FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pramipexole Teva has been shown to have comparable quality and to be bioequivalent to Sifrol.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Pramipexol Teva i overensstemmelse med EU's krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Sifrol.
English: Because Pramipexole Teva is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine (i.e. that the two medicines produce the same levels of the active substance in the body).
Danish: Da Pramipexol Teva er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet (dvs. at de to lægemidler producerer samme mængde af det aktive stof i kroppen).
English: Other information about Pramipexole Teva:
Danish: Andre oplysninger om Pramipexol Teva:
English: The full EPAR for Pramipexole Teva can be found here.
Danish: Den fuldstændige EPAR for Pramipexol Teva findes her.
English: Pramipexole stimulates the brain as dopamine would, so that patients can control their movement and have fewer of the signs and symptoms of Parkinson's disease, such as shaking, stiffness and slowness of movement.
Danish: Pramipexol stimulerer hjernen på samme måde som dopamin, så patienten kan styre sine bevægelser og har færre tegn og symptomer på Parkinsons sygdom som f.eks. rysten, stive og langsomme bevægelser.
English: Therefore, the CHMP's view was that, as for Sifrol, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Sifrol.
English: Pramipexole Teva is used to treat the symptoms of Parkinson's disease, a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
Danish: Pramipexol Teva anvendes til behandling af symptomerne på Parkinsons sygdom, der er en fremadskridende hjernesygdom, som forårsager rysten, langsomme bevægelser og muskelstivhed.
English: Pramipexole Teva is a ‘generic medicine'.
Danish: Pramipexol Teva er et ”generisk lægemiddel”.
English: The European Commission granted a marketing authorisation valid throughout the EU for Pramipexole Teva to Teva Pharma B.V. on 18 December 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Pramipexol Teva til Teva Pharma B.V.
English: Pramipexole Teva is a medicine containing the active substance pramipexole base.
Danish: Pramipexol Teva er et lægemiddel, som indeholder det aktive stof pramipexolbase.
English: What are the benefit and risk of Pramipexole Teva?
Danish: Hvilken fordel og risiko er der forbundet med Pramipexol Teva?
English: Because Pramipexole Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Danish: Da Pramipexol Teva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: The active substance in Pramipexole Teva, pramipexole, is a dopamine agonist, which imitates the action of dopamine.
Danish: Det aktive stof i Pramipexol Teva, pramipexol, er en dopaminagonist, som efterligner virkningen af dopamin.
English: The Committee recommended that Pramipexole Teva be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Pramipexol Teva.
English: Why has Pramipexole Teva been approved?
Danish: Hvorfor blev Pramipexol Teva godkendt?
English: How has Pramipexole Teva been studied?
Danish: Hvordan blev Pramipexol Teva undersøgt?
English: How is Pramipexole Teva used?
Danish: Hvordan anvendes Pramipexol Teva?
English: What is Pramipexole Teva used for?
Danish: Hvad anvendes Pramipexol Teva til?
English: What is Pramipexole Teva?
Danish: Hvad er Pramipexol Teva?
English: How does Pramipexole Teva work?
Danish: Hvordan virker Pramipexol Teva?
English: *Inhalation Kit:
Danish: *Inhalationssæt:
English: 6 spare Insulin Release Units (IRUs)
Danish: 1 insulininhalator 1 reservekammer 6 ekstra insulinfrigivelsesenheder
English: Efficib is taken twice a day.
Danish: Efficib tages to gange dagligt.
English: The European Commission granted a marketing authorisation valid throughout the EU for Efficib on 16 July 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Efficib den 16. juli 2008.
English: Other information about Efficib
Danish: Andre oplysninger om Efficib
English: This is a summary of the European public assessment report (EPAR) for Efficib.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Efficib.
English: It is used in addition to diet and exercise in the following ways:
Danish: Det anvendes sammen diæt og motion på følgende måder:
English: The full EPAR for Efficib can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Efficib findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The results of three further studies were used to support the use of Efficib.
Danish: Der blev fremlagt resultater af tre yderligere undersøgelser til støtte for anvendelsen af Efficib.
English: The company also carried out additional studies to show that the active substances in Efficib are absorbed by the body in the same way as the two medicines given separately.
Danish: Virksomheden gennemførte desuden yderligere undersøgelser for at vise, at det aktive stof i Efficib optages i kroppen på samme måde som de to lægemidler givet hver for sig.
English: 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 Efficib.
Danish: 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 Efficib.
English: Efficib was more effective than metformin alone.
Danish: Efficib var mere effektivt end metformin alene.
English: The most common side effect with Efficib (seen in between 1 and 10 patients in 100) is nausea (feeling sick).
Danish: Den hyppigste bivirkning ved Efficib (som optræder hos mellem 1 og 10 patienter ud af 100) er kvalme.
English: The company presented the results of three studies of Januvia/Xelevia to support the use of Efficib in patients who were not satisfactorily controlled on their existing metformin treatment.
Danish: Virksomheden fremlagde resultaterne af tre undersøgelser af Januvia/Xelevia til støtte for brugen af Efficib til patienter, som ikke kunne kontrolleres tilfredsstillende med den nuværende metforminbehandling.
English: For more information about treatment with Efficib, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Efficib, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The CHMP decided that Efficib's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Efficib opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: Efficib sitagliptin / metformin hydrochloride
Danish: Efficib sitagliptin/metforminhydrochlorid
English: Efficib should be taken with food to avoid any stomach problems caused by metformin.
Danish: Efficib skal indtages sammen med mad for at undgå maveproblemer forårsaget af metformin.
English: In the first of the three further studies, Efficib was more effective than metformin or sitagliptin alone.
Danish: I den første af tre yderligere undersøgelser var Efficib mere effektivt end metformin eller sitagliptin alene.
English: What is the risk associated with Efficib?
Danish: Hvilken risiko er der forbundet med Efficib?
English: Efficib is a medicine that contains two active substances, sitagliptin and metformin hydrochloride.
Danish: Efficib er et lægemiddel, der indeholder de to aktive stoffer sitagliptin og metforminhydrochlorid.
English: It must not be used in patients who have diabetic ketoacidosis or pre coma (dangerous conditions that can occur in diabetes), problems with the kidneys or liver, conditions that may affect the kidneys, or a disease that causes a reduced supply of oxygen to the tissues such as failure of the heart or lungs or a recent heart attack.
Danish: Det må ikke anvendes til patienter, som har diabetisk ketoacidose eller prækoma (alvorlig tilstand, der kan opstå hos sukkersygepatienter), nyre- eller leverproblemer, sygdomme, som kan påvirke nyrerne, eller en sygdom, som medfører dårlig iltforsyning til vævene, såsom hjerte- eller lungeinsufficiens eller et nyligt hjerteanfald.
English: If Efficib is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered, to avoid hypoglycaemia (low blood sugar levels).
Danish: Hvis Efficib tages sammen med et sulfonylurinstof eller insulin, skal dosen af sulfonylurinstof eller insulin muligvis sænkes for at undgå hypoglykæmi (lavt blodsukkerniveau).
English: The active substances in Efficib, sitagliptin and metformin hydrochloride, each have a different mode of action.
Danish: De aktive stoffer i Efficib, sitagliptin og metforminhydrochlorid, virker hver især forskelligt.
English: Efficib is used in patients with type 2 diabetes to improve the control of blood glucose (sugar) levels.
Danish: Efficib anvendes til patienter med type 2-diabetes til at forbedre reguleringen af blodglukoseniveauet (blodsukkerniveauet).
English: Efficib must not be used in people who are hypersensitive (allergic) to sitagliptin, metformin or any of the other ingredients.
Danish: Efficib må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for sitagliptin, metformin eller andre af indholdsstofferne.
English: Why has Efficib been approved?
Danish: Hvorfor er Efficib blevet godkendt?
English: The first included 1,091 patients who were not satisfactorily controlled on diet and exercise alone and compared the effect of Efficib with that of metformin or sitagliptin alone.
Danish: Den første undersøgelse omfattede 1 091 patienter, som ikke kunne kontrolleres tilstrækkeligt med diæt og motion alene, og sammenlignede virkningen af Efficib med virkningen af metformin eller sitagliptin alene.
English: For the full list of all side effects reported with Efficib, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Efficib fremgår af indlægssedlen.
English: How has Efficib been studied?
Danish: Hvordan er Efficib blevet undersøgt?
English: What benefit has Efficib shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Efficib?
English: What is Efficib?
Danish: Hvad er Efficib?
English: What is Efficib used for?
Danish: Hvad anvendes Efficib til?
English: How does Efficib work?
Danish: Hvordan virker Efficib?
English: How is Efficib used?
Danish: Hvordan anvendes Efficib?
English: Octegra was initially approved in June 1999.
Danish: Octegra blev godkendt første gang i juni 1999.
English: Via M. Civitali, 1 20148 Milano Italy
Danish: Via M. CIVItali, 1 20148 Milano Italien
English: 4745-457 S. Mamede do Coronado
Danish: 4745-457 S. Mamede do Coronado Portugal
English: - The Committee considered the Referral made under Article 6(12) of Commission Regulation (EC) No 1084/2003, for Octegra and associated names (See Annex 1).
Danish: - Udvalget behandlede sagen, der var indbragt i henhold til artikel 6, stk. 12, i Kommissionens forordning (EF) nr. 1084/2003, for Octegra og tilknyttede navne (se bilag I).
English: 190 09 Pikermi- Attica- Athens Greece
Danish: 190 09 Pikermi- Attica- Aten
English: This procedure is a referral following a Mutual Recognition Procedure concerning the above variation application which was submitted for Octegra film-coated tablets to Germany as Reference Member State (RMS) and the Concerned Member States (CMS) AT, BE, EL, ES, FR, IT, LU, NL and PT on 5 December 2006.
Danish: Denne procedure er en indbringelsesprocedure efter en gensidig anerkendelsesprocedure vedrørende ovennævnte ansøgning om ændring, som blev indgivet for Octegra filmovertrukne tabletter den 5. december 2006 til Tyskland som referencemedlemsstat og de berørte medlemsstater AT, BE, EL, ES, FR, IT, LU, NL og PT.
English: Octegra film-coated tablets contain 400 mg moxifloxacin as hydrochloride.
Danish: Octegra filmovertrukne tabletter indeholder 400 mg moxifloxacin som hydrochlorid.
English: Procter and Gamble Pharmaceuticals Iberia, SL WTC Almeda park, edificio 1, 2º planta
Danish: Procter and Gamble Pharmaceuticals Iberia, SL WTC Almeda park, edificio 1, 2º planta Cornellá de Llobregat - Barcelona Spanien
English: LU- Luxembourg Therabel Pharma 110 Rue Egide Van Ochem B 1180 Bruxelles
Danish: LU - Luxemburg Therabel Pharma 110 Rue Egide Van Ochem B 1180 Bryssel
English: PROFLOX 400 MG
Danish: PROFLOX 400 mg 400 mg
English: The MRP variation application DE/H/156/01/II/34 concerned an extension of the indication to include the treatment of mild to moderate pelvic inflammatory disease (PID), i.e. infections of upper genital tract, including salpingitis and endometritis.
Danish: Ansøgningen om ændring under proceduren for gensidig anerkendelse DE/H/156/01/II/34 vedrørte en udvidelse af indikationen til at omfatte let til moderat PID (pelvic inflammatory disease), dvs. infektioner i de øvre genitaler, herunder salpingitis og endometritis.
English: Objections and concerns over the efficacy and safety of Octegra in the proposed indication were raised during the Mutual Recognition variation procedure.
Danish: I løbet af den gensidige anerkendelsesprocedure vedrørende ændringen blev der rejst indsigelser og betænkeligheder vedrørende effekten og sikkerheden ved Octegra i forbindelse med den ansøgte indikation.
English: Film-coated tablet
Danish: Filmovertrukne tabletter Oral anvendelse
English: - The Committee considered that robust data is available showing the efficacy of Octegra in the indication “Treatment of mild to moderate pelvic inflammatory disease (PID), i.e. infections of upper genital tract, including salpingitis and endometritis” , however due to emerging resistance of N. gonorrhoeae, moxifloxacin should not be used in empirical monotherapy, unless moxifloxacinresistant N. gonorrhoeae can be excluded.
Danish: - Udvalget var af den opfattelse, at der eksisterer fyldestgørende data for virkningen af Octegra i forbindelse med indikationen "Behandling af let til moderat PID (pelvic inflammatory disease), dvs. infektioner i de øvre genitaler, herunder salpingitis og endometritis", dog må moxifloxacin på grund af fremkomsten af resistens over for N. gonorrhoeae ikke anvendes i empirisk monoterapi, medmindre moxifloxacin-resistent N. gonorrhoeae kan udelukkes.
English: OCTEGRA 400 mg, comprimé pelliculé
Danish: OCTEGRA 400 mg, compromé pelliculé
English: - The Committee, in view of the presented data on efficacy and safety, considered that the Benefit / Risk balance for Octegra and associated names in the “ The treatment of mild to moderate pelvic inflammatory disease (PID), i.e. infections of upper genital tract, including salpingitis and endometritis” with the restrictions concerning empirical monotherapy was favourable; - The CHMP, as a consequence, recommended the amendment of the Summary of Product Characteristics sections 4.1, 4.2, 4.3, 4.4, 5.1 and 5.2 and Package Leaflet relevant sections as set out in Annex III for Octegra and associated names (see Annex I).
Danish: - CHMP anbefalede derfor, at der for Octegra og tilknyttede navne (se bilag I) foretages ændring af afsnit 4.1, 4.2, 4.3, 4.4, 5.1 og 5.2 i produktresuméet samt relevante afsnit af indlægssedlen som beskrevet i bilag III.
English: BE - Belgium THERABEL PHARMA S.A. Rue Egide Van Ophem 108
Danish: THERABEL PHARMA S.A. Rue Egide Van Ophem 108 1180 BRYSSEL Belgien
English: Spain
Danish: Grækenland
English: ELPEN A.E. Pharmaceutical Industry
Danish: EL - Grækenland ELPEN A.E. Pharmaceutical Industry 95 Marathonos Av.
English: Octegra 400 mg tabletten
Danish: OCTEGRA 400 mg
English: Box 56
Danish: BILAG I
English: Cattle, cats, dogs
Danish: Kvæg, katte, hunde
English: Intramuscular or intravenous
Danish: Intramuskulær eller intravenøs
English: These veterinary medicinal products are also authorised for use in dogs and cats, but considering the scope of the referral, these target species were not assessed during this procedure.
Danish: Disse veterinærlægemidler er også godkendt til anvendelse i hunde og katte, men i betragtning af formålet med denne procedure, blev disse målarter ikke vurderet.
English: However, the efficacy assessment does not fall within the scope of this referral procedure.
Danish: Dog falder effektivitetsvurderingen ikke ind under formålet med denne procedure for indbringelse af sager.
English: Solupred 125 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung
Danish: Solupred 125 mg Pulver und Lösungsmittel zur Herstellung einer
English: The residue depletion data do not allow a statistically based determination of a withdrawal period.
Danish: Restkoncentrationsdataene giver ikke mulighed for en statistisk baseret tilbageholdelsesperiode.
English: However, the first time point all data were below the MRL was day 21.
Danish: Dog var det første tidspunkt, hvor alle data lå under MRL, dag 21.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, routes of administration, applicant/marketing authorisation holder in the Member States
Danish: Liste over veterinærlægemidlernes navne, lægemiddelformer, styrker, måldyrearter, administrationsveje og ansøger/indehaver af markedsføringstilladelse i medlemsstaterne
English: Twenty-one days after administration residues at injection sites were below the LOQ in all animals.
Danish: 21 dage efter administrationen var restkoncentrationen på injektionsstedet under LOQ i alle dyr.
English: Residues in muscle, liver, kidney and fat were already below LOQ (10 µg/kg) at the earliest slaughter time (day 7).
Danish: Restkoncentrationer i muskel, lever, nyre og fedt var allerede under LOQ (10 µg/kg) på det tidligste slagtetidspunkt (dag 7).
English: Overall summary of the scientific evaluation of veterinary medicinal products containing methylprednisolone hydrogen succinate for use in target species cattle (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af veterinærlægemidler indeholdende methylprednisolonhydrogensuccinat til anvendelse på målarten kvæg (se bilag I)
English: In addition, the pharmacological ADI was exceeded up to 262 fold at day 7 and up to 2.8 fold at day 14.
Danish: I tillæg hertil var det farmakologisk acceptable daglige indtag overskredet op til 262 gange på dag 7 og op til 2,8 gange på dag 14.
English: The residue depletion data concerning methylprednisolone can be summarised as follows:
Danish: Restkoncentrationsdata for methylprednisolon kan sammenfattes som følger:
English: Therefore, on 2 May 2016, Germany initiated a procedure under Article 35 of Directive 2001/82/EC, for veterinary medicinal products containing methylprednisolone hydrogen succinate presented as solutions for injection for intramuscular use in cattle.
Danish: Den 2. maj 2016 indledte Tyskland derfor en procedure i medfør af artikel 35 i direktiv 2001/82/EF for veterinærlægemidler indeholdende methylprednisolonhydrogensuccinat i form af injektionsvæske, opløsning, til intramuskulær anvendelse på kvæg.
English: • After administration of 400 µg/kg bw for 5 consecutive days, residues in injection site muscle ranged from below LOQ (10 µg/kg) to 8393 µg/kg at day 7 after injection and at day 14 from below LOQ to 90 µg/kg.
Danish: • Efter administration of 400 µg/kg kropsvægt i 5 på hinanden følgende dage lå restkoncentrationerne i injektionsstedets muskel i et interval, der gik fra under kvantificeringsgrænsen, LOQ, (10 µg/kg) til 8 393 µg/kg på dag 7 efter injektionen, og på dag 14 fra under LOQ til 90 µg/kg.
English: Methylprednisolone, a 6α-methyl derivative of prednisolone, is a synthetic corticosteroid, which is used in veterinary medicine as a free alcohol, and as various esters.
Danish: Methylprednisolon, et 6α-methylderivat af prednisolon, er et syntetisk kortikosteroid, der anvendes i veterinærlægemidler som en fri alkohol og som forskellige estere.
English: Veterinary medicinal products containing methylprednisolone hydrogen succinate are used for treatment of inflammatory or allergic conditions and also for treatment and prevention of shock conditions.
Danish: Veterinærlægemidler indeholdende methylprednisolonhydrogensuccinat anvendes til behandling af betændelses- eller allergiske tilstande og til behandling og forebyggelse af choktilstande.
English: Taking all the information together, it cannot be confirmed from the available data that the withdrawal period of 6 days for cattle (meat and offal) for the reference product Solu-Medrol is safe for the consumer.
Danish: Ved at sammenholde alle oplysninger kan det ikke fra de tilgængelige data bekræftes, at en tilbageholdelsesperiode på 6 dage for kvæg (kød og indmad) for referenceproduktet Solu-medrol er sikkert for forbrugeren.
English: No information has been found in open databases (e.g. PubMed, Scopus, VetMed Resource, Web of Science) regarding pharmacokinetic and residue data of methylprednisolone hydrogen succinate in edible tissues and at the injection site of cattle.
Danish: Ingen oplysninger er fundet i åbne databaser (f.eks. PubMed, Scopus, VetMed Resource, Web of Science) angående pharmakokinetiske data og restkoncentrationsdata for methylprednisolonhydrogensuccinat i spiseligt væv og på injektionsstedet på kvæg.
English: All references to target species cattle should be deleted from the summary of product characteristics, labelling and package leaflet.
Danish: Alle referencer til målarten kvæg skal slettes fra produktresuméet, etiketteringen og indlægssedlen.
English: This is relevant for administration of the products via the intramuscular route as well as administration via the intravenous route.
Danish: Dette er relevant for administration af produktet via de intramuskulære og intravenøse administrationsveje.
English: The only residue depletion study for methylprednisolone after intramuscular injection in cattle is cited in the CVMP EPMAR for methylprednisolone (EMEA/MRL/798/01-FINAL).
Danish: Den eneste restkoncentrationsundersøgelse for methylprednisolon efter intramuskulær injektion i kvæg er citeret i CVMP's EPMAR for methylprednisolon (EMEA/MRL/798/01-FINAL).
English: At the injection site, the MRL for muscle was exceeded more than 800 fold at day 7 and still 9 fold at day 14.
Danish: På injektionsstedet var maksimalgrænseværdien for restkoncentrationen (MRL) i musklen overskredet mere end 800 gange på dag 7 og stadig 9 gange på dag 14.