FrancophonIA/ELRC3.0 huggingface dataset:
English: For further details see the package leaflet.
Danish: Yderligere oplysninger fremgår af indlægssedlen.
English: How has Evicel been studied?
Danish: Hvordan blev Evicel undersøgt?
English: It can also be used in addition to sutures (stitching) during vascular surgery (surgery on the blood vessels).
Danish: Det kan også anvendes som støttebehandling i forbindelse med suturer (sting) under karkirurgi (kirurgisk indgreb i blodkarrene).
English: In vascular surgery, 85% of the patients had no bleeding four minutes after treatment with Evicel (64 out of 75), compared with 39% of the patients treated with manual compression (28 out of 72).
Danish: Evicel var mere effektivt til at dæmpe blødninger på applikationsstedet end de præparater, det blev sammenlignet med. Ved karkirurgi havde 85 % af patienterne ingen blødninger fire minutter efter behandlingen med Evicel (64 ud af 75) sammenlignet med 39 % af de patienter, der blev behandlet med manuel kompression (28 ud af 72).
English: Evicel must also not be used in dura mater closure if the dura mater cannot be sutured, or if there are gaps greater than 2 mm after suturing.
Danish: Evicel må heller ikke anvendes til lukning af dura mater, hvis denne ikke kan sutureres, eller hvis der efter suturering er mellemrum på mere end 2 mm. Evicel må desuden ikke anvendes som klæbemiddel til fiksering af dura-plastre (materiale, der sys på en åbning i dura mater).
English: How is Evicel used?
Danish: Hvordan anvendes Evicel?
English: What benefit has Evicel shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Evicel?
English: When used in endoscopic procedures (procedures that use an endoscope for viewing internal organs),
Danish: Ved endoskopiske indgreb (indgreb med anvendelse af et endoskop til at undersøge de indre organer) må Evicel ikke gives som spray.
English: How does Evicel work?
Danish: Hvordan virker Evicel?
English: Avoid contact with eyes.
Danish: Undgå kontakt med øjne.
English: This transformation is responsible for the potency of the therapeutic class.
Danish: Denne omdannelse er ansvarlig for potens af denne terapeutiske gruppe.
English: Oostkamp Belgium
Danish: Oostkamp Belgien
English: Cardboard box containing 1 bottle of 76 ml.
Danish: Kartonæske indeholdende 1 flaske med 76 ml.
English: ATC vet code: QD07AC16.
Danish: ATCvet-kode: QD07AC16.
English: This veterinary medicinal product is flammable.
Danish: Dette veterinærlægemiddel er brændbart.
English: Bioglan AB Borrgatan 31 211 24 Malmo Sweden
Danish: Bioglan AB Borrgatan 31 21124 Malmö Sverige
English: Before administration, screw the pump spray on the bottle.
Danish: Før administrationen skrues spraypumpen på flasken.
English: If signs fail to improve within 7 days, treatment should be re-evaluated by the veterinarian.
Danish: Hvis symptomerne ikke bedres i løbet af 7 dage, bør behandlingen reevalueres af dyrlægen.
English: Allow the application site to dry before permitting contact with such materials.
Danish: Det behandlede område bør tørre, inden man tillader kontakt med disse materialer.
English: The solvent in this product may stain certain materials including painted, varnished or other household surfaces or furnishings.
Danish: Solvensen i dette produkt kan plette på visse materialer, såsom malede, lakerede eller andre husholdningsoverflader og møbler.
English: This particularity will increase the ratio between the desired local antiinflammatory effect in the skin and the undesirable systemic effects.
Danish: Dette øger specielt forholdet imellem den ønskede lokale antiinflammatoriske virkning i huden og den uønskede systemiske virkning.
English: Topical application of diesters results in high therapeutic index: high local activity with reduced systemic secondary effects.
Danish: Topikal applikation af diestre resulterer i et højt terapeutisk indeks: Høj lokal aktivitet med begrænset sekundær systemisk virkning.
English: The diesters are transformed inside the skin structures.
Danish: Diestrene omdannes i huden.
English: Care should be taken to avoid spraying into the eyes of the animal.
Danish: Der skal drages omhu for at undgå at sprøjte i dyrets øjne.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: In the absence of information, it is recommended not to apply other topical preparations simultaneously on the same lesions.
Danish: På grund af manglende data anbefales det ikke at applicere andre topikale præparater samtidigt på den samme læsion.
English: In the case of concurrent microbial disease or parasitic infestation, the dog should receive appropriate treatment for such condition.
Danish: I tilfælde af samtidig mikrobiel infektion eller parasitær infestation skal hunden have passende behandling for disse tilstande.
English: Do not use after the expiry date stated on the label.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på etiketten efter EXP.
English: 10 DATE OF REVISION OF THE TEXT <{MM/YYYY}> <{DD/MM/YYYY}> <{DD month YYYY}>
Danish: <{måneder/år}> <{DD / MM / ÅÅÅÅ}> <{DD måned ÅÅÅÅ}.>
English: Prime the pump before administration.
Danish: Pumpen skal primes (afprøves) inden administration.
English: Flammable.
Danish: Brandbart.
English: Do not smoke while handling the product.
Danish: Undlad at ryge, mens produktet håndteres.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27/08/2018
Danish: Dato for første markedsføringstilladelse: 27/08/2018
English: The veterinary medicinal product contains the active substance hydrocortisone aceponate.
Danish: Det veterinære lægemiddel indeholder det aktive stof hydrocortisonaceponat.
English: PSUR submissions shall be synchronised and submitted at the same frequency as for the reference product.
Danish: Krav til lægemiddelovervågning: PSUR'erne skal indsendes med samme hyppighed som for referenceproduktet.
English: Systemic absorption of hydrocortisone aceponate being negligible, it is unlikely for teratogenic, foetotoxic, maternotoxic effects to happen at the recommended dosage in dogs.
Danish: Systemisk absorption af hydrocortisonaceponat er ubetydelig, derfor er det usandsynligt, at der forekommer teratogen, foetotoxisk eller maternotoxisk effekt ved den anbefalede dosering hos hunde.
English: Presented as a volatile spray, this veterinary medicinal product does not require any massage.
Danish: På grund af formuleringen som en flygtig spray behøver dette produkt ikke masseres ind i huden.
English: D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Danish: D. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
English: Tolerance studies using 3 and 5 times the recommended dosage for twice the recommended duration of treatment resulted in a reduced capacity for production of cortisol that is fully reversible within 7 to 9 weeks after the end of treatment.
Danish: Tolerancestudier med 3 og 5 gange den anbefalede dosis i dobbelt så lang tid som den anbefalede varighed af behandlingen resulterede i en reduceret kapacitet for produktion af cortisol, som normaliseredes 7 til 9 uger efter behandlingen.
English: MANUFACTURER'S BATCH NUMBER Lot
Danish: FREMSTILLERENS BATCHNUMMER
English: This results in minimal amounts to reach the blood stream.
Danish: Dette betyder, at minimale mængder af det aktive stof når blodbanen.
English: Hydrocortisone aceponate applications on the skin lesions provide rapid reduction of the skin redness, irritation and scratching while minimising the general effects.
Danish: Hydrocortisonaceponat applikationer på hudlæsioner medfører hurtig reduktion af rødmen, irritation og kløe, samtidigt med at den generelle virkning er minimal.
English: Hydrocortisone aceponate belongs to the diesters class of the glucocorticosteroids.
Danish: Hydrocortisonaceponat tilhører diestergruppen af glucocorticosteroider.
English: Spray preferably in a well ventilated area.
Danish: Anvend produktet i et område med god ventilation.
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Danish: Veterinærlægemiddelts sikkerhed under drægtighed og laktation er ikke fastlagt.
English: Active substance
Danish: Aktivt stof:
English: Since glucocorticosteroids are known to slow growth, use in young animals (under 7 months of age) shall be based on the riskbenefit assessment and subject to regular clinical evaluations.
Danish: Fordi glucokorticosteroider er kendt for at hæmme vækst, bør anvendelse til unge dyr (under 7 måneder) baseres på en benefit-risk vurdering samt en normal klinisk evaluering.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of solution contains:
Danish: Én ml opløsning indeholder:
English: In laboratory animals, hydrocortisone aceponate is eliminated the same way as hydrocortisone (other name for endogenous cortisol) through urine and faeces.
Danish: Hos laboratoriedyr elimineres hydrocortisonaceponat ad samme rute som hydrocortison (et andet navn for endogen cortisol) via urin og fæces.
English: The diesters are lipophilic components ensuring an enhanced penetration into the skin associated to a low plasma availability.
Danish: Diestrene er lipofile stoffer, som sikrer en god penetration af huden samtidigt med en lav plasmatilgængelighed.
English: White polyethylene terephthalate (PET) bottle closed with a white polypropylene screw cap with bore seal and supplied with a spray pump.
Danish: Hvid flaske af polyetylenterephthalat (PET) lukket med et hvidt skruelåg af polypropylen med forsegling og leveret med en spray-pumpe.
English: Manufacturer responsible for batch release: Bioglan AB
Danish: Fremstiller ansvarlig for batchfrigivelse Bioglan AB
English: MARKETING AUTHORISATION NUMBER(S) EU/2/18/230/001
Danish: EU/2/18/230/001
English: In case of eye irritation, seek medical advice.
Danish: Ved irritation i øjnene skal der søges læge.
English: Read the package leaflet before use.
Danish: Læs indlægssedlen før brugen.
English: Pharmacotherapeutic group: Corticosteroids, dermatological preparations.
Danish: Farmakoterapeutisk gruppe: Corticosteroider,
English: Hydrocortisone aceponate administered topically accumulates and is metabolised in skin, as suggested by radioactivity distribution studies and pharmacokinetic data.
Danish: Hydrocortisonaceponat der administreres på huden akkumuleres og omsættes i huden, som vist ved studier med radiomærket stof og farmakokinetiske data.
English: 4.7 Use during pregnancy, lactation or lay
Danish: 4.7 Anvendelse under drægtighed, diegivning eller æglægning
English: Hydrocortisone aceponate thus accumulates in the dog's skin allowing local efficacy at low dosage.
Danish: Hydrocortisonaceponat akkumuleres derfor i hundens hud, hvilket giver lokal effekt, selv ved lave doser.
English: In case of accidental skin contact, wash thoroughly with water.
Danish: I tilfælde af hudkontakt ved hændeligt uheld, vaskes grundigt med vand.
English: Clear colourless to slightly yellow solution.
Danish: Klar, farveløs til let gullig opløsning.
English: Use only accordingly to the risk-benefit assessment by the responsible veterinarian.
Danish: Må kun anvendes i overensstemmelse med den ansvarlige dyrlæges vurdering af benefit-risk forholdet.
English: In the absence of specific information, the use in animal suffering from Cushing's syndrome shall be based on the risk-benefit assessment.
Danish: På grund af manglende specifikke data bør anvendelse til dyr, som lider af Cushings syndrom, baseres på en benefit-risk vurdering.
English: Shelf-life after first opening the container: 6 months
Danish: Holdbarhed efter første åbning af beholderen: 6 måneder.
English: In 12 dogs suffering from atopic dermatitis, after topical application on the skin at the recommended therapeutic dosage for 28 to 70 consecutive days, no noticeable effect on the systemic cortisol level was observed.
Danish: Hos 12 hunde, der led af atopisk dermatitis, blev der ikke observeret nogen særlig effekt på det systemiske kortisolniveau efter topikal applikation på huden med den anbefalede dosering i 28 til 70 på hinanden følgende dage.
English: The recommended dosage is 1.52 µg of hydrocortisone aceponate/cm2 of affected skin per day.
Danish: Den anbefalede dosering er 1,52 µg hydrocortisonaceponat/cm2 hud pr. dag.
English: Overdose (symptoms, emergency procedures, antidotes):
Danish: Overdosering (symptomer, nødforanstaltninger, modgift), om nødvendigt
English: PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable.
Danish: FORBUD MOD SALG, UDLEVERING/BRUG
English: Do not smoke while handling the veterinary medicinal product.
Danish: Undlad tobaksrygning, mens veterinærlægemidlet håndteres.
English: For symptomatic treatment of inflammatory and pruritic dermatoses in dogs.
Danish: Symptomatisk behandling af inflammatoriske og kløende dermatoser hos hunde.
English: Transient local reactions at the application site (erythema and/or pruritus) can occur in very rare cases.
Danish: I meget sjældne tilfælde kan der forekomme forbigående lokale reaktioner (rødme og/eller kløe) på applikationsstedet.
English: Do not spray on naked flame or any incandescent material.
Danish: Undlad at spraye over åben ild eller antændeligt materiale.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE OUTER CARTON
Danish: OPLYSNINGER DER SKAL FREMGÅ PÅ DEN YDRE PAKNING
English: In case of accidental ingestion, seek medical advice immediately and show the leaflet or the label to the physician.
Danish: Ved utilsigtet indtagelse skal der søges læge straks, og lægemidlets indlægsseddel eller etiket skal vises til lægen.
English: After topical application on the skin at the recommended therapeutic dosage and twice the recommended duration of treatment and at up to a body surface corresponding to the two flanks, from the spine to the mammary chains including the shoulder and the thighs, no systemic effects are observed.
Danish: Efter topikal applicering i den anbefalede dosis, men i den dobbelte behandlingsvarighed af det anbefalede, og på et overfladeareal der svarer til begge flanker, fra rygraden til mælkekirtlerne inklusive skuldre og lår, observeredes ingen systemisk effekt.
English: In case of accidental eye contact, rinse with abundant quantities of water.
Danish: Ved utilsigtet øjenkontakt vaskes med rigelige mængder rent vand.
English: Do not use on cutaneous ulcers.
Danish: Må ikke anvendes på hudulcerationer.
English: C. STATEMENT OF THE MRLs Not applicable.
Danish: C. ANGIVELSE AF MRL-VÆRDIER
English: The total body surface treated should not exceed a surface corresponding for example to a treatment of two flanks from the spine to the mammary chains including the shoulders and the thighs.
Danish: Den totale behandling af kroppens overflade bør ikke overstige et areal som svarer til f.eks. behandling af begge flanker fra rygraden til mælkekirtlerne, og som inkluderer skuldre og hofter.
English: In case of conditions requiring an extended treatment, the responsible veterinarian should subject the use of the veterinary medicinal product to the risk-benefit assessment.
Danish: I tilfælde af behov for forlænget behandling bør dyrlægen basere behandlingen på en benefit-risk vurdering.
English: Propylene glycol methyl ether.
Danish: Propylenglycolmethylæter.
English: Otherwise, use only according to the risk-benefit assessment and subject the dog to regular clinical evaluations.
Danish: Ellers bør anvendelse kun ske i forhold til en vurdering af fordele og risici og efter normal klinisk evaluering.
English: Hydrocortisone aceponate is a dermocorticoid with a potent intrinsic glucocorticoid activity which means a relief of both inflammation and pruritus leading to a quick improvement of skin lesions observed in case of inflammatory and pruritic dermatosis.
Danish: Hydrocortisonaceponat er et dermocorticoid med en potent glucocorticoid virkning, som bedrer både inflammation og pruritus.
English: EXP {month/year} Once opened, use within 6 months.
Danish: EXP {måned/år} Skal anvendes inden 6 måneder efter anbrud.
English: The veterinary medicinal product is then applied by activating the pump spray, from a distance of about 10 cm of the area to be treated.
Danish: Sprayflasken holdes i en afstand af ca. 10 cm fra det område, som ønskes behandlet.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG.
English: STATEMENT OF ACTIVE SUBSTANCES Each ml contains 0.584 mg of hydrocortisone aceponate.
Danish: Hver ml indeholder 0,584 mg hydrocortisonaceponat.
English: Pregnancy and lactation:
Danish: Kutanspray, opløsning.
English: Hydrocortisone aceponate 0.584 mg Equivalent to 0.460 mg of hydrocortisone For the full list of excipients, see section 6.1.
Danish: Hydrocortisonaceponat 0,584 mg Svarende til 0,460 mg hydrocortison.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE BOTTLE (PET)
Danish: Flaske (PET)
English: Total body surface treated should not exceed a surface corresponding for example to a treatment of two flanks from the spine to the mammary chains including the shoulders and the thighs.
Danish: Særlige advarsler for hver enkelt dyreart, som lægemidlet er beregnet til Total behandling af kroppens overflade bør ikke overstige et areal som svarer til f.eks. behandling af begge flanker fra rygraden til mælkekirtlerne, og som inkluderer skuldre og hofter.
English: This dosage can be achieved with two pump spray activations over a surface to be treated equivalent to a square of 10 cm x 10 cm. Repeat the treatment daily for 7 consecutive days.
Danish: Denne dosis opnås ved to pumpeslag pr. 10 x 10 cm hud.
English: PACKAGE LEAFLET: Cortacare 0.584 mg/ml cutaneous spray solution for dogs
Danish: Cortacare 0,584 mg/ml kutanspray, opløsning til hund
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Cortacare 0.584 mg/ml cutaneous spray solution for dogs hydrocortisone aceponate
Danish: Cortacare 0,584 mg/ml kutanspray, opløsning til hund hydrocortisonaceponat
English: METHOD AND ROUTE(S) OF ADMINISTRATION Cutaneous use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E)
English: The recommended dosage is 1.52 µg of
Danish: Den anbefalede dosering er 1,52 µg hydrocortisonaceponat/cm hud pr. dag.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Cortacare 0.584 mg/ml cutaneous spray solution for dogs.
Danish: Cortacare 0,584 mg/ml kutanspray, opløsning til hund.
English: For animal treatment only.
Danish: Til dyr - kræver recept.
English: In total, about 9,800 patients have been followed up for six years.
Danish: I alt er omkring 9 800 patienter blevet fulgt i seks år.
English: The European Commission issued a decision on 6 August 2010.
Danish: Europa-Kommissionen traf en afgørelse den 6. august 2010.
English: On the basis of these data, the German medicines regulatory agency (BfArM) triggered in November 2009 a review under Article 107 of Directive 2001/83/EC.
Danish: På grundlag af disse data foranstaltede den tyske lægemiddelstyrelse (BfArM) i november 2009 en revurdering i henhold til artikel 107 i direktiv 2001/83/EF.
English: 1 Afibon, Ectiva, Lindaxa, Meissa, Meridia, Minimacin, Minimectil, Obesan, Sibutral, Sibutril, Siluton, Sitrane, Redoxade, Zelixa and Zelium.
Danish: 1 Afibon, Ectiva, Lindaxa, Meissa, Meridia, Minimacin, Minimectil, Obesan, Sibutral, Sibutril, Siluton, Sitrane, Redoxade, Zelixa og Zelium.
English: Sibutramine-containing medicines have been authorised in the European Union (EU) since 1999.
Danish: Lægemidler indeholdende sibutramin har været godkendt i Den Europæiske Union (EU) siden 1999.
English: Questions and answers on the suspension of medicines containing sibutramine
Danish: Spørgsmål og svar vedrørende suspendering af lægemidler indeholdende sibutramin
English: They should also review the treatment of patients currently treated with the medicine.
Danish: De bør desuden revurdere behandlingen af patienter, som aktuelt behandles med lægemidlet.
English: What is sibutramine?
Danish: Hvad er sibutramin?
English: The Committee also asked the company to provide six-monthly updates on the progress of the study.
Danish: Udvalget bad desuden virksomheden om at levere halvårlige opdateringer om undersøgelsens forløb.
English: Patients who wish to stop treatment before seeing their doctor can do so at any time.
Danish: Patienter, der ønsker at afslutte behandlingen, inden de har talt med deres læge, kan til enhver tid gøre dette.
English: The CHMP reviewed the responses from the company to a list of questions on the SCOUT study.
Danish: CHMP vurderede de svar, som virksomheden havde givet på en række spørgsmål om SCOUTundersøgelsen.
English: The increased levels of neurotransmitters in the brain help patients to feel full after a meal, and this helps to reduce their food intake.
Danish: Den øgede koncentration af neurotransmittere i hjernen får patienterne til at føle mæthed efter måltiderne, hvilket medvirker til at reducere deres indtagelse af mad.
English: They are available as capsules containing 10 mg or 15 mg sibutramine, under the trade names Reductil and other names1, and as generic medicines.
Danish: De fås som kapsler indeholdende 10 mg eller 15 mg sibutramin under særnavnet Reductil og andre navne1 samt som generiske lægemidler.
English: By blocking their re-uptake, sibutramine increases the amount of these neurotransmitters in the brain.
Danish: Ved at blokere for genoptagelsen af disse stoffer øger sibutramin mængden af neurotransmittere i hjernen.
English: It works by preventing the neurotransmitters 5-hydroxytryptamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain.
Danish: Det virker ved at forhindre neurotransmitterne 5-hydroxytryptamin (også kaldet serotonin) og noradrenalin i at blive genoptaget i nerveceller i hjernen.
English: The Committee also noted that it is not clear if this effect on weight loss can be maintained when sibutramine treatment is stopped.
Danish: Udvalget bemærkede desuden, at det ikke står klart, hvorvidt denne virkning på vægttabet kan opretholdes, når behandlingen med sibutramin afsluttes.
English: Why was sibutramine reviewed?
Danish: Hvorfor blev sibutramin vurderet igen?
English: They are used, alongside diet and exercise, in patients who are obese (very overweight) with a body mass index (BMI) greater than or equal to 30 kg/m², and in patients who are overweight (with a BMI greater than or equal to 27 kg/m²) and also have other obesity-related risk factors, such as type 2 diabetes or dyslipidaemia (abnormal levels of fat in the blood).
Danish: De anvendes sideløbende med diæt og motion til patienter, som er adipøse (svært overvægtige), det vil sige med et kropsmasseindeks (BMI) på 30 kg/m² eller derover, og patienter, som er overvægtige (med et BMI på 27 kg/m² eller derover), og som også har andre fedmerelaterede risikofaktorer, såsom type 2-diabetes eller dyslipidæmi (unormalt højt fedtindhold i blodet).
English: Sibutramine is a ‘serotonin-noradrenaline re-uptake inhibitor' (SNRI).
Danish: Sibutramin er en "serotonin-noradrenalin genoptagelseshæmmer" (SNRI).
English: Sibutramine was originally reviewed by the Agency in 1999 and 2002, following concerns over its safety, especially cardiovascular side effects (increased blood pressure and heart rate).
Danish: Sibutramin blev oprindeligt vurderet af agenturet i 1999 og 2002, efter at der var udtrykt betænkeligheder ved dets sikkerhed, særligt dets kardiovaskulære bivirkninger (forhøjet blodtryk
English: The suspension will remain in place until the company can provide data that are sufficient to allow the identification of a group of patients for whom sibutramine's benefits clearly outweigh its risks.
Danish: Suspenderingen opretholdes, indtil virksomheden kan fremlægge tilstrækkeligt med data til at identificere en patientgruppe, hos hvem fordelene ved sibutramin klart opvejer risiciene.
English: The Committee also consulted a group of experts specialising in the treatment of metabolic diseases.
Danish: Udvalget rådførte sig desuden med en gruppe eksperter i behandling af stofskiftesygdomme.