FrancophonIA/ELRC3.0 huggingface dataset:
English: Because Potactasol 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 Potactasol er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: No additional studies were needed as Potactasol is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Hycamtin.
Danish: Der krævedes ingen supplerende undersøgelser, eftersom Potactasol er et generisk lægemiddel, der indgives ved infusion og indeholder det samme aktive stof som referencelægemidlet Hycamtin.
English: The active substance in Potactasol, topotecan, is a cancer medicine that belongs to the group ‘topoisomerase inhibitors'.
Danish: Det aktive stof i Potactasol, topotecan, er et lægemiddel mod kræft, der tilhører gruppen af "topoisomerasehæmmere".
English: When used with cisplatin in cervical cancer, Potactasol is given as an infusion on days 1, 2 and 3 (with cisplatin given on day 1).
Danish: Når Potactasol anvendes sammen med cisplatin til behandling af livmoderhalskræft, indgives det som en infusion på dag 1, 2 og 3 (cisplatin gives på dag 1).
English: Why has Potactasol been approved?
Danish: Hvorfor blev Potactasol godkendt?
English: Potactasol is a medicine that contains the active substance topotecan.
Danish: Potactasol er et lægemiddel, der indeholder det aktive stof topotecan.
English: Therefore, the CHMP's view was that, as for Hycamtin, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici, som for Hycamtin.
English: It is available as a powder to be made up into a solution for infusion (drip) into a vein.
Danish: Det fås som et pulver, der blandes til en opløsning til infusion (drop i en vene).
English: Potactasol is a cancer medicine.
Danish: Potactasol er et lægemiddel mod kræft.
English: What is Potactasol?
Danish: Hvad er Potactasol?
English: What is Potactasol used for?
Danish: Hvad anvendes Potactasol til?
English: How has Potactasol been studied?
Danish: Hvordan blev Potactasol undersøgt?
English: How is Potactasol used?
Danish: Hvordan anvendes Potactasol?
English: How does Potactasol work?
Danish: Hvordan virker Potactasol?
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Danish: BETINGELSER ELLER RESTRIKTIONER MED HENSYN TIL SIKKER OG EFFEKTIV BRUG AF DET MEDICINSKE PRODUKT, DER SKAL IMPLEMENTERES AF MEDLEMSSTATERNE
English: The Member States shall ensure that the MAH provides all doctors who are expected to prescribe MabCampath with a healthcare professional information pack containing the
Danish: Medlemsstaterne skal sikre, at MAH forsyner alle læger, der forventes at foreskrive MabCampath med en professionel sundheds-informationspakke, der indeholder følgende:
English: The Member States must ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product as described below are implemented:
Danish: - Medlemsstaterne skal sikre, at alle betingelser eller restriktioner med hensyn til sikker og effektiv brug af det medicinske produkt som beskrevet nedenfor, implementeres:
English: • The risk of opportunistic infections, in particular CMV viraemia • Recommendation to avoid vaccination with live vaccines for at least 12 months following o That treatment for hypersensitivity reactions, including measures for resuscitation should be available during administration o That the risk of infusion reactions is highest in first week of therapy o That if the reaction is moderate or severe dosing should continue at the same level (ie no dose escalation) until each dose is well tolerated o That if therapy is withheld for more than 7 days then MabCampath should be reinstituted with gradual dose escalation
Danish: forholdsregler for genoplivning o At risikoen for infusionsreaktioner er højest i behandlingens første uge o At såfremt reaktionen er moderat eller alvorlig, bør dosering fortsætte på samme niveau (dvs. ingen dosiseskalering), indtil hver dosis tolereres godt.
English: - To agree the details of an educational brochure with the MAH.
Danish: - At aftale detaljerne i en oplysende brochure med MAH
English: • Summary of Product Characteristics (SPC) and Package Leaflet and Labelling
Danish: ● Resumé af produktkarakteristika (SPC) samt indlægsseddel og etikettering Nøgleelementer der skal inkluderes i den oplysende brochure
English: This summary was last updated on 30/08/2012.
Danish: Dette sammendrag blev sidst ajourført den 30/08/2012.
English: The marketing authorisation was renewed on 2 August 2007.
Danish: Markedsføringstilladelsen blev fornyet den 2. august 2007.
English: It is a solution for injection (0.1 mg/ml and 0.5 mg/ml).
Danish: Det er en injektionsvæske, opløsning (0,1 mg/ml og 0,5 mg/ml).
English: In addition, the blood pressure will increase before returning to normal or below normal.
Danish: Derudover vil blodtrykket først stige og derefter vende tilbage til det normale eller lidt under det normale niveau.
English: Pregnant women should take special care to avoid self-injection.
Danish: Gravide kvinder skal udvise særlig forsigtighed for at undgå selvinjektion.
English: Neurotransmitters are chemicals that allow nerve cells to communicate with each other.
Danish: Neurotransmittere er kemiske stoffer, som sætter nervecellerne i stand til at kommunikere med hinanden.
English: Dexdomitor dexmedetomidine
Danish: Dexdomitor dexmedetomidin
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Dexdomitor on 30 August 2002.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse for Dexdomitor med gyldighed i hele Den Europæiske Union den 30. august 2002.
English: Vomiting may occur five to 10 minutes after injection or at the time of recovery.
Danish: Der kan forekomme opkastning 5-10 minutter efter injektion eller ved opvågning.
English: Other information about Dexdomitor:
Danish: Andre oplysninger om Dexdomitor:
English: The duration and depth of sedation and analgesia depend on the dose that is used.
Danish: Varigheden og dybden af sedationen og analgesien afhænger af, hvilken dosis der anvendes.
English: The use of waterproof gloves is advisable.
Danish: Brug af vandtætte handsker anbefales.
English: It works by preventing the release of the neurotransmitter noradrenaline from nerve cells in the body.
Danish: Det virker ved at hæmme frigivelsen af neurotransmitteren noradrenalin fra kroppens nerveceller.
English: The benefit/risk balance may be found in the scientific discussion module of this EPAR.
Danish: Benefit/risk-forholdet fremgår af afsnittet med den videnskabelige drøftelse i denne EPAR.
English: Since noradrenaline is involved in maintaining alertness and arousal, reducing its release decreases the level of consciousness, including the sensation of pain.
Danish: Da noradrenalin har betydning for evnen til at opretholde vagtsomhed og arousal, vil en reduktion af dets frigivelse mindske bevidsthedsniveauet, herunder også følelsen af smerte.
English: As for medetomidine, ‘good' or ‘excellent' analgesia was reached in about 40 to 50 % of the animals, supporting its used in non-invasive mildly to moderately painful procedures.
Danish: Som ved medetomidin blev der opnået en "god" eller "fremragende" analgesi hos omkring 40 til 50 % af dyrene, hvilket understøtter dets anvendelse ved ikkeinvasive svagt til moderat smertefulde procedurer.
English: Dexdomitor causes a decrease in heart rate and body temperature.
Danish: Dexdomitor forårsager en nedsættelse af hjertefrekvens og legemstemperatur.
English: Dexmedetomidine is an alpha2-adrenoceptor agonist.
Danish: Dexmedetomidin er en α2-adrenoceptor-agonist.
English: It is used in non-invasive procedures which do not involve breaking the skin or a body cavity.
Danish: Det anvendes til ikkeinvasive procedurer, hvilket betyder, at proceduren ikke indebærer brud på huden eller en kropskavitet,
English: However, the person should not drive due to the risk of sedation and changes in blood pressure.
Danish: Kør ikke selv, da sedation og ændringer i blodtryk kan forekomme.
English: • When carrying out mildly to moderately painful procedures and examinations that require the animal to be restrained or sedated and made less sensitive to pain (analgesia).
Danish: • ved udførelse af milde til moderate smertefulde procedurer og undersøgelser, som kræver, at dyret holdes fast eller beroliges, og at det gøres mindre følsom over for smerter (analgesi).
English: Muscle tremors (shaking) and corneal opacities (cloudy spots in the cornea, the clear part of the eye in front of the pupil) may occur during sedation.
Danish: Der kan forekomme muskulære trækninger (rystelser) og corneauklarhed (tågede pletter i cornea, den klare del af øjet foran pupillen) under sedationen.
English: Dexdomitor is used to sedate (calm down) dogs and cats in the following situations:
Danish: Dexdomitor anvendes til at berolige hunde og katte i følgende situationer:
English: • For deep sedation and analgesia in dogs in combination with butorphanol (a sedative and analgesic) for procedures including minor surgery.
Danish: • til dyb sedation og analgesi hos hunde i kombination med butorphanol (et sedativ og analgetisk middel) til procedurer som bl.a. mindre kirurgiske indgreb.
English: The CVMP concluded that the benefits of Dexdomitor exceed the risks and recommended that it be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) fandt, at fordelene ved Dexdomitor opvejer risiciene og anbefalede udstedelse af markedsføringstilladelse for Dexdomitor.
English: Other side effects can occur when Dexdomitor is used with other medicines.
Danish: Der kan forekomme andre bivirkninger, hvis Dexdomitor anvendes sammen med andre lægemidler.
English: The dose is chosen according to the species being treated, the use, whether it is given by intravenous (into a vein) or intramuscular (into a muscle) injection and any other medicines that are also being used.
Danish: Dosis vælges afhængigt af, hvilken art der behandles, hvad det anvendes til, hvorvidt det gives som intravenøs injektion (i en vene) eller intramuskulær injektion (i en muskel), og hvilke eventuelle andre lægemidler, som også anvendes.
English: The safety of the use of Dexdomitor has not been studied in puppies below 16 weeks of age or in kittens below 12 weeks of age.
Danish: Sikkerheden ved brug af Dexdomitor til hvalpe under 16 uger eller killinger under 12 uger er ikke blevet undersøgt.
English: When used in cats, ketamine should be used as the anaesthetic agent.
Danish: Når det anvendes til katte, bør der anvendes ketamin som anæstesistof,
English: In cats, it is given by intramuscular injection.
Danish: Hos katte gives det ved intramuskulær injektion.
English: What is the risk associated with Dexdomitor?
Danish: Hvilken risiko er der forbundet med Dexdomitor?
English: Dexdomitor contains the active substance dexmedetomidine, which belongs to a class of medicines having a psycholeptic (sedative) action.
Danish: Dexdomitor indeholder det aktive stof dexmedetomidin, der tilhører en klasse lægemidler med psykoleptisk (sedativ) virkning.
English: The studies included dogs and cats of various ages and breeds, which were undergoing procedures requiring sedation or analgesia.
Danish: Undersøgelserne omfattede hunde og katte af forskellige aldre og racer, som gennemgik procedurer, der krævede sedation eller smertelindring.
English: Why has Dexdomitor been approved?
Danish: Hvorfor blev Dexdomitor godkendt?
English: If contact does occur, rinsing with large amounts of water is advised.
Danish: Sker det alligevel, anbefales det straks at vaske det berørte område med rigeligt vand.
English: In some dogs and cats, there may be a decrease in breathing rate and the mucous membranes may appear pale or with a blue tinge.
Danish: Hos nogle hunde og katte kan der forekomme en nedsættelse af respirationsfrekvensen, og der kan ses et blegt eller blåligt skær på slimhinderne.
English: Dexmedetomidine is closely related to another substance used to sedate animals, medetomidine, that has been used in veterinary medicine for many years.
Danish: Dexmedetomidin er nært forbundet med et andet stof, medetomidin, som også anvendes til sedation af dyr, og som har været anvendt i veterinærlægemidler i mange år.
English: It should not be used in animals that have problems with their heart or blood vessels, with severe systemic (whole body) disease, that are moribund (close to death) or that are known to be hypersensitive (allergic) to dexmedetomidine or any of the other ingredients.
Danish: Det bør ikke anvendes til dyr med kardiovaskulære lidelser eller til dyr, som lider af alvorlige systemiske lidelser (hele kroppen) eller er døende, eller som vides at være overfølsomme over for dexmedetomidin eller andre af indholdsstofferne.
English: Dexdomitor was investigated in studies involving dogs and cats in which its effectiveness was compared with that of medetomidine.
Danish: Dexdomitor blev undersøgt i undersøgelser, der omfattede hunde og katte, hvor dets effekt blev sammenlignet med effekten af medetomidin.
English: What is Dexdomitor?
Danish: Hvad er Dexdomitor?
English: The dose depends on the body surface area in dogs (calculated using bodyweight) and bodyweight in cats.
Danish: Dosis afhænger hos hunde af kropsoverfladen (beregnet ud fra legemsvægten) og hos katte af legemsvægten.
English: Finally, it was studied as a premedication in dogs and cats prior to induction of general anaesthesia.
Danish: Endelig blev det undersøgt som præmedicinering til hunde og katte inden påbegyndelse af fuld narkose.
English: • Before inducing general anaesthesia.
Danish: • inden brug af fuld narkose.
English: In dogs, both intravenous and intramuscular injections of Dexdomitor were studied.
Danish: Hos hunde undersøgte man både intravenøse og intramuskulære injektioner af Dexdomitor.
English: People who are known to be hypersensitive to dexmedetomidine or any of the other ingredients should give the medicine with caution.
Danish: Personer, der er overfølsomme over for dexmedetomidin eller andre af indholdsstofferne, bør udvise forsigtighed i forbindelse med indgivelse af stoffet.
English: The studies showed that Dexdomitor had an equivalent level of effectiveness as medetomidine in inducing sedation and analgesia in dogs and cats.
Danish: Undersøgelserne viste, at Dexdomitor var lige så effektiv som medetomidin til fremkaldelse af sedation og analgesi i hunde og katte.
English: In dogs, Dexdomitor is given by intravenous or intramuscular injection.
Danish: Hos hunde gives Dexdomitor ved intravenøs eller intramuskulær injektion.
English: If Dexdomitor is accidentally self-injected or taken by mouth, medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
Danish: I tilfælde af uagtsom selvinjektion eller oral indtagelse af Dexdomitor skal der straks søges lægehjælp, og indlægssedlen skal vises til lægen.
English: What is Dexdomitor used for?
Danish: Hvad anvendes Dexdomitor til?
English: For a full list of all side effects reported with Dexdomitor, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Dexdomitor fremgår af indlægssedlen.
English: Dexdomitor also showed adequate effectiveness for deep sedation of dogs in combination with butorphanol, and for premedication in dogs and cats before induction of general anaesthesia, reducing the amount of anaesthetic that the dogs and cats require.
Danish: Dexdomitor var også tilstrækkelig effektiv til dyb sedation af hunde i kombination med butorphanol og til præmedicinering inden påbegyndelse af fuld narkose, hvorved den nødvendige mængde af bedøvelsesmidlet, som hunde og katte havde behov for, mindskedes.
English: Dexdomitor was at least as effective as medetomidine in inducing general anaesthesia in cats in combination with ketamine.
Danish: Dexdomitor var mindst lige så effektiv som medetomidin til iværksættelse af fuld narkose hos katte i kombination med ketamin.
English: How has Dexdomitor been studied?
Danish: Hvordan blev Dexdomitor undersøgt?
English: How does Dexdomitor work?
Danish: Hvordan virker Dexdomitor?
English: What benefit has Dexdomitor shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Dexdomitor?
English: Dexdomitor was also compared with medetomidne for premedication (sedation prior to anaesthesia) in cats about to undergo general anaesthesia with ketamine and for deep sedation of dogs in combination with butorphanol.
Danish: Dexdomitor blev også sammenlignet med medetomidin anvendt som præmedicinering til katte inden fuld narkose med ketamin og til dyb sedation og af hunde i kombination med butorphanol.
English: Contact with the skin, eyes of mucous (moist body surfaces) should be avoided.
Danish: Undgå kontakt med hud, øjne og slimhinder.
English: 60 sachets + 2 syringes (1 ml) + 2 syringes (3 ml) + 2 syringes (10 ml) + 2 mixing cups
Danish: 60 folieposer + 2 sprøjter (1 ml) + 2 sprøjter (3 ml) + 2 sprøjter (10 ml) + 2 blandebægre
English: Granules for oral suspension sachet (PET/Alu/LLDPE)
Danish: Oral anvendelse foliepose (PET/alu/LLDPE)
English: Outcome of re-examination
Danish: Resultat af revurdering
English: 21 March 2014 EMA/167920/2014 EMEA/H/C/002670
Danish: Den 21. marts 2014 EMA/167920/2014 EMEA/H/C/002670
English: What is Masican?
Danish: Hvad er Masican?
English: For more information, see here.
Danish: Yderligere information findes her.
English: The study was a ‘phase II study', an exploratory study designed to see if a medicine is worth investigating further.
Danish: Undersøgelsen var en “fase II-undersøgelse”, dvs. en sonderende undersøgelse, der er udformet til at afgøre, hvorvidt et lægemiddel er værd at undersøge yderligere.
English: In addition, there were still outstanding problems related to quality control during its manufacture.
Danish: Dertil kom, at der stadig var udestående problemer vedrørende kvalitetskontrollen under fremstillingen.
English: Therefore, the Committee concluded that there were insufficient data to establish the benefits of Masican.
Danish: Udvalget konkluderede derfor, at der ikke var tilstrækkelige data til at fastslå fordelene ved Masican.
English: How is Masican expected to work?
Danish: Hvordan forventes Masican at virke?
English: Refusal of the marketing authorisation for Masican (masitinib) EMA/167920/2014
Danish: Afslag på ansøgningen om markedsføringstilladelse for Masican (masitinib) EMA/167920/2014
English: Finally, there were concerns about the quality control of the medicine during manufacture, which led to uncertainties about the impurities that patients would be exposed to.
Danish: Endelig var der betænkelighed ved kvalitetskontrollen med lægemidlet under fremstillingen, hvilket medførte usikkerhed vedrørende de urenheder, som patienterne ville blive udsat for.
English: Refusal of the marketing authorisation for Masican (masitinib)
Danish: Afslag på ansøgningen om markedsføringstilladelse for Masican (masitinib)
English: What was Masican expected to be used for?
Danish: Hvad forventedes Masican anvendt til?
English: By blocking these receptors, Masican might help in controlling cell division and thereby slow down the growth of the cancer.
Danish: Ved at hæmme disse receptorer kan Masican muligvis bidrage til at hæmme celledelingen og dermed bremse kræftens vækst.
English: At the time of the initial evaluation, the CHMP was concerned that the study was not designed to compare Masican with sunitinib and that it was difficult to interpret the results.
Danish: På tidspunktet for den første vurdering var der i CHMP betænkelighed ved, at undersøgelsen ikke var udformet med henblik på at sammenligne Masican med sunitinib, og at det var vanskeligt at fortolke resultaterne.
English: On 21 November 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Masican, intended for the treatment of malignant gastrointestinal stromal tumour (GIST).
Danish: Den 21. november 2013 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse og anbefalede afslag på ansøgningen om markedsføringstilladelse for lægemidlet Masican, der var bestemt til behandling af ondartet gastrointestinal stromal tumor (GIST).
English: Masican is an anticancer medicine that contains the active substance masitinib.
Danish: Masican er et kræftlægemiddel, der indeholder det aktive stof masitinib.
English: The study included a group of patients treated with Masican and one group treated with sunitinib, another medicine of the same class.
Danish: Undersøgelsen omfattede en gruppe patienter, der blev behandlet med Masican, og en gruppe patienter, der blev behandlet med sunitinib, som er et andet lægemiddel i samme klasse.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 20 March 2014.
Danish: Efter at have gennemgået begrundelsen for anmodningen foretog CHMP en revurdering af den første udtalelse og fastholdt den 20. marts 2014 afslaget på ansøgningen om markedsføringstilladelse.
English: Therefore the CHMP concluded that the benefits of Masican did not outweigh its risks and maintained the previous recommendation that the medicine be refused marketing authorisation.
Danish: CHMP besluttede derfor, at fordelene ved Masican ikke opvejede risiciene, og fastholdt sin tidligere anbefaling om at give afslag på ansøgningen om en markedsføringstilladelse.
English: The active substance in Masican, masitinib, is a tyrosine-kinase inhibitor.
Danish: Det aktive stof i Masican, masitinib, er en tyrosinkinasehæmmer.
English: The CHMP was also concerned that safety data were only available for a few patients treated with Masican at the proposed dose and this did not allow a proper evaluation of the medicine's side effects.
Danish: I CHMP var der desuden betænkelighed ved, at der kun fandtes sikkerhedsdata for nogle få patienter behandlet med Masican i den ansøgte dosis, så der ikke var mulighed for en egentlig vurdering af lægemidlets bivirkninger.
English: The main measure of effectiveness was progression-free survival (how long the patients lived without the disease getting worse).
Danish: Behandlingens virkning blev hovedsagelig bedømt på, hvor længe patienterne overlevede uden forværring af sygdommen (progressionsfri overlevelse).
English: Masican was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 21 December 2004 for the treatment of malignant GIST.
Danish: Masican blev udpeget som “lægemiddel til sjældne sygdomme” til behandling af ondartet GIST den 21. december 2004.
English: Although the group of patients treated with Masican appeared to live longer than those treated with sunitinib, the possibility that this was a chance finding could not be ruled out because of the exploratory nature of the study and because other supportive evidence was lacking.
Danish: Skønt den gruppe patienter, der blev behandlet med Masican, syntes at leve længere end dem, der blev behandlet med sunitinib, kunne det ikke udelukkes, at dette skyldtes en tilfældighed, fordi der var tale om en sonderende undersøgelser, og fordi der manglede anden støttende dokumentation.
English: The applicant presented results of a main study in 44 patients with GIST that could not be removed surgically or that had spread and was resistant to imatinib treatment.
Danish: Ansøgeren fremlagde resultaterne af en hovedundersøgelse hos 44 patienter med GIST, der ikke kunne fjernes ved operation, havde bredt sig eller var blevet modstandsdygtig mod behandling med imatinib.
English: surface of cancer cells, including the receptors that are involved in stimulating the cells to divide uncontrollably.
Danish: herunder de receptorer, der medvirker til at stimulere cellerne til at dele sig ukontrolleret.