FrancophonIA/ELRC3.0 huggingface dataset:
English: People who are hypersensitive (allergic) to NSAIDs should avoid contact with Novem.
Danish: Personer, som er hypersensitive (allergiske) over for NSAID'er, bør undgå kontakt med Novem.
English: Appropriate studies have been carried out in various target animals to show that Novem is effective and safe in its approved uses.
Danish: Der er udført hensigtsmæssige undersøgelser hos forskellige målgrupper af dyr med henblik på at påvise, at Novem er effektivt og sikkert til de godkendte anvendelser.
English: The withdrawal period for meat is five days.
Danish: Tilbageholdelsestiden for kød er fem dage.
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat or milk used for human consumption.
Danish: Tilbageholdelsestiden er den tid, der skal gå efter administration af et lægemiddel, før et dyr kan slagtes, og kødet eller mælken kan anvendes til menneskeligt konsum.
English: Novem is an anti-inflammatory medicine used in cattle and pigs.
Danish: Novem er et antiinflammatorisk lægemiddel, der anvendes til kvæg og svin.
English: Injections are given under the skin for cattle and into the muscles for pigs.
Danish: Injektionerne gives under huden til kvæg og i musklerne til svin.
English: The withdrawal period is 15 days for meat and five days for milk.
Danish: Tilbageholdelsestiden er 15 dage for kød og fem dage for mælk.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Novem's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Novem opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: As prostaglandins are substances that trigger inflammation, pain, exudation (fluid that leaks out of blood vessels during an inflammation) and fever, meloxicam reduces these signs of disease.
Danish: Da prostaglandiner er stoffer, der udløser betændelse, smerter, væskeudskillelse (væske, der siver ud af blodkarrene under en betændelse) og feber, mindsker meloxicam disse sygdomstegn.
English: The dose to use depends on the animal and its bodyweight.
Danish: Dosis afhænger af dyret og dyrets kropsvægt.
English: Novem contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Danish: Novem indeholder meloxicam, som tilhører en lægemiddelgruppe, der kaldes ikkesteroide antiinflammatoriske lægemidler (NSAID'er).
English: In very rare cases anaphylactoid (allergic) reactions which may be serious (including fatal) may occur and should be treated symptomatically.
Danish: Der kan i meget sjældne tilfælde forekomme anafylaktiske (allergiske) reaktioner, som kan være alvorlige (herunder dødelige).
English: If the product is accidentally self-injected, the advice of a doctor should be sought immediately.
Danish: I tilfælde af utilsigtet selvinjektion bør der straks søges lægehjælp.
English: Meloxicam acts by blocking an enzyme called cyclooxygenase which is involved in the production of prostaglandins.
Danish: Meloxicam virker ved at blokere et enzym kaldet cyclooxygenase, der medvirker ved dannelsen af prostaglandiner.
English: The studies showed that the addition of Novem to antibiotic therapy significantly improved clinical parameters and reduced fever compared to antibiotics alone.
Danish: Undersøgelserne viste, at antibiotika kombineret med Novem forbedrede de kliniske parametre væsentligt og havde en bedre febernedsættende virkning end antibiotika alene.
English: • pain following minor soft tissue surgery such as castration
Danish: • smerter efter mindre bløddelskirurgi, såsom kastration
English: What benefits of Novem have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Novem?
English: Similarly, treatment combining rehydration solution and Novem was shown to be superior to rehydration solution alone.
Danish: På samme måde viste behandlingen med rehydreringsopløsning og Novem sig at være mere effektiv end rehydreringsopløsningen alene.
English: • acute respiratory infection (infection of the lungs and airways) together with antibiotics
Danish: • akut respiratorisk infektion (infektion i lunger og luftveje) sammen med antibiotika
English: • diarrhoea in calves of over one week of age and young, non-lactating cattle together with oral re hydration therapy (medicines given by mouth to restore water levels in the body)
Danish: • diarré hos kalve, der er mere end én uge gamle, og hos ungkvæg, som ikke er diegivende sammen med oral rehydrering (lægemidler indgivet via munden for at genoprette væskebalancen i kroppen)
English: • pain following dehorning in calves
Danish: • smerter ved afhorning af kalve
English: In pigs, Novem is used to treat:
Danish: Hos svin anvendes Novem til behandling af:
English: In cattle and pigs both subcutaneous and intramuscular administration are well tolerated; only a slight temporary swelling at the injection site following subcutaneous administration was observed in less than 10% of the cattle treated in clinical studies.
Danish: Der forekom kun let og forbigående hævelse på injektionsstedet efter administration under huden hos mindre end 10 % af kvæget i de kliniske undersøgelser.
English: • acute mastitis (inflammation of the udder) together with the main treatment with antibiotics.
Danish: • akut mastitis (yverbetændelse) sammen med den primære behandling med antibiotika.
English: How does Novem work?
Danish: Hvordan virker Novem?
English: Novem is available as a solution for injection and can only be obtained with a prescription.
Danish: Novem fås som injektionsvæske, opløsning, og udleveres kun efter recept.
English: How is Novem used?
Danish: Hvordan anvendes Novem
English: For more information about treatment with Novem, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med Novem, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: • lameness and inflammation in non-infectious locomotor disorders (diseases that affect the ability to move)
Danish: • halten og betændelse i forbindelse med ikkesmittefarlige sygdomme i bevægeapparatet
English: • infections that occur after farrowing (giving birth) such as puerperal septicaemia and toxaemia
Danish: • infektioner, der opstår efter faring (fødsel), såsom puerperal septikæmi og toksæmi (mastitis metritis-agalactia-syndrom) sammen med den primære behandling med antibiotika
English: Annex III Condition for lifting the suspension of the marketing authorisations
Danish: Bilag III Betingelse for ophævelse af suspenderingen af markedsføringstilladelserne
English: Condition for lifting the suspension of the marketing authorisations for Numeta G13%E and associated names
Danish: Betingelse for ophævelse af suspenderingen af markedsføringstilladelserne for Numeta G13%E og relaterede navne
English: The MAH should reformulate the product, to include a level of magnesium which is justified based on the most recent knowledge in the area.
Danish: Indehaveren af markedsføringstilladelsen omformulerer produktet til et magnesiumindhold, der er begrundet i den nyeste viden på området.
English: For the suspension of the marketing authorisations of Numeta G13%E to be lifted, the National competent authorities of Member States shall verify that the following conditions are fulfilled by the MAH:
Danish: For at suspenderingen af markedsføringstilladelserne for Numeta G13%E kan ophæves, sikrer medlemsstaternes kompetente myndigheder, at følgende betingelser er opfyldt af indehaveren af markedsføringstilladelsen:
English: The MAH should liaise with the Reference Member State to agree on the appropriate procedure to be used for the fulfilment of this condition.
Danish: Indehaveren af markedsføringstilladelsen aftaler med referencemedlemsstaten en hensigtsmæssig procedure til opfyldelse af denne betingelse for ophævelse af suspenderingen.
English: --1 Hydrocortisone aceponate: 1.11 mg/ml; Miconazole (as nitrate form): 15.1 mg/ml; Gentamicin (as sulphate form): 1,505 IU/ml.
Danish: --1 Hydrocortison aceponat: 1,11 mg/ml ; Miconazol: 15,1 mg/ml ; Gentamycin (som sulfat): 1505 IU/ml.
English: Pharmaceutical form
Danish: Særnavn Styrke Lægemiddelform
English: Auricular use Multi-dose container (PP)
Danish: Multidosis-beholder med pumpe
English: 1 container
Danish: 1 flaske
English: Content Package size Withdrawal period
Danish: Indhold Pakningsstørrel se
English: EMA/CHMP/761027/2012 EMEA/H/C/002506
Danish: EMEA/H/C/002506
English: The reference medicine for Solumarv in this application was Humulin S.
Danish: Referencelægemidlet for Solumarv i denne ansøgning var Humulin S.
English: What consequences does this withdrawal have for patients in clinical trials?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med ?
English: For more information on biosimilar medicines, see the questions-and-answers document here.
Danish: Der kan hentes yderligere oplysninger om biosimilære lægemidler i dokumentet med spørgsmål og svar her.
English: The application was a joint application from Marvel LifeSciences for Solumarv and two other medicines (Isomarv medium and Combimarv, also developed as biosimilar medicines).
Danish: Ansøgningen var en fælles ansøgning fra Marvel LifeSciences for Solumarv og to andre lægemidler (Isomarv medium og Combimarv, der ligeledes er udviklet som biosimilære lægemidler).
English: 13 December 2012
Danish: Den 13. december 2012 EMA/130127/2013
English: Solumarv was developed as a biosimilar medicine.
Danish: Solumarv blev udviklet som et biosimilært lægemiddel.
English: What was Solumarv expected to be used for?
Danish: Hvad forventedes Solumarv anvendt til?
English: What is Solumarv?
Danish: Hvad er Solumarv?
English: After its initial assessment, the CHMP had significant concerns and was of the provisional opinion that Solumarv could not have been approved.
Danish: Efter den indledende vurdering havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Solumarv ikke kunne godkendes.
English: The initial concerns related mainly to the manufacture of the medicine and whether Solumarv was sufficiently similar to its reference medicine.
Danish: De indledende betænkeligheder vedrørte hovedsagelig fremstillingen af lægemidlet, og hvorvidt Solumarv tilstrækkeligt svarede til referencelægemidlet.
English: The company informed the CHMP that at the time of the withdrawal no patients were receiving Solumarv in clinical trials.
Danish: Virksomheden har til CHMP oplyst, at der på tilbagetrækningstidspunktet ikke var patienter, som blev behandlet med Solumarv i kliniske undersøgelser
English: The insulin in Solumarv is produced by a method known as ‘recombinant DNA technology': it is made by bacteria that have received a gene (DNA) which makes the bacteria able to produce the insulin.
Danish: Insulinet i Solumarv fremstilles ved "rekombinant DNA-teknologi": Det produceres af en bakterie, der har fået indsat et gen (DNA), som gør den i stand til at producere insulin.
English: On 15 November 2012, Marvel LifeSciences Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Solumarv, intended for the treatment of patients with diabetes who require insulin to control their blood glucose.
Danish: Den 15. november 2012 meddelte Marvel LifeSciences Ltd officielt til Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning tilbage om markedsføringstilladelse for Solumarv til behandling af patienter med sukkersyge, som behøver insulin til regulering af blodsukkeret.
English: Among these were results from studies that looked at how the body handles Solumarv compared with Humulin S and how these insulins affect blood sugar levels.
Danish: Der var blandt andet tale om undersøgelser af, hvordan kroppen håndterer Solumarv sammenlignet med Humulin S, og hvordan disse insuliner påvirker blodsukkeret.
English: The company presented the results of studies designed to show that Solumarv is similar to its reference medicine Humulin S in terms of its structure, biological activity and clinical performance.
Danish: Virksomheden fremlagde resultaterne af undersøgelser, der skulle vise, at Solumarv svarer til referencelægemidlet Humulin S hvad angår struktur, biologisk aktivitet og kliniske virkninger.
English: Solumarv is a medicine that contains the active substance human insulin.
Danish: Solumarv er et lægemiddel, der indeholder det aktive stof insulin, humant.
English: How is Solumarv expected to work?
Danish: Hvordan forventes Solumarv at virke?
English: It was to be available as a solution for injection.
Danish: Det var hensigten, at det skulle leveres som injektionsvæske, opløsning.
English: Solumarv was expected to be used to treat patients with diabetes who require insulin to control their blood glucose (sugar).
Danish: Solumarv forventedes anvendt til behandling af patienter med sukkersyge, som behøver insulin til regulering af blodsukkeret.
English: Solumarv was intended as a replacement insulin that is similar to the insulin made by the body.
Danish: Det var hensigten, at Solumarv skulle være et erstatningsinsulin, der stærkt ligner det insulin, som kroppen producerer.
English: Conditions to the marketing authorisation
Danish: Betingelser for markedsføringstilladelserne
English: This material shall inform about the
Danish: Dette materiale skal indeholde oplysninger om
English: If the tag is provided as part of the medicinal product, it should be incorporated in the product information via a variation procedure
Danish: Hvis denne etiket leveres som en del af lægemidlet, skal den indsættes i produktinformationen gennem en ændringsansøgning.
English: The Marketing Authorisation Holder shall agree the exact content and format of the educational material and educational program with the national competent authority.
Danish: Indehaveren af markedsføringstilladelsen aftaler de nærmere enkeltheder om indhold og form af uddannelsesmaterialet og uddannelsesprogrammet med de nationale kompetente myndigheder.
English: • use of pressurized CO2 only
Danish: • at kun CO2-gas må anvendes
English: The material shall include the latest Summary of Product Characteristics and the section titled “The following information is intended for medical or healthcare professionals only” of the latest package leaflet.
Danish: Dette materiale skal indbefatte det seneste produktresumé og afsnittet "Følgende oplysninger er kun til brug for medicinsk personale" i den seneste indlægsseddel.
English: The program shall teach the content of the mentioned educational material.
Danish: Dette program skal omfatte instruktion i det nævnte uddannelsesmateriale.
English: • restriction to open surgery
Danish: • begrænsningen af anvendelsen til åbne kirurgiske indgreb
English: • requirement to dry the wound using standard techniques (e.g. intermittent application of compresses, swabs, use of suction devices) prior to using the product
Danish: • kravet om tørring af såret med standardteknikker (f.eks. intermitterende påføring af kompresser og brug af sug), før produktet anvendes
English: • risk of life-threatening gas embolism if the product is sprayed incorrectly
Danish: • risikoen for livstruende gasemboli ved ukorrekt spraypåføring af produktet
English: • requirement to closely monitor blood pressure, pulse rate, oxygen saturation and end tidal CO2 when spraying the product, for the occurrence of gas embolism.
Danish: • kravet om tæt overvågning af blodtryk, puls, iltmætning og slutekspiratorisk CO2 ved spraypåføring af produktet med henblik på forekomst af gasemboli
English: • which regulator(s) should be used, in line with manufacturer recommendations and the SmPC instructions for use
Danish: • hvilke(n) regulator(er), der skal anvendes alt efter producentens anvisninger og brugsanvisningen i produktresuméet.
English: • a yellow tag, to be placed on the device air hose, which provides instructions for use.
Danish: • en gul etiket, der skal anbringes på anordningens trykluftslange og er forsynet med anvisninger for brug.
English: The MAH shall offer an educational program to all users of the spray application of this product.
Danish: Indehaveren af markedsføringstilladelsen skal tilbyde et uddannelsesprogram til alle, der anvender produktet ved spraypåføring.
English: • labels for the pressure regulator that inform about the correct pressure and distance in open surgery
Danish: • etiketter til trykregulatoren med et symbol, der informerer om de korrekte værdier af tryk og sprøjteafstand ved åbne kirurgiske indgreb
English: • correct pressure and distance from tissue
Danish: • korrekt påføringstryk og afstand fra vævet ved påføring
English: • a warning card that informs about the correct pressure and distance for the spray application for open surgery
Danish: • et advarselskort, der informerer om korrekt tryk og korrekt sprøjteafstand ved spraypåføring under åbne kirurgiske indgreb
English: The MAH shall ensure that, at the time of the European Commission decision for this procedure (EMEA/H/A-31/1337), all users of the spray application of this product are provided with educational material.
Danish: Indehaveren af markedsføringstilladelsen drager omsorg for, at alle, der bruger dette produkt ved spraypåføring, på tidspunktet for Europa-Kommissionens afgørelse om denne procedure (EMEA/H/A-31/1337), modtager uddannelsesmateriale.
English: The Marketing Authorisation Holder (MAH) shall submit to the national competent authority, within one month of the European Commission decision on this procedure (EMEA/H/A-31/1337), an EU risk management plan for the product according to the EU Good Vigilance Practices which includes the safety concern of gas embolism.
Danish: Senest en måned efter Europa-Kommissionens afgørelse om denne procedure (EMEA/H/A31/1337) indsender markedsføringstilladelsesindehaveren en EU-risikostyringsplan for produktet til de nationale kompetente myndigheder.
English: The MAH shall ensure that, within two years of the European Commission decision on this procedure (EMEA/H/A-31/1337), the product can only be used with a pressure regulator that caps the maximum pressure at 2.5 bars.
Danish: Indehaveren af markedsføringstilladelsen drager omsorg for, at produktet kun kan bruges med en trykregulator, der begrænser det maksimale tryk til 2,5 bar, senest to år efter EuropaKommissionens afgørelse om denne procedure (EMEA/H/A-31/1337).
English: The MAH shall ensure that, within three months of the European Commission decision on this procedure (EMEA/H/A-31/1337), all users of the spray application of this product are provided with
Danish: Indehaveren af markedsføringstilladelsen drager omsorg for, at alle, der bruger dette produkt ved spraypåføring, senest tre måneder efter Europa-Kommissionens afgørelse om denne procedure (EMEA/H/A-31/1337), modtager følgende:
English: The patient should take the tablets at around the same time each day, usually in the morning.
Danish: Patienten skal tage tabletterne på samme tidspunkt hver dag og helst om morgenen.
English: Treatment courses should be continued for as long as the medicine continues to work and the patient does not get unacceptable side effects.
Danish: Behandlingscyklusserne bør fortsætte, lige så længe lægemidlet fortsætter med at virke, og patienten ikke får uacceptable bivirkninger.
English: The mean measure of effectiveness was how long the women lived without their disease getting worse (progression-free survival).
Danish: Virkningen blev hovedsagelig målt på, hvor længe kvinderne levede, uden at deres sygdom blev værre (progressionsfri overlevelse).
English: The usual recommended dose is 3 tablets (600 mg) once daily for 21 days followed by a 7-day break to complete a 28-day treatment course.
Danish: Den sædvanlige anbefalede dosis er 3 tabletter (600 mg) én gang dagligt i 21 dage efterfulgt af 7 dages pause, dvs. en behandlingscyklus på i alt 28 dage.
English: This is a summary of the European public assessment report (EPAR) for Kisqali.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Kisqali.
English: The full EPAR for Kisqali can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Kisqali findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Kisqali
Danish: Andre oplysninger om Kisqali
English: The European Medicines Agency decided that Kisqali's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Kisqali opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: If the patient gets severe side effects the doctor may reduce the dose of Kisqali, or interrupt or stop treatment with the medicine.
Danish: Hvis patienten får alvorlige bivirkninger, kan lægen reducere dosis af Kisqali eller afbryde eller standse behandlingen med lægemidlet.
English: What measures are being taken to ensure the safe and effective use of Kisqali?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Kisqali?
English: Kisqali can only be used when the cancer cells have receptors for certain hormones on their surface (HR-positive) and do not have large quantities of another receptor called HER2 (HER2-negative).
Danish: Kisqali kan kun anvendes, når kræftcellerne har receptorer for visse hormoner på deres overflade (HRpositive) og ikke har store mængder af en anden receptor, der hedder HER2 (HER2-negative).
English: Kisqali is available as 200-mg tablets.
Danish: Kisqali fås som tabletter a 200 mg.
English: Kisqali contains the active substance ribociclib.
Danish: Kisqali indeholder det aktive stof ribociclib.
English: By blocking CDK4 and CDK6, Kisqali slows the growth of HR-positive breast cancer cells.
Danish: Ved at blokere CDK4 og CDK6 nedsætter Kisqali væksten af HR-positive brystkræftceller.
English: Kisqali was found to be effective in one main study involving 668 women with HR-positive, HER2negative breast cancer.
Danish: Kisqali viste sig at være effektivt i en hovedundersøgelse, der omfattede 668 kvinder med HR-positiv, HER2-negativ brystkræft.
English: The active substance in Kisqali, ribociclib, blocks the activity of enzymes known as cyclin-dependent kinases (CDK) 4 and 6, which are important for regulating the way cells grow and divide.
Danish: Det aktive stof i Kisqali, ribociclib, blokerer aktiviteten af cyklinafhængige kinaser (CDK4 og CDK6), enzymer, som er vigtige for reguleringen af den måde, celler vokser og deler sig på.
English: Kisqali can only be obtained with a prescription and treatment should be started by a doctor experienced in the use of cancer treatments.
Danish: Kisqali udleveres kun efter recept, og behandlingen skal indledes af en læge med erfaring i brug af kræftbehandling.
English: The Agency considered that Kisqali's pattern of side effects has been fairly well established and the side effects appear manageable.
Danish: Agenturet var af den opfattelse, at Kisqalis bivirkningsmønster er rimelig veldokumenteret, og at bivirkningerne lader til at være håndterbare.
English: It is not intended to provide practical advice on how to use Kisqali.
Danish: Det er ikke en praktisk vejledning i, hvordan Kisqali bør anvendes.
English: Kisqali must not be used in patients who are hypersensitive (allergic) to any of the ingredients or to peanuts or soya.
Danish: Kisqali må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for nogen af indholdsstofferne eller over for jordnødder eller soja.
English: In this study, women received either Kisqali with letrozole (an aromatase inhibitor) or placebo (a dummy treatment) with letrozole.
Danish: I denne undersøgelse fik kvinderne enten Kisqali sammen med letrozol (en aromatasehæmmer) eller placebo (en uvirksom behandling) sammen med letrozol.