FrancophonIA/ELRC3.0 huggingface dataset:
English: This summary was last updated: March 2012.
Danish: Dette sammendrag blev sidst ajourført i marts 2012.
English: These side effects occur usually within the first week of treatment and are generally transient (temporary).
Danish: Disse bivirkninger opstår som regel inden for den første uge af behandlingen og er generelt forbigående (midlertidige).
English: Other information about Meloxivet:
Danish: Andre oplysninger om Meloxivet:
English: People who are hypersensitive (allergic) to NSAIDs should avoid contact with Meloxivet.
Danish: Personer, som er overfølsomme (allergiske) over for NSAID'er, skal undgå kontakt med Meloxivet.
English: The amount of suspension to be used is measured using a special dosing syringe (provided in the package), and poured on the food.
Danish: Den mængde suspension, der skal anvendes, måles ved hjælp af en særlig doseringssprøjte (vedlagt pakningen) og hældes over foderet.
English: Meloxivet contains meloxicam, which belongs to a class of medicines called nonsteroidal antiinflammatory drugs (NSAIDs).
Danish: Meloxivet indeholder meloxicam, som tilhører gruppen af lægemidler kaldet ikke-steroide antiinflammatoriske lægemidler (NSAID'er).
English: As the prostaglandins are substances that trigger inflammation, pain, exudation and fever, meloxicam reduces those responses.
Danish: Da prostaglandiner er de stoffer, der udløser betændelse, smerter, udskillelse af væske og feber, reducerer meloxicam disse reaktioner.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Meloxivet on 14 November 2007 Information on the prescription status of this product may be found on the label of the carton.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Meloxivet den 14. november 2007.
English: Meloxivet is a white to yellowish opaque oral suspension which is to be given mixed with food.
Danish: Meloxivet er en hvid til gullig uigennemsigtig oral suspension, som gives opblandet i foder.
English: Occasional side effects of Meloxivet are those seen with NSAIDs, such as loss of appetite, vomiting, diarrhoea, blood appearing in the stools and apathy (lack of vitality).
Danish: De bivirkninger, der undertiden ses ved Metacam, er dem der normalt ses ved NSAID'er såsom nedsat appetit, opkastning, diarré, blod i afføringen og apati (mangel på vitalitet).
English: Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
Danish: Det forklarer, hvordan Udvalget for Veterinærlægemidler (CVMP) vurderede de gennemførte undersøgelser og nåede frem til sine anbefalinger om, hvordan lægemidlet skal anvendes.
English: Why has Meloxivet been approved?
Danish: Hvorfor blev Meloxivet godkendt?
English: Therefore the CVMP's view was that, as for Metacam 1.5 mg/ml oral suspension, Meloxivet's benefits are greater than its risks when treating inflammation or pain in muscles or joints in dogs and they recommended that Meloxivet should be given a marketing authorisation.
Danish: CVMP var derfor af den opfattelse, at Meloxivet ligesom Metacam 1,5 mg/ml oral suspension opvejer risiciene ved behandling af smerter i muskler eller led hos hunde og anbefalede udstedelse af markedsføringstilladelse for Meloxivet.
English: Meloxivet contains the active substance meloxicam and exists in 2 different strengths (0.5 and 1.5 mg/ml, respectively).
Danish: Meloxivet indeholder det aktive stof meloxicam og fås i 2 forskellige styrker (hhv. 0,5 og 1,5 mg/ml).
English: A study looked at how Meloxivet was absorbed and its effects in the body, in comparison with Metacam 1.5 mg/ml oral suspension.
Danish: En undersøgelse så på, hvordan Meloxivet blev optaget i kroppen og på dets virkninger i kroppen i forhold til Metacam 1,5 mg/ml oral suspension.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) considered that, in accordance with European Union requirements, Meloxivet has been shown to be bioequivalent to Metacam 1.5 mg/ml oral suspension.
Danish: Udvalget for Veterinærlægemidler (CVMP) vurderede, at det i overensstemmelse med EU-kravene er blevet påvist, at Meloxivet er bioækvivalent med Metacam 1,5 mg/ml oral suspension.
English: Meloxivet is a ‘generic': this means that Meloxivet is similar to a ‘reference veterinary medicine' already authorised in the EU (Metacam 1.5 mg/ml oral suspension).
Danish: Meloxivet er et ‘generisk produkt' (kopiprodukt), det vil sige, at Meloxivet svarer til et 'referenceveterinærlægemiddel', som allerede er godkendt i EU (Metacam 1,5 mg/ml oral suspension).
English: How has the effectiveness of Meloxivet been studied?
Danish: Hvordan blev virkningen af Meloxivet undersøgt?
English: Meloxivet is used in dogs to relieve inflammation and pain in musculo-skeletal disorders.
Danish: Meloxivet anvendes til lindring af betændelse og smerter ved lidelser i bevægeapparatet hos hunde.
English: Studies have been carried out to prove that Meloxivet is ‘bioequivalent' to the reference veterinary medicine: this means that Meloxivet is equivalent to Metacam 1.5 mg/ml suspension in the way it is absorbed and used by the body.
Danish: Der er blevet udført undersøgelser for at dokumentere, at Meloxivet er 'bioækvivalent' med referenceveterinærlægemidlet, det vil sige, at Meloxivet svarer til Metacam 1,5 mg/ml suspension med hensyn til den måde, hvorpå det optages og anvendes i kroppen.
English: What is Meloxivet?
Danish: Hvad er Meloxivet?
English: Meloxivet is given to the dog once a day, with food, at the dose of 0.2 mg/kg on the first day, then as 0.1 mg/kg afterwards.
Danish: Første dag gives en dosis på 0,2 mg/kg og derefter en dosis på 0,1 mg/kg.
English: What is Meloxivet used for?
Danish: Hvad anvendes Meloxivet til?
English: What are the side-effects of Meloxivet?
Danish: Hvilke bivirkninger har Meloxivet?
English: How does Meloxivet work?
Danish: Hvordan virker Meloxivet?
English: • Caution in use in the elderly in light of age related risks (in particular bladder cancer,
Danish: • Forsigtighed ved brug hos ældre i lyset af aldersbetingede risici (især blærecancer, knoglebrud
English: • The physician educational pack should contain: The Summary of Product Characteristics, package leaflet, and a Prescriber Guide.
Danish: • Informationsmaterialet til lægen bør omfatte: Produktresumé, indlægsseddel og en
English: EU/1/16/1102/001 Bortezomib SUN 3.5 mg Powder for solution for injection Intravenous use, Subcutaneous use vial (glass)
Danish: EU/1/16/1102/001 Bortezomib SUN 3,5 mg Pulver til injektionsvæske, opløsning
English: EU/1/07/424/001 Torisel
Danish: EU/1/07/424/001
English: Intravenous use vial (glass) concentrate: 1.2 ml; solvent: 1.8 ml
Danish: koncentrat: 1.2 ml; solvens 1.8 ml
English: 30 mg Concentrate and solvent for solution for infusion
Danish: 30 mg Koncentrat og solvens til infusionsvæske, opløsning
English: Content (concentration)
Danish: Hætteglas (glas)
English: Route of Administration
Danish: Torisel
English: 4 March 2019
Danish: 4. marts 2019
English: 3 January 2019
Danish: 3. januar 2019
English: The applicant will submit a draft study protocol within 3 months after approval, in Q2 2013 in order to be ready at the time of product launch in 2014.
Danish: Ansøgeren skal indsende et udkast til en forsøgsprotokol senest 3 måneder efter godkendelsen, dvs. i 2. kvartal af 2013 for at være klar på tidspunktet for lanceringen af produktet i 2014.
English: The final study report has been endorsed by the PRAC, and the related condition of the marketing authorisation has been fulfilled.
Danish: Den endelige studierapport er blevet godkendt af PRAC, og den tilknyttede betingelse i markedsføringstilladelsen er opfyldt.
English: The marketing authorisation holder(s) shall remove the following condition(s) (new text underlined and in bold, deleted text strike through):
Danish: Indehaveren/indehaverne af markedsføringstilladelse skal slette følgende betingelse(r) (ny tekst er understreget og med fed skrift, slettet tekst er gennemstreget):
English: The Applicant commits to perform a post authorisation safety study (PASS) to assess drug utilisation in real life setting in a representative sample of the European target population.
Danish: Ansøgeren forpligter sig til at gennemføre en sikkerhedsundersøgelse efter tilladelse til markedsføring (PASS) med henblik på at vurdere anvendelsen af lægemidlet i det virkelige liv i et repræsentativt udsnit af den europæiske målpopulation.
English: November 2018 CMDh meeting
Danish: CMDh-mødenovember 2018
English: The CMDh reaches the position that the marketing authorisation(s) of the products concerned by this PASS final report should be varied.
Danish: CMDh er nået frem til, at markedsføringstilladelsen/-tilladelserne for produkter omfattet af denne endelige PASS-studierapport bør ændres.
English: Therefore, in view of available data regarding the PASS final study report, the PRAC considered that changes to the conditions of the marketing authorisation were warranted.
Danish: Ud fra de foreliggende data vedrørende den endelige PASS-studierapport vurderede PRAC derfor, at betingelserne for markedsføringstilladelsen bør ændres.
English: The results showed that among the study population compliance is very satisfactory; no firm conclusion could be drawn in special populations.
Danish: Der kunne ikke drages nogen tydelig konklusion i særlige populationer.
English: As part of the initial MA procedure (FR/H/511/01/DC), the MAH Ipsen Pharma committed to conduct a DUS to assess drug utilisation in the real life setting in a representative sample of the European target population.
Danish: Som en del af den indledende procedure for udstedelse af markedsføringstilladelse (FR/H/511/01/DC) forpligtede indehaveren af markedsføringstilladelsen Ipsen Pharma sig til at foretage et studie af lægemiddelanvendelse (DUS) for at vurdere anvendelsen af lægemidlet i det virkelige liv i et repræsentativt udsnit af den europæiske målpopulation.
English: Annex II Conditions of Marketing Authorisation
Danish: Bilag II Betingelser for markedsføringstilladelsen/-tilladelserne
English: On the basis of the scientific conclusions for the results of the study for the medicinal product(s) containing the active substance magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate and concerned by the PASS final report , the CMDh is of the opinion that the benefit-risk balance of the medicinal product(s) mentioned above is unchanged subject to the proposed changes to the product information.
Danish: På baggrund af de videnskabelige konklusioner vedrørende studieresultaterne for det lægemiddel/de lægemidler, der indeholder de aktive stoffer magnesiumsulfatheptahydrat, vandfrit natriumsulfat og kaliumsulfat, og som er omfattet af den endelige PASS-studierapport, er CMDh af den opfattelse, at benefit/risk-forholdet for disse lægemidler forbliver uændret, under forudsætning af at de foreslåede ændringer indføres i produktinformationen.
English: Taking into account the PRAC Assessment Report for the non-interventional imposed PASS final report for the medicinal product(s) containing the active substance magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate and concerned by the PASS final report , the scientific conclusions are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport vedrørende den endelige PASS-studierapport (pålagt ikke-interventionssikkerhedsundersøgelse efter tilladelse til markedsføring) for det lægemiddel/de lægemidler, der indeholder de aktive stoffer magnesiumsulfatheptahydrat, vandfrit natriumsulfat og kaliumsulfat, og som er omfattet af den endelige PASS-studierapport, er CMDh nået frem til følgende videnskabelige konklusioner:
English: Changes to be made to the conditions of the marketing authorisation(s) of medicinal product(s) containing the active substance magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate concerned by the non-interventional imposed PASS final report
Danish: Ændringer, der skal indføres i betingelserne for markedsføringstilladelsen/-tilladelserne for det lægemiddel/de lægemidler, der indeholder de aktive stoffer magnesiumsulfatheptahydrat, vandfrit natriumsulfat og kaliumsulfat, og som er omfattet af den endelige PASS-studierapport (pålagt ikke-interventionssikkerhedsundersøgelse efter tilladelse til markedsføring)
English: • if you have or have had alcohol-related problems.
Danish: • hvis du har eller har haft alkoholrelaterede problemer.
English: Increases in temperatures up to 30°C for a total maximum of 3 months do not affect the quality of the product.
Danish: Øget temperatur op til 30°C i maksimalt 3 måneder påvirker ikke produktets kvalitet.
English: This is because this product contains oils which can become solid at low temperatures.
Danish: Dette skyldes, at produktet indeholder olier, som kan stivne ved lave temperaturer.
English: • if you have epilepsy.
Danish: • hvis du har epilepsi.
English: This will get rid of any large air bubbles.
Danish: - Dette fjerner eventuelle store luftbobler.
English: These recommendations apply even if the patient`s values still lie within the laboratory`s normal range.
Danish: Disse anbefalinger gælder selvom patientens værdier stadig ligger inden for laboratoriets normale interval.
English: This depends on your body weight and what you are taking the medicine for.
Danish: Det afhænger af din kropsvægt og hvad du tager medicinen for.
English: These phenomena do not affect the efficacy and safety of the product and the dosing by means of the pipette remains accurate.
Danish: Disse fænomener påvirker ikke produktets virkning og sikkerhed, og dosering med pipette forbliver nøjagtig.
English: In a small percentage of patients these changes are more marked and may be of clinical significance.
Danish: Hos en lille procentdel af patienterne er disse ændringer mere markante og kan have klinisk betydning.
English: In all cases of overdosage, general supportive measures should be followed and symptomatic treatment applied.
Danish: I alle tilfælde af overdosering skal der tages generelle understøttende forholdsregler, og symptomatisk behandling iværksættes.
English: Do not store below 20°C for more than 1 month.
Danish: Må ikke opbevares ved under 20°C i mere end 1 måned.
English: In addition, clinical safety parameters such as renal function and blood pressure must be monitored during the first 2 months after the switch.
Danish: Desuden skal kliniske sikkerhedsparametre, som f.eks. nyrefunktion og blodtryk, monitoreres i løbet af de første 2 måneder efter skiftet.
English: This is normal and does not mean that there is anything wrong with the capsule.
Danish: Dette er normalt og betyder ikke, at der er noget i vejen med kapslen.
English: {Name of the Member State} {Name of the medicinal product} This leaflet was last revised in {MM/YYYY} {month YYYY}.
Danish: Denne indlægsseddel blev senest revideret <{MM/ÅÅÅÅ}> <{måned ÅÅÅÅ}.>
English: In many patients, however, higher peak concentrations (Cmax) and increased exposure to the active substance (AUC) may occur.
Danish: Hos mange patienter kan der dog ses højere peak-koncentrationer (Cmax) og øget eksponering for det aktive stof (AUC).
English: • These medicines all contain ciclosporin as the active ingredient.
Danish: • Disse lægemidler indeholder alle ciclosporin som det aktive indholdsstof.
English: Less than 1% of the administered dose is removed by dialysis.
Danish: Mindre end 1 % af den administrerede dosis blev fjernet ved dialyse.
English: It may also be harmful if this medicine is given to children.
Danish: Det kan også være skadeligt, hvis medicinengives til børn.
English: This is because of the change in how ciclosporin is absorbed into your blood.
Danish: Dette skyldes en ændring i den måde, som ciclosporin optages i blodet på.
English: Minor flakes or slight sediment may still be observed.
Danish: Mindre flager eller en anelse bundfald kan observeres.
English: However, there are no adequate and well-controlled studies in pregnant women and therefore Sandimmun Neoral should not be used during pregnancy unless the potential benefit to the mother justifies the potential risk to the foetus.
Danish: Der findes dog ikke tilstrækkelige og velkontrollerede studier hos gravide kvinder, og derfor bør Sandimmun Neoral ikke anvendes under graviditet, medmindre de mulige fordele for moderen opvejer de mulige risici for fosteret.
English: • if you have low levels of magnesium in your body.
Danish: • hvis du har lavt magnesiumniveau i kroppen.
English: • Medicines which may increase or decrease the level of ciclosporin (the active substance of Sandimmun Neoral) in your blood.
Danish: • Medicin, som kan øge eller reducere mængde af ciclosporin (det aktive stof i Sandimmun Neoral) i blodet.
English: Sandimmun Neoral oral solution should be stored between 15 and 30°C, but preferably not below 20°C for more than 1 month as it contains oily components of natural origin which tend to solidify at low temperatures.
Danish: Sandimmun Neoral oral opløsning skal opbevares ved temperaturer mellem 15 og 30°C, men helst ikke under 20°C i mere end 1 måned, da den indeholder naturlige oliekomponenter, som har tendens til at stivne ved lave temperaturer.
English: This is because this medicine contains alcohol (see section below “Sandimmun Neoral contains ethanol”).
Danish: Det skyldes, at denne medicin indeholder alkohol (se punktet "Sandimmun Neoral indeholder ethanol" nedenfor).
English: The terminal half-life ranged from 6.3 hours in healthy volunteers to 20.4 hours in patients with severe liver disease (see sections 4.2 and 4.4).
Danish: Den terminale halveringstid varierede fra 6,3 timer hos raske frivillige personer til 20,4 timer hos patienter med svær leversygdom (se pkt 4.2 og 4.4).
English: Take Sandimmun Neoral at the same time every day.
Danish: Tag Sandimmun Neoral på samme tidspunkt hver dag.
English: This will give you the chance to talk to your doctor about your treatment and talk about any problems you may be having.
Danish: Her får du mulighed for at tale med lægen om behandlingen og eventuelle problemer.
English: Stir and drink the whole contents of the glass straight away.
Danish: - Rør rundt og drik al indholdet i glasset med det samme.
English: Sandimmun Neoral administration results in a 59% higher Cmax and approximately 29% higher bioavailability than Sandimmun.
Danish: Administration af Sandimmun Neoral resulterede i 59% højere Cmax og ca. 29% højere biotilgængelighed sammenlignet med Sandimmun.
English: In addition the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000) very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: III): meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: A jelly-like formation may occur below 20°C, which is however reversible at temperatures up to 30°C.
Danish: En geleagtig substans kan opstå under 20°C, men er reversibel ved temperaturer på op til 30°C.
English: The intersubject and intrasubject variability for AUC and Cmax is approximately 10-20%.
Danish: Den interindividuelle og intraindividuelle variation for AUC og Cmax er ca. 10-20%.
English: • If you have an autoimmune disease, in which your body's immune response attacks your body's own cells, Sandimmun Neoral stops this immune reaction.
Danish: • Hvis du har en autoimmun sygdom, hvor kroppens immunforsvar angriber kroppens egne celler, standser Sandimmun Neoral denne immunreaktion.
English: After opening, Sandimmun Neoral oral solution should be used within 2 months.
Danish: Efter åbning skal Sandimmun Neoral oral opløsning anvendes inden for 2 måneder.
English: Sandimmun Neoral can be used to induce and maintain remissions.
Danish: Sandimmun Neoral kan bruges til at inducere og opretholde remission.
English: Sandimmun Neoral prevents rejection of transplanted organs by blocking the development of certain cells which would normally attack the transplanted tissue.
Danish: Sandimmun Neoral forhindrer afstødning af transplanterede organer ved at blokere for udviklingen af visse celler, som normalt angriber transplanteret væv.
English: If you are over 65 and have psoriasis or atopic dermatitis, you should only be treated with Sandimmun Neoral if your condition is particularly severe.
Danish: Hvis du er over 65 år og har psoriasis eller atopisk dermatitis, må du kun behandles med Sandimmun Neoral, hvis din tilstand er særlig alvorlig.
English: Since the switch from Sandimmun to Sandimmun Neoral may result in increased exposure to ciclosporin, the following rules must be observed:
Danish: Da skiftet fra Sandimmun til Sandimmun Neoral kan medføre en øget eksponering for ciclosporin, skal følgende regler overholdes:
English: It can also be used to maintain steroid-induced remission, allowing withdrawal of steroids.
Danish: Det kan også bruge til at opretholde steroidinduceret remission, hvorved steroid kan seponeres.
English: Your doctor may give you magnesium supplements to take, especially just after your operation if you have had a transplant.
Danish: Din læge kan ordinere magnesiumtilskud, som du skal tage, specielt lige efter din transplantation.
English: The absolute oral bioavailability of ciclosporin following administration of Sandimmun Neoral is 20 to 50%.
Danish: Ciclosporins absolutte orale biotilgængelighed efter administration af Sandimmun Neoral er 20-50%.
English: The increase in the bioavailability of diclofenac is most probably caused by a reduction of its high first-pass effect.
Danish: Stigningen i diclofenacs biotilgængelighed skyldes sandsynligvis først og fremmest en reduktion i diclofenacs høje first-passeffekt.
English: It is recommended that Sandimmun Neoral be administered on a consistent schedule with regard to time of day and in relation to meals.
Danish: Det anbefales, at Sandimmun Neural administreres efter et konsistent skema med hensyn til tidspunkt på dagen og i forhold til måltider.
English: Your doctor will make sure that you get the right dose for your individual needs.
Danish: Lægen vil sikre, at du får den korrekte dosis, der passer til dine individuelle behov.
English: In nontransplant patients the relationship between blood level and clinical effects is less well established.
Danish: Hos ikke-transplanterede patienter er relationen mellem plasmakoncentration og klinisk effekt mindre etableret.
English: There is a high variability in the data reported on the terminal half-life of ciclosporin depending on the assay applied and on the target population.
Danish: Der er stor variation i de foreliggende data om ciclosporins terminale halveringstid afhængig af den anvendte analyse og målpopulationen.
English: If any of these drugs are used concurrently with ciclosporin, close clinical observation is required in order to enable early detection of toxic manifestations of the medicinal products, followed by reduction of its dosage or its withdrawal.
Danish: Hvis nogle af disse lægemidler bruges sammen med ciclosporin, er tæt klinisk observation nødvendig for at sikre tidlig detektion af toksiske manifestationer af lægemidlet efterfulgt af dosisreduktion eller seponering.
English: Sandimmun Neoral suppresses the immune system and may also affect your body's ability to fight against infection.
Danish: Sandimmun Neoral undertrykker immunsystemet og kan også påvirke kroppens evne til at bekæmpe infektion.
English: There have been reports from clinical trials and from the post-marketing setting associated with the use of Sandimmun Neoral.
Danish: Der har været rapporter fra kliniske studier og postmarketing, relateret til brug af Sandimmun Neoral.