natgillin/translations-raw huggingface dataset:
CHMP konkluderede, at fordelene ved Baraclude opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Baraclude.
The CHMP concluded that Baraclude's benefits are greater than its risks and recommended that it be given marketing authorisation.
Baraclude er et antiviralt lægemiddel, der indeholder det aktive stof entecavir.
Baraclude is an antiviral medicine that contains the active substance entecavir.
Entecavir standser virussets DNA-produktion og forebygger dermed dets formering og spredning.
Entecavir stops the virus making DNA, and prevents it from multiplying and spreading.
Dosen 1 mg anvendes desuden hos voksne med dekompenseret leversygdom, og det frarådes at ophøre med behandlingen hos sådanne patienter.
The 1 mg daily dose is also used in adults with decompensated liver disease and stopping treatment is not recommended in these patients.
Den fuldstændige liste over bivirkninger og begrænsninger ved Baraclude fremgår af indlægssedlen.
For the full list of side effects and restrictions with Baraclude, see the package leaflet.
Hvilken risiko er der forbundet med Baraclude?
What is the risk associated with Baraclude?
I en undersøgelse med 180 børn i alderen 2-18 år med kronisk hepatitis B blev børnene tilfældigt udvalgt til enten at få Baraclude eller virkningsløs behandling (placebo).
In a children's study, 180 children aged 2 to 18 years who had chronic hepatitis B were randomly selected to be given either Baraclude or placebo (a dummy treatment).
Hvis man får 0,5 mg, kan lægemidlet tages sammen med et måltid eller mellem måltiderne, men hvis man får 1 mg, skal det tages mindst to timer før eller to timer efter et måltid.
The 0.5 mg dose can be taken with or without food, but the 1 mg dose must be taken at least 2 hours before or 2 hours after a meal.
Yderligere oplysninger om anvendelsen af lægemidlet til børn fremgår af produktresuméet (også er en del af denne EPAR).
For more information on the use of the medicine in children, see the summary of product characteristics (also part of the EPAR).
Til patienter, som ikke tidligere er blevet behandlet med en nukleosidanalog, anvendes der en dosis på 0,5 mg, mens de, der tidligere har fået lamivudin, men hos hvem dette ikke længere virker, skal have en dosis på 1 mg.
Patients who have not been treated before with a nucleoside analogue receive a 0.5 mg dose, while those who have received lamivudine before but whose infection is no longer responding to it are given a 1 mg dose.
Hvorfor blev Baraclude godkendt?
Why has Baraclude been approved?
Til voksne med kompenseret leversygdom afhænger dosis af, om patienten tidligere er blevet behandlet med et lægemiddel i samme gruppe som Baraclude (en
For adults with compensated liver disease, the dose depends on whether or not the patient has been previously treated with a medicine in the same group as Baraclude
Den tredje undersøgelse blev gennemført med 293 patienter, hos hvem lamivudinbehandling ikke længere virkede.
The third study was carried out in 293 patients whose infection was no longer responding to lamivudine treatment.
Behandling med Baraclude bør iværksættes af en læge med erfaring i behandling af kronisk hepatitis B.
Treatment with Baraclude should be started by a doctor with experience in the management of chronic hepatitis B.
Det er påvist, at Baraclude undertrykker virus hos voksne med både kompenseret og dekompenseret leversygdom.
Baraclude has been shown to be effective at suppressing the virus in adults with both compensated and decompensated liver disease.
I undersøgelserne så man nærmere på, hvordan leverbeskadigelsen havde udviklet sig efter 48 ugers behandling, ved at undersøge prøver af levervæv og ved at måle sygdomstegn såsom leverenzymtal (ALT) eller viralt DNA i blodet.
The studies looked at how the liver damage had evolved after 48 weeks treatment by examining samples of liver tissue and measuring signs of the disease such as the levels of a liver enzyme (ALT) or viral DNA in the blood.
I undersøgelsen blev det registreret, hvor meget virusindholdet i blodet faldt, og hvor mange af patienterne, der udviklede antistoffer mod et virusprotein (e-antigen) og ikke længere havde e-antigen i blodet efter 48 ugers behandling.
The study looked at the reductions in levels of the virus in the blood and the number of patients who developed antibody to a viral protein (known as e-antigen) and no longer had e-antigen in their blood after 48 weeks of treatment.
Baraclude blev også sammenlignet med et andet lægemiddel, adefovir dipivoxil, hos 195 patienter med kronisk hepatitis B med dekompenseret leversygdom.
Baraclude was also compared with another medicine, adefovir dipivoxil, in 195 patients with chronic hepatitis B with decompensated liver disease.
Hos voksne med dekompenseret leversygdom var faldet i viralt DNA større med Baraclude end med adefovir dipivoxil.
In adults with decompensated liver disease, there was a greater reduction in viral DNA with Baraclude than with adefovir dipivoxil.
Baraclude anvendes til behandling af langvarig (kronisk) hepatitis B, der er en smitsom leversygdom forårsaget af hepatitis B-virusset.
Baraclude is used to treat chronic (long-term) hepatitis B (an infectious disease of the liver, caused by the hepatitis B virus).
Baraclude blev sammenlignet med lamivudin i tre hovedundersøgelser af voksne med kronisk hepatitis B, som havde kompenseret leversygdom.
Baraclude was compared with lamivudine in three main studies in adults with chronic hepatitis B who had compensated liver disease.
Der har kunnet iagttages resistens over for entecavir (når et virus ikke længere er følsomt over for det antivirale lægemiddel) hos patienter, som er resistente over for lamivudin.
Resistance to entecavir (when a virus becomes insensitive to the antiviral) has been seen in lamivudine-refractory patients.
Det aktive stof i Baraclude, entecavir, er et antiviralt lægemiddel, der tilhører gruppen af nukleosidanaloger.
The active substance in Baraclude, entecavir, is an antiviral belonging to the class of the nucleoside analogues.
Entecavir hæmmer virkningen af et viralt enzym, DNA-polymerase, som medvirker ved dannelsen af viralt DNA.
Entecavir interferes with the action of a viral enzyme, DNA polymerase, which is involved in the formation of viral DNA.
24 % af børnene i gruppen på Baraclude nåede det primære mål på et indhold af virus-DNA på under 50 IE/ml plus dannelse af antistoffer mod e-antigen og fravær af e-antigen i blodet, sammenholdt med 2 % af børnene i placebogruppen.
Baraclude was also shown to be effective in the children's study: 24% of children in the Baraclude group achieved the primary goal of having a viral DNA level of less than 50 IU/ml plus production of antibody to e-antigen and no e-antigen in their blood compared with 2% of children in the placebo group.
Hvad er Baraclude?
What is Baraclude?
Desuden er det påvist, at det undertrykker virus hos børn.
Viral suppression has also been shown in children.
Hvilken fordel viser undersøgelserne, at der er ved Baraclude?
What benefit has Baraclude shown during the studies?
Hvordan blev Baraclude undersøgt?
How has Baraclude been studied?
Hvad anvendes Baraclude til?
What is Baraclude used for?
Hvordan anvendes Baraclude?
How is Baraclude used?
Leverens tilstand bedredes hos 55 % af de patienter, der blev behandlet med Baraclude, mod 28 % af dem, der blev behandlet med lamivudin.
Baraclude was also more effective than lamivudine in patients refractory to lamivudine: 55% of patients treated with Baraclude had improvements in the condition of their liver, against 28% of those treated with lamivudine.
Hvordan virker Baraclude?
How does Baraclude work?
Ved undersøgelsens slutning havde 55 % af patienterne behandlet med Baraclude både normale ALT
At the end of the study, 55% of the patients treated with Baraclude had both a normal ALT level and undetectable viral DNA in their blood, while 4% of those treated with lamivudine showed the same results.
Der kunne iagttages en forbedring af leverens tilstand hos godt 70 % af patienterne behandlet med Baraclude sammenlignet med godt 60 % af patienterne behandlet med lamivudin.
In adults with compensated liver disease, Baraclude was more effective than lamivudine in patients who had not been treated with nucleoside analogues before: an improvement in the condition of the liver was seen in just over 70% of the patients treated with Baraclude, against just over 60% of the patients treated with lamivudine.
EUs medlemslande skal sikre, at:
The EU Member States shall ensure that:
BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET SOM SKAL IMPLEMENTERES AF MEDLEMSLANDENDE
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
• Anvendelse af antibiotika
• Use of antibiotics
Indehaveren af markedsføringstilladelsen skal sikre, at opdaterede lægeinformationspakker udleveres til alle oftalmologiske afdelinger, hvor Lucentis forventes brugt.
The Marketing Authorisation Holder (MAH) shall ensure that updated physician information packs are provided to all ophthalmology clinics where Lucentis is expected to be used.
• Steril teknikker, inklusiv periokulær og okulær desinfektion til minimering af risiko for infektion.
• Sterile techniques, including periocular and ocular disinfection, to minimise risk of infection
• Hvornår skal man søge hjælp omgående af den behandlende læge
• When to seek urgent attention from the health care provider
Patientinformationspakken bør præsenteres i form af både patientinformationsfoldere og en CD-rom, som indeholder følgende nøgleelementer:
The patient information pack should be provided in the form of both patient information booklets and audio-CD that contain following key elements:
Informationen til lægen bør indeholde følgende nøgleelementer:
The physician information should contain the following key elements:
• Hvad der sker efter behandlingen med Lucentis
• What are the steps following treatment with Lucentis
• Forberedelse til Lucentis behandling
• How to prepare for Lucentis treatment
• Anvendelse af povidon iodid eller tilsvarende
• Use of povidone iodine or equivalent
• Vigtige tegn og symptomer på alvorlige bivirkninger
• Key signs and symptoms of serious adverse events
Lægeinformationspakken skal indeholde følgende:
The physician information pack should contain the following:
• Teknik for den intravitreale injektion
• Techniques for the intravitreal injection
• Vigtige tegn og symptomer af IVT injektionsrelaterede bivirkninger
• Key signs and symptoms of IVT injection related adverse events
• Administrering af IVT injektionsrelaterede bivirkninger
• Management of IVT injection related adverse events
• Informationspakker til patienten
• Patient information packs
• Video om intravitreal injektionsprocedure
• Intravitreal injection procedure video
• Pictogram om intravitreal injektionsprocedure
• Intravitreal injection procedure pictogram
• Patientinformation
• Patient information leaflet
• Produktinformation
• Physician information
Patienterne blev fulgt op i mindst to år.
Patients were followed up for at least two years.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for PhotoBarr den 25. marts 2004.
The European Commission granted a marketing authorisation valid throughout the European Union for PhotoBarr on 25 March 2004.
Efter to år var der stadig den samme forskel mellem de to grupper.
A similar difference was seen between the two groups after two years.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for PhotoBarr.
This is a summary of the European public assessment report (EPAR) for PhotoBarr.
Dette dræber cellerne ved at ødelægge cellernes bestanddele, f.eks. proteiner og DNA.
This kills the cells by reacting with and destroying their components, such as their proteins and DNA.
Dette skal sikre, at alle læger og farmaceuter, som skal ordinere og udlevere lægemidlet, har fået udleveret informationspakker til sundhedspersonale og patienter.
This will ensure that all doctors and pharmacists who will prescribe or dispense the medicine are provided with information packs for healthcare workers and patients.
PhotoBarr natriumporfimer
PhotoBarr porfimer sodium
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 anvendelsesbetingelserne for PhotoBarr.
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 PhotoBarr.
Det indeholder det aktive stof natriumporfimer.
It contains the active substance porfimer sodium.
Patienter, der får PhotoBarr, skal have udleveret et særligt patientinformationskort, der sammenfatter sikkerhedsoplysningerne om lægemidlet.
Patients who receive PhotoBarr must be given a special card that summarises the safety information on the medicine.
Andre oplysninger om PhotoBarr:
Other information about PhotoBarr
CHMP besluttede, at fordelene ved PhotoBarr opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The CHMP decided that PhotoBarr's benefits are greater than its risks and recommended that it be given marketing authorisation.
Når der gives en indsprøjtning af PhotoBarr, bliver porfimer optaget i cellerne i hele kroppen.
When PhotoBarr is injected, porfimer is absorbed into cells throughout the body.
Den fuldstændige EPAR for PhotoBarr findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for PhotoBarr can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Hvis du ønsker yderligere oplysninger om behandling med PhotoBarr, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with PhotoBarr, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Behandlingens virkning blev hovedsagelig bedømt på antallet af patienterne, hos hvem der ikke var dysplasi af høj grad i mindst seks måneder efter det første behandlingsforløb.
The main measure of effectiveness was the number of patients who had no high-grade dysplasia left at least six months after the first course of treatment.
Disse pakker skal indeholde oplysninger om PhotoBarr og om, hvordan lægemidlet anvendes sikkert.
The packs will include information on PhotoBarr and how it should be used safely.
Da antallet af patienter med Barretts øsofagus er lavt, betragtes sygdommen som ‘sjælden', og PhotoBarr blev udpeget som lægemiddel til sjældne sygdomme den 6. marts 2002.
Because the number of patients with Barrett's oesophagus is low, the disease is considered ‘rare', and PhotoBarr was designated an ‘orphan medicine' (a medicine used in rare diseases) on 6 March 2002.
Virksomheden, der fremstiller PhotoBarr, skal udarbejde oplysningsmateriale i samarbejde med medlemsstaternes lægemiddelmyndigheder.
The company that makes PhotoBarr is preparing educational materials in agreement with medicines regulatory authorities in Member States.
Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af PhotoBarr?
What measures are being taken to ensure the safe use of PhotoBarr?
PhotoBarr blev anvendt i én hovedundersøgelse hos 208 patienter, der havde Barretts øsofagus med dysplasi af høj grad.
PhotoBarr has been studied in one main study involving 208 patients who had Barrett's oesophagus with high-grade dysplasia.
Når stoffet belyses med laserlys af en bestemt bølgelængde, bliver det aktiveret og reagerer med ilten i cellerne, så der dannes en meget reaktiv og giftig form for ilt, der kaldes ‘singlet oxygen' (frie iltradikaler).
When it is illuminated with laser light of a specific wavelength, it is activated and reacts with oxygen in the cells to create a highly reactive and toxic type of oxygen called ‘singlet oxygen'.
Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme for PhotoBarr findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The summary of the opinion of the Committee for Orphan Medicinal Products for PhotoBarr can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Da behandlingen medfører synkebesvær med smerter, kvalme og opkastning, bør patienterne i nogle dage efter laserbehandlingen udelukkende indtage flydende føde, i visse tilfælde i indtil fire uger.
Because it causes difficulty swallowing, including pain, nausea and vomiting, patients should only take liquid food for a few days after laser treatment, and for up to four weeks in some cases.
Hvilken risiko er der forbundet med PhotoBarr?
What is the risk associated with PhotoBarr?
Det aktive stof i PhotoBarr, natriumporfimer, er et fotosensibiliserende middel (et stof, der ændrer sig, når det udsættes for lys).
The active substance in PhotoBarr, porfimer sodium, is a photosensitising agent (a substance that changes when exposed to light).
PhotoBarr må også kun anvendes, hvis der øjeblikkeligt kan være erfarent personale og materiale til stede til vurdering og behandling af anafylakse (svær allergisk reaktion).
PhotoBarr should also only be used if experienced staff and material for assessing and treating anaphylaxis (severe allergic reaction) are immediately available.
Fotodynamisk terapi med PhotoBarr bør kun udføres af en læge, der har erfaring i laserbehandling med endoskop (et kikkertrør, der anvendes til at iagttage indre hulrum i kroppen), og som er uddannet i fotodynamisk terapi.
Photodynamic therapy with PhotoBarr should only be carried out or supervised by a doctor who has experience in laser treatment using an endoscope (a thin tube used to look into the body) and who has been trained in photodynamic therapy.
PhotoBarr bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for natriumporfimer og andre porfyriner eller et eller flere af indholdsstofferne.
PhotoBarr should not be used in people who may be hypersensitive (allergic) to porfimer sodium and other porphyrins, or to any of the other ingredients.
Ca. to dage senere belyses hele dysplasiområdet plus en lille del af det normale væv oven og neden for området med laserlys af en bestemt bølgelængde med et lyslederkabel gennem et endoskop.
Around two days later, the dysplasia, plus small areas of normal tissue above and below it, is illuminated with light from a laser at a specific wavelength using a fibre optic cable through an endoscope.
PhotoBarr anvendes til fotodynamisk terapi (behandling med lys) til at fjerne dysplasi af høj grad (abnorme celler med høj risiko for at udvikle sig til kræft) hos patienter med Barretts øsofagus.
PhotoBarr is used in photodynamic therapy (treatment using light) for the ablation (destruction) of high-grade dysplasia (abnormal cells at high risk of turning into cancer) in patients with Barrett's oesophagus.
Hvorfor blev PhotoBarr godkendt?
Why has PhotoBarr been approved?
PhotoBarr er et pulver, der anvendes til fremstilling af en injektionsvæske, opløsning.
PhotoBarr is a powder that is made up into a solution for injection.
PhotoBarr må ikke bruges hos patienter med porfyri (manglende evne til at nedbryde porfyriner), alvorlige problemer med lever eller nyrer, åreknuder i spiserør eller mave, store sår i spiserøret, fistler (abnorme passager) mellem spiserøret og luftrøret eller bronkierne eller formodet beskadigelse af større blodkar.
PhotoBarr must not be used in patients with porphyria (an inability to break down porphyrins), severe problems with the liver or kidneys, varices (swollen veins) in the oesophagus or stomach, large ulcers in the oesophagus, fistulae (abnormal passageways) between the oesophagus and either the trachea (windpipe) or the bronchi (airways in the lungs), or suspected damage to major blood vessels.
Det er en sygdom, hvor mavesyren har ændret slimhinden i nederste del af spiserøret på grund af beskadigelse som følge af mavesyre.
This is a disease where the lining at the lower end of the oesophagus (gullet) has changed because of damage due to acid from the stomach.
De hyppigste bivirkninger ved PhotoBarr (som optræder hos flere end 1 ud af 10 patienter) er udtørring, spiserørsforsnævning, opkastning, synkebesvær, forstoppelse, kvalme, lysoverfølsomhed (reaktioner svarende til solskoldning) og feber.
The most common side effects with PhotoBarr (seen in more than 1 patient in 10) are dehydration, oesophageal stenosis (narrowing of the oesophagus), vomiting, dysphagia (difficulty swallowing), constipation, nausea (feeling sick), photosensitivity reactions (sunburn-like reactions) and pyrexia (fever).
Ved at begrænse belysningen til dysplasiområdet opnår man, at kun disse celler beskadiges.
By restricting the illumination to the area of dysplasia, only cells in this area are damaged, leaving other areas of the body unaffected.
Der kan gives indtil to supplerende behandlingsforløb (hver bestående af én indsprøjtning og en eller to laserbehandlinger) med mindst tre måneders mellemrum.
Up to two additional treatment courses (one injection and one or two laser treatments) can be given, separated by at least three months, as long as the risk of narrowing of the gullet is taken into account.
Virkningerne af fotodynamisk terapi med PhotoBarr anvendt i kombination med omeprazol (et antacidum) blev sammenholdt med virkningerne af omeprazol alene.
The effects of photodynamic therapy with PhotoBarr, used in combination with omeprazole (an antacid medicine), were compared with those of omeprazole alone.
Af de patienter, der fik PhotoBarr i kombination med omeprazol, var 72 % efter seks måneder helt uden dysplasi af høj grad sammenlignet med 31 % af dem, der kun fik omeprazol.
After six months, 72% of the patients using PhotoBarr in combination with omeprazole had no high-grade dysplasia left, compared with 31% of those taking omeprazole alone.
Den fuldstændige liste over indberettede bivirkninger ved PhotoBarr fremgår af indlægssedlen.
For a more complete list of the side effects reported with PhotoBarr, see the package leaflet.
Hvilken fordel viser undersøgelserne, at der er ved PhotoBarr?
What benefit has PhotoBarr shown during the studies?
Når fotodynamisk terapi med PhotoBarr blev anvendt som tillægsbehandling til omeprazol, forsvandt dysplasien hos et øget antal patienter.
Adding photodynamic therapy using PhotoBarr to omeprazole treatment increased the number of patients whose dysplasia was destroyed.
PhotoBarr gives ved forsigtig, langsom indsprøjtning i en vene i en dosis a 2 mg pr. kg legemsvægt i løbet af tre til fem minutter.
Treatment with PhotoBarr is a two-step process: the medicine is given first before it is activated using a laser. PhotoBarr is given by slow, careful injection into a vein at a dose of 2 mg per kilogram body weight over three to five minutes.
Hvad er PhotoBarr?
What is PhotoBarr?
Derfor skal de undgå at udsætte hud og øjne for stærkt lys i indtil tre måneder efter injektionen.
As all patients receiving PhotoBarr become more sensitive to light, they should take care to avoid exposure of their skin and eyes to bright light for at least three months after injection.
Hvordan blev PhotoBarr undersøgt?
How has PhotoBarr been studied?
Hvad anvendes PhotoBarr til?
What is PhotoBarr used for?
Det anvendte apparatur og belysningens varighed afhænger af, hvor stort det syge område er. Om nødvendigt kan der gives endnu en kortvarig laserbehandling to-tre dage senere.
If necessary, patients may receive a second, shorter laser treatment two to three days later.
Hvordan anvendes PhotoBarr?
How is PhotoBarr used?
Hvordan virker PhotoBarr?
How does PhotoBarr work?
Hertil anvendes følgende formel:
Use the following formula:
Udvalget blev desuden anmodet om at anbefale, om markedsføringstilladelserne burde opretholdes, ændres, suspenderes eller inddrages.
The Committee was also asked to recommend whether the marketing authorisations should be maintained, varied, suspended or withdrawn.