FrancophonIA/ELRC3.0 huggingface dataset:
English: In cattle, Rheumocam is used together with appropriate antibiotic therapy, to reduce clinical signs of acute respiratory infection (infection of the lungs and airways).
Danish: Hos kvæg anvendes Rheumocam i kombination med passende antibiotikabehandling til at mindske de kliniske symptomer på akut respiratorisk infektion (infektion i lungerne og luftvejene).
English: Rheumocam is available as granules, an oral (taken by mouth) suspension, chewable tablets and a solution for injection.
Danish: Rheumocam fås som granulat, en oral suspension (dvs. en suspension, som indtages gennem munden), tyggetabletter og en opløsning til injektion.
English: In horses, Rheumocam is used to reduce pain associated with colic (abdominal pain) and to lessen inflammation and relieve pain in acute and chronic musculo-skeletal disorders (disorders affecting the muscles and bones).
Danish: Hos heste anvendes Rheumocam til at lindre smerter forbundet med kolik (mavesmerter) og til at reducere betændelse og lindre smerter i forbindelse med akutte og kroniske muskuloskeletale lidelser (lidelser, der berører musklerne og knoglerne).
English: How has Rheumocam been studied?
Danish: Hvordan blev Rheumocam undersøgt?
English: Moreover, it is used to lessen pain and inflammation in acute and chronic musculo-skeletal disorders.
Danish: Det anvendes desuden til at lindre smerter og reducere betændelse ved akutte og kroniske muskuloskeletale lidelser.
English: Moreover, it is used to lessen inflammation and pain in acute and chronic musculo-skeletal disorders.
Danish: Det anvendes desuden til at reducere betændelse og lindre smerter ved akutte og kroniske muskuloskeletale lidelser.
English: In cats, Rheumocam is used to reduce post-operative pain and inflammation after ovariohysterectomy (spaying operation), orthopaedic and minor soft tissue surgery.
Danish: Hos katte anvendes Rheumocam til at lindre postoperative smerter og reducere betændelse efter ovariehysterektomi (sterilisationsindgreb), ortopædkirurgi og mindre bløddelskirurgi.
English: How does Rheumocam work?
Danish: Hvordan virker Rheumocam?
English: How is Rheumocam used?
Danish: Hvordan anvendes Rheumocam?
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: Prostaglandiner er stoffer, der udløser betændelse, smerter, ekssudation (væskeudskillelse fra blodkarrene under betændelse) og feber.
English: In dogs, Rheumocam is used to reduce post-operative pain and inflammation following orthopaedic (e.g. fracture operation) and soft tissue surgery.
Danish: Hos hunde anvendes Rheumocam til at lindre postoperative smerter og reducere betændelse efter ortopædkirurgi (f.eks. operation i forbindelse med knoglebrud) og bløddelskirurgi.
English: This summary was last updated in: 04-2013.
Danish: Dette sammendrag blev sidst ajourført i: 04-2013.
English: This is related to the mode of action of the product.
Danish: Dette hænger sammen med produktets virkemåde.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Slentrol on 13.04.2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Slentrol den 13.04.2007.
English: Some dogs (less than 10%) experienced repeated vomiting (i.e. more than once every 20 days on average).
Danish: Nogle hunde (under 10 %) fik gentagne opkastninger (dvs. mere end én gang hver 20. dag i gennemsnit).
English: In most cases, these effects are mild and stop without any treatment.
Danish: I de fleste tilfælde er disse virkninger milde og svinder uden behandling.
English: Dirlotapide
Danish: Dirlotapid
English: This veterinary medicine has been developed especially for dogs and is not for use in humans.
Danish: Dette veterinære lægemiddel er specielt udviklet til hunde og er ikke beregnet til brug hos mennesker.
English: It is available in three pack sizes; 20 ml, 50 ml and 150 ml and supplied with appropriate dosing devices.
Danish: Det leveres i tre pakningsstørrelser: 20 ml, 50 ml og 150 ml, med passende doseringsanordning.
English: Slentrol has been studied in a large number of dogs in both laboratory and field trials for up to one year.
Danish: Slentrol blev undersøgt hos et stort antal hunde i både laboratorie- og feltundersøgelser af indtil et års varighed.
English: Other information about Slentrol:
Danish: Andre oplysninger om Slentrol:
English: The weight lowering effect was up to 20 % after 6 months of therapy in the initial weight loss phase of treatment.
Danish: Den vægtsænkende virkning var indtil 20 % efter 6 måneders i den indledende vægttabsfase af behandlingen.
English: Two large field trials were conducted, one in Europe and one in the USA, in healthy dogs which had a bodyweight higher than recommended.
Danish: Der blev udført to store feltundersøgelser, den ene i Europa, den anden i USA, hos raske hunde med kropsvægt over den anbefalede.
English: The dogs also received other medicines during the study as required, such as anti-inflammatory drugs (including NSAIDs), antimicrobials, parasiticides, vaccines, dietary supplements, vitamins, hormones and cardiovascular drugs.
Danish: Hundene fik desuden efter behov anden medicin i løbet af undersøgelsen, f.eks. antiinflammatoriske lægemidler (herunder NSAID), antibiotika, parasitdræbende midler, vacciner, fodertilskud, vitaminer, hormoner og medicin mod hjertekarsygdomme.
English: The product can be administered with or without food for up to 12 months.
Danish: Produktet kan gives sammen med foderet eller mellem måltiderne i indtil 12 måneder.
English: The active substance in Slentrol, dirlotapide, works in the gut by blocking a protein (the microsomal triglyceride transfer protein).
Danish: Det aktive stof i Slentrol, dirlotapid, virker i tarmen ved at blokere et protein (det mikrosomale triglycerid transfer protein).
English: It is to be used as part of an overall weight management programme which also includes appropriate dietary changes and exercise practice.
Danish: Det anvendes som et led i et samlet vægtkontrolprogram, der også indebærer passende foderændringer og motion.
English: If a person accidentally takes the medicine, seek medical advice immediately and show the package leaflet or the label to a doctor.
Danish: Hvis en person indtager produktet ved hændeligt uheld, skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
English: The majority of the weight loss occurs as a result of appetite suppression.
Danish: Størstedelen af vægttabet skyldes appetitnedsættelsen.
English: Specific interactions were not investigated.
Danish: Der blev ikke undersøgt for bestemte vekselvirkninger mellem lægemidlerne.
English: The medicine is administered to the dog for 2 weeks, and after the first 2 weeks the veterinarian will double the initial dose for a further 2 weeks.
Danish: Hunden får medicinen i to uger, hvorefter dyrlægen forhøjer dosis til den dobbelte i yderligere to uger.
English: What is the risk associated with Slentrol?
Danish: Hvilken risiko er der forbundet med Slentrol?
English: If accidental skin or eye contact occurs, flush immediately with lots of water.
Danish: Ved utilsigtet kontakt med hud eller øjne skal det pågældende område straks skylles med rigeligt vand.
English: The treatment is an initial measure in an obesity management programme; it has to be combined with changes in diet, which must be continued after treatment is finished.
Danish: Behandlingen er det indledende skridt i et vægtkontrolprogram og skal kombineres med foderændringer, som skal opretholdes, når behandlingen er afsluttet.
English: Some dogs received Slentrol while the remainder received the medicine with the active substance removed (control group).
Danish: Nogle af hundene fik Slentrol, mens resten (kontrolgruppen) fik medicin uden aktivt stof.
English: What is Slentrol?
Danish: Hvad er Slentrol?
English: Slentrol is an oral solution, colourless to pale yellow in colour.
Danish: Slentrol er en oral opløsning, der er farveløs til gullig.
English: Rebound weight gain was seen after treatment was completed.
Danish: Tilbagefald af vægtøgning sås efter ophør af behandlingen.
English: How has Slentrol been studied?
Danish: Hvordan blev Slentrol undersøgt?
English: Slentrol at the recommended dose of 5 mg/ml and using the recommended treatment schedule reduced body weight in obese dogs when compared to the control group.
Danish: Når den anbefalede dosis på 5 mg/ml og den anbefalede behandlingsplan blev overholdt, mindskede Slentrol kropsvægten hos overvægtige hunde i forhold til kontrolgruppen.
English: What is Slentrol used for?
Danish: Hvad anvendes Slentrol til?
English: This protein is normally involved in the absorption of fats from the diet. By blocking the protein Slentrol decreases the absorption of fats from the gut and this change in fat absorption has an appetite suppressant effect.
Danish: Ved at blokere proteinet nedsætter Slentrol optagelsen af fedtstoffer fra tarmen, og denne ændrede fedtabsorption virker appetitnedsættende.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Slentrol excede the risks for the management of overweight and obesity in adult dogs and recommended that Slentrol be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Slentrol opvejer risiciene til behandling af overvægt og fedme hos voksne hunde.
English: Vomiting, sometimes accompanied by signs of lethargy, diarrhoea or softened faeces may occur during treatment.
Danish: Under behandlingen kan der forekomme opkastning, undertiden ledsaget af tegn på sløvhed, diarré eller blød afføring.
English: Slentrol contains the active substance dirlotapide which helps to reduce weight in dogs.
Danish: Slentrol indeholder det aktive stof dirlotapid, der anvendes som slankemiddel til hunde.
English: Following these initial 4 weeks of therapy, dogs should be weighed monthly during treatment with the product and dose adjustments are made monthly according to the weight loss achieved.
Danish: Efter disse første fire ugers behandling bør hunden vejes en gang om måneden, så længe den er i behandling med produktet.
English: A reduced appetite may also occur during treatment.
Danish: Behandlingen kan også medføre nedsat ædelyst.
English: For a full list of all side-effects reported with Slentrol, see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger for Slentrol fremgår af indlægssedlen.
English: Certain medications, e.g. drugs that lower serum cholesterol or other serum lipids, or drugs that affect appetite and/or body weight, e.g. long-acting glucorticoids, were not permitted for use during the study.
Danish: Dette gælder f.eks. kolesterol- eller lidpidsænkende midler og lægemidler, der påvirker ædelyst og/eller kropsvægt, f.eks. langtidsvirkende glukokortikoider.
English: What benefit has Slentrol shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Slentrol?
English: Slentrol is used in adult dogs that are overweight or obese, to help them lose weight.
Danish: Slentrol anvendes som slankemiddel til voksne hunde, der lider af overvægt eller fedme.
English: It is available as capsules (5 mg; 20 mg; 100 mg; 140 mg; 180 mg; 250 mg).
Danish: Det fås som kapsler (5 mg, 20 mg, 100 mg, 140 mg, 180 mg og 250 mg).
English: Temozolomide Accord should be taken without food.
Danish: Temozolomide Accord bør tages uden mad.
English: The full EPAR for Temozolomide Accord can be found can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Temozolomide Accord findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: MTIC binds to the DNA of cells while they are reproducing, which stops cell division.
Danish: MTIC binder sig til DNA'et i cellerne, mens disse reproducerer sig selv, hvorved celledelingen standses.
English: The name of the medicine was changed to Temozolomide Accord on 27 May 2015.
Danish: Lægemidlets navn blev ændret til Temozolomide Accord den 27. maj 2015.
English: The dose and the number of doses depend on the type of tumour being treated, whether the patient has been treated before, whether Temozolomide Accord is being used alone or with other treatments, and how the patient responds to treatment.
Danish: Dosis og antallet af doser afhænger af, hvilken type svulst der skal behandles, om patienten er blevet behandlet før, om Temozolomide Accord anvendes alene eller sammen med andre behandlinger og af, hvordan patienten responderer på behandlingen.
English: The European Commission granted a marketing authorisation valid throughout the EU for Temozolomide Hospira on 15 March 2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Temozolomide Hospira den 15. marts 2010.
English: Temozolomide Accord is used on its own in these patients.
Danish: Temozolomide Accord anvendes alene hos disse patienter.
English: This is a summary of the European Public Assessment Report (EPAR) for Temozolomide Accord.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Temozolomide Accord.
English: The dose of Temozolomide Accord depends on body surface area (calculated using the patient's height and weight) and ranges from 75 to 200 mg per square metre, once a day.
Danish: Dosis af Temozolomide Accord afhænger af kropsoverfladen (beregnet ud fra patientens højde og vægt) og ligger på mellem 75 mg og 200 mg pr. kvadratmeter en gang dagligt.
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 Temozolomide Accord.
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, hvordan Temozolomide Accord skal anvendes.
English: This means that Temozolomide Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Temodal.
Danish: Det betyder, at Temozolomide Accord er identisk med et ‘referencelægemiddel', som allerede er godkendt i Den Europæiske Union (EU), og som hedder Temodal.
English: For more information about treatment with Temozolomide Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Temozolomide Accord, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Temozolomide Accord is used first with radiotherapy and then on its own;
Danish: Temozolomide Accord bruges først sammen med strålebehandling og herefter alene.
English: 1 Previously known as Temozolomide Hospira.
Danish: 1 Tidligere kaldet Temozolomide Hospira.
English: Temozolomide Accord is used to treat malignant glioma (brain tumours) in the following groups of patients:
Danish: Temozolomide Accord anvendes til behandling af ondartet gliom (svulster i hjernen) hos følgende patientgrupper:
English: Patients may also need to take medicines to prevent vomiting before taking Temozolomide Accord.
Danish: Det kan ligeledes være nødvendigt at give patienten et middel mod opkastninger inden indtagelsen af Temozolomide Accord.
English: Temozolomide Accord is a ‘generic medicine'.
Danish: Temozolomide Accord er et ”generisk lægemiddel”.
English: Treatment with Temozolomide Accord should be prescribed by a doctor with experience in the treatment of brain tumours.
Danish: Behandling med Temozolomide Accord skal ordineres af en læge, som har erfaring med behandling af hjernesvulster.
English: The CHMP concluded that, in accordance with EU requirements, Temozolomide Accord has been shown to have comparable quality and to be bioequivalent to Temodal.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Temozolomide Accord er af sammenlignelig kvalitet og er bioækvivalent med Temodal.
English: The Committee recommended that Temozolomide Accord be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Temozolomide Accord.
English: The active substance in Temozolomide Accord, temozolomide, belongs to a group of cancer medicines called alkylating agents.
Danish: Det aktive stof i Temozolomide Accord, temozolomid, tilhører en gruppe af lægemidler mod kræft kaldet alkylerende midler.
English: Temozolomide Accord is a cancer medicine that contains the active substance temozolomide.
Danish: Temozolomide Accord er et lægemiddel mod kræft, der indeholder det aktive stof temozolomid.
English: Because Temozolomide Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Temozolomide Accord er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Other information about Temozolomide Accord:
Danish: Andre oplysninger om Temozolomide Accord
English: What are the benefit and risk of Temozolomide Accord?
Danish: Hvilke fordele og risici er der forbundet med Temozolomide Accord?
English: Because Temozolomide Accord is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Temodal.
Danish: Da Temozolomide Accord er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Temodal.
English: Temozolomide Accord temozolomide
Danish: Temozolomide Accord1
English: Why has Temozolomide Accord been approved?
Danish: Hvorfor blev Temozolomide Accord godkendt?
English: How has Temozolomide Accord been studied?
Danish: Hvordan blev Temozolomide Accord undersøgt?
English: What is Temozolomide Accord?
Danish: Hvad er Temozolomide Accord?
English: What is Temozolomide Accord used for?
Danish: Hvad anvendes Temozolomide Accord til?
English: How is Temozolomide Accord used?
Danish: Hvordan anvendes Temozolomide Accord?
English: How does Temozolomide Accord work?
Danish: Hvordan virker Temozolomide Accord?
English: Time (Weeks)
Danish: Tid (uger)
English: Such signs are listed under “Serious side effects” in section 4.
Danish: Disse tegn er anført under ”Alvorlige bivirkninger” i punkt 4.
English: Date of first authorisation: 15 January 2015 Date of latest renewal: 03 September 2019
Danish: Dato for første markedsføringstilladelse: 15. januar 2015 Dato for seneste fornyelse: 3. september 2019
English: Patients should be closely monitored.
Danish: Patienter skal monitoreres tæt.
English: These improvements were maintained for 52 weeks (studies 1 and 2).
Danish: Disse forbedringer blev opretholdt i 52 uger (studie 1 og 2).
English: There were no reported cases of more severe neutropenia.
Danish: Der blev ikke rapporteret tilfælde af mere svær neutropeni.
English: • if you have Crohn's disease.
Danish: • hvis du har Crohns sygdom.
English: Your doctor will decide if and when you may restart the treatment.
Danish: Din læge vil beslutte, om og hvornår du kan genoptage behandlingen.
English: PASI % change from baseline
Danish: PASI % ændring fra baseline
English: DAS28-CRP Week 16
Danish: DAS28-CRP Uge 16
English: Most of the following side effects are mild to moderate.
Danish: De fleste af nedenstående bivirkninger er milde til moderate.
English: The CL was not impacted by gender.
Danish: CL var ikke afhængig af køn.
English: All patients were followed for up to 52 weeks following first administration of study treatment.
Danish: Alle patienterne blev fulgt i op til 52 uger efter første administration af studiebehandlingen.
English: • if you have ulcerative colitis.
Danish: • hvis du har ulcerativ colitis.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske lægemidler skal navn og batchnummeret for det administrerede lægemiddel registreres tydeligt.
English: For all of the above indications, available data suggest that a clinical response is usually achieved within 16 weeks of treatment.
Danish: For alle ovenstående indikationer tyder tilgængelige data på, at et klinisk respons sædvanligvis opnås inden for 16 ugers behandling.
English: The number of PsA patients with axial involvement was too small to allow meaningful assessment.
Danish: Antallet af PsA-patienter med aksial inddragelse var for lille til at muliggøre en meningsfuld vurdering.
English: • Never try to reuse your pen.
Danish: • Forsøg aldrig at genbruge din pen.
English: 9/l (CTCAE grade 4) were reported.
Danish: 9/l (CTCAE-grad 4) er blevet indberettet.
English: • if you have long-term or repeated infections.
Danish: • hvis du har langvarige eller gentagne infektioner.
English: However, the physician should ensure appropriate follow-up of patients.
Danish: Lægen skal dog sikre passende opfølgning af patienterne.
English: The effects of this medicine in pregnant women are not known.
Danish: Effekten af dette lægemiddel hos gravide kvinder er ikke kendt.
English: • if you have an active infection which your doctor thinks is important.
Danish: hvis du har en aktiv infektion, som din læge mener er af betydning
English: Spinal mobility
Danish: Spinal mobilitet
English: Of these, over 11,700 patients were exposed to secukinumab for at least one year.
Danish: Ud af disse blev mere end 11.700 patienter eksponeret for secukinumab i mindst et år.
English: Patients in these studies had a diagnosis of PsA of at least five years.
Danish: Patienter i disse studier havde haft diagnosen PsA i mindst fem år.
English: Across studies, absolute bioavailabilities in the range between 60 and 77% were calculated.
Danish: På tværs af studier blev der beregnet absolutte biotilgængeligheder i området mellem 60 og 77 %.
English: The safety profile of secukinumab is consistent across all indications.
Danish: Sikkerhedsprofilen for secukinumab er konsistent på tværs af alle indikationer.
English: • if you have ever had an allergic reaction to latex.
Danish: • hvis du på noget tidspunkt har haft en allergisk reaktion over for latex.
English: • if you have tuberculosis.
Danish: • hvis du har tuberkulose.
English: Improvements were shown in all components of the ACR scores, including patient assessment of pain.
Danish: Der blev påvist forbedringer i alle komponenter i ACR-scoren, inklusive patientvurdering af smerte.
English: These improvements were sustained up to week 52.
Danish: Disse forbedringer blev opretholdt til uge 52.
English: Outcome (p-value versus placebo)
Danish: Resultat (p-værdi versus placebo)
English: For all studies, the primary endpoint was American College of Rheumatology (ACR) 20 response.
Danish: I alle studier var det primære endepunkt American College of Rheumatology (ACR) 20-respons.
English: Patients randomised to “retreatment as needed” did not achieve adequate maintenance of response and therefore a fixed monthly maintenance regimen is recommended.
Danish: Patienter, der blev randomiseret til ”behandling efter behov” opnåede ikke tilstrækkelig vedligeholdelse af effekten, og et fast månedligt vedligeholdelsesregime anbefales derfor.
English: In addition, one study assessed a chronic treatment regimen versus a “retreatment as needed” regimen [SCULPTURE].
Danish: Derudover vurderede et studie et kronisk behandlingsregime kontra et ”behandling efter behov”-regime [SCULPTURE].
English: Secukinumab has the potential to increase the risk of infections.
Danish: Secukinumab kan potentielt øge risikoen for infektioner.
English: • if you currently have an infection
Danish: • hvis du i øjeblikket har en infektion
English: ASAS 40 response, % hsCRP, (post-BSL/BSL ratio)
Danish: ASAS 40-respons, % hsCRP, (post-BSL/BSL-ratio)