natgillin/translations-raw huggingface dataset:
Rasagiline ratiopharm kan enten anvendes alene eller som tillægsbehandling til levodopa (et andet lægemiddel mod Parkinsons sygdom) hos patienter, der får »fluktuationer« hen mod slutningen af perioden mellem levodopa-doserne.
Rasagiline ratiopharm can be used either alone, or as an add-on to levodopa (another medicine used in Parkinson's disease) in patients who are having ‘fluctuations' towards the end of the period between levodopa doses.
Rasagiline ratiopharm er et lægemiddel til behandling af voksne patienter med Parkinsons sygdom (en fremadskridende hjernesygdom, som medfører rysten, langsomme bevægelser og muskelstivhed).
Rasagiline ratiopharm is a medicine used to treat adults with Parkinson's disease (a progressive brain disorder that causes shaking, slow movement and muscle stiffness).
Der var en tilsvarende mindskelse af tiden i »off-tilstand« hos de patienter, der fik entacapon.
Similar reductions in time spent in the ‘off' state were seen in patients taking entacapone.
Det aktive stof i Rasagiline ratiopharm, rasagilin, er en »monoaminoxidase B-hæmmer«.
The active substance in Rasagiline ratiopharm, rasagiline, is a ‘monoamine oxidase B inhibitor'.
Hos patienter med lettere leverproblemer bør der udvises forsigtighed ved anvendelse af Rasagiline ratiopharm, og hvis leverproblemerne forværres, bør behandlingen ophøre.
Patients with mild liver problems should use Rasagiline ratiopharm with caution and should stop treatment if their liver problems get worse.
I den ene af undersøgelserne resulterede 26-ugers behandling med Rasagiline ratiopharm i et gennemsnitligt fald på 0,13 point på UPDRS-skalaen (en skala til vurdering af symptomer på Parkinsons sygdom) fra en startværdi på 24,69.
In one of the studies, a 26-week treatment with Rasagiline ratiopharm resulted in an average fall of 0.13 points in UPDRS (a standard scale for assessing symptoms of Parkinson's disease) from a starting value of 24.69 compared with a rise of 4.07 points in the patients taking placebo from a starting value of 24.54.
Hvis du ønsker yderligere oplysninger om behandling med Rasagiline ratiopharm, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Rasagiline ratiopharm, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
De skyldes den aftagende virkning af levodopa, når patienten oplever pludselige skift mellem »on-perioder«, hvor patienten kan bevæge sig, og »off-perioder«, hvor patienten har svært ved at bevæge sig.
They are linked to a reduction in the effect of levodopa, when the patient experiences sudden switches between being ‘on' and able to move, and being ‘off' and having difficulty moving about.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Rasagiline ratiopharm?
What measures are being taken to ensure the safe and effective use of Rasagiline ratiopharm?
Rasagiline ratiopharm indeholder det aktive stof rasagilin.
Rasagiline ratiopharm contains the active substance rasagiline.
Andre oplysninger om Rasagiline ratiopharm
Other information about Rasagiline ratiopharm
Rasagiline ratiopharm rasagilin
Rasagiline ratiopharm rasagiline
Hvad er Rasagiline ratiopharm, og hvad anvendes det til?
What is Rasagiline ratiopharm and what is it used for?
Det er ikke en praktisk vejledning i, hvordan Rasagiline ratiopharm bør anvendes.
It is not intended to provide practical advice on how to use Rasagiline ratiopharm.
Hvis du ønsker praktisk vejledning om anvendelsen af Rasagiline ratiopharm, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Rasagiline ratiopharm, patients should read the package leaflet or contact their doctor or pharmacist.
Hvorfor blev Rasagiline ratiopharm godkendt?
Why is Rasagiline ratiopharm approved?
Efter ophør af behandlingen med Rasagiline ratiopharm skal der gå mindst 14 dage før påbegyndelse af behandling med andre MAO-hæmmere eller petidin.
There should be at least 14 days between stopping treatment with Rasagiline ratiopharm and starting treatment with another monoamine-oxidase inhibitor or with pethidine.
Det må heller ikke anvendes sammen med det smertestillende middel petidin.
It must also not be used with pethidine (a painkiller).
Hvilke risici er der forbundet med Rasagiline ratiopharm?
What are the risks associated with Rasagiline ratiopharm?
Den fuldstændige liste over bivirkninger og begrænsninger ved Rasagiline ratiopharm fremgår af indlægssedlen.
For the full list of all side effects and restrictions with Rasagiline ratiopharm, see the package leaflet.
I de to andre undersøgelser blev Rasagiline ratiopharm givet som tillægsbehandling til patienter med sygdom i et senere stadium, som allerede var i behandling med levodopa.
In the two other studies, Rasagiline ratiopharm was given as ‘add-on' to patients with later stage disease who were already being treated with levodopa, and compared with placebo and another medicine entacapone (also used as add-ons).
Den fuldstændige liste over indberettede bivirkninger ved Rasagiline ratiopharm fremgår af indlægssedlen.
For the full list of all side effects reported with Rasagiline ratiopharm, see the package leaflet.
Hvordan anvendes Rasagiline ratiopharm?
How is Rasagiline ratiopharm used?
Hvilke fordele viser undersøgelserne, at der er ved Rasagiline ratiopharm?
What benefits of Rasagiline ratiopharm have been shown in studies?
Hvordan virker Rasagiline ratiopharm?
How does Rasagiline ratiopharm work?
Dette gælder både lægemidler og håndkøbsplantepræparater såsom prikbladet perikum (der anvendes til behandling af depression).
Rasagiline ratiopharm must not be used with other monoamine oxidase inhibitors including medicines and herbal preparations without prescription such as St John's wort (used to treat depression).
Det skyldes, at sammensætningen af
This is because the
Cortacare fik en markedsføringstilladelse med gyldighed i hele EU den 27. august 2018.
Cortacare received a marketing authorisation valid throughout the EU on 27 August 2018.
Yderligere information om Cortacare findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Further information on Cortacare can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Som for alle lægemidler fremlagde virksomheden studier af kvaliteten af Cortacare.
As for every medicine, the company provided studies on the quality of Cortacare.
Andre oplysninger om Cortacare
Other information about Cortacare
Cortacare sprøjtes på det berørte hudområde fra en afstand af ca. 10 cm én gang dagligt i en uge.
Cortacare is sprayed onto the affected area of skin at a distance of about 10 cm once daily for a week.
En oversigt over Cortacare, og hvorfor det er godkendt i EU
An overview of Cortacare and why it is authorised in the EU
Hvilke fordele og risici er der forbundet med Cortacare?
What are the benefits and risks of Cortacare?
Cortacare (hydrocortisonaceponat)
Cortacare (hydrocortisone aceponate)
To sprøjt er nok til at behandle et hudområde på 10 x 10 cm. Der bør udvises omhu for at undgå, at hundens øjne rammes af sprayen.
Two sprays is sufficient to treat an area of skin 10 cm by 10 cm. Care should be taken to avoid spraying the eyes of the dog.
Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Cortacare kan sammenlignes med Cortavance.
The European Medicines Agency concluded that, in accordance with EU requirements, Cortacare has been shown to be comparable to Cortavance.
Dette gør lægemidlet mere effektivt til behandling af hudsygdomme ved lave doser.
This makes the medicine more effective at low doses in skin conditions.
Derved reduceres hævelser, rødme og kløe.
This reduces swelling, redness and itching.
Hydrocortisonen i Cortacare er i en særlig kemisk form (di-ester), der gør lægemidlet i stand til at trænge ind i det ydre lag af huden og blive der i længere tid.
The hydrocortisone in Cortacare is in a special chemical form (di-ester) so the medicine is able to get into the outer layer of the skin and remain there for longer.
Hvordan blev Cortacare undersøgt?
How has Cortacare been studied?
Det indeholder det aktive stof hydrocortisonaceponat.
It contains the active substance hydrocortisone aceponate.
Der var ikke behov for "bioækvivalensstudier" for at undersøge, om Cortacare 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 Cortacare is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Der er allerede foretaget studier af det aktive stofs fordele og risici ved godkendt brug med referencelægemidlet Cortavance, og de behøver ikke at blive gentaget for Cortacare.
Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Cortavance, and do not need to be repeated for Cortacare.
Cortacare er den samme som for referencelægemidlet, og når det sprøjtes på huden, forventes det, at det aktive stof i begge produkter optages på samme måde.
composition of Cortacare is the same as the reference medicine and when sprayed onto the skin, the active substance in both products is expected to be absorbed in the same way.
Hvad er Cortacare, og hvad anvendes det til?
What is Cortacare and what is it used for?
For mere information om brug af Cortacare, se indlægssedlen eller kontakt dyrlægen eller apotekspersonalet.
For more information about using Cortacare, see the package leaflet or contact your veterinarian or pharmacist.
Cortacare er et "hybridt lægemiddel".
Cortacare is a ‘hybrid medicine'.
Cortacare fås som spray og udleveres kun efter recept.
Cortacare is available as a spray and can only be obtained with a prescription.
Hvorfor blev Cortacare godkendt i EU?
Why is Cortacare authorised in the EU?
Referencelægemidlet for Cortacare er Cortavance.
The reference medicine for Cortacare is Cortavance.
Det aktive stof i Cortacare, hydrocortisonaceponat, er en kortikosteroid (steroid), der virker i hudcellerne ved at stoppe frigivelsen af kemiske stoffer, der medvirker ved betændelse.
The active substance in Cortacare, hydrocortisone aceponate, is a corticosteroid or ‘steroid' which acts in the skin cells by stopping the release of chemicals which are involved in inflammation.
Da Cortacare er et hybridt lægemiddel, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
Because Cortacare is a hybrid medicine, its benefits and risks are taken as being the same as the reference medicine's.
Cortacare er et kortikosteroidholdigt veterinærlægemiddel, der anvendes til at behandle hunde med betændt og kløende hud.
Cortacare is a corticosteroid veterinary medicine used to treat inflamed and itchy skin conditions in dogs.
Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Cortacare, herunder passende forholdsregler, som skal følges af sundhedspersoner og den, der er ejer af eller ansvarlig for dyret.
Safety information has been included in the summary of product characteristics and the package leaflet for Cortacare, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Disse forholdsregler er de samme som for referencelægemidlet, eftersom Cortacare er et hybridt lægemiddel.
The precautions are the same as for the reference medicine since Cortacare is a hybrid medicine.
Agenturet var derfor af den opfattelse, at fordelene ved Cortacare opvejer de identificerede risici som for Cortavance, og at det kan godkendes til anvendelse i EU.
Therefore, the Agency's view was that, as for Cortavance, the benefit of Cortacare outweighs the identified risk and it can be authorised for use in the EU.
Hvordan anvendes Cortacare?
How is Cortacare used?
Hvordan virker Cortacare?
How does Cortacare work?
ref. EMA/727640/2009 EMEA/H/C/1057
Ref. EMEA/727640/2009 EMEA/H/C/1057
Det primære effektmål var antallet af patienter, som blev helbredt.
The main measure of effectiveness was the number of patients who were cured.
Hvad er Mersarex?
What is Mersarex?
Det indeholder det aktive stof iclaprim.
It contains the active substance iclaprim.
Spørgsmål og svar vedrørende tilbagetrækningen af ansøgningen om markedsføringstilladelse for Mersarex iclaprim
Questions and answers on the withdrawal of the marketing authorisation application for Mersarex iclaprim
Virksomheden fremlagde resultaterne fra to hovedundersøgelser, der omfattede 991 voksne med komplicerede hud- og bløddelsinfektioner.
The company presented results from two main studies involving 991 adults with complicated infections of the skin and soft tissues.
Virkningerne af Mersarex blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Mersarex were first tested in experimental models before being studied in humans.
Omkring halvdelen af patienterne blev behandlet med Mersarex, mens resten blev behandlet med linezolid (et andet antibiotikum).
Around half of the patients were treated with Mersarex, while the others were treated with linezolid (another antibiotic).
CHMP bemærkede ligeledes, at nogle bakterier allerede har en vis resistens over for antibiotikummet, inden det overhovedet er taget i brug generelt.
The CHMP also noted that some bacteria already show a level of resistance to the antibiotic even before it is in general use.
"Kompliceret" betyder, at infektionen er vanskelig at behandle, fordi den har bredt sig til det dybe væv under huden, fordi operativ behandling kan være nødvendig, eller fordi patienten har andre tilstande, der kan påvirke responsen på behandlingen.
Complicated means that the infection is difficult to treat, because it has spread to the deep tissues below the skin, treatment with surgery might be needed, or the patient has other conditions that might affect the response to treatment.
CHMP havde også betænkeligheder med hensyn til, at lægemidlet kan give bivirkninger, som påvirker hjertet (såsom forlænget QTc-interval, som er en ændring af hjertets elektriske aktivitet) og leveren.
There were also concerns that the medicine may cause side effects affecting the heart (such as QTc interval prolongation, an alteration of the electrical activity of the heart) and the liver.
Undersøgelsen tog sigte på at konstatere, om Mersarex givet i op til 14 dage var lige så effektivt som linezolid.
The study looked at whether Mersarex given for up to 14 days was as good as linezolid.
Bakterierne har brug for dette protein til at producere den aktive form af folinsyre, som de skal bruge til at formere sig.
Bacteria need this protein to produce the active form of folic acid, which they need to multiply.
Det aktive stof i Mersarex, iclaprim, er et antibiotikum, som tilhører gruppen af dihydrofolatreduktaseinhibitorer.
The active substance in Mersarex, iclaprim, is an antibiotic of the group ‘dihydrofolate reductase inhibitors'.
Den 21. oktober 2009 meddelte Arpida A/S officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Mersarex til behandling af voksne med komplicerede hud- og bløddelsinfektioner.
On 21 October 2009, Arpida A/S officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Mersarex, for the treatment of adults with complicated skin and soft tissue infections.
Hvad forventedes Mersarex anvendt til?
What was Mersarex expected to be used for?
CHMP var af den opfattelse, at resultaterne ikke viste, at Mersarex var lige så effektivt som sammenligningslægemidlet, og at dataene fra de kliniske undersøgelser var utilstrækkelige til at begrunde den dosering, som virksomheden havde foreslået.
The CHMP was of the opinion that the results did not show that Mersarex was as good as the comparator medicine and that there were insufficient data from clinical studies to justify the dosage proposed by the company.
Det forventedes at virke ved at hæmme virkningen af et bakterieprotein, der hedder dihydrofolatreduktase.
It was expected to work by blocking the action of a bacterial protein called dihydrofolate reductase.
Ved at hæmme virkningen af dihydrofolatreduktase forventedes lægemidlet at hæmme bakteriernes vækst og spredning.
By blocking the action of dihydrofolate reductase, the medicine was expected to slow down the growth and spread of the bacteria.
På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Mersarex ikke kunne have været godkendt til behandling af komplicerede hud- og bløddelsinfektioner.
Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Mersarex could not have been approved for the treatment of complicated infections of the skin and the soft tissues.
Hvordan forventedes Mersarex at virke?
How was Mersarex expected to work?
Mersarex er et koncentrat til infusionsvæske, opløsning (drop i en vene).
Mersarex is a concentrate for solution for infusion (drip into a vein).
Mersarex forventedes anvendt til behandling af infektioner i huden og det underliggende bløde væv.
Mersarex was expected to be used to treat complicated infections of the skin and the ‘soft tissues' below the skin.
Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Mersarex eller i programmer for anvendelse af Mersarex med særlig udleveringstilladelse?
What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Mersarex?
Virksomheden har informeret CHMP om, at der ikke er nogen patienter, som nu deltager i kliniske undersøgelser med Mersarex eller i programmer for anvendelse af Mersarex med særlig udleveringstilladelse.
The company informed the CHMP that there are no patients currently using Mersarex in clinical trials or compassionate use programmes.
EU/1/19/1383/028 Lacosamide UCB 50/100/ 150 mg
EU/1/19/1383/028 Lacosamide UCB 50 / 100/
1 flaske + 1 målebæger + 1 oral sprøjte + 1 adaptor
1 bottle + 1 measuring cup + 1 oral syringe + 1 adaptor
14 tabletter + 14 tabletter + 14 tabletter + 14 tabletter
Treatment initiation pack: 14 tablets + 14 tablets + 14 tablets + 14 tablets
(enkeltdosis)
Syrup
Filmovertrukket tablet Oral anvendelse Blister (PVC/PVDC/alu)
Film-coated tablet Oral use
EU-nummer Særnavn
MA (EU) number Invented name
Styrke Lægemiddelform
Pharmaceutical form
EMEA/402553/2008
Ref. EMEA/402553/2008
London, den 21. august 2008 Ref. dok.
London, 21 August 2008 Doc.
Internationalt fællesnavn (INN): ketoprofen
International non-proprietary name (INN): ketoprofen
Det primære effektmål var ændringen i smerternes intensitet efter 12 ugers behandling.
The main measure of effectiveness was the change in the severity of pain after 12 weeks of treatment.
Det skulle have været tilgængeligt som gel indeholdende 22,9 mg ketoprofen pr. gram gel.
It was to be available as a gel containing 22.9 mg of ketoprofen per gram of gel.
Spørgsmål og svar i forbindelse med tilbagetrækning af ansøgningen om markedsføringstilladelse for Diractin
Questions and answers on the withdrawal of the marketing application for Diractin
Virkningerne af Diractin er først blevet afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Diractin were first tested in experimental models before being studied in humans.
I undersøgelsen blev tre forskellige doser af medicinen (25 mg, 50 mg og 100 mg to gange om dagen) sammenlignet med placebo (uvirksom behandling).
The study compared the effectiveness of three different doses of Diractin (25 mg, 50 mg and 100 mg twice a day) with that of placebo (a dummy treatment).
CHMP's var betænkelig over, at effektiviteten af Diractin ikke var blevet påvist i tilstrækkelig grad i den eneste hovedundersøgelse: Sammenlignet med placebo reducerede Diractin ikke smerteniveauet i en grad, der ville være relevant for patienterne.
The CHMP was concerned that the effectiveness of Diractin had not been sufficiently demonstrated in the single main study: compared with placebo, Diractin did not reduce pain levels to an extent that would be relevant for patients.
Diractin er et lægemiddel, der indeholder det aktive stof ketoprofen.
Diractin is a medicine that contains the active substance ketoprofen.
Det aktive stof i Diractin, ketoprofen, er et non-steroidt antiinflammatorisk lægemiddel (NSAID).
The active substance in Diractin, ketoprofen, is a non-steroidal anti-inflammatory drug (NSAID).
Effektiviteten af Diractin blev undersøgt i en hovedundersøgelse af i alt 866 patienter med osteoarthritis i knæet.
The effectiveness of Diractin was studied in one main study involving 866 patients with osteoarthritis of the knee.
Hvad er Diractin?
What is Diractin?
Virksomheden har informeret CHMP om, at tilbagetrækningen ingen konsekvenser får for patienter, som nu deltager i kliniske undersøgelser.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials.
Den 23. juli 2008 meddelte IDEA AG officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at man ønsker at tilbagekalde sin ansøgning om markedsføringstilladelse for Diractin til behandling af symptomer på inflammation og smerter i forbindelse med osteoarthritis.
On 23 July 2008, IDEA AG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Diractin, for the treatment of the symptoms of inflammation and pain associated with osteoarthritis.
Hvad forventedes Diractin anvendt til?
What was Diractin expected to be used for?
På tilbagetrækningstidspunktet var det derfor CHMP's opfattelse, at de eventuelle fordele ved Diractin ikke opvejede de påviste risici.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that any benefits of Diractin did not outweigh the identified risks.
Det forventes at virke ved at blokere et enzym kaldet cyclooxygenase, som producerer prostaglandiner, som indgår i inflammationsprocessen.
It is expected to work by blocking an enzyme called cyclo-oxygenase, which produces prostaglandins, substances that are involved in the inflammation process.
Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Diractin eller i programmer for anvendelse af Diractin med særlig udleveringstilladelse?
What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Diractin?
Hvori bestod CHMP's vigtigste betænkeligheder?
What were the main concerns of the CHMP at that time?
Ved at reducere produktionen af prostaglandiner forventes Diractin at reducere den inflammation og smerte, der er forårsaget af osteoarthritis.
By reducing the production of prostaglandins, Diractin is expected to reduce the inflammation and pain caused by osteoarthritis.
Hvordan forventes Diractin at virke?
How is Diractin expected to work?
I Diractingelen er ketoprofen indkapslet i særlige små fedtpartikler (kaldet "transfersomer"), som forventes at transportere ketoprofen gennem huden og frigive det dybt under huden, hvor inflammationen ved osteoarthritis opstår.
In Diractin gel, the ketoprofen is contained in special, small, fatty particles (called ‘Transfersomes') that are expected to carry the ketoprofen through the skin and release it deep below the skin, where the inflammation in osteoarthritis occurs.
Diractin forventedes anvendt til behandling af symptomer på inflammation og smerter i forbindelse med osteoarthritis (en lidelse, der forårsager hævelser og smerter i leddene).
Diractin was expected to be used to treat the symptoms of inflammation and pain associated with osteoarthritis (a condition that causes swelling and pain in the joints).