FrancophonIA/ELRC3.0 huggingface dataset:
English: With regard to side effects, the medicine may cause respiratory depression, as is the case with other comparable medicines, but is generally well tolerated.
Danish: Hvad angår bivirkninger kan lægemidlet give vejrtrækningsproblemer, som det er tilfældet ved andre lignende lægemidler, men det tåles generelt godt.
English: Buccolam is used to stop prolonged, acute (sudden) convulsive seizures in children and adolescents (from 3 months to less than 18 years of age).
Danish: Buccolam anvendes til at stoppe langvarige, akutte (pludselige) krampeanfald hos børn og unge (fra 3 måneder og op til 18 år).
English: For more information about treatment with Buccolam, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Buccolam, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: When given by carers or parents Buccolam should only be used when the child has already been diagnosed with epilepsy.
Danish: Når Buccolam gives af plejepersoner eller forældre, må lægemidlet kun anvendes, når barnet allerede har fået stillet diagnosen epilepsi.
English: If the seizure has not stopped within 10 minutes of giving Buccolam, they should seek medical help immediately.
Danish: Hvis anfaldet ikke er ophørt, inden for 10 minutter efter at man har givet Buccolam, skal man straks søge læge.
English: Buccolam has the advantage of being quicker and easier to administer than rectal or intravenous medicines.
Danish: Buccolam har den fordel, at det er hurtigere og nemmere at give end rektale eller intravenøse lægemidler.
English: Convulsions are caused by excessive electrical activity in the brain.
Danish: Kramper skyldes for stor elektrisk aktivitet i hjernen.
English: Buccolam is a medicine that contains the active substance midazolam.
Danish: Buccolam er et lægemiddel, der indeholder det aktive stof midazolam.
English: Based on the results of the studies presented, the CHMP concluded that Buccolam is at least as effective as existing treatments for stopping acute prolonged, convulsive seizures in children.
Danish: På baggrund af de forelagte undersøgelser konkluderede CHMP, at Buccolam er mindst lige så effektivt som de eksisterende behandlinger til at stoppe akutte, langvarige krampeanfald hos børn.
English: In infants from 3 months to less than 6 months Buccolam should only be used within a hospital and where equipment is available for resuscitation and monitoring of the patient due to an increased risk respiratory depression (inhibition of breathing).
Danish: Hos spædbørn fra 3 til 6 måneder må Buccolam kun anvendes på et hospital, og hvor der er adgang til udstyr til genoplivning og overvågning af patienten, på grund af øget risiko for respirationsdepression (vejrtrækningsproblemer).
English: Although intravenous medicines may take less time to start working once injected, it takes time to gain access to the veins, especially in children.
Danish: Selvom intravenøse lægemidler hurtigere begynder at virke, når først de er injiceret, tager det tid at få adgang til blodårer, særligt hos børn.
English: The full amount of the appropriate prefilled syringe should be given slowly into the space between the gum and the cheek.
Danish: Hele indholdet af den fyldte sprøjte skal gives langsomt i hulrummet mellem gummerne og kinden.
English: In the four studies, oromucosal midazolam was effective in stopping a seizure within 10 minutes in 65 to 78% of children compared with 41 to 85% of children who received rectal diazepam.
Danish: I de fire undersøgelser var midazolam indgivet via mundhulen effektivt til at stoppe et anfald inden for 10 minutter hos 65-78 % af børnene sammenlignet med 4185 % af de børn, som fik diazepam rektalt.
English: It must not be used in patients with myasthenia gravis (a disease causing muscle weakness), severe respiratory insufficiency (lung conditions that cause difficulty breathing), sleep apnoea syndrome (frequent interruption of breathing during sleep) or severe liver problems.
Danish: Det må ikke anvendes til patienter med myastenia gravis (en sygdom, som forårsager muskelsvækkelse), alvorligt nedsat vejrtrækning (lungesygdomme, som giver vejrtrækningsbesvær), søvnapnøsyndrom (hyppig afbrydelse af vejrtrækning under søvn) eller svære leverproblemer.
English: What is the risk associated with Buccolam?
Danish: Hvilken risiko er der forbundet med Buccolam?
English: Buccolam must not be used in people who may be hypersensitive (allergic) to midazolam, benzodiazepines or any of the other ingredients.
Danish: Buccolam må ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for midazolam, benzodiazepiner eller andre af indholdsstofferne.
English: The Committee therefore decided that Buccolam's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede derfor, at fordelene ved Buccolam opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Buccolam.
English: Reports from the published literature confirmed that oromucosal midazolam is effective in stopping seizures in children.
Danish: Rapporter fra den publicerede litteratur har bekræftet, at midazolam indgivet via mundhulen er effektivt til at stoppe krampeanfald hos børn.
English: The active substance in Buccolam is midazolam, a benzodiazepine, which acts as an anti-convulsant medicine.
Danish: Det aktive stof i Buccolam er midazolam, et benzodiazepin, som virker som et krampestillende lægemiddel.
English: By activating its receptors, Buccolam increases GABA's effects, which will stop a convulsion.
Danish: Ved at aktivere receptorerne øger Buccolam GABA's virkning og stopper derved krampen.
English: Why has Buccolam been approved?
Danish: Hvorfor blev Buccolam godkendt?
English: These studies looked at children with acute convulsions and compared the effects of oromucosal midazolam with those of diazepam (another benzodiazepine) when given intravenously (into a vein) or rectally (into the rectum).
Danish: Disse undersøgelser omhandlede børn med akutte kramper og sammenlignede effekten af midazolam indgivet via mundhulen og diazepam (et andet benzodiazepin) givet intravenøst (i en blodåre) eller rektalt (i endetarmen).
English: The most common side effects with Buccolam (seen in more than 1 patient in 10) are sedation, somnolence (sleepiness), depressed levels of consciousness, respiratory depression and nausea (feeling sick) and vomiting.
Danish: De hyppigste bivirkninger ved Buccolam (som optræder hos flere end 1 ud af 10 patienter) er sløvhed, søvnighed, nedsat bevidsthed, vejrtrækningsproblemer samt kvalme og opkastning.
English: When comparing buccal midazolam with intravenous diazepam, the results were also very similar.
Danish: Når midazolam indgivet via mundhulen blev sammenlignet med diazepam givet intravenøst, var resultaterne også nogenlunde de samme.
English: For the full list of all side effects reported with Buccolam, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Buccolam fremgår af indlægssedlen.
English: It is available as ‘oromucosal solution' (a solution given in the side of the mouth, into the space between the gum and the cheek) in prefilled syringes.
Danish: Det fås som en ”mundhulevæske, opløsning” (en opløsning, som gives i siden af munden i hulrummet mellem gummerne og kinden) i fyldte sprøjter.
English: The fifth study compared buccal midazolam with intravenous diazepam, where the measure of effectiveness was the treatment's ability to stop the seizure within 5 minutes.
Danish: Den femte undersøgelse sammenlignede midazolam indgivet via mundhulen med diazepam indgivet intravenøst, hvor effektmålet var behandlingens evne til at stoppe anfaldet inden for 5 minutter.
English: What is Buccolam?
Danish: Hvad er Buccolam?
English: Neurotransmitters such as GABA are chemicals that allow nerve cells to communicate with each other.
Danish: Buccolam binder sig til neurotransmitteren GABA's receptorer i hjernen og aktiverer dem. Neurotransmittere som GABA er kemikalier, som sætter nervecellerne i stand til at kommunikere med hinanden.
English: In four of these studies, oromucosal midazolam was compared with rectal diazepam and the measure of effectiveness was the treatment's ability to stop the seizure within 10 minutes.
Danish: I fire af disse undersøgelser blev midazolam indgivet via mundhulen sammenlignet med diazepam indgivet rektalt, og effektmålet var behandlingens evne til at stoppe anfaldet inden for 10 minutter.
English: What is Buccolam used for?
Danish: Hvad anvendes Buccolam til?
English: How has Buccolam been studied?
Danish: Hvordan blev Buccolam undersøgt?
English: What benefit has Buccolam shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Buccolam?
English: How is Buccolam used?
Danish: Hvordan anvendes Buccolam?
English: How does Buccolam work?
Danish: Hvordan virker Buccolam?
English: l t o r
Danish: Paknings-størrelse r l
English: Strength Pharmaceutical Form
Danish: (Sær)navn Styrke Lægemiddelform Administration Indre emballage Pakningsstørrelser
English: The studies looked at measurements of pain and disease activity after 13 weeks of treatment.
Danish: Undersøgelserne omfattede målinger af smerte og sygdomsaktivitet efter 13 ugers behandling.
English: What is Joicela?
Danish: Hvad er Joicela?
English: The effects of Joicela were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Joicela blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: Two of the studies involved 3,235 patients with knee osteoarthritis while the third study involved 1,262 patients with hip osteoarthritis.
Danish: To af undersøgelserne omfattede 3.235 patienter med osteoarthritis i knæ, mens den tredje undersøgelse omfattede 1.262 patienter med osteoarthritis i hofter.
English: The Committee was not convinced that screening patients for the DQA1*0102 gene variant sufficiently reduced this risk.
Danish: Udvalget var ikke overbevist om, at en screening af patienterne for genvarianten DQA1*0102 reducerede denne risiko tilstrækkeligt.
English: It was to be available as filmcoated tablets.
Danish: Det var meningen, at det skulle kunne fås som overtrukne tabletter.
English: Withdrawal of the marketing authorisation application for Joicela (lumiracoxib) EMA/917506/2011
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Joicela (lumiracoxib) EMA/917509/2011
English: Joicela is a medicine that contains the active substance lumiracoxib.
Danish: Joicela er et lægemiddel, der indeholder det aktive stof lumiracoxib.
English: Withdrawal of the marketing authorisation application for Joicela (lumiracoxib)
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Joicela (lumiracoxib)
English: What was Joicela expected to be used for?
Danish: Hvad forventedes Joicela anvendt til?
English: How is Joicela expected to work?
Danish: Hvordan forventes Joicela at virke?
English: It blocks the COX-2 enzyme, resulting in a reduction in the production of prostaglandins, substances that are involved in the inflammation process.
Danish: Det blokerer COX-2enzymet, hvilket resulterer i, at produktionen af prostaglandiner, der indgår i betændelsesprocessen, reduceres.
English: DQA1*0102 is thought to increase the risk of liver toxicity in patients taking Joicela.
Danish: DQA1*0102 menes at øge risikoen for levertoksicitet hos patienter, som tager Joicela.
English: Joicela was compared with celecoxib (another medicine used in osteoarthritis) and placebo (a dummy treatment) in three main studies.
Danish: Joicela blev sammenlignet med celecoxib (et andet lægemiddel til behandling af osteoarthritis) og placebo (en virkningsløs behandling) i tre hovedundersøgelser.
English: By reducing the production of prostaglandins, Joicela helps to reduce the symptoms of inflammation, such as pain, seen in osteoarthritis.
Danish: Ved at reducere produktionen af prostaglandiner er Joicela med til at reducere de symptomer på inflammation, f.eks. smerte, der optræder ved osteoarthritis.
English: At the time of the withdrawal, the CHMP was of the view that the benefits of Joicela did not outweigh its risks, particularly its risk of liver toxicity.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved Joicela ikke opvejede risiciene, navnlig risikoen for levertoksicitet.
English: The active substance in Joicela, lumiracoxib, is a selective ‘non-steroidal anti-inflammatory drug' (NSAID) that belongs to the group ‘cyclo-oxygenase 2 (COX-2) inhibitors'.
Danish: Det aktive stof i Joicela, lumiracoxib, er et selektivt non-steroidt, antiinflammatorisk lægemiddel (NSAID), der tilhører gruppen cyclooxygenase-2-hæmmere (COX-2-hæmmere).
English: On 15 April 2011, Novartis officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Joicela for the symptomatic relief in the treatment of osteoarthritis of the knee and hip in patients who are not carriers of the DQA1*0102 allele.
Danish: Den 15. april 2011 meddelte Novartis officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Joicela til symptomlindring ved behandling af osteoarthritis i knæ og hofter hos patienter, som ikke er bærere af allelen DQA1*0102.
English: Based on the review of the data and the company's response to the CHMP's lists of questions, the CHMP had some concerns and was of the provisional opinion that Joicela could not have been approved for the symptomatic treatment of osteoarthritis (swelling and pain in the joints) of the knee and hip in adults who are not carriers of DQA1*0102.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's lister med spørgsmål havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Joicela ikke kunne være blevet godkendt til symptomatisk behandling af osteoarthritis (hævelser og smerter i leddene) i knæ og hofter hos voksne, der ikke er bærere af DQA1*0102.
English: The company informed the CHMP that no clinical trials or compassionate use programmes are currently on-going with Joicela.
Danish: Virksomheden har informeret CHMP om, at der ikke er nogen igangværende kliniske undersøgelser med Joicela eller programmer for anvendelse af Joicela med særlig udleveringstilladelse.
English: Joicela was expected to be used to relieve the symptoms of osteoarthritis (swelling and pain in the joints) of the knee and hip in adults who are not carriers of a gene variant called ‘DQA1*0102'.
Danish: Joicela forventedes anvendt til lindring af tegn og symptomer på osteoarthritis (hævelser og smerter i leddene) i knæ og hofter hos voksne, som ikke er bærere af en genvariant kaldet DQA1*0102.
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Joicela eller i programmer for anvendelse af Joicela med særlig udleveringstilladelse?
English: 27 January 2010
Danish: 27 januar 2010
English: Background information
Danish: BAGGRUNDSOPLYSNINGER
English: Committee for Medicinal Products for Veterinary Use (CVMP)
Danish: Udvalget for veterinærlægemidler (CVMP)
English: The final opinion was converted into a Decision by the European Commission on 27 January 2010.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 27. januar
English: The Committee appointed Dr Anna-Maria Brady as rapporteur and Dr Frédéric Descamps as co-rapporteur.
Danish: Udvalget udpegede dr. Anna-Maria Brady som rapportør og dr. Frédéric Descamps som medrapportør.
English: The application was submitted in the framework of Article 32 of Directive 2001/82/EC, as amended, where the Reference Member State was Slovakia and the Concerned Member States were Poland and Spain.
Danish: Ansøgningen blev indgivet i henhold til artikel 32 i direktiv 2001/82/EF, med senere ændringer, hvor referencemedlemsstaten var Slovakiet, og de berørte medlemsstater var Polen og Spanien.
English: APPM Respipharm is a multi-component formaldehyde inactivated whole-cell bacterial vaccine containing three strains of Actinobacillus pleuropneumoniae (Serotypes 2, 9 and 11) and one strain of Pasteurella multocida (Serotype A).
Danish: APPM Respipharm er en multikomponent formaldehyd-inaktiveret helcelle-bakterievaccine, der indeholder tre stammer af Actinobacillus pleuropneumoniae (serotype 2, 9 og 11) og en stamme af Pasteurella multocida (serotype A).
English: The Mutual Recognition Procedure started on 3 April 2008.
Danish: Den gensidige anerkendelsesprocedure blev indledt den 3. april 2008.
English: Written explanations were provided by the Marketing Authorisation Holder on 14 January 2009 and supplementary information was submitted on 22 April 2009.
Danish: Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 14. januar 2009, og der blev fremsendt supplerende oplysninger den 22. april 2009.
English: Due to concerns raised by Spain during the Mutual Recognition Procedure that APPM Respipharm may pose a potentially serious risk to human or animal health or to the environment with respect to quality and efficacy of the product, the Reference Member State, Slovakia, referred the matter to the Agency on 7 October 2008 under Article 33(4) of Directive 2001/82/EC.
Danish: På grund af Spaniens betænkeligheder under den gensidige anerkendelsesprocedure med hensyn til, hvorvidt APPM Respipharm kan udgøre en potentiel alvorlig risiko for menneskers og dyrs sundhed eller for miljøet, når det gælder lægemidlets kvalitet og virkning, indbragte referencemedlemsstaten Slovakiet sagen for EMEA den 7. oktober 2008 i henhold til artikel 33, stk. 4, i direktiv 2001/82/EF.
English: Respipharm
Danish: om APPM Respipharm
English: Opinion following an Article 33(4)
Danish: Udtalelse som følge af en sag indbragt i henhold til Artikel 33, stk. 4,
English: During its 15-17 September 2009 meeting, the CVMP appointed Dr Kristina Lehmann as rapporteur and Prof. Tibor Soós as co-rapporteur for the re-examination of the abovementioned opinion.
Danish: På mødet den 15.-17. september 2009 udpegede CVMP dr. Kristina Lehmann som rapportør og prof. Tibor Soós som medrapportør for revurderingen af ovennævnte udtalelse.
English: The Marketing Authorisation Holder, Pharmagal Bio s.r.o., submitted an application via mutual recognition for APPM Respipharm, on the basis of the marketing authorisation granted by Slovakia.
Danish: Indehaveren af markedsføringstilladelsen, Pharmagal Bio s.r.o., indgav en ansøgning om gensidig anerkendelse af APPM Respipharm på grundlag af en markedsføringstilladelse udstedt af Slovakiet.
English: Based on the evaluation of the rapporteur's assessment of the currently available data, the CVMP considered that the application does not satisfy the criteria for authorisation in respect of efficacy.
Danish: På grundlag af evalueringen af rapportørernes vurdering af de aktuelt foreliggende oplysninger vurderede CVMP, at ansøgningen ikke opfylder godkendelseskriterierne med hensyn til virkning.
English: The product is indicated for use in pigs (sows and weaned piglets) from 6 weeks of age, intended to induce active immunisation of sows and piglets against pleuropneumonia caused by Actinobacillus pleuropneumoniae and against secondary infection by Pasteurella multocida.
Danish: Lægemidlet er indiceret til brug hos svin (søer og fravænnede smågrise) fra 6-ugers-alderen og er beregnet til at inducere aktiv immunisering af søer og smågrise over for pleuropneumoni forårsaget af Actinobacillus pleuropneumoniae og over for sekundær infektion med Pasteurella multocida.
English: On 28 July 2009, Pharmagal Bio s.r.o.
Danish: Den 28. juli 2009 meddelte Pharmagal Bio s.r.o.
English: The re-examination procedure started on 15 September 2009.
Danish: Revurderingsproceduren blev indledt den 15. september 2009.
English: notified the Agency of its intention to request the reexamination of the CVMP opinion of 15 July 2009.
Danish: EMEA, at virksomheden ville anmode om en revurdering af CVMP's udtalelse af 15. juli 2009.
English: Therefore, the Committee adopted an opinion on 15 July 2009 recommending the suspension of the existing Marketing Authorisation and the refusal of the granting of the Marketing Authorisations for APPM Respipharm.
Danish: Udvalget vedtog derfor en udtalelse den 15. juli 2009, hvori det anbefalede suspendering af den eksisterende markedsføringstilladelse og afslag på ansøgningen om markedsføringstilladelser for APPM Respipharm.
English: Opinion following an Article 33(4) referral for APPM Respipharm EMA/839689/2009
Danish: Udtalelse som følge af en sag indbragt i henhold til Artikel 33, stk. 4, om APPM Respipharm
English: The detailed grounds for the re-examination were submitted by Pharmagal Bio s.r.o.
Danish: Pharmagal Bio s.r.o.
English: This means that Pioglitazone ratio is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
Danish: Det betyder, at Pioglitazone ratio er identisk med et ‘referencelægemiddel', som allerede er godkendt i Den Europæiske Union (EU) kaldet Actos.
English: The CHMP concluded that, in accordance with EU requirements, Pioglitazone ratio had been shown to have comparable quality and to be bioequivalent to Actos.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Pioglitazone ratio er af sammenlignelig kvalitet og er bioækvivalent med Actos.
English: Pioglitazone ratio, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Danish: Det aktive stof i Pioglitazone ratio, pioglitazon, gør cellerne (fedt, muskel og lever) mere følsomme over for insulin, hvilket betyder, at kroppen bedre udnytter den insulin, den selv danner.
English: On 3 February 2012, ratiopharm GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Pioglitazone ratio, for the treatment of type 2 diabetes.
Danish: Den 3. februar 2012 meddelte ratiopharm GmbH officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse for Pioglitazone ratio til behandling af type 2-diabetes tilbage.
English: Pioglitazone ratio was to be used to treat type 2 diabetes in adults, particularly those who are overweight.
Danish: Pioglitazone ratio skulle have været anvendt til behandling af type 2-diabetes hos voksne, især overvægtige.
English: Pioglitazone ratio was developed as a ‘generic medicine'.
Danish: Pioglitazone ratio blev udviklet som et ‘generisk lægemiddel'.
English: Pioglitazone ratio is a medicine that contains the active substance pioglitazone.
Danish: Pioglitazone ratio er et lægemiddel, der indeholder det aktive stof pioglitazon.
English: Therefore, at the time of the withdrawal, the CHMP had given a positive opinion, recommending that a marketing authorisation be granted for Pioglitazone ratio for the treatment of type 2 diabetes.
Danish: På tidspunktet for tilbagetrækningen havde CHMP derfor afgivet en positiv udtalelse, hvori der anbefaledes udstedelse af markedsføringstilladelse for Pioglitazone ratio til behandling af type 2-diabetes.
English: Pioglitazone ratio was also to be used together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.
Danish: Pioglitazone ratio skulle også have været anvendt sammen med insulin til patienter, som ikke er tilfredsstillende reguleret med insulin alene, og som ikke kan tage metformin.
English: Because Pioglitazone ratio is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Danish: Da Pioglitazone ratio er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Actos.