Se indlægssedlen for yderligere oplysninger.
This product contains lactose monohydrate: see the package leaflet for further information.
Hvis du har indtryk af, at virkningen af Lyrica er for stærk eller alt for svag, skal du tale med din læge eller apoteket.
If you have the impression that the effect of Lyrica is too strong or too weak, talk to your doctor or pharmacist.
Dato for første markedsføringstilladelse: 6. juli 2004 Dato for seneste fornyelse: 6. juli 2009
Date of first authorisation: 06 July 2004 Date of latest renewal: 06 July 2009
Oxycodon - (smertestillende middel) Lorazepam - (anvendes til behandling af angst) Alkohol
Oxycodone - (used as a pain-killer) Lorazepam - (used for treating anxiety) Alcohol
Samtidig brug af opioider
Concomitant use with opioids
Det er vigtigt, at du tager dine Lyrica kapsler regelmæssigt og på samme tid hver dag.
It is important to take your Lyrica capsules regularly at the same time each day.
Du bør ikke køre bil, betjene indviklede maskiner eller udføre andre aktiviteter, der kan være farlige, før du ved, om denne medicin påvirker din evne til at udføre disse aktiviteter.
You should not drive, operate complex machinery or engage in other potentially hazardous activities until you know whether this medicine affects your ability to perform these activities.
Gentag trin 2 og 4 efter behov for at opnå den nødvendige dosis (tabel 3).
Repeat steps 2 to 4 as needed to achieve the required dose (Table 3).
• En lille andel af de personer, der bliver behandlet med epilepsimedicin som for eksempel Lyrica har haft selvmordstanker eller tanker om at gøre skade på sig selv.
• A small number of people being treated with anti-epileptics such as Lyrica have had thoughts of harming or killing themselves.
Bemærk: Trin 4-7 skal muligvis gentages op til 2 gange for at opnå den totale dosis (se tabel 1).
Note: Steps 4-7 may need to be repeated up to three times to obtain the total dose (Table 1).
Det aktive stof er pregabalin.
The active substance is pregabalin.
Der foreligger ikke tilstrækkelig data om brugen af pregabalin hos gravide.
There are no adequate data from the use of pregabalin in pregnant women.
Disse symptomer kan forekomme oftere eller i en alvorligere grad, hvis du har taget Lyrica i længere tid.
These symptoms may occur more commonly or severely if you have been taking Lyrica for a longer period of time.
I et case-kontrol-studie med opioidbrugere havde patienter, der tog pregabalin samtidig med et opioid, øget risiko for opioidrelateret død sammenlignet med brug af opioider alene (justeret odds ratio [aOR], 1,68 [95 % CI, 1,19 til 2,36]).
In a case-control study of opioid users, those patients who took pregabalin concomitantly with an opioid had an increased risk for opioid-related death compared to opioid use alone (adjusted odds ratio [aOR], 1.68 [95% CI, 1.19 - 2.36]).
Det tilrådes ikke at drikke alkohol, når du tager Lyrica.
It is advised not to drink alcohol while taking Lyrica.
Supplerende dosis efter hæmodialyse (mg) 25 (1,25 ml)
Supplementary dose following haemodialysis (mg) 25 (1.25 ml)
Kunstig jordbærsmag [indeholder små mængder ethanol (alkohol)] Renset vand
Artificial strawberry flavour [contains small amounts of ethanol (alcohol)] Purified water
Hvis dit ansigt eller tunge hæver, eller hvis huden bliver rød og begynder at danne blærer eller skalle af, skal du straks kontakte læge eller skadestue.
If you experience swollen face or tongue or if your skin turns red and starts to blister or peel, you should seek immediate medical advice.
Pfizer Manufacturing Deutschland GmbH Betriebsstätte Freiburg Mooswaldallee 1
Pfizer Manufacturing Deutschland GmbH Betriebsstātte Freiburg Mooswaldallee 1
Tredje optrækning (ml) Ikke nødvendig Ikke nødvendig Ikke nødvendig Ikke nødvendig Ikke nødvendig Ikke nødvendig Ikke nødvendig Ikke nødvendig Ikke nødvendig Ikke nødvendig
Not required Not required Not required
Yderligere bivirkninger, der er rapporteret efter markedsføring, er anført i kursiv i tabellen nedenfor.
Additional reactions reported from postmarketing experience are included in italics in the list below.
Patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption bør ikke anvende denne medicin.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Det er vigtigt, at du tager din Lyrica oral opløsning regelmæssigt og på samme tid hver dag.
It is important to take your Lyrica oral solution regularly at the same time each day.
Medbring pakningen eller flasken med Lyrica oral opløsning.
Take your box or bottle of Lyrica oral solution with you.