FrancophonIA/ELRC3.0 huggingface dataset:
English: For practical information about using Rasagiline ratiopharm, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Rasagiline ratiopharm, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Why is Rasagiline ratiopharm approved?
Danish: Hvorfor blev Rasagiline ratiopharm godkendt?
English: There should be at least 14 days between stopping treatment with Rasagiline ratiopharm and starting treatment with another monoamine-oxidase inhibitor or with pethidine.
Danish: Efter ophør af behandlingen med Rasagiline ratiopharm skal der gå mindst 14 dage før påbegyndelse af behandling med andre MAO-hæmmere eller petidin.
English: It must also not be used with pethidine (a painkiller).
Danish: Det må heller ikke anvendes sammen med det smertestillende middel petidin.
English: What are the risks associated with Rasagiline ratiopharm?
Danish: Hvilke risici er der forbundet med Rasagiline ratiopharm?
English: For the full list of all side effects and restrictions with Rasagiline ratiopharm, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Rasagiline ratiopharm fremgår af indlægssedlen.
English: 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).
Danish: 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.
English: For the full list of all side effects reported with Rasagiline ratiopharm, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Rasagiline ratiopharm fremgår af indlægssedlen.
English: How is Rasagiline ratiopharm used?
Danish: Hvordan anvendes Rasagiline ratiopharm?
English: What benefits of Rasagiline ratiopharm have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Rasagiline ratiopharm?
English: How does Rasagiline ratiopharm work?
Danish: Hvordan virker Rasagiline ratiopharm?
English: 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).
Danish: Dette gælder både lægemidler og håndkøbsplantepræparater såsom prikbladet perikum (der anvendes til behandling af depression).
English: This is because the
Danish: Det skyldes, at sammensætningen af
English: Cortacare received a marketing authorisation valid throughout the EU on 27 August 2018.
Danish: Cortacare fik en markedsføringstilladelse med gyldighed i hele EU den 27. august 2018.
English: Further information on Cortacare can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Yderligere information om Cortacare findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: As for every medicine, the company provided studies on the quality of Cortacare.
Danish: Som for alle lægemidler fremlagde virksomheden studier af kvaliteten af Cortacare.
English: Other information about Cortacare
Danish: Andre oplysninger om Cortacare
English: Cortacare is sprayed onto the affected area of skin at a distance of about 10 cm once daily for a week.
Danish: Cortacare sprøjtes på det berørte hudområde fra en afstand af ca. 10 cm én gang dagligt i en uge.
English: An overview of Cortacare and why it is authorised in the EU
Danish: En oversigt over Cortacare, og hvorfor det er godkendt i EU
English: What are the benefits and risks of Cortacare?
Danish: Hvilke fordele og risici er der forbundet med Cortacare?
English: Cortacare (hydrocortisone aceponate)
Danish: Cortacare (hydrocortisonaceponat)
English: 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.
Danish: 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.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Cortacare has been shown to be comparable to Cortavance.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Cortacare kan sammenlignes med Cortavance.
English: This makes the medicine more effective at low doses in skin conditions.
Danish: Dette gør lægemidlet mere effektivt til behandling af hudsygdomme ved lave doser.
English: This reduces swelling, redness and itching.
Danish: Derved reduceres hævelser, rødme og kløe.
English: 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.
Danish: 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.
English: How has Cortacare been studied?
Danish: Hvordan blev Cortacare undersøgt?
English: It contains the active substance hydrocortisone aceponate.
Danish: Det indeholder det aktive stof hydrocortisonaceponat.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: What is Cortacare and what is it used for?
Danish: Hvad er Cortacare, og hvad anvendes det til?
English: For more information about using Cortacare, see the package leaflet or contact your veterinarian or pharmacist.
Danish: For mere information om brug af Cortacare, se indlægssedlen eller kontakt dyrlægen eller apotekspersonalet.
English: Cortacare is a ‘hybrid medicine'.
Danish: Cortacare er et "hybridt lægemiddel".
English: Cortacare is available as a spray and can only be obtained with a prescription.
Danish: Cortacare fås som spray og udleveres kun efter recept.
English: Why is Cortacare authorised in the EU?
Danish: Hvorfor blev Cortacare godkendt i EU?
English: The reference medicine for Cortacare is Cortavance.
Danish: Referencelægemidlet for Cortacare er Cortavance.
English: 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.
Danish: 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.
English: Because Cortacare is a hybrid medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Cortacare er et hybridt lægemiddel, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Cortacare is a corticosteroid veterinary medicine used to treat inflamed and itchy skin conditions in dogs.
Danish: Cortacare er et kortikosteroidholdigt veterinærlægemiddel, der anvendes til at behandle hunde med betændt og kløende hud.
English: 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.
Danish: 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.
English: The precautions are the same as for the reference medicine since Cortacare is a hybrid medicine.
Danish: Disse forholdsregler er de samme som for referencelægemidlet, eftersom Cortacare er et hybridt lægemiddel.
English: 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.
Danish: 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.
English: How is Cortacare used?
Danish: Hvordan anvendes Cortacare?
English: How does Cortacare work?
Danish: Hvordan virker Cortacare?
English: Ref. EMEA/727640/2009 EMEA/H/C/1057
Danish: ref. EMA/727640/2009 EMEA/H/C/1057
English: The main measure of effectiveness was the number of patients who were cured.
Danish: Det primære effektmål var antallet af patienter, som blev helbredt.
English: What is Mersarex?
Danish: Hvad er Mersarex?
English: It contains the active substance iclaprim.
Danish: Det indeholder det aktive stof iclaprim.
English: Questions and answers on the withdrawal of the marketing authorisation application for Mersarex iclaprim
Danish: Spørgsmål og svar vedrørende tilbagetrækningen af ansøgningen om markedsføringstilladelse for Mersarex iclaprim
English: The company presented results from two main studies involving 991 adults with complicated infections of the skin and soft tissues.
Danish: Virksomheden fremlagde resultaterne fra to hovedundersøgelser, der omfattede 991 voksne med komplicerede hud- og bløddelsinfektioner.
English: The effects of Mersarex were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Mersarex blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: Around half of the patients were treated with Mersarex, while the others were treated with linezolid (another antibiotic).
Danish: Omkring halvdelen af patienterne blev behandlet med Mersarex, mens resten blev behandlet med linezolid (et andet antibiotikum).
English: The CHMP also noted that some bacteria already show a level of resistance to the antibiotic even before it is in general use.
Danish: CHMP bemærkede ligeledes, at nogle bakterier allerede har en vis resistens over for antibiotikummet, inden det overhovedet er taget i brug generelt.
English: 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.
Danish: "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.
English: 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.
Danish: 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.
English: The study looked at whether Mersarex given for up to 14 days was as good as linezolid.
Danish: Undersøgelsen tog sigte på at konstatere, om Mersarex givet i op til 14 dage var lige så effektivt som linezolid.
English: Bacteria need this protein to produce the active form of folic acid, which they need to multiply.
Danish: Bakterierne har brug for dette protein til at producere den aktive form af folinsyre, som de skal bruge til at formere sig.
English: The active substance in Mersarex, iclaprim, is an antibiotic of the group ‘dihydrofolate reductase inhibitors'.
Danish: Det aktive stof i Mersarex, iclaprim, er et antibiotikum, som tilhører gruppen af dihydrofolatreduktaseinhibitorer.
English: 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.
Danish: 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.
English: What was Mersarex expected to be used for?
Danish: Hvad forventedes Mersarex anvendt til?
English: 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.
Danish: 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.
English: It was expected to work by blocking the action of a bacterial protein called dihydrofolate reductase.
Danish: Det forventedes at virke ved at hæmme virkningen af et bakterieprotein, der hedder dihydrofolatreduktase.
English: By blocking the action of dihydrofolate reductase, the medicine was expected to slow down the growth and spread of the bacteria.
Danish: Ved at hæmme virkningen af dihydrofolatreduktase forventedes lægemidlet at hæmme bakteriernes vækst og spredning.
English: 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.
Danish: 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.
English: How was Mersarex expected to work?
Danish: Hvordan forventedes Mersarex at virke?
English: Mersarex is a concentrate for solution for infusion (drip into a vein).
Danish: Mersarex er et koncentrat til infusionsvæske, opløsning (drop i en vene).
English: Mersarex was expected to be used to treat complicated infections of the skin and the ‘soft tissues' below the skin.
Danish: Mersarex forventedes anvendt til behandling af infektioner i huden og det underliggende bløde væv.
English: What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Mersarex?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Mersarex eller i programmer for anvendelse af Mersarex med særlig udleveringstilladelse?
English: The company informed the CHMP that there are no patients currently using Mersarex in clinical trials or compassionate use programmes.
Danish: 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.
English: EU/1/19/1383/028 Lacosamide UCB 50 / 100/
Danish: EU/1/19/1383/028 Lacosamide UCB 50/100/ 150 mg
English: 1 bottle + 1 measuring cup + 1 oral syringe + 1 adaptor
Danish: 1 flaske + 1 målebæger + 1 oral sprøjte + 1 adaptor
English: Treatment initiation pack: 14 tablets + 14 tablets + 14 tablets + 14 tablets
Danish: 14 tabletter + 14 tabletter + 14 tabletter + 14 tabletter
English: Syrup
Danish: (enkeltdosis)
English: Film-coated tablet Oral use
Danish: Filmovertrukket tablet Oral anvendelse Blister (PVC/PVDC/alu)
English: MA (EU) number Invented name
Danish: EU-nummer Særnavn
English: Pharmaceutical form
Danish: Styrke Lægemiddelform
English: Ref. EMEA/402553/2008
Danish: EMEA/402553/2008
English: London, 21 August 2008 Doc.
Danish: London, den 21. august 2008 Ref. dok.
English: International non-proprietary name (INN): ketoprofen
Danish: Internationalt fællesnavn (INN): ketoprofen
English: The main measure of effectiveness was the change in the severity of pain after 12 weeks of treatment.
Danish: Det primære effektmål var ændringen i smerternes intensitet efter 12 ugers behandling.
English: It was to be available as a gel containing 22.9 mg of ketoprofen per gram of gel.
Danish: Det skulle have været tilgængeligt som gel indeholdende 22,9 mg ketoprofen pr. gram gel.
English: Questions and answers on the withdrawal of the marketing application for Diractin
Danish: Spørgsmål og svar i forbindelse med tilbagetrækning af ansøgningen om markedsføringstilladelse for Diractin
English: The effects of Diractin were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Diractin er først blevet afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: 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).
Danish: I undersøgelsen blev tre forskellige doser af medicinen (25 mg, 50 mg og 100 mg to gange om dagen) sammenlignet med placebo (uvirksom behandling).
English: 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.
Danish: 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.
English: Diractin is a medicine that contains the active substance ketoprofen.
Danish: Diractin er et lægemiddel, der indeholder det aktive stof ketoprofen.
English: The active substance in Diractin, ketoprofen, is a non-steroidal anti-inflammatory drug (NSAID).
Danish: Det aktive stof i Diractin, ketoprofen, er et non-steroidt antiinflammatorisk lægemiddel (NSAID).
English: The effectiveness of Diractin was studied in one main study involving 866 patients with osteoarthritis of the knee.
Danish: Effektiviteten af Diractin blev undersøgt i en hovedundersøgelse af i alt 866 patienter med osteoarthritis i knæet.
English: What is Diractin?
Danish: Hvad er Diractin?
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials.
Danish: Virksomheden har informeret CHMP om, at tilbagetrækningen ingen konsekvenser får for patienter, som nu deltager i kliniske undersøgelser.
English: 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.
Danish: 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.
English: What was Diractin expected to be used for?
Danish: Hvad forventedes Diractin anvendt til?
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that any benefits of Diractin did not outweigh the identified risks.
Danish: På tilbagetrækningstidspunktet var det derfor CHMP's opfattelse, at de eventuelle fordele ved Diractin ikke opvejede de påviste risici.
English: It is expected to work by blocking an enzyme called cyclo-oxygenase, which produces prostaglandins, substances that are involved in the inflammation process.
Danish: Det forventes at virke ved at blokere et enzym kaldet cyclooxygenase, som producerer prostaglandiner, som indgår i inflammationsprocessen.
English: What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Diractin?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Diractin eller i programmer for anvendelse af Diractin med særlig udleveringstilladelse?
English: What were the main concerns of the CHMP at that time?
Danish: Hvori bestod CHMP's vigtigste betænkeligheder?
English: By reducing the production of prostaglandins, Diractin is expected to reduce the inflammation and pain caused by osteoarthritis.
Danish: Ved at reducere produktionen af prostaglandiner forventes Diractin at reducere den inflammation og smerte, der er forårsaget af osteoarthritis.
English: How is Diractin expected to work?
Danish: Hvordan forventes Diractin at virke?
English: 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.
Danish: 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.
English: 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).
Danish: Diractin forventedes anvendt til behandling af symptomer på inflammation og smerter i forbindelse med osteoarthritis (en lidelse, der forårsager hævelser og smerter i leddene).
English: No compassionate use programmes with Diractin are being conducted.
Danish: Der findes ingen programmer for anvendelse af Diractin med særlig udleveringstilladelse.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Diractin
Danish: 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 Diractin ikke kunne have været godkendt til behandling af symptomer på inflammation og smerter i forbindelse med osteoarthritis.
English: - information about:
Danish: - Information om:
English: Date of first authorisation: 19 February 2009 Date of renewal: 19 February 2014
Danish: Dato for første markedsføringstilladelse: 19. februar 2009 Dato for seneste fornyelse: 19. februar 2014
English: Not known (cannot be estimated from available data)
Danish: - Ikke kendte (kan ikke estimeres ud fra forhåndenværende data):
English: • There is a possibility that new antibodies can form in your body when this medicine is used.
Danish: • Der er mulighed for, at nye antistoffer kan dannes i Deres krop, når dette lægemiddel anvendes.
English: Indeed, there has been a limited exposure due to a recent and limited marketing of the product (launched in the EU only in August 2011 and marketed in only few Member States).
Danish: Der har ganske vist være en begrænset eksponering på grund af en sen og begrænset markedsføring af produktet (først lanceret i EU i august 2011 og kun markedsført i få medlemslande).
English: The clinical significance of these antibodies is not known.
Danish: Den kliniske betydning af disse antistoffer kendes ikke.