natgillin/translations-raw huggingface dataset:
Sivextro fås som et pulver, der anvendes til at fremstille en injektionsvæske, som gives med drop i en vene (infusion), og som tabletter (200 mg).
Sivextro is available as a powder to be made up into a solution for infusion (drip) into a vein and as tablets (200 mg).
En liste over de bakterier, som Sivextro virker mod, findes i produktresuméet, der også er en del af denne EPAR.
A list of bacteria against which Sivextro is active can be found in the summary of product characteristics (also part of the EPAR).
Hvis du ønsker praktisk vejledning om anvendelsen af Sivextro, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Sivextro, patients should read the package leaflet or contact their doctor or pharmacist.
som sædvanlige antibiotika ikke virker mod (såsom meticillinresistente Staphylococcus aureus (MRSA)).
Sivextro has been shown to work against bacteria (such as methicillin resistant Staphylococcus aureus (MRSA)) for which standard antibiotics do not work.
Den fuldstændige liste over indberettede bivirkninger ved Sivextro fremgår af indlægssedlen.
For the full list of all side effects and restrictions with Sivextro, see the package leaflet.
Hvordan anvendes Sivextro?
How is Sivextro used?
Hvilke fordele viser undersøgelserne, at der er ved Sivextro?
What benefits of Sivextro have been shown in studies?
Hvordan virker Sivextro?
How does Sivextro work?
Der skal indsendes en revideret protokol senest 10 dage efter Kommissionens afgørelse.
The submission of a revised protocol should take place within 10 days after the Commission Decision.
Betingelse, der anses for at være af afgørende betydning for en sikker og virkningsfuld brug af lægemidlet, herunder lægemiddelovervågning
Condition considered essential for the safe and effective use of the medicinal product including pharmacovigilance
Der skal udføres et prospektivt observationsstudie for at evaluere ordinationsanbefalingerne for Mifepristone Linepharma til afbrydelse af tidlig graviditet som angivet i udtalelsen.
a prospective observational study aimed to evaluate the prescription recommendations of Mifepristone Linepharma for early pregnancy termination mentioned in the opinion should be performed.
De nationale kompetente myndigheder skal med referencemedlemsstaten som koordinator sikre, at følgende betingelser bliver opfyldt af indehaveren af markedsføringstilladelse:
The National Competent Authorities coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the MAH:
Behandlingen er opdelt i to faser: induktion og konsolidering.
Treatment is divided into 2 phases: induction and consolidation.
Infusionen bør vare én til to timer, men kan vare længere, hvis patienten får visse bivirkninger.
The infusion should last 1 to 2 hours, but it may need to be given for longer if the patient has certain side effects.
Yderligere information vedrørende Arsenic trioxide Accord findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/arsenic-trioxide-accord.
Further information on Arsenic trioxide Accord can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/arsenic-trioxide-accord.
• patienter med akut promyelocyt leukæmi, der ikke har reageret på tidligere behandling med et retinoid eller lægemidler mod kræft, eller når deres sygdom er vendt tilbage efter en sådan behandling.
• Patients with APL whose disease has not responded to previous treatment with a retinoid and cancer medicines, or when their disease has come back after this type of treatment.
Den anbefalede dosis af Arsenic trioxide Accord afhænger af patientens vægt.
The recommended dose of Arsenic trioxide Accord depends on the patient's weight.
Det gives som infusionsvæske (drop) i en vene.
It is given as an infusion (drip) into a vein.
Arsenic trioxide Accord anvendes til behandling af voksne (over 18 år) med akut promyelocyt leukæmi (APL), en sjælden form for leukæmi (kræft i de hvide blodlegemer), som skyldes en genetisk "translokation" (når to kromosomer bytter gener).
Arsenic trioxide Accord is used to treat adults (aged 18 years or over) with acute promyelocytic leukaemia (APL), a rare form of leukaemia (cancer of the white blood cells) caused by a genetic ‘translocation' (when there is a swap of genes between two chromosomes).
Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Arsenic trioxide Accord kan sammenlignes med Trisenox.
The European Medicines Agency concluded that, in accordance with EU requirements, Arsenic trioxide Accord has been shown to be comparable to Trisenox.
Da Arsenic trioxide Accord er et generisk lægemiddel, anses dets fordele og risici for at være de samme som for referencelægemidlet.
Because Arsenic trioxide Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Der var ikke behov for "bioækvivalensstudier" for at undersøge, om Arsenic trioxide Accord optages identisk med referencelægemidlet for at give det samme niveau af det aktive stof i blodet.
There was no need for ‘bioequivalence' studies to investigate whether Arsenic trioxide Accord is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Arsenic trioxide Accord fås kun på recept, og brugen af det bør overvåges af en læge med erfaring i behandling af patienter med akut leukæmi.
Arsenic trioxide Accord can only be obtained with a prescription and its use should be supervised by a doctor who has experience in the management of patients with acute leukaemias.
Der er allerede foretaget studier over det aktive stofs fordele og risici ved godkendt brug med referencelægemidlet, Trisenox, og de behøver ikke blive gentaget for Arsenic trioxide Accord.
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Trisenox, and do not need to be repeated for Arsenic trioxide Accord.
Som for alle lægemidler bliver data vedrørende brugen af Arsenic trioxide Accord løbende overvåget.
As for all medicines, data on the use of Arsenic trioxide Accord are continuously monitored.
De indberettede bivirkninger ved Arsenic trioxide Accord vurderes omhyggeligt, og der tages nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Arsenic trioxide Accord are carefully evaluated and any necessary action taken to protect patients.
Det aktive stof i lægemidlet, arsentrioxid, har været anvendt i lægemidler i mange år, bl.a. til behandling for leukæmi.
The active substance in the medicine, arsenic trioxide, has been used in medicines for many years, including for the treatment of leukaemia.
I konsolideringsfasen gives Arsenic trioxide Accord fem dage om ugen, men varigheden af behandlingen og af pauserne ind imellem forløbene afhænger af, om patienten tidligere har modtaget behandling.
During the consolidation phase, Arsenic trioxide Accord is given on 5 days each week but the length of breaks between courses and how long it is given for depends on whether patients have received previous treatment or not.
Som for alle lægemidler har virksomheden leveret studier vedrørende kvaliteten af Arsenic trioxide Accord.
As for every medicine, the company provided studies on the quality of Arsenic trioxide Accord.
Det betyder, at Arsenic trioxide Accord indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", som allerede er godkendt i EU, og som hedder Trisenox.
This means that Arsenic trioxide Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Trisenox.
Det skyldes, at Arsenic trioxide Accord gives som infusion i en vene, så det aktive stof leveres direkte i blodbanen.
This is because Arsenic trioxide Accord is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
I induktionsfasen gives Arsenic trioxide Accord dagligt, indtil der er tegn på, at behandlingen virker (når knoglemarven er fri for leukæmiceller).
During the induction phase, Arsenic trioxide Accord is given every day until there are signs that the treatment is working (when the bone marrow does not contain any leukaemia cells).
Arsenic trioxide Accord indeholder det aktive stof arsentrioxid og er et "generisk lægemiddel".
Arsenic trioxide Accord contains the active substance arsenic trioxide and is a ‘generic medicine'.
Hvis du ønsker mere information om anvendelsen af Arsenic trioxide Accord, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
For more information about using Arsenic trioxide Accord, see the package leaflet or contact your doctor or pharmacist.
• patienter med nydiagnosticeret lav eller mellemhøj risiko for akut promyelocyt leukæmi, hvor det anvendes sammen med lægemidlet hel-trans-retinsyre
• Patients with newly diagnosed low or intermediate risk APL where it is used together with the medicine all-trans-retinoic acid.
En oversigt over Arsenic trioxide Accord, og hvorfor det er godkendt i EU
An overview of Arsenic trioxide Accord and why it is authorised in the EU
Arsenic trioxide Accord anvendes hos:
Arsenic trioxide Accord is used in:
Andre oplysninger om Arsenic trioxide Accord
Other information about Arsenic trioxide Accord
Hvilke fordele og risici er der forbundet med Arsenic trioxide Accord?
What are the benefits and risks of Arsenic trioxide Accord?
Det var derfor agenturets opfattelse, at fordelene ved Arsenic trioxide Accord opvejer de identificerede risici som for Trisenox, og at det kan godkendes til anvendelse i EU.
Therefore, the Agency's view was that, as for Trisenox, the benefits of Arsenic trioxide Accord outweigh the identified risks and it can be authorised for use in the EU.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Arsenic trioxide Accord?
What measures are being taken to ensure the safe and effective use of Arsenic trioxide Accord?
Hvad er Arsenic trioxide Accord, og hvad anvendes det til?
What is Arsenic trioxide Accord and what is it used for?
Arsenic trioxide Accord (arsentrioxid)
Arsenic trioxide Accord (arsenic trioxide)
Hvorfor er Arsenic trioxide Accord godkendt i EU?
Why is Arsenic trioxide Accord authorised in the EU?
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Arsenic trioxide Accord.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Arsenic trioxide Accord have been included in the summary of product characteristics and the package leaflet.
Hvordan er Arsenic trioxide Accord blevet undersøgt?
How has Arsenic trioxide Accord been studied?
Hvordan anvendes Arsenic trioxide Accord?
How is Arsenic trioxide Accord used?
Hvordan virker Arsenic trioxide Accord?
How does Arsenic trioxide Accord work?
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Insulatard den 7. oktober 2002.
The European Commission granted a marketing authorisation valid throughout the European Union for Insulatard on 7 October 2002.
Den fuldstændige EPAR for Insulatard findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Insulatard can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Andre oplysninger om Insulatard
Other information about Insulatard
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Insulatard.
This is a summary of the European public assessment report (EPAR) for Insulatard.
Der er udarbejdet en risikostyringsplan for at sikre, at Insulatard anvendes så sikkert som muligt.
A risk management plan has been developed to ensure that Insulatard is used as safely as possible.
Det kan gives en eller to gange dagligt med eller uden hurtigtvirkende insulin (i forbindelse med måltider) efter lægens anvisninger.
It can be given once or twice a day, with or without a fast-acting insulin (given at meal times), according to the doctor's recommendation.
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 Insulatard.
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 Insulatard.
Hvis du ønsker yderligere oplysninger om behandling med Insulatard, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Insulatard, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Insulatard?
What measures are being taken to ensure the safe and effective use of Insulatard?
Insulatard anvendes til behandling af diabetes (sukkersyge).
Insulatard is used to treat diabetes.
Hos størstedelen af patienterne blev Insulatard sammenlignet med andre typer human insulin eller insulinanaloger.
In most patients, Insulatard was compared with other types of human insulin or insulin analogues.
Insulatard blev undersøgt i fire kliniske hovedundersøgelser med i alt 557 patienter med type 1diabetes, hvor bugspytkirtlen ikke kan producere insulin (to undersøgelser, som omfattede 81 patienter), eller type 2-diabetes, hvor kroppen ikke er i stand til at udnytte insulin effektivt (to undersøgelser, som omfattede 476 patienter).
Insulatard has been studied in four main clinical trials, which included a total of 557 patients with type 1 diabetes, when the pancreas cannot produce insulin (two studies involving 81 patients), or type 2 diabetes, when the body is unable to use insulin effectively (two studies involving 476 patients).
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Insulatard, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Insulatard, including the appropriate precautions to be followed by healthcare professionals and patients.
Den hyppigste bivirkning ved Insulatard (som optræder hos flere end 1 ud af 10 patienter) er hypoglykæmi (lave blodsukkerniveauer).
The most common side effect with Insulatard (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels).
Insulatard medførte et fald i HbA1c-niveauet, hvilket tyder på, at blodsukkeret var blevet holdt under kontrol på et niveau svarende til det, der var observeret for andre typer human insulin.
Insulatard led to a decrease in the level of HbA1c, indicating that blood sugar levels had been controlled to a similar level to that seen with other human insulins.
Insulatard var effektivt ved såvel type 1- som type 2-diabetes og ved anvendelsen af en standardinjektion eller en af de fyldte penne.
Insulatard was effective for both type 1 and type 2 diabetes, and when using a standard injection or one of the pre-filled pens.
CHMP besluttede, at fordelene ved Insulatard opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Insulatard.
The CHMP decided that Insulatard's benefits are greater than its risks and recommended that it be given marketing authorisation.
Det aktive stof i Insulatard, human insulin, produceres via en metode, der er kendt som "rekombinant teknologi": Insulinet fremstilles af gærceller, der har fået indsat et gen (DNA), som gør dem i stand til at producere insulin.
The active substance in Insulatard, human insulin, is produced by a method known as ‘recombinant technology': the insulin is made by yeast cells into which a gene (DNA) has been introduced, which makes them able to produce insulin.
Insulatard indeholder insulin blandet med et andet stof, protamin, i en form, der kaldes "isofan", som optages langsommere dagen igennem.
Insulatard contains insulin mixed with another substance, protamine, in an ‘isophane' form which is absorbed much more slowly during the day.
Hvilken risiko er der forbundet med Insulatard?
What is the risk associated with Insulatard?
Insulatard er et langtidsvirkende insulin.
Insulatard is a long-acting insulin.
Der blev også gennemført yderligere undersøgelser af 225 patienter, hvor man sammenlignede injektion af Insulatard med kanyle eller med brug af en fyldt pen (InnoLet eller FlexPen).
Further studies were also carried out in 225 patients comparing injecting Insulatard using a syringe, or using a pre-filled pen (InnoLet or FlexPen).
Insulatard er en injektionsvæske, suspension, som indeholder det aktive stof human insulin.
Insulatard is a suspension for injection that contains the active substance human insulin.
Hvorfor blev Insulatard godkendt?
Why has Insulatard been approved?
I undersøgelserne målte man blodsukkeret i fastende tilstand eller mængden af glykosyleret hæmoglobin (HbA1c, et hæmoglobin, som binder glukose til sig).
The studies measured the levels of fasting blood glucose or glycosylated haemoglobin (HbA1c, the haemoglobin in the blood that has glucose attached).
Insulatard gives som injektion under huden i låret, bugvæggen (maveskindet), sædemuskelregionen (ballerne) eller deltamuskelregionen (skulderen).
Insulatard is given by injection under the skin in the thigh, the abdominal wall (at the front of the waist), the gluteal region (buttocks) or the deltoid region (shoulder).
Insulatard er et erstatningsinsulin, der næsten er identisk med det insulin, som produceres af bugspytkirtlen.
Insulatard is a replacement insulin which is very similar to the insulin made by the pancreas.
Det fås som hætteglas, cylinderampuller (Penfill) eller fyldte penne (InnoLet eller FlexPen).
It is available as vials, cartridges (Penfill), or pre-filled pens (InnoLet or FlexPen).
Hvad er Insulatard?
What is Insulatard?
Det giver Insulatard en længerevarende virkning.
This gives Insulatard a longer duration of action.
Hvilken fordel viser undersøgelserne, at der er ved Insulatard?
What benefit has Insulatard shown during the studies?
Hvordan blev Insulatard undersøgt?
How has Insulatard been studied?
Hvad anvendes Insulatard til?
What is Insulatard used for?
Hvordan anvendes Insulatard?
How is Insulatard used?
Hvordan virker Insulatard?
How does Insulatard work?
Du må især ikke få visse vacciner kaldet levende vacciner:
In particular, you must not be given certain vaccines called live vaccines:
Det kan tage 3 til 6 timer og skal muligvis gentages.
This can take 3 to 6 hours and may need to be repeated.
Disse lægemidler kan inkludere:
These other medicines may include:
Smerter i hænder eller fødder.
- Pain in the hands or feet.
TLS, som kan være alvorlig, er lejlighedsvist blevet observeret.
TLS, which may be severe, has occasionally been observed.
- Har fået en stamcelletransplantation inden for de sidste 4 måneder.
- have had a stem cell transplant in the last 4 months.
• Efter behandlingen mens immunsystemet stadig er i færd med at komme sig.
• After treatment while the immune system is recovering.
Dato for første markedsføringstilladelse: 23. august 2018
Date of first authorisation: 23 August 2018
• Kontrollere, om du blev vaccineret inden for de sidste 6 uger eller planlægger at blive vaccineret inden for de næste par måneder.
• Check if you had a vaccination in the previous 6 weeks or are planning to have one in the next few months.
Optøningen bør tage cirka 3 til 5 minutter.
Thawing should take approximately 3 to 5 minutes.
Stråling kan føre til inaktivering af produktet.
Irradiation could lead to inactivation of the product.
• Du vil få en graviditetstest, inden behandlingen startes.
• You will be given a pregnancy test before treatment starts.
En sammenfatning af patientdemografi gives i Tabel 4.
A summary of the patient demographics is provided in Table 4.
Reaktionerne er anført efter systemorganklasse og hyppighed.
These reactions are presented by system organ class and by frequency.
Din læge eller sygeplejerske vil nøje kontrollere, at det er din medicin.
Your doctor or nurse will check carefully that this medicine is yours.
Forsøg ikke selv at behandle dine symptomer med anden medicin.
Do not try to treat your symptoms with other medicines on your own.
YESCARTA må kun gives, hvis resultaterne viser, at du ikke er gravid.
YESCARTA should only be given if the results show you are not pregnant.
En klar til uigennemsigtig, hvid til rød dispersion.
A clear to opaque, white to red dispersion.
En ud af 111 patienter modtog ikke lægemidlet på grund af fejl under fremstillingen.
One out of 111 patients did not receive the product due to manufacturing failure.
Du vil muligvis få medicin for at hjælpe med at forebygge tilstanden.
You may be given medicines to help prevent the condition.
Hvis posen er beskadiget, skal lokale retningslinjer følges (eller kontakt straks Kite).
If the bag is compromised, follow the local guidelines (or immediately contact Kite).
Disse antistoffers indvirkning på virkning eller sikkerhed var ikke mærkbar.
An impact of these antibodies on efficacy or safety was not discernible.
Næsten alle patienter oplevede en vis grad af CRS.
Nearly all patients experienced some degree of CRS.
Gennemsnitlig varighed af respons og gennemsnitlig samlet overlevelse er ikke nået (Tabel 5).
Median duration of response and median overall survival have not been reached (Table 5).
Da dette lægemiddel administreres af kvalificeret sundhedspersonale, er de ansvarlige for korrekt bortskaffelse af produktet.
As this medicine will be given by qualified healthcare professionals, they are responsible for the correct disposal of the product.
Det anvendes til at behandle disse sygdomme, når andre tilgængelige lægemidler ikke længere virker på dig.
It is used to treat these conditions when other available medicines have stopped working for you.
- Bemærker, at symptomerne på din kræft bliver værre.
- notice the symptoms of your cancer are getting worse.
• Se efter tegn på graft-versus-host-sygdom, der kan forekomme efter en transplantation.
• Look for signs of graft-versus-host disease that can happen after a transplant.
Respons og overlevelse efter behandling med tilgængelig standard behandling blev evalueret.
Response and survival after treatment with available standard-of-care therapy was evaluated.
• Aktiv graft-versus-host disease (GVHD).
Active graft-versus-host disease (GVHD).
Monitorering af vitale parametre og organfunktioner skal overvejes afhængig af reaktionens sværhedsgrad.
Monitoring of vital signs and organ functions should be considered depending on the severity of the reaction.
Det er for at hjælpe med forebygge infusionsreaktioner og feber.
This is to help prevent infusion reactions and fever.
Det er for at din læge kan kontrollere, om din behandling virker og hjælpe dig, hvis du har bivirkninger.
This is so your doctor can check if your treatment is working and help you if you have any side effects.
Det mest almindelige infektionssted var i luftvejene.
The most common site of infection was in the respiratory tract.
• Din læge eller sygeplejerske vil give dig en enkelt infusion af YESCARTA i din vene i cirka 30 minutter.
• Your doctor or nurse will give you a single infusion of YESCARTA into your vein for approximately 30 minutes.
Endvidere kan forværring af tilgrundliggende organpatologier forekomme i forbindelse med CRS.
In addition worsening of underlying organ pathologies can occur in the setting of CRS.
Det optøede produkt må ikke nedfryses igen.
Thawed product should not be refrozen.
Resultaterne var overensstemmende mellem patienter med Eastern Cooperative Oncology Group (ECOG) på 0 og 1 og efter køn.
Outcomes were consistent between patients with Eastern Cooperative Oncology Group (ECOG) of 0 and 1 and by sex.
Kite Pharma, Inc. 2355 Utah Avenue El Segundo Californien CA 90245
Kite Pharma, Inc. 2355 Utah Avenue El Segundo California CA 90245